Roche Accu-Chek Inform II Operator's Manual
Accu-Chek® Inform II
BLOOD GLUCOSE MONITORING SYSTEM
Operator’s Manual
Revision History
Manual version Revision date Changes
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
Version 4.0 2012-11 Update, new SW version 03.04 (OTS, OTE), revision
Cleaning/Disinfection section; misc. editorial revisions
Version 5.0 2013-09 Transition to new meter hardware: 2D barcode scan-
ner, modifications to wireless LAN option (separate
insertable RF card replaced by integrated WLAN component); new battery pack. Update to SW 04.00; misc.
editorial revisions.
2
A
A
CCU-C
HEK
CCU-
HEK
Operator’s Manual
®
Inform II System
Version 5.0
0 4807839001 (05) 2013-09 EN
© 2008-2013, Roche Diagnostics. All rights reserved.
The contents of this document, including all graphics, are the property of Roche Diagnostics. 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. Roche Diagnostics has made every
reasonable effort to ensure that all the information contained in this manual is correct at the time of printing.
However, Roche Diagnostics reserves the right to make any changes necessary without notice as part of
ongoing product development.
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.
The Wi-Fi CERTIFIED Logo is a certification mark of the Wi-Fi Alliance.
4
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 instructions
for use accompanying this product.
Temperature limitation (Store at)
Manufacturer
Catalog number
IVD
7.5V 1.7A
On meters with WLAN capability:
For other WLAN certifications, see label on bottom of battery compartment and list included in meter kit.
In vitro diagnostic medical device
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).
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).
Power supply connection
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.
5
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6
1 Introduction 13
1.1 Before you start......................................................................................................................................... 13
Intended use ...................................................................................................................................... 13
Important information regarding use ....................................................................................... 13
If you need help................................................................................................................................ 14
Note on the use of “base unit” in this manual...................................................................... 14
Note on illustrations in this manual .......................................................................................... 14
What can the system do for you? .............................................................................................. 15
1.2 Important safety instructions and additional information......................................................... 16
Important information regarding safety................................................................................... 17
Disposal of the system ................................................................................................................... 18
Product safety.................................................................................................................................... 19
General care....................................................................................................................................... 19
Accessory box ................................................................................................................................... 19
Meter .................................................................................................................................................... 19
Automatic power-off....................................................................................................................... 19
Battery Pack ....................................................................................................................................... 20
Touchscreen....................................................................................................................................... 21
Electrostatic discharge (ESD)...................................................................................................... 21
Local Area Network: protection from unauthorized access ............................................ 22
Wired network connection ........................................................................................................... 22
Wireless connectivity ...................................................................................................................... 23
Radiofrequency radiation exposure information.................................................................. 24
1.3 System components................................................................................................................................ 27
1.4 Overview of the meter ............................................................................................................................ 28
1.5 Overview of the code key reader ....................................................................................................... 30
1.6 Overview of the base unit ..................................................................................................................... 31
1.7 Overview of the Accu-Chek Inform II Base Unit Hub................................................................. 32
1.8 Overview of the accessory box ........................................................................................................... 33
1.9 Reagents and consumables................................................................................................................. 33
1.10 Instructions for initial setup.................................................................................................................. 34
2 Powering Up and Entering an Operator ID 35
2.1 Powering up the meter .......................................................................................................................... 35
Adjusting the display ...................................................................................................................... 36
Enabling/disabling wireless connectivity ................................................................................ 36
Closing startup.................................................................................................................................. 37
2.2 Entering the operator ID........................................................................................................................ 38
Entering an operator ID with barcode scanner .................................................................... 39
Entering the operator ID manually ............................................................................................ 40
Entering a password ....................................................................................................................... 40
7
3 Patient Glucose Testing 41
3.1 Information regarding blood glucose testing ................................................................................ 41
Preparing to test ............................................................................................................................... 41
3.2 Performing a patient glucose test...................................................................................................... 42
Overview of test procedure .......................................................................................................... 42
Entering or selecting the patient ID .......................................................................................... 43
Entering the patient ID manually................................................................................................ 45
Selecting the patient ID from a list............................................................................................ 45
Entering a patient ID with barcode scanner .......................................................................... 46
Confirming or selecting the test strip lot................................................................................. 47
Inserting test strips .......................................................................................................................... 48
Obtaining a blood sample............................................................................................................. 49
Applying a blood sample............................................................................................................... 50
Results screen ................................................................................................................................... 51
Adding comments............................................................................................................................ 54
4 Glucose Control Testing 57
4.1 Information regarding glucose control tests.................................................................................. 57
Glucose control testing intervals................................................................................................ 58
Information stored during glucose control testing.............................................................. 59
Control solutions............................................................................................................................... 60
Preparing to run a glucose control test ................................................................................... 60
4.2 Performing glucose control tests ....................................................................................................... 61
Overview of test procedure .......................................................................................................... 61
Starting a glucose control test .................................................................................................... 62
Confirming or selecting the lot number for control solutions ......................................... 63
Confirming or selecting the test strip lot................................................................................. 64
Inserting test strips .......................................................................................................................... 65
Applying the control solution....................................................................................................... 66
Results screen ................................................................................................................................... 67
Performing a STAT test .................................................................................................................. 68
5 Review Results 69
5.1 Displaying test results from the memory ........................................................................................ 69
Information stored in data records for test results.............................................................. 69
List of results stored in the memory.......................................................................................... 70
6 Storing Test Strip, Control Solution, and Linearity Solution
Information in the Meter 73
6.1 Storing information about test strips ................................................................................................ 73
Transferring code key information to the meter................................................................... 74
Editing test strip data...................................................................................................................... 77
6.2 Storing control solution information ................................................................................................. 80
Entering the lot number of the control solution ................................................................... 80
Selecting a stored lot number as the current lot number................................................. 83
6.3 Storing linearity test information ........................................................................................................ 85
Entering the lot number of the linearity test .......................................................................... 85
Selecting a stored lot number as the current lot number................................................. 87
8
7 Linearity Testing 89
7.1 Information regarding linearity tests................................................................................................. 89
Linearity testing intervals .............................................................................................................. 90
Information stored during linearity testing............................................................................. 90
Linearity test kit ................................................................................................................................ 91
Preparing to run a linearity test .................................................................................................. 91
7.2 Performing a linearity test..................................................................................................................... 92
Overview of test procedure .......................................................................................................... 92
Starting a linearity test ................................................................................................................... 92
Confirming or selecting the lot number for linearity test kits.......................................... 93
Confirming or selecting the test strip lot................................................................................. 93
Inserting test strips.......................................................................................................................... 94
Applying a linearity test sample ................................................................................................. 95
Results screen ................................................................................................................................... 96
8 Proficiency Testing 97
8.1 Information regarding proficiency tests .......................................................................................... 97
Information stored during proficiency testing....................................................................... 98
Preparing a proficiency test ......................................................................................................... 98
8.2 Performing a proficiency test............................................................................................................... 99
Overview of test procedure .......................................................................................................... 99
Starting a proficiency test............................................................................................................. 99
Entering the proficiency sample ID........................................................................................ 100
Confirming or selecting the test strip lot.............................................................................. 100
Inserting test strips....................................................................................................................... 101
Applying a proficiency sample................................................................................................. 102
Results screen ................................................................................................................................ 103
9 Initial Startup 105
9.1 Connecting the base unit ................................................................................................................. 105
9.2 Installing or replacing the battery pack ...................................................................................... 106
Removing the battery pack ....................................................................................................... 107
Installing the battery pack ......................................................................................................... 108
9.3 Docking the meter................................................................................................................................ 110
9.4 Initial setup on the meter................................................................................................................... 112
Menu overview............................................................................................................................... 113
9.5 Opening the Setup Menu .................................................................................................................. 116
9.6 Date and time format........................................................................................................................... 117
9.7 Display options and optional tests ................................................................................................. 118
9.8 Options for test strips .......................................................................................................................... 119
9.9 Options for glucose control tests.................................................................................................... 121
9.10 Value ranges (normal, critical, reportable).................................................................................. 123
9.11 Options for Operator ID Entry........................................................................................................... 124
9.12 Patient ID options.................................................................................................................................. 125
9.13 Creating a setup password................................................................................................................ 126
9.14 Setting the date and time................................................................................................................... 127
9.15 Beeper options....................................................................................................................................... 128
9
10 Maintenance and Care 129
10.1 Conditions for storage and shipping ............................................................................................. 129
General operating conditions ................................................................................................... 129
Storage .............................................................................................................................................. 130
10.2 Cleaning/disinfecting the Accu-Chek Inform II system.......................................................... 130
Acceptable cleaning/disinfecting agents............................................................................. 131
Cleaning/disinfecting the meter .............................................................................................. 132
How to clean/disinfect ................................................................................................................ 134
Cleaning the barcode scanner window................................................................................ 136
Cleaning/disinfecting the base unit ....................................................................................... 136
Cleaning/disinfecting the accessory box ............................................................................. 137
Cleaning the code key reader .................................................................................................. 138
Cleaning the Accu-Chek Inform II Base Unit Hub............................................................ 138
10.3 Logging maintenance activities....................................................................................................... 139
10.4 Diagnostics view.................................................................................................................................... 140
10.5 Unlocking a Download Lockout ...................................................................................................... 142
10.6 Deleting patient data ........................................................................................................................... 144
11 Troubleshooting 145
Errors and unusual behavior without error messages .................................................... 145
Pop-up messages.......................................................................................................................... 149
Meter reset ...................................................................................................................................... 151
12 General Product Information 153
12.1 Technical data ....................................................................................................................................... 153
12.2 Further Information............................................................................................................................... 156
Ordering ........................................................................................................................................... 156
Accu-Chek Inform II Operator’s Manual and Quick Reference Guide..................... 157
Reagents and Solutions.............................................................................................................. 157
Information about software licenses...................................................................................... 158
Contact Roche................................................................................................................................ 159
A Appendix 161
A.1 Table of configuration options ......................................................................................................... 161
A.2 Example of barcode symbologies ................................................................................................... 173
B Appendix 175
B.1 Option: Wireless network (WLAN).................................................................................................. 175
Preliminary note............................................................................................................................. 175
Background ..................................................................................................................................... 175
Technical implementation.......................................................................................................... 176
RF specific functionalities and effective performance claims...................................... 178
10
C Supplement for Other Test Entry 181
C.1 Before you start...................................................................................................................................... 181
Description ...................................................................................................................................... 181
C.2 Overview of Other Test Entry (OTE) ............................................................................................... 182
Introduction..................................................................................................................................... 182
C.3 Recording Other Patient Tests ......................................................................................................... 185
C.4 Recording Other Control Tests ........................................................................................................ 192
Introduction..................................................................................................................................... 192
Other Control Testing Intervals................................................................................................ 192
Stored Control Information........................................................................................................ 192
Warning messages ....................................................................................................................... 198
C.5 Reviewing Other Test Results........................................................................................................... 199
C.6 Other Test Entry Configuration Options ....................................................................................... 202
D Supplement for Observed Test Sequence 203
Observed Test Sequence (OTS)............................................................................................... 203
Using the OTS function............................................................................................................... 204
Index 207
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12
Introduction • 1
1 Introduction
1.1 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 “Important safety instructions and
additional information” section in this chapter before
operating the system.
13
1 • 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
14
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.
Introduction • 1
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 appli-
cation, 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
■ Record patient test results, quality control test
results and reagent information for certain offmeter manual tests.
■ 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
15
1 • Introduction
1.2 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 the Accu-Chek Inform II manual. Please
read these passages 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
CAUTION
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.
16
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.
Important information regarding safety
WARNING
Introduction • 1
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.
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.
■ Use gloves. Wear a new pair of clean gloves for
testing each patient.
■ Wash hands thoroughly with soap and water
before putting on a new pair of gloves and performing the next patient test.
■ Use an auto-disabling single-use lancing device
for each patient.
■ Dispose of used lancets in a sturdy sharps con-
tainer 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.
17
1 • Introduction
CAUTION
Disposal of the system
WARNING
Allergy or injury caused by reagents and other
working solutions
Direct contact with reagents, detergents, cleaning/disinfection solutions, or other working solutions may cause
skin irritation or inflammation.
■ Always use protective gloves.
■ Observe the cautions given in the package inserts of
the reagents and cleaning/disinfection solutions.
■ If a reagent, control, linearity, or cleaning/disinfection
solution comes into contact with your skin, wash it off
immediately with water.
■ Follow all health and safety regulations in force
locally.
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.
18
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.
Introduction • 1
Product safety Observe the following information to ensure product
safety:
■ The system is suitable for continuous operation.
NOTICE
General care
NOTICE
Accessory box
NOTICE
Meter
Automatic power-off
The system is not protected against the harmful ingress
of fluids (IP X0 rating according to IEC 60529).
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
and disinfecting.
Carry the accessory box carefully by the handle for easy
transport. Dropping or hitting the box may damage it.
■ Dispose of the meter in accordance with applicable
laws and regulations. See “Disposal of the system”
on page 18.
■ Unless otherwise configured, the system automati-
cally powers off after 5 minutes of inactivity (e.g., no
screen touches, strip insertions).
■ 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 inactivity.
19
1 • 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:
Disposal of used batteries
Do not dispose of the batteries with normal domestic
waste. Dispose of used batteries in accordance with
applicable local regulations and directives and your
facility’s guidelines on the disposal of electronic waste
equipment.
■ 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 power 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.
20
■ The Battery Critically Low warning indicates that
the meter must be returned immediately to the
base unit for recharging.
Touchscreen
Introduction • 1
NOTICE
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.
Electrostatic discharge (ESD) 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 requirements
according to EN 61326-1 and EN 61326-2-6. The system’s
emissions of the energy used are low and not likely to
cause interference in nearby electronically driven
equipment.
21
1 • Introduction
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.
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 If connected to a local area network, the Accu-Chek
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 measures, 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.
Inform II Base Unit or Accu-Chek Inform II Base Unit Hub
must be protected against unauthorized access by means
of a strong password management. Observe your own
facility guidelines on password management where available, or apply the following rules:
22
Introduction • 1
Characteristics of strong passwords
■ Passwords must not contain the user’s account
name or parts of the user’s full name that exceed
two consecutive characters.
■ Passwords must be at least eight characters in
length.
■ Passwords must contain characters from at least
three of the following four categories:
– English uppercase alphabetic characters
(A through Z)
– English lowercase alphabetic characters
(a through z)
– Numeric characters (0 through 9)
– Non-alphabetic characters (for example, !, $, #, %)
Examples of weak passwords
■ uhxwze11 contains no upper case letter.
■ UHXW13SF contains no lower case letter.
■ uxxxxx7F contains the same character more than
four times.
■ x12useridF contains a substring of the user ID
longer than four characters.
Wireless connectivity If the meter is equipped with WLAN functionality:
Wireless connectivity 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 36. 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.
23
1 • Introduction
Radiofrequency radiation exposure information
Glossary:
■ “FCC” stands for “Federal Communications
Commission” (USA).
■ “RF” stands for “radio frequency”
■ “RSS” stands for “Radio Standards Specification”
(Canada).
■ “WLAN” stands for “Wireless Local Area
Network”
The Industrial, Scientific and Medical (ISM) radio
frequencies may contain emissions from microwave
ovens, heaters, and other noncommunication devices.
While these types of devices usually pose no threat of
interference as they are low-powered devices, the possibility exists that some industrial high power systems may
wipe out any attempted communication use of a WLAN.
Therefore, perform a site survey and interference analysis
with a spectrum analyzer to view the entire spectrum,
looking for signals that might not only be within the frequency range of the intended WLAN but also could be
near or at the same frequency and cause interference.
24
Introduction • 1
Roche supports industry wireless standards and recommends using products that have Wi-Fi certification. This
certification tests products to the 802.11 industry standards for basic connectivity, security, authentication, Quality of Service (QoS), interoperability and reliability. The
Wi-Fi CERTIFIED logo is an assurance that the Wi-Fi Alliance has tested a product in numerous configurations
and with a diverse sampling of other devices to ensure
compatibility with other Wi-Fi CERTIFIED equipment that
operates in the same frequency band. The Wi-Fi Alliance
network of independent test labs conducts interoperability testing programs to ensure that wireless devices work
together and support secure connections.
The Accu-Chek Inform II system 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.
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.
25
1 • Introduction
The Accu-Chek Inform II system complies with the
emission and immunity requirements described in
EN 61326-2-6. 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 powering 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.
26
■ 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.
1.3 System components
A
B
C
D
Introduction • 1
The Accu-Chek Inform II system includes the following
components and accessories:
A Meter
B Code key reader
C Base unit (power supply not shown)
D Accu-Chek Inform II Base Unit Hub (power supply
not shown)
E Accessory box (shown with consumables, not
included)
The meter can be configured by two different methods:
1 Configuration via the Setup function on the meter
(see Chapter 9)
2 Configuration via data management system
Note: Not all options can be configured using the Setup
function on the meter.
The meter performs the following tasks within the system:
■ Serves as the primary operator interface through
the touchscreen and on/off button
■ Performs glucose tests
■ Scans barcodes
1
(test strip lots, controls, patient
and operator IDs) in a variety of supported formats
■ Displays test results from patient tests and control
tests
■ Transfers stored data to the data management
system via wireless communication (WLAN,
optional) or the base unit (LAN)
E
1. Barcodes on control solutions may not be available in all
countries. A list of supported barcode symbologies can be
found in Appendix A.2.
27
1 • Introduction
1.4 Overview of the meter
1
2
3
4
The meter has the following elements:
1 Test strip port
Insert the test strip here.
2 Touchscreen
(touch-sensitive display)
This screen allows you to perform patient tests, perform controls tests, and review results. To select
any of these functions, simply touch the button on
the screen.
3 On/Off button
Press this button to power the meter on or off.
4 Barcode scanner
The integrated barcode scanner can be used to
read operator and patient IDs.
5 Battery compartment cover
Remove to insert the battery pack.
6 Charging contacts
These contacts are used to charge the battery pack
when the meter is in the base unit.
28
7 Infrared window
5
6
7
Facilitates data communication with code key
reader and base unit.
8
9
10
11
Introduction • 1
8 Battery pack
Powers the device.
9 Wireless LAN label
If the meter supports wireless connectivity: This
label displays registration numbers that are specific
to the meter RF hardware.
10 Interface
(For manufacturer’s use only.)
11 Battery pack connector socket
Connect battery pack here.
8
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1 • Introduction
1.5 Overview of the code key reader
Test strip vials include a code key.1 This code key is read
by the code key reader and the data is sent to the meter.
14
For additional information about the code key reader, see
Chapter 6.
13
12
The code key reader has the following elements:
12 Code key slot
13 LED (green) for displaying status
14 Infrared window for transmitting the code file to the
meter
Do not replace code keys while the code key reader is
still flashing. If the green LED status light is still flashing, the code key reader will continue to transmit the
previously loaded code file and ignore the code file on
the newly inserted code key. You may get an error
message on the meter.
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1. The code key is also frequently referred to as a code chip.
The terms are synonymous.
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