XVIVO 11.01.201, Инструкция по эксплуатации

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11.01.601.7c EN Page 34 of 40
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Declaration on electromagnetic emissions (Table 1),
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Declaration on electromagnetic immunity (Table 2),
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Declaration on RF wireless communication equipment Immunity (Table 3).
Ta
ble 1. Guidance and manufacturer’s declaration – electromagnetic emissions
The Liver Assist is intended for use in the electromagnetic environment specified below. The customer or the user
of this device should assure that it is used in such an environment.
Emissions test
–guidance
Compliance Electromagnetic environment
RF emissions
CISPR11 (EN 55011) Group 1 The Liver Assist uses RF energy only for its internal
function. Therefore, its RF emissions are very low and are
not likely to cause any interference in nearby electronic
equipment.
RF emissions
CISPR11 (EN 55011) Class A The emissions characteristics of the Liver Assist make it
suitable for use in industrial areas and hospitals
(CISPR 11 class A). If it is used in a residential
environment (for which CISPR 11 class B is normally
required) this equipment might not offer adequate
protection to radio-frequency communication services. The
user might need to take mitigation measures, such as
relocating or re-orienting the equipment.
Harmonic emissions
IEC 61000-3-2 Class A
Voltage fluctuations/
flicker emissions
IEC 61000-3-3 Complies
Table 2. Guidance and
manufacturer’s declaration – electromagnetic immunity
The Liver Assist is intended for use in the electromagnetic environment specified below. The customer or the user of this
device should assure that it is used in such an environment.
IMMUNITY test
IEC 60601
test level
Compliance level
Electromagnetic environment
–
guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2 ±8 kV contact
±15 kV air ±8 kV contact
±15 kV air Floors should be wood, concrete or ceramic tile.
If floors are covered with synthetic material, the
relative humidity should be at least 30 %.
Electrical fast
transient/burst
IEC 61000-4-4 ±2 kV 100KHz for
power supply lines
±1 kV for input/ output
lines ±2 kV 100KHz for
power supply lines
±1 kV for input/ output
lines Mains power quality should be that of a typical
commercial or hospital environment.
Surge
IEC 61000-4-5 ± 0,5 & ±1 kV
line(s) to line(s)
±0,5, ±1 & ±2 kV
line(s) to earth ± 0,5 & ±1 kV
line(s) to line(s)
±0,5, ±1 & ±2 kV
line(s) to earth Mains power quality should be that of a typical
commercial or hospital environment.