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.