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The PMD-200 with the Nociception Level (NOL) Index is indicated for use in a clinical setting that requires assessment of changes in nociception levels in adult patients under general anesthesia receiving opioid or opioid-sparing analgesia as part of their care. The PMD-200 should be used as an adjunct to clinical judgment. Clinical judgment should always be used when interpreting the NOL index in conjunction with other available clinical and vital signs.

The PMD-200 (device) is a nociception monitoring system which assists assessment of anaesthetized patient's physiological response to noxious stimuli and helps tailor analgesic administration to the patient's actual response to painful stimuli. The device provides quantification of the patient's response to noxious stimuli with the nociception level index (NOL). The PMD-200 system consists of 4 main components: - Monitor acquisition and display of physiological raw data signals and NOL . index and trend graph. - . Software includes two main components: - Calculation of the NOL index based on physiological parameters extracted from raw data signals. - O User interface displays physiological raw data signals, NOL index and trend graph. - Finger probe -includes the following sensors: . - Photoplethysmogram (PPG or Pleth) o - · Thermistor for peripheral temperature (TMP) - · A 3-axis accelerometer for movement (ACC or Movement). - Connectors for the Galvanic skin response sensor (GSR or Conductance) - Single use sensor (connected to the finger probe) includes the following sensor: . o Bio-impedance Galvanic skin response sensor (GSR or Conductance) The NOL index is a relative, non-linear measure with a range of 0-100, where 0 represents no pain /nociceptive response and 100 represents extreme pain/nociceptive response. The NOL index and trend are intended to support clinical decisions concerning the administration of analgesic medications.