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510(k) Data Aggregation
K Number
K051336Device Name
GERATHERM SOS-RESCUE BAG
Manufacturer
Date Cleared
2006-06-29
(402 days)
Product Code
Regulation Number
870.5900Why did this record match?
Applicant Name (Manufacturer) :
R.G. ENTERPRISES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Geratherm SOS-Rescue Bag is a temperature controlled electric whole body warming system intended for use in preventing or treating the effects of hypothermia in adults while at the rescue scene or during transport by air or ground to a medical facility.
Device Description
The Geratherm SOS-Rescue Bag is made up of five major components: 1. Bag: The main functional element is 78.75 inches (200cm) by 31.5 inches (80 cm) comprised of two primary elements: (a) The bag is constructed like a sleeping bag with an actively warmed upper panel and insulated bottom panel. The upper warming cover uses electrically resistive woven carbon fiber elements to generate warmth. The warming elements are sandwiched between two layers of Dacron® polyester hollow fiber insulating fleece. Lastly, the polvester fleece/carbon fiber layers are encapsulated with a waterproof polyurethane / polyester cloth laminate outside layer. A permanently attached power is cable located near the upper corner of the active warming cover. The free end is plugged into the power control module via color-coded quick-connect power connectors. The top warming cover is permanently sewn along one entire side to the insulated "bottom" panel. This arrangement allows top panel to be folded over the patient and secured once the patient has been placed in a prone position on the bottom panel. The bottom panel has 9 (nine) handholds around its perimeter that lets rescue personnel carry or move a supine patient without the use of a stretcher. (b) A removable waterproof polyurethane / polyester cloth laminate protective liner is attached to the bag's inner surface. The protective cover is held in place to the bag's inner surfaces with Velcro® attachments. This attachment system permits easy removal for machine washing and disinfecting. 2. Control Module: The control module is a impact plastic housing that contains the electronic circuitry. The module regulates bag temperature through a feedback circuit employing two thermistor temperature sensing systems. Operator control is achieved through the use of four buttons located on the face of the module: an on button, off button, a 37° C (98.6°F) select button, and a 42° C (107.6°F) select button. The control module uses LED arrays to display both bag temperature and battery power status. Normal functions are monitored both through visual displays and audible signal. Power sources include the following: the auxiliary battery, an automotive type power supply outlet, or an aircraft power supply outlet. Either 12 volt DC automotive or 24-28 volt DC aircraft power sources may be used to power the unit. 3. Battery: The Geratherm SOS-Rescue Bag uses a sealed lead-acid gel rechargeable battery of 10-ampere hour capacity. 4. Cabling: The Geratherm SOS-Rescue Bag has a power cable permanently attached to the upper corner. The cable attaches directly to the Control Module, The cable supplying power to the power module has a color-coded quick connect on the module end and a connecter that fits the auxiliary battery or automotive/aircraft DC power outlets on the other. 5. AC Charger: The Geratherm SOS-Rescue Bag employs a 12 volt, DC, 2ampere hour output battery charger to charge the battery or maintain full battery status. The charger may be used with either 110 or 240 Volt, 50 or 60 Hertz, AC input electric current.
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