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ITC Avoximeter 4000 Whole Blood CO-Oximeter User Manual

Page 75

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ITC AVOXimeter 4000 Operator’s Manual

Guidance and Manufacturer’s Declaration – Electromagnetic
Immunity

The ITC AVOXimeter 4000 is intended for use in the electromagnetic environment specified
below. The customer or the user of the ITC AVOXimeter 4000 should assure that it is used in
such an environment.

IEC 60601

Compliance

Electromagnetic Environment -

Immunity Test

Test Level

Level

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

4000 System requires continued

operations during power mains

interruptions, it is recommended that

the ITC AVOXimeter 4000 System 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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