college park Sidekicks Prosthetic Foot Device Instructions

technical instructions

Sidekicks Prosthetic Foot Device

Package Contents

(1) Sidekicks Foot (individual or pair)
(1) TruLube Lubricant

Tools Recommended

(1) 4 mm Hex Key
(1) 6 mm Hex Key
(1) Pin Guide
This diagram is to help familiarize you with the unique parts of the Sidekicks. 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. Foot Plate
C. Bumpers (2)
D. Axial Pin
E. Ankle Bushings (2)
F. Axial Pin Screw – Torque 4 N·m (36 in·lbs)
G. Stride Control ® Adjustment

PRODUCT DESCRIPTION

This prosthetic foot device is constructed with an endo ankle bone, foot plate, bumpers, bushings, axial pin, and screw. The foot plate is secured to the ankle bone with the axial pin and screw.

INTENDED USE

The Sidekicks 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

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 section: Dynamic Adjustments.

| FIRMNESS CATEGORY
---|---
COMPONENT| 1| 2| 3
FRONT BUMPER| S| M| F
ANKLE BUSHINGS| S| M| F
REAR BUMPER| S| M| F

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

ENDOSKELETAL MOUNTING

Use only high quality proximal endoskeletal components.

ASSEMBLY AND DISASSEMBLY

1. 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.
2. Use a 6 mm and 4 mm hex keys to remove the axial pin screw.
3. Attach the pin guide to the axial pin. Push and rotate clockwise.
4.  Unscrew the axial pin from the pin guide and remove it from the ankle bone.
5.  Remove the ankle bone from the footplate to access the front and rear bumpers and ankle bushings.
6.  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 front and rear bumpers.
STATIC ALIGNMENT (Figure 2)**
For optimal function, balance the patient’s weight evenly between the heel and toe.

• The load line divides the foot at 1/2 heel lever and 1/2 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 Sidekicks ship 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

Increase Stride Control or Front Bumper up one step firmer
Softer Toe Response| Dorsiflex the Sidekicks or move load line anterior| Decrease Stride Control or Front Bumper down one step softer
Firmer Heel Response| Dorsiflex the Sidekicks or move load line anterior| Increase Stride Control or Rear Bumper up one step firmer
Softer Heel Response| Plantarflex the Sidekicks or move load line posterior| Decrease Stride Control or Rear Bumper down one step softer

EXPOSURE TO MOISTURE

Rinse and dry if exposed to salt water or chlorinated water. Exposure to moisture may require more frequent lubrication of the ankle bushings.
WARNING

• 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.

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.

• Soft components (disassemble,inspect & re-lubricate)
• Foot plate tread
• Composites and Adapters

WARRANTY INSPECTION SCHEDULE FOR SIDEKICKS : 6 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……………………….
The Sidekicks is covered by the following design patent:
USA: Patent US D782679
ANVISA Registro : 80117580976
Sidekicks :
Avenida Francisco Matarazzo, 1.752, Salas 502/503,
Agua Branca, São Paulo-SP, CEP – 05001-200
CNPJ: 04.967.408/0001-98
E-mail: brazilvigilance@ul.com
Responsável Técnico: Luiz Levy Cruz Martins,
CRF-SP: 42415
MADE IN THE USA
©2022 College Park Industries, Inc. All rights reserved.

800.728.7950 | 586.294.7950 | college-park.com
481 INS SK TIS 211220
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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