Labomed PRIMA ENT User Manual page 35

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Equipment and Systems that are NOT Life-supporting
Guidance and manufacturer's Declaration - Electromagnetic Immunity
The Prima ENT/DNT is intended for use in the Electromagnetic environment specified below. The customer or
user of the Prima ENT/DNT should ensure that it is used in such an environment.
Immunity Test IEC 60601 Test Level Compliance
Conducted RF IEC 3 vrms 150 kHz to 80
61000-4-6 MHz
Radiated RF IEC 80MHz to 2.5 GHz @
61000-4-3 3V/m
Note 1: At 80 MHz to 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.
* 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. The measured field strength in the
location in which 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.
* Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1] V/m.
Guidance and manufacturer's Declaration
Electromagnetic Immunity
Level
(v1) = 3 vrms
(E1) = 3 vrms
Electromagnetic environment Guidance
Portable and mobile RF Communications equipment
should be used no closer to any part of the Prima
ENT/DNT, including cables, than the recommended
separation distance calculated from the equation
applicable to the frequency of the transmitter.
Recommended Separation Distance:
d=(3.5/v1)(Sqrt P)
d=(3.5/E1)(Sqrt P)
80 to 800 MHz
d=(7/E1)(Sqrt P)
800 MHz to 2.5 GHz
Where P is the max output power rating of
the transmitter in watts (W) according to
the transmitter manufacturer and d is the
recommended separation distance in meters (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey,
should be less than the compliance levels in each
frequency range.
Interference may occur in the vicinity of equipment
marked with the following symbol
Prima ENT/DNT
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