Roche Diagnostics
A-10 Operator’s Manual, for the US · Version 1.0
1 General safety information cobas
®
4800 system
Disposal EGFR Mutation Test
Data security
Disposal
e
For information about disposal of the analyzer, refer to the Instrument Manual for the
cobas z 480 analyzer.
Unauthorized access and data loss due to malicious software and hacker attacks
Portable storage media can be infected with and transmit computer malware, which may
be used to gain unauthorized access to data or cause unwanted changes to software.
The cobas 4800 system is not protected against malicious software and hacker attacks.
The customers are responsible for IT security of their IT infrastructure and for protecting it
against malicious software and hacker attacks. Failure to do so may result in data loss or
render the cobas 4800 system unusable.
Roche recommends the following precautions:
o Allow connection to authorized external devices only.
o Ensure that all external devices are protected by appropriate security software.
o Ensure that access to all external devices is protected by appropriate security
equipment. cobas IT firewall must be used when the cobas 4800 system is integrated
into a network.
o Do not copy or install any software on the cobas 4800 software control unit unless it is
part of the system software or you are instructed to do so by a Roche Service
representative.
o If additional software is required, contact your Roche Service representative to ensure
validation of the software in question.
o Do not use the USB ports to connect other storage devices unless you are instructed to
do so by official user documentation or a Roche Service representative.
o Exercise utmost care when using external storage devices such as USB flash drives,
CDs, or DVDs. Do not use them on public or home computers while connecting to the
cobas 4800 system.
o Do not enter any confidential patient-relevant information into the work order file.
There is the risk of unauthorized access to patient data.
o Keep all external storage devices in a secure place and ensure that they can be
accessed by authorized persons only.
Disposal of control unit components
Components of your control unit (such as the computer, monitor, keyboard) which are
marked with this symbol are covered by the European Directive on Waste Electrical and
Electronic Equipment (WEEE, 2002/96/EC).
These items must be disposed of via designated collection facilities.
For more information about disposal of your old product, please contact your city office,
waste disposal service or your Roche representative.
Constraint: It is left to the responsible laboratory organization to determine whether control
unit components are contaminated or not. If contaminated, treat them in the same way as
the analyzer. For more information, refer to the analyzer’s instrument manual.
