Testing of Auditory Clinical Alarms in ICU/CCU

S. Thangavelu, E. Supriyanto, J. Yunus
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Abstract

Almost all medical devices in ICU/CCU have a built-in clinical alarm system to alert when there are changes in a patient’s condition. The objective of this study is to investigate the effectiveness of the existing alarm system in ICU/CCU. Two summative usability tests were conducted to test the effectiveness of existing and new alarm signals based on IEC 60601-1-8:2006 standard. Further formative test was conducted to study perception of urgency associated with number of tones in the alarm signals. The findings indicate that the existing auditory alarm signal in ICU/CCU do not indicate the urgency of the alarm conditions. The simulation test indicates that the respondents preferred 282Hz, 500Hz and 800Hz for low, medium and high-risk alarm respectively. The one-sample proportion z test on urgency mapping indicates that the proportion of responses for highest risk is more than 50% for single tone test signal. These results show that single tone test signal being perceived as highest risk regardless of frequency. It can be concluded the auditory alarm designed based on this IEC 60608-1-8:2006 standard is not effective. As such it is proposed that incorporation of the new alarm frequencies and tones will improve the effectiveness of the alarm signal.
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ICU/CCU临床听觉报警的检验
几乎所有ICU/CCU的医疗设备都有内置的临床报警系统,当患者病情发生变化时发出警报。本研究的目的是探讨现有报警系统在ICU/CCU的有效性。根据IEC 60601-1-8:2006标准,对现有报警信号和新的报警信号进行了两项总结性可用性测试。进一步的形成性测试是为了研究与警报信号中音调数量相关的紧迫感感知。结果表明,ICU/CCU现有的听觉报警信号不能反映报警情况的紧迫性。仿真测试表明,受访者对低、中、高风险报警的首选频率分别为282Hz、500Hz和800Hz。紧急映射的单样本比例z检验表明,单音测试信号的最高风险响应比例大于50%。这些结果表明,无论频率如何,单音测试信号被认为是风险最高的。由此可见,根据IEC 60608-1-8:2006标准设计的声音报警器是无效的。因此,提出了新的报警频率和声音的合并将提高报警信号的有效性。
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