Alps Electric BioStep Instructions For Use Manual Download | Manualshive

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INSTRUCTION FOR USE

BioStep

TM

BSEVO

BioStep EVO

BSPRO

BioStep PRO

BSCL

BioStep Classic

BSXT

BioStep EVO

BSLP

BioStep PRO

This manual is intended for use by a certified professional

EN

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Summary of Contents for BioStep

Page 1: ...1 INSTRUCTION FOR USE BioStepTM BSEVO BioStep EVO BSPRO BioStep PRO BSCL BioStep Classic BSXT BioStep EVO BSLP BioStep PRO This manual is intended for use by a certified professional EN ...

Page 2: ...metic foot shell Biostep CL Biostep PRO Biostep XT Part list Biostep EVO Part list Biostep LP Part list Spectra sock and cosmetic foot shell Intended use The device is intended to be used as a part of a lower limb prosthetic leg The device replaces the foot and ankle function of the missing lower limb for patients with below or above knee amputation The device must be fitted and adjusted by a cert...

Page 3: ...the ability for prosthetic ambulation that exceeds basic ambulation skills exhibiting high impact stress or energy levels Maximum patient weight Do not exceed the weight limit indicated in the chart below Risk of device failure Lifting and carrying loads Verify that the accumulated weight patient loads does not exceed the weight limit indicated in the chart below SIZE cm Activity K2 Low Activity K...

Page 4: ... discontinue the use in case of signs of wear or deterioration Environment The device can be used in temperatures between 23 C 10 F and 93 C 200 F The device is weather proof it is not intended for patient activities that will routinely and repeatedly cause the foot to be submerged in salt or chlorinated water or to be exposed to corrosive environments such as sand mud or salt water If occasional ...

Page 5: ... and maintenance must be carried out only by a certified professional These activities include removing and donning the foot shell inspecting and replacing the spectra sock installation of the heel wedge connecting the device to the prosthetic leg aligning the prosthetic leg Visual check Visually check for product integrity before installation Connection with the prosthetic leg Before delivering t...

Page 6: ...oise o the device shows signs of damage or wear o the patient has increased levels of physical activity with his prosthetic leg o If the patient experiences a weight gain equal to or greater than 20 lbs 9 1 kg Correct use and maintenance of the device The patient should be further informed that o wearing a shoe with an extreme heel height or walking barefoot may result in a misalignment of the pro...

Page 7: ... of the socket should run 25 50 mm anterior to the midline of the male pyramid with top of pyramid parallel to the ground with a 10 mm heel rise For the initial bench alignment run the midline of the socket through the front of the top pyramid bolt as shown Dynamic alignment Adapt the prosthetic alignment adjustments and or sliding adjustments in order to ensure correct heel contact easy roll over...

Page 8: ... adjustments in order to ensure correct heel contact easy roll over and optimal shifting of weight onto the contralateral side For transtibial amputees please ensure there is physiological knee flexion during stance phase Adjusting the heel resistance The foot is supplied with a heel wedge to increase the heel stiffness To soften the heel shorten the wedge by cutting along the cut lines For tempor...

Page 9: ...ck of keel to back of heel wedge mm Keel size length Measurement mm 22 24 40 25 27 43 28 30 48 BIOSTEP LP fitting and alignment instructions Static alignment Divide the socket in half The midline of the socket should run 15 50 mm anterior to the midline of the male pyramid with top of pyramid parallel to the ground with a 10 mm heel rise the midline of the socket will roughly divide the foot in 1 ...

Page 10: ...foot is supplied with a heel wedge to increase the heel stiffness For temporary installation secure with double sided tape For permanent installation secure the heel wedge with Loctite 495 Instant Adhesive or equivalent Red Wedge Medium Blue Wedge Firm Note Only install one wedge at a time per patient Attention Do not force the wedge forward towards the bolts or unnecessary stress will cause bolts...

Page 11: ... into the foot shell move the shoehorn up to fully push the foot into the foot shell verify that the foot s carbon structure is firmly seated into the foot shell and does not move up down the spectra sock must be pulled up to prevent it from interfering with moving parts of the foot 7 USAGE Cleaning and Care Clean with a damp cloth and a mild soap Dry with a cloth after cleaning 8 MAINTENANCE The ...

Page 12: ... bolts and titanium elements 6 months warranty on foot shell 1 month warranty on the spectra sock Specific exclusions from this warranty are devices used beyond the recommended use conditions in adverse environmental conditions or without respecting weight bearing limits devices not fitted appropriately according to the instructions for use devices not maintained as directed The user should be awa...

Page 13: ...ational environmental regulations The device is a composite of different materials metal carbon fiber epoxy resin sealant and should be treated as mixed and undifferentiated materials Please verify your local and national environmental regulation and dispose in accordingly CE Conformity This product meets the requirements of the European Regulation EU2017 745 for medical devices This product has b...

Page 14: ...rtner4U Esdoornlaan 13 3951DB Maarn The Netherlands www cepartner4u com UK RESPONSIBLE PERSON UKCApartner4U 7 Campion Way Bingham Nottingham NG13 8TR United Kingdom www ukcapartner4u com EC IMPORTER ALPS CZECH ENGINEERING s r o Božkovské náměstí 17 21 32600 Plzeň Czech Republic Tel 420 377 223 127 Fax 420 377 223 010 info easyliner eu www easyliner eu 4403 02734 3E3 A ...

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