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Indications For Use: The O.S.C.A.R. system is intended for use as an ancillary device for the support of whole-body oxygen administration to a patient at greater than ambient atmospheric pressure (hyperbaric oxygen) as prescribed by a physician. It is a device intended to provide control of Pressure Vessels for Human Occupancy without change to their established indications for use. The specific manufacturer's devices intended for use are Environmental Tectonics Corp.'s BARAMED 30" and XD monoplace models. The FDA has cleared the use of hyperbaric chambers under 13 specific medical conditions that are based on the Undersea and Hyperbaric Medicine Society (UHMS)'s indications. These are: - Air or Gas Embolism . - Carbon Monoxide Poisoning and Carbon Monoxide Poisoning complicated by Cyanide Poisoning - Clostridial Myositis and Myonecrosis (Gas Gangrene) - Crush Injury, Compartment Syndrome and other Acute Traumatic Ischemias - Decompression Sickness - Enhancement of Healing in Selected Problem Wounds - Exceptional Blood Loss (Anemia) - Intracranial Abscess - Necrotizing Soft Tissue Infections - Osteomvelitis (Refractory) - Delayed Radiation Injury (Soft Tissue and Bony Necrosis) - Skin Grafts and Flaps (Compromised) - Thermal Burns It is a prescription device that is intended for sale and use by or on the order and under the medical supervision of a physician.

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The BARA-MED Monoplace Hyperbaric Chamber is a prescription device intended for the whole body administration of oxygen to a patient at pressures not exceeding 3 ATA (Atmospheres Absolute).

The BARA-MED® and its predicate devices have the same intended use: as a prescription device intended for the whole-body administration of oxygen to a patient at pressures not exceeding 3 ATA. The BARA-MED® and its predicate devices have very similar general principles of operation. All of these chambers are pressurized and ventilated continuously with purc oxygen, and the patient breathes the chamber atmosphere. Also, in cach of the chambers, the pressure-time profile (i.e. the rate and direction of pressure change and the time hold at any particular pressure), as well as the oxygen ventilation rate of any treatment, are controlled by the chamber's operator, either directly by means of a pneumatic or electronic system, or indirectly by means of an automatic electronic system. The purpose of such controls are to be able to conduct the particular hyperbaric oxygen treatment prescribed by the physician in a way that is sale and comfortable for the patient, and to be able to respond appropriately and effectively to any contingency circumstance. The ETC BARA-MED® is designed and manufactured in accordance with the applicable sections of: ASME Boiler and Pressure Vessel Code, Section VIII, Rules For Construction . of Pressure Vessels, Division 1, 1998 Edition, ASME PVHO-1, Safety Standard For Pressure Vessets For Human . Occupancy, 1997 Edition NFPA 99, Standard For Health Care Facilities, Chapter 19, Hyperbaric . Facilities, 1999 Edition. In all respects, the BARA-MED" is substantially cquivalent to one or more clinical monoplace hyperbaric chambers that are legally marketed for the conduct of hyperbaric oxygen therapy.

All of the contemporary substantially equivalent systems listed in Attachment 12 are used for the same indications as listed in the Hyperbaric Oxygen Therapy: Committee Report, Undersea and Hyperbaric Medical Society, Inc., Revised 1999. - Air or Gas Embolism . - Carbon Monoxide Poisoning and Carbon Monoxide Poisoning complicated by Cyanide . Poisoning - Clostridial Myositis and Myonecrosis (Gas Gangrene) ● - Crush Injury, Compartment Syndrome and other Acute Traumatic Ischemias . - Decompression Sickness . - Enhancement of Healing in Selected Problem Wounds ● - Exceptional Blood Loss (Anemia) . - . Intracranial Abscess - Necrotizing Soft Tissue Infections . - Osteomyelitis (Refractory) . - Delayed Radiation Injury (Soft Tissue and Bony Necrosis) . - Skin Grafts and Flaps (Compromised) ● - Thermal Burns .

The BARA-MED® and its predicate devices have the same intended use: to promote the movement of oxygen into a patient's tissues by causing him to resvire oxygen at a pressure that is greater than that of the earth's atmosphere (i.e., 1 ATA). Specifically, the BARA-MED® and the predicate devices are indicated for air or gas embolism; carbon monoxide poisoning and carbon monoxide poisoning complicated by cyanide poisoning; clostridial myositis and myonecrosis (gas gangrene); crush injury, compartment syndrome, and other acute traumatic ischemias; decompression sickness; enhancement of healing in selected problem wounds; exceptional blood loss (anemia); intracranial abscess; necrotizing soft tissue infections; refractory osteomyelitis; delayed radiation injury (soft tissue and bony necrosis); compromised skin grafts and flaps; thermal burns. These indications for use are in accordance with the recommendations made by the Undersea and Hyperbaric Medical Society for the medical application of hyperbaric chambers. The BARA-MED® and its predicate devices have very similar general principles of operation. All of these chambers are pressurized and ventilated continuously with pure oxygen, and the patient breathes the chamber atmosphere. Also, in each of the chambers, the pressure-time profile i.e., the rate and direction of pressure change and the time held at any particular pressure), as well as the oxygen ventilation rate of any treatment, are controlled by the chamber's operator, either directly by means of a pneumatic or electronic system, or indirectly by means of an automatic electronic system. The purposes of such controls are to be able to conduct the particular hyperbaric oxygen treatment prescribed by the physician in a way that is save and comfortable for the patient, and to be able to respond appropriately and effectively to any contingency circumstance. The ETC BARA-MED® is designed and manufactured in accordance with the applicable sections of: - ASME Boiler and Presser Vessel Code, Section VII, Rules for ● Construction of Pressure Vessels, Division 1, 1998 Edition. - . ASME PVHO-1-1997, Safety Standard for Pressure Vessels for Human Occupancy. - NFPA 99, Standard for Health Care Facilities, Chapter 19, 199 . Edition. In all respects, the BARA-MED® is substantially equivalent to one or more clinical monoplace hyperbaric chambers that are legally marketed for the conduct of hyperbaric oxygen therapy.