Description

The AV Impulse ImPad Foot Cover is an innovative medical device designed to enhance blood circulation in the legs, mimicking the physiological effects of walking. This noninvasive, latex-free pad is intended for single-patient use and is compatible with the A-V Impulse System controller. Its primary function is to aid venous return, reduce edema, and provide prophylaxis against deep vein thrombosis (DVT) and pulmonary embolism.

Key Features

• Compatibility: Designed for seamless integration with the A-V Impulse System controller, including compatibility with the Cardinal Health V-Impulse compression system.
• Size Variability: Available in various sizes to accommodate different shoe sizes, with configurations for left, right, or both feet.
• Design: Features a rigid sole version and an under-cast inflation pad, anatomically shaped to cover the plantar plexus.
• Secure Fit: Equipped with two Velcro hook straps and vent holes for comfort.
• Identification: Right foot cover marked with blue graphics and left with red.
• Hygiene Options: Available in sterile and non-sterile versions, labeled as 'High Level-Disinfected'.

Intended Use

The device is indicated for use in conditions such as:

• Acute and chronic edema
• Leg pain due to trauma or surgery
• Leg ulcers
• Venous stasis/insufficiency
• Lymphedema

Contraindications

Not suitable for patients with conditions where increased fluid to the heart is detrimental, such as congestive heart failure or pre-existing DVT.

Operation

The ImPad Foot Cover is rapidly inflated by a controlled impulse of air from the system controller. It features preset impulse pressure and duration settings, with adjustable impulse pressure between 60–200 mmHg. Safety features include automatic pressure adjustment and alarm indications for faults.

Application Instructions

To use, place the foot centrally on the inflation pad, secure with fastener straps, and connect the tubing to the system controller. Regular monitoring for skin integrity and patient comfort is recommended.

Regulatory Status

Classified as a Class II compressible limb sleeve, the device holds FDA 510(k) clearance and is available by prescription or over-the-counter. It is recommended for use in both hospital and home settings, with usage duration and frequency determined by the prescribing physician.