Accu-Chek Inform II System Operators Manual Ver 3.0 March 2013



Manual version Version 1.0 Version 2.0

Revision date 2012-10 2013-02

Version 3.0

2013-03

2

Changes New document Upgrade to FW 03.04; Revise critically ill statement Update cleaning and disinfecting chapter

ACCU-CHEK Inform II System ®

Operator’s Manual

©2013 Roche Diagnostics. All rights reserved.

05234646002 2013-03 USA

 ©2013, Roche Diagnostics. All rights reserved. The contents of this document, including all graphics, are the property of Roche Diagnostics. Information in this document is subject to change without notice. Roche Diagnostics shall not be liable for technical or edi­torial errors or omissions 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, ACCU-CHEK INFORM and COBAS are trademarks of Roche. All other trademarks are the property of their respective owners. The Wi-Fi CERTIFIED Logo is a certification mark of the Wi-Fi Alliance. On the packaging, on the identification plate of the meter, the battery pack, the base unit, or the code key reader you may encounter the following symbols, shown here with their meaning:

Caution, consult accompanying documents. Refer to safety-related notes in the instruction for use accompanying this instrument. Temperature limitation (Store at) Manufacturer Catalog number In vitro diagnostic medical device

IVD

This product fulfills the requirements of the European Directives 98/79/EC on in vitro ­diagnostic medical devices and 1999/5/EC on radio and telecommunications terminal equipment (R&TTE). This device complies with Part 15 of the FCC Rules and with RSS-210 of Industry Canada. The compliance mark indicates that the product complies with the applicable standard and establishes a traceable link between the equipment and the manufacturer, importer or their agent responsible for compliance and for placing it on the Australian and New Zealand market. The system fulfills the Canadian and U.S. safety requirements (UL LISTED, in accordance with UL 61010A-1:02 and CAN/CSA-C22.2 No. 61010-1-04). 7.5V

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1.7A

Power supply connection

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Introduction 11 Before you start...11 Intended use...11 Important information regarding use...12 If you need help...13 Note on the use of “base unit” in this manual...13 Note on illustrations in this manual...13 What can the system do for you?...14 Important safety instructions and additional information...15 Important information regarding safety...16 Disposal of the system...17 Product safety...17 General care...17 Accessory box...17 Meter...17 Battery Pack...18 Touchscreen...19 Laser scanner...19 Electrostatic discharge (ESD)...19 Local Area Network: protection from unauthorized access...20 Wired network connection (RF card)...20 Wireless network connection (RF card)...20 Radiofrequency radiation exposure information...21 System components...24 Overview of the meter...25 Overview of the code key reader...26 Overview of the base unit...27 Overview of the accessory box...28 Reagents and consumables...28 Instructions for initial setup...29

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Powering Up and Entering an Operator ID 31 Powering up the meter...31 Adjusting the display...32 Enabling/disabling the RF card...33 Closing startup...34 Entering the operator ID...34 Entering an operator ID with barcode scanner...35 Entering the operator ID manually...36 Entering a password...36

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Patient Glucose Testing 37 Information regarding blood glucose testing...37 Preparing to test...38 Performing a patient glucose test...39 Overview of test procedure...39 Entering or selecting the patient ID...39 Entering the patient ID manually...41 Selecting the patient ID from a list...42 Entering a patient ID with barcode scanner...43 Confirming or selecting the test strip lot...44 Inserting test strips...45 Applying a blood sample...46 Results screen...47 Adding comments...50

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Glucose Control Testing 51 Information regarding glucose control tests...51 Glucose control testing intervals...52 Information stored during glucose control testing...53 Control solutions...53 Preparing to run a glucose control test...53 Performing glucose control tests...54 Overview of test procedure...54 Starting a glucose control test...55 Confirming or selecting the lot number for control solutions...56 Confirming or selecting the test strip lot...57 Inserting test strips...58 Applying the control solution...59 Results screen...60 Performing a STAT test...60

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Review Results 63 Displaying test results from the memory...63 Information stored in data records for test results...63 List of results stored in the memory...63

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Storing Test Strip, Control Solution, and Linearity Solution Information in the Meter 65 Storing information about test strips...65 Transferring code key information to the meter...66 Editing test strip data...68 Storing control solution information...70 Entering the lot number of the control solution...70 Selecting a stored lot number as the current lot number...74 Storing linearity test information...76 Entering the lot number of the linearity test...76 Selecting a stored lot number as the current lot number...78

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Linearity Testing 81 Information regarding linearity tests...81 Linearity testing intervals...81 Information stored during linearity testing...82 Linearity test kit...82 Preparing to run a linearity test...82 Performing a linearity test...83 Overview of test procedure...83 Starting a linearity test...83 Confirming or selecting the lot number for linearity test kits...84 Confirming or selecting the test strip lot...84 Inserting test strips...85 Applying a linearity test sample...86 Results screen...87

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Proficiency Testing 89 Information regarding proficiency tests...89 Information stored during proficiency testing...90 Preparing a proficiency test...90 Performing a proficiency test...91 Overview of test procedure...91 Starting a proficiency test...91 Entering the proficiency sample ID...92 Confirming or selecting the test strip lot...92 Inserting test strips...93 Applying a proficiency sample...94 Results screen...95

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Initial Startup 97 Connecting the base unit...97 Installing or replacing the battery pack...98 Removing the battery pack...99 Installing the battery pack...100 Docking the meter...103 Initial setup on the meter...105 Menu overview...106 Opening the Setup Menu...109 Date and time format...110 Display options and optional tests...111 Options for test strips...112 Options for glucose control tests...114 Value ranges (normal, critical, reportable)...115 Options for Operator ID Entry...116 Patient ID options...117 Creating a setup password...118 Setting the date and time...119 Beeper options...120 Diagnostics view...121 Unlocking a Download Lockout...122

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Maintenance and Care 123 Conditions for storage and shipping...123 General operating conditions...123 Storage...124 Cleaning and disinfecting the ACCU-CHEK Inform II system...124 Guide to cleaning and disinfecting the ACCU-CHEK Inform II system...125 Cleaning and disinfecting the meter...125 Acceptable cleaning / disinfecting agents...126 What to clean / disinfect...127 Technical Assistance...127 How to clean and disinfect the ACCU-CHEK Inform II system...128 Cleaning the meter...129 Disinfecting the meter...130 Logging maintenance activities...130

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Troubleshooting 133 Errors and unusual behavior without error messages...133 Error messages...137 Meter reset...139

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General Product Information 141 Technical data...141 Further Information...143 Ordering...143 Accu-Chek Inform II Operator’s Manual and Quick Reference Guide...143 Reagents and Solutions...143 Information about software licenses...144 Contact Roche...144

A

Appendix 145 Table of configuration options...145 Example of barcode symbologies...154

B

Appendix 155 Option: Wireless network (WLAN)...155 Preliminary note...155 Background...155 Technical implementation...156 Location and type of RF card...157 RF specific functionalities and effective performance specifications...158

C

Supplement for Other Test Entry 160 Before you start...160 Description...160 Overview of Other Test Entry...162 Introduction...162 Recording Other Test Entries...164 Recording Other Control Test Entries...170 Introduction...170 Other Control Testing Intervals...170 Stored Control Information...170 Warning screens...176 Reviewing Results for Other Test Entry...177 Other Test Entry Configuration Options...180

D

Supplement for Observed Test Sequence 181 Observed Test Sequence (OTS)...181 Using the OTS function...182

E

Limited Warranty 185 ACCU-CHEK Inform II Limited Warranty...185 Index

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Introduction

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Introduction

Before you start Intended use

The ACCU-CHEK® Inform II test strips are for use with the ACCU-CHEK Inform II meter to quantitatively measure glucose (sugar) in venous whole blood, arterial whole blood, heel stick neonatal, or fresh capillary whole blood samples drawn from the fingertips as an aid in monitoring the effectiveness of glucose control. The system is not for use in diagnosis or screening of diabetes mellitus, nor for testing neonate cord blood samples. The ACCU-CHEK Inform II Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple patient use in professional healthcare settings. This system should only be used with single-use, auto-disabling lancing devices. The multiple-patient use ACCU-CHEK Inform II Blood Glucose Monitoring System will consist of: • Meter: ACCU-CHEK Inform II Meter • Test Strip: ACCU-CHEK Inform II Test Strip • Controls: ACCU-CHEK Inform II Control Solutions • Linearity: ACCU-CHEK Linearity Kit

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Introduction Important information regarding use

Read this operator’s manual, as well as the package inserts for all relevant consumables, before using the system for the first test. You must configure the ACCU-CHEK Inform II system according to your needs before initial use. You can con­figure the system either directly on the meter or by using a suitable data management system. Refer to Chapter 9 “Initial setup on the meter” for on-meter configuration. Refer to Appendix A for configuration via a data manage­ment system. Be sure to read the “Important safety instructions and additional information” section in this chapter before operating the system. The FDA, CDC, and CMS recommend that Point of Care blood testing devices such as the ACCU-CHEK Inform II meter should be used only on one patient and not shared. If dedicating blood glucose meters to a single patient is not possible, the meters must be properly cleaned and dis­infected after every use following the guidelines provided in this manual (see section “Maintenance and Care”).3

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Introduction If you need help

Information about using the system, the screen menus and performing a test can be found in this operator’s manual. Error messages that appear on-screen include information or instructions on how to correct the error. For all questions about the ACCU-CHEK Inform II system that are not answered in this manual, contact the ACCU-CHEK Customer Care Service Center at 1-800-440-3638 24 hours a day, 365 days a year. In order to expedite troubleshooting, please have ready your ACCU-CHEK Inform II meter, its serial number, this manual, and all related consumables when you call. If you suspect a communication error beyond the meter, also have your ACCU-CHEK Inform II Base Unit serial number ready to help assist our customer care group in troubleshooting.

Note on the use of “base unit” in this manual Unless otherwise specified, the term “base unit” refers to both the ACCU-CHEK Inform II Base Unit and the ACCU-CHEK Inform II Base Unit Light. Note on illustrations in this manual Illustrations 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.

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Introduction What can the system do for you?

The ACCU-CHEK Inform II system has the following fea­tures and properties: n

Perform patient blood glucose tests and glucose control tests with control solution.

n

Automatically record all relevant data for the application, which includes: – Time and date of test – IDs for operator, patient, and samples – Information about control solutions, test strips, and linearity – Test results and comments

n

Record patient test results, quality control test results and reagent information for certain off-meter manual tests.

n

For purposes of quality assurance, information on the following areas can be collected, stored, and transferred: – Meters – Test strips – Glucose control solutions – Linearity solutions – Test results

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Introduction

Important safety instructions and additional information This section explains how safety-related messages and information related to the proper handling of the system are presented in this ACCU-CHEK Inform II manual. Please read these p ­ assages carefully. The safety alert symbol alone (without a signal word) promotes awareness 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

Indicates a hazardous situation which, if not avoided, could result in minor or moderate injury.

CAUTION

NOTICE

NOTICE

Indicates a hazardous situation which, if not avoided, may result in damage to the system.

Important information that is not safety relevant is presented against a colored background (without a symbol). Here you will find additional information on correct use of the meter or useful tips.

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Introduction Important information regarding safety Operator qualification Only trained healthcare professionals may operate the ACCU-CHEK Inform II system. Operators must also have received comprehensive instruction in the operation, quality control, and care of the ACCU-CHEK Inform II ­system.

WARNING

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Protection against infection and blood-borne pathogens Healthcare professionals using the ACCU-CHEK Inform II system to perform tests on more than one patient must be aware that any object coming into contact with human blood is a potential source of infection. Operators need to adhere to Standard Precautions when handling or using the ACCU-CHEK Inform II system. All parts of this system should be considered potentially infectious and are capable of transmitting blood-borne pathogens between patients and healthcare professionals. n Use gloves. Wear a new pair of clean gloves for testing each patient. n Wash hands thoroughly with soap and water before putting on a new pair of gloves and performing the next patient test. n Use an auto-disabling single-use lancing device for each patient. n Dispose of used lancets in a sturdy sharps container with lid. n Dispose of used test strips from patient and ­proficiency tests according to your institution’s infection control policy. n Follow all health and safety regulations in force locally. n For more information, refer to the following practice guidelines: –– “Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings 2007”, http://www.cdc.gov/hicpac/2007ip /2007isolationprecautions.html. –– “Biosafety in Microbiological and Biomedical Laboratories (BMBL)” found at http://www.cdc. gov/biosafety/publications/bmbl5/ –– “Protection of Laboratory Workers From Occupationally Acquired Infections; Approved Guideline-Third Edition” Clinical and Laboratory Standards Institute (CLSI) M29-A3.

Introduction Disposal of the system

WARNING

Infection by a potentially biohazardous instrument The ACCU-CHEK Inform II system or its components must be treated as potentially biohazardous waste. Decontamination (i.e., a combination of processes including 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 or you may return it to Roche. For more information, call your local Roche representative or contact ACCU-CHEK Customer Care.

Product safety

Observe the following information to ensure product safety: n

The system is suitable for continuous operation.

NOTICE

The system is not protected against the harmful ingress of fluids (IP X0 rating according to IEC 60529).

NOTICE

To avoid damaging the system, use only solutions recommended to clean and disinfect the system. Using other solutions may result in incorrect operation and possible failure of the system.

NOTICE

Carry the accessory box carefully by the handle for easy transport. Dropping or hitting the box may damage it.

General care

Accessory box

Meter n

Unless otherwise configured, the system automatically powers down after 5 minutes of inactivity (i.e., no screen touches).

n

Dispose of the meter in accordance with applicable laws and regulations.

n

In Measurement mode only: If you are performing a test (patient, control, proficiency or linearity), the meter will power off after 10 minutes of inactivity (no screen touches), independently of configured automatic power off time. If a result is already present, the meter will emit three warning beeps every minute after 5 minutes of inactivity and will save the result before powering off after 10 minutes of activity.

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Introduction Battery Pack

The meter contains a rechargeable battery pack that begins charging as soon as it is placed in an active base unit (i.e., one connected to a power supply). NOTICE

Use only the specially designed battery pack provided by Roche Diagnostics. Using any other type of battery may damage the system. Observe the following general safety instructions for han­dling battery pack: Do not dispose of the battery pack with normal domestic waste. As a component of the ACCU-CHEK Inform II sys­tem, it must be deemed as potentially biohazardous. Treat it accordingly. See “Disposal of the system” on page 17. n

When storing or disposing of the battery pack, use the manufacturer’s original packaging.

Save or download data from the meter prior to replacing the battery pack to prevent loss of data (see Chapter 9).

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n

Always power off the meter before removing the battery pack.

n

When the Battery Low warning is displayed, the meter must be returned as soon as possible to the base unit for recharging.

n

The Battery Critically Low warning indicates that the meter must be returned immediately to the base unit for recharging. No more tests can be performed.

Introduction Touchscreen NOTICE

Laser scanner

Use only your finger to touch the screen elements. Using a sharp-edged object (e.g., tip of a pen) can damage the touchscreen. n Do not use the system in direct sunlight. Direct sunlight may reduce the life expectancy and functionality of the display, as well as the integrity of test strips.

n

The built-in barcode scanner emits a laser beam when activated. The built-in barcode scanner is a Class 1 laser, according to IEC 60825-1/A2:2001.

WARNING

Electrostatic discharge (ESD)

A barcode does not need to be present for the laser scanner to become active. Do not stare directly into the laser beam.

The ACCU-CHEK Inform II system complies with both the electromagnetic immunity requirements and radio inter­ference immunity requirements at the frequency and test levels according to EN ISO 15197 Annex A. The system also complies with the electrostatic discharge (ESD) immunity requirements as specified in IEC 61000-4-2 and complies with applicable electromagnetic emissions (EMC) requirements according to EN 61236. The system’s emissions of the energy used are low and not likely to cause interference in nearby electronically driven equip­ment. Electrostatic discharge (ESD) is an electrical charge at rest, most commonly known as static electricity. If the ACCU-CHEK Inform II meter experiences a form of ESD before or after running a blood glucose test, the test result will be stored in the meter memory and transmitted when the meter is docked in a connected base unit or when a wireless connection is established. If the meter experiences ESD during a blood glucose test, an error message is displayed and no blood glucose result is dis­played by the meter or stored in the meter’s memory. The blood glucose test will need to be repeated.

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Introduction To avoid ESD, do not use the meter in a very dry environment, particularly one in which synthetic materials (e.g., carpets) are present that might cause damaging static discharges, or near electronic equipment that is a source of electromagnetic radiation. Local Area Network: protection from unauthorized access

Wired network connection

Wireless network connection (RF card)

If this product is connected to a local area network, this network must be protected against unauthorized access. In particular, it must not be linked directly to any other network or the Internet. Customers are responsible for the security of their local area network, especially in protecting it against malicious software and attacks. This protection might include meausres, such as a firewall, to separate the device from uncontrolled networks as well as measures that ensure that the connected network is free of malicious code. If connected to a local area network, the ACCU-CHEK Inform II Base Unit or ACCU-CHEK Inform II Base Unit HUB must be protected against unauthorized access. For additional information about the ACCU-CHEK Inform II Base Unit or ACCU-CHEK Inform II Base Unit HUB, refer to the ACCU-CHEK Inform II Base Unit HUB Operator’s Manual.

The optional RF card for a wireless network connection allows the meter to send data (test results, patient IDs, operator IDs, etc.) to the data management system with­out the need to return the meter to the base unit. This feature must be configured by the system administrator. Observe the guidelines of your facility for using wireless local area network connections. For information about how to temporarily enable or disable this function, see page 33. For a description of the ACCU-CHEK Inform II meter’s ability to connect to Wireless Local Area Net­works (WLAN, Wi-Fi), see appendix B.

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