EDAN F6 User Manual
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EDAN F6 User Manual

F series festal & material monitor
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  • Page 2: About This Manual

    This manual will help you understand the operation and maintenance of the product better. It is reminded that the product shall be used strictly complying with this manual. User’s operation failing to comply with this manual may result in malfunction or accident for which EDAN INSTRUMENTS, INC. (hereinafter called EDAN) can not be held liable.
  • Page 3 EDAN may define as user serviceable. Terms Used in this Manual This guide is designed to give key concepts on safety precautions. WARNING A WARNING label advises against certain actions or situations that could result in personal injury or death.

  • Page 4: Table Of Contents

    Table of Contents Chapter 1 Safety Guide ················································································································ 1 1.1 Intended Use........................1 1.2 Features ..........................2 1.3 Instruction for Safe Operation .................... 2 1.4 Ultrasound Safety Guide ....................3 1.5 Safety Precautions ......................4 1.6 Definitions and Symbols ....................11 Chapter 2 Installation Guide ······································································································...
  • Page 5 4.1 Alarms Classification ....................... 33 4.2 Audible Alarm ........................33 4.3 Visual Alarm ........................34 4.4 Choosing the Alarm Display Form .................. 35 4.5 Changing the Alarm Volume ................... 35 4.6 *Choosing Alarm Silence Duration ................. 35 4.7 Choosing Signal Loss Delay .................... 35 4.8 Pausing or Resetting the Alarm ..................
  • Page 6 7.2.4 Changing FHR Alarm Limits ................. 56 7.2.5 Changing FHR Alarm Delay .................. 56 7.2.6 Testing US Transducers ..................57 7.3 Monitoring FHR with DECG ................... 58 7.3.1 Contraindications ....................58 7.3.2 Parts Required ......................58 7.3.3 Preparing Patient's Skin Prior to Placing Electrodes ..........58 7.3.4 Changing DECG Beep Volume ................
  • Page 7 8.4 Fetal Monitoring Alarm Messages ................... 83 8.4.1 Patient Alarm Messages ..................83 8.4.2 Technical Alarm Messages ..................83 Chapter 9 Maternal Monitoring (F6 Express/F9 Express) ····················································· 85 9.1 Maternal ECG Monitoring ....................85 9.1.1 Introduction ......................85 9.1.2 How to Place 3-lead ECG Cables ................86 9.1.3 ECG Monitoring Procedure ...................
  • Page 8 9.5.2 Changing TEMP Unit ..................104 9.5.3 Switching the TEMP Alarm On or Off ..............104 9.5.4 Changing TEMP Alarm Limits ................104 Chapter 10 Maternal Monitoring Display (F6 Express/F9 Express)···································· 105 10.1 *Display Mode ......................105 10.2 Maternal Monitoring Traces ..................107 10.3 Maternal Vital Sign List ....................
  • Page 9 11.1.3 Features ......................117 11.2 Installation Guide ......................118 11.2.1 Opening the Package and Checking ..............118 11.2.2 Installing Battery ....................118 11.2.3 Installing the System ..................120 11.2.4 Connecting Power Cable ..................121 11.2.5 Connect to the Base Station ................122 11.2.6 Configure the Monitor ..................
  • Page 10 14.1 Warranty ........................137 14.2 Contact information ..................... 137 Appendix 1 Product Specifications ·························································································· 138 A1.1 Environmental Specifications ..................138 A1.2 Physical Specifications ....................138 A1.3 Performance Specifications ..................140 A1.4 Recorder Specifications ....................144 A1.5 Rechargeable Lithium-ion Battery ................145 A1.6 Low Output Summary Table ..................
  • Page 11 A4.3.3 Measurement Uncertainty ................. 162 A4.4 Prudent Use Statement ....................163 A4.5 References for Acoustic Output and Safety ..............163 A4.6 Probe Acoustic Output Parameters List ..............164 A4.6.1 Test of Wired Probe ..................164 A4.6.2 Test of Wireless Probe (FTS-3) ................ 168 Appendix 5 Abbreviation ··········································································································...

  • Page 12: Chapter 1 Safety Guide

    Indications for Use/ Intended Use F6/F9 Fetal & Maternal Monitor (hereinafter called F6/F9): F6/F9 Fetal & Maternal Monitor is intended for non-invasive and invasive monitoring of fetus during antepartum examination, labor and delivery. It is intended to be used only by trained and qualified personnel in antepartum examination rooms, labor and delivery rooms.

  • Page 13: Features

    1.3 Instruction for Safe Operation NOTE: In this manual, Monitor refers to F6, F6 Express, F9 and F9 Express, and is used where the information applies to all models. ‹ The monitor is designed to comply with the international safety requirements IEC/EN 60601-1 for medical electrical equipment.

  • Page 14: Ultrasound Safety Guide

    F Series Fetal & Maternal Monitor User Manual Safety Guide does not accept responsibility for safety compliance, reliability and performance if modifications or repairs are carried out by unauthorized personnel. Identical replacement parts must be used. ‹ The protective degree against electric shock of the patient connections is: Ultrasound (FHR1, FHR2) External TOCO Type BF...

  • Page 15: Safety Precautions

    F Series Fetal & Maternal Monitor User Manual Safety Guide 1.5 Safety Precautions WARNING and CAUTION messages must be observed. To avoid the possibility of injury, observe the following precautions during the operation of the instrument. WARNING For using safety: The monitor or FTS-3 telemetry system (hereinafter called FTS-3) is provided for the...
  • Page 16 F Series Fetal & Maternal Monitor User Manual Safety Guide WARNING 11 SHOCK HAZARD – Do not connect non-medical electrical equipment, which has been supplied as a part of the system, directly to the wall outlet when the non-medical equipment is intended to be supplied by a multiple portable socket-outlet with an isolation transformer.
  • Page 17 F Series Fetal & Maternal Monitor User Manual Safety Guide WARNING 24 Make sure that the power is turned off and the power cord is disconnected from the AC socket before connecting or disconnecting equipment. Otherwise, the patient or operator may receive electrical shock or other injury. 25 Disconnect power cord before changing fuses.
  • Page 18 F Series Fetal & Maternal Monitor User Manual Safety Guide WARNING 38 Use the battery only in F6 / F6 Express / F9 / F9 Express. 39 Do not reverse the battery pole or it will cause explosion. 40 Do not unplug the battery when monitoring.
  • Page 19 The battery in the wireless transducer should be replaced by the serviceman authorized by EDAN. The wireless transducer has priority over the wired transducer. When the wireless transducer is working, the wired transducer will be turned off automatically. Do not use the wireless transducer and the wired transducer at the same time.
  • Page 20 F Series Fetal & Maternal Monitor User Manual Safety Guide CAUTION Electromagnetic Interference - Ensure that the environment in which the monitor or FTS-3 is installed is not subject to any source of strong electromagnetic interference, such as CT, radio transmitters, mobile phone base stations, etc. Even though other devices are in accordance with national standard radiation requirements, the monitor or FTS-3...
  • Page 21 F Series Fetal & Maternal Monitor User Manual Safety Guide CAUTION 21 The device and accessories are to be disposed of according to local regulations after their useful lives. Alternatively, they can be returned to the dealer or the manufacturer for recycling or proper disposal. Batteries are hazardous waste. Do NOT dispose them together with house-hold garbage.

  • Page 22: Definitions And Symbols

    F Series Fetal & Maternal Monitor User Manual Safety Guide CAUTION 12 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. 13 Any Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment.
  • Page 23 F Series Fetal & Maternal Monitor User Manual Safety Guide Socket for TEMP Sensor (Type CF applied part) RS232 Interface (DB9 or D-Sub) RJ45 Interface Equipotential Grounding Battery check Alternating Current (a.c.) Stand-by Caution, consult ACCOMPANYING DOCUMENTS Warning Operating instructions Follow instructions for use Type BF applied part Defibrillation-proof type BF applied part...
  • Page 24 F Series Fetal & Maternal Monitor User Manual Safety Guide CE marking Disposal method Part Number Serial Number Date Of Manufacture Manufacturer Authorized Representative in the European Community General symbol for recovery/recyclable Caution: Federal (U.S.) Law restricts this device to sale by or on the order of a physician With respect to electrical shock, fire and mechanical hazards only in accordance with UL 60601-1and CAN/CSA C22.2 No.
  • Page 25 F Series Fetal & Maternal Monitor User Manual Safety Guide Ethernet Port (Reserved) Channel Adjustment - 14 -...

  • Page 26: Chapter 2 Installation Guide

    F9, F9 Express Fetal & Maternal Monitor User Manual Installation Guide Chapter 2 Installation Guide NOTE: Installation must be carried out by qualified personnel authorized by the manufacturer. 2.1 Opening and Checking Package Visually examine the package prior to unpacking. If any signs of mishandling or damage are detected, contact the carrier to claim for damage.
  • Page 27 F9, F9 Express Fetal & Maternal Monitor User Manual Installation Guide Take the battery out from package. Put the battery and the cables into the battery compartment and insert the cable connector into the socket. 4) Shut the battery compartment cover and fix the screws. (2) Battery Removal Fold the LCD display completely flat before turning the monitor upside down.

  • Page 28: Installing Monitor

    F Series Fetal & Maternal Monitor User Manual Installation Guide NOTE: 1 If a rechargeable battery is outfitted, charge it fully each time after using the device to ensure the electric power is enough. 2 After the device is transported or stored for a long time, charge the battery fully before use.

  • Page 29: Chapter 3 Monitor And Accessories

    Chapter 3 Monitor and Accessories 3.1 Overview NOTE: F6/F6 Express differs from F9/F9 Express in LCD size. This manual takes pictures and interfaces of F9/F9 Express as an example, and they may look slightly different from your model. 1 Keys...

  • Page 30: Keys And Control Knob

    F Series Fetal & Maternal Monitor User Manual Monitor and Accessories 16 POWER Switch Figure 3-3 Right Panel 17 Equipotential Grounding Terminal 18 Antenna (Not applicable) 19 USB Socket (Not applicable) 20 Power Socket 21 Handle 22 DB9 Socket Figure 3-4 Rear Panel 23 RJ45Socket 24 Fuses 25 Battery Compartment...
  • Page 31 F Series Fetal & Maternal Monitor User Manual Monitor and Accessories The Monitor is a user-friendly device with operation conducted by a few keys on the front panel and the control knob. Their functions are as follows: START Function: Start monitoring or return to the main interface Press this key to start monitoring (on the main interface) or return to main interface (in maternal information inputting menu or setup menus).

  • Page 32: Indicators

    F Series Fetal & Maternal Monitor User Manual Monitor and Accessories This function is only available on F6 Express and F9 Express. (8) CONTROL KNOB Function: Adjust volume, setup and review control. It can be pressed like other keys and be rotated clockwise or counterclockwise. All the operations on the screen or in the menu are completed by using the control knob.

  • Page 33: Accessories

    F Series Fetal & Maternal Monitor User Manual Monitor and Accessories Indicator Status of Indicator Meaning Flash or light up in yellow An alarm is active. Alarm Indicator No alarm is active. The battery is being charged. Charge No battery or the battery is fully Indicator charged.

  • Page 34: Belt

    F Series Fetal & Maternal Monitor User Manual Monitor and Accessories 3.2.3 Belt Figure 3-9 Belt 3.2.4 Remote Event Marker 1 Marker Plug 2 Press Key Figure 3-10 Remote Event Marker 3.2.5 DECG Cable 1 DECG Cable Plug 2 DECG Cable Connector Figure 3-11 DECG Cable - 23 -...

  • Page 35: Fetal Spiral Electrode

    F Series Fetal & Maternal Monitor User Manual Monitor and Accessories 3.2.6 Fetal Spiral Electrode Figure 3-12 Fetal Spiral Electrode Reference Electrode Drive Tube Guide Tube Drive Handle Handle Notch Electrode Wire Safety Cap 3.2.7 IUP Cable Figure 3-13 IUP Connecting Cable Figure 3-14 IUP Cable Interface to IUP Cable Connecting plug...

  • Page 36: Iup Catheter

    F Series Fetal & Maternal Monitor User Manual Monitor and Accessories 3.2.8 IUP Catheter 1 Interface to IUP Cable 2 Catheter Figure 3-15 IUP Catheter 3.2.9 ECG Cable 1 ECG Connector 2 ECG Fastener 3 Lead Wire Figure 3-16 3-Lead ECG Cable 3.2.10 SpO Sensor 1 SpO...

  • Page 37: Nibp Cuff

    F Series Fetal & Maternal Monitor User Manual Monitor and Accessories 3.2.11 NIBP Cuff 1 NIBP Cuff 2 Cuff Extension Tube Figure 3-18 NIBP Cuff Figure 3-19 Cuff Extension Tube 3.2.12 TEMP Sensor 1 TEMP Sensor 2 TEMP Connector Figure 3-20 TEMP Sensor - 26 -...

  • Page 38: Screen

    F Series Fetal & Maternal Monitor User Manual Monitor and Accessories 3.3 Screen 3.3.1 Main Interface Message Window Trace/Menu Window Numeric Window Status Window Figure 3-21 Main Interface Background Color Switch The main interface of the monitor displays numbers, traces, menus and monitor status information.
  • Page 39 : Paper advancing key. Select this key to advance the paper for 8 cm (PHILIPS paper) or 7 cm (GE paper). : Display mode switch. F6 Express and F9 Express monitors have three display modes: maternal-fetal display mode, fetal display mode and maternal display mode. Select this key, and the display mode will switch to the next one in order.
  • Page 40 F Series Fetal & Maternal Monitor User Manual Monitor and Accessories Status Window f) Power indicator - AC power supplied. - no AC power supplied. g) Battery indicator The battery is loaded into the monitor with 100% capacity 75% capacity 50% capacity 25% capacity The battery is almost depleted and needs to recharge immediately.

  • Page 41: Setup Interface

    F Series Fetal & Maternal Monitor User Manual Monitor and Accessories - the current audible alarm is switched off infinitely. - the current audible alarm is switched off temporarily. j) Recorder status indicator - the recorder is in the process of printing. - no printing is going on.

  • Page 42: Touch Screen

    F Series Fetal & Maternal Monitor User Manual Monitor and Accessories Setup Items Software Version Function description Figure 3-22 Main Setup Menu (F9 Express) In the setup main menu, you have access to all the items other than System. You can select EXIT to exit from this menu.
  • Page 43 F Series Fetal & Maternal Monitor User Manual Monitor and Accessories the control knob to this item and then pressing it. In the same way, one of the three results with the control knob will be achieved. On the main interface, the symbols might appear right next to the highlighted item.

  • Page 44: Chapter 4 Alarms

    F Series Fetal & Maternal Monitor User Manual Alarms Chapter 4 Alarms 4.1 Alarms Classification The monitor has two types of alarm: patient alarm and technical alarm. Patient alarms indicate the situation of vital sign exceeding its configured limit. Audible alarms and visual alarms can be disabled excluding ASYSTOLE alarm.

  • Page 45: Visual Alarm

    F Series Fetal & Maternal Monitor User Manual Alarms WARNING Do not rely exclusively on the audible alarm system for patient monitoring. Adjustment of alarm volume to a low level or off during patient monitoring may result in patient danger. Remember that the most reliable method of patient monitoring combines close personal surveillance with correct operation of monitoring equipment.

  • Page 46: Choosing The Alarm Display Form

    F Series Fetal & Maternal Monitor User Manual Alarms 4.4 Choosing the Alarm Display Form You can change the patient alarm display form, 1 Select the setup key on the main interface. 2 Select Alarm. On the displayed Password box, enter 9999, then select Enter. 3 Select Message Form.

  • Page 47: Pausing Or Resetting The Alarm

    F Series Fetal & Maternal Monitor User Manual Alarms 1 Select the setup key on the main interface. 2 Select Alarm. On the displayed Password box, enter 9999, then select Enter. 3 Select Signal Loss Delay. 4 Select 0 (default) ~ 300 seconds. 5 Select OK.

  • Page 48: Alarm Treatment Measures

    F Series Fetal & Maternal Monitor User Manual Alarms Each page displays 10 alarm records. The page mark “1/6” informs you that there are 6 pages and the present one is page 1. To review more records, select the alarm list and then rotate the control knob to switch to the previous or next page.

  • Page 49: Testing Alarms

    F Series Fetal & Maternal Monitor User Manual Alarms 4.11 Testing Alarms To test the functions of visible and audible alarms, do the following: 1 Switch on the monitor. 2 Enable the alarm. 3 Set the alarm limits to a small range. 4 Stimulate a signal that is higher than the upper limit or lower than the lower limit.
  • Page 50 F Series Fetal & Maternal Monitor User Manual Alarms Alarm Delay 0 second, not adjustable 0 second Alarm Level Medium, not adjustable Medium SYS Alarm On, Off SYS Low Alarm Limit 40 mmHg ~ 269 mmHg, in increments of 1 90 mmHg SYS High Alarm Limit 41 mmHg ~ 270 mmHg, in increments of 1...

  • Page 51: Chapter 5 Printing

    F Series Fetal & Maternal Monitor User Manual Printing Chapter 5 Printing 5.1 *Function Description The built-in thermal recorder applied in the monitor supports both the American and international standard wide recorder paper. It prints continuous traces synchronously along with marks. The monitor supports some other functions listed below: ‹...

  • Page 52: Printing Configuration

    F Series Fetal & Maternal Monitor User Manual Printing 5.2 Printing Configuration NOTE: All the parameters should be well configured before printing starts. You can not change the configuration in the process of printing. 5.2.1 Switching Auto Start Printing On or Off You can switch auto start printing on or off: 1 Select the setup key on the main interface.

  • Page 53: Switching Print Self-Check On Or Off

    F Series Fetal & Maternal Monitor User Manual Printing 5.2.4 Switching Print Self-Check On or Off You can switch on or off the print self-check feature: 1 Select the setup key on the main interface. 2 Select Recorder > Print Self-Check. 3 Select ON or OFF (default).
  • Page 54 F Series Fetal & Maternal Monitor User Manual Printing (13) (14) (11) (10) (12) Figure 5-1 An example of recorder paper with traces Item Information Description The monitor prints a self-check trace after being switched on. It is Self-Check Trace used to check if the recorder paper is properly loaded.
  • Page 55 F Series Fetal & Maternal Monitor User Manual Printing Mark The trace marked with “SpO ” is the maternal SpO trace. In the real-time printing mode, each NIBP measurement result is NIBP printed on the paper in the order of SYS/DIA. Each recorder paper pack has 150 pages.

  • Page 56: Chapter 6 Pre-Monitoring Preparation

    F Series Fetal & Maternal Monitor User Manual Pre-Monitoring Preparation Chapter 6 Pre-Monitoring Preparation 6.1 Loading Recorder paper CAUTION 1 Only use the recorder paper provided by the manufacturer, otherwise the recorder may be damaged. This kind of damage is not covered by warranty. 2 Configured with different hardware, the monitor is compatible with both GE and Philips recorder paper.
  • Page 57 F Series Fetal & Maternal Monitor User Manual Pre-Monitoring Preparation 4) Unfold two sheets from the top of the pack and pull the end of the paper out of the drawer (make sure the pack in the drawer remains flat). 5) Slide the drawer in until both the latches are locked.

  • Page 58: Switching On

    F Series Fetal & Maternal Monitor User Manual Pre-Monitoring Preparation 6.2 Switching On WARNING 1 Check if all the metal parts are linked to the protective earth cord and the cord is in good condition before switching on the monitor. 2 If any sign of damage is detected, or the monitor displays some error messages, do not use it on any patient.

  • Page 59: Adjusting Screen Angle

    F Series Fetal & Maternal Monitor User Manual Pre-Monitoring Preparation If the monitor does not print the baseline, switch on the Print Self-Check function and then restart the monitor. NOTE: Make sure the paper is correctly loaded before the printing starts. 6.4 Adjusting Screen Angle The angle between the screen and the top cover of the monitor is adjustable as needed, allowing it to be mounted on a wall or placed on a flat surface.

  • Page 60: Setting Date And Time

    F Series Fetal & Maternal Monitor User Manual Pre-Monitoring Preparation 6.5 Setting Date and Time You can change the date and time of the monitor, 1 Select the setup key on the main interface. 2 Select Date And Time. 3 Set the year, month, date, hour, minute and second. The first three numbers are used to set the year, month and date.

  • Page 61: Placing Accessories In The Holder

    F Series Fetal & Maternal Monitor User Manual Pre-Monitoring Preparation When plugging transducers into the monitor, make sure the arrow symbol of the connector faces up and put it into the socket. When disconnecting a transducer, pinch the afterbody of the transducer plug and pull it out slightly.

  • Page 62: Adjusting The Volume

    F Series Fetal & Maternal Monitor User Manual Pre-Monitoring Preparation NOTE: In the process of monitoring, the transducer that is placed in the holder may be affected and thereby produces interfering signals. Therefore, when monitoring a patient, it is recommended to remove or disconnect the transducer that is not in use. 6.8 Adjusting the Volume The monitor automatically detects which channel the transducer is connected to.
  • Page 63 F Series Fetal & Maternal Monitor User Manual Pre-Monitoring Preparation *Adjust the key volume: The volumes of pressing keys, rotating and pressing the control knob are also adjustable. 1 Select the setup key on the main interface. 2 Select General > Key Volume. 3 Select Low (default), High or OFF.

  • Page 64: Chapter 7 Fetal Monitoring

    F Series Fetal & Maternal Monitor User Manual Fetal Monitoring Chapter 7 Fetal Monitoring WARNING 1 The monitor is not intended for use in intensive care units (ICU), operating rooms or for home use. 2 Do not apply the monitor during electro-surgery or MRI; otherwise it might result in harming the patient or the operator.

  • Page 65: Fhr Monitoring Procedure

    F Series Fetal & Maternal Monitor User Manual Fetal Monitoring 7.2.2 FHR Monitoring Procedure 1) Placing Transducer Belt Place the transducer belts across the bed, ensuring that the belt will be around the abdomen when it is fastened. Lay the patient on the bed. Alternatively, the patient can take a sitting position.

  • Page 66: Switching Fhr Alarm On Or Off

    F Series Fetal & Maternal Monitor User Manual Fetal Monitoring Make sure the belt fits the patient snugly but comfortably. Meanwhile, fetus heart beat sound is heard; the FHR trace and numeric are displayed. During long-time monitoring, the gel may dry out as the transducer moves around.

  • Page 67: Changing Fhr Alarm Limits

    F Series Fetal & Maternal Monitor User Manual Fetal Monitoring 3 Select FHR. 4 Select ON (default) or OFF for Alarm. 5 Select OK. When the alarm is switched off, an alarm switched-off symbol appears in the numeric window. For example: WARNING Do not switch the alarm off for the condition where the patient’s safety maybe endangered.

  • Page 68: Testing Us Transducers

    F Series Fetal & Maternal Monitor User Manual Fetal Monitoring 4 Select a value from 0 ~ 30 second(s) for Alarm Delay. (The step is 5, and the default value is 10 seconds.) 5 Select OK. WARNING The FHR alarm delay is adjustable between 0 and 30 seconds. 7.2.6 Testing US Transducers To test a US transducer: 1) Switch on the monitor.

  • Page 69: Monitoring Fhr With Decg

    F Series Fetal & Maternal Monitor User Manual Fetal Monitoring 7.3 Monitoring FHR with DECG 7.3.1 Contraindications The fetal spiral electrode can be used when amniotic membranes are adequately ruptured and sufficient cervical dilatation is ensured. The fetal electrode tip is designed to penetrate the epidermis of the fetus;...

  • Page 70: Changing Decg Beep Volume

    F Series Fetal & Maternal Monitor User Manual Fetal Monitoring 4) Remove skin scurf and grease. 7.3.4 Changing DECG Beep Volume When the DECG beep is enabled, the monitor gives a beep sound of DECG. To change the DECG beep volume, 1 Select the setup key on the main interface.

  • Page 71: Directions For Using Fetal Spiral Electrode

    F Series Fetal & Maternal Monitor User Manual Fetal Monitoring 7.3.6 Directions for Using Fetal Spiral Electrode 1 With the patient in the dorsal lithotomy position, perform a vaginal examination and clearly identify the fetal presenting part. 2 Remove the spiral electrode from the package; leave the electrode wires locked in the handle notch.

  • Page 72: Detaching Fetal Spiral Electrode

    F Series Fetal & Maternal Monitor User Manual Fetal Monitoring 5 Remove the film on the back of the electrode and place the electrode on maternal thigh; press it firmly in place. 6 Connect the fetal spiral electrode to the DECG cable. 7 Insert connector of DECG cable into the DECG socket of the monitor.

  • Page 73: Monitoring Internally

    F Series Fetal & Maternal Monitor User Manual Fetal Monitoring 7.4.2 Monitoring Internally Alternatively, you can monitor a FH using ultrasound externally, and monitor the second FH using DECG internally. Connect the US transducer to US2 socket; connect DECG cable to DECG socket. Monitor one twin with a US transducer using the procedures described in Section 7.2 Monitoring FHR with Ultrasound.

  • Page 74: Monitoring Uterine Activity Externally

    F Series Fetal & Maternal Monitor User Manual Fetal Monitoring “FHR2: -20bpm”: the FHR2 trace is 20bpm lower than it really is. “FHR2: 0bpm”: the FHR2 trace is in its real position. “FHR2: 20bpm”: the FHR2 trace is 20bpm higher than it really is. 7.5 Monitoring Uterine Activity Externally 7.5.1 Parts Required 1) TOCO transducer...

  • Page 75: Changing Ua Baseline

    F Series Fetal & Maternal Monitor User Manual Fetal Monitoring 3) *Adjusting the Numeric to Zero Press the AUTO ZERO key to adjust the numeric to the baseline. Make sure this is not done during a contraction. The uterine activity reading at this point should be 30 ~ 90. A flat-top aligned with 100 on the TOCO scale indicates the belt is too tight, and you need to adjust it.

  • Page 76: Monitoring Uterine Activity Internally

    F Series Fetal & Maternal Monitor User Manual Fetal Monitoring Figure 7-6 Testing a TOCO Transducer 4) Check that the value on the display shows this change in pressure. If a TOCO transducer fails the test, repeat this test with another transducer. If the second one passes the test, defect of the first transducer is confirmed.
  • Page 77 F Series Fetal & Maternal Monitor User Manual Fetal Monitoring Insertion NOTE: This product is designed for use with the introducer. Using aseptic technique, remove the catheter from the package. Perform vaginal exam to ensure ruptured membranes and adequate dilation. Advance the catheter tip to the cervical os along the examination hand, using the hand as a guide.
  • Page 78 F Series Fetal & Maternal Monitor User Manual Fetal Monitoring Figure 7-10 Secure the adhesive pad to mother Rezeroing the System During Monitoring 1) With the catheter connected to the IUP cable, momentarily pressing the re-zero button on the pressure cable. The green light on the cable will flash for five seconds. Figure 7-11 Rezeroing the system 2) During this period, adjust the monitor to zero by pressing AUTO ZERO key.

  • Page 79: Iup Monitoring Procedure

    F Series Fetal & Maternal Monitor User Manual Fetal Monitoring 7.6.3 IUP Monitoring Procedure 1) Insert IUPC using the procedure described in section 7.6.2 Directions for Use of IUPC. 2) Connect the IUPC to the IUP cable. Figure 7-12 Connect catheter to pressure cable 3) Connect the IUP cable to the connecting cable.

  • Page 80: Monitoring Fetal Movement

    F Series Fetal & Maternal Monitor User Manual Fetal Monitoring 7.7 Monitoring Fetal Movement 7.7.1 Auto Fetal Movement (AFM) Monitoring During fetal heart monitoring with ultrasound, the fetal movement signals are also detected. The fetal movement signals differ from the Doppler heart rate signals in that they have larger extent and lower frequency.

  • Page 81: Choosing Afm Mode

    F Series Fetal & Maternal Monitor User Manual Fetal Monitoring 7.7.4 Choosing AFM Mode When AFM monitoring is enabled, the AFM monitoring result is displayed either in the form of a trace or black marks. To choose AFM mode, 1 Select the setup key on the main interface.

  • Page 82: Start Monitoring

    F Series Fetal & Maternal Monitor User Manual Fetal Monitoring 7.8 *Start Monitoring After the START key is pressed, the monitor automatically zeroes the pressure, clears the MFM count and starts monitoring. If the Auto Printing is disabled, press the PRINT key to start printing. 7.9 *Inputting Maternal Information (Mat.

  • Page 83: Switching Mat. Info Inputting On Or Off

    F Series Fetal & Maternal Monitor User Manual Fetal Monitoring The monitoring does not stop when you change maternal information. After you select OK to exit, the new ID takes the place of the old one for this patient. NOTE: 1 Pressing the START key separates two patients.

  • Page 84: Chapter 8 Fetal Monitoring Display (F6/F9)

    F Series Fetal & Maternal Monitor User Manual Fetal Monitoring Display Chapter 8 Fetal Monitoring Display (F6/F9) 8.1 Traces WARNING Due to the LCD size, resolution and system settings, the traces displayed on the screen may look different from the recorder printout. The printout should prevail when making diagnoses.

  • Page 85: Changing Time Scale

    F Series Fetal & Maternal Monitor User Manual Fetal Monitoring Display TOCO trace The y-axis indicates the numeric of TOCO. The range is 0% ~ 100%. If FHR is monitored using DECG, and the DECG trace is switched on in the hardware setup (only service engineers have access to it), a DECG trace is shown underneath other traces on the screen.

  • Page 86: Trace Control Tools

    F Series Fetal & Maternal Monitor User Manual Fetal Monitoring Display 8.2 Trace Control Tools Figure 8-2 Trace Control Tools Searching Key Reviewing Keys Alarm Reviewing Key CTG Analyzing Key 8.2.1 Data Saving When the START key is pressed, the monitor saves data of the previous ID in a file, and then clears it from the main interface.

  • Page 87: Reviewing

    F Series Fetal & Maternal Monitor User Manual Fetal Monitoring Display If the required file is not in this list, 2 Select MORE to open the Patient Searching window. Figure 8-4 Patient Searching 3 Select ID, input the patient ID with the soft keyboard and select Enter. 4 Select Name, input the patient’s name with the soft keyboard and select Enter.

  • Page 88: Ctg Analysis

    F Series Fetal & Maternal Monitor User Manual Fetal Monitoring Display Select the forward key to review the next traces. The traces start to advance. The amount of the progress symbol “>” on top of the traces indicates the advancing speed. Rotate the control knob clockwise or touch the symbol to increase the speed until it reaches the maximum.
  • Page 89 F Series Fetal & Maternal Monitor User Manual Fetal Monitoring Display WARNING 1 CTG analysis is used for the surveillance of pregnancies and not in delivery room of childbirth. 2 CTG analysis is just an analysis intended to assist the physicians in interpreting the waveforms.
  • Page 90 F Series Fetal & Maternal Monitor User Manual Fetal Monitoring Display 1) CTG Analysis Timer 2) Analysis Results Figure 8-5 CTG Analysis Results Refer to figure 8-5, the CTG analysis results on the screen include: 1) CTG Analysis Timer: The CTG analysis timer starts when the recorder starts printing; it stops when the timer reaches 60 minutes (the timer turns into >60) and resets when the recorder stops printing.

  • Page 91: Marking A Note

    F Series Fetal & Maternal Monitor User Manual Fetal Monitoring Display At the end of the printing, the recorder prints the CTG analysis results of this moment on the recorder paper. Be aware that CTG analysis result is a calculation output. It can be used as a reference to assist medical personnel in making correct diagnosis, instead of replacing it.

  • Page 92: Numerics

    F Series Fetal & Maternal Monitor User Manual Fetal Monitoring Display 5 Select a note. 6 Use the soft keyboard to edit the note content. 7 Select Enter. 8 Select OK. 8.3 Numerics FHR1 FHR2 TOCO Figure 8-6 Fetal Monitoring Numerics The fetal monitoring values in the numeric window include FHR1/DFHR value, FHR2 value, TOCO/IUP value and FM count: FHR1/DFHR...
  • Page 93 F Series Fetal & Maternal Monitor User Manual Fetal Monitoring Display 141: FHR1/DFHR measurement numeric. If the US1 socket is not connected with a US transducer and DECG socket is not connected with a DECG cable, nothing displays here; if the transducer/cable is connected but no monitoring is going on, it displays ---.

  • Page 94: Changing Numeric Window Position (F9)

    F Series Fetal & Maternal Monitor User Manual Fetal Monitoring Display 8.3.1 Changing Numeric Window Position (F9) Especially for F9, the numeric window can be located either on the right of the traces or on top of them. To change its position, 1 Select the setup key on the main interface.
  • Page 95 F Series Fetal & Maternal Monitor User Manual Fetal Monitoring Display There is no paper in the paper Load paper and/ or close Check Paper Monitor drawer or the drawer is open. the drawer. transducer transducer well US1 UNPLUGGED or Check the connection of the connected.

  • Page 96: Chapter 9 Maternal Monitoring (F6 Express/F9 Express)

    3 Check for any fault of the transducers before applying them to the patient. NOTE: This feature is only available on F6 Express and F9 Express. 9.1 Maternal ECG Monitoring 9.1.1 Introduction ECG monitoring produces a continuous wave form of the patient’s cardiac electric activity to enable an accurate assessment of current physiological state.

  • Page 97: How To Place 3-Lead Ecg Cables

    F Series Fetal & Maternal Monitor User Manual Maternal Monitoring WARNING 3 ECG accessories are not suitable for DIRECT CARDIAC APPLICATION (Refer to IEC60601-1 for more information about the definition of DIRECT CARDIAC APPLICATION). CAUTION A different type of electrodes may produce higher offset voltage. Therefore, only use the ECG leads supplied by the manufacturer when using the monitor for ECG monitoring.

  • Page 98: Ecg Monitoring Procedure

    F Series Fetal & Maternal Monitor User Manual Maternal Monitoring Figure 9-2 Placing 3-lead ECG Cable NOTE: 1 To ensure patient’s safety, all leads must be attached to the patient. 2 Check everyday if the skin is irritated from ECG electrodes, if so, change for new electrodes or change their sites every 24 hours.

  • Page 99: Changing Ecg Gain

    F Series Fetal & Maternal Monitor User Manual Maternal Monitoring 1 Select the setup key on the main interface. 2 Select Mother > Lead. 3 Select I, II (default) or III. 4 Select OK. 9.1.5 Changing ECG Gain You can change the ECG gain. The ECG gain affects overall numeric and scope of the ECG waveform.

  • Page 100: Maternal Spo Monitoring

    F Series Fetal & Maternal Monitor User Manual Maternal Monitoring 9.2 Maternal SpO Monitoring 9.2.1 Introduction The monitor provides continuous monitoring of functional arterial oxygen saturation (SpO ) and pulse rate(PR) for pregnant women. Plethysmogram measurement is employed to determine the oxygen saturation of hemoglobin in the arterial blood.
  • Page 101 F Series Fetal & Maternal Monitor User Manual Maternal Monitoring WARNING 3 Do not perform SpO measuring and NIBP measuring on the same arm at one time, because obstruction of blood flow during NIBP measuring may adversely affect the reading of SpO numeric.

  • Page 102: Spo Monitoring Procedure

    F Series Fetal & Maternal Monitor User Manual Maternal Monitoring 5) Intravascular dye injections. 6) Improper sensor application. 7) Sensor temperature. (Maintain the temperature between +28 °C (+82.4 °F) and +41 °C (+105.8 °F) for best operation) 8) Placement of the sensor, such as on an extremity that has a NIBP cuff, arterial catheter, or intravascular line.

  • Page 103: Enabling Spo Trace Printing

    F Series Fetal & Maternal Monitor User Manual Maternal Monitoring NOTE: 1 The nail should cover the light but not too long. 2 The cable should be placed on the backside of the hand. 3 Avoid external light sources such as radiated rays or ultrared rays. 9.2.3 Enabling SpO Trace Printing The real-time SpO...

  • Page 104: Si (Signal Intensity)

    Maternal Monitoring 9.2.5 SI (Signal Intensity)* *Only applicable to the EDAN module The signal intensity (SI) shows perfusion in numeric, and it reflects the pulse intensity of the measurement site. The SI ranges from 0 to 10, with a larger value indicating the more intense signal.

  • Page 105: Maternal Hr Monitoring

    F Series Fetal & Maternal Monitor User Manual Maternal Monitoring 9.3 Maternal HR Monitoring 9.3.1 Introduction Maternal heart rate (HR) monitoring does not need an extra accessory. When you perform ECG or SpO (Pulse) monitoring, the HR result can be acquired at the same time. When monitoring ECG and SpO at the same time, you can choose the HR source.

  • Page 106: Enabling Hr Trace

    F Series Fetal & Maternal Monitor User Manual Maternal Monitoring 9.3.4 Enabling HR Trace The real-time HR measurement result is displayed in the parameter area of the main interface. Also, you can choose to display and print those as a continuous trace on the recorder paper (refer to figure 5-1).

  • Page 107: Maternal Nibp Monitoring

    F Series Fetal & Maternal Monitor User Manual Maternal Monitoring In the process of monitoring, if the SOV detects signals overlapping, an alarm message “Signals Overlap (FHR1/FHR2, HR)” will appear on the screen to warn you. Checking the patient and reposition of sensors might be needed.

  • Page 108: How To Apply Nibp Cuff

    F Series Fetal & Maternal Monitor User Manual Maternal Monitoring NOTE: The monitor is intended to measure NIBP for adults only. Measurement Limitations - To different patient conditions, the oscillometric measurement has certain limitations. The measurement is in search of regular arterial pressure pulse. In those circumstances where the patient's condition makes it difficult to detect, the measurement becomes unreliable and the measuring time increases.

  • Page 109: Preparation For Nibp Monitoring

    F Series Fetal & Maternal Monitor User Manual Maternal Monitoring 1) Select appropriate cuff for the patient. The table below lists the reference size: Type Limb Perimeter Cuff Size Air Hose Length Upper Arm (Adult 1) 27 cm ~ 35 cm 14.5 cm Upper Arm (Adult 2) 34 cm ~ 43 cm...

  • Page 110: Auto Measurement

    F Series Fetal & Maternal Monitor User Manual Maternal Monitoring 3. Wait for five minutes until the first reading is taken. NOTES: Please roll up the sleeve and keep the patient’s arm bare or it will cause the inaccurate measurements. 1) Wrap the cuff on a bare arm.

  • Page 111: Manual Measurement

    F Series Fetal & Maternal Monitor User Manual Maternal Monitoring 5 Press NIBP key on the front panel to start an Auto measurement. NOTE: The monitor checks uterine contract (UC) pressure when the NIBP key is pressed. If the UC is over 50, a prompt “Intense UC, can't measure NIBP now.” is issued, and the monitor will check the UC every 30 seconds.

  • Page 112: Correcting The Measurement

    F Series Fetal & Maternal Monitor User Manual Maternal Monitoring The monitor checks uterine contract (UC) pressure when the NIBP key is pressed. If the UC is over 50, a prompt “Intense UC, can't measure NIBP now.” is issued. Please wait and do not attempt to measure NIBP until the UC is lower than 50. CAUTION 1 Do not squeeze the rubber tube on the cuff.

  • Page 113: Changing Sys Alarm Limits

    F Series Fetal & Maternal Monitor User Manual Maternal Monitoring 9.4.9 Changing SYS Alarm Limits You can change the SYS alarm limits. 1 Select the setup key on the main interface. 2 Select Alarm. On the displayed Password box, enter 9999, then select Enter. 3 Select SYS.

  • Page 114: Calibrating Nibp

    F Series Fetal & Maternal Monitor User Manual Maternal Monitoring NOTE: The NIBP measurement results during the period of paper lacking and fast printing after new paper is loaded will not be saved or printed. Therefore, do not perform NIBP measurements during this period.

  • Page 115: Changing Temp Unit

    F Series Fetal & Maternal Monitor User Manual Maternal Monitoring 9.5.2 Changing TEMP Unit You can change the TEMP unit. 1 Select the setup key on the main interface. 2 Select Mother > Unit (TEMP Setup). 3 Select ºC (default) or ºF. 4 Select OK.

  • Page 116: Chapter 10 Maternal Monitoring Display (F6 Express/F9 Express)

    Chapter 10 Maternal Monitoring Display (F6 Express/F9 Express) 10.1 *Display Mode F6 Express and F9 Express have three display modes: maternal-fetal display (figure 10-1), fetal display (figure 10-2) and maternal display (figure 10-3). To change the display mode, select the display mode switch on the main interface.
  • Page 117 F Series Fetal & Maternal Monitor User Manual Maternal Monitoring Display Figure 10-2 Fetal Display Mode Figure 10-3 Maternal Display Mode - 106 -...

  • Page 118: Maternal Monitoring Traces

    F6 Express and F9 Express display both maternal monitoring traces and fetal monitoring traces on the same screen. The maternal monitoring traces include ECG waveform and SpO waveform. The fetal monitoring traces are the same as traces of F6/F9, refer to 8.1 Fetal Monitoring Traces for more information. 10.3 Maternal Vital Sign List The maternal vital sign list keeps records of the recent maternal vital signs and the measuring time.

  • Page 119: Numerics

    The maternal vital sign list can be reviewed: select the list and then rotate the control knob to review the previous lists. 10.4 Numerics Besides the fetal numerics, the numeric window of F6 Express / F9 Express includes maternal vital signs: SpO , NIBP, HR and TEMP:...

  • Page 120: Maternal Monitoring Alarm Messages

    (ºC)/(ºF): TEMP unit. 37.2: Current TEMP measurement numeric. 10.5 Maternal Monitoring Alarm Messages Besides the fetal monitoring alarms, F6 Express/F9 Express also gives alarms for the situations that occur during maternal monitoring. The alarm messages are listed below. 10.5.1 Patient Alarm Messages...

  • Page 121: Technical Alarm Messages

    F Series Fetal & Maternal Monitor User Manual Maternal Monitoring Display **SYS HIGH or SYS result (xxx) is higher than the NIBP upper limit (yyy). **SYS xxx > yyy **SYS LOW or SYS result (xxx) is lower than the NIBP upper limit (yyy).
  • Page 122 F Series Fetal & Maternal Monitor User Manual Maternal Monitoring Display Restart the monitor and try board EQUIP again, contact communicate with the system MALF manufacturer successfully. connection still fails. EXCEEDS Check the connection of the ECG/ heart rate exceeds MEASUREMENT ECG leads/SpO sensor and...
  • Page 123 F Series Fetal & Maternal Monitor User Manual Maternal Monitoring Display Check connection SENSOR sensor well sensor finger connected. placement. Restart the monitor and try board EQUIP again, contact communicate with the system MALF manufacturer successfully. connection still fails. TEMP Check connection TEMP...

  • Page 124: Chapter 11 Fts-3 Fetal Telemetry System

    It is not intended for use in intensive care units, operating rooms or for home use. FTS-3 is used with F6, F9 series fetal/maternal monitor and connects to the monitor by signal cable. The wireless transducers monitor the FHR, TOCO parameters within certain distance, and then the base station sends them to the monitor through signal cable, and the monitor can display, alarm, print or review the parameters.

  • Page 125: Base Station

    F9, F9 Express Fetal & Maternal Monitor User Manual FTS-3 Fetal Telemetry System 11.1.1 Base Station Figure 2-1 Top Panel Name Description Docking Slot Place, charge and manage the transducer. Power Indicator When you turn the power supply, the indicator is on. AC Indicator When AC power is supplied, the indicator is on.
  • Page 126 F9, F9 Express Fetal & Maternal Monitor User Manual FTS-3 Fetal Telemetry System 11 12 Figure 2-2 Rear Panel Name Description AC Outlet AC outlet. Communication Socket Communicate to the bedside monitor. Emission Slot Emit the heat. Channel Adjustment Adjust the channel. Button USB port Reserved...
  • Page 127 F9, F9 Express Fetal & Maternal Monitor User Manual FTS-3 Fetal Telemetry System CAUTION 1. This monitor is a normal medical device. Please avoid violent operations such as continuously pressing the power switch. 2. When the transducer is taken up, please do not power off the base station. Figure 2-4 Bottom Name Description...

  • Page 128: Us Transducer And Toco Transducer

    F9, F9 Express Fetal & Maternal Monitor User Manual FTS-3 Fetal Telemetry System 11.1.2 US Transducer and TOCO Transducer US transducer TOCO transducer Name Description Transducer Tied to the pregnant women. Transducer Type Indicate the transducer type. System Working Indicate the system working channel. Channel Signal Indicator Indicate wireless signal strength.

  • Page 129: Installation Guide

    F9, F9 Express Fetal & Maternal Monitor User Manual FTS-3 Fetal Telemetry System 11.2 Installation Guide WARNING The system installation should be operated by serviceman authorized by the manufacturer. 11.2.1 Opening the Package and Checking Visually examine the package prior to unpacking. If any signs of mishandling or damage are detected, contact the carrier to claim for damage.
  • Page 130 F9, F9 Express Fetal & Maternal Monitor User Manual FTS-3 Fetal Telemetry System Take the battery out from package and put it into the compartment. Make sure the battery connector is on the left and the battery label faces down. Anode &...

  • Page 131: Installing The System

    F9, F9 Express Fetal & Maternal Monitor User Manual FTS-3 Fetal Telemetry System Shut the battery compartment cover and fix it with the screws. (2) Battery Removal Remove the battery in reverse order. You can pull the strip at the end to take the battery out from the compartment.

  • Page 132: Connecting Power Cable

    F9, F9 Express Fetal & Maternal Monitor User Manual FTS-3 Fetal Telemetry System CAUTION 3. This equipment has been tested and found to comply with the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation.

  • Page 133: Connect To The Base Station

    F9, F9 Express Fetal & Maternal Monitor User Manual FTS-3 Fetal Telemetry System 11.2.5 Connect to the Base Station 1. Power on the base station. 2. Connect one end of the signal cable to the base station and the other end to the monitor input socket.

  • Page 134: Technical Alarm Messages

    F9, F9 Express Fetal & Maternal Monitor User Manual FTS-3 Fetal Telemetry System NOTE: The working channel number used by a system cannot be duplicate with that used by a device of the same type. 11.3 Technical Alarm Messages When FTS-3 is connected to F9 series fetal/maternal monitor, the monitor gives technical alarms for the situations that need the physicians to pay attention to during wireless monitoring, The alarm messages are listed below.

  • Page 135: Basic Operation

    F9, F9 Express Fetal & Maternal Monitor User Manual FTS-3 Fetal Telemetry System connected to the base station. Check if the Wireless US2 transducer is aimed at the fetal heart; check if the patient moves Wireless US2 SIGNAL FHR2 signal is too weak for the out of the base station RF LOSS system to analyze.

  • Page 136: Basic Function Test

    F9, F9 Express Fetal & Maternal Monitor User Manual FTS-3 Fetal Telemetry System water and coupling gel during charging. When you charge the battery, the screen will display as follows: x Full charging icon: fully charged. x Increasing charging icon: charging x No charging icon: the transducer place in the docking slot incorrectly.

  • Page 137: Patient Application

    F9, F9 Express Fetal & Maternal Monitor User Manual FTS-3 Fetal Telemetry System 7. Touch the measuring area of the TOCO transducer gently: x The fetal monitor displays TOCO value change. 8. Install the US transducer to charge: x The US transducer screen displays charging interface and charging state. x The US transducer indicator is off.

  • Page 138: Monitor The Ambulatory Patient

    F9, F9 Express Fetal & Maternal Monitor User Manual FTS-3 Fetal Telemetry System (less than 3°C (5.4ºF) above ambient temperature). 2. When NOT applied, the wireless ultrasound transducer may warm slightly (less than 3°C (5.4ºF) above ambient temperature). 11.5.3 Monitor the Ambulatory Patient FTS-3 is suitable for ambulatory patients.
  • Page 139 F9, F9 Express Fetal & Maternal Monitor User Manual FTS-3 Fetal Telemetry System Caution 1. Please avoid flushing the transducer during underwater monitoring, or it may cause wireless signal interference. 2. The transducers are watertight to a depth of 1.1 meter for 24 hours, but base station is not waterproof.

  • Page 140: Chapter 12 After Monitoring

    F Series Fetal & Maternal Monitor User Manual After Monitoring Chapter 12 After Monitoring 12.1 Completing Monitoring After monitoring, 1) Remove transducers or electrodes from the patient; wipe the remaining gel off the patient and the transducer with a clean soft cloth or tissue. 2) Press the PRINT key to stop printing, and press the paper advancing key advance the paper.

  • Page 141: Chapter 13 Maintenance And Cleaning

    F Series Fetal & Maternal Monitor User Manual Maintenance and Cleaning Chapter 13 Maintenance and Cleaning 13.1 Maintenance 13.1.1 Maintaining Inspection (1) Visual Inspection Prior to using the monitor or FTS-3 every time, do the following inspections: ‹ Check the monitor and accessories to see if there is any visible evidence of damage that may affect patient safety.

  • Page 142: Maintenance Of Monitor And Base Station

    F Series Fetal & Maternal Monitor User Manual Maintenance and Cleaning 13.1.2 Maintenance of Monitor and Base Station Keep the exterior surface of the monitor and the base station clean, free of dust and dirt. The gathering of dew on the screen may occur with abrupt temperature or humidity changes. A stable environment is recommended.

  • Page 143: Maintaining The Battery

    F Series Fetal & Maternal Monitor User Manual Maintenance and Cleaning 1) Clean the recorder platen with a lint-free cloth dampened in soap/water solution. 2) Wipe the thermal array using a cotton swab moistened with 70% Isopropyl alcohol-based solution. 3) Check that the paper sensing mechanism is free of dust. WARNING Switch off the monitor and remove the power cord prior to recorder cleaning.

  • Page 144: Cleaning Of Accessories

    F Series Fetal & Maternal Monitor User Manual Maintenance and Cleaning CAUTION 1 Although the monitor and the base station are chemically resistant to most common hospital cleaners non-caustic detergents, different cleaners recommended and may stain the monitor. 2 Many cleansers must be diluted before use. Follow the manufacturer’s directions carefully to avoid damaging the monitor and the base station.
  • Page 145 F Series Fetal & Maternal Monitor User Manual Maintenance and Cleaning CAUTION 1 The waterproof parts of the transducer are restricted to the main body and the cable. Do not immerse the plug into water during the process of monitoring or cleaning. 2 Be sure the temperature of cleaning solutions does not exceed +45 ºC (+113 ºF).

  • Page 146: Disinfecting

    F Series Fetal & Maternal Monitor User Manual Maintenance and Cleaning CAUTION 1 Do not squeeze the rubber tube on the cuff. 2 Do not dry-clean the cuff. 3 Only clean the outer surface of the connectors, make sure no liquid goes into the connector.

  • Page 147: Sterilizing

    F Series Fetal & Maternal Monitor User Manual Maintenance and Cleaning CAUTION 1 Do not use any disinfectant containing additional active ingredients other than those listed. 2 Follow the manufacturer’s instruction to dilute the solution, or adopt the lowest possible density. 3 Do not immerse any part of the monitor or any accessory into liquid.

  • Page 148: Chapter 14 Warranty And Service

    EDAN will, at its discretion, repair or replace the defective part(s) free of charge. EDAN will not provide a substitute product for use when the defective product is being repaired.

  • Page 149: Appendix 1 Product Specifications

    15% ~ 93% (non-condensing) Atmospheric Pressure: 700hPa ~ 1060hPa A1.2 Physical Specifications Monitor Size (depth x width x height): 347mm × 330mm × 126mm F6: Approx. 5.3 kg Dimensions and Weight F6 Express: Approx. 6.1kg Weight: F9: Approx. 5.5 kg F9 Express: Approx.
  • Page 150 Equipment not suitable for use in presence of flammable Flammable Gases gases Disinfection/Sterilizing Method: Refer to this user manual for details CISPR11 Group 1 Class A Working System Continuous running equipment Display (F6/F6 Express) LCD Size: 10.1” (Diagonal) Resolution: 800 × 480 Display (F9/F9 Express) Screen Diagonal: 12.1”...

  • Page 151: A1.3 Performance Specifications

    F Series Fetal & Maternal Monitor User Manual Product Specifications Dimension: 88 mm × 35 mm TOCO Transducer Cable Length: 2.5 m Weight: 180 g Dimension: 88 mm × 35 mm Remote Event Marker Length: 2.5 m Weight: 56 g Cable Length: Weight: 213 g...
  • Page 152 Max Output Power <15mW Effective Radiating Area: 942 mm ± 15% FHR Measurement Range: 50 bpm ~ 240 bpm Resolution: 1 bpm ±2 bpm (F6/F6 Express) Accuracy: ±1 bpm (F9/F9 Express) Dielectric Strength: 4000Vrms Maximum transducer Less than 5 qC (9ºF)
  • Page 153 F Series Fetal & Maternal Monitor User Manual Product Specifications Non-linear Error: ± 3mmHg Resolution: Zero Mode: Manual Fetal Movement Technique: Pulsed Doppler ultrasound FM Mode Automatic/Manual AFM Mode Trace or blackmark Display 0-999 Range HR Measurement Range: 30 bpm ~ 240 bpm Input Signal Range: ±8 mV PP HR Measuring Accuracy:...
  • Page 154 HR averaging method recent RR intervals. Measurement Range: 50% ~ 100% Resolution: 90% ~ 100% ± 2% Measuring Accuracy 70% ~ 90% ± 4% (EDAN): < 70% unspecified 70% ~ 100% ± 2% Measuring Accuracy (Nellcor): < 70% unspecified 2 seconds (typically)

  • Page 155: A1.4 Recorder Specifications

    F Series Fetal & Maternal Monitor User Manual Product Specifications Infrared light (905r10) nm Emitted light energy < 15 mW Information about the wave length range can be especially useful to clinicians (for instance, when photodynamic therapy is performed.) Measurement Range: Systolic pressure: 40mmHg ~ 270mmHg Diastolic pressure:...

  • Page 156: A1.5 Rechargeable Lithium-Ion Battery

    F Series Fetal & Maternal Monitor User Manual Product Specifications 110mm (American Standard) Effective printing width: 120mm (International Standard) 70mm (American Standard) FHR printout width: 80mm (International Standard) 30bpm/cm (American Standard) FHR scaling: 20bpm/cm (International Standard) TOCO printout width: 40mm TOCO scaling: 25%/cm Printing speed:...

  • Page 157: A1.6 Low Output Summary Table

    (for systems with no transducers having global maximum index values exceeding 1.0) System: Fetal & maternal Monitor Ipa.3@MI spta.3 Transducer Model TI Type TI Value (mW/cm (W/cm PW1.0MHz 0.006149 1.288 0.01405 0.007225 (F6/F6 Express US 0.04687 Transducer) PW1.0MHz 0.008761 1.817 0.01567 0.01025 (F9/F9 Express US 0.05723 Transducer) - 146 -...

  • Page 158: B Fts-3 Fetal Telemetry System

    F Series Fetal & Maternal Monitor User Manual Product Specifications B FTS-3 Fetal Telemetry System B1.1 Environmental Specifications Temperature: +5 ºC ~ +40 ºC (+41ºF ~ +104ºF) Working Relative Humidity: 15% ~ 93% (non-condensing) Atmospheric Pressure: 860hPa ~ 1060hPa Temperature: -20 ºC ~ +55 ºC (-4ºF ~ +131 ºF) Transport and Storage Relative Humidity:...

  • Page 159: B1.3 Performance Specifications

    F Series Fetal & Maternal Monitor User Manual Product Specifications Disinfection/Sterilizing Refer to this user manual for details Method CISPR11 Group 1 Class A N.C. S.F.C. Ground Leakage Current (Limit): 500μA 1000μA N.C. S.F.C. Enclosure Leakage Current (Limit) 100μA 500μA N.C.
  • Page 160 F Series Fetal & Maternal Monitor User Manual Product Specifications < 1 MPa <10 mW/cm <100 mW/cm spta FHR Measurement Range: 50 bpm 240 bpm Resolution: 1 bpm Accuracy: ±2 bpm Dielectric Strength: 4000 Vrms TOCO TOCO Range: 0% ~ 100% Non-linear Error: ±10% 1 unit/min/°C (free air)

  • Page 161: B1.4 Rechargeable Lithium-Ion Battery

    F Series Fetal & Maternal Monitor User Manual Product Specifications B1.4 Rechargeable Lithium-ion Battery Base Station Battery 5000 mAh Nominal Capacity: Continuous Work •40 Hours Time: 14.8 V Nominal Voltage: Necessary Charge ”14 Hours Time: >300 times Cycle Life: Transducer Battery 1600 mAh Nominal Capacity: Charge...

  • Page 162: Appendix 2 Signal Input/Output Connector

    F Series Fetal & Maternal Monitor User Manual Signal Input/Output Connector Appendix 2 Signal Input/Output Connector Accessory equipment connected to these interfaces must be certified according to the respective IEC/EN standards (e.g. IEC/EN 60950 for data processing equipment and IEC/EN 60601-1 for medical equipment).
  • Page 163 F Series Fetal & Maternal Monitor User Manual Signal Input/Output Connector Signal Input/Output RJ45 Interface Output Output Input Reserved Reserved Input Reserved Reserved CAUTION Only the PC recommended by the manufacturer can be connected to the signal input/output interface of the monitor. Other equipment is forbidden. - 152 -...

  • Page 164: Appendix 3 Troubleshooting

    F Series Fetal & Maternal Monitor User Manual Troubleshooting Appendix 3 Troubleshooting A3.1 No Display Phenomenon Possible Cause Solution Power cable is loose. Tighten the power cable. Power indicator is off. The fuse is blown. Change the fuse. The battery runs out of power. Connect to AC power supply.

  • Page 165: A3.4 Trouble With Ultrasound Fhr Monitoring

    F Series Fetal & Maternal Monitor User Manual Troubleshooting A3.4 Trouble with Ultrasound FHR Monitoring Phenomenon Possible Cause Solution The patient is overweighted. Monitor FHR with DECG. Adjust position Improper ultrasound transducer transducer till the better signal is position. received. Loose belt.

  • Page 166: A3.6 Troubles With Contractions Monitoring (External)

    F Series Fetal & Maternal Monitor User Manual Troubleshooting The DECG cable has not been Fix an attachment pad at the Inconstant trend fixed firmly DECG cable. A3.6 Troubles with Contractions Monitoring (External) Phenomenon Possible Cause Solution The belt is too tight or too loose. Adjust the belt.

  • Page 167: A3.8 Big Ecg Signal Interference Or Thick Baseline

    F Series Fetal & Maternal Monitor User Manual Troubleshooting A3.8 Big ECG Signal Interference or Thick Baseline Phenomenon Possible Cause Solution Check the electrodes placing and Abnormal electrodes placing or the period of validity of electrodes. electrodes invalidation. The cable connector is not well Check the connection of cable connected.
  • Page 168 F Series Fetal & Maternal Monitor User Manual Troubleshooting To replace a fuse: Fold the LCD display completely flat. Carefully place the monitor upside down on a flat surface covered with cloth or other protecting pad. With a flat-head screw driver, push the fuse in for about 1 mm and then unscrew it anticlockwise.

  • Page 169: B Fts-3 Fetal Telemetry System

    F Series Fetal & Maternal Monitor User Manual Ultrasound Intensity and Safety B FTS-3 Fetal Telemetry System B3.1 Troubleshooting Phenomenon Possible Cause Solution Recharge the transducer. It runs out of power. Put it back in the docking Take out the US transducer, The base station cannot slot and take it up again.
  • Page 170 F Series Fetal & Maternal Monitor User Manual Ultrasound Intensity and Safety To replace a fuse: 1) Place the base station on a flat surface and remove the power cord. 2) Reverse the base station and pull the fuse container out as far as it can go. 3) Use a screw driver or a pair of pliers to push the fuse up from the bottom of the container.
  • Page 171 F Series Fetal & Maternal Monitor User Manual Ultrasound Intensity and Safety 5) Push the fuse container all the way back in position. - 160 -...

  • Page 172: Appendix 4 Ultrasound Intensity And Safety

    F Series Fetal & Maternal Monitor User Manual Ultrasound Intensity and Safety Appendix 4 Ultrasound Intensity and Safety A4.1 Ultrasound in Medicine The use of diagnostic ultrasound has proved to be a valuable tool in medical practice. Given its known benefits for non-invasive investigations and medical diagnosis, including investigation of the human fetus, the question of clinical safety with regards to ultrasound intensity arises.

  • Page 173: A4.3.2 Ti (Thermal Index)

    F Series Fetal & Maternal Monitor User Manual Ultrasound Intensity and Safety MI = ˜ C = 1 (MPa / MHz ) A4.3.2 TI (Thermal Index) Heating of tissues is caused by absorption of ultrasound when the ultrasound energy is applied. The temperature rise is determined by the acoustic intensity, exposed area and thermophysical properties of the tissue.

  • Page 174: A4.4 Prudent Use Statement

    F Series Fetal & Maternal Monitor User Manual Ultrasound Intensity and Safety pressure values and ± 14.52 percent for the Mechanical Index. A4.4 Prudent Use Statement Although no confirmed bioeffects on patients caused by exposure from present diagnostic ultrasound equipment have ever been reported, the potential exists that such bioeffects may be identified in the future.

  • Page 175: A4.6 Probe Acoustic Output Parameters List

    F Series Fetal & Maternal Monitor User Manual Ultrasound Intensity and Safety A4.6 Probe Acoustic Output Parameters List A4.6.1 Test of Wired Probe Acoustic Output Reporting Table (F9/F9 Express) Operating Mode: PW mode Working Frequency: 1.0MHz Index Label Non-scan Scan Non-scan Aaprt”1 Aaprt>1...
  • Page 176 F Series Fetal & Maternal Monitor User Manual Ultrasound Intensity and Safety Operating Mode: PW mode Working Frequency: 1.0MHz spta.3 sppa.3 Acoustic Output (mW/cm (W/cm Global Maximum Value 0.01567 1.817 0.01025 (MPa) 0.01567 (mW) 11.52 11.52 (MHz) 1.00 1.00 1.00 (cm) 13.65 13.65...
  • Page 177 F Series Fetal & Maternal Monitor User Manual Ultrasound Intensity and Safety Acoustic Output Reporting Table (F6/F6 Express) Operating Mode: PW mode Working Frequency: 1.0MHz Non-scan Index Label Scan Non-sca Aaprt” Aaprt>1 Global Maximum Index Value 0.01405 0.006149 0.04687 (MPa) 0.01405...
  • Page 178 F Series Fetal & Maternal Monitor User Manual Ultrasound Intensity and Safety Operating Mode: PW mode Working Frequency: 1.0MHz spta.3 sppa.3 Acoustic Output (mW/cm (W/cm Global Maximum Value 0.01405 1.288 0.007225 (MPa) 0.01405 (mW) 10.70 10.70 (MHz) 1.00 1.00 1.00 (cm) 13.30 13.30...

  • Page 179: A4.6.2 Test Of Wireless Probe (Fts-3)

    F Series Fetal & Maternal Monitor User Manual Abbreviation A4.6.2 Test of Wireless Probe (FTS-3) Acoustic Output Reporting Table Operating Mode: PW mode Working Frequency: 1.0MHz Index Label Non-scan Scan Non-scan Aaprt”1 Aaprt>1 Global Maximum Index Value 0.01087 0.002949 0.01939 (MPa) 0.01087 (mW)
  • Page 180 F Series Fetal & Maternal Monitor User Manual Abbreviation Operating Mode: PW mode Working Frequency: 1.0MHz spta.3 sppa.3 Acoustic Output (mW/cm (W/cm Global Maximum Value 0.01087 0.6186 0.003412 (MPa) 0.01087 (mW) 3.496 3.496 (MHz) 1.00 1.00 1.00 (cm) 11.80 11.80 11.80 (cm) 0.5663...

  • Page 181: Appendix 5 Abbreviation

    F Series Fetal & Maternal Monitor User Manual Abbreviation Appendix 5 Abbreviation The abbreviations used in this manual and their full names are listed below: Abbreviation Full Name Alternative Current Automatic Fetal Movement [Detection] Beat(s) Per Minute Cardiotocography Direct Current DECG Direct ECG DFHR...
  • Page 182 F Series Fetal & Maternal Monitor User Manual Abbreviation Short-Term Variation Systolic Blood Pressure TEMP Temperature TOCO Tocotonometer Uterine Activity [TOCO] Ultrasound [Transducer] - 171 -...

  • Page 183: Appendix 6 Ordering Information

    Part Number 02.01.31528 US Transducer 1 (purple label, for F9/F9 Express) 02.01.107705 US Transducer 2 (yellow label, for F9/F9 Express) US Transducer (pink label, for F6/F6 Express) 02.01.109301 Wireless US Transducer (American Standard) 02.01.000925 Wireless TOCO Transducer (American Standard) 02.01.000926 83.62.001974...
  • Page 184 F Series Fetal & Maternal Monitor User Manual Ordering Information Disposable ECG Electrode (US) 01.57.471276 Sensor 02.01.109069 NIBP Cuff (Upper Arm Perimeter 27cm-35cm, for Adult) 01.57.471330 NIBP Cuff Extension Tube 01.57.471005 TEMP Sensor 01.15.040187 Thermosensitive Recorder Paper (GE-American) 01.57.75111 Thermosensitive Recorder Paper (GE-International) 01.57.75112 Thermosensitive Recorder Paper (Philips-American) 01.57.75113...

  • Page 185: Appendix 7 Emc Information

    F Series Fetal & Maternal Monitor User Manual EMC Information Appendix 7 EMC Information A7.1 Electromagnetic Emissions Guidance and manufacture’s declaration – electromagnetic emission The F Series Fetal & maternal Monitor is intended for use in the electromagnetic environment specified below. The customer of the user of the F Series Fetal & maternal Monitor should assure that it is used in such and environment.

  • Page 186: A7.2 Electromagnetic Immunity

    F Series Fetal & Maternal Monitor User Manual EMC Information A7.2 Electromagnetic Immunity Guidance and manufacture’s declaration – electromagnetic immunity The F Series Fetal & maternal Monitor is intended for use in the electromagnetic environment specified below. The customer or the user of F Series Fetal & maternal Monitor should assure that it is used in such an environment.
  • Page 187 F Series Fetal & Maternal Monitor User Manual EMC Information < 5% U < 5% U (> 95% dip in U (> 95% dip in U for 0.5 cycle for 0.5 cycle Mains power quality should be 40% U 40% U that of a typical commercial or hospital environment.

  • Page 188: A7.3 Electromagnetic Immunity

    F Series Fetal & Maternal Monitor User Manual EMC Information A7.3 Electromagnetic Immunity Guidance and manufacture’s declaration – electromagnetic immunity The F Series Fetal & maternal Monitor is intended for use in the electromagnetic environment specified below. The customer or the user of F Series Fetal & maternal Monitor should assure that it is used in such an environment.
  • Page 189 F Series Fetal & Maternal Monitor User Manual EMC Information NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy.

  • Page 190: A7.4 Recommended Separation Distances

    F Series Fetal & Maternal Monitor User Manual EMC Information A7.4 Recommended Separation Distances Recommended separation distances between portable and mobile RF communications equipment and the F Series Fetal & maternal Monitor The F Series Fetal & maternal Monitor is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.

  • Page 191: Appendix 8 Limitations Of Ultrasonic Monitoring

    F Series Fetal & Maternal Monitor User Manual Limitations of Ultrasonic Monitoring Appendix 8 Limitations of Ultrasonic Monitoring A8.1 How Does Ultrasound Work When the ultrasound waves strike an object, they bounce back and create an echo. If the object moves toward the sound source, the frequency of the echo increases.
  • Page 192 F Series Fetal & Maternal Monitor User Manual Limitations of Ultrasonic Monitoring (3) Halving: When the FHR increases to 180 bpm or higher, it is possible for the monitor to mistake the two separate hearbeats for the diastole and systole of a single heartbeat. As a result, a heart rate trace that is half the actual heart rate is produced.

  • Page 193: A8.3 Audio Output And Screen Reading

    F Series Fetal & Maternal Monitor User Manual Limitations of Ultrasonic Monitoring Stethoscopy should be applied when sudden changes in baseline are detected. If the amniotic membrane rupture and cervical dilatation are sufficient, consider using a spiral electrode to obtain precise FHR with direct fetal ECG as the signal source. (4) Erratic Traces / Drop out When the fetal heart moves partially out of the ultrasound wave path, the transducer receives mixed or weak signals, and thereby the monitor presents erratic traces.

This manual is also suitable for:

F9 expressF9

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