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FC1400 User Manual

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FC1400 Operation Manual

▣

Intended Use

FC1400 is a fetus monitoring device used to measure Fetal Heart Rates (FHR), degree of maternal

uterine contraction (UA: Uterine Activity), fetal movements (FM). FC1400 shoots ultrasounds to the

abdomen of the patient. From the signals returned after being reflected by the heart of the fetus,

FC1400 extracts Doppler frequencies that vary with the movements of the heart of the fetus to output

changes in the heartbeats of the fetus as sounds for the analysis of the signals; thus detecting the

heart rates and fetal movements of the fetus. In addition, it detects the degrees of uterine contraction

of the patient using a pressure sensor. It indicates the fetal heart rates, maternal uterine activity, fetal

movements, on its LCD screen as figures and saves the information to its memory.

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Claimed indications

- Previous history of stillbirth

- Complications of pregnancy

- Induction of Labor

- Preterm labor

- Nonreassuring fetal status; fetal movement

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Contraindications

: Unknown

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Monitor Environmental Specifications

· Operating Temperature

：

15°C to 40°C (59°F to 104°F)

· Storage Temperature

：

- 10°C to 60°C (14°F to 140°F)

· Humidity

：

20% to 95% RH

· Operating Attitude

：

70(700) to 106Kpa(1060mbar)

Содержание FC1400

Страница 1: ...FC1400 Operation Manual Ver 2 04 2017 01 20 www ebionet com...

Страница 2: ...omplies with Consumer s protection law noticed by Economic Planning Dept Warranty period is 1 year Two years in Europe We will repair or replace any part of the FC1400 found to be defective in usual o...

Страница 3: ...elcomes your enquiries Please contact us In the event of a malfunction or failure contact Service Dept Of Bionet Co Ltd along with the model name serial number date of purchase and explanation of fail...

Страница 4: ...to any foreign material put into the product or improper cleaning or abuse Charged the first time 1 Product cleaning adjustments use instructions etc are not product troubles If the product cannot be...

Страница 5: ...ODUCT 20 4 COMPOSITION OF FC1400 22 5 SYSTEM INSTALLATION 25 CHAPTER 3 BASIC OPERATION 28 1 SYSTEM START 28 2 SYSTEM FINISHING 28 3 GRAPHIC SCREEN 28 4 OPERATION PANEL 29 5 MENU 30 6 POWER CONNECTION...

Страница 6: ...RM LED 59 5 AUDIBLE SILENCE AND PAUSE 59 6 ALARM LATCHING 60 7 ALARM HISTORY 60 8 PRESET 61 9 ALARM VOLUME ADJUSTMENT 62 10 SETTING ALL ALARMS ON OFF 63 11 SETTING ALL ALARMS RANGES 63 12 SETTING ALL...

Страница 7: ...ERATION 74 6 LATE DECELERATION 75 7 EARLY DECELERATION 76 8 VARIABLE DECELERATION 77 CHAPTER 17 MESSAGE LIST 78 CHAPTER 18 SIMPLE TROUBLESHOOTING 79 1 TROUBLESHOOTING AND SOLUTIONS 79 2 PERFORMING PER...

Страница 8: ...ent according to all the warnings and cautions Warning To inform that it may cause serious injury or death to the patient property damage material losses Caution To inform that it may cause no harm in...

Страница 9: ...10 C to 40 C Operating humidity ranges from 30 to 85 Avoidplacing in the vicinity of Electric heaters Avoid placing in an area where there is an excessive humidity rise or ventilation problem Avoid pl...

Страница 10: ...s should be disposed of separately from the municipal waste stream via designated collection facilities appointed by the government or the local authorities 3 The correct disposal of your old applianc...

Страница 11: ...switch Once monitoring is restored you should verify correct monitoring state and alarm function Maintenance Regular preventive maintenance should be carried out annually Technical inspections You ar...

Страница 12: ...sale by or on the order of a physician Supervised Use This equipment is intended for use under the direct supervision of a licensed health care practitioner Ventilation Requirements Set up the device...

Страница 13: ...urce with other electric instruments may cause incorrect results NOTE FC1400 is classified as listed below Do not use the equipment in the vicinity of flammable anesthetics and solvents The monitor is...

Страница 14: ...use during any electric operation defibrillation or defibrillator discharge Warning The equipment has not been designed for use with other types of monitoring equipment apart from those devices permit...

Страница 15: ...g chemical residue on the surface of the equipment After allowing sufficient time for the chemical to work wipe off all residues with a cloth damp with water Prevent any fluid from seeping into the mo...

Страница 16: ...the main body and the sensors Do not use the equipment if it has been damaged or if it has deteriorated Clean the exterior of the equipment at least once a month using soft cloth wet with tepid water...

Страница 17: ...nd performance of the monitor it is recommended that the calibration accuracy and electrical safety of the monitor be verified on an annual basis by a Bionet Service Representative Daily Testing It is...

Страница 18: ...EC 601 1 External Signal IN OUT Port IEC 60601 1 Type BF applied part Stand by External Signal Ethernet Port External Signal USB Port IEC 60601 1 Type CF applied part Equipotentiality Video Out IPX0 I...

Страница 19: ...tus FHR and fetal movements can be measured optional specification 3 Measured data can be saved and identified on the LCD Thus the condition of the fetus can be efficiently monitored during labor with...

Страница 20: ...e box and check if the following components are included in addition please check the main body and the components for any damage Basic composition and accessories Fetal system main body US probes 2 T...

Страница 21: ...C1400 Operation Manual Warning Do not reuse the ultrasonic gel Warning How to replace battery Please make sure you use the right battery as shown here Otherwise we are not liable for any damages and o...

Страница 22: ...ontrol panel Controls the functions Printer door Opens for replacing recording paper Warning To avoid high voltage electric shock please refrain from disassembling the equipment If any of the probes h...

Страница 23: ...lifting and moving the equipment Rear view Power adaptor connector Power adaptor of 18V 2 8 A is connected LAN Port Part for LAN communications with external equipment USB1 Port Part for USB1 communic...

Страница 24: ...ection terminal 1 Connection terminal to which the US probe is to be connected US probe connection terminal 2 Connection terminal to which the US probe is to be connected when measuring twin fetus TOC...

Страница 25: ...etc Installation of recording paper You can open printer cover by pushing Printer cover open lever to the right Load paper with printable side up and close the cover Put the adaptor into the connecti...

Страница 26: ...ions in use Installation and storage Please avoid moisture high temperature dust in the air salt and sulfuric materials including places that are not well ventilated and direct sunlight Please avoid v...

Страница 27: ...lease keep the main body and the measuring probe clean by wiping them off with soft cloth wet with alcohol at least once a month Do not use lacquer thinner ethylene or oxidizing substances Keep the ca...

Страница 28: ...6 seconds will trigger power off action 3 Graphic screen Monitoring screen Date and time Patient name or ID Bed ID Icon indicating the state of connection of the USB terminal Icon indicating the stat...

Страница 29: ...US1 volume down button Short key US1 Volume down or moving to earlier 6 Secs in trace mode Long key Mute US1 sound US2 volume down button Short key US2 Volume down or moving to later 6 Secs in trace...

Страница 30: ...ey A This is used to record data on the recording sheet in real time in the monitoring mode B This is also used to print data on the recording sheet at high speeds in the data view mode Long key Paper...

Страница 31: ...screen Color selection and entry To select the color of a line or a numerical value drag the cursor to the desired color and touch the selection key or color on the screen Line selection To select th...

Страница 32: ...n the power switch has been turned on if AC power is connected to the main body of the equipment the Power LED on the front side of the equipment will emit a green light In case a battery has been ins...

Страница 33: ...battery should be used Type SDI1865L240 3S2PMXZ Lithium Ion Rechargeable Battery Pack 11 1V 4800mV Time The battery will be automatically charged when the equipment is connected to AC power and the b...

Страница 34: ...n batteries Owing to the nature of lithium batteries themselves the batteries are self discharged The rate of self discharge is doubled every time the temperature is increased by 10 18 The loss of ele...

Страница 35: ...patients You can change elements such as alarm limits and so forth When you discharge the patient these elements return to their default values preset value Changes can be stored permanently in Confi...

Страница 36: ...t values Patients can be registered using the New function if they are measured for the first time If the records of the patients measured before are left in the Trace the Search function can be used...

Страница 37: ...position of patient information on top of the screen 2 Edit patient information This is a method of editing patients information Touch Patient in the menu Select Edit to edit a patient except ID infor...

Страница 38: ...nected the noise will increase In the running condition of the equipment turn on the Mute by long pressing volume down key when not measured long press volume up key to return back to the previous set...

Страница 39: ...rt of the fetus thus the heartbeat sounds of the fetus may be frequently missed Move the US probe little by little around its position to place the US probe in a position where the sounds from the hea...

Страница 40: ...is touched a volume adjusting window will be displayed Alarm range This indicates the alarm ranges of parameters Beat indication When FHRs are detected as beats the heart icon will blink FHR value Th...

Страница 41: ...d Volume window using the speaker icon in the US area Volume Off Volume Volume adjusting key of operation panel Alarm FHR alarms for US1 and US2 can be adjusted separately Please set up whether alarm...

Страница 42: ...time the value is not maintained for a certain time To set up an alarm delay please touch the Alarm Delay area in the FHR setting menu If this function is not to be used please select Off to use this...

Страница 43: ...g the uterine activity 1 UC measurement TOCO probe connection Please connect a TOCO probe to the TOCO connection terminal on the left side of the equipment TOCO Probe New Probe Basic operations follow...

Страница 44: ...ace that hardens first in the abdomen of the patient Put the fixing button protruding on top of the TOCO probe into the hole of the fixing belt to fix the TOCO probe At this time please adjust the deg...

Страница 45: ...aneously TOCO Zero value Displays the reference value that appears when Zeroing has been done TOCO Displays the degrees of uterine contraction 3 Setup If the TOCO area of the screen is touched the fol...

Страница 46: ...ement This is used to set up whether to output fetal movement related graphs to the screen or through the printer If the value is FMD FM or FMD the title of TOCO will be displayed as TOCO FM if Off TO...

Страница 47: ...and measurement by pressing a marker jack when the patient feels fetal movements Method using a marker jack This is a method of recording fetal movements by relying on maternal perception for the tim...

Страница 48: ...ler signals and display the information along with information on uterine contraction In addition if any of the obtained values is larger than the preset critical value of the size of fetal movements...

Страница 49: ...tion Manual Chapter 8 Stimulator When stimulator has been pressed simulator symbol will be displayed on the screen LCD display Warning A stimulator can be used such as the GE stimulator or GE compatib...

Страница 50: ...tly pressed Clinical mark will be entered and Clinical Mark will be displayed when Trace range and Real time is printed Clinical mark will be displayed in Orange triangle and same in Print When Clinic...

Страница 51: ...me Note will be printed Adding Note Note lists can be added and edited by Users having Administrator rights Touch Main menu system Edit Note and enter the Admin password and then set the user environm...

Страница 52: ...al heart rates Markers or note entries are displayed at the bottom grids FMD Automatically detected fetal movements are displayed TOCO values in the range of 0 99 Units ditto for graphs of fetal movem...

Страница 53: ...ouching the left or right of trace window If US1 volume up key is pressed the view will be moved to earlier 1 min if US2 volume up key is pressed the view will be moved to later 1 min If US1 volume do...

Страница 54: ...ng or function key on the operation panel Home and function key 3 Setting up trace modes Touch the menu in the Trace screen The Trace menu will then appear Print Print Trace data of a fixed duration I...

Страница 55: ...In the situation of patient change the data until before the change will be saved The following windows appear approximately 10 seconds after the end of the progress bar window disappears automatical...

Страница 56: ...in real time To print currently inputted data touch the print icon on the operation panel or Print Start in the menu If any printing is in progress a print icon will be displayed on the upper right si...

Страница 57: ...uch the main menu Printer Touch the item grid in the menu If the grid is on the grid line is printed on the paper 2 Trend printing To print trend data please move to the point from which you want to p...

Страница 58: ...arm sounds alarm messages will appear successively on the alarm condition window An arrow next to an alarm message means that there is more than one message If two or more alarms occur the alarm at th...

Страница 59: ...r Yellow LED Alarm occurred due to patient condition Medium Alarm Flickering once a second Low Alarm Stay on Green LED Alarm occurred due to Technical Alarm and stays on 5 Audible Silence and Pause Wh...

Страница 60: ...nue to ring until the user takes an appropriate action Once the user takes action and alarm situation is over both audible and visual alarm will disappear 7 Alarm history This is a function of making...

Страница 61: ...volume alarm function usage alarm range alarm level alarm delay time US1 Volume US2 Volume To proceed alarm preset function touch Main Menu Preset As an authorized person only can set the function ent...

Страница 62: ...vels of volume or may be muted Touch Main Menu Preset Alarm Volume Selected the desired volume on the popup window Check if the current alarm volume is displayed on the alarm icon on the screen Alarm...

Страница 63: ...n Off and set the condition by pressing in Alarm Parameter window Default Value FHR1 On FHR2 On 11 Setting all alarms ranges This function allows users to select alarm ranges for each parameter Touch...

Страница 64: ...ult then select OK button Default Value FHR1 Medium FHR2 Medium 13 Default Setting This function is used when setting values in Alarm Parameter Alarm Limit and Alarm Level sections to their default va...

Страница 65: ...ireless setting If you use the Wireless LAN wireless LAN module is inserted into the USB slot on the rear side and the touch the Wireless menu and the touch the central menu When On the wireless LAN f...

Страница 66: ...Warning First check the Wireless LAN module equipment to make sure that it is properly seated before Central of state and Wireless change On Wireless is not set to On in unrecognized status Changing t...

Страница 67: ...stem in the main menu to define the general settings The following is the setting menu 1 Date changing To set up a date touch the Date in the setting menu 2 Time changing To set up a time touch the Ti...

Страница 68: ...alog board version 5 Changing the Touch volume To change the volume of touch sound please touch the Touch Tone in the setting menu The volume can be selected from Off and 1 5 6 Demo operation To opera...

Страница 69: ...Warning Admin password cannot be recovered after change If password is lost reset to Factory mode is the only way and all the measured data and set values will be lost Please keep the password safe 11...

Страница 70: ...passed alarms will sound to inform the user that the NST measurement has been finished To silence NST ending alarm Touch Alarm silence button on control panel Stopping NST If Print key is touched the...

Страница 71: ...Main Menu Printer Touch CTG Print and when screen change as CTG Print Off it is NOT printed out CTG result 2 CTG Output Start CTG When you start real time printing you can find remarked CTG interim re...

Страница 72: ...FC1400 User Manual FC1400OM 2 04 72 95 FC1400 Operation Manual 3 CTG Measurement results After measuring CTG the result will be printed out as below Middle Report Final Report...

Страница 73: ...surement High Episode Low Episode In case of under 30msec of changing width in 5 minutes is Low Episode and in case of over 32msec of changing width in 5 minutes is High Episode Short Term Variability...

Страница 74: ...OM 2 04 74 95 FC1400 Operation Manual 5 ACCELERATION Visually apparent abrupt increase onset to peak is 30sec of FHR above baseline Peak is 15 bpm Duration is 15 bpm and 2 min Peak of 10 bpm and durat...

Страница 75: ...decrease onset to nadir is 30 sec of FHR below baseline Return to baseline associated with a uterine contraction Nadir of deceleration occurs after the peak of the contraction Generally the onset nad...

Страница 76: ...se 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 on...

Страница 77: ...User Manual FC1400OM 2 04 77 95 FC1400 Operation Manual 8 Variable DECELERATION Visually apparent abrupt decrease onset to nadir is 30sec in FHR below baseline Decrease is 15 bpm Duration is 2 min and...

Страница 78: ...400OM 2 04 78 95 FC1400 Operation Manual Chapter 17 Message list 1 Patient Alarm Short Msg Figure Msg From FHR MEDIUM FHR xxx yyy FHR FHR LOW FHR xxx yyy FHR 2 INOP Alarm Short Msg Figure Msg No Paper...

Страница 79: ...er off sign will be displayed on the LCD screen In this case please open the printer check if the recording sheets have run out replenish the record sheets and close the printer to solve the problem W...

Страница 80: ...ucer Type 7 crystal Ultrasound frequency 1 0MHz Pulse Repetition Frequency 3125Hz Spatial Peak Temporal Average Intensity 10mW cm2 Uterine Contraction Input Source External Transducer Reference Contro...

Страница 81: ...the analysis of the signals thus detecting the heart rates and fetal movements of the fetus In addition it detects the degrees of uterine contraction of the patient using a pressure sensor It indicate...

Страница 82: ...nment Surge IEC 61000 4 5 1 kV differential mode 2 kV common mode 1 kV differential mod e 2 kV common mode Mains power quality should be that of a typical commerci al or hospital environment Power fre...

Страница 83: ...er Recommended separation distance Radiated RF IEC 61000 4 3 3 V m 80 0 MHz to 2 5 GHz 3 V m 80 0 MHz to 2 5 G Hz Recommended separation distance Where P is the maximum output power rat ing of the tra...

Страница 84: ...minimum distance between portable and mobile RF communications equipment transmitters and the FC1400 system as recommended below according to the maximum output power of the communications equipment R...

Страница 85: ...less than 3V m a Interference may occur in the vicinity of equipment marked with the following symbol Note 1 These guidelines may not apply in all situations Electromagnetic propagation is affected by...

Страница 86: ...e conditions during parturitions 5 Manufacturing number manufacturing date and weight 1 Manufacturing number To be written at the back of the main body when selling the product after obtaining item pe...

Страница 87: ...th markings and do not apply excessive force when inserting or manipulating intercavitary probes Inspect probes for sharp edges or rough surfaces that could injure sensitive tissue DO NOT apply excess...

Страница 88: ...a supply mains with ground Do not modify this equipment without authorization of the manufacturer If this equipment is modified appropriate inspection and testing must be conducted to ensure continue...

Страница 89: ...cument 2163920 100 AIUM 14750 Sweitzer Lane Suite 100 Laurel MD USA 20707 5906 telephone 1 800 638 5352 In accordance with US FDA Guidelines the overall maximum acoustic SPTA intensity for the product...

Страница 90: ...ral Average Intensity Izpta z ISPTA 3 Z Attenuated Spatial Peak Temporal Average Intensity MI MI Mechanical Index P Wo Output Power Time average acoustic power at the source P W 3 Z Attenuated Output...

Страница 91: ...7 P Wo mW 0 4 0 4 0 4 min of P zs Ita zs min of W 3 Z1 ITA 3 z1 mW zs z1 cm zbp zbp cm zb zsp cm 1 8 1 8 z at max Ipi zsp cm deq zb deq zsp cm 1 0865 awf fc MHz 0 999572 0 999572 0 999572 0 999572 Dim...

Страница 92: ...C Celsius cm CM centimeter D DC direct current E EMC electromagnetic compatibility EMI electromagnetic interference F F Fahrenheit G g gram H HR heart rate hour Hz hertz I Inc incorporated J K kg KG...

Страница 93: ...C1400OM 2 04 93 95 FC1400 Operation Manual Q R S sec second T Temp TEMP temperature U V V volt W X X multiplier when used with a number 2X Z Symbols and degree s greater than less than minus number pe...

Страница 94: ...Date of purchase MM DD YY Customer column Hospital name Address Name Phone Seller name Manufacturer name This product is medical equipment Thank you for buying FC1400 This product has passed thorough...

Страница 95: ...t com U S A sales service representative Bionet America Inc 2691 Dow Ave Suite B Tustin CA 92780 U S A Toll Free 1 877 924 6638 Fax 1 714 734 1761 e mail support bionetus com Website www bionetUS com...

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