Blatchford Elite2 Instrucciones De Uso página 14

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
Single Patient – multiple use
Medical Device
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 - foot shell 12 months - glide sock 3 months.
The user should be aware that changes or modifications not expressly approved could void the
warranty, operating licences and exemptions.
See Blatchford website for the current full warranty statement.
Reporting of Serious Incidents
In the unlikely event of a serious incident occurring in relation to this device it should be
reported to the manufacturer and your national competent authority.
Environmental Aspects
Where possible the components should be recycled in accordance with local waste handling
regulations.
Retaining the Packaging Label
You are advised to keep the packaging label as a record of the device supplied.
Manufacturer's Registered Address
Blatchford Products Limited, Lister Road, Basingstoke RG22 4AH.
Trademark Acknowledgements
Elite Foot and Blatchford are registered trademarks of Blatchford Products Limited.
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