college park Horizon HD Prosthetic Foot Device Instructions

college park Horizon HD Prosthetic Foot Device

Package Contents

• (1) Horizon HD Foot
• (1) Foot Shell
• (1) CPI Sock
• (1) Horizon Wedge Kit
• (1) Cosmetic Attachment Plate (CAP)

Tools Recommended

• (1) 4mm Hex Key
• (1) Foot Horn

This diagram is to help familiarize you with the unique parts of the Horizon HD. These parts are referenced in the instructions and used when speaking with a technical service representative.

Key Components

• A. Integrated Pyramid
• B. Housing
• C. Toe spring
• D. Heel Spring
• E. Permanent Wedge
• F. Rounded Heel Wedge (Optional)
• G. Nut Plate
• CPI Sock (not shown)
• 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 Horizon HD 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

2.3 in / 5.8 cm

| ****

559 g

26-30 cm| 365 lbs / 165 kg

• 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| 221-275| 276-330| 331-365
---|---|---|---|---|---|---
WEIGHT KG| 0-63| 64-81| 82-100| 101-125| 126-150| 151-166
SIZE CM| 21-30|  |  |  |  | 26-30
LOW-MODERATE IMPACT| 1| 2| 3| 4| 5| 6
HIGH IMPACT| 2| 3| 4| 5| 6| 6

MOUNTING

• Use only high quality proximal endoskeletal components.

ASSEMBLY AND DISASSEMBLY (for sock replacement)

• Use the Foot Horn 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.

STATIC ALIGNMENT

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

• The Horizon HD 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.

DYNAMIC ADJUSTMENTS

None
Softer Toe Response| Dorsiflex the Horizon or move the load line anterior| None
Firmer Heel Response| Dorsiflex the Horizon or move the load line anterior| Install Rounded Heel Wedge
Softer Heel Response| Plantarflex the Horizon or move the load line posterior| Remove Rounded Heel Wedge

• To install or remove toe and heel wedges, refer to the Horizon Wedge Kit Instructions.

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.

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

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.

• Composites and Adapters
• CPI Sock
• Foot Shell
• Heel Wedge (if applied)

WARRANTY INSPECTION SCHEDULE FOR HORIZON HD: 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.

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

HorizonHD

• 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.

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