terrain Foot Ankle Prosthetics Instruction Manual

technical instructions

PACKAGE CONTENTS

(1) Terrain foot
(1) Foot Shell
(1) CPI Sock
(1) Horizon Wedge Kit

TOOLS REQUIRED
4mm Hex Key
TOOLS RECOMMENDED
(1) Foot Horn
This diagram (Figure 1) is to help familiarize you with the unique parts of the Terrain. These parts are referenced in the instructions and used when speaking with a technical service representative.
Key Components, FOOT (Figure 1)

A. Integrated Pyramid
B. Ankle-Housing Assembly
C. Toe Spring
D. Nut Plate
E. Heel Spring
F. Permanent Wedge
G. Rounded Heel Wedge (optional)
• CPI Sock (not shown)
• Foot Shell (not shown)

PRODUCT DESCRIPTION

This prosthetic foot device is constructed with an integrated pyramid, ankle- housing assembly, two composite springs, and heel wedge. The toe spring is secured to the housing and heel spring with fasteners.

INTENDED USE

The Terrain 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.

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.
ENDOSKELETAL MOUNTING
Use only high quality proximal endoskeletal components.
STATIC ALIGNMENT
For optimal function, balance the patient’s weight evenly between the heel and toe. (Figure 2)

• The Terrain was designed with a 3/8” (10.0 mm) heel rise.
•  The load line divides the foot at 1/3 heel lever and 2/3 toe lever.

DYNAMIC ADJUSTMENTS

heel wedge
Softer Heel Response| Plantarflex the Terrain or move load line posterior| Remove heel wedge

*To install or remove heel wedge, refer to the Horizon Wedge Kit Instructions.
WARNINGS

WARNING

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

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. 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.

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

WARRANTY INSPECTION SCHEDULE FOR THE TERRAIN: 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 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.
NOTES

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