i-limb ultra Clinician Manual
Contents
1. Triple impulse three uninterrupted open signals settings are the same as with the Double impulse trigger The impulse i cms l Impulse duration ms 300 The duration is the window of duration is preset at 300ms and can be customised from 30 to j pe opportunity for the open signal to get 3 000ms The impulse period is preset at 1 000ms 1 second Impulse period ms 1000 above the threshold and back below the threshold to b idered and can be customised from 500 to 3 000ms aah r E ERSAT ATERS The period is the total amount of time to accomplish multiple impulses that Done Cancel will activate a trigger The graph shows an optimal triple impulse In a similar manner to 3 the double impulse the three impulses are of sufficient strength to break the threshold The first and second impulses drop below the threshold to allow recognition to subsequent impulses All three ae impulses are activated within the preset impulse period impulse period is not indicated on the graph 2 15 m 0 5 Ee k oaol A PUTA airy O oal Once the trigger is linked to a feature the settings tab appears providing the option to make changes to timings In addition the feature is now labeled with the relevent trigger Any of the above four potential triggers can be linked with any of the above features Some users are able to perform activities of daily life ADL s without the use of any triggers In many case2. 6 3 1 Myo testing The Analog gauges opening myo testing screen provides a very quick and easy method of testing myo site activation The strength of open and closed signals will be illustrated on the gauges the maximum reading will be left 100 100 75 75 as a shadow on the gauge and the actual figure x Myo testing is provided below each scale 25 25 Open signal maximum 70 Reset maximums Close signal maximum 54 Analog gauges Resl me graph The Real time graph screen plots a graph of impulses in real time with open impulses in red and closed impulses in blue The choice of either open or closed input channels is offered e providing the option to make the impulse curve invisible by ss eatin T n Active trigger Not active unticking the Visible box at the top left of the screen D 0 a so oo 100 ols 0 031 037 ode os Gain and Threshold levels are indicated pre set values being 2 o 70 for gain and a threshold level of 0 2V Either can be ae modified depending on the needs of the user On changing 2 the threshold levels and the top of the screen the level is Y S a ee es S E S S S ee B ja automatically changed on the graph ci Jj H f Il s J i Lao f 20 The graph can be paused restarted saved or enlarged using E Ci at Training mode Disabled the control at the bottom of the screen 7 i The graph automatically moves at a pace of
3. Connecting to device will flash The tab marked connect must now clicked for the connection to be made this will take approximately 15 seconds If there is more than one i limb device within range of the Bluetooth receiver then a box will appear listing all devices by serial number In the illustration only one hand is listed The correct i limb device can then be selected from the list The hand serial number is located at the wrist portion of the hand at the base of the thumb as illustrated on page 4 understand and be comfortable working with the technology being able to make appropriate adjustments To use the biosim software with the i limb ultra you will need either an iPod Touch supplied by Touch Bionics and preloaded with the biosim App or a PC loaded with the biosim software and used with the biosim Bluetooth device the system requires either Window XP Windows Vista Windows 7 or Windows 8 Microsoft NET framework v3 5 USB port for Bluetooth connector and administrative rights to install the software and connector Users of biosim via an iPod Touch are directed to iPod Touch with biosim App Quick Start Guide provided with your iPod Touch also downloadable from www touchbionics com Figure 6 Figure 7 Welcome to Follow these three easy steps to connect with a device Insert handshake Turn device off Handshake installed and ready 2 een No You can also choose one of the options b
4. Y OIONICS N This symbol signifies important information and is used throughout the manual Table of Contents 1 i limb ultra 2 Socket 3 Wrist 4 Adjustments 5 Covers 6 biosim 7 Support Information 8 User Information 9 Appendix Part number MA00003 Issue No 2 March 2013 1 1 1 2 2 1 2 2 2 3 2 4 2 5 2 6 2 7 3 1 3 2 3 3 3 4 3 5 4 1 4 2 4 3 5 1 5 2 5 3 5 4 5 5 5 6 6 1 6 2 6 3 6 3 1 6 3 2 6 3 3 6 3 4 6 3 5 6 3 6 6 3 7 7 1 7 2 7 3 8 1 9 1 9 2 9 3 9 4 Product Description Prosthesis Overview Control Sites Socket Fabrication Charge Port Placement Assembly Battery Options Battery Configuration Battery Installation Battery Charging Wrist Connection Options Quick Wrist Disconnect QWD Wrist Disarticulation Flex Wrist Multi flex Wrist Digit Configuration Digit Installation Thumb Installation Cover Options Donning the i limb skin active Cover Doffing the i limb skin active Cover Donning the i limb skin natural Cover Doffing the i limb skin natural Cover Wear and Care Guidelines biosim Overview biosim Connecting Navigating biosim Myo testing Control Strategy Features Training Hand Health Check Usage Exit Storage and Maintenance Troubleshooting Warnings and Precautions User Details Technical Information i limb ultra Information Component Compatibility Warranty 1 1 Product Description The i limb u
5. off the fingers of the i limb ultra one at a time Part number MA00003 Issue No 2 March 2013 29 of 56 5 6 Wear and Care Guidelines for i limb Naturals and Custom Covers Care of the covers is very important in order to maintain its use Accessing the Battery or Switch long term The following are some guidelines for wear and care If access to the charge port or switch is required and it is covered by a glove or sleeve spray the outside with medical rubbing alcohol to reduce friction this will aid partial removal and will also i hel td d by friction Cleaning the Cover elp prevent damage caused by friction Use warm water and plain soap regularly to clean the outside Nails of the cover Using the correct soap is very important brand The nails of the i limb skin natural cover are made of silicone liquid dish washing soaps such as plain Dawn or Ivory are and cannot be polished or painted as this will damage the cover recommended Clean the cover with medical grade rubbing Attaching acrylic nails will invalidate the warranty alcohol once a week to help with disinfection If you have a custom high definition cover the nails may either be silicone or acrylic Acrylic fingernails may be polished as usual Use Some soaps contain additives such as oil perfume only non acetone nail polish remover Silicone nails should not be N hand lotion glycerin or aloe and should be polished avoided Jewelry and Gloves Jewelry is no
6. Part number MA00003 Issue No 2 March 2013 13 of 56 Part number MA00003 Issue No 2 March 2013 3 1 Wrist Connection Options i limb ultra is available with the following wrist options Quick Wrist Disconnect QWD Wrist Disarticulation The following flexible wrist options are available for the i limb ultra Flex Wrist 2 Multi flex Wrist See section 3 4 and 3 5 respectively for FlexWrist and Multi flex Wrist fitting information 3 2 Quick Wrist Disconnect QWD The QWD is supplied by Touch Bionics Disconnection of the i limb ultra fitted with a QWD from the socket is completed as follows Connecting the i limb ultra using the QWD Ensure the i limb ultra is switched off D Align the QWD connection of the i limb ultra with the connection in the forarm socket 14 0f 56 On Off Switch Engage the coupling 4 Test the connection is fully engaged with a slight rotation Disconnecting the i limb ultra using the QWD Ensure the i limb ultra is switched off 2 Support the i limb ultra in the palm of the hand Part number MA00003 Issue No 2 March 2013 15 of 56 Rotate the i limb ultra through 360 in either direction until a click is heard 4 The i limb ultra 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 so
7. but not limited to any implied warranty of merchantability or fitness for a particular purpose are extended This Limited Warranty gives the consumer specific legal rights The consumer may also have other legal rights which vary from country to country from state to state in the U S from province to province in Canada and from state to state in Mexico Some countries and states may not allow the exclusion or limitation of incidental or consequential damages or warranties so the above limitations or exclusions may not apply to you If it is determined by a court of competent jurisdiction that a certain provision of this limited warranty does not apply such determination shall not affect any other provision of this limited warranty and all other provisions shall remain in effect Part number MA00003 Issue No 2 March 2013 56 of 56 Up touch OIONICS North American Customers Canada Mexico and US Touch Bionics 35 Hampden Road Mansfield MA 02048 USA Tel 1 855 MY iLIMB 694 5462 International Customers atal Touch Bionics Unit 3 Ashwood Court Oakbank Park Way Livingston EH53 OTH Scotland Tel 44 1506 438 556 Email info touchbionics com 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 ce Copyright 2013 Touch Bionics Inc and Touch EMAS Ltd All rights reserv
8. of 56 4 0 Adjustments Individual digits for the i limb ultra 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 configuration of the small and medium sized i limb ultra is outlined in the table Thumb 5 6 oo mex PS Midde 5 foo o 6 Little The i limb ultra is only compatible with Touch Bionics i limb ultra 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 ultra is switched off 2 Support the i limb ultra 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 3 Loosen the Knuckle block screw while supporting the digit remove the digit 4 Select the appropriate sized replacement digit and follow the steps in reverse order to replace It is recommended that you discard the used screws as the anti vibration pad on the screw shaft will be deformed during use Digit screws should be replaced using the new screws provided N Do not over tighten screws If there is resistance while tightening the screw check for cross threading by removing and re inserting the screw 4 3 Thumb Installation The i limb ultra is only compatible with Touch Bionics i limb ultra digits To exchange a thumb ensure the correct size has been selected Instr
9. port and switch block components should always be used with the i limb ultra Part number MA00003 Issue No 2 March 2013 Figure 1 Compact Electrode OF 09105205 lt Figure 2 Remote Electrode Figure 3 virtu limb Socket Material The use of Carbon fiber is not recommended due to electrical conductivity if it is required to improve strength N then the carbon fiber lamination must be earthed if used directly adjacent to electrodes see Page 6 Please contact Touch Bionics to order modified electrodes Coupling Piece Assembly 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 Please reference part number PL091084 when ordering Part number MA00003 Issue No 2 March 2013 Battery Placement Use Velcro to position the batteries on the pre prepared flat 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 wrist disarticulation 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
10. signal Ais s enger The presence of tte EMG signal hat exceeds th the hand opens signal B i stronger the hand doses hand cheaing Ary signal Delow the Nra shold o Battery type 1300 mAh the hand opening Swap input channels e r hand openi e i i Using wrist rotator Single Site voluntary opening strategy The presence of the EMG sgnal that exceeds the Presheld seting results n he hand Opening Any signal below Pa Mreshakd or removal of he signa wil resuk nthe hand desing Single site Voluntary Open the presence of a signal above the pre set threshold level results in the hand opening Any signal below the threshold or removal of the signal will result in the hand closing Single site Alternating the presence of a signal above the pre set threshold level results in the hand opening The next signal above the threshold level will result in the hand closing Re grip timeout is the amount of time that must pass with the signal relaxed before the hand will change This allows the user to continue movement in one direction if they did not not fully grasp the object with the first signal Auto revert is the time after which the hand will automatically revert to a close signal regardless of whether or not the next alternating signal would have been open This prevents the user from dropping an item when they do not recall which signal was the most recent Li 34 of 56 Graph showing good separation between input si
11. the presence of the blue closed impulse disrupts the signal The impulse is recognised as a single open signal Encourage the patient to relax the closed impulse during double impulse activation Consider changes to gain and threshold of the closed channel depending on activation during other activities Consider a first over strategy the signal would be accepted using this strategy The graph shows a failed double impulse attempt The double open signals are sufficiently strong however the impulses are too far apart to be identified as one signal Both impulses are recog nised as individual open signals Encourage the patient to reduce the time lag Impulse period Impulse duration inbetween impulses Consider lengthening the impulse period Impulse duration ms 300 The duration is the window of Impulse period ms 1000 opportunity for the open signal to get above the threshold and back below Done Cancel the threshold to be considered an impulse The period is the total amount of time to accomplish multiple impulses that will activate a trigger Impulse period Impulse duration 0 5 a T 42 of 56 The graph shows a failed double impulse attempt using dual 3 site differential The double open signals are sufficiently strong however there is no relaxation between impulses The signal is recognized as an open signal 25 Encourage the patient to relax inbetween impulses
12. 10 seconds per page however can be altered to a speed of between 2 and 60 seconds per page 6 0 amp e amp Training mode option enables training with specific triggers The i limb ultra is optimized for use with electrodes where i l h Z i Cl h the gain value is set to the middle of the gain range If the ree eagle Dai A graph gains are set to their maximum or minimum then the user may find it very difficult to control the i limb ultra Rewind History View Saved Zoom Out If the gain is set too high the electrode may pick up Graph 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 overal function will be effected 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 Part number MA00003 Issue No 2 March 2013 33 of 56 Part number MA00003 Issue No 2 March 2013 6 3 2 Control Strategy The control page provides access to control strategy settings Control strategy is the method by which the i limb ultra responds to the input channels While superior control of the i limb ultra is possible with a dual site strategy it is possible to control the
13. Bluetooth wireless connection provides access to a range of control options training features real time display of impulses battery status and health check While working with the patient user an assessment should be made of their suitability to work with biosim Patient users must 6 2 biosim Connecting Load biosim by clicking on the biosim icon fig 6 which should be clearly visible on the screen The biosim Handshake device fig 7 must also be inserted into a USB port to allow the Blue tooth signal to be received by the i limb ultra The Handshake Bluetooth receiver will pick up signals within a 10 meter range biosim must first be downloaded and is not contained on the handshake device It can be found at http www touchbionics com biosimdownload The opening welcome screen will load The language can now be changed from the default English to either German Spanish French or Italian This is done by clicking on the language indicator at the bottom right hand side of the screen and scrolling to the required language The first numerical icon insert handshake request will flash On insertion of the handshake biosim device the icon will be constantly lit the handshake installed and ready box will then self tick and the second icon Turn device off then back on will begin to flash At this point the i limb ultra should be turned off and then on The second icon will now be constantly lit and the third icon
14. March 2013 46 of 56 6 3 6 Usage The Usage suite provides usage information on the number of power cycles the number of times the hand has been switched on as well as the number of open and close motions for each digit overall Usage Feature count gives the number of times the open and closed command has been used with in a specific grip pattern Excessive Signal Activity Count gives the number of times the user maintained a signal above the threshold level for more than 3 seconds Options to refresh and reset along with saving and illustrating the data are also provided This analysis is very useful when reviewing usage and reliance on the various features of the i limb ultra 6 3 7 Exit Use the Exit icon to fully exit biosim A prompt will be provided allowing you to save the settings for that session for future reference biosim by touch bionics Feature counts Power cycles 23 Power cycles 23 Feature name Open Cose F Open Tose 7 f Open Cose gt Standard precson pinch opened 0 gt Hand 2543 254 gt Hand 545 542 Standard predsion pinch dosed o Thunb 2544 54 Thumb 2544 54 Thumb precision pinch opened 0 Index 2544 54 Index 2544 54 Thumb presion pinch dosed 9 Midde 2544 54 Mddie 2544 54 Standard 3 Jaw chuck tripod opened 0 Ring 2544 64 Rng 2544 64 Standard 3 Jaw chuck tripod dosed 0 utie 254 54 Utte 2546 54 Thunb 3 Jaw chuck roud apened Thumb 3 Jaw chuck tripod dosed Th
15. Motorized Digit Knuckle Palmar Fairing Manual Thumb Rotator On Off Switch 2 1 Control Sites The i limb ultra is controlled by electrodes There are two electrode options available for use with the i limb ultra compact electrodes fig 1 or remote electrodes fig 2 For information regarding the fitting 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 fig 3 Do not rely on previous myo electrical testing Consult Touch Bionics training materials for information on myo testing or section 6 of this manual for information on myo testing within biosim 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 2 2 Socket Fabrication While fabricating the socket for the i limb ultra special consider ations will need to be given to Battery placement size and configuration Electrode position or other control method Charge port placement Socket length and the overall length of the prosthesis in comparison to the opposite side Pa a T Clinicians should have prior experience with building myo electric prosthetic sockets before fitting the i limb ultra Touch Bionics batteries charger
16. cation visit www touchbionics com or call 1 855 MY iLIMB US amp Canada or 44 0 1506 438 556 International The unit must be in assembled condition and include an approved covering when returned The warranty is void if the i limb ultra is subjected to abuse neglect alteration modification improper repair and or maintenance performed by anyone other than Touch Bionics or a Touch Bionics affiliate Damage as the result of normal wear and tear including the result of fatigue is not covered during the warranty period Damage resulting from installation of parts and accessories not compatible with the i limb ultra by anyone other than Touch Bionics or an affiliate 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 cosmetic covering is not worn at all times when the i limb ultra 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 ultra and components and there are no warranties which extend beyond the description herein Any warranties that may otherwise be implied by law including
17. cket frame and then attached to the i limb ultra by the following steps Disconnect the Palm Fairing from the i limb ultra chassis by unscrewing the screw in the palmar surface using a T10 Screwdriver supplied f Part number MA00003 Issue No 2 March 2013 16 of 56 Remove the Wrist Disarticulation and feed the power cable through Align the slots and slide the Wrist Disarticulation plate onto the WD Lamination Plate at base of the i limb ultra ensuring it is firmly engaged Secure the Wrist Disarticulation to the WD Lamination Plate using the T10 screw and T10 Screwdriver supplied Replace the Palm Fairing onto the chassis by hand tightening the screw in the palmar surface using the T10 Screwdriver supplied Ensure that the Palm Fairing does not pinch the wiring 17 of 56 Part number MA00003 Issue No 2 March 2013 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 ultra complete the above steps in reverse Disconnect the Palm Fairing from the Chassis Be careful to not damage wring when removing the Palm Fairing Loosen the Wrist Disarticulation Lamination Plate Screw from the Wrist Disarticulation plate Slide the Wrist Disartic
18. d that the above information is also included in the patient notes Part number MA00003 Issue No 2 March 2013 52 of 56 9 1 Technical Information i limb ultra Voltage 7 4 V nominal Rechargeable lithium polymer 7 4 V nominal 2 000 mAh capacity 1 300 mAh capacity Battery Capacity Max hand load limit static limit 90kg 198lb Finger carry load static limit 32kg 711b Device Weight Weight with quick disconnect wrist 469g small and 479g regular J Weight with Wrist Disarticulation unit 405g small and 418g regular 9 2 i limb ultra information Hazardous Area Classification The i limb ultra device is not intended for use outside the boundries of the environments listed below The customer or user of the i limb ultra device should assure that it it not used in such environments Condition Hazardous Area Classification Zones 0 1 and 2 Part number MA00003 Issue No 2 March 2013 53 of 56 9 3 Component Compatibility General Safety 1 1 The i limb ultra device is an electrical device which under certain circumstances could present an electrical shock hazard to the user Please read the accompanying user manual thoroughly and follow directions stated in the manual to assure maximum safety during charging and operation 1 2 EN 60601 1 2006 1 2 1 Protection against electrical shock Class I 1 2 2 Degree of protection against electrical shock Type BF provides additional protection against elect
19. e the M8 locking nut with the threaded shaft and tighten firmly 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 gt gt D Part number MA00003 Issue No 2 March 2013 2 4 Battery Options Two battery options are available for the i limb ultra both of which have been specifically designed to meet the power requirements of the hand Battery selection should be based on available space within the socket fabrication shape of the residual limb and the expected level of use The corresponding DC socket and switch block will also be required i limb 1 300 mAh Battery i limb 2 000 mAh Battery 70mm 2 76 80mm 3 17 Battery Dimensions i 35mm 1 39 44mm 1 74 6mm 0 24 7 5mm 0 30 69mm 2 77 87mm 3 48 Dummy Battery i 35mm 1 39 45mm 1 80 Dimensions 10mm 0 39 Single cell 11mm 0 44 Single cell 16mm 0 63 Dual cell 19mm 0 76 Dual cell 000231 Single cell DC Socket SA000229 SA000234 Switch Block Block SA000193 SA000192 Part number MA00003 Issue No 2 March 2013 KOK mole aay Gaery a The images opposite show the 1 300 and 2 000mAh battery options with battery dummy The battery with DC connector and battery with switch block connector are shown Only Touch Bionics batteries are approved for use with the i limb ultra Use of alternative batteries will invalidate the wa
20. ed Issue No 2 March 2013 Part number MA000003
21. ed i limb ultra fingers Spray the Silicone on the outside of the inverted cover generously with the IPA lubricant cleaner supplied Position the thumb of the hand opposite and facing the forefinger in the same position as the pinch grip Part number MA00003 Issue No 2 March 2013 27 of 56 Slide the covering onto the four fingers of the hand and work it well down onto the fingers When possible place the thumb hole of the covering over the thumb tip and work the covering over the fingers and the thumb together Once the covering is over the fingers and roughly half way down the thumb take a firm hold of the cover at the wrist end and gently maneuver over the thumb and hand take care not to cause undue pressure on the thumb Note When using the i limb natural cover adjustments should be made within biosim to ensure that speed is not sacrificed Contact Touch Bionics with questions regarding these adjustments Part number MA00003 Issue No 2 March 2013 28 of 56 5 5 Doffing removing the i limb skin natural Cover Position the thumb to approximately 15mm 0 6 inches away from the index finger Rotate the thumb so it is positioned away from the palm lateral position Slide the covering gently up and over the thumb up to the base of the fingers Ensure the fingertips of the glove are loose Remove the covering entirely by gently drawing the fingers of the cover
22. elow o Visit us on the web Review offline patient information oO Search for i limb ultra Searching BioSim is searching for i imb ultra devices P0647 n The progress bar will stop when the search is complete Select the desired i 4imb ultra from the list on the right and then press the Next button to connect 31 of 56 6 3 Navigating biosim The You re now connected screen will now be showing with seven options as illustrated this is the homepage and can be You re now connected accessed at any time from subsequent pages oie ae Choose from one of the following options Myo testing icon provides a quick and easy myo site test along with a more detailed analysis screen Myo testing Control strategy details the choice and information around the range of control options as well the logging of user information Control strategy Features allows the set up of the i limb ultra by linking triggers with grip patterns and gestures Features Training provides access to the training suite and a selection of games to improve overall hand control Training Hand health check icon provides a quick and easy diagnostic check of the hand Hand health check Usage icon provides access to a tally of individual movements with additional analysis Exit icon draws the session to a close exiting the program Exit Part number MA00003 Issue No 2 March 2013 32 of 56
23. es 3 following the same line rising nicely above the 1 on the graph 25 15 0 5 EET TE E E Part number MA00003 Issue No 2 March 2013 40 of 56 The graphs shows an ineffective co contraction attempt The open and closed impulses are not timed to show alignment and so are not recognized as a co contraction The graph shows an ineffective co contraction attempt Although the open and closed impulses are well alligned the red open signal is not of sufficient strength above 1 on the graph to be recognized as a co contraction Part number MA00003 Issue No 2 March 2013 41 of 56 L i 4 Al fh EEE T i E E y F G NE Part number MA00003 Issue No 2 March 2013 Double impulse two uninterrupted open signals the impulse duration is the period of time that the impulse is above the threshold It is preset at 300ms and can be customized from 30 to 3 000ms The impulse period or period within which the impulse must occur to be recognized is preset at 1 000ms and can be customized from 500 to 3 000ms The graph shows an optimal double impulse Both impulses are of sufficient strength to break the threshold the first impulse drops below the threshold to allow recognition of the second impluse Both impulses are activated within the preset impulse period The graph shows a failed double impulse attempt The double open signals are strong and within the preset impulse period however
24. gnals however the blue closing signal is flat lining at the top of the raph proportional control of the hand is diminished Reduce the gain setting on closing input R Soi i E et D AEA awh ao n amp Graph showing low signal strength Encourage patient to increase signal strength increase electrode gain if the patient is unable Poor signal separation with both signals being activated together 7 Select first over control strategy to encourage the patient to activite one muscle group at a time Ensure commands are clear O O and the patient understands what is required and return to basic i Since myo site training Pall i I r WANIEN hi M fle ho N m Ini n ki j j 1 l H i j fi i Wi IN n fl i Ni J j 4 WA al LOATA Bi f L i l i T f da i he n l iaf f Lc r ill i Ph i i 7 j l i Excessive signal activity with both signals together 3 Consider looking for alternative myo sites if the current myo 25 ee sites are the best option then select a first over control strategy MURI ae encourage the patient to relax signals and make a definite open 2 and closed actions with relaxation of the opposing muscles m A l i TIC ty E Alba Ta PALA ATERN Mar A ji 0 Part number MA00003 Issue No 2 March 2013 35 of 56 In the top right hand of the opening control screen the Device information box wi
25. he light display is as follows For customers residing in parts of Europe and the United States the charger pictured to the right fig 4 is used The light display is either Red rapid charge Green fully charged Charging time from full discharge is approximately 1 300 mAh battery 90 minutes 2 000 mAh battery 180 minutes On Off Switch For customers residing in the UK Australia and South Africa the charger illustrated to the right fig 5 is used The light display is as follows Solid Amber on standby Figure 4 Slow flashing amber pre charge mode Rapid flashing amber Error Slow flashing green maintenance charge Rapid flashing green rapid charge Solid green fully charged Charging time from full discharge is approximately 1 300 mAh battery 180 minutes 2 000 mAh battery 180 minutes Insert the charger lead connector into the charge port A click should be heard on connection Figure 5 Insert the charger into the power outlet To remove the charger lead connector grip the connector and pull directly away from the port Consult warnings and precautions in section 7 3 DO NOT PULL THE CABLE TO REMOVE THE LEAD To ensure the i limb ultra is continually functional charge at the end of each day Switch the hand OFF to preserve battery power when not in use Only use supplied Touch Bionics charger to charge battery N Replace the battery annually for optimal performance gt e e D
26. heck the electrode cable is not damaged Check the battery cable is not damaged Check that the i limb ultra is connected correctly to the wrist Contact Touch Bionics Electrode settings may be too low Ensure the battery has good charge Ensure the electrodes maintain good contact Check electrode placement and wiring Contact Touch Bionics 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 Refer to section 6 3 2 for proper control strategy Replace the battery Contact Touch Bionics 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 Touch Bionics Check box in biosim or switch the electrode connections on the lamination ring Check the battery is connected 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 49 of 56 7 3 Warnings and Precautions i limb ultra 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 m
27. i limb ultra with a single myo site when a second site is not possible Control strategy can only Control strategy be changed through biosim further control strategies for both dual and single site control are possible Dual site Differential the stronger of the two signals determines whether the hand opens or closes As one signal becomes stronger than the other the hand direction changes This strategy allows for rapid switching between hand operations there is no requirement to fully relax the signals to change direction Dual site First Over the presence of a signal above the threshold level before its opposing signal will result in the hand moving in the direction of the that signal While the first over signal remains above the threshold it will have dominance over the opposing signal regardless of which is strongest Signal dominance only changes once both signals drop below the threshold level This is a useful training strategy to develop signal separation Single site Voluntary Close the presence of a signal above the pre set threshold level results in the hand closing Any signal below the threshold or removal of the signal will result in the hand opening The graph shows good separation of inputs with opposing channel remaining below the threshold level aa Dual site Differential Single Site voluntary closing strategy Device name U02564 The stangh ofthe input signal demrmines hand opstien
28. k will not stain unwashed blue jeans and fabrics bleach Please consult the Cover Care Guide supplied for a complete chronic exposure to cigar and cigarette smoke carbon paper Overview of cover wear and care guidelines and carbonless carbon paper other products may also stain your cover The list provides examples of products that can damage the cover when using new products for the first time use with caution If the cover is stained washing quickly with warm water and plain soap and then cleaning with alcohol is most likely to remove the stain Failure to keep the cover clean as instructed above will invalidate the warranty on the cover If cleaning does not remove the stain then contact Touch Bionics for an evaluation and repair Refer to the back page for contact information Part number MA00003 Issue No 2 March 2013 30 of 56 Part number MA00003 Issue No 2 March 2013 6 1 biosim Overview The i limb ultra is fitted with a Bluetooth receiver enabling it to work with a sophisticated software package known as biosim biosim pro is the clinician s version of biosim and biosim i is the version designed for patient users Using biosim it is possible to make radical changes to the functionality of the hand biosim i is the patient user version of biosim and contains a simplified version with access to training and games features along with some basic changes to settings The biosim software working through the
29. ll indicate the i limb ultra serial number An option exists to swap input channels if the prosthesis has been wired incorrectly in addition an option is provided for adding a wrist rotator and to enter battery type The administrative tab allows for the addition of personal information the Patient Summary highlights user name and identifier code The session management allows for the saving of the last training session and review of previous sessions The Edit tab will lead to the Patient Wizard allowing for more detailed personal information Part number MA00003 Issue No 2 March 2013 Device information D a a Device name Battery type 1300 mAh 7 amp Z O Swap input channels z i O Using wrist rotator Cor ontraction Input channel filters B Enable signal filter on open channel 1 C Enable signal filter on close channel 2 Explain this Patient summary Last name or First name t No photo supplied o 3 ldentitifer U02264 ci z ia Session management Current session name not saved bc RI Reset device to factory defaults Update esting patent QP Patient wizard General information Update existing patient m a The pavent identifier is the Ss Prefix First name Midde name Last name Suffix Full mailing address 7 Gender Male Female Clinical information Amputation sde Left Right Bisterai oad Remove Number of digits remaining on left side a Existing carriers Pre
30. ltra is an externally powered multi articulating prosthetic hand which offers a range of features beyond the functions of the traditional prosthetic hand Individually motorized digits stall detection and the unique biosim software used to control the i limb ultra result in 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 ultra offers compliant grip through individually powered digits with stall out ability A manually rotating thumb in conjunction with a pulsing enhanced grip vari grip a slip preventing feature anti drop safety feature auto grasp and the wide range of automated grip patterns lead to broad functionality 1 2 Prosthesis Overview The i limb ultra is available in either black or neutral colors as well as small or medium sizes see technical specifications in section 9 1 for actual measurements The hand serial number is positioned proximal to the base of the thumb on the connection plate The serial number should start with a U and be followed by four numbers also highlighted in biosim see section 6 Part number MA00003 Issue No 2 March 2013 Part number MA00003 Issue No 2 March 2013 Motorized Digit Knuckle Palmar Fairing Manual Thumb Rotator On Off Switch
31. motor vehicle safely if required by local regulations contacting your insurance provider and advise them that you will be using the i limb device to drive a motor vehicle ensuring that the device has a fully charged battery Please note that the i limb device will emit a low battery signal which will alert you if the battery requires to be charged switching off the i limb device This is due to the possibility of involuntary muscle signals being generated and moving the thumb into the lateral position to allow the i limb to be removed from the steering wheel without opening the hand It is entirely the patient s responsibility to seek confirmation 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 Part number MA00003 Issue No 2 March 2013 51 of 56 8 1 User Details Provision of the following information will enable easy identification of your prosthesis should it be returned to customer service Please forward to Touch Bionics as per the contact information on the back page of this manual User Name Fitting Date Hand Purchase Date Hand Serial Number Prosthetist Name amp Contact Information Therapist Name amp Contact Information It is recommende
32. oad Oakbank Park Way Livingston EH53 OTH UK Mansfield MA 02048 USA Tel Customer Service 44 0 1506 445 415 Tel 1 855 MY iLIMB 694 5462 Tel General Enquiries 44 0 1506 438 556 www touchbionics com www touchbionics com Part number MA00003 Issue No 2 March 2013 55 of 56 9 4 Warranty Limited Warranty for i limb ultra Touch Bionics warrants that the i limb ultra will conform to its specifications and be free of defects in material and or workmanship for twelve 12 to sixty 60 months depending on package purchased from the date of Touch Bionics invoice for the i limb ultra This Limited Warranty applies only to an i limb ultra provided by Touch Bionics or an affiliate authorized by Touch Bionics to provide the i limb ultra This Limited Warranty applies to all components including but not limited to fixtures 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 ultra as its option If required replacements will be new products The wearer shall report any defect claim to Touch Bionics directly or to the facility that provided the i limb ultra immediately upon discovering the defect and in any event within the warranty period The defective i limb ultra must be returned to Touch Bionics or any other Touch Bionics authorized representative To find the nearest lo
33. onal Features Toward the bottom right of the screen the additional Global Options box can be used to give access to Vari grip pulsing Natural Hand and Auto grasp modes i precision pinch opened Midde ring and itte fingers remain fully opened and switch off Both index finger and thumb wil move to provide grip Available tnggers Click for example G GG Digit timing Van gnp pulsing OF On Natural hand mode Off On Auto gasp of On Vari grip pulsing this mode provides additional grip force S with subsequent activation of the closed signal The default Tor Pulse mode delay ms 500 The pulsing delay is the amount of setting for activation is 500ms 0 5 seconds which can time in milliseconds that the user be customised between 250 0 25 seconds to 3 000ms 3 must maintain their closing signal seconds beyond full stall of the digits before the pulsing action begins Cancel Part number MA00003 Issue No 2 March 2013 38 of 56 Natural Hand this feature returns each digit to a position 2 i se the sliders to define how long the digits will run from which can be preset by the user The default setting for tums sexon ms 3 Bic haar open OAR win ie toil guess barter i R Open Clos hand position activation is 30 seconds this can be customized between 2 i P A Bach cosnesis 6 Shghily different bul you carn usa the index Fe ms nia Stee ane and 60
34. opean or local regulations Only use the appropriate Touch Bionics charger to charge Touch Bionics batteries If the battery has visibly ballooned or swelled discontinue the charging process immediately disconnect the battery remove to a safe area leave and observe for 15 minutes replace the battery do not re use dispose of any leaking batteries in an appropriate manner Failure to comply with the above guidelines will invalidate the warranty contact Touch Bionics as follows Part number MA00003 Issue No 2 March 2013 50 of 56 Driving of Motor Vehicles The i limb device has the functional capability to assist a patient with driving a motor vehicle however due to factors including the differences in world wide driving regulations and the variations in the level of ability between patients Touch Bionics is unable to provide definitive 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 modified 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
35. oth muscles Do not be concerned with relaxing after the contraction Successful 0 of 1 times Actwe feature Normal Actwe tngger Not active Part number MA00003 Issue No 2 March 2013 45 of 56 Hold Open focuses on generating a strong open muscle signal K and maintaining it at a high level for several seconds Mastering this exercise will enable use of the hold open trigger Successful 2 of 2 times Acte feature Normal Active tngger Not actwe biosim by touch bionies CEEE Speed and Separation focuses on generating quick strong K muscle signals whilst isolating the opposing muscle This exercise lays the foundation for impulse control Successful 0 of 13 times Acte feature Normal Acte tngger Not actwe aj 6 3 5 Hand Health Check Hand Health Check screen provides a quick and easy check of the hand Simply click on the Health Check icon and the health check will begin Hand health check Run hand heath check Senal number 026s Femara version 210 12 The i limb ultra will then go through a series of movements as each digit is checked the process will run for approximately 8 seconds and provide basic feedback on completion of each check 8 0 oo no S Checking power to the hand Passed Run hand heakh check G Checking battery life Passed Serial number URSS G Checking digt function Passed Firmae wersion 21012 Part number MA00003 Issue No 2
36. oving 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 flames 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 qualified Touch Bionics technicians and technical partners Do not use with a damaged cover Damaged covers must be replaced or repaired by a qualified Touch Bionics technician or technical partner Only approved Touch Bionics accessories and tooling may be used with the i limb ultra Failure to comply with the above guidelines will invalidate the warranty If utilizing an i limb ultra mutli flex wrist the hand should be locked if carrying an object If you experience technical problems with the i limb ultra 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 US Eur
37. rame section above the dummy battery Use the Velcro strip supplied to attach the battery to the inside of the socket interface If the area between the residual limb and the lamination ring is insufficient 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 residual limb is a wrist or elbow disarticulation the battery is too large for the space available in the socket interface frame Wiring Schematic for 1300mAh Low Profile Battery with Switch Block Cutting or modifying the battery wires in any way will invalidate the warranty Do not bend or shape the battery in any way Ensure the battery is not subject to continued pressure once fitted Part number MA00003 Issue No 2 March 2013 12 of 56 2 5mm D C Socket Co axial Bush Rotator Low Profile Battery Cells Placed Side by Side SA000219B Switch Block Power Cable Co axial Bush Rotator SA069031A Switch Block SA069080A Switch Block with flying Leads Low Profile Battery Cells Placed Side by Side 2 7 Battery Charging Fully charge the battery prior to fabrication This may take up to 2 hours The i limb ultra should only be charged using the Touch Bionics charger supplied During charging turn the hand to the OFF position and remove the prosthesis from the residual limb T
38. ric shock 1 2 3 Degree of protection against ingress of water IEC 60529 2001 IP40 1 2 4 Not suitable for use in the presence of flammable anesthetic mixture with air or with oxygen or nitrous oxide 1 3 EMI EMC 1 3 1 Compliance against standard EN 60601 1 2 2007 1 4 Radio Spectrum Matters ERM Bluetooth 1 4 1 Compliance against standard EN 301 489 1 V1 8 1 1 5 EN 301 489 3 Clause 7 1 1 5 1 EN55022 2006 1 6 Radiation emissions Enclosure 1 6 1 EN 301 489 1 Clause 8 2 Pass 30MHz to 6 000MHz 1 7 Zones of Use 1 7 1 Not recommended in zones 0 1 20 and 21 N B See www touchbionics com for further information on EMC testing carried out on products within this manual Part number MA00003 Issue No 2 March 2013 oye mole Refer to operating instructions Class Il equipment provides double Isolation to protect against electric shock Degree of protection IP40 Protection against penetration by solid particles with diameters larger than 1 mm No special protection against penetration by water Batch Lot ID Number For i limb ultra devices Each device has a guaranteed unique id number example 0001 2012 The 5 digit alpha numeric number is the unique serial number for the device and the then the year of manufacture of the device is added WEEE Compliance Catalogue number Manufacturer Keep Dry 1 Customer Service Contact Information Touch Bionics Unit 3 Ashwood Court Touch Bionics 35 Hampden R
39. rranty 2 6 Battery Installation The battery is designed to be mounted inside the socket inter face 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 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 Easier access to the on off switch may be possible by installing a switch block this allows the on off switch to be positioned in a more proximal position on the forearm The use of a switch block also provides an additional accessory switch for temporarily disabling an electric wrist rotator or other electrical device when needed Part number MA00003 Issue No 2 March 2013 11 of 56 When the switch block is used in combination with a wrist rotator a ue Wiring Schematic for 1300mAh Low Profile the switch block will simultaneously turn off the i limb ultra and Battery with D C Socket the electronic wrist rotator Do not apply excessive force to the charger socket interface during assembly A minimum of 2mm of free space should be provided surrounding the charger port or switch block A flat surface is needed to secure the charger port or switch block to the socket interface frame This may require additional shaping of the f
40. rt training exercises aimed at developing control of the i limb ultra The opening screen highlights the series of exercises which can be selected individually and in any order Both open and closed signals can be practiced AN omun sesse EEEN omun 00000 indication of difficulty is provided by the 5 point mm ee scale on each module seg Start exercise Training Difficulty 00 0 0o Start exercise Difficulty 00 eee Start exercise Difficuly eeeee Start exerdse Difficulty eeee Start exercise Part number MA00003 Issue No 2 March 2013 44 of 56 Strength Only focuses on generating a smooth strong muscle signal without concern for the opposing muscle signal This A Successful 2 of 4 times exercise helps to strengthen the muscles and improve endurance x Active fame Normal Active Ingger Not actve Speed Only focuses on generating quick strong muscle signals Do not be concerned about the opposing muscle in this _ ee exercise Active feature Normal Active tngger Not active p Strength and Separation focuses on generating a smooth strong muscle signal while isolating the opposing muscle This exercise helps with separation of signals Successful 2 of 2 times x Open Close Acte feature Normal Acte tngger Not actwe biosim by touch bionics CEEE Co contraction focuses on generating quick strong U contractions with b
41. s users initially set one or two triggers while familiarity and control is gained Part number MA00003 Issue No 2 March 2013 43 of 56 By left clicking any of the features on the features page the available triggers and example sections will also appear In order to preview a feature simply highlight the feature and click on example to the right of the screen The section will then enlarge and provide a demonstration of the feature The hand image can be rotated to improve visualisation by holding the left mouse key and moving the curser in the direction of the intended rotation Linking Triggers with Features In order to link a trigger with a feature simply click on to the biosim by touch bionics desired feature the feature will now be highlighted in Touch l Bionics lime green Select and click the desired trigger which has 0995 om one ofthe fotowing atures Standard precision pinch opened been selected to link with the highlighted feature Both feature KI Y Y EEE BEEE and trigger should now be highlighted and the descriptive label wy O roise woos chek tr mangl will now appear The illustration indicates the Standard Precision T Pinch Open feature linked to the Hold Open trigger K 9 AJ A Die gt gt N ai Hold open Settings GY GOR Ww db Natural hand mode Off On Auto grasp Off On Hand health check 6 3 4 Training The training suite contains a variety of sho
42. seconds x Rexion ms baie Choe BUllons below to get you started icicle lean ima 7 Open Close Fag flexion ris pan Close ial ikrrils Sart acd Load defauits Litthe flexion imat Open Close i limb skin natural Load defauts Timeout aeta 30 Cancel Auto grasp this feature enables the user to counter a false S nn n open signal during grasping If a false open signal is identified the grip of the hand is automatically tightened Activation is preset to inadvertent open signals of less than 100ms High level activation Choose high level to ensure that the hand has detected a full stop grasp before activating auto grasp detection Low level activation 0 1 second in duration The option of High level activation logic ensures that the device has detected a full stop grasp before Choose low level to activate auto grasp activating auto grasp Low level activation creates auto grasp detection logic upon any closing motion upon any closed signal to the hand of the hand If using a i limb skin the digits will move slower so the timing will have to be adjusted In addition to customization of timing each of the modes can be completely turned off Triggers A trigger is the signal sensed by the electrode Four potential triggers are available Hold open Co contraction Double impulse and Triple impulse Hold open a prolonged open signal this is preset to 2 000ms 2 seconds and can be customi
43. ss the Next gt button when you are ready to continue Press the Next gt button when you are ready to continue Next gt Next gt Cancel 36 of 56 6 3 3 Features Click on the features icon to enter the features suite The feature page provides access to all available features and associated changes Features are the actual movements of the hand and triggers are the muscle action used to Features create the movements Global options Vari grip pulsing Off oOn aA Natural hand mode Off On Auto grasp Off On A Features Catalogue Precision Pinch Grip Options Standard Precision Pinch Closed middle ring and little finger automatically close and switch off Index finger and l j thumb provide grip Cy Thumb Precision Pinch Opened a_i Thumb Precision Pinch Closed Standard Precision Pinch Opened middle ring and little finger remain fully opened and switch off Index finger and thumb provide grip middle ring and little finger automatically close and switch off Thumb automatically middle ring and little finger remain fully opened and switch off Thumb automatically moves to a partially closed position Index moves to a partially closed position Index finger will move to provide grip against a finger will move to provide grip against a fixed thumb fixed thumb Tripod Grip Options Standard 3 Jaw Chuck Tripod Opened Standard 3 Jaw Chuck Tripod Closed ring and lit
44. t recommended to be worn with Touch Bionics covers A silk or smooth fabric lined glove will be easily put on and Cleaning Precautions taken off the hand Gloves should not have bleeding dyes when Oils and oily substances alone may not damage the cover damp or wet However oily substances attract and create an adherence of dirt grime and other chemicals which can lead to damage of General Precautions the cover if it is not washed and cleaned regularly as described above Many hair and body products contain oil and should only The i limb ultra must be used with an approved Touch Bionics be used when the prosthesis is not being worn Exposure to oils cover and oily substances may make the prosthesis look shiny Do not use oil control cleansers to manage the shine these are abrasive and will give the cover a tarnished appearance e Always use the correct size cover and the correct orientation left or right Never put more than one cover on the i limb ultra Body perspiration contains oils which can accumulate and damage the prosthesis if not removed by appropriate cleaning Ensure the cover is fitted properly Always use IPA provided as directed Staining Although the cover is made of a durable material it is possible The i limb ultra warranty may be invalid if used outside of the for it to become stained Some substances to avoid include blue recommendations Woolite permanent markers some pens and inks newspaper in
45. the ability to don doff the prosthesis and that the posi tion 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 Part number MA00003 Issue No 2 March 2013 2 3 Charge Port Placement Assembly It is important to provide sufficient space for the charge port between the inner and outer sockets The charge port should be positioned so that it is unaffected by forces running through the socket to prevent damage Create a drill hole of 8 0mm through the inner surface of the prosthetic frame Ensure a flat 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 Engag
46. tle finger move to terminal close Thumb index and middle fingers move to provide grip ring and little finger remain fully opened and switch off Thumb index and middle fingers move to provide grip Thumb 3 Jaw Chuck Tripod Opened Thumb 3 Jaw Chuck Tripod Closed ring and little finger move to terminal close Thumb automatically moves to a partially closed position Index and middle fingers move to provide grip against a fixed thumb ring and little finger remain fully opened and switch off Thumb automatically moves to a partially closed position Index and middle fingers move to provide grip against a fixed thumb Part number MA00003 Issue No 2 March 2013 37 of 56 Additional Grip and Gesture Options Thumb Park Continuous Thumb Park Quick all four fingers remain open and switch off only the thumb will move all four fingers remain open and switch off for 1 5 seconds the thumb will close and then automatically return to an open position Lateral Grip Index Point all four fingers fully close and switch off Only thumb will move thumb little ring and middle fingers close and switch off Only the index finger will move Custom Gesture Custom Grip all fingers automatically move to a user defined fully opened or fully closed position and switch off all fingers automatically move to a user defined position The user can choose to keep certain digits active and switch others off Additi
47. ulation off the base of the i limb ultra Separate the i limb ultra from the Wrist Disarticulation drawing the power cable through the Wrist Disarticulation For guidance on fabrication consult section 2 2 Socket Fabrication 3 4 Flex Wrist The Flex Wrist is connected directly to a QWD and offers three wrist positions 30 dorsiflexion 0 neutral and 30 palmar flexion The control switch is positioned on the palmar surface of the wrist and is manually operated See i limb ultra flex data sheet for more information on the Touch Bionics website www touchbionics com downloads document library Control Switch Part number MA00003 Issue No 2 March 2013 18 of 56 3 5 Multi flex Wrist The Multi flex Wrist is connected directly to a QWD and can be used in either passive or locked mode Passive mode allows spring loaded flexion extension and lateral deviation Locked positions options are 30 dorsiflexion 0 neutral and 30 palmar flexion The control switch for locking is located on the medial lateral portion of the wrist and is covered by the flexible wrist sleeve See i limb ultra multi flex data sheet for more information on the Touch Bionics website www touchbionics com down loads document library Note when unlocking you must disengage the spring by putting pressure against the hand in the direction the hand was locked Control Switch Part number MA00003 Issue No 2 March 2013 19
48. umb park contirucus Excessive signal activity counts Refresh counts Reset counts Input channel 2 tme 1 gt Input 1 extensor Input 2 fiexor Save counts View count history View feature graph eecoeeaeeaeawaee ae oo eeee0ecees9dso Part number MA00003 Issue No 2 March 2013 47 of 56 7 1 Storage and Maintenance Always turn off the hand when not in use Aim to charge the battery each day after use Replace the battery every 12 months Part number MA00003 Issue No 2 March 2013 48 of 56 7 2 Troubleshooting Problem Hand does not operate One digit does not operate Hand stops halfway during an action User complains that the hand is difficult 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 Battery is not working Part number MA00003 Issue No 2 March 2013 Action 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 Check if the digit operates correctly using the Hand Health Check in biosim Exchange digit with an alternative working digit from same or different i limb ultra and re check If replaced digit works contact Touch Bionics Electrode settings may need to be adjusted C
49. uments required T10 Screwdriver provided by Touch Bionics Support the i limb ultra in the palm of the hand Fully abduct the rotating thumb Part number MA00003 Issue No 2 March 2013 21 of 56 Disconnect the Palm Fairing using the T10 screwdriver to loosen the palmar T10 screw Gently move the Palm Fairing to the ulnar side to allow access to the exposed T10 screw at the base of the thumb Using the T10 Screwdriver access the screw from the medial to lateral direction to loosen The thumb is now easily removed from the knuckle block Part number MA00003 Issue No 2 March 2013 22 of 56 Position the replacement thumb in the knuckle block and follow the above steps in the 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 anti vibration 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 PL177001 for use with all T10 screws in the i limb ultra Part number MA00003 Issue No 2 March 2013 23 of 56 Part number MA00003 Issue No 2 March 2013 5 1 Co
50. ures 24 of 56 5 2 Donning putting on the i limb skin active Cover Position the thumb of the i limb ultra approximately 15mm 0 6 inches from the i limb ultra index finger Align the i limb skin active cover with the digits and pull the cover down over the digits Gently pull up and over the thumb taking care not to cause any undue downward pressure on the thumb Pull the i limb skin active cover over the hand to the wrist Individually maneuver the fingers of the i limb skin active cover over the fingers until they are fully aligned Part number MA00003 Issue No 2 March 2013 25 of 56 5 3 Doffing removing the i limb skin active Cover Gently maneuver the i limb skin active cover from the wrist up and over the base of the thumb taking care not to cause any undue downward pressure on the thumb Grip the fingertips of the i limb skin active cover and gently maneuver it upwards over and off the i limb ultra 5 4 Donning putting on the i limb skin natural Cover Spray the Silicone outside of the covering generously with the IPA Isopropyl Alcohol lubricant cleaner supplied Part number MA00003 Issue No 2 March 2013 26 of 56 Roll the covering back on itself from wrist to fingers until the opening for the fingers is showing Push the bat provided into each of the fingers and thumb in turn to straighten This will help the covering slide onto the extend
51. ver Options The cover of the i limb ultra is very important The i limb ultra should not be used without an approved cover that is well maintained A number of options are available to cover the hand All covers require regular checks for wear and tear and some require routine maintenance Covers will need occasional replacement due to wear and tear The i limb skin active cover is designed for the i limb ultra 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 The i limb skin natural cover is designed to be close to natural human anatomy A color swatch is available to select the closest color match between the user s natural skin color and the color of your i limb skin natural cover There are ten color options for the i limb skin natural cover the glove may not be an exact match but will be very close Skin color may change depending on exposure to the sun changes in diet environmental temperature or movement Because of this patients may require different glove colors throughout the year Color swatches are available on request For individuals who desire the most realistic covering option pos sible i limb skin match is available which is a fully customized silicone covering that is hand painted to match the individual patient skin tones and feat
52. zed from 2 000 to 5 000ms Hold open time ms 2000 The hold open time is the amount of time in milliseconds that the user must maintain their opening signal beyond full stall of the digits before the hold open trigger is activated Cancel The graphs show a good hold open trigger the signal strength 3 is well above 1 0V and the signal duration is around 3 seconds 2 5 TT ll 09090905 Threshold level 1 5 wa Ls 0 5 po fi 2 E Part number MA00003 Issue No 2 March 2013 39 of 56 Co contraction is the creation of simultaneous open and ma closed signals Co contraction may be customized if a ave O Pa tert nen peen cn Active trigger Double impulse patient has difficulty with activation with the default time This is done by going to myo testing and entering co contraction in the training mode drop down box The Begin Calibrating icon will then appear on starting calibration 4 successful attempts must be made at a co contraction for biosim to create the parameter settings O O BA DO 2 P amp Display 30seconds Training mode Co contract Analog gauges Resi tme graph Trout channel setengs changed success ty biosim by touch bionics urre Active feature Normal Bball r Not actrve P E Display 30 seconds Training mode Co contract The graphs show an optimal co contraction with both impuls
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