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ShenZhen Luckcome Technology Inc., Ltd OCT BABY iFM-10B Series User Manual

Fetal doppler
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OCT BABY
iFM-10B Series Fetal Doppler
User Manual
Version No.: V1.0
Date: 2015. 03
File No.: 503-020048-011

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Summary of Contents for ShenZhen Luckcome Technology Inc., Ltd OCT BABY iFM-10B Series

  • Page 1 OCT BABY iFM-10B Series Fetal Doppler User Manual Version No.: V1.0 Date: 2015. 03 File No.: 503-020048-011...

  • Page 2: Table Of Contents

    iFM-10B Series Fetal Doppler User Manual Table of Content 1 Safety Guide..................2 2 Product Introduction...............4 2.1 General Information.............4 2.2 Features................4 2.3Configurations...............4 3 Transducer and software..............5 3.1 Transducer................5 3.2 Software................6 4 Device Operations.................14 4.1FHR Monitoring..............14 4.2 Fetal Heart Positioning............15 4.3 Fetal Movement..............

  • Page 3: Safety Guide

    iFM-10B Series Fetal Doppler User Manual 1 Safety Guide This device is internally powered equipment, and the degree of protection against electric shock is Type B applied part. It is IPX1 transducer. Before use it, please check its lifetime. Its lifetime is 5 years and manufacturing date is labeled at the bottom side of device.
  • Page 4 iFM-10B Series Fetal Doppler User Manual Warning: The efficient working distance is 5 meters. Caution: This instrument must be maintained by qualified engineers. Caution: This instrument is designed to work continuously, and water drop proof type, and be care to avoid to be splashed.
  • Page 5 iFM-10B Series Fetal Doppler User Manual government regulations:  Check if there is mechanical or functional damage  Check if safety labels are clear  Check its function works in compliance with user manual. Caution: When the device is out of its lifetime, follow local laws to return to manufacturer for recycling.

  • Page 6: Product Introduction

    iFM-10B Series Fetal Doppler User Manual 2 Product Introduction 2.1 General Information iFM-10B series Fetal Doppler is hand-held monitoring devices. It is made of main unit including battery, transducer and APP software. It is applicable for monitoring of fetal heart rate. Model No.

  • Page 7: Configurations

    iFM-10B Series Fetal Doppler User Manual  Fetus Heart Sound output through mobile phone  App software features with review, share and antenatal training music. 2.3Configurations USB cable ……………………………………………………1piece Audio cable…………………………………………………1piece Ultrasound transducer…………………………………1 piece User Manual, Warranty Card……………………….. 1set...

  • Page 8: Transducer And Software

    iFM-10B Series Fetal Doppler User Manual 3 Transducer and software 3.1 Transducer ② ① Ultrasound side ③ ④ ⑤ Fig 3-1 Transducer Appearance Transducer: Receive fetal heart signal FHR and power indicator FHR (110bpm-160bpm), green FHR(less than 110bpm, over 160bpm), yellow Power recharge: orange flashing...

  • Page 9: Software

    iFM-10B Series Fetal Doppler User Manual Power recharge finished: Green On/off switch Press it for 5 seconds for power on and off the device, the Bluetooth function on/off during the device on/off. Mini USB port: connect USB cable ⑤ Audio output 3.2 Software 3.2.1 Software Introdution This software runs at front-page of the smart phone.
  • Page 10 iFM-10B Series Fetal Doppler User Manual will give confirmation notice. Initial Version No. is 1.0; Luckcome provide hardware maintenance only; Any software issue, go to Android website for upgrade; Any software issue does not damage SD card; before upgrade, user need to backup information on SD card as the mother information is stored there.
  • Page 11 iFM-10B Series Fetal Doppler User Manual resolution is 1280*720 or higher. SD card space is over 50M space . 3.2.3 Software Interface Click , enter software. New user will see following interface: Input ”Due Date” Input ”Name” Click “Next”, go to next interface Service Agreement Fig 3-2 1...
  • Page 12 iFM-10B Series Fetal Doppler User Manual 1 ） Please check and review “Service Agreement” firstly, understand related service terms, then input “Due Date” and “Name”. After input, see following interface: Fig 3-3 Input “Due Date” Fig 3-4 Input “Name”...
  • Page 13 iFM-10B Series Fetal Doppler User Manual Note: It is a must to input “Due Date”, because all the monitoring data are named by gestation week; gestation week come from Due Date. 2）Click “Next”, if user do not input ”Due Date” and “Name”, it will prompt following interface: “Input “Due Date and Name”...
  • Page 14 iFM-10B Series Fetal Doppler User Manual 3 ） After input “Due Date” and “Name”, click “next”, see “Bluetooth connection” interface. Click to activate communication: Fig 3-7 Bluetooth Connection All wireless devices have distance limitation to ensure stable data communication. Blue tooth distance limitation is less than 10meters; we recommend less than 5 meters between this device and smart...
  • Page 15 iFM-10B Series Fetal Doppler User Manual phone. Longer than 5 meters, sound output may become non-continuous and will be interfered by other Bluetooth devices. That is normal situation, not device failure. When log in OCT Baby software, Bluetooth function at smart phonies not on, it prompt “Connection failed”;...
  • Page 16 iFM-10B Series Fetal Doppler User Manual If no response, system will give message “Network error”. Click to store the data; click again to stop storage. Fig 3-8 Monitoring Interface 5) Click “Record”, go to record interface to view the record.
  • Page 17 iFM-10B Series Fetal Doppler User Manual Fig 3-9 Record Review Fig 3-10 Share...
  • Page 18 iFM-10B Series Fetal Doppler User Manual Fig 3-11 Antenatal Training Music 6）Click , go to music interface ( see Fig 3-11). User can listen to built in music; or copy favorable music to this folder for listening. 7) At monitoring interface, Click , go to “More”:...
  • Page 19 iFM-10B Series Fetal Doppler User Manual Return----Go back to monitoring interface Website----Go to www.luckcome.come User Manual----Open User Manual( PDF format) Delivery Date---- Display preinput delivery date, clickitif you want to revise the delivery date. After delivery, gestation week at history record will change. Name: Display pre input name;...
  • Page 20 iFM-10B Series Fetal Doppler User Manual name. Feedback --- Go to email interface to write email. Check and update --- Check software version. If there is new softwre, message prompt to remind user for update software. Click “Yes” to update software. After updating, smart phone will auto reactivate the new software;...

  • Page 21: Device Operations

    iFM-10B Series Fetal Doppler User Manual 4 Device Operations 4.1FHR Monitoring Press on the transducer, activate the software. For 1 time use, user need to input “Due Date” & “Name”. If connection succeed, it will go to monitoring interface automatically. Note: If user forget to press on the transducer, or the transducer power is not enough, it cannot process normal monitoring.

  • Page 22: Fetal Heart Positioning

    iFM-10B Series Fetal Doppler User Manual Fig 4-1 Monitoring Interface Interface Introduction: Gestation week will be counted automated by this software according to “Due Date”. Click , start monitoring, click again, stop monitoring. Fetal Movement Marker button Monitored time Flashing during monitoring Fetal Heart signal status( strong or weak signal) 4.2 Fetal Heart Positioning By touch, find position where heart beats is strong;...
  • Page 23 iFM-10B Series Fetal Doppler User Manual Usually, for the earlier gestational weeks, the fetal heart position is always at 1/3 between navel and pubis, as the fetus grows up, the position will move up, and will be at left or right slightly due to different fetus position.

  • Page 24: Fetal Movement

    iFM-10B Series Fetal Doppler User Manual Phase I: Gestation week: 16-24 Phase II: Gestation week: 23-32 Phase III: Gestation week: 32-40 After regular fetal heart beating is heard, click , start monitoring. 4.3 Fetal Movement ， this During monitoring, if mother feel fetal movement, click software will make the icon at the horizontal level of FHR210.
  • Page 25 iFM-10B Series Fetal Doppler User Manual During review, user can drag the FHR waveform to left or right. Click , waveform will move, and acommpany with sound outpout. Click , stop wave movement and sound output. Total display time/Total time. Click “Return”...

  • Page 26: Power Recharge

    iFM-10B Series Fetal Doppler User Manual Click , go to share interface. User can share the reviewing record with others. 4.5 Power recharge This fetal Doppler is equipped with rechargeable Li-Ion battery. If batter is running out of power, please recharge it as per following instructions: 1) Connect USB cable, one end to USB port of fetal Doppler;...
  • Page 27 iFM-10B Series Fetal Doppler User Manual indicator is orange flashing; after finish charging, power charging indicator turns to green. Note: User can not open the device to take out battery without permit. Note: If the device is not in use for a long time, please take out the battery to extend battery lifetime.

  • Page 28: Technical Data

    iFM-10B Series Fetal Doppler User Manual 5 Technical Data Product Name: Fetal Doppler Model: iFM-10B Classify: Protection against electric shock: internal power supply, type B: Protection against liquid: normal device, (Probe IPX1), do not have waterproof ability; Protection against flammable gas: not suitable for using in the environment with flammable gas;...
  • Page 29 iFM-10B Series Fetal Doppler User Manual Humidity: < 93％ Atmospheric pressure: 86kPa - 106kPa Capability of fetal heart rate: Measurement range: 50 ~ 210bpm Accuracy: ±2bpm Speaker power: 1W Battery: 3.7V rechargeable Li-Ion battery Ultrasonic probe: Working mode: Continuous Doppler Waterproof: IPX1 Acoustic-working frequency: 2.5MHz ±15％...

  • Page 30: Maintenance

    iFM-10B Series Fetal Doppler User Manual 6 Maintenance 6.1 Maintenance The acoustics of ultrasonic probe is a precise instrument that we should handle them gently. Washing the Gel left on transducer after using is very useful for extending the service life of this instrument.
  • Page 31 iFM-10B Series Fetal Doppler User Manual The accuracy of FHR is decided by machine itself and can not be adjusted. If you are suspicious of accuracy of result, you can verify it through other devices like a stethoscope; also you can contact local distributors or manufacturers for help.
  • Page 32 iFM-10B Series Fetal Doppler User Manual Caution: Do not immerse instrument in any liquid Caution: Do not splash any liquid into the instrument when cleaning Caution: Do not leave any cleaning liquid on the surface Note: The probe surface may be use 70% alcohol or Isopropyl alcohol to wipe, dry it in natural air or clean it by a clean, soft cloth.

  • Page 33: Warranty

    iFM-10B Series Fetal Doppler User Manual 7 Warranty All maintenances of this instrument should be operated by professional technical persons. The warranty period is 1 year (from the purchased date). All the failures caused by the material failure or production problem are within the warranty range. And all the failed parts are free replaced and repaired.

  • Page 34: Storage And Transportation

    iFM-10B Series Fetal Doppler User Manual assumes no responsibility for errors contained herein or for any damage to the user resulting from accidents or any other reasons during operation of the user’s unit according to this material. Note: This User Manual contains special files which are protected by related laws.
  • Page 35 iFM-10B Series Fetal Doppler User Manual hurt to the patient and doctor. Caution: you should know this information about how to protect the instrument. Note: you should know this important information. : Refer to User Manual : B type applied part Waste Electrical and Electronic Equipment Directive 2002/96/EC (WEEE Directive).

  • Page 36: Tips For Fetal Monitoring

    iFM-10B Series Fetal Doppler User Manual Tips for Fetal Monitoring 1. Modern medicine proves that the asphyxia, fetal distress and umbilical cord around neck (25% of pregnant has such situation) will affect the normal growth and life of fetus, sometime it endangers the life of mother.
  • Page 37 iFM-10B Series Fetal Doppler User Manual Remark: The applicant will display the detail FCC ID label in the formal user’s manual of the product. That will be show: FCC ID:2AG9TLKNIFM10B Made in China 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...
  • Page 38 iFM-10B Series Fetal Doppler User Manual e harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installat ion. If this equipment does cause harmful interference to radio or t elevision reception, which can be determined by turning the equip ment off and on, the user is encouraged to try to correct the interfe rence by one or more of the following measures: –...
  • Page 39 iFM-10B Series Fetal Doppler User Manual In order to protect your right for repair service, please take a few moments to fill out the warranty card below: Warranty Card Product Model No. Serial No. DateofPurchase Warranty Period Name Customer Address Information □Network □Exhibition □Magazine Resource...

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