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The Model 2001 Pulse Oximeter is intended to provide continuous, non-invasive monitoring of functional arterial oxygen saturation and pulse rate units in neonatal, pediatric and adult patients in hospital-type facilities and intra-hospital transport environments such as the operating room, emergency department and intensive care units. The Model 2001 and its sensors are intended to be used by trained operators when pulse oximetry monitoring is required in the judgement of a physician.

The Model 2001 Pulse Oximeter is designed for continuous, non-invasive monitoring of the functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. Oxygen saturation is measured with ratiometric technique using red and infrared absorbance of oxy- and deoxyhemoqlobin and pulse rate is measured using the time between successive pulses. The O2 saturation sensors are already legally marketed as accessories to the Model 520A monitor. The Model 2001 displays digital values of SpO2 and pulse rate as well as a graphic display of the plethysmogram. The Model 2001 monitor consists of a dual microprocessor based data acquisition system that measures oxygen saturation data. The firmware for the primary microprocessor performs the functions of the existing Model 520A including data acquisition, display, trending and communications with external devices. The firmware for the second microprocessor, a digital signal processor, performs the filtering, pulse rate and saturation calculations of the existing algorithms and additional calculations which analyze the incoming signals and perform noise reduction on that signal when the presence of noise is detected.

The intended use of the CO2,SMO Plus! with NICO is to provide: - cardiac output monitoring via the method of partial rebreathing in adult patients receiving . mechanical ventilation during general anesthesia and in the intensive care unit (ICU). - . spirometric, carbon dioxide and pulse oximetry monitoring in neonatal, pediatric and adult patients during general anesthesia and in the intensive care unit (ICU) and the emergency department (ED). Separate flow sensors and CO2 airway adapters are provided for pediatric/adult and neonatal use. It is intended to be used by trained operators when spirometric, capnographic, pulse oximetry, or cardiac output monitoring is indicated in the judgement of a physician. It is intended that: - the neonatal flow and combined CO /flow sensors be used with ET tube sizes less . than or equal to 4 mm and - the pediatric/adult flow and combined CO2/flow sensors be used with ET tube sizes # greater than 4 mm or with 22 mm ID breathing circuit devices such as a mouthpiece. The fittings of the flow sensors and CO2 airway adapters comply with ISO [5356-1: 1987 (E)]. The flow sensors and CO2 airway adapters may be used in conjunction with endotracheal tubes, face masks, and breathing circuit devices that also comply with the same fitting specification. The flow sensors, combination CQ2fflow sensors, single patient use CO, airway adapters and valve assembly are single patient use devices. The CO2SMO Plus! with NICO can calculate additional parameters such as cardiac output, pulmonary capillary blood flow, cardiac index, stroke volume and systemic vascular resistance. The use of the CO2SMO Plus! with NICO is contraindicated in patients in which a small rise (3-5 mmHg) in their arterial partial pressure of CO, level cannot be tolerated.

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