S e r v i c e a n d F i t t i n g M a n u a l

S e r v i c e a n d F i t t i n g M a n u a l

This symbol signifies important information and is used throughout the manual. Kit Contents i-limb Pulse i-limb Skin & Silicone Adhesive Battery Battery Charger Battery Blank & Velcro Bluetooth connector (Clinician) Bluetooth connector (User) BioSim Manual User Manual Fitting and Service Manual Socket Component Kit (optional) Spare Parts Kit Contents Digit Screws Fairing Screws Torx Screwdriver Spanner This document provides instruction for the prosthetist in the fitting and servicing of the i-limb Pulse. p a g e

Table of Contents Page Safety Guidelines... 4 Storage and Maintenance... 5 Product Description... 6 Part Description... 7 Socket Interface System... 8 Electrode Site Selection...12 Socket Interface Fabrication...13 Battery Installation...23 Battery Installation Issues...24 Battery Charging...26 Powerpack Charger Instructions...27 Connecting the i-limb Pulse to the Wrist... 29 Disconnecting the i-limb Pulse from the Wrist... 31 Connecting a Wrist Disarticulation i-limb Pulse to the Wrist... 32 Disconnecting a Wrist Disarticulation i-limb Pulse from the Wrist... 34 Donning the i-limb Skin...36 Doffing the i-limb Skin...38 Covering Repair Instructions...39 Donning the Dynamic Flex and High Definition Covering... 40 Doffing the i-limb High Definition Covering... 43 Removing the Thumb and Adjusting Thumb Friction... 44 Installing a Digit...48 Right Hand Dorsal Fairing Torque Requirements... 49 Left Hand Dorsal Fairing Torque Requirements... 50 Palm Fairing (Both Left and Right) Torque Requirements... 51 Digit (Both Left and Right) Torque Requirements... 52 Thumb (Both Left and Right) Torque Requirements... 52 Troubleshooting...53 Frequently Asked Questions...55 User Details...56 Specifications...57 Dumensions...58 p a g e

SAFETY GUIDELINES Please read these guidelines and information before using the i-limb Pulse. Failure to do so may lead to risk for product malfunction or even a potential hazard to your health, and may lead to an invalidation of the warranty. Do not use this hand under water. Do not use this hand to operate heavy/industrial machinery or any type of machine with moving parts that may endanger yourself or others around you. The user should comply with local regulations on the operation of automobiles, aircrafts, boat/ships, and all other vehicles. Users who are unclear on their legal ability to operate any vehicle should seek the advice of their clinical and legal advisors. Do not use this hand for extreme activities that could potentially injure a natural hand. Do not expose this hand to excessive amounts of moisture, liquid, dust, vibration, or shock. Do not expose this hand to high temperatures. Do not expose this hand to any form of open flame. Do not use this product in an area where a potentially explosive atmosphere exists. Do not attempt to disassemble or modify the product. Only qualified members of Touch Bionics or its partners may perform maintenance, repairs, or upgrades to the product. Failure to comply will invalidate the warranty. Always ensure the i-limb Pulse is covered by an approved Touch Bionics covering. Failure to ensure this will result in invalidating the warranty. The warranty will be made void if damaged covers are not replaced, or repaired by Touch Bionics or an authorized cosmesis partner. Always use The Touch Bionics equipment provided (silicone adhesive, battery charger, screwdriver etc). p a g e 4

Storage and Maintenance When the i-limb Pulse is not in use, switch the hand to the OFF position and store in a cool, dry place. Regularly clean the co-axial plug using a cotton swab and an Isopropyl Alcohol cleaner to keep the connections clear. Battery should be replaced annually for best performance and optimum battery life. LOCATING THE SERIAL NUMBER The hand serial number is etched on the base unit as shown. p a g e 5

Product Description The i-limb Pulse is the newest member of Touch Bionics i-limb family and represents a significant advance for the product line, with a host of enhancements including pulsing grip strength, multiple softwareenabled grip patterns and robust aluminium features for improved user confidence. p a g e 6

Part Descriptions 2 1 5 6 4 3 1. Knuckle 2. Motorized Digit 3. Thumb Rotator 4. Quick Wrist Disconnect 5. Fairing 6. ON/OFF Switch p a g e 7

Socket Interface System Touch Bionics Socket Components Kit Standard Wrist Connector Touch Bionics Internal Battery Lamination Ring Powered Wrist Rotation (optional, supplied by prosthetist) Standard Electrodes Powered Elbow (optional, provided by prosthetist) 4 3 1 & 2 Lock rings 5 6 4 3 p a g e 8

PLO91067A 50Hz - Single Site Socket Kit Quantity 1 Lamination Ring = 50mm 1 2 Lamination Ring = 45mm 1 3 Electrode 50 Hz 1 4 3-Way cable (300mm) with IDC block 1 5 Coupling Piece with large lock ring 1 6 Coaxial plug with small lock ring 1 PLO91068A 50Hz - Dual Site Socket Kit Quantity 1 Lamination Ring = 50mm 1 2 Lamination Ring = 45mm 1 3 Electrode 50 Hz 2 4 3-Way cable (300mm) with IDC block 2 5 Coupling Piece with large lock ring 1 6 Coaxial plug with small lock ring 1 PLO91069A 60Hz - Single Site Socket Kit Quantity 1 Lamination Ring = 50mm 1 2 Lamination Ring = 45mm 1 3 Electrode 60 Hz 1 4 3-Way cable (300mm) with IDC block 1 5 Coupling Piece with large lock ring 1 6 Coaxial plug with small lock ring 1 PLO91070A 60Hz - Dual Site Socket Kit Quantity 1 Lamination Ring = 50mm 1 2 Lamination Ring = 45mm 1 3 Electrode 60 Hz 2 4 3-Way cable (300mm) with IDC block 2 5 Coupling Piece with large lock ring 1 6 Coaxial plug with small lock ring 1 p a g e 9

Compatible Powered Arms Supplier Description Part Number LTI Boston Arm Refer to Product Literature Motion Control Utah Arm 3 and 3+ Refer to Product Literature Otto Bock ErgoArm Electronic plus 12K50 Otto Bock ErgoArm Hybrid plus 12K44 Compatible Wrist Rotator Supplier Description Part Number Otto Bock Electric Wrist Rotator 10S17 For electrical control of the 10S17 Electric Wrist Rotator, six different operation modes are possible with the Myorotronic. The Myoselect 757T13 from Otto Bock is required to change modes. To disenable the wrist rotator motor, use the 9x24 on-off switch from Otto Bock. p a g e 1 0

Compatible Input Devices Supplier Description Part Number Otto Bock Linear Transducer 9X50 Otto Bock 4-Step Linear Transducer 9X51 Otto Bock Myoelectrode 50Hz / 60 Hz 13E200=50, 13E200=60 Otto Bock Harness Pull Switch 9X14 Otto Bock Cable Pull Switch 9X18 Otto Bock Rocker Switch 9x25 Otto Bock Pressure Switch 9x37 LTI Linear Transducer LT01 = 250mm (9.84) LT02 = 500mm (19.68 ) LTI Remote Myoelectrode DC200B = 50 Hz / 60 Hz Motion Control Linear Potentiometer 3010546 Motion Control Procontrol 2 Preamps 3010292 RSL Steeper Myoelectrode SEA200 p a g e 1 1

Electrode Site Selection Touch Bionics recommends the use of a Myo Tester to determine the optimal placement of electrodes. (If using a powered elbow solution, then use the graphical user interface supplied with that elbow). Do not rely on previous myo testing. Be sure to choose sites where the electrode will maintain contstant, even contact with the skin. Avoid placing the electrodes near socket interface trimlines, bony areas, skin grafts, or fatty tissue. In order to achieve effective 2-site control, a 20 mv difference between electrode sites is required. A 40 mv difference is optimal, with the electrode gain no higher than midrange. The i-limb Pulse is optimized for use with electrodes where the gain value is set to the middle of the gain range. If the gains are set to their maximum or minimum, then the user may find it very difficult to control the i-limb Pulse. If the gain is set too high, the electrode may pick up extraneous noise signals and transmit them to the hand, causing unintentional operations of the hand. Also, the window to achieve proportional control is narrowed significantly and makes it very difficult to achieve slower precise movements. If the gain is set too low, then the user may complain that it is too difficult to operate proportional control. The optimal electrode sites are where the user is able to generate the greatest difference between the two electrodes. The user must be able to separate the signals. p a g e 1 2

Socket Interface Fabrication Before fabricating a socket interface for use with the i-limb Pulse, it is important to understand how the design of an External Powered Prosthesis differs from that of a Body Powered Prosthesies. Accessibility to the electronic wiring and motorized parts of the External Powered Prosthesis must be easily and repeatedly achieved. Also, keep in mind that the design principles for upper limb are fundamentally different than those for lower limb. Upper limb prostheses do not require the following: Socket interface design allowing the residual limb to bear the full weight of the body in a vertical load pattern for extended periods of time. Alignable componentry easily adjusted to accommodate changing human gait patterns. Socket interface and componentry design able to withstand forces that equal and exceed full body weight in static and dynamic walking over extended periods of time. Because of the complex electronics and wiring included in the External Powered Prosthesis, the design and fabrication must consider and include: A non-bulky exoskeletal superstructure with access to the forearm hardware, or a removable socket interface to allow access to the forearm space. Room and easy access to accommodate and maintain the various wiring harnesses and electronics essential to the External Powered Prosthesis design. This includes model build-ups, frame fenestrations, and reliefs used to prevent unnecessary binding, pinching, or pulling on wiring, and to allow remote adjustability of electronic hardware. p a g e 1 3

Proper securement of batteries, wiring, and plugs in the superstructure/forearm section. Velcro is supplied for attaching the battery. Ease of regular removal of the socket interface from the exoskeletal socket interface frame. Non-conductive fabrication materials. Note that carbon fiber is a conductor. If carbon fiber is to be used for strengthening and ultralite purposes, avoid placing carbon fiber in areas directly adjacent to the electrodes, and be sure to earth the electrodes to the socket interface frame. LTI remote electrodes are easily earthed via a wire with grounding washer from the middle grounding electrode connection to the carbon fiber socket interface. Otto Bock electrodes require a grounding wire spliced in-line with one of the electrode ribbon cables, as shown in the picture below. p a g e 1 4

Lightweight construction that is durable enough for long-term use. Materials that are strong enough to handle the usual impacts encountered by the forearm. Smooth, flat surfaces that allow for congruent fitting of hardware. This includes: Spotfacing drilled surfaces to accommodate screws, nuts, and panel-mounted electronics such as charger ports. Smooth surfaces that prevent unnecessary edge pressure on wires and electrical connections. Use of proper dummy mounts and templates for hardware placement. We also highly recommend that you design and fabricate a clear diagnostic prosthesis with all the components as if ready to deliver. This prototype prosthesis can then be used for a trial phase to allow you to identify any problems before completing the definitive fabrication. Patients may suffer from excess perspiration in the socket area, which can adversely affect the operation of the hand over time. Please consider antiperspirant options for patients with this condition. p a g e 1 5

Battery Selection and Placement Choose a battery from the chart below according to the space requirements of the socket interface and the needs of the user. Because the battery is designed to be mounted inside the socket interface, ensure that there is adequate space between the end of the residual limb and the wrist (or elbow) to accommodate the battery, the charger port, and any other componentry. Use the battery dummy to fabricate a relief for the battery in the socket interface. i-limb Battery SA000229B (D.C. Socket) and SA000193A (Switch) i-limb Low Profile Battery SA000230B (D.C. Socket) SA000192A (Switch) Capacity 2400 mah 1300 mah Dimensions 71mm (2.8") x 37mm (1.45") x 20mm (0.79) Each cell: 64mm (2.5") x 35mm (1.4") x 6mm (0.236) Can be placed on top of each other or side by side Application Heavy use Medium use Battery Dummy Dimensions Part Number 000019B 72mm (2.83") x 37mm (1.45") x 20mm (0.79) Single Cell (Part Number 000178A): 70mm (2.75") x 35mm (1.38") x 6.5mm (0.26) Dual Cell (Part Number 000179A): 70mm (2.75") x 35mm (1.38") x 613mm (0.51) p a g e 1 6

A switch block may be installed to allow the on/off switch to be moved further up on the forearm for easier access. The switch block also provides an additional accessory switch for temporarily disabling an electric wrist rotator or other electrical device. When the switch block is used in combination with an electric wrist rotator, the switch block will turn both the i-limb Pulse and the electric wrist rotator off simultaneously. Use of the optional switch block replaces the need for the supplied charger port, because the switch block has a built-in charger port. Do not over tighten the nut on the charger port or you may damage it, resulting in ineffective battery charging. p a g e 1 7

Charge Port Lamination Guide M8 Nut M8 Flat Washer M8 Lock Washer Ensure M8 lock washer and M8 flat washer are in place before tightening the M8 nut onto the charge port thread. The presence of the washers is vital to ensure the charge port is not damaged by over tightening. Intact charge port Damaged charger port caused by over tightening nut without washers in place. This would result in the battery not charging. p a g e 1 8

3.2mm (1/8 ) In order to leave enough thread engagement for the two washers and the nut allow for a minimum of 3.2mm (1/8 ) of charge port protrusion. In addition, it is advised that a reverse spotface tool is used on the inner surface of the prosthetic frame in order to level off the charge port mounting face. Following this process will allow for the charge port to sit flush with the frame and further reduce the possibility of damaging the charge port on assembly. p a g e 1 9

Allow at least 2mm of space between the charger port or switch block and any other object inside the socket interface frame. Ensure that a flat surface area inside the socket interface frame is provided for securing the charger port or switch block to the socket interface frame. Pay careful attention to the shaping of the humeral or forearm section over the battery dummy. Charger Port 2mm } Socket Interface/ Residuum Frame (forearm) For very long residual limbs, when the void between the end of the socket interface and the lamination ring is too small to house a battery, it may be necessary to place the battery against the side of the socket interface between the exterior frame. Selection of 1300 mah battery or the 2400 mah battery will be dependent upon the final shaped profile of the forearm. For slender forearms, the 1300 mah may be required. In some situations, it may be necessary to situate the battery dummy somewhere directly adjacent on the actual socket interface between the frame: When the battery is too large for the allocated space in the socket interface frame When the residual limb is longer than 60% of the humeral or forearm section of the prosthesis When the residual limb is an elbow or wrist disarticulation p a g e 2 0

1300 mah Low Profile Battery Configurations Wiring constraints allow for a maximum distance of 135mm between the two cells. p a g e 2 1

Wiring Schematic for 1300 mah Low Profile Battery with D.C. Socket 2.5mm D.C. Socket Co-axial Bush/Rotator Low Profile Battery Cells Placed Side by Side Wiring Schematic for 1300 mah Low Profile Battery with Switch Block SA000219B Switch Block Power Cable SA069031A Switch Block SA069080A Switch Block with Flying Leads Co-axial Bush/Rotator Low Profile Battery Cells Placed Side by Side p a g e 2 2

Battery Installation The Touch Bionics standard and slim line battery packs have been specially designed to meet the power requirements of the i-limb Pulse. Use of any other battery with the i-limb Pulse will invalidate the warranty. Attached to the i-limb Pulse battery is a right-angled charger port which is supplied with a securing nut. To install the charger port: 1 Drill a 5mm diameter hole. If installing the switch block instead of the charger port, note any difference in size between the charger port panel mount and the switch block panel mount. Drill the panel mount hole size accordingly. 2 Slot the screwed segment of the charge port through the socket interface shell. 3 Secure with the locking nut. Use the supplied Velcro for attaching the battery to the inside of the socket interface. Cutting or modifying the battery wires in any way will invalidate the warranty. Take care not to damage or apply excess force to the charger socket interface during assembly to the socket interface. Bending or shaping the battery will affect battery life and may cause the battery to swell. Do not apply constant pressure to the battery when assembled in the socket interface. p a g e 2 3

Battery Installation Issues Batteries must never be bent. Any battery with a bend should be replaced immediately: Result of bending the battery, causing the cells to rupture. This could pose a burn hazard to the wearer! Bend in Battery WARNING: Every practitioner should carefully read the following Battery Safety Instructions, and review with the user the Battery Safety Instructions, prior to charging or using the lithium polymer batteries. Failure to follow the Battery Safety Instructions when charging or using the lithium polymer batteries may result in leakage, fire or explosion which could result in property damage and/or personal injury such as burns. Touch EMAS, Ltd, its subsidiaries, affiliates, distributors/dealers, and its employees or agents disclaim and are released and held harmless from all liability for any and all damages arising directly or indirectly from a failure of the practitioner or the user to comply with the battery safety instructions contained below. A lithium polymer damaged battery should be returned to Touch EMAS, Ltd immediately. p a g e 2 4

Please follow the warnings listed below for all batteries supplied by Touch Bionics: Do not bend and immediately replace any battery if it becomes bent or otherwise damaged Do not compress or pierce Do not disassemble Do not expose to high temperatures Do not incinerate Dispose of properly in accordance with all applicable federal, state, EU legislation and local regulations Only use specified charger Never store battery inside a car at extreme temperature as this could ignite the battery Do not cut the terminal wires, if the wires touch each other a short circuit will occur, potentially causing a fire Do not short circuit, this could potentially cause a fire If at any time you are aware the lithium polymer battery is ballooning or has ballooned or has swelled up, discontinue the charging process immediately, disconnect the battery, remove it to a safe area, and leave it, preferably under observation, for approximately 15 minutes. Ballooning or swelling of a battery may cause battery leakage which could result in fire when the leakage reacts with air. A ballooning or swelling battery should be replaced immediately Any questions regarding these Battery Safety Instructions, the lithium polymer batteries or for the location to return a damaged battery should be directed to Touch EMAS, Ltd at Tel: +44 1506 438 556 p a g e 2 5

Time to Charge Battery from Full Discharge 1300mAh: 3 hours 2400mAh: 6-7 hours Battery Charging When charging the battery, remove the prosthesis from the residual limb and switch the hand to the OFF position. ON OFF The battery should be fully charged before the initial use of the i-limb Pulse, and at the end of every day. To ensure compatibility and optimum performance, use ONLY the Touch Bionics i-limb Pulse Powerpack Charger, as supplied. Attach the battery to the charger as shown on the following pages. A battery charging cycle lasts for 7-8 hours, but the battery is fully charged after approximately 4 hours. To preserve the battery charge, switch the hand to the OFF position when the hand is not in use. Battery should be replaced annually for best performance and optimum battery life. p a g e 2 6

Powerpack Charger Instructions Input: 100-240 V AC 50 to 60 Hz Output: 8.4 V Charging current: 0.8 A max 1 In order to charge, please ensure that the charger plug is pushed firmly into the battery charging socket until an audible click is heard. 2 Connect the charger to a power outlet. The charging sequence is outlined on the next page. CORRECT 3 Remove the charger from the socket by holding the connector (not the lead) and pulling straight out of the socket. Pulling on the lead instead of the connector will likely cause breakage. INCORRECT This charger is only for use with Touch Bionics Powerpack products. Damage resulting from pulling on lead instead of connector. p a g e 2 7

The charger operating sequence (assuming a fully discharged battery) is as follows: Standby Pre Charge Rapid Charge Maintain Ready Description The charger is assessing how much voltage remains in the battery. The battery is being charged from a state of deep discharge to 5V. The battery is being charged from 5V to maximum capacity. In order to prolong the operating life of the battery, the charger will trickle charge the battery for approximately 3.5 hours. At this point the battery is fully charged and ready to use. Maintain mode is finished, and all power to the battery has been cut off. Indicated on the charger by: Solid yellow LED Slow flashing green LED Rapidly flashing green LED Slow flashing green LED Solid green LED Addtional charger indications: Error Ensure that the charger plug is fully inserted into the battery charging socket and power cycle charger. If the error message persists, return the charger and battery to Touch Bionics for inspection. Rapidly flashing yellow LED p a g e 2 8

Connecting the i-limb Pulse to the Wrist 1 Place the hand against the wrist coupling. 2 Push firmly and twist until the mechanism engages. 3 Check the security of the connection by pulling firmly on the hand away from the wrist. p a g e 2 9

4 Set the ON/OFF switch to the ON (right) position. QWD Release Tool (091084A) If an attempt is made to connect the hand while the balls in the Quick Wrist Disconnect are activated, it will not be possible to insert the hand into the socket interface. In this situation the QWD Release Tool can be used to reset the ball retainer. This end eases the fitment of the Locking Ring for lamination ring/ coupling piece assembly. This end resets an accidentally activated Quick Wrist Disconnect. p a g e 3 0

Disconnecting the i-limb Pulse from the Wrist 1 Set the ON/OFF switch to the OFF (left) position 2 Rotate the hand approximately 360 degrees in either direction until you feel slight resistance. Once this resistance is overcome, the hand will disconnect from the wrist. p a g e 3 1

Connecting a Wrist Disarticulation i-limb Pulse to the Wrist 1 Remove the fairing as per the instructions on page 40 2 Align the slots on the Wrist Disarticulation Plate with the studs on the base of the i-limb Pulse. 3 Slide the Wrist Disarticulation Plate onto the base of the i-limb Pulse. p a g e 3 2

4 Tighten the securing screw using the torx screwdriver supplied. 5 Replace the fairing as per instructions on pages 42 and 43. When laminating the Wrist Disarticulation Plate into the socket, provision must be made to allow the slots to connect with the studs on the base of the i-limb Pulse. p a g e 3 3

Disconnecting a Wrist Disarticulation i-limb Pulse from the Wrist 1 Remove the fairing as per the instructions on page 40. 2 Loosen the securing screw using the torx screwdriver supplied. 3 Slide the Wrist Disarticulation Plate off the base of the i- LIMB Pulse. p a g e 3 4

4 Lift the i-limb Pulse up and off the Wrist Disarticulation Plate. p a g e 3 5

Donning the i-limb Skin 1 Position the thumb of the i-limb Pulse to approximately 15mm (0.6 inches) away from the i-limb Pulse index finger 2 Rotate the thumb so it is positioned opposite the palm and place the i-limb Skin over the fingers of the i-limb Hand. 3 Gently pull the i-limb Skin up and over the thumb taking care not to cause any undue downward pressure on the thumb. p a g e 3 6

4 Pull the i-limb Skin down over the i-limb Hand to the wrist. 5 Individually pull the i-limb Skin fingers over the i-limb Hand fingers until fully aligned. p a g e 3 7

Doffing the i-limb Skin 1 Position the thumb of the i-limb Hand to approximately 15mm (0.6in) away from the first finger. 2 Gently pull the i-limb Skin from the wrist up and over the base of the thumb, taking care not to cause any undue downward pressure on the thumb. 3 Grip the tips of the i-limb Skin fingers and gently pull it up and off the i-limb Hand. p a g e 3 8

Covering Repair Instructions Remove covering from hand, as per page 38. 1 2 3 Identify damaged area. Pinch the damaged area as per Image 2. Note that the thickness of the material is facing outwards. Apply a small amount of silicone adhesive (supplied by Touch Bionics) to the damaged/cut area. 4 5 6 Using a flat disposable utensil (not supplied) spread adhesive evenly over the full length of cut. Remove pressure from the pinch, allow skin to settle and immediately remove excess silicone gently with a paper towel. Allow silicone to dry/harden undisturbed for 30 minutes. p a g e 3 9

Donning the Dynamic Flex and High Definition Coverings 1 Spray the inside of the Covering generously with the IPA (Isopropyl Alcohol). 2 Invert the Covering up to the base of the fingers. 3 Push out the fingers inside the inverted Covering using the spatula provided. This will help the skin slide onto the extended i-limb Hand fingers p a g e 4 0

4 Spray the inside of the inverted Covering generously with IPA (Isopropyl Alcohol) lubricant/cleaner. 5 Position the thumb of the i-limb Hand to approximately 15mm (0.6 inches) away from the first finger. Then rotate the thumb so it is positioned away from the palm. 6 Slide the Covering onto the four fingers of the i-limb Hand. p a g e 4 1

7 Place the base of the thumb covering onto the thumb of the i-limb Hand. 8 Gently pull the Covering up and over the thumb taking care not to cause any undue pressure on the thumb and gently retract the covering down over the i-limb Hand. p a g e 4 2

Doffing the i-limb High Definition Covering 1 Position the thumb to approximately 15mm (0.6 inches) away from the first i-limb Hand finger. Then rotate the thumb so it is positioned away from the palm. 2 Spray the outside of the Covering generously with IPA (Isopropyl Alcohol) lubricant/cleaner (provided by Touch Bionics). 3 Invert the Covering gently up and over the thumb up to the base of the fingers. 4 Remove the Covering entirely by pulling the fingers of the covering off the i-limb Hand. p a g e 4 3

Removing the Thumb and Adjusting Thumb Friction 1 Remove the torx screw using the torx screwdriver provided by Touch Bionics 2 Carefully lift the fairing from the hand, taking care not to damage the attached wires. Caution: wires are attached to fairing 3 Rotate the thumb as far as it will go towards the back of the hand. While supporting the thumb, use the provided screwdriver to loosen the screw. p a g e 4 4

4 Lift the thumb out of the thumb rotator. 5 Use the thumb spanner provided to tighten/loosen the nut within the thumb rotator housing. Tightening increases the force required to rotate the thumb. Loosening decreases the force required to rotate the thumb. p a g e 4 5

6 Once you have achieved the desired friction, place the thumb back in the thumb housing and replace the screw. Tighten the screw with the provided screwdriver. 7 Carefully replace the fairing onto the hand, taking care not to damage the attached wires. Caution: wires are attached to fairing p a g e 4 6

8 Replace and tighten the torx screw using the torx screwdriver provided by Touch Bionics. CAUTION: DO NOT OVERTIGHTEN SCREWS p a g e 4 7

Installing a Digit 1 Place the digit into the knuckle block. 2 Insert the torx screw into the knuckle block. 3 While supporting the tip of the digit, provide a little pressure to keep the digit located in place while tightening the torx screw. CAUTION: DO NOT OVERTIGHTEN SCREWS. NOTE: If any resistance is felt while tightening the screw, the screw may be cross-threading. Remove and re-insert the screw. p a g e 4 8

RIGHT HAND DORSAL FAIRING TORQUE REQUIREMENTS Attach the Fairing Dorsal to the chassis, complying with the following data tables, 1 2 3 WATCH THAT WIRING HAS NOT BECOME PINCHED BY THE FAIRING 1 1 2 3 Attachment: Tool: Screw/nut: Torque: Attachment: Tool: Screw/nut: Torque: Attachment: Tool: Screw/nut: Torque: Fairing Dorsal RHM to Pulse Chassis RH Torque driver with TX10 attachment M3x8 TX10 Pan Head Nylon Patch 1Nm Fairing Dorsal RHM to Pulse Chassis RH Torque driver with TX10 attachment M3x6 TX10 Pan Head Nylon Patch 1Nm Fairing Dorsal RHM to Pulse Chassis RH Torque driver with TX10 attachment M3x6 TX10 Pan Head Nylon Patch 0.75Nm p a g e 4 9

Left HAND DORSAL FAIRING TORQUE REQUIREMENTS Attach the Fairing Dorsal to the chassis, complying with the following data tables, 2 1 3 WATCH THAT WIRING HAS NOT BECOME PINCHED BY THE FAIRING 1 2 3 Attachment: Tool: Screw/nut: Torque: Attachment: Tool: Screw/nut: Torque: Attachment: Tool: Screw/nut: Torque: Fairing Dorsal LHM to Pulse Chassis LH Torque driver with TX10 attachment M3x8 TX10 Pan Head Nylon Patch 1Nm Fairing Dorsal LHM to Pulse Chassis LH Torque driver with TX10 attachment M3x6 TX10 Pan Head Nylon Patch 1Nm Fairing Dorsal LHM to Pulse Chassis LH Torque driver with TX10 attachment M3x6 TX10 Pan Head Nylon Patch 0.75Nm p a g e 5 0

PALM FAIRING (BOTH LEFT AND RIGHT) TORQUE REQUIREMENTS 4.31 Attach the Fairing Palm to the chassis, complying with the following data table. WATCH THAT WIRING HAS NOT BECOME PINCHED BY THE FAIRING Attachment: Tool: Screw/nut: Torque: Fairing Palm to Pulse Chassis Torque driver with TX10 attachment M3x8 TX10 Pan Head Nylon Patch 0.75Nm p a g e 5 1

DIGIT (BOTH LEFT AND RIGHT) TORQUE REQUIREMENTS 6.3 Attach the 4 fingers as per the configuration above and comply with the following data table in order to set the screws to the correct torques, Attachment: Tool: Screw/nut: Torque: Fingers to Pulse Knuckle Block Torque driver with TX10 attachment M3x12 TX10 Pan Head Nylon Patch 1.75Nm THUMB (BOTH LEFT AND RIGHT) TORQUE REQUIREMENTS 6.4 Attach the thumb to the pulse thumb rotator, complying with the following data table, Attachment: Tool: Screw/nut: Torque: Thumb to Pulse thumb rotator mount Torque driver with TX10 attachment M3x8 TX10 Pan Head Nylon Patch 1Nm p a g e 5 2

Troubleshooting Contact Touch Bionics if any problems persist. Problem Hand does not operate. Action Check on/off switch. Is the battery connected? Is the battery charged? Is the hand engaged at the wrist? Are the electrodes maintaining good contact? Are the electrodes heating up? If so, check that the electrode cable is installed correctly (grey side out). One digit does not operate. Remove the digit and swap with another digit from the same hand. Check if the digit operates correctly, then call Touch Bionics. The hand stops halfway through an action. Electrode settings may be too high. Check the electrode cable is not damaged. Check the battery cable is not damaged. Check whether the i-limb Pulse is connected correctly to the wrist. Contact Touch Bionics. User complains that the hand is hard to operate. Electrode settings are too low. Is the battery charged? Are the electrodes maintaining good contact? Check electrode placement and wiring. Contact Touch Bionics. p a g e 5 3

Problem The battery charge does not last a full day. Action Fully charge the battery overnight. Check the battery connection. Ensure electrodes are not set to 6 or above. And Check user is not holding a sustained signal to the hand. Replace the battery. Contact Touch Bionics. The hand will open but not close. Check the electrode cables. Is the hand engaged at the wrist? Check electrode operation by swapping the electrode connections at the lamination ring. Contact Touch Bionics. The hand opens when a close signal is provided. Swap the electrode connections on the lamination ring. The battery is not working. Is the battery connected? Is the battery charged? Is there any visible damage to the wiring? Has the charging port been sandwiched between the inner and outer socket interface? Is the male connector from the charger fully inserted into the charger port? Does the LED flicker between red and green when the male connector from the charger is rotated? p a g e 5 4

Frequently Asked Questions Q) How often should I charge the battery? A) Charge the battery every night. Q) If I forget to charge the battery at night, how long will it last? A) The speed and grip force of the hand will decrease with the drain of the battery charge. The battery should be recharged if the user feels that the performance of the hand is diminishing. Q) How long will it take to charge the battery? A) 1300mAh = 3 hours; 2400mAh = 6-7 hours Q) How often do I need to replace the battery? A) The battery should be replaced annually for best performance and optimum battery life. Q) A digit has stopped articulating. What should I do? A) Note the hand number and contact Touch Bionics or your local sales representative. If the i-limb Pulse stops working or if you encounter any other technical problems, please contact Touch Bionics as follows: North American Customers (Canada, Mexico & US) Tel: +1-614-388-8075 UK & Non-North American Customers Tel: +44 1506 438 556 p a g e 5 5

User Details It is recommended that the prosthetist fills this section in to act as an easy reference when contacting Touch Bionics. User Name: Fitting Date: Hand Purchase Date: Hand Serial Number: p a g e 5 6

Specifications Voltage 7.4 V (nominal) Max. Current 5 A Index to Thumb Pinch Force 1.25kg; 2.1kg with pulsing Lateral Pinch Force 2.1kg; 3.5kg with pulsing Power Grip Force 10.2kg; 13.9kg with pulsing Load Limits 32kg per digit, 90kg overall Battery Rechargeable lithium polymer 7.4 V (nominal) 1300 mah capacity (slim line battery); 2400 mah capacity (optional) Weight regular Small i-limb Pulse 465 g 460 g When utilizing other manufacturers componentry to hybridize a prosthesis, please ensure that all electrical components are compatible. For a list of compatible components, please contact Touch Bionics. p a g e 5 7

Dimensions 80mm/3.17" 75mm/2.93" 120mm 4.73" 118mm 4.63" 45mm/1.77" Regular 45mm/1.77" Small 80mm/3.17" 75mm/2.93" 120mm 118mm 4.63" 46mm/1.81" Regular Wrist Disarticulation 46mm/1.81" Small Wrist Disarticulation p a g e 5 8

35mm/1.39" 182mm 7.18" 36mm/1.43" 180mm 7.09" 41mm/1.61" 22mm/0.87" 22mm/0.87" 42mm/1.65" Regular 42mm/1.65" Small 35mm 1.39" 182mm 7.18" 36mm 1.43" 180mm 7.09" 42mm 1.66" 70mm/2.76" 70mm 2.76" 42mm/1.67" Regular Wrist Disarticulation 42mm/1.67" Small Wrist Disarticulation p a g e 5 9

w w w. t o u c h b i o n i c s. c o m North American Customers (Canada, Mexico & US) Tel: + 1-614-388-8075 UK & Non-North American Customers Tel: +44 1506 438 556 Email: info@touchbionics.com For address details and further information please visit our website: Website: www.touchbionics.com Third party products and brand names may be trademarks or registered trademarks of their respective owners Touch Bionics, LIVINGSKIN, DermaHair, i-limb Hand, SeasonGuard, i-limb and ProDigits and associated logos are trademarks of Touch EMAS Limited and/or are the subject of trademark applications or registrations in various countries around the world. All Touch EMAS products are subject to continuous research and development we therefore reserve the right to alter technical specifications without prior notice. Touch EMAS products are protected by patent and/or patent applications in various countries around the world. Copyright 2010 Touch Bionics Inc. and Touch EMAS Ltd. All rights reserved. Issue No. 1.0 Jun 2010 Part number: 137020A