Accu-Chek Inform II User manual

ACCU-CHEK®Inform II
BLOOD GLUCOSE MONITORING SYSTEM
Operator’s Manual

2
Manual version Revision date Changes
Version 1.0 2012-10 New document
Version 2.0 2013-02 Upgrade to FW 03.04; Revise
critically ill statement
Version 3.0 2013-03 Update cleaning and disinfecting
chapter

©2013 Roche Diagnostics. All rights reserved. 05234646002 2013-03 USA
ACCU-CHEK
®
Inform II System
Operator’s Manual

4
©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 certication mark of the Wi-Fi Alliance.
On the packaging, on the identication 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
IVD
In vitro diagnostic medical device
This product fullls 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 fullls 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 1.7A
Power supply connection

5
1 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
2 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

6
3 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
Conrming or selecting the test strip lot ...................................................................................44
Inserting test strips............................................................................................................................45
Applying a blood sample.................................................................................................................46
Results screen.....................................................................................................................................47
Adding comments.............................................................................................................................50
4 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
Conrming or selecting the lot number for control solutions ............................................56
Conrming or selecting the test strip lot ...................................................................................57
Inserting test strips............................................................................................................................58
Applying the control solution ........................................................................................................59
Results screen.....................................................................................................................................60
Performing a STAT test.....................................................................................................................60
5 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

7
6 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
7 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
Conrming or selecting the lot number for linearity test kits .............................................84
Conrming or selecting the test strip lot ...................................................................................84
Inserting test strips............................................................................................................................85
Applying a linearity test sample....................................................................................................86
Results screen.....................................................................................................................................87
8 ProciencyTesting 89
Information regarding prociency tests ............................................................................................89
Information stored during prociency testing.........................................................................90
Preparing a prociency test ...........................................................................................................90
Performing a prociency test.................................................................................................................91
Overview of test procedure ............................................................................................................91
Starting a prociency test...............................................................................................................91
Entering the prociency sampleID .............................................................................................92
Conrming or selecting the test strip lot ...................................................................................92
Inserting test strips............................................................................................................................93
Applying a prociency sample......................................................................................................94
Results screen.....................................................................................................................................95

8
9 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
10 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

9
11 Troubleshooting 133
Errors and unusual behavior without error messages........................................................133
Error messages.................................................................................................................................137
Meter reset.........................................................................................................................................139
12 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 conguration 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 specic functionalities and effective performance specications...........................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 Conguration 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 187

10
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Introduction
11
1 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 ngertips 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

Introduction
12
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 rst test.
You must congure the ACCU-CHEK Inform II system
according to your needs before initial use. You can
con gure 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
conguration. Refer to Appendix A for conguration 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

Introduction
13
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 specied, 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.

Introduction
14
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

Introduction
15
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 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
Indicates a hazardous situation which, if not avoided,
could result in death or serious injury.
CAUTION
CAUTION
Indicates a hazardous situation which, if not avoided,
could result in minor or moderate injury.
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 nd additional information
on correct use of the meter or useful tips.

Introduction
16
Important information regarding
safety
Operator qualication
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 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
prociency 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
17
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 uids (IPX0 rating according to IEC60529).
General care
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.
Accessory box
NOTICE Carry the accessory box carefully by the handle for easy
transport. Dropping or hitting the box may damage it.
Meter
n Unless otherwise congured, 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, prociency or linearity), the
meter will power off after 10 minutes of inactivity
(no screen touches), independently of congured
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.

Introduction
18
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).
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
19
Touchscreen
NOTICE n Use only your nger 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.
Laser scanner
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
A barcode does not need to be present for the laser
scanner to become active. Do not stare directly into the
laser beam.
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 specied 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.

Introduction
20
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
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 rewall, to
separate the device from uncontrolled networks as well
as measures that ensure that the connected network is
free of malicious code.
Wired network connection
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.
Wireless network connection
(RF card)
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 congured 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.