Intended Use And Regulatory Statement - Invacare Hydra C650PW Owner's Manual

7.3

Intended Use and Regulatory Statement

Intended Use
The Shark Control Unit and Power Module are intended to provide speed and
direction control for small or medium sized power wheelchair systems utilizing dual
DC motors and integrated park-brakes. The intended power source is a 24V battery.
The SHARK controller will respond to user input demand via the joystick input, in
terms of speed and direction.
The wheelchair manufacturers are provided with all the integration, set-up, operating
environment, test and maintenance information needed in order to ensure reliable
and safe use of the controller.
Device Classification
Europe
The SHARK Controller is a component of a Class I medical device as detailed
in the Council Directive 93/42/EEC concerning Medical Devices.
USA
The SHARK Controller is a component of a Class II medical device (Powered
Wheelchair) as detailed in 21 CFR § 890.3860.
Compliance and Conformance with Standards
In accordance with the device classification, the SHARK wheelchair controller is
designed to comply with the requirements of the European Medical Device Directive
93/42/EEC and 21 CFR § 820.30.
The SHARK Controller has been designed such that the combination of the
wheelchair and the SHARK Controller, along with accessories as applicable,
complies with the requirements of the MDD Harmonized standards EN12184 and
EN12182 and the FDA Consensus standard ISO 7176 for performance.
However, final compliance of the complete wheelchair system with international and
national standards is the responsibility of the wheelchair manufacturer or installer.
SHARK Programming Adapter
The Shark programming adapter is intended to allow the Shark Controller series of
power wheelchair controllers to communicate with the DX Hand Held Programmer
and the SHARK Support Tool. The adapter is not intended to alter the controller in
any way, but simply passes information to and from the controller. The information
passed may alter the controller performance.
The intended power source is a 24V battery supply from the Shark controller. The
intended environment is indoors, or outdoors in dry conditions.
Chapter 7 : Appendices
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