Device Dossier

Analyser software, application program

Device Dossier for Analyser software, application program (Analyser software, application program, Class IIb, sponsor Medtronic). ARTG record, intended…

Intended purpose

The SPD (Saturation Pattern Detection) is a feature upgrade to the Oximax N600x pulse oximeter software. The Saturation pattern detection with OXIMAX SPD Technology feature is intended only for facility use care of adults to detect patterns of desaturation indicative of repetitive reductions in airflow through the upper airway and into the lungs. The SPD feature is a means of evaluating the SPO2 information being collected by the oximeter, analogous to the threshhold or satseconds alarm features currently available on the Oximax N600X pulse oximeter. (The Oximax N600x pulse oximeter is intended for prescription use only neo natal, paediatric and adult patients who are well or poorly perfused in hospitals , hospital type facilities, intra hospital transport and home environments.)

TGA Public Summary