technical information
Contents
1. Save The hand can be configured and the settings sent to the hand without saving if you want to give them a try If you wan to retain these settings for further amendment or back up you need to click Save Before the data IS saved a patient identifier must be entered There Is a description fleld for recording specific Information as necessary History Clicking History opens a list of Saved configurations By entering a patient identifier and clicking on the Find button you can filter the records to only snow the relevent records This feature enables the recovery of previous settings for re sending to the nand or providing a base to work from Send to Hand With the radio dongle inserted and configured and the radio activated on the hand It starts transmitting a stream of signals which can be identified by the rapid flashing of the LED on the dongle Clicking Send to Hand starts the transmission of the current configuration to the hand On completion the message panel on the right will show success or in failure of the process um bionic mom E et ET e Hamas in pum BiT np T usum ss 1 la repr 3 DI T ee a tet Ame ee ET e y LE eme lies es a DELLE tama Pros lan ur a i fuam jo oam C 7 Lar j Ba Car Jn r e pa e Psi mud dide Pasar Came Con CRE S i i 1 EN CES i ia Qu erba _ E2. ee A Leper 55a c dj Cee pes a qna chen Tu E Lue irp Fu By default the configuration screen opens with dual site control strategy You can change to single site by point amp click on the single site radio button under Control Strategy e Grip Selection Grips can be selected and ordered as desired by the user by a simple point and click in the relevant tables PTE CERES 3448 a CE CENE y Uu prem _ bionic lc te me LJ arn E a ge Opposed Primary This enables selection of the initial two arp patterns avallaole wrth the thumb in the opposed position The default grip is available immediately the user can switch to the alternate grip by applying the appropriate change signal e g in mode 4 an OPEN OPEN signal wil Switch between the default and alternate grip patterns Non opposed Primary Allows selection of the grip patterns as described above but with the thumb in the non opposed position Opposed Secondary This enables selection of a further two grip patterns with the thumb in the opposed position These anos are activated by pressing the programme switch on the back of the hand As with the primary grip patterns the user can switch between the default and tne alternate grip by applying the appropriate change signal he user can retum to the primary grip pattems by pressing the programme switch Non opposed Secondary Alows selection of the gro patterns as described for Op
3. Vi bionic technical Information Contents Gal pice Clb OO ET EI 04 07 1 In the Box 2 Principal Dimensions 3 Specifications AOS AO PT UTEM 09 19 2 1 Factory Settings 2 2 Programme Switch 2 8 Thumb Adjustment 2 4 Opposed Grips 2 5 Non opposed Grips 2 6 Further Grips and Hand Positions US O ee en TUTTI 21 25 3 1 How to fit a bebionic Glove 3 2 Removing a bebionic Glove 3 9 Care Instructions for bebionic Glove ZONE ACID GE I rere terete lies 21 35 4 1 Wrst Options 4 2 Battery Options 4 3 Power Information 4 4 System Connections 4 5 System Compatibility ade cr atada 3 49 9 1 Introduction 5 2 Installation 3 Start up 4 Language Selection O Ol Gi 5 Radio Frequency Module Configuration O 6 Operating Modes 5 7 Hand Configuration 5 8 Grp Selection 5 9 Advanced 6 0 Additional Information Warranty Repairs and REUS wire 01 63 6 1 Gaiter Removal 6 2 Galter Refitting 6 3 Clevis Link Replacement 6 4 Quality Assurance 6 5 Warranty 6 6 Returns 04 1 0 Introduction This document contains important Information for tne correct use and set up of the oeolonico nana Please note some of the Images may ciffer as this document applies to both the medium and large size of hands Head this document throughly before fitting a beboionica Nand A bebionic system ls completed by adding trom a selection of compatibl
4. 12K44 ErgoArm Hybrid plus BE330 Boston Elbow Digital Wrist Otto Bock 10817 13E205 Wrist Rotator and MyoRotronic Program 1 2 Electrodes Fast Rise bebionic Mode 4 2 Electrodes Safety Co bebionic Mode 4 Contraction 1 Electrode or 1 Linear mM Program 5 RH bebionic Mode O 4 Mode 3 Program 3 Please note Devices or components not listed above are not recommended OO 9 0 operating Instructions Debalances has been designed to give you optimum control over tne new bebionica hand It features many new tools which will helo you and your oatients optimise and customise the tunction of the nand Language selection electrode configuration with a simulation preview and simplied menu systems are al Included in bebalances Note Installation disc Is affixed to the inside back cover Caution Please DO NOT programme or control a bebionic system with Unapproved alternative software or hardware systems Doing so will void the warranty Of OO 5 1 Introduction Out of the box the bebionic hand is pre configured with two site proportional myoelectric control Mode 4 where an OPEN OPEN signal is used to change grip patterns Ihis mode has been chosen to provide a Standard solution that works well for the majority of users who demonstrate two well controlled muscle signals However bebalances is particularly useful it muscles produce limited or dificult to control signals as is oft
5. up to 4 grip pattems Please note Where more than one grip pattern is available the practitioner can select the default and alternative grips for both the orimary and secondary grip pattems using bebalance programming software Pressing the programme switch on the back of the hand allows the user to alternate between the primary and secondary set of grip pattems The hand wil be delivered pre set to Mode 4 with default values set to provide an operational hand straight out of the box Configuration via bebalance may therefore not be essential pre fitting A 42 Oe Hand Configuration Introduction For most patients the factory settings on the bebonic nand wil be adequate However for experienced oracttioners bebalance software can be used to customise each hand to each indmdual through the bebionic menu option Configuration essentially changes the way the bebionic hana operates These changes are downloaded trom the computer to the hand to allow the user to try them Successful alterations can be loaded and saved in the hands memory Details of individual iteration once saved are witn the patient s ID in the History file D Caution Only bebionic v2 and bebionic3 hands can be programmed using bebalance23 Hand Configuration Select bebionic on the main menu to open the configuration screen as shown below The No HF ound message may be replaced with RF Dongle Found E bionic
6. x 20 UNF Stud BBHMD FW 121mm 37mm 5500 bebionic3 Medium Hand with RSLSteeper Friction Wrist BBHMD EU 121mm 16mm 5679 bebionic3 Medium Hand with M12 Thread Stud t Build height comprises of thumb tip to base of hand measure followed by the build height for each wrist option The second number refers to the minimum allowance for the mating wrist unit Denotes side of hand i e insert L for a left hand or R for a right hand Maximum Power Grip Force 140 1N 140 1N TAO ARTS SS Maximum Key Grip Force 26 5N 26 5N D SRE ART Maximum Time to Open or Close Power Grip 1 0 Seconds 1 0 Seconds Ri RE TO Maximum Static Load Hook Grip 45Kg 45Kg Maximum Finger Tip Extension Load Of Deal I enle 2 0 DEDIONIC grips ne bebionics hand provides a number of grios allowing the user to nave a more complete device to assist them in their day to day life The hand nas two selectable thumb positions opposed amp non opposed Opposed is where the thumb is In opposition to the fingers on the hand allowing grips like pinch and power Non Opposed is where the thumb is parallel with the fingers of the nanc and allows gros like key and finger point Opposed Non opposed O9 Introduction 9 d Factory Settings The hand is supplied preset in Mode 4 his provides two input operation with proportional control of grip ana Speed Speed amp grip force are set to maximum To alternate betw
7. On opening the application the main screen shown above will appear Any greyed out options are currently not operational ne area highlighted in red identites the bebalance version number Dd malin oelection At the bottom of the entry screen there are hyperlinks avalable to select the appropriate language hose available are English French German Spanish ana Portuguese ore Radio Frequency RF Module Configuration Lr itm ne c bion bionic e l om a am maru B b e aj epe E TAS EU my Le P iksi el bebalance now has an auto detect feature for the radio You are advised to insert the RF dongle into a USB port of the computer before starting the application as it wil be detected on start up However if you forget just insert the dongle and either retum to the entry screen menu as highlighted above Or on the configuration screen click on the button marked Radio When tne radio dongle has been found the message box will show RF Dongle Found highlighted in green f not found the message box wil snow No HF Dongle Enabling RF Module on the bebionic Hand With the hand switched ON press and hold the programme switch on the back of the hand for approximately three seconds until the RF dongle begins to flash continually Note his function differs from the glove conning mode as to enable the RF Module the hand must be switched ON whereas in glo
8. exposure compliance This transmitter must not be co located or operating in conjunction with any other antenna or transmitter Changes or modifications not expressly approved by the party responsible for compliance could void the user s authority to operate the equipment The RSLSteeper bebionic Medium Hand Model RSL RP609 complies with Part 18 of the FCC Rules Section 18 212 The antenna s used for this transmitter must be installed to provide a separation distance of at least 20cm from all persons The End product must have a label stating Contains FCC ID PBBGC350616 place on it inline with FCC labelling regulations The FCC and IC information is located on the outside of the palm of each hand left and right underneath the gaitor 59 60 INDUSTRY CANADA STATEMENTS This device complies with Industry Canada licence exempt RSS standaral s Operation is subject to the following two conditions 1 this device may not cause interference and 2 this device must accept any interference including interference that may cause undesired operation of the device Under Industry Canada regulations this radio transmitter may only operate using an antenna of a type and maximum or lesser gain approved for the transmitter by Industry Canada To reduce potential radio interference to other users the antenna type and its gain should be so chosen that the equivalent isotropically radiated power e i r p is not more than that
9. standard is monitored by a programme of internal and external based audits All individual products are marked indicating that they comply with the requirements of the Medical Devices Directive 93 42 EEC MDD The mark may be applied on packaging accompanying literature or an enclosure rather than the product itself The bebionic hand and its associated components listed in this document are covered by test certificates for BS EN 60601 1 2 2007 Electromagnetic Compatibility for Electronic Hand EMC BS EN 60601 1 2006 Medical Electrical Essential requirements for Safety BS EN 60950 1 2006 Information Technology Equipment for Safety ETSI 300 440 2 V1 3 1 2009 03 Electromagnetic Compatibility for RF Module ETSI 301 489 3 V1 4 1 2002 08 Electromagnetic Compatibility for RF Module Additional internal and external test results and associated project documentation can be found in the Technical File RP609 TC Class Standards Vue 00 FCC Warning Statement This device complies with Part 15 of the FCC Rules Operation is subject to the following two conditions This device may not cause harmful interference and This device must accept any interference received including interference that may cause undesired operation This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment End users must follow the specific operating instructions for satisfying HF
10. used on the final product In these circumstances the OEM integrator will be responsible for re evaluating the end product including the transmitter and obtaining a separate Industry Canada authorization End Product Labeling The RSL RP609 Module is labeled with its own IC Certification Number If the IC Certification Number is not visible when the module is installed inside another device then the outside of the device into which the module is Installed must also display a label referring to the enclosed module In that case the final end product must be labeled in a visible area with the following Contains Transmitter Module IC RSL RP609 Or Contains IC RSL RP609 The OEM of the RSL RP609 Module must only use the approved antenna s listed above which have been certified with this module The OEM integrator has to be aware not to provide information to the end user regarding how to install or remove this RF module or change HF related parameters in the users manual of the end product The users manual for the end product must include the following information in a prominent location To comply with Industry Canada RF radiation exposure limits for general population the antenna s used for this transmitter must be installed such that a minimum separation distance of 20cm is maintained between the radiator antenna and all persons at all times and must not be co located or operating in conjunction with any other antenna o
11. 00S5 BBI 22005 LJ A 3 Power Information A WARNING system cables MUST NOT be cut while power is ON This will short the battery and will damage the system Any damage caused is considered to be outside of the bebionic warranty Power Cables A bebionic hand uses five actuators and therefore requires a higher current supply than single motor devices This can be accommodated safely using bebionic power cables Other power cable types may not be efficient or Safe However cables from other manufacturers may be adequate for signaling application Low Power Condition When the battery capacity approaches its lower limit the nana wil begin to slow With continuous use it will eventually stop If the hand stops in a closed position the user can apply a series of open signals to fully open the hand The nana will remain in an open position until the battery is recharged A WARNING The prosthesis MUST NOT be worn whilst the batteries are charging Battery switch Charging Module A ON OFF switch is integrated into the charge module The switch disconnects power completely and has 2 positions When the switch is positioned closest to the charge point power is OFF and the battery can be charged by connecting the lead from the bebionic charger When the switch is furthest away from the charge point power is switched ON Connecting the charger to the charge plug wil have no effect on the battery The ON OFF swi
12. 4 seconds Do not pull the fingers individually as this can Exit glove donning mode by pressing and holding damage the glove and hand the programme switch for 4 seconds the hana will automatically drive out of glove donning mode and will be active in tne default arip 24 DEDIONIC glove 3 3 Care instructions and information Care lake care when fitting and using silicone cosmetic gloves Iry to avoid contact with sharp or pointed objects The material used wil resist most staining media High Definition Nails Silicone gloves have nails painted by hand following the manufacturing process Bonding to the base material IS good We do not recommend the use of polystyrene nails attached with OCyano acrylic glue as attempts to remove the nails bonded with this adhesive will permanently damage the glove Cleaning General soling can be removed with soap and water Alter cleaning remove all traces of the cleaner and wipe the surface dry Most dyes will be fully removed by this orocess A liquid domestic fabric softener can be used in solution to reduce the tackiness of the surface For any other enauines please use the contact details supplied on the back cover of this document 29 of bionic 4 0 connections amp compatioliity A bebionic system is very versatile and allows a number of different wrist power and connectivity options Most options are detailed in tne folowing section of this docum
13. Epemi rae Read from Hand This feature enables the current hand configuration to be read from the hand and stored in the history file Following a read you are required to enter a patient identifier This enables retrieval of the specific patient configuration if desired Radio This enables connection of the radio module should you forget to install the dongle before running the application When the dongle is found the message box will RF Dongle Found highlighted in green ff not found the message box wil show No RF Dongle highlighted in red See section 8 1 for more information Quit This will close the configuration form and return to the main entry screen 45 46 Vertical Buttons Electrodes selecting Electrodes from tne vertical button menu opens a form shown second below This allows electrode signals to be monitored reviewed and adjusted mi fale a hk 6 a _ i T ET f oe a le zai lm HH Lim oues ird iamen ge i cum OE Ot Pema d om Fara fee Emr ren mier P ET LT bm Meer Li Er ho qe m ade mun maim Ln ammi CE m mmm eur Jm ll B Ln omar im Fm at FE Li iige on a CE o See c demi d i Per or Dep Has Jar fes LI 7 E Gael Tisi nit eo mm HE Tea lae deee4 eos A um Um Em um nds The slicers identified are for ind
14. N signal oignal Select amp Increase on Threshold This feature offers Open amp First protocols The default is Open which means that the hand will move in response to receipt of the larger signal if both exceed the electrode on threshold When the First option is selected the hana will open on receipt of the first signal to exceed the threshold and remains with this signal even if a larger opposing signal is received The exception to the First signal protocol is when an opposite signal exceeds the value of the controlling signal oy the amount set on the Minimum Dwell Threshold control If this happens the larger signal becomes the dominant signal If multiple signals are received to open and close the hand will continue to open unless the close signal exceeds the amount set on the Minimum Dwell Threshold control which is a value above the standard electrode level Dwell Threshold Min amp Max This feature is only used on Mode 2 The minimum control sets the level that the signal has to exceed within a time set by the maximum control Direction Change Timer This control is used in Mode 3 only It is used to set the additional time window when a second signal wil De accepted as an additional same direction movement ff set to zero hand movement will alternate with the next detected signal Improving people s lives RSLSTEEPER X 074 D JC 3 0 additional information warranty returns a
15. RZ roo az Connector Cable Please note Part B27804 is supplied with each battery pack and do not need to be ordered separately however part CBBHAT72 will need to be ordered separately for hands with short wrist friction wrist or threaded stem wrist options Components not to scale 33 34 4 5 system Compatibility The bebionic hand is potentially compatible with a number of different parts from other suppliers A common list ls shown on the page opposite Please adhere to the advice given below D Caution The bebionic system has not been exhaustively tested with all alternative electrodes wrists and control systems Any damage caused will be held to be outside of the design parameters of our system The statements above do not imply that RSLSteeper recommend or warrant these combinations We believe that on the basis of statements in the literature from these manufacturers that these combinations will work effectively but it is for the bebionic practitioner to test and warrant the combination These combinations may invalidate warranties given by other manufacturers The practitioner should confirm the Warranty position with these manufacturers Electrodes We recommend RSLSteeper E 50 or E 60 Both are avallable to purchase and are optimised for use with bebionic3 Inputs RSLSteeper E 50 amp E 60 MyoElectrode Otto Bock 13E125 13E2Z00 13E202 MYOBOCK electrode DC200B MyoElectrode Elbows Otto Bock
16. and anticlockwise to move the thumb away from the palm The effect wil not be observed whilst making the adjustment and can only be observed by resetting the hand i e switching the hand OFF and ON again Grios 2 4 Opposed Thumb is opposte to the fingers A SERIOUS WARNING NEVER use a bebionic hand with firearms Active Index Formeriy Trigger Grios 2 5 Non Opposed Thumb is inline with the palm Finger Point Grios 2 6 Further functions of the beoionica hand Precision Open Precision Closed Finger Adduction Grios 2 6 Further functions of the beoionica hand Ma Relaxed Hand Open Palm je af te bionic lt RSLSTEEPER E Improving people s lives s bionic 3 0 beblonic glove ne oebionic glove ls made trom D Caution a multi layered variable hardness slicone based material lined with tabnc mesh his construction resists soling wear anc puncture damage oebionic gloves provide nigh compliance with griboed objects hne fabric liner also allows the glove to slide over the joints during motion this reduces the amount of power need to drive the nand and increases battery lite he standard glove is supplied in 19 skin tones and also in a solid black Colour oebionic gloves provide an additional oamer to dirt dust and moisture Ingress to the hand Direct exposure to water or situations where cir ana dust are prevalent should be
17. avoided as these have the potential to interfere or damage the hands performance Thereis no alternative manufacturer of cosmetic gloves for the bebionic hand and wrist The use of other gloves may damage the hand and Will void the warranty PA 22 DEDIONIC glove 3 1 fitting the bebionic glove 1 Move the thumb Into the opposed position Switch the hand OFF by pressing down the programme switch on the back of the hand for approximately three seconds D Caution Do not use talcum powder or lubricant when fitting the glove e old up the base of the glove e Pul tne glove over the hana Caution Do not attempt to fit the glove unless the hand is in glove donning mode Press and hold tne programme switch for four The thumb will be in the position shown above seconds he hand will automatically drive into when the hand is in glove mode glove mode Ensure the fingers and thumb of of the hana Hold down the programme switch for four align correctly with the fingers and thumb of the seconds to exit glove donning mode and begin glove using the hand TS DEDIONIC glove 3 2 Removing the oebionic glove 1 Firsty oppose the thumb Then tum the hana Roll up the base of the glove and pull the whole OFF by holding down the programme switch for glove off from the back of the hand approximately three seconds Next put the hana into glove donning mode by holding down the programme switch for
18. certified person deliberate damage loads beyond those for which the product was designed or by modification or neglect You must state that you wish us to supply a replacement Glove Policy Cosmetic gloves are only replaceable under warranty where the failure is due to a manufacturing fault as we have no control over the environment in which they are used Please inspect the glove at first fitting to identify any faults so that we can provide a replacement where this is necessary To identify the hand serial number lift the gaiter on the back of the hand The serial number can be found underneath Please note Each bebionic hand is fitted with a passive Radio Frequenoy Identity Device to allow identification and trace during manufacture and in case of return to our bebionic service centres 6 6 Returns If bebionic components are to be returned for servicing please contact us at bebionic rsisteeper com stating the hand serial number We will issue a returns number and returns form that will need completeing in full so that your request can be dealt with promptly opare Parts Policy Some components of a bebionic system are replaceable by bebionic accredited practitioners For further advice on any repairs please contact your bebionic distributor or email enquiries steeperusa com For both parts and service please mention that the hand is a bebionic3 hand including details as the whether it is Large or Medium Left or Right and the da
19. default which will open and close in response to the electrode signals By applying an OPEN OPEN signal within a definable oeriod default 1sec the hand wil change to from a Power Grip This system provides a useful myo assessment tool for the upper extremity amputee and also provides an entertaining aid for use both pre and post prescription Co Contraction The black horizontal lines identity the co contraction level and can be adjusted as necessary The horizontal lines on the display area move simultaneously with the vertical slider Selecting Co Contraction opens a form shown below to monitor and set the co contraction signals m al AA i i aie Fr ER EI I RON wil ta s a m i _ M n In Mode 5 co contraction is used to move between he horizontal slider highlighted above centre left can default and alternate grip patterns The blue horizontal be used to set the co contraction time window ines show the on threshold level set during the myo configuration process and can be adjusted from this A co contraction signal is considered to exist when option if necessary signals from both channel 1 and 2 pass through both the on threshold and co contraction within a desig nated timeframe co contraction window 1 oh om With the bebionic hand there is a soft co contraction option where the co contraction threshold can be set lower than the on threshold level Providing that the peak
20. e as follows With the hand switched OFF press the button until the thumb begins to drive in Then release the button Caution Thumb adjustment MUST be done by a qualified technician or practitioner humb Adjustment To achieve certain grips it is necessary to adjust the thumb postion There are two different planes to move the thumb in and they are detailed below 2 An adjuster is provided to allow repositioning of the thumb for contact with either the index and middle fingers as in Ipod Grip or with index finger only as in Pinch and Precision Grips The thumb pivot assembly IS fitted with a slotted screw as shown in diagram 1 This acts to adjust the friction on an internal clamp and is loosened by tuming two complete turns and pushing the screw inward With the clamp slackened the thumb position can be manually re posttioned The assembly must be retightened before electrically arving the thumb A WARNING Please ensure screw is securely tightened before resuming use An adjuster nas also been provided to alter the baseline position of the thumb in order to optimise the contact point of the thumb tip against the opposing fingers for Triood Pinch and Precision Grips This is done by moving the thumb either towards the palm or away from the palm This adjuster is located under the thumb bracket as shown above Using a hex drive the adjuster should be turned clockwise to move the thumb towards the palm
21. e system components Including myo electrodes or other input devices battery systems wrists and cables We recommend RoLoteeper components for al of these requirements he oebionica hand is designed tor mid to moderate activities its use in situations where neaw loads vibrations or impacts may be encountered must be avoided Key 4 WARNING Texts with this symbol need special attention They contain information to do with safety D Caution Texts with this symbol draw your attention to potential sources of damage to the hand 1 1 Whats in tne box 1 bebionic radio frequency RF module 2 bebionica hand 3 bebionic tool kt 4 bebionic in car Charger 5 bebalance3 programming software 6 oebionico user guide f bebionica technical infomation OS 1 2 Princioal Dimensions e C ad e us HI Principal Dimensions Large Medium A Middle Finger Tip to Hand Base 200mm 190mm B Thumb Tip to Hand Base 125mm 121mm C Max Chassis Width no glove 92mm 84mm D Diameter of Chassis at Wrist o0mm o0mm Palm Circumference no glove 220mm 204mm Maximum Opening Width Tripod Grip 105mm with glove 105mm with glove Thumb Swing Through Angle 68 68 X EQD Only omm omm 00 1 3 Specifications Par Number ui eight Might a BBHLG QD 125mm 25mm 5989 bebionic3 Large Hand with EQD Wrist BBHLG SW 125mm 12mm 5779 bebionic3 Large Hand with Short Wrist BBHLG NA 125mm 16mm 5720 bebionic3 Large Hand with
22. een default and alternative grip pattern an OPEN OPEN signal must be applied i e the hana must be fuly opened the signal relaxed and then a second open signal supplied To alternate between the primary grip pattern table and secondary grip pattern table press the Programme Switch for less than 2 seconds he Auto Grip feature is tumed off Primary Opposed Default ripoq Alternative Power Primary Non Opposed Default Key Alternative Finger Point Secondary Opposed Default Active Index Alternative Tripod Secondary Non Opposed Default Column Alternative Mouse A 0 Programme Switch A Programme Switch is provided on the back of the nana This has four functions 1 Switch the hand ON and OFF A single press for approximately three seconds will switch the hand OFF A single press for more than two seconds will switch the hand ON 2 Alternate between the primary and secondary grip patterns When the hand is switched ON a single press of less than two seconds wil altemate between the primary ana secondary grip patterns nis will be accompanied by a short bleep and vibration if activated on bebalance 3 Enable disable the in hand RF module With the hand switched ON a single press for more than four seconds will enable the RF module Pressing the switch again for more than two seconds or disconnecting the power to the hand will disable the HF module 4 Enter exit glove mod
23. en the case with the higher level amputation With bebalances the practitioner may adjust the operation of the electrode reset co contraction signals Change signal timing features choose between one or two electrode or transducer control and enable the Auto Grip feature All are able to enhance the users natural contro capability bebalances software also provides the ability to record patient information and to record a nistory of configuration settings for each hand The programming of the hand requires a USB radio dongle Supplied to be plugged into the hosting computer which when activated links to the radio module in the beblonic3 hand There is also the capability to read the current configuration back from the hand and store it against the user record Caution This software is not intended for patient use Alterations should be made by the practitioner ONLY Caution Only bebionic v2 and bebionic3 hands can be programmed using bebalances 5 2 Installation c N Close all open applications A tn hele nsert CD into your CD ROM The application uses NET 4 0 Framework this will be installed f necessary Wait for Autorun bebalance uses an RF dongle to communicate with the hand Please remove the dongle from the USB port before running setup Follow Instructions on screen The RF dongle software is specific to the operating system An XP retro install on a Windows 7 computer you will need the W
24. ent However f you nave a question regarding a specific build not outline n this document please contact SLSteener ne oebionic hand may also be used with other manufacturers electrodes and wrists his means the bebicnicS nana can be fitted into an existing system without having to change every single component of tne system Al 20 4 1 Wrist Options There are currently 4 wrist options for tne oeolonic nana Alows the hand to be removed with a rotating action The EQD wrist allows the patient to quickly rotate and remove attach terminal devices as required Low profile connector for applications where there ls a long residual limo A short wrist lamination assembly is supplied attached to these hands ne hana can be rotated against a constant friction which can be adjusted by tne patient A hand plate with a threaded stud is pre fitted Two thread options can be supplied USA or European standards are available Interfaces with a RSLSteeper 50mm friction wrist part C12810 These hands are supplied pre fitted with a Friction Wrst nano plate The wrist has user adjustable friction that can be adjusted at any time through a simple twist action his option oroduces rotations througn a range of 320 degrees 29 4 2 Battery Options a WARNING Only the following battery options should be used with the bebionics Use of other battery systems is not recommended E 1 RS a BBI 2200 BBI 13
25. ependently adjusting on threshold and maximum levels of the individual channels on the hand Tenn Spo Contigo The off threshold is a predetermined offset from the on level The on level blue line determines the level the electrode signal must reach before it is active Once the signal reaches this level the hand operates until the Signal drops below the predetermined off level The maximum level red line sets the proportional range of the signal input With the signals displayed the electrode threshold and maximum levels can be adjusted with the relevant sliders which reposttion the blue and red horizontal ines in the associated display panels The strength of the signal ls displayed as a green vertical bar with the peak signal indicated as single green line On closing the form the settings are retained for configuring the hand using the Send to Hand option The embeddeo animation system enables modification of the threshold settings to be sampled without the need to keep sending data to the hand hese can then be sent to the hand once the user is comfortable with the settings The animation system can also be used as a pure training aid without the need for a bebionic hand However a training tower XXKXXXXX and radio module XXXXXXX will be required To tum on point amp click on Proportional Animation or Threshold Animation as highlighted below The animation shows Tripod Grip as the
26. indows version Please choose the appropriate version required from the menu below Install RF Dongle Driver for Windows 4000 XP or Vista Install RF Dongle Driver for Windows 7 Install bebalance Application Install dot Net Frame Work 4 0 only The defaut target directory is C users CP210 Win2K XP Vista or CP210 Win USERNAME Debalances You can choose an folder If using a retro operating system it may be alternative should you wish however it should necessary to use software specific to the computer be noted that it is essential that the bebalance buld application directory and sub directones have The latest version of the software can be found read amp write permission at WWw rslsteeper com downloads f setup falls to automatically open run it manually from the BBsetup exe bebalance V2 can co reside with bebalances f you are re installing bebalances the existing version MUST be uninstalled Although the existing database wil be retained it IS advised that the previous version is backed up before proceeding with this installation Tne bebalancesS application requires Net Framework 4 0 to operate If not installed it can be installed from the CD by opening dotNet Framework folder and double clicking on CotNetFx40_Full_ x86 x64 exe similarly the radio dongle requires software to be Installed to operate Specific versions can be found in og 40 ere Start up Gbionic gem 07 balance
27. mb Non opposed up to 4 grip patterns Mode 3 Control Strategy Single Site Proportional Threshold Alternating o OPEN hand the first signal wil OPEN the hand a configurable delay of 5Oms to 2 0s wll allow repeat OPENS f required To CLOSE hand a signal applied outside of the delay wll CLOSE the hand a configurable delay of 5Oms to 2 0s wil alow repeat CLOSES ff required Oo switch between default grip and altemative grp apply a further OPEN signal within variable time up to 2 seconds of the hand fully opening Grip Patterns Thumb Opposed up to 4 grip patterns Thumb Non opposed up to 4 grip patterns Mode 4 Control Strategy Dual Site Proportional Threshold OPEN OPEN o OPEN hand apply signal from OPEN electrode 10 CLOSE hand apply signal from CLOSE electrode o switch between default grp and altemative grp apply a further OPEN signal within variable time up to 2 seconds of the hand fully opening Grip Patterns humb Opposed up to 4 grip pattems Thumb Non opposed up to 4 grip pattems Mode 5 Control Strategy Dual Site Proportional Threshold Co contract o OPEN hand apply signal from OPEN electrode 10 CLOSE hand apply signal from CLOSE electrode o switch between default grp and altemative grp apply a co contraction signal Grip Patterns humb Opposed up to 4 grip pattems Thumb Non opposed
28. nd repalrs here are a number of field repairs and replacement parts that are avalable tor the bebionica Ihe instructions for how to do this are described in this section For further advice on any repairs please contact your bebionic distributor or emal enquines rsisteeoer com or both parts and service please mention that the hand is a bebionic3 hand including details as the whether t is Large or Medium Left or Might and the date of purchase 51 Oc epalrs e 7 Gaiter Removal 7 Pull the rear strap down and over the EQD to Tilt the hand backward and stretch the strap reveal the serial number on the back of the hand Over the bottom of the EQD pr i pa M Pull the garter away from the palm of the hand lakng care to avoid the thumb cable pull the making sure that the thumb cable stays in position gaiter over the thumb and off the bebionica hand _ Using the screwdriver with the 1 50mm hex bt Slide gaiter flaps out from under the rear cover contained within the toolkit loosen the screws In the rear cover Note Do not completely remove Es jJ Je gt a Note the thumb cable position as this is key when refitting a new gaiter f Completely remove the garter from the hand OO epalrs e 2 Gaiter Fefitting E m iis 7 Side the thumb section of the gaiter over the Ensure the thumb section of the gaiter is pushed thumb E
29. necessary for successful communication This radio transmitter ICID 10634A RSLRFBB has been approved by Industry Canada to operate with the antenna types listed below wth the maximum permissible gain and required antenna impedance for each antenna type indicated Antenna types not included In this list having a gain greater than the maximum gain indicated for that type are strictly pronibited for use with this device Name Mode 7488910245 Wurth 1 0 50 Ohm OEM Responsibilities The RSL RP609 Module has been certified for integration into products only by OEM Integrators under the following conditions 1 The antenna s must be installed such that a minimum separation distance of 20cm is maintained between the radiator antenna and all persons at all times 2 The transmitter module must not be co located or operating in conjunction with any other antenna or transmitter As long as the two conditions above are met further transmitter testing will not be required However the OEM integrator is still responsible for testing their end product for any additional compliance requirements required with this module installed for example digital device emissions PC perioneral requirements etc IMPORTANT NOTE In the event that these conditions can not be met for certain configurations or co location with another transmitter then Industry Canada certification is no longer considered valid and the IC Certification Number can not be
30. nic pivot removal pliers Part 908 274307 Alternatively the pivot can be removed with the pin punch provided in the tool kit avallable for purchase seperately Using a pair of standard pliers ensure that the pivot pin sits flush with the surface on both sides of the link Using a spare Clevice link the tool kit Place it Bend finger forward to align the holes for the pivot into the slot in the proximal Ensure that the curve pin of the clevice link curves away from the finger towards the palm Note Clevis curving towards the palm Ensure that the finger flexes fully forward and 8 Finished Springs back to the upright position as shown in the two images above oF 6 4 Quality Assurance RSLSteeper operate a UKAS approved quality management system and fully complies with the requirements of BS EN ISO 9001 2008 I5027001 2005 amp TicklT Issue 5 This certifies that RSLSteeper meet the appropriate international quality standards for design manufacture and supply of prosthetic products and user software RSLSteeper is registered with both the Medicines and Healthcare Regulatory Authority in the UK and the Food and Drugs Administration of the United States Government for the manufacture and supply of prosthetics and orthotics products MHRA Registration N CA001031 FDA Registration N 9612243 FCC Registration N PBBGC350616 IC 10634A RSLRFBB Model N RSL RP609 Continued compliance with the
31. nsure the gater strap is under the thumb al the way to the gap shown in the image above ray special attention to the thumb cable position LT ae gt i T 7 P ia z Fa aper E 3 Carefully push tne flao all the way home under the Ensure there is as small a gap as possible ear cover between the gater and the rear cover o4 gt Pull the gaiter strap around to the rear of the hana and up over the EQD wp au Retighten both of the screws in the rear cover Note Do NOT overtighten Line up the sections of the hand highlignted with the sections of the gater highlighted when pushing the gaiter flaps under the rear cover Pay special attention to the thumb cable position gt Finished OO O0 epalrs e 3 Clevis Link Replacement 7 The clevis link has been designed to bend snould the hand be excessively loaded curing use ff this should occur the part wil need to be replace so that the finger can be driven again Circle indicates correct side for inserting pivot pin Keeping the finger flexed use needle point pliers to insert the pivot pin through both parts of the Ink Note The pin is tapered and can only be inserted from the side with the circle detailed in image 5 1 Firstly ensure the thumb is in the non opposea position and that all of the fingers are fully driven open Ihen remove the pivot pin wih the bebio
32. o the screen highlighted below The features displayed wil be appropriate to the mode selected a iim LEPE _ bionic E ee Gamal emm f Grip Current tis possible to selet High Medium or Low Grip Current This setting provides adjustment of arp strength ana battery consumption the lower the setting the lower the grip and current draw Note This has minimal effect on operation speed opeed Control ohould you want to open or close the hand at less than maximum speed the numeric up down controls provide independent hand opening and closing speeds 4O default being maximum Timer Control For modes 1 2 3 amp 4 there are two numeric uo down controls to change mode timings Tne upper control Mode Change Period sets the window of time to search for a mode change signal In these modes additional signals received will have have no effect and will be considered to be the same signal The lower control Mode Return Period sets the period after which the mode reverts to default Where there has been no activity Setting the slider to zero deactivates the revert feature For Mode 5 there is no upper control as mode change is activated by a co contraction signal Dwell Threshold Upper amp Lower This feature is only used on Mode 1 The Upper control sets the time that the signal has to exist to be identified as a CLOSE signal The Lower control sets the value for the period a signal has to be held once considered an OPE
33. posed Secondary but with the thumb in the non opposed position Control Option The hand can be controlled by proportional or threshold electrodes or alternatively by linear transducers or force sensitive resistors It is possible to reverse the electrode transducer operation without the need to physically swap cables By simply clicking on the electrode radio buttons highlighted below l a CHER HIMEN XEM ANN ON bionic Change Indication Function change Indication is available by ticking either beep or vibrate both or none as highlighted below a CGNNEANC m ae rr EA A ni pd v pa 8 hans dC Opes s gra chee TO irp mn AS 44 Auto Grip This feature can be set to enabled or disabled Note that Auto Grip functions in Tripod Grip only Auto Grip is activated by providing three consecutive close signals De activation occurs when the hand is opened Re activation is made again by three consecutive close Signals motor position for movement if movement slippage of an object is detected the finger posttion ano force is automatically altered to provide a more secure grip Electronic monitoring of this process occurs every OOMS Horizontal Buttons Reset f at any time you want to start again with your configuration clicking Reset resets all the controls to the default settings for the current mode bionic ses
34. r transmitter 61 62 Radio Equipment Canadian Warning statements Radio Equipment Canadian Warning Statements English Under Industry Canada regulations this radio transmitter may only operate using an antenna of a type and maximum or lesser gain approved for the transmitter by Industry Canada To reduce potential radio interference to other users the antenna type and its gain should be so chosen that the equivalent isotropically radiated power e i r p is not more than that necessary for successful communication This device complies with Industry Canada licence exempt RSS standard s Operation is subject to the following two conditions 1 this device may not cause interference and 2 this device must accept any interference including interference that may cause undesired operation of the device French Conform ment a la r glementation d Industrie Canada le pr sent metteur radio peutfonctionner avec une antenne d un type et d un gain maximal ou inf rieur approuv pour l metteur par Industrie Canada Dans le but de r duire les risques de brouillage radio lectrique l intention des autres utilisateurs il faut choisir le type d antenne et son gain de sorte que la puissance isotrope rayonn e quivalente p r e ne d passe pas l intensit n cessaire l tablissement d une communication satisfaisante Le pr sent appareil est conforme aux CNR d Industrie Canada applicables aux appa
35. reils radio exempts de licence L exploitation est autoris e aux deux conditions suivantes 1 l appareil ne doit pas produire de brouillage et 2 l utilisateur de l appareil doit accepter tout brouillage radio lectrique subi m me si le brouillage est susceptible d en compromettre le fonctionnement To comply with industry Canada HF radiation exposure limits for general population the antenna s used for this transmitter must be installed such that a minimum separation distance of 20cm is maintained between the radiator antenna and all persons at all times and must not be co located or operating in conjunction with any other antenna or transmitter 0 5 Warranty Warranty Terms Item Warranty Period Warranty Terms bebionic Hand 12 months Design and Manufacture Cables 12 months Design and Manufacture Wrist 12 months Design and Manufacture Batteries Chargers 12 months Design and Manufacture correct charging Gloves 3 months Design and Manufacture not wear and tear An extended warranty is available for the bebionic hand providing additional cover for year 2 or years 24 3 Hand Policy Hands returned to the RSLSteeper bebionic service centres will be assessed and where deemed beyond repair will be replaced where a claim is made under warrant y this claim must be supported by appropriate documentation The warranty will be void on all system corr ponents if any components have been subject to abuse repair or maintenance by an un
36. signal does not exceed the on threshold a co contraction signal will be considered to exist The slider items highlighted on the image above are used to set the required characteristics of co contract signals Clicking Start will initiate tracing of the electrode signal One channel wil be displayed with raising signals moving upward and the second channel raising signals moving downward When the trace reaches the right hand side of the display it will stop To continue click Clear this will remove the previous trace and automatically start a new one if you wish to stop the trace at any point click Stop The display period can be changed by selecting the appropriate time period 10 20 or 30 seconds from the display period drop down top left A7 48 5 9 Advanced Features in bebalances the basic features can be selected by simply clicking on the appropriate radio button or check box control Adjustment of more specific features can be done by clicking Advanced m Ja a Jj bionic CEE ETE E e NN 1 quum A Le ped ge B mire m aif paa a y i m E lu We pas eee CEJA qup aa aca lans uw En p be a Legi Enr E x E os end E il ey R LL red rm a a a Most p Fest Lyri m B am a i ay a y Lo e Puna fie Bepe m Enr umm zm esse Css kat Tar m elo se ee LIN S a fe I a a sm a m ur Bee 1 q pris i mon This opens an overlay form similar t
37. tch charge module is fitted to the battery and requires an additional connector cable to Ink to the hand The connector cable for EQD hands as shown on page 32 is supplied with each battery For short wrist friction wrist or threaded stud wrist options a different connector cable CBBHA72 as shown on page 20 will need to be ordered separately and connected to the battery pack after removing B2 7804 A small laminating dummy is included in the kit Prior to lamination this is placed in a suitable location and orientation on the forearm model The position is chosen to allow sufficient space between the Inner and outer sockets and to allow easy access to the switch and plug point by the user A WARNING It is NOT recommended to route the power supply to the hand without passing through the switch 4 4 System Connections The system detailed below Is suitable for a bebionic hand with an Electronic Quick Disconnect Wrist BBI 2200 E 50 E 60 Please note Part B27804 is supplied with each battery pack and do not need to be ordered separately Components not to scale 32 The system detailed below is suitable for a bebionic hand with either a Short Wrist a Friction Wrist or a Threaded Stem bebionic f 4v 2200mAH battery bebionic f 4v bebionic 7 4v 1300MAH split 2200mAH split cell battery cell battery Battery Switch amp Charge Foint with Cable 2 X Electrode SU
38. te of purchase OO Notes Notes Notes Installation DISC Please refer to page 36 for Installtion Instructions WWW oebionic com oe contident RSLSTEEPER STEEPERUSA un Improving people s lives K Improving people s lives Technical support Technical Support Manufacturing Centre Unit 7 3619 Paesanos Parkway Hunslet Trading Estate Shavano Center Ill Suite 200 oevem Road oan Antonio 78231 Leeds L 510 1BL UK Texas USA Tel 44 0 119 270 4841 Tel 210 481 4126 e enaquines rsisteeper com e enauines steeoerusa com RSLLIT317 Issue 2 2012
39. ve donning mode the hand is first switched OFF The RF Module can be disabled by pressing for more than 2 seconds Alternatively you can disconnect the power to the hand by using the battery Switch 5 6 Operating Modes There are six modes Tnese are selected from the highlighted box along with the aopropnate control strategy Note Grip change wil generate a bleep and or vibration f this feature is enabled Mode O Control Strategy Single Site Thresnold o OPEN hand apply signal o CLOSE hand remove signa Grip Patterns humb Opposed up to 4 grip pattems Thumb Non opposed up to 2 ario patterns Mode 1 Control Strategy single Site Proportional Threshold o OPEN hand apply a short burst signal o CLOSE hand apply a sustained signal Oo switch between default arip and altemative grp apply a further OPEN signal within variable time up to 2 seconds of the hana Tully opening Grip Patterns Thumb Opposed up to 4 grip pattems Thumb Non opposed up to 4 grip patterns Mode 2 Control Strategy single Site Proportional Threshold o OPEN hand apply a quick rising stimulus o CLOSE hand apply a slow rising stimulus Lo switch between default grp and altemative grip apply a further OPEN signal within variable time up to 2 seconds of the hana fully opening Grip Patterns Thumb Opposed up to 4 grip patterns Thu
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