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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:
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 24 months, the brake band for 12 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 symbol indicates that the product contains electrical/electronic components
and/or batteries that should not be disposed of in general waste or be incinerated at
the end of the product’s life.
At the end of the product’s life, all electrical/electronic components and/or batteries
should be recycled or disposed of in accordance with the current regulations for the
handling of WEEE (Waste Electrical and Electronic Equipment), or equivalent local
regulations. The remainder of the product should also be recycled where possible in accordance
with local waste recycling regulations.
To help prevent potential harm to the environment or to human health from uncontrolled waste
disposal, Blatchford offers a take-back service. Please contact Customer Services for details.
Retaining the Packaging Label
The practitioner is advised to keep the packaging label as a record of the device supplied.
Single Patient – multiple use
Medical Device
938250PK2/1-0421
