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Cedex Bio HT Analyzer Operator’s Manual
Software Version 5.0 November 2020
For use in quality control/manufacturing process only.
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.
/
