Information for Prescribers,
The Vest® System, Model 104
The Vest® Airway Clearance System, Model 104
About The Vest® System
The Vest® System is an easy-to-use Airway Clearance Device for both children and adults. It was originally introduced in 1988. The device consists of an inflatable vest connected by two Air Hoses to a small Air Pulse Generator. It is quiet and easy to transport, enabling people to receive effective airway clearance therapy at home, work, or on the road.
How does The Vest® System work?
The Air Pulse Generator rapidly inflates and deflates the inflatable vest, gently compressing and releasing the chest wall up to 20 times per second. This process, called High Frequency Chest Wall Oscillation (HFCWO), creates mini-coughs that dislodge mucus from the bronchial walls, increase mobilization, and move it along toward central airways. The action also works to thin thick secretions, making them easier to clear. Once the mucus has moved from the smaller to larger airways, it can be easily removed by coughing or suctioning.
Treatments are easy
Most users manage therapy without any help. Unlike manual chest percussion therapy (CPT), The Vest® System does not require special positioning or breathing techniques. The technology is technique-independent. A typical treatment takes 15-20 minutes.
HFCWO has been widely described in medical literature. More than 80 studies in more than 60 facilities - spanning 20 years of research - demonstrate the efficacy and safety of HFCWO for a variety of patients.
The Vest® System is widely accepted and:
- Prescribed to treat secretion-related pulmonary complications in more than 575 diseases and conditions, including muscular dystrophy, spinal cord injury, chronic obstructive pulmonary disease (COPD), multiple sclerosis (MS), cerebral palsy (CP) and cystic fibrosis (CF).
- Prescribed for more than 70,000 people with airway clearance needs.
- Prescribed by more than 12,000 physicians nationwide.
- Being used to maintain healthy lung function in post-operative, ICU and post-lung transplantation patients.
- Approved for payment by more than 900 commercial insurance companies and 250 government-funded payers.
The following conditions are indications for use of The Vest® System:
1.Documented need for airway clearance as defined by the American Association for Respiratory Care (AARC)1 clinical practice guidelines. These guidelines include:
a.Evidence of difficulty with secretion clearance
Difficulty clearing secretions with expectorated sputum production greater than 25 - 30 ml/day (adult).
Evidence or suggestion of retained secretions in the presence of an artificial airway.
b.Presence of atelectasis caused by or suspected of being caused by mucus plugging.
c.Diagnosis of disease such as cystic fibrosis, bronchiectasis, or cavitating lung disease.
2.Need for sputum sample for diagnostic evaluation.
Individualization of Treatment
Each patient should be evaluated individually by his/her physician to determine the safety and appropriateness of therapy or use of The Vest® System for sputum induction.
Hill-Rom has not developed specific protocols for use of The Vest® System in individual patients or specific patient populations.
Commonly prescribed protocols for use of The Vest® System are available from Hill-Rom.
Therapy by The Vest® System may be administered in the home. Hill-Rom provides both training and support for home use of The Vest® System.
Conformance to Standards
The FDA has designated The Vest® System as a class II device, but no FDA standards have been established under Section 514.
The Vest® System complies with:
- UL 544, Standard for Safety for Medical and Dental Equipment
- C22.2, Canadian Standard for Electromedical Equipment
- The electromagnetic compatibility requirements defined in FCC Part 15 and European Standard EN 55011.
How The Vest® System is Supplied
- The Vest® System is available from Hill-Rom
- The air-pulse generator comes fully assembled
- The system includes the air-pulse generator, a vest, connecting tubing, power cord, and a remote control
- All equipment and accessories are non-sterile
Diseases and Conditions with Airway Clearance Needs
The Vest® System is used for airway clearance associated with over 575 diagnoses. Information on diseases and conditions that may require Airway Clearance Therapy:
Useful Airway Clearance Therapy decision-making criteria include: