Anesth Pain Med.  2020 Jul;15(3):371-377. 10.17085/apm.20028.

Performance of the MP570T pulse oximeter in volunteers participating in the controlled desaturation study: a comparison of seven probes

• Choi BM
• Kang BJ
• Yun HY
• Jeon B
• Bang JY
• Noh GJ

• KMID: 2504901
• DOI: http://doi.org/10.17085/apm.20028

Abstract

Background
The performance of the pulse oximeter was evaluated based on the ISO 80601-2-61:2011 (E) guidelines. This study aimed to determine whether the various finger probes of the MP570T pulse oximeter (MEK-ICS Co., Ltd., Korea) would provide clinically reliable peripheral oxygen saturation (SpO2) readings over a range of 70100% arterial oxygen saturation (SaO2) during non-motion conditions.
Methods
Each volunteer (n = 12) was connected to a breathing circuit for the administration of a hypoxic gas mixture. For frequent blood sampling, an arterial cannula was placed in a radial artery. The following seven pulse oximeter probes were simultaneously attached to each volunteer’s fingers: (1) WA-100 reusable finger probe (MEDNIS Co., Ltd., Korea), (2) MDNA disposable finger probe (MEDNIS Co., Ltd.), (3) IS-1011 disposable finger probe (Insung Medical Co., Ltd., Korea), (4) CJ340NA disposable finger probe (CHUN JI IN Medical Co., Ltd., Korea), (5) NellcorTM OxiMax DS-100A reusable finger probe (Medtronic, USA), (6) NellcorTM OxiMax MAX-N disposable finger probe (Medtronic), and (7) OXI-PRO DA disposable finger probe (Bio-Protech Inc., Korea).
Results
A total of 275 SpO2-SaO2 pairs were included in the analysis. The accuracy of the root mean square (Arms) of each probe was 2.83%, 3.98%, 3.75%, 6.84%, 3.43%, 5.17%, and 3.84%, respectively.
Conclusions
The MP570T pulse oximeter with WA-100 reusable, MDNA disposable, IS-1011 disposable, NellcorTM OxiMax DS-100A reusable, and OXI-PRO DA disposable finger probes meets an acceptable standard of SpO2 accuracy under non-motion conditions.

Keyword

Hypoxia; Medical device; Performance; Pulse oximetry

Figure

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  Fig. 1. Target plateaus of oxygen saturation and sampling points. The red dots represent the SaO2 value at each sampling point. According to the SaO2 stability standard of the pulse oximeter probe placement site, the first sample at each plateau was acquired 30 s after reaching a target plateau, and the successive sample was acquired at least 20 s after the first sample.

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  Fig. 2. Measured SpO2 (SpO2i) versus reference SaO2 (SRi) plots. (A) WA-100 reusable finger probe, (B) CJ340NA disposable finger probe. The linear regression line (red solid line) and the equation with R2 are shown on the plot. The line of identity (blue dotted line) represents when SpO2i = SRi. SpO2: pulse oxygen saturation, SaO2: oxygen saturation of arterial blood, SpO2i: SpO2 measured by the device being tested, SRi: SaO2 measured by the reference CO-oximeter.

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  Fig. 3. Bland-Altman plots, with mean bias and 95% limits of agreement. (A) WA-100 reusable finger probe, (B) CJ340NA disposable finger probe. Mean error and y = 0 are shown as red solid and black dashed lines, respectively. The upper limit (mean bias + 1.96 × SD) and lower limit (mean bias 1.96 × SD) of the agreement are shown as a gold dotted line. SpO2i: peripheral oxygen saturation measured by the device being tested, SRi: oxygen saturation of arterial blood measured by the reference CO-oximeter.

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  Fig. 4. Bias (SpO2i - SRi) versus reference SaO2 (SRi) plots, with mean bias and 95% limits of agreement. (A) WA-100 reusable finger probe, (B) CJ340NA disposable finger probe. Mean error and y = 0 are shown as red solid and black dashed lines, respectively. The upper limit (mean bias + 1.96 × SD) and lower limit (mean bias 1.96 × SD) of the agreement are shown as a gold dotted line. SpO2i: peripheral oxygen saturation measured by the device being tested, SRi: oxygen saturation of arterial blood measured by the reference CO-oximeter.

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