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When used with a compatible patient monitor or a pulse oximeter device, Solaris Medical Technology, Inc. reusable & disposable SpO2 sensors are intended to be used for continuous, non-invasive functional arterial oxygen saturation (SpO2) and pulse rate monitoring. Solaris Medical Technology, Inc. reusable multi-patient use SpO2 Soft Sensors, reusable multi-patient use SpO2 Finger Sensors, and disposable single patient use SpO2 Soft-finger Sensors are for use with adult/pediatric patients weighing greater than 40kg. Solaris Medical Technology, Inc. disposable single patient use SpO2 Adhesive Sensors are for use with adult patients weighing greater than 40kg, pediatric patients weighing 10 - 40 kg, and infant (non-neonatal) patients weighing 3 - 15 kg. Prescription device.

Solaris Compatible Reusable and Disposable SpO2 Sensors (Solaris Sensors) are compatible sensors for use with major types of patient monitors and oximeter devices as listed above. Solaris Sensors employ non-invasive electro-optical means to determine the light absorption of functional arterial hemoglobin. The sensor contains three optical components: two light emitting diodes (LED) that serve as light sources and one photodiode that acts as a light detector. The LED and photodiode are contained in the sensor housing. Four types of sensor housings are described in this submission: - Reusable soft finger sensor comprised of an integrated silicone rubber tube. - Reusable finger clip sensor with rigid halves and silicone pads - Disposable soft-digit sensor with flexible silicone housing - Disposable adhesive sensors constructed of a medical tape laminate Each sensor has unique labeling and specifications designed for compatibility with the specific monitor manufacturer (Nellcor, Nonin, HP/Philips, BCI).

The Solaris NT1 Handheld Pulse Oximeter with Sensor Accessories is a non-invasive spot-check, functional arterial oxygen saturation and pulse rate monitor. The device operates on battery power using SOLARIS reusable Sp02 sensors. The device is intended for pediatric and adult patients and can be used in hospital clinical areas by medical and nursing staff. The Solaris NT1A Handheld Pulse Oximeter with Sensor Accessories is a non-invasive spot-check or continuous monitoring, functional arterial oxygen saturation and pulse rate monitor. The device has data storage and data transfer functionality via a USB hub. The device operates on battery power using SOLARIS reusable Sp02 sensors. The device is intended for pediatric and adult patients and can be used in hospital clinical areas by medical and nursing staff.

The subject SOLARIS NT1 and NT1A Handheld Pulse Oximeters measure pulse rate and oxygen saturation. The signals are converted into digital data and processed; the pulse oximeter examines the data and displays the data. The subject pulse oximeters also provide operating control for the user. The pulse oximeters are intended for use in spot checking; the NT1A model is intended to both spot check and perform continuous monitoring. The pulse oximeters can be used in hospital clinical areas such as general wards to provide additional information to the medical and nursing staff about the physiological condition of the patient. The subject devices are intended to be used under supervision by clinical personnel. The intended location of use is clinics. The subject pulse oximeters provide a rapid indication of a patient's level of oxygenation which reflects the effective ventilation. The NT1A Pulse Oximeter with alarm allows continuous and instantaneous monitoring of SpO2 and both the NT1 and NT1A Pulse Oximeters reduce the need for arterial puncture and bloodgas analysis.

Solaris NT1 and NT1A Handheld Pulse Oximeters with sensor accessories are non-invasive spot-check, oxygen saturation and pulse rate monitors. They operate on battery power using SOLARIS reusable Sp02 sensors for pediatric and adult patients.

The subject SOLARIS NT1 and NT1A Handheld Pulse Oximeters measure pulse rate and oxygen saturation. The signals are converted into digital data and processed; the pulse oximeter examines the data and displays the data. The subject pulse oximeters also provide operating control for the user. The pulse oximeters are intended for use in spot checking; the NT1A model is intended to both spot check and perform continuous monitoring. The pulse oximeters can be used in hospital clinical areas such as general wards to provide additional information to the medical and nursing staff about the physiological condition of the patient. The subject devices are intended to be used under supervision by clinical personnel. The intended location of use is clinics. The subject pulse oximeters provide a rapid indication of a patient's level of oxygenation which reflects the effective ventilation. The NT1A Pulse Oximeter with alarm allows continuous and instantaneous monitoring of SpO2 and both the NT1 and NT1A Pulse Oximeters reduce the need for arterial puncture and bloodgas analysis. The subject pulse oximeters are composed of two boards, a main control board and a physiological singal processing board. The main control board is composed of a LED display and its control and driver, data memory, audio circuit, UART communication interface, and DC/DC circuits. The physiological processing board is composed of a SpO2 sensor control and IR/RED LEDs driver, data collection, signal processing algorithm execution, UART communication interface and DC/DC circuits. The oximeter is housed in a single package. The main components of the assembly are listed as following - Main Board . - SpO2 Module . - Key Pad . - Batterv ●

Solaris Medical Technology, Inc. SpO2 sensors are indicated for use in continuous, non-invasive monitoring of arterial oxygen saturation and pulse rate for patients weighing more than 40 kg.

Solaris Compatible Reusable Adult SpO2 Finger Sensors (Solaris Sensors) are compatible reusable sensors for use with major brands of patient monitors and oximeter devices. Solaris Sensors are electro-optical sensors which function without skin penetration, electrical contact, or heat transfer. The sensors use optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the patient monitor or oximeter device. The sensor contains three optical components: two light emitting diodes (LED) that serve as light sources and one photodiode that acts as a light detector. The LED and photodiode are contained in silicon rubber pads.