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Cedex HiRes

Roche Cedex HiRes User manual

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Cedex HiRes Analyzer Operator’s Manual
Software Version 2.3.2
October 2020
How to Use the Cedex HiRes Analyzer Guides
Before reading, please review the section “Revision” for important information.
User Training Guide
Provides detailed step-by-step instructions for routine operation using the main applications of
the Cedex HiRes Analyzer, including instrument startup and shutdown.
Quick Guide
Provides a short set of instructions for use in the laboratory, describing the basic handling steps.
This shorter form of information is for routine use after you are familiar with the details of the
Cedex HiRes Analyzer described in the User Training Guide.
Operator´s Guide
Provides a detailed description of the Cedex HiRes Analyzer, system components and all rel-
evant software information not covered by the User Training Guide. For installation requirements,
always refer to the Operator´s Guide.
Revisions
Provides updates to the Cedex HiRes Analyzer Guides, including new supplementary information
and corrections to previous editions.
For use in quality control/manufacturing process only.
Cedex HiRes Analyzer
Addendum 6 to Operator’s Guide, Version 3.0
Software Version 2.3.2 October 2020
2
Cedex HiRes Analyzer – Addendum 6 to Operator’s Guide, Version 3.0
Information Regarding the
Cedex HiRes Analyzer Operator’s Manual,
Software Version 2.3.2
Please read the following update information for the Cedex HiRes Analyzer Operator’s Manual,
Software Version 2.3.2
This addendum includes:
c Complete update of Chapter XI, Warnings and Precautions in the Cedex HiRes Operator’s Guide.
c Information about number of beads that appear in each image is updated in Chapter D, section 7, Automatic
Adjustment and Alignment Verification of the Cedex HiRes Operator’s Guide.
Please note that for each update, corresponding page numbers are provided.
Changes and updates to existing text in the Cedex HiRes Operator’s Manual is highlighted in yellow background.
If you have any further questions regarding this matter, please do not hesitate to contact your local Roche
representative. To call, write, fax, or email us, visit the Custom Biotech homepage, http://custombiotech.roche.com/
Information Regarding the Cedex HiRes Analyzer Operator’s Manual, Software Version 2.3.2
3
Revised Chapter XI, Warnings and Precautions
Page 14 of the Cedex HiRes Operator’s Guide
The following additional safety information applies for the Cedex HiRes Analyzer, Software Version 2.3.2.
Good Laboratory Practice can reduce the risk of injury. Be aware of your laboratory environment, well-
prepared, and follow the instructions for use. Some areas of the instruments may have sharps, rough edges,
and/or moving parts. Wear personal protective equipment to minimize the risk of injury from bodily contact
with such parts, especially in less accessible areas, or while cleaning the instrument. Your personal protective
equipment should be appropriate to the degree and type of potential hazard, e. g. suitable lab gloves, eye
protection, lab coat, and footwear.
Software and data security
Unauthorized system access and data loss
External storage devices can transmit computer malware, which may be used to gain unauthorized access to
data or cause unwanted changes to software.
The system has limited protection against malicious software and hacker attacks.
c Physical access to the product and all attached IT infrastructure (including analyzer, computer systems,
cables, network equipment, etc.) must be restricted at all times.
c A Roche-provided firewall is mandatory if the system is connected to a network to protect and separate
Roche systems from other laboratory infrastructure.
c The laboratory network and any laboratory infrastructure must be secured against unauthorized access,
malicious software, and cyber-attacks.
c All devices and services used in the customer lab infrastructure must be safe and secured against malicious
software and unauthorized access.
c A secure network environment which is resilient to traffic redirection and eavesdropping must be installed.
Roche recommends the following precautions:
c Do not copy or install any software on the system unless it is part of the system software or your Roche
representative tells you to do so.
c If extra software is required, contact your Roche representative to ensure validation of the software in
question.
c Exercise care when you use external storage devices such as USB drives or DVDs.
c Do not connect to the system any external storage device that you use on public or home computers.
c Keep all external storage devices in a secure place, and make sure that only authorized personnel can access
them.
c Back up your data regularly.
Cybersecurity and privacy awareness
c Perform regular security and privacy awareness training for the users to ensure that personal data is
handled in a compliant way and in accordance with the privacy principles that are mandatory by customer
regulations.
c Check your analyzer for suspicious activity and report any suspected compromise immediately to your local
Roche representative.
c Update to the latest software versions provided by Roche. Contact your Roche representative for more
information.
c Read and follow the recommendations and advice written in this chapter.
Information Regarding the Cedex HiRes Analyzer Operator’s Manual, Software Version 2.3.2
Revised Chapter XI, Warnings and Precautions
4
Cedex HiRes Analyzer – Addendum 6 to Operator’s Guide, Version 3.0
The following precautions are mandatory:
c Only use virus free external storage devices for backup purposes.
c Transmit backup data to external storage devices via secure networks only.
c Any data backup and data archive that has been exported from the analyzer must be physically securely
stored and protected from any unauthorized access.
c Data access to any data backup or data archive is permitted to authorized persons only.
c Ensure that data backup and data archives are not taken from the safe and secure storage location.
Data transfer and data entry on analyzer
c Writing patient sensitive information in comment fields can violate patient health information protection
laws. Do not write any patient sensitive information into comment fields, if these laws are applicable for
your country.
c Do not download from any host system (e.g., LIS, middleware) any patient sensitive data to the analyzer.
c Data transfer using any host protocol (e.g., HL7, ASTM) is not encrypted; data is transferred as plain text
and readable with IT tools like sniffers.
Corrupt data due to a disclosed password
c The security of the system and its data depends on the password-protected access. If an unauthorized person
discovers your user ID and password, they could compromise this security.
c Always enter your password unobserved.
c Do not write down your password anywhere, including in a contact form, in the address book, or in a file on
the computer.
c Do not disclose your password to anyone. Roche will never ask you for your password.
c Do not use shared accounts.
c If you ever disclose your password to anyone, change it immediately afterwards.
c Contact your local Roche affiliate if you think your account has been compromised.
c Use a personal user account for each user with appropriate user level.
c Delete any unused user accounts from the analyzer (for example, when a user left).
Non-approved third-party software
Installation of any third-party software that is not approved by Roche Diagnostics may result in incorrect
behavior by the system.
c Correct operation of the Analyzer and Software can only be guaranteed if no other software has been
installed on the Control Unit provided by Roche.
Software installed on Control Units not provided by Roche Diagnostics
The Cedex HiRes Software should be installed on the Control Unit and Windows image provided by Roche
specifically for the Cedex HiRes Analyzer.
c nstallation on Control Units and Windows images not provided by Roche may result in incorrect behavior
by the system. Support is limited for installations on other hardware. For more information, contact your
local Roche representative.
Unreliable validation due to unauthorized changes to the validation settings
The manufacturer shall not be held liable for any consequences resulting from subsequent, unauthorized modi-
fications to the accepted validation settings included in the system at the customer’s request.
c Ensure that only authorized personnel can change, if necessary, the validation settings.
Information Regarding the Cedex HiRes Analyzer Operator’s Manual, Software Version 2.3.2
Revised Chapter XI, Warnings and Precautions
5
Information about number of beads that appear in each
image is updated in Chapter D, section 7, Automatic
Adjustment and Alignment Verification
Page 139 of the Cedex HiRes Operator’s Guide
The information highlighted in yellow updates the current text in the manual.
The focus position automatically set for the four corner areas (optimal position) must lie between 850µm
and 1250µm. Otherwise, an authorized Roche Service representative must re-adjust the Cedex HiRes Analyzer.
Another important value is the allowed maximum difference between the optimal focus values of the four
corner areas. The focus difference must be between ≥ 0µm and ≤ 20µm. Otherwise, an authorized Roche Service
representative must re-adjust the Cedex HiRes Analyzer.
c All of the images have an even distribution of beads with at least 10 beads in every picture, based on the
default setting for the zoom. Do not zoom in or out on the images; check the default images to ensure that
at least 10 beads are present in each image.
The information below highlighted in yellow provides new, additional information about the conditions to
be met during the Automatic Adjustment.
c The borders of the beads are a closed circle and have a similar intensity in all 4 images.
Information Regarding the Cedex HiRes Analyzer Operator’s Manual, Software Version 2.3.2
Information about number of beads that appear in each image is updated in Chapter D, section 7,
Automatic Adjustment and Alignment Verification
Published by
Roche Diagnostics GmbH
Sandhofer Straße 116
68305 Mannheim
Germany
© 2020 Roche Diagnostics.
All rights reserved.
www.custombiotech.roche.com
0102020
For use in quality control/manufacturing process only.
CEDEX is a trademark of Roche.
All other product names and trademarks are
the property of their respective owners.
Cedex HiRes Analyzer
Addendum 5 to Operator’s Guide, Version 3.0
Software Version 2.3.2 June 2016
For use in quality control/manufacturing process only.
2
Cedex HiRes Analyzer Addendum 5 to Operator’s Guide, Version 3.0
3
Software Version 2.3.2
Information Regarding the
Cedex HiRes Analyzer Operator’s Manual,
Software Version 2.3.2
Please read the following update information for the Cedex HiRes Analyzer Operator’s Manual,
Software Version 2.3.2
This addendum includes:
c Information about Cedex HiRes Software version 2.3.4
c Updating from Cedex HiRes Software version 2.3.2 or 2.3.3 to Cedex HiRes Software version 2.3.4
c Information about exchanging the fuse
If you have any further questions regarding this matter, please do not hesitate to contact Roche
Technical Service at your convenience. To call, write, fax, or email us, visit the Custom Biotech homepage,
http://custombiotech.roche.com/
Information Regarding the Cedex HiRes Analyzer Operator’s Manual, Software Version 2.3.2
4
Cedex HiRes Analyzer Addendum 5 to Operator’s Guide, Version 3.0
Information About Cedex HiRes Software Version 2.3.4
All the functions and features described in the Cedex HiRes Analyzer Operator’s Manual, Software Version
2.3.2, also apply to Cedex HiRes Software version 2.3.4.
For more information about the functions and features of Cedex HiRes Software version 2.3.0, please refer to
the Cedex HiRes Analyzer Operator’s Manual, Software Version 2.3.
Information About Cedex HiRes Software Version 2.3.4
5
Software Version 2.3.2
Updating from Cedex HiRes Software Version 2.3.2 or 2.3.3
to Cedex HiRes Software Version 2.3.4
The procedure described in this chapter applies only for updating from Cedex HiRes Software version 2.3.2
or 2.3.3 to version 2.3.4.
c For details about installing or updating to Cedex HiRes Software version 2.3.2, please refer to Section B,
“Updating to Cedex HiRes Software 2.3.2 or Installing the Cedex HiRes Software 2.3.2”, in the Cedex
HiRes Analyzer Operator’s Guide, Software Version 2.3.2.
Before starting an update of your current Cedex HiRes Software to Cedex HiRes Software version 2.3.4, ensure
that:
c You have Cedex HiRes Software version 2.3.2 or 2.3.3 installed on your system, and you have the required
software package for updating to Cedex HiRes Software version 2.3.4. Consult with your local Roche
Technical Service in case of questions.
c You have administrator access to the Control Unit.
c A storage device with enough disk space is available for a backup of the current installation. Check the size
of the folder containing all Cedex HiRes Software 2 files, including the database file (usually the directory
C:\Cedex2). The size of the backup will be approximately the size of this folder.
c Enough time is scheduled for a backup of the current installation (approximately one hour for backup to a
fast external hard drive per 10 GB disk space used in the Cedex2 directory, including the database file).
Before performing any form of installation or update procedure, the actual (effective) values for the
FlowFactor and ChamberHeight must be saved and stored for future reference. These values may need
to be adjusted in the System Options after the installation or update procedure is complete. The value for
FlowFactor is located in the System Options menu under the General tab. The value for the ChamberHeight
is located in the System Options menu under the Hardware tab. See “System Options and User Preferences”
in the Appendix for more information.
Before updating the software, ensure that you have created a backup of the Cedex HiRes Software database
in a remote, secure storage device that is not part of the Control Unit. Also, ensure that you fully read and
understand the following instructions before proceeding with the update of the Cedex HiRes Software. If an
error occurs or if you do something incorrectly, this could result in data loss and/or could prevent the Cedex
HiRes Software from operating.
If the Cedex HiRes Software version 2.3.2 or 2.3.3 is not yet installed on your Control Unit, please refer to
Section B, “Updating to Cedex HiRes Software 2.3.2 or Installing the Cedex HiRes Software 2.3.2”, in the
Cedex HiRes Analyzer Operator’s Guide for information updating to Cedex HiRes Software 2.3.2.
Updating from Cedex HiRes Software Version 2.3.2 or 2.3.3 to Cedex HiRes Software Version 2.3.4
6
Cedex HiRes Analyzer Addendum 5 to Operator’s Guide, Version 3.0
To update from Cedex HiRes Software Version 2.3.2 or 2.3.3 to Cedex HiRes Software version
2.3.4, do the following:
1
Place the folder containing the Cedex Software version 2.3.4 update on the Control Unit, and double-click on
the Cedex Setup 2.3.4.exe program.
2
Click on Install.
Figure 1
If a window appears asking for administrator confirmation, click ‘Yes’ and continue with the
installation.
3
Click on Next.
Figure 2
4
Put a checkmark in the box “I accept the terms in the License Agreement” and click on Next.
Figure 3
ccc
Updating from Cedex HiRes Software Version 2.3.2 or 2.3.3 to Cedex HiRes Software Version 2.3.4
7
Software Version 2.3.2
5
Click on Next to install the Cedex Software files into the recommended folder (C:\Cedex2).
Figure 4
6
Click on Install to initiate the installation.
Figure 5
7
The installation will begin.
Figure 6
8
When the following dialog box appears, click on Finish.
Figure 7
ccc
Updating from Cedex HiRes Software Version 2.3.2 or 2.3.3 to Cedex HiRes Software Version 2.3.4
8
Cedex HiRes Analyzer Addendum 5 to Operator’s Guide, Version 3.0
9
The Setup Successful dialog box will appear if the installation was completed successfully.
Confirm with OK.
Figure 8
■
Cedex Software 2.3.4 is now installed.
Updating from Cedex HiRes Software Version 2.3.2 or 2.3.3 to Cedex HiRes Software Version 2.3.4
9
Software Version 2.3.2
Chapter D Maintenance and Care
Please read the following additional maintenance information for the Cedex HiRes Operator’s Manual,
software version 2.3.2.
Exchanging the fuse in Cedex HiRes Analyzers from serial number G037DA101
Cedex HiRes Analyzers from serial number G037DA101 contain a fuse that must be exchanged when the fuse is
blown. The Cedex HiRes Analyzer delivery package includes a set of 10 replacement fuses.
Before inspecting or replacing the fuse, the power cord must be disconnected entirely from the power supply.
1
Turn off the analyzer and disconnect the power cord from the power supply.
2
The fuse is located at the back of the analyzer.
3
Remove the fuse holder from the instrument by turning the fuse holder cap counter-clockwise.
4
Remove the blown out fuse and insert the new fuse into the fuse holder cap.
Use only the fuses provided with the analyzer! See information about the fuses, below.
ccc
Chapter D
Maintenance and Care
10
Cedex HiRes Analyzer Addendum 5 to Operator’s Guide, Version 3.0
5
Slide the fuse holder back into position, and tighten it by turning the fuse holder cap clockwise.
6
Reconnect the power cord to the power supply, and turn on the instrument.
■
If the replacement fuse is immediately blown, contact your local Roche Technical Support.
Information about fuses delivered with Cedex HiRes Analyzers from serial number G037DA101:
26213047001 FUSE 5x20 2.5AT H 250V ULL/CSA Package Content Quantity: 10 pcs.
Chapter D
Maintenance and Care
Published by
Roche Diagnostics GmbH
Sandhofer Strasse 116
68305 Mannheim
Germany
© 2016 Roche Diagnostics.
All rights reserved.
www.custombiotech.roche.com
08028834001
1
062016
For use in quality control/manufacturing process only.
CEDEX is a trademark of Roche.
All other product names and trademarks are
the property of their respective owners.
/