Roche CoaguChek XS Pro Operator'S Manual Download

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• Maintenance and Care

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Summary of Contents for CoaguChek XS Pro

Page 1: ...CoaguChek XS Pro P O I N T O F C A R E T E S T I N G Operator s Manual ...

Page 2: ...cleaning disinfection minor revisions Version 3 0 2010 10 Update to SW 03 Version 4 0 2013 01 Update to SW 03 01 new functions creation of document 0 6950540001 01 EN CAN 0 6950566001 01 FR CAN with altered instructions on cleaning disinfection for Canada Version 5 0 2015 12 Manual update added safety information on battery packs deleted appendix for addresses minor revisions ...

Page 3: ...0 6950540001 02 2015 12 EN CAN Operator s Manual Version 5 0 CoaguChek XS Pro ...

Page 4: ...U CHEK COAGUCHEK and SAFE T PRO are trademarks of Roche All other trademarks are the property of their respective owners On the packaging and on the identification plate of the instrument you may encounter the following symbols shown here with their meaning Caution consult accompanying documents Refer to safety related notes in the instructions for use accompanying this product Temperature limitat...

Page 5: ...ing conditions 20 Quality control 20 2 The CoaguChek XS Pro Meter 21 2 1 Overview of the meter elements 22 2 2 Buttons and icons overview 23 2 3 Power supply 25 3 Putting the Meter into Operation 27 3 1 Inserting the batteries 28 3 2 Powering the meter on and off 29 Checking the software version 30 4 Meter Setup 31 Note on presentation of screen elements in this manual 31 4 1 Settings summary 33 4...

Page 6: ...he meter 79 5 3 Performing a test 82 Accepting or rejecting a test result 91 Adding comments 92 STAT tests 94 6 Control Testing and Quality Control 95 6 1 Preparing to run a liquid quality control test 96 6 2 Performing a liquid quality control test 98 7 Review Results 105 7 1 Viewing test results 106 Display patient result memory 108 Display QC quality control result memory 109 8 Extended Functio...

Page 7: ... compartment 130 Approved cleaning agents 130 How to perform maintenance cleaning of the test strip guide 130 How to perform maintenance cleaning of the battery compartment 132 9 6 Cleaning the scanner window 133 10 Troubleshooting 135 Additional information on error E 406 136 Errors and unusual behavior without error messages 137 11 General Product Specifications 139 11 1 Technical data 139 Sampl...

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Page 9: ...rtant 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 accord ing to your needs before initial use Refer to chapter 4 Meter Setup Be sure to read the Important safety instructions and additional information section in this chapter before operatin...

Page 10: ...rips shall prevail What can the system do for you The CoaguChek XS Pro system makes coagulation test ing 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...

Page 11: ...ility 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 contains a lyophilized rea gent The reactive components of this reagent consist of thromboplastin and a peptide substr...

Page 12: ...eness to hazards which are generic or directs the reader to related safety information WARNING WARNING Indicates a hazardous situation which if not avoided could result in death or serious injury CAUTION CAUTION Indicates a hazardous situation which if not avoided could result in minor or moderate injury NOTICE NOTICE Indicates a hazardous situation which if not avoided may result in damage to the...

Page 13: ...1 13 Illustrations in this manual show two different kinds of hands Hand without glove Hand with glove A dashed arrow between screen illustrations indicates that some screens have been skipped in these illustrations ...

Page 14: ...dhere to Standard Precautions when handling or using the CoaguChek XS Pro system All parts of this system should be consid ered potentially infectious and are capable of transmitting blood borne pathogens between patients and between patients and healthcare professionals Use gloves Wear a new pair of clean gloves for testing each patient Wash hands thoroughly with soap and water before putting on ...

Page 15: ...s Do not short circuit the power supply unit the hand held base unit contacts or the battery pack Do not drop the CoaguChek XS Pro meter the power supply unit or the battery pack and protect these against shaking and vibrations WARNING Infection by a potentially biohazardous instrument The CoaguChek XS Pro system or its components must be treated as potentially biohazardous waste Decontam ination ...

Page 16: ...use an internal short circuit that leads to overheating Do not place either the battery pack or the CoaguChek XS Pro meter on or in heating appli ances such as a microwave conventional oven or radiator Avoid prolonged exposure to direct sunlight e g when the meter is docked in the handheld base unit Keep this in mind when positioning the handheld base unit Battery fluid or materials leaking from d...

Page 17: ... regulations and directives Contact your local council local authority or the manufacturer of the used batteries for advice on correct disposal NOTICE Clean the meter only with the solutions recommended see page 119 Using other solutions may result in incorrect operation and possible system failure Do not let cleaning solution enter the instrument Make sure that the meter is thoroughly dried after...

Page 18: ... 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 WARNING A barcode does not need to be present for the laser scanner to become active Do not stare directly into the laser beam Do not use the meter near strong electromagnetic fields wh...

Page 19: ...t 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 Example...

Page 20: ...ghly horizontal Quality control The meter has a number of built in quality control func tions A check of the electronic components and func tions 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 based on the code chip data A two level onboard quality control test and patient res...

Page 21: ...The CoaguChek XS Pro Meter 2 21 2 The CoaguChek XS Pro Meter A B C D G I J F H K L E ...

Page 22: ...egrated barcode scanner can read operator and patient IDs into the meter F Tab for battery compartment cover G Battery compartment cover Covers the battery compartment 4 standard AA alkali manganese batteries or the rechargeable battery pack H Charging terminals Used for power supply and or charging the battery pack when the meter is docked in the optional Handheld Base Unit I Code chip slot Inser...

Page 23: ...in Menu OK save setting Cancel discard setting Return to previous menu Reduce increase the value displayed Scroll through lists that are too long to be displayed all at once 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 mete...

Page 24: ... 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 memo...

Page 25: ...cally 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 set tings will still be there when you power the meter back on Refer to Auto Off on page 50 The test strip guide cover is open Communicatio...

Page 26: ... 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 set tings connect the power adapter while you change the batteries or handheld battery pack Main Menu 09 15 am 04 19 2012 Control Test Review Results Setup Patient Test Dispose of used batteries a...

Page 27: ...se this option order the pack separately from Roche Diagnostics To recharge con nect 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 batter ies or the dedicated Roche handheld battery pack We do not recommend the use of off the shelf re...

Page 28: ...batteries 1 With the meter powered off press the battery com partment 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 ...

Page 29: ...ring the meter on and off 1 Place the meter on a level vibration free surface or hold it in your hand so it is roughly horizontal 2 Power the meter on by pressing the button for approximately 1 second 3 To power the meter off after use press the button for approximately 1 second You can also power on the meter directly by inserting a test strip or connecting the power adapter ...

Page 30: ...the Roche logo the meter briefly displays the Init for initialization screen Here you can check which software version is currently running on your meter The Init screen shown here is for illustration pur poses only Version numbers on your meter may differ Init CoaguChek XS Pro 03 01 03 ...

Page 31: ...h 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 If you have not set the date and time after powering on for the first time or because the batteries were removed from the meter for more than 10 minu...

Page 32: ...eter settings 2 Select the group of settings of choice see the Settings summary following this section Main Menu 09 15 am 04 19 2012 Control Test Review Results Setup Patient Test Setup Menu 09 15 am 04 19 2012 ID Setup QC Settings Options Screen ...

Page 33: ...the setup areas that can be accessed on the meter Setup Screen Options ID Setup QC Settings Result Units QC Lockout Beeper Operator Contrast QC Range Sort Admin Language Selection Result Confirmation Operator Lockout Auto Off Date Time STAT Test Config Connection Patient ...

Page 34: ...C INR Q Result Confirmation Enable Disable Language Selection Dansk Deutsch English Español Français Italiano Nederlands Norsk Português Suomi Svenska Date Time Date 01 01 2012 Time 12 00 am Date formats DD MM YYYY 01 01 2012 MM DD YYYY 01 01 2012 YYYY MM DD 2012 01 01 Time formats 24 hour time format 24h 12 hour time format 12h with am pm ...

Page 35: ...re labeled with an asterisk Group Subgroup Setting Values Options Sort Date Time Patient ID Patient Name Beeper Beeper Off Low Medium High Key Click Off On Auto Off minutes Off 1 5 10 15 20 25 30 40 50 60 Connection Off Computer Printer ...

Page 36: ...nt No Optional Required QC Settings QC Range Default Range Custom Range Display Target Value On Off Deviation from Target Value Percentage Operator Lockout only if the Operator option is set to Active and an operator list is available Off Weekly Monthly Every 3 months Every 6 months Yearly QC Lockout New code Yes No General No Daily Weekly Monthly STAT Test Config Enable Disable Quantity ...

Page 37: ...ange from 0 to 10 Contrast 0 makes the display very dark Contrast 10 makes the display very light 5 Touch to save this setting or touch to exit this menu without saving any changes The display automatically returns to the previous screen Main Menu 09 15 am 04 19 2012 Control Test Review Results Setup Patient Test Setup Menu 09 15 am 04 19 2012 ID Setup QC Settings Options Screen Screen 09 15 am 04...

Page 38: ...R INR and seconds INR and Quick value in 4 Touch the button to select the unit of measure of choice Your selection is now highlighted 5 Touch to save this setting or touch to exit this menu without saving any changes The display automatically returns to the previous screen Main Menu 09 15 am 04 19 2012 Control Test Review Results Setup Patient Test Setup Menu 09 15 am 04 19 2012 ID Setup QC Settin...

Page 39: ... menu touch Result Confirma tion 4 Touch Enable or Disable Your selection is now highlighted 5 Touch to save this setting or touch to exit this menu without saving any changes The display automatically returns to the previous screen Main Menu 09 15 am 04 19 2012 Control Test Review Results Setup Patient Test Setup Menu 09 15 am 04 19 2012 ID Setup QC Settings Options Screen Screen 09 15 am 04 19 2...

Page 40: ...ge Selec tion The current language setting is highlighted white type on a blue background You can select either Dansk Deutsch English Español Français Italiano Nederlands Norsk Português Suomi Svenska Main Menu 09 15 am 04 19 2012 Control Test Review Results Setup Patient Test Setup Menu 09 15 am 04 19 2012 ID Setup QC Settings Options Screen Screen 09 15 am 04 19 2012 Language Selection Result Co...

Page 41: ...a long period without power the input field for the date automatically 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 Language 09 15 am 04 19 2012 Deutsch English Español Dansk Français Both Date and Time display formats are controlled by the Format options you s...

Page 42: ...utomatically returns to the previous screen If this setup menu appeared automatically after powering the meter on you must touch to complete the first date setting 7 Touch to return to the Screen menu Main Menu 09 15 am 04 19 2012 Control Test Review Results Setup Patient Test Setup Menu 09 15 am 04 19 2012 ID Setup QC Settings Options Screen Screen 09 15 am 04 19 2012 Language Selection Result Co...

Page 43: ...t the hours then the min utes 6 Touch to save this setting or touch to exit this menu without saving any changes The display automatically returns to the previous screen If this setup menu appeared automatically after powering the meter on you must touch to complete the first time setting 7 Touch to return to the Screen menu Main Menu 09 15 am 04 19 2012 Control Test Review Results Setup Patient T...

Page 44: ...ch Format The current settings are highlighted You can select one of the following display formats Date DD MM YYYY Day Month Year e g 30 09 2012 Date MM DD YYYY Month Day Year e g 09 30 2012 Date YYYY MM DD Year Month Day e g 2012 09 30 Time 24H or 12H Main Menu 09 15 am 04 19 2012 Control Test Review Results Setup Patient Test Setup Menu 09 15 am 04 19 2012 ID Setup QC Settings Options Screen Scr...

Page 45: ...lighted 6 Touch to save this setting or touch to exit this menu without saving any changes The display automatically returns to the previous screen 7 Touch to return to the Screen menu Date Time 09 15 am 04 19 2012 Format Set Time Set Date Format 09 15 am 04 19 2012 Date DD MM YYYY MM DD YYYY YYYY MM DD Time 24H 12H ...

Page 46: ... Patient ID If you are working with a DMS and a patient list you can also display the patient list and the stored results sorted by Patient Name 1 From the Main Menu touch Setup to open the meter settings 2 From the Setup Menu touch Options 3 From the Options menu touch Sort Options 09 15 am 04 19 2012 Auto Off Connection Beeper Sort Main Menu 09 15 am 04 19 2012 Control Test Review Results Setup ...

Page 47: ...n is now highlighted 5 Touch to save this setting or touch to exit this menu without saving any changes The display automatically returns to the previous screen The sort option Patient Name is available only when used together with a patient list Patient lists can only be created with a DMS For more details see Data han dling starting on page 111 Sort 09 15 am 04 19 2012 Date Time Patient ID Sort ...

Page 48: ... 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 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 W...

Page 49: ...ing for the Beeper then touch the button with the setting of choice for the Key Click Both selections are now highlighted 5 Touch to save this setting or touch to exit this menu without saving any changes The display automatically returns to the previous screen Options 09 15 am 04 19 2012 Auto Off Connection Beeper Sort Main Menu 09 15 am 04 19 2012 Control Test Review Results Setup Patient Test S...

Page 50: ...ouch Auto Off Options 09 15 am 04 19 2012 Auto Off Connection Beeper Sort Main Menu 09 15 am 04 19 2012 Control Test Review Results Setup Patient Test Setup Menu 09 15 am 04 19 2012 ID Setup QC Settings Options Screen If the meter is connected to the power adapter or the Handheld Base Unit the Auto Off function has a differ ent effect If you work with operator IDs the meter switches to Operator Lo...

Page 51: ...s to the previous screen Connection In the Connection menu you can configure the data exchange with external devices The meter can be con nected either to a computer or a printer 1 From the Main Menu touch Setup to open the meter settings 2 From the Setup Menu touch Options 3 From the Options menu touch Connection Auto Off 09 15 am 04 19 2012 5 Minutes Options 09 15 am 04 19 2012 Auto Off Connecti...

Page 52: ...S to set up operator lists or patient lists lists of patients to be tested This eliminates the need for manual entry of these data In addition you can transfer test results stored in the meter to other systems for archiving or further evaluation The option Computer controls the meter s ability to com municate with a computer or a network 4 Touch Computer Your selection is now highlighted 5 Touch t...

Page 53: ...or memory screen touch Options 09 15 am 04 19 2012 Auto Off Connection Beeper Sort Main Menu 09 15 am 04 19 2012 Control Test Review Results Setup Patient Test Setup Menu 09 15 am 04 19 2012 ID Setup QC Settings Options Screen The printer icon only appears if the printer function is activated Otherwise it is not displayed If you work with the meter in a language other than English With the excepti...

Page 54: ...sary 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 exter nally must be transferred to the meter enab...

Page 55: ... the onscreen keypad Patient IDs can be entered by using the onscreen keypad or the barcode scanner on the side of the meter For more information on working with operator and patient ID barcodes see Data handling starting on page 111 The buttons in the ID Setup menu show what the current settings are this is just an example the screen may look different on your meter The standard display of the Ad...

Page 56: ...h a data management system 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 3 From the ID Setup menu touch Admin 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 pass word must also be entered before you...

Page 57: ...first entry 10 Touch 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 ID Setup menu After you exit the Setup menu only an authenticated administrator may further edit the setup areas as listed before see page 56 Pay close attention to the buttons you press because the c...

Page 58: ...ayed The Admin button is highlighted which means an Admin password is active 4 Touch Admin 5 Using the keypad displayed on the screen enter and confirm the new Admin password of choice Admin A B C D E F G H I J K L M N O P Q R S T U V W X Y Z 123 09 15 am ID Setup 09 15 am 04 19 2012 Patient Operator Admin Main Menu 09 15 am 04 19 2012 Control Test Review Results Setup Patient Test Setup Menu 09 1...

Page 59: ...touch 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 Admin A B C D E F G H I J K L M N O P Q R S T U V W X Y Z 123 09 15 am ID Setup 09 15 am 04 19 2012 Patient Operator Admin Main Menu 09 15 am 04 19 2012 Control Test Review Results Setup Patient Test Setup Menu 09 15 am 04 19 20...

Page 60: ... for set ting up the Operator login Your selection is now highlighted 5 Touch to save this setting or touch to exit this menu without saving any changes The display automatically returns to the previous screen 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 D...

Page 61: ...put 4 Touch the button with the setting of choice Your selection is now highlighted 5 Touch to save this setting or touch 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 If you want to create a list of Patient IDs from which you can select a patient for testing additional soft...

Page 62: ...atient ID must have Max Length Enter the maximum number of characters 1 20 the Patient ID can have 7 Touch the button with the format of choice for the Patient ID Your selection is now highlighted 8 Touch or to set the number of characters length of choice 9 Touch to save this setting or touch to exit this menu without saving any changes The display automatically returns to the previous screen Pat...

Page 63: ...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 success fully before the meter is available again for testing either by the operator or in general The op...

Page 64: ...laying the target value along with a control test result or not displaying the target value with the control test result 4 Touch the button with the setting of choice Your selection is now highlighted If you selected Default Range touch to save this setting or touch to exit this menu without saving any changes If you selected Custom Range touch to pro ceed with corresponding settings or touch to e...

Page 65: ...ge 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 correlation between values expressed as INR and values expressed as Quick if you calculate the per centage deviation 11 5 in the example using the Quick...

Page 66: ... 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...

Page 67: ...o defining time intervals QC Lockout can also be used to specify that a quality control test must be car ried out when a new test strip lot is used New Code 1 From the Main Menu touch Setup to open the meter settings 2 From the Setup Menu touch QC Settings 3 From the QC Settings menu touch QC Lockout QC Settings 09 15 am 04 19 2012 QC Lockout Operator Lockout STAT Test Config QC Range Main Menu 09...

Page 68: ... to select the interval of choice Your selection is now highlighted 7 Touch to save this setting or touch to exit this menu without saving any changes 8 For every option except for No you must now indi cate the number of levels in which the quality con trol must be performed 9 Touch to save this setting or touch to exit this menu without saving any changes The display automatically returns to the ...

Page 69: ...perator Lockout If this button is disabled grayed out either no operators have been set up or the Operator ID option has been deactivated QC Settings 09 15 am 04 19 2012 QC Lockout Operator Lockout STAT Test Config QC Range Main Menu 09 15 am 04 19 2012 Control Test Review Results Setup Patient Test Setup Menu 09 15 am 04 19 2012 ID Setup QC Settings Options Screen The option of setting up an Oper...

Page 70: ...uch to save this setting or touch to exit this menu without saving any changes 8 For every option except for No you must now indi cate the number of levels in which the quality con trol must be performed 9 Touch to save this setting or touch to exit this menu without saving any changes The display automatically returns to the previous screen Op Lockout 09 15 am 04 19 2012 Weekly Monthly Every 3 Mo...

Page 71: ...T Tests STAT Short TurnAround Time You can set the number of tests up to a maximum of nine permitted beyond the lockout Once the number of STAT Tests allowed has been reached additional tests cannot be performed until you have successfully com pleted a quality control test The default setting is three STAT tests 1 QC operator or new lot lockout The results of STAT tests are always identified by th...

Page 72: ...ighlighted 5 If you have enabled the option touch and to set the number of additional tests 6 Touch to save this setting or touch to exit this menu without saving any changes QC Settings 09 15 am 04 19 2012 QC Lockout Operator Lockout STAT Test Config QC Range Main Menu 09 15 am 04 19 2012 Control Test Review Results Setup Patient Test Setup Menu 09 15 am 04 19 2012 ID Setup QC Settings Options Sc...

Page 73: ... Tubes Bulbs optional Cotton ball and alcohol wipe 5 1 Important notes Always close the strip container immediately after remov ing a test strip operate the meter at an ambient temperature between 15 C and 32 C 59 F and 90 F 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 keep the...

Page 74: ...k 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 Protection against infection When collecting samples always observe the general precautions and guidelines relating to blood sampling see page 14 Dispose of all test strips used for patient testing in accordance with the disposal policy ...

Page 75: ...e these techniques until the fingertip has increased color 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 CAUTION When washing and disinfecting th...

Page 76: ...edle at least 23 G approx 0 65 mm or larger in size Discard the first four drops of blood collected within the first 10 seconds Then immediately apply one drop of blood at least 8 μL directly onto the target area of the test strip Ensure that no air bubbles are introduced into the sample Protection against infection When collecting samples always observe the general precautions and guidelines rela...

Page 77: ...o 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 recom mend that you leave the code chip in the meter to protect the electrical contacts in the meter from becoming dirty 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...

Page 78: ...t the number on the code chip matches the number on the label of the test strip container 3 Slide the new code chip into the code chip slot as shown until you feel it snap into place If the code chip is missing or incorrectly inserted error messages appear in the display refer to the Trouble shooting section of this manual ...

Page 79: ...pproximately 1 second The next steps depend on whether you work with the function Operator ID set to inactive or active see Data handling on page 111 If the function Operator ID is inactive 3 Wait until the Main Menu is displayed You can also power on the meter directly by inserting a test strip or connecting the power adapter Main Menu 09 15 am 04 19 2012 Control Test Review Results Setup Patient...

Page 80: ...f 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 1 For configuring operator and patient IDs see page 117 Operator ID A B C D E F G H I J K L M N O P Q R S T U V W X Y Z 123 09 15 am Scan 2 A list of supported barcode symbologies can be found...

Page 81: ...erator wants to perform additional tests touch Logout to log out this button is available only when the Operator ID is acti vated The meter returns to the display of the operator pick list Note Extended data handling functionality is depend ent on the capabilities of the particular Data Manage ment System DMS being used and may vary For more details see Data handling starting on page 111 Operator ...

Page 82: ... available but a lockout is displayed a test can only be performed as a STAT test if this function is enabled and if there are still STAT tests available For more details on STAT test configuration see pages 71 and 94 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 t...

Page 83: ...If Required enter the Patient ID then touch to move to the next screen If Optional ignore the prompt and touch to move to the next screen The meter will assign the test a consecutive number If neither option was chosen a screen appears that prompts you to insert a test strip Continue with Step 8 1 For configuring operator and patient IDs see page 117 Patient ID A B C D E F G H I J K L M N O P Q R ...

Page 84: ...d from the list 7 If the patient is not in the list touch New to create a new entry You must now enter a Patient ID using the keypad Test 09 15 am 04 19 2012 PID02 Jones Walther PID03 Hamilton Fran PID04 Miller Ted PID01 Smith Henry New Scan PID05 Reed William Patient ID A B C D E F G H I J K L M N O P Q R S T U V W X Y Z 123 09 15 am Scan ...

Page 85: ...patient ID field The scanner turns off after 10 seconds if a bar code is not scanned Note Extended data handling functionality is depend ent on the capabilities of the particular Data Manage ment System DMS being used and may vary For more details see Data handling starting on page 111 1 A list of supported barcode symbologies can be found in Appendix A 3 on page 145 WARNING A barcode does not nee...

Page 86: ...ip 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 indi cates that the meter has detected the test strip provided the beeper is enabled Test 09 15 am 04 19 2012 P ID PID01 Müller David Op Schulz Par PT Exposure to external influences such as humidity may deteriorate the test strips and may lead to error mes sages Therefore alwa...

Page 87: ...p 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 Test 09 15 am 04 19...

Page 88: ...al 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 coagula tion process would already have started WARNING Use only a lancing device that is approved for use by healthcare professionals such as the Accu Chek Safe T Pro or Safe T Pro Plus lancing devices or the ...

Page 89: ...mbol disappears and the test starts When applied from above the blood must cover the entire sample application area 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 Test 09 15 am 04 19 2012 P ID PID01 Code 184 Smith Henry Op Operator 1 Par PT ...

Page 90: ...tations and interferences included in the limi tations section of the test strip package insert 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 Test 09 15 am 04 19 2012 P ID PID01 Cod...

Page 91: ...n If you reject the result this test result is no longer dis played However the test entry is stored Test 09 15 am 04 19 2012 P ID PID01 Code 184 2 5INR Smith Henry Op Operator 1 Par PT Measurement Result OK 21 Q 04 19 2012 09 14 am Accept Reject Comment Required A comment is required if you reject a result Please enter a comment I 009 Test 09 15 am 04 19 2012 P ID PID01 Code 184 Smith Henry Op Op...

Page 92: ...he desired comment s touch to return to the results screen 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 The printer icon only appears if the printer function is activated Otherwise it is not displayed Test results are also saved when the meter is powered off in the results scree...

Page 93: ...7 Clean the meter if necessary see Chapter 9 Main tenance and Care Remove 09 15 am 04 19 2012 Protection against infection When collecting samples always observe the general precautions and guidelines relating to blood sampling see page 14 Dispose of all test strips used for patient testing in accordance with the disposal policy of your laboratory or practice see page 14 ...

Page 94: ...sts 3 Perform the test When a STAT test is performed this information is stored with the result The number of STAT tests allowed is reduced by 1 After all pending quality control tests are performed the specified number of STAT tests is availa ble again in case of a new lockout The default setting is three for the number of STAT tests allowed when in QC Lockout Main Menu 09 15 am 04 19 2012 Contro...

Page 95: ...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 pack Test strips that came with the code chip mentioned above Bottles of CoaguChek XS PT Controls ...

Page 96: ...e test strips is at hand 3 Make sure the bottle of freeze dried lyophilized con trol plasma and the dropper for making the control solution are at hand This bottle should remain refrig erated 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 dro...

Page 97: ...ty control test 10 Swirl the bottle using a circular motion to com pletely 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 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 r...

Page 98: ...displayed or log on as described on page 80 4 Check the battery level 5 Check that the date and time are correct Correct any wrong entries as described in Chapter 4 Meter Setup Setting the date 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 b...

Page 99: ... test strip guide in the direction indicated by the arrows 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 mes sages Therefore always close the container immedi ately after removing a test strip Main Menu...

Page 100: ... a new control solution remove the strip code chip from the meter and insert the code chip that came with the control solution instead 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...

Page 101: ...ol solution The dropper icon flashes to indicate that the meter is ready to perform the test and is waiting for the sample to be applied At the same time a 180 second countdown begins You must apply the sample within this time otherwise you will receive an error message QC Test 09 15 am 04 19 2012 180 SEC QC 999 Code 184 Op Operator 1 Par PT Level 1 QC Test 09 15 am 04 19 2012 QC 999 Code 184 Op O...

Page 102: ... 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 semicircular transparent sample application area on top of the test strip Do not add more control solution ...

Page 103: ...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 The printer icon only appears if the printer function is activated Otherwise it is not displayed QC Test 09 15 am 04 19 2012 0 9 INR Fail 110 Q 04 19 2012 09 15 am QC 99...

Page 104: ...ip 18 Remove the test strip from the meter 19 Power the meter off 20 Remove the quality control code chip from the meter and store it with the controls 21 Clean the meter if this becomes necessary see Chapter 9 Maintenance and Care If you are performing a 2 level control you will now be asked to proceed with the second level QC Comment 09 15 am 04 19 2012 New Control Lot Cleaned Meter Doctor Notif...

Page 105: ...olution code chips are stored If you are using operator and or patient lists a maximum of 5000 Operator and 4000 Patient IDs is allowed If memory is full when you perform a test the oldest result is automatically deleted The most recent result is always saved This applies both to patient results and to quality control tests In order to avoid the loss of stored test results you can archive this dat...

Page 106: ...it in your hand so it is roughly horizontal 2 Power the meter on by pressing the button for approximately 1 second 3 Wait until the main menu is displayed To power the meter off after use press the button for approximately 1 second Main Menu 09 15 am 04 19 2012 Control Test Review Results Setup Patient Test ...

Page 107: ...bed 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 Printer icon The printer icon only appears if the printer function is activated Otherwise it is not displayed Main Menu 09 15 am 04 19 2012 Control Test Review Results Setup Patient Test Memory 09 15 am 04 19 2012 QC Resul...

Page 108: ...ntry you want to open The entry is displayed 3 Touch The results for the selected patient are displayed Memory 09 15 am 04 19 2012 P ID PID01 Code 184 2 5INR Smith Henry Op Operator 1 Par PT Doctor Notified Sick Travel 21 Q 04 18 2012 11 31 am Memory 09 15 am 04 19 2012 P ID PID01 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 Memory ...

Page 109: ... the entry of choice on the screen 2 Touch the entry you want to open The entry is displayed Memory 09 15 am 04 19 2012 1 2 INR New Control Lot New Strip Lot 78 Q 04 18 2012 11 31 am QC 999 Code 184 Op Operator 1 Par PT Level 1 1 0 1 4 INR 53 99 Q Pass QC 09 15 am 04 19 2012 04 17 2012 10 05 am QC 234 Pass 04 16 2012 10 07 am QC 623 Pass 04 15 2012 10 30 am QC 333 Pass 04 18 2012 11 31 am QC 999 P...

Page 110: ...7 Review Results 110 This page intentionally left blank ...

Page 111: ... 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 Transferring all stored test results with the corre sponding 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 ne...

Page 112: ...asily be set once and distributed to all meters The option of setting up an Operator Lockout is availa ble 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 60 for details on Operator Lockout see page 69 When using operator and or patient lists and the lists are set to be hidden operator login and or pati...

Page 113: ... refer to the manual of the Handheld Base Unit and the Technical Note stored on the Handheld Base Unit itself Place the meter on a Handheld Base Unit that is connected to the network The meter will automat ically 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 Depending on DMS functionality available the DMS may transfer ...

Page 114: ...nd available on the meter The Operator can either select the ID from the dis played list on the login screen or scan the ID using the barcode scanner If so configured by the Administrator the Operator may also be required to enter a password to log in Operator list is activated and available on the meter but set to hidden The Operator can only log in via a barcode scan If so configured by the Admi...

Page 115: ...ered manually via the onscreen keypad or read in via a barcode scan The Patient ID is stored with the test result 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...

Page 116: ... off The meter displays a notification if the Patient ID entered is not on the list and validation mode notify was selected in the DMS The meter displays an error message if the ID was not found on the list of valid Patient IDs and valida tion mode required was selected in the DMS To proceed with the test you must scan if ID set to hidden or select if ID set to Required a valid Patient ID If the l...

Page 117: ...ing 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 Com ments 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...

Page 118: ...ation Will Repeat Test Changed Dosing 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 Tech nical Note stored on the Handhel...

Page 119: ...and shipping Storage Store the system and test strips in the same envi ronment in which they are used Do not store the meter in direct sunlight or under extreme temperature conditions Observe the limits for temperature and humidity when storing and using the meter see Chapter 11 ...

Page 120: ...round in the packaging Also observe any other applicable national regulations 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 basis of national or international laws on hazardous goods and where applicable if special packaging and labeling requirements apply ...

Page 121: ... is the physical removal of organic soiling e g dirt or other foreign material from the meter surface Disinfecting is the removal of most but not all disease causing and other types of microorganisms blood borne pathogens from the meter Observe the disinfection guidelines of your institution Protective gloves should always be worn when cleaning and disinfecting the device NOTICE Follow the procedu...

Page 122: ...hared If it is not possible for each individual patient to have a dedi cated POC device the meters must be properly cleaned and disinfected after every use or before being used on the next patient following the guidelines given below 3 1 FDA Public Health Notification Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens Initial Communication 2010 http...

Page 123: ... 0 125 and isopropyl alcohol 14 85 We recommend Sani Cloth Plus Germicidal Disposable Cloths This product contains the approved active ingredients and is licensed for use in Canada NOTICE Damage to the instrument Use only products containing the approved active ingre dients Do not use any other cleaning or disinfecting solutions as this could result in damage to the system components For technical...

Page 124: ...t and back The test strip guide and test strip guide cover If you notice any signs of deterioration after cleaning or disinfecting your meter stop using it and contact Roche Care Center at 1 877 273 3433 for assistance Ensure that the blue test strip guide cover remains tightly closed while cleaning or disinfecting the exterior housing NOTICE Do not allow liquid to enter the test strip guide or po...

Page 125: ...the the cloth before using it Do not let liquid accumulate near any opening Carefully wipe around the cover of the test strip guide and other openings Ensure that no liquid enters the meter Protective gloves should always be worn when cleaning and disinfecting the meter 2 Dry the exterior After cleaning the housing wipe away any residual moisture and fluids with a dry lint free cloth ...

Page 126: ... liquid enters the meter To properly disinfect let the meter sit wet for a contact time of at least 2 minutes or as instructed by the manufacturer in the product labeling Always refer to the manufacturer s labeling for contact time recommendations 4 Dry the exterior After the required contact time dry the housing thoroughly with a dry lint free cloth Visually verify that no residual moisture is se...

Page 127: ...ter cleaning dry the test strip guide cover thoroughly with a dry lint free cloth 3 Clean the interior test strip guide Hold the meter upright with the test strip guide facing down Clean the easily accessible area shown in the illustration white area and its black surrounding frame with a Sani Cloth Plus Germicidal Cloth Remove any excess moisture from the cloth Do not clean beyond the white area ...

Page 128: ...r with a dry lint free cloth 5 Disinfect the interior test strip guide Hold the meter upright with the test strip guide facing down Wipe the easily accessible area shown in the illustration white area and its black surrounding frame with a fresh germicidal cloth Do not clean beyond the white area inside the meter Ensure the germicidal cloth is only damp not wet To properly disinfect let the test s...

Page 129: ...for at least 10 minutes before re attaching the test strip guide cover and testing again Visually verify that no residual moisture is seen anywhere on the test strip guide and cover at the completion of cleaning and disinfecting Ensure that the test strip guide and cover are completely dry before assembling them 7 Re attach the test strip guide cover Close the cover and make sure it snaps into pla...

Page 130: ...inspected and cleaned periodi cally as necessary or at least once per month Approved cleaning agents Battery compartment Use a lint free cloth slightly dampened with water Test strip guide Use a cotton swab slightly dampened with water How to perform maintenance cleaning of the test strip guide 1 Open the cover With the meter powered off use your thumbnail to open the cover of the test strip guide...

Page 131: ...lack surrounding frame with a water dampened cotton swab Do not clean beyond the white area inside the meter Ensure the swab is only damp not wet Wipe away residual moisture and fluids Carefully wipe the test strip guide dry using a dry cotton swab Ensure that the test strip guide and cover are completely dry before assembling them 3 Close the cover and make sure it snaps into place NOTICE Damage ...

Page 132: ... any residue from the areas highlighted in blue in the illustration below on the meter as well as on the battery compartment cover 3 Carefully dry the cleaned areas of the battery com partment cover and meter using a fresh lint free cloth Leave the parts disassembled to completely dry for at least one hour You can either leave the batteries inserted in the battery compartment cover or remove them ...

Page 133: ...back onto the meter and close the battery compartment 9 6 Cleaning the scanner window The scanner window should be cleaned periodically Use a clean dry cloth to wipe the scanner window NOTICE Damage through moisture entering the instrument Ensure that no liquid enters the meter If moisture enters the meter it may cause malfunction of the instrument ...

Page 134: ...9 Maintenance and Care 134 This page intentionally left blank ...

Page 135: ... are accompanied by a description of the error and a pos sible solution Take the action suggested on screen to resolve the prob lem If the error disappears you may continue using the meter as desired If the problem persists contact Roche see page 142 The two different message types are illustrated below Message Description I 001 Battery Low Status message Touch to proceed with the next step E 101 ...

Page 136: ...der 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 8 INR 5 Quick may receive an E 406 message on the meter display If this error mes sage ...

Page 137: ...rly 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 unexpected result Refer to the package insert for the test strips Automatic shutdown The meter powers off after a configurable time without activity e g pressing a key touching the screen to con serve energy Reactivate the meter screen ...

Page 138: ...10 Troubleshooting 138 This page intentionally left blank ...

Page 139: ...ing 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 Battery operation 4 x 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 ...

Page 140: ...iled product data and limitations Temperature range Meter without batteries 25 C to 70 C 13 F to 158 F Temperature range Meter with batteries 10 C to 50 C 14 F to 122 F Relative humidity 10 to 85 no condensation Item Description Remarks CoaguChek XS PT Test 24 test strips International edition not available in the US CoaguChek XS PT Test 2 x 24 test strips CoaguChek XS PT Controls Optional liquid ...

Page 141: ... only for legal reasons as a PDF file file name License txt PDF on the CD supplied with this manual The complete license agreements are also stored as a text file file name License txt on the Hand held Base Unit You can access this file by connecting the base unit to a PC with the USB cable For detailed instruc tions on how to do this see the Operator s Manual of the Handheld Base Unit Everyone is...

Page 142: ...at Roche Care Center Telephone region of Montréal 450 686 7050 1 877 273 3433 toll free In Canada the CoaguChek XS Pro system is manufactured for and distributed by Roche Diagnostics 201 Boul Armand Frappier Laval Québec Canada H7V 4A2 1 888 262 9515 www rochecanada com 12 Warranty The statutory guarantee provisions on rights in consumer goods sales in the country of purchase shall apply ...

Page 143: ... with the structure of your barcode content Always make sure that the entire barcode is covered by the red laser beam when scanning WARNING Risk of barcode read errors If a barcode is read incorrectly this may lead to patient misidentification and therefore to inappropriate therapy decisions To minimize the risk of barcode read errors the facility must ensure that the barcode used is of adequate s...

Page 144: ...can 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 Plus 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 Caret This mask character denote...

Page 145: ...e barcode symbology 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 WARNING Avoidance of incorrect EAN 13 and Interleaved 2 5 barcode readings EAN 13 and Interleaved 2 5 barcodes although widely used are not recommended for patient operator bar codes If an EAN 13 or Interleaved 2 5...

Page 146: ...A Appendix 146 Codabar Code 39 Code 93 Code 128 EAN 13 Interleaved 2 5 ...

Page 147: ...g a test to check that the test is being performed according to the recom mended procedures He she then evaluates the perform ance and passes or fails the operator This assessment is saved together with the test result and any desired com ments Observed Test Sequence options can only be config ured using a DMS The availability of electronic config uration options will thus vary according to the da...

Page 148: ...erator ID which is also your observer ID in this case 5 Enter the optional password 6 After you enter your password touch to log in The Pat Test OTS menu is displayed again The Patient Test button is now active 7 Hand the meter to the operator who can now per form the patient test under supervision Observer 09 15 am 04 19 2012 Ann Casey Alan Smithee Scan Pat Test OTS 09 15 am 04 19 2012 Observer L...

Page 149: ...ormance by touching Pass or Fail 6 Assess the test result by touching Accept or Reject 7 Touch to add a comment 8 Touch to return to the Pat Test OTS screen The OTS information is saved together with the test result Pat Test OTS 09 15 am 04 19 2012 Observer Login Patient Test OTS enabled Remove 09 15 am 04 19 2012 Observer Login Observer ALAN SMITHEE please log in to proceed Otherwise the OTS test...

Page 150: ...B Appendix 150 This page intentionally left blank ...

Page 151: ... Adding 92 Computer 52 Connection 52 Contrast 37 Control solution Applying 102 Code chip 100 Preparing 96 Custom range 64 65 D Data transfer 111 Date 42 Disinfection 121 133 Display Icons 23 24 Display format 44 Disposal 15 26 76 93 104 E Error messages 135 F Fingertip 88 I Icons Drop 87 Dropper 101 Hourglass 87 101 Identification plate 4 Overview 23 24 Packaging 4 ID Setup 54 62 Overview 54 Infra...

Page 152: ...ange 64 QC Settings 63 68 Quality Control Lockout 67 82 Memory 109 Preparing 96 Result 103 R Relative humidity 20 139 Reset button 22 Result confirmation 39 91 Review Results 105 118 Data transfer 111 S Safety Protection against infection 14 User qualification 14 Scan button 80 85 Screen 37 45 Setup Admin password 56 59 Auto Off 50 Beeper 48 Computer 52 Contrast 37 Date 42 Display format 44 ID Set...

Page 153: ...t principle 11 Test result patient test 90 Test result quality control 103 Test strip Icon 86 99 Inserting 86 99 Test strip guide cover 127 Thromboplastin 11 Time 43 Troubleshooting 135 U Unit test result 90 Units of measure 38 V Voltage 20 W Warranty 142 ...

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Page 155: ......

Page 156: ...950540001 02 2015 12 EN CAN ACCU CHEK COAGUCHEK and SAFE T PRO are trademarks of Roche Roche Diagnostics GmbH Sandhofer Strasse 116 68305 Mannheim Germany www roche com www coaguchek com www poc roche com ...

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