Nellcor™ Pulse oximetry

References

The Nellcor™ pulse oximetry monitoring system should not be used as the sole basis for diagnosis or therapy and is intended only as an adjunct in patient assessment.

† Oxygen saturation accuracy can be affected by certain environmental, equipment, and patient physiologic conditions (as discussed in the operator’s manual for the monitor) that influence readings of SpO₂. Please consult the IFU and manual for full safety information.

1. PMB05N (MFR): 10096850A00 REPORT, CLINICAL, ACCURACY AND LOW SAT, REPEAT, CONNERY OEM: PMB10N (LP100): RE00085099 Verification Test Report, Sensor Accuracy, Oxicable including simulated patient data RE00101824 Rev. A PMC10UB305N Oxicable Low Saturation Accuracy Study, Clinical Study Report. NELL1: 10011350 (N600x/Nell1 FE) - Clinical Summary Report for N600x including a validation study with Nell-1 (MP100-06) oximeter with MaxA, MaxN, and MaxFast at 60-80% saturation range.

2. PMB05N (MFR): 10096394 - Clinical Report, Abbreviated Sensor Line, Connery (P3.1) in N-600x including validation at 70-100% saturation range with MaxA, OxiCliqA, SCA, DS100A, MaxFast, and DYSEPMB10N (LP100): 10143258 - Clinical Report, Oxicable (LP100 embedded). Abbreviated Sensor Line including the validation at 70%-100% saturation range with MaxA, MaxFAST, SCA, OxicliqA, DS100A, DYS-ERE00105732, SpO2 Accuracy Clinical Report of USB Pulse Oximetry Monitor Interface Cable with FlexMax Reusable SpO2 Sensor via Reference CO-Oximetry. 10028895 - MP100_06 (Nell 1 equivalent) - Clinical Summary Report including validation of accuracy of MP100-06 with Max AL, DS100A, D-YSE, OxiCliq, SC-A and MaxFast.

3. Based on internal reports: RE00083396 - Verification report, motion pulse rate accuracy, Oxicable. 10143241 - Clinical report, Springboard, Oxicable motion study. RE10011350- Clinical Summary Report, Jupiter, N600x including reference to clinical testing report "Non Invasive Controlled Acute Hypoxia Study – Jupiter: Validate P3 .2 w / MAX-A Gold Sensors during Standard Motion vs. Gold MAX-A w / N-595 (09-20-05 ). N595: 10047614 - Saturation and Pulse Rate Comparative performance of the N-595 During Combined Motion and Low Perfusion (Clinical report including the validation of motion and low perfusion conditions combined with N-595 /Max A ). 10035078 - N595 Standard Motion Study Summary Report Saturation and Pulse Rate Accuracy of the N595 During Standard Motions with N595 /Max A and N395 /D25.

4. Brostowicz HM, Khodayar Rais-Bahrami K. Oxygen saturation monitoring in the neonatal intensive care unit: evaluation of a new alarm management. Presented at: American Academy of Pediatrics National Conference & Exhibition; October 17-20, 209; Washington D .C.