cefar Direct TENS - Page 28

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Direct TENS
™
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity
The Direct TENS™ Electrotherapy System is intended for use in the electromagnetic environment specified below. The
customer or the user of the Direct TENS™ Electrotherapy System 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
±6kV contact
±8kV air
±6kV contact
±8kV air
Risk assessment on the Direct TENS™
Electrotherapy System indicates the
compliance levels claimed are accept-
able when ESD-precautionary mea-
sures are taken.
Electrical fast
transient/burst IEC
61000-4-4
±2kV for power supply lines
±1kV for input/output lines
Not Applicable - Battery
powered
Not Applicable - signal
lines less then 3 meters
Mains power quality should be that
of a typical commercial or hospital
environment.
Surge
IEC 61000-4-5
+ 1kV dierential mode (line
to line)
+ 2kV common mode (line
to ground)
Not Applicable - Battery
powered
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 5 sec
Not Applicable - Battery
powered
Mains power quality should be that
of a typical commercial or hospital
environment. If the user of the Direct
TENS™ Electrotherapy System requires
continued operation during power
mains interruptions, it is recommended
that the Direct TENS™ Electrotherapy
System be powered from an uninter-
rupted power supply.
Power frequency
(50/60Hz)
magnetic field
IEC 61000-4-8
3 A/m 3 A/m
Power frequency magnetic fields
should be at levels characteristic of a
typical location in a typical commercial
or hospital environment.
NOTE: U
T
is the AC mains voltage prior to application of the test level.