NDS ExpandOR, Руководство по установке

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39
Electromagnetic Compatibility Tables
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The product is intended for use in the electromagnetic environment specified below. The customer or the user of the product
should assure that it is used in such an environment.
Emissions Compliance Electromagnetic Environment Guidance
RF emissions
CISPR 11
Group 1
The product 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
CISPR 11 Class B
The product is suitable for use in all establishments, including domestic
establishments and those directly connected to the public low-voltage
power supply network that supplies buildings used for domestic purposes.
Harmonic emissions
IEC 61000-3-2 Not Applicable
Voltage fluctuations/
flicker emissions
IEC 61000 -3-3
Not Applicable
Guidance and Manufacturer’s Declaration 211; Electromagnetic Immunity
The product is intended for use in the electromagnetic environment specified below. The customer or the user of the product
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 ±6 kV contact
±8 kV air ±6 kV contact
±8 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 for power
supply lines ±2 kV for power
supply lines Mains power quality should be that of a
typical commercial or hospital environment.
Surge
IEC 61000-4-5 ±1 kV line(s) and neutral ±1 kV line(s) and neutral Mains power quality should be that of a
typical commercial or hospital environment.
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11 <5 % U
T
(>95 % dip in U
T
)
for 0,5 cycle
40 % U
T
(60 % dip in U
T
)
for 5 cycles
70 % U
T
(30 % dip in U
T
)
for 25 cycles
<5 % U
T
(>95 % dip in U
T
)
for 5s
<5 % U
T
(>95 % dip in U
T
)
for 0,5 cycle
40 % U
T
(60 % dip in U
T
)
for 5 cycles
70 % U
T
(30 % dip in U
T
)
for 25 cycles)
<5 % U
T
(>95 % dip in U
T
) for 5s
Mains power quality should be that of a
typical commercial or hospital environment.
If a dips or an interruption of mains power
occurs, the current of the product may be
dropped off from normal level, it may be
necessary to use uninterruptible power
supply or a battery.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8 3 A/m Not applicable Not applicable
NOTE: U
T
is the AC mains voltage prior to application of the test level.
All medical electronic devices must conform to the requirements of IEC 60601-1-2. Precautions, adherences to
the Electromagnetic Compatibility (EMC) tables guideline information provided in this manual and
verification of all medical devices in simultaneous operation are required to ensure the electromagnetic
compatibility and co-existence of all other medical devices prior to a surgical procedure. The EMC tables below, and
on pages 43 and 44, are provided for your reference.