Stryker PneumoSure, Инструкция по эксплуатации

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Electromagnetic compatibility
83
EN
14.4 Guidelines and Manufacturer's Statement - Electromagnetic In-
terference Immunity
The device PNEUMO SURE High Flow Insufflator is intended for use in the electro-
magnetic environment specified below. The customer or operator of the device
should make sure the device is operated within such an environment.
*Note: UT is the mains alternating voltage before applying the test levels.
Electromagnetic
interference
immunity tests
Test level Compliance Electromagnetic envi-
ronment guidelines
Discharge of static
electricity (ESD)
according to
IEC 61000-4-2
± 6 kV contact
discharge, ± 8 kV
air discharge
In compli-
ance
Floors should be made
from wood or concrete
or covered with ceramic
tiles. If the floor cover-
ing consists of synthetic
material, the relative
humidity should be at
least 30%.
Electrical fast
transients / bursts
according to
IEC 61000-4-4
± 2 kV for power
lines, ± 1 kV for
input and out-
put lines.
In compli-
ance
The quality of the sup-
ply voltage should be
the same as the voltage
of a typical business or
hospital environment.
Surges according
to IEC 61000-4-5
± 1 kV normal
mode voltage,
± 2 kV common
mode voltage
In compli-
ance
The quality of the sup-
ply voltage should be
the same as the voltage
of a typical business or
hospital environment.
Blackouts, brown-
outs, and fluctua-
tions of the power
supply according
to IEC 61000-4-11
< 5% UT* (> 95%
crash of the UT)
for ½ period
In compli-
ance
The quality of the sup-
ply voltage should be
the same as the voltage
of a typical business or
hospital environment.
If the user/operator of
device requires the con-
tinuation of functional-
ity after power
interruptions/disrup-
tions, it is recom-
mended to supply the
device with power from
an uninterruptable
power supply.
40% UT (60%
crash of the UT)
for 5 periods
70% UT (30%
crash of the UT)
for 25 periods
< 5% UT (> 95%
crash of the UT)
for 5 s
Supply frequency
magnetic field
(50/60 Hz) accord-
ing to IEC 61000-
4-8
3 A/m In compli-
ance
Magnetic fields of the
mains power fre-
quency should comply
with the typical values
of business and hospi-
tal environments.