Össur i-Digits Quantum, Техническое руководство

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INSTRUCTIONS FOR USE
I-DIGITS
The i-Digits is referred to as “the device” in the following document. This document provides information on the
indications for use, and handling of the device. It is intended for a certified clinician. The device may only be fitted
and configured by a qualified practitioner authorized by Össur after completing the corresponding training.
These “Instructions for Use” relate to: i-Digits Quantum, i-Digits Access, i-Digits France, analog electrodes, mains
and car charger.
PRODUCT DESCRIPTION
i-Digits is a fully customized partial hand prosthesis with individually powered digits. i-Digits move independently
and work in conjunction with remaining fingers
(Fig. 1a) . The product label can be found on the wristband (Fig. 1b) .
i-Digits Quantum has 20 different grip options available and 12 customizable my grips. All other i-Digits devices
have 12 grip options available. The grips can be accessed and programmed through the Biosim or My i-Limb app.
The available grips for the device are displayed on the quick grips page of the Biosim or My i-Limb app.
Features comparison
i-Digits Quantum i-Digits France i-Digits Access
Control options
App control Yes Yes Yes
Muscle control Yes Yes Yes
Proximity control Yes Yes -
Gesture control Yes - -
Grips available 20 12 12
My grips 12 - -
INDICATIONS FOR USE
Individuals with upper limb absence. Absence of 1-5 digits, distal to the wrist and proximal to the
metacarpophalangeal joint.
CONTRAINDICATIONS
None known.
INTENDED USE
Individuals with upper limb absence with the potential to use an upper limb prosthesis.
REQUIRED DEVICES
The Biosim and the My i-Limb mobile app requires an Apple iOS device supported by the manufacturer, e.g. an
iPhone or iPad. See the Apple Store for device compatibility.