F15 Series Fetal & Maternal Monitor User Manual Monitoring Mother and Ferus Using FECG
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WARNING
4 If montoring TOCO with the pressure sensor, inspect patient skin before applying the
transducer. If the skin quality is poor, especially when the skin is damaged or irritated,
please change a site to apply the transducer.
5 In the process of labor, excessive movement of the pregnant woman will influence the
calculation of the HR.
6 If you cannot get a good measurement signal quality, use an alternative monitoring
method.
7 During long-time TOCO monitoring with the pressure sensor, please inspect the
application site of the transducer at least every half an hour. If the skin quality changes,
you should move the transducer to another site.
8 Do not monitor with FECG if :
a. The skin on the abdomen of the patient has established erythema, lesions, infection,
inflammation, or any kind of injuries at the applications site
b. The patient has a history of skin irritation, allergies, or hypersensitivity to adhesives.
9 The FECG Fetal&Maternal Module detects fetal and maternal parameters based on ECG
principle. The ECG signal is extremely sensitive to electromyography interference
generated by tense muscles, or interference generated by maternal or fetal movement that
leads to deflections from baseline. So when the pregnant woman pushes during
contractions, moves when wearing the device or sits on the birth ball, the interference
generated will cause the monitor unable to calculate the correct FHR/MHR.
10 During the second stage, the pregnant woman pushes with all her strength to deliver the
fetus, and the muscles are in tense status for a long time. The EMG interference generated
may cover the maternal/fetal ECG signals and in the end the correct FHR/MHR is unable to
be calculated. So if FHR/MHR hasn’t been detected for a long time during this stage, it’s
suggested to change the monitoring method to ultrasound for or DECG monitoring.
11 Doctor should examine carefully the monitoring data of the pregnant woman.
12 FECG Fetal&Maternal Module has priority over F15 Air US Transducers, DECG Fetal &
Maternal Module and TOCO transducer. When FECG Fetal&Maternal Module gets on line,
F15 Air US Transducers, DECG Fetal & Maternal Module and TOCO transducer will be
disabled.
9.2.2 Parts Required
①FECG Fetal&Maternal Module and ECG leads ② Electrodes ③Skin prep tape
9.2.3 Skin Preparation
The skin is poor conductor of electricity; therefore preparation of the patient's skin is important to
facilitate good electrode contact to skin.
If the women has been using creams, or coupling gel, remove any residue with wet tissues and
make sure the skin where electrodes will be placed is dry.
Select area without any injury or any abnormality
Avoid area with hair. Shave hair from electrode sites, if necessary.
Using the skin prep tape and make three vertical and three horizontal strokes (making a cross
shape) on the area where the electrode will be placed (remove the dead skin cells below the
electrode foam gel pad). For most women 3 strokes in 2 directions should be sufficient.
Traditional 510(k) of Fetal & Maternal Monitor
014_14.1_F15_Series_User_Manual
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