Instructions for use Perseus A500 SW 2.0n 255
Technical data
The documents are only available in English.
The following personal data are transmitted
unencrypted over the interface:
– Therapy data with details of age, weight, and
height of the patient
With the aim of improving the clinical process, the
data can be used to construct a distributed alarm
system with unacknowledged alarm transmission
conforming to IEC 60601-1-8. However, the data
must not be used as a substitute for Perseus as
the primary alarm source.
Alarm conditions are only transmitted in the
network if they are present at the time of an active
query by a connected device. An alarm history is
not transmitted.
Note: Each connected device within the distributed
alarm system must be marked with the following
warning: No guaranteed reception of alarm
signals.
Required characteristics
The RS232 interface is a point-to-point connection.
A connected device must prevent access by
unauthorized users to the data that are sent over
the RS232 interface and must itself be protected
from infections by malware and computer viruses.
USB interface
The USB interface supports the transfer of data to
external storage media. Existing data on external
storage media can be deleted during this
operation.
The following personal data are transmitted
unencrypted over the interface:
– User logbook with details of age, weight, and
height of the patient
– Screenshots potentially showing information
about the age, weight, and height of the patient
Required characteristics
A connected device must conform to the mass
storage medium USB device class (e.g.,
connecting devices to charge the battery is not
intended.). Dräger recommends the use of
FIPS 140-2 compatible storage media with
hardware encryption.
Hazardous situations
Connecting active devices to the Perseus USB
interface can cause Perseus to restart.
WARNING
Risk due to incompletely transferred data
Data (e.g., measured values, alarms) which
the anesthesia machine transfers to other
systems such as patient monitors or EMR
systems may be displayed there incompletely
or incorrectly.
– Only use these data for information
purposes.
– Do not use these data for patient
monitoring or device monitoring.
– Do not make diagnostic or therapeutic
decisions on the basis of these data.
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