Product Description; Contraindications; Intended Use - Ossur i-LIMB HAND Gebrauchsanweisung

ENGLISH
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
App control
Muscle control
Proximity control
Grips available
My grips
Speed boost
Powered thumb rotation
vari-grip
Natural hand mode
While digits are not controlled individually, automated grips allow the i-Limb hand user to move certain digits for
pinching an object or making a gesture. Training is required to fully utilize the i-Limb hand and fully understand all
the functional benefits.
INDICATIONS FOR USE
– Upper limb amputation
– Congenital upper limb absence

CONTRAINDICATIONS

None known.

INTENDED USE

The i-Limb hand is intended as a part of a prosthetic system that replaces function of a missing upper limb.
i-Limb Quantum
Yes
Yes
Yes
Yes
24
12
Yes
Yes
Yes
Yes
i-Limb Ultra
-
Yes
Yes
-
18
-
Yes
Yes
Yes
Yes
i-Limb Access
-
Yes
Yes
-
12
-
Yes
-
-
-
5