Onyx Vantage 9590 Care, Maintenance, And Cleaning; Equipment Response Time; Testing Summary; Spo 2 Accuracy 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. The device's expected service life is 5 years. 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 or equivalent.
(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.

Equipment Response Time

If the signal from the sensor is inadequate, the last measured SpO
freeze for 10 seconds and are then replaced with dashes.
SpO Values
2
Standard/Fast Averages SpO
Pulse Rate Values
Standard/Fast Averages Pulse Rate
Equipment Delays
Display Update Delay
Example: SpO
SpO decreases 0.75% per second; pulse rate = 75 BPM
2
The response of the 4-beat average is 1.5 seconds.

Testing Summary

SpO accuracy and low perfusion testing was conducted by Nonin Medical, Inc. as described below.
2
SpO Accuracy Testing
2
At an independent research laboratory, SpO
and female, non-smoking, light-to-dark-skinned subjects that are aged 18 years and older. The measured arterial hemoglobin
saturation value (SpO
samples with a laboratory co-oximeter. The accuracy of the device is in comparison to the co-oximeter samples measured
over the SpO
ISO 80601-2-61 and ISO 9919, Standard Specification for Pulse Oximeters for Accuracy.
Low Perfusion Testing
This test uses an SpO
The device must maintain accuracy in accordance with ISO 80601-2-61 and ISO 9919 for pulse rate and SpO
obtainable pulse amplitude (0.3% modulation).
Performance in Motion
Motion artifact simulation introduced by a pulse oximeter tester determines whether the oximeter meets the criteria of
ISO 80601-2-61 and ISO 9919 for pulse rate during simulated movement, tremor, and spike motions.
Contact regulatory@nonin.com for more information regarding motion testing.

Principles of Operation

Pulse oximetry is a non-invasive method that passes red and infrared light through perfused tissue and detects the fluctuating
signals caused by arterial pulses. Well-oxygenated blood is bright red, while poorly oxygenated blood is dark red. The pulse
oximeter determines functional oxygen saturation of arterial hemoglobin (SpO
ratio of absorbed red and infrared light as volume fluctuates with each pulse.
2
Exponential Averaging
2
) of the device is compared to arterial hemoglobin oxygen (SaO
2
range of 70–100%. Accuracy data is calculated using the root-mean-squared (A
2
Simulator to provide a simulated pulse rate, with adjustable amplitude settings of various SpO
2
and pulse rate values
2
Average Latency
4 beat exponential 2 beats
Response Latency
4 beat exponential 2 beats
Delay
1.5 seconds
accuracy testing is conducted during induced hypoxia studies on healthy, male
2
) value, determined from blood
2
value) for all subjects, per
rms
) from this color difference by measuring the
2
levels.
2
at the lowest
2
4