ü
If deemed acceptable by RISK ASSESSMENT with regard to the intended environment
of use of the ALARM SYSTEM, a global ALARM OFF or AUDIO OFF may be provided. If an ALARM SYSTEM is provided with a global ALARM OFF or AUDIO OFF, the ALARM SYSTEM shall be provided with:
a) a REMINDER SIGNAL; and
b) means to configure (enable or disable)
any global ALARM OFF or
AUDIO
OFF. Such means shall
be restricted to the RESPONSIBLE ORGANIZATION and shall prevent the clinical OPERATOR from changing the configuration in NORMAL USE (see 6.7).
וגם את
מרווח הזמנים
עד לתזכורת
NOTE 1 A global ALARM OFF or AUDIO OFF ALARM
SIGNAL inactivation state affects all PHYSIOLOGICAL ALARM
CONDITIONS in an ALARM SYSTEM with multiple PHYSIOLOGICAL
ALARM CONDITIONS.
זה צריך
להיות בפרק
ההגדרות
NOTE 2 See also 6.8.2 for
requirements for REMINDER SIGNALS.
û
Compliance
is checked by inspection.
בדיקות פונקציונליות
ובדיקות
שימושיות