ottobock 17CF1 Ankle Seven Carbon Fiber Spring Instructions
- June 4, 2024
- ottobock
Table of Contents
Instructions
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Foreword INFORMATION
Date of last update: 2021-10-26
► 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 prob lems.
► Report each serious incident in connection with the product, in particular a
worsening of the state of health, to the manufacturer and to the relevant
authority in your country.
► Please keep this document for your records.
These instructions for use provide you with important information on the
processing of the 17CF1 Carbon Ankle Seven.
Product Description
The 17CF1 Carbon Ankle Seven is designed to initiate extension moments of the hip and knee during walking and thus achieve extension and knee stability in the lower limbs. The energy generated during heel strike is stored in the carbon matrix and returned at toe-off. In contrast to con ventional ankle joint orthoses, the limits in the plantar and dorsal direction are dynamic and are not subject to static restriction. Due to its design, the carbon spring has a natural outward foot rotation of 7°.
2.1 Available sizes
Selection of carbon springs according to activity level for AFOs
INFORMATION
Installation of the carbon spring in a KAFO:
Use a weaker carbon spring
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Activity level
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Body weight| Normal activity level| High activity level|
Spring width
up to 100 kg| 17CF1=L/R1| 17CF1=L/R1| 30 mm
up to 90 kg| 17CF1=L/R2| 17CF1=L/R1| 30 mm
up to 80 kg| 17CF1=L/R3| 17CF1=L/R2| 30 mm
up to 70 kg| 17CF1=L/R4| 17CF1=L/R3| 30 mm
up to 60 kg| 17CF1=L/R5| 17CF1=L/R4| 30 mm
up to 50 kg| 17CF1=L/R6| 17CF1=L/R5| 25 mm/30 mm
up to 40 kg| 17CF1=L/R8| 17CF1=L/R7| 25 mm
up to 30 kg| 17CF1=L/R9| 17CF1=L/R8| 25 mm
up to 20 kg| 17CF1=L/R11| 17CF1=L/R10| 22 mm
up to 10 kg| 17CF1=L/R12| 17CF1=L/R11| 22 mm
2.2 Components
Scope of delivery (see fig. 1 )
Item| Quantity| Designation| up to 60 kg| up to 100
kg
1| 1| Carbon spring| |
2| 4| Countersunk head screws| 501S86=M4x12| 501S86=M5x14
3| 4| Countersunk washers| 507U9=M4| 507U9=M5
4| 4| Welding nuts| 502E3=M4x6| 502E3=M5x7.5
5| 1| Template| |
Intended use
3.1 Indications for use
The product is intended solely for orthotic fittings of the lower limbs.
3.2 Indications
- Paralysis or weakness of the dorsiflexor and/or plantar flexor muscles.
Conditions of use
The knee extensor musculature must be functionally intact or exhibit a minimum
residual function (muscle strength 3 to 5 according to Janda), or be secured
with a locked knee joint in a KAFO.
The ankle joint has to exhibit residual mobility of 0-0-15° dorsal extension
according to the neut ral-0 method.
Indications must be determined by the physician.
3.2.1 Contraindications
3.2.1.1 Absolute Contraindications
Not known.
3.2.2 Relative Contraindications
• Structural joint contractures
3.3 Lifetime
The product is designed for the following lifetime when used as intended and
assembled properly:
Body weight up to 40 kg: 1 year
Body weight over 40 kg: 3 years
3.4 Qualification
Patients may be fitted with the product only by trained qualified personnel.
The qualified personnel must be familiar with the handling of the various
techniques, materials, machines, and tools.
Safety
4.1 Explanation of warning symbols
CAUTION Warning regarding possible risks of accident or injury.
NOTICE Warning regarding possible technical damage.
4.2 Safety instructions
CAUTION
Excessive strain on load-bearing components
Injuries due to changes in or loss of functionality
► Only use the product for the defined area of application.
► If the product has been exposed to extreme strain (e.g. due to falling),
take any necessary measures (e.g. repair, replacement, inspection by the
manufacturer’s customer service, etc.).
CAUTION
Mechanical damage to the product
Injuries due to changes in or loss of functionality
► Use caution when working with the product.
► Check the product for proper function and readiness for use.
► In case of changes in or loss of functionality, discontinue use of the
product and have it checked by authorized, qualified personnel.
CAUTION
Incorrect alignment, assembly, or adjustment
Risk of injury due to change in or loss of functionality
► Assembly, adjustment, and maintenance operations may only be completed by
qualified personnel.
► Observe the alignment, assembly, and adjustment instructions.
CAUTION
Excessive strain due to use on more than one patient
Risk of injury and loss of functionality as well as damage to the product
► Use the product on only one patient.
► Observe the maintenance recommendations.
NOTICE
Contact with heat, embers, or fire
Damage to the product due to high temperatures
► Keep the product away from open flames, embers, and other sources of heat.
NOTICE
Thermal overloading of product components
Loss of function due to improper thermal treatment
► Prior to the thermal treatment of the product, remove all temperature-
critical components (e.g. plastic parts).
NOTICE
Exposure of the product to unsuitable environmental conditions
Damage, brittleness, or destruction due to improper handling
► Avoid storage in condensing ambient humidity.
► Avoid contact with abrasive substances (e.g. sand, dust).
► Do not expose the product to temperatures below -10 °C or above +40 °C (e.g.
sauna, excessive sunlight, drying on a radiator).
Preparing product for use
5.1 Processing
NOTICE
Damage due to incorrect processing
Premature wear and tear, loss of functionality due to breakage of the carbon
spring
► Smooth the ground areas with an abrasive flap disc
► Centre the bores in the carbon spring
► Use a suitable counterbore to deburr the boreholes
INFORMATION
Orthosis alignment
Ottobock recommends checking the alignment of the orthosis using the
L.A.S.A.R. Posture or L.A.S.A.R. Posture 3D and adapting it as needed.
Fabricating a plaster model
Due to the design of the carbon spring, make sure the plaster cast is taken
with slight outward rotation. Request the information on the plaster casting
technique if required (Fabricating a plaster cast – KAFO (knee-ankle-foot
orthosis): *646T5411).** Raise the heel slightly by approx. 15 to 20 mm (see
fig. 2) for better positioning of the carbon spring below the foot in the
plaster cast. The enclosed template may be used for the sagittal positioning
of the lower leg (use a small tem plate for sizes 10 to 12).
Installing the carbon spring
Prerequisite: The patient-specific plaster model has been fabricated.
- Pull a layer of Perlon stockinette over the plaster model and fabricate the lining using 5 mm of Pedilin (see fig. 4). The 5 mm material thickness can be used for all size models.
- Mark the fixation zone and movement zone for the carbon spring, dividing the model into zones 1 and 2 (see fig. 3, see fig. 5).
- Mark the carbon spring below the foot, with the length extending up to approx. 20 mm before the rollover zone of the foot (see fig. 6).
- Optional: Shorten the carbon spring, at most up to the mark. Deburr and round the cut edges (see fig. 7).
- Create the structure for the carbon spring on the lining using several layers of Pedilin and sanding (see fig. 8).
- Align the carbon spring in the foot component in the direction of the second foot ray (see fig. 9).
- Contour the Pedilin structure under the carbon spring, avoiding cavities under the carbon spring (see fig. 10).
- Secure the carbon spring on the model with PVA adhesive tape and pull on a layer of Perlon stockinette (see fig. 11).
- For vacuum forming, use homo-polypropylene with a thickness of 4 mm for all carbon spring sizes (see fig. 12).
- Mark the course of the edge and remove the orthosis from the cast. Then separate the calf component from the foot component according to the markings (see fig. 13).
- Use a ruler to mark the center of the bores on the calf component (see fig. 14).
- Mark the bores on the foot component. The proximal bore runs in front of the curve of the heel (see fig. 15).
- For the holes in the orthosis shells, use a 4 mm drill bit for an M4 thread and a 5 mm drill bit for an M5 thread (see fig. 16).
- Transfer the boreholes to the carbon spring (see fig. 17).
- For the 502E3 welding nut, drill a 5 mm hole for an M4 thread and a 6.5 mm hole for an M5 thread (see fig. 18).
- Deburr the bore with a 726S9=90×11.5 counterbore (see fig. 19).
- Press in the welding nut (see fig. 20). To achieve an optimal fit of the bores, screw on the upper section on a trial basis and check the positions of the remaining boreholes. Repeat steps 14 through 16.
- Assemble the carbon spring with the orthosis using the supplied screws, countersunk wash ers, and welding nuts and secure with Loctite 241 (see fig. 21).
- Ottobock recommends positioning the sagittal load line approx. 15 mm in front of the knee compromise pivot point according to Nietert (see fig. 22).
Cleaning
Clean the joint promptly after contact with water containing salt, chlorine, or soap, or if it gets dirty (e.g. sand).
- Rinse the product with clear fresh water.
- Dry the product with a cloth or allow it to air dry. Avoid exposure to direct heat (e.g. from an oven or radiator).
Maintenance
INFORMATION
The product may be exposed to increased loads by the patient.
► Shorten the maintenance intervals according to the expected loads.
The manufacturer requires at least a semi-annual inspection of the product to
verify functionality and check for wear.
Spare parts are listed in the section “Components/design”.
Disposal
Dispose of the product in accordance with national regulations.
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
accordance with the descrip tions 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
unauthorized 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.
****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
© Ottobock · 647G346=all_INT-17-2111