Abilia GEWA Connect, User Manual, Page: 38 / 40

Important information
38
Serious incidents
If a serious incident related to the product occurs, this must be reported to the
manufacturer and the competent authority of your country. An incident is
regarded serious if it directly or indirectly led, might have led or might lead to
either of these situations:
l
The death of a patient, user or other person.
l
The temporary or permanent serious deterioration of a patient's, user's or
other person's state of health.
l
A serious public health threat.
Conformance with requirements for medical devices
GEWA Connect is marketed as a technical aid for people with disabilities. It
complies with all necessary requirements, regulations and directives for
medical devices.
Product liability
The product has been developed and risk-assessed in accordance with ISO
14971. The user manual and the technical specifications are made according
to the safety assessments in the risk analysis. Always consider the safety
when using the product. If the product is used in other ways than the intended
use, it may involve risks for which Abilia AB does not take responsibility. The
estimated life of the product applies when used in accordance with its intended
use and maintenance instructions.
Abilia AB is not liable for any loss, damage or consequential loss if the product
has been used or installed in any way other than as specified in this document.
Any form of damage or tampering with the product invalidates the warranty
and disclaims the manufacturer's liability.
Registered trademarks
The Bluetooth® word mark and logos are registered trademarks owned by
Bluetooth SIG, inc. and any use of such marks by Abilia AB is under license.