Accuracy Analysis of Oxygen Saturation Measurements of TKDN Oximeters Using the Uncertainty Method

This study aims to evaluate the accuracy and effectiveness of several domestic pulse oximeter brands (Elitech, Kaltech, and Endo) and a foreign brand (GE), calibrated using the Prosim SPOT Light SpO₂ Pulse Oximeter Tester. This quantitative study involved three domestically produced oximeters and one imported unit. The oxygen saturation setpoints were varied at 80%, 85%, 90%, 95%, 97%, 98%, 99%, and 100%, with three repetitions for each. Data analysis was conducted using the GUM Uncertainty Method and ANOVA statistical testing. The results show that all oximeters have combined uncertainty (expanded uncertainty, U₉₅) values between 0.58–3.23%, with reading deviations from reference values below ±2%, within acceptable tolerance limits. Kaltech and Endo oximeters demonstrated stable performance with no significant differences across saturation setpoints after calibration. Elitech and GE exhibited higher sensitivity to oxygen saturation variations, particularly at lower ranges. The One-Way ANOVA results indicated that Kaltech and Endo had p-values > 0.05, signifying no significant differences, while Elitech and GE showed p < 0.05, indicating differences between setpoints. Overall, domestically produced oximeters showed equivalent performance to imported devices after standard calibration, supporting the enhancement of Domestic Component Level (TKDN) and strengthening the independence of the national medical device industry.