23
Appendices
6
Appendices
6.1
Intended use and regulatory statement
Intended Use
The iPortal is a one-way communication module intended to provide an interface to third
party communication devices that serve as an optional display for a D
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wheelchair control system. The iPortal is intended for wheelchair users who have difficulty
viewing the display or interface on the regular D
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Remotes and would benefit
from a heads up display of visual feedback on the operational state of the wheelchair
control system. It is not intended to operate diagnostic or life support devices or similar safety
critical applications.
Additionally, the iPortal offers users who have little or no ability to directly operate an iDevice
(iPhone, iPod), the functionality to navigate and control these devices through the
wheelchair control system.
Regulatory Classification
Europe
The iPortal is an optional output display from either the Shark System or the DX/DX2
System, classified as an accessory of a Class I medical device (Powered Wheelchair)
as detailed in Directive 93/42/EEC concerning Medical Devices (as amended by
Council Directive 2007/47/EC).
USA
The iPortal is an optional output display from the Shark System or DX-System, classified
as an accessory of a Class II medical device (Powered Wheelchair) as detailed in 21
CFR § 890.3860. Accordingly, the iPortal is itself categorized as a 'wheelchair
accessory' as detailed in 21 CFR § 890.3910 - Class I, 510(k) exempt.
Compliance and Conformance with Standards
In accordance with the regulatory classification, the iPortal is designed to comply with the
requirements of the European Council Directive 93/42/EEC and US Quality System
Regulations of 21 CFR § 820.
The iPortal has been designed such that the combination of the wheelchair and the control
system (Shark System or DX/DX2 System) including the iPortal - but excluding the third party
display equipment - complies with the requirements of the MDD Harmonized Standards
EN12184 and EN12182 and the FDA Consensus Standard ANSI/RESNA 7176 for performance.
6.2
Service life
If the product has been installed, used and maintained as recommended, all instructions
contained in this manual have been properly followed, and the unit has not been abused,
the expected service life period (i.e. serviceable life expectancy) of the product is five (5)
years. After this period, D
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recommends the product be replaced for safety
reasons. D
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accepts no responsibility or liability for product failure if the
product is retained in use beyond the stated service life period.
