college park L5979 Tribute Foot Instructions

technical instructions

L5979 Tribute Foot

Package Contents

(1) Tribute Foot
(1) Foot Shell
(1) CPI Sock
(1)Cosmetic Attachment Plate (regular toe only)
(1) TruLube Lubricant

Tools Recommended

(1) 4 mm Hex Key
(1) Foot Horn
(1) 6 mm Hex Key
(1) Pin Guide
This diagram is to help familiarize you with the unique parts of the Tribute. These parts are referenced in the instructions and used when speaking with a technical service representative.

Key Components (Figure 1)

A. Endo Ankle Bone
B. Foreheel Bone
C. Bumpers (2)
D. Axial Pin
E. Ankle Bushings (2)
F. Axial Pin Screw Torque 4 N·m (36 in·lbs)
G. Stride Control ® Adjustment
• CPI Sock (not shown)
• Foot Shell (not shown)

PRODUCT DESCRIPTION

This prosthetic foot device is constructed with an endo ankle bone, composite foreheel, bumpers, bushings, axial pin, and screw. The foreheel is secured to the ankle bone with the axial pin and screw.

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.

GAIT MATCH CHART

Components may be changed as needed. Determine the user’s firmness category, then refer to the chart below for the recommended components.
For gait match adjustments, see section: Dynamic Adjustments.

FIRMNESS CATEGORY

*Color Code: (S) Soft = Yellow, (M) Medium = Red, (F) Firm = Blue
MOUNTING\
Use only high quality proximal endoskeletal components.

ASSEMBLY AND DISASSEMBLY

1. Use the Foot Horn to don and doff the foot shell. Remove the CPI Sock and replace as needed.

2. Use a 4 mm hex key to reduce the preload on the bumpers by turning the Stride Control adjuster counterclockwise.
   Record the number of turns for use in re-assembly.

3. Use a 6 mm and 4 mm hex keys to remove the axial pin screw.

4. Attach the pin guide to the axial pin. Push and rotate clockwise.

5. Unscrew the axial pin from the pin guide and remove it from the ankle bone.

6. Remove the ankle bone from the foreheel to access the front and rear bumpers and ankle bushings.

7. For re-assembly, lubricate the axial pin, inside and outside of the ankle bushings and ankle bushing pocket, then reverse steps 1-4. Torque axial pin screw to 4 N·m (36 in·lbs).

DO NOT LUBRICATE FRONT AND REAR BUMPERS.
STATIC ALIGNMENT (Figure 2)
For optimal function, balance the patient’s weight evenly between the heel and toe.

• The Tribute 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.

STRIDE CONTROL ADJUSTMENT
The adjustable Stride Control gives you the ability to customize an individual’s gait timing, fine-tuning the foot’s response by either turning it clockwise/ counterclockwise. This adjustment affects both plantar and dorsiflexion resistance without the need to change soft components.
The Tribute ships with a medium Stride Control setting. If new bumpers are fitted, set the preload to 2-turns (medium preload) from the point of initial contact with the ankle bone.
If an additional 1-1/2 turns are required to attain the desired resistance, then a change in bumpers is recommended.

DYNAMIC ADJUSTMENTS

Increase Stride Control Front Bumper up one step firmer
Softer Toe Response| Dorsiflex the Tribute or move load line anterior| Decrease Stride Control Front Bumper down one step softer
Firmer Heel Response| Dorsiflex the Tribute or move load line anterior| Increase Stride Control Rear Bumper up one step firmer
Softer Heel Response| Plantarflex the Tribute or move load line posterior| Decrease Stride Control Rear Bumper down one step softer

**WARNING**

• Do not expose this product to corrosive materials, salt water or pH extremes.
• 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.
• Any further disassembly or modification of components will void the warranty.

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 on the Tribute foot six months after initial fitting and then annually.
High patient weight and/or impact level may require more frequent inspections. Soft component wear depends on the patient weight, impact level and environment. We recommend you inspect the following applicable parts for excessive wear and fatigue at each warranty inspection and replace as needed.

• Soft components (disassemble, inspect & re-lubricate)
• Composites and Adapters
• CPI Sock
• Foot Shell

WARRANTY INSPECTION SCHEDULE FOR TRIBUTE: 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.

800.728.7950 | 586.294.7950 | college-park.com
The Tribute is covered by the following registered
design and design patent:
China: ZL201630194073.9
Tribute:
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.
180 INS TB TIS 220519
COLLEGE PARK INDUSTRIES, INC
27955 College Park Dr. Warren, MI 48088 USA
EMERGO EUROPE
rinsessegracht 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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