Testing Summary - Nonin Onyx II 9560 Instructions For Use Manual

Onyx II 9560 Care, Maintenance, and Cleaning
The advanced digital circuitry within the Model 9560 requires no calibration or periodic maintenance other than
battery replacement. Field repair of the Model 9560 circuitry is not possible. Do not attempt to open the Model 9560
case or repair the electronics. Opening the case will damage the Model 9560 and void the warranty. Do not open
the Model 9560 more than 90°, and do not twist or pull on the device when cleaning.
Cleaning the Onyx II Model 9560
CAUTIONS:
!
• Clean the device before applying it to a patient.
• Do not sterilize, autoclave, or immerse this device in liquid. Do not pour or spray any liquids into the device.
• Do not use caustic or abrasive cleaning agents, or any cleaning products containing ammonium chloride or
isopropyl alcohol.
1. Wipe the surfaces with a soft cloth dampened with a 10% bleach solution (household bleach [5.25% sodium
hypochlorite]). Do not use undiluted bleach or any cleaning solution other than those recommended here, as
permanent damage could result.
2. Dry with a soft cloth, or allow to air dry. Ensure that all surfaces are completely dry.

Testing Summary

SpO accuracy and low perfusion testing was conducted by Nonin Medical, Inc. as described below.
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SpO
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SpO accuracy testing is conducted during induced hypoxia studies on healthy, non-smoking, light-to-dark-skinned
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subjects in an independent research laboratory. The measured arterial hemoglobin saturation value (SpO
sensors is compared to arterial hemoglobin oxygen (SaO
co-oximeter. The accuracy of the sensors is in comparison to the co-oximeter samples measured over the SpO
range of 70-100%. Accuracy data is calculated using the root-mean-squared (A
ISO 80601-2-61 and ISO 9919, Standard Specification for Pulse Oximeters for Accuracy.
Low Perfusion Testing
This test uses an SpO
SpO levels. The module must maintain accuracy in accordance with ISO 80601-2-61 and ISO 9919 for pulse rate
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and SpO
Accuracy Testing
Simulator to provide a simulated pulse rate, with adjustable amplitude settings of various
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at the lowest obtainable pulse amplitude (0.3% modulation).
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) value, determined from blood samples with a laboratory
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value) for all subjects, per
rms
) of the
2
2
5