Electromagnetic Compatibility Information - Self-Diagnostics SD-T Flex 120 Manual Del Usuario

ELECTROMAGNETIC COMPATIBILITY INFORMATION

The device satisfies the EMC requirements of the international standard IEC 60601-1-2. The require-
ments are satisfied under the conditions described in the table below. The device is an electrical
medical product and is subject to special precautionary measures with regard to EMC which must be
published in the instructions for use.
Portable and mobile HF communications equipment can affect the device. Use of the unit in conjunc-
tion with non-approved accessories can affect the device negatively and alter the electromagnetic
compatibility. The device should not be used directly adjacent to or in conjunction with other elec-
trical equipment.
Table 1
Guidance and declaration of manufacturer-electromagnetic emissions
The device is intended for use in the electromagnetic environment specified below. The customer
or the user of the device should assure that it is used in such an environment.
Emissions test
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Table 2
Guidance and declaration of manufacturer-electromagnetic emissions
The device is intended for use in the electromagnetic environment specified below. The customer
or the user of the device should assure that it is used in such an environment.
IMMUNITY
test
Electrostatic
discharge
(ESD)
IEC 61000-4-2
Electrostatic
transient/
burst
IEC 61000-4-4
Surge ± 1 kV differential mode
IEC 61000-4-5 ± 2 kV common mode
Voltage
<5% UT (>95% dip in UT)
dips, short
interruptions
40% UT (60% dip in UT)
and voltage
variations on
70% UT (30% dip in UT)
power supply
input lines
<5% UT (>95% dip in UT)
IEC 61000-
4-11
Power
frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
Compliance
Group 1
Class B
N/A
N/A
IEC 60601 test level
± 6 kV
contact
± 8 kV air
± 2 kV for
power supply lines
± 1 kV for
input/output lines
for 0.5 cycle
for 5 cycle
for 25 cycle
for 5 sec
3 A/m
Electromagnetic environmentm guidance
The device uses RF energy only for its internal function.
Therefore, its emissions are very low and are not likely to
cause any interference to nearby electronic equipment.
The device 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.
Compliance
level
± 6 kV
contact
± 8 kV air
N/A
N/A
3 A/m
location in a typical commercial or hospi-
Electromagnetic environment guidance
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative humidi-
ty should be at least 30%.
Power frequency magnetic fields should
be at levels characteristic of a typical
tal environment.