Roche Cedex Bio HT User manual

Type
User manual
Cedex Bio HT Analyzer Operator’s Manual
Software Version 5.1 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.
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
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
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:
>0.6Mcm 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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Roche Cedex Bio HT User manual

Type
User manual

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