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CoaguChek XS Pro User Manual

1. 128 Maintenance and Care NOTICE Damage to the instrument m Ensure that no liquid enters the meter If moisture enters the meter it may cause malfunction of the instrument 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 lt gt Cleaning the scanner window The scanner window should be cleaned periodically Use a clean dry cloth to wipe the scanner window 129 Maintenance and Care This page intentionally left blank 130 Troubleshooting 10 Troubleshooting The CoaguChek XS Pro meter continually checks its systems for unexpected and unwanted con ditions These may arise for technical reasons defective components or consumables environ mental factors or 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 i for a status message or X 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 y
2. Time formats 24 hour time format 24h 12 hour time format 12h with am pm Default settings are labelled with an asterisk 35 Meter Setup Group Subgroup Setting Values Options Sort Date Time Patient ID Patient Name Beeper Key Click Off Connection Off Computer Default settings are labelled with an asterisk Meter Setup Group Subgroup Setting Values ID Setup Admin Administrator Blank Off Patient No Optional Required o CO O e Operator Lockout only if the Operator off option is set to Active and an operator list Weekly is available Monthly Every 3 months Every 6 months Yearly Default settings are labelled with an asterisk 37 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 2 Control Test ES A Setup Review Results a a o a o 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 E 38 09 15 am Contrast Re
3. etup Menu 04 19 2012 Options ID Setup I 09 15 am ID Setup 04 19 2012 04 19 2012 67 Meter Setup You may select from the following options E No tests will be assigned numbers automatically Optional Optional automatic numbering or Required list scan manual input E 04 19 2012 E Required list scan 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 XK 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 68 Patient ID 09 15 am Alphanumeric Min Length Max Length JOO 2014 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 ID Your selection is now highlighted Touch D or H to set the number of characters length
4. Temperature limitation Store at sE Use by wo Manufacturer LOT Batch code Lot number REF Catalog number In vitro diagnostic medical device IVD lil Consult instructions for use n The system fulfills the Canadian and U S safety requirements UL LISTED in U accordance with UL 61010A 1 02 and CAN CSA C22 2 No 61010 1 04 LISTED Revision History Manual version Revision date Changes 05548829001 01 2009 09 New document international launch 05914639001 01 2010 04 Update cleaning disinfection minor revisions US launch with document 0 5914639001 01 05914639001 02 2012 05 Update to software version 03 01 new functions minor revisions 05914639001 03 2014 04 Added local area network LAN safety message safety information on battery packs information on barcode symbologies updated information on hidden patient list and patient list validation p 121 122 minor revisions 1 Introduction 11 Before you start n 11 Intended use Important information regarding use If you need help qu 12 General MOLE A a PO A aane 12 What can the system do fOr YOU cinc 12 Test principle Important safety instructions and additional infOrmation ccsssssssscsecssessseeestesseeeeeenetees 14 Safety Informatica 16 Disposal of the ys sscsscisiss sscssicctecsbslevesfaccnttccctetthtuestednssatsasvsaatsanebetananisseestheceeeestect
5. 09 15 am P ID PIDO1 Smith Henry Op Operator 1 Par PT Code 184 04 19 2012 E You hear a beep tone when you have applied enough blood provided the Beeper is enabled The blood drop symbol disappears and the test starts 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 95 Testing a Blood Sample P ID Op Par PIDO1 Smith Henry Operator 1 PT Code 184 acy 04 19 2012 E 09 15 am 09 15 am P ID PIDO1 P ID PIDOT Smith Henry Op Operator 1 Par PI Code 184 04 19 2012 09 14 am 2 5inr 21 Q m 9 Smith Henry Op Operator 1 Par PI INR gt 8 0 vi Code 184 04 19 2012 09 14 am 04 19 2012 04 19 2012 09 15 am P ID PIDOS M ller David Op Schulz Par PT Code 208 04 19 2012 09 14am 1 6 C Asymptomatic Doctor Notified NEW MEDICATION aa 04 19 2012 En 96 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 lt is automatically saved The valid measuring ranges for CoaguChek XS PT test strips are E INR 0 8 8 0
6. 24 R sult cOnfinMatiOn sssaaa n N ai 41 97 Review Results ussssrssnnmeissnam a n a a n 113 123 Dd laa atin dicta daahndtadiinisadiaa 119 S Safety Protection against INfeCtion viii a 16 User CUA NT CALI india dla 16 Scan button 86 91 CNisarccc anta A tea ceseechonscansesfetictossd ai 38 48 Setup Admin PassWord siii obtenida idad 60 65 AO Di ad 54 Display Omaira tdt tada iba 47 ID S tUp ad ais 58 69 A A 42 Operatoria ia 66 o o 49 57 Patient iD A a dale 67 Res l CONTIMAION inn dae 41 Screen O e a A AA O E atl Ane een alanine matin Ur did ren 156 Index STEW ATE COS id 140 nn nn e 49 A n a a NANS 125 Switching on the Meter 85 Symbols EMO MT SS AOS iitrrcata a E A atadatengdeegebaaenittectte 131 System Administrator aia is 60 65 T Target valle eramanen E aE 73 TOPE UE range ic A N aE 22 79 135 Testpanciple ro aio a a e i te 13 Test result Patient iii a a a aaa a ai 96 Test result quality control occ nciciiciccnononin naaa 110 Test strip GO A a e aaa ro A oo n a a e ae Test strip guide cover TOroMboplas nina dd PP Troublesho0 UN dt U Unite tresul iia 96 Units ofimeasurO iii ici 39 V Voltage et mane a a a 22 w Waan reinen E PO a a NS 147 157 Index This page intentionally left blank 158 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 Ro
7. Code 184 Par PT Op Operator 1 04 19 2012 09 15 am Pass 1 2 INR 1 0 1 4 INR 78 Q 53 99 Q m 2 04 19 2012 Erm 09 15 am QC 999 Level 1 Code 184 Par PT Op Operator 1 04 19 2012 09 15 am Fail 0 9 INR 1 0 1 4 INR 110 Q 53 99 Q Gii 2 04 19 2012 E You hear a beep when you have applied enough control solution provided the beeper is enabled The dropper icon disappears and the test starts The result of the liquid quality control test is displayed It is automatically saved to memory The acceptable range of results for the liquid control is displayed below the current result along with Pass or Fail If a quality control test fails an up arrow too high or down arrow too low is displayed and flashes Note The arrow next to the result refers to the INR result only If you have selected to display INR and Quick or INR and seconds the up or down arrow next to the result refers only to the INR value 09 15 al 3 S Acceptable Control Cleaned Meter Doctor Notified New Control Lot Custom a de 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 Selectthe desired predefined comment s from the pick list if configured or 16 Touch Custom to enter your own custom comment
8. 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 Pro meter has the ability to connect to a data management system DMS through the Handheld Base Unit from Roche available separately The CoaguChek XS Pro 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 Strip contains a lyophilized reagent The reactive components of this reagent consist of thromboplastin and a peptide substrate When a sample is applied thrombo plastin activates coagulation which leads to the formation of thrombin At the same time the meter starts to measure the time The enzyme thrombin cleaves the peptide substrate generating an electro
9. Operator s Manual CoaguChek XS Pro Operator s Manual 0 5914639001 03 2014 04 USA The contents of this document including all graphics 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 Engineering Operations department Direct questions or concerns regarding the contents of this document to Roche Diagnostics Engineering Operations Department 9115 Hague Road P O Box 50457 Indianapolis IN 46250 0457 ACCU CHEK COAGUCHEK and SAFE T PRO are trademarks of Roche All other trademarks are the property of their respective owners 2009 2014 Roche Diagnostics US Order Number 05914639001 This document is available electronically at www coaguchek usa com On the packaging and on the identification plate of the instrument you may encounter the following symbols shown here with their meaning A Caution consult accompanying documents Refer to safety related notes in the instructions for use accompanying this product
10. Display patient result memory 09 15 am P ID PIDO1 Par PT Smith Op Operator 1 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 04 15 2012 10 01 am PIDO1 04 14 2012 10 03 am pike Ka 0 Henry Code 184 04 18 2012 11 31 am 2 5inr 21 Q Doctor Notified Sick Travel 04 19 2012 116 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 49 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 Bj 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 H to scroll to the entry of choice on the screen e 2 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
11. 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 US Version of the meter system 149 Supplement for Observed Test Sequence Using the OTS function A request for an Observed Test Sequence comes from the DMS The presence of the f icon on the Patient Test button indicates a pending OTS request Main Menu 09 15 am ge Control Test J Pat Test OTS 04 19 2012 09 15 am OTS enabled 12 Observer Login B a Patient Test J Observer 09 15 am 04 19 2012 Pat Test OTS 09 15 am 04 19 2012 OTS enabled 1S Observer Login ES 04 19 2012 E 150 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 or scan your operator ID which is also your observer ID in this case Only operators with OTS observer rights are listed in the Observer Login list 5 Enter the optional password 6 After you enter your
12. Use the keypad as with login to enter your comment A comment may be up to 20 characters in length 17 Once you have 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 Ifyou are performing a 2 level control you will now be asked to proceed with the second level 19 Power the meter off 20 Removethe quality control code chip from the meter and store it with the controls 21 Clean the meterifthis becomes necessary see Chapter 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 111 Control Testing and Quality Control This page intentionally left blank 112 Review Results 7 Review Results The CoaguChek XS Pro 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 automatica
13. 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 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 73 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 Lockou
14. 7 Use to backspace and correct a mistake 8 Touch Y to save this setting or touch XK to exit this menu without saving any changes The display automatically returns to the previous screen 62 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 60 63 Meter Setup 09 15 am y Patient Test P Control Test n i mm Review Results 09 15 am Setup Menu 04 19 2012 ID Setup 09 15 am 04 19 2012 ID Setup is 09 15 am it 04 19 2012 64 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 ent
15. 86 Main Menu E r Patient Test l ge Control Test ES Review Results Setup i 09 15 am Ys Patient Test 7 Est 04 19 2012 CC Control Testing and Quality Control 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 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 105 Control Testing and Quality Control MICA 09 15am 7 The test strip icon prompts you to insert a i ee test strip Remove a test strip from its con tainer and close the container again with xa the stopper hi 8 Hold the test strip so the lettering with the td test name is facing upward 9 Slide the test strip into the test strip guide in the direction indicated by the arrows 04 19 2012 E 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 alw
16. 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 146 12 Warranty CoaguChek XS Pro Meter Limited 1 Year 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 Pro 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 FIT
17. E Q 120 5 E Sec 9 6 96 Results that are above or below the 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 Testing a Blood Sample Accepting or rejecting a test result EA If this function is enabled you may choose to ip le accept or reject a test result When the result E na is displayed touch 2 5inr E Reject or 2100 m Accept Measurement Result OK 04 19 2012 ED If you reject a result you must enter a com 7 1 009 ment with an explanation A comment is required if you reject a result Please enter a comment 09 15 am ETT If you reject the result this test result is no tg dad longer displayed However the test entry is Par PT Code 184 04 19 2012 09 14 am stored Rejected Will Repeat Test A B 2 E 04 19 2012 97 Testing a Blood Sample Adding comments You can add up to three comments to a test result Comments can provide for example addi tional information about the test conditions or
18. E e qe Key Click O Cx 04 19 2012 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 53 Meter Setup Auto Off You can set up your CoaguChek XS Pro 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 2 g a 2 3 From the Main Menu touch Setup to open the meter settings Ye Patient Test 2 From the Setup Menu touch Options 2 Control Test wm From the Options menu touch Auto Off Review Results Setup 04 19 2012 09 15 am Options ID Setup QC Settings 04 19 2012 09 15 am Beeper Auto Off Connection 5 Te ED 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 E If you work with operator IDs the meter switche
19. En 04 19 2012 The current unit of measure setting is high lighted white type on a blue background You can select either m INR m INR and seconds E INR and Quick value in 4 Touch the button to select the unit of measure 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 display automatically returns to the previous screen 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 ka a 2 Ys Patient Test 2 Control Test OA ES Review Results i Setup 04 19 2012 09 15 am Screen Options ID Setup QC Settings 04 19 2012 Result Confirmation Date Time 09 15 am Language Selection B J e 04 19 2012 E Confirmation 09 15 am Disable 3 04 19 2012 es 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 41 Meter Setup Langua
20. Unit itself 123 Extended Functionalities This page intentionally left blank 124 9 Maintenance and Care Maintenance and Care Conditions for storage and shipping Storage a Store the system and test strips in the same environment in which they are used E Do not store the meter in direct sunlight or under extreme temperature conditions E Observe the limits for temperature and humidity when storing and using the meter see Chapter 11 Shipping Observe the following safety information when shipping the meter and Z battery pack Failure to do so may result in injury to persons or damage to the meter or battery pack E If the meter has to be shipped or transported over long distances always remove the bat tery pack from the meter This eliminates the possibility of the battery pack overheating due to a short circuit It also prevents deep discharge and other damage to the battery pack or meter E Only ship undamaged battery packs Damaged battery packs must be disposed of locally See page 19 for the risks associated with damaged battery packs and disposal informa tion E Package the battery pack for shipping so that it cannot move around in the packaging Also observe any other applicable national regulations E When shipping via third parties e g by air or parcel service work with the carrier to check whether specific requirements need to be met in relation to the lithium ion battery packs on the basi
21. by inserting a test strip or connecting the power adapter 3 Topowerthe meter off after use press the button for approximately 1 second 31 Putting the Meter into Operation Checking the software version 32 MA CoaguChek XS Pro 03 01 00 After displaying the Roche logo the meter briefly displays the nit for initialization 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 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 e9 Y for OK Other screen elements e g Menu titles are written in talics 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 43 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
22. display automatically returns to the previous screen 75 Meter Setup Operator Lockout Optional liquid quality controls can be used to ensure that an operator is performing tests prop erly on the CoaguChek XS Pro 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 g Patient Test om oo o e a o 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 119 If you are not working with a DMS only the E 9 15 0m QC Lockout is available see QC quality OC Range control Lockout on page 74 04 19 2012 QC Lockout Operator Lockout 2 e 04 19 2012 E 76 Op Lockout 09 15 am Weekly Monthly Every 3 Months Every 6 Months Cx 04 19 2012 i E p Weekly Monthly Every 3 Months Every 6 Months i Yearly _x
23. dob anaes ae 86 L ies 94 LAU ii baad Gina Kuh ciate ies 42 O a dines 24 Lockout e no A p na 76 Quality Control 74 88 Ogre le epale asdu EAN 87 154 Index M Mains voltage sssaaa R ON RNE 22 135 Measurement PErOrMIN Gee a ladies ata aia 88 99 Pre Palin iii 82 UE AAA o A ites iuntiaantiheaiat 96 135 Memory DON a teatoss nanstestrtictattaedactictogtugtesttettedannal fieetnarsinc eaten teat 115 Patient Result cia 116 Quality Control cuisine 117 Meter OVNI Wicca oi 23 0 Observed Test Sequence OTS ss sscccsccssssssseseecesssnseeesseeeesnmtseeeeeeeennmussteceereesanusseneeesecesnnaseneeeeseeta 149 151 Operating COMTI OTS caci n di eiii 22 135 Operator Lockout Logout senssa S A aad onan hanna RE Password Operator ID Operator list OPUONS misanan ias OH AI Gh PPP PA o al Ea Overview Meter elements urraca ainia an 23 SUP ata 34 37 P A AAA 2 A 87 Pati nt Di aa a a a R 67 PA a a A 90 121 Power adapter di 27 POWYS OM O 85 Power supply Charging terminals Handheld Base Unit 0 ssssssssccsssssssssseessseecssnnssesseeecesnnsttesseseesennteeseeeesesnness 24 PFOGUCE SPeCITICATIONS vir ti 135 Putting the meter into operation u nniciiicicnonn enana 29 31 155 Index Q LOA Ip Lo EPA e 71 A PP eedis eee ae 70 75 Quality Control Lockout Memo Viseras ted it dei atada abha ib aician Preparing A e a R Relative NUMidity a R ad a S 22 135 Reset button
24. from the meter prior to replacing the battery pack to prevent loss of data see Chapter 8 When storing or disposing of the battery pack use the manufacturer s original packaging 19 Electromagnetic Interference A Do not use the meter near strong electromagnetic fields which could interfere with the proper operation of the meter Touchscreen NOTICE E 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 20 Local Area Network protection from unauthorized access If this product is connected to a local area network this network must be protected against unauthorized access In particular it must not be linked directly to any other network or the Inter net Customers are responsible for the security of their local area network especially in protect ing it against malicious software and attacks This protection might include measures such as a firewall to separate the device from uncontrolled networks as well as measures that ensure that the connected network is free of malicious code Wired network connection If the Handheld Base Unit from Roche is used to connect this meter to a local area network the Handheld Base Unit must be protected again
25. is available but set to hidden The Operator can login via a barcode scan 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 120 Patient lists When starting a Patient Test there will be the option of either selecting a Patient ID from a patient list entering the Patient ID using the onscreen keypad or if available of scanning the barcode with the Patient ID 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 a 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 or read in via a barcode scan The Patient ID is stored with the test result a 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 scan a Patient ID using the barcode scanner create a new patient entry by touching New Instead of an ID a consecutive number will be assigned to this result a The Patient ID is set to Optional or Required and there is a list available The list of Patient IDs is always shown when star
26. 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 previous screen 69 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 E 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 119 70 QC Range Meter Setup Liquid Quality control ranges can be cust
27. password 6 After you enter the password touch 00000 y p Y OZ to log on The Main Menu is displayed and BiG you can start the test 7 When you touch X the operator pick list is displayed again T 99 15am When the tests are completed or another 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 Control Test ER Review Results SA Gi town D 04 19 201 xz 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 119 87 Testing a Blood Sample Performing a test 88 Main Menu A Setup Ys Patient Test Uy Control Test 8 Review Results E Main Menu OO Setup Control Test ES Review Results q Logout 09 15 am 04 19 2012 B 1 Check the battery level If the battery icon turns red one bar left there may not be enough power left for another test m If there are no bars left in the battery icon you cannot perform any more tests Power the meter off using the button In both cases restore power by inserting new batteries recharging the battery pack or using the power adapter 2 Check tha
28. 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 1 Observer Login Ys Patient Test m A Remove 09 15 am Neo please log in to proceed Otherwise the OTS test will not be complete 04 19 2012 a 04 19 2012 E Observer Login Observer 09 15 am OTS passed A 1 010 Pass Fail Observer ALAN SMITHEE Measurement Result OK 5 i Reject Comment gt Accept 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 151 Supplement for Observed Test Sequence This page intentionally left blank 152 Index Index A Adapter POWer SUP o 27 Admin PASS WO sii iii 60 65 Applyin
29. 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 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 143 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 conditio
30. 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 136 Operator and patient ID barcode masks Barcode mask character Definition A Z 0 9 Dollar Asterisk Tilde Plus Caret If not preceded by the Caret the scan data character must be the same as the mask character This character is not saved as part of the ID If the characters are not the same the scan data is not a valid ID The scan data character in this position is kept as part of the ID The scan data character in this position is not kept as part of the ID The scan data character in this position must be a number 0 9 and it is not kept as part of the ID If the scan data character is not a number the scan data is not a valid ID The scan data character in this position must be an alpha character A Z and it is not kept as part of the ID If the scan data character is not an alpha character the scan data is not a valid ID This mask character denotes that the scan data character must be equal to the next character in the barcode mask after the and that the scan data character is kept as part of the ID If the scan data character is not equal to the mask character following the the barcode reading is invalid as an ID 137 Example of barcode sym
31. 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 CCA 09 15am 1 In the Test screen touch D P ID PIDO1 4 og reel 2 Select the desired predefined comment s ry eee from the display list if configured or 2 5ine 3 Touch Custom to enter your own custom 210 comment Use the keypad as with login to enter your comment 4 Once you have selected the desired com ment s touch Y to return to the results screen m 04 19 2012 04 19 2012 09 15 am Smith Henry Operator 1 eT Code 184 0449 2012 09 14 am 2 5inr 2 1 Q Doctor Notified Sick NEW MEDICATION 2 E 04 19 2012 Test results are also saved when the meter is powered off in the results screen or automatically powers off 98 Testing a Blood Sample After the test result is displayed touch 8 You will be prompted to remove the strip 5 Remove the test strip from the meter 6 Power the meter off y hn 7 Clean the meter if necessary see m Chapter Cleaning and Disinfecting the Meter 04 19 2012 E Protection against infection When collecting samples always observe th
32. 2 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 batteries 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 28 Putting the Meter into Operation 3 Putting the Meter into Operation Before using the meter for the first time perform the following steps 1 2 3 Insert batteries and or connect the power adapter Set the current date and time Enter the settings of choice language unit of measure user administration if applicable etc Ins
33. 56 ID setup System Administrator Admin A Operator ID naenin aaa a a Patient UD iiin nha aiir OG Settings Setup idas OC IRAN GG CARPA nn EA QC quality control Lockout Operator LOCKOUE iii 5 Testing a Blood Sample Important NOS cccnnnnicccnnnone Getting a good capillary blood sample i Getting a good result from venous whole blood occ 81 Preparing tO Tes diia ii inn 82 Teststrip coderCA Petardos aneii 83 Inserting the code Cp a a 83 Powering on the meter 85 Performing a Stones 88 Accepting or rejecting a test result 97 Adding comments ici Aa 98 6 Control Testing and Quality Control 101 Preparing to run a liquid quality control test 102 Performing a liquid quality control teSt essecsssssssssssessssecsssnesessececsssnsteceeseesennteeseeeeseenaess 104 7 Review Results 113 Viewingtest results viii aian aan A 114 Display patient result MEMOTY sssscscccccsssessessseescssnteesseeecesneteesseeeesssnnttesseeeceenntteeseeeeeee 116 Display QC quality control result MEMOTY sseesesssesceceeeeeeeeeeeseeseesesssnnnnsnsamueeess 117 8 Extended Functionalities 119 Data dl 0 A hae 119 Computer SEtUp OPlIO lisina rs 119 Operator lists ii oe 120 Patient listS 121 Patient list validation 122 Barcode SCaMMTnnnnnnnn canciones a 122 Stored test results and COMMENTS sseeesesssccseeeeeseeeesssssssssnssssseseesseseeceeeeeeeeeeeseeeeseseneey 123 9 Maintenance and C
34. Button Icon Meaning Apply liquid control QC sample the time left to apply sample is counted down in the display Insert the test strip code chip Insert the QC code chip Automatic quality control completed successfully Results are displayed as a Quick percentage value Results are displayed in seconds 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 26 Button Icon Meaning The test strip guide cover is open O s Y Communication is taking place via the infrared interface Reports a status message see Chapter 10 Troubleshooting Reports an error message or a waming see Chapter 10 Troubleshooting 5 2 Power supp
35. 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 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 144 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 S
36. MS For more details see Data handling starting on page 119 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 Pro 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 a barcode is scanned 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 51 Meter Setup Us Patient Test UP Control Test Fass Review Results 52 A Setup 04 19 2012 ID Setup QC Settings Options gt Connection EZ 04 19 2012 09 15 am Screen 09 15 am Beeper Auto Off 04 19 2012 E 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
37. NESS FOR A PARTICULAR PURPOSE IF ANY IS IMPLIED FROM THE SALE OF THE COAGUCHEK XS PRO METER 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 will expire on the date of the original warranty expiration or ninety 90 days after shipment of a replacement system whichever period is longer 147 Appendix 13 Appendix Contact Roche For all questions about the CoaguChek XS Pro 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 coaguchekusa com 148 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
38. Pass 2 2 2 oF a Di 8 o E 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 Pass 2 a Di amp D Di D D 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 JU 04 19 2012 117 Review Results This page intentionally left blank 118 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 Pro 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 coord
39. Quality control The meter has a number of built in quality control functions E A check of the electronic components and functions every time the meter is powered on E A check of the test strip temperature while a test is in progress E A check of the expiration date and lot information on the test strip based on the code chip data E 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 Pro system These controls are provided to assist with meeting regulatory compliance requirements as applicable to your facility 22 The CoaguChek XS Pro Meter 2 The CoaguChek XS Pro Meter 23 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 E Barcode scanner Laser The integrated barcode scanner can read operator and patient IDs into the meter F Tab for battery compartment cover 24 Battery compartment cover Covers the battery compartment 4 standard AA alkali manganese batteries or the rechargeable battery pack C
40. _ 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 following options No deactivated Weekly Monthly Every 3 Months or Every 6 Months Yearly Touch O and O 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 77 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 owieremg The display automatically returns to the previous screen 78 Testing a Blood Sample 5 Testing a Blood Sample What you need a CoaguChek XS Pro meter a CoaguChek XS PT Test Strips and matching code chip E 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 a Close the strip container immediately after removing a test s
41. 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 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 o
42. ad Indianapolis IN 46256 Roche Diagnostics GmbH Sandhofer Strasse 116 68305 Mannheim Germany www roche com www coaguchek usa com 0 5914639001 03 2014 04 USA
43. administra tor default is 5 minutes configurable by system administrator 133 Troubleshooting This page intentionally left blank 134 11 General Product Specifications Technical data Product Specifications 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 Barcode scanner Laser Class 1 according to EN 60825 1 2007 see page 138 Battery operation 4x 1 5 V batteries type AA or special rechargeable battery pack for the CoaguChek XS Pro meter or CoaguChek XS Plus meter Power connection Power supply adapter Input 100 240 V 50 60 Hz 350 150 mA Output 7 5 V DC 1 7 A 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 minut
44. 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 through 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
45. are 125 Conditions for storage and SHIPPING sssssssssssssseesseeseeeeeeeseeseesesesssssssnsnssnuusstenseeeeeees 125 SOC A iia 125 PIO sisaria dinaa e a i a a eG 125 Cleaning and Disinfecting the Meter 126 Recommended cleaning disinfecting solutions Cleaning disinfecting the exterior meter housing 127 Cleaning disinfecting the test strip guide esseccseeeseeeseeeeeseesnssssssnsnsunssseeeetees 128 Cleaning the scanner WiIndOW ssssssssssssssssssssssssseeeessesseeseseeseesesssssssssssnsanuamssesseseesees 129 10 Troubleshooting 131 Additional information on error E 406 onnanicciccccocacianinnannnonnonmonnnennrnnnenernes 132 Errors and unusual behavior without error Messages cicccccccacacannanaananreennsnmnenccnns 133 11 General Product Specifications 135 Technical ata ii 135 Sample Materia 135 Storage and transport conditions Further Information Ordering eccecaanaanaaninnannnn s 136 Reagents and Solutions acciona i 136 Pr d t LIMITATIONS cta canica 136 Repairs nic aa ao 136 Operator and patient ID barcode MaskS sssssssssssesscssesseseeseeeessesssssssssssnssnusmseseeesees 137 Example of barcode symbologies u ssssssssssssssssssssssisssseeseeeeesseeseesensessnsnnnsnnunmasesteetsetsees 138 Information about software licenses cnc 140 12 Warranty 147 13 Appendix 148 Contact ROCES iaa 148 14 Supplement for Observed Test Sequence 149 Observed Test S
46. ays close the container immediately after removing a test strip 106 Op Operator 1 184 ul imi ED 04 19 2012 p 09 15 am New Code Qc 070 Qc 060 Qc 050 QC 048 _x_ 04 19 2012 ith B 09 15 am Code 184 Par PT Op Operator 1 iat Lx 04 19 2012 E 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 If you 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 l
47. be transferred from the meter to the DMS 119 Extended Functionalities Operator lists After powering the meter on an Operator login may be configured There are four possible con figurations for an Operator login E Operator is activated but there is no list available The Operator can either log in via the onscreen keypad or a barcode scan The use of the meter is not restricted to a predefined Operator group so Operator IDs are entered via the onscreen keypad or read from the barcode and stored with test results for informational purposes only This first configuration is also available without a DMS E Operator is activated there is no list available and the List feature is set to hidden only possible with a DMS Setting the List feature to hidden with the DMS automatically blocks the display of the meter s onscreen keypad as well The Operator can only log in via a barcode scan as there is no onscreen keypad The use of the meter is not restricted to a predefined Operator group so Operator IDs are read from the barcode and stored with test results for informational purposes only 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 E Operator is activated a list
48. bologies When creating patient or operator barcodes always adhere to the appli A cable international IEC ISO standards for the respective barcode sym bology In particular ensure that barcode size and print quality as defined in ISO IEC 15421 are adequate Inadequate print size and or quality may lead to erroneous decoding EAN 13 barcodes although widely used in retail are less recommendable for patient operator barcodes If used they demand the very highest quality standards of barcode creation and reproduction The barcode samples shown here are for illustration purposes only If printed out they can be used to check the barcode scanner However they are not meant to be used as a reference for size or resolution of real patient or operator ID barcodes Always refer to the relevant standard ISO IEC 15421 for size and resolution requirements when creating patient or operator barcodes 138 General Product S ications 1234567890 A aaa 1234567890 we mn ABC123 1234567890 a IS 111122231334448 1234567890 139 Information about software licenses This product incorporates software modules developed under license from General Public License GPL The source code of this software can be requested on a standard data exchange medium from the following address Roche Diagnostics GmbH Sandhofer Str 116 68305 Mannheim Germany The GPL licensing cond
49. 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 1 Touch Setup to open the meter settings SESE 09 15 am 2 GEERT 09 15 am ae Select the group of settings of choice see creen the Settings summary following this pe Control Test Options section he Review Results El ID Setup A Setup QC Settings E 04 19 2012 E 04 19 2012 B 33 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 34 Screen Contrast 0 1065 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
50. chemical signal Depending on the time elapsed when it first appears this signal is then converted by means of an algorithm into customary coagulation units INR Quick sec onds and the result is displayed 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 Pro Operator s Manual Read these passages carefully The safety alert symbol alone without a signal word promotes aware Z 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 AN 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 a exe A Hand with glove A dashed arrow between screen illustrations indica
51. control tests in the meter setup Refer to the chapter entitled Meter Setup QC quality control Lockout starting on page 74 If the control results in the display are in the specified range this confirms that the liquid control test was performed correctly 101 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 Have the test strip container at hand 2 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 CODE ji ODEs TT 3 Make sure the bottle of freeze dried 18 lyophilized control plasma and the drop CoaguChek XS PLE 5_18 per for making the control solution are at hand This bottle should remain refriger ated not frozen until use 4 Make sure that the quality control code chip that came with the control solution is at hand 5 Open the lid of the bottle and remove the rubber cap 6 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 102 Control Testing and Quality Control 7 Apply ge
52. d 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 D set to inactive or active see Data handling on page 119 inactive SET 09 15 am 3 Wait until the Main Menu is displayed Ys Patient Test Ye Control Test s Review Results A Setup 04 19 2012 B 85 Testing a Blood Sample If the function Operator ID is active Without operator list 3 You are now prompted to enter an Operator ID E Enter the Operator ID using the keypad Touch Y to move to the next screen E Alternatively the Operator ID can also be entered via the built in barcode scanner Touch Scan and scan the operator bar code from a distance of approx 10 cm 4 inches The meter beeps once the barcode has been read successfully The barcode information appears in the operator ID field The scanner turns off after 10 seconds if a barcode is not scanned 0000009 000000 10000009 000000 000000 9 A A barcode does not need to be present for the laser scanner to become active Do not stare directly into the laser beam WARNING 86 Testing a Blood Sample Operator 09 15 am With operator list 3 Wait until the operator list is displayed the corresponding button mn Casey 4 Select the operator of choice by touching amen 5 Enter the optional
53. d from the list 7 Ifthe patient is not in the list touch New to create a new entry You must now enter a Patient ID 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 119 90 Testing a Blood Sample Alternatively the Patient ID can also be entered via the built in barcode scanner Touch Scan and scan the patient barcode from a distance of approx 10 cm 4 inches The meter beeps once the barcode has been read successfully The barcode information appears in the patient ID field The scanner turns off after 10 seconds if a barcode is not scanned A A barcode does not need to be present for the laser scanner to become active Do not stare directly at the laser beam WARNING 91 Testing a Blood Sample 09 15 am P ID PIDO1 Miiller David Op Schulz Par PT Ney 4 Itt pu Cx 04 19 2012 E 09 15 am P ID PIDO1 Smith Henry Op Operator 1 Par PT 184 ul x 04 19 2012 E 8 The test strip icon prompts you to insert a test strip Remove a test strip from its con tainer and 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 imme
54. d Base Unit The connection is established in two steps A The meter connects to the Handheld Base Unit via infrared a 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 A 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 METIA 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 of the particular Data Management System DMS being used and may vary For more information on DMS please contact your Roche representative 57 N r 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 Admi
55. diately after removing a test strip 9 10 Hold the test strip so the lettering with the test name is facing upward 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 09 15 am P ID PIDOT Smith Henry Op Operator 1 PT Code 184 Da 04 19 2012 E P ID PIDO1 Smith Henry Op Operator 1 Par PT Code 184 d 180 SEC 04 19 2012 E Testing a Blood Sample 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 second countdown begins You must apply the drop of blood to the test strip before the countdown ends Otherwise you will receive an error message 93 Testing a Blood Sample 94 A WARNING Use only a single use
56. e 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 99 Testing a Blood Sample This page intentionally left blank 100 6 Control Testing and Quality Control Control Testing and Quality Control The CoaguChek XS Pro 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 Pro 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 Pro 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
57. ect 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 142 5 You are not required to accept this License since you have not signed it However nothing else grants you permission 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 lf as a consequence of a court judgment or allegation of patent infringement or for
58. ependent 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 right 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
59. equence OTS ssccsssssssssssssssssesssstssseseesesnnatsseeeescensnetsseeeeseennneeseeeseeeetee 149 Using the OTS Tuc ida 150 Index 153 10 This page intentionally left blank 1 Introduction Before you start Intended use The CoaguChek XS Pro system CoaguChek XS Pro meter and CoaguChek XS PT Test strips quantitatively determines prothrombin time PT using capillary blood or whole blood from a vein nonanticoagulated venous whole blood It is indicated for use by healthcare professionals The system is ideally suited to monitor coagulation values in people who are taking oral anti coagulation medication vitamin K antagonists VKAs 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 Pro meter according to your needs before initial use Refer to chapter 4 Meter Setup Be sure to read the mportant safety instructions and additional informa tion 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 properly 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 menu
60. er and confirm the new Admin pass word of choice 2 2 a D Ys Patient Test Control Test O 09 15 am Screen ID Setup QC Settings Admin 09 15 am 04 19 2012 09 15 am Operator Mp E 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 65 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 119 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 acti
61. er no circumstances however 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 E 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 132 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 MH Wait 10 seconds and try powering on the unit again power on M Check that the meter has power If you are using the external power adapter is it connected properly to the meter Or Place the meter in the Handheld Base Unit Or If you are using the Handheld Battery Pack is it properly installed in the meter 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 Press the On Off button of the meter ified by system
62. erior 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 127 Maintenance and Care Cleaning disinfecting the test strip guide Use the solutions recommended on page 126 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 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 2 Hold the meter upright with the test strip guide facing down m Clean the easily accessible white areas with a moistened cotton swab bud m Ensure the swab bud is only damp not wet Wipe away residual moisture and fluids
63. es Dimensions 231 x 97 x 43 mm Weight 350 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 135 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 Reference number CoaguChek XS PT Test 2 x 24 test strips 04625315160 CoaguChek XS Pro PT Controls Optional liquid controls for the 04625382160 CoaguChek XS Pro XS Plus systems CoaguChek Capillary Tubes Bulbs Capillary tubes 11621173001 Handheld Battery Pack Rechargeable battery pack 04805640001 Handheld 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
64. ethtevwstsisasts 17 General Canes ii ds 18 Laser SC apena 18 Batteries battery Pak a 18 Battery pack saciar iones 19 Electromagnetic Interference coccion 20 MOU GHSCREGN it 20 Local Area Network protection from Unauthorized ACCESS cnica 21 Wired Network Connection sssssssssssseeeseeseeceeeeeeeeeeceesssssnssnnsasuumussseetseeseeeeeeeeteseeseseeted 21 Operating CONAIIONS aviaci n oi 22 Quality controlxiarii n A 22 2 The CoaguChek XS Pro Meter 23 Overview of the meter elemeniS once 24 Buttons ANd CONS OVEIVIEW cnnnciciiiini nn rr 25 POWer SUP Dl Vestine ina notidoaanena ist aaaieden 27 3 Putting the Meter into Operation 29 Inserting the batteries cnonnunacinnonnnnnnno en naaa 30 Powering the meter on and Off nn cciccccicicnin 31 Checking the software VerSiON ssssssssssssssssseussessessseeesseeseesessesssssnssnssnusnmuusieeseeseeeeeeet 32 4 Meter Setup 33 Note on presentation of screen elements in this MaMUAI sscccssccsseeeesseeeseeeeetees 33 Settings SUMIMALY oaeeesescsssssssessesssssssnsssnssnussesteseeeeseeeeeeeeeeeeeeeseeensnney n 34 Screen setup 38 Contrast 38 Result Units a 39 ResultiConfim tiO ci 41 language Selecta dic 42 Setting the dat iii AR 43 Setting Me Mica 45 Setting the display options for date and time wn eecesssssseseeessssssssssnssnsssssessteeeeeseeesee 47 SO arias casetas laica a as 49 Beeper sain encase atian A 51 Auto Olinda ainia daa 54 Connection
65. etter on the code chips to tell them apart 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 con trol solution code chip 107 Control Testing and Quality Control MITA 9 15am 11 If performing more than one level select ac 999 Code 184 Par PT the level for this measurement Op Operator 1 04 19 2012 En MIA on The hourglass icon shows that the test strip is on One 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 04 19 2012 ea MA on The dropper icon flashes to indicate that the Op Operator o meter is ready to perform the test and is wait ing for the sample to be applied s P At the same time a 180 second countdown begins You must apply the sample within this 180 SEC time otherwise you will receive an error x message 04 19 2012 a 108 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 109 Control Testing and Quality Control 110 09 15 am QC 999 Level 1 Code 184 Par PT Op Operator 1 A 04 19 2012 E 09 15 am Qc 999 Level 1
66. ffer 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 under 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 141 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 ind
67. g a blood SaMple uniiicic nocniniinn annie 94 AUO O y pe POP o E a a aa 54 B nO ieehcecescdele inaani 86 91 Mask aaa 137 SY MDOlOGIES 20 ais 139 Barcode scanner sasetsazcscranci staan aaueat tactics a A E 24 A PP PP 18 19 27 SC ura taco adan ed nda 30 DPS ac AE 28 Battery Packs as ia eiii 18 19 27 125 31o 0 Y POPE POE A bloka bible 51 92 106 Blood sample testing cs enana rrnareenananna nera 79 99 c Capillary blood sample testing 79 99 CAE aaa 126 129 Meter HOUSING sii 127 Test Stip QUIdG us can aia als 128 COBgUIAtION PFOCESS viii ree 94 Code CHIP 83 84 INSCTINO unas e ge tddi 83 Code number 84 Comments AGOING COPA O 0 aretha a a adnan 98 Computer 57 Connection 57 Contras ccs mapon a a AAA 38 Control solution APPIVINO susana nn a iaa AE 109 Code chipisonaoaaninie a ea ec is 107 A a a eerie atest peice 102 Custom TANGG 2 2 testes naa a a a aahnent 71 72 153 Index D E a min aiciaticaAts 119 Dale e A aeons aa R ve nae aE 43 PES UCU UN mesnr A A tees 126 129 Display e can Penctssataectctecessasaash can ceceasac a a E 25 26 Display Mi 47 Disposal eee te id ica dot 17 28 81 99 111 E Error MESAS A tada 131 F Fingertip esenea a d an 94 l Icons Dropsen E N Dropper ena a R E E RA A o JU ge A o a an ttosctan iauestacetstas Identification plate A a A PC e pida 5 o A 58 69 OVOIVIGW get ci eds 58 Intrared inte TACO suas osa catalina 24 119 K e En
68. ge Selection Use this setting to select the language for all displays that contain text q De 42 wo a o 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 E Language 09 15 a 3 S 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 H to display the language of choice on the screen Qe 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 a
69. harging 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 interface 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 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 131 Button Icon Meaning Go to Main Menu OK save setting Cancel discard setting Return to previous menu ol D Reduce increase the value displayed Scroll through lists that are too long to be displayed all at once Se D 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 Apply sample the time left to apply sample is counted down in the display dodo 180 SEC 25
70. inator may specify what set tings are to be applied to a set of meters within a site or unit e g hospitals 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 66 for details on Operator Lockout see page 76 Computer Setup option For initial connection to a DMS the ability to communicate within a network has to be set up as follows E In the Setup menu the Connection option must be set to Computer see page 56 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 E 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 E Depending on DMS functionality available the DMS may transfer settings and lists to the meter as well as enable test results to
71. ities 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 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 140 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
72. itions are printed below in English only for legal reasons GPL Version 2 June 1991 1989 1991 Free Software Foundation Inc 51 Franklin Street Suite 330 Boston MA 02110 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 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 responsibil
73. lancing device that is approved for use by health care professionals such as the Accu Chek Safe T Pro or Safe T Pro Plus lancing devices or the CoaguChek Lancets professional use lancets available only in the United States Follow the manufacturer s instruc tions 4 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 uL 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 period of time may lead to an erroneous result as the coagulation process would already have started Testing a Blood Sample When applied from above the blood must cover the entire sample application area
74. llen battery packs and under no circumstances recharge them do not place in the base unit Overheating can cause the battery pack to catch fire or explode m Never throw the battery pack or the meter onto a fire Do not disman tle compress or pierce the battery pack as this could cause an inter nal short circuit that leads to overheating Donot place either the battery pack or the CoaguChek XS Pro meter on or in heating appliances such as a microwave conventional oven or radiator E Avoid prolonged exposure to direct sunlight e g when the meter is docked in the base unit Keep this in mind when positioning the base unit Battery fluid or materials leaking from damaged battery packs can irritate your skin or cause burns due to high temperatures E Avoid contact with leaking battery fluid In the event of accidental contact with the skin rinse with water If you get battery fluid in your eye s you should also seek medical attention Handle and dispose of battery packs with care Extreme temperatures reduce the charging capacity and usage period of the meter and the battery pack The battery pack begins charging as soon as the power adapter is connected or the meter is placed on an active Handheld Base Unit i e one connected to a power supply NOTICE Use only the specially designed battery pack provided by Roche Diagnostics Using any other type of battery may damage the system Save or download data
75. lly deleted The most recent result is always saved This applies both to patient results and to quality control tests 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 119 113 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 button for approximately 1 second 09 15 am 3 Wait until the main menu is displayed MTI ess am Us Patient Test UP Control Test 8 Review Results A Setup B 04 19 2012 114 09 15 am Ys Patient Test Review Results 04 19 2012 B 09 15 am y Patient Result UP QC Result 04 19 2012 B u y ja a ae El Review Results 4 Touch Review Results 5 Select the type of results you want to view m Display Patient Result memory E 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 115 Review Results
76. ly The CoaguChek XS Pro meter can be operated with either the power adapter provided four standard type AA alkaline non rechargeable batteries or a special 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 When working with the battery pack Unused battery packs lose their charge overtime and have to be recharged before they can be used After installing a new battery pack the meter should be charged for two hours in the base unit before testing Please note that the battery pack will only reach full capacity once it has been fully emptied and charged several times To save power the CoaguChek XS Pro 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 Off on page 54 27 ha Onani haok YC Dra Matar The CoaguChek XS Pro Mete Main Menu 09 15 am Us Patient Test WP Control Test EE toa psu q Setup gt 04 19 201
77. matically returns to the previous screen 7 Touch faz to return to the Screen menu 48 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 Pro meter You can display stored results chronologically by date and time or by person based on the Patient ID f 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 2 7 Ys Patient Test 2 Control Test ER Review Results O Setup 04 19 2012 Options ID Setup QC Settings 04 19 2012 09 15 am 15 am Beeper Auto Off Connection a Ce 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 49 Meter Setup 50 09 15 am Sort By Date Time Patient ID Patient Name Cy s 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 D
78. me Options Connection to a computer ID Setup the entire area QC Lockout QC Range Operator Lockout only available in combination with 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 60 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 EJ Review Results r Patient Test wo a 8 a D 3 Setup 04 19 2012 09 15 am Options ID Setup QC Settings 09 15 am 04 19 2012 04 19 2012 61 Meter Setup e 4 Using the keypad displayed on the screen enter the Admin password of choice A Js a WE MY The password can consist of up to 20 JOOOE GOO chatacters oponon 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
79. meter on you must touch Y to complete the first time setting Touch due 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 ka a 2 7 Ys ya O Patient Test Control Test ER Review Results i 04 19 2012 09 15 am Screen Options ID Setup QC Settings 04 19 2012 Result UrNts Result Confirmation Language Sele Date Time 09 15 am Se 04 19 2012 Ge 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 Date Time 47 Meter Setup 4 From the Date Time menu screen touch Set Date Format OEA 08 15 em Set Time a CIA The current settings are highlighted You can select one of the following display formats Format MM DD YYYY D CARA m Date DD MM YYYY Day Month Year a e g 30 09 2012 Time 21 E m Date MM DD YYYY Month Day Year ae e g 09 30 2012 Cx Cv m Date YYYY MM DD Year Month Day 04 19 2012 E e g 2012 09 30 m 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 auto
80. mm or larger in size a 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 Ensure that no air bubbles are introduced into the sample Protection against infection L 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 81 Testing a Blood Sample Preparing to test 1 Have the test strip container at hand 2 Make sure that the code chip supplied 0000 with these test strips is at hand CODE KMAIKOZ B i I st fa oaguChek XS PTE g_184 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 82 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 s
81. n Administrator has special rights 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 Pro 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 119 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 or scanner with or without an operator list being available 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 te
82. neering 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 following 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 Ber keley and its contributors 145 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
83. ns 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 COPYRIGHT 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 PER FORMANCE 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
84. ntle pressure to the reservoir to transfer the entire contents ofthe 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 103 Control Testing and Quality Control Performing a liquid quality control test 104 La 2 O Lu 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
85. omized to comply with local guidelines The QC Range function enables you to narrow the default range 09 15 am Ys Patient Test ge Control Test QC Lockout li Operator Lockout E S A Setup QC Settings S S 04 19 2012 E 04 19 2012 E Q etting ogam QC Range 09 15 am QC Range Default Range if 04 19 2012 e ye 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 Ifyou 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 71 Meter Setup QC Range 09 15 am o D a 2 3 Display mae EY Defa
86. ou may continue using the meter as desired If the problem persists contact Roche Technical Service at 1 800 428 4674 The two different message types are illustrated below Message Description 1 001 Battery Low Battery Low Status message A l 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 E 101 A 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 131 Troubleshooting E 406 Sample Error Sample Error Error message E 406 Touch XK 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 E 406 Power the meter off and remove the test strip Repeat the measurement using a new test strip 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 E 406 The CoaguChek XS PT Test strip may be used for patients under a com bination therapy of oral anticoagulants plus heparin injections For maximum heparin concentra tions which do not interfere with the test refer to the package insert Und
87. peared automatically after powering the meter on you must touch Y to complete the first date setting Touch dez to return to the Screen menu Meter Setup Setting the time 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 e 2 a 2 1 From the Main Menu touch Setup to open the meter settings O y Patient Test 2 From the Setup Menu touch Screen 2 Control Test I w From the Screen menu touch Date Time Review Results Setup 04 19 2012 09 15 am Screen Options ID Setup QC Settings 04 19 2012 09 15 am Result UrNts Result Confirmation Language Sele Date Time E Te En 04 19 2012 45 Meter Setup Set Date Date Time 09 15 am 04 19 2012 E 46 09 15 am Set Time Hour 9 M Format NH BJ e Minute 59 1 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
88. 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 for 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 obj
89. re recycling or disposing 29 CFR 1910 1030 Bloodborne pathogens Directive 2002 96 EC Directive on waste electrical and electronic equipment WEEE 17 General Care NOTICE Laser Scanner Clean the meter only with the solutions recommended see page 126 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 The built in barcode scanner emits a laser beam when activated The built in barcode scanner is a Class 1 laser according to EN 60825 1 2007 A WARNING A barcode does not need to be present for the laser scanner to become active Do not stare directly into the laser beam Batteries battery pack A WARNING v A 18 Exploding batteries battery pack Do not throw used batteries or battery packs into an open fire They may explode Disposal of used batteries and battery packs Do not dispose of the batteries and battery packs with normal domestic waste Dispose of them in accordance with applicable local regulations and directives and your facility s guidelines on the disposal of electronic waste equipment Battery pack A WARNING Possible hazards posed by the battery pack Damaged or swollen battery packs can overheat catch fire or leak Immediately cease use of CoaguChek XS Pro meters with damaged or swo
90. s 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 Pro system that are not answered in this manual contact your Roche representative In order to expedite troubleshooting please have ready your CoaguChek XS Pro meter its serial number this manual 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 package insert included with the CoaguChek XS PT Test strips shall prevail What can the system do for you The CoaguChek XS Pro 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 CoaguChek XS Pro meter displays test results in units equivalent to laboratory plasma meas urements Results may be displayed in three ways A International Normalized Ratio INR A combination of INR seconds or A combination of INR Quick
91. s of national or international laws on hazardous goods and where appli cable if special packaging and labeling requirements apply For short distances example between a facility s sites users may transport the battery packs either installed in the meter or separately by road without having to meet further require ments 125 Cleaning and Disinfecting the Meter A E 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 following solutions for cleaning disinfecting the meter housing and test strip guide 70 ethanol or isopropyl alcohol 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 126 Maintenance and Care Cleaning disinfecting the exterior meter housing Use the solutions recommended on page 126 for cleaning disinfecting the meter ext
92. s to Operator Login once Auto Off is triggered E If you do not work with operator IDs the meter switches to the Main Menu once Auto Off is triggered For information on Operator D see Operator ID on page 66 54 Meter Setup You may select from the following options Pao or 0 15am E Off meter never powers itself off ne Time until meter powers itself off 1 10 15 20 25 30 40 50 60 minutes Su 4 Touch D or H to select the time of choice in minutes or to switch the feature Lx sl 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 55 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 HE Control Test 3 From the Options menu touch ES Review Results Connection A Setup e 2 a 2 Us Patient Test 04 19 2012 09 15 am 09 15 am 04 19 2012 Connection 04 19 2012 E 56 Computer The CoaguChek XS Pro meter can connect with a computer or host system running appropriate software that is a DMIS must be installed To use this connectivity feature however you need the optional Handhel
93. scanner may be configured to accept only selected barcode symbol ogies e g EAN 13 Barcodes are not allowed Furthermore it is possible to define a barcode mask for Patient ID and Operator ID With masks being defined the meter checks a barcode after scanning and rejects it if it does not match the mask 122 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 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
94. st from these lists For more details see Data handling starting on page 119 Operator IDs can be selected from a list if available or read by the barcode scanner on the side of the meter If passwords were created they must be entered via the onscreen keypad Patient IDs can be entered by using the onscreen keypad or the barcode scanner on the side of the meter 58 Operator 2 2 2 3 E ic 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 m 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 The standard display of the Operator button means the Operator login is availa ble but not activated m 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 59 Kiatar Gatun IVieter setup 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 a Screen Result Units Date Ti
95. st unauthorized access by means of a strong pass word management Observe your own facility guidelines on password management where available or apply the following rules Characteristics of strong passwords E Passwords must not contain the user s account name or parts of the user s full name that exceed two consecutive characters Passwords must be at least eight characters in length Passwords must contain characters from at least three of the following four categories English uppercase alphabetic characters A through Z English lowercase alphabetic characters a through z Numeric characters 0 through 9 Non alphabetic characters for example Examples of weak passwords a uhxwze11 contains no upper case letter a UHXW13SF contains no lower case letter a UXXXXX7F contains the same character more than four times a x12useridF contains a substring of the user ID longer than four characters 21 Introduction Operating conditions To ensure that the meter functions properly please observe the following guidelines A Only use the meter at a room temperature between 15 C and 32 C 59 F and 90 F a Only use the meter at a relative humidity between 10 and 85 no condensation E 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
96. sult 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 x Cv 04 19 2012 E Result Units A Meter Setup Touch O or 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 lu ge Patient Test Control Test ie S Review Results i Setup 04 19 2012 09 15 am Screen Options ID Setup QC Settings 04 19 2012 Contrast Result Units Result Confirmation Language Selection Date Time 09 15 am es 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 39 Meter Setup 40 09 15 am INR SEC INR Q x
97. t the handheld base unit contacts or the battery pack E Do not drop the CoaguChek XS Pro meter the power supply unit or the battery pack and protect these against shaking and vibrations 16 Disposal of the System 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 electronic 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 befo
98. t 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 2 E a D Us UP 04 19 2012 Patient Test Control Test Setup Menu 09 15 am 74 Screen 04 19 2012 QC Lockout Operator Lockout E 04 19 2012 E 1 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 Lockout 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 m New Code Yes No applies every time a new test strip lot is used The general intervals are m No E Daily E Weekly 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
99. tead of batteries you can use a special rechargeable battery pack If you choose this option order the pack separately from Roche Diagnostics To recharge connect the power adapter to the CoaguChek XS Pro 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 AA batteries or the special Roche handheld battery pack This can lead to incor rect battery power level indications on the meter 29 Putting the Meter into Operation Inserting the batteries 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 30 Powering the meter on and off 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 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
100. tes that some screens have been skipped in these illustrations 15 Safety Information A Operator qualification Only trained healthcare professionals may operate the CoaguChek XS Pro system Operators must have received comprehensive instruction in the operation quality control and care of the CoaguChek XS Pro system Protection against infection Z There is a potential risk of infection Healthcare professionals using the WARNING CoaguChek XS Pro 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 m Use an auto disabling single use lancing device for each patient m Dispose of used lancets and needles in a sturdy sharps container with lid m Dispose of used test strips according to your institution s infection control policy E Follow all health and safety regulations in force locally A Avoidance of electrical shock fire and explosions Only use Roche original accessories cables power supply units bat tery packs and spare parts Third party cables power supply units and battery packs can cause the battery pack to explode or the meter to become damaged WARNING m Do not use loose power sockets or damaged power supply units cables plugs or battery packs Do not short circuit the power supply uni
101. ting a measurement You may now select a patient from the list scan a Patient ID using the barcode scanner create a new patient entry by touching New You may either read the ID using the bar code scanner or 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 When you start the test the screen is blank and Scan is displayed You may now scan a Patient ID using the barcode scanner If the patient ID is on the list the test will proceed If the patient ID is not on the list you will get an error message Note that the scanned Patient D must already be on the list that is sent from the DMS to the meter You cannot use the scanner to scan and enter a new Patient ID if the Patient ID is set to hidden 121 Extended Functionalities Patient list validation Depending on DMS settings you have the following options for patient list validation when work ing with Patient lists A A Patient ID does not have to be on the list to be used only valid for validation mode off E The meter displays a warning if the Patient ID entered is not on the list E The meter displays an error message if the ID was not found on the list of valid Patient IDs To proceed with the test you must scan if ID set to hidden or select if ID set to Required a valid Patient ID Barcode scanner Using a DMS the barcode
102. trip E operate the meter at an ambient temperature between 15 C and 32 C 59 F and 90 F a place the meter on a level stable surface table or hold it so it is roughly horizontal follow the information on correct handling of test strips in the package insert a keep the test strip guide and housing clean See also the chapter entitled Cleaning and Disinfecting the Meter starting on page 126 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 79 lesting a Blood sample Never a store the meter at extreme temperatures above 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 compl
103. trip lot is used so that the meter can read and store the lot information about that particular lot of test strips The CoaguChek XS Pro meter stores the data from up to 60 code chips that have been inserted a 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 a 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 83 Testing a Blood Sample 2 Check that the number on the code chip matches the number on the label of the test strip container y 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 84 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 secon
104. tthe 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 II A 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 you are prompted to enter a Patient ID If Required enter the Patient D then touch Y to move to the next screen CSoces Cheeta ELEELE 000000 000099 i y to move to the next screen The meter will assign the test a consecutive number a ignore the prompt and touch E If neither option was chosen a screen appears that prompts you to insert a test strip Continue with Step 8 89 Testing a Blood Sample With patient list 09 15 am PIDO1 Bs Smith aa Ys PIDO2 Jones Walther Ys PIDO3 Hamilton Fran Ys PIDO4 Miller Ted PID o Ro a gt 3 5 Touch Patient Test 6 Touch 4 and H to display the entry of choice Select the patient to be teste
105. uite 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 the 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 Engi
106. ult Range Custom Range Deviation from g target value 11 5 jas jes e L 04 19 2012 E 04 19 2012 72 If you selected Custom Range the QC Range screen opens and offers you the following options m Display target value On Off E Deviation from target value percentage value See page 71 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 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 vi 2 09
107. utomatically 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 47 Options shown in the Date and Time menus may vary depending on the chosen formats You can choose between the following display formats m Date Day Month Year e g 01 01 2012 m Date Month Day Year e g 01 01 2012 m Date Year Month Day e g 2012 01 01 E Time 24H or 12H 09 15 am a Patient Test UP Control Test he Sj Review Results Setup i 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 43 Meter Setup Date Time 09 15 am Set Date Set Time Format B Ce 04 19 2012 E 44 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 ap
108. vate Operator login 09 15 am 1 From the Main Menu touch Setup to open the meter settings Main Menu Uy Control Test 2 From the Setup Menu touch ID Setup 3 From the 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 al touch X to exit this menu without saving any changes The display automatically returns to the previous screen m it 04 19 2012 66 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 119 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 Ha Patient Test Control Test S O 09 15 am
109. y 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 80 Getting a good capillary blood sample To get a suitable drop of blood E 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 E 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 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

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