Blatchford LINX22L1S Manual Del Técnico Ortoprotésico página 36

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 any adverse outcome caused by any
component combinations that were not authorized by them.
CE Conformity
This product meets the requirements of the European Regulation EU 2017/745 for medical
devices. This product has been classified as a class I device according to the classification rules
outlined in Annex VIII of the regulation. The EU declaration of conformity certificate is available at
the following internet address: www.blatchford.co.uk
Medical Device Single Patient – multiple use
Compatibility
Combination with Blatchford branded products is approved based on testing in accordance
with relevant standards and the MDR including structural test, dimensional compatibility and
monitored field performance.
Combination with alternative CE marked products must be carried out in view of a documented
local risk assessment carried out by a Practitioner.
Warranty
This device is warranted for 36 months, the foot shell for 12 months, and the glide sock for 3
months.
Extended warranties of an additional 12, 24, or 36 months are available.
A service between 30 and 36 months is required for all extended warranties.
For the maximum 36-month extended warranty, a second service must be carried out between
54 and 60 months.
We reserve the right to void extended warranties if the device is not serviced at the required
intervals.
The user should be aware that changes or modifications not expressly approved could void the
warranty, operating licenses and exemptions.
The above may vary by market; consult your local representative for details.
See the Blatchford website for the current full warranty statement.
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