Gendex AcuCam Concept IV FWT User Manual page 57

Guidance and Manufacturer's Declaration - electromagnetic immunity -for all equipment and
systems that are not life-supporting (see 6.8.3.201 b).
The AcuCam® Concept® IV FWT intraoral camera system is intended for use in the
electromagnetic environment specified below. The customer or user of the Concept IV FWT
camera system must ensure that it is used in such an environment.
Guidance and Manufacturer's Declaration –Electromagnetic Immunity
Immunity Test
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
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 Concept IV FWT camera system is used exceeds the
applicable RF compliance level above, the Concept IV FWT camera 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 Concept IV FWT camera system.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m
032-0161-EN Rev 5
IEC 60601 Compliance
Test Level Level
3 Vrms 3V
150 kHz to
80 MHz
3 V/m 3 V/m
80 MHz to
2,5 GHz
Compliance with Applicable Standards
Electromagnetic Environment – Guidance
Portable and mobile RF communications equipment
should be used no closer to any part of the Concept IV
FWT camera system, including cables, than the
recommended separation distance calculated from the
equation applicable to the frequency of the transmitter.
Recommended separation distance
80 MHz to 800 MHz
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 meters (m).
Field strengths from fixed RF transmitters, as deter-
mined by an electromagnetic site survey,
less than the compliance level in each frequency
b
range.
Interference may occur in the vicinity of equipment
marked with the following symbol:
a
should be
7-3