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2- PATIENT POPULATION, ACTIVITY LEVEL, WEIGHT 

LIMITATIONS

 

 

Target patient population

  

Lower limb amputees, both transfemoral and transtibial.  

The device is for single patient use. 

 

The device is indicated for medium to high activity level (K3 and K4 activity levels; can 

be beneficial also for high K2). 

 

 

Activity Level K2: single speed cadence, with the ability to traverse low level 

environmental barriers. Typical of the limited community ambulator. 

 

Activity  Level  K3:  variable  cadence,  with  the  ability  to  traverse  most 

environmental barriers. May have vocational, therapeutic, or exercise activity 

that demands prosthetic utilization beyond simple locomotion. 

 

Activity Level K4: variable cadence, with 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 (p loads) does 

not exceed the weight limit indicated in the chart below. 

 

  

SIZE 

(cm) 

Activity K2 

Low 

Activity K3 

Medium 

Activity K4 

High 

BioStep CL 

BioStep PRO 

 

22-24 

113 kg / 250 lbs 

101 kg / 224 lbs 

101 kg / 225 lbs 

25-30 

183 kg / 405 lbs 

183 kg / 405 lbs 

147 kg / 325 lbs 

BioStep XT 

22-30 

152 kg / 335 lbs 

140 kg /310 lbs 

120 kg / 265 lbs 

BioStep EVO 

22 

113 kg / 250 lbs 

102 kg / 224 lbs 

90 kg / 200 lbs 

23-24 

125 kg / 275 lbs 

113 kg / 250 lbs 

102 kg / 224 lbs 

25-30 

158 kg / 350 lbs 

147 kg / 325 lbs 

125 kg / 275 lbs 

BioStep LP 

 

22-24 

100 kg/221 lbs 

88 kg/194 lbs 

 

77 kg /177 lbs 

25-30 

165 kg/365 lbs 

147 kg/324 lbs 

130 kg/287 lbs 

 

 

Содержание BioStep

Страница 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 ...

Страница 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...

Страница 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...

Страница 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 ...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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 ...

Страница 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...

Страница 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 ...

Страница 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...

Страница 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...

Страница 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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