Radiometer Aqure User Manual
Contents
1. 49 Changes 50 Trademarks 50 Index 51 AQURE system instructions for use iv Introduction 1 About the AQURE system The AQURE system lets you manage analytical devices and their operators It manages issues related to the performance of these devices and helps you to resolve them quickly It gives a continuous overview of device status and helps you comply with regulatory requirements The system lets the user register samples and sends the results to the user and or the HIS LIS The system has these parts Dashboard shows key performance indicators KPIs device status and issues Issues is where you can explore assign resolve and record issues related to devices and operators Inspection ready contains reports that record your compliance with your regula tory requirements Patient view lets you filter patient lists and show sample results for each patient The AQURE FLEXLINK system links together and saves the patient operator and sampler ID data When measured the result is sent back to the patient bedside and or the HIS LIS system Device center gives a list view display of all the devices connected to the AQURE system Operators is where you add device operat2. 6 To resolve a calibration issue 7 About the quick close function 8 To handle multiple issues 8 About RiliB K rule violation issues 8 About the add issue screen 9 4 List views 11 About list views 11 To create your own list view 11 About Search 11 5 Inspection ready 13 About reports 13 Links between reports 13 Legend of QC statistical evaluation report 14 Reports 14 AQURE system instructions for use i 6 Patient view 17 About the patient view
3. 17 To find a patient s results 17 The result page 17 To see device performance when the patient sample was measured 18 7 AQURE FLEXLINK system 19 What is the AQURE FLEXLINK system 19 To register a sample 19 To edit sampler data 20 About the result page 20 The result page 20 To see patient results 21 8 The Device center 23 About the Device center 23 To see all devices in a department 23 About issues explore view 23 About the timelines 24 To find device data within a time ran
4. 37 To recalculate laboratory established ranges 38 11 My profile 39 To subscribe to issues 39 12 Reference information 41 Issues that the AQURE system creates 41 Issues created by the AQURE system 41 Device actions for Radiometer analyzers 42 Device actions for ABL90 FLEX analyzers 42 Device actions for AQT90 FLEX analyzers 43 Device actions for ABL800 FLEX and ABL700 series analyzers 44 Device actions for ABL80 FLEX series analyzers 45 AQURE system instructions for use iii Device actions for ABL5 analyzers 46 13 Legal notices 49 System performance 49 Third party software 49 Warranties and disclaimer 49 Confidentiality
5. 33 To show a hidden device 33 Configure parameter profiles 33 About the parameter profile 33 To create a parameter profile 34 To add parameters to a profile 34 To add input items to a profile 34 Course administration 35 About managing and assigning training courses 35 To add a course 35 To edit and publish a course 36 To publish a new version of a course 36 To retract and remove a course 37 RiliB K control range configuration 37 About RiliB K control ranges 37 To change to manufacturer ranges
6. 29 To search for operators course status 29 To assign a training course 29 Course status 30 AQURE system instructions for use ii 10 Administration 31 The AQURE hospital model 31 About the AQURE hospital model 31 About Administration 31 User administration 32 About user administration 32 To add a new user 32 To unlock a user 32 Device administration 32 To add a device to a department 32 About hidden devices 33 To hide a device
7. Enter the name of the parameter profile 5 Enter the sort order of the profile 6 Click the Save button To add parameters to a profile Prerequisite You must log on as an Administrator 1 Go to Administration 2 Click Configure parameter profiles 3 Click a profile in the list 4 Click the Add button 5 Select the parameter from the drop down list and click the Add parameter button 6 Repeat step 4 for more parameters 7 Click the Save button To add input items to a profile Prerequisite You must log on as an Administrator Note For more information on how to add input items to a profile contact you local Radiometer representative 1 Go to Administration 2 Click Configure parameter profiles 3 Click a profile in the list 4 Click the Add button below the Input items heading 5 Enter the name for the input item This is the name that is shown on the FLEXLINK sampler registration page 6 Enter the key The mandatory key must be the same in the AQURE system and the analyzer If there is a space in the key on the analyzer you must enter this as an underscore _ in the AQURE system The key must be unique within the profile Administration AQURE system instructions for use 34 7 Choose from these options Option Description Text Example operator name Number Example 21 for the FIO2 Floating point number Example 37 5 for the temperatu
8. 14 QC stat evaluation overview 14 QC statistical evaluation 13 14 QC statistics and linearity 14 QC status overview 14 QC status per department 14 QCs excluded from statistical evaluation 14 result page 17 RSS feeds widget 3 S Search 11 T time line patient results 24 timeline 24 training course search 29 troubleshooting 23 U user unlock 32 add 32 W warnings 2 widget add 3 change layout 3 issue list 3 latest QC status of all devices 3 move 3 Index AQURE system instructions for use 52 my issues 3 number of issues by type 3 number of POCT devices 3 patient sample heartbeat 3 QC heartbeat 3 remove 3 RSS feeds 3 standard 3 what is it 3 AQURE system instructions for use Index 53 Index AQURE system instructions for use 54 If you have any questions or need assistance please contact your local Radiometer representa tive Radiometer representative Code number 995 086 Version 201302E 2013 Radiometer Medical ApS All rights reserved Radiometer Medical ApS 2700 Br nsh j Denmark http www radiometer com
9. 6 resolved 9 root cause 9 save 9 severity 9 sort 11 status 9 summary 9 troubleshoot 23 what are they 5 calibration 7 QC range violation 6 record 9 rule violation 8 timeline 24 work with 6 workflow 5 issues report 14 L latest QC status of all devices widget 3 lock out date 27 M messages 25 my issues widget 3 N number of issues by type widget 3 number of POCT devices 3 O online help 1 operator home department 28 access 31 add 27 de activate 29 lock out 29 push 28 push to one device 28 role 31 to all devices 28 P parameter lock 25 parameter profile add parameters 34 create 34 input items 34 about 33 create 34 patient result access from Device Center 25 and device performance 18 details 25 find a result 17 symbols 17 troubleshoot 18 patient result icons 17 patient sample heartbeat widget 3 patient view 17 Q QC heartbeat widget 3 QC statistical evaluation overview report 14 QC statistical evaluation report 14 QC statistics and linearity report 14 QC status overview report 14 QC status per department report 14 QCs excluded from statistical evaluation report 14 R reports QC statistical evaluation 13 14 about 13 accessing quickly 13 14 calibration 14 control cycle evaluation 14 current parameter range setup 14 issues 14 QC range violations
10. About the Device center page 23 Device actions for ABL90 FLEX analyzers page 42 Device actions for AQT90 FLEX analyzers page 43 Device actions for ABL800 FLEX and ABL700 series analyzers page 44 Device actions for ABL80 FLEX series analyzers page 45 Device actions for ABL5 analyzers page 46 AQURE system instructions for use The Device center 25 Calendar You use the Calendar in the Device center when you want to see more about a device and in Operators when you want to set the lock out date of an operator The Calendar has 3 active areas where you can change the date Calendar Description 1 Title bar Changes the calendar range by month a year 10 years or 100 years 2 Left and right arrows Increase or decrease the calendar range by the selected unit of time For example a month a year 10 years or 100 years 3 Calendar Decreases the calendar range by year or month depending on what was selected in the title bar The Device center AQURE system instructions for use 26 Operator administration 9 About operator administration In operator administration you can set up operator profiles and push them to devices connected to the AQURE system For each device type you see the required number of QC and patient measurements the operator should do during a calendar month You see the number of currently completed measurements This feature works for all device types For Radiometer d
11. This report shows issues for QC range violations for a selected period of time QCs excluded from statistical calculation This report shows all QCs manually excluded from statistical calculations during a period of time QC statistics and linearity This report shows the linearity of a parameter for a selected period of time The area of a circle shows how big the standard deviation is There is an expectation that the area of a circle increases in proportion to the concentration of QC material for the parameter The CV shows if this increase is satisfactory There is a systematic bias on the result if the slope of regression equa tion is different from 1 00 0 1 Inspection ready AQURE system instructions for use 14 Report Description QC statistical evaluation This report shows the monthly evaluation of bias and imprecision The Levey Jennings plot shows the QC status for one parameter lot and level for a period of one month The table below the Levey Jennings plot shows the result of the statistical evaluations An SD value on a red background in the Month to date row shows that the monthly SD was greater than 150 of the lot to date SD A bias value on a red background in the Month to date row shows that the shift in bias from the previous period was greater than the lot to date SD QC statistical evaluation over view This report shows monthly evaluations for a selected period of time for a device a paramete
12. RSS feed This widget shows the RSS feed from the entered web page Graphical widgets The system includes these Graphical widgets 3 Widget Description Latest QC status of all devices A pie chart of the latest QC status of all devices Number of issues A pie chart of all open issues Number of my issues A pie chart of all the user s open issues sorted by type of issue Patient sample heartbeat The number of patient samples received daily by the AQURE system for the last 30 days The overview in this widget helps you to see if the number of patient sample measurements changed during a period of time QC heartbeat The number of QC results QC results with errors and QC results with range violations received by the AQURE system per day for the last 30 days The overview in this widget helps you to see if the number of QC measurements has changed during a period of time It also shows if an increased number of QC range violations or errors have occurred Related topics What is the Dashboard page 3 The Dashboard AQURE system instructions for use 4 Working with issues 3 What is an issue An issue tells you when it is necessary to do something to make sure your devices give accurate results and when it is necessary to train operators QC range and statistical period violations are examples of issues Related topics Issues created by the AQURE system page 41 How are issues created Issues are c
13. X shows that the evaluation of the parameter violated the rules The red X does not tell you if you are in compliance You see the compliance status in the bottom right corner of the report The table below the Levey Jennings plot shows the result of the statis tical evaluations A red SD cell in the Month to date row shows that the monthly SD is greater than 150 of the lot to date SD A red Bias cell in the Month to date row shows that the shift in bias from the period before is greater than the lot to date SD Text in right corner The text in the bottom right corner of the report tells you if the issue has been closed If there is no Reviewed by the issue is pending and you can be out of compliance Reports The reports available in the system are Report Description Calibration report This report shows all calibrations on one device during a period of time Control cycle evaluation This RiliB K report shows the evaluation of bias and imprecision for one control cycle The evaluation is shown as the root mean square deviation It shows the status for a device a parameter lot and level Current param eter range setup This report shows the QC ranges for all parameters on all QC levels on each device in a hospital The report shows a snapshot of the setup as it was when the report was generated Issues report This report shows all issues for a selected period of time Issues report QC range viola tions
14. a time range 1 Go to the Device center 2 If necessary use the filter sort group or search functions to see the device you want to see 3 Click the device 4 Enter the time range 5 Click the Filter button About accessing patient results You can access the patient result time line directly from the Device center or by clicking a measurement value from the patient result page You typically access a patient result time line from the Device center when you inves tigate device errors and want to see if they had an effect on patient results When you access the patient result time line from the patient result page you are typically inter ested in the patient result and want to see if it was influenced by device errors Related topics To see a patient result from the Device center page 25 To find a patient s results page 17 Patient result timeline The time line has symbols that show the status of the patient results measured in the selected period Symbol Description The patient result was accessed from the Device center and has no errors or range violations The patient result was accessed from the Device center and has at least one error or range violation The patient result was accessed from the patient result page and has no errors or range violations The patient result was accessed from the patient result page and has at least one error or range violation The Device center AQURE system
15. instructions for use 24 To see a patient result from the Device center This procedure lets you see if a device error has had an effect on patient results 1 Go to the Device center 2 Click the device that measured the patient result 3 If necessary change the Show data from period and click the Filter button 4 Click the Patient result bar 5 Click one of the red or blue squares You see the result values Related topics About accessing patient results page 24 Device messages Three types of messages are recorded Info message contains information about the status of a device Warning message contains warning information about the status of a device Critical message contains information about a critical event or status of a device To start an action on a device 1 Go to the Device center 2 Select a device and click Device actions 3 Select an action and fill in any fields 4 Click Send Related topics About the Device center page 23 Device actions for ABL90 FLEX analyzers page 42 Device actions for AQT90 FLEX analyzers page 43 Device actions for ABL800 FLEX and ABL700 series analyzers page 44 Device actions for ABL80 FLEX series analyzers page 45 Device actions for ABL5 analyzers page 46 To lock a parameter 1 Go to the Device center 2 Select a device 3 Select a parameter 4 Click Lock Related topics
16. lt device name gt See section 2 1 1 2 or section 2 1 6 1 RiliB K sections 2 1 1 2 and 2 1 6 1 require two QC meas urements within a calendar day of 24 hours Statistical period viola tion Normal Root mean square deviation for lt device name gt on lt param eter s gt is too high The root mean square deviation for the control cycle is greater than the allowed maximum root mean square deviation Statistical period viola tion Normal Statistical evaluation violation for lt device name gt on lt param eter s gt The monthly SD is greater than 150 of the lot to date SD and the difference in mean compared to the previous month s mean is greater than the lot to date SD Statistical period viola tion Normal Statistical evaluation violation for lt device name gt on lt param eter s gt The monthly SD is greater than 150 of the lot to date SD Statistical period viola tion Normal Statistical evaluation violation for lt device name gt on lt param eter s gt The difference in mean compared to the previous period s mean is greater than the lot to date SD Task Normal New device lt device name gt When a new device is connected to the system it must be regis tered Task Normal New operator lt oper ator name gt Operator lt operator name gt was not registered in the system when a QC result arrived from device lt device name gt Register the operator in
17. must log on as an Administrator The course must be in the Scorm 2004 format The course must be a zip file 1 Go to Administration gt Manage courses 2 Click the button to start to add a new course 3 If necessary deselect the Use title and description from course package if present box and enter title and description AQURE system instructions for use Administration 35 4 Click the Browse button 5 Select the course 6 Click the Open button 7 Click the button The course is added and saved Related topics About managing and assigning training courses page 35 To edit and publish a course Prerequisites You must log on as an Administrator You must have added the course 1 Go to Administration gt Manage courses 2 If the course has not been retracted withdrawn click the button 3 Click the button shown on the right side of the course title 4 Edit the title and or description 5 Click the button shown on the right side of the course title The course is saved 6 Click the button The course is published and can be assigned to operators You can click the button to start the course Related topics About managing and assigning training courses page 35 To retract and remove a course page 37 To publish a new version of a course Prerequisite You must log on as an Administrator When you publish a new version of a course
18. parts of the AQURE system you can search for 11 devices issues operators training course status and patient results List views AQURE system instructions for use 12 Inspection ready 5 About reports The system includes standard reports They can help you record the status of your POC devices to show compliance with your regulatory requirements You can see the reports online You can also print or attach them to e mails or export them in different file formats Related topics Links between reports page 13 Reports page 14 Links between reports The QC statistical evaluation overview shows an overview of the monthly quality control statistical evaluations You can select to see statistics from two months to one year Click on a square to open the QC statistical evaluation report and see more on bias and imprecision for a parameter on a device From the QC statistical evaluation report click a link to see details on parameter linearity or QC range violations The illustration below shows the links between the reports QC statistical evaluation overview QC statistical evaluation report QC statistics and linearity report Issues report QC range violation Related topics About reports page 13 13 Legend of QC statistical evaluation report Icon or text Explanation A green checkmark shows that the evaluation of the parameter did not violate any rules A red
19. related to the performance of devices to tell users of issues to be managed The AQURE system is intended for professional use 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 Introduction AQURE system instructions for use 2 The Dashboard 2 What is the Dashboard The Dashboard page is the first page you see when you log on The page shows widgets that are programs shown in small windows An example of a widget is the Latest QC status of all devices widget At the top right of the Dashboard you can use these buttons Edit widgets To edit add and remove a widget Change layout To change the layout of the Dashboard You can drag and drop the widget to move it The changed Dashboard layout and added widgets are there the next time you log on Related topics Widgets page 3 Graphical widgets page 3 Widgets There are two types of widget standard and graphical Related topics What is the Dashboard page 3 Standard widgets The system includes these standard widgets Widget Explanation Issue list These widgets show a list of the top 5 10 or 50 issues that are not closed Number of POCT devices This widget shows the number of point of care devices regis tered in the system
20. 100 issues per page 4 Click the Action button 5 Select actions and or enter text for the selected issues 6 Click the Save button About RiliB K rule violation issues Note These rules only apply to the German RiliB K setup of the AQURE system The AQURE system creates an issue when one of these RiliB K rules is violated Rule Description 16 hour rule 1 QC must be measured successfully within 16 hours before a patient result is measured 24 hour rule Within one calendar day on which a minimum of one patient sample has been measured a minimum of two different levels of QC must be measured successfully Unit use device rule Within a calendar week one QC must be measured successfully before a patient result is measured Low frequency device rule less than 15 QCs per 3 months Within one calendar day on which a minimum of one patient sample has been measured a minimum of two different levels of QC must be measured successfully Working with issues AQURE system instructions for use 8 About the add issue screen From Issues you use the Add issue button when you want to add an issue of the type Task or Maintenance You can also assign the issue to a person The summary text that you enter is shown in the Issues list An issue with the status resolved is solved but not closed You use this status when the person who corrects and records the issue is different from the person who closes it Rel
21. AQURE system Instructions for use from software version 1 7 Contents 1 Introduction 1 About the AQURE system 1 The help system 1 Intended use 2 Hazards 2 2 The Dashboard 3 What is the Dashboard 3 Widgets 3 Standard widgets 3 Graphical widgets 3 3 Working with issues 5 What is an issue 5 How are issues created 5 Understanding the issues workflow 5 To resolve an issue 6 To resolve a QC range violation issue
22. Description Calibration High Device lt device name gt Calibration failure Calibration failed on these parameters lt parameter name gt for device lt device name gt Device error High Device lt device name gt has an error All errors with the status Critical from Radiometer devices Operator performance High lt Number of failed operators gt out of lt total number of active operators gt operators did not satisfy the perform ance targets for lt month gt lt Number of failed operators gt out of lt total number of active operators gt operators did not do the required number of QC patient measurements and or they had too many QC patient measurements that failed in lt month gt QC range violation High QC range violation for lt device name gt on lt parameter s gt QC ranges for lt device name gt have been violated on the these parameter s lt parameter s gt Rule viola tion Normal Liquid QC missing for device lt device name gt Liquid QC for unit use device lt device name gt is missing See RiliB K section 2 1 5 2 Rule viola tion Low RiliB K rule violation on device lt device name gt See section 2 1 1 2 Device lt device name gt must do a QC measurement within 16 hours prior to patient measure ments See RiliB K section 2 1 1 2 41 Type Severity Summary Description Rule viola tion Low RiliB K rule violation on device
23. L90 FLEX analyzer 42 AQT90 FLEX analyzer 43 ABL80 FLEX series analyzer 45 send 25 Control cycle evaluation report 14 control cycle report 14 course assign 29 add 35 edit 36 manage 35 play 36 publish 36 remove 37 retract 37 search 29 status 30 test 36 Current parameter range setup report 14 D dashboard standard widgets 3 what is it 3 device collapse view 11 expand view 11 find 33 group 11 hide 33 access 31 add 32 show 33 device actions ABL5 analyzer 46 ABL700 series analyzer 44 ABL800 FLEX analyzer 44 ABL90 FLEX analyzer 42 AQT90 FLEX analyzer 43 ABL80 FLEX series analyzer 45 device center device messages 25 time line 24 what is it 23 device details explore 23 device messages 25 F FLEXLINK delete data 20 edit sampler data 20 result page 20 sample registration 19 H hazards 2 help 1 hide device 33 home department 28 I input item double 34 integer 34 list 34 string 34 issue details explore 23 issue list widget 3 issue types 3 issues add 9 assign 9 automatically made 41 close 9 collapse view 11 corrective action 9 device messages 25 examples 5 expand view 11 explore 23 AQURE system instructions for use Index 51 filter 11 group 11 handle multiple 8 how are they created 5 list of 41 quick close 8 resolve
24. Ready state including ensuring the analyzer is correctly calibrated Unlock analyzer Unlocks the analyzer Return analyzer from Locked to Ready state Lock analyzer Locks the analyzer Calibra tions and QC schedules are not suspended Prevent analysis of blood samples This is particularly used if there is an analyzer problem Set analyzer message Displays a message on the screen of the analyzer Messages can be added edited or deleted To send a message to operators of the analyzer For example please use a different analyzer High crea check measure Checks the analyzer performance at a high crea tinine level Allows performance of an unsched uled high crea check either as part of a troubleshooting or just to satisfy a wish for an extra check Related topics About the Device center page 23 To start an action on a device page 25 To lock a parameter page 25 Device actions for ABL80 FLEX series analyzers Depending on the state of the analyzer you can send these device actions to the ABL80 FLEX series analyzers AQURE system instructions for use Reference information 45 Command Action on ABL80 FLEX series analyzer Purpose System cycle Initiates a calibration and 3 levels of automatic QC To troubleshoot a failed param eter Rinse Initiates a complete rinse of the analyzer To remove traces of a sample calibrating solution or a QC solu tion from the liquid transport s
25. ain in the Device center Related topics To add a device to a department page 32 To hide a device page 33 To hide a device Prerequisite You must log on as an Administrator 1 Go to the Device center and select the device 2 Click the Edit device button 3 Select the Hide box 4 Click the Save button Related topics About hidden devices page 33 About Administration page 31 To show a hidden device Prerequisite You must log on as an Administrator 1 Go to Administration 2 Click Hidden devices 3 Select the device you want to show and click the Edit device button 4 Deselect the Hide box 5 Click the Save button Configure parameter profiles About the parameter profile In Configure parameters profiles you can define profiles with parameters and input items for the FLEXLINK application The profile in the FLEXLINK application corre sponds to a test order that is sent to the analyzer when the operator scans the sampler ID AQURE system instructions for use Administration 33 The AQURE FLEXLINK system only works with Radiometer safePICO samplers ABL800 FLEX ABL80 FLEX and ABL90 FLEX analyzers To create a parameter profile Prerequisite You must log on as an Administrator This procedure lets you configure parameter profiles for the FLEXLINK sampler regis tration page 1 Go to Administration 2 Click Configure parameter profiles 3 Click the Add button 4
26. ated topics To create your own list view page 11 AQURE system instructions for use Working with issues 9 Working with issues AQURE system instructions for use 10 List views 4 About list views You can create and save your own list views with selected data You can create list views for devices issues operators and patient results For example you can save a view that shows all devices with a Warning status and a view that shows open issues with a High severity To create your own list view 1 Choose an option and follow the steps for it Option Steps Sort columns Click a column header to sort the contents in an alphanumerical sequence Filter items from a list a Click the Add filter buttons and select the items you want to see b Click Filter Sort by header only devices and issues You can also drag and drop headings inside that row Expand or collapse a view in a list sorted by header only devices and issues a Click the down arrow to collapse the view b Click the up arrow to expand the view 2 From the Select view drop down list select Save current view 3 Enter the name of the view and if you want the view to be the one you see the next time you enter the page click the Default box 4 Select the number of items for each page 5 Click Save Related topics About the add issue screen page 9 About Search From the respective
27. ce or tort including strict liability and even if Radiometer has knowledge of the possibility of the potential damage or loss Confidentiality The contents of this document shall not be reproduced or communicated to any third party without the prior written consent of Radiometer 49 Changes This document is subject to change without notice While every effort is made to ensure the correctness of the information provided in this document as changed from time to time Radiometer disclaims any liability for errors and omissions Trademarks Radiometer the Radiometer logo ABL AQT TCM RADIANCE AQURE PICO CLINI TUBES and QUALICHECK are trademarks of or used under license by Radiometer Medical ApS Legal notices AQURE system instructions for use 50 Index A ABL5 analyzer commands 46 device actions 46 ABL700 series analyzer commands 44 device actions 44 ABL80 FLEX series analyzer commands 45 device actions 45 ABL800 FLEX analyzer commands 44 device actions 44 ABL90 FLEX analyzer commands 42 device actions 42 add user 32 administration hide device 33 add device 32 all devices 23 AQT90 FLEX analyzer commands 43 device actions 43 AQURE system what is it 1 assign course 29 authorization operator 27 C calendar 26 Calibration report 14 cautions 2 close issue 9 commands ABL5 analyzer 46 ABL800 FLEX analyzer 44 AB
28. ck the Device messages button b Point the cursor to the message in the time line To see the status of the device and possibly do actions on it Click the Explore button and go to the Device center for more information or to do actions 6 Fill in the Root cause text field and click Save 7 Complete the corrective action AQURE system instructions for use Working with issues 7 8 Fill in the Corrective action text field and click Save 9 Make sure that the corrective action removed the root cause 10 Change the Status from In progress to Closed About the quick close function The Quick close button makes it easy to close issues fast You click the Quick close button to save changes you have made to the issue assign yourself to an issue if there is no assignee close the issue show the next issue in the filtered list of issues To handle multiple issues You can handle multiple issues in one operation 1 Go to Issues 2 Use the filter function to make a list of issues you are intrested in 3 Choose an option and follow the steps for it Option Steps To select all issues in the list Select the check box shown on the left side of the Type heading To select individual issues Select all necessary check boxes in the list Note you can only handle issues on one page at time If you choose to Save current view you can use the page count field to show a maximum of
29. data you want to see 3 Click the patient result You see a maximum of the 5 latest results for that patient 4 If necessary use the button to see previous results for the patient Related topics About accessing patient results page 24 To create your own list view page 11 The result page You open the result page from the Patient view list The result page has these buttons and symbols Buttons symbols Explanation A button used to show a maximum of 5 previous results A button used to show a maximum of 5 next results Show messages Hide messages A button used to show or hide error messages on the results with a question mark Show ranges Hide ranges A button used to show or hide the lower and upper limits of the reference range The range is shown in square brackets Information A button used to show or hide the Result status Sample type Sample number and Registration time 17 Buttons symbols Explanation More A button used to show or hide the Device type Comment Measuring mode and Sampler ID Measurement A button used to show or hide the values of the measured parameters Unknown A button used to show or hide unknown measurements An error occurred Result is above the reference range but below the upper critical limit Result is below the reference range but above the lower critical limit Result is above the upper critical limit but below the upper limit of the reportable ran
30. device of the same type to a department all operators in the depart ment with access to that type will automatically be given access to the new device About Administration You use Administration when you set up the system Here you can add change and remove your hospital and departments find change enable disable and remove users add new users show hidden devices add new reports for your system users manage courses set up FLEXLINK profiles Related topics To add a device to a department page 32 To hide a device page 33 31 User administration About user administration When you add users to the AQURE system they should be associated with hospital s and department s This lets them see all information related to their departments An administrator sees all the information available in the AQURE system and does not have to be associated with a department To add a new user Prerequisite You must log on as an Administrator 1 Go to Administration and click the Add users button 2 Enter the Personal details the Logon information and the Role s of the user 3 Select the operator box if the user is also to operate devices This action adds the operator in Operators 4 Click the Save button 5 Select the user s Hospital and Department 6 Click the Add button This lets the user see data associated with the user s department You can give the user acce
31. ect the device 3 Click the Edit device button 4 Click the Configure ranges button 5 Select the Parameter from the drop down list You can select the parameters that are not in the B1a table or have a target value outside the B1a range 6 Select the Level from the drop down list 7 Click the Restart calculations button Administration AQURE system instructions for use 38 My profile 11 To subscribe to issues 1 Go to My profile 2 Select the E mail box 3 Choose an option and follow the steps for it Option Steps To receive an e mail when an issue is changed or a new issue is added to the system Click the Subscribe to all issues link To receive an e mail when you add a new issue comment on an issue or when an issue is assigned to you Click the Subscribe to all issues related to me link 4 Click the Save button 39 My profile AQURE system instructions for use 40 Reference information 12 Issues that the AQURE system creates Issues created by the AQURE system The table shows the issue types that the AQURE system can create The text in angle brackets is replaced by a specific text received by the system The administrator of the AQURE system can for each issue type write standard oper ating procedures for the POC coordinators The administrator can also use the table to find out which issue types should be enabled for the hospital Type Severity Summary
32. es This is used if there is an analyzer problem Lock parameter Locks the parameter on the analyzer To prevent analysis of a parameter The message you enter will be shown on the analyzer screen and saved in the activity log of the analyzer Unlock param eter Unlocks the parameter on the analyzer Enables analysis of a parameter Unlock analyzer Unlocks the analyzer Return analyzer from Locked to Ready state Set analyzer message Shows a message on the screen of the analyzer Messages can be added edited or deleted To send a message to operators of the analyzer For example please use a different analyzer Related topics About the Device center page 23 To start an action on a device page 25 To lock a parameter page 25 Device actions for ABL800 FLEX and ABL700 series analyzers Depending on the state and type of the analyzer you can send these device actions to the ABL800 FLEX and ABL700 series analyzers Command Action on ABL800 FLEX and ABL700 series analyzer Purpose 1 point calibra tion Initiates a 1 point calibra tion of all parameters Recalibrate the analyzer all param eters 2 point calibra tion Initiates a 2 point calibra tion of all parameters Recalibrate the analyzer all param eters Rinse Initiates a complete rinse of the analyzer To remove traces of a sample cali brating solution or a QC solution from the liquid transport system Refill Tub
33. evices you can also see how many measurements failed and how many the operator is allowed to fail Three days after the end of the calendar month the AQURE system calculates the performance of the operators The period of three days gives operators time to register results from devices that have to be docked before they can send results to the AQURE system An issue is created if operators did not do sufficient QC measurements or patient samples or failed too many of them When you click the Explore button from the operator performance issue you go to the Operators page where you can lock out or change their lock out date on a device type If you close an operator s account the operator cannot access the device associated with that account You can also assign courses to operators Related topics To add operator data to the system page 27 To change the home department of an operator page 28 To send operator data to all devices page 28 To send operator data to one device page 28 To add operator data to the system From the Add operator page you give the operator access to device types in different departments Note From Administration gt Add user you can create a user of the AQURE system and an operator at the same time 1 Go to Operators and click the Add operator button 2 Fill in the Personal details the Logon information and select the Hospital and Home Department of the operator Note Operator name is
34. ge 24 About accessing patient results 24 Patient result timeline 24 To see a patient result from the Device center 25 Device messages 25 To start an action on a device 25 To lock a parameter 25 Calendar 26 9 Operator administration 27 About operator administration 27 To add operator data to the system 27 To change the home department of an operator 28 To send operator data to all devices 28 To send operator data to one device 28 To deactivate an operator or change the operator s lock out date 29 To close an operator s account
35. ge Result is below the lower critical limit but above the lower limit of the reportable range Result is above the upper limit of the reportable range but below the upper limit of the range of indication No result is available Result is below the lower limit of the reportable range but above the lower limit of the range of indication No result is available Result is outside the range of indication of the analyzer No result is available To see device performance when the patient sample was measured This procedure lets you see QC results and device messages created when the patient sample was measured 1 Go to Patient view 2 Click the patient result you want to examine 3 Click a measurement value or the symbol The Device center opens 4 Move the cursor to the icon 5 Choose an option from the patient result time line Levey Jennings graph or the Device messages and follow the steps for it Option Steps To see an overview of the patient QC result or to see the device message Put the cursor on the result icon To see a QC target value Put the cursor on the dashed line To see details about a patient QC result Cick the result icon Patient view AQURE system instructions for use 18 AQURE FLEXLINK system 7 What is the AQURE FLEXLINK system The AQURE FLEXLINK system is part of Radiometer s 1st Automatic solution and lets you register patient operator and sampler ID data a
36. ing refill Refills the transport system with liquid from all consum able bottles To remove any possible air bubbles from the calibration solutions LS adjust Liquid sensor adjust Fills and empties the liquid transport system To measure and adjust the Empty and Full sensor settings for all Liquid Sensors Cleaning Initiates a complete cleaning program Clean all pathways where blood or quality control solutions can travel Particularly for removing built up protein lipid or other blood prod ucts Reference information AQURE system instructions for use 44 Command Action on ABL800 FLEX and ABL700 series analyzer Purpose Pump s cali bration Pumps can be rotated and calibrated Ensure correct function of the pumps During troubleshooting helps to eliminate the possibility of a damaged pump tubing Interrupt activity Interrupts any initiated function currently running on the analyzer regardless of whether remotely or locally initiated Return analyzer from Busy to Ready state Enter standby Enters analyzer into standby Calibration and QC schedule is suspended Reduce consumption of solutions when the analyzer is not being used Enter StandBy Enter date and time you wish the analyzer to automatically exit standby Exit standby Exits standby The highest rated pending or overdue calibration is initiated within three minutes of exit standby Return analyzer from stand by to
37. it replaces the old course Operators keep their course status from the previous version of the course 1 Go to Administration gt Manage courses 2 Click the button shown on the right side of the course you want to republish The course is retracted 3 Click the button 4 If necessary edit the title and description of the course 5 Click the Browse button and go to the new version of the course 6 Select the course and click the Open button 7 Click the button The course is saved 8 Click the button The course is published Administration AQURE system instructions for use 36 To retract and remove a course Prerequisite You must log on as an Administrator When you retract a published course it is not available to operators When you remove a retracted course it is deleted from the Manage courses list in Administration The course history is not deleted 1 Go to Administration gt Manage courses 2 Click the button shown on the right side of the course you want to retract 3 Click the button shown on the right side of the course you want to remove Related topics About managing and assigning training courses page 35 RiliB K control range configuration About RiliB K control ranges You only see the RiliB K control ranges pages if the system is set up to comply with the German RiliB K regulations When you use the RiliB K control ranges it is necessary to calculate
38. mandatory 3 Click Save 4 To add more departments select Hospital and Department and click Add 5 Select the operator Role for the device types The role comes from the device The operator has the same role on all devices of a type 6 Set the Lock out date for the device types The Lock out date is the date when the operator cannot operate the device 27 7 Select Active to give the operator access to the device type 8 Click the Save button Related topics About operator administration page 27 To change the home department of an operator 1 Go to Operators 2 Click the operator you want to edit 3 Select the new Home department of the operator from the drop down list 4 Click Save Related topics About operator administration page 27 To send operator data to all devices This procedure deletes all operator data on the devices and sends the operator data saved in the AQURE system to all devices 1 Go to Operators 2 Click Push all operators Related topics About operator administration page 27 To send operator data to one device This procedure sends operator data saved in the AQURE system to one device 1 Go to Device center gt lt the device you want to send data to gt 2 Click the Show operators link 3 Choose an option and follow the steps for it Option Steps To edit operator data a Click the operator you want to edit b Edit the
39. mbols and dates Explanation Registration time The time the result was registered in the AQURE FLEXLINK system The time shown at the top of each column Shows the registered time until the Measuring Time of the sample is received and shown Related topics About the result page page 20 To register a sample page 19 To see patient results With AQURE FLEXLINK system you can see a maximum of 6 registered patient results 1 Scan or enter operator ID 2 Scan or enter patient ID 3 Click the patient icon at the top of the screen AQURE system instructions for use AQURE FLEXLINK system 21 AQURE FLEXLINK system AQURE system instructions for use 22 The Device center 8 About the Device center From the Device center you can see the status of the devices connected to the system For some devices you can see if it is connected to the system see the parameter status see if there are open issues for the device send commands to it access reports from the selected device quickly access it edit it Note If a device is not connected to the system you will see the parameter status from the last time the device was connected You can group devices and filter devices When you use the filter you will only see devices with the selected status device type hospital and department Related topics Device actions for ABL90 FLEX analyzers page 42 Device actions f
40. nalyzer Cali brations and QC sched ules can still take place To prevent analysis of blood samples This is often used if there is an analyzer problem Lock parameter Locks the parameter on the analyzer To prevent analysis of a parameter The message you type is shown on the analyzer screen and saved in the activity log of the analyzer Unlock param eter Unlocks the parameter on the analyzer To enable analysis of a parameter Unlock analyzer Unlocks the analyzer To return analyzer from Locked to Ready state Set analyzer message Shows a message on the screen of the analyzer Messages can be added edited or deleted To send a message to operators of the analyzer For example please use a different analyzer Start built in QC Starts the internal solu tion s for the entered slot A B or C To evaluate analyzer performance to ensure the reliability accuracy and precision of patient sample results Related topics About the Device center page 23 To start an action on a device page 25 To lock a parameter page 25 Device actions for AQT90 FLEX analyzers Depending on the state of the analyzer you can send these device actions to the AQT90 FLEX analyzers AQURE system instructions for use Reference information 43 Command Action on AQT90 analyzer Purpose Lock analyzer Locks the analyzer Cali brations and QC schedules are not locked To prevent analysis of blood sampl
41. operator data c Click Save To add new operator a Click Add operator b Follow the instructions in To add operator data to the system 4 Go to the Device center gt lt the device you want to send data to gt 5 Click the Push operators button Related topics About operator administration page 27 Operator administration AQURE system instructions for use 28 To deactivate an operator or change the operator s lock out date 1 Click the Explore button from the Operator performance issue or go to Opera tors 2 Select the operators Note An empty cell below an operator s name indicates that the operator has access to more device types Select only the wanted device type for each oper ator 3 Select an option from the Actions drop down list 4 Click the Push all operators button To close an operator s account When you close an operator s account the operator cannot access any device type 1 Go to Operators 2 Select an operator 3 Click Close account To search for operators course status This procedure lets you show operators pending non assigned and or completed courses 1 Go to Operators 2 From the filter group click the Add filter button below the Courses title 3 Select the check boxes for the courses you want to search for 4 Select the status from the list 5 Click the Filter button Related topics About managing and assigning training c
42. or AQT90 FLEX analyzers page 43 Device actions for ABL800 FLEX and ABL700 series analyzers page 44 Device actions for ABL80 FLEX series analyzers page 45 Device actions for ABL5 analyzers page 46 To start an action on a device page 25 To lock a parameter page 25 To see all devices in a department You can see all devices in a department from the Device center and save the page 1 Go to the Device center 2 Drag the Hospital column header to the row above 3 Drag the Department column header to the row above 4 From the Select view drop down list select Save current view 5 Enter the name of the view 6 Select the number of items for each page 7 Click the Save button About issues explore view When you click the Explore button you are redirected to more information about the issue such as Patient results 23 Parameter status Levey Jennings plot Device messages Calibration trends on parameters Calibration status QC status Consumables Scheduled activities System messages Operator performance About the timelines For devices that support it the Device center has a timeline for Patient results the Levey Jennings plot and Device messages It lets you see the device activities and when they occurred in relation to each other This helps you find the root cause of an issue To find device data within
43. ors and push the operator data to all your devices You also monitor the performance of operators and assign courses Administration is where you add change and remove hospitals departments and users of the AQURE system You also manage courses and set up FLEXLINK profiles Help shows the user instructions for the AQURE system About shows the version of the AQURE system My profile lets you edit your user data and subscribe to issues The help system Click the Help tab shown in the menu bar of the AQURE system to access the online help This table describes the functionality of the symbols and buttons in the user interface of the help system Symbol and text buttons Function Shows the navigation tree Hides the navigation window Goes to the previous help page 1 Symbol and text buttons Function Goes to the next help page Prints the current help page Opens the pdf version of the manual Contents Shows the Table of Contents Index Shows the Index Search Shows the Search function Intended use For in vitro diagnostic use The AQURE system is intended to let you manage analytical devices and operator profiles The user can associate patient data with test data The system shows test results The system receives data from connected devices at the point of care or laboratory It can send test results to the HIS LIS The system lets you send commands to selected devices The system uses data
44. ourses page 35 To assign a training course Prerequisites The course has been published The person that assigns the course must have a valid e mail address 1 Go to Operators 2 Use the filter function to make a list of operators 3 Click the Courses radio button 4 Select the course from the Courses drop down list 5 Choose an option and follow the steps for it Option Steps To select all operators in the list Select the check box shown on the left side of the Operator name heading To select operators one by one Select all necessary check boxes in the list Note you can only assign operators on one page at a time If you select Save current view you can use the page count field to show a maximum of 100 oper ators per page 6 Click the Assign course button AQURE system instructions for use Operator administration 29 Related topics About managing and assigning training courses page 35 Course status The Operators page has symbols that show the status of operator courses Symbol Description One or more pending courses Put the cursor on the icon to see more information One or more courses were completed and passed Put the cursor on the icon to see when the course was completed and its success rate One or more courses were completed but not passed Put the cursor on the icon to see more information No pending courses No passed courses Operator administra
45. r lot and level To see details of a monthly evaluation click on a square QC status over view This report shows QC range evaluations for all the departments in all hospitals A red square shows a QC range violation on any given device in a department A green square shows that a device had no QC range violations Click on a red square to see which device had one or more QC range violations QC status per department This report shows QC range evaluations for all the devices in a department It shows the status of QC range evaluations per day and per device A red square shows one or more QC range viola tions Related topics About reports page 13 AQURE system instructions for use Inspection ready 15 Inspection ready AQURE system instructions for use 16 Patient view 6 About the patient view In Patient view you get a list of all patient results in the AQURE system You can save a set of filters as a view For example you can save a view that shows all patient results from a specific department or device When you click in the patient list you see the 5 latest results from that patient and can browse to all the patient s results Note The Patient ID is the unique patient identifier If you want to see more results from the same patient in one view they need to have the same Patient ID To find a patient s results 1 Go to Patient view 2 Use the filter sort group or search functions to see the
46. re 37 5 C List Example Arterial Venous for a drop down list of sample types 8 Enter a sort order This is the order in which the input items are shown on the FLEXLINK registration page 9 If necessary enter a default value For a list option the default value will automatically be selected in the drop down list 10 If necessary select from the list the parameter of the input item For example the input item ventilator settings could be attached to the param eter FIO2 11 Click the Save button Course administration About managing and assigning training courses In Manage courses you can add training courses to the AQURE system You can edit the title and description of the course and publish it You can also publish a new version of a course From Manage courses you can run a published course to ensure that it is OK You can retract a course to make it unavailable to operators and remove it from the course list In Operators you can assign a published course to operators The operators receive the invitation to the course by e mail If the operator has no e mail address the e mail will be sent to the person who has assigned the course Related topics To assign a training course page 29 To search for operators course status page 29 To add a course page 35 To edit and publish a course page 36 To retract and remove a course page 37 To add a course Prerequisites You
47. reated in two ways They are automatically generated by the system or by users who create them manually The system automatically creates issues when a connected device shows critical errors a QC result is received from an unknown operator a new device is connected to the system and requires your attention before it can be used a QC range violation occurs a calibration error occurs an operator performance error occurs a RiliB K rule is violated the evaluation of the monthly statistics fails Understanding the issues workflow You see issues in a list view When you select an issue you can edit it and assign the issue to a person Issues can have data such as graphs and measurement results that enable you to analyze them Some issues have an Explore button that shows more facts about the issue When you resolve an issue you correct it and record its root cause and corrective action When the issue is resolved the assignee can close it 5 Select an issue Assign Correct Close Explore Documentation To resolve an issue This is the general procedure to resolve an issue for example a Device error issue You can follow changes to an issue with the Subscribe to issue function 1 From Issues click the issue 2 Click the Assign to me button or select an assignee from the Assignee drop down lists 3 Change the Status from Open to In progress 4 Enter a comment about the i
48. ss to more hospitals and departments To unlock a user Prerequisite You must log on as an Administrator A user who has tried to log on to the AQURE system 5 times without success is auto matically locked out of the system The administrator can unlock the user 1 Go to Administration 2 Click List users 3 Click the user in the user list 4 Click Unlock user Device administration To add a device to a department Prerequisites You must log on as an Administrator The new device must be connected to the AQURE system 1 Go to Issues 2 Enter New device and click Search 3 Click the issue for the device 4 Click the Explore button 5 Click the Edit device button 6 Select the Hospital and Department of the device from the drop down lists Administration AQURE system instructions for use 32 7 Enter a name for the device 8 Click the Save button Related topics About hidden devices page 33 About Administration page 31 About hidden devices When you hide a device you cannot see it in the Device center For example you do this to remove a device from a department temporarily remove test devices limit the types of devices You can see the hidden device in Administration A hidden device continues to make issues if it is connected to the system When you deselect the Hide box you put the device back into operation You can then see it ag
49. ssue in the Comment box 5 Click the Explore button if you want to see more data about the issue 6 Fill in the Root cause text field and click Save 7 Complete the corrective action 8 Fill in the Corrective action text field and click Save 9 Make sure that the corrective action removed the root cause 10 Change the Status from In progress to Closed To resolve a QC range violation issue A QC range violation issue tells you that one or more parameters have violated the QC ranges You can follow changes to an issue with the Subscribe to issue function 1 From Issues click the issue 2 Click Assign to me or select an assignee from the Assignee drop down lists 3 Change the Status from Open to In progress 4 Enter a comment about the issue in the Comment box 5 Click Subscribe to issue or Unsubscribe from issue if you want or do not want to get an e mail when the issue is updated Working with issues AQURE system instructions for use 6 6 Choose an option and follow the steps for it Option Steps To exclude a QC parameter from the statistics Deselect the parameter you want to exclude To add a comment about the included or excluded parameter Enter text in the Include exclude comment box To see a graphical representation of the QC result Click the Levey Jennings plot button To see if device activities occurred at the same time as the QC range viola tion a Click
50. t the patient bedside with a barcode reader It links together and saves this data and when the patient sample has been measured the system sends the result to the bedside and or the HIS LIS system To register a sample The AQURE FLEXLINK system only works with Radiometer safePICO samplers ABL800 FLEX ABL80 FLEX and ABL90 FLEX analyzers You can scan a maximum of 6 samplers for a patient 1 WARNING Risk of patient mix up Scan or enter patient ID Check that the ID is entered correctly 2 Scan or enter the operator ID 3 WARNING Risk of patient mix up Scan or enter sampler ID Check that the ID is entered correctly 4 Tap the touchscreen or click the mouse to enter more data 5 WARNING Risk of incorrect treatment Check that the data is entered correctly for example the temperature and the FIO2 6 Tap or click OK 7 If necessary scan more samplers 8 Tap or click Register Related topics About the result page page 20 The result page page 20 19 To edit sampler data You can edit sampler data if you have not registered it 1 Choose an option and follow the steps for it Option Steps To edit the data for one sampler Tap in the sampler box and edit the data To delete the data for one sampler Tap the X in the sampler box To delete all data Tap the Reset button About the result page The result page shows a maximum of 6 measured patient results The la
51. tandby Exits standby The highest rated pending or overdue calibration is initiated within three minutes of exit standby Return analyzer from stand by to Ready state including ensuring the analyzer is correctly calibrated Unlock analyzer Unlocks the analyzer Return analyzer from Locked to Ready state Reference information AQURE system instructions for use 46 Command Action on ABL5 analyzer Purpose Lock analyzer Locks the analyzer Calibra tions and QC schedules are not suspended Prevent analysis of blood samples This is particularly used if there is an analyzer problem LS adjust Liquid sensor adjust Fills and empties the liquid transport system To measure and adjust the Empty and Full sensor settings for all Liquid Sensors Related topics About the Device center page 23 To start an action on a device page 25 To lock a parameter page 25 AQURE system instructions for use Reference information 47 Reference information AQURE system instructions for use 48 Legal notices 13 System performance The procedures described in this manual must be observed in order to ensure proper system performance and to avoid hazards Radiometer cannot provide or verify system performance characteristics if the system is not installed used and maintained in accordance with Radiometer procedures or if accessories not meeting the specifications provided by Radiometer are used Radiometer warran
52. test result is always shown to the left side You can use the right arrow to see older results and the down arrow to see all measurement values Related topics The result page page 20 To register a sample page 19 The result page The result page of the AQURE FLEXLINK system has these buttons symbols and dates Buttons symbols and dates Explanation A button used for approval of the result A button used to reject the result You must write a reject comment Toggle ranges A button used to show the lower and upper limits of the refer ence range The range is shown in square brackets Register new A button used to start a new registration session An error occurred Result is above the reference range but below the upper critical limit Result is below the reference range but above the lower critical limit Result is above the upper critical limit but below the upper limit of the reportable range Result is below the lower critical limit but above the lower limit of the reportable range Result is above the upper limit of the reportable range but below the upper limit of the range of indication No result is available Result is below the lower limit of the reportable range but above the lower limit of the range of indication No result is available Result is outside the range of indication of the analyzer No result is available AQURE FLEXLINK system AQURE system instructions for use 20 Buttons sy
53. the Device messages button b Point the cursor to the message in the time line To see if there is a trend in the analyt ical performance on all measured QC levels Click the Trend across levels button To see if there is a trend on other devices of the same type which use the same QC material Click the Trend across devices button To see the status of the device and possibly do actions on it Click the Explore button and go to the Device center for more informa tion or to do actions 7 Fill in the Root cause text field and click Save 8 Complete the corrective action 9 Fill in the Corrective action text field and click Save 10 Make sure that the corrective action removed the root cause 11 Change the Status from In progress to Closed To resolve a calibration issue A calibration issue tells you that a calibration failed for one or more parameters You can follow changes to an issue with the Subscribe to issue function 1 From Issues click the issue 2 Click Assign to me or select an assignee from the Assignee drop down lists 3 Change the Status from Open to In progress 4 Enter a comment about the issue in the Comment box 5 Choose and option and follow the steps for it Option Steps To see the calibration results on the measured parameters Click the Calibration result button To see if device activities occurred at the same time as the calibration issue a Cli
54. the laboratory established ranges for some parameters If these ranges are too narrow you can use the manufacturer ranges Related topics To change to manufacturer ranges page 37 To change to manufacturer ranges Prerequisites You must log on as an Administrator The AQURE system must be set up for RiliB K use The device must have received a minimum of one QC result Note When you change from laboratory established ranges to manufacturer ranges we recommend that you clear this with the regulatory authorities 1 Go to the Device center 2 Select the device 3 Click the Edit device button 4 Click the Configure ranges button 5 Select the Parameter from the drop down list You can select parameters that are not in the B1a table or have a target value outside the B1a range 6 Select the Level from the drop down list 7 Click the Use manufacturer ranges button Related topics About RiliB K control ranges page 37 AQURE system instructions for use Administration 37 To recalculate laboratory established ranges Prerequisites You must log on as an Administrator The AQURE system must be set up for RiliB K use The device must have transmitted a minimum of one QC result Note When you change from laboratory established ranges to manufacturer ranges we recommend that you clear this with the regulatory authorities 1 Go to the Device center 2 Sel
55. the system Task Low Operator missing lt device name gt The QC result has no operator You must add an operator to it Related topics What is an issue page 5 Device actions for Radiometer analyzers Device actions for ABL90 FLEX analyzers Depending on the state of the analyzer you can send these device actions to the ABL90 FLEX analyzers Reference information AQURE system instructions for use 42 Command Action on ABL90 FLEX analyzer Purpose Calibration Starts a calibration of all parameters To recalibrate the analyzer all parame ters Rinse Starts a complete rinse of the analyzer To remove traces of a sample cali brating solution or a QC solution from the liquid transport system Tubing refill Refills the transport system with liquid from all consumable bottles To remove possible air bubbles from the calibration solutions Liquid sensor adjust Fills and empties the liquid transport system To measure and adjust the Empty and Full sensor settings for all Liquid Sensors Cleaning Starts a complete cleaning program To clean all pathways where blood or quality control solutions can travel You use this to remove built up protein lipid or other blood products Pump calibra tion Rotates and calibrates the pumps To make sure that the pumps function correctly During troubleshooting helps to remove the possibility of a damaged pump tubing Lock analyzer Locks the a
56. tion AQURE system instructions for use 30 Administration 10 The AQURE hospital model About the AQURE hospital model The AQURE system uses a hospital and department structure to group devices and operators into a logical model The AQURE server can manage one or more hospitals Each hospital can have depart ments with devices and operators When you connect a device to the AQURE system for the first time you find the new devices in the Issues list and the Device center You must associate the device with a department in the hospital Frequently this is the department where the device is It can also be a department of your own making You can for example combine the OR and Recovery departments into a new department if the operators of these depart ments use the same devices When you add operators you associate them with their home department You select which device types they have access to and which role they have on each device type A role could be Operator on a device of the type ABL90 FLEX analyzer Such an oper ator can operate all ABL90 FLEX analyzers in her home department You can also give an operator access to devices in other departments The operator has always the same role on all devices of a type This also applies when the devices are in different departments If you move a device to a new department all operators of that device cannot use it until they are associated with that department If you add a new
57. ts that the data media on which the software included in the system is furnished is free from defects in material and workmanship under normal use for three 3 months from the date of delivery as evidenced by a copy of invoice or receipt Third party software By using the system you accept the terms of the Software License Agreement s of the provider s of the software as shown in the End User License Agreement s deliv ered with the AQURE system If you cannot accept the terms of the Software License Agreement s you should not use the system but immediately contact your provider for a return of the system and a refund of the purchase price Warranties and disclaimer Radiometer makes no warranties express or implied other than expressly stated Any warranties expressly stated in this document are conditional upon the system being installed used and maintained in accordance with Radiometer procedures including that only accessories meeting the specifications provided by Radiometer are used Radiometer disclaims any liability for system performance if the system is not installed used and maintained in accordance with Radiometer procedures or if acces sories not meeting the specifications provided by Radiometer are used Further Radiometer disclaims any liability for loss of data and direct consequential or other damages including loss of profit or loss of business whether such claim for damages is based upon contract negligen
58. ystem Lock analyzer Locks the analyzer Calibra tions and QC schedules are not suspended Prevent analysis of blood samples This is particularly used if there is an analyzer problem Unlock analyzer Unlocks the analyzer Return analyzer from Locked to Ready state Set analyzer message Displays a message on the screen of the analyzer Messages can be added edited or deleted To send a message to operators of the analyzer For example please use a different analyzer Related topics About the Device center page 23 To start an action on a device page 25 To lock a parameter page 25 Device actions for ABL5 analyzers Depending on the state of the analyzer you can send these device actions to the ABL5 analyzers Command Action on ABL5 analyzer Purpose 1 point calibra tion Initiates a 1 point calibration of all parameters Recalibrate the analyzer all parameters 2 point calibra tion Initiates a 2 point calibration of all parameters Recalibrate the analyzer all parameters Rinse Initiates a complete rinse of the analyzer To remove traces of a sample calibrating solution or a QC solu tion from the liquid transport system Enter standby Enters analyzer into standby Calibration and QC schedule is suspended Reduce consumption of solutions when the analyzer is not being used Enter StandBy Enter date and time you wish the analyzer to automatically exit standby Exit s
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