RESUMO
OBJECTIVES: This paper suggests the experimental guidelines to evaluate the electro-mechanical safety of belt type equipment. The electro-mechanical safety was determined by using the International Electrotechnical Commission guidelines, which are widely used as important factors for assessing the electro-mechanical safety of belt type equipment. However, the local guidelines on wearable healthcare sensors are currently not well-established. Therefore, safety guidelines suited for the actual circumstances in Korea are required, and this paper attempts to try a new experimental safety test procedure of the wearable healthcare sensor. METHODS: This belt type device measures the electrocardiogram (ECG) and heart rates by attaching to the chest. Examination lists were selected by analyzing the common standards ofelectro-mechanical safety (IEC 60601-1) and environment tests (IEC 60068-1, IEC 60068-2) of home-healthcare equipment. RESULTS: The essential electrical safety, which was required for the RS300G3 as a medical device, was evaluated, and most of the examination lists were selected by considering the circumstances of the users. The device passed all the selected examinable lists that are applicable to the Korean environment. CONCLUSIONS: This study has limitations to estimate and to conduct electro-mechanical safety experiments because our study focused on the belt type of heart-rates equipment. We are not taking into account the overall electro-mechanical home-healthcare measurements. According to industrial and technological development, there are infinite possibilities for the advancement of home-healthcare equipment, so more examination lists for safety are being added in addition to what we have done.
RESUMO
Heart rate variability (HRV) is a noninvasive measure of autonomic input to heart rate that has been successfully used to estimate modulation of autonomic tone. The authors investigated to determine the normal ranges as a standardized tests of heart rate variability (HRV) for autonomic function tests in a large sample of healthy Koreans. The study also evaluated the effects of age, sex, and heart rate (HR) on the results of HRV and the values of HRV in hypertension, diabetes, and obesity group. Six hundred and thirty-seven healthy subjects who visited the health improvement center for medical examination were evaluated. A standardized 5-min resting study, including spectral analysis of HR, was used to all participants after an overnight fast. HRV (SA-2000E, Medicore, Korea) was spectrally determined by three components: total-frequency (TF) component (0.01 to 0.5 Hz), low-frequency (LF) component (0.04 to 0.15 Hz), and high-frequency (HF) component (0.15 to 0.5 Hz). Also two component ratio (LF/HF) was calculated. Routine laboratory and physical examinations were used to eliminate cardiovascular diseases and neurological disorders. The determinants of short-period HRV in a random sample of 366 men and 271 women from healthy subjects were assessed. The mean age of these subjects was 45.1 +/- 10.7 years. The mean value of total power was 1106.9 +/- 1109.1 ms(2); SDNN was 35.9 +/- 15.5 ms; rMSSD was 27.3 +/- 15.6 ms for time domain analysis. The mean value of LF was 287.5 +/- 384.1 ms(2); HF was 227.0 +/- 284.4 ms(2); LF/HF was 2.2 +/- 3.4 for frequency domain analysis. Additionally, men showed that their TP, LF, and LF/HF values were significantly higher than women whereas SDNN, rMSSD, HF showed no significant differences between sexes. With increasing age, there was no significant decrease in HR. TP, SDNN, LF, and HF were significantly decreased when getting older. On the contrary, LF/HF had no significant difference related to age. The study confirmed that SDNN and rMSSD were significantly lower in hypertension and diabetes group. In conclusion, middle-aged men had more pronounced sympathetic influence than women in cardiac regulation, and HRV declined linearly with age. In addition, HRV reflecting the function of autonomic nervous system was decreased in hypertension and diabetes group.
