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The Nonin Medical 3250 Finger Pulse Oximeter is a small, portable device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate of individuals who are well or poorly perfused under no motion conditions for medical use without a prescription. It is intended for spot-checking of individuals 18 years and older with finger thickness between 0.8-2.5 cm (0.3-1.0 inch). It is not intended for the diagnosis or screening of lung disease, for use in treatment decisions, and should only be used for making heathcare decisions under the advice of a healthcare provider.

Model 3250 Pulse Oximeter is a small, lightweight, portable, battery operated, digit pulse oximeter that displays numerical values for functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate and is intended for over-the-counter use. The device measures the absorption caused by the pulsation of blood in the vascular bed, which are used to determine oxygen saturation and pulse rate. Light emitting diodes (LEDs) are contained within the device along with the photo detector, which is on the opposite side of the probe from the LEDs. The SpO2 and pulse rate are displayed on the LCD display of the device. The LCD also provides a visual indication of the pulse signal, while blinking at the corresponding pulse rate. The display will indicate poor pulse quality that may affect the readings. All associated electronics and the microcontrollers are within the sensor, which is activated by inserting a patient's digit. This simple operation activates the internal circuitry automatically upon application. The Model 3250 includes a Bluetooth radio to send real time oximeter readings to a host device. The Model 3250 features a Bluetooth LE version 4.0 radio to ease the connectivity setup configuration with options to implement secure connections for the point-to-point data connection. This oximeter uses ISP3, Nonin's core signal processing technology software.

The Multi-Sensing Oximetry System when used with Model 8330AA sensor, is intended for noninvasive measuring of functional oxygen saturation of arterial hemoglobin (%SpO2), carboxyhemoglobin saturation (%COHb), and pulse rate. The measurements may be multiple spot-checks to observe change and/or continuous monitoring. This device is not meant for sole use in clinical decision making; it must be used in conjunction with additional methods of assessing clinical signs and symptoms. • For %SpO2 and pulse rate, the multi-sense system is intended for use in professional healthcare facilities, mobile, and EMS settings in adult and pediatric patients (> 66 lbs/30 kg). • For %COHb, the multi-sense system is intended for use in professional healthcare facilities in adult and pediatric patients (> 66 lbs/30 kg). This device should not be used to screen, diagnose or make treatment decisions related to suspected carbon monoxide poisoning.

Nonin Medical's Multi-Sensing Oximetry system, when used with Model 8330AA reusable finger clip sensor, is based on Nonin's SenSmart™ technology platform, displays (%COHb), pulse oxygen saturation (%SpO2), and pulse rate (PR) data transmitted from one channel of data through a direct connection of a signal processor to the monitor. The model 8330AA sensor provides real time data output of COHb, SpO2, and PR.

Model 8203CA The Model 8203CA single-patient use, non-sterile, disposable sensor is intended for use as an adjunct monitor of trends in regional hemoglobin oxygen saturation of blood underneath the sensor of adult or pediatric patients weighing greater than 88 pounds (40 kilograms). The sensor may be repositioned or replaced with another 8203CA sensor without baseline reestablishment. It is intended for use in environments including the operating room, surgical recovery, critical care, emergency room, long-term care, and mobile environments. Model 8204CA The Model 8204CA single-patient use, non-sterile, disposable sensor is intended for use as an absolute real-time adjunct monitor of regional hemoglobin oxygen saturation of blood underneath the sensor of adult and pediatric patients weighing greater than 88 pounds (40 kilograms). The sensor may be repositioned or replaced with another 8204CA sensor without baseline re-establishment. It is intended for use in environments including the operating room, surgical recovery, critical care, emergency room, long-term care, and mobile environments.

The SenSmart Model 8203CA Regional Oximetry Sensor (Model 8203CA) and SenSmart Model 8204CA Regional Oximetry Sensor (Model 8204CA) are single-patient use, non-sterile disposable regional (tissue saturation) sensors intended for use with the Nonin Medical Model X-100 SenSmart Regional Oximetry System (Model X-100). The proposed devices are also compatible with the Nonin Model 7600 Regional Oximeter (Model 7600).