Home

Operator`s Manual CoaguChek XS Plus

Contents

1. 20 0 Observed Test Sequence OTS e nana arrancan corran 139 141 Operating CONAIIONS m 19 127 Operator le per 64 Operator laica 85 116 A o E IO A 47 55 o A 128 Overview Meter elements ss id dido dad 20 P passwol ucbe sol bangetu M C LI UnPuudneDtup LLL LIEU E UE e 85 ng 65 PAULO NIG MASE ERR ETE 88 117 oM 24 Power on Power supply Charging terminals Handheld Base Unit eeettnnnnnncas 21 Product specifications ice e peces A 127 Putting the meter into operation e nana erronea ttttttttts 26 28 Q QC Range aU Ad 69 QC Setting E 68 73 Quality Control Nur UM o o a a a eeaatmerteercanate 72 86 MINI E 113 Prepaid sist io indiano d dile 98 Res iii A de 106 145 Index R Relative hiblfmidiby ssepe teo oido tuts E re Eee ES ep EEUE 19 127 A 21 Result confirmation sssssscsssssessssssssessssssssessssssscsssssssesssssssscsesssuscsessssssesesssusessessssscsessnsecsesssssecsesssnecesesssseeeesss 39 94 Review Results Data transfer Roche Addresses e as 137 S Safety Protection against infection cinnnnnnnn aa 16 User qualification SA oia Setup Admin PASS ume a 58 63 o A Display format S PET iU o AAA AP A Langua
2. essences 79 Getting a good result from venous whole blood 79 Preparing tO test di leaeiad 80 Test strip code chip 81 Inserting the code chip Powering on the meter 83 PEO MIND A Sic 86 Accepting or rejecting a test result occiso 94 Adding COMME Scan ida dias scale 95 6 Control Testing and Quality Control 97 Preparing to run a liquid quality control test essent 98 Performing a liquid quality control test tetttttnnnnnncas 100 7 Review Results 109 Viewing test ISSN iaa 110 Display patient result memory ttt ttttttettnnn 112 Display QC quality control result memory nnns 113 8 Extended Functionalities 115 BEWEIS I e oda 115 Computer Setup option we 115 Operator lists 116 Patient lists s aa 117 Stored test results and comments eene 118 9 Cleaning and Disinfecting the Meter 119 Recommended cleaning disinfecting solutions s 119 Cleaning disinfecting the exterior meter housing 120 Cleaning disinfecting the test strip guide tnt 121 10 Troubleshooting 123 Additional information on Error AOB caciones 124 Errors and unusual behavior without error messages s 125 11 General Product Specifications 127 Technicalidata acosado illa E ias 127 A idi e need i tain te trete
3. 29 Putting the Meter into Operation This page intentionally left blank 30 Meter Setup 4 Meter Setup Note on presentation of screen elements in this manual Buttons are screen prompts that cause something to happen when touched The names of all buttons are either shown as bold text or as the icon used on the button eg for OK Other screen elements e g Menu titles are written in italics These screen elements are not active If you have not set the date and time after powering on for the first time or because the bat teries were removed from the meter for more than 10 minutes you cannot perform a test In that case powering on the meter takes you immediately to the Setup mode where you must set the date and time see page 41 and following After date and time have been set the meter automatically moves to the Main Menu where you can start a test or enter more settings You can open any displayed function by touching or tapping the button for it with your finger or a special pen for this purpose Tap means Touch the button then remove your finger from the touchscreen The next screen appears once you remove your finger If the meter did not automatically enter the Setup mode e g after the batteries were replaced you can open the Setup menu from the Main Menu METEO 09 15 am 1 Touch Setup to open the meter settings e 2 Selectthe group of settings of choice see the Settings sum
4. 14 Safety Information dct ere t ANA 16 Disposal OF the Systir ERdebndaead 17 General Cate E 18 Electromagnetic Interference coccion 18 Bere as 18 Operating Conditions iii 19 Quality COMOL m 19 2 The CoaguChek XS Plus Meter 20 Overview of the meter elements esee ttt 21 Buttons and icons overview aa 22 POIS Ae 24 3 Putting the Meter into Operation 26 Inserting the batteries cc 27 Powering the meter on and off Checking the software version 29 4 Meter Setup 31 Note on presentation of screen elements in this manual 31 ise e 32 Ner e 36 Contrast 36 Result Units 237 Result Confirmation 39 Language Selection 40 Setting the date Al Setting the time 43 Setting the display options for date and time 45 Options S tUp aos 47 SOME AA enn o e 47 A 49 fI p tenon 52 CONMECHON aient tede te nod duct saben ted red sas 54 D SUP ii AR 56 System Administrator Admin itte 58 Operatoria a ine MUERE LUI 64 Patient D scaena o b p erinnere dr Por arare 65 QC Settings setup 68 QC Range 69 QC quality control Lockout 72 Operator LOCK OVE iras 74 5 Testing a Blood Sample 77 IMPONE MOLES scarico fetet loses 77 Getting a good capillary blood sample
5. 81 82 DAS YUVA O ENE E X 81 Code TUDES Ties be 82 Comments A avai 95 Computer 55 Connection 55 Contrast 36 Control solution huie Code chip Preparing eene D pent eh CAST meer 115 Pr e 41 Pine M 119 122 143 Index Display ro PP oO E OO OE OOOO 22 23 Display Matas 45 Disposaliaica calcio oia nicho 17 25 79 96 107 E Error MOSS Sii ic 123 F la sipiore e M H 91 l Icons Dropin e A E 90 Bele 104 A 90 104 Identification Plate e 5 D 22 23 PACA anche 5 PES 56 67 Overview 2 56 Infrared BE Cessna a ai 21 115 K ML 84 M Mams WO Ute nata 19 127 Measurement Pero MINO suicidado biota es REL dite 86 96 Preparing POP on A O a N 80 Measuring range ide anotada dada 93 127 144 Index Memory Me 111 Patient Relais 112 esae P 113 Meter Qu
6. 2 04 19 2012 E 04 19 2012 E Meter Setup 6 Use the arrows to to set the allowed per centage deviation from the target value Use the arrows on the left to adjust the whole number before the decimal point Use the arrows on the right to adjust the number after the decimal point 7 Touch Y to save this setting or touch X to exit this menu without saving any changes The display automatically returns to the QC Settings screen The Custom Range and Target Value if set to On appear in a line below the control test result in the QC test and QC memory screens In the left hand screen Display target value is set to Off the custom range only is displayed below the control test result In the right hand screen Display target value is set to On both the custom range and the target value are displayed The target value here 2 9 appears in front of the custom range 71 Meter Setup QC quality control Lockout The QC Lockout ensures that the optional quality control tests are run on a regular basis This is independent of the operator however This option should be used if you work without oper ator lists lt is also possible to mandate Operator Lockouts and QC Lockouts in parallel In addi tion to defining time intervals QC Lockout can also be used to specify that a quality control test must be carried out when a new test strip lot is used New Code ATTE 09 15am 1 From the
7. eR Review Results Setup i 09 15 am ls Patient Test 7 ER 04 19 2012 om Control Testing and Quality Contro Check the battery level If the battery icon turns red one bar left there may not be enough power left for another test If there are no bars left in the battery icon you cannot perform any more tests Power the meter off using the D button In both cases restore power by inserting new batteries recharging the battery pack or using the power adapter Check that the date and time are correct Correct any wrong entries as described in Chapter 4 Meter Setup Setting the date Touch Control Test 101 Control Testing and Quality Contro MICA 00 7 Thetest strip icon prompts you to insert a cma BEIM test strip Remove a test strip from its con tainer and close the container again with xa the stopper 8 Holdthe test strip so the lettering with the ij test name is facing upward 9 Slidethe test strip into the test strip guide in the direction indicated by the arrows 04 19 2012 G amp G Slide the test strip in as far as it will go A beep tone indicates that the meter has detected the test strip provided the beeper is enabled Exposure to external influences such as humidity may deteriorate the test strips and may lead to error messages Therefore always close the container immediately after removing a test strip 102
8. POINT O F OCINE TESTING CoaguChek XS Plus Operator s Manual CoaguChek XS Plus Operator s Manual 0 5021464001 05 2012 05 USA The contents of this manual including all graphics and photographs are the property of Roche Diagnostics No part of this document may be reproduced or transmitted in any form or by any means electronic or mechanical for any purpose without the express written permission of Roche Diagnostics Roche Diagnostics has made every reasonable effort to ensure that all the information contained in this manual is correct at the time of printing However Roche Diagnostics reserves the right to make any changes necessary without notice as part of ongoing product development This manual was created by the Roche Diagnostics Commercial Education department Direct questions or concerns regarding the contents of this document to Roche Diagnostics Commercial Education Department 9115 Hague Road P O Box 50457 Indianapolis IN 46250 0457 USA ACCU CHEK COAGUCHEK and SAFE T PRO are trademarks of Roche All other trademarks are the property of their respective owners O 2007 2012 Roche Diagnostics US Order Number 0 0521464001 05 2012 05 USA This document is available electronically at www poc roche com On the packaging and on the identification plate of the instrument you may encounter the following symbols shown here with their meaning A z e LOT REF
9. 04 19 2012 04 19 2012 65 Meter Setup You may select from the following options W No tests will be assigned numbers automatically Optional W Optional automatic numbering or Required list manual input tu 04 19 2012 W Required list manual input 4 Touch the button with the setting of choice Your selection is now highlighted 5 Touch Y to save this setting or touch X to exit this menu without saving any changes The settings for the option No are now completed For the options Optional and Required continue by selecting the input format 66 Patient ID 09 15 am Alphanumeric Min Length Max Length 1 20 04 19 2012 E 6 Meter Setup Select the form for input of the Patient ID You may select from the following options Alphanumeric Enter any combination of letters and numbers e g J DOE 3378 Numeric Enter numbers only e g 3387 Min Length Enter the minimum number of characters 1 20 the Patient ID must have Max Length Enter the maximum number of characters 1 20 the Patient ID can have Touch the button with the format of choice for the Patient D Your selection is now highlighted Touch D or H to set the number of characters length of choice Touch Y to save this setting or touch X to exit this menu without saving any changes The display automatically returns to the
10. Op Operator 1 18A ul imi ED 04 19 2012 B 09 15 am New Code 4 QC 070 QC 060 QC 050 QC 048 X 04 19 2012 ith B 09 15 am Code 184 Par PT Op Operator 1 m Lx 04 19 2012 Em Control Testing and Quality Control If you are using a new test strip lot and have not inserted the test strip code chip yet you must do so now Otherwise you cannot per form a quality control test As with the test strips a quality control code chip is also provided with the control solu tions This chip informs the meter about the acceptable ranges of results for that lot of controls The information on the code chip is retained in the memory so you can use the same control solutions at any time 10 Select the code stored for your current control solution or touch New Code to use a new control solution The first time you run a control the meter skips this QC Test screen option because there are no code chip parameters in memory yet The next time you use the control this screen will display offering you a pick of the code s already stored as well as the option New Code Ifyou are using a new control solution remove the strip code chip from the meter and insert the code chip that came with the control solu tion instead If the code chips get mixed up check the letter on the code chips to tell them apart A capital S in front of the n
11. 40 50 60 Connection Default settings are labeled with an asterisk 34 Off Computer Meter Setup Group Subgroup Setting Values ID Setup Admin Administrator Blank Off Operator Operator List is optional Active Inactive Patient No Optional Required QC Settings QC Range Default Range Custom Range Display Target Value On Off Deviation from Target Value Percentage Operator Lockout only if the Operator option is set to Active and an operator list is available Off Weekly Monthly Every 3 months Every 6 months Yearly QC Lockout New code Yes No General No Daily Weekly Monthly Default settings are labeled with an asterisk 35 Meter Setup Screen setup The Screen setup area contains the options for changing the display Contrast Use the Contrast menu to adjust the display to your ambient light conditions and make it easier to read y Patient Test P Control Test eR A Setup Review Results w a 2 e E 2 3 04 19 2012 Setup Menu Screen Options ID Setu 09 15 am Screen 09 15 am Contrast QC Settin Result Units Result Confirmation 04 19 2012 Language Selection Date Time DIED 04 19 2012 36 09 15 am Co
12. License incorporates the limitation as if written in the body of this License 9 The Free Software Foundation may publish revised and or new versions of the General Public License from time to time Such new versions will be similar in spirit to the present version but may differ in detail to address new problems or concerns 132 Each version is given a distinguishing version number If the Program specifies a version number of this License which applies to it and any later version you have the option of following the terms and conditions either of that version or of any later version published by the Free Software Foundation If the Program does not specify a version number of this License you may choose any version ever published by the Free Software Foundation 10 If you wish to incorporate parts of the Program into other free programs whose distribution conditions are different write to the author to ask for permission For software which is copy righted by the Free Software Foundation write to the Free Software Foundation we sometimes make exceptions for this Our decision will be guided by the two goals of preserving the free status of all derivatives of our free software and of promoting the sharing and reuse of software generally NO WARRANTY 11 BECAUSE THE PROGRAM IS LICENSED FREE OF CHARGE THERE IS NO WARRANTY FOR THE PROGRAM TO THE EXTENT PERMITTED BY APPLICABLE LAW EXCEPT WHEN OTHER WISE STATED IN WRITING THE COPYRI
13. The Patient ID is set to No but there is a list available The list of Patient IDs is always shown when starting a test You may now select a patient from the list create a new patient entry by touching New Instead of an ID a consecutive number will be assigned to this result The Patient ID is set to Optional or Required and there is a list available The list of Patient IDs is always shown when starting a measurement You may now select a patient from the list create a new patient entry by touching New You may enter a new ID via the onscreen keypad The Patient ID is set to hidden only possible with a data management system and there is a list available A blank list is shown when starting a measurement You may now create a new patient entry by touching New and entering a new ID via the onscreen keypad When working with Patient lists you have the following options A Patient ID does not have to be on the list to be used The meter displays a warning that the Patient D entered is not on the list The meter displays an error message that the ID was not found on the list of valid Patient IDs You must enter a valid ID to proceed 117 Stored test results and comments When performing a test the test result will be stored along with additional information including the Patient ID Operator ID the kind of test performed and optional Comments The meter comes with a default set of Comments that can be assigned to
14. and blood taken from a new puncture site at the tip of another finger Do not touch or remove the test strip when a test is in progress Note on Error 406 The CoaguChek XS PT Test strip may be used for patients under a combina tion therapy of oral anticoagulants plus heparin injections For maximum heparin concentrations which do not interfere with the test refer to the package insert Under no circumstances how ever should heparinized capillary tubes be used for sample application If capillary tubes are used use only the dedicated CoaguChek capillary tubes Be sure to apply the blood drop to the test strip within 15 seconds of lancing the fingertip In rare cases patients with long clotting times gt 8 INR lt 5 Quick may receive an Error 406 message on the meter display If this error message appears again when the test is repeated the result must be checked using another method 124 Troubleshooting Errors and unusual behavior without error messages Some conditions may arise that have no associated error or status message Message Description No message or unusual behavior Meter display does not W Wait 10 seconds and try powering on the unit again power on W Check that the meter has power f you are using the external power adapter is it connected properly to the meter Or Place the meter in the Handheld Base Unit Or f you are using the Handheld Battery Pack is it properly installed in the me
15. Software Foundation s software and to any other program whose authors commit to using it Some other Free Software Foundation software is covered by the GNU Library General Public License instead You can apply it to your programs too When we speak of free software we are referring to freedom not price Our General Public Licenses are designed to make sure that you have the freedom to distribute copies of free software and charge for this service if you wish that you receive source code or can get it if you want it that you can change the software or use pieces of it in new free program and that you know you can do these things To protect your rights we need to make restrictions that forbid anyone to deny you these rights orto ask you to surrender the rights These restrictions translate to certain responsibilities for you if you distribute copies of the software or if you modify it For example if you distribute copies of such a program whether gratis or for a fee you must give the recipients all the rights that you have You must make sure that they too receive or can get the source code And you must show them these terms so they know their rights We protect your rights with two steps 1 copyright the software and 2 offer you this license which gives you legal permission to copy distribute and or modify the software Also for each author s protection and ours we want to make certain that everyone understands that there is
16. W 00 120 5 B Sec 9 6 96 Results that are above or belowthe measuring range are indicated by the symbols gt above or lt below If a c is displayed along with the result This may occur if the hematocrit value is very low or due to erroneous blood collection e g wet hands Repeat the measurement and make sure that the patient s hands are dry If the message persists perform a hematocrit check When interpreting results refer to the detailed information on limitations and interferences included in the limitations section of the test strip package insert 93 Testing a Blood Sample Accepting or rejecting a test result AA e If this function is enabled you may choose to Oi Opa accept or reject a test result When the result es is displayed touch 2 5 mr i W Rejector 210 J W Accept Measurement Result OK 04 19 2012 E If you reject a result you must enter a com 1 009 ment with an explanation A comment is required if you reject a result Please enter a comment E 09 15 am A If you reject the result this test result is no map oed longer displayed However the test entry is Par PT Code 184 04 19 2012 09 14 am stored Rejected Will Repeat Test g o Ems 04 19 2012 Adding comments Testing a Blood Sample You can add up to three comments to a test result Comments can provide for example addi tional information about the tes
17. due to handling and procedure errors Depending on the circumstances a message may appear on the display of the meter These messages are marked with an icon either Li for a status message or e for an error mes sage All messages displayed by the system are accompanied by a description of the error and a possible solution Take the action suggested on screen to resolve the problem If the error disappears you may continue using the meter as desired If the problem persists contact Roche see page 137 The two different message types are illustrated below Message Description 1 001 Battery Low Battery Low Status message i 1 001 Touch Y to proceed with the next step The battery is getting low Replace or recharge battery pack as soon as possible E 101 Patient ID Required Patient ID Required Error message Q E 101 Ah Touch X to exit this message Perform the suggested step s to A patient ID is required solve the problem Enter a valid patient ID Cx 123 Troubleshooting E 406 Sample Error Sample Error Error message E 406 Touch X to exit this message Perform the suggested step s to Unsuitable sample solve the problem composition Check your procedure and repeat the test with a fresh sample Check medication regimen of patient Additional information on Error 406 Power the meter off and remove the test strip Repeat the measurement using a new test strip
18. exclusion of warranty and each file should have at least the copyright line and a pointer to where the full notice is found One line should give the program s name and an idea of what it does Copyright C yyyy name of author This program is free software you can redistribute it and or modify it under the terms of the GNU General Public License as published by the Free Software Foundation either version 2 of the License or at your option any later version 133 General Product Specifications This program is distributed in the hope that it will be useful but WITHOUT ANY WARRANTY without even the implied warranty of MERCHANTABILITY or FITNESS FOR A PARTICULAR PUR POSE See the GNU General Public License for more details You should have received a copy of the GNU General Public License along with this program if not write to the Free Software Foundation Inc 51 Franklin Street Suite 330 Boston MA 02110 USA Also add information on how to contact you by electronic and paper mail If the program is interactive make it output a short notice like this when it starts in an interactive mode Gnomovision version 69 Copyright C year name of author Gnomovision comes with ABSO LUTELY NO WARRANTY for details type show w This is free software and you are welcome to redistribute it under certain conditions type show c for details The hypothetical commands show w and show c should show the appropriate parts of th
19. is established in two steps The meter connects to the Handheld Base Unit via infrared The Handheld Base Unit is either connected to a single computer via USB or to a network host system via ethernet The option Computer when activated can be used together with a DMS to set up a operator lists or patient lists lists of patients to be tested This eliminates the need for manual entry of these data In addition you can transfer test results stored in the meter to other systems for archiving or further evaluation The option Computer controls the meter s ability to communicate with a computer or a network META 09 15 am 4 Touch Computer Your selection is now highlighted 5 Touch Y to save this setting or Computer touch X to exit this menu without saving any changes The display automatically returns to the previous Screen a 3 04 19 2012 Extended data handling functionality is dependent on the capabilities ofthe particular Data Management System DMS being used and may vary For more information on DMS please contact your Roche representative 55 Setup ID setup Use the D Setup menu to enter settings for user management and patient management These settings are optional and set to Off Inactive by default the meter can be operated without these settings There are three types of identification used with the meter System Administrator The Admin Administrator has special ri
20. no warranty for this free software If the software is modified by someone else and passed on we want its recipients to know that what they have is not the original so that any problems introduced by others will not reflect on the original authors reputations 129 Finally any free program is threatened constantly by software patents We wish to avoid the danger that redistributors of a free program will individually obtain patent licenses in effect making the program proprietary To prevent this we have made it clear that any patent must be licensed for everyone s free use or not licensed at all The precise terms and conditions for copying distribution and modification follow TERMS AND CONDITIONS FOR COPYING DISTRIBUTION AND MODIFICATION This License applies to any program or other work which contains a notice placed by the copy right holder saying it may be distributed under the terms of this General Public License The Pro gram below refers to any such program or work and a work based on the Program means either the Program or any derivative work under copyright law that is to say a work containing the Program or a portion of it either verbatim or with modifications and or translated into another language Hereinafter translation is included without limitation in the term modifica tion Each licensee is addressed as you Activities other than copying distribution and modification are not covered
21. passed Pass Fail Measurement Result OK Reject Accept Comment gt m 04 19 2012 Supplement for Observed Test Sequence Operator 1 Touch Patient Test Perform the patient test as usual Once the test is completed the observer has to com plete the next steps 2 Hand the meter back to the observer Observer 3 Touch Y to log in again 4 After you enter your password touch to proceed with the assessment 5 Assess the operator s performance by touching Pass or Fail 6 Assess the test result by touching Accept or Reject 7 Touch D to add a comment 8 Touch Y to return to the Pat Test OTS screen The OTS information is saved together with the test result 141 Supplement for Observed Test Sequence This page intentionally left blank 142 Index Index A Adapter power SUPpply sssscccssssssssscescecessssseseessecesssntseeeseeeesnueeessecessnumseeseeeecesnuasenenseeeesnuuaseeeeeeeeesnuanneeeeseeee 24 Admin PASS WO Aia doi ata 58 63 Applying a blood sample anna 91 PANVICE O pM CERE 52 B Batteries Insertion a aio 27 O 25 A ER 49 89 102 Blood sample testing enana 77 96 C Capillary blood sample testing 77 96 Ip 119 122 Meter HOUSING iia 120 TestStip quide ac ias 121 Coagulation PROCESS miii Mund eM A A UAE 91 enc m
22. selected the desired com ment s touch Y to return to the results screen After the test result is displayed touch 8 You will be prompted to remove the strip 18 Remove the test strip from the meter If you are performing a 2 level control you will now be asked to proceed with the second level 19 Power the meter off 20 Remove the quality control code chip from the meter and store it with the controls 21 Clean the meter if this becomes necessary see Chapter 9 Cleaning and Disinfecting the Meter Dispose of controls and used test strips from control testing in accord ance with the disposal policy of your facility The control solution con tains animal material which should be considered as potentially infectious 107 Control Testing and Quality Control This page intentionally left blank 108 Review Results 7 Review Results The CoaguChek XS Plus meter can save 2000 patient test results as well as 500 liquid quality control tests to memory together with respective time and date In addition up to 60 code chip records contents of test strip code chips and control solution code chips are stored If you are using operator and or patient lists a maximum of 5000 Operator and 4000 Patient IDs is allowed If memory is full when you perform a test the oldest result is automatically deleted The most recent result is always saved This applies both to patient results and to quality control test
23. the dropper to the bottle Make sure that the dropper does not come into contact with the dried control plasma 8 Close the bottle again 9 Make sure the dropper is at hand for the next steps in the liquid quality control test 10 Swirl the bottle using a circular motion to completely dissolve all of the control plasma inside Do not shake the bottle or turn it on its side Doing so can cause components in the control plasma to stick to the sides of the bottle Let the bottle sit undisturbed for 1 minute Please refer to the control solution package insert The control solution is now ready to be applied to the test strip The control solutions may be reconstituted mixed after removal from the refrigerator The resulting solution may be used up to 30 minutes after reconstitution 99 Control Testing and Quality Control Performing a liquid quality control test 100 La p ur sa Patient Test Control Test Review Results Setup 09 15 am 04 19 2012 B 1 Place the meter on a level vibration free surface or hold it in your hand so it is roughly horizontal 2 Power the meter on by pressing the O button for approximately 1 second You can also power on the meter directly by inserting a test strip or connecting the power adapter 3 Wait until the Main Menu is displayed or log on as described on page 84 Main Menu E a Patient Test B Control Test
24. to modify or distribute the Program or its derivative works These actions are prohibited by law if you do not accept this License Therefore by modifying or distrib uting the Program or any work based on the Program you indicate your acceptance of this License to do so and all its terms and conditions for copying distributing or modifying the Pro gram or works based on it 6 Each time you redistribute the Program or any work based on the Program the recipient automatically receives a license from the original licensor to copy distribute or modify the Pro gram subject to these terms and conditions You may not impose any further restrictions on the recipients exercise of the rights granted herein You are not responsible for enforcing compli ance by third parties to this License 7 If as a consequence of a court judgment or allegation of patent infringement or for any other reason not limited to patent issues conditions are imposed on you whether by court order agreement or otherwise that contradict the conditions of this License they do not excuse you from the conditions of this License If you cannot distribute so as to satisfy simultaneously your obligations under this License and any other pertinent obligations then as a consequence you may not distribute the Program at all For example if a patent license would not permit royalty free redistribution of the Program by all those who receive copies directly or indirectly thro
25. 012 E Meter Setup The current setting is highlighted You may select from the following options For the Beeper Off Low Medium High For the Key Click On Off Touch the button with the desired setting forthe Beeper then touch the button with the setting of choice for the Key Click Both selections are now highlighted Touch Y to save this setting or touch X to exit this menu without saving any changes The display automatically returns to the previous screen 51 Meter Setup Auto Off You can set up your CoaguChek XS Plus meter so that it powers itself off automatically if it has not been used no buttons touched or tests run for a preselected time period Use this feature to save power and extend the life of the batteries 1 From the Main Menu touch Setup to open the meter settings 2 From the Setup Menu touch Options From the Options menu touch Auto Off 2 o a 2 B Patient Test 2 Control Test wm Review Results Setup 04 19 2012 09 15 am Options ID Setup QC Settings 04 19 2012 09 15 am Beeper Auto Off Connection 8 Te tn 04 19 2012 If the meter is connected to the power adapter or the Handheld Base Unit the Auto Off function has a different effect W If you work with operator IDs the meter switches to Operator Login once Auto Off is t
26. 04 15 2012 10 01 am PIDO1 04 14 2012 10 03 am Mid e 1 04 19 2012 09 15 am P ID PIDO1 Smith Henry Op Operator 1 Par PT Code 184 04 18 2012 11 31 am 2 51 21 Q Doctor Notified Sick Travel 04 19 2012 112 Cm 09 15 am P ID PIDOT Smith Henry 04 18 2012 11 31 am 2 5 INR 21 Q 04 17 2012 10 15 am 3 0 INR 16 Q 04 16 2012 09 58 am 1 7 INR 38 Q 5 tle 04 19 2012 This memory area contains all test results for your patients sorted according to the setting you chose for the option Sort see page 47 If the Sort option is set to Date Time the most recent results are at the top of the list 1 Touch D and H to scroll to the entry of choice on the screen 2 Touch the entry you want to open The entry is displayed 3 Touch 4 The results for the selected patient are displayed Review Results Display QC quality control result memory This memory area contains all liquid quality control tests that were run sorted chronolog ically The most recent results are at the top of the list 1 Touch D and o to scroll to the entry of choice on the screen 2 g a 2 04 18 2012 11 31 am 999 Pass 2 Touch the entry you want to open 04 17 2012 10 05 am 234 Pass 2 2 ge oF a Di S o o D D 04 16 2012 10 07 am 623 Pass 04 15 2012 10 30 am QC 333 Pass 04 14 2012 11 01 am 432 P
27. 9 15 am Screen ID Setup QC Settings Admin 09 15 am 04 19 2012 09 15 am Operator Mp B 04 19 2012 E Meter Setup Deactivating an existing Admin pass word 1 From the Main Menu touch Setup to open the meter settings 2 From the Setup Menu touch ID Setup 3 Using the keypad displayed on the screen enter the valid Admin password The D Setup menu is displayed The Admin button is highlighted which means an Admin password is active 4 Touch Admin 5 Immediately touch Y to close the keypad on the screen without entering a password The Admin password has been deleted and therefore deactivated The Admin button is no longer highlighted 63 Q Meter Setup Operator ID If you want to create a list of Operator IDs from which you can select an operator additional software a data management system and the Handheld Base Unit are required for more details see Data handling starting on page 115 In the default setting the Operator login is not activated You can either activate or deactivate Operator login on the meter If activated an Operator has to log in before the Main Menu will be displayed and measurements can be performed To activate Operator login 09 15 am 1 From the Main Menu touch Setup to open the meter settings Main Menu
28. A batteries or the special Roche handheld battery pack This can lead to incor rect battery power level indications on the meter 26 Inserting the batteries Putting the Meter into Operation 1 With the meter powered off press the battery compartment cover release tab and slide the cover off 2 Insert the four batteries in the battery compartment as indicated The batteries should last about 80 tests depending on the type of battery used 27 Putting the Meter into Operation 3 Slide the battery compartment back onto the meter and close it The meter powers itself on after the batteries have been inserted Powering the meter on and off 1 Place the meter on a level vibration free surface or hold it in your hand so it is roughly horizontal 2 Power the meter on by pressing the O button for approximately 1 second You can also power on the meter directly by inserting a test strip or connecting the power adapter 3 To power the meter off after use press the button for approximately 1 second 28 Putting the Meter into Operation Checking the software version AA After displaying the Roche logo the meter briefly displays the nit for initialization CoaguChek H h k hi h ft XS Plus screen Here you can check which software version is currently running on your meter The Init screen shown here is for illustration purposes only Version numbers on your meter may differ 03 01 00
29. CoaguChek XS Plus meter displays test results in units equivalent to laboratory plasma measurements Results may be displayed in three ways International Normalized Ratio INR combination of INR seconds or combination of INR Quick INR is a standardized measurement of the rate at which blood clots A low INR can indicate an increased risk of blood clots while an elevated INR can indicate increased risk of bleeding 12 The meter guides you through the test step by step using icons and instructions on the display Each box of test strips has its own code chip that you insert into the meter This code chip con tains lot specific information about its test strips such as the expiration date and calibration data Optional liquid controls for the system are also available The CoaguChek XS Plus meter has the ability to connect to a data management system DMS through the Handheld Base Unit from Roche available separately The CoaguChek XS Plus meter supports data exchange via the POCTIA standard Data management systems may have the ability to expand the security features of the meter such as enabling operator lockouts Data management systems may also enable data transfer to an LIS or HIS Refer to the manuals of the Handheld Base Unit and of your DMS for technical details Test principle The CoaguChek XS PT Test used as directed with the CoaguChek XS Plus meter will provide an electrochemical measurement of prothrombin tim
30. D Control Test 2 From the Setup Menu touch ID Setup 3 Fromthe D Setup menu touch Operator 09 15 am Setup Menu Screen Options ID Setup AA ID Setup 04 19 2012 04 19 2012 09 15 am Operator is it 04 19 2012 4 Touch the button with the setting of choice for setting up the Operator login Your selection is now highlighted Touch Y to save this setting or e touch X to exit this menu without saving any changes The display automatically returns to the previous screen m it 04 19 2012 64 Meter Setup Patient ID If you want to create a list of Patient IDs from which you can select a patient for testing addi tional software a data management system and the Handheld Base Unit are required see page 115 In the default setting input of Patient IDs is set to No This means each test is simply assigned a consecutive number However you can require that a Patient ID be entered or make it optional 1 From the Main Menu touch Setup to open the meter settings 2 From the Setup Menu touch ID Setup 3 From the D Setup menu touch Patient 09 15 am Main Menu B Patient Test Control Test E ur 09 15 am etup Menu 04 19 2012 Options ID Setup Li 09 15 am ID Setup
31. Ensure that no air bubbles are introduced into the sample Protection against infection L N When collecting samples always observe the general precautions and guidelines relating to blood sampling see page 16 Dispose of all test strips used for patient testing in accordance with the disposal policy of your laboratory or practice see page 16 79 Testing a Blood Sample Preparing to test 1 Have the test strip container at hand 2 Make sure that the code chip supplied Mit with these test strips is at hand CODE KMAIKOE Bu DAQuChek xs prie 5 184 Ld Lor Each pack of test strips contains a code chip The number on the code chip and the number on the test strip container must match A capital S in front of the number indicates that this code chip is for test strips A capital C in front of the number indicates that it is a control solution code chip See Chapter 6 Control Testing and Quality Control 80 Testing a Blood Sample Test strip code chip The code chip provides the meter with important information that it needs to perform the coagu lation test The chip contains information about the test method the lot number and the expira tion date The code chip is required whenever a new test strip lot is used so that the meter can read and store the lot information about that particular lot of test strips The CoaguChek XS Plus meter stores the data from up to 60 code chips that have b
32. GHT HOLDERS AND OR OTHER PARTIES PROVIDE THE PROGRAM AS IS WITHOUT WARRANTY OF ANY KIND EITHER EXPRESSED OR IMPLIED INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE THE ENTIRE RISK AS TO THE QUALITY AND PERFOR MANCE OF THE PROGRAM IS WITH YOU SHOULD THE PROGRAM PROVE DEFECTIVE YOU ASSUME THE COST OF ALL NECESSARY SERVICING REPAIR OR CORRECTION 12 IN NO EVENT UNLESS REQUIRED BY APPLICABLE LAW OR AGREED TO IN WRITING WILL ANY COPYRIGHT HOLDER OR ANY OTHER PARTY WHO MAY MODIFY AND OR REDISTRIB UTE THE PROGRAM AS PERMITTED ABOVE BE LIABLE TO YOU FOR DAMAGES INCLUDING ANY GENERAL SPECIAL INCIDENTAL OR CONSEQUENTIAL DAMAGES ARISING OUT OF THE USE OR INABILITY TO USE THE PROGRAM INCLUDING BUT NOT LIMITED TO LOSS OF DATA OR DATA BEING RENDERED INACCURATE OR LOSSES SUSTAINED BY YOU OR THIRD PAR TIES OR A FAILURE OF THE PROGRAM TO OPERATE WITH ANY OTHER PROGRAMS EVEN IF SUCH HOLDER OR OTHER PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAM AGES END OF TERMS AND CONDITIONS How to Apply These Terms to Your New Programs If you develop a new program and you want it to be of the greatest possible use to the public the best way to achieve this is to make it free software which everyone can redistribute and change under these terms To do so attach the following notices to the program It is safest to attach them to the start of each source file to most effectively convey the
33. IVD Cc CR QU LISTED Caution consult accompanying documents Refer to safety related notes in the instructions for use accompanying this product Temperature limitation Store at Use by Manufacturer Batch code Lot number Catalog number In vitro diagnostic medical device This product fulfills the requirements of the European Directive 98 79 EC on in vitro diagnostic medical devices Consult instructions for use The system fulfills the Canadian and U S safety requirements UL LISTED in US accordance with UL 61010A 1 02 and CAN CSA C22 2 No 61010 1 04 Revisions to this document are provided by Roche Diagnostics when necessary No part of this document may be reproduced in any form or by any means without prior written consent Manual version Revision date Changes 05021464001 01 June 2009 New document 05021464001 02 November 2009 Revised for new firmware claims changes and new cleaning recommendations 05021464001 03 May 2010 Revised for CLIA waiver 05021464001 04 August 2010 Revised for CLIA waiver re submission 05021464001 05 May 2012 Revised for new firmware and minor revisions 1 Introduction 11 Before you start n 11 Intended use Important information regarding use If you need help as 2 Genera lO As 12 What can the system do for you cnica 12 Test principle Important safety instructions and additional information
34. Main Menu touch Setup to open the meter settings aM 2 Fromthe Setup Menu touch QC Settings B Control Test 3 From the QC Settings menu touch QC Lockout Setup Menu 09 15 am Screen 04 19 2012 04 19 2012 QC Lockout Operator Lockout E c 04 19 2012 E 72 04 19 2012 09 15 am Number of Levels One Level Two Levels x 04 19 2012 E Meter Setup 4 Select the triggers based on lot and or time for requiring a quality control test You may select from the following options W New Code Yes No applies every time a new test strip lot is used The general intervals are m No E Daily E Weekly m Monthly al Touch the button with the option of choice when changing the test strip lot 6 Touch the button to select the interval of choice Your selection is now highlighted 7 Touch Y to save this setting or touch X to exit this menu without saving any changes 8 For every option except for No you must now indicate the number of levels in which the quality control must be per formed 9 Touch Y to save this setting or touch X to exit this menu without saving any changes The display automatically returns to the previous screen 73 Meter Setup Operator Lockout Optional liquid quality controls can be used to ensure that an operator is performing tests p
35. a handling starting on page 115 5 Touch Y to save this setting or touch X to exit this menu without saving any changes The display automatically returns to the previous screen Beeper The CoaguChek XS Plus meter can display information visually and alert you to special circum stances with a Beeper When the Beeper is enabled the meter beeps when it is switched on it detects a test strip pre heating of the test strip is complete and you need to apply a sample it detects a sample the test is completed and the results are displayed a long beep an error occurs three short beeps an external power adapter is connected when the meter is on We recommend that you keep the Beeper enabled at all times You can also activate a Key Click When a Key Click is enabled the meter clicks briefly every time a button is touched facilitating the input of information 49 Meter Setup B Patient Test UP Control Test eR Review Results 50 A Setup 04 19 2012 ID Setup QC Settings Options rm gt Connection EZ 04 19 2012 09 15 am Screen 09 15 am Beeper Auto Off 04 19 2012 Cu From the Main Menu touch Setup to open the meter settings From the Setup Menu touch Options From the Options menu touch Beeper Beeper 09 15 am High E o qe Key Click Ce Cx 04 19 2
36. adapter Input 100 240 V 50 60 Hz 400 mA Output 7 5 V DC 17A Number of tests per set of batteries Approx 80 tests approx 60 tests per charge cycle when the recharge able battery pack is used Safety class Automatic power off Programmable 1 60 minutes Dimensions 185 x 89 x 42 mm Weight 311 g without batteries Sample material Sample type Capillary whole blood or non anticoagulated venous whole blood Sample size At least 8 uL Interactions Refer to test strip package insert 127 Storage and transport conditions Temperature range 25 C to 70 C 13 F to 158 F Meter without batteries Temperature range 10 C to 50 C 14 F to 122 F Meter with batteries Relative humidity 10 to 85 no condensation At temperatures above 50 C 122 F the batteries could leak and damage the meter At temperatures below 10 C 14 F the batteries do not have enough power to keep the internal clock functioning Further Information Ordering Please contact Roche Diagnostics Customer Service at 1 800 428 4674 Item Description Remarks CoaguChek XS PT Test 2 x 24 test strips 04625315160 CoaguChek XS Pro PT Controls Optional liquid controls for the 04625382160 CoaguChek XS Plus XS Pro systems CoaguChek Capillary Tubes Bulbs Capillary tubes 11621173001 Handheld Battery Pack Rechargeable battery pack 04805640001 Handhel
37. appears first The date and time must be entered before the meter can be used further If at a later time a date adjustment is needed go to the Setup menu then select the menu of choice Both Date and Time display formats are controlled by the Format options you select see page 45 Options shown in the Date and Time menus may vary depending on the chosen formats You can choose between the following display formats W Date Day Month Year e g 01 01 2012 W Date Month Day Year e g 01 01 2012 m Date Year Month Day e g 2012 01 01 W Time 24H or 12H 09 15 am a Patient Test UP Control Test he RI Review Results Setup j 04 19 2012 04 19 2012 09 15 am Screen Options Date Time 09 15 am 04 19 2012 if From the Main Menu touch Setup to open the meter settings From the Setup Menu touch Screen From the Screen menu touch Date Time 41 Meter Setup Date Time 09 15 am Set Date Set Time Format BJ e 04 19 2012 E 42 ver 2012 Month 1 04 19 2012 E From the Date Time menu touch Set Date Touch O and H to set the year then the month then the day Touch Y to save this setting or touch X to exit this menu without saving any changes The display automatically returns to the previous screen If this setup menu appeared auto
38. ar Warranty ROCHE DIAGNOSTICS warrants to the original purchaser only that the meter shall be free from all defects in material and workmanship for a period of one year from the date of purchase Purchaser s sole and exclusive remedy with respect to the CoaguChek XS Plus meter and parts thereof shall be the repair and or replacement of the meter or parts at the option of Roche Diagnostics THE ABOVE WARRANTY IS EXCLUSIVE OF ALL OTHER WARRANTIES AND ROCHE DIAGNOSTICS MAKES NO OTHER WARRANTIES EXPRESS OR IMPLIED INCLUDING WITHOUT LIMITATION THE IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE IN NO EVENT SHALL ROCHE DIAGNOSTICS BE LIABLE TO THE PURCHASER OR ANY OTHER PERSON FOR ANY INCIDENTAL CONSEQUENTIAL INDIRECT SPECIAL OR PUNITIVE DAMAGES ARISING FROM OR IN ANY WAY CONNECTED WITH THE PURCHASE OR USE OF THE METER NO WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE IF ANY IS IMPLIED FROMT HE SALE OF THE COAGUCHEK XS PLUS METER NO WARRANTY EXPRESS OR IMPLLIED IF ANY SHALL EXTEND FOR A LONGER DURATION THAN THE DURATION OF THE EXPRESS WARRANTY STATED ABOVE The foregoing warranty shall not apply to a meter which is damaged by accident or subject to alteration misuse tampering and or abuse including the use of Dispatch products Meters which show damage or misuse will be handled in accordance with Roche Diagnostic s non war ranty service policy The warranty of the repaired replacement meter wi
39. are NOTICE Clean the meter only with the solutions recommended see page 119 Using other solutions may result in incorrect operation and possible system failure Do not let cleaning solution enter the instrument Make sure that the meter is thoroughly dried after cleaning or disinfecting Electromagnetic Interference Do not use the meter near strong electromagnetic fields which could Z N interfere with the proper operation of the meter Touchscreen NOTICE Wi Use only your finger even when wearing gloves or special pens designed for use with touchscreens to touch the screen elements Using pointed or sharp edged objects can damage the touchscreen E Avoid prolonged exposure to direct sunlight Direct sunlight may reduce the life expectancy and functionality of the display 18 Operating conditions To ensure that the meter functions properly please observe the following guidelines E Only use the meter at a room temperature between 15 C and 32 C 59 F and 90 F Only use the meter at a relative humidity between 10 and 85 no condensation a When operating the meter using the power adapter use only a voltage of 100 V to 240 V 10 50 60 Hz E When testing place the meter on a level vibration free surface or hold it so it is roughly horizontal Quality control The meter has a number of built in quality control functions A check of the electronic components and functions every time
40. ass 2 a Di amp D o D D e m af 04 19 2012 ase am The entry is displayed ac 999 Level 1 Code 184 Par PT Op Operator 1 04 18 2012 11 31 am Pass 1 2 INR 1 0 1 4 INR 78 Q 53 99 Q New Control Lot New Strip Lot it 04 19 2012 113 Review Results This page intentionally left blank 114 Extended Functionalities 8 Extended Functionalities Data handling Note Extended data handling functionality is dependent on the capabilities of the particular Data Management System DMS being used and may vary When used in conjunction with the Handheld Base Unit from Roche available separately the CoaguChek XS Plus meter can conveniently connect to a data management system DMS The main advantages of such a connection between meter and DMS may include a Transferring patient lists operator lists and settings from the DMS to the meter In this way the setup for daily work as well as general meter setup can be performed for one or more meters quickly and conveniently E Transferring all stored test results with the corresponding Patient ID Operator ID and comments from the meter to the DMS This transfer of data permits further evaluation or proper archiving according to your needs Through the DMS the system administrator such as the POC coordinator may specify what set tings are to be applied to a set of meters within a site or unit e g hospital
41. by this License they are outside its scope The act of running the Program is not restricted and the output from the Program is covered only if its contents constitute a work based on the Program independent of having been made by running the Program Whether that is true depends on what the Program does 1 You may copy and distribute verbatim copies of the Program s source code as you receive it in any medium provided that you conspicuously and appropriately publish on each copy an appro priate copyright notice and disclaimer of warranty keep intact all the notices that refer to this License and to the absence of any warranty and give any other recipients of the Program a copy of this License along with the Program You may charge a fee for the physical act of transferring a copy and you may at your option offer warranty protection in exchange for a fee 2 You may modify your copy or copies of the Program or any portion of it thus forming a work based on the Program and copy and distribute such modifications or work under the terms of Section 1 above provided that you also meet all of these conditions a You must cause the modified files to carry prominent notices stating that you changed the files and the date of any change b You must cause any work that you distribute or publish that in whole or in part contains or is derived from the Program or any part thereof to be licensed as a whole at no charge to all third parties und
42. cond countdown begins You must apply the drop of blood to the test strip before the countdown ends Otherwise you will receive an error message Testing a Blood Sample Use only a single use lancing device that is approved for use by health A care professionals such as the Accu Chek Safe T Pro or Safe T Pro Plus WARNING lancing devices or the CoaguChek Lancets professional use lancets available only in the United States Follow the manufacturer s instruc tions 11 Now lance the side of a fingertip with the lancing device We recommend obtaining the capillary blood from the side of the fingertip as this causes the least pain Massage the lanced finger gently until a drop of blood is formed Do not press or squeeze the finger Apply the first drop of blood from the finger 12 Apply the blood 8 pL directly from the finger to the semicircular transparent sample application area on top of the test strip E or you can touch the blood drop against the side of the sample application area The test strip draws up the blood by capillary action During this process you must hold the blood drop to the test strip until the flash ing blood drop icon has disappeared and the meter beeps provided the beeper is enabled E you can also apply the blood using the optional CoaguChek capillary tube Apply the blood drop to the test strip within 15 seconds of lancing the fingertip Applying blood after this p
43. cotton swabs buds 1 Remove the test strip guide cover to clean it Use your thumbnail to open the cover of the test strip guide by pressing its front edge upward Move the cover safely away from the meter Then rinse the cover with warm water or wipe it clean using the solu tions recommended above Let the test strip guide cover dry for at least 10 minutes before re attaching it Hold the meter upright with the test strip guide facing down Clean the easily accessible white areas with a moistened cotton swab bud Ensure the swab bud is only damp not wet Wipe away residual moisture and fluids 121 Cleaning and Disinfecting the Meter NOTICE Damage to the instrument E Ensure that no liquid enters the meter If moisture enters the meter it may cause malfunction of the instrument W Donot insert any objects in the test strip guide Doing so may damage the electrical contacts behind the test strip guide On completion of cleaning 3 With the cover off let the test strip guide dry for at least 10 minutes 4 After this time re attach the test strip guide cover to the housing Make sure that the cover is properly closed You will hear it snap into place 122 Troubleshooting 10 Troubleshooting The CoaguChek XS Plus meter continually checks its systems for unexpected and unwanted conditions These may arise for technical reasons defective components or consumables envi ronmental factors or
44. d a enough control solution provided the beeper is enabled The dropper icon disappears and X the test starts 04 19 2012 tu ELEM 550 The result of the liquid quality control test is Op Operant displayed It is automatically saved to memory 04 19 2012 09 Pass 12 INR The acceptable range of results for the liquid 1 0 1 4 INR H 78 Q control is displayed below the current result 53 99 Q along with Pass or Fail m 2 04 19 2012 Ge qe oa ee Ifa quality control test fails an up arrow too Oe Demi high or down arrow too low is displayed and 04 19 2012 09 15 am flashes Fail 0 9 INR 1 0 1 4 INR 120 Note The arrow next to the result refers to the INR result only E 2 If you have selected to display INR and 04 19 2012 Quick or INR and seconds the up or down arrow next to the result refers only to the INR value 106 09 15 al 3 S Acceptable Control Cleaned Meter Doctor Notified New Control Lot e Custom a 04 19 2012 Remove 09 15 am 04 19 2012 p Control Testing and Quality Control 14 If you want to add a comment touch D 15 Select the desired predefined comment s from the pick list if configured or 16 Touch Custom to enter your own custom comment Use the keypad as with login to enter your comment A comment may be up to 20 characters in length 17 Once you have
45. d Base Unit Kit Handheld Base Unit and Operator s 04805658160 Manual Reagents and solutions Supplies are available through Roche Diagnostics Contact your local Roche representative Product limitations Please read the information in the package insert supplied with the test strips for detailed product data and limitations Repairs Please note that repairs and other modifications to the meter may only be performed by persons authorized by Roche 128 Information about software licenses This product incorporates software that is under Icense from General Public License GPL The source code of this software can be requested on a standard data exchange medium from the manufacturer at the following address Roche Diagnostics GmbH Sandhofer Str 116 68305 Mannheim Germany The GPL licensing conditions are printed below in English only for legal reasons GPL Version 2 June 1991 O 1989 1991 Free Software Foundation Inc 51 Franklin Street Suite 330 Boston MA 02001 USA Everyone is permitted to copy and distribute verbatim copies of this license document but changing it is not allowed Preamble The licenses for most software are designed to take away your freedom to share and change it By contrast the GNU General Public License is intended to guarantee your freedom to share and change free software to make sure the software is free for all its users This General Public License applies to most of the Free
46. d close the container again with the stopper Exposure to external influences such as humidity may deteriorate the test strips and may lead to error messages Therefore always close the strip container immediately after removing a test strip 9 Hold the test strip so the lettering with the test name is facing upward 10 Slide the test strip into the test strip guide in the direction indicated by the arrows Slide the test strip in as far as it will go A beep indicates that the meter has detected the test strip provided the beeper is enabled If you use a new test strip lot and have not inserted the code chip yet you must do so now Otherwise you cannot perform a test The meter displays the number of the code chip belonging to the new test strip lot Depending on the setting you may also be required to run a liquid quality control test at this point 89 Testing a Blood Sample 90 09 15 am P ID PIDO1 Smith Henry Op Operator 1 PT Code 184 p 04 19 2012 Em 09 15 am P ID PIDO1 Smith Henry Op Operator 1 PT Code 184 jJ 180 SEC 04 19 2012 The hourglass icon shows that the test strip is warming up When the warming up process is complete a further beep provided the beeper is enabled indicates that you can now apply blood The blood drop icon flashes to indicate that the meter is ready to perform the test and is waiting for blood to be applied A 180 se
47. details see Data handling starting on page 115 85 Testi nn 9 a Blood Sample Performing a test 86 Main Menu A Setup B Patient Test Up Control Test eR Review Results E Main Menu ur Setup P Control Test ES Review Results q Logout Q 09 15 am 04 19 2012 B 1 Checkthe battery level m Ifthe battery icon turns red one bar left there may not be enough power left for another test Wi ifthere are no bars left in the battery icon you cannot perform any more tests Power the meter off using the Qo button In both cases restore power by inserting new batteries recharging the battery pack or using the power adapter 2 Check that the date and time are correct Correct any wrong entries as described in Chapter 4 Meter Setup Setting the date If a lockout Operator or QC Lockout is dis played instead of the Patient Test button you must run a liquid quality control test before you can perform a patient test refer to Chapter 6 Control Testing and Quality Con trol When the meter is in lockout status a test cannot be performed The next steps depend on whether you work with or without patient lists Testing a Blood Sample Without patient list 3 Touch Patient Test ARES 09 15 am 4 If the Patient ID option was chosen as either Optional or Required when the meter was set up see Meter Setup Patient ID y
48. e General Public License Of course the commands you use may be called something other than show w and show c they could even be mouse clicks or menu items whatever suits your pro gram You should also get your employer if you work as a programmer or your school if any to sign a copyright disclaimer for the program if necessary Here is a sample alter the names Yoyo dyne Inc hereby disclaims all copyright interest in the program Gnomovision which makes passes at compilers written by James Hacker Signature of Ty Coon 1 April 1989 Ty Coon President of Vice This product incorporates software that is under license from UCB The UCB licensing conditions are printed below in English only for legal reasons UCB Copyright c 1993 The Regents of the University of California All rights reserved This software was developed by the Computer Systems Engineering group at Lawrence Berkeley Laboratory under DARPA contract BG 91 66 and contributed to Berkeley All advertising materials mentioning features or use of this software must display the following acknowledgement This product includes software developed by the University of California Lawrence Berkeley Laboratory Redistribution and use in source and binary forms with or without modification are permitted provided that the following conditions are met Redistributions of source code must retain the above copyright notice this list of conditions and the foll
49. e previous screen 7 Touch em to return to the Screen menu 46 Options setup Sort Meter Setup Sort refers to the order in which measured and stored results are displayed when you use the Review Results function of the CoaguChek XS Plus meter You can display stored results chronologically by date and time or by person based on the Patient ID If you are working with a DMS and a patient list you can also display the patient list and the stored results sorted by Patient Name e a m 7 ls Patient Test P Control Test ER Review Results ur Setup 04 19 2012 Options ID Setup QC Settings 04 19 2012 09 15 am 15 am Beeper Auto Off Connection B J e 04 19 2012 En From the Main Menu touch Setup to open the meter settings From the Setup Menu touch Options From the Options menu touch Sort 47 Meter Setup 48 09 15 am Sort By Date Time Patient ID Patient Name Cy e 04 19 2012 a The current setting is highlighted You may select from the following sort options 4 By Date Time By Patient ID By Patient Name Touch the button to select the Sort by option of choice Your selection is now highlighted The sort option Patient Name is available only when used together with a patient list Patient lists can only be created with a DMS For more details see Dat
50. e following activation of blood coagulation with human recombinant thromboplastin In simple terms blood works with the chemicals in the test strip to make a small electric current in the test strip that measures blood clotting time 13 Important safety instructions and additional information This section explains how safety related messages and information related to the proper handling of the system are presented in the CoaguChek XS Plus Operator s Manual Read these passages carefully The safety alert symbol alone without a signal word promotes aware ness to hazards which are generic or directs the reader to related safety information These symbols and signal words are used for specific hazards WARNING Indicates a hazardous situation which if not avoided could result in WARNING death or serious injury CAUTION Indicates a hazardous situation which if not avoided could result in CAUTION minor or moderate injury NOTICE NOTICE Indicates a hazardous situation which if not avoided may result in damage to the system Important information that is not safety relevant is presented against a colored background without a symbol Here you will find additional information on correct use of the meter or useful tips 14 Introduction Illustrations in this manual show two different kinds of hands Hand without glove Hand with glove gt A dashed arrow between screen illustrations indicate
51. each test result If you are working with a DMS these comments can be replaced by the comments in the DMS The new wording will then be available for selection from the Comments list in the meter Up to 3 comments can be assigned to each result The default preset comments in the meter are INR result comments Asymptomatic Cleaned Meter Doctor Notified Sick Travel Lab Draw No Action Procedure Error Under Medication Will Repeat Test Changed Dosing QC result comments Acceptable Control Cleaned Meter Doctor Notified New Control Lot New Lot Number New Strip Lot New Strip Kit Lot No Action Procedure Error Proficiency Test Repeat Control Test RN Notified Switched QC Vial Will Repeat Test For more information and technical details please refer to the manual of the Handheld Base Unit and the Technical Note stored on the Handheld Base Unit itself 118 Cleaning and Disinfecting the Meter 9 Cleaning and Disinfecting the Meter W Observe the disinfection guidelines of your institution m Use gloves NOTICE Follow the procedures below to clean disinfect the meter Failure to follow these procedures may cause malfunction of the meter Make sure the meter is powered off Do not spray anything onto the meter and do not immerse it in liquid Ensure that cloth or swab bud is only damp not wet to protect against moisture entering the meter Recommended cleaning disinfecting solutions Use only the fol
52. een inserted E Do not forget to use the test strip code chip that is supplied with each pack of test strips before you perform the first test with these strips We recommend that you leave the code chip in the meter to protect the electrical contacts in the meter from becoming dirty a Each code chip belongs to a particular lot of test strips Only remove the code chip when you are testing with test strips taken from a new pack E Protect the code chip from moisture and equipment that produces magnetic fields Inserting the code chip 1 Remove the old code chip if one is inserted in the meter 81 Testing a Blood Sample 2 Check that the number on the code chip matches the number on the label of the test strip container 3 Slide the new code chip into the code chip slot as shown until you feel it snap into place If the code chip is missing or incorrectly inserted error messages appear in the display refer to the Troubleshooting section of this manual 82 Powering on the meter If the function Operator ID is Testing a Blood Sample 1 Place the meter on a level vibration free surface or hold it in your hand so it is roughly horizontal 2 Power the meter on by pressing the button for approximately 1 second You can also power on the meter directly by inserting a test strip or connecting the power adapter The next steps depend on whether you work with the function Operator ID set to inactive
53. er the terms of this License C If the modified program normally reads commands interactively when run you must cause it when started running for such interactive use in the most ordinary way to print or display an announcement including an appropriate copyright notice and a notice that there is no warranty or else saying that you provide a warranty and that users may redistribute the program under these conditions and telling the user how to view a copy of this License Exception if the Pro gram itself is interactive but does not normally print such an announcement your work based on the Program is not required to print an announcement 130 General Product Specifications UENCIAl r These requirements apply to the modified work as a whole If identifiable sections of that work are not derived from the Program and can be reasonably considered independent and separate works in themselves then this License and its terms do not apply to those sections when you distribute them as separate works But when you distribute the same sections as part of a whole which is a work based on the Program the distribution of the whole must be on the terms of this License whose permissions for other licensees extend to the entire whole and thus to each and every part regardless of who wrote it Thus it is not the intent of this section to claim rights or contest your rights to work written entirely by you rather the intent is to exercise the righ
54. eriod of time may lead to an erroneous result as the coagulation process would already have started 91 Testing a Blood Sample When applied from above the blood must cover the entire sample application area ACA 00 You hear a beep tone when you have applied ide Smith Heny enough blood provided the Beeper is Par PT Code 184 enabled The blood drop symbol disappears and the test starts 04 19 2012 En Do not add more blood Do not touch the test strip until the result is displayed Failure to comply with the above may lead to error messages 92 09 15 am P ID PIDO1 Par PT Smith Henry Op Operator 1 Code 184 QC 04 19 2012 09 15 am P ID PIDO1 Smith Henry Op Operator 1 Par PT Code 184 04 19 2012 09 14 am 2 5 ir 21 Q vi e E 09 15 am P ID PIDO1 Smith Henry Op Operator 1 Par P Code 184 04 19 2012 09 14 am INR gt 8 0 m 04 19 2012 E 04 19 2012 E Testing a Blood Sample The meter performs an automatic quality con trol test on the test strip before it displays the test result QC appears in the display Following a successful outcome of the quality control test a checkmark appears after QC The result is displayed in the unit you chose when setting up the meter It is automatically saved The valid measuring ranges for CoaguChek XS PT test strips are W INR 0 8 8 0
55. es always observe the general precautions and guidelines relating to blood sampling see page 16 Dispose of all test strips used for patient testing in accordance with the disposal policy of your laboratory or practice see page 16 6 Control Testing and Quality Control Control Testing and Quality Control The CoaguChek XS Plus meter has a number of built in quality control functions A check of the electronic components and functions every time the meter is powered on A check of the test strip temperature while a test is in progress A check of the expiration date and lot information on the test strip carried out by the code chip A two level onboard quality control test and patient result determination within a single test chamber Roche offers optional liquid quality controls for the CoaguChek XS Plus system These controls are provided to assist with regulatory compliance requirements as applicable to your facility To perform an optional liquid quality control test using control solutions you need CoaguChek XS Plus meter The test strip code chip supplied with the test strip container you are using A code chip is provided with every test strip package Test strips that came with the code chip mentioned above Bottles of CoaguChek XS Pro PT Controls diluent droppers and the quality control code chip provided You can choose the frequency of liquid quality control tests in the meter setup Refer to the chapte
56. f you selected Custom Range the QC Range screen opens and offers you the following options m Display target value On Off Wi Deviation from target value percentage value See page 69 For the control solutions the target value always comes from the information stored in the code chip If you have chosen Custom Range you can now select an allowed deviation from target value in the range of 0 to 22 5 in the illustration 11 5 Note Percentage deviation from target value is always defined using INR values Even if you have activated Quick in the setup the meter always calculates the deviation using INR values this range is then converted to Quick in a second step As there is no linear correla tion between values expressed as INR and values expressed as Quick if you calcu late the percentage deviation 11 5 in the example using the 9o Quick target value your result may deviate from the result calculated by the meter using the INR target value 5 Touch On the target value will be dis played with a test result or Off the target value will not be displayed Your selec tion is now highlighted 09 15 am QC 999 Level 2 Code 184 Par PT Op Operator 1 04 19 2012 09 15 am 3 0 INR 2 6 3 2 INR 16 Q 16 20 Q vil o 09 15 am QC 999 Level 2 Code 184 Par PT Op Operator 1 04 19 2012 09 15 am 3 0 INR 2 9 2 6 3 2 INR 16 Q 17 16 20 Q m
57. g options No deactivated Weekly Monthly Every 3 Months or Every 6 Months Yearly Touch D and to display the option of choice on the screen Touch the button to select the interval of choice Your selection is now highlighted Touch Y to save this setting or touch X to exit this menu without saving any changes 75 Meter Setup 8 For every option except for No you must Number of Levels now indicate the number of levels in which the quality control must be per formed 9 Touch Y to save this setting or touch X to exit this menu without saving any changes oiaren The display automatically returns to the previous screen 76 Testing a Blood Sample 5 Testing a Blood Sample What you need a CoaguChek XS Plus meter E CoaguChek XS PT Test Strips and matching code chip u When testing with capillary blood Single use lancing device approved for professional use e g the Accu Chek Safe T Pro Plus lancing device or the CoaguChek Lancets CoaguChek Capillary Tubes Bulbs optional Do not use glass capillary tubes or capillary tubes that contain anticoagulants a Cotton ball and alcohol wipe Important notes Always E Close the strip container immediately after removing a test strip a operate the meter at an ambient temperature between 15 C and 32 C 59 F and 90 F E place the meter on a level stable surface table or hold it so it is roughly h
58. ge ai tds hide Du sist E M M M Patel atan Result comfirmation e M 39 Screen IV n TT aora E 83 Symbols e o System Administrator 146 Index T Target valle essre neos nn hiscere EN 71 Temperature iii Ai 19 77 127 Moses X S 13 Test result Patient a rte Dite tpe E eeepc pegas 93 Test result quality control eih 106 Test strip A tetas unm Test strip guide cover BTE B Troubleshooting siii A maa aaabiinl nance U Untitestresull a o oe Nee tees 93 SO ERR 37 V oc M 19 WwW Warranty dit 136 147 Index This page intentionally left blank 148 Notes Notes 149 Notes Notes 150 ACCU CHEK COAGUCHEK and SAFE T PRO are trademarks of Roche Manufactured for and distributed in the U S A by Roche Diagnostics 9115 Hague Road Indianapolis IN 46256 Roche Diagnostics GmbH Sandhofer Strasse 116 68305 Mannheim Germany www roche com www coaguchek com www poc roche com 0 5021464001 05 2012 05 USA
59. ghts to enter certain meter settings and is the only one who can enter and change these settings It is not necessary for Admin identification to be activated to use the CoaguChek XS Plus meter However it might be desired or necessary depending on the regulatory environment and the site of use Operator The Operator ID is assigned to persons who use the meter to run tests If you want to use Operator IDs you have several options You may use Operator IDs to restrict the use of the meter to qualified personnel or a predefined group of users In this case an operator list created externally must be trans ferred to the meter enabling you to select an Operator ID when logging in For more details see Data handling starting on page 115 You may use Operator IDs for informational purposes only in order to assign stored measurement results to the users who performed the test In this case Operator IDs may be entered directly on the meter by keypad Patient The Patient ID is assigned to the person whose test results are recorded You can either block input of a unique Patient ID in this case every test is simply numbered in consecutive order allow a unique Patient ID as optional or require a unique Patient ID for every test Patient lists created externally can also be trans ferred to the meter enabling you to select Patient IDs for a test from these lists For more details see Data handling starting on page 115 Operator ID
60. hanges The display automatically returns to the previous screen 60 9 10 Meter Setup Enter the Admin password again the keypad is automatically displayed again on the screen to confirm the first entry Touch Y to save this entry the Admin password is now set or Touch to exit this menu the Admin password is not set and is therefore still inactive The display automatically returns to the D Setup menu After you exit the Setup menu only an authenticated administra tor may further edit the setup areas as listed before see page 58 61 Meter Setup 09 15 am V2 Control Test Patient Test ur Review Results Setup Menu 09 15 am 04 19 2012 ID Setup 09 15 am SI ES gt 04 19 2012 ID Setup is it 09 15 am 04 19 2012 62 Changing an existing Admin password 1 From the Main Menu touch Setup to open the meter settings 2 From the Setup Menu touch ID Setup 3 Using the keypad displayed on the screen enter the valid Admin password The D Setup menu is displayed The Admin button is highlighted which means an Admin password is active 4 Touch Admin 5 Using the keypad displayed on the screen enter and confirm the new Admin pass word of choice 2 9 a m B Patient Test Control Test ur 0
61. he DMS The presence of the T icon on the Patient Test button indicates a pending OTS request Main Menu 09 15 am ge Control Test N Pat Test OTS 04 19 2012 09 15 am OTS enabled T Observer Login B s Patient Test J Observer 09 15 am 04 19 2012 Pat Test OTS 09 15 am 04 19 2012 OTS enabled T Observer Login ES 04 19 2012 E 140 Observer 1 Touch Patient Test In the Pat Test OTS menu the Patient Test button is grayed out disabled until the observer has logged in 2 Touch Observer Login 3 Wait until the observer list is displayed 4 Select your observer ID by touching the corresponding button Only operators with OTS observer rights are listed in the Observer Login list 5 Enter the optional password 6 After you enter your password touch Y to log in The Pat Test OTS menu is dis played again The Patient Test button is now active 7 Hand the meter to the operator who can now perform the patient test under supervision Pat Test OTS 09 15 am OTS enabled T Observer Login ls Patient Test m A Remove 09 15 am Ne A 1 010 Observer ALAN SMITHEE please log in to proceed Otherwise the OTS test will not be complete 04 19 2012 tu 04 19 2012 tu Observer Login Observer 09 15 am s i OTS
62. ic quality control completed successfully O Elo Sec Results are displayed as a Quick percentage value Results are displayed in seconds INR Results are displayed in INR units Result in the chosen unit of measure is above the measuring range Result in the chosen unit of measure is below the measuring range Quality control Result is above the specified range Quality control Result is below the specified range Battery status When the batteries still have their full charge all segments are lit Individual segments disappear one by one as the batteries become weaker When there is no segment remaining you can no longer perform a test You can however still access the meter s memory Operation with power supply adapter Time between midnight and noon in 12 hour time format Time between noon and midnight in 12 hour time format Room or meter temperature is outside the acceptable range 23 C C x lt Button Icon Meaning The test strip guide cover is open KT y Y Communication is taking place via the infrared interface Reports a status message see Chapter 10 Troubleshooting Reports an error message or a warning see Chapter 10 Troubleshooting 8 2 Power supply The CoaguChek XS Plus meter can be operated with either the power adapter provided four standard type AA alkaline non rechargeable batteries or a special
63. igh lighted white type on a blue background You can select either W INR m INR and seconds W INR and Quick value in CITA 05 4 Touch the button to select the unit of measure of choice Your selection is now Poma highlighted 5 Touch Y to save this setting or touch X to exit this menu without saving any changes X The display automatically returns to the Cu 04 19 2012 previous Screen 38 Result Confirmation Meter Setup In some circumstances it may be useful for operators to confirm the validity of their results Use this setting to prompt operators to confirm the results of every test e 9 a m Ys Patient Test 2 Control Test ur ES Review Results j Setup 04 19 2012 ID Setup QC Settings 04 19 2012 09 15 am Screen Options 09 15 am Result Confirmation Language Selection Date Time B J e 04 19 2012 CO Confirmation 09 15 am Disable 04 19 2012 Cm 1 From the Main Menu touch Setup to open the meter settings From the Setup Menu touch Screen From the Screen menu touch Result Confirmation Touch Enable or Disable Your selection is now highlighted Touch Y to save this setting or touch X to exit this menu without saving any changes The display automatically returns to the previous screen 39 Meter Setup Language Selec
64. ll expire on the date of the original warranty expiration or ninety 90 days after shipment of a replacement system whichever period is longer 136 Appendix 13 Appendix Contact Roche For all questions about the CoaguChek XS Plus system that are not answered in this manual contact your Roche representative or call Technical Service 24 7 365 at 1 800 428 4674 or visit us online at www poc roche com 137 Appendix This page intentionally left blank 138 Supplement for Observed Test Sequence 14 Supplement for Observed Test Sequence Observed Test Sequence OTS Observed Test Sequence options can only be configured using a DMS The availability of electronic configuration options will thus vary according to the data management software utilized by your institution Consult your system administrator The Observed Test Sequence OTS function allows an observer supervisor to assess and record an operator s performance e g for recertification purposes The observer monitors an operator during a test to check that the test is being performed according to the recommended procedures He she then evaluates the performance and passes or fails the operator This assessment is saved together with the test result and any desired comments Note This feature comes disabled on the meter system 139 Supplement for Observed Test Sequence PI Using the OTS function A request for an Observed Test Sequence comes from t
65. login may be configured There are two possible con figurations for an Operator login Operator is activated but there is no list available The Operator can log in via the onscreen keypad The use of the meter is not restricted to a predefined Operator group so Operator IDs are entered via the onscreen keypad and stored with test results for informational purposes only This first configuration is also available without a DMS Meters which are managed by a DMS may receive an Operator list E Operator is activated a list is available and displayed on the login screen The Operator selects the ID from the displayed list If so configured by the Administrator the Operator may also be required to enter a password to log in When working with operator lists The use of the meter is restricted to the operators on this list 116 Patient lists When starting a Patient Test there will be the option of either selecting a Patient ID from a patient list or entering the Patient ID using the onscreen keypad The Patient ID if entered on the DMS comes with an additional identification entry Up to 20 characters can be used and assigned as a second confirmation e g name date of birth There are four possible configurations for a Patient ID input The Patient ID is set to Optional or Required and there is no list available A Patient ID can be entered manually via the onscreen keypad The Patient ID is stored with the test result
66. lowing solutions for cleaning disinfecting the meter housing and test strip guide a 70 ethanol or isopropyl alcohol a 10 sodium hypochlorite solution 1 part bleach to 9 parts de ionized water made fresh every 24 hours NOTICE Do not use any other disinfectants cleaning solutions on the meter housing or test strip guide Use of other disinfectants cleaning solu tions could result in damage to the meter 119 Cleaning and Disinfecting the Meter Cleaning disinfecting the exterior meter housing Use the solutions recommended on page 119 for cleaning disinfecting the meter exterior Apply the solutions for a contact time of gt 1 minute refer to the corresponding product labeling Ensure that the blue test strip guide cover remains tightly closed while cleaning the meter housing 1 With the meter powered off wipe the meter s exterior clean Do not let liquid accumulate near any opening Ensure that no liquid enters the meter 2 With a fresh dry cloth or lint free tissue wipe away residual moisture and fluids after cleaning the housing 3 Allow wiped areas to dry for at least 10 minutes before performing a test 120 Cleaning and Disinfecting the Meter Cleaning disinfecting the test strip guide Use the solutions recommended on page 119 for cleaning disinfecting the test strip guide Apply the solutions for a contact time of gt 1 minute refer to the corresponding product labeling using lint free
67. ly Each time you replace the batteries you need to check and if necessary adjust the date and time 11 Introduction If you need help Information about using the system the screen menus and performing a test can be found in this manual When error messages appear on the screen refer to chapter 10 Troubleshooting For all questions about the CoaguChek XS Plus system that are not answered in this manual contact your Roche representative or Roche Diagnostics Technical Service In order to expedite troubleshooting please have ready your CoaguChek XS Plus meter its serial number this man ual and all related consumables when you call General note The data and information provided in this manual are current as of issue Any substantial changes will be incorporated in the next edition If there is any conflict of information the pack age insert included with the CoaguChek XS PT Test strips shall prevail What can the system do for you The CoaguChek XS Plus system makes coagulation testing easy You only need to insert the code chip power the meter on insert the test strip and apply a small blood sample The blood mixes with the reagents on the test strip and the meter determines when the blood clots The meter displays the results in about one minute After the measurement the meter automatically stores the test result together with date time and patient ID and operator ID if that option is enabled to memory The
68. mary following this B Control Test Options section lets Review Results El ID Setup A Setup QC Settings E 04 19 2012 B 04 19 2012 E 31 Meter Setup Settings summary The diagram below shows all of the setup areas that can be accessed on the meter Setup Screen Result Language Result Units Date Time Options ID Setup QC Settings Operator QC Range ac Lockout 32 Group Subgroup Setting Screen Contrast Meter Setup Values 0 10 5 Result Units INR INR SEC INR Q Result Confirmation Enable Disable Language Selection Dansk Deutsch English Espa ol Francais Italiano Nederlands Norsk Portugu s Suomi Svenska Date Time Date 01 01 2012 Time 12 00 am Date formats DD MM YYYY 01 01 2012 MM DD YYYY 01 01 2012 YYYY MM DD 2012 01 01 Time formats 24 hour time format 24h 12 hour time format 12h with am pm Default settings are labeled with an asterisk 33 Meter Setup Group Subgroup Setting Options Sort Values Date Time Patient ID Patient Name Beeper Beeper Off Low Medium High Key Click Off On Auto Off minutes Off Toss 05 cos WO 15 20 25 30
69. matically after powering the meter on you must touch Y to complete the first date setting Touch e to return to the Screen menu Setting the time Meter Setup When you power on the meter for the first time or after a long period without power this Setup menu appears automatically after you set the date If at a later time a time adjustment is needed go to the Setup menu then select the menu of choice rum e E E m 3 a Patient Test P Control Test I Review Results Setup 04 19 2012 ID Setup QC Settings 04 19 2012 09 15 am 09 15 am Result Urkts Result Confirmation Language Sele Date Time E Te En 04 19 2012 From the Main Menu touch Setup to open the meter settings From the Setup Menu touch Screen From the Screen menu touch Date Time 43 Meter Setup Set Date Date Time 09 15 am 04 19 2012 E 44 09 15 am Set Time Hour 9 M Format NH BJ e Minute 59 v ED 04 19 2012 E From the Date Time menu touch Set Time Touch D and H to set the hours then the minutes Touch Y to save this setting or touch X to exit this menu without saving any changes The display automatically returns to the previous screen If this setup menu appeared automatically after powering the meter on you must touch Y to complete
70. n equus 127 Storage and transport conditions ettet 128 Further Information 128 Ordering 128 Reagents and solutions 128 Prod ct limitatiONS iii ias 128 PRE PAIS nio alii 128 Information about software licenses cocinan 129 12 Warranty 136 13 Appendix 137 Contact ROC titi etiem ptite bo triti re cse nca bal uar tud 137 14 Supplement for Observed Test Sequence 139 Observed Test Sequence OTS estes ttttttttttnnnais 139 Using the OTS Tuc ui 140 Index 143 10 This page intentionally left blank Introduction 1 Introduction Before you start Intended use The CoaguChek XS Plus is intended for use by professional healthcare providers for quantita tive prothrombin time testing for the monitoring of warfarin therapy The system uses fresh capillary or non anticoagulated venous whole blood Important information regarding use Read this operator s manual as well as the package inserts for all relevant consumables before using the system for the first time You must configure the CoaguChek XS Plus meter according to your needs before initial use Refer to chapter 4 Meter Setup Be sure to read the mportant safety instructions and additional information section in this chapter before operating the system Before you use the meter for the first time after you have first inserted the batteries you must set the date and time correctly to allow you to perform measurements proper
71. ntrast Result Units Result Confirmation Language Selection Date Time a Ce 04 19 2012 E 1 From the Main Menu touch Setup to open the meter settings 2 From the Setup Menu touch Screen 3 From the Screen menu touch Contrast If a button is grayed out this means the function is not available 09 15 am Contrast 0 10 00 Cx v 04 19 2012 tu Result Units gt Meter Setup Touch D or H to change the contrast in a range from 0 to 10 Contrast 0 makes the display very dark Contrast 10 makes the display very light Touch Y to save this setting or touch X to exit this menu without saving any changes The display automatically returns to the previous screen Use this setting to select the unit s of measure to be displayed with the results 09 15 am ls B Patient Test Control Test le RI Review Results i Setup 04 19 2012 09 15 am Screen Options ID Setup QC Settings 04 19 2012 E S Contrast Result Units Result Confirmation Language Selection Date Time 09 15 am z 04 19 2012 E 1 2 3 From the Main Menu touch Setup to open the meter settings From the Setup Menu touch Screen From the Screen menu touch Result Units 37 Meter Setup The current unit of measure setting is h
72. onic equipment but meters fall outside the scope of the European Directive 2002 96 EC This is not a require ment for the U S A however Roche is committed to recycling and sus tainability Comply with any laws or ordinances relating to the disposal of sharps and or contaminated products Contact your local health depart ment or other appropriate authorities for proper handling and disposal of used meters used test strips used lancets and used batteries Please consider the following points when disposing of your used testing mate rials Consider recycling of the meters and batteries at an appropriate facility Be aware the meter is potentially hazardous electronics scrap e scrap and should be disposed of accordingly The batteries are potentially haz ardous also and should be disposed of accordingly Disinfect the meter before recycling or disposing 29 CFR 1910 1030 Bloodborne pathogens Directive 2002 96 EC Directive on waste electrical and electronic equipment WEEE Exploding batteries Do not throw used batteries into an open fire They may explode Disposal of used batteries Do not dispose of the batteries with normal domestic waste Dispose of used batteries in an environmentally responsible manner and in accord ance with applicable local regulations and directives Contact your local council local authority or the manufacturer of the used batteries for advice on correct disposal 17 General C
73. or active see Data handling on page 115 inactive MITE 09 15 am 3 Wait until the Main Menu is displayed Ys Patient Test Control Test s Review Results A Setup 04 19 2012 E 83 Testing a Blood Sample If the function Operator ID is active Without operator list 3 You are now prompted to enter an LE 1 Operator ID m Enter the Operator ID using the keypad Touch Y to move to the next screen QESLUL X Xem oe Testing a Blood Sample Crore wem With operator list 3 Wait until the operator list is displayed the corresponding button mn Casey 4 Select the operator of choice by touching ames 04 19 2012 5 Enter the optional password 6 After you enter the password touch 00000 y p Y OZ to log on The Main Menu is displayed and CEP you can start the test B 7 When you touch X the operator pick list is displayed again MITE 99 15am When the tests are completed or another a operator wants to perform additional tests touch Logout to log out this button is availa ble only when the Operator ID is activated The meter returns to the display of the opera tor pick list P Control Test ER Review Results ur C o D 04 19 201 Note Extended data handling functionality is dependent on the capabilities of the particular Data Management System DMS being used and may vary For more
74. orizontal E follow the information on correct handling of test strips in the package insert keep the test strip guide and housing clean See also the chapter entitled Cleaning and Disinfecting the Meter starting on page 119 Protection against infection Z When collecting samples always observe the general precautions and guidelines relating to blood sampling see page 16 Dispose of all test strips used for patient testing in accordance with the disposal policy of your laboratory or practice see page 16 77 Never E Store the meter at extreme temperatures greater than 40 C or 104 F while it is in regular use store the meter in damp or humid conditions without protection remove or insert the code chip while the meter is performing a test use the code chip from a pack of strips other than the one in use touch or remove the test strip during a test Wait more than 15 seconds after a fingerstick before applying the blood fingerstick a patient with wet hands residues of water sweat or alcohol add more blood after the test has begun perform a test with a drop of blood from a previous puncture Accuracy precision of measured results A Failure to comply with the above may lead to inaccurate results An CAUTION incorrect result may lead to an error in diagnosis therefore posing danger to the patient 78 Getting a good capillary blood sample To get a s
75. ou are prompted to enter a Patient ID If Required enter the Patient ID then touch Y to move to the next screen CEE 0009090 Soseoes E pocogoo 000000 W f Optional ignore the prompt and touch to move to the next screen The meter will assign the test a consecutive number WW If neither option was chosen a screen appears that prompts you to insert a test strip Continue with Step 8 87 Testing a Blood Sample With patient list 5 Touch Patient Test GIIA o6 ems 6 Touch D and o to display the entry of De sei en choice Select the patient to be tested a from the list Jones Walther B Hamilton Fran Miller Ted fe Rec Will y 04 19 2012 E 2 Ro a D 3 7 Ifthe patient is not in the list touch New to create a new entry You must now enter a Patient ID CEE BENE 000000 Sceecso REE Note Extended data handling functionality is dependent on the capabilities of the particular Data Management System DMS being used and may vary For more details see Data handling starting on page 115 88 09 15 am P ID PIDO1 M ller David Op Schulz Par PT Ne E 04 19 2012 E 09 15 am P ID PIDOT Smith Henry Op Operator 1 Par PT ul x 04 19 2012 Cum Testing a Blood Sample 8 Thetest strip icon prompts you to insert a test strip Remove a test strip from its con tainer an
76. owing disclaimer Redistributions in binary form must reproduce the above copyright notice this list of conditions and the following disclaimer in the documentation and or other materials provided with the dis tribution All advertising materials mentioning features or use of this software must display the following acknowledgement This product includes software developed by the University of California Berkeley and its contributors 134 General Product Specifications Neither the name of the University nor the names of its contributors may be used to endorse or promote products derived from this software without specific prior written permission THIS SOFTWARE IS PROVIDED BY THE REGENTS AND CONTRIBUTORS AS IS AND ANY EXPRESS OR IMPLIED WARRANTIES INCLUDING BUT NOT LIMITED TO THE IMPLIED WAR RANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE ARE DIS CLAIMED IN NO EVENT SHALL THE REGENTS OR CONTRIBUTORS BE LIABLE FOR ANY DIRECT INDIRECT INCIDENTAL SPECIAL EXEMPLARY OR CONSEQUENTIAL DAMAGES INCLUDING BUT NOT LIMITED TO PROCUREMENT OF SUBSTITUTE GOODS OR SERVICES LOSS OF USE DATA OR PROFITS OR BUSINESS INTERRUPTION HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY WHETHER IN CONTRACT STRICT LIABILITY OR TORT INCLUD ING NEGLIGENCE OR OTHERWISE ARISING IN ANY WAY OUT OF THE USE OF THIS SOFT WARE EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGE 135 12 Warranty CoaguChek XS Plus Meter Limited 1 Ye
77. previous screen 67 QC Settings setup The QC Settings menu contains options for enforcing the performance of liquid quality controls by the operator at specified intervals It also provides the option of customizing the QC Range in accordance with applicable local guidelines QC Range There are two options a Default Range The meter displays the QC Range provided by Roche in the code chip Custom Range The option Custom Range lets the user define their own QC Range within the default range Lockouts QC Lockout and Operator Lockout If the liquid quality control test is not performed correctly or if the result is outside the target value range the meter is locked from further use The Lockout can also be set up selectively for individual operators A liquid quality control test must be completed successfully before the meter is available again for testing either by the operator or in general The option of setting up an Operator Lockout is available only when operator lists are created on a data management system DMS stored in the meter and Operator login is activated These lists are only available in connection with a data management system For more details see Data handling starting on page 115 68 QC Range Meter Setup Liquid Quality control ranges can be customized to comply with local guidelines The QC Range function enables you to narrow the default range 09 15 am Us Patient Test B Control Te
78. r entitled Meter Setup QC quality control Lockout starting on page 72 If the control results in the display are in the specified range this confirms that the liquid control test was performed correctly 97 Control Testing and Quality Control Preparing to run a liquid quality control test Prepare for a liquid quality control test in the same way you would prepare to perform a test with a capillary blood sample The only difference is the use of control solution instead of blood CODE KNAIKOZ B4 luChek XS PT ies 5 184 Have the test strip container at hand If you are using the test strip lot for the first time make sure that the code chip that came with these test strips is at hand Make sure the bottle of freeze dried lyophilized control plasma and the drop per for making the control solution are at hand This bottle should remain refriger ated not frozen until use Make sure that the quality control code chip that came with the control solution is at hand Open the lid of the bottle and remove the rubber cap Hold the dropper with the sealed dropper neck pointing upward then cut off the end of the cap with scissors Do not hold the dropper close to your face To avoid loss of diluent hold the dropper by the stem do not squeeze the bulb of the drop per while cutting the tip 98 Control Testing and Quality Control 7 Apply gentle pressure to the reservoir to transfer the entire contents of
79. r making modifications to it For an executable work complete source code means all the source code for all modules it con tains plus any associated interface definition files plus the scripts used to control compilation and installation of the executable However as a special exception the source code distributed need not include anything that is normally distributed in either source or binary form with the major components compiler kernel and so on of the operating system on which the executable runs unless that component itself accompanies the executable If distribution of executable or object code is made by offering access to copy from a designated place then offering equivalent access to copy the source code from the same place counts as distribution of the source code even though third parties are not compelled to copy the source along with the object code 4 You may not copy modify sublicense or distribute the Program except as expressly provided under this License Any attempt otherwise to copy modify sublicense or distribute the Program is void and will automatically terminate your rights under this License However parties who have received copies or rights from you under this License will not have their licenses termi nated so long as such parties remain in full compliance 131 General Pro 5 You are not required to accept this License since you have not signed it However nothing else grants you permission
80. rechargeable battery pack optional Insert the batteries or the optional rechargeable battery pack even when you use the power adapter This ensures that you will not lose the date and time settings if the power goes out The power adapter also serves as a charger if you use it with the special rechargeable battery pack To save power the CoaguChek XS Plus meter has the option to automatically power itself off based on your setup selections unless a button has been pressed or a new test strip has been inserted The default setting is set to 5 minutes When the meter powers itself off all results obtained up to that point remain in memory and the settings will still be there when you power the meter back on Refer to Auto Offon page 52 24 Main Menu 09 15 am Us Patient Test WP Control Test Review Results A sew NN 04 19 2012 The CoaguChek XS Plus During battery operation the meter always displays the battery power level When replacing the batteries or the rechargeable battery pack you must insert the new batteries or battery pack within ten 10 minutes of removing the old one s to retain the date and time settings If you take longer than this you must re enter the date and time To make sure you do not lose your date and time settings connect the power adapter while you change the batteries or handheld battery pack The meter retains results in memory even when no bat
81. riggered W If you do not work with operator IDs the meter switches to the Main Menu once Auto Off is triggered For information on Operator ID see Operator ID on page 64 52 Meter Setup You may select from the following options Pato or 09 15am m Off meter never powers itself off ae W Time until meter powers itself off 1 10 15 20 25 30 40 50 60 minutes Su 4 Touch ft Or H to select the time of choice in minutes or to switch the feature Cx E 04 19 2012 5 Touch Y to save this setting or touch X to exit this menu without saving any changes The display automatically returns to the previous screen 53 Meter Setup Connection In the Connection menu you can configure the data exchange with external devices The meter can be connected to a computer 1 From the Main Menu touch Setup to open the meter settings 2 From the Setup Menu touch Options B Control Test 3 From the Options menu touch ES Review Results Connection A Setup 2 o a D Us Patient Test 04 19 2012 09 15 am 09 15 am 04 19 2012 Connection 04 19 2012 E 54 Meter Setup Computer The CoaguChek XS Plus meter can connect with a computer or host system running appropriate software that is a DMS must be installed To use this connectivity feature however you need the optional Handheld Base Unit The connection
82. rop erly on the CoaguChek XS Plus meter The Operator Lockout function constrains an operator who has been set up in the list to perform these quality controls on a regular basis 1 From the Main Menu touch Setup to open the meter settings From the Setup Menu touch QC Settings Control Test 3 From the QC Settings menu touch 8 Review Results Operator Lockout If this button is disabled grayed out either no operators have been set up or the Operator ID option has been deacti vated s Patient Test uar a 2 e E 2 3 N Setup Menu 09 15 am Screen 04 19 2012 The option of setting up an Operator Lock outis available only when operator lists are created on the DMS For more details see Data handling starting on page 115 If you are not working with a DMS only the ME 09 15 am QC Lockout is available see QC quality n d o NE control Lockout on page 72 04 19 2012 QC Lockout Operator Lockout B J e 04 19 2012 tu 74 Op Lockout 09 15 am Weekly Monthly Every 3 Months Every 6 Months CX 04 19 2012 m E Weekly Monthly Every 3 Months Every 6 Months e i Yearly _x_ B B 04 19 2012 Meter Setup 4 Select the interval of choice in which the mandatory quality control tests must be performed You may select from the followin
83. s In order to avoid the loss of stored test results you can archive this data using a data management system and the optional Handheld Base Unit see page 115 109 Review Results Viewing test results 1 Place the meter on a level vibration free surface or hold it in your hand so it is roughly horizontal 2 Power the meter on by pressing the O button for approximately 1 second To power the meter off after use press the O button for approximately 1 second 09 15 am 3 Wait until the main menu is displayed MATTE 05 La Patient Test UP Control Test eR Review Results A Setup B 04 19 2012 110 09 15 am B Patient Test Review Results X 04 19 2012 B 09 15 am y Patient Result UP QC Result 04 19 2012 B O f a a e ETC B 4 Touch Review Results 5 Select the type of results you want to view W Display Patient Result memory W Display QC Result memory The following buttons for general use are located in the views described below Menu icon Return to main menu Return icon From the single result display return to the list of results Individual icon List that contains entries for this patient only 111 Review Results Display patient result memory 09 15 am PIDO1 04 18 2012 11 31 am PIDO1 04 17 2012 10 10 am PIDO1 04 16 2012 10 07 am PIDO1
84. s can be selected from a list if available or entered by using the onscreen keypad If passwords were created they must be entered via the onscreen keypad Patient IDs can be selected from a list if available or entered by using the onscreen keypad 56 Operator 2 2 2 3 E jt 04 19 2012 Meter Setup The buttons in the D Setup menu show what the current settings are this is just an example the screen may look different on your meter W The standard display of the Admin button means the function is available but not activated a password for the system administrator supervisor has not been assigned m The standard display of the Operator button means the Operator login is availa ble but not activated W When the Patient button is highlighted that is when it has a blue background this means the function is available and activated either as Optional or Required 57 System Administrator Admin In the default setting the meter is not protected with an Admin password and all setup options are accessible to every user If you set up an Admin password the following setup areas are automatically reserved only for the system administrator supervisor i e the person who knows the password Screen Result Units Date Time Options Connection to a computer ID Setup the entire area QC Lockout QC Range Operator Lockout only available in combination wi
85. s or wards All meters assigned to a specific site and or unit would consequently share the same settings The different operator and patient lists that match a site or unit are then made available on their respective meters Other settings such as QC Lockout and Operator Lockout may easily be set once and distributed to all meters The option of setting up an Operator Lockout is available only when operator lists are created on the DMS stored in the meter and Operator login is activated For more details on Operator login see page 64 for details on Operator Lockout see page 74 Computer Setup option For initial connection to a DMS the ability to communicate within a network has to be set up as follows In the Setup menu the Connection option must be set to Computer see page 54 E The Handheld Base Unit must be configured correctly For details please refer to the manual of the Handheld Base Unit and the Technical Note stored on the Handheld Base Unit itself Place the meter on a Handheld Base Unit that is connected to the network The meter will automatically be recognized by the DMS and may now be assigned to a site and or unit managed by the DMS if your DMS has that functionality a Depending on DMS functionality available the DMS may transfer settings and lists to the meter as well as enable test results to be transferred from the meter to the DMS 115 Operator lists After powering the meter on an Operator
86. s that some screens have been skipped in these illustrations 15 Safety Information Operator qualification Only trained healthcare professionals may operate the CoaguChek XS Plus system Operators must have received comprehensive instruction in the operation quality control and care of the CoaguChek XS Plus system Protection against infection Z N There is a potential risk of infection Healthcare professionals using the WARNING CoaguChek XS Plus system must be aware that any object coming into contact with human blood is a potential source of infection Healthcare professionals must also be aware that any cross contamination is a potential source of infection for patients m Use gloves Wi Use an auto disabling single use lancing device for each patient Dispose of used lancets and needles in a sturdy sharps container with lid Dispose of used test strips according to your institution s infection control policy E Follow all health and safety regulations in force locally 16 Disposal of the System A WARNING A WARNING Any product coming in contact with blood is considered contami nated potentially infectious During normal testing any meter may come in contact with blood Lancing devices may also be considered sharps Disposal of sharps is regulated by law in many jurisdictions The European Union has a requirement for improving waster manage ment practices for certain electr
87. st QC Lockout li Operator Lockout E S A Setup QC Settings S S 04 19 2012 E 04 19 2012 to Q etting 094 cam QC Range 09 15 am QC Range Default Range t 04 19 2012 a P 04 19 2012 From the Main Menu touch Setup to open the meter settings From the Setup Menu touch QC Settings From the QC Settings menu touch QC Range You may select from the following options Default Range Range provided in the code chip is selected and displayed No target value is displayed Custom Range The allowed percentage deviation from target value can now be customized Additionally you can choose between displaying the target value along with a control test result or not displaying the target value with the control test result Touch the button with the setting of choice Your selection is now highlighted If you selected Default Range touch Y to save this setting or touch to exit this menu without saving any changes If you selected Custom Range touch Y to proceed with corresponding settings or touch X to exit this menu without saving any changes The display automatically returns to the previous screen 69 Meter Setup QC Range 09 15 am 2 o a m 3 Display ajo EY Default Range Custom Range Deviation from 9 target value 11 5 9o ee ee e 04 19 2012 E 04 19 2012 70 I
88. t conditions or the patient A comment may be up to 20 charac ters in length You can open the function for adding comments directly in the results screen To add comments If you want to add a comment do not remove the test strip Once the strip is removed the meter automatically returns to Main Menu and a comment can no longer be added 09 15 am P ID PIDO1 Smith Henry Op Operator 1 Par PT Code 184 04 19 2012 09 14 am 2 5 mr 21 Q 04 19 2012 04 19 2012 09 15 am 21 Q Doctor Notified Sick NEW MEDICATION 2 E 04 19 2012 In the Test screen touch D Selectthe desired predefined comment s from the display list if configured or Touch Custom to enter your own custom comment Use the keypad as with login to enter your comment Once you have selected the desired com ment s touch Y to return to the results screen Test results are also saved when the meter is powered off in the results screen or automatically powers off 95 Testing a Blood Sample 96 Remove 09 15 am Nee 1 04 19 2012 After the test result is displayed touch You will be prompted to remove the strip 5 Remove the test strip from the meter 6 Power the meter off 7 Clean the meter if necessary see Chapter 9 Cleaning and Disinfecting the Meter Protection against infection When collecting sampl
89. t to control the distribution of derivative or collective works based on the Program In addition mere aggregation of another work not based on the Program with the Program or with a work based on the Program on a volume of a storage or distribution medium does not bring the other work under the scope of this License 3 You may copy and distribute the Program or a work based on it under Section 2 in object code or executable form under the terms of Sections 1 and 2 above provided that you also do one of the following a Accompany it with the complete corresponding machine readable source code which must be distributed under the terms of Sections 1 and 2 above on a medium customarily used for soft ware interchange or b Accompany it with a written offer valid for at least three years to give any third party for a charge no more than your cost of physically performing source distribution a complete machine readable copy of the corresponding source code to be distributed under the terms of Sections 1 and 2 above on a medium customarily used for software interchange or C Accompany it with the information you received as to the offer to distribute corresponding source code This alternative is allowed only for noncommercial distribution and only if you received the program in object code or executable form with such an offer in accord with Sub section b above The source code for a work means the preferred form of the work fo
90. ter Meter displays an Refer to the package insert for the test strips unexpected result Automatic shutdown The meter powers off after a configurable time without activity e g pressing a key touching the screen to conserve energy Reactivate the meter screen as described in the following Shutdown after time spec W Press the On Off button of the meter ified by system administra tor default is 5 minutes configurable by system administrator 125 Troubleshooting This page intentionally left blank 126 General Product Specifications 11 General Product Specifications Technical data Temperature range 15 C to 32 C 59 F to 90 F Relative humidity 10 to 85 no condensation Maximum altitude 4300 m 14 000 feet Position Place the meter on a level vibration free surface or hold it so it is roughly horizontal Measuring range Q 120 5 SEC 9 6 96 INR 0 8 8 0 Memory 2000 patient and 500 QC results with date and time 60 code chip records Operator lists up to 5000 Operator IDs with corresponding 2nd ID e g Operator Name Patient lists up to 4000 Patient IDs with corresponding 2nd and 3rd Patient IDs e g name date of birth Interface Infrared interface LED IRED Class 1 Battery operation 4x 1 5 V batteries type AA or special rechargeable battery pack for the CoaguChek XS Plus meter Power connection Power supply
91. terface Covered by the semi transparent panel Supports data communication Reset button Use this button to reset the meter in case of software or power up errors 21 Buttons and icons overview The buttons and icons that appear during normal operation are shown here along with their respective meanings Error messages and the description of the icons linked to them are pro vided in a separate chapter See Troubleshooting starting on page 123 Button Icon Meaning Go to Main Menu OK save setting Cancel discard setting 4 m Return to previous menu Reduce increase the value displayed Scroll through lists that are too long to be displayed all at once SI e Inactive button Value cannot be further decreased increased or End of list in this direction is reached List of tests of a specific patient Print after test result or from memory Add a comment Operator must wait until the meter has completed an action Insert test strip Remove test strip s ben ep 180 SEC Apply sample the time left to apply sample is counted down in the display 22 Button Icon Meaning El eo e o m e Apply liquid control QC sample the time left to apply sample is counted down in the display Je Insert the test strip code chip IE Insert the QC code chip Automat
92. teries are inserted All settings other than date and time deleted after 10 minutes without power are retained as well Dispose of used batteries and battery packs in an environmentally A responsible manner in accordance with applicable local regulations and directives See Any product coming in contact with blood is considered contaminated potentially infectious During normal testing any meter may come in contact with blood Lancing devices may also be considered sharps Disposal of sharps is regulated by law in many jurisdictions on page 17 25 Putting the Meter into Operation 3 Putting the Meter into Operation Before using the meter for the first time perform the following steps 1 Insert batteries and or connect the power adapter 2 Set the current date and time 3 Enter the settings of choice language unit of measure user administration if applicable etc Instead of batteries you can use a special rechargeable battery pack Ifyou choose this option order the pack separately from Roche Diagnostics To recharge connect the power adapter to the CoaguChek XS Plus meter or to the optional Handheld Base Unit HBU and dock the meter The meter s battery power level indicator is designed for use with either standard non rechargeable AA batteries or the dedicated Roche handheld battery pack We do not recom mend the use of off the shelf rechargeable batteries in AA format These have lower voltages than standard A
93. th a data management system When you enter an Admin password this password will have to be entered from this point forward before any of the settings above can be changed The Admin password must also be entered before you can delete or change the Admin password itself If you forget the Admin password contact your Roche representative 58 Meter Setup If an Admin password has not been set up yet 1 From the Main Menu touch Setup to open the meter settings 2 From the Setup Menu touch ID Setup Control Test 3 From the D Setup menu touch Admin leR Review Results a Patient Test ar oo 8 a 3 Setup 04 19 2012 09 15 am Options ID Setup QC Settings 09 15 am 04 19 2012 04 19 2012 59 Meter Setup e on 4 Using the keypad displayed on the screen enter the Admin password of choice sco Co Js The password can consist of up to 20 Fe H C s Ce eC characters OODoa Pay close attention to the buttons you press because the characters are not displayed on the screen Asterisks are displayed instead as if entering a pass word on a computer 5 Use 123 to switch to input of numbers Use asc to switch back to input of text 7 Use to backspace and correct a mistake 8 Touch Y to save this setting or touch X to exit this menu without saving any c
94. the first time setting Touch e to return to the Screen menu Setting the display options for date and time Meter Setup Select your preferred format for the date and time display e E a m 5 Ys p ur Patient Test Control Test ER Review Results i 04 19 2012 09 15 am Screen Options ID Setup QC Settings 04 19 2012 Result Urkts Result Confirmation Language Sele Date Time E 4 09 15 am 04 19 2012 tm 1 From the Main Menu touch Setup to open the meter settings 2 From the Setup Menu touch Screen 3 Fromthe Screen menu touch Date Time 45 Meter Setup 4 From the Date Time menu screen touch Set Date Format SELLER 05 Set Time E CIA The current settings are highlighted You can select one of the following display formats Format MM DD YYYY Bee CED W Date DD MM YYYY Day Month Year Crevenn oo_ e g 30 09 2012 Time 21 E m Date MM DD YYYY Month Day Year ae e g 09 30 2012 Cx Cv W Date YYYY MM DD Year Month Day 04 19 2012 E e g 2012 09 30 W Time 24H or 12H 5 Touch the button with the display format of choice for date and time Your selection is now highlighted 6 Touch Y to save this setting or touch X to exit this menu without saving any changes The display automatically returns to th
95. the meter is powered on A check of the test strip temperature while a test is in progress A check of the expiration date and lot information on the test strip based on the code chip data A two level onboard quality control test and patient result determination within a single test chamber Roche Diagnostics has available optional liquid quality controls for the CoaguChek XS Plus system These controls are provided to assist with meeting regulatory compliance requirements as applicable to your facility 19 The CoaguChek XS Plus Meter 2 The CoaguChek XS Plus Meter 20 Overview of the meter elements A Touchscreen Shows test results information icons and results recalled from memory To select an option simply touch the button lightly B On Off button Press and hold this button to power the meter on or off C Test strip guide cover Remove this cover to clean the test strip guide if it has become soiled e g with blood D Test strip guide Insert the test strip here Tab for battery compartment cover Battery compartment cover Covers the battery compartment 4 standard AA alkali manganese batteries or the rechargeable battery pack Charging terminals Used for power supply and or charging the battery pack when the meter is docked in the optional Handheld Base Unit Code chip slot Insert the code chip here Connection socket for power adapter Plug in the power adapter here Infrared in
96. tion Use this setting to select the language for all displays that contain text q De 40 wo a 2 a 2 3 Control Test Patient Test Review Results Setup 04 19 2012 09 15 am Screen Options ID Setup QC Settings 04 19 2012 09 15 am Result Confirm Language Selection Date Time B J e 04 19 2012 Cm Language 09 15 a 3 e Frangais B 04 19 2012 1 From the Main Menu touch Setup to open the meter settings From the Setup Menu touch Screen From the Screen menu touch Language Selection The current language setting is highlighted white type on a blue background You can select either A If the arrow is just an outline Dansk Deutsch English Espa ol Fran ais Italiano Nederlands Norsk Portugu s Suomi Svenska Touch D or 0 to display the language of choice on the screen Do have reached the end of the list in the repective direction 5 6 Touch the button to select the language of choice Your selection is now highlighted Touch Y to save this setting or touch to exit this menu without saving any changes The display automatically returns to the previous screen Setting the date Meter Setup When you power on the meter for the first time or after a long period without power the input field for the date automatically
97. ugh you then the only way you could satisfy both it and this License would be to refrain entirely from distribution of the Program If any portion of this section is held invalid or unenforceable under any particular circumstance the balance of the section is intended to apply and the section as a whole is intended to apply in other circumstances It is not the purpose of this section to induce you to infringe any patents or other property right claims or to contest validity of any such claims this section has the sole purpose of protecting the integrity of the free software distribution system which is implemented by public license practices Many people have made generous contributions to the wide range of software distrib uted through that system in reliance on consistent application of that system it is up to the author donor to decide if he or she is willing to distribute software through any other system and a licensee cannot impose that choice This section is intended to make thoroughly clear what is believed to be a consequence of the rest of this License 8 If the distribution and or use of the Program is restricted in certain countries either by patents or by copyrighted interfaces the original copyright holder who places the Program under this License may add an explicit geographical distribution limitation excluding those countries so that distribution is permitted only in or among countries not thus excluded In such case this
98. uitable drop of blood a Warm the hand Have the patient hold it under his or her arm or use a hand warmer Wash hands with soap and warm water Dry thoroughly E Have the patient let that arm hang down by his or her side before lancing a finger a Massage the finger from its base Use these techniques until the fingertip has increased color E Immediately after lancing massage gently along the side of the finger to obtain a good blood drop without pressing or squeezing too hard Apply the blood drop to the test strip immediately within 15 seconds Optionally you may use a CoaguChek Capillary tube bulb to collect the fingerstick blood sample When washing or disinfecting the patient s finger allow it to dry thor Z N oughly Residues of water or disinfectant on the skin can dilute the drop CAUTION of blood and so produce false results Getting a good result from venous whole blood For sample collection use a standard blood collection device Do not use anti coagulants e g EDTA citrate fluoride oxalate or heparin to collect the blood sample Venous blood samples may be collected from a venous line If venous samples are collected by venipuncture note the following a Use a needle at least 23 G approx 0 65 mm or larger in size m Discard the first four drops of blood collected within the first 10 seconds Then imme diately apply one drop of blood at least 8 pL directly onto the target area of the test strip
99. umber indicates that this code chip is for test strips A capital C in front of the number indicates that it is a con trol solution code chip 103 Control Testing and Quality Control 104 09 15 am QC 999 Code 184 Par PT Op Operator 1 Level 1 Level 2 th 04 19 2012 cn 09 15 am QC 999 Level 1 Code 184 Par PT Op Operator 1 A 04 19 2012 Cu 09 15 am QC 999 Level 1 Code 184 Par PT Op Operator 1 180 SEC Cx 04 19 2012 tu 11 If performing more than one level select the level for this measurement The hourglass icon shows that the test strip is warming up When the warming up process is complete a further beep provided the beeper is enabled indicates that you can now apply the control solution The dropper icon flashes to indicate that the meter is ready to perform the test and is wait ing for the sample to be applied At the same time a 180 second countdown begins You must apply the sample within this time otherwise you will receive an error message Control Testing and Quality Control 12 Using the dropper draw up the dissolved contents of the bottle 13 Apply a single drop of control solution directly from the dropper to the semicircu lar transparent sample application area on top of the test strip Do not add more control solution 105 Control Testing and Quality Control A You hear a beep when you have applie

Download Pdf Manuals

Related Search

Related Contents

ASUS VS197D-P LED display  RIS 1900HE/HW EKO 3.0  Bedienungsanleitung  Manual - Applied Measurement and Control  AUTOMATIKLADER AL 800  External charactor display unit type AGFD  Fujitsu PRIMERGY TX300 S2  Illumine CLI-EMM030932 Instructions / Assembly  

Copyright © All rights reserved. Failed to retrieve file