accent US7862622B2 Dynamic Prosthetic Foot Instruction Manual

US7862622B2 Dynamic Prosthetic Foot
Instruction Manual technical instructions

US7862622B2 Dynamic Prosthetic Foot

Package Contents (IP)
(1) Accent Foot, with Bonded Foot Shell
(1) Ankle Fairing
(1) CA Adhesive
Package Contents (Dp)
(1) Accent Foot, with Bonded Foot Shell
(1) Ankle Fairing
(1) Sleeve Adapter
(1) Pylon Adapter (4-hole, male or female)
(1) DP Cutting Jig
(1) CA Adhesive
Tools Recommended
(1) 4mm Hex Key
This diagram is to help familiarize you with the unique parts of the Accent. These parts are referenced in the instructions and used when speaking with a technical service representative.
Key Components (Figure 1)
A. Ankle Fairing
B. Ankle-Housing Assembly
C. Heel Height Adjustment Button
D. Fulcrum Pad
E. Toe Spring
F. Heel Bumper (not shown)
G. Bonded Foot Shell
DP ONLY
H. Sleeve Adapter
I. Retention Screws (2)
J. Pylon Adapters
K. DP Cutting Jig Tool

PRODUCT DESCRIPTION

This prosthetic foot device is constructed with an integrated pyramid or dynamic pylon option. It includes an ankle-housing assembly with heel height adjustment button, composite toe spring, and heel bumper. The toe spring is secured to the housing with fasteners. The foot shell is bonded to the toe spring and is not removable.

INTENDED USE

The Accent 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

ACCENT IP

*26cm foot w/shell
ACCENT DP

*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.

MOUNTING

Use only high quality proximal endoskeletal components (30 mm). The service- free Accent foot comes permanently assembled in the foot shell. For DP mounting, refer to the Cutting a Dynamic Pylon and DP Sleeve Adapters Tech Tip guides.
HEEL HEIGHT ADJUSTMENT BUTTON
The Heel Height Adjustment Button can be located on the medial or lateral side of the ankle. The Accent foot ships with a medial button placement unless specified by the customer.
HEEL HEIGHT ADJUSTMENT (Figure 2)

1. To adjust heel height, push in and hold the Heel Height Adjustment Button.
2. After the desired heel height is achieved, release the Heel Height Adjustment Button to engage the lock.

Stand and apply a slight pressure to the heel to confirm that the mechanism is firmly seated.
STATIC ALIGNMENT
For optimal function, balance the patient’s weight evenly between the heel and toe.

• The Accent 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.

In order to benefit from the full 2” (51 mm) of heel height adjustment, begin with the foot set in its most dorsiflexed position during initial alignment. This should be done in the lowest desired heel height position (shoe or barefoot), which will allow the widest range of adjustment for increased heel height requirements. Checking of the ideal alignment and function in multiple shoes and heel heights is also recommended.

DYNAMIC ADJUSTMENTS

COSMETICS
The ankle fairing is required for both Dynamic Pylon (DP) and Integrated Pyramid (IP) options, to provide a smooth transition for cosmetic finishing and internal protection from environmental elements. To finish the assembly, refer to the Accent Ankle Fairing / Cosmetic Finishing Instructions (included with the ankle fairing).
WARNING

• Do not expose this product to pH extremes or corrosive materials (water, salt water or other liquids).
• 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.
• Disassembly, modification or removal from the foot shell, or any further disassembly or modification of components will void the warranty.

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 visually inspect the following applicable parts for excessive wear and fatigue at each warranty inspection.

• Composite and Adapter
• Foot Shell

WARRANTY INSPECTION SCHEDULE FOR ACCENT: 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 thesestandards 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.

The Accent is covered by the following patent:
US7862622B2
Accent:
COMPONENTES DE ÓRTESES E PRÓTESES EXTERNAS
ANVISA Registro : 80117580371
IMPORTADOR: EMERGO BRAZIL IMPORT
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.
800.728.7950 | 586.294.7950 | college-park.com
185 INS AC TIS 220519
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

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