Home

ABL90 FLEX operator`s manual

1. Biological risk Consult accompanying documents Waste electrical and electronic equipment e Radiometer Medical ApS and its distributors within the European Union and associated states have taken the necessary steps to comply with the directive 2002 96 EC on waste electrical end electronic equipment WEEE e The instrument when reaching its end of life must be collected and recycled separately from other waste according to national requirements Please contact your local Radiometer distributor for instructions Environmental implications WEEE contains materials that are potentially hazardous to the environment and to human health o IOO Mark of compliance with applicable EU Directives In vitro diagnostic use Manufactured by 1 6 ABL90 FLEX operator s manual 1 Introduction Explanation Syringe position of inlet Sample mixer Capillary position of inlet 1 7 1 Introduction ABL90 FLEX operator s manual Symbols used in this manual Definitions The manual contains operational warnings and cautions which are important and should be read carefully before performing the related procedures The manual also contains important information and a number of helpful hints signaled by the word NOTI CE Explanation Symbol A WARNI NG A warning alerts the reader about a situation which if not avoided could result in death or serious injury It may also describe potential serious adverse reaction
2. Suggestions to preventive measures Use two patient identifiers Ensure that the sampler has an ID label attached when you leave the patient Always enter patient ID into the analyzer Prebarcoded arterial blood gas samplers are available from Radiometer Inform the patient of the procedure in order to avoid hyperventilation Sample at least 20 minutes after ventilatory adjustment Use heparin in sufficient concentration The recommended concentration depends on the specific blood sample Samplers with different heparin concentrations are available from Radiometer Use electrolyte balanced heparin when electrolytes are to be reported Samplers preheparinized with electrolyte balanced heparin are available from Radiometer Use preheparinized devices with dry heparin available from Radiometer Discard a sufficient volume from the catheter before taking a blood sample CLSI recommends a flush volume of 6 times the dead space of the catheter 1 Stop infusion for a period of time or use another sampling site ABL90 FLEX operator s manual 12 Sampling Cause of Possible Suggestions to preventive measures error problem Capillary Biased results samples likely on all parameters Air bubbles in All parameters sample affected by air bubbles in the measuring chamber Clots in sample Biased results likely on all parameters Hemolysis Bias on electrolytes especially cK The need for heel warming
3. Change if necessary the End date by highlighting it and typing in a date other than the current date Confirm with Enter Select the desired calibration type and status using the relevant arrow buttons Confirm each entry with Enter or Select Press Apply to start the search filter View the search results on the screen Press Back to return to the previous screen ABL90 FLEX operator s manual 9 Data management Trend function This function is used to make the trend of the selected parameter for a calibration after the filter criteria have been applied 3 12 2009 02 10 PM 3 12 2009 02 10 PM 3 12 2009 02 10 PM 3 12 2009 02 09 PM 3 12 2009 02 09 PM 3 12 2009 02 09 PM 3 12 2009 02 09 PM 3 12 2009 02 09 PM 3 12 2009 02 08 PM BG Elec Met pH BG Elec Met pH BG Elec Met pH BG Elec Met pH BG Elec Met pH BG Elec Met pH BG Elec Met pH BG Elec Met pH BG Elec Met pH g 8 7 6 5 4 3 2 1 En Resmi alten EPA mend SS Fint Step Action 1 Set up search criteria as described under Filter function and apply them The filtered calibration results will be displayed and Trend and Print will now be active 2 Press Trend to select the parameter 3 Press View trend to display the trend of the selected parameter for the selected calibration type 4 Press View filter to view the selected filter criteria the criteria cannot be changed only viewed To apply new criteria repeat the Fi
4. Blinking green 1D The analyzer is connected to mains 90 fo The battery is charging Blinking yellow The analyzer is running on battery steadily If battery charge level lt 25 A system message is shown in the Activity log The battery charge level in the icon of the battery level indicator is yellow Corrective action Connect the analyzer to mains Blinking intense The analyzer is running on battery yellow If battery charge level lt 13 A message is shown on the screen The battery charge level in the icon of the battery level indicator is red Corrective actions Connect the analyzer to mains Close the dialogue box If battery charge level lt 10 the analyzer automatically performs a controlled shutdown Corrective actions Connect the analyzer to mains Turn on the analyzer Battery specifications Battery operation Approximately 1 hour of battery power when analyzer is in Ready mode or approximately 25 samples Battery pack charge Approximately 90 minutes to fully charge a depleted battery time pack Technical Data in this document will be added to the manual next time it is updated documentation Radiometer Medical ApS Akandevej 21 2700 Br nsh j Denmark www radiometer com Table of contents ABL9O FLEX 1 Introduction 2 What is what 3 Analyzer status A Sample measurements 5 Quality management 6 Calibration
5. Department Pat ICU Patient note Birth weight Gestational age kE TREGUES ano 3 Step Step 0 D Action Highlight the desired patient profile and press Edit on the Patient profiles log screen e Use a barcode reader see Barcode reader in section Hardware chapter 2 What is what in this manual to scan the patient data that are supported by the barcode the Enable general barcode support should be activated in the Miscellaneous setup see the procedure in Entering information with barcode reader chapter 4 Sample measurement section Entering patient identification in this manual Or e Request if connected the data from the LIS HIS system by verifying the patient ID and pressing Request Highlight an item using the up down arrows and type in the data using the screen keyboard or keypad Confirm each entry with Enter or Select When completed press Back to return to the previous screen Action Press Add on the Patient profiles log screen Follow steps 2 4 in the Editing a patient profile procedure to add a new patient profile Action Highlight the desired patient profile on the Patient profiles log screen Press Delete 9 7 9 Data management ABL90 FLEX operator s manual Finding a Step Action atient profile pan pai 1 Press Find on the Patient profiles log screen 2 e Highlight the search criterion and enter the data using the screen keypad or keyboard Confirm with the En
6. Elec Met pH BG Elec Met pH BG Elec Met pH BG Elec Met pH BG Elec Met pH BG Elec Met pH No Aa a ODN 0 PR RESTE A zilar E iene lt Prini Each report is identified as follows use the left right scroll bar to see the items Date and time that the calibration was performed The ID number of a performed calibration Indicates the calibration type See chapter 6 Calibration Status Indicates the calibration status OK a successful calibration an error detected or a measured value exceeded a range of indication Aborted a calibration stopped by the analyzer most likely due to missing calibration solution The following functions are available by activating a button Displays the highlighted patient report see chapter 4 Sample measurement for detailed information Is inactive until the filter criteria are chosen and applied see below Starts printing the list is active only after filter criteria have been applied Returns to the main screen 9 Data management ABL90 FLEX operator s manual Filter function The function is used to set the filter criteria to find a calibration or to select a number of calibrations 9 10 2009 Type Status 9 17 2009 Calibration tHb calibration Selert Action Set the Start date use the 1 day 7 day 14 day or 30 day icons in the Criteria box or type in the date using the keypad and confirming the entry with Enter
7. Operator s 7 Replacements manual From software version 2 8xx 8 Disk functions 9 Data management 10 Analyzer shutdown 11 Troubleshooting 12 Sampling 13 Specifications 14 Ordering information IVD Index RADIOMETER R Date of issue System performance The procedures described in this manual must be observed in order to ensure proper system performance and to avoid hazards Radiometer cannot provide or verify system performance characteristics if the system is not installed used and maintained in accordance with Radiometer procedures or if accessories not meeting the specifications provided by Radiometer are used Radiometer warrants that the data media on which the software included in the system is furnished is free from defects in material and workmanship under normal use for three 3 months from the date of delivery as evidenced by a copy of invoice or receipt Third party software and trademarks The ABL9O FLEX analyzer comprises the Microsoft Windows XP Embedded and Sybase SQL Anywhere software By using the system you accept the terms of the Software License Agreement s of the provider s of the above software as shown in the End User License Agreement s included in this manual If you cannot accept the terms of the Software License Agreement s you should not use the system but Immediately contact your provider for a return of the system and a refund of the purchase price Microsoft and Windows ar
8. The information provided by the acid base chart should only be used as a guideline for interpreting the patient s condition Patient results must always be examined carefully by a clinician before a diagnosis is made 4 Sample measurement ABL90 FLEX operator s manual Patient result audit trail Any changes made on the Patient identification screen will be registered in the audit trail function The audit trail contains information about the operator who made the change time of change and new old values changes made at the same time are indicated with in the Time and User columns Messages on the screen is substituted with Log to indicate that changes were made Step Action 1 Press Log on the Patient result screen to display the following buttons Audit trail and Messages Press Audit trail Use the up down arrows to scroll the list of changes Press Back to return to the Patient result screen ABL90 FLEX operator s manual 4 Sample measurement Patient result messages Screen Press Messages on the Patient result messages screen messages g The Patient result messages screen gives the erroneous parameter s and the message s with number s Messages can be seen on the following three levels User Messages for the user familiar with the basic daily operation of the analyzer and primarily responsible for performing measurements This level displays the fewest messages Manager Messages for the user with a
9. see Operator actions in case of error in section General information in chapter 11 Troubleshooting in this manual and chapter 10 Analyzer messages in the ABL9O FLEX reference manual 3 7 3 Analyzer status ABL90 FLEX operator s manual 3 8 4 Sample measurement General IMtORNatO Asensi d ate entidad 4 2 Immediately before analySiS 20 iii dd IA 4 3 Introducing a blood sample with a standard SyrinGe cccccceeeeeeeeeeeeeeeeeeeees 4 4 Introducing a blood sample with a safePl CO sampler with barcode 4 5 Introducing a blood sample with a safePl CO sampler with barcode and sample Drea cds tract tes tad e ence ee ios tube ie cala oriol 4 6 Introducing a blood sample with a capillary tube o o oooccccccccccccccccccnnnnnn cnn 4 8 Introducing a blood sample with a test tube oooccccccccccnnccnccnnnnnccccnnn ars 4 9 Entering patient identifiCatiON ooccocccccccccccccnnnncccnnnarcn cnn nn nn 4 10 Paent rosu ona de de cl 4 14 Patient result MESSAGES uri A A 4 19 4 1 4 Sample measurement ABL90 FLEX operator s manual General information Available modes and parameters 4 2 The modes and the measured parameters available on the ABL9O FLEX analyzer are listed below Syringe S 65uL pH pCO pO2 ctHb sO2 FO2Hb FCOHb FHHb 2 E Capillary C 65uL FMetHb FHbF cK cNa cCa cC cGlu cLac Ampoule QC All available NOTICES Not all of the above parameters may be av
10. 1 5 mL 100 units safeP CO Self fill with needle shield device and 956 616 safeTIPCAP 23G x 1 0 7 1 5 mL 100 units safeP CO Self fill with needle shield device and 956 620 safeTIPCAP 22G x 1 0 7 1 5 mL 100 units safePICO aspirator 0 7 1 7 mL 100 units 956 622 ME With needle cube 14 6 Index A ABL90 FLEX analyzer documentation 1 2 ACCESS FIQNtS cccccceeeeeeeeeeeeeeaes 2 18 Acid base chart cccccceeeee eee 4 17 CLIN IR TOO r e 9 18 adding Message coocccconnncccannn nn 9 18 filter function aia 9 19 Adding a message to the log 9 18 ANAalYSIS CheCK taaan ana 5 8 Analyzer da e E 7 16 SICA OW Mr besch aa aaia 10 1 Analyzer exterior CVS ANG A 7 16 Analyzer requirements 00000e 13 5 Analyzer screen CO AMIA seria iras 7 17 Analyzer shutdown 00ccccccccnncccncnoo 10 1 general information 0006 10 2 long term Shutdown 0c0008 10 6 LOG FOS ias 10 2 restarting after temporary SHULAOWicdacectdetetodedn cited 10 4 restarting the analyzer 10 7 STORING A abun sae eee ee bee aa 10 7 temporary Shutdown 006 10 3 transporting analyZer 00 10 7 Analyzer specifications 13 6 Analyzer Startup ccccceceeeeeee ees 2 18 Analyzer StatuS cccceeeeeeeeeeeeeees 3 1 A Aan ar EANA 3 2 Cal Raco atando A 3 4 other activities oooooccccccccncncconos 3 7 quality CONtTrOl oocccccccccccc
11. CLANES vta deidad isa 3 2 Analyzer status elements ii A A dd 3 3 Calbratlion Status manito alitas 3 4 Quat CONTO OC artis ni AA a 3 5 Replacements iaa a a aa 3 6 ORNGP a CUISINE AE T A EET 3 7 System MESSI DOS iu tiara as a es 3 7 3 1 3 Analyzer status ABL90 FLEX operator s manual Analyzer status at a glance 3 2 The working condition of the analyzer is continuously monitored during its operation To evaluate the analyzer status at a glance before a measurement use the following e Parameter bar e Color of the traffic light on the Analyzer status button Analyzer status button Analyzer 24 status as un Data logs O_Hb COHb MetHb HbF HHb K ABLSO Y y Logof 11 31 Pm Radiometer RADIANCE To enter the Analyzer status screen press Menu gt Analyzer status or press the Analyzer status button to access the analyzer status directly ABL90 FLEX operator s manual 3 Analyzer status Analyzer status elements The black triangle indicates that this is active F Calibrations calar k Calibration 10 29 AM 04 00 AM 9 9 2009 12 8 2009 3 months Silin cantia irr Oe Henlbcements Dinar Aras NAS orar Sy ie SSeoes Anar ee 7 A RESME A callar rd Z The traffic light color of the Analyzer status button is determined by the traffic light colors of the following status elements Calibrations GREEN OK YELLOW Error s in the last calibratio
12. Entering patient identification in this chapter 4 15 4 Sample measurement ABL90 FLEX operator s manual Patient result approval Result approval is possible if the Enable patient result approval check button has been activated in the Miscellaneous setup and only if the analyzer is set up to LIS HIS see section Miscellaneous setup in chapter 1 Setup in the ABL9O FLEX reference manual Step Action 1 Press Approval on the Patient result screen to display the following functions 2 e Approve Press Accept to accept the result and to send it to the connected LIS HIS Press the Keyboard icon to write a note Press Cancel to return to the previous screen e Reject Press Accept to reject the result and to send it to the connected LIS HIS Press the Keyboard icon to write a note Press Cancel to return to the previous screen e Rerun Press Accept to mark that the measurement Should be repeated and to send it to the connected LIS HIS Press the Keyboard icon to write a note Press Cancel to return to the previous screen e Note Press the Keyboard icon to type in a note prior to the approval or to edit a highlighted note To delete a highlighted note press the Keyboard icon and delete the note NOTICES e Once the result has been approved rejected rerun the ID data can only be viewed not changed grayed out input boxes The Parameters Patient lookup and Request buttons will not be available either e In the
13. F or min HO5VV f or min HO5VVH2 F rated min 60 C 2 x 0 75 mm Provided with a molded grounding type attachment plug rated min 250 VAC min 2 5 A Opposite end terminates in molded IEC 320 style connector rated min 250 VAC min 2 5 A e External computing devices connected to the equipment must comply with the standard UL 60950 for US and IEC 60950 for Europe Failure to do so may result in equipment damage e The mains supply cord and plug of the equipment must comply with any national regulation Failure to do so may result in equipment damage CAUTI ON Outside patient environment place the ABL90 FLEX analyzer minimum 1 5 meters from patient bed 2 5 2 What is what ABL90 FLEX operator s manual Inlet module 4 1 Symbols on the inlet cover that illustrate inlet handle positions 2 Handle that is lifted into syringe or capillary position before measurement 3 Holder with inlet gasket for sample aspiration syringe capillary test tube or QUALICHECK adapter 4 Inlet handle position LEDs 2 6 ABL90 FLEX operator s manual 2 What is what Built in sample mixer 1 Built in sample mixer If a safePICO sampler is placed in the sample mixer the ABL9O FLEX analyzer will automatically mix the blood sample Only safePICO samplers can be mixed in the sample mixer 2 7 2 What is what ABL90 FLEX operator s manual Barcode reader 2 8 de 1 Barcode reader Hold the barcode pa
14. OK a successful measurement e an error detected or a parameter exceeded the reportable range Interrupted a measurement stopped by the operator Aborted a measurement stopped by the analyzer most likely due to insufficient sample Patient ID Patient identification number Patient s last name 9 3 9 Data management ABL90 FLEX operator s manual Functions The following functions are available by activating a button Displays the highlighted patient report see chapter 4 Sample measurement for detailed information Is inactive until the filter criteria are chosen and applied see below Filter function The function is used to set the filter criteria to find a patient report or to select a number of patient reports 9 10 2009 9 17 2009 Patient ID Ss Patient Last name Patient first name Sex Date of birth Patient note Department Pat Accession No Sampler ID Sample type Sample site Draw time Step Action 1 Set the Start date Use the 1 day 7 day 14 day or 30 day icons in the Criteria box or type in the date using the keypad and confirming the entry with Enter 2 Change if necessary the End date by highlighting it and typing in a date other than the current date Confirm with Enter 3 Use the up down arrows to highlight the desired filter criteria Press More to display more filter criteria note that the right side of the screen changes to show choices f
15. Shows the number of remaining tests and activities Parameter status is okay no problem detected on the given measuring channel Error associated with the given parameter during the last calibration or quality control measurement The parameter is unreliable and will have a in front of the result if requested in the Corrective actions program see section Corrective actions chapter 1 Setup in the ABL9O FLEX reference manual Serious error associated with the given measuring channel The parameter cannot be used at all and will be displayed as or a parameter was repressed in the Parameter setup program see section Parameters and input setup chapter 1 Setup in the ABL9O FLEX reference manual A parameter disabled in the Parameter setup program will be removed from the parameter bar see Disabled versus deselected parameter in section Analysis setup in chapter 1 Setup in the ABL9O FLEX reference manual The buttons can be selected in the Access profiles setup programs together with the access profiles for each operator for detailed information see the description in Access profiles in section Analyzer security in chapter 1 Setup in the ABL9O FLEX reference manual 3 12 2009 02 10 PM 3 12 2009 02 10 PM 3 12 2009 02 09 PM 3 12 2009 02 09 PM 3 12 2009 02 09 PM 3 12 2009 02 09 PM 3 12 2009 02 09 PM 3 12 2009 02 08 PM 3 12 PNN NNR PM 2 N Ww BUDA N WO Prof Test OK 3580 Smith Capillary OK 3579 Reid V
16. T 1 4 Restarting the analyzer 10 7 Result SELE E E E E EEEE E E EETA 4 14 S Sample handlin9 oooccocccccccccccn ooo 13 4 Sample measurement c cccccccccccnnncoso 4 1 available modes and parameters 4 2 blood sample with a capillary tube 4 8 blood sample with a safePl CO sampler with barcode 4 5 blood sample with a safePl CO sampler with barcode and sample pre registration 4 6 blood sample with a standard SVINGO rd dci 4 4 blood sample with a test tube 4 9 entering patient identification 4 10 immediately before analysis 4 3 patient result occcccccccccconnncnnos 4 14 test tube SamplesS cccceeee ees 4 9 Samplers recommended arterial blood SanPin aAA 12 2 recommended capillary blood Samplers irissat LL 12 2 sampling escran ehi iii 12 1 special considerations for capillary SpeciMenS cccceeeeeeeeeeeeeeees 12 3 storage recommendations for whole blood samples 12 5 storage tiMe ccccce ee eeeee ee eens 12 5 temperature recommendations 12 5 Sampling devices and procedures 12 2 Sampling Procedures ccceeeeeees 12 2 Screen main SEEN ana 2 11 Screen elements 2 11 buttom section ccc cece eee eee eee ees 2 16 DUELO Sada 2 16 center SECTION oooocccccccnnnnccnnnnos 2 12 information bar cc cece eee eee eee e ees 2 17 Interaction toolS cecene 2 13 Navigation to0lS ococ
17. The following functions are available by activating a button Next param or Displays other parameters starting with pH Prev param WDC report Displays the WDC report screen see Creating a WDC report in chapter 2 Disk functions setup programs in the ABL90 FLEX reference manual Print Starts printing the screen data see below A To delete the statistics of a slot solution Delete Back Returns to the Quality control log screen 9 Data management ABL90 FLEX operator s manual Printing QC statistics Step Action 1 Press Print on the Quality control statistics screen 2 e Activate Print lot to date and press Print to print QC statistics for an entire lot e Activate Print for period to print monthly QC statistics select the month and press Print de Press Back to return to the Quality control statistics screen 9 14 ABL90 FLEX operator s manual 9 Data management Calibration log Purpose The Calibration log is a historical file of calibrations automatically saved in the Calibration log after a calibration Each calibration report is listed as an individual record The reports are listed chronologically the latest report being at the top of the screen 3 12 2009 02 10 PM o BG Elec Met pH 3 12 2009 02 10 PM 3 12 2009 02 10 PM 3 12 2009 02 09 PM 3 12 2009 02 09 PM 3 12 2009 02 09 PM 3 12 2009 02 09 PM 3 12 2009 02 09 PM 3 12 2009 02 08 PM BG Elec Met pH BG Elec Met pH BG
18. a Worldwide DATACHECK report To make a backup of all data Data is stored as a backup at a designated location To restore a backup of all data files to the analyzer s internal disk from a designated location To export selected records from selected data logs To import externally archived data logs To export or delete archived data logs To save the current setup of your analyzer To load a previously saved setup NOTI CE Radiometer recommends that you only load a setup when the analyzer is in the Ready mode Otherwise this may result in a cold start For further information about cold starts see section Calibrations related to startups in chapter 6 Calibration To restore all or only some Radiometer default settings default setup For further information about the Disk functions setup programs see chapter 2 Disk functions setup programs in the ABL9O FLEX reference manual 8 2 9 Data management General iNO O Aecem E a E 9 2 Patient results osito 9 3 Patient protesis id ates o 9 6 Quat control lO escarlata Nos NA A aa 9 9 Cabra tOM G rra o a t 9 15 ACUI NOG dd weaatuecsaiinkseonelseuie 9 18 Replacement ironia reacia ea 9 20 Archived datalog A CON 9 21 RADIANCE DroWser optional usura liarla 9 23 9 1 9 Data management General information ABL90 FLEX operator s manual Access to data To access data logs press Menu gt Data logs logs Data log Patient results log Patient profiles lo
19. a green traffic light in the analyzer status ABL90 FLEX operator s manual 7 Replacements Printer paper Replacing NOTICE Avoid contact of paper with direct sunlight water high temperature printer paper and humidity alcoholic and organic solvents PVC containing materials freshly developed diazo copy sheets extensive pressure and scratching For storage use folders and cases made of polyethylene polypropylene polyester or similar material Step Action 1 Press Menu gt Analyzer status gt Replacements gt Replace gt Replace paper 2 Press the release button to unlock the lid Open the lid by pressing it backwards and remove any leftover paper from the printer 3 Place the new roll in the printer so that the paper unreels from underneath the roll Align the paper roll in the middle of the printer 4 Make sure that some of the paper will extend out of the printer when the cover is closed Then close the cover by pulling the cover forwards and pressing it down until a click is heard 5 Press Replaced to enter operator name and any notes using the Keyboard or the Note button to display the keyboard Confirm the entry with the Enter button on the keyboard 6 Press OK to exit to the main screen 7 9 7 Replacements ABL90 FLEX operator s manual Inlet Replacing the inlet Part Function 1 2 3 4 5 Holder with inlet gasket Inlet probe Inlet handle Black inlet connector Back p
20. a patient profile can be added to the log It is required to include patient data in the log before the patient pre registration function can be used The patient data recorded in a patient profile will automatically be used as soon as the patient ID number is entered on the Patient identification screen during a measurement Patient profiles The patient profiles are listed in the order they have been created log 9 6 Geller Male 3 13 1958 ICU 1 3 12 2009 02 10 PM Goodman Female 8 2 1970 ICU 3 12 2009 02 08 PM Goodman Male 6 14 1983 ICU 3 12 2009 02 10 PM Ray Female 11 15 1977 ICU 1 3 12 2009 02 09 PM Reid Male 10 21 1975 ICU 3 12 2009 02 09 PM Reid Male 7 25 1976 ICU 3 12 2009 02 10 PM Roy Male 9 18 1969 ICU 3 12 2009 02 09 PM Smith Male 10 30 1974 ICUd 3 12 2009 02 09 PM Smith Female 5 8 1968 ICU 3 12 2009 02 10 PM The following data can be entered in a patient profile use the left right scroll bar to see the items e Patient ID e Last name e First name e Sex e Date of birth e Department Pat e Patient note e Birth weight e Gestational age NOTICE If the analyzer is set up to request data from LIS HIS these data will always override those from the Patient profiles log ABL90 FLEX operator s manual Editing a patient profile Adding a new patient profile Deleting a patient profile Patient ID Last name First name Sex Date of birth 9 Data management Geller Monica Fernale 1 2 1980
21. analyze a mixed venous and an arterial or capillary blood sample from the ctO a v patient To obtain the calculated values of FShunt and ctO a v it is necessary Step Action 1 Make if required a new patient report layout see Patient report setup in section Analysis setup chapter 1 Setup in the ABL9O FLEX reference manual with the following parameters included e FShunt and or ctO gt a v into the Patient result e pO gt v sO gt v FO2 1 RQ and T patient temperature into the Patient ID 2 Analyze the mixed venous sample and record the pO v and sO gt v 3 Analyze the arterial sample 4 On the Patient identification screen select the sample type as Arterial or Capillary and key in the following values e pO2 v and sO2 v from the mixed venous sample step 2 above e FO I if it differs from the default value of 0 21 for FShunt e RQ if it differs from the default value of 0 86 for FShunt e T if it differs from the default value of 37 C for FShunt NOTICE The FShunt will be estimated if not all of the inputs sO2 v pOz v FO 1 RQ are given A default value for ctO gt a v will be used if pOz v as well as sO gt v are not input 4 Sample measurement ABL90 FLEX operator s manual Patient result Program Parameter status 4 14 The Patient result screen will be displayed automatically when the measurement has been completed However if the patient identificati
22. and sample pre registration 4 6 Introducing a blood sample with a standard Syringe cccceeeeeeeeeeees 4 4 Introducing a blood sample with a LOSE TUDE aos 4 9 INFO dU CHO Manaos 1 1 K Keyboard SCrE n ccceeeeeeeeeeeees 2 16 Keypad screen ccceeeeeeeeeeeeeees 2 14 L Limitations Of USO cccceeeeeeeeeeees 1 5 Logging system messages 11 3 Logs Activity IOC siria reviewers vans 9 18 archived Gal aiacissasemcscseatengsoces 9 21 calibration lOO usos 9 15 Patient profiles log o o 9 6 Patient results log9 oocoooococoo 9 3 Quality control log oooooo 9 9 M Mall Seress aaan 2 11 Manual QC measurement introducing QC solution 5 10 Manual QC results VIEWINO EE E E EE TT 5 11 Manual quality control 5 9 Manual release of the solution pack 7 5 Measured parameters 1 3 13 2 DO 13 2 Measurement FDR rar OS 1 5 SA luar riada 4 1 Menu SURUCKUNG conrarid idad 2 19 Messages patient resultS cccccccccccccconnnn caos 4 19 Mixing a blood sample IN a capilla yarei 4 3 4 8 E 4 3 in a testtibein ii 4 3 N NAMES aE a eta E 1 3 COMMON NAME cccccee eee eeeeaees 1 3 Proprietary NAME ccccceeee eens 1 3 Navigation tools cccceeeeeeneeeees 2 13 O Operator requirements 0ceee eee 1 4 Ordering informatiOn cceeeee 14 1 accessories analyzer 0
23. case the temperature is mandatory the result cannot be viewed until it is entered ABL90 FLEX operator s manual 5 Quality management Additional quality control If there is a need for more extreme QC values than those given in the built in QC system or in the manual QUALICHECK5 system it is recommended to use the Metabolite QUALICHECK solution As the analyzer software will not recognize Metabolite QUALICHECK solution as a control solution you have to select a blood mode before you introduce Metabolite QUALI CHECK solution into the analyzer 5 Quality management ABL90 FLEX operator s manual 5 14 6 Calibration General MALO ALO Araceli tecuricosa 6 2 LID Calor 6 4 Caprai TES E cnica obs 6 5 Calbration Verifica aria AN isa 6 8 6 1 6 Calibration ABL90 FLEX operator s manual General information Purpose Calibration programs Calling an unscheduled calibration Calibrations related to startups 6 2 The calibration process determines and checks the accuracy with which the analyzer measures its parameters The process is therefore important in ensuring the reliability of results Calibrations are performed with solutions and ambient air for each of the measured parameters All calibration results are automatically recorded in the Calibration log from which they can be viewed and printed See section Calibration log in chapter 9 Data management for details The calibration process and a detailed
24. deeper knowledge of the analyzer functions and responsible for the analyzer s proper operation Service Messages for the service technician with a thorough knowledge of the operation and construction of the analyzer This level displays the greatest number of messages and in most detail The following buttons are available Result Press to return to the Patient result screen Troubleshoot Press to display the error description operator actions and in some cases also a removal condition see chapter 11 Troubleshooting in this manual and also chapter 10 Analyzer messages in the ABL9O FLEX reference manual for detailed information Press to print out the screen message s Press to return to the previous screen Press to display the keyboard type the note and confirm with Enter If notes for patient result were entered in the User defined notes program see chapter 1 Setup in the ABL9O FLEX reference manual select a note from the list with the up down arrows To edit a note press Edit note and type the note on the keyboard Remember to confirm it with Enter on the keyboard To delete a note press Delete note 4 Sample measurement ABL90 FLEX operator s manual 4 20 5 Quality management Automatic quality management SysteM occccocccccccnnnnnncnnnnnnnncrcn nan 5 2 General INLORMaALION ai id tb is 5 3 BUE qUalty CONTO ds aria aba 5 5 SY SONT CHECKS a A ai 5 7 ANaly SIS CNO a a ido 5 8 Mantal QUalty C
25. from an analyzer setup different from yours 1 1 1 Introduction ABL90 FLEX operator s manual ABL90 FLEX analyzer documentation The documentation that accompanies the ABL9O FLEX analyzer includes practical and theoretical information regarding the function and use of the analyzer The table below describes documentation available for this analyzer Operator s manual Contains the instructions of use for point of care information e all the information required for everyday operation of the analyzer Describes the functions of the analyzer Reference manual Provides detailed information about the operating principles of the analyzer and contains reference material not required for the everyday operation of the analyzer Describes setup and the disk functions setup programs Describes the measuring and calibrating principles Lists all the parameters Provides the equations from which the derived parameters are calculated Provides information about how the performance of the analyzer is tested Explains error messages and gives troubleshooting procedures 1 2 ABL90 FLEX operator s manual 1 Introduction Names and intended use Names Intended use Proprietary name Common name ABL90 FLEX blood gas oximetry electrolyte and metabolite analyzer Blood gas oximetry electrolyte and metabolite measuring system The ABL9O FLEX analyzer is a portable automated analyzer that measures pH blood gase
26. from software version 2 8xx Publication 201303 Edition E Code number 995 656 1D Date of issue ABL9O FLEX operator s manual
27. opening for one measurement on one analyzer Action Check that the analyzer is in the Ready mode Lift the inlet to the syringe position Select Ampoule QC Place the adapter tip against the inlet gasket and press it upwards The probe extends into the ampoule and the QC solution is automatically aspirated NOTICE Be careful not to bend the probe Hold on to the adapter when removing the QC solution When prompted by the analyzer remove the adapter and close the inlet Dispose of used ampoules as infectious waste Clinical laboratory waste management CLSI document GP5 A2 Action Activate the Enable general barcode support check button in Miscellaneous setup if not already done Menu gt Utilities gt Setup gt General setup gt Miscellaneous setup Highlight the Operator field and scan Operator from your ID card see Barcode reader in section Hardware in chapter 2 What is what If the name is included in the list of the analyzer s registered users the barcode automatically will identify the person and fill in the name ABL90 FLEX operator s manual 5 Quality management Entering information manually View manual QC results Parameter status Step Action 1 Highlight the item to be edited using the up down arrows e The solution is entered automatically Choose the specific slot from the screen e Lot is entered automatically if only one lot for each solution is used Otherw
28. port 1 x RS 232 9 pin connector Baud rate 1200 2400 4800 9600 14400 19200 38400 115200 USB Universal Three connectors for USB port Serial Bus ports Ethernet 1 x RJ 45 connector 100Base Tx Fast Ethernet Keyboard mouse Keyboard PS 2 mouse interface External VGA Connector for VGA screen disabled in BIOS setting screen Built in thermal paper 112 mm wide Barcode reader Built in Reading distance 0 70 mm Bar width 2127 um 5 mil Number of characters lt 62 Code types Code 128 code 39 I2 of 5 Dimensions Height 45 cm 17 7 in with the vertical screen Width 25 cm 9 8 in Depth 29 cm 11 4 in Weight kg 11 1 with accessories 13 6 ABL90 FLEX operator s manual 13 Specifications Approvals and patents Approvals UL CSA In compliance with IEC 61010 1 Installation category Il CE mark Indicates compliance with the In Vitro Diagnostic Directive 98 79 EC EMC emission The equipment complies with the emission requirements for Class B equipment in EN 61326 1 Electrical equipment for measurement control and laboratory use EMC requirements part 1 General requirements EMC immunity The equipment complies with the immunity requirements in EN 61326 2 6 Electrical equipment for measurement control and laboratory use EMC requirements Part 2 6 Particular requirements In vitro diagnostic IVD medical equipment Patents Radiometer products may be covered by one or more patents and paten
29. sensor adjustment e Pump calibration e Rinse e Startup conditioning of the sensor cassette e Calibration When completed the main screen appears The analyzer can be used as soon as the analyzer is in the Ready mode and the traffic light of the Analyzer status is acceptable If the analyzer is turned off for a short period of time only and certain preconditions are fulfilled see below a warm start may be performed instead of a cold start With the warm start e The analyzer will be ready for measurement within approximately 10 minutes if the preconditions below are fulfilled e No calibration will be added to the measurement after restart e You can swap sensor cassettes during troubleshooting without calibrations being added to measurements e The user will be notified if the sensor cassette is not properly maintained no rinse or flush has been performed within the two hours If a sensor cassette has not been properly maintained it may take the sensors 24 hours to be ready for measurement or the sensor cassette may have to be replaced To initiate a warm start instead of a cold start certain preconditions must however be fulfilled e The analyzer must only have been turned off for a short period of time lt 120 minutes e The last cold start or sensor cassette replacement was not performed within the last 24 hours e The temporary shutdown feature should have been used for the shutdown The Standby button
30. should be performed by authorized personnel only To avoid the risk of infection always handle blood and the collection devices with care and avoid direct contact with the sample by using gloves A WARNING Risk of erroneous results Always meticulously follow the sampling procedures described in this chapter Failure to follow these procedures may introduce clots or air bubbles in the sample and yield erroneous results safePI CO Self filling arterial blood sampler for arterial puncture or A line Self fill sampling Prebarcoded with a needle shield device an integrated mixing device and a vented tip cap helping to ensure the best sample quality patient and operator safety safePI CO Aspirating arterial blood sampler for A line sampling Prebarcoded Aspirator and with an integrated mixing device and a vented tip cap helping to ensure the best sample quality patient and operator safety safePICO70 Self filling arterial blood sampler for arterial puncture or A line sampling with a needle shield device helping to ensure patient and operator safety PICO70 Self filling arterial blood sampler for arterial puncture or A line sampling PICO50 Arterial blood sampler for the aspiration of arterial blood from A lines CLINI TUBES are available in both plastic safeCLI NI TUBES and glass CLINI TUBES in a variety of volumes and with different types and concentrations of heparin Always make sure to use a capillary of sufficient vol
31. started at midnight bid If there is a sign of a clot in the analyzer during checks the following occurs e If the analyzer has removed the clot the analyzer goes into the Ready mode e If the clot is still there the analyzer goes into the Intervention Required mode Follow the on screen instructions to remedy the error or see the ABL9O FLEX operator s manual for further information about the Intervention Required mode The analyzer starts a system check if the clot was found during the system check at midnight Technical Data in this document will be added to the manual the next time the manual is updated documentation RADIOMETER Q Operator s manual Note to the users of the ABL9O FLEX analyzer Introduction This note to users describes the battery feature of the ABL9O FLEX analyzer Instructions to Please place this document in the binder of your manual user Brief overview 1 Battery pack The battery pack enables for a limited period of time the performance of measurements and the storage of data without the analyzer being connected to mains or during power failure Battery LED The battery level indicator on the screen The battery level indicator on the screen is only visible if the battery is installed The battery charge level is indicated by a percentage Battery LED Battery level indicator Constantly green JD The analyzer is connected to mains 100 Y The battery is fully charged 100
32. tasks to maintain and replace the Inlet the Inlet Probe the Inlet Gasket Holder and the Inlet Connector Gasket When the Troubleshooting needed screen is shown follow the instructions on the screen The analyzer will then guide you through the procedures In software versions up to and including 2 7 results that are outside the reportable ranges of the analyzer are shown without values on the Patient result screen and in printed results and no values are transmitted to connected LIS HIS systems This is still the default setting but in SW version 2 8 it is possible to get the exceeded range limit of the reportable range shown in the value field If e g the result is below the value which is the lower limit of the reportable range the result is shown as lt range The contents of this document will be added to the manual the next time the manual is updated Radiometer Medical ApS www radiometer com RADIOMETER Q Operator s manual Note to the users of the ABL90 FLEX analyzer Introduction This note outlines the improvements in software version 2 7 e Videos and text instructions will guide you through various troubleshooting procedures to solve fluid transport problems e Under Consumables in the Analyzer status screen replacement data about the Inlet Gasket Holder is shown instead of replacement data about the printer paper Instructions to Put this document in the binder of your manual user The Tro
33. 006 14 2 analyzer accessories cceee ees 14 2 arterial blood gas samplers 14 5 capillary samplers glass 14 5 capillary samplers plastic 14 5 documentation ccceeee eee 14 3 documentation QC SFI 14 4 Metabolite QUALICHECK SOMO Manda 14 4 other accessories 14 3 power COTOS seess dsd 14 2 QUALI CHECK5 solution 14 4 Quality control accessories 14 4 Range QUALICHECK solution 14 4 safePl CO samplers 14 6 sampling devices cc cece eee ees 14 5 Sensor Cassette circa 14 2 solution PACK ocooocccccccccccnconconnoo 14 2 Other activities analyzer StatuS cccccceeeeeeeeeees 3 7 P Parameter Status riadas 2 12 patient result occcoccccccccnnnncnnos 4 14 quality Ccontrol o 5 6 5 11 Parameters derived paraMeterS occocccccccnnocoo 13 3 Input paraMeterS occocccccccnnnnnnnos 13 3 measured parameters oomm 13 2 Password CHECKING AA cas coco cmnacnoe canes 2 18 PALCIES aaronii tet etait ets 13 7 Patient ID recalling 4 15 Patient identification A O E 4 10 Patient information entering information manually 4 10 entering information with barcode pr Sanacanartuetianeceuaaaies 4 10 patient lO0KUP ocoocccccccoccccncnno 4 11 selecting a report layout 4 12 selecting parameters after measurement escerai 4 12 Patient profiles l09 ooooccccccccc
34. 1000 calibration results and 5000 activity log entries has been reached The archives are located on the analyzer s disk and can be exported to a CD RW removable disk network etc see Exporting data logs chapter 2 Disk functions setup programs in the ABL9O FLEX reference manual The archives are archived after date e 500 reports from each log and e 2000 entries from the Activity log Press Menu gt Data logs gt Archived data logs Press the button on the screen to select the log archives As the functions are similar for all archives the Calibration archive is used as an example 6 19 2008 6 19 2008 7 alan a impar 3 Export 5 3 arive Sahel ry GIVE Step Action 1 Highlight the desired archive with the up down arrows Information about analyzer type and installation number along with the date this archive was generated is on the screen Press Select archive to obtain it for viewing Press if desired Filter to enter filter criteria and apply the filter Highlight the desired report by touching it on the screen and press Result to display the result 5 Press Close to exit to the main screen 9 21 9 Data management Moving an Step archive to another media 1 or from another media 2 to the analyzer Converting an archive into ABL90 FLEX operator s manual Action Press Import archive to move it The I mport Export archives screen will be displayed Proceed as described in mpo
35. 2 PROS des 8 2 E Expired calibrationS ooocoocccccccco noo 6 3 F Filter function ACUIVILY JOO said 9 19 Calibration 10Q cccceeeeeeeeee ees 9 16 Patient results lo9 ooocoooo 9 4 A Gaaraa EAN 9 11 Front analyzer aiii io 2 2 FShunt and ctO gt a v calculation 4 13 FShunt and ctO gt a v determination 4 13 H HArAWAPE ccceeeeeeeeeeeeeeeeeeeeeeeeeeas 2 2 barcode reader cccceeeeeeeeeeees 2 8 built in Sample MIXET 0cee eee 2 7 ges 2 2 Inlet module ooccccccccccccccnnnnnnncnnno 2 6 KETE N EEPE dita diode hal ated eal tebe 2 4 A aeuee en taentaenhanntantee 2 3 I Rita lO lela arranca 2 18 Inlet a tease ete 7 16 Inlet connector gasket replaceMent ccceeeeeeeeeeeeeees 7 13 Inlet gasket replaceMent ccceeeeeeeeeeeeeees 7 10 AE MOdUlE ii 2 6 Inlet probe replaceMent ccccceeeeeeeeeeeeees 7 12 Input paraMeters siii cities 13 3 Metalla tION resserre ae 7 1 Intended USO oooocccccccccccccncnn nn 1 3 Interaction tools check DUTLON Susini 2 14 screen keyboard ooocccccccccconnnnnnos 2 16 screen keypad ccccccccocncccccannnnnos 2 14 COX DOK ccadecdcanadudenetedusesedeteiade 2 13 Interfering SUDSTanCesS occcoccccccccnnoo 1 5 Introducing a blood sample with a Capillary tube occccccccccccccccnnnnnoo 4 8 Introducing a blood sample with a safePI CO sampler with barcode 4 5 Introducing a blood sample with a safePI CO sampler with barcode
36. 5 2 General IATORMAtO Ns ror co teiede soto rlisa loci n 5 3 BUIN Uat CONTO eerte a al 5 5 SYSTEM ENCON a 5 7 Contents 10 11 12 13 ABL90 FLEX operator s manual AN AIN SIS CHOCK treat ida tema tetas 5 8 Manali QUAY CONTO inana re a a aa es 5 9 Manualguality CONT Ol escasa llo lodiias 5 9 Additionaklguality Control eiaei nnee E AEA A EEEN 5 13 Calibration nic oia 6 1 General MONNA Oire iiaee aa didas cba erotica 6 2 ls y ope 11101g 141019 EPA ANO PA oleate tol ecweldieteueitatuek E scene sts 6 4 Calbration resul Ent dd ia 6 5 Callbratlon Vertical sti iii aia 6 8 REDIACEIMOGNCS iii ii 7 1 Screens during replacements occcocccccccccccccnnnnccnn nn nn 7 2 Replacements crasas 7 3 Cleaning the anal Zea iii aii 7 16 DISK TUN CIO Siri 8 1 GenerakiNOrmat Oai a dies 8 2 Data Manage mention 9 1 General INFOMATION gare Ean n a S EEE 9 2 Patente CS Utes TOO aaa EE AA 9 3 Patient DFOMMCSHO0 rerrusre idas dido ea 9 6 Qualy Control na dan 9 9 CAlIDPATION lOO caus aia a aid 9 15 A NN 9 18 Replacement co lorca blau 9 20 Archived data lOGS orar tn 9 21 RADIANCE browser Optional ooccccccccccccnncccnnnnnccn cnn cnc 9 23 Analyzer Sh tdOW Noi did 10 1 General INFOMATION 2 firccxied Aaa 10 2 Temporary SHULOOWN satan tana ioricnt 10 3 Long term ShUTOO WO caca bea 10 6 TROUDIGSNOOUNING incida 11 1 General Into MatO ss a to 11 2 General IRONMAN rad A 11 2 User intervention required CAUSES 00ccccccccccccccccnnnnnnnnnnnnnnnnn
37. 7 temperature corrections 5 12 trend function ia da 9 11 UNKNOWN SOLULIONS oocccccccccccnnoo 5 12 unscheduled measurement 5 5 Quality control QC status 3 5 Quality control identification entering information manually 5 11 entering information with barcode reader cccceeeee ees 5 10 Fecal de 5 12 Quality control log oocccccccccco o 9 9 MSF UNCON aria 9 11 printing QC statisticCS 9 14 OG DIOE aarrijsiiatcaalaiaias 9 10 viewing QC statistiCS oo o 9 12 Quality control plot 9 10 Quality MmanageMent occcccccccccccccnnoo 5 1 R RADIANCE system A A eaaweiavaseeacs 9 23 DIFOWSEN annie attend ces 9 23 Rear MAY Zin vows noes erste 2 4 Recalling quality control identification ui os 5 12 Recommended capillary blood SAM aaron 12 2 Replacement cccceeeeeeeeeeees 7 1 7 3 inlet connector gasket 7 13 INIGE GaSK Cl siaduysdssadvansendewevel ethics 7 10 inlet PrODe cccceee eee eeeeeeee ees 7 12 printer PAPEL cece cece e essen eens 7 9 screens during replacements 7 2 Sensor CASSEE ereire cnawriedednaaes 7 5 SOIUTION PACK iaeoe eec ees nee 7 4 7 8 VIEWING STatUS ooccccccccccccnnnnnnnnnnoo 7 3 Replacement 10Q ccceeeeeeneee ees 9 20 Replacement statuS 08 3 6 7 3 Requirements SVN ZCI teats eat cen aa a ae 13 5 Opera Ena cas views Toate
38. 70 PICO70 23G x 5 8 w o needle cube 0 3 1 5 mL 956 546 PICO70 100 units PICO70 25G x 5 8 0 3 1 5 mL 100 units 956 547 PICO70 PICO70 22G x 1 w o needle cube 0 3 1 5 mL 956 563 PICO70 100 units safePICO70 22G x 174 with needle shield device 956 608 PICO70 0 3 1 5 mL 100 units safePICO70 23G x 5 8 with needle shield device 956 609 PICO70 0 3 1 5 mL 100 units safePICO70 23G x 1 with needle shield device 956 624 PICO70 0 3 1 5 mL 100 units samplers glass l l l CLINI TUBES with balanced heparin 100 uL including 942 878 D957G EA 97 E CLINI TUBES with balanced heparin 100 uL including 905 663 D956G mixing wire and capillary caps 1 x75 units 70 100x1 samplers plastic safeCLINITUBES with balanced heparin 70 uL 942 898 D957P including mixing wire and capillary caps 1 x 250 70 70x1 units 14 5 14 Ordering information ABL90 FLEX operator s manual safePICO A Code No Type samplers SafePICO Self fill without needle with safeTI PCAP 956 610 0 7 1 5 mL 100 units safePICO Self fill with safeTIPCAP without needle 956 612 shield device 23G x 5 8 0 7 1 5 mL 100 units safePICO Self fill with safeTIPCAP without needle 956 613 shield device 22G x 1 0 7 1 5 mL 100 units safePICO Self fill with needle shield device and 956 614 safeTI PCAP 22G x 1 1 4 0 7 1 5 mL 100 units safeP CO Self fill with needle shield device and 956 615 safeTI PCAP 23G x 5 8 0 7
39. ABL90 FLEX operator s manual ABL9O FLEX operator s manual What is new in this manual e The calibration verification procedure has been updated e The section about how to clean the sensor cassette seat has been removed Introduction RADIOMETER Q Operator s manual Note to the operators of the ABL90 FLEX analyzer This note outlines the improvements in software version 2 8 Instructions to Put the Note to the operators in the binder of your manual and replace the operators Brief overview of the Improvements C vo i 2012 Radiometer Medical ApS All Rights Reserved 995 417 201207A Storage temperature for the sensor cassette Vocal reminder to close the inlet Video instructions of the measuring workflow More maintenance instructions included in the guided troubleshooting of the analyzer How values that lie outside the reportable ranges are shown Akandevej 21 2700 Br nsh j Denmark corresponding old front and date of issue pages with the new pages in this update kit I mprovements Description In the manual the storage temperature of the sensor cassette is incorrectly stated to be 2 10 C The correct storage temperature of the sensor cassette is 2 8 C If the inlet is not closed a voice message reminds you to do SO Video instructions have replaced most of the animations that were previously shown on the screen Videos and text instructions have been added to the
40. BL90 FLEX reference manual NOTICE Changing a control solution assigned to a slot will delete all current quality control statistics obtained on that slot If you want a copy of the statistics for the last QC month create a WDC Report see chapter 2 Disk Functions setup programs in the ABL9O FLEX reference manual To schedule a QC measurement see Quality control schedule setup in section Quality control setup in chapter 1 Setup in the ABL90 FLEX reference manual QC system Materials required QUALI CHECK5 e Four levels of QC solutions S7730 S7740 S7750 S7760 e QUALI CHECK adapter e Rubber gloves e Ampoule opener Step Action 1 QC ampoules must be conditioned before measurement Store the ampoules for 5 hours at a constant temperature between 18 32 C Control solutions are sensitive to light so always keep the ampoule box closed 2 Hold the ampoule between two fingers as shown and shake it vigorously for at least 15 seconds 3 Tap the top of the ampoule until all of the solution collects at the bottom 4 Place the ampoule in the ampoule opener and break off the ampoule neck 5 9 5 Quality management Introducing a QC solution Entering information with barcode reader Step oe Step ABL90 FLEX operator s manual Place the ampoule fully into the QUALICHECK adapter Open ampoule stability To ensure the reliability of the measurement each QC ampoule must be used immediately after
41. CH USE e NO WARRANTIES FOR THE SOFTWARE THE SOFTWARE is provided AS IS and with all faults THE ENTIRE RISK AS TO SATISFACTORY QUALITY PERFORMANCE ACCURACY AND EFFORT INCLUDING LACK OF NEGLIGENCE IS WITH YOU ALSO THERE IS NO WARRANTY AGAINST INTERFERENCE WITH YOUR ENJ OYMENT OF THE SOFTWARE OR AGAINST INFRINGEMENT IF YOU HAVE RECEIVED ANY WARRANTIES REGARDING THE DEVICE OR THE SOFTWARE THOSE WARRANTIES DO NOT ORGINATE FROM AND ARE NOT BINDING ON MS e Note on Java Support The SOFTWARE may contain support for programs written in J ava Java technology is not fault tolerant and is not designed manufactured or intended for use or resale as online control equipment in hazardous environments requiring fail safe performance such as in the operation of nuclear facilities aircraft navigation or communication systems air traffic control direct life support machines or weapons systems in which the failure of Java could lead directly to death personal injury or severe physical or environmental damage Sun Microsystems Inc has contractually obligated MS to make this disclaimer e No Liability for Certain Damages EXCEPT AS PROHIBITED BY LAW MS SHALL HAVE NO LIABILITY FOR ANY INDIRECT SPECIAL CONSEQUENTIAL OR INCIDENTAL DAMAGES ARISING FROM OR IN CONNECTION WITH THE USE OR PERFORMANCE OF THE SOFTWARE THIS LIMITATION SHALL APPLY EVEN IF ANY REMEDY FAILS OF ITS ESSENTIAL PURPOSE IN NO EVENT SHALL MS BE LIABLE FOR ANY AMOUNT IN EXCESS
42. Data management Action Press Add message on the Activity log screen If Notes were entered in the setup program User defined notes see User defined notes in section Parameters and input setup chapter 1 Setup in the ABL9O FLEX reference manual e Edit a highlighted message by pressing Edit msg to display the keyboard and make the changes e To delete a message highlight it and press Delete msg If Notes were not entered in User defined notes e Press the keyboard icon to display the keyboard e Type a message and press Enter to confirm and return to the Activity log screen Press Back to return to the Activity log screen Filter function With this function you can set the filter criteria to find an activity or to select a number of activities Operator Error code Replacement Wet section activity Wet section message Communication error User message 9 16 2009 9 17 2009 Action Set the Start date Use the 1 day 7 day 14 day or 30 day icons in the Criteria box or type in the date using the keypad and confirming the entry with Enter Change if necessary the End date by highlighting it and typing in a date other than the current date Confirm with Enter Activate the check buttons to select filer criteria use the up down arrows in the box to display more criteria Press Apply to start the filter The Activity log screen displays the list of selected activities Select the message lev
43. EX operator s manual 4 Sample measurement Introducing a blood sample with a safePl CO sampler with barcode Step Action 1 Check that the analyzer is in the Ready mode and scan the sampler barcode see Barcode reader in section Hardware chapter 2 What is what Do not remove the safeTIPCAP the analyzer probe will pierce the safeTIPCAP 2 Lift the inlet to the syringe position and follow the on screen instructions 3 Place the safeTIPCAP tip firmly against the inlet gasket and press it upwards while still holding on to the sampler cylinder The inlet probe extends into the syringe and the blood is automatically aspirated NOTICE Be careful not to bend the probe Hold on to the syringe barrel and do not press the plunger NOTICE Make sure that the plunger is not pushed back by the probe NOTICE When aspirating small blood volumes less than PICO50 samplers 1 1 mL PICO70 safePICO70 samplers 0 7 mL make sure that the heparin coated fiber disk does not block the probe during aspiration A WARNING Risk of infection To avoid the risk of infection take care not to scratch or stab yourself on the probe A WARNING Risk of erroneous results Press the inlet gasket totally up to make sure that the sample is aspirated correctly i e from the whole sample and not just the tip of the syringe Otherwise this may lead to erroneous tHb results 4 When prompted by the analyzer remove the sampler and close the
44. L PICO70 safePICO70 samplers 0 7 mL make sure that the heparin coated fiber disk does not block the probe during aspiration WARNING Risk of infection A To avoid the risk of infection take care not to scratch or stab yourself on the probe A WARNING Risk of erroneous results Press the inlet gasket totally up to make sure that the sample is aspirated correctly i e from the whole sample and not just the tip of the syringe Otherwise this may lead to erroneous tHb results When prompted by the analyzer remove the sampler and close the inlet Enter the information needed on the Patient identification screen 4 7 4 Sample measurement ABL90 FLEX operator s manual Introducing a blood sample with a capillary tube 4 8 Step 1 2 6 Action Check that the analyzer is in the Ready mode Mix the capillary sample by gently moving the mixing wire repeatedly along the length of the capillary with a magnet Then move the mixing wire to the end of the capillary opposite to that from which the blood is to be aspirated Lift the inlet to the capillary position and follow the on screen instructions Remove the capillary caps if any and press the capillary against the inlet gasket as shown NOTICE To ensure the right positioning of the capillary tube place it in the center of the inlet gasket conus A Slight turn of the capillary tube when ae positioning it might assist m with the centering The b
45. MA EMIS Manlio ces tie 1 8 What 1S What a a 2 1 a RENEE ET E E a di 2 2 COnsumables Bae ccci doen aee naa a arada tds 2 9 SOI ls 2 11 NIE OOO MM as 2 18 Menu SERUICLUI A atareconaiaciematahaduagr EE 2 19 Analyzer SCACUS id 3 1 AnalyZer Status at a Glance sc id 3 2 Analyzer status elements n ssssrserrsrrrnrrrsrrrerrnrrrrerrrerrrsrerrrrerrrerrrrrere 3 3 CaNDraCON Status nat a 3 4 Qualy COMMON C norne a OEA E a E T 3 5 REDaCEMEN US arenarie a ae e AA 3 6 Other activities lo elos 3 7 System Message 3 7 Sample Measurement nica a 4 1 General JMIORM ALON ii a Sieces a Monae hee cesta eet ctw thoes 4 2 General INTOrmM ati Miri AAA AAE 4 2 Immediately before analySiS ccccccccccccncccnnnnncnnnnnnnn narran 4 3 Introducing a blood sample with a standard Syringe cccceeeeeeeeeeeeees 4 4 Introducing a blood sample with a safePl CO sampler with barcode 4 5 Introducing a blood sample with a safePl CO sampler with barcode and sample PFE FCOISU QUO arre obd 4 6 Introducing a blood sample with a capillary tube oocococcccnncccccnnnnnnnos 4 8 Introducing a blood sample with a test tube ssssssrssrrrsrrerrrerrrsrrreree 4 9 Entering patient identification ccccccccccccccnnnnccnnnncnnnnnncna nr rr rr 4 10 Patent Tesla e aioe tee oe Goad 4 14 Patient result message Siria iS 4 19 Q ality Management iii 5 1 Automatic quality management system s ssssssrrssrrsrrrsrrrerrrrrrerrrerrrerene
46. OF U S TWO HUNDRED AND FIFTY DOLLARS USD 250 00 e Limitations on Reverse Engineering Decompilation and Disassembly You may not reverse engineering decompile or disassemble the SOFTWARE except and only to the extent that such activity is expressly permitted by applicable law notwithstanding this limitation e SOFTWARE TRANSFER ALLOWED BUT WITH RESTRICTIONS You may permanently transfer rights under this EULA only as a part of a permanent sale or transfer of the DEVICE and only if the recipient agrees to this EULA If the SOFTWARE is an upgrade any transfer must also include all prior versions of the SOFTWARE e EXPORT RESTRICTIONS You acknowledge that SOFTWARE is of U S origin You agree to comply with all applicable international and national laws that apply to the SOFTWARE including the U S Export Administration Regulations as well as end user end use and country destination restrictions issued by U S and other governments For additional information on exporting the SOFTWARE see http www microsoft com exporting ABL90 FLEX operator s manual 1 2 3 4 9 Contents Contents INTFOQAUCHON oaii a a a aiaa 1 1 ABL90 FLEX analyzer documentation ssssssrserrssrrsrrrsrrrererrrrerrrerrrrrene 1 2 Names and intended Use ENA 1 3 Limitations of use and known interfering SUDSTanCeS ooccccccncnnnnnncnnnnnnnos 1 5 Symbols used on the analyzer and accessories ccceccceeeeeeeeeeeeeeeeeeeees 1 6 SYMBOLS USCA
47. Patient report log you can filter patient reports according to the approval status e The button changes to Send after the approval of the patient result has been made if selected in Communications setup see chapter 1 Setup in the ABL9O FLEX reference manual ABL90 FLEX operator s manual 4 Sample measurement Acid Base chart 20 30 PaE O mmal pca in arterial 68 69 7 0 71 72 73 74 75 7 6 7 7 78 Press Acid Base chart on the Patient result screen to view the acid base chart for the selected patient result the button will not be available if pH and pCO have been deselected in the Parameter setup The sample type should be either Arterial or Capillary The chart illustrates the patient result according to the Siggaard Andersen nomogram The clinical conditions correspond to each of the eight zones listed to the right of the screen The point position is determined by the pH and pCO values from the patient result If the pH and pCO values are outside the defined limits of the acid base chart the message Measurement out of range will appear on the chart in red and the Print button will disappear print out the displayed acid base chart and the corresponding patient result if available see above To print the acid base chart automatically activate the check button in the Patient reports setup see chapter 1 Setup in the ABL9O FLEX reference manual to return to the patient result screen NOTICE
48. ader Built in sample mixer Compartment with sensor cassette Inlet Solution pack N OO UW Bb 0 N e Battery pack The battery pack enables for a limited period of time the performance of measurements and the storage of data without the analyzer being connected to mains or during power failure 2 2 ABL90 FLEX operator s manual 2 What is what Top 1 Handle 2 USB port 3 Thermal printer 2 3 2 What is what Rear 2 4 O O N oO Ww A W N e m O e N p ABL90 FLEX operator s manual e ae Die OP Standby button Mouse port Keyboard port External VGA monitor port for test purposes only COM port Ethernet port USB ports Ventilation Latch for manual release of the solution pack Mains power switch on some versions the mains power switch may show ON and OFF instead of I and O Fuses Mains socket ABL90 FLEX operator s manual 2 What is what NOTICE The analyzer should always be placed so that power can be easily switched off in emergency situations and so that the ventilation is not covered Detachable power supply cord For US 125 VAC For Europe 265 VAC NOTI CES UL listed and KAM cord min type SV 18 AWG 3 conductors Rated min 60 C Provided with a molded grounding type NEMA 5 15P attachment plug rated 125 VAC min 2 5 A Opposite end terminates in molded IEC 320 style connector rated 125 VAC min 2 5 A Cord type min HO5RR
49. ailable on your analyzer it depends on your sensor cassette version e FHbF is by default disabled ABL90 FLEX operator s manual 4 Sample measurement Immediately before analysis The blood sample must be mixed immediately before it is introduced into the analyzer to ensure its homogeneity If a sample is transferred from a sampler to the analyzer without having been properly mixed either the plasma phase or the packed red blood cells may be analyzed making the oximetry results meaningless safePl CO sampler Place the syringe in the built in Sample mixer on the front of the analyzer The mixer Starts automatically and stops when the sample has LO been sufficiently mixed A Alternatively invert the syringe repeatedly roll it between the palms of your hands and follow your standard operating procedure Capillary tube Mix a capillary sample by gently moving the mixing wire repeatedly along the length of the capillary with a magnet Then move the mixing wire to the end of the capillary opposite to that from which the blood is to be aspirated Remove both capillary caps Test tube Invert the test tube repeatedly Then remove the cap CAUTION Relevant capillary tube volume Too small capillary volume will give the Insufficient sample error See chapter 12 Sampling for guidelines on how to handle blood samples Before introducing the sample into the analyzer check the availability and status of the desire
50. amaged e It is only recommended to remove the sensor cassette from the sensor cassette compartment if you want to replace the old sensor cassette with a new one If however it becomes necessary to remove it for a short period of time e g during a troubleshooting procedure etc the sensor cassette must be placed back into the sensor cassette compartment within 2 hours During removal it must be placed in an upright position and not on the side 1 7 7 Replacements ABL90 FLEX operator s manual Startup after sensor cassette replacement 7 8 The calibration status is checked 1 2 and 3 hours after sensor startup e g after replacements or when the power is turned on If a parameter except for the oximetry parameters is marked with a a re calibration of the relevant parameter is performed if the analyzer is in the ready mode The internal QC status is checked 1 2 and 3 hours after sensor startup and once every 4 hours after any calibration performed The calibrations are scheduled every 4 hours and the 4 hours checks continue up to 24 hours after sensor startup If a built in QC level is marked with a for a given parameter except for the oximetry parameters and the calibration status is OK the relevant QC levels are re scheduled and performed according to the schedule These checks accelerate the time for all parameters being ready after a sensor cassette replacement The parameters are ready when there is
51. aminated with blood or other liquids Cleaning the Step Action inlet 1 Press Menu gt Analyzer status gt Other activities gt Inlet check Zi Clean the inlet gasket see step 3 below the inlet area and the handle as required 3 Remove the inlet gasket with holder and the probe from the inlet see above Soak the inlet gasket with holder and the inlet probe in a Deconex cleaning solution or a similar detergent Deconex cleaning solution is used in soaking baths and ultrasonic cleaning systems for cleaning laboratory utensils and precision components to remove moderate to most resilient contamination of an organic nature NOTICE Do not inject Deconex cleaning solution into the analyzer as this will damage the sensors 4 Rinse thoroughly with demineralized water to remove all Deconex cleaning solution or similar detergent 5 Remount the inlet gasket with holder and the inlet probe Check that the inlet probe is in the correct position Remount the inlet see above and close it Press Done Cleaning the When cleaning the analyzer covers and outer case use soapy water or a mild analyzer detergent exterior Do not use abrasive cleansers or pads ethanol based substances or aggressive detergents for cleaning ABL90 FLEX operator s manual 7 Replacements Cleaning the Step Action analyzer screen 1 Put your thumb at an inactive place on the screen e g on the Ready text in the upper left corner of the main screen and keep th
52. ample collection into a capillary 12 7 12 Sampling ABL90 FLEX operator s manual Cause of Possible Suggestions to preventive measures error problem Sample stored Bias on all e See Storage time and temperature for too long parameters recommendations in this chapter before being and Bulletin No 31 14 analyzed Insufficiently Bias on ctHb Mix the sample in two dimensions by mixed sample rolling it between your hands and inverting it vertically prior to transfer into the analyzer If the sample is visibly sedimented it needs mixing for several minutes Blood gas analyzers with automatic mixing prior to measurement built in Sample mixer arterial blood gas Samplers with a ball for mixing and capillaries with a mixing wire WARNING Risk of infection Dispose of the used samples and blood remains as infectious waste to avoid exposing others to the risk of infection 13 12 8 ABL90 FLEX operator s manual 12 Sampling References List of This section lists the references applicable to blood sampling and blood gas references analysis associated with this chapter 1 CLSI Procedures for the collection of arterial blood specimens approved standard Fourth Edition CLSI NCCLS document H11 A4 Clinical Laboratory Standards Institute 940 West Valley Road Suite 1400 Wayne Pennsylvania 19087 1898 USA 2004 Mahoney JJ Van Kessel A Arterial blood gas analysis Respir Care 1997 249 79 Smeenk F Janssen J A
53. and wait for the solution pack to unlock Remove the used solution pack and dispose of it as infectious waste according to the regulations in your Institution Activate the new solution pack by pulling out the safety pin a i Press the lid firmly down by pressing the elevated side where the safety pin was down until the side taps click into the side tap holes Side taps holes Side taps Remove the top layer of the label on top of the solution pack so that the biohazard label appears to remind you that the solution pack after use must be disposed of as infectious waste Insert the new solution pack by pushing it fully into place in the analyzer until a click is heard When prompted by the analyzer close the inlet Enter operator name and any notes using the Keyboard or the Note button to display the keyboard and to enter the operator name note Confirm the entry with the Enter button on the keyboard ABL90 FLEX operator s manual 7 Replacements Manual release of the solution pack 10 Press OK to restart the analyzer NOTICE By default a QC will be performed after a solution pack replacement However if this function has been deactivated it is recommended to perform a built in QC after solution pack replacements to assure that the consumables have not been damaged In emergency situations e g during a power failure or if for some reason the analyzer is down it is possible to release the solu
54. at the rear of the analyzer may also have been used If the temporary shutdown feature is not used for the short time shutdown the analyzer must be in the Ready mode to perform a warm start Otherwise a cold start will be performed e The analyzer must have been in the Ready mode when it was temporary shut down ABL90 FLEX operator s manual 10 Analyzer shutdown e The sensor startup sequence with calibrations must have been completed e The sensor used is the same as before the restart e The sensor cassette has been maintained properly by the analyzer no more that 2 hours since last rinse or flush e No QC measurement or calibration has meanwhile become overdue If these preconditions are not fulfilled the startup time will be longer and perhaps result in a cold start For further information about cold starts see section Calibrations related to startups in chapter 6 Calibration 10 5 10 Analyzer shutdown ABL90 FLEX operator s manual Long term shutdown Purpose 10 6 This program is used to prepare the analyzer for a long term storage if it will not be used for a period of time or if it has to be moved to another location so that it requires removal of system components and emptying the analyzer of solutions The shutdown procedure takes approximately 15 minutes Step Action NOTICE It is recommended to clean the inlet before starting the long term shutdown procedure Enter the Long term shutdown program R
55. ata will be stored as a patient profile in the analyzer s database without however being attached to any patient report The data can be reused the next time the same patient ID is used Patient lookup The Patient lookup function allows you to transfer the patient information from a department s specific list to the Patient identification screen if the following conditions are fulfilled im maine Data source Should be selected in Patient lookup setup see Patient lookup setup in section Communications setup chapter 1 Setup in the ABL9O FLEX reference manual for details for the specified data source e LIS HIS e Analyzer s local database Exclude from Number of days that you want each patient to be kept in patient list after the list should be selected see Patient lookup setup in section Communications setup chapter 1 Setup in the ABL90 FLEX reference manual for details Department Pat Must be included and filled in on the Patient identification screen 4 Sample measurement Selecting a report layout De selecting parameters after a measurement Step Step Step ABL90 FLEX operator s manual Action Highlight and fill in the Department Pat field on the Patient identification screen Press Patient lookup Select your patient from the list by highlighting the corresponding line on the screen Press Update to update the Patient list e Press Select to transfer the specific patient
56. blication C32 P Clinical Laboratory Standards Institute 940 West Valley Road Suite 1400 Wayne Pennsylvania 19087 1898 USA 1993 Christiansen TF Measurement of potassium in whole blood Radiometer Publication AS92 Copenhagen Radiometer Medical A S 1983 Code 918 231 Wandrup JH Clinical and analytical requirements and needs of glucose measurements on whole blood Radiometer Publication AS122 Copenhagen Radiometer Medical A S 1996 Code 918 549 Wandrup JH Tvede K Grinsted J Jordening H STAT measurements of L lactate in whole blood and cerebrospinal fluid assessed Clin Chem 1989 35 8 1740 43 Wu E Barazanji K Johnson R Sources of error in A aDo2 calculated from blood stored in plastic and glass syringes J Appl Phycial 1997 82 196 202 Young DS Preanalytical issues in neonatology www bloodgas org 2002 Clark CG et al Preanalytical errors in simultaneous blood gas electrolyte and metabolite analysis www bloodgas org 1998 Narayanan S Preanalytical issues related to blood gas sample mixing www bloodgas org 2005 Wennecke G Useful tips to avoid preanalytical errors in blood gas testing electrolytes www bloodgas org 2003 Wennecke G Useful tips to avoid preanalytical errors in blood gas testing metabolites www bloodgas org 2004 Blonshine SB Arterial blood collection part 1 of 2 www bloodgas org 2005 Blonshine SB Arterial blood collection sampling and storage part 2 of 2 www blood
57. can be viewed as soon as the calibration is completed Results from calibration the most recent calibration can be viewed via Menu gt Analyzer status gt result Calibration gt Result or via the Calibration log Calibration result Status 10 0 mv Sens 99 0 mmHg Status 16 0 mv mmHg Sens 91 9 mmHg Status 5 2 mmHg mmHg Sens 93 mmol L Status 201 0 mv mmol L Sens 98 0 mmol L Status 202 0 mw mmol L Sens 97 0 mmol L Status 203 0 mv mmol L Sens 96 0 Button Function Press to display the remainder of the calibration result Messages Press to display the interpretation of any detected errors Print Press to print out the result Send Press to send the result to a connected LIS HIS system 6 5 6 Calibration tHb calibration result 6 6 ABL90 FLEX operator s manual Calibration data are grouped together by parameter Bold characters Gray characters Indicate data updated during this calibration Black parameters origin from the last calibration and gray parameters may origin from multiple earlier calibrations Indicates an error or that the value is outside the recommended range such as e Drift value outside the drift tolerances shown as a message not a value e Status outside the default limits e Sensitivity outside the default limits Indicates that the value could not be calculated most likely due to a system error or malfunction These values will for the most par
58. ccccccccccccn noo 2 13 parameter DaP cccceeeeeeeeeeeees 2 12 status Drama 2 11 UNS Gee aos 2 11 COP SECO iana dde 2 11 Screen keypad ssssssrsssrrrssrrrere 2 14 Sensor cassette cece eee eeeeeeees 7 5 CONFIQUIATIONS cece eeeee cece eeeee ees 1 4 parametef s iii 1 4 FEDLACEIIENK wii scatacccmnnaninsandantons 7 5 vana 1 4 Sensor cassette pack with sensor CASO e sare 2 9 SOWO aos 2 11 screen CIQMENTS ccccec cece eeeeeeeeeeees 2 11 Soluti0N Pack cccc eee eeee ees 1 4 2 10 Manual rele Se cccceeeeeeeeeeeees 7 5 replaceMent ccceeeeeeeeees 7 4 7 8 Special considerations for capillary Species 12 3 SPECIFICATIONS ccccssecccuveceunneeennees 13 1 a a Zaira 13 6 analyzer requirements 13 5 APPO nica nana 13 7 derived parameters 00008 13 3 Input paramMeterS oocccccccccnnncncoos 13 3 measured parameters 555 13 2 DALCIUS atrial vedi ee 13 7 sample Nandling cccceeeeeeees 13 4 Startup analyze siii anida bios 2 18 Storage recommendations special considerations 12 5 whole blood samples 12 5 Substance interfering SUDStanCeS occcccccccoo 1 5 Switching off the analyzer for a A aisea 10 3 Symbols ACCOSSO MES ria 1 6 Na ZE 1 6 used in this manual cccccccccccoo 1 8 System Chetkisia asia 5 7 System messages analyzer StatUS occcccccoccncccnconnnnnos 3 7 T Tempe
59. ccnnncnoo 3 5 replaceMent cccceeeeeeaees 3 6 7 3 system Messages nio vee vee eee 3 7 Analyzer status elements 0 5 3 3 Analyzer outer surfaces a enaa 7 18 Anta DIO ads 1 4 Approval patient result ooooocccccccccccnccooo 4 16 A nce eke eiha dete tsa 13 7 Archived data l0dS ccceeeeee ees 9 21 Converting archive ccceeeeee ees 9 22 MOVING archive ccccc ee eeee eee eees 9 22 selecting archive cccee cece eee 9 21 Arterial blood samplers recommended cccceeeeeeee eens 12 2 Audit trail patient result 4 18 Automatic quality management SY SM 5 2 B Barcode readel cccceeeeeeeeeeeeeeeees 2 8 entering patient information 4 10 POSION Otras tad 2 8 Mo ola 2 8 Barcode reader built in 2 8 Barometer icteadadncunuddsesaaadeiatucn tule 13 2 Blood animal blood measurements 1 4 Blood samplers recommended arterial blood SaMMDIGNS Gorrian aaa 12 2 recommended capillary blood SAIMPICNS cala 12 2 Built in quality control 5 5 Built in sample M Xer ooocccccccccnncnnos 2 7 C Calibracion 6 1 l or 2 point result oocccccccccccc ooo 6 5 EXPDIESO irradia 6 3 general informati0N oooocccccccnnn ccoo 6 2 messages result cccceeeeeeee ees 6 7 pending calibrations 6 3 PEO FAM ta dra 6 2 FeSUI Basicos 6 5 THD re Era 6 6 unscheduled calibration 6 2 Vencido 6 8 VIEWING resul
60. co ooo 9 6 adding new profile 9 7 deleting profile oooocoocc o 9 7 edO astas rada danes 9 7 PINGING Profile seses siais 9 8 Patient result occcccocccccccconnccnnnnos 4 14 acid base chart ccceeeeeeeees 4 17 AD OIOV Aese E R E tees 4 16 UCIC Cr Aeee era e e E E 4 18 MESSAGES ien tts 4 19 parameter StatUS sinini 4 14 recalling patient ID 4 15 Patient results lO9 ooocccccccccccccc ooo 9 3 filter function ato aia 9 4 FUNCTIONS S Masini dao 9 4 trend function ccc ee eeeee eee eeeees 9 5 Pending calibrations ccceeeeeeees 6 3 Power supply cord cceeeeeeee ee eens 2 5 Preanalytical phase possible causes of errors 12 6 Preparations immediately before IVY SIS ala teat 4 3 Printer paper replaceMentt ccccceeeeeeeeeeeeeeees 7 9 Proprietary NAME cccceeeeeeeeee eens 1 3 Q QC statistics ella aye ETENE tree Mewar mnt ttt tater ner ee 9 14 VIC WING OT 9 12 Quality CONTO viciado a a 5 1 additional quality control 5 13 analysis CNECK cccccceeeeeeeeeeee ees 5 8 automatic quality management CONO 5 2 CEE PA OO et tek saan bee ae ee eee 5 5 general information 00eee 5 3 glossary lla cee te ae a is 5 3 identification cccceeeeeeeeeeeees 5 10 manual Measurement 06 08 5 9 parameter statuS 5 6 5 11 SYSTEM CNECK cccce cece eee eeeee ees 5
61. crease in the lactate concentration and a decrease in the glucose concentration For samples within the typical reference range this corresponds to an average change in the lactate concentration of 0 25 mmol L and of 0 2 mmol L for glucose over 30 minutes at room temperature 11 12 5 12 Sampling ABL90 FLEX operator s manual Causes of error in the preanalytical phase Introduction Possible causes of error 12 6 The major source of error in blood sample analysis is the preanalytical phase Some of the errors can be prevented by choosing proper devices and others should be addressed in training and procedures In general always adhere to local procedures Some of the possible causes of error during the preanalytical phase and suggestions to preventive measures are described in the table below For more information see also Recommended literature at the end of this chapter Cause of Possible error problem Missing or erroneous patient and or sample ID Respiratory condition of patient Heparin low concentration Heparin interference Heparin dilution from liquid heparin Insufficient amount of flush solution is discarded from catheter Infusion solution given in same arm Patient result mix up Bias on pH and blood gases Bias on electrolytes especially cCa Biased results likely on all parameters Biased results likely on all parameters Biased results likely on all parameters
62. d parameters For detailed information see chapter 3 Analyzer status in this manual 4 3 4 Sample measurement ABL90 FLEX operator s manual Introducing a blood sample with a standard syringe 4 4 Step 1 2 Action Check that the analyzer is in the Ready mode Lift the inlet to the syringe position and follow the on screen instructions Place the syringe tip firmly against the inlet gasket and press it upwards while still holding on to the sampler cylinder The inlet probe extends into the syringe and the blood is automatically aspirated NOTI CE Be careful not to bend the probe Hold on to the syringe barrel and do not press the plunger NOTI CE Make sure that the plunger is not pushed back by the probe NOTI CE When aspirating small blood volumes less than PICO50 samplers 1 1 mL PICO70 safePICO70 samplers 0 7 mL make sure that the heparin coated fiber disk does not block the probe during aspiration WARNING Risk of infection A To avoid the risk of infection take care not to scratch or stab yourself on the probe WARNING Risk of erroneous results Press the inlet gasket totally up to make sure that the sample is aspirated correctly i e from the whole sample and not just the tip of the syringe Otherwise this may lead to erroneous tHb results When prompted by the analyzer remove the sampler and close the inlet Enter the information needed on the Patient identification screen ABL90 FL
63. d to startups in chapter 6 Calibration 10 7 10 Analyzer shutdown ABL90 FLEX operator s manual 10 8 11 Troubleshooting General information cc cece cece cece rr User intervention required CAUSES sssssssrresrrrerrrrrrerrrerrrerrrrrrrrrrene 11 Troubleshooting ABL90 FLEX operator s manual General information Analyzer action Depending on the severity of the error the analyzer will do one of the following in case of error e continue its activity but mark relevant parameter results with a interrupt and abort its activity enter the user intervention required mode deny measurements and calibrations Operator To locate and remedy analyzer messages do the following actions in case of error Step Action 1 Check which of the status button indicators is red or yellow on the Analyzer status screen 2 Press the relevant button example Calibrations was pressed FA caivrati A Calibrations 06 11 2009 04 02 2010 3 months Quality contral pm Qe Replacements Other activities System feet ae 506 Cal expired 0608 Cal expired pCO2 0609 Cal expired pO2 0610 Cal expired K 0611 Cal expired Na 0 0612 Cal expired Ca 0 0613 Cal expired Cl 0614 Cal expired Glu y 0615 Cal expired Lac Trouble shoot Highlight the desired error the first line is automatically highlighted 11 2 ABL90 FLEX operator s manual 11 Troubleshooti
64. ds and out of the compartment with thumb and index finger Dispose of the used sensor cassette as infectious waste according to the regulations in your institution Remove the foil on top of the sensor cassette pack by pulling the foil upwards and Off Screw off the revealed lid of sensor cassette pack by screwing it off counterclockwise Remove the new sensor cassette by pulling it out of the sensor cassette pack with thumb and index finger ABL90 FLEX operator s manual 10 11 7 Replacements Holding the new sensor cassette with the thumb and index finger press the caciomerer E new sensor cassette firmly into the sensor cassette seat in the sensor compartment until resistance is met Press Proceed The sensor cassette compartment closes and a new Replacing sensor cassette screen appears Enter operator name and any notes using the Keyboard or the Note button to display the keyboard and to enter the operator name note Confirm the entry with the Enter button on the keyboard Press OK to finish or press Replace solutions to replace the solution pack too see Solution pack earlier in this chapter Wait until the restart sequence has been finished NOTICES By default a QC will be performed after a sensor cassette replacement However if this function has been deactivated it is recommended to perform a built in QC after sensor cassette replacements to assure that the consumables have not been d
65. e thumb pressed against the screen 2 Use a dry or lightly dampened soft lint free cloth to clean the screen Wipe the screen gently to remove fingerprints and or dirt To avoid streaking an approved screen cleaner is recommended 3 If you need to clean the place where you put your thumb find another inactive place on the screen and put your thumb there 7 Replacements ABL90 FLEX operator s manual Disinfection of Disinfection of the outer surfaces is performed when appropriate The frequency outer surfaces depends on local requirements and on the use of the analyzer Prior to disinfection always ensure that that analyzer surfaces are clean and without residues from blood and or liquids NOTICE Follow legal and local rules for safe work practices with chemicals Wipe the outer surfaces of the analyzer and the touch screen using a disinfectant on a paper towel or tissue Disinfectants to use 70 isopropyl alcohol 70 ethanol 4 Diversol BX General information 8 Disk functions 8 1 8 Disk functions ABL90 FLEX operator s manual General information Disk functions To access the Disk functions setup programs press Menu gt Utilities gt Disk programs functions The following programs are available by pressing a corresponding button Button WDC report Backup all data Restore all data Export data logs I mport Export archives Save setup Load setup Restore Function To make
66. e The buttons are designated in bold italics in this manual e g Menu Utilities etc e The buttons displayed in full color can be activated A grayed out button is currently inactive e The buttons can be selected in the Access Profiles setup program together with the access profiles for each operator for detailed information see the description in Access profiles in section Analyzer security in chapter 1 Setup in the ABL9O FLEX reference manual Note the functions of the following buttons Returns you to the previous screen in the same program e g in the Patient Results log it will return you from the Patient identification screen to the Patient result screen Returns you to the Main screen 2 What is what ABL90 FLEX operator s manual Information bar The information bar is placed in the lower right corner of the screen 3 2 1 A Logoff Radiometer 11 31 PM 1 Clock shows the current time in the selected format Date shows the current date 3 RADI ANCE System icon shown in the information bar if connection has been established ABL90 FLEX operator s manual 2 What is what Access rights Entering standard password Initial logon The following actions are allowed at analyzer startup e Performing a measurement e Calling a calibration e Viewing Editing data in the data logs e Performing a replacement Geta lage Syrapielar Egan gaat Radiometer METRO Step Actio
67. e checks e Mechanical checks e Electronical checks e Measurement preparation checks e Consumable checks The analysis checks are performed every second hour according to the default scheduled analysis activities calibrations and QC measurements and in connection with patient sample measurements For further information on the individual checks please refer to section Quality management in chapter 5 Sensors and measuring technologies in the ABL9O FLEX reference manual ABL90 FLEX operator s manual 5 Quality management Manual quality control Required materials Before measurement on a control solution As an alternative to built in quality controls you may analyze manual QC samples if desired Quality control measurements should be performed in accordance to local state and federal regulations It is recommended to use QC material from Radiometer the QUALICHECK5 control system to ensure an optimal performance of the analyzer and to take advantage of features such as temperature correction and automatic QC level detection See Appendix Quality control in the ABL9O FLEX reference manual It is possible to use non Radiometer solutions although the accuracy and validity of the results cannot be guaranteed To assign a quality control solution to a specific slot or to change the quality control solution of a slot see Manual quality control QC solutions in section Quality control setup in chapter 1 Setup in the A
68. e trademarks of Microsoft Corporation Sybase SQL Anywhere is a trademark of Sybase Incorporated Warranties and disclaimer Radiometer makes no warranties express or implied other than expressly stated Any warranties expressly stated in this document are conditional upon the system being installed used and maintained in accordance with Radiometer procedures including that only accessories meeting the specifications provided by Radiometer are used Radiometer disclaims any liability for system performance if the system is not installed used and maintained in accordance with Radiometer procedures or if accessories not meeting the specifications provided by Radiometer are used Further Radiometer disclaims any liability for loss of data and direct consequential or other dama ges including loss of profit or loss of business whether such claim for damages is based upon contract negligence or tort including strict liability and even if Radiometer has knowledge of the possibility of the potential damage or loss Confidentiality The contents of this document shall not be reproduced or communicated to any third party without the prior written consent of Radiometer Changes This document is subject to change without notice While every effort is made to ensure the correctness of the information provided in this document as changed from time to time Radiometer disclaims any liability for errors and omissions Radiometer the Rad
69. ead the instructions on the screen and press OK to start the long term shutdown procedure 3 Prepare sensor cassette removal Before removal of the sensor cassette decontamination with hypochlorite solution and a cleaning with distilled water must be performed A syringe with hypochlorite solution 55362 and a syringe with distilled water should be readily available Lift the inlet to syringe position Place the tip of the syringe with 55362 hypochlorite solution firmly against the inlet and press it upwards while still holding on to the sampler cylinder The inlet probe extends into the syringe and the hypochlorite solution is automatically aspirated NOTI CE Be careful not to bend the probe Hold on to the syringe barrel and do not press the plunger 4 When prompted by the analyzer remove the syringe and close the inlet Wait for the decontamination to end ABL90 FLEX operator s manual 10 Analyzer shutdown 5 Lift the inlet to syringe position Place the tip of the syringe with distilled water firmly against the inlet and press it upwards while still holding on to the sampler cylinder The inlet probe extends into the syringe and the distilled water is automatically aspirated NOTICE Be careful not to bend the probe Hold on to the syringe barrel and do not press the plunger 6 When prompted by the analyzer remove the syringe and close the inlet Wait for the cleaning to end 7 Sensor cassette removal The sen
70. el by pressing User Manager or Service e Press Filter to set other search criteria if desired e Press Back to return to the main screen 9 Data management ABL90 FLEX operator s manual Replacement log Replacement The Replacement log shows the replacement records of the activity log log The records are listed chronologically and can be displayed at user manager or service level The following functions are available by activating a button Print Tap this button to print a list of all the replacement records Troubleshoot Tap this button to display the error description operator actions and in some cases also a removal condition see chapter 11 Troubleshooting in this manual and also chapter 10 Analyzer messages in the ABL9O FLEX reference manual for detailed information Only visible if Sensor cassette removed is selected For the record Sensor cassette removed you can for diagnostic use generate a printout with sensor cassette data system messages and data about the latest calibration and built in QC before replacement Close This button returns you to the main screen 9 20 ABL90 FLEX operator s manual 9 Data management Archived data logs Purpose Selecting an archive saved on the analyzer You can view the old patient reports QC results calibration results and activities that have been archived automatically when the maximum log size of 2000 patient reports 2000 QC results
71. elected for the measured parameters and a special feature described below IS provided to assist in the collection of this data Once the reportable ranges are established follow your local state and federal guidelines the limits may be entered in the Reportable ranges program described in Analysis setup chapter 1 Setup in the ABL9O FLEX reference manual NOTICE Once the first measurement in this mode has been done the mode is available for the next 7 days In the 14 day period that follows the Calibration Verification mode is not available as measuring mode This is how the Calibration Verification mode is set up Step Action 1 Tap Menu gt Utilities gt Setup gt Analysis setup gt Syringe modes Tap a button with no text in the Select button to set up field Select the Button is enabled check button Tap the arrows in the Measuring program field until Cal Verification is shown on the button NOTI CE Cal Verification will only be shown on the button not in the Measuring program field 5 Tap the Close button This procedure is only to be done when you set up the analyzer The Cal Verification mode is a preset measuring mode that lets you analyze solutions for calibration verifications as patient samples Radiometer recommends that Radiometer QUALICHECK solutions are used for the calibration verification Step Action 1 Condition the Radiometer QC solution see section Manual quality c
72. enous OK 3578 Goodman Arterial OK 3577 Ray Prof Test OK 3576 Roy Capillary OK 3575 Geller Venous OK 3574 Smith Arterial OK 3573 Reid Praf Test OK 257 Gandman Icon that describes the screen it is the same as the button that gives access to that screen Screen header or name Navigation buttons see below ABL90 FLEX operator s manual Navigation tools q z 3 of on y OK E on 5 Prof Test a 4 on 3 ae 2 on i oe z a Interaction tools text boxes 2 What is what The first line is highlighted on the screen To highlight another line touch it on the screen or use Up down single arrow scroll buttons that highlight one item at a time upward or downward Page up down double arrow scroll buttons that highlight an item at the top or the bottom of each screen Left right single arrow scroll buttons that move a text box horizontally when the box extends beyond the area available on the screen The first line is highlighted To highlight another line use the up down arrows or touch the line in the box Enter the data using the screen keypad or screen keyboard In this text box you can select one of the predefined options Use the up down arrows to select an item If the text box already contains an entry it will be overwritten and cannot be retrieved In this manual text boxes are written in inverted commas e g Operator The Same applies to the other e
73. eter status Unscheduled built in QC measurement Reference 5 6 ABL90 FLEX operator s manual The absence of any markings next to a parameter indicates that a parameter was measured without fault Marking W ty 44 y Explanation Error in the previous calibration or analyzer malfunction A violated Westgard rule A violated RiLiBAK rule Parameter value is outside the control range but inside the Statistics range Only the values within the statistics range are considered accepted and are included in the QC statistics Parameter value is outside the statistics range and is not included in the statistics Parameter value is outside the range of indication Measurement is not included in the statistics Parameter values with user defined corrections see Parameter setup in section Parameters and input setup in chapter 1 Setup in the ABL9O FLEX reference manual for details Parameter value could not be calculated most likely due to a system error or malfunction These values will for the most part be accompanied by a To obtain a possible explanation press Message To evaluate the analyzer quality control status at a glance enter the Analyzer status screen Fur further information about the analyzer quality control status see section Quality control QC in chapter 3 Analyzer status To start an unscheduled built in QC measurement do the following Step 1 Zi 3 Action Press Menu
74. explanation of the terms are described in chapter 3 Wet section and chapter 5 Sensors and measuring technologies in the ABL9O FLEX reference manual Step Action 1 Check that the analyzer is in the Ready mode 2 Press Menu gt Start programs gt Calibration programs and call a calibration The following options are available e calibration e tHb calibration If a button is grayed out a calibration cannot be called Due to significant drift the cGlu cLac Oxi and pCO calibrations have a reduced validity time for the first 24 hours after cold starts and sensor cassette replacements The first 24 hours the validity time of the cGlu cLac Oxi and pCO calibrations gradually increases to 4 hours the span between scheduled calibrations During the first 4 hours no additional calibrations are scheduled but a measurement takes up to 3 minutes because a calibration is performed with every measurement After 4 hours calibrations are run in fixed intervals according to the table below and a measurement takes 35 seconds Time installed Time between calibrations 0 4 hours O minutes performed with every measurement 4 6 hours 15 minutes 6 8 hours 30 minutes 8 12 hours 60 minutes 12 24 hours 240 minutes If the analyzer is only turned off for a short period of time and certain preconditions are fulfilled a warm start may be performed instead of a cold start For further information about the warm start and the precondit
75. fety pin and press the lid down see Solution pack in section Replacements in chapter 7 Replacements in this manual for further information ABL90 FLEX operator s manual 2 What is what Software Screen elements Main screen ES Meat ats tons L 1 sO OHb COHb MetHb HbF HHb K Na Ca Cr ABLSO 2 EEE a LE Logoff 77 1 mero Radiometer RADIANCE PM 1 Top section see below 2 Center section see later in this chapter 3 Bottom section see later in this chapter The main screen appears automatically if the touch screen is idle for more than 3 minutes Top section Analyzer E e 24 premade Data logs sO O Hb COHb MetHb HbF HHb 1 Status bar describing the current task of the analyzer e g calibration measurement or its status e g ready for use locked 2 Time bar seen only when the analyzer is performing an activity The time bar follows the progress of the task If you are performing a sample or QC measurement a calibration or a cold or warm start a text appears underneath the time bar telling you when the analyzer approximately will be ready again e g Ready within 1 hour 2 11 2 What is what Center section Parameter status Green Yellow Red ABL90 FLEX operator s manual Parameter bar listing all measurement parameters available and activated on your analyzer You may judge the parameter status at a glance before you perform a measurement
76. fined by the user in the Quality control schedule setup program see section Quality control setup in chapter 1 Setup in the ABL9O FLEX reference manual Built in QC results are assigned to the slots A B and C The assigned value and acceptance range for each parameter are entered automatically into the analyzer each time a new solution pack is installed A scheduled QC measurement will start on time provided that no calibrations are pending A pending calibration will be performed before the scheduled QC measurement Press Result e on the Quality control identification screen e from Menu gt Analyzer status gt Quality control e from the Quality control log Blood gas values pH 7 085 7 082 7 122 pco 68 6 mmHg 606 706 po 153 mmHg 135 155 Electrolyte values 1 9 mmol L 155 mmol L 1 00 mmol L 120 mmol L Oximetry values 7 8 g dL f Metabolite values 50 1 0 51 cGlu 44 3 5 45 cLac 6 6 FMetHb 5 0 2 3 mmol L 4 8 mmol L f SENG i calliratian Brine Messages The measured values are compared with the defined control range statistics range and range of indication and then given a status mark accordingly NOTI CE The user defined corrections slope and offset do not influence the quality control results unless the Apply parameter corrections to QC function has been activated in Miscellaneous setup see chapter 1 Setup in the ABL90 FLEX reference manual 5 5 5 Quality management Param
77. g Quality control log Calibration log Activity log Replacement log Archived data logs Contains Up to 2000 patient reports from which you can view patient reports print and or send patient reports search for a patient report and make a parameter trend for the selected patient reports A list of patient profiles i e general information about patients from which you can find and view patient profiles add edit or remove a patient profile Up to 2000 QC results from which you can view QC results view Statistics and plots of results print and or send results search for a particular result and make a parameter trend for the selected QC results Up to 1000 calibration results from which you can find and view results make a parameter trend for the selected calibrations print and or send results Up to 5000 records of all measurements replacements system messages and operator messages From the log you can search for an activity add an operator message print and or send records Shows the replacement records of the activity log which can be printed For the record Sensor cassette removed you can for diagnostic use generate a printout with sensor cassette data system messages and data about the latest calibration and built in QC before replacement Old patient reports QC results calibration results and activities that have been archived when the above mentioned log sizes have been reached The a
78. gas org 2005 Higgins C Pneumatic tube transport of samples for blood gas analysis www bloodgas org 2005 Biswas CK Ramos JM Agroyannis B Kerr DNS Blood gas analysis effect of air bubbles in the syringe and delay estimation B Med J 1982 284 923 27 Mueller RG Lang GE Beam JM Bubbles in samples for blood gas determinations a potential source of error Am J Clin Pathol 1976 65 242 49 13 Specifications Measured parameter Smarr tddi lord paladines 13 2 Input parameters iaa AAA AS AA AAA AE AA ARS 13 3 Sample Nan cistitis a ao 13 4 Analyzer Tequirements pitan is 13 5 Analyzer specifications ita a A ci 13 6 APPrOVaIs ana patenta 13 7 13 1 13 Specifications ABL90 FLEX operator s manual Measured parameters Blood For the numerical format that depends on the individual ranges see chapter 8 Parameters in the ABL9O FLEX reference manual Parameter Range of Reportable range indication default pH scale 6 818 7 797 pCO mmHg Torr 5 250 15 4 98 3 pO mmHg Torr 0 800 30 1 488 S 2 ctHb 0 48 27 7 0 1 24 0 4 8 277 0 8 240 Di 0 30 17 2 0 05 14 9 O 2 102 3 3 100 0 FO2Hb 2 102 3 3 98 5 FCOHb 2 102 1 00 92 2 FMetHb 2 102 1 00 91 0 FHHb 2 102 2 4 98 5 FHbF 15 102 21 83 2 H mmol L meq L 0 5 25 2 1 10 5 mmol L meq L 7 350 116 180 cCa mmol L 0 2 9 99 0 50 2 48 meq L 0 4 19 98 1 00 4 96 cGlu mmol L 0 60 O AA cLac mmol L meq L 0 30 O ee om 13 2 ABL90 FLEX opera
79. gt Analyzer Status gt Quality Control Highlight the built in QC solution to run an unscheduled measurement on Press Start QC to start the measurement The Quality control result is shown after the measurement is completed If the built in QC results are outside the acceptable control ranges follow the instructions on the Troubleshooting screen the instructions are also given in Chapter 10 Analyzer messages in the ABL9O FLEX reference manual ABL90 FLEX operator s manual 5 Quality management System checks Description The ABL90 FLEX analyzer performs system checks to verify that the individual components of the analyzer are functioning properly and according to specifications System checks are performed regularly and automatically In this way the ready time is maximized and long termed activities and frequent calibrations are avoided It is not necessary for the user to make any additional checks if this is not requested by the analyzer If the system checks fail they are in most cases retried and if possible remedied automatically by the analyzer If these system checks fail again the analyzer enters the user intervention required or user action needed mode This means that if any interventions actions are required by the user the User Intervention Required or the User Action needed screen appears with Instructions on what to do to in the particular case The system checks consist of the following checks e Comp
80. iece of the inlet ABL90 FLEX operator s manual 7 Replacements Step Action 1 Pull off the inlet cover as shown 2 Lift the inlet handle to syringe position the middle LED lights up 3 Pull off the inlet Dispose of the used inlet as infectious waste according to the regulations in your institution 4 Take the new inlet Place your thumb and index finger as shown and press the two parts together 5 While pressing the two parts together put the black inlet connector over the pin in the recess until a click is heard 7 Replacements Replacing inlet probe gasket Step 1 Action Pull off the inlet cover as shown Lift the inlet handle to syringe position the middle LED lights up Pull off the inlet Pull out the holder CAUTI ON Risk of infection Be aware that the inlet gasket has been in contact with blood and should be handled as potentially infectious Lift the probe 90 upwards and remove it from its recess CAUTION Risk of infection Be aware that the probe has been in contact with blood and should be handled as potentially infectious ABL90 FLEX operator s manual ABL90 FLEX operator s manual Replacing the Step inlet connector 1 gasket 7 Replacements Insert the probe into its recess and place it back into normal position Remount the holder by inserting it into the inlet holder hole just beneath the probe and placing the probe in the
81. ient identification Entering information with barcode reader Entering information manually Patient ID Patient Last name Geller Patient first narne James Sample type 7 Reci Step Arterial 37 0 dE is Shee ue te ENEG Pm si i Action Activate the Enable general barcode support function in the Miscellaneous setup if not done already see chapter 1 Setup in the ABL9O FLEX reference manual Scan all barcodes if available e g Accession no Sampler ID Patient department Patient last name etc See Barcode reader in section Hardware chapter 2 What is what in the proper field Scan Operator or Physician from your ID card if available e If the name is included in the list of the analyzer s registered users the barcode will identify the person and fill in the name automatically depending on the selected input layout e If the name is not included in the list of the analyzer s registered users only the barcode will be read from the ID card Action i Highlight the desired input field in the Patient identification list the top box is already highlighted when the Patient identification screen appears Type in the patient information using the screen keypad or keyboard and confirm each entry with the Enter button e If a patient ID has been used before or is included in the Patient profile log the relevant input fields will be filled in automatically see section Patient profi
82. iew the plot for the highlighted QC solution 3 5 3 Analyzer status Replacements A calibrations salirane Si jaliy cantal m Oe kepacenents ATEN As System Replace 12 24 Activities 340 Replace 12 24 Tests 240 Replacement components message 3 6 ABL90 FLEX operator s manual Replace 12 24 Replace 12 24 Activites 340 Tests 240 REGIE Stats Solution pack status replacement due date and the number of remaining activities Sensor cassette status replacement due date and the number of remaining tests The printer paper is to be replaced as needed Messages if present referring to an activity ABL90 FLEX operator s manual 3 Analyzer status Buttons e Replace Press to select one of the replacements e Status Press to see status and replacement reasons of the consumable selected e Troubleshoot Press to get troubleshooting information for the message in question Replacement procedures see chapter 7 Replacements Other activities Here it is possible to view the scheduled replacements and user activities see Replacement schedule setup and User activities in section Replacement setup in chapter 1 Setup in the ABL9O FLEX reference manual and to see if any of the activities are overdue To see only overdue replacements user activities press Reminders only System messages Here it is possible to view and remedy analyzer messages
83. information to the Patient identification screen and return to the previous screen Or e Press Back to return to the previous screen without updating the patient information Action Highlight Report layout with the up down arrows on the Patient identification screen e Report layout is included in the Patient ID Select a layout from the list displayed on the right side of the screen using the up down arrows The list of report layouts has been made in the Patient report setup see Patient report setup in section Analysis setup in chapter 1 Setup in the ABL9O FLEX reference manual e Report layout is not included in the Patient ID Highlight the line on the Patient identification screen the input field is separated from the rest of the items on the screen and select the desired layout The patient report will be saved in this layout Data not shown in the layout selected will still be archived Action Press Parameters on the Patient identification screen Deactivate the relevant check button to exclude a parameter e Press Back to return to the Patient identification screen e Press Result to display the changed result e Press Print to print out the changed patient report NOTI CE The Selected parameters screen displays all the parameters selected in the Parameter profile for a given measuring mode ABL90 FLEX operator s manual 4 Sample measurement Determining FShunt and ctO2 a v Calculation of ponuneene to
84. inlet 5 Enter the information needed on the Patient identification screen 4 5 4 Sample measurement ABL90 FLEX operator s manual Introducing a blood sample with a safePl CO sampler with barcode and sample pre registration 4 6 Step 1 Action Check that the analyzer is in the Ready mode and scan the sampler barcode see Barcode reader in section Hardware chapter 2 What is what Do not remove the safeTI PCAP If Sample pre registration has not been selected Proceed to step 3 below e If Sample pre registration has been selected in the Sample pre registration setup see section Sample pre registration setup in chapter 1 Setup in the ABL9O FLEX reference manual Proceed to step 3 below to start the measurement or press Cancel to cancel the displayed patient data Lift the inlet to the syringe position and follow the on screen instructions Do not remove the safeTI PCAP ABL90 FLEX operator s manual Step 4 Sample measurement Action Place the safeTIPCAP tip firmly against the inlet gasket and press it upwards while still holding on to the sampler cylinder The inlet probe extends into the syringe and the blood is automatically aspirated NOTICE Be careful not to bend the probe Hold on to the syringe barrel and do not press the plunger NOTICE Make sure that the plunger is not pushed back by the probe NOTICE When aspirating small blood volumes less than PICO50 samplers 1 1 m
85. inlet gasket making sure that it can move freely through the gasket Place your thumb and index finger as shown and press the two parts together While pressing the two parts together put the black inlet connector over the pin in the recess until a click is heard Put the inlet handle in the closed position and remount the cover Action Pull off the inlet cover as shown 7 Replacements ABL90 FLEX operator s manual 2 Lift the inlet handle to syringe position the middle LED lights up 3 Pull off the inlet 4 Remove the gray gasket by pulling it out Dispose of the used gasket as infectious waste according to the regulations in your institution 5 Put a new gasket into the hole mp u and press it firmly into position N t NOTI CE To reduce the friction you can apply demineralized water or alcohol to the gasket before putting it into the inlet connector hole 6 Place your thumb and index finger as shown and press the two parts together ABL90 FLEX operator s manual 7 Replacements While pressing the two parts together put the black inlet connector over the pin in the recess until a click is heard Put the inlet handle in the closed position and remount the cover 7 Replacements ABL90 FLEX operator s manual Cleaning the analyzer The analyzer surfaces should always be kept clean of blood and or other liquids Immediately clean all surfaces if they become cont
86. installed The sensor cassettes are available in the following parameter configurations BG OXI QC pH pCO pO ctHb sO FO2Hb FMetHb FCOHb FHHb FHbF BG LYT OXI QC pH pCO gt pO cCa cC cKt cNa ctHb SO gt FO2Hb FMetHb FCOHb FHHb FHbF BG LYT MET OXI QC pH pCO gt pO gt cCa cC cK cNa cGlu cLac ctHb sO FO gt Hb FMetHb FCOHb FHHb FHbF For further details on the different sensor cassette variants see section Analyzer accessories in chapter 14 Ordering information All solutions necessary for the daily operation of the ABL9O FLEX analyzer are contained in the solution pack e g calibration rinse and quality control solutions Apart from solution consumption in connection with a test solution is consumed during a number of automatic activities e g calibration and quality control that runs at fixed intervals The solution pack contains solutions for 600 activities tests and automatic activities and has a max lifetime of 30 days The analyzer performs 12 auto activities per day This means that the higher the daily sample volume is the more tests can be performed per solution pack and the shorter the lifetime The analyzer should be used by personnel trained in using in vitro diagnostic medical devices NOTICE Documentation must be consulted Failure to follow the instructions in the manual may result in damage to the analyzer Radiometer will not accept warranty claims
87. iodic system checks and continuous analysis checks to provide further confidence in the fact that the analyzer is performing according to specifications see descriptions later in this chapter Built in QC measurements are by default performed every 8 hours Additional Quality controls should be run after all troubleshooting or preventive maintenance procedures that may alter the performance of the analyzer or whenever a service technician has doubts about the performance of the analyzer It is also possible to run manual QC with glass ampoules and to start an unscheduled built in QC measurement see later in this chapter QC should be performed according to e internal quality assessment procedures e local state or federal regulation The following terms are used in the quality management Term Explanation Accepted result A measurement value which falls within the statistics range Assigned value The assigned value is the center value of the control range target value Control range The range within which a measurement should fall Typically the control range is set to be the mean 2 SD see section Quality control setup in chapter 1 Setup in the ABL9O FLEX reference manual This range can be set by using the lot to date range 2 SD calculated by the analyzer or it may be user defined Insert range The upper and lower control ranges are established by Radiometer On built in QC they are given automatically when the solution
88. iometer logo ABL AQT TCM RADIANCE AQURE PICO CLINITUBES and QUALICHECK are trademarks of or used under license by Radiometer Medical ApS O 2013 Radiometer Medical ApS All rights reserved End user license agreement for the ABL90 FLEX analyzer You have acquired a device DEVICE THAT INCLUDES SOFTWARE LICENSED BY Radiometer Medical ApS from Microsoft Licensing Inc or its affiliates MS Those installed software products of MS origin as well as associated media printed materials and online or electronic documentation SOFTWARE are protected by international intellectual property laws and treaties The SOFTWARE is licensed not sold All rights reserved IF YOU DO NOT AGREE TO THIS END USER LICENSE AGREEMENT EULA DO NOT USE THE DEVICE OR COPY THE SOFTWARE INSTEAD PROMPTLY CONTACT THE SUPPLIER OF THE INSTRUMENT FOR INSTRUCTIONS ON RETURN OF THE UNUSED DEVICE S FOR A REFUND ANY USE OF THE SOFTWARE INCLUDING BUT NOT LIMITED TO USE ON THE DEVICE WILL CONSTITUTE YOUR AGREEMENT TO THIS EULA OR RATIFICATION OF ANY PREVIOUS CONSENT GRANT OF SOFTWARE LICENSE This EULA grants you the following license e You may use the SOFTWARE only on the DEVICE e NOT FAULT TOLERANT THE SOFTWARE IS NOT FAULT TOLERANT RADIOMETER MEDICAL ApS HAS INDEPENDENTLY DETERMINED HOW TO USE THE SOFTWARE IN THE DEVICE AND MS HAS RELIED UPON RADIOMETER MEDICAL ApS TO CONDUCT SUFFICIENT TESTING TO DETERMINE THAT THE SOFTWARE IS SUITABLE FOR SU
89. ions see section Warm start in chapter 10 Analyzer shutdown ABL90 FLEX operator s manual 6 Calibration Pending calibrations Expired calibrations A calibration is pending when a scheduled calibration cannot be performed at its scheduled time because the analyzer is occupied with another activity e g measurement A pending calibration e iS indicated by a clock symbol next to it on the Analyzer status gt Calibrations screen as a warning e will be performed 3 minutes after the analyzer has returned to the Ready mode and been without any activity If more than one type of calibration are pending the highest priority calibration is performed The calibrations are given in descending order of priority the full calibration having the highest priority A scheduled QC measurement will be postponed until the calibration has been performed A calibration has expired and is considered invalid when e a sensor cassette is replaced e If a calibration is 25 overdue Under these conditions a Cal expired parameter message appears in the Activity and System messages logs and the replaced item is also recorded in the Activity log The analyzer status in the status bar is RED 6 3 6 Calibration tHb calibration ABL90 FLEX operator s manual Purpose This calibration is used to adjust the analyzer s optical system cuvette factor and wavelength It is recommended that a tHb calibration is performed every three months o
90. is identified as follows Indicates the status of the QC measurement e OK a successful measurement e an error detected or a measured value exceeded a control or statistical range or range of indication Interrupted a measurement stopped by the operator Aborted a measurement stopped by the analyzer most likely due to insufficient sample 9 9 9 Data management ABL90 FLEX operator s manual The following functions are available by activating a button aa Sample measurement for detailed information Filter Seebelow o Plot See below Statistics Seebelow o Quality control plot Slot A 59030 Slot C S9050 Salar Amageuls A RESTE Ml a pS e Print Bl Bos Poara GS A Prin The details of a typical plot are as follows Slot number Solution type Control range upper limit Slot A S9030 Out of range symbol rss id Date Time Measured value 7154 Control range lower limit 9 10 ABL90 FLEX operator s manual 9 Data management Explanation Shaded block Shows date time and measured value for the highlighted measurement Use the up down arrows to scroll the plot and view other measurements Control range Shows the upper and the lower limits of the control range limits for the highlighted measurement Dots Shows the number of measurements for the selected parameter To view a measurement result highlight a dot on the sc
91. is not universal in the literature and depends on puncturing device and technique However increasing capillary blood flow may be necessary to prevent hemolysis and or contamination with tissue fluids 12 Make the puncture with a lancet or similar so that blood flows freely Do not squeeze the area Remove the first drop of blood since it may be diluted with tissue fluid Visually inspect the sample for air bubbles Right after sampling and before mixing tap the sampler to move any bubbles to the top of the sampler and gently press the plunger to expel any air from the sampler Arterial blood gas samplers with vented tip caps that will allow you to expel air and seal the sampler with least possible contact with blood are available from Radiometer Use heparin exclusively as this is the only anticoagulant suitable for blood gas testing Use dry preheparinized sampling devices Mix the sample immediately after Sampling to dissolve the heparin See also the text on heparin earlier in this table Blood gas analyzers with automatic mixing prior to measurement arterial blood gas samplers with a ball for mixing and capillaries with a mixing wire are available from Radiometer Do not store the sample directly on ice cubes Do not mix vigorously Avoid turbulence in the sample caused by a too narrow needle diameter obstruction in sample pathway and too rapid manual aspiration Avoid squeezing the tissue during S
92. is procedure should be repeated immediately before analyzing the sample Neonatal and fragile samples e Invert the capillary tube slowly 20 times Allow the mixing wire to move all the way from end to end with every single inversion 12 3 12 Sampling ABL90 FLEX operator s manual Fetal scalp samples e When performing capillary blood sample measurements on fetal scalp blood insert the mixing wire into the capillary tube after the sample has been collected e When performing measurements on fetal scalp blood introduce the capillary sample into the analyzer from the cap end free from Vaseline or similar e Due to their inherent characteristics fetal scalp blood samples are generally regarded as potentially difficult to work with Important prerequisites for successfully analyzing fetal scalp blood samples are that the preanalytical precautions listed in section Causes of error in the preanalytical phase are followed very closely below 12 4 ABL90 FLEX operator s manual 12 Sampling Storage time and temperature recommendations Radiometer For all samples storage should be avoided whenever possible or at least kept storage to a minimum recommenda tions for whole blood Material Storage recommendation samples Plastic syringe If it is not possible to analyze the sample immediately analyze it within 30 minutes 1 2 3 4 5 6 7 Recommended sample storage temperature is room temperature 1 2 4 Samples with ex
93. ise highlight the desired item on the screen and confirm with the Enter button 2 Enter the ambient temperature default 25 C on the keypad and confirm with the Enter button Mandatory entry is indicated by a cae 3 Enter Department on the keypad and confirm with the Enter button 4 Enter Operator on the keypad or keyboard and confirm with the Enter button filled in automatically when operator is logged on The measured values are compared with the defined control range statistics range and range of indication and then given a status mark accordingly NOTI CE The user defined corrections slope and offset do not influence the quality control results unless the Apply parameter corrections to QC function has been activated in Miscellaneous setup see section Miscellaneous setup in chapter 1 Setup in the ABL9O FLEX reference manual In most cases the Quality control result screen will be displayed automatically when the measurement has been completed However if the QC identification took longer time to enter than the measurement you can press Result e on the Quality control identification screen e from Menu gt Analyzer status gt Quality control e from the Quality control log The absence of any markings next to a parameter indicates that a parameter was measured without fault For an explanation of possible parameter markings please refer to Parameter status in section Built in quality control earlier in
94. l TALOLAN ON aaciaee otr Game Mane ete ede leonel 10 2 Temporary SNUEGOWN prierai A A A A coker 10 3 Restarting the analyzer after temporary SNHUtTGOWN ccceeeeee eee e eens 10 4 Long term SHULGOW Ni ici IA AAN AA AE 10 6 10 1 10 Analyzer shutdown ABL90 FLEX operator s manual General information Shutdown To access the Shutdown programs press Menu gt Utilities Then press the programs desired button to enter the desired program e Temporary Shutdown e Long term Shutdown 10 2 ABL90 FLEX operator s manual 10 Analyzer shutdown Temporary shutdown Purpose This program prepares the analyzer software for switching off power and is used for temporary short term shutdown of the analyzer This program differs from the Long term shutdown used for a long term storage of an analyzer that requires removal of system components Switching off the analyzer for a short time Step Action 1 Enter the program 2 e Press Confirm shutdown to continue e Press Close to cancel 3 Wait for the analyzer to automatically shut down 10 3 10 Analyzer shutdown ABL90 FLEX operator s manual Restarting the analyzer after temporary shutdown Warm start 10 4 Step Action 1 Verify that the system requirements are met and all components are installed 2 Place the power switch in the ON position The startup procedure begins Startup includes e Loading of software e Leak test e Initialization e Liquid
95. lary blood specimens approved standard Fifth Edition CLSI NCCLS document H4 A5 Clinical Laboratory Standards Institute 940 West Valley Road Suite 1400 Wayne Pennsylvania 19087 1898 USA 2004 13 Clinical laboratory waste management CLSI NCCLS document GP5 A2 Clinical Laboratory Standards Institute 940 West Valley Road Suite 1400 Wayne Pennsylvania 19087 1898 USA 14 Skurup A Storage recommendations for blood gas samples Radiometer Publication bulletin no 31 2006 Copengagen Radiometer Medical A S Code no 918 686 12 9 12 Sampling Recommended literature 12 10 10 11 12 13 14 15 16 17 18 19 ABL90 FLEX operator s manual Capillary sampling In The whole blood sampling handbook Copenhagen Radiometer Medical ApS 2003 Code 989 466 Christiansen TF Heparin and blood sampling for pH blood gases and direct potentiometric electrolyte analysis Radiometer Publication AS96 Copenhagen Radiometer Medical A S 1986 The blood gas handbook Copenhagen Radiometer Medical ApS 2004 Code 989 318 Bower LK Barnhart SL Betit P Hendon B Masi Lynch J Wilson BG AARC Clinical practice guideline Capillary blood gas sampling for neonatal and pediatric patients Respir Care 1994 39 12 1180 83 Moran RF Bergkuist C Graham GA et al Considerations in the simultaneous measurement of blood gases electrolytes and related analytes in whole blood Proposed Guideline CLSI NCCLS Pu
96. lements in the center section of the screen names of the columns e g Status input fields e g Draw time etc 2 What is what Interaction tools check buttons ABL90 FLEX operator s manual With the check buttons you can enable disable or select deselect an item on the screen For example open or activated Interaction tools screen keypad A parameter is selected A function is selected e g acoustic signal if the inlet remains A function is deselected or deactivated A parameter is deselected Keypad with numerical buttons Depending on the screen the decimal point may be absent e g Time Date setup Press the Backspace button to delete a character from right to left The box is cleared as soon as the first character is typed Press Enter or Select in some cases to confirm a numerical entry and to highlight the next line in the text box To get access to an alphanumerical keyboard press the keyboard icon ABL90 FLEX operator s manual 2 What is what Interaction tools screen keyboard ontane 2 Spontaneous RR To enter alphanumerical text key in the text and press Enter to confirm the entry and to return to the analyzer screen To return to the previous screen without making any entries changes to already entered text press Esc Bottom section Buttons e Each button has an icon and a name placed on it When pressed it opens or closes a screen or a menu
97. les log chapter 9 Data management in this manual e Press Patient lookup if available to obtain the latest information about your patient see the Patient lookup function below ABL90 FLEX operator s manual Step 3 4 Sample measurement Action The analyzer is connected to LIS HIS e Type in the Patient ID or Accession number If automatic data request has been selected in Communications setup see Automatic data request setup in section Communications setup in chapter 1 Setup in the ABL9O FLEX reference manual the relevant input fields will be automatically filled in with data received from LIS HIS Or e Press Request if available after the patient ID or Accession number has been entered to fill the relevant text boxes ES Fill in all the mandatory with a next to it text boxes to view the measurement results If desired select another report layout see next page section Selecting a report layout NOTICES If the requested patient data e g Patient last name was received after the Patient identification screen was exited the patient report will be transmitted without the requested data To prevent this select one of the patient ID items transferred from LIS HIS as mandatory e If the requested patient data e g Patient last name was received after the Patient identification screen was exited the patient report will be stored without the requested data in the Patient report log The d
98. lood is automatically aspirated when the inlet gasket is pushed inwards WARNING Risk of A erroneous results Gently press the inlet gasket totally in to make sure that the Sample is aspirated correctly i e from the whole sample and not just the tip of the capillary tube Otherwise this may lead to erroneous tHb results When prompted by the analyzer remove the capillary and close the inlet Enter the information needed on the Patient identification screen ABL90 FLEX operator s manual 4 Sample measurement Introducing a blood sample with a test tube Step Action 1 Check that the analyzer is in the Ready mode 2 Lift the inlet to the syringe position and follow the on screen instructions 3 Place the test tube opening firmly against the inlet gasket holder and press it upwards while still holding on to the test tube The inlet probe extends into the tube and the blood is automatically aspirated NOTICE Be careful not to bend the probe NOTICE If the inlet probe has difficulties in reaching the blood Sample we recommend that you transfer the blood sample to a smaller test tube or alternatively try to tilt the test tube a little so that the inlet probe can reach into the blood sample 4 When prompted by the analyzer remove the test tube and close the inlet 5 Enter the information needed on the Patient identification screen 4 9 4 Sample measurement ABL90 FLEX operator s manual Entering pat
99. lter function and the Trend function procedures Di Press Back to return to the previous screen 9 17 9 Data management Activity log Purpose ABL90 FLEX operator s manual The Activity log provides a historical record of all replacements system messages and errors during operation It also lists any operator messages and allows the entry of additional notes The records are listed chronologically and can be displayed at user manager or service level 9 17 2009 09 56 AM 9 17 2009 09 56 AM 9 11 2009 07 23 PM 9 11 2009 07 23 PM 9 11 2009 07 22 PM 9 11 2009 07 22 PM 9 11 2009 07 22 PM 9 11 2009 07 22 PM 9 11 2009 07 22 PM 9 11 2009 07 21 PM 9 11 2009 07 21 PM 9 11 2009 07 21 PM 9 11 2009 07 21 PM User logged on Radiometer ABL DMS PC restarted User logged off Radiometer RADIANCE communication disabled RADIANCE communication enabled QA Portal communication disabled QA Portal data transmission failed QA Portal data transmission successful LIS HIS Connection lost Connection 1 User logged on Radiometer Cal expired OXI Cal expired Lac Cal expired Glu Manager The record is identified as follows use the left right scroll bar to see the items Adding a message to the log 9 18 Time Message Date and time when the activity occurred Gives a message number and an explanation of the activity Operator note text appears as written ABL90 FLEX operator s manual Step 9
100. n 1 Press Menu gt Logon on the Main screen 2 Type in the standard password 123456 and confirm with Enter 3 Press Menu to access the complete menu see the previous page See General security in section Analyzer security in chapter 1 Setup in the ABL9O FLEX reference manual for further information about the logon possibilities The access possibilities for each user and their passwords are entered in the Analyzer Security setup programs see section Analyzer security in chapter 1 Setup in the ABL9O FLEX reference manual 2 What is what ABL90 FLEX operator s manual Menu structure When the analyzer is taken into use only the following limited menu is available Press Menu Log on See chapter 2 Latest result Setup See chapter 1 in the ABL90 FLEX reference manual Analyzer status See chapter 3 Calibration programs Start programs Disk functions See chapter 6 See chapter 8 Calibration Sample counter tHb calibration See chapter 1 in the ABL9O FLEX reference manual Temporary shutdown Auxiliar rograms uxiliary prog See chapter 10 Rinse Liquid sensor adjust Long term shutdown Pump calibration See chapter 10 Tubing refill RADIANCE browser See chapter 9 Data logs Patient results log See chapter 9 Patient profiles log Quality control log Calibration log Activity log Replacement log Archived data logs 2 18 3 Analyzer status Analyzer status ata
101. n S7770 ctHb Calibration Solution The calibration can be included in the Calibration schedule Preparation e Check that the analyzer is in the Ready mode e Prepare an ampoule of S7770 ctHb Calibrating Solution an QUALI CHECK adapter and an ampoule opener tHb calibration Step procedure 1 6 4 Action Press Menu gt Start programs gt Calibration programs gt Calibration to perform a calibration Press Menu gt Start programs gt Calibration programs gt tHb calibration to perform the tHb calibration Enter the barcode information from the S7770 insert using the barcode reader see Barcode reader in section Hardware chapter 2 What is what or the keyboard To cancel the program press Close When the barcode has been accepted the following screen appears Tap the top of the S7770 ampoule to collect the liquid at the bottom and break off the ampoule neck using the ampoule opener Place the ampoule fully in the QUALI CHECK adapter Place the adapter tip against the inlet gasket and press the adapter upwards The probe extends into the ampoule and the S7770 ctHb Calibration Solution is automatically aspirated NOTI CE Be careful not to bend the probe When prompted by the analyzer remove the adapter and close the inlet If the calibration results are not accepted remedy the error and perform a new tHb calibration ABL90 FLEX operator s manual 6 Calibration Calibration result Viewing a The result
102. n and or calibration schedule reminders Quality control GREEN OK YELLOW Error s in the last QC measurement and or QC schedule reminders Replacements GREEN No replacements due at the present time aa o A replacement is due Other activities GREEN No activities due at the present time Activity overdue System messages GREEN No critical messages YELLOW Non critical messages RED Critical messages The analyzer cannot calibrate or measure 3 3 3 Analyzer status ABL90 FLEX operator s manual Calibration status Calibration Type Lists the most recently performed calibration of each type and its status Calibration was accepted aa Error s detected during calibration Pending or overdue calibration The last calibration was accepted Pending or overdue calibration The last calibration was not accepted Last time The date and time that the last calibration of the specified type was performed Next time The date and time that the next calibration of the specified type is due according to the calibration schedule see section Calibration schedule setup chapter 1 Setup in the ABL90 FLEX reference manual Interval The time interval between calibrations as set up in the calibration schedule Message Messages if present referring to a highlighted calibration Buttons e Result Press to see results e Calibration Press to start a highlighted calibration 3 4 ABL90 FLEX operator s manual 3 Analyzer s
103. ng Step Action 3 Press Troubleshoot for error description and operator action 606 Cal expired pH Interpretation Too long time passed since the last successful calibration of the parameter Parameter measurement values are reported as Action Perform a calibration Removal Condition s Successful calibration E Seine 4 Remedy the error as described in the troubleshooting dialog on the screen 5 Remedy other error s if present After all errors have been remedied press Back and Close till you return to the main screen NOTI CE For a list of the analyzer messages interpretations and operator actions that can be seen on user and manager levels see chapter 10 Analyzer messages in the ABL9O FLEX reference manual Logging All system messages are automatically recorded in the Activity log at the time of system their occurrence The items in the Activity log are listed in chronological order messages and form a permanent record for the user of all system messages that have taken place Using the filter function see the description in section Activity log in chapter 9 Data management you can select the desired type of messages and view them on the user manager and service levels 11 3 11 Troubleshooting ABL90 FLEX operator s manual User intervention required causes Purpose User intervention required mode is used to correct errors by suspending all wet section activities in case the f
104. ollowing analyzer conditions occur e Problems with the inlet leaking e Solution transport errors e g leakage e Problems with sensor cassette or solution pack e Thermostatting errors e HW SW errors e Misc calibration errors e Other unexpected situations Follow the on screen instructions It might require several actions to correct the condition Until the condition has been corrected the analyzer cannot be restarted e Press Test again to leave the User intervention required screen 11 4 12 Sampling Sampling devices and procedures ooccccccccccccccccccnanccnn narrar 12 2 Storage time and temperature recOMMeEndatiONS ccccceee cece eee eeeeeeeeeeeees 12 5 Causes of error in the preanalytical PNASE cc eccccce cece eee eeeeeeeeeeeeeeeeeeneeaas 12 6 REISTE CE Suisiana O ON 12 9 12 1 12 Sampling ABL90 FLEX operator s manual Sampling devices and procedures Introduction Recommended arterial blood samplers Recommended capillary blood samplers 12 2 Typically whole blood arterial or venous specimens are obtained by needle puncture or via an in line catheter whole blood capillary samples are obtained from the earlobe finger heel scalp etc For specific information on the clinical value of the blood samples from each of the sampling sites for indications and contraindications on when to use them etc please consult other sources A WARNING Risk of infection Blood sampling
105. on se MEUBIES Sif andor 1 Press Menu gt Analyzer status gt Replacements gt Status 2 Choose one of the following options e Send status to printer e Sensor status e Solutions status For a printout of the consumables status showing the replacement information of the solution pack and the sensor cassette such as date of installation scheduled replacement date reason for the replacement time for next replacement expiration date number of blood and QC measurements performed and number for samples remaining Shows replacement information such as date of installation scheduled replacement date reason for the replacement time for the next sensor cassette replacement when a new sensor should be conditioned how many tests have been performed and when the sensor cassette expires Shows replacement information such as date of installation scheduled replacement date reason for the replacement time for the next solution pack replacement the lot number of the solution pack how many activities have been performed and when the solution pack expires 3 Press Back to return to Analyzer Status screen 4 Press Close to return to the main screen 7 3 7 Replacements Solution pack Replacing Step solution pack 1 7 4 ABL90 FLEX operator s manual Action Press Menu gt Analyzer status gt Replacements gt Replace gt Replace solutions Lift the inlet to the capillary position
106. on information took longer to enter than the measurement you can do one of the following e Press Result on the Ready screen e Press Menu gt Latest result e Press Menu gt My results e Press Menu gt Data logs gt Patient results log highlight the desired result and press Result Blood gas values cel 110 mmol L pH 7 412 pCO 41 5 mmHg Metabolite values pO 86 3 mmHg cGlu 8 0 mmol L cLac 0 6 mmol L Oximetry values ctHb 15 1 g dL s0 97 3 FO Hb 95 5 FCOHb 1 3 FHHb 2 7 FiMetHb 0 5 FHbF 61 Electrolyte values ckt 3 6 mmol L cNat 142 mmol L cla 1 21 mmol L A 1D Mlassaros ft SENG WA Calbration Seine P No marking next to a parameter indicates that a parameter was measured without any fault The following markings may appear next to a parameter e Error in the last quality control measurement or calibration or because of sample problems Sample age selected for the given parameter s in Sample logistics setup see Sample age evaluation setup in section Analysis setup in chapter 1 Setup in the ABL90 FLEX reference manual was exceeded Parameter value is outside the reference range the range within which the parameter value is considered normal for the specific type of sample being measured but inside the critical limits Parameter value is outside the upper or lower critical limit the limits outside of which a parameter value is dangerously high or low for the specific t
107. ontra 5 9 Mantal q UaltySCOntrOl urraca rotor A AE 5 9 Adartional QuUAlIEY CONTO idos 5 13 5 1 5 Quality management ABL90 FLEX operator s manual Automatic quality management system 5 2 With the ABL9O FLEX quality management system all necessary checks are done automatically and continuously by the analyzer If the result of the check is not acceptable the analyzer automatically performs a corrective action unless a user intervention action is required Checks and corrective actions are logged in the activity log of the analyzer and can be obtained if documentation is needed The quality management system is based on the following checks e Built in QC e System checks e Analysis check performed before under and after each activity Quality management is performed on six different solutions that are all built into the solution pack Three solutions CAL1 CAL2 CAL3 are used for calibration analysis check and system check and three solutions QC1 S9030 QC2 S9040 and QC3 S9050 are used for quality controls ABL90 FLEX operator s manual 5 Quality management General information Purpose Glossary list The purpose of quality control is to evaluate the performance of the analyzer to ensure the reliability accuracy and precision of patient sample results Quality controls are run automatically on the built in solutions in the solution pack Furthermore the ABL9O FLEX analyzer automatically performs per
108. ontrol in chapter 5 Quality management of this manual 2 Hold the ampoule between your thumb and first finger and shake it vigorously for a minimum of 15 seconds 3 Hold the ampoule neck side up and tap the top until all solution collects in the lower part of the ampoule 4 Put the ampoule in the Ampoule Opener and break off the neck of the ampoule Put the QUALICHECK Adapter over the open end of the ampoule Check that the analyzer is in the Ready mode Lift the inlet to the syringe position ee ee Tap the Cal Verification button ABL90 FLEX operator s manual 6 Calibration 9 Put the tip of the QUALICHECK Adapter with the ampoule in the center of the inlet gasket f a 10 Push the adapter into the analyzer as far as you can and hold it there NOTI CE Be careful not to bend the probe 11 When the analyzer tells you remove the adapter with the ampoule and close the inlet 12 Sample type Cal Verification Patient ID SER T 37 0 C Operator Radiometer Note RESCUE As Patient ID In the Patient identification screen enter an identifier for each solution e g Level 1 NOTI CE No temperature corrections will be done For manual temperature corrections see Appendix Quality control in the ABL9O FLEX reference manual The results are saved in the Patient results log 13 After all measurements on the calibration verification solutions have been done use the filter function in
109. or product liability claims if the recommended procedures are not followed Animal blood has not been tested on the ABL9O FLEX analyzer Animal blood differs from human blood and variations in the composition of blood from different animal species may also exist ABL90 FLEX operator s manual 1 Introduction Limitations of use and known interfering substances Limitations of use FHbF measurement Known interfering substances The following limitations should be taken into consideration WARNING Clinical decisions The validity of the test results from this analyzer must be carefully examined by a clinician and related to the patient s clinical condition before any clinical decisions are made on the basis of the test results CAUTION Fulfillment of user specific analytical needs Review the analyzer s performance data to ensure that the performance fulfills the user specific analytical needs The uncertainty in FHbF measurements exceeds the level required to measure normal HbF levels in the adult range FHbF reference range is 0 1 FHbF is disabled as default The ABL9O FLEX analyzer measures only HbA and HbF hemoglobins For information on the interfering substances see section Interference tests in chapter 7 Performance characteristics in the ABL9O FLEX reference manual 1 5 1 Introduction ABL90 FLEX operator s manual Symbols used on the analyzer and accessories Product code no UL certification
110. or the highlighted search criteria 4 Select the desired criteria and confirm each entry with Enter Or use the keyboard to enter the desired data and confirm each entry with Enter 5 Press Apply to start the search filter View the search results on the screen Press Back to return to the previous screen 9 4 ABL90 FLEX operator s manual 9 Data management Trend function This function is used to make a trend of the selected parameters for a patient after filter criteria have been applied Step 1 Action Set up search criteria as described under Filter function and apply them The filtered patient results will be displayed and Trend and Print will now be active Press Trend to select the parameter s Press View trend to display the trend of the selected parameter s for the selected patient reports The Patient result log trend screen is shown Press View filter to view the selected filter criteria the criteria cannot be changed only viewed To apply new criteria repeat the Filter function and the Trend function procedures Press Back to return to the previous screen 9 5 9 Data management ABL9O FLEX operator s manual Patient profiles log About a patient A patient profile is a record containing general information about a particular profile patient It is created automatically whenever a new patient ID is entered during measurement and recorded in the Patient profiles log Alternatively
111. pack is installed On manual QC with glass ampoules they are found on the insert provided with each box of control solutions Lot to date range A range calculated by the analyzer from measurements taken on a lot of a particular control solution It is represented by mean 2 SD Range of The range for each parameter that the analyzer physically is indication capable of measuring Refer to Measured parameters chapter 13 Specifications for the analyzer range of Indication for each parameter Statistics factor The factor by which the control range is expanded multiplied by to determine the statistics range The recommended statistics factor is 1 5 Statistics range The range within which a measurement must fall in order to be included in the quality control statistics It is determined by multiplying the control range limits by the entered Statistics factor It is typical that the statistics range is set to the mean 3 SD 5 3 5 Quality management ABL90 FLEX operator s manual For detailed information on terminology and principles for the quality control systems see Appendix Quality control in the ABL9O FLEX reference manual 5 4 ABL90 FLEX operator s manual 5 Quality management Built in quality control Schedule Acceptable ranges Built in QC measurement View built in QC results Built in QC measurements are by default performed every 8 hours one on each level The interval of these events can be de
112. pected high pO values or for special studies like shunt studies should be analyzed immediately or within 5 minutes The use of glass syringes can also be considered 1 3 4 Glass syringe If it is not possible to analyze the sample immediately analyze it within 30 minutes when stored at room temperature 1 8 Alternatively store the sample in ice water 0 4 C The storage time should not exceed 1 hour 9 Samples with expected high pO values or for special Studies like shunt studies should be analyzed immediately or within 5 minutes 9 Plastic capillary If it is not possible to analyze the sample immediately tube analyze the sample within 10 minutes Keep the sample at room temperature Note that for samples with pO gt 80 mmHg 10 7 kPa a positive bias from 1 to 9 is observed for safeCLINITUBES The bias depends on pO pH and time Glass capillary If it is not possible to analyze the sample immediately tube either analyze the sample within 10 minutes when stored at room temperature or store the sample horizontally at 0 4 C for maximum 30 minutes Special e For some samples the recommendations above do not apply and individual considerations guidelines should be used or developed Examples of these samples are Samples with an increased leukocyte or platelet count fetal scalp samples Samples with atypical metabolism fast clotting samples etc 5 10 e Typical metabolic activity in blood samples causes an in
113. rallel to the barcode reader A short beep indicates that the information has been read successfully Barcodes are found on the following ABL90 FLEX accessories Item Barcode position Sensor cassette The label on the sensor cassette pack QC ampoules The insert in the box with ampoules tHb calibration The insert in the box with ampoules ampoules Sampler On the syringe cylinder The barcode information may also be entered manually in the input fields on the Patient profile Patient I D QC solutions and Replacement screens see section Miscellaneous setup in chapter 1 Setup in the ABL9O FLEX reference manual ABL90 FLEX operator s manual Consumables 2 What is what Sensor cassette pack with sensor cassette Sensor cassette pack The sensor cassette comes in a sensor cassette pack For further information about how to remove the sensor cassette from the sensor cassette pack see Sensor cassette in section Replacements in chapter 7 Replacements in this manual Sensor cassette Reference lid Electrical contact to sensors Oxygen sensor 2 9 2 What is what ABL90 FLEX operator s manual Solution pack 1 Biohazard label Before installation of the solution pack remove the top cover of the label on top of the solution pack so that the biohazard label appears to remind you that the solution pack must be disposed of as infectious waste after use 2 Safety pin To activate a new solution pack remove the sa
114. rator s manual 14 Ordering information Line cord 230 V ZAF and IND 615 318 Other a Thermal paper 8 rolls Hypochlorite solution Inlet gasket with holder Inlet probe Inlet connector gasket Tubing for valve 841 797 Disposable Clot Catcher for the ABL90 FLEX 906 026 analyzer ABL90 FLEX operator s manual US version 995 656 ABL9O FLEX reference manual US version 995 657 14 3 14 Ordering information ABL90 FLEX operator s manual Quality control Ampoule opener 920 712 QUALICHECK adapter 924 646 QUALICHECK tray 887 860 QUALICHECK5 Item Code Now Type solution Level 1 RED 944 017 S7730 Level 2 YELLOW 944 018 S7740 Level 3 BLUE 944 019 S7750 Level 4 GREEN 944 020 S7760 QUALI CHECK Level 2 944 152 S7940 Level 3 944 153 S7950 QUALI CHECK Documentation Item Code Now QUALICHECK short form instructions 989 313 14 4 ABL90 FLEX operator s manual 14 Ordering information Sampling devices gas samplers i PICO50 2 mL aspirator 0 5 2 0 mL 100 units 956 552 PICO50 PICO70 w o needle 0 3 1 5 mL 100 units 956 518 PICO70 PICO70 w o needle w o needle cube 0 3 1 5 mL 956 519 PICO70 100 units PICO70 22G x 1 0 3 1 5 mL 100 units 956 522 PICO70 PICO70 22G x 1 1 4 0 3 1 5 mL 100 units 956 525 PICO70 PICO70 23G x 5 8 0 3 1 5 mL 100 units 956 529 PICO70 PICO70 23G x 1 0 3 1 5 mL 100 units 956 533 PICO70 PICO70 23G x 1 1 4 0 3 1 5 mL 100 units 956 534 PICO
115. rature correcti0nNS o 5 12 tHb calibratiON occccccccccccncnnnnncnoos 6 4 Procedure iniciara 6 4 DUFPOSE iiiaio 6 4 TOD analyzer ueia eeN 2 3 Trend function Calibration lo9 cooccccccccccccnno so 9 17 Patient results log 0 o ooo 9 5 OG Md a eee 9 11 TroubleshootinQ ccccccccccccccnccannnnos 11 1 analyzer action in case of error 11 2 general informati0N oco occcco 11 2 Logging system messages 11 3 operator actions in case of error 11 2 User intervention required causes11 4 U Unknown solutions QC 5 12 Unscheduled AutoCheck Measurement rata rasbaras 5 6 Unscheduled calibration 6 2 Use rs AAA aa nee a ee ee 1 3 LIMITATIONS oo cece cece cece tananan 1 5 User intervention required causes 11 4 yv View manual QC results 5 11 W What is WN date 2 1 barcode reader sida 2 8 built in Sample MIXET oococcccccccccooo 2 7 O A O eae A 2 2 Hardware cccceccaeccuccueceueeueenans 2 2 inlet MOCUIE cc cece eee eeeeeeeeeeaees 2 6 O ue ee ee ee ee 2 4 O O 2 3 ABL90 FLEX operator s manual Date of issue Date of issue Radiometer representative Manufacturer RADIOMETER 8 Radiometer Medical ApS If you have any questions Akandevej 21 or need assistance 2700 Br nsh j Denmark please contact your local ties Gail amish ey dam Radiometer representative ABL90 FLEX operator s manual
116. rchives are archived after date 500 reports from each log and 2000 entries from the Activity log NOTICE The total number of results and messages in a log can be changed to suit your needs An increase in the total number will require more space and possibly additional disks when backing up data Contact a qualified service technician for details Archived data logs To avoid loss of old data it can be archived into respective archived data logs Press Menu gt Data logs gt Archived data logs to access the archived Patient results log Quality control log Calibration log and Activity log 9 2 ABL90 FLEX operator s manual Patient results log 9 Data management Purpose The Patient results log is a historical file of patient reports automatically saved in the Patient report log after a measurement 3 12 2009 02 10 PM 3 12 2009 02 10 PM 3 12 2009 02 09 PM 3 12 2009 02 09 PM 3 12 2009 02 09 PM 3 12 2009 02 09 PM 3 12 2009 02 09 PM 3 12 2009 02 08 PM 3 12 2009 02 08 PM E masaje Each patient result is identified by Prof Test OK Capillary OK Venous OK Arterial Prof Test OK Capillary OK Venous OK Arterial Prof Test OK NN Ww ho Ds WO laten a ET Se Prine Smith Reid Goodman Ray Roy Geller Smith Reid Goodman Date and time of the sample measurement Sample Sample number Sample type Blood sample type specified in Patient ID Status of the sample measurement Status e
117. reen and press Result Measurement outside both control and Statistical ranges Back Return to the Quality control log screen Use the buttons to do the following View QC result for the highlighted measurement of the highlighted plot Select param View the plot for another parameter Back Return to the Quality control log screen Out of range 4 y Measurement outside the control range and symbols inside the statistical range Filter trend The function is used to set the filter criteria to find a QC result or to select a function number of results to make a trend Solution Lot Department Operator Note Status Select 9 Data management ABL90 FLEX operator s manual Step Action 1 Press Filter on the Quality control log screen 2 e Set the Start date by using the 1 day 7 day 14 day or 30 day icons in the Criteria box Or e Type in the date using the keypad and confirming the entry with Enter Change if necessary the End date by highlighting it and typing a date other than the current date Confirm with Enter 3 Use the up down arrows to highlight the desired filter criteria Solution Lot Department Operator Note and Status 4 Confirm each entry with Select or Enter Or use the keyboard to enter the desired data and confirm each entry with Enter Press Apply Press Trend to select the parameters by activating the check buttons e g pH pCO pO etc and press View
118. rends B Harff G Bosch J Sch nberger J Postmus P Effects of four different methods of sampling arterial blood and storage time on gas tensions and shunt calculation in the 100 oxygen test Eur Respir J 1996 10 910 13 4 Mahoney JJ Harvey JA Wong RJ Kessel VLA Changes in oxygen measurements when whole blood is stored in iced plastic or glass syringes Clin Chem 1991 37 1244 48 5 Woolley A Hickling K Errors in measuring blood gases in the intensive care unit Effect of delay in estimation J Crit Care 2003 18 31 37 Blonshine S To ice or not to ice AARC Times 2000 37 39 Liss P Payne P Stability of blood gases in ice and at room temperature Chest 1993 103 1120 21 8 CLSI Blood gas preanalytical considerations specimen collection calibration and controls Approved guideline CLSI NCCLS document C27 A Clinical Laboratory Standards Institute 940 West Valley Road Suite 1400 Wayne Pennsylvania 19087 1898 USA 1993 9 Burnett RW Covington AK Fogh Andersen N et al Approved IFCC recommendations on whole blood sampling transport and storage for simultaneous determination of pH blood gases and electrolytes Eur J Clin Chem Clin Biochem 1995 33 247 53 10 Nickelsen CN Fetal capillary blood pH www bloodgas org 2002 11 Wennecke G Useful tips to avoid preanalytical errors in blood gas testing metabolites www bloodgas org 2004 12 CLSI Procedures and devices for the collection of diagnostic capil
119. rr ranas 11 4 SampliN as sor EE ead anna te edeewias ai 12 1 Sampling devices and procedures s ssssssrrserrerrirrrrsrrrererrrrerrrerrrrrent 12 2 Storage time and temperature recommendations cccccceceeeeeeeeeeeees 12 5 Causes of error in the preanalytical PNASE ccccee cece cece eee e teense eeeeees 12 6 Retenes tea neat heme ateseatcotass 12 9 SPecifICa CIO Simoca A 13 1 Measured parameter incidir EEE E EEA 13 2 PUED AFANES SES a iaa 13 3 ABL90 FLEX operator s manual Contents Sampe NandliN risa ea tea ica 13 4 Analyzer TeguremMeN S iS eb 13 5 Analyzer SPCCIIICALIONS tala lorod 13 6 ADD Ovals ANGI Daten Saena EEEE AEA AEA A EEEE 13 7 14 Ordering INTOFMATION ica 14 1 Analyzer ACCESSONICS ai dto roda cie ados Esad 14 2 QUANty CONTO td iia 14 4 Samplnd GeCVICCS unicas ati 14 5 Index Date of issue Contents ABL90 FLEX operator s manual 1 Introduction ABL90 FLEX analyzer documentati0ND oocccccccccccncnnccnnnnncnn nan ncn nr rr 1 2 Names and intended Use ii A di 1 3 Limitations of use and known interfering substances cccccccccccccnnnnnnnnnnnnnnnnnoo 1 5 Symbols used on the analyzer and accessories ccceee cece cece sees eeeeeeeeeeeeeeees 1 6 Symbols Used IMER SManNuUd danita oi 1 8 NOTICE The screen shots shown in this manual do not necessarily reflect the screens you will see on your analyzer The screen shots are based on a full parameter panel and some of the screen shots may be
120. rting exporting archives chapter 2 Disk functions setup programs in the ABL9O FLEX reference manual 6 19 2008 6 19 2008 csv format 6 19 2008 6 19 2008 7 Salar A Eiperihee 9 22 Mec a nse ER a archive ive Action Highlight an archive and press Export archive The Destination screen appears Choose directory and press Back The Export archive screen appears e Press Start to start conversion e Press Back to cancel and return to the previous screen Export the converted archive to a disk as described in Importing exporting archives chapter 2 Disk functions setup programs in the ABL9O FLEX reference manual ABL90 FLEX operator s manual 9 Data management RADIANCE browser optional Purpose In the RADIANCE browser you can find information about patients QC and calibrations from all the analyzers connected to the RADIANCE STAT analyzer management system For more information see the RADIANCE user manual Accessing Step Action RADI ANCE 1 Make sure that a connection to the RADIANCE server is established in the RADIANCE connection setup see RADIANCE connection setup in section Communications setup in chapter 1 Setup in the ABL90 FLEX reference manual Press Menu gt Utilities gt RADIANCE browser Refer to the RADIANCE operator s manual on how to navigate the RADIANCE functions 9 23 9 Data management ABL90 FLEX operator s manual 9 24 10 Analyzer shutdown Genera
121. s Analyzer requirements Analyzer Rated voltage 100 240 V 50 60 Hz i t se heb Max power 90 W Maximum voltage fluctuations 10 Relative humidity 20 80 Fuses Main fuse includes two protective fuses 5 x 20 mm 2 5A HRC F 250 VAC Storage Analyzer 20 C to 60 C sera Solution pack 2 25 C Sensor cassette 2 10 C Relative humidity lt 95 Barometric 525 800 mmHg at 15 30 C A P 70 0 106 7 kPa at 15 30 C temperature 0 700 1 067 bar at 15 30 C 525 800 torr at 15 30 C and 600 800 mmHg at 30 32 C 80 0 106 7 kPa at 30 32 C 0 800 1 067 bar at 30 32 C 600 800 torr at 30 32 C Operating temperature 15 32 C Startup Unconditioned sensor cassette approx 30 minutes exclusive MET sensors approx 2 hours inclusive MET sensors Conditioned sensor cassette Not currently available Pollution degree 2 occasional temporary conductivity caused by condensation Ventilation The analyzer must be placed in a well ventilated room to ensure proper calibration of pO The ventilation must be sufficient to ensure that the surrounding atmosphere corresponds to the normal outdoor atmosphere so that the effect from devices that discharge gases to the atmosphere becomes negligible 13 5 13 Specifications ABL90 FLEX operator s manual Analyzer specifications Specifications Solid state 37 0 0 15 C Oxi 0 3 C Hemolyzer Hemolyzation at approximately 30 kHz Perret cay em External serial
122. s electrolytes glucose lactate and oximetry in heparinised whole blood The ABL9O FLEX analyzer is intended for use by trained technologists nurses physicians and therapists It is intended for use in a laboratory environment near patient or point of care setting These tests are only performed under a physician s order In the table below the measured parameters are shown Parameter Parameter group pH blood gas Oximetry Electrolytes Metabolites pH pH acidity FO gt Hb fraction of FOHb fraction of oxyhemoglobin in total hemoglobin in total hemoglobin FCOHb fraction of carboxyhemoglobin in total RE E ESERE ae FHHb fraction of FHHb fraction of deoxyhemoglobin in total hemoglobin in total hemoglobin FMetHb fraction of methemoglobin in total hemoglobin FHbF fraction of fetal hemoglobin cK potassium ion concentration cNa sodium ion concentration cCa calcium ion concentration cCl chloride ion concentration cGlu D glucose concentration cLac L lactate concentration For details on derived parameters see section Derived parameters in chapter 8 Parameters in the ABL90 FLEX reference manual 1 3 1 Introduction Sensor cassette variants Solution pack Requirements to the operator Measurements on animal blood 1 4 ABL90 FLEX operator s manual The ABL9O FLEX analyzer comes with different parameter panels depending on the sensor cassette
123. s and safety hazards The designation of a hazard alert as a warning is reserved for the most significant problems The term WARNI NG is generally used as signal word for this type of hazard alert CAUTI ON The term precaution is used for the statement of a hazard alert that warns the reader of a potentially hazardous situation which if not avoided may result in minor or moderate injury to the user or the patient or damage to the equipment or other property It may also be used to alert against unsafe practices This includes the special care necessary for the safe and effective use of the device and the care necessary to avoid damage to a device that may occur as a result of use or misuse The word CAUTI ON is generally used as signal word for a precaution statement Manufactured by 1 8 2 What is what Hard Ware treated lada sao 2 2 A o O O 2 2 TOP A E As 2 3 O O O 2 4 TINO UNG sit a ad a 2 6 BUI Sample MIO ra 2 7 Barcode read Olarra acia penal tiatenee eas 2 8 EOASUMADISS odo 2 9 Sensor cassette pack with Sensor cassette ooccccccccccccncnnnnnnnnnnnnnnnnn nana 2 9 SOLUTION DA Kad Nara 2 10 A ARCs scooter bende EE ce uae le beaten 2 acid ye evade Mea T yee artes 2 11 Sareen CIEMCNESz suet coth ches acatar oceania 2 11 FEN Misco AAA e A E A Oi 2 17 MENU SEPUCEULG criar reido aros 2 18 2 1 2 What is what ABL90 FLEX operator s manual Hardware Front Adjustable color touch screen Barcode re
124. sor cassette compartment opens Remove the sensor cassette by pulling it out of the sensor cassette compartment with the thumb and index finger and press Confirm removal after removal The sensor cassette compartment closes NOTI CE The sensor cassette cannot be re used 8 Solution pack removal Lift the inlet to capillary position press Eject The solution pack is ejected 9 Remove the solution pack and close the inlet The shutdown procedure is in progress please wait for the analyzer to shut down NOTI CE The solution pack can be re used within its lifetime cycle Radiometer recommends placing the analyzer on a trolley in its normal position and protecting it from dust with a plastic cover Transporting To transport the analyzer over a longer distance from one location to another the analyzer put it back in its original packaging and seal To transport the analyzer without its original packaging remove the solution pack and disconnect power and peripheral devices before lifting the analyzer Restarting the Step Action analyzer l l i A 1 Turn on the analyzer and wait for the User intervention required mode to appear 2 Perform a solution pack replacement see chapter 7 Replacements in this manual 3 Perform a sensor cassette replacement see chapter 7 Replacements in this manual 4 Press Test again For further information about calibrations in connection with startups see section Calibrations relate
125. t oooocccccccccnnnnncnnnno 6 5 Callbtation lO tio ads 9 15 ter TUNC OM aaa 9 16 trend FUNCHOM raras 9 17 Calibration result oocccccccccccnnn caso 6 5 Calibration status serisine 3 4 Calibration verification procedure 6 8 Capillary blood samplers recommended cccceeeeeee eens 12 2 Causes of error in the preanalytical PASS rd 12 6 Check DUO St dosarianiias ias ciencias 2 14 Cleaning analyzer urriei isiin eE 7 16 analyzer exterior 00cccccccccccconnnooo 7 16 analyzer screen ssssserrrerrerenn 7 17 EE eh AT EA A E E re iter 7 16 COMMON NAM recce aeaea 1 3 CONSUIMADIES rdis oiae aaeeea 2 9 Sensor cassette pack with sensor CASSCULC annara aaa 2 9 SOLUTION PACK ivscniinconaasto la 2 10 D Data logs E 9 2 archive 9 2 Data management cccccccccccccccncnncoos 9 1 access to data l09S oocccoccccco ooo 9 2 ACTIVITY o AA otal wetees 9 18 archived data l09S sccceeeeees 9 21 calibration log cccoccccccccccccnno so 9 15 general informatiOn ccceeeee 9 2 patient profiles log 9 6 patient results log 0 oo o 9 3 quality control l0g ooocooo 9 9 RADIANCE browsSer 00eeeees 9 23 replacement 10g cceeeeeeeeeees 9 20 Detachable power supply cord 2 5 DISINFECTION iva can dada 7 18 outer analyzer surfaces 7 18 DISK TUMCEIONS ssariara micas 8 1 general information ccceee es 8
126. t applications See http www radiometer com en legal patents 13 7 13 Specifications ABL90 FLEX operator s manual 13 8 14 Ordering information PE zer ACCESSONICS urna dada 14 2 Qua CONTO ati dio 14 4 Sampling dEV ES coa airada 14 5 14 1 14 Ordering information ABL90 FLEX operator s manual Analyzer accessories Analyzer The following accessories are available on order for the ABL9O FLEX analyzer Sensor Sensor cassettes are available in the following parameter configurations cassette e BG pH pCO pO e LYT cCa cC cK cNa e MET cGlu cLac e OXI ctHb sO FO2Hb FMetHb FCOHb FHHb FHbF The sensor cassettes are valid for a specified number of tests and days Cassette Number of tests over 30 days 946 021 946 020 946 019 946 018 946 017 946 016 946 015 946 014 946 013 946 012 SC90 946 011 946 010 946 005 946 008 946 009 BG LYT MET OXI QC NOTICE Not all versions are available at the time of publication and future variants may be introduced Solution pack tem Cede no Type ABL90 FLEX solution pack 944 157 o o e ctHb Calibration Solution 944 021 S7770 Power cords Code No Line cord 120 V USA and Japan 615 403 Line cord 230 V UK 615 312 Line cord 230 V ITA 615 313 Line cord 230 V DK 615 314 Line cord 230 V ISR 615 315 Line cord 230 V CHE 615 316 Line cord 230 V 615 303 other 230 V countries Line cord 230 V AUS and NZA 615 317 14 2 ABL90 FLEX ope
127. t be accompanied by a Press Messages for the explanation of the error Status 281 91 pA Sens 99 7 fot Messages Sens cuvette factor is a factor that expresses the ratio of the effective light path of the analyzer cuvette to that of a reference cuvette determined by Radiometer The value should lie between 80 and 120 and have no errors i e no in it ABL90 FLEX operator s manual 6 Calibration Calibration Press Messages on the Calibration result screen to display the Calibration result result messages screen messages The message levels can be considered as a type of filter in which the messages displayed are based on the following Explanation Messages for the user familiar with the basic daily operation of the analyzer and primarily responsible for performing measurements This level displays the fewest messages Manager Messages for the user with a deeper knowledge of the analyzer functions and responsible for the analyzer s proper operation Service Messages for the service technician with a thorough knowledge of the operation and construction of the analyzer This level displays the greatest number of messages and in most detail 6 7 6 Calibration ABL90 FLEX operator s manual Calibration verification Purpose Setting up the Calibration Verification mode Calibration verification procedure 6 8 Regulations in some countries require verification of the reportable ranges s
128. tatus Quality control QC Caloranians ee 3132 09 11 01 43 PM 09 18 03 45 AM 9152 09 11 01 46 PM 09 17 11 45 AM gwalty 9152 09 11 01 45PM 09 17 07 45 PM Paanta aa EEE Eee bt DA REE Cemnmento d oiar E activities 09 11 01 45 PM lt 09 11 01 47 PM eee Non R 09 09 09 06 AM A ieSsaqes SS Pasir 499 Seape oe cae OC Plot y a Solution built in or Lists the quality control slot and its solution type along ampoule based with its status al The last measurement was accepted One or more of the following occurred Error in the last calibration Analyzer error during last QC measurement A parameter measurement is outside the defined ranges or a Westgard Rule or RiLiBAK range has been violated if Westgard Rules or RiLiBAK ranges have been selected The next measurement is overdue and the previous measurement if any was accepted The last quality control measurement had errors and the next measurement is overdue Lot The solution lot number for the slot Last time The time that the last measurement was performed Next time The next scheduled time to perform the measurement on the slot see Quality control schedule setup in section Quality control setup in chapter 1 Setup in the ABL90 FLEX reference manual QC messages Messages if present referring to a highlighted QC measurement Buttons e Result Press to see results e Start QC Press to start a QC measurement e QC Plot Press to v
129. ter button Or e Use a barcode reader to scan the patient ID barcode the Enable general barcode support should be activated in the Miscellaneous setup see Barcode reader in section Hardware chapter 2 What is what in this manual 3 Press Find e If a patient profile is found it will be highlighted on the Patient profile log screen e If a patient profile is not found the No item found that matches search criteria message appears in analyzer status Repeat step 2 3 or press Back to cancel NOTICE The patient data entered in the Patient profiles log is also used for Sample pre registration during a measurement 9 8 ABL90 FLEX operator s manual 9 Data management Quality control log Purpose The Quality control log is a historical file of all QC results automatically saved in the Quality control log after a measurement Each QC result is listed in reverse chronological order as an individual record with the most recent result at the top of the screen 9 11 2009 01 47 PM 93 OK 9 11 2009 01 46 PM 92 OK 9 11 2009 01 45 PM 91 OK 9 11 2009 01 45 PM 90 OK 9 11 2009 01 44 PM 89 OK 9 11 2009 01 44 PM 38 OK 9 11 2009 01 44 PM 87 OK 9 11 2009 01 43 PM 86 OK 9 11 2009 01 43 PM 85 OK 9 11 2009 01 43 PM 84 OK 9 11 2009 01 42 PM 83 OK 9 11 2009 01 41 PM 82 OK 9 11 2009 01 41 PM 81 OK 9 11 2009 01 39 PM 80 OK 9 9 9nNG na n2 AM 79 OK NreeereNWNvN NM FM WHY FP WO KY DW E REGIE Rites les Sta HbuEs Each result
130. the Patient results log to see the results To transfer the results to a data analysis program see section Exporting data logs in chapter 2 Disc functions setup programs in the ABL9O FLEX Reference manual NOTICE Once the first measurement in this mode has been done the mode is available for the next 7 days In the 14 day period that follows the Calibration Verification mode is not available as measuring mode 6 9 6 Calibration ABL90 FLEX operator s manual 6 10 7 Replacements Screens during replacements 000cccccccccccccccnnnnnnnnnn cnc nn 7 2 Replacements creo rai ia aio 7 3 A A A 7 4 Sensor Cassette it o clica cet ites 7 5 PARTE Papers 7 9 PS deena ec O AA 7 10 Cleaning theanalyze aora 7 16 7 1 7 Replacements ABL90 FLEX operator s manual Screens during replacements The screens during replacements have an animation on the left side of the screen and the activities operator actions on the right side of the screen General remarks An arrow indicates a procedure in progress The triangle with an exclamation mark indicates a precaution where operator action should be taken 7 2 ABL90 FLEX operator s manual Replacements Viewing replacement A salirane status 2 EA Salic E contral ma e Renlacemente 7 Replacements Replace 12 24 Replace 12 24 NS d Stree Activities 340 Tests 240 I activites LS Grete n escages pale Stats Step Acti
131. this chapter 5 Quality management ABL90 FLEX operator s manual Unknown solutions Temperature corrections Reference Recalling quality control identification 5 12 Quality control on a solution identified as unknown are not compared with any previous measurements or statistics and therefore do not receive any status marking The parameter results for unknown levels cannot be plotted and are not included in any statistical data unless later changed to a defined slot For QC solutions from Radiometer temperature corrections are made automatically with the typed in temperature For non Radiometer QC solutions temperature corrections must be made manually Refer to the manufacturer s literature for procedure For a detailed explanation of the evaluation of results refer to Appendix Quality control in the ABL9O FLEX reference manual If the results are outside the acceptable control ranges please refer to Chapter 10 Analyzer messages in the ABL9O FLEX reference manual or follow the instructions on the Troubleshooting screen To change data that can be edited non gray lettered on the screen press QC ID NOTICES e If leaving the Quality control identification screen without entering a temperature the previous temperature will be recalled e Changing the temperature will initiate recalculation of the last result It will be substituted by the recalculated result and the statistics will also be recalculated In
132. tion pack by pressing the latch on the rear of the analyzer See Rear in section Hardware chapter 2 What is What Sensor cassette Replacing sensor cassette From the factory the sensor cassette comes dry stored in the sensor cassette pack to ensure a long shelf life Therefore a conditioning process where rinse solution is released to the sensors must occur before the sensor cassette can be used for measurements When conditioning the sensor cassette in the analyzer it typically takes 2 4 hours including a calibration for the sensor cassette to be ready for measurement If the conditioning by the analyzer is interrupted by the user by pressing Exit conditioning some of the parameters may subsequently have a in front of them Step Action 1 Press Menu gt Analyzer status gt Replacements gt Replace gt Replace sensors 2 Register the sensor cassette e by scanning the barcode of the sensor cassette pack see Barcode reader in section Hardware chapter 2 What is what e by entering the barcode manually by pressing the keyboard button and entering the missing numbers of the barcode of the sensor cassette Confirm with Enter and press Continue If no barcode is available press No Barcode in the Registration field Thereafter press the p button The sensor cassette compartment opens 7 5 7 Replacements 7 6 ABL90 FLEX operator s manual Remove the old sensor cassette by A a pulling it upwar
133. tor s manual 13 Specifications Input parameters List of The following input parameters are available independent of analyzer parameters configuration unit input range 15 0450 37 QUALICHECK5 ampoule 18 0 32 0 25 temperature T Fraction of oxygen in dry inspired air 0 0 100 0 FO2 1 fraction 0 000 1 000 Total hemoglobin concentration if not measured ctHb Parameter Respiratory quotient RQ Oxygen tension in mixed venous blood pO2 v kPa Oxygen saturation in mixed venous 0 0 100 0 blood sO2 v fraction 0 000 1 000 i 7 a x mL min Total oxygen consumption VO mmol 0 0 xxx x min Volume of carbon monoxide VCO The fraction of COHb measured 0 0 100 0 before the CO injection FCOHb 1 fraction 0 000 1 000 The fraction of COHb measured after 0 0 100 0 the CO injection FCOHb 2 fraction 0 000 1 000 numerical format Derived All parameters are calculated in SI units If other units are selected the results parameters are obtained by converting the SI units into those selected For detailed information see the ABL9O FLEX reference manual chapter 8 Parameters 13 3 13 Specifications ABL90 FLEX operator s manual Sample handling MA Measuring Cycle time Samples per 13 4 35 Capillary C65 65 uL 35 From the moment the inlet flap is lifted until the results are displayed May vary during startup ABL90 FLEX operator s manual 13 Specification
134. trend 7 e Press View filter to view the filter criteria the criteria cannot be changed only viewed e Press Print to print the displayed trend e Press Back to return to the Quality control log screen Viewing quality The screen is divided to show statistics for built in QC and ampoule based QC control solutions each identified by slot type and lot number for a single parameter eran oes Only those measurement values that fall within the statistical range are included in the statistical data Parameters outside the range of indication or with a are not included ay toe 3 0 005 0 159 59040 0 006 0 047 6 779 6 819 59050 0 023 0 155 FAT 7511 0 046 0 341 4 6809 0 046 0 000 0 001 3 7 587 0 000 0 000 0 000 5 7377 0 000 2 3 4 5 6 7 8 9 10 MENE Prey Cl Woe A y pH pH eor Ainin esve ar C rigi palar Arena Built in QC includes Lot to date and Bias to date statistics Ampoule based QC includes Month to date and Lot to date statistics The statistics give the following information 9 12 ABL90 FLEX operator s manual 9 Data management Number of measurements included in the statistics for the slot Mean Calculated mean of the measurement values 2 SD Calculated 2 x standard deviation of measurement values V Coefficient of variation Control range Current control range for the QC solution level See Appendix Quality control in the ABL9O FLEX reference manual for details
135. uble When the Troubleshooting needed screen appears follow the instructions on the shooting needed screen screen l The analyzer guides you through each troubleshooting procedure After each procedure the analyzer checks to see if the problem has been solved If the troubleshooting procedures do not solve the problem the analyzer enters the Operator intervention required screen To replace the 1 Log on I nlet Gasket 2 Tap Menu gt Analyzer status gt Consumables gt Replace gt Replace the inlet Holder gasket 3 Follow the instructions on the screen To see details 1 Log on about the Inlet Gasket Holder N Tap Menu gt Analyzer Status gt Consumables gt Status gt Gasket status Standardizing These terms have been changed in the software the terminology of the software Changed to Replace solutions Replace Solution pack The terms will be added to the manual the next time the manual is updated The contents of this document will be added to the manual the next time the manual is updated RADIOMETER Q Operator s manual Note to the users of the ABL90 FLEX analyzer Introduction From software version 2 6 2132 11 a clot detection and removal process has been added Instructions to Please put this document in the binder of your manual user Clot detection For preventive action the analyzer checks for clots during blood sample measurements and removal and once a day also during the system check
136. ume Please consult your local distributor for specific recommendations or chapter 14 Ordering information A CAUTION Risk of bias on pO results In general results obtained from capillary samples particularly pO values should be interpreted with caution as pO results may be biased due to aerobic sampling technique Alternatively draw an arterial blood sample ABL90 FLEX operator s manual 12 Sampling Procedures For information on the use and handling of sampling devices follow local procedures and manufacturers recommendations as well as the general recommendations given in section Causes of error in the preanalytical phase later in this chapter Special Besides adhering to the preanalytical issues addressed in section Causes of error considerations in the preanalytical phase and to local procedures also note the following about for capillary capillary specimens specimens E A l P e When performing capillary blood sample measurements use the mixing wire to ensure appropriate mixing of the sample with heparin coated on the inside of Radiometer capillary tubes and thereby prevent clots from being introduced into the analyzer The sample should be mixed immediately after collection as well as immediately before analysis Adult samples e Gently move a magnet back and forth along the length of the tube 10 times each way Allow the mixing wire to move all the way from end to end with every single stroke with the magnet Th
137. uter checks e Software checks e Mechanical checks e Electronical checks e Temperature checks e Consumable integrity checks on time of installation The system checks are performed at different times and with different intervals depending on the checks that are to be performed Some checks are performed once a day some with every rinse and others every 10 seconds For further information on the individual checks please refer to section Quality management in chapter 5 Sensors and measuring technologies in the ABL9O FLEX reference manual 5 7 5 Quality management ABL90 FLEX operator s manual Analysis check Description 5 8 During analysis be it a patient sample analysis a calibration or a QC measurement the analyzer performs different checks automatically to verify that the analyzer is functioning properly before under and after measuring activities If the analysis checks fail they are in most cases retried and if possible remedied automatically by the analyzer If these analysis checks fail again the analyzer enters the user intervention required or user action needed mode This means that if any interventions actions are required automatically or by the user the User Intervention Required or the User Action Needed screen appears with instructions on what to do to in the particular case The analysis checks consist of the following checks e Status calibrations checks e Sample integrity checks e Temperatur
138. ype of sample being measured but inside the reportable range ABL90 FLEX operator s manual 4 Sample measurement e Parameter value is outside the reportable range The reportable range can be selected for all measured and derived parameters e The values of a parameter with these markings are blanked out and hence not shown in the result The markings will however be printed together with the result au Instead e A parameter cannot be calculated or exceeds the of the value numerical limit of the analyzer range of indication k next to the e Values with user defined correction factors value Critical limit Critical limit y ants y 3 y y no marking l 2 t 4 e High LOW i lt Reference range gt parameter l g i parameter value value lt lt Critical range _ gt Reportable range LEA MMMIIIIIIA lt 1Mg e of indication gt Recalling patient I D Blood gas values cCl 110 mmol L pH 7 412 pCO 41 5 mmHg Metabolite values pO 86 3 mmHg cGlu 8 0 mmol L cLac 0 6 mmol L Oximetry values ctHb 15 1 g dL sO 97 3 FO Hb 95 5 FCOHb 1 3 FHHb 2 7 FiMetHb 0 5 FHbF 61 Electrolyte values ck 3 6 mmol L cNat 142 mmol L cla 1 21 mmol L as PA calibration a Prine us To recall the Patient identification screen press ID For detailed information refer to the section

ABL90 FLEX operator`s manual

Contents

Download Pdf Manuals

Related Search

Related Contents