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Traditional 510(k) of Fetal & Maternal Monitor
F15 Series Fetal & Maternal Monitor User Manual
Chapter8 Maternal Monitoring
1 Do not apply this monitor during electro-surgery or MRI; otherwise it might result in
harming the patient or the operator.
2 Always check if the alarm settings are appropriate for your patient before starting
monitoring.
3 Check for any fault of the transducers before applying them to the patient.
8.1 Maternal ECG Monitoring
8.1.1 Introduction
ECG monitoring produces a continuous wave form of the patient's cardiac electric activity to enable an
accurate assessment of current physiological state. Only proper connection of ECG cables can
ensure a satisfactory measurement.
A 20-second monitor stabilization period shall be allowed before testing. The monitor has Tall T-wave
rejection capability.
The response time of heart rate meter to change in heart rate is less than 10s.
The minute heart rate display is updated at an interval of 1s.
The monitor computes heart rate by excluding the minimum and maximum values from the 12 most
recent RR intervals and averaging the residual 10 RR intervals. If each of three consecutive RR
intervals is greater than 1200ms, then the four most recent RR intervals are averaged to compute the
MHR.
FTS-3 system computes heart rate by averaging the 12 most recent RR intervals.
The monitor or FTS-3 system does not have capability of detecting or rejecting pacemaker pulse, nor
does it provide a pulse to synchronize a defibrillator discharge.
The monitor does not give alarm for tachycardia and cardiac arrhythmia.
The d.c. offset voltage tolerance of the monitor is from -500mV to +500mV. If the d.c. offset voltage of
the detected ECG signal is out of this range, the monitor issues a high priority alarm: ECG SINGNAL
EXCEEDS LIMIT.
1 When connecting the cables and electrodes, make sure no conductive part is in contact
with the ground. Verify that all ECG electrodes, including neutral electrodes, are securely
attached to the patient.
2 The electrodes should be made of the same metal materials.
3 ECG accessories are not suitable for DIRECT CARDIAC APPLICATION (Refer to IEC60601-1
for more information about the definition of DIRECT CARDIAC APPLICATION).
1
A different type of electrode may produce higher offset voltage. Therefore, only use the
ECG leads supplied by the manufacturer when using the monitor for ECG monitoring.
2
Please use EDAN approved disposable electrodes with legal and valid medical device
qualification.
NOTE:
Interference from a non-grounded instrument near the patient and ESU interference can cause
inaccuracy of the waveform.
A good ECG signal should be –
014_14.1_F15_Series_User_Manual
WARNING
WARNING
CAUTION
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After Monitoring
112／202
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