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510(k) Data Aggregation
K Number
K060739Device Name
MONOPLACE HYPERBARIC OXYGEN TREATMENT SYSTEM, MODEL BLKS-307
Manufacturer
KHRUNICHEV STATE RESEARCH & PRODUCTION SPACE CENTR
Date Cleared
2006-07-21
(123 days)
Product Code
CBF
Regulation Number
868.5470Why did this record match?
Applicant Name (Manufacturer) :
**KHRUNICHEV STATE RESEARCH **& PRODUCTION SPACE CENTR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The conditions listed as appropriate for the use of the Hyperbaric Oxygen Therapy in the current edition of Undersea and Hyperbaric Medical Society (UHMS) Hyperbaric Oxygen Therapy Committee Report (1999) are as follows:
- Air or gas embolism .
- Carbon monoxide poisoning and carbon monoxide poisoning complicated by . cyanide poisoning
- Clostridial myositis and myonecrosis .
- Crush injury, compartment syndrome, and other acute traumatic ischemias .
- Decompression sickness .
- Enhanced healing of selected problem wounds .
- Exceptional blood loss anemia .
- Necrotizing soft tissue infections .
- . Ostcomvelitis (refractory)
- Delayed radiation injury (soft tissue and bony necrosis) .
- Skin grafts and flaps (compromised) .
- Thermal burns .
- Intracranial abscess .
Device Description
The system body is a hermetic cylindrical chamber, which consists of a welded hermetic shell and a quick-to-open cover, made of the AMg6 -ASME Code Case 2403 aluminum alloy. The cover lock ring is made of the SB-211 A 92024 material. The hyperbaric oxygen chamber is installed on a base, which is made of carbon steel, with four wheel castors attached to the base bottom. It can be moved within a treatment room if necessary. A control panel is located atop of on the pressure chamber, actuating pneumatic aggregates of the pressure system pneumatic system which are located under the chamber body. A patient's ingress/egress is performed by means of a retractable chamber bed that is wheeled out of the pressure chamber on a portable gurney, which is attached to the chamber at the time the patient is placed in and out of the chamber. The pressure system overall dimensions BI.KS-307-"Khrunichev" without the gurney: length - 100 in, width - 48 in, height - 70.9 in. The pressure system total weight BLKS-307-"Khrunichev" - 1102 lbs. Chamber pressure control is achieved by means of knobs and tumbler switches of a pneumatic control panel located atop of the chamber. Both the rates of pressurization and depressurization are variable to provide patient's comfort while in confined space and with regards to his/her individual tolerance to pressure rate change. The panel is equipped with an emergency decompression push button, which enables fast treatment session termination and egress of a patient in case of an emergency situation. If pressure inside the chamber exceeds maximal operating level of 43.5 PSI, two pressure-relief valves installed on the pressure chamber shell will open. This provides for the patient and personnel safety and prevents the chamber structure damage. In order to exclude possible electric spark formation in an oxygen atmosphere in case of transition of an accumulated electrostatic potential from a patient to the chamber shell, an antistatic bracelet is provided. The bracelet is put on a patient hand or foot. The system is equipped with a grounding cable, which is connected to the treatment room grounding system.
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K Number
K011312Device Name
BLKS-303 MK MONOPLACE HYPERBARIC SYSTEM
Manufacturer
KHRUNICHEV STATE RESEARCH & PRODUCTION SPACE CENTR
Date Cleared
2001-07-18
(79 days)
Product Code
CBF
Regulation Number
868.5470Why did this record match?
Applicant Name (Manufacturer) :
**KHRUNICHEV STATE RESEARCH **& PRODUCTION SPACE CENTR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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