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endolite Orion3 Guide De L'utilisateur page 11

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  • FRANÇAIS, page 12
The user should be aware that changes or modifications not expressly approved
could void the operating licences and exemptions.
This device complies with part 15 of the FCC Rules.
Operation is subject to the following three conditions:-
1) This device may not cause harmful interference.
2) This device must accept any interference received, Including interference that
may cause undesired operation.
3) Contains pre-approved Bluetooth module:
FCC ID: PVH0946 IC: 5325A-0946
Liability
The manufacturer recommends using the device only under the specified conditions
and for the intended purposes. The device must be maintained according to the
instructions for use supplied with the device. The manufacturer is not liable for damage
caused by the component combinations that were not authorized by the manufacturer.
CE Conformity
This product meets the requirements of 93/42/EEC guidelines for medical products.
This product has been classified as a Class 1 Product according to the classification
criteria outlined in Appendix IX of the guidelines. The Declaration of Conformity was
therefore created by Blatchford Products Limited with sole responsibility according to
Appendix VII of the guidelines.
Warranty
The warranty for the Orion3 knee is 36 months.
A scheduled service is required every 20 months.
See Endolite website for current full warranty statement.
Extended additional warranty for the Orion3 is available on request contact service
provider.
The user should be aware that changes or modifications not expressly approved will
void the warranty.
Blatchford Products Ltd. and ENDOLITE are companies and trademarks of Chas. A. Blatchford and Sons Ltd.
938375/1-0816
9

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