Immunity requirements – Activeforever Life Choice Portable Oxygen Concentrator User Manual

Page 20

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18

Medical electrical equipment
needs special precautions
regarding EMC and needs to
be installed and put into
service according to the EMC
information provided in the
accompanying documents.

Immunity Requirements

Guidance and Manufacturer’s Declaration - Electromagnetic Immunity

The Model XYC100 is intended for use in the electromagnetic environment specified below. The customer or the user
of the Model XYC100 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

+/-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

+/-1kV for input/output
lines

+/-2 kV for power
supply lines

Not applicable for
input/output lines

Mains power quality should be that of a
typical commercial or hospital
environment.

Surge
IEC 61000-4-5

+/-1 kV line-to-line

+/-2kV line-to-earth

+/-1 kV line-to-line

+/-2kV 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

< 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 seconds

< 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 seconds

Mains power quality should be that of a
typical commercial or hospital
environment. If the user of the Model
XYC100 requires continued operation

during power mains interruptions, it is
recommended that the Model XYC100
be powered from an uninterruptible
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.

NOTE: U

T

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


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