<p>Infant incubator is one of the most important medical devices for newborn survival, especially preterm. However, aside from its benefits, some irregularities can be found on the devices that could lead to infant mortality, such as temperature deviations. The problem can be minimized by testing the infant incubator temperature parameter in accordance with IEC 60601-2-19 standard. However, there are various types of temperature sensors for related tests. Therefore K-Type and T-Type Thermocouples are compared in order to provide recommendations for infant incubator testing. The measurement technique used were referred to the instructions stated in IEC 60601-2-19 sub-clause Stability (with tolerance ±0.5^oC) and sub-clause Uniformity (with tolerance ±0.8^oC). For K-type thermocouples, the highest stability results at 32^oC is -0.2^oC and at 36^oC is -0.4^oC, while the highest uniformity results at 32^oC is -0.1^oC and at 36^oC is -1.6^oC, with the uncertainty of 1.7^oC. For T-type thermocouples, the highest stability results at 32^oC is 0.4^oC and at 36^oC is -0.4^oC, while the highest uniformity results at 32^oC is 0.7^oC and at 36^oC is 0.8^oC, with the uncertainty of 0.3^oC. The results of the independent t-test showed a different average, where the T-type thermocouples was higher than the K-type thermocouples. In other words, T-type thermocouples could be recommended for infant incubators testing.</p>

ECG machines should be calibrated and tested to assure their accuracy. IEC 60601-2-25 standard described signals for calibrating ECG amplitudes and frequencies. The problem was this standard does not clearly describe the formulas of the calibration signals nor the complete database of these signals. The aim of this study was to get a database of ECG calibration signals for testing based on IEC 60601-2-25 standard clause 201.12.1.101. Data were constructed with a series of sinus function in Matlab software to simulate P, Q, R, S, and T segments. The data were visually and statistically compared with the data from commercial CTS database. Data were constructed for 3 different lead of 12 ECG calibration data. Four ECG calibration data with elevation or depletion ST segment were excluded from this study. This study demonstrated that these ECG calibration signals were slightly visually different and statically had differences in some of S wave and most of T wave. This data can be used by designers or manufactures, but for the testing laboratory is recommended using a commercial product.

The quality of medical devices is an important thing to establish the anamnesis, diagnosis and also treatment of patient. Arterial pressure measurement as one of the first indicators in the Hypertension Management Guidelines requires the accuracy as well as their function. Error in the detection of blood pressure should not occur during measurement because the errors will also make failure in determining the diagnosis and therapy for hypertensive patient, related on their hypertensive classification. Clinicians requires accurate medical measurement in order to monitor patients, diagnose diseases and deliver treatments. The failure of detection will certainly have diverse effects. Preliminary studies have shown that differences in results that are generated by two types of blood pressure devices, aneroid sphygmomanometers and digital blood pressure. The differences between both devices are 2-11, 6 mmHg for Systolic and 0.8 - 10.3 mmHg for diastolic. This differences led a new insight to the accuracy of blood pressure devices that are widely used in medical circles and the critical value of the accuracy of the sphygmomanometer can be the basis for determining clinical blood pressure classification. Therefore, it is necessary for medical staff to get information about the accuracy of blood pressure devices and its critical parameters in determining blood pressure, it is also necessary for a regulation on a blood pressure classification based on the type and level of accuracy of measuring instruments.

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