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The Smisson-Cartledge Biomedical ThermaCor® 1200 Rapid Thermal Infusion System is indicated for use over a full range of flow rates from slow feed to rapid, high flow infusion of: crystalloid, colloid, or blood product, including packed red blood cells [not in additive . solutions and stored up to 21 days with anticoagulants], as volume replacement for patients suffering from blood loss due to trauma or surgery; warmed fluid to rewarm patients after surgery or for hypothermia; warmed fluid for irrigation in urology procedures.

The ThermaCor® 1200 Disposable Sets are intended for use only with the Smisson-Cartledge Biomedical (SCB) ThermaCor® 1200 Rapid Thermal Infusion System. The Disposable Sets consist of configurations that include cassettes with tubing connectors, various patient lines, and supply lines capable of interfacing with intravenous (IV) bags or optional-use reservoir equipment. Use of the ThermaCor® 1200 Disposable Sets ensures the intended use of the ThermaCor® 1200 Rapid Thermal Infusion System is met. The ThermaCor® 1200 Disposable Sets are provided sterile, non-pyrogenic and are single patient use only. They are sterilized by Ethylene Oxide (EO) sterilization method. The Smisson-Cartledge Biomedical ThermaCor® 1200 Rapid Thermal Infusion System is a portable or pole-mounted device intended for use in the hospital emergency room (ER), operating room (OR), intensive care unit (ICU), and Labor and Delivery (L&D) environments. The system consists of an infusion device and a compatible, single patient use sterile disposable set with supply lines capable of interfacing with intravenous (IV) bags or an optional reservoir. The ThermaCor® 1200 Infuser may be used with a Footswitch (optional accessory) to allow hands-free, user-controlled delivery. The ThermaCor® 1200 Infuser can deliver flow rates from 10 mL per Hour to 1200 mL per Minute selectable in 10mL/hr in Slow mode and 20mL/min in Rapid mode at normothermic temperatures and is intended for continuous operation. The ThermaCor® 1200 Rapid Thermal Infusion System is driven by a volumetric pump capable of variable-rate continuous infusion up to approximately 100 Liters total volume per Cassette. The system is also capable of delivering discrete bolus infusions. The user can select Bolus Mode to deliver a fixed, predetermined bolus of up to 1 Liter at a default or adjustable rate. When connected to alternating current (AC) power, the ThermaCor® 1200 Infuser can deliver fluids warmed to body temperature under most conditions. The Infuser can also run on battery power (heating capabilities will be disabled) to allow transport of the patient. A lithium-ion battery pack provides the power backup.

Full range from slow feed to rapid, high flow infusion of: - crystalloid, colloid, or blood product, including packed red blood cells, as volume . replacement for patients suffering from blood loss due to trauma or surgery - warmed fluid to rewarm patients after surgery or for hypothermia . warmed fluid for irrigation in urology procedures .

The Smisson-Cartledge TIS-1200 Thermal Infusion System is a portable tabletop or polemount device intended for use in the ambulance, medical helicopter, hospital emergency room and operating room environments. (See Exhibits A and B for photographs and drawings) The system consists of an infusion device and a compatible single-use sterilized disposable set with supply lines capable of interfacing with intravenous (IV) bags or optional-use cardiotomy equipment. It also includes a footswitch to allow hands-free user-controlled stopping and starting of fluid delivery. The Smisson-Cartledge TIS-1200 Thermal Infusion System is a volumetric pump capable of continuous infusion (up to approximately 100 L at a rate of from 10 mL per hour to 1200 mL per minute) and discrete bolus delivery. When the system is set to Bolus mode, the user can select a predetermined delivery volume and a default or adjustable rate and deliver a fixed bolus of up to 1 L. When connected to alternating current (AC) power, the Smisson-Cartledge TIS-1200 Thermal Infusion System can deliver fluids at body temperature in certain modes. It can also be set to run on battery power with heating capabilities disabled to allow transport of the patient. A lithium-ion battery pack provides power backup. The unit (infusion pump) and Large Volume Reservoir Holder are provided non sterile. The Disposable Cassette Kit and Large Volume Reservoir are provided sterile, non-pyrogenic and are single-use only. They are sterilized by Ethylene Oxide (EO) sterilization method.