Overview:

Nellcor™ sensor products with OxiMax™ technology are remanufactured to meet the same quality specifications as new Nellcor sensors.

When a hospital chooses remanufactured Nellcor™ sensors from Covidien, it is purchasing high-quality products at significant cost savings. The sensors are remanufactured to original quality specifications.

Because remanufacturing Nellcor sensors cuts the cost of medical supplies, reduces medical waste and helps the environment, the Covidien Nellcor Sensor Remanufacturing Program makes good business sense.

Features:

Features of Nellcor™ Remanufactured Sensors with OxiMax™ Technology

 

For every qualifying sensor returned, the customer can purchase one remanufacturable sensor (i.e., 1 X credit calculation).*

* Some accounts have been grandfathered into 1.5X.

 

Specifications

Specifications:
NellcorTMSensors: Accuracy Specifications
Spo2(70%-100%) New1 Remanufactured*2
Adhesive A/P/I/AL ± 2 digits ± 2 digits
Adhesive Neonate ± 2 digits ± 2 digits
Perfusion Range 0.03% - 20% 0.03% - 20%
Low Perfusion ± 2 digits ± 2 digits
Pulse Rate New1 Remanufactured2
Pulse Rate 20 -250 bpm ± 3 digits 20 - 250 bpm ± 3 digits
Low Perfusion 20 -250 bpm ± 3 digits 20 -250 bpm ± 3 digits

†When used with NellcorTM pulse oximeters. For use with other manufacturers’ monitors, obtain relevant information from those manufacturers. All accuracies are expressed as ± “X” digits. Pulse oximeter equipment measurements are statically distributed; about two-thirds of pulse oximeter measurements can be expected to fall in this accuracy range.

*Remanufactured sensors have only been validated in the 70% - 100% SpO2 range. Neonate specifications are shown for OXIMAX MAX-N sensors with the N-600x.

Clinical functionality of the MAX-N sensor has been demonstrated on a population of hospitalized neonate patients. The observed SpO2 accuracy was 2.5% in a study of 42 patients with ages of 1 to 23 days, weight from 750 to 4,100 grams, and 63 observations made spanning a range of 85% to 99% SaO2.

1. Nellcor™ Sensors with OxiMax™ Technology Accuracy Grid. 2007. Available at: http://www.nellcor.com/_catalog/pdf/sns/prodman/10020661a00.pdf
2. FDA 510(k).