EN 60601-1-2 Immunity tests
Immunity test Test level
Compliance level
Reached
Electrostatic
discharge
(ESD)
EN 61000-4-2
Contact: ± 8 kV
Air: ± 2 kV,± 4 kV,
± 8kV,± 15 kV
Contact: ± 8 kV
Air: ± 2 kV,± 4 kV,
± 8kV,± 15 kV
Radiated RF
EN 61000-4-3
3 V/m
80MHz to 2700MHz
3 V/m
80MHz to 2700 MHz
Proximity
elds from RF
devices
EN 61000-4-3
9 to 28V/m
385 to 5785MHz
As per Table 9
EN60601-1-2:2015
9 to 28V/m
385 to 5785MHz
As per Table 9
EN60601-1-2:2015
Medical Devices may be affected by mobile RF communications
equipment including cellular telephones and other personal
or household devices not intended for medical facilities. It is
recommended that all equipment used near the Vitalograph product
comply with the medical electromagnetic compatibility standard
and to check before use that no interference is evident or possible.
If interference is suspected or possible, switching off the offending
device is the normal solution, as is required in aircraft and medical
facilities.
Medical electrical equipment needs special precautions regarding
EMC and needs to be installed and put into service according to the
EMC information provided.
15. FDA Notice
Caution: Federal Law restricts this device to sale by, or on the order
of a physician.
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