Subclause 6.12 – ALARM CONDITION logging

ü The logging of ALARM CONDITIONS can be useful for several reasons:

a) to determine the cause of a transient ALARM CONDITION when NON-LATCHING ALARM SIGNALS are used;

b) to determine the cause of an ALARM CONDITION when the equipment is unattended by an OPERATOR in NORMAL USE;

c) for quality assurance purposes;

d) for the study of critical incidents, similar to the event logging of aircraft "black-boxes";

e) to determine when an ALARM CONDITION occurred.

c) זהו כותרת ל-d).

כנראה שהכוונה ב-e) זוהי תוספת מידע ל-b).

ü LIFE-SUPPORTING EQUIPMENT or life-sustaining equipment as well as vital signs monitors should be equipped with ALARM CONDITION logging.

נכון, אז למה בסעיפים קודמים היתה הנחה שאולי אין לוג?

ü Means should be provided, either within the equipment or remotely through a communications interface, to store a history of ALARM CONDITIONS and their level of priority in an ALARM CONDITION log.

ü The log should also include the value of the variable that caused the ALARM CONDITION as well as the relevant current values of the elements in the ALARM PRESET including the ALARM LIMIT.

ü If there is a log, all generated ALARM SIGNALS of ALARM CONDITIONS, or all generated ALARM SIGNALS of ALARM CONDITIONS at or above a specified priority, should be logged.

למה יש כאן ספק אם יש לוג? הלא זוהי דרישה שיהיה לוג.

ü TECHNICAL ALARM CONDITIONS are as important as PHYSIOLOGICAL ALARM CONDITIONS, since many situations are problematic as to whether an ALARM CONDITION source is technical or physiological (e.g., low signal strength).

זה לא המקום להסביר מדוע צריך התרעה על תקלות טכניות

û In the ALARM OFF or ALARM PAUSED state, some equipment does not process signals (monitor for ALARM CONDITIONS) at all.

זה לא תקין, והתקן צריך לאסור זאת.

ü In these instances, ALARM CONDITIONS are not determined, and they cannot be logged.

ü Other equipment does process signals during ALARM OFF and/or ALARM PAUSED, and this equipment can log the ALARM CONDITIONS.

ü In every instance of AUDIO OFF or AUDIO PAUSED, however, ALARM CONDITIONS should be logged.

ü In any case, the entry and exit for each ALARM SIGNAL inactivation state (ALARM OFF, ALARM PAUSED, AUDIO OFF and AUDIO PAUSED) should be recorded.

ü An example will make this last situation clear. Suppose a monitor has a HIGH PRIORITY ALARM SIGNAL for high heart rate. ALARM CONDITIONS for high heart rate should be logged. If the OPERATOR places the high heart rate ALARM CONDITION in the ALARM OFF or AUDIO OFF state, that fact should be recorded in the log. In other words, the ALARM CONDITION log should reflect high heart rate ALARM CONDITIONS and any period of time in which the ALARM SIGNALS for high heart rate ALARM CONDITIONS were not generated or that auditory ALARM SIGNALS where not generated. Otherwise, the ALARM CONDITION log is meaningless, because review of the log would not reveal if:

f) there were no high heart rate ALARM CONDITIONS during that period, or

g) the ALARM SYSTEM was in an ALARM SIGNAL inactivation state during that period of time.

If the ALARM SYSTEM is provided with a log of ALARM CONDITIONS:

– the contents of the log can be stored either for a specified period of time or until deleted by RESPONSIBLE ORGANIZATION or OPERATOR action;

או נכון יותר עד לגיבוי בארכיון של הארגון

– the contents of the log should be available for review by the OPERATOR;

– short losses of power (less than 30 s) should not cause the loss of the contents of the log.

30 שניות זה הרבה זמן בטירונות. כאן רצוי להקצות יותר זמן להתגברות על תקלות.

ü The previously stored contents of the log can be deleted when the OPERATOR indicates to the equipment, preferably through an “admit new PATIENT" function, that a different PATIENT has been connected to the equipment.

ü MANUFACTURERS should consider including a log of TECHNICAL ALARM CONDITIONS that cannot be reset by OPERATOR action for servicing and maintenance purposes.

עדיף שיספק אמצעי גיבוי (CD) שיקליט את כל הפעילות במכשיר.