Instructions For Use; Indications For Use; Intended Use - Össur i-Digits Quantum Instrucciones Para El Uso

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
Control options
App control Yes
Muscle control Yes
Proximity control Yes
Gesture control Yes
Grips available
My grips

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.
i-Digits Quantum
20
12
i-Digits France
Yes
Yes
Yes
-
12
-
i-Digits Access
Yes
Yes
-
-
12
-
7