Copyright © 2013, Condor Instruments Ltda.
82
Av. Brigadeiro Luis Antonio, 551, cj 124 - Cep:01318-000
Manufacturer’s declaration - Electromagnetic
Immunity and Emission
The medical electrical equipment needs special precautions regarding electromagnetic compatibility (EMC) and needs to be
installed and put into service according to EMC information contained herein.
Manufacturer’s declaration – Electromagnetic Emission
The product is suitable for use in a specific electromagnetic environment. The customer and/or the user of the product should assure that it is used in an
electromagnetic environment as described below.
Emission Test
Compliance
Electromagnetic Environment Guidance
RF-Emission
(Radio frequency) CISPR11
Group 1
The product use RF energy only for its internal function. Therefore, its RF emissions are very
low and not likely to cause any interference in nearby electronic equipment.
RF-Emission
(Radio frequency) CISPR11
Class B
The product 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 purpose.
Harmonic emissions
IEC 61000-3-2
Do not Apply
Voltage fluctuations / flicker
emissions
IEC 61000-3-3
Complies
Manufacturer’s declaration – Electromagnetic Immunity I
The product is suitable for use in a specific electromagnetic environment. The customer and/or the user of the product should assure that it is used in an
electromagnetic environment as described below.
Immunity Test
IEC 60601-1-2 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
Floor 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/bursts
IEC 61000-4-4
± 2 kV for power
supply lines
± 1 kV for
input/output lines
Do not Apply
The device is recharged via computer, is not subject directly to the
power source
Surge
IEC61000-4-5
± 1 kV differential
mode
± 2 kV common mode
Do not Apply
The device is recharged via computer, is not subject directly to the
power source
Voltage dips, short interruptions
and voltage variations on power
supply input lines
IEC61000-4-11
<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
Do not Apply
The device is recharged via computer, is not subject directly to the
power source
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.
NOTE 1:
U
T
is the mains (AC) voltage before apply test levels