technical information
Contents
1. co contraction signal is considered to exist when signals from both channel 1 and 2 pass through both the on threshold and co contraction within a desig nated timeframe co contraction window 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 Provding that the peak signal does not exceed the on threshold a co contraction signal will be considered to exist 43 44 5 9 Advanced Options in bebalance adjustment of more specific features can be acessed by clicking Advanced Ima oes Cs Li balance Cai e d imas i immo Uo 5 hum ee egre i Rz Ce EUR oma ida HE EG ET es mos bin E his opens a dialog box similar to the screen shown below Ihe features displayed will be appropriate to the mode selected mand Cioarig Sos 13 uds X tance Goce fares Mode LH bah em Lie ad lxx Grip Strength tis possible to select High Medium or Low Grip Strength This setting provides adjustment of grip strength and 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 10096 default being maximum Timer Control For modes 1 2 3 and 4 there are two numeri2. WE bionic RSLSIEEPER STEEPERUSA K Improving peoples lives K Improving people s lives 4 T C bionic Bohnica information X me is lamg pan 3m As mmm Contents TAGA E E EE E EEE ET QT EU Ur 04 07 n the Case 2 0 bebionic 2 1 PN Principal Dimensions 3 Specifications Cocco 06 17 Factory Settings Program Switch 2 3 Thumb Adjustment 2 4 PNG 3 O bebionic 3 1 32 GIG 4 0 Connect 4 1 4 2 ING 4 4 45 Opposed Grips on Opposed Grips out Tr 18 23 How to fit a bebionic Glove Removing a bebionic Glove Care Instructions for bebionic Glove One AS LEO NO SOIR Lotes Cosaeb et bed ado i oboe bonas adeat qtag a tetedt uertit 24 31 Wrist Options Battery Options Power Information system Connections system Compatibility SPONDS AP E E E Q2 44 5 1 OZ 5 3 A O 6 NG io 0 9 Or AN Er G O1 Introduction installation otart Up Language Selection Enabling blutooth BT Connection Operating Modes Hand Configuration Grp Selection Advanced 6 0 Additional Information Warranty Repairs and RELUMS ttre 46 55 0 DE 6 3 6 4 Clevis Link Replacement Quality Assurance Warranty Hetums 04 1 0 Introduction This document contains important information for the correct use and set up of tne bebolonic small hand Read this document thoroughly before fitting a bebioni
3. 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 ISOQAR AS a 3747 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 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 Hand Model RSL RP608 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 h
4. O WA gt diameter of chassis at wrist palm circumference no glove maximum opening width tripod grip thumb swing through angle X EQD only bionic Small 6 165mm 4 Vs 105mm 2 78 72MM 1 34 45mm 7 179mm 3 2 0mm 68 Ja 2mm 1 3 soeciications BBHSM QD W id tala a Aa mm 25mm 3909 BBHSM QD W F 4 ddp ard 160z bebionic small hand with Flex Wrist white 5mm 53MM 4609 BBHSM SW B M 4e ar 130z sestentie aneen wits Shak Wits o rect 5mm 12mm 3699 Build height comprises of thumb tip to base of hand measurement 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 Insert L for a left hand or R for a right hand maximum power grip force 140 1N maximum ipod grip force SN maximum key grip force 26 5N maximum tme to open or olose tipod gio DD Posee maximum time to open or close power grip 0 5 seconds maximum tme to open or se kay gio Posee maximum static load hook grip 991b 3oz 45kg maximum load indvidual finger hook grip 25K maximum finger tip extension load 13lb 3oz 6kg Of The bebionic small hand provides 14 different aro patterns allowing the user to have a more complete device to assist them in their day to day life The hand has two selectable thumb positions opposed and Non oooosed Opposed places the thumb in opposi
5. activated a stream of signals begin transmission The hand will automatically disconnect after every successful Send to Hand The success or failure of the process wil be shown on the screen The user wil be required to follow steps outlined in section 5 8 to re connect the Bluetooth communication to the hand if further programming is needed Ebalarice bamm Des i as Sm nom p H a ama aia a cmn ai om Cb Cee bonae Head from Hand This feature enables the current hand configuration to be read from the hand and stored in the history file olowing a read you are required to enter a patient identifier This enables retrieval of the specific patient configuration if desired Ebalarice IL bamm p nn i LE ee m amb oem bam D nie oH mom or FETE om i LI Tp ms E EU a Eum Tap A am g ean Fas m Bluetooth This enables connection of the Bluetooth communication to the hand When a connection is made the message box will be highlighted in green shown above If there is no connection with the hand the message box wil be highlighted in red shown below See section 5 8 for further Information balance sel EES ee len Re bee m uo a a rs ka og a a um s Pe eee 4 A Vertical Buttons Electrodes selecting Electrodes from tne vertical button menu opens a form see the myo configuration screen below This allows electrode signals t
6. back of the hand for approximately three seconds CAUTION Do not attempt to fit the glove unless the hand is in glove donning mode 3 Press and hola the program switch tor sx 4 Ihe thumb will be in the position shown seconds Ine hand wil automatically drive above when the hand is in glove mode into glove mode 20 CAUTION Do not use talcum powder or lubricant when fitting the glove 5 Fold up the base of the glove O Pull the glove over the hana f Ensure the fingers and thumb of the hand 8 Hold down the program switch for four align correctly with the fingers and thumb seconds to exit glove donning mode and of the glove begin using the hand 21 22 DEDIONIC glove 3 2 Removing the bebionic glove 1 Hrstly oppose the thumb Then tum the hand OFF by pressing the program switch for aporoxmatel three seconds Next out the hand into glove donning mode by oressing the program switch for 4 seconds 3 Do not pul the fingers individually as this can damage the glove and the hand 2 Roll up the base of the glove and pull the whole glove off from the back of the nand Exit glove donning mode by pressing ana holding the program switch for four seconds the hand will automatically drive out of glove donning mode and will be active in the default grip DEDIONIC glove 3 3 Care Instructions and Information Care Take care when fitting and using the bebionic glove Iry to avo
7. cannot be charged In this position The ON OFF switch 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 shomn on page 28 IS supplied with each battery For short wrist or friction wrist options a different connector cable CBBHA 2 as shown on page 29 will need to be ordered separately and connected to the battery pack In place of the EQD connector cable A small laminating dummy is included in the kit Prior to lamination this should be placed in a suitable location and orientation on the forearm model Ihe position chosen should allow sufficient space between the inner and outer sockets 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 Zt 4 4 System Connections The system detalled below is suitable for a bebionic hand with an Electronic Quick Disconnect and Flex Wrist Po BBI 2200S bebionic 7 4V 2200MAN split or single cell battery BBl 1300S bebionic 7 4V 1300mAN split cell battery B2 7804 battery switch and charge point with cable BEC SO EBECCO 2 x Electrode 5OHZ or 60H7 QDACO co axial plug Please note Part B27804 is supplied with each battery pack and will not need to be ordered separately Components not to scale 20 The system detailed below is
8. conjunction with any other antenna or transmitter 6 3 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 upto 5 years Hand Policy Hands returned to the bebionic service centres will be assessed and where deemed beyond repair will be replaced Where a claim is made under warranty this claim must be supported by appropriate documentation The warranty will be void on all system components if any components have been subject to abuse repair or maintenance by an uncertified 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 To identify the hand serial number see outer edge of locking ring above the wrist unit 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 necessary Please note Each bebionic hand is fitted with a passive Radi
9. suitable for a bebionic hand with a Short Wrist MA T BBI 1300S B bebionic 7 4V EDIONIC an 2200MAN split or 1300MAN split cel battery single cell battery B2 804 battery switch and charge paint with cable ELEC 50 EEECEO 2 x Electrode 5OHZ or GOHZ CBBHA72 connector cable Please note Part B27804 is supplied with each battery pack and will not need to be ordered separately however part CBBHA72 will need to be ordered separately for hands with Short Wrist Components not to scale 79 SO 4 5 system Compatibility The beoionic hand is potentially compatible with a number of different parts from other suppliers A common list is shown on the page opposite Please adhere to the advice given below 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 the design parameters of our system The statements above do not imply that RSLSteeper SteeperUSA recommend or warrant these combinations We believe based on the manufacturers literature that these combinations will work effectively However it is the responsibility of 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 recomme
10. to the Pinch Grip while losening the screw counter clockwise wil enable the thumb to move far enough to create pod Grip 2 32 Thumb Contact Point Adjuster An adjuster has also been provided to alter the baseline position of the thumb in order to optimize the contact point of the thumb tip against the opposing finger s for Tripod 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 and counterclockwise to move the thumb away from the palm The effect will not be observed while 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 opposite to the fingers Tripod When the thumb is opposed the hand closes into Tripod Grip with index and middle fingers meeting the thumb Ring and little fingers continue to close until they meet resistance or the close signal stops This type of grip allows users to pick up hold and manipulate a variety of everyday objects such as car keys COINS jar ids and pens Power With the thumb opposed all four fingers close into the palm until they meet resistance or the close signal stops When fingers are approaching a fully closed position the thumb drives In to cover tne fingers for addi
11. Auto Grip is active the electronics monitor motor position for movement ff movement slippage of an object is detected the finger position grip force is automatically altered to provide a more secure grip Electronic monitoring of this process occurs every oms Horizontal Buttons Restore Defaults f at any time you want to stat again with your configuration clicking Rstore Defaults reverts all the controls to the default settings for the current mode das mr jerm me pri E balarice ii as m DS EE pem es gee AC Save The hand can be configured and the settings sent to the hand without saving If you want to trial a configuration If you want to retain these settings for further amendment or back up click Save Before the data is saved a patient identifier must be entered There is a description field for recording specific information as necessary ill n es dues mn ssh balance 2 E kam Eh ELE pue Ue Re LN 5 ky m z UU RS GEU ee EON GE Em l LED mud s ln History Clicking History opens a list of saved configurations By entering a patient identifier and clicking Find you can filter the records This feature enables the recovery of previous settings for resending to the hand or providing a base to work from DE a DE LEUNO OGEE UEDCENU a WA y PRSE pee Be d bad 5 oend to Hand With tne BT Dongle inserted and configured and the bebionic hand
12. action The EQD wrist allows the patient to quickly rotate and remove or attach terminal devices as required Short Wrist Low profile connector for applications where there is a long residual limb A short wrist lamination assembly is supplied attached to these hands he hand can be rotated against a constant friction which can be adjusted by the patient Flexion Wrist The Hexion Wrist from Motion Control is a simple flexion device that allows the wearer to easily lock or unlock the wrist position and reposition the wrist in either a flexion or extension position ne mechanism allows the wist to be flexea or extended to 30 degrees in either direction and locked In eacn of the three positions 4 2 Battery Options A WARNING Only the following battery options should be used with the bebionic small Use of other battery systems is not recommended BBI 22005 Supplied with a removable shrink fit coating allowing the cells to be split for easier fitting in the prosthesis Tyoical Capacity 2200mAh Voltage Nominal 7 4v SKE eo es bM Un or 18 5 x 18 5 x 7 0 mm x2 when split Sa X 1 3 X D Ya 20 BBI 13005 Tvoical Capacity 1300mAh Voltage Nominal 7 4 V SEO Oo kO TRIB es 94 x198 x2 98 A 3 Power Information A WARNING System cables MUST NOT be cut while power is ON This will short the battery and damage the system Any damage caused in this way will void the bebionic warran
13. alance Zu ini WEM balance n Configuration essentialy changes the way the bebionic nand operates These changes are downloaded from the computer to the hand to allow the user to try them Successful alterations can be loaded and saved in the hand s memory Details of individual iteration once saved are witn the patient s ID in the History file CAUTION Only bebionic small hands can be programmed using bebalanceBT Hand Configuration Select bebionic on the main menu to open the configuration screen as shown below E m DE zr By default the configuration screen opens wth dua site control strategy You can change to single site Dy point and clicking on Single Site under mode 5 8 Grib Selection Grips can be selected and ordered as desired by the user by a simple point and click in the relevant tables E ges Emu ae mid balance pe unm LS Ur m B Har Es m Em ede Aa ES m nok see cr Opposed Primary This refers to selection of the initial two grip patterns available with 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 will 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 Th
14. ave a label stating Contains FCC ID QOQBLE 1 13 place on it inline with FCC labelling regulations The FCC and IC information is located on the wrist lock ring o1 502 INDUSTRY CANADA STATEMENTS 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 Under Industry Canada regulations this radio transmitter may only operate using an antenna of a tyoe 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 radio transmitter IC 5123A BGTBLE113 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 prohibited for use with this device Name Mode 7488910245 Wurth 1 0 50 Ohm OEM Responsibilities The BLE1 13 Module has been certified for integration into products only by OEM integrators under the followin
15. b Non opposed up to four grip pattems Mode 2 Control Strategy single Site Proportional 10 OPEN hand apply a quick rising stimulus 10 CLOSE hand apply a slow rising stimulus lo switch between default gno and altemative gri apply a further OPEN signal within variable time up to two seconds of the hand fully opening Grip Patterns Thumb Opposed up to four grip patterns Thumb Non Opposed up to four grip patterns NG Mode 3 Control Strategy single Site Proportional Threshold Alternating 1O0 OPEN hand the first signal wil OPEN the hand a configurable delay of 5Oms to 2 08 wil allow repeat OPENS f required 10 CLOSE hand a signal applied outside of the delay wil CLOSE the hand a configurable delay of 5Oms to 2 08 wil alow repeat CLOSES If required o switch between default grip and alternative grip apply a further OPEN signal within variable time up to two seconds of the hand fully opening Grip Patterns Thumb Opposed up to four gripo patterns Thumb Non Opposed up to four grip pattems Mode 4 Control Strategy Dual Site Proportional Threshold OPEN OPEN 10 OPEN hand apply signal rom OPEN electrode 10 CLOSE hand apply signal from CLOSE electrode o switch between default grip and alternative grip apply a further OPEN signal within variable time up to two seconds of the hand fully opening Grip Patterns Thumb Opposed up to four grip pattems Thumb Non oppos
16. c small hana A bebionic system is completed by adding trom a selection of compatible system components including electrodes or other input devices battery systems wrists and cables We recommend RSLSteeper SteeperUSA components The bebionic small hand is designed for mila to moderate actMtles Avoid use in situations with heaw loads viorations or impacts Key A WARNING Text with this symbol contain important safety information CAUTION Text with this symbol highlights potential sources of damage to the hand A WARNING The bebionic hand contains Electrostatic Sensitive Devices Any disassembly on this hand must be carried out by RSLSteeper authorised personnel in an Electrostatic Protected Area EPA Failure to do this could cause ESD damage which will affect the reliability of the product and could impact product warranty A WARNING We do not recommend the use of carbon fibre materials in fabricating a prosthetic arm due to electrical conductivity If however it is used then it is important to ground the carbon fibre lamination 1 1 In the Case 1 bebalanceB I bluetooth dongle 2 bebionic small hana o bebionic small tool kit 4 bebionic small user guide 5 bebionic small technical Information 6 bebalanoceB software CD OS N6 1 2 Princioal Dimensions Principal Dimensions middle finger tip to hand base thumb tip to hand base max chassis width no glove EN
17. c up down controls to change mode timings The 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 ana 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 and Lower This feature is only used on Mode 1 The Upper contro sets the time that the signal has to exist to be Identified asa CLOSE signal The Lower control sets the value for the period a signal has to be held once considered an OPEN signal Dwell Threshold Min and Max This feature is only used on Mode 2 The minimum control sets tne level that the signal nas 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 will be accepted as an additional same direction movement ff set to zero hand movement will alternate with the next detected signal EM jona intormation Wdkenly retums ano s s T 6 0 adi d There are a number of field repairs and replacement parts that are avallable tor the oebionic small Instruction
18. e an OPEN OPEN signal is used to change grip patterns This mode has been chosen to provide a standard solution that works well for the majority of users who demonstrate two well controled muscle signals However bebalanceB is particularly useful it muscles produce limited or difficult to control signals as is often the case with higher level amputation With bebalanceBT 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 control capability bebalanceB software also provides the ability to record patient information and to record a history of configuration settings for each hand The programming of the hand requires a USB bluetooth dongle supplied to be plugged into the hosting computer When activated the dongle will link to the bluetooth module in the bebionic small hand It is also possible to read the current configuration back from the hand and store against the user record CAUTION This software is not intended for patient use Alterations should be made by the practitioner ONLY Only bebionic bluetooth compatable hands can be programmed using bebalance BT 5 2 Installation WN gt Close all open applications Insert the bebalanceBl CD Wait for Autorun Follow Instructions on screen The default tar
19. ed up to four grip pattems Mode 5 Control Strategy Dual Site Proportional Threshold Co contract o OPEN hand apply signal rom OPEN electrode 10 CLOSE hand apply signal from CLOSE electrode Lo switch between default gnp and altemative grip apply a co contraction signal Grip Patterns Thumb Opposed up to four grip pattems Thumb Non Opposed up to four grip pattems In modes 4 and 5 the hand operate on the first signal that exceeds the ON THRESHOLD If an opposing Signal is received and exceeds the initial signal by a ore set ammount then tne larger signal wil become the dominant signal Please note Where more than one grio pattern is available the practitioner can select the default and alternative grios for both the primary and secondary grip pattems using bebalance programming software Pressing the program switch on the back of the hand alows the user to alternate between the primary and secondary set of grip pattems The hand will be delivered pre set to Mode 4 with default values set to provide an operational hand Straignt out of the box Therefore configuration via bebalance may not be essential pre fitting 5 Hand Configuration Introduction For most patients the factory settings on the bebionic hand will be adeguate However for experienced oracttioners bebalanceBl software can be used to customize the hand to each individual through the bebionic menu option E b
20. g Contains Transmitter Module IC 5123A BGTBLE1 13 Or Contains IC 5123A BGTBLE1 13 The OEM of the BLE1 13 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 user s 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 or transmitter OO o4 Radio Equipment Canadian Warming Statements Radio Equipment Canadian Warning Statements 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 exemp
21. g 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 he 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 peripheral 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 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 BLE113 Module is labeled with its own IO 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 followin
22. g the application the main screen shown above will appear Any greyed out options are currently not operational The area highlighted in red identities the bebalanceB version number and company information 5 4 Language Selection balarice HE Edd balance On the bottom left of the entry screen you can select your preferred language English French German Spanish Portuguese Italian Turkish Russian 5 5 Enabling Bluetooth BT Connection E m balaie Cemi inm B WE Tum ue Wale TSI EUH EH ha mre Ear a anm nnm nl rmm ET T Selecting the bebionic Hand tab in the top left hand corner of the entry screen will open the main selection screen Enabling bluetooth Module on the bebionic small hand Ensure the BT dongle is inserted into a USB port of the computer before continuing With the hand switched ON enable the BI module on the hand by pressing and holding the button on the back of the hand for approximately six seconds or until you hear a double beep vibrate indication Note his function differs from the glove conning mode To enable the BT communication the hand must be switched ON whereas in glove donning mode the nand must be switched OFF The BT communication can be disabled by pressing the button on the back of the hand for longer than two seconds Alternatively you can disconnect the power to tne hand by using the battery switch Click on the Bluetooth button in the top ri
23. get directory is C Program Hes xxx oebalanceBl You can choose an alternative however it is essentia that the application directory and sub directories have read and write oerrmission f setup falls to automatically open run it manually from the bebalanceB V setup exe f you are reinstalling oebalancebl the existing version MUST be uninstaled Although the existing database wil be retained it is advisable to back up the previous version before proceeding Youdo nat need to uninstall the bebalance software used for bebionic3 and bebionic V2 hands as this will run seperately from bebalance65 LG Welcome to the BebalanceBT Installation Pro E balance ral EebalanceB Applicaton Soflware katol NET V Frameveark View instal Bluetooth USB Drivers Document The bebalanceB T application requires Net Framework 4 O to operate If not already installed it can be Installed from the CD by opening dotNet Framework folder and double clicking on dotNetFx4O Ful x86 x64 exe similarly the bluetooth dongle requires software to be installed to operate Specific versions can be found in the BLED112 Windows Driver Folder If using a retro operating system it may be necessary to use software specific to the computer build The latest version of the software can be found at www bebionic com downloads bebalanceBT The password for the file is tuP 7ADE OO OO ort up be balance ve a On openin
24. ght hand corner of the screen highlighted above Doing this will open the dialog box shown above Click on Device Scan highlighted above The system wil automatically start to scan for bebionic devices Pot Baga Duacmch Los Baa KU bation Devices Status Connected CONE 1 devticeis andi select your device and press the Middle right hand button Connect highlighted above The dialog box wil automatically close once the connection is made p m r imr m Ln Once connected you should notice a green connection box on your main selection screen highlighted above 5 6 Operating Modes There are sx modes Ihese are selected from the highlighted box along with the appropnate control option Note Grip change will generate a bleep and or vibration f this feature is enabled UA LL a rn E balarice Mode O Control Strategy Single Site Threshold 10 OPEN hand apply signal o CLOSE hand remove signal Grip Patterns Thumb Opposed up to three grip patterns Thumb Non Opposed up to two grip pattems Mode 1 Control strategy Single Site Threshold 10 OPEN hand apply a short burst signal 10 CLOSE hand apply a sustained signal o switch between default grip and alternative grip apply a further OPEN signal within variable time up to two seconds of the hand fully opening Grip Patterns Thumb Opposed up to four gnp pattems Thum
25. id contact with sharp or pointed objects High Definition Nails Silicone gloves have nails painted by hand following the manufacturing process We do not recommend the use of polystyrene nails attached with Oyano 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 After cleaning remove all traces of the cleaner and wipe the surface dry Most dyes wil be fully removea by this process A liquid domestic fabric softener can be diluted to reduce the tackiness of the surface Tne material used will resist most staining media For any other enguines please contact your loca supplier 2e bionic 4 Q connections and compatiollity beblonic system Is very versatile ano allows a number of different power and connectivity options Most options are detailed in the following section of this document However f you have a question regarding a specific build not outlined in this document please contact your local supplier The oebionic hand may also be used with other manufacturers electrodes and wrists his means the bebionic small hand can be fitted Into an existing system without having to change every single component 29 4 1 Wrist Options nee are currently three wrist options for the bebionic small hana Flectric Quick Disconnect EQD Allows the hand to be removed with a rotating
26. is enables selection of a further two grip patterns with the thumb in the opposed position These grips are activated by pressing the program switch on the back of the hand As with the primary grip pattems the user can switch between the default and the alternate grip by applying the appropriate change signal The user can retum to the primary grip pattems by pressing the program switch Non Opposed Secondary This refers to the arip pattems as described for Cpposed Secondary but with the thumb in the Non Opposed DOSIION 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 simply select the appropriate configuration as highlighted in screen below T m m Pme a wiw balance m brm Ed LEJ pe e Maga bp _ US U EWUU SLR GNU ee SN AS Change Indication Function change indication is available by selecting either beep and or vibrate as highlighted below E men e s i ee In Auto Grip This feature can be set to enabled or disabled Please note that Auto Grip functions in Tripod Grip only Auto Grip is activated by providing three consecutive close signals Deactivation occurs when the hand is opened Heactivation is made again by three consecutive close Signals Wa Ll ai Cla Mg ee When
27. lly driven in toward the palm AI the fingers are driven to a slightly flexed position Appling a further signal will drive the fingers Into Hook Grip for a carrying position Open Palm With the thumb in the non opposed position the hand may be fully opened to provide a flat palm suitable for carrying a tray or a plate ofebionic glove ne bebionic glove is made from a multi layered variable hardness slicone based material lined with fabric mesh This construction resists soling wear and puncture damage oebionic gloves provide high compliance with gniooed objects INe fabric liner allows the glove to slide over the joints during motion this reduces the amount of power need to drive the hand and conserves battery lite The standard glove is supplied in 19 skin tones and in a sold black color oebionic gloves provide an additional barrier to dirt dust and moisture ingress to the nand Direct exposure to water or situations where dirt and dust are prevalent should be avoided as these nave the potentia to Interfere with or damage the hands oertomnance CAUTION The bebionic glove has been designed specifically for use with the bebionic hand The use of other gloves may damage the hand and will void the warranty DEDIONIC glove 3 1 Fitting the oeolonic glove 1 Move the thumb into the opposed 2 Switch the hand OFF by pressing down the position orogram switch on the
28. nd HSLSteeper SteeperUSA FLECSO or ELECEO Both are available to purchase and are optimized for use with bebionic small Inputs RSLSteeper SteeperUSA ELECSO and EEECSO Myoelectrode medo Sissi 5207 MyoBock Electrode Ine 200 Hemove Myo electrode Motion Control 3010426 Snap Electrodes Elbows Otto Bock 12K44 ErgoArm Hybrid Plus BE330 Boston Elbow Digital Wrist Duro Beck 10817 136205 Wrist Rotator and MyoRotronic Program 1 Two Electrodes Fast Rise bebionic Mode 4 Two Electrodes Safety Co bebionic Mode 4 Contraction One Electrode or One Linear ae Program 5 AGA SANA AGA bebionic Mode O and Mode 3 Program 3 Please note Devices or components not listed above are not recommended OT A 6 C v 5 O operating Instructions bebalance has been designed to give you optimum control over the new oebionic small hand features many new tools which wil help you and your patients optimize and customize the tunction of the nand Language selection electrode configuration with a simulation preview and simplified menu systems are al ncludec in bebalance6 CAUTION Please DO NOT program or control a bebionic system with unapproved alternative software or hardware systems Doing so will void the warranty OO 34 5 1 Introduction Out of the box the bebionic hand is preconfigured with two site threshold myoelectrc control Mode 4 wher
29. nly TY a f Ensure that the finger flexes fully forward 8 Finished and springs back to the upright position as shown in the two images above 49 6 2 Quality Assurance RSLSteeper SteeperUSA operate a UKAS approved quality management system and fully complies with the requirements of BS EN ISO 9001 2008 ISO27001 2005 8 TickIT Issue 5 This certifies that RSLSteeper SteeperUSA 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 QOQBLE113 IC 5123A BGTBLE113 Model N RSL RP608 Continued compliance with the standard is monitored by a programme of internal and external audits All individual products are marked indicating that they comply with the requirements of the Medical Devices Directive 93 42 EEC MDD Thek 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
30. non opposea thumb position the four fingers partially close ne thump then closes onto the side of the index finger he thumb position may be raised and lowered without moving tne other four fingers allowing tor release capture or reposition of the object being aripoed ihis pattern is ideal for carrying paper or letters using a spoon and for holding a thin flat object such as a plate a credit cara or a key Finger Point With the thumb in the non opposed setting the user can Move to Finger Point position ne middle ring ana little fingers close against the balm and the thumb moves against the midcle finger With this arp typing on a keyboard or input pad pressing a bell or a button can be achieved Column This grip moves the thumb into the palm from a non opposed position The fingers then close over the thumb to provide a fixed column that can be used as a way to push heaver objects or larger buttons and switches Column is also the recommended grip for dressing as the thumb is kept out of the way Mouse The thumb and Itte finger close to hola the side of the mouse with tne middle and ring fingers providing stability The index finger closes on to the mouse button and then backs off to provide tne button press Each close Signal will give a mouse click whilst an open signal will release the mouse Helaxed Hand The thumb is set to the non opposed position and partia
31. o Frequency Identity Device to allow identification and trace during manufacture and in case of return to our bebionic service centres 6 4 Returns If bebionic components are to be returned for servicing please contact us or your local distributor stating the hand s serial number We will issue a returns number and returns form that will need completeing in full so your request can be dealt with promptly Spare 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 us For both parts and service please mention that the hand is a bebionic small hand include details on date of purchase size small and side left or right OO oe confident oe IN control WWW DEDIONIC COM RSLSTEEPER STEEPERUSA S Improving people s lives n Improving people s lives Prosthetics Division Unit 7 3619 Paesanos Parkway Hunslet Trading Estate vU 2200 oevem Hoad oan Antonio Leeds L510 1BL UK Too Tel 44 O 870 240 4133 Te 210728 4126 e enqures rsisteeper com e inquinesQgsteeperusa com E Lee a 204
32. o be monitored reviewed and adjusted T m A r balance m kaka Ed LED d ees C ES m c LE Uh LE D UOLANEDSUESOEN NG Ki Has Eb us oe The sliders highlighted on the screen below are for independently adjusting on threshold and maximum levels of the individual channels on the hand 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 maximur level red line sets the proportional range of the signal input With the signals displayed the electrode threshold and maximum levels can be adjusted using the relevant Sliders The strength of the signal is displayed as a green vertical bar with the peak signal indicated as single green ine On closing the form the settings are retained for configuring the hand using the Send to Hand option The embedded 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 he animation will open and close in response to the electrode signals This system provides a useful myo assessment too for the upper extremity amputee and also provides a training aid for use both p
33. re and post prescription Co contraction selecting Co contraction opens a form shown below to monitor and set the co contraction signals This option is only available when Mode 5 is selected from the drop down menu In Mode 5 co contraction is used to move between default and alternate grip patterns The blue horizontal ines show the on threshold level set during the myo configuration process and can be adjusted from this option If necessary 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 will 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 stoo To continue click Clear this will remove tne previous trace and automatically start a new one if you wish to stop the trace at any point click Stop The display penod can be changed by selecting the appropriate time period 10 20 or 30 seconds from the display period drop down menu top left The black horizontal lines identify the co contraction level and can be adjusted as necessary The horizontal lines on tne display area move simultaneously with the vertical slider The horizontal slider highlighted above centre left can be used to set the co contraction time window
34. s are set out in this section For further advice on any repairs olease contact your local supplier or email oeoionicGrsisteeper com or both parts and service please mention that the hand is a oebionic small hand incluce details on date of purchase size small and side left or right A7 48 Aepalrg 6 1 Clevs Link Replacement pa B P 1 The clevis link has been designed to bend 2 Firsty ensure the thumb is in the should tne nana be excessively loaded non opposed position and that al of the during use If this should occur the part wil fingers are fully driven open Then remove the need to be replaced so that the finger can oivot pin between the clevs and leadscrew be driven again with the bebionic pivot removal pliers Part 274307 Alternatively the pivot can be removed with the pin punch provided in the tool kit avallable for purchase seperately 3 Using a spare clevis link assembly from the 4 Bend finger forward to align the holes for the tool kit Place it into the slot in the proximal olvot pin Ensure that the curve of the clevis link curves away trom the finger towards the palm 5 Keeping the finger flexed use needle point 6 Using a pair of standard oliers ensure that ollers to insert the pivot pin through both the pivot pin sits fush with the surface on parts of the link both sides of the leadscrew Note he pin is tapered and can be inserted amp removed from one side o
35. t RSS standards 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 Conform ment a la r glementation d Industrie Canada le present emetteur 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 a 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 i 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 appareils 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 meme 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
36. te between the primary and secondary grip patterns When the hand is switched ON a single press of less than two seconds will altemate between the primary ana secondary grp patterns This wil be accompanied by a short bleep and vibration If activated on bebalance 3 Enable disable the in hand bluetooth module With the hand switched ON a single press for more than SX seconds will enable the bluetooth module double beep vibrate wil indicate connection has been made Pressing the switch again for more than two seconds or disconnecting the power to the hand will disable the bluetooth module 4 Enter exit glove mode as follows With the hand switched OFF press the switch until the thumb begins to drive in Then release the switch For more information please see page 20 CAUTION Thumb adjustment MUST be completed by a qualified technician or practitioner 2 9 humb Adjustment To achieve certain grips it is necessary to adjust the thumb position There are two different planes to move the thumb in as detailed below An adjuster is provided to allow repositioning of the thumb for contact with either the index and middie fingers as in Tripod Grip or with index finger only as in Pinch and Precision Grips The thumb pivot assembly is fitted with a hex screw as shown above This acts to adjust the endstop of the thumb when in the opposed position Tightening the screw clockwise will bring the thumb closer
37. tion to the fingers on the hand Allowing grips like Iripod and Power Non Opposed places the thumb parallel with the fingers of the hand and allows grips like Key and Finger Point Non Opposed OY Introduction 2 1 Factory Settings The hand is supplied preset in Mode 4 Tnis provides two input operation with proportional control of ario and Speed Speed and grip force are set to maximum To alternate between the default and alternative grip pattern an OPEN OPEN signal must be applied i e the nand must be fully 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 Program Switch for less than two seconds The Auto Grip feature is tumed off Factory setting grips f your hand has been reprogrammed prior to delivery individual settings will vary Primary Opposed Default Ipod Alternative Power Primary Non Opposed Default Key Alternative Finger Point Secondary Opposed Default Active Index Alternative Tripod Secondary Non Opposed Default Column Alternative Mouse 2 2 Program Switch A Program switch is provided on the back of the hand This has four functions 1 Switch the hand ON and OFF A single press for approximately three seconds wil switch the hand OFF A single press for more than two seconds will switch the hand ON 2 Alterna
38. tional grip security This pattern allows round objects such as a ball or a piece of fruit to be held securely This gnp can also provide a handshake Cylindrical shaped objects such as bottles home and garden utensil handles are also held easily and securely A SERIOUS WARNING The bebionic hand MUST NOT be used to operate a firearm Hook With the thumb in opposed position a partially closed Power Grip provides Hook Grip This is ideal for carrying a shopping bag or briefcase Hook Grip can also be achieved by closing the fingers from the relaxed hand position Active Index With the thumb opposed Active Index Grip wil grasp tne handle of an object with tne Middle ring and little fingers and secure the grip with the thumb The index finger will then close this may be positioned over the lever of the device held such as a spray bottle it also offers tne idea finger position for typing The index finger is under independent user control and may be positioned accoraingly o exit Active Index an open signal Will fully open the index finger before the other fingers ana thumb release their grip Finger Adduction The fingers of the bebionic hana move together naturally as the fingers close This allows the user to securely grip thin objects such as cutlery or a toothbrush between tne fingers to achieve function In a different plane Finger Adduction is most functional with the hand in Power Grip b
39. ty 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 ow Power Condition When the battery capacity approaches Its lower limit the hand operation will slow down and begin to respond only to OPEN signals This occurs to ensure the hand stops in an open position to prevent the hand becoming locked onto an object when the power has been completely drained from the battery The battery must be recharged for further use CAUTION When attaching or detaching a bebionic hand to from a prosthesis it is important to first disconnect power by moving the battery switch to the OFF position This is to avoid a potential current surge to the hand when it connects disconnects with the power source A WARNING The prosthesis MUST NOT be worn whilst the batteries are charging Battery Switch Charging Module An ON OFF switch is integrated into the charge module The switch disconnects power completely and has two positions When the switch is positioned closest to the charge port 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 The battery
40. ut can also be achieved with the hand in Key Grp and Pinch Grip Pinch The thumb only contacts Index finger and is used for the fine manipulation of objects lo achieve this grip it is necessary for the thumb to be manually repositioned by the practitioner technician so that the thumb only contacts the index finger See section 2 3 Precision Closed This gro can be used in situations similar to the Precision Open Grip but where extended fingers would be obstructive such as working at a desk Initially the middle ring and little fingers close into the palm The thumb moves to the midpoint of tts range and pauses he naex is then active and under user control To achieve this grip it is necessary for the thumb to be manually repositioned by the oractitioner technician so that the thumb only contacts the index finger Precision Open With the thumb opposed the index finger meets the static thumb allowing the user to pick up and manipulate small objects When this grip Is selected and a close signal is applied the thumb closes to the midpoint of its range and pauses Ihe index is then active and uncer user control The middle ring and little fingers remain extended To achieve this grip it is necessary for the thumb to be manually repositioned by the oractitioner tecnnician so that the thumb only contacts the index finger 2 5 Non Opposed Thumb is inline with the palm 4 Key In the
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