college park Odyssey K2 Prosthetic Foot Device Instructions

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

*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.

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.

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.

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
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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
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Prinsessegracht 20, 2514 AP The Hague, Netherlands
Australian Sponsor
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Level 20, Tower II, Darling Park, 201 Sussex Street,
Sydney, NSW 2000 Australia

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