Masking Between Reserved Alarm Sounds of the IEC 60601-1-8 International Medical Alarm Standard: A Systematic, Formal Analysis.

ABSTRACT

OBJECTIVE: In this work, we systematically evaluated the reserved alarm sounds of the IEC 60601-1-8 international medical alarm standard to determine when and how they can be totally and partially masked. BACKGROUND: IEC 60601-1-8 gives engineers instruction for creating human-perceivable auditory medical alarms. This includes reserved alarm sounds common types of alarms where each is a tonal melody. Even when this standard is honored, practitioners still fail to hear alarms, causing practitioner nonresponse and, thus, potential patient harm. Simultaneous masking, a condition where one or more alarms is imperceptible in the presence of other concurrently sounding alarms due to limitations of the human sensory system, is partially responsible for this. METHODS: In this research, we use automated proof techniques to determine if masking can occur in a modeled configuration of medical alarms. This allows us to determine when and how reserved alarm sound can mask other reserved alarms and to explore parameters to address discovered problems. RESULTS: We report the minimum number of other alarm sounds it takes to both totally and partially mask each of the high-, medium-, and low-priority alarm sounds from the standard. CONCLUSIONS: Significant masking problems were found for both the total and partial masking of high-, medium-, and low-priority reserved alarm sounds. APPLICATION We show that discovered problems can be mitigated by setting alarm volumes to standard values based on priority level and by randomizing the timing of alarm tones.