Onyx Vantage 9590 Care, Maintenance, And Cleaning; Testing Summary; Spo 2 Accuracy Testing During Motion And Non-Motion; Low Perfusion Testing - Nonin Onyx Vantage 9590 Instructions For Use Manual

Onyx Vantage 9590 Care, Maintenance, and Cleaning

The advanced digital circuitry within the device requires no calibration or periodic maintenance other than battery
replacement. Field repair of the 9590 circuitry is not possible. Do not attempt to open the case or repair the electronics.
Opening the case will damage the device and void the warranty. Do not open the 9590 more than 90°, and do not twist or
pull on the device when cleaning.
Cleaning the Onyx Vantage 9590
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 onto the device.
• Do not use caustic or abrasive cleaning agents, or any cleaning agent containing ammonium chloride or isopropyl
alcohol.
1. To clean, wipe the surfaces with a soft cloth dampened with mild detergent or 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, motion, and low perfusion testing was conducted by Nonin Medical, Inc. as described below.
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SpO Accuracy Testing During Motion and Non-motion
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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
is compared to arterial hemoglobin oxygen (SaO
The accuracy of the device is in comparison to the co-oximeter samples measured over the SpO
Accuracy data is calculated using the root-mean-squared (A
Specification for Pulse Oximeters for Accuracy.
Pulse Rate Motion Testing
This test measures pulse rate oximeter accuracy with motion artifact simulation introduced by a pulse oximeter tester. This
test determines whether the oximeter meets the criteria of ISO 9919 for pulse rate during simulated movement, tremor,
and spike motions.

Low Perfusion Testing

This test uses an SpO
levels. The device must maintain accuracy in accordance with ISO 9919 for pulse rate and SpO
pulse amplitude (0.3% modulation).
) value, determined from blood samples with a laboratory co-oximeter.
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Simulator to provide a simulated pulse rate, with adjustable amplitude settings of various SpO
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value) for all subjects, per ISO 9919, Standard
rms
) of the device
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range of 70-100%.
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at the lowest obtainable
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