ResMed III IEC60601-1-2, Compliance, Electromagnetic, Immunity test, environment, test level

Models: III

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IEC60601-1-2

Guidance and manufacturer’s declaration – electromagnetic immunity

The VPAP is intended for use in the electromagnetic environment specified below. The customer or the user of the VPAP should assure that it is used in such an environment.

 

IEC60601-1-2

Compliance

 

Electromagnetic

Immunity test

 

environment –

test level

level

 

 

 

guidance

 

 

 

 

 

 

 

 

 

Electrostatic

±6 kV contact

±6 kV contact

 

Floors should be wood,

discharge (ESD)

 

 

 

concrete or ceramic tile. If

IEC 61000-4-2

±8 kV air

±8 kV air

 

floors are covered with

 

 

 

 

synthetic material, the

 

 

 

 

relative humidity should be

 

 

 

 

at least 30%.

 

 

 

 

 

Electrical fast

±2 kV for power

±2 kV

 

Mains power quality should

transient/burst

supply lines

 

 

be that of a typical

IEC 61000-4-4

±1 kV for input/

Not Applicable

 

commercial or hospital

 

 

environment.

 

output lines

 

 

 

 

 

 

 

 

Surge

±1 kV differential

±1 kV differential

 

Mains power quality should

IEC 61000-4-5

mode

mode

 

be that of a typical

 

±2 kV common

±2 kV common

 

commercial or hospital

 

 

environment.

 

mode

mode

 

 

 

 

 

 

 

Voltage dips, short

<5% Ut

< 12V

 

Mains power quality should

interruptions and

(>95% dip in Ut)

(>95% dip in 240V)

 

be that of a typical

voltage variations on

for 0.5 cycle

for 0.5 cycle

 

commercial or hospital

power supply input

 

 

 

environment.

lines.

40% Ut

96V

 

If the user of the VPAP

IEC 61000-4-11

(60% dip in Ut)

(60% dip in 240V)

 

requires continued

 

for 5 cycles

for 5 cycles

 

operation during power

 

70% Ut

168V

 

mains interruptions, it is

 

 

recommended that the

 

(30% dip in Ut)

(30% dip in 240V)

 

VPAP be powered from an

 

for 25 cycles

for 25 cycles

 

uninterruptible power

 

<5% Ut

<12V

 

source

 

 

 

 

(>95% dip in Ut)

(>95% dip in 240V)

 

 

 

for 5 sec

for 5 sec

 

 

 

 

 

 

 

Power frequency

3 A/m

3 A/m

 

Power frequency magnetic

(50/60 Hz)

 

 

 

fields should be at levels

magnetic field

 

 

 

characteristic of a typical

IEC 61000-4-8

 

 

 

location in a typical

 

 

 

 

commercial or hospital

 

 

 

 

environment

 

 

 

 

 

NOTE: Ut is the a.c. mains voltage prior to application of the test level.

 

 

 

 

 

 

(Continued next page)

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ResMed III user manual IEC60601-1-2, Compliance, Electromagnetic, Immunity test, environment, test level, guidance