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Celsi Warmer is intended for use in hospitals under a clinician's supervision or at their direction to assist nurses in continuous temperature monitoring and thermal treatment of neonates. a. Maintain pre-set body temperature as determined by the physician. b. Celsi Warmer is appropriate for neonates greater than 28 weeks gestational age who weigh between 1-4 kg. c. Monitoring and controlling patient temperature.

The Celsi Warmer is a portable, non-invasive thermal regulating system, indicated for continuous temperature monitoring and thermal treatment of neonates that require extra warmth to maintain normal body temperature. It uses a non-invasive thermometer (using direct mode) that measures the temperature of an infant's skin via a temperature probe placed on their abdomen to provide input into a physiological control loop that controls the mattress temperature. The Celsi Warmer is intended for use in hospitals under a clinician's supervision and is appropriate for neonates greater than 28 weeks gestational age who weigh between 1-4 kg. The Celsi Warmer is comprised of the following components: - Warming Mattress - Controller Tower - Celsi Temperature Probe and Celsi Belt - Power Supply and Cables

The Arctic Sun Temperature Management System is a thermal regulating system, indicated for monitoring and controlling patient temperature in adult and pediatric patients of all ages.

The Arctic Sun™ Stat Temperature Management System is a non-invasive, thermal regulating device that monitors and controls patient temperature within a range of 32°C to 38.5°C (89.6°F to 101.3°F). The system consists of a console, non-sterile single patient use ArcticGel™ Pads, and associated accessories. The Arctic Sun™ Stat Temperature Management System circulates temperature-controlled water ranging between 4°C and 40°C (39.2°F and 104°F) through the ArcticGel™ Pads, resulting in heat exchange between the water and the patient. A commercially available Yellow Springs Instrument (YSI) 400 series compatible patient temperature probe connected to the console provides patient temperature feedback to an internal control algorithm which automatically increases or decreases the circulating water temperature to achieve a pre-set patient target temperature determined by the clinician. The Arctic Sun™ Stat console has the option to provide secure data output of device monitoring values; there is no patient-identifiable information. The data output functions, including USB, RS-232, and Wi-Fi, do not allow the user to write to the device and are intended for user convenience only.

The HotDog Temperature Management System is intended to prevent or treat hypothermia and to provide warmth to patients. The System should be used in circumstances in which patients may not mantain a state of normothermia. The System can be used with adult patients. The System is intended primarily for use in hospitals and surgical centers including, without limitation, operating rooms, recovery rooms, emergency rooms, burn units and on other medical/surgical floors. The HotDog Return Electrode Mattress is intended to conduct monopolar electrosurgical energy from the target tissue of a patient back to one or two electrosurgical units (ESU) or generators in monopolar surgery. The HotDog Return Electrode Mattress is restricted to use with isolated monopolar electrosurgical generators. The HotDog Return Electrode Mattress is intended for use with adult patients only.

The HotDog Warming Mattress + Return Electrode (“Mattress") is part of a thermal regulating system, indicated for controlling patient temperature in adult patients. Mattresses utilize a flexible semi-conductive polymer fabric which warms the patient effectively within safe limits (controlled temperature, low watt density, low thermal mass) from a controller and sensor feedback loop. They are RF sealed in durable urethane shells designed to eliminate uncleanable crevices. Via a blue cable, they are powered with a low voltage floating isolated DC current, designed to safely operate in the most demanding clinical settings. Mattresses contain a green cable which enables the mattress to function as a capacitive return electrode for electrosurgery.

The Cocoon Convective Warming System, Model CWS7000, is indicated for patient warming. The Cocoon Convective Warming Unit, Model CWS7000 has been designed for use with Cocoon Disposable Patient Warming Gown Blankets. It is intended for use with children, adolescent, and adult patients.

The Cocoon Convective Warming System, Model CWS7000 is part of the Cocoon family of temperature management systems that consists of portable forced-air temperature management units, Cocoon™ Disposable Patient Warming Gown Blanket. The Cocoon Convective Warming System, Model CWS7000 comprises of the Cocoon Convective Warming Unit, Model CWS7000 unit and the Cocoon™ Disposable Patient Warming Gown Blankets. The Cocoon Convective Warming System, Model CWS7000 can be used in preoperative and postoperative settings. In a preoperative setting, the warming system provides prewarming and comfort warming. In a postoperative setting, the warming system provides comfort warming only. The Cocoon Convective warming system should be used by trained medical professionals only. The Cocoon™ Convective Warming System, Model CWS7000 is not intended for use in the operating room.

The Medline ComfortTemp Patient Warming System is intended to prevent and treat hypothermia. In addition, the temperature management system can be used to provide patient themal comfort when conditions exist that may cause patients to feel too warm or too cold. The temperature management system can be used with adult and pediatric patients.

The Medline ComfortTemp Patient Warming System is intended to prevent and treat hypothermia. In addition, the patient warming system provides thermal comfort when conditions exist that may cause patients to feel too warm or too cold. The patient warming system is for adult and pediatric patients. The Medline ComfortTemp Patient Warming System is used in acute care, post-acute care, operating room, and procedural rooms. The system consists of a reusable blower unit, a reusable hose, and single-patient use, disposable blankets. Replacement filters and hoses for the blower unit are additionally available as needed. All components of the ComfortTemp Patient Warming System are non-sterile. The blower unit connects to the single-patient use blanket through a reusable hose and provides forced warm air into the blanket using a PTC (positive temperature coefficient) heater, a fan/blower and a user-controlled interface. Depending on the model, the ComfortTemp blanket is placed either around, over, or underneath adult and/or pediatric patients. The blanket is comprised of two polypropylene and polyethylene layers, which allow the forced warm air to be dispersed over the patient's skin.

The FilteredFlo Warming Blanket is intended to be used with the IOB-507 patient warming system. The IOB-507 Temperature Management system is indicated for hypothermic patients for whom induced hyperthermia or localized increase in temperature is clinically indicated. These blankets are intended for adult and pediatric use.

The FilteredFlo warming blankets are used with the IOB Temperature Management System (previously cleared k231596) that draws ambient- temperature air through a 0.2 micron particulate air filter. The filtered air is warmed to a selected temperature. The warmed air enters the FilteredFlo Warming Blanket through the hose and is distributed through delivery channels. Perforations on the patient side of the air delivery channels in the warming blanket gently disperse the warmed air over and around the patient. The FilteredFlo warming blankets in the submission are the following: FF-243 ADULT/PACU BLANKET FF-244 PEDIATRIC BLANKET FF-246 INFANT UNDERBODY BLANKET FF-247 LARGE PEDIATRIC UNDERBODY BLANKET FF-248 ADULT UNDERBODY BLANKET FF-443 UPPER BODY BLANKET FF-442 LOWER BODY BLANKET FF-344 TORSO BLANKET FF-145 WARMING TUBE BLANKET These blankets are single-use and disposable. Each blanket consists of two layers of nonwoven polypropylene fabric coated with a layer of polyethylene. The layers are bonded together to form a distribution network of air delivery channels. The warm air is distributed around the blanket through the delivery channels and exits the blanket through a specially designed series of perforations in the patient side of the blanket.

The IQool System is a thermal regulating system indicated for monitoring and controlling patient temperature.

The IQool™ System is a non-invasive, thermal regulating system that monitors and controls patient temperature within a range of 33°C to 38.5°C (91.4°F to101.3°F). The IOooL™ System consists of: - ECU 100 Refrigeration and Control Unit an integrated control system operated via a . touch screen monitor. - BC COOL a cooling liquid consisting of diluted monopropylene glycol (MPG5). The ● dilution is made by BrainCool AB to optimally serve the IQool™ System. Five liters of BC COOL are delivered with the system. - Cooling Pads The Cooling Pads are made of non-sterile, biocompatible material and do ● not contain latex. The Cooling Pads are intended for single use only. - . Stabilization Insulation - The patented stabilization is made of insulating and moisture-absorbent neoprene. It insulates against the ambient environment while counteracting condensation. The elasticity of the stabilization keeps the Cooling Pad in place during treatment and ensures maximum contact between the skin and the surface of the Cooling Pad. The stabilizing insulation is intended for single use only. Accessories: - BC Stick a USB flash drive used to save system configurations, specifically prepared to ● communicate with the program of the IQool™ System. The BC stick does not store or capture any user identifying information. It can also be used to save a log file for system troubleshooting or to update the software. - Filling Pitcher - The filling pitcher should be used to fill or refill the coolant tank. Fill the tank with coolant before or directly after starting to enable start of the system. The IQool™ System is a thermoregulatory device that monitors and controls patient temperature within a range of 33°C to 38.5°C. The IQool System refrigeration and control unit (ECU 100) pushes a temperature-controlled cooling agent (BC COOL), ranging between 4°C and 40°C, through the Cooling Pads applied to the patient. This results in heat exchange between the BC COOL and the patient. Patient core temperature is monitored and controlled based on the temperature probe (PT1) attached to the system. The IQool™ System maintains a controlled patient temperature during the entire treatment period. The default treatment settings for temperature and time can be changed via the touchscreen monitor. Alarms and notifications are activated if any errors are detected. Temperature graphs for each treatment are shown on the touchscreen display for visual monitoring. After a treatment, a detailed log file can be collected with the memory stick (BC STICK).

The Barrier EasyWarm Active Self-Warming Blanket is intended to help prevent hypothermia by providing warmth to the patient during the perioperative period.

The Barrier EasyWarm Active Self-Warming Blanket is a non-sterile, single use blanket that is intended to prevent hypothermia by providing warmth to the patient during the period. The blanket contains warming pads (or heating elements) that are contained within sealed pouches that are advantageously positioned and sewn into the blanket's fabric for appropriate distribution of heat. The warming pads contain iron, active coal, water, salt, clay with a sodium polyacrylate cover. The device is supplied in a vacuum sealed packaging. Once the blanket is removed from its packaging, the blanket produces heat via an exothermic chemical reaction that takes place within the warming pads upon exposure to air. The chemical reaction results from the oxidation of iron.

The IOB Temperature Management System Model IOB-507 is indicated for hypothermic patients or normothermic patients for whom induced hyperthermia or localized increase in temperature is clinically indicated.

The IOB Temperature Management System Model IOB-507 consists of the IOB Warming Unit and the IOB Warming Blankets. The IOB Warming Unit, model IOB-507, draws ambient- temperature air through a 0.2 micron air filter. The filtered air is warmed to a selected temperature. The warmed air enters the IOB Warming Blanket through the hose and is distributed through delivery channels. Perforations on the patient side of the air delivery channels in the warming blanket gently disperse the warmed air over and around the patient. The warming unit has three temperature settings of 32℃, 38℃, and 43℃. These temperature settings are servo-controlled by a thermistor placed at the end of the hose where the hose connects to the blanket. The unit can also deliver ambient-temperature air. The temperature indicated on the control panel is the temperature of air being delivered to the average contact surface temperature of the blanket. A control thermistor in the warming unit adjusts the power applied to the heater to maintain the selected temperature. This enables the unit to maintain the selected temperature under variations in ambient temperature. Besides, the warming unit has high and low air flow options. A safety thermistor provides a signal to a separate high-temperature analog circuit. The safety thermistor activates and produces an alarm if the temperature exceeds the set point. The analog safety circuit provides an independent means of shutoff, which discontinues power to the heater and motor. This prevents patient exposure to excessive temperatures. IOB warming blankets are single-use and disposable. Each blanket consists of two layers of non-woven polypropylene fabric coated with a layer of polyethylene. The layers are bonded together to form a distribution network of air delivery channels. The warm air is distributed around the blanket through the delivery channels and exits the blanket through a specially designed series of perforations in the patient side of the blanket.

The HotDog Temperature Management System is intended to prevent or treat hypothermia and to provide warmth to patients. The System should be used in circumstances in which patients may not maintain a state of normothermia. The System can be used with adult patients. The System is intended primarily for use in hospital centers including, without limitation, operating rooms, recovery rooms, emergency rooms, burn units and on other medical/surgical floors. The HotDog Return Electrode Mattress is intended to conduct monopolar electrosurgical energy from the target tissue of a patient back to one electrosurgical unit (ESU) or generator in monopolar surgery. The HotDog Return Electrode Mattress is restricted to use with isolated monopolar electrosurgical generators. The Hotdog Return Electrode Mattress is intended for use with adult patients only.

The HotDog Warming Mattress + Return Electrode (“Mattress”) is part of a thermal regulating system, indicated for controlling patient temperature in adult patients. Mattresses utilize a flexible semi-conductive polymer fabric which warms the patient effectively within safe limits (controlled temperature, low watt density, low thermal mass) from a controller and sensor feedback loop. They are RF sealed in durable urethane shells designed to eliminate uncleanable crevices. Via a blue cable, they are powered with a low voltage floating isolated DC current, designed to safely operate in the most demanding clinical settings. Mattresses contain a green cable which enables the mattress to function as a capacitive return electrode for electrosurgery.