Manufacturer's Declaration - Nellcor OxiMax N-600x Service Manual

Declaration
Manufacturer's
O M N-600x Service Manual
XI AX
WARNING: The use of accessories, O
those specified may result in increased emission and/or decreased immunity
of the N-600x pulse oximeter.
Table 16:
The N-600x is suitable for use in the specified electromagnetic environment. The
customer and/or user of the N-600x should assure that it is used in an electromagnetic
environment as described below:
Emissions Test
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/
flicker emission
IEC 61000-3-3
Table 17: Electromagnetic Immunity
The N-600x is suitable for use in the specified electromagnetic environment. The
customer and/or user of the N-600x should assure that it is used in an electromagnetic
environment as described below.
Immunity IEC 60601-1-2
Test Test Level
Electrostatic ± 6 kV contact
discharge (ESD)
± 8 kV air
IEC 61000-4-2
Note: U is the AC mains voltage prior to application of the test level.
T
M sensors, and cables other than
XI AX
Electromagnetic Emissions
Electromagnetic Environment
Compliance
Guidance
Group 1 The N-600x must emit electromagnetic
energy in order to perform its intended
function. Nearby electronic equipment
may be affected.
Class B The N-600x is suitable for use in all
establishments.
Complies
Complies
Compliance
Level
± 6 kV contact
± 8 kV air
Specifications
Electromagnetic
Environment
Guidance
Floor should be wood,
concrete, or ceramic tile. If
floors are covered with
synthetic material, the
relative humidity should
be at least 30 %.
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