Roche CoaguChek XS System Operator's Manual

CoaguChek XS Pro® POINT OF CARETESTINGOperator’s Manual

Introduction10If you need help Information about using the system, the screen menus, and performing a test can be found in this manual. When error mes

Testing a Blood Sample100STAT testsSTAT tests are a limited number of tests that can be performed in emergency situations, see page 76. If the meter i

Control Testing and Quality Control1016 Control Testing and Quality ControlThe CoaguChek XS Pro meter has a number of built-in quality control functio

Control Testing and Quality Control102Preparing to run a liquid quality control testPrepare for a liquid quality control test in the same way you woul

Control Testing and Quality Control1037 Apply gentle pressure to the reservoir to transfer the entire contents of the dropper to the bottle. Make sure

Control Testing and Quality Control104Performing a liquid quality control test1 Place the meter on a level, vibration-free surface or hold it in your

Control Testing and Quality Control1054 Check the battery level. If the battery icon turns red (one bar left), there may not be enough power left fo

Control Testing and Quality Control1067 The test strip icon prompts you to insert a test strip. Remove a test strip from its con-tainer and close the

Control Testing and Quality Control107If you are using a new test strip lot and have not inserted the test strip code chip yet, you must do so now. Ot

Control Testing and Quality Control10811 If performing more than one level, select the level for this measurement.The hourglass icon shows that the te

Control Testing and Quality Control10912 Using the dropper, draw up the dissolved contents of the bottle. 13 Apply a single drop of control solution d

Introduction11The meter guides you through the test, step by step, using icons and instructions on the display. Each box of test strips has its own co

Control Testing and Quality Control110You hear a beep when you have applied enough control solution (provided the beeper is enabled). The dropper icon

Control Testing and Quality Control11114 If you want to add a comment, touch . 15 Select the desired predefined comment(s) from the pick list (if con

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Review Results1137 Review ResultsThe CoaguChek XS Pro meter can save 2000 patient test results as well as 500 liquid quality control tests to memory,

Review Results114Viewing test results1 Place the meter on a level, vibration-free surface, or hold it in your hand so it is roughly horizontal. 2 Powe

Review Results1154 Touch Review Results. 5 Select the type of results you want to view. Display Patient Result memory Display QC Result memoryThe fo

Review Results116Display patient result memoryThis memory area contains all test results for your patients, sorted according to the setting you chose

Review Results117Display QC (quality control) result memoryThis memory area contains all liquid quality control tests that were run, sorted chronolog-

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Extended Functionalities1198 Extended FunctionalitiesData handlingWhen used in conjunction with the Handheld Base Unit from Roche (available separatel

Introduction12Important safety instructions and additional informationThis section explains how safety-related messages and information related to the

Extended Functionalities120Operator listsAfter powering the meter on, an Operator login may be configured. There are four possible con-figurations for

Extended Functionalities121Patient listsWhen starting a Patient Test, there will be the option of either selecting a Patient ID from a patient list, e

Extended Functionalities122Barcode scannerUsing a DMS, the barcode scanner may be configured to accept only selected barcode symbol-ogies (e.g., EAN-1

Cleaning and Disinfecting the Meter1239 Cleaning and Disinfecting the Meter Make sure the meter is powered off. Do not spray anything onto the mete

Cleaning and Disinfecting the Meter124Cleaning/disinfecting the exterior (meter housing)Use the solutions recommended on page 123 for cleaning/disinfe

Cleaning and Disinfecting the Meter125Cleaning/disinfecting the test strip guideUse the solutions recommended on page 123 for cleaning/disinfecting th

Cleaning and Disinfecting the Meter126On completion of cleaning:Cleaning the scanner windowThe scanner window should be cleaned periodically. Use a cl

Troubleshooting12710 TroubleshootingThe CoaguChek XS Pro meter continually checks its systems for unexpected and unwanted con-ditions. These may arise

Troubleshooting128Additional information on error E-406Power the meter off and remove the test strip. Repeat the measurement using a new test strip an

Troubleshooting129Errors and unusual behavior without error messagesSome conditions may arise that have no associated error or status message.Message

Introduction13Illustrations in this manual show two different kinds of hands: Hand without glove Hand with glove A dashed arrow between screen illust

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General Product Specifications13111 General Product SpecificationsTechnical dataSample materialTemperature range +15 °C to +32 °C (59 °F to 90 °F)Rel

General Product Specifications132Storage and transport conditions* At temperatures above +50 °C/122 °F the batteries could leak and damage the meter.

General Product Specifications133Information about software licenses This product incorporates software modules developed under open source licenses.

Warranty13412 WarrantyThe statutory guarantee provisions on rights in consumer goods sales in the country of purchase shall apply.

Appendix13513 AppendixContact Roche ArgentinaProductos Roche S.A.Q. e I.Rawson 3150B1610BAL Ricardo Rojas, TigreBuenos Aires - Argentina Tel.: +54 (1

Appendix136ChileProductos Roche Ltda.Avda. Quilín 3750Macul, SantiagoTel.: +56 (2) 4413200ChinaRoche Diagnostics (Shanghai) Ltd12/F, Huaihai Plaza, N

Appendix137EcuadorRoche Ecuador S.A.Av. 10 de Agosto N36-239 y Naciones UnidasQuitoTel.:+593 (2) 2434347FinlandRoche Diagnostics OyPL 16002180 ESPOOPu

Appendix138IndonesiaPT. Roche IndonesiaDiagnostics DivisionArtha Graha Building 21st floorSudirman Central Business District – Lot 25Jl. Jend. Sudirma

Appendix139NetherlandsRoche DiagnosticsNederland BVTransistorstraat 411322 CK AlmereTelefoon: 0800 - 2882882 (gratis)New ZealandRoche Diagnostics N.Z

Introduction14Safety InformationOperator qualification Only trained healthcare professionals may operate the CoaguChek XS Pro system. Operators must h

Appendix140PortugalRoche Sistemas de Diagnósticos, Lda.Estrada Nacional, 249-12720-413 AmadoraTelefone: +351 21 425 7000www.roche.ptRussia « 

Appendix141TaiwanRoche Diagnostics Ltd.11F, No. 35, Min Quan E. Road, Section 3Taipei 104, TaiwanTel: +886 0800 258 458ThailandRoche Diagnostics (Thai

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Supplement for Observed Test Sequence14314 Supplement for Observed Test SequenceObserved Test Sequence (OTS) The Observed Test Sequence (OTS) function

Supplement for Observed Test Sequence144Using the OTS functionA request for an Observed Test Sequence comes from the DMS. The presence of the icon o

Supplement for Observed Test Sequence145Operator:1 Touch Patient Test.Perform the patient test as usual. Once the test is completed, the observer has

Supplement for Observed Test Sequence146This page intentionally left blank.

Index147IndexAAdapter (power supply) ...

Index148DisplayIcons ...

Index149MemoryButton ...

Introduction15Disposal of the SystemWARNINGInfection by a potentially biohazardous instrumentThe CoaguChek XS Pro system or its components must be tre

Index150RRelative humidity ...

Index151SymbolsError messages ...

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Notes153Notes

Notes154Notes

0 5548829001 (03) 2012-04 ENACCU-CHEK, COAGUCHEK and SAFE-T-PRO are trademarks of Roche.Roche Diagnostics GmbHSandhofer Strasse 11668305 Mannheim, Ger

Introduction16General CareLaser ScannerThe built-in barcode scanner emits a laser beam when activated.The built-in barcode scanner is a Class 1 laser,

Introduction17Operating conditionsTo ensure that the meter functions properly, please observe the following guidelines: Only use the meter at a room

The CoaguChek XS Pro Meter182 The CoaguChek XS Pro Meter ABCDGI JFH K LE

The CoaguChek XS Pro Meter19Overview of the meter elementsA TouchscreenShows test results, information, icons, and results recalled from memory. To se

Revision History Manual version Revision date ChangesVersion 1.0 2009-09 New documentVersion 2.0 2010-04 Update cleaning/disinfection, minor revision

The CoaguChek XS Pro Meter20Buttons and icons overviewThe buttons and icons that appear during normal operation are shown here, along with their respe

The CoaguChek XS Pro Meter21Apply liquid control (QC) sample (the time left to apply sample is counted down in the display)Insert the test strip code

The CoaguChek XS Pro Meter22Power supplyThe CoaguChek XS Pro meter can be operated with either the power adapter provided, four standard type AA alkal

The CoaguChek XS Pro Meter23The meter retains results in memory even when no batteries are inserted. All settings other than date and time (deleted af

Putting the Meter into Operation243 Putting the Meter into OperationBefore using the meter for the first time, perform the following steps: 1 Insert b

Putting the Meter into Operation25Inserting the batteries1 With the meter powered off, press the battery compartment cover release tab and slide the c

Putting the Meter into Operation26Powering the meter on and off3 Slide the battery compartment back onto the meter and close it.The meter powers itsel

Putting the Meter into Operation27Checking the software versionAfter displaying the Roche logo, the meter briefly displays the Init (for “initializati

Putting the Meter into Operation28This page intentionally left blank.

Meter Setup294 Meter SetupNote on presentation of screen elements in this manualButtons are screen prompts that cause something to happen when touched

0 5548829001 (03) 2012-04 ENOperator’s ManualCoaguChek XS Pro®

Meter Setup30Settings summary The diagram below shows all of the setup areas that can be accessed on the meter.SetupScreenOptionsID SetupQC SettingsRe

Meter Setup31* Default settings are labeled with an asterisk (*).Group Subgroup Setting Values *ScreenContrast 0 – 10 (5 *)Result Units INR *INR/SECIN

Meter Setup32* Default settings are labeled with an asterisk (*).Group Subgroup Setting Values *OptionsSort Date/Time *Patient ID Patient NameBeeperBe

Meter Setup33* Default settings are labeled with an asterisk (*). Group Subgroup Setting Values *ID SetupAdmin. (Administrator) Blank (Off) *Operator

Meter Setup34Screen setupThe Screen setup area contains the options for changing the display. ContrastUse the Contrast menu to adjust the display to y

Meter Setup35Result UnitsUse this setting to select the unit(s) of measure to be displayed with the results.4 Touch or to change the contrast in a

Meter Setup36The current unit of measure setting is high-lighted (white type on a blue background). You can select either: INR INR and seconds INR

Meter Setup37Result ConfirmationIn some circumstances, it may be useful for operators to confirm the validity of their results. Use this setting to pr

Meter Setup38Language SelectionUse this setting to select the language for all displays (that contain text).1 From the Main Menu, touch Setup to open

Meter Setup39Setting the dateWhen you power on the meter for the first time (or after a long period without power), the input field for the date autom

4© 2012 Roche Diagnostics GmbH. All rights reservedThe contents of this document, including all graphics, are the property of Roche Diagnostics. Infor

Meter Setup404 From the Date/Time menu, touch Set Date.5 Touch and to set the year, then the month, then the day.6 Touch to save this setting, o

Meter Setup41Setting the timeWhen you power on the meter for the first time (or after a long period without power), this Setup menu appears automatica

Meter Setup424 From the Date/Time menu, touch Set Time.5 Touch and to set the hours, then the minutes.6 Touch to save this setting, or touch t

Meter Setup43Setting the display options for date and timeSelect your preferred format for the date and time display.1 From the Main Menu, touch Setup

Meter Setup444 From the Date/Time menu screen, touch Format.The current settings are highlighted. You can select one of the following display formats:

Meter Setup45Options setup SortSort refers to the order in which measured and stored results are displayed when you use the Review Results function of

Meter Setup46The current setting is highlighted. You may select from the following sort options: By Date/Time By Patient ID By Patient Name4 Touch

Meter Setup47BeeperThe CoaguChek XS Pro meter can display information visually and alert you to special circum-stances with a Beeper. When the Beeper

Meter Setup481 From the Main Menu, touch Setup to open the meter settings..2 From the Setup Menu, touch Options.3 From the Options menu, touch Beeper.

Meter Setup49The current setting is highlighted. You may select from the following options:For the Beeper Off Low Medium HighFor the Key Click On

51 Introduction 9Before you start...

Meter Setup50Auto OffYou can set up your CoaguChek XS Pro meter so that it powers itself off automatically if it has not been used (no buttons touched

Meter Setup51You may select from the following options: Off (meter never powers itself off) Time until meter powers itself off:1…10, 15, 20, 25, 30,

Meter Setup52ConnectionIn the Connection menu you can configure the data exchange with external devices. The meter can be connected either to a comput

Meter Setup53ComputerThe CoaguChek XS Pro meter can connect with a computer or host system running appropriate software (that is, a DMS must be instal

Meter Setup54PrinterThe CoaguChek XS Pro meter can also connect directly to a printer. To use the printing feature you need an optional infrared print

Meter Setup55 4 Touch Printer. Your selection is now highlighted.5 Touch to save this setting, or:Touch to exit this menu without saving any chang

Meter Setup56ID setupUse the ID Setup menu to enter settings for user management and patient management. These settings are optional and set to Off/In

Meter Setup57The 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

Meter Setup58System Administrator (Admin.)In the default setting, the meter is not protected with an Admin. password, and all setup options are access

Meter Setup59If an Admin. password has not been set up yet:1 From the Main Menu, touch Setup to open the meter settings.2 From the Setup Menu, touch I

6ID setup...

Meter Setup604 Using the keypad displayed on the screen, enter the Admin. password of choice. The password can consist of up to 20 characters. Pay clo

Meter Setup619 Enter the Admin. password again (the keypad is automatically displayed again on the screen) to confirm the first entry.10 Touch to sa

Meter Setup62Changing an existing Admin. password:1 From the Main Menu, touch Setup to open the meter settings.2 From the Setup Menu, touch ID Setup.3

Meter Setup63Deactivating an existing Admin. pass-word:1 From the Main Menu, touch Setup to open the meter settings.2 From the Setup Menu, touch ID Se

Meter Setup64Operator ID In the default setting, the Operator login is not activated. You can either activate or deactivate Operator login on the mete

Meter Setup65Patient ID In the default setting, input of Patient IDs is set to No. This means each test is simply assigned a consecutive number. Howev

Meter Setup66You may select from the following options: No (tests will be assigned numbers automatically) Optional (automatic numbering or list/scan

Meter Setup676 Select the form for input of the Patient ID.You may select from the following options: Alphanumeric Enter any combination of letters a

Meter Setup68QC Settings setupThe QC Settings menu contains options for enforcing the performance of liquid quality controls by the operator at speci

Meter Setup69QC Range Liquid Quality control ranges can be customized to comply with local guidelines. The QC Range function enables you to narrow th

710 Troubleshooting 127Additional information on error E-406... 128Er

Meter Setup70If you selected Custom Range, the QC Range screen opens and offers you the following options: Display target value (On/Off) Deviatio

Meter Setup716 Use the arrows to to set the allowed per-centage deviation from the target value.Use the arrows on the left to adjust the whole number

Meter Setup72QC (quality control) LockoutThe QC Lockout ensures that the optional quality control tests are run on a regular basis. This is independen

Meter Setup734 Select the triggers, based on lot and/or time, for requiring a quality control test.You may select from the following options: New Cod

Meter Setup74Operator LockoutOptional liquid quality controls can be used to ensure that an operator is performing tests prop-erly on the CoaguChek XS

Meter Setup754 Select the interval of choice in which the mandatory quality control tests must be performed.You may select from the following options:

Meter Setup76STAT Test ConfigurationQuality control tests ensure consistent quality and accurate measurements. In emergency situa-tions, however, it m

Meter Setup771 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

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Testing a Blood Sample795 Testing a Blood SampleWhat you need: CoaguChek XS Pro meter CoaguChek XS PT Test Strips and matching code chip When test

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Testing a Blood Sample80Never … … store the meter at extreme temperatures (above 40 °C or 104 °F) while it is in regular use. … store the meter in d

Testing a Blood Sample81Getting a good capillary blood sampleTo get a suitable drop of blood: Warm the hand. Have the patient hold it under his or h

Testing a Blood Sample82Preparing to test1 Have the test strip container at hand.2 Make sure that the code chip supplied with these test strips is at

Testing a Blood Sample83Test strip code chipThe code chip provides the meter with important information that it needs to perform the coagu-lation test

Testing a Blood Sample84If the code chip is missing or incorrectly inserted, error messages appear in the display (refer to the Troubleshooting sectio

Testing a Blood Sample85Powering on the meterIf the function Operator ID is inactive:1 Place the meter on a level, vibration-free surface, or hold it

Testing a Blood Sample86If the function Operator ID is active: Without operator list:3 You are now prompted to enter an Operator ID. Enter the Opera

Testing a Blood Sample87With operator list:3 Wait until the operator list is displayed. 4 Select the operator of choice by touching the corresponding

Testing a Blood Sample88Performing a test1 Check the battery level. If the battery icon turns red (one bar left), there may not be enough power left

Testing a Blood Sample89Without patient list3 Touch Patient Test.4 If the Patient ID option was chosen as either Optional or Required when the meter w

Introduction91 IntroductionBefore you startIntended use The CoaguChek® XS Pro system (CoaguChek XS Pro meter and CoaguChek XS PT Test strips) quantita

Testing a Blood Sample90With patient list5 Touch Patient Test. 6 Touch and to display the entry of choice. Select the patient to be tested from th

Testing a Blood Sample91Alternatively, the Patient ID can also be entered via the built-in barcode scanner. Touch Scan and scan the patient barcode fr

Testing a Blood Sample928 The test strip icon prompts you to insert a test strip. Remove a test strip from its con-tainer and close the container agai

Testing a Blood Sample93The hourglass icon shows that the test strip is warming up. When the warming-up process is complete, a further beep (provided

Testing a Blood Sample94WARNINGUse only a lancing device that is approved for use by healthcare profes-sionals, such as the Accu-Chek Safe-T-Pro or Sa

Testing a Blood Sample95When applied from above, the blood must cover the entire sample application area.You hear a beep tone when you have applied en

Testing a Blood Sample96The meter performs an automatic quality con-trol test on the test strip before it displays the test result. “QC” appears in th

Testing a Blood Sample97Accepting or rejecting a test resultIf this function is enabled, you may choose to accept or reject a test result. When the re

Testing a Blood Sample98Adding commentsYou can add up to three comments to a test result. Comments can provide, for example, addi-tional information a

Testing a Blood Sample99After the test result is displayed, touch . You will be prompted to remove the strip.5 Remove the test strip from the meter.6