Ethicon Endo-Surgery ECHELON FLEX 45 Mode D'emploi page 9

The ECHELON FLEX Powered Articulating Endoscopic Linear Cutter is intended for use in the electromagnetic environment specifi ed
below. The customer or the user of the ECHELON FLEX Powered Articulating Endoscopic Linear Cutter should assure that it is used in such
an environment.
Power frequency
(50/60 Hz) 3 A/m 3 A/m
magnetic fi eld
IEC 61000-4-8
NOTE UT is the a.c. mains voltage prior to application of the test level.
The ECHELON FLEX Powered Articulating Endoscopic Linear Cutter is intended for use in the electromagnetic environment specifi ed
below. The customer or the user of the ECHELON FLEX Powered Articulating Endoscopic Linear Cutter should assure that it is used in such
an environment.
Immunity test IEC 60601Test
Level
Conducted RF 3 Vrms
IEC 61000-4-6 150 kHz to 80 MHz
Radiated RF 3 V/m
IEC 61000-4-3 80 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 refl ection from
structures, objects and people.
Field strengths from fi xed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio,
a
AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment
due to fi xed RF transmitters, an electromagnetic site survey should be considered. If the measured fi eld strength in the location in which the
ECHELON FLEX Powered Articulating Endoscopic Linear Cutter is used exceeds the applicable RF compliance level above, the ECHELON
FLEX Powered Articulating Endoscopic Linear Cutter should be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as re-orienting or relocating the ECHELON FLEX Powered Articulating Endoscopic Linear Cutter.
Over the frequency range 150 kHz to 80 MHz, fi eld strengths should be less than 3 V/m.
b
A88091P00 AMP IFU_1_18_12.indd 16-17 A88091P00 AMP IFU_1_18_12.indd 16-17
Power frequency magnetic fi elds should be at levels
characteristic of a typical location in a typical
commercial or hospital environment.
Compliance Electromagnetic environment –
level guidance
Portable and mobile RF communications
equipment should be used no closer to any
part of the ECHELON FLEX Powered
Articulating Endoscopic Linear Cutter,
including cables, than the recommended
separation distance calculated from the
equation applicable to the frequency of
the transmitter.
Recommended separation distance
=
d 1 2 . P
Not applicable - Not Applicable
=
d 1 2 . P
80 MHz to 800 MHz
=
d 1 2 . P
3 V/m 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 fi xed RF transmitters,
as determined by an electromagnetic site
survey, should be less than the compli-
a
ance level in each frequency range.
Interference may occur in the vicinity of
equipment marked with the following
symbol:
16
Recommended separation distances between portable and mobile RF communications equipment
and the ECHELON FLEX Powered Articulating Endoscopic Linear Cutter
The ECHELON FLEX Powered Articulating Endoscopic Linear Cutter is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of the ECHELON FLEX Powered Articulating Endoscopic Linear Cutter
can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications
equipment (transmitters) and the ECHELON FLEX Powered Articulating Endoscopic Linear Cutter as recommended below, according to the
maximum output power of the communications equipment.
Rated maximum output power
of transmitter
W
0.01
0.1
1
10
100
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated
using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W)
according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and refl ection from
structures, objects and people.
b
Transport and Storage Conditions
Temperature: -22 ºC – 60 ºC
Relative Humidity: 10% – 80%
Pressure: 500 – 1060 hPa
How Supplied
The ECHELON families of endoscopic linear cutters are supplied sterile for single patient use. Discard after use.
Separation distance according to frequency of transmitter
m
150 kHz to 80 MHz 80 MHz to 800 MHz
= =
d 1 2 . P d 1 2 . P
Not applicable 0.12
Not applicable 0.37
Not applicable 1.17
Not applicable 3.69
Not applicable 11.67
17
800 MHz to 2,5 GHz
=
d 1 2 . P
0.23
0.74
2.33
7.38
23.33
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