Accu-Chek Inform II Operators Manual Ver 3.0 Sept 2010

Manual version

Revision date

Version 1.0

2008-01

New document

Version 2.0

2009-08

Update, new SW version 02.00

Version 3.0

2010-09

Update, new SW version 03.00

2

Changes

ACCU-CHEK Inform II System ®

Operator’s Manual

©2010 Roche Diagnostics. All rights reserved.

0 4807839001 (03) 2010-09 EN

©2010, 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, ACCU-CHEK PERFORMA and COBAS are trademarks of Roche. All other trademarks are the property of their respective owners. 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 manual 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 61010-1 and CAN/CSA-C22.2 No. 61010-1) 7.5V

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1.7A

Power supply connection

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Introduction 9 Before you start... 9 Intended use ... 9 Important information regarding use ... 9 If you need help ... 10 Note on the use of “base unit” in this manual... 10 Note on illustrations in this manual ... 10 What can the system do for you? ... 11 Safety information and additional information ... 12 Important information regarding safety... 13 Disposal of the system ... 13 Product safety... 14 General care... 14 Accessory box ... 14 Meter ... 14 Battery Pack ... 15 Touchscreen... 16 Laser scanner ... 16 Wireless network connection (RF card) ... 16 Radiofrequency radiation exposure information... 17 Note on systems with older hardware ... 19 System components... 21 Overview of the meter ... 22 Overview of the code key reader ... 23 Overview of the base unit ... 24 Overview of the accessory box ... 25 Reagents and consumables... 25 Instructions for initial setup... 26

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Powering Up and Entering an Operator ID 27 Powering up the meter ... 27 Adjusting the display ... 28 Adjusting the display on meters with older hardware ... 28 Enabling/disabling the RF card... 29 Closing startup ... 30 Entering the operator ID... 30 Entering an operator ID with barcode scanner ... 31 Entering the operator ID manually ... 32 Entering a password ... 32

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Patient Glucose Testing 33 Information regarding blood glucose testing ... 33 Preparing to test ... 33 Performing a patient glucose test... 34 Overview of test procedure ... 34 Entering or selecting the patient ID ... 34 Entering the patient ID manually... 36 Selecting the patient ID from a list... 37 Entering a patient ID with barcode scanner ... 38 Confirming or selecting the test strip lot... 39 Inserting test strips ... 40 Applying a blood sample... 41 Results screen ... 42 Adding comments... 45

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Glucose Control Testing 47 Information regarding glucose control tests... 47 Glucose control testing intervals... 48 Information stored during glucose control testing... 49 Control solutions... 49 Preparing to run a glucose control test ... 49 Performing glucose control tests ... 50 Overview of test procedure ... 50 Starting a glucose control test ... 51 Confirming or selecting the lot number for control solutions ... 52 Confirming or selecting the test strip lot... 53 Inserting test strips ... 54 Applying the control solution... 55 Results screen ... 56 Performing a STAT test ... 57

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Review Results 59 Displaying test results from the memory ... 59 Information stored in data records for test results... 59 List of results stored in the memory... 59

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Storing Test Strip, Control Solution, and Linearity Solution Information in the Meter 61 Storing information about test strips ... 61 Transferring code key information to the meter... 62 Editing test strip data... 64 Storing control solution information ... 67 Entering the lot number of the control solution ... 67 Selecting a stored lot number as the current lot number... 70 Storing linearity test information ... 72 Entering the lot number of the linearity test ... 72 Selecting a stored lot number as the current lot number... 74

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Linearity Testing 77 Information regarding linearity tests... 77 Linearity testing intervals ... 77 Information stored during linearity testing... 78 Linearity test kit ... 78 Preparing to run a linearity test ... 78 Performing a linearity test... 79 Overview of test procedure ... 79 Starting a linearity test ... 79 Confirming or selecting the lot number for linearity test kits... 80 Confirming or selecting the test strip lot... 80 Inserting test strips ... 81 Applying a linearity test sample ... 82 Results screen ... 83

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Proficiency Testing 85 Information regarding proficiency tests ... 85 Information stored during proficiency testing... 86 Preparing a proficiency test ... 86 Performing a proficiency test... 87 Overview of test procedure ... 87 Starting a proficiency test ... 87 Entering the proficiency sample ID ... 88 Confirming or selecting the test strip lot... 88 Inserting test strips ... 89 Applying a proficiency sample... 90 Results screen ... 91

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Initial Startup 93 Connecting the base unit... 93 Installing or replacing the battery pack... 94 Removing the battery pack ... 95 Installing the battery pack ... 96 Docking the meter... 99 Initial setup on the meter ... 101 Menu overview... 102 Opening the Setup Menu ... 105 Date and time format... 106 Display options and optional tests ... 107 Options for test strips ... 108 Options for glucose control tests... 110 Value ranges (normal, critical, reportable)... 111 Options for Operator ID Entry... 112 Patient ID options... 113 Creating a setup password... 114 Setting the date and time... 115 Beeper options ... 116 Diagnostics view... 117 Unlocking a Download Lockout... 118 7

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Maintenance and Care 119 Conditions for storage and shipping ... 119 General operating conditions ... 119 Storage ... 120 Cleaning... 120 Cleaning agents... 120 Cleaning the meter ... 121 Cleaning the barcode scanner window ... 121 Cleaning the base unit ... 122 Cleaning the accessory box ... 123 Disinfecting... 124 Disinfecting the meter... 125 Disinfecting the base unit ... 127 Disinfecting the accessory box ... 128 Logging maintenance activities... 129

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Troubleshooting 131 Errors and unusual behavior without error messages ... 131 Error messages... 134 Meter reset ... 136

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General Product Information 137 Technical data ... 137 Further Information... 139 Ordering ... 139 Accu-Chek Inform II Operator’s Manual and Quick Reference Guide... 139 Reagents and Solutions ... 139 Information about software licenses... 140 Contact Roche... 140

A

Appendix 141 Table of configuration options ... 141 Example of barcode symbologies ... 150

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Appendix 151 Option: Wireless network (WLAN)... 151 Application area... 151 Functions enabled with wireless connectivity ... 151 Index

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Introduction

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Introduction

Before you start Intended use

The Accu-Chek® Inform II system is intended for in vitro diagnostic use in the quantitative determination of blood glucose levels in venous, capillary, arterial, and neonatal whole blood samples for monitoring blood glucose. The system is indicated for use by healthcare professionals. For healthcare professionals, the system is a bedside unit that can help you provide quality patient care by measuring blood glucose and by automating the record keeping associated with blood glucose and glucose control tests.

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 “Safety information and additional information” section in this chapter before operating the system.

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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 your Roche representative (see Chapter 12). 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: ■

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

■

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

■

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

Safety information and additional information This section explains how safety-related messages and information related to the proper handling of the system are presented in the Accu-Chek Inform II manual. Please read these passages carefully. The safety alert symbol by itself (without a signal word) is used to promote awareness to hazards which are generic or to direct the reader to related safety information

WARNING

CAUTION NOTICE

Indicates a hazardous situation which, if not avoided, could result in death or serious injury.

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

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

Protection against infection There is a potential risk of infection. 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. ■

Use gloves.

■

Use a separate lancet / separate lancing device for each patient.

■

Dispose of used lancets in a sturdy sharps container with lid.

■

Dispose of used test strips from patient and proficiency tests according to your institution’s infection control policy.

■

Follow all health and safety regulations in force locally.

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, contact your Roche representative.

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Introduction Product safety

Observe the following information to ensure product safety: ■

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

Clean the system only with the solutions recommended. Using other solutions may result in incorrect operation and possible failure of the system. Make sure that the meter and base unit are thoroughly dried after cleaning or disinfecting.

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

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■

Unless otherwise configured, the system automatically powers down after 10 minutes of inactivity (i.e., no screen touches).

■

Dispose of the meter in accordance with applicable laws and regulations. See “Disposal of the system” on page 13.

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 batteries: 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 13. ■

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).

■

Always turn off the meter before removing the battery pack.

■

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

■

The Battery Critically Low warning indicates that the meter must be returned immediately to the base unit for recharging.

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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.

■

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.

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

Wireless network connection (RF card)

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

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. The device conforms with the Wireless Local Area Network (WLAN) standard IEEE 802.11g. 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 29.

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Introduction Radiofrequency radiation exposure information Glossary: “FCC” stands for “Federal Communications Commission” (USA). ■ “RSS” stands for “Radio Standards Specification” (Canada) ■

Note: The following table provides an overview of the classifications for electromagnetic compliance (EMC, according to CISPR 11) for different combinations of Accu-Chek Inform II system components. Refer to the explanatory texts following the table for more information on these classifications. Classification acc. to CISPR 11

Meter with RF, docked, serial number < UU11030000

Meter with RF, docked, serial number ≥ UU11030000

Accu-Chek Inform II Base Unit, serial Class A number < UU41030000 and connected to network / a PC via a cable

Not allowed

Accu-Chek Inform II Base Unit, serial Class B number ≥ UU41030000

Class B

No operating limitations apply to meters without an RF card or to meters with an RF card that are not docked. Note: The following Classification B applies to all hardware combinations except those specified on page 19. This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment. This equipment should be installed and operated with minimum distance of 20 cm (8 inches) between the radiator and your body. This transmitter must not be co-located or operated in conjunction with any other antenna or transmitter. Changes or modifications made to this equipment not expressly approved by Roche Diagnostics may void the FCC authorization to operate this equipment. 17

Introduction This device complies with Part 15 of the FCC Rules and with RSS-210 of Industry Canada. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. The Accu-Chek Inform II system complies with the emission and immunity requirements described in IEC 613262-6:2006. It has been designed and tested to CISPR 11 Class B. This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: ■

Reorient or relocate the receiving antenna.

■

Increase the separation between the equipment and receiver.

■

Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.

■

Consult the dealer or an experienced radio/TV technician for help.

This Class B digital apparatus complies with Canadian ICES-003.

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Introduction Note on systems with older hardware

WARNING

Possibility of Electromagnetic Interference Under certain conditions, a specific combination of hardware equipment may emit electromagnetic radiation of such high energy that it can interfere with the proper functioning of other electronic or medical equipment. Therefore it is not allowed to dock an Accu-Chek Inform II meter with a serial number above or equal to UU11030000, which is equipped with an RF card, into an Accu-Chek Inform II Base Unit with a serial number below UU41030000 if this Accu-Chek Inform II Base Unit is connected to a network directly or through a PC via a cable. Note: The following classification applies if an Accu-Chek Inform II meter (with RF card) with a serial number below UU11030000 is docked in an Accu-Chek Inform II Base Unit with a serial number below UU41030000 if this Accu-Chek Inform II Base Unit is connected to a network directly or through a PC via a cable. The Accu-Chek Inform II system complies with the emission and immunity requirements described in IEC 613262-6:2006. It has been designed and tested to CISPR 11 Class A. In a domestic environment it may cause radio interference, in which case, you may need to take measures to mitigate the interference. The electromagnetic environment in which the Accu-Chek Inform II device is to be operated should be thoroughly evaluated prior to operation of the device.

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Introduction This 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. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instruction manual, may cause harmful interference to radio communications. Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at his own expense. This Class A digital apparatus complies with Canadian ICES-003.

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