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Fetal Monitor FC-700 Operating Manual
FC-700
OPERATION
MANUAL
Fetal Monitor

Operation Manual

Rev 2.41

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Summary of Contents for Bionet FC-700

  • Page 1: Operation Manual

    Fetal Monitor FC-700 Operating Manual FC-700 OPERATION MANUAL Fetal Monitor Operation Manual Rev 2.41...
  • Page 2 We provide a 1-year warranty period for main body, but Accessory provides a 6 months warranty period.(Two years in Europe) We will repair or replace any part of the FC-700 found to be defective in usual operating circumstance for free to you.
  • Page 3 Fetal Monitor FC-700 Operating Manual How to reach us … The following are telephone numbers and addresses for contacting various service, product supplies and sales personnel Product and Bionet Co.,Ltd. Purchase Address #1101 11F E&C Venture Dream Tower3 38-21, Inquiry Digital-Ro 31-Gil, Guro-gu, Seoul, South Korea (ZIP 152-719) Overseas sales dept.
  • Page 4 Fetal Monitor FC-700 Operating Manual Definition of Warning, Prohibition, Mandatory Action and Note  For a special emphasis on agreement, terms are defined as listed below in operation manual. Users should operate the equipment according to all the Warning and Caution instructions.
  • Page 5 Fetal Monitor FC-700 Operating Manual General Precaution on Environment  Do not keep or operate the equipment in the environment listed below. Avoid placing in an area exposed to moist. Do not Avoid exposure to touch the equipment direct sunlight with wet hand .
  • Page 6 Otherwise, it may cause incorrect result. Self-power line is important for FC-700. To use same power source with other electric instruments may cause incorrect result. Warning statement for class i me equipment indicating: “warning: To avoid risk of electric shock, this equipment must only be connected.
  • Page 7 Fetal Monitor FC-700 Operating Manual Safety Symbols ■ The International Electrotechnical Commission (IEC) has established a set of symbols for medical electronic equipment which classify a connection or warn of any potential hazards. The classifications and symbols are shown below.

  • Page 8: Table Of Contents

    4) Explanation of Sections of Output Sheets ......... 16 5) CardioTocoGraph(CTG) Analysis output paper area ....17 6) Product Installation ..............19 Chapter 2. How to Use FC-700 ........21 1) Basic operation ................21 2) Function of Keys ................21 3) FHR Measurement ...............
  • Page 9 Fetal Monitor FC-700 Operating Manual 3) Error Message ................41 Chapter 6. Specifications .......... 42 Appendix A Maintenance, Care, and Service ..44 Appendix B Ultrasound Power ......... 46 Appendix C Abbreviation and Symbol ..... 50 Appendix D Electromagnetic Emissions and Immunity - Manufacturer’s declaration ....

  • Page 10: Chapter 1. General Information

    LED. Also, FC-700 provides the sound from the heart of fetus. FC-700 measures the uterine contraction of a pregnant woman by pressure sensors and displays the numerical values. And FC-700 records the heart rate of the fetus, fetal movement and the values of uterine contraction.  Intended use...
  • Page 11 - A warning statement addressing hazards that can result from unauthorized modification of me equipment according to following examples: only can fix the Service person of Bionet. Power supply is specified as a part of ME Equipment. Safety Symbols Marked on the Package...
  • Page 12 Fetal Monitor FC-700 Operating Manual Main Body configuration ▣ Top view ① ② ③ ④ ⑤ ① Hand Grip ② Printer door ③ Printer door release button ④ Display LED ⑤ Control panel Rev.2.41...

  • Page 13: Front View

    Fetal Monitor FC-700 Operating Manual ▣ Front view ① ① Printer door release button ▣ Rear view ○, ○, ○, ○, ○,1 Power adaptor connection port ○,2 Power on/off switch ○,3 RS-232C serial port ○,4 Mark Jack connection port Prohibition Please instruct the operators to avoid contact with both the RS-232C Serial port area and the patient simultaneously.
  • Page 14 ① Hand Grip ▣ Right side view ① ① Doppler, UC Probe connection port Note To avoid an expected electric shock, do not open the equipment cover or disassemble the equipment. Refer servicing to qualified personnel of Bionet Co., Ltd. Rev.2.41...
  • Page 15 Fetal Monitor FC-700 Operating Manual ▣ Control Panel ① ② ③ ④ ⑤ ⑥ ⑦ ⑧ ⑨ ⑩ ① Heart rhythm symbol (Green : stable, Red : unstable). ② Heart rate of the fetus (bpm). ③ UC measurement value. ④ Volume up/down key. During the use of the Menu for setup, this key is used to change the setting value.

  • Page 16: Explanation Of Sections Of Output Sheets

    Fetal Monitor FC-700 Operating Manual 4) Explanation of Sections of Output Sheets ① Fetal heart rate per minute ② Fetal movement point that is indicated when Event Marker is pressed ③ Uterine contraction ④ Information on the recording condition ⑤...

  • Page 17: Cardiotocograph(Ctg) Analysis Output Paper Area

    Fetal Monitor FC-700 Operating Manual 5) CardioTocoGraph(CTG) Analysis output paper area (Option) ① ② CTG Analysis results is printed out every 10 minute. (Intermediate Report) Start printing by pressing print button in order to analyze CTG and repress print button to stop printing process.
  • Page 18 Fetal Monitor FC-700 Operating Manual < Final Report > CTG REPORT (PERIOD : 0 - 15 MIN 0 SEC) AVERAGE BASELINE FHR(BPM) : 123 bpm NUMBER OF UC(FREQUENCY) : 5/ 20.0/h NUMBER OF ACC(FREQUENCY) : 0/ 0.0/h NUMBER OF DEC(FREQUENCY) : 5/ 20.0/h...

  • Page 19: Product Installation

    If you put the plug of power adaptor in the terminal of power adaptor of the main body of FC-700 and then switch it on, the equipment will work. If the power supply is normal, LED at the operation panel indicating Power On/Off will be turned on green.

  • Page 20: Software Version

    ▣ Setting of Recording Paper If you release the button to open the printer cover at the front of FC-700 to the right, it will open. Put recording paper with the recording part on the upper side adjusting the paper roll parallel to the print direction and then close the cover.

  • Page 21: Chapter 2. How To Use Fc-700

    Chapter 2. How to Use FC-700 1) Basic operation ① Put the plug of FC-700 in an outlet and switch it on. ② Check setup values if they are set as wished. ③ Change the setup values, as you want.

  • Page 22: Fhr Measurement

    Fetal Monitor FC-700 Operating Manual ▣ LAMP POWER: If it is switched on, the lamp will be turned on green. ALARM: If the alarm is on, the lamp will be turned on red. RECORD: During printing, the lamp will be turned on green.
  • Page 23 Fetal Monitor FC-700 Operating Manual Note When the Doppler Probe is put not on the back but on the breast part of a fetus, accurate ultrasonic waves can’t be caught from the fetal heart and the fetal heat beat can be frequently missed.

  • Page 24: Uc Measurement

    Fetal Monitor FC-700 Operating Manual 4) UC Measurement UC (Uterine Contraction) can be measured with an externally attached pressure sensor. If the UC Probe is put on the abdomen of a pregnant woman, it measures a relative pressure changing according to the uterine contraction and records uterine contraction.

  • Page 25: Measurement Of Fetal Movements

    Fetal Monitor FC-700 Operating Manual 5) Measurement of Fetal Movements ▣ How to Use Event Marker Even Marker relys on the recognition of a pregnant woman to record a fetal movement point: when she feels a fetal movement, press a button on Event Marker. When Event Marker is pressed during recording, the fetal movement point is indicated with an arrow mark on recording paper with a signal of “Beep~”...

  • Page 26: Recording

    Fetal Monitor FC-700 Operating Manual 6) Recording The recording functions include AUTO NST (Non-Stress Test) and monitoring. The AUTO NST function that records FHR, UC, and fetal movements for the period of established time and stops automatically is effective in the non-contraction test. The monitoring function enables a user to operate Start/Stop of recording.

  • Page 27: Fhr Alarm

    Fetal Monitor FC-700 Operating Manual 7) FHR Alarm If FHR beyond the established upper or lowest limit of normal FHR exceeds the established delay time, an alarm is made. ▣ Order to Use the FHR Alarm Function ① Use the Volume Up/Down Key to set the value of “H” menu which means the upper limit of FHR and that of “L”...

  • Page 28: Equipment State Alarm

    Fetal Monitor FC-700 Operating Manual 9) Equipment State Alarm The following circumstances raise a signal of “Ding-dong~” to ask a user to pay attention: ① The contacter of Doppler Probe in use is disconnected from the main body (Er1) ② Out of paper during recording (Er2) ③...

  • Page 29: Chapter 3. Setup Modes

    Fetal Monitor FC-700 Operating Manual Chapter 3. Setup Modes The setup modes include those of alarm/time, recording, and factory. The factory setup is a part having great effect on the performance of the equipment if the set-up value is easily changed;...
  • Page 30 Fetal Monitor FC-700 Operating Manual ▣ How to Set the Date and Time ① To set the year, press the Alarm key for over two seconds and then the Reference key to indicate the following. It indicates that the current year is 2002.
  • Page 31 Fetal Monitor FC-700 Operating Manual ④ To set the hour, press the Alarm key for over two seconds and then Reference key to indicate the following. It indicates “ 1 o’clock “ now. Use the Volume Up/Down Key to change the set-up hour. Press the Record Key to store the changed value and then return it to the basic state after a signal of “Ding-dong”.

  • Page 32: Recording Setup

    The output speed can be set at one of 1, 2, and 3 cm/min, and may be changed with the Volume Up/Down Key. ② Thermal paper for a facsimile can be used for FC-700 besides those supplied. To use those for a facsimile, press the Reference key for over two seconds and then for a short time to indicate the following.
  • Page 33 Fetal Monitor FC-700 Operating Manual ③ To control the contrast of graph, press the Reference key for over two seconds and then for a short time to indicate the following. Select 1 for a medium and 2 for the darker state, and use the Volume Up/Down Key to change it.
  • Page 34 Fetal Monitor FC-700 Operating Manual ▣ How to set Cardio-Toco Graph(CTG) analysis function Press REFERENCE button for at least 2 seconds and repress REFERENCE button for a short amount of time in order to set automatic CTG diagnosis function. It should appear like the figure below.
  • Page 35 Fetal Monitor FC-700 Operating Manual ▣ How to set Demo mode Press REFERENCE button for at least 2 seconds and repress REFERENCE button for a short amount of time in order to set Demo mode. It should appear like the figure below. Use the Volume Up/Down Key to change it.

  • Page 36: Factory Setup

    Fetal Monitor FC-700 Operating Manual 3) Factory Setup ▣ How to Set the FHR Alarm Delay To set the FHR alarm delay, switch it off (and then press the Volume Down key) and switch it on again pressing the Volume Up key. Then, the following appears which indicates that the alarm delay time (‘t’) is set at ten minutes.

  • Page 37: Chapter 4. Ctg Terminology

    Fetal Monitor FC-700 Operating Manual Chapter 4. CTG Terminology 1) Baseline FHR Mean FHR rounded to increments of 5 bpm during a 10 minute segment excluding periodic or episodic changes, periods of marked variability and, segments of baseline that differ by >25bpm.
  • Page 38 Fetal Monitor FC-700 Operating Manual 4) EARLY DECELERATION Visually apparent gradual decrease(onset to nadir is ≥ 30 sec.) of FHR below baseline. Return to baseline associated with a uterine contraction. Nadir of deceleration occurs at the same time as the peak of the contraction. Generally, the onset, nadir, and recovery of the deceleration occur at the same time as the onset, peak and recovery of the contraction Rev.2.41...
  • Page 39 Fetal Monitor FC-700 Operating Manual 5) Variable DECELERATION Visually apparent abrupt decrease ( onset to nadir is <30sec) in FHR below baseline. Decrease is ≥15 bpm. Duration is ≥ 2 min and < 10 min. Rev.2.41...

  • Page 40: Chapter 5. Trouble Shooting

    Chapter 5. Trouble shooting 1) Maintenance and Cleaning You can keep FC-700 clean in many different ways. Use the following recommendations to avoid the damage or stain to the machine. If the material (not approved material) that may cause damage to the product is used, the product is not guaranteed even within the period of guarantee is not expired.

  • Page 41: Regular Inspection

    1) When DOP Probe does NOT work, it is connected to the other channel or exchange the DOP Probe. Also equal UC Probe. 2) If equipment does NOT work, you have to make a phone call service person of Bionet. For more information, see the Service Manual.

  • Page 42: Chapter 6. Specifications

    Fetal Monitor FC-700 Operating Manual Chapter 6. Specifications Environmental Specifications Operating Temperature：15°C to 30°C (59°F to 86°F) Storage Temperature：- 10°C to 60°C (14°F to 140°F) Operating/Storage Humidity：20% to 95% RH, non-condensing Operating Altitude：70(700) to 106Kpa(1060mbar) Power Specifications Power Adaptor ;...
  • Page 43 Fetal Monitor FC-700 Operating Manual Recorder Recorder Method : Thermal Array Type Resolution: 8(vertical)/10(horizental) dot/mm Print Speed : 1, 2, 3 cm/min Paper Feeding Function Paper Grid : On/Off Print Contrast : 1, 2 Auto Print Period : 0, 10, 20, 30, 40, 50, 60...

  • Page 44: Appendix A Maintenance, Care, And Service

    Fetal Monitor FC-700 Operating Manual Appendix A Maintenance, Care, and Service Mechanical hazard Warning Ultrasound probes are highly sensitive medical instruments that can easily be damaged by improper handling. Use care when handling and protect from damage when not in use.
  • Page 45 Do not to touch signal input, signal output or other connectors, and the patient simultaneously. Refer servicing to qualified personnel of Bionet Co., Ltd. Probe acoustic output hazard Warning Ultrasound can produce harmful effects in tissue and potentially result in patient injury.

  • Page 46: Appendix B Ultrasound Power

    Fetal Monitor FC-700 Operating Manual Appendix B Ultrasound Power Use of Diagnostic Ultrasound The American Institute of Ultrasound in Medicine (AIUM) has published a document entitled "Medical Ultrasound Safety". This three part document covers Bioeffects and Biophysics, prudent Use and Implementing ALARA.
  • Page 47 Fetal Monitor FC-700 Operating Manual Maximum Probe Temperature (Degrees C) Probe Max Temperature With TMM In Air Mode Phantom 33.8 23.6 PWD Mode Lens temperature monitored for 30 min. Measurement uncertainty: +-0.5 degree C. Ambient temperature : 23.5 degree C Table Key Meaning IEC60601-2-37 / FDA&NEMA...
  • Page 48 Fetal Monitor FC-700 Operating Manual Output Power / Time average acoustic power at the source Attenuated Output Power / Time average Pα W.3(Z) acoustic power derated to depth z Bounded Output Power / Power emitted from the central 1cm of aperture...
  • Page 49 Fetal Monitor FC-700 Operating Manual Acoustic Output Tables MC65R1S – Pulsed Doppler Mode Index scan Non-scan Non-scan Aaprt<= 1 Aaprt > 1 Global Maximum : Index Value 0.014874 0.010567 0.166265 0.178513 Unit Associated pr.3 (MPa) 0.0148732 Acoustic (mW) 43.7 43.7 43.7...

  • Page 50: Appendix C Abbreviation And Symbol

    Fetal Monitor FC-700 Operating Manual Appendix C Abbreviation and Symbol Abbreviation and Symbol of manual or system operation is arranged in alphabetical order. Abbreviations alternating current Celsius cm, CM centimeter direct current electromagnetic compatibility electromagnetic interference Fahrenheit gram heart rate, hour...
  • Page 51 Fetal Monitor FC-700 Operating Manual kg, KG kilogram liter, left lbs, LBS pounds liquid crystal display light emitting diode M mean, minute meter MIN, min minute MM, mm millimeters MM/S millimeters per second MMHG, mmHg millimeters of mercury millivolt second...
  • Page 52 Fetal Monitor FC-700 Operating Manual multiplier when used with a number (2X) Symbols & ° degree(s) > greater than < less than – minus number percent ± , +/- plus or minus Rev.2.41...

  • Page 53: Appendix D Electromagnetic Emissions And Immunity - Manufacturer's Declaration

    Electromagnetic Emissions and Immunity Manufacturer’s declaration - electromagnetic emission The FC-700 system is intended for use in the electromagnetic environment specified below. The customer or the user of FC-700 system should assure that it is used in such an environment Emission test...
  • Page 54 Note: Uт is the a.c. mains voltage prior to application of the test level. The FC-700 system is intended for use in the electromagnetic environment specified below. The customer or the user of the FC-700 system should assure that it is used in such an environment Immunity test...
  • Page 55 Fetal Monitor FC-700 Operating Manual Radiated RF 3 V/m 3 V/m Recommended separation IEC 61000-4-3 80.0 MHz to 2.5 80.0 MHz to 2.5 distance Where P is the maximum output power rating of the transmitter in watts (W) according to the...
  • Page 56 Equipment and the FC-700 system. The FC-700 system is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The user of the FC-700 system can help prevent electromagnetic interference by maintaining a minimum distance between portable...
  • Page 57 Guidance and manufacturer’s declaration - electromagnetic immunity The FC-700 system is intended for use in the electromagnetic environment specified below. The customer or the user of the FC-700 system should assure that it is used in such an environment Immunity test...
  • Page 58 Name : Tel : Sales Agency Manufacturer ※ Thank you for purchasing FC-700. ※ This product is manufactured and passed through strict quality control and inspection. ※ Compensation standard concerning repair, replacement, refund of the product complies with “Consumer’s protection law” noticed by Economic Planning Dept.
  • Page 59 Fetal Monitor FC-700 Operating Manual International Sales & service Bionet Co., Ltd. : #1101 11F E&C Venture Dream Tower3, 38-21, Digital-Ro, 31-Gil, Guro-Gu, Seoul, 152-719, Republic of Korea Tel : +82-70-7585-6418 / Fax : +82-2-6499-7789 / e-mail: sales@ebionet.com Website: www.ebionet.com U.S.A sales &...

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