college park Breeze Prosthetic Carbon Foot Instruction Manual

Prosthetic Carbon Foot
Instruction Manual technical instructions

Prosthetic Carbon Foot

Package Contents

(1) Breeze Foot
(1) Foot Shell
(1) CPI Sock
(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 Breeze. These parts are referenced in the instructions and used when speaking with a technical service representative.
Key Components (Figure 1)
A. Integrated Pyramid
B. Housing
C. Foreheel
D. CPI Sock (not shown)
E. Foot Shell
F. Thin Area
G. Fasteners
Drain Hole (Figure 1F)
A thin area is located on the bottom of the EnviroShell®. Create a draining path for water by doffing the footshell and drilling or cutting a 1/4” (6mm) diameter hole in the designated location.

PRODUCT DESCRIPTION:

The prosthetic foot device is constructed with an integrated pyramid, housing, and composite foreheel.
The foreheel is secured to the housing with two fasteners.

INTENDED USE:

The Breeze 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

*25cm foot with shell

FIRMNESS CATEGORIES

The Breeze is available in firmness category 3 only.
Note: Incorrect category selection may result in poor device function.

MOUNTING

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

• The Breeze 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.

Note: Adjustments will need to be made if worn without shoes.

DYNAMIC ADJUSTMENTS

EXPOSURE TO MOISTURE

To maintain the lifespan of the Enviroshell and CPI sock, always dry foot thoroughly after exposure to moisture. Rinse and dry if exposed to salt water or chlorinated water.

COSMETIC FINISHING

College Park does not recommend cosmetically finishing the prosthesis if it will be exposed to moisture.
WARNING

• Under certain circumstances, use in wet environments may increase the risk of slip and fall.
• Remove all shoes and sock and allow to dry in a cool, dry location.
• 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 visuallyinspect the following applicable parts for excessive wear and fatigue at each warranty inspection.

• Composite and Adapter
• CPI Sock
• Foot Shell

WARRANTY INSPECTION SCHEDULE FOR BREEZE: 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
Breeze:
IMPORTADOR: EMERGO BRAZIL
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.
383 INS BE TIS 220519 COLLEGE PARK INDUSTRIES, INC
27955 College Park Dr. Warren, MI 48088 USA
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****Australian Sponsor
EMERGO AUSTRALIA
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Sydney, NSW 2000 Australia

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