User Manual
Diffustik
DIFFUSTIK_MAN_ENG_V1.2.2_REV01.DOCX
Page 13
In addition the following norms are fulfilled:
- DIN EN 60601-1 (Medical electrical device)
- DIN EN 60601-1-1 (General safety requirements)
- DIN EN 60601-1-2 (EMV)
- DIN EN 60601-1-4 (Programmable electrical medical devices)
- DIN EN ISO 14971 (Risk management)
- DIN EN ISO 23747 (Peak Flow devices)
2.3.1.2
Electromagnetic compatibility
Strong radio transmitters should not be used close to the device.
Do not use mobile phones and cordless phones close to the device.
There may be an influence to medical devices.
The interference resistance is 3V/m. Do not use a higher level close to
the Diffustik.
2.3.2
Secure use of Diffustik
The Diffustik is a medical device to perform CO-Diffusion tests. It is
highly recommend that the user observes all warning notices in order to
ensure a safe use of the device. Following parts of the measurement
system are usable in the patient environment:
-
Medical cart
-
Electric unit
-
Shutter unit
-
Demand valve and gas analyzer
Equipment which is not part of the measurement
system described above, should not be connected.
Only the mentioned devices should be connected to the
described signal connections.
