22 en – Compex SP4.0 User Manual

Page 24

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22

EN

GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY

The Compex stimulator is intended for use in the electromagnetic environment specified below. The customer or the user of

the Compex stimulator 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

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

±2kV for power supply

lines

±1kV for input/output

lines

±2kV (power lines)

Not Applicable

(I/O lines)

Mains power quality should be that of a

typical commercial or hospital environment.

Surge

IEC 61000-4-5

±1kV Line to Line (or

Neutral)

±2kV line(s) to earth

±1kV Line to Line

Not Applicable

(Line to Earth)

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 a

<5% UT

(>95% dip in UT) for

0,5 cycle

40% UT

(60% dip in UT) for 5

cycles

70% UT

(30% dip in UT) for 25

cycles

<5% UT

(>95% dip in UT) for

5 sec

<5% UT

(>95% dip in UT) for

0,5 cycle

40% UT

(60% dip in UT) for 5

cycles

70% UT

(30% dip in UT) for 25

cycles

<5% UT

(>95% dip in UT)

for 5 sec

Mains power quality should be that of a

typical commercial or hospital environment.

If the user of the Compex stimulator requires

continued operation during power mains

interruptions, it is recommended that the

Compex stimulator be powered from an

uninterrupted power supply or a battery.

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.

a UT is the a.c mains voltage prior to application of the test level.

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