touch bionics i-limb select User Manual

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i-limbTM select Manual
Part number: MA 01155: Issue No. 4, January 2015
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This is an i-limb ultra that has been refurbished. This document provides instruction for prosthetists in the tting and servicing of the i-limb select and should be read in full prior to tting. It is highly recommended that the use of this manual is made in conjunction with instruction from a clinician experienced in upper limb and myo-electric prostheses.
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Table of Contents
1. i-limb select 1.1 Product Description
1.2 Intended Use
1.3 Prosthesis Overview
1.4 Features catalogue
2. Socket 2.1 Control Sites
2.2 Socket Fabrication
2.3 Charge Port Placement Assembly
2.4 Battery Options
2.5 Battery Conguration
2.6 Battery Installation
2.7 i-limb Power Pack
2.8 Battery Charging
3. Wrist 3.1 Wrist Connection Options
3.2 Quick Wrist Disconnect (QWD)
3.3 Wrist Disarticulation
4. Adjustments 4.1 Digit Conguration
4.2 Digit Installation
4.3 Thumb Installation
5. Covers 5.1 Cover Options
6. biosim app clinician version 6.1 biosim app Overview
6.2 Getting Started
7. my i-limb patient version 7.1 my i-limb Overview
7.2 Getting Started
8. Support Information 8.1 General Safety, Warnings and Precautions
8.2 Troubleshooting
9. Appendix 9.1 Technical Information
9.2 i-limb select Information
9.3 Component Compatibility
9.3.1 EMC and Electrical Information
9.4 Warranty
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1.0 i-limb select
1.1 Product Description
The i-limb select is an externally powered, multi-articulating prosthetic hand which oers a range of features beyond the functions of the traditional prosthetic hand.
Individually motorized digits and the unique biosim and my i-limb app used to control the i-limb select result in one of the most versatile prosthetic hand currently available to the global market.
Users can choose from a wide selection of automated grips and gestures to help complete daily tasks. Grips and gestures can then be customized further for precise control.
The i-limb select oers compliant grip through individually powered digits with stall out ability. A manually rotating thumb in conjunction with a pulsing, enhanced grip (vari-grip), and the wide range of automated grip patterns lead to broad functionality.
1.2 Intended Use
The i-limb select is intended to be used by patients with upper limb loss or deciency
1.3 Prosthesis Overview
The i-limb select is available in small or medium sizes. The hand serial number is positioned proximal to the base of the thumb on the connection plate. The serial number will start with a “Q” and be followed by four numbers.
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Motorized Digit
Knuckle
Palmar Fairing
Manual Thumb Rotator
On / O Switch
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1.4 Features Catalogue
The i-limb select has 12 dierent grip options available. These grips can be accessed through biosim and the my i-limb app. This following Features Catalogue will review the various available grips and provide a functional description of each.
Precision Pinch Grip Options
Precision pinch grip options are best for picking up small items between and the thumb and index nger. There are 4 options available depending on how you want the other digits to perform while doing the pinch. The most popular is Thumb Precision Pinch Closed.
Standard Precision Pinch Opened
middle, ring and little nger remain fully opened and switch o. Index nger and thumb provide grip.
Thumb Precision Pinch Opened
middle, ring and little nger remain fully opened and switch o. Thumb automatically moves to a partially closed position. Index nger will move to provide grip against a xed thumb.
Standard Precision Pinch Closed
middle, ring and little nger automatically close and switch o. Index nger and thumb provide grip.
Thumb Precision Pinch Closed
middle, ring and little nger automatically close and switch o. Thumb automatically moves to a partially closed position. Index nger will move to provide grip against a xed thumb.
Tripod Grip Options
Tripod Grip Options provide a grip where the thumb is meeting up with the index and middle digits. Typically the thumb is rotated between the index and middle to provide more stability when gripping slightly larger objects than those with the precision pinch grips. As a result of having a motor in each digit and the hand conforming to the shape of the object being held, the hand will automatically form a tripod grip when the object is small enough to only be gripped between the thumb, index, and middle digits. The advantage of using the tripod grip options is if you want the ring and small digits to stay either fully open or fully closed when gripping.
Standard 3 Jaw Chuck (Tripod) Opened
ring and little nger remain fully opened and switch o. Thumb, index and middle ngers move to provide grip.
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 o. 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
With these additional grip patterns and gestures, consider how often you perform dierent tasks and if having a program for that activity would make it easier/faster for you to perform. Since each digit has its own motor, you can put pressure against any digit to stop it from moving (called stalling the digit). Many of these additional grips can be performed by stalling one or more digits. If it is a task that is not performed often (maybe using index point to press the “Shift” key on a keyboard) then you may prefer to just stall the digit. However, if you frequently perform the task or want to go into the position without needing to put the hand against the table or your other hand, then programming the grip may be the better option.
Thumb Park Continuous
all four ngers remain open and switch o, only the thumb will move.
Lateral Grip
all four ngers fully close and switch o. Only thumb will move.
Thumb Park Quick
all four ngers remain open and switch o, 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 o. Only the index nger will move.
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2.0 Socket
2.1 Control Sites
The i-limb select is controlled by compact electrodes (g. 1).
For information regarding the tting of the Touch Bionics electrode, review the manual provided with the electrode.
Electrode Site Selection
The use of virtu-limb, the Touch Bionics’ myo-testing system, is recommended to determine the optimal placement of electrodes (g. 2). virtu-limb is not included with the i-limb select. Contact Touch Bionics for information about ordering virtu-limb.
Do not rely on previous myo-electrical testing.
Consult Touch Bionics training materials for information on myo­testing.
Figure 1. Compact Electrode
Use anatomical sites where the electrode will maintain constant, even contact with the skin. Avoid placing electrodes near socket interface trim lines, bony areas, skin grafts or fatty tissue.
Figure 2. virtu-limb
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Prosthetist must ensure that the plastic screw provided
is utilized and properly tightened on the coaxial plug
(g.3) where the battery and electrodes connect, to
prevent loose connections .
2.2 Socket Fabrication
While fabricating the socket for the i-limb select, special considerations will need to be given to:
1. Battery placement, size and conguration
2. Electrode position
3. Charge port placement
4. Socket length and the overall length of the prosthesis in comparison to the opposite side.
Clinicians should have prior experience with building externally powered prosthetic sockets before tting the i-limb select.
Touch Bionics’ batteries, charger port and switch block components should always be used with the i-limb select.
Figure 3. Coaxial Plug
We recommend that a rubber grommet or plastic cap
is placed over any socket holes to protect the integrity
of the electrode.
During socket fabrication, appropriate measures must
be taken to prevent sweat entering into the battery
connector within the lamination ring, which may result
in a short circuit and compromise use of the device.
Conventional sweat prevention methods include the
use of drain holes and suction sealing electrodes.
Alternatively, silicone may be used to seal the interface
area between the battery connector and co-axial plug
into the prosthetic socket.
During socket maintenance, ensure a check of the
battery connector/co-axial plug interface is carried out.
Socket Material
The use of Carbon ber is not recommended due to
electrical conductivity.
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Coupling Piece Assembly for QWD Wrist
Insert the castelation ring (coupling piece) into lamination ring and turn until seated. Insert retaining ring around outside edge of coupling piece and use QWD release tool to seat the retain­ing ring. The QWD release tool is available to order from Touch Bionics.
Battery Placement
Use Velcro® to position the batteries on the pre-prepared at surfaces to prevent distortion.
Battery Placement for a Long Residual Limb
Consideration of battery placement is particularly important in longer sockets. The shape of the inner socket must also be considered.
If the residual limb is long or bulbous, the position of the battery dummies and charge port are best placed midway up the arm along the inner socket ensuring they will not impact the ability to don/do the prosthesis and that the postion will not result in pressure from the residual limb that could distort the battery.
Placement of batteries should allow for removal of the inner socket.
If the socket has a bulbous distal end, do not position batteries or charger port around the narrow region of the prosthesis.
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2.3 Charge Port Placement Assembly
It is important to provide sucient space for the charge port between the inner and outer sockets. The charge port should be positioned so that it is unaected by forces running through the socket to prevent damage.
Create a drill hole of 8mm through the inner surface of the prosthetic frame. Ensure a at surface has been created to accommodate the charge port mounting frame (if installing a switch block as an alternative to the charger port, create a drill hole to cater for the panel mount).
Smooth the edges of the drill hole and insert the threaded charge port. A minimum thread height of 3.2mm above the socket surface is required for full engagement of washers and locking nut.
Position the M8 Lock Washer and the M8 Flat Washer before hand tightening the the locking nut.
Use a 3/8” wrench to tighten the locking nut. Do not overtighten.
Do not use pliers on the charge port.
Position the M8 Lock Washer and M8 Flat Washer in place over the threaded shaft of the charger port. Engage the M8 locking nut with the threaded shaft and tighten rmly by hand.
The use of both the Lock Washer and Flat Washer is vital to ensure the charge port is not damaged by over tightening.
Do not overtighten!
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2.4 Battery Options
The i-limb select comes with a 1,300mAh battery. This battery has been specically designed to meet the power requirements of the hand.
i-limb 1,300 mAh
Battery
Capacity 1,300 mAh
Length 70mm (2.76”)
2.5 Battery Conguration
The image opposite shows the 1,300mAh battery option .
Only Touch Bionics batteries are approved for use with the i-limb select. Use of alternative batteries will invalidate the warranty.
2.6 Battery Installation
The battery is designed to be mounted inside the socket interface. Ensure there is adequate space between the residual limb and the wrist (or elbow) to accommodate the battery, char­ger port and any other componentry. Use the battery dummy to fabricate a relief for the battery in the socket interface.
Battery Dimensions
Dummy Battery Dimensions
Application Moderate Use
Width 35mm (1.39”)
Height 6mm (0.24”)
Length 69mm (2.77”)
Width 35mm (1.39”)
Height
10mm (0.39”) Single cell 16mm (0.63”) Dual cell
When planning battery location and dummy placement for fabrication, keep in mind a maximum distance of 135mm is possible between cells due to wire length.
Installing i-limb Power Pack
Utilize battery dummies on top and bottom of socket to create necessary space to accommodate battery housing.
Use standard fabrication processes and technique to create an opening in the socket to accommodate battery housing.
When using a switch block, it is recommended that you use the provided Switch Template (g. 4) to guide drill holes.
Ensure there is no contact between the battery housing and inner socket
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Figure 4
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Do not apply excessive force to the charger
socket interface during assembly.
A minimum of 2mm of free space surrounding the charger port should be provided.
A at surface is needed to secure the charger port to the socket interface frame. This may require additional shaping of the frame section above the dummy battery. Use the Velcro
®
strip supplied to
attach the battery to the inside of the socket interface.
Wiring Schematic for 1300mAh Low Prole
Battery with D.C. Socket
2.5mm D.C. Socket
Co-axial Bush/Rotator
If the area between the residual limb and the lamination ring is insucient to house the battery, you will need to position the battery between the socket interface and the frame. This will be necessary when:
• the residual limb is longer than 60% of the humeral or forearm
section of the prosthesis
• the battery is too large for the space available in the socket
interface frame
Cutting or modifying the battery wires in any way will invalidate the warranty.
Low Prole Battery Cells Placed Side by Side
Do not bend or shape the battery in any way.
Ensure the battery is not subject to continued pressure once tted.
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2.7 i-limb Power Pack
i-limb Power Pack (ordered separately) are for users who want the ability to easily replace batteries.
Battery housing is fabricated on top and bottom of socket, allowing for easy access.
Top of socket
Bottom of socket
i-limb Power Pack kit
i-limb Power Pack includes the following items:
• 1 dual battery housing unit (g. 5).
• 4 Removable 800 mAh batteries (g. 6) with low battery LED indicator.
Battery LED will glow RED when batteries are below 10% charge.
• 2 Battery housing dummies (g. 7).
• Dual battery charger base unit (g. 8).
• Wall charging unit (g. 9).
• Switch Assembly. Switch Block is typically used in conjunction with
a wrist rotator or for patients who would like a power o control on the socket) (g. 10).
• Switch template Switch Assembly (if Switch Assembly is ordered)
(g. 11). This template is to be applied to the desired position on the socket to help guide drill holes.
• 2 Battery Pull cords (g. 12). Benecial for bi-lateral patients, the
battery pull cord provides a simple solution for removing the battery in your socket.
Figure. 5 Figure. 6
Figure. 7
Figure. 9 Figure. 10
Figure. 8
• Country specic charger plugs.
• Car charger.
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Figure. 11
Figure. 12
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2.8 Battery Charging
Please review the below Instructions for proper internal battery charging.
Only use supplied Touch Bionics charger to charge battery. Depending on your location, you will receive one of the below chargers (g. 14, or g. 15)
The patient will need to remove the socket from their arm and turn the i-limb device o. The on/o switch is pictured in g 13. i-limb device is o when switch is in left position.
Insert the charger (g. 14 or g. 15) into the power outlet. The charger will need to be inserted into the power outlet prior to connecting to the charge port. To charge, insert the charger lead connector into the charge port. A “click” should be heard on connection. If the green light is on when you rst plug in the device, ensure the switch block is o.
Charging time is approximately:
1,300 mAh battery- 90 minutes
2,000 mAh battery- 180 minutes
The light display for g. 14 is:
• Solid Red – charging
• Solid Green – fully charged or idle
• Continuous ashing red – fault condition
• Rapid ashing amber – Threshold state between charging
and fully charged ( should only last for 1-2 seconds)
• Continuous ashing red or green – Connection Error.
Remove charger lead connector from the charge port. Ensure charger is plugged in and switched on at the mains. Re-insert the charger lead connector into the charge port.
The light display for g. 15 is:
• Solid Amber – on standby
• Slow ashing amber – pre-charge mode
• Rapid ashing amber – Error
• Slow ashing green – maintenance charge
• Rapid ashing green – rapid charge
• Solid green – fully charged
To remove the charger lead connector from the i-limb select, grip the connector and pull directly away from the port. Consult Warnings and Precautions for additional information.
Figure. 13
On/O Switch
Figure 14
Figure 15
If the patient intends to travel outside of their home country, they will need to ensure they have a Touch Bionics charger that will work in the country to which they are traveling. Additional chargers are available from Touch Bionics.
To ensure the i-limb select is continually functional, charge at the end of each day.
Replace the battery annually for optimal performance.
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Do not pull cable to remove the lead.
Switch the hand OFF to preserve battery power when not in use.
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i-limb Power Pack Charger
i-limb Power Pack batteries for i-limb select should only be charged using the Touch Bionics battery charger (g. 16) supplied. 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.
Figure. 16
On the base plate of the charger (g. 17) you will see the various light sequences:
• Middle light on: Charger is plugged in
• 2nd and 5th lights blinking Green: Batteries are charging
• 2nd and 5th lights solid Green: Batteries are charged
• 1st and 4th Red lights on: Battery fault, unplug and try
again. If lights continue to illuminate, contact Touch Bionics Customer Support.
Only use the plug to disconnect the charger, never
pull the cable to remove the lead.
Figure. 17
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3.0 Wrist
3.1 Wrist Connection Options
The following wrist connection options are available for the i-limb select:
1
Quick Wrist Disconnect (QWD)
2
Wrist Disarticulation
3.2 Quick Wrist Disconnect (QWD)
The QWD is supplied by Touch Bionics.
Connecting the i-limb select using the QWD
1
Ensure the i-limb select is switched o.
2
Align the QWD connection of the i-limb select with the
connection in the forarm socket.
On/O Switch
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3
Engage the coupling.
Test the connection is fully engaged with a slight rotation.
4
Disconnecting the i-limb select using the QWD
1
Ensure the i-limb select is switched o.
2
Support the i-limb select in the palm of the hand.
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2
Rotate the i-limb select through 360° in either direction until
3
a click is heard
3
4
The i-limb select will now disengage from the socket.
Support the hand and withdraw away from the socket
3.3 Wrist Disarticulation
The wrist disarticulation is fabricated directly into the socket frame and then attached to the i-limb select by the following steps:
1
Disconnect the Palm Fairing from the i-limb select chassis
by unscrewing the screw in the palmar surface using a T10 Screwdriver (available for order).
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2
Remove the Wrist Disarticulation and feed the power cable
through.
3
Align the slots and slide the Wrist Disarticulation plate onto
the WD Lamination Plate at base of the i-limb select ensuring it is rmly engaged.
4
Secure the Wrist Disarticulation plate to the WD Lamination
Plate using a T10 screw and a T10 Screwdriver.
5
Replace the Palm Fairing onto the chassis by hand tightening
the screw in the palmar surface using a T10 Screwdriver. Ensure that the Palm Fairing does not pinch the wiring.
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Fabrication of the Wrist Disarticulation into the socket
must allow for disengagement of the hand from the Wrist Disarticulation plate. Otherwise complete fabrication of the Wrist Disarticulation into the socket in the usual manner.
To disconnect the Wrist Disarticulation from the i-limb select
complete the above steps in reverse:
1
Disconnect the Palm Fairing from the Chassis. Be careful to
not damage wiring when removing the Palm Fairing.
2
Loosen the WD Lamination Plate Screw from the Wrist
Disarticulation plate.
3
Slide the Wrist Disarticulation o the base of the i-limb select.
4
Separate the i-limb select from the Wrist Disarticulation,
drawing the Basket cable through the Wrist Disarticulation.
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4.0 Adjustments
4.1 Digit Conguration
Individual digits for the i-limb select are manufactured as sizes 2, 3, 5 and 6. Sizes 2 and 3 contain a small motor, while sizes 5 and 6 contain a a larger motor. The standard digit conguration of the small and medium sized i-limb select is outlined in the table.
4.2 Digit Installation
The i-limb select is only compatible with Touch Bionics i-limb select digits. To install a digit, ensure that the correct digit size is selected. Remove the digit by the following steps:
1
Ensure the i-limb select is switched o.
2
1
Support the i-limb select in the palm of the hand with the
digits in the fully open position. Insert the T10 Screwdriver in the screw of the Knuckle block (supplied see 4.3).
i-limb select size
Digit Small Medium
Thumb 5 6
Index 5 6
Middle 5 6
Ring 3 5
Little 2 2
3
Loosen the Knuckle block screw while supporting the digit,
remove the digit.
1
4
Select the appropriate sized replacement digit and follow
the steps in reverse order to replace.
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It is recommended that you discard the used screws as the anti­vibration pad on the screw shaft will be deformed during use. Digit screws should be replaced using the new screws provided.
Do not over tighten screws.
If there is resistance while tightening the screw check for cross threading by removing and re­inserting the screw.
4.3 Thumb Installation
The i-limb select is only compatible with Touch Bionics i-limb select thumb digits. When exchanging a thumb, ensure the correct size has been selected.
Instruments required: T10 Screwdriver provided by Touch Bionics.
1
Support the i-limb select in the palm of the hand.
2
Fully rotate the thumb to the side as illustrated.
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3
Disconnect the Palm Fairing using the T10 screwdriver to
loosen the palmar T10 screw.
4
Gently move the Palm Fairing to the ulnar side to allow
access to the exposed T10 screw at the base of the thumb.
5
Using the T10 Screwdriver access the screw from the
medial to lateral direction to loosen.
6
The thumb is now easily removed from the knuckle block.
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7
Position the replacement thumb in the knuckle block and
follow the above steps in reverse order to reconstruct the hand. When replacing the palm fairing, ensure wires are not pinched between the palm fairing and the chassis.
It is recommended that you discard the used screws as the anti­vibration pad on the screw shaft will be deformed during use. Digit screws should be replaced using the new screws provided.
Do not over tighten screws.
If there is resistance while tightening the screw check for cross threading by removing and re-inserting the screw.
Touch Bionics recommends T10 Screwdriver for use with all T10 screws in the i-limb select.
Do not reuse screws
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5.0 Covers
5.1 Cover Options
The cover of the i-limb select is very important.
The i-limb select can be used with both i-limb skin active and i-limb skin natural covers. These covers require regular checks for wear and tear. Covers will need occasional replacement depending on level of use. Contact your distributor to purchase additional covers.
The i-limb skin active cover is designed for the i-limb select and will fully cover the hand. The palm and inner surface of the cover provide some frictional properties for slip resistance when gripping. The back of the glove is smooth to allow the hand to easily move through sleeves of clothing.
Please consult the Coverings Care Guide for donning and dong instructions as well as tips on wear and care. The Coverings Care Guide can be found on our website at www.touchbionics.com/ downloads/document-library.
The i-limb select should not be used without an approved cover that is well maintained.
Do not alter covers
Only use approved Touch Bionics covers. Covers that are not approved will damage i-limb select
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6.0 biosim app clinician version
6.1 biosim app overview
Welcome to the mobile world of Touch Bionics! The biosim mobile application is provided for you to quickly and easily change the features of the i-limb select prosthesis while on the move.
Important points to note:
• The biosim mobile app must be downloaded from the
• Please ensure that you select the biosim app shown by the
• The iPod (sold separately) connects to your i-limb select via
• The biosim mobile App is compatible with the following
• To exit the application at any time, simply press the main
®
Apple
App store
grey and white logo
a Bluetooth connection, which is automatically established when you start the biosim app
devices: iPhone® (4s or newer), iPad® (4th generation or newer), iPad® mini, iPod® (5 or newer).
“Home” button on the front of your mobile device.
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6.2 Getting started
For general instructions on using your iPod Touch (sold separately), read the quick start guide provided by Apple in the packaging of your iPod Touch.
The rst time that you use the device you will need to be connected to the Internet via the iPod’s Wi-Fi connection. You can connect to a Wi-Fi network by tapping on the “settings” icon on the rst screen.
Next go to the App Store via the icon. Tap on it to start the app. To search for the biosim app, type “Touch Bionics” or “biosim” in the search tab and download the app to your iPod.
Note: an Apple ID will be required to down load the app. If you do not have one , please create an account by logging on to the Apple website or using another mobile device.
After installation of biosim
Upon downloading the biosim mobile app, an icon will appear on your iPod screen. Tap on it to start the app.
Activation
The rst time you connect to biosim, you will see the “Sign in” screen. Here you will need to enter the email address and password that you use when you log-in on the Patient Care Pathway on Touch Bionics’ web site. If you need to create an account, you may also do so by selecting “Register” on the screen shown.
Note
Touch Bionics recommends using the latest Apple iOS for best performance. If you are using an older version of iOS, you may receive a one-time notice. Tap “Continue” to acknowledge.
Activation
You will need to activate your account by conrming the email sent to the email account you provided prior to being able to connect. Upon registering, please review the Terms and Conditions. Tap “Accept“ to continue.
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Firmware Updates
Touch Bionics‘ always recommends that you download the latest rmware for your device. If a rmware update is available, you will be prompted with the following screen upon connection to biosim.
Tap "Apply“ to initiate the update. Tapping "Cancel“ will dismiss this screen.
Firmware Updates
Tapping "Apply“ will bring you to the rmware update warning screen. Ensure you read and comply with all warnings. Tap "Continue with update" to proceed.
Note: Ensure that you are able to perform the update without interruption. Loss of power or hand communication could result in your device locking, which will require service by Touch Bionics. Total update time may take up to 10 minutes.
After tapping "Continue with update" you will arrive at a nal conrmation screen. Tap "Yes" to continue.
At the conclusion of the update you will be prompted to turn your device o and back on again to complete the update.
After powering o and on, tap "Reconnect" to continue using the biosim app.
After tapping "Yes" the update will begin. You will see a variety of screens as the update progresses. Update screens may vary depending on device updated.
Connection
After signing in, you will be brought to the connection screen where you will tap your device to connect.
Searching for another device
Tap the search icon to disconnect from the current hand at any time and search for a dierent hand. You will be prompted to conrm.
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Tap No to return to the app
Tap Yes to disconnect.
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Connection
When hand is turned on and ready to connect, the screen will show this display
Tap on the desired device serial number to begin the connection process.
Authorized User Access
In order for you to connect to a patient’s device, they will need to tell you their 4 digit serial number located proximal to the base of the thumb on the connection plate. You will be prompted to enter this after selecting the patient’s device.
Connecting
If the app is unable to connect to the selected hand, the screen at the right will appear.
Turn the hand o and back on, then make sure the hand is functional.
Tap search to try again
Favorites
Here you can assign groups of grip patterns and triggers a single name to make them easily accessible with a single tap.
Accidental disconnection
If the hand should disconnect from the app due to loss of power or proximity with the i-pod/phone the screen at the right will appear:
Tap Reconnect to re-establish the connection
Editing favorites
Tap the edit button at the top right and the screen changes to look like the one at the right
Tap the red symbol to delete the favorite
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Grab the handles and drag to re-order the list
Tap the name of the entry to edit the favorite
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Editing favorites
Tap here to change the name
Tap here to change the icon associated with the favorite.
Tap here to change the features and triggers that will be sent to the hand when this favorite is activated from the favorite list.
Editing favorites
Tap an icon to choose one to associate with the favorite you are editing.
Editing favorites
Tap a feature to change its trigger and options if available
Editing favorites
Once all changes have been made use the top left button to navigate back to the screen at the right.
Editing favorites
Edit the trigger associated with the previously tapped feature.
Tap a trigger to change the association.
Tap the edit features button in the top left to return to the list of features
Save a new favorite
To save a new favorite with the currently active features and triggers, tap the + button.
Tap the Save button to permanently store the changes in the list of favorites.
Favorites are not stored in the hand, only within the app.
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Save a new favorite
Tap the text eld to type in a name for the new favorite
Tap the Icon entry to choose an icon for the new favorite
Save a new favorite
Tap an icon to choose one for the new favorite
Save a new favorite
Tap the save button to add the new favorite to the list of all favorites.
Can also tap the cancel button to abort the creation of the new favorite.
Currently active hand settings
The settings pages present the user with the currently active hand conguration.
Save a new favorite
Switch to the favorites page by tapping on the heart.
Notice the presence of the new favorite created in the last several slides.
Any changes made on the settings pages are sent to the hand and take eect immediately.
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Currently active features and triggers
Tap a feature icon to change its trigger association.
Currently active features and triggers
Tap a trigger to change its association with the selected feature
Tap the disclosure triangle to adjust the settings for a specic trigger
Currently active features and triggers
Set the hold open detect time by tapping the existing value
Currently active features and triggers
Set the co-contract detect time by tapping the existing value
Currently active features and triggers
Use the spinning selection dial to choose a new value and tap the Save button.
Tap cancel to keep the current value.
Currently active features and triggers
Use the spinning selection dial to choose a new value and tap the Save button.
Part number: MA 01155 Issue No. 4, January 2015
Tap cancel to keep the current value.
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Currently active features and triggers
This is an example of the features page after the changes from the previous page.
Notice the highlighted feature with the trigger name under it. This indicates the Hold Open trigger will cause the hand to enter the Thumb precision pinch
Other features
This page can be used to enable or disable the various global features of the hand.
Currently active features and triggers
Tap the current vari-grip delay setting.
Use the spinning selection dial to choose a new value and tap the Save button.
Tap cancel to keep the current value.
Currently active features and triggers
Use the sliders to adjust how far open or closed the ngers should be when natural hand mode activates.
Tap the current natural hand nger position entry.
Currently active features and triggers
Tap the current natural hand delay setting.
Use the spinning selection dial to choose a new value and tap the Save button.
Tap cancel to keep the current value.
Currently active features and triggers
Scroll down the page to reveal entries that will set all the ngers to default values.
Tap Other to keep the current values.
Use the sliders to choose nger positions and tap the Save button.
Tap Other to keep the current values.
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Change control strategy
The highlighted icon indicates the current control strategy.
Tap the desired control strategy to change it.
Real time graph
The real time graph is best viewed in landscape mode by rotating the device horizontally.It will show the user’s input signals. Red for the open signal and blue for the close signal.
Rotate the device to portrait mode or tap the Done button to exit the graph.
Tap the camera button to save a snap shot to the camera roll. Use the swipe gestures to scroll the graph backwards and forwards to review up to 2 minutes of history.
Real time graph
Tapping on the real time graph will let you change the gain and threshold settings.
Adjust the sliders to make changes. Red for the open signal and blue for the close signal.
Tap the Save button to commit the changes or tap cancel to return to the real time graph.
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Multilingual support
Choose which language should be used by the app.
About the App
This screen gives information about the hand and the app.
Choosing system default will make the app use whatever language the rest of the iPhone is using.
Signing out
You will be prompted to conrm the sign out choice as this cannot be undone.
Tap No to return to the app
Tap Yes to sign out.
Tap sign out to disconnect the app from the PCP account you are currently logged into.
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7.0 my i-limb patient version
7.1 my i-limb Overview
Welcome to the mobile world of Touch Bionics! The my i-limb mobile application is provided for you to quickly and easily change the features of the i-limb select prosthesis while on the move.
Important points to note:
• The my i-limb mobile app must be downloaded from the
• Please ensure that you select the my i-limb app shown by
• The iPod (sold separately) connects to your i-limb select via
• The my i-limb mobile app is compatible with the following
• To exit the application at any time, simply press the main
®
Apple
App store
the grey and white logo
a Bluetooth connection, which is automatically established when you start the my i-limb app
devices: iPhone® (4s or newer), iPad® (4th generation or newer), iPad® mini, iPod® (5 or newer).
“Home” button on the front of your mobile device.
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7.2 Getting started
For general instructions on using your iPod Touch (sold separately), read the quick start guide provided by Apple in the packaging of your iPod Touch.
The rst time that you use the device you will need to be connected to the Internet via the iPod’s Wi-Fi connection. You can connect to a Wi-Fi network by tapping on the “settings” icon on the rst screen.
Next go to the App Store via the icon. Tap on it to start the app. To search for the my i-limb app, type “Touch Bionics” or “my i-limb” in the search tab and download the app to your iPod.
Note: an Apple ID will be required to down load the app. If you do not have one, please create an account by logging on to the Apple website or using another mobile device.
After installation of my i-limb
Upon downloading the my i-limb mobile App, an icon will appear on your screen. Tap on it to start the app.
Activation
The rst time you connect to my i-limb, you will see the “Sign in” screen. Here you will need to enter the email address and password that you use when you log-in on the Patient Care Pathway on Touch Bionics’ web site. If you need to create an account, you may also do so by selecting “Register” on the screen below.
Note
Touch Bionics recommends using the latest Apple iOS for best performance. If you are using an older version of iOS, you may receive a one-time notice. Tap “Continue” to acknowledge.
You will need to activate your account by conrming the email sent to the email account you provided prior to being able to connect. Upon registering, please review the Terms and Conditions. Tap “Accept“ to continue.
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Firmware Updates
Touch Bionics‘ always recommends that you download the latest rmware for your device. If a rmware update is available, you will be prompted with the following screen upon connection to biosim.
Tap "Apply“ to initiate the update. Tapping "Cancel“ will dismiss this screen.
Firmware Updates
Tapping "Apply“ will bring you to the rmware update warning screen. Ensure you read and comply with all warnings. Tap "Continue with update" to proceed.
Note: Ensure that you are able to perform the update without interruption. Loss of power or hand communication could result in your device locking, which will require service by Touch Bionics. Total update time may take up to 10 minutes.
After tapping "Continue with update" you will arrive at a nal conrmation screen. Tap "Yes" to continue.
At the conclusion of the update you will be prompted to turn your device o and back on again to complete the update.
After powering o and on, tap "Reconnect" to continue using the biosim app.
After tapping "Yes" the update will begin. You will see a variety of screens as the update progresses. Update screens may vary depending on device updated.
Connection
After signing in, you will be brought to the connection screen where you will tap your device to connect.
Searching for another device
Tap the search icon to disconnect from the current hand at any time and search for a dierent hand. You will be prompted to conrm.
Part number: MA 01155 Issue No. 4, January 2015
Tap No to return to the app
Tap Yes to disconnect.
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When the hand is turned on and is ready to connect the screen will show this display.
Tap the desired device to begin connection process
Authorized User Access
In order for someone else to gain access to your device you will need to tell them your 5 digit security code. This unique code can be found in the “About“ section of the my i-limb app discussed later. They will be prompted to enter this after selecting your device.
In order for a clinician to access your device you will need to tell them your 4 digit serial number located on the wrist plate near the thumb. They will be prompted to enter this after selecting your device.
Accidental disconnection
If the hand should disconnect from the app due to loss of power or proximity with the device the screen at the right will appear.
If the app is unable to connect to the selected hand, the screen at the right will appear.
Turn the hand o and back on, then make sure the hand is functional.
Tap search to try again
Favorites
Here you can assign groups of grip patterns and triggers a single name to make them easily accessible with a single tap.
Tap Reconnect to re-establish the connection
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Editing favorites
Tap the edit button at the top right and the screen changes to look like the one seen here to the right
Editing favorites
To change the name tap here
Tap here to change the icon associated with the favorite.
Tap to red symbol to delete the favorite
Grab the handles and drag to change the order of the list
Tap the name of the entry to edit the favorite
Editing favorites
Tap an icon to choose one to associate with the favorite you are editing.
Tap here to change the features and triggers that will be sent to the hand when this favorite is activated from the favorite list.
Editing favorites
Tap an icon to choose one to associate with the favorite you are editing.
Editing favorites
Edit the trigger associated with the previously tapped feature.
Tap a trigger to change the association.
Tap the features button in the top left to return to the list of features
Part number: MA 01155 Issue No. 4, January 2015
Editing favorites
Once all changes have been made use the top left button to navigate back to the screen at the right.
Tap the Save button to permanently store the changes in the list of favorites.
Favorites are not stored in the hand, only within the app.
Favorites are device specic, meaning you can have dierent favorites for each hand.
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Save a new favorite
To save a new favorite with the currently active features and triggers, tap the + button.
Save a new favorite
Tap the text eld to type in a name for the new favorite
Tap the Icon entry to choose an icon for the new favorite
Save a new favorite
Tap an icon to choose one for the new favorite
Save a new favorite
Switch to the favorites page by tapping on the heart.
Notice the presence of the new favorite created in the last several slides.
Save a new favorite
Tap the save button to add the new favorite to the list of all favorites.
You can also tap the cancel button to abort the creation of the new favorite.
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Currently active features and triggers
The settings pages present the user with the currently active hand conguration.
Any changes made on the settings pages are sent to the hand and take eect immediately.
Currently active features and triggers continued...
Tap a feature icon to change its trigger association
Currently active features and triggers continued…
Tap a trigger to change its association with the selected feature
Other features
This page can be used to enable or disable the various global features of the hand.
Currently active features and triggers continued…
This is an example of the features page after the changes from the previous page.
Notice the highlighted feature with the trigger name under it. This indicates the Hold Open trigger will cause the hand to enter the thumb precision pinch closed feature.
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Real time graph
The real time graph will show the user’s input signals and is best viewed in landscape mode. It shows red for the open signal and blue for the close signal.
Rotate the device to portrait mode or tap the Done button to exit the graph.
Tap the camera button to save a snap shot to the camera roll.
Use the swipe gestures to scroll the graph backwards and forwards to review up to 2 minutes of history.
Multilingual support
You can choose which language should be used by the app.
Choosing system default will make the app use whatever language the rest of the device is using.
Signing out
You will be prompted to conrm the sign out choice as this cannot be undone.
Tap No to return to the app.
About the app
Gives information about the hand and the app.
Tap sign out to disconnect the app from the current PCP account.
Tap Yes to sign out.
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8.0 Support Information
8.1 General Safety,Warnings and Precautions
i-limb select
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 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 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 select.
Do not use an i-limb device to operate your mobile device whilst it is connected to a mains outlet, as this can aect EMG signal.
Failure to comply with the above guidelines will invalidate the warranty.
Batteries
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 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 with new battery
• do not re-use
• dispose of any leaking batteries in an appropriate manner
Failure to comply with the above guidelines will invalidate the
warranty.
Part number: MA 01155 Issue No. 4, January 2015
If you experience technical problems with the i-limb select contact your local distributor
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8.2 Troubleshooting
Problem
Hand does not operate
One digit does not operate
Hand stops halfway during an action
User complains that the hand is dicult to operate
Battery charge does not last a full day
The hand will open but not close
Hand opens when a close signal is provided
Actio
n
Ensure the hand is switched on
Ensure the battery is connected
Ensure the battery is charged
Ensure the hand is engaged at the wrist
Check the electrodes have good contact
Check that the electrode cable is installed correctly (grey side out)
Exchange digit with an alternative working digit from same or dierent i-limb select and re-check. If replaced digit works, contact your distributor
Electrode settings may need to be adjusted
Check the electrode cable is not damaged
Check the battery cable is not damaged
Check that the i-limb select is connected correctly to the wrist
Contact your local distributor
Electrode settings may be too low
Ensure the battery has good charge
Ensure the electrodes maintain good contact
Check electrode placement and wiring
Contact your local distributor
Fully charge the battery overnight. Check the battery connection
Ensure electrodes are not set above 5.5
Check user is not holding a sustained signal to the hand
Replace the battery
Contact your local distributor
Check that the electrode cables are attached are making good contact
Check the hand is engaged at the wrist
Check electrode operation by swapping the electrode connections at the lamination ring
Contact your local distributor
Reverse the connections at the lamination ring
Battery is not working Check the battery is connected
Part number: MA 01155 Issue No. 4, January 2015
Check the battery is charged
Check the wiring for signs of damage
Ensure that the charging port is not compressed by the inner and outer socket interface
Ensure the male connector from the charger is fully inserted into the charger port
Ensure that the connection between charger lead and port is good
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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 dierences 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 to 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;
• moving the thumb into the lateral position and partially closing the ngers to allow the i-limb to be removed
from the steering wheel without opening the hand;
• switching o the i-limb device. This is due to the possibility of involuntary muscle signals being generated.
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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9.0 Appendix
9.1 Technical Information
i-limb select
Voltage 7.4 V (nominal)
Max. Current 5 A
Battery Capacity
Max hand load limit (static limit) 90kg/ 198lb
Finger carry load (static limit) 32kg/ 71lb
Time from open position to full power grip 1.2 seconds
Device Weight
9.2 i-limb select information
The i-limb select device is not intended for use outside the boundries of the environments listed below. The cus-
tomer or user of the i-limb select device should assure that it it not used in such environments
Condition Level
Maximum temperature
Rechargeable lithium polymer; 7.4 V (nominal);
1,300 mAh capacity
Weight with quick disconnect wrist 469g (small) and 479g (medium)
Hazardous Area Classication
+70˚c
Minimum temperature
Hazardous Area Classication
9.3 Component Compatibility
9.3.1 EMC and Electrical Information
Please refer to www.touchbionics.com/downloads/document-library for Electro Magnetic Compatibility (EMC) and Electrical
Information for i-limb products.
Part number: MA 01155 Issue No. 4, January 2015
-40˚c
Non-Hazardous
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9.4 Warranty
Limited Warranty for i-limb select
Touch Bionics warrants that the i-limb select will conform to its specications and be free of defects in material and/or workmanship for twelve (12) months from the date of Touch Bionics invoice for the i-limb select. This Limited Warranty applies only to an i-limb select provided by Touch Bionics or an aliate authorized by Touch Bionics to provide the i-limb select. This Limited Warranty applies to all components including but not limited to xtures, motors, bearings, and electronics. This Limited Warranty is governed by UK law and is not transferrable.
Warranty:
Touch Bionics reserves the right to credit, repair or replace an “in-warranty” i-limb select as its option. The wearer shall report any defect claim directly or to the facility that provided the i-limb select immediately upon discovering the defect, and, in any event, within the warranty period.
The defective i-limb select must be returned to your Practitioner/Supplier.
The unit must be in assembled condition and include an approved covering when returned. The warranty is void if the i-limb select is subjected to abuse, neglect, alteration, modication, improper repair and/or maintenance performed by anyone other than Touch Bionics or a Touch Bionics’ aliate.
Damage resulting from installation of parts and accessories not compatible with the i-limb select by anyone other than Touch Bionics or an aliate is not covered, including use of non-Touch Bionics batteries. The warranty is void if damaged covers are not replaced or repaired in a timely manner by a Touch Bionics cosmesis facility or another facility authorized by Touch Bionics, or if an approved covering is not worn at all times when the i-limb select is being worn.
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 damage or punitive damage to the maximum extent permitted by law. This is the only warranty made by Touch Bionics on the i-limb select and 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 extended.
This Limited Warranty gives the consumer specic legal rights. The consumer may also have other legal rights which vary from country to country. 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 aect any other provision of this limited warranty and all other provisions shall remain in eect.
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Page 50
Consult instructions for use
Class II equipment – provides double Isolation to protect against
Degree of protection – IP40
el
ectric sho
ck
IP40
Protection against penetration by solid particles with diameters larger than 1 mm. No special protection against penetration by water
Serial Number
For i-limb select devices:
The unique serial number for i-limb ultra revolution devices is a “Q” with a 4 digit alpha / numeric number.
WEEE Compliance
Customer Service/Contact Information:
Touch Bionics, Unit 3 Ashwood Court, Oakbank Park Way, Livingston EH53 0TH , UK
Tel: Customer Service: +44 (0) 1506 438 556
Part number: MA 01155 Issue No. 4, January 2015
Catalogue nu
Manufacturer/Date of Manufacture
European Conformity
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mber
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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 2015 Touch Bionics Inc. and Touch Bionics Limited. All right s reserved.
MA 01155 Issue No. 4, January 2015
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