Integra Codman 901001ESUO User Manual

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18
Guidance and Manufacturer’s Declaration-Immunity
The Generator is intended for use in the electromagnetic environment specified below. The customer or the user of the Generator
should ensure that it is used in such an environment.
Immunity Test IEC 60601
test level
Compliance
level
Electromagnetic Environment – Guidance
Conducted RF
(Mains and I/Os)
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
3 Vrms
3 V/m
Portable and mobile RF communications equipment should be used no
closer to any part of the Generator, including cables, than the recommended
separation distance calculated from the equation applicable to the frequency
of the transmier.
Recommended separation distance:
d = 1.2 √ P
d = 1.2 √ P 80 MHz to 800 MHz
d = 2.3 √ P 800 MHz to 2.5 GHz
where P is the maximum output power rating of the transmier in was (W)
according to the transmier manufacturer and d is the recommended
separation distance in meters (m).
Field strengths from fixed RF transmiers
a
, as determined by an
electromagnetic site 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 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 strengths from fixed transmiers, 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 transmiers, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Generator is used
exceeds the applicable RF compliance level above, the Generator should be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as re-orienting or relocating the Generator.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Table 4—Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
Reference Table 204 IEC 60601-1-2 3rd edition
TECHNICAL SPECIFICATIONS AND ENVIRONMENTAL REQUIREMENTS

Integra Codman 901001ESUO Specifications

General

Brand	Integra
Model	Codman 901001ESUO
Category	Medical Equipment
Language	English