Moog CURLIN INFUSION PainSmart, User Manual

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Guidance and Manufacturer’s Declaration - Electromagnetic Immunity
The PainSmart™ IOD , 6000 CMS™ and 6000 CMS™ IOD™ is intended for use in electromagnetic environment specified below. The
customer or the user of the PainSmart™ IOD, 6000 CMS™ and 6000 CMS™ IOD™should assure that it is used in such an environment.
Immunity Test
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80 MHz
3 V/m
80 MHz to 2,5 GHz
[ v
1
]v
3V/m
[ E
1
] V/m
3V/m
Portable and mobile RF communications
equipment should be used no closer to any part
of the Painsmart™ IOD, 6000 CMS™ and 6000
CMS™ IOD™ including cables, than the
recommended separation distance calculated
from the equation applicable to the frequency of
the transmitter.
Recommended Separation Distance
d = [ ] √P d = 1.17 √P 80 MHz to 800 MHz
d
= [ ] √P 80 MHz to 800 MHz
d = [ ] √P 800 MHz to 2.5 GHz
d = 2.33 √P 800 MHz to 2.56 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 metres [m].
Field strengths from fixed RF transmitters, as
determined by an electromagnetic sites 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, the higher the frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorbtion 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 [ME EQUIPMENT or ME SYSTEM] is used exceeds the applicable RF compliance
level above, the [ME EQUIPMENT or ME SYSTEM] should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as re-orienting or relocating the [ME EQUIPMENT or ME SYSTEM].
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [ V
1
] V /m.
IEC 60601
Test Level
Compliance Level Electromagnetic Environment-
Guidance
3,5
V
1
3,5
7
E
1
E
1
Clinician Inf
or
ma
tion