Roche Diagnostics UU18 Medical Device with WLAN b/g User Manual UserManual EN

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cobas h 232 POC system
Operator’s Manual
Manual version
Revision date
Changes
Version 1.0
2006-10
New document
Version 2.0
2009-09
Minor revisions from internal review
Version 3.0
2011-09
Update to SW 03; enhanced error messages
Version 4.0
2014-05
Added description of new OTS functionality,
miscellaneous minor revisions
Version 5.0
2015-xx
Transition to new meter hardware: 2D barcode
scanner; wireless LAN option; new battery
pack. Update to SW 04.00. Update of cleaning
and disinfection section; added safety information on battery packs; deleted appendix for
addresses; misc. editorial revisions.
cobas h 232 POC system
Operator’s Manual
Version 5.0
0 7469101001 (01) 2015-XX EN
© 2006-2015, Roche Diagnostics GmbH. 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.
ROCHE CARDIAC, COBAS, COBAS H and IQC are trademarks of Roche.
The Wi-Fi CERTIFIED Logo is a certification mark of the Wi-Fi Alliance.
On the packaging and on the identification plate of the meter 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 instrument.
Temperature limitation (Store at)
Manufacturer
Catalogue number
IVD
In vitro diagnostic medical device
This product fulfills the requirements of the European Directive 98/79/EC on
in vitro diagnostic medical devices
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).
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.
The user is fully responsible for the installation, use and upkeep of the cobas h 232 meter.
This page intentionally left blank.
Table of Contents
1.1
1.2
1.3
2.1
3.1
3.2
3.3
Introduction
The cobas h 232 meter.................................................................................................................
Test principle .....................................................................................................................................
Contents of the Pack ......................................................................................................................
Important safety instructions and additional information.........................................................
Safety information............................................................................................................................
Disposal of the system ...................................................................................................................
Battery pack .......................................................................................................................................
General care.......................................................................................................................................
Electrical safety ................................................................................................................................
Electromagnetic interference ......................................................................................................
Touchscreen.......................................................................................................................................
Local Area Network: protection from unauthorized access ............................................
Wired network connection ...........................................................................................................
Wireless connectivity ......................................................................................................................
Radiofrequency radiation exposure information..................................................................
Overview of the meter and its accessories.....................................................................................
Meter ...................................................................................................................................................
Power supply......................................................................................................................................
Test strip ..............................................................................................................................................
Handheld Base Unit ........................................................................................................................
Overview of the Buttons and Icons used on Screen...................................................................
Putting the Meter into Operation
Installing or replacing the battery pack...........................................................................................
Removing the battery pack ..........................................................................................................
Installing the battery pack ............................................................................................................
Powering the meter on and off ...................................................................................................
Meter Setup
Settings summary.............................................................................................................................
Basics setup ...............................................................................................................................................
Contrast ...............................................................................................................................................
Language ............................................................................................................................................
Setting the date.................................................................................................................................
Setting the time.................................................................................................................................
Setting the display options for date and time .......................................................................
Sound....................................................................................................................................................
Auto off ................................................................................................................................................
Data Handling setup ...............................................................................................................................
Connection ........................................................................................................................................
QR Code ..............................................................................................................................................
Computer.............................................................................................................................................
Printer ...................................................................................................................................................
Result memory ..................................................................................................................................
Result units.........................................................................................................................................
Result display mode ........................................................................................................................
Diagnostics.........................................................................................................................................
ID Setup setting ........................................................................................................................................
Administrator ID ...............................................................................................................................
Operator ID.........................................................................................................................................
Patient ID.............................................................................................................................................
11
11
13
13
14
15
17
17
19
19
20
20
20
21
22
22
24
24
27
29
30
31
35
36
37
38
41
43
44
49
49
51
53
55
57
59
62
64
64
65
68
69
71
75
78
80
82
83
89
92
Table of Contents
3.4 Lockout setup ............................................................................................................................................ 94
Operator lockout............................................................................................................................... 95
Quality control (QC) settings ....................................................................................................... 98
Quality control (QC) lockout ..................................................................................................... 100
Instrument quality control (IQC) lockout.............................................................................. 101
QC result format ............................................................................................................................ 102
Custom Range Troponin T ......................................................................................................... 103
Reset test parameters.................................................................................................................. 105
Cleaning lockout............................................................................................................................ 106
STAT test configuration .............................................................................................................. 107
3.5 Optional Screens setup ....................................................................................................................... 109
Performing a Test
113
Sample material ............................................................................................................................. 115
4.1 Preparing to test .................................................................................................................................... 115
Code chip ......................................................................................................................................... 116
Inserting the code chip .............................................................................................................. 117
Test steps (overview) ................................................................................................................... 118
Powering on the meter................................................................................................................ 119
Logging in ........................................................................................................................................ 120
4.2 Performing a test ................................................................................................................................... 123
Inserting a test strip .................................................................................................................... 127
Displaying, confirming or adding comments to results.................................................. 132
Displaying the test result as QR code ................................................................................... 135
STAT tests ........................................................................................................................................ 136
Control Testing and Quality Control
137
5.1 Preparing to run a quality control test .......................................................................................... 137
5.2 Performing a quality control test ..................................................................................................... 139
Quality control (QC) ..................................................................................................................... 139
Displaying the QC result as QR code .................................................................................... 146
Instrument quality control (IQC).............................................................................................. 147
Review Results
151
Reviewing test results.................................................................................................................. 151
Patient history................................................................................................................................. 153
All results.......................................................................................................................................... 154
Quality control (QC) results....................................................................................................... 155
Instrument quality control (IQC) results ............................................................................... 156
Maintenance history .................................................................................................................... 157
Extended Functionalities
159
Data handling ................................................................................................................................. 159
Computer (Setup option)............................................................................................................ 160
Operator lists................................................................................................................................... 161
Patient lists....................................................................................................................................... 162
Barcode scanner............................................................................................................................ 163
Stored test results and comments .......................................................................................... 163
Table of Contents
Maintenance and Care
8.1 Conditions for storage and shipping .............................................................................................
Storage..............................................................................................................................................
Shipping............................................................................................................................................
8.2 Cleaning and disinfecting the meter .............................................................................................
Difference between cleaning and disinfecting..................................................................
When should the meter be cleaned and disinfected? ....................................................
What to clean and disinfect? ....................................................................................................
Recommended cleaning/disinfecting agents.....................................................................
Cleaning/disinfecting the exterior (meter housing).........................................................
Cleaning after contamination due to mispipetting...........................................................
Cleaning the test strip guide cover ........................................................................................
Cleaning the visible area of the test strip guide................................................................
Troubleshooting
Errors and unusual behavior without error messages ....................................................
Meter reset ......................................................................................................................................
10
General Product Specifications
10.1 Operating conditions and technical data.....................................................................................
Technical data ................................................................................................................................
Sample material .............................................................................................................................
Storage and transport conditions ...........................................................................................
10.2 Further information...............................................................................................................................
Ordering information ...................................................................................................................
Product limitations........................................................................................................................
Information about software licenses ....................................................................................
Repairs ..............................................................................................................................................
11
Warranty
Appendix
A.1 Working with barcodes.......................................................................................................................
A.2 Operator and patient ID barcode masks......................................................................................
A.3 Example of barcode symbologies ...................................................................................................
A.4 Supported characters in 2D barcodes ..........................................................................................
Appendix
B.1 Option: Wireless network (WLAN) .................................................................................................
Preliminary note.............................................................................................................................
Background.....................................................................................................................................
Technical implementation..........................................................................................................
RF specific functionalities and effective performance claims......................................
Supplement for Observed Test Sequence
Observed Test Sequence (OTS) .............................................................................................
Using the OTS function...............................................................................................................
Contact Roche
Index
165
165
165
166
167
167
167
167
169
169
170
171
172
173
174
176
177
177
177
178
178
178
178
180
180
180
180
181
181
182
183
185
187
187
187
187
188
190
193
193
194
197
199
Table of Contents
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10
Introduction
Introduction
The cobas h 232 meter
The cobas h 232 meter is an instrument for the quantitative evaluation of immunoassays using
the gold-labeling technique. The rapid diagnostic tests in strip format available for this
meter support efficient diagnosis and assessment of cardiovascular diseases. The evaluation
of these tests with the cobas h 232 meter combines the advantages of a rapid diagnosis with
enhanced clinical interpretation of quantitative values (in comparison with qualitative tests). In addition,
automated evaluation provides more reliable results by eliminating the potential sources of error associated with visual reading. Refer to the package inserts accompanying the test strips for detailed
information on specific tests.
Readings may be carried out directly where the blood samples are taken. Therefore, the
cobas h 232 meter is ideal for use at the point of care in emergency rooms, intensive care units
and ambulances, as well as by cardiologists and general practitioners. The cobas h 232 meter is
rapid and easy to operate: Insert an unused strip in the meter and apply the sample. After the
reaction period, the meter provides a quantitative result; in addition, a qualitative result is provided prior to the end of some tests.
The cobas h 232 meter has the ability to connect to a data management system (DMS) by
means of wireless communication (if the meter is equipped with WLAN functionality) or through
the Handheld Base Unit from Roche Diagnostics (available separately). The cobas h 232 meter
supports data exchange via the POCT1A standard or directly via WLAN. 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 an LIS or HIS. Refer to the
manuals of the Handheld Base Unit and of your DMS for technical details.
11
Introduction
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 cobas h 232 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.
For all questions about the cobas h 232 system that are not answered in this manual, contact
your Roche representative (see “Contact Roche” on page 197). In order to expedite troubleshooting, please have ready your cobas h 232 meter, its serial number, this manual, and all related
consumables when you call.
If you connect your cobas h 232 meter to a cobas IT 1000 data management system or
another PC/DMS, you will not be able to print directly from the meter to a printer. In order to
print out meter data, use printers connected to the respective PC/DMS.
12
Introduction
Test principle
Two lines (signal and control line) in the detection zone of the test strip indicate whether the analyte to
be determined is present in the sample material. These lines are detected by the cobas h 232 meter
with the help of an LED (lighting the detection zone) and a camera sensor (imaging the detection
zone). The test signal (signal line) increases in intensity in proportion to the concentration of the
respective analyte. Integrated system software converts the signal intensity to a quantitative
result, which is then displayed on the screen at the end of the measurement.
The accuracy of the measurement is ensured through a simple principle: Every test strip box
includes a code chip that contains all test and lot-specific information in electronic format. The
test strips are labelled with a barcode on their underside and are hereby assigned to a specific
code chip. When you insert a test strip from a new strip lot for the first time, the meter prompts
you to plug in the corresponding code chip. The information is now read from the code chip and
stored for future tests.
Contents of the Pack
■
cobas h 232 meter
■
Power adapter
■
Universal Battery Pack
■
Operator’s manual in English
■
CD-ROM with operator’s manual in other languages
Optionally available (not included in the scope of delivery):
■
Handheld Base Unit (docking station) for data transfer within a network or via USB
(Universal Serial Bus)
For a personal printout of the operator’s manual in your language, contact your local Roche
organization (see Chapter A).
13
Introduction
1.1
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 cobas h 232 Operator’s 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
CAUTION
NOTICE
Indicates a hazardous situation which, if not avoided, could result in death
or serious injury.
Indicates a hazardous situation which, if not avoided, could result in
minor or moderate injury.
Indicates a hazardous situation which, if not avoided, may result in
damage to the system.
Important information that is not safety relevant is presented against a colored background
(without a symbol). Here you will find additional information on correct use of the meter or
useful tips.
Illustrations in this manual show two different kinds of hands:
Hand without glove
14
Hand with glove
Introduction
Safety information
Operator qualification
Only trained healthcare professionals may operate the cobas h 232
meter. Operators must also have received comprehensive instruction in
the operation, quality control, and care of the cobas h 232 meter.
Protection against infection and blood-borne pathogens
WARNING
Healthcare professionals using the cobas h 232 meter 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 cobas h 232 meter. 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.
■
Use gloves. Wear a new pair of clean gloves for testing each patient.
■
Wash hands thoroughly with soap and water before putting on a new
pair of gloves and performing the next patient test.
■
Dispose of used syringes, tubes, pipettes, test strips, and all other
materials coming into contact with blood according to your institution’s infection control policy.
■
Follow all health and safety regulations in force locally.
15
Introduction
Allergy or injury caused by reagents and other working solutions
CAUTION
Direct contact with reagents, detergents, cleaning/disinfection solutions,
or other working solutions may cause skin irritation or inflammation.
■
Always use protective gloves.
■
Observe the cautions given in the package inserts of the reagents and
cleaning/disinfection solutions.
■
If a reagent, control, or cleaning/disinfection solution comes into contact with your skin, wash it off immediately with water.
■
Follow all health and safety regulations in force locally.
Avoidance of electrical shock, fire, and explosions
WARNING
16
■
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 cobas h 232 meter, the power supply unit, or the
battery pack and protect these against shaking and vibrations.
Introduction
Disposal of the system
Infection by a potentially biohazardous instrument
WARNING
The cobas h 232 meter 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.
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 adapter).
NOTICE
Use only the specially designed battery pack provided by Roche Diagnostics. Using any other type of battery may damage the system.
17
Introduction
Possible hazards posed by the battery pack
WARNING
Damaged or swollen battery packs can overheat, catch fire, or leak.
Immediately cease use of cobas h 232 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 cobas h 232 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.
18
Introduction
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.
General care
NOTICE
Clean the meter only with the solutions recommended (see page 165).
Using other solutions may result in incorrect operation and possible failure of the system. Make sure that the meter is thoroughly dried after
cleaning and disinfecting.
Electrical safety
NOTICE
Never run the meter if the electrical power adapter or the attached cable
is visibly damaged. If there is any visible damage contact your local Roche
service for inspections.
19
Introduction
Electromagnetic interference
The 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
NOTICE
■
Use only your finger (even when wearing gloves) or special pens
designed for use with handheld devices to touch the screen elements.
Using pointed or sharp-edged objects can damage the touchscreen.
■
Do not use the system in direct sunlight. Direct sunlight may reduce
the life expectancy and functionality of the screen.
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 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.
20
Introduction
Wired network connection
If connected to a local area network, the cobas h 232 Handheld Base Unit must be protected
against unauthorized access by means of a strong password management. Observe your own
facility guidelines on password management where available, or apply the following rules:
Characteristics of strong passwords
■
Passwords must not contain the user’s account name or parts of the user’s full name that
exceed two consecutive characters.
■
Passwords must be at least eight characters in length.
■
Passwords must contain characters from at least three of the following four categories:
–
–
–
–
English uppercase alphabetic characters (A through Z)
English lowercase alphabetic characters (a through z)
Numeric characters (0 through 9)
Non-alphabetic characters (for example, !, $, #, %)
Examples of weak passwords
■
uhxwze11 contains no upper case letter.
■
UHXW13SF contains no lower case letter.
■
uxxxxx7F contains the same character more than four times.
■
x12useridF contains a substring of the user ID longer than four characters.
To ensure that your cobas h 232 meter functions properly, observe the operating and storage
conditions as given in the chapter “General Product Specifications”, starting on page 177.
21
Introduction
Wireless connectivity
If the meter is equipped with WLAN functionality:
Wireless connectivity allows the meter to send data (test results, patient IDs, operator IDs, etc.) to
the data management system without the need to return the meter to the 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 cobas h 232
meter’s ability to connect to Wireless Local Area Networks (WLAN, Wi-Fi), see appendix B.
Radiofrequency radiation exposure information
Glossary:
■
“FCC” stands for “Federal Communications Commission” (USA).
■
“RF” stands for “radio frequency”
■
“RSS” stands for “Radio Standards Specification” (Canada).
■
“WLAN” stands for “Wireless Local Area Network”
The Industrial, Scientific and Medical (ISM) radio frequencies may contain emissions from microwave ovens, heaters, and other noncommunication devices. While these types of devices usually
pose no threat of interference as they are low-powered devices, the possibility exists that some
industrial high power systems may wipe out any attempted communication use of a WLAN.
Therefore, perform a site survey and interference analysis with a spectrum analyzer to view the
entire spectrum, looking for signals that might not only be within the frequency range of the
intended WLAN but also could be near or at the same frequency and cause interference.
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.
22
Introduction
The cobas h 232 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.
The cobas h 232 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.
23
Introduction
1.2
Overview of the meter and its accessories
Meter
24
Introduction
A Touchscreen
Shows results, information, icons and
results saved in the memory. To select an
option, simply touch the button lightly.
B On/Off button
Press this button to power the meter on or
off.
C Opening for sample application
Opening in the test strip guide cover that
enables you to apply blood once the test
strip is inserted.
D Test strip guide cover
Remove this cover to clean the area
underneath (if it has become soiled, e.g.,
with blood).
Barcode scanner (LED)
Operator and patient IDs can be read into
the meter using the integrated barcode
scanner (only meter versions with a serial
number greater than 200 000).
Battery compartment cover
Remove to insert the battery pack.
G Meter identification plate
See page 5 for symbol explanation.
H Wireless LAN label
If the meter supports wireless connectivity: This label displays registration numbers that are specific to the meter RF
hardware.
25
Introduction
Test strip guide
Insert the test strip here.
Infrared (IR) window
Supports data communication with the
(optional) Handheld Base Unit. Covered
by the semi-transparent rear panel.
M Charging terminals
Used for power supply and/or charging
the battery pack when the meter is
docked in the (optional) Handheld Base
Unit.
K Connection socket for power adapter
Plug in the power adapter here.
26
Code chip slot
Insert the code chip here.
Introduction
Power supply
N Battery Pack
Powers the device.
O Power adapter
Powers the device and charges the
battery pack.
The meter can be operated with the rechargeable battery pack only or together with the power
adapter or the (optional) Handheld Base Unit, which both charge the battery pack when inserted.
Insert the battery pack even when always using the power adapter or the Handheld Base Unit.
This ensures that you will not lose the date and time settings if the power goes out. Results are
retained in the memory together with the corresponding date and time, as well as all other settings, even when no battery pack is inserted.
To save power, the meter can automatically power itself off after a programmable period of time,
if no buttons are pressed or new test strips are inserted. When the meter powers itself off, all test
results obtained up to that point remain in memory and the settings are retained (see “Auto off”
in the chapter entitled “Data Handling setup” on page 62).
27
Introduction
09:15 am
Main Menu
Patient Test
Control Test
During battery operation, the meter always
displays the power level of the battery pack.
The battery icon is divided into four segments
which correspond to the battery power level.
When replacing the battery pack, insert the
new battery pack within 24 hours of removing
the old one. Otherwise you may need to reenter date and time.
Review Results
Setup
Logout
04/19/2015
Dispose of used battery packs in an environmentally responsible manner
in accordance with applicable local regulations and directives. See
“Infection by a potentially biohazardous instrument” on page 17.
28
Introduction
Test strip
P Test area
This area is evaluated by the meter via the
camera.
Q Sample application area
The sample is applied to this area after
inserting the test strip in the meter.
R Barcode
Assigns the strip to the corresponding
code chip. The barcode is automatically
read by the meter when the strip is
inserted into the test strip guide.
S Code chip
Contains strip lot specific data.
29
Introduction
Handheld Base Unit
Charging contacts
Used for power supply and/or charging
the battery pack.
U Status indicator
Lights up when power is connected,
charge indicator.
V Infrared (IR) window
For communication with the meter.
W Extension piece
For cobas h 232 meter.
X Data ports (Ethernet/RJ45 and USB)
For connecting the device to a Data
Management System (DMS).
Y Connection socket for the
power adapter
Here you can plug in the power adapter of
the Handheld Base Unit.
Z Removable cover for configuration
switch
The switch sets the mode of operation for
the Handheld Base Unit.
The Handheld Base Unit can be ordered separately. For detailed information on usage and
configuration please consult the operator's manual of the Handheld Base Unit and the
Technical Note stored on the Handheld Base Unit itself.
30
Introduction
1.3
Overview of the Buttons and Icons used on Screen
The buttons and icons that appear during normal operation are shown here, along with a general
explanation. Error messages and the description of the icons linked to them are provided in a
separate chapter. See “Troubleshooting” starting on page 173.
Button/Icon
Meaning
OK, save setting
Cancel, discard setting
Return (to previous menu)
Decrease/increase a numeric value or
Scroll through lists that are too long to be displayed at once
Inactive button; value cannot be further decreased/increased or
End of list in this direction is reached
Return to the Main Menu screen
List of tests of an individual patient
Scroll through stored results
Print displayed result (via infrared interface to corresponding printer)
Display test result as QR code
Add a comment
Operator logout
Operator login
Operator must wait until the meter has completed an action.
Insert test strip
Remove test strip
Test strip warming up
Apply sample (the time left to apply sample is counted down in the
screen alongside the required sample amount)
31
Introduction
Button/Icon
Meaning
Apply QC sample (the time left to apply sample is counted down in the
screen alongside the required sample amount)
QC
Insert code chip
Open test strip guide cover for cleaning
Battery status:
• If the battery pack still has its full charge, all segments are lit
• Individual segments disappear one by one as the battery pack
becomes weaker
• When there is no segment remaining, you can no longer perform
a test. You can, however, still access the meter’s memory
Operation with power adapter
am
Time between midnight and noon (in 12-hour time format)
pm
Time between noon and midnight (in 12-hour time format)
Marks an information message
Marks an error message or a warning
(see Chapter 9 “Troubleshooting”)
Room or meter temperature is outside the acceptable range.
The test strip guide cover is open.
QC!
32
In a QC lockout condition, this icon indicates that one or more
parameters are locked, while others still can be measured.
Introduction
The following icons may appear when using the meter in conjunction with a data management
system (DMS).
Infrared interface is enabled (for communication with the computer
and/or printer)
Communication is taking place via WLAN
An OTS request is pending
Cleaning/Disinfection necessary
33
Introduction
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34
Putting the Meter into Operation
Putting the Meter into Operation
Before using the meter for the first time, perform the following steps:
Install the battery pack (see page 38)
Connect the power adapter to charge the battery pack
Set the current date and time as well as the appropriate display format (see Chapter “Meter
Setup” starting on page 43)
Enter the settings of choice (language, quality controls – where necessary, user
administration, etc.)
If the meter has no date/time settings (either because you are powering on the meter for
the first time or because the battery pack was removed from the meter for more than 24
hours), you cannot perform a test. In that case powering on the meter takes you immediately
to the Setup mode, where you must set the date and time.
35
Putting the Meter into Operation
2.1
Installing or replacing the battery pack
When shipped, the battery pack is not installed in the meter.
Unused battery packs lose their charge over time and have to be recharged before they can
be used. After installing a new battery pack, the meter should be charged overnight before
testing. Please note that the battery pack will only reach full capacity once it has been fully
emptied and charged several times.
Whenever the meter is placed on an active Handheld Base Unit or powered by the power
adapter, the
icon is displayed. This icon shows that power is available and the meter
can be charged if necessary.
Make sure that the permitted temperature range for charging the battery pack (12-32 °C or
54-90 °F) is maintained during installation and initial setup.
36
Putting the Meter into Operation
Removing the battery pack
If a battery pack is already installed, make
sure that the meter is powered off.
Place the meter face down on a level surface.
Using a an appropriate starshaped screwdriver, e.g. Torx® size T5, remove the four
screws holding the battery compartment
cover in place.
Remove the battery compartment cover
from the meter. The battery pack now visible is connected to the meter by a plug.
Carefully lift the battery pack and remove
the plug connector.
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.
37
Putting the Meter into Operation
Installing the battery pack
Loosen the screws on the battery compartment cover until they are protruding
about 4-5 mm (2/10 in).
Hold the battery pack in your hand, with
the wires and the plug pinched between
your thumb and index finger.
Plug the connector plug into the socket
and make sure it is fully inserted.
Place the battery pack inside the battery
compartment as shown.
To position the battery pack correctly, always
align the ridges on the side of the battery pack
with the ridges on the inside of the battery
compartment.
38
Putting the Meter into Operation
Place the cover on the battery compartment. Make sure that the plug connector
wires do not get pinched between meter
and cover.
Tighten all four screws until snug (do not
overtighten).
39
Putting the Meter into Operation
After inserting a new battery pack, the meter powers on automatically.
■
The Roche logo is displayed. If the meter
does not power on automatically, the battery pack may be empty. Connect the
power adapter for a minimum of 30 minutes, then remove the plug and try to
power the meter on. If it powers on, the
battery pack is charging properly.
■
Within a short period of time, the start
screen should appear.
■
If the meter has been without power for
too long, it will show the date and time
settings dialog and you have to re-enter
the date and time settings.
■
The screens for entering the date and the
time appear.
Enter the date and time. After you have
entered the correct information, confirm
each screen with
Set Date
Year:
2015
Month:
Day:
1Hour:
Set Time
04/19/2015
Minutes:
49
AM
04/19/2015
PM
After installing a new battery pack, the meter should be charged overnight before testing.
40
Putting the Meter into Operation
Powering the meter on and off
Power the meter on by pressing the
button for approximately 1 second.
You can also power on the meter directly by
connecting the power adapter or by placing
the meter on the Handheld Base Unit.
To power the meter off after use, press the
button for approximately 1 second.
41
Putting the Meter into Operation
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42
Meter Setup
Meter Setup
Buttons are screen prompts that cause something to happen when touched. In this manual the
names of all buttons are either shown as bold text or as the icon used on the button (e.g.,
for
OK ).
When text refers to other screen elements (e.g., Menu titles), these are written in italics. These
screen elements are not active.
You can open any displayed function by
touching (or tapping) the button for it with
your finger (or a special pen for this purpose).
“Tap” means: Touch the button, then remove
your finger from the touchscreen. The next
screen appears once you remove your finger.
Main Menu
09:15 am
Setup
Basics
Patient Test
Data Handling
Control Test
ID Setup
Review Results
Lockout
Setup
Optional Screens
04/19/2015
Touch Setup to call up the Setup menu.
Select the group of settings of choice
(see the Settings summary following this
section).
For a description of the buttons and icons
used on screen see page 31.
04/19/2015
43
Meter Setup
Settings summary
The diagram below gives an overview of the setup areas that can be accessed on the meter.
Setup
Basics
Contrast
Language
Date/Time
Sound
Auto Off
Data
Handling
Connection
Result Memory
DD Result Unit
Result Display
Mode
ID Setup
Administrator ID
Operator ID
Patient ID
Lockout
Operator
Lockout
QC Settings
Cleaning
Lockout
Start Info
Result Login
Result
Confirmation
Optional
Screens
44
STAT Test Config.
Meter Setup
Group
Basics
Subgroup
Contrast
Setting
Values *
0 – 10 (5*)
Dansk
Language
Deutsch
English *
Español
Français
Italiano
Nederlands
Norsk
Português
Svenska
An installable language
Date/Time
Date
01/01/2011 *
Time
12:00 am *
Date formats
Day.Month.Year (31.12.2011)
Month/Day/Year (12/31/2011) *
Year-Month-Day (2011-12-31)
Time formats
24-hour time format (24H)
12-hour time format (12H),
with am/pm *
Sound (Beeper)
Volume
Off
Low
Medium *
High
Key Click
Enable
Disable *
Auto Off
[minutes]
Off
1 … 10 (default: 5 min *)
15, 20, 25, 30
40, 50, 60
* Default settings are labelled with an asterisk (*).
45
Meter Setup
Group
Data Handling
Subgroup
Connection
Setting
Values *
QR Code
Off *
Computer
Printer
Result Memory
Result Display Filter All results *
Current Op. Res.
Result Unit
Result Storage
Mode
No results deletion *
Select DD Res. Unit
μg/mL *
Delete oldest result
ng/mL
mg/L
μg/L
Select TT Res. Unit
ng/L *
pg/mL
ng/mL
μg/L
Static *
Result Display Mode
Flashing
ID Setup
Blank (off) *
Administrator ID
Operator ID
(with DMS and list
available on meter)
None *
List
Hidden List
(No list available on
meter)
None *
Optional
Required
Scan Only
Patient ID
None
Optional *
Required
Hidden List
* Default settings are labelled with an asterisk (*).
46
Meter Setup
Group
Lockout
Subgroup
Setting
Operator Lockout (only if “Operator ID”
option is enabled)
Values *
No *
Daily
Weekly
Monthly
Every 3 months
Every 6 months
Yearly
QC Settings
QC Lockout
New Lot: Yes/No *
No *
Daily
Weekly
Monthly
IQC Lockout
No *
Daily
Weekly
Monthly
QC Result Format
Pass/Fail *
Value
Value & Pass/Fail
Custom Range
Trop T
Default Range*
Reset Test Param.
Do Reset
Custom Range
No Reset *
Cleaning Lockout
No *
Daily
Weekly
Monthly
STAT Test Config.
Enable
Disable *
* Default settings are labelled with an asterisk (*).
47
Meter Setup
Group
Optional screens
Subgroup
Start Info
Setting
Values *
Enable
Disable *
Result Login
Enable
Disable *
Result Confirmation
Enable
Disable *
* Default settings are labelled with an asterisk (*).
48
Meter Setup
3.1
Basics setup
The Basics setup area contains the basic options for changing the user interface.
Contrast
Use the Contrast menu to adjust the display to your ambient light conditions and make it easier
to read.
09:15 am
Main Menu
Patient Test
Control Test
Review Results
From the Main Menu, touch Setup to
open the meter settings.
From the Setup menu, touch Basics.
From the Setup-Basics menu, touch
Contrast.
Setup
Setup
Basics
04/19/2015
Data Handling
ID Setup
Lockout
Optional Screens
Setup - Basics
Contrast
04/19/2015
Language
Date/Time
Sound
Auto Off
04/19/2015
49
Meter Setup
Touch
or
to change the contrast in
a range from 0 to 10.
■
Contrast “0” makes the screen very dark.
■
Contrast “10” makes the screen very light.
Touch
to save this setting, or touch
to exit this menu without saving any
changes. The display automatically
returns to the previous screen.
Select Contrast
Contrast:
(0-10)
04/19/2015
50
Meter Setup
Language
Use this setting to select the language for all displays (that contain text).
09:15 am
Main Menu
Patient Test
Control Test
From the Main Menu, touch Setup to
open the meter settings.
From the Setup menu, touch Basics.
From the Setup-Basics menu, touch
Language.
Review Results
Setup
Setup
The current language setting is highlighted
(white type on a blue background). You can
select either:
Basics
04/19/2015
Data Handling
ID Setup
■
Dansk
Lockout
■
Deutsch
■
English
Optional Screens
Setup - Basics
■
Español
Contrast
■
Français
Language
■
Italiano
Date/Time
■
Nederlands
Sound
■
Norsk
Auto Off
■
Português
■
Svenska
04/19/2015
04/19/2015
An optional language can be installed upon
request (either directly at the plant or later by
an authorised Roche Diagnostics service
technician).
51
Meter Setup
Touch
or
to display the language
of choice on the screen.
Select Language
Français
Italiano
Nederlands
If the arrow is just an outline
, you
have reached the end of the list in the respective direction.
Touch the button to select the language of
choice. Your selection is now highlighted.
Touch
to save this setting, or touch
to exit this menu without saving any
changes. The display automatically
returns to the previous screen.
Norsk
Português
04/19/2015
52
Meter Setup
Setting the date
Use this menu to set the date of the meter.
09:15 am
Main Menu
Patient Test
Control Test
Review Results
From the Main Menu, touch Setup to
open the meter settings.
From the Setup menu, touch Basics.
From the Setup-Basics menu, touch
Date/Time.
Setup
Setup
Basics
04/19/2015
Data Handling
ID Setup
Lockout
Optional Screens
Setup - Basics
Contrast
04/19/2015
Language
Date/Time
Sound
Auto Off
04/19/2015
53
Meter Setup
Setup - Date/Time
From the Setup-Date/Time menu, touch
Date to set the date.
Touch
or
to set the year, then the
month, then the day.
Touch
to save this setting, or touch
to exit this menu without saving any
changes. The display automatically
returns to the previous screen.
Date
Set Date
Time
Year:
Date/Time Format
2015
Month:
Day:
04/19/2014
04/19/2015
If the Set Date menu appeared automatically
after powering the meter on, you must touch
to complete the date setting. The Set Time
menu will then be displayed next.
54
In the Setup-Date/Time menu, touch
to return to the Setup-Basics menu or
touch Time to move to the time setting.
Meter Setup
Setting the time
Use this menu to set the time of the meter.
09:15 am
Main Menu
Patient Test
Control Test
Review Results
From the Main Menu, touch Setup to
open the meter settings.
From the Setup menu, touch Basics.
From the Setup-Basics menu, touch
Date/Time.
Setup
Setup
Basics
04/19/2015
Data Handling
ID Setup
Lockout
Optional Screens
Setup - Basics
Contrast
04/19/2015
Language
Date/Time
Sound
Auto Off
04/19/2015
55
Meter Setup
Setup - Date/Time
From the Date/Time menu, touch Time to
set the time.
Touch
or
minutes.
Touch
to save this setting, or touch
to exit this menu without saving any
changes. The display automatically
returns to the previous screen.
Date
Set Time
Time
Hour:
Date/Time Format
Minutes:
49
AM
04/19/2014
04/19/2015
PM
If the Set Time menu appeared automatically
after leaving the Set Date menu, you must
touch
to complete the time setting. The
Main Menu will then be displayed next.
56
to set the hours, then the
Touch
to return to the Setup-Basics
menu or touch Date/Time Format to
move to the display options.
Meter Setup
Setting the display options for date and time
Select your preferred format for the date and time display.
09:15 am
Main Menu
Patient Test
Control Test
Review Results
From the Main Menu, touch Setup to
open the meter settings.
From the Setup menu, touch Basics.
From the Setup-Basics menu, touch
Date/Time.
Setup
Setup
Basics
04/19/2015
Data Handling
ID Setup
Lockout
Optional Screens
Setup - Basics
Contrast
04/19/2015
Language
Date/Time
Sound
Auto Off
04/19/2015
57
Meter Setup
Setup - Date/Time
Date
Time
Select Date Format
Date:
DD.MM.YYYY
Date/Time Format
MM/DD/YYYY
YYYY-MM-DD
Time:
04/19/2014
04/19/2015
From the Setup-Date/Time menu screen,
touch Date/Time Format to set the display format.
24H 12H
The current settings are highlighted (white
type on a blue background). You can select
one of the following display formats for the
date:
■
Day.Month.Year, e.g., 31.12.2011
■
Month/Day/Year, e.g., 12/31/2011
■
Year-Month-Day, e.g., 2011-12-31
You can also select one of the following display formats for the time:
58
■
24H (24-hour time format), e.g., 14:52
■
12H (12-hour time format, supplemented
by am/pm), e.g., 2:52 pm
Touch the button with the display format
of choice for the date and time. Your
selection is now highlighted.
Touch
to save this setting, or touch
to exit this menu without saving any
changes. The display automatically
returns to the previous screen.
Touch
menu.
to return to the Setup-Basics
Meter Setup
Sound
The cobas h 232 meter can display information visually and alert you to special circumstances
with a beep sound. When the Sound is activated, the meter beeps when:
■
it is powered on
■
it detects a test strip
■
pre-heating of the test strip is complete and you need to apply a sample
■
the test is completed and the results are displayed (a long beep)
■
an error occurs (three short beeps)
■
the power adapter is connected when the meter is on
■
a barcode is scanned successfully (short beep)
■
the barcode scanner is disabled (two short beeps)
■
a positive test result can be expected, while the measurement still is in progress (a long
beep)
We recommend that you keep the Sound (beeper) activated at all times.
You can also activate a Key Click. When the Key Click is activated, the meter clicks briefly every
time a button is touched, facilitating the input of information.
59
Meter Setup
09:15 am
Main Menu
Patient Test
Control Test
Review Results
Setup
Setup
Basics
04/19/2015
Data Handling
ID Setup
Lockout
Optional Screens
Setup - Basics
Contrast
04/19/2015
Language
Date/Time
Sound
Auto Off
04/19/2015
60
From the Main Menu, touch Setup to
open the meter settings.
From the Setup menu, touch Basics.
From the Setup-Basics menu, touch
Sound.
Meter Setup
Setup - Sound
Volume
Key Click
Select Volume
From the Setup-Sound menu, touch
Volume to set the volume level of the
beeper.
Off
Low
Medium
High
04/19/2015
04/19/2015
Key Click
The current setting is highlighted (white type
on a blue background). You may select from
the following options:
■
Off
■
Low
■
Medium
■
High
Touch Key Click in the Setup-Sound
menu to turn the key click on or off.
Enable
You may select from the following options:
Disable
■
Enable
■
Disable
Touch
to save this setting, or touch
to exit this menu without saving any
changes. The display automatically
returns to the previous screen.
Touch
menu.
04/19/2015
to return to the Setup-Basics
61
Meter Setup
Auto off
You can set up your meter so that it powers itself off automatically if it has not been used (no
buttons touched or tests run) for a preselected time period. Use this feature to save power and
extend the life of the batteries.
09:15 am
Main Menu
Patient Test
Control Test
Review Results
From the Main Menu, touch Setup to
open the meter settings.
From the Setup menu, touch Basics.
In the Setup-Basics menu, touch Auto
Off.
Setup
Setup
Basics
04/19/2015
Data Handling
ID Setup
Lockout
Optional Screens
Setup - Basics
Contrast
04/19/2015
Language
Date/Time
Sound
Auto Off
04/19/2015
If the meter is connected to the power adapter or the Handheld Base Unit, the Auto Off function has a different effect:
■
If you do not work with operator IDs, the meter switches to the Main Menu, once Auto Off
is triggered.
■
If you work with operator IDs, the meter switches to Operator Login, once Auto Off is
triggered.
For information on Operator ID, see “Operator ID” on page 89.
62
Meter Setup
You may select from the following options:
Set Auto Off Time
Minutes:
04/19/2015
■
Off (meter never powers itself off)
■
Time until meter powers itself off:
1…10, 15, 20, 25, 30, 40, 50, 60 minutes
Touch
or
to select the time of
choice in minutes or to deactivate the
feature.
Touch
to save this setting, or touch
to exit this menu without saving any
changes.
The display automatically returns to the
previous screen.
Touch
to return to the Setup menu.
63
Meter Setup
3.2
Data Handling setup
Connection
In the Connection menu you can configure the data exchange with external devices. The meter
can be connected either to a computer or a printer. In addition to this direct data output, test
results may also be encoded as QR codes, which can be scanned to be used with other applications.
09:15 am
Main Menu
Patient Test
From the Main Menu, touch Setup to
open the meter settings.
From the Setup menu, touch Data
Handling.
From the Setup-Data Handling menu,
touch Connection.
Control Test
Review Results
Setup
Setup
Basics
04/19/2015
Data Handling
ID Setup
Lockout
Optional Screens
Setup - Data Handling
Connection
04/19/2015
Result Memory
Result Units
Result Display Mode
Diagnostics
04/19/2015
64
Meter Setup
QR Code
Connection
QR Code
09:15 am
Show QR code:
From the Connection menu, touch QR
Code.
Touch On to enable, or touch Off to disable QR code display. Your selection is now
highlighted.
■
If you have enabled this feature, select the
style of the QR code to be displayed:
■
Plain Text
Use this option to scan the result into a PC
hosted application (e.g. electronic medical record). In order to do so, you need an
external 2D barcode scanner attached to
your PC. Once scanned, the test result and
related meta-information (e.g. date, time,
comments) will appear as plain text in
your PC application.
■
Coded Data
Use this option to scan the result into a
smartphone or tablet app, or a PC hosted
application.
■
URL Transmission
Use this option to upload the result to a
web based service (e.g. such as an electronic health record, etc.). For this option
further parameters (URL, encryption key)
must be set.
09:15 am
QR Code
On
Off
Off
Computer
Printer
Plain Text
Coded Data
URL Transmission
04/19/2015
04/19/2015
65
Meter Setup
Ensure that your environment for reading QR codes (QR code reader, operating system, text
processing application) is appropriate for your language. Disregard may lead to unpredictable
behavior of your receiving component (PC, mobile device).
For the options Coded Data and URL Transmission dedicated software programs or apps are
required in order to use this feature. If you are a customer or a 3rd party IT provider, and you
are interested to use this feature, contact your local Roche Diagnostics representative for
additional information.
09:15 am
QR Code
Show QR code:
On
Off
Plain Text
If you have selected URL Transmission, the
button will become active. Use this button
to set the additional parameters.
Coded Data
URL Transmission
URL Transmission
09:15 am
Touch
to open the URL Transmission menu.
Touch URL to enter the URL to which
the test result data will be uploaded
(note: the URL will be provided by your
specialized service provider).
■
Use
123
to switch to input of numbers.
■
Use
ABC
to switch back to input of text.
■
Use
to backspace and correct a
mistake.
04/19/2015
URL
Encryption Key
09:15 am
URL
04/19/2015
66
Touch Plain Text, Coded Data or
URL Transmission, depending on the
intended use. Your selection is now
highlighted.
123
Touch
to save this setting, or touch
to exit this menu without saving any
changes. The display automatically
returns to the previous screen.
Meter Setup
URL Transmission
09:15 am
Encryption Key
URL
Encryption Key
09:15 am
Key:
JD5G29F6U8V2WC4L
Serial No.:
UQ85464711
Note: The encryption key and
the serial number are required
to decrypt QR code messages
from this meter. Ensure they
are available on the target
system.
04/19/2015
10 Touch Encryption Key to display the
Encryption Key menu.
The Encryption Key menu displays two types
of information which are required in order to
identify and decode the transmitted test
result. This information is required by the IT
system, to which the test result is transmitted
via the defined URL.
■
Key
This key is auto-generated by the meter
and is required to decrypt the QR code
information.
■
Serial No.
The meter's serial number is required to
map the test result to the encryption key.
04/19/2015
Touch the New button, if you want the
meter to generate a new encryption key.
11 Touch
menu.
twice to return to the QR Code
12 Touch
to save this setting, or touch
to exit this menu without saving any
changes. The display automatically
returns to the previous screen.
The Encryption Key information needs to be exchanged once with your specialized service provider prior to using the URL transmission method. Contact your specialized service provider in
order to exchange this information.
67
Meter Setup
Computer
The cobas h 232 meter can connect with a computer or host system running appropriate software (that is, a DMS must be installed). To use this connectivity feature, however, you need the
optional Handheld Base Unit or the meter must be configured for wireless communication. If no
wireless communication is configured, the connection is established in two steps.
■
The meter connects to the Handheld Base Unit via infrared.
■
The Handheld Base Unit is either connected to a single computer (via USB) or to a network/host system (via Ethernet).
The option Computer (when activated) can be used together with a DMS to set up:
■
operator lists, or
■
patient lists (lists of patients to be tested)
This eliminates the need for manual entry of these data. In addition, you can transfer test results
stored in the meter to other systems for archiving or further evaluation. The option Computer
controls the meter’s ability to communicate with a computer or a network.
Connection
QR Code
Off
Computer
09:15 am
13 From the Connection menu, touch
Computer. Your selection is now highlighted.
14 Touch
to save this setting, or touch
to exit this menu without saving any
changes. The display automatically
returns to the previous screen.
Printer
04/19/2015
Extended data handling functionality is dependent on the capabilities of the particular Data
Management System (DMS) being used and may vary.
68
Meter Setup
Printer
The meter can connect directly with three different infrared printers. The Handheld Base Unit
cannot be used for this purpose.
The option to print is displayed in a test result as well as directly after a test and when calling up
stored results. Using the settings you enter here, you can activate or deactivate the meter‘s ability to
print.
Connection to a printer can only be established via infrared.
Enabling the connection to a printer disables the connection to a computer (and vice versa).
Connection
09:15 am
QR Code
Select Printer
Off
Citizen CMP-10
Computer
GeBE GPT-437x
Printer
Zebra MZ 320
15 From the Connection menu, touch
Printer. Your selection is now highlighted.
16 Touch
to confirm the selection. The
next screen allows you to choose the type
of printer you are using.
17 Touch
to save this setting, or touch
to exit this menu without saving any
changes. The display automatically
returns to the previous screen.
04/19/2015
04/19/2015
69
Meter Setup
Pat. Test - Result
Pat:
Op:
Par:
PID111SCHULZM457
SCHULZ, MANFRED
JONES, TOM
Code: PB1234
proBNP
01/25/2015 10:17
620 pg/ml
To print :
■
Align the meter with the IR printer
■
At any test or memory screen,
touch
The printer icon only appears if the printer
function is activated. Otherwise it is not
displayed.
04/19/2015
Note: (Only applies if you are working with the
meter in a language other than English.) With
the exception of information you have entered
(such as patient ID and name, operator ID,
comments), the printout will be in English.
70
Meter Setup
Result memory
Result memory settings allow to apply a Result Display Filter and to set the Result Storage Mode
(see page 73).
All results recorded by the meter (patient results and quality controls) are stored automatically.
Use the Sel. Res. Display Filter menu to select whether to display results (when calling up the
Memory function) for all existing tests or only those from the current operator.
09:15 am
Main Menu
Patient Test
From the Main Menu, touch Setup to
open the meter settings.
From the Setup menu, touch Data
Handling .
From the Setup-Data Handling menu,
touch Result Memory.
Control Test
Review Results
Setup
Setup
Basics
04/19/2015
Data Handling
ID Setup
Lockout
Optional Screens
Setup - Data Handling
Connection
04/19/2015
Result Memory
Result Units
Result Display Mode
Diagnostics
04/19/2015
71
Meter Setup
Setup - Result Memory
Result Display Filter
Result Storage Mode
Sel. Res. Display Filter
All Results
Current Op. Res.
04/19/2015
04/19/2015
72
From the Setup-Result Memory menu,
touch Result Display Filter to select the
results to display.
The current setting is highlighted (white type
on a blue background). You may select from
the following options:
■
All Results
■
Current Op(erator) Res(ults)
Touch
to save this setting, or touch
to exit this menu without saving any
changes. The display automatically
returns to the previous screen.
Touch
to return to the Setup-Data
Handling menu.
Meter Setup
The Sel. Res. Storage Mode menu tells the meter what to do when the memory is full.
The meter memory can store a maximum of 2000 patient tests, 500 liquid controls, and 200
instrument quality controls.
In case of a full memory, you can choose between:
■
No Result Deletion. This prevents data from being deleted inadvertently, but may (in case
of a full memory) lead to the situation that you cannot perform a new measurement. Further measurements will only be possible if stored data are transferred to the data management system (DMS) or you allow automatic deletion.
■
Del. Oldest Result. Based on the 1st in/1st out principle, the oldest result will be automatically deleted when necessary. This is the only option if the meter is used without a
DMS (i.e. no data will be transferred and archived).
The option No Result Deletion is available only when you are using a DMS. For more details
see “Extended Functionalities”, starting on page 159. If you are not working with a DMS, this
option is set to Del. Oldest Result.
However, you only can select between these two options, if the meter is used together with a
DMS and the Computer connection is enabled. In this case data stored in the meter are flagged,
as soon as they have been transferred to the computer. Now the meter is allowed to delete those
flagged data when necessary, even if you have selected the No Result Deletion option.
73
Meter Setup
Setup - Result Memory
Result Display Filter
Result Storage Mode
Sel. Res. Storage Mode
No Result Deletion
You may select from the following options:
Del. Oldest Result
■
No Result Deletion
■
Del(ete) Oldest Result
Touch
to save this setting, or touch
to exit this menu without saving any
changes. The display automatically
returns to the previous screen.
Touch
to return to the Setup-Data
Handling menu.
04/19/2015
04/19/2015
74
From the Setup-Result Memory menu,
touch Result Storage Mode to select
your storage mode.
Meter Setup
Result units
The result unit setting applies to the result display of D-Dimer and Troponin T tests only.
09:15 am
Main Menu
Patient Test
From the Main Menu, touch Setup to
open the meter settings.
From the Setup menu, touch Data
Handling.
From the Setup-Data Handling menu,
touch Result Units.
Control Test
Review Results
Setup
Setup
Basics
04/19/2015
Data Handling
ID Setup
Lockout
Optional Screens
Setup - Data Handling
Connection
04/19/2015
Result Memory
Result Units
Result Display Mode
Diagnostics
04/19/2015
75
Meter Setup
Setup - Result Units
From the Setup-Result Units menu, touch
DD Result Unit.
From the Select DD Res. Unit menu, select
the unit to be used for the D-Dimer result
display.
DD Result Unit
TT Result Units
Select DD Res. Unit
µg/mL
ng/mL
mg/L
04/19/2015
µg/L
04/19/2015
76
The current setting is highlighted (white type
on a blue background). You may select from
the following options:
■
μg/mL
■
ng/mL
■
mg/L
■
μg/L
Touch
to save this setting, or touch
to exit this menu without saving any
changes. The display automatically
returns to the previous screen.
Meter Setup
Setup - Result Units
From the Setup-Result Units menu, touch
TT Result Unit.
From the Select TT Res. Unit menu, select
the unit to be used for the Troponin T
result display.
DD Result Unit
TT Result Units
Select TT Res. Unit
µg/mL
ng/mL
mg/L
04/19/2015
The current setting is highlighted (white type
on a blue background). You may select from
the following options:
µg/L
04/19/2015
■
ng/L
■
pg/mL
■
ng/mL
■
μg/L
Touch
to save this setting, or touch
to exit this menu without saving any
changes. The display automatically
returns to the previous screen.
10 Touch
to return to the Setup-Data
Handling menu.
77
Meter Setup
Result display mode
Test results may be displayed either with a static or a flashing display, the latter visually indicating that the measurement process has been finished. Once a result is available, the display starts
flashing. Depending on the settings, this may be either a quantitative or qualitative result screen
or an operator login screen.
09:15 am
Main Menu
Patient Test
From the Main Menu, touch Setup to
open the meter settings.
From the Setup menu, touch Data
Handling.
From the Setup-Data Handling menu,
touch Result Display Mode.
Control Test
Review Results
Setup
Setup
Basics
04/19/2015
Data Handling
ID Setup
Lockout
Optional Screens
Setup - Data Handling
Connection
04/19/2015
Result Memory
Result Units
Result Display Mode
Diagnostics
04/19/2015
78
Meter Setup
Select Res. Display Mode
Static
Flashing
From the Select Res. Display Mode menu,
select your display mode.
The current setting is highlighted (white type
on a blue background). You may select from
the following options:
■
Static
■
Flashing
Touch
to save this setting, or touch
to exit this menu without saving any
changes. The display automatically
returns to the previous screen.
Touch
to return to the Setup-Data
Handling menu.
04/19/2015
79
Meter Setup
Diagnostics
Under Diagnostics, you will find information about the system, such as software version, number
of data records stored, and configuration details. The Diagnostics menu contains functions relevant for installation, maintenance and troubleshooting purposes. In case of technical problems
the firmware version (Build) is an important information for the Roche Diagnostics customer
support.
The diagnostics screens shown here are for illustration purposes only. The Information shown on
your meter may differ.
09:15 am
Main Menu
Patient Test
From the Main Menu, touch Setup to
open the meter settings.
From the Setup menu, touch Data
Handling.
From the Setup-Data Handling menu,
touch Diagnostics.
Control Test
Review Results
Setup
Setup
Basics
04/19/2015
Data Handling
ID Setup
Lockout
Optional Screens
Setup - Data Handling
Connection
04/19/2015
Result Memory
Result Units
Result Display Mode
Diagnostics
04/19/2015
80
Meter Setup
Setup - Diagnostics
From the Setup-Diagnostics menu, touch
the button of the diagnostics screen you
want to display.
Use and to toggle between the
Wireless Setup screens.
In either diagnostics screen, touch
return to the Diagnostics menu.
Software
Wireless Setup
Software
04/19/2015
Build:
04.00.00
Boot:
06.03.00
Kernel:
06.03.00
RootFS:
06.03.00
App:
04.00.00
MM-BL:
03.00.00
MM-FW:
03.00.00
Wireless Setup
to
Note: The Wireless Setup button is only
available if the the WLAN function is enabled
on this meter.
Wireless Setup - Network
04/19/2015
Use DHCP:
Enabled
Use DNS:
Disabled
SSID:
cobas h 232
WLAN:
MAC:
01 23 45 67 89 AB
Wireless Setup
Wireless Setup - Connection
DMS Name:
POCTServer
04/19/2015
DMS Port Number:
4711
DMS IP Address:
0.0.0.0
RF Security:
WPA2-PSK (AES)
Wireless Setup
Wireless Setup - Test
04/19/2015
RF activated:
Associated:
Authenticated:
Configured IP:
192.168.0.123
IP:
Subnet: 255.255.255.0
Gateway:
DNS:
Contacted DMS:
Connected to DMS:
Completed:
Test
04/19/2015
81
Meter Setup
3.3
ID Setup setting
Use the ID Setup menu to enter settings for user management and patient management. These
settings are optional and set to Off/Inactive by default; the meter can be operated without these
settings.
There are three types of identification used with the meter:
■
System Administrator: The administrator has special rights to enter certain meter settings and is the only one who can enter and change these settings. It is not necessary for
administrator identification to be activated to use the cobas h 232 meter. However, it
might be desired or necessary, depending on the regulatory environment and the site of
use.
■
Operator: The Operator ID is assigned to persons who use the meter to run tests. If you
want to use Operator IDs, you have several options:
–
You may use Operator IDs to restrict the use of the meter to qualified personnel or a
predefined group of users. In this case an operator list created on a DMS must be transferred to the meter, enabling you to select an Operator ID when logging in. For more
details see “Data handling”, starting on page 159.
–
You may use Operator IDs for informational purposes only, in order to assign stored
measurement results to the users who performed the test. In this case Operator IDs may
directly be entered on the meter (by keypad or scanner), with or without an operator list
being available.
Patient: The Patient ID is assigned to the person, whose test results are recorded. You
can either:
■
–
block input of a unique Patient ID (in this case, every test is simply numbered in
consecutive order)
–
allow a unique Patient ID as optional, or
–
require a unique Patient ID for every test. Patient lists created on a DMS can also be transferred to the meter, enabling you to select Patient IDs for a test from these lists. For more
details see “Data handling”, starting on page 159.
Operator IDs can be selected from a list (if available) or read by the barcode scanner on the front
of the meter. If passwords were created, they must be entered via the onscreen keypad.
Patient IDs can be entered by using the onscreen keypad or the barcode scanner on the front of
the meter.
82
Meter Setup
Administrator ID
In the default setting, the meter is not protected with an Administrator ID, and all setup options
are accessible to every user. If you set up an Administrator ID, the following setup areas are automatically reserved only for the administrator (i.e., the person who knows the password):
■
Screen: Date/Time
■
Data Handling
■
ID Setup
■
Quality control and the associated lockouts
■
Optional screens
The setup of an Administrator ID does not limit or alter the usage of the meter for measurements
in any way. Furthermore setting up the Administrator ID has no impact on the usage of
Operator IDs. Only the setup options as listed above are tied to administrator access.
When you enter an Administrator ID, this ID must be entered from this point forward before
any future IDs can be set up (anywhere in the ID Setup menu). The Administrator ID must also
be entered before you can delete or change the Administrator ID.
If you forget the Administrator ID, the meter setup may be unlocked via the external data management system (e.g., cobas IT 1000). If you don’t use such a system and need to reset the
Administrator ID, contact your Roche representative (see Chapter 10).
83
Meter Setup
If an Administrator ID has not been set up
yet:
09:15 am
Main Menu
Patient Test
Control Test
Review Results
Setup
Setup
Basics
04/19/2015
Data Handling
ID Setup
Lockout
Optional Screens
Setup - ID Setup
Administrator ID
04/19/2015
Operator ID
Patient ID
04/19/2015
84
From the Main Menu, touch Setup to
open the meter settings.
From the Setup menu, touch ID Setup.
From the Setup-ID Setup menu, touch
Administrator ID.
Meter Setup
Enter Administrator ID
****|
Alphanumeric characters are any combination of A - Z and 0 - 9. Additionally “.”
(period), or “-” (hyphen) may be used.
123
Enter Administrator ID
****|
ABC
Using the onscreen keypad, enter the
Administrator ID of choice (or the password provided by Roche Diagnostics).
The ID can consist of up to 20 alphanumeric characters.
Pay close attention to the buttons you press,
because the characters are not displayed on
the screen. Asterisks are displayed instead (as
if entering a password on a computer).
Use 123 to switch to the input of
numbers.
Use
text.
Use
to backspace and correct a
mistake.
Touch
to save this Administrator ID, or
touch
to exit this menu without saving
any changes.
ABC
to switch back to the input of
85
Meter Setup
Repeat Administrator ID
****|
123
Enter the Administrator ID again (the
onscreen keypad is automatically displayed again) to confirm the first entry.
Touch
to save this entry, (the
Administrator ID is now set), or
Touch
to exit this menu, the
Administrator ID is not set and is therefore
still inactive.
The display automatically returns to the Setup-ID Setup menu. After you exit the Setup menu,
only an authenticated administrator may set up any further IDs.
86
Meter Setup
Changing an existing Administrator ID:
09:15 am
Main Menu
Patient Test
Control Test
From the Main Menu, touch Setup to
open the meter settings.
From the Setup menu, touch ID Setup.
Using the onscreen keypad, enter the
valid Administrator ID.
Review Results
The ID Setup is displayed. The Administrator ID button is highlighted, which
means an Administrator ID is active.
Setup
Setup
Basics
04/19/2015
Data Handling
ID Setup
Touch Administrator ID and use the
onscreen keypad to enter a new ID of
choice (enter it twice).
Lockout Enter Administrator ID
****|
Optional Screens
04/19/2015
123
Setup - ID Setup
Administrator ID
Operator ID
Patient ID
04/19/2015
87
Meter Setup
Disabling an existing Administrator ID:
09:15 am
Main Menu
Patient Test
Control Test
From the Main Menu, touch Setup to
open the meter settings.
From the Setup menu, touch ID Setup.
Using the onscreen keypad, enter the
valid Administrator ID.
Review Results
The ID Setup is displayed. The Administrator ID button is highlighted, which
means an Administrator ID is active.
Setup
Setup
Basics
04/19/2015
Data Handling
Touch Administrator ID.
ID Setup
Touch
to close the onscreen keypad
without entering an ID number.
Lockout Enter Administrator ID
****|
Optional Screens
04/19/2015
123
Setup - ID Setup
Administrator ID
Operator ID
Patient ID
Enter Administrator ID
04/19/2015
88
123
The Administrator ID has been deleted
and therefore deactivated. The Administrator ID button is no longer highlighted.
Meter Setup
Operator ID
In the default setting, the Operator login is not activated. You can either activate or deactivate
Operator login on the meter. If activated, an Operator has to log in before the Main Menu will be
displayed and measurements can be performed. Without a list, operators can log in directly by
entering their operator name. This setup menu allows you to select whether or not an operator
login is possible or required.
09:15 am
Main Menu
Patient Test
Control Test
From the Main Menu, touch Setup to
open the meter settings.
From the Setup menu, touch ID Setup.
From the Setup-ID Setup menu, touch
Operator ID.
Review Results
You may select from the following options:
Setup
04/19/2015
Setup
■
Off (Operator ID cannot be entered)
Basics
■
Optional (Operator ID can be entered,
but is not required)
■
Required (An Operator ID must be
entered)
■
Scan Only (An Operator ID must be
scanned)
Touch the button with the setting of
choice. Your selection is now highlighted.
Touch
to save this setting, or touch
to exit this menu without saving any
changes. The display automatically
returns to the previous screen or (depending on the option you selected) proceeds
to the next screen.
Data Handling
ID Setup
Lockout
Setup - ID Setup
Optional Screens
Administrator ID
04/19/2015
Operator ID
Patient ID
Select Operator ID
Off
Optional
04/19/2015
Required
Scan Only
04/19/2015
The entries for the option Off are now
completed. For the options Optional and
Required, continue by selecting the input
format.
89
Meter Setup
Operator ID
Alphanum.
Numeric
You may select from the following options:
■
Alphanum. (alphanumeric)
Enter any combination of A - Z and 0 - 9.
Additionally “.” (period), or “-” (hyphen)
may be used.
■
Numeric
Enter numbers only, e.g., “3387”
■
Max. Length
Enter the maximum number of characters
(1 … 20) the Operator ID can have.
Touch the button with the form of choice
for setting up the Operator ID. Your selection is now highlighted.
Touch
or
to set the number of
characters (length) of choice.
Touch
to save this setting, or touch
to exit this menu without saving any
changes.
Max. Length:
20
04/19/2015
Select the form for input of the Operator
ID.
The meter automatically returns to the
Setup-ID Setup menu.
90
Meter Setup
If you want to create a list of Operator IDs from which you can select an operator, additional
software (a data management system) and a WLAN connection or the Handheld Base Unit
are required (for more details see “Data handling”, starting on page 159).
With an Operator list being transferred to the meter, the Operator ID options are different from
the options in “standalone” mode.
09:15 am
Main Menu
Patient Test
Control Test
From the Main Menu, touch Setup to
open the meter settings.
From the Setup menu, touch ID Setup.
From the Setup-ID Setup menu, touch
Operator ID.
Review Results
You may select from the following options:
Setup
Setup
Basics
04/19/2015
■
List (Operator ID must be selected from
the list or scanned using the barcode
scanner)
■
None (Operator ID cannot be entered or
selected)
■
Hidden List (Operator ID must be
entered using the barcode scanner or the
onscreen keypad)
Touch the button with the setting of
choice. Your selection is now highlighted.
Touch
to save this setting, or touch
to exit this menu without saving any
changes. The display automatically
returns to the previous screen.
Data Handling
ID Setup
Lockout
Optional Screens
Setup - ID Setup
Administrator ID
04/19/2015
Operator ID
Patient ID
Select Operator ID
None
List
04/19/2015
Hidden List
04/19/2015
91
Meter Setup
Patient ID
Patient IDs help you to assign stored results to individual patients. In the default setting, input of
Patient IDs is set to No. This means that a consecutive number is assigned to each test. However,
you can require that a Patient ID must be entered or make it optional.
If you want to create a list of Patient IDs from which you can select a patient for testing, additional software (a data management system) and a WLAN connection or the Handheld Base
Unit are required (see page 159).
09:15 am
Main Menu
Patient Test
Control Test
From the Main Menu, touch Setup to
open the meter settings.
From the Setup menu, touch ID Setup.
From the Setup-ID Setup menu, touch
Patient ID.
Review Results
You may select from the following options:
Setup
04/19/2015
Setup
■
Off (Patient ID cannot be entered)
Basics
■
Optional (Patient ID can be entered, but
is not required)
■
Required (The operator must enter the
Patient ID)
■
Hidden List (Only available when working with a DMS. The list will not be shown.
The operator needs to enter the Patient ID
manually or via barcode scan.)
Touch the button with the setting of
choice. Your selection is now highlighted.
Touch
to save this setting, or touch
to exit this menu without saving any
changes. The display automatically
returns to the previous screen or (depending on the option you selected) proceeds
to the next screen.
Data Handling
ID Setup
Lockout
Setup - ID Setup
Optional Screens
Administrator ID
04/19/2015
Operator ID
Patient ID
Select Patient ID
Off
Optional
04/19/2015
Required
Hidden List
04/19/2015
92
The entries for the option Off are now
completed. For the options Optional and
Required, continue by selecting the input
format.
Meter Setup
Patient ID
Alphanum.
Numeric
You may select from the following options:
■
Alphanum. (alphanumeric)
Enter any combination of A - Z and 0 - 9.
Additionally “.” (period), or “-” (hyphen)
may be used.
■
Numeric
Enter numbers only, e.g., “3387”
■
Max. Length
Enter the maximum number of characters
(1 … 20) the Patient ID can have.
Touch the button with the form of choice
for the Patient ID. Your selection is now
highlighted.
Touch
or
to set the number of
characters (length) of choice.
Touch
to save this setting, or touch
to exit this menu without saving any
changes.
Max. Length:
20
04/19/2015
Select the form for input of the Patient ID
before each test.
The display automatically returns to the
Setup-ID Setup menu.
93
Meter Setup
3.4
Lockout setup
The Lockout menu contains the options for quality control tests that the operator is required to
perform at specified intervals or based on specific triggers. This is a list of the available lockout
options:
■
Operator Lockout
■
QC Settings, containing
–
–
–
–
New Lot Lockout
QC Lockout
IQC Lockout
Custom Range Trop T
■
Cleaning Lockout
■
STAT Test Config. (overriding a lockout in an emergency situation)
If the quality control test is not performed as required or if the result is outside the target value
range, the meter, parameter or test strip lot is locked from further use. Lockouts can also be set
up on an operator-specific basis, i.e., each operator must perform the corresponding quality control tests at specified intervals.
A quality control test must be completed successfully before the meter is made available again
(either to the operator or in general) for testing.
The option of setting up lockouts for operators is available only when the meter is set up for
operator logins (see page 89) and operator lists are stored in the meter.
In case of an emergency, there may not be the time to first complete the required quality control
test if a lockout has been triggered and the meter is "locked". For such cases you may set up socalled STAT Tests (STAT = Short TurnAround Time). This option allows to perform a limited
number of tests when an operator lockout or QC lockout is in force. However, once the defined
number of STAT tests has been performed, further use of the meter is no longer possible (for the
affected test parameter or operator), unless the required quality control test is successfully
completed.
STAT tests cannot be performed if IQC lockout is in place or a new lot has not (yet) passed a
quality control test (New Lot Lockout).
94
Meter Setup
Operator lockout
To perform a test with the meter, the individual steps must be performed properly. Quality control
tests can be performed on a regular basis by every operator to ensure these steps are performed
properly. By activating the operator lockout, operators are required to perform regular quality
control tests.
Main Menu
09:15 am
Patient Test
Control Test
Review Results
Setup
Setup
Basics
04/19/2015
From the Main Menu, touch Setup to
open the meter settings.
From the Setup menu, touch Lockout.
From the Setup-Lockout menu, touch
Operator Lockout.
If this button appears in gray (inactive),
the option Operator ID is deactivated.
Data Handling
ID Setup
Lockout
Optional Screens
Setup - Lockout
Operator Lockout
04/19/2015
QC Settings
Cleaning Lockout
STAT Test Config.
04/19/2015
95
Meter Setup
Select the time interval of choice in which
the required quality control tests must be
performed.
You may select from the following options:
Select Operator Lockout
■
No (deactivated)
■
Daily
■
Weekly
■
Monthly
■
Every 3 or 6 months
■
Yearly
Touch
or
to display the option of
choice on the screen. If the arrow is just an
outline
, this means no other
options are available in the direction indicated.
Touch the button to select the time interval
of choice. Your selection is now highlighted.
Touch
to save this setting, or touch
to exit this menu without saving any
changes.
No
Daily
Weekly
Monthly
Every 3 Months
04/19/2015
If you selected No, Operator Lockout is deactivated.
96
Meter Setup
Select Operator Lockout
Quality control tests may include one or
two levels. Select the number of levels
which must be performed (not applicable,
if you selected No).
Touch
to save this setting, or touch
to exit this menu without saving any
changes. The display automatically returns
to the Setup-Lockout menu.
No of Levels
One Level
Two Levels
04/19/2015
97
Meter Setup
Quality control (QC) settings
QC Settings define that operator-independent quality control tests must be run on a regular
basis. Lockouts may be triggerd by selectable time periods, and lockouts may be triggered by
certain events. The QC Settings menu contains the following options:
■
QC Lockout (time-based), with the additional option of a New Lot Lockout (applies every
time a new test strip lot is used)
■
IQC Lockout (time-based)
■
Custom Range Trop. T (customize the QC Range in accordance with applicable local
guidelines)
■
QC Result Format (select the format for QC result displays)
■
Reset Test Param. (reset all test parameters, including code chip data and QC lockouts)
98
Meter Setup
Main Menu
09:15 am
Patient Test
Control Test
Review Results
From the Main Menu, touch Setup to
open the meter settings.
From the Setup menu, touch Lockout.
From the Setup-Lockout menu, touch
QC Settings.
Setup
Setup
Basics
04/19/2015
Data Handling
ID Setup
Lockout
Optional Screens
Setup - Lockout
Operator Lockout
04/19/2015
QC Settings
Cleaning Lockout
STAT Test Config.
04/19/2015
Setup - QC Settings
QC Lockout
IQC Lockout
QC Result Format
Custom Range Trop. T
Reset Test Param.
04/19/2015
99
Meter Setup
Quality control (QC) lockout
A QC Lockout requires a quality control test to be performed. You may also set the number of
levels for this test. You may select from the following options:
■
New Lot: Yes/No (applies every time a new test strip lot is used)
The general intervals are:
■
No
■
Daily
■
Weekly
■
Monthly
All enabled QC Lockouts, if the time period has elapsed, are activated at 8:00 a.m. (default setting, time can be changed with a DMS).
See page 99 on how to access the Setup-QC Settings menu.
Setup - QC Settings
Setup - Lockout
09:15 am
Touch QC Lockout to set regularly recurring quality control tests for available test
parameters.
New Lot: Touch Yes if you want to force a
control test every time a new test strip lot
is used. Otherwise touch No.
Time intervals: Touch the button to select
the time interval of choice (e.g., Daily).
Your selection is now highlighted.
Touch
to save this setting, or touch
to exit this menu without saving any
changes.
Quality control tests may include one or
two levels. Select the number of levels
which must be performed (not applicable,
if you selected No).
Touch
to save this setting, or touch
to exit this menu without saving any
changes. The display automatically returns
to the previous screen.
New Lot:
QC Lockout
IQC Lockout
No
QC Result Format
Daily
Custom Range Trop. T
Weekly
Reset Test Param.
Monthly
04/19/2015
100
Yes
No
04/19/2015
Meter Setup
Instrument quality control (IQC) lockout
An IQC Lockout also requires a quality control test with dedicated IQC test strips to be performed. You may select from the following options:
■
No
■
Daily
■
Weekly
■
Monthly
All enabled IQC Lockouts, if the time period has elapsed, are activated at 8:00 a.m. (default setting, time can be changed with a DMS).
See page 99 on how to access the Setup-QC Settings menu.
Setup - QC Settings
Select IQC Lockout
QC Lockout
No
IQC Lockout
Daily
QC Result Format
Weekly
Custom Range Trop. T
Monthly
Reset Test Param.
04/19/2015
04/19/2015
Touch IQC Lockout to set regularly recurring instrument quality control tests (IQC
= Instrument Quality Control).
Touch the button to select the time interval
of choice. Your selection is now highlighted.
Touch
to save this setting, or touch
to exit this menu without saving any
changes. The display automatically returns
to the previous screen.
101
Meter Setup
QC result format
The QC Result format defines the kind of information that is displayed in a QC result screen. You
may select from the following options:
■
Display without a value, but with text “Pass” or “Fail”
■
Display a value
■
Display as value and with text “Pass” or “Fail”
See page 99 on how to access the Setup-QC Settings menu.
Setup - QC Settings
Select QC Result Format
QC Lockout
Pass/Fail
IQC Lockout
Value
QC Result Format
Value & Pass/Fail
Custom Range Trop. T
Reset Test Param.
04/19/2015
102
04/19/2015
Touch QC Result Format to set the display format.
Touch the button to select the result
format of choice. Your selection is now
highlighted.
Touch
to save this setting, or touch
to exit this menu without saving any
changes. The display automatically returns
to the previous screen.
Meter Setup
Custom Range Troponin T
The quality control range for Troponin T can be customized to comply with local guidelines. The
Custom Range Trop. T function enables you to narrow the default range.
■
Default Range: The meter displays the quality control range provided by Roche in the
code chip.
■
Custom Range: The option Custom Range lets the user define their own quality control
range within the default range.
See page 99 on how to access the Setup-QC Settings menu.
Setup - QC Settings
Custom Range Trop. T
QC Lockout
Touch Custom Range Trop. T to set the
quality control range.
IQC Lockout
Default Range
You may select from the following options:
QC Result Format
Custom Range
■
Default Range (Range provided in the
code chip is selected and displayed.)
■
Custom Range (The allowed percentage
deviation from target value can now be
customized).
Touch the button with the setting of
choice. Your selection is now highlighted.
■
If you selected Default Range, touch
to save this setting, or touch
to exit this
menu without saving any changes.
■
If you selected Custom Range, touch
to proceed with corresponding settings, or
touch
to exit this menu without saving
any changes The display automatically
returns to the previous screen.
Custom Range Trop. T
Reset Test Param.
04/19/2015
04/19/2015
103
Meter Setup
Custom Range Trop. T
Default Range
Custom Range Trop. T
Deviation from target
value (in %):
21
Custom Range
04/19/2015
104
04/19/2015
If you selected Custom Range, the Custom
Range screen opens and offers you the option
of customizing the deviation from target value
(percentage value).
For the control solutions, the target value
always comes from the information stored in
the code chip. If you have chosen Custom
Range, you can now select an allowed deviation from target value in the range of 0 to 50%
(in the illustration, 21%).
Use the arrows to to set the allowed percentage deviation from the target value.
■
Touch
to save this setting, or touch
to exit this menu without saving any
changes. The display automatically returns
to the previous screen.
Meter Setup
Reset test parameters
Under certain circumstances, it may be necessary to delete the test parameters stored in the
meter (for example, if a lockout exists for a test strip lot that is no longer available). However, do
not use this method for overriding lockouts in general because, after resetting the test parameters, the meter may go into a QC lockout (if configured). If the meter or a parameter is locked by
a QC lockout or an operator lockout, use STAT tests for emergency tests. STAT tests cannot be
performed if IQC lockout is in place or a new lot has not (yet) passed a quality control test (New
Lot Lockout).
See page 99 on how to access the Setup-QC Settings menu.
Reset Test Parameter
Touch Reset Test Param. to reset all
stored test parameters and QC lockouts.
IQC Lockout
Do Reset
QC Result Format
No Reset
Select Do Reset and confirm by
touching
to reset the test parameters,
or touch
to exit without resetting the
test parameters (this leads to the same
result as selecting and confirming No
Reset). The display automatically returns
to the previous screen.
Setup - QC Settings
QC Lockout
Custom Range Trop. T
Reset Test Param.
04/19/2015
04/19/2015
105
Meter Setup
Cleaning lockout
Under normal handling conditions, your meter will not be exposed to significant dirt or contamination. However, circumstances might require regular checks of the test strip guide and (when
necessary) cleaning of the meter. The Cleaning Lockout allows operators to specify time intervals
for cleaning.
Main Menu
09:15 am
Patient Test
Control Test
From the Main Menu, touch Setup to open
the meter settings.
From the Setup menu, touch Lockout.
From the Setup-Lockout menu, touch
Cleaning Lockout.
Review Results
Setup
Setup
Basics
04/19/2015
■
No
ID Setup
■
Daily
Lockout
■
Weekly
Optional Screens
■
Monthly
Touch the button to select the time interval
of choice. Your selection is now highlighted.
Touch
to save this setting, or touch
to exit this menu without saving any
changes. The display automatically returns
to the previous screen.
Setup - Lockout
Operator Lockout
You may select from the following options:
Data Handling
04/19/2015
QC Settings
Cleaning Lockout
STAT Test Config.
Select Cleaning Lockout
No
Daily
04/19/2015
Weekly
Monthly
04/19/2015
106
Meter Setup
STAT test configuration
Quality control tests ensure consistent quality and accurate measurements. In emergency situations, however, it may be necessary to perform a test without delay. To override an active lockout
for a test parameter, lot or operator, you can allow for STAT Tests (STAT = Short TurnAround
Time). STAT tests cannot be performed if IQC lockout is in place or a new lot has not (yet) passed
a quality control test (New Lot Lockout).
You can set a number of tests permitted beyond the lockout. Once the number of allowed STAT
Tests has been reached (for a single parameter), additional tests for this parameter are locked
until you successfully perform a quality control test.
STAT Tests will be counted separately for each test parameter. Thus the actual availability of
STAT Tests may differ for each parameter.
STAT tests are labelled accordingly in the result window.
107
Meter Setup
Main Menu
09:15 am
Patient Test
Control Test
From the Main Menu, touch Setup to open
the meter settings.
From the Setup menu, touch Lockout.
From the Setup-Lockout menu, touch
STAT Test Config.
Touch Enable to allow STAT Tests or:
Touch Disable to prohibit STAT Tests.
Your selection is now highlighted.
If you have enabled the option, touch
or
to set the number of additional tests.
Touch
to save this setting, or touch
to exit this menu without saving any
changes. The display automatically returns
to the previous screen.
Review Results
Setup
Setup
Basics
04/19/2015
Data Handling
ID Setup
Lockout
Optional Screens
Setup - Lockout
Operator Lockout
04/19/2015
QC Settings
Cleaning Lockout
STAT Test Config.
STAT Test
04/19/2015
Enable
Disable
Quantity:
04/19/2015
108
Meter Setup
3.5
Optional Screens setup
In this screen, you can customise display formats and test procedures. You can choose to display
additional information and select from options for managing the result display.
Main Menu
09:15 am
Patient Test
From the Main Menu, touch Setup to
open the meter settings.
From the Setup menu, touch Optional
Screens.
Control Test
In this menu screen, you may select from the
following options:
Review Results
Setup
Setup
04/19/2015
■
Display additional information on meter
status
■
Select to display results only after new
login by operator
■
Enable operators to confirm or reject test
results
Basics
Data Handling
ID Setup
Lockout
Optional Screens
Setup - Optional Screens
Start Info
04/19/2015
Result Login
Result Confirmation
04/19/2015
109
Meter Setup
The additional status information is displayed after powering on the meter or after logging off as
an operator. This includes information about current lockouts, the number of results not transferred (to the DMS) and the time since the last data transfer.
Setup - Optional Screens
Start Info Screen
Start Info
Result Login
Enable
Result Confirmation
Disable
04/19/2015
Touch Start Info.
Touch the button to select the state of the
status display. Your selection is now highlighted.
Touch
to save this setting, or touch
to exit this menu without saving any
changes.
04/19/2015
In environments with multiple operators, it can be useful to display a test only if the operator
carrying out the test is present. By requiring operators to login again before displaying results,
you ensure that only authorised persons view the results.
Setup - Optional Screens
Result Login Screen
Start Info
Result Login
Enable
Result Confirmation
Disable
04/19/2015
110
04/19/2015
Touch Result Login.
Touch the button to select the state of the
option. Your selection is now highlighted.
Touch
to save this setting, or touch
to exit this menu without saving any
changes.
Meter Setup
In some circumstances, it may be useful for operators to confirm the validity of their results. To do
so, an option can be enabled that prompts operators to confirm the results of every test.
Setup - Optional Screens
Res. Confirmation Screen
Start Info
Result Login
Enable
Result Confirmation
Disable
04/19/2015
Touch Result Confirmation.
10 Touch the button to select the state of the
option. Your selection is now highlighted.
11 Touch
to save this setting, or touch
to exit this menu without saving any
changes.
04/19/2015
111
Meter Setup
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112
Performing a Test
Performing a Test
What you need:
■
Suitable blood sampling system to collect venous whole blood
Only heparinized blood collection tubes are allowed. Refer to test strip package insert.
■
cobas h 232 meter
■
Roche CARDIAC test strips for the desired test, with the supplied code chip
■
Roche CARDIAC pipettes (or other suitable pipettes with pipetting volume of 150 μL) for
applying the sample to the test strip
The Roche CARDIAC family includes several strips. Always ensure that the disposables you
are using (e.g., test strips) are intended for use with the cobas h 232 meter. Some tests might
require a minimum software version. Ensure that the software version on the cobas h 232
meter is compatible with the test you are running (refer to the corresponding package insert
for details). Contact your Roche representative if the cobas h 232 meter requires a software
update.
Always …
■
… operate the meter according to the specified operating conditions (see page 177).
■
… follow the information on correct handling of test strips in the package insert.
■
… place the meter on a level, vibration-free surface when applying the sample to the sample
application area of the test strip. Once the sample has been completely absorbed by the
test strip, you can move the meter.
■
… keep the meter clean. See “Maintenance and Care” on page 165.
113
Performing a Test
Never …
■
… use Roche CARDIAC pipettes for collecting blood from the patient.
■
… touch or remove the test strip during a test.
■
… add more blood after the test has begun.
■
… remove or insert the code chip while the meter is performing a test.
■
… move or pick up the meter while applying the sample - wait until the necessary sample
has been absorbed completely by the test strip.
■
… store the meter at extreme temperatures.
■
… store the meter in damp or humid conditions without protection.
■
… store the meter in a dusty environment witout protection.
Accuracy/precision of measured results:
CAUTION
114
Failure to comply with the above may lead to inaccurate results. An incorrect result may lead to an error in diagnosis, therefore posing danger to
the patient.
Performing a Test
Sample material
Heparinized venous whole blood is used as sample material. For each test use exactly 150 μL
of sample.
Use a suitable sampling system to collect the blood sample. Use only heparinized blood collection tubes. Do not use blood collection tubes containing EDTA, citrate, sodium fluoride or other
additives. For details refer to the test strip package insert.
IMPORTANT NOTE: Never use Roche CARDIAC pipettes for blood sampling directly from the
vein nor for administering injections. They are not sterile-packaged and do not contain anticoagulants. Roche CARDIAC pipettes are intended only for drawing the sample from the blood
collection tube and applying it to the test strip. See page 129.
4.1
■
Observe the applicable regulations and directives for hygiene and
safety when collecting blood samples.
■
Observe the applicable regulations and directives for disposing of
potentially infectious samples and materials.
■
Dispose of used consumables in line with the disposal policy of your
hospital, institute or medical practice.
■
See safety message “Protection against infection and blood-borne
pathogens” on page 15.
Preparing to test
Prepare the required test strips (shown
here: Roche CARDIAC POC for testing
Troponin T).
Make sure that the code chip supplied
with these test strips is also at hand.
115
Performing a Test
Code chip
The code chip provides the meter with important information on the manufacturer-specific
parameters of the respective test strip lots. It contains information about the test method, the lot
number and the expiration date.
Pat. Test - Ins. Chip
Par:
■
Each test strip box contains its own code
chip. Make sure you have the code chip at
hand before performing the first test with
a new test strip lot.
■
When you insert a test strip from a new lot
for the first time, the meter prompts you to
insert the corresponding code chip. At
this point, compare the code number you
see on the display with the number that is
printed on the test strip package you are
using. If the two code numbers are identical, insert the new code chip into the slot
in the meter.
■
Once inserted, the code chip information
is read and stored on the meter. The meter
can store up to 200 code chip datasets
(100 test strip lots and 100 quality control
lots). Further tests using the same strip lot
can be performed without inserting the
code chip again.
■
The code chip is no longer required, once
the data is stored. You may leave it in the
meter, or you can use it with other meters
using the same test strip lot.
proBNP
Insert Code
Chip
04/19/2015
116
Performing a Test
Roche recommends keeping the code chip in the meter to protect the contacts from becoming
dirty. Protect the code chip from moisture and equipment which produces magnetic fields and
electrostatic discharges. Once the test strip lot is used up, dispose of the old code chip
promptly to prevent mix-ups.
Inserting the code chip
Remove the old code chip, if one is
inserted in the meter.
Always make sure that the number on the
code chip matches the number on the
label of the test strip package.
By scanning the barcode on the strip, the
meter gathers information about the
number of the required code chip.
Slide the new code chip into the slot on
the top of the meter as shown until you
feel it snaps into place.
If the code chip does not match the test strip lot, is missing or incorrectly inserted, an error
message appears in the display (see “Troubleshooting” starting on page 173).
117
Performing a Test
Test steps (overview)
The following illustration shows the steps performed during testing. The steps you actively perform are displayed with a dark background. Depending on the configuration, the individual steps
shown here may include additional actions (e.g., entering a password). Some steps may be different, working with or without Operator IDs and Patient IDs. On the following pages these steps
are explained separately for each configuration.
Without operator and patient lists (or both operator and patient ID disabled)
With operator list (or operator ID enabled)
With operator and patient list (or operator and patient ID enabled)
Powering on
Powering on
Powering on
Self-check
Self-check
Self-check
Main menu
Log in/list
Log in/list
Patient test
Main menu
Main menu
Test strip
Patient test
Patient test
Sample
Test strip
Patient ID/list
Result
Sample
Test strip
Result
Sample
Result
118
Performing a Test
Powering on the meter
Power the meter on by pressing the
button for approximately 1 second.
You can also power on the meter directly by
connecting the power adapter or by placing
the meter on the Handheld Base Unit.
The meter performs a self-check at
startup.
Self-Check
09:15 am
Self-Check
09:15 am
Performing self-checks...
SW Version: 04.00.00
04/19/2015
Self-checks complete.
SW Version: 04.00.00
04/19/2015
119
Performing a Test
Logging in
The initial steps until the Main Menu is displayed depend on the configuration and are performed
as follows:
Without operator login required
09:15 am
Main Menu
Wait until the main menu is displayed.
Enter or scan your Operator ID.
Touch
Wait until the main menu is displayed.
Patient Test
Control Test
Review Results
Setup
04/19/2015
With operator login (no operator list)
Operator ID
SC123
123
Scan
120
to confirm your entry.
Performing a Test
With operator login (list available)
Select Operator ID
09:15 am
If an operator list exists, wait until this list
is displayed.
Touch
or
to scroll through the list.
Select the operator of choice by touching
the corresponding button.
OP003
Hall, Molly-Jessica
OP001
Hughes, Adam
OP002
Patel, Alfie-Adam
Scan
04/19/2015
As an alternative (meters with a scanner), the
operator login can be performed via the builtin barcode scanner. Touch Scan and hold the
card with the barcode approx. 10-20 cm
(4-8 in) from the scanner.
It is not possible to connect an external barcode scanner to the meter.
121
Performing a Test
Password
****|
Enter the password.
Touch
to confirm your entry, or touch
to display the operator list again.
Wait until the main menu is displayed.
123
Main Menu
09:15 am
Patient Test
Control Test
Review Results
Setup
Logout
04/19/2015
122
When the tests are completed or another
operator wants to perform additional
tests, touch Logout to log out. The meter
returns to the display of the operator list.
Performing a Test
4.2
Performing a test
09:15 am
Main Menu
Check the charge level of the battery
pack. If there are no bars left in the battery
icon, you cannot perform any more tests.
Check that the date and time are correct.
Correct any incorrect settings as
described in the chapter entitled “Meter
Setup/Setting the date”.
Patient Test
Control Test
Review Results
Setup
Logout
04/19/2015
09:15 am
Main Menu
Main Menu
QC Lockout
09:15 am
Cleaning Lockout
Control Test
Review Results
Cleaning
Setup
Review Results
Logout
Clean Meter
Setup
04/19/2015
04/19/2015
Remove Cover
If a QC lockout is displayed instead of Patient
Test, you must run a quality control test
before you can perform a test (see “Control
Testing and Quality Control” starting on
page 137). If the meter is locked, a test can
only be performed as a STAT test (if this function is enabled and if there are still STAT tests
available).
If a Cleaning Lockout is displayed instead of
Patient Test, you must touch Cleaning and
follow the instructions on the screen and
clean the meter. See “Maintenance and Care”
beginning on page 165. Once you have reattached the test strip guide cover and powered the meter on again, the meter is no
longer locked.
04/19/2015
Main Menu
QC!
09:15 am
Patient Test
If the Patient Test button is available, but a
lockout is displayed, you must first perform a
quality control test for certain test parameters.
Other test parameters are not affected.
Control Test
Review Results
Setup
Logout
04/19/2015
123
Performing a Test
Without patient list
Patient ID
PID111SCHULZM457
123
Scan
Touch Patient Test.
If you selected the Patient ID as optional,
you can enter or scan a Patient ID.
If you selected the Patient ID as required,
you must enter or scan the Patient ID.
If you selected no Patient ID (None), the
meter automatically proceeds to the next
step.
Touch
to confirm the ID, or touch
to cancel the ID entry.
Continue reading on page 127.
124
Performing a Test
With patient list
Touch Patient Test.
Patient lists can only be created on a DMS
and must be transferred to the meter. Lists
cannot be created on the meter.
Select Patient ID
Touch
or
to scroll through the list.
Select the patient to be tested by touching
the corresponding button.
If the patient is not in the list, touch New
to create a new entry. You must now enter
a Patient ID manually or scan it using the
barcode scanner.
PID001GERTA123
Anders, Gert
PID001BERNDH123
Bernd, Hans
PID001CHAPLINC123
Chaplin, Charlene
PID001FRENZENA12
Frenzen, Alice
Patient ID
PID111SCHULZM457
PID230ONEALJ1234
ONeal, John
New
04/19/2015
123
Scan
Scan
125
Performing a Test
Select Patient ID
PID001GERTA123
Anders, Gert
PID001BERNDH123
Bernd, Hans
PID001CHAPLINC123
Chaplin, Charlene
PID001FRENZENA12
Frenzen, Alice
PID230ONEALJ1234
ONeal, John
New
04/19/2015
126
Scan
The Patient ID can also be entered via barcode (meters with a barcode scanner only).
Touch Scan and hold either
■
a card with the barcode approx. 10 cm
from the scanner or
■
the meter over a patient bracelet.
The scanner is also active, once you open the
Enter Patient ID screen using the New button
(for approx. 10 seconds).
Performing a Test
Inserting a test strip
Pat. Test - Ins. Strip
Pat:
Op:
The test strip icon prompts you to insert a
test strip. Remove the test strip from its
foil pouch.
Hold the test strip so that the application
area and test area are facing up.
Hold the test strip straight and flat. Insert
it in the test strip guide of the meter. Be
careful that the strip is not shifted, angled
or tilt during insertion. It is also important
that you insert the test strip using one
smooth movement.
PID111SCHULZM457
SCHULZ, MANFRED
JONES, TOM
Insert Strip
04/19/2015
Inserting the test strip too slowly or too fast
can cause a barcode reading error.
Slide the test strip in as far as it will go. A beep
tone indicates that the meter has detected the
test strip (provided the beeper is enabled).
Exposure to external influences (e.g., humidity) may deteriorate the test strips and may lead to
error messages! Remove the test strip from its foil pouch only when you are ready to perform
a test.
127
Performing a Test
Pat. Test - Ins. Chip
Par:
proBNP
If you use a new test strip lot, you must insert
the corresponding code chip once.
See “Code chip” on page 116.
Depending on the meter setting, you may also
be required to run a quality control test at this
point.
Insert Code
Chip
The meter identifies the required code chip
based on the test strip barcode and displays
the code number.
04/19/2015
For each test parameter and each new test strip lot a different code key number is displayed.
Pat. Test - Warming Up
Pat:
Op:
Par:
PID111SCHULZM457
SCHULZ, MANFRED
JONES, TOM
proBNP
Code: PB1234
The thermometer icon shows that the test
strip is warming up. A beep tone indicates
when the warming-up process is complete
(provided the beeper is enabled).
Please Wait
Warming Up
04/19/2015
Pat. Test - App. Sample
Pat:
Op:
Par:
PID111SCHULZM457
SCHULZ, MANFRED
JONES, TOM
proBNP
Code: PB1234
150 µL
Apply
Sample
4:10 Min
04/19/2015
The pipette icon indicates that the meter is
ready to perform the test and is waiting for
blood to be applied.
Simultaneously, a 5-minute countdown
begins. You must apply the sample within this
time. Otherwise you will receive an error
message (after the sample detection has
timed out). The test strip is now unusable,
repeat the test with a new test strip.
In case of errors, see “Troubleshooting” on
page 173.
128
Performing a Test
Using the Roche CARDIAC pipette, draw
exactly 150 μL (to the blue mark on the
pipette) heparinized blood from the blood
collection tube. Make sure the sample
contains no air bubbles.
Apply the entire sample to the sample
application area of the test strip.
150 µL
Always place the meter on a level, vibrationfree surface when applying the sample to the
sample application area of the test strip. Once
the sample has been completely absorbed by
the test strip, you can move the meter.
Touch
to confirm that the sample has
been applied.
The hourglass icon appears as the meter
begins to process the sample. For better
control over the measurement process, you
should always confirm this yourself, instead of
waiting for the meter to detect the sample.
After you confirm that the sample has been
applied, or if the meter automatically recognises that the sample has been applied, the
button disappears.
129
Performing a Test
Pat. Test - Measuring
Pat:
SCHULZ, MANFRED
Op:
Par:
JONES, TOM
proBNP
Code: PB1234
10:20 Min
The hourglass icon spins until the sample has
been detected and the test begins. The time
remaining for the test is displayed.
Measurement time:
The time needed to run a test depends on the
test parameter (refer to package insert for
details). Typically, 8 to 12 minutes are
required.
04/19/2015
Do not add more blood. Do not touch the test strip until the result is displayed.
Pat. Test - Measuring
Pat:
SCHULZ, MANFRED
Op:
Par:
JONES, TOM
Trop T
Code: TT 2721
10:20 Min
TnT Elevated
04/19/2015
130
For Troponin T only:
As soon as the meter detects a signal (this
may take a few minutes), a qualitative result
(TnT Elevated) appears under the hourglass
icon (see illustration).
The quantitative result is displayed when the
test is completed. Refer to the Roche
CARDIAC T Quantitative or Roche CARDIAC
POC package insert for more details.
Performing a Test
Pat. Test - Result
Pat:
Op:
Par:
PID111SCHULZM457
SCHULZ, MANFRED
JONES, TOM
Code: PB1234
proBNP
01/25/2015 10:17
620 pg/ml
The test result is shown and stored automatically.
When interpreting your result, please read the
test strip package insert carefully.
04/19/2015
Print button:
Print results (infrared interface)
QR Code button:
Display result as QR code
Menu button:
Return to main menu
Comment button:
Add predefined or custom comments to the
test result
Remove the test strip from the meter.
Power the meter off by pressing the
button for approximately 1 second if you
do not wish to perform any further tests.
Discard the used disposable item and test
strip in compliance with the disposal policy
of your hospital or medical practice.
10 Clean the meter if necessary. See “Maintenance and Care” on page 165).
131
Performing a Test
Displaying, confirming or adding comments to results
As described in the chapter “Optional Screens setup” starting on page 109, there are many
options for displaying results that can be activated:
If a new Operator Login is required to display
the result:
Pat. Test - Op. Login
Pat:
Op:
Par:
PID111SCHULZM457
SCHULZ, MANFRED
JONES, TOM
Code: PB1234
proBNP
Touch the button for Operator Login.
Log in as described on page 121.
Measurement Complete
04/19/2015
The result is now displayed.
132
Performing a Test
Pat. Test - Confirm.
Pat:
Op:
Par:
PID111SCHULZM457
SCHULZ, MANFRED
JONES, TOM
Code: PB1234
proBNP
If the test result requires a confirmation:
■
01/25/2015 10:17
620 pg/ml
Measurement OK?
Reject
Accept
04/19/2015
Pat. Test - Result
Pat:
Op:
Par:
PID111SCHULZM457
SCHULZ, MANFRED
JONES, TOM
Code: PB1234
proBNP
When the result is displayed, touch the
button to select the confirmation of
choice.
You can choose to either
■
Reject
■
Accept
If you reject the result, the result value is no
longer displayed. However, the test entry is
stored.
01/25/2015 10:17
Rejected
04/19/2015
133
Performing a Test
You can add up to three comments to a test result. Comments can provide, for example, additional information about the test conditions or the patient. A comment may be up to 20 characters in length. You can open the function for adding comments directly in the results screen.
If you want to add a comment, do not remove the test strip. Once the strip is removed, the
meter automatically returns to Main Menu and a comment can no longer be added.
If you want to add a comment to a test result:
Pat. Test - Result
Pat:
Op:
Par:
PID111SCHULZM457
SCHULZ, MANFRED
JONES, TOM
Code: PB1234
proBNP
Pat. Test - Comment
01/25/2015 10:17
Symptomatic
In the result screen, touch
Select a predefined comment from the list
and/or
Touch Custom to enter your own comment using the onscreen keypad.
620 pg/ml
Asymptomatic
Chest Pain
Dyspnea
04/19/2015
Custom
The comments are stored with the test result.
04/19/2015
Pat. Test - Result
Pat:
TESTER
Op:
Par:
User1
Trop T
Code: TT 2721
01/25/2015 10:17
620 pg/ml
Symptomatic
Chest Pain
Test
04/19/2015
134
Performing a Test
Displaying the test result as QR code
The QR code button only appears if the QR code display function is activated (see
page 65 and following). Otherwise it is not displayed.
Touch
code.
to display the result as QR
Touch
to return to the standard
result display.
The size of the QR code displayed on the
screen varies according to the amount of data
encoded.
135
Performing a Test
STAT tests
STAT tests are a limited number of tests that can be performed in emergency situations, see
page 107. If the meter is configured to perform STAT tests, you have the option of performing a
test by choosing STAT even though a QC Lockout is in place.
Pat. Test - Lockout
Pat:
Op:
Par:
To perform the measurement without
performing a quality control test, touch
STAT, or:
Touch
to perform the quality control
test before the measurement.
PID111SCHULZM457
SCHULZ, MANFRED
JONES, TOM
proBNP
Code: PB1234
Test Parameter Locked!
Please Perform QC.
STAT
04/19/2015
Pat. Test - Result
Pat:
Op:
Par:
PID111SCHULZM457
SCHULZ, MANFRED
JONES, TOM
Code: PB1234
proBNP
01/25/2015 10:17
620 pg/ml
STAT Test
04/19/2015
136
When a STAT test is performed, this information is stored with the result. The
number of permissible STAT tests is
reduced by 1. After all pending quality
control tests are performed, the specified
number of STAT tests is available again in
case of a new lockout.
Control Testing and Quality Control
Control Testing and Quality Control
The cobas h 232 POC system employs several methods to check that the meter and test strips
are working properly and that the operator is performing the test correctly.
The meter has a number of built-in quality control functions:
■
A self-check of the electronic components and functions every time the meter is powered
on.
■
A check of test temperature when warming up and during the test.
■
A check of the expiration date and lot information on the test strip using the information
from the code chip.
In addition, the cobas h 232 POC system provides:
■
Configurable, prescribed quality control tests using Roche CARDIAC IQC test strips for
internal functionality tests.
■
Definable, prescribed control tests using Roche CARDIAC Control materials for the available test parameters.
5.1
Preparing to run a quality control test
Prepare for a quality control test in the same way you would prepare to perform a test with a
patient sample. The only difference is the use of control solution instead of blood.
To perform a quality control test using control solutions, you need:
■
cobas h 232 meter
■
Test strips for the desired tests, with the supplied code chip
■
Roche CARDIAC pipettes (or other suitable pipettes with pipetting volume of 150 μL)
■
Control set containing two vials of Roche CARDIAC Control material and code chip
137
Control Testing and Quality Control
Always refer to the package insert provided with the control material for
specific handling and testing instructions.
Reconstituted control material taken from the refrigerator must be allowed to reach room
temperature before use.
You can specify the frequency of quality control tests according to your own requirements (see
“Meter Setup/Lockout setup” starting on page 94).
If you encounter a lockout for a test strip lot that no longer exists, see “Reset test parameters” on
page 105. Please note that, when you use this method, all saved test parameters and QC lockouts will be deleted.
138
Control Testing and Quality Control
5.2
Performing a quality control test
Quality control (QC)
Power the meter on by pressing the
button for approximately 1 second.
You can also power on the meter directly by
connecting the power adapter or by placing
the meter on the Handheld Base Unit.
Depending on the system settings the operator my have to log in and/or enter a password.
Follow the procedures as described on
page 121.
Main Menu
QC!
09:15 am
Wait until the main menu is displayed.
Patient Test
Control Test
Review Results
Setup
04/19/2015
139
Control Testing and Quality Control
Main Menu
QC!
09:15 am
Touch Control Test.
In the QC Status screen, touch
to continue with the quality control test.
The test strip icon now prompts you to
insert a test strip. Remove the test strip
from its foil pouch.
Hold the test strip so that the application
area and test area are facing up.
Hold the test strip straight and flat. Insert
it in the test strip guide of the meter. Be
careful that the strip is not shifted, angled
or tilt during insertion. It is also important
that you insert the test strip using one
smooth movement.
Patient Test
QC Test - QC Status
Control Test
Review Results
Setup
QC Status
CK-MB
DDimer
Myo
- Pass
- Pass
- Pass
proBNP
Trop T
- Locked
- Locked
04/19/2015
QC Test - Ins. Strip
04/19/2015
Op:
JONES, TOM
Insert Strip
Inserting the test strip too slowly or too fast
can cause a barcode reading error.
04/19/2015
Slide the test strip in as far as it will go. A beep
tone indicates that the meter has detected the
test strip (provided the beeper is enabled).
Exposure to external influences (e.g., humidity) may deteriorate the test strips and may lead to
error messages! Remove the test strip from its foil pouch only when you are ready to perform
a test.
140
Control Testing and Quality Control
If you use a new test strip lot and have not
inserted the code chip yet, you must do so
now. Otherwise you cannot perform a quality
control test.
QC Test - Sel. QC Lot
Par:
pro BNP
Op:
JONES,TOM
Code: PB1234
Code PBC014
Code PBC016
Code PBC017
Code PBC018
New
As with the test strips, a code chip is also provided with the control materials. The information on the code chip is stored in the memory
so you can use the same control materials
again at any time.
Select the code stored for your current
control material, or touch New to use a
new control material.
04/19/2015
QC Test - Ins. Chip
Par:
QC:
Op:
Code: PB1234
proBNP
PBC014
JONES, TOM
If you are using a new control material,
remove the code chip from the meter and
insert the code chip that came with the
control material instead.
QC
Insert Code
Chip
PBC014
04/19/2015
141
Control Testing and Quality Control
QC Test - Sel. QC Level
Par:
QC:
Op:
Code: PB1234
proBNP
PBC014
JONES, TOM
If the control material box contains more
than one level, select the level of choice
for this measurement.
Level 1
Level 2
04/19/2015
QC Test - Warming Up
Par:
QC:
Op:
Code: PB1234
proBNP,
PBC014
Level: 1
JONES, TOM
The thermometer icon shows that the test
strip is warming up. A beep tone indicates
when the warming-up process is complete
(provided the beeper is enabled).
Please Wait
Warming Up
04/19/2015
QC Test - App. QC
Par:
QC:
Op:
Code: PB1234
proBNP
PBC014
Level: 1
JONES, TOM
150 µL
Apply QC
4:10 Min
04/19/2015
142
The pipette icon indicates that the meter is
ready to perform the test and is waiting for the
sample to be applied.
Simultaneously, a 5-minute countdown
begins. You must apply the sample within this
time, otherwise you will receive an error
message (after the sample detection has
timed out).
In case of errors, see “Troubleshooting” on
page 173.
Control Testing and Quality Control
10 Using the pipette, draw up the dissolved
contents of the vial.
11 Apply the sample (exactly 150 μL) to the
application area of the test strip.
Always place the meter on a level, vibrationfree surface when applying the sample to the
sample application area of the test strip. Once
the sample has been completely absorbed by
the test strip, you can move the meter.
12 Touch
to confirm that the sample has
been applied.
The hourglass icon appears as the meter
begins to process the sample. For better
control over the measurement process, you
should always confirm this yourself, instead
of waiting for the meter to detect the sample.
13 After you confirm that the sample has
been applied, or if the meter automatically
recognises that the sample has been
applied, the
button disappears.
QC Test - Processing
Par:
QC:
Op:
Code: PB1234
proBNP
PBC014
Level: 1
JONES, TOM
The hourglass icon spins until the sample has
been detected and the test begins.
Unlike regular tests, this procedure can be
very short and therefore might not be displayed (especially in case of a lack of or delay
in confirmation, see step 12).
Processing...
04/19/2015
143
Control Testing and Quality Control
The time remaining for the test is displayed.
QC Test - Measuring
Par:
QC:
Op:
Code: PB1234
proBNP
PBC014
Level: 1
JONES, TOM
Measurement time:
The time needed to run a test depends on the
test parameter (refer to package insert for
details). Typically, 8 to 12 minutes are
required.
10:20 Min
04/19/2015
QC Test - Result
Par:
QC:
Op:
Code: PB1234
proBNP
PBC014
Level: 1
JONES, TOM
01/25/2015 10:17
Pass:
329 pg/ml
(350 / 300-400 pg/ml)
04/19/2015
QC Test - Result
Par:
QC:
Op:
Code: PB1234
proBNP
PBC014
Level: 1
JONES, TOM
01/25/2015 10:17
Fail:
490 pg/ml
(350 / 300-400 pg/ml)
04/19/2015
The result of this quality control test is displayed and is automatically saved to memory.
The target value and the range in which the
results for this control material should be
located is displayed below the current result.
If a quality control test fails, an up arrow (too
high) or down arrow (too low) is displayed.
There are three options for displaying a QC
test result:
• Pass/Fail
• Value
• Value & Pass/Fail
For details refer to “QC result format” on
page 102 and “Settings summary” on
page 47.
144
Control Testing and Quality Control
Print button:
Print results (infrared interface)
QR Code button:
Display result as QR code
Menu button:
Return to main menu
Comment button:
Add predefined or custom comments to the
test result
14 Remove the test strip from the meter.
15 Power the meter off by pressing the
button for approximately 1 second if you
do not wish to perform any further tests.
16 Discard the used disposable item and test
strip in compliance with the disposal policy
of your hospital or medical practice.
17 Clean the meter if necessary (see “Maintenance and Care” on page 165).
145
Control Testing and Quality Control
Displaying the QC result as QR code
The QR code button only appears if the QR code display function is activated (see
page 65 and following). Otherwise it is not displayed.
Touch
code.
to display the result as QR
Touch
to return to the standard
result display.
The size of the QR code displayed on the
screen varies according to the amount of data
encoded.
146
Control Testing and Quality Control
Instrument quality control (IQC)
The Roche CARDIAC IQC test serves as a performance check for the optical system of the
cobas h 232 POC system. The instrument determines the reflectance value of the signal and
displays “Pass”, “Fail” or the percentage of remission depending on your settings.
“Pass” means that the optical system of the cobas h 232 POC system is functioning properly. If
“Fail” appears, the measured reflectance value is outside the confidence interval.
Prepare the required IQC test strips
(shown here: Roche CARDIAC IQC high).
Make sure that the code chip supplied
with these test strips is also at hand.
147
Control Testing and Quality Control
The first steps in this quality control test are identical to the procedure described before, see
page 139. The following description therefore starts at the main menu.
Main Menu
QC!
09:15 am
Patient Test
Touch
in the QC Status screen to continue with quality control test. The test
strip icon prompts you now to insert a test
strip.
Remove the test strip from its IQC test
strip container.
Insert the test strip as described before,
see page 140.
If you are using a new lot of IQC test strips
and have not inserted the code chip yet,
you must do so now. If you have used the
test strips already, skip this step.
QC Status
Review Results
Setup
04/19/2015
CK-MB
DDimer
Myo
- Pass
- Pass
- Pass
proBNP
Trop T
- Locked
- Locked
QC Test - Ins. Strip
JONES, TOM
04/19/2015
Insert Strip
QC Test - Ins. Chip
Par:
IQC
Op:
JONES, TOM
04/19/2015
QC
Insert Code
Chip
702
04/19/2015
148
Touch Control Test.
QC Test - QC Status
Control Test
Op:
Control Testing and Quality Control
QC Test - Measuring
Par:
IQC
Op:
JONES, TOM
Code:
Level:
IQC702
The hourglass icon is displayed and the (internal) measurement begins.
04/19/2015
QC Test - Result
Par:
IQC
Op:
JONES, TOM
Code:
Level:
11/04/2015
IQC702
10:17
83 %
(85 / 82 - 88 %)
The result of this IQC quality control test is
displayed as Pass or Fail (default setting) or in
the format selected in the QC result format
setting.
There are three options for displaying an IQC
test result:
• Pass/Fail
04/19/2015
• Value
• Value & Pass/Fail
For details refer to “QC result format” on
page 102 and “Settings summary” on page 47.
149
Control Testing and Quality Control
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150
Review Results
Review Results
The cobas h 232 meter can save 2000 patient test results as well as 500 quality control tests to
memory, together with time, date, lot number and, if applicable, IDs and comments.
Reviewing test results
Power the meter on by pressing the
button for approximately 1 second.
You can also power on the meter directly by
connecting the power adapter or by placing
the meter on the Handheld Base Unit.
Depending on the system settings the operator my have to log in and/or enter a password.
Follow the procedures as described on
page 121.
Main Menu
09:15 am
Wait until the main menu is displayed.
Patient Test
Control Test
Review Results
Setup
04/19/2015
151
Review Results
From the Main Menu you have access to all stored results, sorted by selectable criteria:
■
Patient History
■
All Results
■
QC Results (Quality Control)
■
IQC Results (Instrument Quality Control)
■
Maintenance History
Main Menu
09:15 am
Review Results
Patient History
Patient Test
All Results
Control Test
QC Results
Review Results
IQC Results
Setup
Mainten. History
04/19/2015
Touch Review Results.
Select the function you want to perform in
the memory.
04/19/2015
The print button only appears if the printer function is activated. Otherwise it is not displayed.
The QR code button only appears if the QR code display function is activated. Otherwise
it is not displayed.
152
Review Results
Patient history
This memory area contains a list of all patients, sorted by Patient ID. From here, you can call up
results for any individual patient.
Pat. History - Select ID
Touch
or
to display the entry of
choice on the screen. If the arrow is just
an outline
, you have reached the
beginning or end of the patient list.
Touch the patient name whose results you
want to open.
Touch
or
to display the test result
of choice on the screen.
Touch the test result you would like to
view in detail.
PID001GERTA123
Anders, Gert
PID001BERNDH123
Bernd, Hans
PID001CHAPLINC123
Chaplin, Charlene
PID001FRENZENA12
Frenzen, Alice
PID230ONEALJ1234
ONeal, John
Scan
04/19/2015
Single Patient Results
Pat:
PID111SCHULZM457
SCHULZ, MANFRED
DDimer
02/12/15
High
08:30
proBNP
620 pg/ml
02/08/15
09:49
DDimer
01/21/15
1.3 µg/ml
09:15
Pat. Test - Result
Pat:
Op:
Par:
PID111SCHULZM457
SCHULZ, MANFRED
JONES, TOM
Code: PB1234
proBNP
02/08/2015 09:49
620
pg/ml
New Strip Lot
04/19/2015
04/19/2015
153
Review Results
All results
This memory area contains a list of all tests, sorted chronologically. From here, you can call up
results for specific times.
All Results
Touch
or
to display the entry of
choice on the screen.
Touch the patient name whose result you
want to open.
Doe, John
02/15 10:52 Trop-T
Smith, Adam
02/15 10:11 proBNP
Zend, Nora
02/15 09:40 DDimer
Smith, Bob
02/14 11:40 Trop-T
Smithee, Aaron
02/14 10:50 proBNP
04/19/2015
Pat. Test - Result
Pat:
Op:
Par:
PID111SCHULZM457
SCHULZ, MANFRED
JONES, TOM
Code: PB1234
proBNP
02/08/2015 09:49
620
pg/ml
New Strip Lot
04/19/2015
154
The selected test result dialog box will appear.
When you touch
, a list of results for the
selected patient is displayed (see page 153).
Review Results
Quality control (QC) results
This memory area contains all test parameter-specific quality control tests (QC, starting on
page 139) that were run, sorted chronologically. The most recent results are at the top of the list.
QC Results
DDimer
02/12/15
L2
08:30
DDimer
02/12/15
L1
08:00
proBNP
02/04/15
L1
10:17
DDimer
01/10/15
L2
07:30
DDimer
01/10/15
High
07:05
Touch
or
to display the entry of
choice on the screen.
Touch the entry you want to open.
04/19/2015
QC Result
Par:
QC:
Op:
Code: PB1234
proBNP
PBC014
Level: 1
JONES, TOM
The entry is displayed.
04/18/2015 10:17
Pass: 329 pg/ml
(350 / 300-400 pg/ml)
04/19/2015
155
Review Results
Instrument quality control (IQC) results
This memory area contains all instrument quality control tests (IQC, starting on page 147) that
were run, sorted chronologically. The most recent results are at the top of the list.
IQC Results
IQC
04/11/15
Pass
07:59
IQC
04/07/15
Pass
08:16
IQC
04/07/15
Fail
08:01
IQC
03/29/15
Pass
08:30
IQC
03/29/15
Pass
09:02
Touch
or
to display the entry of
choice on the screen.
Touch the entry you want to open.
04/19/2015
QC Test - Result
Par:
IQC
Op:
JONES, TOM
Code:
Level:
02/08/2015
IQC702
10:17
83 %
(85 / 82 - 88 %)
04/19/2015
156
The entry is displayed.
Review Results
Maintenance history
Maintenance History actually is a list of comments. Whenever routine maintenance or service is
done for the meter, this event can be stored in form of a comment. You may use the default
preset comments in the meter or enter a custom comment.
Maintenance History
Meter Cleaned
04/13/2015 08:00
Meter Cleaned
04/05/2015 08:20
Meter Cleaned
03/29/2015 09:00
New Battery Pack
03/21/2015 08:30
Touch
or
to display the entry of
choice on the screen.
Once saved, a maintenance comment can not
be opened or edited. Maintenance History is
(like test results) a view-only list. You can,
however, add new entries:
Meter Cleaned
03/14/2015 08:10
New
04/19/2015
Touch New.
Touch
or
to display the predefined
comment of choice on the screen.
Touch the predefined comment you
would like to add to the Maintenance History or:
Touch Custom to enter your own text
using the onscreen keypad.
Touch
to save your comment.
157
Review Results
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158
Extended Functionalities
Extended Functionalities
Data handling
Extended data handling functionality is dependent on the capabilities of the particular Data
Management System (DMS) being used and may vary.
When used in conjunction either with WLAN (if the meter is equipped with WLAN) or with the
(optional) Handheld Base Unit from Roche Diagnostics, the cobas h 232 meter can conveniently
connect to a data management system (DMS). The main advantages of such a connection
between meter and DMS may include:
■
Transferring patient lists, operator lists, and settings from the DMS to the meter. In this
way the setup for daily work as well as general meter setup can be performed (for one or
more meters) quickly and conveniently.
■
Transferring all stored test results with the corresponding Patient ID, Operator ID, and
comments from the meter to the DMS. This transfer of data permits further evaluation or
proper archiving according to your needs.
Through the DMS the system administrator (such as the POC coordinator) may specify what settings are to be applied to a set of meters within a site or unit (e.g., hospitals or wards). All meters
assigned to a specific site and/or unit would consequently share the same settings. The different
operator and patient lists (that match a site or unit) are then made available on their respective
meters. Other settings such as QC Lockout and Operator Lockout may easily be set (once) and
distributed to all meters.
The option of setting up an Operator Lockout is available only when operator lists are created
on the DMS, stored in the meter, and Operator login is activated. For more details on Operator
login see page 89, for details on Operator Lockout see page 95.
159
Extended Functionalities
Computer (Setup option)
For initial connection to a DMS, the ability to communicate within a network has to be set up as
follows:
■
In the Setup menu, the Connection option must be set to Computer (see page 68).
■
The Handheld Base Unit must be configured correctly. (For details please refer to the
manual of the Handheld Base Unit and the Technical Note stored on the Handheld Base
Unit itself.)
■
Place the meter on a Handheld Base Unit that is connected to the network. The meter will
automatically be recognized by the DMS and may now be assigned to a site and/or unit
managed by the DMS (if your DMS has that functionality).
■
Depending on DMS functionality available, the DMS may transfer settings and lists to the
meter as well as enable test results to be transferred from the meter to the DMS.
160
Extended Functionalities
Operator lists
After powering the meter on, an Operator login may be configured. If no list is available, the
options described on page 89 apply.
■
Operator is set to Optional or Required:
The Operator can either log in via the onscreen keypad or a barcode scan. The use of the
meter is not restricted to a predefined Operator group, so Operator IDs are entered via the
onscreen keypad or read from the barcode and stored with test results for informational
purposes only.
■
Operator is is set to Scan Only:
The display of the meter's onscreen keypad is blocked. The Operator can only log in via
a barcode scan as there is no onscreen keypad. The use of the meter is not restricted to
a predefined Operator group, so Operator IDs are read from the barcode and stored with
test results for informational purposes only.
Meters which are managed by a DMS may receive an Operator list.
■
Operator ID is set to List, a list is available and displayed on the login screen:
The Operator selects the ID from the displayed list. If so configured by the Administrator,
the Operator may also be required to enter a password to log in.
■
Operator ID is set to Hidden List:
The Operator can login via a barcode scan or the onscreen keypad. If so configured by
the Administrator, the Operator may also be required to enter a password to log in.
When working with operator lists: The use of the meter is restricted to the operators on this
list.
161
Extended Functionalities
Patient lists
When starting a Patient Test, there will be the option of either selecting a Patient ID from a
patient list, entering the Patient ID using the onscreen keypad or, if available, of scanning the
barcode with the Patient ID. The Patient ID, if entered on the DMS, comes with an additional
identification entry. Up to 20 characters can be used and assigned as a second confirmation
(e.g., name, date of birth).
There are four possible configurations for a Patient ID input:
■
The Patient ID is set to Optional or Required, and there is no list available:
A Patient ID can be entered manually via the onscreen keypad or read in via a barcode
scan. The Patient ID is stored with the test result.
■
The Patient ID is set to No, but there is a list available:
The list of Patient IDs is always shown when starting a test. You may now
–
–
–
select a patient from the list;
scan a Patient ID using the barcode scanner;
create a new patient entry by touching New. Instead of an ID a consecutive number will
be assigned to this result.
The Patient ID is set to Optional or Required, and there is a list available:
The list of Patient IDs is always shown when starting a measurement. You may now
■
–
–
–
select a patient from the list;
scan a Patient ID using the barcode scanner;
create a new patient entry by touching New. You may either read the ID using the barcode scanner or enter a new ID via the onscreen keypad.
The Patient ID is set to Hidden List (only possible with a data management system), and
there is a list available:
An empty list is shown when starting a measurement. You may now
■
–
–
scan a Patient ID using the barcode scanner;
create a new patient entry by touching New. You may either read the ID using the barcode scanner or enter a new ID via the onscreen keypad.
When working with Patient lists, you have the following options:
■
A Patient ID does not have to be on the list to be scanned and used.
■
The meter displays a warning that the Patient ID scanned is not on the list.
■
The meter displays an error message that the ID was not found on the list of valid Patient
IDs. You must enter a valid ID to proceed.
162
Extended Functionalities
Barcode scanner
Using a DMS, the barcode scanner may be configured to accept only selected barcode symbologies. Furthermore, it is possible to define a barcode mask for Patient ID and Operator ID. With
masks being defined, the meter checks a barcode after scanning and rejects it, if it does not
match the mask. See “Example of barcode symbologies” on page 183 for further information.
Stored test results and comments
When performing a test, the test result will be stored along with additional information, including
the Patient ID, Operator ID, the kind of test performed, and optional Comments. The meter comes
with a default set of Comments that can be assigned to each test result. If you are working with
a DMS, these comments can be replaced by the comments in the DMS. The new wording will
then be available for selection from the Comments list in the meter.
Up to 3 comments can be assigned to each result.
The Comment function may be configured to be either optional, required for test results which
are out of range, or always required. If the user is required to enter/select a comment, completely empty comments will not be accepted by the meter.
163
Extended Functionalities
The default preset comments in the meter are:
Patient and QC Result comments
Maintenance comments
■
Symptomatic
■
Meter Cleaned
■
Asymptomatic
■
■
Chest Pain
Samp. App. Area Cl. (Sample Application
Area Cleaned)
■
Dyspnea
■
■
Intermediate Zone
Test Strip Guide Cl. (Test Strip Guide
Cleaned)
■
Doctor Notified
■
New Battery Pack
■
RN Notified
■
Under Medication
■
Will Repeat Test
■
No Action
■
New Strip Lot
■
New Strip/Kit Lot
■
New Lot Number
■
Lab Draw
■
Cleaned Meter
■
Switched QC Vial
■
Repeat Control Test
■
Acceptable Control
■
New Control Lot
■
Procedure Error
164
Maintenance and Care
Maintenance and Care
8.1
Conditions for storage and shipping
Storage
■
Store the system and test strips in the same environment in which they are used.
■
Do not store the meter in direct sunlight or under extreme temperature conditions.
■
Observe the limits for temperature and humidity when storing and using the meter (see
Chapter 10).
165
Maintenance and Care
Shipping
Observe the following safety information when shipping the meter and
battery pack. Failure to do so may result in injury to persons or damage
to the meter or battery pack.
■
If the meter is shipped or transported over long distances, always remove the battery pack
from the meter. This eliminates the possibility of the battery pack overheating due to a
short-circuit in the meter. It also prevents deep discharge and other damage to the battery pack or meter.
■
Only ship undamaged battery packs. Damaged battery packs must be disposed of locally.
See page 18 for the risks associated with damaged battery packs and disposal information.
■
Package the battery pack for shipping so that it cannot move around in the packaging.
Also observe any other applicable national regulations.
■
When shipping via third parties (e.g., by air or parcel service), work with the carrier to
check whether specific requirements need to be met in relation to the lithium-ion battery
packs on the basis of national or international laws on hazardous goods and, where applicable, if special packaging and labeling requirements apply.
For short distances - example between a facility’s sites - users may transport the battery packs
(either installed in the meter or separately) by road without having to meet further requirements.
166
Maintenance and Care
8.2
Cleaning and disinfecting the meter
Difference between cleaning and disinfecting
Cleaning is the physical removal of organic soiling (e.g., dirt, or other foreign material) from the
meter surface.
Disinfecting is the removal of most, but not all, disease-causing and other types of microorganisms (blood-borne pathogens) from the meter.
When should the meter be cleaned and disinfected?
■
Clean the meter to remove visible soil and organic material for safe handling and/or prior
to disinfecting.
■
You can use the Cleaning Lockout function (see page 106) to ensure regular checks are
performed.
What to clean and disinfect?
The following parts of the meter may be cleaned/disinfected:
■
The visible area of the test strip guide
■
The test strip guide cover
■
The meter display (touchscreen)
■
The meter housing (entire meter surface - front and back)
NOTICE
■
Observe the disinfection guidelines of your institution.
■
Use gloves.
Follow the procedures below to clean/disinfect the meter. Failure to
follow these procedures may cause malfunction of the meter.
167
Maintenance and Care
NOTICE
Instrument damage due to moisture
Ensure that no liquid enters the meter. If moisture enters the meter, it may
cause malfunction of the instrument.
168
■
Make sure the meter is powered off. Unplug the power adapter.
■
Do not spray anything onto the meter housing.
■
Do not spray into the test strip guide.
■
Do not immerse the meter in liquid.
■
Use only ordinary lint-free tissues.
■
Do not use cloths that are saturated. Squeeze off excess solution or
blot on a dry paper towel to remove any excess solution before wiping
the surface of the meter.
Maintenance and Care
Recommended cleaning/disinfecting agents
Before using a cleaning/disinfecting solution on the meter refer to the product labeling for
required contact time for cleaning/disinfecting and to ensure that the active ingredients are
acceptable for use. Prepare all solutions per the manufacturer’s product labeling.
Acceptable active ingredients are listed below.
Recommended cleaning agents
■
mild soapy water
■
70 % (or less) solution of isopropyl alcohol in water
■
0.625 % (or less) solution of sodium hypochlorite in water (bleach)
Recommended disinfecting agents
■
0.625 % (or less) solution of sodium hypochlorite in water (bleach)
■
quaternary ammonium compounds up to 0.5 % (single compound or mixture) in isopropyl
alcohol (isopropanol) up to 55 %*
NOTICE
Do not use any other disinfectants/cleaning agents on the meter
(housing or the test strip guide cover). Use of other disinfectants/
cleaning agents could result in damage to the meter.
Cleaning/disinfecting the exterior (meter housing)
Use only the solutions recommended above.
Basic sequence of steps for cleaning
■
First remove any blood and other dirt using water or soapy water.
■
Then disinfect the meter's housing.
169
Maintenance and Care
Cleaning after contamination due to mispipetting
Observe the following precautions to prevent instrument damage
■
Do not move the meter to prevent liquids from creeping and penetrating the meter.
■
Dab away all visible blood (also on the test strip, but not in the application area).
■
Do not use the meter before the liquid/moisture has been completely removed. While it
is drying, the meter must not be moved as this may soil the optical components.
For detailed cleaning instructions (“how to clean…”) for the individual components of the meter,
see the following pages. The instructions below describe only the sequence of steps to be taken
in case of mispipetting.
■
With the meter powered off, remove the test strip guide cover.
■
Remove and dispose of the test strip.
■
Clean the soiled parts of the meter with a moistened cotton swab/bud or tissue.
■
Disinfect the meter.
170
Maintenance and Care
Cleaning the test strip guide cover
If required, remove the meter from the
Handheld Base Unit and place it horizontally on a table.
Remove the test strip guide cover by pulling it forward horizontally (in the direction
of the arrow).
Move the cover safely away from the
meter and wipe it clean using the solutions recommended above.
In case of significant soiling or contamination, you can rinse the test strip guide
cover with warm water, dry it with a fresh
tissue, and then disinfect it using the solutions recommended on page 169.
Always ensure that the test strip guide
cover is completely dry before re-attaching it to the meter.
Clean the outside of the meter with a
lightly moistened tissue. Then dry the
meter with a fresh tissue.
171
Maintenance and Care
Cleaning the visible area of the test strip guide
Clean the easily accessible and visible
pipetting field area of the test strip
guide with moistened lint-free tissues.
Then dry the test strip guide with a fresh
tissue.
Adhere to the following:
172
■
Clean only the visible area of the test
strip guide.
■
Do not insert any objects into the concealed areas of the test strip guide as this
will damage the optical components of
the meter.
■
Do not use objects to try to scratch off any
dried contaminants in the test strip guide.
Clean the membrane (small circle) in the
visible area at the end of the test strip
guide with a moistened tissue.
Allow the inside of the test strip guide to
dry for about 10 minutes.
After this time, re-attach the test strip
guide cover to the housing. Make sure
that the cover is properly attached. You
will feel it snap into place.
Troubleshooting
Troubleshooting
The cobas h 232 meter continually checks its systems for unexpected and unwanted conditions.
These may arise for technical reasons (defective components or consumables, environmental
factors) or due to handling and procedure errors.
Depending on the circumstances, a message may appear on the display of the meter. These
messages are marked with an icon, either
for a status message, or
for an error message.
All messages displayed by the system are accompanied by a description of the error and a possible solution.
Take the action suggested on screen to resolve the problem. If the error disappears, you may
continue using the meter as desired. If the problem persists, contact Roche (see page 197).
The two different message types are illustrated below:
Display/symptom
Description
I-001: Battery Low
Battery Low
I-001
The battery is getting low.
Replace or recharge battery
pack as soon as possible.
Status message
Touch
to proceed with the next step.
E-101: Patient ID
Required
Patient ID Required
E-101
A patient ID is required.
Enter a valid patient ID.
Error message
Touch
to exit this message. Perform the suggested step(s) to
solve the problem.
173
Troubleshooting
Errors and unusual behavior without error messages
Some conditions may arise that have no associated error or status message.
Display/symptom
Description
No message or unusual behavior
Meter display does not
power on
■
Wait 10 seconds and try powering on the unit again.
■
Check that the meter has power.
• If you are using the external power adapter, is it connected
properly to the meter?
Or:
• Place the meter in the Handheld Base Unit.
Or:
• If you are using the Handheld Battery Pack, is it properly
installed in the meter?
Meter displays an
unexpected result
Refer to the package insert for the test strips.
Automatic shutdown
The meter powers off after a configurable time without activity (e.g.,
pressing a key, touching the screen) to conserve energy. Reactivate
the meter/screen as described in the following:
Shutdown after time spec- ■ Press the On/Off button of the meter.
ified by system administrator (default is 5 minutes,
configurable by system
administrator)
174
Troubleshooting
Display/symptom
Description
Communication Problems with the Data Management System via RF
The cobas h 232 meter is
unable to communicate
with the Data Management System.
■
Check WLAN functionality on the meter (see the Wireless
Setup screens in section “Diagnostics” starting on page 80).
■
Dock the RF enabled meter into a hard-wired base unit to
transfer the data.
■
Reset the meter (see page 176).
■
If the error persists, contact your Roche representative.
175
Troubleshooting
Meter reset
A meter reset should only be performed if all other remedies have failed.
09:15 am
Self-Check
Self-Check
Place the meter on a level surface.
Press the
button for at least
12 seconds.
■
The meter powers off and on again.
■
The Roche logo is displayed.
If the Roche logo does not appear within
60 seconds, place the meter in the Handheld Base Unit for a minimum of
15 minutes to recharge the battery.
■
The meter performs a system check.
■
The screens for entering the date and the
time appear.
Enter the date and time. After you have
entered the correct information, confirm
each screen with
■
Unless all lockouts are disabled (see
chapter 3.4), the meter will now be in QC
Lockout due to the manually entered
date/time.
Synchronize the meter’s date/time with
the date/time of your facility via the Handheld Base Unit or, if working wirelessly,
wait at least ten minutes for the next
WLAN synchronization before performing
any further tests.
09:15 am
Performing self-checks...
SW Version: 04.00.00
04/19/2015
Self-checks complete.
SW Version: 04.00.00
04/19/2015
Set Date
Year:
2015
Month:
Set Time
Hour:
Day:
Minutes:
04/19/2015
49
AM
04/19/2015
PM
Even if your configuration does not require it,
we recommend always performing a QC test
after a meter reset.
176
General Product Specifications
10 General Product Specifications
10.1 Operating conditions and technical data
Technical data
Temperature range
18-32 °C
Relative humidity
10-85% (no condensation)
Maximum altitude
4300 m
Position
Always place the meter on a level, vibration-free surface when
applying the sample to the sample application area of the test
strip. Once the sample has been completely absorbed by the
test strip, you can move the meter.
Measuring range
Depends on test parameters
Memory
2000 Patient Test Results
500 QC Test Results
200 IQC Test Results
100 Strip Code Chips
100 QC Code Chips
4000 Patient List entries
5000 Operator List entries
Interface
Infrared interface, LED/IRED Class 1
Supported barcodes
Code 128, Code 39, Code 93, EAN 13, Interleaved 2 of 5,
Codabar, QR Code, DataMatrix, PDF417, Aztec
Battery operation
Handheld battery pack
Mains connection
Power adapter:
Input: 100-240 V AC (± 10%) / 50-60Hz / 350-150 mA
Output: 12 V DC / 1.25A
Number of tests with fully
charged battery
approx. 10 tests
Safety class
III
Automatic power-off
Programmable 1 … 60 minutes
Dimensions
275  102  55 mm
Weight
approx. 650 g incl. battery pack and scanner
177
General Product Specifications
Sample material
Sample type
Heparinized venous whole blood
Sample size
150 μL
Interactions
Refer to test strip package insert
Storage and transport conditions
Temperature range
–25 °C to +70 °C
Relative humidity
10 to 85% (no condensation)
10.2 Further information
Ordering information
Please contact your specialist supplier.
Item
Description
REF
Roche CARDIAC POC Troponin T
10 tests for quantitative detection of cardiac
Troponin T
07007302190
Roche CARDIAC POC Control
Troponin T
Control set for use with Roche CARDIAC POC
(control set for 2 x 6 quality control checks, level
1/2, and code chip)
07089643190
Roche CARDIAC T Quantitative
(Troponin T)
10 tests for quantitative detection of cardiac
Troponin T
04877772190
Roche CARDIAC Control Troponin T Control set for use with Roche CARDIAC T
Quantitative (control set for 2 x 6 quality control
checks, level 1/2, and code chip)
04890515190
Roche CARDIAC Control Troponin T Control set for use with Roche CARDIAC T
(Germany only)
Quantitative (control set for 2 x 6 quality control
checks, level 2, and code chip)
05453879190
Roche CARDIAC M
20 tests for quantitative detection of myoglobin
04877799190
Roche CARDIAC Control Myoglobin Control set for use with Roche CARDIAC M
(control set for 2 x 6 quality control checks,
level 1/2, and code chip)
04890469190
Roche CARDIAC D-Dimer
10 tests for quantitative detection of D-Dimer
04877802190
Roche CARDIAC Control D-Dimer
Control set for use with Roche CARDIAC
D-Dimer (control set for 2 x 6 quality control
checks, level 1/2, and code chip)
04890523190
178
General Product Specifications
Item
Description
REF
Roche CARDIAC proBNP+
10 tests for quantitative detection of NT-proBNP
(measuring range 60 - 9,000 pg/mL for meter
software version ≥ 01.04.01)
05533643190
Roche CARDIAC Control proBNP
Control set for use with Roche CARDIAC proBNP+
(control set for 2 x 6 quality control checks,
level 1/2, and code chip)
04890493190
Roche CARDIAC CK-MB
10 tests for quantitative detection of CK-MB
04877900190
Roche CARDIAC Control CK-MB
Control set for use with Roche CARDIAC CK-MB
(control set for 2 x 6 quality control checks,
level 1/2, and code chip)
04890426190
Roche CARDIAC IQC
Set of two re-usable control strips (high/low)
including code chip. Needed for checking the
performance of the meter’s optical system
04880668190
Roche CARDIAC pipettes
20 disposable syringe pipettes (150 μL) for blood
application
11622889190
Universal battery pack
Rechargeable battery pack for cobas h 232
meter
04805640001
Test strip guide cover
04990315001
Battery compartment cover
04990307001
Power adapter
07006098001
Handheld Base Unit
04805658001
cobas h 232 meter
Standard version without scanner
04901126190
cobas h 232 meter with scanner
Patient/Operator ID can be scanned from a
barcode
04901142190
cobas h 232 Operator’s Manual
Printed manual (English)
07469101001
cobas h 232 Operator’s Manual
Printed manual (German)
07532920001
cobas h 232 Manual CD
Contains Operator’s Manuals and Quick Reference Guides in all available languages (PDF)
07469314001
Printer cobas h 232 (CMP-10)
ROW
for most North American, Latin American and
Asian countries
05404495001
Printer cobas h 232 (CMP-10)
EMEA
for most European, Middle East and African
countries
05404517001
Printer cobas h 232 (CMP-10)
JAP
for Japan
05404509001
Normal thermal paper roll
5 rolls per package, 50 mm diameter
03666751001
Thermal paper roll (self-adhesive)
10 rolls per package, 50 mm diameter
05412951001
Note: Not all items are available in all countries.
179
Warranty
Product limitations
Please read the information in the package insert supplied with the test strips for detailed
product data and limitations.
Information about software licenses
This product incorporates software modules developed under open source licenses. The source
code of this software can be requested on a standard data exchange medium from the manufacturer at the following address:
Roche Diagnostics GmbH
Sandhofer Str. 116
68305 Mannheim, Germany
The General Public License (GPL) licensing conditions are available (in English only for legal reasons) as a text file (file name “License_txt.PDF”) on the CD supplied with this manual. The complete license agreements are also stored as a text file (file name “license.txt”) on the Handheld
Base Unit. You can access this file by connecting the base unit to a PC with the USB cable. For
detailed instructions on how to do this, see the Operator's Manual of the Handheld Base Unit.
Everyone is permitted to copy and distribute verbatim copies of this license document, but
changing it is not allowed.
Repairs
Please note that repairs and other modifications to the meter may only be performed by persons
authorized by Roche.
11 Warranty
The statutory guarantee provisions on rights in consumer goods sales in the country of purchase
shall apply.
180
A
Appendix
A.1 Working with barcodes
Risk of barcode read errors
WARNING
If a barcode is read incorrectly, this may lead to patient misidentification
and therefore to inappropriate therapy decisions.
When creating patient or operator barcodes, always adhere to the
applicable international IEC/ISO standards for the respective barcode
symbology. In particular, ensure that barcode size and print quality (as
defined in ISO/IEC 15416 and 15415) are adequate. Inadequate print size
and/or quality may lead to erroneous decoding. In addition every user
must carry out a plausibility check on all data scanned into and displayed
by the instrument.
To reduce the probability of the barcode being misread, it is strongly recommended that you use
the configuration options for patient and/or operator ID validation as applicable to your specific
workflow. These options are:
■
check ID against list or
■
check ID for length1
■
check if the scanned bar code type is allowed and activated in the DMS
■
use barcodes with check digits
In combination with the above options or as a single measure, use an appropriate barcode mask
if this is compatible with the structure of your barcode content.
Always make sure that the entire barcode is covered by the green light frame when scanning.
1.
If no operator/patient list can be used, it is recommended that you at least set a minimum length for
the respective ID, even if your facility uses IDs of varying length.
181
A.2 Operator and patient ID barcode masks
Barcode mask character
Definition
A-Z, 0-9
If not preceded by the Caret (“^”), the scan data character must be the
same as the mask character. This character is not saved as part of the ID. If
the characters are not the same, the scan data is not a valid ID.
Dollar (“$”)
The scan data character in this position is kept as part of the ID.
Asterisk (“*“)
The scan data character in this position is not kept as part of the ID.
Tilde (“~”)
The scan data character in this position must be a number, 0-9, and it is not
kept as part of the ID. If the scan data character is not a number, the scan
data is not a valid ID.
Plus (“+”)
The scan data character in this position must be an alpha character, A – Z,
and it is not kept as part of the ID. If the scan data character is not an alpha
character, the scan data is not a valid ID.
Caret (“^”)
This mask character denotes that the scan data character must be equal to
the next character in the barcode mask after the “^”, and that the scan data
character is kept as part of the ID. If the scan data character is not equal to
the mask character following the “^”, the barcode reading is invalid as an
ID.
The allowed maximum length of a barcode mask is
■
60 characters for 1D barcodes
■
300 characters for 2D barcodes
182
A.3 Example of barcode symbologies
EAN 13 barcodes, although widely used in retail, are less recommendable for patient/
operator barcodes. If used nonetheless:
■
they demand the very highest quality standards of barcode creation and reproduction
■
the start sequences 978 (ISBN) and 979 (ISMN) may not be used and will be ignored as a
part of any ID code
The use of Interleaved 2/5 barcodes is not recommended.
The barcode samples shown here are for illustration purposes only. If printed out, they can be
used to check the barcode scanner. However, they are not meant to be used as a reference for
size or resolution of real patient or operator ID barcodes. When creating patient or operator barcodes always refer to the relevant standard ISO/IEC 15416 and 15415 for size and resolution
requirements and to the specification listed below.
Recommended Specification
Remarks
Print resolution
300 dpi preferred
200 dpi minimum
At 200 dpi issues with the wide-tonarrow ratio may exist.
Reflective contrast
70% or greater
Matte finish is preferred over gloss
finish.
Symbol grade
Grade C or above
Grade B is preferred
Depending on quality grade
parameters for a specific bar code,
grade C may not be sufficient
when motion, reflection, or poor
lighting occur.
Symbol grades are A-F based on
analysis of several quality elements.
Module width
(minimum)
0.16 mm (linear barcodes)
0.20 mm (2D barcodes)
183
Codabar
Code 39
Code 93
Code 128
EAN 13
Interleaved 2/5
without checksum
PDF417
Aztec
Roche Professional Diagnostics
Roche Professional Diagnostics
DataMatrix
Roche Professional Diagnostics
184
QR Code
Roche Professional Diagnostics
A.4 Supported characters in 2D barcodes
The 2D barcode scanner is able to read characters from the following unicode ranges:
■
Basic Latin (0021-007E)
■
Latin-1 Supplement (00A1-00FF)
■
Latin Extended-A (0100-017F)
The 2D barcode scanner does not support Asian characters.
185
This page intentionally left blank.
186
B
Appendix
B.1 Option: Wireless network (WLAN)
Preliminary note
Appendix B has been developed to explain the wireless communication principles of the
cobas h 232 system1 and to help your facility’s information technology/management team(s) in
effectively deploying the cobas h 232 system on your wireless network.
Whether your meter has wireless capability or not depends on the system configuration that you
purchased.
Background
The cobas h 232 meter can only be configured through a data management system to communicate wirelessly. The data management system is also used to set-up and configure the meter to
connect to one hospital specific Wireless Local Area Network (WLAN2). WLANs use electromagnetic waves in the 2.4 and/or 5.0 GHz frequency range to wirelessly transmit data3. The
cobas h 232 system adheres to IEEE Standard 802.11g (2.4 GHz range)4. The system is backwards compatible to 802.11b. During wireless communication to an Access Point (AP), the
cobas h 232 meter recognizes the existent AP WLAN protocol configuration (802.11b or 802.11g)
and automatically transmits data using the appropriate communication protocol5.
1.
2.
3.
4.
5.
The cobas h 232 system is certified by the Wi-Fi Alliance.
WLAN is also commonly referred to as wireless LAN or Wi-Fi.
For the wireless functionality to work properly, the wireless module must first be configured by your
system administrator.
While the cobas h 232 system adheres to the 802.11g standard, it uses only channels 1-11. Channels
12-14 are not used by the system.
WLANs are organized in cells. A typical WLAN cell consists of Access Point(s) that are connected to
the (wired) Local Area Network and one or more clients, e.g., cobas h 232 meters along with other
clients such as portable computers.
187
The loss of signal or access to bandwidth of one particular client may vary depending on one or
more of the following situations: the type and number of other clients, the performance of the
Access Point, the presence of electromagnetic disturbances, and other potential interfering factors, e.g., concrete walls.
The cobas h 232 meter uses a burst-like communication protocol that will only consume bandwidth if there is actually data to be transferred. Compared to other applications, such as Voice
over Internet Protocol (VoIP) or multi-media applications, the meter’s bandwidth consumption is
minimal. If the WLAN that the cobas h 232 meter seeks to connect to is degraded, the meter
design minimizes the impact on functionality.
Technical implementation
Prior to connecting any wireless device to a wireless network, it is recommended that a WLAN
site survey be performed. The goal of a WLAN site survey is to ensure that Access Points will provide enough coverage and performance to support any new radio frequency (RF) application or
device. The survey will also detail RF signals, including all existing WLANs along with any competing RF signals and interferences (building structure related and other wireless equipment /
devices).
As part of an RF implementation of the cobas h 232 system, it is recommended that at minimum
one base unit be hard wired per floor. A networked base unit provides redundancy if a wireless
network malfunctions or loses service. If the cobas h 232 meter with RF is used in an area with
low signal or interferences, it is recommended to install a connected base unit for redundancy.
The redundancy of the connected base unit allows immediate transmission of patient results
when the meter is docked.
188
The current RF system consists of an antenna and a WLAN system-on-chip (SoC) along with
other components. The WLAN system-on-chip is the core of the WLAN system. The RF system
used in the cobas h 232 meter specifically adheres to the following specifications:
■
Its WLAN system-on-chip supports IEEE 802.11b and 802.11g. It works seamlessly
together with other Wi-Fi certified transceivers. It also implements the Wi-Fi Protected
Access (WPA™ - Enterprise and WPA™ - Personal), Wi-Fi Protected Access 2
(WPA2™ - Enterprise and WPA2™ - Personal), and Wired Equivalent Privacy (WEP) security mechanisms with Temporal Key Integrity Protocol (TKIP) and Advanced Encryption
Standard (AES).
In addition, the system supports the extensible authentication protocol (EAP) with
EAP-TLS, EAP-TTLS/MSCHAPv2 and PEAPv0/EAP-MSCHAPv2. The cobas h 232 meter
interoperability Wi-Fi certificate can be accessed at
http://certifications.wi-fi.org/search_products.php.
Further information including a glossary of terms, frequently asked questions, and other
topics related to Wi-Fi technology can be found on the Wi-Fi Alliance site
(http://www.wi-fi.org/).
■
The used channels in the 2.4 GHz-band are channels 1-11. (Channels 12-14 are not used
by the cobas h 232 meter.)
■
RF output power is approximately 15 dBm at a data rate of 54 MBPS.
189
RF specific functionalities and effective performance claims
The cobas h 232 system offers the option of wireless network connectivity (WLAN/Wi-Fi). If you
purchase a system with this option, the WLAN function is enabled during production.
This module can only be configured by a data management system (DMS), which activates the
meter’s wireless communication and data transfer capabilities. Wireless connectivity can help to
ensure that updates to information in the DMS are sent immediately to all networked meters.
Meters with an integrated and activated wireless option use the base unit for recharging and/or
as a redundant communication option to exchange data with the DMS.
The meter also has to be docked if the hospital changes security protocols. When this change
occurs, it may lock out all meters until docked and reconfigured with the new protocol.
As described above, the cobas h 232 meter supports the 802.11g standard. This translates into
the following RF specific performance claims:
■
The cobas h 232 meter is capable of transferring to a suitable DMS, via WLAN, a data set
of up to 1000 result records, 100 reagent records, and 500 operator ID records in less than
15 minutes, when operated in a typical WLAN environment (correct WLAN administration, typical population of other clients present, any of the supported security models enabled).
■
A cobas h 232 meter with wireless connectivity enabled will communicate results after
every test or when the meter is idle; it will automatically attempt to communicate with the
DMS every 10 minutes. In line with the industry communication standard POCT1-A, the
DMS must acknowledge the meter’s request for connection and actively query for the
result. Only upon receipt of this DMS query, the meter will send the result. Hence the
effective time for transmitting results depends on infrastructure, DMS workload, etc.
Once the DMS sends a query, however, the meter will respond within a few seconds.
190
A typical range for direct connection between the cobas h 232 meter and the access point (air,
direct view, low disturbances) is up to 15 to 20 meters (49 to 66 feet). The actual range depends
on the positioning of the access point’s antennas and other topological properties of the space
between WLAN device and AP. Additionally, dynamic control of the transmitting power of the
access point may reduce the maximum distance between WLAN device and AP within which
communication can be guaranteed.
The cobas h 232 system is designed such that it coexists with other wirelessly communicating
devices. The cobas h 232 system does NOT include any real-time or even time critical wireless
functionality. It communicates exclusively single, digital data fields. It does NOT communicate
continuous waveform data.
Note: A degraded Quality of Service (QoS) of the WLAN communication will not impact the
functionality of the meter but may delay the communication of results to the DMS. Users
should be aware that real-time communication of test result readings cannot be guaranteed by the cobas h 232 meter.
191
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192
C
Supplement for Observed Test Sequence
Observed Test Sequence (OTS)
The Observed Test Sequence (OTS) function allows an observer (supervisor) to assess and record
an operator’s performance (e.g., for recertification purposes). The observer monitors an operator
during a test to check that the test is being performed according to the recommended procedures. He/she then evaluates the performance and passes or fails the operator. This assessment
is saved together with the test result and any desired comments.
Observed Test Sequence options can only be configured using a DMS. The availability of
electronic configuration options will thus vary according to the data management software
utilized by your institution. Consult your system administrator.
193
Using the OTS function
A request for an Observed Test Sequence comes from the DMS. The presence of the
on the Patient Test button indicates a pending OTS request.
Observer:
09:15 am
Main Menu
Patient Test
Review Results
Setup
Pat. Test - OTS
Logout
OTS enabled
Touch Observer Login.
Wait until the observer list is displayed.
Select your observer ID by touching the
corresponding button, or scan your
operator ID (which is also your
observer ID in this case)..
Observer Login
Patient Test
Observer
04/19/2015
09:15 am
Alan Smithee
Ann Casey
Only operators with OTS observer rights are
listed in the Observer Login list.
Enter the (optional) password.
After you enter your password, touch
to log in. The Pat. Test - OTS menu is displayed again. The Patient Test button is
now active.
Hand the meter to the operator who can
now perform the patient test under
supervision.
Pat. Test - OTS
Scan
04/19/2015
OTS enabled
Observer Login
Patient Test
04/19/2015
194
Touch Patient Test.
In the Pat. Test -OTS menu, the Patient Test
button is grayed out (disabled) until the
observer has logged in.
Control Test
04/19/2015
icon
Pat. Test - OTS
Operator:
Remove Strip
OTS enabled
Observer Login
Perform the patient test as usual. Once the
test is completed, the observer has to complete the next steps.
Remove Strip
Patient Test
04/19/2015
Observer Login
09:15 am
Touch
After you enter your password, touch
to proceed with the assessment.
Assess the operator’s performance by
touching Pass or Fail.
Assess the test result by touching Accept
or Reject.
Touch
to add a comment.
Touch
screen.
to return to the Pat. Test - OTS
OTS passed:
I-010
Observer ALAN SMITHEE,
please log in to proceed.
Otherwise the OTS test will
not be complete.
Pass
Fail
Measurement Result OK?
Reject
Comment:
04/19/2015
Hand the meter back to the observer.
Observer:
04/19/2015
Observer
Touch Patient Test.
Accept
to log in again.
The OTS information is saved together with
the test result.
195
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196
D
Contact Roche
For all questions about the cobas h 232 system that are not answered in this manual, contact
your Roche representative. If you do not already have contact details, visit our website on
www.roche.com. Select "Roche in your country" at the top of the page and then select your country to find the appropriate local office contact information.
The cobas h 232 system is manufactured for and distributed by:
Roche Diagnostics Australia Pty Limited
ABN 29 003 001 205
31 Victoria Avenue
Castle Hill, NSW, 2154
197
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198
Index
Administrator ..................................................... 83
Administrator ID
Change ......................................................... 87
Disable ......................................................... 88
Set up .................................................... 83–86
Application area ............................................... 29
Apply sample ................................................... 129
Opening (meter) ....................................... 25
Auto off ................................................................ 62
Barcode ................................................... 121, 126
Masks ......................................................... 182
Symbologies ............................................. 184
Barcode (test strip) .......................................... 29
Barcode reader ................................................. 29
Barcode scanner .............................................. 25
Basics (setup) ............................................. 49–63
Battery pack ....................................................... 27
Installing or replacing ...................... 36–40
Cleaning .................................................. 167–172
After mispipetting .................................. 170
Housing - outside .................................. 171
Test strip guide ....................................... 172
Cleaning lockout ............................................ 106
cobas h 232
Contents of the pack .............................. 13
Introduction ................................................ 11
Operating conditions ............................ 177
Overview of meter elements ......... 24–26
Test principle ............................................. 13
cobas IT 1000 .................................................... 11
Code chip ......................................... 29, 116–117
Opening ....................................................... 26
Comment (custom) ....................................... 134
Comment result .............................................. 134
Computer ............................................64–68, 160
Connection .................................................. 64–70
Contact Roche ................................................ 197
Contents of the pack .......................................13
Contrast .........................................................49–50
Control material .............................................. 138
Custom range ........................................103, 104
Data handling .............................................64–81
Data Management System
(DMS) ....................................73, 83, 91, 92, 159
Data transfer ................................................... 159
Date ................................................................53–54
Diagnostics ..................................................80–81
Display format .............................................57–58
Disposal ...................................................... 17, 115
Error messages ............................................... 173
Handheld Base Unit .........................................36
Handheld battery pack ............................25, 35
Icons: see Symbols
ID setup .........................................................82–93
Overview ......................................................82
Infections (safety instructions) ................. 115
Infrared interface .................................... 26, 159
IQC lockout ...................................................... 101
Language ......................................................51–52
Lockout ....................................................... 94–108
Cleaning lockout .................................... 106
IQC lockout .............................................. 101
New lot lockout ...................................... 100
Operator lockout ................................95–97
QC lockout ............................................... 100
199
M
Meter
Reset ...........................................................176
Meter setup
Administrator ID ................................ 83–86
Auto off ........................................................ 62
Basics .................................................... 49–63
Cleaning lockout ....................................106
Computer ............................................. 64–68
Contrast ................................................ 49–50
Data handling ..................................... 64–81
Date ........................................................ 53–54
Diagnostics .......................................... 80–81
Display format .................................... 57–58
ID setup ................................................ 82–93
IQC lockout ...............................................101
Language ............................................. 51–52
Lockout ...............................................94–108
New lot lockout .......................................100
Operator ID .......................................... 89–91
Operator lockout ............................... 95–97
Optional screens ........................... 109–111
Overview ............................................... 44–48
Patient ID .............................................. 92–93
Printer .................................................... 69–70
QC lockout ................................................100
QC result format ........................... 102, 103
QR Code ............................................... 65–67
Reset test parameters ...........................105
Result confirmation ...............................111
Result display mode ......................... 78–79
Result login ...............................................110
Result memory ................................... 71–74
Result unit ............................................ 75–77
Sound .................................................... 59–61
Start info ....................................................110
STAT test ...................................................107
Time ........................................................ 55–56
200
New lot lockout .............................................. 100
Observed Test Sequence (OTS) ......193–195
On/Off button .....................................................25
Operating conditions .................................... 177
Operating the meter ................................. 35–??
Operator ID .............................. 89–91, 120–122
Operator list ............................................121, 161
Operator lockout ....................................... 95–97
Optional screens ...................................109–111
Ordering information .................................... 178
Overview of meter elements ................. 24–26
Patient ID .................................. 92–93, 124–126
Patient list ...................................... 124–126, 162
Power adapter
Connection .......................................... 26, 30
Power supply ......................................................27
Contacts (Handheld Base Unit) ..........26
Powering on the meter ............. 119, 139, 151
Printer ............................................................ 69–70
Product specifications ................................. 177
QC lockout ....................................................... 100
QC result format ....................................102, 103
Quality control ........................................137–149
Control material ...................................... 138
IQC (instrument-specific) ..........147–149
Pass/Fail .................................................... 149
Preparation ............................................... 137
QC (test parameter-specific) ....139–145
R
Reset ................................................................... 176
Reset test parameters .................................. 105
Result confirmation ............................. 111, 133
Result deletion (automatic) .......................... 74
Result display mode ................................. 78–79
Result login ............................................ 110, 132
Result memory ..................................71–74, 151
Result unit .................................................... 75–77
Review results ....................................... 151–164
All results .................................................. 154
Data transfer ............................................ 159
IQC (instrument quality control) ....... 156
Maintenance ............................................ 157
Patient history .......................................... 153
QC (quality control) ............................... 155
RF (radio frequency) ..............................22, 188
Safety
Protection against infection ................. 15
User qualification ..................................... 15
Sample material .................................... 115, 178
Scan (button) ......................................... 121, 126
Self-check (powering on the meter) ...... 119
Software license ............................................. 180
Sound ............................................................ 59–61
Specifications .................................................. 177
Start info ............................................................ 110
STAT Test ............................................................ 94
Perform ...................................................... 136
STAT test
Configure .................................................. 107
Storage ............................................................... 165
Storage and transport conditions ............ 178
Symbols
Code chip ........................................ 128, 141
Error messages ....................................... 173
Hourglass ...............................130, 143, 144
Meter ...............................................................5
Packaging ......................................................5
Pipette .............................................. 128, 142
Screen ................................................... 31–33
Thermometer ................................. 128, 142
Test ............................................................113–136
Performing .......................................123–136
Preparing .........................................115–122
Sample material ..................................... 115
Test area ..............................................................29
Test principle ......................................................13
Test steps (overview) ................................... 118
Test strip
Inserting ...........................................127, 140
Lot ..................................................................98
Test strip guide ..................................................26
Test strip guide cover .....................................25
Time ................................................................55–56
Touchscreen ................................................25, 43
Troubleshooting ............................................. 173
Wi-Fi ......................................................................22
WLAN ................................................................. 187
201
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202
Roche Diagnostics GmbH
Sandhofer Strasse 116
68305 Mannheim, Germany
www.roche.com
www.poc.roche.com
0 7469101001 (01) 2015-XX EN
ROCHE CARDIAC, COBAS, COBAS H
and IQC are trademarks of Roche.

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