11.1 EMC REQUIREMENTS FOR THE MODEL 3000
TABLE 3: Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The Model 3000 Phacoemulsification System (Model 3000) is intended for use in the electromagnetic environment specified in this
table. The customer or user of the Model 3000 should ensure that the system is used in such an environment.
IMMUNITY TEST IEC 60601 TEST LEVEL COMPLIANCE LEVEL ELECTROMAGNETIC ENVIRONMENT - GUIDANCE
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80 kHz
3 V(rms) /m
80 MHz to 2.5 GHz
3 Vrms
3 V(rms) /m
Portable and mobile RF Communications
equipment should be used no closer to any
part of the Model 3000, including cables, than
the recommended separation distance
calculated from the equation applicable to the
frequency of the transmitter.
Recommended Separation Distance:
d = 1.2 √ P
d = 1.2 √ P 80 MHz to 800 MHz
d = 1.2 √ 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 the fixed RF transmitters,
as determined by an electromagnetic site
survey,
a
should be less than the compliance
level in each frequency range.
b
Interference may occur in the vicinity of
equipment marked with the following symbol:
NOTE 1: At 80MHz and 800MHz, 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 Model 3000 is used exceeds the applicable RF Compliance level above, the Model 3000
should be o
bserved to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such
as re-orientating or relocating the Model 3000.
b
: Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V(rms) /m.
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