EDAN F15 Series User Manual page 81

Traditional 510(k) of Fetal & Maternal Monitor
F15 Series Fetal & Maternal Monitor User Manual
FT20 MALF
Current network
environment
poor(FT20)
FT20 Wireless
Signal Weak
ECG LEADS OFF
ECG SINGNAL
EXCEEDS LIMIT
Bad contact
between the
electrode sleeve
and the skin
ECG Signal Weak
HR EXCEEDS
MEASUREMENT
RANGE
NIBP EQUIP
MALF
NIBP SYSTEM
FAILURE
NIBP Airway
Pressure
Abnormality
NIBP CUFF
LOOSE or OFF
NIBP OVER
PRESSURE
014_14.1_F15_Series_User_Manual
FT20 is disconnected with the
monitor
The current network environment
is poor and FT20 module has
problem to connect with the
monitor
The wireless signal of FT20
module is too weak for the system
to analyze.
The ECG cable is not well
connected to the transducer, or
the leads of the ECG cable are not
well attached to the patient.
ECG signal exceeds
measurement limits.
Bad contact between
electrode sleeve
transducer and the skin.
The ECG signal is too weak that
the system can't calculate HR
correctly.
The heart rate exceeds
measurement limits.
The NIBP board
communicate with the system
successfully.
The NIBP module defective.
NIBP cannot be deflated, and the
system pressure has remained
unchanged
The cuff is loose or not connected. Wrap the cuff properly.
The pressure has exceeded the
specified upper safety limit.
Restart the monitor and try again, contact
the manufacturer if the connection still
fails.
Check whether the ambulating mother
has reached the limit of the active signal
area-of-reach and whether the network
communication is fine.
Check whether the ambulating mother
has reached the limit of the active signal
area-of-reach and whether the network
communication is fine.
Check the connection between the ECG
cable and the monitor or the TOCO-E
transducer. Check also the attachment of
the ECG leads to the patient.
the Check the connection of the leads and the
patient's condition.
the Adjust the transducer and make sure
of TOCO good contact between the electrodes and
the skin.
Check the attachment of the ECG leads to
the patient.
Check the connection of the ECG
the
leads/SpO
condition.
cannot Restart the monitor and try again, contact
the manufacturer if the connection still
fails.
Restart the monitor and try again, contact
the manufacturer if the connection still
fails.
Measure again, if the fault persists, stop
using the monitor for NIBP measurement,
and contact the manufacturer for repair
Measure again, if failure persists, stop
using the monitor for NIBP measuring and
contact the manufacturer for service.
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transducer and the patient's
2
Alarms
81／202