Alps Electric BioStep User manual

1
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

2
1 - DESCRIPTION
The device is a prosthetic foot ith integrated male pyramid. It is composed of a
carbon fiber keel connected to a calf shank.
The structural elements are protected by a spectra sock and covered by a cosmetic
foot shell.
Biostep CL, Biostep PRO, Biostep XT -
Part list
Biostep EVO Part list
Biostep LP - Part list Spectra soc and cosmetic foot shell
Intended use
The device is intended to be used as a part of a lo er limb prosthetic leg. The device
replaces the foot and ankle function of the missing lo er limb for patients ith belo
or above knee amputation.
The device must be fitted and adjusted by a certified professional.

3
2- PATIENT POPULATION, ACTIVITY LEVEL, WEIGHT
LIMITATIONS
Target patient population
Lo er 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, ith the ability to traverse lo level
environmental barriers. Typical of the limited community ambulator.
Activity Level K3: variable cadence, ith 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, ith 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. Ris of device failure.
Lifting and carrying loads. Verify that the accumulated eight (patient + loads) does
not exceed the eight limit indicated in the chart belo .
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

4
3 – LIMITATIONS AND CONTRAINDICATIONS
Weight limit, activity level, carrying loads
Do not exceed the weight limits reported in the above chart. Ris of device failure.
Intended Life
This device has been tested according to ISO 10328 standard to t o million load cycles.
Depending on the amputee’s activity this corresponds to t o to three years of use.
For an extended use beyond this time frame, periodic safety checks are
recommended, taking into consideration the level and the type of activities performed
ith the prosthetic leg, the user eight, the effective operating time of the product.
Inspect the device and discontinue the use in case of signs of ear or deterioration.
Environment
The device can be used in temperatures bet een -23° C (–10° F) and 93°C (200° F).
The device is eather proof: it is not intended for patient activities that ill routinely
and repeatedly cause the foot to be submerged in salt or chlorinated ater or to be
exposed to corrosive environments (such as sand, mud or salt ater).
If occasional submersion/contact occurs, the follo ing protocol must be follo ed by
a certified professional:
Remove foot shell and spectra sock
Rinse the foot shell, spectra sock, and the foot ith tap ater
Thoroughly dry the foot shell, spectra sock, ankle shank, foot keel, and
proximal pyramid components ith a clean to el
A household hair dryer on a lo to medium heat setting can be utilized to
facilitate the drying process

5
4 - SAFETY INFORMATION AND WARNINGS
The certified professional must inform the patient about everything in this
document that is required for safe use of this device.
Warnings for the professional user
Accessories. The device must be used ith a foot cover (foot shell) and
spectra sock, supplied ith the product.
Product selection. Carbon fiber elements (calf/shank and keel) come in
different grades of stiffness, based on the activity level and eight of the
patient. An incorrect selection may result in poor device function or increased
risk of product failure. For appropriate selection, e recommend using our
online product code selector or contacting our customer service.
Maximum patient weight. Do not exceed the eight limit. Ris of device
failure.
Lifting and carrying loads. The accumulated eight (patient + loads) must not
exceed the maximum eight limit. Ris of device failure.
Installation and maintenance of the device. Installation 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 edge, connecting the device to the prosthetic
leg, aligning the prosthetic leg.
Visual chec . Visually check for product integrity before installation.
Connection with the prosthetic leg. Before delivering the prosthetic leg to
the patient, make sure Loctite has been applied to the scre s of the
connecting adaptors and that the appropriate torque has been applied, as per
the manufacturer's indications.
Installation of the wedge. BioStep EVO and BioStep LP are supplied ith a
edge to adjust the heel stiffness. Once the appropriate heel edge has been
determined, secure the heel edge ith Loctite 495 Instant Adhesive (or
equivalent). Do not force the edge for ard to ards the bolts or
unnecessary stress ill cause bolts to fail prematurely. Please check fitting
and alignment instruction section.
Device failure. Failure of the device may lead the patient to fall and could
lead to broken bones or other injuries requiring medical treatment.