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ResMed C16389 User Manual

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Guidance and manufacturer’s declaration – electromagnetic immunity

The VPAP Malibu is intended for use in the electromagnetic environment specified below. The

customer or the user of the VPAP Malibu should assure that it is used in such an environment.

Immunity test

IEC60601-1-2
test level

Compliance
level

Electromagnetic
environment –
guidance

Electrostatic

discharge (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

floors 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

Not Applicable

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

±2 kV common

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% 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

< 12V

(>95% dip in 240V)

for 0.5 cycle

96V

(60% dip in 240V)

for 5 cycles

168V

(30% dip in 240V)

for 25 cycles

<12V

(>95%dip in 240V)

for 5 sec

Mains power quality should

be that of a typical

commercial or hospital

environment.

If the user of the

VPAP Malibu requires

continued operation during

power mains interruptions,

it is recommended that the

VPAP Malibu be powered

from an uninterruptible

power source

Power frequency

(50/60 Hz)

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: Ut is the AC. mains voltage prior to application of the test level.

268106r1.book Page 38 Thursday, November 30, 2006 2:35 PM