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, COAGUCHEK and SAFE-T-PRO 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 and on the identification plate of the instrument 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)
Use by
Manufacturer
LOT
IVD
On meters with WLAN capability:
For other WLAN certifications, see label on bottom of battery compartment and addendum for
information on WLAN registration.
Batch code/ Lot number
Catalog number
In vitro diagnostic medical device
This product fulfills the requirements of the European Directive 98/79/EC on in vitro
diagnostic medical devices.
Consult instructions for use
The system fulfills the Canadian and U.S. safety requirements (UL LISTED, in
accordance with UL 61010A-1:02 and CAN/CSA-C22.2 No. 61010-1-04).
This device complies with Part 15 of the FCC Rules and with RSS-210 of Industry
Canada
5
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6
1Introduction 11
1.1 Before you start......................................................................................................................................... 11
Intended use ...................................................................................................................................... 11
Important information regarding use ....................................................................................... 11
If you need help................................................................................................................................ 12
General note....................................................................................................................................... 12
What can the system do for you? .............................................................................................. 12
Test principle ..................................................................................................................................... 13
Contents of the pack ...................................................................................................................... 14
1.2 Important safety instructions and additional information......................................................... 15
Quality control ................................................................................................................................... 27
1.3 Overview of the meter elements ....................................................................................................... 28
1.4 Buttons and icons overview ................................................................................................................. 30
1.5 Power supply.............................................................................................................................................. 33
2Putting the Meter into Operation 35
2.1 Installing or replacing the battery pack........................................................................................... 36
Removing the battery pack .......................................................................................................... 37
Installing the battery pack ............................................................................................................ 38
2.2 Powering the meter on and off........................................................................................................... 41
Checking the software version ................................................................................................... 41
3Meter Setup 43
Note on presentation of screen elements in this manual................................................. 43
Result Units ........................................................................................................................................ 50
Result Confirmation......................................................................................................................... 51
Language Selection......................................................................................................................... 52
Setting the date................................................................................................................................. 53
Setting the time................................................................................................................................. 55
Setting the display options for date and time ....................................................................... 56
Auto Off................................................................................................................................................ 62
QR Code............................................................................................................................................... 64
3.4 ID Setup ....................................................................................................................................................... 70
System Administrator (Admin.)................................................................................................... 72
Operator ID ........................................................................................................................................ 76
Patient ID ............................................................................................................................................ 77
QC Range ............................................................................................................................................ 80
4.1 Important notes......................................................................................................................................... 93
Getting a good capillary blood sample .................................................................................... 95
Getting a good result from venous whole blood.................................................................. 96
4.2 Preparing to test ....................................................................................................................................... 97
Test strip code chip ......................................................................................................................... 97
Inserting the code chip .................................................................................................................. 98
Powering on the meter................................................................................................................... 99
4.3 Performing a test .................................................................................................................................. 102
Applying blood from the fingertip........................................................................................... 108
Applying blood with a syringe.................................................................................................. 109
Accepting or rejecting a test result........................................................................................ 112
Displaying the test result as QR code ................................................................................... 114
Finishing the test ........................................................................................................................... 114
STAT tests ........................................................................................................................................ 115
5Control and Proficiency Testing 117
5.1 Control testing........................................................................................................................................ 117
5.2 Preparing to perform a liquid quality control test..................................................................... 118
5.3 Performing a liquid quality control test......................................................................................... 120
5.5 Preparing to perform a proficiency test........................................................................................ 128
5.6 Performing a proficiency test............................................................................................................ 129
6Review Results (Memory) 133
6.1 Viewing test results .............................................................................................................................. 134
Display patient result memory ................................................................................................. 136
Display QC (quality control) result memory........................................................................ 137
7Extended Functionalities 139
7.1 Data handling......................................................................................................................................... 139
8.4 Cleaning/disinfecting the exterior (meter housing)................................................................. 152
8.5 Cleaning/disinfecting the test strip guide ................................................................................... 153
8.6 Cleaning the scanner window.......................................................................................................... 154
9Troubleshooting 155
Additional information on error E-406 .................................................................................. 156
Errors and unusual behavior without error messages .................................................... 157
Meter reset ...................................................................................................................................... 158
10General Product Specifications 159
10.1 Technical data ....................................................................................................................................... 159
Sample material ............................................................................................................................ 159
Transport conditions .................................................................................................................... 160
10.2 Further Information .............................................................................................................................. 161
RF specific functionalities and effective performance claims...................................... 179
Index 183
1Introduction
1.1Before you start
Intended use The CoaguChek® Pro II system (consisting of the
CoaguChek Pro II meter and the CoaguChek family of test
strips) is used for the determination of PT and aPTT by
healthcare professionals in a Point of Care environment.
11
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 time.
You must configure the CoaguChek Pro II meter according to your needs before initial use. Refer to chapter 3,
Meter Setup. Be sure to read the “Important safety
instructions and additional information” section in this
chapter before operating the system.
Before you use the meter for the first time (after you
have first inserted the battery pack), you must set the
date and time correctly to allow you to perform measurements properly. Each time you replace the battery
pack you need to check (and, if necessary adjust) the
date and time.
QC Lockout is disabled by default. For routine confirmation of system reliability it is recommended to enable
this feature.
Introduction • 1
12
If you need help Information about using the system, the screen menus,
and performing a test can be found in this manual.
When error messages appear on the screen, refer to
chapter 9, Troubleshooting.
For all questions about the CoaguChek Pro II system that
are not answered in this manual, contact your Roche
Diagnostics representative. In order to expedite troubleshooting, please have ready your CoaguChek Pro II
meter, its serial number, this manual, and all related consumables when you call.
General noteThe data and information provided in this manual are
current as of issue. Any substantial changes will be incorporated in the next edition. If there is any conflict of information, the package insert included with the CoaguChek
test strips shall prevail.
What can the system do for you?The CoaguChek Pro II system makes coagulation testing
easy. You only need to insert the code chip, power the
meter on, insert the test strip, and apply a small blood
sample. The blood mixes with the reagents on the test
strip, and the meter determines when the blood clots.
Depending on which test parameter is selected, the
meter displays the results after approximately one minute
(PT) or after several minutes (aPTT). After the
measurement, the meter automatically stores the test
result, together with date/time and patient ID (and
operator ID, if that option is enabled) to memory.
The CoaguChek Pro II meter displays test results in units
equivalent to laboratory plasma measurements. Results
may be displayed in the following ways:
■Parameter: aPTT
– seconds
■Parameter: PT
– International Normalized Ratio (INR)
– combination of INR/seconds, or
– combination of INR/%Quick
INR is a standardized measurement of the rate at which
blood clots. A low INR can indicate an increased risk of
blood clots, while an elevated INR can indicate increased
risk of bleeding.
The meter guides you through the test, step by step,
using icons and instructions on the display. Each box of
test strips has its own code chip that you insert into the
meter. This code chip contains lot-specific information
about its test strips, such as the expiration date and calibration data. Optional liquid controls for the system are
also available.
The CoaguChek Pro II meter has the ability to connect to
a data management system (DMS) through the Handheld
Base Unit from Roche Diagnostics (available separately)
or via wireless communication (WLAN). The CoaguChek
Pro II meter supports data exchange via the POCT1A
standard. Data management systems may have the ability
to expand the security features of the meter, such as enabling operator lockouts. Data management systems may
also enable data transfer from a HIS and/or to a LIS. Refer
to the manuals of the Handheld Base Unit and of your
DMS for technical details.
13
Test principleThe CoaguChek Tests contain desiccated reagents.
These consist of activators, a peptide substrate, and nonreactive components. When a sample is applied to a test
strip, the reagent dissolves and the activators start the
coagulation process, leading to the formation of the
enzyme thrombin. Simultaneously the meter starts to
measure the time. Thrombin cleaves the peptide substrate, generating an electrochemical signal. Depending
on the time elapsed when this signal first appears, it is
converted via an algorithm into customary coagulation
units (depending on the test, into INR, %Quick, or
seconds) and the result is displayed.
Introduction • 1
14
Contents of the packThe CoaguChek Pro II pack contains the following items:
■CoaguChek Pro II meter
■Universal Battery Pack
■Power supply
■Operator’s Manual (printed version, not shown
here)
■Manual CD ROM (contains PDF files of the Opera-
tor’s Manual in other languages, not shown here)
Check for completeness and transport damage immediately after unpacking.
1.2Important 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 CoaguChek Pro II Operator’s
Manual. 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.
These symbols and signal words are used for specific
hazards:
WARNING
Indicates a hazardous situation which, if not avoided,
WARNING
CAUTION
could result in death or serious injury.
CAUTION
Indicates a hazardous situation which, if not avoided,
could result in minor or moderate injury.
15
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.
Introduction • 1
16
Illustrations in this manual show two different kinds of
hands:
Hand without gloveHand with glove
A dashed arrow between screen illustrations indicates
that some screens have been skipped in these
illustrations.
Safety information
WARNING
17
Operator qualification
Only trained healthcare professionals may operate the
CoaguChek Pro II system. Operators must have received
comprehensive instruction in the operation, quality control, and care of the CoaguChek Pro II system.
Protection against infection
There is a potential risk of infection. Healthcare professionals using the CoaguChek Pro II system must be
aware that any object coming into contact with human
blood is a potential source of infection. Healthcare
professionals must also be aware that any cross-contamination is a potential source of infection for patients.
■ Use gloves.
■ Use an auto-disabling single-use lancing device for
each patient.
■ Dispose of used lancets and needles in a sturdy
sharps container with lid.
■ Dispose of used test strips according to your institu-
tion’s infection control policy.
■ Follow all health and safety regulations in force
locally.
WARNING
Avoidance of electrical shock, fire, and explosions
■ Only use Roche Diagnostics original accessories
(cables, power supply units, battery packs, and spare
parts). Third-party cables, power supply units, and
battery packs can cause the battery pack to explode
or the meter to become damaged.
■ Do not use loose power sockets or damaged power
supply units, cables, plugs, or battery packs.
■ Do not short circuit the power supply unit, the
Handheld Base Unit contacts, or the battery pack.
■ Do not drop the CoaguChek Pro II meter, the power
supply unit, or the battery pack and protect these
against shaking and vibrations.
Introduction • 1
18
Disposal of the system
General care
WARNING
Infection by a potentially biohazardous instrument
The CoaguChek Pro 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. Always remove the
battery pack before thermal disinfection.
NOTICE
Clean the meter only with the solutions recommended
(see page 147). Using other solutions may result in
incorrect operation and possible system failure. Do not
let cleaning solution enter the instrument. Make sure
that the meter is thoroughly dried after cleaning or
disinfecting.
Battery packThe meter contains a rechargeable battery pack that
begins charging as soon as the power adapter is connected or the meter is placed on an active Handheld 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.
WARNING
19
Possible hazards posed by the battery pack
Damaged or swollen battery packs can overheat, catch
fire, or leak. Immediately cease use of CoaguChek Pro II
meters with damaged or swollen battery packs and
under no circumstances recharge them (do not place in
the Handheld Base Unit).
Overheating can cause the battery pack to catch fire or
explode.
■Never throw the battery pack or the meters onto a
fire. Do not dismantle, compress, or pierce the
battery pack as this could cause an internal short
circuit that leads to overheating.
■Do not place either the battery pack or the
CoaguChek Pro II meter on or in heating appliances, such as a microwave, conventional oven, or
radiator.
■Avoid prolonged exposure to direct sunlight, e.g.,
when the meter is docked in the Handheld Base
Unit. Keep this in mind when positioning the Handheld Base Unit.
Battery fluid or materials leaking from damaged battery
packs can irritate your skin or cause burns due to high
temperatures.
■Avoid contact with leaking battery fluid. In the
event of accidental contact with the skin, rinse with
water. If you get battery fluid in your eye(s), you
should also seek medical attention.
Handle and dispose of battery packs with care.
Extreme temperatures reduce the charging capacity
and usage period of the meter and the battery pack.
Introduction • 1
20
Observe the following general safety instructions for
handling the battery pack:
Disposal of used battery packs
Do not dispose of the battery pack with normal domestic
waste. Dispose of used battery packs 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 7).
■Always power the meter off before removing the
battery pack.
■When the Battery Low warning is displayed, the
meter must be returned as soon as possible to
the Handheld Base Unit or connected to the power
adapter for recharging.
■When the battery capacity is too low for further
tests, the meter must be returned immediately to
the Handheld Base Unit or connected to the power
adapter for recharging.
Electromagnetic InterferenceThe meter fulfills the IEC 61326-2-6 requirements for
emitted interference and interference immunity.
Do not use the meter near strong electromagnetic fields,
which could interfere with the proper operation of the
meter.
Electrostatic discharges may cause malfunction of the
meter.
Touchscreen
21
NOTICE
Local Area Network: protection
from unauthorized access
Use only your finger (even when wearing gloves) or
■
special pens designed for use with touchscreens to
touch the screen elements. Using pointed or sharpedged objects can damage the touchscreen.
■ Avoid prolonged exposure to direct sunlight. Direct
sunlight may reduce the life expectancy and functionality of the display.
■If this meter 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.
■If you use a customized data management system
solution, ensure that sensitive data transmitted via
the POCT1-A interface is protected by appropriate
security measures.
■Ensure that the instrument is protected against
unauthorized physical access and theft.
■Do not use shared user or operator accounts on
meter, DMS and network.
■Whether working in a wired or wireless environ-
ment, use a strong password for user or operator
accounts on the meter, DMS, and network. Observe
your own facility guidelines on password management where available, or apply the rules for strong
passwords, see “Characteristics of strong passwords” below.
Introduction • 1
22
Wired network connectionIf the Handheld Base Unit from Roche Diagnostics is
used to connect this meter to a local area network, the
Handheld Base Unit must be protected against unauthorized access by means of a strong password manage-ment. Observe your own facility guidelines on password
management where available, or apply the following
rules:
Characteristics of strong passwords
■Passwords should not contain the user’s account
name or parts of the user’s full name that exceed
two consecutive characters.
■Passwords should be at least eight characters in
length.
■Passwords should contain characters from the
following three categories:
– English uppercase alphabetic characters
(A through Z)
– English lowercase alphabetic characters
(a through z)
– Numeric characters (0 through 9)
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 connectivityIf 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 Handheld 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 a description of the CoaguChek Pro II meter’s
ability to connect to Wireless Local Area Networks
(WLAN, Wi-Fi), see appendix C.1.
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”
23
Introduction • 1
24
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.
Roche Diagnostics 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 CoaguChek Pro 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
Introduction • 1
26
The CoaguChek Pro 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.
■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.
Operating conditionsTo ensure that the meter functions properly, please
observe the following guidelines:
■Only use the meter at a room temperature between
12 °C and 32 °C (54 °F and 90 °F).
■Only use the meter at a relative humidity between
10% and 85% (no condensation).
■When operating the meter using the power adapter,
use only a voltage of 100 V to 240 V (± 10%) , 50/
60 Hz.
■When testing, place the meter on a level, vibration-
free surface, or hold it so it is roughly horizontal.
Quality controlThe meter has a number of built-in quality-control
functions:
■A check of the electronic components and func-
tions every time the meter is powered on.
■A check of the test strip temperature while a test is
in progress.
■A check of the expiration date and lot information
on the test strip based on the code chip data.
■An onboard quality control within every single test
strip.
Roche Diagnostics offers liquid quality controls for the
CoaguChek Pro II system. These controls are designed to
assist you in meeting regulatory compliance requirements at your facility.
27
Introduction • 1
28
1.3Overview of the meter elements
B
C
D
A
E
F
HIGJ
E
29
ATouchscreen
Shows test results, information, icons,
and results recalled from memory. To
select an option, simply touch the
button lightly.
BOn/Off button
Press this button to power the meter on
or off.
CTest strip guide cover
Remove this cover to clean the test strip
guide (if it has become soiled, e.g., with
blood).
DTest strip guide
Insert the test strip here.
EBarcode scanner
The integrated barcode scanner can
scan operator, patient, and QC sample
IDs into the meter.
FBattery compartment cover
Remove to insert the battery pack.
GCharging terminals
Used for power supply and/or charging
the battery pack when the meter is
docked in the (optional) Handheld Base
Unit.
HCode chip slot (shown with code chip)
Insert the code chip here.
IConnection socket for power
adapter
Plug in the power adapter here.
JInfrared interface
(Covered by the semi-transparent
panel) Supports data communication.
Introduction • 1
30
1.4Buttons and icons overview
Button/IconMeaning
Go to Main Menu
OK; save setting
Cancel; discard setting
Return (to previous menu)
Decrease/increase the value displayed.
Scroll through lists that are too long to be displayed all at once.
Inactive button:
Value cannot be further decreased/increased or:
End of list in this direction is reached
List of tests of a specific patient
The buttons and icons that appear during normal operation are shown here, along with their respective meanings. Error messages and the description of the icons
linked to them are provided in a separate chapter. See
“Troubleshooting” starting on page 155.
Print after test result or from memory
Display test result as QR code
Add a comment
Operator must wait until the meter has completed an action
Insert test strip
Remove test strip
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