Roche CoaguChek Pro II User manual

CoaguChek® ProII
Operator’s Manual

0 8251398001 (03) 2020-10 EN-CAN
CoaguChek® ProII
Operator’s Manual
Publication version 3.0
Software version 04.05

3
CoaguChek® ProII · Operator’s Manual
Publication information
Manual
version
Revision date Changes
1.0 2017-09 New document, based on international CoaguChek
ProII manual 07154879001(04)EN2017-04.
2.0 2018-09 Software update, valid for SW04.03.xx; new features:
lockout configuration extension; QC interval reset;
miscellaneous editorial revisions.Based on international
CoaguChek ProII manual
07154879001(05)EN2018-09.
3.0 2020-10 Software update, valid for SW04.04.xx. All changes
included from addendum, Version 1, 2019-09,
09073434001(01)2019-09EN.
Software update, valid for SW04.05.xx.
License information 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.
Feedback Please send questions or comments about this manual
to your local Roche representative.
Copyright © 2015-2020 Roche Diagnostics GmbH. All rights
reserved.

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CoaguChek® ProII · Operator’s Manual
Trademarks ACCU‑CHEK, COAGUCHEK and SAFE‑T‑PRO are
trademarks of Roche.
All other trademarks are the property of their
respective owners.
Approvals
The Wi‑Fi CERTIFIED Logo is a certification mark of
the Wi‑Fi Alliance.

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CoaguChek® ProII · Operator’s Manual
Symbols and abbreviations
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)
Admissible humidity (Store at)
Use by
Manufacturer
Date of manufacture
LOT
Batch code/ Lot number
Catalog number
Global Trade Item Number
SN
Serial Number
IVD
In vitro diagnostic medical device
This product fulfills the requirements of the European
Directives98/79/EC on in vitro diagnostic medical devices and
2014/53/EU on the harmonisation of the laws of the Member States
relating to the making available on the market of radio equipment.
Consult instructions for use

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CoaguChek® ProII · Operator’s Manual
The system fulfils 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).
12V 1.25A
Power supply connection
On meters with WLAN capability:
This device complies with Part 15 of the FCC Rules and with
RSS‑210 of Industry Canada
For other WLAN certifications, see label on bottom of battery
compartment and addendum for information on WLAN registration.

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CoaguChek® ProII · Operator’s Manual
Table of contents
Publication information.......................................................................... 3
Symbols and abbreviations..................................................................... 5
What is new in publication version 3.0?..................................................... 9
1 Introduction 11
1.1 Before you start............................................................................... 11
1.2 Important safety instructions and additional information .......................... 16
1.3 Overview of the meter elements.......................................................... 29
1.4 Buttons and icons overview................................................................ 31
1.5 Power supply .................................................................................. 35
2 Putting the Meter into Operation 37
2.1 Installing or replacing the battery pack................................................. 38
2.2 Powering the meter on and off............................................................ 43
3 Meter Setup 45
3.1 Display of screen elements ................................................................ 45
3.2 Settings summary ............................................................................ 47
3.3 Screen setup................................................................................... 52
3.4 Options setup.................................................................................. 62
3.5 ID setup......................................................................................... 76
3.6 QC Settings setup............................................................................ 85
3.7 Diagnostics..................................................................................... 99
4 Testing a Blood Sample 101
4.1 Important notes............................................................................... 101
4.2 Preparing to test.............................................................................. 105
4.3 Performing a test ............................................................................. 110
5 Control and Proficiency Testing 123
5.1 Control testing................................................................................. 123
5.2 Preparing to perform a liquid quality control test .................................... 124
5.3 Performing a liquid quality control test ................................................. 127
5.4 Proficiency testing............................................................................ 134
5.5 Preparing to perform a proficiency test................................................. 135
5.6 Performing a proficiency test.............................................................. 136
6 Review Results (Memory) 141
6.1 Viewing test results.......................................................................... 142
7 Extended Functionalities 147
7.1 Data handling ................................................................................. 147

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CoaguChek® ProII · Operator’s Manual
8 Maintenance and Care 153
8.1 Conditions for storage and shipping .................................................... 153
8.2 Cleaning and disinfecting the meter..................................................... 155
8.3 Cleaning/disinfecting the exterior (meter housing).................................. 158
8.4 Cleaning/disinfecting the test strip guide .............................................. 161
8.5 Maintenance cleaning of the interior test strip guide in case of residue
build‑up.............................................................................................. 165
8.6 Cleaning the scanner window............................................................. 167
9 Troubleshooting 169
9.1 Status / Error messages..................................................................... 169
9.2 Shut down / restart / reset meter......................................................... 176
10 General Product Specifications 179
10.1 Technical data............................................................................... 179
10.2 Further information......................................................................... 181
11 Warranty 183
12 Appendix A 185
A.1 Operator and patient ID barcode masks ............................................... 185
A.2 Example of barcode symbologies........................................................ 186
A.3 Supported characters in 2D barcodes.................................................. 189
13 Appendix B 191
B.1 Supplement for Observed Test Sequence ............................................. 191
Using the OTS function.......................................................................... 192
14 Appendix C 195
C.1 Option: Wireless network (WLAN)....................................................... 195
Index 200

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CoaguChek® ProII · Operator’s Manual
What is new in publication version 3.0?
This section provides an overview of all major changes
from Operator’s Manual version2.0 to version3.0.
Deletions or minor corrections are not listed.
SW04.04.xx ¾Icons added: Battery-, infrared-, and
WLAN status
u1.4 Buttons and icons overview (31)
¾Change in Test result screen showing
the "C"
uTo accept/reject a test result (117)
¾Change in Observed Test Sequence
screen
uTo log on as an operator during OTS
(193)
SW04.05.xx ¾Icons added: Server certificate status
and Reset
u1.4 Buttons and icons overview (31)
¾Improved data retention options
uTo configure the database (72)
¾TLS encrypted WLAN communication
uTo connect to the computer (69)
uTo connect to the printer (71)
¾New Error History option and
Certificates screen
u3.7 Diagnostics (99)
uError History (173)
¾New format of Error message screens
u9.1 Status / Error messages (169)
Editorial revisions ¾Changes in Settings summary to
accommodate SW04.05.xx changes
u3.2 Settings summary (47)
What is new in publication version 3.0?

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CoaguChek® ProII · Operator’s Manual
¾More detailed description of Database
option
uTo configure the database (72)
¾More detailed description of TLS
configuration
uTo connect to the computer (69)
uTo connect to the printer (71)

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CoaguChek® ProII · Operator’s Manual
1 Introduction
1.1 Before 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.
Important information
regarding use Released and launched parameters are
country‑specific. Only parameters available on the
market in the respective country can be activated.
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.
uTo set the time (59)
uTo set the date (58)
uTo set the date and time format (60)
uQC (quality control) Lockout (89)
1 Introduction • 1

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CoaguChek® ProII · Operator’s Manual
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 starting with 9.1 Status /
Error messages (169).
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 note The 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 for the
CoaguChekPT Test or the aPTT Test, 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:
¾Parameter: aPTT
– seconds
¾Parameter: PT
1 Introduction • 1

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CoaguChek® ProII · Operator’s Manual
– 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 POCT1‑A 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 to
a hospital information system (HIS) or to a laboratory
information system (LIS). Refer to the manuals of the
Handheld Base Unit and of your DMS for technical
details.
Test principle The 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
1 Introduction • 1

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CoaguChek® ProII · Operator’s Manual
into customary coagulation units (depending on the
test, into INR, %Quick, or seconds) and the result is
displayed.
Contents of the pack The CoaguChek ProII pack contains the following
items:
¾CoaguChek ProII meter
¾Additional test strip guide cover (spare part)
¾Battery compartment cover
¾Universal Battery Pack
¾Power supply
¾Starshaped screwdriver
¾Operator’s Manual (printed version, not shown
here)
¾Manual CD ROM (contains PDF files of the
Operator’s Manual in other languages, not shown
here)
Check for completeness and transport damage
immediately after unpacking.
1 Introduction • 1

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CoaguChek® ProII · Operator’s Manual
u Related topics
• 3.4 Options setup (62)
1 Introduction • 1

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CoaguChek® ProII · Operator’s Manual
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 CoaguChek ProII
Operator’s Manual. Read these passages carefully.
Safety alert
rThe 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!
Warning…
r…indicates a hazardous situation that, if not
avoided, could result in death or serious injury.
CAUTION!
Caution…
r…indicates a hazardous situation that, if not
avoided, could result in minor or moderate injury.
NOTICE!
Notice...
...indicates a hazardous situation that, 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.
1 Introduction • 1

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CoaguChek® ProII · Operator’s 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.
Safety information Operator qualification
rOnly 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.
1 Introduction • 1

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CoaguChek® ProII · Operator’s Manual
WARNING!
Protection against infection and blood‑borne
pathogens
Healthcare professionals using the CoaguChek ProII
system to perform tests 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 CoaguChek ProII system. All parts of this
system should be considered potentially infectious
and are capable of transmitting blood‑borne
pathogens between patients and between patients
and healthcare professionals.
rUse gloves. Wear a new pair of clean gloves for
testing each patient and control test.
rWash hands thoroughly with soap and water
before putting on a new pair of gloves and
performing the next patient test.
rUse an auto‑disabling single‑use lancing device
for each patient.
rDispose of used lancets in a sturdy sharps
container with lid.
rDispose of used test strips from patient and
proficiency tests according to your institution’s
infection control policy.
rFollow all health and safety regulations in force
locally.
1 Introduction • 1

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CoaguChek® ProII · Operator’s Manual
CAUTION!
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.
rAlways use protective gloves.
rObserve the cautions given in the package inserts
of the reagents and cleaning/disinfection
solutions.
rIf a reagent, control, linearity, or cleaning/
disinfection solution comes into contact with your
skin, wash it off immediately with water.
rFollow all health and safety regulations in force
locally.
WARNING!
Avoidance of electrical shock, fire, and
explosions
rOnly 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.
rDo not use loose power sockets or damaged
power supply units, cables, plugs, or battery packs.
rDo not short circuit the power supply unit, the
Handheld Base Unit contacts, or the battery pack.
rDo not drop the CoaguChek ProII meter, the
power supply unit, or the battery pack and protect
these against shaking and vibrations.
1 Introduction • 1

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CoaguChek® ProII · Operator’s Manual
Disposal of the system 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.
General care NOTICE!
Clean the meter only with the solutions
recommended. 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 pack The 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!
rUse only the specially designed battery pack
provided by Roche Diagnostics. Using any other
type of battery may damage the system.
1 Introduction • 1