eCTG-8M Fetal/Maternal Monitor User Manual Version:V1.0 Date:2019.
About User Manual Shenzhen Luckcome Technology Inc., Ltd bears no responsibility or not guarantee for the occasional or indirect damage caused by using of eCTG-8M. Luckcome bears no responsibility for any result caused by using for other purpose. No one can photocopy, copy or translate into other languages without Shenzhen Luckcome Technology Inc., Ltd written approval. The information of this manual can be changed without prior notice. Warning: This is not treatment device.
Remark: Warning: User should know that how to avoid damage on patient and clinicians. Caution: User should know that how to avoid damage on devices. Note: User should know some important information. IPX1 closed instrument with water drop proof function. BF type applied part against electric shock. ：Refer to attached User Manual. Waste Electrical and Electronic Equipment Directive 2002/96/EC (WEEE Directive). ： Non-Ionizing Radiation Manufacture’s serial number. class II equipment .
Table of Content Table of Content 1 Prefix .................................................................................................................................................................. 4 1.1 Introduction ............................................................................................................................................... 4 1.2 Safety Guidance .......................................................................................................................
Prefix 1 Prefix 1.1 Introduction Fetal/Maternal Monitor is mainly composed of ultrasound probe, uterine contraction probe, charging seat and power adapter. It is suitable for continuous monitoring of fetal heart rate and uterine contraction pressure during perinatal period. The probe has a display screen to display the current fetal heart rate and uterine contraction pressure. 1.2 Safety Guidance Probes in this system are devices of internal power supply. It is BF applied parts .
Prefix delicate components and should be treated with care. This applies especially to the transducers which should not be dropped or knocked. Caution: The use of water-based gel supplied by certificated suppliers is strongly recommended. Oil based gels can damage the transducer and must not be used. The use of oil based gels will invalidate your warranty. Caution: Excess gel should always be wiped off after use.
Prefix Contraindications: Do not use during Defibrillation, Electrosurgery or Magnatic Resonance Imaging (MRI).
Working Station Software 2 General Information 2.1Product and Working principle eCTG-8M consist of ultrasound probe, TOCO probe,Charging socket and power adapter. This working principle: Ultrasound beams produced by ultrasound transducer reach the surface of fetal heart movement. Due to Doppler effect, the frequency of ultrasound frequency shifts. The frequency shifts are detected by the receiving transducer. After signal processing, the low frequency signals related to fetal heart are separated.
Probe 3 Probe 3.1 Probe and Charging Socket Ultrasound Probe Sound output holes Sound switch Screen TOCO probe Screen Charging socket LED indicator 3.2 Display BED XX : Probe ID US1: FHR Probe type ：Probe battery status ---: FHR or TOCO value ：Charging ：Turn off probe sound， ：Turn on probe sound Central software is not activated and running.
Probe ：Monitoring is not started yet. ：Started monitoring. 3.3 Charging Probes are with rechargeable battery. If battery runs out of power, charge it. Charging time: about 80minutes Continuous working hour: about 5 hours. Connect charging socket with AC power, put probe onto charging socket, start charging. During charging, charging grid on battery sweeps; After fully charging, stop sweeping. Caution: During charging, instrument can not proceed monitoring.
FHR Heart Monitoring 4 Fetal Heart Monitoring 4.1 Fetal Heart Monitoring FHR monitoring is achieved basing on the Doppler Effect. We know that a certain frequency of ultrasonic will be reflected when encountering obstacles in the transmission. If the object is stationary, the reflected wave and the transmitted wave have the same frequency. Once the object moves, the reflecting frequency will change.
FHR Heart Monitoring can be heard, the FHR value will be on display continuously. Then tie the probe here. If probe change its place during monitoring, adjust it to get best signal. Note: Please use certified Gel. Fetus Heart Location reference: Phase I 16-24W Phase II 24-32W Phase III 32-40W 4.2 TOCO Monitoring Uterine contraction pressure monitoring is to measure uterine activities by placing a TOCO transducer on the abdomen of pregnant woman.
Maintenance 5 Maintenance 5.1 Maintenance Before using the instrument, please check if there is any damage of equipment that may affect the patient’s safe or the instrument performance. If an obvious damage (broken enclosure or damaged cable) is found, it should be solved or replaced before use. This instrument has passed professional Medical Testing Laboratory safety test. User can use without concern within its lifetime. The accuracy of FHR is decided by machine itself and cannot be adjusted.
Specifications 6 Specifications Model: eCTG-8M Type of against electrical shock: internal power device Level of against electrical shock: BF applied part Degree of against liquid: Probe IPX1 Safety of anti-flammable gas: can not be used in flammable gas. Working Mode: Continuous working EMC: Class 1 B General Information: Size: 0.96 dual color OLED display Resolution: 128*64 Battery: 3.
Accessories List Appendix I Accessories List ID Name Ultrasound Probe TOCO probe Charging socket Power adapter USB Cable 14 /20
Accessories List Appendix 2 Acoustic Output Reporting Table 15 /20
Accessories List Appendix 3 Guidance and Manufacturer’s EMC Declaration 16 /20
Accessories List 17 /20
Accessories List 18 /20
Accessories List 19 /20
To ensure your Warranty service, please fill in following Warranty Card: Warranty Card Product Name Model No. Serial No.
FCC Statement： This device complies with part 15 of the FCC rules Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. NOTE: The manufacturer is not responsible for any radio or TV interference caused by unauthorized modifications to this equipment. Such modifications could void the user’s authority to operate the equipment.
