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SpO₂ Accuracy Clinical Consultancy

The mandatory industry standard YY 0784-2010 Medical electrical equipment – Medical pulse oximetry equipment for basic safety and essential performance requirement has been enforced since June 1, 2012.

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Q1: Why carry out clinical evaluation for SpO₂ accuracy? Can oximeter simulators be effectively used for SpO₂ accuracy evaluation?

A: As specified in ISO 9919:2005 FF.4, no simulator has been verified to be qualified for calibrating pulse oximeters.

The light and human tissue interaction principle of pulse oximetry is complex. Currently, relevant parties are developing fully validated POC equipment that can simulate partial optical characteristics, yet no successful development has been completed to date.

Therefore, the primary valid method to verify the SpO₂ accuracy of pulse oximeters is to compare the device readings against measurements from a CO‑oximeter. The CO‑oximeter conducts in-vitro optical measurement to calculate the concentrations of multiple hemoglobin variants in arterial blood. See also EE.2.

Q2: Med-Linket is not a clinical medical institution. Are your evaluation reports valid?

A: Med-Linket has invested 3 years to develop an oxygen concentration control (FiO₂) simulator and SaO₂ stability evaluation & data acquisition system.

We invested nearly RMB 1 million in precision testing instruments, and established cooperation with The First Affiliated Hospital of Sun Yat-sen University and Northern Guangdong People's Hospital to conduct clinical evaluation for invasive and non-invasive oximetry accuracy.

The two hospitals are official clinical institutions and can issue clinical evaluation reports in Chinese or English. These reports support product registration submissions to regulators including FDA, CE and NMPA (SFDA).

Q3: What advantages does Med-Linket have compared with laboratories in the United States?

Med-Linket supports advance trial testing, lowering the risk of failure in formal clinical evaluation.
For equivalent evaluation projects, our quotation is approximately half that of US laboratories. In addition, US laboratories charge consulting fees based on working hours.
Our project cycle is 3–4 months; shorter communication and equipment transit lead time can be achieved when cooperating with Med-Linket.
No cross-border customs clearance procedures for testing equipment are required.

Q4: What other services can Med-Linket provide?

Algorithm verification & accuracy verification at the R&D stage
Clinical evaluation consulting for non-invasive SpO₂ accuracy
Clinical evaluation consulting for invasive SpO₂ accuracy

SpO₂ Accuracy Clinical Consultancy

SpO₂ Accuracy Clinical Consultancy

Q1: Why carry out clinical evaluation for SpO₂ accuracy? Can oximeter simulators be effectively used for SpO₂ accuracy evaluation?

Q2: Med-Linket is not a clinical medical institution. Are your evaluation reports valid?

Q3: What advantages does Med-Linket have compared with laboratories in the United States?

Q4: What other services can Med-Linket provide?

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