uniprox F120 Chopart User manual

Karbon-Füße
F120 Chopart
F125 Chopart Plus
F130 Symes-Tech Plus
F140 Pars 3
F150 Synergy® 3 LP
F160 Synergy® 3
Carbon-Feet
F120 Chopart
F125 Chopart Plus
F130 Symes-Tech Plus
F140 Pars X3
F150 Synergy® X3 P
F160 Synergy® X3
unique prosthetic solutions
A company of the Bauerfeind GroupEin Unternehmen der Bauerfeind Gruppe – www.uniprox.de
GA_F1 0-F160_Rev.0- 0 -04
Qualität und Funktion
Gebrauchsanweisung
Instruction Manual
Distributed by:
Uniprox GmbH & Co.KG, H.-Heine-Str.4, 07937 Zeulenroda-Triebes
ORTOTEK A.Ş.
Ziya Gökalp Cad. 68/ 1
Kolej/Ankara/TÜRKEI

3
Please read the IFU carefully before fitting. Only correct usage will
warrant the function.
1. Intended Use
The carbon prosthetic foot is the basis for the modular design of a leg prosthesis.
2. Technical Data
The carbon prosthetic feet were developed primarily for the needs of active users. They
are suitable for walking on various surfaces. The carbon foot modules consist of a
composite carbon fiber component, a Spectra™ sock and a foot shell. Rubber buffer to
increase the stiffness of the heel for Symes-Tech Plus, Pars X3, Synergy® X3 LP,
Synergy® X3.
Size: – 9
Patient body weight limit: 147 kg
Heel Height: 10 mm
Foot Cover Skin Tones: Caucasian
Patient Mobility levels: - 4 (Synergy® X3 LP, Pars X3, Symes-Tech Plus,
Synergy® X3)
1 - 4 (Chopart, Chopart Plus)
X = Side: 1 = left = right
Y = Hardness Category
ZZ = Size
Order No. Product Name Installation
Height
Attachment
Type Article No.
F1 0-[Size][Side][Cat.] Chopart approx. 9 mm
without footshell / 46031100X0Y0ZZ
F1 5-[Size][Side][Cat.] Chopart Plus approx. 10 mm
without footshell M36 46031 00X0Y0ZZ
F130-[Size][Side][Cat.] Symes-Tech
Plus
- 5 = 38 mm
6 - 9 = 40 mm M36 46031300X0Y0ZZ
F140-[Size][Side][Cat.] Pars X3 - 5 = 63 mm
6 - 9 = 66 mm Male Pyramid 46031400X0Y0ZZ
F150-[Size][Side][Cat.] Synergy® X3 LP - 5 = 115 mm
6 - 9 = 1 5 mm Male Pyramid 46031500X0Y0ZZ
F160-[Size][Side][Cat.] Synergy® X3 - 5 = 155 mm
6 - 9 = 165 mm Male Pyramid 46031600X0Y0ZZ
2.1 Foot category selection table
To identify the applicable activity level, use the activity table.
Impact level
Weight(kg) Activity Level
Low Medium High
45 - 5 1 1
53 - 59 1 3
60 - 68 3 4
69 - 77 3 4 5
78 - 88 4 5 6
89 - 100 5 6 7
101 - 116 6 7 8
117 - 130 7 8 9
131 - 147 8 9
Activity Level
Low Medium High
Hobby-Oriented-Athlete Recreational Athlete Extreme Athlete
Walking Hiking Baseball
Biking Jogging Competitive Sports
Bowling Martial Arts Football
Camping Skating Power Lifting
Dancing Skateboarding Running
Fishing Skiing Snowboarding
Gardening Tennis Soccer
Golfing Volleyball Wakeboarding
Surfing Boxing

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2.2 Service parts
2.2.1 Foot Shell
X = Side: 1 = Left = Right
ZZ = Size
2.2.2 Spectra™ Socks
3. Indication/ Contraindication
Indication:
•Lower limb amputation
Contraindication:
•Not known
4. Side effects
There are no known side effects.
Order No. Size Side Article No.
E-F1 0-[Size][Side] - 9 Right/ Left 4 603 119 0X 00 0ZZ
Order No. Product name Foot Article No.
E-F1 0-SS1 Spectra-Sock short Pars X3, Symes-Tech Plus,
Chopart, Chopart Plus 4 603 119 00 01 000
E-F1 0-SS Spectra-Sock long Synergy® X3 LP, Synergy® X3 4 603 119 00 0 000
5. General Instructions
•This medical product is designed for single patient, multiple use.
•Fitting/ service of this medical device is only allowed by a certificated orthopedic
professional.
•The professional should instruct the correct use of the device to the user.
•If there is any visible damage, stop using the product.
•Do not hesitate by considering the repair and maintenance periods specified for
the product.
•If there is mechanical damage to the product, check its function, or contact the
manufacturer or Uniprox.
•For the highest possible safety and the longest possible service life, the
recommended assembly and usage procedures must be followed.
•Do not expose the product to unacceptable environmental conditions such as
mechanical shock or impact, dust, sand, excessive amounts of water, sweat, urine,
fresh water, salt water or acids.
•Improper modification or use of the product is not permitted. Failure to do so may
impair the function of the product, exposing the patient to risk and voiding the
warranty.
•Improper modification or application to the product is not allowed. In case of
nonobservance, the function of the product may be impaired, so that product
liability is excluded.
6. Installation
6.1 Before installing the prosthesis
•Plantarflex / Dorsiflex foot to fit shoe heel height.
•Adduct / Abduct socket to provide proper front plane angle.
•Flex or extend the socket to ensure proper sagittal plane angle.

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- English -
6.4 Dynamic Alignment
The impact energy is stored in the heel spring (except Chopart and Chopart Plus),
which thus supports the rolling motion. This movement helps the main spring to store
energy and release it in toe-off.
•To optimize the rolling motion from the heel to the foot, set the following
variables:
•Placement of the foot in A-P
•Dorsiflexion/ plantarflexion
•Heel stiffness
6.4.1 Error search and troubleshooting
Problem Indications Solutions
If the heel is very soft
•The foot comes forward only
with difficulty
•The toe feels extremely stiff
•Move the socket forward in relation
to the foot
•Insert heel buffer to reinforce the
heel spring
If the heel is very hard
•Rapid knee flexion, instability
•Feed from the heel to the toes
•Feeling of lack of energy
returns
•Move the socket backward in relation
to the foot
•Select foot-category lower
If the foot module too
hard
•Flat point in rollover
movement in slow cadences •Select foot-category lower
If the foot module too
soft
•Noise at initial contact
•Extreme foot deflection with
high effective activity
•Select foot-category higher
6.2 Installation Chopart
Position the socket on the sole plate as shown in the illustration, ensuring proper
plantar/dorsal flexion and external rotation. The rear third of the Chopart plate must
be degreased and roughened before bonding. Fix the sole plate in the rear third with
suitable epoxy or PU-adhesive for the try-on. Fill the space between the socket and
sole plate in the area of the rear third with adhesive. For the final finish, the
connection between the socket and the Chopart plate must be covered with a sufficient
amount of reinforcing material in the area of the rear third.
Pic. 1: Static structure Chopart
6.3 Installation Symes-Tech Plus, Pars 3, Synergy 3 LP and Synergy 3
Move the socket linearly to ensure that the weight line runs along the front edge of the
adapter (Pic. )
Pic. : Static structure (Example: Symes-Tech Plus and Synergy X3)
/3 1/3
Abb. 1
Pic. 1
Pic.

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7. Maintenance and Cleaning
7.1 Maintenance
The foot should be checked after the first 30 days of use. In addition, we recommend
an annual check.
Spectra™ socks should be changed at intervals appropriate to the user's activity level.
Failure to inspect and replace Spectra™ socks may damage foot shells and void the
warranty.
7.2 Cleaning
•Compressed air up to bar
•Soap and lukewarm water
•Do not use aggressive solvents
8. CE-Conformity
The product satisfies the requirements of Regulation (EU) 017/745 of the European
Parliament and of the Council (MDR) and bears the CE mark. All major incidents related
to the product needs to be informed to Uniprox and/or Ortotek as well as to the
competence European Authority.
9. Warranty and Guarantee
Warranty is provided under the terms of sale and supply of Uniprox GmbH & Co. KG
provided that the above conditions are met. A 3-year warranty is provided on material
and manufacturing defects and a 6-month warranty is provided on foot shell.
10. Disposal
This product has no special storage regulations.
The product is disposable with standard household garbage.
Please direct any questions to:
Customer Service: + 49 (0) 366 8-66-33 70
Fax: + 49 (0) 366 8-66-33 77
E-mail: [email protected]