Reference to 60601-1-8
Perhaps the main contribution of the international standard 60601-1-8 is in setting a unique set of terms. The standard solves a severe problem of term ambiguity, in which the same term was used for different meanings, and different terms had the same meaning. It is therefore highly desirable that the alarm system uses the terms as in the section 3: term and definition section of IEC 60601-1-8, because this is the language that enables unambiguous communication with the manufacturer.
Practically, we recommend to the customers who intend to purchase the alarm system that they verify with the manufacturer that the terms they use are according to the standard.
It should be noted that IEC 60601-1-8 adapted terms of technical flavor, such as "false-negative alarm condition", used in the theory of signal detection.
This guide uses mainly operational terms to describe the user activities. To enable communication with the manufacturers, it occasionally refers to terms used in the standard.
|Configuration mode||Either Local or Remote||Distributed alarm system|
|Operation mode||Either Normal or Training||-|
|Patient mode||Either Assigned or Released||Alarm Off (and On)|
|Alarm mode||Either Visual (muted) or Audio-visual||Audio Off (and On)|
|Measured risk||The percentage of the population having a sensor value more extreme that the measurement||-|
|Patient risk||The highest risk measured from all sensors||-|
|Patient safety||100% - Patient-risk (the opposite of patient risk).||-|