Stryker SDC Ultra Guia Del Usuario página 71

Guidance and Manufacturer's Declaration--Electromagnetic Immunity
The SDC Ultra™ system is intended for use in the electromagnetic environment specified below. The user of
the SDC Ultra™ system should ensure that it is used in such an environment.
Immunity Test
Conducted RF
IEC 61000-4-6 150 kHz to 80 MHz
Radiated RF
IEC 61000-4-3
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.
(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
SDC Ultra™ system is used exceeds the applicable RF compliance level above, the SDC Ultra™ system should
be observed to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as reorienting or relocating the SDC Ultra™ unit.
(b) Over the frequency range 150 kHz to 80 Mhz, field strengths should be less than 3 V/m.
IEC 60601 Test
Level
3 Vrms
3 V/m
80 MHz to 2.5 GHz
Compliance
Level
Portable and mobile RF communications
equipment should be used no closer to any
part of the SDC Ultra™ system, including its
cables, than the recommended separation
distance calculated from the equation
applicable to the frequency of the transmitter.
Recommended Separation Distance
3 V
3 V/m
d = 1.17√P 80 MHz to 800 MHz
d = 2.33√P 800 MHz to 2.5 GHz
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
(a), should be less that the compliance level in
each frequency range (b).
Interference may occur in the vicinity of
equipment marked with the following
symbol:
Electromagnetic Environment--
Guidance
d = 1.17√P
65