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Product Test Report




Validation of the MYDOC SPO2 (MYDOC-113-003) Pulse Oximeter , in Photospectrometry method for self measurement in a general population





The Mydoc Spo2 (MYDOC-113-003) pulse Oximeter in photo spectrometry method, for self measurement in a general population. The device passed all of the requirement and fulfilling the standard of the protocol, is recommended for our personal use.



Device Details:
Brand MY DOC
Model MYDOC-113-003
Manufacture MYDOC
Location Finger Tip Pulse Oximeter
Method Photo spectrometry
Purpose Clinic measurement, Self/home measurement
Ideal For Adults
URL nriindex.com/mydoc
LOGO


Methodology:
Hemoglobin absorbs different wavelengths. Deoxygenated hemoglobin (Hb) Pulse oximetry is the non-invasive measurement of the oxygen saturation (SpO2). Oxygen saturation is defined as the measurement of the amount of oxygen dissolved in blood, based on the detection of Hemoglobin and Deoxyhemoglobin.Two different light wavelengths are used to measure the actual difference in the absorption spectra of HbO2 and Hb. The bloodstream is affected by the concentration of HbO2 and Hb, and their absorption coefficients are measured using two wavelengths 660 nm (red light spectra) and 940 nm (infrared light spectra). Deoxygenated and oxygenated has a higher absorption at 660 nm and oxygenated hemoglobin (HbO2) has a higher absorption at 940 nm. A photodetector in the sensor perceives the non-absorbed light from the LEDs. This signal is inverted using an inverting operational amplifier (OpAmp) and the result is a signal like the one in. This signal represents the light that has been absorbed by the finger and is divided in a DC component and an AC component. The DC component represents the light absorption of the tissue, venous blood, and non-pulsatile arterial blood. The AC component represents the pulsatile arterial blood.

Procedure:
1. Install and setup the Software and connect the usb cable to the device.
2. Place one of your finger (not thumb finger) into the rubber opening of pulse oximeter.
3. Press the switch button one time on the front panel to turn ON the pulse oximeter.
4. Keeping your hands till for the reading. Do not shake your finger during the test, it recommends that you do not move your finger.
5. Read the data from the display screen and remove from finger.

Result:
Subject Details:


Resolution 1 % SpO2 Oxygen Saturation, 1 bpm Pulse Rate
Pulse rate range 30 to 235 bpm
Measurement Accuracy Calibrated at 3 % SpO2 for Oxygen Saturation and 2 bpm for Pulse
Oxygen Saturation range 70 % SpO2 to99 % SpO2
Power supply 5v usb
Type Finger Tip Pulse Oximeter
Ideal For Adults
Operation temperature 5 ~ 40 'C
Storage Temperature -20 ~ +55'C


Normal condition reading:
SPO2:


No. Measured value Actual value Error %
1 96 97 1.04
2 98 98 0
3 97 98 1.09
4 96 97 1.04
5 99 100 1.01
6 98 97 -1.02
7 97 98 1.03
8 100 99 -1
9 97 98 1.03
10 98 98 0


Heart Rate:

No. Measured value Actual value Error %
1 82 80 -2.43
2 75 76 1.33
3 89 88 1.12
4 85 85 0
5 101 101 0
6 79 81 2.5
7 77 76 -1.29
8 81 80 -1.23
9 92 93 1.08
10 90 91 1.11


High Intensity light Testing:
Spo2:

No. Measured value Actual value Error %
1 97 98 1.03
2 96 98 2.08
3 100 100 0
4 97 98 1.03
5 97 98 1.03
6 97 98 1.03
7 99 100 1.01
8 96 98 2.08
9 94 96 2.12
10 96 97 1.04


Heart rate:

No. Measured value Actual value Error %
1 90 88 -2.22
2 98 96 -2.04
3 72 69 -4.16
4 74 71 -4.05
5 92 89 -3.26
6 100 99 -1
7 92 90 -2.17
8 98 97 -1.02
9 73 70 -4.11
10 82 78 -1.87


Variances:

- The testing on unhealthy patients is planned to do on device powered by Laptop and PC based user interface. But due to inconveniences for patients we need to use a USB based power band and instead of PC based user interface we used push button and blue tooth connectivity with a smart phone.

- For infants testing is done of leg finger instead of hand finger.

Discussion:
No specific problems were encountered during validation and disturbance conditions were fulfilled.

As the device has reached the required standards, it is recommended for personal use in a general population.

Conclusion:

As the device has reached the required standards, it is recommended for personal use in a general population.
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