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Ossur i-Limb Quantum User Manual

Ossur i-Limb Quantum
359 pages
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i  LIMB
®
HAND
Instructions for Use

Table of Contents

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Ossur i-Limb Quantum Specifications

General IconGeneral
ManufacturerÖssur
TypeProsthetic hand
ControlMyoelectric
Gesture ControlYes
VariGripYes
ConnectivityBluetooth
Grip PatternsMultiple grip patterns
Grip OptionsCustomizable grips
my i-Limb AppYes
Number of electrodesMultiple
WeightVaries by size
Battery LifeVaries by usage
Water ResistanceSplash resistant (not fully waterproof)

Summary

REGULATORY MARKINGS

Consult instructions for use

Provides guidance on consulting the product's instructions for proper use and safety.

Class II equipment

Indicates double isolation for protection against electric shock.

IP22

Specifies protection against solid objects >12.5mm and splashing water.

Serial Number

Unique identifier for i-limb devices, starting with M, U, or A.

WEEE Compliance

Guidance on responsible disposal of electronic components and batteries.

Manufacturer and year of manufacturing

Identifies the manufacturer and the year the product was made.

European Conformity

Indicates compliance with EU safety, health, and environmental protection requirements.

BF Applied Part

Designates the part of the equipment connected to the patient.

I-LIMB HAND OPERATION

Product Description

Details the i-Limb hands as prosthetic devices with motorized digits and control app.

Indications for Use

Specifies that the device is for individuals with upper limb absence.

Contraindications

States that no contraindications are currently known for the device.

Intended Use

Defines the intended application for individuals with upper limb absence.

REQUIRED DEVICES

Description

Lists necessary software applications for controlling the i-Limb hand.

SAFETY INSTRUCTIONS

Warnings

Lists critical warnings for i-Limb hand and battery usage to prevent injury or damage.

Precautions

Outlines necessary precautions for safe operation, maintenance, and accessory use.

SAFE USE GUIDELINES

Description

Provides instructions on how to hold and manipulate objects securely with the i-Limb hand.

POWER MANAGEMENT

Magnetic Charging Port

Details the function of the magnetic charging port for power management.

Turning the Device On and Off

Explains the procedure for powering the i-Limb hand on and off.

BATTERY MANAGEMENT

Checking the Battery Charge Level Status

Describes how to interpret the battery charge level indicators.

Charging the battery

Provides instructions and warnings for charging the i-Limb hand battery.

External Battery

Instructions for charging separate external batteries using the charger base unit.

Power Supply

Specifies the approved power supply for charging Össur batteries.

CONTROLLING THE I-LIMB HAND

Identifying the Device Number

Explains how to find and connect the device number to the control app.

Gesture Control

Details how to activate grips using specific hand movements.

App Control

Explains accessing automated grips via the My i-Limb mobile application.

Muscle Control

Describes using muscle signals to trigger specific grip patterns.

Proximity Control

Explains using Grip Chips to change hand function based on proximity.

I-LIMB HAND COVERS

Donning a Cover

Step-by-step guide on how to put on the i-Limb hand covers.

Donning the i-Limb Skin Match cover

Specific instructions for donning the i-Limb Skin Match cover using isopropyl alcohol.

Doffing all Covers

Instructions for removing i-Limb hand covers.

CLEANING

Description

Provides instructions for cleaning the i-Limb hand, its components, and accessories.

TECHNICAL SPECIFICATIONS

Description

Lists key technical data including voltage, current, capacity, load limits, and service life.

LIST OF PARTS

i-Limb Quantum

Catalog of part codes and descriptions for the i-Limb Quantum series.

i-Limb Ultra

Catalog of part codes and descriptions for the i-Limb Ultra series.

i-Limb Access

Catalog of part codes and descriptions for the i-Limb Access series.

LIST OF MAIN COMPONENTS

Description

Lists key components with their respective part codes and descriptions.

ENVIRONMENTAL CONDITIONS

Description

Specifies operational and storage conditions for temperature, humidity, and pressure.

BLUETOOTH MODULES REGULATED INFORMATION

Description

Technical details regarding the device's Bluetooth transmitters and regulatory compliance.

ELECTROMAGNETIC COMPATIBILITY

Description

General warnings and guidelines for ensuring proper EMC performance.

ELECTROMAGNETIC EMISSIONS GUIDANCE

Description

Provides guidance on electromagnetic emissions and their compliance levels.

ELECTROMAGNETIC IMMUNITY GUIDANCE

Description

Provides guidance on immunity to various electromagnetic disturbances and compliance levels.

RF SEPARATION DISTANCES

Description

Specifies recommended separation distances for RF equipment to prevent interference.

DISPOSAL

Description

Provides instructions for the environmentally sound disposal of the product and packaging.

GENERAL CAUTIONS AND DISCLAIMERS

Description

General cautions regarding product design, testing, and single-patient use.

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