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Roche CoaguCheck Pro II, Operator'S Manual

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Roche CoaguCheck Pro II Operator'S Manual Download Page 25

Introduction • 

1

25

The CoaguChek Pro II system complies with FCC radia-

tion exposure limits set forth for an uncontrolled environ-

ment. This equipment should be installed and operated 

with minimum distance of 20 cm (8 inches) between the 

radiator and your body.

This transmitter must not be co-located or operated in 

conjunction with any other antenna or transmitter. 

Changes or modifications made to this equipment not 

expressly approved by Roche Diagnostics may void the 

FCC authorization to operate this equipment.

This device complies with Part 15 of the FCC Rules and 

with RSS-210 of Industry Canada. Operation is subject to 

the following two conditions:

(1) this device may not cause harmful interference,

and

(2) this device must accept any interference received, 

including interference that may cause undesired opera-

tion.

Summary of Contents for CoaguCheck Pro II

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

Page 2: ...Revision History Manual version Revision date Changes Version 1 0 2015 11 New document Version 2 0 2015 11 Revised safety information on barcode handling minor changes ...

Page 3: ...0 7154879001 02 2015 11 EN CoaguChek Pro II Operator s Manual Version 2 0 ...

Page 4: ...ons contained herein No part of this document may be reproduced or transmitted in any form or by any means electronic or mechanical for any purpose without the express written permission of Roche Diagnostics Please send questions or comments about this manual to your local Roche representative ACCU CHEK COAGUCHEK and SAFE T PRO are trademarks of Roche All other trademarks are the property of their...

Page 5: ...notes in the instructions for use accompanying this product Temperature limitation Store at Use by Manufacturer Batch code Lot number Catalog number In vitro diagnostic medical device This product fulfills the requirements of the European Directive 98 79 EC on in vitro diagnostic medical devices Consult instructions for use The system fulfills the Canadian and U S safety requirements UL LISTED in ...

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Page 7: ... connectivity 23 Radiofrequency radiation exposure information 23 Operating conditions 27 Quality control 27 1 3 Overview of the meter elements 28 1 4 Buttons and icons overview 30 1 5 Power supply 33 2 Putting the Meter into Operation 35 2 1 Installing or replacing the battery pack 36 Removing the battery pack 37 Installing the battery pack 38 2 2 Powering the meter on and off 41 Checking the sof...

Page 8: ...d result from venous whole blood 96 4 2 Preparing to test 97 Test strip code chip 97 Inserting the code chip 98 Powering on the meter 99 4 3 Performing a test 102 Applying blood from the fingertip 108 Applying blood with a syringe 109 Accepting or rejecting a test result 112 Adding comments 113 Displaying the test result as QR code 114 Finishing the test 114 STAT tests 115 5 Control and Proficienc...

Page 9: ...disinfecting 149 When should the meter be cleaned and disinfected 149 What to clean and disinfect 149 8 3 Recommended cleaning disinfecting agents 151 8 4 Cleaning disinfecting the exterior meter housing 152 8 5 Cleaning disinfecting the test strip guide 153 8 6 Cleaning the scanner window 154 9 Troubleshooting 155 Additional information on error E 406 156 Errors and unusual behavior without error...

Page 10: ...characters in 2D barcodes 169 B Appendix 171 B 1 Supplement for Observed Test Sequence 171 Observed Test Sequence OTS 171 Using the OTS function 172 C Appendix 175 C 1 Option Wireless network WLAN 175 Background 176 Technical implementation 177 RF specific functionalities and effective performance claims 179 Index 183 ...

Page 11: ...ou must configure the CoaguChek Pro II meter accord ing to your needs before initial use Refer to chapter 3 Meter Setup Be sure to read the Important safety instructions and additional information section in this chapter before operating the system Before you use the meter for the first time after you have first inserted the battery pack you must set the date and time correctly to allow you to per...

Page 12: ...h 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 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 Depending on which test parameter is selected the meter disp...

Page 13: ...eter supports data exchange via the POCT1A standard Data management systems may have the ability to expand the security features of the meter such as ena bling operator lockouts Data management systems may also enable data transfer from a HIS and or to a LIS Refer to the manuals of the Handheld Base Unit and of your DMS for technical details Test principle The CoaguChek Tests contain desiccated re...

Page 14: ...ems CoaguChek Pro II meter Universal Battery Pack Power supply Operator s Manual printed version not shown here Manual CD ROM contains PDF files of the Opera tor s Manual in other languages not shown here Check for completeness and transport damage immedi ately after unpacking ...

Page 15: ...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 16: ...ustrations 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 17: ...ingle use lancing device for each patient Dispose of used lancets and needles in a sturdy sharps container with lid Dispose of used test strips according to your institu tion s infection control policy Follow all health and safety regulations in force locally WARNING Avoidance of electrical shock fire and explosions Only use Roche Diagnostics original accessories cables power supply units battery ...

Page 18: ...cluding cleaning disinfection and or sterilization is required before reuse recycling or disposal Dispose of the system or its components according to the appropriate local regulations Always remove the battery pack before thermal disinfection NOTICE Clean the meter only with the solutions recommended see page 147 Using other solutions may result in incorrect operation and possible system failure ...

Page 19: ...place either the battery pack or the CoaguChek Pro II 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 Hand held Base Unit Battery fluid or materials leaking from damaged battery packs can irritate your skin or cause burns due...

Page 20: ...nected to the power adapter for recharging Electromagnetic Interference The meter fulfills the IEC 61326 2 6 requirements for emitted interference and interference immunity Disposal of used battery packs Do not dispose of the battery pack with normal domestic waste Dispose of used battery packs in accordance with applicable local regulations and directives and your facility s guidelines on the dis...

Page 21: ...hat sensitive data transmitted via the POCT1 A interface is protected by appropriate security measures Ensure that the instrument is protected against unauthorized physical access and theft Do not use shared user or operator accounts on meter DMS and network Whether working in a wired or wireless environ ment use a strong password for user or operator accounts on the meter DMS and network Observe ...

Page 22: ... contain the user s account name or parts of the user s full name that exceed two consecutive characters Passwords should be at least eight characters in length Passwords should contain characters from the following three categories English uppercase alphabetic characters A through Z English lowercase alphabetic characters a through z Numeric characters 0 through 9 Examples of weak passwords uhxwz...

Page 23: ... be configured by the system administrator Observe the guidelines of your facility for using wireless local area network connec tions For a description of the CoaguChek Pro II meter s ability to connect to Wireless Local Area Networks WLAN Wi Fi see appendix C 1 Radiofrequency radiation exposure information Glossary FCC stands for Federal Communications Commission USA RF stands for radio frequency...

Page 24: ...could be near or at the same frequency and cause interference Roche Diagnostics supports industry wireless standards and recommends using products that have Wi Fi certifica tion This certification tests products to the 802 11 industry standards for basic connectivity security authentication Quality of Service QoS interoperability and reliability The Wi Fi CERTIFIED logo is an assurance that the Wi...

Page 25: ...ed in conjunction with any other antenna or transmitter Changes or modifications made to this equipment not expressly approved by Roche Diagnostics may void the FCC authorization to operate this equipment This device complies with Part 15 of the FCC Rules and with RSS 210 of Industry Canada Operation is subject to the following two conditions 1 this device may not cause harmful interference and 2 ...

Page 26: ...nstruc tions may cause harmful interference to radio communi cations However there is no guarantee that interference will not occur in a particular installation If this equipment 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 more of the following measu...

Page 27: ... free surface or hold it so it is roughly horizontal Quality control The meter has a number of built in quality control functions A check of the electronic components and 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 An onboard quality c...

Page 28: ...28 1 3 Overview of the meter elements C D F H I G J B A E E ...

Page 29: ...nsert the test strip here E Barcode scanner The integrated barcode scanner can scan operator patient and QC sample IDs into the meter F Battery compartment cover Remove to insert the battery pack G Charging terminals Used for power supply and or charging the battery pack when the meter is docked in the optional Handheld Base Unit H Code chip slot shown with code chip Insert the code chip here I Co...

Page 30: ...g Go to Main Menu OK save setting Cancel discard 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 increased or End of list in this direction is reached List of tests of a specific patient Print after test result or from memory Display test result as QR code Add ...

Page 31: ...in the chosen unit of measure is below the measuring range Quality control Result is above the specified range Quality control Result is below the specified range Battery status When the battery pack is fully charged all segments are lit Individual segments disappear one by one as the battery pack becomes weaker When there is only one segment remaining the icon is displayed in red When there is no...

Page 32: ...or message or a warning see Chapter 9 Troubleshooting Lockout one or more parameters are locked Button Icon Meaning QC Button Icon Meaning Communication is taking place via the infrared interface If displayed in the status bar communication is taking place via WLAN If displayed on the Patient Test button connectivity lockout only STAT testing possible An OTS request is pending Cleaning Disinfectio...

Page 33: ...gs if the power goes out To save power the CoaguChek Pro II meter has an auto matic power off function auto off The default setting is 5 minutes of inactivity e g no screen touches It is possible to customize the auto off function via your Setup selection refer to Auto Off on page 62 When the meter powers itself off all results are automat ically saved to memory The power adapter also serves as a ...

Page 34: ...eplacing the battery pack insert the new battery pack within 24 hours of removing the old one Otherwise you may need to re enter date and time Main Menu 09 15 am 05 29 2015 Control Test Review Results Setup Patient Test Dispose of used battery packs in an environmentally responsible manner in accordance with applicable local regulations and directives See Infection by a potentially biohazardous in...

Page 35: ...efore using the meter for the first time perform the fol lowing 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 language unit of measure user administration if applicable etc ...

Page 36: ... two hours before testing Please note that the battery pack will only reach full capacity once it has been fully emptied and charged several times Whenever the meter is placed on an active Handheld Base Unit or powered by the power adapter the icon is displayed This icon shows that power is availa ble and the meter can be charged if necessary Make sure that the permitted temperature range for char...

Page 37: ...ng the battery compartment cover in place 4 Remove the battery compartment cover from the meter The battery pack now visible is connected to the meter by a plug 5 Carefully lift the battery pack and remove the plug connector Disposal of used battery packs Do not dispose of the battery pack with normal domestic waste Dispose of used battery packs in accordance with applicable local regulations and ...

Page 38: ...ck in your hand with the wires and the plug pinched between your thumb and index finger 3 Plug the connector plug into the socket 4 Place the battery pack inside the battery compart ment as shown above To position the battery pack correctly always align the ridges on the side of the battery pack with the ridges on the inside of the battery compartment ...

Page 39: ...ery compartment Make sure that the plug connector wires do not get pinched between meter and cover the protrusion on the battery compartment cover fits into the corresponding groove on the battery compartment rim 6 Tighten all four screws until snug do not over tighten ...

Page 40: ... short period of time the start screen should appear If the meter has been without power for too long it will show the date and time settings dialog and you have to re enter the date and time settings The screens for entering the date and the time appear 7 Enter the date and time After you have entered the correct information confirm each screen with After installing a new battery pack the meter s...

Page 41: ...imately 1 second Checking the software version After displaying 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 You can also power on the meter directly by inserting a test strip connecting t...

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Page 43: ...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 battery pack was 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 battery pack was removed from the meter for more than 10 mi...

Page 44: ... 2 Select the relevant group of settings see the Settings summary following this section Main Menu 09 15 am 05 29 2015 Control Test Review Results Setup Patient Test Setup Menu 09 15 am 05 29 2015 QC Settings ID Setup Diagnostics Options Screen ...

Page 45: ...ed on the meter Setup Screen Options ID Setup QC Settings Result Units Lockouts Beeper Operator Contrast QC Range Sort Admin Date Time Result Confirmation Parameter Selection Auto Off Language Selection Scan QC Material Connection Patient Diagnostics Software General Hardware Memory Usage Wireless Setup ...

Page 46: ... Result Confirmation Enable Disable Language Selection Dansk Deutsch English Español Français Italiano Nederlands Norsk Português Suomi Svenska Date Time Date 01 01 2015 Time 12 00 am Date formats DD MM YYYY 01 01 2015 MM DD YYYY 01 01 2015 YYYY MM DD 2015 01 01 Time formats 24 hour time format 24h 12 hour time format 12h with am pm ...

Page 47: ...ient 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 QR Code Off On Parameter Selection Enable Disable ID Setup Admin Administrator Blank Off Operator Operator List is optional Inactive Active Patient No Optional Required ...

Page 48: ...o Active and an operator list is available Off Weekly Monthly Every 3 months Every 6 months Yearly Number of levels QC Lockout New code Yes No Scheduled No Daily Weekly Monthly Number of hours Number of strips For each option except No Number of levels 1 2 STAT Test Config Enable Disable Quantity Scan QC Material Optional Scan Only Diagnostics General Software Hardware Memory Usage Wireless Setup ...

Page 49: ...rom 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 05 29 2015 Control Test Review Results Setup Patient Test Setup Menu 09 15 am 05 29 2015 QC Settings ID Setup Diagnostics Options Screen Screen 09 15...

Page 50: ...a blue background You can select either INR 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 Setup Menu 09 15 am 05 29 2015 QC Settings ID Setup Diagnostics Options Screen Scree...

Page 51: ... 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 display automatically returns to the previous screen Setup Menu 09 15 am 05 29 2015 QC Settings ID Setup Diagnostics Options Screen Screen 09 15 am 05 29 2015 Language Selection Result Confirmation Date Time Result Units Contrast Ma...

Page 52: ...nguage setting is highlighted white type on a blue background You can select either Dansk Deutsch English Español Français Italiano Nederlands Norsk Português Suomi Svenska Setup Menu 09 15 am 05 29 2015 QC Settings ID Setup Diagnostics Options Screen Screen 09 15 am 05 29 2015 Language Selection Result Confirmation Date Time Result Units Contrast Main Menu 09 15 am 05 29 2015 Control Test Review ...

Page 53: ...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 05 29 2015 Deutsch English Español Dansk Français Both Date and Time display formats are controlled by the Format options you s...

Page 54: ...eturns 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 Setup Menu 09 15 am 05 29 2015 QC Settings ID Setup Diagnostics Options Screen Screen 09 15 am 05 29 2015 Language Selection Result Confirmation Date Time Result Units Contrast Main Menu 09 15 am 05 29 2015 Contro...

Page 55: ...he 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 Setup Menu 09 15 am 05 29 2015 QC Settings ID Setup Diagnostics Options Scre...

Page 56: ... current settings are highlighted You can select one of the following display formats Date DD MM YYYY Day Month Year e g 29 05 2015 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 Setup Menu 09 15 am 05 29 2015 QC Settings ID Setup Diagnostics Options Screen Screen 09 15 am 05 29 2015 Language Selection Result Confirmation Date Time Resul...

Page 57: ...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 05 29 2015 Format Set Time Set Date Format 09 15 am 05 29 2015 Date DD MM YYYY MM DD YYYY YYYY MM DD Time 24H 12H ...

Page 58: ...by date and time or by per son based on the Patient ID 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 05 29 2015 Auto Off Connection Beeper Sort Parameter Selection Setup Menu 09 15 am 05 29 2015 QC Settings ID Setup Diagnostics Options Screen Main Menu 09 15 am 05 29 2015 Control Test Review Resul...

Page 59: ...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 139 Sort 09 15 am 05 29 2015 Date Time Patient ID Sort ...

Page 60: ...strip is complete and you need to apply a sample it detects a sample the test is completed and the results are displayed a long beep an error occurs three short beeps an external power adapter is connected when the meter is on the meter is docked 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 t...

Page 61: ...er 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 05 29 2015 Auto Off Connection Beeper Sort Parameter Selection Setup Menu 09 15 am 05 29 2015 QC Settings ID Setup Diagnostics Options Sc...

Page 62: ...e Setup Menu touch Options 3 From the Options menu touch Auto Off Options 09 15 am 05 29 2015 Auto Off Connection Beeper Sort Parameter Selection Setup Menu 09 15 am 05 29 2015 QC Settings ID Setup Diagnostics Options Screen Main Menu 09 15 am 05 29 2015 Control Test Review Results Setup Patient Test If the meter is connected to the power adapter or the Handheld Base Unit the Auto Off function has...

Page 63: ...change with external devices The meter can be con nected either to a computer DMS or a printer In addi tion to this direct data output test results may also be encoded as QR codes which can be scanned to be used with other applications 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 05 29 201...

Page 64: ...such as an electronic health record coagulation management software etc For this option further parameters URL encryption key must be set 6 Touch Plain Text Coded Data or URL Transmission depending on the intended use Your selection is now highlighted Ensure that your environment for reading QR codes QR code reader operating system text processing application is appropriate for your language Disre...

Page 65: ...ecialized service provider Use to switch to input of numbers Use to switch back to input of text Use to backspace and correct a mistake 9 Touch to save this setting or touch to exit this menu without saving any changes The display automatically returns to the previous screen QR Code 09 15 am 05 29 2015 Show QR code On Off Plain Text Coded Data URL Transmission URL Transmission 09 15 am 05 29 2015 ...

Page 66: ...want the meter to generate a new encryption key 11 Touch twice to return to the QR Code menu 12 Touch to save this setting or touch to exit this menu without saving any changes The display automatically returns to the previous screen This information needs to be exchanged once with your specialized service provider prior to using the URL transmission method Contact your specialized service provide...

Page 67: ... when activated can be used together with a DMS 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 13 Touch Compu...

Page 68: ...Options 09 15 am 05 29 2015 Auto Off Connection Beeper Sort Parameter Selection Setup Menu 09 15 am 05 29 2015 QC Settings ID Setup Diagnostics Options Screen Main Menu 09 15 am 05 29 2015 Control Test Review Results Setup Patient Test 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 th...

Page 69: ...ons 3 From the Options menu touch Parameter Selection 4 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 5 Touch to save this setting or touch to exit this menu without saving any changes Options 09 15 am 05 29 2015 Auto Off Connection Beeper Sort Parameter Selection Setup Menu 09...

Page 70: ...pending 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 enabling yo...

Page 71: ... 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 139 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 72: ...emory Wireless Setup If an Admin ID 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 ID this ID will have to be entered from this point forward before any of the set tings above can be changed The Admin ID must also be entered before you can delete or change the Admi...

Page 73: ...st entry 10 Touch to save this entry the Admin ID is now set or touch to exit this menu the Admin ID 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 72 Pay close attention to the buttons you press because the characters are n...

Page 74: ...in button is highlighted which means an Admin ID is active 4 Touch Admin 5 Using the keypad displayed on the screen enter and confirm the new Admin ID 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 05 29 2015 Patient Operator Admin Setup Menu 09 15 am 05 29 2015 QC Settings ID Setup Diagnostics Options Screen Main Menu 09 15 am 05 29 2015 Control...

Page 75: ...se the keypad on the screen without entering a password The Admin ID has been deleted and therefore deacti vated 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 05 29 2015 Patient Operator Admin Setup Menu 09 15 am 05 29 2015 QC Settings ID Setup Diagnostics Options Screen Main Menu 09 15 am 05 29 2015 Control Test ...

Page 76: ... 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 Data handling ...

Page 77: ...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 software a...

Page 78: ...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 Patient ID...

Page 79: ...t 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 Scan QC Material The barcode scanner of the CoaguChek Pro II meter can be used to scan barcodes from QC material vials This function c...

Page 80: ... selected and displayed No target value is dis played Custom Range The allowed percentage deviation from target value can now be customized Addi tionally you can choose between displaying the target value along with a control test result or not displaying the target value with the control test result 5 Touch the button with the setting of choice Your selection is now highlighted QC Settings 09 15 ...

Page 81: ...ange you can now select an allowed deviation from target value in the range of 0 to 22 5 in the illustration 11 5 Note For the test parameter PT the percentage deviation from the target value is always defined using INR values Even if you have activated Quick in the setup the meter always calculates the devia tion using INR values This range is then converted to Quick in a second step As there is ...

Page 82: ...lue if set to On appear in a line below the control test result in the QC test and QC memory screens In the left hand screen Display target value is set to Off the custom range only is displayed below the control test result In the right hand screen Display target value is set to On both the custom range and the target value are displayed The target value here 2 9 appears in front of the custom ra...

Page 83: ... QC Settings 3 From the QC Settings menu touch Lockouts 4 From the Lockouts menu touch QC Lockout 5 Select the triggers for a quality control test based on lot and or time or number of strips QC Lockout is disabled by default For routine confirma tion of system reliability it is recommended to enable this feature The lockout triggers are set once and are valid for all parameters The events time in...

Page 84: ...ith your chosen option when changing the test strip lot 7 Touch and to display the interval of choice on the screen The date based intervals Daily Weekly Monthly each start at 00 00 midnight on every day every Monday or every first day of the month QC Lockout 09 15 am 05 29 2015 New Code Yes No Daily Weekly Monthly No QC Lockout 09 15 am 05 29 2015 New Code Yes No Monthly No of Hours No of Strips ...

Page 85: ...his menu without saving any changes 12 For every option except for No you must now indicate the number of levels at which the quality control must be performed 13 Touch to save this setting or touch to exit this menu without saving any changes The display automatically returns to the previous screen QC Lockout 09 15 am 05 29 2015 New Code Yes No Monthly No of Hours No of Strips Weekly QC Lockout 0...

Page 86: ...his 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 05 29 2015 Lockouts Scan QC Material QC Range Setup Menu 09 15 am 05 29 2015 QC Settings ID Setup Diagnostics Options Screen Main Menu 09 15 am 05 29 2015 Control Test Review Results Setup Patient Test Lockouts 09 15 am 05 29 2015 Operator Lockout QC Lockout ST...

Page 87: ...hted 8 Touch to proceed or touch to exit this menu without saving any changes 9 For every option except for No you must now indicate the number of levels at which the quality control must be performed 10 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 05 29 2015 Weekly Monthly Every 3 Mont...

Page 88: ...wed has been reached additional tests cannot be performed until you have successfully completed a qual ity 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 the label STAT Test when they are displayed see page 115 The number of STAT tests performed is counted per test parameter used Once the maximum number of ST...

Page 89: ...ghted 6 If you have enabled the option touch and to set the number of additional tests 7 Touch to save this setting or touch to exit this menu without saving any changes QC Settings 09 15 am 05 29 2015 Lockouts Scan QC Material QC Range Setup Menu 09 15 am 05 29 2015 QC Settings ID Setup Diagnostics Options Screen Main Menu 09 15 am 05 29 2015 Control Test Review Results Setup Patient Test Lockout...

Page 90: ... allow manual selection of a QC lot number from a list or touch Scan Only to prohibit manual selection Your selection is now highlighted 5 Touch to save this setting or touch to exit this menu without saving any changes QC Settings 09 15 am 05 29 2015 Lockouts Scan QC Material QC Range Setup Menu 09 15 am 05 29 2015 QC Settings ID Setup Diagnostics Options Screen Main Menu 09 15 am 05 29 2015 Cont...

Page 91: ...shown on your meter may differ 1 From the Main Menu touch Setup to open the meter settings 2 From the Setup Menu touch Diagnostics 3 From the Diagnostics menu touch the button of the diagnostics screen you want to display Diagnostics 09 15 am 05 29 2015 Software Hardware Memory Usage General Wireless Setup Setup Menu 09 15 am 05 29 2015 QC Settings ID Setup Diagnostics Options Screen Main Menu 09 ...

Page 92: ... CoaguChek Pro II Home location Mannheim Last synchronization 05 28 2015 Non transmitted results 21 Next scheduled control test 05 30 2015 00 00 Hardware 09 15 am 05 29 2015 Serial no HBM HW MM HW U76001234 3 53a 03 Wireless Setup 09 15 am 05 29 2015 Wireless Setup Network Use DHCP Use DNS SSID MAC WLAN Enabled Disabled SSID123456 1A 3E B6 78 9C AF Wireless Setup 09 15 am 05 29 2015 Wireless Setup...

Page 93: ...llary Tubes Bulbs optional Cotton ball and alcohol wipe 4 1 Important notes Always close the strip container immediately after remov ing a test strip operate the meter at an ambient temperature between 12 C and 32 C 54 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 kee...

Page 94: ...eat 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 17 Dispose of all test strips used for patient testing in accordance with the disposal policy of your laboratory or practice see page 17 CAUT...

Page 95: ...echniques until the fingertip has increased color Immediately after lancing massage gently along the side of the finger to obtain a sufficiently large 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 Prepare the selected blood collecti...

Page 96: ...t 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 relating to bloo...

Page 97: ...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 a...

Page 98: ...ode 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 a corre sponding error message appears in the display refer to the Troubleshooting section of this manual ...

Page 99: ...ng The next steps depend on whether you work with the function Operator ID set to inactive or active see Data handling on page 139 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 05 29 2015 Control Test Review Results Setup Patient Test ...

Page 100: ...ce of approx 10 20 cm 4 8 inches according to the barcode size The meter beeps once the bar code 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 145 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 su...

Page 101: ...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 Scanned operator IDs must also be on the list Otherwise the login attempt will fail and an error mes sage will be displayed Note Extended data handling functionality and opera tor login options are dependent on the capabilities of the particular Data Management S...

Page 102: ...rmed for parameters that are still unlocked or as a STAT test if this function is enabled and if there are still STAT tests available In these cases a QC status screen will be displayed after touching Patient Test For more details on STAT test configuration see pages 88 and 115 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 ...

Page 103: ... 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 9 1 For configuring operator and patient IDs see page 145 Patient ID A B C D E F G H I J K L M N O P Q R...

Page 104: ...eypad Test 09 15 am 05 29 2015 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 Note Extended data handling functionality and patient ID entry options are dependent on the capabilities of the particular Data Management System DMS being used and may vary For more de...

Page 105: ...ox 10 20 cm 4 8 inches according to the barcode size The meter beeps once the barcode has been read suc cessfully The barcode information appears in the patient ID field The scanner turns off after 10 seconds if a bar code is not scanned 1 A list of supported barcode symbologies can be found in Appendix A 2 on page 166 a list of supported characters in Appendix A 3 on page 169 ...

Page 106: ...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 indicates that the meter has detected the test strip provided the beeper is enabled The testing procedure for both parameters is similar For illustration purposes testing with PT test strips is shown as an example Test 09 15 am 05 29 2015 aPTT PT Test 09 15 am 05 29 2015 P ID P...

Page 107: ...rovided 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 countdown begins You must apply the drop of blood to the test strip before the countdown ends Otherwise you will receive an error message When the test is running no operator action is required The display ...

Page 108: ...lood 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 CoaguChek Lancets professional use lanc...

Page 109: ...apply one drop of blood at least 8 μL but not more than 20 μL directly onto the target area of the test strip Ensure that no air bubbles are introduced into the sample If too much blood has been applied 20 μL the exterior of the meter and the test strip guide should be cleaned and disinfected For additional information on sample collection see page 96 ...

Page 110: ...ranges for CoaguChek PT test strips and for CoaguChek aPTT test strips refer to the package insert of the respective test strip Results that are above or below the measuring range are indicated by the symbols above or below Do not add more blood To avoid error messages do not touch the test strip until the result is displayed Test 09 15 am 05 29 2015 P ID PID01 Code 184 Smith Henry Op Operator 1 P...

Page 111: ... e g wet hands Repeat the test If using capillary blood make sure that the patient s hands are dry If 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 information screen Test 09 15 am 05 29 2015 P ID PID05 Code 208 1 6INR Müller David Op Schulz Par PT 05...

Page 112: ...ect the result this test result is no longer dis played However the test entry is stored Test 09 15 am 05 29 2015 P ID PID01 Code 184 2 5INR Smith Henry Op Operator 1 Par PT Measurement Result OK 21 Q 05 29 2015 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 05 29 2015 P ID PID01 Code 184 Smith Henry Op Operator 1 Par...

Page 113: ...ted the 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 ...

Page 114: ...8 Main tenance and Care The QR code icon only appears if the QR code dis play function is activated see page 64 and following Otherwise it is not displayed Test 09 15 am 05 29 2015 P ID PID01 Code 184 2 5INR Smith Henry Op Operator 1 Par PT Doctor Notified Sick NEW MEDICATION 21 Q 05 29 2015 11 31 am Test 09 15 am 05 29 2015 Remove 09 15 am 05 29 2015 Protection against infection When collecting s...

Page 115: ...m 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 Main Menu 09 15 am 05 29 2015 Control Test Review Results Setup Patient Test Logout QC Test 09 15 am 05 29 2015 PT QC status Locked a...

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Page 117: ... to assist you in meeting regulatory compliance require ments at your facility To perform an optional liquid quality control test using control solutions you need CoaguChek Pro II 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 PT Cont...

Page 118: ...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 dropper neck point i...

Page 119: ...lity 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...

Page 120: ...escribed on page 100 4 Check the battery level 5 Check that the date and time are correct Correct any wrong entries as described in Chapter 3 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 by pressing In both cases restore ...

Page 121: ... into the test strip guide in the direction indicated by the arrows Slide the test strip in as far as it will go A beep indicates that the meter has detected the test strip provided the beeper is enabled QC Test 09 15 am 05 29 2015 Proficiency Test Control Test Main Menu 09 15 am 05 29 2015 Control Test Review Results Setup Patient Test QC Test 09 15 am 05 29 2015 Op Schulz Par PT QC Test 09 15 am...

Page 122: ...e 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 it matches the code printed on the bottle of the control solution Alternatively the control solution code can also be entered using the built in barcode scanner Touch Scan and scan the barcode on the label from a distance of approx 10 cm 4 inches The meter...

Page 123: ... the test and is waiting for the sample to be applied At the same time a countdown begins You must apply the sample within the displayed time otherwise you will receive an error message If the code chips get mixed up check the letter on the code chips to tell them apart A capital S in front of the number indicates that this code chip is for test strips A capital C in front of the number indicates ...

Page 124: ...draw up the dissolved contents of the bottle 15 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 125: ...to the result refers to the INR result only Regardless of the Result Units settings chosen for PT aPTT is always displayed in seconds see page 50 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 05 29 ...

Page 126: ... the test strip from the meter 21 Power the meter off 22 Remove the quality control code chip from the meter and store it with the controls 23 Clean the meter if necessary see Chapter 8 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 05 29 2015 New Control Lot Cleaned Meter Doctor Notified Acceptable Cntrl Cust...

Page 127: ... test The samples 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 should be Some regulatory agencies require that these proficiency samples be tested as part of an institution s quality assurance program before an institution can be certified When using...

Page 128: ...nstead 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 of the test strips used The correct test strips must be available The proficiency sample must be available If you are using the test strip lot for the first time make sure that the code chip supplied ...

Page 129: ...as described on page 100 4 Check the battery level 5 Check that the date and time are correct Correct any wrong entries as described in Chapter 3 Meter Setup Setting the date If the battery icon turns red one bar remaining there may not be enough power available for another test If there are no bars remaining in the battery icon you cannot perform any more tests Power the meter off by pressing In ...

Page 130: ...t strip into the test strip guide in the direction indicated by the arrows Slide the test strip in as far as it will go A beep indicates that the meter has detected the test strip provided the beeper is enabled QC Test 09 15 am 05 29 2015 Proficiency Test Control Test Main Menu 09 15 am 05 29 2015 Control Test Review Results Setup Patient Test Proficiency 09 15 am 05 29 2015 Exposure to external i...

Page 131: ...sample 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 the displayed time or an error message will be displayed Proficiency 09 15 am 05 29 2015 QC 202 Code 101 Par aPTT Sample ID A 202 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 P...

Page 132: ...omatically added If you want to add further comments touch The test result is auto matically saved to memory After the test result is displayed touch You will be prompted to remove the strip 13 Remove the test strip from the meter 14 Power the meter off 15 Clean the meter if this becomes necessary see Chapter 8 Maintenance and Care Proficiency 09 15 am 05 29 2015 QC 202 Code 101 Par aPTT Proficien...

Page 133: ...ontrol solution code chips are stored If you are using operator and or patient lists a maximum of 5000 Operator and 4000 Patient IDs is allowed If the 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 arch...

Page 134: ... 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 3 Wait until the main menu is displayed Main Menu 09 15 am 05 29 2015 Control Test Review Results Setup Patient Test ...

Page 135: ...atient 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 Otherwise it is not displayed Main Menu 09 15 am 05 29 2015 Control Test Review Results Setup Patient Test Memory 09 15 am 05 29 2015 QC Result Patient Result Memory 09 15 am 05 29 2015 PT aPTT All r...

Page 136: ... am 05 29 2015 P ID PID01 Code 250 2 5INR Smith Henry Op Operator 1 Par PT Doctor Notified Sick New Strip Lot 21 Q 05 28 2015 11 31 am Memory 09 15 am 05 29 2015 P ID PID01 Smith Henry 05 28 2015 11 31 am 2 5 INR 21 Q 05 26 2015 10 15 am 3 0 INR 16 Q 05 25 2015 09 58 am 1 7 INR 38 Q Memory 09 15 am 05 29 2015 PID02 05 27 2015 10 10 am PID01 05 26 2015 10 15 am PID01 05 25 2015 09 58 am PID01 05 28...

Page 137: ... to the entry of choice on the screen 2 Touch the entry you want to open The entry is displayed Memory 09 15 am 05 29 2015 1 2 INR New Control Lot New Strip Lot 78 Q 05 28 2015 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 05 29 2015 05 27 2015 10 05 am QC 234 Pass 05 26 2015 10 07 am QC 623 Pass 05 25 2015 10 30 am QC 333 Pass 05 28 2015 11 31 am QC 99...

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Page 139: ...lists operator lists and settings from the DMS to the meter In this way the setup for daily work as well as general meter setup can be performed for one or more meters quickly and conveniently 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 yo...

Page 140: ... The different operator and patient lists that match a site or unit are then made available on their respective meters Other settings such as QC Lockout and Operator Lockout may easily be set once and distributed to all meters The option of setting up an Operator Lockout is availa ble only when operator lists are created on the DMS stored in the meter and Operator login is activated For more detai...

Page 141: ... 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 142: ...ell The Operator can only log in via a barcode scan as there is no onscreen keypad The use of the meter is not restricted to a predefined Operator group so Operator IDs are read from the barcode and stored with test results for informational purposes only Meters which are managed by a DMS may receive an Operator list Operator is activated a list is available and dis played on the login screen The ...

Page 143: ...e g name date of birth There are four possible configurations for a Patient ID input The Patient ID is set to Optional or Required and there is no list available A Patient ID can be entered manually via the onscreen keypad 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 whe...

Page 144: ...nt ID is on the list the test will proceed If the patient ID is not on the list you will get an error message Patient list validation Depending on DMS settings you have the following options for patient list validation when working with Patient lists A Patient ID does not have to be on the list to be used only valid for validation mode off The meter displays a warning if the Patient ID entered is ...

Page 145: ...lts and comments When performing a test the test result will be stored along with additional information including the Patient ID Operator ID the kind of test performed and optional Comments The meter comes with a default set of 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 ava...

Page 146: ...epeat 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 Handheld Base Unit ...

Page 147: ...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 10 ...

Page 148: ... 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 Observe the ...

Page 149: ... should be cleaned and disinfected before being used on another patient The exterior of the meter and the test strip guide should be cleaned and disinfected if too much blood 20 μL has been applied Maintenance cleaning The use of the disinfecting cloths may lead to a build up of residue on the test strip guide and battery compartment that needs to be removed Frequency whenever residue build up is ...

Page 150: ...isture Ensure that no liquid enters the meter If moisture enters the meter it may cause malfunction of the instrument Make sure the meter is turned off Do not spray anything onto the meter housing Do not spray into the test strip guide Do not immerse the meter in liquid Do not use cloths or swabs buds that are saturated Squeeze off excess solution or blot on a dry paper towel to remove any excess ...

Page 151: ...of 1 propanol 400mg g 2 propanol 200 mg g and glutaraldehyde 1 0 mg g 1 10 sodium hypochlorite solution 1 part bleach to 9 parts de ionized water made fresh every 24 hours Disposable wipes containing quaternary ammo nium compounds up to 0 5 single compound or mixture in isopropyl alcohol isopropanol up to 55 1 Sold in some countries under the name Bacillol Plus NOTICE Do not use any other disinfec...

Page 152: ...l moisture and fluids after cleaning the housing Visually verify that no solution is seen any where on the housing or touchscreen at the com pletion of cleaning and disinfecting 3 Allow wiped areas to dry for at least 10 minutes before performing the next patient test Ensure that the blue test strip guide cover remains tightly closed while cleaning the meter housing Do not let liquid accumulate ne...

Page 153: ...ide cover to clean it Use your thumbnail to open the cover of the test strip guide by pressing its front edge upward Move the cover safely away from the meter Then rinse the cover with warm water or wipe it clean using the solutions recommended above Let the test strip guide cover dry for at least 10 minutes before re attaching it 2 Hold the meter upright with the test strip guide facing down Clea...

Page 154: ...e assembling them 4 Re attach the test strip guide cover to the housing Make sure that the cover is properly closed You will hear it snap into place 8 6 Cleaning the scanner window The scanner window should be cleaned periodically Use a clean dry cloth to wipe the scanner window NOTICE Damage to the instrument Ensure that no liquid enters the meter when clean ing the test strip guide If moisture e...

Page 155: ...companied 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 Diagnostics see page 163 The two different message types are illustrated below Message Description I 001 Battery Low Status message Touch to proceed with the next step E...

Page 156: ...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 abnormal or unusually long clotting times may receive an E 406 message on the meter display If this error mes sage appears again when the test is repeated the result must be ...

Page 157: ... 38 Is the battery pack properly installed in the meter Does the meter power on when connecting the external power adapter Does the battery pack charge properly 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 th...

Page 158: ...Enter the date and time After you have entered the correct information confirm each screen with Unless all lockouts are disabled see chapter 3 5 the meter will now be in QC Lockout due to the manually entered date time 4 Synchronize the meter s date time with the date time of your facility via the Handheld Base Unit or if working wirelessly wait at least ten minutes for the next WLAN synchronizati...

Page 159: ...s with corresponding 2nd ID e g Operator Name Patient lists up to 4000 Patient IDs with corresponding 2nd and 3rd Patient IDs e g name date of birth Interface Touchscreen and barcode scanner Battery operation Universal Battery Pack for the CoaguChek Pro II meter Power connection Power supply adapter Input 100 240 V 50 60 Hz 350 150 mA Output 12 V DC 1 25 A Number of tests with a fully charged batt...

Page 160: ... and damage the meter At temperatures below 10 C 14 F the battery pack does not have enough power to keep the internal clock functioning Temperature range Meter without battery pack 25 C to 70 C 13 F to 158 F Temperature range Meter with battery pack 10 C to 35 C 14 F to 95 F Relative humidity 10 to 85 no condensation Temperature range Meter without battery pack 25 C to 70 C 13 F to 158 F Temperat...

Page 161: ... for detailed product data and limitations Item Description Remarks CoaguChek PT Test CoaguChek aPTT Test PT test strips for the CoaguChek Pro II meter aPTT test strips for the CoaguChek Pro II meter International edition not available in the US CoaguChek PT Controls CoaguChek aPTT Controls Optional liquid controls Level 1 Level 2 for the CoaguChek Pro II system CoaguChek Capillary Tubes Bulbs Cap...

Page 162: ...nsing conditions are available in English 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 Handheld Base Unit to a PC with the USB cable For detailed instructions on how to do this see the Operat...

Page 163: ...ntative If you do not already have contact details Visit our website at www roche com Select Roche in your country at the top of the page and then select your country to find the appropriate local office contact information or Visit our website at www coaguchek com Locate the CoaguChek Worldwide box on the page and select your country The CoaguChek Pro II system is manufactured for and distributed...

Page 164: ...164 11 Warranty The statutory guarantee provisions on rights in consumer goods sales in the country of purchase shall apply ...

Page 165: ...ber 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 denotes that the scan data character must be equal to t...

Page 166: ...patient misidentification and therefore to inappropriate therapy decisions When creating patient or operator barcodes always adhere to the applicable international IEC ISO standards for the respective barcode symbology In particular ensure that barcode size and print quality as defined in ISO IEC 15416 and 15415 are adequate Inadequate print size and or quality may lead to erroneous decoding In ad...

Page 167: ...orrectly this may lead to patient misidentification and therefore to inappropriate therapy decisions If used nonetheless make sure that the very highest quality standards of barcode creation and reproduction are applied for EAN13 do not use the start sequences 978 ISBN and 979 ISMN as they will be ignored as a part of any ID code Recommended Specification Remarks Print resolution 300 dpi preferred...

Page 168: ...168 Codabar Code 39 Code 93 Code 128 EAN 13 Interleaved 2 5 PDF417 QR Code DataMatrix ...

Page 169: ...ers 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 scanner does not support Asian characters ...

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Page 171: ...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 172: ... 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 05 29 2015 Ann Casey Alan Smithee Scan Pat Test OTS 09 15 am 05 29 2015 Observer Login P...

Page 173: ...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 05 29 2015 Observer Login Patient Test OTS enabled Remove 09 15 am 05 29 2015 Observer Login Observer ALAN SMITHEE please log in to proceed Otherwise the OTS test...

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Page 175: ...m on your wireless network Whether your meter has wireless capability or not depends on the system configuration that you purchased For information on WLAN registration see addendum WLAN registration information Addendum to the Operator s Manual for the CoaguChek Pro II meter at www coaguchek com 1 The CoaguChek Pro II system is certified by the Wi Fi Alliance Item Description REF Catalog Number C...

Page 176: ... of the Access Point the presence of electromagnetic disturbances and other potential inter fering factors e g concrete walls The CoaguChek Pro II meter uses a burst like communi cation protocol that will only consume bandwidth if there is actually data to be transferred Compared to other applications such as Voice over Internet Protocol VoIP or multi media applications the meter s bandwidth con s...

Page 177: ...signals and interferences building structure related and other wireless equipment devices As part of an RF implementation of the CoaguChek Pro II system it is recommended that at minimum one Hand held Base Unit be hard wired per floor A networked Handheld Base Unit provides redundancy if a wireless network malfunctions or loses service If the CoaguChek Pro II meter with RF is used in an area with ...

Page 178: ...nterprise and WPA2 Personal and Wired Equivalent Privacy WEP security mecha nisms with Temporal Key Integrity Protocol TKIP and Advanced Encryption Standard AES The CoaguChek Pro II meter interoperability Wi Fi certificate can be accessed at http certifications wi fi org search_products php Further information including a glossary of terms frequently asked questions and other topics related to Wi ...

Page 179: ...tes to informa tion in the DMS are sent immediately to all networked meters Meters with an integrated and activated wireless option use the Handheld Base Unit for recharging and or as a redundant communication option to exchange data with the DMS The meter also has to be docked if the hospital changes security protocols When this change occurs it may lock out all meters until docked and reconfigur...

Page 180: ...en the CoaguChek Pro II meter will attempt to connect to the DMS In line with the industry communication standard POCT1 A the DMS must acknowledge the meter s request for connection and actively query for the result Only upon receipt of this DMS query the meter will send the result Hence the effective time for transmitting results depends on infrastructure DMS workload etc Once the DMS sends a que...

Page 181: ...nication can be guaranteed The CoaguChek Pro II system is designed such that it coexists with other wirelessly communicating devices The CoaguChek Pro II system does NOT include any real time or even time critical wireless functionality It commu nicates exclusively single digital data fields It does NOT communicate continuous waveform data During the exchange of large data packages a short term de...

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Page 183: ...ng 113 Computer 67 Connection 63 68 Consumables 161 Contrast 49 Control solution Applying 124 Code chip 122 Preparing 118 Custom range 80 81 D Data transfer 139 141 Date 54 Disinfection 150 154 Display Format 56 Icons 30 31 Disposal 18 34 96 114 126 132 E Error messages 155 F Fingertip 108 H Handheld Base Unit 29 36 41 67 139 141 161 177 I Icons Drop 107 Dropper 123 131 Hourglass 107 123 131 Ident...

Page 184: ...iciency test Preparing 128 Putting the meter into operation 35 41 Q QC Range 80 QC Settings 79 85 QR code 64 66 Quality Control Lockout 83 102 Memory 137 Preparing 118 Result 125 132 R Relative humidity 27 159 Reset 158 Result confirmation 51 112 Review Results 133 146 Data transfer 139 141 RF radio frequency 23 177 S Safety Protection against infection 17 User qualification 17 Scan button 100 105...

Page 185: ...arget value 82 Temperature range 27 93 159 Test principle 13 Test result patient test 110 Test result quality control 125 132 Test strip Icon 106 121 130 Inserting 106 121 130 Test strip guide cover 153 Thromboplastin 13 Time 55 Troubleshooting 155 U Unit test result 110 Units of measure 50 V Voltage 27 W Warranty 164 Wi Fi 24 WLAN 175 181 ...

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Page 187: ......

Page 188: ... 7154879001 02 2015 11 EN 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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