Diagnoptics Age Reader - 14 Electromagnetic Compatibility; Essential Performance; Electromagnetic Emissions; Electromagnetic Immunity

AGE Reader mu Electromagnetic
User Manual compatibility
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14 Electromagnetic compatibility
The AGE Reader mu needs special precautions regarding EMC and needs to be
installed and put into service according to the EMC information provided
in this user manual.
14.1 Essential performance
The use of the medical device does not depend on essential performance.
14.2. Electromagnetic emissions
Guidance and manufacturer’s declaration – electromagnetic emissions
The AGE Reader mu is intended for use in the electromagnetic environment specified below.
The customer or the user of the AGE Reader should assure that it is used in such an environment.
Emissions test Compliance
Electromagnetic environment –
guidance
RF emissions
CISPR 11
Group 1
The AGE Reader mu 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 The AGE Reader mu 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.
Harmonic emissions IEC 61000-3-2 Class A
Voltage fluctuations / flicker emissions
IEC 61000-3-3
Complies
AGE Reader mu Electromagnetic
User Manual compatibility
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14.3. Electromagnetic immunity
Guidance and manufacturer’s declaration – electromagnetic immunity
The AGE Reader mu is intended for use in the electromagnetic environment specified
below. The customer or the user of the AGE Reader mu 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 commercial or hospital
environment.
Surge
IEC 61000-4-5

1 kV
line(s) to line(s)
2 kV
line(s) to earth

1 kV
line(s) to line(s)
2 kV
line(s) 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 % 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 s
UT is the a.c. mains
voltage prior to
application of the
test level.
<5 % U
T
(>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 s
Mains power quality should be that
of a typical commercial or hospital
environment. If the user of the AGE
Reader requires continued
operation during power mains
interruptions, it is recommended
that the AGE Reader be powered
from an uninterruptible power
supply or a 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
commercial or hospital environment.