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The Palladium High Flow Therapy System is intended to deliver warmed and humidified high-flow respiratory gases to spontaneously breathing adult and pediatric patients weighing at least 3.5 kg within hospital, sub-acute and homecare settings.

The Palladium High Flow Therapy System is designed to heat and humidify respiratory gases and deliver high flow respiratory therapy via a small-bore nasal cannula to spontaneously breathing pediatric and adult patients within hospital, sub-acute and homecare settings. Palladium is portable, self-contained, AC driven or battery powered with high flow therapy driven by an internal blower room air source and supplied with external oxygen or other gas sources, which is the same as the predicate Vapotherm Flowrest® device. Palladium utilizes similar semi-permeable small-bore tubing technology for humidification and integrity of a closed, single-use water path disposable as the reference Vapotherm Precision Flow® device.

Precision Flow® HVNI is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patients in the hospital and subacute institutions settings. It adds heat and moisture to a blended medical air/ oxygen mixture and assures the integrity of the precise air/oxygen mixture via an integral oxygen analyzer. The flow rates may be from 1 to 40 liters per minute via nasal cannula. Precision Flow® HVNI provides high velocity nasal insufflation (HVNI) with simultaneous oxygen delivery to augment breathing of spontaneously breathing patients suffering from respiratory distress and/or hypoxemia in the hospital setting. Precision Flow® HVNI is not intended to provide total ventilatory requirements of the patient and not for use during field transport.

The Precision Flow® HVNI system delivers high flow rates of heated and humidified blended breathing gas through high flow nasal cannulas. The Precision Flow® HVNI system can connect to air and oxygen source. The Precision Flow® HVNI may be operated with limited performance at gas inlet pressures as low as 4 psi (28 kPa). For the full specified range of gas flows and oxygen percentages, both gas inlet pressures must be at minimum 40 psi (276 kPa).The main unit contains an integrated blender that delivers the targeted gas mixture to the disposable patient circuit (DPC). The Disposable Patient Circuit contains: - Water path: tubing from sterile water supply to vapor transfer cartridge - . Vapor transfer (humidification) cartridge: 2 types; low flow (1-8 lpm) and high flow (5-40 lpm) - Delivery Tube: triple lumen tubing - . Nasal Cannula The device automatically senses cartridge type. The available set temperature range is 33 °C to 39 °C. The device also contains a backup battery to provide power only for 15 minutes.

The Precision Flow® - Heliox is intended to warm and add moisture to breathing gases from an external source for administration to neonate/infant, pediatric and adult patients in the hospital and sub-acute institutions. It adds heat and moisture to a blended medical heliox (79% helium. 21% oxygen)/oxygen mixture and assures the integrity of the precise heliox (79% helium, 21% oxygen)/oxygen mixture via an integral oxygen analyzer. The flow rates may be from 1 to 40 liters per minute via nasal cannula.

The Precision Flow® - Heliox consists of two parts: The main unit which contains all the electrical and electronic components including the electronic blender and flow controllers. All the sensors are located in the main unit. The main unit has no water pathways and the gas pathway contains only dry gas at room temperature, and consequently does not need internal cleaning or disinfection. The disposable components comprising the disposable water module, vapor transfer cartridge and heated delivery tube. Conditions in the circulating water and gas streams are sensed remotely via the interface between the main unit and the disposable module.

The Flowrest® delivers warmed humidified high-flow breathing gases. The Flowrest® is intended for treating spontaneously breathing patients who require warmed and humidified high-flow respiratory gases within the homecare, subacute and hospital settings.

The Flowrest® is an integrated non-invasive high flow device incorporating a blower, an air flow heater, a heated humidifier, and a dual lumen breathing circuit and cannula. Filtered room air is drawn in through a blower, where it passes a heater. The heated air is split between the inner lumen and outer lumen of the dual lumen breathing circuit. The heated air in the inner lumen passes through a heated humidifier and is delivered to the patient through a cannula. The heated air in the outer lumen passes through the entire length of the breathing circuit and serves to insulate the humidified patient air, thus minimizing condensation and rainout. The Flowrest® is comprised of two functional, yet integrated components. One is a motorized fan assembly that provides the physician prescribed high flows of heated breathing and insulating gases between 15 and 35 liters per minute. The fan speed is directly related to flow rate and is controlled by software. The blower assembly output connects directly to a humidification chamber at the front of the device. The second component of the Flowrest® is a heated humidifier. The water is contained in the humidification chamber positioned on a heater plate at the front of the unit. The chamber connects directly to the blower assembly. Air flow from the device passes through the heated humidification chamber, is warmed and humidified and after passing through the breathing circuit, is delivered to the patient through a cannula. The second flow of warm air through the outside lumen of the delivery tube bypasses the humidification chamber through the top of the humidifier chamber. Ambient temperature is monitored in order to reduce humidified patient air condensation. Temperature controls are controlled by software.

Precision Flow™ is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patients in the hospital, sub-acute institutions, and home settings. It adds heat and moisture to a blended medical air/oxygen mixture and assures the integrity of the precise air/oxygen mixture via an integral oxygen analyzer. The flow rates may be from 1 to 40 liters per minute via nasal cannula.

The Precision Flow™ consists of two parts: The main unit which contains all the electrical and electronic components including the electronic blender and flow controllers. All the sensors are located in the main unit. The main unit has no water pathways and the gas pathway contains only dry gas at room temperature, and consequently does not need internal cleaning or disinfection. The disposable components comprising the disposable water module, vapor transfer cartridge and heated delivery tube. Conditions in the circulating water and gas streams are sensed remotely via the interface between the main unit and the disposable module.

The Vapotherm 2000i and 2000h are designed to add moisture to and to warm breathing gases for administration to patients, including neonates/infants, and adults. The flow rates may be from 1 to 40 liters per minute via nasal cannula. Environments for use -- Home, Hospital, Sub-acute Institutions.

The Vapotherm 2000i device is a modification to cleared Vapotherm 2000i device. The base device of the modified Vapotherm 2000i device has the same technological characteristic as the predicate Vapotherm 2000i device. The software contained in the modified device has not been modified as a result of the corrections being effected and remains identical to the software resident in the predicate device.

The Vapotherm™ 2000h and 2000i are designed to add moisture to and to warm breathing gases for administration to patients, including neonates/infant, pediatrics, and adults. The flow rates may be from 1 to 40 liters per minute via nasal cannula. Environments of use - Home, Hospital, Sub-acute Institutions

The Vapotherm 2000i and Vapotherm 2000h are identical and share the concept of humidification by transpiration of water vapor across a membrane by the use of a low or high flow cartridge with membrane bundles. The difference in the cartridges is only the number of membrane bundles included, fewer in the low flow. Both units and cartridges produce a highly humidified air (relative humidity >95%), virtually free of droplets, at body temperature or above at flow rates from 1 to 40 lpm via a nasal cannula. The water content at 41℃ is 40-50 mg/liter, about fourfold higher than can be achieved by humidification at room temperature. The unique combination of high flow and high vapor-phase humidity allow an unusually wide range of clinical applications. Applications previously considered impractical because of limited patient tolerance for high nasal flow can now be routine because of the comfort provided by warmth and high humidity.

The Vapotherm 2000h (5000) can mix air with oxygen from an external source and adds heat and moisture to the gas. The Vapotherm 2000h (5000) is for use in home, hospital or sub-acute institutional settings.

The Vapotherm 2000i, predicate, and the Vapotherm 2000h (5000) are identical and share the concept of humidification by transpiration of water vapor across a membrane. Both produce a high flow of highly humidified air (relative humidity >95%), virtually free of droplets, at body temperature or above. The water content at 41°C is 40-50 mg/liter, about fourfold higher than can be achieved by humidification at room temperature. The unique combination of high flow and high vapor-phase humidity allow an unusually wide range of clinical applications. Applications previously considered impractical because of limited patient tolerance for high nasal flow can now be routine because of the comfort provided by warmth and high humidity. The Vapotherm 2000h (5000) is an unmodified Vapotherm 2000i but with an internal air compressor and external oxygen source, wall or cylinder oxygen. There is a single inlet fitting. like the 2000i for connection to an external oxygen source, if desired.