COOK Medical Rhapsody H-30 User Manual page 30

Guidance and Manufacturer's Declaration - Electromagnetic Immunity
The Rhapsody H-30 Holmium Laser System is intended for use in the electromagnetic environment specified
below. The customer or the end user of the laser system should ensure that it is used in such an environment.
Immunity IEC 60601 Test
Test Level
Conducted RF 3 Vrms
IEC 61000-4-6 150 KHz to 80 MHz
Radiated RF 3 V/m
IEC 61000-4-3 80 MHz to 2.5 GHz
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 strength from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radios, AM and
FM radio broadcasts, and TV broadcasts cannot be predicted with accuracy. To assess the electromagnetic environment in the presence of fixed RF
transmitters, consider an electromagnetic site survey. If the measured field strength in the location in which the laser system is used exceeds the
applicable RF compliance level above, verify that the laser system is operating normally. If abnormal performance is observed, additional measures
may be necessary, such as re-orienting or relocating the laser system.
Over the 150 KHz-80 MHz frequency range, field strength should be less than 3 V/m.
b
Cook Medical © 2019
IEC 60601-1-2 Table 3
Compliance Electromagnetic Environment Guide
Level
3 Vrms Portable and mobile RF communication
equipment should be no closer to any part of the
3 V/m
Rhapsody H-30 Holmium Laser System, including
cables, than the recommended separation
distance calculated from the equation applicable
to the frequency of the transmitter.
Recommended separation distance:
d=1.167*sqrt(P)
d=1.167*sqrt(P) from 80 MHz to 800 MHz
d=2.333*sqrt(P) from 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
should be less than the compliance level in each
frequency range
vicinity of equipment marked with the following
symbol:
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b . Interference may occur in the
Chapter 4
Installation
a
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