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1. 48 CALCULATING 5 120 2422 2022 0 0 000000 49 CALCULATING PLATELET 53 ANALYSIS aa a eie reU 56 260958 uova aora ene See UE a Lon 58 CYTOCHEMICAL REACTIONS cccsessscecececeessaececececsensaaececececeeseaaececececseseaeeeseeeeseneaaees 58 ADVIA 2120 21201 AUTORETIC 58 eerte oerte eee doe ee deese ta ce reete cce 58 RETICULOCYTE METHOD NOMENCLATURE cete eren eterne eene tnn nnne nennen 59 RETIC RATE HISTOGR M nice eua EE snide VEREOR E EVER Ee RENT 59 RETIC ABS FLATNESS 60 RETIC ABS HISTOGRAM ccccssssseccecececsssseaececececeenseaececeeeceessnacaecececsessaaeaececeesesenaees 60 RETIC VOLUME HISTOGRAM R geo T 60 RETICHC HISTOGRAM rrt rre He eee Ue Pe HG ER e PE IP s 61 RETIC CH HISTOGRAM e peer erre ene o 63 RETIC SCATTER ABS 64 RETIC V HC CYTOGRAM R E ERR EE EAR E vw ea EG 65 RETIC SCATTER CYTOGRAM 5 Pe UR e
2. tai b E 22 CALCULATING 8 1 2 2 26 00 001000000000000000000000 23 5 2250 40 25 CYTOCHEMICAL 8 0 0000000000100000000000000000000 0 25 ADVIA 2120 21201 1 25 gt gt passer ose ee a Beets 26 ADVIA 2120 21 20EPEROX 35 cacao aeter ie RR EIE d 26 ADVIA 2120 21201 5 26 MEASUREMENT 5 26 PEROX RATE HISTOGRAM sineira e a E EAT E N A 27 PEROX X HISTOGRAM a rete e eu este e eee e RE E ES 27 PEROX Y HISTOGRAM ccccsccccccecsesssececececeesssaececececeeseaaececececeessaaesecececeeseaaeceseeeeseneaees 28 NOISE LYMPH HISTOGRAM 2002000000 00000005000000000000 28 2 ER ERE EORR 28 ABNORMAL CELE EOCATIONS 53 ettet ee eres eroe e E dec te EX e 30 CALCULATING 8 1 2 4 000 0 000000000 32 RBC PLATELET METHOD cisccccssssesssenssseeseoseasssonsconnsssesssonsinnsasesseeessassecvesensesnntestoes 37 CYTOCHEMICAL 5 a 37 ADVA 2120 2 120r R
3. 3 2 PROCESSING THE 5 5 2 3 5 ENDING BACH SHIP manna WARREN eI ED REG T EN a 3 10 MAINTAINING THE ANALYZER eee ee ee eee enne eene ee ette eese tn aee ea 4 1 SCHEDULE 4 2 SYSTEM WASH eicere Ne IR e 4 3 CLEANING THE CENTERING 22 0 4 3 CLEANING THE SHEAR VALVE AND ASPIRATION PATHWAYS IN THE UFC 4 7 CLEANING THE SHEAR 2 4 7 INSPECTING AND CLEANING THE SYRINGE PLUNGERS eee eene 4 10 REPLACING THE SAMPLER NEEDLES 4844 4 4 4 12 REPLACING THE SHEATH 5 44444404 4 15 REPLACING THE 50 OR 1000 uL SYRINGE 4 16 CLEANING THE AIR CIRCULATION 4446 4 19 INSPECT THE PEROX CAP VENT HOLE FOR BUILDUP 0 4 20 CLEANING THE AUTOSAMPLER ASPIRATE 4 20 TROUBLESHOOTING THE ANALY ZER ee ee ee eee eee eee eo nest 5 1 ALIGNMENTS AND ADJUSTMENTS eese 5 2 CLEANING PROCEDURES 5 5 REPAIR AND REPLACEMENT 202 5 24 TROUBLESHOOTING TIPS 8 5 5 45 lg
4. 19 INSPECT THE PEROX CAP VENT HOLE FOR BUILDUP eee 19 CLEANING THE AUTOSAMPLER ASPIRATE _ 20 Maintaining the Analyzer 4 1 Schedule 4 2 To maintain the operating efficiency of your analyzer you must perform specific procedures according to the frequency listed below After 1000 samples or daily e Perform a system wash Perform the system wash procedure at the end of each shift or work period a maximum of eight hours After the laboratory shift with the largest number of samples run three system wash cycles after other shifts you need to run only one wash cycle In addition if the number of samples in a shift exceeds 400 perform one system wash after the 400th sample After 2000 samples or weekly and before recalibration e Perform an RBC baso retic flowcell wash e Clean shear valve and aspiration pathways in the UFC e Inspect the centering collars Clean if necessary e Turn off the system e Clean the shear valve After 16 000 samples or every two months e Inspect the syringes and plungers PN 067 B506 01 and PN 067 B506 02 Clean if necessary e Replace the 50 syringe plungers PN 067 B506 01 e Inspect the Perox cap vent hole for buildup Clean if necessary Every 6 months e Replace the 1000 uL syringe plungers PN 067 B506 02 e Clean the air circulation filter e Replace the autosampler needle and or the manual s
5. en 67 en 79 19 n e 87 Status Line messages 7 1 7 2 4 e 93 e 94 96 98 99 09 4 9 Status Line messages Disk Space Used Alarm Disk space used has risen to the level specified as an alarm criterion indicating available disk space is low Corrective Action Increase available disk space by deleting data from any of these files e Raw Data files e Export files e Sample Results use Customize System Setup Tools Modify End of Day e Logs Message Log Service Log User Notepad Reagent Log Workload Log IMPORTANT Deleting files permanently erases data If you need an electronic copy of the data back up or export the files before deleting Disk Space Used Stop Disk space used has risen to the level specified as the stop criterion and the autosampler has halted If stop alarm criteria are not configured the default level value is set to 98 Corrective Action Increase available disk space by deleting data from any of these files
6. RETIC CHg CHr CHCMg CHCMr CHDWeg CHDWr MCVg MCVr RDWg RDWr Corrective Action The following list may not contain all conditions that could cause this flag nor is there any intention to associate the flag with specific diagnoses e Transfusion e Sickle cell anemia e Excessive NRBCs Retic Irregular Flow Rate RTCIFR CR Definition The Retic Irregular Flow Rate flag is triggered if the cell counting rate is erratic due to a hydraulic disturbance in the retic channel Retic flow rate is evaluated in terms of the cell counting rate Sum of the Squared Differences Flow Uniformity 9 x Mean Cell Counting Rate The flag is triggered if this value is greater than 3 2 The Retic Rate histogram displays the arrival rate of cells in the retic channel Normal Retic Rate Histogram Rate Histogram mm Results Flagged RETIC RETIC Corrective Action 1 Check retic reagents 2 Check laser sample delivery 3 Check retic hydraulics 6 45 6 46 4 Check sheath delivery 5 Check the pressure and vacuum readings A partially clogged RBC baso retic sheath filter can produce a distinctive ski slope effect on the RBC Baso and Retic flow rate histograms Replace the sheath filter RBC Rate Baso Rate Retic Rate Retic Noise Origin RTC NO NO Definition The Retic Noise Origin flag is triggered if more than 10 of the gated cell signals come from the Noise Or
7. NOTE NRBC results are available only for samples processed in CBC Diff or CBC Diff Retic mode PEROX Cytogram BASO Cytogram with location of nRBC and Unstained with location of nRBC line The method identifies nRBCs by nuclear size in the Peroxidase channel and by nuclear density in the Basophil Lobularity channel In the unstained region of the Peroxidase Channel cytogram nRBC nuclei are located between the noise and lymphocytes They often form distinct populations which are analyzed to produce counts In the Basophil Lobularity channel cytogram nRBC nuclei are located in the polymorphonuclear region rather than in the mononuclear region because they are denser than lymphocyte or monocyte nuclei Since they are not the nuclei of polymorphonuclear cells the difference between the number of nuclei in this region and the sum of neutrophils and eosinophils in the Peroxidase Channel may equal the NRBC count This difference is called the Barox Baso Perox count Methods The method generates four NRBC counts for every sample Histo count The NRBC count from analysis of the unstained region of the Peroxidase Channel Y axis histogram Gaussian count The NRBC count from making a gaussian fit to the nRBC section of the unstained region of the Peroxidase Channel Y axis Residual count The NRBC count from subtracting the noise and lymphocytes from the unstained region of the Peroxidase Channel Y axis histogram
8. 6 1 MORPHOLOGY 5 000000 000 6 3 SAMPLE S YSTEM TRIN IM 6 21 STATUS LINE MESSAGES sii ccscscsssescsecescsssecisosssecdssestessocbecesesssesscescsoossaessssvsbesssessees 7 1 17104 85 0 3 8 1 BASOPHIL LOBULARITY 0 8 3 eise 8 16 HEMOGLOBIN 8 21 8 25 RBC PLATELET 2 2 000000000000000000000000000000000 8 37 RETICULOCYTE METHOD unina eere tree eer Ee ede peek e Cie ra e RR ERE ee o ye Ee ee erue 8 58 REGULATORY INFORMATION esee ee ee ee en eee eost 9 1 METHODS INTRODUCTION 9 4 CLSI DOCUMENT M29 A3 AND SIEMENS METHOD TOPICS CROSS REFERENCE 9 18 CBC METHOD 255 ERE Pe 9 21 CSE METHOD eerte 9 33 WBC DIEF MBETHODBD erre ricorrere ore etre edet eee regne 9 45 RETICULOCYTE METHOD e Ra eee e 9 54 METHOD DATA SUMMARY cccccccccccssssssececececsessaececececsessnaececececsessaaeaecececeessasaeeeeeees 9 62 ADV
9. e LO WASHING THE SYSTEM cccccecececececececececevevevevevececevevececececevevevevececscecececececevecececevevevess 10 PERFORMING THE END OF DAY PROCEDURE ssssssssesessseseesssessssssssssesesesessseseseneeeees 10 goren neto meten ee a ie ae aie aea amate 11 Daily Routine 3 1 Starting Each Shift Emptying the Waste Container BIOHAZARD WARNING All products or objects that come in contact with human or animal body fluids should be handled before and after cleaning as if capable of transmitting infectious diseases Wear facial protection gloves and protective clothing The operator should follow the recommendations to prevent the transmission of infectious agents in health care settings as recommended by the Clinical and Laboratory Standards Institute formerly NCCLS in Protection of Laboratory Workers from Occupationally Acquired Infections Approved Guideline Third Edition 2005 CLSI Document M29 A3 This document contains complete information on user protection and it can be used as reference material for instructions on laboratory safety conservation by regulating the disposal of hazardous wastes Because some of the wastes generated by the analyzer may be classified as hazardous waste you must be familiar with the applicable hazardous waste handling and disposal laws and regulations in your area WARNING Local laws and regulations protect the environment and encourage resource
10. WBCP agree within specified limits No WBC CE flag EOS is between 0 and 7 5 Flags Flags Results Flagged WBC WBCB BASO BASO LYMPH LYMPH A four part WBC differential basophils excluded is reported with the measured BASO values displayed and flagged and with the LYMPH and LUC values also flagged Corrective Action 1 Check the baso reaction chamber temperature 2 Check the reaction chamber temperature controller including the electrical connection Comparison Error MCHC CHCM CHCMCE CC Definition The Comparison Error MCHC CHCM flag is triggered if the difference between the MCHC and CHCM values is greater than 1 9 Results Flagged MCHC CHCM RBC MCV HGB HCT MCH RDW HDW CH CHDW Corrective Action Multiple occurrences of this flag especially for consecutive samples can indicate a system problem However isolated instances of this flag are usually sample related The following list of sample related causes may not contain all conditions that could cause this flag There is no intention to associate the flag with specific diagnoses System Related Sample Related 1 If another flag appears along with the e Lipemia comparison error troubleshoot that error first e Leukemia 2 To determine the faulty channel run the same high WBC normal whole blood sample five times to check precision of the RBC MCV and HGB e Neonatal NRBCs values Then run a normal
11. 10 42 AUTOSLIDE SPECIFICATIONS 480000 0 610000000000000000000008888 10 47 LEGAL INFORMATION sessisonssesssssnsssessesssssesesssonssestecvesesseasssensssnasessnassacdecsesesaasesserss A 1 LIMITED INSTRUMENT WARRANTY AND SERVICE DELIVERY POLICY A 2 WARRANTY AND SERVICE EXCLUSIONS c cccccccecssssseeecececsesssaececececeessaeceeeceesensasaeeecs A 4 CONTACT INFORMATION soa R E Ueasseseseueciegevcsusasseeeesceesesusde A 5 SIEMENS AUTHORIZED REPRESENTATIVE 1000 5 WARNINGS AND SAFETY INFORMATION 01 B 1 WARNINGS SERT P B 2 SAFETY INFORMATION ve e PEOR B 3 REGULATORY COMPLIANCE eene eren B 3 DOCUMENTATION ect e eii bee a te ar eec E ee B 4 SYSTEM SYMBOLS oii etii estt terere esed terrere eee Reese tee B 4 INTERPRETATION OF RESULTS cssessscececeesessaececececsesseaececececsensaaeaecececeeseeaeseeeeeenes B 9 EXPLANATION OF THE WARNING LABELS ON THE AC POWER BOX B 10 EXPLANATION OF THE WARNING LABELS ON THE MANUAL CLOSED TUBE 2 B 11 PROTECTING YOURSELF FROM 5 5 B 12 Contents Contents Contents Welcome to the ADVIA 2120 2120 Hematology Sys
12. Corrective Action Call Siemens Service for assistance Autosampler Input Queue Jammed Possible Cause Corrective Action 1 Rack has Remove and reset rack jammed the leading edge of input queue blade 2 Queue pan Check for foreign objects in input queue pan motion is impeded 3 Feed motor Call Siemens Service for assistance failed Autosampler Input Queue Motion Denied To prevent the collision of autosampler components the system did not execute the command to move the autosampler input queue Autosampler Input Queue Motion Denied Reset Autosampler The autosampler attempted an inappropriate input queue motion An autosampler reset is required Status Line messages 7 23 7 24 Corrective Action 1 Select Off at the analyzer touchpad 2 Wait about 1 minute and select On to restart the analyzer 3 If the problem persists call Siemens Service for assistance Autosampler Input Queue Motion Failed The autosampler input queue failed to move properly Possible Cause Corrective Action 1 Rack has a Remove and replace rack Paan n b Select Start at the analyzer touchpad The autosampler leading edge of the input resumes operation queue blade 2 Queue pan Check the queue pan for foreign objects cannot move properly 3 Feed motor Call Siemens Service for assistance has failed Autosampler Input Queue Motion Failed Reset Autosampler The autosampler input queue failed to move properly
13. Verify that a work order has been created at the host computer or at the Data Manager A work order has not been transmitted for Check if problem exists at the host computer If problem is not at the host level call Siemens Service for assistance the current patient sample No Workorder Stop No workorder received for current patient sample The number of consecutive occurrences of this condition has met the criterion specified for a stop message The autosampler has stopped Possible Cause Corrective Action 1 work order Verify that a work order has been created at the host Status Line messages has not been created for the current patient sample A work order has not been transmitted for the current patient sample computer or at the Data Manager Check if problem exists at the host computer If problem is not at the host level call Siemens Service for assistance 7 63 7 64 No Working Buffer Initialized This error can occur during the system preparation initialization process Corrective Action Restart the ADVIA 2120 21201 software If the error recurs call Siemens Service for assistance Noise BASO Alarm The number of consecutive occurrences of this condition has met the criterion specified for an alarm message The specified alarm criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Alarm Criteria is automatically
14. and or color highlighting Whenever a flag is triggered the user should review the results and take appropriate action Regulatory Information Limitations of the Procedure The limitations of the procedure are as listed 1 Some irreversibly sickled cells that occur in cases of sickle cell anemia may not completely sphere in the system resulting in an elevated RDW and therefore an underestimation of the MCV Sickled cells may cause erroneous results in other RBC parameters 2 Very high WBC counts 2200 x 10 cells uL elevate the red blood cell count 3 Samples with cold agglutinins may falsely lower the red blood cell count 4 Samples with high WBC counts gt 60 x 10 cells uL or platelet clumps and neonatal samples may interfere with the hemoglobin determination 5 Samples with extreme lipemia chylomicrons or extremely high bilirubin might interfere with and elevate the hemoglobin results obtained from the hemoglobin method including the MCHC Since these interferences do not affect the cell by cell hemoglobin concentration values obtained from the RBC method the CHCM values are unaffected If the MCHC and CHCM differ by more than 1 9 g dL a Comparison Error system flag alerts the operator to this condition 6 Patient specimens with nucleated RBCs particularly neonate specimens may falsely elevate the WBC count When manually correcting the WBC count for the presence of NRBCs use the WBCB count 7 Sample
15. Laws and regulations enacted to protect the environment and to encourage resource conservation require the disposal of hazardous and biohazardous wastes in a specified manner Some of the wastes from the ADVIA 2120 2120i Hematology System can be classified as hazardous or biohazardous wastes It is essential that the laboratory take appropriate steps to determine the laws and regulations applicable to their disposal and to effect compliance If it is necessary to sample instrument effluent in order to evaluate compliance with applicable regulations the laboratory should contact a local licensed biohazardous waste disposal firm for assistance The principal wastes associated with the use of the ADVIA 2120 2120i Hematology system are reagent containers sample containers system waste and customer replaceable system components All ADVIA 2120 2120i reagent containers are manufactured of recyclable high density polyethylene Sample containers with human specimens control materials and all reagents should also be handled and disposed of in accordance with the prevailing regulations and guidelines of agencies with jurisdiction over the laboratory Refer to the product label and to Material Safety Data Sheets for details concerning any special precautions related to the handling of reagents Material Safety Data Sheets are available from Siemens Waste Analysis After running the prescribed daily wash procedure and emptying the waste container
16. Product Symbol Number T03 3686 54 conTrot Low T03 3686 01 CONTROL LOW Contents Amount mL Hematology Control 4x4 0mL Low Hematology Control 4 0 mL Low ADVIA 120 TESTpoint Hematology Control Normal Product Symbol Contents Amount Number mL T03 3687 54 Hematology Control 4x 4 0 mL Normal T03 3687 01 Hematology Control 4 0 mL Normal ADVIA 120 SETpoint Hematology Calibrator Product Symbol Contents Amount Number mL T03 3685 52 cat Hematology 2x 6 1 mL Calibrator Regulatory Information REF REF 04408568 Product Symbol Contents Amount Number mL T03 3685 01 Hematology 6 1 mL Calibrator ADVIA 120 Product Contents Amount mL Number 03 3682 54 OPTIpoint 4x 6 0 mL 03 3682 01 OPTIpoint 6 0 mL NOTE Control products for the CSF Method and the Reticulocyte method are described in those sections Calibrator and Control Value Assignment Methods All assigned target values for ADVIA SETpoint Hematology Calibrator and ADVIA TESTpoint Hematology Controls are traceable to NIST ICSH or NCCLS recommended procedures or approved reference procedures and materials The reference Red Blood Cell RBC and White Blood Cell WBC counts are performed using the recommended method with a single channel aperture impedance counter Macro dilutions of 1 500 for WBC and 1 50 000 for RBC are made using Class A glassware The reference Platelet Count Plt is performed
17. The number of consecutive occurrences of this condition has met the criterion specified for a stop message The autosampler halts at the same time the stop message occurs The specified stop criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Stop Criteria is reset when the Start Stop button is selected RETIC Saturation Cells Alarm The number of consecutive occurrences of this condition has met the criterion specified for an alarm message The specified alarm criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Alarm Criteria is automatically reset RETIC Saturation Cells Stop The number of consecutive occurrences of this condition has met the criterion specified for a stop message The autosampler halts at the same time the stop message occurs The specified stop criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Stop Criteria is reset when the Start Stop button is selected RETIC Slope Error Alarm The number of consecutive occurrences of this condition has met the criterion specified for an alarm message The specified alarm criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Alarm Criteria is automatically reset RETIC Slope Error Stop The number of consecutive oc
18. 2 Disconnect and discard the filter 3 Install the new filter IMPORTANT The direction of the filter is important Look for the words FLUID SIDE on the filters and orient the filters in the lines as shown in the figure above 4 Discard the paper towels 5 Turn the analyzer power on AN CAUTION To avoid serious damage to the analyzer you must never turn on the analyzer without the vacushield filter in place Troubleshooting the Analyzer 6 For the manual waste removal at the Utilities menu select the Analyzer Status tab At the Vacuum and Pressure area check that the 20 in Hg reading is between 19 and 21 If required adjust the 20 in Hg vacuum regulator knob IMPORTANT All pneumatic settings must be reached by turning the knobs in an upward or clockwise direction only If a reading goes above the target value turn the knob back and allow the analyzer to equilibrate The analyzer displays a new reading every five seconds Adjust upward to the correct value For systems with automatic waste removal also verify the 20 psi reading If necessary adjust the pressure regulator knob 7 Ifa 19 to 21 reading cannot be reached check that the lines to the filter are secure If you are still having difficulty call Siemens technical support Replacing the wash block Time Replacement 5 minutes Checkout 15 minutes Analyzer mode Standby BIOHAZARD All products or objects that come in contact with human or a
19. 3 Pressure or vacuum levels are out of range Empty the waste container a b Verify that the vacuum and pressure readings are within range Adjust as necessary After about 1 minute if the status line does not display Ready to Run and the green ready to aspirate light is still off follow these steps to exit the ADVIA 2120 21201 software turn off the analyzer and then restart Select Shut Down ADVIA at the Log On Off window ii Select Off at the analyzer touchpad iii Select CTRL ALT DELETE and log back onto the system to restart the software iv Restart the analyzer by selecting On at the analyzer touchpad Analyzer Reset Required A critical system failure has occurred and an analyzer reset is required Possible Cause Potential hardware failure associated with at least one of these components Motor node pressure node parallel node switch indicator or selector valve Corrective Action 1 2 Reset the analyzer by selecting Utilities Exerciser Indicators Analyzer Reset After about 1 minute if the status line does not display Ready to Run and the green ready to aspirate light is still off follow these steps to exit the ADVIA 2120 21201 software turn off the analyzer and then restart a Select Shut Down ADVIA at the Log On Off window b Select Off on the analyzer touchpad Select CTRL ALT DELETE and log back onto the system to restart the software d Restart the anal
20. DIFF TIMEPAC Product Number T01 3621 52 T01 3630 01 T01 3631 01 T01 3632 01 T01 3633 01 ADVIA 120 BASO Product Number T01 3629 01 ADVIA 120 SHEATH RINSE Product Number T01 3664 01 T01 3623 01 ADVIA 120 PEROX 1 Contents DIFF TIMEPAC PEROX 1 PEROX 2 PEROX 3 PEROX SHEATH Contents BASO Contents SHEATH RINSE SHEATH RINSE Prod No T01 3630 01 2 x 650 mL ADVIA 120 PEROX 1 contains Sodium dodecyl sulfate 0 36 mmol L Sorbitol 620 mmol L Sodium chloride 8 35 mmol L Formaldehyde 5 7 BRIJ 35 0 100 mmol L Buffer Regulatory Information Amount mL 2 x 650 mL 2 x 305 mL 2x 585 mL 2 x 2725 mL Amount mL 2x 1100 mL Amount L 101 201 9 47 x HARMFUL R20 21 22 R36 37 38 R40 R43 Contains formaldehyde Potential cancer hazard Harmful by inhalation 526 836 37 s45 s51 contact with skin and if swallowed Irritating to eyes respiratory system and skin Possible risk of irreversible effects May cause sensitization by skin contact In case of contact with eyes rinse immediately with plenty of water and seek medical advice Wear suitable protective clothing and gloves In case of accident or if you feel unwell seek medical advice immediately show label where possible Use only in well ventilated areas For in vitro diagnostic use ADVIA 120 PEROX 2 PN T01 3631 01 2 x 305 mL ADVIA 120 PEROX 2 contains 4 Chloro 1 naphthol 44 8 mmol L Diet
21. EOS LUC and LUC Corrective Action 1 Check perox reagents 2 Check perox hydraulics and sample delivery 3 Check sheath delivery 4 Check the pressure and vacuum readings Perox No Valley PX NV VX Definition The Perox No Valley flag is triggered if there is no valid separation between the noise and lymphocyte populations in the Perox cytogram The separation of the noise and lymphocyte populations along the y axis of the Perox cytogram is evaluated by the relative depth of the valley PEROX d D between the two populations In normal samples PEROX d D is greater than 0 15 This flag is triggered if is less than 0 15 Normal PX NV VX Flag Noise peak 2 Lymph peak Noise Lymph Noise Lymph nm PX NV flag is not triggered if agreement between the baso results is indicated by both the following conditions Flags 6 35 e WBCB and WBCP agree within specified limits No WBC CE flag NEUT EOS PMN is between 0 and 7 5 Results Flagged WBCP NEUT NEUT LYMPH LYMPH MONO EOS EOS LUC and LUC Corrective Action Multiple occurrences of this flag especially for consecutive samples can indicate a system problem However isolated instances of this flag are usually sample related The following list of sample related causes may not contain all conditions that could cause this flag There is no intention to assoc
22. Optional Use the To and From date boxes to restrict listing to workorders created within a specific period of time Optional Choose a report format from the Format list DEFAULT is usually sufficient Select Display to view the list or select Print to print it Running the Samples Control Recommendations Run controls in accordance with your laboratory protocol Run multilevel controls at the beginning of each shift Siemens recommends the use of ADVIA TESTpoint Hematology Controls Low Normal and High and ADVIA TESTpoint Reticulocyte Control Low and High Run controls alone or at the start of the patient workload Optionally you can run a retained patient sample periodically to monitor performance trends Evaluate all control results before reporting patient results If control results fail to meet the laboratory s established criteria for acceptability you must evaluate all patient test results obtained in the unacceptable run to determine if the patient results were adversely affected Perform and document appropriate corrective actions which may include recalibration and reassaying of patient samples before reporting patient results Daily Routine To run samples from the autosampler 1 Load samples in the following order e Whole blood primer primer label e Controls control label e Patient samples sample ID label a Insert tube into rack with the barcode label visible above the rack barcod
23. Using the Mie theory of light scattering for homogeneous spheres the low angle high gain light scatter measurement is converted into cell volume and the high angle high gain light scatter measurement is converted into refractive index n The following histograms and cytograms are used for platelet analysis Platelet X histogram is formed from the high angle 5 to 15 high gain light scatter signals Platelet Y histogram is formed from the low angle 2 to 3 high gain light scatter signals Platelet Vol histogram shows the distribution of platelets by cell volume Platelet PM histogram shows the distribution of platelets by dry mass Platelet PC histogram shows the distribution of platelets by refractive index PLT Scatter cytogram is formed by plotting the high angle 5 to 15 high gain light scatter signals along the x axis and the low angle 2 to 3 high gain light scatter signals on the y axis PLT Volume PC cytogram is formed by plotting the refractive index of platelets PC along the x axis and the platelet volume on the y axis Bibliography Tycko DH Metz MH Epstein EA Grinbaum Flow cytometric light scattering measurement of red blood cell volume and hemoglobin concentration Applied Optics 24 9 1355 1365 1985 8 39 8 40 RBC Rate Histogram The RBC Rate histogram shows the uniformity of the cell counting rate The rate histogram data consists of 50 points one taken every 200 milli
24. b Wait about 1 minute and select On to restart the analyzer c Ifthe problem persists call Siemens Service for 7 35 assistance 2 Persistent AN CAUTION mixer problem causing Call Siemens Service for assistance Only Siemens binding and Service personnel are authorized to take this corrective excessive drag action on the racks a Using the Autosampler window of the Exerciser tab move the mixer to the Home position b Manually move a rack from the input shuttle through the mixer to the output shuttle Check for binding and excessive drag when moving the rack c Perform the mixer alignment procedure as necessary Autosampler Rack or Position Barcode Not Read The barcode reader cannot determine a valid rack ID or position number for the current tube position Possible Cause Corrective Action 1 Rack barcode Make sure the barcode label is correctly placed on the label rack is clean and meets specifications improperly placed obscured or absent 2 Window of a Clean barcode reader window barcode reader is dirty or line of sight is obstructed c If problem persists call Siemens Service for assistance b Make sure there is no visual obstruction between the barcode reader window and the rack 3 Faulty barcode Siemens Service for assistance reader Autosampler Rack Scan Denied Barcode reader is unable to scan Possible Cause Corrective Action 1 Faulty barcode At the analyzer tou
25. e Raw Data files e Export files e Sample Results use Customize System Setup Tools Modify End of Day e Logs Message Log Service Log User Notepad Reagent Log Workload Log IMPORTANT Deleting files permanently erases data If you need an electronic copy of the data back up or export the files before deleting 20 PSI Out of Range System pressure is out of range Status Line messages 7 3 7 4 Possible Cause Corrective Action 1 PSI pressure Check the 20 PSI gauge and adjust the regulator if gauge is outof necessary range Setpoint 20 PSI 1 2 Pressure leak Check for crimped or disconnected hydraulic or pneumatic lines Straighten or reconnect lines as necessary 20 PSI Out of Range Stop System pressure is out of range The system has stopped because the pressure has reached a critical level that may affect the integrity of sample results and damage the system Possible Cause Corrective Action 1 PSI pressure Check the 20 PSI gauge and adjust the regulator if gauge is outof necessary range Setpoint 20 PSI 1 2 Pressure leak Check for crimped or disconnected hydraulic or pneumatic lines Straighten or reconnect lines as necessary IMPORTANT If problems persist Call Siemens Service for assistance Further corrective action must be taken by Siemens service personnel only 4 Key Not Found The Control Dictionary or the Alarm Dictionary is empty If the Alarm Dictionary is empty sample system fl
26. 1 At the Utilities menu select Hydraulic Functions 2 Select System Wash select 1 for the Number of Cycles then select Start Cleaning the Centering Collar Clean the centering collars and bases if there is residue buildup Inspect the autosampler aspirate assembly area for salt buildup Clean if necessary Maintaining the Analyzer 4 3 4 4 BIOHAZARD All products or objects that come in contact with human or animal body fluids should be handled before and after cleaning as if capable of transmitting infectious diseases Wear facial protection gloves and protective clothing The operator should follow the recommendations to prevent the transmission of infectious agents in health care settings as recommended for potentially infectious specimens in Protection of Laboratory Workers from Infectious Disease Transmitted by Blood Body Fluids and Tissue 2d edition Approved Guideline 1997 Document M29 A National Committee for Clinical Laboratory Standards NCCLS This document contains complete information on user protection and it can be used as reference material for instructions on laboratory safety Biohazard warning WARNING Materials required e Beakers 2 The analyzer must be off otherwise ee personal injury from the needle may occur e Household bleach e Paper towels e Stylet or thin wire e Syringe e Tubing 0 020 inch ID Time 10 minutes per centering collar Analyzer mode Off To clean the centeri
27. 1 LUC area 2 BLASTS area The BLASTS value is intended for flagging and laboratory purposes only The BLASTS value is not to be reported as a patient result Results Flagged none Possible Causes The following list of sample related causes may not contain all conditions that could cause this flag Multiple occurrences of this flag especially for consecutive samples can indicate a system problem However isolated instances of this flag are usually sample related Sample Related System Related e Acute leukemias 1 Check the perox and baso reagents e Chronic leukemias Check the delivery of SHEATH RINSE e Lymphomas Check the perox hydraulics Myelofibrosis Check baso hydraulics e Refractory anemia with Check the perox flowcell alignment excess blasts RAEB Check the laser flowcell alignment e Neonatal samples Check the pressure and vacuum readings 90 CIL Qv deo qe Check the baso and perox gains 6 7 6 8 HGB Concentration Variance HCVAR Definition The Hgb Concentration Variance flag is triggered if the variation in cell hemoglobin concentration HDW is equal to or greater than 3 4 g dL The Hemoglobin Distribution Width HDW parameter is the standard deviation of the cellular hemoglobin concentration distribution on the RBC HC histogram Default trigger values for the three severity levels are HDW 3 4 g dL to 3 9 g dL HDW 4 0 g dL to 4 6 g dL HDW gt 4 6 g dL Resul
28. 2 Wait about 1 minute and select On to restart the analyzer 3 If the problem persists call Siemens Service for assistance Autosampler Invalid Operation Mode Reset Autosampler The autosampler was unable to carry out a requested motion The autosampler might not be in the correct mode Corrective Action 1 At the analyzer touchpad select Off 2 Wait about 1 minute and select On to restart the analyzer 3 If the problem persists call Siemens Service for assistance Autosampler Invalid Sequence Number The autosampler sent the analyzer a sample ID sequence number that did not match the expected sequence number Status Line messages 7 25 7 26 Possible Cause 1 The autosampler performed two index operations but no aspiration 2 The message sent from the autosampler to the analyzer did not contain the sample ID sequence number expected for the tube in the current rack position Corrective Action At the analyzer touchpad select Off b Wait about minute and select On to restart the analyzer If the problem persists call Siemens Service for assistance See la b Autosampler Mechanical Constraint To prevent the collision of autosampler components the system did not execute the requested action Autosampler Mixer Failed The autosampler mixer failed and may be defective Corrective Action 1 On the analyzer touchpad select Off 2 Wait about 1 minute and select On to r
29. 3 into the D flowcells 4 JA The sheath diaphragm 2 pumps 5 push sheath 2 L N 6 through the sheath V25 24 V15 wr filters 7 directly into the flowcells 1 The sheath pumps 8 pull the PEROX SHEATH or 8 SHEATH RINSE and the reacted sample stream 9 through the flowcells for analysis The analyzed sample and sheath are sent to waste 5 10 and the lines e flowcells and reaction DP1 V26 Ww chambers are washed and rinsed 10 10 Welcome to the ADVIA 2120 2120i Hematology System 1 11 1 12 Reagents SHEATH RINSE Wash and DEFOAMER Reagent is mixed with a sample for cytochemical analysis and measurement Sheath is a fluid that envelops the sample stream as it passes through the optics ensuring cell by cell analysis Rinse cleans the hydraulic pathways and reaction chambers after each sample to prevent carryover and ensure the integrity of the results Wash solution removes buildup in the hydraulic pathways A system wash should be performed periodically once a day or after a set number of samples DEFOAMER reduces foam buildup in the waste container Wash PEROX SHEATH DEFOAMER and all cytochemical reagents are located on the analyzer and except for the SHEATH RINSE and DEFOAMER they are monitored o
30. Alarm Stop Criteria The counter associated with the Alarm Criteria is automatically reset BASO Count Suspect Stop The number of consecutive occurrences of this condition has met the criterion specified for a stop message The autosampler halts at the same time the stop message occurs The specified stop criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Stop Criteria is reset when the Start Stop button is selected BASO Irregular Flow Rate Alarm The number of consecutive occurrences of this condition has met the criterion specified for an alarm message The specified alarm criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Alarm Criteria is automatically reset BASO Irregular Flow Rate Stop The number of consecutive occurrences of this condition has met the criterion specified for a stop message The specified stop criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Stop Criteria is reset when the Start Stop button is selected BASO Reagent Empty Stop The number of consecutive occurrences of this condition has met the criterion specified for a stop message The reagent is empty and the autosampler has halted The specified alarm criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria Reagent Conditio
31. Barox count The NRBC count from the equation nRBC PMNs NEUTs EOS The system then uses selection rules to determine which if any of the NRBC counts to report NRBC Enumeration Histogram The NRBC Enumeration Histogram is a Legend 100 channel display of the light scatter measurements and corresponds to the unstained region of the Peroxidase Channel Residual Y axis histogram This display of the Lumoh trans NRBC Analysis shows overlays of e Unstained Events e PLT Events NRBC Gauss Fit e NRBC Residual e Lymph Events The histogram also includes goalposts which designate the Histo and Residual NRBC Enumeration Histogram counts These goalposts appear only when the Histo or Residual count is the selected NRBC count Calculating Reported NRBC Parameters The system corrects the reported WBC count when nRBCs are detected Histo Residual or WBCu Gaussian Count NRBC 100 Barox Count wcp Wace Methods 8 57 Reticulocyte Method 8 58 Cytochemical Reactions The reticulocyte cytochemical reactions consist of two steps Step 1 RBCs and platelets are isovolumetrically sphered using ADVIA 2120 2120 autoRETIC reagent Step 2 Reticulocytes are differentially stained based on their RNA content ADVIA 2120 2120 autoRETIC NOTE For more detailed information on the contents of ADVIA 2120 21201 autoRETIC reagent please see Chapter 8 The ADVIA 2120 2120i autoRE
32. Comparison Error MCHC CHCM Stop The number of consecutive occurrences of this condition has met the criterion specified for a stop message The autosampler halts at the same time the stop message occurs The specified stop criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Stop Criteria is reset when the Start Stop button is selected Comparison Error WBCB WBCP Alarm The number of consecutive occurrences of this condition has met the criterion specified for an alarm message The specified alarm criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Alarm Criteria is automatically reset Comparison Error WBCB WBCP Stop The number of consecutive occurrences of this condition has met the criterion specified for a stop message The autosampler halts at the same time the stop message occurs The specified stop criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Stop Criteria is reset when the Start Stop button is selected Status Line messages Compressor Timeout During system startup or when exiting standby the compressor has failed to reach the acceptable pressure or vacuum levels within the allotted time Possible Cause Corrective Action 1 System Manually vent the waste restarted too container by quickly after disconnecting the wast
33. Dispensing methanol DN4 11 Slide removal Needle Position Action DNI Undil Stain 1 32 1 DN2 Buffer 22 0 DN3 Dil Stain 2 8 1 DN4 Methanol 31 0 DN7 Rinse 24 2 AN2 22 0 AN3 8 1 AN4 31 1 AN7 24 2 NOTE Needles AN2 and DN2 in position 22 are unused in this protocol Methanol Volume mL 4 Stain Volume mL 3 6 Dilution Ratio 25 Duration Long Principle of the Procedure The stained smear is examined microscopically the nucleus and the cytoplasm of neutrophils lymphocytes monocytes eosinophils and basophils show a characteristic blue or red coloration Cells are then manually differentiated and quantified Cell Type Cell Component Color Neutrophils Nuclei Vibrant deep purple Cytoplasm Pink background Granules Light purple violet Lymphocytes Nuclei Distinct deep purple Cytoplasm Sky blue to deep blue Monocytes Nuclei Light purple with distinct spaces between chromatin strands Cytoplasm Dull blue gray with lightly stained Granules Fine pink to violet and evenly distributed Eosinophils Nuclei Pale purplish blue and well defined ADVIA Autoslide Slide Maker Stainer 10 33 10 34 Cell Type Cell Component Cytoplasm Granules Basophils Nuclei Cytoplasm Granules Platelets Cytoplasm Granules Red Blood Cells Biconcave disks Howell Jolly bodies Dohle bodies Cytoplasm Promyelocyte Granules Auer Rods Cytoplasm Causes of RBC Artifacts e Post stain rinsing too short e Reagents e
34. Evaluate control results or validate patient results when available Viewing the Sample Run 1 2 3 At the Data Manager menu select Sample Cont Panel Use the database status area to work with records by sample status To get a list of samples with a specific status select the status box then select File Mgt To validate results for samples with a specific status select the status box and then select Rev Edit The test panel area provides a test by test assessment of control performance and a sample listing by time of aspiration Control color coding is as follows Green Control results for test are between target and 2 SD Yellow At least one control result is between 2 SD and 3 SD or 2 SD and 3 SD m Red At least one control result is lower than 3 SD or higher than 3 SD Daily Routine Validating the Results 1 2 At the Data Manager menu select Review Edit If not already done select validation mode and access mode to determine which sample records will be reviewed Review the displayed results Scroll to view additional results You can e Goto step 5 if all results are acceptable Fdit a result a b Select C RES current result box for test Enter new value or comment code Select End to exit or Next to edit additional results You can select Individual to edit one result Successive to access all results or Pending to access only missing results e Ap
35. Other command is problem persists call Siemens processing ASL Internal software Failure Software initialization problem or Enter correct information Run a error incorrect data entered mechanical initialization cycle Call your Siemens Representative if not resolved ASL Internal Failure Autoslide internal synchronization Perform a mechanical initialization If synchronization error error problem persists call Siemens ASL Needle plate error Failure Staining needle positioning Open the covers and identify the problem problem Close covers Refer to Tips 2 amp 3 If needles hitting slides call Siemens ASL Operation Failure Run Stopped Autoslide Check Message Log Detail screen for completed in error command completed with an error cause correct and perform Mechanical Initialization ASL Printer error Failure Printer ribbon not advancing or Open front panel inspect printer ribbon jammed clear jam or replace ribbon as needed Ensure that there are no glass particles in the printer area Runa Mechanical Initialization cycle Cycle autoslide power if necessary ASL Rack Error Stop Failure General rack problem could be Replenish racks in dispenser check for low on racks jammed rack or full ejection tray Run a reset smearer See Tips above ASL Rack Handling Failure Hardware failure in rack handler Check for jammed racks or debris Run error track a reset smearer See Tips above ASL Slide Carrier error Failu
36. Sample identification and the type of test requested is entered by the manual barcode reader or from the Manual Sample ID tab before starting sample aspiration Unified Fluids Circuit UFC The UFC assembly uses Unifluidics technology The UFC block is made up of eight acrylic plates Machined within these plates are the pathways for the fluids and air flow valves and four reaction chambers The perox reaction chamber is mounted on the outside surface of the UFC block The reagent pump assembly mounted to the bottom of the UFC block is also acrylic The pump has one membrane with seven individual pump areas that act as diaphragms that force the reagents into the reaction chambers A 1 Hgb Reaction Chamber Not Visible Retic Reaction Chamber 5 Perox Reaction Chamber Welcome to the ADVIA 2120 2120i Hematology System 1 5 2 Baso Reaction Chamber 6 Shear Valve 3 RBC Reaction Chamber 7 Reagent Pump Assembly Shear valve The shear valve 1 is made up of two ceramic disks The rear disk 2 is stationary The front disk 3 rotates P to shear or divide the sample into appropriate aliquots for analysis The front disk also rotates to allow aspiration for direct cytometry side view of the UFC Reaction chambers The reaction chambers are machined pockets in the urc assembly where the sample and
37. The limited warranty period generally commences upon installation of the original instrument at the customer s location and extends for a period of 1 year thereafter unless otherwise specifically agreed to by and between Siemens or its authorized distributors and customer in a writing signed by duly authorized representatives of both parties sales representatives are generally not authorized representatives of Siemens for these purposes Additional Service Period The customers with some exceptions may purchase additional service coverage beyond any initial warranty period as part of the original instrument acquisition for second or subsequent years beyond the original installation date The customer s original Purchase Invoice or appropriate Agreement Addendum must indicate the term in months for additional service coverage Legal Information Legal Information Service During Normal Hours The customer may obtain service for instruments during normal business hours by contacting the nearest Siemens location or authorized distributor Refer to the list of Siemens locations in this section Extent of a Service Call Warranty or service calls generally include onsite repair or exchange of instruments or components travel to the location of the instrument and onsite labor during normal business hours A warranty or service call is initiated by the customer by following the instructions on how to obtain service for the customer s in
38. Wait about 1 minute and select On to restart the analyzer If the problem persists call Siemens Service for assistance AN CAUTION Call Siemens Service for assistance Only Siemens Service personnel are authorized to take these corrective actions a b Using the Autosampler window of the Exerciser tab move the mixer to the Home position Manually move a rack from the input shuttle through the mixer to the output shuttle Check for binding and excessive drag when moving the rack Perform the mixer alignment procedure as necessary Autosampler Car Motion Denied To prevent the collision of autosampler components the system did not execute the command to move the autosampler car Autosampler Car Motion Denied Reset Autosampler The autosampler attempted an inappropriate car motion An autosampler reset is required Corrective Action 1 Select Off at the analyzer touchpad 2 Wait about 1 minute and select On to restart the analyzer 3 Ifthe problem persists call Siemens Service for assistance Autosampler Car Motion Failed Reset Autosampler The autosampler car has failed to move properly A reset is required Corrective Action 1 Open the autosampler access door 2 Close the autosampler access door The autosampler resets Status Line messages 7 17 3 If the problem persists select Off ay the analyzer touchpad 4 Wait about 1 minute and select On to restart the analyzer 5 If the p
39. 0 5 RDW 72h 72h 12 to 15 123 0 07 0 6 0 86x 1 3 0 980 0 6 HDW g dL 72h 72h 1 9 to 3 0 2 56 0 02 0 8 0 98x 0 06 0 959 0 13 PLT 10 48h 48h 140 to 360 256 6 9 2 7 1 08x 2 0 0 991 27 0 1 5 to 208 10 x 107 pL 205 to 3983 4 9 96 MPV fL 8h 8h 7109 8 1 0 11 1 4 0 76x 0 9 0 925 0 4 Hct 96 33 to 57 n a MCH pg n a n a 24 to 31 n a n a n a n a n a n a MCHC g dL 281034 n a n a n a not available or not applicable for this parameter x Technicon He3 RTC System y ADVIA 120 Hematology System Regulatory information 9 63 WBC DIFF Method Data The sample stability expected ranges and performance characteristics for the WBC DIFF method are listed in the following Table NEUT LYMPH MONO EOS BASO LUC 9 64 Sample Stability Room Temp 36h 36h 72h 8h 72h 72h Refrigerated 72h 72h 72h 72h 56h 72h Expected Values 40 to 77 16 to 44 4to9 1to7 0101 1104 55 0 31 3 7 2 3 4 0 5 2 5 SD 0 9 0 9 0 5 0 3 0 1 0 4 CV 1 6 2 9 6 9 8 8 20 0 16 0 Correlation Data y 1 02x 0 6 1 00x 0 8 0 85x 0 3 0 87x 0 2 0 67x 0 0 0 92x 0 6 0 997 0 997 0 943 0 979 0 772 0 994 Sy x 1 6 1 7 0 8 0 4 0 2 0 7 Regulatory Information RETIC Method Data The sample stability expected ranges and performance characteristics for the RETIC method are liste
40. 0 pg PLT Scatter Cytogram The PLT Scatter cytogram is the graphical representation of two light scatter measurements the high angle 5 to 15 high gain light scatter is plotted on the x axis A and the low angle 2 to 3 high gain light scatter is plotted on the y axis B Platelets Large platelets Red blood cells RBC fragments RBC ghosts a WN Using the Mie theory of light scattering for homogeneous spheres the low angle and high angle light scatter signals for each cell are transformed into volume and refractive index n values 8 47 8 48 The PLT map shows the relationship between the light scatter measurements and the cell by cell characteristics of volume and refractive index The map grid encompasses volumes between 0 fL and 30 fL and refractive index between 1 3500 and 1 4000 The platelet count includes platelets 1 and large platelets 2 RBC fragments 4 and RBC ghosts 5 are not included in the platelet count but are enumerated for flagging purposes Due to the high gain used in the platelet method the RBCs appear in the saturation channels at the upper right corner of the cytogram PLT Volume PC Cytogram Displayed cells 1 Platelets 2 Red blood cells The Platelet Volume Refractive Index PC cytogram is a 100 by 100 channel display x axis A refractive index concentration of the platelet component PC range 0 g dL to 40 g dL y axis B platelet v
41. 1 03 2 52 halide mg dL of Cl DMF 269 DMF was calculated by Siemens based on the dilution of the autoRETIC reagent in the system waste Volatile Organic Compounds in System Waste Concentrations are ug L ppb unless otherwise noted lt indicates that the concentration is below the limit of detection Determinand CBC CBC Diff CBC Diff Retic Dichloromethane lt 25 lt 25 lt 25 Regulatory Information 9 11 9 12 Determinand Chloroform 1 1 1 Trichloroethane Carbon tetrachloride Benzene 1 2 Dichloroethane Trichloroethene Bromodichloromethane Dibromochloromethane 1 1 2 2 Tetrachloroethane Toluene Freon 113 Tetrachloroethene Chlorobenzene Ethylbenzene m p Xylenes o Xylene Hexachlorobutadiene 4 Chlorotoluene 2 Chlorotoluene Isopropyl benzene Bromoform Styrene 1 3 5 Trichlorobenzene 1 2 3 Trichlorobenzene 1 2 4 Trichlorobenzene 1 2 Dichlorobenzene 1 3 Dichlorobenzene 1 4 Dichlorobenzene alpha Methyl styrene CBC CBC Diff 3 lt 5 1 1 1 1 1 lt l I lt l lt l 1 15 lt l 1 1 lt l 1 lt l lt l 1 lt l 1 1 1 16 1 14 I 2 5 1 lt l 1 1 1 1 I 1 1 1 5 1 lt l 1 1 1 1 1 lt l 1 1 1 1 4 lt l 4 lt 1 CBC Diff Retic 27 lt 5 1 1 lt l 1 1 1 I lt l 1 1 3 1 1 lt l 1 1 lt l lt l lt 1 1 1 lt l 1
42. 1 Critical autosampler error 2 Mixer is blocked by a foreign object 3 Mixer home sensor is faulty 4 Mixer motor power cable is not properly Corrective Action At the analyzer touchpad select Off b Wait about 1 minute and select On to restart the analyzer c Ifthe problem persists call Siemens Service for assistance a Open the autosampler access door b Remove any foreign objects that might block mixer motion Close the autosampler access door The autosampler will reset Call Siemens Service for assistance Call Siemens Service for assistance 7 27 connected or is faulty Autosampler Mode of Operation Not Set The autosampler was unable to carry out a requested motion while the system was in the Exerciser tab Corrective Action In the Exerciser tab set the autosampler to the correct mode for the operation you want to perform You may have to reset the autosampler before proceeding To reset the autosampler 1 Atthe analyzer touchpad select Off 2 Wait about 1 minute and select On to restart the analyzer 3 If the problem persists call Siemens Service for assistance Autosampler Motion Denied Reset Autosampler The autosampler has failed to execute a command to move and must be reset Corrective Action 1 At the analyzer touchpad select Off 2 Wait about 1 minute and select On to restart the analyzer 3 If the problem persists call Siemens Service for assistance Autosa
43. 1997 Document M29 A National Committee for Clinical Laboratory Standards NCCLS This document contains complete information on user protection and it can be used as reference material for instructions on laboratory safety 1 Carefully push the wash block 1 down to its fully lowered position 2 Remove the threaded fitting 2 from the probe mount 3 by turning it counterclockwise 3 Carefully slide the probe 4 up and out of the probe mount 4 Discard the probe 5 Remove the plastic ring and spacer from the replacement probe and discard Carefully insert the probe through the opening of the probe mount 3 and into the opening of the wash block Replace the threaded fitting and finger tighten by rotating it clockwise 6 Check the length of the sample probe and adjust if necessary See page 5 3 for instructions 7 Before starting to run patient samples again check operation as follows a Run several saline primers to verify that there are no leaks then run a whole blood primer to verify that the probe is being properly washed after aspiration Troubleshooting the Analyzer 5 37 b Visually check for bubbles in the open tube sample line Run enough controls to verify analyzer performance If control results are not acceptable check that the probe has been properly installed If no problem is found recalibrate the affected channel Replacing the Perox Lamp AN WARNING To prevent injury to eyes
44. 2 1 2 1 Regulatory Information Determinand CBC CBC Diff CBC Diff Retic 1 1 Dichloroethane I I I 1 1 2 Trichloroethane I I I 1 1 Dichloroethene I I I trans 1 2 I I I Dichloroethene cis 1 2 Dichloroethene I I I Tert butyl methyl ether 1 1 1 Vinyl chloride 25 25 25 Methyl methacrylate 5 5 5 Freon 11 25 25 25 System Method Information The method information provided for the Reticulocyte Count RETIC method the Complete Blood Count CBC method and the Differential DIFF method is consistent with the recommendations described in CLSI Document M29 A3 and by the United States Food and Drug Administration in Title 21 Code of Federal Regulations A laboratory procedure manual is mandatory for good laboratory practice and regulatory compliance To aid in the preparation of a laboratory procedure manual refer to the cross reference that compares the organization of our method information with the guidelines for Clinical Laboratory Procedure Manuals formerly NCCLS in Protection of Laboratory Workers from Occupationally Acquired Infections Approved Guideline Third Edition 2005 CLSI Document M29 A3 Siemens Method information is presented in a consistent format organized into the following categories or section headings Intended Use Principles of the Procedure Reagents Storage and Stability Sample Handling Materials Required but not Provided Procedur
45. 2 areas appears approximately EOS 2 areas is much less equal to the count in the PMN than the count in the PMN area 3 area 3 Results Flagged NEUT LYMPH LYMPH MONO EOS EOS BASO BASO LUC and LUC Flags 6 15 Possible Causes The following list of sample related causes may not contain all conditions that could cause this flag Multiple occurrences of this flag especially for consecutive samples can indicate a system problem However isolated instances of this flag are usually sample related Sample Related System Related e Myeloperoxidase 1 Troubleshoot the perox channel deficiency 2 Check the perox reagents 3 Check peroxidase hydraulics 4 Check the perox reaction chamber temperature Nucleated Red Blood Cells NRBC Definition The detection of nucleated red blood cells or the occurrence of either the Suspect Cellular Interference NRCELL flag or the Suspect Large Platelets NRLPLT flag will trigger the NRBC Morphology flag There is no severity level associated with this flag Possible Causes The following list of sample related causes may not contain all conditions that could cause this flag Multiple occurrences of this flag especially for consecutive samples can indicate a system problem However isolated instances of this flag are usually sample related Sample Related System Related e Neonatal samples 1 Check perox reagents e Hemoglobinopathi
46. 31 9 in Depth 68 cm 26 8 in Depth 68 cm 26 8 in Personal Computer CPU Monitor Weight 10 6 cm 4 2 in 7 0 kg 15 43 Ibs Height 38 9 cm 15 3 in Extended in Landscape 54 6 cm 21 50 in Compressed in Portrait 38 0 cm 14 96 in Width 38 9 15 3 in 37 6 cm 14 8 in Depth 9 9 kg 22 lbs 21 3 cm 8 37 in Sample mode volumes Automatic Closed Tube 175 uL Manual Closed Tube 175 uL Manual Open Tube 175 uL Test Selectivity Throughput CBC 120 Samples hr CBC diff 120 Samples hr CBC diff retic 74 Samples hr 74 Samples hr 74 Samples hr Welcome to the ADVIA 2120 2120 Hematology System 1 25 1 26 Welcome to the ADVIA 2120 2120i Hematology System Turning the System On Off OVERVIEW i sssssscssevsiectsicaccsssacsisssesctecssbasesesssbatscsss sess scbensdesesssecsssssscsiseessecsasusescsbens vcssssbes 2 TURNING THE SYSTEM ON ssssscssssscccssssccccssscccssssccccssscccesssccccsssaccesscsscesssceccssnees 2 TURNING THE SYSTEM OP P cccsssccssssscccssssccssssccccssscccscsscccssssccsessscecesscecessnses 4 TURNING THE SYSTEM OFF IN AN EMERGENCY 4 TURNING THE SYSTEM OFF 00000 4 EXITING THE ADVIA 2120 2120I SOFTWARE 0442422222 4 Turning the System On Off 2 1 Overview The ADVIA 2120 2120i Hematology System consists of two main components the computer and the
47. 38 2 14 20 30 10 CSF RBC Count The accuracy of the CSF RBC count was evaluated by comparing manual counts from 78 CSF patient samples to counts from the ADVIA 120 Hematology System Accuracy statistics are found in the table below Manual ADVIA 120 R Slope Intercept Mean Mean Bias 0 989 1 18 19 481 551 628 77 Absolute CSF WBC Differential The accuracy of the CSF absolute WBC differential was evaluated by comparing manual counts from 50 CSF patient samples to counts from the ADVIA 120 Hematology System Accuracy statistics are found in the table below Manual ADVIA 120 Parameter R Slope Intercept Mean Mean Bias MN 0 896 1 07 4 8 9 14 5 PMN 0 973 124 0 11 10 12 2 Neut 0 971 122 0 11 10 12 2 Lymph 0 859 0 88 4 7 10 8 2 Mono 0 849 1 69 1 4 1 4 3 CSF WBC Differential Relative Percentages The accuracy of the CSF WBC Differential relative percentages was evaluated by comparing manual counts from 50 CSF patient samples to counts from the ADVIA 120 Hematology System The WBC differential relative percentages were analyzed by paired t test and R mke analysis as recommended in CLSI Document M29 A3 The results below give a p value for the paired t test and the percentage of results falling within the binomial limits Regulatory Information Manual ADVIA 120 t test Within Parameter Mean Mean p value Binomial Limit MN 72 7 722 0 992 100 PMN 26 9 25 6 0 800 100 Neut 26 6 22 3 0 383 98 Lymph
48. 5 RDW 12 3 0 07 0 6 HDW g dL 2 56 0 02 0 8 PLT 107 uL 256 6 9 2 7 MPV fL 8 1 0 11 1 4 Performance Characteristics Correlation Data The performance of the ADVIA 120 Hematology System was compared with the performance of the Technicon He3 RTC System x using whole blood from 60 normal donors and 70 hospital donors with each sample run in duplicate n 260 Regulatory Information The following Regression statistics were computed using a protocol similar to that recommended in the NCCLS document EP9 A Method Comparison and Bias Estimation Using Patient Samples Approved Guideline 1995 Parameter WBC 103 uL RBC 10 uL HGB g dL fL CH pg CHCM g dL RDW HDW g dL PLT 103 uL MPV fL Comparative System Regression or Method Technicon He3 RTC Technicon He3 RTC Technicon He3 RTC Technicon He3 RTC Technicon He3 RTC Technicon He3 RTC Technicon He3 RTC Technicon He3 RTC Technicon He3 RTC Technicon He3 RTC x Technicon He3 RTC system y ADVIA 120 Hematology system Equation y 1 06x 0 74 0 98x 0 11 1 01x 0 2 0 90x 9 6 1 00x 1 2 1 17x 6 5 0 86x 1 3 0 98x 0 06 1 08x 2 0 0 76x 0 9 Performance Characteristics Carryover r 0 997 0 997 0 997 0 994 0 990 0 974 0 980 0 959 0 991 0 925 Sy x 1 42 0 07 0 2 1 1 0 6 0 5 0 6 0 13 24 0 4 Sample carryover for the ADVIA 120 Hematology System was measured for WBC RBC HGB and PLT The perf
49. 5097 USA Siemens Healthcare Diagnostics Ltd Sir William Siemens Sq Frimley Camberley UK GU16 80D The information in this operator s guide was correct at the time of printing However Siemens continues to improve products and reserves the right to change specifications equipment and maintenance procedures at any time without notice If the system is used in a manner differently than specified by Siemens the protection provided by the equipment may be impaired See warning and hazard statements Contents Contents B OM UD UC I WELCOME TO THE ADVIA 2120 HEMATOLOGY 1 1 OVERVIEW d M 1 2 idee iren diae einen er d 1 3 How THE ADVIA 2120 HEMATOLOGY SYSTEM WORKS eee 1 14 How THE ADVIA 2120 SOFTWARE 8 44446 020 1 15 RESULTS xr NR ERI RSV INSECTS NEP 1 18 SP CIFICATIONS demere eandem 1 19 TURNING THE SYSTEM ON OFF eene eee eren 402000040 600 00 04 00000000 2 1 OVERVIEW d 2 2 TURNING THE SYSTEM ON etes enzeee eren e er 2 2 TURNING THE SYSTEM 2 4 DAILY ROUTINE sessscciscssssscssisstscsssscsesesvecsesvsvecsooosdebiecsssessesensecbeseasesdsscadevisecsdsstussosestes 3 1 STARTING EACH SHIFET 5 2 rete ee tonto
50. 8 Close valve V74 and select V72 to open Make sure that V73 is closed 9 Repeat steps 4 and 5 10 Select V74 and V72 to close and select V73 to open 11 Repeat steps 4 and 5 12 Close valves V1 V47 and V73 Exit the Exerciser by selecting the Analyzer Status tab Cleaning the Shear Valve Materials required Time Cleaning 15 minutes e Beaker e Household bleach e Paper towels e Squirt bottle e Ultrasonic bath if available Checkout 15 minutes Analyzer mode Standby Clean the shear valve faces before recalibrating the system High volume laboratories or laboratories that handle dialysis samples or overly viscous blood such as aged samples may need to clean the shear valve faces more often BIOHAZARD All products or objects that come in contact with human or animal body fluids should be handled before and after cleaning as if capable of transmitting infectious diseases Wear facial protection gloves and protective clothing Maintaining the Analyzer 4 7 The operator should follow the recommendations to prevent the transmission of infectious agents in health care settings as recommended for potentially infectious specimens in Protection of Laboratory Workers from Infectious Disease Transmitted by Blood Body Fluids and Tissue 2d edition Approved Guideline 1997 Document M29 A National Committee for Clinical Laboratory Standards NCCLS This document contains complete information on user protection
51. ADVIA 2120 21201 SHEATH 0 022202 1 1 1 000000000 3 IMASUREMEN Ts 5 Gene ana E 4 BASO RATE 5 21 1 000000000000000000000000000000 4 BASOX HISTOGRAM 5 EA eie 5 BASO Y HISTOGRAM x 2 cider rere tee rie ETE iEn 5 BASO CYTOGRAM CLUSTER ANALYSIS 6 BASO CYTOGRAM HISTOGRAM ANALYSIS 0 00020000 00111 7 ABNORMAL CELL LOCATIONS csssssscscceceesesssceeeeccecsesseaeceecceceessaececeeecsensaeeeceeeceenenaeaa 9 CALCULATING PARAMETERS lt 2 522 creo ee ek sees de subdue eve Ea pases eaa e tects 11 CSE METHOD ec MH 16 CYTOCHEMICAL REACTIONS csssesscccececsessaececececsensaaececececsensaaececececeeneaeeeteeeeeeneaees 16 MEASUREMENT etait e E er eese ied aen drm eatem 16 CSF SCATTER SCATTER CYTOGRAM 0 11 2 0 000000000 000000000000 16 CSF SCATTER ABSORPTION CYTOGRAM scsscscscceceesessececececeeseaececececeeseneseseeeeeeneaees 16 CALCULATING PARAMETERG sssessscecececsessssececececeesssaececececsessaececececeeseaeceeeeseeeneaees 17 HEMOGLOBIN METHOD siscsssnccesssssesocsssnssessosensessssorsnssebanscassossasentesessersecsosensessssonsees 21 CHEMIGAT REACTIONS 21 esie Peto rS 21 BIBLIOGRAPHY e casae iere a eee te cei I etur e ERA 22 MBASURBEMENIE
52. ADVIA 2120 21201 system software is a special purpose program that runs on the Windows NT operating system You can navigate through the software and operate the system using the mouse Status lines Menus Tabs Left side buttons A N 5 Main display area 6 Bottom buttons Help button 8 Shortcut keys ADVIN2120 Status lines There are two status lines that display messages about the system Both lines consist of two parts each displaying different information The system saves all messages in the message log Click the message icon to view the last 10 messages First Status Line Left Side Next sample ID sample type and test requested Right Side Service Notepad Help Printer and Autoslide icons Welcome to the ADVIA 2120 2120i Hematology System Service appears when a scheduled service procedure is overdue Gray Autoslide indicates that communication to Autoslide is not connected Notepad appears when there is a new entry in the User Notepad Green Autoslide indicates that the Autoslide is ready Yellow Autoslide indicates that the Autoslide is busy or running utilities This may also indicate that the Autoslide is offline and in need of attention Red Autoslide indicates that a critical Autoslide error has occurred Autoslide Service appears when a scheduled Autoslide service procedure is overdue 22 To get brief What s This Help click the Help icon then click t
53. AN WARNING BIOHAZARD To avoid operator injury the access doors on ADVIA Autoslide Slide Maker Stainer are equipped with sensors that stop Autoslide operation when opened Wear personal protective equipment Use universal caution For complete biohazard statement refer to section on Autoslide Safety Information and Warnings When the front access door is opened during Autoslide operation the slide maker portion of the system stops slide transfer and staining continue to operate Stain overflow collection tray AN WARNING Staining reagents contain methanol that is flammable and toxic For complete methanol safety statement refer to section on Autoslide Safety Information and Warnings To avoid personal injury and damage to the instrument you must check the reagent overflow tray periodically to verify that there are no leaks of the reagents If liquid is present switch the instrument off discard the liquid into waste container using appropriate safety precautions and call your local technical service provider or distributor ADVIA Autoslide Slide Maker Stainer 10 3 Do not replace hoses Contact your local technical service provider or distributor for this procedure Stainer access door AN WARNING BIOHAZARD To avoid operator injury the access doors on ADVIA Autoslide Slide Maker Stainer are equipped with sensors that stop Autoslide operation when opened Wear personal protective equipment Use universal caution For c
54. B911 01 Coupling Disposable syringe Luer adapter e Pin vise e Household bleach e Lens tissue e One 6 inch 15 2 cm length of 0 020 inch 0 5 mm ID C Flex Tubing PN 562 3052P02 e Spectrophotometric grade methanol e Two 50 mL beakers Syringe preparation Time Replacement 10 minutes Checkout 30 minutes Analyzer mode Standby BIOHAZARD All products or objects that come in contact with human or animal body fluids should be handled before and after cleaning as if capable of transmitting infectious diseases Wear facial protection gloves and protective clothing The operator should follow the recommendations to prevent the transmission of infectious agents in health care settings as recommended for potentially infectious specimens in Protection of Laboratory Workers from Infectious Disease Transmitted by Blood Body Fluids and Tissue 2nd edition Approved Guideline 1997 Document M29 A National Committee for Clinical Laboratory Standards NCCLS This document contains complete information on user protection and it can be used as reference material for instructions on laboratory safety IMPORTANT An inspection scope must be available for this procedure Do not remove the flowcells unless you are trained in how to align and focus them To remove and clean the flowcells 1 Remove the flowcell There is a different procedure for each flowcell Take the flowcell apart Clean the CFM 2 3 4 Flush the flow
55. CHDWg MCVg MCVr RDWg RDWr Flags 6 33 6 34 Corrective Action 1 Flush the RBC Baso Retic flowcell 2 Perform the sheath reagent check 3 Remove and clean the RBC Baso Retic flowcell 4 Replace the laser diode No Perox NRBC Lymph Valley NRPXNV NV The No Perox NRBC Lymph Valley flag is triggered if there is no valley between the nRBC and lymphocyte populations when the system reports an NRBC count Results Flagged NRBC NRBC WBC NEUT NEUT LYMPH LYMPH MONO MONO EOS EOS 5 BASO LUC LUC The green circles in both the NRBC Enumeration histogram and Noise lymph histogram below show no valley separating lymphocyte events from the nRBC population The red arrow identifies the nRBC events NRBC Enumeration Histogram Noise Lymph Histogram Legend Perox Irregular Flow Rate PXIFR XR Definition The Perox Irregular Flow rate flag is triggered if the cell counting rate is erratic because of a hydraulic disturbance in the perox channel Perox flow rate is evaluated in terms of the cell counting rate Sum of the Squared Differences Flow Uniformity 9 x Mean Cell Counting Rate The flag is triggered if this value is greater than 3 2 Flags The Perox Rate Histogram displays the arrival rate of the cells in the perox channel Normal Perox Rate Histogram PXIFR Perox Rate Histogram ae Results Flagged WBCP NEUT NEUT LYMPH LYMPH MONO EOS
56. Critical system error Refer to the associated error message for occurred transferring the appropriate corrective action steps current system state to Aspiration Paused Atypical Lymphocytes Alarm The number of consecutive occurrences of this condition has met the criterion specified for an alarm message The specified alarm criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Alarm Criteria is automatically reset Status Line messages 7 11 7 12 Atypical Lymphocytes Stop The number of consecutive occurrences of this condition has met the criterion specified for a stop message The autosampler halts at the same time the stop message occurs The specified stop criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Stop Criteria is reset when the Start Stop button is selected Auto Rinse Started The Auto Rinse started on schedule Auto Rinse Canceled The System canceled the scheduled Auto Rinse in accordance with user cancellation Auto Rinse Missed The scheduled Auto Rinse was missed and did not occur while the Exerciser or System Setup tab was open Auto Standby Started The Auto Standby started on schedule Auto Standby Canceled The System canceled the scheduled Auto Standby in accordance with user cancellation Auto Standby Missed The scheduled Auto Standby was missed and did
57. Flags 2 Flush the flowcell Retic Absorption Distribution Abnormal RTCADA CA Definition The RTCADA flag is triggered if the absorption distribution for the gated cell population is abnormal The absorption distribution of the histogram is sufficiently abnormal that the reticulocyte population may not be gated correctly The flag is triggered if The mode of the calculated Gaussian fit for the absorption histogram is below channel 6 The mode of the calculated Gaussian fit for the absorption histogram is above channel 30 The SD of the absorption histogram Retic Abs above 80 of the original histogram height is greater than 1 4 The measured mean absorption Retic Abs F minus the theoretical absorption is greater than 30 Results Flagged RETIC CHg CHr CHCMg CHCMr CHDWr CHDWg MCVg MCVr RDWeg RDWr Corrective Action Multiple occurrences of this flag especially for consecutive samples can indicate a system problem However isolated instances of this flag are usually sample related The following list of sample related causes may not contain all conditions that could cause this flag There is no intention to associate the flag with specific diagnoses System Related Sample Related Flags 6 43 6 44 1 Check retic reagents e Aged blood 2 Check RBC Baso Retic hydraulics e Transfusion 3 Check retic hydraulics e Sickle cell anemia 4 Check sheath delivery e High num
58. Hematology system Performance Characteristics Carryover Sample carryover for the ADVIA 2120 2120i Hematology System is expressed as the percentage of a high level sample lost to a trailing low level sample Carryover was determined for the RBC count obtained from the reticulocyte channel RTC RBC Parameter Observed Carryover RTC RBC 1 0 Regulatory Information 9 61 9 62 Performance Characteristics Analytical Range The analytical range for parameter is Maximum Observed Parameter Range Evaluated Deviation 0 2 24 9 2 6 Regulatory Information Method Data Summary CBC Method Data The sample stability expected ranges and performance characteristics for the CBC method are listed in the following Table Sample Stability Expected Imprecision Correlation Data Observed Analytical Range Room Temp Refrigerated Values Mean SD CV y r Sy x Carryover Range Deviation WBC 10 uL 36h 56h 3 8 to 8 6 5 91 0 16 2 7 1 06x 0 74 0 997 1 42 0 4 0 02 to 21 83 0 46 x 10 uL 20 48 to 409 55 4 1 RBC 10 uL 48h 72h 4 1 to 6 0 4 82 0 05 1 0 0 98x 0 11 0 997 0 07 0 2 96 0 0 to 2 65 0 03 x 109 uL 2 65 to 6 76 1 1 HGB g dL 72h 72h 10 to 16 133 0 11 0 8 1 01x 0 2 0 997 0 2 0 2 0 0 to 8 6 0 2 g dL 8 6 to 22 5 2 5 96 MCV fL 8h 24h 76 to 100 81 0 0 3 0 4 0 90x 9 6 0 994 1 1 CH pg 36h 53h 24 to 35 265 0 05 0 2 1 00x 1 2 0 990 0 6 CHCM g dL 8h 24h 29 to 34 306 0 14 0 5 1 17x 6 5 0 974
59. Hemoglobin Colorimeter Assembly A Lamp Assembly Hgb Reaction Chamber UFC Assembly The hemoglobin colorimeter assembly straddles the UFC block C at the top The colorimeter contains a light source A set at 3 5 Vdc and a 565 nm or 546 nm interference filter according to the HGB method selected The hemoglobin reaction chamber B is built into the UFC assembly Hemoglobin concentration is calculated using baseline and sample readings taken at specific intervals during the hemoglobin sample analysis period Welcome to the ADVIA 2120 2120i Hematology System 1 9 1 10 These voltage readings correspond to the amount of transmitted light that passes through the reaction chamber when it contains sample mixed with reagent or rinse The voltage readings are then converted to a digital form by the Hgb Interface Board and sent to the analyzer CPU to calculate the optical density and derive the Hgb concentration Sample Sheath and Diaphragm Pumps The perox sample 1 and sheath 2 pumps are located on the left side of the analyzer The RBC baso retic sample 3 and sheath 4 pumps are located on the right side of the analyzer The diaphragm pumps for sheath rinse and wash five in all are located above the reagent containers Welcome to the ADVIA 2120 2120i Hematology System The sample pumps 1 dispense an exact amount of reacted sample 2 from the appropriate reaction D chamber
60. Hold the sheath filter by its body at all times and do not use excessive force when the lines are being connected Still holding the filter by the center of the body connect the reagent line to the barbed fitting of the input port Insert the sheath filter into the mounting clip with the input end of the filter facing up Prime the reagent lines five times A CAUTION Do not use a syringe to prime the filter It may cause damage to the filter Look at the level of the liquid in the sheath filter If the filter is not approximately 90 full run two additional prime cycles Replacing the 50 or 1000 uL Syringe Plungers PN 067 506 01 and 067 506 02 4 16 Materials required Time 15 minutes Analyzer mode Off NOTE Hex wrench small Household bleach Sample syringe repair kit PN 067 B506 01 50 uL Sheath syringe repair kit PN 067 B506 02 1000 uL The sheath syringe plungers 1 will Maintaining the Analyzer last two to three times longer than the sample syringe plungers 2 BIOHAZARD All products or objects that come in contact with human or animal body fluids should be handled before and after cleaning as if capable of transmitting infectious diseases Wear facial protection gloves and protective clothing The operator should follow the recommendations to prevent the transmission of infectious agents in health care settings as recommended for potentially infectious specimens in Protection o
61. MD Tyson ST Steele CR Leukocyte survival in cerebrospinal fluid J Clin Microbiol 23 965 966 1986 Editors C Kjeldscberg and J Knight Body Fluids Third edition Chicago IL ASCP Press pp 65 157 1993 National Committee for Clinical Laboratory Standards Approved standard H20 A reference leukocyte differential count proportional and evaluation of instrumental methods Villanova Pennsylvania National Committee for Clinical Laboratory Standards 1992 Riimke C L The statistically expected variability in differential leukocyte counting In Differential Leukocyte Counting J A Koepke ed Skokie Illinois College of American Pathologists 1978 Reagent ADVIA 120 CSF Reagent Product Number Symbol Contents Amount mL 01 4610 01 CSF Reagent 1 8 01 4611 01 CSF Reagent 8 mL ADVIA 120 CSF Reagent contains a sphering agent and fixatives in a buffered aqueous solution The ADVIA 120 CSF Reagent PN T01 4610 01 contains one 8 mL bottle with sufficient reagent to analyze 25 samples or controls ADVIA 120 CSF Reagent contains Formaldehyde 296 Wt Glutaraldehyde 0 28 Wt Buffer Surfactants Regulatory Information x HARMFUL IRRITANT Contains 2 Wt formaldehyde Limited evidence of a carcinogenic effect May cause sensitization by skin contact Wear suitable protective clothing and gloves R40 R43 536 37 For in vitro diagnostic use Storage and Stability Reagents When stored b
62. Manager and cannot be transmitted to the host Status Line messages Corrective Action Call Siemens Service for assistance Invalid Numerical Result Format A result edited in the Review and Edit window has a format incompatible with the communications protocol Corrective Action Verify that the format shows four results of one character each Invalid RBC or WBC Flag The RBC or WBC has incorrect or undefined values in the analyzer The sample will not be transmitted to the host Corrective Action Verify that the result is composed of four results of one character each Invalid System Number The computer system number as it applies to the host is improperly defined or undefined in the parameter file Corrective Action Call Siemens Service for assistance Invalid Test Code in Report par File A test code entered in the Report par file is not valid Corrective Action Correct problem using Key list in Format window Status Line messages 7 57 7 58 Large Platelets Alarm The number of consecutive occurrences of this condition has met the criterion specified for an alarm message The specified alarm criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Alarm Criteria is automatically reset Large Platelets Stop The number of consecutive occurrences of this condition has met the criterion specified for a stop message The autosampler halts
63. RBC PLT reagents e Contact your Siemens Field Service Representative RBC Irregular Flow Rate RBCIFR RR Definition 6 41 6 42 The RBC Irregular Flow Rate flag is triggered if the cell counting rate is erratic because of a hydraulic disturbance in the RBC PLT channel RBC flow rate is evaluated in terms of the cell counting rate Sum of the Squared Differences Flow Uniformity 9 x Mean Cell Counting Rate The flag is triggered if this value is greater than 3 2 The RBC Rate Histogram displays the arrival rate of cells in the RBC channel Normal RBC Rate Histogram RBCIFR RBC Rate Histogram sat Results Flagged RBC HCT MCV MCH MCHC CHCM CH CHDW RDW HDW PLT MPV PDW Corrective Action 1 Check RBC reagents 2 Check RBC hydraulics 3 Check sheath delivery 4 Check the pressure and vacuum readings A partially clogged RBC baso retic sheath filter can produce a distinctive ski slope effect on the RBC Baso and Retic flow rate histograms Replace the sheath filter RBC Rate Baso Rate Retic Rate Retic Pit Interference Error RTCint CT Definition The RTCint flag is triggered if the platelet threshold is set below scatter channel 5 If the flag is triggered platelets may be counted in the gated mature RBC population Results Flagged RETIC CHg CHr CHCMg CHCMr CHDWeg CHDWr MCVg MCVr RDWg RDWr Corrective Action 1 Check retic reagents
64. Siemens authorized representative which is the Siemens contact within the European community e addresses for obtaining service and technical information and for ordering supplies e system warranty and service delivery policy information Limited Instrument Warranty and Service Delivery Policy A 2 Siemens and its authorized distributors may provide customers who acquire new Siemens instruments with a limited warranty either in a specific agreement or in standard language on their invoices This limited warranty is designed to protect customers from the cost associated with repairing instruments that exhibit malfunctions due to defects in materials and or workmanship during the warranty period Siemens at its election provides warranty service either by providing repair service of the instrument on site or by exchanging the defective instrument or component subject to the limitations and exclusions set forth in Replacement of Parts and Warranty and Service Exclusions below Repairs replacements or exchanges of instruments or components provided during the warranty or any additional service period does not extend the warranty or service period beyond the initially agreed upon period When the customer calls for service the Siemens representative or authorized distributor informs the customer of the type of service available for the customer s instrument and instructs the customer as to how to obtain that service Warranty Period
65. Straighten or reconnect lines as necessary If problems persist Call Siemens Service for assistance Further corrective action must be taken by Siemens service personnel only Communications Error with Analyzer Software communication error between the computer and the analyzer Possible Cause 1 Internal software corruption Status Line messages Corrective Action a b Reset the analyzer by selecting Utilities Exerciser Indicators Analyzer Reset After about 1 minute if the status line does not display Ready to Run and the green ready to aspirate light is still off follow these steps to exit the ADVIA 2120 21201 software turn off the analyzer and then restart i Select Shut Down ADVIA at the Log On Off window ii Select Off at the analyzer touchpad iii Select CTRL ALT DELETE and log back onto the system to restart the software 7 43 7 44 iv Restart the analyzer by selecting On at the analyzer touchpad 2 Faulty or Verify that the Ethernet connection is secure Replace if disconnected necessary Ethernet cable from the analyzer J2 Workstation connection to the computer Comparison Error MCHC CHCM Alarm The number of consecutive occurrences of this condition has met the criterion specified for an alarm message The specified alarm criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Alarm Criteria is automatically reset
66. To avoid serious irreversible effects do not inhale do not contact with skin and do not swallow Wear suitable protective clothing and gloves In case of accident or if you feel unwell seek medical advice immediately FLAMMABLE Methanol is flammable Keep away from sources of ignition no smoking Make sure all slides are processed and transferred to the output queue before turning off the Autoslide Turning off the autoslide while slides are processing can cause unreliable results and possibly damage Autoslide components 1 Put the analyzer in Standby mode and turn off the Autoslide 2 Slide open the stainer tray door 3 While manually rotating the stainer plate remove the stainer wells by gently sliding each out of the stainer ADVIA Autoslide Slide Maker Stainer 10 41 Do not put too much force on the staining wells when removing them Pulling up or out too hard may damage the wells They should be clipped gently into and out of place on the stainer plate Place the stainer wells in a tray with enough methanol to completely cover them Agitate the tray to remove any air bubbles 4 While the wells are soaking use a soft cloth or paper towel to clean the stainer plate Rotate the plate manually to clean the entire surface 5 After the wells have soaked in the methanol for ten minutes remove them from the tray and dry them with paper towels 10 42 ADVIA Autoslide Slide Maker Stainer 6 While manually ro
67. and practices are not strictly observed When this symbol appears on the system without additional information you must consult the instructions for use Biohazard The biohazard warning label mounted on the front of the analyzer alerts you to the possibility of exposure to a biohazard during the sampling process or through contamination of the analyzer This symbol identifies a product that may contain an infectious agent This symbol alerts you to a potentially harmful substance These symbols together alert you to a waste biohazard Laser hazard Electrical hazard This symbol indicates an in vitro diagnostic device or an in vitro diagnostic medical device This symbol indicates that you should consult the operating instructions for necessary information B 5 B 6 2 o 2 L 3 C Class 1 Laser Product Hi This symbol indicates the number used for ordering a part or product This symbol indicates the serial number of a part or product This symbol indicates the batch code for a product This symbol indicates the name and location of the product manufacturer This symbol indicates the date of manufacture of the product This symbol indicates the manufacturer s authorized representative within the European community This symbol indicates that the product complies with the applicable directives of the European Union This symbol indicates that t
68. and it can be used as reference material for instructions on laboratory safety To clean the shear valve 1 Take the shear valve apart 2 Clean the shear valve 3 Reassemble the shear valve 4 Check the analyzer Cleaning the Shear Valve Step 1 Taking the Shear Valve Faces Apart IMPORTANT Place paper towels directly under the shear valve to prevent fluid from dripping down into the analyzer Remove the knurled nut 1 by turning counter clockwise then remove the compression spring 2 2 To remove the rotor 3 hold the shear valve with one hand and with the other hand rotate the rotor until it can be pulled forward and off the shaft Maintaining the Analyzer 3 To remove the front shear face 4 gently rotate the front face until it is loosened then pull forward and remove The rear shear face is stationary AN CAUTION To avoid damaging the seal that secures the shear valve to the acrylic layer of the UFC do not use excessive force to remove the front shear face DO NOT use sharp objects such as a screwdriver to separate the shear faces If you have difficulty removing the rotor or the front shear face hold paper towels under the shear valve and squirt the valve with a stream of warm water If the rotor is off squirt some water into the two holes in the front of the shear face Allow it to soak for a few minutes then remove the rotor and or shear face If you still have difficulty separa
69. are ta 18 MAIN DISPLAY AREA atan iret eie rte e ua RA a cid 18 BOTTOM BUTTONS 3 ette SU 18 HELPBUTTON EHE 18 SHORTCUT KEY Sis acne mation RI 18 WIZARDS ha m ut ai eara ds ria a atc Se a ans 18 PRINTING THE SCREEN ink saoer dorea resia Taa aT EOE EEEE SE TEn ERSTES Eea Eos i aai 19 RESUET SS SE E E E E EIE EIIE NO ET o 20 gorelo ef wu O fce M 21 SERE TEUER UN EPE ERES RUNE TERN soos A EENQ SERERE EE QR 21 DATA MANAGEMENT arinetan 0 3 oido tO e RU RETO EOS 21 PARAMETERS 5 n eire er ee er dete vates Wave Bes tis eram 22 PERFORMANCE 8 202 2 42 000 00100000000000000000000000 23 PERSONAL COMPUTER SPECIFICATIONS MINIMUM eese enne 23 PHYSICAL SPECIFICATIONG ccesssssscssccecessenscssccececssnseeseccececesnscececescecesnseaeeeescsseenseeees 24 SAMPLE MODE VOLUMBS 5 25 TEST SELECTIVITY THROUGHPUT ccccesssssscecececsesssaececececsessnececececeesenseseeeeeeeeneaees 25 Welcome to the ADVIA 2120 2120i Hematology System 1 1 Overview The ADVIA 2120 2120i Hematology System is a fully automated diagnostic instrument with a throughput of 120 samples per hour CBC diff The analyzer uses whole blood samples to provide the following type
70. at the same time the stop message occurs The specified stop criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Stop Criteria is reset when the Start Stop button is selected Laser Power Low Alarm The number of consecutive occurrences of this condition has met the criterion specified for an alarm message The specified alarm criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Alarm Criteria is automatically reset Laser Power Low Stop The number of consecutive occurrences of this condition has met the criterion specified for a stop message The autosampler halts at the same time the stop message occurs The specified stop criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Stop Criteria is reset when the Start Stop button is selected Left Shift Alarm The number of consecutive occurrences of this condition has met the criterion specified for an alarm message The specified alarm criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Alarm Criteria is automatically reset Status Line messages Left Shift Stop The number of consecutive occurrences of this condition has met the criterion specified for a stop message The autosampler halts at the same time the stop message
71. background counts are not acceptable perform one aspiration of a 25 bleach solution once followed by two aspirations of distilled water or saline The recommended values for these limits are CSF R Count 0 CSF PHA WBC 0 CSF PHA Total lt 10 If background counts are not acceptable perform one aspiration of a 25 bleach solution once followed by two aspirations of distilled water or saline NOTE The CSF Wash cycle rinses the sample pathways without performing a background count The CSF Refresh cycle refreshes the flow cell background count without rinsing the sample pathways The background counts are stored in the startup log Select Primer as the Sample Type and select OK Aspirate a saline primer to verify that background counts in the sample pathway are within acceptable limits Make sure that Primer displays on the status line before aspiration If background counts are acceptable proceed to step 8 If not perform one aspiration of a 25 bleach solution followed by three aspirations of distilled water or saline and repeat steps 5 and 6 Select the correct sample type and then enter the sample or control information in the Manual Sample ID box or scan the barcode on the sample tube Do not use sample barcode labels with selectivities encoded in them to enter sample identifications type appears on the status line before aspirating a sample CAUTION Make sure the correct sample ID and sample Regulatory Informatio
72. be of use in differentiating two types of microcytic anemia Bibliography D Onofrio G Zini G Ricerca B M Mancini S and Mango G Automated measurement of red blood cell microcytosis and hypochromia in iron deficiency and B thalassemia trait Arch Pathol Lab Med 116 84 1992 Methods Methods Calculating Platelet Parameters Reported Parameters Parameter Explanation PLT Corrected PLT Count x RBC Cal Factor x PLT Cal Factor x Dilution Factor MPV Mean of Platelet VOL histogram Additional Parameters The following parameters are for research or laboratory use only and are not for patient reporting Parameter Large PLT MPC MPM PCDW P Count 2D PCT PDW PLT N PLT X PLT Y PMDW R Count 2D RBC 2D Count Explanation Platelets with volumes greater than 20 fL Mean of Platelet PC histogram Mean of Platelet PM histogram SD of Platelet PC histogram Raw cell count for platelets and large platelets from 2D platelet analysis PLT x MPV 10 000 100 x SD of Platelet VOL histogram MPV Mean of refractive index values for platelets only Mean of high angle high gain values for platelets only Mean of low angle high gain values for platelets only SD of Platelet PM histogram Raw cell count for RBCs RBC ghosts and RBC fragments from 2D platelet analysis Number of Red Cells 2D from 2D platelet analysis x RBC Cal Factor x Dilution Factor x Coincidence cor
73. bleach and water to clean it Rinse thoroughly with water 6 Install the new plunger a f a o Insert the pin gauge 7 from the repair kit into 6 the input port of the syringe Wet the plunger with saline solution and insert it into the syringe barrel Slide the plunger up until it touches the pin gauge AN CAUTION Do not force plunger into the syringe Forcing will distort the tip Co 4 E 5 On the 50 uL syringe replace the small plastic bushing into the syringe Replace the metal bushing onto the plunger stem with the narrow collar of the bushing 5 toward the plunger 6 6 Push the metal bushing up against the syringe then tighten the set screws 4 5 Remove the pin gauge from the input port a Reinstall the sample syringe With the metal bushing end first insert the syringe plunger into the slot at the bottom of the carriage Slide the syringe up and into the mounting hole in the pump drive frame with the input port facing left on the RBC baso retic channel and facing right on the perox channel Install the washer and the knurled nut and hand tighten the nut AN CAUTION Be careful not to cross thread or overtighten the knurled nut and the input output fittings Reconnect all the tubing to the syringe fittings Maintaining the Analyzer 8 Check analyzer performance by e Checking saline backgrounds e Running a whole blood primer e Running controls If contr
74. by selecting Utilities Exerciser Indicators Analyzer Reset b After about 1 minute if the status line does not display Ready to Run and the green ready to aspirate light is still off follow these steps to exit the ADVIA 2120 21201 software turn off the analyzer and then restart i Select Shut Down ADVIA at the Log On Off window ii Select Off at the analyzer touchpad iii Select CTRL ALT DELETE and log back onto the system to restart the software iv Restart the analyzer by selecting On at the analyzer touchpad Call Siemens Service for assistance Status Line messages Scrambler Board or Can Bus Scrambler Board SHEATH RINSE Reagent Container Empty SHEATH RINSE level has dropped below the level sensor in the SHEATH RINSE container indicating that the container is empty When this error message is displayed the aspirate plate will not function nor will the Ready light illuminate Possible Cause Corrective Action 1 SHEATH RINSE Replace SHEATH RINSE reagent and use the message is empty icon to Remove the error message 2 Faulty level Call Siemens Service for assistance sensor SHEATH RINSE Reagent Expired Present date is beyond the SHEATH RINSE reagent expiration date as determined by encoded reagent container barcode label or as calculated from installation date and open container stability Corrective Action Replenish expired reagents and update the Reagent Installation window Go to Logs Rea
75. communication the indicator stays red until you send the first sample Once you send the sample the indicator turns green and stays green even after you disconnect the host computer cable from your PC No Sound When Viewing Videos If there is no sound when you are viewing a video adjust the sound on your monitor Refer to the instructions in the manual shipped with the monitor you are using There is no sound with animations Troubleshooting the Analyzer Perox Chamber PEROX 3 reagent is used up before PEROX 2 reagent bottle is empty Perox reaction chamber overflows e Check for blockage in the perox reaction chamber cap Clear any blockage using a drill bit or a paper clip e Check for blockage or crimps in the perox overflow tube e Make sure that the ends of the tubes do not touch the bottom of the overflow bottle nor are they submerged in liquid NOTE If the opening on overflow bottle cap is not large enough and pinches the tubes cut the rubber cap from the outside edge to the inner opening to relieve some of the pressure on the tubes Troubleshooting the Analyzer 5 51 Flags Flags MORPHOLOGY FLAGG ssscsssssscssssecscossosssosesosssosssnssonsssscvessnesssessessvessnessesseenseoees 3 SUMMARY enu rit eta A eto 3 ANISOCYTOSIS 15 2 1 02 7 0000000000000000000000000000 4 ATYPICAL LYMPHOCYTES AT YP eei EE 5 BLASTS BLASTS i s amete eA RI RAR eR 6 HGB CONCE
76. condition has met the criterion specified for a stop message The autosampler halts at the same time the stop message occurs The specified stop criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Stop Criteria is reset when the Start Stop button is selected PEROX Sample Pump Error Reset Required PEROX sample syringe pump not in home position failed to respond or a transmission error occurred Possible Cause 1 sample syringe pump not moving or not in home position 2 PEROX sample syringe incorrectly assembled 3 Faulty power supply fuse cable pump assembly Can Bus Scrambler Board or Dual Servo Pump Control Board 7 72 Corrective Action a b Reset the analyzer by selecting Utilities Exerciser Indicators Analyzer Reset After about 1 minute if the status line does not display Ready to Run and the green ready to aspirate light is still off follow these steps to exit the ADVIA 2120 21201 software turn off the analyzer and then restart i Select Shut Down ADVIA at the Log On Off window ii Select Off at the analyzer touchpad iii Select CTRL ALT DELETE and log back onto the system to restart the software iv Restart the analyzer by selecting On at the analyzer touchpad Follow the steps in Replacing the Syringe Plungers Call Siemens Service for assistance Status Line messages PEROX Saturation Ala
77. correctly followed Hazards associated with the presence handling or use of required reagents are categorized as follows CAUTION Indicates a hazard that could cause illness burns skin reactions and so on Substances such as diluted acids mild caustics minor skin irritants and combustible materials are assigned to this category ATTENTION Indicates that a specific risk exists to the user or performance Refer to the labels on the reagent containers and to the Material Safety Data Sheets for information about the hazards and precautions associated with the reagents System Symbols This section describes the symbols that can appear on the exterior of the ADVIA 2120 21201 system or on the system packaging The symbols on the system provide you with the location of certain components and with warnings for proper operation The symbols on the system packaging provide you with other important information B 4 Warnings and Safety Information AN Attention Atenci n Cuidado gt e Biohazard Danger biologique Peligro biol gico Risco biol gico N4AINF K x Ab gt Warnings and Safety Information Warnings and Cautions e A Warning indicates the risk of personal injury or loss of life if operating procedures and practices are not correctly followed e A Caution indicates the possibility of loss of data or damage to or destruction of equipment if operating procedures
78. criterion specified for a stop message The autosampler halts at the same time the stop message occurs The specified stop criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Stop Criteria is reset when the Start Stop button is selected Aspiration Failed Probe Clog Alarm Conductivity detectors did not detect a sample within the 20 seconds of aspiration The number of consecutive occurrences of this condition has met the criterion set for an alarm message Status Line messages 7 9 7 10 Possible Cause 1 Clogged sample 2 Insufficient sample volume Sample tube may have been removed before aspiration was complete 3 Insufficient vacuum 4 Clogged clot filter 5 Loose connection in sample line 6 Clog in needle 7 Bent damaged needle 8 Faulty Conductivity Detector Corrective Action Check for sample clots Re aspirate sample Check vacuum gauge and adjust if necessary Remove clot filter and discard as biohazardous material Replace clot filter Check connections and tighten if necessary Perform a needle rinse Select Utilities menu Hydraulic Functions tab Needle Rinse Replace the needle Follow the steps in Replacing the Sampler Needles Contact your Siemens Field Service representative for assistance Aspiration Failed Probe Clog Stop Conductivity detectors did not detect a sample within the 20 second
79. criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Stop Criteria is reset when the Start Stop button is selected HGB Reagent Empty Stop The number of consecutive occurrences of this condition has met the criterion specified for a stop message The reagent is empty and the autosampler has halted The specified stop criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria Reagent Conditions Corrective Action The stop counter is automatically reset after reagents are replenished and the Reagent Installation window is updated Go to Logs Reagent Log Reagent Installation Select Start Stop to continue the run Status Line messages 7 51 HGB Reagent Expired Present date is beyond the HGB reagent expiration date as determined by encoded reagent container barcode label or as calculated from installation date and open container stability Corrective Action Replenish expired reagents and update the Reagent Installation window Go to Logs Reagent Log Reagent Installation HGB Reagent Low Alarm The number of consecutive occurrences of this condition has met the criterion specified for an alarm message indicating the reagent level is low The specified alarm criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria Reagent Conditions Corrective Action The alarm counter is automatically reset after reag
80. for neutrophil cluster Valley channel between Noise and Lymph clusters Lymph Mode Count Noise Lymph Valley Count Lymph Mode Count 100 x FracDT 100 x Noise PHA Cells 100 x Perox Saturation PHA Cells Sum of theSquared Differences 9 x Mean Cell Counting Rate The white blood cell count from the Peroxidase method 9eNEUT The percent of neutrophils NEUT The absolute count of neutrophils 8 33 8 34 Neutrophil Count The number of events in the Neutrophil area 1 of the PEROX cytogram LYMPH The percent of lymphocytes LYMPH The absolute count of lymphocytes Lymphocyte Count The number of events in the Lymphocyte area 1 of the PEROX cytogram MONO The percent of monocytes MONO The absolute count of monocytes Monocyte Count The number of events in the Monocyte area 1 of the PEROX cytogram Methods Methods EOS The percent of eosinophils EOS The absolute count of eosinophils Eosinophil Count The number of events in the Eosinophil area 1 of the PEROX cytogram LUC The percent of large unstained cells LUC The absolute count of large unstained cells Large Unstained Cell Count The number of events in the LUC area 1 of the PEROX cytogram RawWBC Perox Valid Cells x PHA Cells PHA Total PeroxCalFactor The sampler specific calibration factor PeroxCalFactor PEROX WBC AS x 0 001248 PeroxCalFactor PERO
81. from shattered glass wear safety glasses when handling tungsten halogen lamps To avoid severe burns allow sufficient time for the lamp to cool After the analyzer is turned off wait at least 10 minutes AN CAUTION Fingerprints on the lamp could cause severe degradation in lamp performance DO NOT touch the lamp with your fingers Material required Replacement lamp PN 065 B075 01 Time Replacement 20 minutes Adjustment and checkout 20 minutes Analyzer mode Off wait at least 10 minutes A ELECTRICAL WARNING To avoid exposure to shock hazards and or damage to the instrument while performing this procedure power off the analyzer before proceeding To replace the perox lamp 1 IMPORTANT Make sure that the power is off before disconnecting the lamp 1 Disconnect the lamp power connector 2 in the back of the perox optics assembly by squeezing the sides of the red connector and pulling it apart FRONT OF ANALYZER Troubleshooting the Analyzer 2 Unscrew the securing cap to which the power cable 2 is attached Carefully pull the lamp assembly out of the optics lamp housing The lamp assembly includes the VIEW FROM lamp the power cable and the securing Discard the entire assembl P ap y OPTICS ASSEMBLY 3 Insert the replacement lamp assembly AN CAUTION Do not touch the glass bulb If necessary clean with lens paper and methyl alcohol 4 Replace the securing cap then connect th
82. front cover and remove the slide rack loader to gain easy access to the printer ribbon ADVIA Autoslide Slide Maker Stainer 10 45 10 46 NOTE Removing the slide rack loader will cause an ASL Stop condition This message will clear when you perform an Autoslide Mechanical Initialization at the end of this procedure 3 Holding both sides of the printer cartridge press toward the inside of the Autoslide and pull the cartridge out of its holder Be careful not to tangle the ribbon when removing it 4 Install the new printer cartridge securely in its holder Make sure the notches on the cartridge are positioned correctly in the holder 5 Replace the slide rack loader close the lower front cover 6 Place the analyzer in Ready mode then turn the Autoslide on Wait a few seconds The Autoslide will perform a Mechanical Initialization You must wait for the initialization to execute automatically Replacing the Autoslide Fuses IMPORTANT Do not attempt to replace the Autoslide fuses For replacement of all Autoslide fuses call your Siemens technical support provider or distributor ADVIA Autoslide Slide Maker Stainer Error Messages and Suggested Actions The list below contains explanations and actions for the Autoslide errors which may occur In some cases the suggested action will refer you to the troubleshooting tip s below to help you resolve the problem and restore your system to normal operating status A Fai
83. front face 3 Replace the spring 3 and the knurled nut 4 Hand tighten the nut Cleaning the Shear Valve Step 4 Checking Analyzer Performance Check analyzer performance by e Checking saline backgrounds e Running a whole blood primer e Running controls If controls do not recover calibrate affected channel Inspecting and Cleaning the Syringe Plungers PN 067 506 01 and PN 067 506 02 4 10 Inspect the tip of the plunger during a saline prime The normal wear of the plunger tip sheath 1 1000 uL syringe and sample 2 50 uL syringe against the syringe barrel can cause small pieces to be detached These small particles appear as a gray gel at the tip of the plunger If this gel enters the hydraulic system it can cause clogs in the analyzer Clean if necessary Materials required e Lint free tissue e Small hex wrench Maintaining the Analyzer Time 15 minutes for one plunger Analyzer mode Off BIOHAZARD All products or objects that come in contact with human or animal body fluids should be handled before and after cleaning as if capable of transmitting infectious diseases Wear facial protection gloves and protective clothing The operator should follow the recommendations to prevent the transmission of infectious agents in health care settings as recommended for potentially infectious specimens in Protection of Laboratory Workers from Infectious Disease Transmitted by B
84. if desired Cycle Aborted for Unknown Reason Reset Required A cycle abort condition was triggered by the analyzer but the reason given was not recognized by the computer Corrective Action 1 Reset the analyzer by selecting Utilities Exerciser Indicators Analyzer Reset 2 After about 1 minute if the status line does not display Ready to Run and the green ready aspirate light is still off follow these steps to exit the ADVIA 2120 21201 software turn off the analyzer and then restart a Select Shut Down ADVIA at the Log On Off window b Select Off at the analyzer touchpad Select CTRL ALT DELETE and log back onto the system to restart the software d Restart the analyzer by selecting On at the analyzer touchpad Data Manager Critical Error An internal software communication error has triggered a high level Data Manager error Corrective Action 1 Select Shut Down ADVIA at the Log On Off window 2 Select CTRL ALT DELETE and log back onto the system to restart the software If the problem persists call Siemens Service for assistance Defined More Than Once In File Note This message can begin with a keyword or a test code Possible Cause Corrective Action 1 The same keyword is set Use the Format window to correct the file several times in the header of layout the Report par Prevalid par Print par or QCreport par files No blank or presentation line can be inserted after the asterisk in the result
85. in place it can break as the assembly is tilted 3 Loosen the thumb screws 2 and tilt the autosampler aspirator assembly forward 4 Pull up the spring loaded knob 3 turn it a turn then remove the centering collar 4 by pulling it up and out NOTE If the centering collar is locked into place squirt a little warm DI water over the collar to loosen it 5 Place the red needle cover over the needle 6 Remove the three tubes from the collar To remove the centering collar from the manual closed tube sampler 1 Tilt the front cover down 2 Pull the centering collar up 3 Remove the tubing from the nipple 4 Place the red needle cover over the needle Cleaning the Shear Valve and Aspiration Pathways in the UFC Time 15 minutes 4 6 Maintaining the Analyzer Materials required Beaker household bleach and water Analyzer mode Ready to Run To clean the shear valve and aspiration pathways in the UFC 1 At the Utilities menu select the Exerciser tab 2 Select the Syringe Pumps button on the left If the arrow on the image of the valve under Selector Valve does not point to Open select on the image until the arrow does point to Open Select Valves on the left Select valve V72 to close Select valves V1 V47 and V74 to open Closed valve Qv Ende gt Hold a beaker of household bleach under the open tube sample probe until 5 mL is aspirated Opened valve A Repeat step 4 using 5 mL of water
86. iv Restart the analyzer by selecting On at the analyzer touchpad 2 The cable connected to Select Off at the analyzer touchpad to check for the switch indicator is crimped cable Free the crimped cable if crimped necessary and restart the analyzer by selecting On at the analyzer touchpad 3 Faulty power supply Call Siemens Service for assistance fuse Switch Indicator board cable Parallel Node Board Can Bus Scrambler Board or Switch Indicator panel Initialization Failed During Communication from Analyzer Software communication error Corrective Action Follow these steps to exit the ADVIA 2120 21201 software and then restart 1 Select Shut Down ADVIA at the Log On Off window 2 Select CTRL ALT DELETE and log back onto the system to restart the software If the problem persists call Siemens Service for assistance Initialization Failed During Configuration Download Software communication error Corrective Action Follow these steps to exit the ADVIA 2120 21201 software and then restart 1 Select Shut Down ADVIA at the Log On Off window 2 Select CTRL ALT DELETE and log back onto the system to restart the software If the problem persists call Siemens Service for assistance Initialization Failed During Download of Cycle Definition Software communication error Status Line messages Corrective Action Follow these steps to exit the ADVIA 2120 2120i software and then restart 1 Select Shut Down ADVIA at
87. level control to Hemolytic anemias check accuracy results are acceptable calibrate RBC MCV and HGB parameters b Ifthe HGB results are faulty troubleshoot the hemoglobin channel c IfRBC or MCV results are faulty troubleshoot the RBC channel 6 31 6 32 Comparison Error WBCB WBCP WBC CE WC Definition The Comparison Error WBCB WBCP flag is triggered if the difference in the WEC counts obtained from the baso and perox channels exceeds a preset limit The WBC count for each sample is independently determined in the baso channel WBCB and the perox channel WBCP The flag is triggered if e WBCB WBCP 2 1 0 x 103 uL when gt 2 0 x 105 uL and 10 0 x 103 uL WBCB WBCP gt 10 of WBCB when WBCB gt 10 0 x 108 uL e WBCB WBCP gt 20 of WBCB when gt 2 0 x 105 uL Results Flagged WBC NEUT NEUT LYMPH LYMPH MONO EOS EOS BASO BASO LUC LUC Corrective Action Multiple occurrences of this flag especially for consecutive samples can indicate a system problem However isolated instances of this flag are usually sample related The following list of sample related causes may not contain all conditions that could cause this flag There is no intention to associate the flag with specific diagnoses System Related Sample Related 1 If the Perox Noise PX NO and or No e Incomplete red cell Valley Perox PX N
88. must be taken by Siemens service personnel only Unable to Process Results Check Instrument Parameterization The image result does not match the numeric result Corrective Action Call Siemens Service for assistance Unable to Process Results Communication Line Fault A defect on the communication line has made the numeric results unreadable Corrective Action Call Siemens Service for assistance Unable to Process Results Too Long The IDee received from the analyzer is longer than 14 digits Corrective Action Status Line messages 7 95 7 96 Check the length of the sample ID Unknown Host Test Number xx A workorder from the host contains a test that is not defined in the Test Dictionary or contains an incorrect host number Corrective Action Modify the Test Dictionary or correct the host test table Do not modify the Test Dictionary while samples remain in the database Vacuum Out of Range System vacuum is out of range Possible Cause Corrective Action 1 Vacuum gauge Check the system vacuum gauge and adjust the regulator is out of range if necessary Setpoint 20 Hg 1 2 Vacuum leak Check for crimped or disconnected hydraulic or pneumatic lines Straighten or reconnect lines as necessary b Check the waste container to make sure that the spigot is closed and the cap is on securely Vacuum Out of Range Stop System vacuum is out of range Possible Cause Corrective Action 1
89. necessary for obtaining results for undiluted samples samples prepared 1 1 with CSF reagent and displays them on the Run Screen ADVIA 2120 2120 results should be reviewed for conditions listed in the Limitations of the Procedure If a sample displays any of the listed conditions the results should be confirmed The results of samples that have been diluted with PBS or normal saline prior to preparation with CSF reagent must be corrected for the dilution factor If a sample is diluted the absolute counts should be multiplied by the dilution factor Enter the dilution factor in the Dil field of the Order Entry tab when creating the workorder The results displayed in the Review Edit tab and printed on the final patient report will be automatically corrected by the entered dilution factor For example if a sample is diluted 1 5 1 part sample and 4 parts normal saline or PBS the absolute counts will be multiplied by 5 The differential percentages are not affected by dilution and will not be multiplied by the dilution factor when correcting on the Review Edit tab Results on the Run Screen are not corrected for the dilution factor The Laser Power Low PL system flag is enabled for CSF analysis High Low flagging is provided for all CSF parameters through range definitions set in the Data Manager Limitations of the Procedure The limitations of the procedure are as listed 1 CSF WBC percent differential results for samples wit
90. not occur while the Exerciser or System Setup tab was open Auto Startup Exiting Standby The System moved from Standby to Ready to Run enabling the scheduled Auto Startup Status Line messages Auto Startup Started Auto Startup has begun on schedule Auto Startup Canceled The System canceled the scheduled Auto Startup in accordance with user cancellation Auto Startup is Due Will Start at End of Run The scheduled Auto Startup will begin at the end of sample processing or hydraulic cycles Auto Startup Missed The scheduled Auto Startup was missed and did not occur while the Exerciser or System Setup tab was open Auto System Wash Exiting Standby The System moved from Standby to Ready to Run enabling the scheduled Auto System Wash Auto System Wash Canceled The System canceled the scheduled Auto System Wash in accordance with user cancellation Auto Wash Started The Auto System Wash started on schedule Auto Wash is Due Will Start at End of Run The scheduled Auto System Wash will begin at the end of sample processing or hydraulic cycles Auto Wash Missed The scheduled Auto System Wash was missed and did not occur while the Exerciser or System Setup tab was open Status Line messages 7 13 autoRETIC Reagent Empty Stop The number of consecutive occurrences of this condition has met the criterion specified for a stop message The reagent is empty and the autosampler has halted The speci
91. or 8 Normal 3 6 or 9 High RETIC 2 1 3 or 5 Low 2 4 or 6 High How many 3 5 floppy disks does it take to back up 10 000 All Complete samples It takes approximately 14 disks and 1 5 hours To save time you should do an All Complete backup every day During an All Complete the system will back up only those records that were added since the last backup The system warns you when it is almost full The default warning appears at 9800 samples and can be changed in Customer Parameters Since the system cannot operate with more than 10 000 records in the database once the database nears 9000 records you should purge the oldest 500 or 1000 records every day This will make room for the next day s samples In Customer Parameters you also have the option to set All Complete file size to trigger purge which will automatically purge records when you perform the End of Day procedure Why does the LIS link indicator on the Sample Cont Panel remain green when the host computer cable is disconnected from my PC The bi directional protocol communication link sensor is time delayed After you disconnect the cable it takes from 30 to 60 seconds for the LIS link indicator to turn red If however you attempt to send information to the host computer before this time has elapsed the indicator will turn red immediately If your system is set up for monodirectional protocol the LIS link indicator works differently After you turn on the host
92. pressing the Print Screen key when there is no printer attached to the system can cause the system to malfunction Make certain that there is a printer attached before you attempt to print the screen Welcome to the ADVIA 2120 2120i Hematology System 1 19 Results 1 20 The ADVIA 2120 21201 system can run five types of tests CBC CBC DIFF retic CBC retic and CBC DIFF retic These tests can be selected by Setting the test selectivity to default Requesting the test type from the Manual Sample ID tab Including the test type on the barcode label Including the test type in the workorder You can select a test up to the time of aspiration Once aspiration starts the system assigns the current test selectivity to the sample When aspirating samples through the manual open tube or closed tube samplers the test selected will remain the same until a different test is requested When running samples on the autosampler the selectivity will always revert back to the default setting The system alerts you to questionable results and potential system conditions in three ways Sample system flags are codes displayed in the Review Edit tab and the Run Screen These codes are associated with a specific test parameter marked by an asterisk Isolated instances of flags are usually sample related However multiple occurrences especially for consecutive samples can indicate an analyzer problem Morphology flags are plus signs display
93. properties exhibited by cell specific constituents when the cells are treated with cytochemical stains The enzyme peroxidase is present and active in several leukocyte types In the presence of hydrogen peroxide and an appropriate electron acceptor chromogen peroxidase develops a darkly colored material which precipitates in the cells Normal neutrophils and eosinophils possess significant levels of peroxidase activity with enzyme activity corresponding to cell maturation The monocytes were demonstrated to contain lower amounts of peroxidase which made it possible to define them as a cell population with relatively large light scatter signals and absorption signals that extend from the unstained cells up to and partly overlapping the most weakly stained neutrophils The lymphocyte population analyzed with the Peroxidase Method contains both lymphocytes and basophils The basophil count obtained from the Basophil Lobularity method is subtracted from the lymphocyte population to obtain the lymphocyte count The peroxidase cytochemical reaction consists of 2 steps In the first step EDTA anticoagulated whole blood sample is diluted with ADVIA 120 PEROX 1 reagent Surfactants and thermal stress cause lysis of the red blood cells Formaldehyde in ADVIA 120 PEROX 1 reagent fixes the white blood cells Regulatory Information 9 45 9 46 During the second step ADVIA 120 PEROX 2 reagent and ADVIA 120 PEROX 3 reagent are added to the peroxida
94. reset Noise BASO Stop The number of consecutive occurrences of this condition has met the criterion specified for a stop message The autosampler halts at the same time the stop message occurs The specified stop criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Stop Criteria is reset when the Start Stop button is selected Noise PEROX Alarm The number of consecutive occurrences of this condition has met the criterion specified for an alarm message The specified alarm criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Alarm Criteria is automatically reset Noise PEROX Stop The number of consecutive occurrences of this condition has met the criterion specified for a stop message The autosampler halts at the same time the stop message occurs The specified stop criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Stop Criteria is reset when the Start Stop button is selected Non WBC Interference Alarm The number of consecutive occurrences of this condition has met the criterion specified for an alarm message The specified alarm criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Alarm Criteria is automatically reset Status Line messages Non WBC Interference
95. samples the relative Baso d D is greater than 0 15 The B NV flag is triggered if the relative depth is less than 0 15 and there is no agreement between perox and baso results Normal B NV VB Flag 1 MN peak 2 PMN peak MN PMN Valley Flags Results Flagged LI Corrective Action Multiple occurrences of this flag especially for consecutive samples can indicate a system problem However isolated instances of this flag are usually sample related The following list of sample related causes may not contain all conditions that could cause this flag There is no intention to associate the flag with specific diagnoses System Related Sample Related 1 Check baso reagents e Aged blood 2 Check baso hydraulics e Absolute 3 Check the baso reaction chamber i i temperature e Immature 4 Check sheath delivery 5 Check RBC Baso Retic flowcell alignment Unsegmented neutrophils bands Baso Saturation B SAT BS Definition The Baso Saturation flag is triggered if the number of events in the Saturation area of the Baso cytogram is greater than 2 5 of the baso signals This flag is not triggered if WBCB and WBCP agree within specified limits no WBC CE flag The Saturation area of the Baso cytogram is located to the right of the fixed threshold at channel 46 above the upper MN PMN threshold 1 This area can contain air bubbles unlysed cells and cell clumps Baso Cytogram 1 Baso Satu
96. software It can automatically prepare and stain a high quality blood smear on a microscope slide for white blood cell WBC differential analysis and microscope examination The system makes and stains slides based upon criteria that you can customize in the system software You can also choose to have slide making occur on all slides or no slides and you have the option for slides to be prepared but not stained IMPORTANT The system produces slides for samples aspirated in the autosampler mode only 1 Slide dispenser 2 Broken slide tray 3 Front access door 4 Rack loader 10 2 5 Manual STAT inlet door 6 Stain overflow collection tray 7 Rack collection area 8 Stainer access door ADVIA Autoslide Slide Maker Stainer Slide dispenser AN WARNING Do not try to empty the slide dispenser Finger injuries may occur if slides are removed from the slide dispenser assembly Avoid any unnecessary contact with the slide dispenser mechanical device The slide dispenser cover cannot be removed without using a tool Do not disable the sensors Broken slide tray LN wanne BIOHAZARD All sharp objects such as broken slides should be considered biohazardous and disposed of in an appropriate container To avoid personal injury handle broken slides with care Wear personal protective equipment Use universal caution For complete biohazard statement refer to section on Autoslide Safety Information and Warnings Front access door
97. surfactant that lyses the red cells platelets and the cytoplasm of all white cell types except basophils ADVIA 2120 2120 SHEATH RINSE NOTE For more detailed information on the contents of ADVIA 2120 21201 SHEATH RINSE please see Chapter 8 ADVIA 2120 21201 SHEATH RINSE has several important functions Optical sheath for Baso RBC Platelet and Reticulocyte Methods e Constricts the sample stream so that only one cell at a time can pass through the viewing area 8 3 8 4 e Prevents contact between the sample stream and the flowcell walls which prevents clogs and staining of the flowcell e Provides an optically transparent medium through which the sample stream can be clearly focused Rinse for Baso RBC Platelet Peroxidase Reticulocyte and Hemoglobin Methods e Cleans the hydraulic pathways for each method Baseline solution for Hemoglobin Method e Provides a baseline reading Measurement A constant volume of the cell suspension from the baso reaction chamber passes through the flowcell where the low angle light scatter 2 3 and high angle light scatter 5 15 signatures of each white blood cell are measured based on e The size of the cell or nucleus e nuclear configuration which is a combination of the nuclear shape and cell density ADVIA 2120 21201 SHEATH RINSE encases the sample stream as the two fluids pass through the flowcell The optical signals from the flowcell are con
98. the Log On Off window 2 Select CTRL ALT DELETE and log back onto the system to restart the software If the problem persists call Siemens Service for assistance Initialization Failed During Image Download Software communication error Corrective Action Follow these steps to exit the ADVIA 2120 2120i software and then restart 1 Select Shut Down ADVIA at the Log On Off window 2 Select CTRL ALT DELETE and log back onto the system to restart the software If the problem persists call Siemens Service for assistance Initialization Failed During OMF File Download Software communication error Corrective Action Follow these steps to exit the ADVIA 2120 2120i software and then restart 1 Select Shut Down ADVIA at the Log On Off window 2 Select CTRL ALT DELETE and log back onto the system to restart the software If the problem persists call Siemens Service for assistance Initialization Failed Waiting for Waste and Rinse Clear During System Preparation in Progress the SHEATH RINSE was empty or the waste container was full Possible Cause Corrective Action 1 SHEATH RIN Replace the SHEATH RINSE reagent The system SE empty preparation process will continue automatically during System Preparation 2 Waste Empty the waste container and replace The system container full preparation process will continue automatically during System Preparation Status Line messages 7 55 7 56 Initialization Failed Writing I
99. the manual and autosampler modes Check to ensure that there are no leaks and that fluid passes through the filters properly Make sure that the lines do not interfere with autosampler aspirator motion TO COUPLER PLATE FITTING PN 518 0695 03 FITTING DIRECTION PN 518 0695 13 OF FLOW TO CENTERING COLLAR OR MANUAL SAMPLER 5 28 Troubleshooting the Analyzer Replacing a Perox Check Valve Time Installation and Checkout 15 minutes Materials required Check valve PN 556 1190 01 Analyzer mode Standby BIOHAZARD All products or objects that come in contact with human or animal body fluids should be handled before and after cleaning as if capable of transmitting infectious diseases Wear facial protection gloves and protective clothing The operator should follow the recommendations to prevent the transmission of infectious agents in health care settings as recommended for potentially infectious specimens in Protection of Laboratory Workers from Infectious Disease Transmitted by Blood Body Fluids and Tissue 2nd edition Approved Guideline 1997 Document M29 A National Committee for Clinical Laboratory Standards NCCLS This document contains complete information on user protection and it can be used as reference material for instructions on laboratory safety 1 Remove the old check valve from the Perox line 2 Install the check valve into the line with the direction of flow toward the reagent pump and away f
100. the nRBCs from lymphocytes Flags 6 49 6 50 NRBC Enumeration Histogram Noise Lymph Histogram Legend Unstained Events Suspect Large Plt Interference NRLPLT NP The Suspect Large Plt Interference flag is triggered if the system counts more than 40 000 large platelets uL in the RBC PLT channel Results Flagged NRBC NRBC WBC NEUT NEUT LYMPH LYMPH MONO MONO EOS EOS BASO BASO LUC LUC NRBC Enumeration Histogram Large platelets may obscure the nRBC TAT population as shown to the left Unstained Events NRBC Re Lymph Events Suspect Lipid Interference NR LPD NL Definition The Suspect Lipid Interference flag is triggered if the number of signals in the noise region of the Basophil Lobularity Channel exceeds a specified limit when the system reports an NRBC count The NR LPD flag is triggered when both of the following conditions occur BASO Noise gt 2 e BASO Noise x WBCB gt 10 Flags Results Flagged NRBC NRBC WBC NEUT NEUT LYMPH LYMPH MONO MONO EOS EOS BASO BASO LUC LUC The Baso cytogram and NRBC Enumeration Histogram below illustrate the NR LPD flag The circled area of the Baso cytogram identifies the lipid pattern Baso Cytogram NRBC Enumeration Histogram Legend Unstained Events Lymph Events WBC Substitution WBCSUB WS The WBC substitution rules for CBC DIFF samples are as follows WBCB is reported as the
101. the percentage of the cells with hemoglobin concentrations less than 28 g dL Normochromic region N Hyperchromic region 28 g dL marker 41 g dL marker a RBC HC histogram hyperchromic sample Hypochromic region Normochromic region Hyperchromic region 28 g dL marker 41 g dL marker A WN 2 Methods Methods In samples with increased numbers of hyperchromic RBCs the histogram curve shifts to the right indicating an increase in the percentage of the cells with hemoglobin concentrations greater than 41 g dL RBC HC histogram Hgb variance sample Hypochromic region Normochromic region Hyperchromic region 28 g dL marker 41 g dL marker a amp N HDW provides an indication of Hgb concentration variance and the results are flagged if the HDW exceeds 3 4 g dL Note that two specimens with the same HDW value can have different degrees of hypochromia and hyperchromia RBC CH Histogram The RBC CH cellular hemoglobin histogram represents the distribution of red blood cells by the amount of hemoglobin present in each cell independent of cell volume The histogram has a range of 0 picograms to 100 picograms Cellular Hemoglobin Content CH is the mean of the RBC CH histogram The cell hemoglobin distribution width CHDW is the standard deviation of the RBC CH histogram RBC Scatter Cytogram The RBC Scatter cytogram is the graphical representation of two light
102. the regulator if gauge is outof necessary Tange Setpoint 40 PSI 2 2 Pressure leak Check for crimped or disconnected hydraulic or pneumatic lines Straighten or reconnect lines as necessary IMPORTANT If problems persist Call Siemens Service for assistance Further corrective action must be taken by Siemens service personnel only Status Line messages 7 5 7 6 5 PSI Out of Range System pressure is out of range Possible Cause Corrective Action 1 5 PSI pressure Check the 5 PSI gauge and adjust the regulator if gauge is outof necessary range Setpoint 5 PSI 0 5 2 Pressure leak Check for crimped or disconnected hydraulic or pneumatic lines Straighten or reconnect lines as necessary 5 PSI Out of Range Stop System pressure is out of range The system has stopped because the pressure has reached a critical level that may affect the integrity of sample results and damage the system Possible Cause Corrective Action 1 5 PSI pressure Check the 5 PSI gauge and adjust the regulator if gauge is out of necessary range Setpoint 5 PSI 0 5 2 Pressure leak Check for crimped or disconnected hydraulic or pneumatic lines Straighten or reconnect lines as necessary IMPORTANT If problems persist Call Siemens Service for assistance Further corrective action must be taken by Siemens service personnel only 80 Conflict A conflict has occurred on a sample that was accessed by two different tasks for example Re
103. thresholds in the Retic Scatter Abs cytogram excluding channel 99 Neg RBC The number of cells in the mature RBC area 1 of the Retic Scatter Abs cytogram Neg RBC Count of mature red blood cells Neg RBC Percent of mature red blood cells 8 69 8 70 Number of Reticulocytes in the gated population The total number of cells in the three reticulocyte areas of the Retic Scatter Abs cytogram Retic Count Count of reticulocytes in the gated population Number of Low Absorption Reticulocytes The number of gated cells 1 between the RTC and Low Medium RTC thresholds of the Retic Scatter Abs cytogram LRetic Count of low absorption reticulocytes LRetic Percent of low absorption reticulocytes Number of Medium Absorption Reticulocytes The number of gated cells 1 between the Low Medium RTC and Medium High RTC thresholds of the Retic Scatter Abs cytogram MRetic Count of medium absorption reticulocytes Methods Methods cMRetic Percent of medium absorption reticulocytes Number of High Absorption Reticulocytes The number of gated cells 1 to the right of the Medium High RTC threshold of the Retic Scatter Abs cytogram HRetic Count of high absorption reticulocytes HRetic Percent of high absorption reticulocytes 8 71 8 72 Methods Regulatory Information METHODS INTRODUCTION csccssssssssssssessssrsessessssesscssssessessssessessssessessssessessesese
104. tipped swab into EZ KLEEN wipe clean the inside of the perox chamber AN CAUTION To avoid pushing any dirt into the drain and reagent ports at the base and back wall of the chamber always wipe the chamber by starting at the bottom of the back wall using a circular up and outward motion Using a 2 mm disposable pipette fill the chamber 1 3 full with EZ KLEEN Using the pipette agitate the liquid in the chamber then let it soak for one minute Agitate the liquid again Then using the pipette remove all the liquid from the chamber Check if there are any black particles in the liquid If yes repeat steps 3 through 6 until the EZ KLEEN is clear when you remove it from the chamber Using the dental mirror and flashlight check that the chamber is clean If it is not clean repeat steps 3 through 6 Replace the perox chamber cap Perform a System Wash Cleaning the Autosampler Rinse to Waste Line V45 Pathway Materials required Beaker Deionized water Troubleshooting the Analyzer Household bleach Time 4 minutes Analyzer mode Ready to Run 1 2 M Open the front cover At the Utilities menu select the Exerciser tab and select the Valves button on the left Remove the tubing from the V45 nipple on the autosampler centering collar Place the end of the tube into a beaker of 25 solution of household bleach and water At the Exerciser select V45 to open the valve Aspi
105. to collect data reflecting the patient s chemical hematological or immunological status at certain point in time Such data must be used in conjunction with other diagnostic information and with the attending physician s evaluation of the patient s condition to arrive at a diagnosis and a clinical course of treatment Any malfunction of a Siemens diagnostic product for example failure to meet a performance specification or to perform as intended should be appropriately addressed by laboratory personnel Various sections of the Product Labeling address malfunctions and their possible effect on results Explanation of the warning labels on the AC power box B 10 1 The AC power box must be opened by qualified personnel only The only operator serviceable parts in the AC 2 power box are fuses F1 through F7 which are replaced without opening the module 2 The two electrical outlets on the side of the AC power box are intended only for the computer and monitor supplied with the system These outlets are designed to ensure proper operation of the system devices and to maintain the system safety AC power box location certifications Do not connect other devices to them 3 Since electrical power is still applied to some system components even after the power switch is turned off you must unplug the main power before servicing the system for example when replacing fuses 4 Always replace fuses F1 and F2 at the same tim
106. to open the manual inlet door door and try again Autoslide operation Warning Instrument is in standby so Take instrument out of Standby mode cannot proceed as compressor is off Compressor is Not Ready Autoslide Rejects Warning The Autoslide is unable to execute Action depends on the situation Command Execution the command at this time Generally no action is required Autoslide Weekly Warning An error occurred during the Check message log for other errors Shutdown Incomplete weekly shutdown correct problem reset Autoslide and repeat weekly shutdown Autoslide Weekly Startup Warning An error occurred during the Check message log for other errors Incomplete weekly startup correct problem reset Autoslide and repeat weekly startup Autoslide Weekly Startup Warning Weekly startup is now required Perform weekly startup Needed ADVIA Autoslide Slide Maker Stainer 10 51 Autoslide Specifications The Autoslide is for indoor use only Operation of the instrument at altitudes of over 2000 meters 6000 feet is not recommended Throughput Up to 108 slides per hour Dimensions Weight 60 kg approx Width 91 cm Depth 70 cm Height 50 cm Operating Temperature Range 20 30 C Relative Humidity 30 60 Noise Level 65 decibels Electrical Requirements From 100V to 240V 10 Maximum 200 VA Slide Requirements super frost rounded corner ground edges 76 mm x 26 mm x 1 mm Use slides prov
107. using a hemocytometer and phase contrast microscopy The macro dilution for Plt is 1 125 using 1 ammonium oxalate as the diluent The reference hemoglobin method is performed using the NCCLS H 15A approved standard method with ICSH traceable certified hemoglobin standards The reference microhematocrit is performed using NCCLS H 7A approved standard method with tripotassium EDTA as the anticoagulant The System Specific Target Values SSV are assigned for ADVIA 120 SETpoint Hematology Calibrator and ADVIA 120 TESTpoint Hematology Control products by assaying each lot on an ADVIA 2120 2120i Hematology System that was calibrated using fresh normal whole blood samples that were assigned RBC WBC Plt Hct and Hgb values using the methods described above Regulatory Information 9 7 REF 02337140 01554628 REF 05101601 REF 09119084 9 8 ADVIA 120 OPTIpoint values are assigned using an ADVIA 2120 2120i Hematology System after standardizing the system with three reference oils The index of refraction for each oil is determined with a refractometer that is calibrated using NIST standards The index of refraction is measured at the wavelength of the ADVIA 2120 21201 system s laser as a function of temperature During OPTIpoint value assignment the temperature of the effluent is monitored so the correct index of refraction can be used to standardize the ADVIA 2120 21201 system When stored at 2 C to 8 C unopened ADVIA OPTIpoint
108. uve 65 BIBLIOGRADPHY 5 rhe dive eei ie o 66 CALCULATING RETIC PARAMETERS 66 Methods Basophil Lobularity Method Methods Cytochemical Reactions The basophil lobularity cytochemical reactions consist of two steps Step 1 Red blood cells and platelets are lysed using the ADVIA 2120 2120i BASO reagent Step 2 All white blood cells except basophils are stripped of their cytoplasm using the ADVIA 2120 21201 BASO reagent and the increased temperature the reaction chamber The stripped white cells can now be categorized as mononuclear or polymorphonuclear cells based on the shape and complexity of their cell nuclei The intact basophils can be easily distinguished from the smaller cell nuclei Basophil Lobularity Temperature Control Temperature control is critical to the cell stripping process The baso reaction chamber temperature which is automatically monitored by the analyzer must be between 32 C and 34 C If you want to check the baso reaction chamber temperature At the Utilities menu select Analyzer Status If you need to adjust the baso reaction chamber temperature 1 Atthe Special Procedures menu select Adjust Lamp Temp 2 Select Baso Temperature ADVIA 2120 2120 BASO Reagent NOTE For more detailed information on the contents of ADVIA 2120 21201 BASO reagent please see Chapter 8 The ADVIA 2120 2120 BASO reagent contains phthalic acid and a
109. volume and hemoglobin concentration of individual red cells by laser light scattering Blood 68 506 513 1986 Reagents The following ready to use reagents are required to perform the CBC method and maintain the ADVIA 2120 21201 Hematology System You must use either the CBC TIMEPAC or the CN FREE CBC TIMEPAC along with the SHEATH RINSE ADVIA 120 CBC TIMEPAC Product Number Symbol Contents Amount mL T01 3620 52 CBC TIMEPAC T01 3625 01 DEFOAMER 1 x 75 mL T01 3627 01 RBC PLT 2 x 2700 mL T01 3628 01 2x 1100 mL 01 3629 01 BASO 2 x 1100 mL ADVIA 120 CN FREE CBC TIMEPAC Product Number Symbol Contents Amount mL T01 3626 52 CN FREE CBC TIMEPAC T01 3625 01 DEFOAMER DEFOAMER 1 x 75 mL Regulatory Information 9 23 REF Product Number Symbol Contents Amount mL T01 3627 01 RBC PLT 2 x 2700 mL T01 3629 01 BASO 2x 1100 mL 01 4288 01 2 1100 mL ADVIA 120 SHEATH RINSE REF Product Number Symbol Contents Amount L 02337140 01 3664 01 SHEATH RINSE 101 01554628 01 3623 01 SHEATH RINSE 201 ADVIA 120 DEFOAMER PN T01 3625 01 1 x 75 mL ADVIA 120 DEFOAMER contains Silicone emulsion 10046 Shake before use For in vitro diagnostic use ADVIA 120 RBC PLT PN T01 3627 01 2 x 2700 mL ADVIA 120 RBC PLT contains Sodium dodecyl sulfate 0 035 mmol L Disodium EDTA dihydrate 4 03 mmol L Tetrasodium EDTA dihydrate 3 36 mmol L Sodium chloride 109 3 mmol L Glutaraldehy
110. 0 RBC PLT reagent are stable for 45 days Protect product from freezing When stored at 2 C to 8 C unopened ADVIA OPTIpoint PN T03 3682 01 ADVIA SETpoint Calibrator PN T03 3685 01 and ADVIA TESTpoint Hematology Controls PN T03 3686 01 Low T03 3687 01 Normal and T03 3688 01 High respectively are stable until the last day of the month of the expiration date printed on the product label unless stated otherwise After being opened ADVIA OPTIpoint is stable for 7 days ADVIA TESTpoint Hematology Controls are stable for 10 days and the ADVIA SETpoint Calibrator is stable for 5 days when stored closed in their original containers at 2 C to 8 C Gain Adjustment The gain adjustment procedure is used to adjust the amplification signals in a channel to properly position the cell signatures within a cytogram Calibration The system must be calibrated for all parameters except Siemens recommends the use of the ADVIA SETpoint Calibrator PN T03 3685 01 Calibration procedure should be performed e Upon installation of the system e If there is a significant shift in control values after the replacement of a critical hardware component or reagent lot after checking gains e Anytime control results and or moving averages are out of range and it has been verified that the out of control condition is instrument related Regulatory Information Sample Handling Sample Collection Collect whole blood in an evac
111. 00000 0000000000000000000000 39 REPLACING THE RBC BASO RETIC FLOWCELL 42 REPLACING THE SYRINGES ccccessessscecececeesssaececececsensaaececececeeseaaeceeececeeseausaeseeeeseneaaees 45 REPLACING THE VACUUM PUMP FILTER 8 2 2 40 00000 00000000 000 45 REPLACING THE WASH 2 0000000 000 0000000000000000000 47 TROUBLESHOOTING 8 AUTOSAMPLER TROUBLESHOOTING 8 49 CANNOT FIND VIDEOS 5 5 ERE 49 CHECKING DRAIN FILTERS FOR 49 COMPRESSOR DOES NOT 5 0 000420 0 00 0000 49 DATA MANAGER AND 1 8 0 2002022 0 20000000000000000000 50 NO SOUND WHEN VIEWING VIDEOS 2 50 PEROX CHAMBER 51 Troubleshooting the Analyzer 5 1 If you are unable to correct a problem and require service assistance please contact your local technical support provider or distributor Alignments and Adjustments 5 2 Adjusting the Hgb Baseline Value When to adjust the Hgb colorimeter lamp baseline value e After replacing the lamp e If the baseline value is gt 4 2 volts e If indicated during troubleshooting To adjust the Hgb baseline value 1 At the Procedures menu select the Adjust Lamp Temp tab 2 Select Hgb Baseline 3 Pop out the small white plug on the colorimeter to a
112. 20 autoRETIC contains Oxazine 750 11 4 mg L Buffer N Tetradecyl N N dimethyl 3 ammonio 1 propane sulfonate 0 023 mmol L N N dimethylformamide 0 38 For in vitro diagnostic use Regulatory Information 9 55 REF 05101601 REF 09091295 REF 08773805 9 56 ADVIA 120 EZ KLEEN Product Number Symbol Contents 01 3624 54 EZ KLEEN EZ KLEEN T01 3624 01 EZ KLEEN As formulated contains Sodium hydroxide 50 mmol L 2 2 Ethoxyethoxy ethanol 894 mmol L Surfactant For in vitro diagnostic use Amount mL 4x 810 mL 810 mL For a product description of SHEATH RINSE please refer to page 25 For a product description of DEFOAMER please refer to page 24 Storage and Stability Reagents When stored between 15 C and 30 C e All unopened reagents are stable until the expiration date printed on the product label Opened containers of the ADVIA 120 autoRETIC reagent are stable for 120 days e Opened containers of ADVIA 120 SHEATH RINSE are stable for 45 days e Opened containers of ADVIA 120 EZ KLEEN and DEFOAMER are stable for 90 days Calibrators and Controls ADVIA 120 RETIC Control High Product Number Symbol Contents T03 3691 54 cowmo nenc we Reticulocyte Control High T03 3691 01 conmo Hematology Control High ADVIA 120 RETIC Control Low Product Number Symbol Contents T03 3690 54 cono Reticulocyte Control Low Amount m
113. 3 9 44 CSF RBC Low Level Linearity Pool Observed Expected of reference level RBC RBC 0 00 0 0 0 05 2 1 0 1 4 3 0 2 9 6 1 0 34 29 10 0 308 288 100 reference level 2880 2880 Absolute Deviation Deviation 0 1 1 3 5 20 0 7 0 NOTE Although RBC linearity has been demonstrated up to 2880 RBC uL samples with greater than 1500 RBC uL should be diluted to ensure the accuracy of the white count Regulatory Information WBC DIFF Method Intended Use The ADVIA 2120 2120i Hematology System White Blood Cell Differential WBC DIFF methods consisting of both the Peroxidase method and the Basophil Lobularity method are intended to quantitatively measure the following WBC hematological parameters Neutrophils percentage of WBC NEUT and absolute count Lymphocytes percentage of WBC and absolute count LY MPH Monocytes percentage of WBC 7 MONO and absolute count Eosinophils percentage of WBC 96EOS and absolute count EOS Large Unstained Cells percentage of WBC LUC and absolute count LUC Basophils percentage of WBC BASO and absolute count BASO Principles of the Procedure Peroxidase Method The peroxidase method was developed by Cremins Kim Malin and Sclafani based on the principles of differential cellular staining outlined by Ansley and Ornstein According to these principles leukocytes are classified by the characteristic
114. 4 hours when stored at 18 C 30 C Prepared CSF patient samples and prepared ADVIA 120 TESTpoint CSF controls contain 1 and 1 5 formaldehyde respectively These should be disposed of according to local environmental regulations Sample and Control Preparation Use the following procedure to prepare CSF samples or control products for analysis on the ADVIA 2120 2120i Hematology System NOTE The CSF Assay requires a CSF sample volume of 300 uL Reserve sufficient sample volume for slide preparation or additional analysis if necessary Samples with high RBC counts may require dilution prior to preparation with CSF Reagent Phosphate buffered saline PBS is the preferred diluent for these samples although normal saline may be also used Samples diluted in normal saline should be prepared with CSF reagent immediately after dilution and will require a longer incubation period than undiluted samples or samples diluted in PBS 1 Add 300 uL of thoroughly mixed CSF sample patient or control to 300 uL of CSF Reagent in a labeled glass or plastic test tube 2 Cap and mix the prepared sample by gently inverting it 5 10 times or vortexing for 5 seconds Care should be taken to avoid foaming 3 Incubate it at room temperature for at least 4 minutes Samples should be assayed within 4 hours of preparation 4 After preparing the sample replace the reagent cap and return any quality control materials to refrigerated storage 5 After
115. 598 7 Jl gt Both main fuses F1 and F2 must be replaced if either one is blown Location Two main fuses F1 and F2 1 fuses F3 through F7 2 N Analyzer mode Off power cord unplugged To replace the 20 mm fuses F3 through F7 1 Loosen the fuse holder by turning it counterclockwise 2 Pull out the fuse holder then remove the faulty fuse 3 Insert the new fuse slide the fuse holder in and tighten it by turning it clockwise 4 Plugin the power cord and set the power switch to I on To replace main fuses F1 and F2 NOTE Both fuses must be replaced 1 With a screwdriver loosen the fuse cap by turning it counterclockwise Troubleshooting the Analyzer 2 Remove the fuse cap and replace the fuse 3 Install the fuse cap and tighten it by turning it clockwise 4 Plug in the power cord and set the power switch to I on Replacing the Hemoglobin Colorimeter Lamp When to replace the lamp e If there is an HGB PL error e If it is burned out e If the baseline value falls below 2 5 If the baseline value cannot be adjusted T to between 3 0 and 4 1 volts E If indicated during troubleshooting prm When to adjust the baseline value e After replacing the lamp e Ifthe baseline value is 24 2 volts e If indicated during troubleshooting AN WARNING Avoid burns Allow enough time for the hemoglobin lamp to cool After power is shu
116. 6 RETIC RBC COUNT LOW RTC L CL eene enne 47 RETIC SATURATION RTCS AT O 2 5 eet Ier ie 47 6 1 6 2 RETIC SLOPE ERROR RTC SE SE esses eee enne nennen 48 SUSPECT CELLULAR INTERFERENCE NRCELL 49 SUSPECT LARGE PLT INTERFERENCE NRLPLT 50 SUSPECT LIPID INTERFERENCE 50 WBC SUBSTITUTION WBCSUB WS 51 Flags Morphology Flags Flag ANISO ATYP BLASTS HCVAR HYPER HYPO IG Flags Summary Laboratory personnel are alerted to suspected sample abnormalities through the combined use of morphology and quantitative flags high and low ADVIA 2120 2120 morphology flags are derived from a series of complex algorithms These algorithms are based on the identification of conditions surrounding the presence of abnormalities For a description of result rounding please see Calculation of Results in the Regulatory Information Section of this manual The ADVIA 2120 2120i system does not enumerate abnormal cells Despite a high degree of sensitivity and specificity in detecting conditions consistent with the presence of abnormal cells test results produced by the ADVIA 2120 2120i system are intended for laboratory use only Whenever morphology or quantitative flags are triggered the laboratory before reporting patient results must validate the results and take the appr
117. 632 54 6 0 088 96 Mono 9 5 17 6 0 15 96 Performance Characteristics Carryover Because of the low number of cells counted in CSF analysis the ADVIA 120 hydraulic cycles were designed to eliminate carryover when assaying CSF samples Prior to assaying each CSF sample the ADVIA120 rinses all reagent and sample pathways in preparation for the next sample Carryover for the CSF Assay was evaluated by measuring multiple assays of a highly cellular sample followed by a low cellular sample The observed carryover was less than 1 where carryover is expressed as the average percentage of the high level sample that is lost to the trailing low level sample Performance Characteristics Analytical Range The analytical range for CSF WBC and RBC counts was established by making serial dilutions of samples prepared to have low analyte values The dilution studies show that the CSF WBC count is accurate to 5 cells uL over the range 0 50 cells uL and accurate to 10 over the range 50 5 000 cells uL The CSF RBC count is accurate to 5 cells uL over the range 0 50 cells uL and accurate to 10 over the range 50 2880 cells uL The results from the study are found in the tables below CSF WBC Low Level Linearity Pool Observed Expected Absolute of reference level WBC WBC Deviation Deviation 0 00 0 0 0 0 05 2 3 1 0 1 5 5 0 0 2 10 10 0 1 0 53 50 3 10 0 514 501 13 3 100 reference level 5009 5009 0 0 Regulatory Information 9 4
118. ADVIA 2120 ADVIA 2120i Hematology Systems ADVIA 2120 2120i Hematology Systems Operator s Guide 067D0157 01 Rev C 2010 04 SIEMENS 2010 Siemens Healthcare Diagnostics Inc All rights reserved No part of this operator s guide or the products it describes may be reproduced by any means or in any form without prior consent in writing from Siemens Healthcare Diagnostics ADVIA OPTIpoint and TIMEPAC are registered trademarks of Siemens Healthcare Diagnostics Acrobat is a trademark of Adobe Systems Incorporated Carbon Copy is a trademark of Altiris Clorox is a trademark of the Clorox Co Exetainer is a trademark of Labco Ltd HEWLETT is a trademark of Hewlett Packard Company HEMOGARD and VACUTAINER are trademarks of Becton Dickinson Corporation Intel and Pentium are trademarks of Intel Corporation Loctite is a trademark of Loctite Corporation Lysol is a trademark of National Laboratories Microsoft Windows NT and Windows are trademarks of Microsoft Corporation Monoject is a product of Sherwood Medical Monovette is a trademark of Sarstedt Incorporated Nokia is a trademark of Nokia Corporation Tapval is a trademark of Aquisel S L Teflon is a trademark of E I DuPont de Nemours Vacuette is a trademark of C A Greiner amp S hne Venoject is a trademark of Terumo Medical Zip is a trademark of Iomega Corporation Origin Ireland Siemens Healthcare Diagnostics Inc Tarrytown NY 10591
119. APPLY TO CUSTOMERS IN THOSE JURISDICTIONS OR SUBJECT TO THOSE AGREEMENTS Information for Technical Assistance Refer to the procedures in this appendix to provide system information that you may need when you call for technical assistance Contact Information This section provides the following information address of the Siemens authorized representative which is the Siemens contact within the European community Siemens addresses for obtaining service and technical information and for ordering supplies Siemens Authorized Representative Siemens Healthcare Diagnostics Ltd Sir William Siemens Sq Frimley Camberley UK GU16 8QD Legal Information A 5 Addresses For technical assistance contact your local technical support provider For customer service or additional information contact your local technical support distributor Siemens Healthcare Diagnostics Inc Tarrytown NY 10591 5097 USA Siemens Healthcare Diagnostics Ltd Sir William Siemens Sq Frimley Camberley UK GU16 80D www siemens com diagnostics Siemens Healthcare Diagnostics Pty Ltd 885 Mountain Highway Bayswater Victoria 3153 Australia Y XYAAWATP 4 PARAS 3 20 14 Siemens Healthcare Diagnostics CEN Legal Information Warnings and Safety Information WARNINGS 2 SAFETY INFORMATION 8sisccisssccscsscscseccsssssessscssscssesscsoesesccessessosssccise
120. AUTION To avoid getting fingerprints on the glass windows of the flowcell always hold the flowcell by the metal slides 5 44 Troubleshooting the Analyzer To install the flowcell 1 Hold the flowcell by its red threaded fitting and place it gently into the optics assembly 2 Place the flowcell onto the guide pins Make sure that it is resting on both pins The flowcell will be at a 4 angle Tighten the captive flowcell release screw to lock the flowcell into position 3 Reconnect the hydraulic lines to the CFM Reconnect the flowcell tube assembly fitting to the appropriate hydraulic valve V234 Hand tighten the connection enough to prevent leaks IMPORTANT To avoid incorrect patient data make sure that each hydraulic line is attached to the correct CFM nipple To check analyzer performance 1 2 Bring the analyzer to the Ready to Run mode then run a saline primer Check the flowcell connections for leaks and verify saline background on the Startup tab At the Procedures menu select the Align Optics tab Select the Info button for help At the Logs menu select Cal Gain Logs and check gain factors Adjust gains if necessary Run a whole blood primer and then run controls to verify analyzer performance If the control results are acceptable to the laboratory no additional action is required and normal operation can be resumed Replacing the syringes To remove and replace one of the syringes follow instr
121. Action 1 Autosampler Using Exerciser tab calibrate Car Index position CPU board Mixer Shuttle position and Mixer Aspirate position contains new unprogrammed flash memory Flash memory Using Exerciser tab calibrate Car Index position has lost the Mixer Shuttle position and Mixer Aspirate position stored values Autosampler Car Alignment Error Reset Autosampler The autosampler car is out of alignment A reset is required Corrective Action 1 2 3 Open the autosampler access door Close the autosampler access door The autosampler resets If the problem persists call Siemens Service for assistance Autosampler Car Initialization Failed Reset Autosampler The autosampler car has failed to initialize properly A reset is required Corrective Action 1 2 3 4 5 Open the autosampler access door Close the autosampler access door The autosampler will reset If the problem persists press the Off button on the analyzer touchpad Wait about minute and press the On button to restart the analyzer If the problem persists call Siemens Service for assistance Autosampler Car Lost Steps Reset Autosampler The autosampler car is not in the expected position A reset is required 7 16 Status Line messages Possible Cause 1 Car movement problem 2 Persistent car movement problem causing binding and excessive drag on the racks Corrective Action On the analyzer touchpad select Off
122. All analyzer waste is stored in an 11 liter waste container When the fluid level in the container reaches the Maximum Level line approximately 8 liters an error message appears on the monitor and an audible alarm is sounded The system will not aspirate any more samples until the waste container is emptied Manual Waste Removal CAUTION Make sure all cycles are completed before disconnecting the waste container N The waste container must be connected to the system when any system cycles are in progress including the system startup cycle If the waste container is not connected fluid will back up into the UFC and damage the system 1 Make sure that the analyzer is not sampling 2 Ifa message requesting a rinse or a wash displays select Cancel 3 Disconnect the waste line 1 and the vacuum line 2 To do this select the buttons 3 on the quick release connectors as you pull the lines straight up 4 Disconnect the level switch sensor connector 4 by selecting its button 5 Replace the full container with an empty one and connect the waste and vacuum lines and level sensor to the new container CAUTION Do not open the waste container cap If the cap is loosened or not replaced N correctly sufficient operating vacuum cannot be reached 3 2 Daily Routine 6 Empty the full container by opening the spigot 5 into a drain that is capable of accommodating a flow rate of approximately five liters per minu
123. An autosampler reset is required Possible Cause Corrective Action 1 Rack has a Remove and replace rack jammed the b Select Start on the analyzer touchpad The y p leading edge autosampler resumes operation of the input queue blade If the autosampler does not start Select Off at the analyzer touchpad b Wait about 1 minute and select On to restart the analyzer c Ifthe problem persists call Siemens Service for assistance 2 Queue pan Check the queue pan for foreign objects cannot move properly 3 Feed motor Call Siemens Service for assistance has failed Status Line messages Autosampler Input Shuttle Blocked A rack in the input shuttle position is preventing the autosampler from completing a movement Corrective Action 1 Remove the rack from the shuttle position at the front of the input queue 2 Select Start at the analyzer touchpad to restart autosampler operation Autosampler Input Shuttle Not Empty A rack in the input shuttle position is preventing the autosampler from completing a movement Corrective Action 1 Remove the rack from the shuttle position at the front of the input queue 2 Select Start at the analyzer touchpad to restart autosampler operation Autosampler Internal Communication Failure During normal operation the autosampler detected an internal software level communication failure This caused the autosampler to stop operation Corrective Action 1 At the analyzer touchpad select Off
124. BC7 PLEL uie ee et RE Rass ee 37 2 38 MEASUREMENT RBC 1 2 0020 020 0100000000000000000 38 MEASUREMENT PLATELET 0 0 0000000 000000000000 nn nne tn nnns 38 39 Methods 8 1 8 2 5 40 RBC VOLUME 5 20000000000000000000000000 40 ie iei ee Ee evt 42 RBCCH HISTOGRAM VER REI EE 43 RBC SCATTER CYTOGRAM 43 RBC VOLUME HEMOGLOBIN V HC CYTOGRAM 2 112004 00001 44 pe eR V AS S TE EE EE REEE va VER 45 PLATELET X HISTOGRAM Dye tot PEERS e eoa UR HI VEREOR E WO ve AR 46 PEATELET Y HISTOGRAM erecta desee estes pete et cii ue venice aves 46 PLATELET VOL 5 200 00000 0010100000000000000000 00 46 PEATELET PC HISTOGRAM 025 20 47 PLT SCATTER CYTOGRAM 2 e Ee eie e e EAE RE aE e PE Reed 47 202004 48 INTEGRATED ANALYSIS
125. Clean the centering collar Make sure that you remove all buildup at the mating surface 3 of the centering collar and the assembly Allow to stand for 5 minutes then wipe the assembly dry with paper towels and cotton swabs Repeat if necessary Reposition the assembly Make sure that it drops firmly into place then reconnect the sample line AN CAUTION After repositioning the aspirator assembly finger tighten the thumb screws being careful that they are not cross threaded Overtightening of the screws can warp the baseplate which will cause misalignment of the sampler Mis threading the thumb screws can cause needle damage Place the tubing going to the centering collar into the hook on the side of the IDee reader 4 21 Troubleshooting the Analyzer ALIGNMENTS AND 0000 2 ADJUSTING THE HGB BASELINE 12 2 00000 0010000000000000 2 ADJUSTING THE LENGTH OF THE SAMPLE 3 ADJUSTING THE PNEUMATIC REGULATORS 2 MAXIMIZING THE PEROX LAMP OUTPUT REPROGRAMMING THE MANUAL BARCODE READER 22 222 5 CLEANING PROCEDUREG csssssssssssssscscssssscscnsesesscnsesceseeesesssnessssessessesessersssesses BACKFLUSHING THE DRAIN FILTERS cscsessecececeesesssaececececsessaececececsensaeeecececeenenaees 5 CLEANIN
126. Criteria 1 Difference between mean and mode RETIC Abs Histogram gt 15 2 Chi square error for the Gaussian fit gt 80 000 Noise Origin gt 10 of gated cells Cells analyzed lt 10 000 CV for RETIC Abs Flatness histogram gt 3 6 Saturation cells gt 10 of gated cells Slope of negative cell population on absorption axis gt 0 2 1 WBCB WBCP gt 1 0 x 105 uL when WBCB gt 2 0 x 10 uL and 10 0 x 105 uL 2 WBCB WBCP gt 10 of WBCB when WBCB 210 0 x 105 uL 3 WBCB WBCP gt 20 WBCB when WBCB 2 0x 105 uL 4 WBCB count is not flagged if the PX NV or PX NO flags are set If WBCB is flagged but WBCP is not the WBCP value is reported If both WBCB and WBCP are flagged WBCB is reported If WBCB 1000 cells uL WBCB is reported with an asterisk CBC CBC v CBC DIFF DIFF RETIC CBC RETIC v RETIC Flags Flags Baso Count Suspect B SUSP BC Definition The Baso Count Suspect flag is triggered if the percentage of events acquired in the region of the Baso cytogram located above the upper MN PMN threshold and between channels 0 and 49 on the x axis exceeds 5 0 When cluster analysis is applied the Baso Count Suspect region of the Baso cytogram is located above the upper MN PMN threshold Events in this region are not classified as basophils and are excluded from the basophil count The BASO Suspect parameter is calculated from the Baso Coun
127. E CHARACTERISTICS 43 PERFORMANCE CHARACTERISTICS ANALYTICAL 43 INTENDED USE a eo rie Yee c EE OPE TECH ee rere 45 PRINCIPLES OF THE 2 000000 0 02000200 00000000000000000000000 45 REAGENTS ere eee e eec ree 47 STORAGE AND STABILITY vcaviesiecseteccesesvesuedencactseseuedees cuca A 49 GAIN ADJUSTMENT iicet rette HR ER E EHE VIP 49 CALIBRATION reticere ciere 49 SAMPLER HANDLING cere tede erue d e 50 MATERIALS REQUIRED BUT NOT 20 0 000 50 luo 51 QUALITY CONTROL 2 51 RESULTS MEE 51 LIMITATIONS OF THE PROCEDURE 2 0 0000 0 00000000000000000000000 51 EXPECTED VALUES rennin ie Ro ER ien ttr ere E ce REIP 52 PERFORMANCE CHARACTERISTICS IMPRECISION eese enne 52 PERFORMANCE CHARACTERISTICS CORRELATION 53 RETICULOCYTE METHOD csssssssssssssessessssessessssessessssessessssessessssessessssessesseses 94 INTENDED USE seed toit tear 54 PRINCIPLES OF THE 2 202 222 1 00000000000000000000 54 soon eique e ni
128. EGULAR FLOW RATE HGBIFR 32 HGB POWER LOW HGB PL PH sese ener enne rennen entere enne 33 LASER POWER LOW LAS PL PL enne enne enne 33 No NRBC LYMPH VALLEY NRPXNV NV 34 IRREGULAR FLOW RATE PXIFR XR enne 34 NO VALLEY PX NV 35 NOISE PX NOj NX ene aret ent etae 36 POWER LOW PX PL PX cccssccccsssseceeessececesssececseseececseeeeeseaeeecseaeeeenseeeeees 38 SATURATION PX SAT 5 2 0 0600000010060000000000000000000000000001 38 TEMPERATURE OUT OF RANGE PXTO TX sss 40 PLATELET NOISE NI ninh nimc iE CO epe 40 PLATELET ORIGIN NOISE PLTORN 0 00 0 04 00000000000 enne 41 RBC IRREGULAR FLOW RATE RBCIFR 41 RETIC PLT INTERFERENCE ERROR RTCINT 0 000 42 RETIC ABSORPTION DISTRIBUTION ABNORMAL RTCADA 43 RETIC ABSORPTION FLATNESS RTC FL 44 RETIC FIr SUSPECT RTC FS FC tete epe es 45 RETIC IRREGULAR FLOW RATE RTCIFR 0400 45 RETIC NOISE ORIGIN RTC NO nennen nennen 4
129. ERISTICS IMPRECISION 2 000 30 PERFORMANCE CHARACTERISTICS CORRELATION 30 PERFORMANCE CHARACTERISTICS CARRYOVER csssssssecececsessssscecececeesenseceeeeeceenesees 31 PERFORMANCE CHARACTERISTICS ANALYTICAL 32 Regulatory Information 9 1 INTENDED USE pete re PRINCIPLES OF THE PROCEDURE T REAGENT ande dre etii eee ss tiec STORAGE AND STABILITY cccssssccccececsesseaececececsenseaececececsesneaeceecceceesaaececeesesensaaeeeeecs CALIBRATION ue UL eiua Ee URN VERE EP E EUCH v REPE SAMPLE HANDLING 55s ceste teet t esee aeui et estere ed e erede MATERIALS REQUIRED BUT NOT 10 PROCEDURE FOR RUNNING CSF SAMPLES 5 QUALITY CONTROL RESULTS ssepe E E E E S LIMITATIONS OF THE PROCEDURE 0 2 0 01020 00000000010000000000000000000 INTERFERING SUBSTANCES is EXPECTED V AEUBS 4 n Eie UR d Ee ves ue cca PERFORMANCE CHARACTERISTICS PRECISION ccssessscecececeesensececececeessececeeeeseneaees 41 PERFORMANCE CHARACTERISTICS 0 0 00 42 iu ep eren eau 42 PERFORMANC
130. F window Select Cancel to keep using the CSF features NOTE If any samples were processed or cycles run in the CSF mode the system will perform a hydraulic exit cycle If no samples or cycles were run in CSF mode the system simply exits CSF mode 9 If a system left in CSF mode has made the transition to Standby and you want to exit CSF mode to run whole blood samples switch to whole blood operation before exiting standby This will reduce unnecessary reagent use Quality Control Quality control of the CSF Assay is performed using ADVIA 120 TESTpoint CSF Controls containing one each of Level 1 and Level 2 controls These controls are intended to be integrated into a clinical laboratory s own quality control program and procedures Follow the package insert instructions for assaying the control products Product Number Symbol Contents Amount mL T03 4485 01 CSF Controls 2x3mL T03 4486 01 4 Control Level 1 3 mL 03 4487 01 2 Control Level 2 3 mL Control materials should be assayed e At the beginning of each shift or at some other interval chosen by the laboratory Regulatory Information e After a reagent lot number change e After replacement of any part or component of the analytical module that may affect analytical performance NOTE Moving Average calculations are not available for CSF results Results The system automatically performs all calculations
131. F differential percentage monocyte cell count CSF RBC The reportable CSF red blood cell count RBC uL CSF WBC The reportable CSF white blood cell count WBC uL CSF PMN The reportable CSF absolute polymorphonuclear cell count CSF PMN The reportable CSF differential percentage polymorphonuclear cell count CSF MN The reportable CSF absolute mononuclear cell count CSF MN The reportable CSF differential percentage mononuclear cell count 8 19 8 20 CSF Neut The reportable CSF absolute neutrophil cell count CSF Neut The reportable CSF differential percentage neutrophil cell count CSF Lymph The reportable CSF absolute lymphocyte cell count CSF Lymph The reportable CSF differential percentage lymphocyte cell count CSF Mono The reportable CSF absolute monocyte cell count CSF Mono The reportable CSF differential percentage monocyte cell count CSF RBC The reportable CSF red blood cell count RBC uL CSF Eos The research only CSF differential percentage eosinophil cell count CSF Eos The research only CSF absolute eosinophil cell count Methods Hemoglobin Method Methods Chemical Reactions The ADVIA 22120 21201 22120 21201 Hematology system normally uses cyanide free hemoglobin method but can be configured to use a reagent that contains cyanide The sample and the ADVIA 2120 2120i CN FREE HGB reagent or ADVIA 2120 21201 HGB reagent are mixed in the hemoglobin reaction ch
132. G THE CHAMBER ssscccccecessesssseceeececsesseaeeecececeesnsuececeeeceensaaeeesececeenenseea fi CLEANING THE AUTOSAMPLER RINSE TO W ASTE LINE V45 PATHWAY 8 CLEANING THE VENT LINES VACUUM SHUTTLE CHAMBERS AND REACTION CHAMBERS rir e rd e E ce OR RU CLEANING THE FLOWCELLS ON THE ANALYZER CLEANING THE FLOWCELLS OFF THE ANALYZER BACKFLUSHING THE PEROX FLOWCELL AND SHUTTLE AND REACTION CHAMBERS 21 BACKFLUSHING THE RBC BASO RETIC FLOWCELL AND SHUTTLE AND REACTION CHAMBERS adv dui el dade iet der HE get ee 23 REPAIR AND 2 0 40 0 enses en sn senses en sene seen seneeeenss 25 REPLACING THE CLOT FILTERS 2229 REPLACING THE DIAPHRAGM PUMPS 26 REPLACING THE DRAIN FILTERS 27 REPLACING PEROX CHECK VALVE ccccesssssssecececsessaececececseseaaececececeensaeeeseeeeeeneaaees 29 REPLACING THE FRONT SHEAR FACE OR THE SHEAR VALVE ROTOR 2 29 REPEACING THE FUSES 31 REPLACING THE HEMOGLOBIN COLORIMETER 33 REPLACING THE HYDRAULIC 34 REPLACING THE OPEN TUBE SAMPLER 20 2020000 37 REPLACING THE PEROX 1 0 02000000200010000000000000000 38 REPLACING THE PEROX 000 0111 111
133. H This is the ADVIA RETIC Low Control symbol 8 i This is the DEFOAMER symbol This is the EZ KLEEN symbol This is the BASO Reagent symbol ENT This is the CSF Reagent symbol This is the HGB Reagent symbol This is the CN FREE HGB Reagent symbol This is the PEROX 1 Reagent symbol This is the PEROX 2 Reagent symbol This is the PEROX 3 Reagent symbol This is the PEROX SHEATH symbol This is the RBC PLT Reagent symbol ees 5 z This is the SHEATH RINSE symbol Interpretation of Results System operators and laboratory supervisors are responsible for operating and maintaining Siemens products in accordance with the procedures described in the applicable Product Labeling online documentation package inserts bulletins and for determining that product performance conforms to the applicable claims Warnings and Safety Information B 9 If under these prescribed conditions of operation and maintenance an aberrant or abnormal result as defined by the laboratory protocol occurs laboratory personnel should first make certain that the system is performing and is being operated in accordance with the Product Labeling then follow the laboratory protocol for advising the clinician of a result that appears to have deviated from the norms established by the laboratory Siemens products do not make diagnoses on patients Siemens intends its diagnostic products systems reagents software hardware to be used
134. IA AUTOSLIDE SLIDE MAKER STAINER eeecen entente nonton nune 10 1 uunc 10 2 AUTOSLIDE SAFETY INFORMATION AND 00200 0 0 1 10 5 THEORY OF OPERATION LESE 10 8 AUTOSLIDE DAILY 10 9 AUTOSLIDE OPERATION 10 10 LOADING REAGENTS os teret E c eR EEEP VE e 10 10 LOADING SEIDE RACKS beers re o 10 11 EOADING SLIDES ite eet eoo tree e eie erede d eee o 10 11 EMPTYING THE STAIN WASTE CONTAINER eren enne nnne ennt nnne 10 11 RUNNING THE DAILY STARTUP MANUALLY eene 10 12 ORDERING A SLIDE 22 10 12 STAINING MANUALLY SMEARED 61 8 12 1 20000 00 enne enean en 10 12 RESETTING THE AUTOSLIDE MODULE ccce 10 13 STOPPING THE AUTOSLIDE MODULE FAST 5 10 13 RUNNING THE DAILY SHUTDOWN MANUALLY eene 10 13 DISCONNECTING AN AUTOSLIDE 90 10 14 AUTOSLIDE METHODS 10 18 PERIODIC MAINTENANCE 2 44 40 0 2 0600100000000000000000000000000000000 10 32 ERROR MESSAGES AND SUGGESTED 8
135. IF ANY OF THE FOLLOWING EVENTS OCCUR THE WARRANTY OR SERVICE PROVISIONS DO NOT APPLY 1 Repairs or modifications have been made to the instrument by someone other than an authorized Siemens representative 2 The instrument has been operated using accessories and supplies other than Siemens brand accessories or consumable supplies and or reagents not having the same grade quality and composition as defined in the system operator s manuals 3 Siemens has notified customers of a change that improves the performance or reliability of their instrument and customer has not agreed to retrofit or make design changes to the instrument 4 Customer did not purchase the instrument from Siemens or one of its authorized distributors 5 The instrument has not been installed within 90 days of shipment to the customer s facility unless otherwise specified 6 The customer has not performed appropriate customer maintenance procedures as outlined in the system operator s manuals 7 The instrument has been misused or used for a purpose for which it was not intended 8 The instrument has been damaged in transit to the customer or damaged by the customer while moving or relocating it without supervision by a Siemens representative 9 Damage was caused by floods earthquakes tornados hurricanes or other natural or man made disasters 10 Damage was caused by Acts of War vandalism sabotage arson or civil commotion Legal Infor
136. ING THE DAILY SHUTDOWN MANUALLY eee ee eee en eee eene 15 DISCONNECTING AN AUTOSLIDE 90 CONFIGURATION e ee een eene 15 AUTOSLIDE METHOPLNDS 5 osea o eere eep pet ep EE Sn aep ro Fo e do raa eaa 20 MAY GR NWALD GIEMSA 20 MODIFIED WRIGHT 25 WRIGHT GIEMSA METHOD eee e n e nen nnn nnn nnn nn nnn nnn nn nn nnne nen 32 PERIODIC 1 4 4 1 4 44 4044444 40244 0 0 0 01 00004000400000 440 000 0020 37 REMOVING GLASS PARTICLE 5 37 CLEANING THE STAIN OVERFLOW 39 PERFORMING WEEKLY SHUTDOWN AND 5 40 CLEANING THE STAINER WELLS AND PLATE ccccccccccccceccccececcscecscscseecessesesesssesseseeseees 40 CLEANING THE FAN 88888888787 43 REPLACING THE SMEARING AND CLEANING THE SMEARING 43 REPLACING THE PRINTER 45 REPLACING THE AUTOSLIDE 46 ERROR MESSAGES AND SUGGESTED 8 00 47 AUTOSLIDE SPECIFICATIONS ssscccsssssccsssscccssssccscssscccssssscccsssccscssseccscsssesseses 52 ADVIA Autoslide Slide Maker Stainer 10 1 Overview The optional ADVIA Autoslide Slide Maker Stainer is connected to the ADVIA 2120 21201 Hematology System and controlled by the ADVIA 2120 21201 system
137. L 4x 4 0 mL 4 0 mL Amount mL 4x 4 0 mL Regulatory Information REF Product Number Symbol Contents Amount mL T03 3690 01 Reticulocyte Control 4 0 mL Low Protect product from freezing When stored at 2 C to 8 C unopened ADVIA OPTIpoint Prod No T03 3682 01 ADVIA SETpoint Calibrator Prod No T03 3685 01 and ADVIA TESTpoint Reticulocyte Controls Prod No T03 3690 01 Low and T03 3691 01 High respectively are stable until the last day of the month expiration date printed on the product label unless otherwise stated After being opened ADVIA OPTIpoint is stable for 7 days ADVIA TESTpoint Reticulocyte Controls are stable for 10 days and the ADVIA SETpoint Calibrator is stable for 5 days when stored closed in their original containers at 2 C to 8 C Gain Adjustment The gain adjustment procedure is used to adjust the amplification signals in a channel to properly position the cell signatures within a cytogram Calibration The system must be calibrated for all parameters except RETIC Properly setting the RETIC gain factor provides sufficient accuracy of the result for most laboratories In such cases do not change the factory set calibration factor of 1 00 However laboratories using a manual counting method other than those recommended by NCCLS or ICSH or laboratories using certain flow cytometric methods could observe a significa
138. L 8 24 RDW 72 72 HDW g dL 72 72 PLT 103 uL 48 48 MPV fL 8 8 Regulatory Information 9 27 Materials Required but not Provided For the ADVIA 2120 2120i Hematology System the other materials required to perform the ADVIA 2120 2120i CBC method are the various control materials calibrators ADVIA OPTIpoint and other reagents or equipment specified in the Methods Introduction section Procedure To run samples on your ADVIA 2120 2120i Hematology System refer to the Daily Routine Quality Control It is recommended that the system be controlled using ADVIA TESTpoint Hematology Controls Please refer to page 5 for product descriptions These controls are intended to be integrated into a clinical laboratory s own quality control program and procedures Control materials should be assayed e At the beginning of each shift or at some other interval chosen by the laboratory e After a reagent lot number change e After replacement of any part or component of the analytical module that may affect analytical performance As an option laboratories may run a retained patient sample periodically to monitor performance trends Results The ADVIA 2120 21201 Hematology System automatically performs all calculations necessary for obtaining final results Through the use of flagging algorithms laboratory personnel are alerted to suspected abnormal conditions These conditions are indicated by the appropriate flag such as
139. LI is used to set the severity levels for this flag The LI is the PMN peak channel number on the Baso X histogram divided by 14 and it is greater than 1 9 for normal samples Values lower than 1 9 are usually indicative of sample abnormality In samples where a bimodal distribution is not present only PMN populations with PMN peaks greater than channel 20 will be considered as valid PMN populations Below channel 20 the software will interpret the peak as a MN population and the LI value will be blanked Whenever a PMN peak is identified the LI result will be reported NOTE If there is no value for MNx there is also no value for the Lobularity Index LD 1 MN peak channel 2 MN PMN valley channel 3 PMN peak channel Default trigger values for the three Left Shift severity levels are LI gt 1 9 LI 1 7 to 1 9 LI 17 Flags Flags Results Flagged none Possible Causes The following list of sample related causes may not contain all conditions that could cause this flag Multiple occurrences of this flag especially for consecutive samples can indicate a system problem However isolated instances of this flag are usually sample related Sample Related System Related e Aged samples 1 Troubleshoot the baso channel e Chronic infections 2 Troubleshoot the perox channel e Myeloproliferative disorders e Neonatal samples Macrocytosis MACRO Definition The Macrocytosis flag is triggered if the perc
140. LY MPH 31 3 0 9 2 9 MONO 7 2 0 5 6 9 3 4 0 3 8 8 BASO 0 5 0 1 20 0 LUC 2 5 0 4 16 0 Regulatory Information Performance Characteristics Correlation Data The performance of the ADVIA 120 Hematology System was compared with the performance of the Technicon He3 RTC System x using whole blood from 60 normal donors and 70 hospital donors with each sample run in duplicate n 260 The following regression statistics were computed using a protocol similar to that recommended in the NCCLS document EP9 A Method Comparison and Bias Estimation Using Patient Samples Approved Guideline 1995 Parameter Comparative System or Method YNEUT Technicon He3 RTC Technicon He3 RTC Technicon He3 RTC EOS Technicon He3 RTC BASO Technicon He3 RTC LUC Technicon He3 RTC x Technicon He3 RTC system y ADVIA 120 Hematology system Regulatory Information Regression Equation y 1 02x 0 6 1 00x 0 8 0 85x 0 3 0 87x 0 2 0 67x 0 0 0 92x 0 6 r 0 997 0 997 0 943 0 979 0 772 0 944 5 1 6 1 7 0 8 0 4 0 2 0 7 9 53 Reticulocyte Method 9 54 Intended Use The ADVIA 2120 21201 Hematology System Reticulocyte Count RETIC method is intended to quantitatively measure the following reticulocyte parameters e Reticulocyte concentration e Reticulocyte percentage e Reticulocyte Cell Hemoglobin Content CHr Principles of the Proc
141. N QUALITY 15 SYSTEM METHOD INFORMATION GAIN ADJUSTMENT 0 0 031 enne enne 15 SYSTEM METHOD INFORMATION CALIBRATION a SYSTEM METHOD INFORMATION RESULTS SYSTEM METHOD INFORMATION LIMITATIONS OF THE 16 SYSTEM METHOD INFORMATION EXPECTED VALUES sssessssecececeesscececececeessseeeeees 17 SYSTEM METHOD INFORMATION PERFORMANCE CHARACTERISTICS CLSI DOCUMENT M29 A3 AND SIEMENS METHOD TOPICS CROSS INTENDEPBDSE etiem att dome eee oe oe Bes 21 PRINCIPLES OF THE PROCEDURE 2522 HEMOGLOBIN 22 2440000000000000000000000000000 22 6 ER 23 STORAGE AND STABILITY cccssssccecececsessnaccecececsessnaecececscsessaaecececeesessnaececeesesessaaeeeeees 26 GAIN ADJUSTMENT 4 06303 oer o icu evt d E HAGE ERR 26 CALIBRATION ttt aita ue nitum 26 SAMPLE HANDLING cheer eee ER PEE D PERPE Ee dear ta eR eus 27 MATERIALS REQUIRED BUT NOT 28 PROCEDURE erasa ced iare ear e RR Men ad E 28 QUALITY CONTROL mete Rete aet bits oh eei me bel Rd 28 RESUETS EMI am IU MB IMMER tes 28 LIMITATIONS OF THE PROCEDURE 29 EXPECTED V AEUES 4 Rae RR ree iei endete Re EA 29 PERFORMANCE CHARACT
142. NEUT LYMPH LYMPH MONO EOS EOS LUC and LUC Corrective Action Multiple occurrences of this flag especially for consecutive samples can indicate a system problem However isolated instances of this flag are usually sample related The following list of sample related causes may not contain all conditions that could cause this flag There is no intention to associate the flag with specific diagnoses System Related Sample Related 1 Check perox reagents e Immature locyt 2 Check peroxidase hydraulics and sample delivery e Severe toxic Check delivery of SHEATH RINSE granulation Check PEROX SHEATH delivery e Promyelocytic leukemia Check the pressure and vacuum readings Check the perox reaction chamber temperature Check perox flowcell alignment un B 5 Check perox gains 6 39 Perox Temperature out of Range PXTO TX Definition The Perox Temperature Out of range flag is triggered if the Peroxidase reaction chamber temperature is not between 58 C and 72 1 C The PXTO TX flag is not triggered if agreement between the baso and perox results is indicated by both the following conditions e WBCB and WBCP agree within specified limits No WBC CE flag EOS PMN is between 0 and 7 5 Results Flagged WBCP NEUT NEUT LYMPH LYMPH MONO EOS EOS LUC and LUC Corrective Action 1 Check the perox reaction chamber t
143. NTRATION VARIANCE HCV eere nennen enne 8 HYPERCHROMIA 1100000000000000000000000000000000 8 HYPOCHROMIA HYPO 5 28 55 8 vie ELE 9 IMMATURE GRANULOCYTES IG a ee E EE a EEEE EE 10 LARGE PLATELETS LPLT e e aa e aa a a nes inerte nnns 11 LEEFESHIET US a le RCRA 12 MACROCYTOSIS MACRO rren RR IB aE E E R 13 MICROCYTOSIS MICRO 4 2 t a RAE AN Ha ARORA LS 14 MYELOPEROXIDASE DEFICIENCY MPO D 15 NUCLEATED RED BLOOD CELLS NRBO sess enne ene 16 PLATELET CLUMPS PLT CLM 17 RB FRAGMENTS RBCD 4 aed Rave Bates ae tea 18 RBC GHOSTS RBCO O ec ed eme hebetes 19 SAMPLE SYSTEM FLAGS creer esee esee esten ette ets 21 SUMMARY tata nata Ai naeh hae Araneae 21 BASO COUNT SUSPECT B SUSP 25 BASO IRREGULAR FLOW RATE BIFR 26 BASO NOISE BENO mere e B ri REED PE 27 BASO NO VALLEY B NV VB 5 uiae aceti at ates e WARS 28 BASOSATURATION B SAT BS rude eee re RHET 29 BASO TEMPERATURE OUT OF RANGE 30 COMPARISON ERROR MCHC CHCM CC esee 31 COMPARISON ERROR WBCB WBCP WBC CE 32 HGB IRR
144. PN T03 3682 01 ADVIA SETpoint Calibrator PN T03 3685 01 and ADVIA TESTpoint Reticu are stable until the last day of the month expiration date printed on the product label unless otherwise stated After being opened ADVIA OPTIpoint is stable for 7 days when stored closed in its original containerat 2 C to 8 C Ancillary Reagents The following ancillary reagents are necessary to operate the ADVIA 2120 21201 Hematology System All reagents must be free of particulates and other foreign matter ADVIA 120 SHEATH RINSE Product Number T01 3664 01 T01 3623 01 Product Number T01 3624 54 T01 3624 01 ADVIA 120 DEFOAMER Product Number T01 3625 54 T01 3625 01 Operation Symbol SHEATH RINSE ADVIA 120 EZ KLEEN Symbol Symbol DEFOAMER Contents SHEATH RINSE SHEATH RINSE Contents EZ KLEEN EZ KLEEN Contents DEFOAMER DEFOAMER Amount L 10L 20 L Amount mL 4x 810 mL 810 mL Amount mL 4x 125 mL 125 mL To run samples on your ADVIA 2120 2120i Hematology System refer to the Daily Routine Regulatory Information NOTICE Any modification of computer disks and or the programs contained on such disks can adversely affect the control of instrument performance and thereby invalidate the results obtained as well as the claims that have been made regarding system performance In no event shall Siemens be liable for errors that are introduced by or result from any modific
145. ROX 2 Reagent Low Alarm The number of consecutive occurrences of this condition has met the criterion specified for an alarm message indicating that the reagent level is low The specified alarm criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria Reagent Conditions Corrective Action The alarm counter is automatically reset after reagents are replenished and the Reagent Installation window is updated Go to Logs Reagent Log Reagent Installation PEROX 3 Reagent Empty Stop The number of consecutive occurrences of this condition has met the criterion specified for a stop message The reagent is empty and the autosampler has halted The specified alarm criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria Reagent Conditions Corrective Action The stop counter is automatically reset after reagents are replenished and the Reagent Installation window is updated Go to Logs Reagent Log Reagent Installation Select Start Stop to continue the run Status Line messages PEROX 3 Reagent Expired Present date is beyond the PEROX 3 reagent expiration date as determined by encoded reagent container barcode label or as calculated from installation date and open container stability Corrective Action Replenish expired reagents and update the Reagent Installation window Go to Logs Reagent Log Reagent Installation PEROX 3 Reagent Low Alarm The number of consec
146. Reagent Installation window is updated Go to Logs Reagent Log Reagent Installation Error Opening Port This error can occur during the system preparation initialization process Corrective Action Status Line messages 7 47 Select Shut Down ADVIA in the Log On Off window Select CTRL ALT DELETE and log back onto the system to restart the software If the error recurs check the communication port where the problem occurs COM 1 or MCA Serial Board EZ KLEEN Reagent Empty Stop The number of consecutive occurrences of this condition has met the criterion specified for a stop message The reagent is empty and the autosampler has halted The specified stop criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria Reagent Conditions Corrective Action The stop counter is automatically reset after reagents are replenished and the Reagent Installation window is updated Go to Logs Reagent Log Reagent Installation Select Start Stop to continue the run EZ KLEEN Reagent Expired Present date is beyond the EZ KLEEN reagent expiration date as determined by encoded reagent container barcode label or as calculated from installation date and open container stability Corrective Action Replenish expired reagents and update the Reagent Installation window Go to Logs Reagent Log Reagent Installation EZ KLEEN Reagent Low Alarm The number of consecutive occurrences of this condition has met the
147. Stop The number of consecutive occurrences of this condition has met the criterion specified for a stop message The autosampler halts at the same time the stop message occurs The specified stop criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Stop Criteria is reset when the Start Stop button is selected Nucleated Red Blood Cells Alarm The number of consecutive occurrences of this condition has met the criterion specified for an alarm message The specified alarm criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Alarm Criteria is automatically reset Nucleated Red Blood Cells Stop The number of consecutive occurrences of this condition has met the criterion specified for a stop message The autosampler halts at the same time the stop message occurs The specified stop criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Stop Criteria is reset when the Start Stop button is selected gt NULL Delta Check Alarm Not Defined The Delta Check mechanism is defined in the parameter file but not in the Alarm Dictionary Corrective Action Define the Delta Check alarm in the Alarm Dictionary NULL Delta Check Alarm Not Selected The Delta Check mechanism is not defined in the parameter file Corrective Action Call Siemens Servi
148. System Related e Hereditary spherocytosis 1 Check RBC reagents e Sickle cell anemia 2 Check the laser sample delivery e Hemolytic uremic 3 Check the RBC gains 4 Check the laser flowcell alignment Hypochromia HYPO Definition The Hypochromia flag is triggered if the percentage of cells with low cellular hemoglobin concentration HYPO is equal to or greater than 4 0 The HYPO parameter indicates the percent of cells that have a cellular hemoglobin concentration less than 28 g dL and is derived from the RBC HC histogram Default trigger values for the three severity levels are t 4 0 to 7 9 8 0 to 12 0 gt 12 0 The HYPO value is intended for flagging and laboratory purposes only Results Flagged none Possible Causes The following list of sample related causes may not contain all conditions that could cause this flag Multiple occurrences of this flag especially for consecutive samples can indicate a system problem However isolated instances of this flag are usually sample related 6 9 Sample Related System Related e deficiency anemia 1 Check RBC reagents e Chronic inflammatory Check the laser sample delivery 2 diseases 3 Check the RBC gains 4 Mi Check the laser flowcell alignment e Sideroblastic anemias Immature Granulocytes IG Definition The presence of immature granulocytes is suspected The Immature Granulocyt
149. TIC reagent contains a zwitterionic detergent surfactant that isovolumetrically spheres the red cells It also contains a cationic dye Oxazine 750 that stains cells according to their RNA content Measurement A constant volume of the cell suspension from the retic reaction chamber passes through the flowcell where the low angle light scatter 2 to 3 the high angle light scatter 5 to 15 and the absorption signatures for each cell are measured ADVIA 2120 21201 SHEATH RINSE encases the sample stream as the two fluids pass through the flowcell The low angle and high angle light scatter signatures are proportional to cell size and hemoglobin concentration Light absorption is proportional to RNA content The stained reticulocytes will absorb more light than the mature RBCs The two light scatter signals and the absorption signal are detected electronically amplified and split into six signals One of the low angle light scatter signals is amplified 28 times One of the high angle light scatter signals is amplified 12 times One of the absorption signals is amplified 33 times After processing this information is available RETIC Rate histogram displays the arrival rate of cells in the retic channel RETIC Abs Flatness histogram displays the mean absorption at 200 millisecond intervals RETIC Abs histogram displays the overlaid distribution of mature RBCs and reticulocytes by their absorption values RETIC Volume histog
150. The LPLT parameter indicates the percent of platelets with volumes greater than 20 fL This parameter is derived from the Platelet Volume histogram based on Integrated Analysis Default trigger values for the three severity levels are t LPLT 10 0 to 11 9 LPLT 12 0 to 14 0 gt 14 0 The LPLT value is intended for flagging and laboratory purposes only Results Flagged none Possible Causes The following list of sample related causes may not contain all conditions that could cause this flag Multiple occurrences of this flag especially for consecutive samples can indicate a system problem However isolated instances of this flag are usually sample related 6 11 6 12 Sample Related System Related e CML 1 Check the RBC reagents e Bone marrow transplant Check the RBC hydraulics 2 e Chemotherapy 3 Check the RBC and PLT gains 4 Check the laser flowcell alignment Left Shift LS Definition The presence of nonsegmented neutrophils bands is suspected The Left Shift flag is triggered if bands obstruct the MN PMN valley The flag is not triggered if is less than 30 For normal samples the valley separating the MN and PMN populations is well defined as determined by its relative depth d D If this valley becomes too shallow d D lt 0 15 the MN and PMN populations cannot be separated The LS flag is triggered if BASO d D is less than 0 15 The Lobularity Index
151. The Wright Giemsa method is for in vitro diagnostic use in the differential staining of blood bone marrow and body fluid smears on the ADVIA Autoslide Slide Maker Stainer Stained smears are evaluated to identify and quantify cells in whole blood and other specimens to aid clinicians in the assessment of various clinical conditions Summary and Explanation The reagent protocol for the Autoslide Slide Maker Stainer consists of a modified polychrome methylene blue eosin stain and is based on the original stain proposed by Romanowsky The ADVIA Autoslide Slide Maker Stainer is a smart fully automated system It is capable of producing stained smears on all specimens run on the ADVIA 2120 21201 or only on samples with predefined criteria i e flags or parameter threshold The Autoslide also provides a direct access port to the stainer for pre smeared slides Staining Protocol The following is a brief description of the staining protocol 1 2 3 4 5 6 7 8 9 10 11 Dispensing Modified Wright or Wright Giemsa Stain DN1 Slide introduction Draining Modified Wright or Wright Giemsa Stain AN3 Dispensing diluted Modified Wright or Wright Giemsa Stain DN3 Draining AN7 Dispensing rinsing solution distilled water DN7 ADVIA Autoslide Slide Maker Stainer 7 Draining AN7 8 Dispensing rinsing solution distilled water DN7 9 Draining AN4 10
152. The following is a brief description of the staining protocol 1 Dispensing May Griinwald Stain Stain 1 DN1 2 Slide introduction 10 20 ADVIA Autoslide Slide Maker Stainer Partial draining of May Griinwald Stain Stain 1 AN2 Dispensing Buffer to dilute May Gr nwald Stain Stain1 DN3 Draining AN3 Dispensing diluted Giemsa Stain Stain 2 DN3 Draining AN7 Dispensing rinsing solution distilled water DN7 SO gen ON Ee Draining AN7 10 Dispensing rinsing solution distilled water DN7 11 Draining AN7 12 Draining AN4 13 Dispensing methanol DN4 14 Slide removal Needle Position Action DNI Undil Stain 1 32 1 DN2 Buffer 8 1 DN3 Dil Stain 2 13 1 DN4 Methanol 31 0 DN7 Rinse 18 2 AN2 8 1 AN3 13 1 AN4 31 1 AN7 18 3 Methanol Volume mL 1 6 Stain Volume mL 3 6 Dilution Ratio 5 Duration Long Principle of the Procedure The 2 staining mixtures used by this protocol have very distinct proprieties The May Gr nwald STAIN 1 stains acidophilic sites of cells and the neutrophilic granulations of leukocytes whereas the Giemsa STAIN 2 stains the cytoplasm of the monocytes and lymphocytes as well as the nuclear chromatin The stained smear is examined microscopically and cells are then manually differentiated and quantified Cell Type Cell Component Color Neutrophils Nuclei Deep purple ADVIA Autoslide Sl
153. Time x Perox Nominal Factor CSF Mono 100 x CSF Mono CSF WBC CSF Mono uL CSF PHA Mono CSF PHA Total x CSF PHA Cells 1 Fractional Dead Time x Perox Nominal Factor CSF RBC uL CSF R Count CSF PHA Total x CSF PHA Cells 1 Fractional Dead Time x Perox Nominal Factor 8 17 Additional Parameters The following parameters are for research or laboratory use only and are not for patient reporting Parameter Eos CSF Eos CSF PHA Total CSF PHA Cells CSF Noise CSF PHA WBC CSF PHA Eos CSF PHA Lymphs CSF PHA Monos CSF PHA Neuts Explanation CSF Eos 100 x CSF Eos CSF WBC CSF Bos uL CSF PHA Eos CSF PHA Total x CSF PHA Cells 1 Fractional Dead Time x Perox Nominal Factor The total number of cells displayed in the CSF Scatter Scatter cytogram including the noise region The total number of cells displayed in the CSF Scatter Scatter cytogram excluding the noise region The percentage of cells that are located in the noise region of the CSF Scatter Scatter cytogram The number of cells falling into the WBC regions of the CSF Scatter Scatter cytogram The number of cells falling in the Eosinophil Region of the CSF Scatter Absorption cytogram The number of cells falling in the Lymphocyte Region of the CSF Scatter Scatter cytogram CSF PHA Monos is the number of cells falling in the Monocyte Region of the CSF Scatter Scatter cytogram The number of neutro
154. V sample system flags lysis are triggered troubleshoot the perox channel Nucleated red blood 2 If there are no perox flags troubleshoot the cells baso channel e Malaria parasites Hgb Irregular Flow Rate HGBIFR HR Definition The HGB Irregular Flow Rate flag is triggered if HGB baseline or sample transmission is erratic For each sample the difference between the maximum and minimum transmittance is obtained for the baseline and sample transmittance The flag is triggered if the baseline or sample value is greater than 1000 Flags HGB Trans Histogram o 27 1 Sample transmittance Fu 2 Baseline transmittance Results Flagged HGB MCH and MCHC Corrective Action 1 Check HGB reagents Check Hgb hydraulics and sample delivery 2 3 Check delivery of SHEATH RINSE 4 Check the pressure and vacuum readings Hgb Power Low HGB PL PH Definition The Hgb Power Low flag is triggered if the HGB baseline transmission is less than 2 5 or greater than 4 1 Results Flagged HGB MCH and MCHC Corrective Action 1 Adjust the Hgb baseline 2 Perform the rinse reagent check 3 Replace the Hgb lamp Laser Power Low LAS PL PL Definition The Laser Power Low flag is triggered if the laser light intensity in the RBC Baso Retic channel is less than 150 Results Flagged RBC HCT MCV MCH MCHC CH CHDW CHCM RDW HDW PLT MPV PDW WBCB WBC BASO BASO RETIC RETIC CHg CHr CHCMg CHCMr CHDWr
155. Vacuum gauge Check the system vacuum gauge and adjust the regulator is out of range if necessary Setpoint 20 Hg 1 2 Vacuum leak Check for crimped or disconnected hydraulic or pneumatic lines Straighten or reconnect lines as necessary b Check the waste container to make sure that the spigot is closed and the cap is on securely Status Line messages Valve Node 1 Error Reset Required Potential software communication error or a hardware failure associated with the Valve Driver Board Possible Cause 1 Hardware failure 2 Faulty power supply fuse cable Valve Driver Board or Can Bus Scrambler Board Corrective Action a b Reset the analyzer by selecting Utilities Exerciser Indicators Analyzer Reset After about 1 minute if the status line does not display Ready to Run and the green ready to aspirate light is still off follow these steps to exit the ADVIA 2120 21201 software turn off the analyzer and then restart i Select Shut Down at the Log On Off window ii Select Off at the analyzer touchpad iii Select CTRL ALT DELETE and log back onto the system to restart the software iv Restart the analyzer by pressing On at the analyzer touchpad Call Siemens Service for assistance Valve Node 2 Error Reset Required Potential software communication error or a hardware failure associated with the Valve Driver 2 Board Status Line messages Possible Cause 1 H
156. WBC count if there is no BASO Noise B NO or BASO Saturation B SAT flag e If WBCB is flagged with NB or BSAT then WBCP is substituted as the WBC count if the WBCP is not flagged with e No Valley Perox PX NV e Saturation PX SAT Noise Perox e If both WBCB and WBCP are flagged then WBCB is flagged and reported as the WBC count If WBCB is less than 1000 cells uL the WBCP count is not substituted as the WBC count The WBCB count is reported as the WBC count and is flagged Flags 6 51 Status Line Messages 3 4 n ececcece 4 4 4 4 12 7 42 4 460 en 47 4 4 0 e 50 e 58 e 58 e 58 coocoo 9 2 00 n 66
157. X WBC MCTS x 0 001248 PeroxCalFactor PEROX WBC OTS x 0 001248 To view the WBC calibration factors select Cal Gain Logs at the System Logs menu 8 35 8 36 FracDT The fraction of time that the channel is busy processing flowcell events While the perox channel is busy identifying a particular flowcell event it is unable to process any additional events that might occur By measuring this dead time the analyzer can compensate for these events MPXI The mean peroxidase activity index or staining intensity of the neutrophil population relative to the archetype PEROX PHA Cells P acq The total number of events in the PEROX cytogram excluding the Noise area NOTE nRBC and PLT Clump events are components of Perox Noise Therefore they are not included in the PEROX PHA Cells PEROX PHA Total P tot The total number of events in the PEROX cytogram including the Noise area Perox Valid Cells P vc The number of valid electronic pulse signals detected from flowcell events HPX The number of events with absorption values greater than 1 4 times the X channel mean of the neutrophil cluster Clumps Count The number of events in the Platelet Clumps area 1 of the PEROX cytogram The number of events in the NRBC area 1 of the PEROX cytogram Methods Perox Noise The number of events in the Noise area 1 of the PEROX cytogram The number of events in the Saturation area 1 of the PERO
158. X cytogram RBC Platelet Method Methods Cytochemical Reactions The RBC Platelet cytochemical reactions consist of two steps Step 1 RBCs and platelets are isovolumetrically sphered using the ADVIA 2120 2120 RBC PLT reagent Step 2 RBCs and platelets are fixed ADVIA 2120 2120i RBC PLT NOTE For more detailed information on the contents of ADVIA 2120 21201 RBC PLT reagent please see Chapter 8 ADVIA 2120 21201 RBC PLT reagent contains sodium dodecyl sulfate SDS and glutaraldehyde which causes sphering of the red blood cells and platelets When red cells and platelets are isovolumetrically sphered shape is eliminated as a variability factor 8 37 8 38 Measurement A constant volume of the cell suspension from the RBC reaction chamber passes through the flowcell where the low angle light scatter 2 to 3 and high angle light scatter 5 to 15 signatures of each cell are measured ADVIA 2120 21201 SHEATH RINSE encases the sample stream as the two fluids pass through the flowcell The two light scatter signals are detected electronically amplified and split into four signals e A pair of low angle light scatter 2 to 3 and high angle light scatter 5 to 15 signals are used to analyze red blood cells low angle light scatter 2 to 3 signal is amplified 30 times and a high angle light scatter 5 to 15 signal is amplified 12 times These signals are used to analyze platel
159. acial protection gloves and protective clothing The operator should follow the recommendations to prevent the transmission of infectious agents in health care settings as recommended by the Clinical and Laboratory Standards Institute formerly NCCLS in Protection of Laboratory Workers from Occupationally Acquired Infections Approved Guideline Third Edition 2005 CLSI Document M29 A3 This document contains complete information on user protection and it can be used as reference material for instructions on laboratory safety LASER WARNING To avoid damage to the eyes never look directly at the laser beam or at its reflection from a shiny surface All field service procedures must be followed precisely Only Siemens trained field service personnel should perform procedures related to laser assemblies For more safety information and laser specifications refer to Safety Information Protecting yourself from lasers AN WARNING When handling EZ KLEEN wear protective clothing gloves and safety glasses It is harmful if swallowed and may cause eye or skin irritation IN WARNING Regular strength household bleach is 5 sodium hypochlorite Extra strength household bleach is 6 sodium hypochlorite Either strength may be used with the ADVIA 2120 2120i Hematology System When handling bleach which can be used as a cleaning and antiviral agent wear protective clothing gloves and safety glasses It is harmful if swallowed and may caus
160. activity in the granules of white blood cells as described by the following equation cellular peroxidase p 4 chloro 1 naphthol dark precipitate within the cells ADVIA 2120 2120i PEROX SHEATH NOTE For more detailed information on the contents of ADVIA 2120 21201 PEROX SHEATH reagent please see Chapter 8 ADVIA 2120 21201 PEROX SHEATH has three important functions e constrict the sample stream so that only one cell at a time can pass through the viewing area e To prevent contact between the sample stream and the flowcell walls This prevents clogs and staining of the flowcell e To provide an optically transparent medium through which the sample stream can be clearly focused Measurement A constant volume of the cell suspension from the Perox reaction chamber passes through the flowcell where the absorption peroxidase staining and the forward light scattering size signatures of all white blood cells are measured Methods ADVIA 2120 21201 PEROX SHEATH encases the sample stream as the two fluids pass through the flowcell The light scatter and the light absorption signals are detected and electronically amplified After processing the following information is available PEROX Rate histogram displays the arrival rate of cells in the Perox channel PEROX X histogram displays the absorption values for all cells Information from the noise area is excluded PEROX Y histogram displays the light scatt
161. ae A 55 STORAGE AND STABILITY 2 56 GAIN ADJUSTMENT 2 ccdevess 57 57 58 MATERIALS REQUIRED BUT NOT 110 58 eoe eant uide c SES 58 QUALITY merde dere c die ee 59 RESUETS x Sr 60 LIMITATIONS OF THE PROCEDURE 4 000 0000000000000000000000000000 enne 60 EXPECTED VALUES ttt beste ere ce denen Peer S ETHER RES 60 PERFORMANCE CHARACTERISTICS IMPRECISION ssssscscececeesesssceccceceesesseceeeeeeeeneaees 61 Regulatory Information Regulatory Information PERFORMANCE CHARACTERISTICS CORRELATION DATA PERFORMANCE CHARACTERISTICS PERFORMANCE CHARACTERISTICS ANALYTICAL RANGE METHOD DATA SUMMARY eerte 063 CBE METHOD ete emet eter ede eese e eee 63 WBE DIFE METHOD neret Nee evt ete eee ee ee ea vue Eae tn ene ET EUR ERE EVEN Eu eves 64 RETIC METHOD rre eere eie e e RN RM NU 65 9 3 Methods Introduction 9 4 Overview The Methods Introduction describes the types of information contained in the ADVIA 2120 2120i Hematology System testing methods NOTE Unless otherwise stated the pe
162. ags will appear as exclamation points Possible Cause Corrective Action 1 The Data Manager Do not use control ID labels on samples or received a sample that is set up the control in the Control identified as a control but Dictionary that has not been set up in the Control Dictionary 2 The Alarm Dictionary is Enter alarms in the Alarm Dictionary empty or missing the Delta Check alarm The Delta Check alarm must be in the Alarm Dictionary even if you do not use delta checking Status Line messages 4 Key Not Found TestDic dat ReadTestCode_08 Some samples in the database contain a test that has been deleted from the Test Dictionary Corrective Action In the Order Entry window delete these samples to avoid this error Do not modify the Test Dictionary while samples remain in the database 40 PSI Out of Range System pressure is out of range Possible Cause Corrective Action 1 40 PSI pressure Check the 40 PSI gauge and adjust the regulator if gauge is out of X necessary range Setpoint 40 PSI 2 2 Pressure leak Check for crimped or disconnected hydraulic or pneumatic lines Straighten or reconnect lines as necessary 40 PSI Out of Range Stop System pressure is out of range The system has stopped because the pressure has reached a critical level that may affect the integrity of sample results and damage the system Possible Cause Corrective Action 1 40 PSI pressure Check the 40 PSI gauge and adjust
163. ailed to Extend Reset Autosampler The autosampler pushpin failed to extend properly Status Line messages 7 33 7 34 Possible Cause 1 Pushpin is jammed 2 Pushpin catches on the bottom of an improperly positioned rack 3 Pushpin catches on the bottom of the mixer 4 Faulty output queue sensor or wiring Corrective Action a b Open the autosampler access door Close the autosampler access door The autosampler will reset If problem persists select Off at the analyzer touchpad Wait about minute and select On to restart the analyzer If the problem persists call Siemens Service for assistance Check rack position in mixer Adjust if necessary If the problem persists call Siemens Service for assistance a Check rack position in mixer Adjust if necessary If the problem persists call Siemens Service for assistance Call Siemens Service for assistance Autosampler Pushpin Failed to Retract Reset Autosampler The autosampler pushpin failed to retract properly Possible Cause 1 Pushpin is jammed 2 Pushpin catches on the Corrective Action a Open the autosampler access door b Close the autosampler access door The autosampler will reset c If problem persists select Off at the analyzer touchpad d Wait about 1 minute and select On to restart the analyzer e Ifthe problem persists call Siemens Service for assistance a Check rack position in mixer Ad
164. aining of the ADVIA 2120 21201 SHEATH RINSE and refilling with the reaction solution consisting of sample and ADVIA 2120 21201 HGB reagent 3 Reaction solution readings 15 5s to 18 0s Sample Mean 4 Draining of the reaction solution and refilling with ADVIA 2120 21201 SHEATH RINSE 5 ADVIA 2120 21201 SHEATH RINSE readings baseline transmittance for the current sample Baseline Mean value should be between 2 5 and 4 1 Methods Methods Sample readings 3 sample and ADVIA 2120 2120i HGB reagent Sample Mean 22 Sample Sampe souls Baseline readings 5 ADVIA 2120 21201 SHEATH RINSE Baseline Counts N Baseline Mean Calculating Parameters Reported Parameters The following parameters are available for patient reporting Parameter Explanation HGB log Sample Mean Baseline Mean x Hgb Cal Factor x 50 0 MCH HGB RBC x 10 MCHC HGB RBC x MCV x 1000 Additional Parameters The following parameters are for research or laboratory use only and are not for patient reporting Parameter Explanation Calculated HGB CHCM x RBC x MCV 1000 Delta HGB HGB Calculated HGB HGB Baseline Transmission Baseline Mean x 3 05194E 4 HGB Sample Transmission Sample Mean x 3 05194E 4 HGB Baseline Flatness Maximum Baseline Value Minimum Baseline Value HGB Sample Flatness Maximum Sample Value Minimum Sample Value 8 23 Parameter Key HGB Measured hemoglobin concentration MCH Mean C
165. al by manual methods Expected Parameter Value WBC cells uL 0 10 Regulatory Information Expected Parameter Value MN cells uL 0 10 PMN cells uL 0 4 Performance Characteristics Precision Within run precision on the ADVIA 120 CSF Assay was evaluated by performing replicate aspirations of 16 CSF patient samples with adequate volume Volume permitting CSF samples were aspirated 2 10 times Results from the 16 samples were pooled giving a total sample size of n 65 Precision of CSF WBC Counts n 65 Parameter Mean SD CV WBC 44 6 5 0 11 2 Precision of CSF RBC Counts n 65 Parameter Mean SD CV RBC 12 9 4 1 31 7 Precision of CSF WBC Differential n 65 Parameter Mean SD 12 5 3 2 25 5 Lymph 74 9 5 1 6 9 Mono 8 3 3 2 39 3 96 MN 832 3 6 4 3 PMN 16 8 3 6 21 2 Neut 4 8 1 1 23 6 Lymph 33 8 40 11 7 Mono 4 1 1 2 30 1 MN 37 9 4 7 12 4 PMN 6 6 2 0 29 9 Regulatory Information 9 41 9 42 Performance Characteristics Accuracy The accuracy of the CSF WBC count was evaluated by comparing manual counts from 90 samples to counts from the ADVIA 120 Hematology System Accuracy Statistics are found in the tables below CSF WBC Count The accuracy of the CSF WBC count was evaluated by comparing manual counts from 90 samples to counts from the ADVIA 120 Hematology System Accuracy statistics are found in the table below Manual ADVIA 120 R Slope Intercept Mean Mean Bias 0 981 1
166. aline samples are required verify that the pump was installed properly 7 Runcontrols to verify analyzer performance Replacing the Drain Filters If the filter is not clogged but you want to clean it because of heavy buildup or discoloration use the backflush procedure Time 10 minutes Analyzer mode Off AN WARNING The analyzer must be off otherwise personal injury from the needle may occur BIOHAZARD All products or objects that come in contact with human or animal body fluids should be handled before and after cleaning as if capable of transmitting infectious diseases Wear facial protection gloves and protective clothing The operator should follow the recommendations to prevent the transmission of infectious agents in health care settings as recommended for potentially infectious specimens in Protection of Laboratory Workers from Infectious Disease Transmitted by Blood Body Fluids and Tissue 2nd edition Approved Guideline 1997 Document M29 A National Committee for Clinical Laboratory Standards NCCLS This document contains complete information on user protection and it can be used as reference material for instructions on laboratory safety 1 Turn the analyzer off 2 Unscrew the old filter from both fittings Discard the old filter 3 Connect the new filter to the fittings and hand tighten them to ensure they are sealed Troubleshooting the Analyzer 5 27 4 Turn the analyzer on and run samples in
167. amber colorimeter The hemoglobin chemical reactions consist of two steps ADVIA CN FREE HGB Reagent Step 1 Red blood cells are lysed to release hemoglobin Step 2 The heme iron in the hemoglobin is oxidized from the ferrous to the ferric state and coordinates one hydroxide ion and one water molecule as an axial ligand to form monoaquomonohydroxyferri porphyrin as the reaction product ADVIA HGB Reagent Step 1 Red blood cells are lysed to release hemoglobin Step 2 The heme iron in the hemoglobin is oxidized from the ferrous to the ferric state and is then combined with cyanide in the ADVIA 2120 2120i HGB reagent to form the reaction product ADVIA 2120 2120i HGB NOTE For more detailed information on the contents of ADVIA 2120 21201 HGB reagent please see Chapter 8 ADVIA 2120 2120i HGB reagent contains a surfactant and potassium cyanide which are dissolved in an alkaline borate solution at pH 11 3 The surfactant hemolyzes the red blood cells and then emulsifies the cellular debris and lipids in a reaction mixture that is essentially free of turbidity After release of hemoglobin by hemolysis the combined action of an alkaline pH and the surfactant causes a rapid denaturation of the protein with solubilization of the hemes by surfactant micelles The hemes then undergo air oxidation of ferrous iron to the ferric state and combine with cyanide forming micellized ferriheme Published studies show that each ferriheme combines wi
168. ampler access door The autosampler will reset If the problem persists call Siemens Service for assistance Call Siemens Service for assistance Autosampler Collar Failed to Retract Reset Autosampler The autosampler centering collar failed to retract properly Possible Cause Corrective Action Faulty output queue sensor or wiring 1 Critical a Open the autosampler access door Sampler Error Partial b Close the autosampler access door The autosampler Reset is will reset required Critical At the analyzer touchpad select Off b Wait about 1 minute and select On to restart the Error Full 1 Reset is ANA YAST required Ifthe problem persists call Siemens Service for assistance Air lines Open the autosampler access door lying th supp Ying me b Check for kinked or pinched tubing Replace if centering coll r re necessary pinched Close the autosampler access door The autosampler resets If the problem persists call Siemens Service for assistance Call Siemens Service for assistance Autosampler Centering Collar Motion Denied Reset Autosampler The autosampler attempted an inappropriate centering collar motion An autosampler reset is required Status Line messages Corrective Action 1 Select Off at the analyzer touchpad 2 Wait about 1 minute and select On to restart the analyzer 3 If the problem persists call Siemens Service for assistance Autosampler Centering C
169. ampler needle IMPORTANT In addition to these scheduled procedures periodic inspections of the UFC pathways vacuum shuttle and reaction chambers are essential If you find buildup or dirt in any of the lines or chambers clean the line or chamber in question Maintaining the Analyzer System Wash Time 6 5 minutes Analyzer mode Ready to Run Perform the system wash procedure at the end of each shift or work period a maximum of eight hours After the laboratory shift with the largest number of samples run three system wash cycles after other shifts you need to run only one wash cycle In addition if the number of samples in a shift exceeds 400 perform one system wash after the 400th sample Example 1 Laboratory workload of 1000 samples day Shift 1 800 Samples 1 system wash after sample 400 3 system washes at the end of the shift Shift 2 100 Samples 1 system wash at the end of the shift Shift 3 100 Samples 1 system wash at the end of the shift Example 2 Laboratory workload of 300 samples day Shift 1 175 Samples 3 system washes at the end of the shift Shift2 75 Samples 1 system wash at the end of the shift Shift 3 50 Samples 1 system wash at the end of the shift Example 3 Laboratory workload of 350 samples day Shift 1 350 Samples 3 system washes at the end of the shift IMPORTANT Each EZ KLEEN container PN T01 3624 54 is sufficient for 20 system wash cycles Please order your reagents accordingly To start a system wash
170. analyzer Although there is a main power switch for the system you must also turn each component on and off individually Turning the system on 1 Check that the main power switch is set to On If the switch is in the Off position switch it to On 2 Turnon the computer a Setthe computer power switch to On b When the computer displays the Begin Logon message select Ctrl Alt and Delete at the same time to log on to Windows c Enter the operator name and password in the Logon Information box select OK d Once you have logged on to Windows using an operator name and password the computer automatically starts the ADVIA 2120 21201 software NOTE If you log on using a supervisor name and password the system opens the ADVIA 2120 21201 Shell 3 Turn on the analyzer IMPORTANT When you restart the analyzer make sure that at least 60 seconds have passed since you turned it off a Select On at the analyzer touchpad b When the computer finishes loading the software it displays the Log On Off tab A message on the status line indicates system preparation is 2 2 Turning the System On Off in progress When the system preparation is complete log on to the system During system preparation the analyzer e Performs internal diagnostics checks e Prepares the hydraulics e Primes the reagent lines e Begins the Startup process NOTE If any of the internal diagnostic checks fail the system displays an err
171. and can radiate radio frequency energy and if not installed and used in accordance with the instruction manual may cause harmful interference to radio communications Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at his own expense CE mark requirements The ADVIA 2120 21201 conforms to the following standard It therefore meets the EMC conformity requirements for CE marking according to the European IVDD Directive 98 79 EC EN 61326 1 1997 Electrical Equipment for measurement control and A1 1998 A2 2001 laboratory use EMC requirements Class A Warnings and Safety Information B 3 Noise limit requirement The ADVIA 2120 2120i conforms to the following noise limit requirement EN27779 1989 Measurement of Airborne Noise Emitted By Computer and Business Equipment 61 dBA Documentation In the printed and online documentation all hazards except those associated with reagents are categorized as follows WARNING Indicates the risk of personal injury or loss of life if operating procedures and practices are not correctly followed CAUTION Indicates the possibility of damage to or destruction of equipment if operating procedures and practices are not strictly observed IMPORTANT Indicates that system functions including test results may be adversely affected if operating procedures and practices are not
172. andards NCCLS This document contains complete information on user protection and it can be used as reference material for instructions on laboratory safety AN CAUTION When performing this procedure do not use force on the syringe at any time 1 Atthe Utilities menu select Exerciser to open the Exerciser tab 2 Disconnect the waste tubing 1 that comes from the Perox flowcell 2 at V24 This is the white fitting at V24 3 3 the cleaning syringe 4 EZ KLEEN and attach it to the white fitting Refill the syringe EZ KLEEN as needed during the following steps 4 Disconnect the sample tubing 5 from the top of the sample syringe 6 and place the sample tubing into a beaker to catch fluid as you backflush the flowcell 5 Gently push the plunger on the cleaning syringe to flush the EZ KLEEN through the Perox flowcell 2 Repeat with deionized water 6 Reattach the sample tubing 5 to the top of the sample syringe 6 7 Refill the syringe with EZ KLEEN 8 Disconnect the shuttle line 7 from the side of the UFC 8 and place the sample tubing into a beaker to catch fluid as you backflush the flowcell 9 Gently push the plunger on the cleaning syringe to flush the EZ KLEEN through the Perox flowcell 2 Repeat with deionized water 10 Reattach the shuttle line 7 to the side of the UFC 8 11 Refill the syringe with EZ KLEEN Troubleshooting the Analyzer 12 At the Valves windo
173. appropriate incubation mix the sample again by inverting it 5 10 times or vortexing it for 5 seconds immediately before aspirating on the ADVIA 2120 21201 Hematology System Cells in prepared CSF samples will settle quickly due to low viscosity Materials Required but not Provided For the ADVIA 2120 2120i Hematology System the other materials required to perform the ADVIA 120 CSF method are the various control materials calibrators ADVIA OPTIpoint and other reagents or equipment specified in the Methods Introduction section Procedure for Running CSF Samples To run CSF samples on your ADVIA 120 Hematology System perform the following procedure Regulatory Information If the Standby indicator is lit press the Standby button to put the system into Ready to Run mode Using the Order Entry tab create a workorder for each CSF sample preparation to be analyzed Include sample physical characteristics in the Ocom field and if necessary the dilution factor in the Dil field Enter CSF as the sample type and select the Tab key in order to see the correct menu of tests At the Routine Operations menu select the Manual Sample ID tab Select the Cerebrospinal Fluid button Select Initialize to wash the pathways and obtain a flow cell background count After the system has completed the initialization cycle and the sample aspiration light is green verify that background counts in the flow cell pathway are within acceptable limits If
174. ar area PMN Ratio Ratio of the percent of the Polymorphonuclear events to the percent of NEUTS and EOS obtainedfrom the peroxidase method BASO Dead Time Percent of analysis time when the channel is busy and cannot detect flowcell events BASO Noise Percent of events from Noise area BASO Saturation Percent of events from Saturation area LI Lobularity Index Blast Percent of events from Blast area Methods Methods BASO PHA Cells B acq The total number of events in the BASO cytogram excluding the Noise area BASO PHA Total B tot The total number of events in the BASO Cytogram including the Noise area BASO Valid Cells B vc The number of valid electronic pulse signals detected from flowcell events BASO Saturation The number of events in the Saturation area 1 of the BASO cytogram BASO Count The number of cells in the Baso area 1 of the BASO cytogram 8 13 8 14 Blasts The number of events in the Blasts area 1 of the BASO cytogram PMN The number of events in the PMN area 1 of the BASO cytogram MN The number of events in the MN area 1 of the BASO cytogram Methods Methods Noise The number of events in the Noise area 1 of the BASO cytogram BASO Suspect The number of events in the Baso Suspect area 1 of the BASO cytogram RawWBC BASO Valid Cells x BASO PHA Cells BASO PHA Total BasoCalFactor The sampler specific calibration factor Ba
175. ardware failure Corrective Action a b Reset the analyzer by selecting Utilities Exerciser Indicators Analyzer Reset After about 1 minute if the status line does not display Ready to Run and the green ready to aspirate light is still off follow these steps to exit the ADVIA 2120 21201 software turn off the analyzer and then restart i Select Shut Down ADVIA in the Log On Off window ii Select Off at the analyzer touchpad iii Select CTRL ALT DELETE and log back onto the system to restart the software 7 97 7 98 iv Restart the analyzer by selecting On at the analyzer touchpad 2 Faulty power Call Siemens Service for assistance supply fuse cable Valve Driver 2 Board or Can Bus Scrambler Board Waste Container Full Waste level in the container has reached the level sensor indicating that the container is full When this error message is displayed the aspirate plate will not function nor will the Ready light illuminate Possible Cause Corrective Action 1 The waste Follow the steps in Emptying the Waste Container container is full 2 Level sensor Verify connection is secure cable is disconnected 3 Faulty level Call Siemens Service for assistance sensor WBC Substitution Alarm The number of consecutive occurrences of this condition has met the criterion specified for an alarm message The specified alarm criterion is user definable in the Customize Menu System Setup Alarm St
176. are red while cells identified as reticulocytes are cyan RETIC Scatter Cytogram The RETIC Scatter cytogram is the graphic representation of two light scatter measurements the high angle low gain light scatter is plotted along the x axis and the low angle low gain light scatter is plotted along the y axis Cells identified as mature RBCs are colored red while cells identified as reticulocytes are colored cyan Methods 8 65 8 66 Using the Mie theory of scattering for homogeneous spheres the low angle and high angle light scatter signals for each cell are transformed into volume and hemoglobin concentration values RBCs have cell volumes between 30 fL and 180 fL and hemoglobin concentrations between 19 g dL and 49 g dL Bibliography Tycko DH Metz MH Epstein EA Grinbaum Flow cytometric light scattering measurement of red blood cell volume and hemoglobin concentration Applied Optics 24 9 1355 1365 1985 Calculating Retic Parameters Reported Parameters Parameter Explanation Retic RBC x Retic 100 x 1000 Retic 100 x RETIC Count RTC Gated Cells x RETIC Cal Factor CHr Mean of the RETIC CH histogram for the reticulocyte population System Parameters The following parameters are for research or laboratory use only and are not for patient reporting Parameter Explanation RTC RBC RBC Count RTC Flatness messed Titeres 9 x Mean Cell Counting Rate RTC Dead Time 100 x Measured Dead Ti
177. ation or alteration of the computer disks and or the programs contained on such disks by the user or for any direct or indirect consequences resulting from such modification or alteration Calculation of Results The system automatically performs all calculations necessary for obtaining final results Through the use of flagging algorithms laboratory personnel are alerted to suspected abnormal conditions These conditions are indicated by the appropriate flag such as and or color highlighting Whenever a flag is triggered the user should review the results and take appropriate action NOTE The ADVIA 2120 2120i Hematology System performs all calculations using 64 bit floating point numbers IEEE standard as provided by Intel processors The number of significant digits is 14 The system rounds numbers for display to the specified number of digits in the appropriate unit set For example 4 674999999 becomes 4 67 4 675 becomes 4 68 This means that certain things might appear inconsistent such as the diff appearing to add up to 99 9 instead of 100 or the displayed value of derived results such as HCT not appearing to be correct Example 10 0 5 349 86 49 10 46 2635 is rounded to 46 3 The system displays the values 5 34 86 4 10 which equal 46 1 Interpretation of Results System operators and laboratory supervisors are responsible for operating and maintaining Siemens products in acco
178. autoslide critical error Check message log for other errors software error unrecognized correct problem reset autoslide see version emergency stop Tip 2 communications bad parameter EEPROM error not initialized sync error sample may be diluted hardware error autoslide interface error command timeout command status Run stopped if Alarm Stop criteria set ASL Dispenser error Failure Mechanical problem on dispenser Inspect dispenser area Look for stuck or broken slide Ensure sufficient slides are loaded to cover both slide sensors proceed to Tip 2 ASL EEPROM error Failure EEPROM read or write error Call Siemens during initialization ASL EEPROM IO error Failure An error occurred when reading or Perform Mechanical Initialization to updating the EEPROM reset autoslide Cycle power to Autoslide if problem persists and call Siemens ASL Emergency stop Failure Cover may have been opened Close cover and reset autoslide See cycle while autoslide was busy Tips 2 amp 3 ASL Hardware error Failure A hardware error has occurred Check message log for other errors correct problem reset autoslide see Tip 2 Call Siemens 10 48 ADVIA Autoslide Slide Maker Stainer Event Text Severity Probable Cause Suggested Action ASL Impossible to rinse Failure Unable to rinse sample or drop Perform a mechanical initialization If deposit lines
179. ay run a retained patient sample periodically to monitor performance trends Regulatory Information 9 59 9 60 Results The system automatically performs all calculations necessary for obtaining final results Through the use of complex flagging algorithms laboratory personnel are alerted to suspected abnormal conditions These conditions are indicated by the appropriate flag such as and or color highlighting Whenever flags occur the user should review the results and take appropriate action Limitations of the Procedure The limitations of the procedure are as listed 1 When assaying samples with extremely elevated counts the reticulocyte method may give reticulocyte counts that differ significantly from NCCLS manual counts Extremely elevated counts are often seen in samples that contain sickled cells or nucleated RBCs 2 Samples from patients having the following cell types or conditions may interfere with the ADVIA 120 Reticulocyte method Malarial parasites Pappenheimer Bodies Howell Jolly Bodies Heinz Bodies Inclusions that give rise to basophilic stipling Macrothrombocytes giant platelets Megaloblastic anemia Other rare poorly characterized red cell anomalies Expected Values The range of expected values can vary depending on age sex diet and location It is recommended that each laboratory establish its own range of expected values The following range of expected values is based upon the du
180. back into position 11 Tighten the clamp screws ADVIA Autoslide Slide Maker Stainer 10 19 12 Replace and connect all lines disconnected in steps 4 8 13 When the reconnection is complete turn the ADVIA 2120 21201 system back on The Autoslide icon turns grey Wait until the Autoslide established communication with the analyzer The icon goes from grey to orange and then to green Do not initiate any command until communication is established and the icon for the Autoslide is green Autoslide Methods May Gr nwald Giemsa Method Intended Use The May Gr nwald Giemsa method is for in vitro diagnostic use in the differential staining of blood bone marrow and body fluid smears on the ADVIA Autoslide Slide Maker Stainer Stained smears are evaluated to identify and quantify cells in whole blood and other specimens to aid clinicians in the assessment of various clinical conditions Summary and Explanation The reagent protocol for the ADVIA Autoslide Slide Maker Stainer consists of a modified methylene blue eosin stain and is based on the original stain proposed by Pappenheim The ADVIA Autoslide Slide Maker Stainer is a smart fully automated system It is capable of producing stained smears on all specimens run on the ADVIA 2120 21201 or only on samples with predefined criteria i e flags or parameter threshold The autoslide module also provides a direct access port to the stainer for pre smeared slides Staining Protocol
181. be size mm Draw Required diameter x height Manufacturer Vol mL Dead Vol mL 10x 50 Becton Dickinson 0 6 VACUTAINER 10 x 64 Venoject 0 6 11 x 65 Sarstedt Monovette 2 7 1 0 11x74 Tapval 4 1 1 11x78 screw cap 4 1 2 11 x 83 Sarstedt Monovette 4 1 0 11x91 Sarstedt Monovette 5 1 0 12x 75 6 Greiner Vacuette 2 4 1 0 12x 80 screw cap 1 1 12 x 80 7 Exetainer 3 1 0 13 x 100 Becton Dickinson 7 0 8 HEMOGARD 13 x 100 Greiner Vacuette 6 13x 74 Monoject 5 0 6 13 74 Complexon 5 0 8 13 75 Becton Dickinson 2 3 5 0 8 HEMOGARD 13 75 Becton Dickinson 7 0 6 VACUTAINER 13 75 Becton Dickinson 5 0 6 VACUTAINER 13x 75 Lip Vac 4 13 78 Venoject II 5 1 5 Some of the allowable tube closure types e Standard VACUTAINER e HEMOGARD e Center puncture Safety Monovette Welcome to the ADVIA 2120 2120i Hematology System e Venoject II Manual Closed and Open tube Samplers HJ pj 2 Lx Single samples and STAT samples are aspirated from the manual samplers In closed tube aspiration the capped vial is inserted upside down into the centering collar 1 The downward pressure of inserting the tube into the centering collar will cause the needle to push up puncture the tube closure and aspirate a sample In open tube aspiration the sample probe 2 is immersed into the specimen Pressing the push to aspirate plate 3 starts the sampling
182. bers of 5 Check the pressure and vacuum readings NRBCs Retic Absorption Flatness RTC FL RF Definition The Retic Absorption Flatness flag is triggered when the CV coefficient of variation for the RETIC ABS Flatness histogram is greater than 3 6 Results Flagged RETIC CHg CHr CHCMg CHCMr CHDWr CHDWg MCVg MCVr RDWg RDWr Corrective Action Laser oscillation mode hopping Laser oscillation also called mode hopping is defined as a change in the laser output frequency during the analysis Typically this condition triggers three sample system flags e RETIC Fit Suspect flag RTC FS is triggered due to the bimodal absorption populations that appear on the RETIC Scatter Absorption cytogram 1 and the RETIC Absorption histogram 2 e RETIC Absorption Distribution Abnormal flag RTCADA is due to the bimodal absorption populations that appear on the RETIC Absorption histogram 2 RETIC Absorption Flatness flag RTC FL is triggered due to the large variation in absorption signals that appears on the RETIC ABS Flatness histogram 3 In such cases the operator must rerun the sample Flags Flags Retic Fit Suspect RTC FS FC Definition The Retic Fit Suspect flag is triggered if e There is more than a 15 difference between the mean and the mode of the Gaussian fit of the RETIC Absorption Histogram e The chi square error for the Gaussian fit exceeds 80 000 Results Flagged
183. bes to fall behind the aspirate paddle assembly If necessary use hemostats to hold the tubing outside the assembly Connect the lines to the new block Install the block onto the aspirator assembly by aligning the tabs with the appropriate slots Push the block into the assembly and gently slide the block upward until it clicks into place Be careful that you do not pinch the wash or vacuum line during the installation process Check the length of the probe See page 5 3 for instructions Run several saline samples and verify that there are no leaks or bubbles in the sample line Run a whole blood primer to verify that the probe is being properly washed and dried after aspiration 10 Run controls to verify analyzer performance Troubleshooting the Analyzer Troubleshooting Tips Autosampler Troubleshooting Tips Eject rack or Rack in sampler status line error messages appear when the analyzer is powered off then turned on again To avoid autosampler errors you should wait for the following two status line messages to appear before you turn the power on again Communication error with analyzer Analyzer computer not connected There is leakage at the sample fitting on the centering collar Finger tighten the fitting about 12 turns then use a 7 32 inch 6 mm open end wrench to tighten the fitting another 1 8 turn The error message Input queue gate open appears occasionally when starting t
184. ble in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Alarm Criteria is automatically reset Corrective Action Verify printer connections and operation Typical printer problems include e Paper jams Out of paper e Printer offline e Printer disconnected Printer Problem Stop A printer problem has occurred The number of consecutive occurrences of this condition has met the criterion specified for a stop message The specified stop criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Stop Criteria is reset when the Start Stop button is selected Corrective Action Verify printer connections and operation Typical printer problems include e Paper jams e Out of paper e Printer offline e Printer disconnected Probe Clog Conductivity detector did not detect a sample within twenty seconds of aspiration Possible Cause Corrective Action 1 Clogged Check for sample clots sample 2 Insufficient Sample tube may have been removed before aspiration sample volume was complete Re aspirate sample If error persists clean the sample shear valve Status Line messages Insufficient vacuum Clogged clot filter Loose connection in sample line Clogged needle Bent or damaged needle Faulty Conductivity Detector Check vacuum gauge and adjust if necessary Remove clot filter and discard as biohazardous mater
185. block 7 46 Status Line messages 2 The same test code is used Remove the duplicate test codes from the twice in the par file par file in Tools Modify DEFOAMER Reagent Empty Stop The number of consecutive occurrences of this condition has met the criterion specified for a stop message The reagent is empty and the autosampler has halted The specified stop criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria Reagent Conditions Corrective Action The stop counter is automatically reset after reagents are replenished and the Reagent Installation window is updated Go to Logs Reagent Log Reagent Installation Select Start Stop to continue the run DEFOAMER Reagent Expired Present date is beyond the DEFOAMER reagent expiration date as determined by encoded reagent container barcode label or as calculated from installation date and open container stability Corrective Action Replenish expired reagents and update the Reagent Installation window Go to Logs Reagent Log Reagent Installation DEFOAMER Reagent Low Alarm The number of consecutive occurrences of this condition has met the criterion specified for an alarm message indicating the reagent level is low The specified alarm criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria Reagent Conditions Corrective Action The alarm counter is automatically reset after reagents are replenished and the
186. boratory safety Small amounts of stain may overflow from the stainer wells This overflow is collected in a tray located on the side of the Autoslide beneath the stainer module To clean the stain overflow tray 1 Using both hands carefully pull out the tray located under the stainer module and remove it 2 Using a cloth or paper towels dampen with a 10 solution of bleach and wipe the tray clean 3 Let the tray air dry then replace it securely under the stainer module ADVIA Autoslide Slide Maker Stainer 10 39 10 40 Performing Weekly Shutdown and Startup The weekly shutdown provides a thorough cleaning of the fluidics circuit and must be performed once a week Failure to perform the shutdown procedure regularly can result in line clogs TOXIC Methanol is toxic To avoid serious irreversible effects do not inhale do not contact with skin and do not swallow Wear suitable protective clothing and gloves In case of accident or if you feel unwell seek medical advice immediately FLAMMABLE Methanol is flammable Keep away from sources of ignition no smoking To perform a weekly shutdown 1 On ADVIA 2120 21201 software menu select Procedures then select Clean Autoslide The Clean Autoslide window opens 2 Select Weekly Shutdown and follow the instructions displayed on the window to perform a weekly shutdown 3 When the weekly shutdown completes you must perform a weekly startup before sli
187. cally reset RETIC Fit Suspect Stop The number of consecutive occurrences of this condition has met the criterion specified for a stop message The autosampler halts at the same time the stop message occurs The specified stop criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Stop Criteria is reset when the Start Stop button is selected RETIC Irregular Flow Rate Alarm The number of consecutive occurrences of this condition has met the criterion specified for an alarm message The specified alarm criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Alarm Criteria is automatically reset RETIC Irregular Flow Rate Stop The number of consecutive occurrences of this condition has met the criterion specified for a stop message The specified stop criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Stop Criteria is reset when the Start Stop button is selected Status Line messages RETIC Noise Origin Alarm The number of consecutive occurrences of this condition has met the criterion specified for an alarm message The specified alarm criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Alarm Criteria is automatically reset RETIC Noise Origin Stop The number of consecu
188. ccess the potentiometer adjustment screw on the Hgb Power Supply Preamp PCB Potentiometer 1 on the Hgb Power Supply Preamp Board 4 Select Start Cycle As the analyzer is checking the baseline value use a small screwdriver to turn the adjustment screw so that the Current value is 4 1 To increase the value turn the screw clockwise To decrease the value turn the screw counterclockwise 5 Select Exit and replace the plastic plug Troubleshooting the Analyzer Adjusting the Length of the Sample Probe After each aspiration the wash block 1 is lowered and the probe is washed within the block For a proper wash the terminal end of the probe 2 must be between the upper 3 and lower 4 ports of the wash block when the block is at its lowest position CORRECT PROBE ALIGNMENT PROBE MUST BE REPLACED PROBE ALIGNMENT REQUIRED 4 2 4 4 2 1 Look at the terminal end of the probe in the lowered wash block If the probe is too short it must be replaced 2 Ifthe probe is too long remove the probe and using a sharp scalpel or a single edged razor blade cleanly cut the probe to the appropriate length Be very careful to make the cut straight without burrs Do not cut the probe on an angle 3 Replace the probe and check the length Adjusting the Pneumatic Regulators 1 To gain access to the knobs snap open the white panel on the right side of the analyzer Using a Phillips head screwdriver remove the small green
189. ce for assistance in modifying the parameter file NULL Number Max of Rerun Not Defined The number of authorized reruns is not defined in the parameter file Status Line messages 7 65 7 66 Corrective Action Using the Customer Parameters window define the parameter Max Number of Automatically Proposed Reruns to specify the maximum number of reruns proposed by the Data Manager NULL Status Modified The status of the specified sample has been modified Corrective Action No operator action required Open Port Error A software preparation initialization error has occurred Corrective Action 1 2 Select Shut Down ADVIA at the Log On Off window Select CTRL ALT DELETE and log back onto the system to restart the software If the error recurs select Customize menu System Setup Tools Modify Port Configuration Verify that the Inst1 device is listed as ADVIA 2120 2120i and correct it if necessary Check the communications port where the problem occurs COM 1 or MCA Serial board If the system is using the Host Spec 79 Network connection Siemens Field Service personnel should make sure the Host name and IP address are specified correctly 1 Use Windows Explorer to open the directory C WINNT system32 drivers etc Double select Hosts In the Open with box select Notepad and select OK At the bottom of the document verify the host IP address and the host computer name match those supplied by th
190. cell and the CFM 5 Clean the glass windows of the flowcell 6 Replace the flowcell Troubleshooting the Analyzer 5 13 5 14 7 Check analyzer performance See below for detailed steps Cleaning the Flowcells off the Analyzer Step 1 Removing the Perox Flowcell 1 Make sure that the analyzer is in the Standby mode 2 Open the optics cover The perox flowcell is on the left Perox flowcell 1 RBC flowcell 2 3 Disconnect the shuttle line 1 the sample stream input line 2 and the sheath stream input line 3 from the CFM Allow these lines to hang freely 1 SHEATH NIPPLE 2 SAMPLE NIPPLE 3 SHUTTLE NIPPLE 1 3 2 4 Locate hydraulic valve 24 Unscrew the threaded fitting from the top right side of the valve Troubleshooting the Analyzer To Waste Reagent UFC 5 Release the flowcell by loosening the release knob located on right of the flowcell adjustment assembly Flowcell release knob 1 gt Front of analyzer 6 Hold the flowcell by the red threaded fitting located at the top of the flowcell then gently lift the flowcell out of the optics assembly AN To avoid getting fingerprints on the glass windows of the flowcell always hold the flowcell by the metal slides Cleaning the Flowcells off the Analyzer Step 1 Removing the RBC BASO Retic Flowcell Before you begin the cleaning of the RBC baso retic flowcell read all laser safety precautions Tr
191. ch nipple separately the other two nipples have to be blocked off To do this knot a piece of 0 020 0 5 mm ID tubing in the middle of its length Attach the two ends of the tubing to the nipples that are not being flushed 3 Draw 10 mL of 25 solution of household bleach and water into the syringe Connect the syringe and adapter to the flowcell tube assembly fitting 4 Working over a sink carefully press the plunger to push the contents of the syringe into the flowcell and out the open nipple 5 Switch one end of the knotted tubing to the cleaned nipple 6 Disconnect the syringe and the adapter and draw 10 mL of the appropriate fluid into the syringe Flush the flowcell with the fluid now exiting through the second nipple 7 Repeatthe flushing for the third nipple 8 Repeat steps 2 through 7 using water to rinse out the flowcell and the CFM 9 Disconnect the syringe and adapter from flowcell tube assembly fitting Cleaning the Flowcells off the Analyzer Step 5 Cleaning the Glass Windows of the Flowcell 1 Fold a piece of lens tissue so that one edge is slightly narrower than the optical glass window AN CAUTION To avoid getting material from your hands onto the optical surfaces glass windows do not touch the area of lens paper that will come in contact with the glass windows 2 Soak this edge of the tissue paper with methanol Troubleshooting the Analyzer 5 19 5 20 5 AN CAUTION Since
192. chpad select Off reader cabling b Wait about minute and select On to restart the analyzer If the problem persists call Siemens Service for assistance 7 36 Status Line messages 2 Faulty barcode reader 3 Window of barcode reader is dirty or line of sight is obstructed 4 Rack barcode label improperly placed obscured or absent See la b Clean barcode reader window b Make sure there is no visual obstruction between the barcode reader window and the rack If problem persists call Siemens Service for assistance Make sure the barcode label is correctly placed on the rack is clean and meets specifications Autosampler Rack Scan Failed Barcode reader is unable to scan Possible Cause 1 Faulty barcode reader cabling 2 Faulty barcode reader Corrective Action At the analyzer touchpad select Off b Wait about minute and select On to restart the analyzer If the problem persists call Siemens Service for assistance See la b c Autosampler Shuttle Gate Open Input queue cannot advance the rack because the shuttle gate is not closed Possible Cause 1 Shuttle gate only partially closed 2 Faulty sensor or sensor wiring Status Line messages Corrective Action Check for an obstruction to the shuttle gate b Push the shuttle gate to check for spring resistance AN CAUTION Call Siemens Service for assistance Only Siemens Service per
193. cimen was stored at 2 C to 8 C in capped blood collection tubes that contained EDTA as the anticoagulant The results indicate that RETIC parameters are stable within 2 standard deviations within run precision of the initial recovery for the specified time interval The stability of calculated parameters is limited to the stability of the least stable primary parameter Parameter Room Temperature Refrigerated Temperature Stability hours Stability hours 24 72 CHr 24 72 Materials Required but not Provided For ADVIA 2120 2120i Hematology System the other materials required to perform the ADVIA 120 reticulocyte method are the various control materials calibrators ADVIA OPTIpoint and other reagents or equipment specified in the Methods Introduction section Procedure To run samples on your ADVIA 2120 2120i Hematology System refer to the Daily Routine Regulatory Information Quality Control It is recommended that the system be controlled using ADVIA TESTpoint Reticulocyte Controls These controls are intended to be integrated into a clinical laboratory s own quality control program and procedures Control materials should be assayed e At the beginning of each shift or at some other interval chosen by the laboratory e After a reagent lot number change e After replacement of any part or component of the analytical module that may affect analytical performance As an option laboratories m
194. criterion specified for an alarm message indicating the reagent level is low The specified alarm criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria Reagent Conditions Corrective Action The alarm counter is automatically reset after reagents are replenished and the Reagent Installation window is updated Go to Logs Reagent Log Reagent Installation Status Line messages File Does Not Exist A patient or control result printout has been selected in the Routine Parameters window But one of the files Report par Prevalid par Print par or QCreport par is not defined Corrective Action Restore dictionaries in Other Utilities window File Not Found C Wst Oen cnf The default workorder screen configuration file is missing Corrective Action Continue to create workorders in Order Entry as needed To restore the Oen cnf file select Other Utilities and restore dictionaries File Not In Modifiable File List Updating This message appears when a file is created through the Format window The file is then stored in the database Corrective Action No action is required GETEQUAL This control is not defined in the Control Dictionary Corrective Action Define the control in the Control Dictionary GlobalLock or GlobalUnlock The selected dispositions cannot be stored because the sample record is full Corrective Action Reduce the number of dispositions selected or cancel the se
195. currences of this condition has met the criterion specified for a stop message The autosampler halts at the same time the stop message occurs The specified stop criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Stop Criteria is reset when the Start Stop button is selected Review Mode Change to Review None The validation mode has been modified through the Parameters menu in the Review and Edit window Status Line messages Running Displayed after pressing the autosampler Start Stop button or during sample processing Possible Cause Corrective Action If the system halts a Reset the analyzer by selecting Utilities Exerciser in the Running Indicators Analyzer Reset state there could b After about 1 minute if the status line does not bea hardware or display Ready to Run and the green ready to aspirate software failure light is still off follow these steps to exit the ADVIA 2120 2120i software turn off the analyzer and then restart i Select Shut Down ADVIA at the Log On Off window ii Select Off at the analyzer touchpad iii Select CTRL ALT DELETE and log back onto the system to restart the software iv Restart the analyzer by selecting On at the analyzer touchpad gt Sample ID Not Read Alarm Sample tube barcode label is unreadable or missing The number of consecutive occurrences of this condition has met the criterion specified for an ala
196. d 1 2 3 4 Analyzer mode Off Checkout 15 minutes DP1 PEROX SHEATH DP2 SHEATH RINSE DP3 SHEATH RINSE DP4 WASH PN 067 B294 04 DP5 SHEATH RINSE PN 067 B294 01 111111 REMOVE BOTTLES ACCESS DIAPHRAGM PUMPS i it 171 Remove the reagent bottles from the side where you are replacing the diaphragm pump Pull the pump forward until it is released from its keyhole slots Remove the three tubes then attach these tubes to the new pump Insert the raised studs on the top of the pump into the keyholes and push the pump back until it is secure Replace the reagent bottles Checkout gt For all replaced pumps prime reagent lines and verify that there are no leaks Troubleshooting the Analyzer 5 V34 4 V60 3 V29 2 V28 gt If DPI is replaced run two saline primers At the Operations menu select the Startup tab Select Refresh and verify that the WBC background count is 0 1 or less 1000 cells uL If DP4 is replaced do a system wash and verify that the reaction chambers are filling up with wash solution to their normal wash levels If DP5 is replaced run two saline primers At the Operations menu select the Startup tab Select Refresh and verify that the platelet background count is 5 or less 1000 cells uL If required run additional saline samples until acceptable background counts are obtained for two consecutive samples If more than five s
197. d Cells x RBC Cal Factor x Dilution Factor x Coincidence correction Factor MCV Mean of RBC Volume histogram RDW 100 x SD of RBC Volume histogram MCV CHCM Mean of RBC HC histogram HDW SD of RBC HC histogram Methods 8 49 8 50 CH HCT MCH MCHC Mean of RBC CH histogram RBC x MCV 10 HGB RBC x 10 HGB RBC x MCV x 1000 Additional Parameters The following parameters are for research or laboratory use only and are not for patient reporting Parameter CHDW RBC Flatness RBC Dead Time RBC Coin Level RBC Coin Count RBCR Count RBC P Count RBC Valid Cells MICRO MACRO MICRO HY PER SD of RBC CH histogram Sum of theSquared Differences 9 x Mean Cell Counting Rate 100 x Measured Dead Time Measured Sample Time Number of coincidence events to be trimmed Coincidence Count in RBC Scatter cytogram Number of RBCs in RBC Scatter cytogram Number of platelets in RBC Scatter cytogram Number of Valid Signals Obtained from Flowcell Events Cell Count 30 fL to 60 fL in RBC Volume histogram Cell Count in RBC Volume histogram gt 120fL Total Cell Count in RBC Volume histogram 100 x Cell Count in RBC Volume histogram lt 60fL Total Cell Count in RBC Volume histogram 100 x Cell Count RBC HC histogram gt 41g dL Total Cell Count in RBC HC histogram 100 x Cell Count RBC HC histogram lt 28g dL Total C
198. d as a patient result MN PMN Threshold The valley threshold shown as a red line separates the Mononuclear MN and Polymorphonuclear PMN populations The valley threshold is a floating threshold that is set using the Baso X histogram Abnormal Cell Locations If abnormal cells are present their size and nuclear configuration determine the location of their signals on the BASO cytogram Click the cytogram buttons below to see where the abnormal cells will appear Location of Blasts on the BASO Cytogram Blasts appear in the Blast area 1 on the BASO cytogram 8 9 8 10 Location of Atypical Lymphocytes on the BASO Cytogram 1 Atypical Lymphocytes appear within the mononuclear MN area 1 on the BASO cytogram Immature Granulocytes appear within the MN area on the BASO cytogram Nucleated Red Blood Cells NRBCs appear within the PMN population on the BASO cytogram However NRBCs are identified for flagging purposes in the peroxidase method The system uses data from the perox channel and the baso channel to derive the Nucleated Red Blood Cell NRBC count 7NRBC and NRBC If NRBCs are present the system corrects the WBC results to account for them Methods Methods Location of Bands on the BASO Cytogram Bands appear between the mononuclear MN and polymorphonuclear PMN populations Calculating Parameters Reported Parameters The following parame
199. d in the following Table Sample Stability Expected Imprecision Correlation Data Observed Analytical Range Room Temp Refrigerated Values Mean SD CV y r Sy x Carryover Range Deviation RETIC 24h 72h 0 8 to 2 1 1 2 0 16 13 3 0 82x 0 2 0 925 0 4 0 2 to 24 9 2 6 10 L 40 to 79 57 8 7 7 13 3 0 79x 7 8 0 903 13 6 CHr pg 24h 72h 24 to 36 28 9 0 2 0 7 0 96x 4 2 0 940 1 7 RTC RBC Count 1 0 not available or not applicable for this parameter Regulatory information 9 65 ADVIA Autoslide Slide Maker Stainer OVER VIEW eo Lan ao opea sae eee 2 LOADING REAGENTSS ep sa e eoe 11 LOADING SLIDE RACKS 5 ee oin so ee poh snae 68866 area a0 eo Fase ee rp a eL oco Un eoe ad ao 12 LOADING SLIDES RO Hu gen 12 EMPTYING THE STAIN WASTE CONTAINER eee eee e eee 13 RUNNING THE DAILY STARTUP MANUALLY 13 ORDERING A SLIDE MANUALLY ee ee ee eee eee eno esten esee 14 STAINING MANUALLY SMEARED SLIDES 1 nate ette 14 RESETTING THE AUTOSLIDE MODULE eee ee ee ee ee ee eoo e eee to nee ee toes etta au 14 STOPPING THE AUTOSLIDE MODULE FAST STOP e eeee eere eneee 15 RUNN
200. de 0 11 Buffer For in vitro diagnostic use 9 24 Regulatory Information ADVIA 120 HGB PN T01 3628 01 2 x 1100 mL ADVIA 120 HGB contains Potassium cyanide 23 mmol L Dimethyl laurylamine oxide 2 0 HARMFUL Harmful by inhalation in contact with skin and if swallowed Avoid contact with skin and eyes Wear suitable protective clothing and gloves In case of accident or if you feel unwell seek medical advice immediately show the label where possible Do not empty into drains R20 21 22 524 25 529 536 37 545 For in vitro diagnostic use ADVIA 120 BASO PN T01 3629 01 2 x 1100 mL ADVIA 120 BASO contains Hydrochloric acid 9 00 mmol L Phthalic acid 21 49 mmol L Preservative Surfactant For in vitro diagnostic use ADVIA 120 CN FREE HGB PN 01 4288 01 2 x 1100 mL ADVIA 120 CN FREE HGB contains Dimethyl laurylamine oxide 2 0 For in vitro diagnostic use ADVIA 120 SHEATH RINSE PN T01 3664 01 1x 10L PN T01 3623 01 1 x20L ADVIA 120 SHEATH RINSE contains Preservatives Buffers Surfactant Regulatory Information 9 25 For in vitro diagnostic use Storage and Stability Reagents When stored between 15 C and 30 C e All unopened reagents are stable until the expiration date printed on the product label e Opened containers of ADVIA 120 BASO reagent ADVIA 120 HGB reagent and DEFOAMER are stable for 90 days e Opened containers of ADVIA 120 SHEATH RINSE and ADVIA 12
201. de production can resume If you want turn the system off after the Weekly Shut Down wait until you are ready to run more samples before performing the Weekly Startup 4 Atthe Clean Autoslide window select Weekly Startup 5 Follow the instructions displayed on the window to perform a weekly startup Cleaning the Stainer Wells and Plate BIOHAZARD All products or objects that come in contact with human or animal body fluids should be handled before and after cleaning as if capable of transmitting infectious diseases Wear facial protection gloves and protective clothing The operator should follow the recommendations to prevent the transmission of infectious agents in health care settings as recommended for potentially infectious specimens in Protection of Laboratory Workers from Infectious Disease Transmitted by Blood Body Fluids and Tissue 2d edition Approved Guideline 1997 Document M29 A National Committee for Clinical Laboratory Standards NCCLS This document contains complete information on user protection and it can be used as reference material for instructions on laboratory safety ADVIA Autoslide Slide Maker Stainer Materials required e Methanol e Laboratory tray e Paper towels Time 15 minutes Analyzer mode Standby NOTE It is recommended that the stainer wells be replaced once a year Check the Replaceable Parts section of the Operator s Guide for ordering information e TOXIC Methanol is toxic
202. der if the slide does not rest on the bottom peg it may break Close the manual STAT inlet door When the system is ready to process the slide the manual cycle starts this may take up to 30 seconds The slide is transferred to the staining assembly and the staining operation begins At the end of the cycle the slide is loaded into a rack and the manual inlet door opens Insert the next manually smeared slide If you have no more slides to stain close the manual STAT inlet door Return to normal analyzer and autoslide operation Resetting the Autoslide Module The Reset Autoslide button displays on some autoslide related software tabs and windows most notably the Autoslide Control tab at the Operations menu 10 14 ADVIA Autoslide Slide Maker Stainer Click this button to reset the Autoslide module This function is intelligent and will reset only those autoslide mechanisms that require resetting This may be necessary when troubleshooting Autoslide module errors Depending on the state of the system this may take up to 16 minutes Stopping the Autoslide Module Fast Stop The Fast Stop button displays on some autoslide related software tabs and windows most notably the Autoslide Control tab on the Operations menu Click this button to immediately stop the Autoslide module Any slides that are in the stainer will be lost when a Fast Stop occurs When a Fast Stop occurs you must perform a Stainer Evacuation before return
203. died over a 72 hour period on the ADVIA 120 Hematology System Two whole blood specimens drawn from 15 normal apparently healthy donors were assayed shortly after phlebotomy and then again at intervals of 8 24 36 48 56 and 72 hours One of the whole blood specimens from each pair was stored at room temperature while the corresponding specimen was stored at 2 C to 8 C in capped blood collection tubes that contained EDTA as the anticoagulant The results indicate that WBC DIFF parameters are stable within 2 standard deviations within run precision of the initial recovery for the specified time interval Parameter Room Temperature Refrigerated Temperature Stability hours Stability hours NEUT 36 72 LY MPH 36 72 MONO 2 72 EOS 8 72 BASO 72 56 LUC 72 72 Materials Required but not Provided For ADVIA 2120 2120i Hematology System the other materials required to perform the ADVIA 120 WBC DIFF method are the various control materials calibrators ADVIA OPTIpoint and other reagents or equipment specified in the Methods Introduction section Regulatory Information Procedure To run samples on your ADVIA 2120 2120i Hematology system refer to the Daily Routine Quality Control It is recommended that the system be controlled using ADVIA TESTpoint Hematology Controls Please refer to page 9 5 for product descriptions These controls are intended to be integrated into a clinical laboratory s own quality contr
204. e Repair and Replacement Replacing the Clot Filters Materials required Time Replacement 5 minutes Analyzer mode Standby Lens tissue Replacement clot filter PN 113 3719 01 Checkout 5 minutes Gently push the silicone sleeve 3 to release the clot filter 4 from the filter adapter fitting 5 Visually check the filter adapter fitting and the input port of the selector assembly for any dirt or small particles If you find some debris use a piece of lens tissue moistened with water to remove it Troubleshooting the Analyzer 5 25 5 26 Wet the new clot filter with water and place it into the filter adapter fitting Orientation of the filter is not important Reconnect the filter adapter fitting to the selector valve Finger tighten IMPORTANT Be very careful not to misthread the fitting Misthreading could strip the valve which will prevent proper operation Run a sample and visually check for air bubbles in the sample line between the selector valve and the UFC block Check aspiration rate If air bubbles appear check that the filter adapter fitting is screwed on correctly and that it is finger tight then repeat step 7 If air bubbles still appear disconnect the filter adapter fitting and check for dust or debris in the fitting and in the port If air bubbles still persist call Siemens technical support Replacing the Diaphragm Pumps Time Replacement 5 minutes Materials require
205. e Quality Control Gain Adjustment Regulatory Information 9 13 9 14 Calibration Results Limitations of the Procedure Expected Values Performance Characteristics Available from the National Committee for Clinical Laboratory Standards 940 West Valley Road Suite 1400 Wayne PA 19087 1898 System Method Information Intended Use This topic contains a brief statement of intended use for the assay as an in vitro diagnostic procedure for quantitating analytes in human whole blood System Method Information Principles of the Procedure This topic provides a physical chemical and or biological explanation of the assay and a brief description of the reactions where applicable System Method Information Reagents These topics describe the reagents required to perform the assay including reagent packaging information product descriptions materials required but not provided and reagent preparation instructions The following briefly explains the significance of signal words used throughout these topics CAUTION Indicates a hazard that could cause illness burns skin reactions and so on This hazard is assigned to substances such as diluted acids mild caustics minor skin irritants or combustible materials ATTENTION Indicates that a specific risk exists to the user or performance NOTE Indicates additional information that is useful for the proper operation of the system NOTE The customer must maintain a c
206. e being turned container vacuum line off 1 waiting for the vacuum to dissipate and then reconnecting the line 2 Vacuum line Reconnect or remove any crimps from the waste attached to th container vacuum lines waste container At the analyzer touchpad select Off is disconnected Wait at least 1 minute and select On to restart the or crimped analyzer 3 Vacuum pump Replace the vacuum pump filter filter vacushield is clogged 4 Compressor Call Siemens service for assistance failure Control Out of Range Alarm One or more control samples have yielded out of range test results The number of consecutive occurrences of this condition has met the criterion specified for an alarm message The specified alarm criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria Control Out of Range Stop One or more control samples have yielded out of range test results The number of consecutive occurrences of this condition has met the criterion specified for a stop message The autosampler halts when the stop message occurs The specified stop criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria Could Not Attempt Location of a Workorder Exception Occurred A sample workorder could not be located because of a software error Corrective Action Status Line messages 7 45 The default selectivity has been applied for the affected sample Rerun the sample
207. e Any high current event that causes one of these fuses to fail can damage the other one and shorten its service life 5 Always replace a fuse with one of the same type and rating If the fuse label is missing or illegible refer to the fuse information table Be sure to select the fuse requirements appropriate for your system s input voltage Warnings and Safety Information Explanation of the warning labels on the manual closed tube sampler Sampler Door Manual Closed Tube Sampler Never put your finger into the To avoid injury when removing manual closed tube sampler or replacing the manual closed centering collar tube sampler needle or centering collar the system must be off You must place a protective cover over the needle immediately after removing the centering collar Warnings and Safety Information B 11 Protecting yourself from lasers The ADVIA 2120 2120i Hematology System is classified as a Class I laser product as defined by the National Center for Devices and Radiological Health CDRH regulations 21 CFR 1040 and by EN 60825 RBC laser optical assembly The RBC laser optical assembly is classified as a Class II laser device which has a maximum power output of 800 uW at 670 nm nominally and a continuous wave output The RBC laser assembly is set internally to have a maximum output of 290 58 uW The laser beam path is enclosed in a series of non interlocked protective housings that prevent human access to la
208. e wedge The waiting time drop size smearing speed and angle of the wedge are all user adjustable The system then pulls the slide back producing the smear After smearing the system raises the smearing head and the smearing tape moves to ready clean section for the next slide 3 The slide enters the printer which can print patient demographics or other information directly on the slide 4 After printing the slide moves into the verticalizer which transfers it to a staining well or directly to a rack as required 5 If staining is required the slide moves into the stainer a rotating tray containing 32 staining wells A needle plate supports needles at adjustable locations to dispense liquids into the wells or to aspirate liquid from the wells The slide is stained according to the staining method in use 6 Once staining is complete the slide is transferred to a rack and processing is complete 10 10 ADVIA Autoslide Slide Maker Stainer Autoslide Daily Routine 1 2 Check the level of the stain waste container Empty the container if necessary Check the levels and expiration dates of the autoslide reagents Load reagents if necessary Remember to prime the lines for any new reagent Check the water level if your system uses it Load slides and racks Check smearing tape status and replace if necessary If the system is not set to perform the daily startup cycle automatically perform the daily startup proced
209. e Red Cell Distribution Width RDW parameter is the coefficient of variation of the cell volume distribution on the RBC volume histogram Default trigger values for the three severity levels are RDW 16 0 to 17 9 RDW 18 0 to 22 0 RDW gt 22 0 Flags Results Flagged none Possible Causes The following list of sample related causes may not contain all conditions that could cause this flag Multiple occurrences of this flag especially for consecutive samples can indicate a system problem However isolated instances of this flag are usually sample related Sample Related System Related e Microcytic anemia 1 Check the RBC reagents Macrocytic anemia Check the RBC hydraulics e ron deficiency anemia Check the RBC gain response to iron therapy Xx opp Check the laser flowcell alignment e Transfusion Atypical Lymphocytes ATYP Definition The presence of atypical lymphocytes is suspected An elevated LUC value on the Perox cytogram may be due to the presence of large atypical lymphocytes blasts and or other large abnormal cells that are peroxidase negative Large lymphocytes are defined as those that are larger than the typical lymph population Blasts are classified independently on the Baso cytogram When the 7 BLASTS is subtracted from the elevated LUC value the remaining percentage is due to atypical lymphocytes This flag is triggered if LUC is 4 5 or greater and the LUC is
210. e Stop Criteria is reset when the Start Stop button is selected Status Line messages RBC Irregular Flow Rate Alarm The number of consecutive occurrences of this condition has met the criterion specified for an alarm message The specified alarm criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Alarm Criteria is automatically reset RBC Irregular Flow Rate Stop The number of consecutive occurrences of this condition has met the criterion specified for a stop message The autosampler halts at the same time the stop message occurs The specified stop criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Stop Criteria is reset when the Start Stop button is selected RBC Reagent Empty Stop The number of consecutive occurrences of this condition has met the criterion specified for a stop message The reagent is empty and the autosampler has halted The specified stop criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria Reagent Conditions Corrective Action The stop counter is automatically reset after reagents are replenished and the Reagent Installation window is updated Go to Logs Reagent Log Reagent Installation Select Start Stop to continue the run RBC Reagent Expired Present date is beyond the RBC reagent expiration date as determined by encoded reagent c
211. e and Brij 35 in combination with thermal stress lyse the red blood cells Formaldehyde fixes the white blood cells The hypertonic environment causes some shrinkage and crenation of the white cells This increases the refractive index of the cells and enhances the detection of lymphocytes over noise 8 25 8 26 ADVIA 2120 2120i PEROX 2 NOTE For more detailed information on the contents of ADVIA 2120 21201 PEROX 2 reagent please see Chapter 8 ADVIA 2120 21201 2 and ADVIA 2120 21201 3 are added to the peroxidase reaction chamber in the second reagent addition The 4 Chloro 1 naphthol in ADVIA 2120 21201 2 serves as a substrate that enables the hydrogen peroxide in ADVIA 2120 21201 PEROX 3 to form a dark precipitate at endogenous sites of peroxidase activity in the granules of white blood cells as described by the following equation cellular peroxidase p H20 4 chloro 1 naphthol dark precipitate within the cells ADVIA 2120 2120i PEROX 3 NOTE For more detailed information on the contents of ADVIA 2120 21201 PEROX 3 reagent please see Chapter 8 ADVIA 2120 21201 2 and ADVIA 2120 21201 3 are added to the peroxidase reaction chamber in the second reagent addition The 4 Chloro 1 naphthol in ADVIA 2120 21201 2 serves as a substrate that enables the hydrogen peroxide in ADVIA 2120 21201 PEROX 3 to form a dark precipitate at endogenous sites of peroxidase
212. e been shown not to be as sensitive and specific in the detection of functional iron deficiency Regulatory Information By providing a direct measure of the hemoglobin content of reticulocytes the CHr Assay gives health care professionals a new sensitive tool for the early detection of functional iron deficiency and provides additional information that can be used in managing the iron requirements for rHuEPO therapy Bibliography Savage RA Skoog DD and Rabinovich A Analytical inaccuracy and imprecision in reticulocyte counting A preliminary report from the College of American Pathologist s reticulocyte project Blood Cells 11 97 112 1985 Brugnara C Colella G Cremins J Langley R Schneider T Rutherford C Goldberg M Effects of subcutaneous recombinant human erythropoietin in normal subjects Development of decreased reticulocyte hemoglobin content and iron deficient erythropoiesis J Lab Clin Med 123 660 667 1994 Fishbane S et al Reticulocyte hemoglobin content in the evaluation of iron status in hemodialysis patients Kidney Intl 52 217 222 1997 Reagents The following ready to use reagents are required to perform the Reticulocyte method and maintain the ADVIA 2120 21201 Hematology System ADVIA 120 autoRETIC ADVIA 120 SHEATH RINSE ADVIA 120 EZ KLEEN ADVIA 120 DEFOAMER ADVIA 120 autoRETIC REF Product Number Contents Amount mL 04296794 01 3622 54 autoRETIC 4 x 820 mL T01 3622 01 autoRETIC 820 mL ADVIA 1
213. e counter associated with the Alarm Criteria is automatically reset MPO Deficiency Stop The number of consecutive occurrences of this condition has met the criterion specified for a stop message The autosampler halts at the same time the stop message occurs The specified stop criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Stop Criteria is reset when the Start Stop button is selected NACK Received A conflict has occurred in host communications Status Line messages Corrective Action Call Siemens Service for assistance No BASO MN PMN Valley Alarm The number of consecutive occurrences of this condition has met the criterion specified for an alarm message The specified alarm criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Alarm Criteria is automatically reset No 5 MN PMN Valley Stop The number of consecutive occurrences of this condition has met the criterion specified for a stop message The autosampler halts at the same time the stop message occurs The specified stop criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Stop Criteria is reset when the Start Stop button is selected No Cell Cluster Fit on PEROX Alarm The number of consecutive occurrences of this condition has met the criterion specified f
214. e eye or skin irritation Use household bleach that is free of heavy metals such as Clorox To prepare a 25 solution of household bleach dilute one part of bleach with three parts of clean distilled water or clean deionized water The prepared solution is stable for one week when stored at room temperature Warnings and Safety Information Safety Information Safety features have been incorporated into the ADVIA 2120 21201 system to protect the operator from injury the analyzer from damage and the test results from inaccuracies Regulatory Compliance Standards or regulations The ADVIA 2120 2120i conforms to the following safety standards or regulations EN61010 1 1993 Safety Requirements for Electrical Equipment for Measurement Control and Laboratory Use Part 1 EN60825 1 Safety of Laser Products Part 1 UL 3101 1 Electrical Equipment for Laboratory Use Part 1 General Requirements CAN CSA C22 2 No Safety requirements for Electrical Equipment for 1010 1 92 Measurement Control and Laboratory Use Part 1 General Requirements CFR 47 Chapt 1 This equipment has been tested and found to comply FCC Subpart B with the limits of a Class A digital device pursuant to Part 15 103 part 15 of the FCC Rules These limits are designed to Exempted Devices C provide reasonable protection against harmful Part 15 105 A interference when equipment is operated in a commercial environment This equipment generates uses
215. e host computer administrator Make sure the address and name are separated by at least one space If there is an error in the Host name or IP address correct it Then on the File menu select Save Close Notepad Status Line messages OPEN Sid Already Exists The host has sent a workorder to the Data Manager that already exists in the database The Data Manager cannot update the current workorder with the new one because the sample status is Incomplete Current Complete Complete or All Complete Parallel Node Error Reset Required Potential software communication error or hardware failure associated with the Parallel Node Board Possible Cause Corrective Action 1 Software Reset the analyzer by selecting Utilities communication Exerciser Indicators Analyzer Reset error or hardware b After about 1 minute if the status line does not failure display Ready to Run and the green ready to aspirate light is still off follow these steps to exit the ADVIA 2120 21201 software turn off the analyzer and then restart i Select Shut Down ADVIA in the Log On Off window ii Select Off at the analyzer touchpad iii Select CTRL ALT DELETE and log back onto the system to restart the software iv Restart the analyzer by selecting On at the analyzer touchpad 2 Faulty power Call Siemens Service for assistance supply fuse cable Parallel Node Board or Can Bus Scrambler Board Patient QC Formula Not Defined This err
216. e in the Customize Menu System Setup Alarm Stop Criteria Reagent Conditions Corrective Action The alarm counter is automatically reset after reagents are replenished and the Reagent Installation window is updated Go to Logs Reagent Log Reagent Installation PEROX Temperature Out Alarm The number of consecutive occurrences of this condition has met the criterion specified for an alarm message The specified alarm criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Alarm Criteria is automatically reset Status Line messages PEROX Temperature Out Stop The number of consecutive occurrences of this condition has met the criterion specified for a stop message The autosampler halts at the same time the stop message occurs The specified stop criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Stop Criteria is reset when the Start Stop button is selected Platelet Clumps Alarm The number of consecutive occurrences of this condition has met the criterion specified for an alarm message The specified alarm criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Alarm Criteria is automatically reset Platelet Clumps Stop The number of consecutive occurrences of this condition has met the criterion specified for a stop message The aut
217. e label that indicates the rack number and sample position Do not twist tube within rack b Load rack onto input queue with labels facing front of analyzer 2 Ifthe Standby indicator is lit press Standby 3 At the touchpad select Start Stop Sampler The Start and Rack in Sampler indicators are lit 4 Evaluate control results or validate patient results when available To run samples from the manual closed tube sampler 1 Ifthe Standby indicator is lit select Standby 2 Run samples in the following order e Whole blood primer primer label e Controls control label e Patient samples sample ID label 3 Scan the tube label or enter the sample information in the Manual Sample ID tab aspirating a sample using either the manual open tube sampler or the manual closed tube sampler Waiting displays on the status line while the system searches for a matching workorder IMPORTANT Make sure the correct sample ID appears the status line before Make sure the correct sample selectivity appears on the status line If you run control with a mismatched selectivity Example running a CBC Diff control with a Retic selectivity the results will not appear in the Review Edit tab and in some cases the system computer may require a restart 4 Aspirate the sample a Insert and push down tube containing the well mixed sample into the manual closed tube sampler Hold tube parallel to the sampler well wall b Sample is auto
218. e photodiode converts the optical scatter and absorption signals from each white blood cell into two signal currents for each of the two channels scatter and absorption Preamplifiers convert these optical signals into signal voltages Laser Optical Assembly Illuminator Assembly Flowcell Location C Detection Assembly The laser optical assembly consists of the illuminator flowcell and detector assemblies A laser diode housed in the illuminator assembly is used as the light source The image of a slit illuminated by light from the laser diode is focused into the flowcell The sample sheath stream in the flowcell contains iso volumetrically sphered red blood cells RBC The RBCs and reticulocytes that pass through the slit image in the flowcell scatter light at low and high angles the stained reticulocytes also absorb a percentage of the light The scattered light is detected by the two scatter photodiodes and generates the following signals Ahigh angle scatter signal corresponding to light scattered at angles between 5 and 15 Welcome to the ADVIA 2120 2120i Hematology System e A low angle scatter signal corresponding to light scattered at angles between 2 and 3 F H J A Laser Diode Driver D Hi NA Lens G Asymetrical Dark Stop Board Beam Splitter H Low Angle Scatter B Laser Diode Detector F Absorption Detector C Sample Stream Beam Divider J High Angle Scatter Detector
219. e red power connector 5 Turn the analyzer on and align the lamp to maximize its output See page 5 4 for instructions Replacing the perox flowcell Time Installation 15 minutes Checkout 15 minutes Analyzer mode Standby BIOHAZARD All products or objects that come in contact with human or animal body fluids should be handled before and after cleaning as if capable of transmitting infectious diseases Wear facial protection gloves and protective clothing The operator should follow the recommendations to prevent the transmission of infectious agents in health care settings as recommended for potentially infectious specimens in Protection of Laboratory Workers from Infectious Disease Transmitted by Blood Body Fluids and Tissue 2nd edition Approved Guideline 1997 Document M29 A National Committee for Clinical Laboratory Standards NCCLS This document contains complete information on user protection and it can be used as reference material for instructions on laboratory safety IMPORTANT An inspection scope must be available for this procedure Do not remove the flowcells unless you are trained in how to align and focus them To remove the flowcell 1 Make sure that the analyzer is in the Standby mode Troubleshooting the Analyzer 5 39 2 Open the optics cover The perox flowcell is on the left Perox flowcell 1 RBC flowcell 2 oh A a i H i i 3 Disconnect the sh
220. e whole blood sample is mixed with ADVIA 120 BASO reagent that contains acid and surfactant The red cells are hemolyzed and the white blood cells are then analyzed using 2 angle laser light scatter signals Bibliography Cremins J and Orlik J Leukocyte differential method US Patent 5 518 928 1996 RBC Platelet Count Both red blood cells and platelets are analyzed by a single optical cytometer after appropriate dilution of the blood sample with ADVIA 120 RBC PLT reagent The red blood cells are isovolumetrically sphered and lightly fixed with glutaraldehyde to preserve the spherical shape Red cells and platelets are counted from the signals from a common detector with 2 different gain settings On the ADVIA 2120 2120i Hematology system the platelet signals are amplified considerably more than the RBC signals Coincidence correction is made to each of the counts so that accurate counts are made over a wide range of each cell type Bibliography Kim YR and Ornstein L Isovolumetric sphering of erythrocytes for more accurate and precise cell volume measurement by flow cytometry Cytometry 3 b 419 427 1983 Zelmanovic et al US Patent pending RBC Platelet Size The method of sizing red cells and platelets uses the simultaneous measurement of laser light scattered at 2 different angular intervals which eliminates the adverse effect of variation in cellular hemoglobin concentration on the determination of cell volume Bibliog
221. ean the syringe with 10 household bleach solution 12 Turn the analyzer on and run samples in the manual and autosampler modes Check to make sure that there are no leaks and that fluid passes through the filters properly Make sure that the lines do not interfere with the autosampler aspirator motion Cleaning the Perox Chamber BIOHAZARD All products or objects that come in contact with human or animal body fluids should be handled before and after cleaning as if capable of transmitting infectious diseases Wear facial protection gloves and protective clothing The operator should follow the recommendations to prevent the transmission of infectious agents in health care settings as recommended for potentially infectious specimens in Protection of Laboratory Workers from Infectious Disease Transmitted by Blood Body Fluids and Tissue 2nd edition Approved Guideline 1997 Document M29 A National Committee for Clinical Laboratory Standards NCCLS This document contains complete information on user protection and it can be used as reference material for instructions on laboratory safety Troubleshooting the Analyzer 5 7 5 8 Materials required Time 2 minutes Analyzer mode Ready to Run Cotton swab Dental mirror EZ KLEEN Flashlight Pipette 2 mm ID disposable 1 PEROX CHAMBER CAP 2 PEROX CHAMBER To clean the perox chamber 1 2 Remove the chamber 1 Dip clean cotton
222. ed e New smearing tape e Paper towels Time 2 minutes ADVIA Autoslide Slide Maker Stainer 10 43 10 44 Analyzer mode Standby To replace the smearing tape 1 At the Operations menu select Autoslide Control The Autoslide Control window opens Under the Special Functions section select Smearing Tape Under Smearing Tape Options select Replace Tape Open the Autoslide lower front cover Using the black magnetic knob open the tape holder plate Remove the upper and lower bobbins from their holders Each time the smearing tape is replaced wipe the wedge using a soft cloth to remove any dust Place the new smearing tape bobbin on the upper holder and the take up bobbin on the lower holder Be careful not to twist or crimp the tape Thread it through the spindles as shown in the diagram on the inside of the front cover ADVIA Autoslide Slide Maker Stainer 9 Close the tape holder plate 10 At the Autoslide Control window select Start to tighten the tape Replacing the Printer Ribbon Materials required New print cartridge Time 2 minutes Analyzer mode Standby To replace the print ribbon AN CAUTION Make sure all slides are processed and transferred to the output queue before turning off the Autoslide Turning off the autoslide while slides are processing can cause unreliable results and possibly damage Autoslide components Turn off the Autoslide 2 Open the lower
223. ed in the Review Edit tab and the Run Screen These flags one to three plus signs alert the operator to possible cellular conditions that may require additional laboratory attention such as preparing a slide for microscopic examination System messages are displayed on the status lines on the PC monitor Along with the messages color coded icons indicate the severity level of the message Welcome to the ADVIA 2120 2120i Hematology System Specifications Autosampler Sample Capacity Tube Sizes Tube Types Barcode reader 150 samples 15 racks of 10 tubes 10 13 mm diameter 50 100 mm height Some of the allowable tube types Standard VACUTAINER HEMOGARD Center puncture Monovette Venoject II Reads up to 14 digits Automatic label code discrimination Codabar Interleave 2 of 5 with and without check digit Code 39 Code 128 EAN and JAN 8 and 13 Data Management e Database storage capacity of 10 000 records including graphics e Review and edit capability User defined windows User defined reports User defined ranges based on age and sex for Normal Rerun Panic and Delta Check criteria e Bi directional and host query communication protocols e Quality control 3D bar graph Levey Jennings plot SDI graph Table format Welcome to the ADVIA 2120 2120i Hematology System 1 21 1 22 e Remote QC e programs e Patient moving average e User assistance Context sensitive help Op
224. edle cover in place screw the needle 1 clockwise o into the needle base Be careful not to E cross thread the needle AN CAUTION Do not use any other tools to secure the needle Overtightening can affect needle performance c Remove the red cover from the needle and save it for use during the next needle installation Reconnect all the tubes except the sample line on the autosampler to the centering collar Analyser Autoslide centering MCTS centering collar collar gt 8 y C Te E E 6 The dual Autosampler has two centering collars one for analyzer sampling and one for optional Autoslide sampling Both Centering collars use the same sampling needles Carefully replace the collar over the needle On the autosampler centering collar be sure to turn the spring loaded knob back to its original position On the autosampler reposition the autosampler aspirator assembly Make sure that it drops firmly in place over the guide pins then reconnect the sample line to the base of the centering collar Maintaining the Analyzer AN CAUTION After repositioning the aspirator assembly finger tighten the thumb screws being careful that they are not cross threaded Overtightening of the screws can warp the baseplate which will cause misalignment of the sampler Mis threading the thumb screws can cause needle damage 10 Place the tubes going to the autosampler centering collar into the
225. edure Reticulocyte Cell Count Historically reticulocytes have been assayed by manual methods via the microscope in conjunction with nucleic acid stains such as new methylene blue and brilliant cresyl blue This method uses a nucleic acid dye oxazine 750 to stain cellular RNA Two microliters 2 uL of an EDTA anticoagulated whole blood sample are mixed online with the ADVIA 120 autoRETIC reagent The ADVIA 120 autoRETIC reagent isovolumetrically spheres the erythroid cells and stains cellular RNA Low angle laser light scatter high angle laser light scatter and absorption characteristics of all cells are counted and measured The absorption data are used to classify each cell as a reticulocyte or mature red blood cell based on its RNA content Reticulocyte Size The method of sizing reticulocytes uses the simultaneous measurement of laser light scattered at two 2 different angular intervals which eliminates the adverse effect of variation in cellular hemoglobin concentration on the determination of the MCVr parameter CHr The CHr is the mean of cellular hemoglobin content CH histogram for the reticulocyte population CHr has been shown to be an early indicator of functional iron deficiency Functional iron deficiency has been shown to occur when erythropoietin rHuEPO is employed in the treatment of anemia associated with end stage renal failure and other diseases Traditional methods for the detection of iron deficiency hav
226. el Replacing the Hydraulic Valves There are six hydraulic valves three are located below the perox flowcell and three are below the RBC baso retic flowcell Materials required e Flat head screwdriver small e Hydraulic valve PN 067 1024 01 Time Replacement 10 minutes Checkout 15 minutes Analyzer mode Off Troubleshooting the Analyzer A ELECTRICAL WARNING To avoid exposure to shock hazards and or damage to the instrument while performing this procedure power off the analyzer before proceeding BIOHAZARD All products or objects that come in contact with human or animal body fluids should be handled before and after cleaning as if capable of transmitting infectious diseases Wear facial protection gloves and protective clothing The operator should follow the recommendations to prevent the transmission of infectious agents in health care settings as recommended for potentially infectious specimens in Protection of Laboratory Workers from Infectious Disease Transmitted by Blood Body Fluids and Tissue 2nd edition Approved Guideline 1997 Document M29 A National Committee for Clinical Laboratory Standards NCCLS This document contains complete information on user protection and it can be used as reference material for instructions on laboratory safety 1 Remove the tubing from the ports on the valve fitting then carefully unscrew the fittings 2 Remove the two mounting screws Pull the valve forward un
227. ell Count in RBC HC histogram 100 x Methods Methods MICRO MICRO RATIO Parameter Key Dilution Factor The dilution factor for the RBC channel is 83 33333E 6 RBC Red blood cell count MCV Mean Corpuscular Volume RDW Red Cell Volume Distribution Width CHCM Corpuscular Hemoglobin Concentration Mean CH Cellular Hemoglobin Content HDW Hemoglobin Concentration Distribution Width HCT Hematocrit Number of red cells RBC R Count x RBC Valid Cells RBC R Count RBC P Count RBC R Count Number of cells in the RBC area 1 of the RBC Scatter Cytogram RBC Valid Cells The number of valid electronic pulse signals detected from flowcell events 8 51 8 52 RBC P Count Number of cells in the platelet area 1 of the RBC Scatter Cytogram Cell Hemoglobin Distribution Width RBC Dead Time Percent of analysis time when the channel is busy and cannot detect flowcell events RBC Coin Level RBC Coincidence Level RBC Coin Count RBC Coincidence Count RBC R Count Raw red blood cell count from the RBC method RBC P Count Raw platelet count from the RBC method MACRO Percent of macrocytic red blood cells MICRO Percent of microcytic red blood cells MICRO Number of microcytic red blood cells HYPER Percent of hyperchromic red blood cells HYPO Percent of hypochromic red blood cells Ratio This parameter is reported to
228. ells nRBCs appear in the NRBC cluster 1 which is located between the Noise and Lymphocyte areas The system uses data from the perox channel and the baso channel to derive the Nucleated Red Blood Cell NRBC count CONRBC and NRBC If nRBCs are present the system corrects the WBC results to account for them Location of Atypical Lymphocytes on PEROX Cytogram Atypical lymphocytes are large cells with no peroxidase activity that can appear in the LUC area 1 Similarly blasts and other large abnormal cells with no peroxidase activity also appear in the LUC area 1 Methods Location of Immature Granulocytes on PEROX Cytogram Immature Granulocytes are large cells with high peroxidase activity that can appear in the neutrophil area 1 and the saturation area 2 Location of Bands on PEROX Cytogram Bands appear within the the Neutrophil population 1 due to their similar size and degree of peroxidase staining Platelet Clumps form a separate cluster 1 that originates in the Noise area on the PEROX cytogram Methods 8 31 8 32 Location of Unlysed RBCs on PEROX Cytogram Unlysed RBCs with no peroxidase activity appear along the left side of the PEROX cytogram Calculating Parameters Reported Parameters Parameter Explanation WBCP RawWBC x PeroxCalFactor 1 FracDT NEUT 100 x Neutrophil Count PHA Cells NEUT NEUT 100 x WBC LY MPH 100 x Lymph
229. em The cells are then detected and enumerated based on light scatter and absorbance measurements using the ADVIA 22120 21201 22120 2120ii laser optics A scatter versus scatter and scatter versus absorbance cytogram is displayed with the thresholds and results automatically calculated for each sample Reportable parameters are WBC and RBC counts along with absolute and percentage counts for neutrophils lymphocytes monocytes polymorphonuclear PMN and mononuclear MN cells A research use only eosinophil count is also given CSF Scatter Scatter Cytogram The CSF Scatter Scatter Cytogram is a 100 x 100 channel two dimensional pulse height distribution of the scatter high and scatter low data for WBC RBC and noise where the X axis is high angle scatter and the Y axis is low angle scatter A fixed mask is used to set thresholds for Neutrophil Lymphocyte Monocyte and RBC regions Eosinophils fall within the Neutrophil region in this cytogram The number of eosinophils is determined from the Scatter Absorption cytogram and is subtracted from the number of cells in the Neutrophil region prior to calculating WBC and Neutrophil parameters At this time eosinophil data is for research purposes only and is non reportable CSF Scatter Absorption Cytogram The CSF Scatter Absorption Cytogram is a 100 x 100 channel two dimensional pulse height distribution of the scatter high and absorption data for WBC RBC and noise where the X axis is absorpt
230. emperature 2 Check the reaction chamber temperature controller including the electrical connection Platelet Noise PLT NO NT Definition The PLT NO flag indicates the presence of sample interferences such as microcytes or RBC fragments that could be counted as large platelets The PLT NO flag is triggered under either of the following conditions e LPLT and ANISO flags are triggered any severity level e LPLT and MICRO flags are triggered any severity level Normal Sample PLT NO Flag RBC Scatter RBC Scatter Platelet Vol Platelet Vol Flags Flags Results Flagged PLT PCT MPV and PDW Corrective Action The following conditions may not be the only ones that could cause this flag e Pronounced microcytosis e Increased RBC fragments RBCF Platelet Origin Noise PLTORN OT Definition The Platelet Origin Noise flag indicates the occurrence of system induced noise that might affect RBC and PLT results The PLTORN flag is triggered when the number of events in the Platelet Origin Noise area of the PLT cytogram exceeds 2 of the total number of events Normal Sample PLTORN Flag PLT Cytogram PLT Cytogram j 1 Platelet Origin Noise area 2 RBC Ghosts area Results Flagged RBC MCV HCT MCH MCHC CH CHCM CHDW RDW HDW PLT PCT MPV and PDW Corrective Action Multiple occurrences of this flag especially for consecutive samples can indicate a system problem e Check
231. ened reagents are stable until the expiration date printed on the product label when stored at room temperature between 15 C and 30 C Once opened reagents are stable for 45 days Do not refrigerate Refer to the online ADVIA 2120 21201 Operator s Guide for information on specimen collection Material required but not provided Microscope slides 26 x 76 x 1 mm Size 76 x 26 x Imm Description ground edges rounded corners super frost Use slides provided by Siemens approved vendors only Limitations Modified Wright reagents produce high quality stained blood films However there may be personal preferences in shades and intensities of staining not satisfied by the system Results When used with the ADVIA Autoslide Slide Maker Stainer the Modified Wright reagents will produce a consistent stain quality to facilitate accurate and reliable interpretation Technical Assistance For customer support please contact your local technical support provider or distributor Bibliography 1 Romanowsky DL On the Question of Parasitology and Therapy of Malaria St Petersburg Medical Weekly 16 297 302 1891 ADVIA Autoslide Slide Maker Stainer 10 31 10 32 2 White WL Erickson MM Stevens SC Practical Automation for the Clinical Laboratory St Louis MO CV Mosby Co pp 476 487 1972 3 Moss ED Automated Slide Staining in Haematology Can J Med Tech 30 5 169 1968 Wright Giemsa Method Intended Use
232. ent Log Reagent Installation PEROX 1 Reagent Low Alarm The number of consecutive occurrences of this condition has met the criterion specified for an alarm message indicating that the reagent level is low The specified alarm criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria Reagent Conditions Corrective Action The alarm counter is automatically reset after reagents are replenished and the Reagent Installation window is updated Go to Logs Reagent Log Reagent Installation Status Line messages 7 69 7 70 PEROX 2 Reagent Empty Stop The number of consecutive occurrences of this condition has met the criterion specified for a stop message The reagent is empty and the autosampler has halted The specified alarm criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria Reagent Conditions Corrective Action The stop counter is automatically reset after reagents are replenished and the Reagent Installation window is updated Go to Logs Reagent Log Reagent Installation Select Start Stop to continue the run PEROX 2 Reagent Expired Present date is beyond the PEROX 2 reagent expiration date as determined by encoded reagent container barcode label or as calculated from installation date and open container stability Corrective Action Replenish expired reagents and update the Reagent Installation window Go to Logs Reagent Log Reagent Installation PE
233. entage of red blood cells with higher than normal cell volumes is equal to or greater than 2 5 The parameter indicates the percent of red blood cells that have a volume equal to or greater than 120 fL and is derived from the RBC volume histogram Default trigger values for the three severity levels are t 2 5 to 6 4 MACRO 6 5 to 10 5 gt 10 5 The value is intended for flagging and laboratory purposes only Results Flagged none Possible Causes The following list of sample related causes may not contain all conditions that could cause this flag Multiple occurrences of this flag especially for consecutive samples can indicate a system problem However isolated instances of this flag are usually sample related 6 13 6 14 Sample Related System Related e Macrocytic anemia 1 Check the RBC reagents Alcoholism 2 Check the RBC hydraulics e Hemolytic anemia 3 Check the RBC gains 4 Myelodysplastic anemia Check the laser flowcell alignment e Neonatal samples Microcytosis MICRO Definition The Microcytosis flag is triggered if the percentage of red blood cells with lower than normal cell volumes MICRO is equal to or greater than 2 5 The MICRO parameter indicates the percent of red blood cells that have a volume equal to or lower than 60 fL and is derived from the RBC volume histogram Default trigger values for
234. ents are replenished and the Reagent Installation window is updated Go to Logs Reagent Log Reagent Installation Hyperchromia Alarm The number of consecutive occurrences of this condition has met the criterion specified for an alarm message The specified alarm criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Alarm Criteria is automatically reset Hyperchromia Stop The number of consecutive occurrences of this condition has met the criterion specified for a stop message The autosampler halts at the same time the stop message occurs The specified stop criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Stop Criteria is reset when the Start Stop button is selected Image Affected to Wrong Group There is a conflict between two settings in the Customer Parameters 7 52 Status Line messages The parameters in Customer Parameters 21 ASSOCIATE CBC DIFF IMAGE WITH A TEST GROUP and ASSOCIATE RETIC IMAGE WITH A TEST GROUP can be set only to values attached to a test group The test groups are defined in Customer Parameters 17 Corrective Action 1 Open Customer Parameters in Tools Modify mode 2 Define the test groups in Customer Parameters 17 3 Set the values 21 to correspond to the test groups you have defined or 1 Open Customer Parameters in Tools Modify mode 2 Set the value
235. ents with inherited or acquired deficiency of the myeloperoxidase enzyme Such deficiency has been observed in approximately 0 5 of laboratory specimens Regulatory Information 9 51 9 52 5 In certain abnormal specimens specifically lymphoid disorders and leukemias erroneously elevated basophil counts may be observed Expected Values The range of expected values can vary depending on age sex diet and location It is recommended that each laboratory establish its own range of expected values The following range of expected values is based upon the duplicate assay of 60 whole blood specimens obtained from an adult population of assumed healthy individuals Parameter Low Value High Value NEUT 40 77 LY MPH 16 44 MONO 4 9 EOS 1 7 BASO 0 1 PLUC 1 4 NOTE Because of numerical rounding the Diff results should total 100 0 2 except when BASO is gt 5 and the Baso Count Suspect B SUSP BC flag is triggered In cases where the total is greater than 100 0 2 the amount in excess of 100 is due to BASO Performance Characteristics Imprecision A total of 18 runs were performed using multiple samples The following estimates of imprecision were obtained by taking 25 aspirations from each whole blood sample Each of the sample selectivity modes was tested by sampling from opened tubes and with the manual and automated closed tube samplers Parameter Mean Standard CV Deviation 55 0 0 9 1 6
236. erator s guide Procedure wizards Problem solving diagnostics Remote diagnostics Parameters CBC Results WBC RBC HGB HCT MCV MCH MCHC CHCM RDW HDW CH CHDW PLT Differential Results absolute and NEUT LYMPH MONO EOS BASO LUC Large Unstained Cells Platelet Results PLT MPV PDW PCT Reticulocyte Results RETIC RETIC MCVr CHCMr CHr Morphology Results user definable WEC Left Shift Atypical Lymph Blasts Immature Granulocytes Myeloperoxidase Deficiency RBC ANISO MICRO MACRO HC VAR HYPO HYPER RBC Fragments RBC Ghosts NRBC Platelet Clumps Large Platelets Blasts Limitations Smear review by a competent morphologist is necessary to ensure detection of significant blood cell abnormalities Each laboratory is responsible for developing it s own protocols for determining which samples require smear review and or manual differential blood cell counts based on automated cell count results and clinical information The system provides morphology and quantitative flags that utilize sophisticated algorithms to assist in the identification of significantly abnormal samples Laboratory protocols may use these flags internally in their smear review and manual differential specifications Whenever morphology or quantitative flags are triggered it is the responsibility of the laboratory to validate the results Welcome to the ADVIA 2120 2120i Hematology System Performance Specification
237. erent from the published average imprecision Correlation Data Correlation data were determined using human whole blood samples by comparing the performance of the ADVIA 120 Hematology System with the performance of a reference method or a comparative system where applicable Regression statistics were computed using a protocol similar to that recommended in the CLSI Document M29 A3 Protection of Laboratory Workers from Occupationally Acquired Infections Approved Guideline Third Edition 2005 Regression data in each method indicate the linear least squares fit between the ADVIA 120 Hematology System y and the comparative system method x unless noted otherwise Carryover This topic lists the sample carryover for the ADVIA 120 Hematology System Analytical Range This topic describes the concentration range across which acceptable results can be obtained from the method Some specimens may exceed the range of the method and produce error flags or messages Regulatory Information 9 17 CLSI Document M29 A3 and Siemens Method Topics Cross Reference 9 18 CLSI Approved Guideline M29 A3 5 1 2 Title 5 1 2 1 Title 5 1 2 2 Type of Specimen 5 1 2 3 Method or instrumentation in subtitle 5 1 3 Principle 5 1 3 1 Type of reaction s involved 5 1 3 2 Clinical reasons for performing the test 5 1 4 Specimen 5 1 4 1 State the conditions for patient preparation 5 1 4 2 Type of specimen 5 1 4 3 Special handling co
238. ering values for all events including those from the noise area Noise Lymph histogram provides the light scattering values for the noise lymphocyte and large unstained cells LUC areas Information from the monocyte neutrophil and eosinophil areas is excluded PEROX Cytogram is formed from the paired light scatter and absorption data Cluster analysis identifies the individual populations Perox Rate Histogram The PEROX Rate histogram shows the uniformity of the cell counting rate The rate histogram data consists of 50 points one taken every 200 milliseconds Each point represents the number of valid cells counted during the last 200 milliseconds Perox X Histogram PEROX X histogram displays the absorption values for all cells Information from the noise area is excluded Increasing channel numbers on the PEROX X histogram correspond to greater intensity of peroxidase staining Methods 8 27 8 28 Perox Y Histogram PEROX Y histogram displays the light scattering values for all events including those from the noise area Increasing channel numbers 1 Noise on the PEROX Y histogram 2 Lymphocytes correspond to greater cell 3 Large Unstained Cells LUC size volume Noise Lymph Histogram The Noise Lymph histogram provides the light scattering values for the noise lymphocyte and large unstained cells LUC areas The Noise Lymph histogram is used to derive the following parameters e The
239. es Autosampler Autosampler is Already Running The autosampler received a command to start or eject racks while it was running Autosampler Bad Mixer Aspiration Cal Mixer aspiration calibration failed in diagnostic mode Exerciser tab AN CAUTION Call Siemens Service for assistance Only Siemens Service personnel are authorized to take these corrective actions Possible Cause Corrective Action 1 Autosampler Calibrate mixer aspirate position again calibration error 2 Autosampler Replace autosampler CPU board CPU board failed to store calibration data in flash memory Autosampler Bad Mixer Shuttle Cal Mixer shuttle index calibration failed in diagnostic mode Exerciser tab AN CAUTION Call Siemens Service for assistance Only Siemens Service personnel are authorized to take these corrective actions Possible Cause Corrective Action 1 Autosampler Calibrate mixer shuttle index position again calibration error 2 Autosampler Replace autosampler CPU board CPU board failed to store calibration data in flash memory Status Line messages 7 15 Autosampler Calibration Required To start the analyzer initial calibration values for the Car Index position Mixer Shuttle position and the Mixer Aspirate position must be stored in flash memory AN CAUTION Call Siemens Service for assistance Only Siemens Service personnel are authorized to take these corrective actions Possible Cause Corrective
240. es 2 Check the perox reaction chamber temperature e Hemolytic anemia 3 Check peroxidase hydraulics and sample e Myelodysplastic delivery syndromes 4 Check perox gains Flags Platelet Clumps PLT CLM NW Definition Presence of clumped platelets is suspected The Platelet Clumps flag is triggered if the Clumps Count in the PLT Clumps region of the Perox cytogram is greater than 150 The PLT count is flagged to alert the user that the platelet count may not be accurate due to the presence of platelet clumps The PLT Clump area of the Perox cytogram originates in the Noise area and extends upward to the right of the lymphocyte population The number of events obtained from this area is called the Clumps Count The Clumps Count is excluded from the WBCP and differential results There is no severity level associated with this flag Perox Cytogram Perox Cytogram Normal Sample PLT CLM flag 1 PLT Clumps area Results Flagged WBCP PLT PCT MPV and PDW Possible Causes The following list of sample related causes may not contain all conditions that could cause this flag Multiple occurrences of this flag especially for consecutive samples can indicate a system problem However isolated instances of this flag are usually sample related Flags 6 17 6 18 Sample Related e Traumatic venipuncture Anticoagulants e Autoimmune platelet disorders e Lipemia RBC Fragments RBCF Definition The pr
241. es 4 COVER VIEW E Mek Lees fon E 4 STATEMENT 2 1 2 12 11000000000000000000000000000000500000000 N 4 SAMPLE COLLECTION AND PREPARATION 4 CALIBRATOR AND CONTROL PRODUCTS scssssssecececsessseececececsessaececececsessaesesececeenenaeea 5 ANCILLARY JREA GENTS rre REC eR 8 COOPERATION ROVER NE CREER MANENTE 8 CALCULATION OF RESULTS 9 INTERPRETATION OF RESULTS 205 6553 5 IS ees eet crit Ede 9 WASTE DISPOSAL REQUIREMENTS ccsscccsccecsessssececececeesessececececeesensesecececeenennsaeeeeeeeenes 10 WASTE ANALYSIS eere eibi E I 10 SYSTEM METHOD INFORMATION cccccesssssececececsenseaececececseseaaececececeessaaeceeeeeceessaseeeecs 13 SYSTEM METHOD INFORMATION INTENDED 5 00000 0 14 SYSTEM METHOD INFORMATION PRINCIPLES OF THE 14 SYSTEM METHOD INFORMATION REAGENTS eene SYSTEM METHOD INFORMATION STORAGE AND STABILITY SYSTEM METHOD INFORMATION SAMPLE 20 1 0000000000000 SYSTEM METHOD INFORMATION MATERIALS REQUIRED BUT NOT PROVIDED 15 SYSTEM METHOD INFORMATION PROCEDURE eene enne nennen nennen 15 SYSTEM METHOD INFORMATIO
242. es flag is triggered if NEUT EOS PMN gt 5 0 If present Immature Granulocytes appear in the neutrophil and eosinophil areas on the Perox cytogram and in the mononuclear MN area on the Baso cytogram On the BASO cytogram the eosinophils and neutrophils reside within the Polymorphonuclear PMN area Subtracting the PMN from the sum of the NEUT and EOS provides an estimate of the Immature Granulocytes Default trigger values for the three severity levels are NEUT EOS 5 0 to 7 4 NEUT EOS 7 5 to 10 0 NEUT EOS PMN gt 10 0 Perox Cytogram Baso Cytogram 1 Lymph 2 LUC 3 Mono 4 Neut 5 Eos 6 MN 7 PMN MN 6 Lymphs 1 LUCs 2 Monos 3 PMN 7 Neut 4 Eos 5 Flags Flags Results Flagged none Possible Causes The following list of sample related causes may not contain all conditions that could cause this flag Multiple occurrences of this flag especially for consecutive samples can indicate a system problem However isolated instances of this flag are usually sample related Sample Related System Related e Myelocytic leukemia 1 Troubleshoot the baso channel e Chronic infections 2 Troubleshoot the perox channel e Neonatal samples 3 Check the baso and perox gains Large Platelets LPLT Definition The Large Platelets flag is triggered if the percentage of large platelets LPLT is greater than 1046 of the platelet count
243. esence of RBC fragments is suspected This flag is triggered if the number of events in the RBC Fragment area of the PLT Scatter cytogram is greater than 100 000 cells uL The event count in this area includes red blood cell fragments with volumes less than 30fL and refractive indexes greater than 1 400 RBC fragments are excluded from the PLT count and the RBC count There are no severity levels associated with this flag Normal Abnormal PLT Scatter Cytogram PLT Scatter Cytogram 4 1 RBC Ghost area 2 Platelet area 3 RBC Fragment area NOTE Whenever the ratio of RBC fragments to platelets exceeds 0 25 the system uses the log normal fit calculation to determine the platelet count and the log normal fit curve appears on the Platelet Volume histogram The RBC Fragment value is intended for flagging and laboratory purposes only Results Flagged none Flags Possible Causes The following list of sample related causes may not contain all conditions that could cause this flag Multiple occurrences of this flag especially for consecutive samples can indicate a system problem However isolated instances of this flag are usually sample related Sample Related Hemolytic anemia e Prosthetic heart valves e Severe burns e Sickle Cell Anemia RBC Ghosts RBCG Definition The presence of RBC ghosts is suspected This flag occurs if the number of events in the RBC Ghost area of the PLT Scatter cytogram is greater
244. estart the analyzer 3 If the problem persists call Siemens Service for assistance Autosampler Mixer Lost Steps Reset Autosampler The autosampler mixer is not in the expected position A reset is required Possible Cause 1 Car movement problem Corrective Action a Atthe analyzer touchpad select Off b Wait about 1 minute and select On to restart the analyzer c Ifthe problem persists call Siemens Service for assistance Status Line messages 2 Persistent car movement problem causing binding and excessive drag on the racks AN CAUTION Call Siemens Service for assistance Only Siemens Service personnel are authorized to take these corrective actions a Perform the mixer alignment procedure as necessary b Check pushpin and centering collar operation when the mixer is in the aspirate position Check for signs of excessive friction in the mixer bearings Autosampler Mixer Motion Denied Reset Autosampler The autosampler attempted to perform an inappropriate mixer motion An autosampler reset is required Corrective Action 1 Select Off at the analyzer touchpad 2 Wait about 1 minute and select On to restart the analyzer 3 Ifthe problem persists call Siemens Service for assistance Autosampler Mixer Motion Failed Reset Autosampler The autosampler failed to perform a routine mixer motion during normal rack processing A reset is required Status Line messages Possible Cause
245. ethanol 36 37 S45 Highly Flammable Highly flammable Keep away from sources of ignition No smoking Contains methanol Wright Giemsa Buffer e Phosphate buffer e Surfactant e Preservative Methanol e Methyl Alcohol 99 8 Toxic Toxic danger of very serious irreversible effects through inhalation in contact with skin and if swallowed Keep container tightly closed Avoid contact with skin Wear suitable protective clothing and R39 23 24 25 gloves In case of accident or if you feel unwell seek medical advice 57 24 immediately show the label where possible Contains methanol 36 37 S45 Highly Flammable Highly flammable Keep away from sources of ignition No smoking Contains methanol R11 S16 ADVIA Autoslide Slide Maker Stainer 10 35 10 36 Reagent Storage and Stability Store Stain Buffer and Methanol tightly closed between 15 C and 30 C During the system run cover each reagent with Parafilm or equivalent to avoid excessive evaporation When unopened reagents are stable until the expiration date printed on the product label when stored at room temperature between 15 C and 30 C Once opened reagents are stable for 45 days Do not refrigerate Refer to the online ADVIA 2120 2120i Operator s Guide for information on specimen collection Material required but not provided Microscope slides 26 x 76 x 1 mm Size 76 x 26 x Imm Description ground edges rounded corners super f
246. ets Measurement RBC Method A pair of low angle light scatter 2 to 3 and high angle light scatter 5 to 15 signals are used to analyze red blood cells Using the Mie theory of light scattering for homogeneous spheres the low angle light scatter measurement is converted into cell volume and the high angle light scatter measurement is converted into hemoglobin concentration The following histograms and cytograms are used for red blood cell analysis RBC Rate histogram shows the arrival rate of cells in the RBC Platelet channel RBC Volume histogram shows the distribution of red cells by cell volume RBC HC histogram shows the distribution of red cells by hemoglobin concentration independent of cell volume RBC CH histogram shows the distribution of red cells by hemoglobin content RBC Scatter cytogram is formed by plotting the high angle light scatter 5 to 15 along the x axis and the low angle light scatter 2 to 3 on the y axis RBC V HC cytogram is a presentation of the RBC volume and Hgb concentration data intended for evaluating red cell morphology RBC Matrix provides the cell counts and percentages for the corresponding nine regions on the RBC V HC cytogram Measurement Platelet Method A low angle light scatter 2 to 3 signal is amplified 30 times and a high angle light scatter 5 to 15 signal is amplified 12 times These high gain signals are used to analyze platelets Methods Methods
247. etween 18 C and 30 C e All unopened reagents are stable until the expiration date printed on the product label DO NOT FREEZE e Opened containers of ADVIA 120 CSF reagent are stable for one month e The product should be clear colorless and free of visible particulate matter Do not use if product is cloudy discolored or contains visible matter Controls When stored between 2 C and 8 C e When stored as directed unopened controls are stable through the expiration date printed on the product label DO NOT FREEZE e Opened containers are stable for 10 days Gain Adjustment The gain adjustment procedure is used to adjust the amplification signals in a channel to properly position the cell signatures within a cytogram There are no CSF specific gain adjustments required Calibration Calibration is not required for the CSF Assay Accurate cell counts are derived through correct RBC gain adjustment Sample Handling Sample Dilution Samples may be diluted up to 1 10 1 part sample and 9 parts phosphate buffered saline PBS or normal saline before preparation with CSF reagent Sample Regulatory Information 9 35 9 36 Sample Stability CSF patient samples are not stable and should be assayed as soon as possible after collection Siemens recommends that CSF patient samples be prepared with CSF reagent within one hour after collection Once prepared with CSF reagent the prepared sample is stable between 4 minutes and
248. f Laboratory Workers from Infectious Disease Transmitted by Blood Body Fluids and Tissue 2nd edition Approved Guideline 1997 Document M29 A National Committee for Clinical Laboratory Standards NCCLS This document contains complete information on user protection and it can be used as reference material for instructions on laboratory safety To replace the syringe plunger 1 Turn the thumb wheel 1 counterclockwise until the plunger is lowered about 0 5 inch 1 27 cm 2 Disconnect the tubing from the top fittings then disconnect the input 2 and output 3 fittings from the syringe head 3 Remove the nut and washer that secure the syringe at the top Slide the syringe barrel down toward the bottom of the carriage then remove AN CAUTION The 50 uL syringe plunger has a small plastic bushing inside the syringe When replacing this plunger never pull the plunger through the small bushing This action will cause damage to the plunger tip Use a small hex wrench or a large paper clip to pop the bushing out of the syringe completely then remove the plunger from the syringe with the bushing still on the plunger stem Maintaining the Analyzer 4 17 4 18 6 4 Use a hexagonal wrench to loosen the set screws 4 on the metal bushing 5 on the plunger stem Remove and keep the bushing Discard the plunger 7 5 Inspect the syringe If the inside surface is dirty use a wash bottle with 25 solution of household
249. f consecutive occurrences of this condition has met the criterion specified for an alarm message The specified alarm criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Alarm Criteria is automatically reset No PEROX Noise Lymph Valley Stop The number of consecutive occurrences of this condition has met the criterion specified for a stop message The autosampler halts at the same time the stop message occurs The specified stop criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Stop Criteria is reset when the Start Stop button is selected No Test There is a message problem with the test request sent from the host Corrective Action Verify that the host is sending the test request If the problem recurs call Siemens Service for assistance Status Line messages No Type The type of test request sent by the host is not defined in the Test Dictionary Corrective Action Verify the accuracy of the host test table Define the test in Test Dictionary Select Customize menu System Setup Tools Modify Test Dictionary No Workorder Alarm No workorder received for current patient sample The number of consecutive occurrences of this condition has met the criterion specified for an alarm message Possible Cause Corrective Action 1 work order has not been created for the current patient sample
250. f the ADVIA 2120 2120i system This prevents any further system function The system displays the following message communication error with autoslide The Autoslide icon remains green NOTE The Autoslide system can remain on 4 Unscrew the Austoslide sample blood line 1 Figure 1 Sample Blood Line ADVIA Autoslide Slide Maker Stainer 5 Pry open the protective conduit tubing where the vacuum 1 and pressure 2 lines reside Figure 2 Vacuum and Pressure Lines ADVIA Autoslide Slide Maker Stainer 10 17 6 Push the metal lever and pull the vacuum line 1 to disconnect Figure 3 Vacuum Line 7 Push the metal lever and pull the pressure line 1 to disconnect Figure 4 Pressure Line ADVIA Autoslide Slide Maker Stainer 10 18 8 Loosen the 2 screws where the slots are on the Autoslide cart bracket so you can move the support structure Figure 5 Autoslide cart bracket with loosened screws 9 Move the support structure forward up to 0 3 m 1 ft ensuring that the electrical cables are not stretched to far Blood sample line Pressure line Ground strap A amp oN oL Vacuum line Figure 6 Moved Support Structure NOTE The ground strap and interface cable remain connected to the Autoslide Disconnecting the sample blood line pressure line and vacuum lines allows you to move the Autoslide approximately 0 3 m 1 ft 10 To reconnect the Autoslide move the Autoslide module
251. fied alarm criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria Reagent Conditions Corrective Action The stop counter is automatically reset after reagents are replenished and the Reagent Installation window is updated Go to Logs Reagent Log Reagent Installation Select Start Stop to continue the run autoRETIC Reagent Expired Present date is beyond the autoRETIC reagent expiration date as determined by encoded reagent container barcode label or as calculated from installation date and open container stability Corrective Action Replenish expired reagents and update the Reagent Installation window Go to Logs Reagent Log Reagent Installation autoRETIC Reagent Low Alarm The number of consecutive occurrences of this condition has met the criterion specified for an alarm message indicating that the reagent level is low The specified alarm criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria Reagent Conditions Corrective Action The alarm counter is automatically reset after reagents are replenished and the Reagent Installation window is updated Go to Logs Reagent Log Reagent Installation Autosampler Access Door Open The autosampler access door is open 24V interlock switch is open Corrective Action 1 Close the autosampler access door The autosampler resets 2 Ifthe problem persists call Siemens Service for assistance Status Line messag
252. for assistance Only Siemens autosampler Service personnel are authorized to take these corrective CPU board is actions faulty a Check output queue sensor and sensor wiring b Make sure pressing output queue sensor flag triggers sensor Make sure output queue ribbon is plugged in securely Status Line messages 7 31 d Replace autosampler CPU board Autosampler Output Queue Jammed The output queue is jammed Possible Cause Corrective Action 1 Leading edge Remove racks from output queue and or output shuttle of the output queue pan blade spears rack 2 Output queue Check for foreign objects in output queue queue motion covers or pinch guard impeded wes b Make sure output queue moves freely 3 Feed motor Call Siemens Service for assistance failure Autosampler Output Queue Motion Denied To prevent the collision of autosampler components the system did not execute the command to move the autosampler output queue Autosampler Output Queue Motion Failed The autosampler output queue failed to move properly Possible Cause Corrective Action 1 Leading edge a Remove racks from output queue and shuttle of the output queue blade has speared a rack b Select Start at the analyzer touchpad The autosampler resumes operation 2 Queue cannot Check the output queue queue covers and pinch guard move for foreign objects Make sure the queue moves freely properly 3 Feed motor Call Siemens Serv
253. form your daily tasks directly at the monitor without using the keyboard On the touchscreen monitor you can do the following e Use your finger with or without gloves to select all window controls including function buttons and operations in the online Help e Move a window by holding your finger on the title bar of the window drag the window to the new location NOTE The touchscreen may not responds correctly if your finger or gloves are wet You can clean the touchscreen monitor using a lint free paper towel dampened with 5 bleach solution Dry the screen and your hands throroughly Manual Barcode reader 2 _ Yo The manual barcode reader is used to enter information from labels on sample tubes reagent containers controls and calibrators As each label is correctly read the LED on the wand will blink Welcome to the ADVIA 2120 2120i Hematology System 1 13 Waste removal system All analyzer waste is stored in an 11 liter waste container This container can be a stand alone container which has to be emptied manually or part of the automatic waste removal system When the fluid level in either of the containers reaches the maximum level line approximately 8 liters an error message appears on the Status line on the personal computer monitor The analyzer will not aspirate any more samples until the waste container is emptied Welcome to the ADVIA 2120 2120i Hemato
254. ftware turn off the analyzer and then restart Status Line messages Select Shut Down ADVIA at the Log On Off window ii Select at the analyzer touchpad iii Select CTRL ALT DELETE and log back onto the system to restart the software iv Restart the analyzer by selecting On at the analyzer touchpad 2 Pressure out of Verify pressure readings and adjust if necessary range 3 Faulty power Call Siemens Service for assistance supply fuse cable Pressure S witc h Node Board or Can Bus Scrambler Board Printer Busy Printing Aborted The printer was busy when a printout was requested Corrective Action Restart the printout when the printer is free Printer Not Defined The printer is not defined in the Port Configuration window Corrective Action Correct or enter the printer definition in the Port Configuration window Select Customize menu System Setup Tools Modify Port Configuration Printer Not Ready Impression Aborted A printer problem has occurred during background printing of a results report No message box is displayed The printout will resume as soon as the printer is available Corrective Action Verify printer connections and operation Status Line messages 7 77 7 78 Printer Problem Alarm A printer problem has occurred The number of consecutive occurrences of this condition has met the criterion specified for an alarm message The specified alarm criterion is user defina
255. gent Log Reagent Installation Sid Already Exists Result Message Rejected You have created a workorder with an Sid having the format 909XXXX This format is used by the analyzer to send results of misread samples The results are refused Corrective Action Create a workorder with a proper Sid format Standby The analyzer is in a low power state that reduces component wear during periods of inactivity The green ready to aspirate light is off Typically the analyzer enters standby automatically Use the touchpad Standby button to exit or enter the standby state manually Corrective Action Status Line messages 7 91 7 92 If the analyzer is locked in the standby state verify that the pressure and vacuum readings are within range and adjust if necessary Select Standby to exit Status BTRIEVE Alarm Not Defined An alarm sent from the analyzer is unknown to the Data Manager not defined in the Alarm Dictionary Corrective Action See Alarm Dictionary Status BTRIEVE Test Not Found A test defined in the Control Dictionary has been erased from the Test Dictionary Corrective Action Enter test information in the Test Dictionary Syntax Error in AlarmExc par The parameter file AlarmExc par is not correctly defined or there is a blank line in the file No exclusive analytical alarm will be taken into account in the patient QC calculation Corrective Action Call Siemens Service for assistance S
256. greater than the BLAST by 1 5 or more Default trigger values for the three severity levels are LUC 4 5 to 7 4 LUC 7 5 to 10 0 LUC gt 10 0 Flags 6 5 6 6 Perox Cytogram ATYP Baso Cytogram 1 LUC area 2 BLASTS area Results Flagged none Possible Causes The following list of sample related causes may not contain all conditions that could cause this flag Multiple occurrences of this flag especially for consecutive samples can indicate a system problem However isolated instances of this flag are usually sample related Sample Related System Related e Viral infections 1 Check the perox reagents e Lymphoproliferative 2 Check the delivery of SHEATH RINSE disorders 3 Check the perox hydraulics and sample e RBC nonlysis delivery 4 Check the perox reaction chamber temperature 5 Check the perox flowcell alignment 6 Check the perox gains Blasts BLASTS Definition The presence of blasts is suspected Blasts are detected in the Blasts area on the Baso cytogram and in the LUC area of the Perox cytogram The triggering conditions for this flag are e BLASTS 1 5 to 5 0 and LUC gt 4 5 or BLASTS gt 5 0 of the total WBCB or BASO BASO Susp BASO Sat 10 Flags Flags Default trigger values for the three severity levels are BLASTS 1 5 to 5 0 BLASTS gt 5 0 to 10 0 BLASTS gt 10 0 Perox Cytogram Baso Cytogram
257. h WBC counts less than 20 cells uL should be confirmed using an alternate method 2 The ADVIA 120 CSF Assay can accurately analyze samples with up to 1500 RBC uL Samples that are suspected of containing greater than 1500 RBC uL may be diluted up to 1 10 with PBS 3 ADVIA 2120 21201 Hematology System provides no morphology flagging to indicate the presence of abnormal cells in the CSF Assay Only High Low flagging and the Laser Power Low system flag are enabled for the CSF Assay 4 Improper sample handling or failure to review CSF cytograms for possible interferences analysis artifacts may produce erroneous results Examples of improper sample handling include but are not limited to Inadequate mixing of CSF patient sample or prepared sample before Regulatory Information 9 39 9 40 aspiration on the ADVIA 120 Incomplete sample aspiration on the ADVIA 120 Incomplete incubation time e Samples with total protein content 500 1000 mg dL should be analyzed within 1 hour after preparation with CSF reagent Increased protein concentrations may cause precipitation of cells and proteins in the prepared sample e The ADVIA 120 CSF RBC count provides no information to distinguish between elevated CSF RBC counts due to cerebral hemorrhage or traumatic spinal tap Interfering Substances e Samples containing oily or fatty contaminants may interfere with the ADVIA 120 cell counts Avoid oily contaminants such as si
258. han 27 pg Cellular Hemoglobin Mean is the mean of the RETIC CH histogram for the reticulocyte population Cellular Hemoglobin Mean is the mean of the RETIC CH histogram for the mature RBC population Cellular Hemoglobin Mean is the mean of the RETIC CH histogram for the gated cells CHr CHm Cellular Hemoglobin Distribution Width is the standard deviation SD of the RETIC CH histogram for the reticulocyte population Cellular Hemoglobin Distribution Width is the standard deviation SD of the RETIC CH histogram for the mature RBC population 8 63 8 64 CHDWg Cellular Hemoglobin Distribution Width is the standard deviation SD of the RETIC CH histogram for the gated cells CHDW Delta CHDWr CHDWm RETIC Scatter Abs Cytogram The RETIC Scatter ABS cytogram is the graphical representation of the absorption and light scatter measurements the high gain absorption cell maturation is plotted along the x axis and the high angle low gain light scatter cell size is plotted along the y axis RTC Platelet threshold 2 RTC Coincidence threshold 3 RTC threshold 4 Low Medium RTC threshold 5 Medium High RTC threshold A Mature RBCs B Low absorption retics C Medium absorption retics D High absorption retics E Platelets F Coincidence events The two thresholds on the y axis 1 2 are set as follows 1 The analyzer scans for the scatter mode between channels 10 and 99 on the y axis 2 The mean channel a
259. hat hepatitis B or C viruses HIV or other infectious agents are absent these products should be handled according to established good laboratory practices Siemens supplies control and calibrator products for use with the ADVIA 2120 21201 Hematology System Refer to the current Price List and the product package insert for additional information ADVIA 120 TESTpoint 3 in 1 Hematology Control Abnormal 1 Product Symbol Contents Amount Number mL T03 4417 54 cowrmo asw Hematology Control 4 4 0 mL Abnormal 1 03 4417 01 Hematology Control 4 0 mL Abnormal 1 ADVIA 120 TEST Point 3 in 1Hematology Control Abnormal 2 Product Symbol Contents Amount Number mL 03 4418 54 Hematology Control 4x 4 0 mL Abnormal 2 Regulatory Information 9 5 REF REF 01964346 REF 08822644 REF 00848547 REF 05147873 REF 09170071 9 6 Product Symbol Number 03 4418 01 ADVIA 120 TEST Point 3 in 1 Hematology Control Normal Contents Amount mL Hematology Control 4 0 mL Abnormal 2 Contents Amount mL Hematology Control 4x 4 0 mL Normal Hematology Control 4 0 mL Normal ADVIA 120 TESTpoint Hematology Control High Product Symbol Number T03 4416 54 T03 4416 01 Product Symbol Number 03 3688 54 contRoL mon 03 3688 01 Contents Amount mL Hematology Control 4x4 0mL High Hematology Control 4 0 mL High ADVIA 120 TESTpoint Hematology Control Low
260. he item for which you want help d Ll Second Status Line Left Side Current system state for example Ready to Run Right Side System messages and icons that indicate the message severity Information accompanies a message that provides information only No operator action is necessary Failure alerts you to a serious problem that requires your immediate intervention before work can continue Most errors of this type are associated with conditions that automatically stop the system I Warning alerts you to a condition that requires some action Menus Each of the buttons on the top of the screen displays a menu of system functions The menu appears when you move the pointer over the button When you click an item on a menu the corresponding window opens the button appears to be pressed and the other functions on the menu appear as tabs arranged beneath the status lines Welcome to the ADVIA 2120 2120i Hematology System 1 17 1 18 NOTE System Setup on the Customize menu contains a submenu To display the submenu move the pointer over System Setup on the menu Click an item on the submenu to open the corresponding window Tabs The tabs correspond to the items on the active menu You can switch to any one of these functions by clicking the corresponding tab When you select an option from a different menu the tabs change to those available from that menu Left side buttons Some tabs contain
261. he autosampler This error appears sometimes when a rack is waiting in the input shuttle area Move the rack back to the first position in the tray and start the autosampler again Cannot Find Videos Cannot find the videos opideos op hlp Help file Check to see that the file exists on your disk If it doesn t you need to reinstall it If you get this message when trying to view the videos and you have recently installed a Zip drive the letter assigned to your CD ROM drive may have changed Reinstall the Operator s Guide The installation process will reset the correct path to the videos Checking Drain Filters for Clogs See Replacing the Drain Filters on page 5 27 Compressor Does Not Start In cases when the analyzer is turned off and restarted too 1 quickly the compressor may not start up causing the ii 8 system initialization to fail This is due to residual vacuum in the waste container The operator must il manually vent the container SS To manually vent either container manual or autowaste A disconnect the waste container vacuum line 1 wait for the vacuum to dissipate and then reconnect the line Troubleshooting the Analyzer 5 49 5 50 Data Manager and LIS At the host computer how can tell controls apart In the SID that is sent to the host the first two digits after the C identify the control as follows Control First Second Type Digit Digit CBC DIFF 1 1 4 or 7 Low 2 5
262. he number of cells nuclei in each population The following BASO cytograms were obtained from a representative patient specimen 1 Noise 5 Baso Suspect 2 Blast cell nuclei 6 Saturation 3 Mononuclear WBCs 7 Polymorphonuclear WBCs Monocyte and Lymphocyte nuclei Neutrophil and Eosinophil nuclei 4 Basophils Noise Area This area contains platelets RBC stroma and other cellular debris that are not included in the total white blood cell count WBCB Blast Cluster When present blasts appear in the blast cluster Mononuclear Cluster In normal samples the MN population contains lymphocyte and monocyte nuclei Basophil Cluster With their cytoplasm intact basophils are much larger than the white cell nuclei and appear in the Basophil cluster Baso Suspect Cluster Contains unlysed cells other than basophils Counts from this area are not included in the basophil count Saturation Area Typically this area contains air bubbles that are not included in the basophil or WBCB count Methods Methods Polymorphonuclear Cluster In normal samples the PMN population contains eosinophil and neutrophil nuclei BASO Cytogram Histogram Analysis If the cluster analysis does not agree with a normal archetype due to a low cell count or if there is only one identifiable cell population the following cell populations are identified using histogram analysis Basophils MN mononuclear cells PMN polymorphonuclear cells Blasts No
263. he product was IEC 61010 1 safety tested by TUV for conformity to global markets including Canada US and EU This symbol indicates that the colorimeter conforms with DIN standard 58 960 developed by the Working Committee on Photometers of the Standards Committee on Medicine NAMed in the DIN Deutsches Institute f r Normung e V This symbol indicates that the product is a Class 1 laser product with no laser exposure during normal operation This symbol indicates that the product is a Class 2 laser product with potential exposure to a laser beam This is the On symbol Warnings and Safety Information 923644 D e BIP ei Warnings and Safety Information e This is the Off symbol This is the Start symbol This is the Standby symbol This symbol indicates the switch position for normal system operation of the waste container This symbol indicates the switch position for emptying the waste container This symbol indicates the need to empty the waste container This symbol indicates the open and closed positions for a spigot This symbol indicates liquid waste This symbol indicates pressure In this example the symbol indicates 20 PSI This symbol indicates vacuum In this example the symbol indicates a vacuum of 20 Hg This symbol indicates the manual open tube sampler This symbol indicates the manual closed tube sampler This symbol indicates
264. her before loading e Make sure to load the slides in the correct orientation The painted area must be on the top of the slides and on the left hand side of the stack e Insert a stack of slides as shown above The stack of slides must reach the stack level detectors The slide dispenser can hold up to 160 slides Emptying the Stain Waste Container The stain waste is collected in a container located behind the system Empty the container periodically or whenever the system indicates that the container is full Stain waste must be collected using the tube and container specified by local regulation Stain waste contains methanol Methanol is a solvent that may destroy an inappropriate connection and cause leaks that are dangerous for the user and damaging to the instrument Dispose of waste according to local regulatory requirements WARNING Make sure that the Autoslide module is not processing slides while you disconnect the stain waste container IMPORTANT Local laws and regulations protect the environment and encourage resource conservation by regulating the disposal of hazardous wastes Because some of the wastes generated by the analyzer may be classified as hazardous waste you must be familiar with the applicable hazardous waste handling and disposal laws and regulations in your area Running the Daily Startup Manually Your system can be set to run the startup procedure at a preset time However if the system is not set
265. hook on the side of the IDee reader 11 Close the front cover 12 Run saline and whole blood primers to verify system performance Replacing the Sheath Filters There are two sheath filters located on either side of the analyzer The perox sheath filter is in a green housing on the left side and the RBC baso sheath filter is in a clear housing on the right side of the instrument Time 10 minutes Location of the perox 1 and the RBC baso 2 sheath filters Materials required e Perox sheath filter PN 518 3148 05 e RBC baso sheath filter PN 518 3148 06 e paper towels Analyzer mode Ready to Run To replace the sheath filters 1 Carefully pull the filter toward you just enough to remove it from its mounting and gain access to the tubing Place paper towels under the filter to catch any fluid that leaks out when you remove the filter 2 Disconnect the reagent line 1 attached to the barbed fitting 2 at the input port 3 of the filter Maintaining the Analyzer 4 15 1 2 4 3 5 Disconnect the luer fitting 4 from the connector at the output port 5 Do not disconnect the line leading from the luer fitting Discard the filter according to local environmental laws and regulations Hold the replacement sheath filter by the body and attach the luer fitting to the connector Turn the luer fitting clockwise tighten AN CAUTION The plastic barbed fitting and the luer connector are very fragile
266. hylene glycol 99 2 For in vitro diagnostic use ADVIA 120 PEROX 3 PN T01 3632 01 2 x 585 mL ADVIA 120 PEROX 3 contains Stabilizer Hydrogen peroxide 0 3 For in vitro diagnostic use ADVIA 120 PEROX SHEATH PN T01 3633 01 2 x 2725 mL ADVIA 120 PEROX SHEATH contains Propylene glycol 4 06 mol L Surfactant For in vitro diagnostic use PEROX SHEATH is also available separately REF Product Number Symbol Contents Amount mL 03624240 01 3633 54 SHEATH 4 x 2725 mL 9 48 Regulatory Information Storage and Stability Reagents When stored between 15 C and 30 C e All unopened reagents are stable until the expiration date printed on the product label e Opened containers of the ADVIA 120 BASO ADVIA 120 PEROX 1 ADVIA 120 PEROX 2 ADVIA 120 PEROX 3 and ADVIA 120 PEROX SHEATH reagents are stable for 90 days Calibrators and Controls Protect product from freezing When stored at 2 C to 8 C unopened ADVIA OPTIpoint Prod No T03 3682 01 ADVIA SETpoint Calibrator PN T03 3685 01 and ADVIA TESTpoint Hematology Controls PN T03 3686 01 Low T03 3687 01 Normal and T03 3688 01 High respectively are stable until the last day of the month of the expiration date printed on the product label unless stated otherwise After being opened ADVIA OPTIpoint is stable for 7 days ADVIA TESTpoint Hematology Controls are stable for 10 days and the ADVIA SETpoint Calibrator is stable for 5 days whe
267. ial Replace clot filter Check connections and tighten if necessary Rinse needle Select Utilities menu Hydraulic Functions tab Needle Rinse Replace the needle Follow the steps in Replacing the Sampler Needles Contact your local Siemens technical support provider for assistance QC Sample Deleted Before Validation A control sample that was not validated has been deleted Daily QC may not be consistent Rack or Position Barcode Not Read Alarm The barcode reader cannot determine a valid rack ID or position number for the current tube position The number of consecutive occurrences of this condition has met the criterion specified for an alarm message in the Alarm Stop Criteria window Status Line messages Possible Cause 1 Barcode label improperly placed obscured or absent Faulty barcode reader Corrective Action Check that a barcode label is properly attached and meets specifications Replace if necessary Call Siemens Service for assistance 7 79 7 80 Rack or Position Barcode Not Read Stop The barcode reader cannot determine a valid rack ID or position number for the current tube position The number of consecutive occurrences of this condition has met the criterion specified for a stop message in the Alarm Stop Criteria window and the autosampler has halted Possible Cause Corrective Action 1 Barcode label Check that a barcode label is properly attached and improperly meets specif
268. iate the flag with specific diagnoses System Related Sample Related 1 Check perox reagents e Neonatal samples 2 Check peroxidase hydraulics and sample e Aged blood sample delivery e Malaria parasites 3 Check delivery of SHEATH RINSE 4 Check PEROX SHEATH delivery 5 Check the pressure and vacuum readings 6 Check the perox reaction chamber temperature 7 Check perox flowcell alignment 8 Check perox gains Perox Noise PX NO NX Definition The Perox Noise flag is triggered if 60 or more of the perox signals come from the Noise area of the Perox cytogram This flag is triggered if 60 or more of the PEROX events are counted in the Noise area Flags Normal PX NO Perox Cytogram Perox Cytogram 1 Noise area The PX NO NX flag is not triggered if agreement between the baso and perox results is indicated by both the following conditions e WBCB and WBCP agree within specified limits No WBC CE flag NEUT EOS PMN is between 0 and 7 5The Noise area is located in the lower left corner of the Perox cytogram 1 Results Flagged WBCP NEUT NEUT LYMPH LYMPH MONO EOS EOS LUC and LUC Corrective Action Multiple occurrences of this flag especially for consecutive samples can indicate a system problem However isolated instances of this flag are usually sample related The following list of sample related causes may not contain all conditions that co
269. iation CV of the RETIC Volume histogram channels 15 to 99 for the gated cells RDW Delta RDWr RDWm RETIC HC Histogram The RETIC hemoglobin concentration RETIC HC histogram represents the overlaid distributions of mature RBCs and reticulocytes by cellular hemoglobin concentration only The histogram has a range from 0 g dL to 50 g dL The displayed data includes the CHCMg calibration factor Mature RBC population red Reticulocyte population blue 8 61 8 62 RETIC HC Histogram Parameters HY PERr HYPERm HYPERg 76H Y POr HYPOm HYPOg CHCMr CHCMm CHCMg CHCM Delta HDWr HDWm HDWg HDW Delta Percentage of reticulocyte population with cellular hemoglobin concentration greater than 41 g dL Percentage of mature RBC population with cellular hemoglobin concentration greater than 41 g dL Percentage of gated cell population with cellular hemoglobin concentration greater than 41 g dL Percentage of reticulocyte population with cellular hemoglobin concentration less than 28 g dL Percentage of mature RBC population with cellular hemoglobin concentration less than 28 g dL Percentage of gated cell population with cellular hemoglobin concentration less than 28 g dL Cellular Hemoglobin Concentration Mean is the mean of the RETIC HC histogram for the reticulocyte population Cellular Hemoglobin Concentration Mean is the mean of the RETIC HC histogram for the mature RBC populat
270. ications Replace if necessary placed obscured or absent 2 Faulty barcode Call Siemens Service for assistance reader RBC Fragments Alarm The number of consecutive occurrences of this condition has met the criterion specified for an alarm message The specified alarm criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Alarm Criteria is automatically reset RBC Fragments Stop The number of consecutive occurrences of this condition has met the criterion specified for a stop message The autosampler halts at the same time the stop message occurs The specified stop criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Stop Criteria is reset when the Start Stop button is selected RBC Ghosts Alarm The number of consecutive occurrences of this condition has met the criterion specified for an alarm message The specified alarm criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Alarm Criteria is automatically reset RBC Ghosts Stop The number of consecutive occurrences of this condition has met the criterion specified for a stop message The autosampler halts at the same time the stop message occurs The specified stop criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with th
271. ice for assistance has failed Autosampler Output Shuttle Blocked A rack in the output shuttle position is preventing the autosampler from completing a movement 7 32 Status Line messages Corrective Action a Remove the rack from the shuttle position at the front of the output queue b Select Start at the analyzer touchpad to restart autosampler operation Autosampler Output Shuttle Failed There is no rack in the output shuttle position at the end of shuttle motion The probable cause is the removal of the rack by the user before the shuttle stops Autosampler Output Shuttle Not Empty The autosampler has attempted to move a rack to the output shuttle but the shuttle is not empty Corrective Action Remove rack from the output shuttle Autosampler Pushpin Extend Denied To prevent the collision of autosampler components the system did not execute the command to extend the autosampler pushpin Autosampler Pushpin Motion Denied Reset Autosampler The autosampler attempted an inappropriate pushpin motion An autosampler reset is required Corrective Action 1 Select Off at the analyzer touchpad 2 Wait about 1 minute and select On to restart the analyzer 3 If the problem persists call Siemens Service for assistance Autosampler Pushpin Retract Denied To prevent the collision of autosampler components the system did not execute the command to retract the autosampler pushpin Autosampler Pushpin F
272. ide Maker Stainer 10 21 10 22 Cell Type Cell Component Cytoplasm Granules Lymphocytes Nuclei Cytoplasm Monocytes Nuclei Cytoplasm Granules Eosinophils Nuclei Cytoplasm Granules Basophils Nuclei Cytoplasm Granules Platelets Cytoplasm Granules Red Blood Cells Biconcave disks Howell Jolly bodies Dohle bodies Promyelocyte and Granules Auer Rods Causes of RBC Artifacts e Post stain rinsing too short e Reagents expired Color Pink Light purple violet Deep purple Blue Light purple Blue gray Fine pink to violet Pale purplish blue Bluish pink Orange Purplish blue Faint pink Deep purple Light blue Blue to violet blue Pink Dark purple Blue gray Dark blue to Purplish red e May Griinwald Stain open for extended period e Dirty stainer e Room temperature too high e Humidity too high e Slide not dry before examination Reagents and Supplies For in vitro diagnostic use ADVIA Autoslide Slide Maker Stainer Reagents are ready to use and require no preparation REF Contents Symbols 00283949 May Griinwald 00327415 Japan Stain 1 STN 00283167 Giemsa Stain 2 Osm 00327733 Japan May Gr nwald Giemsa Buffer BUF 00286794 Methanol 0 00326788 CH30H ADVIA Autoslide Rinse RNS Stain 1 May Gr nwald Stain e Methanol 99 65 e Methylene blue Eosin 0 35 inhalation in contact with skin and if swallowed Keep container tightly c
273. ided by Siemens approved vendors only Sample Requirement 75 uL whole blood 10 52 ADVIA Autoslide Slide Maker Stainer Legal Information LIMITED INSTRUMENT WARRANTY AND SERVICE DELIVERY POLICY 2 WARRANTY PERIOD 0 ccccececececececececececececececececececececececececececececececececececececececececececececececs 2 ADDITIONAL SERVICE PERIOD eese eene rennen nnn nennen 2 SERVICE DURING NORMAL 5 3 EXTENT OFA SERVICE CALL 2 e nete eet ee pet ite ere 3 SERVICE OUTSIDE NORMAL 5 3 REPLACEMENT 8 2 2 2 2 222 4 44 44 4 3 DESIGN CHANGES AND RETROFITTING OF 6 442 42 3 KEY OPERATOR DESIGNATION s0ssssesssesssesssesssescsesesssesesesssesesssssesesesesesesssessseesseeseees 4 OSHA REQUIREMENTS US 4 WARRANTY AND SERVICE EXCLUSIONS 2 0 2 20 1 24 0 4 0 4 4244 44 4 44 40 4444 80804444 4 CONTACT 4 4 4 41 52 1 1 4 2 6 001 0 0 010 1 0010 4000 4 4 4 tones eaa 5 SIEMENS AUTHORIZED 1 1 5 ADDRESSES 5058 Sees oe Ede ea ee eas 6 Legal Information A 1 This section provides the following information e address of the
274. igin area of the RETIC Scatter Absorption cytogram The Origin Noise area of the Retic Scatter Abs cytogram is located in absorption channels 1 through 3 Typically an excessive number of events detected in this area is due to unsphered cells or improperly set gains Normal Retic Scatter Abs Cytogram 1 Noise Origin area Results Flagged RETIC CHg CHr CHCMg CHCMr CHDWr CHDWg MCVg MCVr RDWg RDWr Corrective Action Multiple occurrences of this flag especially for consecutive samples can indicate a system problem However isolated instances of this flag are usually sample related The following list of sample related causes may not contain all conditions that could cause this flag There is no intention to associate the flag with specific diagnoses Flags Flags System Related Sample Related 1 Check delivery of the sheath reagent e High platelet count 2 Check delivery of SHEATH RINSE e RBC fragments 3 Check the RBC Baso Retic hydraulics e Aged blood including the reaction chamber e Sickle cell anemia 4 Check the retic hydraulics 5 Check retic gains Retic RBC Count Low RTC L CL Definition The Retic RBC Count Low flag is triggered if the number of cells analyzed is less than 10 000 Results Flagged RETIC CHg CHr CHCMg CHCMr CHDWr CHDWg MCVg MCVr RDWg RDWr Corrective Action Multiple occurrences of this flag especially for consecuti
275. impure methanol can leave a film on the windows use only uncontaminated spectrophotometric grade methanol Gently wipe one glass surface Discard the used piece of lens tissue To prevent formation of a methanol film completely dry the glass using a clean piece of lens tissue Examine the clean surface If the window is not clean enough repeat steps 1 through 3 Repeat steps 1 through 4 for the other optical window Cleaning the Flowcells off the Analyzer Step 6 Replacing the Flowcell 1 Hold the flowcell by its red threaded fitting and place it gently into the optics assembly Perox optical assembly Tighten the release knob to lock the flowcell into position RBC baso retic optical assembly Place the flowcell onto the guide pins Make sure that the flowcell is on both guide pins The flowcell will be at a 4 angle Tighten the flowcell release screw Reconnect the hydraulic lines to the CFM Reconnect the flowcell tube assembly fitting to the appropriate hydraulic valve V24 and V23 Hand tighten the connection enough to prevent leaks IMPORTANT To avoid incorrect patient data make sure that each hydraulic line is attached to the correct CFM nipple Troubleshooting the Analyzer Shuttle line from UFC assembly 3 Sample line from syringe 2 Sheath line from hydraulic valve 1 V15 perox or V19 RBC Cleaning the Flowcells off the Analyzer Step 7 Checking Analyzer Performance IMPORTANT An i
276. in contact with human or animal body fluids should be handled before and after cleaning as if capable of transmitting infectious diseases Wear facial protection gloves and protective clothing The operator should follow the recommendations to prevent the transmission of infectious agents in health care settings as recommended for potentially infectious specimens in Protection of Laboratory Workers from Infectious Disease Transmitted by Blood Body Fluids and Tissue 2d edition Approved Guideline 1997 Document M29 A National Committee for Clinical Laboratory Standards NCCLS This document contains complete information on user protection and it can be used as reference material for instructions on laboratory safety To replace the sampler needles 1 Turn off the analyzer Maintaining the Analyzer 4 13 4 14 Remove the centering collar from the Autosampler or the Manual closed tube sampler See page 4 5 for instructions Turn the needle cover counterclockwise 7 to loosen the needle Discard the needle along with its cover as biohazardous material Before installing the replacement needle clean the needle base using a cotton swab soaked in water then wipe with another cotton swab soaked in water NOTE If there is extensive buildup use a solution of 25 household bleach and water to remove residual dried blood Install the replacement needle a Remove the clear plastic end of the needle cover 1 b With the red ne
277. ines again using the Reagent Inventory window Loading Slide Racks Loading Slides Load at least two racks into the rack loader The rack loader can hold up to 9 racks at a time Load the racks as shown below with the slide grooves facing upwards You can load racks at any time When the autoslide startup cycle runs the slide dispenser must contain slides and there must be racks in the rack loader AN WARNING Do not try to empty the slide dispenser Finger injuries and sensor damage can occur if you attempt to remove slides from the slide dispenser Microscope slides storage and handling When storing and handling microscope slides follow these precautions Microscope slides and cover glasses should be rotated when stored e To prevent moisture contamination store the slides off the floor e To minimize temperature and humidity changes keep slides as far away as possible from doors and heating or air conditioning ducts Remember slides do not have to be old to be affected by moisture Slides should be allowed to come to Lab temperature before they are opened 10 12 ADVIA Autoslide Slide Maker Stainer e Use slides provided by Siemens approved vendors only Size 76 x 26 x Imm Description ground edges rounded corners super frost e Avoid touching slide surfaces with your fingers e Control painted areas of the slides are all facing up e Make sure slides are not stuck toget
278. ing to normal system operation Running the Daily Shutdown Manually Your system can be set to run the shutdown procedure at a preset time However if the system is not set to do so or if you are shutting down at a different time perform the following steps 1 At the Operations menu select Autoslide Control 2 Inthe Autoslide Control tab select Shutdown and then select Start IMPORTANT Once the Daily Shutdown has occurred you must perform a Daily Startup before resuming Autoslide operation Disconnecting an Autoslide 90 Configuration The following procedure explains how disconnect the ADVIA Autoslide system when it is in a 90 configuration for lab automation or a stand alone system ADVIA Autoslide Slide Maker Stainer 10 15 10 16 BIOHAZARD All products or objects that come in contact with human or animal body fluids should be handled before and after cleaning as if capable of transmitting infectious diseases Wear facial protection gloves and protective clothing Do not move the support structure that the ADVIA Autoslide resides on more than 0 3 m 1 ft Make sure that the interface cable and ground strap has enough slack when you move the support structure 1 Make sure all system activity is complete before you disconnect the 90 configuration NOTE Make sure that no slides are present in the Autoslide Stainer 2 Place the ADVIA 2120 21201 system in Standby 3 Select Off on the control panel to shut of
279. inge with bleach solution In the Valves window of the Exerciser tab open V12 and then push the syringe to fill Baso chamber 7 with bleach solution then open V13 to drain Close V12 and V13 Repeat with deionized water Refill the syringe with bleach solution At the Valves window of the Exerciser tab open V64 and then push the syringe to fill Retic chamber 7 with bleach solution then open V65 to drain Close V64 and V65 Repeat with deionized water Disconnect the shuttle line 10 from the side of the UFC 11 and then place the end of the sample tubing into a beaker to catch fluid as you backflush the flowcell Refill the syringe with bleach solution Troubleshooting the Analyzer 15 16 17 18 19 20 21 22 23 Gently push plunger on the cleaning syringe to flush bleach solution through the RBC flowcell 2 Repeat with deionized water Reattach the shuttle line 10 to the side of the UFC 11 Refill the syringe with bleach solution At the Valves window of the Exerciser tab open V20 and 21 and then push the syringe to push bleach solution through the shuttle pathway to the VSC chamber Repeat with deionized water and then close V20 and V21 Remove syringe 4 from the white fitting Reattach the line to the fitting on V23 3 Select the Analyzer Status tab to exit the Exerciser Open the Hydraulic Functions tab and then perform one System Wash cycle Run controls to verify system performanc
280. ion Cellular Hemoglobin Concentration Mean is the mean of the RETIC HC histogram for the gated cells CHCMr CHCMm Hemoglobin Distribution Width is the standard deviation SD of the RETIC HC histogram for the reticulocyte population Hemoglobin Distribution Width is the standard deviation SD of the RETIC HC histogram for the mature RBC population Hemoglobin Distribution Width is the standard deviation SD of the RETIC HC histogram for the gated cells HDWr HDWm Methods Methods RETIC CH Histogram The RETIC cellular hemoglobin RETIC CH histogram represents the overlaid distributions of mature RBCs and reticulocytes by the actual weight or mass of hemoglobin present in each cell The histogram has a range from 0 pg to 100 pg Mature RBC population red Reticulocyte population blue RETIC CH Histogram Parameters HIGH CHr HIGH CHm HIGH CHg LOW CHr LOW CHm LOW CHg CHr CHm CHg CH Delta CHDWr CHDWm Percentage of reticulocyte population with cellular hemoglobin greater than 31 pg Percentage of mature RBC population with cellular hemoglobin greater than 31 pg Percentage of gated cell population with cellular hemoglobin greater than 31 pg Percentage of reticulocyte population with cellular hemoglobin less than 27 pg Percentage of mature RBC population with cellular hemoglobin less than 27 pg Percentage of gated cell population with cellular hemoglobin less t
281. ion and the Y axis is high angle scatter A fixed mask is used to set the threshold for eosinophil analysis Because of their higher absorption eosinophils fall to the right of the neutrophil population in this cytogram and are thus able to be separated from the neutrophil population The number of eosinophils is subtracted from the number of cells falling in the neutrophil region of the Scatter Scatter cytogram before calculating WBC and Neutrophil parameters Methods Methods Calculating Parameters Reported Parameters The following parameters are available for patient reporting Parameter CSF WBC CSF PMN CSF PMN CSF MN CSF MN CSF Neut CSF Neut CSF Lymph CSF Lymph CSF Mono CSF Mono CSF RBC Explanation CSF WBC uL CSF PHA WBC CSF PHA Total x CSF PHA Cells 1 Fractional Dead Time x Perox Nominal Factor CSF PMN 100 x CSF PMN CSF WBC CSF PMN uL CSF PHA PMN CSF PHA Total x CSF PHA Cells 1 Fractional Dead Time x Perox Nominal Factor CSF MN 100 x CSF MN CSF WBC CSF MN uL CSF PHA MN CSF PHA Total x CSF PHA Cells 1 Fractional Dead Time x Perox Nominal Factor 5 Neut 100 x CSF Neut CSF WBC CSF Neut uL CSF PHA Neut CSF PHA Total x CSF PHA Cells 1 Fractional Dead Time x Perox Nominal Factor Lymph 100 x CSF Lymph CSF WBC CSF Lymph uL CSF PHA Lymph CSF PHA Total x CSF PHA Cells 1 Fractional Dead
282. ion has met the criterion specified for a stop message The autosampler halts at the same time the stop message occurs The specified stop criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Stop Criteria is reset when the Start Stop button is selected BTRIEVE TabDic dat File The Type Table Dictionary contains the code of a profile that has been deleted Corrective Action Check and correct the Type Table Dictionary Select Customize menu System Setup Tools Modify Type Table Dictionary Car Motion Failed Reset Autosampler The autosampler failed to move as expected Possible Cause Corrective Action Status Line messages Autosampler software error At the analyzer touchpad select Off Wait about 1 minute and select On to restart the analyzer If problem persists call Siemens Service for assistance Check Waste Container Vacushield The vacuum pump filter vacushield on the waste container may be saturated with liquid Possible Cause 1 Vacuum pump filter vacushield is clogged 2 Vacuum leak 3 Crimped waste line IMPORTANT Corrective Action Replace the vacuum pump filter Check for crimped or disconnected hydraulic or pneumatic lines Straighten or reconnect lines as necessary Check the waste container to make sure that the spigot is closed and the cap is on securely Check for a crimped waste line on the waste container
283. ions Manual Sample ID The sample ID for manually aspirated samples will increment by one for each succeeding aspiration Status Line messages 7 59 7 60 Matching Not Possible Mismatch of Sample Types The test request sent by the host and the unmatched sample are not the same type The test request is refused and the sample remains unmatched Corrective Action Verify the accuracy of the host test table Verify type in Test Dictionary Select Customize menu System Setup Tools Modify Test Dictionary Microcytosis Alarm The number of consecutive occurrences of this condition has met the criterion specified for an alarm message The specified alarm criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Alarm Criteria is automatically reset Microcytosis Stop The number of consecutive occurrences of this condition has met the criterion specified for a stop message The autosampler halts at the same time the stop message occurs The specified stop criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Stop Criteria is reset when the Start Stop button is selected MPO Deficiency Alarm The number of consecutive occurrences of this condition has met the criterion specified for an alarm message The specified alarm criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria Th
284. ir lines supplying needle cylinder At the analyzer touchpad select d Wait about minute and select On to restart the analyzer e If the problem persists call Siemens Service for assistance 2 Needle sensor Call Siemens Service for assistance failed Autosampler Needle Motion Denied Reset Autosampler The autosampler attempted an inappropriate needle motion An autosampler reset is required Corrective Action 7 30 Status Line messages 1 Select Off at the analyzer touchpad 2 Wait about 1 minute and select On to restart the analyzer 3 If the problem persists call Siemens Service for assistance Autosampler Needle Retract Denied To prevent the collision of autosampler components the system did not execute the command to retract the autosampler needle Autosampler No Tube Present Pushpin cannot find tube in current rack position Rack spring clip is broken and holds tube incorrectly Corrective Action Remove rack and check spring clip Autosampler Operating Mode Not in Effect The autosampler is not in operating mode Corrective Action 1 Open the Autosampler window of the Exerciser tab 2 Exit the Exerciser tab by opening another tab Autosampler Output Queue Full Possible Cause Corrective Action 1 Output queue Remove racks from output queue and or output shuttle and or output shuttle are full 2 Output queue AN CAUTION sensor ribbon cable or Call Siemens Service
285. is out of range if necessary Setpoint 20 Hg 1 2 Vacuum leak Check for crimped or disconnected hydraulic or pneumatic lines Straighten or reconnect lines as necessary b Check the waste container to make sure that the spigot is closed and the cap is on securely 3 Vacuum pump Replace the vacuum pump filter filter vacushield is clogged 4 Crimped waste Check for a crimped waste line on the waste container line Straighten or reconnect lines as necessary Status Line messages UFC Vacuum Out of Range Stop System vacuum is out of range The system has stopped because the vacuum has reached a critical level that may affect the integrity of sample results and damage the system The difference between the compressor vacuum and UFC vacuum is greater than 5 Hg Possible Cause Corrective Action 1 Vacuum Check the system vacuum gauge and adjust the regulator Setting is out if necessary of range Setpoint 20 Hg 1 2 Vacuum leak Check for crimped or disconnected hydraulic or pneumatic lines Straighten or reconnect lines as necessary b Check the waste container to make sure that the spigot is closed and the cap is on securely 3 Vacuum pump Replace the vacuum pump filter filter vacushield is clogged 4 Crimped waste Check for a crimped waste line on the waste container line Straighten or reconnect lines as necessary IMPORTANT If problems persist Call Siemens Service for assistance Further corrective action
286. ise and Baso Saturation area Baso Noise threshold Blast threshold MN PMN valley threshold Basophil threshold Baso Saturation threshold Noise nuclei Blast cell v N gt Mononuclear WBCs Monocyte and Lymphocyte nuclei Basophils not used Saturation N Oo Polymorphonuclear WBCs Neutrophil and Eosinophil nuclei o BASO X histogram 8 7 Baso Noise Threshold Basophil Threshold Baso Saturation Threshold Lr m 8 8 This threshold shown as a red line is set at channel 4 on the y axis Events below this threshold are counted as noise while cells above the threshold are included in the white cell count WBCB This threshold shown as a red line separates the Basophils from the nuclei of the other cell types The threshold is set at channel 21 on the y axis All cells above this threshold are counted as Basophils This threshold shown as a red line is set at channel 45 on the x axis and channel 21 on the y axis Events within this area microbubbles clumped cells and unlysed cells are monitored for flagging purposes Methods Methods Blast Threshold This threshold shown as a red line is set at channel 8 on the x axis and between channels 4 and 21 on the y axis All cells below to the left of this threshold are counted as Blasts which are monitored for flagging purposes only The Blast count should not be reporte
287. ishing certain cell types When using the ADVIA 120 CSF assay the CSF sample is mixed with ADVIA 120 CSF reagent which spheres and fixes the cells After a minimum 4 minute to 4 hour incubation period the prepared sample is then aspirated directly into the ADVIA 120 system The cells are then detected and enumerated based on light scatter and absorbance measurements using the ADVIA 120 laser optics A scatter versus scatter and scatter versus absorbance cytogram is displayed with the thresholds and results automatically calculated for each sample Reportable parameters are WEC and RBC counts along with absolute and percentage counts for neutrophils lymphocytes monocytes polymorphonuclear PMN and mononuclear MN cells A research use only eosinophil count is also given Regulatory Information 9 33 REF 04274197 9 34 Bibliography Lee GR Bithell TC Foerster J Athens JW Lukens JN Wintrobe s Clinical Hematology Ninth edition Malverne PA Lea amp Febiger pp 1071 1809 and 1812 1993 Werman HA Brown CG White blood cell count and differential count Emergency Medicine Clinics of North America 4 41 58 1986 Aune MW Sandberg S Automated counting of white and red blood cells in the cerebrospinal fluid Clinical Laboratory Haematology 22 203 210 2000 Hayward RA Oye RK Are polymorphonuclear leukocytes an abnormal finding in cerebrospinal fluid Arch Intern Med 148 1623 1624 1988 Steele RW Marmer DJ O Brien
288. it is impossible to provide information that would be applicable to every clinical situation This information is provided in lieu of attempting to define the need for additional testing which involves medical judgement in individual cases The decision whether or not to report a diagnostic result rests with the laboratory Regulatory Information System Method Information Expected Values Ranges of expected values can vary depending on age sex diet location etc therefore it is recommended that each laboratory establish its own range of expected values System Method Information Performance Characteristics These topics provide technical information related to method performance characteristics including imprecision correlation data analytical range and carryover A description of each statistical parameter and the protocol followed to compute that parameter are as follows imprecision Imprecision is defined as the degree of variability among repeated measurements of the same sample Within run imprecision refers to the reproducibility of the method when samples are assayed within a single run The imprecision values for each method described on each of their respective Method Sheets are point estimates of average imprecision that can be expected on the system Because this is a point estimate any single system tested with a similar protocol could yield a different estimate of imprecision and yet not be significantly diff
289. itting infectious diseases Wear facial protection gloves and protective clothing 10 6 ADVIA Autoslide Slide Maker Stainer The operator should follow the recommendations to prevent the transmission of infectious agents in health care settings as recommended for potentially infectious specimens in Protection of Laboratory Workers from Infectious Disease Transmitted by Blood Body Fluids and Tissue 2d edition Approved Guideline 1997 Document M29 A National Committee for Clinical Laboratory Standards NCCLS This document contains complete information on user protection and it can be used as reference material for instructions on laboratory safety ELECTRICAL WARNING To avoid exposure to shock hazards or damage to the instrument while performing a procedure power off the analyzer before proceeding The following parts must not be handled or checked by the user e Electrical power supply e Electronic circuit boards Operator injury may occur from an electric shock Electronic components can shock and injure the user Do not temper with the instrument and do not remove any components covers doors panels etc unless otherwise instructed within this document gt WARNING Do not disable sensors Doing so may result in operator injuries Do not open the Autoslide doors or covers during instrument operation This causes the instrument to stop operation and cancel any running slides gt WARNING Do not disable se
290. just if necessary b Ifthe problem persists call Siemens Service for Status Line messages bottom of an improperly positioned rack Pushpin catches on the bottom of the mixer Faulty output queue sensor or wiring assistance Check rack position in mixer Adjust if necessary b If the problem persists call Siemens Service for assistance Call Siemens Service for assistance Autosampler Pushpin Jammed Pushpin is jammed and cannot extend or retract properly Possible Cause 1 Pushpin catches on bottom of improperly positioned rack Pushpin catches on bottom surface of mixer extrusion Corrective Action Check and adjust rack position in mixer AN CAUTION Call Siemens Service for assistance Only Siemens Service personnel are authorized to take this corrective action b Check output queue sensor and sensor wiring a Check and adjust rack position in mixer AN CAUTION Call Siemens Service for assistance Only Siemens Service personnel are authorized to take this corrective action b Check output queue sensor and sensor wiring Autosampler Rack Index Failed Reset Autosampler The scanner has read a valid barcode that does not correspond to the expected rack or position numbers This indicates that the rack has not moved to the proper position Status Line messages Possible Cause 1 Rack movement problem Corrective Action a Atthe analyzer touchpad select Off
291. k delivery of SHEATH RINSE 3 Check the RBC Baso Retic hydraulics EER WES 4 Check the retic hydraulics 5 Check retic gains Retic Slope Error RTC SE SE Definition The Retic Slope Error flag is triggered if the slope of the negative cell population on the absorption axis is greater than 0 2 before the slope correction is applied The negative cell population should appear parallel to the y axis on the RETIC Scatter Absorption cytogram Signals will not gate properly if they exhibit a backward or forward tilt Flags Normal Retic Scatter Abs Cytogram Results Flagged RETIC CHg CHr CHCMg CHCMr CHDWr CHDWg MCVg MCVr RDWg RDWr Corrective Action The following list may not contain all conditions that could cause this flag nor is there any intention to associate the flag with specific diagnoses e Aged blood e Sickle cell anemia Suspect Cellular Interference NRCELL NC Definition The Suspect Cellular Interference flag is triggered by of the possible presence of unlysed red blood cells The flag is raised when the Peroxidase channel WBC count WBCP is greater than the Basophil Lobularity WBC count WBCB by more than the specified limit Results Flagged NRBC NRBC WBC NEUT NEUT LYMPH LYMPH MONO MONO EOS EOS BASO BASO LUC LUC Both the NRBC Enumeration histogram and Noise lymph histogram often show no valley separating Noise events from the nRBC population or
292. l contains the largest number of cells in a particular population e The mode channel PMNx of the PMN population on the x axis 2 e The valley channel that separates the MN PMN populations 3 The valley channel contains the fewest number of cells between two populations relative depth of the valley as expressed by d D BASO d D e The Lobularity Index LI value provides an indication of sample abnormality The Ll is the PMN peak channel number on the Baso X histogram divided by 14 and it is greater than 1 9 for normal samples Values lower than 1 9 are usually indicative of sample abnormality BASO Y Histogram The BASO Y histogram displays the event distributions from the noise threshold to channel 49 on the y axis of the BASO cytogram However it contains only those events on the x axis up to the MN PMN valley channel of the BASO cytogram This will include the MN mononuclear population The BASO Y histogram is used to determine the mode channel MNy of the MN population on the y axis 8 5 8 6 BASO Cytogram Cluster Analysis The BASO cytogram is divided into 50 counting channels on each axis When the high angle light scatter nuclear configuration is plotted on the x axis and the low angle light scatter cell size is plotted on the y axis distinct populations or clusters are formed Cluster analysis identifies each population based on its position area and density and then counts t
293. l of the RETIC Scatter cytogram RTC Cells Acquired Number of Valid Signals Obtained RTC Cells Analyzed Cells on RTC Scatter cytogram with nonzero volume and hemoglobin values and are not in channel 99 RTC Gated Cells Neg RBC Retic Count within threshold limits Slope Negative Cells Slope of the negative mature RBC population relative to y axis of the RETIC Scatter ABS cytogram Parameter Key RETIC Absolute number of reticulocytes RETIC Percent of reticulocytes CHCMr Reticulocyte Cellular Hemoglobin Concentration Mean CHr Reticulocyte Cellular Hemoglobin Content MCVm Mean Cell Volume of mature population MCVr Mean Cell Volume of reticulocyte population RBC The system always uses the RBC count from the RBC Platelet method even when a sample has been run with a retic only selectivity RTC RBC Red blood cell count from the Reticulocyte method The RTC RBC count is calculated in the same manner as the RBC count from the RBC Platelet Method RTC Dead Time Percent of analysis time when the channel is busy and cannot detect flowcell events Methods Methods RTC Noise Percent of events from the outlier areas Outlier Cells The outlier cell count includes cells with high scatter values less than the RTC Platelet threshold and cells with high scatter values greater than the RTC Coincidence threshold RTC Gated Cells The number of cells between the RTC platelet and RTC coincidence
294. l solution 5 1 9 Calculations 5 1 9 1 Give stepwise instructions Regulatory Information Siemens Method Topics Control Package Insert Quality Control Control Package Insert According to Individual Laboratory Practice Quality Control According to Individual Laboratory Practice Quality Control if applicable Procedure Not applicable Not applicable Not applicable Procedure Performance Characteristics Calculations Not applicable Not applicable Calculations 9 19 9 20 CLSI Approved Guideline M29 A3 5 1 9 2 Give the equation 5 1 9 3 Give an example 5 1 10 Reporting results 5 1 10 1 State reference ranges 5 1 10 2 Identify procedures to be used in reporting results to the physician 5 1 10 3 Guidelines on acceptable reporting format 5 1 11 Procedure Notes 5 1 11 1 Explain reasons for special precautions 5 1 11 2 List possible sources of error 5 1 11 3 Include helpful hints 5 1 11 4 Clinical situations that may influence test validity 5 1 11 5 Acceptable alternative procedures expected differences 5 1 11 6 Enlarge upon clinical applications 5 1 12 Limitation of Procedure 5 1 12 1 State linearity and or detection limits 5 1 12 2 State known interfering substances 5 1 13 Bibliography 5 1 13 1 Literature references Siemens Method Topics Calculations Calculations Expected Values According to Individual Laboratory Practice Results According to I
295. leaned in the same way PEROX FLOWCELL RBC FLOWCELL SHUTTLE LINES SAMPLE vas LINES v27 WASTE 1 TO WASTE y LINES REAGENT REAGENT 1 Disconnect the sample tubing from the sample syringe and place the end into a beaker of 25 solution of household bleach 2 Atthe Utilities menu select the Exerciser tab and select Valves from the list on the left If you are cleaning the RBC flowcell select V23 and V27 If you are cleaning the perox flowcell select V25 and V24 3 Allow alternate segments of air and bleach solution to be pulled through the sample line 4 Put water into a beaker and flush the line clean by allowing water to be pulled through the line 5 Replace the sample line and close all valves 6 clean the sheath or shuttle lines follow the same procedure When cleaning the sheath line remove tubing from V15 for the perox sheath line or V19 for the RBC sheath line When cleaning the shuttle line remove the tubing from the UFC fitting Cleaning the Flowcells off the Analyzer Clean the flowcell When there is a clog in the flowcell or in the Concentric Flow Module CFM When the flowcell windows are dirty Materials required ADVIA OPTIpoint ADVIA TESTpoint controls FZ KLEEN PN 01 3624 e Flowcell Cleaning Kit PN 113 B711 01 Kit includes Troubleshooting the Analyzer Drill bit e Needle cleaning kit PN 113
296. lections and create a new workorder through the Order Entry window Status Line messages 7 49 7 50 HGB Colorimeter Error Reset Required Potential software communication error or a hardware failure associated with the HGB Colorimeter Possible Cause Corrective Action 1 Hardware Reset the analyzer by selecting Utilities Exerciser failure Indicators Analyzer Reset b After about 1 minute if the status line does not display Ready to Run and the green ready to aspirate light is still off follow these steps to exit the ADVIA 2120 21201 software turn off the analyzer and then restart i Select Shut Down at the Log On Off window ii Select Off at the analyzer touchpad iii Select CTRL ALT DELETE and log back onto the system to restart the software iv Restart the analyzer by selecting On at the analyzer touchpad 2 Faulty power Call Siemens Service for assistance supply fuse cable HGB Interface Node Board or Can Bus Scrambler Board HGB Concentration Variance Alarm The number of consecutive occurrences of this condition has met the criterion specified for an alarm message The specified alarm criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Alarm Criteria is automatically reset HGB Concentration Variance Stop The number of consecutive occurrences of this condition has met the criterion specified for a stop message The aut
297. licon used to lubricate the stoppers of blood collection tubes e RBC coincidence events in samples with RBC counts greater than 1500 cells uL may cause falsely elevated CSF WBC counts and incorrect CSF WBC differentials Such a sample should be diluted to acceptable RBC limits in PBS before preparation with CSF Reagent and reanalyzed e RBCs in samples that have been diluted with normal saline before preparation with CSF reagent require a longer incubation period to sphere the RBCs in the sample The preferred diluent for CSF samples is PBS Samples diluted with normal saline must be prepared with CSF reagent immediately after dilution and must be incubated for 10 minutes in order to allow complete RBC sphering e Samples containing microcytic and or hypochromic RBC populations may falsely decrease the CSF RBC count e Samples containing RBC populations that fail to sphere completely may give falsely elevated CSF WBC counts and incorrect CSF WBC Differentials e Budding yeast forms may overlay both CSF RBC and CSF WBC counting areas falsely elevating CSF RBC and WBC counts Expected Values The range of expected values for the CSF Assay can vary depending on patient age or other patient characteristics It is recommended that each laboratory establish its own range of expected values based on their patient population The following range of expected values is based on ADVIA 120 results from 52 CSF specimens that were determined to be norm
298. ll particles of glass may be chipped off the slides during transfer from the slide dispenser to the slide carrier These particles are collected in a tray beneath the slide dispenser To remove glass particle waste AN WARNING Use caution when handling or troubleshooting objects with sharp edges The edges may cut and cause injury 1 Using both hands carefully pull the tray beneath the slide dispenser toward you and remove it ADVIA Autoslide Slide Maker Stainer 10 37 2 Discard the glass particles according to your standard laboratory procedures 3 Replace the tray securely under the slide dispenser 10 38 ADVIA Autoslide Slide Maker Stainer Cleaning the Stain Overflow Tray BIOHAZARD All products or objects that come in contact with human or animal body fluids should be handled before and after cleaning as if capable of transmitting infectious diseases Wear facial protection gloves and protective clothing The operator should follow the recommendations to prevent the transmission of infectious agents in health care settings as recommended for potentially infectious specimens in Protection of Laboratory Workers from Infectious Disease Transmitted by Blood Body Fluids and Tissue 2d edition Approved Guideline 1997 Document M29 A National Committee for Clinical Laboratory Standards NCCLS This document contains complete information on user protection and it can be used as reference material for instructions on la
299. logy System Stand alone waste container Automatic Waste Removal P 4 4 4 4 I oc lt How the ADVIA 2120 2120 Hematology System Works Blood samples can be aspirated through the Autosampler e Manual closed tube sampler e Manual open tube sampler After a sample 4 is aspirated it is drawn into the shear valve 5 As the shear valve rotates it shears or divides the sample into aliquots for the different types of tests Rinse Trapped in Lines Lines that are Dry Lines with Sample Line with Vacuum Conductivity Detector FA Rinse Source T Probe Vacuum Source The reagents and sample segments are delivered to their respective reaction chambers for mixing and aspiration PEROX 2 and PEROX 3 reagents are delivered directly to the perox reaction chamber Welcome to the ADVIA 2120 2120i Hematology System 1 15 Once the cytochemical reactions are complete in the reaction chambers the sample and reagent mixtures from the perox RBC baso and retic reaction chambers are sent to the flowcells for analysis The Hgb reaction chamber serves as an optical cuvette through which the hemoglobin measurement is read After analysis the sample and reagent mixture is evacuated into the waste container and the appropriate pathways and reaction chambers are rinsed Test results are sent to the computer to be reviewed and edited How the ADVIA 2120 2120i Software Works 1 16 The
300. lood Body Fluids and Tissue 2d edition Approved Guideline 1997 Document M29 A National Committee for Clinical Laboratory Standards NCCLS This document contains complete information on user protection and it can be used as reference material for instructions on laboratory safety To clean the syringes and plungers 1 Remove the syringe a Turn the thumb wheel 1 counterclockwise until the plunger is lowered about 1 2 inch 1 27 cm b Disconnect the input 2 and output 3 fittings from the syringe head c Remove the nut and washer that secure the syringe at the top Slide the syringe barrel down toward the bottom of the carriage to clear the mounting hole then remove Maintaining the Analyzer 4 11 A CAUTION When cleaning the 50 uL syringe never pull the plunger through the small plastic bushing inside the syringe This will cause damage to the syringe plunger tip Use a small hex wrench to pop the bushing all the way out of the syringe then remove the plunger from the syringe with both bushings still on the plunger stem Do not remove the plastic bushings from the 50 uL plunger 2 Remove the dirty plunger from the syringe Do not remove the white bushing from the plunger or the plunger from the stainless steel barrel bushing on the bottom Using a soft lint free tissue gently wipe the plunger tip Make sure all debris is removed from the grooves 3 Thoroughly rinse the syringe barrel with wa
301. losed Avoid contact with skin Wear suitable protective clothing and R39 23 24 25 gloves In case of accident or if you feel unwell seek medical advice S7 24 immediately show the label where possible Contains methanol 9 Toxic Toxic danger of very serious irreversible effects through 36 37 S45 8 Highly Flammable Highly flammable Keep away from sources of ignition No smoking Contains methanol R11 S16 Stain 2 Giemsa Stain e Methanol 56 e Glycerol 43 e Methylene blue Eosin 1 ADVIA Autoslide Slide Maker Stainer Amount 4x2 5L 6x0 5L 4x2 5L 4x2 5L 10L 10 23 Toxic Toxic danger of very serious irreversible effects through 9 inhalation in contact with skin and if swallowed Keep container tightly closed Avoid contact with skin Wear suitable protective clothing and R39 23 24 25 gloves In case of accident or if you feel unwell seek medical advice S7 24 immediately show the label where possible Contains methanol 36 37 S45 5 Highly Flammable Highly flammable Keep away from sources of ignition No smoking Contains methanol R11 516 May Gr nwald Buffer e Phosphate buffer e Preservative Methanol e Methyl Alcohol gt 99 8 Toxic Toxic danger of very serious irreversible effects through inhalation in contact with skin and if swallowed Keep container tightly closed Avoid contact with skin Wear suitable protective clothing and R39 23 24 25 g
302. loves In case of accident or if you feel unwell seek medical advice S7 S24 immediately show the label where possible Contains methanol 36 37 S45 Highly Flammable Highly flammable Keep away from sources of ignition No smoking Contains methanol R11 516 Reagent Storage and Stability Store Stains Buffer and Methanol tightly closed between 15 C and 25 Cover open reagent bottles with Parafilm or equivalent to avoid excessive evaporation When unopened reagents are stable until the expiration date printed on the product label when stored at room temperature between 15 C and 30 C Once opened reagents are stable for 45 days Do not refrigerate Refer to the online ADVIA 2120 2120i Operator s Guide for information on specimen collection 10 24 ADVIA Autoslide Slide Maker Stainer Material required but not provided Microscope slides 26 x 76 x 1 mm Size 76 x 26 x Imm Description ground edges rounded corners super frost Use slides provided by Siemens approved vendors only Limitations May Gr nwald Giemsa reagents produce high quality stained blood films However there may be personal preferences in shades and intensities of staining not satisfied by the system Results When used with the ADVIA Autoslide Slide Maker Stainer the May Gr nwald Giemsa reagents will produce a consistent stain quality to facilitate accurate and reliable interpretation Technical Assistance For customer s
303. ls 0 and 8 on the y axis Cluster Analysis Histogram Analysis noise cluster 2 noise area Results Flagged WBC WBCB BASO BASO Corrective Action Multiple occurrences of this flag especially for consecutive samples can indicate a system problem However isolated instances of this flag are usually sample related The following list of sample related causes may not contain all conditions that could cause this flag There is no intention to associate the flag with specific diagnoses 6 27 System Related Sample Related 1 Check baso reagents e Lipemia 2 Check baso hydraulics e High WBC count 3 Check the pressure and vacuum readings e Extreme eosinophilia 4 Check sheath delivery e Malaria parasites 5 Check the baso reaction chamber e Aged Blood temperature 6 Check RBC Baso Retic flowcell alignment Baso No Valley B NV VB Definition The Baso No Valley flag is triggered if there is no valid separation between the mononuclear MN and polymorphonuclear PMN populations in the Baso cytogram The B NV VB flag is not triggered if agreement between the baso and perox results is indicated by both the following conditions e WBCB WBCP agree within specified limits No WBC CE flag EOS PMN is between 0 and 7 5 Separation of the MN and PMN populations along the x axis of the Baso cytogram is evaluated by the relative depth of the valley between the two populations In normal
304. luid CSF specimens The CSF assay provides leukocyte CSF WBC and erythrocyte CSF RBC counts as well as absolute and percentage counts for the CSF WBC differential To arrive at a diagnosis and a course of treatment results from the CSF assay should be used in conjunction with other diagnostic information and the attending health care professional s evaluation of the patient s condition Principles of the Procedure Hematological analysis of CSF specimens has historically been performed in laboratories using manual cell counting and differentiation methods Blood cells in normal CSF samples are usually present in very low numbers The WBC count can provide important clinical information for the differential diagnosis of various cerebral diseases The WBC count in CSF is used in the diagnosis of bacterial meningitis differential diagnosis of viral and fungal meningitis encephalitis neurological disorders the diagnosis of leukemias with CSF involvement and for monitoring patient therapy for leukemias and lymphomas An elevated WBC count with increased proportions of polymorphonuclear cells is usually an indication of bacterial meningitis In viral meningoencephalitis the cell counts may be lower with a predominance of mononuclear cells An unusually elevated RBC count can be an indication of cerebral hemorrhage or a traumatic spinal tap The ADVIA 120 CSF assay provides a rapid automated analysis of CSF samples by counting and distingu
305. lure status indicates that intervention is required to continue using the Autoslide The Warning status indicates intervention is required to prevent an eventual failure If the suggested actions described below do not resolve the problem call your technical support provider or distributor TIP 1 The Autoslide may not respond immediately to a command under certain circumstances it may take up to 30 seconds for a response from the system This is due to communication restraints between the ADVIA 2120 2120i system and the Autoslide It is important to allow time for the system to respond DO NOT keep clicking the mouse TIP 2 In addition to clearing the source of the problem such as removing a jammed rack etc check the Autoslide Status Screen when an error occurs If both the stainer and smearer are RED and there are no slides in the stainer a MECHANICAL INITIALIZATION homes both smearer and stainer must be performed If only the smearer is RED a RESET SMEARER restores the system to Ready GREEN and allow any slides currently being stained to continue processing TIP 3 If the Autoslide status screen shows RED for the stainer and slides were being processed a RESET AUTOSLIDE performs a mechanical initialization then drains and removes the slides TIP 4 Autoslide Error Messages are logged to the message log in the order they occur If a critical error is displayed go to the postings just before the critical error a
306. mL 09170071 T03 3685 52 Hematology 2x 6 1 mL Calibrator T03 3685 01 CAL Hematology 6 1 mL Calibrator System Method Information Calibration This topic specifies the calibration type frequency and procedure for each method and identifies the calibration material to be used where appropriate Calibration Procedure The system must be calibrated for all parameters except Retics Siemens recommends the use of ADVIA SETpoint Calibrator Prod No T03 3685 01 Calibration should be performed in each of the following cases e Upon installation of the system e If there is a significant shift in control values after the replacement of a critical hardware component or reagent lot after checking gains e Anytime control results and or moving averages are out of range and it has been verified that the out of control condition is instrument related System Method Information Results This topic describes expected flags or messages associated with analytical results System Method Information Limitations of the Procedure This topic describes substances conditions and patient states that have been reported to cause actual or apparent changes in the analytical results Siemens makes every effort to identify in the Troubleshooting Maintenance and Bibliography topics of the Product Labeling the potential effects caused by instruments reagents or endogenous substances including known interferences on patient results However
307. mage Download Software communication error or possible faulty Ethernet cable from the analyzer J2 Workstation connection to the computer Corrective Action Follow these steps to exit the ADVIA 2120 2120i software and then restart 1 Select Shut Down ADVIA at the Log On Off window 2 Select CTRL ALT DELETE and log back onto the system to restart the software If the problem persists verify that the Ethernet connection is secure and replace if necessary If the problem recurs call Siemens Service for assistance Invalid Unknown TDC Error An unrecognized Data Manager error has occurred Corrective Action Follow these steps to exit the ADVIA 2120 2120i software and then restart 1 Select Shut Down ADVIA at the Log On Off window 2 Select CTRL ALT DELETE and log back onto the system to restart the software If the problem persists call Siemens Service for assistance Invalid Configuration Mandatory Field Missing The configuration file is incorrect A mandatory field is missing Corrective Action On the Screen Configuration window correct the configuration file Select Customize menu System Setup Tools Modify Screen Configuration Invalid Host Test Number 0 A test has an improper host number defined in the Test Dictionary Corrective Action Verify host number in Test Dictionary Characteristics Invalid Morphology Flags Host Number xxx The morphology flags from the analyzer cannot be managed by the Data
308. matically aspirated the sampling light flashes c When the sampling light stops flashing remove the tube 5 Evaluate control results or validate patient results when available Daily Routine 3 7 3 8 To run samples from the manual open tube sampler 1 2 If the Standby indicator is lit select Standby Run samples in the following order e Whole blood primer primer label e Controls control label e Patient samples sample ID label Scan the tube label or enter the sample information in the Manual Sample ID tab aspirating a sample using either the manual open tube sampler or the manual IMPORTANT Make sure the correct sample ID appears the status line before 4 5 closed tube sampler Waiting appears on the status line while the system searches for a matching workorder Make sure the correct sample selectivity appears on the status line If you run a control with a mismatched selectivity Example running a CBC Diff control with a Retic selectivity the results will not appear in the Review Edit tab and in some cases the system computer may require a restart Aspirate the sample a Position tube so that the sampler probe is immersed into the well mixed sample b Immerse the sampler probe only deep enough approximately 0 25 in to ensure aspiration c Press the aspirate plate The sampling light flashes during aspiration d When the sampling light stops flashing remove the tube
309. mation 11 Damage was caused by electrical surges or voltages exceeding the tolerances outlined in the system operator s manuals 12 Damage was caused by water from any source external to the instrument 13 The customer has purchased an alternative agreement whose terms of warranty or service supersede these provisions Siemens or its authorized distributors can invoice customers at current standard labor and parts rates for instruments repaired to correct damage or malfunctions due to any of the reasons listed above OTHER THAN AS STATED ABOVE THERE ARE NO OTHER WARRANTIES EXPRESS OR IMPLIED WITH RESPECT TO THE INSTRUMENT ITS SALE TO THE CUSTOMER ITS LEASE TO THE CUSTOMER OR THE SALE OF THE INSTRUMENT TO THE CUSTOMER AT THE EXPIRATION OR TERMINATION OF THE LEASE AGREEMENT SIEMENS HEALTHCARE DIAGNOSTICS SPECIFICALLY DISCLAIMS ANY AND ALL IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR USE OR PURPOSE SIEMENS HEALTHCARE DIAGNOSTICS LIABILITY FOR BREACH OF ANY WARRANTY OR SERVICE AGREEMENT SHALL BE LIMITED ONLY TO THE REPAIR OR REPLACEMENT OF DEFECTIVE EQUIPMENT AND SHALL NOT INCLUDE ANY DAMAGES OF ANY KIND WHETHER DIRECT INDIRECT INCIDENTAL CONTINGENT OR CONSEQUENTIAL SIEMENS SHALL NOT BE LIABLE FOR DELAY FROM ANY CAUSE IN PROVIDING REPAIR OR EXCHANGE SERVICE ANY LIMITATIONS OR OTHER PROVISIONS NOT CONSISTENT WITH APPLICABLE LAW IN PARTICULAR JURISDICTIONS OR A SPECIFIC WRITTEN AGREEMENT DO NOT
310. me Measured Sample Time Methods Methods Parameter RTC Noise Mean Absorption ABS Low Cell Count ABS Mode RTC Valid Cells Explanation 100 x Outlier Cells RTC Cells Analyzed Mean of the RETIC Abs histogram for the reticulocyte population Counts in x axis channels to 3 of the RETIC Scatter Abs cytogram Mode channel of the Absorption population Number of Valid Signals Obtained from Flowcell Events Additional Parameters The following parameters are for research or laboratory use only and are not for patient reporting Parameter CHCMr MCVm MCVr Neg RBC Neg RBC Retic Count LRetic LRetic MRetic MRetic HRetic HRetic IRF H Explanation Mean of the Retic HC histogram for the reticulocyte population Mean of the RETIC Volume histogram for the mature population Mean of the RETIC Volume histogram for the reticulocyte population Number of mature RBCs 100 x Neg RBC RTC Gated Cells Number of reticulocyte events Number of low absorption reticulocytes 100 x RETIC Count Number of medium absorption reticulocytes 100 x RETIC Count Number of high absorption reticulocytes 100 x HRetic RETIC Count 100 x HRetic RETIC Count 8 67 8 68 Parameter Explanation IRF M H 100 x MRetic RETIC Count RTC Mean X Mean x channel of the RETIC Scatter cytogram RTC Mean Y Mean y channe
311. mode channel of the noise population on the y axis 1 e The peak channel Lymph Mode of the lymphocyte population on the y axis 2 e valley channel Noise Lymph Valley that separates the noise and Iymphocyte populations 3 The relative depth of the valley as expressed by d D PEROX d D A Noise B Lymphocytes PEROX Cytogram The PEROX cytogram is divided into 100 counting channels on each axis The cells absorb light proportional to the amount of peroxidase stain present and this is represented on the x axis Cells scatter light proportional to their size and this is represented on the y axis When the light scatter and absorption data are plotted distinct populations or clusters are formed Cluster analysis identifies each population based on its position area and density and then the number of cells in each population is processed The lines that separate the different cell populations are calculated by the software on a sample by sample basis Methods Methods The following PEROX cytograms were obtained from a representative patient specimen 1 Noise 5 Large Unstained Cells 2 Nucleated Red Blood Cells 6 Monocytes 3 Platelet Clumps 7 Neutrophils 4 Lymphocytes and Basophils 8 Eosinophils Noise This area contains Platelets RBC stroma and debris that are excluded from the Total White Count WBCP and WBC differential Nucleated Red Blood Cells If present nucleated red blood cells appear in thi
312. more than one window Click these buttons to open the corresponding windows within a tab Main display area When you select an item from a menu or click a tab the corresponding window appears below the tabs in this area You can usually switch from one window to another by simply opening the one you want Some windows however do not close automatically and require that you click an Exit button before you change to a new one Bottom buttons These buttons activate commands or manipulate the contents of the window Help button When you need detailed Help that provides step by step instructions for operating the ADVIA 120 click the Info button To get brief What s This Help click the icon on the status line or press the Shift and F1 keys at the same time then click the item for which you want help Shortcut keys Click these buttons to open frequently used software tabs without using the menus You can choose the tabs for which there are buttons using the Shortcut Key Configuration window of the System Setup tab Wizards The software has wizards to help you with complicated procedures Each wizard guides you through a process by giving you information and prompting your input along the way You also have the option to perform these procedures without the help of a wizard Welcome to the ADVIA 2120 2120i Hematology System Printing the screen IMPORTANT You can print any screen by pressing the Print Screen key However
313. mpler Motion Request Failed Reset Autosampler The autosampler failed to perform a requested motion and might be defective An autosampler reset is required Corrective Action 1 Select Off at the analyzer touchpad 2 Wait about 1 minute and select On to restart the analyzer 3 If the problem persists call Siemens Service for assistance Autosampler Motor Controller Failed Reset Autosampler The autosampler motor controller failed to respond to a routine command and might be defective An autosampler reset is required Corrective Action 1 Select Off on the analyzer touchpad 7 28 Status Line messages 2 Wait about 1 minute and select On to restart the analyzer 3 If the problem persists call Siemens Service for assistance Autosampler Needle Extend Denied To prevent the collision of autosampler components the system did not execute the command to extend the autosampler needle Autosampler Needle Failed to Extend Reset Autosampler The autosampler needle failed to extend properly Possible Cause Corrective Action 1 Critical a Open the autosampler access door Sampler b Close the autosampler access door The autosampler Error will reset Ifthe problem persists select Off on the analyzer touchpad d Wait about 1 minute and select On to restart the analyzer e Ifthe problem persists call Siemens Service for assistance 2 40 PSI line is out of range Check pressure and adjust if necessar
314. mum of eight hours After the laboratory shift with the largest number of samples run three system wash cycles after other shifts you need to run only one wash cycle In addition if the number of samples in a shift exceeds 400 perform one system wash after the 400th sample 1 Atthe Utilities menu select Hydraulic Functions 2 Select System Wash select 1 for the Number of Cycles and then select Start Performing the End of Day Procedure To reset SIDs and close out the QC and Moving average statistics Tools View 1 At the Customize menu select Tools View 2 When the tools list displays double select End Of Day 3 Select Yes to confirm that you have finished the workload If saved the selections from a previous End of Day operation now appear 4 Select the SID RESET check box to perform a SID RESET 5 Ifdesired select the Close Out check box to transfer the daily QC file into the Cumulative QC file Use the list box to select close out for all controls or a specific control 6 Ifdesired select the MOV AVG Close Out check box to obtain a cumulative data point from moving average control statistics with a date earlier than the date in the Up to box 7 Select OK to confirm and start To also backup and purge the data files Tools Modify 1 At Customize menu select System Setup and then select Tools Modify 2 When the tools list displays double select End Of Day 3 Select the SID RESET check box t
315. n using the manual open tube sampler After appropriate incubation mix the sample again either by inverting it 5 10 times or by vortexing it for 5 seconds immediately before aspiration on the ADVIA 120 Hematology System Cells in prepared CSF samples will settle quickly due to low viscosity 9 37 REF 00872863 9 38 10 Aspirate the sample a Position tube so that the sample probe is immersed into the well mixed sample The sample probe should not contact test tube surface which could block the free flow of sample into the probe b Press the aspirate plate The sampling light flashes during aspiration Complete sample aspiration takes approximately 6 seconds and will consume almost the entire prepared sample Do not remove sample until sampling light has stopped flashing There is no Probe Clog message to indicate incomplete sample aspiration in the CSF mode Carefully observe the sample during aspiration to ensure that the sample probe is below the surface of the sample during the entire aspiration c When the sampling light stops flashing remove the tube 11 When the analysis of all CSF samples is complete and you would like to return to whole blood operation select Exit The system automatically returns to the Whole Blood Manual Sample ID window When you exit CSF operation after running at least one sample or any cycle the system asks if you are sure you want to exit Select OK to leave the Cerebrospinal Fluid CS
316. n Macrocytic region 60 fL marker 2120 2120i fL marker oa A WN RBC Volume histogram anisocytosis o0 0 o0 0 Microcytic region Normocytic region Macrocytic region 60 fL marker 120 fL marker a A O N RDW is monitored as an indication of anisocytosis and the results are flagged if the RDW exceeds 16 Note that two specimens with the same RDW value can have different degrees of microcytosis and macrocytosis 8 41 8 42 RBC HC Histogram The RBC hemoglobin concentration RBC HC histogram represents the distribution of red blood cells by cellular hemoglobin concentration The histogram has a range of 0 g dL to 50 g dL RBC HC histogram normal sample 2 L3 1 Hypochromic region Normal samples have a bell curve shaped Hgb concentration distribution with a mean channel between 28 g dL and 41 g dL The cell hemoglobin concentration mean CHCM and the hemoglobin distribution width HDW are obtained from this histogram The CHCM is the mean of the RBC HC histogram The HDW is the standard deviation of the RBC HC histogram The CHCM calibration factor has been applied to the displayed data Normochromic region N 28 g dL marker 41 g dL marker oA RBC HC histogram hypochromic sample a 1 Hypochromic region In samples with increased numbers of hypochromic RBCs the histogram curve shifts to the left indicating an increase in
317. n gloves and protective clothing The operator should follow the recommendations to prevent the transmission of infectious agents in health care settings as recommended for potentially infectious specimens in Protection of Laboratory Workers from Infectious Disease Transmitted by Blood Body Fluids and Tissue 2nd edition Approved Guideline 1997 Document M29 A National Committee for Clinical Laboratory Standards NCCLS This document contains complete information on user protection and it can be used as reference material for instructions on laboratory safety Time 15 minutes Materials required i q x 1 e Cotton swab 28V Deionized water e Paper towels e Squirt bottle Analyzer mode Off To clean the autosampler aspirate assembly 1 Turn off the analyzer 2 Tilt the front cover down 3 Thoroughly rinse the autosampler aspirate assembly with deionized water NOTE Single aspirate assemblies have one needle centering collar and air cylinder 4 Remove the sample line 1 from the bottom of the needle base A CAUTION Maintaining the Analyzer Maintaining the Analyzer You must remove the sample line before the aspirator assembly is tilted forward If the line stays in place it can break as the assembly is tilted Loosen the thumb screws 2 and tilt the autosampler aspirator assembly forward then thoroughly rinse the back side of the assembly with deionized water
318. n a cycle by cycle basis The SHEATH RINSE is in CUBITAINER placed on the floor Vacuum and Pressure Regulator Knobs 20 In Hg 5 PSI Vacuum Regulator Pressure Regulator Knob Knob 20 PSI 40 PSI Pressure Regulator Pressure Regulator Knob Knob Touchpad PERS UEM lt e D O p Start Stop Eject On Standby Sampler Rack Rack in Sampler The touchpad located on the lower right of the analyzer is the means by which you operate the analyzer On Provides power to the analyzer assemblies and power supplies After On is pressed samples through the manual open and closed tube samplers can be processed within 2 5 minutes while samples through the autosampler can begin processing within four minutes Standby Sets the analyzer to a lower power state To exit press Standby Welcome to the ADVIA 2120 2120i Hematology System Start Stop Sampler Starts the autosampler operation from the Ready to Run mode or stops the autosampler When the autosampler operation is stopped samples underway are allowed to finish Eject Rack Moves all racks within the autosampler into the output queue The analysis of the last sample aspirated is completed Rack in Sampler Lights up when a sample rack is in the autosampler including the input queue Off Turns off the power to all analyzer assemblies and power supplies except the touchpad Touchscreen The touchscreen monitor makes it possible for you to per
319. n at the analyzer touchpad 2 PEROX SHEATH Follow the steps in Replacing the Syringe Plungers syringe incorrectly assembled 3 Faulty power Call Siemens Service for assistance supply fuse cable pump assembly Can Bus Scrambler Board or Dual Servo Pump Control Board Status Line messages 7 73 7 74 PEROX SHEATH Reagent Empty Stop The number of consecutive occurrences of this condition has met the criterion specified for a stop message The reagent is empty and the autosampler has halted The specified alarm criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria Reagent Conditions Corrective Action The stop counter is automatically reset after reagents are replenished and the Reagent Installation window is updated Go to Logs Reagent Log Reagent Installation Select Start Stop to continue the run PEROX SHEATH Reagent Expired Present date is beyond the PEROX 3 SHEATH reagent expiration date as determined by encoded reagent container barcode label or as calculated from installation date and open container stability Corrective Action Replenish expired reagents and update the Reagent Installation window Go to Logs Reagent Log Reagent Installation PEROX SHEATH Reagent Low Alarm The number of consecutive occurrences of this condition has met the criterion specified for an alarm message indicating that the reagent level is low The specified alarm criterion is user definabl
320. n of the staining protocol 1 2 3 4 5 6 7 8 9 10 11 Dispensing Modified Wright or Wright Giemsa Stain DN1 Slide introduction Draining Modified Wright or Wright Giemsa Stain AN3 Dispensing diluted Modified Wright or Wright Giemsa Stain DN3 Draining AN7 Dispensing rinsing solution distilled water DN7 Draining AN7 9o Dispensing rinsing solution distilled water DN7 Draining AN4 10 Dispensing methanol DN4 11 Slide removal Needle Position Action DNI Undil Stain 1 32 1 DN2 Buffer 22 0 DN3 Dil Stain 2 8 1 DN4 Methanol 31 0 DN7 Rinse 24 2 AN2 22 0 AN3 8 1 AN4 31 1 AN7 24 2 NOTE Needles AN2 and DN2 in position 22 are unused in this protocol Methanol Volume mL 1 6 Stain Volume mL 3 6 Dilution Ratio 25 ADVIA Autoslide Slide Maker Stainer 10 27 10 28 Duration Long Principle of the Procedure The stained smear is examined microscopically the nucleus and the cytoplasm of neutrophils lymphocytes monocytes eosinophils and basophils show a characteristic blue or red coloration Cells are then manually differentiated and quantified Cell Type Cell Component Neutrophils Nuclei Cytoplasm Granules Lymphocytes Nuclei Cytoplasm Monocytes Nuclei Cytoplasm Granules Eosinophils Nuclei Cytoplasm Granules Basophils Nuclei Cytoplasm Granules Platelets Cytoplasm Granules Red Blood Cell
321. n stored closed in their original containers at 2 C to 8 C Gain Adjustment The gain adjustment procedure is used to adjust the amplification signals in a channel to properly position the cell signatures within a cytogram Calibration The system must be calibrated for all parameters except Siemens recommends the use of ADVIA SETpoint Calibrator Prod No T03 3685 01 Please refer to page 5 for product descriptions Calibration procedure should be performed e Upon installation of the system e If there is a significant shift in control values after the replacement of a critical hardware component or reagent lot after checking gains e Anytime control results and or moving averages are out of range and it has been verified that the out of control condition is instrument related Regulatory Information 9 49 9 50 Sample Handling Sample Collection Collect whole blood in an evacuated blood collection tube containing EDTA as an anticoagulant Blood samples should be refrigerated at a temperature from 2 C to 8 C if they will not be analyzed within eight 8 hours of phlebotomy If a specimen has been refrigerated allow it to equilibrate slowly to room temperature 15 C to 30 C before analysis Sample Dilution Whole blood specimens with values exceeding the analytical range may be diluted with autologous plasma or isotonic saline and reassayed Sample Stability The effect of the aging of blood was stu
322. n the Sample System Flag Analysis panel of the Run Screen Triggering Criteria CBC CBC DIFF CBC RETIC DIFF RETIC RETIC Events above the upper Y Y MN PMN threshold on y axis and in channels 0 to 49 on x axis 2 5 Baso Flatness 2 5 Baso Noise gt 10 1 BASO d D lt 0 15 Y Y v v 2 Flag is not set if there is WBC agreement no WBC CE flag and EOS PMN is between 0 and 7 5 1 Baso Saturation gt 2 5 Y Y Y 4 2 Flag is not set if there is WBC agreement no WBC CE flag Baso chamber v Y v temperature is not between 31 9 C and 34 1 C 2 Flag is not set if there is WBC agreement no WBC CE flag and EOS PMN is between 0 and 7 5 MCHC CHCM gt 1 9 Y 6 21 Flag HGBIFR AR HGB PL PH LAS PL PL NRCELL NC NR LPD NL NRLPLT NP NRPXNV PLT NO NT PLTORN OT PX NV VX PXIFR XR 6 22 Triggering Criteria HGB Sample Flatness gt 1000 HGB baseline is not between 2 5 and 4 1 Laser light intensity 150 WBCP WBCB 1 1 1 BASO Noise gt 2 2 BASO Noise x WBCB gt 10 LPLT gt 40 x 10 uL No valley between the NRBC and lymphocyte populations and a reportable NRBC count 1 LPLT and ANISO flags are triggered any severity level 2 LPLT and MICRO flags are triggered any severity level Events in the Platelet Origin Noise area are gt 2 of the total event
323. nd click on Details for additional information about the problem 5 If for any reason the power needs to be cycled to the Autoslide allow the instrument reconnect the communication link with the ADVIA 2120 2120i system do not interrupt IMPORTANT The table below Event cause suggested actions supercedes the table currently displayed in the Operator s Guide ADVIA Autoslide Slide Maker Stainer 10 47 Event Text Severity Probable Cause Suggested Action ASL Aspiration needle Failure Aspiration needle failed to retract Perform Mechanical Initialization to retract timeout in time reset autoslide check autosampler if necessary perform an autosampler reset or power the ADVIA 2120 21 20i system off on ASL Command Timeout Failure Command timeout on autoslide Perform Mechanical Initialization to Stop Run stopped if Alarm Stop criteria reset autoslide Cycle power to Set for critical error Autoslide if problem persists call Siemens ASL Communications Failure Communication lost between Check serial I O cable between error Analytical Module and Autoslide instrument and autoslide and cycle autoslide power perform a mechanical initialization ASL Configuration Failure An invalid parameter was used to Perform Mechanical Initialization to Parameter error configure the Autoslide reset autoslide and report problem to Siemens ASL Critical Error Stop Failure General
324. nd standard deviation SD are calculated 3 The RTC Platelet threshold 1 is set at the mean channel minus 3 5 SD to separate the platelets from the mature RBCs and reticulocytes 4 The RTC Coincidence threshold 2 is set at the mean channel plus 3 5 SD to separate the coincident cells from the mature RBCs and reticulocytes The RTC threshold 3 on the x axis is set as follows Methods 1 The analyzer scans for the absorption mode between channels 2 and 25 the x axis 2 The standard deviation SD of the six channels on either side of the mode is calculated 3 RTC threshold is set 3 2 SD from the mode channel to separate the mature RBCs from the reticulocytes Two additional thresholds 4 5 are set on the x axis to separate the reticulocyte population by their stages of maturation The youngest reticulocytes have the highest amounts of RNA absorption and appear further out on the x axis 1 RTC threshold channel is subtracted from 75 and the resulting difference is divided by three 2 The Low Medium RTC threshold 4 is set to the RTC threshold channel plus the value calculated in step 1 3 The Medium High RTC threshold 5 is set to the Low Medium RTC threshold channel plus the value calculated in step 1 V Cytogram On the V HC cytogram hemoglobin concentration is plotted along the x axis and cell volume is plotted along the y axis Cells identified as mature RBCs
325. nd then restart i Select Shut Down at the Log On Off window ii Select Off at the analyzer touchpad iii Select CTRL ALT DELETE and log back onto the system to restart the software iv Restart the analyzer by selecting On at the analyzer touchpad Follow the steps in Replacing the Syringe Plungers Call Siemens Service for assistance RBC Sheath Pump Error Reset Required RBC Sheath syringe pump not in home position failed to respond or a transmission error occurred 7 82 Status Line messages Possible Cause Corrective Action 1 RBC Sheath Reset the analyzer by selecting Utilities syringe pump Exerciser Indicators Analyzer Reset not movie Or b After about 1 minute if the status line not n home does not display Ready to Run and the position green ready to aspirate light is still off follow these steps to exit the ADVIA 2120 21201 software turn off the analyzer and then restart i Select Shut Down at the Log On Off window ii Select Off at the analyzer touchpad iii Select CTRL ALT DELETE and log back onto the system to restart the software iv Restart the analyzer by selecting On at the analyzer touchpad 2 RBC Sheath Follow the steps in Replacing the Syringe syringe Plungers incorrectly assembled 3 Faulty power Call Siemens Service for assistance supply fuse cable pump assembly Can Bus Scrambler Board or Dual Servo Pump Control Board Ready to Run The sy
326. nditions 5 1 5 Reagents 5 1 5 1 List reagents supplies and equipment 5 1 5 2 Directions for preparation 5 1 5 3 Parameters used to determine acceptable reagent performance 5 1 5 4 Storage requirements 5 1 6 Calibration 5 1 6 1 Standard preparation 5 1 6 2 Calibration procedure 5 1 7 Quality Control 5 1 7 1 Identify control materials to be used Siemens Method Topics Intended Use Intended Use Principles of the Procedure Intended Use Sample Handling Limitations of the Procedure Intended Use Sample Handling Sample Handling Reagents Reagents Storage and Stability Quality Control Storage and Stability Not applicable Calibration Quality Control Regulatory Information CLSI Approved Guideline M29 A3 5 1 7 2 Instructions for preparing and handling control materials 5 1 7 3 Control frequency 5 1 7 4 Description of control tolerance limits 5 1 7 5 Corrective actions to be taken when limits are exceeded 5 1 7 6 How QC data are recorded and stored 5 1 7 7 If no controls are available list alternatives 5 1 8 Procedure Stepwise 5 1 8 1 Detailed stepwise instructions 5 1 8 2 Centrifugation requirements 5 1 8 3 Specify special glassware 5 1 8 4 Specify the following for photometric measurements Type of instrument Wavelength Cuvette size Solution used as a blank Linearity How the raw data are read Allowable time intervals Stability of fina
327. ndividual Laboratory Practice Sample Handling Limitations Sample Handling Limitations Procedure Sample Handling Limitations Performance Characteristics According to Individual Laboratory Practice Performance Characteristics Interfering Substances Performance Characteristics Bibliography Regulatory Information CLSI Approved Guideline M29 A3 Siemens Method Topics 5 1 13 2 Manufacturer product To obtain the version of literature the online documentation click Options on the menu bar of the help window and then click Version 5 1 13 3 Textbooks 5 1 13 4 Standard Publications 5 1 13 5 Written personal communications 5 1 13 6 Research including supporting data for validation of methods CBC Method Intended Use The ADVIA 2120 21201 Hematology System Complete Blood Count CBC method is intended to quantitatively measure the following hematological parameters White Blood Cell count WBC Red Blood Cell count RBC Hemoglobin concentration HGB Hematocrit HCT Mean Corpuscular Volume MCV Mean Corpuscular Hemoglobin MCH Mean Corpuscular Hemoglobin Concentration MCHC Corpuscular Hemoglobin Concentration Mean CHCM Cellular Hemoglobin Content CH Red Cell Volume Distribution Width RDW Hemoglobin Concentration Distribution Width HDW Platelet Count PLT Mean Platelet Volume MPV Regulatory Information 9 21 9 22 Principles of the Procedure WBC Count Th
328. ne the SD in the Control Dictionary Selected Printer Not Available Result Report for SID The printer is not responding to a print request Corrective Action Check that the printer is powered on and has paper Refer to the Message Log for details Selector Valve Error Potential software communication error or a hardware failure associated with the selector valve assembly Possible Cause Corrective Action 1 Hardware Reset the analyzer by selecting Utilities Exerciser failure Indicators Analyzer Reset b After about 1 minute if the status line does not display Status Line messages 7 89 7 90 Ready to Run and the green ready to aspirate light is still off follow these steps to exit the ADVIA 2120 21201 software turn off the analyzer and then restart i Select Shut Down ADVIA at the Log On Off window ii Select Off at the analyzer touchpad iii Select CTRL ALT DELETE and log back onto the system to restart the software iv Restart the analyzer by selecting On at the analyzer touchpad 2 Faulty power Call Siemens Service for assistance supply fuse cable selector valve assembly UFC Scrambler Board or Can Bus Scrambler Board Selector Valve Timeout The selector valve failed to return to the home position within the expected time interval Possible Cause 1 Hardware failure 2 Faulty power supply fuse cable selector valve assembly UFC Corrective Action a Reset analyzer
329. ng collar A WARNING To avoid personal injury and exposure to a potential biohazard you must cover the needle with the red needle cover immediately after you remove the centering collar Be careful not to bend the needle as you slip the cover over it 1 Turn off the analyzer 2 Remove the centering collar from the Autosampler or Manual closed tube sampler see specific procedures below 3 Place the centering collar in a beaker filled with 25 solution of household bleach and water and let it soak for five minutes 4 Using a cotton swab scrub off any remaining residue then rinse with water 5 Usea stylet or a piece of thin wire to clean the three nipples and the center bore on the autosampler centering collar or the nipple and center bore on the manual closed tube sampler centering collar Maintaining the Analyzer 6 Attach a piece of 0 030 inch ID tubing to a syringe then flush each port on the autosampler collar or the waste port on the manual closed tube sampler collar with water IMPORTANT To prevent autosampler centering collar lock ups apply Parker Super O lube or equivalent lubricant to the barrel part 1 of the centering collar Do not get lubricant near the needle port or the needle base 2 NOTE The dual Autosampler has two centering collars one for analyzer sampling and one for optional Autoslide sampling 2 Both Centering collars use the same cleaning method 7 Reconnect all the tubes exce
330. nimal body fluids should be handled before and after cleaning as if capable of transmitting infectious diseases Wear facial protection gloves and protective clothing The operator should follow the recommendations to prevent the transmission of infectious agents in health care settings as recommended for potentially infectious specimens in Protection of Laboratory Workers from Infectious Disease Transmitted by Blood Body Fluids and Tissue 2nd edition Approved Guideline 1997 Document M29 A National Committee for Clinical Laboratory Standards NCCLS This document contains complete information on user protection and it can be used as reference material for instructions on laboratory safety 1 Remove the sample probe See page 5 37 for instructions 2 Waitfor about two minutes until the vacuum is released from the wash block Gently move the push to aspirate paddle and wash block assembly down approximately 1 inch 25 4 mm 3 Support the push to aspirate paddle with one hand With the fingers of your other hand grab the top and bottom of the wash block and gently push down on the block until it slides down about inch 6 5 mm Align the tabs on the wash block with the openings on the paddle assembly Remove the block by gently pulling it straight out Troubleshooting the Analyzer 5 47 5 48 Mark the tubes with tape the top line is rinse and the bottom line is vacuum then remove the lines Be careful not to allow the tu
331. ns Status Line messages Corrective Action The stop counter is automatically reset after reagents are replenished and the Reagent Installation window is updated Go to Logs Reagent Log Reagent Installation Select Start Stop to continue the run BASO Reagent Expired Present date is beyond the BASO reagent expiration date as determined by encoded reagent container barcode label or as calculated from installation date and open container stability Corrective Action Replenish expired reagents and update the Reagent Installation window Go to Logs Reagent Log Reagent Installation BASO Reagent Low Alarm The number of consecutive occurrences of this condition has met the criterion specified for an alarm message indicating that the reagent level is low The specified alarm criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria Reagent Conditions Corrective Action The alarm counter is automatically reset after reagents are replenished and the Reagent Installation window is updated Go to Logs Reagent Log Reagent Installation BASO Saturation Alarm The number of consecutive occurrences of this condition has met the criterion specified for an alarm message The specified alarm criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Alarm Criteria is automatically reset BASO Saturation Stop The number of consecutive occur
332. nsors Doing so may result in operator injuries Do not open the Autoslide doors or covers during instrument operation This causes the instrument to stop operation and cancel any running slides METHANOL SAFETY bp Toxic Toxic danger of very serious irreversible effects through inhalation ws in contact with skin and if swallowed Keep container tightly closed Avoid contact with skin Wear suitable protective clothing and gloves In case of accident or if you feel unwell seek medical advice immediately show the label where possible ADVIA Autoslide Slide Maker Stainer 10 7 10 8 Highly Flammable Highly flammable Keep away from sources of ignition No smoking ADVIA Autoslide Slide Maker Stainer Theory of Operation 1 Slide dispenser 2 Drop needle 3 Slide carrier 4 Sampling syringes 5 Smearer ADVIA Autoslide Slide Maker Stainer 6 Printer 7 Stainer assembly 8 Reagent syringes 9 Rack out queue 10 Verticalizer 11 Rack transfer 12 Slide transfer grabber 13 Manual inlet 14 Rack loader 10 9 1 drop needle dispenses a drop of the sample a slide It dispenses the rest of the sample into the drop needle rinse bath and then is rinsed with rinse 2 The smearing assembly wedge and smearing ribbon create the smear using the surface tension of the blood The wedge is positioned on the slide before being brought into contact with the blood waiting for the blood to migrate along th
333. nspection scope must be available for this procedure Do not remove the flowcells unless you are trained in how to align and focus them 1 Bring the analyzer to the Ready to Run mode 2 At the Operations menu select Startup select Refresh and verify the background count Check the flowcell connections for leaks Check the focus and alignment of the flowcell Check the gains Run a whole blood primer then run controls to verify analyzer performance Soa or PY If the control results are acceptable to the laboratory no additional action is required and normal operation can be resumed Backflushing the Perox Flowcell and Shuttle and Reaction Chambers Materials required e Flowcell cleaning kit PN 113 B711 01 e EZ KLEENBeaker e Deionized water Analyzer mode Ready to Run BIOHAZARD All products or objects that come in contact with human or animal body fluids should be handled before and after cleaning as if capable of transmitting infectious diseases Wear facial protection gloves and protective clothing Troubleshooting the Analyzer 5 21 The operator should follow the recommendations to prevent the transmission of infectious agents in health care settings as recommended for potentially infectious specimens in Protection of Laboratory Workers from Infectious Disease Transmitted by Blood Body Fluids and Tissue 2nd edition Approved Guideline 1997 Document M29 A National Committee for Clinical Laboratory St
334. nt bias when comparing to the ADVIA 2120 21201 Hematology system method In this event use the calibration procedure to obtain agreement with the other method Calibration procedure should be performed e Upon installation of the system e If there is a significant shift in control values after the replacement of a critical hardware component or reagent lot after checking gains e Anytime control results and or moving averages are out of range and it has been verified that the out of control condition is instrument related Regulatory Information 9 57 9 58 Sample Handling Sample Collection Collect whole blood in an evacuated blood collection tube containing EDTA as an anticoagulant Blood samples should be refrigerated at a temperature from 2 C to 8 C if they will not be analyzed within eight 8 hours of phlebotomy If a specimen has been refrigerated allow it to equilibrate slowly to room temperature 15 C to 30 C before mixing Sample Dilution Dilution of whole blood specimens for RETIC analysis is not recommended Sample Stability The effect of the aging of blood was studied over a 72 hour period on the ADVIA 120 Hematology System Two whole blood specimens drawn from 15 normal apparently healthy donors were assayed shortly after phlebotomy and then again at intervals of 8 24 36 48 56 and 72 hours One of the whole blood specimens from each pair was stored at room temperature while the corresponding spe
335. ntal regulations 4 Replace the cap then snap the bottle in place 5 Make sure that the tubes are not pinched and have not slipped through the cap The ends of the tubes should be at least 1 5 inches from the bottom of the bottle Adjust if necessary Checking the Reagents 1 Use the Startup tab or the Reagent Log tab to check the supply of all reagents except ADVIA 2120 21201 DEFOAMER 2 Visually check the supply of ADVIA 2120 21201 DEFOAMER 3 If you need to replace reagents use the Reagent Log tab Obtaining the Background Counts Run a background count cycle to obtain a BASO WBC background count a platelet background count and an HGB Trans 1 At the Operations menu select Startup 2 Select Refresh Daily Routine 3 The background results are color coded m Green Within range Red Out of range If any result is out of range select Refresh at the Startup tab to run another background count cycle If any result is still unacceptable perform a system wash Processing the Samples Daily Routine Creating the Workorders The Order Entry window allows you to create and manage workorders at the analyzer You can also create workorders at the host computer Creating Workorders by SID 1 2 3 4 5 6 At the Access menu select SID sample ID number In the SID box enter the sample ID then select Enter or select OK Optional Enter sample and patient information Use the Tab key to m
336. nternal Dell Business Audio Speaker Microsoft Windows 2000 Professional Service Pack 3 NTFS 2 x PCI for the modem and ethernet cards Must be configurable to meet limitations below Power management Suspend Mode S3 AC Power Recovery Off Low Power Mode Disabled Remote Wake Up Off Small Desktop 1 x 3 5 Floppy Bay 1 x 5 25 Floppy 1 108 x 390 x 431mm 210W Model HP U2106F3 Rev H01 Physical Specifications Electrical Power Requirements Temperature Requirements Relative Humidity Heat Generation Audible Noise Level Installation Category Pollution Degree Voltage selectable for single phase 100 VAC 6 AMPS 240 VAC 3 AMPS Frequency 50 60Hz Operating 18 C to 35 C Storage 45 C to 70 C Operating 15 80 non condensing Less than 3000 BTU less than 880 W 65 decibels 2 Welcome to the ADVIA 2120 2120i Hematology System Waste Disposal Azide free reagents drain into waste container with automatic level sensor shutoff Waste per CBC diff retic cycle including rinse 23 mL The ADVIA 2120 2120i Hematology System is for indoor use only Operation of the instrument at altitudes of over 2000 meters 6000 feet is not recommended Analytical Module with Autosampler Analytical Module without including reagents Autosampler including reagents Weight 191 9 kg 422 5 lbs Weight 161 9 kg 357 5 lbs Height 85 cm 33 4 in Height 85 cm 33 4 in Width 141 cm 55 5 in Width 81 cm
337. o not stain and they are the negative cell population Immature Reticulocyte Fraction Immature Reticulocyte Fraction IRF is a descriptive term recommended in NCCLS Document H44 A Methods for Reticulocyte Counting Flow Cytometry and Supravital Dyes Approved Guideline to replace a previously used term Reticulocyte Maturation Index RMI Two IRF parameters are calculated and IRF H M RETIC Rate Histogram The RETIC Rate histogram shows the uniformity of the cell counting rate The rate histogram data consists of 50 points one taken every 200 milliseconds Each point represents the number of valid cells counted during the last 200 milliseconds 8 59 8 60 RETIC Abs Flatness Histogram The RETIC Abs Flatness histogram data consists of 50 points one taken every 200 milliseconds Each point represents the mean absorption for the last 200 milliseconds This histogram provides a visual indication of the absorption signal flatness to monitor the laser performance Laser oscillation can cause an erratic presentation RETIC Abs Histogram The RETIC Abs histogram represents the distribution of mature RBCs and reticulocytes according to their corrected absorption values Absorption correction compensates for drift in the absorption channel optics and for scattered light that is not collected RETIC Volume Histogram The RETIC Volume histogram represents the overlaid distributions of mature RBC
338. o perform a SID RESET 4 If desired select the Q C Close Out check box to transfer the daily QC file into the Cumulative QC file Use the list box to select close out for all controls or a specific control 5 Ifdesired select the MOV AVG Close Out check box to obtain a cumulative data point from moving average control statistics with a date earlier than the date in the Up to box Daily Routine Daily Routine If desired select the check boxes for any files you want to back up Verify the destination for the Q C file backup 7 Select the Purge Database check box 8 Note the values in Total Samples and To be purged fields In the To be purged field enter the number of records if any you want deleted from the All Complete file 9 Select OK to confirm and start 10 If you requested a backup in step 6 you will be asked to insert a formatted disk into the disk drive Requirements for backup disks are as follows e Programs Format one or more disks with the label PRG e Dictionaries Format one disk with the label DICT e Cumulative Quality Control Format one disk no label is necessary e Database Four formatted disks are required for 2000 All Complete sample records The database disks do not need to be labeled The system will automatically label the disk s during the backup procedure When several disks are required the internal label entered during formatting for each disk must be the same To visually identif
339. occurs The specified stop criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Stop Criteria is reset when the Start Stop button is selected Length of Range Field Too Long in REPORT PAR File The ranges have been incorrectly defined in the Report par file Corrective Action Use the Format window to correct the problem Macrocytosis Alarm The number of consecutive occurrences of this condition has met the criterion specified for an alarm message The specified alarm criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Alarm Criteria is automatically reset Macrocytosis Stop The number of consecutive occurrences of this condition has met the criterion specified for a stop message The autosampler halts at the same time the stop message occurs The specified stop criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Stop Criteria is reset when the Start Stop button is selected Manual Sample ID Auto Increment Off Auto increment feature has been turned off Use Operations Manual Sample ID The sample ID for manually aspirated samples will not automatically increment by one The sample ID must be entered by keyboard barcode reader or workorder Manual Sample ID Auto Increment On Auto increment feature has been selected Use Operat
340. ocedure Cleaning the Shear Valve e Go to Step 1 to take the shear valve apart e Go to Step to reassemble the shear valve with the new part To check analyzer performance e At the Operations menu select the Startup tab and verify background counts e Runa whole blood primer Runcontrols If controls do not recover calibrate the affected channel Troubleshooting the Analyzer Replacing the fuses IMPORTANT All fuses must be replaced with same rated fuses Materials required Flat head screwdriver Fuse ratings and part numbers FUSE APPLICATION FUSE DEVICE NO PROTECTED TYPE Fl AC Input L1 3 AB F2 AC Input L2 3 AB F3 Computer Monitor at 20mm J24 and J25 F4 Power Supply PS1 5V 20mm F5 Power Supply PS4 45V 20mm Perox Lamp and 15V F6 Power Supply PS2 20mm 24 F7 Power Supply PS3 5V 20mm and 12 Troubleshooting the Analyzer FUSE RATINGS 220 V 100 V 230 V 120 V SYSTEMS 240 V SYSTEMS 15 00A T 250V PN625 0073 03 15 00A T 250V PN625 0073 03 6 30A T 250V PN 625 0127 11 0 50A T 250V PN625 0127 09 2 00 A T 250V PN 625 0127 04 4 00A T 250V PN 625 0127 05 3 15A T 250V PN 625 0127 10 8 00A T 250V PN625 0073 02 8 00A T 250V PN625 0073 02 3 15A T 250V PN 625 0127 10 0 25A T 250V PN 625 0127 07 1 00A T 250V PN 625 0144 03 2 00A T 250V PN 625 0127 04 1 60A T 250V PN 625 0127 06 5 31 5 32
341. ocyte Count PHA Cells BASO LYMPH LYMPH 100 x WBC MONO 100 x Monocyte Count PHA Cells MONO MONO 100 x WBC EOS 100 x Eosinophil Count PHA Cells EOS EOS 100 x WBC LUC 100 x LUC Count PHA Cells LUC LUC 100 x WBC The system uses data from the perox channel and the baso channel to derive the Nucleated Red Blood Cell NRBC count 7NRBC and NRBC If nRBCs are present the system corrects the WBC results to account for them The system can also display Peroxidase channel and Basophil Lobularity channel WBC counts and the associated differential counts that have not been corrected for NRBCs even if NRBC counts are reported The uncorrected counts are designated by a lower case Methods Methods Additional Parameters The following parameters are for research or laboratory use only and are not for patient reporting Parameter Clumps Count Valley Count Lymph Mode MPXI NEUT X NEUT Y Noise Lymph Valley Perox d D PEROX Dead Time PEROX Noise PEROX Saturation PEROX Flatness Parameter Key WBCP Explanation 100 x HPX PHA Cells Number of events in the Platelet Clumps area of the PEROX cytogram Number of events in the NRBC area of the PEROX cytogram Mode channel of the Lymphocyte cluster X Mean of Sample Neut Expected staining index Expected staining index 100 Mean X channel for neutrophil cluster Mean Y channel
342. od cells are lysed using ADVIA 2120 21201 1 reagent and the high temperature in the reaction chamber Step 2 White blood cells are fixed using ADVIA 2120 21201 PEROX 1 reagent Step 3 White blood cells are stained using ADVIA 2120 21201 2 reagent and ADVIA 2120 2120 3 reagent White blood cells are identified based on size and different intensity of peroxidase reaction staining Neutrophils eosinophils and monocytes are stained based on their levels of peroxidase activity Since lymphocytes basophils and large unstained cells contain no peroxidase these cell types remain unstained Perox Temperature Control Temperature control is critical to lysing the red blood cells The perox reaction chamber temperature which is automatically monitored by the analyzer must be between 58 C and 72 1 C If you want to check the perox reaction chamber temperature use the Analyzer Status tab If you need to adjust the perox reaction chamber temperature 1 Atthe Special Procedures menu select Adjust Lamp Temp 2 Select Perox Temperature ADVIA 2120 2120i PEROX 1 NOTE For more detailed information on the contents of ADVIA 2120 21201 PEROX 1 reagent please see Chapter 8 ADVIA 2120 2120i PEROX 1 is the first reagent added to whole blood sample in the heated peroxidase reaction chamber Its function is to lyse the red blood cells and fix the white blood cells Surfactants sodium dodecyl sulfat
343. odel of instrument Design Changes and Retrofitting of Instruments Siemens reserves the right to change the design or construction of specific models of instruments at any time without incurring any obligation to make such changes available to individual customers or instruments If Siemens notifies customers of a change that improves the performance or reliability of their instrument and requests to retrofit that instrument the customer must agree to allow Siemens or an authorized distributor at Siemens expense to retrofit components or make design changes which does not adversely affect the instrument s performance characteristics A 3 Key Operator Designation Each customer designates a key operator who is available to Siemens representatives to describe instrument malfunctions by telephone and or to perform simple adjustments and corrections as requested If a key operator is not designated or is unavailable when the customer requests service the delivery of service may be delayed OSHA Requirements US only When service is required at a customer location the customer must provide the Siemens representative with adequate facilities that comply with the regulations of the Secretary of Labor under the Occupational Safety and Health Act OSHA of 1970 as amended Warranty and Service Exclusions A 4 The following exclusions are in addition to any exclusions provided for in any written warranty or service agreement
344. odified Wright Stain e Methanol gt 99 e Polychrome methylene blue eosin stain 0 3 Toxic Toxic danger of very serious irreversible effects through inhalation in contact with skin and if swallowed Keep container tightly closed Avoid contact with skin Wear suitable protective clothing and R39 23 24 25 gloves In case of accident or if you feel unwell seek medical advice S7 24 immediately show the label where possible Contains methanol 36 37 S45 ADVIA Autoslide Slide Maker Stainer 10 29 Highly Flammable Highly flammable Keep away from sources of ignition No smoking Contains methanol Modified Wright Buffer e Phosphate buffer e Surfactant Methanol e Methyl Alcohol gt 99 8 96 Toxic Toxic danger of very serious irreversible effects through inhalation in contact with skin and if swallowed Keep container tightly closed Avoid contact with skin Wear suitable protective clothing and R39 23 24 25 gloves In case of accident or if you feel unwell seek medical advice S7 S24 immediately show the label where possible Contains methanol 536 37 S45 10 30 ADVIA Autoslide Slide Maker Stainer Highly Flammable Highly flammable Keep away from sources of ignition No smoking Contains methanol Reagent Storage and Stability Store Stain Buffer and Methanol tightly closed between 15 C and 30 C Cover open reagent bottles with Parafilm or equivalent to avoid excessive evaporation When unop
345. ol program and procedures Control materials should be assayed e At the beginning of each shift or at some other interval chosen by the laboratory e After a reagent lot number change e After replacement of any part or component of the analytical module that may affect analytical performance As an option laboratories may run a retained patient sample periodically to monitor performance trends Results The system automatically performs all calculations necessary for obtaining final results Through the use of complex flagging algorithms laboratory personnel are alerted to suspected abnormal conditions These conditions are indicated by the appropriate flag such as and or color highlighting Whenever flags occur the user should review the results and take appropriate action Limitations of the Procedure The limitations of the procedure are as listed 1 Certain abnormal specimens such as those from hemodialysis patients patient specimens with nucleated RBCs particularly neonates as well as specimens exhibiting platelet clumping or incomplete lysis of RBCs may interfere with white cell differential 2 Circulating micromegakaryocytes may be counted as white blood cells 3 Incomplete RBC lysis in the Peroxidase channel may be observed in specimens with elevated serum urea nitrogen BUN gt 75 mg dL 4 Interference with the performance of the Peroxidase channel may be noted in specimens obtained from pati
346. ollar Retract Denied To prevent the collision of autosampler components the system did not execute the command to retract the autosampler centering collar Autosampler Critical Error Reset Autosampler Critical autosampler error A reset is required Corrective Action 1 Select Off at the analyzer touchpad 2 Wait about 1 minute and select On to restart the analyzer 3 If the problem persists call Siemens Service for assistance Autosampler Diagnostic Mode Not In Effect The analyzer sent a diagnostic command to the autosampler while the autosampler was in operating mode Corrective Action 1 Open the Autosampler window of the Exerciser tab 2 Select Enter Diagnostic Mode Autosampler Eject Rack Failed The autosampler failed to respond to the eject rack command and is not clearing racks from the mixer and input and output shuttles Possible Cause Corrective Action 1 Command At the analyzer touchpad select Off from analytical b Wait about minute and select On to restart the module not analyzer received by autosampler Ifthe problem persists call Siemens Service for assistance 2 All See la b c communication Status Line messages 7 21 7 22 between the autosampler and the analyzer may be down Autosampler See la b operation may be down Autosampler Error Reason Unknown Unknown autosampler software error Corrective Action 1 At the analyzer touchpad select Off 2 Wait about 1 min
347. ols do not recover calibrate the affected channel Cleaning the Air Circulation Filter Time 5 minutes Location of the air filter 1 To clean the air filter 1 Remove the filter by sliding it to the right out of its frame Remove excess dust or lint from the filter by tapping it against a clean hard surface or by vacuuming Flush the filter with a strong stream of water first on one surface then on the other surface If the filter remains dirty swish it around in a container filled with warm water and mild detergent Rinse the filter with clean water then allow it to air dry Inspect the Perox Cap Vent Hole for Buildup Maintaining the Analyzer Disconnect the overflow tube 1 from the perox vent Remove the cap 2 Look at the inside of the cap and look through the vent opening Make sure that the cap and the vent are clean dry and free of buildup 4 19 4 If necessary clean the cap and the vent opening Use the drill bit included in the flowcell cleaning kit PN 113 B711 01 to clean blockages in the vent opening 5 Replace the cap and reconnect the overflow tube Cleaning the Autosampler Aspirate Assembly 4 20 Clean the autosampler aspirate assembly if there is a salt buildup BIOHAZARD All products or objects that come in contact with human or animal body fluids should be handled before and after cleaning as if capable of transmitting infectious diseases Wear facial protectio
348. olume range 0 fL to 60 fL Integrated Analysis The 2 Dimensional platelet analysis 2D PLT method is based on the integrated analysis of red blood cell and platelet measurements The PLT Scatter cytogram is formed by pairing light scatter signals acquired at low angle high gain and at high angle high gain that are converted into volume and refractive index values The PLT Scatter cytogram displays cells with volumes of 0 fL to 30 fL Cell identification and counts for cells with volumes greater than 30 fL is done using the RBC Scatter cytogram Integrated analysis is used todistinguish platelets large platelets red blood cells RBC fragments and RBC ghosts This example illustrates how large platelets are counted e Large platelets are identified on the PLT Scatter cytogram based on their refractive index values 1 35 to 1 40 and a volume greater than 20 fL Methods Large platelets are also identified on the RBC Scatter cytogram area 3 below based on their refractive index values 1 35 to 1 40 and a volume less than 60 fL The Platelet VOL histogram contains platelets and large platelets with volumes up to 60 fL B x axis A high angle 5 to 15 light scatter y axis B low angle 2 to 3 light scatter e Area covered by the PLT Scatter Cytogram RBC fragments Large platelets RBCs e RBC ghosts Calculating RBC Parameters Reported Parameters Parameter Explanation RBC Number of Re
349. omplete biohazard statement refer to section on Autoslide Safety Information and Warnings When the stainer access door is opened during Autoslide operation all Autoslide actions stop Autoslide Rear Panel Orns eur Caution Attention Atenci n Cuidado cron Gsm Asu sm 250V 2 0A T Key Oms Om Onn Li Rinse Buffer Water Water Sensor Stain Waste Sensor STN sm sm Methanol Stain 1 Stain 2 Stain Waste Fan AN CAUTION Do not obstruct fan 10 4 ADVIA Autoslide Slide Maker Stainer Main power switch and power supply connection AN CAUTION The power switch and input voltage supply connection should always be accessible When positioning the system for operational use leave the required amount of space for easy accessibility to these items Installation connection and disconnection of the ADVIA Autoslide Slide Maker Stainer must be performed by authorized personnel only For the main supply grounding is required Check that earth wall plug is correctly connected to the laboratory grounding system If there is no such system a ground stake should be used Use only main supply cable delivered with the instrument or cable with same characteristics e Europ cord type HOSVV F e USA cord type SVT AWG 18 3 Main supply voltage fluctuations not to exceed 10 of the nominal voltage Fluidic and sensor connections BIOHAZARD Wear personal protective e
350. onstant awareness of the hazards and warnings associated with all reagents Where necessary appropriate safety equipment should be used e g eye protection gloves lab coats Users should follow the handling and safety precautions specified in the Material Safety Data Sheets available from Siemens Reagent and Calibrator Preparation Reagents and calibrators are ready to use and require no preparation Regulatory Information System Method Information Storage and Stability Reagent and calibrator storage and expiration dates are printed on the product label When stored unopened these products are stable through the last day of the month stated in the expiration date unless stated otherwise System Method Information Sample Handling Whole blood specimens whose parameter values exceed the analytical range may be diluted with autologous plasma or isotonic saline and reassayed unless stated otherwise in the method specific information System Method Information Materials Required but not Provided This topic lists the additional materials other than the reagents that are required to perform the methods System Method Information Procedure For general operating instructions refer to the Daily Routine System Method Information Quality Control This section specifies recommended quality control material and quality control frequency for the individual method In general Siemens recommends that ADVIA 2120 2120i Hematology S
351. ontainer barcode label or as calculated from installation date and open container stability Corrective Action Replenish expired reagents and update the Reagent Installation window Go to Logs Reagent Log Reagent Installation RBC Reagent Low Alarm The number of consecutive occurrences of this condition has met the criterion specified for an alarm message indicating that the reagent level is low The specified alarm criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria Reagent Conditions Status Line messages 7 81 Corrective Action The alarm counter is automatically reset after reagents are replenished and the Reagent Installation window is updated Go to Logs Reagent Log Reagent Installation RBC Sample Pump Error Reset Required RBC sample syringe pump not in home position failed to respond or a transmission error occurred Possible Cause 1 RBC sample syringe pump not moving or not in home position 2 RBC sample syringe incorrectly assembled 3 Faulty power supply fuse cable pump assembly Can Bus Scrambler Board or Dual Servo Pump Control Board Corrective Action a b Reset the analyzer by selecting Utilities Exerciser Indicators Analyzer Reset After about 1 minute if the status line does not display Ready to Run and the green ready to aspirate light is still off follow these steps to exit the ADVIA 2120 21201 software turn off the analyzer a
352. op Criteria The counter associated with the Alarm Criteria is automatically reset WBC Substitution Stop The number of consecutive occurrences of this condition has autosampler halts at the same time the stop message occurs The specified stop criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Stop Criteria is reset when the Start Stop button is selected Status Line messages Wrong Sample Type for Test Number xx The type defined in the Test Dictionary for this test is not consistent with the sample type in process Corrective Action Check the Test Dictionary and the pending sample for the proper sample type Wrong Test Group Defined A test has been defined in several test groups or it has been defined in a test group but not in the Test Order Table The Data Manager cannot manage the defined test groups Corrective Action Use the Customer Parameters window to correct the test group definition Status Line messages 7 99 7 100 Status Line messages Methods BASOPHIL LOBULARITY METHOD 0 cssscssssssssscsssccssccsssccssescsscsssssssssssees 3 CYTOCHEMICAL 8 0 22142066000000000000000000000000000 00 3 BASOPHIL LOBULARITY TEMPERATURE 3 2120 21201 BASO REAGENT cccsesccccececsesssaeeecececsessaececccecsensaseeeececeenenaeea 3
353. opriate action in accordance with established standard operating procedures Morphology flags appear on the Run Screen and the Review Edit tab The following table identifies the morphology flags and that can be triggered for each test selectivity The two letter codes in parentheses appear on the Run Screen Triggering Criteria CBC CBC CBC DIFF CBC RETIC DIFF RETIC RETIC RDW gt 16 v 4 Y 4 96 LUC gt 4 5 and 4 LUC gt BLAST 1 5 1 5 5 1 5 to Y v 5 0 and LUC gt 4 5 or 2 BLASTS gt 5 0 WBCB or 3 BASO BASO Susp 5 Sat gt 10 HDW gt 3 4 g dL v v HYPER gt 4 HYPO 4 Y v v NEUT EOS gt 5 0 6 3 Flag LPLT LS MACRO MICRO MPO D MO NRBC PLT CLM NW RBCF RBCG 6 4 Triggering Criteria CBC CBC DIFF CBC RETIC DIFF RETIC RETIC LPLT gt 10 PLT Y Y Y Y BASO d D 0 15 and Y gt 30 gt 2 5 Y Y v Y 7o MICRO gt 2 5 v Y Y Y PMN NEUT EOS 25 no NRBC flag and a valid MN PMN valley d D gt 0 15 1 WBCu gt to 3000 cells Y Y uL and nRBC 2 096 nRBC 100WBC Or 2 nRBC 200 cells uL Clumps Count 150 Y RBCF 100 000 cells uL Y v v RBCG gt 100 000 cells uL Y Y A Anisocytosis ANISO Definition The Anisocytosis flag is triggered if variation in RBC volume RDW is equal to or greater than 16 Th
354. or message on the status line Turn off the system wait 60 seconds and then restart it If the error recurs call your Service Representative c The system automatically opens the Startup tab Review the status of the Startup process IMPORTANT In cases when the analyzer is turned off and restarted too quickly the compressor may not start up causing the system initialization to fail This is due to residual vacuum in the waste container The operator must manually vent the container ire To manually vent either container manual or autowaste disconnect the waste container vacuum line 1 wait for the vacuum to dissipate and then reconnect the line Turning the System On Off 2 3 Turning the system off IMPORTANT To ensure good system performance turn the computer off at least once a week You must follow the proper procedure when shutting down the ADVIA 2120 21201 Hematology System Failure to do so can result in corruption of the database Turning the system off In an Emergency 1 Select Off at the analyzer touchpad 2 Ifemergency conditions permit select Shut Down ADVIA at the Log On Off tab 3 Setthe main power switch to Off NOTE When you turn off the analyzer in an emergency it is unable to drain some lines as it would normally As a result when you restart the system you should perform a System Wash using the Hydraulic Functions tab on the Utilities menu before running sample
355. or an alarm message The specified alarm criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Alarm Criteria is automatically reset No Cell Cluster Fit on PEROX Stop The number of consecutive occurrences of this condition has met the criterion specified for a stop message The autosampler halts at the same time the stop message occurs The specified stop criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Stop Criteria is reset when the Start Stop button is selected No Data Available in Result Message The Data Manager cannot recognize the result types received from the analyzer Corrective Action Call Siemens Service for assistance Status Line messages 7 61 7 62 No Graphic Result Data in Result Message The Data Manager cannot compress graphic results before storing them in the database Corrective Action Call Siemens Service for assistance No Help Available for this Message There is no Help available for this message at this time If you cannot find sufficient information in the Operator s Guide contact your Siemens Representative for assistance No Numerical Result in Result Message The Data Manager cannot convert CBC DIFF or Retics results into numerical or comment results Corrective Action Call Siemens Service for assistance No PEROX Noise Lymph Valley Alarm The number o
356. or occurs when there is no value defined for the FSE parameter Calculs_PatientQC_Formula This parameter determines the formula used to calculate the moving average To define the parameter contact your local Siemens technical support provider The possible settings for the parameter are 0 parameter not active 1 Bull s Algorithm Status Line messages 7 67 7 68 2 arithmetic mean Patient QC Formula Not Defined Parameterization Calcul This error occurs when there is no value defined for the FSE parameter Calculs_PatientQC_Formula This parameter determines the formula used to calculate the moving average To define the parameter contact your Siemens Field Service Representative The possible settings for the parameter are 0 parameter not active 1 Bull s Algorithm 2 arithmetic mean Patient Result Database Is Full The patient result database has reached maximum capacity causing the autosampler to stop and transition the system state to Aspiration Paused Corrective Action Increase available patient result database space by deleting data from the sample results file Use Customize System Setup Tools Modify End of Day IMPORTANT Deleting files permanently erases data If you need an electronic copy of the data back up the files before deleting Patient Result Database Is Nearly Full The patient result database has reached the level specified as the warning level causing the autosampler to
357. ormance specification for carryover is lt 1 for all parameters Carryover was evaluated on the ADVIA 120 Hematology System by the aspiration of a high pool prepared for linearity testing followed by 3 aspirations of cell free plasma Percent carryover was calculated as Carryover L1 L3 H x 100 Li the count for the first aspiration of cell free plasma L3 the count for the third aspiration of cell free plasma H the count from the high pool The following results were obtained Parameter WBC RBC HGB Regulatory Information Observed Carryover 0 4 0 2 0 2 9 31 9 32 PLT 0 1 Performance Characteristics Analytical Range The analytical range for the ADVIA 2120 2120i Hematology System was established by making serial dilutions of samples specially prepared to have high analyte values Multiple assays of the specially prepared pools were performed on the system Parameter WBC 103 uL RBC 1091 HGB g dL PLT 103 01 Range Evaluated 0 02 to 21 83 20 48 to 409 55 0 0 to 2 65 2 65 to 6 76 0 0 to 8 6 8 6 to 22 5 5 to 208 205 to 3983 Maximum Observed Deviation 0 46 x 103 uL 41 0 03 x 10911 1 1 0 2 g dL 2 5 10 x 103 uL 4 9 Regulatory Information CSF Method Intended Use ADVIA 2120 21201 Hematology Cerebrospinal Fluid CSF assay is intended for in vitro diagnostic use in the quantitative determination of blood cells in cerebrospinal f
358. orpuscular Hemoglobin MCHC Mean Corpuscular Hemoglobin Concentration Calculating the HGB Result Using CHCM The Corpuscular Hemoglobin Concentration Mean CHCM and Mean Corpuscular Hemoglobin Concentration MCHC both provide a measurement of the average corpuscular hemoglobin concentration in the sample The CHCM is a directly measured parameter based on a cell by cell analysis while the MCHC is a calculated parameter based on the HGB MCV and RBC results If they differ by more than 1 9 g dL a Comparison Error MCHC CHCM CHCMCE sample system flag alerts operators to a condition that could be affecting one or more of the three results RBC MCV or HGB used to calculate MCHC For example severe lipemia is a known interference that can falsely elevate a HGB result obtained from the colorimetric hemoglobin method When the hemoglobin is falsely increased the MCHC is also falsely increased Using CHCM to calculate HGB avoids this interference since CHCM is directly measured and is virtually unaffected by lipemia To calculate HGB replace MCHC with CHCM as follows MCHC HGB RBC x MCV x 1000 HGB MCHC x RBC x MCV 1000 Calculated HGB CHCM x RBC x MCV 1000 or CHCM x Het 100 The Measured HGB and Calculated HGB values are displayed on the HGB panel of the Run Screen Methods Peroxidase Method Methods Cytochemical Reactions The peroxidase cytochemical reactions consist of three steps Step 1 Red blo
359. osampler halts at the same time the stop message occurs The specified stop criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Stop Criteria is reset when the Start Stop button is selected Platelet Noise Alarm The number of consecutive occurrences of this condition has met the criterion specified for an alarm message The specified alarm criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Alarm Criteria is automatically reset Platelet Noise Stop The number of consecutive occurrences of this condition has met the criterion specified for a stop message The autosampler halts at the same time the stop message occurs The specified stop criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Stop Criteria is reset when the Start Stop button is selected Possible Blasts or Abnormal Cells Alarm The number of consecutive occurrences of this condition has met the criterion specified for an alarm message The specified alarm criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Alarm Criteria is automatically reset Status Line messages 7 75 7 76 Possible Blasts or Abnormal Cells Stop The number of consecutive occurrences of this condition has met the criterion specified for a
360. osampler halts at the same time the stop message occurs The specified stop criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Stop Criteria is reset when the Start Stop button is selected Status Line messages HGB Irregular Flow Rate Alarm The number of consecutive occurrences of this condition has met the criterion specified for an alarm message The specified alarm criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Alarm Criteria is automatically reset Irregular Flow Rate Stop The number of consecutive occurrences of this condition has met the criterion specified for a stop message The specified stop criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Stop Criteria is reset when the Start Stop button is selected HGB Power Low Alarm The number of consecutive occurrences of this condition has met the criterion specified for an alarm message The specified alarm criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Alarm Criteria is automatically reset HGB Power Low Stop The number of consecutive occurrences of this condition has met the criterion specified for a stop message The autosampler halts at the same time the stop message occurs The specified stop
361. oubleshooting the Analyzer 5 15 5 16 AN WARNING To avoid possible injury that may occur from laser radiation do not remove the laser safety shield You must not remove the flowcell if the laser safety shield is not in place on the laser optics assembly MESS a f O LASER SAFETY SHIELD DO NOT REMOVE LASER WARNING To avoid damage to the eyes never look directly at the laser beam or at its reflection from a shiny surface All field service procedures must be followed precisely Only Siemens trained field service personnel should perform procedures related to laser assemblies For more safety information and laser specifications refer to Safety Information Protecting yourself from lasers 1 Make sure that the analyzer is in the Standby mode 2 Open the optics cover The RBC flowcell is on the left Perox flowcell 1 RBC flowcell 2 3 Disconnect the shuttle line 1 the sample stream input line 2 and the sheath stream input line 3 from the CFM Allow these lines to hang freely Troubleshooting the Analyzer 1 SHEATH NIPPLE 2 SAMPLE NIPPLE 3 SHUTTLE NIPPLE 4 Locate hydraulic valve 23 Unscrew the threaded fitting from the top left hand side of the valve To Waste Reagent 5 Loosen the captive flowcell release screw then remove the flowcell Flowcell 1 flowcell release screw 2 6 Hold the flowcell by the red threaded fitting when lifting the flowcell out of the op
362. ove from field to field Select tests Select OK to confirm the entries The Access dialog box appears for the next workorder Creating Workorders by Patient 1 2 At the Access menu select Pat In the Pat box enter the patient number then select Enter or select OK If there is more than one workorder for this patient they are listed Select Create to make a new workorder for this patient Enter sample and patient information Use the Tab key to move from field to field You must enter a sample ID number Select tests Select OK to confirm the entries The Access dialog box displays for the next workorder Creating Workorders by Patient Name 1 2 At the Access menu select Name In the Name box enter the patient name then select Enter or select OK To view patient list type then press the Tab key If the entered patient name already exists you can 3 5 3 6 Select Create to make a new workorder for this patient Select New Patient to create a new patient file for this name Enter sample and patient information Use the Tab key to move from field to field You must enter a sample ID number Select tests Select OK to confirm the entries The Access dialog box displays for the next workorder Listing the Pending Workorders 1 2 3 4 At the Customize menu select Tools View When the tools list appears double select File Management Select the Pending check box
363. ox channel and continue normal operation If the value is less than 119 select Set Light Intensity Check the gains for the Perox channel Reprogramming the Manual Barcode Reader 1 Locate the Codabar Settings in the Opticon User s Manual 2 Scan the Start Z7 barcode with the wand The barcode reader should be emitting a constant beeping sound which is an indication that it is in the programming mode 3 Scanthe Do not transmit Start Stop F0 barcode You should hear a single high pitched beep to indicate that the scanning was successful 4 Scan the Z7 barcode label A continuous beeping sound indicates that the reprogramming is finished Cleaning Procedures Backflushing the Drain Filters If a drain filter is clogged replace it with a new filter If the filter is not clogged but you want to clean it because of heavy buildup or discoloration use this backflush procedure Materials required e Flowcell cleaning kit PN 113 B711 01 e Household bleach Time 10 minutes Analyzer mode Off Troubleshooting the Analyzer 5 5 5 6 BIOHAZARD All products or objects that come in contact with human or animal body fluids should be handled before and after cleaning as if capable of transmitting infectious diseases Wear facial protection gloves and protective clothing The operator should follow the recommendations to prevent the transmission of infectious agents in health care settings as recommended for
364. p value is greater than 1 96 Use the side alignment screw moves the lamp in a horizontal direction 2 and the top alignment screw moves the lamp in a vertical direction 3 to peak the position of the lamp The maximum value should be between 1 96 and 4 99 volts However if the volts are greater than 4 90 select Set Light Intensity first then return to the Perox Lamp Adjustment window select Start Cycles and repeat this procedure a In small increments first turn the side screw then the top screw clockwise If the voltage goes down turn the screws counterclockwise b Continue alternately turning the screws in small increments until the maximum value is achieved The final adjustment should be in the clockwise direction Allow 5 to 10 seconds for the screen to update between each increment Troubleshooting the Analyzer NOTE Achieve the final maximum lamp value in a clockwise direction only This will counteract any spring bounce that might decrease the output level of the lamp over time 7 Once the value is maximized tighten the securing screws 1 to lock the lamp into position Some minor drifting less than 0 1 volts is normal 8 At the Utilities menu select Analyzer Status and check the lamp intensity e Ifthe value is at least 120 but less than 255 the perox light source indicator although displayed in red is acceptable for reporting results Results will not be flagged Check the gains for the per
365. panel 2 At the Utilities menu select Analyzer Status 3 Monitor the pneumatic values on the screen as you adjust the appropriate knob 20 IN HG VACUUM 5 PSI PRESSURE REGULATOR KNOB REGULATOR KNOB 20 PSI PRESSURE 40 PSI PRESSURE REGULATOR KNOB REGULATOR KNOB Turn knobs clockwise to increase values and counterclockwise to decrease values Troubleshooting the Analyzer 5 3 5 4 You have to first pull the 20 and 40 psi pressure regulator knobs then turn to adjust Regulator Acceptable Reading Set to 20 in Hg vacuum 20 1 in Hg 20 0 5 in Hg 20 psi pressure 20 1 psi 20 1 psi 5 psi pressure 5 0 5 psi 5 0 25 psi 40 psi pressure 40 2 psi 40 1 psi IMPORTANT All pneumatic settings must be reached by turning the knobs in an upward or clockwise direction only If a reading goes above the target value see column 3 on the left turn the knob back Allow the analyzer to equilibrate get a new reading every 5 seconds then adjust upward to the correct value Maximizing the Perox Lamp Output The analyzer should be in the Ready to Run mode If it is in Standby the current A D reading will not update 1 2 3 4 5 At the Procedures menu select Adjust Select Perox Lamp Alignment Select Start Cycle Monitor the Current A D Reading field Loosen the two securing screws 1 Do not loosen the four corner screws 4 Perform the following procedure even if the initial maximum lam
366. phils falling in the Neutrophil Region of the CSF Scatter Scatter cytogram Due to their scatter scatter properties both neutrophils and eosinophils fall in this region of the CSF Scatter Scatter cytogram The number of CSF PHA Eos is identified in the Eosinophil Region of the CSF Scatter Absorption cytogram and subtracted from the number of cells in the Neutrophil Region of the CSF Scatter Scatter cytogram to determine the CSF PHA Neuts CSF PHA Neuts cells in Neutrophil Region CSF Scatter Scatter Cytogram CSF PHA Eos CSF Scatter Absorption Cytogram Methods Methods Parameter Explanation CSF R Count The number of cells falling in the Red Cell Region of the CSF Scatter Scatter cytogram Parameter Key CSF WBC The reportable CSF white blood cell count WBC uL CSF PMN The reportable CSF absolute polymorphonuclear cell count CSF PMN The reportable CSF differential percentage polymorphonuclear cell count CSF MN The reportable CSF absolute mononuclear cell count CSF MN The reportable CSF differential percentage mononuclear cell count CSF Neut The reportable CSF absolute neutrophil cell count CSF Neut The reportable CSF differential percentage neutrophil cell count CSF Lymph The reportable CSF absolute lymphocyte cell count CSF Lymph The reportable CSF differential percentage lymphocyte cell count CSF Mono The reportable CSF absolute monocyte cell count CSF Mono The reportable CS
367. plete Corrective Action Results produced when this error was triggered are invalid Repeat sample aspiration for the affected samples Sample SID Not Found Printing Aborted The sample displayed in the Review and Edit window does not exist in the database The system cannot provide the requested printout Corrective Action Correct the problem using the Key list in the Format window Sample Status THE STATUS Sid x R amp P y A sample with this status could not receive results The results received for this sample have been refused Corrective Action In the Customer Parameters window modify the parameter that specifies each sample status allowed to receive results Status Line messages Sample xxx Is Not Transmitted to the Host There is a transmission problem to the host computer The message specifies the Sid of the nontransmitted samples Another message will follow identifying the specific problem Scan Denied Reset Autosampler Barcode reader is unable to scan Possible Cause Corrective Action 1 Faulty barcode At the analyzer touchpad select Off reader cabling b Wait about 1 minute and select On to restart the analyzer If the problem persists call Siemens Service for assistance 2 Faulty barcode See la b reader SD Not Defined For Test xx Control xxyyzzz No standard deviation is defined for this test and for this control in the Control Dictionary Corrective Action Defi
368. plicate assay of 60 whole blood specimens obtained from an adult population of assumed healthy individuals Parameter Low Value High Value 10 L 40 79 0 8 2 1 CHr pg 24 36 Regulatory Information Performance Characteristics Imprecision A total of 18 runs were performed using multiple samples The following estimates of imprecision were obtained by taking 25 aspirations from each whole blood sample Each of the sample selectivity modes was tested by sampling from opened tubes and with the manual and automated closed tube samplers Standard Parameter Mean Deviation CV RETIC 10 57 8 72 13 3 1 2 0 16 13 3 CHr pg 28 9 0 2 0 7 Performance Characteristics Correlation Data The performance of the ADVIA 120 Hematology System was compared with the performance of the Technicon He3 RTC System x using whole blood from 60 normal donors and 70 hospital donors with each sample run in duplicate n 260 The following regression statistics were computed using a protocol similar to that recommended in the NCCLS document EP9 A Method Comparison and Bias Estimation Using Patient Samples Approved Guideline 1995 Comparative System Regression Parameter or Method Equation y r Sy x RETIC 107L Technicon He3 RTC 0 79x 7 8 0 903 13 6 Technicon He3 0 82 0 2 0 925 0 4 CHr pg Technicon He3 0 96 4 2 0 940 17 x Technicon He3 RTC system y ADVIA 120
369. ply a disposition to an individual result a Right select the D column next to the test you want to receive the disposition Select the desired disposition None cancels any previous disposition Rerun repeats test with no dilution using the same sample ID The letter R displays in D box Exchange swaps information in C RES and PREV RUN boxes The letter X displays in D box Accept indicates result approved by operator The letter A displays in D box Delete erases the result The letter D displays in D box Dil Sample repeats test with specified dilution using a different sample ID When result is available select Dil Cons Diluted sample Consolidation to enter result into original sample record Only Accept and Delete are available for control samples The disposition takes effect when you validate the results e Apply a disposition to all results a Select Global Disposition or select the Sample menu and then choose Global Disposition Select the desired disposition See available dispositions above The disposition takes effect when you validate the results 5 Select OK to validate the sample results NOTE Be sure to complete sample validation steps 1 through 5 before rerunning a sample If not the sample is rerun with the default selectivity Daily Routine 3 9 Ending Each Shift 3 10 Washing the System Perform the system wash procedure at the end of each shift or work period a maxi
370. potentially infectious specimens in Protection of Laboratory Workers from Infectious Disease Transmitted by Blood Body Fluids and Tissue 2nd edition Approved Guideline 1997 Document M29 A National Committee for Clinical Laboratory Standards NCCLS This document contains complete information on user protection and it can be used as reference material for instructions on laboratory safety To backflush the drain filters 1 Turn the analyzer off 2 Prepare a 10 household bleach solution 3 Unscrew the fittings from each end of the drain filter that you want to flush UNSCREW BOTH FITTINGS 4 Attach the syringe to the bottom of the filter 5 Insert the filter into the beaker of bleach solution Gently pull the syringe plunger up drawing fluid through the filter Make sure the direction of flow is the opposite of the flow during normal operation 6 Disconnect the syringe and empty it Troubleshooting the Analyzer AN WARNING The debris flushed from the drain filters may contain biohazardous material and should be treated as if it 1s capable of transmitting infectious diseases DIRECTION OF FLOW 7 Rinse the filter by repeating steps 4 through 6 twice using deionized water instead of the bleach solution 8 Visually inspect the filter and repeat the procedure if necessary 9 Wipe the outside of the filter using a lint free cloth or paper towel 10 Reinstall the drain filter 11 Cl
371. pt the sample line on the autosampler to the centering collar Analyzer Autoslide centering MCTS centering collar collar om Va E v46 8 Remove the needle cover and carefully replace the collar over the needle On the autosampler centering collar be sure to turn the spring loaded knob back to its original position 9 On the autosampler reposition the autosampler aspirator assembly Make sure that it drops firmly in place over the guide pins then reconnect the sample line to the base of the centering collar AN CAUTION After repositioning the aspirator assembly finger tighten the thumb screws being careful that they are not cross threaded Overtightening of the screws can warp the baseplate which will cause misalignment of the sampler Mis threading the thumb screws can cause needle damage 10 Place the tubes going to the autosampler centering collar into the hook on the side of the IDee reader 11 Snap the manual sampler centering collar into place 12 Close the analyzer cover 13 Turn on the analyzer power 14 Check saline background count and run whole blood primers to verify system performance To remove the centering collar from the autosampler Maintaining the Analyzer 4 5 1 Tilt the front cover down 2 Remove the sample line 1 from the bottom of the needle base AN CAUTION You must remove the sample line before the aspirator assembly is tilted forward If the line stays
372. quipment Use universal caution For complete biohazard statement refer to section on Autoslide Safety Information and Warnings AN METHANOL SAFETY For complete methanol safety statement refer to section on Autoslide Safety Information and Warnings ADVIA Autoslide Slide Maker Stainer 10 5 ADVIA Autoslide Slide Maker Stainer specific symbols Orns Spur ws Rinse Buffer Water Water Sensor Stain Waste Sensor STN CH30H sm Q STN Om Methanol Stain 1 Stain 2 Stain Waste Main Supply Connection 3 E S Y Do not Obstruct Glass Particle Slide Orientation Fan Tray Autoslide Safety Information and Warnings IMPORTANT Installation connection and disconnection of the ADVIA Autoslide Slide Maker Stainer must be performed by authorized personnel only Before moving the instrument contact your local service provider or distributor for necessary information Use the lifting handles delivered with the instrument to lift or move the instrument Before shipping the instrument whatever the destination an external decontamination must be carried out Perform a general cleaning of the instrument before transporting disposing of or temporarily removing it from use The Autoslide must be stored and shipped at a temperature of between 20 C and 4 50 BIOHAZARD All products or objects that come in contact with human or animal body fluids should be handled before and after cleaning as if capable of transm
373. r manual door 10 50 ADVIA Autoslide Slide Maker Stainer Event Text Severity Probable Cause Suggested Action Autoslide Command Error Warning Autoslide command error or Retry the command EEPROM failed Autoslide Daily Shutdown Warning An error occurred that prevented Check message log for errors correct Incomplete the autoslide daily shutdown from any problems and retry the daily completing shutdown If still not successful perform a Mechanical Initialization and then retry the daily shutdown Autoslide Daily Startup Warning An error occurred that prevented Check message log for errors correct Incomplete the autoslide daily startup from any problems and retry the daily completing startup If still not successful perform a Mechanical Initialization and then retry the daily startup Autoslide is Processing Warning Attempt was made to go toa Wait until all slides are completed Slides configuration screen while slides before attempting to change were being processed configuration Autoslide Manual Inlet Warning The manual inlet door cannot be Enable the stainer in the Autoslide Door Cannot be Opened opened because the stainer is options menu or stop Autosampler if enabled for use or the ADVIA appropriate and try again 2120 2120i Autosampler is active Autoslide Manual Inlet Warning An error occurred while attempting Check for something blocking the Stat Door Failed to Open
374. r diode light source This optical assembly is shared by the RBC PIt retic and baso lobularity channels The use of a sheath stream in the flowcell allows cell by cell measurement of low and high angle light scattering and absorption Perox Optical Assembly The perox optical assembly measures scattering and absorption of a tungsten light beam as it passes through a stream of prepared white blood cells in a flowcell lt a G o O O A Tungsten Lamp D Sample Stream G Absorption PC Board E Filter Dark Field Stop Welcome to the ADVIA 2120 2120i Hematology System 1 7 B Slit Aperture F Beam Splitter Scatter PC Board C Circular Aperture 1 The image of a rectangular slit illuminated by the light from the tungsten lamp is focused into the flowcell and onto the photodiodes on the scatter and absorption PC boards The detected signal pulses from cells passing through the slit image are proportional to the optical power scattered into defined angles and the optical power absorbed or lost The resulting scattering and absorption of the light from each white blood cell is due to the size and staining characteristics of each cell 2 The dark field stop intersecting the light beam going to the scatter photodiode only accepts light scattered at angles between 5 and 10 3 The absorption signals are collected over a 0 and 10 angular interval 4 Th
375. ram shows the overlaid distribution of mature RBCs and reticulocytes by their cell volume independent of hemoglobin concentration RETIC HC histogram shows the overlaid distribution of mature RBCs and reticulocytes by hemoglobin concentration independent of cell volume Methods Methods RETIC CH histogram shows the overlaid distribution of mature RBCs and reticulocytes by hemoglobin content cellular hemoglobin RETIC Scatter Abs cytogram is formed from the paired high angle low gain light scatter and the high gain absorption data Sample specific thresholds separate the cell populations RETIC Scatter cytogram is formed by plotting the high angle low gain light scatter along the x axis and the low angle low gain light scatter on the y axis RETIC V HC cytogram provides a representation of the cell volume and hemoglobin concentration Reticulocyte Method Nomenclature Mature m Reticulocytes r Gated g The lowercase letters m r and g are commonly used in the reticulocyte parameters to identify a specific population For example MCVm MCVr and MCVzg refer to the mean cell volume for the mature RBC reticulocyte and gated populations respectively Gated refers to the total population of RBCs containing both mature RBCs and reticulocytes Negative versus Positive Cell Populations Since reticulocytes have RNA and stain with ADVIA 2120 2120i autoRETIC reagent they are the positive cell population Mature RBCs d
376. raphy Kerker M The Scattering of Light and Other Electromagnetic Radiation Academic New York NY Chapter 3 1969 Groner W and Tycko DH Characterizing blood cells by biophysical measurements in flow Blood Cells 6 141 157 1980 Hemoglobin Concentration The hemoglobin method is a modification of the manual cyanmethemoglobin method developed by the International Committee for Standardization in Hematology ICSH Bibliography ICSH Recommendations for Reference Method for Hemoglobinometry in Human Blood ICSH Standard EP 6 2 1977 Regulatory Information REF 09826813 REF 08008297 Specifications for international hemoglobincyanide reference preparation ICSH Standard EP 6 e 1977 J Clin Pathol 31 139 1978 Indices The red cell indices MCH and MCHC are derived from the mathematical calculation of the RBC count the total hemoglobin and the MCV determination The HCT value is calculated from the RBC count and the MCV The RDW and HDW values are calculated from the cell by cell measurement of cell volume and hemoglobin concentration The CH represents the mean of the cell hemoglobin content histogram The is calculated as the mean of the RBC hemoglobin concentration histogram Bibliography Wintrobe MM The size and hemoglobin content of the erythrocyte J Lab Clin Med 17 899 911 1932 Bessman JD What s an 7RDW Am J Clin Pathol 76 242 1981 Mohandas N et al Accurate and independent measurement of
377. rate 10 mL of the bleach followed by 10 mL of deionized water At the Exerciser select V45 to close the valve Replace the tubing on the centering collar nipple and exit the Exerciser window Cleaning the Vent Lines Vacuum Shuttle Chambers and Reaction Chambers Materials required Beaker Deionized water EZ KLEEN for cleaning perox related pathways and chambers Household bleach for all pathways and chambers other than perox Tubing 0 090 PN 116 0536 16 Time 4 minutes Analyzer mode Ready to Run Troubleshooting the Analyzer 5 9 5 10 NOTE Clean one vent line or chamber at a time 1 Remove the tubing from the overflow bottle that leads to the vent of the pathway or chamber that you want to clean Or if there is no overflow tube installed attach a 12 inch 300 5 mm 0 081 ID piece of tubing to the vent Put the free end of the tube into a beaker of 25 solution of household bleach and water IMPORTANT You must use EZ KLEEN when cleaning the perox vacuum shuttle chamber and perox vent line Open the valve that will create a vacuum to aspirate the bleach solution from the beaker through the vent line and chamber to the main waste line at the bottom of the UFC block To open a valve at the Utilities menu select the Exerciser tab Select Valves from the list on the left Select the appropriate valves The appropriate valves are Baso chamber open V13 Perox vacuum shuttle chamber open V18 and V17 Re
378. ration area The B SAT BS flag may cause a substitution of the WBC count Flags 6 29 6 30 The following rules determine if the WBCB or WBCP count is reported for a CBC Diff sample e WBCB is the primary WBC count If B NO or B SAT flags are triggered the WBCP count is reported if valid Ifa B NO flag and a PX NO or PX SAT flag are triggered the count is reported with a sample system flag e WBCB is reported as the WBC count for samples with WBC lower than 1 0 x 105 uL Results Flagged WBCB Corrective Action Multiple occurrences of this flag especially for consecutive samples can indicate a system problem However isolated instances of this flag are usually sample related The following list of sample related causes may not contain all conditions that could cause this flag There is no intention to associate the flag with specific diagnoses System Related Sample Related 1 Check baso reagents e Leukemia 2 Check the pressure and vacuum readings high WER 3 Check sheath delivery 4 Check baso hydraulics 5 Check RBC Baso Retic flowcell alignment Baso Temperature out of Range BTO TB Definition The Baso Temperature Out of Range flag is triggered if the baso reaction chamber temperature is not between 31 9 C and 34 1 C The BTO TB flag is not triggered if agreement between the baso and perox results is indicated by both the following conditions e WBCB
379. rdance with the procedures described in the applicable Product Labeling online documentation package inserts bulletins and for determining that product performance conforms to the applicable claims If under these prescribed conditions of operation and maintenance an aberrant or abnormal result as defined by the laboratory protocol occurs laboratory personnel should first make certain that the system is performing and is being operated in accordance with the Product Labeling then follow the laboratory protocol for advising the clinician of a result that appears to have deviated from the norms established by the laboratory Regulatory Information 9 9 9 10 Siemens products do not make diagnoses on patients Siemens intends its diagnostic products systems reagents software hardware to be used to collect data reflecting the patient s chemical hematological or immunological status at certain point in time Such data must be used in conjunction with other diagnostic information and with the attending physician s evaluation of the patient s condition to arrive at a diagnosis and a clinical course of treatment Any malfunction of a Siemens diagnostic product for example failure to meet a performance specification or to perform as intended should be appropriately addressed by laboratory personnel Various sections of the Product Labeling address malfunctions and their possible effect on results Waste Disposal Requirements
380. re Slide did not make it to the carrier Clear slide and inspect area for glass in time or loaded incorrectly particles or debris then refer to Troubleshooting Tip 2 ASL Smearing Error Failure Smearer door was open Run Close smearer door reset smearer Stop stopped if Alarm Stop criteria set see Tip 2 ASL Smearing module Failure Smearing module door is open Close the smearing module door reset door is open smearer if necessary ASL Smearing module Failure Smearing module is not primed Run prime smearer hydraulic cycle and not primed reset smearer Perform Daily Startup if necessary ADVIA Autoslide Slide Maker Stainer 10 49 Event Text Severity Probable Cause Suggested Action ASL Smearing module Failure Smearing module problem Reset smearer Call Siemens not ready ASL Smearing tape is Failure Smearing film empty broken or Perform the smearing film replacement loose incorrectly threaded procedure Be sure to check smearing wedge for cleanliness ASL Stainer error Failure Stainer error Reset autoslide see Tips 2 amp 3 ASL Stainer module Failure Stainer module door is open Close the stainer module door Perform door is open a mechanical initialization if necessary ASL Stainer not primed Failure Stainer is not primed Check message log to see if daily startup has been done perform a daily startup or Stainer Prime if daily startup was comple
381. reagents are mixed and the cytochemical reaction takes place 2 There are five reaction chambers 3 1 Hgb Reaction Chamber Not Visible 4 Baso Reaction Chamber RBC Reaction Chamber Retic Reaction Chamber a Ff N Perox Reaction Chamber The perox reaction chamber 5 is temperature controlled The mixture of sample and three reagents PEROX 1 PEROX 2 and PEROX 3 is heated to achieve the desired cytochemical reaction Welcome to the ADVIA 2120 2120i Hematology System The baso lobularity reaction chamber 2 is temperature controlled The mixture of sample and reagent is heated to achieve the desired cytochemical reaction The Hgb reaction chamber 1 serves as an optical cuvette in which the hemoglobin measurement is read The RBC PIt and retic reaction chambers 3 and 4 serve as containers in which the reagents and samples are mixed for the desired cytochemical reaction Optical Assemblies The perox optical assembly 1 directs light from a tungsten halogen lamp to the perox flowcell The use of a sheath stream in the flowcell allows a cell by cell measurement of light scatter and absorption The hemoglobin colorimeter assembly 2 takes voltage readings that correspond to the amount of transmitted light that passes through the reaction chamber The system uses the readings to derive the hemoglobin concentration The laser optical assembly 3 uses a lase
382. reconnect the level sensor switch 1 and turn the mode selector knob 2 back to the NORMAL setting Daily Routine 3 3 3 4 gt gt Emptying the Overflow Bottle IMPORTANT If liquid consistently accumulates in the overflow bottle call your local service provider or distributor BIOHAZARD WARNING All products or objects that come in contact with human or animal body fluids should be handled before and after cleaning as if capable of transmitting infectious diseases Wear facial protection gloves and protective clothing The operator should follow the recommendations to prevent the transmission of infectious agents in health care settings as recommended by the Clinical and Laboratory Standards Institute formerly NCCLS in Protection of Laboratory Workers from Occupationally Acquired Infections Approved Guideline Third Edition 2005 CLSI Document M29 A3 This document contains complete information on user protection and it can be used as reference material for instructions on laboratory safety 1 Visually check the fluid level in the small overflow bottle 1 located to the right of the RBC sample and sheath pumps If it has any liquid in it empty the bottle 2 Snap the bottle 1 out of the clip then remove the bottle cap 2 You can allow the lines 3 with the cap to 2 hang loosely le 3 Empty the contents of the bottle in accordance with proper laboratory practices and environme
383. rection Factor 8 53 Parameter Explanation RBC Fragments Count of RBC Fragments RBC Ghosts Count of RBC Ghosts Parameter Key Dilution Factor The dilution factor for the PLT channel is 83 33333E 3 PLT Platelet count MPV Mean Platelet Volume Large PLT The count of platelets with volumes greater than 20 fL is derived from the Platelet Volume histogram based on Integrated Analysis Large Platelet Count in the same units selected for PLT on the Unit Set Configuration window of the System Setup tab RBC Fragments This count includes events in the RBC Fragment area of the PLT Scatter cytogram that have volumes less than 30fL and refractive indexes greater than 1 400 1 RBC Ghost area 2 Platelet area 3 RBC Fragment area The RBC Fragments Count is in the same units selected for RBC on the Unit Set Configuration window of the System Setup tab Methods Methods RBC Ghosts This count includes events in the RBC Ghost area of the PLT Scatter cytogram that have refractive indexes lower than 1 350 uu NS 1 RBC Ghost area 2 Platelet area 3 RBC Fragment area The RBC Ghosts Count is in the same units selected for RBC on the Unit Set Configuration window of the System Setup tab MPC Mean Platelet Component Concentration MPM Mean Platelet Dry Mass PCDW Platelet Component Distribution Width PDW Platelet Volume Distribution Width PMDW Platelet Dry Mass Distribution Width PCT Platelet Crit RBC Frac
384. red Critical Sampler Error Full Reset is required Air lines supplying the centering collar are pinched Faulty output queue sensor or sensor wiring Close the autosampler access door The autosampler will reset a At the analyzer touchpad select Off Wait about minute and select On to restart the analyzer If the problem persists call Siemens Service for assistance Open the autosampler access door Check for kinked or pinched tubing Replace if necessary Close the autosampler access door The autosampler will reset If the problem persists call Siemens Service for assistance Call Siemens Service for assistance Autosampler Collar Failed to Extend Reset Autosampler The autosampler centering collar failed to extend properly Possible Cause Corrective Action 1 Critical a Open the autosampler access door b Close th door Th Error Partial lose the autosampler access door The autosampler will reset Reset is required 2 Critical At the analyzer touchpad select Off 1 Shi Wait about 1 minute and select On to restart the Error Full 1 Reset is required Ifthe problem persists call Siemens Service for assistance Status Line messages 7 19 Air lines supplying the centering collar are pinched Faulty output queue sensor or wiring Open the autosampler access door Check for kinked or pinched tubing Replace if necessary Close the autos
385. rences of this condition has met the criterion specified for a stop message The autosampler halts at the same time the stop message occurs The specified stop criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Stop Criteria is reset when the Start Stop button is selected Status Line messages 7 41 7 42 BASO Temperature Out Alarm The number of consecutive occurrences of this condition has met the criterion specified for an alarm message The specified alarm criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Alarm Criteria is automatically reset BASO Temperature Out Stop The number of consecutive occurrences of this condition has met the criterion specified for a stop message The autosampler halts at the same time the stop message occurs The specified stop criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Stop Criteria is reset when the Start Stop button is selected Blasts Alarm The number of consecutive occurrences of this condition has met the criterion specified for an alarm message The specified alarm criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Alarm Criteria is automatically reset Blasts Stop The number of consecutive occurrences of this condit
386. rformance data for the methods were obtained using ADVIA 2120 2120i instruments software reagents standards and controls designed for or intended for use on the ADVIA 2120 2120i Hematology System Statement of Content The Introduction contains information on ancillary reagents controls and calibrators for the ADVIA 2120 21201 Hematology System The procedures necessary for the preparation use and storage of the ADVIA 2120 21201 Hematology System method reagents are provided in the applicable method topics Sample Collection and Preparation BIOHAZARD WARNING All products or objects that come in contact with human or animal body fluids should be handled before and after cleaning as if capable of transmitting infectious diseases Wear facial protection gloves and protective clothing The operator should follow the recommendations to prevent the transmission of infectious agents in health care settings as recommended for potentially infectious specimens in Protection of Laboratory Workers from Infectious Disease Transmitted by Blood Body Fluids and Tissue 2d edition Approved Guideline 1997 Document M29 A National Committee for Clinical Laboratory Standards NCCLS This document contains complete information on user protection and it can be used as reference material for instructions on laboratory safety Refer to the Information Bulletin titled Sample Handling Guidelines Publication No TN9 5729 31 Collect sample
387. rm The number of consecutive occurrences of this condition has met the criterion specified for an alarm message The specified alarm criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Alarm Criteria is automatically reset PEROX Saturation Stop The number of consecutive occurrences of this condition has met the criterion specified for a stop message The autosampler halts at the same time the stop message occurs The specified stop criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Stop Criteria is reset when the Start Stop button is selected PEROX SHEATH Pump Error Reset Required PEROX SHEATH syringe pump not in home position failed to respond or a transmission error occurred Possible Cause Corrective Action 1 PEROX SHEATH Reset the analyzer by selecting Utilities syringe pump not Exerciser Indicators Analyzer Reset not b After about 1 minute if the status line does not home position display Ready to Run and the green ready to aspirate light is still off follow these steps to exit the ADVIA 2120 21201 software turn off the analyzer and then restart i Select Shut Down ADVIA at the Log On Off window ii Select Off at the analyzer touchpad iii Select CTRL ALT DELETE and log back onto the system to restart the software iv Restart the analyzer by selecting O
388. rm message Possible Cause Corrective Action 1 Barcode label Verify that a barcode is present and correctly applied to improperly the sample tube with the label flush against the rim of placed the stopper Verify that the barcode is clean and of obscured or specified quality not present 2 Barcode reader Call Siemens Service for assistance faulty Sample ID Not Read Stop Sample tube barcode label is unreadable or missing The number of consecutive occurrences of this condition has met the criterion specified for a stop message and the autosampler has halted Possible Cause Corrective Action 1 Barcode label Verify that a barcode is present and correctly applied to improperly the sample tube with the label flush against the rim of Status Line messages 7 87 7 88 placed the stopper Verify that the barcode is clean and of obscured or specified quality not present 2 Barcode reader Call Siemens Service for assistance faulty Sample Rejected SID The results for the last aspiration of this sample have been rejected This sample record is full A sample record can hold only 110 results including C Res Prev Run and Prev Res Corrective Action Create a new workorder with the same patient demographics and assign a new SID Label the sample tube again with the new SID and run Sample Result Data Communication Failure The Align Optics or Direct Optics cycle was exited before result processing was com
389. roblem persists call Siemens Service for assistance Autosampler Centering Collar Extend Denied To prevent the collision of autosampler components the system did not execute the command to extend the autosampler centering collar Autosampler Centering Collar Failed to Extend Reset Autosampler The autosampler centering collar failed to extend properly Possible Cause 1 Critical Sampler Error Partial Reset is required 2 Critical Sampler Error Full Reset is required 3 Airlines supplying the centering collar are pinched 4 Faulty output queue sensor or wiring Corrective Action a Open the autosampler access door b Close the autosampler access door The autosampler will reset a Atthe analyzer touchpad select Off b Wait about 1 minute and select On to restart the analyzer c Ifthe problem persists call Siemens Service for assistance Open the autosampler access door b Check for kinked or pinched tubing Replace if necessary Close the autosampler access door The autosampler will reset d Ifthe problem persists call Siemens Service for assistance Call Siemens Service for assistance Autosampler Centering Collar Failed to Retract Reset Autosampler The autosampler centering collar failed to retract properly Possible Cause 1 Critical Sampler 7 18 Corrective Action a Open the autosampler access door Status Line messages Error Partial Reset is requi
390. rom the reagent bottle as shown by the red arrow in the figure to the right Make sure not to damage the tube sleeve on the valve 3 Prime the reagent lines Visually verify that the lines are priming 4 Runcontrols Replacing the Front Shear Face or the Shear Valve Rotor Materials required e ADVIA TESTpoint controls e Calibrators as required e Front shear valve face PN 067 0558 01 e Shear valve rotor PN 067 0876 01 e Whole blood Time Replacement 5 minutes Checkout 15 minutes Analyzer mode Standby Troubleshooting the Analyzer 5 29 5 30 BIOHAZARD All products or objects that come in contact with human or animal body fluids should be handled before and after cleaning as if capable of transmitting infectious diseases Wear facial protection gloves and protective clothing The operator should follow the recommendations to prevent the transmission of infectious agents in health care settings as recommended for potentially infectious specimens in Protection of Laboratory Workers from Infectious Disease Transmitted by Blood Body Fluids and Tissue 2nd edition Approved Guideline 1997 Document M29 A National Committee for Clinical Laboratory Standards NCCLS This document contains complete information on user protection and it can be used as reference material for instructions on laboratory safety To remove and replace the front shear valve face or the shear valve rotor In the maintenance pr
391. rost Use slides provided by Siemens approved vendors only Limitations Wright Giemsa reagents produce high quality stained blood films However there may be personal preferences in shades and intensities of staining not satisfied by the system Results When used with the ADVIA Autoslide Slide Maker Stainer the Wright Giemsa reagents will produce a consistent stain quality to facilitate accurate and reliable interpretation Technical Assistance For customer support please contact your local technical support provider or distributor Bibliography 1 Romanowsky DL On the Question of Parasitology and Therapy of Malaria St Petersburg Medical Weekly 16 297 302 1891 2 White WL Erickson MM Stevens SC Practical Automation for the Clinical Laboratory St Louis MO CV Mosby Co pp 476 487 1972 3 Moss ED Automated Slide Staining in Haematology Can J Med Tech 30 5 169 1968 ADVIA Autoslide Slide Maker Stainer Periodic Maintenance To ensure the operating efficiency of your Autoslide be sure to follow the simple maintenance procedures scheduled below Weekly e Clean glass particle waste e Clean the stain overflow tray e Perform Weekly shutdown and startup After processing 3000 Slides e Clean the stainer wells and plate e Clean the power supply fan filter As Needed e Replace the smearing tape and cleaning the smearing wedge e Replace the printer ribbon Removing glass particle waste Sma
392. s Turning the system off Routinely 1 At the Routine Operations menu select Log On Off 2 Select Shut Down ADVIA Wait 1 2 minutes while the software shuts down 3 Setthe computer power switch to Off Exiting the ADVIA 2120 2120i software To exit the ADVIA 2120 2120i software without turning off the computer power 1 At the Operations menu select Log On Off 2 Select Shut Down ADVIA Wait 1 2 minutes while the software shuts down 3 To restart the software proceed with step 2 of Turning the Computer On 2 4 Turning the System On Off Daily Routine STARTING EACH SHIFT 2 EMPTYING THE WASTE CONTAINER EMPTYING THE OVERFLOW BOTTLE CHECKING THE REAGENTS ccscsessscecececeessssececececeesesnaececececeessaaececceecsensaaeeeeeeeceenenaees OBTAINING THE BACKGROUND COUNTS 4 PROCESSING THE SAMPLES D CREATING THE 5 5 LISTING THE PENDING WORKORDERS 6 RUNNING THE SAMPLES 0c0esesesssesssssesesesesesesesesesssesesesesesesesesesessseseeeseseesseseseseseeeeees 6 VIEWING THE SAMPLE RUN s0csesesesesesesesesessessesesesesesesesssesessessesssesesesesssesesesesseenees 8 VALIDATING THE RESULTS ENDING EACH SHIFT
393. s Analytical Ranges Linearity WBC 0 02 400x 10 uL RBC 0 0 7 0x 10 pL Plt 5 0 3500 x 10 uL Hgb 0 22 5 g dL Retic 0 2 24 5 Within Run Precision Mean WBC 7 5 RBC 5 0 Hgb 15 0 MCV 90 Plt 300 Retic 2 0 Carryover SD CV 0 2 2 7 0 06 1 2 0 14 0 93 0 7 0 78 8 8 2 93 0 25 12 5 or to 1 for all parameters Personal Computer Specifications minimum Processor Hard Drive CD RW Removable storage Network Cards Video controller Intel Celeron 2 2 GHz with 512K Cache 400MHz Front Side Bus Processor Hyper Threading Disabled 40GB 7 200 rpm IDE Hard Drive Parallel ATA DiamondMax Plus 8 40GB ATA 133 HDD 48x CD RW Read amp Write Drive NEC CD R RW Drive Model NR 9300A 3 5 1 44Mb floppy Drive Samsung SFD 321J ADNR Integrated Intel Gigabit LOM Network Interface 10 100 1000 3COM 3C900B TPC Combo card with BNC connector Intel Extreme Integrated Graphics 2 Welcome to the ADVIA 2120 2120i Hematology System 1 23 1 24 Modem Memory Sound system External Ports Speaker Operating System File System Expandability BIOS Requirements BIOS Limitations Chassis External Diskette Bays Internal Drive Bays Power supply Model Name Broadcom 94212 V 92 56K PCI Modem Model No 94212 256MB DDR SDRAM PC333 Non ECC Memory 2x128MB Integrated Sound Blaster Compatible Sound AC97 Audio 1 x parallel 1 x serial 8 x USB I
394. s Biconcave disks Howell Jolly bodies Dohle bodies Color Vibrant deep purple Pink background Light purple violet Distinct deep purple Sky blue to deep blue Light purple with distinct spaces between chromatin strands Dull blue gray with lightly stained Fine pink to violet and evenly distributed Pale purplish blue and well defined Bluish pink Reddish orange large and spherical in shape Purplish blue can have reddish tone Faint pink Distinct deep purplish blue to purplish black Distinct light blue Small blue to violet blue tend to aggregate in center Reddish to reddish pink in color intensity of stain is less in central area where cell is thinnest Dark purple Pale Blue to pale blue gray ADVIA Autoslide Slide Maker Stainer Promyelocyte Granules Dark blue to reddish blue Auer Rods Purplish red Causes of RBC Artifacts e rinsing too short e Reagents expired e Stain open for extended period e Dirty stainer e Room temperature too high e Humidity too high e Slide not dry before examination Reagents and Supplies For in vitro diagnostic use Reagents are ready to use and require no preparation REF Contents Symbols Amount 08100142 Modified Wright 0 STN 4 x 3 8 L 1 gallon 0097053 Stain Japan 08100290 Modified Wright 6 gyp 3 81 gallon Buffer 08096412 Methanol CHOH 4x 38 L 01 gallon 00096669 Japan 06837687 ADVIA Autoslide ang 101 Rinse M
395. s and reticulocytes by cell size only The histogram has a range from 0 fL to 200 fL The displayed data includes the MCV g calibration factor Mature RBC population red Reticulocyte population blue RETIC Volume Histogram Parameters MACROr Percentage of reticulocyte population with cell volumes greater than 120 fL MACROm Percentage of mature RBC population with cell volumes greater than 120 fL MACROg Percentage of gated cell population with cell volumes greater than 120 fL MICROr Percentage of reticulocyte population with cell volumes less than 60 fL Methods Methods MICROm Percentage of mature RBC population with cell volumes less than 60 fL MICROg Percentage of gated cell population with cell volumes less than 60 fL MCVr Mean Corpuscular Volume is the mean of the RETIC Volume histogram for the reticulocyte population MCVm Mean Corpuscular Volume is the mean of the RETIC Volume histogram for the mature RBC population MVCg Mean Corpuscular Volume is the mean of the RETIC Volume histogram for the gated cells MCV Delta MCVr MCVm RDWr Red cell Distribution Width is the coefficient of variation CV of the RETIC Volume histogram channels 15 to 99 for the reticulocyte population RDWm Red cell Distribution Width is the coefficient of variation CV of the RETIC Volume histogram channels 15 to 99 for the mature RBC population RDWg Red cell Distribution Width is the coefficient of var
396. s area because of their small size and lack of peroxidase staining The system uses data from the perox channel and the baso channel to derive the Nucleated Red Blood Cell NRBC count NRBC and NRBC If NRBCs are present the system corrects WBC results to account for them Platelets Clumps If present platelet clumps appear in this area The platelet clump count is not included in the WBCP and differential but it is monitored for flagging purposes Lymphocyte and Basophil Cluster Lymphocytes and Basophils appear in the same cluster because they have similar size and no peroxidase activity LUC Cluster The LUC cluster contains Large Unstained Cells atypical lymphocytes blasts and other abnormal cells Monocyte Cluster Monocytes are medium sized cells with some peroxidase activity Neutrophil Cluster Neutrophils are large cells with strong peroxidase activity Eosinophil Cluster Eosinophils have the most peroxidase activity of all the white blood cell types and are large cells approximately the same size as neutrophils Eosinophils stain so intensely that they absorb light that would otherwise be scattered Consequently eosinophils appear somewhat smaller than neutrophils and can be separated from them 8 29 8 30 Abnormal Cell Locations If abnormal cells are present their size and peroxidase activity determine their location on the PEROX cytogram Location of nRBCs on PEROX Cytogram Nucleated Red Blood C
397. s from patients receiving total parenteral nutrition TPN including high lipid dosage may exhibit falsely elevated platelet counts These samples can include lipid droplets that appear in the platelet counting region thus elevating the platelet count Expected Values The range of expected values can vary depending on age sex diet and location It is recommended that each laboratory establish its own range of expected values The following range of expected values is based upon the duplicate assay of 60 whole blood specimens obtained from an adult population of assumed healthy individuals Parameter Low Value High Value WBC 103 uL 3 8 8 6 RBC 105 uL 4 1 6 0 HGB g dL 10 16 HCT 33 57 Regulatory Information 9 29 Parameter Low Value High Value MCV fL 76 100 MCH pg 24 31 MCHC g dL 28 34 CH pg 24 35 CHCM g dL 29 34 RDW 96 12 15 HDW g dL 1 9 3 0 PLT 107 uL 140 360 MPV fL 7 9 Performance Characteristics Imprecision A total of 18 runs were performed using multiple samples The following estimates of imprecision were obtained by taking 25 aspirations from each whole blood sample Each of the sample selectivity modes was tested by sampling from opened tubes and with the manual and automated closed tube samplers Parameter Mean Standard Deviation CV WBC 102 1 5 91 0 16 2 7 RBC 10 uL 4 82 0 05 1 0 HGB g dL 13 3 0 11 0 8 MCV fL 81 0 0 3 0 4 CH pg 26 5 0 05 0 2 CHCM g dL 30 6 0 14 0
398. s in 21 0 Immature Granulocytes Alarm The number of consecutive occurrences of this condition has met the criterion specified for an alarm message The specified alarm criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Alarm Criteria is automatically reset Immature Granulocytes Stop The number of consecutive occurrences of this condition has met the criterion specified for a stop message The autosampler halts at the same time the stop message occurs The specified stop criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Stop Criteria is reset when the Start Stop button is selected Indicator and Switch Error Reset Required Potential software communication error or a hardware failure associated with the front panel switch indicator Possible Cause Corrective Action 1 Hardware failure a Reset the analyzer by selecting Utilities Exerciser Indicators Analyzer Reset b After about 1 minute if the status line does not display Ready to Run and the green ready to aspirate light is still off follow these steps to exit the ADVIA 2120 21201 software turn off the analyzer and then restart Status Line messages 7 53 i Select Shut Down ADVIA at the Log On Off window ii Select Off at the analyzer touchpad iii Press CTRL ALT DELETE and log back onto the system to restart the software
399. s in a blood collection tube or microsample blood collection device that contains EDTA as the anticoagulant Refrigerate blood samples at 2 C to 8 C if they will not be analyzed within 8 hours of phlebotomy Regulatory Information Do not assay cold specimens Allow the specimen to equilibrate to room temperature before mixing Do not warm specimen by placing it into a 37 C water bath or incubator CAUTION If the whole blood specimen is brought to room temperature quickly there is a strong tendency for the platelets to clump upon mixing Do not use previously frozen whole blood samples Freezing the blood can disrupt the cellular structure thus resulting in aberrant cell counts Unless otherwise stated no special treatment of the whole blood specimen is required However samples must be collected in the specified collection tube and gently but thoroughly mixed at the time of collection and again before sampling Calibrator and Control Products CAUTION POTENTIAL BIOHAZARD Contains human source material While each human serum or REF 09459683 REF 03410380 plasma donor unit used in the manufacture of this product was tested by FDA approved methods and found nonreactive for hepatitis B surface antigen HBsAg antibody to hepatitis C HCV and antibody to HIV 1 2 all products manufactured using human source material should be handled as potentially infectious Because no test method can offer complete assurance t
400. s of aspiration The number of consecutive occurrences of this condition has met the criterion set for a stop message Possible Cause 1 Clogged sample 2 Insufficient sample volume Sample tube may have been removed before aspiration was complete 3 Insufficient vacuum Corrective Action Check for sample clots Re aspirate sample Check vacuum gauge and adjust if necessary Status Line messages 4 Clogged clot Remove clot filter and discard as biohazardous material filter Replace clot filter 5 Loose Check connections and tighten if necessary connection in sample line 6 Clog in needle Perform a needle rinse Select Utilities menu Hydraulic Functions tab Needle Rinse 7 Bent or Replace the needle damaged Follow the steps in Replacing the Sampler Needles needle 8 Faulty Contact your Siemens Field Service representative for Conductivity assistance Detector Aspiration Paused The analyzer is unable to perform a sample aspiration or to start a hydraulic cycle when certain menus or tabs are open or when certain error messages are triggered Also the green ready to aspirate light is off Possible Cause Corrective Action 1 Aspiration is paused while Select any tab or menu button other than the following menus or tabs the ones identified at left under Possible are selected Reagent Cause Installation Backup Restore System Setup Tools Modify or with the triggering of some error messages 2
401. s of results e Complete blood counts CBC e CBC plus white cell differential counts CBC diff e Reticulocyte absolute percent and indices counts retic e CBC diff plus retic CBC diff retic e CBC retic Welcome to the ADVIA 2120 2120i Hematology System Components The ADVIA 2120 21201 Hematology System is made up of two major components e The analyzer contains all the electronics pneumatics hydraulics and sampler mechanisms as well as the on board reagent storage for all reagents DEFOAMER and wash solutions except SHEATH RINSE The waste system is a subcomponent of the analyzer 1 Autosampler 8 Sample sheath and diaphragm pumps 2 Manual open tube sampler Reagents sheath wash and rinse 3 Manual closed tube sampler ENS 10 Vacuum and pressure regulator 4 Unifluidics technology knobs 5 optical assembly 11 Touchpad 6 RBC optical assembly 12 Manual barcode reader 7 Hgb colorimeter assembly 13 Waste removal system e The personal computer includes a monitor a mouse a keyboard and the interconnect cabling Welcome to the ADVIA 2120 2120i Hematology System 1 3 Autosampler The autosampler automatically transports mixes identifies and aspirates samples in closed tubes The autosampler is a rack style sampler with a capacity of 150 sample tubes 15 racks of 10 tubes The individual racks are barcoded for rack and position numbers Allowable tube sizes Minimum Vol Tu
402. s the PLT cytogram 1 PEROX d D lt 0 15 2 Flag is not set if there is WBC agreement no WBC CE flag and EOS PMN is between 0 and 7 5 Perox Flatness gt 3 2 CBC CBC DIFF v v v v v v v v v v v v CBC DIFF RETIC v v CBC RETIC v v RETIC Flags Flag PX NO NX PX PL PX PX SAT XS PXTO TX RBCIFR RR RTCint CT RTCADA CA RTCIFR CR Flags Triggering Criteria CBC DIFF 1 Perox Noise gt 60 Y 2 Flag is not set if there is WBC agreement no WBC CE flag and EOS PMN is between 0 and 7 5 Perox light intensity lt 90 Y 1 Perox Saturation gt 10 Y 2 Flag is not set if there is WBC agreement no WBC CE flag 1 Perox chamber v temperature is not between 58 C and 72 1 C 2 Flag is not set if there is WBC agreement no WBC CE flag and EOS is between 0 7 5 RBC Flatness gt 3 2 Y Y Platelet threshold below channel 5 1 Absorption mode for Gaussian fit is not between channels 6 and 30 2 SD of RETIC Abs histogram over 80 of height 1 4 3 Measured mean absorption minus the theoretical absorption gt 30 Retic Flatness gt 3 2 CBC DIFF RETIC v CBC RETIC RETIC 6 23 Flag RTC FS FC RTC NO NO RTC L CL RTC FL RF RTCSAT CS RTC SE SE WBC CE WC WBCSUB WS 6 24 Triggering
403. scatter measurements the high angle light scatter 5 to 15 is plotted along the x axis and the low angle light scatter 2 to 3 is plotted along the y axis 8 43 8 44 1 Low angle light scatter 2 to 3 2 High angle light scatter 5 to 15 3 Mie map containing RBCs 4 Platelets detected in RBC method Using the Mie theory of light scattering for homogeneous spheres the low angle and high angle light scatter signals for each cell are transformed into volume and hemoglobin concentration values The RBC map shows the relationship between the light scatter measurements and the cell by cell characteristics of volume and hemoglobin concentration The map grid encompasses RBC volumes between 30 fL and 180 fL and hemoglobin concentrations between 19 g dL and 49 g dL For a normal specimen the RBC population appears in the center of the map However since this map is nonlinear visually evaluating red cell morphology can be difficult Use the V HC cytogram which provides a linear presentation of cell volume and hemoglobin concentration RBC Volume Hemoglobin V HC Cytogram The Volume Hemoglobin Concentration V HC cytogram is a linear version of the RBC map that appears on the RBC cytogram On the V HC cytogram hemoglobin concentration is plotted along the x axis and cell volume is plotted along the y axis Only red blood cells appear on this cytogram Methods Methods 1 60 fL volume marker 2 2120 2120i fL
404. se reaction chamber The 4 chloro 1 naphthol in ADVIA 120 PEROX 2 reagent and the hydrogen peroxide in ADVIA 120 PEROX 3 reagent stain the sites of peroxidase activity in the granules of neutrophils eosinophils and monocytes Lymphocytes basophils and large unstained cells contain no granules with peroxidase enzyme activity A constant volume of the cell suspension from the Perox reaction chamber passes through the flowcell The two fluids flow as independent concentric streams no mixing with the ADVIA 120 PEROX SHEATH stream encasing the sample stream The absorbance and the forward light scattering signatures of each blood cell are measured The optical signals are converted to electrical pulses by photodiodes After processing the information is displayed in two histograms The Perox Y histogram contains the forward scattering data cell size The Perox X histogram contains the absorption data peroxidase staining The two histograms are combined to form the Perox cytogram from which cells are identified and counted Bibliography Cremins J et al Method for the determination of differential white blood cell count US Patent 4 801 549 Ansley H and Ornstein L Enzyme histochemistry and differential white cells on the Technicon Hemalog D In Advances in Automated Analysis Technicon International Congress 1970 Volume 1 Therman Associates Miami FL p 437 1971 Saunders AM Hemalog D system recent development In Advances in A
405. seconds Each point represents the number of valid cells counted during the last 200 milliseconds RBC Volume Histogram The RBC Volume histogram represents the distribution of red blood cells by cell volume The histogram has a range of 0 fL to 200 fL RBC Volume histogram normal sample Microcytic region Normocytic region Macrocytic region 60 fL marker 120 fL marker a A O N Normal samples have a bell curve shaped distribution with a mode channel between 60 fL and 120 fL The mean corpuscular volume MCV and the red cell distribution width RDW are determined from this histogram The MCV is the mean of the of RBC Volume histogram The RDW is the coefficient of variation of the population The MCV calibration factor has been applied to the displayed data Methods Methods RBC Volume histogram microcytic sample o 1 Microcytic region Normocytic region Macrocytic region 60 fL marker 120 fL marker oa A O N In samples with increased numbers of microcytic red blood cells the histogram curve shifts to the left indicating an increase in the percentage of the cells with volumes less than 60 fL RBC Volume histogram macrocytic sample a 2 3 Microcytic region In samples with increased numbers of macrocytic red blood cells the histogram curve shifts to the right indicating an increase in the percentage of the cells with volumes greater than 2120 21201 fL Normocytic regio
406. seevasssetesscesesesocseseee 3 REGULATORY COMPLIANCE cssscccssssscccsssccsssscccsssscccccssccccssscccesscsecessssccessnses 3 STANDARDS OR 3 CE MARK REQUIREMENTS ccccecsesessscecececeesessececeecceeseseaeeecececsessaaeeeeeeeceesssaeeeeeeeceeseaeea 3 NOISE LIMIT REQUIREMENT 4 DOCUMENTA TION c e 4 SYSTEM SYMBOLS 4 INTERPRETATION OF RESULTSu cccsssccsssssecssssrcccssssecscssccccsssecsessccecsssssccessnees 9 EXPLANATION OF THE WARNING LABELS ON THE AC POWER 10 EXPLANATION OF THE WARNING LABELS ON THE MANUAL CLOSED TUBE SAMPLER 2 rh Seve eo o eo oO vn adusssvevesascusducsavesesesacdsotsenseesass 11 PROTECTING YOURSELF FROM 5 8 1 111 enne 12 RBC LASER OPTICAL ASSEMBLY 1 eene rene rennen nnn nennen 12 AUTOSAMPLER BARCODE READER eren eene nnne 13 Warnings and Safety Information B 1 Warnings B 2 ELECTRICAL WARNING To avoid exposure to shock hazards and or damage to the instrument while performing this procedure power off the analyzer before proceeding BIOHAZARD All products or objects that come in contact with human or animal body fluids should be handled before and after cleaning as if capable of transmitting infectious diseases Wear f
407. ser radiation during operation and maintenance of the laser product 1 Laser aperture B 12 Warnings and Safety Information Autosampler Barcode Reader The autosampler barcode reader is classified as a Class II laser device It has maximum power output of 1 mW at a wavelength of 670 nm a pulse duration of 90 ns and 3 6 mr units of beam divergence 1 Laser aperture in back of A LASER WARNING Some field service procedures require the removal of the protective housings that prevent human access to the laser radiation All field service procedures must be followed precisely to prevent possible eye injury from the laser radiation Only Siemens trained field service personnel should perform procedures related to the ADVIA 2120 2120i laser optics bench barcode reader Laser Hazard Precautions The following list of precautions must be observed when servicing the ADVIA 2120 2120i laser optics e Remove all jewelry from hands and wrists Do not look directly at the laser beam e Do not look at specular reflections from the laser beam e Do not place reflective objects such as screwdrivers or jewelry into the beam path e Always ensure that the laser beam is terminated with a beam stop Warnings and Safety Information B 13 B 14 Warnings and Safety Information
408. smitted by Blood Body Fluids and Tissue 2nd edition Approved Guideline 1997 Document M29 A National Committee for Clinical Laboratory Standards NCCLS This document contains complete information on user protection and it can be used as reference material for instructions on laboratory safety AN CAUTION When performing this procedure do not use force on the syringe at any time Troubleshooting the Analyzer 5 23 5 24 10 11 12 13 14 At the Utilities menu select Exerciser to open the Exerciser tab Disconnect the waste tubing 1 that comes from the RBC flowcell 2 at V23 This is the white fitting at V23 3 Fill the cleaning syringe 4 25 household bleach solution and attach it to the white fitting Refill the syringe with bleach solution as needed during the following steps Disconnect the sample tubing 5 from the top of the sample syringe 6 and place the sample tubing into a beaker to catch fluid as you backflush the flowcell Gently push the plunger on the cleaning syringe to flush the bleach solution through the RBC flowcell 2 Repeat with deionized water Reattach the sample tubing 5 to the top of the sample syringe 6 Refill the syringe with bleach solution At the Valves window of the Exerciser tab open V9 and then push the syringe to fill RBC chamber 7 with 25 bleach then open V10 to drain Close V9 and V10 Repeat with deionized water Refill the syr
409. soCalFactor BASO WBC AS x 0 0012475 BasoCalFactor BASO WBC MCTS x 0 0012475 BasoCalFactor BASO WBC OTS x 0 0012475 To view the BASO WBC calibration factors click Cal Gain Logs on the System Logs menu FracDT The fraction of time that the channel is busy processing flowcell events While the baso channel is busy identifying a particular flowcell event it is unable to process any additional events that might occur By measuring this dead time the analyzer can compensate for these events 8 15 CSF Method 8 16 Cytochemical Reactions The ADVIA 22120 21201 22120 21201 CSF Assay provides a rapid automated analysis of CSF samples by counting and distinguishing certain cell types When using the ADVIA 22120 21201 22120 2120ii CSF Assay the CSF sample is mixed with ADVIA 2120 2120i CSF Reagent which spheres and fixes the cells After a minimum 4 minute to 4 hour incubation period the prepared sample is then aspirated directly into the ADVIA 22120 2120i 22120 2120ii system Measurement The ADVIA 22120 21201 22120 2120ii CSF Assay provides a rapid automated analysis of CSF samples by counting and distinguishing certain cell types When using the ADVIA 22120 2120i 22120 2120i1 CSF Assay the CSF sample is mixed with ADVIA 2120 2120i CSF Reagent which spheres and fixes the cells After a minimum 4 minute to 4 hour incubation period the prepared sample is then aspirated directly into the ADVIA 22120 21201 22120 21201i syst
410. sonnel are authorized to take this corrective action Check sensor and associated wiring 7 37 Autosampler Startup Failed Reset Autosampler The autosampler has failed to start up A reset is required Corrective Action 1 Open the autosampler access door 2 Close the autosampler access door The autosampler resets 3 If the problem persists call Siemens Service for assistance Autosampler Tube Too High Tube is sitting too high in rack or tube exceeds specifications halting autosampler Possible Cause Corrective Action 1 Tube is Push tube down improperly b At the analyzer touchpad select Start Stop to positioned continue operations 2 Tube is too a Remove tube from rack and aspirate manually long b At the analyzer touchpad select Start Stop to continue operations Autosampler Startup Complete The autosampler has successfully completed the startup process Autosampler Unexpected Car Position Reset Autosampler The autosampler car is not in the proper position A reset is required Corrective Action 1 Open the autosampler access door 2 Close the autosampler access door The autosampler resets 3 If the problem persists call Siemens Service for assistance Awaiting Header Software communication error Possible Cause Corrective Action 7 38 Status Line messages This error can Follow these steps to exit the ADVIA 2120 21201 occur during the software and then restart following 1 Select Shu
411. stem is ready to accept the aspiration of a sample or the start of a hydraulic cycle The green ready to aspirate light is lit Results Received for Tube Not in Pending File Sid xxx Seq A set of results has been received for a sample that is not in the Pending file The set of results has been refused and deleted Corrective Action Check pending list before run Status Line messages 7 83 7 84 RETIC Absorption Distribution Abnormal Alarm The number of consecutive occurrences of this condition has met the criterion specified for an alarm message The specified alarm criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Alarm Criteria is automatically reset RETIC Absorption Distribution Abnormal Stop The number of consecutive occurrences of this condition has met the criterion specified for a stop message The autosampler halts at the same time the stop message occurs The specified stop criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Stop Criteria is reset when the Start Stop button is selected RETIC Fit Suspect Alarm The number of consecutive occurrences of this condition has met the criterion specified for an alarm message The specified alarm criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Alarm Criteria is automati
412. stop and transition the system state to Ready to Run Corrective Action Increase available patient result database space by deleting data from the sample results file Use Customize System Setup Tools Modify End of Day IMPORTANT Deleting files permanently erases data If you need an electronic copy of the data back up the files before deleting Status Line messages Pattern File Win cus Does Not Exist The file containing the customer parameters does not exist A substitute file using default values has been created Corrective Action Call Siemens Service for assistance PEROX 1 Reagent Empty Stop The number of consecutive occurrences of this condition has met the criterion specified for a stop message The reagent is empty and the autosampler has halted The specified alarm criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria Reagent Conditions Corrective Action The stop counter is automatically reset after reagents are replenished and the Reagent Installation window is updated Go to Logs Reagent Log Reagent Installation Select Start Stop to continue the run PEROX 1 Reagent Expired Present date is beyond the PEROX 1 reagent expiration date as determined by encoded reagent container barcode label or as calculated from installation date and open container stability Corrective Action Replenish expired reagents and update the Reagent Installation window Go to Logs Reag
413. stop message The autosampler halts at the same time the stop message occurs The specified stop criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Stop Criteria is reset when the Start Stop button is selected Power Pack Temperature High The internal temperature of the power supply has exceeded the maximum limit Possible Cause Corrective Action 1 Fan filters are Shut down the system and remove and clean the air dirty circulation filter as directed in the Operator s Guide 2 System internal Shut down the system temperature exceeds the maximum limit Allow the system to cool down for 15 minutes Restart the system ao 2 E amp If the problem persists call Siemens Service for assistance 3 Fans are not Verify fan operation If you suspect that a fan is not functioning working properly call Siemens Service for assistance properly 4 Faulty power Call Siemens Service for assistance pack temperature sensor Pressure Node Error Reset Required Potential software communication error or a hardware failure associated with the Pressure Node Board Possible Cause Corrective Action 1 Hardware a Resetthe analyzer by selecting Utilities Exerciser failure Indicators Analyzer Reset b After about 1 minute if the status line does not display Ready to Run and the green ready to aspirate light is still off follow these steps to exit the ADVIA 2120 21201 so
414. strument The service call is considered complete when any defects in material or workmanship have been corrected by repair or replacement and the instrument conforms to the applicable specifications When service is complete the customer receives a copy of the documentation detailing all work performed by the Siemens representative or authorized distributor Service Outside Normal Hours Customers with some exceptions may also request service to be delivered or an exchange to be initiated outside normal business hours including evenings weekend days or nationally observed holidays by contacting the nearest Siemens location or authorized distributor Service performed outside normal hours is subject to a surcharge unless the customer has in place a service product option that provides service at the time requested Replacement of Parts In performing service Siemens or its authorized distributors provide appropriate parts to repair the instrument or arranges for the exchange of the instrument or affected parts at no charge with the exception of certain parts or subassemblies that are considered Customer Maintenance Items Customer Maintenance Items include but are not limited to the following items lamps electrodes or sensors which are covered by a separate warranty reagents calibrators controls paper and pens Consult the appropriate system operator s manuals for a complete list of Customer Maintenance Items for any specific m
415. t Down ADVIA at the Log On Off analytical cycles window e Adjust Gains 2 Select CTRL ALT DELETE and log back onto the RBC RETIC system to restart the software e Align Optics If the problem persists call Siemens Service for Direct Optics assistance Bad Analysis for R Message 10402 The results message sent to the host is incorrect Corrective Action Call Siemens Service for assistance Bad Analysis for Y Message 10402 The format of the received workorder 1s incorrect The workorder cannot be created Corrective Action Call Siemens Service for assistance Bad Mixer Cal Value Reset Autosampler Mixer aspirate calibration failed while the system was in diagnostic mode Exerciser The corrective actions for this error must be performed by Siemens Service personnel only Possible Cause Corrective Action 1 Autosampler Calibrate the mixer aspirate position again Calibration error 2 Autosampler Replace autosampler CPU board CPU board fails to store calibration data in flash memory Status Line messages 7 39 7 40 Bad Test in Profile An incorrect test code is defined in a profile Corrective Action Correct the Profile Table using the List menu in the Table Dictionaries window BASO Count Suspect Alarm The number of consecutive occurrences of this condition has met the criterion specified for an alarm message The specified alarm criterion is user definable in the Customize Menu System Setup
416. t Suspect region and is available in the Baso Parameter group on the Run Screen When histogram analysis is applied the Baso Count Suspect region is located above channel 21 on the y axis and in channels 0 and 49 on the x axis Baso Cytogram Baso Cytogram cluster analysis histogram analysis 1 Basophils 2 BASO Suspect 3 Baso Saturation Results Flagged BASO BASO LYMPH LYMPH LUC LUC A four part WBC differential basophils excluded is reported with the measured BASO values displayed and flagged and with the LYMPH and LUC values also flagged Corrective Action Multiple occurrences of this flag especially for consecutive samples can indicate a system problem However isolated instances of this flag are usually sample related The following list of sample related causes may not contain all conditions that could cause this flag There is no intention to associate the flag with specific diagnoses 6 25 System Related Sample Related 1 Check baso reagents e High WBC Count 2 Check the baso reaction chamber temperature e Leukemia 3 Check baso hydraulics e High Baso count 4 Check baso gains e Aged Blood 5 Check the RBC Baso Retic flowcell alignment Treated CLL Baso Irregular Flow Rate BIFR BR Definition The Baso Irregular Flow Rate flag is triggered when the cell counting rate is erratic because of a hydraulic disturbance in the baso channel Baso flow rate is evaluated in terms of the cell co
417. t off wait at least 5 minutes before removing the lamp Materials required ADVIA TESTpoint controls e Calibrators as required e Hemoglobin colorimeter lamp PN 113 B413 01 e Hex wrench 1 16 inch 1 6 mm e Phillips head screwdriver Time Replacement 15 minutes Checkout 25 minutes Troubleshooting the Analyzer 5 33 5 34 A ELECTRICAL WARNING To avoid exposure to shock hazards and or damage to the instrument while performing this procedure power off the analyzer before proceeding Analyzer mode Off 1 Remove the screw 1 that secures the lamp adapter cap then remove the cap Be careful not to lose the two washers Keep the hardware and the cap 2 Disconnect the cables 2 3 Using the hex wrench loosen the set screw 3 to release the old lamp then remove it 4 Gently push the new lamp into the housing as far as it will go then secure it by tightening the set screw 5 Reconnect the cables Replace the lamp adapter cap and secure it with the screw 6 Turn the analyzer power on Check that there are no error messages on the Status line relating to hemoglobin colorimeter baseline readings 7 At the Operations menu select the Startup tab Select Refresh and check the Hgb baseline transmission value Hgb Trans If the baseline value is not acceptable adjust it to 4 1 8 Run controls to verify analyzer performance If controls are not acceptable then recalibrate the hemoglobin chann
418. t the analyzer touchpad Test Not Buffered cTestCode There are more than 60 tests ACTIVE in the Test Dictionary No additional tests can be stored in memory Corrective Action Cancel the selection of the active test that exceeded this limit in the Test Dictionary Select Customize menu System Setup Tools Modify Test Dictionary Tube xxx Not Transmitted to the Host An expected result was not transmitted Corrective Action Status Line messages 7 93 7 94 Check the sample status and the contents of the file before attempting to retransmit this sample The problem may be an acknowledgement problem at the host level The communication line should be checked by Siemens Service personnel Type Not Found The type of workorder sent by the host is unknown to the Data Manager No type can be associated with the test request Corrective Action Create this type in the Type Table Dictionary Select Customize menu System Setup Tools Modify Type Table Dictionary Types Table Test Doesn t Exist A test defined in the Types Table has been deleted in the Test Dictionary Corrective Action As appropriate delete the test from the Type Table or reenter the test in the Test Dictionary UFC Vacuum Out of Range UFC Vacuum is out of range The difference between the compressor vacuum and UFC vacuum is greater than 5 Hg Possible Cause Corrective Action 1 Vacuum Setting Check the system vacuum gauge and adjust the regulator
419. tating the stainer plate replace each stainer well with the notch on the bottom closest to the edge of the plate Make sure that the wells are seated properly all at the same level in the stainer tray 7 Slide the stainer tray door closed 8 Put the analyzer in Ready mode and turn off the Autoslide Cleaning the Fan Filter 1 At the back of the Autoslide turn off the power 2 Remove the fan cover and separate the filter 3 Using a vacuum or air canister clean all dust and dirt from the filter 4 Assemble the clean filter with the cover and replace it on the rear of the unit Replacing the Smearing Tape and Cleaning the Smearing Wedge BIOHAZARD All products or objects that come in contact with human or animal body fluids should be handled before and after cleaning as if capable of transmitting infectious diseases Wear facial protection gloves and protective clothing The operator should follow the recommendations to prevent the transmission of infectious agents in health care settings as recommended for potentially infectious specimens in Protection of Laboratory Workers from Infectious Disease Transmitted by Blood Body Fluids and Tissue 2d edition Approved Guideline 1997 Document M29 A National Committee for Clinical Laboratory Standards NCCLS This document contains complete information on user protection and it can be used as reference material for instructions on laboratory safety Materials requir
420. te Total drainage time will be about two and a half minutes 7 When the waste container is empty close the spigot and store the container for future use IMPORTANT Make sure that the spigot is closed securely otherwise sufficient N operating vacuum may not be reached Automatic Waste Removal CAUTION Make sure all cycles are completed before disconnecting the waste container The waste container must be connected to the system when any system cycles are in progress including the system startup cycle If the waste container is not connected fluid will back up into the UFC and damage the system IMPORTANT In order to empty the automatic waste removal system the analyzer must be on and must not be in Standby mode 1 Make sure that the analyzer is not sampling 2 Ifa message requesting a rinse or a wash appears select Cancel 3 Disconnect the level sensor switch connector 1 by selecting its button CAUTION To prevent sample aspiration while the automatic waste removal system is draining disconnect the level switch sensor Sample aspiration during waste removal may damage the analyzer 4 Atthe waste removal assembly tray turn the mode selector knob 2 from NORMAL to EMPTY 5 The waste in the container should start to empty It will take between two and five minutes to completely empty the container When you see air bubbles in the discharge line 3 the container is empty 6 Once the container is empty
421. ted followed by a mechanical initialization if necessary ASL Stainer not ready Failure The stainer subsystem is not Reset autoslide rinsed ASL Stainer under Failure Stainer wells are full with methanol Run the daily or weekly startup methanol procedure to drain the methanol ASL Staining Error Failure Stainer door was open Run Close stainer door reset autoslide Stop stopped if Alarm Stop criteria set resume run ASL Staining waste is Failure Staining Waste is full stainer Dispose of staining waste according to full enabled local regulations Perform a Reset ASL Staining Waste Full Autoslide if necessary Stop ASL Unknown error Failure Autoslide reported an error Call Siemens unrecognized by the ADVIA 2120 2120i system ASL In Pre smeared Information An operation is rejected because Wait for Stat slide to be completed slide mode STAT slide mode is in effect close manual slide entry door and try again ASL Autoslide aspiration Warning The autosampler hardware for the If system has a dual sampler perform hardware unavailable on second aspiration position is an autosampler reset If not successful autosampler inoperable or unavailable power the ADVIA 2120 2120i system off on Call Siemens ASL Autoslide is not Warning Autoslide is not ready for use Perform daily weekly maintenance as available to make slides required and try again ASL Please Close Warning Stat door is open Close the manual inlet stat doo
422. tem OVERVIEW EE 2 COMPONENTS 3 AUTOSAMPLER 5 6 eS 4 MANUAL CLOSED AND OPEN TUBE 8 2 00 0 0 5 UNIFIED EEUIDS GIRGUIT UFC ar n aba it ata One e RES 5 OPTICAL ASSEMBLIES 5 erac nette tems eie ra Ras 7 SAMPLE SHEATH AND DIAPHRAGM PUMPS sssessssccececsesecsececececsensaececceeceensaseeeess 10 REAGENTS SHEATH RINSE WASH AND DEFOAMER eene 12 VACUUM AND PRESSURE REGULATOR 5 12 tea ta dte e ER a en thats ada 12 TOUCHSCREEN sth cect tr Reto vacates ona sth ne treaties 13 MANUAL BARCODE READER ssssesssceeececsesssaececececeessaaececececeeseaececececeeneaeaeeeeeeeeneaaees 13 WASTE REMOVAL SYSTEM ccccccccccecssssssececececsesssesecececseseaaececececeeseaaeaesececsesenssaeseeeeeenes 14 HOW THE ADVIA 2120 21201 HEMATOLOGY SYSTEM WORKS cccsscsssscssscsssscssscsssessssces 15 HOW THE ADVIA 2120 21201 SOFTWARE WORKG ccsscssscssssscsssccsssscssscsssessssccessesssssssseascssses 16 STARUS MINES ee ees 16 MENUS ccm tect E A a Le mA E due te amt ted ee 17 EI 18 LEFESSIDEBUTTONS 55 6 o5 meoinat
423. ter 4 Slide the cleaned plunger into the syringe Use a little saline solution if necessary Reseat the small plastic bushing into the syringe barrel then replace the syringe a Insert the bushing end of the syringe into the slot at the bottom of the carriage b Make sure that the input port on the RBC Baso Retic channel is facing left and on the Perox channel it is facing right Slide the syringe up and into the mounting hole in the pump drive frame d Install the washer and the knurled nut and hand tighten the nut A CAUTION Be careful not to cross thread or overtighten the knurled nut and the input output fittings e Reconnect all the syringe fittings 5 Check analyzer performance by e Checking saline backgrounds e Running a whole blood primer e Running controls 4 12 Maintaining the Analyzer Replacing the Sampler Needles There are two needles in the analyzer One is located in the autosampler and the other is in the manual closed tube sampler Materials required e Cotton swab WARNING e Lens tissue The analyzer must be off otherwise personal e Replacement needle injury from the needle may occur PN 113 3301 03 Time 5 minutes per needle Analyzer mode Off Location of the sampler needles and centering collars gt Autosampler 1 Manual closed tube sampler 2 a de kele BIOHAZARD All products or objects that come
424. ters are available for patient reporting Parameter Explanation WBCB RawWBC x BasoCalFactor 1 FracDT BASO 100 x BASO Count BASO PHA Cells BASO BASO 100 x WBCB The system uses data from the perox channel and the baso channel to derive the Nucleated Red Blood Cell NRBC count NRBC and NRBC If NRBCs are present the system corrects the WBC results to account for them Additional Parameters The following parameters are for research or laboratory use only and are not for patient reporting Parameter Explanation BASO Suspect 100 x BASO Suspect BASO PHA Cells BLAST 100 x Blasts BASO PHA Cells MN 100 x MN BASO PHA Cells PMN 100 x PMN BASO PHA Cells PMN Ratio NEUTS EOS BASO Dead Time 100 x FracDT BASO Noise 100 x Noise BASO PHA Cells 8 11 8 12 Parameter Explanation BASO Saturation 100 x BASO Saturation BASO PHA Cells BASO Flatness Sum of theSquared Differences 9 x Mean Cell Counting Rate LI PMNx MNx MNx Peak X channel of Mononuclear cluster MNy Peak Y channel of Mononuclear cluster PMNx Peak X channel of Polymorphonuclear cluster Parameter Key WBCB White blood cell count from theBasophil Lobularity method BASO Absolute count of Basophils BASO Percent of Basophils BASO Suspect Percent of events from Baso Suspect area MN Percent of events from Mononuclear area PMN Percent of events from Polymorphonucle
425. th two cyanide ions The mechanism and clinical performance of the Siemens Hemoglobin method have been described The presence of carboxyhemoglobin even up to 100 has no effect on the reaction rate or transformation to the cyanated product 8 21 8 22 Bibliography Duck Chong CG Differential effect of detergents on the alkaline denaturation of haemoglobin in maternal and fetal blood with particular reference to Triton X 100 J Clin Pathol 36 910 1983 Simplicio and Schwenzer Biochem 12 1923 1983 Malin MJ Sclafani LD and Wyatt JL Evaluation of 24 second cyanide containing and cyanide free methods for whole blood hemoglobin on the Technicon H 1 analyzer with normal and abnormal blood samples Am J Clin Path 92 286 1989 Malin MJ Fan SS and Benezra J Mechanism of automated alkaline methods for the determination of hemoglobin in whole blood based on the micellization of ligated heme in the presence and absence of cyanide Anal Chim Acta 262 67 1992 Measurement Optical readings are obtained colorimetrically at 565 or 546 nm according to the method installed After processing the optical data are plotted on the hemoglobin rate curve where time in seconds is plotted along the x axis and the percent light transmission is plotted along the y axis The hemoglobin transmission histogram is divided into five parts HGB Trans eee 0 10 5 25 27 1 ADVIA2120 21201 SHEATH RINSE reading from previous cycle 2 Dr
426. than 100 000 cells uL The events counted in this area have refractive indexes lower than 1 350 RBC ghosts are excluded from the PLT count and the RBC count There are no severity levels associated with this flag Normal Abnormal PLT Scatter Cytogram PLT Scatter Cytogram 4 1 RBC Ghost area 2 Platelet area 3 RBC Fragment area The RBC Ghost value is intended for flagging and laboratory purposes only Results Flagged none Flags 6 19 6 20 Possible Causes The following list of sample related causes may not contain all conditions that could cause this flag Multiple occurrences of this flag especially for consecutive samples can indicate a system problem However isolated instances of this flag are usually sample related Sample Related Hemolysis Cryoglobulins Chylomicrons Pyropoikilocytosis Lipemia Flags Sample System Flags Flag B SUSP BC BIFR BR B NO NB B NV VB B SAT BS BTO TB CHCMCE CC Flags Summary Through the use of complex flagging algorithms laboratory personnel are alerted to suspected abnormal sample and or system conditions Sample system flags appear on the Run Screen and the Review Edit tab Whenever such flags are triggered the user should review the results and take the action recommended The following table identifies the sample system flags that could be triggered for each test selectivity The two letter codes in parentheses appear o
427. that there is a rack in the sampler B 7 B 8 ptt e This is the eject rack symbol 1 1 This is the network symbol This is the monitor symbol This symbol indicates the maximum level This is the knob symbol This is the fuse symbol This is the filter symbol This is the vacushield symbol This is the CPU symbol This symbol indicates a protective terminal This is the barcode scanner symbol B This symbol indicates that moving the component can cause injury This symbol identifies a product that contains recyclable material This symbol indicates the top of the package Ic e 8 C This symbol indicates the acceptable temperature r range for storage of the product This symbol identifies the date by which the product should be used EARR caL This is the Setpoint Calibrator symbol Warnings and Safety Information This is TESTpoint 3 in 1 Hematology Control Abnormal 1 symbol This is TESTpoint 3 in 1 Hematology Control Abnormal 2 symbol i This is the TESTpoint 3 in 1 Hematology Control Normal symbol i This is the TESTpoint High Control symbol This is the TESTpoint Low Control symbol This is the TESTpoint Normal Control symbol This is the CSF Control 1 symbol cowmoL csr 2 This is the CSF Control 2 symbol controu renic HicH This is the ADVIA RETIC High Control symbol 1
428. the three severity levels are MICRO 2 5 to 6 4 MICRO 6 5 to 10 5 gt 10 5 The MICRO value is intended for flagging and laboratory purposes only Results Flagged none Possible Causes The following list of sample related causes may not contain all conditions that could cause this flag Multiple occurrences of this flag especially for consecutive samples can indicate a system problem However isolated instances of this flag are usually sample related Sample Related System Related deficiency anemia 1 Check the RBC reagents e Hemoglobinopathies Check the RBC hydraulics 2 e Hemolytic anemias 3 Checkthe RBC gains 4 Check the laser flowcell alignment Flags Myeloperoxidase Deficiency MPO D MO Definition Sample is a weak peroxidase stainer This flag is triggered if PMN NEUT EOS gt 25 the NRBC flag was not triggered and there is a valid MN PMN valley d D 0 15 You must perform a manual differential on samples that trigger the Myeloperoxidase Deficiency flag Normal Peroxidase Staining Weak Peroxidase Staining MPO flag Perox Cytogram Perox Cytogram Baso Cytogram Baso Cytogram Because PMN NEUT Because PMN NEUT EOS is close to 0 there is no EOS is greater than 25 flag the flag is triggered By inspection the sum of the By inspection the sum of the events in the NEUT 1 and EOS events in the NEUT 1 and
429. tic chamber open V65 RBC chamber open V10 RBC baso retic vacuum shuttle chamber open V22 and V21 Hemoglobin chamber open V36 Allow alternate segments of household bleach solution and air to run through the line and the chamber until they are clean Immerse the free end of the tube into a beaker of deionized water to rinse the line and chamber Remove the tube from the beaker and close the valve Exit the Exerciser Replace the tube into the overflow bottle or if it was not an overflow tube remove it from the vent opening At the Startup window select Refresh Repeat Refresh until the background counts are acceptable 10 Run controls and verify that the results are within specifications Flowcell Wash This function flushes a clogged flowcell and is available from the Hydraulic Functions tab To wash the perox flowcell use EZ KLEEN Troubleshooting the Analyzer To wash the RBC baso retic flowcell use a 25 solution of household bleach and water To wash both flowcells at the same time use EZ KLEEN 1 Select Flowcell Wash to select it 2 Select the flowcell you want to wash by clicking an option in the Flowcell Options area e Perox Flowcell RBC Baso Retic Flowcell e Both 3 Hold a tube of EZ KLEEN perox flowcell or bleach RBC baso retic flowcell under the open tube sampler probe IMPORTANT Do not push the aspirate plate 4 Select Start to begin the flowcell wash Continue to hold the tube
430. tics assembly Troubleshooting the Analyzer 5 17 5 18 AN CAUTION To avoid getting fingerprints on the glass windows of the flowcell always hold the flowcell by the metal slides Cleaning the Flowcells off the Analyzer Step 2 Taking the Flowcell Apart 1 Unscrew the locking nut 1 at the input end of the flowcell assembly Using a twisting motion remove the CFM 2 from the flowcell Be careful not to lose the O ring seal 3 P Cleaning the Flowcells off the Analyzer Step 3 Cleaning the CFM 1 A pin vise 1 and a 1 64 inch 0 4 mm diameter drill bit 2 are supplied in the Flowcell Cleaning Kit Open the pin vise insert the drill bit approximately 1 4 inch 6 4 mm into the vise jaws then tighten the pin vise Insert the drill bit into the sheath nipple 3 Using a twisting motion carefully push the drill bit through the sheath nipple If a clog is encountered proceed slowly while continuing to twist the drill bit Repeat step 2 for the sample input nipple 4 Carefully insert the bit into the shuttle nipple 5 to a depth that just barely leaves the flutes of the bit extended beyond the end of the nipple Twist the drill bit a few times then remove it from the nipple Troubleshooting the Analyzer Cleaning the Flowcells off the Analyzer Step 4 Flushing the Flowcell and the CFM 1 Reattach the CFM to the flowcell assembly Do not overtighten the locking nut 2 To flush ea
431. til the connector is exposed then disconnect the cable 3 Connect the cable of the new valve assembly to the exposed connector on the analyzer 4 Tuck the cable back into the opening Mount the new valve using the two screws saved in step 2 5 Replace the fittings Make sure that they are threaded correctly Fingers tighten AN CAUTION Do not overtighten or you may cause damage to valve or fittings 6 Connect tubing Troubleshooting the Analyzer 5 35 To Waste Reagent UFC Perox flowcell connections To Waste Reagent RBC flowcell connections 7 Run controls Check for leaks and verify system performance 5 36 Troubleshooting the Analyzer Replacing the Open Tube Sampler Probe Materials required e Sample probe assembly PN 113 B646 01 e Scalpel or single edge razor Time Replacement 10 minutes Checkout 15 minutes Analyzer mode Off BIOHAZARD All products or objects that come in contact with human or animal body fluids should be handled before and after cleaning as if capable of transmitting infectious diseases Wear facial protection gloves and protective clothing The operator should follow the recommendations to prevent the transmission of infectious agents in health care settings as recommended for potentially infectious specimens in Protection of Laboratory Workers from Infectious Disease Transmitted by Blood Body Fluids and Tissue 2nd edition Approved Guideline
432. ting the shear faces use the shear face removal tool PN 067 1083 01 found in the spare parts kit Gently wedge the sharp edge of the tool between the two faces then remove the front shear face Cleaning the Shear Valve Step 2 Cleaning the Shear Valve Faces 1 Place the front shear face in a beaker with household bleach If the laboratory is equipped with an ultrasonic bath follow the instructions provided by the manufacturer Otherwise let the shear face soak in the beaker for 10 minutes then thoroughly rinse with water 2 To rinse the rear shear face use a wash bottle filled with water Use paper towels to catch dripping water AN CAUTION Do not wipe the shear faces with paper towels This may leave fibers on the shear faces Cleaning the Shear Valve Step 3 Putting the Shear Valve back Together AN CAUTION You may assemble the shear valve while the faces are still wet Never use paper towels gauze or cotton swabs on the shear faces These may leave fibers on the surface that can clog the precision grooves Maintaining the Analyzer 4 9 1 Shake off any excess water then install the front face on the shaft by aligning the black line on the front face with the black line and the A on the rear face The smaller loops should be at the 9 and 11 o clock positions and the large loop should be at the 5 o clock position 2 Install the rotor by inserting the drive pin 2 into the hole 1 on the right side of the
433. tional Dead Time The fraction of time that the channel is busy processing flowcell events While the RBC PIt channel is busy identifying a particular flowcell event it is unable to process any additional events that might occur By measuring this dead time the analyzer can compensate for the missed events Note that the RBC Plt channel dead time has RBC and platelet components Corrected Platelet Count The corrected platelet count is calculated using the P Count 2D R Count 2D RBC Fractional Dead Time and RBC Valid Cells P Count 2D The number of cells identified as platelets and large platelets The platelets are obtained from the PLT Scatter cytogram and the large platelets are obtained from the integrated analysis R Count 2D The count of RBCs RBC ghosts and RBC fragments that is obtained from the integrated analysis Number of red cells 2D R Count 2D x RBC Valid Cells R Count 2D P Count 2D 8 55 8 56 NRBC Analysis NRBC Method Description The ADVIA 22120 21201 22120 21201 NRBC analysis method reports NRBC counts for whole blood samples with either 200 or more nRBC uL or with at least 2 nRBCs with a WBC count of at least 3000 uL The method reports both an absolute nRBC count 10 and a percentage count ZNRBC 100 WBC It also corrects the WBC count for nRBC recalculates the WBC differential and MN and PMN The uncorrected counts 66 599 are also available and are designated by a lower case
434. tive occurrences of this condition has met the criterion specified for a stop message The autosampler halts at the same time the stop message occurs The specified stop criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Stop Criteria is reset when the Start Stop button is selected RETIC PLT Interference Error Alarm The number of consecutive occurrences of this condition has met the criterion specified for an alarm message The specified alarm criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Alarm Criteria is automatically reset RETIC PLT Interference Error Stop The number of consecutive occurrences of this condition has met the criterion specified for a stop message The autosampler halts at the same time the stop message occurs The specified stop criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Stop Criteria is reset when the Start Stop button is selected RETIC RBC Count Low Alarm The number of consecutive occurrences of this condition has met the criterion specified for an alarm message The specified alarm criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Alarm Criteria is automatically reset Status Line messages 7 85 7 86 RETIC RBC Count Low Stop
435. to 1 0 the smaller the discrepancies are Platelet X Histogram The Platelet X histogram is a 100 channel display of the high angle 5 to 15 high gain light scatter measurements that corresponds to the x axis on the PLT Scatter cytogram Platelet Y Histogram The Platelet Y histogram is a 100 channel display of the low angle 2 to 3 high gain light scatter measurements that corresponds to the y axis on the PLT Scatter cytogram Platelet VOL Histogram The Platelet VOL histogram of the two dimensional PLT analysis shows the distribution of cells by volume Volume data are obtained from the integrated analysis The histogram has a range of 0 fL to 60 fL Large platelets with volumes up to 60 fL are included in the PLT count NOTE Whenever the ratio of RBC fragments to platelets exceeds 0 25 the system uses the log normal fit calculation to determine the platelet count and the log normal fit curve appears on the Platelet Volume histogram Platelet PM Histogram The Platelet PM histogram of the two dimensional PLT analysis shows the distribution of platelets by the platelet dry mass PM Methods Methods The histogram has a range of 0 pg to 5 0 pg Platelet PC Histogram The Platelet PC histogram of the two dimensional PLT analysis shows the distribution of platelets according to the refractive index platelet component concentration PC The histogram has a range of 0 pg to 5
436. to do so or if you are starting it at a different time perform the following steps ADVIA Autoslide Slide Maker Stainer 10 13 1 2 At the Operations menu select Autoslide Control In the Autoslide Control tab select Startup and then select Start Ordering a Slide Manually You can order a slide for a blood sample that does meet the slide making criteria set in the software To manually trigger slide production for a sample use the Order Entry tab on the Data Manager menu to add the SLIDE test to the workorder You can also create a workorder for a sample that contains no tests other than SLIDE 1 2 3 4 At the Data Manager menu select Order Entry In the Order Entry tab open the existing workorder for the sample or create a new one Add SLIDE to the tests requested in the workorder and then select OK Run the sample using the autosampler The system will make the slide as ordered Staining manually smeared slides You can use the Autoslide module to stain slides that have been manually smeared away from the system 1 2 3 7 Make sure the ADVIA 2120 21201 system is not processing samples and is idle At the Operations menu select Autoslide Control In the Autoslide Control tab select the Manual STAT Door option and then select Start When the door opens insert the slide into the holder door with blood smear on the right with the frosted end up Make sure the slide is fully seated in the hol
437. ts Flagged none Possible Causes The following list of sample related causes may not contain all conditions that could cause this flag Multiple occurrences of this flag especially for consecutive samples can indicate a system problem However isolated instances of this flag are usually sample related Sample Related System Related e Sickle cell anemia 1 Check RBC reagents e deficiency anemia 2 Check RBC hydraulics e Hemolytic anemia 3 Check RBC gains e Transfusion 4 Check laser flowcell alignment Hyperchromia HYPER Definition The Hyperchromia flag is triggered if the percentage of cells with high gt 41g dL cellular hemoglobin concentration is equal to or greater than 4 0 The HYPER parameter indicates the percent of cells that have a cellular hemoglobin concentration greater than 41 g dL and is derived from the RBC HC histogram Default trigger values for the three severity levels are JHYPER 4 0 to 7 9 HY PER 8 0 to 12 0 gt 12 0 Flags Flags The HYPER value is intended for flagging and laboratory purposes only Results Flagged none Possible Causes The following list of sample related causes may not contain all conditions that could cause this flag Multiple occurrences of this flag especially for consecutive samples can indicate a system problem However isolated instances of this flag are usually sample related Sample Related
438. uated blood collection tube containing EDTA as an anticoagulant Blood samples should be refrigerated at a temperature between 2 C to 8 C if they will not be analyzed within eight 8 hours of phlebotomy If a specimen has been refrigerated allow it to equilibrate slowly to room temperature 15 C to 30 C before mixing Sample Dilution Whole blood specimens whose parameter values exceed the analytical range may be diluted with autologous plasma or isotonic saline and reassayed Sample Stability The effect of the aging of blood was studied over a 72 hour period on the ADVIA 120 Hematology System Two whole blood specimens drawn from 15 normal apparently healthy donors were assayed shortly after phlebotomy and then again at intervals of 8 24 36 48 56 and 72 hours One of the whole blood specimens from each pair was stored at room temperature while the corresponding specimen was stored at 2 C to 8 C in capped blood collection tubes that contained EDTA as the anticoagulant The results indicate that CBC parameters are stable within two 2 standard deviations within run precision of the initial recovery for the specified time interval The stability of the calculated parameters is limited to the stability of the least stable primary parameter Parameter Room Temperature Refrigerated Temperature Stability hours Stability hours WBC 103 uL 36 56 RBC 10 uL 48 72 HGB g dL 72 72 MCV fL 8 24 CH pg 36 53 CHCM g d
439. uctions in the Maintenance section replacing the Syringe Plungers Replacing the vacuum pump filter vacushield The vacuum filter traps liquid that would otherwise enter and damage the vacuum pump Replace this filter if it becomes saturated with liquid Troubleshooting the Analyzer 5 45 5 46 Materials required The words FLUID SIDE are imprinted on each filter e Flat head screwdriver Location of the filters large e Paper towels Vacushield filter PN 518 3146 01 Time Replacement 10 minutes Checkout 10 minutes Analyzer mode Off BIOHAZARD manual 1 and automatic 2 waste containers All products or objects that come in contact with human or animal body fluids should be handled before and after cleaning as if capable of transmitting infectious diseases Wear facial protection gloves and protective clothing The operator should follow the recommendations to prevent the transmission of infectious agents in health care settings as recommended for potentially infectious specimens in Protection of Laboratory Workers from Infectious Disease Transmitted by Blood Body Fluids and Tissue 2nd edition Approved Guideline 1997 Document M29 A National Committee for Clinical Laboratory Standards NCCLS This document contains complete information on user protection and it can be used as reference material for instructions on laboratory safety To replace the filter 1 Place paper towels under the filter
440. uld cause this flag There is no intention to associate the flag with specific diagnoses Flags 6 37 System Related Sample Related 1 Check perox reagents e Neonatal samples 2 Check peroxidase hydraulics and sample e Aged blood sample delivery e Malaria parasites 3 Check delivery of SHEATH RINSE e Lyse resistant RBCs 4 Check PEROX SHEATH delivery 5 Check the pressure and vacuum readings 6 Check the perox reaction chamber temperature 7 Check perox flowcell alignment 8 Check perox gains Perox Power Low PX PL PX Definition The Perox Power Low flag is triggered if the tungsten halogen light intensity in the Perox channel is less than 90 Results Flagged WBCP NEUT NEUT LYMPH LYMPH MONO EOS EOS LUC and LUC Corrective Action 1 Perform the sheath reagent check 2 Check perox lamp alignment 3 Replace the tungsten halogen lamp Perox Saturation PX SAT XS Definition The Perox Saturation flag is triggered if the events counted in the Saturation area are more than 10 of Perox signals The Saturation area of the Perox cytogram is located in channels 97 through 99 on the x axis Flags Flags Normal PX SAT Perox Cytogram Perox Cytogram 1 Saturation area The PX SAT XS flag is not triggered if WBCB and WBCP agree within specified limits WBC CE flag The WBCP count does not include events from the Saturation area Results Flagged WBCP NEUT
441. under the probe until you hear a beep and the wash block starts to move down approximately 100 seconds You can select Cancel to stop the flowcell wash It will stop at the end of the current cycle Cleaning the Flowcells on the Analyzer This method of cleaning the flowcells bypasses the shear valve and the UFC pathways e Materials required e Beaker e Household bleach Time 10 minutes Analyzer mode Ready to Run BIOHAZARD All products or objects that come in contact with human or animal body fluids should be handled before and after cleaning as if capable of transmitting infectious diseases Wear facial protection gloves and protective clothing The operator should follow the recommendations to prevent the transmission of infectious agents in health care settings as recommended for potentially infectious specimens in Protection of Laboratory Workers from Infectious Disease Transmitted by Blood Body Fluids and Tissue 2nd edition Approved Guideline 1997 Document M29 A National Committee for Clinical Laboratory Standards NCCLS This document contains complete information on user protection and it can be used as reference material for instructions on laboratory safety Troubleshooting the Analyzer 5 11 5 12 To clean the perox or RBC flowcell without removing it from the analyzer There are three tubes associated with each flowcell Typically only the sample line is cleaned The rinse and shuttle lines can be c
442. unting rate Sum of the Squared Differences Flow Uniformity 9 x Mean Cell Counting Rate The flag is triggered if this value is greater than 2 5 The BASO Rate Histogram displays the arrival rate of cells in the baso channel Normal BASO Rate Histogram BIFR BASO Rate Histogram Results Flagged WBC WBCB BASO BASO Corrective Action 1 Check baso reagents 2 Check baso hydraulics 3 Check sheath delivery A partially clogged RBC baso retic sheath filter can produce a distinctive ski slope effect on the RBC Baso and Retic flow rate histograms Replace the sheath filter RBC Rate Baso Rate Retic Rate Flags Flags Baso Noise B NO NB Definition The Baso Noise flag is triggered if the events counted in the Noise area of the Baso cytogram are more than 10 of the baso signals The B NO NB flag may cause a substitution of the WBC count The following rules determine if the WBCB or WBCP count is reported for a CBC Diff sample e WBCB is the primary WBC count e If B NO or B SAT flags are triggered the WBCP count is reported if valid Ifa B NO flag and a PX NO or PX SAT flag are triggered the count is reported with a sample system flag e WBCB is reported as the WBC count for samples with a WBC lower than 1 0 x 105 uL The Noise area 1 of the Baso cytogram is determined by cluster analysis If histogram analysis is applied the Noise area 2 is located between channe
443. upport please contact your local technical support provider or distributor Bibliography 1 White WL Erickson MM Stevens SC Practical Automation for the Clinical Laboratory St Louis MO CV Mosby Co pp 476 487 1972 2 Moss ED Automated Slide Staining in Haematology Can J Med Tech 30 5 169 1968 3 Langeron M Precis de microscopie Masson Paris 6eme ed pp 566 585 1942 Modified Wright Method Intended Use The Modified Wright method is for in vitro diagnostic use in the differential staining of blood bone marrow and body fluid smears on the ADVIA Autoslide Slide Maker Stainer Stained smears are evaluated to identify and quantify cells in whole blood and other specimens to aid clinicians in the assessment of various clinical conditions Summary and Explanation The reagent protocol for the Autoslide Slide Maker Stainer consists of a modified polychrome methylene blue eosin stain and is based on the original stain proposed by Romanowsky ADVIA Autoslide Slide Maker Stainer 10 25 The ADVIA Autoslide Slide Maker Stainer is a smart fully automated system It is capable of producing stained smears on all specimens run on the ADVIA 2120 21201 or on samples with predefined criteria i e flags or parameter threshold The Autoslide provides also a direct access port to the stainer for pre smeared slides 10 26 ADVIA Autoslide Slide Maker Stainer Staining Protocol The following is a brief descriptio
444. ure manually Run samples The system will automatically prepare slides according to the software settings You can also request a slide for a sample regardless of the results or use the Autoslide module to stain manually smeared slides If the system is not set to perform the daily shutdown cycle automatically perform the daily shutdown procedure manually Autoslide Operation Loading Reagents If reagent levels are low or the expiration date of a reagent has passed load additional reagents using the following procedure 1 2 Detach the appropriate reagent container and replace it with a new one At the Logs menu select Reagent Log and then select Autoslide Reagent Log The software opens to the Reagent Inventory window Select Reagent Installation For each new reagent enter the Reagent Volume Lot and Expiration Date IMPORTANT Both the Modified Wright and the Wright Giemsa Methods use the same reagent bottle for Stain 1 and Stain 2 In order for the reagent alarms to work properly you must determine the volumes to enter using the following calculations Stain 1 Bottle Volume Stain 2 Volume Stain 2 Bottle Volume x Dilution Ratio NOTE The Dilution Ratio is defined in the staining profile ADVIA Autoslide Slide Maker Stainer 10 11 Select OK When prompted to prime lines select Yes The system allows only one prime cycles select OK If bubbles remain in the reagent lines prime the l
445. ute and select On to restart the analyzer 3 If the problem persists call Siemens Service for assistance Autosampler Error Reset Autosampler The autosampler has experienced a software error and must be reset Corrective Action 1 At the analyzer touchpad select Off 2 Wait about 1 minute and pr select On to restart the analyzer 3 If the problem persists call Siemens Service for assistance Autosampler Extra Rack Ejected This message is for your information only If the message persists call Siemens Service for assistance Autosampler Failure Stop There has been an autosampler communication error A reset is required Corrective Action 1 Atthe analyzer touchpad select Off 2 Wait about 1 minute and select On to restart the analyzer If the problem persists call Siemens Service for assistance Status Line messages Autosampler Flash Memory Failed Reset Autosampler The autosampler flash memory failed to respond to a routine command and might be defective An autosampler reset is required Corrective Action 1 Select on the analyzer touchpad 2 Wait about 1 minute and select On to restart the analyzer 3 If the problem persists call Siemens Service for assistance Autosampler Initialization Required In diagnostic mode the analyzer sent a position command before the appropriate initialization was performed For example a position mixer command could have been sent before a mixer initialization
446. utive occurrences of this condition has met the criterion specified for an alarm message indicating that the reagent level is low The specified alarm criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria Reagent Conditions Corrective Action The alarm counter is automatically reset after reagents are replenished and the Reagent Installation window is updated Go to Logs Reagent Log Reagent Installation PEROX Irregular Flow Rate Alarm The number of consecutive occurrences of this condition has met the criterion specified for an alarm message The specified alarm criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Alarm Criteria is automatically reset PEROX Irregular Flow Rate Stop The number of cycles specified for a stop message The specified stop criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Stop Criteria is reset when the Start Stop button is selected PEROX Power Low Alarm The number of consecutive occurrences of this condition has met the criterion specified for an alarm message The specified alarm criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Alarm Criteria is automatically reset Status Line messages 7 71 PEROX Power Low Stop The number of consecutive occurrences of this
447. utomated Analysis Technicon International Congress 1972 Volume 3 Mediad Inc Tarrytown NY pp 27 32 1973 Groner W et al Peroxidase activity of human monocytes as a function of pH and fixation observed with the Hemalog D Presented at ACHE II 2nd workshop of the Automated Cytochemistry and Hematology Exchange Marlow on Thames England May 22 23 1980 Basophil Lobularity Method The Basophil Lobularity method was developed by Cremins and Orlik to provide both accurate basophil counts and a measure of cellular lobularity This method provides precise accurate and rapid recognition of basophils Cremins and Orlik discovered that basophils are particularly resistant to lysis by a combination of acid and surfactant When the EDTA anticoagulated whole blood sample is mixed with ADVIA 120 BASO reagent the red blood cells are hemolyzed and the cytoplasm is stripped from all white cells except basophils The sample is then analyzed by two angle laser light scattering detection using a laser diode The white cells are classified into three categories basophils mononuclear MN cells and polymorphonuclear PMN cells Regulatory Information REF 00739500 REF REF 02337140 01554628 Bibliography Cremins J and Orlik J Leukocyte differential method US Patent 5 518 928 1996 Reagents The following ready to use reagents are required to perform the DIFF methods and maintain the ADVIA 2120 21201 Hematology System
448. uttle line 1 the sample stream input line 2 and the sheath stream input line 3 from the CFM Allow these lines to hang freely 1 SHEATH NIPPLE 2 SAMPLE NIPPLE 3 SHUTTLE NIPPLE 4 Locate hydraulic valve 24 Unscrew the threaded fitting from the top right side of the valve To Waste Reagent UFC 5 Release the flowcell by loosening the release knob located on the right of the flowcell adjustment assembly 5 40 Troubleshooting the Analyzer Flowcell release knob 1 gt Front of analyzer 6 Hold the flowcell by the red threaded fitting located at the top of the flowcell then gently lift the flowcell out of the optics assembly PAIS CAUTION To avoid getting fingerprints on the glass windows of the flowcell always hold the flowcell by the metal slides To install the flowcell 1 Hold the flowcell by its red threaded fitting and place it gently into the optics assembly 2 Tighten the release knob to lock the flowcell into position 3 Reconnect the hydraulic lines to the CFM Reconnect the flowcell tube assembly fitting to the appropriate hydraulic valve V24 Hand tighten the connection enough to prevent leaks IMPORTANT To avoid incorrect patient data make sure that each hydraulic line is attached to the correct CFM nipple To check analyzer performance 1 Bring the analyzer to the Ready to Run mode then run a saline primer 2 Check the flowcell connections for leaks and verif
449. ve samples can indicate a system problem However isolated instances of this flag are usually sample related The following list of sample related causes may not contain all conditions that could cause this flag There is no intention to associate the flag with specific diagnoses System Related Sample Related 1 Insufficient sample e Anemia 2 Incorrect open tube sampler probe length 3 Replace the clot filter 4 Check the retic hydraulics Retic Saturation RTCSAT CS Definition The Retic Saturation flag is triggered if the events counted in the Saturation Cell area of the Retic Scatter Absorption cytogram are more than 10 of the gated cell signals The Saturated Cells area of the Retic Scatter Absorption cytogram is located in absorption channels 94 through 100 6 47 6 48 Normal Retic Scatter Abs cytogram 1 Saturation area Results Flagged RETIC CHg CHr CHCMg CHCMr CHDWr CHDWg MCVg MCVr RDWg RDWr Corrective Action Multiple occurrences of this flag especially for consecutive samples can indicate a system problem However isolated instances of this flag are usually sample related The following list of sample related causes may not contain all conditions that could cause this flag There is no intention to associate the flag with specific diagnoses System Related Sample Related 1 Check delivery of the sheath reagent e Immature reticulocytes or neonatal NRBCs 2 Chec
450. verted to electrical pulses by photodiodes After processing the following information is available BASO Rate histogram displays the arrival rate of cells in the Baso channel BASO X histogram displays the high angle light scatter information nuclear configuration for the MN mononuclear and PMN polymorphonuclear populations BASO Y histogram displays the low angle light scatter information size for the MN population BASO cytogram is formed from the paired low and high angle light scatter data Cluster analysis identifies the individual populations If cluster analysis cannot be used for a particular sample the cell populations are identified using histogram analysis BASO Rate Histogram The BASO Rate histogram shows the uniformity of the cell counting rate Methods Methods The rate histogram data consists of 50 points one taken every 200 milliseconds Each point represents the number of valid cells counted during the last 200 milliseconds BASO X Histogram The BASO X histogram displays the event distributions that correspond to the entire x axis of the BASO cytogram However it contains only those events on the y axis between the noise and basophil thresholds of the BASO cytogram This will include the MN mononuclear and PMN polymorphonuclear populations The following parameters are derived from the BASO X histogram e The mode channel MNx of the MN population on the x axis 1 The mode channe
451. view and Edit and Host Communication or you attempted to access a sample at the same time the Data Manager was attempting to access the sample Corrective Action Wait and access the sample again a few seconds later 9 End of File The Control Dictionary is empty Quality Control cannot be operated Status Line messages Corrective Action Define at least one QC file in the Control Dictionary window A Defined File in Prg par Is Not Found for Backup A file is missing that has been defined in the list of programs to be saved when running the Program backup through the End of Day functions Corrective Action Call Siemens Service for assistance Analyzer Connected The computer has connected with the analyzer Analyzer Not Connected The computer has not connected with the analyzer Possible Cause Corrective Action 1 Theanalyzeris Select On at the analyzer touchpad not on 2 Faulty or Verify that the Ethernet cable connection is secure disconnected Replace if necessary Ethernet cable from the analyzer J2 Workstation connection to the computer 3 Faulty analyzer Call Siemens Service for assistance CPU board or network interface PC board Analyzer Not Ready The analyzer cannot start sample aspiration or hydraulic cycles Possible Cause Corrective Action 1 TheSHEATH Replace the SHEATH RINSE reagent Status Line messages 7 7 RINSE reagent container is empty 2 The waste container is full
452. volume marker 3 28 g dL HC marker 5 41 g dL HC marker Markers organize the cytogram into 9 distinct areas of red blood cell morphology On the x axis hemoglobin concentration markers are set at 28 g dL 3 and 41 g dL 4 Red blood cells with a hemoglobin concentration less than 28 g dL are hypochromic while cells with a hemoglobin concentration greater than 41 g dL are hyperchromic On the y axis RBC volume markers are set at 60 fL 1 and 2120 21201 fL 2 Red blood cells with a volume less than 60 fL are microcytic while cells with a volume greater than 2120 21201 fL are macrocytic RBC Matrix HC 28 HC 28 41 gt 41 0 0 0 96 The RBC Matrix provides the cell counts and percentages for the nine regions of the RBC V HC cytogram NOTE Analysis of the RBC Volume and RBC HC histograms provides a quantitative analysis of the red blood cell populations Additional qualitative information concerning these red blood cell populations can be gained from simultaneous analysis of volume and hemoglobin concentration using the RBC V HC cytogram 8 45 8 46 Since the histogram analysis uses calibration factors that are not applied to the RBC V HC cytogram there can be a discrepancy between the RBC matrix values and the corresponding Micro Macro Hypo and Hyper values obtained from the histograms based on the value of the calibration factors The closer the MCV and calibration factors
453. w of the Exerciser tab open V16 and V17 and then push the syringe to push EZ KLEEN through the shuttle pathway to the VSC chamber Repeat with deionized water and then close V16 and V17 13 Refill the syringe with EZ KLEEN 14 At the Valves window of the Exerciser tab open V5 and V6 Remove the cap from the Perox chamber 9 and then push the syringe to fill the chamber When the chamber is full open V7 to drain it Close V7 Repeat with deionized water and then close V5 V6 and V7 15 Remove syringe 4 from the white fitting 16 Reattach the line to the fitting on V24 3 17 Select the Analyzer Status tab to exit the Exerciser 18 Open the Hydraulic Functions tab and then perform one System Wash cycle 19 Run controls to verify system performance Backflushing the RBC baso retic Flowcell and Shuttle and Reaction Chambers Materials required e Flowcell cleaning kit PN 113 B711 01 e EZ KLEENBeaker e Deionized water Analyzer mode Ready to Run BIOHAZARD All products or objects that come in contact with human or animal body fluids should be handled before and after cleaning as if capable of transmitting infectious diseases Wear facial protection gloves and protective clothing The operator should follow the recommendations to prevent the transmission of infectious agents in health care settings as recommended for potentially infectious specimens in Protection of Laboratory Workers from Infectious Disease Tran
454. waste was collected from an ADVIA 2120 21201 Hematology System operating in three analytical modes CBC CBC diff and CBC diff retic Using the autosampler 300 CBC analytical cycles were run on fresh whole blood samples followed by the daily wash cycle The waste was thoroughly mixed and samples were sent for analysis The process was repeated for both the CBC diff and CBC diff retic analytical modes All analysis with the exception of dimethyl formamide DMF was done by Tel Labs Blessington Ireland NOTE For waste management purposes the system generates approximately 23 mL of waste during a typical CBC diff retic cycle including SHEATH RINSE Concentrations are mg L ppm unless otherwise noted Regulatory Information lt indicates that the concentration is below the limit of detection indicates a calculated concentration Analyte CBC CBC Diff CBC Diff Retic pH 8 5 77 7 4 Phosphate as 460 530 500 Chloride 5445 4268 4273 Barium lt 0 01 lt 0 01 lt 0 01 Silver lt 0 01 lt 0 01 lt 0 01 Arsenic lt 0 01 lt 0 01 lt 0 01 Selenium lt 0 01 lt 0 01 lt 0 01 Mercury lt 0 001 lt 0 001 lt 0 001 Nickel lt 0 01 lt 0 01 lt 0 01 Chromium lt 0 01 lt 0 01 lt 0 01 Zinc 0 05 0 05 0 09 Cadmium lt 0 005 lt 0 005 lt 0 005 Copper 0 02 0 01 0 01 Lead lt 0 01 lt 0 01 lt 0 01 TOC g dL 0 2 2 1 1 6 Cyanide 2 38 0 33 lt 0 05 Formaldehyde 0 896 720 adsorbable organic 0 59 1 97 2 32 halide purgeable organic 0 52
455. xpired e Stain open for extended period e Dirty stainer e Room temperature too high e Humidity too high e Slide not dry before examination Reagents and Supplies For in vitro diagnostic use Color Bluish pink Reddish orange large and spherical in shape Purplish blue can have reddish tone Faint pink Distinct deep purplish blue to purplish black Distinct light blue Small blue to violet blue tend to aggregate in center Reddish to reddish pink in color intensity of stain is less in central area where cell is thinnest Dark purple Pale Blue to pale blue gray Dark blue to reddish blue Purplish red Reagents are ready to use and require no preparation REF Contents 08096536 Wright Giemsa 0 Stain STN 00097185 Japan Symbols Amount 4 x 3 8L 1 gallon ADVIA Autoslide Slide Maker Stainer 08097532 Wright Giemsa pup 4x3 8L 1 gallon Buffer 08096412 Methanol CHOH 3 81 1 gallon 00096669 Japan 06837687 ADVIA Autoslide 10L RNS Rinse Wright Giemsa Stain Methanol gt 99 e Polychrome methylene blue eosin stain Toxic Toxic danger of very serious irreversible effects through inhalation in contact with skin and if swallowed Keep container tightly closed Avoid contact with skin Wear suitable protective clothing and R39 23 24 25 gloves In case of accident or if you feel unwell seek medical advice S7 24 immediately show the label where possible Contains m
456. y AN WARNING To avoid possible injury that may occur from laser radiation do not remove the laser safety shield You must not remove the flowcell if the laser safety shield is not in place on the laser optics assembly LASER SAFETY SHIELD DO NOT REMOVE Troubleshooting the Analyzer A LASER WARNING To avoid damage to the eyes never look directly at the laser beam or at its reflection from a shiny surface All field service procedures must be followed precisely Only Siemens trained field service personnel should perform procedures related to laser assemblies For more safety information and laser specifications refer to Safety Information Protecting yourself from lasers 1 Make sure that the analyzer is in the Standby mode 2 Open the optics cover The RBC flowcell is on the left Perox flowcell 1 RBC flowcell 2 3 Disconnect the shuttle line 1 the sample stream input line 2 and the sheath stream input line 3 from the CFM Allow these lines to hang freely 1 SHUTTLE NIPPLE 2 SAMPLE NIPPLE 3 SHEATH NIPPLE 1 3 2 4 Locate hydraulic valve 23 Unscrew the threaded fitting from the top left hand side of the valve Troubleshooting the Analyzer 5 43 5 Loosen the captive flowcell release screw then remove the flowcell Flowcell 1 flowcell release screw 2 6 Hold the flowcell by the red threaded fitting when lifting the flowcell out of the optics assembly AY AN C
457. y Check for pinched air lines supplying needle cylinder On the analyzer touchpad select Off a Wait about minute and select On to restart the analyzer e If the problem persists call Siemens Service for assistance 3 Needle is Replace needle bent 4 Needle sensor Call Siemens Service for assistance failed Autosampler Needle Failed to Retract Reset Autosampler The autosampler needle failed to retract properly Possible Cause Corrective Action 1 Critical a Open the autosampler access door Sampler b Close the autosampler access door The autosampler Status Line messages 7 29 Error will reset Ifthe problem persists select Off at the analyzer touchpad d Wait about minute and select On to restart the analyzer e Ifthe problem persists call Siemens Service for assistance 2 40 PSI line is Check pressure and adjust if necessary out of range b Check for pinched air lines supplying needle cylinder At the analyzer touchpad select Off Wait about minute and select On to restart the analyzer e Ifthe problem persists call Siemens Service for assistance 3 Needle is Replace needle bent 4 Needle sensor Call Siemens Service for assistance failed Autosampler Needle Jammed The needle failed to extend or retract during sample aspiration Possible Cause Corrective Action 1 40PSI line out Check pressure and adjust if necessary of range b Check for pinched a
458. y each disk write a sequence number on the disk paper label only To format and label a disk select the Utilities menu select Backup Restore and then select Format Logging Off 1 Atthe Operations menu select Log On Off 2 Select Log Off 3 11 3 12 Daily Routine Maintaining the Analyzer SCHEDULE 2 SYSTEM 2 2 12 3 CLEANING THE CENTERING COLLAR eee 3 CLEANING THE SHEAR VALVE AND ASPIRATION PATHWAYS IN THE LEC 6 CLEANING THE SHEAR VALVE e eee eee ee ee 0 0 61010 000046000000 00000 00000000 7 CLEANING THE SHEAR VALVE STEP 1 TAKING THE SHEAR VALVE FACES APART 8 CLEANING THE SHEAR VALVE STEP 2 CLEANING THE SHEAR V ALVE FACES 9 CLEANING THE SHEAR VALVE STEP 3 PUTTING THE SHEAR VALVE BACK TOGETHER 9 CLEANING THE SHEAR VALVE STEP 4 CHECKING ANALYZER PERFORMANCE 10 INSPECTING AND CLEANING THE SYRINGE PLUNGERS PN 067 506 01 PDnn 10 REPLACING THE SAMPLER 8 2 13 REPLACING THE SHEATH FILTENRS eese 15 REPLACING THE 50 OR 1000 uL SYRINGE PLUNGERS PN 067 506 01 AND jnn MM 16 CLEANING THE AIR CIRCULATION FILTER eese
459. y saline background on the Startup tab 3 Atthe Procedures menu select the Align Optics tab 4 Select the Info button for help 5 Atthe Logs menu select Cal Gain Logs and check gain factors Adjust gains if necessary Troubleshooting the Analyzer 5 41 5 42 6 Runa whole blood primer and then run controls to verify analyzer performance 7 Ifthe control results are acceptable to the laboratory no additional action is required and normal operation can be resumed Replacing the RBC baso retic flowcell Before you remove the RBC baso retic flowcell read all laser safety precautions Time Installation 15 minutes Checkout 15 minutes Analyzer mode Standby BIOHAZARD All products or objects that come in contact with human or animal body fluids should be handled before and after cleaning as if capable of transmitting infectious diseases Wear facial protection gloves and protective clothing The operator should follow the recommendations to prevent the transmission of infectious agents in health care settings as recommended for potentially infectious specimens in Protection of Laboratory Workers from Infectious Disease Transmitted by Blood Body Fluids and Tissue 2nd edition Approved Guideline 1997 Document M29 A National Committee for Clinical Laboratory Standards NCCLS This document contains complete information on user protection and it can be used as reference material for instructions on laboratory safet
460. ystem Preparation Failed An error occurred during the initial system preparation phase Possible Cause Corrective Action 1 Software Follow these steps to exit the ADVIA 2120 21201 communication software and then restart failure a Select Shut Down ADVIA in the Log On Off window b Select CTRL ALT DELETE and log back onto the system to restart the software 2 Hardware error Refer to associated hardware error message for appropriate corrective action 3 Faulty CPU Call Siemens Service for assistance board Status Line messages System Preparation in Progress When the ADVIA 2120 2120i is first powered on or the software is restarted the analyzer and the computer go through a preparation process which includes the following e Software initialization e Internal diagnostic checks e Priming of reagent lines e Startup including a background verification cycle System Preparation Not Complete Corrective Action a Resetthe analyzer by selecting Utilities Exerciser Indicators Analyzer Reset b After about 1 minute if the status line does not display Ready to Run and the green ready to aspirate light is still off follow these steps to exit the ADVIA 2120 21201 software turn off the analyzer and then restart i Select Shut Down ADVIA at the Log On Off window ii Select Off at the analyzer touchpad iii Select CTRL ALT DELETE and log back onto the system to restart the software iv Restart the analyzer by selecting On a
461. ystems be monitored using the ADVIA TESTpoint Hematology Controls Low Normal and High and ADVIA TESTpoint Reticulocyte Control Low and High Please refer to page 5 for product descriptions Control materials should be assayed at the beginning of each shift or at some other interval chosen by the laboratory after a reagent lot number change and after replacement of any part or component of the analytical module that may affect analytical performance The laboratory must evaluate all control results before reporting patient results If control results fail to meet the laboratory s established criteria for acceptability all patient test results obtained in the unacceptable test run must be evaluated to determine if patient test results were adversely affected The laboratory should take and document appropriate corrective actions which may include recalibration and reassaying of patient samples before reporting patient results System Method Information Gain Adjustment The gain adjustment procedure is used to adjust the amplification of signals in a channel to properly position the cell signatures within a cytogram Materials Required for Adjusting Gains e Whole Blood e 120 OPTIPOINT Regulatory Information 9 15 9 16 REF Product Contents Amount mL Number 04408568 T03 3682 54 4x 6 0 mL T03 3682 01 OPTIpoint 6 0 mL ADVIA 120 SETpoint Calibrator REF Product Symbol Contents Amount Number
462. yzer by selecting On at the analyzer touchpad Analyzer Computer Not Connected Communications between the analyzer and the computer have been interrupted 7 8 Status Line messages Possible Cause Corrective Action 1 Power failure Select Off on the analyzer touchpad and verify that the at the analyzer power plug is connected and secure Reconnect if necessary and select On at the analyzer touchpad 2 Faulty or Verify that the Ethernet cable connection is secure disconnected Replace if necessary Ethernet cable from the analyzer J2 Workstation connection to the computer 3 The computer Follow these steps to exit the ADVIA 2120 21201 networking software turn off the analyzer and then restart configuration a Select Shut Down ADVIA in the Log On Off has been window corrupted b Select Off at the analyzer touchpad Select CTRL ALT DELETE and log back onto the system to restart the software d Restart the analyzer by selecting On at the analyzer touchpad e Ifthe problem persists call Siemens Service for assistance Anisocytosis Alarm The number of consecutive occurrences of this condition has met the criterion specified for an alarm message The specified alarm criterion is user definable in the Customize Menu System Setup Alarm Stop Criteria The counter associated with the Alarm Criteria is automatically reset Anisocytosis Stop The number of consecutive occurrences of this condition has met the

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