Chapter 6: Appendices
120
6.3
Intended Use and Regulatory Statement
Intended Use
The
R
HINO
2
scooter controller is intended to provide speed control for small, medium or large
sized scooters that utilise a single 24V DC brushed motor and integrated park brake. The
R
HINO
2
with Seat Lift (DS90-ACT, DS120-ACT and DS160-ACT) controllers are also fitted with a
seat actuator control that is used to adjust seat height through a DC motor driven seat
actuator.
The controller will respond to user input demand via an analogue input in terms of direction
(forward and reverse), speed, seat extend and seat retract.
The scooter 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
R
HINO
2
Controller is a component of a Class I medical device as detailed in the
Council Directive 93/42/EEC concerning Medical Devices.
USA
The
R
HINO
2
Controller is a component of a Class II medical device (Powered
Wheelchair) as detailed in 21 CFR § 890.3860.
The
R
HINO
2
Controller is classified as 'wheelchair component' under 21 CFR 890.3920,
Class 1(General Controls), with Product Code KNN.
Compliance and Conformance with Standards
In accordance with the device classification, the
R
HINO
2
scooter controller is designed to
enable the scooter manufacturer to comply with the relevant requirements of the European
Medical Device Directive 93/42/EEC and 21 CFR § 820.30.
The
R
HINO
2
scooter controller has been designed such that the combination of the scooter
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 the FDA Consensus standard ANSI/RESNA 7176 for performance.
However, final compliance of the complete scooter system with international and national
standards is the responsibility of the scooter manufacturer or installer.
Programming Adapter
The programming adapter is intended to allow the
R
HINO
2
scooter controllers the ability to
communicate with the Wizard and the DX Hand Held Programmer. The adapter is not
intended to alter the controller in any way, but simply passes information to and from the
controller. The information passed may alter the controller performance.
The intended power source is a 24V battery supply from the controller. The intended
environment is indoors or outdoors in dry conditions.
6.4
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