fillauer ProCover Orthotics and Prosthetics Manufacturer Instruction Manual

: June 13, 2024
: fillauer

Table of Contents

fillauer ProCover Orthotics and Prosthetics Manufacturer
Product Information
Product Usage Instructions
Intended Use
Warranty
Included Components
Warnings and Precautions
Specifications and Preparations
Disposal
Contact
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fillauer ProCover Orthotics and Prosthetics Manufacturer

Product Information

The Fillauer ProCover is a durable and resilient polyurethane foam cover designed to enhance performance and protect the foot module. Its split design allows for easy installation and removal, making maintenance and cleaning a breeze. The ProCover is intended for use with the AllPro, AllPro PM, or Wave Comfort 3 prosthetic feet.

Warnings

CAUTION: If the foot shell and ProCover are submerged, they should be rinsed with fresh water and dried immediately to remove salt, chlorine, or debris.
CAUTION: To protect the foot shell and ensure its maximum performance, socks and shoes should be worn at all times. After exposure to water, socks and shoes should be allowed to fully dry to prevent damage to the shell.
CAUTION: The foot shell should be inspected daily for signs of cracks, holes, and the presence of sand or debris. If any issues are detected, the foot shell should be replaced promptly to prevent damage to the carbon fiber and soling materials. If debris is present, rinsing and drying are recommended.
CAUTION: The foot shell can be cleaned using a soft cloth and a soap and water solution or rubbing alcohol (70%). Acetone should not be used as it can damage the foot shell.

Qualified Provider

Attachment, adjustment, alignment, and delivery of this device should be performed by or under the direct supervision of a qualified prosthetist. Any activities not stated in this manual should not be attempted by the user as they may potentially void the device warranty.

Product Usage Instructions

To install the ProCover:

Insert the foot into one side of the ProCover, pressing down firmly to fully seat the foot in the internal cavity.
Align the four connector pins and press firmly to place the other side of the cover. There may be a slight gap between the two halves, but this can be minimized by firmly squeezing them together.
The ProCover can be easily removed for cleaning purposes, ensuring the foot remains in good working order.

Compatibility: The ProCover is compatible with the adult AllPro DM, AllPro PM, AllPro XTS, and Wave Comfort prosthetic feet. It is recommended to use a Fillauer spectra sock with this device. The fit of feet from other manufacturers cannot be guaranteed.

Intended Use

The Fillauer ProCover is made of durable and resilient polyurethane foam that enhances performance and protects the foot module. The split design makes the cover easy to install and remove for ease of maintenance and cleaning. The ProCover is intended for use with the AllPro, AllPro PM, or Wave Comfort 3.

Performance Characteristics

SkiTrek

Compatible feet: AllPro, AllPro PM, AllPro XTS, Wave Comfort 3
Sizes: 22 – 30 cm
Weight (26 cm): 9.1 oz. (259 g)
Material: Polyurethane foam
Activity level: K3 – K4

Storage and Handling

It is recommended that the ProCover is stored in a cool, clean, dry environment away from harsh chemicals (chlorine, acids, acetone, etc.).

Warranty

The ProCover is warrantied for 6 months from date of installation.
Warranty is voided by alteration, misuse of product, or failure to comply with instructions.

Included Components

Replacement Components

Size: Component Replacement Kit

Includes 4 Connector Pins and 2 Velcro® Straps

22 – 25/ 182-10-2300
26 – 30/ 182-10-2350

Warnings and Precautions

CAUTION: The foot shell is waterproof to 1 meter. However, if it is submerged, the foot and ProCover should be rinsed with fresh water and dried immediately to remove salt, chlorine, or debris.
CAUTION: The foot shell is designed to provide maximum performance of the foot. The life of the foot shell will depend on level of activity and degree to which it is protected from wear and damage with socks and shoes. Socks and shoes should be worn at all times and should be allowed to dry fully after exposure to water to prevent damage to the shell.
CAUTION: Patients should inspect the foot shell daily for signs of cracks or holes and for the presence of sand or other debris. If the foot shell shows signs of failure, it should be replaced as soon as possible to prevent damage to the carbon fiber and soling materials. If debris is present, the foot and shell should be rinsed and allowed too fully dry.
CAUTION: The foot shell may also be cleaned with a soft cloth and a soap and water solution or with rubbing alcohol (70%). Do not use acetone. It will damage the foot shell.

Qualified Provider

Attachment, adjustment, alignment, and delivery of this device must be performed by or under the direct supervision of a qualified prosthetist. Unless stated in this manual, any such activities should not be attempted by the user and will potentially void the device warranty.

Specifications and Preparations

Specifications and Preparations Before Use (Risk Management for Installation and Calibration)

Attention: Deviating from the installation instructions or modifying the ProCover in any way will void any product warranty and could lead to product failure and injury to the patient.

ProCover Installation

Insert the foot into one side of the ProCover and press down firmly so the foot is fully seated in the internal cavity.
Install the other side by aligning the four connector pins and pressing firmly in to place. It is normal to have a slight gap between the two halves but this can be minimized by firmly squeezing the two sides together.
Install the two Velcro® straps by tightly wrapping them around the toe and heel channels with the soft sides of the straps facing out.
The cover can be easily removed to aid cleaning the foot and keep the foot in good working order.

Compatibility

The ProCover is appropriate for use with the adult AllPro DM, AllPro PM, AllPro XTS, Wave Comfort prosthetic feet. A Fillauer spectra sock should be used with this device. The fit of other manufacturers feet cannot be guaranteed.

Disposal

Disposal / Waste Handling

The product must be disposed of in accordance with applicable local laws and regulations. If the product has been exposed to bacteria or other infectious agents, it must be disposed of in accordance with applicable laws and regulations for the handling of contaminated material.