Subclause 6.11.2.2 – Failure of remote communication of ALARM CONDITIONS

ü A DISTRIBUTED ALARM SYSTEM might not receive a message from the ALARM SYSTEM indicating an ALARM CONDITION that was detected by the ALARM SYSTEM.

בגלל תקלה, או שיש גם מצבים אחרים שההודעה אינה עוברת?

ü If an OPERATOR is depending on the remote generation of ALARM SIGNALS for treatment decisions, then it is necessary for the ALARM SYSTEM to know when an ALARM CONDITION has been successfully received by the DISTRIBUTED ALARM SYSTEM.

ü When those ALARM CONDITIONS are not successfully received, generating ALARM SIGNALS to indicate a TECHNICAL ALARM CONDITION to warn the OPERATOR of such a fault, is necessary for safety when an ALARM SYSTEM includes a DISTRIBUTED ALARM SYSTEM.

ü With some technologies, it can be impossible for a primary ALARM SYSTEM to know if a DISTRIBUTED ALARM SYSTEM has not received an ALARM CONDITION, or if it has failed.

M In this case, the MANUFACTURER is required to warn the RESPONSIBLE ORGANIZATION and the OPERATOR by marking the equipment not to rely upon the DISTRIBUTED ALARM SYSTEM for generation of ALARM SIGNALS. A DISTRIBUTED ALARM SYSTEM can be useful, even if it does not work 100 % of the time. Still, MANUFACTURERS and RESPONSIBLE ORGANIZATIONS should take precautions that PATIENT safety is not compromised.

בבית המשפט, אחראי המשמרת יגיד שהתקן מרשה שלא כל ההתרעות תשמעה.