Compliance; Product-Specific Standards; Usability - Invacare AVIVA FX Series User Manual

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Invacare® AVIVA™ FX Series
Gives useful tips, recommendations and
information for efficient, trouble-free use.
Identifies required tools, components and items
which are needed to carry out certain work.
Other Symbols
(Not applicable for all manuals)
UK Responsible Person
Indicates if a product is not manufactured in
the UK.
Triman
Indicates recycling and sorting rules (only
relevant for France).

1.3 Compliance

Quality is fundamental to the company's operation, working
within the disciplines of ISO 13485.
This product features the CE mark, in compliance with the
Medical Device Regulation 2017/745 Class I.
This product features the UKCA mark, in compliance with
Part II UK MDR 2002 (as amended) Class I.
We are continuously working towards ensuring that the
company's impact on the environment, locally and globally,
is reduced to a minimum.
We only use REACH compliant materials and components.
We comply with the current environmental legislations
WEEE and RoHS.
6

1.3.1 Product-Specific Standards

The product has been tested and conforms to EN 12184
(Electrically powered wheelchairs, scooters and their
chargers) and all related standards.
When equipped with an appropriate lighting system, the
product is suitable for use on public roads.
For further information about local standards and
regulations, contact your local Invacare distributor. See
addresses at the end of this document.

1.4 Usability

Only use a mobility device when it is in perfect working
order. Otherwise, you might put yourself and others at risk.
The following list does not claim to be exhaustive. It is only
intended to show some of the situations that could affect
the usability of your mobility device.
In certain situations, you should immediately stop using
your mobility device. Other situations allow you to use the
mobility device to get to your provider.
You should immediately stop using your mobility device if
its usability is restricted due to:
Unexpected driving behaviour
brake failure
You should immediately contact an authorised Invacare
provider if the usability of your mobility device is restricted
due to:
the lighting system (if fitted) failing or being defective
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