6.3.3.1 * Characteristics of auditory ALARM SIGNALS - Rational

ü An ALARM SYSTEM provided with auditory ALARM SIGNALS shall have at least one set of ALARM SIGNALS that either:

a) is priority encoded and meets the requirements of Table 3 and Table 4; (Rational), or

b) is generated by means of different technology (e.g., voice synthesizing of verbal ALARM SIGNALS) and is VALIDATED (e.g., by clinical or simulated clinical USABILITY testing) (Rational).

ü If the ALARM SYSTEM is additionally provided with other sets of auditory ALARM SIGNALS, the following shall apply (Rational):

c) auditory ALARM SIGNALS shall be priority encoded;

d) HIGH PRIORITY auditory ALARM SIGNALS of a particular set of ALARM SIGNALS shall convey a higher level of urgency than the MEDIUM or LOW PRIORITY ALARM SIGNALS and INFORMATION SIGNALS of that ALARM SIGNAL set;

e) MEDIUM PRIORITY auditory ALARM SIGNALS of a particular set of ALARM SIGNALS shall convey a higher level of urgency than the LOW PRIORITY ALARM SIGNALS and INFORMATION SIGNALS of that ALARM SIGNAL set;

f) auditory ALARM SIGNALS shall be VALIDATED, e.g., by clinical or simulated clinical USABILITY testing;

g) means shall be provided to store a set of auditory ALARM SIGNALS in the DEFAULT ALARM PRESET (Rational); and

h) means may be provided to store a set of auditory ALARM SIGNALS in any ALARM PRESET (Rational).

ü NOTE 1 See also Annex D.

ü NOTE 2 Attention is drawn to IEC 60601-1-6.

ü Any melody shall preclude the possibility of confusion with the auditory ALARM SIGNALS of Table 3, Table 4 and Annex F, unless their meaning is the same.

? If any of the melodies of Annex F is used to meet the requirements of Table 3, Table 4, its meanings shall be as specified in Annex F.

בעיית ניסוח, או אי הבנה שלי?

In case of failure

ü When a TECHNICAL ALARM CONDITION that precludes the generation of the usual ALARM SIGNALS occurs, e.g. power or ALARM SYSTEM failure, the ALARM SYSTEM may generate an auditory ALARM SIGNAL that does not comply with the above requirements.

ü If selection of auditory ALARM SIGNAL sets is provided, means shall be provided for the RESPONSIBLE ORGANIZATION to prevent the OPERATOR from unauthorized access to changing the auditory ALARM SIGNAL set in use (see 6.7).

היצרן צריך לספק מנגנון הגנה, למשל, על ידי סיסמא

ü Compliance is checked by inspection and functional testing of the ALARM SYSTEM and inspection of any relevant VALIDATION documentation.

אפשר לדרוש מהארגון לחזור על בדיקות השימושיות של היצרן. היצרן יכול לספק ללקוח סט של תרחישים ותוכנת הדמיה, על מנת שילמד להכיר את ההתרעות מראש.