Invacare Hydra C650PW, Руководство пользователя

Страница: 119 / 126

GBK80262 : Issue 1 – 1/07/2004
32
DX Batteries to SHARK Controller
Adapter Loom (175mm) GSM80201 1
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