Introduction

Thank you for buying the VibraVM™ Acoustic Airway Clearance Percussor. This Veterinary medical device is the product of many years of research and development. The resultant performance, reliability and safety of the Device may provide significant health benefits to the animals treated.

This manual is written in such a way as to provide a clear understanding of the features, operation, maintenance and expected medical benefits associated with the use of the VibraVM™ Acoustic Percussor. For additional information and updates, please consult our website at www.VibraVM.com.

Limitations of Liability

The VibraVM™ is a medical device for use in animals. As with any medical device, you as the operator are encouraged to seek professional medical advice from your veterinary regarding its use in treating any specific disease.

This manual contains information about the Company’s product and certain medical conditions where treatment with the product may prove beneficial. Every patient and every disease state is somewhat unique, naturally giving rise to certain risks and uncertainties. While having been shown to be safe in every case to date, the results of any treatment or series of treatments may differ materially from those anticipated. In addition, there are many factors that can influence patient outcome that are unrelated to treatment with the VibraVM™ Acoustic Percussor. As such, the operator assumes full liability and responsibility for patient outcomes. While every effort has been made to create an accurate Operating Manual, the Company makes no representations or warranties as to the accuracy of the information in
this manual, and undertakes no obligation to update publicly any of the contents of this Operating Manual, even if new information becomes available or other events occur in the future. Also see the Limited One-Year Warranty section of this manual.

Limitations of Use

THIS DEVICE IS NOT FOR HUMAN USE. It is specifically designed and programmed for the treatment of lung and airway disease in animals.

Safety

A number of important safety features have been engineered into your VibraVM™ Acoustic Airway Clearance Device:

• The Device will not operate with the Battery Charger attached to prevent accidental electric shock.

• Rechargeable environmentally friendly Nickel Metal Hydride (NiMH) batteries power the Device.

• The battery pack contains a self-resetting fuse that opens in the event of electrical current overload.

• The disposable Nose Piece tips are made of a soft elastomer plastic reducing the possibility of nasal trauma.

• The disposable Diaphragms are designed to protect the inside of the Device Body from fluid and bacterial contamination while still allowing for the transfer of sound waves generated by the Device.

• The disposable Bio-Bags protect the outside of the Device Body from fluid and bacterial contamination, and receive disposable components after treatment.

• The Device operates at sound frequencies found on a standard piano keyboard and at a decibel sound pressure level below that of a human singing voice.

Nasal/Oral High Frequency Oscillation

The VibraVM™ Acoustic Airway Clearance Device generates sound waves which are directed through the airway to the lungs to liquefy and dislodge mucus and other secretions in the lungs for expulsion. This is referred to as Nasal/Oral High Frequency Oscillation, or Acoustic Chest Physiotherapy (ACPT).

Indications for Use

Use of the VibraVM™ Acoustic Airway Clearance Device is indicated for the clearance of mucus in the lungs and airways of animals with obstructive and phlegm producing conditions such as COPD (including persistent coughing, hay dust intolerance, summer pasture associated COPD, bronchitis, asthma, heaves, and emphysema), pneumonia, influenza, sinusitis and other such conditions.

It is designed to help loosen and dislodge mucus from an animal’s airways so it can be expelled more easily providing better lung function and associated benefits.

Further, there is empirical evidence to suggest a relaxation of constricted bronchial airways with treatments in “Massage” mode.

Contra-indications for Use

• Use of the VibraVM™ Acoustic Airway Clearance Device is contra-indicated in the presence of pneumothorax.

• The animal should be generally stable before initiating respiratory therapy. Professional clinical judgment is necessary in cases involving life threatening airway obstruction.

Mechanism of Action

The VibraVM™ Acoustic Percussor works by vibrating airways and the mucus lodged in various bronchial tubes causing the mucus to liquefy and break away. The approach uses sound waves to deliver energy to mucus plugs and bronchi in the lungs. The point where mucus and lung contact each other is called a boundary. At this boundary there is adhesion that can be broken. Mucus is of a different size and density than lung tissue. This difference in size and density results in different physical characteristics. Energy delivered to the affected area in the form of sound waves at the correct frequency will cause tissues and mucus to independently move or vibrate. The rates at which these structures and their contents naturally vibrate are called their resonant frequencies.

If the sound waves are the same frequency as the resonant frequency of the mucus, it will vibrate very easily and continuously while the bronchial tubes will stay somewhat stationary because they have a different resonant frequency. Likewise, as the bronchi vibrate at their resonant frequency, the associated mucus will tend to remain stable. In both instances, a shear force is created between the bronchial tube and mucus causing the adhesive bond to fail. The mucus is thus dislodged, liquefied and expelled by natural mechanisms.

Because mucus varies in density, mass, and location, and because the various bronchial sections vary in size, density and mass, the device is set to deliver a range of frequencies. As the protocol progresses, the induced sound waves will, at different times, match the resonant frequencies of bronchial tubes or mucus plugs causing each to independently vibrate giving the desired result.

In “Massage mode”, a range of frequencies are broadcast simultaneously producing “white noise”. This provides a second means of delivering acoustic percussion over a wider range of frequencies to resonate the bronchi and mucus plugs while gently massaging and potentially relaxing airway passages.

Why Airway Clearance is Important

Animals with congestion or hypersecretory lung conditions accumulate secretions which harbor bacteria, inflammatory cells, and inflammatory mediators resulting in recurring infections, and inflammation. Research suggests that removing the medium  (phlegm or mucus) in which the disease proliferates, is an effective way of reducing the recurrence of infections and the progression of lung disease.