8.3 Intended Use and Regulatory Statement
8.3.1 Intended Use
The RHINO2 scooter controller is intended to provide drive control for scooters that utilise a
single 24 V DC brushed motor fitted with a park brake, and seating control of 24 V DC
motor-driven actuators as fitted.
The controller will respond to user input demand in terms of direction (forward and
reverse), speed and seating actuator movement.
8.3.2 Device Classification
Europe
The RHINO2 Controller is a component of a Class I medical device as detailed in
EU Regulation 2017/745 on Medical Devices.
USA
The RHINO2 Controller is a component of a Class II medical device (Powered
Wheelchair) as detailed in 21 CFR § 890.3860.
The RHINO2 Controller is classified as 'wheelchair component' under 21 CFR
890.3920, Class1(General Controls), with Product Code KNN.
8.3.3 Compliance and Conformance with Standards
In accordance with the device classification, the RHINO2 scooter controller is designed to
enable the scooter manufacturer to comply with the relevant requirements of the European
Medical Device Regulation 2017/745 (MDR) and 21 CFR § 820.30.
The RHINO2 scooter controller has been designed such that the combination of the scooter
and controller, along with accessories as applicable, complies with the General Safety and
Protection Requirements of the MDR by adopting relevant clauses of regulatory standards
EN12184 and EN12182 and the FDA Consensus standard ANSI / RESNA WC-2:2009,
Section 21 for performance.
However, final compliance of the complete scooter system with international and national
standards is the responsibility of the scooter manufacturer or installer.
8.3.4 Programming Adapter
The programming adapter is intended to allow the RHINO2 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 24 V battery supply from the controller. The intended
environment is indoors or outdoors in dry conditions.
GBK51948 RHINO2
Installation Manual Issue 5
Appendices - Page 145
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