Not For Use In Areas Of Explosion Hazard Or Oxygen-Enriched Atmospheres; Connected Devices; Safe Connection With Other Electrical Equipment; Connection To It Network - Dräger Infinity Acute Care System Instructions For Use Manual

Not for use in areas of explosion hazard
or oxygen-enriched atmospheres
WARNING
Risk of fire
The medical device is not approved for use in
areas where combustible or explosive gas
mixtures are likely to occur or in oxygen-
enriched atmospheres.

Connected devices

WARNING
Risk of electric shock and of device failure
Any connected devices or device combina-
tions not complying with the requirements
mentioned in these instructions for use may
compromise the correct functioning of the
medical device. Before operating any combi-
nation of devices, refer to and strictly comply
with the instructions for use for all connected
devices and device combinations.
Safe connection with other electrical
equipment
CAUTION
Risk of patient injury
Electrical connections to equipment not listed in
these instructions for use must only be made
when approved by each respective manufacturer.

Connection to IT network

The medical device has interfaces to connect to
other devices or components. These interfaces are
only suitable for connecting devices or connecting
to networks that have the physical characteristics
described on page 11 and page 50.
Instructions for use - Infinity ® Acute Care System - Infinity
For your safety and that of your patients
For software-related requirements on the
connection of devices or networks to these
interfaces observe the relevant documents of these
applications.
If the Cockpit is used to send or distribute alarm
conditions to another device and that system is not
able to be a "distributed alarm system with
confirmed delivery of alarm conditions" as per IEC
60601-1-8:2006 +A1:2012, cl. 6.11.2.2, then the
corresponding remote part of the system shall be
labeled with a warning that it shall not be relied
upon for receipt of alarm signals.

Device combinations

This device can be operated in combination with
other Dräger devices or with devices from other
manufacturers. Observe the accompanying
documents of the individual devices.
If a device combination is not approved by Dräger,
the safety and the functional state of the individual
devices can be compromised. The operating
organization must ensure that the device
combination complies with the applicable editions
of the relevant standards for medical devices.
Device combinations approved by Dräger meet the
requirements of the following standards (if
applicable):
– IEC 60601-1, 3rd edition (general requirements
for safety, device combinations, software con-
trolled functions)
– IEC 60601-1-2 (electromagnetic compatibil-
ity)
– IEC 60601-1-8 (alarm systems)
Strictly follow the assembly instructions and
instructions for use.
The Infinity Acute Care System -
Infinity Medical Cockpits have no essential
performance as defined in IEC 60601-1.
® Medical Cockpits 9