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E E l l e e c c t t r r o o m m a a g g n n e e t t i i c c C C o o m m p p a a t t i i b b i i l l i i t t y y
Like other electrical medical equipment, SDC3 requires special precautions to ensure
electromagnetic compatibility with other electrical medical devices. To ensure electromagnetic
compatibility (EMC), SDC3 must be installed and operated according to the EMC information
provided in this manual.
The SDC3 has been designed and tested to comply with IEC 60601-1-2 requirements for EMC
with other devices.
N N o o t t e e - - This equipment is for use in a professional healthcare environment. It is not for use in the
radio frequency (RF) shielded room of a medical electrical system for magnetic resonance
imaging, where the intensity of electromagnetic disturbances is high.
N N o o t t e e - - This equipment is not likely susceptible to interference from high frequency (HF) surgical
instruments in the Special Environment of being in close proximity to an active HF surgical
instrument. In the case that HF surgical interference is observed, adjust the separation distance of
the equipment.
W W A A R R N N I I N N G G - -
•
Portable and mobile RF communications equipment may affect the normal function of the
SDC3.
•
Do not use cables or accessories other than those provided with the SDC3, as this may result
in increased electromagnetic emissions or decreased immunity to such emissions.
•
If the SDC3 is used adjacent to or stacked with other equipment, observe and verify normal
operation of the SDC3 in the configuration in which it will be used prior to using it in a surgical
procedure. Consult the tables below for guidance in placing the SDC3.
Guidance and Manufacturer's Declaration: Electromagnetic Immunity
SDC3 is intended for use in the electromagnetic environment specified below. The customer or the user of SDC3 should ensure
that it is used in such an environment.
(a) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios,
amateur radio, AM and FM radio broadcast, and TV broadcast, cannot be predicted theoretically with accuracy. To assess the
electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured
field strength in the location in which the SDC3 system is used exceeds the applicable RF compliance level above, the SDC3
system should be observed to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as reorienting or relocating the SDC3 unit.
(b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Guidance and Manufacturer's Declaration: Electromagnetic Emissions
SDC3 is intended for use in the electromagnetic environment specified below. The customer or the user of SDC3 should ensure
that it is used in such an environment.
Emissions test
RF emissions CISPR 11
EN
86
Compliance
Group 1
Electromagnetic Environment - guidance
SDC3 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.
P23566L
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