General
Thank you for choosing an Etac device.
This manual must be read thoroughly before you start using the device as it contains important safety
information and gives instructions on how to use the device correctly. Visit www.etac.com for all relevant
product documentation, for example the user manual, maintenance and recycling instructions. You can
select your language via the "International" and "Local websites" link.
You can also consult the QR code on the device for further information and instructions.
Copyright
This document is the property of Etac A/S. The con-
tent shall not be modified in whole or part without
prior approval of Etac A/S.
Disclaimer
Etac continuously makes improvements to our de-
vices and information. We therefore reserve the
right to modify our devices and instructions for use
without prior notice. Consult www.etac.com to find
the latest version of the documentation.
Declaration of Conformity
The device mentioned in this manual and the dif-
ferent models hereof comply with the Medical De-
vice Regulation (EU) 2017/745.
The device is classified as a Class I medical device.
Product standards
The device has been tested and complies with the
requirements applicable for this type of device in
the below mentioned standards:
• ISO 21856:2022 Assistive products — General
requirements and test methods.
ENGLISH
Warranty
Please refer to www.etac.com/support.
If the customer makes adjustments, repairs or
uses combinations not predetermined by Etac, the
Etac CE certification and Etac warranty will not be
valid. If in doubt, please contact Etac.
Notice
Any serious incident that has occurred in relation
to the device should be reported to your distri-
butor/representative and the national competent
authority within your region in a timely manner.
The distributor/representative will forward the
information to the manufacturer.
Pre-sales information
Please visit www.etac.com.
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BM62099 Rev. 1.0