college park Odyssey K2 Prosthetic Foot Device Instructions
- June 12, 2024
- college park
Table of Contents
- Odyssey K2 Prosthetic Foot Device
- Package Contents
- Tools Recommended
- Key Components (Figure 1)
- PRODUCT DESCRIPTION
- INDICATIONS:
- CONTRAINDICATIONS:
- PROTECTIVE COVER ON DOME
- TECHNICAL SPECIFICATIONS
- GAIT MATCHING®GUIDELINES
- MOUNTING
- ASSEMBLY AND DISASSEMBLY (for sock replacement)
- ADDITIONAL CONSIDERATIONS
- Read User Manual Online (PDF format)
- Download This Manual (PDF format)
technical instructions
Odyssey K2 Prosthetic Foot Device
Package Contents
(1) OdysseyK2 Foot
(1) Foot Shell
(1) CPI Sock
Tools Recommended
(1) 3mm Hex Key
(1) 4mm Hex Key
(1) Foot Horn
This diagram is to help familiarize you with the unique parts of the Odyssey K2. These parts are referenced in the instructions and used when speaking with a technical service representative.
Key Components (Figure 1)
A. Integrated Pyramid
C. Fulcrum Pad
E. Heel Wedge (permanent)
• CPI Sock (not shown)
B. Ankle-Housing Assembly
D. Toe Spring
F. Heel Spring
• Foot Shell (not shown)
PRODUCT DESCRIPTION
This prosthetic foot device is constructed with an integrated pyramid,
housing, two composite springs, and heel wedge. The toe spring is secured to
the housing and heel spring with fasteners.
INTENDED USE
The Odyssey K2 is a prosthetic foot designed to replace one or more functions
of the biologic human foot.
INDICATIONS:
- Lower limb amputations
CONTRAINDICATIONS:
- None known
PROTECTIVE COVER ON DOME
Remove the protective cover on dome after alignment is completed and before patient leaves clinic.
TECHNICAL SPECIFICATIONS
FOOT SIZE | WEIGHT LIMIT | BUILD HEIGHT | **FOOT WEIGHT*** |
---|---|---|---|
21-24 cm | 220 lbs / 100 kg | 3.1 in / 7.8 cm | 744 g |
25-30 cm | 300 lbs / 136 kg | 3.3 in / 8.4 cm |
*26cm foot w/shell
GAIT MATCHING®GUIDELINES
The gait match determines the firmness of the foot based on the user’s
specifications (foot size, patient weight, and impact level).
FIRMNESS CATEGORIES
Refer to the chart below to determine the correct firmness category.
Note: Incorrect category selection may result in poor device function.
Contact College Park Technical Service if you have questions about category
selection.
WEIGHT LBS | 0-140 | 141-180 | 181-220 | 221-300 |
---|---|---|---|---|
WEIGHT KG | 0-63 | 64-81 | 82-100 | 101-136 |
SIZE CM | 21-30 | 25-30 | ||
LOW IMPACT | 1 | 2 | 3 | 4 |
MOUNTING
Use only high quality endoskeletal components.
ASSEMBLY AND DISASSEMBLY (for sock replacement)
Use the FootHorn to don and doff the foot shell. Remove the CPI Sock and
replace as needed. Any further disassembly or modification of components will
void the warranty.
HYDRAULIC RANGE (Figure 2)
The Odyssey K2 foot has 12º of hydraulic motion. The foot is designed to
provide 1º hydraulic dorsiflexion from the neutral standing position. This is
intended to prevent midstance drift; the sensation of user instability
(lacking toe support) during standing.
The foot was developed utilizing a flexible composite base. As a result, a
typical user will experience an additional range of dynamic motion during
ambulation.
Note: Excessive angular adjustment will affect the hydraulic range of the
foot. After making an alignment change, ensure that the user retains 1º of
hydraulic dorsiflexion.
STATIC ALIGNMENT (Figure 3)
For optimal function, balance the patient’s weight evenly between the heel and
toe.
- The Odyssey K2 was designed with a 3/8” (10 mm) heel rise.
- The load line divides the foot at 1/3 heel lever and 2/3 toe lever.
Using a 3mm hex key for adjustment, the hydraulic valves should be set at
minimum resistance. Have the user stand comfortably and evaluate the heel-toe
balance of the foot.
They will sense the hydraulic movement of the ankle but should not feel like
they are falling forward or backward.
Use alignment to position the foot at the point where they feel the most
balanced.
SYMPTOM | ALIGNMENT CHANGE |
---|---|
Falling Backward | Shift foot posterior relative to the socket |
Falling Forward | Shift foot anterior relative to the socket |
DYNAMIC ADJUSTMENTS (Figure 4)
Have the user begin by walking on level ground, to evaluate the heel-toe
resistance and gait timing. Using a 3mm hex key, adjust for planterflexion
resistance first, then dorsiflexion.
Finalize dynamic alignment by observing the user walking on an inclining-
declining surface (ramp). Make further adjustments to the resistance valves as
necessary.
- Anterior (Figure 4A)
Dorsiflexion resistance affects the user’s gait through Midstance, as the body
travels over the foot.
Planterflexion resistance affects the user’s gait from Heel Strike to Foot
Flat.
DESIRED RESULT | VALVE ADJUSTMENT |
---|---|
Firmer Planterflexion | Turn P-valve clockwise (more resistance) |
Softer Planterflexion | Turn P-valve counterclockwise (less resistance) |
Firmer Dorsiflexion | Turn D-valve clockwise (more resistance) |
Softer Dorsiflexion | Turn D-valve counterclockwise (less resistance) |
ADDITIONAL CONSIDERATIONS
Have the user practice standing up from a seated position in order to acclimate to the motion of the ankle. Use caution when driving. Make sure the user is comfortable with the motion of the ankle if using the Odyssey K2 as their driving foot.
WARNING
- Do not expose this product to corrosive materials, salt water or pH extremes.
- Contaminants such as dirt and the use of lubricants or powder may effect the function of the CPI Sock and lead to noise.
- Failure to follow these technical instructions or use of this product outside the scope of its Limited Warranty may result in injury to the patient or damage to the product.
RESIDUAL RISK STATEMENT
NOTICE OF RESIDUAL RISK
During fitting process, ensure that CPI sock does not become pinched between
foot and endoskeletal componentry.
WARRANTY INSPECTION / MAINTENANCE INFORMATION
College Park recommends that you schedule your patients for check-ups
according to the warranty inspection schedule below.
High patient weight and/or impact level may require more frequent inspections.
We recommend you visually inspect the following applicable parts for excessive
wear and fatigue at each warranty inspection.
- Hydraulic Assembly
- Composites and Adapters
- CPI Sock
- Foot Shell
WARRANTY INSPECTION SCHEDULE FOR ODYSSEY K2 : 6 MONTHS, THEN ANNUALLY.
TECHNICAL ASSISTANCE / EMERGENCY SERVICE 24-7-365
College Park’s regular office hours are Monday through Friday, 8:30 am – 5:30
pm (EST). After hours, an emergency Technical Service number is available to
contact a College Park representative.
LIABILITY
The manufacturer is not liable for damage caused by component combinations
that were not authorized by the manufacturer
CAUTION
College Park products and components are designed and tested according to the
applicable official standards or an in-house defined standard when no official
standard applies. Compatibility and compliance with these standards are
achieved only when College Park products are used with other recommended
College Park components. This product has been designed and tested based on
single patient usage. This device should NOT be used by multiple patients.
CAUTION
If any problems occur with the use of this product, immediately contact your
medical professional. The prosthetist and/or patient should report any serious
incident that has occurred in relation to the device to College Park
Industries, Inc. and the competent authority of the Member State in which the
prosthetist and/or patient is established.
‘Serious incident’ is defined as any incident that directly or indirectly led, may have led, or might lead to any of the following; (a) the death of a patient, user, or other person, (b) the temporary or permanent serious deterioration of a patient’s, user’s, or other person’s state of health, (c) a serious public health threat.
The OdysseyK2 is covered by the following patents:
USA: Patent US 8,926,711
800.728.7950 |
586.294.7950 | college-park.comOdysseyK2 :
COMPONENTES DE ÓRTESES E PRÓTESES EXTERNAS
ANVISA Registro : 80117580371
IMPORTADOR: EMERGO BRAZIL IMPORT
IMPORTAÇÃO DE PRODUTOS MÉDICOS
HOSPITALARES LTDA. AVENIDA
Francisco Matarazzo, 1.752, Salas 502/503,
Agua Branca, Sao Paulo-SP, CEP – 05001-200
MADE IN THE USA
©2022 College Park Industries, Inc. All rights reserved.
430 INS OK2 TIS 220519
COLLEGE PARK INDUSTRIES, INC
27955 College Park Dr. Warren, MI 48088 USA
EMERGO EUROPE
Prinsessegracht 20, 2514 AP The Hague, Netherlands
Australian Sponsor
EMERGO AUSTRALIA
Level 20, Tower II, Darling Park, 201 Sussex Street,
Sydney, NSW 2000 Australia
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