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The Dixtal DX-4100 Series Pulse Oximeter monitors are intended to provide continuous, non-invasive monitoring of functional arterial oxygen saturation (SpO2) and pulse rate in neonatal, infant, pediatric and adult patients, in environments where pulse oximetry is indicated for use, when in the judgment of a licensed medical practitioner/physician pulse oximetry is required.

The DX-4100 Series Pulse Oximeter Monitors is a modification to the Philips VM-1 (K081937) SpQz/CO₂ Monitor. The Monitor uses the same picoSAT IP44 SpO₂ engine as the VM-1, the same power supply, battery and technically the same display (same resolution as used in the VM-1) and has the same intended use as the VM-1 (Pulse Oximetry only). The Monitors will use the Dixtal (FDA cleared: K100020) Pulse Oximetry DX Series SpO2 Sensors. A second version of the DX-4100 Series Pulse Oximeter is equipped with the Philips receptacle thereby providing direct connection to the full line of sensors as indicated for the VM-1. Accuracy testing included with the sensor submission was performed with the Philips VM-1 monitor.