ITC IRMA TruPoint Blood Analysis System User Manual

Page 136

B.4

Guidance and Manufacturer’s Declaration – Electromagnetic Emissions

The IRMA TruPoint Blood Analysis System AC adapter is intended for use in the electromagnetic
environment specified below. The customer or the user of the IRMA TruPoint Blood Analysis System AC
adapter should assure that it is used in such an environment.

Emissions Test

Compliance

Electromagnetic Environment - Guidance

RF Emissions
CISPR 11

Group 1

The IRMA TruPoint Blood Analysis System AC
adapter uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not
likely to cause any interference in nearby electronic
equipment.

RF Emissions
CISPR 11

Class B

Harmonic Emissions
IEC 61000-3-2

Class A

Voltage Fluctuations/
Flicker Emissions
IEC 61000-3-3

Complies

The IRMA TruPoint Blood Analysis System AC
adapter is suitable for use in all establishments,
including domestic establishments and those directly
connected to the public low-voltage power supply
network that supplies buildings used for domestic
purposes.

Guidance and Manufacturer’s Declaration – Electromagnetic Immunity

Immunity Test

IEC 60601 Test

Level

Compliance Level

Electromagnetic

Environment - Guidance

Electrostatic
Discharge (ESD)
IEC 61000-4-2

+ 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

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 % 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

<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

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

If the user of the IRMA TruPoint
Blood Analysis System AC adapter
requires continued operations during
power mains interruptions, it is reco-
mmended that the IRMA TruPoint
Blood Analysis System AC adapter
be powered from an uninterruptible
power supply or battery.

Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8

3 A/m

Power frequency magnetic fields
should be at levels characteristic of a
typical location in a typical domestic,
commercial or hospital environment.

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