Subclause 6.6.2 – Adjustable ALARM LIMIT

ü Care should be used in the design of an ALARM SYSTEM if an OPERATOR is permitted to set an ALARM LIMIT to extreme values.

ü Such action by the OPERATOR can have the effect of defeating both the auditory and visual ALARM SIGNALS, without providing a visual indication that the ALARM CONDITION is effectively disabled (see the second paragraph of 5.2.1).

ü Care also needs to be taken that any absolute lower and upper ALARM LIMITS will not be reached by PATIENTS in clinical practice, as this would cause a situation in which an ALARM CONDITION is continuously and erroneously indicated by ALARM SIGNALS.

ü The provision and use of a pre-use checklist to verify ALARM LIMIT(S) is encouraged.

אפשר אולי לכלול דוגמא בתקן, ואפשר לדרוש מהיצרן לספק הנחיות לבדיקה.