Roche ACCU-CHEK Inform II Betreibershandbuch

Inform IIACCU-CHEK ®BLOOD GLUCOSE MONITORING SYSTEMOperator’s Manual

Introduction10If you need help Information about using the system, the screen menus and performing a test can be found in this operator's manual.

Initial Startup100This display is visible when no communication takes place. This display is visible when software updates are trans-ferred to the met

Initial Startup101Initial setup on the meterThere are two ways to customize the setup of the meter: directly on the meter (see the following menu over

Initial Startup102Menu overview The following tables contain a brief overview of the menu structure. The menus can be used to operate the meter fully

Initial Startup103Main Menu 2Maintenance – Add Comment– Maintenance ResultProficiency – Enter Sample ID– Verify Strip Lot– Insert Test Strip– Apply Sa

Initial Startup104Admin MenuAdmin – Language– Date/Time– SetupLanguage – German– French– Spanish– Italian– Dutch– Swedish– English – Danish– Portugues

Initial Startup105Opening the Setup MenuAll settings described here are configured via the Setup Menu. To open the Setup Menu, proceed as follows:1 To

Initial Startup106Date and time formatUse this menu to select the date and time format for the display. You can also choose whether the operator is al

Initial Startup107Display options and optional testsUse this menu to select the unit of measure for test results and enable or disable optional tests.

Initial Startup108Options for test stripsThis menu allows you to select options for handling lot numbers and specify whether the operator is allowed t

Initial Startup109On the second settings screen, you can select options for handling lot numbers with glucose control and linearity tests. 1 Touch the

Introduction11What can the system do for you? The Accu-Chek Inform II system has the following fea-tures and properties: Perform patient blood glucos

Initial Startup110Options for glucose control testsThis menu contains options that allow you to specify whether and at what intervals glucose control

Initial Startup111Value ranges (normal, critical, reportable)This menu allows you to set limit values for results as Normal, Critical, or Reportable.

Initial Startup112Options for Operator ID EntryThis menu allows you to specify if and how operator login is performed. 1 Touch the desired option to e

Initial Startup113Patient ID optionsThis menu allows you to specify the criteria for entering a patient ID. 1 Touch the desired option to enable it:

Initial Startup114Creating a setup passwordThis screen allows you to create a password for all the settings described in this chapter. The password en

Initial Startup115Setting the date and timeThis setting can be hidden or require entry of a password, based on configuration.1 Touch in the Main Men

Initial Startup116Beeper optionsThis setting can be used to set the volume of the beeper.1 Touch in the Main Menu to open the Main Menu 2 screen. 2

Initial Startup117Diagnostics viewUnder Diagnostics you can find information about the system, such as software version, number of data records stored

Initial Startup118Unlocking a Download LockoutWhen using a data management system for configura-tion, a Download Lockout can be configured. This locko

Maintenance and Care11910 Maintenance and CareConditions for storage and shippingGeneral operating conditions Please observe the following points to e

Introduction12Safety information and additional informationThis section explains how safety-related messages and information related to the proper han

Maintenance and Care120Storage Store the system and test strips in the same environment in which they are used. Do not store the meter in direct su

Maintenance and Care121Cleaning the meter Wipe the surfaces with a soft cloth slightly dampened (not wet) or you may spray the meter per the directio

Maintenance and Care122Cleaning the base unit Unplug the base unit before cleaning. Wipe the surfaces with a soft cloth slightly dampened (not wet)

Maintenance and Care123Cleaning the accessory box Wipe the surface with a soft cloth slightly dampened (not wet). If spraying the accessory box, pla

Maintenance and Care124DisinfectingHealthcare professionals must wear gloves and follow their institution’s infection control procedures when han-dlin

Maintenance and Care125Disinfecting the meter Remove the meter from the base unit prior to disinfecting. Lay the meter on a flat surface while wipi

Maintenance and Care126WARNINGDo not spray directly into the strip port! Moisture in the strip port may lead to incorrect blood glucose results. If yo

Maintenance and Care127Disinfecting the base unit Remove the meter from the base unit prior to disinfecting. Unplug the base unit before disinfecti

Maintenance and Care128Disinfecting the accessory box Be certain that solutions contain acceptable active ingredients for disinfecting the system. If

Maintenance and Care129Logging maintenance activitiesCleaning and other maintenance activities can be logged in the meter. Make sure that all cleaning

Introduction13Important information regarding safetyDisposal of the systemOperator qualification Only trained healthcare professionals may operate the

Maintenance and Care130

Troubleshooting13111 TroubleshootingThe Accu-Chek Inform II meter continually checks its sys-tems for unexpected and unwanted conditions. A troublesho

Troubleshooting132Test result LO/HI The glucose result may be below (LO) or above (HI) the measurement range of the system.– Refer to the package inse

Troubleshooting133Base unitLED is not illuminated Not connected to power supply unit or power supply unit is defective, base unit is defective, or pow

Troubleshooting134Error messages All error messages displayed by the system are accompa-nied by a description of the error and a possible solution. Ta

Troubleshooting135– E: Error; touch to confirm. To resolve the problem, take the actions suggested.– W: Warning; touch to confirm.Sample message t

Troubleshooting136Meter reset A meter reset can be performed to correct a number of unspecified errors (e.g., “frozen” screen, etc.). Use the fol-lowi

General Product Information13712 General Product Information Technical data * Accu-Chek Inform II Base Unit Light: only red, green.Specification Meter

General Product Information138* Not applicable to Accu-Chek Inform II Base Unit Light Specification Meter Base unit Power supply unitBattery voltage/t

General Product Information139Further InformationOrdering Accu-Chek Inform II Operator’s Manual and Quick Reference GuideFor additional copies of the

Introduction14Product safety Observe the following information to ensure product safety: The system is suitable for continuous operation.General car

General Product Information140Information about software licensesThis product incorporates software modules developed under open source licenses. The

Appendix141A AppendixTable of configuration optionsThis section provides an overview of all the settings avail-able. The two rightmost columns describ

Appendix142Critical range HI limit 10 – 600 mg/dL0.6 – 33.3 mmol/L600 mg/dL33.3 mmol/LYYCritical range LO limit 10 – 600 mg/dL0.6 – 33.3 mmol/L10mg/dL

Appendix143Formats and LanguageDate format 1: MM/DD/YY2: DD.MM.YY1YYTime format 1: 24 hours 2: 12 hours2YYLanguage setting * 1: German3: French4: Span

Appendix144Operator IDOperator ID entry control 0: None1: Prompt2: Scan only3: Prompt (numeric only)1YYOperator ID entry control on Glucose control on

Appendix145Patient ID validation mode 0: none1: length2: list3: list allowing entry if not on list4: length if numeric0YYPatient ID length(Allowed cha

Appendix146Result deletionResult deletion algorithm 0: automatic1: FIFO1NYResult retention time (number of days since a result was measured before it

Appendix147WLAN settings (security)Cipher Type (encyrption method) 0: None (no cipher type)1: AES (symmetric key cryptography)2: TKIP (using dynamic k

Appendix148Subject/Attribute Range Default Device DMSObserved Test Sequence (OTS)OTS functionality * 0: disabled1: enabled0NY* Depends on available DM

Appendix149Allowed combinations of cipher and security typeOperator and patient ID barcode maskssecurity_type cipher_typewep_auth_typewep_keywpa_key_t

Introduction15Battery Pack The meter contains a rechargeable battery pack that begins charging as soon as it is placed in an active base unit (i.e., o

Appendix150Example of barcode symbologies– Codabar – Code 39– Code 93– Code 128– EAN 13– Interleaved 2 of 5

Appendix151B AppendixOption: Wireless network (WLAN)Application area The optionally available module for wireless network con-nectivity (RF card) allo

Appendix152

Index153IndexAAccessory boxCleaning ... 123Disinfecting ...

Index154IIconsIdentification plate ...4Packaging ...

Index155SSafetyProtection against infection ...13User qualification ...13Safety informa

Index156

Notes157Notes

Notes158Notes

159

Introduction16TouchscreenLaser scanner The built-in barcode scanner emits a laser beam when activated.The built-in barcode scanner is a Class 1 laser,

ACCU-CHEK, ACCU-CHEK INFORM, ACCU-CHEK PERFORMA and COBAS are trademarks of Roche. Roche Diagnostics GmbHSandhofer Strasse 11668305 MannheimGermany

Introduction17Radiofrequency radiation exposure informationNo operating limitations apply to meters without an RF card or to meters with an RF card th

Introduction18This device complies with Part 15 of the FCC Rules and with RSS-210 of Industry Canada. Operation is subject to the following two condit

Introduction19Note on systems with older hardwareThe Accu-Chek Inform II system complies with the emis-sion and immunity requirements described in IEC

2Manual version Revision date ChangesVersion 1.0 2008-01 New documentVersion 2.0 2009-08 Update, new SW version 02.00Version 3.0 2010-09 Update, new S

Introduction20This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to Part 15 of the FCC Rules. T

Introduction21System componentsThe Accu-Chek Inform II system includes the following components and accessories: A MeterB Code key readerC Base unit w

Introduction22Overview of the meterThe meter has the following elements: 1 Test strip portInsert the test strip here.2 Touchscreen(touch-sensitive dis

Introduction23Overview of the code key readerTest strip vials include a code key.1 This code key is read by the code key reader and the data is sent t

Introduction24Overview of the base unitTo provide flexibility in line with customer requirements, two versions of the base unit are available. The A

Introduction25Electrical connections are located on the back of the base unit (for a better view the removable wall mount is shown as transparent). Fo

Introduction26Instructions for initial setupThe meter must be configured prior to initial use. During this setup, the following parameters are configu

Powering Up and Entering an Operator ID272 Powering Up and Entering an Operator IDPowering up the meter1 Press and release the On/Off button . The met

Powering Up and Entering an Operator ID28Adjusting the display Using the Display options, you can adjust display param-eters to your needs: Adjust th

Powering Up and Entering an Operator ID29Enabling/disabling the RF card If the unit is equipped with an RF card, you can temporar-ily enable or disabl

©2010 Roche Diagnostics. All rights reserved. 0 4807839001 (03) 2010-09 ENOperator’s ManualAACCU-CCU-CHEKHEK ® Inform II System

Powering Up and Entering an Operator ID30Closing startup Once you have completed all the necessary changes, touch to proceed to the screen used to

Powering Up and Entering an Operator ID31Entering an operator ID with barcode scannerWhen the screen for entering the operator ID is displayed:1 Press

Powering Up and Entering an Operator ID32Entering the operator ID manuallyWhen the screen for entering the operator ID is displayed:1 Touch the letter

Patient Glucose Testing333 Patient Glucose Testing Information regarding blood glucose testingPreparing to test The following requirements must be met

Patient Glucose Testing34Performing a patient glucose testOverview of test procedure A patient glucose test comprises the following steps: Enter the

Patient Glucose Testing35You now have three different options, depending on setup, for assigning the subsequent test to a patient.* Depending on the D

Patient Glucose Testing36Entering the patient ID manually Use the displayed keypad to enter the patient ID. You can select characters in the same mann

Patient Glucose Testing37Selecting the patient ID from a listChoose the patient ID from a list*, if a list has been down-loaded to the meter (from the

Patient Glucose Testing38Entering a patient ID with barcode scannerWhen the screen for entering the patient ID is displayed:1 Press and release . The

Patient Glucose Testing39Confirming or selecting the test strip lotOnce you have entered and confirmed the patient ID, you are asked to choose the lot

4©2010, Roche Diagnostics. All rights reserved.The contents of this document, including all graphics, are the property of Roche Diagnostics. Informati

Patient Glucose Testing40Inserting test strips After confirming the test strip lot, you are prompted to insert the test strip.1 Remove the test strip

Patient Glucose Testing41Applying a blood sample Once the meter has detected the test strip, you are prompted to apply a blood sample. 1 Wait until th

Patient Glucose Testing42Results screen The hourglass icon indicates the test is running. When the test is completed and the result is ready, the mete

Patient Glucose Testing43 The System Measurement Range refers to the measurement range of the system itself (strips and meter) and is the only range

Patient Glucose Testing44The following messages may appear in addition to the standard test result: CR LO (below the Critical Range threshold, but wi

Patient Glucose Testing45Adding comments You can add up to three comments to a test result. Com-ments can provide, for example, additional information

Patient Glucose Testing46

Glucose Control Testing474 Glucose Control TestingInformation regarding glucose control testsObserve the applicable regulations and directives of the

Glucose Control Testing48Glucose control testing intervals Intervals between running glucose control tests are determined by your facility. These inte

Glucose Control Testing49Information stored during glucose control testingThe following information is stored for every glucose con-trol test using co

51 Introduction 9Before you start...

Glucose Control Testing50Performing glucose control testsOverview of test procedure A glucose control test using control solution comprises the follow

Glucose Control Testing51Starting a glucose control test After preparing the meter as described, you can proceed to the steps directly related to cont

Glucose Control Testing52Confirming or selecting the lot number for control solutionsOnce you have selected the level, you are asked to con-firm or en

Glucose Control Testing53Confirming or selecting the test strip lotOnce you have entered and confirmed the lot number of the control solution, you are

Glucose Control Testing54Inserting test strips After confirming the test strip lot, you are prompted to insert the test strip.1 Remove the test strip

Glucose Control Testing55Applying the control solution Once the meter has detected the test strip, you are prompted to apply the control solution. 1 W

Glucose Control Testing56Results screen The hourglass icon indicates the test is running. When the test is completed and the result is ready, the mete

Glucose Control Testing57Performing a STAT test The meter can be configured to allow a STAT patient glu-cose test to be run even if the meter is in QC

Glucose Control Testing58

Review Results595 Review ResultsDisplaying test results from the memoryInformation stored in data records for test resultsWhen you retrieve the data r

63 Patient Glucose Testing 33Information regarding blood glucose testing ...

Review Results603 Touch an entry in the list to display the related details.4 Touch Patient, if you wish to display results for a specific patient onl

Storing Test Strip, Control Solution, and Linearity Solution Information in the Meter616 Storing Test Strip, Control Solution, and Linearity Solution

Storing Test Strip, Control Solution, and Linearity Solution Information in the Meter62Transferring code key information to the meterThe following des

Storing Test Strip, Control Solution, and Linearity Solution Information in the Meter635 Place the code key reader on a level surface such as a bench.

Storing Test Strip, Control Solution, and Linearity Solution Information in the Meter64Information about the expiration date and parameters for contro

Storing Test Strip, Control Solution, and Linearity Solution Information in the Meter65The parameters for control solutions consist of four sepa-rate

Storing Test Strip, Control Solution, and Linearity Solution Information in the Meter66Once you have finished updating the test strip informa-tion, yo

Storing Test Strip, Control Solution, and Linearity Solution Information in the Meter67Storing control solution informationGlucose control solution lo

Storing Test Strip, Control Solution, and Linearity Solution Information in the Meter684 Select the level (L1/Lo or L2/Hi).5 Use the keypad to enter t

Storing Test Strip, Control Solution, and Linearity Solution Information in the Meter69Once you have finished updating the control solution informatio

77 Linearity Testing 77Information regarding linearity tests...

Storing Test Strip, Control Solution, and Linearity Solution Information in the Meter70Selecting a stored lot number as the current lot numberYou can

Storing Test Strip, Control Solution, and Linearity Solution Information in the Meter713 Touch the lot number you wish to select as the current lot nu

Storing Test Strip, Control Solution, and Linearity Solution Information in the Meter72Storing linearity test informationObserve the applicable regula

Storing Test Strip, Control Solution, and Linearity Solution Information in the Meter734 Use the keypad to enter the lot number.5 Touch to confirm t

Storing Test Strip, Control Solution, and Linearity Solution Information in the Meter74Selecting a stored lot number as the current lot numberYou can

Storing Test Strip, Control Solution, and Linearity Solution Information in the Meter753 Touch the lot number you wish to select as the current lot nu

Storing Test Strip, Control Solution, and Linearity Solution Information in the Meter76

Linearity Testing777 Linearity TestingInformation regarding linearity testsObserve the applicable regulations and directives of the responsible regula

Linearity Testing78Information stored during linearity testingThe following information is stored for every linearity test: Test result Lot number o

Linearity Testing79Performing a linearity testOverview of test procedure A linearity test comprises the following steps: Check the lot number of the

810 Maintenance and Care 119Conditions for storage and shipping ...

Linearity Testing80Confirming or selecting the lot number for linearity test kitsYou are now prompted to confirm or enter the lot number of the linear

Linearity Testing81In the Linearity Test menu, the levels available for the lin-earity test are displayed. 5 Touch L1 to start the subsequent test wit

Linearity Testing82Applying a linearity test sample Once the meter has detected the test strip, you will be prompted to apply the linearity solution.

Linearity Testing83Results screen The hourglass icon indicates the test is running. When the test is completed and the result is ready, the meter beep

Linearity Testing84

Proficiency Testing858 Proficiency TestingInformation regarding proficiency testsObserve the applicable regulations and directives of the responsible

Proficiency Testing86Information stored during proficiency testingThe following information is stored for every proficiency test: Test result Sample

Proficiency Testing87Performing a proficiency testOverview of test procedure A proficiency test comprises the following steps: Enter a sample ID for

Proficiency Testing88Entering the proficiency sample IDYou will now be asked to enter the sample ID. 1 Use the keypad to enter the sample ID, or2 Touc

Proficiency Testing89Inserting test strips After confirming the test strip lot, you will be prompted to insert the test strip.1 Remove the test strip

Introduction91 IntroductionBefore you startIntended use The Accu-Chek® Inform II system is intended for in vitro diagnostic use in the quantitative de

Proficiency Testing90Applying a proficiency sample Once the meter has detected the test strip, you are prompted to apply the proficiency sample. 1 Wai

Proficiency Testing91Results screen The hourglass icon indicates the test is running. When the test is completed and the result is ready, the meter be

Proficiency Testing92

Initial Startup939 Initial StartupConnecting the base unit1 Slide the base unit upward and remove it from the wall mount (if in use). 2 Connect the po

Initial Startup94Installing or replacing the battery packWhen shipped, the battery pack is not installed in the Accu-Chek Inform II meter. After insta

Initial Startup95Removing the battery pack 1 If a battery pack is already installed, make sure that the meter is switched off.2 Place the meter face d

Initial Startup96Installing the battery pack 1 Loosen the screws on the battery pack until they are protruding about 4-5 mm (2/10 in).2 Position the b

Initial Startup975 Place the tapering end of the battery pack on the small ledge of the opening and push down like a lid to close (as shown in the ill

Initial Startup988 Place a ruler across the back of the meter to check that the battery pack is properly positioned. The ruler should lie completely f

Initial Startup99Docking the meterDocking the meter in the base unit allows you to charge the battery. When docked, the meter shows different messages