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RADIOMETER FLEX ABL90, Reference Manual

The RADIOMETER FLEX ABL90 Reference Manual is an essential resource for understanding the functionalities and operation of this advanced medical device. It is available for free download from our website, providing users with comprehensive instructions and troubleshooting guidance. Unlock the full potential of your ABL90 by accessing the manual now.

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ABL90 FLEX reference manual 

7. Performance characteristics

  

  

7-29 

 

 

1.  Kristensen HB, Salomon A, Kokholm G. International pH scales and certification of pH.  

2.  Definition of pH scales, standard reference values, measurement of pH and related 

terminology (Recommendations 1994). Pure and Appl Chem 1985; 57, 3: 531-42. 

3.  Burnett RW, Covington AK, Maas AHJ, Müller-Plathe O et al. J Clin Chem Clin Biochem 1989; 

27: 403-08. 

4.  IFCC reference methods and materials for measurement pH, gases and electrolytes in blood. 

Scand J Clin Lab Invest 1993; 53, Suppl 214: 84-94. 

5. Glucose. 

CLSI/NCCLS 

Publication RS1-A. Clinical and Laboratory Standards Institute, 940 West 

Valley Road, Suite 1400, Wayne, PA 1908

7

, 1989. 

6.  Reference and selected procedures for the quantitative determination of hemoglobin in blood. 

Approved Standard (3rd edition), CLSI/NCCLS Publication H15-2A. Clinical and Laboratory 
Standards Institute, 940 West Valley Road, Suite 1400, Wayne, PA 19087, 2000. 

7.  Evelyn K, Malloy H. Microdetermination of oxyhemoglobin, methemoglobin and sulfhemoglobin 

in a single sample of blood. Biological Chem 1938; 126: 655-62. 

8.  Begmeyer. Methods of enzymatic analysis. 3rd ed., Verlag Chemie Deerfield Beach 1984; 6: 

582-88. 

9.  VIM93: ISO, International Vocabulary of Basic and General Terms in Metrology, Geneva: 

International Organization for Standardization; 1993. 

10.  Kristensen H.B. Traceability to the primary reference standards at Radiometer. Copenhagen: 

Radiometer Medical ApS, 2004. Code 918-541. 

11.  CLSI Evaluation of Precision Performance of Clinical Chemistry Devices; Approved Guidelines, 

EP5-A, Vol. 19, No. 2. 

12.  CLSI Protocols for Determination of Limits of Detection and Limits of Quantitation; Approved 

Guidelines, EP17-A, Vol. 24, No. 34. 

13.  CLSI Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline – 

Second Edition, EP9-A2, Vol. 22, No. 17. 

14.  CLSI approved guideline for interference testing in clinical chemistry, EP7-A, Vol. 22, No. 27. 

15.  Tan GB, Aw TC, Dunstan RA & Lee SH, Evaluation of high performance liquid chromatography 

for routine estimation of haemoglobins A2 and F. Journal of Clinical Pathology 46: 852-856.” 

16.  Fraser CG. The application of theoretical goals based on biological variation data in proficiency 

testing. Arch Pathol Lab Med 1988; 112: 402-15. 

17.  Ehrmeyer SS, Laessig RH, Leinweber JE, Oryall JJ. 1990 Medicare/CLIA final rules for 

proficiency testing: minimum intralaboratory performance characteristics (CV and bias) 
needed to pass. Clin Chem 1990; 36, 10: 1736-40. 

18.  Fraser CG, Petersen PH, Ricos C, Haeckel R. Proposed quality specifications for the imprecision 

and inaccuracy of analytical systems for clinical chemistry. Eur J CLin Chem Clin Biochem 
1992; 30: 311-17. 

19.  Westgard JO, Seehafer JJ, Barry PL. Allowable imprecision for laboratory test based on clinical 

and analytical test outcome criteria. Clin Chem 1994; 40, 10: 1909-14. 

20.  Vanderline RE, Goodwine J, Koch D, Scheer D, Steindel S, Cembrowski G. Guidelines for 

providing quality stat laboratory services. 1987 Laboratory Quality Assurance Commitee. 

21.  Wahlefeld AW, Herz G, Bernt E. Modification of the Malloy-Evelyn method for a simple, reliable 

determination of total bilirubin in serum. Scand J Clin Lab Invest 1972;29 Supplement 126: 
Abstract 11:12. 

List of 

references 

Summary of Contents for FLEX ABL90

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Page 5: ...c are sensitivity calibrated every four hour and status calibrated with every measurement CHAPTER 5 Calibration Sensitivity Definition In the table with the sensitivity range limits the pO2 max value has been changed from 105 to 110 The sensitivities are range checked pH pCO2 pO2 cK cNa cCa 2 cCl cGlu cLac pA mmol L pA mmol L Min 85 60 85 85 85 85 75 100 100 Max 105 105 110 105 105 105 105 2000 20...

Page 6: ...nalyzer message has been included No Message Interpretation Operator action 1340 Sensor cassette maintenance by Analyzer has been interrupted This message is used in the Activity log to indicate startup using a sensor cassette which has been left without an FTC activity for more than 1 hour No action required TABLE OF CONTENTS INDEX Conditioning in sensor cassette pack not possible As the pack wit...

Page 7: ...ors and measuring technologies 6 User defined corrections 7 Performance characteristics 8 Parameters 9 Solutions 10 Analyzer messages I Appendix Quality control II Appendix Traceability to primary standards at Radiometer Index Date of issue ABL90 FLEX Reference manual From software version 2 3 ...

Page 8: ...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 insta...

Page 9: ...ence and critical limits for each parameter 1 14 Reportable ranges 1 15 Patient report setup 1 16 Program 1 16 Creating a layout 1 16 Editing a layout 1 17 Patient ID layout 1 17 Default values 1 18 Editing patient result layout 1 19 Sample pre registration setup 1 20 Sample age evaluation setup 1 21 Calibration schedule setup 1 22 Program 1 22 Editing the settings 1 22 Available calibration sched...

Page 10: ...rogram 1 52 RADIANCE connection setup 1 52 LIS HIS connection setup 1 53 Automatic data transmission setup 1 55 Automatic data request setup 1 57 Patient lookup setup 1 58 QA Portal connection setup 1 59 Disk functions setup 1 60 Program 1 60 Automatic archiving setup 1 60 Automatic backup setup 1 62 Printers 1 63 Program 1 63 Printer setup 1 63 Automatic printing 1 64 Corrective actions 1 65 Prog...

Page 11: ...arcode reader 1 83 Sample counter 1 84 Purpose 1 84 Description 1 84 2 Disk functions setup programs 2 1 General information 2 2 Disk functions programs 2 2 Definitions 2 2 Data storage options 2 2 Disk handling rules 2 2 Creating a WDC report 2 3 Purpose 2 3 Backing up all data 2 4 Purpose 2 4 Restoring all data 2 6 Purpose 2 6 Exporting data logs 2 7 Purpose 2 7 Importing exporting archives 2 8 ...

Page 12: ...and components 4 3 Power supply 4 3 Sensor Module 4 3 Inlet positioning 4 3 User Interface Module 4 3 Printer unit 4 4 Sample mixer for safePICO only 4 4 5 Sensors and measuring technologies 5 1 Overview 5 2 General construction 5 2 Sensors 5 2 General measuring principles 5 3 Introduction 5 3 Activity vs concentration 5 3 Conversion of activity to concentration 5 3 Calibration 5 4 General informa...

Page 13: ...arts and description 5 18 Electrode chain potential 5 18 Unknown potential 5 19 Ion sensitive membrane 5 19 Nernst equation 5 19 Activity and concentration 5 19 Calibration of the pH and electrolyte sensors 5 20 Introduction 5 20 2 point calibration 5 20 Calibration levels 5 20 Calibration 5 20 Measurement pH and electrolytes 5 21 Measurement 5 21 Checks 5 21 pCO2 sensor 5 22 Construction of the p...

Page 14: ...suring process 5 37 ctHb and derivates 5 38 General information 5 39 Measured parameters 5 39 Construction 5 39 Measurement cycle 5 40 Lambert Beer s law 5 40 Absorbance 5 41 Total absorbance 5 41 Continuous spectrum 5 41 Spectrum examples 5 42 Determining concentrations 5 42 Matrix of constants 5 43 Calibration of the optical system 5 44 Calibration materials 5 44 Zero point 5 44 Cuvette path len...

Page 15: ...ls 7 5 Repeatability Reproducibility 7 5 Total analytical error 7 5 Test conditions 7 6 Performance test results chart description 7 7 Modes 7 7 Number of measurements 7 7 Performance test results pH 7 8 Reference method 7 8 BiasPrim ref 7 8 BiasSec ref and Repeatability blood samples 7 8 Performance test results pCO2 7 8 Reference method 7 8 BiasPrim ref and Repeatability blood samples 7 8 Perfor...

Page 16: ...iasSec ref and Repeatability blood samples 7 16 Performance test results FMetHb 7 16 Reference method 7 16 BiasPrim ref 7 16 BiasSec ref and Repeatability blood samples 7 16 Performance test results FHHb 7 17 Reference method 7 17 BiasSec ref and Repeatability blood samples 7 17 Performance test results FHbF 7 17 Reference method 7 17 BiasPrim ref and Repeatability blood samples 7 17 Performance t...

Page 17: ... FCOHb 1 8 14 FCOHb 2 8 14 Derived parameters 8 15 General information 8 15 Acid base derived parameters 8 15 Oximetry derived parameters 8 16 Oxygen derived parameters 8 16 Units and numerical format of derived parameters 8 19 Calculated versus estimated parameters 8 19 Electrolyte parameters 8 19 Possible ranges and precision number of decimals 8 20 List of equations 8 23 Units and symbols 8 23 ...

Page 18: ...ion Gap K 8 34 Anion Gap 8 34 cCa2 7 4 8 34 Eq 46 47 8 34 mOsm 8 34 FHbF 8 34 pO2 x T 8 35 VCO2 V dry air 8 36 VO2 V dry air 8 36 Oxyhemoglobin dissociation curve ODC 8 37 ODC equations 8 37 The ODC reference position 8 37 The ODC displacement 8 38 The actual ODC position 8 39 Determining the actual displacement 8 39 Coordinates on the ODC 8 41 Conversion of units 8 42 SI units 8 42 Temperature 8 ...

Page 19: ...itions I 4 User control ranges for manual QC only I 6 Introduction I 6 Establishing analyzer specific control ranges I 6 Table 1 I 7 Statistics factor and statistics range I 9 Definitions I 9 Example I 9 Temperature corrections for manual QC only I 10 Purpose I 10 Parameters that require temperature correction I 10 Temperature corrections for pH pCO2 and pO2 I 11 Westgard rules I 12 About Westgard...

Page 20: ...ABL90 FLEX reference manual cLac II 4 ctHb II 4 Saturation sO2 100 II 5 Saturation sO2 0 II 5 FCOHb normal value II 5 FCOHb 100 II 5 FMetHb II 5 FHbF II 5 Hct II 5 ctBil II 6 References II 7 Index Date of issue ...

Page 21: ...6 QC input setup 1 28 QC statistics 1 29 Westgard Rules setup 1 30 RiLiBÄK ranges 1 32 Replacement setup 1 35 Replacement schedule setup 1 35 User activities 1 37 Maintenance planning 1 39 Replacement warnings 1 40 Parameters and input setup 1 41 Parameter setup 1 41 Units setup 1 43 User defined patient data items 1 44 User defined notes 1 46 Analyzer settings 1 47 Analyzer identification 1 47 Ti...

Page 22: ...tup 1 59 Disk functions setup 1 60 Automatic archiving setup 1 60 Automatic backup setup 1 62 Printers 1 63 Printer setup 1 63 Automatic printing 1 64 Corrective actions 1 65 Miscellaneous setup 1 67 Setup default settings 1 70 Print setup 1 78 Contents of setup settings 1 79 Interfacing facilities 1 82 Sample counter 1 84 ...

Page 23: ...atistics Westgard Rules RiLiBÄK ranges Print analyzer setup Disk functions setup Automatic archiving Automatic backup General setup Parameters and input Parameters Units User defined data items User defined notes Communications RADIANCE connection LIS HIS connection Automatic data transmission Automatic data request Patient lookup setup QA Portal connection Analyzer settings Analyzer ID Time Date ...

Page 24: ...le centralized User Management With this option enabled you can only view the operators not add edit or remove any of them All users defined on the ABL90 FLEX analyzer are deleted and the list of users in the RADIANCE system is copied to the ABL90 FLEX analyzer NOTICE This option can only be enabled if RADIANCE communication is enabled in the RADIANCE Connection Setup program To define how the use...

Page 25: ...ty screen This program allows you to add edit or remove operators and to assign an access profile to each operator NOTICE If the Centralized User Management option is enabled in the General Security screen you cannot add remove or edit the operators but only view the access profiles of the individual operators To enter the Operators and Passwords program press Menu Utilities Setup Analyzer Securit...

Page 26: ...than 32 4 Re enter or re scan the password in the Confirm box 5 Enter or scan the logon barcode in the Logon barcode box The password must be at least four characters long The logon barcode and the password can be identical 6 Re enter or re scan the logon barcode in the Confirm box 7 Press Back If the password is not accepted the Add New Operator screen remains open and a message telling you what ...

Page 27: ...he password is not accepted the Add New Operator screen remains open and a message telling you what was wrong appears If the password is accepted the Operators and Passwords screen is displayed 4 In the Operators and Passwords screen select the desired access profile of the new operator To remove an operator from the list use the up down arrow buttons in the Operator box to highlight the operator ...

Page 28: ...press the check buttons once again To define the available menu items and button shortcuts of an access profile do the following Step Action 1 In the Access Profiles screen highlight the desired access profile in the Profile names box and press Menus and Buttons Note that this button is grayed out for the service technician profile 2 Select the desired menu items in the Menu Items in Quick Menu bo...

Page 29: ...ick Menu box and then in the Button configuration box press the button position that you wish to give the selected item 4 Select other five buttons in the same manner if desired 5 To deselect a button press it once again 6 Press Back to return to the Access Profiles screen Enabling the My Results option will give the operator an easy access to all Patient Results made by that operator by displayin...

Page 30: ...tton to enter a program The following programs are available Syringe mode Capillary mode Patient reports Reference ranges Sample age evaluation setup Reportable ranges Sample pre registration Syringe capillary modes The Syringe modes setup screen is shown below The Capillary modes setup screen is shown below Program ...

Page 31: ... button in the Use dynamic parameters box to select parameters during a sample measurement A parameter is disabled i e excluded from the Parameter profile screen and the parameter bar in General setup Parameters and input A parameter that has been deselected for the given syringe or capillary mode will be measured but excluded from the displayed and printed patient report You can further select or...

Page 32: ...r all measured and calculated parameters For each parameter you can choose whether or not to differentiate between the categories of sample type sex and age group Step Action 1 Highlight a parameter in the Parameter box using the up down arrows 2 Press the check button in the Sample type box and select a sample type using the up down arrows in the box NOTICE Press the check button to activate a fu...

Page 33: ...h a white cross Up down arrows to scroll through the list of possible age limits As the list is scrolled the text on the age group bar changes accordingly 3 Repeat step 2 for each limit to be changed 4 Press Back when completed to return to the Reference ranges and critical limits screen 5 Activate the Age group check button in the Reference ranges and critical limits screen and select the desired...

Page 34: ...t and you cannot use any of them press Clear limits Then enter new critical and reference limits using the keypad and confirming each entry with Enter 5 To change a value touch and highlight it Then enter the limit and confirm with Enter 6 Press Back to return to the Reference ranges and critical limits screen 7 Highlight a parameter in the Parameter list box to view the limits on the Reference ra...

Page 35: ...parameter and press Set default 5 To change all parameters to the default values press Set all default Press Continue to change the reportable ranges of all parameters to the default ones Press Cancel to keep the user defined reportable ranges and return to the previous screen 6 Press Close to exit and confirm the selected settings NOTICES A reportable range must be smaller than or equal to the ra...

Page 36: ...s on the highlighted layout by pressing R default This will give you a starting point for designing your own layout 4 Edit your layout as described in Editing a layout further in this section 5 If desired make the highlighted layout a default for your analyzer by pressing Make default It will be marked with in the list of layouts 6 Make a test printout if desired of the highlighted layout patient ...

Page 37: ...ms by pressing the button Or Remove a highlighted item from the Selected items box by pressing the button 2 Press Set as mandatory to make a highlighted item in the list of selected items mandatory The item will be indicated by a on the Patient ID screen and must be entered during a measurement before a patient result can be viewed 3 To remove the mandatory mark highlight the item in the Selected ...

Page 38: ...rm If the item has a list of options press List highlight the option using the arrow buttons and press Enter to confirm 3 Set or change other default values in a similar manner NOTICE It is not possible to set default values for all items The values can be changed on a result by result basis on the Patient identification screen An item placed in the Selected items list does not appear in the Avail...

Page 39: ...t highlight it and press 4 Select another parameter group along with parameters for this group in the same manner 5 Use layout commands New group items following this command are placed at the top of the next half of the screen New Line a line is inserted between items New Page items following this command appear on next screen page as desired and press To show the range of a selected item do the ...

Page 40: ...tep Action 1 Use the up down arrow buttons to select the interpretation of the barcode setting in the Interpret barcode input as box Choose one of the following Patient ID Accession Number Sampler ID Note that choosing the Accession Number or Sampler ID will gray out its check button Sampler ID on the screen above 2 Select the barcode entry 3 Activate the relevant check buttons in the Included fie...

Page 41: ...ess the check button in the Enable sample age evaluation box 2 Select the maximum sample age in minutes for pH using the arrow buttons 3 To enable the same number of minutes for all parameters press the check button next to Same rule for all the parameters 4 Press Close to return to the main screen To edit the maximum sample age do the following Step Action 1 In the Parameter Aging timetable selec...

Page 42: ...ration schedule and in this way minimize the number of activities and ensure the most optimum utilization of the solution pack When the QC schedule is linked to the calibration schedule the built in QC will by default run at the following times 04 00 12 00 and 20 00 04 am 12 midday 8 pm If however calibration is set to start at a different time than 00 00 e g 00 30 the built in QC will run corresp...

Page 43: ...lution to a specific slot manual QC measurements only Built in QC results are assigned to the slots A B and C Step Action 1 Highlight a slot using the arrow buttons 2 Solutions from Radiometer the QUALICHECK5 control solution scan the barcode or press Keyboard to enter the barcode information see Barcode reader in section Hardware chapter 2 What is what in the ABL90 FLEX operator s manual Non Radi...

Page 44: ...reate a WDC Report disk see chapter 2 Disk functions setup programs Quality control schedule setup In this program you schedule QC measurements both built in and manual for your analyzer for all days of the week Navigation and Use to select time during a day and Use to display other weekdays Symbols for manual and built in QC Measurement s on the manual QC Measurement s on the built in QC performe...

Page 45: ...to select the days of the week on which this measurement should be performed 4 Highlight the Start time box using Field up and key in the time to perform a measurement and confirm with Enter on the keypad 5 Highlight the Repeat box and select the interval with which the measurement should be repeated using the up down arrows in the box The QC schedule reminder Lock analyzer when QC overdue selecte...

Page 46: ...g the Quality control schedule setup screen By default the analyzer is set up to run Built in QCs after replacement and startup To deactivate this function deactivate the check button next to the Run Built in QCs after replacement and startup QC ranges In this program you can do the following Globally update all control ranges of a slot to a calculated lot to date range Individually edit parameter...

Page 47: ... Fixed SD To change the SD value touch the SD field to highlight it and enter the value using the keypad Confirm the entry with Enter 5 Highlight the limit by touching it on the screen and enter your own value s using the keypad Confirm with Enter 6 Repeat the procedure for other parameters in the same manner NOTICES See I Appendix Quality control in this manual for detailed information on statist...

Page 48: ...Cancel to cancel updating NOTICE Once the Fixed SD has been activated you cannot update the control ranges to limits that are narrower than those determined by the Fixed SD for both single parameter and multiple parameter updates QC input setup In this program you can select the following for the Quality control identification screen during a manual QC measurement Mandatory temperature entry by th...

Page 49: ...nt The temperature can be changed for a particular measurement but will return to the default setting for future measurements QC statistics In this program you can select the following The statistics factor Automatic printing of QC statistics when the lot changes Step Action 1 Key in the desired statistics factor from 1 0 to 9 9 on the keypad and confirm with Enter The default value is 1 5 2 Activ...

Page 50: ...ivate the assigned Westgard Rules for the slot or press this button again to deactivate them NOTICE The Westgard Rules are a set of statistical rules When applied to the QC results they can increase the probability of detecting an error in the sampling procedure or in the analyzer itself or they can help detect a shift or trend in your QC results by comparing current measurement values of a QC sol...

Page 51: ...Activate the desired Westgard Rule s by pressing the corresponding check button All future quality control data for the given slot parameter will be evaluated according to the selected Westgard Rule s 4 Select Westgard Rules for other parameters or levels in the same manner 5 Press Back to return to the Westgard Rules setup screen Selecting deselecting all Westgard Rules Step Action 1 Display the ...

Page 52: ...is manual Use On Off to restore the previous settings Westgard JO Barry PLL Cost effective quality control managing the quality and productivity of analytical processes Washington AACC Press 1992 RiLiBÄK ranges The RiLiBÄK ranges program allows you to define a set of rules to control the maximum deviation of any parameter from the assigned target value The assigned target values are given on the Q...

Page 53: ...until the first Lower Limit box is highlighted and enter the desired lower limit 4 Highlight the next box and select or 5 Highlight the first Upper Limit box and select or 6 Highlight the next Upper Limit box and enter the desired lower limit 7 To select the desired range press the desired radio button 8 Enter the desired range in the Ranges box 9 Press Back to return to the RiLiBÄK ranges screen ...

Page 54: ...een below 2 Use or to jump between the input boxes and edit the desired values 3 Press Back to return to the RiLiBÄK ranges screen To remove a RiliBÄK rule do the following Step Action 1 Highlight the desired rule in the RiLiBÄK ranges screen and press Delete NOTICE When a QC measurement violates an applied RiLiBÄK rule a red R is shown in front of the parameter name in the result ...

Page 55: ... a program The following programs are available Replacement schedule User activities Maintenance planning Replacement warning Replacement schedule setup In this program you can schedule routine replacements along with the current scheduled date and interval for replacement The settings selected here are then used in Replacement on the Analyzer status screen Program ...

Page 56: ...n 5 Repeat steps 1 4 for each replacement action to be scheduled Action Interval Replacing solution pack When the number of available activities has reached zero or after max 30 days in the instrument Replacing sensor cassette When the number of available tests has reached zero or after max 30 days in the instrument Replacing inlet gasket Every 3 months NOTICE The replacement intervals are guideli...

Page 57: ...d in the Replacement status Step Action 1 Press Add to display the Edit user activities schedule screen 2 Press the Keyboard button and type a new activity Confirm with the Enter button on the keyboard 3 Select the interval using the up down arrows in the Interval box 4 Type in the Next date using the screen keypad Confirm with Enter 5 Press Back to return to the User activities screen and repeat ...

Page 58: ...ange if desired the interval or next date confirm the date with Enter 3 Press Back to return to the User activities screen and edit other user activities in the same manner Step Action 1 On the User activities screen highlight the action to be deleted and press Delete 2 Press Continue to delete the activity or press Cancel to return to the User activities screen Editing a user activity Deleting a ...

Page 59: ...gram you can plan replacements during a week and the shift Step Action 1 Activate the check buttons for the days on which maintenance is to be performed 2 Select the time at the beginning or the end of the shift using the up down arrows 3 Press Close to confirm the settings ...

Page 60: ...will affect the status of the traffic light on the main screen Step Action 1 Select the number of remaining tests before the warning should be given using the up down arrows 2 Select the time before a replacement warning using the up down arrows 3 Select the expected measurements per day using the up down arrows 4 Press Close to confirm the settings ...

Page 61: ... you can do the following Disable or enable a parameter Repress parameters if problems are detected Lock a parameter Make user defined corrections for each measured parameter Make out of range suppression of oximetry parameters and bilirubin Disabling enabling a parameter Step Action 1 Highlight a parameter on the screen using the scroll facilities 2 Press Enable Disable to include exclude the par...

Page 62: ...ut if the analyzer is connected to the RADIANCE system 4 To unlock a parameter highlight it and press Lock Unlock The traffic light on Analyzer status will change from YELLOW to a color corresponding to the analyzer s overall status NOTICE A locked parameter will show YELLOW on the parameter bar and will change the overall analyzer status traffic light on the Analyzer status screen to YELLOW The p...

Page 63: ...lues exclusive ctHb inside the range of indication but lower than 0 or higher than 100 will be shown as 0 or 100 respectively o ctBil values lower than 0 µmol L but inside the range of indication will be shown as 0 µmol L 3 Enter correction offset and correction slope Confirm each entry with Enter 4 Press Back to return to the Parameter setup screen and repeat steps 1 3 for another parameter if de...

Page 64: ...irm with Select 3 Change units for other parameters in a similar manner 4 Press Close to return to the main screen User defined patient data items In this program you can include other patient data in the Patient ID layout than those already available there Editing an item in the list Step Action 1 Highlight an item on the User defined patient data items screen and press Edit ...

Page 65: ...rm with Enter on the keypad 7 Min value is now highlighted Type in the value and confirm with Enter on the keypad 8 Press the check button to activate the Use selection list function To make a list Press Add Type in the item on the displayed keyboard up to 20 characters Confirm with Enter Add as many items as you wish in the same manner 9 Press Back to return to the User defined patient data items...

Page 66: ...xt for the Note using the screen keyboard Confirm with Enter to save the text and return to the previous screen Editing a Note Step Action 1 Highlight a Note in the Notes box using the up down arrows and press Edit 2 Edit the text and confirm with Enter Deleting a Note Step Action 1 Highlight a Note in the Notes box 2 Press Delete NOTICE A list of Notes made for a given option will be marked with ...

Page 67: ... Language Analyzer identification In this program you can change the analyzer s identification Step Action 1 Touch and highlight the Analyzer name box if not already highlighted 2 Type in an identification name and or number for the analyzer up to 32 characters using the screen keypad or keyboard Confirm with Enter NOTICE The installation number cannot be changed Quote this number in any technical...

Page 68: ... time and date setting Step Action 1 Highlight the Time box by touching it on the screen 2 Key in the time on the screen keypad Confirm with Enter Separators are automatically added between hours minutes and seconds 3 Repeat steps 1 2 to set the date 4 To revert to the previous settings press Current ...

Page 69: ... volume for the acoustic signal or activate the Mute all acoustic signals check button Available event Explanation Value exceeds critical range One of the measured values exceeds the specified critical limits for that parameter Close inlet The inlet should be closed Result is ready A sample has been analyzed and the results are ready for viewing Inlet is open too long The inlet should be closed ...

Page 70: ... Action 1 Key in the desired pressure value on the keypad 2 Confirm with Enter The value will be shown in the Measured adjusted box Maximum accepted correction is 19 mmHg i e the difference between the Measured unadjusted and Measured adjusted settings Barometer pressure limits are 450 800 mmHg or 60 0 106 7 kPa or 450 800 Torr The units are selected in the Setup program Units ...

Page 71: ...nstalled Not all listed languages may be available Step Action 1 In the Select a language from the list box select the desired language with the arrows and press Set language To choose a special regional setting e g English US select the desired regional setting in the Regional language box and press Set regional settings 2 Press Continue to restart the analyzer Press Cancel to continue operating ...

Page 72: ...cation of the serial RS 232 interface connection COM and the network TCP IP RJ45 Ethernet connection RADIANCE connection setup In this program you can connect the analyzer to the RADIANCE system NOTICE Connecting the analyzer to the RADIANCE system should be performed by the RADIANCE administrator of your institution Step Action 1 Touch and highlight the Server address box Type in the TCP IP addre...

Page 73: ...shed connection to the RADIANCE system A RADIANCE icon in the Information bar will indicate the established connection as well 7 Clear the queue by activating the recycle bin icon The Output queue box shows the number of data queued up for transfer It will be sent to the RADIANCE system 8 Press Close to exit LIS HIS connection setup In this program you can select the communication protocol for a c...

Page 74: ...tocol according to the requirements of the connected device using the up down arrows in the box Available protocols ASTM ASTM6xx HL7 ver 2 2 HL7 version 2 5 or POCTDML1A 4 Select the low level protocol as follows Use Serial or Serial RAW for the serial connection Use Network TCP IP for the network connection Use Network TCP IP ASTM for additional serial connection not all combinations of high leve...

Page 75: ... default is None 6 Connection specifications for network low level protocol Press Edit to display the Connection Specifications screen Touch the screen to highlight the following boxes one after another Server Address Com Port Reconnect interval Use the keypad keyboard to enter the relevant information 7 Connection specifications for POCTDML1A low level protocol Touch the screen to highlight the f...

Page 76: ...t check button s to select the data to be sent to the highlighted connection NOTICE If the requested patient data e g Patient Last Name was received after leaving the Patient identification screen the patient report will be transmitted without the data To prevent this select one of the patient data items transferred from LIS HIS as mandatory ...

Page 77: ...e From connection box using the up down arrows 2 Activate the relevant check button s to request patient demographics when entering Patient ID Accession number Sampler ID 3 Press Close when completed NOTICE If the requested patient data e g Patient Last Name was received after leaving the Patient identification screen the patient report will be stored without the data in the Patient report log The...

Page 78: ... which to obtain the patient information on the Patient identification screen Step Action 1 Select a data source from the established connections local database RADIANCE or LIS HIS connections 2 Select the number of days you want each patient to be kept in the list using the up down arrows in the box 3 Press Close ...

Page 79: ... QA Portal do the following Step Action 1 Touch and highlight the Server address box Type in the TCP IP address of your QA Portal using the screen keypad or keyboard 2 Touch and highlight the Port box Type in port number using the keypad 3 Press the check button in the QA Portal communication box to activate the connection The icon in the Connection status box indicates the state of the QA Portal ...

Page 80: ...eneral setup Disk functions setup and activate a button to enter a program The following programs are available Automatic archiving Automatic backup Automatic archiving setup In this program you can select automatic archiving of the data logs by activating the relevant check buttons Program ...

Page 81: ...ed the correct destination appears in the upper part of the box 4 Press Back to return to the Automatic archiving setup screen 5 Press Close to return to the main screen NOTICE The oldest records 500 patient reports QC or calibration results or 2000 entries in the Activity log will be automatically removed from a data log and placed in the relevant archive The archives can be stored on the analyze...

Page 82: ...nt backups in the Interval days box and type in the number of days using the screen keypad Confirm with Enter 4 Press the drive icon next to the Destination box to select destination 5 Highlight the drive or folder and press Expand Collapse to open a folder in a directory or within a folder Note that automatic backup can be selected for the internal disk or the network When completed the correct d...

Page 83: ...any number of printers but only up to 10 printers can be selected at a time 3 Activate the check button in the Manual printing box to display the list of printers every time the Print button has been pressed If not activated all selected printers will make a printout every time the Print button is pressed 4 Press Edit to display the keyboard to change the highlighted printer s name Type a name and...

Page 84: ...tivity log messages Step Action 1 Activate the desired check buttons for automatic printout 2 Select automatic printout of several copies 1 5 of patient results using the up down arrows in the Patient results print options box 3 Press User Manager or Service in the Message level box to select the level for the messages in the Activity log 4 Press Close to return to the main screen ...

Page 85: ...or GREEN if available for the specified event by pressing the traffic light in the Traffic light signal box see the table below 4 Select corrective actions traffic light signal for the other conditions in a similar way Conditions and corresponding corrective action options are as follows Condition Corrective action Traffic light Calibration error s present Do not run scheduled built in QC GREEN or...

Page 86: ...ignal and the messages will continue to appear until the condition no longer exists Corrective action Explanation on specific parameters The affected parameter s will be marked with in subsequent patient results Message on next patient result The subsequent patient results will be marked on the Message screen Lock analyzer when QC overdue If a scheduled quality control measurement is more than 0 o...

Page 87: ...xt box on the Patient profile Patient identification Patient result and Quality control identification screens where it is possible to enter a barcode Enable patient result approval Enables the additional buttons on the Patient Result screen used for approval of results For detailed information refer to chapter 4 Sample measurement in the ABL90 FLEX operator s manual Apply parameter corrections to...

Page 88: ...for HbF levels higher than 20 To select the desired option use the arrow buttons in the box Guidelines for selecting deselecting HbF correction For neonatal samples Use Enabled for all levels It is important to enable HbF correction to obtain correct results for ctBil sO2 FO2Hb FMetHb FCOHb and FHHb For adult samples Use Disabled or Enabled for levels 20 NOTICE When an adult sample is measured wit...

Page 89: ...0 characters long and confirm with Enter To delete the current message press Delete on the keyboard or delete a message and type a new one if desired 2 Confirm the change with Enter to return to the Miscellaneous setup screen Step Action 1 Check that the Enable screen saver check button is activated in the Setup box 2 In the Screen saver box select the time with the arrow buttons Analyzer messages...

Page 90: ...m 1 X Custom 2 X Custom 3 X Remote operator X X X X X X X X A Perform measurement B Perform calibration C Perform replacements D Perform Disk Functions E View Data Logs F Edit data in logs G Enter Setup Programs H Enter Service Programs I Approve results Columns D E G and H are controlled via the Menu and button configuration screen settings not via the check buttons on the Access profiles screen ...

Page 91: ...cluded fields All fields On Sample logistics setup Sample age On 30 minutes for all parameters Layouts R Default Patient ID layout settings included in the R Default layout Patient ID Patient last name Patient first name Sample type Temp C Patient result settings included in the R Default layout bold text a new title xxx xxx the reference range for a parameter Blood gas values pH xxx xxx pCO2 xxx ...

Page 92: ...Group Oxygen Status ctO2 p50 New Line Acid Base status cBase Ecf Patient reports continued 3 HCO P st c Activity Default setting tHb calibration 3 months Start time of first calibration 00 00 Link QC schedule to calibration schedule On Program Item Default setting Statistics factor 1 5 Cut off date for month to date statistics 1 Remind to print statistics each month No QC statistics Remind to expo...

Page 93: ...ngs Para meter Enabled Locked Repression Offset Slope Units Out of range suppression pH Not altered No 0 000 1 000 N A pCO2 Not altered No 0 0 1 000 mmHg N A pO2 Not altered No 0 0 1 000 mmHg N A ctHb Not altered No N A 1 000 g dL No sO2 Not altered No 0 0 1 000 No FO2Hb Not altered No N A N A No FCOHb Not altered No 0 0 N A No FMetHb Not altered No 0 0 N A No FHbF Not altered No 0 1 000 Yes FHHb ...

Page 94: ...ns FO2 I Hct pO2 a A FShunt RI cK cNa cCl mmol L cCa2 mmol L cGlu mmol L cLac mmol L Temperatures C ctO2 Vol ctCO2 Vol D O2 mL min V O2 mL min Age years Weight kg Height m Altitude m Birth weight g User defined patient data items default settings Name Type Unit Decimals Spontaneous RR Numerical b min 1 Set RR Numerical b min 1 Vt Numerical L 2 Ve Numerical L 2 ...

Page 95: ...one None User defined notes default settings No notes defined Language default setting English Acoustic signals default settings Event Default setting Value exceeds critical limits No Close inlet Yes Result is ready Yes Inlet is open too long Yes Corrective actions default settings Event Default setting Traffic light Calibration error s present Do not run QC YELLOW Calibration schedule reminder s ...

Page 96: ...ar On HbF correction Enabled for levels 20 Analyzer message Blank Screen saver 5 minutes to wait when idle Automatic printing default settings Item Default setting Patient results On QC results Off Calibration results Off Activity log message Off Message level User Number of copies 1 Printer setup default settings Item Default setting Installed printers Internal Printer added printers are not dele...

Page 97: ...em Off LIS HIS None Automatic data request When entering sampler ID on Automatic data transmission Patient results Calibration results QC results Activity log messages Patient lookup Local database Remote control Enable remote access The following setups have no Radiometer settings Barometer setup Time and date setup Analyzer identification setup Setups without Radiometer settings ...

Page 98: ...ur analyzer setup Step Action 1 Press Menu Utilities Setup Print analyzer setup 2 All check buttons are activated Deactivate relevant check buttons to deselect those setups that you do not wish to be printed out 3 Press Print to start printing the selected setups or press Close to return to the main screen ...

Page 99: ...saved Selecting or deselecting items in the setup see Loading restoring setup chapter 2 Disk functions setup programs Each setup group of settings is described in this section The following settings i e screens and their data will be restored in the Parameters group Item Setup screens Sample modes Syringe mode Capillary mode Parameter setup offset and slope only Parameter units Units setup Correct...

Page 100: ... locked Automatic printing Automatic archiving Automatic backup Save setup destination Load setup source Backup all data destination Export data logs destination Function External keyboard enabling Function Enable remote access when operator is logged on QC statistics setup QC input setup Westgard Rules enable Westgard Rules Printer setup show list of printers Layouts Patient report setup Patient ...

Page 101: ... schedule QC schedule is restored for the slots with the control solutions installed in them The schedule follows the slots not the QC levels Wet section setup Calibration schedule minus tHb Cal and the start time Westgard rules Westgard rules settings Replacement schedule Replacement schedule User activities schedule User activities Edit user activities Schedules etc ...

Page 102: ...uired for connection to the analyzer The keyboard layout must correspond to the language version used by the analyzer Connecting a keyboard Step Action 1 For an IBM enhanced personal computer keyboard only Shut down the analyzer 2 Connect the keyboard to the keyboard port at the rear of the analyzer 3 For an IBM enhanced personal computer keyboard only Turn on the analyzer After restart the keyboa...

Page 103: ...as been physically connected to the network one of two of the protocols stated below is used for communication with the central computer ASTM HL7 POCTDML1A For further information refer to the Communication protocol specifications for Radiometer products code no 989 329 Radiometer recommends that a qualified service technician carry out connection of the analyzer to a network An external barcode r...

Page 104: ...s last reset User column The following is registered Activity Number of Total Completed sample QC measurements calibrations only Interrupted or aborted activities are excluded Aborted Aborted sample QC measurements calibrations due to sample errors wet section errors etc interrupted activities excluded Counters User All completed sample QC measurements calibrations performed by all operators since...

Page 105: ...ons setup programs General information 2 2 Creating a WDC report 2 3 Backing up all data 2 4 Restoring all data 2 6 Exporting data logs 2 7 Importing exporting archives 2 8 Saving setup 2 9 Loading restoring setup 2 10 ...

Page 106: ...ata logs To export or delete archived data logs Save setup To save the current setup of your analyzer Load setup To load a previously saved setup Restore default setup To restore all or only some Radiometer default settings Setup data refers to information or files that configure the analyzer to operate according to settings defined in the Setup programs All data refers to data in the analyzer s i...

Page 107: ...and touching it on the screen Press Expand Collapse to open a folder in a directory or within a folder When completed the correct destination appears in the upper part of the box Press Back to return to the previous screen 3 In the File name box the WDC report screen press the Keyboard button to type the file name you can change the four characters WDC_ Confirm with Enter on the keyboard and retur...

Page 108: ...lly performed backup Data can be stored on a network a connected CD drive or a removable drive Automatic backup can be selected see Automatic backup setup in section Disk functions setup chapter 1 in this manual Data can be stored on the internal disk or the network In case of data loss or similar problem the loss can be minimized by using the backup file and the Restore All Data function NOTICE I...

Page 109: ...ive is used connect it to the USB port Press Back to return to the previous screen 3 On the Backup all data screen press Start to continue 4 The backup process begins Network drive or internal disk Backup continues without any further action from the operator Removable drive Wait for the data to be prepared see the timer in the current task field located next to the status indicator in the upper l...

Page 110: ... folder When completed the correct destination appears in the upper part of the box If a removable drive is used connect it to the USB port Press Back to return to the previous screen 3 On the Restore all data screen press Start to continue Or press Close to cancel and return to the main screen 4 The restore process begins Network Restoring does not require any further action Removable drive Press...

Page 111: ...nter Repeat the same for the To date Press Back to return to the Export data logs screen 3 Activate the Disk drive button on the Export data logs screen Activate the desired drive by touching it on the screen Press Expand Collapse to open a folder in a directory or within a folder When completed the correct destination appears in the upper part of the box Press Back to return to the Export data lo...

Page 112: ...essing the Disk drive button 3 Touch and highlight the desired location on the Source Destination screen Press Expand Collapse to open a folder in a directory or within a folder When completed the correct destination appears in the upper part of the box 4 Press Back to return to the Import Export archives screen 5 On the Import Export archives screen press Export Press Refresh to update the conten...

Page 113: ...Setup programs Step Action 1 Press Edit location to select destination 2 Select the required location by touching it on the screen If a removable drive is used connect it to the USB port Press Expand Collapse to open a folder in a directory or within a folder When completed the correct destination appears in the upper part of the box 3 Press Back to return to the Save setup screen 4 On the Save se...

Page 114: ...o include an item 3 To open or close a group of items highlight the group title e g General and press the button 4 Press the Change source button to select the source Removable disk Connect it to the USB port 5 Select the required source by touching and highlighting it on the screen 6 Press Expand Collapse to access the required folder The chosen source appears in the Choose a directory box 7 Pres...

Page 115: ...3 Wet section Introduction 3 2 Wet section diagram 3 3 Measuring processes 3 4 General information 3 4 Patient samples 3 5 Rinse process 3 6 Calibration 3 7 Automatic QC 3 8 Manual QC samples 3 9 ...

Page 116: ...essary with the ABL90 FLEX analyzer as gas is included in the solution pack The main components of the wet section are Inlet Sensor cassette Oximetry system Internal tubing Tube valve Peristaltic pump for solution and sample transport Liquid sensors Waste connector Solution pack containing three calibration solution pouches one of them being for rinse one gas mixture pouch three quality control so...

Page 117: ...Oximetry module 11 Waste pouch 2 Reference electrode 12 CAL 3 pouch 3 Sensor interface 13 CAL 1 pouch rinse 4 Optical pO2 14 Gas mixture pouch 5 Inlet 15 QC 1 solution pouch 6 Valve 16 CAL 2 pouch 7 Liquid sensor 3 17 QC 3 solution pouch 8 Liquid sensor 2 18 QC 2 solution pouch 9 Liquid sensor 1 19 Flow selector 10 Peristaltic pump 20 Pump tube 21 Waste connector Diagram ...

Page 118: ...rior to a measurement the sensor cassette contains CAL 1 from the solution pack The sensor cassette measurement chamber and the cuvette in the hemolyzer unit of the optical system is thermostatted to 37 C to ensure correct measuring conditions All necessary solutions contained in the solution pack are introduced automatically as required into the sensor cassette and oximetry module via the flow se...

Page 119: ...e solution 3 The sample is drawn into the sensor measuring chamber and the oximetry module This process is controlled by liquid sensors that also check sample homogeneity with respect to air bubbles A appears in case of an inhomogeneous sample In case of problems during the process or in case of insufficient sample the measuring process is aborted as the validity of the measuring result may be com...

Page 120: ...cess Stage Description 1 After the measurement is complete the first part of the rinse is performed with a mixture of solutions and air 2 The next part of the rinse is performed with a mixture of solutions and gas 3 Thereafter the wet section is checked The system is filled with gas to equilibrate the measuring chambers 4 The entire measuring path is filled with CAL 1 rinse solution The calibratio...

Page 121: ...ated on CAL2 and status calibrated on CAL1 For further information on the pH cK cNa cCa2 cCl calibration see Calibration of the pH and electrolyte sensors in section pH and electrolyte sensors in chapter 5 in this manual pH cK cNa cCa2 cCl are sensitivity calibrated once a day and status calibrated with every measurement ctHb and ctBil are sensitivity calibrated on S7770 ctHb Calibration Solution ...

Page 122: ...suring chambers 3 The result is saved in the Quality Control log 4 The result is compared with the defined control range measuring range and statistics range 5 The absence of any markings next to a parameter indicates that a parameter was measured without any fault Marking Explanation Error in the previous calibration or analyzer malfunction W A violated Westgard Rule R A violated RiLiBÄK rule Par...

Page 123: ...ts the inlet handle to the syringe position Press Ampoule QC 3 The adapter is pressed against the inlet gasket and the inlet probe extends into the sample which is automatically aspirated NOTE It is mandatory to use the adapter to minimize the risk of possible glass pieces from the ampoule getting into the system of the analyzer 4 When the aspiration is finished close the inlet The screen is now r...

Page 124: ...3 Wet section ABL90 FLEX reference manual 3 10 ...

Page 125: ...4 Electronics General information 4 2 Electronic boards and components 4 3 ...

Page 126: ...puter module An integrated thermal printer Electronics for control of the wet section pump valve sensor cassette solution pack and flow selector Interface to electronic chip for solution pack identification Power supply unit Inlet positioning Sample mixer Communication between an external data management computer and the analyzer may be achieved via a serial RS232 interface or Ethernet connection ...

Page 127: ...rs and integrated analog to digital converters to acquire sensor signals and transmit those data to Wet Section Control Selector Detector The Selector Detector PCB handles the position detection of the selector function in the liquid cassette It communicates with the Wet Section Control through an I2C interface Cassette Instrument ID The Cassette Instrument ID PCB handles data collection for the i...

Page 128: ...tive touch panel and an Interface PCB for LVDS signal backlight and touch control Barcode Reader The barcode reader acts as input device for consumables user and patient barcodes It includes a laser scan engine a proximity sensor a buzzer and a serial interface The 4 printer unit handles printouts of instrument and patient results The printer unit includes a 4 clamp shelf printer mechanism a DC DC...

Page 129: ...ion of the pH and electrolyte sensors 5 20 Measurement pH and electrolytes 5 21 pCO2 sensor 5 22 Construction of the pCO2 sensor 5 23 Measuring principle of the pCO2 sensor 5 24 Calibration of the pCO2 sensor 5 26 Measurement pCO2 5 27 pO2 sensor 5 28 Measuring principle of the pO2 sensor 5 29 Calibration of the pO2 sensor 5 30 Measurement pO2 5 31 Metabolite sensors 5 32 Construction of the metab...

Page 130: ... individual sensor as part of the sensing array within a sensor cassette The electrical signal from each sensor is measured by proprietary analog electronics contained within the analyzer unit The sensors are located on sensor boards in the sensor cassette Top sensor board K Na pCO2 pH Cl Ca pO2 Ref Bottom sensor board Lac Glu Sensors ...

Page 131: ...nerates an absorption spectrum used to calculate oximetry parameters This measuring principle is used for measuring ctHb sO2 FO2Hb FCOHb FHHb FMetHb FHbF and ctBil The first three measuring principles are described under the sensors where they are applied Spectrophotometry is described in the section titled ctHb and derivates Strictly speaking in potentiometry the potential of a sensor chain is re...

Page 132: ...5 Sensors and optical system ABL90 FLEX reference manual 5 4 Calibration General information 5 5 The calibration equation 5 6 Sensitivity 5 7 Measurement 5 8 Quality management 5 9 ...

Page 133: ... all sensors is performed using air CAL 1 also used for rinse CAL 2 and CAL 3 see chapter 9 Solutions for more information on the solutions The calibration solutions contain known concentrations of the substrates to be measured These concentrations are vital in determining the measurement accuracy of the analyzer The concentration of each substance in the calibration solutions is programmed into t...

Page 134: ... illustrate how this equation is derived from two solutions of known pH The pH value as graphed is a linear scale All other electrolyte values if graphed would be expressed as log10 aion Solution 1 s1 has a pH of 7 40 which gives a potential reading of 2 3 mV Solution 2 s2 has a pH of 7 03 which gives a potential reading of 20 4 mV These two values are plotted on a graph The relationship between p...

Page 135: ...The sensitivities are range checked pH pCO2 pO2 cK cNa cCa2 cCl cGlu cLac pA mmol L pA mmol L Min 85 60 85 85 85 85 75 100 100 Max 105 105 105 105 105 105 105 2000 2000 The calibration line slope is re established with every calibration The slope of the calibration line is described by the sensitivity value The calibration status values are in general defined as the sensor signals of CAL 1 except ...

Page 136: ...below this potential corresponds to a pH of 7 35 To compensate for deviations from ideal behavior ex dilution of sample with residual rinse solution and change in gas level by contact with the sample path a correction is applied to give the final value The correction is typically a linear correction and is described for each sensor type in the following Sample measurements Corrections ...

Page 137: ...ette To check the expiration date lifetime conditioning time and sensitivity of all the parameters The activities mentioned under analysis check are also checked These checks are performed after sensor cassette installation Solution pack To check the expiration date lifetime and number of remaining tests along with the correct solution pack positioning and sample flow integrity These checks are pe...

Page 138: ... a measurement if no scheduled calibration has been performed thus compensating for the drift The temperature is monitored and logged during aspiration of sample QC and Cal solutions Sensor checks During sensor response checks the signal responses of the sensors are checked Stability errors are reported by an error message and a next to the parameter results During calibration checks the calibrati...

Page 139: ... the activity is retried If this activity fails the User intervention required mode is entered Consumables checks During consumables check the sensor cassette and the solution pack lifetime and expiration date are checked by inspecting the smart chip data of the individual consumables In case of chip data errors or if the consumables are used up or have expired the User intervention required mode ...

Page 140: ...alculate the pO2 in the measurement or in other words actually to perform a calibration to ensure a valid calibration After sensor replacement the metabolite sensors have a significant drift in the sensitivity The analyzer automatically compensates for this by performing a calibration when needed after every measurement that is used to calculate the measured metabolite values By performing the cal...

Page 141: ...ABL90 FLEX reference manual 5 Sensors and optical system 5 13 Reference electrode Background information about the reference electrode 5 14 Construction of the reference electrode 5 15 ...

Page 142: ... is maintained at the reference electrode by the following equilibrium reactions AgCl Ag Cl Ag e Ag These reactions are possible because the electrode is made of an Ag rod coated with AgCl to provide the Ag Ag equlibrium in a solution with constant Cl concentration and to determine the reference potential The reference electrode is used in the measurement of pH and electrolyte concentrations Conta...

Page 143: ...on Acts as a salt bridge solution that maintains an electrical contact between the electrode and the sample 3 Electrode Provides the contact between the Electrolyte solution and the electrical contact 4 Electrical contact The point of electrical contact between the electrode and the analyzer 5 Housing Sensor cassette housing with integrated reference electrode Diagram Parts and functions ...

Page 144: ...erence manual 5 16 pH and electrolyte sensors Construction of the pH and electrolyte sensors 5 17 Measuring principle of the pH and electrolyte sensors 5 18 Calibration of the pH and electrolyte sensors 5 20 Measurement pH and electrolytes 5 21 ...

Page 145: ...sensor is used as an example 3 1 4 1 2 3 4 Item Part Description 1 Membrane Ion selective membrane that is in direct contact with the sample or calibration solution and that is sensitive to a specific ion e g the H ions 2 Solid state contact The point of electrical and ionic contact with the membrane 3 Electrical contact The point of electrical contact between the sensor and the analyzer 4 Electro...

Page 146: ...nection to the voltmeter 3 Liquid junction Point of contact between the reference sensor and the sample 4 Sample The unknown liquid being measured 5 Membrane An ion sensitive membrane which is sensitive to H electrolyte ions 6 Solid state contact Provides electrical connection to the voltmeter Every element in the electrode chain contributes a voltage to the total potential drop through the chain ...

Page 147: ...e internal solid state reference electrode fixes the internal potential changes in the external charging of the membrane produce measurable changes in the overall potential Having measured the unknown potential Esample the potential difference across the membrane in the sensor can be expressed by the Nernst equation sample 0 x R E E ln F n T a where E0 Standard electrode potential R Gas constant 8...

Page 148: ...e pH and electrolyte values for CAL 1 and CAL 2 are as follows approximate values Level Substance Unit CAL 1 CAL 2 pH 7 3 6 8 cNa mmol L 150 70 cK mmol L 4 10 cCl mmol L 95 50 cCa2 mmol L 0 5 2 3 The solution pH and electrolyte values are known and contained in the solution pack smart chip The sensitivity is calculated in the following way and expressed as the percentage of the theoretical sensiti...

Page 149: ...lowing equations n E E sample cal1 61 5mV S cal1 c c 10 where n is the ionic charge The measured value is applied a linear correction displayed 1 2 c k c k NOTICE cCl is compensated for cHCO3 interference by using the measured pH and pCO2 before the linear correction is applied The following parameters are range checked Sensitivity Sensitivity drift Status Sensor response stability The sensor resp...

Page 150: ...tical system ABL90 FLEX reference manual 5 22 pCO2 sensor Construction of the pCO2 sensor 5 23 Measuring principle of the pCO2 sensor 5 24 Calibration of the pCO2 sensor 5 26 Measurement pCO2 5 27 Corrections pCO2 5 27 ...

Page 151: ...pH membrane Ag AgCl sensors The electrolyte solution is vented by CO2 whereby pH is changed 3 pH membrane H sensitive membrane 4 Reference Ag AgCl electrode 5 Solid state contact for the pH system The point of electrical contact between the pH membrane and the analyzer 6 Solid state contact for the Ag AgCl system The point of electrical contact between the reference electrode and the analyzer 7 El...

Page 152: ...o the voltmeter 3 Electrolyte solution Medium for connection 4 Internal reference electrode Ag AgCl Provides electrical connection to the voltmeter The potential differences at all the junctions in the electrode chain are known and constant except that at the pH sensitive membrane See the section pH and electrolyte sensors for a full explanation The potential difference at the pH sensitive membran...

Page 153: ...embrane This change in potential across the membrane is measured by the voltmeter Relation of pH to pCO2 The pH value is related to the partial pressure of CO2 in the sample by the following equation 2 3 a HCO log pK pH pCO where a pK log Ka the equilibrium constant for the dissociation of carbonic acid in water solubility coefficient for CO2 in water The structure of the pCO2 sensor is similar to...

Page 154: ...pped with a solution pack This pack contains precision tonometered fluids The tonometry calibration gas mixture is of a known composition The partial pressure of CO2 pCO2 and the solution pH values are known and contained in the solution pack smart chip The sensitivity is calculated in the following way and expressed as the percentage of the theoretical sensitivity calculated from the sensor signa...

Page 155: ... the sample mVsample E E sample cal1 61 5mV S 2 2 CO CO cal1 10 p p The measured value is applied a linear correction displayed 1 2 c k c k The following parameters are range checked Sensitivity sensitivity drift status sensor response stability The sensor response stability is defined as the standard deviation of the last 5 updatings of the response Measurement Checks ...

Page 156: ...5 Sensors and optical system ABL90 FLEX reference manual 5 28 pO2 sensor Measuring principle of the pO2 sensor 5 29 Calibration of the pO2 sensor 5 30 Measurement pO2 5 31 ...

Page 157: ...a dichroic mirror onto the pO2 sensor Due to the phosphorescence red light is emitted back through the dichroic mirror and onto a photo detector The photo detector sends the electrical signals proportional to the light intensity to the analog digital converter and the data processing unit The calculation of the pO2 is performed The pO2 is calculated on the basis of the Stern Volmer equation which ...

Page 158: ...h water vapor 2 2 2 O ref O p amb pH O p F where FO2 is the pO2 fraction in ambient air and pH2O is the partial water vapor pressure of saturated air at 37 o C and p amb is the barometric pressure In connection with the sensitivity calibration performed on ambient air also the CAL1 rinse solution is measured to obtain a status This status aims to check the performed calibration This is done by com...

Page 159: ...ue is applied a 2nd order blood correction to compensate for the varying buffer value of blood as a function of pO2 tension A second order correction is applied 2 2 1 2 2 2 3 O display k O k O k p p p NOTICE During a measurement the sensor technology used offers detection of any air bubble in front of the pO2 sensor that could lead to significant errors The following parameters are range checked S...

Page 160: ...ystem ABL90 FLEX reference manual 5 32 Metabolite sensors Construction of the metabolite sensors 5 33 Calibration of the metabolite sensors 5 34 Measurement metabolites 5 35 Measuring principle of the metabolite sensors 5 36 ...

Page 161: ...se lactate oxidase 4 Inner membrane Cellulose acetate 5 Reference Ag AgCl electrode 6 Anode Platinum electrode 7 Cathode Platinum electrode 8 Electrode base The structural platform on which the sensor is formed The zero current is a small background current measured at the electrode when no cGlu cLac is present in a solution As CAL 1 contains no cGlu cLac a baseline representing the zero current I...

Page 162: ...inal glucose concentration of 10 mmol L and a nominal lactate concentration of 10 mmol L The precise values are specific to the individual lot of the solution pack and are contained in the solution pack smart chip The current at the cGlu and cLac sensors with CAL 3 in the measuring chamber is measured at regular intervals after the chamber is filled with solution The current when signal stability ...

Page 163: ...ICE cLac is compensated for the dependence of the ionic composition by using the measured electrolyte values before the linear correction is applied If the electrolytes are not measured default values are used The following parameters are range checked Sensitivity Sensitivity drift Sensor response stability The sensor response stability is defined as the standard deviation of the last 5 updatings ...

Page 164: ...escription 1 Amperemeter Measures the current flowing through the circuit in nanoamperes 2 Cathode Negative electrode where a reduction reaction occurs and electrons are consumed 3 Membrane Allows the appropriate molecules to pass through from the sample 4 Sample Contacts the membrane 5 Electrolyte Provides electrical contact between the anode and cathode 6 Anode Positive electrode where an oxidat...

Page 165: ...atinum anode The H2O2 produced by the enzyme reaction is transported across the inner membrane to the platinum anode When a potential is applied to the electrode chain the oxidation of H2O2 produces an electrical current proportional to the amount of H2O2 which in turn is directly related to the amount of glucose lactate H2O2 2H O2 2e At the counter electrode a reduction process consuming electron...

Page 166: ...sors and optical system ABL90 FLEX reference manual 5 38 ctHb and derivates General information 5 39 Calibration of the optical system 5 44 Correcting for interferences 5 45 Measurement and corrections 5 47 ...

Page 167: ...he sum of unconjugated and conjugated bilirubin in plasma NOTICE ctBil can be measured on a whole blood or plasma sample Plasma samples provide the optimal measurement performance To obtain optimal accuracy when following a patient trend in ctBil use the same sample type and the same analyzer The optical system is based on a 138 wavelength spectrophotometer with a measuring range of 467 672 nm The...

Page 168: ...The light passes through a slit that directs it towards an arrangement of mirrors and a grating 6 The grating separates the light into the colors of the rainbow and the mirror focuses the light on a photodiode array 7 The photodiode array has 256 diodes or pixels one for each wavelength which convert the monochromatic light signals to currents 8 The currents and therefore the intensity of the ligh...

Page 169: ...lly active compound the total absorbance Atotal is the sum of the individual compounds absorbance since absorbance is an additive quantity For example if a sample contains six compounds y1 y2 y6 the total absorbance measured for that sample at wavelength 1 is 1 1 1 1 1 1 6 1 2 3 4 5 1 y total y y y y y A A A A A A A 1 1 1 1 1 1 1 2 3 4 5 6 1 2 3 4 5 6 y y y y y y y y y y y y l c c c c c c If there...

Page 170: ... unconjugated bilirubin at a concentration of 200 µmol L The spectrum of conjugated bilirubin is slightly different In the spectrum taken of a sample the absorption recorded at each wavelength contains contributions from each of the compounds in the sample The task then is to determine the magnitude of that contribution and thereby the concentration of each compound in the sample The concentration...

Page 171: ...determined using Multivariate Data Analysis 2 where the spectra of the calibration compounds are considered together with the reference values of the calibration compounds The essential interfering substances intralipids and sulfhemoglobin were also taken into account Matrix of constants ...

Page 172: ...zero point Io is measured automatically during system start up and during calibrations The cuvette path length i e the length of the light path is determined from Lambert Beer s Law by measuring the absorbance of the colored dye present in the tHb Calibration Solution S7770 which has a known equivalent hemoglobin concentration Beer s Law A ε x Cdye x l where A absorbance ε extinction coefficient C...

Page 173: ...s aged 0 3 months then a deviation in the measurement will arise The deviation is most important for measurements of oxygen saturation sO2 and FO2Hb and the fraction of carboxyhemoglobin FCOHb since inaccurate measurements of these parameters can lead to incorrect diagnostic interpretation of the results and consequent risk of inappropriate treatment The presence of HbF in a sample is detected fro...

Page 174: ...pectrum If this residual spectrum is too high the oximetry module parameters ctHb sO2 FO2Hb FCOHb FMetHb FHHb FHbF and ctBil will be flagged with a warning In addition a warning will accompany the results if any of the following conditions exist ctHb 0 1 mmol L or ctHb 25 mmol L FHb deriv 2 or FHb deriv 102 where FHb deriv is defined as sO2 FO2Hb FCOHb FMetHb FHHb SHb 2 or SHb 10 Value of Turbidit...

Page 175: ...of deoxyhemoglobin in the sample cMetHb concentration of methemoglobin in the sample cHbF concentration of fetal hemoglobin in the sample is not measured directly but determined on the basis of a definition equation Bilirubin is calculated as follows Hct calc 1 tBil B tBil P c c where ctBil P concentration of total bilirubin in plasma ctBil B concentration of diluted plasma bilirubin after sample ...

Page 176: ...r limit value for cO2HbF is required i e even adult blood samples will be corrected for HbF It may be of value when analyzing blood samples from newborns who have received adult blood transfusion In these cases FHbF can be lower than 20 and significant deviations of oximetry parameters and bilirubin can occur HbF correction Disabled No HbF corrections made HbF suppression has been activated The FH...

Page 177: ...corr F c c where ctHb sample corr corrected ctHb Fcuv analyzer dependent cuvette path length constant determined at tHb calibrations and automatically stored by the analyzer The uncorrected total bilirubin concentration ctBil sample measured on capillary or syringe samples is corrected as follows cuv tBil sample tBil sample corr F c c Fcuv is the same as for tHb Corrections for ctHb Corrections fo...

Page 178: ...hemical analysis 5th ed McGraw Hill 1985 3 Martens H Multivariate calibration quatitative interpretation of non selective chemical data Dr Techn Thesuis NTH Univ of Trondheim 1986 4 Krzeminski A Why correct for fetal hemoglobin in blood oximetry measurements Radiometer Publication Info No 1992 3 Copenhagen Radiometer Medical A S 1992 5 Huehns ER Beanen GH Developmental changes in human hemoglobins...

Page 179: ...ser defined corrections General information 6 2 Correction factors for pH and blood gases 6 4 Correction factors for oximetry parameters 6 5 Correction factors for electrolyte and metabolite parameters 6 8 ...

Page 180: ...ns and the displayed values with user defined corrections The correction factors for each measured parameter are the slope and the offset of the correction line With user defined corrections it is possible to change the values of either one or both of these correction factors depending on the parameter type Corrected value Slope Uncorrected value Offset The diagram below is a schematic representat...

Page 181: ...LEX analyzer and the reference analyzer using the ABL90 FLEX analyzer as an independent variable The user must verify the corrections that are entered Details of these procedures may be found in the section Test conditions in chapter 7 The slope offset for each parameter are configured in General Setup Parameters and Input Parameters User corrected values are marked with a after the result NOTICE ...

Page 182: ...n factors for pH and blood gases The following corrections to the slope and offset are possible within the stated limits for Arterial venous and a v samples Parameter Slope Offset pH 0 80 1 20 0 05 pCO2 0 80 1 20 10 mmHg pO2 0 80 1 20 20 mmHg Correcting slope and offset ...

Page 183: ... on the ABL90 FLEX analyzers should be made without any entered corrections To avoid truncation errors from an enabled Out of range suppression function it is important to disable the function The following recommendations apply to the oximetry parameters Item Description Units g dL g L mmol L Sample Set ctHb of a SAT100 sample to 15 g dL 9 3 mmol L and pH 7 4 ctHb maximum point Uncorrected or cor...

Page 184: ... 7 4 The Enabled for all levels HbF Correction function should be enabled in order to have the FHbF value displayed for the adult sample Averaging repeated measurements on blood from different donors gives an optimized accuracy of the correction Averaging repeated measurements on blood from the same donor also improves the accuracy Slope 0 800 1 200 Offset 0 20 The units for FO2Hb and FHHb are Fra...

Page 185: ...L and maximum point could be an unconjugated bilirubin sample neonatal with ctBil 300 400 mol L Averaging repeated measurements on samples from different donors gives an optimized accuracy of the correction Averaging repeated measurements on samples from the same donor also improves the accuracy Commercial bilirubin standards can interfere with bilirubin measurement because they may have an absorb...

Page 186: ... samples Parameter Slope Offset cK 0 80 1 20 1 0 mmol L cNa 0 80 1 20 10 mmol L cCa2 0 80 1 20 1 00 mmol L cCl 0 80 1 20 10 mmol L cGlu 0 750 1 250 5 0 mmol L cLac 0 750 1 250 5 0 mmol L The Radiometer default values for the electrolyte and metabolite parameters must be reset manually by the user on the Parameter setup screen to 1 000 for each parameter Correcting slope and offset Resetting correc...

Page 187: ...formance test results cNa 7 10 Performance test results cCl 7 10 Performance test results cCa2 7 11 Performance test results cGlu 7 11 Performance test results cLac 7 12 Performance test results ctHb 7 13 Performance test results sO2 7 14 Performance test results FO2Hb 7 15 Performance test results FCOHb 7 15 Performance test results FMetHb 7 16 Performance test results FHHb 7 17 Performance test ...

Page 188: ...tween the ABL90 FLEX analyzer and the ABL735 analyzer Performance specifications of the ABL90 FLEX analyzers are described using the following BiasPrim ref the mean difference between the ABL90 FLEX analyzer and the primary reference methods BiasSec ref the mean difference between the ABL90 FLEX analyzer and the ABL735 analyzer Repeatability imprecision estimate Reproducibility imprecision estimat...

Page 189: ... and a liquid junction saturated with KCl BMS Mk2 The calibration standards are traceable to the Primary Reference Standards for pH ABL735 Ref 1 2 pCO2 Tonometry The gases used for tonometry are traceable to NIST certified Standard Reference Materials N A Ref 3 pO2 Tonometry The gases used for tonometry are traceable to NIST certified Standard Reference Materials N A Ref 3 cCa2 Calcium transfer st...

Page 190: ... 5 6 CO2 dithionite ABL735 FO2Hb Measured according to the following relation FO2Hb 1 FHHb FCOHb FMetHb ABL735 FHHb 0 whole blood is tonometered with a gas mixture containing 94 4 N2 and 5 6 CO2 dithionite ABL735 FCOHb Gas chromatography The Standards are carbon monoxide mixtures with atmospheric air whose purity is validated in accordance with NIST SRM 1678 50 ppm CO in N2 ABL735 FMetHb Spectrome...

Page 191: ...er Ref 9 Parameter Description S0 Repeatability This is a standard deviation obtained from repeated measurements within a short interval of time using The same instrument and location The same measurement procedure Identical portions of the same sample One operator per instrument S0 for each level is pooled for all test instruments and test days Sx Reproducibility is obtained from repeated measure...

Page 192: ...althy voluntary donors The blood is prepared to obtain different concentration levels of each measured parameter Blood measurements Measurements on every parameter are performed on all analyzers with 5 measurements on every sample of each run repeated for 3 days The measurements were performed by different operators Solution pack All calibration solutions and gases used for the tests are traceable...

Page 193: ...of measurements during the test are listed below Parameter Number of measurements Test period days Number of Instruments pH 786 30 8 pCO2 691 25 10 pO2 917 27 9 cK 800 13 10 cNa 799 30 8 cCa2 797 30 8 cCl 799 30 8 Blood 1268 23 9 cGlu Serum pool 408 23 9 Blood 1622 22 8 cLac Serum pool 546 22 8 ctHb 1042 8 10 sO2 1193 22 10 FO2Hb 1193 22 10 FCOHb 1041 12 10 FMetHb 1049 9 10 FHHb 1193 22 10 FHbF 86...

Page 194: ...BiasSec ref S0 SX TEA 6 800 0 007 0 0014 0 0076 0 022 7 000 0 004 0 0012 0 0064 0 017 7 200 0 002 0 0014 0 0064 0 015 7 400 0 002 0 0014 0 0073 0 016 7 800 0 006 0 0017 0 0113 0 028 Performance test results pCO2 Tonometry Ref 3 The gases used for tonometry are traceable to NIST certified Standard Reference Materials pCO2 mmHg BiasPrim ref S0 SX CVX TEA TEA 15 0 0 13 0 16 0 70 4 7 1 50 10 0 40 0 0 ...

Page 195: ... test results cK NIST certified Standard Reference Material SRM 909b human serum cK mmol L BiasPrim ref N 5 973 0 065 45 3 983 0 067 45 1 987 0 108 45 N number of measurements on several analyzers used for the test BiasABL90 Prim ref BiasABL90 ABL735 BiasABL735 Prim ref cK mmol L BiasSec ref S0 SX CVX TEA TEA 2 0 0 09 0 02 0 08 4 0 0 25 12 3 4 0 0 09 0 01 0 08 2 0 0 25 6 2 6 0 0 12 0 01 0 11 1 8 0...

Page 196: ...ST through Na ABL735 corr 1 055 Na ABL735 meas 6 8966 mM Performance test results cCl NIST certified Standard Reference Material SRM 909b human serum cCl mmol L BiasPrim ref N 89 11 0 8 45 119 45 3 45 45 N number of measurements on several analyzers used for the test BiasABL90 Prim ref BiasABL90 ABL735 BiasABL735 Prim ref cCl mmol L BiasSec ref S0 SX CVX TEA TEA 80 0 8 0 1 0 9 1 1 2 56 3 2 100 0 8...

Page 197: ...f S0 SX CVX TEA TEA 0 5 0 031 0 002 0 015 3 0 0 060 12 0 0 75 0 011 0 002 0 014 1 9 0 038 5 1 1 25 0 013 0 003 0 017 1 4 0 046 3 7 1 75 0 044 0 005 0 024 1 4 0 091 5 2 2 50 0 063 0 010 0 037 1 5 0 136 5 4 Performance test results cGlu Spectrophotometry using the hexokinase HK method recommended by NCCLS CLSI Ref 5 measured on serum Blood pO2 90 mmHg cGlu mmol L BiasPrim ref S0 SX CVX TEA TEA 2 0 0...

Page 198: ... 0 23 11 4 6 0 0 07 0 03 0 13 2 2 0 32 5 4 10 0 0 23 0 04 0 24 2 4 0 70 7 0 25 0 0 87 0 17 0 72 2 9 2 3 9 1 40 1 58 0 45 1 36 3 4 4 3 10 6 Performance test results cLac Spectrophotometry using a lactate dehydrogenase LDH method measured on serum Ref 10 Blood pO2 90 mmHg cLac mmol L BiasPrim ref S0 SX CVX TEA TEA 0 3 0 03 0 01 0 08 26 7 0 19 62 3 1 0 0 03 0 05 0 12 12 0 0 27 27 0 5 0 0 09 0 07 0 22...

Page 199: ...3 4 0 42 8 4 10 0 0 19 0 04 0 45 4 5 1 07 10 7 15 0 0 29 0 06 0 78 5 2 1 82 12 1 25 0 06 0 16 1 92 7 7 3 82 15 3 Performance test results ctHb HiCN method recommended by NCCLS Ref 6 Setup Adult samples HbF correction is not activated ctHb g dL sO2 BiasPrim ref S0 SX CVX TEA TEA 0 00 0 02 0 01 0 02 0 06 3 5 100 0 02 0 04 0 08 2 3 0 18 5 1 7 0 100 0 05 0 08 0 16 2 3 0 36 5 1 10 0 100 0 06 0 07 0 20 ...

Page 200: ... 148 N number of measurements on several analyzers used for the test Setup Adult samples HbF correction not activated BiasABL90 Prim ref BiasABL90 ABL735 BiasABL735 Prim ref ctHb g dL sO2 BiasSec ref S0 SX CVX TEA TEA 15 0 0 09 0 07 0 25 0 58 15 50 0 26 0 24 0 40 0 8 1 04 2 1 15 65 0 20 0 27 0 46 0 7 1 10 1 7 15 75 0 10 0 30 0 48 0 6 1 04 1 4 15 90 0 10 0 19 0 35 0 4 0 79 0 9 15 100 0 07 0 24 0 40...

Page 201: ... 01 1 1 100 0 15 0 10 0 16 0 38 0 4 0 84 0 8 100 0 7 0 09 0 19 0 48 0 5 1 03 1 0 100 0 25 0 45 0 18 0 53 0 5 1 49 1 5 Performance test results FCOHb Gas chromatography The Standards are carbon monoxide mixtures with atmospheric air whose purity is validated in accordance with NIST SRM 1678 50 ppm CO in N2 Setup Adult samples HbF correction is not activated ctHb g dL FCOHb BiasPrim ref N 15 0 0 22 ...

Page 202: ...tup Adult samples HbF correction is not activated ctHb g dL FMetHb BiasPrim ref N 15 0 0 12 45 15 20 0 76 45 N number of measurements on several analyzers used for the test BiasABL90 Prim ref BiasABL90 ABL735 BiasABL735 Prim ref ctHb g dL FMetH b BiasSec ref S0 SX CVX TEA TEA 15 0 0 0 04 0 10 0 23 0 49 15 5 0 0 02 0 09 0 25 5 0 0 51 10 2 15 10 0 0 04 0 12 0 33 3 3 0 69 6 9 15 20 0 0 18 0 08 0 27 1...

Page 203: ... 1 04 Performance test results FHbF The reference method is based on Cation Exchange HPLC The method is described in Ref 15 The method is performed by the Hæmatology Laboratory at Herlev Hospital Denmark Setup Mixed adult and Fetal samples HbF correction enabled for all levels FHbF ctHb g dL BiasPrim ref S0 SX CVX TEA TEA 0 15 1 6 1 8 3 0 7 48 5 15 3 2 1 8 3 3 66 9 67 193 10 15 0 9 1 7 3 2 32 7 17...

Page 204: ...1 89 14 9 186 100 15 0 2 3 2 9 7 9 7 19 2 19 2 200 15 4 8 3 6 12 7 6 4 29 7 14 9 400 15 5 3 4 8 13 9 3 5 32 5 8 1 600 15 11 7 5 9 18 0 3 0 47 0 7 8 NOTES a Adult fetal blood pH 7 4 0 1 normal MCHC and albumin variation Spiked with unconjugated bilirubin The purpose of the bilirubin external tests was to make a regression study of ABL90 bilirubin against reference hospital analyzers on hospital neo...

Page 205: ...ve bias of 18 on whole blood samples The patient samples represented typical variations in ctBil ctHb sO2 pH and MCHC Mean Corpuscular Hemoglobin Concentration values Three external tests were carried out at two different sites Each test had its own ABL90 analyzer a total of three Wet Chemistry analyzer Roche Modular with Roche Calibrator was used as a reference Ref 21 Each external test site had ...

Page 206: ...s the deviation from the correct result Ref 14 The following interference results are found for the pH and blood gas electrodes Interference on Substance Test Concentration pH level 7 4 pCO2 pO2 mmHg Test matrix 2 0 010 N A 1 Blood Aqueous Intralipid 5 0 010 N A 1 Blood Aqueous Fluorescein 400 mg L N A N A 1 Blood K 17 mM 0 010 N A N A Blood Na 190 mM 0 010 N A N A Blood Ca2 5 5 mM 0 010 N A N A B...

Page 207: ...s Zinc Zn2 170 M 0 1 1 0 024 N A Plasma Strontium Sr2 150 M N A N A 0 02 N A Plasma N A N A 0 037 mM pH N A Aqueous buffer pH 6 8 8 N A N A N A 1 Plasma 37 5 mM N A N A N A 76 6 Plasma 18 75 mM N A N A N A 37 6 Plasma 10 mM N A N A N A 19 5 Plasma 5 mM N A N A N A 10 1 Plasma Bromide Br 1 mM N A N A N A 1 8 Plasma 2 99 mM N A N A N A 12 4 Plasma 1 5 mM N A N A N A 5 3 Plasma 1 mM N A N A N A 3 5 P...

Page 208: ... Plasma 2 17 mM N A N A N A 1 7 Plasma Salicylic acid 4 34 mM N A N A N A 5 2 Plasma 0 43 mM N A N A N A 4 8 Plasma 0 57 mM N A N A N A 5 5 Plasma 0 86 mM N A N A N A 8 7 Plasma Thiocyanic acid 1 72 mM N A N A N A 17 2 Plasma 170 M N A N A N A 1 Plasma Ascorbic acid 850 M N A N A N A 1 Plasma 1 mM N A N A N A 1 Plasma Citrate 40 mM N A N A N A 4 9 Plasma 1 mM N A N A N A 1 Plasma Oxalate 10 mM N A...

Page 209: ...nohydrate 5 mM 0 1 0 1 Whole blood Mannose 1 mM 0 11 0 1 Whole blood Salicylic acid 4 34 mM 0 1 0 1 Whole blood 6 mM 14 39 10 95 Whole blood 8 mM 19 31 14 57 Whole blood 12 mM 31 08 21 91 Whole blood Sodium thiocyanate 24 mM 94 69 58 75 Whole blood Xylose 1 mM 0 1 0 1 Whole blood Acetoacetate Lithium acetacetoacetate 2 mM 0 1 0 11 Whole blood Creatinine 3 mM 0 1 0 1 Whole blood Galactose 3 3 mM 0 ...

Page 210: ...ration Glu mM Lac mM Test matrix 2 5 mM 2 25 N A Whole blood 3 33 mM 2 88 N A Whole blood 5 mM 4 58 N A Whole blood 2 deoxy Glucose 10 mM 9 58 0 1 Whole blood Unconjugated Bilirubin 0 2 g L 0 1 0 1 Whole blood Conjugated Bilirubin 0 2 g L 0 1 0 1 Whole blood Ascorbic acid 300 mg dL 0 1 0 1 Whole blood ...

Page 211: ...1 3 1 21 30 Fluorescein 250 mg L 1 31 3 2 9 5 4 1 10 7 2 9 ND 1115 beta carotene 3 7 µmol L 0 5 1 1 1 1 1 20 30 Patent Blue V 10 mg L 0 5 1 1 5 1 1 1 ND 30 10 mg L 0 5 1 3 7 1 3 2 1 ND 30 30 mg L 1 63 2 7 13 7 1 11 2 2 8 ND 83 Methylene Blue 60 mg L 3 01 4 2 27 8 1 2 21 5 5 1 ND 154 7 mg L 0 5 1 1 1 1 1 20 30 Cardio Green 30 mg L 0 5 1 1 6 1 1 2 1 ND 30 Evans Blue 5 mg L 0 5 1 1 1 1 1 20 30 2 0 5 ...

Page 212: ... FHbF 7 15 15 8 7 25 8 2 7 4 0 7 5 4 1 7 6 7 7 MCHC Mean Corpuscular Hemoglobin Concentration is used to estimate hematocrit Hct which is used in the ctBil measurement MCHC is an average Hb concentration in the red blood cell RBC If the RBC volume decreases MCHC increases If an RBC has iron deficit MCHC decreases Hct is determined from ctHb as follows tHb Hct MCHC c A standard value of 332 g L is ...

Page 213: ... 43 0 43 0 40 0 40 0 51 0 65 0 42 0 56 0 39 0 51 0 39 0 50 0 37 0 50 0 37 0 49 0 36 0 50 0 36 0 51 0 36 0 46 0 36 0 47 340 320 330 320 300 300 300 280 280 290 330 350 310 330 320 340 310 330 290 310 290 310 290 310 270 290 270 290 280 300 If MCHC is defined as MCHC 332 g L MCHC then the contribution to the relative error on the ctBil measurement is as follows tBil Hct MCHC tBil 1 Hct MCHC c c A wo...

Page 214: ... disodium affects cGlu results Sodium fluoride gives erroneously high cNa and low cCa2 cGlu and cLac results Trisodium citrate affects cNa cK and cGlu results Radiometer therefore recommends the use of heparin as the only anticoagulant WARNING Risk of erroneous results Do not use EDTA as it leads to erroneous pH pCO2 cNa cK and cCa2 results Use of EDTA will also affect subsequent measurements on t...

Page 215: ...ical Chemistry Devices Approved Guidelines EP5 A Vol 19 No 2 12 CLSI Protocols for Determination of Limits of Detection and Limits of Quantitation Approved Guidelines EP17 A Vol 24 No 34 13 CLSI Method Comparison and Bias Estimation Using Patient Samples Approved Guideline Second Edition EP9 A2 Vol 22 No 17 14 CLSI approved guideline for interference testing in clinical chemistry EP7 A Vol 22 No 2...

Page 216: ...7 Performance characteristics ABL90 FLEX reference manual 7 30 ...

Page 217: ...red parameters 8 6 Input parameters 8 13 Derived parameters 8 15 Units and numerical format of derived parameters 8 19 List of equations 8 23 Oxyhemoglobin dissociation curve ODC 8 37 Conversion of units 8 42 Default values 8 44 References 8 45 ...

Page 218: ... However other parameters may also be used such as the difference in alveolar air and arterial blood oxygen tension pO2 A a Oxygen transport Oxygen transport reveals if arterial blood contains sufficient oxygen The oxygen concentration of arterial blood ctO2 a also termed oxygen content is determined by the concentration of total hemoglobin ctHb a the fraction of oxygenated hemoglobin FO2Hb a and ...

Page 219: ... c for concentration F for fraction V for volume etc 2 Component An abbreviation of the component name O2 for oxygen CO2 for carbon dioxide COHb for carboxyhemoglobin etc 3 System Specification of the system B for blood P for plasma a for arterial blood v for mixed venous blood A for alveolar air T for patient temperature Example pO2 a The parameters are listed by symbol in three groups measured i...

Page 220: ...erence ranges must be used with caution as they depend on a number of factors such as sex age and normal physiological condition Critical limits are user defined and can be entered into the analyzer software see section Reference ranges and critical limits in chapter 1 Derived parameters are calculated according to the equations stated If Then the required measured or input values are unknown defa...

Page 221: ...cation screen Arterial Capillary Venous Mixed venous or Not specified Some parameters however are defined for arterial samples only they will be calculated only for sample types entered as Arterial or Capillary The symbol for system blood B or plasma P is not stated in the equations unless it is important for the calculation The units given for each parameter refer to the units available on the an...

Page 222: ...en ions in blood Unit nmol L Range of indication 10 0 501 Reference range 35 5 44 7 m f Is used both for blood and expired air samples Definition Partial pressure or tension of carbon dioxide in blood High and low pCO2 values of arterial blood indicate blood hypercapnia and hypocapnia respectively Unit mmHg kPa Torr Range of indication mmHg Torr 5 0 250 kPa 0 67 33 3 Reference range mmHg 35 48 m 3...

Page 223: ...essure p amb Unit mmHg kPa Torr Range of indication mmHg Torr 450 800 kPa 60 0 106 7 Reference range Conversion of units p kPa 0 133322 p mmHg 0 133322 p Torr p mmHg p Torr 7 500638 p kPa Definition Concentration of total hemoglobin in blood Total hemoglobin includes all types of hemoglobin deoxy oxy carboxy met Unit g dL g L mmol L Range of indication g dL 0 48 27 7 g L 4 8 277 mmol L 0 30 17 2 R...

Page 224: ...inition Fraction of oxyhemoglobin in total hemoglobin in blood Unit fraction Range of indication 2 103 Fraction 0 02 1 03 Reference range 94 98 m f Fraction 0 94 0 98 m f Definition Fraction of carboxyhemoglobin in total hemoglobin in blood Unit fraction Range of indication 2 103 Fraction 0 02 1 03 Reference range 0 5 1 5 m f Fraction 0 005 0 015 m f Default value 0 004 0 4 Definition Fraction of ...

Page 225: ... range neonates 80 m f Fraction 0 80 m f Definition Concentration of potassium ions in plasma Unit mmol L meq L Range of indication mmol L meq L 0 5 25 0 Reference range m f 3 4 4 5 mmol L Conversion of units mmol L meq L Definition Concentration of sodium ions in plasma Unit mmol L meq L Range of indication mmol L meq L 7 350 Reference range m f 136 146 mmol L Conversion of units mmol L meq L Def...

Page 226: ...ctate in plasma Unit mmol L meq L mg dL Range of indication mmol L 0 1 31 meq L 0 1 31 mg dL 1 279 Reference range m f 0 5 1 6 mmol L 4 5 14 4 mg dL Conversion of units cLactate mg dL 9 008 cLactate mmol L cLactate mmol L 0 11101 cLactate mg dL conversion based on the molecular weight of lactic acid Definition Concentration of total bilirubin in plasma Total bilirubin includes its two forms conjug...

Page 227: ...e following table shows the possible ranges and precision number of decimals of the measured parameters These ranges can be narrowed by calculation ranges reportable ranges range of indication etc but should be taken into consideration when external systems are interfaced to the analyzer Numerical format within the following ranges Symbol Unit Range Range pH 4 000 11 000 cH nmol L 999999 0 199 9 2...

Page 228: ...000 0 fraction 10 000 10 000 FHHb 1000 0 1000 0 fraction 10 000 10 000 FHbF 100 200 fraction 1 00 2 00 cK mmol L 0 0 100 0 meq L 0 0 100 0 cNa mmol L 0 1500 meq L 0 1500 cCa2 mmol L 0 00 50 00 meq L 0 00 100 00 mg dL 0 00 200 40 cCl mmol L 0 1000 meq L 0 1000 cGlu mmol L 1 0 24 9 25 150 mg dL 18 2702 cLac mmol L 1 0 14 9 15 100 meq L 1 0 14 9 15 100 mg dL 9 901 ctBil mg dL 5 8 292 3 micromol L 100...

Page 229: ...raction 0 000 1 000 Reference range 35 5 44 7 m f Is used if the analyzer version does not include the oximetry measuring system Definition Concentration of total hemoglobin in blood Input range Unit g dL 0 0 33 0 g L 0 330 mmol L 0 0 20 5 Conversion ctHb g dL 1 61140 ctHb mmol L ctHb g L 16 1140 ctHb mmol L ctHb mmol L 0 62058 ctHb g dL 0 062058 ctHb g L Definition Respiratory quotient ratio betw...

Page 230: ...tal amount of oxygen utilized by the whole organism per unit of time Input range Unit mL min 0 21000 mmol min 0 0 937 1 Conversion mmol min mL min 22 41 Definition Volume of carbon monoxide added to the patient for measurement and calculation of V B 5 Input range Unit 0 0 1000 0 mL Definition The fraction of COHb measured before the CO injection Input range Unit 0 0 100 0 fraction 0 000 1 000 Defi...

Page 231: ...tive values base deficit indicate a relative excess of non carbonic acids dv 5 cBase B ox cBase B of fully oxygenated blood dv 6 cBase Ecf or SBE Standard Base Excess an in vivo expression of base excess 5 6 24 It refers to a model of the extracellular fluid one part of blood is diluted by two parts of its own plasma and is calcu lated using a standard value for the hemoglobin concentration of the...

Page 232: ...oglobin and the hemoglobin minus the dyshemoglobins ms dv 39 Hct Hematocrit the ratio between the volume of erythrocytes and the volume of whole blood dv 13 Symbol Definition Type Eq pO2 T Partial pressure or tension of oxygen at patient temperature dv 14 pO2 A Partial pressure or tension of oxygen in alveolar air dv 15 pO2 A T Partial pressure or tension of oxygen in alveolar air at patient tempe...

Page 233: ...rtial pressure or tension of oxygen in arterial blood and alveolar air at patient temperature dv 25 pO2 x or px Oxygen extraction tension of arterial blood Reflects the integrated effects of changes in the arterial pO2 a ctO2 and p50 on the ability of arterial blood to release O2 to the tissues 8 dv 26 pO2 x T or px T Oxygen extraction tension of arterial blood at patient temperature dv 50 ctO2 B ...

Page 234: ...ference in the concentrations of total oxygen in arterial and mixed venous blood 2 tO a v 2 3 mmol L 5 15 mL dL c dv 34 FShunt T FShunt at patient temperature dv 35 RI Respiratory Index ratio between the oxygen tension difference of alveolar air and arterial blood and the oxygen tension of arterial blood dv 36 RI T Respiratory Index ratio between the oxygen tension difference of alveolar air and a...

Page 235: ...ters are stored as defaults In these instances the dependent derived parameter will not be reported if the relevant input parameter s is are not entered If the default values are used in the calculation of a parameter then a parameter is considered estimated e rather than calculated c The table below lists the electrolyte derived parameters for the analyzers Symbol Unit Analyzer Input parameter Sa...

Page 236: ...a 0 00 9 99 10 0 100 0 cHCO3 P mmol L 0 0 100 0 cBase B mmol L 50 0 50 0 cBase B ox mmol L 100 0 100 0 cBase Ecf mmol L 50 0 50 0 cBase Ecf ox mmol L 100 0 100 0 cHCO3 P st mmol L 0 0 150 0 ctCO2 P mmol L 0 0 100 0 Vol 0 0 224 1 mL dL 0 0 224 1 ctCO2 B mmol L 0 0 100 0 Vol 0 0 224 1 mL dL 0 0 224 1 pH st 4 000 11 000 VCO2 V dry air 10 0 110 0 fraction 0 100 1 100 Hct 10 0 110 0 fraction 0 100 1 10...

Page 237: ...g 0 0 99 9 100 7501 kPa 0 00 9 99 10 0 1000 0 pO2 a T FO2 I mmHg 0 0 99 9 100 7501 kPa 0 00 9 99 10 0 1000 0 pO2 x mmHg 0 0 750 1 kPa 0 00 100 00 pO2 x T mmHg 0 0 750 1 kPa 0 00 100 00 ctO2 B mmol L 0 0 100 0 Vol 0 0 224 1 mL dL 0 0 224 1 ctO2 a v mmol L 0 0 100 0 Vol 0 0 224 1 mL dL 0 0 224 1 BO2 mmol L 0 0 100 0 Vol 0 0 224 1 mL dL 0 0 224 1 ctO2 x mmol L 0 0 100 0 Vol 0 0 224 1 mL dL 0 0 224 1 ...

Page 238: ...ion 0 100 1 100 RI 10 999900 fraction 0 10 9999 00 RI T 10 999900 fraction 0 10 9999 00 Qx fraction 0 10 10 0 VO2 V dry air 10 0 1 100 fraction 0 100 1 100 V B L 0 0 20 0 Anion Gap K mmol L 500 0 500 0 meq L 500 0 500 0 Anion Gap mmol L 500 0 500 0 meq L 500 0 500 0 cCa2 7 4 mmol L 0 00 50 00 meq L 0 00 100 00 mg dL 0 00 200 40 mOsm mmol kg 0 7 3150 0 ...

Page 239: ... 0147 to be in accordance with NCCLS CLSI approved guidelines 24 The change corresponds to 0 1 mpH C Eq 2 9 pH H 10 c T T Eq 3 4 0 019 37 2 2 CO CO 37 10 T p T p NOTICE The formula is different from previous Radiometer analyzers The constant 0 021 is now changed to 0 019 to be in accordance with NCCLS CLSI approved guidelines 24 The change corresponds to 2 5 C Eq 4 24 p pH pK 3 2 HCO P 0 23 CO 10 ...

Page 240: ...e the range of 30 mmol L The change corresponds to less than 0 6 mmol L in the reference ranges for pH pCO2 and ctHb Eq 6 4 O 1 tHb 3062 0 Base B ox Base B 2 s c c c If ctHb is not measured or keyed in the default value will be used If sO2 is not measured it will be calculated from equation 39 Eq 7 24 3 Base Ecf HCO P 24 8 16 2 pH 7 4 c c See NOTICE in Eq 5 Eq 8 cBase Ecf ox cBase Ecf 0 3062 3 1 s...

Page 241: ...t be calculated on the basis of a default ctHb value NOTICE The formula is different from the formula used in previous Radiometer analyzers The previous formula Hct 0 0485 ctHb 8 3 10 3 was changed to ensure that Hct 0 when ctHb 0 The slope was adjusted to make Hct identical for the two formulas when ctHb 9 3087 mmol L The change corresponds to 1 in the ctHb range 6 3 12 3 Eq 14 16 17 The standard...

Page 242: ... for pH pCO2 pO2 and ctHb and T in the interval 32 42 C using FHbF 0 5 Eq 15 5 2 2 1 1 2 2 O A O I amb 6 275 CO RQ O I RQ 1 p F p p F If FO2 I and RQ are not keyed in they are set to the default values The calculation requires entering the sample type as Arterial or Capillary Eq 16 4 5 18 2 2 2 1 1 2 2 O A O I amb H O CO RQ O I RQ 1 p T F p p T p T F 2 2 5 2 36 10 37 0 9 6 10 37 0 2 H O 6 275 10 T...

Page 243: ...on Curve further in this chapter P 50 COHb 1 0 5 1 COHb MetHb p F F F where Description See P ODC S A T Eq 47 0 5 1 COHb MetHb COHb 1 MetHb F F F S F Eq 46 11 A a T 37 0 C Eq 46 13 Eq 20 The ODC is determined as described in equations 46 47 in the section Oxyhemoglobin Dissociation Curve further in this chapter P 50 COHb 1 0 5 1 COHb MetHb p T F F F where Description See P ODC S A T Eq 47 0 5 1 CO...

Page 244: ... pH 7 40 pCO2 5 33 kPa FCOHb 0 FMetHb 0 FHbF 0 Eq 46 13 T 37 0 C Eq 22 2 2 2 O A a O A O a p p p The calculation requires entering the sample type as Arterial or Capillary Eq 23 pO2 A a T pO2 A T pO2 a T The calculation requires entering the sample type as Arterial or Capillary Eq 24 2 2 2 O a O a A O A p p p The calculation requires entering the sample type as Arterial or Capillary Eq 25 2 2 2 O ...

Page 245: ...The calculation requires entering the sample type as Arterial or Capillary Eq 27 5 2 2 2 2 tO O O O 1 COHb MetHb tHb c p s F F c O2 is the concentrational solubility coefficient for O2 in blood here set to 0 0105 mmol L kPa at 37 C 24 ctO2 cannot be calculated on the basis of a default ctHb value NOTICE The formula is different from previous Radiometer analyzers The oxygen solubility coefficient i...

Page 246: ...0 C ctO2 a is determined as described in equation 27 ctO2 x cannot be calculated on the basis of a default ctHb value ctO2 x can only be calculated if the measured sO2 a 0 97 The calculation requires entering the sample type as Arterial or Capillary Eq 31 t Q 2 2 tO O D c Q t is the cardiac output and is an input parameter for the calculation of D O2 If Q t is not keyed in D O2 will not be calcula...

Page 247: ... p c F F s 34 5 2 2 2 tO v 0 0105 O v tHb 1 COHb MetHb O v c p c F F s where pO2 a oxygen tension in arterial blood measured pO2 A oxygen tension in alveolar blood See equation 15 pO2 v oxygen tension in mixed venous blood measured and then entered sO2 a oxygen saturation in arterial blood can be measured sO2 A oxygen saturation in alveolar blood calculated from equation 39 where P pO2 A sO2 v oxy...

Page 248: ...35 4 pO2 A T is calculated from equation 16 35 5 sO2 A T S 35 6 S ODC P A T Eq 47 35 7 P pO2 A T 35 8 pH A a 1 04 37 0 T T 35 9 T patient temperature keyed in 35 10 2 3 pH 1 47 10 6 5 10 pH 37 7 40 T If sO2 a 0 97 the default p50 st 3 578 kPa will be used to determine the ODC 35 11 ctO2 v T ctO2 v at 37 o C is calculated from equation 27 for mixed venous blood values of pO2 and sO2 If no mixed ven...

Page 249: ...n equation 27 Qx cannot be calculated on the basis of a default ctHb value Qx can only be calculated if the measured sO2 a 0 97 The calculation requires entering the sample type as Arterial or Capillary Eq 39 The ODC is determined as described in equation 46 points I and III See the section Oxyhemoglobin dissociation curve ODC further in this chapter 2 S 1 MetHb COHb O 1 COHb MetHb F F s F F where...

Page 250: ...asured after the CO injection Eq 43 3 Anion Gap K Na K Cl HCO c c c c Eq 44 3 HCO Cl Na Gap Anion c c c Eq 45 12 2 2 0 24 7 4 pH Ca 7 4 Ca 10 c c Due to biological variations this equation can only be used for a pH value in the range 7 2 7 6 NOTICE The formula is different from previous Radiometer analyzers The previous formula was an approximation of the current formula The change corresponds to ...

Page 251: ...alue for FHbF has converged Eq 50 8 18 The ODC is determined as described in equations 46 47 in Oxyhemoglobin Dissociation Curve further in this chapter pO2 x is calculated by a numerical method using Eq Description See 50 1 S ODC P A T Eq 47 50 2 2 i 1 MetHb COHb O 1 COHb MetHb S F F s T F F Eq 46 12 50 3 2 i 2 i P O COHb 1 O 1 COHb MetHb p T F s T F F Eq 46 10 50 4 i 2 i 2 2 i t tHb 1 COHb MetHb...

Page 252: ...L90 FLEX reference manual 8 36 The calculation requires entering the sample type as Arterial or Capillary Eq 51 275 6 amb CO air dry CO 2 2 p p V V Eq 52 2 2 O O dry air amb 6 275 p V V p VCO2 V dry air VO2 V dry air ...

Page 253: ...em ln s 1 s vs ln p used in the mathematical model is expressed by equations 46 3 and 46 4 The symbols a and b reflect the ODC displacement from the reference position to its actual position in this coordinate system a describes the displacement at 37 C b the additional displacement due to the patient temperature difference from 37 C The reference position of the ODC was chosen to be the one that ...

Page 254: ...46 8 2 O CO p p M p where M pCO is taken from the Haldane equation 20 2 2 O CO O Hb COHb p p M c c to give eq 46 9 46 9 2 2 2 O COHb O O 1 COHb MetHb p F p p s F F or equation 46 10 46 10 2 2 O COHb 1 O 1 COHb MetHb p p F s F F The ordinate s may loosely be termed the combined oxygen carbon monoxide saturation of hemoglobin and is described by equation 46 11 below Eq Description 46 11 2 2 2 O Hb C...

Page 255: ... a3 a4 a5 46 15 a1 0 88 pH 7 40 46 16 2 CO a2 0 048 ln 5 33 p 46 17 a3 0 7 MetHb F 46 18 a4 0 06 0 02 HbF DPG 5 F c 46 19 a5 0 25 HbF F Step Description I pO2 sO2 can be used If sO2 0 97 the calculation is based on II or III see below Coordinates P0 S0 are calculated from equations 46 9 and 46 11 If FCOHb and FMetHb are not known the default values are used The ODC is shifted from the reference po...

Page 256: ... st of the patient i e the particular patient but at standard conditions The ODC is further shifted as determined by the effect of the measured parameters ac to its actual posi tion This position reflects the p50 act of the patient III sO2 0 97 or erroneous Reference position of the ODC The position of the actual ODC can now be approxi mated from the reference position using the actual values of p...

Page 257: ...presentations of the relationship between saturation S tension P displacement A and temperature T To calculate S or P and to further calculate sO2 and pO2 the other variables should be specified S and P are calculated using numerical methods P is input to equation 46 1 S is input to equation 46 2 A is input to equation 46 5 T is input to equation 46 7 Coordinates on the ODC ...

Page 258: ...using the equations stated below T F o 9 32 5 T C T C o 5 32 9 T F cX meq L cX mmol L where X is K Na or Cl cCa2 meq L 2 cCa2 mmol L or cCa2 mg dL 4 008 cCa2 mmol L cCa2 mmol L 0 5 cCa2 meq L or cCa2 mmol L 0 2495 cCa2 mg dL p mmHg p Torr 7 500638 p kPa p kPa 0 133322 p mmHg 0 133322 p Torr 4 ctHb g dL 1 61140 ctHb mmol L ctHb g L 16 1140 ctHb mmol L or ctHb mmol L 0 62058 ctHb g dL ctHb mmol L 0 ...

Page 259: ... 9 008 cLac mmol L or cLac mmol L 0 11101 cLac mg dL cLac meq L cLac mmol L conversion based on the molecular weight of lactic acid ctBil µmol L 17 1 ctBil mg dL ctBil µmol L 1 71 ctBil mg L or ctBil mg dL 0 0585 ctBil µmol L ctBil mg L 0 585 ctBil µmol L NOTICE All conversions of units are made by the analyzer cGlu cLac ctBil ...

Page 260: ...d in the analyzer if other values are not keyed in T 37 0 C FO2 I 0 21 21 0 RQ 0 86 ctHb 9 3087 mmol L 15 00 g dL or 150 g L FCOHb 0 004 0 4 FMetHb 0 004 0 4 p50 st 3 578 kPa 26 84 mmHg In addition to the above default values the analyzer uses the following default Ambient temperature 25 0 C Values ...

Page 261: ...and multi wavelength hemoximetry reference values precision and accuracy Scand J Clin Lab Invest 1990 50 Suppl 203 57 66 Available as AS106 12 Siggaard Andersen O Thode J Wandrup JH The concentration of free calcium ions in the blood plasma ionized calcium In Siggaard Andersen O ed Proceedings of the IFCC expert panel on pH and blood gases held at Herlev Hospital 1980 Copenhagen Radiometer Medical...

Page 262: ...l laboratory sciences IUPAC IFCC Stage 1 Draft 1 1990 1 361 23 Kokholm G Larsen E Jensen ST ChristiansenTF 3rd ed Blood gas measurements at high altitudes Copenhagen Radiometer Medical A S 1991 Available as AS109 24 Blood gas and pH analysis and related measurements approved guideline NCCLS CLSI document C46 A 2001 25 Burton DR Clinical physiology of acid base and electrolyte disorders 4th ed New ...

Page 263: ...9 Solutions General information 9 2 Solutions 9 3 Certificate of traceability 9 5 ...

Page 264: ...lot number which identifies the solution packs assembled in one production lot All the solutions described in this chapter are for in vitro diagnostic use The expiration date of the solution pack is found on the solution pack barcode label A solution pack can be used on the analyzer for up to 30 days or until no more activities are left but not after the expiration date This means that if you inst...

Page 265: ...ers inorganic salts surfactant metabolites preservatives anti coagulant enzyme and colorant which provide the following substances with approximate concentrations as given below Concentration Substance Unit CAL 1 S1920 CAL 2 S1930 CAL 3 S1940 pH 7 30 6 8 NA pCO2 mmHg 35 NA 80 pO2 mmHg 180 NA NA cNa mmol L 150 70 NA cK mmol L 4 10 NA cCl mmol L 95 50 NA cCa2 mmol L 0 5 2 3 NA cGlu mmol L 0 backgrou...

Page 266: ... 7 NA 1 8 cCl mmol L 105 95 NA 125 cCa2 mmol L 0 8 1 65 NA 0 3 cGlu mmol L 0 15 NA 7 cLac mmol L 0 8 NA 4 ctHb mmol L 0 8 NA 12 sO2 97 NA 70 FO2Hb 92 NA 49 FCOHb 3 NA 20 FMetHb 2 NA 10 FHbF 80 NA 50 ctBil µmol L 0 300 NA 450 NOTICE The actual analyte concentrations for each solution in a solution pack lot are included in the smart chip contained in each solution pack The values are read into the a...

Page 267: ...ABL90 FLEX reference manual 9 Solutions 9 5 Certificate of traceability ...

Page 268: ...9 Solutions ABL90 FLEX reference manual 9 6 ...

Page 269: ...10 1 10 Messages List of analyzer messages 10 2 ...

Page 270: ...ll be logged in the Activity log Do the following Step Action 1 Open the Activity log 2 Find the relevant error 3 Highlight it by touching the screen 4 Press Troubleshoot 5 Follow the procedures given to remedy the error The following table describes possible errors and how to remedy them NOTICE The list contains all possible errors and may thus list errors that will not be relevant for all analyz...

Page 271: ...low the user defined critical limit This is only a message not an error No action required 86 Value above critical limit The parameter value is above the user defined critical limit This is only a message not an error No action required 89 Measured QC value above control range The measured parameter value is above the control range Verify the procedure and repeat the measurement Refer to the ABL90...

Page 272: ...etup Reboot the analyzer 129 LIS HIS Failed to close connection Messages were queued when the communication channel was closed Results and other messages sent by the analyzer to a remote system may be lost If the problem persists check the communication hardware The remote system may lack buffer capacity 131 LIS HIS Failed to send packet A communication error occurred while sending a message The m...

Page 273: ...urement Check Replacement Status for pending replacements Refer to the ABL90 FLEX reference manual for detailed evaluation procedure 202 Westgard Rule 1 3s violation Measured parameter value is outside the mean 3 SD range Verify procedure and repeat measurement Check Replacement Status for pending replacements including electrodes Refer to the ABL90 FLEX reference manual for detailed evaluation pr...

Page 274: ...he Calibration Status and perform any pending calibrations 208 Quality control schedule reminder s present One or more scheduled QC measurements are overdue Check the Quality Control Status and perform the pending quality control 209 Replacement schedule reminder s present One or more scheduled replacements are overdue Check the Replacement Status and perform any pending replacement actions 210 Ca...

Page 275: ...ted FSHb is greater than 10 Measurement accuracy is affected Repeat the measurement 292 Turbidity too high Turbidity is greater than 5 too high for reliable measurements Hyperlipemic sample decrease the lipemic content by e g centrifuge or extraction Perform the measurement on a blood sample from a healthy donor Contact Radiometer service representative 293 Oxi compensated for HbF OXI parameters h...

Page 276: ...ameter Check for and remedy any system messages Repeat the calibration Check solution pack status and replace if necessary Check sensor cassette status and replace if necessary Removal condition Successful calibration 376 Calibration Drift 1 out of range The Drift 1 value exceeds the tolerance Check for and remedy any system messages Repeat the calibration Check solution pack status and replace if...

Page 277: ...essful calibration 443 Ca 7 4 not usable cCa2 at a pH of 7 4 is not usable as the actual pH is outside the 7 2 7 6 range No action required 452 Interference during measurement Interference was detected during measurement Check the patient record for medication containing possible interfering substances 484 Today is last day in stat month remember to print QC statistics After the current day qualit...

Page 278: ...mperature error to disappear Shield analyzer from direct sunlight or heat sources Contact Radiometer service representative 521 Inhomogeneous sample Air bubbles were detected in the sample Results may have Repeat the measurement 522 Calibration error One or more calibration values are erroneous Check for and remedy any system messages Repeat the calibration Check solution pack status and replace i...

Page 279: ...deviates from the expected blood or QC spectrum Measurement may be unreliable Check the patient record for medication containing possible interfering substances Start a calibration Contact Radiometer service representative 582 tHb calibration cuvette factor outside limits tHb calibration failed Perform a calibration Repeat the tHb calibration Contact Radiometer service representative Removal condi...

Page 280: ...meter Parameter measurement values are reported as Perform a calibration Removal condition Successful calibration 608 Cal expired pCO2 Too long time passed since the last successful calibration of the parameter Parameter measurement values are reported as Perform a calibration Removal condition Successful 2 point calibration 609 Cal expired pO2 Too long time passed since the last successful calibr...

Page 281: ...ported as Perform a calibration Removal condition Successful 1 or 2 point calibration 641 ABL DMS PC restarted The analyzer was restarted from power off No action required For information only 642 ABL DMS PC connected to wet section Added by DMS PC when connection to the wet section is obtained No action required 643 ABL DMS PC disconnected from wet section The connection from the DMS PC to the we...

Page 282: ...Hb is too low sO2 is not calculated If Oxi derivates are wanted elevate tHb and or sO2 692 ABL not connected to RADIANCE The analyzer is not connected to RADIANCE Contact your RADIANCE IT engineer Check RADIANCE Communication Setup including TCP IP address port no and password Check that RADIANCE is responding Check network connections Removal condition RADIANCE connection established or disabled ...

Page 283: ...asurement is repeated twice The scheduled QC measurement was not accepted the measurement was repeated twice as requested in the Setup program Corrective Actions No action required 707 Replacement s overdue by 10 Analyzer locked Replacement is overdue by 10 corrective action Lock analyzer was selected in the Setup program Corrective Actions When the analyzer is locked scheduled calibrations are pe...

Page 284: ...er has been refused connection to RADIANCE because the ABL StatLink version is higher than the RADIANCE StatLink version Contact RADIANCE IT engineer or Radiometer service representative Removal condition RADIANCE connection established 768 ABL not connected to RADIANCE ABL StatLink version too low The analyzer has been refused connection to RADIANCE because the ABL StatLink version is lower than ...

Page 285: ...red in the RADIANCE Connection Setup No action required For information only 783 Automatic backup started Automatic backup selected in Disk Functions Setup has started No action required For information only 785 Automatic archiving started Automatic archiving selected in Disk Functions Setup has started No action required For information only 786 Automatic archiving completed Automatic archiving s...

Page 286: ...ator 814 Na locked The parameter has been locked by a RADIANCE operator as reflected in the Activity Log When a parameter is locked presumably due to problems with QC the parameter is repressed in patient results Await corrective actions initiated by the RADIANCE operator Removal condition Determined by the RADIANCE operator 815 Cl locked The parameter has been locked by a RADIANCE operator as ref...

Page 287: ...tor 822 COHb locked The parameter has been locked by a RADIANCE operator as reflected in the Activity Log When a parameter is locked presumably due to problems with QC the parameter is repressed in patient results Await corrective actions initiated by the RADIANCE operator Removal condition Determined by the RADIANCE operator 823 HHb locked The parameter has been locked by a RADIANCE operator as r...

Page 288: ...previously locked parameter has been unlocked No action required For information only 833 pO2 unlocked The message is used in the Activity Log to indicate that a previously locked parameter has been unlocked No action required For information only 834 K unlocked The message is used in the Activity Log to indicate that a previously locked parameter has been unlocked No action required For informati...

Page 289: ... Log to indicate that a previously locked parameter has been unlocked No action required For information only 847 HbF unlocked The message is used in the Activity Log to indicate that a previously locked parameter has been unlocked No action required For information only 848 tBil unlocked The message is used in the Activity Log to indicate that a previously locked parameter has been unlocked No ac...

Page 290: ...aced A new sensor cassette should preferably be conditioned now Start conditioning a new sensor cassette 973 Printer paper must be replaced No more paper in printer Insert new printer paper 978 Flow selector calibration error Shown in the Activity Log when User intervention required has been entered due to this reason The analyzer will automatically enter User intervention required Follow the inst...

Page 291: ... be shown on a result if unable to calculate oxygen due to an unexpected system error Restart the analyzer Perform a calibration Contact Radiometer service representative 1002 pO2 dark data is out of range Can be shown on a result if unable to calculate oxygen due to an unexpected system error Restart the analyzer Perform a calibration Contact Radiometer service representative 1004 Unable to calcu...

Page 292: ...ervice representative 1013 Oxi data collection error Oxi hardware error Restart the analyzer Perform a calibration Contact Radiometer service representative 1014 Oxi Blank Cal intensity too high The spectrometer received too high light intensity during Blank Cal Check solution pack During Oxi Blank calibration the cuvette must be filled with liquid Perform a calibration Restart the analyzer Contac...

Page 293: ...e problem Restart the analyzer Contact Radiometer service representative 1023 Oxi spectrometer memory read problem Oxi hardware problem Restart the analyzer Contact Radiometer service representative 1024 Oxi spectrometer memory write problem Oxi hardware problem Restart the analyzer Contact Radiometer service representative 1025 Oxi hemolyzer tuning problem Oxi hardware problem Restart the analyze...

Page 294: ...ll the solution pack and sensor cassette Restart the analyzer Contact Radiometer service representative 1061 Pressure test flow error The sample transport through the analyzer is hindered The analyzer will automatically enter User intervention required Follow the instructions shown on the screen 1062 Pressure test pressure error A leak has been found in the solution transport The analyzer will aut...

Page 295: ...tart wait for the error to disappear Replace the fan filter if dirty Shield the analyzer from direct sunlight and other heat sources Contact Radiometer service representative 1069 Temperature in Oxi cuvette out of range Hardware temperature error Ensure that the ambient temperature is between 15 and 32 C If the system has just performed a cold start wait for the error to disappear Replace the fan ...

Page 296: ... enter User intervention required Follow the instructions shown on the screen 1085 Inhomogeneous QC1 solution Bubbles were detected in the QC1 solution Perform a refill from the auxiliary program Replace the solution pack 1086 Inhomogeneous QC2 solution Bubbles were detected in the QC2 solution Perform a refill from the auxiliary program Replace the solution pack 1087 Inhomogeneous QC3 solution Bu...

Page 297: ...ctions shown on the screen 1098 No gas Shown in the Activity Log when User intervention required has been entered due to this reason The analyzer will automatically enter User intervention required Follow the instructions shown on the screen 1099 Pump calibration error Shown in the Activity Log when User intervention required has been entered due to this reason The analyzer will automatically ente...

Page 298: ...or keep alive timeout Internal communication error Restart the analyzer Contact Radiometer service representative 1117 Oxi spectrometer temperature drift A large deviation in temperature has been observed This is probably due to a change in the ambient environment Perform a calibration 1120 Sensor replacement successful This message is shown in the Activity Log following a successful replacement o...

Page 299: ...entative 1135 The solution pack has been used before This message is shown in the Activity Log after a failed solution pack replacement Reinstall the solution pack 1140 The solution pack has used the maximum number of measurements at installation This message is shown in the Activity Log after a failed solution pack replacement Reinstall the solution pack 1142 The printer door is open Printing not...

Page 300: ...due to inlet being closed before aspiration could be completed No action required For information only 1151 Inlet not closed no sample aspirated This message is shown in the Activity Log when a measurement has been cancelled due to inlet being closed too late No action required For information only 1152 The solution pack chip data could not be read or written during replacement This message is sho...

Page 301: ...ervention required has been entered due to this reason The analyzer will automatically enter User intervention required Follow the instructions shown on the screen 1171 Inlet is missing or in unknown state Shown in the Activity Log when User intervention required has been entered due to this reason The analyzer will automatically enter User intervention required Follow the instructions shown on th...

Page 302: ...cally enter User intervention required Follow the instructions shown on the screen 1178 A pump calibration error was detected Shown on screen when User intervention required has been entered due to this reason The analyzer will automatically enter User intervention required Follow the instructions shown on the screen 1180 An error occurred when trying to communicate with wet section Shown in the A...

Page 303: ...n in the Activity Log when User intervention required has been entered due to this reason The analyzer will automatically enter User intervention required Follow the instructions shown on the screen 1190 Inlet open Shown in the Activity Log when User intervention required has been entered due to this reason The analyzer will automatically enter User intervention required Follow the instructions sh...

Page 304: ...lution pack empty Shown in the Activity Log when User intervention required has been entered due to this reason The analyzer will automatically enter User intervention required Follow the instructions shown on the screen 1201 Solution pack lifetime expired Shown in the Activity Log when User intervention required has been entered due to this reason The analyzer will automatically enter User interv...

Page 305: ... Follow the instructions shown on the screen 1219 RiLiBÄK Violation Value above upper limit The measured value lies above the upper RiLiBÄK range No action required 1220 RiLiBÄK Violation Value below lower limit The measured value lies below the lower RiLiBÄK range No action required 1221 System temperature out of range Hardware temperature error all Ensure that the ambient temperature is between ...

Page 306: ... Chloride is corrected for bicarbonate calculated from pH and pCO2 Errors from pH pCO2 results in this error on chloride No action required 1228 Correction for lactate contains errors from K Na Ca2 Lactate is corrected for ion strength calculated from K Na Ca2 Errors from K Na Ca2 results in this error on lactate No action required 1230 Inlet gasket replaced Shown in the activity log at the time o...

Page 307: ...ctivity has been repeated The following entries in the log explain the reason for the repeat No action required 1303 Activity repeated An activity has been repeated The following entries in the log explain the reason for the repeat No action required 1304 Calibration activity repeated A calibration activity has been repeated The following entries in the log explain the reason for the repeat No act...

Page 308: ... Cal backlog error pCO2 Backlog unstable leaping signals on rinse Perform rinse 1317 Cal backlog error pO2 Backlog unstable leaping signals on rinse Perform rinse 1318 Cal backlog error K Backlog unstable leaping signals on rinse Perform rinse 1319 Cal backlog error Na Backlog unstable leaping signals on rinse Perform rinse 1320 Cal backlog error Ca Backlog unstable leaping signals on rinse Perfor...

Page 309: ...d entered The analyzer enters UIR No action required 1332 Intervention required exited The analyzer exits UIR No action required 1333 Sensor conditioning started no BC Sensor conditioning started no barcode was scanned No action required 1334 Sensor conditioning started BC Sensor conditioning started a valid barcode was scanned No action required 1335 Solution pack replaced This message is used in...

Page 310: ...10 Troubleshooting updated for software version 2 3 ABL90 FLEX reference manual 10 42 ...

Page 311: ... Statistical parameters I 3 Control ranges for manual QC only I 4 User control ranges for manual QC only I 6 Statistics factor and statistics range I 9 Temperature corrections for manual QC only I 10 Westgard rules I 12 Quality control evaluation I 15 ...

Page 312: ...relevant and in some case also specific for the ABL90 FLEX analyzer Some of the sections in this appendix contain information about both built in and manual quality controls Most of the information in this appendix is however only relevant for manual quality control and the appendix is therefore first and foremost thought as a supplement to the manual quality controls ...

Page 313: ...stribution about the mean value and is calculated as follows 1 n X X SD 1 2 and can be illustrated on the normal distribution curve 1 SD includes 68 3 of the results 2 SD includes 95 5 of the results and is normally used for clinical instruments Coefficient of variation CV Coefficient of variation expresses the variation in the sampling results and is calculated as follows 100 X SD CV where SD sta...

Page 314: ...ferently and control ranges must be established separately for each type of analyzer The width of the control ranges is determined during the development phase by measuring on a number of analyzers The measurements are performed by different persons over several days using different dispensers and with different lot numbers of calibration solutions all this to ensure that all natural variations su...

Page 315: ...should fall with at least 95 probability The insert control ranges are established by being centered around each parameter s assigned value The width of the insert control ranges is determined using an uncertainty budget comprising contributions from the analyzer the calibration solutions and the QCs The uncertainty budget guarantees that only relevant contributions to the width of the insert cont...

Page 316: ...s and inhomogeneity of the QC lot should be included in the user defined control ranges see procedure further in this chapter The following requirements should be fulfilled for analyzer specific control ranges The established mean value falls within the insert control ranges Worldwide DATACHECK participants the established SD is not wider than 1 26 x Avg SD of the peer group of similar analyzers T...

Page 317: ... 2 corrected total SD 2 SD 2 SD 4 Determine the user defined control ranges as corrected X SD 5 Enter the user defined control ranges for each parameter in the Control Ranges setup program press Menu Utilities Setup QC Setup Control Ranges Edit SDtotal for QUALICHECK5 solutions Level 1 Parameter ABL90 FLEX analyzer pH 0 0041 pCO2 kPa 0 14 pO2 kPa 0 31 cK mmol L 0 035 cNa mmol L 0 7 cCa2 mmol L 0 0...

Page 318: ... ABL90 FLEX analyzer pH 0 0074 pCO2 kPa 0 07 pO2 kPa 0 44 cK mmol L 0 036 cNa mmol L 0 6 cCa2 mmol L 0 019 cCl mmol L 1 08 cGlu mmol L 0 4 cLac mmol L 0 2 ctBil mol L 4 1 ctHb g dL 0 18 FHbF 2 6 Other Hb derivatives 0 19 Level 4 Parameter ABL90 FLEX analyzer pH 0 0046 pCO2 kPa 0 26 pO2 kPa 0 73 cK mmol L 0 055 cNa mmol L 0 5 cCa2 mmol L 0 023 cCl mmol L 0 95 cGlu mmol L 0 1 cLac mmol L 0 1 ctBil m...

Page 319: ... narrow over time Using the recommended statistics factor of 1 5 will have the following effect User control ranges 2 SD The statistics range will correspond to X 3 SD Insert control ranges The statistics range will correspond to 1 5 insert control range All results outside the statistics range will be excluded from the statistics and marked accordingly The control range is pH low 6 986 and pH hig...

Page 320: ...ault temperature of a QC measurement is automatically set at 25 C unless otherwise specified by the user If the ampoule temperature is not 25 C the equilibrium will be different The lower the temperature the more O2 and CO2 molecules will migrate to the liquid phase and the pCO2 and pO2 will report too high values and the pH a too low value if the results are not temperature corrected If the tempe...

Page 321: ...H corr to 25 C pH meas A t 25 pCO2 pCO2 corr to 25 C pCO2 meas 1 A t 25 pO2 pO2 corr to 25 C pO2 meas 1 A t 25 where A a temperature constant The values are given in the table below Range QUALICHECK Temperature constants A Level 1 Level 2 pH 0 0013 0 0026 pCO2 0 0056 0 0071 pO2 0 0098 0 0107 NOTICE Temperature fluctuations for S7950 level 3 are negligible so that no temperature corrections are req...

Page 322: ...ugh modification of control ranges They are best expressed in the form of plots Westgard rules are divided into two types Westgard rule types Explanation Warning rules Indicate that the next measurement should be treated with care as the previous measurement was outside the established ranges It is recommended to perform a second measurement on a new ampoule of the same level Rule 12s is the only ...

Page 323: ...ion rule Measurement value is outside the mean 3 SD Corrective action Perform another measurement on a new ampoule of the same level If the second result falls within the control range then the first result can be attributed to normal statistical variation If the second result is outside the established mean 2 SD see section Quality control evaluation further in this appendix This rule is applicab...

Page 324: ...the mean 1 SD on the same side of the mean This indicates a trend or shift Corrective action Perform steps described in section Quality control evaluation further in this appendix This rule is only applicable to manual QC and is only recommended when user defined control ranges are established This rule is a rejection rule 10 consecutive measurements on the same side of the mean This indicates a t...

Page 325: ...id you condition the ampoules according to the specifications 3 Did you key in the correct ampoule conditioning temperature 4 Did you shake the ampoule vigorously for 15 seconds before using it 5 Did you remember to hold the ampoule between your thumb and index finger when you shook it This is done to avoid heating up the ampoule contents and thus change its temperature 6 Did you analyze control s...

Page 326: ...Appendix Quality control ABL90 FLEX reference manual I 16 ...

Page 327: ...II Appendix Traceability to the primary standards at Radiometer ...

Page 328: ...anual II 2 Introduction The Metrology Section at Radiometer is responsible for establishing metrological traceability for the parameters pH pCO2 pO2 cK cNa cCa2 cCl cGlu cLac sO2 FCOHb FMetHb FHbF Hct ctBil and ctHb This booklet documents the traceability for each of these parameters ...

Page 329: ...d are 1674b 2625a 2658a and 2659a The NIST SRM gases are used to validate primary gravimetric working gas standards certified by Scott Medical Air Liquide or Air Products The primary gravimetric working gas standards are validated using a computer controlled gas chromatography system introducing the NIST SRM gases as samples and comparing the obtained results with the certified values The primary ...

Page 330: ...primary standards are used to determine the glucose concentration of secondary standards The measurements take place using the glucose reference method which is the hexokinase glucose 6 phosphate dehydrogenase method recommended by CLSI This method is described in Ref 3 No certified standard reference material for lactate is available at present The primary working standards are therefore prepared...

Page 331: ...condary standard and is used to calibrate the ABL735 reference instruments The primary working standard used is a whole blood sample The blood sample is tonometered with 100 CO with a certified purity of 99 997 CO The primary working standard is used to calibrate the ABL735 reference instruments The primary working standard is a whole blood sample The FMetHb is determined using the KCN addition me...

Page 332: ...rifugation time has been 5 minutes The conductivity and sodium concentration has been measured on approximately 1000 blood samples with a sodium concentration varying from 80 mmol L to 180 mmol L Hct measurements have then been correlated to the Hct measured by the reference method The primary working standard is a whole blood sample The total bilirubin is determined on a serum sample prepared fro...

Page 333: ...on of carbon monoxide in blood by gas chromatography Clin Chem 1968 14 2 162 71 7 Evelyn KA Malloy HT Microdetermination of oxyhemoglobin methemoglobin and sulfhemoglobin in a single sample of blood J Biol Chem 1938 126 655 62 8 Kristoffersen K An improved method for the estimation of small quantities of alkali resistant hemoglobin in blood Scand J Clin Lab Invest 1961 13 402 9 Tan GB Aw TC Dunsta...

Page 334: ...Appendix Traceability to the primary standards at Radiometer ABL90 FLEX reference manual II 8 ...

Page 335: ...urity 1 4 access profiles 1 8 general security 1 4 operators and password 1 5 Analyzer settings 1 47 acoustic signal 1 49 analyzer identification 1 47 barometer setup 1 50 languages 1 51 time and date setup 1 48 Anticoagulants sampling 7 28 Archives deleting 2 8 export 2 8 import 2 8 Automatic archiving 1 60 Automatic archiving setup 1 60 Automatic backup setup 1 62 Automatic data request setup 1 ...

Page 336: ... and corrective actions 1 65 Confidence intervals 7 5 Construction metabolite sensors 5 33 optical system 5 39 pCO2 sensor 5 23 pH and electrolyte sensors 5 17 reference electrode 5 15 Contents of setup settings 1 79 Continuous spectrum 5 41 Control ranges definitions I 4 Conversion activity to concentration 5 3 Conversion units 8 42 Corrections pCO2 sensor 5 28 pO2 sensor 5 31 user defined 6 1 Co...

Page 337: ...s 8 4 8 15 acid base 8 15 numerical format 8 19 oximetry 8 16 oxygen 8 16 units 8 19 Detecting HbF 5 45 Determining concentrations 5 42 Disabled versus deselected parameter 1 11 Disk functions 2 1 Disk functions programs 2 2 Disk functions setup 1 60 Disk handling rules 2 2 Disk storage options 2 2 Display unit 4 4 E Editing a user activity 1 38 a user defined Note 1 46 parameter setup 1 42 the QC...

Page 338: ...ties 1 82 barcode reader 1 83 keyboard 1 82 mouse 1 82 network 1 82 Interference correcting for 5 45 Interference tests metabolites 7 23 L Lambert Beer s law 5 40 Languages 1 51 LIS HIS connection setup 1 53 List of equations 8 23 Loading setup 2 10 Lot 9 2 M Maintenance planning 1 39 Manual QC symbols in QC schedule 1 24 Manual quality control QC solutions 1 23 Material safety data sheets 9 2 Mat...

Page 339: ...ined 1 46 O ODC 8 37 actual position 8 39 coordinates 8 41 determining actual displacement 8 39 displacement 8 38 equations 8 37 reference position 8 37 Operators and passwords 1 5 Optical pO2 5 3 Optical system calibration 5 44 construction 5 39 measured parameters 5 39 measurement cycle 5 40 Oximetry derived parameters 8 16 Oximetry parameters 5 47 8 19 Oximetry system electronics 4 3 Oxygen der...

Page 340: ...t results cCa2 7 11 Performance test results cCl 7 10 Performance test results cGlu 7 11 Performance test results cK 7 9 Performance test results cLac 7 12 Performance test results cNa 7 10 Performance test results ctHb 7 13 Performance test results FCOHb 7 15 Performance test results FHbF 7 17 Performance test results FHHb 7 17 Performance test results FMetHb 7 16 Performance test results FO2Hb 7...

Page 341: ...setup 1 23 Quality Management 5 9 R RADIANCE connection setup 1 52 Radiometer default setup access 1 70 Recommended replacement intervals 1 36 Reference electrode 5 13 background information 5 14 construction 5 15 Reference ranges and critical limits 1 12 Replacement intervals 1 36 Replacement schedule setup 1 35 Replacement setup 1 35 replacement intervals recommended 1 36 user activities adding ...

Page 342: ...matic backup setup 1 62 automatic data request setup 1 57 automatic data transmission setup 1 55 automatic printing 1 64 barometer 1 50 calibration schedule 1 22 communications 1 52 corrective actions 1 65 critical limits 1 12 default settings 1 70 disk functions 1 60 2 1 general security 1 4 languages 1 51 LIS HIS connection setup 1 53 loading 2 10 maintenance planning 1 39 manual quality control...

Page 343: ...al safety data sheets 9 2 pouch volume 9 3 solution pack 9 2 use 9 3 Spectrophotometry 5 3 Spectrum examples 5 42 spectrum repression 5 45 Statistical parameters I 3 Statistics Factor and Statistics Range I 9 Status 5 30 Storage 9 2 Symbols for manual and built in QC 1 24 Symbols parameters 8 3 Syringe modes 1 10 System check 5 9 T Temperature corrections manual QC only I 10 Test conditions 7 6 tH...

Page 344: ...t 6 4 User defined notes 1 46 adding 1 46 deleting 1 46 editing 1 46 User defined patient data items 1 44 editing 1 44 V Values default values 8 44 W Waste removal 3 4 WDC creating report 2 3 Westgard rules 1 30 activating 1 31 I 12 rule R4s I 14 rule 10x I 14 rule 12s I 13 rule 13s I 13 rule 22s I 13 rule 41s I 14 selecting deselecting 1 31 Wet section contents 3 2 diagram 3 3 Wet section control...

Page 345: ...ufacturer ABL90 FLEX reference manual from software version 2 3 Publication 201006 Edition D Code number 994 527 Radiometer Medical ApS Åkandevej 21 2700 Brønshøj Denmark www radiometer com If you have any questions or need assistance please contact your local Radiometer representative ...

Page 346: ...Date of issue ABL90 FLEX reference manual ...

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