Instructions for Use
162 Pages
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AQT90 FLEX Instructions for use from software version 8.4
AQT90 FLEX instructions for use
Contents 1. Introduction Intended use
1 ... 1
Limitations of use
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Operator requirements Documentation Hazards
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General warnings, cautions and notes
... 2
2. Getting to know the analyzer Overview of the analyzer Front view
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Use of the barcode reader Back view
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Consumables
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To see details about installed consumables Data about installed consumables
... 5
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5
Is the analyzer ready for use?
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Three important conditions
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Parameter tab colors
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The Analyzer status screen
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Analyzer status - Traffic light colors Messages Issues
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To find and troubleshoot issues Ready modes
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Non-Ready modes
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User interface
... 9
Result links
... 9
Status in result links
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Back and Close buttons Check buttons Basic tasks
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To scan a barcode To enter text To log on
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To save changes
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AQT90 FLEX instructions for use
Menu
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Menu structure Data logs
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Overview of data logs Patient profiles log
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Patient profiles log
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To access data logs
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To edit a patient profile
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To add a new patient profile
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To remove a patient profile
... 12
To find a patient profile Activity logs
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To see activities in the Activity log
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To add a message to the Activity log
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To filter activities from the Activity log
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3. Patient sample analysis
15
General warnings and cautions
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To get good results
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Maximum sample age
...
Sample tubes
Sample types
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Barcode labels on sample tubes
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Analyzing patient samples
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To analyze a sample
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To request patient data manually To change the report layout
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To add a test to an analysis in progress To stop a patient sample analysis To remove a sample tube Patient results
17
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To edit patient identification data
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To use a Registration Ticket To find a patient result
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To edit Patient identification data Symbols on patient results
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To see messages on patient results
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Reviewing and editing patient results
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To approve a patient result
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To reject a patient result
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To remove a test result from a patient result To see the audit trail on a patient result
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AQT90 FLEX instructions for use
To filter data from the Patient results log To see trends in a patient's results
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4. Maintenance
23
To order consumables Cartridges
... 23
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To see the status of installed cartridges To insert a cartridge
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To select and replace a cartridge Solution Pack
23
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To replace the Solution Pack Thermal printer paper
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To replace the thermal printer paper Protection of printed data System clean
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System clean
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System clean frequency
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To do a system clean
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To find a system-clean record
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To add a note to a system-clean record Cleaning
... 27
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Blood spillage inside the analyzer To clean the touch screen
... 27
To clean the analyzer exterior Disinfecting
... 27
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To disinfect the touch screen
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To disinfect the analyzer exterior Recording an operator activity To record an operator activity
27
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Analyzer service
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For service
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To find the installation number of the analyzer To find the version of software installed
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To see an overview of measurements and tests done on the analyzer Sample counter
... 29
Needle replacement
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To find the number of times the needle has been used To record a service inspection
Quality control (QC)
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Battery on the printed circuit (PC) board
5. Quality control
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AQT90 FLEX instructions for use
Quality control (QC) management
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Frequency of liquid quality control (LQC) measurements LQC solutions
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LQC measurements
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To analyze a Radiometer LQC solution
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To analyze a non-Radiometer LQC solution To stop an LQC measurement LQC results
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To find an LQC result
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Symbols on LQC results
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To see messages on an LQC result Reviewing LQC results
... 34
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To filter data from the LQC log
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To see trends in LQC results
... 34
LQC statistics
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To find and print LQC statistics LQC plots
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To find an LQC plot
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Symbols on LQC plots
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LQC after calibration adjustments
... 36
LQC after calibration adjustments
... 36
Frequency of LQC after calibration adjustments
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To verify the calibration adjustment of a test lot
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To find results of an LQC done after a calibration adjustment
... 38
Symbols on results of an LQC done after a calibration adjustment System checks System checks
... 38
... 38 ... 38
To do a manual system check
... 39
To find system-check results
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To see messages on a system-check result Calibration verification (in the USA) Calibration verification
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Frequency of calibration verification To do an LCR measurement
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To find an LCR measurement result
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Symbols on LCR measurement results
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6. Calibration adjustment Calibration adjustment
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Frequency of calibration adjustment
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Pending and active calibration adjustments Status of calibration adjustments
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AQT90 FLEX instructions for use
To find the status of calibration adjustments
... 43
To see and print active calibration adjustments
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Doing calibration adjustments
To do a calibration adjustment
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To invalidate an active calibration adjustment
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To do the calibration adjustment of a test lot again To do an "in queue" calibration adjustment To do a pending calibration adjustment
Calibration adjustment results
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To do a number of calibration adjustments To stop a calibration adjustment
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To find results of a calibration adjustment
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To see messages on a calibration adjustment result Reviewing calibration adjustment results
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To filter data from the Cal.adjustment log
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To see trends in the calibration adjustment log
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7. Troubleshooting
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To get back to a "Ready" mode Message types
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To troubleshoot messages that require some action
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50
Messages that require some action
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Messages that do not require action
... 66
8. Shutting down, moving and restarting the analyzer Shutting down the analyzer
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When to shut down the analyzer To do a temporary shutdown
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Long-term shutdown of the analyzer Moving the analyzer
71
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To move the analyzer on a trolley Restarting the analyzer
... 71
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To restart the analyzer after a temporary shutdown
... 72
To restart the analyzer after a long-term shutdown
... 72
9. Installation Installing the analyzer
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Delivery of the analyzer
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Preparing the location for the analyzer To unpack and move the analyzer To install the analyzer
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AQT90 FLEX instructions for use
Installing peripheral devices
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To install a USB external keyboard / mouse
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To install a PS/2 external keyboard / mouse
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To do a temporary shutdown
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To restart the analyzer after a temporary shutdown
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To install an external barcode reader
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To connect the analyzer to a network
... 77
10. Setup
79
Setup menu structure To print setups
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Managing operators
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To select the logon procedure Access profiles
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To edit an access profile
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To prevent patient sample analysis Anonymous use
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To set up anonymous use
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Default operators
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To add an operator
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To remove an operator
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To set a logoff time for all operators Centralized user management
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To set up centralized user management Event logging
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Logged events Event log
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To enable event logging
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To examine the competency of an operator Compliance training
... 85
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Compliance training
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To get the 'Demo' parameter
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To set up and do compliance training
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Blank Cartridges
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Demo parameter
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To set up the analyzer for compliance training Setups created for the "Demo" parameter To train operators to analyze samples Analyzer operations
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To lock the analyzer
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To unlock the analyzer
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To lock/unlock parameters for measurement
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AQT90 FLEX instructions for use
To show a message on the analyzer screen To calibrate the touch screen Analyzer settings
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To enable the screen saver
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To create a heading for printed data
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To set the time and date
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To set the acoustic signals
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To mute all acoustic signals
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To change the language on the screens
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Analysis setup
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Test panels
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Test panels
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To set up test panels Tube types
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Tube types
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To set up a tube type Citrate correction Test order codes
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Test order codes
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To set up test order codes
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Reference ranges and critical limits Reference ranges Critical limits
... 91
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To set up reference ranges and critical limits Reportable ranges
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Reportable ranges
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To set up reportable ranges Registration Tickets
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Registration Tickets
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To select data in Registration Tickets
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To set up automatic printing of Registration Tickets Result links
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To set up result links Sample registration
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Sample age calculation
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Maximum sample age
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To set a maximum sample age
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To interpret barcodes on sample tubes Patient ID / Report layouts Patient ID / Report layouts
... 94
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To create a Patient ID / Report layout
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To select a Patient ID / Report layout as default
... 95
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AQT90 FLEX instructions for use
To edit a Patient ID / Report layout
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To create extra items for use in Patient ID / Report layouts Report layout for LCR measurements Patient result settings
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To create a layout for patient results To enable patient result approval Parameter settings
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To show the parameter bar
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To show/hide parameter tabs in the parameter bar To hide the parameter bar
... 98
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To set up measurement units for parameters Calibration adjustment settings
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User-defined corrections (offset and slope)
... 99
To edit the offset and slope for a parameter
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To limit when calibration adjustments can be stopped Quality control
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100
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Liquid quality control (LQC) solutions Registration of LQC solutions
... 100
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Data saved during registration of LQC solutions To register a Radiometer LQC solution
... 101
To register a non-Radiometer LQC solution Edit data about registered LQC solutions
... 101
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To edit data about a registered LQC solution
... 102
To change the user-defined control range of a parameter To change user-defined control ranges to lot-to-date ranges To edit the standard deviation for parameters To select the parameters to be measured Scheduled LQC measurements
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To schedule LQC measurements
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To edit an LQC measurement schedule
... 105
To set up corrective actions for overdue scheduled LQC measurements ... 105 Corrective actions on LQC results
... 106
To set up corrective action for errors in LQC results To apply user-defined corrections to LQC results LQC statistics
... 106 ...
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To set the statistical factor and a reminder to print To enable Levey-Jennings plots to be viewed Westgard Rules Westgard Rules
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Types of Westgard Rule
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Description of the lines used in Westgard rule illustrations Westgard rules and corrective actions
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AQT90 FLEX instructions for use
To set up Westgard rules
... 109
To apply Westgard Rules to LQC results RiLiBÄK rules
... 109
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RiLiBÄK rules
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To access the RiLiBÄK ranges setup screen To apply RiLiBÄK rules that are “On” To add a new RiLiBÄK rule To edit a RiLiBÄK rule
... 109
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To remove a RiLiBÄK rule
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To set the On/Off value of a RiLiBÄK rule to "Off" System check
... 111
System check
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To schedule automatic system checks Maintenance setup
... 111
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Mandatory maintenance activities Maintenance activities
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To edit the warning/critical limits for mandatory maintenance activities ... 112 To schedule mandatory maintenance activities by time
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To set up corrective action for overdue mandatory maintenance activities ... 113 To set up corrective action for overdue scheduled system cleans Operator-defined activities Operator activities
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To set up an operator activity
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To set up corrective action for pending operator activities To delete an operator activity Replacement warnings
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To set up replacement warnings Note fields
... 113
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To create standard texts for use in Note fields Communications
... 115
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Patient data saved on the analyzer
... 115
Patient data from LIS/HIS/data management systems
... 115
To set up a LIS/HIS connection
... 116
To set up a RADIANCE connection
... 116
To set up automatic requests for patient data
... 116
To set up automatic transmission of patient results to a system To enable patient data to be requested manually FLEXLINK modules*
... 117
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To enable the use of FLEXLINK modules*
... 118
To access the RADIANCE system from the analyzer
... 118
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AQT90 FLEX instructions for use
Printers
... 118
To set up automatic printing
... 118
To enable test results to be printed immediately To install a new printer for the analyzer To remove a printer from the setup To edit the name of a printer Data logs and archives
... 119
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To set up automatic archiving
... 119 ... 120
File format of exported data logs
... 120
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To export a whole archive
... 120
To export parts of an archive To import an archive
... 121
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Data backup and restoration Backup
... 119
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Data logs and archived data logs
To export data logs
... 118
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Destinations for backup data
... 122
To schedule automatic backups
... 122
To do a manual backup
... 122
To restore data from a backup Saving and loading setups
... 122
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To save the setup
... 123
To load a setup
... 123
To restore Radiometer default settings
... 123
11. Principles of operation Immunoassays
125
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The dry-chemistry concept for immunoassays
... 125
The sample analysis process for immunoassays
... 125
Coagulation assays
... 126
The dry-chemistry concept for coagulation assays
... 126
The sample analysis process for coagulation assays
... 126
Built-in hematocrit (Hct) determination
... 127
Built-in hematocrit determination
... 127
Method of detection (TRF)
... 127
Time-resolved fluorometry
... 127
12. Specifications Product specifications
131 ... 131
Environmental specifications
... 133
Detachable power supply cord
... 134
Tubes approved for use with the analyzer
x
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AQT90 FLEX instructions for use
13. Graphical symbols
137
Explanation of graphical symbols
... 137
14. Legal information
139
Patents and trademarks
... 139
Patents
... 139
Trademarks Legal notices
... 139 ... 139
System performance
... 139
Third party software and trademarks Warranties and disclaimer Confidentiality Changes
... 140
... 140
... 140
End-user licence agreement with MS
Index
... 139
... 140
143
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AQT90 FLEX instructions for use
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1
Introduction Intended use For in vitro diagnostic use.
The AQT90 FLEX analyzer is an immunoassay instrument based on the quantitative determination of time-resolved fluorescence to estimate the concentrations of clinically relevant markers on whole-blood and plasma specimens to which a relevant anticoagulant has been added. It is intended for use in point-of-care and laboratory settings. Note: The AQT90 FLEX parameter-specific Test Kit inserts tell you whether both types of sample can be used and list the anticoagulants that can be used for each assay/test.
Limitations of use Operators must read the performance data of the analyzer to make sure that it satisfies their analytical needs. A clinician must always interpret patient test results in the relevant clinical context. WARNING – Risk of incorrect results on subsequent samples Only analyze human blood and plasma samples or dedicated quality control material. CAUTION – Risk of equipment damage Only analyze human blood and plasma samples or dedicated quality control material.
Operator requirements Operators must be trained to use this analyzer.
Documentation CAUTION – Risk of equipment damage The documents in the table give instructions for the safe and proper operation of the analyzer. Radiometer does not accept warranty claims or product liability if operators do not obey the instructions.
Document
Description
Instructions for use
How to install and set up the analyzer, instructions for daily use and reference information
Inserts
Instructions and information about consumables supplied for use with the analyzer
1
Introduction
AQT90 FLEX instructions for use
Document
Description
Short-form instructions
A summary of key instructions showing how to do daily procedures
Ordering information
Name and reference ordering number (REF) of products used with the analyzer
Hazards A hazard symbol shows which instructions an operator must obey to prevent risk to persons or equipment. There are two types of hazard.
Hazard type
Hazard symbol
Risk
WARNING
Death or injury to persons
CAUTION
Equipment damage
General warnings, cautions and notes WARNING – Risk of electric shock Make sure the analyzer is a minimum of 1.5 m from patient beds. WARNING – Risk of infection Dispose of all used sample tubes, quality control (QC) tubes and Solution Packs as biohazardous waste. Follow your local regulations. CAUTION – Risk of equipment damage Instructions for use documents are provided with the analyzer. Use them to find out how to operate the analyzer. Radiometer will not accept warranty claims or product liability claims if procedures are not followed. Note: Do not put paper or other objects underneath the analyzer as it will decrease the volume of air that can be drawn through the analyzer to cool it.
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Getting to know the analyzer
2
Overview of the analyzer Front view
1
Thermal printer
5
Compartment for cartridges
2
Sample inlet
6
Solution Pack compartment
3
Touch screen
7
Solution Pack
4
Barcode reader
8
USB port
Use of the barcode reader The barcode reader is used to read data in barcodes supplied with consumables and barcodes that identify personnel, patients and patient samples.
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Getting to know the analyzer
AQT90 FLEX instructions for use
Back view
1
Speaker
7
USB ports
2
Memory card
8
Network cable port
3
Reset buttons
9
Mains power socket
4
External keyboard and mouse ports
10
Mains power fuse
5
External monitor port
11
Power switch ON (-) and OFF (O)
6
Barcode reader port
Consumables Consumables are products that are used up during operation of the analyzer. See the AQT90 FLEX ordering information document for details.
Consumbles
Description
Cartridges
Cartridges for calibration adjustment, tests and maintenance activities
Solution Pack
Contains buffer material and closed containers that hold used test cups and liquid waste
Thermal printer paper
Paper for the thermal printer
LQC solutions
Liquid quality control solutions
Cleaning Solution Tubes Contain cleaning solution for system clean and maintenance activities Empty Tube Kit
Used for non-Radiometer LQC solutions
Sample tubes
Used to hold samples for analysis. The tubes contain anticoagulants.
Related topics • Tubes approved for use with the analyzer, page 134
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AQT90 FLEX instructions for use
Getting to know the analyzer
To see details about installed consumables 1.
Tap Menu > Analyzer status > Consumables. Some data is shown.
2.
Tap the Detailed inventory button to see more data about the installed cartridges.
Data about installed consumables The Consumables part of the Analyzer status screen shows data about the installed Solution Pack and some data about the installed cartridges. More data about each installed cartridge is shown in the Detailed inventory screen.
Consumable Screen
Details
Solution Pack Consumables
• • • •
Cartridges
Consumables
• Total number of remaining tests for each parameter • Total number of used/expired cartridges for each parameter
Cartridges
Detailed inventory
• • • • •
Lot number Installation date On-board expiry date Remaining cup capacity. This is the estimated number of used test cups the Solution Pack still has space for.
Number of remaining tests Lot number On-board expiry date Cartridge type Status - valid or invalid. Cartridges are valid until their expiry date or on-board expiry date. • Calibration adjusted? - yes or no
Is the analyzer ready for use? Three important conditions The analyzer is ready for use when three conditions are present.
1.
The analyzer is in one of three Ready modes: Ready, Ready for sample registration, or Ready for sample registration and cartridge replacement.
2.
The color of the tab of the parameters you want to measure must be green or yellow.
3.
The color of the traffic light in the Analyzer status button is green or yellow.
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Getting to know the analyzer
AQT90 FLEX instructions for use
Parameter tab colors Parameter tab color
Indication
Green
The parameter can be measured
Yellow (with one line crossing)
An LQC error was found but the parameter can be measured
Red (with two lines crossing)
The parameter cannot be measured. The conditions that may cause a tab to be red are shown below. • No Test Cartridge is installed for the parameter • Installed Test Cartridges for the parameter have not been calibration adjusted, or no tests are available on them, or they are not valid • An operator has locked the parameter • A scheduled LQC measurement of the parameter is overdue • An LQC error was found. Corrective action has locked the parameter. • A scheduled system clean is overdue Note: A cartridge is not valid after its on-board expiry date or expiry date.
Related topics • To set up corrective action for errors in LQC results, page 106
The Analyzer status screen
The traffic light shown on the left side of the buttons in the Analyzer status screen shows the status of: • • • •
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Calibration adjustment Quality control Consumables Other activities (for example, maintenance activities)
AQT90 FLEX instructions for use
Getting to know the analyzer
• System messages A green traffic light shows that there are no issues. A yellow traffic light shows that there is a non-critical issue. A red traffic light shows that there is critical issue. The color of the traffic light on the Analyzer status button shows the most critical issue shown by these five traffic lights.
Analyzer status - Traffic light colors Traffic light color
Indication
Consequences
Green
No issues were found
All operations are possible
Yellow
A non-critical issue was found
Measurements and other activities are possible, but one or more issues need attention
Red
A critical issue was found
LQC measurements can be done if the analyzer operating mode is Locked - LQC pending. No other type of measurement and no calibration adjustments are possible.
Messages The analyzer uses messages to tell operators something. There are different types of messages.
Message type Where messages are shown Status
In Analyzer status screens
Feedback
In the space above the parameter bar. Note: Feedback messages tell operators something about an action that they have just done. Feedback messages are shown for a short period of time.
Pop-up
In pop-up windows. Note: Operators have to tap a button in pop-up windows to close them.
Result
In result message screens
Activity
In the Activity log screen
Issues Issues are messages that tell you about conditions that require some action.
To find and troubleshoot issues Prerequisite: The traffic light in the Analyzer status button is yellow or red. 1.
Tap Menu > Analyzer status.
2.
Tap the button on the right side of a yellow or red traffic light.
3.
Read and note the message numbers.
4.
Troubleshoot the messages.
5.
Do steps 2 to 4 again for each button with a yellow or red traffic light.
6.
Tap the Close button.
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