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Traditional 510(k) of Fetal & Maternal Monitor
F15 Series Fetal & Maternal Monitor User Manual
NOTE:
You can select Main Menu > Alarm > Review Alarms to set up On (by default) or OFF. When the
alarm review is enabled, the icon will appear on the main interface.
4.15 Alarm Treatment Measures
During monitoring, make sure there is at least one physician in the area where the alarm sound can be
heard or the alarm messages can be seen, so necessary measures can be taken when an emergency
occurs.
When the monitor gives out an alarm and catches your attention, you should:
- Check the patient's condition.
- Identify the cause of the alarm.
- Silence the alarm if necessary.
- Check if the alarm is terminated when the alarm condition is solved.
When the monitored parameter(s) come(s) back within the adjusted limits, or if the abnormal technical
condition does not exist any longer, the monitor stops giving out the alarm.
If "Transducer Unplugged" is enabled (set to "ON"), and you press the probe off key
main interface to confirm any active transducer unplugged alarm: US1 UNPLUGGED, US2
UNPLUGGED, US3 UNPLUGGED, TOCO UNPLUGGED, DECG UNPLUGGED, SpO2 SENSOR
OFF, TEMP UNPLUGGED, US1 Signal Weak, US2 Signal Weak, US3 Signal Weak, DECG Signal
Weak, DECG LEADS OFF, IUP LEADS OFF, ECG LEADS OFF and ECG Signal Weak,
FHR1/FHR2/FHR3 Low Variability, FHR1/FHR2/FHR3 Delayed Deceleration, FHR1/FHR2/FHR3
Sinusoidal Mode, FHR1/FHR2/FHR3 Tachycardia Without Variability, FHR1/FHR2/FHR3 Suspected
Delay Deceleration during the monitoring process, the transducer unplugged alarm(s) will be turned
off audibly and visually until any of them occurs again. But the transducer unplugged alarm(s) still
exist(s) in the alarm review list.
4.16 Testing Alarms
To test the functions of visible and audible alarms, do the following:
1
Switch on the monitor.
2
Enable the alarm.
3
Set the alarm limits to a small range.
4
Stimulate a signal that is higher than the upper limit or lower than the lower limit. Or
disconnect one of the plugs.
5
Verify if the visible and audible alarms are working properly.
4.17 Patient Alarm Defaults
Alarm Setting
High Priority
ASYSTOLE
Asystole Alarm Delay
Asystole Alarm Priority
Medium Priority
FHR1/DFHR/FHR2/FHR3
Alarm
014_14.1_F15_Series_User_Manual
Options
On (not adjustable)
0 seconds (not adjustable)
High (not adjustable)
On, Off
- 55 -
Alarms
on the
Default
On
0 seconds
High
On
71／202
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