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Oxymag is a controlled volume, pressure and time cycled emergency and transport ventilator. It is intended for use with infant, child, and adult patients with a tidal volume from 50 ml upwards who are in respiratory and/or cardiac arrest or respiratory distress and who require the ventilatory support. It is intended for pre-hospital and hospital use including intra-hospital, inter-hospital and transport settings.

Oxymag provides a mixture of ambient air and oxygen at concentrations adjusted by the operator using the accurate oxygen concentration system using the venturi principle. O2 concentration is obtained through a galvanic cell by passing gas through the sensor. In addition, it performs the control of flows and pressures in the respiratory circuit to provide the ventilation modalities appropriate to the patient's condition. The associated accessories include: - Power outlet 12V/3,34A - AC cable - Disposable respiratory circuit - 02 extension - Environment filters

The VORTRAN GO2VENT with PEEP Valve is to be used by properly trained personnel to deliver emergency, shortterm, constant flow, pressure-cycled ventilatory support on patients weighing 10 kg and above.

The device consists of a modulator (an exhalation valve that opens at PIP and closes at PEEP), a mechanical manometer, a resistor (which is referred to as the PEEP Valve) attached within the exhalation path for elevating the PEEP further than can be set with the modulator, a patient connector tee to supply gas flow, entrain additional air, and connect to a face mask or a tube inserted into a patient's airway, and two associated accessories. It is intended to be used by properly trained personnel in any environment in which emergency ventilation is required. The VORTRAN GO₂VENT with PEEP Valve provides short-term, constant flow, pressure-cycled ventilatory support in either pressure control or pressure support mode. In pressure support mode, the rate dial of the VORTRAN GO₂VENT with PEEP Valve is set so that the baseline pressure is set above the set PEEP. This allows the patient to initiate inhalation by drawing the baseline pressure down to the set PEEP. In pressure control mode, the device will automatically cycle between PIP and PEEP when connected to a patient's airway. The working mechanism of the VORTRAN GO₂VENT with PEEP Valve consists of a moving diaphragm that opens the exhalation path when the pressure reaches PIP and closes when the pressure reaches PEEP. Without the PEEP Valve, PEEP will be approximately 20% of the set PIP. With the PEEP Valve attached, the PEEP will be increased from this value up to 24 cm-H₂O depending on the patient's compliance and the VORTRAN GO₂VENT with PEEP Valve's settings. The PEEP Valve is attached within the exhalation path by connecting it between the modulator and the patient connector tee. The pressure at which the diaphragm opens and closes against the valve is controlled by the amount of spring force acting against the diaphragm's movement. The spring force is adjusted by manually turning a threaded knob that varies the amount of spring compression. The device is constructed of a variety of plastics such as K-Resin, HDPE, polycarbonate, and silicone, as well as copper beryllium springs. The VORTRAN GO₂VENT with PEEP Valve is an external communicating device with limited and prolonged tissue contact duration (up to 30 days) via the breathing gas pathway. The associated accessories were included with the cleared predicate device (K162968) and include: - . Elbow flex hose for connecting the patient connector tee to a face mask or a tube inserted into a patient's airway - Oxygen tubing for connecting the patient connector tee to a gas supply

MEDUMAT Easy CPR is an electrical, pneumatically operated emergency and transport ventilation used for ventilation and oxygen inhalation with either a mask or tube. Patient groups Adults and children with a body weight of over 22 lbs (10 kg) where spontaneous respiration has failed or is inadequate. Users Qualified medical personnel only Intended environments of use · Mobile use for emergency medicine and primary care during emergency deployments · During land or air transport or transfer between hospital rooms and departments

MEDUMAT Easy CPR is an electrical, pneumatically operated emergency and transport ventilator. Highly compressed medical oxygen is used as the ventilation gas; this is reduced to the necessary operating pressure via an external pressure reducer. The oxygen is supplied at the compressed gas connection. The ventilation parameters – frequency and tidal volume - are linked together and can be set using the adjusting knob on the device. The ventilation gas is transported to the patient through the ventilation hose via the patient valve and ventilation mask or via the tube. The lip membrane in the patient valve allows the patient exhalation of expiration gas. In order to monitor the patient, the device features continuous measurement of the airway pressure as well as a visual and audible alarm system.

The Puffin Lite Infant Resuscitator is intended to provide the basic equipment required for pulmonary resuscitation of neonatal infants. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen or air/oxygen mixtures and/or manual ventilation to the neonatal infant.

The resuscitation system provides the basic equipment required for pulmonary resuscitation of neonatal infants. The Puffin Lite Infant Resuscitator is a gas powered emergency resuscitation system. It is intended to be used inside the hospital by trained medical professionals to provide precise FIO2 delivery, and manual ventilation as established by resuscitation guidelines to neonatal infants weighing less than 10 kg (22 lb). The resuscitation system includes two medical gas flowmeters, an integrated oxygen blender, airway pressure manometer, peak inspiratory pressure (PIP) control, positive end expiratory pressure (PEEP) control, a gas supply pressure alarm and T-piece resuscitator.

The SafeT T-Piece Resuscitator is a gas-powered emergency resuscitator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway. It is intended for use with neonates and infants weighing less than 10 kg (22 lb).

The SafeT T-Piece Resuscitator is a single-use, non-sterile, manually operated, gas-powered resuscitator for use with patients less than 10 kg (22 lb). It is a simple T-Piece resuscitator with a manometer and the ability to adjust Peak Inspiratory Pressure (PIP) and Positive End-Expiratory Pressure (PEEP). It incorporates a pressure relief valve to protect against excessive pressure. The T-Piece resuscitator can be connected to the patient via a face mask or tube. The subject device consists of several components: T-Piece patient valve with variable PEEP dial and integrated manometer, Adjustable inspiratory pressure controller, 40 cm H2O pressure relief valve, 7' Oxygen tubing with a red universal (Fits-all) connector, 20" x 10 mm circuit tubing, Face mask.

The MOVES® SLC™ is a portable computer controlled, electrically powered emergency ventilator intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. a. Suction The MOVES® SLC™ suction pump is intended for aspiration and removal of fluids, tissue (including bone), gases, bodily fluids or infectious materials from wounds or from a patient's airway or respiratory support system. b. Supplementary Oxygen The MOVES® SLC™ is intended to provide supplemental oxygen enriched air to patients that require supplemental oxygen. c. Patient Monitoring The MOVES® SLC™ is intended to monitor physiological parameters of patients and provide these parameters to a health care provider for interpretation in the form of physiological data and system alarms. Physiological data and system alarms will be available to the care provider from the monitor.

The MOVES® SLC™ (SLC) is an upgraded version of the cleared MOVES® SLC™ device (K140049), a portable multifunction patient support and monitoring system with the following capabilities: - Computer controlled, electrically powered circle ventilator intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. - Delivery of oxygen-enriched air that may be supplied from an external oxygen source or generated internal to the system with the on-board oxygen concentrator. - Patient monitoring functions including the following patient parameters: Pulse Rate, Noninvasive BP (NIBP), Invasive BP (IBP), SPO2, Temperature, Respiration Rate, CO2, and O2. - Suction/aspirator pump for medical suction procedures where secretions, blood and other body fluids must be removed through the application of continuous negative pressure. The MOVES® SLCTM is capable of operating under battery power or external AC supply. It includes a handle and mounting equipment that allows it to attach to a stretcher.

This Device is to be used by properly trained personnel to deliver emergency, short term, constant flow, pressure cycled ventilator support on patients weighing 10kg and above.

The VORTRAN® GO2VENT™ provides short term, constant flow, pressure cycled ventilatory support in either pressure control or pressure support modes on patients weighing 10kg and above. In the pressure support mode, the rate dial of the VORTRAN® GO2VENT™ is set so that the baseline pressure is above the set PEEP allowing the patient to initiate inhalation by drawing the baseline pressure down to the set PEEP. The device includes the pulmonary modulator (an exhalation valve that opens at PIP and closes at PEEP) and a patient connector tee to supply gas flow, entrain additional air, and provides a redundant pop-off valve for patient care. The working mechanism of the VORTRAN® GO2VENTTM consists of a moving diaphragm which adds or subtracts spring force when it is moved from a horizontal to a vertical position, the addition or subtraction of spring force will affect the PIP setting by 1~3 cm-H2O. The VORTRAN® GO2VENT™ will function in any position as long as the final adjustments are made in a secured position (strapped or taped to the patient). The VORTRAN® GO2VENT™ is not an ICU stand alone ventilator with multiple monitoring features. Set up and use of the VORTRAN® GO2VENT™ is simple. Set desired flow and adjust pressure dial to obtain desired I-time and/or tidal volume (see tidal volume chart in instructions), and adjust rate dial to obtain desired rate and I to E ratio.

o two e700, e600 and e500 are a time-cycled, volume-constant and pressure-controlled (only e700) emergency and transport ventilator designed for use in the pre-hospital, inter-hospital and transport settings. It is intended for use with adult, child, infant patients with a tidal volume from 50 ml (100 ml for e500) upwards who are in respiratory and/or cardiac arrest or respiratory distress and who require ventilatory support.

The proposed o_two e700, o_two e600 and o_two e500 are time-cycled, volume-constant and pressure controlled (o_two e700 only) emergency and transport ventilators. They are electronically controlled, pneumatically powered ventilators which can be run using AC/DC power adapter or an internal rechargeable Lithium Ion battery pack. The devices use a 4.3" TFT screen to display live ventilation parameters (Tidal and minute volumes, proximal airway pressure and breathing rate) as well as ventilation pressure & volume wave forms, ventilation modes, settings, alarm limits and battery status. The wide range of both visual and audible alarms provides the healthcare professional with warnings of any changes in patient or device parameters.

The T-Piece Resuscitator is a gas powered emergency resuscitator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway. It is intended for use with patients weighing greater than 10kg (>22lb).

The Mercury T-Piece Resuscitator is manually operated, gas powered resuscitator for use with patients greater than 10 kg (>22 lb). It is a simple T-piece, with a manometer and the ability to adjust Peak Inspiratory Pressure (PIP) and Positive End-Expiratory Pressure (PEEP). It incorporates a pressure relief valve for excessive pressure. The T-Piece Resuscitator can be connected to the patient via a face mask, Supraglottic airway or endotracheal tube.

The MOVES® SLC™ is a portable computer controlled electrically powered emergency transport ventilator intended to provide continuous or intermittent ventilatory support for the care of adults who require mechanical ventilation. MOVES® SLC™ is intended to deliver high inspired oxygen concentrations to spontaneously breathing patients who require elevated inspired oxygen. MOVES® SLC™ is intended to be used in a transport or emergency setting on adult patients who weigh between 40kg and 120kg. MOVES® SLC™ provides the following supplemental functions for patients that it is ventilating or supplying with supplemental oxygen: - Suction a. The MOVES® SLC™ suction pump is intended for aspiration and removal of fluids, tissue (including bone), gases, bodily fluids or infectious materials from wounds or from a patient's airway or respiratory support system. - Supplementary Oxygen b. The MOVES® SLCTM is intended to provide supplemental oxygen enriched air to patients that require supplemental oxygen. - c. Patient Monitoring The MOVES® SLC™ is intended to monitor physiological parameters of patients and provide these parameters to a health care provider for interpretation in the form of physiological data and system alarms. Physiological data and system alarms will be available to the care provider from the monitor.

The MOVES® SLC™ (SLC) is an upgraded version of the cleared MOVES® device (K093261), a portable multifunction patient support and monitoring system with the following capabilities: - . Computer controlled, electrically powered circle ventilator intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. - Delivery of oxygen-enriched air that may be supplied from an external oxygen . source or generated internal to the system with the on-board oxygen concentrator. - Patient monitoring functions including the following patient parameters: Pulse . Rate, Noninvasive BP (NIBP), Invasive BP (IBP), SPO2, Temperature, Respiration Rate, CO2, and O2. - Suction/aspirator pump for medical suction procedures where secretions, blood . and other body fluids must be removed through the application of continuous negative pressure. The MOVES® SLCTM is capable of operating under battery power or external AC supply. It includes a handle and mounting equipment that allows it to attach to a stretcher.