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ABL90 FLEX reference manual

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Summary of Contents for RADIOMETER ABL90 FLEX

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ABL90 FLEX reference manual…
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ABL90 FLEX reference manual…
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Note to the users of the ABL90 FLEX analyzer Introduction This note to users outlines the most significant changes and improvements of software version 2.4 in the English version of the ABL90 FLEX reference manual (994-527). Brief overview Changes/Description of the change…
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CHAPTER 10: Conditioning in As a manual conditioning of the sensor cassette pack is not sensor cassette pack possible for the time being, references to this option are no longer not possible valid and, therefore, the following analyzer messages no longer exist in software version 2.4: Sensor conditioning due 1080…
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Table of contents ABL90 FLEX Setup Disk functions setup programs Wet section Electronics Sensors and measuring technologies User-defined corrections Reference Performance characteristics manual Parameters From software version 2.3 Solutions 10. Analyzer messages I Appendix – Quality control II Appendix – Traceability to primary…
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Radiometer are used. Radiometer warrants that the data media on which the software included in the system is furnished is free from defects in material and workmanship under normal use for three (3) months from the date of delivery as evidenced by a copy of invoice or receipt.
Page 9: Table Of Contents

ABL90 FLEX reference manual Contents Contents 1. Setup ………………..1-1 Setup menu structure ……………. 1-3 Analyzer security …………….1-4 Programs……………… 1-4 General security ……………. 1-4 Operators and passwords…………1-5 Access profiles …………….1-8 Analysis setup ……………..1-10 Program ………………1-10 Syringe/capillary modes…………..1-10 Setting up a new measuring mode ……….1-11…
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Contents ABL90 FLEX reference manual User activities…………….1-37 Adding a user activity…………..1-37 Editing a user activity…………..1-38 Deleting a user activity …………..1-38 Maintenance planning …………..1-39 Replacement warnings …………..1-40 Parameters and input setup ……………1-41 Program ………………1-41 Parameter setup …………….1-41 Units setup ……………..1-43 User-defined patient data items ………….1-44 User-defined notes ……………1-46…
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ABL90 FLEX reference manual Contents Access to Radiometer default setup ……….1-70 Operators and passwords…………1-70 Analysis setup …………….1-71 Calibration schedule …………..1-72 Quality control setup …………..1-72 Replacement setup …………..1-73 General setup …………….1-73 Setups without Radiometer settings ……….1-77 Print setup ………………1-78 Contents of setup settings …………..1-79 Groups of setup settings …………1-79…
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Contents ABL90 FLEX reference manual Prior to measurement…………..3-4 Heating ………………3-4 Solutions ……………… 3-4 Waste removal …………….3-4 Patient samples …………….3-5 Measuring process …………..3-5 Rinse process ………………. 3-6 Calibration ………………3-7 calibration …………….3-7 , cGlu, cLac calibration …………3-7 –…
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ABL90 FLEX reference manual Contents Sample measurements …………… 5-8 Corrections …………….5-8 Quality Management…………….5-9 Introduction…………….5-9 System/ analysis checks …………. 5-9 Calibration …………….5-12 Measurement …………….5-12 Reference electrode…………….5-13 Background information about the reference electrode ……5-14 Purpose……………….5-14 Fixed potential ……………..5-14 Use………………5-14 Construction of the reference electrode ……….5-15…
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Contents ABL90 FLEX reference manual Measuring sequence…………..5-29 Calculations …………….5-29 Calibration of the pO sensor ………….5-30 Introduction…………….5-30 Sensitivity …………….5-30 Status………………5-30 Measurement — pO …………….5-31 Checks ………………5-31 Metabolite sensors …………….5-32 Construction of the metabolite sensors……….5-33 Basic description……………5-33 Diagram ………………5-33 Parts and description…………..5-33 Zero current …………….5-33…
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ABL90 FLEX reference manual Contents General information…………….6-2 Purpose of use …………….6-2 User-defined corrections …………. 6-2 Preparatory action …………..6-2 Entering user-defined corrections ……….6-3 Correction factors for pH and blood gases ……….6-4 Correcting slope and offset…………6-4 Correction factors for oximetry parameters ………..
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Contents ABL90 FLEX reference manual Bias ……………..7-11 Prim.ref Bias and Repeatability – blood samples ………7-11 Sec.ref Performance test results – cGlu…………7-11 Reference method…………..7-11 Bias and Repeatability – blood samples………7-11 Prim.ref Performance test results – cLac…………7-12 Reference method…………..7-12 Bias and Repeatability – blood samples………7-12 Prim.ref…
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ABL90 FLEX reference manual Contents Measured parameters ……………. 8-6 General information …………..8-6 pH ………………. 8-6 ………………8-6 ………………8-6 ………………8-7 Baro ………………8-7 ctHb ………………8-7 ………………8-8 Hb ………………8-8 FCOHb ………………8-8 FMetHb ………………8-8 FHHb ………………8-9 FHbF………………
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Contents ABL90 FLEX reference manual (A) ………………8-26 (A,T)………………8-26 (a)/FO (I)…………….8-26 (a,T)/ FO (I) ……………8-27 p50 ………………8-27 p50(T) ………………8-27 p50(st) ……………….8-28 (A-a) ……………..8-28 (A-a,T)…………….8-28 (a/A) ……………..8-28 (a/A,T)…………….8-28 (or p )………………8-29 ………………8-29 – (av ) …………….8-29 ………………8-29 (x) (or c ) …………….8-30 ·…
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……………… I-14 ………………I-14 Rule 10 ……………… I-14 Quality control evaluation…………..I-15 Evaluation procedure…………..I-15 II Appendix — Traceability to the primary standards at Radiometer …II-1 Introduction ………………II-2 Traceability ………………II-3 pH ………………. II-3 and pO …………….II-3 and cNa …………….
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Contents ABL90 FLEX reference manual cLac………………II-4 ctHb ………………II-4 Saturation – sO = 100 %…………II-5 Saturation – sO = 0 % ………….. II-5 FCOHb – normal value…………..II-5 FCOHb – 100 %……………. II-5 FMetHb ………………II-5 FHbF………………II-5 Hct ………………
Page 21: Setup

1. Setup Setup menu structure …………..1-3 Analyzer security…………….1-4 Analysis setup…………….1-10 Syringe modes …………….1-10 Reference ranges and critical limits……….1-12 Reportable ranges……………..1-15 Patient report setup …………..1-16 Sample pre-registration setup…………1-20 Sample age evaluation setup …………1-21 Calibration schedule setup ……………1-22 Quality control setup……………1-23 Manual quality control (QC) solutions ……….1-23 Quality control schedule setup …………1-24 QC ranges………………1-26…
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1. Setup ABL90 FLEX reference manual Automatic data request setup …………1-57 Patient lookup setup…………..1-58 QA Portal connection setup………….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…
Page 23: Setup Menu Structure

ABL90 FLEX reference manual 1. Setup Setup menu structure Menu Utilities Setup Analysis setup QC setup Syringe modes QC solutions Capillary modes QC schedule Patient reports QC ranges Reference ranges QC input setup Sample age evaluation QC statistics setup Westgard Rules Reportable ranges RiLiBÄK ranges…
Page 24: Analyzer Security

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.
Page 25: Operators And Passwords

123456, and enter the actual users with their profiles and passwords. Radiometer All menu items and programs (user and service) on the analyzer. Note that «Radiometer» cannot be removed from the operator list. Remote operator All menu items and programs (user and service) on the…
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1. Setup ABL90 FLEX reference manual To add an operator to the list, do the following: Step Action Press the Add Operator button to display the Add New Operator screen. Type the name of the operator or operator category in the «Operator ID»…
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ABL90 FLEX reference manual 1. Setup To edit the operator identifications of an operator, do the following: Step Action Press the Edit Operator button to display the Add New Operator screen. Touch and highlight the box to be changed. Enter the change. If you change the passwords, confirm them again.
Page 28: Access Profiles

1. Setup ABL90 FLEX reference manual This program allows you to define the permitted actions, the available menu Access profiles items and button shortcuts of an access profile. To enter this program, press Menu > Utilities > Setup > Analyzer Security >…
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ABL90 FLEX reference manual 1. Setup The buttons allows you to do the following: Highlight menu items Open/close submenus Select/deselect a menu item To create a button shortcut for a specific item, highlight the desired item in the «Menu Items in Quick Menu» box and then, in the «Button configuration»…
Page 30: Analysis Setup

1. Setup ABL90 FLEX reference manual Analysis setup Program Press Menu> Utilities > Setup > Analysis setup and activate a button to enter a program. The following programs are available:  Syringe mode  Capillary mode  Patient reports  Reference ranges …
Page 31: Setting Up A New Measuring Mode

You can further select or deselect a parameter before or after a measurement  see chapter 4: Sample measurement in the ABL90 FLEX operator’s manual. Editing name Step…
Page 32: Selecting A Default Layout

1. Setup ABL90 FLEX reference manual Selecting a Step Action default layout Press Layout on one of the Modes setup screens. Select the layout from the list (made in the Patient report setup – see Patient report setup further in this section).
Page 33: Setting Age Group Limits

ABL90 FLEX reference manual 1. Setup Setting age group limits 0 days-1 month, 1-5 months, 5-8 months, >8 months» Step Action Press the Age groups button on the Reference ranges and critical limits screen. Use the following to set/change the age groups: …
Page 34: Setting Reference And Critical Limits For Each Parameter

1. Setup ABL90 FLEX reference manual Setting reference and critical limits for each parameter Step Action Highlight a parameter on the Reference ranges and critical limits screen, using the up/down arrows. Enter sample type, sex and age group, if required.
Page 35: Reportable Ranges

 A reportable range must be smaller than or equal to the range of indication  Measured parameters show the reportable ranges. Derived parameters show «..»  See also Calibration verification, chapter 6 in the ABL90 FLEX operator’s manual. 1-15…
Page 36: Patient Report Setup

Preview. This test print will be labeled «Preview». To delete a highlighted layout, press Delete. Note that the Radiometer default layout cannot be deleted. The button is disabled if only the Radiometer default layout is available. 1-16…
Page 37: Editing A Layout

ABL90 FLEX reference manual 1. Setup Editing a layout Step Action Highlight a layout in the list by touching it on the screen. Press Edit patient ID layout to edit the patient ID items or press Edit patient results layout to edit the parameter groups – see the description further in this section.
Page 38: Default Values

1. Setup ABL90 FLEX reference manual Default values Changes to List Step Action Highlight the desired item in the «Selected items» box with the arrow buttons. Set the default:  If the item has a value, press Keyboard, enter the value and press Enter on the keyboard to confirm …
Page 39: Editing Patient Result Layout

ABL90 FLEX reference manual 1. Setup Editing patient result layout Step Action Highlight a patient report layout on the Patient report setup screen and press Edit patient results layout.  Add a highlighted item in the «Available items» box to the list of…
Page 40: Sample Pre-Registration Setup

1. Setup ABL90 FLEX reference manual Sample pre-registration setup This program allows you to select interpretation of the barcode and the patient data that can be confirmed before and during a sample measurement. Press Menu > Utilities > Setup > Analysis setup > Sample pre- registration to access the program.
Page 41: Sample Age Evaluation Setup

ABL90 FLEX reference manual 1. Setup Sample age evaluation setup This program allows you to set up a maximum sample age for the individual parameters to enable an automatical sample age evaluation. Press Menu > Utilities > Setup > Analysis setup > Sample age evaluation setup.
Page 42: Calibration Schedule Setup

1. Setup ABL90 FLEX reference manual Calibration schedule setup Program Press Menu > Utilities > Setup > Calibration schedule to access the Calibration schedule setup program. In the program you can do the following:  Set the time for the first calibration each day. This is only an option, and if the time is not set, the first calibration will by default start at 00:00 (12 midnight).
Page 43: Quality Control Setup

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-Radiometer control solutions: press Add Non-R-. To delete a control solution, highlight the desired slot and press Delete to cancel the operation.
Page 44: Quality Control Schedule Setup

1. Setup ABL90 FLEX reference manual CAUTION – Changing QC Changing a QC assigned to a slot will delete all current QC statistics obtained on that slot. If you want a copy of the statistics for the last QC month, create a WDC Report disk – see chapter 2: Disk functions setup programs.
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ABL90 FLEX reference manual 1. Setup Adding a new QC solution to a schedule: Step Action Select the desired time and press Add to display the screen above. Touch the «QC slot» box to activate it, if not already activated.
Page 46: Qc Ranges

1. Setup ABL90 FLEX reference manual Editing the QC schedule: Press Edit and follow the procedure above. Deleting items from the QC schedule: Step Action Highlight the desired item (i.e. QC measurement) and press Delete. Press Event for this day, Event for all days or All entries for QC slot to remove the QC measurement from the schedule.
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ABL90 FLEX reference manual 1. Setup Step Action Press Next slot to display the desired slot and then press Edit. Select the parameter to be edited, using Next param. or Prev param. Press Update to change the range to the one shown in the «Lot to Date range (2 SD)»…
Page 48: Qc Input Setup

1. Setup ABL90 FLEX reference manual Updating control ranges for all parameters of the displayed level: Step Action Display the desired slot, using Next slot. Press Update all. Press Continue to update the control ranges for all parameters under the specified slot, or press Cancel to cancel updating.
Page 49: Qc Statistics

ABL90 FLEX reference manual 1. Setup Step Action Activate the Mandatory temperature check button Or highlight the default temperature in the «Default temperature» box, enter a default temperature on the keypad and confirm with Enter. NOTICES:   A will appear next to an empty temperature box on the Quality control identification screen during each QC measurement;…
Page 50: Westgard Rules Setup

1. Setup ABL90 FLEX reference manual Westgard Rules setup In this program you can select Westgard Rules for all slots or for specific parameters. Step Action Select the desired slot, using Next slot. Press On/Off to activate the assigned Westgard Rules for the slot or press this button again to deactivate them.
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ABL90 FLEX reference manual 1. Setup Activating Westgard Rules for a specific parameter: Step Action Display the desired slot, using Next slot and press Edit. Display the desired parameter using Next param or Prev param. Activate the desired Westgard Rule(s) by pressing the corresponding check button.
Page 52: Reference

1. Setup ABL90 FLEX reference manual Press Select All or Deselect all and verify the information on the screen. Press Continue. Changes are made and shown in the Westgard Rules Setup. Press Cancel. No changes are made. NOTICES:  When a QC measurement violates an applied Westgard Rule, a W is added to the parameter in the result.
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ABL90 FLEX reference manual 1. Setup To add a new RiLiBÄK rule, do the following: Step Action Press the Add button to display the screen below: Select the desired parameter from the parameter list shown in the right side of the screen.
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1. Setup ABL90 FLEX reference manual To edit a RiLiBÄK rule, do the following: Step Action Select the desired rule in the RiLiBÄK ranges screen and press Edit to display the screen below: to jump between the input boxes and edit the desired values.
Page 55: Replacement Setup

ABL90 FLEX reference manual 1. Setup Replacement setup Program Press Menu > Utilities > Setup > Replacement setup to access the Replacement setup and activate a button to enter a program. The following programs are available:  Replacement schedule  User activities …
Page 56: Recommended Replacement Intervals

1. Setup ABL90 FLEX reference manual Step Action Highlight the replacement action to be scheduled and press Edit. Change the interval for the selected replacement action (displayed in the «Action» box), using the up/down arrows (see Recommended replacement intervals below).
Page 57: User Activities

ABL90 FLEX reference manual 1. Setup User activities In this program you can formulate and schedule your own activities (e.g. cleaning analyzer, replacing printer paper, etc.) along with the current scheduled date and interval. The settings selected here are then used in the Replacement status.
Page 58: Editing A User Activity

1. Setup ABL90 FLEX reference manual Editing a user Step Action activity Highlight the desired user activity on the User activities screen and press Edit. Press the Keyboard button to edit the text. Confirm the text with Enter. Change, if desired, the interval or next date (confirm the date with Enter).
Page 59: Maintenance Planning

ABL90 FLEX reference manual 1. Setup Maintenance planning In this program you can plan replacements during a week and the shift. Step Action Activate the check buttons for the days on which maintenance is to be performed. Select the time at the beginning or the end of the shift, using the up/down arrows Press Close to confirm the settings.
Page 60: Replacement Warnings

1. Setup ABL90 FLEX reference manual Replacement warnings In this program you can set the time for a warning to appear before a replacement. This will affect the status of the traffic light on the main screen. Step Action Select the number of remaining tests before the warning should be given, using the up/down arrows.
Page 61: Parameters And Input Setup

ABL90 FLEX reference manual 1. Setup Parameters and input setup Program Press Menu > Utilities > Setup > General setup > Parameters and input setup and activate a button to enter a program. The following programs are available:  Parameters …
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1. Setup ABL90 FLEX reference manual Locking/unlocking a parameter: Step Action Ensure that the analyzer is not connected to the RADIANCE system, as parameters can be locked/unlocked from the RADIANCE system. Highlight a parameter on the screen, using the scroll facilities.
Page 63: Units Setup

ABL90 FLEX reference manual 1. Setup Step Action Highlight the desired parameter in the Parameter setup screen and press Edit. Activate (or deactivate) the following check buttons to select (or deselect) the following functions:  Repression (repress parameter value in patient result in case of any problems) …
Page 64: User-Defined Patient Data Items

1. Setup ABL90 FLEX reference manual Step Action Highlight a parameter or a group of parameters, using the arrow buttons. Select the unit, using the arrow buttons, and confirm with Select. Change units for other parameters in a similar manner.
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ABL90 FLEX reference manual 1. Setup Press the Keyboard button on the keypad and type in the new name of up to 20 characters. Confirm with Enter on the keyboard. Select the data type with the up/down arrows and press Select.
Page 66: User-Defined Notes

1. Setup ABL90 FLEX reference manual User-defined notes Press Utilities > Setup > General setup > Parameters and input > User- defined notes. Adding a Note: Step Action Activate one of the check buttons on the screen. Press Add. Type the text for the Note, using the screen keyboard. Confirm with Enter to save the text and return to the previous screen.
Page 67: Analyzer Settings

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 inquiries you may have to Radiometer. 1-47…
Page 68: Time/Date Setup

1. Setup ABL90 FLEX reference manual Time/date setup In this program you can change the current time and date setting. Step Action Highlight the «Time» box by touching it on the screen. Key in the time on the screen keypad. Confirm with Enter.
Page 69: Acoustic Signal Setup

ABL90 FLEX reference manual 1. Setup Acoustic signal setup In this program you can set up a short beep to sound after certain events. Step Action Activate the desired check button(s). Select volume for the acoustic signal or activate the «Mute all acoustic signals»…
Page 70: Barometer Setup

1. Setup ABL90 FLEX reference manual Barometer setup In this program you can adjust the automatic barometer in accordance with the reference barometer in your laboratory. Step Action Key in the desired pressure value on the keypad. Confirm with Enter. The value will be shown in the «Measured adjusted»…
Page 71: Languages

ABL90 FLEX reference manual 1. Setup Languages In this program you can select or change a language of your choice from the list of languages on your analyzer. NOTICE: It is only possible to select or change languages if they have been installed.
Page 72: Communications Setup

 Patient lookup setup  QA Portal connection See Rear in section Hardware, chapter 2 in the ABL90 FLEX operator’s manual for the identification and location of the serial RS-232 interface connection (COM) and the network (TCP/IP) RJ45 Ethernet connection.
Page 73: Lis/His Connection Setup

ABL90 FLEX reference manual 1. Setup Step Action Press the check button in the «RADIANCE communication» box to activate connection. The «Connection status» box with the handshake indicates an established connection to the RADIANCE system. The Icon in the «Connection status» box indicates the state of the RADIANCE connection.
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1. Setup ABL90 FLEX reference manual Step Action Press Add. Press Keyboard, type in the name of the connection instead of the default one, and press Enter. Press Back to return to the LIS/HIS connection setup screen. Select the high-level protocol according to the requirements of the connected device, using the up/down arrows in the box.
Page 75: Automatic Data Transmission Setup

ABL90 FLEX reference manual 1. Setup Step Action Connection specifications for serial low-level protocol: Press Edit to display the Connection specifications screen. Press Edit to enter the options screen and use the up/down arrows in each box to select baud rate, Com port and port configuration.
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1. Setup ABL90 FLEX reference manual Highlight a desired connection device on the screen, using the up/down arrows. Activate the relevant 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.
Page 77: Automatic Data Request Setup

ABL90 FLEX reference manual 1. Setup Automatic data request setup In this program you can select the conditions for requesting patient demographics automatically from the connected RADIANCE system or from the LIS/HIS computer system when entering patient ID, accession number or sampler ID.
Page 78: Patient Lookup Setup

1. Setup ABL90 FLEX reference manual Patient lookup setup In this program you can select the data source from which to obtain the patient information on the Patient identification screen. Step Action Select a data source from the established connections (local database, RADIANCE or LIS/HIS connections).
Page 79: Qa Portal Connection Setup

ABL90 FLEX reference manual 1. Setup QA Portal connection setup This program allows you to connect the analyzer to a QA Portal. If the QA Portal communication is enabled, the analyzer will automatically send QC results and Cal Verification measurements to the QA Portal.
Page 80: Disk Functions Setup

1. Setup ABL90 FLEX reference manual Disk functions setup Program Press Menu > Utilities > Setup > General setup > Disk functions setup and activate a button to enter a program. The following programs are available:  Automatic archiving  Automatic backup…
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ABL90 FLEX reference manual 1. Setup Step Action Activate the check button to select automatic archiving on the analyzer’s disk. To select another destination, deactivate the check button in the «Archive destination» box and press the drive icon that appears.
Page 82: Automatic Backup Setup

1. Setup ABL90 FLEX reference manual Automatic backup setup In this program you can select automatic backup of all data and system files. Step Action Activate the check button. Select time for automatic backup by highlighting the «Time» box and typing in the time, using the screen keypad.
Page 83: Printers

To install a new printer, press Install printer. The Add Printer Wizard program appears. This function can be used by a Radiometer service representative or a person with network knowledge. To get the desired printer installed the analyzer will run a restart.
Page 84: Automatic Printing

1. Setup ABL90 FLEX reference manual Automatic printing In this program you can select automatic printout of patient, QC (both manually and built-in) and calibration results plus Activity log messages. Step Action Activate the desired check buttons for automatic printout.
Page 85: Corrective Actions

ABL90 FLEX reference manual 1. Setup Corrective actions Program In this program you can select the following:  Corrective actions for the events listed in the «Conditions» box  Traffic light signal, if available, for an event  Analyzer action for the subsequent measurements…
Page 86: Explanation Of Corrective Actions

1. Setup ABL90 FLEX reference manual Replacement  Message on next patient result GREEN or schedule reminder(s) YELLOW  Lock analyzer when 10 % overdue GREEN or YELLOW System message(s)  Message on next patient result GREEN or present YELLOW…
Page 87: Miscellaneous Setup

Enables the additional buttons on the Patient approval 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 If enabled, the user-defined corrections (slope and corrections to QC offset) will be applied to the QC results.
Page 88: Selecting Hbf Correction

1. Setup ABL90 FLEX reference manual Option Function Show parameter bar If disabled, the parameter bar will not appear on the main screen. Activating/ Step Action deactivating an Scroll the list of options with the up/down arrows. option Highlight the option and press the check button next to it. To deactivate the option, press the check button again.
Page 89: Analyzer Messages

ABL90 FLEX reference manual 1. Setup Analyzer A message, sent from the RADIANCE system to the connected analyzer and messages displayed on the main screen, can be changed or deleted in this program. Step Action Press the Keyboard button, type the message (up to 40 characters long) and confirm with Enter.
Page 90: Setup Default Settings

ABL90 FLEX reference manual Setup default settings Access to Press Menu > Utilities > Disk functions > Restore default setup. Radiometer You can select the parts of the Setup to be set back to Radiometer defaults. default setup Operators and Item Setting…
Page 91
ABL90 FLEX reference manual 1. Setup Analysis setup Analysis setup Default setting Syringe modes S65 µL; ampoule QC. All user-defined modes are deleted. Capillary modes C65 µL. All user-defined modes are deleted. Parameter profile All parameters (except FHbF) are selected.
Page 92: Calibration Schedule

1. Setup ABL90 FLEX reference manual Analysis setup Default setting Patient reports Electrolyte values (continued) xxx – xxx xxx – xxx xxx – xxx xxx – xxx < New Line > Metabolite values cGlu xxx – xxx cLac xxx – xxx…
Page 93: Replacement Setup

ABL90 FLEX reference manual 1. Setup QC input setup Mandatory temperature Default temperature 25 °C QC schedule Built-in QC (S9030, S9040, S9050) 04:00, 12:00, 20:00 Westgard Rules All rules are «Off» Run QC after replacement Replacement Program Item Default setting…
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1. Setup ABL90 FLEX reference manual Units default settings: Parameter Unit Pressures mmHg ctBil µmol/L ctHb g/dL FCOHb FHbF FHHb FMetHb Gas fractions (a/A) FShunt  /cNa /cCl mmol/L mmol/L cGlu mmol/L cLac mmol/L Temperatures °C Vol % ctCO Vol % ·…
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ABL90 FLEX reference manual 1. Setup Peak flow Numerical L/min Liter flow Numerical L/min Numerical seconds PEEP Numerical Pressure support Numerical CPAP Numerical Numerical Rate SIMV Numerical Rate Flow-by Numerical L/min Numerical Rate I:E ratio Numerical None Wave Numerical None…
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1. Setup ABL90 FLEX reference manual Miscellaneous setup default settings: Event Default setting Analyzer locked Not set Enable estimated derived parameters Fixed pO /pCO decimals Enable general barcode support Enable patient result approval Apply parameter corrections to QC Log all measurement activities…
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Patient results, Calibration results, QC results, Activity log messages Patient lookup Local database Remote control Enable remote access Setups without The following setups have no Radiometer settings: Radiometer  Barometer setup settings  Time and date setup  Analyzer identification setup 1-77…
Page 98: Print Setup

1. Setup ABL90 FLEX reference manual Print setup With this program you can print out all or part of your analyzer setup. Step Action Press Menu > Utilities > Setup > Print analyzer setup . All check buttons are activated.
Page 99: Contents Of Setup Settings

 Parameters  General  Schedules, etc. You can restore the Radiometer default setup or a setup you have customized (Customer setup) and saved. Selecting or deselecting items in the setup – see Loading/restoring setup, chapter 2: Disk functions setup programs.
Page 100: General Group

1. Setup ABL90 FLEX reference manual The following settings (i.e. screens and their data) will be restored in the General group General group: Item Setup (screens) Analyzer setup  Corrective actions  Acoustic signals  Low level warning Ini file …
Page 101: Schedules, Etc

ABL90 FLEX reference manual 1. Setup The following ini files (i.e. screens and their data) will be restored in the Schedules, etc. Schedules, etc. group: Item Setup (screens) QC schedule  QC schedule (QC schedule is restored for the slots with the control solutions installed in them.
Page 102: Interfacing Facilities

1. Setup ABL90 FLEX reference manual Interfacing facilities Connecting a A mouse connected to the analyzer may be used to activate all the analyzer’s mouse screen functions instead of the operator touching the screen. A standard PS/2 port mouse or a USB mouse is the sole item that is required for connection to the analyzer.
Page 103: External Barcode Reader

 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. External An external barcode reader can be connected and used side by side with the barcode reader built-in barcode reader –…
Page 104: Sample Counter

1. Setup ABL90 FLEX reference manual Sample counter Purpose The sample counter lets you keep track of measurements, calibrations and QC. Press Utilities > Sample counter to enter the program. Description Element Function Parameter and List the parameters and how many times each has been Count measured by the analyzer.
Page 105
2. Disk functions 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: Disk Functions Setup Programs

To save the current setup of your analyzer. Load setup To load a previously saved setup. Restore To restore all or only some Radiometer default settings. default setup Definitions Setup data refers to information or files that configure the analyzer to operate according to settings defined in the Setup programs.
Page 107: Creating A Wdc Report

ABL90 FLEX reference manual 2. Disk functions setup programs Creating a WDC report Purpose With this function you can make a Worldwide DATACHECK (WDC) file for reporting monthly quality control data. For information on Worldwide DATACHECK reporting, see the Worldwide DATACHECK manual.
Page 108: Backing Up All Data

Restore All Data function. NOTICE: It is the user’s responsibility to ensure that all valuable data is regularly backed up. During the analyzer warranty period Radiometer accepts warranty responsibility only for the original storage hardware and installed…
Page 109
ABL90 FLEX reference manual 2. Disk functions setup programs Step Action Press Change destination to choose the destination. Highlight the drive or folder by touching it on the screen. Press Expand/Collapse to open a folder in a directory or within a folder.
Page 110: Restoring All Data

2. Disk functions setup programs ABL90 FLEX reference manual Restoring all data Purpose You can restore all data in case of loss or damage, provided the backup of all your data is available. Step Action Press Change source to choose the source drive/directory.
Page 111: Exporting Data Logs

ABL90 FLEX reference manual 2. Disk functions setup programs Exporting data logs Purpose You can export data from the data logs to a CD-RW, removable disk or network. The exported files are made in a form of a compressed «comma separated value (CSV)»…
Page 112: Importing/Exporting Archives

2. Disk functions setup programs ABL90 FLEX reference manual Importing/exporting archives Purpose This function allows you to do the following:  Export (or delete) archived data logs stored onto any drive  Import externally archived data logs into the analyzer’s archive directory from…
Page 113: Saving Setup

ABL90 FLEX reference manual 2. Disk functions setup programs Saving setup Purpose You can copy your analyzer’s current setup configuration onto a CD-RW, removable drive, or network. It can be reloaded if the current setup is lost or damaged or if the same setup configuration should be loaded on other analyzers without performing all the Setup programs.
Page 114: Loading/Restoring Setup

2. Disk functions setup programs ABL90 FLEX reference manual Loading/restoring setup Purpose You can reinstall a saved setup quickly and easily without performing the Setup programs. If desired, only part of the setup can be loaded, e.g. operators. Step Action Press Select all to include all items from the list on the screen.
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: Wet Section

All solutions for the ABL90 FLEX analyzer are contained in the solution pack. Gas tanks are not necessary with the ABL90 FLEX analyzer, as gas is included in the solution pack. Contents of…
Page 117: Wet Section Diagram

ABL90 FLEX reference manual 3. Wet section Wet section diagram Diagram The following is a schematic diagram of the wet section of the ABL90 FLEX analyzer. Item Part Item Part Oximetry module Waste pouch Reference electrode CAL 3 pouch Sensor interface…
Page 118: Measuring Processes

3. Wet section ABL90 FLEX reference manual Measuring processes Introduction The following pages describe the process that occurs within the analyzer during sample introduction, rinse, calibration and quality controls. The various types of sampling modes are discussed separately. All processes refer to the wet section diagram earlier in this chapter.
Page 119: Patient Samples

3. Wet section Patient samples Measuring The following table describes the analytical process of a blood sample process measurement with the ABL90 FLEX analyzer system. Stage Description The analyzer is ready to accept a patient sample.  «Ready» message is displayed …
Page 120: Rinse Process

3. Wet section ABL90 FLEX reference manual Rinse process After a measurement is complete a rinse is performed. The rinse process is the same, no matter what kind of measurement (patient measurement, QC and calibration) is performed. The following table describes this rinse process.
Page 121: Calibration

Also the wavelength is calibrated. For further information on the ctHb calibration, see section tHb calibration in chapter 6: Calibration in the ABL90 FLEX operator’s manual. ctHb and the oximetry parameters are status calibrated every four hours and if the temperature of the oximetry optical system changes to a temperature outside drift limits.
Page 122: Automatic Qc

3. Wet section ABL90 FLEX reference manual Automatic QC Measuring The solution pack contains three levels of QC solution. The analyzer is designed process to run each level once every 24 hours. However, it is possible to set up a schedule to run QC more often, if required, as described in section QC Schedule in chapter 1.
Page 123: Measuring Process

ABL90 FLEX reference manual 3. Wet section Manual QC samples Measuring The following table describes the analytical process of a manual QC process measurement using the manual QC option. Stage Description The analyzer is ready to accept a QC sample.
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3. Wet section ABL90 FLEX reference manual 3-10…
Page 125: Electronics

4. Electronics General information…………….. 4-2 Electronic boards and components…………. 4-3…
Page 126: General Information

4. Electronics ABL90 FLEX reference manual General information General The electronics of the ABL90 FLEX analyzer can be subdivided into the following information modules:  The user interface module which consists of a touch screen, a built-in barcode scanner and an embedded computer module …
Page 127: Inlet Positioning

ABL90 FLEX operator’s manual 4. Electronics Electronic boards and components Power supply Universal power supply with input from 100-240 VAC, 50-60 Hz. It includes three internal DC output levels, +5 VDC, +12 VDC, and +24 VDC, distributed to different parts of analyzer electronics.
Page 128: Printer Unit

4. Electronics ABL90 FLEX reference manual CPU Unit: The CPU Unit runs the operating system and application software. It includes a compact ETX-PC module mounted on a baseboard that interfaces signals to internal and external connectors. It also includes a speaker, a fan and a solid-state disk (CF), in which all operating system and software files are stored, along with system database files.
Page 129: Sensors And Measuring Technologies

5. Sensors and measuring technologies Overview ………………..5-2 General construction …………….5-2 General measuring principles …………… 5-3 Calibration ………………… 5-4 General information …………….5-5 The calibration equation …………..5-6 Sensitivity ………………5-7 Measurement ………………5-8 Quality Management …………….5-9 Reference electrode…………….5-13 Background information about the reference electrode ……5-14 Construction of the reference electrode……….5-15 pH and electrolyte sensors …………..
Page 130: Overview

5. Sensors and optical system ABL90 FLEX reference manual Overview General construction Sensors In this manual, the term sensor refers to an 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.
Page 131: General Measuring Principles

ABL90 FLEX reference manual 5. Sensors and optical system General measuring principles Introduction There are four different measuring principles employed in the sensors in the ABL90 FLEX analyzer.  Potentiometry: The potential of a sensor chain is recorded using a voltmeter, and related to the concentration of the sample (the Nernst equation).
Page 132: Calibration

5. Sensors and optical system ABL90 FLEX reference manual Calibration General information …………….5-5 The calibration equation …………..5-6 Sensitivity ………………5-7 Measurement ………………5-8 Quality management…………….5-9…
Page 133: General Information

ABL90 FLEX reference manual 5. Sensors and optical system General information Definition Calibration is the process that relates the electrode signals during the calibration sequence to the values of the calibrating solutions and air. Calibration enables the electrode signals to be converted to the accurate values for an unknown sample.
Page 134: The Calibration Equation

5. Sensors and optical system ABL90 FLEX reference manual The calibration equation Definition The calibration equation expresses the relationship between the electrical measurement at a sensor and the concentration of the substrate specific to the sensor. The calibration line forms the basis of the scale used by the analyzer to convert electrical measurements to concentrations.
Page 135: Sensitivity

ABL90 FLEX reference manual 5. Sensors and optical system Sensitivity Definition The electrode sensitivity illustrates the slope of the calibration line compared to the slope of the theoretical electrode. The sensitivity of the theoretical electrode is 100 % or 1.00.
Page 136: Measurement

5. Sensors and optical system ABL90 FLEX reference manual Measurement Sample A blood sample gives a potential reading of 4.8 mV at the pH sensor. Reading measurements off from the calibration line shown below, this potential corresponds to a pH of 7.35.
Page 137: Quality Management

ABL90 FLEX reference manual 5. Sensors and optical system Quality Management This section describes the functionalities that the analyzer, apart from the built- Introduction in quality checks, applies to ensure the measurement quality. System/ System checks: analysis checks System checks are performed regularly and automatically consist of the following checks: …
Page 138
5. Sensors and optical system ABL90 FLEX reference manual  Electronical checks (to check the sensor impedance and leak current.)  Measurement preparation checks (to ensure that the analyzer, after each activity, is ready for a new measurement.)  Consumable lifetime checks (To check the expiration date and lifetime of the sensor cassette.
Page 139
ABL90 FLEX reference manual 5. Sensors and optical system the p CO sensor is also checked. If the check fails, the check is repeated. If the second check fails, the User intervention required mode is entered. During liquid sensor checks, the inlet, sensor and oxi liquid sensors check the liquid transport in the wet section.
Page 140: Calibration

5. Sensors and optical system ABL90 FLEX reference manual Calibration The following additional parameters are checked:  Sensitivity  Status In case of error in a scheduled calibration, a new calibration is automatically performed. Measurement A 1-point calibration is automatically performed with every measurement.
Page 141: Reference Electrode

ABL90 FLEX reference manual 5. Sensors and optical system Reference electrode Background information about the reference electrode ……5-14 Construction of the reference electrode……….5-15 5-13…
Page 142: Background Information About The Reference Electrode

5. Sensors and optical system ABL90 FLEX reference manual Background information about the reference electrode Purpose The purpose of the reference electrode is to provide a stable, fixed potential, against which other potential differences can be measured. The potential at the reference electrode is not altered by the sample composition.
Page 143: Construction Of The Reference Electrode

ABL90 FLEX reference manual 5. Sensors and optical system Construction of the reference electrode Diagram Parts and Item Part Description/Function functions Membrane Interface to the sample. Electrolyte Acts as a salt-bridge solution that maintains solution an electrical contact between the electrode and the sample.
Page 144: Ph And Electrolyte Sensors

5. Sensors and optical system ABL90 FLEX reference manual 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: Construction Of The Ph And Electrolyte Sensors

ABL90 FLEX reference manual 5. Sensors and optical system Construction of the pH and electrolyte sensors Diagram The pH and electrolyte sensors are of solid-state design with a H – – sensitive PVC membrane. The Cl sensor is of solid-state design with a Cl sensitive epoxy membrane.
Page 146: Measuring Principle Of The Ph And Electrolyte Sensors

5. Sensors and optical system ABL90 FLEX reference manual Measuring principle of the pH and electrolyte sensors Potentiometric The pH and electrolyte sensors are measured according to the potentiometric measuring measuring principle, where the potential of an electrode chain recorded at a principle voltmeter is related to the concentration of a substance via the Nernst equation.
Page 147: Unknown Potential

ABL90 FLEX reference manual 5. Sensors and optical system Element Potential Symbol Reference electrode Known and constant when the Ag/AgCl is immersed in the electrolyte solution. Liquid junction between the Known and constant. electrolyte solution in the Independent of sample reference electrode and the composition.
Page 148: Calibration Of The Ph And Electrolyte Sensors

5. Sensors and optical system ABL90 FLEX reference manual Calibration of the pH and electrolyte sensors Introduction The pH and electrolyte sensors are calibrated by determining the E sensitivity from 2-point calibrations. Slight variations in sensor performance between calibrations are addressed by performing a measurement of CAL 1 within every sample measurement process.
Page 149: Measurement — Ph And Electrolytes

ABL90 FLEX reference manual 5. Sensors and optical system Measurement – pH and electrolytes Measurement The pH value measured from the sample is calculated as follows, from the sensor signal of the sample mV sample    sample cal1 cal1 …
Page 150: Pco Sensor

5. Sensors and optical system ABL90 FLEX reference manual sensor Construction of the p CO sensor …………5-23 Measuring principle of the p CO sensor ……….5-24 Calibration of the p CO sensor ………….5-26 Measurement – p CO ……………..5-27 Corrections – p CO …………….5-27…
Page 151: Diagram

ABL90 FLEX reference manual 5. Sensors and optical system Construction of the pCO sensor Diagram Parts and Item Part Description description Silicone membrane A membrane separating the sample and the electrolyte solution. Is only permeable to CO Electrolyte solution A solution separating the silicone membrane and the pH membrane, Ag/AgCl sensors.
Page 152: Measuring Principle Of The Pco Sensor

5. Sensors and optical system ABL90 FLEX reference manual Measuring principle of the pCO sensor Electrode chain The electrode chain (or electrical circuit) set up to measure p CO is illustrated in the following diagram: Parts and The electrode chain describes an electrical circuit consisting of the following:…
Page 153: Measuring Process

ABL90 FLEX reference manual 5. Sensors and optical system Measuring The following is an account of the measuring process in the p CO sensor. process Part Function Transport of CO from the sample permeates the membrane. Dissolution of CO The CO dissolves in the electrolyte solution.
Page 154: Calibration Of The Pco Sensor

Slight variations in sensor performance between calibrations are addressed by performing a measurement on CAL 1 within every sample measurement process. Calibration The ABL90 FLEX analyzer is equipped with a solution pack. This pack contains levels precision-tonometered fluids. The tonometry calibration gas mixture is of a known composition.
Page 155: Measurement — Pco

ABL90 FLEX reference manual 5. Sensors and optical system Measurement – pCO Measurement The p CO value measured from the sample is calculated as follows, from the sensor signal of the sample mV sample  sample cal1  CO (cal1) 10 …
Page 156: Po 2 Sensor

5. Sensors and optical system ABL90 FLEX reference manual sensor Measuring principle of the p O sensor ………..5-29 Calibration of the p O sensor……………5-30 Measurement – p O …………….5-31 5-28…
Page 157: Optical System For Po

ABL90 FLEX reference manual 5. Sensors and optical system Measuring principle of the pO sensor Optical system The optical system for p O is based on the ability of O to reduce the intensity for pO and time constant of the phosphorescence from a phosphorescent dye that is in contact with the sample.
Page 158: Sensitivity

5. Sensors and optical system ABL90 FLEX reference manual Calibration of the pO sensor Introduction The p O sensor is calibrated to determine its sensitivity by measuring one calibration point during a sensitivity calibration process. Performance of the sensor from calibration to calibration is checked and during sample or quality control analysis any drift on sensitivity is checked.
Page 159: Status

ABL90 FLEX reference manual 5. Sensors and optical system Measurement — pO On whole blood, p O is adjusted with the sensitivity value and the measured p O is therefore determined as follows: O (meas) O (sens,adjusted)  The measured value is applied a 2…
Page 160: Metabolite Sensors

5. Sensors and optical system ABL90 FLEX reference manual 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 5-32…
Page 161: Construction Of The Metabolite Sensors

ABL90 FLEX reference manual 5. Sensors and optical system Construction of the metabolite sensors Basic The c Glu and c Lac sensors are three-electrode sensors consisting of an internal description silver/silver chloride reference electrode, a platinum auxiliary electrode, and a platinum anode.
Page 162: Calibration Of The Metabolite Sensors

5. Sensors and optical system ABL90 FLEX reference manual  The baseline is extrapolated throughout the whole electrode calibration or sample measurement period, and represents the zero current time function  The I baseline is used in the determination of the sensitivity of the…
Page 163: Measurement — Metabolites

ABL90 FLEX reference manual 5. Sensors and optical system Measurement – metabolites Measurement The glucose or lactate concentration in a sample is calculated from the following equation, using the difference between the current in the sample and the extrapolated zero current from the rinse solution: …
Page 164: Measuring Principle Of The Metabolite Sensors

5. Sensors and optical system ABL90 FLEX reference manual Measuring principle of the metabolite sensors Amperometric The c Glu and c Lac sensors are measured according to the amperometric measuring measuring principle, in which the magnitude of an electrical current flowing…
Page 165: Measuring Process

ABL90 FLEX reference manual 5. Sensors and optical system Measuring A constant polarization voltage is applied to the electrode chain. The current process through this chain is measured by an amperemeter. Glucose or lactate molecules, in solution, are transported across the outer layer of a multilayer membrane system.
Page 166: C Thb And Derivates

5. Sensors and optical system ABL90 FLEX reference manual tHb and derivates General information …………….5-39 Calibration of the optical system …………5-44 Correcting for interferences …………..5-45 Measurement and corrections…………..5-47 5-38…
Page 167: General Information

ABL90 FLEX reference manual 5. Sensors and optical system General information Measured The optical system of the ABL90 FLEX analyzer is designed to measure the parameters following parameters: Parameter Description c tHb Concentration of total hemoglobin Oxygen saturation Fraction of oxyhemoglobin…
Page 168: Measurement Cycle

5. Sensors and optical system ABL90 FLEX reference manual Measurement The method used in the analyzer’s optical system is visible absorption cycle spectroscopy. The measurement cycle consists of the following steps: Step Description The blood sample is transported to the cuvette positioned in the hemolyzer unit.
Page 169: Absorbance

ABL90 FLEX reference manual 5. Sensors and optical system Absorbance The absorbance (A) of a compound is defined as the logarithm of the ratio of the light intensity before and after transmission through the compound. In practice it is the logarithm of the ratio of the light intensity transmitted through water to the light intensity transmitted through the compound.
Page 170: Spectrum Examples

5. Sensors and optical system ABL90 FLEX reference manual Spectrum The figure below shows three spectra; pure O Hb, pure HHb in a low examples concentration, a spectrum of 92 % oxygenated hemoglobin obtained by adding the spectra of O Hb and HHb.
Page 171: Matrix Of Constants

ABL90 FLEX reference manual 5. Sensors and optical system Matrix of  The constants ( ) are determined using Multivariate Data Analysis  2  where constants 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.
Page 172: Calibration Of The Optical System

It is recommended that a tHb calibration is performed every three months. See frequency section tHb calibration in chapter 6: Calibration in the ABL90 FLEX operator’s manual for further information about the tHb calibration. 5-44…
Page 173: Correcting For Interferences

It is thus important when measuring hemoglobin levels in premature neonates and neonates aged 0-3 months, as well as adults suffering from e.g. thalassemia, to take into account this difference [4], and the ABL90 FLEX analyzer automatically corrects for HbF.
Page 174: Residual Spectrum

5. Sensors and optical system ABL90 FLEX reference manual The measured spectrum is compared to a model spectrum calculated from the Residual determined concentrations. The difference between these two spectra is called spectrum the residual spectrum. If this residual spectrum is too high, the oximetry module…
Page 175: Measurement And Corrections

ABL90 FLEX reference manual 5. Sensors and optical system Measurement and corrections Oximetry The oximetry parameters are calculated as follows: parameters Parameter Equation c tHb(meas)  c O Hb + c COHb + c HHb + c MetHb O Hb …
Page 176: Restrictions

5. Sensors and optical system ABL90 FLEX reference manual Restrictions The following parameters will not be calculated: Parameter Is not calculated if… , F COHb, F MetHb, c tHb < 1 mmol/L F HHb, F O c eHb = c HHb + c O Hb <…
Page 177
ABL90 FLEX reference manual 5. Sensors and optical system The uncorrected hemoglobin concentration, c tHb(sample), measured on Corrections for capillary or syringe samples is corrected as follows: ctHb tHb(sample) tHb(sample,corr)  where: c tHb(sample,corr) corrected c tHb analyzer-dependent cuvette path length constant…
Page 178: References

Dr. Techn. Thesuis. NTH Univ. of Trondheim, 1986. Krzeminski A. Why correct for fetal hemoglobin in blood oximetry measurements? Radiometer Publication Info. No. 1992-3. Copenhagen: Radiometer Medical A/S, 1992. Huehns ER, Beanen GH. Developmental changes in human hemoglobins. Clin Dev Med 1971;…
Page 179
6. User-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: User-Defined Corrections

NOTICE: Since the performance of all ABL90 FLEX analyzers is tested as described in chapter 7: Performance characteristics in this manual, and each…
Page 181: User-Defined Corrections

6. User-defined corrections It should be noted that in order to define corrections:  Measurements should be taken on the ABL90 FLEX analyzer without user- defined corrections, and on a single reference analyzer  A series of measurements that cover the entire measuring range should be performed …
Page 182: Correction Factors For Ph And Blood Gases

6. User-defined corrections ABL90 FLEX reference manual Correction factors for pH and blood gases Correcting The following corrections to the slope and offset are possible within the stated limits for: slope and offset – Arterial, venous, and a-v samples: Parameter…
Page 183: Correction Factors For Oximetry Parameters

NOTICE: In order to define the corrections accurately the measurements of the oximetry parameters 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.
Page 184: Fcohb

Description Units Fraction Sample Radiometer recommends that ctHb in the adult samples (with FHbF = 0) and fetal samples (with high FHbF) is set to  15 g/dL (9.3 mmol/L), sO  100 % and pH  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.
Page 185: Ctbil

Description Units mol/L Sample Radiometer recommends that human plasma or serum is used with pH  7.4 (the analyzer reading). Zero point sample could be adult sample (ctBil  0 mol/L) and maximum point could be an unconjugated bilirubin sample (neonatal) with ctBil …
Page 186: Correction Factors For Electrolyte And Metabolite Parameters

0.750-1.250 5.0 mmol/L cLac 0.750-1.250 5.0 mmol/L Resetting The Radiometer default values for the electrolyte and metabolite parameters corrections to must be reset manually by the user on the Parameter setup screen to 1.000 default values for each parameter.
Page 187: Performance Characteristics

7. Performance characteristics General information …………….. 7-2 Definition of terms………………. 7-3 Test conditions………………7-6 Performance test results – chart description ……….7-7 Performance test results – pH …………..7-8 Performance test results – pCO …………..7-8 Performance test results – pO …………..
Page 188: General Information

FLEX analyzer and the ABL735 analyzer. Performance specifications of the ABL90 FLEX analyzers are described, using the following:  Bias = the mean difference between the ABL90 FLEX analyzer and the primary Prim.ref reference methods.  Bias = the mean difference between the ABL90 FLEX analyzer and the ABL735 Sec.ref…
Page 189: Definition Of Terms

Bias  X Prim.ref ABL90 FLEX Primary Reference method Bias is a relative bias between the ABL90 FLEX analyzer and the ABL735 analyzer Sec.Ref in macromode (C195 µL mode), and is determined as follows: Bias  X Sec.ref ABL90 FLEX ABL735 Bias given in the tables in this chapter have been obtained experimentally.
Page 190
7. Performance characteristics ABL90 FLEX reference manual Secondary Parameter Primary Reference Method Reference Reference Method c Glu Spectrophotometry, using the [Ref. 5] hexokinase (HK) method recommended by NCCLS, measured on serum. c Lac Spectrophotometry using a lactate [Ref. 8] dehydrogenase (LDH) method, measured on serum.
Page 191: Coefficient Of Variation (Cv%)

The degree of variation in the results is a measure of the precision of the analyzer. The table on the next page describes the parameters used to characterize precision obtained via the performance tests on the ABL90 FLEX analyzer. [Ref. 9] Parameter Description…
Page 192: Test Conditions

Primary/secondary As specified for each parameter earlier in this reference methods chapter. Analyzers and test 8-10 ABL90 FLEX analyzers were tested in syringe modes and capillary mode. Blood samples Heparinized blood samples from healthy, voluntary donors. The blood is prepared to obtain different concentration levels of each measured parameter.
Page 193: Performance Test Results — Chart Description

ABL90 FLEX reference manual 7. Performance characteristics Performance test results – chart description General reference for the entire section: [Ref. 11]. Modes Tests were performed in the following modes: Mode Volume Syringe 65 µL Capillary 65 µL Number of The number of measurements during the test are listed below:…
Page 194: Performance Test Results — Ph

7. Performance characteristics ABL90 FLEX reference manual Performance test results – pH Reference Capillary-type glass pH electrode with a saturated calomel reference electrode and a method liquid junction saturated with KCl (BMS Mk2) [Ref. 1,2]. The calibration standards are traceable to the Primary Reference Standards for pH.
Page 195: Performance Test Results — Po

ABL90 FLEX reference manual 7. Performance characteristics Performance test results – pO Reference Tonometry [Ref. 3]. method The gases used for tonometry are traceable to NIST-certified Standard Reference Materials. Bias Bias Prim.ref Prim.ref Repeatability – (mmHg) blood samples 30.0 1.18 0.21…
Page 196: Performance Test Results — Cna

7. Performance characteristics ABL90 FLEX reference manual Performance test results – cNa Reference NIST-certified Standard Reference Material SRM 909b (human serum) and Radiometer- method specified standard serum material (specified using flame photometry). Bias Bias Prim.ref Prim.ref Repeatability – (mmol/L) blood samples 1.76…
Page 197: Performance Test Results — Cca

ABL90 FLEX reference manual 7. Performance characteristics Performance test results – cCa Reference The calcium transfer standards were used. These are traceable to NIST SRM915 and method have an ionic strength of 160.0 mmol per kg of water and pH 7.40 at 37 °C, using 1 mmol/L (37 °C) HEPES buffer.
Page 198: Performance Test Results — Clac

7. Performance characteristics ABL90 FLEX reference manual Blood, pO <90 mmHg cGlu Bias Prim.ref (mmol/L) -0.09 0.01 0.10 0.29 14.3 -0.12 0.05 0.18 0.47 10.0 0.08 0.06 0.27 0.61 25.0 -1.73 0.28 0.84 13.5 -3.28 0.62 1.92 17.6 Serum pool, pO >90 mmHg…
Page 199: Performance Test Results — Cthb

ABL90 FLEX reference manual 7. Performance characteristics Blood, pO <90 mmHg cLac Bias Prim.ref (mmol/L) 0.03 0.01 0.08 26.7 0.19 62.3 0.03 0.03 0.09 0.21 21.0 0.09 0.10 0.33 0.74 14.8 10.0 -0.05 0.08 0.78 1.58 15.8 15.0 -0.01 0.10 1.17…
Page 200: Performance Test Results — So

7. Performance characteristics ABL90 FLEX reference manual Performance test results – sO Reference Tonometry: method 100%: whole blood is tonometered with a gas mixture containing 94.4% O and 5.6% 0%: whole blood is tonometered with a gas mixture containing 94.4% N and 5.6% CO…
Page 201: Reference Method

ABL90 FLEX reference manual 7. Performance characteristics Performance test results – FO Reference Measured according to the following relation: method Hb = 1 — ( F HHb + F COHb + F MetHb) Setup: Adult samples. HbF correction is not activated.
Page 202: Performance Test Results — Fmethb

7. Performance characteristics ABL90 FLEX reference manual Bias ctHb FCOHb Bias Sec.ref Sec.ref Repeatability – (g/dL) blood samples 0.00 0.07 0.23 0.45 0.08 0.07 0.26 0.59 11.8 10.0 0.04 0.06 0.34 0.71 20.0 0.11 0.07 0.67 1.42 30.0 0.17 0.07 0.68…
Page 203: Performance Test Results — Fhhb

ABL90 FLEX reference manual 7. Performance characteristics Performance test results – FHHb Reference 0%: whole blood is tonometered with a gas mixture containing 94.4% N and 5.6% CO method + dithionite. Setup: Adult samples. HbF correction is not activated. Bias…
Page 204: Reference Method

7. Performance characteristics ABL90 FLEX reference manual Performance test results – bilirubin The reference method for total bilirubin is a spectrofotometric method (wet chemistry Reference method based on a method from Bayer Healthcare, Tarrytown USA. The method is calibrated using NIST SRM916a Bilirubin.
Page 205
ABL90 FLEX reference manual 7. Performance characteristics For adult use: Adult samples within reference range: The uncertainty in the bilirubin measurement on whole blood can, in some cases, exceed the level required to measure normal bilirubin levels for children older than 3 months and adults (bilirubin reference range 4-22 µmol/L).
Page 206: Interference Tests

7. Performance characteristics ABL90 FLEX reference manual The same data as above but depicted in a Bland-Altman plot below. ctBil Lines indicate “Mean” and +/- “15 umol or 10%”. Values are in µmol/L. Difference = ABL90 – Modular. Interference tests The results from the interference tests are given as the deviation from the correct result [Ref.
Page 207: Electrolytes

ABL90 FLEX reference manual 7. Performance characteristics Electrolytes The following interference results are found for the electrolyte electrodes: Interference on …..c Na c Ca c Cl (4 mM Test con- Test (140 mM (1.25 mM (105 mM level) Substance…
Page 208
7. Performance characteristics ABL90 FLEX reference manual Interference on …..c Na c Ca c Cl (4 mM Test con- Test (140 mM (1.25 mM (105 mM level) Substance centration matrix level) level) level) Acetylsalicylic acid 0.91 mM <1 Plasma 1.21 mM…
Page 209
ABL90 FLEX reference manual 7. Performance characteristics Metabolites The following interference results are found for the metabolite electrodes: Interference on ..Test Test Substance Concentration matrix Glu mM Lac mM Acetaminophen=paracetamol 2 mM Whole blood < 0.1 < 0.1 Acetylsalicylic acid Whole blood 3.62 mM…
Page 210
7. Performance characteristics ABL90 FLEX reference manual Interference on ..Test Test Substance Concentration matrix Glu mM Lac mM 2-deoxy Glucose Whole blood 2.5 mM 2.25 Whole blood 3.33 mM 2.88 Whole blood 5 mM 4.58 < 0.1 Whole blood 10 mM 9.58…
Page 211: Oximetry Parameters

ABL90 FLEX reference manual 7. Performance characteristics Oximetry The substances against which the oximetry parameters ( c tHb, s O , F O Hb, F COHb, parameters F MetHb, F HHb, F HbF) and c tBil were tested for interference are given in the table…
Page 212: Ctbil Sensitivity For Mchc Variations

7. Performance characteristics ABL90 FLEX reference manual ctHb FCOHb FMetHb FHHb FHbF ctBil g/dL µmol/L Limit for clinical relevance….. Level 0.5 g/dL µmol/L 2 g/L 2.29 -4.12 -16.23 2.85 9.87 3.52 <|30| Cyanocobalamin 0.8 g/L 1.15 -2.02 -8.68 1.53 5.33 1.82…
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ABL90 FLEX reference manual 7. Performance characteristics Subjects MCHC MCHC 95 mean 95 % range mean, g/L % range, Adults 0.47 0.39-0.55 310-370 Women Adults 0.42 0.36-0.48 300-360 Boys Newborn 0.59 0.53-0.65 320-340 1 month 0.50 0.44-0.56 310-330 3 months 0.45…
Page 214: Anticoagulants (Sampling)

Na , c K and c Glu 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, p CO…
Page 215: List Of References

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.
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7. Performance characteristics ABL90 FLEX reference manual 7-30…
Page 217: Parameters

8. Parameters General information…………….8-2 Measured 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: General Information

ABL90 FLEX reference manual General information The Deep The Deep Picture developed by Radiometer [1] (visit our website www.deep- Picture picture.com) expands traditional pH and blood gas analysis by evaluating the capability of arterial blood to carry sufficient oxygen to tissues and to release it.
Page 219: Symbols

ABL90 FLEX reference manual 8. Parameters Symbols The symbols for the parameters are based on the principles described by Wandrup [2]. Each symbol consists of three parts, described below: 1. Property A symbol in italics p for pressure describing the quantity…
Page 220: Ranges And Limits

8. Parameters ABL90 FLEX reference manual Ranges and The following ranges are used: limits Range Description Indication The range of indication for a parameter is the range within which the analyzer is physically capable of measuring. Reportable Is user-defined; is equal to or narrower than the range of indication.
Page 221: Measured Parameters

ABL90 FLEX reference manual 8. Parameters Measured Some of the listed parameters are measured, depending on the analyzer parameters configuration. In these cases the equation given only applies if that parameter is not directly measured by the analyzer. Sample type Unless otherwise stated, a parameter will be calculated or estimated irrespective of the choice on the Patient Identification screen: «Arterial», «Capillary»,…
Page 222: Measured Parameters

8. Parameters ABL90 FLEX reference manual Measured parameters General The following is the used: information male female Reference For adult arterial blood range Reference [10] (unless otherwise specified) Definition Indicates the acidity or alkalinity of the sample. Unit Range of indication 6.300-8.000…
Page 223: Baro

ABL90 FLEX reference manual 8. Parameters Is used for both blood and expired air samples. Definition Partial pressure (or tension) of oxygen in blood. High and low pO values of arterial blood indicate blood hyperoxia and hypoxia, respectively. Unit mmHg; kPa; Torr Range of indication mmHg;…
Page 224: Fo Hb

8. Parameters ABL90 FLEX reference manual Can also be calculated: see Derived parameters eq. 39. Definition Oxygen saturation, the ratio between the concentrations of oxyhemoglobin and the hemoglobin minus the dyshemoglobins. Unit %; fraction Range of indication %: –2-102 Fraction: –0.02-1.02…
Page 225: Fhhb

ABL90 FLEX reference manual 8. Parameters FHHb Can also be calculated: see Derived parameters eq. 41. Definition Fraction of deoxyhemoglobin in total hemoglobin in blood. Deoxyhemoglobin is the part of total hemoglobin which can bind oxygen forming oxyhemoglobin. It is also termed reduced hemoglobin, RHb.
Page 226: Ccl

8. Parameters ABL90 FLEX reference manual Definition Concentration of chloride ions in plasma. Unit mmol/L; meq/L Range of indication mmol/L; meq/L: 7-350 Reference range 98-106 mmol/L (m, f) Conversion of units mmol/L = meq/L cGlu Definition Concentration of D-glucose in plasma.
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ABL90 FLEX reference manual 8. Parameters The reference ranges are as follows: ctBil 24 hrs, premature 103-205 µmol/L 1.0-8.0 mg/dL 10-80 mg/L 24 hrs, full-term 34-103 µmol/L 2.0-6.0 mg/dL 20-60 mg/L 48 hrs, premature 103-205 µmol/L 6-12 mg/dL 60-120 mg/L 48 hrs…
Page 228
8. Parameters ABL90 FLEX reference manual Symbol Unit Numerical format within the following ranges: Range Range -1000.0 1000.0 fraction -10.000 10.000 FCOHb -1000.0 1000.0 fraction -10.000 10.000 FMetHb -1000.0 1000.0 fraction -10.000 10.000 FHHb -1000.0 1000.0 fraction -10.000 10.000 FHbF…
Page 229: Fo (I)

ABL90 FLEX reference manual 8. Parameters Input parameters Definition Input parameters are the parameters keyed in by the operator on the Patient Identification screen or transferred from an interfaced database. All input parameters are given in this section. Definition Patient temperature.
Page 230: Vco

8. Parameters ABL90 FLEX reference manual – Definition Oxygen saturation of mixed venous blood. Input range/Unit %: 0.0-100.0 fraction: 0.000-1.000 · Definition Cardiac output; volume of blood delivered from the left ventricle into the aorta per unit of time. Also termed CO or C.O.
Page 231: Derived Parameters

ABL90 FLEX reference manual 8. Parameters Derived parameters General In the Type column the following symbols are used: information  ms for measured parameters  dv for derived parameters  in for input parameters Acid-base Symbol Definition Type derived pH(T) pH of blood at patient temperature.
Page 232: Oxygen Derived Parameters

8. Parameters ABL90 FLEX reference manual Symbol Definition Type pH(st) Standard pH (or eucapnic pH), defined as the pH of plasma of blood equilibrated to = 5.33 kPa (40 mmHg). By ensuring the normal value of pCO , the respiratory influence from pH is removed, and pH(P,st) therefore reflects the meta- bolic status of the blood plasma.
Page 233
ABL90 FLEX reference manual 8. Parameters Symbol Definition Type p50(st) Partial pressure (or tension) of oxygen at half saturation (50 %) in blood at standard conditions: temperature = 37 °C pH = 7.40 = 5.33 kPa FCOHb, FMetHb, FHbF set to 0…
Page 234
8. Parameters ABL90 FLEX reference manual Symbol Definition Type · Cardiac output; volume of blood delivered from dv/in the left ventricle into the aorta per unit of time. Also termed CO or C.O. · Oxygen consumption; total amount of oxygen dv/in utilized by the whole organism per unit of time.
Page 235: Units And Numerical Format Of Derived Parameters

ABL90 FLEX reference manual 8. Parameters Units and numerical format of derived parameters Calculated Derived parameters are calculated or estimated on the basis of measured and keyed-in data. Calculations are made using equations programmed into the versus estimated analyzer. The accuracy of the calculations depends on the input parameters parameters keyed into the analyzer’s computer.
Page 236: Possible Ranges And Precision (Number Of Decimals)

8. Parameters ABL90 FLEX reference manual Possible The following table shows the possible ranges and precision (number of ranges and decimals) of the measured parameters. These ranges can be narrowed by precision calculation ranges, reportable ranges, range of indication, etc., but should be (number of taken into consideration when external systems are interfaced to the analyzer.
Page 237
ABL90 FLEX reference manual 8. Parameters Symbol Unit Numerical format within the following ranges Range Range (Aa) mmHg 750.1 0.00 100.00 (Aa,T) mmHg 750.1 0.00 100.00 (a/A) 10000.0 fraction 0.000 100.000 (a/A, T) 10000.0 fraction 0.000 100.000 (a)/FO mmHg 99.9 7501 0.00…
Page 238
8. Parameters ABL90 FLEX reference manual Symbol Unit Numerical format Range Range FShunt -10.0 110.0 fraction -0.100 1.100 FShunt(T) -10.0 110.0 fraction -0.100 1.100 999900 fraction -0.10 9999.00 RI(T) 999900 fraction -0.10 9999.00 fraction -0.10 10.0 /V(dry -10.0 1.100 air) fraction -0.100…
Page 239: Chco (P,St)

(P) includes ions of hydrogen carbonate, carbonate and carbamate in the plasma. NOTICE: The formula is different from previous Radiometer analyzers. The pK now constant, to be in accordance with NCCLS (CLSI)-approved guidelines [24]. The change corresponds to 5% in the pH range 7-7.8.
Page 240: Ctco (P)

7.7)(pH  7.4)) NOTICE: The formula is different from previous Radiometer analyzers. The calculation is done in accordance with NCCLS (CLSI)-approved guidelines [24]. However, since it is assumed that the previous method [14] is a better model, the previous range checks are retained (no values displayed outside ±50 mmol/L and values tagged with «?»…
Page 241: Ph(St)

Eq. 13 [15]: Hct = 0.04939ctHb Hct cannot 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 was changed to ensure that Hct=0 when ctHb=0.
Page 242: Po (A)/Fo (I)

8. Parameters ABL90 FLEX reference manual where Description See… 14.1 S = ODC(P,A,T) Eq. 47   14.2 Eq. 46.12  1- MetHb  COHb O ( )= 1- COHb- MetHb 14.3 Eq. 46.10 O ( )= COHb  …
Page 243: Po (A,T)/ Fo (I)

ABL90 FLEX reference manual 8. Parameters (a,T)/ Eq. 18 :  The calculation cannot be performed on the basis of the default FO (I) value, and the calculation requires entering the sample as «Arterial» or «Capillary». Eq. 19 Refer to Eq. 46.10: The ODC is determined as described in equations 46-47 in the section Oxyhemoglobin Dissociation Curve further in this chapter.
Page 244: P50(St)

8. Parameters ABL90 FLEX reference manual p50(st) Eq. 21 : p50 is calculated for pH = 7.40, pCO = 5.33 kPa, FCOHb = 0, FMetHb = 0, FHbF = 0. The ODC is determined as described in equations 46-47 in the section Oxyhemoglobin dissociation curve (ODC), see equation 47 further in this chapter.
Page 245: Cto 2

0.0105 mmol/L/kPa at 37 °C [24]. cannot be calculated on the basis of a default ctHb value. NOTICE: The formula is different from previous Radiometer analyzers. The oxygen solubility coefficient is now changed from 0.00983 to 0.0105 to be in accordance with NCCLS (CLSI)-approved guidelines [24].
Page 246: Q · V O 2

8. Parameters ABL90 FLEX reference manual Eq. 30 [8]: (or c The ODC is determined, as described in equations 46-47 in the section Oxyhemoglobin Dissociation Curve further in this chapter. tO ( )  tO ( )  where Description See……
Page 247: Fshunt

ABL90 FLEX reference manual 8. Parameters FShunt Eq. 34 [5]: tO (c)  tO (a) Shunt= tO (c)  tO (v) Description 34.1 tO (A)  tO (a) Shunt  tO (A)  tO (v) 34.2    tO (a) …
Page 248: Fshunt(T)

8. Parameters ABL90 FLEX reference manual FShunt(T) Eq. 35 [5,16]:    tO (a, )- tO (v, ) Shunt( )= 1    tO (A, )- tO (a, )   where (a,T): total oxygen in arterial blood at patient temperature (A,T): total oxygen in alveolar blood at patient temperature –…
Page 249: Fo Hb

ABL90 FLEX reference manual 8. Parameters Eq. 38 [8]: The ODC is determined as described in equations 46-47 in the section Oxyhemoglobin Dissociation Curve further in this chapter.  tO (a) t  Description See…   38.1  …
Page 250: Fhhb

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 1% in the pH range 7.2-7-6.
Page 251: Po (X,T)

ABL90 FLEX reference manual 8. Parameters In the calculations the following are assumed: pH = 7.4, pCO = 5.33 kPa, FCOHb = 0, FMetHb = 0, cDPG = 5 mmol/L, and temp = 37 °C. Description See… 49.1 An estimate of FHbF is made: FHbF = 0.8…
Page 252: Vco 2 /V(Dry Air)

8. Parameters ABL90 FLEX reference manual The calculation requires entering the sample type as «Arterial» or «Capillary». /V(dry Eq. 51 : air) (dry air)  (amb)  /V(dry air) Eq. 52 : O / (dry air)  (amb) 6.275 …
Page 253: Oxyhemoglobin Dissociation Curve (Odc)

ABL90 FLEX reference manual 8. Parameters Oxyhemoglobin dissociation curve (ODC) ODC equations These equations account for the effect of FCOHb on the shape of the Oxyhemoglobin Dissociation Curve (ODC) in accordance with the Haldane equation. Eq. 46 16,18:  …
Page 254: The Odc Displacement

8. Parameters ABL90 FLEX reference manual The ODC The ODC displacement which is described by «a» and «b» in the coordinate displacement system (ln(s/(1–s)) vs ln(p)), is given by the change in p50 from the default to its actual value in a more common coordinate system (sO…
Page 255: The Actual Odc Position

ABL90 FLEX reference manual 8. Parameters The actual ODC The actual position of the ODC at 37 C for a given sample is, in principle, position determined in two steps: 1. The calculation of the combined effect on the ODC position at 37 C of all known causes for displacement (= ac in equation 46.13), and based on…
Page 256
8. Parameters ABL90 FLEX reference manual Step Description > 0.97 (or erroneous) and p50(st) is known. Coordinates (P ) are calculated from (p50(st), 0.5) using equations 46.9 and 46.11. Reference position of the ODC. The ODC is shifted from the reference position to pass through the point (P ).
Page 257: Coordinates On The Odc

ABL90 FLEX reference manual 8. Parameters Coordinates on Calculation of a set of coordinates on the ODC is symbolized by: the ODC Eq. 47: S = ODC(P, A, T) P = ODC(S, A, T) These equations are symbolic representations of the relationship between saturation (S), tension (P), displacement (A) and temperature (T).
Page 258: Conversion Of Units

8. Parameters ABL90 FLEX reference manual Conversion of units SI units The equations stated above are based on the SI-unit system. If parameters are known in other units, they must be converted into a SI unit before entering the equations. The result will be in an SI unit.
Page 259: Cglu

ABL90 FLEX reference manual 8. Parameters cGlu 22 = 18.016  cGlu (mmol/L) or cGlu (mg/dL) = 0.055506  cGlu (mg/dL) cGlu (mmol/L) cLac 22 = 9.008  cLac (mmol/L) or cLac (mg/dL) = 0.11101  cLac (mg/dL) cLac (mmol/L)
Page 260: Default Values

8. Parameters ABL90 FLEX reference manual Default values Values The following default values are used in the analyzer, if other values are not keyed in. 37.0 °C 0.21 (21.0 %) 0.86 ctHb 9.3087 mmol/L, (15.00 g/dL or 150 g/L) FCOHb 0.004 (0.4 %)
Page 261: References

14. Christiansen TF. An algorithm for calculating the concentration of the base excess of blood. In: Siggaard-Andersen O, ed. Proceedings of the IFCC expert panel on pH and blood gases held at Herlev Hospital 1980. Copenhagen: Radiometer Medical A/S, 1981: 77-81.
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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.
Page 263: Solutions

9. Solutions General information …………….. 9-2 Solutions ………………9-3 Certificate of traceability …………..9-5…
Page 264: General Information

9. Solutions ABL90 FLEX reference manual General information Introduction The ABL90 FLEX analyzer utilizes a solution pack for all calibrations, QC and rinse procedures, and for the collection of waste fluids. Solution pack The solution pack contains eight foil pouches: …
Page 265: Solutions

ABL90 FLEX reference manual 9. Solutions Solutions The solutions contained in the pouches of the solution pack are used for either calibration or quality control of all analytes. During sample analysis and quality control measurements CAL 1 also acts as a rinse solution, removing the sample from the sensor cassette measuring chamber.
Page 266
9. Solutions ABL90 FLEX reference manual Concentration Substance Unit S9030 S9040 S9050 (QC 1) (QC 2) (QC 3) Solution Solution Gas pO Solution (at 760 mmHg) mmHg mmHg (42.07 %) mmol/L mmol/L – mmol/L mmol/L 1.65 cGlu mmol/L cLac mmol/L…
Page 267: Certificate Of Traceability

ABL90 FLEX reference manual 9. Solutions Certificate of traceability…
Page 268
9. Solutions ABL90 FLEX reference manual…
Page 269: 10. Messages

10. Messages List of analyzer messages…………..10-2 10-1…
Page 270: List Of Analyzer Messages

10. Troubleshooting, updated for software version 2.3 ABL90 FLEX reference manual List of analyzer messages Messages on The following messages will be seen on the user and manager levels. The user and messages are listed in numerical order. manager levels Operator actions are listed in order of priority.
Page 271
— Perform QC. If the QC result is accepted, the blood sample may be suspected. — Perform measurement on new blood sample. * The ABL90 FLEX reference manual includes a quality control appendix for manual QC. 10-3…
Page 272
10. Troubleshooting, updated for software version 2.3 ABL90 FLEX reference manual Message Interpretation Operator action Value below The parameter value is below — Check for and remedy reportable range the reportable range. other errors related to the result, system messages or calibration status.
Page 273
ABL90 FLEX reference manual 10. Troubleshooting, updated for software version 2.3 Message Interpretation Operator action LIS/HIS: High- An error occurred while — Check protocol level protocol formatting a message. configurations. could not Contact Radiometer generate high- service representative. level packet…
Page 274
— Check Replacement trend or shift is indicated. Status for pending Patient results should be electrode replacements. considered unreliable until — Refer to ABL90 FLEX the problem is remedied. reference manual for evaluation procedure. Westgard Rule Ten consecutive — Check the electrode (10.x) violation…
Page 275
ABL90 FLEX reference manual 10. Troubleshooting, updated for software version 2.3 Message Interpretation Operator action Automatic The scheduled automatic — No action required. backup backup was completed succeeded successfully. General printer A printer problem has — Check printer paper. error occurred, e.g.
Page 276
10. Troubleshooting, updated for software version 2.3 ABL90 FLEX reference manual Message Interpretation Operator action Temp. error: Temperature in the — Ensure that the Barometer barometer on the Analyzer ambient temperature is Control is outside between 15 and 32 °C.
Page 277
ABL90 FLEX reference manual 10. Troubleshooting, updated for software version 2.3 Message Interpretation Operator action Calibration The sensitivity value is out of — Check for and remedy sensitivity out of range for the given any system messages. range parameter. — Repeat the calibration.
Page 278
10. Troubleshooting, updated for software version 2.3 ABL90 FLEX reference manual Message Interpretation Operator action Liquid transport Liquid transport of Rinse — Check solution pack or error during rinse failed sensor cassette status and replace, if necessary. Removal condition: — Successful Rinse.
Page 279
ABL90 FLEX reference manual 10. Troubleshooting, updated for software version 2.3 Message Interpretation Operator action Inlet LS failed to Inlet liquid sensor failed to — Repeat the liquid calibrate calibrate. sensor calibration. — Contact Radiometer service representative. Sensors LS failed…
Page 280
10. Troubleshooting, updated for software version 2.3 ABL90 FLEX reference manual Message Interpretation Operator action Measured QC The parameter value is — Verify the procedure value higher than above the upper limit of the and repeat the statistical range user-defined statistical measurement.
Page 281
ABL90 FLEX reference manual 10. Troubleshooting, updated for software version 2.3 Message Interpretation Operator action Cal expired (Cl) Too long time passed since — Perform a calibration. the last successful calibration Removal condition: of the parameter. Parameter measurement values are — Successful 2-point reported as «..».
Page 282
10. Troubleshooting, updated for software version 2.3 ABL90 FLEX reference manual Message Interpretation Operator action Barometer error The measured parameter — Contact Radiometer may be unreliable due to service representative. barometer error. OXI module not The OXI module is not…
Page 283
ABL90 FLEX reference manual 10. Troubleshooting, updated for software version 2.3 Message Interpretation Operator action Built-in QC The analyzer was set up to — Check Calibration measurement perform built-in QC Status and remedy any started due to measurements in case of…
Page 284
10. Troubleshooting, updated for software version 2.3 ABL90 FLEX reference manual Message Interpretation Operator action General WSM The data management — Wait a few minutes for exception system establishes the connection to connection to the analyzing establish. unit, or the connection is — Restart the analyzer.
Page 285
ABL90 FLEX reference manual 10. Troubleshooting, updated for software version 2.3 Message Interpretation Operator action Remote operator A remote operator has — No action required. logged on with logged on the analyzer via user: NetOp. Remote operator An operator, remotely logged — No action required.
Page 286
10. Troubleshooting, updated for software version 2.3 ABL90 FLEX reference manual Message Interpretation Operator action locked The parameter has been — Await corrective locked by a RADIANCE actions initiated by the operator, as reflected in the RADIANCE operator. Activity Log.
Page 287
ABL90 FLEX reference manual 10. Troubleshooting, updated for software version 2.3 Message Interpretation Operator action Lac locked The parameter has been — Await corrective locked by a RADIANCE actions initiated by the operator, as reflected in the RADIANCE operator. Activity Log.
Page 288
10. Troubleshooting, updated for software version 2.3 ABL90 FLEX reference manual Message Interpretation Operator action HbF locked The parameter has been — Await corrective locked by a RADIANCE actions initiated by the operator, as reflected in the RADIANCE operator. Activity Log.
Page 289
ABL90 FLEX reference manual 10. Troubleshooting, updated for software version 2.3 Message Interpretation Operator action tHb unlocked The message is used in the — No action required. For Activity Log to indicate that a information only. previously locked parameter has been unlocked.
Page 290
10. Troubleshooting, updated for software version 2.3 ABL90 FLEX reference manual Message Interpretation Operator action Leak currents Leak currents were detected — Replace liquid- or detected during system calibration and sensor cassette. may distort measuring — Contact Radiometer results. service representative.
Page 291
ABL90 FLEX reference manual 10. Troubleshooting, updated for software version 2.3 Message Interpretation Operator action Inhomogeneous Shown in the Activity Log — The analyzer will QC3 solution when «User-intervention automatically enter required» has been entered «User-intervention due to this reason.
Page 292
10. Troubleshooting, updated for software version 2.3 ABL90 FLEX reference manual Message Interpretation Operator action 1009 Unable to Can be shown on a result if — Restart the analyzer. calculate oxygen unable to calculate oxygen — Perform a calibration. parameter…
Page 293
ABL90 FLEX reference manual 10. Troubleshooting, updated for software version 2.3 Message Interpretation Operator action 1018 Oxi electronic Oxi hardware problem. — Restart the analyzer. adjustment error — Perform a calibration. — Contact Radiometer service representative. 1019 Oxi Blank Cal.
Page 294
10. Troubleshooting, updated for software version 2.3 ABL90 FLEX reference manual Message Interpretation Operator action 1031 Oxi initialization Oxi initialization in progress. — Please wait up to 50 in progress minutes before restarting the analyzer. — Restart the analyzer. — Contact Radiometer service representative.
Page 295
ABL90 FLEX reference manual 10. Troubleshooting, updated for software version 2.3 Message Interpretation Operator action 1065 Temperature in Hardware temperature error. — Ensure that the sensor cassette ambient temperature is bottom out of between 15 and 32 °C. range — If the system has just…
Page 296
10. Troubleshooting, updated for software version 2.3 ABL90 FLEX reference manual Message Interpretation Operator action 1080 Installed sensor This message is shown in the — No action required. For cassette was not Activity Log when a sensor information only. registered as…
Page 297
ABL90 FLEX reference manual 10. Troubleshooting, updated for software version 2.3 Message Interpretation Operator action 1093 No cal 3 solution Shown in the Activity Log — The analyzer will when «User-intervention automatically enter required» has been entered «User-intervention due to this reason.
Page 298
10. Troubleshooting, updated for software version 2.3 ABL90 FLEX reference manual Message Interpretation Operator action 1112 LS inlet not Shown in the Activity Log — The analyzer will empty when «User-intervention automatically enter required» has been entered «User-intervention due to this reason.
Page 299
ABL90 FLEX reference manual 10. Troubleshooting, updated for software version 2.3 Message Interpretation Operator action 1125 An unregistered This message is shown in the — No action required. For and used sensor Activity Log after a sensor information only. was installed cassette replacement.
Page 300
10. Troubleshooting, updated for software version 2.3 ABL90 FLEX reference manual Message Interpretation Operator action 1147 Inlet opened Shown in the Activity Log — The analyzer will during rinse when «User-intervention automatically enter required» has been entered «User-intervention due to this reason.
Page 301
ABL90 FLEX reference manual 10. Troubleshooting, updated for software version 2.3 Message Interpretation Operator action 1167 Sensor cassette Shown in the Activity Log — The analyzer will not properly when «User-intervention automatically enter installed required» has been entered «User-intervention due to this reason.
Page 302
10. Troubleshooting, updated for software version 2.3 ABL90 FLEX reference manual Message Interpretation Operator action 1175 Sensor Hardware temperature error — Ensure that the temperature (Thermistor). ambient temperature is error between 15 and 32 °C. — If the system has just…
Page 303
ABL90 FLEX reference manual 10. Troubleshooting, updated for software version 2.3 Message Interpretation Operator action 1184 Leak detected Shown in the Activity Log — The analyzer will when «User-intervention automatically enter required» has been entered «User-intervention due to this reason.
Page 304
10. Troubleshooting, updated for software version 2.3 ABL90 FLEX reference manual Message Interpretation Operator action 1195 ABL not The analyzer was refused — Enter the correct connected to QA connection to the QA Portal password in the Portal — incorrect due to incorrect password.
Page 305
ABL90 FLEX reference manual 10. Troubleshooting, updated for software version 2.3 Message Interpretation Operator action 1216 Lifetime in Shown in the Activity Log — The analyzer will analyzer when «User-intervention automatically enter exceeded required» has been entered «User-intervention due to this reason.
Page 306
10. Troubleshooting, updated for software version 2.3 ABL90 FLEX reference manual Message Interpretation Operator action 1223 Analyzer did not The analyzer DMS has not — Restart the analyzer. connect at start- been able to establish — Contact Radiometer contact to the WS(M) at service representative.
Page 307
ABL90 FLEX reference manual 10. Troubleshooting, updated for software version 2.3 Message Interpretation Operator action 1297 Printer is offline The printer is offline due to — Check the power either a bad or missing connection power / USB connection — Check the USB…
Page 308
10. Troubleshooting, updated for software version 2.3 ABL90 FLEX reference manual Message Interpretation Operator action 1310 Response error Sensor (Metabolite) does not — Replace sensor work properly 1311 The analyzer chip It’s not possible to read or — Contact Radiometer…
Page 309
ABL90 FLEX reference manual 10. Troubleshooting, updated for software version 2.3 Message Interpretation Operator action 1326 Sensor Shown in the Activity Log — The analyzer will thermistor when «User-intervention automatically enter recalibration required» has been entered «User-intervention failed — due to this reason.
Page 310
10. Troubleshooting, updated for software version 2.3 ABL90 FLEX reference manual 10-42…
Page 311
I Appendix — Quality control General information …………….I-2 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………………
Page 312: General Information

ABL90 FLEX reference manual General information This appendix includes general information about quality control/quality management that is 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.
Page 313: Statistical Parameters

ABL90 FLEX reference manual Appendix – Quality control Statistical parameters This section describes the terms and statistical parameters used in the topic quality control: Parameter Definition Mean value, The mean value is the average value as shown below:  …
Page 314: Control Ranges (For Manual Qc Only

 analyzer-to-analyzer  dispenser-to-dispenser  lot-to-lot  variation from calibration solutions, etc. are included in the control ranges. Definitions The following terms are used by Radiometer in connection with control ranges: Term Explanation At Radiometer True value The value of a…
Page 315: User Control Ranges (For Manual Qc Only

ABL90 FLEX reference manual Appendix – Quality control Term Explanation At Radiometer Assigned value The center value of a When a quality control system is control range. developed, it is tested on 10 well- functioning analyzers of the type for…
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ABL90 FLEX reference manual User control ranges (for manual QC only) Introduction The specified control ranges in the inserts, which are established by Radiometer, include all well-functioning analyzers, and the uncertainty budget will therefore include a contribution derived from the analyzer-to-analyzer variation. This means that results obtained on one specific analyzer should fall within control ranges that are narrower than the insert control ranges.
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ABL90 FLEX reference manual Appendix – Quality control To correct the 2 SD control ranges for the above contributions, do the following: Step Action Find the mean ( X ) and the two times standard deviation (2 SD) value in the Quality Control log (press: Data Logs > Quality Control Log >…
Page 318
Appendix – Quality control ABL90 FLEX reference manual c Ca mmol/L 0.020  c Cl mmol/L 1.16 c Glu mmol/L c Lac mmol/L c tBil mol/L c tHb g/dL 0.13 F HbF % Other Hb derivatives % 0.36 Level 3…
Page 319: Statistics Factor And Statistics Range

ABL90 FLEX reference manual Appendix – Quality control c tHb g/dL 0.06 F HbF % Other Hb derivatives % Statistics factor and statistics range Definitions Normal statistical variation implies that 95.5 % of all quality control results obtained on a well-functioning analyzer falls within  2 SD range, and 99.7 % falls within …
Page 320: Temperature Corrections (For Manual Qc Only

 where  = higher values, and  = lower values. Radiometer recommends that ampoules that have been stored in a cool place are conditioned at a known room temperature for at least 5 hours before a measurement, and we strongly advise not to keep ampoules on the top of an analyzer as the temperature there can vary.
Page 321: Temperature Corrections For Ph, Pco And Po

Appendix – Quality control Temperature Range+ QUALICHECK solutions (usable for e.g. Calibration verification, see corrections for section Calibration verification in Chapter 6: Calibration in the ABL90 FLEX pH, pCO operator’s manual). Parameter Equation for temperature correction pH(corr. to 25 C) = pH(meas.)  A(t  25) p CO (corr.
Page 322: Westgard Rules

Appendix – Quality control ABL90 FLEX reference manual Westgard rules About The Westgard rules are a set of statistical rules that, when applied to the quality Westgard rules control results, can aid the following:  Increase the probability of detecting an error on the analyzer by analyzing the quality control measurements …
Page 323: Rule 1 2S

ABL90 FLEX reference manual Appendix – Quality control Rule 1 This rule is a warning rule. Measurement value is outside the mean  2 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.
Page 324: Rule R

Appendix – Quality control ABL90 FLEX reference manual Rule R This rule is a rejection rule. The difference between two consecutive measurements exceeds 4 This indicates inconsistency in your procedures or an unstable analyzer. Corrective action: Perform steps described in section Quality control evaluation further in this appendix.
Page 325: Evaluation Procedure

(Each QC ampoule must be used immediately after being opened, for one measurement on one analyzer only, in order to ensure the reliability of the measurement). Did you use Radiometer QUALICHECK adapter? If own user-defined limits were entered: Did you enter too narrow control ranges? If everything is OK –…
Page 326
Appendix – Quality control ABL90 FLEX reference manual I-16…
Page 327: Appendix — Traceability To The Primary Standards At Radiometer

II Appendix — Traceability to the primary standards at Radiometer…
Page 328: Introduction

Appendix – Traceability to the primary standards at Radiometer ABL90 FLEX reference manual Introduction The Metrology Section at Radiometer is responsible for establishing metrological – traceability for the parameters pH, pCO , pO , cK , cNa , cCa , cCl…
Page 329: Traceability

ABL90 FLEX reference manual Appendix – Traceability to the primary standards at Radiometer Traceability The primary pH standards are traceable to the definitive method for pH. The definitive method is based on a Hydrogen Electrode System. The primary pH standards are obtained from the Danish primary laboratory for Electrochemistry (DPLEC) at the Danish Institute of Fundamental Metrology (DFM).
Page 330: Cca

Appendix – Traceability to the primary standards at Radiometer ABL90 FLEX reference manual The primary standards used are the so-called Ca transfer standards, produced ® from CaCO Urtitersubstanz , produced by Merck. The transfer standards are pH-stabilized to pH = 7.4, with 1 mmol/L HEPES and an ionic strength of 160.0 mmol per kg.
Page 331
ABL90 FLEX reference manual Appendix – Traceability to the primary standards at Radiometer Saturation – The primary working standard used is a whole-blood sample, with the ctHb = 100 % value adjusted to between 13 and 15 g %. The blood sample is tonometered with 5.6 % CO…
Page 332
Appendix – Traceability to the primary standards at Radiometer ABL90 FLEX reference manual Radiometer measurements The Hct measurement is based on conductivity measured in a sample and then corrected for the presence of sodium ions. A Sigma 201 Micro hematocrit…
Page 333
ABL90 FLEX reference manual Appendix – Traceability to the primary standards at Radiometer References Measurement of pH. Definition, standards, and procedures. (IUPAC Recommendations 2002). Pure and Appl Chem 2002; 74, 11: 2169-2200. Standardization of sodium and potassium ion selective electrode systems to the flame photometric method.
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Appendix – Traceability to the primary standards at Radiometer ABL90 FLEX reference manual II-8…
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Index Absorbance……………………….5-41 total………………………… 5-41 Access profiles ……………………..1-8 8-19 Acoustic signal setup……………………1-49 Activity vs concentration……………………5-3 Adding a Note ……………………..1-46 Adding a user activity……………………1-37 Age group limits, setting ……………………. 1-13 I-12 Amperometry ………………………. 5-3 Analysis setup ……………………..1-10 age group limits ………………………
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Calibration……………………..3-7, 5-4 calibration equation ……………………5-6 calibration line……………………..5-6 Calibration schedule setup………………….1-22 general information ……………………5-5 metabolite sensors ……………………5-34 optical system ……………………..5-44 Oxi calibration……………………..3-7 sensor……………………..5-26 , cGlu, cLac calibration………………….3-7 pH sensor……………………….. 5-20 – pH, cK , cNa , cCa , cCl…
Page 337
……………………….1-75 miscellaneous setup ……………………1-76 parameter setup……………………..1-73 printer setup……………………..1-76 quality control setup ……………………1-72 Radiometer default setup ………………….1-70 replacement setup ……………………1-73 setup ……………………….1-70 units ……………………….. 1-74 user-defined notes……………………1-75 user-defined patient data items ………………..1-74 Default values……………………..
Page 338
sample mixer ……………………..4-4 sensor Interface……………………..4-3 sensor module……………………..4-3 user interface module ……………………4-3 wet section control……………………. 4-3 Equation calibration……………………….5-6 Equation list……………………….. 8-23 Evaluation — acceptance status ………………….I-15 Exporting archives……………………..2-8 Exporting data logs……………………..2-7 General measuring principles ………………….5-3 General Security ……………………..
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electrolytes ……………………..5-21 oximetry parameters ……………………5-47 restrictions ……………………… 5-48 Measuring principles general ……………………….5-3 metabolite sensors ……………………5-36 pCO2 sensor ……………………..5-24 pH and electrolyte sensors………………….5-18 pO2 sensor……………………… 5-29 Measuring processes…………………….. 3-4 Menu setup ………………………… 1-3 Messages ……………………….10-1 Metabolite sensors………………………
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disabling ……………………….1-41 enabling ……………………….1-41 general information ……………………8-2 input parameters …………………….. 8-13 list of equations ……………………… 8-23 locking……………………….1-42 measured parameters ………………….8-5, 8-6 The Deep Picture ……………………… 8-2 unlocking……………………….. 1-42 Parameters and input setup ………………….1-41 Password ……………………….1-5 Patient data user-defined items ……………………
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QC solution ………………….1-25 editing the QC schedule………………….. 1-26 Quality control setup ……………………1-23 Quality Management ……………………. 5-9 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………………..
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QA Portal connection setup………………….1-59 QC input ……………………….1-28 QC ranges………………………. 1-26 QC statistics……………………..1-29 quality control……………………..1-23 RADIANCE connection ………………….1-52 Radiometer default ……………………1-70 reference ranges……………………… 1-12 replacement ……………………..1-35 replacement schedule……………………1-35 replacement warnings ……………………1-40 reportable ranges ……………………. 1-15…
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Total absorbance……………………..5-41 Total analytical error ……………………. 7-5 Traceability certificate……………………9-5 Traceability of calibration solutions ………………..5-5 Traceability to the primary standards at Radiometer ……………. II-1 Troubleshooting……………………..10-1 Unit conversion ……………………..8-42 Units setup……………………….1-43 Updating control ranges ……………………1-28…
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User activities……………………..1-37 adding……………………….1-37 deleting ……………………….1-38 editing……………………….1-38 User control ranges……………………..I-6 User interface module Electronics……………………….. 4-3 User-defined corrections ……………………6-1 entering……………………….6-3 general information ……………………6-2 slope and offset……………………..6-4 User-defined notes……………………… 1-46 adding……………………….1-46 deleting ……………………….1-46 editing……………………….
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ABL90 FLEX reference manual Date of issue Date of issue Radiometer representative: Manufacturer: Radiometer Medical ApS Åkandevej 21 If you have any questions 2700 Brønshøj or need assistance, Denmark please contact your local www.radiometer.com Radiometer representative. ABL90 FLEX reference manual — from software version 2.3…
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Date of issue ABL90 FLEX reference manual…

Источник

Дата вступления в силу 14 мая 2018 года

В настоящем Онлайн-уведомлении о соблюдении конфиденциальности (далее — «Политика конфиденциальности») описаны применяемые нами процедуры обработки Персональных данных, передаваемых нам с помощью наших веб-сайтов, мобильных сайтов, мобильных приложений и прочих цифровых технологий и средств, находящихся под контролем компании Радиометер, Radiometer Medical ApS, Åkandevej 21, 2700 Brønshøj, Denmark, которые относятся к настоящей Политике конфиденциальности (далее вместе — «Сайты компании Радиометер»). При обработке Персональных данных компания Радиометер является стороной, контролирующей данные, согласно действующему законодательству.
Политика конфиденциальности не имеет силы в отношении Сайтов компании Радиометер, которые не связаны с настоящей Политикой конфиденциальности или веб-сайтами третьих сторон, ссылки на которые содержатся на Сайтах компании Радиометер.

Виды информации, которые мы собираем в режиме онлайн

Типы Персональных данных, сбор которых мы можем проводить в ходе использования Вами Сайтов компании Радиометер, представлены в этом разделе, и включают как информацию, которую Вы передаете нам, так и информацию, сбор которой мы проводим автоматически в ходе использования вами Сайтов компании Радиометер.

В контексте настоящего Уведомления о соблюдении конфиденциальности, понятие «Персональные данные» означает информацию, содержащую сведения о Вашей личности, или которую можно использовать для установления Вашей личности. В качестве примера Персональных данных можно привести фамилию, адрес, номер телефона и адрес электронной почты.

Информация, которую Вы предоставляете

Чтобы получить подробную информацию, опубликованную на Сайтах компании Радиометер, Вам не обязательно регистрироваться для получения услуг или участия в программах. Однако некоторый контент доступен только зарегистрированным или идентифицируемым пользователям, и для получения доступа к услуге Вам придется создать профиль или указать конкретную информацию о себе.

Персональные данные, которые Вы предоставляете при посещении Сайтов компании Радиометер

Компания Радиометер собирает Персональные данные, которые Вы указываете на Сайтах компании Радиометер, например, при покупке продукта, для получения выпущенных на рынок продуктов и информации, при обращении в Отдел обслуживания пользователей компании Радиометер или при заполнении опросников и анкет компании Радиометер. Это может включать следующее:

Контактную информацию, например, Ваша фамилия, адрес, номер телефона или адрес электронной почты
Регистрационную информацию, например, имя пользователя или пароль
Информацию об оплате, когда Вы оказываете компании Радиометер услуги в сфере своей компетенции, как медицинский работник
Сведения о трудоустройстве, образовании и прочая исходная информация, если Вы подаете заявку на трудоустройство в компанию Радиометер
Информацию о платежах (например, банковская информация, номер платежной карты, срок действия, адрес доставки и адрес приема платежей)
Контент, который Вы можете предоставлять (например, при заполнении нашей онлайн-формы для связи или при отправке другой информации).

Персональные данные, которые Вы указываете в ходе других контактов с компанией Радиометер

Вы можете обращаться в компанию Радиометер с вопросами, для обсуждения опасений или информирования о проблемах, связанных с нашими продуктами. Если Вы предоставляете или запрашиваете информацию у компании Радиометер, Вас могут попросить предоставить Вашу контактную информацию, а также любые Персональные данные, имеющие отношение к Вашему запросу.
Информация, сбор которой может проводиться автоматически
При использовании Вами Сайтов компании Радиометер мы также можем автоматически проводить сбор определенной информации о пользовании функциями и об используемом устройстве, как описано ниже.

IP-адрес

Мы можем сохранить IP-адрес (интернет-протокол) Вашего компьютера или другого электронного устройства, когда Вы посещаете Сайты компании Радиометер. IP-адрес позволяет идентифицировать используемое Вами электронное устройство для посещения Сайтов, и мы можем использовать его для поддержки связи с Вашим компьютером в ходе Вашей навигации по Сайтам компании Радиометер и для предоставления персонализированного контента.

Файлы cookie и прочие технологии отслеживания

Мы также проводим сбор информации о посещении Вами Сайтов компании Радиометер с помощью технологий отслеживания, например, файлов cookie и веб-маячков. Файлы cookie — это уникальный цифровой код, который сохраняется на Вашем компьютере для того, чтобы запомнить Ваши интересы и предпочтения, и для того, чтобы система автоматически узнала Вас при следующем Вашем посещении. Веб-маячок — прозрачное графическое изображение на веб-сайте, электронном или рекламном сообщении, которое позволяет отслеживать, например, действия пользователя и число посещений сайта. С помощью таких технологий система запоминает Ваши предпочтения и позволяет предоставлять Вам контент и функции, которые с высокой долей вероятности вызовут Ваш интерес, на основании данных истории посещений, которые включают информацию о предыдущих Ваших посещениях Сайтов компании Радиометер.
Мы используем технологии Google Display Advertising (например, Retargeting с Google Analytics, Google Display Network Impression Reporting, DoubleClick Campaign Manager integration и Google Analytics Demographics и Interest Reporting), чтобы (1) предложить Вам наши рекламные материалы на наших веб-сайтах, на основании Ваших предыдущих посещений Сайтов компании Радиометер, и (2) лучше изучить результаты нашей рекламной деятельности и использования рекламных услуг. В связи с применением технологий Google Analytics Demographics и Interest Reporting, мы можем использовать сведения, извлеченные из данных Google по персонализированной рекламе или данных о целевой аудитории (например, возраст, пол и сфера интересов), с применением технологии Google Analytics, для подробного анализа ситуации и усовершенствования наших маркетинговых программ и контента Сайта.

Некоторые виды нашей онлайн-рекламы реализованы с помощью Google Display Advertising. В комплексе этой программы мы используем функции Google Analytics, например, Retargeting. С помощью таких функций и прочих возможностей, предлагаемых рекламными сетями, мы и операторы рекламных сетей, в числе которых Google, можем использовать файлы cookie третьих сторон (например, файл cookie DoubleClick), а также, в ряде случаев, файлы cookie первой стороны (например, файлы cookie Google Analytics), для информирования, оптимизации и обслуживания рекламных материалов в сети Интернет на основании истории посещений пользователем Сайтов Компании Радиометер. Также при посещении Вами Сайтов компании Радиометер мы можем демонстрировать Аам рекламные материалы некоторых наших аффилированных компаний.

Чтобы отказаться от услуг Google Ads, посетите ресурс http://www.google.com/ads/preferences. Если Вы не желаете, чтобы Ваши данные использовались службами Google Analytics, Вы можете установить дополнение для интернет-обозревателя с блокировкой Google Analytics, перейдя по ссылке на блокировщик Google Analytics.
На Сайтах компании Радиометер не применяется функция «не отслеживать» сигналы, которые передает интернет-обозреватель.
Дополнительная информация о файлах cookie и прочих технологиях отслеживания, в том числе сведения о том, как запретить эти функции, rel=»noopener noreferrer» приведена на странице http://www.allaboutcookies.org/. Примите к сведению, что некоторые файлы cookie являются обязательными для функционирования наших Сайтов, и их удаление или блокировка ограничит функциональность сайта.

Отслеживание мобильных данных

Доступ к некоторым Сайтам компании Радиометер осуществляется посредством мобильных приложений или мобильных сайтов, которые Вы можете использовать на Вашем мобильном устройстве. Если для доступа к Сайтам компании Радиометер Вы используете мобильное устройством, мы в дополнение к описанным выше сведениям можем проводить сбор следующей мобильной информации: идентификатор устройства или рекламного материала, тип устройства, тип оборудования, MAC-адрес (контроль доступа к носителю информации), IMEI (международный идентификатор оборудования мобильной связи), версия Вашей операционной системы, платформа, используемая для доступа или загрузки Сайта Компании Радиометер (напр., Apple, Google, Amazon, Windows), информация о географическом положении и использовании Вашего устройства, и о пользовании Вами Сайтов компании Радиометер.

Информация, поступающая из других источников

Мы можем объединять Вашу информацию, полученную в ходе посещения Сайта компании Радиометер, с Вашей информацией, полученной при посещении Сайтов другой компании Радиометер. Также мы можем объединять Вашу информацию, собранную с помощью Сайтов компании Радиометер, с информацией, которую мы получили в режиме офлайн, а также с информацией, предоставленной нам третьими сторонами.

Как мы используем Вашу информацию

Мы используем Ваши Персональные данные для предоставления Вам запрашиваемых Вами продуктов и услуг, обмена информацией с Вами, предоставления Вам возможности более эффективно использовать Сайты компании Радиометер, общего усовершенствования наших продуктов и услуг, а также в других внутренних бизнес-целях. Такие виды использования могут включать запись, организацию, классификацию, хранение, адаптацию или изменение, извлечение, консультацию, использование, раскрытие посредством передачи, распространения или другими способами, согласование или объединение, наложение ограничений, удаление или уничтожение Персональных данных. Персональные данные, которые мы собираем о Вас, могут храниться в течение пяти лет с момента нашего последнего контакта с Вами, после чего они будут переданы в архив для хранения в течение разумного срока в целях, указанных выше, в соответствии с действующим законодательством.

Предоставление запрашиваемых Вами продуктов и услуг

Если Вы решите приобрести продукт или наши услуги, мы используем Персональные данные, которые Вы передали с помощью Сайтов компании Радиометер, для обработки Ваших запросов и счетов, проведения платежей, ответов на Ваши вопросы, предоставления Вам запрашиваемых Вами услуг и максимально эффективного обслуживания Вас как клиента.

Маркетинг

Также вы можете получить от компании Радиометер и соответствующих аффилированных лиц маркетинговую информацию, например, предложения касательно продуктов или услуг компании Радиометер, приглашения принять участие в опросах по нашим продуктам, или уведомления о специальных предложениях. В таких случаях для отправки Вам маркетинговой информации мы будем использовать Вашу контактную информацию и прочие Персональные данные.

Персонализированное взаимодействие с пользователем

Предоставленные Вами Персональные данные могут быть использованы для создания персонализированных предложений, предоставления информации или оказания специальных услуг, исходя из Ваших интересов и предпочтений. Также мы можем использовать Ваш IP-адрес и данные, полученные автоматически в ходе применения файлов cookie и прочих технологий отслеживания, чтобы сделать проще использование Сайтов компании Радиометер и навигацию по ним, а также персонализировать контент, отображаемый на Сайтах компании Радиометер, посредством предоставления информации и услуг, которые могут Вас заинтересовать.

Бизнес и улучшение качества продукта

Для получения новых сведений, которые могли бы помочь компании Радиометер лучше понять потребности клиентов и способствовать улучшению, разработке и оценке продуктов, услуг, материалов и программ. Компания Радиометер проводит анализ предоставленной Вами информации. При этом компания Радиометер не использует информацию, с помощью которой можно установить Вашу личность.

Аналитика и усовершенствование сайта

Мы можем использовать информацию, предоставленную Вами, а также собранную автоматически, об использовании Вами Сайтов компании Радиометер, для отслеживания истории посещений пользователя и оценки его предпочтений в целях усовершенствования, аналитики и оптимизации сайта.

Правовая основа для обработки данных

Согласно Европейским законам по защите данных, в компании Радиометер должна быть правовая основа для обработки Ваших Персональных данных. Правовая основа, применяемая в определенной ситуации, будет зависеть от того, в каких конкретных целях, описанных выше, компания Радиометер будет проводить обработку Ваших Персональных данных:

В ряде случаев компания Радиометер может попросить Вашего согласия на сбор и обработку Ваших Персональных данных. Если Вы решите дать согласие, Вы впоследствии можете отозвать его, обратившись к нам согласно процедуре, представленной в разделе «Ваш выбор правил конфиденциальности». Примите к сведению, что отзыв согласия не повлияет на уже обработанные данные.
В других случаях обработка Ваших Персональных данных может быть обязательным условием для соблюдения требований действующих законов или постановлений, или для выполнения обязательств согласно договору, предметом которого Вы являетесь. Вы не сможете запретить такую обработку данных, или Ваш запрет на обработку таких данных может повлиять на нашу способность выполнить договорные обязательства, которые мы имеем перед Вами иным образом.
Также возможны случаи, когда компания Радиометер может осуществлять обработку Ваших персональных данных на основании законных интересов компании Радиометер, посредством обмена с Вами информацией о наших продуктах и услугах, а также о научных исследованиях и образовательных возможностях. Вы имеете право не дать согласие на такую обработку Ваших Персональных данных. Для этого Вам необходимо обратиться к нам согласно процедуре, представленной в разделе «Ваш выбор правил конфиденциальности».

Информация, которую мы передаем

Мы передаем Ваши Персональные данные только третьим сторонам, как указано ниже. Мы не продаем и не даем в пользование Персональные данные третьим сторонам для их использования в маркетинговых целях.

Рекламные сообщения третьей стороны и поведенческая интернет-реклама

Вам могут демонстрировать онлайн-рекламу продуктов и услуг компании Радиометер на веб-сайтах третьих сторон и в мобильных сервисах, с учетом Ваших предпочтений, например, на основании информации, передаваемой Вами на сайт компании Радиометер или третьей стороны при его посещении, или на основании истории посещений, покупок или интересов. Эти типы индивидуальной онлайн-рекламы могут реализоваться через различные источники, например:

Мы можем передавать нашим поставщикам рекламных услуг Вашу информацию, за исключением информации, позволяющей установить Вашу личность, которую мы получили с помощью файлов cookie и других технологий отслеживания на наших Сайтах компании Радиометер.
Некоторые Сайты компании Радиометер принимают участие в программах поведенческой онлайн-рекламы (иногда ее называют целенаправленной рекламой или персонализированной интернет-рекламой). Вы можете ознакомиться с этими сайтами по ссылке «Выбор рекламы» внизу страницы. Наша сеть рекламных партнеров может сохранять и использовать файлы cookie на веб-сайтах компании Радиометер и веб-сайтах третьей стороны для сбора информации о Вашей активности в целях демонстрации Вам онлайн-рекламы, основанной на Ваших интересах. При демонстрации Вам поведенческой онлайн-рекламы компании Радиометер Вы увидите пиктограмму «Выбор рекламы». По этой пиктограмме или ссылке Вы можете перейти на веб-сайт, на котором можно настроить или запретить использование данных об истории посещений, которые применяют в целях поведенческой онлайн-рекламы. Если Вы запретите это, демонстрация онлайн-рекламы может осуществляться и в дальнейшем, в том числе демонстрация рекламы компании Радиометер, которая основана на другой информации (например, не столько на предшествующей истории посещений, сколько на содержании просмотренной страницы). В ряде случаев сбор данных о Вашей истории посещений может продолжаться сторонними рекламными компаниями, но они не будут использовать эти данные для демонстрации рекламы, основанной на Вашей истории посещений онлайн-ресурсов. Чтобы запретить это, перейдите по ссылке.
Некоторые интернет-обозреватели могут передавать веб-сайтам, с которыми они обмениваются информацией, сигнал «не отслеживать». По состоянию на Дату вступления в силу настоящего Уведомления о соблюдении конфиденциальности, отраслевые стандарты, регулирующие реакцию на такие сигналы, еще не были разработаны. Соответственно, компания Радиометер в настоящее время не реагирует на эти сигналы. Как уже сказано выше, Вы можете отказаться от рекламы, при подборе которой использована Ваша история посещений, в целях поведенческой онлайн-рекламы, перейдя на страницу Выбор рекламы.

Аффилированные лица, продавцы и поставщики

Мы поддерживаем контакт с поставщиками и аффилированными компаниями, которые оказывают нам содействие в ведении нашего бизнеса, и которым может понадобиться доступ к Вашим Персональным данным в целях оказания услуг компании Радиометер. Мы не даем права этим сторонам использовать Персональные данные в каких-либо целях, не имеющих отношения к бизнес-деятельности компании Радиометер и ее соответствующих аффилированных лиц, и не передаем Персональные данные, поступившие из стран, в которых требуется согласие, если только заблаговременно не было получено согласие на передачу данных соответствующим аффилированным лицам. Мы требуем от них обрабатывать собранные у Вас Персональные данные в соответствии с Уведомлением о соблюдении конфиденциальности.

Межбрендовые сайты

Мы можем заключить партнерство с другими компаниями на предоставление Вам информации или услуг на основании совместной «межбрендовой» деятельности. Посетив межбрендовый сайт, Вы можете видеть на Вашем экране логотип компании Радиометер и логотип межбрендового партнера. Вам следует ознакомиться с политикой конфиденциальности межбрендовых партнеров, поскольку они в некоторых аспектах могут отличаться от нашей политики. Ознакомившись с этими политиками, Вы сможете принять информированное решение о том, следует ли передавать информацию на определенный сайт.

Отчеты о продуктах

Если Вы обратитесь к компании Радиометер с информацией об использовании какого-либо нашего продукта, мы можем использовать предоставленную Вами информацию в целях подготовки отчета для уполномоченного государственного регуляторного органа, в соответствии с требованиями законодательства.

При определенных обстоятельствах от компании Радиометер могут требовать раскрыть Ваши Персональные данные согласно правовым обязательствам или требованиям, например, для соблюдения обязательств по отчетности перед государственными регуляторными органами по вопросам безопасности продукта, или в связи с продажей или наших производственных участков или подразделений, что включает услуги, оказываемые посредством одного или нескольких Сайтов компании Радиометер. При таких обстоятельствах мы предпримем меры, чтобы защитить Ваши Персональные данные в максимально возможном объеме. Также мы оставляем за собой право использовать Персональные данные для расследования и привлечения к ответственности пользователей, которые нарушают наши правила, или занимаются деятельностью, которая является незаконной или наносит ущерб другим сторонам или их имуществу.

Организационные изменения

Если компания Радиометер решит провести реорганизацию или закрытие нашей деятельности посредством продажи, слияния или приобретения, компания Радиометер может передать Ваши Персональные данные соответствующим фактическим или будущим покупателям. Мы налагаем на любых фактических или будущих покупателей обязательства по соблюдению положений настоящего Уведомления при обработке этих Персональных данных.

Конфиденциальность данных детей

Компания Радиометер не осуществляет намеренного сбора или использования Персональных данных, полученных непосредственно от детей с помощью Сайтов компании Радиометер (с точки зрения Danaher, детьми являются все несовершеннолетние, не достигшие 18 лет). Наши правила запрещают детям заказывать наши продукты, обмениваться с нами информацией или пользоваться какими-либо нашими онлайн-услугами. Если у Вас есть ребенок, и Вам станет известно, что он предоставлял нам информацию, свяжитесь с нами одним из перечисленных ниже способов, и мы совместно с Вами решим этот вопрос.

Ваш выбор правил конфиденциальности

Вы имеете право ознакомиться и получить копию Ваших Персональных данных, которые хранятся у нас, а также обратиться к нам для исправления неточностей или упущений в Ваших Персональных данных. Вы имеете право получить данные, которые Вы предоставили нам, в машиночитаемом формате, и передать эти данные другой контролирующей стороне. Также Вы можете требовать удаления Ваших Персональных данных, или наложения ограничения на их обработку, или возразить против обработки Ваших персональных данных. Если возникнет необходимость в получении доступа к Вашим Персональным данным, в подаче жалобы, претензии или запроса на исправление, или для отказа от участия в определенных программах, обратитесь в наш Отдел по вопросам конфиденциальности по ссылке «Контакты» на сайте компании Радиометер, услугами которой вы пользуетесь, или воспользуйтесь контактной информацией компании Радиометер в мобильном приложении, которым Вы пользуетесь, или отправьте нам электронное сообщение по адресу dataprivacy@radiometer.dk. Также Вы можете отправить письмо на следующий адрес:
Название Компании: Радиометер
К вниманию: Отдел по вопросам конфиденциальности
Radiometer Medical ApS
Att: Legal & Compliance (Privacy)
Åkandevej 21
2700 Brønshøj
Denmark

Органы РФ по защите данных несут ответственность за соблюдение законов по защите данных в РФ. Для получения дополнительной информации о Ваших правах на неприкосновенность частной жизни, или в случае, если Вам не удалось разрешить вопрос непосредственно с нами, и Вы желаете подать жалобу, обращайтесь по адресу: privacy@radiometer.dk.

Передавая информацию Компании Радиометер, не забывайте указать Ваш адрес электронной почты, адрес веб-сайта, мобильное приложение и/или определенный продукт Компании Радиометер, по которому Вы передаете Персональные данные (напр., radiometer.com), и подробно поясните Ваш запрос. Если Вы пожелаете удалить, обновить или исправить Ваши Персональные данные, и обращаетесь к нам по электронной почте, в тему электронного сообщения включите фразы «Deletion Request» (запрос на удаление) или «Amendment/Correction Request» (запрос на обновление/исправление). Мы своевременно дадим ответ на все разумные запросы, и не исключено, что при обработке определенных запросов нам потребуется дополнительно подтвердить Вашу личность.

Безопасность данных

Компания Радиометер применяет разумные средства технического, административного и физического контроля для защиты любых Персональных данных, полученных посредством Сайтов компании Радиометер. Однако всегда присутствует риск того, что неуполномоченная третья сторона может вмешаться в передачу данных в сети Интернет, либо кто-то найдет способ отключить наши системы защиты. При передаче Персональных данных по сети Интернет, особенно Вашей информации финансового характера, мы настоятельно рекомендуем Вам проявлять осмотрительность. Компания Радиометер не может гарантировать того, что неуполномоченная третья сторона не получит доступ к Вашим Персональным данным; соответственно, передавая Персональную информацию на Сайты компании Радиометер Вам следует тщательно взвешивать выгоду и риск.

Сторонние сайты и плагины социальных сетей

Политика конфиденциальности не имеет силы в отношении Сайтов компании Радиометер, которые не связаны с настоящим Уведомлением о соблюдении конфиденциальности или веб-сайтами третьих сторон, ссылки на которые содержатся на Сайтах компании Радиометер. На Сайтах компании Радиометер могут применяться плагины социальных сетей (напр., кнопка «Нравится» сети Facebook, кнопка «Поделиться в Twitter»), чтобы упростить передачу информации другим. При посещении Сайтов компании Радиометер оператор плагина социальной сети может сохранять на Вашем компьютере или другом электронном устройстве файл cookie, с помощью которого оператор сможет определить пользователей, ранее посещавших наш Сайт. Если при посещении нашего Сайта компании Радиометер Вы перейдете на веб-сайт социальной сети (напр., Facebook, Twitter), веб-сайт социальной сети с помощью этого плагина получит информацию о том, что Вы раньше посещали наш Сайт компании Радиометер. Плагин социальной сети также позволит веб-сайту социальной сети распространять среди других пользователей этого веб-сайта социальной сети информацию о Ваших действиях на нашем Сайте компании Радиометер. Такие параметры распространения данных определены веб-сайтом социальной сети, и основаны на ее политике конфиденциальности.

Всемирный доступ к нашим сайтам

Владельцем и администратором этого сайта в США является компания Радиометер, но предоставляемая вами информация будет доступна для наших аффилированных лиц, продавцов и поставщиков в других странах, согласно положениям настоящей политики. Кроме того, если Вы посетите этот сайт, находясь за пределами США, обмен сведениями с нами в конечном итоге приведет к трансграничной передаче информации. В разных странах применяется различный уровень правовой защиты Персональных данных; однако для безопасности Вашей информации мы предпримем меры защиты, указанные в настоящем Уведомлении о соблюдении конфиденциальности. Пользуясь нашим сайтом, Вы осознаете, что хранение и обработка Ваших Персональных данных могут осуществляться в США и в других странах, в которые мы можем передавать Вашу информацию при проведении нашей бизнес-деятельности.

Сообщение для жителей Калифорнии

В связи с определенными ограничениями, изложенными в Гражданском кодексе Калифорнии, § 1798.83, жители Калифорнии могут обратиться за предоставлением им (i) списка определенных категорий Персональных данных, которые мы раскрываем третьим сторонам в целях непосредственной маркетинговой деятельности за предыдущий календарный год, и (ii) идентификационных данных таких третьих сторон. Чтобы подать этот запрос, жителям Калифорнии следует обращаться к нам по адресу privacy@radiometer.dk.

Изменения в нашей Политике конфиденциальности

Мы используем Персональные данные исключительно в соответствии с положениями, изложенными в настоящей Политике конфиденциальности, если информация была получена от Вас, или на основании Вашего разрешения. Однако, в соответствии с какими-либо применимыми требованиями относительно согласия, мы оставляем за собой право время от времени вносить изменения в положения настоящей Политики конфиденциальности. Все изменения в этой Политике конфиденциальности будут опубликованы на этой странице, с указанием новой даты вступления в силу. Компания Радиометер настоятельно рекомендует Вам регулярно просматривать эту Политику конфиденциальности на предмет любых изменений. Все Персональные данные, полученные в ходе постоянного использования Вами Сайтов компании Радиометер, будут обработаны в соответствии с правилами опубликованной в настоящее время Политики конфиденциальности.

Конфиденциальность и безопасность

Компания Радиометер (далее — «Компания Радиометер»), совместно с ее аффилированными лицами и дочерними компаниями, уважает Ваше право на неприкосновенность частной жизни, ценит наше сотрудничество и обязуется обеспечивать конфиденциальность Ваших данных. Мы осознаем, насколько вопросы конфиденциальности важны для наших клиентов и посетителей веб-сайтов компании Радиометер. Использование нами Персональных данных регулируется нашей Политикой конфиденциальности, и посещая и пользуясь веб-сайтами компании Радиометер, Вы обязуетесь соблюдать положения этой Политики конфиденциальности.
Вы осознаете и соглашаетесь с тем, что при передаче через веб-сайты компании Радиометер информации, позволяющей установить Вашу личность, несмотря на предпринятые Операционной компанией меры по защите несанкционированного доступа или вмешательства, гарантировать абсолютную безопасность невозможно. В МАЛОВЕРОЯТНЫХ СЛУЧАЯХ ВМЕШАТЕЛЬСТВА ИЛИ НЕСАНКЦИОНИРОВАННОГО ДОСТУПА, НЕСМОТРЯ НА ВСЕ НАШИ УСИЛИЯ, КОМПАНИЯ РАДИОМЕТЕР НЕ БУДЕТ НЕСТИ ОТВЕТСТВЕННОСТЬ ЗА ТАКИЕ ВМЕШАТЕЛЬСТВА ИЛИ НЕСАНКЦИОНИРОВАННЫЙ ДОСТУП, ИЛИ ПРЯМЫЕ, КОСВЕННЫЕ, ОСОБЫЕ, СЛУЧАЙНЫЕ ИЛИ ОПОСРЕДОВАННЫЕ УБЫТКИ (ВКЛЮЧАЯ ПОТЕРЮ ПРИБЫЛИ), ПОНЕСЕННЫЕ КЛИЕНТОМ ИЛИ ПОЛЬЗОВАТЕЛЕМ, ДАЖЕ ЕСЛИ ОПЕРАЦИОННУЮ КОМПАНИЮ ЗАБЛАГОВРЕМЕННО ПОСТАВИЛИ В ИЗВЕСТНОСТЬ О ВОЗМОЖНОСТИ ТАКИХ УБЫТКОВ, КОМПАНИЯ РАДИОМЕТЕР НЕ ДАЕТ НИКАКИХ ГАРАНТИЙ, ЯВНЫХ ИЛИ ПОДРАЗУМЕВАЕМЫХ, ЧТО ИНФОРМАЦИЯ, ПРЕДОСТАВЛЕННАЯ ЛЮБЫМ КЛИЕНТОМ, БУДЕТ АБСОЛЮТНО ЗАЩИЩЕНА ОТ ВМЕШАТЕЛЬСТВА ИЛИ НЕСАНКЦИОНИРОВАННОГО ДОСТУПА, И НЕ ДАЕТ НИКАКИХ КОСВЕННЫХ ГАРАНТИЙ В ПЛАНЕ КОММЕРЧЕСКОЙ ПРИГОДНОСТИ ИЛИ ПРИЕМЛЕМОСТИ ДЛЯ ОПРЕДЕЛЕННЫХ ЦЕЛЕЙ. КАЖДЫЙ КЛИЕНТ НЕСЕТ ОТВЕТСТВЕННОСТЬ ЗА СОДЕРЖАНИЕ В ТАЙНЕ СВОЕГО ПАРОЛЯ.

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Table of Contents for RADIOMETER FLEX ABL90:

Calibration results • A calibration result is a combination of numerous smaller calibration activities • Calibration results from the most recent activity are marked in bold • Calibration results originating from a previous activity are marked in light gray color • If a calibration result is generated in connection with a measurement, there is a link to the related result • If a 2-point calibration is initiated, all results are recent activities and therefore marked in bold Automated corrective a
29 General measuring principles Introduction There are four different measuring principles employed in the sensors in the ABL90 FLEX analyzer. • Potentiometry: The potential of a sensor chain is recorded using a voltmeter, and related to the concentration of the sample (the Nernst equation). The potentiometric measuring principle is applied in the pH, pCO 2 , K + , Na + , Ca 2+ and Cl – sensors. • Amperometry: The magnitude of an electrical current flowing through a sensor chain is proportional to the concentration of the substance being ox
27 Quality control and calibrations, continued Start of the system-check cycle System checks: Automatic test sequences done with each measurement and at other times to make sure that all parts of the analyzer operate within speciﬁcations. Built-in QC measurements Sensitivity calibration of p CO 2 , c Glu, c Lac and status calibration of the oximetry parameters Sensitivity calibration of pH and the electrolytes ( c K + , c Na + , c Ca 2+ , c Cl – ) Sensitivity calibration of p O 2 Time pe
11 Capillary tube samples – preanalytical errors, continued Sample collection and handling 5. Sample should be free of air bubbles • Air bubbles can affect O 2 and CO 2 values • Ensure the end caps match the type of capillary tube • Cap both ends of the sample to avoid contact with room air 6. Mixing • Mix GENTLY with the mixing wire and magnet to avoid hemolysis of the sample • Hemolysis may cause K + ↑, Na + ↓ and Ca 2+ ↓ • Mix 20 times along the full length of the capillary tube or mix
Notes 35 of 36EXT-VEND-MAN-0023-1 Owner:Julie Monnox Approved:27 Mar 2019
Key operator training 21 Key operator training To aid key operators who manage devices and provide operator training, in-depth knowledge of device concepts and specifications will be provided in the following. The training material is partially based on the operator’s manual and is designed to convey information in tables and diagrams for fast interpretation. We offer a variety of tools to aid the key operator: • Operator training guides to ensure consistent messaging across training sessions • Training
2 Operator training Even a simple process or task can become erroneous and complicated without proper and relevant training. To ensure satisfaction and efficient use of this Radiometer product we offer a range of training materials. ABL90 FLEX analyzer Operator Training Guide The operator training guide is a supporting tool for the person training the operators of the device. The guide includes information on how to handle various processes and tasks related to the device. The information is given in short b
14 5. Appropriate patient information If applicable, explain how to recognize a mandatory field by the pointing hand. A mandatory field needs an entry before the results can be shown. Results will be recorded but will not be visible or retrievable without advanced user access. • Other patient information for calculations or clinical value. Follow local guidelines. 6. View results (on-screen, printout or local information system) Discuss actions according
6 Syringe samples – preanalytical errors, continued Sample collection and handling 5. Visually inspect sampler and expel all air bubbles • Air bubbles can affect O 2 and CO 2 values safePICO syringes: Expel air bubbles through the vented safeTIPCAP • Cap syringe to avoid contact with room air 6. Manual mixing or mixing using the integrated mixing device Stress that mixing makes the sample more homogeneous: • Mixin
5 Syringe samples – preanalytical errors Sample collection and handling 1. Stable respiratory condition To get a true picture of the patient’s respiratory condition the patient should ideally be in a steady state of ventilation: • Patients should be at rest for 5 minutes before sampling • Ventilatory settings should be unchanged for 20 minutes before sampling • Pain and anxiety can influence the state of respiration so this should be minimized wherever possible 2. Appropriate patient and sample identiﬁcation • Prev
32 Limitations of the measuring system Limitations of the measuring system Please use the latest version of the «ABL90 FLEX Instructions for use» («Specification» chapter). 32 of 36EXT-VEND-MAN-0023-1 Owner:Julie Monnox Approved:27 Mar 2019
Changing consumables – solution pack • Show how to enter Analyzer Status on the analyzer screen and find > Consumables > Replace > Replace Solutions. • Lift the inlet handle to the capillary position and wait until the solution pack is released • Let the trainee remove the solution pack and dispose of it as biohazardous waste according to local guidelines • Take a new solution pack and demonstrate how get it out of the box without pulling or lifting in the pump tube • Lift the new solution pack out of its box as shown
Parameters 31 Measured parameters Ranges of indication and reportable ranges can be found in the ABL90 FLEX Instructions for use. Be sure to always consult the latest version. The Range of indication for a parameter is the range within which the analyser is physically capable of measuring. Reportable range is the range of results from a testing system or method over which the analytical performance is claimed. The default reportable ranges stated in the ranges over which Radiometer has va
Changing consumables, continued Changing the thermal printer paper • Show how to enter Analyzer Status on the analyzer screen and find > Consumables > Replace > Paper • Show where to find and press the release button to open the cover and remove the used paper roll • Let the trainee place the new paper roll, tell or show that the paper must unwind from below • Let some paper extend out of the printer • Close the cover and tell that the cover must “click” to be correctly in place • Point to the analyzer screen and comple
7 Syringe samples – how to measure a patient sample 1. Operator identiﬁcation • Sharing barcodes • Accountability and traceability • Patient records are kept according to local rules (usually records are kept for many years) 2. «Ready» mode Point to the analyzer status field and explain how the analyzer will display current activity. The analyzer can only measure samples when the sc

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Анализатор ABL90 FLEX предназначен для определения газов крови, электролитов, глюкозы, лактата и параметров оксиметрии.

Он обладает всеми преимуществами компактной системы, основными из которых являются простота и надежность.

Быстрая замена расходных материалов и минимальное время анализа делает его идеальным прибором для использования в различных клинических целях, а также как резервный анализатор в центральной лаборатории.

Применение передовых технологий ко-оксиметриии и автоматического контроля качества от компании Radiometer позволяет гарантированно получить точный результат, который удовлетворит Ваши диагностические потребности.

По желанию укомплектовывается аккумуляторной батареей.

Технические характеристики

Портативный картриджный анализатор
Измеряет 17 параметров, вычисляет 47
Объем пробы всего 65мкл
Время измерения 35 с, от результата до результата 60 с
Автоматический контроль качества
Возможность измерения при питании от батареи
Полностью русифицирован
Полная совместимость с лабораторными и госпитальными информационными системами

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(Ocr-Read Summary of Contents of some pages of the RADIOMETER FLEX ABL90 Document (Main Content), UPD: 16 June 2023)

23, 23 Replacements, continued Consumables Default tests or Recommended replacement activities per day interval after installation Solution pack 10 Maximum 30 days or when the number of activities is zero Sensor cassette 10 Maximum 30 days or when the number of tests is zero Inlet gasket holder 10 12 months Inlet connector gasket 10 12 months Can a sensor cassette be used again? A s…
10, 10 Capillary tube samples – preanalytical errors Sample collection and handling 1. Stable respiratory condition To get a true picture of the patient’s respiratory condition, the patient should ideally be in a steady state of ventilation: • Patients should be at rest for 5 minutes before sampling • Ventilatory settings should be unchanged for 20 minutes before sampling • Pain and anxiety can influence the state of respiration so this should be mi…
11, 11 Capillary tube samples – preanalytical errors, continued Sample collection and handling 5. Sample should be free of air bubbles • Air bubbles can affect O 2 and CO 2 values • Ensure the end caps match the type of capillary tube • Cap both ends of the sample to avoid contact with room air 6. Mixing • Mix GENTLY with the mixing wire and magnet to avoid hemolysis of the sample • Hemolysis may cause K + ↑, Na…
31, RADIOMETER FLEX ABL90 Parameters 31 Measured parameters Ranges of indication and reportable ranges can be found in the ABL90 FLEX Instructions for use. Be sure to always consult the latest version. The Range of indication for a parameter is the range within which the analyser is physically capable of measuring. Reportable range is the range of results from a testing system or method over which the analytical performance is claimed. The default reportable ranges stated i…
13, RADIOMETER FLEX ABL90 13 4. Introducing the sample Present the following steps on how to introduce the sample. Then the trainee should repeat the steps as a practical exercise. Inform the trainee that the analyzer will guide with on-screen video, sound and instructions during the process. Key words: LIFT – PUSH – HOLD – REMOVE – CLOSE LIFT • Lift the inlet to the “Capillary” position until the green light appears. PUSH • Push the capillary t…
21, Key operator training 21 Key operator training To aid key operators who manage devices and provide operator training, in-depth knowledge of device concepts and specifications will be provided in the following. The training material is partially based on the operator’s manual and is designed to convey information in tables and diagrams for fast interpretation. We offer a variety of tools to aid the key operator: • Operator training guides…
6, 6 Syringe samples – preanalytical errors, continued Sample collection and handling 5. Visually inspect sampler and expel all air bubbles • Air bubbles can affect O 2 and CO 2 values safePICO syringes: Expel air bubbles through the vented safeTIPCAP • Cap syringe to avoid contact with room air 6. Manual mixing or mixing using the integrated mixing device Stress that mixing makes the sample more homogeneous: • Mixing reduces sedimentation • Hemolysis may ca…
19, 19 Troubleshooting Explain how the trainee can see when the analyzer is ready for use: The analyzer is ready for use when all three conditions are present. 1. The analyzer is in Ready mode. 2. The color of the tab of the parameters you want to get a result for is green or yellow. 3. The color of the traffic light in the Analyzer status button is green or yellow. If applicable, explain about the following points: Remaining test cycles: • Sensor cassett…
20, General information Training method Take the trainee through the following general information, demonstrating the processes when it seems necessary. Cleaning the analyzer • Remember to clean the inlet and the integrated mixing device according to local guidelines Compliance Infection control • Always comply with hospital guidelines regarding collection, handling, and disposal of blood • Password expiration – if applicable, discuss why it is necessary …
26, RADIOMETER FLEX ABL90 Overview of quality control management Quality control management is important as it evaluates the performance of the analyzer to make sure that the patient results are accurate and precise. The analyzer manages quality control automatically, but if local, federal or state regulations require additional quality control procedures, operators can do them. Automatic quality control management (AQM) is the name given to qualit…
30, 30 Overview General construction Sensors The term sensor refers to an 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: Bottom sensor board: Theoretical aspects of the blood gas analyzer 30 of 36EXT-VEND-MAN-0023-1 Owner:Julie Monnox Approved:27 Mar 2019 …
4, 4 What is what Touch screen Solution pack with waste pouch, reagents and QC. The QC is built-in and automatic for accuracy and full regulatory compliance. Sensor cassette compartment behind the door Self-cleaning inlet aspirates the sample in 5 seconds Automatic sample mixing for safePICO syringes (mixing takes 7 seconds) Integrated barcode reader Fully operational on battery and optional rolling stand for added flexibility Identify the main parts of the an…
9, 9 4. Appropriate patient information If applicable, explain how to recognize a mandatory field by the pointing hand. A mandatory field needs an entry before the results can be shown. Results will be recorded but will not be visible or retrievable without advanced user access. • Other patient information for calculations or of clinical value. Follow local guidelines. 5. View results (on-screen, printout or local …
14, RADIOMETER FLEX ABL90 14 5. Appropriate patient information If applicable, explain how to recognize a mandatory field by the pointing hand. A mandatory field needs an entry before the results can be shown. Results will be recorded but will not be visible or retrievable without advanced user access. • Other patient information for calculations or clinical value. Follow local guidelines. 6. View results (on-screen, printout or local information system) Discuss actions accordin…
33, 33 Analyzer setup Managing operators • Analyzers set up for anonymous use: Operators do not have to log on • The access profile selected for anonymous use specifies the short cut buttons and menus available for anonymous operators For further instructions on how to manage operators, please refer to the latest version of “ABL90 FLEX Instructions for use” (under “Setup”). Setup and Data backup For further instru…
1, Operator Training Guide ABL90 FLEX analyzer 1 of 36EXT-VEND-MAN-0023-1 Owner:Julie Monnox Approved:27 Mar 2019
…
15, 15 Component consumables 1 Reference range 4 Reportable range 2 Lower critical limit 5 Range of indication 3 Upper critical limit Smart chip containing various information, no further scanning of product barcodes necessary Contains pouches with QC and calibration material, a gas mixture and closed containers to hold liquid waste Security pin for activation of the solution pack Training method To enhance the trainee’s understanding of how to change…

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Related Manuals for RADIOMETER ABL90 FLEX

Summary of Contents for RADIOMETER ABL90 FLEX

Page 9: Table Of Contents

Page 21: Setup

Page 23: Setup Menu Structure

Page 24: Analyzer Security

Page 25: Operators And Passwords

Page 28: Access Profiles

Page 30: Analysis Setup

Page 31: Setting Up A New Measuring Mode

Page 32: Selecting A Default Layout

Page 33: Setting Age Group Limits

Page 34: Setting Reference And Critical Limits For Each Parameter

Page 35: Reportable Ranges

Page 36: Patient Report Setup

Page 37: Editing A Layout

Page 38: Default Values

Page 39: Editing Patient Result Layout

Page 40: Sample Pre-Registration Setup

Page 41: Sample Age Evaluation Setup

Page 42: Calibration Schedule Setup

Page 43: Quality Control Setup

Page 44: Quality Control Schedule Setup

Page 46: Qc Ranges

Page 48: Qc Input Setup

Page 49: Qc Statistics

Page 50: Westgard Rules Setup

Page 52: Reference

Page 55: Replacement Setup

Page 56: Recommended Replacement Intervals

Page 57: User Activities

Page 58: Editing A User Activity

Page 59: Maintenance Planning

Page 60: Replacement Warnings

Page 61: Parameters And Input Setup

Page 63: Units Setup

Page 64: User-Defined Patient Data Items

Page 66: User-Defined Notes

Page 67: Analyzer Settings

Page 68: Time/Date Setup

Page 69: Acoustic Signal Setup

Page 70: Barometer Setup

Page 71: Languages

Page 72: Communications Setup

Page 73: Lis/His Connection Setup

Page 75: Automatic Data Transmission Setup

Page 77: Automatic Data Request Setup

Page 78: Patient Lookup Setup

Page 79: Qa Portal Connection Setup

Page 80: Disk Functions Setup

Page 82: Automatic Backup Setup

Page 83: Printers

Page 84: Automatic Printing

Page 85: Corrective Actions

Page 86: Explanation Of Corrective Actions

Page 87: Miscellaneous Setup

Page 88: Selecting Hbf Correction

Page 89: Analyzer Messages

Page 90: Setup Default Settings

Page 92: Calibration Schedule

Page 93: Replacement Setup

Page 98: Print Setup

Page 99: Contents Of Setup Settings

Page 100: General Group

Page 101: Schedules, Etc

Page 102: Interfacing Facilities

Page 103: External Barcode Reader

Page 104: Sample Counter

Page 106: Disk Functions Setup Programs

Page 107: Creating A Wdc Report

Page 108: Backing Up All Data

Page 110: Restoring All Data

Page 111: Exporting Data Logs

Page 112: Importing/Exporting Archives

Page 113: Saving Setup

Page 114: Loading/Restoring Setup

Page 116: Wet Section

Page 117: Wet Section Diagram

Page 118: Measuring Processes