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LimbAir™ Product Overview

Thank you for your interest in LimbAir™. Please contact Fabtech Systems for additional information and support.

Purpose

Purpose

LimbAir™ provides a simple means to adjust socket volume and applied pressure in response to changes in limb volume or intended activity level.

 

  • For those that experience routine daily limb volume changes, the system enables positive or negative volume compensation through manual inflation or deflation of an internal air bladder.
     

  • Adjustments are made without removal of the prosthesis and can easily be done in a tactile manner through clothing. 
     

  • Given the ease to discretely release pressure beneath clothing, the system allows amputees to maximize time at low pressure when a tight fit is not required in order to facilitate comfort and general limb health.
     

  • Additionally, the system is beneficial to highly active individuals that require a secure fit while engaged in dynamic activities requiring maximum coupling between the limb and prosthesis.
     

  • For many users the system eliminates the need to carry additional socks as the range of volume compensation is equivalent to ~5-7 sock plies.
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  • The ultimate goal is to improve amputee comfort, health and quality of life resulting in a reduction office visits and medical expenses.

Patent Pending

Features

Key Features

  • Efficient pressure adjustment beneath clothing - The purpose-built custom pump optimizes stroke force and direction to allow simple adjustment in seconds without need to remove the prosthesis to add sock plies.
     

  • Tactile bleed valve allows regulated pressure reduction - The high-reliability precision valve allows minor fine tuning or complete relaxation discretely by feel alone.
     

  • Low profile and low weight  - The system is constructed of machined aluminum and high durability polymers for a nearly imperceptible (170g) weight for the complete system. In many cases it provides a net weight reduction given elimination of additional sock plies.
     

  • Robust pressure sealing with high strength bladder and precision components - It is a critical design criteria to realize a pneumatic system that can be relied upon to not leak. This is achieved through use of high quality materials, minimization of interfaces an use of precision components.
     

  • Bladder shape optimized for wrinkle-free install in most sockets - The spade shape was evolved from extensive testing on a range of patients having a variety of limb sizes and shapes. The supplied bladder was selected as a most-likely fit for most patients. Alternate sizes and custom shapes will be available in the future.
     

  • Bladder material facilitates longevity and consistent feel - The bladder material is highly robust to puncture and abrasion as well as rigid to in-plane stretching yet flexible to bending. By eliminating the stretch, the pressure and volume relationship is maintained for a consistent feel.
     

  • Bladder design allows for temporary installation to locate ideal placement - As described in more detail below, the neck shape of the bladder allows it to be temporarily routed over the lip of the socket to allow test fitting for patient comfort before making any permanent modifications to the prosthesis.
     

  • Durable construction with flexible mounting to easily adapt to any socket - The primary mounting bracket can be deformed as needed to fit most socket shapes. Mounting hardware is provided and minor modifications to implement a permanent mount can typically be done within a single standard office visit.
     

  • Direct "tube free" mounting or alternate remote mount options - Using the direct mount method, the pump assembly interfaces directly to the bladder without need for any exposed tubing. Nevertheless, materials are included to allow a remote mount where the pump mechanism can be physically separated from the bladder.
     

  • Suggested HCPCS Reimbursement Code - L5646

Operation

Operation

Increasing pressure is achieved by displacing the lever upward repeatedly until the desired fit is achieved. 

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Pressure is reduced by depressing the bleed button. Bleed rate is increased as the button is depressed further. Press partially for controlled reduction or press fully for quick complete relaxation.

Note: While the pump can be mounted in any orientation, it is desirable to mount as shown with the pumping action being from bottom to top. This is so because clothing most often can be compressed (bunched) in this direction, whereas clothing is in tension if pumped from top to bottom, therefore creating difficulty.

Notes & Safety

Notes & Safety

The LimbAir™ system is intended to be robust to environments typically observed with prosthetics, however the following considerations should be made:
 

  • At temperatures approaching freezing or below, the pump actuation may become slow or cease to function. The system will maintain inflation and can be bled in this environment. If expecting to be used in very cold conditions, it is recommended that adjustments be made prior to cold environment exposure.
     

  • The system incorporates an air filter to limit intrusion of particulate matter that may degrade pump performance. Usage in highly dirty or dusty environments may require this filter to be replaced within the expected useful life of the system. A service kit will be made available.
     

  • The primary attachment hardware should be checked during routine visits to ensure that it remains fastened tightly. The use of thread locker is strongly recommended.
     

  • The system is built of durable materials that are intended to perform under typical daily usage conditions, such
    as: regular actuation, minor contact with objects, doffed prosthesis falling over, etc.  Nevertheless, it cannot be guaranteed to survive all possible impact loads. It is recommended to review the placement and particular impact risks with each individual.
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The LimbAir™ system is intended to facilitate limb health by enabling the user to maximize time at low pressure and only apply higher pressure when tight coupling is needed. It is important that this aspect is reviewed with the user and that they fully understand the features and operation of the system. Some key safety provisions are as follows:
 

  • The system is capable to add the max equivalent volume of approximately 5-7 sock plies. Users should be informed to manage volume compensation similar to how they would previously using sock plies.
     

  • The prosthetist should monitor initial usage and general limb health to ensure only similar or positive outcomes compared to traditional volume compensation methods.
     

  • The bladders are self limiting in maximum displacement and are capable to resist pressures many times greater than the maximum applied pressure by the pump or expected dynamic loads from activity.
     

  • The pump is self limiting and therefore continued pumping will only reach a maximum pressure that is far below the safe limit for the bladder and other pressure interfaces.
     

  • In the event of damage or other circumstance where pressure is lost or unable to be added, the user is able to resume volume compensation using traditional methods until repairs can be made.
     

  • In the highly unlikely event of a malfunction in the pressure release function, the mounting screws can be removed and the pump physically separated from the bladder to allow depressurization.
     

Feedback regarding this information or the product in general is welcomed at: inquiry@epochmedical.com. 

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