ottobock 1C58 Taleo Side Flex Instruction Manual

1C58 Taleo Side Flex
Instructions for use

1C58 Taleo Side Flex

Product description

INFORMATION
Date of last update: 2021-09-09

• Please read this document carefully before using the product and observe the safety notices.
• Instruct the user in the safe use of the product.
• Please contact the manufacturer if you have questions about the product or in case of problems.
• Report each serious incident related to the product to the manufacturer and to the relevant authority in your country. This is particularly import­ ant when there is a decline in the health state.
• Please keep this document for your records.

1.1 Construction and Function
The 1C58 Taleo side flex prosthetic foot adapts to uneven surfaces and enables full-surface ground contact even when the foot is not set down straight. It has an m-l (medial-lateral) unit with a titanium torsion bar spring that allows the foot to tilt sideways (inversion and eversion) by up to 10°. Additional bumpers gently dampen the stop during this process. Thanks to this flexibility, tilting moments and lateral pressure forces on the residual limb are considerably reduced. This results in stabilization, improved com­ fort, and more natural adaptation to the ground. The heel strike is absorbed by the large, replaceable heel wedge. Carbon and polymer spring elements permit perceptible plantar flexion at heel strike, a natural rollover movement, and high energy return.

1.2 Combination possibilities
This prosthetic component is compatible with Ottobock’s system of modular connectors. Functionality with components of other manufacturers that have compatible modular connectors has not been tested.
Prohibited combination possibilities

• 4R88

Limited combination options for Ottobock components
The prosthetic foot generates high moments in the ankle area. Use structural components with higher weight limits:

Body weight [kg]| 88 to 100| Up to
115| Up to
130
---|---|---|---
Foot size [cm]| From 27| 30| From 29| From 26
Structural component weight limit
[kg]| ≥125| ≥150| ≥150| ≥150

Intended use

2.1 Indications for use
The product is intended exclusively for lower limb endoprosthetic fittings.
2.2 Area of application
Our components perform optimally when paired with appropriate compon­ ents based upon weight and mobility grades identifiable by our MOBIS clas­ sification information and which have appropriate modular connectors.

The product is recommended for mobility grade 3 (unrestricted outdoor walker) and mobility grade 4 (unrestricted outdoor walk­ er with particularly high demands).
The table that follows shows the suitable spring stiffness of the prosthetic foot, matching the patient’s body weight and activity.

Spring stiffness relative to body weight and activity level

Body weight [kg]| Normal activity
level| High activity level
up to 51| 1| 2
52 to 58| 2| 3
59 to 67| 3| 4
68 to 77| 4| 5
78 to 88| 5| 6
89 to 100| 6| 7
101 to 115| 7| 8
116 to 130| 8| –

2.3 Environmental conditions

Allowable environmental conditions
Temperature range: –10 °C to +45 °C (14 °F to 113 °F)
Chemicals/liquids: fresh water, salt water, perspiration, urine, soapsuds, chlorine water
Moisture: Submersion: max. 1 h in 3 m depth, relative humidity: no restrictions
Solids: Dust, occasional contact with sand
Clean the product after contact with humidity/chemicals/solids, in order to avoid increased wear and damage (see page 22).

Unallowable environmental conditions
Solids: Highly hygroscopic particles (e.g. talcum), continuous contact with sand
Chemicals/liquids: Acids, continuous use in liquid media
Storage and transport
Temperature range –20 °C to +60 °C (–4 °F to +140 °F), relative humidity 20 % to 90 %, no mechanical vibrations or impacts

2.4 Lifetime
Prosthetic foot
Depending on the patient’s activity level, the maximum lifetime of the product is 3 years.
Foot shell, protective sock
The product is a worn part, which means it is subject to normal wear and tears.

Safety

3.1 Explanation of warning symbols

CAUTION Warning regarding possible risks of accident or injury.
NOTICE Warning regarding possible technical damage.

3.2 General safety instructions

CAUTION!

Risk of injury and risk of product damage

• Note the combination possibilities/combination exclusions in the instruc­ tions for use of the products.
• Comply with the product’s field of application and do not expose it to excessive strain (see page 15).
• To avoid the risk of injury and product damage, do not use the product beyond the tested lifetime.
• To avoid the risk of injury and product damage, only use the product for a single patient.
• To prevent mechanical damage, use caution when working with the product.
• If you suspect the product is damaged, check it for proper function and readiness for use.
• Do not use the product if its functionality is restricted. Take suitable measures (e.g. cleaning, repair, replacement, inspection by the manu­ facturer or a specialist workshop).

NOTICE!

Risk of product damage and limited functionality

• Check the product for damage and readiness for use prior to each use.
• Do not use the product if its functionality is restricted. Take suitable measures (e.g. cleaning, repair, replacement, inspection by the manu­ factor or a specialist workshop).
• Do not expose the product to prohibited environmental conditions.
• Check the product for damage if it has been exposed to prohibited envir­ mental conditions.
• Do not use the product if it is damaged or in questionable condition.
  Take suitable measures (e.g. cleaning, repair, replacement, inspection by the manufacturer or a specialist workshop).

Signs of changes in or loss of functionality during use
Reduced spring effect (e.g. decreased forefoot resistance or changed rollover behavior) or delamination of the spring are indications of loss of functionality. Unusual noises can indicate a loss of functionality.

Scope of delivery

Additional accessories/spare parts (not included in the scope of delivery)

Designation| Reference number
Foot shell| 2C15
Connection cover| 2C19, 2C20*

Preparing the product for use

CAUTION
Incorrect alignment, assembly, or adjustment
Injury due to incorrectly installed or adjusted as well as damaged prosthet­ ic components

• Observe the alignment, assembly, and adjustment instructions.

NOTICE

Grinding the prosthetic foot or foot shell
Premature wear resulting from damage to the product

•  Do not grind the prosthetic foot or foot shell.

5.1 Alignment

INFORMATION
There is a plastic protector on the product’s pyramid. It protects the con­ necting section from scratches during the alignment and fitting of the pros­ thesis.

•  Remove the protector before the patient leaves the workshop/fitting area.

INFORMATION
The resistance of the m-l unit is permanently set and cannot be changed. Do not remove the cover from the m-l unit.

5.1.1 Applying/removing the foot shell

INFORMATION

• Pull the protective sock over the prosthetic foot to prevent noises in the foot shell.
• Always use the prosthetic foot with the foot shell.
• Apply or remove the foot shell as described in the foot shell instructions for use.

5.1.2 Bench Alignment
INFORMATION
Exterior foot rotation should not exceed 5°. Otherwise, the inversion/ever­ sion of the prosthetic foot could influence the rollover behavior and the frontal knee stability in the stance phase.

TT bench alignment

Bench alignment process

Required materials: 662M4 goniometer, 743S12 heel height measuring apparatus, 743A80 50:50 gauge, alignment apparatus (e.g. 743L200 L.A.S.A.R. Assembly or 743A200 PROS.A. Assembly)
Assemble and align the prosthetic components in the alignment apparatus according to the following specifications:
1| Heel height: effective heel height (shoe heel height – sole thickness of forefoot) + 5 mm
2| Sagittal alignment: alignment reference line on a—p markings of the foot shell (see fig. 5)
3| Frontal alignment: alignment reference line on m—I markings of the foot shell (see fig. 5)
4| Connect the prosthetic foot and prosthetic socket using the selected adapters. Follow the adapter instructions for use.
5| Sagittal alignment: Determine the center of the prosthetic socket with the 50:50 gauge. Align the prosthetic socket centrally to the alignment refer­ ence line.
Socket flexion: individual residual limb flexion + 5°
6| Observe the abduction or adduction position.
---|---

TF bench alignment

• Observe the information in the prosthetic knee joint instructions for use.

5.1.3 Static Alignment

INFORMATION
The frontal plane, hip-width stance: Align the prosthesis so that the m-l unit is in the neutral position (see fig. 6). Thus the entire available movement range can be used for inversion and eversion.

• Ottobock recommends checking the alignment of the prosthesis using the L.A.S.A.R. Posture and adapting it as needed.
• If necessary, the alignment recommendations (TF modular leg pros­ theses: 646F219, TT modular leg prostheses: 646F336) may be requested from Ottobock.

5.1.4 Dynamic Trial Fitting

• Adapt the alignment of the prosthesis in the frontal plane and the sagittal plane (e.g. by making angle or slide adjustments) to ensure an optimum gait pattern.
• TT fittings: Make sure that physiological knee movement in the sagittal and frontal plane is achieved when the leg begins to bear weight after the heel strike. Avoid medial movement of the knee joint. If the knee joint moves in the medial direction in the first half of the stance phase, move the prosthetic foot in the medial direction. If the medial movement occurs in the second half of the stance phase, reduce the exterior rotation of the prosthetic foot.
• Remove the plastic protector from the pyramid after completing the dynamic fitting and the walking exercises.

5.1.4.1 Optimising the heel characteristics
The behavior of the prosthetic foot at heel strike and during heel contact in the mid-stance phase can be adapted by replacing the heel wedge. Heel wedges of various hardness are included in the scope of delivery.
Heel wedge hardness: The color of the heel wedge indicates the hard­ ness (see fig. 4). Ottobock recommends starting with the preinstalled heel wedge.

1. Pull the prosthetic foot apart slightly and remove the existing heel wedge.
2. Align the other heel wedge so the Ottobock lettering is the right way up and the tip points to the anterior.
3. Insert the heel wedge into the prosthetic foot (see fig. 2).

5.2 Optional: Installing the foam cover

The foam cover sits between the prosthetic socket and the prosthetic foot. It is cut longer in order to compensate for the movements of the prosthetic foot and prosthetic knee joint. During flexion of the prosthetic knee joint, the foam cover undergoes posterior compression and anterior elongation. The foam cover should be stretched as little as possible in order to increase its service life. There is a connecting element (such as a connection plate, connection cap or connection cover) on the prosthetic foot.

Required materials: degreasing cleaner (e.g. 634A58 isopropyl alco­ hol), 636N9 contact adhesive, or 636W17 plastic adhesive

1. Measure the length of the foam cover on the prosthesis and add the length allowance.
   TT prostheses: Distal allowance for movement of the prosthetic foot.
   TF prostheses: Allowance proximal of the knee rotation point for flexion of the prosthetic knee joint and distal allowance for movement of the prosthetic foot.

2. Cut the pre-shaped foam cover to length and fit it in the proximal area of the prosthetic socket.

3. Pull the foam cover over the prosthesis.

4. Set the connecting element onto the foot shell or prosthetic foot. Depend­ ing on the version, the connecting element engages in the edge or rests on the foot adapter.

5. Install the prosthetic foot on the prosthesis.

6. Mark the outer contour of the connecting element on the distal face of the foam cover.

7. Disassemble the prosthetic foot and remove the connecting element.

8. Clean the connecting element using a degreasing cleaner.

9. Glue the connecting element onto the distal face of the foam cover according to the marked outer contour.

10. Let the glue dry (approx. 10 minutes).

11. Install the prosthetic foot and adapt the exterior cosmetic shape. Take into account compression caused by cosmetic stockings or SuperSkin.

Cleaning

Allowable cleaning agent: pH neutral soap (e.g. 453H10 Derma Clean)

1. NOTICE! To avoid product damage, only use the allowable clean­ ing agents.
   Clean the product with clear fresh water and a pH neutral soap.

2. If present: Remove dirt from water drainage contours using a toothpick and rinse.

3. Rinse the soap away with clear fresh water. In doing so, rinse the foot­ shell until all dirt has been removed.

4. Dry the product with a soft cloth.

5. Allow to air dry in order to remove residual moisture.

Maintenance

• A visual inspection and functional test of the prosthetic components should be performed after the first 30 days of use.
• Inspect the entire prosthesis for wear during normal consultations.
• Conduct annual safety inspections.

Disposal

In some jurisdictions it is not permissible to dispose of the product with unsorted household waste. Improper disposal can be harmful to health and the environment. Observe the information provided by the responsible authorities in your country regarding return, collection, and disposal proced­ ures.

Legal information

All legal conditions are subject to the respective national laws of the country of use and may vary accordingly.
9.1 Liability
The manufacturer will only assume liability if the product is used in accord­ ance with the descriptions and instructions provided in this document. The manufacturer will not assume liability for damage caused by disregarding the information in this document, particularly due to improper use or unauthor­ ised modification of the product.

9.2 CE conformity
The product meets the requirements of Regulation (EU) 2017/745 on medic­ all devices. The CE declaration of conformity can be downloaded from the manufacturer’s website.

Technical data

1058 Taleo Side Flex

Sizes [cm]| 22| 23| 24| 25| 26 I| 27| 28| 29| 30
With slim foot shell| Heel height [mm]| 15 ± 5| –
System height [mm]| 58| 59| 62| 62| –
Build height [mm]| 76| 77| 80| 80| –
Weight [g]| 640| 670| 720| 760| –
With normal foot shell| Heel height [mm]| –| 10 ± 5
System height [mm]| –| 67| 67| 67| 72| 72| 77| 77
Build height [mm]| –| 85| 85| 85| 90| 90| 95| 95
Weight [g]| –| 740| 780| 790| 810| 850| 900| 940
Max. body weight [kg]| 88| 100| 115| 130
Mobility grade| 3.

………………………………………

Ottobock SE & Co. KGaA
Max-Näder-Straße 15
· 37115 Duderstadt · Germany
T +49 5527 848-0 ·
F +49 5527 848-3360
healthcare@ottobock.de·
www.ottobock.com

Otto Bock HealthCare LP
3820 West Great Lakes Drive
Salt Lake City, UT 84120 · USA
T +1 800 328 4058
F +1 800 655 4963
© Ottobock · 647G1679=all_INT-04-2109

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