User Manual
Genie Joystick
Nov 07
©Unique Perspectives Ltd.
www.click2go.ie
Page 77
9
EC Declaration Of Conformity
Rationale
The Unique Perspectives Ltd. Genie Joystick device is designed for the
intended purpose of providing an alternative method of controlling the function of
a powered wheelchair. A wheelchair is considered a medical device as defined
within Council Directive 93/42/EEC concerning medical devices.
The Genie Joystick is designed for use in combination with a Controls Dynamic
DX control system, incorporates a DX UCM and uses a standard DXBUS
connector.
The Genie Joystick replaces the standard Controls Dynamic’s Joystick.
As the intended purpose is to control a powered wheelchair, and as the Genie
Joystick meets the definition of an “Accessory” of a medical device, as defined
at Article 1 paragraph 2 b) of the Directive, the Genie Joystick has been CE
marked as a medical device in accord with the Directive requirements.
Classification
The Unique Perspectives Ltd. Genie Joystick control system is intended to
provide an alternative operating / control system for those who would find it
difficult, painful, or impossible, due to an injury or handicap, to operate a
standard powered wheelchair control. It is intended to be used in combination
with Class I medical devices only.
The Genie Joystick is classified as a Class I device.
Compliance Certificate
The compliance certificate issued by Unique Perspectives Ltd. does not relieve
a wheelchair manufacturer from compliance testing their particular wheelchairs.
A manufacturers wheelchair must meet the requirements of the directive before
fitting of the Unique Perspectives Ltd. Genie Joystick.
As the Genie Joystick is an ‘Accessory’ to a medical device re-testing of a
manufacturer’s wheelchair with the Genie Joystick fitted is not a requirement.
Summary of Contents for Genie
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