Warranty; Clinical Studies - Covidien Nellcor FLEXMAX Instructions For Use Manual

Warranty

To obtain information about a warranty, if any, for this product, contact Covidien's Technical
Services Department, or your local Covidien representative (see back page).

Clinical Studies

Bland-Altman plots or SaO vs error (SpO - SaO ) are included to highlight the sampled data
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points that were collected as part of the clinical evidence used to support the performance
specifications (SpO accuracy) of this device.
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1) This information can be especially useful to clinicians.
2) SpO accuracy is validated by clinical tests, where the measured values of the sensors were compared with
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those of the arterial co-oximetry in healthy adult subjects over the specified functional oxygen saturation
range. These values were validated on the following monitors: Nellcor™ PM1000N, N-600x, N-560, N-395. A
functional tester may not be used to validate SpO accuracy.
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3) Pulse rate accuracy was verified by simulated bench tests to ensure entire range was verified. These values
were verified on the following monitors: Nellcor™ PM1000N, N-600x, N-560, N-395.
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