Table 12. Guidance And Manufacturer's Declaration - Electromagnetic Immunity - For All Medical Electrical Equipment And Medical Electrical Systems That Are Not Life-Supporting - Adaptec Sensica UO Instructions For Use Manual

Sensica™ UO System for ICU Instructions for Use, Model No. SCCS-1001, ver. 1001
Table 12. Guidance and Manufacturer's Declaration – Electromagnetic Immunity – for
all Medical Electrical Equipment and Medical Electrical Systems that are not Life-
Supporting
The Sensica™ UO System for ICU is intended for use in the electromagnetic environment specified below.
The customer or the user of the Sensica™ UO System for ICU should assure that it is used in such an
environment.
Immunity Test IEC 60601 Test
Level
Conducted RF 3 Vrms
IEC 61000-4-6 150 kHz to 80 MHz
Radiated RF 3 V/m
IEC 61000-4-3 180 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 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 Sensica™ UO
System for ICU is used exceeds the applicable RF compliance level above, the Sensica UO System for ICU
should be observed to verify normal operation. If abnormal performance is observed, additional measures may
be necessary, such as re-orienting or relocating the Sensica UO System for ICU.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
P/N 005-0175 Rev A
Compliance Electromagnetic Environment - Guidance
Level
Portable and mobile RF communications
equipment should be used no closer to any part
of the Sensica™ UO System for ICU, including
cables, than the recommended separation
distance calculated from the equation applicable
to the frequency of the transmitter.
Recommended separation distance
3 V
d = 1.2 √P
d = 1.2 √P 80 MHz to 800MHz
3 V/m
d = 2.3 √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,
should be less than the compliance level in each
frequency range.
Interference may occur in the vicinity of
equipment marked with the following symbol:
Adaptec Medical Devices
b
a
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