AMO Catalys OptiMedica, Руководство оператора

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Chapter 5 Maintenance
Page 210 of 314 Part Number: 0160-6411, Rev A, 02/2019
Software Release: cOS 5.00
Table 5.5 Guidance and Manufacturer's Declaration: Electromagnetic Immunity
(This table applies to IEC60601-1-2, 4th Edition compliant CATALYS® manufactured on or after January 1st, 2019)
The CATALYS® System is intended for use in the electromagnetic environment specified below. The customer or the
user of the CATALYS® System should ensure that it 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
MHz (6 Vrms in
ISM radio Bands
within 150kHz -
80MHz)
3 V/m
80 MHz to 2.7
GHz
3 Vrms
3 V/m
Portable and mobile RF communications equipment
should be used no closer to any part of the
CATALYS® Sys-
tem, including its cables, than the recommended separa-
tion 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 = 2.3 √P 800 MHz to 2.7 GHz
Where P is the maximum output power rating of the trans-
mitter in watts (W) according to the transmitter manufac-
turer 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 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 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 sur-
vey should be considered. If the measured field strength in the location in which the
CATALYS® System is used
exceeds the applicable RF compliance level above, the CATALYS® System should be observed to verify normal oper-
ation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocat-
ing the
CATALYS® System.
(b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.