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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 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.

The OxiMax™ NPB-40 handheld pulse oximeter is indicated for continuous or spot check monitoring of functional arterial oxygen saturation (SpO2) and pulse rate of adult, pediatric and neonatal patients in hospital type facilities, transport and mobile environments as well as in the home care environment.

The OxiMax NPB-40 is a handheld, battery powered pulse oximeter used for monitoring of pulse rate and saturated oxygen in arterial blood. The OxiMax NPB 40 include the addition of audible alarms, addition of keys and display icons in the user interface board to access the alarm settings and the OxiMax in-sensor data features. The OxiMax NPB-40 also has menu features to allow the user to set the time, date and measurement alarm limits

The Puritan Bennett GoodKnight 425ST is indicated for use in treating obstructive sleep apnea (OSA) in spontaneously breathing patients weighing over 30 kg within a homecare and hospital environment.

The GoodKnight 425ST is designed to deliver Positive Airway Pressure between 3 and 20 cmH2O in CPAP mode or between 3 and 25 cmH2O in bi-level mode (EPAP maximum 20 cmH2O). The GoodKnight 425ST can be powered either by AC mains (100 VAC to 240 VAC nominal) or by an external 12 VDC battery. The blower motor nominal voltage is 13 VDC. The GoodKnight 425 is doubleinsulated so that grounding is not required. The GoodKnight 425ST is set up for use by the homecare dealer using the Clinician Manual provided. The devices are operated according to the instructions contained in the Patient Manual. The GoodKnight 425ST rely on a microprocessor for setting and viewing various control parameters and turning features on and off. The microprocessor is also required for the treatment of various signals from the devices including signals relating to patient cycle detection. Pressure delivery for the GoodKnight 4253T is regulated by a pressure sensor which monitors both ambient and output pressure and provides feedback to the control system. The GoodKaight 425ST uses the same pass over humidifier and interfaces as those approved for use with the GoodKnight 425. The GoodKnight 425ST tubing is equivalent to that of the GoodKnight 425. The GoodKnight 425ST can also be connected to a computer via an RS232 serial port. The device can be configured from the computer using the SilverLining™ software which is required for downloading and displaying compliance data stored in the device memory. The GoodKnight 425ST is not for use in life-supporting or life-sustaining situations. The devices and/or their accessories are not intended for sterile use. The GoodKnight 425ST is for multiple use. Accessories such as the patient circuit and nasal masks are for single patient use. The GoodKnight 425ST is for use by prescription only and display the appropriate labeling. The GoodKnight 425ST is for use in a hospital and homecare environment. The GoodKnight 425ST does not contain any drugs or biological products as components. However, the devices can be used to provide the patient with supplemental oxygen. The GoodKnight 425ST is not part of a kit. The GoodKnight 425ST uses software to set the various device parameters such as the prescription pressure and the ramp starting pressure.

The Reprocessed Oxisensor II and OxiMax Sensors are intended for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. They are intended for use 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, intra-hospital transport, and home environments.

The Reprocessed Nellcor Oxisensor and OxiMax Sensors are designed for use with Nellcor and Nellcor-licensed pulse oximetry monitors that provide continuous noninvasive measurement of pulse rate and arterial oxygen saturation. The sensor contains three optical components: two light emitting diodes (LEDs) that serve as light sources and one photodiode that acts as a light detector. Both the LEDs and the photodiode are contained within a laminated envelope with an adhesive bandage for attachment to a patient. Attached to a laminated envelope is a sensor cable which terminates in a connector element that connects to the oximeter. The sole difference between the OxiMax sensors and the Oxisensor II sensors is the OxiMax sensors each contain 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.