GBK62297 Issue 1, February 2003
7 Appendix
7.1Intended Use Statement
The DX-ARC-SWB is an accessory module intended to enable powered wheelchair users control of functions supported by the DX System, via ‘normally-open’ momentary switches of type and position determined by the installer.
Device Classification
The DX-ARC-SWB has been classified as a component of a Powered Wheelchair as detailed in 21 CFR § 890.3860 - Class II Medical Device.
The DX-ARC-SWB has been classified as a component of a Class I medical device as detailed in the Council Directive 93/42/EEC concerning Medical Devices.
Compliance and Conformance with Standards
DX-ARC-SWB has been designed such that the combination of the wheelchair controller and the DX-ARC-SWB conforms to the requirements of ISO7176. However, final conformity of the complete wheelchair system with international and national standards is the responsibility of the wheelchair manufacturer or installer. Further, national and international directives require confirmation of EMC compliance. Since EMC depends on the particular installation, compliance is the responsibility of the wheelchair manufacturer or installer.
Particular attention should be paid to the wheelchair controller installation manual(s) with respect to: -
Product Disclaimer
Electro Magnetic Compatibility
Maintenance
Safety & Misuse warnings
The selection and fail-safe operation of 3rd party equipment is the responsibility of the installer.