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Models: U403-91, U410-91 Unimed Reusable Finger Clip SpO2 Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult patients weighing greater than 30 kg. These devices are for prescription use only.

The subject devices, Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series), are fully compatible reusable sensors for use with Philips Itellivue MP30. These sensors are supplied non-sterile. The subject sensors (Models: U403-91 and U410-91) consist of a plug/connector (Philips D8 sensor connector), a cable, and a patient-contacting (finger clip) where light-emitting diode (LED) and photodetector (PD) are located. The subject sensors share the same principle of operation as the predicate device for functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) measurements. Patient-contacting materials of the subject sensors include ABS, silicone, and TPU, all of which have been qualified against biocompatibility requirements in ISO 10993-5, ISO 10993-10, and ISO 10993-23.

Unimed Reusable Finger Clip SpO2 Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult patients weighing greater than 30 kg and pediatric patients weighing 10-50 kg. These devices are for prescription use only.

The subject devices, Unimed Reusable Finger Clip SpO2 Sensors, are fully compatible reusable sensors for use with monitors that incorporate Masimo technology. These sensors are supplied non-sterile. The subject sensors consist of a plug/connector (U403-125 and U103-125 with M8 sensor connector, and U403-254 and U103-254 with M10 sensor connector), a cable, and a patient-contacting (finger clip) where light-emitting diode (LED) and photodetector (PD) are located. The subject sensors share the same principle of operation as the predicate device for functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) measurements. Also, the subject sensors have identical material composition and performance characteristics to the predicate device.

The pulse oximeter is indicated for the noninvasive spot checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult and pediatic (≥10Kg) patients during both no motion and for patients who are well or poorly perfused. Pulse Oximeter is intended for hospitals, hospital-type facilities, home environments.

The Pulse Oximeter is a small, lightweight, portable, digit pulse oximeter that displays numerical values for functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR) and perfusion index (PI) by measuring the absorption of red and infrared light passing through perfused tissue. It indicated for adult and pediatric (≥10Kg) patients during both no motion and motion conditions, and for patients who are well or poorly perfused. The device consists of probe, electronic circuits, OLED/LED display (differentiated by models) and plastic housing which powered by two alkaline AAA batteries.

The CO2 Mainstream Module is intended to provide carbon dioxide monitoring system during anesthesia/recovery in Emergency Medicine/Transport or Respiratory care.

The CO2 Mainstream module is a non-dispersive infrared gas analyzer with an auto-zero adjustment systemand gain control. The operation of the CO2 Mainstream module is based on CO2 energy absorption rates. CO2 molecules absorb infrared light energy of specific wavelengths, with the amount of energy absorbed being directly related to the CO2 concentration. When an IR light beam is passed through a gas sample containing CO2, the electronic signal from the infrared sensor (which measures the remaining light energy), can be obtained. This signal is then compared to theenergy of the IR source, and calibrated to reflect CO2 concentration in the sample accurately. Calibration is performed using the infrared sensor's response to a known concentration of CO2 stored in the module's memory. The circuit module retains the atmospheric absolute pressure sensors and control of the pressure sensor. Modules can measure atmospheric pressure, and atmospheric can compensate the calculation for the concentrations of carbon dioxide, which improves the design accuracy. The module then determines CO2 concentration in the breathing gases by measuring the amount of light absorbed by these gases. EtCO2 displays a numerical value in millimeters of mercury (mmHg), percent(%), or kilopascals (kPa). In addition, a CO2 waveform (Capnogram) may be displayed, which is a valuable clinical tool that can be used to assess patient airway integrity and proper endotracheal tube placement. Respiration rate is calculated by measuring the time interval between detected breaths.