Roche Cedex Bio HT User manual

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Cedex Bio HT Analyzer Operator’s Manual



Software Version 5.1 November 2020

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For use in quality control/manufacturing process only.

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How to Use the Cedex Bio HT Analyzer Guides

Before reading, please review the section "Revisions" for

important information.

User Training Guide

Provides detailed step-by-step instructions for routine operation using the main applications of

the Cedex Bio HT Analyzer, including instrument startup and shutdown.

Operator´s Guide

Provides a detailed description of the Cedex Bio HT Analyzer, system components and all

relevant 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 Bio HT Analyzer Guides, including new supplementary information

and corrections to previous editions.

Use this section of the manual as a repository for

updates to the Cedex Bio HT Analyzer Operator’s

Manual. You can also use this section to insert your

own notes about the system, so that all information

about the system is in one place.

Revisions

J

Roche Diagnostics

Operator’s Manual · Version 1.4.1 J-3

Cedex Bio HT Analyzer 21 Revisions

Table of contents

Revisions

This chapter contains amendments to the Cedex Bio HT Analyzer Operator’s Manual and

the Cedex Bio HT Analyzer User Training Guide.

Changes in Cedex Bio HT Analyzer Guides 1.4 .............................................................J-5

Structure of a change entry .........................................................................................J-6

Change 1: Changing password after initial installation ..........................................J-7

Change 2: Warning statement added to inform about flammable refrigerant ...J-8

Change 3: Caution statement added to inform about sharps, rough edges, and/or

moving parts .................................................................................................................J-9

Change 4: Safety statement about software and data security updated ..............J-10

Change 5: Information added about two new safety labels on the system informing

about flammable refrigerant .....................................................................................J-13

Change 6: Label position of the two new safety labels added ..............................J-14

Change 7: The water purity must have a maximum microbiological content of

100 colony forming units per mililiter ....................................................................J-15

Change 8: Information about water quality changed ...........................................J-16

Change 9: Information about Importing orders using Excel added ................J-17

Change 10: Tip added to advise the user that the system must be in Standby state

when creating a problem report ...............................................................................J-19

Change 11: Tip added to advise the user that the system must be in Standby state

when creating a problem report ...............................................................................J-21

Change 12: Language parameter

A system restart is required after changing the language of the software ..........J-23

In this chapter

Chapter

21

Roche Diagnostics

Operator’s Manual · Version 1.4.1 J-5

Cedex Bio HT Analyzer 21 Revisions

Changes in Cedex Bio HT Analyzer Guides 1.4

In order to ensure that the readers of the Cedex Bio HT Analyzer User Manual use

the up-to-date content, Roche recommends to manually mark the affected passage in

the original manual.

a To update the Cedex Bio HT Analyzer User Guides

1

In the current chapter Revisions, go to the first change.

2

Familiarize yourself with the items that changed.

3

Identify the page number affected in the original manual.

4

Go to the appropriate page in the original and manually mark the changes. For

example cross out text that is no longer applicable or add a reference where to

find new and changed content.

Manual Manual Version Software Version Revision Chapter Version Revision Date

Cedex Bio HT Analyzer

Operator’s Manual

1.4.1 5.1 1.0 November 2020

Cedex Bio HT Analyzer User

Training Guide

1.3.1 5.1 1.0 November 2020

If you print these pages, Roche recommends printing them single-sided. This way you can

easily insert them in the existing manual.

Roche Diagnostics

J-6 Operator’s Manual · Version 1.4.1

21 Revisions Cedex Bio HT Analyzer

Changes in Cedex Bio HT Analyzer Guides 1.4

Structure of a change entry

The following illustration explains how changes are presented.

A Change ID.

B Change summary.

C Pages that are affected in the

manual.

D An indication of the nature of the change immediately

precedes the changed or new element(s).

E Changed element(s).

Cedex Bio HT Analyzer

Change 6 Safety statement about software and data security updated

Affected pages: 28-29

Software and data security

Revision: Safety statement about software and data security updated (several changes)

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 is not protected against malicious software and hacker attacks.

o Physical access to the product and all attached IT infrastructure (including

analyzer, computer systems, cables, network equipment, etc.) must be restricted

at all times.

o A Roche-provided firewall is mandatory if the system is connected to a network

to protect and separate Roche systems from other laboratory infrastructure.

o The laboratory network and any laboratory infrastructure must be secured

against unauthorized access, malicious software, and cyber-attacks.

o All devices and services used in the customer lab infrastructure must be safe and

secured against malicious software and unauthorized access.

o A secure network environment which is resilient to traffic redirection and

eavesdropping must be installed.

Roche recommends the following precautions:

o Do not copy or install any software on the system unless it is part of the system

A

B

D

E

C

Roche Diagnostics

Operator’s Manual · Version 1.4.1 J-7

Cedex Bio HT Analyzer 21 Revisions

Changes in Cedex Bio HT Analyzer Guides 1.4

Change 1 Changing password after initial installation

Affected page: Operator’s Manual, page 10

Revision: New security statement added

For security reasons, the administrator should protect the access to the Cedex Bio HT

Software with a new password after initial installation.

e

For details, see Cedex Bio HT Analyzer Operator's Manual “Assigning and deleting user

details”.

Roche Diagnostics

J-8 Operator’s Manual · Version 1.4.1

21 Revisions Cedex Bio HT Analyzer

Changes in Cedex Bio HT Analyzer Guides 1.4

Change 2 Warning statement added to inform about flammable refrigerant

Affected page: Operator’s Manual, page 23

Cauterizing and toxic materials

Reagents and toxic chemicals Contact with cauterizing or toxic material may result in injury.

o Follow standard laboratory practices.

o Wear appropriate personal protective equipment.

o If cauterizing or toxic material is spilled, wipe it up immediately and apply a

disinfectant.

o If cauterizing or toxic material comes into contact with your skin, wash the

affected area immediately with soap and water and apply a disinfectant. Consult a

physician.

Flammable materials

Revision: New warning statement added

Flammable refrigerant There is a risk of fire or explosion due to the use of flammable refrigerant.

o All ventilation openings must be clear of obstructions.

o Do not use mechanical devices or other means to accelerate the defrosting process

other than the ones recommended by the manufacturer.

o Do not damage the refrigerant circuit.

o Dispose of properly in accordance with federal or local regulations.

Roche Diagnostics

Operator’s Manual · Version 1.4.1 J-9

Cedex Bio HT Analyzer 21 Revisions

Changes in Cedex Bio HT Analyzer Guides 1.4

Change 3 Caution statement added to inform about sharps, rough edges, and/or moving

parts

Affected page: Operator’s Manual, page 25

Mechanical safety

Personal injury and infection

due to sharps, rough edges,

and/or moving parts

Revision: New caution statement added

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.

Roche Diagnostics

J-10 Operator’s Manual · Version 1.4.1

21 Revisions Cedex Bio HT Analyzer

Changes in Cedex Bio HT Analyzer Guides 1.4

Change 4 Safety statement about software and data security updated

Affected pages: Operator’s Manual, page 28-29

Software and data security

Revision: Safety statement about software and data security updated (several changes)

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 is not protected against malicious software and hacker attacks.

o Physical access to the product and all attached IT infrastructure (including

analyzer, computer systems, cables, network equipment, etc.) must be restricted

at all times.

o A Roche-provided firewall is mandatory if the system is connected to a network

to protect and separate Roche systems from other laboratory infrastructure.

o The laboratory network and any laboratory infrastructure must be secured

against unauthorized access, malicious software, and cyber-attacks.

o All devices and services used in the customer lab infrastructure must be safe and

secured against malicious software and unauthorized access.

o A secure network environment which is resilient to traffic redirection and

eavesdropping must be installed.

Roche recommends the following precautions:

o 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.

o If extra software is required, contact your Roche representative to ensure

validation of the software in question.

o Do not use the USB ports to connect other storage devices unless your Roche

representative or an operating instruction tells you to do so.

o Exercise care when you use external storage devices such as USB drives or DVDs.

Do not connect to the system any external storage device that you use on public

or home computers.

o Keep all external storage devices in a secure place, and make sure that only

authorized personnel can access them.

o Back up your data regularly.

Cybersecurity and privacy

awareness

o Perform regular security and privacy awareness trainings 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.

o Check your analyzer for suspicious activity and report any suspected compromise

immediately to your local Roche representative.

o Update to latest software versions provided by Roche as soon as possible.

o Read and follow the recommendations and advices written in this chapter.

Roche Diagnostics

Operator’s Manual · Version 1.4.1 J-11

Cedex Bio HT Analyzer 21 Revisions

Changes in Cedex Bio HT Analyzer Guides 1.4

Backup security The following precautions are mandatory:

o Only use virus free external storage devices for backup purposes.

o Transmit backup data to external storage devices via secure networks only.

o Any data backup and data archive that has been exported from the analyzer must

be physically securely stored and protected from any unauthorized access.

o Data access to any data backup or data archive is permitted to authorized persons

only.

o Ensure that data backup and data archives are not taken from the safe and secure

storage location.

Data transfer and data entry on

analyzer

o 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.

o Do not download from any host system (e.g. LIS, middleware) any patient

sensitive data to the analyzer.

o 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

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.

o Always enter your password unobserved.

o Do not write down your password anywhere, including in a contact form, in the

address book, or in a file on the computer.

o Do not disclose your password to anyone. Roche will never ask you for your

password.

o Do not use shared accounts.

o If you ever disclose your password to anyone, change it immediately afterwards.

o Contact your local Roche affiliate if you think your account has been

compromised.

o Use a personal user account for each user with appropriate user level.

o Delete any unused user accounts from the analyzer (for example, when a user

left).

Corrupt data and unauthorized

access due to faulty media

converters

Media converters may influence the signal quality and corrupt data.

When using an RS232 to Ethernet media converter at the host interface, there is a

possibility of unauthorized access to and modification of the data that are transmitted

over the network.

Roche shall not be held liable for possible data corruption associated with media

converters.

Unreliable data due to low

quality connectors

Using cable connections to the host that are not well shielded may lead to absence or

instability of connection or to corrupt data.

o Always use well shielded RS232 cables for host connection.

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.

o Install only approved third-party software.

Cedex Bio HT Analyzer

Roche Diagnostics

J-12 Operator’s Manual · Version 1.4.1

Unreliable validation due to

unauthorized changes to the

validation settings

The manufacturer shall not be held liable for any consequences resulting from

subsequent, unauthorized modifications to the accepted validation settings included

in the system at the customer’s request.

o Ensure that only authorized personnel can change, if necessary, the validation

settings.

Unreliable validation due to

unauthorized changes to the

validation and calculation rules

The manufacturer shall not be held liable for any consequences resulting from

subsequent, unauthorized modifications to the accepted validation and calculation

rules included in the system at the customer’s request, as well as test results.

o Ensure that only authorized personnel can change, if necessary, the validation and

calculation rules, and test results.

Roche Diagnostics

Operator’s Manual · Version 1.4.1 J-13

Cedex Bio HT Analyzer 21 Revisions

Changes in Cedex Bio HT Analyzer Guides 1.4

Change 5 Information added about two new safety labels on the system informing about

flammable refrigerant

Affected page: Operator’s Manual, page 30

Revision: Information about two new safety labels on the system added

Biohazard

Potentially biohazardous materials are used near this label.

Observe relevant good laboratory practices on safe usage.

Flammable

There is a risk of fire or explosion near this label.

Flammable refrigerant in the cooling unit used.

Type of refrigerant R600a.

To be repaired only by trained service personnel. Do not puncture refrigerant tubing.

Consult Instruction Manual / Repair Manual / Owner’s Guide before attempting to install or

service this product. All safety precautions must be followed.

Dispose of properly in accordance with federal or local regulations.

Cedex Bio HT Analyzer

Roche Diagnostics

J-14 Operator’s Manual · Version 1.4.1

Change 6 Label position of the two new safety labels added

Affected page: Operator’s Manual, page 33

Revision: Indications of two new labels added

Figure 1 Labels on cuvette feeder and on the back of the instrument

CautionCaution

Refer to user manualRefer to user manual

AttentionAttention

Consultez le manuel dConsultez le manuel d©instructioninstruction

Fuse 3.2 AT

Supply 36V

Fuse 5AT

Fuse 3.2AT

Supply 100V

LED Supply FP

Fuse 2AT

Lamp Supply

ABS

Fuse 6.3AT

Fuse 3.2AT

24V Transfer Z

24V Resource Reagent

Fuse 3.2 AT

24V Resource Sample

Fuse 3.2 AT

24V Transfer XY/Cuvette

24V Measure

Fuse 3.2 AT

24V Analyzer/Fluid

5V

+15V

-15V

BIO HAZARD

W

ASTE CONT

AINER

I

LPT 1

HUB HUB

DS

Roche Diagnostics

Operator’s Manual · Version 1.4.1 J-15

Cedex Bio HT Analyzer 21 Revisions

Changes in Cedex Bio HT Analyzer Guides 1.4

Change 7 The water purity must have a maximum microbiological content of 100 colony

forming units per mililiter

Affected page: Operator’s Manual, page A-50

The water quality must fulfill the following requirements:

Purity

Revision: "type I NCCLS" removed

Laboratory Reagent Grade, bidistilled or deionized

water:

>0.6Mcm or <1.5 μS/cm

<0.05 Silicate (mg/L, as SiO

2

)

Revision: "10 colony forming units/mL" changed to

"100 colony forming units/mL"

Maximum microbiological content of 100 colony

forming units/mL. Particulate matter (>0.2 μm) <500/L.

Organic compound via activated carbon treatment.

Supply

From external reservoir or via direct connection to

deionized water supply (optional).

Usage/Drainage

Approximately 2 L/h (0.53 US gallon/h) in operating

mode

Minimum flow rate

0.2 L/min (0.053 US gallon/min)

Table A-27 Water quality requirements

Cedex Bio HT Analyzer

Roche Diagnostics

J-16 Operator’s Manual · Version 1.4.1

Change 8 Information about water quality changed

Affected pages: several pages in the Operator’s Manual

Revision: Information about water quality changed

In all relevant places in the Operator’s Manual, the statement "Water must be reagent

grade, type I." is replaced with "Use the water quality as specified in Table A-27 on

page A-50."

Roche Diagnostics

Operator’s Manual · Version 1.4.1 J-17

Cedex Bio HT Analyzer 21 Revisions

Changes in Cedex Bio HT Analyzer Guides 1.4

Change 9 Information about Importing orders using Excel added

Affected page: Operator’s Manual, page B-59

Importing orders using Excel

Revision: New section "Importing orders using Excel" added

Use the Import Orders from File function to conveniently import order data using

Excel files. To create an order import file, use the Excel template provided and adapt

the template with the required order information.

a To prepare the order import file

1

Copy the Excel template "OrderImport_ExampleTemp.xlsx" from the Cedex Bio

HT Analyzer control unit to a separate computer that has Excel installed. The

Excel template is located on the control unit on the C drive:

C:\Roche\Instrument\OrderImport

2

Open the template, add all sample and order information, and store the order

import file using a meaningful name.

When using the template, carefully read the template instructions provided in the

Excel file. Especially note the following:

o Do not change the column position or column number in the template.

o Row 10 is the first row that can be used to enter data. Do not insert rows

before row number 10.

o There are mandatory and optional fields. Do not leave mandatory fields

empty.

o Use only unique sample IDs. Ensure that sample IDs entered into the template

are not identical to any IDs on the order list.

o Ensure that all selected test and profile IDs refer to tests and profiles installed

on the system.

o Order date is automatically set to the current date.

3

Copy the order import file to the Cedex Bio HT Analyzer control unit to:

C:\Roche\Instrument\OrderImport.

o Use only the provided Excel template "OrderImport_ExampleTemp.xlsx" to create a new

order import file.

o Ensure that you are using the correct Excel template for software version 5.1.

Templates designed for software version 6.0 are not compatible with software version

5.1.

Cedex Bio HT Analyzer

Roche Diagnostics

J-18 Operator’s Manual · Version 1.4.1

a To load the order import file

1

On the Cedex Bio HT Analyzer control unit, choose Tools > Import Orders from

File.

A dialog box is displayed.

2

Load the order import Excel file that is located in

C:\Roche\Instrument\OrderImport.

The Import Orders from File dialog box is displayed, listing all orders from the

Excel file.

3

Check that all orders are OK and click Start.

The orders are imported. Successfully imported orders are marked in green.

4

If rows could not be imported, a dialog box is displayed indicating which order

rows not have been imported. Click OK to confirm the dialog box.

5

Create a new order import Excel file for the samples that not have been imported

and repeat steps 1 to 3.

It is possible to store the Excel file in other locations, such as an USB drive, and load the

file directly from the stored location.

Software 5.1 does not provide information about why ordered rows were not accepted.

Check carefully that all instructions have been followed. Ensure that the racks and rack

positions chosen for the samples are empty, and that the racks are not loaded and

locked on the instrument.

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