Manufacturer's Declaration - Nellcor OxiMax N-600X Operator's Manual

Manufacturer's Declaration

N-600x Operator's Manual
Item
Year of manufacture symbol
Operation during physical
shock
Operation during vibration
Electromagnetic
Compatibility
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
Compliant With
EN 980
IEC 60068-2-27 at 100 g
IEC 60068-2-6 and IEC 60068-2-34
IEC 60601-1, sub clause 36, IEC/EN
60601-1-2 (second edition)
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.
Specifications
183