Application
18 Instructions for use Fabius Tiro SW 3.n
Do not use Fabius in the following environments:
– Outside of massive buildings
– In intensive care units
– During patient transport
– In vehicles, airplanes, or helicopters
The MEDIBUS and Vitalink protocols
MEDIBUS and Vitalink are software protocols for
the transfer of data between Fabius and an
external medical or non-medical product (e.g.,
hemodynamic monitors, data management
systems, or Windows-based computers) via an
RS232 interface (see instructions for use 9038530,
3rd edition or higher).
The system must meet the requirements of
standards IEC 60601-1-1 and IEC 60601-1-2, or of
IEC 60601-1:2005 for medical electrical
equipment.
WARNING
Risk of device malfunctions and/or patient
injury and user injury
Magnetic fields can negatively influence the
correct functioning of the medical device and
therefore endanger the patient or user.
Do not use the medical device near magnetic
resonance imagers.
WARNING
Do not use soda lime based on potassium
hydroxide. Otherwise, there is a risk of CO
formation.
WARNING
Risk of patient injury
All data transferred via the MEDIBUS
interface are for information only and must
not be used as the sole basis for diagnostic
or therapeutic decisions. The data accessible
via this interface are not intended for use with
a distributed alarm system in accordance
with IEC 60601-1-8:2012 (in the sense of
remote monitoring).
WARNING
For the protection of patients and users from
electrical risk, it is required that all systems
that consist of medical devices and other
electrical devices, such as computers,
printers, etc., are assembled exclusively by
trained personnel.
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