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Table 3 Declaration – electromagnetic immunity
The iRenew™ Plus Pain Relief & Recovery System
is intended for use in the electromagnetic environment specifi ed below. The custom-
er or the user should assure that it is used in such an environment.
Immunity test
IEC 60601 test level
Compliance level
Electromagnetic environment guidance
Electrostatic dis-
charge (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 fl oors 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
±1 kV for input/output 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 differential mode
±2 kV common mode
±1 kV differential mode
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 and 70
% U
T
(30 % dip in U
T
) for 25
cycles <5 % U
T
<5 % U
T
(>95 % dip in U
T
) for
0 , 5 cycle 40 % U
T
(60 % dip
in U
T
) for 5 cycles and 70
% U
T
(30 % dip in U
T
) for 25
cycles <5 % U
T
Mains power quality should be that of a typical
commercial or hospital environment. If the user of
the EQUIPMENT or SYSTEM requires continued
operation during power mains interruptions, it is
recommended that the EQUIPMENT or SYSTEM be
powered from an uninterruptible power supply or a
battery.
Summary of Contents for Plus Pain Relief & Recovery ET-8080
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