Roche CoaguChek Pro II, Operator'S Manual

Page 1: ...CoaguChek Pro II Operator s Manual...

Page 2: ...0 8251398001 03 2020 10 EN CAN CoaguChek Pro II Operator s Manual Publication version 3 0 Software version 04 05...

Page 3: ...date valid for SW04 05 xx License information 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 an...

Page 4: ...r s Manual Trademarks ACCU CHEK COAGUCHEK and SAFE T PRO are trademarks of Roche All other trademarks are the property of their respective owners Approvals The Wi Fi CERTIFIED Logo is a certification...

Page 5: ...is product Temperature limitation Store at Admissible humidity Store at Use by Manufacturer Date of manufacture LOT Batch code Lot number Catalog number Global Trade Item Number SN Serial Number IVD I...

Page 6: ...h UL 61010A 1 02 and CAN CSA C22 2 No 61010 1 04 12V 1 25A Power supply connection On meters with WLAN capability This device complies with Part 15 of the FCC Rules and with RSS 210 of Industry Canada...

Page 7: ...Meter Setup 45 3 1 Display of screen elements 45 3 2 Settings summary 47 3 3 Screen setup 52 3 4 Options setup 62 3 5 ID setup 76 3 6 QC Settings setup 85 3 7 Diagnostics 99 4 Testing a Blood Sample 1...

Page 8: ...up 165 8 6 Cleaning the scanner window 167 9 Troubleshooting 169 9 1 Status Error messages 169 9 2 Shut down restart reset meter 176 10 General Product Specifications 179 10 1 Technical data 179 10 2...

Page 9: ...st Sequence screen u To log on as an operator during OTS 193 SW04 05 xx Icons added Server certificate status and Reset u 1 4 Buttons and icons overview 31 Improved data retention options u To configu...

Page 10: ...Pro II Operator s Manual More detailed description of Database option u To configure the database 72 More detailed description of TLS configuration u To connect to the computer 69 u To connect to the...

Page 11: ...he first time You must configure the CoaguChek Pro II meter according to your needs before initial use Refer to Chapter 3 Meter Setup Be sure to read the Important safety instructions and additional i...

Page 12: ...lict of information the package insert included with the CoaguChek test strips shall prevail What can the system do for you The CoaguChek Pro II system makes coagulation testing easy You only need to...

Page 13: ...ilable separately or via wireless communication WLAN The CoaguChek Pro II meter supports data exchange via the POCT1 A standard Data management systems may have the ability to expand the security feat...

Page 14: ...the following items CoaguChek Pro II meter Additional test strip guide cover spare part Battery compartment cover Universal Battery Pack Power supply Starshaped screwdriver Operator s Manual printed v...

Page 15: ...15 CoaguChek Pro II Operator s Manual u Related topics 3 4 Options setup 62 1 Introduction 1...

Page 16: ...ader to related safety information These symbols and signal words are used for specific hazards WARNING Warning r indicates a hazardous situation that if not avoided could result in death or serious i...

Page 17: ...screen illustrations indicates that some screens have been skipped in these illustrations Safety information Operator qualification r Only trained healthcare professionals may operate the CoaguChek P...

Page 18: ...re capable of transmitting blood borne pathogens between patients and between patients and healthcare professionals r Use gloves Wear a new pair of clean gloves for testing each patient and control te...

Page 19: ...iately with water r Follow all health and safety regulations in force locally WARNING Avoidance of electrical shock fire and explosions r Only use Roche Diagnostics original accessories cables power s...

Page 20: ...before thermal disinfection General care NOTICE Clean the meter only with the solutions recommended Using other solutions may result in incorrect operation and possible system failure Do not let clea...

Page 21: ...ack as this could cause an internal short circuit that leads to overheating r Do not place either the battery pack or the CoaguChek Pro II meter on or in heating appliances such as a microwave convent...

Page 22: ...g the battery pack When the Battery Low warning is displayed the meter must be returned as soon as possible to the Handheld Base Unit or connected to the power adapter for recharging When the battery...

Page 23: ...d access If this meter 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 Internet...

Page 24: ...unauthorized access by means of a strong password management Observe your own facility guidelines on password management where available or apply the following rules Characteristics of strong passwor...

Page 25: ...Radiofrequency radiation exposure information Glossary FCC stands for Federal Communications Commission USA RF stands for radio frequency RSS stands for Radio Standards Specification Canada WLAN stan...

Page 26: ...sure that wireless devices work together and support secure connections The CoaguChek Pro II system complies with FCC radiation exposure limits set forth for an uncontrolled environment This equipment...

Page 27: ...ent does cause harmful interference to radio or television reception which can be determined by powering the equipment off and on the user is encouraged to try to correct the interference by one or mo...

Page 28: ...er 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...

Page 29: ...29 CoaguChek Pro II Operator s Manual 1 3 Overview of the meter elements E F G H I J A B C D E 1 Introduction 1...

Page 30: ...pack when the meter is docked in the optional Handheld Base Unit C Test strip guide cover Remove this cover to clean the test strip guide if it has become soiled e g with blood H Code chip slot shown...

Page 31: ...card setting Return to previous menu Decrease increase the value displayed Scroll through lists that are too long to be displayed all at once Inactive button Value cannot be further decreased increase...

Page 32: ...e display Insert the test strip code chip QC Insert the QC code chip QC Automatic quality control completed successfully Q Results are displayed as a Quick percentage value SEC Results are displayed i...

Page 33: ...segment remaining you may not be able to finish performing a test Recharge as soon as possible When the power supply icon is displayed the meter is connected to the power supply adapter or the HBU Cha...

Page 34: ...ion passed Last synchronization failed An OTS request is pending Cleaning Disinfection is necessary Patient test result is out of normal patient test range Approved indicates server or root CA certifi...

Page 35: ...overnight To save power the CoaguChek Pro II meter has an automatic power off function auto off The default setting is 5 minutes of inactivity e g no screen touches It is possible to customize the au...

Page 36: ...r Dispose of used battery packs in an environmentally responsible manner in accordance with applicable local regulations and directives See Infection by a potentially biohazardous instrument u Dispos...

Page 37: ...er for the first time perform the following steps 1 Install the battery pack 2 Connect the power adapter to charge the battery pack 3 Set the current date and time 4 Enter your chosen settings languag...

Page 38: ...he power adapter the icon is displayed This icon shows that power is available and the meter can be charged if necessary To start the charging process immediately put the meter into standby mode by pr...

Page 39: ...the kit or another appropriate starshaped screwdriver e g Torx size T5 loosen the screws on the battery compartment cover until they are protruding about 4 5 mm 2 10 in 2 Hold the battery pack in you...

Page 40: ...groove on the battery compartment rim 6 Tighten all four screws until snug do not overtighten After inserting a new battery pack the meter powers on automatically The Roche logo is displayed If the m...

Page 41: ...le local regulations and directives and your facility s guidelines on the disposal of electronic waste equipment If a battery pack is already installed make sure that the meter is shut down to prevent...

Page 42: ...ther appropriate starshaped screwdriver e g Torx size T5 remove the four screws holding the battery compartment cover in place 4 Remove the battery compartment cover from the meter The battery pack no...

Page 43: ...ocking it in the Handheld Base Unit 3 To power the meter off after use press the button for approximately 1 second r To check the software version 1 After displaying the Roche logo the meter briefly d...

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Page 45: ...r powering on for the first time or because the battery pack was 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 t...

Page 46: ...tomatically enter the Setup mode e g after the battery pack was replaced you can open the Setup Menu from the Main Menu 1 Touch Setup to open the meter settings 2 Select the relevant group of settings...

Page 47: ...47 CoaguChek Pro II Operator s Manual 3 2 Settings summary The diagram below shows all of the setup areas that can be accessed on the meter 3 Meter Setup 3...

Page 48: ...er Activation PT PT aPTT Result Confirmation Enable Disable Language Selection e tina Dansk Deutsch English Espa ol Fran ais Italiano Nederlands Norsk Portugu s Suomi Svenska Date Time Date 01 01 2015...

Page 49: ...h with am pm 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 Computer...

Page 50: ...ve Scan Only Hidden list Patient No Optional Required Scan Only Hidden list QC Settings QC Range PT Default Range aPTT Custom Range Lockouts Operator Lockout only if the Operator option is set to Acti...

Page 51: ...ttings Time of day First day of week STAT Test Config Enable Disable Quantity 2 Level QC Yes No Scan QC Material Optional Scan Only Diagnostics General Software Hardware Memory Usage Error History Wir...

Page 52: ...ouch 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 4 Touch or to change t...

Page 53: ...esult is displayed This setting only applies to PT test results Regardless of the settings chosen for PT aPTT is always displayed in seconds 1 From the Main Menu touch Setup to open the meter settings...

Page 54: ...eter Additional test parameters can be activated on the meter For doing so you need the corresponding CoaguChek Test Strips with the matching code chip at hand Available parameters are country specifi...

Page 55: ...tion menu If the Parameter Activation button is grayed out all available parameters have already been activated on this meter A parameter that has already been activated on the meter remains activated...

Page 56: ...3 From the Screen menu touch Result Confirmation 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 disp...

Page 57: ...Dansk Deutsch English Espa ol Fran ais Italiano Nederlands Norsk Portugu s Suomi Svenska 4 Touch or to display the language of choice on the screen If the arrow is just an outline you have reached the...

Page 58: ...hoice Both Date and Time display formats are controlled by the Format options you select see Setting the display options for date and time in this chapter Options shown in the Date and Time menus may...

Page 59: ...wering the meter on you must touch to complete the first date setting 7 Touch to return to the Screen menu r To set the time When you power on the meter for the first time or after a long period witho...

Page 60: ...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 r To set th...

Page 61: ...15 Date MM DD YYYY Month Day Year e g 05 29 2015 Date YYYY MM DD Year Month Day e g 2015 05 29 Time 24H or 12H 5 Touch the button with the display format of choice for date and time Your selection is...

Page 62: ...on of the CoaguChek Pro II meter You can display stored results chronologically by date and time or by person based on the Patient ID 1 From the Main Menu touch Setup to open the meter settings 2 From...

Page 63: ...nformation visually and alert you to special circumstances with a Beeper The meter always beeps when it is switched on When the Beeper function is enabled the meter beeps once when it detects a test s...

Page 64: ...owing options for the Beeper Off Low Medium High 5 You may select from the following options for the Key Click On Off 6 Touch the button with the desired setting for the Beeper then touch the button w...

Page 65: ...om the Main Menu touch Setup to open the meter settings 2 From the Setup Menu touch Options 3 From the Options menu touch Auto Off If the meter is connected to the power adapter or the Handheld Base U...

Page 66: ...ion In the Connection menu you can configure the data exchange with external devices The meter can be connected to a computer DMS only or to a printer only or to both a computer DMS and a printer In a...

Page 67: ...t and related meta information e g date time comments will appear as plain text in your PC application Ensure that your environment for reading QR codes QR code reader operating system text processing...

Page 68: ...e test result data will be uploaded note the URL will be provided by your specialized service provider Use 123 to switch to input of numbers Use ABC to switch back to input of text Use to backspace an...

Page 69: ...o the previous screen r To connect to the computer The CoaguChek Pro II meter can connect with a computer or host system running appropriate software that is a DMS must be installed To use this connec...

Page 70: ...r 1 From the Connection menu touch Computer or Computer Printer Your selection is now highlighted Touch To enable the connection option 66 If you are using a DMS from the TLS screen you may select on...

Page 71: ...if you want to activate both functions at the same time To use the printing feature you need an optional infrared printer 1 From the Connection menu touch Printer or Computer Printer Your selection i...

Page 72: ...a language other than English With the exception of information you have entered such as patient ID and name operator ID comments the printout will be in English See To select a language 56 r To conf...

Page 73: ...You may select from the following options Result Retention Delete Database 4 Touch the button to select the database option of your choice Your selection is now highlighted If you selected Result Rete...

Page 74: ...meter can be set to display a screen that allows the operator to select the test parameter to be used Otherwise the meter will determine the test parameter by reading the test strip barcode informati...

Page 75: ...r Selection 5 Touch Enable to display the parameter selection screen prior to each test or touch Disable to have the meter select the parameter by reading the test strip information 6 Touch to save th...

Page 76: ...rsons 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...

Page 77: ...de scanner on the side of the meter For more information on working with operator and patient ID barcodes see Data handling u 7 1 Data handling 147 The buttons in the ID Setup menu show what the curre...

Page 78: ...s Connection to a computer or a printer ID Setup the entire area QC Settings the entire area Diagnostics Software Hardware Memory Wireless Setup When you enter an Admin ID this ID will have to be ente...

Page 79: ...stake 8 Touch to save this setting or touch to exit this menu without saving any changes The display automatically returns to the previous screen 9 Enter the Admin ID again the keypad is automatically...

Page 80: ...yed on the screen enter the current Admin ID The ID Setup menu is displayed The Admin button is highlighted which means an Admin ID is active 4 Touch Admin 5 Using the keypad displayed on the screen e...

Page 81: ...erefore deactivated The Admin button is no longer highlighted Operator ID If you want to create a list of Operator IDs from which you can select an operator additional software a data management syste...

Page 82: ...Setup Menu touch ID Setup 3 From the ID Setup menu touch Operator 4 Touch the button with the setting of choice for setting up the Operator login Your selection is now highlighted 5 Touch to save thi...

Page 83: ...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 r To activate a patient ID 1 From the Main Menu...

Page 84: ...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 th...

Page 85: ...re two options Default Range The meter displays the QC Range provided by Roche Diagnostics in the code chip Custom Range The option Custom Range lets the user define their own QC Range within the defa...

Page 86: ...e test for one level If disabled the meter returns to the Main Menu once one of the two levels has successfully been tested Scan QC Material The barcode scanner of the CoaguChek Pro II meter can be us...

Page 87: ...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...

Page 88: ...R 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 percentage deviatio...

Page 89: ...ut 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 operator lists QC Lockout is di...

Page 90: ...e before the counter reaches the limit by performing a quality control test The counter will be reset once the quality control test has successfully been finished r To set a QC quality control Lockout...

Page 91: ...to display the interval of choice on the screen For additional setup options of date based intervals Daily Weekly Monthly see QC Interval Settings 94 9 Touch the button to select the interval of your...

Page 92: ...revious screen Operator Lockout Optional liquid quality controls can be used to ensure that an operator is performing tests properly on the CoaguChek Pro II meter The Operator Lockout function constra...

Page 93: ...ing 147 If you are not working with a DMS only the QC Lockout is available See QC quality control Lockout 89 5 Select the interval of choice in which the mandatory quality control tests must be perfor...

Page 94: ...n QC Interval Settings For all lockouts based on date intervals Daily Weekly Monthly the time of occurrence can be set and for weekly lockouts also a preferred day of the week r To set the QC interval...

Page 95: ...quality and accurate measurements In emergency situations however it may be necessary to perform a test without delay To override an active lockout 3 you can allow STAT Tests STAT Short TurnAround Ti...

Page 96: ...o enable disable the STAT test option 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 Lockouts 4 From the Lockouts...

Page 97: ...settings 2 From the Setup Menu touch QC Settings 3 From the QC Settings menu touch 2 Level QC 4 Touch Yes to automatically start the test for the second level once the test for one level has been fin...

Page 98: ...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 Scan QC Material 4 Touch Optional to allow manual selection of a QC lot...

Page 99: ...gnostics screens shown here are for illustration purposes only The Information shown on your meter may differ r To display the diagnostics screens 1 From the Main Menu touch Setup to open the meter se...

Page 100: ...100 CoaguChek Pro II Operator s Manual 4 Use and to toggle between the Wireless Setup screens 5 In the diagnostics screen touch to return to the previous menu 3 Meter Setup 3...

Page 101: ...on ball and alcohol wipe u What can the system do for you 12 Always close the strip container immediately after removing a test strip operate the meter at an ambient temperature between 12 C and 32 C...

Page 102: ...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 touch or remove the test strip during a test wait more...

Page 103: ...isinfect the blood collection site on the finger Dry thoroughly Have the patient let that arm hang down by his or her side before lancing a finger Massage the finger from its base Use these techniques...

Page 104: ...N r Discard the first four drops of blood collected within the first 10 seconds Then immediately apply one drop of blood at least 8 L directly onto the target area of the test strip Ensure that no air...

Page 105: ...Test strip code chip The code chip provides the meter with important information that it needs to perform the coagulation test The chip contains information about the test method the lot number and th...

Page 106: ...sting with test strips taken from a new pack Protect the code chip from moisture and equipment that produces magnetic fields r To insert the code chip 1 Remove the old code chip if one is inserted in...

Page 107: ...ower on the meter 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 You can also power on the meter directly by i...

Page 108: ...perator ID field The scanner turns off after 10 seconds if a barcode is not scanned 6 If the function Operator ID is active with operator list wait until the operator list is displayed 7 Select the op...

Page 109: ...mpleted or another operator wants to perform additional tests touch Logout to log out this button is available only when the Operator ID is activated The meter returns to the display of the operator p...

Page 110: ...es as described in Chapter 3 Meter Setup To set the date 58 To set the time 59 3 If a lockout Operator or QC Lockout is displayed instead of the Patient Test button you must run a liquid quality contr...

Page 111: ...ient ID option was chosen as either Optional or Required when the meter was set up you are prompted to enter a Patient ID See Patient ID 83 If Required enter the Patient ID then touch to move to the n...

Page 112: ...ee 7 1 Data handling 147 10 Alternatively the Patient ID can also be entered using the built in barcode scanner 7 8 Touch Scan and scan the patient barcode from a distance of approx 10 20 cm 4 8 inche...

Page 113: ...st strips and may lead to error messages Therefore always close the test strip container immediately after removing a test strip 13 Hold the test strip so the lettering with the test name is facing up...

Page 114: ...ds Otherwise you will receive an error message When the test is running no operator action is required The display dims to save energy r To apply blood from the fingertip WARNING Use only a lancing de...

Page 115: ...til the flashing blood drop icon is no longer displayed and the meter beeps provided the beeper is enabled Apply the blood drop to the test strip within 15 seconds of lancing the fingertip Applying bl...

Page 116: ...est starts Do not add more blood sample To avoid error messages do not touch the test strip until the result is displayed The meter performs an automatic quality control test on the test strip before...

Page 117: ...the message persists perform a hematocrit check If a is displayed along with the result This may occur if the test result is out of normal range Touch the icon to display the Out Of Normal Range info...

Page 118: ...comments You can add up to three comments to a test result Comments can provide for example additional information about the test conditions or the patient A comment may be up to 20 characters in leng...

Page 119: ...QR code display function is activated Otherwise it is not displayed See To enable disable the QR Code display 67 1 Touch to display the result as QR code 2 Touch to return to the standard result displ...

Page 120: ...er 155 r To perform a STAT test STAT tests are a limited number of tests that can be performed in emergency situations If the meter is configured to perform STAT tests you have the option of performin...

Page 121: ...ed 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 available again in case of a new lockout...

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Page 123: ...to assist you in meeting regulatory compliance requirements at your facility To perform an optional liquid quality control test using control solutions you need CoaguChek Pro II meter The test strip c...

Page 124: ...trip 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 3 Make sure the bottle of freeze dried lyophili...

Page 125: ...the dropper by the stem do not squeeze the bulb of the dropper while cutting the tip 7 Apply gentle pressure to the reservoir to transfer the entire contents of the dropper to the bottle Make sure th...

Page 126: ...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...

Page 127: ...Menu is displayed or log on as described in To power on the meter 107 4 Check the battery level If the battery icon turns red one bar remaining there may not be enough power remaining for another test...

Page 128: ...ernal influences such as humidity may deteriorate the test strips and may lead to error messages Therefore always close the test strip container immediately after removing a test strip 10 Hold the tes...

Page 129: ...the same control solutions at any time 13 Select the code stored for your current control solution or touch New Code to use a new control solution When entering or selecting a code manually make sure...

Page 130: ...that it is a control solution code chip 16 If performing more than one level select the level for this measurement The hourglass icon shows that the test strip is warming up When the warming up proces...

Page 131: ...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...

Page 132: ...from the pick list if configured or 21 Touch Custom to enter your own custom comment Use the keypad as with login to enter your comment A comment may be up to 20 characters in length 22 Once you have...

Page 133: ...with 8 2 Cleaning and disinfecting the meter 155 27 CAUTION Dispose of controls and used test strips from control testing in accordance with the disposal policy of your facility The control solution...

Page 134: ...supplied are treated in the same manner as regular patient samples Proficiency testing provides another means of verifying that your technique reagents system and testing performance are as they shoul...

Page 135: ...stead of blood from a patient To perform a proficiency test you need the following The information of at least one code chip for test strips must be stored in the meter and must match the lot number o...

Page 136: ...played or log on as described in To power on the meter 107 4 Check the battery level If the battery icon turns red one bar remaining there may not be enough power remaining for another test If there a...

Page 137: ...xternal influences such as humidity may deteriorate the test strips and may lead to error messages Therefore always close the test strip container immediately after removing a test strip 9 Hold the te...

Page 138: ...mple The dropper icon flashes to indicate that the meter is ready to perform the test and is waiting for the sample to be applied A countdown begins at the same time You must apply the sample within t...

Page 139: ...comments touch The test result is automatically saved to memory After the test result is displayed touch You will be prompted to remove the strip 14 CAUTION Dispose of used test strips from proficien...

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Page 141: ...n 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 the memory is full when you perform a test the oldest result is aut...

Page 142: ...r on by pressing 3 Wait until the main menu is displayed 4 Touch Review Results 5 Select the type of results you want to view Display Patient Result memory Display QC Result memory 6 Select the test p...

Page 143: ...ient only Printer icon The printer icon only appears if the printer function is activated Otherwise it is not displayed QR Code icon The QR code icon only appears if the QR code display is activated O...

Page 144: ...you cannot filter a list by test parameters The QR code icon only appears if the QR code display function is activated Otherwise it is not displayed 4 Touch to display the result as QR code 5 Touch to...

Page 145: ...145 CoaguChek Pro II Operator s Manual 1 Touch or to scroll to the entry of choice on the screen 2 Touch the entry you want to open The entry is displayed 6 Review Results Memory 6...

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Page 147: ...l meter setup can be performed for one or more meters quickly and conveniently Transferring all stored test results with the corresponding Patient ID Operator ID and comments from the meter to the DMS...

Page 148: ...nit 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 Depending...

Page 149: ...cts 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 Operator is activated a list is available but set to hidden The...

Page 150: ...f Patient IDs is always shown when starting 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 eith...

Page 151: ...and patient IDs apply the following rules Patient IDs can consist of up to 20 alphanumeric characters with specified minimum and maximum lengths Operator IDs can consist of up to 20 alphanumeric char...

Page 152: ...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 Patient result comments QC results comment Asymptomatic Acceptable Con...

Page 153: ...Store the system and test strips in the same environment in which they are used Do not store the meter in direct sunlight or under extreme temperature conditions Observe the limits for temperature an...

Page 154: ...See Battery pack for the risks associated with damaged battery packs and disposal information Package the battery pack for shipping so that it cannot move around in the packaging Also observe any othe...

Page 155: ...tween cleaning and disinfecting Cleaning 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 diseasecau...

Page 156: ...product contains the approved active ingredients and is licensed for use in Canada The use of Sani Cloth Plus Germicidal Disposable Wipes is not recommended NOTICE Damage to the instrument r Use only...

Page 157: ...157 CoaguChek Pro II Operator s Manual For technical assistance or questions on cleaning and disinfecting please contact Roche Care Center at 1 877 273 3433 8 Maintenance and Care 8...

Page 158: ...k 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 a...

Page 159: ...the meter 2 Dry the exterior After cleaning the housing wipe away any residual moisture and fluids with a dry lint free cloth 3 Disinfect the exterior Take a fresh Super Sani Cloth Germicidal Disposab...

Page 160: ...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 seen anywhere on the meter at...

Page 161: ...ent r Use only products containing the approved active ingredients Do not use any other cleaning or disinfecting solutions as this could result in damage to the system components u Approved cleaning a...

Page 162: ...le Wipe Remove any excess moisture from the cloth Do not clean beyond the white area inside the meter After cleaning carefully dry the test strip guide with a dry lint free cloth 4 Disinfect the test...

Page 163: ...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 strip guide sit wet for a contact...

Page 164: ...completion of cleaning and disinfecting Ensure that the test strip guide and cover are completely dry before assembling them 7 WARNING Re attach the test strip guide cover to the housing Make sure tha...

Page 165: ...e per month Approved cleaning agents Test strip guide Use a cotton swab slightly dampened with water NOTICE r Do not use any other cleaning solutions as this could result in damage to the system compo...

Page 166: ...he meter Ensure the swab is only damp not wet Wipe away residual moisture and fluids Ensure the swab is only damp not wet Wipe away residual moisture and fluids Carefully wipe the test strip guide dry...

Page 167: ...167 CoaguChek Pro II Operator s Manual 8 6 Cleaning the scanner window The scanner window should be cleaned periodically Use a clean dry cloth to wipe the scanner window 8 Maintenance and Care 8...

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Page 169: ...on the display of the meter These messages are marked with an icon either for a status message or for an error message All messages displayed by the system are accompanied by a description of the err...

Page 170: ...ror message Touch to exit this message Perform the suggested step s to solve the problem Power the meter off and remove the test strip Repeat the measurement using a new test strip and blood taken fro...

Page 171: ...age Perform the suggested step s to solve the problem Dosing refers to the procedure of applying the blood sample to the test strip Dosing Error indicates that an insufficient sample volume was detect...

Page 172: ...r Do not touch or remove the test strip when a test is in progress Note on error E 406 The CoaguChek PT Test strip may be used for patients under a combination therapy of oral anticoagulants plus hepa...

Page 173: ...ubes that contain anticoagulants Error History To check the error history of the CoaguChek Pro II meter you can scroll through the errors on the Error History screen via Main Menu Setup Diagnostics u...

Page 174: ...own 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 t...

Page 175: ...mal range Touch the icon to display the Out Of Normal Range information screen When interpreting results refer to the detailed information on limitations and interferences included in the limitations...

Page 176: ...shut down Use meter shutdown when you want to remove or replace the battery pack See To remove the battery pack 41 r To shut down meter connected to the external power supply or HBU 1 To restart the m...

Page 177: ...er will start up again The meter powers off and on again The Roche logo is displayed If the Roche logo does not appear within 60 seconds place the meter in the Handheld Base Unit for a minimum of 15 m...

Page 178: ...of your facility via the Handheld Base Unit or if working wirelessly wait at least ten minutes for the next WLAN synchronization before performing any further tests Even if your configuration does no...

Page 179: ...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 Touchscreen and barcode scanner Battery operation Universal Battery P...

Page 180: ...nditions Temperature range Meter without battery pack 25 C to 70 C 13 F to 158 F Temperature range Meter with battery pack contained in the kit a 10 C to 70 C 14 F to 158 F Relative humidity 10 to 85...

Page 181: ...through Roche Diagnostics Contact your local Roche Diagnostics representative Product limitations Read the information in the package insert supplied with the reagents and solutions for detailed produ...

Page 182: ...nd other modifications to the meter may only be performed by persons authorized by Roche Diagnostics Contact Roche For all questions about the CoaguChek Pro II system that are not answered in this man...

Page 183: ...183 CoaguChek Pro II Operator s Manual 11 Warranty The statutory guarantee provisions on rights in consumer goods sales in the country of purchase shall apply 11 Warranty 11...

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Page 185: ...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...

Page 186: ...eous decoding In addition every user must carry out a plausibility check on all data scanned into and displayed by the instrument To reduce the probability of the barcode being misread it is strongly...

Page 187: ...rposes 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 When creati...

Page 188: ...0 16 mm linear barcodes 0 20 mm 2D barcodes Codabar Code 39 Code 93 Code 128 EAN 13 Interleaved 2 5 without checksum Interleaved 2 5 with checksum RSS GS1 DataBar Limited Roche Diagnostics Aztec Roch...

Page 189: ...acters in 2D barcodes The 2D barcode scanner is able to read characters from the following unicode ranges Basic Latin 0021 007E Latin 1 Supplement 00A1 00FF Latin Extended A 0100 017F The 2D barcode s...

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Page 191: ...r 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 togeth...

Page 192: ...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...

Page 193: ...To perform tasks as an observer during OTS 1 Touch to log in again 2 After you enter your password touch to proceed with the assessment 3 Assess the operator s performance by touching Pass or Fail 4 A...

Page 194: ...194 CoaguChek Pro II Operator s Manual 7 Touch to return to the Main Menu The OTS information is saved together with the test result 13 Appendix B 13...

Page 195: ...n WLAN registration see addendum WLAN registration information Addendum to the Operator s Manual for the CoaguChek Pro II meter at www poc roche com select the Products and Point of Care Background Th...

Page 196: ...r multi media applications the meter s bandwidth consumption is minimal If the WLAN that the CoaguChek Pro II meter seeks to connect to is degraded the meter design minimizes the impact on functionali...

Page 197: ...supports IEEE 802 11b and 802 11g It works seamlessly together with other Wi Fi certified transceivers It also implements the Wi Fi Protected Access WPA Enterprise and WPA Personal Wi Fi Protected Acc...

Page 198: ...nfigured with the new protocol As described above the CoaguChek Pro II meter supports the 802 11g standard This translates into the following RF specific performance claims The CoaguChek Pro II meter...

Page 199: ...of the access point s antennas and other topological properties of the space between WLAN device and AP Additionally dynamic control of the transmitting power of the access point may reduce the maxim...

Page 200: ...58 161 165 167 Interior test strip guide 165 Meter housing 158 Test strip guide 161 165 Coagulation process 114 Code chip 105 Inserting 106 Code number 106 Comments Adding 118 Computer 69 Connection 6...

Page 201: ...05 Measuring range 179 Memory Button 142 Patient Result 143 Quality Control 144 Meter Overview 29 Reset 177 O Observed Test Sequence OTS 191 192 Operating conditions 27 179 Operator Lockout 92 94 Logo...

Page 202: ...69 71 Contrast 52 Date 58 Display format 60 ID Setup 76 78 80 81 83 Language 56 Operator ID 81 Options 62 63 65 66 67 69 71 Parameter selection 74 Patient ID 83 Printer 71 QR code 67 Result confirmati...

Page 203: ...203 CoaguChek Pro II Operator s Manual U Unit test result 116 Units of measure 53 54 V Voltage 27 W Warranty 183 Wi Fi 26 WLAN 195 196 198...

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Page 206: ...arks of Roche Distributed in Canada by Roche Diagnostics 201 Boul Armand Frappier Laval Qu bec Canada H7V 4A2 Roche Diagnostics GmbH Sandhofer Strasse 116 68305 Mannheim Germany www rochecanada com ww...