GBK65701 DX2 Compact Remote Modules
Installation Manual Issue 1
10.2.2 Intended use DX2-ACU
The DX2 Attendant Control Unit, DX2-ACU, is a component of the DX/DX2 System, intended to allow
attendants to interact with the System. The DX2-ACU allows the attendant to take control of drive
function, as configured and connected within the DX/DX2 System.
The DX2-ACU is not intended for use by users who cannot differentiate colours to accurately
determine the state of charge of the battery, where the DX2-ACU battery gauge is the sole means of
making this assessment.
10.2.3 Device classification
Europe
The DX2 compact remote modules DX2-RJM, DX2-RJM-LF and DX2-ACU are components
of a Class I medical device as detailed in the Council Directive 93/42/EEC concerning
Medical Devices.
USA
The DX2 compact remote modules DX2-RJM, DX2-RJM-LF and DX2-ACU are components
of a Class II medical device (Powered Wheelchair) as detailed in 21 CFR § 890.3860.
10.2.4 Compliance and conformance with standards
In accordance with the device classification, the DX2 compact remote module is 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 DX2 compact remote module has been designed such that the combination of the wheelchair
and controller, 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 for performance.
10.3 Service life
If the product has not been abused and all maintenance instructions as described in the maintenance
section have been properly followed, the expected service life (i.e. minimum serviceable life
expectancy) of the product is five (5) years. After this period, product reliability can no longer be
guaranteed and Dynamic Controls recommends the product is replaced for safety reasons. Dynamic
Controls accepts no responsibility/liability for product failure if the product is continued to be used
after the expected service life period has expired.
It is the OEM's responsibility to state the expected service life, as well as the inspection and
maintenance schedules for all modules and cables, including the DX communications bus loom.
10.4 Maintenance
The following instructions must be passed on to the operator before use of the product:
l
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 abra-
sive cleaners, as this may cause damage to the product.
l
Once a month, check all vehicle components for loose, damaged or corroded components,
such as connectors, terminals or cables. Ensure that all connectors are fully mated. Restrain all
Page 46 - Appendices