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9. Specifications and electrical ratings
Guidance and manufacturer’s declaration – electromagnetic immunity
The Jazz Ultra Otoscope / Ophthalmoscope is intended for use in the electromagnetic environment specified below. The customer or the user of
the Jazz Ultra Otoscope / Ophthalmoscope should assure that it is used in such an environment.
Immunity test
IEC 60601 Test level
Compliance level
Electromagnetic environment - guidance
Conducted RF
IEC61000-4-6
Radiated RF
IEC61000-4-3
3 Vrms
150 kHz to 80 MHz
3 V/m
80 MHz to 2.5 GHz
Not Applicable
3 V/m
Portable and mobile RF communications equipment should be used no closer
to any part of the Jazz Ultra Otoscope / Ophthalmoscope, including cables,
than the recommended separation distance calculated from the equation
applicable to the frequency of the transmitter.
Recommended separation distance (d)
d = 1.2
√
P
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).
Fields 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 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 Jazz Ultra Otoscope /
Ophthalmoscope is used exceeds the applicable RF compliance level above, the Jazz Ultra Otoscope / Ophthalmoscope should be observed to verify
normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orientating or relocating the Jazz Ultra
Otoscope / Ophthalmoscope.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.