ITC Avoximeter 1000E Whole Blood Oximeter User Manual

Page 78

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ITC AVOXimeter 1000E Operator’s Manual

72

Guidance and Manufacturer’s Declaration – Electromagnetic
Immunity

The ITC AVOXimeter 1000E is intended for use in the electromagnetic environment specified
below. The customer or the user of the ITC AVOXimeter 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

+ 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 for

power supply

lines

+1 kV for

input/output

lines

Mains power quality should be that of a

typical domestic, 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 domestic, 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

<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

Mains power quality should be that of a

typical domestic, commercial or

hospital environment.

If the user of the ITC AVOXimeter

1000E requires continued operations

during power mains interruptions, it is

recommended that the ITC

AVOXimeter 1000E be powered from

an uninterruptible power supply or

battery.

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 domestic,

commercial or hospital environment.

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