Roche cobas h 232 is a cutting-edge medical device designed to deliver fast and accurate cardiac testing results in various clinical settings. With its user-friendly interface and advanced technology, the cobas h 232 empowers healthcare professionals to make informed decisions promptly, aiding in effective patient care.
Roche cobas h 232 is a cutting-edge medical device designed to deliver fast and accurate cardiac testing results in various clinical settings. With its user-friendly interface and advanced technology, the cobas h 232 empowers healthcare professionals to make informed decisions promptly, aiding in effective patient care.
cobas h 232
Supplement to the Operator's Manual V4.0
2
Purpose of document
This document provides a description of changes to the Operator’s Manual version 4.0 for
SW 03.02.xx. This supplement is valid for and intended to be used in conjunction with the
cobas h 232 Operator’s Manual version 4.0. It is not a replacement for the complete
cobas h 232 Operator’s Manual version 4.0. Changes or additions to the information in the
cobas h 232 Operator’s Manual version 4.0 are shown in colour.
© 2020-2021 Roche Diagnostics GmbH
The contents of this document, including all graphics, are the property of Roche Diagnostics. No
part of this document may be reproduced or transmitted in any form or by any means, electronic
or mechanical, for any purpose, without the express written permission of Roche Diagnostics.
Roche Diagnostics has made every reasonable effort to ensure that all the information contained
in this supplement is correct at the time of printing. However, Roche Diagnostics reserves the
right to make any changes necessary without notice as part of ongoing product development.
Please send questions or comments about this document to your local Roche representative.
ROCHE CARDIAC, COBAS, COBAS H and IQC are trademarks of Roche.
Document version Date Content
1.0 2020-05 New Document, created as an amendment to
Operator's Manual Version 4.0
2.0 2021-03 Added information about TLS Encryption.
Be sure to read the complete cobas h 232 Operator’s Manual version 4.0.
Table of Contents
3
What is new in SW 03.02.xx 5
Functions introduced with SW 03.02.xx ...................................................................................................... 5
Settings summary............................................................................................................................... 5
Computer............................................................................................................................................... 7
Memory.................................................................................................................................................. 8
Result Retention ................................................................................................................................. 8
Delete Database ................................................................................................................................. 9
Diagnostics......................................................................................................................................... 10
Amendments to Operator’s Manual version 4.0 11
Revised sections................................................................................................................................................. 11
Performing a test.............................................................................................................................. 11
Control Testing and Quality Control.......................................................................................... 12
Troubleshooting................................................................................................................................ 14
Additional information on error E-201 and information message I-007 ..................... 14
Further information.......................................................................................................................... 14
Table of Contents
4
This page intentionally left blank.
5
What is new in SW 03.02.xx
Functions introduced with SW 03.02.xx
Settings summary
The following illustration has been revised on page 30:
Setup
Data
Handling
ID Setup
Basics
LanguageContrast
Connection
Administrator ID
Operator
Lockout
Start Info
Date/Time
QC Settings
Result Login
Sound
Operator ID
Cleaning
Lockout
Result
Confi rmation
Auto Off
Memory
Patient ID
STAT Test
Confi g.
Lockout
Optional
Screens
Result Display
Mode
DD Result Unit Diagnostics
6
The following information has been added or revised on page 32:
* Default settings are labelled with an asterisk (*).
Group
Subgroup Setting
Values
*
Data Handling Connection
Off *
Computer
Printer
Memory
Result Display Filter All results *
Current Op. Res.
Result Storage
Mode
No results deletion *
Delete oldest result
Result Retention Automatic result deletion
On/Off*
Retention time in days:
1 … 30* … 1000
Delete Database Results
Code Chip Data
Entire Database
DD Result Unit
μg/mL *
ng/mL
mg/L
μg/L
Result Display Mode
Static *
Flashing
Diagnostics
Error History
ID Setup Administrator ID
Blank (off) *
Operator ID
None *
Optional
Required
Scan Only
Patient ID
None
Optional *
Required
Hidden List
7
The following information has been changed on page 51:
Computer
4 Touch Computer. Your selection is now
highlighted.
5 Touch to select the desired option for
TLS Encryption next, or touch to exit
this menu without saving any changes.
6 TLS Encryption: Touch On if you want to
turn on encryption for all computer com-
munication. Otherwise touch Off.
7 Touch to save this setting, or touch
to exit this menu without saving any
changes. The display automatically
returns to the Setup-Data Handling
screen.
Off
Computer
Printer
Select Connection
04/19/2014
TLS Encryption:
TLS
04/19/2020
On Off
8
The following information has been changed on page 54:
Memory
Result memory settings allow to apply a Result Display Filter, to set the Result Storage Mode (see
page 56), to set the Result Retention for automatic deletion of test results and to use the Delete
Database menu for manual deletion of stored information.
The following information has been added after page 54:
Result Retention
In the Set Result Retention menu you can enable or disable automatic deletion of test results
after a selectable time period.
1 From the Setup-Memory menu, touch
Result Retention.
You may select from the following deletion
options:
■ Off (test results will never be deleted
automatically)
■ On (test results will be deleted automati-
cally after the time period set below)
2 Touch or to select the time
period in days, after which data will be
deleted automatically.
3 Touch to save this setting, or touch
to exit this menu without saving any
changes. The display automatically
returns to the previous screen.
Result Storage Mode
Result Retention
Delete Database
Result Display Filter
Setup - Memory
04/19/2020
Retention time in days
30
Automatic result
deletion
Set Result Retention
04/19/2020
On Off
9
Delete Database
In the Delete Database menu you can manually delete all test results, code chip data, or the
entire database.
1 From the Delete Database menu, select
the type of data you want to delete:
■ Results (all stored test results)
■ Code Chip Data (all stored code chip
data)
■ Entire Database (all test results, com-
ments, code chip data, operator and
patient IDs)
2 Touch to confirm the deletion, or touch
to exit this function without deleting
data.
Result Storage Mode
Result Retention
Delete Database
Result Display Filter
Setup - Memory
04/19/2020
Code Chip Data
Entire Database
Results
Delete Database
04/19/2020
Sel. Res. Display Filter
Do you really want to delete
all results?
04/19/2020
10
The following information has been added after page 60:
Diagnostics
Use the Diagnostics menu to access the Error History of the meter. All errors occurring during
internal self-checks or regular operation are logged in this list.
1 From the Setup-Data Handling menu,
touch Diagnostics.
2 From the Diagnostics menu, touch Error
History.
3 Touch and to scroll to the entry
of choice on the screen.
Memory
DD Result Unit
Result Display Mode
Setup - Data Handling
Connection
Diagnostics
04/19/2020
Error History
Diagnostics
04/19/2020
Error History
83903009 - CBH
10/02/19 07:57 am
7e802915 - KBM
03/12/18 08:03 am
53800003 - KBM
09/10/19 02:39 pm
7b80291b - KBM
03/12/18 08:03 am
7e802915 - KBM
03/12/18 08:02 am
04/19/2020
11
Amendments to Operator’s Manual version 4.0
Revised sections
Performing a test
The following warning has been added on page 106:
The following text replaces the related text on TnT Elevated messages on page 107.
WARNING
Before use, visually check if the packaging of the Cardiac pipettes and/or
the pipettes are intact. If the needle falls off or gets stuck during use, do
not try to re-cap it. Stop using the pipette immediately and dispose of it
in a sturdy sharps container (in accordance with applicable local regula-
tions and directives and your facility's guidelines).
For Troponin T only:
As soon as the meter detects a signal (this
may take a few minutes), a qualitative
message (TnT Elevated) appears under the
hourglass icon (see illustration).
The final quantitative result is displayed when
the test is completed. Decisions on further
treatment of the patient should be based on
the final result only. Refer to the Roche
CARDIAC T Quantitative or Roche CARDIAC
POC Troponin T package insert for more
details.
Pat. Test - Measuring
Trop T TT 2721
JONES, TOM
Par:
Op:
Code:
SCHULZ, MANFREDPat:
10:20 Min
TnT Elevated
04/19/2020
12
Control Testing and Quality Control
The following warning has been added on page 113.
WARNING
Potential risk of incorrect patient results
Failure to check the system regularly by performing quality control tests
may lead to incorrect results and therefore to inappropriate therapy deci-
sions. To ensure that the system is functioning properly adhere to the
manufacturer recommendations on quality control testing given in the
tables below.
13
Manufacturer recommended frequency of quality control tests:
*only on days when the cobas h 232 meter is used for measurements
Manufacturer recommended use:
QC recommendations by national associations or local hospital guidelines take precedence over
manufacturer recommendations. For more details on the procedure refer to the Operator’s
Manual and Instructions for Use.
Frequency Material to test Reason Release criteria
Daily* CARDIAC IQC High
and
CARDIAC IQC Low
Verification of the proper
functioning of the optical
system
Both levels are “Pass”
Frequency Material to test Reason Release criteria
Once a month
Roche CARDIAC Controls
To verify adequate
storage at customer site
Results are within the
range provided by the
manufacturer
With each new shipment
of test strips
To verify proper function-
ing after transportation to
customer site
When an implausible
result is obtained
When an operator uses
the cobas h 232 system
(meter with or without
scanner) for the first time
To qualify the new
operator; to verify proper
handling and sample
dosing
After adverse events such
as dropping the meter or
other strong mechanical
shocks.
Roche CARDIAC Controls
and
CARDIAC IQC High
and
CARDIAC IQC Low
To verify proper function-
ing of the meter
Results are within the
range provided by the
manufacturer
14
Troubleshooting
The following information has been added after page 149:
Additional information on error E-201 and information message I-007
If the meter shows an error E-201 (strip lot expired) or an information message I-007 (wrong
code chip), perform the following steps:
■ Make sure the code chip belongs to the test strip lot in use.
■ Check the date setting of the meter. Correct this setting if necessary.
■ Check the expiration date of the test strip lot. If the lot is expired, continue testing with a
new lot.
■ If the date setting is correct and the test strips are not expired, remove the code chip from
the meter and reset the test parameters as described on page 84 of the Operator’s
Manual version 4.0. When finished, insert the code chip again and perform a test with a
new test strip of the same lot.
If testing is still not possible, contact your Roche representative.
Further information
The following information has been added after page 149:
IMPORTANT NOTE
For Australia only:
Roche Diagnostics Australia has moved. Our new address is as follows:
Roche Diagnostics Australia Pty Limited
ABN 29003 001 205
2 Julius Avenue
North Ryde, NSW, 2113
Our telephone numbers remain unchanged:
02-9860 2222
OR
1800 645 619 (toll free)
15
0 9202412001 (02) 2021-03 EN
ROCHE CARDIAC, COBAS, COBAS H
and IQC are trademarks of Roche.
Roche Diagnostics GmbH
Sandhofer Strasse 116
68305 Mannheim, Germany
www.roche.com
www.cobas.com
www.poc.roche.com
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Roche cobas h 232 User manual
- Type
- User manual
- This manual is also suitable for
Roche cobas h 232 is a cutting-edge medical device designed to deliver fast and accurate cardiac testing results in various clinical settings. With its user-friendly interface and advanced technology, the cobas h 232 empowers healthcare professionals to make informed decisions promptly, aiding in effective patient care.
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