ottobock 1C68 Triton side flex Instruction Manual

ottobock 1C68 Triton side flex Instruction Manual

ottobock 1C68 Triton side flex

1 Product description

INFORMATION

Date of last update: 2022-01-24

►   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 1C68 Triton 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 unit (medial-lateral) with a titanium torsion bar spring that allows the foot to tilt sideways (inversion and eversion) by up to 10°. Additional buffers gently dampen the stop. Much lower moments of tilt and lateral compression forces are transferred to the residual limb thanks to this flexibility. This results in stabilisation, improved comfort and more natural adaptation to the ground.
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]| up to

55

| up to 75| up to 100| up to

125

---|---|---|---|---
Foot size [cm]| up to 26| up to 28| from 29| up to 28| from 29| up to 30
Structural component weight limit [kg]| ≥75| ≥100| ≥125| ≥125| ≥150| ≥150

2 Intended use

2.1 Indications for use

The product is intended exclusively for lower limb exoprosthetic fittings.

2.2 Area of application

Our components perform optimally when paired with appropriate compo­ nents based upon weight and mobility grades identifiable by our MOBIS classification 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 the size of the prosthetic foot.

Spring stiffness

Body weight [kg]| Foot size [cm]
22| 23| 24| 25| 26| 27| 28| 29| 30
up to 55| 1| −
56 to 75| 2
76 to 100| 3
101 to 125| −| 4

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 21 ).
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

The product was tested by the manufacturer with 2 million load cycles. Depending on the user’s activity level, this corresponds to a maximum life­ time of 3 years.

Footshell, protective sock

The product is a wear part, which means it is subject to normal wear and tear

3 Safety

3.1 Explanation of warning symbols

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

3.2 General safety instructions

Risk of injury and risk of product damage

• Note the combination possibilities/combination exclusions in the instruc­ tions for use of the products.

Risk of injury and risk of product damage

► Note the combination possibilities/combination exclusions in the instructions 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 manufacturer or a specialist workshop).

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 manufacturer 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 environmental conditions.
► Do not use the product if it is damaged or in a 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 behaviour) or delamination of the spring are indications of loss of
functionality. Unusual noises can indicate a loss of functionality.

4 Scope of delivery

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

Designation| Reference number
Footshell| 2C6
Connection cap| 2C19, 2C20*
Protective sock (white)| SL=Spectra-Sock

5 Preparing the product for use

CAUTION

Incorrect alignment, assembly or adjustment Injury due to incorrectly installed or adjusted as well as damaged prosthetic components
► Observe the alignment, assembly and adjustment instructions.

NOTICE

Grinding the prosthetic foot or footshell Premature wear resulting from damage to the product
► Do not grind the prosthetic foot or footshell.

5.1 Alignment

INFORMATION

There is a plastic protector on the product’s pyramid. It protects the connecting section from scratches during the alignment and fitting of the prosthesis.
► 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 footshell

INFORMATION

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

5.1.2 Bench Alignment

bench alignment

Bench alignment process

Required materials: 662M4 goniometer, 743S12 heel height measuring device,

743A80 50:50 gauge, alignment tool (e. g. 743L200 L.A.S.A.R. Assembly or 743A200 PROS.A. Assembly)

Perform the assembly and alignment of the prosthetic components in the alignment tool according to the following specifications:
Sagittal plane
| Heel height: Effective heel height (shoe heel height – sole thickness of fore­

foot) + 5 mm

| Exterior foot rotation should not exceed 5°. Otherwise the inversion/eversion

of the prosthetic foot could influence the rollover behaviour and the frontal knee stability in the stance phase.

| a–p positioning, middle of the prosthetic foot to the alignment reference line:
Foot size [cm]:| Anterior placement, middle of foot to align­ ment reference line [mm]:
22 to 25| 25
26 to 28| 30
29 to 30| 35
| Connect the prosthetic foot and prosthetic socket to the chosen adapters. The instructions for use of the adapters must be observed.
| Determine the centre of the prosthetic socket with the 50:50 gauge. Align the prosthetic socket centrally to the alignment reference line.

Socket flexion: individual residual limb flexion + 5°

Frontal plane
| Alignment reference line of prosthetic foot: between big toe and second

toe

Alignment reference line of prosthetic socket: along the lateral patella

edge

| 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

Frontal plane, hip width stance: Align the prosthesis so that the m-l unit is in the neutral position (see fig. 2). 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 prostheses: 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 heel characteristics are optimised by using heel wedges. In case the heel strike or heel contact is too soft during the mid-stance phase, the heel can be stiffened by means of a heel wedge.
Two heel wedges are available (transparent=soft, black=hard). Ottobock recommends starting with the transparent heel wedge.

1. Align the recesses in the heel wedge, in the proximal and posterior directions.
2. Slide the heel wedge into position between the attachment spring and heel spring until it engages (see fig. 3).
3. To remove the heel wedge, push it out to the side.

5.2 Optional: Installing the foam cover

The foam cover sits between the prosthetic socket and 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 alcohol), 636N9 contact adhesive or 636W17 plastic adhesive

1. Measure the length of the foam cover on the prosthesis and add the ength 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 on the prosthetic socket.

3. Pull the foam cover over the prosthesis.

4. Set the connecting element onto the footshell or prosthetic foot. Depending 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 Super Skin.

6 Cleaning

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

1. NOTICE! To avoid product damage, only use the allowable cleaning 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 footshell 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.

7 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.

8 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 procedures

9 Legal information

All legal conditions are subject to the respective national laws of the country of use and may vary accordingly.

The manu

9.1 Liability

facturer will only assume liability if the product is used in accordance 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 unauthorised modification of the product.

9.2 CE conformity

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

10 Technical data

1C68 Triton side flex

Sizes [cm]| 22| 23| 24| 25| 26| 27| 28| 29| 30
With slim footshell| Heel height [mm]| 15 ± 5| −
System height [mm]| 57| 57| 58| 63| 63| 68| −
Build height [mm]| 75| 75| 76| 81| 81| 86|
1C68 Triton side flex

Sizes [cm]| 22| 23| 24| 25| 26| 27| 28| 29| 30
With slim footshell| Weight [g]| 620| 690| 720| 770| 785| 835| −
With normal footshell| Heel height [mm]| −| 10 ± 5
System height [mm]| −| 64| 66| 68| 72| 72| 75| 78
Build height [mm]| −| 82| 84| 86| 90| 90| 93| 96
Weight [g]| −| 730| 780| 805| 845| 870| 990| 10­

25

Max. body weight [kg]| 100| 125
Mobility grade| 3 and 4

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