Subclause 6.5.4.2 – Selection of DEFAULT ALARM PRESET

The start-up sequence of an ALARM SYSTEM needs careful design to prevent nuisance ALARM SIGNALS. In older ME EQUIPMENT, when it was switched on, any ALARM LIMIT in violation immediately caused an ALARM SIGNAL, even though no PATIENT was connected to the ME EQUIPMENT! Later ME EQUIPMENT, when it was switched on, entered a state of ALARM OFF, or AUDIO OFF, and the state had to be deliberately terminated by OPERATOR action. Additional safety was provided with the introduction of ME EQUIPMENT with automatic enabling of the ALARM SYSTEM when a PATIENT was connected to the ME EQUIPMENT, or when a valid physiologic signal was first present (for instance, five normal breaths or five heartbeats within a certain time interval), or through an “admit new PATIENT” function which was activated by the OPERATOR.

Another situation is the desire to set up the ME EQUIPMENT, including the ALARM SYSTEM, before the PATIENT is connected. In this instance, it is desirable for the OPERATOR to select the ALARM PRESET, and perhaps to modify values from the ALARM PRESET for the PATIENT planned, without enabling the ALARM SYSTEM. The ALARM SYSTEM would then be enabled, either manually or preferably automatically, when the PATIENT is later connected to the ME EQUIPMENT.

A final situation is when the ALARM SYSTEM, or part of the ALARM SYSTEM, is in separate equipment. For instance, a gas delivery system might incorporate a separate gas monitor with its own ALARM SYSTEM, or an electronic record keeper or another equipment might combine the signals from several items of ME EQUIPMENT into a single ALARM SYSTEM. In this instance the primary ME EQUIPMENT and its ALARM SYSTEM might be switched on separately. Another example is a DISTRIBUTED ALARM SYSTEM of a PATIENT monitor with a central station. The ALARM SYSTEM of a central station should not be enabled when no PATIENT is connected! As in the earlier example, it would not be desirable to have the ALARM SYSTEM enabled until the ME EQUIPMENT is in actual clinical use.

לפי מיטב ידיעתי, המונח ערך ברירת מחדל וערך איתחול הם מקבילים. נראה לי שכאן האבחנה נעשית בשלשה תחומים: א. מי רשאי לשנות את הערכים, ב. כיצד נעשה תהליך האיתחול ו-ג. על אילו נתונים מסתכלים: פרמטרים של החולה או פרמטרים של ההתרעה הקולית. לדעתי, התקן לא מגדיר טוב את המונחים הללו.

When choosing the DEFAULT ALARM PRESET, a RESPONSIBLE ORGANIZATION should check that other devices in the PATIENT care area (e.g., pagers, mobile phones) do not generate sounds that could be confused with the auditory ALARM SIGNALS that are being chosen, unless their meaning is the same.