Medisafe SI PCF, User Manual

Page: 75 / 81

Appendices SI PCF User Manual
Ref: DOC03148 Issue 1 Friday, 06 January 2017
Page 75 of 81
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The SI PCF is intended for use in the electromagnetic environment specified below. The customer or the
user of the SI PCF should assure that it is used in such an environment.
Immunity test
IEC 60601 test
level
Compliance
level
Electromagnetic environment -
guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80 MHz
3 V/m
80 MHz to 2.5 GHz
3 Vrms
150 kHz to 80
MHz
3 V/m
80 MHz to 2.5
GHz
Portable and mobile RF communications
equipment should be used no closer to any
part of the SI PCF, including cables, than
the recommended separation distance
calculated from the equation applicable to the
frequency of the transmitter.
Recommended separation distance (d)
d = 1.2√P
d = 1.2√P 80 MHz to 800 MHz
d = 2.3√P 800 MHz to 2.5 GHz
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).
Fields strengths from fixed RF transmitters, as
determined by an electromagnetic site survey
(
see Note a ) should be less than the
compliance level in each frequency range (see
Note b )
Interference may occur in the vicinity of
equipment marked with the following symbol:
Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
a. 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 SI PCF is used exceeds the
applicable RF compliance level above, the SI PCF should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as re-orienting or relocating the SI PCF.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.