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FMX Ferromagnetic Surgical System 8
Guidance and manufacturer’s declaration – electromagnetic emissions
The FMX Ferromagnetic Surgical System is intended for use in the electromagnetic environment specified below. The customer or
the user of the FMX Ferromagnetic Surgical System should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment - guidance
RF emissions
CISPR 11 Group 1 The FMX Ferromagnetic Surgical System 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 A The FMX Ferromagnetic Surgical System is suitable for use in all establishments other than domestic, and may be
used in domestic establishments and those directly connected to the public low-voltage power supply network
that supplies buildings used for domestic purposes, provided the following warning is heeded:
WARNING: This equipment/system is intended for use by healthcare professionals only. This equipment/ system may
cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigation
measures, such as reorienting or relocating the FMX Ferromagnetic Surgical System or shielding the location.
Harmonic emissions
IEC 61000-3-2 Class A
Voltage fluctuations/ flicker emissions
IEC 61000-3-3 Complies
Guidance and manufacturer’s declaration
The FMX Ferromagnetic Surgical System is intended for use in the electromagnetic environment specified below. The customer or
the user of the FMX Ferromagnetic Surgical System 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 ±6kV contact
±8kV air ±6kV contact
±8kV 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 ±2kV for power supply lines
±1kV for input/output lines ±2kV for power supply lines
±1kV for input/output lines Mains power quality should be that of a typical
commercial or hospital environment.
Surge
IEC 61000-4-5 ±1kV line to line
±2kV line to earth ±1kV line to line
±2kV line 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
>95% dip in mains voltage value for 0.5 cycle
60% dip in mains voltage value for 5 cycles
30% dip in mains voltage value for 25 cycles
>95% dip in mains voltage value for 5 seconds 100% reduction for 0.5 cycle
60% reduction for 5 cycles
30% reduction for 25 cycles
100% reduction for 250 cycles Mains power quality should be that of a typical commercial or
hospital environment. If the user of the FMX Ferromagnetic
Surgical System required continued operation during power
mains interruptions, it is recommended that the system be
powered from an uninterruptable power supply or 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.
Recommended separation distances between portable and mobile RF communications equipment and the FMX Ferromagnetic Surgical System
The FMX Ferromagnetic Surgical System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer
or the user of the system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications
equipment (transmitters) and the system as recommended below, according to the maximum output power of the communications equipment.
Rated maximum output power of transmitter
W
Separation distance according to frequency of transmitter
m
150 kHz to 80 MHz
d=[1.2] √ P
80 MHz to 800 MHz
d=[1.2] √ P
800 MHz to 2.5 GHz
d=[2.3] √ P
0.01 .12 .12 .23
0.1 .38 .38 .73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable
to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
Note 1: At 80 MHZ and 800 MHZ, the higher frequency range applies
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
Guidance and manufacturer’s declaration – electromagnetic immunity
The FMX Ferromagnetic Surgical System is intended for use in the electromagnetic environment specified below. The
customer or the user of the system should assure that it is used in such an environment.
Immunity Test IEC 60601 test level Compliance level Electromagnetic environment – guidance
Conducted RF
IEC61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80 MHz
3V/m
80 MHz to 2.5 GHz
3Vrms
3V/m
Portable and mobile RF equipment should be used no closer to any part of the FMX Ferromagnetic Surgical System, including
cables, than the recommended separation distance calculated from the equation applicable to the frequency transmitter.
Recommended separation distance: d=[1.2]
√
P
80 MHz to 800 MHz: d=[1.2]
√
P
800 MHz to 2.5 GHz: d=[2.3] √ P
Where P is the maximum output power rating of the transmitter in watts (W) according to the
transmitter manufacturer and d is the recommended separation distance in meters (m).
Field strengths from fixed RF transmitters, as determined by an electromagnetic site
survey, should be less than the compliance level in each frequency range.
Interference may occur in the vicinity of equipment marked with the following symbol:
Note 1: At 80 MHZ and 800 MHZ, the higher frequency range applies
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.