Moog CURLIN INFUSION PainSmart - Page 134

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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 specied 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 xed 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 reection from
structures, objects and people.
a
Field strengths from xed 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 xed RF transmitters, an electromagnetic site survey should be considered. If the measured
eld 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, eld 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 Information