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.

6
No modification of the device. The device should not be modified by cutting
or grinding the calf shank or foot keel; fasteners, set to the proper tension
and sealed ith Loctite, should not be loosened. Any structural alterations or
adjustments made by the certified professional or by the patient may create
liability and ill void the product arranty.
Warnings for the patient
Please explain this section to the patient before delivering the device.
Change in performance, weight, activity
oPatient must immediately contact a certified professional and
discontinue the use of the device until an accurate inspection is
performed by the certified professional in the follo ing cases:
othere is a change or loss in device performance or functionality
ounusual noise
othe device sho s signs of damage or ear
othe patient has increased levels of physical activity ith his prosthetic
leg
oIf the patient experiences a eight 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:
oearing a shoe ith an extreme heel height or alking barefoot may
result in a misalignment of the prosthetic leg and increase the risk of
falls
oa regular visual check of the foot is recommended. Signs of ear that
may affect function should be reported to a certified professional
odry ith a cloth after any contact ith ater or humidity
othe device 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, a certified professional
should be contacted immediately

7
5- FITTING AND ALIGNMENT INSTRUCTIONS
FITTING HEIGHT
Foot Model Fitting height (cm) Fitting Height (inches)
BioStep CL 15 cm 5-7/8"
BioStep PRO 15 cm 5-7/8"
BioStep XT 18,5 cm 7-5/16"
BioStep EVO 17 cm 6-11/16”
BioStep LP 6,8 cm 2-11/16”
BIOSTEP CL, BIOSTEP PRO, BIOSTEP XT: fitting and alignment instructions
Static alignment
Divide the socket in half.
The midline of the socket should run 25-50 mm anterior
to the midline of the male pyramid ith top of pyramid
parallel to the ground ith 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
sho n.
Dynamic alignment
Adapt the prosthetic alignment adjustments and/or sliding adjustments in order to
ensure correct heel contact, easy roll-over, and optimal shifting of eight onto the
contralateral side. For transtibial amputees please ensure there is physiological knee
flexion during stance phase.

8
BIOSTEP EVO: fitting and alignment instructions
Static alignment
Divide the socket in half.
The midline of the socket should run 25-50 mm
anterior to the midline of the male pyramid ith
top of pyramid parallel to the ground ith 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 sho n.
Dynamic alignment
Adapt the prosthetic alignment adjustments and/or sliding adjustments in order to
ensure correct heel contact, easy roll-over, and optimal shifting of eight 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 ith a heel edge to increase the heel stiffness. To soften the
heel, shorten the edge by cutting along the cut lines. For temporary installation,
secure ith double sided tape. For permanent installation, secure the heel edge ith
Loctite 495 Instant Adhesive (or equivalent).
Green Wedge is prov
ided ith 22
-
27
BioStep EVO
Purple Wedge is provided ith 28-30
BioStep EVO

9
Attention!
Do not force the edge for ard
to ards the bolts or unnecessary
stress ill cause bolts to fail
prematurely.
BIOSTEP LP: fitting and alignment instructions
Static alignment
Measurements from back 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 ith top of pyramid
parallel to the ground ith a 10 mm heel rise; the midline
of the socket ill roughly divide the foot in 1/3 – 2/3.

10
Dynamic alignment
Adapt the prosthetic alignment adjustments and/or sliding adjustments in order to
ensure correct heel contact, easy roll-over, and optimal shifting of eight 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 ith a heel edge to increase the heel stiffness. For temporary
installation, secure ith double sided tape. For permanent installation, secure the heel
edge ith Loctite 495 Instant Adhesive (or equivalent).
Red Wedge (Medium)
Blue Wedge (Firm)
Note: Only install one edge at a time
per patient
Attention!
Do not force the edge for ard
to ards the bolts or unnecessary
stress ill cause bolts to fail
prematurely.
Measurements from back of keel to back of
heel wedge (mm)
Keel size (length) Measurement (mm)
22 - 24 26
25 - 27 43
28 - 30 48

11
6- ASSEMBLY/DISASSEMBLY
Caution: To avoid pinching fingers, al ays use a metal shoehorn.
Doffing (removing) the foot shell
slide the end of the shoehorn behind the foot
push the shoehorn do n and pull the foot out of the footshell
fully remove the spectra sock
replace the spectra sock if orn out
Donning (install) the foot shell
put the spectra sock on the foot
use the end of the shoehorn to position the foot ith the spectra sock 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/do n
the spectra sock must be pulled up to prevent it from interfering ith
moving parts of the foot
7- USAGE
Cleaning and Care
Clean ith a damp cloth and a mild soap. Dry ith a cloth after cleaning
8 - MAINTENANCE
The device and the overall prosthesis must be examined by a certified professional.
Interval should be determined based on patient activity and usage of the device.
We recommend carrying out regular safety checks every 12 months or less.

12
Maintenance includes, but it is not limited to, the follo ing activities:
Remove the foot shell and glide sock, check for damage or ear and replace
if necessary
Clean and check moving parts for signs of damage due to ingress of debris
Check all scre s for tightness
Visually check the heel and toe springs for signs of delamination or ear.
Some surface damage may occur after a period of use, this does not affect
the function or strength of the foot
9 – WARRANTY AND LIABILITY
Warranty terms
ALPS BioStep feet are covered by the follo ing arranty terms against
manufacturing defects:
3 years arranty on the structural/metal elements (carbon fiber elements, bolts and
titanium elements)
6 months arranty on foot shell.
1 month arranty 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 aware that any changes or modifications
carried out on the device which have not been expressly approved will void the
warranty.
Return authorization
To obtain an ALPS Return Authorization Number (RA#) for a arranty call ALPS
Customer Service and provide an ALPS representative ith the follo ing
information:
Customer ID # – Invoice # – Date of Invoice – Nature of Return
The RA# must be displayed on the exterior of the returned item box or it ill be
refused at the dock

13
30 days free return period
ALPS BioStep feet benefit of a 30 days unrestricted return policy for risk-free
comparison and evaluation.
Important notice: Products not returned ithin 30 days are considered sold, ith full
payment due. Return ill be accepted only if the pyramid cover protector has been
used during the installation of the prosthetic leg
Symbol Legend
Manufacturer Medical device Single patient multiple use
Disposal
The device and packaging must be disposed of in accordance ith local or national
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 been classified as a class I device accordingly to the classification rules
outlined in Annex VIII of the regulation.
Reporting of serious incidents
In the unlikely event of a serious incident occurring in relation to this device, it should be
reported to the manufacturer and your national competent authority.

14
ALPS South LLC
2895 42nd Ave. N
St. Petersburg, FL 33714, USA
Tel [phone]
Fax [phone]
[email protected]
.easyliner.com
EC AUTHORIZED
REPRESENTATIVE
CEpartner4U
Esdoornlaan 13
3951DB Maarn
The Netherlands
.cepartner4u.com
UK RESPONSIBLE PERSON
UKCApartner4U
7 Campion Way, Bingham,
Nottingham, NG13 8TR
United Kingdom
.ukcapartner4u.com
EC IMPORTER
ALPS CZECH ENGINEERING s.r.o
Božkovské náměstí 17/21
32600 Plzeň – Czech Republic
Tel: [phone]
Fax: [phone]
[e-mail]
.easyliner.eu
4403 02734.3E3 A