BIOMET innerVue II, Руководство по эксплуатации и уходу

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5
Operation and Care Manual
Guidance and Manufacturer’s Declaration—Electromagnetic Immunity
The InnerVue
™
II Diagnostic Scope System is intended for use in the electromagnetic environment speci-
fied below. The customer or the user of the InnerVue
™
II Diagnostic Scope System should assure that it is
used in such an environment.
Immunity
Test
IEC 60601 Test
Level
Compliance
Level
Electromagnetic Environment—Guidance
Conducted
RF IEC
61000-4-6
Radiated RF
IEC 61000-
4-3
3 V rms
150 kHz to 80
MHz outside of
ISM bands
10Vrms
150 kHz to 80
MHz in ISM bands
10 V/m
80 MHZ to 2.5
GHz
10 Vrms
10 V/m
Portable and mobile FR communications equip-
ment should be used no closer to any part of the
InnerVue
™
II Diagnostic Scope System including
cables, than the recommended separation distance
calculated from the equation applicable to the
frequency of the transmitter.
Recommended separaton distance
d = (3.5/3)P
d = (3.5/3)P 80 MHz to 800 MHz
d = (7/3)P 800 MHz to 2.5 GHz
Where P is the maximum output power rating of
the transmitter in watts (W) according to the trans-
mitter manufacturer and d is the recommended
separation distance in meters (m). Field strengths
from fixed RF transmitters, as determined by and
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 80MHz and 800MHz, 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, amatuer radios, AM and FM radio broadcast and TV broadcast cannot be
predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed FR
transmitters, an electromagnetic site survey should be considered. IF the measured field strength in the
location in which the Xe3000 is used exceeds the applicable FR compliance level above, the InnerVue ™II
Diagnostic Scope System should be observed to verify normal operation. If abnormal performance
is observed, additional measures may be necessary, such as reorienting or relocating the InnerVue
™
II
Diagnostic Scope System.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Introduction