Dynamic iPortal 2, Руководство по установке

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23 GBK52981 iPortal2 Installation Manual Appendices
8 Appendices
8.1 Intended use and regulatory statement
Intended Use
The iPortal2 is a one-way communication module intended to provide an interface between
a Dynamic Controls wheelchair control system and third party communication devices that
serve as an optional display, as well as the ability to operate a mobile technology device
through the wheelchair controls. The iPortal2 is intended for wheelchair users who have
difficulty viewing the display or interface on the regular Dynamic Controls Remotes and
would benefit from a heads up display of visual feedback on the operational state of the
controller system.
It is not intended to operate diagnostic or life support devices or similar safety critical
applications.
Additionally, the iPortal2 offers users who have little or no ability to directly operate an
iDevice (iPhone, iPod Touch, iPad) or personal computer with Bluetooth connectivity
(Windows PC or Mac), the functionality to navigate and control features and functions of an
iOS, Android or Windows based device through the wheelchair control system.
Regulatory Classification
 Europe
The iPortal2 is an optional output display from either the Shark System or the DX/DX2
System, with functionality to navigate and control an iOS, Android or Windows
device, 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 iPortal2 is an optional output display from the Shark System or DX-System, with
functionality to navigate and control an iOS, Android or Windows device, classified as
an accessory of a Class II medical device (Powered Wheelchair) as detailed in 21
CFR § 890.3860. Accordingly, the iPortal2 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 iPortal2 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 iPortal2 has been designed such that the combination of the wheelchair and the control
system (Shark System or DX/DX2 System) including the iPortal2
– but excluding the third party
display equipment – complies with the relevant clauses of the MDD Harmonized Standards
EN12184 and EN12182 and applicable parts of the FDA Consensus Standard ANSI/RESNA
7176 for performance.
8.2 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)