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The intended use of the Sechrist Model 3300H/HR and Model 3600H/HR Hyperbaric Chambers are to administer 100% oxygen at pressure greater than ambient, up to 3 atmospheres absolute (30 psi) of pressure. Specific indication for use of the hyperbaric chambers have been established by the Committee on Hyperbaric Oxygen Therapy of the Undersea and Hyperbaric Medical Society (founded in 1967 to foster exchange of data on the physiology and medicine of commercial and military diving). The committee is comprised of practitioners and scientific investigations in the fields of internal medicine, infectious diseases, pharmacology, emergency medicine, general surgery, orthopedic surgery and aerospace medicine. The committee is responsible for continually reviewing research and clinical data in determining the safety and efficacy of hyperbaric oxygen. Currently, there are thirteen indications that are approved by the committee; these thirteen indications were accepted based on sound physiologic rationale, in vitro studies that demonstrate effectiveness, controlled animal studies, prospective controlled clinical studies and extensive clinical experience from multiple hyperbaric medicine centers. These thirteen indications have been recommended for third-party reimbursements and most insurance carriers have established reimbursement policy based on these recommendations. The thirteen indications are: - Air or Gas embolism 1. - 2. Carbon Monoxide Poisoning Carbon Monoxide Poisoning Complicated by Cyanide Poisoning - 3. Clostridial Myonecrosis and Myonecrosis (Gas Gangrene) - Crush Injury, Compartment Syndrome and Other Acute Traumatic Ischemia's 4. - ನ. Decompression Sickness - 6. Arterial Insufficiencies Central Retinal Artery Occlusion Enhancement of Healing In Selected Problem Wounds - 7. Severe Anemia - Intracranial Abscess 8. - ರು Necrotizing Soft Tissue Infections - 10. Osteomyelitis (Refractory) - 11. Delayed Radiation Injury (Soft Tissue and Bony Necrosis) - 12. Comprised Grafts and Flaps - 13. Thermal Burns

A hyperbaric oxygen chamber is a pressure vessel and control system that is designed to provide patient exposure to a very high oxygen concentration at higher than normal atmospheric pressure. Titration of the oxygen exposure is controlled by selecting the pressure achieved within the pressure vessel. Pressurization and de-pressurization rates are selected to minimize patient discomfort while increasing and decreasing the chamber pressure. Typical monoplace chambers are capable of pressurizing to 3 ATA (29.4 psig above atmospheric pressure). The typical pressurization and de-pressurization rates are in the range of 0.4 to 5.0 psig/minute. The Sechrist Models 3300H/HR and 3600H/HR Hyperbaric Chambers are monoplace pressure chambers designed to administer 100% oxygen at pressure greater than ambient, up to 3 atmospheres absolute (30 psig) of pressure. These hyperbaric chambers consist of a mechanical and pneumatic system capable of controlling the operator defined pressurization profiles. These Hyperbaric Chambers are constructed with a horizontal seamless acrylic viewport which varying internal diameter sizes. | Models | Internal Diameter | |------------------------------|----------------------| | 3300H/HR Hyperbaric Chambers | 32.50 inches (83 cm) | | 3600H/HR Hyperbaric Chambers | 35.50 inches (90 cm) | Each model is equipped with a clear anodized aluminum cover on one end and the other end with a hard anodized door assembly, with access ports available for patient interface (such as patient monitoring, delivery of intravenous fluids, etc.) locking mechanism and interlocking safety device. The cylinder, end cover and the door assembly are assembled together with stainless steel tie rods/nuts and hinge assembly. Each Hyperbaric Chamber Model comes in two configurations designated with a suffix of "H" and "HR". The suffix "H" is the Standard configuration where the control panel is located on the left of the chamber when facing the door and the door opens from left to right. The suffix "HR" is the Reverse configuration where the control panel is located on the right side of the chamber and the door opens from right to left. The functional performance system and the safety features incorporated in the Models 3300H/HR and 3600H/HR Hyperbaric Chambers are the same that have been incorporated into the design of the Model 4100H/HR predicate device. A pressurization cycle counter is provided to maintain a record of the number of pressurization cycles the chamber experienced. A two-way intercommunication system is used to maintain contact between patient and attendant.

The intended use of the hyperbaric chambers have been established by the Committee on Hyperbaric Oxygen Therapy of the Undersea and Hyperbaric Medical Society (founded in 1967 to foster exchange of data on the physiology and medicine of commercial and military diving). The committee is comprised of practitioners and scientific investigators in the fields of internal medicine, infectious diseases, pharmacology, emergency medicine, general surgery, orthopedic surgery, trauma surgery, thoracic surgery, otolaryngology, oral and maxillofacial surgery and aerospace medicine. The committee is responsible for continually reviewing research and clinical data in determining the safety and efficacy of hyperbaric oxygen. Currently, there are thirteen indications that are approved by the committee; these thirteen indications were accepted based on sound physiologic rationale, in vivo or in vitro studies that demonstrate effectiveness, controlled animal studies, prospective controlled clinical studies and extensive clinical experience from multiple hyperbaric medicine centers. These thirteen indications have been recommended for thirdparty reimbursement and most insurance carriers have established reimbursement policy based on the recommendations. The thirteen indications are: 1. Air or Gas embolism 2. Carbon Monoxide Poisoning Carbon Monoxide Poisoning Complicated by Cyanide Poisoning 3. Clostridial Myonecrosis and Myonecrosis (Gas Gangrene) 4. Crush Injury, Compartment Syndrome and Other Acute Traumatic Ischemias 5. Decompression Sickness 6. Arterial Insufficiencies Central Retinal Artery Occlusion Enhancement of Healing In Selected Problem Wounds 7. Severe Anemia 8. Intracranial Abscess 9. Necrotizing Soft Tissue Infections 10. Osteomyelitis (Refractory) 11. Delayed Radiation Injury (Soft Tissue and Bony Necrosis) 12. Compromise Grafts and Flaps 13. Thermal Burns

The Sechrist Model 4100H/HR Hyperbaric Chamber is a monoplace pressure chamber designed to administer 100% oxygen at pressure greater than ambient, up to 3 atmospheres absolute (30 ps) of pressure. The hyperbaric chamber is a mechanical and pneumatic system capable of controlling the operator defined pressurization profiles. A hyperbaric oxygen chamber is a pressure vessel and control system that is designed to provide patient exposure to a very high oxygen concentration at higher than normal atmospheric pressure. Titration of the oxygen exposure is controlled by selecting the pressure achieved within the pressure vessel. Pressurization and de-pressurization rates are selected to minimize patient discomfort while increasing and decreasing the chamber pressure. Typical monoplace chambers are capable of pressurizing to 3 ATA (29.4 psig above atmospheric pressure). Typical pressurization and de-pressurization rates are in the range of 0.4 to 5.0 psig/minute. The Model 4100H/HR is constructed with a horizontal 41 inch internal diameter seamless acrylic cylinder. One end is equipped with a hard anodized aluminum cover and the other end with a hard anodized door assembly, with access ports available for patient interface (such as patient monitoring, delivery of intravenous fluids, etc.) locking mechanism and interlocking safety device. The cylinder, end cover and the door assembly are assembled together with stainless steel tie rods/nuts and hinge assembly. The Model 4100 comes in two configurations (4100H and 4100HR). In the Standard configuration-4100H-the control panel is located on the left of the chamber when facing the door. In the Reverse configuration-4100HR-the control panel is located on the right side of the chamber.

The intended use of the Sechrist Model 3300E/ER Hyperbaric Chamber is to administer 100% oxygen at pressure greater than ambient, up to 3 atmospheres absolute (30 psi) of pressure. Specific indications for use of hyperbaric chambers have been established by the Committee on Hyperbaric Oxygen Therapy of the Undersea and Hyperbaric Medical Society. The current specific thirteen indications are: 1. Air or Gas Embolism 2. Carbon Monoxide Poisoning and Smoke Inhalation, Carbon Monoxide Complicated by Cyanide Poisoning 3. Clostridial Myonecrosis (Gas Gangrene) 4. Crush Injury, Compartment Syndrome and Other Acute Traumatic Ischemias 5. Decompression Sickness 6. Enhancement of Healing in Selected Problem Wounds 7. Exceptional Blood Loss (Anemia) 8. Intracranial Abscess 9. Necrotizing Soft Tissue Infections (Subcutaneous Tissue, Muscle, Fascia) 10. Osteomyelitis (Refractory) 11. Radiation Tissue Damage (Osteoradionecrosis) 12. Skin Grafts and Flaps (Compromised) 13. Thermal Burns

The Model 3300E/ER Hyperbaric Chamber is a monoplace (one patient) pressure chamber designed to administer 100% oxygen at pressure greater than ambient, up to 3 atmospheres absolute (30 psi) of pressure. The Model 3300E/ER Hyperbaric Chamber is constructed with a horizontal seamless acrylic inner cylinder. One end is equipped with a hard anodized aluminum cover and the other with a hard anodized aluminum door assembly, with access ports available for patient support (such as patient monitoring and delivery of intravenous fluids). The control system is pneumatic/electronic containing the controls, indicators, chamber pressure display gauges, and intercom assembly.

The intended use of the Sechrist Model 3500CP-G Air/Oxygen Mixer is to enable qualified personnel to mix medical grade air and medical grade oxygen at operator selected ratios, for delivery to patients through various types of respiratory care and heart bypass oxygenation equipment.

The Sechrist Model Series 3500CP-G Air/Oxygen Mixer is a precision pressure regulation and proportioning device which is intended to mix medical grade air and medical grade oxygen. The mixer receives pressurized air and oxygen, at a nominal 50 psi, via Diameter Index Safety System (D.I.S.S.) inlet connections. The unit will operate satisfactorily with inlet pressures of 30 to 70 psi, providing the pressures are within 20 psi of one another. Two outlets for the mixed gas are provided. The air/oxygen mixers are configured with zero to three flowmeters. Accessories include air and oxygen hoses.

The intended use of the device is to provide ventilation to neonatal, infant, and pediatric patients.

The Sechrist Millennium Infant Ventilator is an electro-pneumatic, continuous flow, time cycled, pressure limited infant ventilator. It is designed to ventilate neonatal to pediatric patients in Assist/Control, Synchronous Intermittent Mandatory Ventilation (SIMV), Continuous Positive Airway Pressure (CPAP), and Standby modes. In addition, pressure triggered ventilation and spontaneous breathing is also provided. The ventilator has an electronically controlled pneumatic system. The pneumatic subsystem consist of an air/oxygen mixer, continuous flow control, pressure controls, and waveform control. The electronically controlled subsystem uses the respiratory rate and inspiratory time control inputs to activate or deactivate the exhalation valve. The electronic subsystem also includes the pressure trigger sensing and manual breath functions. Comprehensive alarm, display, and measurement subsystems are designed to provide patient safety and ease of user interface.

The intended use of the device is to enable qualified personnel to mix medical grade air and medical grade oxygen, at operator selected ratios, for delivery to patients through various types of respiratory care equipment.

The Sechrist Series 3500HL Air-Oxygen Mixer is a precision pressure regulation and proportioning device which is designed to mix medical air with medical oxygen, for delivery to patients through a variety of respiratory care equipment. The mixer receives air and oxygen at a nominal 50 psi via Diameter Index Safety System (D.I.S.S.) inlet connections. The unit will operate satisfactorily with inlet pressures of 30 to 70 psi providing the pressures are within 20 psi of one another. Two outlets for the mixed gas are provided. One is located on the side of the unit for the convenient connection of a flowmeter. The second outlet may be used to power other respiratory or cardiopulmonary care equipment requiring a controlled FI02. The air-oxygen mixers are configured with zero to three flowmeters. Accessories include air and oxygen hoses. Flowmeters may also be purchased separately.