F15 Series Fetal & Maternal Monitor User Manual Monitoring Mother and Ferus Using FECG
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and regulations. Do not discard them randomly.
8 Electrodes are for one-off use only as they may cause cross infection between different
patients. Repeated use is forbidden!
9 Clean the ECG leads before monitoring.
9.2.5 Connecting the ECG Leads to the Electrodes
Straighten out the leads and avoid tangling or bending. Connect the leads to the electrodes
according to the color and make sure that the connection is tight.
WARNING
1 Only the patient cable and other accessories supplied by the manufacturer can be used.
Or else, the performance and safety cannot be guaranteed.
2 Monitoring can only be started when all the ECG leads are connected correctly and signal
is normal.
CAUTION
Please use EDAN approved disposable electrodes with legal and valid medical device
qualification.
9.2.6 Placing the Transducer
When monitoring uterine activity by pressure sensor of the transducer, put the transducer on the
patient’s fundus, which is flat and solid.
When monitoring uterine activity by EMG signal, then no special requirement for the location of the
transducer.
Wrap the abdomen with the belt over the transducer. Fix the transducer by pushing its buckle through
the overlapping section of the belt. Make sure the belt fits the patient snugly but comfortably.
WARNING
When monitoring uterine activity by EMG signal,
1 The monitor may display deflections from baseline that do not represent uterine
contractions. These deflections from baseline may represent electrical activity in the
myometrium that is not sufficiently organized to cause the uterine smooth muscle to
contract. When this occurs, the “false contraction” often does not attain the amplitude of
true uterine contractions. If the waveform looks suspicious, another method of monitoring
should be considered.
2 Sometimes low amplitude electrical activity insufficient to cause a contraction detected by
a pressure sensor is displayed as a deflection above baseline on the waveform. These
Traditional 510(k) of Fetal & Maternal Monitor
014_14.1_F15_Series_User_Manual
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