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The intended use of the Belmont Hyperthermia Pump is to raise the temperature of the thoracic or pentoneal cavity to the desired target temperature by continuously lavaging the cavity with circulating warmed sterile solution, according to a protocol to be selected by the physician.

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The intended use of the Belmont® buddy lite™ Fluid Warmer is to warm blood, blood products, and intravenous solution prior to administration. It is intended to be used by healthcare professionals in clinical environments to prevent hypothermia.

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The intended use of the Belmont® buddy lite™ Fluid Warmer is to warm blood, blood products, and intravenous solution prior to administration. It is intended to be used by healthcare professionals in clinical environments to prevent hypothermia.

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The intended use of the Belmont Hyperthermia Pump is to raise the temperature of the thoracic or peritoneal cavity to the desired target temperature by continuously lavaging the cavity with circulating warmed sterile solution, according to a protocol to be selected by the physician.

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The intended use of the Belmont Hyperthermia Pump is to raise the temperature of the thoracic or peritoneal cavity to the desired target temperature by continuously lavaging the cavity with circulating warmed sterile solution, according to a protocol to be selected by the physician.

The Belmont Hyperthermia Pump combines advanced microprocessor technology with an efficient mechanical system to provide a high speed, simple and safe system for rapid perfusion of warmed fluid. It can raise the temperature of the thoracic or peritoneal cavity to the desired target temperature by continuously lavaging the cavity with circulating warmed sterile solution, according to a protocol to be selected by the physician. The system monitors fluid temperature, patient temperature, line pressure, and air in the fluid path to ensure safe operation and alarms at all unsafe conditions. A hardware override circuit prevents unsafe operation in case of system computer failure. A touch screen displays flow rate, total fluid pumped, output fluid temperature, target temperature, patient temperature, line pressure, alarm and status messages and proper procedures to proceed safely after an alarm situation.

buddy plus™ Fluid Warmer intended use is for warming blood, blood products and intravenous solution prior to administration. It is intended to be used by healthcare professionals in clinical environments to prevent hypothermia.

The Belmont buddy plus™ Fluid Warmer is a portable in-line blood and fluid warmer. It consists of three components, a heater unit, a power module which powers the heater unit and displays alarm and status messages, and a single-use disposable heat exchanger set. The power module also contains a built-in battery pack which automatically switches over to the battery operation when the AC power is disconnected. When the power is restored, the system reverts to AC power automatically, the battery charger is activated, and the battery is charged. The heating technology used is resistive heating of two plates within the heater unit. The buddy plus™ Fluid Warmer warms intra-venous fluids, including blood and blood products, to physiological temperature, and monitors fluid temperature. It also senses lack of IV fluid flow, or empty set, and a number of internal fault conditions including over-heating, loss of electrical connection to the heater, and failure to heat. The device stops heating and alarms if an alarm or fault condition occurs. The system provides the user with alarm, alarm message, temperature, and other operating information via a bright alphanumeric display. The sterile disposable set is placed in-line between a standard IV line at its input and a user-supplied cannula or IV infusion set at its output. The input can come from a gravity fed IV line with roller clamp and drip chamber, external to the device and not supplied by Belmont Instrument Corp. The device is intended for low applications where the flow rate is 6 liter/hour (100 ml/min) or less.

buddy™ Fluid Warmer intended use is for warming blood, blood products and intravenous solution prior to administration. It is intended to be used by healthcare professionals in clinical environments to prevent hypothermia.

The Belmont buddy™ Fluid Warmer is a portable in-line blood and fluid warmer. It consists of three components, a heater unit, a power module and a disposable set. The power module powers the heater unit and displays alarm and status messages, and a disposable set which is placed in the heater unit and through which the fluid flows. The heating technology used is resistive heating of two plates within the heater unit. The buddy™ Fluid Warmer warms intra-venous fluids, including blood and blood products, to physiological temperature, and monitors fluid temperature. It also senses lack of flow, or empty set, and a number of internal fault conditions such as electrical connection to the heater, and failure to heat. The device stops heating and alarms if an alarm or fault condition occurs. The device provides the user with alarm, alarm message, temperature, and other operating information via a bright alphanumeric display. The sterile disposable set is placed in-line between a standard IV line at its input and a standard IV infusion set at its output. The input can come from a bag or supplied via a standard clamp and drip chamber, external to the device and not supplied by Belmont Instrument Corp. The device is intended for low flow applications where the flow rate is 6 liter/hour (100 ml/min) or less. This premarket application describes a modification to the disposable set.

Intended Use of the Jus 2000 (Unchanged by the modification): Infusion of crystalloid, colloid, or blood product, including packed red cells, as volume replacement for patients suffering from blood loss due to trauma or surgery. Infusion of warmed fluid to rewarm patients after surgery or for hypothermia. Infusion of warmed fluid for irrigation in urology purposes. Intended Use of the reservoir (Unchanged by the modification): The reservoir is used for convenience in infusing large volumes of fluid (rather than having to change individual bags.) Tubing and fittings are added, same as the existing reservoir, to be used with our current disposable set. The Belmont 7MS2000is for use in high blood loss surgical procedures, trauma and any situation where rapid replacement of warmed blood or replacement fluid at 10 -500 ml/min is required. It can also be used to deliver irrigation fluids at rates up to 500 ml/min. The reservoir is used to increase the fluid supply capacity of the Belmont instrument 7MS2000 3-Spike disposable Set.

The Belmont Fluid Management System (7MS2000) combines advanced microprocessor technology with an efficient mechanical system to provide a high speed, simple and safe system for rapid infusion of warmed fluid. The Belmont SMS2000 infuses blood, replacement IV fluids or irrigation fluids warmed to physiologic temperature at user-set rates from 10 to 500 milliliters per minute (ml/min). A low infusion rate at 2.5 ml/min (150 ml/hr) is also available without heating. The system monitors temperature, line pressure, and air in the fluid path to ensure safe operation and alarms at all unsafe conditions. A hardware override circuit prevents unsafe operation in case of system computer failure. A touch screen displays flow rate, total fluid infused, temperature, line pressure, alarm and status messages and proper procedures to proceed safely after an alarm situation. A battery backup allows for mobile transport of the patient and system. During battery operation, fluid warming is disabled while pump operation and safety monitoring remain active. The new reservoir, our own design, will be used instead of Gish Biomedical Inc. reservoir. The reservoir is used for convenience in infusing large volumes of fluid (rather than having to change individual bags.) Tubing and fittings are added, same as the existing reservoir, to be used with our current disposable set.

- Infusion of crystalloid, colloid, or blood product, including packed red blood cells, as A. volume replacement for patients suffering from blood loss due to trauma or surgery. - Infusion of warmed fluid to rewarm patients after surgery or for hypothermia. в. - Infusion of warmed fluid for irrigation in urology procedures. ். The Belmont FMS2000 is for use in high blood loss surgical procedures, trauma and any situation where rapid replacement of warmed blood or replacement fluid at 10 -750 ml/min is required. It can also be used to deliver irrigation fluids at rates up to 750 ml/min.

The Belmont Fluid Management System, JMS2000, combines advanced microprocessor technology with an efficient mechanical system to provide a high speed, simple and safe system for rapid infusion of warmed fluid. The Belmont JMS2000 infuses blood, replacement IV fluids or irrigation fluids warmed to physiologic temperature at user-set rates from 10 to 750 milliliters per minute (ml/min). A low infusion rate at 2.5 ml/min (150 ml/hr) is also available without heating. The system monitors temperature, line pressure, and air in the fluid path to ensure safe operation and alarms at all unsafe conditions. A hardware override circuit prevents unsafe operation in case of system computer failure. A touch screen displays flow rate, total fluid infused, temperature, line pressure, alarm and status messages and proper procedures to proceed safely after an alarm situation. A battery backup allows for mobile transport of the patient and system. During battery operation, fluid warming is disabled while pump operation and safety monitoring remain active.