touch bionics i-limb digits User Manual

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i-limbTM digits
User Manual
Part number: MA01063: Issue No. 1, December 2012
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This symbol signies important information and is used throughout the manual.
Refer to www.touchbionics.com to ensure the latest copy of this document.
Part number: MA01063: Issue No. 1, December 2012
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Table of Contents
1 i-limb digits 1.1 Product Description
1.2 Know Your Prosthesis
1.3 Wristband
2 Socket Interface 2.1 Socket Interface and Electrodes
2.2 Battery
2.3 Battery Charging
3 biosim 3.1 biosim Overview
3.2 biosim Connecting
3.3 Navigating biosim
3.3.1 Features
3.3.2 Training
3.3.3 Hand Health Check
3.3.4 Exit
4 i-limb digits Coverings 4.1 Cover Options
5 Support Information 5.1 Troubleshooting
5.2 Warnings and Precautions
6 User Information 6.1 User Details
7 Appendix 7.1 Technical Information
7.2 Component Compatibility
7.3 Warranty
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1.0 i-limb digits
1.1 Product Description
i-limb digits is a customized prosthetic device designed to
t and function with your residual hand. i-limb digits is a tool to enhance function for individuals with partial hand loss or deciency.
Each digit in the system has its own motor, which allows the i-limb digits to take the shape of whatever object is being held. This also allows you to stop a digit or multiple digits from moving by putting pressure against the digit to stop its motion. Additionally, different grasp patterns can then be programmed into the hand using a software system called biosim.
These various grasping patterns will be discussed in more detail later in this manual as well as how the i-limb digits can assist you in completing your daily activities, work tasks, and even some hobbies.
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1.2 Know Your Prosthesis
Your i-limb digits device is a mechanical device to assist with everyday tasks. Although the device may look similar to a natural hand, there are some things that a normal hand can do that are not possible with the i-limb digits device.
To get the most out of the device do not use the i-limb digits device where you would not use a natural hand. The i-limb digits device will limit sensation and so you may not be aware if the hand is being stressed by excessive weight, temperature or moisture, or has been struck by an object that would cause pain in a natural hand. A natural hand and forearm absorb shock, the i-limb digits device is less able to do this. The i-limb digits device will not dampen vibration as much as the soft tissues of a natural hand.
1.3 Wristband
The i-limb digits Wristband has a circumference range of 155mm (6”) to 270mm (10.5”).
The i-limb digits Wristband contains the PCB and two removable 3.7V batteries. It is connected to the main socket by a exible sheath which protects the cabling.
The i-limb digits device will be damaged if the joints are moved in a way in which they were not designed. Do not apply forces to the side of the digits, or move the joints in directions which they are not intended to move.
When carrying a bag or other object protect the hand by resting the handle or strap toward the center of the hand and away from the tips of the digits.
For further information contact your prosthetist.
Your device should be treated like any electrical device, it is important to avoid contact with water or moisture. Wipe your prosthesis dry quickly if there is any contact (review Warnings and Precautions for a comprehensive overview).
76mm
(3”)
95mm (3.75”)
45mm (1.75”)
58mm (2.3”)
Maximum
Minimum
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2.0 Socket Interface
2.1 Socket Interface and Electrodes
Your i-limb digits device has been designed with a socket interface which has been specially created by your prosthetist team. The socket interface should t comfortably and directly to your residual hand. Some minor redness on your residual hand may be normal when you rst remove the device. However if this redness does not go away within 20 minutes or if you have any skin breakdown from your device, contact your prosthetist directly.
As part of the tting process, your prosthetist selected the best
2.2 Battery
i-limb digits is powered by 800mAh, 3.7 Volt batteries which
have been specically designed to meet the power requirements of i-limb digits devices. Four batteries are provided, two for the Wristband and two spares.
Two 3.7v batteries will be needed with the Wristband (the Wristand will not work with only one battery).
method for you to provide control of your device. This tells the processor (the brains of the hand) whether you want the hand to open or close. One option is an electrode. Electrodes pick up on the electrical activity that your body gives off when you contract a muscle. Another option is called a Force Sensing Resistor (FSR). These allow you to put pressure against a pad inside your device using movement from your residual hand. While gaining good control may take time and practice, your method of input should not cause pain. Talk with your prosthetist if you do not understand how your input control is working or if it is causing discomfort.
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The Wristband is switched on and off via the grey button on the central panel. The light sequence is as follows:
On : Red light appears for 8 seconds Off : Red light brief ashes Low power: Green light ashes continually when the charge
level falls below 5%
Batteries are tted into the Wristband battery housing and secured by the holding catch at the wrist side of the Wristband. Release the holding catch to remove the battery.
The batteries provided are designed to work specically
with the Touch Bionics i-limb digits Wristband and are
not to be used with any other device.
Only Touch Bionics batteries are approved for use
with i-limb digits, use of alternative batteries will
invalidate the warranty.
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2.3 Battery Charging
Batteries for i-limb digits should only be charged using the Touch Bionics powerpack and battery charger supplied (UK, European and US style plugs are available). Place the batteries in the charger as illustrated. Insert the charger lead from the battery powerpack into the charge port. Insert the charger into the power outlet.
Charging time from full discharge is approximately 2 hours.
A continual blue light indicates that the battery is charging. When the battery is fully charged the light will go out.
If a continual red light appears for more than 10 minutes then the battery should be replaced.
Only use the plug to disconnect the charger, never
pull the cable to remove the lead.
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As an alternative to charging directly from domestic power, a car charger (PL069380A) is also available.
2.4 Storage and Maintenance
Always turn off the hand when not in use.
Aim to charge the battery each day after use.
Replace the battery every 12 months.
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3.0 biosim
3.1 biosim Overview
The i-limb digits device contains a Bluetooth® receiver enabling it to work with software package known as biosim. Your prosthetist will also have a version of biosim to make changes to how your prosthesis functions. Using biosim it is possible to make changes to the functionality of the i-limb digits device. It will be important for you to understand what these changes mean to your device before changing any settings. Your biosim software provides access to training and games, along with the option to make changes to settings.
The biosim software, working through the Bluetooth® wireless connection, provides access to a range of control options, training features, real time display of impulses, battery status and a Hand Health Check
To use the biosim software with the i-limb digits device you
3.2 biosim Connecting
biosim can be downloaded and access rights set up via
http://www.touchbionics.com/Biosimdownload. Load biosim by clicking on the biosim icon which should be clearly visible on the screen. The biosim Handshake dongle must also be inserted into a USB port to allow the Bluetooth® signal to be received by the i-limb digits prosthesis. The Handshake Bluetooth® receiver will pick up signals within a 10 meter range.
will need either an iPod Touch supplied by Touch Bionics and preloaded with the biosim App, or a PC loaded with the biosim software and used with the biosim Bluetooth® receiver (the system requires either Window XP, Windows Vista or Windows 7; Microsoft.NET framework v3.5; USB port for Bluetooth® connector and administrative rights to install the software and connector). Users of biosim via an iPod touch are directed to iPod Touch with biosim App: Quick Start Guide, provided with your iPod touch (also downloadable from www.touchbionics. com).
Occasionally updates to the biosim software will be provided. An automated notication will advise you when this is needed. Follow the steps as advised in the notication.
N.B. As all i-limb digits device are individually, custom designed products, accurate illustrations of your device is not possible. All illustrations show a full hand and are for guidance purposes only.
The opening welcome screen will load and the rst numerical icon “insert handshake” request will ash. On insertion of the Bluetooth receiver (biosim dongle) the icon will be constantly lit, the “handshake installed and ready” box will then self-tick and the second icon “Turn device off, then back on” will begin to ash. At this point the i-limb digits device should be turned off and then on. The third icon “Connecting to device” will be constantly lit. The tab marked “connect” must now be selected for the connection to be made, this may take up to 24 seconds.
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If there is more than one device (either i-limb digits, i-limb ultra or virtu limb) within range of the Bluetooth® receiver
then a box will appear listing all devices by serial number. In the illustration only one device is listed. The correct i-limb digits device can then be selected from the list. For devices using the Wristband, the serial number is located in the battery housing on the main body of the Wristband, as illustrated. For devices using the full forearm socket, your prosthetist will be able to let you know where to nd the serial number.
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3.3 Navigating biosim
The You’re now connected home screen will now be displayed, with seven options as illustrated. This is the homepage and can be accessed at any time from subsequent pages.
Features allows the set-up of the i-limb digits and is where triggers are linked with with grip patterns and gestures.
Training provides access to the training suite and a selection of games to improve overall control.
Hand health check icon provides a quick and easy diagnostic check of the hand.
Exit icon draws the session to a close, exiting the program.
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3.3.1 Features
Click on the features icon to enter the features suite. The feature page provides access to all available features and associated changes. Features are the actual movements of the hand and triggers are the muscle action used to create the movements.
The grip patterns illustrated are:
First row – 4 precision pinch options
Second row – 4 tripod grip options
Third row – 2 thumb park options, lateral grip and index
point options
Fourth row – custom gesture and custom grip options
Features Catalogue
Precision Pinch Grip Options
Standard Precision Pinch Opened
middle, ring and little nger remain fully opened and switch off. Index nger and thumb provide grip.
Thumb Precision Pinch Opened
middle, ring and little nger remain fully opened and switch off. Thumb automatically moves to a partially closed position. Index nger will move to provide grip against a xed thumb.
Tripod Grip Options
Standard 3 Jaw Chuck (Tripod) Opened
ring and little nger remain fully opened and switch off. Thumb, index and middle ngers move to provide grip.
Standard Precision Pinch Closed
middle, ring and little nger automatically close and switch off. Index nger and thumb provide grip.
Thumb Precision Pinch Closed
middle, ring and little nger automatically close and switch off. Thumb automatically moves to a partially closed position. Index nger will move to provide grip against a xed thumb.
Standard 3 Jaw Chuck (Tripod) Closed
ring and little nger move to terminal close. Thumb, index and middle ngers move to provide grip.
Thumb 3 Jaw Chuck (Tripod) Opened
ring and little nger remain fully opened and switch off. Thumb automatically moves to a partially closed position. Index and middle ngers move to provide grip against a xed thumb.
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Thumb 3 Jaw Chuck (Tripod) Closed
ring and little nger move to terminal close. Thumb automatically moves to a partially closed position. Index and middle ngers move to provide grip against a xed thumb.
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Additional Grip and Gesture Options
Thumb Park Continuous
all four ngers remain open and switch off, only the thumb will move.
Lateral Grip
all four ngers fully close and switch off. Only thumb will move.
Customer Gesture
all ngers automatically move to a fully opened or fully closed position, as preset by the user.
Additional Functioning
Thumb Park Quick
all four ngers remain open and switch off, for 1.5 seconds the thumb will close and then automatically return to an open position.
Index Point
thumb, little, ring and middle ngers close and switch off. Only the index nger will move.
Custom Grip
all ngers automatically move to a user dened position.
Toward the bottom right of the screen the additional Global Options box can be used to give access to Vari-grip / pulsating.
1
Vari-grip / pulsating: this mode provides additional grip
force with subsequent activation of the closed signal. The default setting for activation is 500ms (0.5 seconds) which can be customized between 250 (0.25 seconds) to 3,000ms (3 seconds).
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Triggers
Four potential triggers are available to activate features: Hold open, Co-contraction, Double impulse and Triple impulse.
1
Hold open (a prolonged open signal)
2
Co-contraction (both open and closed signals activated simultaneously) may have already been customized by your
prosthetist to be suited to your own unique signals.
3
Double impulse (two rapid open signals, separated by relaxation below the threshold). Your prosthetist will have pre-set this
at the time of tting.To activate a double impulse the device needs to be fully opened prior to attempting activation.
4
Triple impulse (three rapid open signals, separated by relaxation below the threshold). Your prosthetist will have pre-set this
at the time of tting.To activate a triple impulse the device needs to be fully opened prior to attempting activation.
Any of the above four potential triggers can be linked with any of the above features. Some users are able to perform activities of daily life (ADL’s) without the use of any triggers. In many cases users initially set one or two triggers while familiarity and control is gained.
Linking Triggers with Features
In order to link a trigger with a feature simply click on to the desired feature, the feature will now be highlighted. Select and click the desired trigger which has been selected to link with the highlighted feature. Both feature and trigger should now be highlighted and the descriptive label will now appear under the feature icon. The illustration indicates the Index Point Feature linked to the Hold Open Trigger.
By clicking on any of the features on the features page the available triggers and example sections will also appear. In order to preview a feature simply highlight the feature and click on example to the right of the screen. The section will then enlarge and provide a demonstration of the feature. The hand image can be rotated to improve visualization by holding the left mouse key and moving the curser in the direction of the intended rotation.
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3.3.2 Training
The training suite contains a variety of short training exercises aimed at developing control of the i-limb digits device. The opening screen highlights the series of exercises which can be selected individually and in any order. Both open and closed signals can be
practiced by selecting the appropriate box to the right. Click on “Start” to start the exercise and “Done” when the exercise is complete. An indication of difculty is provided by the 5 point scale on each module.
Strength Only focuses on generating a smooth strong muscle signal without concern for the opposing muscle signal. This exercise helps to strengthen the muscles.
Speed Only focuses on generating quick, strong muscle signals. Do not be concerned about the opposing muscle in this exercise.
Strength and Separation focuses on generating a smooth, strong muscle signal while isolating the opposing muscle. This exercise helps with separation of signals.
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Co-contraction focuses on generating quick, strong simultaneous contractions with both muscles. Do not be concerned with relaxing after the contraction.
Hold Open focuses on generating a strong open muscle signal and maintaining it at a high level for several seconds. Mastering this exercise will enable use of the hold open trigger.
Speed and Separation focuses on generating quick, strong muscle signals while isolating the opposing muscle. This exercise lays the foundation for impulse control.
3.3.3 Hand Health Check
Hand Health Check screen provides a quick and easy check of the hand. Click on the “Run Hand Health Check” icon and the health check will begin. There must be an internet connection to run the Hand Health Check.
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The i-limb digits device will then go through a series of movements as each digit is checked, the process will run for approximately 8 seconds and provide basic feedback on each step.
3.3.4 Exit
Use the Exit icon to fully exit biosim.
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4.0 i-limb digits Coverings
4.1 Cover Options
Silicone digit covers will be provided for the i-limb digits device. Digit covers will be ready to t and designed to cover each digit.
Touch Bionics’ approved digit covers must be used with each digit of the device. The warranty will become void if the device is used without an approved cover.
General Precautions
• The i-limb digits device must be used with approved Touch
Bionics’ digits covers.
• Never put more than one cover on each digit of the i-limb
digits device.
• Always use the digits cover designed for the i-limb digits
device.
• Ensure covers are tted properly.
i-limb digits covers do not provide full protection from moisture, oil, dust and dirt ingress. Caution should be observed.
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5.0 Support Information
5.1 Troubleshooting
Problem
Prosthesis does not
operate
Prosthesis stops midway through an action
Prosthesis is difcult to
operate
Battery charge does not last a full day
Digits open when a closed signal is actioned
Battery is not working
Actio
n
Ensure the prosthesis is switched on
Ensure the battery is connected
Ensure the battery is charged
Check the battery cable is not damaged
Check that the i-limb digits device is connected correctly
Ensure the battery has good charge
Fully charge the battery, this may take up to 2 hours
Check the battery connection
Ensure that you are not holding a sustained signal to the device
Replace the battery
Contact your prosthetist
Check the battery is connected
Ensure the battery charger is working correctly
Check the battery is charged
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5.2 Warnings and Precautions
Batteriesi-limb digits device
Do not use without an approved cover
Do not use under water
Do not use to operate heavy / industrial machinery
Do not use with machinery with moving parts that may
cause personal injury or damage
Users must comply with local regulations on the operation
of automobiles, aircraft, sailing vessels of any kind and
any other motorized vehicle or device
Do not use for extreme activities that may cause injury to
a natural hand
Do not expose to excessive moisture, liquid, dust,
vibration or shock
Do not expose to high temperatures
Do not expose to naked ames
Do not use or expose to explosive atmospheres
Do not disassemble componentry or modify in any way
Maintenance, repairs and upgrades may only be
performed by qualied Touch Bionics technicians and
technical partners
Do not bend or exert excessive pressure on the battery
Do not pierce the battery
Do not disassemble
Do not expose to high temperatures
Do not incinerate batteries
Do not alter battery terminal wires
Do not short circuit the battery
Do not store batteries inside a vehicle
Dispose of batteries in accordance with US, European or local regulations
Only use the appropriate Touch Bionics charger to charge Touch Bionics batteries
If the battery has visibly ballooned or swelled:
• discontinue the charging process immediately
• disconnect the battery
• remove to a safe area
• leave and observe for 15 minutes
• replace the battery
• do not re-use
• dispose of any leaking batteries in an appropriate
manner
Do not use with a damaged cover
Damaged covers must be replaced or repaired by a
qualied Touch Bionics technician or technical partner
Only approved Touch Bionics accessories and tooling
may be used with the i-limb digits device
Failure to comply with the above guidelines will invalidate
the warranty.
A list of frequently asked questions can be found on the Touch Bionics website.
If you experience technical
problems with the i-limb digits
North American Customers (Canada, Mexico & US)
Tel:+1 855 MYiLIMB (694 5462)
device call your prosthetist or Touch Bionics as follows:
UK & Non-North American Customers
Tel: +44 1506 438 556
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Driving of Motor Vehicles
The i-limb device has the functional capability to assist a patient with driving a motor vehicle however due to factors including the differences in world-wide driving regulations and the variations in the level of ability between patients Touch Bionics is unable to provide denitive advice in respect of a patient with an i-limb device driving a motor vehicle.
Touch Bionics is aware that patients have used the i-limb to drive a motor vehicle and our recommendations prior to a patient doing so would include the following:-
• contacting the driving authority in your home location to obtain and understand the local regulations;
• working with the appropriate authorities to have your car modied to meet the local regulations for your respective disabilities as
required;
• re-taking any mandatory driving test using your i-limb device to demonstrate your ability to operate a motor vehicle safely if
required by local regulations;
• contacting your insurance provider and advise them that you will be using the i-limb device to drive a motor vehicle;
• ensuring that the device has a fully charged battery. Please note that the i-limb device will emit a low battery signal which will
alert you if the battery requires to be charged;
• switching off the i-limb device. This is due to the possibility of involuntary muscle signals being generated; and
• moving the thumb into the lateral position to allow the i-limb to be removed from the steering wheel without opening the hand.
It is entirely the patient’s responsibility to seek conrmation that they are physically and legally able to drive using the device and to the fullest extent permitted by law Touch Bionics shall under no circumstances whatsoever be liable to the patient or any other party as a result of or in connection with a patient with an i-limb device driving a motor vehicle.
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6.0 User Information
6.1 User Details
Provision of the following basic information will enable easy identication if the prosthesis is returned to Touch Bionics customer service. Please forward details to Touch Bionics as per the contact information on the back page of the manual.
User Name:
Fitting Date:
Hand Purchase Date:
Hand Serial Number:
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7.0 Appendix
7.1 Technical Information
Activity i-limb digits
Push up from wheelchair: full hand 80Kg/176lbs
Push up with one digit 20Kg/44lbs
Carry heavy bag full hand 100Kg/220lbs
Carry heavy bag one digit 25Kg/55lbs
Carry heavy bag on thumb 25Kg/55lbs
7.2 Component Compatibility
1. General Safety
1.1 The i-limb digits device is an electrical device, which under certain circumstances could present an electrical shock hazard
to the user. Please read the accompanying user manual thoroughly and follow directions stated in the manual to assure maximum safety during charging and operation.
1.2 EN 60601-1:2006
1.2.1 Protection against electrical shock – Class II
1.2.2 Degree of protection against electrical shock – Type BF provides additional protection against electric shock
1.2.3 Degree of protection against ingress of water (IEC 60529:2001) – IP40
1.2.4 Not suitable for use in the presence of ammable anesthetic mixture with air or with oxygen or nitrous oxide
1.3 EMI/EMC
1.3.1 Compliance against standard EN 60601-1-2:2007
1.4 Radio Spectrum Matters (ERM)/Bluetooth
1.4.1 Compliance against standard EN 301 489-1 V1.8.1
1.5 EN 301 489-3 Clause 7.1
1.5.1 EN55022: 2006
1.6 Radiation emissions, Enclosure
1.6.1 EN 301-489-1 Clause 8.2 - Pass (30MHz to 6,000MHz)
1.7 Zones of Use
1.7.1 Not recommended in zones 0, 1, 20 and 21
N.B. See www.touchbionics.com for further information on EMC testing carried out on products within this manual.
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Refer to operating instructions
Class II equipment – provides double Isolation to protect against electric sho
ck
Degree of protection – IP40
IP40
Protection against penetration by solid particles with diameters larger than 1 mm. No special protection against penetration by water
Batch/Lot/ID Number
For i-limb digits devices:
Each device has a guaranteed unique id number example: 0001:2012
The unique serial number for i-limb digits devices is a D with a 4 digit alpha / numeric number. The year of manufacture of the device is then added.
WEEE Compliance
1. Customer Service/Contact Information:
Touch Bionics, Unit 3 Ashwood Court, Oakbank Park Way, Livingston EH53 0TH, UK
Tel: Customer Service: +44 (0) 1506 445 415 Tel: General Enquiries: +44 (0) 1506 438 556
www.touchbionics.com
Part number: MA01063: Issue No. 1, December 2012
Catalogue numb
er
Manufacturer
Keep Dry
Touch Bionics, 35 Hampden Road Manseld MA 02048, USA
Tel: +1 855 MY iLIMB (694 5462)
www.touchbionics.com
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7.3 Warranty
Limited Warranty for i-limb digits
Touch Bionics warrants that the i-limb digits components will conform to its specications and be free of defects in material and/ or workmanship for a period of thirty-six (36) months from the date of Touch Bionics invoice for i-limb digits components. This Limited Warranty applies only to i-limb digits components provided by Touch Bionics or an accredited Touch Bionics provider. This Limited Warranty applies to all components including but not limited to xtures, motors, bearings, and electronics for the same thirty-six (36) month period. This Limited Warranty is governed by UK law and is not transferrable.
Warranty:
Touch Bionics reserves the right to credit, repair or replace “in-warranty” i-limb digits components as its option. If required, replacements will be new products. The wearer shall report any defect claim to Touch Bionics directly or to the facility that provided
i-limb digits components immediately upon discovering the defect, and, in any event, within the warranty period. The defective i-limb digits component must be returned to Touch Bionics or any other Touch Bionics provider. To nd the nearest location,
please search online at www.touchbionics.com or call +1-855-MY-iLIMB (US & Canada) or +44 (0) 1506 438 556 (International). Wristband, digits, electrodes and wiring loom components must be returned as originally shipped.
The warranty is void if the i-limb digits component is subjected to abuse, neglect, alteration, modication, improper repair and/ or maintenance performed by anyone other than Touch Bionics or an accredited Touch Bionics provider. Damage as the result of normal wear and tear including the result of fatigue is not covered during the warranty period. Damage resulting from installation of parts and accessories not compatible with i-limb digits by anyone other than Touch Bionics or an accredited Touch Bionics facility is not covered, including use of non-Touch Bionics batteries.
This is the exclusive remedy under this warranty, any and all other remedies that may otherwise be applicable are excluded, including, but not limited to, incidental or consequential damages or punitive damages to the maximum extent permitted by law. This is the only warranty made by Touch Bionics on i-limb digits components, and there are no warranties which extend beyond the description herein. Any warranties that may otherwise be implied by law including, but not limited to, any implied warranty of merchantability or tness for a particular purpose are excluded.
This Limited Warranty gives the consumer specic legal rights. The consumer may also have other legal rights which vary from country to country, from state to state in the U.S., from province to province in Canada and from state to state in Mexico. Some countries and states may not allow the exclusion or limitation of incidental or consequential damages or warranties, so the above limitations or exclusions may not apply to you. If it is determined by a court of competent jurisdiction that a certain provision of this limited warranty does not apply, such determination shall not affect any other provision of this limited warranty and all other provisions shall remain in effect.
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North American Customers
(Canada, Mexico & US)
Touch Bionics
35 Hampden Road
Manseld MA 02048
USA
Tel: +1 855 MY iLIMB (694 5462)
International Customers
Touch Bionics
Unit 3, Ashwood Court
Oakbank Park Way
Livingston EH53 0TH
Scotland
Tel: +44 1506 438 556
For address details and further information
please visit www.touchbionics.com
Third party products and brand names
may be trademarks or registered
trademarks of their respective owners
© Copyright 2012 Touch Bionics Inc. and Touch EMAS Ltd. All rights reser ved.
Issue No. 1, December 2012 Part number: MA0163
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