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Operator`s Manual - Drucker Diagnostics

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1. J 10 5 g eL 9 2 11 4 29 9 g L 23 7 30 8 17 8 xi0 L 15 6 19 5 59 136 x1C 7 4 5 2 QBC Controls QBC Hematology Control p n 424304 is available for performance monitoring of the Autoread Plus system The control kit is shipped at regular intervals and contains two levels of control material along with instructions for preparing and testing control tubes and an assay sheet showing expected results Good laboratory practice suggests that controls be run to assist in monitoring the performance of the total test system For users in the United States the Clinical Laboratory Improvement Amendments CLIA requires that controls be used for each day of patient testing For more information on CLIA requirements please consult www phppo cdc gov clia regs All types of QBC tubes AccuTubes and standard can be tested with the control material To test QBC AccuTubes use the MODE key to program the analyzer to the Control mode shown opposite then insert the control filled tube Review the instructions sent with the control to determine which analyzer mode should be used for testing other QBC tube types An eight scan measurement and analysis procedure occurs identical to the display routine for QBC blood tubes in Section 4 2 2 Control results appear on the display panel and printout Refer to the instructions and assay values supplied with the control kit for identification of
2. 4 MESSAGES d For VALUES SHORT HDR Press NEXT MESSAGES d For VALUES LONG HDR Press NEXT MESSAGES d For NO PRINTOUT Press NEXT MESSAGES d For TEST VALUES only Press NEXT d MESSAGES d Print full page YES 4 NO PRESS 4 PRESS MESSAGES MESSAGES K Page Printout Label Printout Press NEXT Press NEXT AVAILABLE WITH me d TEST VALUES ONLY Autoread Plus Set Print Format 2 5 Setting Baud Rate The analyzer is prepared for computer interfacing by first setting the baud or data transmission rate via the SET BAUD RATE option function See OPTIONS FUNCTIONS in Section 4 6 Once this latter function has been entered baud rates of 1200 2400 9600 38 400 and 115 000 are selectable 2 6 CALIBRATION CHECK ROD 2 6 1 Description A calibration check rod is supplied with the system for daily performance verification of the Autoread Plus analyzer The calibration check rod Figure 2 7 consists of a specially coded metal carrier rod The carrier holds a plastic coated label with an alternating pattern of black and fluorescent orange bars 2 6 2 Use The calibration check rod can be inserted in the analyzer in either direction since the instrument automatically detects and adjusts for the reading direction As shown in the display opposite a separate mode is provided for testing the calibration check rod Upon installation and daily before assaying patient sample
3. D 1
4. 10 3 2 9 3 8 5 0 3 9 9 0 GRANS 65 2 02 73 1 41 71 2 86 66 1 43 68 1 85 GRANS 70 4 3 70 1 1 66 2 7 66 2 7 67 1 7 L M 2 5 5 86 1 8 3 69 3 3 6 49 5 6 8 09 1 7 9 02 L M 2 5 7 4 3 5 6 1 5 4 7 0 9 4 4 2 L M 35 3 78 27 3 85 29 6 96 34 2 77 32 L M 30 10 2 30 2 6 34 5 2 34 5 3 33 3 5 A 2 4 2 Accuracy Performance of the Autoread Plus analyzer with QBC standard tubes is typical of the family of QBC hematology analyzers exhibiting the performance shown in Table A 2 2 below Table A 2 2 CORRELATION DATA QBC SYSTEM HCT HB PLT AND WBC Range of gt Specimen Correlation Parameter n Reference W Slope Intercept Reference Method Coefficient p Values Venous F 200 16 5 56 6 0 9884 0 9952 0 3655 Microhematocrit 3 HCT 96 I Capillary 100 34 0 50 7 0 9450 1 0000 0 0027 Microhematocrit 13 Venous yanmeth moglobirit4 206 7 0 17 8 0 9905 1 0007 0 0477 y I HB g dl Capillary 112 10 1 18 2 0 9590 0 9888 0 05077 Cyanmethemoglobin 14 Venous 492 9 733 0 9056 0 9744 8 2440 See Note 1 V PLT Se 101 2 869 0 9326 1 0260 0 0583 x 109 l Phase Microscopy Capillary 99 146 383 0 7129 0 9903 0 1430 UF 100 Venous 385 1 8 32 0 0 9825 0 9613 0 5059 WBC See Note 2 x 109 l ill Gapillary 100 3 9 12 7 0 8652 0 9870 0 0592 Coul
5. Set Language Select Ve PRESS OR e MESSAGES TO SCROLL For English Press NEXT MESSAGES i Pentru Romani Apasati NEXT MESSAGES i Para Portugu s Aperte NEXT MESSAGES i Polski Nacisn NEXT MESSAGES d Fur Deutsch NEXT eingeben MESSAGES i Para espa ol Pulsar NEXT MESSAGES i MESSAGES i Per Italiano premere NEXT PRESS NEXT AT DESIRED LANGUAGE 2 4 INITIAL ADJUSTMENTS TO ANALYZER continued 2 4 3 Setting Calendar Clock The Autoread Plus analyzer incorporates a battery powered electronic clock that records the date andtime on each printed test report Whenever the Power switch is turned on the analyzer is automatically sequenced through the start up program described in Section 4 1 Upon satisfactory completion of the SYSTEM CHECK portion of start up the instrument momentarily displays the date and time currently set in the clock Note Depending on the programmed format of time 12 or 24 hours the date time will appear as shown in one of the displays opposite If the date time or hourly format require resetting press the MODE key to advance the display to the OPTIONS MODE then press the 4 key to obtain the SET DATE amp TIME option Reset the clock to the correct date and local time by following the directions on the message displays opposite At each step where indicated use the 4 or keys to adjust the numerical value to its corr
6. ePuncture finger or heel with sterile lancet wipe away first drop of blood and immediately collect next drop or two directly in QBC AccuTube or capillary blood tube Specimens taken after first several drops may yield lower platelet counts since platelets may adhere to wound site or may aggregate in the drop of blood 5 2 e Slight pressure can be applied some distance from finger puncture Avoid squeezing puncture area to prevent diluting blood with tissue fluid 5 2 2 Anticoagulants QBC AccuTube and QBC capillary blood tubes are internally coated with sodium heparin and di potassium EDTA and require no additional anticoagulants 5 2 3 Interfering Substances See Paragraph 5 1 8 under Venous Blood Interfering substances information for all other QBC tube types can be found in Appendix A 1 5 2 4 Stability of QBC Capillary Tubes Filled QBC AccuTubes and other QBC capillary blood tubes should be mixed and centrifuged promptly after blood collection 6 1 MATERIALS PROVIDED The Autoread Plus Hematology System consists of the following instruments and accessories with which to perform hematology tests eQBC Autoread Plus Analyzer with software cartridge e QBC Power Pack QBC Capillary Centrifuge e Printer Calibration Check Rod Workstation e Forceps QBC Pipetter with AccuTube Spacer 6 2 MATERIALS REQUIRED BUT NOT PROVIDED eQBC AccuTubes 100 Tests eL int free tissue 423406 6 3 HEMATOLOGY TEST
7. 2 7 36 7 24 22 4 31 11 16 09 4 75 22 6 15 11 x 109 L 3 7 69 8 11 24 2 78 12 15 51 5 47 24 3 83 12 1 6 15 9 30 28 5 76 14 10 29 8 28 28 0 14 GRAN x 109 L 2 4 67 8 58 22 7 33 11 8 01 3 66 22 4 08 11 3 4 94 8 39 24 3 61 12 8 27 4 73 24 3 18 12 1 3 40 12 05 28 8 95 14 8 77 11 32 28 0 14 LYMPH MONO 2 2 68 7 60 22 8 21 11 8 07 6 53 22 8 71 1 4 x 109 L 3 2 74 11 86 24 4 13 12 7 24 9 09 24 5 49 12 Key to QBC Control Precision Table Intra run precision variability between duplicate tubes during the same run Inter run precision variability between two runs per day over multiple days df degrees of freedom 0 negative estimate variance was negative Site 1 amp Site 2 POLs Site 3 BDPCD 7 4 2 Accuracy The performance of AccuTubes with the QBC Autoread Plus system is based on data from venous blood samples collected in Vacutainer brand collec tion tubes containing KaEDTA anticoagulant Venous blood samples provide a more stable test system than capillary blood for comparing results from multiple methods While skin puncture samples provide clin ically relevant results they are subject to more varia tion due to the nature of the sampling technique Parameter Coirelati n Slope Intercept Coefficient Hematocrit 0 993 0 960 2 587 Hemoglobin g dL 0 994 0 992 0 050 Platelet x 109 L 0 931 0 926 16 463 WBC x 109 L 0 978 1 045 0 239 Granulocyte x 109 L 0 985 1 071 0 458 Lymph Mono x 109 L 0
8. EES Figure 3 7 Transport Mechanism 3 3 3 1 4 Transport Mechanism continued Inserting a QBC tube and closing the platform door initiates the following start sequence eAn optical sensor detects that the tube is inserted thereby activating a switch eAs the door is shut an actuating bar on the underside of the door closes a mechanical switch to enable the transport start sequence eA motor moves the transport carriage with collet to clamp the unsealed end of the tube firmly in position e Once the tube is colleted the transport carriage moves away from the loading platform into the optics chamber The test sequence for a patient specimen consists of three phases e identification scanning Measurement scanning and Data analysis Initially the tube is subjected to forward and reverse check scans while the optical sensors determine the type of QBC tube float dimensions and plasma volume NOTE Every scan regardless of the test mode is accompanied by a muted whirring sound caused by rapid acceleration of the motor and tube transport mechanism this whirring sound is normal The tube then undergoes a series of rapid measurement scans as described in paragraph 3 1 7 When scanning is complete the specimen tube is returned to the loading platform while the analysis and data reduction phase continues Total test time is between 1 and 3 minutes depending on the software version and the test being performed
9. 109 L High Lymph Mono Count Display flashes 99 9 when Lymph Mono count is over 99 9 x 109 L e High Platelet Count Display flashes 999 when Platelet count is over 999 x 109 L See Appendix A 2 for out of range points for other QBC tube types 4 3 2 Special HB MCHC Conditions No HB and MCHC values will appear if any of the conditions listed in Table 4 2 occur In such cases the examination of a peripheral blood smear is recommended to determine the nature of the red cell abnormality 4 6 Table 4 1 Out of Range Points for Flashing Test Values AccuTube HCT 1596 or 6596 PLT 20 or 999 WBC 1 6 or 99 9 GRANS 0 8 or 70 LYMPH MONOS 0 8 or 99 9 109 L Table 4 2 HB MCHC No Value Conditions HCT lt 1596 or gt 6596 HB lt 5 g dL or gt 20 g dL MCHC lt 25 g dL or gt 37 3 g dL 4 4 ERROR MESSAGES When the analyzer detects an error or irregular condition a message or code is displayed to identify the problem A list of error messages is provided in Table 4 3 The error messages are categorized by the mode or operating sequence in which they can occur Corrective action is in some cases obvious i e wrong tube was inserted for others service must be requested to repair a failed component still others e g during scanning require a more detailed analysis 4 5 SYSTEM CHECKS 4 5 1 Calibration Check Rod The calibration check rod is designed to veri
10. 957 0 826 0 614 Products of Coulter Electronics Hialeah FL The hematocrit results shown above reflect the calibration methods of the Coulter analyzers used in the correlation study The QBC Autoread Plus software has been calibrated to match the international reference standard for microhematocrit Correlation Parameter np Slope Coefficient Hematocrit 96 0 996 1 003 Intercept 0 111 Approximately 290 blood samples were analyzed on both the QBC Autoread Plus System with AccuTubes and Coulter Hematology analyzers S Plus S Plus IV STKS STKR The correlation coefficients for the WBC Gran L M HCT and HB parameters were 0 95 or greater The correlation coefficient for the PLT parameter was 0 93 Complete statistical results are presented below Products of Coulter Electronics Hialeah FL QBC Mean Cell Counter Range of E Mean Values Bamnnies 35 7 34 5 13 8 60 2 294 11 7 11 7 5 5 19 0 293 267 271 29 843 278 10 8 10 5 2 1 81 5 282 7 9 7 8 0 7 71 0 277 2 9 2 8 0 2 76 9 280 MHCT technology 13 The data shown in the table below were obtained by comparing the QBC Autoread Plus AccuTube results against the microhematocrit reference method Cell Counter Range of Number QBC Mean P g of Mean Values Samples 34 4 34 4 17 5 53 1 120 Wintrobe M M 1981 Clinical Hematology 8th Ed Lea amp Febiger Phila PA Wintrobe M M 1933 Macroscopic Examination of the Blood American Journ
11. AUTOREAD PLUS Hematology Systems through the following procedure 1 Using the appropriate test mode process the QBC tube and allow it to print the standard QBC report 2 When the standard QBC report is finished printing leave the QBC tube in the instrument with the results on the display screen Depress the MODE and DOWN ARROW KEY at the same time in order to initiate the printing of the Diagnostic Scan note depress the keys for 1 2 seconds and then release For best results during faxing Diagnostic Scan printouts should be on an 8 1 2 x 11 sheet of plain white paper 3 The QBC AUTOREAD A QBC AUTOREAD PLUS will print a second page containing three 3 boxes with graphs followed by several rows of numbers The QBC AUTOREAD amp QBC AUTOREAD PLUS will display Now Printing in the message window as the information is being printed 4 Fax the Diagnostic Scan information to QBC Diagnostics Technical Services at 1 814 692 7662 Prior to faxing the scans please call the QBC Diagnostics Inc Technical Services Department at 1 866 265 1486 toll free or 1 814 692 7661 Inform one of the Technical Specialists that you are faxing Diagnostic Scan information for review 5 Please provide the following information with the fax Lot Number and Expiration Dates and type of QBC tube being used QBC Model Number and Serial Number Model and Serial Numbers for the QBC AUTOREAD QBC AUTOREAD PLUS are located on the bottom of the unit Ad
12. An AccuTube spacer must be added to the pipetter to adjust the fill volume to 70 uL when filling QBC AccuTubes Instructions for use are provided in Section 4 8 3 7 SPECIFICATIONS See Appendix B for specifications on the QBC Autoread Plus System 3 8 Figure 3 16 QBC Workstation and Venous Blood Pipetter 4 1 STARTING ANALYZER 4 1 1 Power On Self Check Actuating the POWER switch on the back of the analyzer causes the instrument to test its internal electronics optics and mechanical systems including the segmented LCD displays NOTE Before turning power on be sure the loading platform is empty tube removed and the platform door is closed If the door is left open the self check sequence will stop and a display message to close the door will appear During the LCD display check Figure 4 1 verify that all segments in all the numeral 8 s are illuminated and that decimal points are present in all readouts except GRANS LYMPH MONO and PLT Request service in the event of a defective display Status messages are automatically displayed during the startup sequence as shown opposite If the SYSTEM CHECK phase fails an alert message will appear that flags an error condition See Table 4 3 for a list of startup error flags 4 1 Section 4 Operating Procedures HEMOGLOBIN g dL LYMPH IMONO Figure 4 1 Momentary Displays Check i Software Version amp Issue Date Y Autoread Plus
13. Fill Tube venous Step 1 Fill Tube capillary Step 2 Rock the AccuTube to Mix Step 2 Rock 5 Times Note Do not allow the blood to touch the AccuTube rubber stopper while performing this step If blood stops moving loosen or remove the stopper and finish mixing then re insert the stopper Hold the AccuTube in the center Rock the AccuTube back and forth at least 5 times Move blood end to end to mix well with orange coating Step 3 Seat the Stopper Step 3 Turn the AccuTube upright Hold the AccuTube Seat Stopper near the stopper end Seat the stopper by pressing down firmly on a hard surface At this point the blood can touch the stopper Step 4 Insert the Float Note Do not touch the floats with your fingers Slide the open end of the AccuTube over a float until the float is partially inserted Gently lift the AccuTube up and out of the SoftGrip Push float against the back of the package to fully insert Step 4 Insert Float 6 3 Step 5 Centrifuge the AccuTube Open the centrifuge lid and remove the metal cover Hold the AccuTube so the rubber stopper is toward the outside edge of the rotor Place the AccuTube in the centrifuge Balance the rotor by placing an AccuTube balance tube may be empty or full in the slot opposite the patient AccuTube Place the metal cover over the rotor and screw in place until finger tight DO NOT OVER TIGHTEN Close the lid and press ON OFF button The
14. Printouts sresruk aaa 4 4 4244 Assaying Additional e 4 5 4 3 TESTALER E 4 6 43 1 Flashing Values and East sussies 4 6 4 3 2 Special HB MCHC Conditions EE 4 6 4 4 ERROR MESSAGE esoe 4 7 4 5 SYSTEM CHECKS EE 4 7 4 5 1 Calibration Check FOG E 4 7 452 QBG COMUG EE 4 8 45 3 OBC ee 4 9 4 6 OPTION FUING s Ea 4 10 4 7 QBC CAPILLARY CENTRIFUGE sapete bti ni Ge dh i ege 4 10 4 8 DIAGNOSTIC SCANS i u uu ineine iaeoa aeaa ATEN uE KEETE KETASAN EERE EERDE ESti 4 11 4 9 QBC PIPE TER T 4 14 4 10 PRECAUTIONS AND HAZARDS esu gu axsxasuasennsnsgueeuieuih usteet deeg 4 15 Section 5 SPECIMEN COLLECTION AND PREPARATION FOR TESTING 5 VENOUS BLOOD FOR HEMATOLOGY u mim tti a iaieiiea 5 1 51 1 Colection iT 5 1 SNR MEN ice irg ce 5 1 5 1 3 Interfering Substances QBC AccuTubes 5 1 5 1 4 Specimen Storage and Stability QBC AccuTubes 5 2 5 2 CAPILLARY BLOOD FOR HEMATOLOQY a 5 2 5 21 Collection Procedures ss uuu u qusc ua pua rb ai ux RUM MIU Ka Rd 5 2 EE OA EE 5 2 5 2 3 Interfering Ee 5 2 5 24 Stability of OBC Capillary Tubes 5 2 Section 6 TEST PROCEDURES 6 1 MATERIALS PROVIDED i eenegen 6 1 6 2 MATERIALS REQUIRED BUT NOT PROVIDED 6 1 6 3 HEMAT
15. QBC Capillary Tube packaging Step 1 Fill and Mix Tube From end of capillary blood tube nearest two black lines fill tube with finger puncture blood to any level between black lines A With lint free tissue wipe off any blood on outside of tube being careful not to draw specimen from tip of the tube Blood may be from plantar surface of heel in infants less than one year old Keeping tube nearly horizontal roll tube between fingers several times to mix blood with anticoagulant coating B A 1 4 WARNING Bi D D l l 8 Blood specimens may contain the Hepatitis B Virus HBV Hepatitis C Virus HCV Human Immunodeficiency Virus HIV or other disease causing agents Handle all patient specimens as potential biohazards capable of transmitting infection Wear appropriate personal protective equipment including gloves when collecting and processing blood Turn tube around and tilt allowing blood to flow to opposite end of tube C Roll tube between fingers at least 10 times or for at least 5 seconds to mix blood with potassium oxalate and acridine orange coating Promptly proceed to Step 2 Step 2 Seal Tube and Insert Float With 424241 Tray Place gloved index finger over end of tube nearest fill lines and insert distal end into closure in tube tray D1 With 424238 Box Place gloved index finger over end of tube nearest fill lines Remove closure from test tray well and press distal end of tube on
16. SYSTEM PERFORMANCE WITH QBC VENOUS AND CAPILLARY TUBES TEST RESUL IS u A 2 1 AS Mee RTE Format EE A 2 1 A 2 1 2 Operating Ranges EE A 2 1 TEST LIMITATIONS ege EE A 2 2 Te RT A 2 2 SPECIFIC PERFORMANCE CHARACTERISTICS A 2 3 A 241 Pr GiISI n P A 2 3 dek elc sm A 2 4 Contents continued APPENDIX B SERVICE MAINTENANCE AND SPECIFICATIONS B 1 INTRODUC TON E B 1 B 2 SERVICE AND MAINTENANCE crire i aa B 1 B 2 1 Autoread Plus Analy Zen assisia qasaq a B 1 B 2 2 Power Packu aa UT B 1 B 2 3 OBC Capillary e ue sacaciasccccevetessntsdeusiaslenageadecteatacceisauaniexaedseass B 1 B24 MR ADS RE T B 1 B 3 sized ue TE B 2 B 3 1 Autoread Plus Anahyzer nnne B 2 B 3 2 POWER uec B 2 B33 GBC Capillary ee ad e E B 2 APPENDIX C LIST OF PARTS QBC AUTOREAD PLUS SYSTEM C 1 APPENDIX D WARRANTY J a D 1 1 1 INTENDED USE The QBC Autoread Plus System Figure 1 1 provides a 9 parameter hematology profile of centrifuged venous or capillary blood The QBC Autoread Plus System provides a diagnostic hematology profile of the following quantitative values from a single tube of blood Hematocrit e Hemoglobin e Mean Corpuscular Hemoglobin Concentration e Platelet Count eWhite Blood Cell Count e Granulocyte Count 96 a
17. Y Autoread Plus System Check N Date amp Time 5 Second Display L CBC MODE Insert QBC Tube m o gt 0 m n lt m Re R gt O m Ro m Re R gt O m Ro m m Re Re o o 5 m Im Ro Ro 4 1 2 Mode Selection Upon completing the startup sequence the Autoread Plus analyzer defaults or autoprograms to the hematology testing mode i e CBC MODE see Figure 4 2 Depending on the desired operation press the MODE key to access any one of the following modes e CBC MODE Insert QBC Tube e CAL CHECK MODE Insert Calibration Rod e CONTROL MODE for hematology control Insert QBC Tube e OPTIONS MODE Select 4 to Set Date and Time Set Print Format Cartridge Type and Set Baud Rate 4 1 3 Pre Test Performance Check Each day before running patient specimens verify instrument performance by assaying the calibration check rod Press the MODE key to select the CAL CHECK MODE Insert the calibration check rod either way the analyzer will compensate for direction Refer to Section 4 5 1 for details on performance verification with the calibration check rod QBC Hematology Control can also be tested at this time see 4 5 2 4 2 HEMATOLOGY TESTS Detailed directions for blood collection and preparation of QBC tubes for hematology tests are provided in Sections 5 and 6 and Appendix A 1 of this manual All QBC blood tubes must be inserted in the anal
18. draw 70 uL of sample when it is used for filling AccuTubes with venous blood Install the AccuTube spacer by snapping the spacer over the plunger stem of the pipetter The spacer limits the stroke of the plunger to an aspiration volume of 70 uL 6 5 6 6 ACCUTUBE QUALITY CONTROL Before testing AccuTube samples perform a daily calibration check of the QBC Autoread Plus analyzer according to the procedures in the package insert supplied with the Autoread Plus calibration check rod Cat No 424613 QBC Hematology Control Cat No 424304 is available for performance monitoring of AccuTubes These controls list assay values for AccuTubes Proficiency testing services are also available for regular performance assessment of your laboratory For addresses of testing groups contact the Technical Service Department of QBC Diagnostics Inc 1 866 265 1486 toll free 1 814 692 7661 or qbcsupport qbcdiag com 6 7 TROUBLESHOOTING TIPS FOR ACCUTUBES This section lists problems that may be encountered while preparing QBC AccuTubes or while operating the QBC Autoread Plus Problem Action Problem Action Problem Action Problem Action Problem Action AccuTube is underfilled If filling the AccuTube with a pipetter check that the spacer is placed on the pipetter correctly When filling the AccuTube by capillary action check to be sure that the blood column reaches the bottom black fill line on the
19. left side If the AccuTube is not in the Waste Tray look in the Loading Platform to see if the AccuTube is visible If one end of the tube is visible turn off the analyzer use forceps and gently lift the tube up and out of the analyzer For situations that require technical assistance call QBC Diagnostics Inc Technical Service 1 866 265 1486 toll free or 1 814 692 7661 Section 7 System Performance QBC AccuTubes 7 1 TEST RESULTS 7 1 1 Digit Decimal Format Test values generated by the Autoread Plus analyzer are displayed in the following units and decimal formats e Hematocrit 96 XX X e Hemoglobin g dL XX X e MCHC g dL XX X e Platelet Count PLT 109 L XXX e White Cell Count WBC 109 L XX X e GRANS abs 109 L XX X e GRANS rel 96 XX e YMPH MONO abs 109 L XX X e YMPH MONO rel 96 XX Mean Corpuscular Hemoglobin Concentration MCHC in grams per deciliter of red cells g dL is equal to MCHC percent 96 To convert hemoglobin to millimoles per liter multiply the value in g dL by 0 6206 to obtain hemoglobin in mmol L When testing whole blood irregularities detected in length measurement or computed values will cause the analyzer to display an error flag in certain cases the test may be aborted and no results or only partial results will be displayed 7 1 2 Operating Ranges Hematology parameters measured with AccuTubes by the QBC Autoread Plus analyzer are valid over the follow
20. the hematology parameters and acceptable ranges to be obtained with QBC Control QBC Extended Range Controls p n 424305 are also available United States users are required to run these controls every six months to meet CLIA requirements for calibration verification Extended Range Controls are available on an as needed basis The kit contains 3 levels of control material along with instructions for preparing and testing control tubes and an assay sheet showing expected values 4 8 4 5 3 QBC Proficiency Tests Proficiency testing is an external evaluation of the quality of a laboratory s performance Laboratories enrolled in a proficiency testing program will receive five unknown samples three times a year These samples are tested in the same way that patient samples are tested The results are submitted to the proficiency testing program for comparison to results obtained by other laboratories in your peer group Below is a list of proficiency testing service companies CAUTION Check the instructions accompanying the survey samples to determine which Autoread Plus analyzer mode should be used for testing them Follow the data entry instructions provided by the proficiency service Be sure to enter the correct tube type and analyzer type in the appropriate places Groups Offering QBC Hematology Proficiency Testing Services Partial Listing American Proficiency Institute API 1159 Business Park Drive Traverse Ci
21. to 32 C with AccuTube 68 F to 98 F 20 C to 37 C Non Operating 4 F to 140 F Storage Temp 20 C to 60 C Humidity 10 to 95 non condensing Weight 8 Ibs 3 6 kg Dimensions W 13 5 x D 9 5 x H 4 34 cm x 24 cm x 10 cm B 3 2 Power Pack p n 424590 Voltage 90 265 VAC Frequency 50 60 Hz Power 170 W Power Cord 8 ft 2 4 m Grounded cord and plug DC Output Cord 3 ft 0 3 m 8 wire shielded cord 9 pin male plug Weight 5 5 Ibs 2 5 kg Dimensions W 7 x D 3 75 x H 3 5 17 8 cm x 9 5 cm x 8 9 cm B 2 B 3 3 QBC Capillary Centrifuge p n 424740 Nominal Speed 12 000 rpm 80 rpm Relative Centrifugal 14 387 x g Force RCF Rotor Capacity Timer Non Operating Storage Temp Input Output at nominal speed 20 QBC blood tubes numbered tube slots Electronic 300 seconds spin 15 20 seconds deceleration 15 F to 150 F 26 C to 66 C 90 264 VAC 47 63 Hz 47 3 VDC 3 ADC Maximum steady state See QBC Capillary Centrifuge Operator s Manual for complete data Appendix C List of Parts QBC Autoread Plus System DISPOSABLE BLOOD TUBES Order No QBC AccuTubes 100 Tests 423406 QBC Venous Tubes 100 Tests 424240 1000 Tests 424237 QBC Capillary Tubes 100 Tests 424241 1000 Tests 424238 CONSUMABLES AND ACCESSORIES Hematology Controls 424304 Extended Range Controls 424305 1 8 mm Blade Lancets 420000 2 3 mm Blade Lancets 4
22. tube AccuTube is overfilled If filling the AccuTube with a pipetter check that the spacer is placed on the pipetter correctly When filling the AccuTube by capillary action check to be sure that the blood column does not go past the uppermost black fill line on the tube Blood touches stopper during fill wipe and mix steps Tip the AccuTube so that the fill end is angled down slightly With the thumb and forefinger gently pull on the stopper until the blood moves down the tube away from the stopper Seat the stopper after mixing is complete Stopper is seated after inserting float but before mixing tube Prepare another AccuTube Stopper comes out before filling Locate the end of the AccuTube farthest from the white identification line Partially insert the stopper into this end with the thumb and forefinger Proceed with filling 6 6 Problem Action Problem Action Stopper comes out after filling Locate the end of the AccuTube with the white identification line With the thumb and forefinger partially insert the stopper into the opposite end of the AccuTube Use the AccuTube illustration as a guide Continue preparing the AccuTube as described Float gets stuck after centrifugation is complete Prepare another AccuTube Problem AccuTube is dropped in analyzer Action Do not shut the door of the Autoread Plus Check to see if the AccuTube is in the Waste Tray located on the
23. 20001 REPLACEMENT PARTS Autoread Plus Analyzer w Accessories 429577 Autoread Plus Analyzer No Accessories 429576 QBC Capillary Centrifuge 425740 USB Cable 421550 Calibration Check Rod 424613 QBC Workstation 424226 QBC Pipetter 424225 Pipetter Barrel 421705 QBC AccuTube Pipetter Spacer 421706 QBC Autoread Plus Operator s Manual English 424593 QBC Autoread Plus Analyzer Software Cartridge 421923 QBC Autoread Plus Analyzer Power Pack 424590 QBC Capillary Centrifuge Power Pack 421763 QBC Line Cord USA 421634 QBC Line Cord UK 421554 QBC Line Cord Europe 421551 QBC Capillary Centrifuge Cover Assembly 421291 QBC Capillary Centrifuge Rotor Cover Access Knob 421317 Appendix D Warranty QBC Diagnostics Inc warrants the QBC Autoread Plus System to be free from defects in workmanship and materials for a period of one 1 year from the date of installation provided the System is operated in accordance with the QBC Autoread Plus System Manual During such period QBC Diagnostics Inc agrees to replace or repair any parts which in its sole judgment are found to be defective provided the System has not been subjected to misuse or abuse The warranty stated herein shall extend to the original consumer only and not to any subsequent consumer of the System QBC Diagnostics Inc shall not be liable for any incidental or consequential damages QBC Diagnostics Inc makes no other warranties expressed or implied except as stated herein
24. 424593 ii AE lt E gm o G BEEN e i Way xa up a Diagnostics Innovative Solutions for a Healthier World QBC Autoread Plus Centrifugal Hematology System Operator s Service Manual For technical assistance in the United States call 1 866 265 1486 QBC Autoread Autoread Plus and AccuTube are trademarks of QBC Diagnostics Inc 2006 QBC Diagnostics Vacutainer is a trademark of Becton Dickson Inc QBC Diagnostics Inc 4593 000 005 Rev F 168 Bradford Drive Port Matilda PA 16870 U S A 2011 04 Contents Section 1 INTRODUCTION Bol INTENDED USE Cc 1 1 SUMMARY OF TEST m 1 1 PRINCIPLES OF THE PROCEDURE u oras Qc cci det denne aie 1 2 WARNINGS AND PRECAUTIONS eege eet 1 2 Section 2 INSTALLATION PROCEDURES 2 4 M on INSTALLATION SERVICE steet Edge 2 1 AUTOREAD PLUS SYSTEM COMPONENTS a 2 1 SETUP ele 2 1 23 1 Inserting Software Cartridge 2 1 29 2 Electrical Conne etiofiSiu uuu uuu E E EE 2 2 2 3 3 QBC ee Eet 2 2 2 39 4 Power Hequlirements uuu uuu uuu inaa See Tinte dins 2 3 INITIAL ADJUSTMENTS TO ANALYZER pisei xm ean a nein 2 4 244 1 Display Contrast uuu u u eau u uu E Eu ka Vae udua pn E DRM asss 2 4 2 4 2 Selecting Display Language E 2 4 24019 Setting Calendar Olock u u pendant crisi te d taxe casa t
25. A MINOR THALASSEMIA TRAIT AND THALASSEMIA INTERMEDIA pp 884 886 ALL Ref to Wistrobe M M Clinical Hematology Ed 8 see note on HDR System Figure 4 6 Printout Test Values Plus Short HDR Report PRESS NEXT KEY AFTER TEST PRINTOUT Y Printout Options Select 4 or N For VALUES SHORT HDR press NEXT For VALUES LONG HDR press NEXT N For TEST VALUES Only press NEXT lt m Re o gt m Ro m o gt 0 m n lt m o gt 0 m n lt m Re v gt O m Ro 4 3 TEST ALERTS 4 3 1 Flashing Values and Dashes When a test value flashes on and off on the display panel an asterisk will appear on the printout after the numerical value Flashing values indicate that the result is outside the validated test range of the parameter See Table 4 1 Dashes on the panel and on the printout mean that the computed test value is outside the display range of the instrument or that a packed cell layer is too small to measure In such cases dashes and no test value and bar graph point will appear Table 4 1 shows out of range points for QBC AccuTubes With QBC AccuTubes elevated cell counts are indicated by the statement OUT OF RANGE on the printout and by the following displays High WBC Display flashes 99 9 instead of when total WBC count is over 99 9 x 109 L e High Granulocyte Count Display flashes 99 9 when Granulocyte count is over 99 9 x
26. ASURE DEVICE LOAD PLATFORM END OF TRAVEL DETECTOR Qo LOAD POSITION Q MEASURE POSITION INDEX POSITION Figure 3 10 Position Layout of Analyzer Optics POWER PACK MULTIPLE D C OUTPUT MEMBRANE CARRIAGE KEYPAD f Figure 3 11 Simplified Interconnection Diagram 3 1 7 Data Acquisition Test data is read via a 12 bit analog to digital converter A typical tube assay consists of the following a Forward and reverse transmittance and fluorescence scans of entire tube to determine tube type float length fill volume etc b One fluorescence scan of float region in forward direction with red filter in place c One fluorescence scan of float region in reverse direction with green filter in place d Tube is indexed 45 axially in carriage and fluorescence scans of b and c are repeated The above process is then repeated until eight sets of fluorescence scans are made around the circumference of the tube and float The microprocessor computes packed cell volumes and resulting test values from linear measurements of the color differentiated packed cell layers shown in Figure 3 12 QBC tube parameters are thus a function of the following lengths e Hematocrit L4 eWBC L3 and L4 GRANS L5 eL YMPH MONO L4 e Platelet Count Ls eHemoglobin Derived from L4 Lo La L4 and Ls The Lg plasma column is also measured to determine the actual fill volume which is between 65 75 uL for a QBC AccuTu
27. L 1 8 7 2 Lymphocyte Monocyte Count x 109 L 1 7 4 9 A 2 4 SPECIFIC PERFORMANCE CHARACTERISTICS A 2 4 1 Precision Data on within run reproducibility of the QBC Autoread Plus System from five blood specimens with QBC venous tubes and five blood specimens with QBC capillary tubes are shown in Table A 2 1 The means and C V s below are based on replicate tests of 10 tubes per sample e g for Sample 1 n 10 etc Table A 2 1 WITHIN RUN PRECISION QBC AUTOREAD PLUS SYSTEM QBC VENOUS BLOOD TUBES WBC 7 1 3 16 6 7 2 33 11 2 5 41 16 1 6 42 5 3 6 72 GRANS 4 6 2 71 4 9 3 07 7 9 7 3 10 6 5 86 3 6 6 2 QBC CAPILLARY BLOOD TUBES Sees HCT HB MCHC PLT per sample SAMPLE 1 MEAN 47 6 15 9 33 5 155 CV 1 87 0 74 2 17 8 91 SAMPLE 2 MEAN 23 1 7 4 31 8 288 CV 1 44 0 66 1 22 3 27 SAMPLE 3 MEAN 31 9 10 4 32 5 550 CV 1 5 1 27 1 29 3 59 SAMPLE 4 MEAN 52 3 16 3 31 1 745 CV 1 4 1 35 0 96 4 68 SAMPLE 5 MEAN 41 6 13 6 32 8 91 CV 1 73 1 45 0 8 5 34 Fe HCT HB MCHC PLT per sample SAMPLE 1 MEAN 49 1 15 3 31 2 144 CV 1 1 0 9 0 9 13 1 SAMPLE 2 MEAN 31 9 9 7 30 3 522 CV 2 0 1 1 1 7 3 7 SAMPLE 3 MEAN 54 9 16 4 29 9 582 CV 0 9 1 2 1 0 6 6 SAMPLE 4 MEAN 42 8 12 9 30 2 88 CV 0 8 0 7 0 6 9 9 SAMPLE 5 MEAN 40 8 12 5 30 7 197 CV 1 9 1 5 1 4 8 3 WBC A 2 3 8 4 6 7 11 6 4 5 15 6 2 8 5 7 5 6 5 9 7 5 GRANS 5 9 10 1 8 1 4 1
28. LARY CENTRIFUGE QBC hematology tests require the centrifugation of blood samples at the specified RCF for 5 minutes to obtain proper cell banding The QBC Capillary Centrifuge is designed to fulfill this requirement When using the QBC Capillary Centrifuge be sure to place tubes on the centrifuge rotor in a balanced array see example in Figure 4 8 Detailed operating instructions and calibration check procedures are described in the QBC Capillary Centrifuge operator s manual 4 10 MESSAGES OPTIONS MODE Select 4 v PRESS 4 KEY MESSAGES Autoread Plus Set Language PRESS 4 KEY MESSAGES Autoread Plus Set Units PRESS 4 KEY MESSAGES Autoread Plus Set Baud Rate PRESS 4 KEY MESSAGES Autoread Plus Cartridge Type PRESS 4 KEY MESSAGES Autoread Plus Set Print Format MESSAGES Autoread Plus Set Date amp Time IN APPLICABLE SOFTWARE Figure 4 8 QBC Tubes with Balance Tube in Even 4 Position For trouble shooting purposes refer to the print a diagnostic scan for technical services to interpret Table 4 3 DURING STARTUP AND SELF TEST Error Messages and Codes DURING CALIBRATION CHECK DURING HEMATOLOGY TESTS ERROR MESSAGE amp lest Failed ecksum Error 1 ecksum Error 2 alibration Error backlash ilter Whee Error 1 Position Error Remove Tube With B ing noise arriage Error no sensor D Cal Rod Error 03 n mproper QBC Tube Type an
29. OLOGY TEST PROCEDURE WITH QBC ACCUTUBE 6 1 pcm MED ede EE 6 2 6 3 2 Preparation and Handling of AccuTubes 6 2 6 4 BETWEEN SPIN TIME DELAY FOR ACCUTUBES eere 6 5 6 5 FILLING ACCUTUBES WITH VENOUS BLOOD rnnt ca dais 6 5 6 6 ACCUTUBE QUALITY CONTROL iitisaosdisxe inu eege eEeuE 6 5 6 7 TROUBLESHOOTING TIPS FOR ACGUTUBES cta Lotta iua esae iret tas vanis 6 6 Contents continued Section 7 SYSTEM PERFORMANCE 7 1 TEST RESUDTS uuu ua 7 1 TZ Digit D cimal Format uada aaa d gei uia trig ia iHd dida 7 1 7 1 2 Operating Ranges sa co rimi atento ded rbd Ue tunes dn eid asd xd dic 7 1 7 2 MELEN 7 1 7 3 EXPECTED VALUES edel 7 2 7 4 SPECIFIC PERFORMANCE CHARACTERISTICS 7 2 7 4 1 PreGISI r 7 2 7 4 2 AC CUIACY m 7 4 Section 8 Tele AE 8 1 APPENDIX A 1 TEST PROCEDURES FOR QBC VENOUS AND CAPILLARY TUBES MATERIALS PROVIDED EE A 1 1 MATERIALS REQUIRED BUT NOT PROVIDED A 1 1 A 1 2 1 QBC Tubes for Hematology Test A 1 1 el areecht Wee TEE A 1 1 A 1 3 1 Procedures with QBC Venous Tubes A 1 2 A 1 3 2 Procedures with QBC Capillary Tubes EN A 1 4 CALIBRATION IDE TASS EEN A 1 10 QUALITY EEN ELE A 1 10 A 1 5 1 QBG Ee KA A 1 10 APPENDIX A 2
30. PROCEDURE WITH QBC ACCUTUBE eBe sure QBC blood tubes have not exceeded their labeled expiration date or open vial stability Maintain laboratory temperature at 68 to 98 F 20 to 37 C eVenous blood specimen must be well mixed and at room temperature e Capillary blood collect only from free flowing finger puncture or plantar surface of heel in infants less than one year old 6 1 Section 6 Test Procedure QBC AccuTube Acridine orange reagent may be toxic do not ingest Avoid contact with skin eyes and clothing WARNING D K Blood specimens may contain the Hepatitis B Virus HBV Hepatitis C Virus HCV Human Immunodeficiency Virus HIV or other disease causing agents Handle all patient specimens as potential biohazards capable of transmitting infection Wear appropriate personal protective equipment including gloves when collecting and processing blood QBC blood tubes are made of glass Be careful when handling and preparing tubes to prevent breakage and possible injury Inspect QBC AccuTubes before use Do not use cracked or scratched tubes ACCUTUBE FLOAT LD LINE ANTICOAGULANT 70 uL NOMINAL FILL REAGENT STOPPER COATING Figure 6 1 AccuTube with Partially Seated Stopper and Separate Float 6 3 1 Description The AccuTube Figure 6 1 can be filled with either venous or capillary blood and incorporates an identification line graduated fill lines precoated reagents and a p
31. STEM COMPONENTS System Analyzer Power Pack ss ins Part No Part No Part No ritug Part No 428605 429576 424590 425740 Test accessories included with the Autoread Plus System are USB Printer U S Only e USB Printer Cable e Software Cartridge eQBC Pipetter A AccuTube Spacer e Small screwdriver for adjusting displays e Calibration check rod e Forceps for handling floats Workstation Operator s Manual this document Test disposables for QBC hematology and optional accessories are listed in Appendix C 2 3 SETUP PROCEDURES 2 3 1 Inserting Software Cartridge Note For directions on installing software cartridges with USB compatibility consult the included insert labeled IMPORTANT INFORMATION Install the software cartridge in the instrument prior to operation and while the Power switch of the unit is Off Referring to Figure 2 1 orient the cartridge so that the label faces up then insert the cartridge into the slot in the back panel Push in firmly until the cartridge finger is mated to the circuit board connector 2 1 Section 2 Installation Procedures Figure 2 1 Inserting Software Cartridge into Analyzer CAUTION Damage to electronic circuitry can occur if power is on while the cartridge is being inserted into or removed from the analyzer Always be sure the power switch is off before installing or removing the cartridge 2 3 SETUP PROCEDURES continued 2 3 2 Electrical Conne
32. The transport mechanism lead screw and guide rod are lubricated for the life of the instrument Should breakage ever occur during tube insertion or colleting a removable waste tray below the loading platform is provided to collect specimen and glass Figure 3 8 3 1 5 Optics The optics system shown schematically in Figure 3 9 consists of three basic sections Red light source for transmittance scans e Blue light source for fluorescence scans ePhotodetector with associated focusing lens and filters 3 4 SE Figure 3 8 Waste Tray Shown Partially Open WASTE BLUE LIGHT SOURCE FLUORESCENT HALOGEN LAMP INTERFERANCE FILTER E E ha as A O QBC TUBE PHOTODETECTOR CONDENSING LENS SILICON DETECTOR CONVEX FOCUSING LENS RED LIGHT SOURCE TRANSMITTANCE FILTER WHEEL Figure 3 9 Optics System Schematic 3 1 5 Optics continued The red light source is a 610 nm LED and is used primarily for scanning the red cell layers in the blood tube and for detecting tube characteristics i e closure type tube type fill volume float length etc A slit mask controls the area of illumination of the tube The blue light source is a miniature tungsten lamp for fluorescence scanning of the buffy coat An interference filter is used for blocking all light of a wavelength of 490 nm or longer An aspheric condensing lens having a focal length of 8 5
33. Tubes A 2 1 TEST RESULTS A 2 1 1 Digit Decimal Format Test values generated by the QBC Autoread Plus analyzer are displayed in the following units and decimal formats Hematocrit 96 XX X e Hemoglobin g dL XX X e MCHC g dL XX X e Platelet Count PLT 109 L XXX e White Cell Count WBC 109 L XX X GRANS abs 109 L XX X e GRANS rel 96 XX e YMPH MONO abs 109 L XX X e YMPH MONO rel 96 XX Mean Corpuscular Hemoglobin Concentration MCHC in grams per deciliter of red cells g dL is equal to MCHC percent To convert hemoglobin to millimoles per liter multiply the value in g dL by 0 6206 to obtain hemoglobin in mmol L When testing whole blood irregularities detected in length measurement or computed values will cause the analyzer to display an error flag in certain cases the test may be aborted and no results or only partial results will be displayed A 2 1 2 Operating Ranges The blood parameters measured by the QBC Autoread Plus analyzer have been validated over the following range of values for QBC standard tubes e Hematocrit 25 55 Hemoglobin 5 0 20 0 g dL e MCHC 25 0 37 3 g dL e Platelet Count 80 600 x 109 L e White Cell Count 2 0 30 0 x 109 L e Grans 1 99 0 5 29 7 x 109 L over a WBC of 2 0 30 0 x 109 L e Lymph Mono 1 99 0 5 29 7 x 109 L over a WBC of 2 0 30 0 x 109 L If the specimen yields test values outside these ranges confirmation by other meth
34. UP PROCEDURES continued 2 3 4 Power Requirements Plug the power cords of the power pack and centrifuge into the grounded electrical receptacles rated for the line voltage and frequency specified on their respective data plates For centrifuge voltage tolerances consult the operator s manual of the QBC Capillary Centrifuge supplied with the System For proper operation of the Autoread Plus analyzer the power source must deliver voltages within the limits specified below Model No Voltage Tolerance 424590 Autoread Plus 90 265 VAC Power Pack 50 60 Hz If the line voltage is known to fluctuate outside the above tolerances notify the installer a special voltage regulator may be required The analyzer is electrically energized by the rocker type POWER switch in the back of the unit see Figure 2 3 The switch is labeled with two positions 0 Off and 1 On When power is on a green LED Power indicator on the front display panel is illuminated 2 3 CAUTION Connect the power cord only to a 3 wire grounded receptacle delivering the voltage and frequency specified on the data plate of the power pack Where only a 2 wire receptacle is available have it replaced by a qualified individual and in accordance with all specified electrical codes If an extension cord is required use only a 3 wire grounded cord with the proper voltage rating 2 4 INITIAL ADJUSTMENTS TO ANALYZER 2 4 1 Display Contrast Turn power on a
35. adable 6 Patient Proficiency and Control Samples CAUSE AND ACTION Cause Improper tube inserted defective lamp or binding carriage Action Remove tube and inspect Retest or prepare and test new tube If message persists request service Cause Venous tube not filled with required amount of blood or some sample was lost during tube preparation Action Check pipetter for accuracy of fill Prepare and test new tube Cause Capillary tube not filled with required amount of blood or some sample was lost dur ing tube preparation Action Prepare and test new tube Cause AccuTube not filled with required amount of blood or some sample was lost during tube preparation Action Verify AccuTube spacer in place if using pipetter Prepare and test new tube Cause Plasma contains excess bubbles making accurate measurement of plasma column difficult Action Prepare and test new tube Cause Errors 1 and 2 Sample has blurred red cell granulocyte interface Errors 3 5 Sample has severely blurred red cell granulocyte interface Action Instrument will not report GRANS WBC or LYMPH MONOS but will report LYMPH MONO 109 L PLT HCT HB and MCHC For full test panel test fresh sample or use other test method Cause Pancytopenia resulting in extremely small hard to read cell layers Action Inspect tube for small layers if capillary sample obtain and test venous sample Cause Various leukemias result in extremely l
36. al of Medicine SC 185 58 71 Olef 1937 The Determination of Platelet Volume Journal of Laboratory and Clinical Medicine 23 166 178 Bessis M 1940 Une m thode permettant l isolement des diff rents l ments figur s du sang Sang 14 262 Davidson E 1960 The Distribution of the Cells in the Buffy Layer in Chronic Myeloid Leukemia Acta haemat 23 22 28 Zucker R M and Casse B 1966 The Separation of Normal Human Leukocytes by Density and Classification by Size Blood 34 5 591 600 Jackson J F 1961 Supravital Blood Studies Using Acridine Orange Fluorescence Blood 17 643 17 643 649 Wardlaw S C and Levine R A 1983 Quantitative Buffy Coat Analysis JAMA 5 617 620 10 11 12 18 14 Section 8 Bibliography Data on file ay QBC Diagnostics Inc Port Matilda PA 16866 Young D S Pestaner L C and Gibberman V 1975 Effects of Drugs on Clinical Laboratory Tests Clinical Chemistry 21 313D 3454D 346D 390D 391D 392D Elking M P and Kabat H 1968 Drug Induced Modifications of Laboratory Test Values American Journal of Hospital Pharmaceuticals 25 485 Williams W J Beutler E Lichtman M A Coller B S Kipps T J Ed Hematology 5th Ed New York McGraw Hill Co 1995 p 9 National Committee for Clinical Laboratory Standards Approved Standard H7 A 1985 Procedure for Determining Packed Cell Volume by the Microhemato
37. ally according to the equation MCHC HB HCT x 100 1 4 WARNINGS AND PRECAUTIONS The QBC Autoread Plus Hematology System is intended for in vitro diagnostic use Carefully observe all warnings and precautions in this manual and on labeling of QBC tubes concerning the safe handling of blood and blood derived products 1 2 PLASMA PLATELET LAYER WHITE CELLS LYMPHOCYTES amp gt FLOAT MONCYTES WHITE CELLS GRANULOCYTES RED CELLS AROUND RED CELLS FLOAT STOPPER Figure 1 3 Color Separated Layers Spun QBC Blood Tube Acridine orange reagent may be toxic do not ingest Avoid contact with skin eyes and clothing Blood specimens may contain the Hepatitis B Virus HBV Hepatitis C Virus HCV Human Immunodeficiency Virus HIV or other disease causing agents Handle all patient specimens as potential biohazards capable of transmitting infection Wear appropriate personal protective equipment including gloves when collecting and processing blood QBC blood tubes are made of glass Be careful when handling and preparing tubes to prevent breakage and possible injury Inspect QBC tubes before use Do not use cracked or scratched tubes 2 1 INSTALLATION SERVICE The Autoread Plus System will normally be installed by a QBC Diagnostics Inc representative If necessary contact your distributor or the nearest office of QBC Diagnostics Inc to arrange for installation service 2 2 AUTOREAD PLUS SY
38. arge layers of certain white cells which obscure other small cell layers e g lymphocytes Action Inspect tube for large layers if venous sample obtain and test capillary sample Cause Top of platelet layer is near or at top of float caused by extremely large layer of plate lets lymph monos or granulocytes Action Inspect tube for large layers if venous sample obtain and test capillary sample Cause Platelets clumped on top of float possibly due to poor blood collection technique or to age of blood sample Action Obtain a fresh sample and retest Cause Lymph Mono layer is extremely small or is inadequately stained Action Retest or prepare and test new tube Cause analyzer fails to find 4 out of the 8 scans of the float that yield reproducible cell counts possibly due to expired QBC tube or incorrect sample preparation Action Retest or prepare and test new tube QBC Diagnostics Systems Technical Bulletin Date Issued January 2006 Product QBC AUTOREAD Model 424576 QBC AUTOREAD PLUS Model 429576 Subject Printing Diagnostic Scans Troubleshooting Tool Only Diagnostic Scan printouts are used as a troubleshooting tool by the QBC Diagnostics Technical Services Department Blood samples from Patients QBC Controls amp Proficiency Test material can be evaluated for troubleshooting purposes only using this diagnostic procedure Diagnostic Scan information can be obtained from the QBC AUTOREAD A QBC
39. artially seated stopper It is filled with capillary blood by capillary action or with venous blood by capillary action or by means of a QBC pipetter fitted with an AccuTube spacer Nominal fill of the AccuTube is 70 uL with either blood specimen After mixing the specimen and seating the stopper the plastic float is inserted and the tube is centrifuged for 5 minutes The centrifuged tube is placed in the Autoread Plus analyzer for automatic scanning and reporting of results 6 3 2 Preparation and Handling of AccuTubes Running a Patient Sample Step 1 Fill the AccuTube Note Do not allow the blood to touch the AccuTube rubber stopper while performing this step Venous Blood Gently mix the sample at least 6 times by inversion or for 5 minutes on a mechanical mixer immediately before filling the AccuTube Tilt the blood tube as shown and place the open end of the AccuTube in contact with the blood Fill the AccuTube to between the two black fill lines Wipe the outside of the AccuTube with lint free tissue Note For instructions on use of the pipetter refer to Section 4 8 Capillary Blood Place the open end of the AccuTube in contact with the finger puncture blood Hold the AccuTube close to horizontal to avoid air bubbles Fill the AccuTube until the blood level is between the two black lines Wipe the outside of the AccuTube with lint free tissue Avoid air bubbles when filling Mix blood well with coating Step 1
40. back switching design with four individually regulated d c outputs as shown in Figure 3 13 The Power switch on the analyzer controls and cuts the 20V and 12 5V supplies the 16 5V supply being switched off electronically by cutting the 12 5V supply to the logic circuits 3 3 QBC CAPILLARY CENTRIFUGE The QBC Capillary Centrifuge Figure 3 14 is a low noise high speed instrument specifically designed to meet the cell packing requirements of the QBC test method Up to 20 blood tubes can be spun simultaneously Nominal speed is 12 000 rpm and relative centrifugal force is approximately 14 387x g Spin time is fixed at 5 minutes For a detailed description of the QBC Capillary Centrifuge including setup and operating instructions see the operator s manual shipped with the instrument Since the QBC test method depends on proper cell layering of blood the sample tubes must be protected from excessive heat in the centrifuge rotor compartment which may adversely affect cell layer formation Accordingly be sure to wait between successive spins for the correct time specified in the applicable QBC Capillary Centrifuge manual CAUTION A clinical diagnosis is a conclusion based on science and art that necessitates the full integration of the results of a detailed medical history a careful physical examination and appropriate laboratory testing together with the training experience and professional judgment of the treating
41. be Data processing incorporates various digital filter pattern recognition and data conversion algorithms The latter computations are based on the fact that each QBC tube exhibits a characteristic signature that must fall within prescribed tolerances Bandlength data from the eight pairs of scans made around the blood tube are analyzed and processed Test readings are displayed only when data analysis confirms valid bandlengths in at least four sets of scanning measurements 3 6 Ls gt L L L L FLOAT STOPPER Figure 3 12 Packed Cell Layers in QBC AccuTube 3 1 8 HDR Analysis Report The microprocessor via the cartridge memory bank contains an extensive database of medical diagnoses against which each nine parameter test result is analyzed The test printout will include a hematology diagnostic reminder or HDR report on general and specific clinical aspects relating to any abnormal values Wintrobe s Clinical Hematology 8th edition is referenced throughout the printed HDR report See the Caution note opposite on proper utilization of HDR report Abbreviated Short or detailed Long analysis reports can be obtained See Section 2 4 4 on programming HDR report printouts Not provided in all cartridges 3 2 AUTOREAD PLUS POWER PACK The power pack supplies direct current d c voltages to the Autoread Plus analyzer The power pack incorporates a conventional fly
42. centrifuge will spin for 5 minutes The lid will unlatch when the centrifuge stops Open the lid unscrew the metal cover and remove the AccuTubes Step 6 Analyze the Sample Select the CBC MODE on the QBC Autoread Plus analyzer Open the analyzer door and place the AccuTube in the analyzer with the rubber stopper to the left Close the analyzer door to start the test Step 7 Obtain Results When the test is complete the results will be displayed on the analyzer and printed Test results are cleared from the display when the analyzer door is opened Do not open the analyzer door until the results are reviewed and additional printouts are made Open the analyzer door and remove the AccuTube Discard the tube in a biohazard sharps container 6 4 Step 5 Centrifuge T pr ET M A i Step 6 Place in Analyzer Step 7 Obtain Results 6 4 BETWEEN SPIN TIME DELAY FOR ACCUTUBES Since possible exposure of blood samples to heat buildup in the centrifuge rotor compartment can adversely affect cell layering wait at least 3 minutes between successive spins if the ambient temperature is between 68 90 F 20 32 C If the ambient temperature is between 90 98 F 82 37 C a 15 minute wait period is required to allow for sufficient cooling of the rotor Between each spin be sure the rotor cover is removed and the rotor is empty 6 5 FILLING ACCUTUBES WITH VENOUS BLOOD The QBC pipetter must be modified to
43. check described in Section 4 of this manual Before running patient samples daily testing of the Autoread Plus analyzer calibration check rod is strongly recommended to verify the performance of the instrument Calibration adjustments must be made only by authorized service personnel A 1 5 QUALITY CONTROLS A 1 5 1 QBC Hematology Tests Controls and proficiency tests to monitor performance are described in 4 5 2 and 4 5 3 Reference methods for QBC hematology tests are provided below Parameter Reference Method Hematocrit Centrifugal Microhematocrit13 Hemoglobin Cyanmethemoglobin Method14 WBC ione Impedance Cell Counter GRANS nere 100 Cell Manual Differential Count LYMPH MONO 100 Cell Manual Differential Count PET aa aaa aa a gs Phase Microscopy or Impedance Cell Counter MCHTC dx Manual differential count of granulocytes should include the sum of neutrophils eosinophils and basophils for comparison with the GRANS count of Autoread Plus analyzer Manual differential count should include the sum of lymphocytes and monocytes for comparison with the LYMPH MONO count of Autoread Plus analyzer MCHC of the Autoread Plus analyzer is a calculated value derived from the hematocrit and hemoglobin Comparison of these latter parameters with the recommended reference methods will ensure accuracy of MCHC A 1 7 System Performance with Appendix A 2 QBC Standard
44. crit Method National Committee for Clinical Laboratory Standards NCCLS Approved Standard H15 A 1985 Reference Procedure for Quantitative Determination of Hemoglobin in Blood Test Procedures for QBC Venous and Capillary Tubes A 1 1 MATERIALS PROVIDED The QBC Autoread Plus Hematology System consists of the following instruments and accessories with which to perform hematology tests eQBC Autoread Plus Analyzer with software cartridge QBC Power Pack e QBC Capillary Centrifuge e Printer Calibration Check Rod Workstation e Forceps e QBC Pipetter A 1 2 MATERIALS REQUIRED BUT NOT PROVIDED A 1 2 1 QBC Tubes for Hematology Tests The following disposables are available for QBC Hematology tests e QBC Venous Tubes 100 Tests 424240 1000 Tests 424237 QBC Capillary Tubes 100 Tests 424241 1000 Tests 424238 A 1 3 HEMATOLOGY TEST PROCEDURES eBe sure QBC blood tubes have not exceeded their labeled expiration date or open vial stability Maintain laboratory temperature at 68 to 90 F 20 to 32 C eVenous blood specimen must be well mixed and at room temperature For a valid platelet count blood must be less than 90 minutes old e Capillary blood collect only from free flowing finger puncture or plantar surface of heel in infants less than one year old Interfering Substances eHemolysis Do not perform tests on visibly hemolyzed blood specimens e Bilirubin No effects on test result
45. ctions e Analyzer to Power Pack Referring to Figure 2 2 insert the 8 pin plug of the power pack into the POWER PACK CONNECTOR in the back of the Autoread Plus analyzer Before plugging the line cord of the power pack into an electrical receptacle see the electrical requirements specified on the data plate and in Section 2 3 4 e Analyzer to Printer Note For analyzers with USB printers consult the included insert labeled IMPORTANT INFORMATION In order to connect the printer the cable assembly supplied with the System must be installed between the Autoread Plus analyzer output port and the printer Referring to Figure 2 3 attach the cable as follows a Insert the 25 pin plug of the cable assembly into the PRINTER connector in the back panel of the analyzer b Secure the plug to the connector by manually tightening the knurled captive screws into the sockets of the connector Note the captive screws are slotted and can be tightened with a screwdriver c Plug the unattached connector of the cable into the jack on the printer See the manufacturer s manual furnished with the printer for instructions on attaching accessories 2 3 3 QBC Capillary Centrifuge Consult the separate manual supplied with the QBC Capillary Centrifuge for detailed setup instructions power requirements and operating directions Figure 2 2 Power Connection Diagram 2 2 Figure 2 3 Printer Cable Connection 2 3 SET
46. ditionally please include the sample type being tested e QBC Control or other vendor s control Proficiency Test or patient blood sample Please use a coversheet that includes your name office name and a return phone number 4 13 4 9 QBC PIPETTER The QBC pipetter Figure 4 9 is a fixed volume device designed to aspirate 111 1 uL of blood to fill standard QBC venous tubes An AccuTube spacer is used to adjust the fill volume to 70 uL when using QBC AccuTubes The QBC pipetter incorporates a movable barrel as shown in Figure 4 10 The barrel is opened by twisting it forward When opened the pipetter accepts the stoppered end of an AccuTube or the open end of a standard QBC venous tube When closed the pipetter holds the tube in place and seals it around its outside permitting a vacuum to be drawn Insert tubes gently into the open barrel Pushing forcefully will prematurely seat the stopper of an AccuTube Once inserted close the barrel by twisting it backward Depress plunger Insert QBC Tube into well mixed blood Release to fill Tilt pipetter upward Twist barrel forward to OPEN remove QBC Tube Note To prevent damage to laboratory gloves hold the barrel at the ribbed area when turning see Figure 4 11 IMPORTANT Always leave the barrel open when the pipetter is not in use SPACER Figure 4 9 QBC Pipetter YN OPEN QUI AIP STOPPER END Figure 4 10 Barrel of QBC Pipetter F
47. e Incorrect or damaged calibration check rod Damaged collet Optics require service Action Verify use of correct Call Check Rod Wipe clean and retest If message persists request service Cause Mode on instrument incorrect for sample being tested i e calibration check rod tested in CBC or Insert QBC Tube mode Action Remove tube and insert correct type or access correct test mode Cause Severely hemolyzed specimen severe platelet clumping on top of float improperly prepared tube missing float tube filled backwards smudged tube missing fill lines or wrong tube type Action Remove tube and inspect Retest or prepare and test new tube Cause Closure or stopper in QBC tube is incorrectly sealed or LED is defective Action Prepare and test new tube If message persists request service Cause Severely hemolyzed specimen defective float float lodged in wrong part of tube improperly prepared tube defective lamp or defective LED Action Remove tube and inspect Retest or prepare and test new tube If message persists request service 4 11 able 4 3 continued DURING STARTUP AND SELF TEST Error Messages and Codes DURING CALIBRATION CHECK DURING HEMATOLOGY TESTS ERROR MESSAGE rror Locating Meniscus mproper Fi Venous Sample mproper Fi Capillary Sample mproper Fill AccuTube Sample oo Many Bubbles Found in Tube ranulocytes Unreadable 1 Buffy Coat Unreadable Q 3 4 5 Buffy Coat Unre
48. e is completely seated and properly aligned Failure to align and seat closure properly may result in blurred interfaces A 1 2 B1 With 424240 Tray CAUTION Do not force closure onto tube Tube is made of glass and may break Step 2 Roll Tube Between Fingers to Mix Gently roll tube between fingers at least 10 times or for at least 5 seconds keeping unsealed end slightly above horizontal D Proceed promptly to Step 3 Step 3 Insert Float With 424240 Tray Slide unsealed end of tube over tip of pre positioned float E1 and push until float is inside tube as far as possible Gently lift closure end of tube until float releases from its tray slot Raise unsealed end of tube slightly above horizontal to prevent float from falling out If necessary press end of float against clean surface until float is inside tube NOTE Never touch floats with fingers or gloves Use forceps to handle loose or dropped floats With 424237 Box Using forceps supplied with analyzer pick up float from well Insert forceps held float into unsealed end of tube E2 With forceps tap float into tube Never touch float with fingers or gloves Note After inserting float tubes can be held for centrifuging provided they are stored vertically closure down in workstation A maximum of 15 minutes is allowable between insertion of float and centrifugation Step 4 Centrifuge for 5 Minutes Place blood tubes in centrifuge Spin dow
49. e Hematology Diagnostic Reminder or HDR program the test printout format can be pre selected from a menu of print options Using the MODE key advance the display to the OPTIONS MODE see opposite access the SET PRINT FORMAT display by means of the 4 or v key followed by the PRINTOUT OPTIONS display using the NEXT key Use the 4 or key to preview the print options Pre program the analyzer to print out test results in one of three formats or opt for no printout at all Short vs Long HDR s differ in diagnostic detail the Short form providing a summary or abbreviated report of the test result analyses Press the NEXT key to enter the desired selection Upon pressing NEXT to set the format the operator will be given the choice of obtaining results on a printed page or label After the page or label selection the display will return automatically to the SET PRINT FORMAT Exit by means of the MODE key The print format set here will be the format used to print out test results automatically after an assay is completed Note The printout format can be temporarily changed after the completion of a test See procedures in Section 4 2 3 2 6 CAUTION Be sure printer is approved for use and compatible with analyzer before connection to instrument MESSAGES OPTIONS MODE Select 4 RESS 4 TWICE MESSAGES Autoread Plus Set Print Format d PRESS NEXT MESSAGES Printout Options Select
50. e Reading Centrifuged QBC tubes are stable for up to 4 hours prior to reading if stored vertically closure down in workstation away from heat and intense light IMPORTANT Excessive heat may disturb cell interfaces in centrifuged blood tube Avoid picking up or handling spun tube below plasma column Do not place centrifuged tubes on warm surfaces or under intense light eDo not leave blood tubes on rotor after centrifugation Remove and read immediately or temporarily store in vertical closure down position eDo not twist or move tube closures after centrifugation Step 4 Place Tube in Analyzer Place centrifuged capillary tube onto loading platform of Autoread Plus analyzer select normal range of patient if desired close platform door ASSAY IN PROGRESS will appear on message display followed by test sequence described in Section 4 2 2 Leave door closed until assay is completed and test results are displayed and printed See Section 4 2 3 Remove tube and insert next centrifuged QBC venous or capillary blood tube A 1 6 Blood specimens may contain the Hepatitis B Virus HBV Hepatitis C Virus HCV Human Immunodeficiency Virus HIV or other disease causing agents Handle all patient specimens as potential biohazards capable of transmitting infection Wear appropriate personal protective equipment including gloves when collecting and processing blood A 1 4 CALIBRATION DETAILS Perform the calibration
51. e pediatric test shown because of a high or low absolute count of one or both of the WBC differentials the printout will include the caution statement at the bottom of Figure 4 5 The printout in Figure 4 6 shows test values accompanied by a short or abbreviated HDR report If the printer is not On Line when test results are displayed the automatic printing function is disabled In order to obtain a printout perform the following e Activate the On Line switch on the printer then e Press the NEXT key on the analyzer A second copy of any printout can be obtained by pressing the NEXT key while the test results are still on display Pressing NEXT also allows the operator to temporarily select a new printout format for example to change from Short to Long HDR Printouts for succeeding tests will return to the printing format originally programmed in Section 2 4 4 4 2 4 Assaying Additional Tubes Results from a completed test will remain on display until the QBC tube is removed from the carriage Upon removal of the tube the instrument will return to the start of the operational loop of the test mode i e CBC MODE Test results should therefore be recorded manually or printed before removing the tested QBC tube from the instrument Before a repeated or new test always enter the patient s normal range 4 5 QBC AUTOREAD Plus HEMATOLOGY ANALYZER Date OCT 14 1996 Time 02 00 PM 4 Pediatric Ran
52. ead Plus Hematology System PLATELETS LYMPHOCYTES amp MONOCYTES GRANULOCYTES Plasma Sp Gr 1 027 Buffy Coat Platelets amp White Cells Sp Gr 1 050 1 080 Red Cells Sp Gr 1 080 1 110 Figure 1 2 Cell Layering in Spun Microhematocrit Tube 1 1 1 3 PRINCIPLES OF THE PROCEDURE QBC hematology tests utilize precision bore glass tubes pre coated with potassium oxalate acridine orange fluorochrome stain and an agglutinating agent QBC tubes made specifically for capillary blood finger stick samples additionally contain a coating of anti coagulants During high speed centrifugation of the blood filled tube the cells form in packed layers around the float which has descended into the buffy coat Figure 1 3 8 The Autoread Plus analyzer accommodates all QBC tube types The spun tube is inserted in the analyzer where it is automatically scanned and fluorescence and absorbance readings are made to identify the expanded layers of differentiated cells Volumes of these packed cell layers are then computed to obtain quantitative values of the following e Hematocrit e Hemoglobin e Mean Corpuscular Hemoglobin Concentration e Platelet Count eWhite Blood Cell Count e Granulocyte Count and number eLymphocyte Monocyte Count 96 and number Hemoglobin is computed from density factors that determine its cellular concentration Mean corpuscular hemoglobin concentration is calculated electronic
53. ect setting then press NEXT to advance to the next step To exit the clock setting option ePress 4 or to select and set the test printout format see 2 4 4 or e Press MODE to advance to the CBC MODE After initial re setting of the clock periodically check the date and time If the date slips by one day the clock battery is probably running low Note estimated minimum service life of the battery is 10 years battery replacement however must be performed by an authorized service representative 2 5 MESSAGES 9 August 1996 10 51 d MESSAGES August 9 1996 10 51 am MESSAGES OPTIONS MODE Select a v PRESS 4 KEY MESSAGES Autoread Plus Set Date amp Time PRESS NEXT MESSAGES Time Format 12 4 24 4 12 HRS v 24 HRS MESSAGES PRESS NEXT Set Year Year 96 USE 4 OR MESSAGES PRESS NEXT Set Month Month 8 USE 4 OR MESSAGES PRESS NEXT Set Day Day 9 USE OR MESSAGES PRESS NEXT Set Hour Hour 10 USE 4 OR MESSAGES PRESS NEXT Is it AM or PM AM PM USE 4 OR MESSAGES PRESS NEXT Set Minute Minute 51 USE 4 OR MESSAGES PRESS NEXT AUGUST 9 1996 10 51 AM i PRESS NEXT MESSAGES Autoread Plus Set Date amp Time PRESS MODE TO EXIT 2 4 INITIAL ADJUSTMENTS TO ANALYZER continued 2 4 4 Setting Printout Format When the QBC Autoread Plus analyzer is equipped with software that incorporates th
54. fy satisfactory performance of the analyzer before testing patient samples The calibration check rod should be tested daily following the startup self check procedures The calibration check rod however can be tested any time As indicated in the message routine opposite once the CAL CHECK MODE is accessed and the calibration check rod inserted the assay proceeds in the same manner as a QBC blood test see 4 2 2 Upon completion results are displayed and automatically printed out The calibration check printout see opposite indicates whether the check results are acceptable i e whether they fall within the factory calibration ranges printed on the insert supplied with the calibration check rod If results are high or low the calibration check rod should be inspected for cleanliness and if necessary wiped with alcohol dried and re tested Failure to obtain results within the factory calibration range after cleaning indicates a possible malfunction of the analyzer In such cases request service 4 7 Improper QBC Tube Type lt m o gt m n MESSAGES CAL CHECK MODE Insert Cal Rod MESSAGES i CAL CHECK MODE Close Door MESSAGES i Cal Check Rod Test Scan and Analysis of Cal Check Rod _ ll QBC AUTOREAD Plus HEMATOLOGY ANALYZER Date JUNE 11 1996 Calibration Check Rod Time 11 51 Factory Calibration Ranges Low 35 13 33 1 35 7 Acceptable High L N I
55. ges iVLi Low Normal Hight vas Patient 6 Years AccuTube Sample Hematocrit 30 8 Hemoglobin 10 1 g dl MCHC 32 8 g dL Total W8C s 12 1 x10 L Granulocytes 6 6 x10 L XGranulocytes 5 x Lymphs Monos 5 5 x10 L 0 0 XLymphs Monos 4 x Platelets 402 x10 L 150 Age Group 2 9 0 C L I I1 1 3 4s0 CL I I 28 1 1 3J3 Although the total WBC is witnin the expected limits greater attention should be given to the absolute count of the GCranulocytes and or the Lymphs Monos which in thie case may be increased or decreased Figure 4 5 Printout Test Values Only Q8C AUTOREAD Plus HEMATOLOGY ANALYZER Date OCT 14 1996 Time 01 57 PM L au L ivLiLow M 40 54 LX I on ee Sa F 27 47 PEPUT I 1 3 M 14 18 F 12 16 C ICT 1 173260 4 3 10 0 CT L NT J 1 8 7 2 CTT een pl 0 7 4 9 El 140 400 Ell Patient AccuTube Sample Normal iWighivti Hematocrit 20 7 Hemoglobin z 10 8 g dL MCHC Total WBC Granulocytes 6 6 x10 L XGranulocytes 57 X Lymphs mMonos 4 9 x10 L XLymphs Monos 42 X Platelets 403 x10 L 2 9 g dL 11 5 x10 U GENERAL HEMATOLOGIC CLINJCAL REMINDERS ANEMIA pp 529 558 and Table 20 1 p 541 IRON DEFICIENCY ANEMIA pp 617 645 HEMOLYTIC ANEMIA RED CELL ayaa pp 958 971 ANEMIA OF CHRONIC DISEASE pp 646 65 THALASSEMI
56. he input output connectors and controls located on the back of the instrument The analyzer has no voltage or frequency dependent circuitry and operates on direct current voltages supplied from a separate power pack The hinged display of the unit Figure 3 3 permits viewing of results as well as access to the function keys and tube loading platform A QBC tube is inserted by opening the hinged platform door and placing the tube into the slotted platform open end facing right toward the optics chamber The door is then closed to initiate the test measurement The ensuing procedure is automatic requiring no operator involvement 3 1 Section 3 Principles of Operation no j Figure 3 1 Autoread Plus Analyzer Storage Condition POWER SWITCH POWER CORD CONNECTOR RS 232 COMPUTER PORT CARTRIDGE SLOT PRINTER CONNECTOR Figure 3 2 Rear Panel Connector and Controls Figure 3 3 Display Panel Loading Platform and Keys 3 1 2 Display Panel Readouts and controls on the display panel Figure 3 4 are as follows ePOWER light Green LED illuminated when rear POWER switch is On e Eight 3 digit windows with reflective type LCDs and fixed decimals e Upper CONTRAST adjustment for test readouts MESSAGES display two 16 character lines for alphanumeric messages eLower CONTRAST adjustment for the readout When a test is completed the results are displayed in the eight labeled windo
57. ic reminders in software cartridges programmed for HDR Note The QBC tube can be inserted into the loading platform before or immediately after selecting the normal range 4 2 2 Starting An Assay An assay is started as soon as the loading platform door is closed Upon closing the door the display will promptly advance to ASSAY IN PROGRESS 4 3 MESSAGES CBC MODE Insert QBC Tube 4 2 2 Starting An Assay continued As shown in the message sequence opposite current status of the assay is maintained on the display until test values appear IMPORTANT Once a test is started do not open the loading platform door until the test is completed and results are displayed Opening the door while an assay is in progress will cause the test to abort To repeat an aborted assay close the door wait for the tube to return to the loading platform and remove the tube Reinsert the tube program the normal range and close the door again to repeat the assay Figure 4 4 shows a typical display of test results for the nine analyzer parameters Identification of the QBC tube type AccuTube venous or capillary appears on the bottom line of the message display For a description of test printouts see 4 2 3 4 2 3 Hematology Printouts Note Some aspects of the following section may not specifically pertain to Autoread Plus systems with USB printers Consult the included insert labeled IMPORTANT INFORMATION and your printer man
58. igure 4 11 Correct Barrel Adjustment Location 4 10 PRECAUTIONS AND HAZARDS ELECTRICAL SAFETY ePower Connections Plug the cordsets of the power pack centrifuge and printer only into AC receptacles rated at the voltage and frequency specified on the data plates e Grounding Never remove the grounding prong from the cordset plugs of the power pack centrifuge and printer e Repairs Always unplug the power cord before attempting any repairs or service eDefective Cords If a power cord or plug is damaged promptly request replacement service HANDLING PRECAUTIONS e Biohazards Blood specimens may contain the Hepatitis B Virus HBV Hepatitis C Virus HCV Human Immunodeficiency Virus HIV or other disease causing agents Handle all patient specimens as potential biohazards capable of transmitting infection Wear appropriate personal protective equipment including gloves when collecting and processing blood QBC Tube Centrifugation QBC Blood Tubes are made of glass Be careful when handling and preparing tubes to prevent breakage and possible injury Inspect QBC Tubes before use DO NOT use cracked or scratched tubes Always install the rotor cover tightly before centrifuging blood tubes to prevent breakage Position Error Message Always use forceps to remove tube from instrument Carefully follow instructions or message display to prevent breakage of tube inside instrument e Tube Breakage If a QBC t
59. ing range of values 15 6596 5 0 20 0 g dL 20 999 x 109 L e Hematocrit e Hemoglobin e Platelet Count e WBC Count 1 6 99 9 x 109 L e Granulocyte Count 0 8 70 0 x 109 L e Lymph MonoCount 0 8 99 9 x 109 L Results that fall outside these ranges may be confirmed by alternate methods Results that fall outside these ranges will flash on the QBC Autoread Plus display and will be preceded by an on the printout 7 1 7 2 TEST LIMITATIONS Quality medical care requires that laboratory values be correlated with each patient s symptoms and signs by a trained practitioner Section 7 1 2 lists the validated upper and lower limits of the operating range Values above and below these validated ranges should be confirmed by an alternate method The AccuTube has been formulated to provide optimum packing and layering of normal cells In a small number of patients however the system cannot read certain parameters and will not report a value User errors in processing or use of outdated or inappropriately stored tubes can also result in non reported results Practitioners must not assume that unreported values are normal further testing with an alternative method is essential 7 2 TEST LIMITATIONS continued Automated granulocyte and lymphocyte monocyte differential counts cannot replace the conventional manual differential Due to the grouping by density of the cell populations by the QBC test method the system can
60. ion tests on AccuTubes tested in the QBC Autoread Plus analyzer are shown in Tables 7 1a and 7 1b The precision data represents the analysis of ten whole blood specimens each assayed in replicates of 10 Table 7 1a Precision Parameter Mean Value C V HCT 96 40 4 0 6 96 HB g dl 13 3 0 6 96 PLT x 109 dl 287 4 4 96 WBC x 109 dl 8 1 6 3 96 Table 7 1b Precision Parameter Range S D GRAN 96 40 80 3 3 LYMPH MONO 96 20 55 3 3 7 4 1 Precision continued In a separate precision study intra and inter run multiple days at three sites using QBC AccuTubes precision were assessed using a dual level QBC and the QBC Autoread Plus System The results of Control 424304 The controls were assayed on this study are presented in Table 7 2 Table 7 2 AccuTube Precision Using QBC Control Normal Level Abnormal Level Intra run Inter run Intra run Inter run Parameter Site Mean Value CV df CV df Mean Value CV df CV df 1 33 67 1 28 28 0 14 28 47 0 94 26 0 66 14 HCT 2 33 87 0 92 22 0 11 28 49 1 10 22 0 11 3 34 75 0 51 24 0 12 29 34 0 82 24 0 12 1 11 85 0 47 28 0 32 14 10 09 0 68 28 0 14 HGB g dL 2 11 96 0 56 22 0 11 10 24 0 43 22 0 21 11 3 12 15 0 58 24 0 12 10 35 0 61 24 0 12 1 386 89 5 15 28 5 09 14 141 05 6 03 28 4 14 14 PLT x 109 L 2 387 91 6 69 22 8 88 11 128 50 5 38 22 2 96 11 3 330 37 4 50 24 1 09 12 129 38 4 74 24 2 70 12 1 9 55 9 07 28 6 70 14 19 06 9 05 28 0 14 WB x
61. mm concentrates the light energy onto the tube In order to maintain a constant relative position with respect to the photodetector the blue light source is mechanically attached to the analyzer frame The tube which moves along its longitudinal axis remains vertically perpendicular to the light source during the scanning process The light source is movable for adjustment purposes only A position layout of the optics chamber is shown in Figure 3 10 3 1 6 Electronics The electronics of the analyzer Figure 3 11 consists of a single chip microcomputer allocated by function to the following four circuit boards eMain PC board mounted in base of lower housing eMemory PC board located in removable cartridge with up to 512K bytes of UV erasable program EPROM e Display PC board eOptics PC board photodetector pre amplifier and circuitry within shielded enclosure behind filter wheel housing The main PC board provides all of the instrument control functions including the filter wheel and transport motor controls illumination control printer outputs timekeeping data storage signal conditioning and digitizing 3 5 SILICON DETECTOR LENS 490 CUTOFF FILTER FLUORO SOURCE LAMP BLUE ie FILTER WHEEL TUBE SUPPORT OPTICAL SLIT INDEXING PINS tens eg COLET AGAMN rN yr h1 m1 TUBE SENSOR Kee SLIT RED L E D TRANSMITTANCE SOURCE ME
62. n according to instructions in centrifuge manual When centrifugation is complete promptly remove tubes With 424237 Tray Time Delay Between Completion of Centrifugation and Tube Reading Centrifuged QBC tubes are stable for up to 4 hours prior to reading if stored vertically closure down in workstation away from heat and intense light IMPORTANT e Excessive heat may disturb cell interfaces in centrifuged blood tube Avoid picking up or handling spun tube below plasma column Do not place centrifuged tubes on warm surfaces or under intense light eDo not leave blood tubes on rotor after centrifugation Remove and read immediately or temporarily store in vertical closure down position eDo not twist or move tube closures after centrifugation AAS Step 5 Place Tube in Analyzer Place centrifuged venous tube onto loading platform of Autoread Plus analyzer select normal range of patient if desired then close platform door ASSAY IN PROGRESS will appear on message display followed by test sequence described in Section 4 2 2 Leave door closed until assay is completed and test results are displayed and printed See Section 4 2 3 Remove tube and insert next centrifuged QBC venous or capillary blood tube A 1 3 2 Procedures with Standard QBC Capillary Tubes Note Handling differences illustrated in the procedures that follow are due to differences between the 100 Test p n 424241 and 1000 Test p n 424238
63. nd number eLymphocyte Monocyte Count 96 and number The Autoread Plus System consists of the Autoread Plus analyzer with replaceable software cartridge and interconnecting power pack a printer the QBC Capillary Centrifuge and various test accessories Depending on the software version of the software cartridge an analysis of test results is performed by a computerized reference program the resulting printout provides a hematology diagnostic reminder HDR report on abnormal conditions for clinical follow up by the physician 1 2 SUMMARY OF TEST The methodology ofthe QBC testis based on electro optical linear measurements of the discrete layers of packed blood cells in a microhematocrit type tube Figure 1 2 The cell layering results from density gradients formed during high speed centrifugation of the blood 1 6 Nine primary hematology values including the platelet count are derived A diagnostic report on abnormal parameters is provided based on computer stored hematologic data against which the test values are analyzed Tests are entirely automatic requiring only that the operator prepare the sample tube and insert it into the instrument Results including the HDR report take approximately 1 minutes to obtain depending on the software version Hematology diagnostic reminder HDR program not contained in all software versions Section 1 Introduction PRINTER AUTOREAD PLUS ANALYZER Figure 1 1 QBC Autor
64. nd test the calibration check rod see Section 2 6 Check for readability of the displays while room light is at its normal working level If necessary turn the upper CONTRAST adjustment Figure 2 5 with the accessory screwdriver clockwise darker counterclockwise lighter Use the lower CONTRAST control to adjust the MESSAGES display 2 4 2 Selecting Display Language The procedures below describe how to select the desired display language with software cartridges that permit multilanguage displays Upon powering up for the first time e with a new cartridge the display language will be English To program a different display language with cartridges that contain multilanguage software proceed as follows a Firstallow the analyzer to complete a Self Check Sequence see Section 4 1 1 b Then press the MODE key until the OPTIONS MODE SELECT is obtained c Use the 4 or keys to scroll through the following option functions Set Language Set Units Set Baud Rate Cartridge Type Set Print Format Set Date amp Time LIE TJEYETE TE d Press NEXT when the SET LANGUAGE option is displayed e Follow the SET LANGUAGE display and reet routine shown opposite to set he dente NEXT language 2 4 CONTRAST ADJUSTMENT FOR TEST DISPLAYS CONTRAST ADJUSTMENT FOR MESSAGE DISPLAY Figure 2 5 Display Contrast Adjustments MESSAGES AUTOREAD PLUS Set Language d PRESS NEXT MESSAGES
65. not ID QBC Tube Type rror Locating Bottom of RBC s rror Locating Float Patient Proficiency and Control Samples CAUSE AND ACTION Cause Display message will flash if software determines the Lamp is either open or shorted Action Request service Cause Defective cartridge Action Turn Power switch off remove cartridge and re install turn Power on and try again If error persists order a replacement cartridge Cause Defective cartridge Action Turn Power switch off remove cartridge and re install turn Power on and try again If error persists order a replacement cartridge Cause Loose motor coupling or carriage not moving freely Action Request service Cause Defective filter wheel defective LED carriage not moving or defective circuit board Action Request service If message occurs on powering up error is a holdover from the last procedure Cause During carriage return tube ejected improperly by collet Action Open door carefully remove tube with forceps Follow display messages by pressing NEXT key then simultaneously pressing 4 and keys Cause Transport mechanism is not moving due to a 1 defective power pack 2 jammed carriage or 3 defective circuit board Action Request service Cause Incorrect or damaged calibration check rod Damaged collet Optics require service Action Verify use of correct Call Check Rod Wipe clean and retest If message persists request service Caus
66. not discriminate between normal and abnormal cell types in disease states characterized by the presence of abnormal white cell types or nucleated red blood cells If abnormal cell populations are suspected verification of QBC test results or testing and diagnosis by alternative methods is essential The combined lymphocyte monocyte count should not be used to test for lymphocytopenia in evaluating patients with known or possible immunodeficiencies Further evaluation of lymphocyte monocyte counts in relevant situations must include a manual differential and lymphocyte subset analysis The presence of abnormally sized platelets may lead to discrepancies between the QBC test method platelet count which is based on platelet mass and results obtained with an impedance counter which are based on measurement of particle number 7 3 EXPECTED VALUES The following table provides normal ranges reported in the literature 1 12 Offices or laboratories may choose to develop normal hematology ranges based on the characteristics of their patient population Parameter Range Hematocrit Males 96 42 50 Hematocrit Females 96 36 45 Hemoglobin Males g dL 14 18 Hemoglobin Females g dL 12 16 MCHC g dL 31 7 36 0 Platelet Count x 109 L 140 440 WBC x 109 L 4 3 10 0 Granulocyte Count x 109 L 1 8 7 2 Lymphocyte Monocyte Count x 109 L 1 7 4 9 7 4 SPECIFIC PERFORMANCE CHARACTERISTICS 7 4 1 Precision Data on typical within run precis
67. nous blood with disodium or tri potassium EDTA The use of other anticoagulants is not recommended 5 1 3 Interfering Substances QBC AccuTubes eHemolysis Do not perform tests on visibly hemolyzed blood specimens e Bilirubin No effects on test results have been observed at biliruben concentrations up to 20 mg dL 9 e Triglycerides No effects on test results have been observed at triglycerides concentrations up to 1 800 mg dL 9 eCoumadin Anticoagulant therapy has been shown to have no clinically significant effect on performance 9 e Doxorubicin Treatment with the anthracyclic drug Doxorubicin does not appear to interfere with the QBC test method 9 eOther drugs The effects of other potentially interfering drugs and their metabolites on QBC tests have not been established 10 11 Interfering substances information for all other QBC tube types can be found in Appendix A 1 5 1 Blood specimens may contain the Hepatitis B Virus HBV Hepatitis C Virus HCV Human Immunodeficiency Virus HIV or other disease causing agents Handle all patient specimens as potential biohazards capable of transmitting infection Wear appropriate personal protective equipment including gloves when collecting and processing blood Product of BD Vacutainer Systems 5 1 4 Specimen Storage and Stability QBC AccuTubes Venous blood samples may be stored at room tem perature 68 to 77 F 20 to 25 C for up to 8 hours prior to
68. ods is recommended On the display of the analyzer test results falling outside the above ranges will flash off and on A 2 1 A 2 2 TEST LIMITATIONS Quality medical care requires that laboratory values be correlated with each patient s symptoms and signs by a trained practitioner Section A 2 1 2 lists the validated upper and lower limits of the operating range Values above and below these validated ranges should be confirmed by an alternate method Test values cannot be derived by the Autoread Plus analyzer unless distinct cell layers with well defined interfaces form in the blood tube Non separation or cell streaming can occur under certain hematologic or pathologic conditions e g when an orange yellow layer of granulocytes fails to form in the QBC tube or when the lower boundary of granulocytes is so poorly defined that the instrument cannot detect a clear interface The condition is generally the result of a shift in red cell specific gravity toward that of the granulocytic leukocytes causing the red cells and granulocytes to intermingle Studies indicate that the frequency of unreadable QBC tubes among ambulatory office patients of the general practitioner should average less than 1 Among clinical out patients and hospital patients the frequency of unreadable tubes may range from 1 5 to 10 depending on the pathologies of the patient group 9 User errors in processing or use of outdated or inappropriatel
69. physician The statements derived by the HDR program are suggestions based upon a limited examination of only a part of a patient s hematologic status HDR reminders have value only to a clinician who is able to use them as part of the complete diagnostic process DC OUTPUT Figure 3 13 Power Pack Outputs Figure 3 14 QBC Capillary Centrifuge p n 425740 3 4 PRINTER For U S customers a printer is supplied with the Autoread Plus System For international customers a printer with the correct voltage rating must be procured locally Note For additional information on working with USB printers consult the included insert labeled IMPORTANT INFORMATION Detailed directions on unpacking set up and operation of the printer are provided in the manufacturer s manual supplied with the unit 3 5 WORKSTATION ACCESSORY The QBC workstation Figure 3 16 p n 424226 is a convenient accessory to facilitate the preparation and storage of blood collection and centrifuged QBC tubes The workstation incorporates a receptacle for the QBC venous blood pipetter differently sized tube wells and a notched and numbered front rack for centrifuged QBC tubes 3 6 VENOUS BLOOD PIPETTER The semi automatic QBC pipetter shown in Figure 3 16 is a dedicated device for filling QBC tubes from a Vacutainer brand or similar blood collection tube Fill volume is fixed at 111 1 uL for filling standard or venous blood tubes with specimen
70. preparation of AccuTubes Samples that cannot be tested immediately must be refrigerated if the room temperature is above 77 F 25 C Refrigerated samples stored at 36 to 46 F 2 to 8 C are stable for up to 8 hours Bring samples back to room temperature before you prepare an AccuTube The AccuTube should be centrifuged within 15 min utes after the plastic float is inserted Once tubes are centrifuged the AccuTube is stable for 4 hours before testing providing the AccuTube is stored vertically with stopper end down and away from heat and intense light Specimen storage and stability information for all other QBC tube types can be found in Appendix A 1 5 2 CAPILLARY BLOOD FOR HEMATOLOGY Fill QBC AccuTubes or other QBC capillary blood tubes directly from a finger puncture or in infants a heel puncture see below AccuTubes and capillary blood tubes contain dry anticoagulant coatings which must be mixed after filling as described in the test procedures in Section 6 and Appendix A 1 5 2 1 Collection Procedures e For finger puncture blood the finger must not be cyanotic or edematous If cyanotic or cold immerse hand in warm water 30 C to 40 C for 3 to 5 minutes before puncture or use a moist compress or warm pack e The lateral or medial plantar surface of the heel is an acceptable capillary blood collection site for infants less than one year old eClean finger or heel area with antiseptic agent and wipe dry
71. r Calibration adjustments failure of internal lamps or mechanical electrical problems must be referred to a qualified QBC Diagnostics Inc service technician B 2 2 Power Pack There are no customer serviceable parts on the power pack The unit however is protected by internal overload and thermal fuses If the power pack fails to supply d c outputs to the analyzer check the electrical line to the receptacle that supplies current to the power pack before requesting service B 2 3 QBC Capillary Centrifuge The operators manual supplied with the QBC Capillary Centrifuge contains detailed instructions and procedures for performing operator authorized service and repairs B 2 4 QBC Pipetter Blood leakage or failure of the QBC pipetter to aspirate blood to the correct level may indicate that the pipetter barrel mechanism is worn and should be replaced Replacement barrels Part No 421705 can be ordered through your distributor B 1 For technical assistance in the United States call QBC Diagnostics Inc Technical Service 1 866 265 1486 toll free Outside the United States call 1 814 692 7661 or contact your distributor or nearest QBC Diagnostics Inc office B 3 SPECIFICATIONS B 3 1 Autoread Plus Analyzer p n 429576 Electrical Inputs 16 5 VDC 12 5 VDC 20 VDC Refer to diagram in Figure 3 13 Section 3 Display Reflective type Liquid crystal Operating Temp with QBC Tubes 68 F to 98 F 20 C
72. routines from the optical characteristics signature of the inserted tube IMPORTANT Before patient hematology tests the operator can program a sex specific adult normal range or pediatric normal range from a menu of 12 range selections If the operator fails to select a specific normal range test results will appear on bar graphs showing adult male and female normal ranges The OPTIONS MODE is for previewing the display languages setting the calendar clock and print format and identifying the installed software cartridge The baud rate option function is for computer interfacing 3 1 4 Transport Mechanism The tube loading platform Figure 3 6 is designed so that an inserted tube will roll unaided into a slot and down into the transport carriage Subsequently the tube is colleted or clamped in the carriage The transport mechanism Figure 3 7 consists of a metal carriage supported by a lead screw and guide rod and driven by a stepper motor The motor is capable of a linear resolution of 0 000625 inches per step In conjunction with the fluorodetector system the transport unit functions as a precision optical micrometer CBC MODE Insert QBC Tube CAL CHECK MODE Insert Cal Rod CONTROL MODE Insert QBC Tube OPTIONS MODE Select A Figure 3 6 Placing Tube onto PLATFORM Loading Platform CARRIAGE LEAD SCREW STEPPER MOTOR Il HO B A I t
73. s the calibration check rod must be tested in order to verify satisfactory analyzer performance Calibration check results are displayed on bargraph pictograms see Figure 2 8 and immediately show whether the calibration test is acceptable Note Daily testing with QBC Hematology Control and other quality assurance procedures are described in Section 4 5 of this manual 2 7 PACKAGE INSERT QBC AUTOREAD AUTOREAD Plus CALIBRATION CHECK ROD A PERFORMING DAILY CAL CHECK LU SHIPPING VIAL CAL CHECK ROD Figure 2 7 Calibration Check Rod for Autoread Plus Analyzer MESSAGES CAL CHECK MODE Insert Cal Rod QBC AUTOREAD Plus HEMATOLOGY ANALYZER Date JUNE 11 1996 Time 11 51 Calibration Check Rod Factory Calibration Ranges Low 235 14 33 1 35 7 10 5 g d 9 2 11 4 29 9 gek 23 7 30 8 17 8 x10 L 15 6 19 5 1 Acceptable High Figure 2 8 Printout of Typical Calibration Check Rod Test 2 6 2 Use continued As shown in Figure 2 9 a slot located directly behind the loading platform of the instrument is provided for storage of the calibration check rod STORAGE SLOT FOR CAL CHECK ROD Figure 2 9 Platform Door Opened Showing Calibration Rod Storage Slot 2 8 3 1 AUTOREAD PLUS ANALYZER 3 1 1 General Description The QBC Autoread Plus analyzer is a slim compact instrument housed in a sturdy 4 piece enclosure Figure 3 1 Figure 3 2 shows t
74. s have been observed at bilirubin concentrations up to 8 5 mg dL 9 eCoumadin Anticoagulant therapy has been Appendix A 1 shown to have no clinically significant effect on performance 9 e Doxorubicin Treatment with the anthracyclic drug Doxorubicin does not appear to interfere with the QBC test method 9 Drugs The effects of other potentially interfering drugs and their metabolites on QBC tests have not been established 10 11 Specimen Storage and Stability After collection anticoagulated venous blood may be held in the collection tube at room temperature 68 to 90 F 20 to 32 C for the times indicated below eUp to 90 minutes from blood collection provided all parameters including the platelet count are required Specimens more than 90 minutes old may yield falsely elevated platelet counts Note After centrifugation QBC Tubes may be tested up to 4 hours later Up to 4 hours from blood collection provided all parameters except the platelet count are required Note After centrifugation QBC tubes may be tested up to 4 hours later Filed QBC capillary blood tubes should be mixed and centrifuged promptly after blood collection Blood specimens may contain the Hepatitis B Virus HBV Hepatitis C Virus HCV Human Immunodeficiency Virus HIV or other disease causing agents Handle all patient specimens as potential biohazards capable of transmitting infection Wear appropriate personal protecti
75. ter ZBI Notes to Table A 2 2 1 Reference methods ULTRA FLO 100 Platelet analyzer and Coulter Model S analyzer 2 Reference methods Coulter ZBI analyzer and Coulter Model S analyzer The MCHC value displayed by the Autoread Plus analyzer is electronically calculated from the hemoglobin and hematocrit by the standard formula of derivation MCHC was compared with values obtained by a Coulter analyzer and a manual method as reference The correlation study involved 196 venous specimens Due to the numerically narrow range of the MCHC parameter neither of the automated test procedures QBC analyzer or Coulter analyzer correlated perfectly with the reference method however MCHC by the QBC analyzer correlated as well with the reference method as the Coulter analyzer Table A 2 3 Table A 2 3 CORRELATION MATRIX MCHC 196 Specimens QBC Coulter Reference QBC 1 0 Coulter 0 6762 1 0 Reference 0 6727 0 6859 1 0 A 2 4 Appendix B Service Maintenance and Specifications B 1 INTRODUCTION Service and maintenance procedures for the QBC Autoread Plus System approved for use by the customer are limited to the items described in this Appendix DO NOT ATTEMPT ANY OTHER SERVICE OR REPAIRS Appendix C contains a list of replacement parts and accessories available through your QBC distributor B 2 SERVICE AND MAINTENANCE B 2 1 Autoread Plus Analyzer There are no customer serviceable parts on the Autoread Plus analyze
76. to closure D2 Manually twist and firmly push on closure to form leak tight seal E Be sure closure is completely seated and properly aligned Failure to align and seat closure properly may result in blurred interfaces With 424241 Tray Slide unsealed end of tube over tip of pre positioned float F1 and push until float is inside tube Gently lift closure end of tube until float releases from its tray slot Raise unsealed end of tube slightly above horizontal to prevent float from falling out If necessary press float against clean surface to push end into tube NOTE Never touch float with fingers or gloves Use the forceps to handle loose or dropped floats With 424238 Box Using forceps supplied with analyzer pick up float from test tray well Insert forceps held float into unsealed end of tube F2 With forceps tap float into tube Never touch float with fingers Note After inserting float tubes can be held for centrifuging provided they are stored vertically closure down in workstation A maximum of 15 minutes is allowable between insertion of float and centrifugation A 1 5 CAUTION Do not force closure onto tube Tube is made of glass and may break Step 3 Centrifuge for 5 Minutes Place blood tubes in QBC Capillary Centrifuge Spin down according to instructions in centrifuge manual When centrifugation is complete promptly remove tubes Time Delay Between Completion of Centrifugation and Tub
77. ty MI 49686 800 333 0958 www api pt com e American Academy of Family Physicians AAFP PT Program Coordinator 11400 Tomahawk Creek Parkway Leawood KS 66211 800 274 2237 www aafp org e American Association of Bioanalysts AAB 205 West Levee Brownsville Texas 78520 800 234 5615 www aab org 4 9 American College of Phycisians ACPS 2011 Pennsylvania Ave NW Suite 800 Washington D C 20006 800 338 2746 www acponline org College of American Pathologists CAP Surveys Department 325 Waukegan Road Northfield Illinois 60093 800 323 4040 WWW Cap org 4 6 OPTION FUNCTIONS The OPTIONS MODE is accessed by means of the MODE key Use the 4 or key to scroll through the menu of options shown opposite The first three functions are described earlier in Section 2 4 2 2 4 4 of this manual The CARTRIDGE TYPE function may be needed in connection with service problems Before requesting technical assistance on any problem relating to the analyzer obtain the identification number of the installed software cartridge by accessing the CARTRIDGE TYPE function then press the NEXT key and record the software version number Note The software number is also displayed during the start up routine and appears on the software cartridge label See Section 2 5 1 for a description of the SET BAUD RATE option To exit any option function press MODE to advance the display to the primary CBC MODE 4 7 QBC CAPIL
78. ual for additional information in these cases If the printer is connected and On Line a printout of test results is initiated simultaneously with the display of test results on the front panel Contents of the printout are determined by the format programmed earlier Section 2 4 4 i e eTest Values Only e Test Values plus Short HDR e Test Values plus Long HDR No Printout Page or Label Notes 1 If printing format was not pre programmed the printout will contain only test values 2 No HDR report is printed for pediatric tests MESSAGES CBC MODE Insert QBC Tube A Insert Tube MESSAGES CBC Mode Close Door l Close Door MESSAGES Assay in Progress MESSAGES d Scanning Cap Scan 1 m MESSAGES j Scanning Float can Repeats a and b for Scans 2 8 b LO na MESSAGES Scanning Complete MESSAGES d Analyzing Scans Scan Repeat for Scans 2 8 d HEMATOCRIT HEMOGLOBIN IO CONTRAST LYMPH MONO 10 L e WBC 10 GRANS LYMPH MONO MESSAGE MCHC 32 b g dL AccuTube Sample Figure 4 4 Sample Panel Display of Test Values 4 2 3 Hematology Printouts continued The example in Figure 4 5 shows test results printed numerically and in bar graph form on the normal range programmed as described in paragraph 4 2 1 On all test result printouts spaces are provided for recording the patient s name date of birth and accession or ID number Note In th
79. ube breaks carefully pick up broken glass with a hemostat or other device using puncture resistant utility gloves f a tube breaks inside the centrifuge wipe the head and interior of the cover clean with a cloth and a 1 10 dilution of chlorine bleach Allow to dry Note Do not pour water or bleach solution into the centrifuge itself f a tube breaks inside the analyzer remove the waste tray below the loading platform and discard any broken glass Clean the waste tray with a 1 10 dilution of chlorine bleach then rinse with water and dry 4 15 Section 5 Specimen Collection and Preparation for Testing 5 1 VENOUS BLOOD FOR HEMATOLOGY Draw venous blood into collection tubes containing the anticoagulants disodium or tri potassium ethylenediamine tetraacetate EDTA 5 1 1 Collection Procedures eBe sure to wear laboratory gloves Use only clean glassware and sterilized collecting instruments Before venipuncture clean the skin area with an antiseptic agent and wipe dry eDraw venous blood with a Vacutainer brand blood collection tube or other blood drawing device containing EDTA To assure an acceptable blood to anticoagulant ratio fill the collection tube to at least 2 3 of its fill volume Remove the collection needle and dispose properly in a sharps container e Thoroughly mix the blood with the anticoagulant If clots are present discard the specimen 5 1 2 Anticoagulants Always anticoagulate ve
80. usa Rot DE 2 5 ZAM Setting Printout Format EE 2 6 SETTING BAUD Fate tono pectet nu idea odo Ru xg clin dt ducc ed ade addu EEEa 2 7 CALIBRATION CHECK geegent eege 2 7 PAM eget 2 7 PAIAMEELIGNC Let 2 7 Section 3 PRINCIPLES OF OPERATION 3 1 AUTOREAD PLUS ANALY EES 3 1 CO D WE ERT EE 3 1 3 1 2 Display Panel uuu tein incest dara ritas ee eaae titre isa eene Idae atn 3 2 3 1 8 Function Keys and Modes sese 3 2 3 1 4 Transport Mechanisrn u uu uuu tiic deele eene diuo 3 3 5 cc 3 4 316 eee u uuu e aa E aea neadan a eaa EER TTE 3 5 SL Data ACQUISIION E 3 6 3 1 8 HDR Analysis Hepott uuu ul u u u Ee Eege 3 7 AUTOREAD PLUS POWER PACK scccteatadesitecsnosavitsanensaduwteds serenstadanentaceatncauacdeaae 3 7 QBC CAPILLARY CENTRIFUGE u uuu uu u u dius a Reda Drusi 3 7 PRINTER fee 3 8 WORKSTATION EE 3 8 VENOUS BLOOD PIPED WER E 3 8 SPECIFICATIONS geegent 3 8 Contents continued Section 4 OPERATING PROCEDURES 4 1 STARTING ANALYZER u c a EE Ea a AAE EEEE 4 1 AAT Power On SGM CMEC EE 4 1 402 Mod Se el ctionmu uuu u u uu u uu u u EE EA EREET 4 2 4 1 3 Pre Test Performance Check 4 2 4 2 el Suter 4 2 4 2 1 Selecting Patient s Normal Range 4 3 4 2 2 Starting a ASSAY eeen Qoi ee Lacinia cosa Dra nedum 4 3 2 2 3 Hematology
81. ve equipment including gloves when collecting and processing blood A 1 3 1 Procedures with Standard QBC Venous Tubes Note Handling differences illustrated in the procedures that follow are due to differences between the 100 Test p n 424240 and 1000 Test p n 424237 QBC Venous Tube packaging IMPORTANT For directions on opening and closing the barrel of the QBC pipetter refer to Section 4 8 Step 1 Fill and Seal Blood Tube With barrel in open position and pipetter horizontal gently insert end of tube nearest red lines into QBC pipetter close barrel by twisting backward Depress plunger of pipetter then insert distal end of tube into specimen of well mixed anticoagulated venous blood A Smoothly but quickly release plunger of pipetter to fill tube With tube horizontal check that blood level is within 1 mm of black fill line Carefully wipe outside surface of tube with lint free tissue With 424240 Tray Press distal end of tube firmly into closure in tube tray B1 Twist pipetter slightly to be sure that closure remains on tube when pipetter and tube are lifted Open barrel of pipetter and remove tube or With 424237 Box Remove closure from test box Press distal end of blood tube into closure B2 Twist pipetter slightly to be sure that closure remains on tube Open barrel of pipetter and remove tube Manually twist and firmly push on closure to form leak tight seal see C next page Be sure closur
82. ws with the MCHC parameter displayed simultaneously on the first line of the MESSAGES readout the type of QBC tube AccuTube venous or capillary is displayed on the second line of the readout 3 1 3 Function Keys and Modes The four function keys located in front of the loading platform Figure 3 5 are tactile type switches with embossed circular faces Key functions are described below e MODE key accesses the testing programs and non testing options e NEXT key to access the printing function and initiate a reprint to perform various routines as defined by the displayed message and to advance the current display e 4 key increases program numbers in setting date time etc Also performs other functions defined by message routines e key decreases program numbers Also performs other functions as defined by message routines HEMATOCRIT HEMOGLOBIN g dL POWER WBC 10 L PLT 10 L GRANS GRANS 1091 CONTRAST Se LYMPH MONO LYMPH MONO 10 L o MESSAGES MCHC 32 b g dL AccuTube Sample CONTRAST Figure 3 4 Display Panel with Typical Results 3 2 Figure 3 5 Four Switch Keyboard Pad 3 1 3 Function Keys and Modes continued There are four main operating modes three of which are for testing and the fourth for selecting options see displays opposite Once programmed to a test mode the instrument automatically determines the correct algorithms and processing
83. y stored tubes can also result in non reported results Practitioners must not assume that unreported values are normal further testing with an alternative method is essential Automated granulocyte and lymphocyte monocyte differential counts cannot replace the conventional manual differential Due to grouping by density of the cell populations by the QBC system method the system cannot discriminate between normal and abnormal cell types in disease states characterized by the presence of abnormal white cell types or nucleated red blood cells If abnormal cell populations are suspected verification of QBC test results or testing and diagnosis by alternative methods is essential The combined lymphocyte monocyte count should not be used to test for lymphocytopenia in evaluating patients with known or possible immuno deficiencies Further evaluation of lymphocyte monocyte counts in relevant situations must include a manual differential and lymphocyte subset analysis A 2 2 A 2 3 EXPECTED VALUES The following table provides normal ranges reported in the literature 1 12 Offices or laboratories may choose to develop normal hematology ranges based on the characteristics of their patient population Parameter Range Hematocrit Males 42 50 Hematocrit Females 36 45 Hemoglobin Males g dL 14 18 Hemoglobin Females g dL 12 16 MCHC g dL 31 7 36 0 Platelet Count x 109 L 140 440 WBC x 109 L 4 3 10 0 Granulocyte Count x 109
84. yzer as shown in Figure 4 3 i e with the closure or stopper facing left and the open end facing the optic compartment 4 2 HEMATOCRIT HEMOGLOBIN ot WBC 10 L GRANS 10 LYMPH MONO CONTRAST LYMPH MONO 10 L 9 MESSAGES CBC Mode Insert QBC Tube E Figure 4 2 Panel Status for Hematology Testing CLOSURE OR STOPPER Figure 4 3 Correct orientation for inserting QBC Blood Tubes 4 2 1 Selecting Patient s Normal Range For a printout of test results superimposed on a pictogram of the normal hematology range of the patient program the applicable normal range into the analyzer before running each test as described below With the display reading CBC MODE as shown opposite use the 4 or key to scroll through the following menu of sex specific adult or age specific pediatric normal ranges Adult Female Adult Male Age 6 Years Puberty eAge 2 6 Years eAge 6 24 Months eAge 2 6 Months eAge 4 8 Weeks eAge 1 4 Weeks eAge 2 7 Days eAge 24 48 Hours eAge 12 24 Hours eAge 0 12 Hours Pediatric When the desired range is on display close the loading platform door to start the assay If the loading platform door is closed without making a normal range selection the adult male and female normal ranges will both appear on the printout IMPORTANT Selection of any of the pediatric normal ranges will prevent printout of hematology diagnost

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