Radiometer Aqure User Manual
Contents
1. 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 e To assign a training course page 29 e To search for operators course status page 29 e To add a course page 35 e To edit and publish a course page 36 e To retract and remove a course page 37 To add a course Prerequisites e You must log on as an Administrator e The course must be in the Scorm 2004 format e The course m2. Device error High Device device name gt All errors with the status Critical has an error from Radiometer devices Operator High Number of failed Number of failed operators performance operators out of out of total number of active total number of operators operators did not do active operators the required number of QC operators did not patient measurements and or satisfy the perform they had too many QC patient ance targets for measurements that failed in month month QC range High QC range violation for QC ranges for device name violation device name on have been violated on the these parameter s parameter s parameter s Rule viola Normal Liquid QC missing for Liquid QC for unit use device tion device device device name is missing See name RiliBAK section 2 1 5 2 oa viola Low RiliBAK rule violation Device lt device name gt must do ion a QC measurement within 16 hours prior to patient measure ments See RiliBAK section 2 1 1 2 41 Reference information AQURE system instructions for use Type Severity Summary Description Rule viola Low RiliBAK rule violation RiliBAK sections 2 1 1 2 and tion on device device 2 1 6 1 require two QC meas name See section urements within a calendar day 2 1 1 2 or section of 24 hours 2 1 6 1 Statistical Normal Root mean square The root mean square deviation
3. List views About list VIEWS eeseem Hee To create your own list view Inspection ready Aboutreports ohani ae A a A R Links between reportS sess Legend of QC statistical evaluation report Reports scidit ee rag arando ad RR X da About Search aieas aaea menn 11 11 11 11 13 13 13 14 14 AQURE system instructions for use 6 Patient view 17 About the patient VIeW euet niea teu chet ede Eta a EM MEN NIRE 17 To find a patient s results sc rm hene ox cea nane R Ue eR au es 17 The result page uinneit RUM eire Mp Ra e EIE DEM E tiie b etur iine 17 To see device performance when the patient sample was measured 18 7 AQURE FLEXLINK system 19 What is the AQURE FLEXLINK system ssssssesesee memes 19 T o tegister a sample iiic em Een enr aX sive cube RUF E RR aiaa a AMAT 19 Io editsampler data 2er dienten xa daa e gua goku ERR E pasa dE EES 20 About tHE result PAGS iiis eterne te eren diena ti eia iiaa Ra Ra Fea dine 20 Ihe result page 15er khen ird kai E E RR ne erkekur s does eee 20 TO see patient resulES 2 iiec tere menant iare nae inae inae ER cies gia cae CORE REY 21 8 The Device center 23 About the Device center iecit rhe nixa xu RR ERR des ipea aea aae dra 23 To see all devices in a department sss meme 23 About issues explore VIEW cissciisebasvesvecaverisdececnddececncdeneateceatsteaveracsiee
4. No pending courses No passed courses Administration 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 y
5. 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 e About the Device center page 23 e To start an action on a device page 25 e 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 45 Reference information AQURE system instructions for use 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 system 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
6. Related topics e To add a device to a department page 32 e 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 e About hidden devices page 33 e About Administration page 31 To show a hidden device Prerequisite You must log on as an Administrator 1 Goto Administration Click Hidden devices Select the device you want to show and click the Edit device button Deselect the Hide box Click the Save button ye Py 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 33 Administration AQURE system instructions for use 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 Go to Administration Click Configure parameter profiles Click the Add button Enter the name of the parameter profile Enter the sort o
7. The system includes these Graphical widgets The Dashboard AQURE system instructions for use 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 e What is the Dashboard page 3 Working with issues 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 e Issues created by the AQURE system page 41 How are issues created Issues are created in two ways They are automatically generated by the
8. 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 e About the Device center page 23 e To start an action on a device page 25 e To lock a parameter page 25 Device actions for ABL5 analyzers 46 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 standby Exits standby The highest rated pending or overdue calibration is initiated within three minutes of exit standby Return an
9. training course status and patient results AQURE system instructions for use Inspection ready 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 e 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 Issues report linearity report QC range violation Related topics e About reports page 13 13 Inspection ready AQURE system instructions for use Legend of QC statistical evaluation report Icon or text Explanation v A green checkmark shows that the evaluation of the parameter did not violate any rules x A red X shows that the evaluation of the parameter v
10. 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 E a a 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 18 This procedure lets you see QC results and device messages created when the patient sample was measured 1 Goto Patient view 2 Click the patient result you want to examine 3 Click a measurement value or the symbol The Device center opens 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 Put the cursor on the result to see the device message 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 AQURE FLEXLINK system What is the AQURE FLEXLINK system The AQURE FLEXLINK system is part of Radiometer s 1st A
11. This helps you find the root cause of an issue To find device data within a time range 1 Goto 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 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 e To see a patient result from the Device center page 25 e To find a patient s results page 17 Patient result timeline 24 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 resul
12. button 5 Select actions and or enter text for the selected issues 6 Click the Save button About RiliBAK rule violation issues Note These rules only apply to the German RiliBAK setup of the AQURE system The AQURE system creates an issue when one of these RiliBAK 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 Within one calendar day on which a minimum of one patient rule less than 15 QCs sample has been measured a minimum of two different per 3 months levels of QC must be measured successfully AQURE system instructions for use Working with issues 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 e The summary text that you enter is shown in the Issues list e 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 Related topics e To create your own list vie
13. managing and assigning training courses page 35 To assign a training course Prerequisites e The course has been published e The person that assigns the course must have a valid e mail address MoR WON I Go to Operators Use the filter function to make a list of operators Click the Courses radio button Select the course from the Courses drop down list Choose an option and follow the steps for it Option Steps To select all operators in the Select the check box shown on the left side of list 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 Click the Assign course button 29 30 Operator administration AQURE system instructions for use Related topics e About managing and assigning training courses page 35 Course status The Operators page has symbols that show the status of operator courses Symbol Description ib One or more pending courses Put the cursor on the icon to see more information 30 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 9 One or more courses were completed but not passed Put the cursor on the icon to see more information
14. 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 negligence or tort including strict liability and even if Radiometer has knowledge of the possibility of the potential damage or loss Confidentiality The conte
15. 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 Index 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 51 Index filter 11 group 11 handle multiple 8 how are they created 5 list of 41 quick close 8 resolve 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 rec
16. 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 RiliBAK 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 Working with issues AQURE system instructions for use Select an issue Assign X Explore a Documentation Correct a Close 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 Change the Status from Open to In progress Enter a comment about the issue in the Comment box Click the
17. time for a device a parameter 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 e About reports page 13 15 Inspection ready AQURE system instructions for use 16 Patient view 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 Goto Patient view 2 Usethe filter sort group or search functions to see the data you want
18. EX analyzers 42 AQURE system instructions for use Reference information Command Action on ABL90 FLEX Purpose analyzer Calibration Starts a calibration of all To recalibrate the analyzer all parame parameters ters Rinse Starts a complete rinse To remove traces of a sample cali of the analyzer brating solution or a QC solution from the liquid transport system Tubing refill Refills the transport To remove possible air bubbles from system with liquid from all consumable bottles 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 analyzer 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 activi
19. Explore button if you want to see more data about the issue Fill in the Root cause text field and click Save Complete the corrective action Fill in the Corrective action text field and click Save Make sure that the corrective action removed the root cause 10 Change the Status from In progress to Closed panaunaw 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 From Issues click the issue Click Assign to me or select an assignee from the Assignee drop down lists Change the Status from Open to In progress Enter a comment about the issue in the Comment box 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 oP Poe AQURE system instructions for use Working with issues 6 Choose an option and follow the steps for it e 10 11 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 QC result To see a graphical representation of the Enter text in the Include exclude comment box Click the Levey Jennings plot button To see if device activities occurred at the same time as the QC range viola tion a Click the Device messages button b Poi
20. RADIOMETER KJ ft seraamin LA a Reports error 883 Device 1393 090R0026N0004 has an 17 JI new device 1393 090R0026N0004 gt 3 pe f Patent 213 4 siut Sample 15 3 Sampie ype Unk red AQURE system Instructions for use from software version 1 7 AQURE system instructions for use Contents 1 Introduction About the AQURE System estie eite tu exeo dew t ge aee eer eld ydo a FR IX EACHRMEMETEOCT T HEINE Intended se ick e ERR ERR ai eur E DK PERRO dusted dis Hazards ocu xen ie pines ux vIEt ger T E De NDA Siw T ov dev M AE E 2 The Dashboard Whatisthe Dashboard i45 ehh h hri e a exu aga ik iare aaa Mna Widgets ccc Standard widgets oce iex needs p ER dens RERO Re beers HE da ER GFaphical widgets ERE 3 Working with issues WhatiSsAN issue uses ds pied en eria i Rec ea da dvs Re ire aa irse c aae How are issues created icis taies eise a E e aA E ERRARE RE Esa Ra dados Understanding the issues workflow sss MEE TCDWLII IM To resolve a QC range violation issue ssssssesemmemem To resolve a calibration issue sssssssssssseese memes About the quick close function 1 sean kann nura nianu naar und tans To handle multiple ISSUES 12 sisse entente nune nnn en ayes d en nu Ran RR eR aan About RiliBAK rule violation issues sseseseenee nennen nnne About th add issue Screen id ee etn c qe baba D cria n a ad cede date
21. a Course sssssseseeeee RiliBAK control range configuration sccceeeecaeeeeeeeceeeaeeeeaes About RiliBAK control ranges ssseeeene eene To change to manufacturer ranges eee eeeeeee este eee ee este ea ees To recalculate laboratory established ranges 11 My profile To subscribe to issues siente ete O AE daw exa ri creep d rai e das 12 Reference information Issues that the AQURE system creates sessessseee Issues created by the AQURE system eee Device actions for Radiometer analyzers sese Device actions for ABL90 FLEX analyzers ssssse Device actions for AQT90 FLEX analyzers s sees Device actions for ABL800 FLEX and ABL700 series analyzers Device actions for ABL80 FLEX series analyzers 31 TUE 31 SR sam e ga Y 31 VaE ELA eR D aliens se 31 jsvi ga d aAYA QU G 32 ET 32 T 32 E ede uiu 32 j niadasvasAFadi ans 32 aarti dais 32 isawides ana Dein 33 TTE 33 re ta gie via gait 33 aiani 33 33 UU 34 DITS 34 TET 34 iid s eR ERN Aud 35 E deiner 35 TET 35 deck Co ga DN 36 ves gots Sans aa sas 36 ea riadia daia 37 E E 37 AEA 37 s ERES Pi a uy ons 37 TUI 38 39 Dest kadai wae vita 39 AQURE system instructions for use Device actions for ABL5 analyzers ssssssssseeem mene 46 13 Legal notices System perfo
22. alyzer 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 AQURE system instructions for use Reference information 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 Fills and empties the liquid sensor adjust transport system To measure and adjust the Empty and Full sensor settings for all Liquid Sensors Related topics e About the Device center page 23 e To start an action on a device page 25 e To lock a parameter page 25 47 Reference information 48 AQURE system instructions for use Legal notices System performance The procedures described in this manual must be observed in order to ensure proper system performance and to avoid hazards Radiometer cannot provide or verify system performance characteristics if the system is not installed used and maintained in accordance with Radiometer procedures or if accessories not meeting the specifications provided by Radiometer are used Radiometer warrants that the data media on which the software included in the system is furnished is free from defects in material and workmanship under normal use for three 3
23. anage courses Click the bd button shown on the right side of the course you want to republish The course is retracted Click the e button If necessary edit the title and description of the course Click the Browse button and go to the new version of the course Select the course and click the Open button Click the W button The course is saved Click the e button The course is published AQURE system instructions for use Administration 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 Goto Administration Manage courses 2 Click the Y button shown on the right side of the course you want to retract oo 3 Click the Wl button shown on the right side of the course you want to remove Related topics e About managing and assigning training courses page 35 RiliBAK control range configuration About RiliBAK control ranges You only see the RiliBAK control ranges pages if the system is set up to comply with the German RiliBAK regulations When you use the RiliBAK control ranges it is necessary to calculate the laboratory established ranges for some parameters If these ranges are too narrow you can use the manufacturer ranges Related topics e To change to manufacturer ran
24. de the B1a range Select the Level from the drop down list 7 Click the Restart calculations button noB UN em 38 My profile To subscribe to issues 1 Goto 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 4 Click the Save button Click the Subscribe to all issues related to me link 39 My profile 40 AQURE system instructions for use 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 Description Calibration High Device device name Calibration failure Calibration failed on these parameters parameter name for device device name on device device name See section 2 1 1 2
25. device and Click the Explore button and go to the Device center for more information or to do actions possibly do actions on it Click the Device messages button Point the cursor to the message in the time line Fill in the Root cause text field and click Save Complete the corrective action Working with issues AQURE system instructions for use 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 Goto 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 100 issues per page Click the Action
26. e 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 Li Hides the navigation window e Goes to the previous help page Introduction AQURE system instructions for use Symbol and text buttons Function c3 Goes to the next help page G 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 Hazards 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 related to the performance of devices to tell users of issue
27. eaetiees 23 About the timeliness denarii mne Ramis Na ia cea ae asa DAP RR ED die 24 To find device data within a time range s ssssssssssrsssrssrrsrrrssrrurrnnrrnnernnrenerrnns 24 About accessing patient results sssssssssssssseeeem menm 24 Patient result timeline 2 iren Rennen nenne hare r una areia Aaaa iaiT nes 24 To see a patient result from the Device center sssssesene 25 DEVICE MESSAGES iridio eu tia ke C ERR E CREAN SERATA REPERTA CYRRICE ERU HLATA 25 TO start an action on a deVICe isis eem Nankai Paai dd aa ed eR eR a ER esa ETa paga 25 TO lock a parameter ieu riu ruu ru prre na ARR Rake ENARRARE RR 25 Calenda annia ERE 26 9 Operator administration 27 About operator administration sess emen nennen 27 To add operator data to the system ssssssssssessee emnes 27 To change the home department of an operator s sese 28 To send operator data to all devices ssssssssemmemn 28 To send operator data to one device sssssssssseseeem enm 28 To deactivate an operator or change the operator s lock out date 29 To close an operator s ACCOUNE eiascciceesccnceccaenceseceenetectscesactacteataeeaeaseenanazes 29 To search for operators course status oe eee eect eect eee eee eee eee ee ee meme 29 To assign a tralning COURSE sroissser e errores wer Dus deir ec seine die eae ened 29 COUFSe statUs ss
28. eature works for all device types For Radiometer devices 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 e To add operator data to the system page 27 e To change the home department of an operator page 28 e To send operator data to all devices page 28 e 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 Goto Operators and click the Add operator button 2 Fill in the Personal details the Logon information and select the Hospital and Home Department
29. ges page 37 To change to manufacturer ranges Prerequisites e You must log on as an Administrator e The AQURE system must be set up for RiliBAK use e 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 Select the device Click the Edit device button Click the Configure ranges button Select the Parameter from the drop down list You can select parameters that are not in the Bla table or have a target value outside the Bla range Select the Level from the drop down list 7 Click the Use manufacturer ranges button po D a Related topics e About RiliBAK control ranges page 37 37 Administration AQURE system instructions for use To recalculate laboratory established ranges Prerequisites e You must log on as an Administrator e The AQURE system must be set up for RiliBAK use e 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 Select the device Click the Edit device button Click the Configure ranges button Select the Parameter from the drop down list You can select the parameters that are not in the Bia table or have a target value outsi
30. ils coca cea n D rs Ewa Ft raa aed baie ae ADR REPRE Ra Ka 30 AQURE system instructions for use 10 Administration The AQURE hospital model ssseseeemenee About the AQURE hospital model seeseeeeneee About Administration sssssessenm mmm User administration 4 iiese eene rennen nhat ra rx A ERE YR an About user administration sess To add a new User usine adie cd native ERRREYEEREXD EE ARIA To UNIOCK A USER inea ete eet r ee era meat aT Mare Device administration sss mme To add a device to a department sse About hidden devices triremen nia ia EKAN Tohideca deViCe exe iei debs ni sea exer RR mee E ERR d To show a hidden device sssseeseme Configure parameter profiles ssssseeen ee en eee es About the parameter profile oo eceeeeeeeee ee eee eset este eeeeeeaeees To create a parameter profile oo cee eeeeeeee esse eee esse eeeee teenies To add parameters to a profile oo eee eeeceeeee teste eeeee eee eeeee tees To add input items to a profile oo eee cece este ee eee ee eee eee Course administration ose ee eee ecee eee ee eect ee eee ee nmm About managing and assigning training courses ToO dddacOUElse err ERR ee ERROREM tee YA To edit and publish a course eesesenen mne To publish a new version of a course eene To retract and remove
31. iolated 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 SD 0 196 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 Reports 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 The reports available in the system are Report Description Calibration report This report shows all calibrations on one device during a period of time evaluation Control cycle This RiliBAK 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 t
32. ions 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 x 0 1 AQURE system instructions for use Inspection ready 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
33. n give the user access 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 2 3 4 Go to Administration Click List users Click the user in the user list Click Unlock user Device administration To add a device to a department 32 Prerequisites e You must log on as an Administrator e The new device must be connected to the AQURE system non WE Go to Issues Enter New device and click Search Click the issue for the device Click the Explore button Click the Edit device button Select the Hospital and Department of the device from the drop down lists AQURE system instructions for use Administration 7 Enter a name for the device 8 Click the Save button Related topics e About hidden devices page 33 e 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 e remove a device from a department temporarily e remove test devices e 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 again in the Device center
34. nt 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 Fill in the Root cause text field and click Save Complete the corrective action Fill in the Corrective action text field and click Save Make sure that the corrective action removed the root cause 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 ms NM 6 7 From Issues click the issue Click Assign to me or select an assignee from the Assignee drop down lists Change the Status from Open to In progress Enter a comment about the issue in the Comment box 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 b To see the status of the
35. nts of this document shall not be reproduced or communicated to any third party without the prior written consent of Radiometer 49 Legal notices AQURE system instructions for use 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 50 AQURE system instructions for use 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 ABL90 FLEX analyzer 42 AQT90 FLEX analyzer 43 ABL80 FLEX series analyzer 45 send 25 Control cycle evaluation report 14 control cycle
36. of the operator Note Operator name is mandatory Click Save 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 Setthe Lock out date for the device types The Lock out date is the date when the operator cannot operate the device Dew 27 Operator administration AQURE system instructions for use 28 7 Select Active to give the operator access to the device type 8 Click the Save button Related topics e About operator administration page 27 To change the home department of an operator Go to Operators Click the operator you want to edit Select the new Home department of the operator from the drop down list Click Save nb odi m Related topics e 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 Goto Operators 2 Click Push all operators Related topics e 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 Goto Device center the device you want to send data to 2 Click the Show operators link 3 Choose an option and follow the steps for it Option Steps To editroperat
37. or data a Click the operator you want to edit b Edit the 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 Goto the Device center gt lt the device you want to send data to gt 5 Click the Push operators button Related topics e About operator administration page 27 AQURE system instructions for use Operator administration To deactivate an operator or change the operator s lock out date 1 2 Click the Explore button from the Operator performance issue or go to Opera tors 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 Select an option from the Actions drop down list 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 2 3 Go to Operators Select an operator Click Close account To search for operators course status This procedure lets you show operators pending non assigned and or completed courses 1 no m Go to Operators From the filter group click the Add filter button below the Courses title Select the check boxes for the courses you want to search for Select the status from the list Click the Filter button Related topics e About
38. ord 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 messages 25 my issues widget 3 number of issues by type widget 3 number of POCT devices 3 Oo 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 52 AQURE system instructions for use 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 14 QC stat evaluation overview 14 QC statistical evaluation 13 14 QC statistics and linearity 14 QC status overview 14 QC status pe
39. ou add a new 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 e To add a device to a department page 32 e To hide a device page 33 31 Administration AQURE system instructions for use 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 2 A Go to Administration and click the Add users button Enter the Personal details the Logon information and the Role s of the user Select the operator box if the user is also to operate devices This action adds the operator in Operators Click the Save button Select the user s Hospital and Department Click the Add button This lets the user see data associated with the user s department You ca
40. parameter 4 Click Lock Related topics e About the Device center page 23 e Device actions for ABL90 FLEX analyzers page 42 e Device actions for AQT90 FLEX analyzers page 43 e Device actions for ABL800 FLEX and ABL700 series analyzers page 44 e Device actions for ABL80 FLEX series analyzers page 45 e Device actions for ABL5 analyzers page 46 25 The Device center Calendar AQURE system instructions for use 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 Description Calendar J 1 e 26 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 Operator administration 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 f
41. pe hospital and department Related topics e Device actions for ABL90 FLEX analyzers page 42 e Device actions for AQT90 FLEX analyzers page 43 e Device actions for ABL800 FLEX and ABL700 series analyzers page 44 e Device actions for ABL80 FLEX series analyzers page 45 e Device actions for ABL5 analyzers page 46 e To start an action on a device page 25 e 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 Go to the Device center Drag the Hospital column header to the row above Drag the Department column header to the row above From the Select view drop down list select Save current view Enter the name of the view Select the number of items for each page Click the Save button aS DSN m About issues explore view When you click the Explore button you are redirected to more information about the issue such as e Patient results 23 The Device center AQURE system instructions for use 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
42. period viola deviation for device for the control cycle is greater tion name on param than the allowed maximum root eter s is too high mean square deviation Statistical Normal statistical evaluation The monthly SD is greater than period viola violation for device 150 of the lot to date SD and tion name on param the difference in mean compared eter s to the previous month s mean is greater than the lot to date SD Statistical Normal statistical evaluation The monthly SD is greater than period viola violation for device 150 of the lot to date SD tion name on param eter s Statistical Normal statistical evaluation The difference in mean compared period viola violation for device to the previous period s mean is tion name on param greater than the lot to date SD eter s Task Normal New device device When a new device is connected name to the system it must be regis tered Task Normal New operator oper Operator operator name was ator name not registered in the system when a QC result arrived from device device name Register the operator in the system Task Low Operator missing The QC result has no operator device name You must add an operator to it Related topics e 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 FL
43. r 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 WwW warnings 2 widget add 3 change layout 3 issue list 3 latest QC status of all devices 3 move 3 AQURE system instructions for use 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 Index 53 Index AQURE system instructions for use 54 RADIOMETER i If you have any questions or need assistance please contact your local Radiometer representa tive Radiometer representative Code number 995 086 Version 201302E C vo Radiometer Medical ApS 2700 Br nsh j Denmark http www radiometer com 2013 Radiometer Medical ApS All rights reserved
44. rder of the profile Click the Save button pum PW To add parameters to a profile Prerequisite You must log on as an Administrator 1 Goto Administration Click Configure parameter profiles Click a profile in the list Click the Add button Select the parameter from the drop down list and click the Add parameter button Repeat step 4 for more parameters Click the Save button nR WUN 9 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 Goto Administration Click Configure parameter profiles Click a profile in the list Click the Add button below the Input items heading Enter the name for the input item This is the name that is shown on the FLEXLINK sampler registration page 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 e UNN m 34 AQURE system instructions for use Administration 7 Choose from these options Option Description Text Example operator name Number Example 21 for the FIO2 9o Floating point Example 37 5 for the temperature 37 5 C number List Example Arterial Venous for a drop down list of sample types
45. rmance Third party software Warranties and disclaimer Confidentiality Changes eeen Trademarks Index 5i Introduction 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 e 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 e Operators is where you add device operators and push the operator data to all your devices You also monitor the performance of operators and assign courses e Administration is where you add change and remov
46. s to be managed The AQURE system is intended for professional use 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 A Death or injury to persons CAUTION A Equipment damage The Dashboard 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 e Edit widgets To edit add and remove a widget e 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 e Widgets page 3 e Graphical widgets page 3 Widgets There are two types of widget standard and graphical Related topics e 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 RSS feed This widget shows the RSS feed from the entered web page Graphical widgets
47. sult is available HEZEHEZBEH Result is outside the range of indication of the analyzer No result is available 20 AQURE system instructions for use AQURE FLEXLINK system Buttons symbols Explanation and dates Registration time The time the result was registered in the AQURE FLEXLINK system The time shown at Shows the registered time until the Measuring Time of the the top of each sample is received and shown column Related topics e About the result page page 20 e 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 21 AQURE FLEXLINK system AQURE system instructions for use 22 The Device center 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 ty
48. t page and has at least one error or range violation onm AQURE system instructions for use The Device center 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 Click the device that measured the patient result If necessary change the Show data from period and click the Filter button Click the Patient result bar Click one of the red or blue squares You see the result values pom a Related topics e About accessing patient results page 24 Device messages Three types of messages are recorded e Info message contains information about the status of a device e Warning message contains warning information about the status of a device e Critical message contains information about a critical event or status of a device To start an action on a device Go to the Device center Select a device and click Device actions Select an action and fill in any fields Click Send BM ME Related topics e About the Device center page 23 e Device actions for ABL90 FLEX analyzers page 42 e Device actions for AQT90 FLEX analyzers page 43 e Device actions for ABL800 FLEX and ABL700 series analyzers page 44 e Device actions for ABL80 FLEX series analyzers page 45 e Device actions for ABL5 analyzers page 46 To lock a parameter 1 Go to the Device center 2 Select a device 3 Select a
49. t the result page To delete all data Tap the Reset button The result page shows a maximum of 6 measured patient results The latest 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 e The result page page 20 e 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 Explanation and dates A button used for approval of the result BE 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 re
50. 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 e About the Device center page 23 e To start an action on a device page 25 e 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 Initiates a 2 point calibra Recalibrate the analyzer all param cleaning program tion tion of all parameters eters Rinse Initiates a complete rinse of To remove traces of a sample cali the analyzer brating solution or a QC solution from the liquid transport system Refill Tubing Refills the transport system To remove any possible air bubbles refill with liquid from all consum from the calibration solutions able bottles LS adjust Fills and empties the liquid To measure and adjust the Emp
51. to see 3 Click the patient result You see a maximum of the 5 latest results for that patient If necessary use the button to see previous results for the patient Related topics e About accessing patient results page 24 e 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 Patient view AQURE system instructions for use 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
52. ty Liquid sensor transport system and Full sensor settings for all adjust Liquid Sensors Cleaning Initiates a complete Clean all pathways where blood or quality control solutions can travel Particularly for removing built up protein lipid or other blood prod ucts 44 AQURE system instructions for use Reference information on the analyzer regardless of whether remotely or locally initiated Command Action on ABL800 FLEX Purpose and ABL700 series analyzer Pump s cali Pumps can be rotated and Ensure correct function of the bration calibrated pumps During troubleshooting helps to eliminate the possibility of a damaged pump tubing Interrupt Interrupts any initiated Return analyzer from Busy to Ready activity function currently running 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 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
53. ty 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 Shows a message on the To send a message to operators of the message screen of the analyzer analyzer For example please use a Messages can be added different analyzer edited or deleted Start built in Starts the internal solu To evaluate analyzer performance to QC tion s for the entered ensure the reliability accuracy and slot A B or C precision of patient sample results Related topics e About the Device center page 23 e To start an action on a device page 25 e 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 43 Reference information AQURE system instructions for use Command Action on AQT90 analyzer Purpose Lock analyzer Locks the analyzer Cali brations and QC schedules are not locked To prevent analysis of blood samples 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
54. ust be a zip file z Go to Administration gt Manage courses 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 35 Administration mno AQURE system instructions for use Click the Browse button Select the course Click the Open button Click the W button The course is added and saved Related topics e About managing and assigning training courses page 35 To edit and publish a course Prerequisites e You must log on as an Administrator You must have added the course Go to Administration Manage courses If the course has not been retracted withdrawn click the Y button Click the e button shown on the right side of the course title Edit the title and or description Click the W button shown on the right side of the course title The course is saved Click the e button The course is published and can be assigned to operators You can click the o button to start the course Related topics e About managing and assigning training courses page 35 e To retract and remove a course page 37 To publish a new version of a course 36 Prerequisite You must log on as an Administrator When you publish a new version of a course it replaces the old course Operators keep their course status from the previous version of the course 1 2 Sm Go to Administration M
55. utomatic solution and lets you register patient operator and sampler ID data at 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 6 7 8 WARNING Risk of patient mix up Scan or enter patient ID Check that the ID is entered correctly Scan or enter the operator ID WARNING Risk of patient mix up Scan or enter sampler ID Check that the ID is entered correctly Tap the touchscreen or click the mouse to enter more data WARNING Risk of incorrect treatment Check that the data is entered correctly for example the temperature and the FIO2 9 6 Tap or click OK If necessary scan more samplers Tap or click Register Related topics e About the result page page 20 e The result page page 20 19 AQURE FLEXLINK system To edit sampler data AQURE system instructions for use 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 Abou
56. w page 11 Working with issues AQURE system instructions for use 10 List views 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 N 4 5 Choose an option and follow the steps for it Option Steps Sort columns Filter items from a list Click a column header to sort the contents in an alphanumerical sequence 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 From the Select view drop down list select Save current view 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 Select the number of items for each page Click Save Related topics e About the add issue screen page 9 About Search From the respective parts of the AQURE system you can search for 11 List views 12 devices issues operators
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