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The SIGMA Elite 34, 36 and 40 Monoplace Hyperbaric Chambers are intended for use for the following clinical medical conditions in accordance with guidelines established by the Undersea and Hyperbaric Medical Society, as follows: Air or Gas Embolism; Carbon Monoxide / Smoke Inhalation; Compromised Skin Grafts and Flaps; Crush Injuries / Acute Traumatic Ischemia; Decompression Sickness; Enhanced Healing in Selected Problem Wounds; Exceptional Blood Loss (Anemia); Gas Gangrene (Clostridia Myonecrosis); Intracranial Abscess; Necrotizing Soft Tissue Infections; Radiation Tissue Damage (Osteoradionecrosis); Refractory Osteomyelitis; Thermal Burns.

The SIGMA Elite Series Hyperbaric Chambers and their 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 SIGMA Elite Series Hyperbaric Chambers and their 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 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 safe and comfortable for the patient, and to be able to respond appropriately and effectively to any contingency circumstance.

The SIGMA 3400 Monoplace Hyperbaric Chamber is indicated for use for the following clinical medical conditions in accordance with guidelines established by the Undersea and Hyperbaric Medical Society, as follows: 1. Air or Gas Embolism 2. Carbon Monoxide / Smoke Inhalation 3. Compromised Skin Grafts and Flaps 4. Crush Injuries / Acute Traumatic Ischemias 5. Decompression Sickness 6. Enhanced Healing in Selected Problem Wounds 7. Exceptional Blood Loss (Anemia) 8. Gas Gangrene (Clostridial Myonecrosis) 9. Intracranial Abscess 10. Necrotizing Soft Tissue Infections 11. Radiation Tissue Damage (Osteoradionecrosis) 12. Refractory Osteomyelitis 13. Thermal Burns

The Perry Baromedical Corporation SIGMA 3400 Monoplace Hyperbaric Chamber is substantially equivalent to the Perry Baromedical Corporation SIGMA I Monoplace Hyperbaric Chamber, [510(k) K832127], and the Perry Baromedical Corporation SIGMA Plus Monoplace Hyperbaric Chamber, [510(k) 974863]. The SIGMA 3400 has the same intended use and the same technological characteristics as the SIGMA I and SIGMA Plus predicate devices. The scope and operation of the SIGMA 3400 is identical to that of the SIGMA I and SIGMA Plus in the following areas: - The critical component of both systems consists of an ASME pressure vessel that is designed, fabricated, and tested in accordance with the requirements of the ASME Boiler and Pressure Vessel Code, Section VIII, Division 1; and ASME PVHO-1, Safety Standard for Pressure Vessels for Human Occupancy. - The pressure vessel consists of certified metal components constructed of materials in conformance with the ASME Boiler and Pressure Vessel Code, Section II - Materials. In addition to the metal parts, the pressure retaining boundary consists of an acrylic plastic cylinder, designed and constructed to the requirements of ASME PVHO-1, Safety Standard for Pressure Vessels for Human Occupancy. - The pressure vessel is protected from accidental over pressurization by an ASME "UV" stamped pressure relief valve. - The medium used for pressurization of the chamber is medical grade oxygen. - Treatment capacity of the chamber is one patient. - Communication between the patient / attendants is through an intrinsically safe communications system. - The SIGMA I, SIGMA Plus and SIGMA 3400 chambers are used to provide Hyperbaric Oxygen Therapy, prescribed by a licensed physician, where medical grade oxygen is administered to patients while under pressure, by the patient breathing oxygen from the chamber atmosphere that is pressurized with pure oxygen. The breathing of oxygen at elevated pressure promotes the movement of oxygen into the patient's tissues. - The chamber pressurization and depressurization control system is completely pneumatic, with no electrical or electronic components. - Chambers are Class "B" monoplace hyperbaric systems. Differences do exist between the SIGMA 3400, the SIGMA Plus and the SIGMA I chambers; they include: - The PVHO-1 acrylic cylinder in the SIGMA 3400 chamber is 33.3" inside diameter and 90" long; the PVHO-1 acrylic cylinder in the SIGMA Plus chamber is 40" inside diameter by 65" long, and the PVHO-1 acrylic cylinder in the SIGMA I chamber is 25.25" inside diameter by 80" long. - The acrylic cylinder of the SIGMA 3400 has been designed for a operational temperature range of 32 degrees F to 100 degrees F. The SIGMA I and SIGMA Plus cylinders were designed for a 32 degree F to 125 degree F operating range. Based on the actual operating environment of a hospital, the higher 125 degree temperature limit would never be reached in normal operation, as the chamber rooms are required to be maintained at temperatures less than 75 degrees F for patient comfort. - The pneumatic controls for the SIGMA 3400 chamber and the SIGMA I chamber are mounted in a panel mounted on one side of the chamber. The pneumatic controls for the SIGMA Plus chamber are mounted in a control box that is suspended from a moveable arm. - The SIGMA 3400 monoplace chamber has an aluminum chassis with integral side covers; the SIGMA Plus Chamber has gelcoated fiberglass cosmetic covers on the sides and ends of the chamber; and the SIGMA I Hyperbaric Chamber has aluminum side cosmetic covers as part of the chassis. - The SIGMA 3400 monoplace chamber has provision for changing from oxygen to air pressurization during treatment, which allows the operator more control of the environment inside the chamber. The SIGMA Plus and SIGMA I chambers are oxygen only pressurization.

The monoplace hyperbaric chamber is indicated for use for the following clinical medical conditions in accordance with guidelines established by the Undersea and Hyperbaric Medical Society, as follows: 1. Air or Gas Embolism 2. Carbon Monoxide / Smoke Inhalation 3. Compromised Skin Grafts and Flaps 4. Crush Injuries / Acute Traumatic Ischemias 5. Decompression Sickness 6. Enhanced Healing in Selected Problem Wounds 7. Exceptional Blood Loss (Anemia) 8. Gas Gangrene (Clostridial Myonecrosis) 9. Intracranial Abscess 10. Necrotizing Soft Tissue Infections 11. Radiation Tissue Damage (Osteoradionecrosis) 12. Refractory Osteomyelitis 13. Thermal Burns

The Perry Baromedical Corporation SIGMA Plus Monoplace Hyperbaric Chamber is substantially equivalent to the Perry Baromedical Corporation SIGMA I Monoplace Hyperbaric Chamber, [510(k) K832127]. The SIGMA Plus has the same intended use and the same technological characteristics as the SIGMA I predicate device. The scope and operation of the SIGMA Plus is identical to that of the SIGMA I in the following areas: - The critical component of both systems consists of an ASME pressure vessel that is designed, fabricated, and tested in accordance with the requirements of the ASME Boiler and Pressure Vessel Code, Section VIII, Division I; and ASME PVHO-1, Safety Standard for Pressure Vessels for Human Occupancy. - The pressure vessel consists of certified metal components constructed of materials in conformance with the ASME Boiler and Pressure Vessel Code, Section II - Materials. In addition to the metal parts, the pressure retaining boundary consists of an acrylic plastic cylinder, designed and constructed to the requirements of ASME PVHO-1, Safety Standard for Pressure Vessels for Human Occupancy. - The pressure vessel is protected from accidental over pressurization by an ASME "UV" stamped pressure relief valve. - The medium used for pressurization of the chamber is either compressed pure oxygen or compressed breathing air. - Treatment capacity of the chamber is one (1) patient. - Communication between the patients / attendants is through an intrinsically safe communications system. - The SIGMA I and SIGMA Plus chambers are used to provide Hyperbaric Oxygen Therapy, prescribed by a licensed physician, where medical grade oxygen is administered to patients while under pressure; either by the patient breathing the chamber atmosphere, (when pressurized with oxygen), or by the patient breathing oxygen from a breathing hood or breathing mask, (when pressurized with breathing air); The breathing of oxygen at elevated pressure promotes the movement of oxygen into the patient's tissues. - The chamber pressurization and depressurization control system is completely pneumatic, with no electrical or electronic components. Differences do exist between the SIGMA Plus and the SIGMA I Monoplace chamber; they include: - The PVHO-1 acrylic cylinder in the SIGMA Plus chamber is 40" inside diameter, and the PVHO-1 acrylic cylinder in the SIGMA I chamber is 25.25" inside diameter. Both acrylic cylinders are designed with a 20 to 1 safety factor. - The pneumatic controls for the SIGMA Plus chamber are mounted in a control box that is suspended from a moveable arm, allowing use from either side of the chamber; while the pneumatic controls for the SIGMA I chamber are mounted in a panel on one side of the chamber. - The SIGMA Plus Monoplace Hyperbaric Chamber has painted fiberglass cosmetic covers on the sides and ends of the chamber; the SIGMA I Monoplace Hyperbaric Chamber has a wheeled aluminum support chassis.