Instructions For Use; Contraindications; Intended Use - Ossur i-LIMB Hand Gebrauchsanweisung

INSTRUCTIONS FOR USE

I-LIMB HAND
The i-Limb hand 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 the user of the device. The device may only be
configured and fitted by a qualified practitioner authorized by Össur after completing the corresponding training.
These "Instructions for Use" relate to: i-Limb Quantum, i-Limb Ultra, i-Limb Access, analog electrodes, magnetic
charger port, mains and car charger.
PRODUCT DESCRIPTION
The i-Limb hands are a range of prosthetic hands consisting of individual motorized digits, stall detection and
a proprietary control app for Apple iOS devices (Fig. 1a). The product label can be found on the side of the device.
(Fig. 1b). The device is assembled as part of your prosthesis together with a socket custom made for you by your
clinician.
Users can choose from a selection of automated grips and gestures to help complete their daily tasks. Depending
on model, grips can be customized and automated for additional control. An overview of available control options
can be found in the features comparison table below:
Features comparison
Control options
Gesture control Yes
App control Yes
Muscle control Yes
Proximity control Yes
Grips available
My grips
Speed boost
Powered thumb rotation
Vari-grip
Natural hand mode
While digits are not controlled individually, automated grips allow i-Limb hands users to move certain digits for
pinching an object or make a gesture. Training is required to fully utilize the i-Limb hand and fully understand all
the functional benefits.
INDICATIONS FOR USE
Individuals with upper limb absence.

CONTRAINDICATIONS

None known.

INTENDED USE

Individuals with upper limb absence with the potential to use an upper limb prosthesis.
i-Limb Quantum
24
12
Yes
Yes
Yes
Yes
i-Limb Ultra
-
Yes
Yes
-
18
-
Yes
Yes
Yes
Yes
i-Limb Access
-
Yes
Yes
-
12
-
Yes
-
-
-
6