Boston Scientific LATITUDE Patient Manual page 77

IEC 60601
Immunity test
test level
Radiated 3 V/m 10 V/m
RF (IEC 80 MHz to 80 MHz to
61000-4-3) 2.5 GHz 1000 MHz
3 V/m
1 GHz to
2.7 GHz
8 V/m
5.1 GHz to
5.8 GHz
a. The LATITUDE Communicator is intended for use in the electromagnetic
environment specifi ed above. The customer or the user of the LATITUDE
Communicator should assure that it is used in such an environment.
b. At 80 MHz and 1 GHz, the higher frequency range applies.
c. These guidelines may not apply in all situations. Electromagnetic propagation
is affected by absorption and refl ection from structures, objects, and people.
d. The separation distances are calculated using the following equation
adopted from the 4th edition draft of IEC 60601-1-2: d = (5/E) √P where P is
the maximum output power of the transmitter in watts (W) according to the
transmitter manufacturer, d is the separation distance in meters (m), and E is
the compliance level.
e. The ISM (industrial, scientifi c and medical) bands between 150 kHz and 80
MHz are 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to
27.283 MHz; and 40.66 MHz to 40.70 MHz. The amateur radio bands between
150 kHz and 80 MHz are 1.8 MHz to 2.0 MHz, 3.5 MHz to 4.0 MHz, 5.3 MHz
to 5.4 MHz, 7 MHz to 7.3 MHz, 10.1 MHz to 10.15 MHz, 14 MHz to 14.2 MHz,
LATITUDE
Compliance Electromagnetic environment—
level guidance
d = 0.5 √P (80 MHz to 1000 MHz)
d = 0.29 √P (380 MHz to 390 MHz)
d = 0.36 √P (430 MHz to 470 MHz)
h
d = 0.21 √P (800 MHz to 960 MHz)
d = 1.7 √P (1 GHz to 2.7 GHz)
d = 0.21 √P (1.7 GHz to 1.99 GHz)
i d = 0.21 √P (2.4 GHz to 2.57 GHz)
d = 0.63 √P (5.1 GHz to 5.8 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 fi xed RF
transmitters, as determined
by an electromagnetic site
survey, should be less than
e
the compliance level in each
frequency range.
Interference may occur in the
vicinity of equipment marked
with the following symbol:
Non-iodizing
electromagnetic
radiation
Communicator Patient Manual
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