Product Compliance; Manufacturer's Declaration; Basicselectromagnetic Compatibility (Emc) - Covidien Nellcor Operator's Manual

Product Specifications

Product Compliance

11.8
Standards Compliance
Equipment Classifications
Type of Protection against electric shock
Degree of Protection against electric shock
Mode of Operation
Electromagnetic Compatibility
Liquid Ingress
Degree of Safety

Manufacturer's Declaration

11.9
Electromagnetic Compatibility (EMC)
11.9.1

WARNING:
The use of accessories, pulse oximetry sensors, and cables other than those
specified may result in inaccurate readings of the monitoring system and
increased emission of the monitoring system.

Caution:
For best product performance and measurement accuracy, use only
accessories supplied or recommended by Covidien. Use accessories according
to the Directions for Use. Use only accessories that have passed the
recommended biocompatibility testing in compliance with ISO10993-1.
The use of accessories, sensors, and cables other than those specified may
result in inaccurate readings of the monitoring system and increased emission
and/or decreased electromagnetic immunity of the monitoring system.
96
EN ISO 9919:2009, EN ISO 80601-2-61:2011
EN IEC 60601-1:2005
EN IEC 60601-1-2:2nd edition
EN IEC 60601-1:1998 + A1:1991 + A2:1995
EN 60601-1:1990 + A11:1993 + A12:1993 + A13:1996
CAN/CSA C22.2 No. 601.1 M90
UL 60601-1: 1st edition
Class I (internally powered)
Type BF - Applied part
Continuous
IEC 60601-1-2:2007
IPX2
Not suitable for use in the presence of flammable anesthetics
Operator's Manual