Users Manual

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Equil
®
Patch Insulin Pump System
IEC 60601-1-2: Table 204
Guidance and manufacturer's declaration – electromagnetic 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.
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 V（ V r m s ）
150kHz~80MHz
10V（Engineering
medical
frequency
band）
150kHz~80MHz
10 V/m
80MHz~2.5GHz
3 V（ V r m s ）
10V
(Engineering
medical
frequency
band）
3 V/m
Portable and mobile RF communications equipment
should be used no closer to any part of the device,
including 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
manufacturer and d is the recommended separation
distance in metres (m).Field strengths from fixed RF
transmitters, as determined by an electromagnetic
site survey,
a
should be less than the compliance level
in each frequency range.
b
Interference may occur in the vicinity of equipment
marked with the following symbol:
Immunity Test IEC 60601 Compliance Electromagnetic environment – guidance
Test Level Level
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones
and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be
predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the measured field strength in
the location in which the device is used exceeds the applicable RF compliance level above, the device
should be observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as reorienting or relocating the device.
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
a
b