Dynamic DX-REMG91, Руководство по установке

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Chapter 9: Appendices 67
9.3 Intended Use and Regulatory Statement
Intended Use
The DX-REMG91 family are components of a DX system intended to allow powered
wheelchair users interaction with the DX System. The DX-REMG91 offers flexibility in integrating
compatible input and output devices, as configured and connected and provides extensive
adaptability to meet specific user needs through optimal programmability.
The DX system is intended to operate powered wheelchairs utilizing 24V motors with
integrated park-brakes.
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 DX Controller is a component of a Class I medical device as detailed in the
Council Directive 93/42/EEC concerning Medical Devices.
USA
The DX 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 DX wheelchair controller is designed to
comply with the requirements of the European Medical Device Directive 93/42/EEC and 21
CFR § 820.30.
The DX Controller has been designed such that the combination of the wheelchair and the
DX 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.