Carestream DENTAL RVG 142, Руководство пользователя

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14 RVG 142, RVG 5200 and RVG 6200 Safety, Regulatory User Guide (SM847)
Ed06
Guidance and Manufacturer’s Declaration - Electromagnetic
Immunity
(IEC 60601-1-2)
RVG 142, RVG 5200 and RVG 6200 are intended for use in the electromagnetic environment
specified below. The customer or the user of RVG 142, RVG 5200 and RVG 6200 should assure
that it is used in such an environment.
Immunity Test
IEC 60601 Test Level
Electromagnetic Environment - Guidance
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to 80 MHz and
6V at ISM Frequencies
and
amateur radio
frequencies
Environment of a care facility
professional health.
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to 2.7 GHz
Test levels and
frequencies according to
table 9 from IEC
60601-1-2: 2014
WARNI NG: Portable RF communications
equipment (including peripherals such as
antenna cables and external antennas)
should be used no closer than 30 cm (12
inches) to any part of the RVG including
cables specified by the manufacturer.
Otherwise, degradation of the
performance of this equipment could
result
NOTE: 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 RVG systems are used exceeds the
applicable RF compliance level above, the RVG systems should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such as
re-orienting or relocating the RVG.
Note: Uninterrupted communication is essential for electromagnetic
compatibility.
Compliance With International Regulations
Medical Device directives 93/42/European Economic Community (EEC), Class IIa following the
rule 16 as amended by 2007/47/EEC. RVG 142, RVG 5200 and RVG 6200 are active devices
specifically intended for the recording of X-ray diagnostic images.
Medical Device directives 93/42/European Economic Community (EEC), Class I following the rule
12 as amended by 2007/47/EEC. The RVG Connect unit is an active device.
FDA Center for Devices & Radiological Health (CDRH-CFR title 21 chapter 1) (USA)
Medical Devices Regulations (Canada).
Federal Communications Commission (FCC Part 15) for the RVG Connect (USA)
Directive 2011/65/EU on the Restriction of the use of certain Hazardous Substances in electrical
and electronic equipment (RoHS)