Subclause 6.11 – DISTRIBUTED ALARM SYSTEM

The application of DISTRIBUTED ALARM SYSTEMS is in its infancy. New ideas and new technology are bringing rapid advances and changes in this area. Long-, medium- and shortrange two-way wireless communication opens new opportunities and new challenges for DISTRIBUTED ALARM SYSTEMS. At the same time, OPERATORS with different clinical training and new roles for OPERATORS will change the way that OPERATORS respond to ALARM SIGNALS. In many instances, remote OPERATORS can be at a distance from the PATIENT such that they cannot personally respond to a PATIENT or equipment problem.

The committee believed that the field was too immature to write a large number of specific requirements. Perhaps a future edition of this collateral standard will be able to include more specific requirements, when the technology has matured. In the meantime, a MANUFACTURER is left to use good RISK ANALYSIS to be sure that their DISTRIBUTED ALARM SYSTEMS serve their primary purpose: to improve the ability of a qualified OPERATOR to respond in an appropriate and timely manner to every ALARM CONDITION.

הוועדה מתחמקת מהתעסקות בשימושיות, (כנראה מפני שלחברי הוועדה אין נסיון בנושא מערכות מבוזרות), בתירוץ של חוסר בשלות טכנולוגית. הטכנולוגיה רלבנטית רק לבעיות מסדר שני.

Future systems can include transmission of ALARM SIGNALS via wired or wireless local area networks, wired or wireless devices connected to the Internet, commercial landline and cellular telephone networks, commercial one-way or two-way paging systems, and other systems. In all these systems, there can be delays in ALARM CONDITION transmission because of demands on networks and other systems. In every case there will be a delay before the ALARM SYSTEM detects an ALARM CONDITION, a delay before generation of ALARM SIGNALS at the primary ALARM SYSTEM, a delay before the ALARM CONDITION is transmitted to a DISTRIBUTED ALARM SYSTEM, and a delay before the DISTRIBUTED ALARM SYSTEM generates ALARM SIGNALS. Since these delays can vary at times due to factors outside the control of the MANUFACTURER and many of these delays are not deterministic, a statistical analysis will be required to determine the time before the ALARM CONDITION is indicated with ALARM SIGNALS to the appropriate OPERATOR. It may not be possible to guarantee a maximum time.

ניתן לדרוש שההשהיות יהיו במכסימום בערך מסוים, שמתאים לחלק מסוים של הזמן הקריטי. למשל, כל ההתרעות יופעלו תוך 10% מהזמן הקריטי.

ü         Any system of transmission of information is subject to failure.

C’est la vie

ü         In the event of failure of a DISTRIBUTED ALARM SYSTEM or of the link between a primary ALARM SYSTEM and a DISTRIBUTED ALARM SYSTEM, the primary ALARM SYSTEM is required to generate ALARM SIGNALS normally.

לא מצאתי הגדרה של ה-Primary ALARM SYSTEM . אני מניח הכוונה היא למדיד שמדד את המצב המחייב התרעה.

 

ü         If the primary ALARM SYSTEM had been placed in the state of AUDIO PAUSED, AUDIO OFF, ALARM PAUSED, or ALARM OFF and the system had been relying on a DISTRIBUTED ALARM SYSTEM for attention to ALARM CONDITIONS (e.g. the DISTRIBUTED ALARM SYSTEM is not inactivated), then if the DISTRIBUTED ALARM SYSTEM fails, the primary ALARM SYSTEM should be automatically reenabled.

במלים פשוטות – איתחול אוטומטי של ההתרעות במקרה של תקלת תקשורת עם המרכזיה

ü          EXAMPLE The local ALARM SYSTEM is AUDIO OFF (auditory ALARM SIGNAL volume set to zero) while the DISTRIBUTED ALARM SYSTEM is relied on to notify the OPERATOR. Upon detection of the failure, the local ALARM SYSTEM should return the volume to an audible level.

ü         In addition, the primary ALARM SYSTEM and the DISTRIBUTED ALARM SYSTEM should both generate ALARM SIGNALS to alert the OPERATOR(S) to failure of the DISTRIBUTED ALARM SYSTEM.

ü         Some members of the committee argued that ALARM SIGNALS should always be delivered to the appropriate OPERATOR under SINGLE-FAULT CONDITION, at least for LIFE-SUPPORTING EQUIPMENT.

û       The committee felt it to be impossible to specify requirements and tests for every such situation in this collateral standard.

לדעתי, צריך לפתור את הבעיה בניתוח מערכת. אולי היו יותר מדי אנשים בוועדה

In any event, as noted above, RISK ANALYSIS should be done in this area. Furthermore, MANUFACTURERS are required to disclose the characteristics, limitations and possible failure modes of their DISTRIBUTED ALARM SYSTEMS.