Vitalograph micro 6300 - FDA Notice

ENG
37Page of 44
09360 Issue 2
Vitalograph micro - Instructions for Use
PowerFrequency
Magnetic Field
Immunity
EN 61000-4-8
30A/m 30A/m
Power Magnetic Field
Immunity
EN 61000-4-8
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Vitalographproduct
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
verication.Referencesection5.4ofthisdocumentfordetailson
completingacalibrationvericationonthemicro.
If interference is suspected or possible, move the micro to a new
locationandrepeatthecalibrationverication.
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 6300 micro is a Spirometer and so the performance
deemedtobeessentialistheoutputoftheowtransducer
WARNING: No modication of this equipment is allowed.
16. FDA Notice
Caution: Federal Law restricts this device to sale by, or on the order
of a physician.