28
Magnetic Field
Immunity
EN61000-4-8
Power Magnetic
Field Immunity
EN61000-4-8
8A/m 30kHz
65A/m 134.2 k Hz
(2.1 kHz PM)
7.5A/m 13.56 M Hz
(50 kHz PM)
8A/m 30kHz
65A/m 134.2 k Hz (2.1 kHz PM)
7.5A/m 13.56 M Hz (50 kHz PM)
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 Micro Spirometer comply with the medical
electromagnetic compatibility standard and to check before use that no
interference is evident or possible. Loss or degraded performance due to
EMI that exceeds the test levels in immunity test tables above will result
in a failed calibration verification on the Micro Spirometer. If interference
is suspected or possible, move the Micro Spirometer to a new location
and repeat the calibration verification.
Medical electrical equipment needs special precautions regarding EMC
and needs to be installed and put into service according to the EMC
information provided.
The Model MD6300 is a spirometer and so the performance deemed to
be essential is the output of the flow transducer.
WARNING: No modification of this equipment is allowed.
15. FDA Notice
Caution: Federal law restricts this device to sale by or on the order
of a physician.