Blatchford Detachable Cosmetic Cover Instrucciones De Uso página 4

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
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.
Manufacturer's Registered Address
Blatchford Products Limited, Lister Road, Basingstoke RG22 4AH, UK.
Trademark Acknowledgements
Blatchford is a registered trademark of Blatchford Products Limited.
Single Patient –
multiple use
Warranty
This device is warranted for 6 months. The user
should be aware that changes or modifications
not expressly approved could void the
warranty, operating licenses and exemptions.
See the 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
This product is fabricated from a polyurethane
that cannot be easily recycled: please dispose
of it responsibly as general waste, as per local
handling regulations.
Retaining the Packaging Label
The practitioner is advised to keep the
packaging label as a record of the device
supplied.
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