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The Nellcor OxiMAX N-600X Pulse Oximetry System with N-600X Pulse Oximeter and OxiMAX Sensors and Cables is indicated for prescription use only for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate. The N-600X Pulse Oximeter is intended for use with neonatal, pediatric, and adult patients during both no motion conditions and for patients who are either well or poorly perfused, in hospital-type facilities, intra hospital transport, and home environments. The N-600X with SPD feature is intended for use on adults to detect patterns of desaturation that are indicative of repetitive reductions in airflow through the upper airway and into the lungs. For Covidien Nellcor Bedside Respiratory Patient Monitoring System with Respiration Rate Software: The Nellcor Bedside Respiratory Patient Monitoring System is a portable pulse oximeter intended for prescription use only as a continuous non-invasive monitor of arterial oxygen saturation (SpOz) and pulse rate of adult, pediatric, and neonatal patients during both no motion conditions and for patients who are well or poorly perfused. The monitoring system is intended for use in hospitals, hospital-type facilities, and during intra-hosport. The OxiMax SPD™ Alert (SPD) feature is intended only for facility-use care of adults to detect patterns of desaturation indicative of repetitive reductions in aifflow through the upper airway and into the lungs. The Respiration Rate parameter, when used in conjunction with the Nellcor Bedside Respiratory Patient Monitoring System and Nellcor Respiratory Sensor, is intended to be used for the continuous non-invasive monitoring of respiration rate in adult patients in hospitals and hospital-type facilities. The Nellcor Bedside SpOz Patient Monitoring System is indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The Nellcor Bedside SpO2 Patient Monitoring System is intended for prescription use only with neonatal, pediatric, and adult patients, during both no motion and motion conditions and for patients who are well or poorly perfused, in hospitals, hospital-type facilities, and intra-hospital transport.

The OxiMAX family of pulse oximeters (including the N-600X, Nellcor Bedside Respiratory Patient Monitoring System, and Nellcor Bedside SpO2 Patient Monitoring System) provides continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate. The N-600X, Nellcor Bedside Respiratory Patient Monitoring System, and Nellcor Bedside Sp02 Patient Monitoring System are designed for continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate using OxiMAX pulse oximetry sensors and the DOC-10 cable. The Nellcor Bedside Respiratory Patient Monitoring System, Bedside SpO₂ Patient Monitoring System and the OxiMAX N-600X Pulse Oximetry System, the Nell-1 family of pulse oximeters, are technologically identical. They have the same oximetry PCBA and software.

The Vital Sync™ System is intended for the display and recording of multiple physiological parameters of adult, pediatric and neonatal patients. It is not intended for alarm notification, nor is it intended to control any of the independent bedside devices it is connected to. The Vital Sync™ System displayed parameters are listed on the following pages. WARNING: The Vital Sync™ System is not an active patient monitoring system. It is intended to supplement and not to replace any part of the hospital's device monitoring.

The Vital Sync™ System is being extended to offer additional device compatibility and parameter display. The design features of the subject Vital Sync™ System are substantially equivalent to the design features of the predicate Vital Sync™ system.

The 840 Ventilator System with Expanded NeoMode Option provides continuous ventilation to patients requiring respiratory support. The 840 Ventilator System with Expanded NeoMode Option, is intended for patients with an Ideal Body Weight (IBW) as low as 0.3 kg and for use in a wide variety of clinical conditions. The 840 Ventilator System with Expanded NeoMode Option is intended for use in hospitals and hospital-type facilities. It may be used during hospital and hospital-type facility transport provided that electrical power and compressed gas are supplied.

The PB 840 Ventilator is a dual-microprocessor-based, touch-screen controlled, critical care ventilator intended to provide continuous ventilation for neonate to adult patients (with expanded NeoMode Option) or infant to adult patients (with no Option) who require either invasive ventilation or non-invasive ventilation. The 840 Ventilator Expanded Neomode Option includes the software enhancements that lower the ideal body weight (IBW) from 0.5kg to 0.3kg and provides the user an option to lower the tidal volume to 2mL. The ventilator determines values for operational variables and allowable settings based on breathing circuit type and IBW. The software controls prevent inadvertent mismatching of patient size and breathing circuit type. The 840 Ventilator Expanded Neomode Option is available as an integrated part of the 840 Ventilator or as separate software upgrade kit.

The 840 Ventilator System with Leak Compensation Option is intended to provide continuous ventilation to patients requiring respiratory support. The device is intended for patients with an Ideal Body Weight (IBW) as low as 0.5 kg (with NeoMode option) to adult, and for use in a wide variety of clinical conditions. The 840 Ventilator System with Leak Compensation Options is intended for a wide range of patients ranging from neonate to adult (V- 5-2500 mL with NeoMode) or from infant to adult (V-25-2500 mL). The 840 Ventilator System with Leak Compensation is intended for use in hospital and hospital-type facilities. It may be used during hospital and hospital-type facility transport provided that electrical power and compressed gas are supplied.

The Leak Compensation Option enables the 840 Ventilator System to automatically detect and characterize gas flow that leaves the breathing circuit through air leak(s) and does not return to the 840's exhalation valve for inclusion in the displayed exhaled spirometry. LC does not makeup for lost delivered volume but does add the necessary additional flow into the breathing circuit to optimize breath triggering and cycling functions as well as maintain the set PEEP, and display clinically valuable leak-related parameters for consideration by the clinician. The Leak Compensation feature is implemented on the 840 Ventilator through additional functionality in software and by use of the existing User Interface panel. No hardware or firmware changes or additions were required. The 840 Ventilator is a dual-microprocessor controlled, critical care ventilator intended to provide continuous ventilation for neonate to adult (with NeoMode Option) or infant to adult (without NeoMode Option) patients who require either invasive ventilation or non-invasive ventilation (via face mask).

The PB 540 Ventilator is indicated for the continuous or intermittent mechanical ventilatory support of patients weighing at least 5 kg who require mechanical ventilation. The ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. Specifically, the ventilator is applicable for adult and pediatric patients who require the following general types of ventilatory support, as prescribed by an attending physician: - Positive Pressure ventilation - Assist/Control, SIMV, or CPAP modes of ventilation - Breath types including Volume, Pressure Control and Pressure Support. The ventilator is suitable for use in institutional, home, and transport settings. It is not intended for use as an emergency transport ventilator.

The PB 540 Ventilator gas delivery system is composed of a flow generator capable of supplying a sufficient range of flows and pressures that is then controlled by a three-way valve enabling piloting of the expiration valve. The flow generator is a low-inertia micro-turbine driven by a brushless electric motor and the valve is a proportional electronically driven valve. These two actuators are controlled according to specific control algorithms by a microprocessor receiving information from the pressure and flow sensors built into the ventilator.

The Legendair XL2 is indicated for the continuous or intermittent mechanical ventilatory support of patients weighing at least 5 kg who require mechanical ventilation. The ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. Specifically, the ventilator is applicable for adult and pediatric patients who require the following general types of ventilatory support, as prescribed by an attending physician: . Positive Pressure ventilation Assist/Control, SIMV, or CPAP modes of ventilation . Breath types including Volume, Pressure Control and Pressure Support. ◆ The ventilator is suitable for use in institutional, home, and transport settings. It is not intended for use as an emergency transport ventilator.

The LEGENDAIR® XL2 ventilator is composed of an airflow generator capable of supplying a range of flow rates and pressures and a valve enabling piloting of the expiration valve. The operation of the device is based on a self-adapting drive system governed by a closed loop flow generator. The speed of the flow generator (turbine) is servo-controlled to the patient pressure signal or the inspired flow signal. The ventilation modes available are: - -Pressure Support Ventilation - . Pressure Support Ventilation with Back Up Rate - CPAP mode - - Pressure Controlled Ventilation ﮯ - Pressure Assisted Controlled Ventilation - - Volume Controlled Ventilation - - Volume Assisted Controlled Ventilation - - Synchronous Intermittent Mandatory Ventilation with either volume or pressure ﮮ targeted mandatory breaths

The Nellcor® DuraMax® reusable oximetry sensor is indicated when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for patients weighing 40 kg or more.

The DuraMax is a reusable sensor, sized appropriately to fit the digit of a pediatric or adult patient weighing 40 kg or more. The DuraMax sensor consists of an internal frame containing the optical components and flexible circuit encapsulated in a synthetic, latex-free rubber overmold. The DuraMax sensor plug contains a memory chip carrying information about the sensor which the oximeter needs for correct operation, including Advanced Signal Evaluation, Intention and data set revision, and sensor model. The DuraMax sensor is compatible with Nellcor and other monitors incorporating either Nellcor R-Cal or OxiMAX (DigiCal) oximetry technology.

The Nellcor OxiMax N-600x Pulse Oximeter is indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The Nellcor OxiMax N-600x Pulse Oximeter is intended for use with neonatal, pediatric, and adult patients, and for patients who are well or poorly perfused, in bospitals, hospital-type facilities, intra-hospital transport, and home environments. For prescription use only

The OxiMax N-600x Pulse Oximeter is a modification OxiMax Pulse Oximetry System with N-595 Pulse Oximeter and OxiMax Sensors and Cables. The N-600x is designed for continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate using OxiMax pulse oximetry sensors and the DOC-10 cable. The N-600x Pulse Oximeter displays digital values of SpO2 and Pulse Rate. Pulse Amplitude is displayed by means of a "blip bar" presentation or plethysmographic waveform. The N-600x can be powered by an internal power supply operating on AC from a standard electrical utility receptacle (manually switchable from 115V to 230V) or alternatively by an internal 6V rechargeable sealed lead-acid battery. The OxiMax N-600x Pulse Oximeter is intended for prescription use with adult, pediatric and neonatal patients in hospitals, hospital-type facilities, intra-hospital transport, and home environments.

The Nellcor® OxiMax® NeoMAX adhesive forchead reflectance sensor is indicated for single patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for neonatal and pediatric patients (≤ 40 kg).

The OxiMax NeoMAX is a sterile, latex-free, single patient use forehead sensor, sized appropriately to fit the forehead of a neonatal or pediatric patient. The OxiMax NeoMAX sensor contains a memory chip carrying information about the sensor which the oximeter needs for correct operation, including in-sensor data. Advanced Signal Evaluation, lot code and data set revision, and sensor model. The OxiMax NeoMAX sensor is compatible with OxiMAX monitors.

The Nellcor OxiMax Pulse Oximetry Sensors, models MAX-A, MAX-AL, MAX-N, MAX-P, MAX-I and MAX-FAST are indicated for single patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for patients in the sizes indicated in the respective sensor directions for use.

Nellcor OxiMax Pulse Oximetry Sensors, models MAX-AL, MAX-AL, MAX-P, MAX-I and MAX-FAST are designed for continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate in conjunction with a Nellcor pulse oximeter. Nellcor OxiMax Pulse Oximetry Sensors, models MAX-A, MAX-AL, MAX-N, MAX-P, MAX-I and MAX-FAST are intended for prescription use with adult, pediatric and neonatal patients in hospitals, hospital-type facilities, intra-hospital transport, and home environments. These OxiMax sensors each contain a memory chip carrying information about the sensor which the oximeter needs for correct operation including sensor model, Advanced Signal Evaluation, and data set revision. The memory chip is also cable of storing including in-sensor data when connected to an OxiMax-capable monitor, and lot code.