Codman ORBIT GALAXY G2 Información Importante página 6

Table 1 – Guidance and Manufacturer's Declaration – Emissions
All ME Equipment and ME Systems
Guidance and Manufacturer's Declaration - Emissions
The EnPOWER Detachment Control Box is intended for use in the electromagnetic
environment specified below. The customer or user of the EnPOWER DCB should ensure
that it is used in such an environment.
Emissions Test Compliance Electromagnetic Environment – Guidance
RF Emissions Group 1 The EnPOWER DCB uses RF energy only for its internal
CISPR 11 function. Therefore, its RF emissions are very low and are
not likely to cause any interference in nearby electronic
equipment.
RF Emissions Group 2 The EnPOWER DCB must emit Electromagnetic energy in
CISPR 11 order to perform its intended function. Nearby electronic
equipment may be affected.
RF Emissions Class B The EnPOWER DCB is suitable for use in all
CISPR 11 establishments, including domestic, and those directly
connected to the public low-voltage power supply network
that supplies buildings used for domestic purposes.
Harmonics N/A
IEC 61000-3-2
Flicker N/A
IEC 61000-3-3
Table 2 – Guidance and Manufacturer's Declaration – Immunity
All ME Equipment and ME Systems
Guidance and Manufacturer's Declaration – Immunity
The EnPOWER DCB is intended for use in the electromagnetic environment specified
below. The customer or user of the EnPOWER DCB should ensure that it is used in such
an environment.
Immunity Test IEC 60601 Test Compliance
Level Level
ESD ±6 kV Contact ±6 kV Contact
IEC 61000-4-2 ±8 kV Air ±8 kV Air
EFT ±1 kV I/Os ±1 kV I/Os
IEC 61000-4-4
Power 3 A/m 3 A/m
Frequency
50/60 Hz
Magnetic Field
IEC 61000-4-8
Electromagnetic Environment –
Guidance
Floors should be wood, concrete or
ceramic tile. If floors are synthetic,
the r/h should be at least 30%
Power frequency magnetic
fields should be that of a
typical commercial or hospital
environment.
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Table 3 – Guidance and Manufacturer's Declaration – Immunity
ME Equipment and ME Systems that are NOT Life-supporting
Guidance and Manufacturer's Declaration – Immunity
The EnPOWER Detachment Control Box is intended for use in the
electromagnetic environment specified below. The customer or user of the
EnPOWER DCB should ensure that it is used in such an environment.
Immunity Test IEC 60601 Compliance
Test Level Level
Conducted RF 3 Vrms (V1)=3 Vrms
IEC 61000-4-6 150 kHz to
(E1)=3 V/m
80 MHz
Radiated RF
IEC 61000-4-3 3 V/m
80 MHz to
2.5 GHz
Table 4 – Recommended Separation Distances between portable
and mobile RF Communications equipment and the EnPOWER
Detachment Control Box ME Equipment and ME Systems that are
NOT Life-supporting
Recommended Separations Distances for the EnPOWER
The EnPOWER DCB is intended for use in the electromagnetic environment
in which radiated disturbances are controlled. The customer or user of the
EnPOWER DCB can help prevent electromagnetic interference by maintaining
a minimum distance between portable and mobile RF Communications
Equipment and the EnPOWER DCB as recommended below, according to the
maximum output power of the communications equipment.
Max Output Separation (m) Separation (m)
Power (Watts) 150 kHz to 80 MHz 80 to 800 MHz
D=(3.5/V1)√P D=(3.5/E1)√P
0.01 0.11667 0.11667
0.1 0.36894 0.36894
1 1.1667 1.1667
10 3.6894 3.6894
100 11.667 11.667
Electromagnetic Environment –
Guidance
Portable and mobile
communications equipment should
be separated from the EnPOWER
DCB by no less than the distances
calculated/listed below:
D=(3.5/V1)√P 150kHz to 80MHz
D=(3.5/E1)√P 80 to 800 MHz
D=(7/E1)√P 800 MHz to 2.5 GHz
where P is the max power in
watts and D is the recommended
separation distance in meters.
Field strengths from fixed
transmitters, as determined
by an electromagnetic site
survey, should be less than the
compliance levels (V1 and E1).
Interference may occur in the
vicinity of equipment containing
a transmitter.
Separation (m)
800 MHz to 2.5 GHz
D=(7/E1)√P
0.23333
0.73785
2.3333
7.3785
23.333