Dynamic DX-RJM-HD, Руководство по установке

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5 Appendices
5.1 Intended use and regulatory statement
Intended use
The DX-RJM-HD is a DX Secondary Remote, utilising a robust switched joystick, intended for powered
wheelchair users who could damage a standard joystick. The DX-RJM-HD is a module of the DX
System, intended to allow users interaction with the DX System.
The DX System is intended to operate powered wheelchairs utilising 24 V motors with integrated park
brakes.
The wheelchair manufacturers are provided with the integration, set-up, operating environment, test
and maintenance information needed to ensure reliable and safe use of the DX System.
Device classification
Europe
The DX-RJM-HD is a component of a Class I medical device as detailed in the Council
Directive 93/42/EEC concerning Medical Devices.
USA
The DX-RJM-HD 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-RJM-HD has been designed to enable the
wheelchair manufacturer to comply with the relevant requirements of the European Medical Device
Directive 93/42/EEC and 21 CFR § 820.30.
The DX-RJM-HD has been designed such that the combination of the wheelchair and the DX System,
along with accessories as applicable, complies with the Essential Requirements of the MDD by
adopting relevant clauses of harmonised standards EN12184 and EN12182 and relevant parts of the
FDA Consensus standard ANSI/RESNA WC-2:2009, Sections 9, 14 and 21 for performance.
5.2 Maintenance
1. Keep all Dynamic Controls' electronic components free of dust, dirt and liquids. To clean the
product, use a cloth dampened with warm soapy water. Do not use chemicals, solvents or
abrasive cleaners, as this may cause damage to the product.
2. Regularly check all vehicle components for loose, damaged or corroded components, such as
connectors, terminals, or cables. Restrain all cables to protect them from damage. Replace
damaged components.
3. Regularly test all switchable functions on the Dynamic Controls' electronics system to ensure
they function correctly.
4. There are no user-serviceable parts in any Dynamic Controls' electronic component. Do not
attempt to open any case or undertake any repairs, else warranty will be voided and the safety
of the system may be compromised.
5. Where any doubt exists, consult your nearest service centre or agent.
GBK59690 DX Heavy Duty Switch Joystick
Installation Manual Issue 5
Appendices - Page 11