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Steeper operate a UKAS approved quality management system and fully complies with the requirements of BS EN ISO

9001:2008, ISO27001:2005 & TickIT Issue 5. This certifies that Steeper meet the appropriate international quality standards

for design, manufacture and supply of prosthetic products and user software.

Steeper 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).

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.

8747

6.2 Quality Assurance

Содержание BBHLG

Страница 1: ...1 Technical Manual BBHMD BBHLG...

Страница 2: ...2...

Страница 3: ...ng the bebionic glove 4 0 Connections Compatibility 17 21 4 1 Wrist Options 4 2 Battery Options 4 3 Power Information 4 4 System Connections 4 5 System Compatibility 5 0 bebalance 23 31 5 1 Introducti...

Страница 4: ...ability of the product and could impact product warranty WARNING We do not recommend the use of carbon fibre materials in fabricating a prosthetic arm due to electrical conductivity If however it is u...

Страница 5: ...e tripod grip 1 0 seconds maximum time to open or close power grip 0 5 seconds maximum time to open or close key grip 1 0 seconds maximum static load hook grip 99lb 3oz 45kg maximum load individual fi...

Страница 6: ...of grip 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 hand must be fully opened the signal...

Страница 7: ...The assembly must be retightened before electrically driving the thumb 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 app...

Страница 8: ...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 lids and pens Hook With the...

Страница 9: ...The thumb moves to the midpoint of its range and pauses The Index is then active and under user control To achieve this grip it is necessary for the thumb to be manually repositioned by the practitio...

Страница 10: ...ly close The thumb then closes onto the side of the index finger The thumb position may be raised and lowered without moving the other four fingers allowing for release capture or reposition of the ob...

Страница 11: ...ddle and ring fingers providing stability The index finger closes on to the mouse button and then backs off to provide the button press Each close signal will give a mouse click whilst an open signal...

Страница 12: ...12...

Страница 13: ...e has been designed specifically for use with the bebionic hand The use of other gloves may damage the hand and will void the warranty CAUTION 3 0 bebionic Glove Care Take care when fitting and using...

Страница 14: ...he hand is in glove donning mode CAUTION Do not use talcum powder or lubricant when fitting the glove CAUTION 3 4 Press and hold the program switch for six seconds The hand will automatically drive in...

Страница 15: ...ressing the program switch for approximately three seconds Next put the hand into glove donning mode by pressing the program switch for 4 seconds Roll up the base of the glove and pull the whole glove...

Страница 16: ...16...

Страница 17: ...y the patient Multi Flex Wrist The Flexion 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...

Страница 18: ...tery and requires an additional connector cable to link to the hand The connector cable for EQD hands as shown on page 19 is supplied with each battery For short wrist or friction wrist options a diff...

Страница 19: ...nts not to scale The system detailed below is suitable for a bebionic hand with an Electronic Quick Disconnect Multi Flex and Flex Wrist BBI 2200S bebionic 7 4V 2200mAh split or single cell battery B2...

Страница 20: ...rdered separately for hands with Short Wrist Components not to scale The system detailed below is suitable for a bebionic hand with a Short Wrist 13E190 150 connector BBI 2200S bebionic 7 4V 2200mAh s...

Страница 21: ...Otto Bock 9X50 9X52 Linear Transducer Supplier Part Number Name Otto Bock 12K44 ErgoArm Hybrid Plus Otto Bock 12K50 ErgoArm Electronic Plus Otto Bock 12K100N DynamicArm Otto Bock 12K110N DynamicArm Pl...

Страница 22: ...22...

Страница 23: ...ful if muscles produce limited or difficult to control signals as is often the case with higher level amputation With bebalance the practitioner may adjust the operation of the electrode reset co cont...

Страница 24: ...need to be un installed as this will run separately from bebalance Note Only one version of the bebalance software can run at any one time The bebalance software requires the Net Framework 4 0 to oper...

Страница 25: ...e medium large hands use either a red or black RF Dongle 4 2 1 3 5 4 Communications 5 4 1 Introduction To configure any bebionic hand for patient use the communications must first be enabled between t...

Страница 26: ...tly transmitting this button will show as stop scanning once device scanning is in progress If no devices are being listed then make sure that the bebionic hand has the communications turned on This c...

Страница 27: ...the user s ability to use their muscles to produce the required signals The number of electrodes used has an effect on which operating modes can be used The following clarifies this Dual Site Electrod...

Страница 28: ...the relevant tables Proportional Control The speed and strength of the hand is proportional to the electrode signal produced by the user Threshold Control The speed and strength of the hand is consta...

Страница 29: ...Back Time Grip Switch Time Direction Change Time Proportional Threshold Thumb Position Change Palm Switch Open Open Signal Mode 4 Open Open Signals Dual Site Electrode 2 x Transducers Open Apply sign...

Страница 30: ...three consecutive close signals Deactivation occurs when the hand is given an Open signal If movement slippage of an object is detected the finger position grip force is automatically altered to prov...

Страница 31: ...settings Communications This button gives us access to the communications form for connecting to all hands for both Bluetooth and RF USB dongles When a connection is made the communications status bo...

Страница 32: ...be used to do so No key is required to disable this feature 5 7 Electrodes To monitor review and adjust the electrode signals select the Electrode Screen button to view the Myo Configuration Trainer w...

Страница 33: ...t reaches the right hand side of the display click Stop The trace period can be changed by selecting the 10 20 or 30 seconds from the Display Period drop down menu The black horizontal lines identify...

Страница 34: ...34...

Страница 35: ...nty Re turns and Repairs 6 1 Repairs 1 2 The clevis link has been designed to bend should the hand be excessively loaded during use If this should occur the part will need to be replaced so that the f...

Страница 36: ...t pin sits flush with the surface on both sides of the leadscrew 7 8 Ensure that the finger flexes fully forward and springs back to the upright position as shown in the two images above Finished 3 4...

Страница 37: ...5 6 1 2 Using the screwdriver with the 1 50mm hex bit con tained within the toolkit loosen the screws in the rear cover Note Do not completely remove Slide gaiter flaps out from under the rear cover...

Страница 38: ...strap is under the thumb Pay special attention to the thumb cable position Ensure the thumb section of the gaiter is pushed all the way to the gap shown in the image above Pull the gaiter strap aroun...

Страница 39: ...ed Carefully push the flap all the way home under the rear cover Ensure there is as small a gap as possible between the gaiter and the rear cover Retighten both of the screws in the rear cover Note Do...

Страница 40: ...ored 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 The mark may be...

Страница 41: ...y 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 b...

Страница 42: ...ulations 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 u...

Страница 43: ...lude details on date of purchase size medium or large and side left or right If bebionic components are to be returned for servicing please contact us or your local distributor stating the hand s seri...

Страница 44: ...e a detrimental impact on health and the environment Please observe the instructions of your national authority pertaining to return and collection 6 7 Symbols Used Declaration of confirmity according...

Страница 45: ...45...

Страница 46: ...RSLLIT317 Issue 1 2017 www bebionic com Steeper Mayflower House 14 Pontefract Road Stourton LEEDS LS10 1TB Tel 44 0 870 240 4133 Email customerservices steepergroup com www steepergroup com...

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