Contraindications; Intended Use - Ossur i-LIMB WRIST Gebrauchsanweisung

ENGLISH
The i-Limb Wrist 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 should be read together with the i-Limb hand Technical
Manual.
The device may only be fitted by a qualified practitioner authorized by Össur after completing the corresponding
training.
These "Instructions for Use" relate to: i-Limb Wrist, digital electrodes, magnetic charger.
PRODUCT DESCRIPTION
The device is a powered wrist rotator enabling prepositioning of the wrist and hand in daily activities. It provides
simultaneous rotation of the wrist on grip selection when used together with the i-Limb Quantum hand.
Additionally, direct rotational control of the wrist is available.
The device can be used together with a proprietary control app for Apple iOS devices.
Each i-Limb Wrist is identified by a unique serial number. The serial number consists of a letter followed by six
numbers and is located on the rear end cap of the wrist rotator.
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.
REQUIRED DEVICES
The Biosim and My i-Limb mobile app require an Apple iOS device supported by the manufacturer, e.g. an iPhone
or iPad. See the Apple Store for device compatibility.
GENERAL SAFETY INSTRUCTIONS*
Warnings
i-Limb Wrist
– The end user is the intended operator of the device and is responsible for its use.
– Electrode may contain nickel.
– Do not disassemble componentry or modify in any way. This could void the user's authority to operate the
equipment.
– Do not service or perform maintenance.
– Do not use for heavy lifting.
– Do not use with machinery with moving parts that may cause personal injury or damage.
– Do not use for extreme activities that may cause injury to a natural hand.
– Do not expose to vibration.
– Do not expose to excessive or high forces.
– Do not expose to water.
– Do not expose to excessive moisture, liquids, dust, high temperatures, or shock.
– Do not use in hazardous environments.
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