Electromagnetic Compatibility Information - SAESHIN Implant XCUBE Instruction Manual

ELECTROMAGNETIC COMPATIBILITY INFORMATION

In IEC/EN 60601-1-2:2007. These limits are designed to provide reasonable protection against
harmful interference in a typical medical installation. This equipment generate, use and can
radiate radio frequency energy and, if not installed and used in accordance with the instructions,
may cause harmful interference to other devices in the vicinity. However, there is no guarantee
that interference will not occur in a particular installation. If this equipment does cause harmful
interference to other devices, which can be determined by turning the equipment off and on,
the user is encouraged to try to correct the interference by one or more of the following
measures:
- Reorient or relocate the receiving device.
- Increase the separation between the equipment.
- Connect the equipment into an outlet on a circuit different from that to which the other
device(s) are connected.
- Consult the manufacturer or filed service technician for help.
(1) Electromagnetic Emissions
Emission test
RF emission – CISPR 11
EN 55011
RF emission – CISPR 11
EN 55011
Harmonic emission –
IEC 61000-3-2
EN 61000-3-2
Voltage fluctuations
Flicker emission –
IEC 61000-3-3
EN 61000-3-3
(2) Electromagnetic Immunity
Immunity test
Electrostatic discharge
(ESD)
IEC 61000-4-2
EN 61000-4-2
Electrical fast transients
IEC 61000-4-4
EN 61000-4-4
Surges
IEC 61000-4-5
EN 61000-4-5
Voltage dips,
short interruptions and
voltage variations
IEC 61000-4-11
EN 61000-4-11
Power frequency (50/60Hz)
magnetic field
IEC 61000-4-8
EN 61000-4-8
39
Compliance
Group 1
Class A
Class A
Compliance
IEC 60601 test level Compliance level
±6kV contact ±6kV contact
±8kV air
±2kV for power ±2kV for power
supply lines ±1kV supply lines ±1kV
for input/output lines for input/output lines
±1kV differential ±1kV differential
mode ±2kV common mode ±2kV common
mode
<5% UT (>95% dip <5% UT (>95% dip
in UT) for 0.5 cycle in UT) for 0.5 cycle
40% UT (60% dip 40% UT (60% dip
in UT) for 6 cycles in UT) for 6 cycles
70% UT (30% dip 70% UT (30% dip
in UT) for 30 cycles in UT) for 30 cycles
<5% UT (>95% dip <5% UT (>95% dip
in UT) for 5s in UT) for 5s
3A/m
Electromagnetic environment - guide
X-CUBE uses RF energy for internal operation.
Therefore, its radiofrequency emissions are very low and are
not likely to cause any interference in nearby equipment.
X-CUBE is suitable to 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.
Electromagnetic environment – guidance
Floors should be wood, concrete or ceramic tile. If
floors are covered with synthetic material, the
±8kV air
relative humidity should be at least 30%.
Mains power quality should be that of a typical
commercial or hospital environment.
Mains power quality should be that of a typical
commercial or hospital environment.
mode
Mains power quality should be that of a typical
commercial or hospital environment. If the user
requires continued operation during power mains
interruptions, it is recommended that the
X-CUBE got power from an uninterruptible
power supply or battery.
Power frequency magnetic fields should be at levels
characteristic of a typical location in a typical
3A/m
commercial or hospital environment.