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Guidance and manufacture’s declaration – electromagnetic immunity –
for ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING
Guidance and manufacture’s declaration – electromagnetic immunity
The Pro7 is intended for use in the electromagnetic environment specied below. The customer or the user of
Pro7 should assure that it is used in such an environment.
Immunity test IEC 60601 test Compliance Electromagnetic environment
level level - guidance
Portable and mobile RF communications
equipment should be used no closer to
any part of the Pro7, including cables, than
the recommended separation distance
calculated from the equation applicable to the
frequency of the transmitter.
Recommended separation distance
Conducted RF 3 Vrms 3 Vrms
IEC 61000-4-6 150 kHz to 80 MHz
Radiated RF 3 V/m 3 Vrms 80 MHz to 800 MHz
IEC 61000-4-3 80 MHz to 2.5 GHz 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 xed 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 reection from structures, objects and people.
a
Field strengths from xed 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 xed RF transmitters, an electromagnetic site
survey should be considered. If the measured eld strength in the location in which the Pro7 is used exceeds
the applicable RF compliance level above, the Pro7 should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as reorienting or relocating the Pro7.
b
Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than 3 V/m.
The following symbols may appear in this manual or on the machine. Some of
the symbols represent standards and compliances associated with the machine
and its use.
Caution: Consult accompanying documents
CE Mark: conforms to essential requirements of the Medical Device Directive
93/42/EEC.
CE Mark: conforms to essential requirements of the R&TTE Directive 1999/5/EC
Class II equipment
Date of manufacture.
Manufacturer
Type B applied part
DISPOSAL: Do not dispose this product as unsorted municipal waste. Collection
of such waste separately for special treatment is necessary.
CB Certication Scheme
C-TICK Certication from the Australian Communications Authority
GOST - Standard of Russia
Compliant with RoHS Directive 2002/95/EC
CQC Safety and EMC Product Certication Mark
Compliance with DENAN law Japan
Symbol Descriptions
Pd 167.1=
Pd 167.1=
Pd 167.1=
16
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