Roche Cedex HiRes User manual

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

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

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.

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Roche Cedex HiRes User manual

Roche Cedex HiRes User manual

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