59
IEC 60601-1-2: Table 204
Guidance and manufacturer’s declaration – electromag-
netic immunity
The device is intended for use in the electromagnetic environment specified
below. The customer or the user of the device should ensure that it is used
in such an environment.
Immunity
test
IEC 60601 test
level
Compliance
level
Electromagnetic environment -
guidance
Conduct-
ed RF IEC
61000-4-6
Radiated
RF
IEC
61000-4-3
3V(Vrms)
150kHz~80MHz
10V(engineering
medical
frequency
band)
150kHz~80MHz
10V/m
80MHz~2.5GHz
3V(Vrms)
10V
(engineering
medical
frequency
band)
10V/m
Portable and mobile RF communica-
tions equipment should be used no
closer to any part of the device, includ-
ing cables, than the recommended
separation distance calculated from the
equation applicable to the frequency of
the transmitter.
Recommended separation distance
d=1.2 √P
d=1.2 √P 80MHz~800MHz
d=2.3 √P 800MHz~2.5GHz
where P is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter manu-
facturer and d is the recommended
separation distance in metres (m).Field
strengths from fixed RF transmitters,
as determined by an electromagnetic
site surveya, should be less than the
compliance level in each frequency
rangeb.
Interference may occur in the vicinity of
equipment marked with the following
symbol:
Summary of Contents for AiDEX
Page 1: ...AiDEXTM Continuous Glucose Monitoring System User Guide MicroTech Medical Hangzhou Co Ltd...
Page 2: ......
Page 17: ...13 Sensor applicator Sensor base tape Glucose sensor Sterile packaging Sensor components...
Page 23: ...19...
Page 40: ...36 Enter the transmitter s serial number when prompted...
