Guidance And Manufacturer's Declaration-Electromagnetic Emissions - Ethicon Echelon Flex PCEE45A Manual Del Usuario

Specifications
The ECHELON FLEX™ Powered Plus Articulating Endoscopic Linear Cutters have a power rating of 40 Watts.
The ECHELON FLEX™ Powered Plus Articulating Endoscopic Linear Cutters are resistant to water ingress and are classified per IEC 60601-1
as IPX0.
The ECHELON FLEX™ Powered Plus Articulating Endoscopic Linear Cutters need special precautions regarding EMC and need to be installed
and put into service according to the EMC information provided in this document. Portable and mobile RF communications equipment can affect
Medical Electrical Equipment.
WARNING: Use of any other type of battery other than the battery supplied with the device may result in increased EMISSIONS or decreased
IMMUNITY of the ECHELON FLEX™ Powered Plus Articulating Endoscopic Linear Cutters.
WARNING: Portable radio and mobile RF communications equipment can affect Medical Electrical Equipment. Follow the directions of the
following tables when using the ECHELON FLEX™ Powered Plus Articulating Endoscopic Linear Cutters.
WARNING: Avoid use of the ECHELON FLEX™ Powered Plus Articulating Endoscopic Linear Cutters adjacent to or stacked with other
equipment. If adjacent or stacked use is necessary, monitor the ECHELON FLEX™ Powered Plus Articulating Endoscopic Linear Cutters and the
other equipment to ensure normal operation.
Table of Toxic and Hazardous Substances / Elements and their Content
Product Codes: ECHELON FLEX™ POWERED ENDOPATH series
Part Name
Handle
Shaft
O: indicates that this toxic or hazardous substance contained in all of the homogenous materials for this part is below the limit requirement in
SJ/T11363-2006.
X: indicates that this toxic or hazardous substance contained in at least one of the homogeneous materials used for this part is above the limit
requirement in SJ/T11363-2006.
All parts named in this table are in compliance with the European union's RoHS legislation "Directive 2011/65/EU of the European Parliament
and of the Council of 8 June 2011 on the restriction of the use of hazardous substances in electrical and electronic equipment."
The referenced Environmental Protection Use Period Marking was determined according to normal operating conditions of the product such as
temperature and humidity.
Electromagnetic Emissions Guidance
Guidance and manufacturer's declaration—electromagnetic emissions
The ECHELON FLEX™ Powered Plus Articulating Endoscopic Linear Cutters are intended for use in the electromagnetic environment speci-
fied below. The customer or the user of the ECHELON FLEX™ Powered Plus Articulating Endoscopic Linear Cutters should ensure that they
are used in such an environment.
Emissions test
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
RF emissions
CISPR 14-1
As required by China's Management Methods for Controlling Pollution
By Electronic Information Products
Toxic and Hazardous Substances and Elements
Lead (Pb) Mercury Cadmium
(Hg) (Cd)
X O O
O O O
Compliance
Not applicable
The ECHELON FLEX™ Powered Plus Articulating Endoscopic Linear Cutter
is suitable for use in all establishments other than domestic and those directly
connected to the public low-voltage power supply network that supplies buildings
Not applicable
used for domestic purposes.
The ECHELON FLEX™ Powered Plus Articulating Endoscopic Linear Cutters are
Complies
not suitable for interconnection with other equipment.
Hexavalent Polybrominated
Chromiun biphenyls
(Cr(VI)) (PBB)
O O
O O
Electromagnetic environment - guidance
7
Polyrominated
diphenyl ethers
(PBDE)
O
O