Roche ACCU-CHEK Inform II Manual do Operador

ACCU-CHEK® Inform IIBLOOD GLUCOSE MONITORING SYSTEMOperator’s Manual

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Initial Startup100Installing the battery pack1 Loosen the screws on the battery pack until they are protruding about 2/10 inch.2 Position the batter

Initial Startup 1015 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

Initial Startup1028 Place a ruler across the back of the meter to check that the battery pack is properly positioned. The ruler should lie completely

Initial Startup 103Docking the meterDocking the meter in the base unit allows you to charge the battery. When docked, the meter shows different me

Initial Startup104This display is visible when communication is still active but the meter is busy processing the data received or waiting for the nex

Initial Startup 105Initial setup on the meterThere are two ways to customize the setup of the meter: directly on the meter (see the following menu

Initial Startup106Menu overviewThe following tables contain a brief overview of the menu structure. The menus can be used to operate the meter fully a

Initial Startup 107Main Menu 2Maintenance – Add Comment– Maintenance ResultProciency – Enter Sample ID– Verify Test Strip Lot– Insert Test S

Initial Startup108Admin MenuAdmin – Language– Date/Time– SetupLanguage – German– French– Spanish– Italian– Dutch– Swedish– English – Danish

Initial Startup 109Opening the Setup MenuThe following description assumes that the meter is powered on and the main menu is displayed. All settin

Introduction 111 IntroductionBefore you startIntended useThe ACCU-CHEK® Inform II test strips are for use with the ACCU-CHEK Inform II meter to qu

Initial Startup110Date 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 Startup 111Display options and optional testsUse this menu to select the unit of measure for test results and enable or disable optional t

Initial Startup112Options for test stripsThis menu allows you to select options for handling lot numbers and specify whether the operator is allowed t

Initial Startup 113On the second settings screen, you can select options for handling lot numbers with glucose control and linearity tests. 1 Tou

Initial Startup114Options for glucose control testsThis menu contains options that allow you to specify whether and at what intervals glucose control

Initial Startup 115Value ranges (normal, critical, reportable)This menu allows you to set limit values for results as Normal, Critical, or Reporta

Initial Startup116Options for Operator ID EntryThis menu allows you to specify if and how operator login is performed. 1 Touch the desired option to

Initial Startup 117Patient ID optionsThis menu allows you to specify the criteria for entering a patient ID. 1 Touch the desired option to enable

Initial Startup118Creating a setup passwordThis screen allows you to create a password for all the settings described in this chapter. The password en

Initial Startup 119Setting the date and timeThis setting can be hidden or require entry of a password, based on conguration. 1 Touch in the Ma

Introduction12Important information regardinguseRead this operator’s manual, as well as the package inserts for all relevant consumables, before usin

Initial Startup120Beeper 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 Startup 121Diagnostics viewUnder Diagnostics you can nd information about the system, such as software version, number of data records st

Initial Startup122Unlocking a Download LockoutWhen using a data management system for congura tion, a Download Lockout can be congured. This lockout

Maintenance and Care 12310 Maintenance and CareConditions for storage and shippingAll information given on maintenance and care of the “base unit

Maintenance and Care124Storagen Store the system and test strips in the same environment in which they are used. n Do not store the meter in direct

Maintenance and Care 125Guide to cleaning and disinfecting the ACCU-CHEK Inform II systemPrior to cleaning and disinfecting a blood glucose testin

Maintenance and Care126Acceptable Cleaning / Disinfecting AgentsTo purchase approved disinfecting products, please refer to your facility’s guidelines

Maintenance and Care 127What to Clean/DisinfectThe following parts of the meter and system components may be cleaned and disinfected: – The area a

Maintenance and Care128How to clean and disinfect the ACCU-CHEK Inform II systemWARNINGAvoid getting liquid into the test strip port! Failure to fol

Maintenance and Care 129Cleaning the meter1 Place the meter on a level surface prior to cleaning. 2 Power off the meter. Be certain that soluti

Introduction 13If you need helpInformation about using the system, the screen menus and performing a test can be found in this operator’s manual.Er

Maintenance and Care130Disinfecting the meter NOTE: The meter should be cleaned prior to each disinfection step. Remember to keep the meter on a level

Maintenance and Care 131 Logging maintenance activitiesCleaning, disinfecting, and other maintenance activities can be logged in the meter. Make s

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Troubleshooting 13311 TroubleshootingThe ACCU-CHEK Inform II meter continually checks its sys tems for unexpected and unwanted conditions. A troub

Troubleshooting134Display/symptom Possible solutionTest result LO/HI The glucose result may be below (LO) or above (HI) the measurement range of the s

Troubleshooting 135Display/symptom Possible solutionMeter displays Glucose Error Detection of an unexpected hardware error– Repeat the test or pro

Troubleshooting136Display/symptom Possible solutionPower off after time specied by system administrator (default is 5minutes, congurable by system

Troubleshooting 137Error messagesAll error messages displayed by the system are accompanied by a description of the error and a possible solution.

Troubleshooting138Sample message type Description– E: Error; touch to conrm. To resolve the problem, take the actions suggested.– W: Warning; tou

Troubleshooting 139Meter resetA meter reset can be performed to correct a number of unspecied errors (e.g., “frozen” screen, etc.). Use the fol lo

Introduction14What can the system do for you?The ACCU-CHEK Inform II system has the following fea tures and properties:n Perform patient blood glucos

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General Product Information 14112 General Product InformationTechnical dataSpecication Meter Base unit Power supply unitHeight 1.73 in / 44 mm

General Product Information142Specication Meter Base unit Power supply unitBattery voltage/type 3.7 volt rechargeable (lithium technology)N/A N/AInpu

General Product Information 143Specication ACCU-CHEK Inform II Test StripSystem measurement range: 10-600 mg/dLHematocrit 10-65 %Altitude up to 1

General Product Information144Reagents and SolutionsSupplies are available through Roche Diagnostics. Contact your local Roche representative. Inform

General Product Information 145A AppendixTable of conguration optionsThis section provides an overview of all the settings avail able. The two r

General Product Information146Subject/Attribute Range Default Device DMSComments requirement level: if out of ... (only valid if Comments required = 1

General Product Information 147Subject/Attribute Range Default Device DMSStrip lot verication 0: display only 1: yes/no conrmation 2: list selec

General Product Information148Subject/Attribute Range Default Device DMSMain menu 2 “Prociency” allowed (if enabled, prociency tests are allowed)0:

General Product Information 149Subject/Attribute Range Default Device DMS* Depends on available DMS settings.Patient ID entry mode 0: Keyboard / S

Introduction 15Important safety instructions and additional informationThis section explains how safety-related messages and information related to

General Product Information150Subject/Attribute Range Default Device DMSQC time of day 6 POCT1-A data elds 00:00 – 23:5906:00 09:00 12:00 15:00 18:00

General Product Information 151Subject/Attribute Range Default Device DMSDMS port (the port number to request open socket from the DMS. Roche reco

General Product Information152Subject/Attribute Range Default Device DMSWPA Key string of 64 characters (HEX)“0000000000 0000000000 0000000000 0000000

Appendix 153Allowed combinations of cipher and security typesecurity_type cipher_typewep_auth_typewep_keywpa_key_typewpa_keywpa_passphrase0 - open

Appendix154Operator and patient ID barcode masksBarcode mask character DenitionA-Z, 0-9 If not preceded by the Caret (“^”), the scan data character

Appendix 155B AppendixOption: Wireless network (WLAN)Preliminary noteAppendix B has been developed to explain the wireless communication protocol

Appendix156The ACCU-CHEK Inform II meter uses a burst-like commu nication protocol that will only consume bandwidth if there is actually data to be tr

Appendix 157The current RF card consists of an antenna and a WLAN system-on-chip (SoC) along with other components. The WLAN system-on-chip is the

Appendix158RF specic functionalities and effective performance claimsThe ACCU-CHEK Inform II system includes an optional module for wireless network

Appendix 159n An ACCU-CHEK Inform II meter with an RF card and wireless enabled will communicate results after every test or, when the meter is i

Introduction16Important information regarding safetyOperator qualication Only trained healthcare professionals may operate the ACCU-CHEK Inform II s

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Supplement for Other Test Entry 161C Supplement for Other Test EntryBefore you startDescriptionThe Other Test Entry (OTE) feature is designed to

Supplement for Other Test Entry162Overview of Other Test EntryIntroductionThe Other Test Entry feature allows you to enter patient results for the fol

Supplement for Other Test Entry 163Entering patient test results using the Other Test Entry menu comprises of the following steps:n Enter the pat

Supplement for Other Test Entry164Recording Other Test EntriesThe following steps must be completed already:1 The meter is powered on. 2 You have en

Supplement for Other Test Entry 1655 Enter or select the Patient ID (see Chapter 3 for more information). Touch to proceed to the next screen.6

Supplement for Other Test Entry1668 Use the keypad or barcode scanner to enter the Fecal Card Lot number, and touch to proceed to the next screen. O

Supplement for Other Test Entry 16710 Use the keypad or the barcode scanner (if a barcode is available) to enter the Fecal Developer Lot number,

Supplement for Other Test Entry16812 Select the result of the Positive Control as acceptable or not acceptable by touching the appropriate button.13

Supplement for Other Test Entry 169Once the result(s) are entered, the Fecal Occult Pat. result screen is displayed.15 To change an entry or a re

Introduction 17Disposal of the systemWARNINGInfection by a potentially biohazardous instrument The ACCU-CHEK Inform II system or its components mus

Supplement for Other Test Entry170Recording Other Control Test EntriesIntroductionThe Other Control Test Entry feature allows you to enter liquid cont

Supplement for Other Test Entry 171Entering control test results using the Other Control Test Entry menu comprises of the following steps:n Selec

Supplement for Other Test Entry172The following steps must be completed already:1 The meter is powered on. 2 You have entered your operator ID.3 Yo

Supplement for Other Test Entry 1735 Use the keypad or the barcode scanner (if a barcode is available) to enter the Pregnancy Ctrl Lot number. To

Supplement for Other Test Entry1749 Use the keypad or the barcode scanner (if a barcode is available) to enter the Pregnancy Kit Lot number. Touch t

Supplement for Other Test Entry 17511 Select the result of the Control bar test as acceptable or not acceptable by touching the appropriate butto

Supplement for Other Test Entry176Warning screensThe meter may display self-explanatory warning or error screens at various times when entering Other

Supplement for Other Test Entry 177Reviewing Results for Other Test EntryThe Other Test Result screen displays all stored results. Results can be

Supplement for Other Test Entry1783 Touch or to scroll up or down in the list. The results are grouped by date.4 Touch an entry in the list to d

Supplement for Other Test Entry 1796 Touch Patient, if you wish to display results for a specic patient only. – If you touch Patient from the f

Introduction18Battery PackThe meter contains a rechargeable battery pack that begins charging as soon as it is placed in an active base unit (i.e., on

Supplement for Other Test Entry180Other Test Entry Conguration OptionsOther Test Entry options can only be congured using a DMS. The availability of

Supplement for Observed Test Sequence 181D Supplement for Observed Test SequenceObserved Test Sequence (OTS)The Observed Test Sequence (OTS) func

Supplement for Observed Test Sequence182Using the OTS functionA request for an Observed Test Sequence comes from the DMS.Patient Test Menu 12:48pm11/1

Supplement for Observed Test Sequence 183 Operator:1 Touch Glucose Test.Perform the patient test as usual. Once the test is completed, the obser

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Limited Warranty 185E Limited WarrantyACCU-CHEK® Inform II meter LIMITED WARRANTYRoche Diagnostics warrants to the original purchaser that the AC

Limited Warranty186IN NO EVENT SHALL ROCHE DIAGNOSTICS BE LIABLE TO THE PURCHASER OR ANY OTHER PERSON FOR ANY INCIDENTAL, CONSEQUENTIAL, INDIRECT, SPE

187IndexAAccessory boxOverview ...29Addresses (Roche) ...

188IIconsIdentication plate ...4Packaging ...

189SSafetyProtection against infection ...17User qualication ...17Safety inform

Introduction 19TouchscreenNOTICEnUse only your nger to touch the screen elements. Using a sharp-edged object (e.g., tip of a pen) can damage the

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ACCU-CHEK, ACCU-CHEK INFORM and COBAS are trademarks of Roche.Manufactured for and distributed in the U.S.A. by:Roche Diagnostics9115 Hague RoadIndia

2Manual version Revision date ChangesVersion 1.0 2012-10 New documentVersion 2.0 2013-02 Upgrade to FW 03.04; Revise critically ill statementVersion

Introduction20To avoid ESD, do not use the meter in a very dry environment, particularly one in which synthetic materials (e.g., carpets) are present

Introduction 21Radiofrequency radiation exposure informationGlossary: n “FCC” stands for “Federal Communications Commission” (USA).n “RSS” stands

Introduction22Roche supports industry wireless standards and recom mends using products that have Wi-Fi certication. This certication tests products

Introduction 23This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rule

Introduction24System componentsThe ACCU-CHEK Inform II system includes the following components and accessories: A MeterB Code key readerC Base uni

Introduction 25Overview of the meterThe meter has the following elements: 1 Test strip port Insert the test strip here.2 Touchscreen (touch-sens

Introduction26Overview 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

Introduction 27Overview of the base unitTo provide exibility in line with customer requirements, two versions of the base unit are available. n

Introduction28Electrical connections are located on the back of the base unit (for a better view the removable wall mount is shown as transparent). Fo

Introduction 29Instructions for initial setupThe meter must be congured prior to initial use. During this setup, the following parameters are con

©2013 Roche Diagnostics. All rights reserved. 05234646002 2013-03 USAACCU-CHEK ® Inform II SystemOperator’s Manual

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Powering Up and Entering an Operator ID 312 Powering Up and Entering an Operator IDPowering up the meter1 Press and release the On/Off button .

Powering Up and Entering an Operator ID32Adjusting the displayUsing the Display options, you can adjust display param eters to your needs: n Adjust

Powering Up and Entering an Operator ID 33Enabling/disabling the RF cardIf the unit is equipped with an RF card, you can temporarily enable or dis

Powering Up and Entering an Operator ID34Closing startupOnce you have completed all the necessary changes,n touch to proceed to the screen used to

Powering Up and Entering an Operator ID 35Entering an operator ID with barcode scannerWhen the screen for entering the operator ID is dis played:1

Powering Up and Entering an Operator ID36Entering the operator ID manuallyWhen the screen for entering the operator ID is displayed:1 Touch the lett

Patient Glucose Testing 373 Patient Glucose Testing Information regarding blood glucose testingBefore performing a blood glucose test, observe t

Patient Glucose Testing 38Preparing to testFor more detailed information regarding the ACCU-CHEK Inform II test strip, refer to the package insert fo

Patient Glucose Testing 39Performing a patient glucose testOverview of test procedureA patient glucose test comprises the following steps: n Ent

4©2013, Roche Diagnostics. All rights reserved.The contents of this document, including all graphics, are the property of Roche Diagnostics. Informat

Patient Glucose Testing 40You now have three different options, depending on setup, for assigning the subsequent test to a patient.The patient ID func

Patient Glucose Testing 41Entering the patient ID manuallyUse the displayed keypad to enter the patient ID. You can select characters in the same

Patient Glucose Testing 42Selecting the patient ID from alistChoose the patient ID from a list*, if a list has been down loaded to the meter (from th

Patient Glucose Testing 43Entering a patient ID with barcode scannerWhen the screen for entering the patient ID is displayed:1 Press and release

Patient Glucose Testing 44Conrming or selecting the test strip lotOnce you have entered and conrmed the patient ID, you are asked to choose the lot

Patient Glucose Testing 45Inserting test stripsAfter conrming the test strip lot, you are prompted to insert the test strip.1 Remove the test s

Patient Glucose Testing 46Applying a blood sampleOnce the meter has detected the test strip, you are prompted to apply a blood sample. 1 Wait until t

Patient Glucose Testing 47Results screenThe hourglass icon indicates the test is running. When the test is completed and the result is ready, the

Patient Glucose Testing 48n The System Measurement Range refers to the measurement range of the system itself (test strips and meter) and is the only

Patient Glucose Testing 49The following messages may appear in addition to the standard test result:n CR LO (below the Critical Range threshold,

51 Introduction 11Before you start ...

Patient Glucose Testing 50Adding commentsYou can add up to a total of three comments to a test result. Com ments can provide, for example, additional

Glucose Control Testing 514 Glucose Control TestingInformation regarding glucose control testsObserve the applicable regulations and directives o

Glucose Control Testing52Glucose control testing intervalsIntervals between running glucose control tests are determined by your facility. These inter

Glucose Control Testing 53Information stored during glucose control testingThe following information is stored for every glucose con trol test usi

Glucose Control Testing54Performing glucose control testsOverview of test procedureA glucose control test using control solution comprises the followi

Glucose Control Testing 55Starting a glucose control testAfter preparing the meter as described, you can proceed to the steps directly related to

Glucose Control Testing56Conrming or selecting the lot number for control solutionsOnce you have selected the level, you are asked to con rm or ente

Glucose Control Testing 57Conrming or selecting the test strip lotOnce you have entered and conrmed the lot number of the control solution, you

Glucose Control Testing58Inserting test stripsAfter conrming the test strip lot, you are prompted to insert the test strip.1 Remove the test strip f

Glucose Control Testing 59Applying the control solutionOnce the meter has detected the test strip, you are prompted to apply the control solution.

63 Patient Glucose Testing 37Information regarding blood glucose testing ...

Glucose Control Testing60Results screenThe hourglass icon indicates the test is running. When the test is completed and the result is ready, the meter

Glucose Control Testing 61Performing a STAT testThe meter can be congured to allow a STAT patient glu cose test to be run even if the meter is in

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Review Results 635 Review Results Displaying test results from the memoryInformation stored in data records for test resultsWhen you retrieve th

Review Results 643 Touch an entry in the list to display the related details.4 Touch Patient, if you wish to display results for a specic patient o

Storing Test Strip, Control Solution, and Linearity Solution Information in the Meter 656 Storing Test Strip, Control Solution, and Linearity So

Storing Test Strip, Control Solution, and Linearity Solution Information in the Meter 66Transferring code key information to the meterThe following de

Storing Test Strip, Control Solution, and Linearity Solution Information in the Meter 675 Place the code key reader on a level surface such as a

Storing Test Strip, Control Solution, and Linearity Solution Information in the Meter 68Information about the expiration date and parameters for contr

Storing Test Strip, Control Solution, and Linearity Solution Information in the Meter 69The parameters for control solutions consist of four sepa

76 Storing Test Strip, Control Solution, and Linearity Solution Information in the Meter 65Storing information about test strips ...

Storing Test Strip, Control Solution, and Linearity Solution Information in the Meter 70Once you have nished updating the test strip information, you

Storing Test Strip, Control Solution, and Linearity Solution Information in the Meter 71Storing control solution informationGlucose control solut

Storing Test Strip, Control Solution, and Linearity Solution Information in the Meter 724 Select the level (L1/Lo or L2/Hi).5 Use the keypad to ente

Storing Test Strip, Control Solution, and Linearity Solution Information in the Meter 73Once you have nished updating the control solution infor

Storing Test Strip, Control Solution, and Linearity Solution Information in the Meter 74Selecting a stored lot number as the current lot numberYou can

Storing Test Strip, Control Solution, and Linearity Solution Information in the Meter 753 Touch the lot number you wish to select as the current

Storing Test Strip, Control Solution, and Linearity Solution Information in the Meter 76Storing linearity test informationObserve the applicable regul

Storing Test Strip, Control Solution, and Linearity Solution Information in the Meter 774 Use the keypad to enter the linearity lot number.5 To

Storing Test Strip, Control Solution, and Linearity Solution Information in the Meter 78Selecting a stored lot number as the current lot numberYou can

Storing Test Strip, Control Solution, and Linearity Solution Information in the Meter 793 Touch the linearity lot number you wish to select as t

89 Initial Startup 97Connecting the base unit ...

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Linearity Testing 817 Linearity Testing Information regarding linearity testsObserve the applicable regulations and directives of the responsibl

Linearity Testing 82Information stored during linearity testingThe following information is stored for every linearity test:n Test resultn Lot numbe

Linearity Testing 83Performing a linearity testOverview of test procedureA linearity test comprises the following steps: n Check the lot number

Linearity Testing 84Conrming or selecting the lot number for linearity test kitsYou are now prompted to conrm or enter the lot number of the lineari

Linearity Testing 85In the Linearity Test menu, the levels available for the lin earity test are displayed. 4 Touch L1 to start the subsequent t

Linearity Testing 86Applying a linearity test sampleOnce the meter has detected the test strip, you will be prompted to apply the linearity solution.

Linearity Testing 87Results screenThe hourglass icon indicates the test is running. When the test is completed and the result is ready, the meter

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Prociency Testing 898 Prociency TestingInformation regarding prociency testsObserve the applicable regulations and directives of the responsib

911 Troubleshooting 133Errors and unusual behavior without error messages ...133Error messag

Prociency Testing90Information stored during prociency testingThe following information is stored for every prociency test:n Test resultn Sample

Prociency Testing 91Performing a prociency testOverview of test procedureA prociency test comprises the following steps: n Enter a sample ID f

Prociency Testing92Entering the prociency sampleIDYou will now be asked to enter the sample ID. 1 Use the keypad to manually enter the sample ID,

Prociency Testing 93Inserting test stripsAfter conrming the test strip lot, you will be prompted to insert the test strip.1 Remove the test str

Prociency Testing94Applying a prociency sampleOnce the meter has detected the test strip, you are prompted to apply the prociency sample. 1 Wait u

Prociency Testing 95Results screenThe hourglass icon indicates the test is running. When the test is completed and the result is ready, the meter

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Initial Startup 979 Initial StartupConnecting the base unitNOTICETo ensure continuous safe and reliable operation, use only the power supply unit

Initial Startup98Installing or replacing the battery packWhen shipped, the battery pack is not installed in the ACCU-CHEK Inform II meter. After insta

Initial Startup 99Removing the battery pack1 If a battery pack is already installed, make sure that the meter is switched off.2 Place the meter