Blatchford Elan ELAN22L1S, User Manual

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11
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
Warranty
The Elan is warranted for – 36 months – foot shell 12 months - glide sock 3 months.
See Blatchford website for the current full warranty statement.
Scheduled service every 20 months is required, for maintenance of the warranty.
For extended warranty contact service provider.
The user should be aware that changes or modifications not expressly approved could void the
warranty, 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: T9J-RN41-1
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.
Medical Device
Single Patient – multiple use
938318SPK3/1-0321