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INTRODUCTION
The Soccer Ball Nebulizer Compressor System is a medical device designed to
deliver medicine prescribed by a physician to the airways of the lungs. The Nebulizer
Set and the Air Compressor combined provides aerosol mist for inhalation by the
patient for medical treatment only.
Statement of Indication for Use
The Soccer Ball Nebulizer Compressor is including an AC powered air compressor
that provides a source of compressed air for use with a jet nebulizer in a home health
care setting. The compressor provides a maximum flow rate of 8 Lpm that can be
connected to is used in conjunction with a jet (pneumatic) nebulizer with the same
performance specifications to convert certain inhalable drugs into an aerosol
form for inhalation by a patient. The patient population is determined by the
nebulizer to which it is connected.
The disposable nebulizer cup is used to administer various aerosol treatments to adult and
pediatric patients in both the homecare and healthcare settings. Its use is indicated
whenever a physician or healthcare professional administers or prescribes medical aerosol
products to a patient using a Small Volume Nebulizer. The disposable nebulizer cup is
disposable, single-patient-use and intended for use with pediatric (5 years and older) and
adult patient.
The Reusable Jet Nebulizer is a handheld, pneumatic nebulizer designed to aerosolize
prescription drugs for inhalation by a patient. Its use is indicated whenever a healthcare
professional administers or prescribes medical aerosol products to a patient using a small
volume nebulizer. The Reusable Jet Nebulizer is intended for use with pediatric (2 years
and older) and as defined by the prescribed medication and adult patients in hospital/
institutional settings, home care use, schools, and long term care facilities.
IEC SYMBOLS
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