Dräger Babylog 8000 plus Instructions For Use Manual page 9

Not for use in areas of explosion hazard
WARNING
Risk of fire
The device is not approved for use in areas
where combustible or explosive gas mixtures
are likely to occur.
Connected devices
WARNING
Risk of electric shock and of device
malfunction
Electrical connections to equipment not
listed in these instructions for use or these
assembly instructions must only be made
when approved by each respective
manufacturer.
Before operating the medical device, strictly
comply with the instructions for use of all
connected devices or device combinations.
Instructions for use Babylog 8000 plus SW 5.n
For your safety and that of your patients
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:
– IEC 60601-1, 3rd edition (general requirements
for safety, device combinations, software-
controlled functions)
– IEC 60601-1-2 (electromagnetic
compatibility)
– IEC 60601-1-8 (alarm systems)
Or:
– IEC 60601-1, 2nd edition (general
requirements for safety)
– IEC 60601-1-1 (device combinations)
– IEC 60601-1-2 (electromagnetic
compatibility)
– IEC 60601-1-4 (software-controlled
functions)
– IEC 60601-1-8 (alarm systems)
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