Manufacturer's Declaration - Covidien Nellcor OxiMax N-600x Operator's Manual

Specifications

Manufacturer's Declaration

174
Item
Radiated and conducted
emissions
Operation with electrical line
voltage variations
Magnetic field susceptibility
WARNING: The use of accessories, sensors, and cables other
than those specified may result in increased emission and/
or decreased immunity of the N
Table 17: Electromagnetic Emissions
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 Compliance
RF emission Group 1
CISPR 11
RF emissions Class B
CISPR 11
Harmonic Complies
emissions
- -
IEC 61000 3 2
Voltage Complies
fluctuations/
flicker emission
- -
IEC 61000 3 3
Compliant With
EN 55011, Group 1, Class B
FDA Reviewer's Guide
RS 101 in MIL-STD-461E
600x pulse oximeter.
-
Electromagnetic
Environment Guidance
-
The N 600x uses RF only for its
internal function.
-
The N 600x is suitable for use in
all establishments.
N-600x Operator's Manual