Roche Cedex Bio HT User manual



Cedex Bio HT Analyzer Operator’s Manual



Software Version 5.0 November 2020



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.

Revisions

J

Use this section of the manual as a repository for updates to the Cedex

Bio HT Analyzer User 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.

J

Cedex Bio HT Analyzer Revisions

User Manual · Version 1.3.1 J-3

Revisions

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

and the Cedex Bio HT Analyzer User Training Guide.

In this chapter

Chapter

22

Revision version 1.0

Changes in Ce

dex Bio HT Analyzer Guides ..................................................................... J-5

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

Change 1: Approvals apply to more recent directives. ............................................ J-7

Change 2: Approvals apply to more recent directives. ............................................ J-8

Change 3: The text concerning FCC compliance and radio frequency energy 

has been replaced. The information regarding the uninterrruptible power 

supply has been replaced and expanded. ................................................................... J-9

Change 4: Safety labels on the analyzer changed.................................................... J-11

Change 5: Information on connecting a printer was added.................................. J-12

Change 6: Information on printer connectors and on PCL 5 compliance 

was added. .................................................................................................................... J-13

Change 7: Information on PCL 5 compliance was added. .................................... J-14

Change 8: The mains power supply connector is no longer used. ....................... J-15

Change 9: Information on possible printer connectors and on PCL 5 

compliance was added ................................................................................................ J-16

Change 10: Rack positions cannot be changed when the ISE rack is on board.. J-17

Change 11: Information on PCL 5 compliance was added. .................................. J-18

Change 12: Information on PCL 5 compliance of the printer was added 

and that the USB connector is intended for connection to a printer................... J-19

Revision version 2.0

Change 13: The compliance informatio

n for fluorinated greenhouse gas 

was added. .................................................................................................................... J-20

Change 14: Further approvals apply to more recent directives. ........................... J-21

Change 15: Further approvals apply to more recent directives. ........................... J-22

J-4 User Manual · Version 1.3.1

Revisions Cedex Bio HT Analyzer

Revision version 3.0

Change 16: Changing password after initial installation....................................... J-23

Change 17: Warning statement added to inform about flammable refrigerant. J-24

Change 18: Caution statement added to inform about sharps, rough edges, 

and/or moving parts ................................................................................................... J-25

Change 19: Section “Software virus warning” was replaced with 

new section “Software and data security”................................................................ J-26

Change 20: Information added about two new safety labels on 

the system informing about flammable refrigerant ............................................... J-29

Change 21: Tip added to advice the user that the system must be in 

Standby state when creating a problem report ....................................................... J-30

Change 22: Tip added to advice the user that the system must be in 

Standby state when creating a problem report ....................................................... J-31

Change 23: The water purity must have a maximum microbiological 

content of 100 colony forming units per mililiter .................................................. J-33

Change 24: Information about water quality changed .......................................... J-34

2322

J

Cedex Bio HT Analyzer Revisions

Changes in Cedex Bio HT Analyzer Guides

User Manual · Version 1.3.1 J-5

Changes in Cedex Bio HT Analyzer Guides

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 

User Training Guide

1.1 5.0 1.0 December 2015

Cedex Bio HT Analyzer

Operator’s Manual

1.3 5.0 1.0 December 2015

Cedex Bio HT Analyzer 

User Training Guide

1.1 5.0 2.0 December 2016

Cedex Bio HT Analyzer

Operator’s Manual

1.3 5.0 2.0 December 2016

Cedex Bio HT Analyzer 

User Training Guide

1.1.1 5.0 3.0 November 2020

Cedex Bio HT Analyzer

Operator’s Manual

1.3.1 5.0 3.0 November 2020

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

can easily insert them in the existing manual.

J-6 User Manual · Version 1.3.1

Revisions Cedex Bio HT Analyzer

Changes in Cedex Bio HT Analyzer Guides

Structure of a change entry

The following illustration explains how changes are presented.

Revisions Cedex Bio HT Analyzer

Changes in Cedex Bio HT Analyzer Guides

Change 6 Section “Software virus warning” was replaced with new section

“Software and data security”

Affected page: xix

Software and data security

Revision: Section “Software virus warning” was replaced with “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 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.

A

B

C

D

E

A Change ID.

B Change summary.

C Page that is 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 Revisions

Changes in Cedex Bio HT Analyzer Guides

User Manual · Version 1.3.1 J-7

Change 1 Approvals apply to more recent directives.

Affected page: User Training Guide, page 4

Instrument approvals The Cedex Bio HT Analyzer meets the protection requirements laid down in:

Revision: Text adjusted to reflect latest regulations

o Council Directive 2014/30/EU on the alignment of the legal provisions of the

Member States on electromagnetic compatibility (EMC).

o Council Directive 2014/35/EU on the alignment of the legal provisions of the

Member States on electrical equipment for use within certain voltage limits.

Compliance is provided by means of the Declaration of Conformity.

Regulatory compliance is demonstrated by the following marks:

Revision: Text adjusted to reflect latest regulations

Complies with European Union (EU) Directives 2014/30/EU and

2014/35/EU.

Issued by Underwriters Laboratories, Inc. (UL) for Canada and the

US.

CUS

®

J-8 User Manual · Version 1.3.1

Revisions Cedex Bio HT Analyzer

Changes in Cedex Bio HT Analyzer Guides

Change 2 Approvals apply to more recent directives.

Affected page: Operator’s Manual, page ii

Instrument approvals The Cedex Bio HT Analyzer meets the protection requirements laid down in:

Revision: Text adjusted to reflect latest regulations

o Council Directive 2014/30/EU on the alignment of the legal provisions of the

Member States on electromagnetic compatibility (EMC).

o Council Directive 2014/35/EU on the alignment of the legal provisions of the

Member States on electrical equipment for use within certain voltage limits.

Compliance is provided by means of the Declaration of Conformity.

Regulatory compliance is demonstrated by the following marks:

Revision: Text adjusted to reflect latest regulations

Complies with European Union (EU) Directives 2014/30/EU and

2014/35/EU.

RoHS compliant from Serial No. 610001.

Issued by Underwriters Laboratories, Inc. (UL) for Canada and the

US.

CUS

®

Cedex Bio HT Analyzer Revisions

Changes in Cedex Bio HT Analyzer Guides

User Manual · Version 1.3.1 J-9

Change 3 The text concerning FCC compliance and radio frequency energy has

been replaced. The information regarding the uninterrruptible power

supply has been replaced and expanded.

Affected page: Operator’s Manual, page xvii

The electromagnetic environment should be evaluated prior to operation of the device.

Revision: Text adjusted and expanded to reflect latest regulations

US Federal Communications Commission: This equipment has been tested and found

to comply with the limits for a Class A digital device, pursuant to part 15 of the FCC

Rules. These limits are designed to provide reasonable protection against harmful

interference when the equipment is operated in a commercial environment.

This equipment generates, uses, and can radiate radio frequency energy and, if not

in

stalled and used in accordance with the instruction manual, may cause harmful

interference to radio communications. Operation of this equipment in a residential

area is likely to cause harmful interference in which case the user will be required to

correct the interference at his own expense.

International Special Committee on Radio Interference (CISPR): This system is

d

esigned and tested to CISPR 11 Class A standard. In a domestic environment it may

cause radio interference, in which case, you may need to take measures to mitigate the

interference.

Uninterruptible power supply (UPS)

Revision: Text rephrased to reflect IEC 61000-4-11 requirements

The Cedex Bio HT Analyzer does not fully comply with IEC 61000-4-11:

If there is a power loss on one sinus period, the Ce

dex Bio HT Analyzer can not cope

with this situation and will stop. If the above norm must comply fully, the installation

of a UPS is necessary.

Also if the main power supply is unstable or unreliable, an uninterruptible power

su

pply (UPS) should be installed.

Revision: New tip

When you intend to use a UPS, make sure to connect not only the Cedex Bio HT Analyzer but

also its data station (control unit).

J-10 User Manual · Version 1.3.1

Revisions Cedex Bio HT Analyzer

Changes in Cedex Bio HT Analyzer Guides

Revision: New information on UPS requirements

Roche does not recommend a specific type of UPS, but the following requirements

should be met when choosing a UPS:

o Switch over time < 10 ms

o Runtime without external power > 15 min

For questions regarding the UPS contact your Roche Service representative.

Cedex Bio HT Analyzer Revisions

Changes in Cedex Bio HT Analyzer Guides

User Manual · Version 1.3.1 J-11

Change 4 Safety labels on the analyzer changed.

Affected page: Operator’s Manual, page xx

Safety label on analyzer Location and meaning

Laser transmitter warning

Situated inside of the rack access panel

to

designate the presence of a laser

transmitter. Do not stare into the laser

transmitter.

Laser transmitter warning

Situated outside of the rack access panel

to

designate the presence of a laser

transmitter. Do not stare into the laser

transmitter.

Revision: Different labels

J-12 User Manual · Version 1.3.1

Revisions Cedex Bio HT Analyzer

Changes in Cedex Bio HT Analyzer Guides

Change 5 Information on connecting a printer was added

Affected page: Operator’s Manual, page A-6

User interface You can control the user interface with the mouse and keyboard. The user interface is

structured as a series of work areas; the main ones are Status, Orders, Results, and

Service. Each work area contains two or more tabs. By clicking a tab, you can move

around the work area.

Revision: Printer must be PCL 5 compliant

You can display any test results on the monitor or print reports containing

information on orders and results. Connection to a local printer is optional. This

printer needs to be PCL

5 compliant, and can be connected using either LPT or a USB

port.

You can manually enter orders for tests in the Orders work area. Alternatively, the

system receives orders electronically from a host system, if your Cedex Bio HT

Analyzer is connected to such a system.

System messages are displayed in the Messages work area, and you can communicate

with other users by using the Memo Pad.

Cedex Bio HT Analyzer Revisions

Changes in Cedex Bio HT Analyzer Guides

User Manual · Version 1.3.1 J-13

Change 6 Information on printer connectors and on PCL 5 compliance was

added.

Affected page: Operator’s Manual, page B-41

What if?

I put the rack back in

another slot

If you insert the rack into another slot, the system will identify the rack and the slot.

I cannot print the worklist

or loadlist

Revision: Printer can be connected to LPT or USB port

Check whether the printer is connected (using either LPT or a USB port), switched on,

and whether there is a supply of paper in the printer. Make sure you have the user

access level for printing (Configuration / General / User Level).

Revision: Printer must be PCL 5 compliant

If a new printer was installed for your system, ask your system administrator to check

whether the appropriate Windows XP printer driver is installed. (Other drivers will

not work on Windows XP.) Ensure that the printer is also PCL

5 compliant.

J-14 User Manual · Version 1.3.1

Revisions Cedex Bio HT Analyzer

Changes in Cedex Bio HT Analyzer Guides

Change 7 Information on PCL 5 compliance was added.

Affected page: Operator’s Manual, page E-35

Printer

a Printer connections and printer indicators OK, but still no printout

1 Check the printer settings in Windows XP.

Revision: Printer must be PCL 5 compliant

2 Check that the printer driver, currently used as the default, corresponds to the

printer actually connected. (This printer needs to be PCL

5 compliant.) Modify

the printer settings, if necessary.

Cedex Bio HT Analyzer Revisions

Changes in Cedex Bio HT Analyzer Guides

User Manual · Version 1.3.1 J-15

Change 8 The mains power supply connector is no longer used.

Affected page: Operator’s Manual, page E-37

Waste, water, and power connectors

The waste, water, and power connectors are located at the back of instrument.

ACDE FGB

A Mains input connector

Revision: Do not use the mains supply connector (B)

B Mains supply connector, not used

C Water reservoir level sensor

D Not used

E Waste reservoir level sensor

F Water reservoir connector

G Waste reservoir connector

J-16 User Manual · Version 1.3.1

Revisions Cedex Bio HT Analyzer

Changes in Cedex Bio HT Analyzer Guides

Change 9 Information on possible printer connectors and on PCL 5 compliance

was added

Affected page: Operator’s Manual, page E-39

Revision: Printer must be PCL 5 compliant

Printer connections

(optional)

o Ensure that the printer is PCL 5 compliant.

Revision: Text on connection adjusted

o Check that the printer cable is connected to the control unit.

o Check that the printer power cable is properly connected at both ends.

Cedex Bio HT Analyzer Revisions

Changes in Cedex Bio HT Analyzer Guides

User Manual · Version 1.3.1 J-17

Change 10 Rack positions cannot be changed when the ISE rack is on board.

Affected page: Operator’s Manual, page F-33

The electromagnetic environment should be evaluated prior to operation of the device.

Tips

o The positions of solutions on the ISE rack are user defined. To check the actual

positions, as defined for your system, use the ISE tab in the Status work area.

Revision: Information added that you can only change the rack position when the ISE rack is not on board (not

locked)

o You can change the rack positions for the ISE Solutions. The ISE rack shows a

"lock" symbol when it is on board. When it is locked, the positions cannot be

changed. The rack must first be removed, and then the predefined positions can be

changed using Configuration / Lab / Reserve Positions.

J-18 User Manual · Version 1.3.1

Revisions Cedex Bio HT Analyzer

Changes in Cedex Bio HT Analyzer Guides

Change 11 Information on PCL 5 compliance was added.

Affected page: Operator’s Manual, page G-22

Revision: Printer must be PCL 5 compliant

Windows group

Printers Double-click the Printers icon to review or modify the choice of printer and printer

settings. Ensure that the printer is PCL

5 compliant.

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Roche Cedex Bio HT User manual

Roche Cedex Bio HT User manual

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