הכותרת
של סעיף זה
אינה מרמזת על
תוכנו. התוכן של
סעיף זה הוא
תהליך
האיתחול, ולא
ברירת המחדל,
שהיא פרט
במכלול
השיקולים.
6.5.4.1 General requirements
If the DEFAULT ALARM PRESET can be set to values that differ from the
MANUFACTURER
configured values:
a) means shall be
provided to prevent any OPERATOR from storing changes to the DEFAULT ALARM PRESET. Storing changes to the DEFAULT ALARM
PRESET shall be
restricted to the RESPONSIBLE ORGANIZATION (see 6.7);
and
b) means shall be
provided to the RESPONSIBLE ORGANIZATION to restore the DEFAULT ALARM PRESET to its MANUFACTURER-configured values.
Compliance is checked by inspection.
6.5.4.2 * Selection of DEFAULT
ALARM PRESET - Rational
Whenever:
כאן מדובר
על מתי עושים
את האתחול
a) the OPERATOR switches the ALARM SYSTEM on after an interval specified by the MANUFACTURER as being longer than might be considered
unintentional; or
b) the ALARM SYSTEM is enabled; or
c) the OPERATOR indicates to the ALARM SYSTEM, preferably through an “admit new PATIENT” function, that a different PATIENT has been connected to the ALARM SYSTEM; or
d) power is restored to the ALARM SYSTEM after it has experienced a total loss of
power (SUPPLY MAINS and/or INTERNAL ELECTRICAL POWER SOURCE) beyond the time that it automatically
restores the ALARM SETTINGS (see 6.5.5);
then:
כאן מדובר
מה האתחול
כולל
e) the DEFAULT ALARM
PRESET shall be
automatically selected; or
f) means shall be
provided for the OPERATOR to select an ALARM PRESET; or
g) means may be
provided for the OPERATOR to select the retained ALARM SETTINGS from the previous use.
û
The MANUFACTURER shall disclose in the instructions for
use an estimate of the duration of the power interruption after which the ALARM SYSTEM is unable to restore the ALARM SETTINGS and the subsequent behaviour
of the ALARM SYSTEM.
במקום זה
– היצרן צריך
לספק מנגנון
לשחזור ערכי
האיתחול ברמת היצרן
וברמת הארגון.
במכשירים בהם
נדרש שחזור
ערכים שהציב
המשתמש (אם יש
כאלו), היצרן
צריך לספק
מנגנון
להתרעה על כך
שבטריית
הגיבוי עומדת
להגמר.
ü
Compliance
is checked by observing the equipment’s ALARM SETTINGS, then temporarily disconnecting the power
source for a period exceeding that indicated in the instructions for use and
then inspecting the state of the ALARM
SETTINGS. The mains switch, if provided, shall remain in
the ‘on’ position during this test. Inspect the ALARM SETTINGS and compare them to the
appropriate behaviour.
מעניין למה
רק בסעיף זה
התקן מפרט את
תהליך הבדיקה.
אפשר, ואולי
צריך לעשות
זאת בסעיפים
רבים אחרים בתקן.