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APPENDIX: ELEC
TROMA
GNETIC COMP
A
TIBILITY
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APPENDIX: ELECTROMAGNETIC COMPATIBILITY
TABLE 1: DIRECTIVES AND MANUFACTURER DECLARATION – ELECTROMAGNETIC EMISSIONS
HUBER 360 MD is intended for use in the electromagnetic environment specified below. The HUBER 360 MD customer or patient should ensure
that it is used in such an environment.
Emissions test
Conformity
Electromagnetic Environment - Directives
RF emissions CISPR 11
Group 1
HUBER 360 MD uses RF energy only for its internal functions.
Therefore, its RF emissions are very low and unlikely to cause
interference in nearby electronic devices.
RF emissions CISPR 11
Class B
HUBER 360 MD may be used in all establishments, including
domestic sites and sites that are directly connected to the low
voltage public power grid, which supplies domestic buildings.
Harmonic emissions IEC 61000-3-2
Class A
Voltage fluctuations and flicker IEC 61000-3-3
Conforms
TABLE 2: DIRECTIVES AND MANUFACTURER DECLARATION – ELECTROMAGNETIC IMMUNITY – EMISSIONS TESTS
HUBER 360 MD is intended for use in the electromagnetic environment specified below. The HUBER 360 MD customer or patient should ensure
that it is used in such an environment.
Emissions test
Conformity
Conformity
Electromagnetic Environment - Directives
Electrostatic
discharge (ESD)
IEC 61000-4-2
± 6 kV on contact
± 8 kV in the air
± 6 kV on contact
± 8 kV in the air
Flooring should be made of wood, concrete, or ceramic tile.
If the floor is covered with synthetic material, relative humidity
should be at least 30%.
Fast transient/burst
IEC 61000-4-4
± 2 kV for electrical
power lines
± 1 kV for input/output
lines
± 2 kV for electrical
power lines
± 1 kV for input/
output lines
The quality of the electrical power network should be equivalent
to that of a typical commercial or hospital environment.
Surge
IEC 61000-4-5
± 1 kV between
phases
± 2 kV between phase
and earth
± 1 kV between
phases
± 2 kV between phase
and earth
The quality of the electrical power network should be equivalent to
that of a typical commercial or hospital environment.
Voltage dips, short
interruptions, and
voltage variations
IEC 61000-4-11
<5% UT
(>95% voltage dip)
during 0.5 cycle
40% UT
(60% UT voltage dip)
during 5 cycles
70% UT
(30 % UT voltage dip)
during 25 cycles
<5% UT
(>95% voltage dip)
during 5s
<5% UT
(>95% voltage dip)
during 0.5 cycle
40 % UT
(60% UT voltage dip)
during 5 cycles
70% UT
(30 % UT voltage dip)
during 25 cycles
<5% UT
(>95% voltage dip)
during 5s
The quality of the electrical power network should be equivalent to
that of a typical commercial or hospital environment. If the HUBER
360 MD patient requires operation to continue during power outages,
the HUBER 360 MD should be powered through an uninterruptible
power supply or a battery.
Power frequency
magnetic field
IEC 61000-4-8
3 A/m
3 A/m
Power frequency magnetic fields should have levels that are
characteristic of a typical hospital or commercial environment.
NOTE: UT is the AC voltage prior to the application of the test level.
