college park Venture Foot Instructions

college park Venture Foot

Package Contents

• (1) Venture Foot
• (1) CPI Sock
• (1) Foot Shell
• (1) TruLube
• (1) Cosmetic Attachment Plate (CAP)

Tools Recommended

• (1) 4 mm Hex Key
• (1) 6 mm Hex Key
• (1) Foot Horn
• (1) Pin Guide

This diagram is to help familiarize you with the unique parts of the Venture. 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 Assembly

• C. Fulcrum Pad

• D. Bumpers (2)

• E. Axial Pin

• F. Ankle Bushings (2)

• G. Axial Pin Screw – Torque 4 N·m (36 in·lbs)

• H. Stride Control® AdjustmentCPI Sock (not shown)

  • Foot Shell (not shown)
    Optional EXO Mount

• I. Exo Pyramid Tool (additional purchase)

• J. Exo Block Kit (additional purchase)

• K. Exo Ankle Bone

• L. Exo Mounting Bolt (included w/exo block kit) Torque 61 N·m (45 ft·lbs)

PRODUCT DESCRIPTION

This prosthetic foot device is constructed with an endo or exo ankle bone option, forehead assembly, bumpers, bushings, axial pins, and fasteners. The forehead is secured with fasteners, and the forehead assembly is secured to the ankle bone with the axial pin and screw.

INTENDED USE
The Venture is a prosthetic foot designed to replace one or more functions of the biological human foot.

INDICATIONS:

• Lower limb amputations

CONTRAINDICATIONS:

• None known

PROTECTIVE COVER ON DOME
Remove the protective cover on the dome after alignment is completed and before the patient leaves the clinic.

TECHNICAL SPECIFICATIONS

FOOT SIZE| WEIGHT LIMIT| MOUNTING| BUILD HEIGHT| **FOOT WEIGHT*
---|---|---|---|---
21-24 cm| 250 lbs / 113 kg| Endo| 2.5 in / 6.4 cm|
Exo| 2.7 in / 6.9 cm| 585 g
25-30 cm| 275 lbs / 125 kg| Endo| 5.0 in / 12.7 cm
Exo| 5.2 in / 13.2 cm|

• 26cm foot w/shell
• low impact only

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 the section: Dynamic Adjustments.

COMPONENT

| FIRMNESS CATEGORY
---|---
1| 2| 3| 4| 5
FRONT BUMPER| S| M| M| M| F
ANKLE BUSHINGS| S| M| M| M| F
REAR BUMPER| S| S| M| F| XF

• Color Code: (S) Soft = Yellow, (M) Medium = Red, (F) Firm = Blue

ENDOSKELETAL MOUNTING
Use only high-quality proximal endoskeletal components.

EXOSKELETAL MOUNTING

1. Remove Exo Ankle Bone, then attach to College Park Exo Block with anti-rotation pin(s) oriented. Apply Loctite® 242 to the mounting bolt. Torque to 61 N·m (45 ft·lbs). To skip alignment and lamination, go to Step 9.
2. If using the alignable Exo option, attach Exo Pyramid Tool to Exo Block with four 6 mm screws. Torque to 15 N·m (11 ft·lbs).
3. Attach 30 mm endo components to the Exo Pyramid Tool and temporarily mount the socket.
4. Re-attach the ankle bone to the foot, donning CPI Sock and foot shell, then perform a dynamic alignment.
5. Remove foot from Exo Block.
6. Mount aligned prosthesis in transfer jig. Lock socket and Exo Block in position.
7. Remove endo components and Exo Pyramid Tool.
8. Use the desired method to span Exo Block to the socket and remove it from the jig. Shape and laminate to desired finish. Do not remove foam from the top of the Exo Block.
9. Re-attach the ankle bone to the forehead. Re-assemble the foot, and don CPI Sock and foot shell.

For growth plate assembly, refer to the Venture Growth Plate Kit Instruction Sheet (included with growth plates).

ASSEMBLY AND DISASSEMBLY

1. Use the Foot Horn to don and doff the foot shell. Remove the CPI Sock and replace it as needed.
2. Use a 4 mm hex key to reduce the preload on the bumpers by turning the Stride Control adjuster counter-clockwise. Record the number of turns for use in re-assembly.
3. Use 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 forehead 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 the front and rear bumpers.

STATIC ALIGNMENT

(Figure 2)
For optimal function, balance the patient’s weight evenly between the heel and toe.

• The Venture 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 Venture 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

Front Bumper up one step firmer

Softer Toe Response| Dorsiflex the Venture or move the load line anterior| Decrease Stride Control

Front Bumper down one step softer

Firmer Heel Response| Dorsiflex the Venture or move the load line anterior| Increase Stride Control

The rear Bumper is up one step firmer

Softer Heel Response| Plantarflex the Venture or move the 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 the fitting process, ensure that the CPI sock does not become pinched between the foot and endoskeletal componentry.

WARRANTY INSPECTION/MAINTENANCE INFORMATION

College Park recommends that you schedule your patients for check-ups on the Venture foot six months after the initial fitting and then annually.

High patient weight and/or impact level may require more frequent inspections. Soft component wear depends on the patient’s 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 VENTURE: SIX 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 another 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.

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.
800.728.7950 | 586.294.7950 | college-park.com.

MADE IN THE USA
©2022 College Park Industries, Inc. All rights reserved.

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