Ossur PRO-FLEX XC User manual

Instructions for Use
PROFLEX®XC

FIGURES 
EN | Instructions for Use 
DE | Gebrauchsanweisung 
FR | Notice d’utilisation 
ES | Instrucciones para el uso 
IT | Istruzioni per l’uso 
NO | Bruksanvisning 
DA | Brugsanvisning 
SV | Bruksanvisning 
EL | Οδηγίε Χρήση 
FI | Käyttöohjeet 
NL | Gebruiksaanwijzing 
PT | Instruções de Utilização 
PL | Instrukcja użytkowania 
CS | Návod k použití 
TR | Kullanım Talimatları 
RU |    
JA | 取扱説明書 
ZH | 中文说明书 
KO | 사용 설명서 

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ENGLISH
Medical Device
DESCRIPTION
The device is a prosthetic foot with integrated male pyramid. It is
composed of a dual and bottom blade secured using heel bolts. The
bottom blade features a sandal toe and a full length composite blade.
The device consists of the following components (Fig. ):
A. Male Pyramid Adapter
B. Pyramid Housing
C. Pyramid Cover
D. Upper C Blade
E. Lower C Blade
F. Bottom Blade
G. Bottom Blade Bolts
H. Drop Toe
The device must be used with a Foot Cover and a Spectra Sock.
INTENDED USE
The device is intended as a part of a prosthetic system that replaces the
foot and ankle function of a missing lower limb.
Suitability of the device for the prosthesis and the patient must be
evaluated by a healthcare professional. The device must be fitted and
adjusted by a healthcare professional.
Indications for Use and Target Patient Population
• Lower limb amputation/deficiency
• No known contraindications
The device is for low to high impact use, e.g., walking and occasional
running.
GENERAL SAFETY INSTRUCTIONS
The healthcare professional should inform the patient about everything
in this document that is required for safe use of this device.
Warning: If there is a change or loss in device functionality, or if the
device shows signs of damage or wear hindering its normal functions,
the patient should stop using the device and contact a healthcare
professional.
The device is for single patient use.
PRODUCT SELECTION
Verify that selected variant of the device is suitable for the impact level
and weight limit according to the following table.
Warning: Do not exceed weight limit. Risk of device failure.
Incorrect category selection may also result in poor device function.

5PB
Weight kg - - - - - - - - - -
Weight lbs - - - - - - - - - -
Low Impact Category
Size -        N/A N/A N/A
Size -          
Size -          
Moderate Impact Category
Size -       N/A N/A N/A N/A
Size -          N/A
Size -          N/A
High Impact Category
Size -      N/A N/A N/A N/A N/A
Size -         N/A N/A
Size -         N/A N/A
ASSEMBLY INSTRUCTIONS
Foot Cover and Spectra Sock (Fig. )
Caution: To avoid pinching fingers, always use a shoehorn.
. Put the foot into the Spectra Sock.
. Remove the foot cover attachment.
. Use the applicable (straight) end of a shoehorn to put the foot with
the Spectra Sock into the Foot Cover.
. Move the shoehorn up to fully push the foot into the Foot Cover.
. Put the foot cover attachment back onto the Foot Cover.
. After alignment is complete, fix the Spectra Sock to the prosthesis to
seal against dust and dirt.
Note: The Spectra Sock must be pulled up to prevent it from interfering
with moving parts of the foot.
If required doff the Foot Cover as follows:
. Remove the foot cover attachment.
. Insert the applicable (edged) end of a shoehorn behind the foot.
. Push the shoehorn down and pull the foot out of the Foot Cover.
. Fully remove the Spectra Sock.
Prosthesis
Assemble prosthesis with applicable devices.
Warning: Ensure proper attachment by following the applicable device
assembly instructions.
Warning: Risk of structural failure. Components from other
manufacturers have not been tested and may cause excessive load on the
device.
Remove the Pyramid Protector during final fitting.
Caution: The Pyramid Protector may have sharp edges.