VISIOMED OXYcheck VM-300C18 Manual De Utilización página 19

DECLARATION
Guidance and Manufacturer's declaration – electromagnetic emissions-
For all EQUIPMENT and SYSTEMS. Guidance and Manufacturer's declara-
tion - electromagnetic emission
The VM-300C18 Pulse Oximeter is intended for use in the electromagnetic
environment specified below. The customer or the user of VM-300C18 Pulse
Oximeter should assure that it is used in such an environment.
Emission test Compliance
RF emissions CISPR 11 Group 1
RF emissions CISPR 11 Class B
Harmonic emissions
Not Applicable
IEC 61000-3-2
Voltage fluctuations/flicker
Not Applicable
emissions IEC 61000-3-3
Guidance and Manufacturer's declaration – electromagnetic emissions-
For all EQUIPMENT and SYSTEMS. Guidance and Manufacturer's declara-
tion - electromagnetic emission
The VM-300C18 Pulse Oximeter is intended for use in the electromagnetic
environment specified below. The customer or the user of theVM-300C18
Pulse Oximeter should assure that it is used in such an environment.
Immunity IEC 60601 Compliance
test test level Level
Electrostatic
+/- 6kV +/- 6kV
Discharge
contact contact
(ESD)
+/- 8kV air +/- 8kV air
IEC 61000-4-2
Electromagnetic
Environment – guidance
The VM-300C18 Pulse Oximeter
uses RF energy only for its internal
function. Therefore, its RF emis-
sions are very low and are not
likely to cause any interference in
nearby electronic equipment.
The pulse Oximeter (VM-300C18)
is suitable for use in all establish-
ments, including domestic
establishments and those directly
connected to the public low-
voltage power supply network
that supplies buildings used for
domestic purposes.
Electromagnetic
Environment – guidance
Floors should be wood, concrete
or ceramic tile. If floor are covered
with synthetic material, the relative
humidity should be at least 30%.
Power
frequency
(50/60 Hz) 3A/m 3A/m
magnetic field
IEC 61000-4
Guidance and Manufacturer's declaration – electromagnetic immunity-
For all EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING. Gui-
dance and Manufacturer's declaration - electromagnetic immunity
The VM-300C18 Pulse Oximeter is intended for use in the electromagnetic
environment specified below. The customer or the user of theVM-300C18
Pulse Oximeter should assure that it is used in such an environment.
Immunity Compliance
IEC
test Level
Portable and mobile RF communications
equipment should be used no closer to any
part of the Pulse Oximeter (VM-300C18),
including cables, than the recommended
separation distance calculated from the
equation applicable to the frequency of
the transmitter.
Recommended separation distance :
d=
Radiated d=
RF
Where P is the maximum output power
IEC 3 V/m 3 V/m
rating of the transmitter in watts (W) ac-
61000-
cording to the transmitter manufacturer
4-3
and d is the recommended separation
distance in meters (m).
Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
survey, should be less than the compliance
level in each frequency range. b
Interference may occur in the vicinity of
equipment marked with following symbol :
Power frequency magnetic fields
should be at levels character-
istics of a typical location in a
typical commercial or hospital
environment.
Electromagnetic
Environment – guidance
1.2 P √
80 MHz to 800 MHz
2.3 P √
800 MHz to 2.5 GHz