54
Amico Clinical Solutions Corp.
Electromagnetic Compliance Data for iCE Series
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The ME EQUIPMENT or ME SYSTEM is intended for use in the electromagnetic environment specified below. The customer
or the user of the ME EQUIPMENT or ME SYSTEM 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
3 V/m
Portable and mobile RF communications
equipment should be used no closer to any part
of the ME EQUIPMENT or ME SYSTEM, 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
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).
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:
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, land mobile
radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be accurately predicted. To assess the
electromagnetic environment for fixed RF transmitters, an electromagnetic site survey should be considered. If the
measured field strength in the location in which the ME EQUIPMENT or ME SYSTEM is used exceeds the applicable
RF compliance level above, the ME EQUIPMENT or ME SYSTEM should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the
ME EQUIPMENT or ME SYSTEM.
b. Over the frequency range of 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
