EDAN F9 User Manual
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EDAN F9 User Manual

Fetal & maternal monitor
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EDAN Agile PLM Electronic Signature Information
--Signatures related to this document and performed in EDAN Agile PLM.
文件名称(Document Name)：F9说明书_英文
文件编号(Number)：01.54.107779
版本(Version)：2.9
产品型号(Product Model)：F9;F9 Express
项目编码(Project Code)：2040A000
签批信息(Signature):
作者(Originator) : 周 睿 (zhourui)
2018-10-15 15:36:46
审核人(Reviewers) : 刘 小倩 (liuxiaoqian)
2018-10-15 17:03:21
审核人(Reviewers) : 唐 林 (tanglin)
2018-10-16 09:10:49
审核人(Reviewers) : 明 镭 (minglei)
2018-10-16 13:54:54
审核人(Reviewers) : 张 冬雪 (zhangdongxue)
2018-10-19 12:04:28
审核人(Reviewers) : 占 皓 (zhanhao)
2018-10-29 09:12:01
审核人(Reviewers) : 余 俊煜 (yujunyu)
2018-10-16 18:54:43
批准人(Approvers) : 夏 欢欢 (xiahuanhuan)
2018-11-02 10:35:44
批准人(Approvers) : 吴 明花 (wuminghua)
2018-11-07 14:20:44
批准人(Approvers) : 冀 伟 (jiwei)
2018-11-02 15:35:48
版权©深圳市理邦精密仪器股份有限公司 (Copyright©Edan Instrument,Inc.)

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  • Page 1 EDAN Agile PLM Electronic Signature Information --Signatures related to this document and performed in EDAN Agile PLM. 文件名称(Document Name)：F9说明书_英文 文件编号(Number)：01.54.107779 版本(Version)：2.9 产品型号(Product Model)：F9;F9 Express 项目编码(Project Code)：2040A000 签批信息(Signature): 作者(Originator) : 周 睿 (zhourui) 2018-10-15 15:36:46 审核人(Reviewers) : 刘 小倩 (liuxiaoqian) 2018-10-15 17:03:21 审核人(Reviewers) : 唐...
  • Page 3 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 4 A WARNING label advises against certain actions or situations that could result in personal injury or death. CAUTION A CAUTION label advises against actions or situations that could damage equipment, produce inaccurate data, or invalidate a procedure. NOTE A NOTE provides useful information regarding a function or a procedure.

  • Page 5: Table Of Contents

    Table of Contents Chapter 1 Safety Guidance ......................1 1.1 Intended Use/Indications for 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 Introducing the Monitor ...................
  • Page 6 3.2.1 Opening the Package and Checking ................40 3.2.2 Installing Battery ......................41 3.2.3 Installing the System ...................... 43 3.2.4 Connecting Power Cable ....................43 3.2.5 Configuration ......................... 44 3.2.6 Connecting to the Monitor ..................... 44 3.2.7 Adjusting the Working Channel ..................44 3.3 Basic Operation ........................
  • Page 7 5.2.6 Changing Title Print Cycle ..................... 68 5.2.7 Switching Maternal Monitor Information On or Off ............. 68 5.3 Understanding Recorder Paper Printout ................69 Chapter 6 Pre-Monitoring Preparation ..................71 6.1 Loading Recorder paper ....................... 71 6.2 Switching On the Monitor ....................73 6.3 Checking the Recorder Paper ....................
  • Page 8 7.9.1 Auto ID ........................... 99 7.9.2 Changing Maternal Information ..................99 7.9.3 Switching Mat. Info Inputting On or Off ..............100 Chapter 8 Fetal Monitoring Display (F9) ................102 8.1 Traces ..........................102 8.1.1 Changing Time Scale ....................104 8.2 Trace Control Tools ......................104 8.2.1 Data Saving ........................
  • Page 9 9.5.2 Changing TEMP Unit ....................135 9.5.3 Switching the TEMP Alarm On or Off ................ 136 9.5.4 Changing TEMP Alarm Limits ..................136 Chapter 10 Maternal Monitoring Display (F9 Express) ............137 10.1 *Display Mode ......................... 137 10.2 Maternal Monitoring Traces ..................... 140 10.3 Maternal Vital Sign List ....................
  • Page 10 Chapter 13 Warranty and Service.................... 153 13.1 Warranty ........................... 153 13.2 Contact information ......................153 Appendix 1 Product Specifications ................... 154 A F9, F9 Express Fetal/Maternal Monitor ................154 A1.1 Environmental Specifications ..................154 A1.2 Physical Specifications ....................154 A1.3 Performance Specifications ..................156 A1.4 Recorder Specifications ....................
  • Page 11 A4.6.1 Test of Wired Transducer ..................183 A4.6.2 Test of Wireless Transducer (FTS-3)................. 184 A4.6.3 Standard Parameter Equal Contrast List ..............187 Appendix 5 Abbreviation ......................189 Appendix 6 Ordering Information ................... 191 Appendix 7 EMC Information ....................194 A7.1 Electromagnetic Emissions ....................194 A7.2 Electromagnetic Immunity ....................

  • Page 12: Chapter 1 Safety Guidance

    1.1 Intended Use/Indications for Use F9 Fetal & Maternal Monitor (hereinafter called F9): The 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 both F9 and F9 Express, and is used where the information applies to both 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

    F9, F9 Express Fetal & Maternal Monitor User Manual Safety Guidance  The monitor must be serviced only by authorized and qualified personnel. The manufacturer 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.

  • Page 15: Safety Precautions

    F9, F9 Express Fetal & Maternal Monitor User Manual Safety Guidance 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 use of qualified physicians or personnel professionally trained.
  • Page 16 F9, F9 Express Fetal & Maternal Monitor User Manual Safety Guidance WARNING 12 Connecting any accessory (such as external printer) or other device (such as the computer) to this monitor makes a medical system. In that case, additional safety measures should be taken during installation of the system, and the system shall...
  • Page 17 F9, F9 Express Fetal & Maternal Monitor User Manual Safety Guidance WARNING 24 Only connect accessories supplied or recommended by the manufacturer to the device. 25 The system should be operated by the doctor or under the doctor’s instructions. 26 Do not apply the monitor during electro-surgery or MRI; otherwise it might result in harming the patient or the operator.
  • Page 18 43 Before using the rechargeable lithium-ion battery (hereinafter called battery), be sure to read the user manual and safety precautions thoroughly. 44 Use the battery only in the F9 or F9 Express monitor. 45 Do not reverse the battery pole or it will cause explosion.
  • Page 19 F9, F9 Express Fetal & Maternal Monitor User Manual Safety Guidance WARNING For network safety: 63 Given the vulnerabilities of WEP, it is advised to use WAP and WAP2. WEP should not be used as it is not secure. 64 Data in transit is no encrypted. Local Area Network isolation or other protections are suggested to prevent unintended exposure of PHI.
  • Page 20 F9, F9 Express Fetal & Maternal Monitor User Manual Safety Guidance CAUTION Do not sterilize the monitor or any accessory with autoclave or gas. Switch off the system power before cleaning. Cleaning consists of removing all dust from the exterior surface of the equipment with a soft brush or cloth.
  • Page 21 F9, F9 Express Fetal & Maternal Monitor User Manual Safety Guidance CAUTION 21 If the terminals of the battery become dirty, wipe with a dry cloth before using the battery. 22 The device and accessories are to be disposed of according to local regulations after their useful lives.

  • Page 22: Definitions And Symbols

    F9, F9 Express Fetal & Maternal Monitor User Manual Safety Guidance 1.6 Definitions and Symbols F9, F9 Express Fetal & Maternal Monitor Socket for ultrasound transducer 1 ( Type BF applied part) Socket for ultrasound transducer 2 ( Type BF applied part)
  • Page 23 F9, F9 Express Fetal & Maternal Monitor User Manual Safety Guidance Equipotentiality Battery check Alternating Current Stand-by Caution Warning (Background: Yellow; Symbol & outline: Black) Operating instructions Refer to User Manual (Background: Blue; Symbol: White) Type BF applied part Defibrillation-proof type BF applied part...
  • Page 24 F9, F9 Express Fetal & Maternal Monitor User Manual Safety Guidance Part 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...
  • Page 25 F9, F9 Express Fetal & Maternal Monitor User Manual Safety Guidance Non-ionizing electromagnetic radiation Serial Number Wireless Transducer Working Indicator USB Port (Reserved) Ethernet Port (Reserved) Channel Adjustment NOTE: The user manual is printed in black and white. - 14 -...

  • Page 26: Chapter 2 Introducing The Monitor

    F9, F9 Express Fetal & Maternal Monitor User Manual Introducing the Monitor Chapter 2 Introducing the Monitor 2.1 Installation Guide NOTE: Installation must be carried out by qualified personnel authorized by the manufacturer. 2.1.1 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 27 F9, F9 Express Fetal & Maternal Monitor User Manual Introducing the Monitor c) Take the battery out from package. Put the battery and the cables into the battery compartment and insert the cable connector into the socket. d) Shut the battery compartment cover and fix the screws.

  • Page 28: Installing Monitor

    F9, F9 Express Fetal & Maternal Monitor User Manual Introducing the Monitor 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: Overview

    F9, F9 Express Fetal & Maternal Monitor User Manual Introducing the Monitor monitor shuts down and resumes the previous settings at the subsequent operation. 2.2 Overview NOTE: The pictures and interfaces in this manual are for reference only. 1 Keys...
  • Page 30 F9, F9 Express Fetal & Maternal Monitor User Manual Introducing the Monitor 20 POWER Switch Figure 2-3 Right Panel 21 Equipotential Grounding Terminal 22 Antenna 23 USB Socket 24 RJ45 Socket 25 D-Sub Socket 26 Handle Figure 2-4 Rear Panel...

  • Page 31: Keys

    F9, F9 Express Fetal & Maternal Monitor User Manual Introducing the Monitor 2.2.1 Keys Figure 2-6 Keys and Control Knob 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:...
  • Page 32 F9, F9 Express Fetal & Maternal Monitor User Manual Introducing the Monitor CHANNEL Function: Switch the channels The monitor has two separate channels (channel 1 and channel 2). The default fetal heart sound comes from channel 1. When two transducers are connected to the monitor, press this key to switch the sound to channel 2;...

  • Page 33: Indicators

    F9, F9 Express Fetal & Maternal Monitor User Manual Introducing the Monitor is valid, and gives a sharp “Di” sound when the operation is invalid. CAUTION This monitor is a normal medical device. Please avoid violent operations such as continuously pressing the keys or control knob.

  • Page 34: Ultrasound (Us) Transducers

    F9, F9 Express Fetal & Maternal Monitor User Manual Introducing the Monitor 2.3.1 Ultrasound (US) Transducers 1 US Transducer Sensor (Purple, yellow labeled) 2 Transducer Cable 3 Transducer Connector Figure 2-7 US Transducers 2.3.2 TOCO Transducers 1 TOCOS Transducer Sensor...

  • Page 35: Remote Event Marker

    F9, F9 Express Fetal & Maternal Monitor User Manual Introducing the Monitor 2.3.4 Remote Event Marker 1 Marker Plug 2 Press Key Figure 2-10 Remote Event Marker 2.3.5 Fetal Stimulator FS-1 Fetal Stimulator is a hand-held device. In order to reduce the time required for the NST when the fetus is asleep, it can be used to give a mild vibrating stimulation to the fetus through the maternal abdomen.

  • Page 36: Decg Cable

    F9, F9 Express Fetal & Maternal Monitor User Manual Introducing the Monitor 2.3.6 DECG Cable 1 DECG Cable Plug 2 DECG Cable Connector Figure 2-12 DECG Cable 2.3.7 Fetal Spiral Electrode Figure 2-13 Fetal Spiral Electrode Reference Electrode Drive Tube...

  • Page 37: Iup Catheter

    F9, F9 Express Fetal & Maternal Monitor User Manual Introducing the Monitor 2.3.9 IUP Catheter 1 Interface to Connecting Cable 2 Catheter Figure 2-16 IUP Catheter 2.3.10 ECG Cable 1 ECG Connector 2 ECG Fastener 3 Lead Wire Figure 2-17 3-Lead ECG Cable 2.3.11 SpO...

  • Page 38: Nibp Cuff

    F9, F9 Express Fetal & Maternal Monitor User Manual Introducing the Monitor 2.3.12 NIBP Cuff 1 NIBP Cuff 2 Cuff Extension Tube Figure 2-19 NIBP Cuff Figure 2-20 Cuff Extension Tube 2.3.13 TEMP Sensor 1 TEMP Sensor 2 TEMP Connector...

  • Page 39: Screen

    F9, F9 Express Fetal & Maternal Monitor User Manual Introducing the Monitor 2.4 Screen 2.4.1 Main Interface Message Window Numeric Window Trace/Menu Window Status Figure 2-22 Main Interface Window Background Color Switch The main interface of the monitor displays traces, waves, numerics, menus and monitor status information.
  • Page 40 : Paper advancing key. Select this key to advance the paper for 8 cm (PHILIPS paper) or 7 cm (GE paper). : Display mode switch. F9 Express monitor has 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 41 F9, F9 Express Fetal & Maternal Monitor User Manual Introducing the Monitor (4) Status Window Power indicator - AC power supplied. - no AC power supplied. Battery indicator The battery is loaded into the monitor with 100% capacity 75% capacity...

  • Page 42: Setup Interface

    F9, F9 Express Fetal & Maternal Monitor User Manual Introducing the Monitor - the monitor is online. - the monitor is offline. NOTE: The network connection indicator is not available if the net version is Insight or Philips. Audio alarm indicator - the audible alarm is switched on.

  • Page 43: Touch Screen

    F9, F9 Express Fetal & Maternal Monitor User Manual Introducing the Monitor Setup Items Software Version Function description Figure 2-23 Setup Interface 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 44 F9, F9 Express Fetal & Maternal Monitor User Manual Introducing the Monitor item. Touch the symbol to increase the numeric or move leftwards. While touching the will decrease the numeric or move rightwards. To exit from the submenu, you should touch the item again or touch any place outside the area of the options.

  • Page 45: Chapter 3 Introducing The 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 46: Base Station

    F9, F9 Express Fetal & Maternal Monitor User Manual Introducing the FTS-3 Fetal Telemetry System 3.1.1 Base Station Figure 3-1 Top Panel Name Description Docking Slot Place, charge and manage the transducer. Power Indicator When you turn the power supply, the indicator is on.
  • Page 47 F9, F9 Express Fetal & Maternal Monitor User Manual Introducing the FTS-3 Fetal Telemetry System 11 12 Figure 3-2 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.
  • Page 48 F9, F9 Express Fetal & Maternal Monitor User Manual Introducing the 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.

  • Page 49: Transducers

    F9, F9 Express Fetal & Maternal Monitor User Manual Introducing the FTS-3 Fetal Telemetry System 3.1.2 Transducers Figure 3-5 US-T transducer Figure 3-6 TOCO-T transducer Figure 3-7 TOCO-E transducer Name Description Transducer Tied to the pregnant women. Transducer Type Indicate the transducer type.

  • Page 50: Accessories

    F9, F9 Express Fetal & Maternal Monitor User Manual Introducing the FTS-3 Fetal Telemetry System Battery Indicator Indicate battery level. 1. Display “TOCO/DECG” when connected to DECG cable; 2. Display “TOCO/MECG” when connected to TOCO-E Display MECG cable; 3. Display “TOCO” when not connected to DECG cable or MECG cable.

  • Page 51: Features

    F9, F9 Express Fetal & Maternal Monitor User Manual Introducing the FTS-3 Fetal Telemetry System  FTS-3 MECG Cable MECG Connector MECG Fastener Lead Wire Figure 3-9 2-lead MECG Cable 3.1.4 Features  Long work distance and free to walk in a great range ...

  • Page 52: Installing Battery

    F9, F9 Express Fetal & Maternal Monitor User Manual Introducing the FTS-3 Fetal Telemetry System Open the package; take out the base station and accessories carefully. Keep the package for possible future transportation or storage. Check the components according to the packing list.
  • Page 53 F9, F9 Express Fetal & Maternal Monitor User Manual Introducing the 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.

  • Page 54: Installing The System

    F9, F9 Express Fetal & Maternal Monitor User Manual Introducing the FTS-3 Fetal Telemetry System 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 When the battery configuration is provided, after the device is transported or stored, the battery must be charged.

  • Page 55: Configuration

    F9, F9 Express Fetal & Maternal Monitor User Manual Introducing the FTS-3 Fetal Telemetry System When the supply mains are interrupted, the device switches to internal power supply and operates normally if the battery is installed. If the battery is not installed, the system shuts down and resumes the previous settings at the subsequent operation.

  • Page 56: Basic Operation

    F9, F9 Express Fetal & Maternal Monitor User Manual Introducing the 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. 3.3 Basic Operation 3.3.1 Charge the Transducer...
  • Page 57 F9, F9 Express Fetal & Maternal Monitor User Manual Introducing the FTS-3 Fetal Telemetry System Please wipe the transducer and the charging point with a dry cloth before charging the transducer. Please do not scratch the charging point. The battery is installed in the transducer. If the base station is switched on and supplied by AC, the battery will be charged automatically when it is placed in the docking slot.

  • Page 58: General Application

    F9, F9 Express Fetal & Maternal Monitor User Manual Introducing the FTS-3 Fetal Telemetry System  Take up the transducer or adjust the working channel to exit from the screensaver. It takes about 3.5 hours to charge the battery. It is recommended to place the transducer in the docking slot when the transducer is not used for a long time.

  • Page 59: Relocation Of The Transducers

    F9, F9 Express Fetal & Maternal Monitor User Manual Introducing the FTS-3 Fetal Telemetry System 6. When applied to the patient, the wireless ultrasound transducer may warm slightly (less than 3° C (5.4º F) above ambient temperature). When NOT applied, the wireless ultrasound transducer may warm slightly (less than 3°...

  • Page 60: Underwater Monitoring

    F9, F9 Express Fetal & Maternal Monitor User Manual Introducing the FTS-3 Fetal Telemetry System  The patient should not walk in strong tramps.  The patient should move in the prescriptive area.  The patient should be under monitoring when the wireless signal is good.

  • Page 61: Priority

    F9, F9 Express Fetal & Maternal Monitor User Manual Introducing the FTS-3 Fetal Telemetry System Caution 3. Underwater monitoring may influence the TOCO baseline in virtue of water temperature and depth or other reasons. Please adjust the TOCO baseline until the pressure of the transducer in water is steady and keep checking it.
  • Page 62 F9, F9 Express Fetal & Maternal Monitor User Manual Introducing the FTS-3 Fetal Telemetry System  The fetal monitor screen has no display. 9. Install the TOCO-T or TOCO-E transducer to charge:  The TOCO-T or TOCO-E transducer screen displays charging interface and charging state.

  • Page 63: Chapter 4 Alarms

    F9, F9 Express Fetal & Maternal Monitor User Manual Alarms Chapter 4 Alarms WARNING A potential hazard can exist if different alarm presets are used for the same or similar equipment in any single area. 4.1 Alarm Classification The monitor has two types of alarm: patient alarm and technical alarm.

  • Page 64: Visual Alarm

    F9, F9 Express Fetal & Maternal Monitor User Manual Alarms is enabled again only when the SILENCE key is pressed. If Alarm Reset is enabled (see 4.8 Pausing or Resetting the Alarm), and you press the SILENCE key to disable an audible alarm, the alarm indicator will display , which is flashing in the manner of lighting for one second and pausing for one second.

  • Page 65: Choosing The Alarm Display Form

    F9, F9 Express Fetal & Maternal Monitor User Manual Alarms alarm event; the first number is the current measurement result; the second number is the preset alarm limit. The technical alarm messages are displayed in text form, for example “Fetus EQUIP MALF”.

  • Page 66: Choosing Signal Loss Delay

    F9, F9 Express Fetal & Maternal Monitor User Manual Alarms 4.7 Choosing Signal Loss Delay When the fetal signal is lost and this condition continues for a certain time, the monitor issues a technical alarm. This time (signal loss delay) is adjustable. To change the signal loss delay, Select the setup key on the main interface.

  • Page 67: Alarm Treatment Measures

    F9, F9 Express Fetal & Maternal Monitor User Manual Alarms information, but also record the historically physiological alarm, signal overlap alarm and US1, US2 signal loss alarm messages with date and time information. The monitor can display a maximum of 100 immediate alarm messages. When the storage is full, it will delete the earliest alarm message automatically to store the new one.

  • Page 68: Testing Alarms

    F9, F9 Express Fetal & Maternal Monitor User Manual Alarms emergency occurs. When the monitor gives out an alarm and catches your attention, you should: - Check the patient‟s condition. - Identify the cause of the alarm. - Silence the alarm if necessary.
  • Page 69 F9, F9 Express Fetal & Maternal Monitor User Manual Alarms FHR1/FHR2 Alarm On, Off FHR1/FHR2 Low Alarm Limit 60 bpm ~ 205 bpm, in increments of 5 110 bpm FHR1/FHR2 High Alarm Limit 65 bpm ~ 210 bpm, in increments of 5...

  • Page 70: Alarm Messages

    F9, F9 Express Fetal & Maternal Monitor User Manual Alarms 21 mmHg ~ 235 mmHg, in increments of 1 110 mmHg MAP High Alarm Limit (2.8 kPa ~31.3 kPa, in increments of 0.1) (14.8 kPa) MAP Alarm Delay 0 second, not adjustable...
  • Page 71 F9, F9 Express Fetal & Maternal Monitor User Manual Alarms Medium Level The battery power is too low to Connect the monitor to AC **Battery Low Monitor support further work of the power supply. monitor. Low Level There is no paper in the paper...

  • Page 72: Maternal Monitoring Alarm Messages

    Disconnection (ETHERNET network) monitor 4.14.2 Maternal Monitoring Alarm Messages Besides the fetal monitoring alarms, F9 Express also gives alarms for the situations that occur during maternal monitoring. The alarm messages are listed below. Patient Alarm Messages Alarm Message Source...
  • Page 73 F9, F9 Express Fetal & Maternal Monitor User Manual Alarms **TEMP LOW or TEMP result (xxx) is lower than TEMP the lower limit (yyy). **TEMP xxx < yyy Technical Alarm Messages Alarm Message Source Cause Countermeasure High Level Check the connection of the...
  • Page 74 F9, F9 Express Fetal & Maternal Monitor User Manual Alarms Measure again, failure persists, stop using NIBP OVER The pressure has exceeded the NIBP monitor for NIBP measuring PRESSURE specified upper safety limit. and contact the manufacturer for service. A different cuff other than the one...

  • Page 75: Technical Alarm Messages

    Alarms 4.14.3 FTS-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 76 F9, F9 Express Fetal & Maternal Monitor User Manual Alarms switch, SpO2 high/low alarm limit, SpO2 alarm switch, SYS high/low alarm limit, SYS alarm switch, DIA high/low alarm limit, DIA alarm switch, MAP high/low alarm limit, MAP alarm switch, TEMP high/low alarm limit, TEMP alarm switch.

  • Page 77: Chapter 5 Printing

    F9, F9 Express 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 synchronously monitoring traces: FHR1/FHR2/TOCO/AFM/HR/ SpO traces;...

  • Page 78: Printing Configuration

    F9, F9 Express Fetal & Maternal Monitor User Manual Printing NOTE: The paper advancing key is invalid in the process of printing and paper advancing. 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.

  • Page 79: Switching Print Self-Check On Or Off

    F9, F9 Express Fetal & Maternal Monitor User Manual Printing Select OK. 5.2.4 Switching Print Self-Check On or Off You can choose to switch print self-check on or off: Select the setup key on the main interface. Select Recorder > Print Self-Check.

  • Page 80: Understanding Recorder Paper Printout

    The paper settings of the monitor. It consists of the paper type and paper style, e.g. “G 50-210”, indicating that the paper type is “F9-G”, Paper Settings and the paper style is International. It is printed out to check if the proper recorder paper is used.
  • Page 81 F9, F9 Express Fetal & Maternal Monitor User Manual Printing A list of current date, time, print speed, ID, Name, FHR2 offset, HR, Trace and TEMP is printed at the start of the monitoring and every 10 Information List minutes/20 minutes/30 minutes/ 60 minutes(optional) afterwards.

  • Page 82: Chapter 6 Pre-Monitoring Preparation

    F9, F9 Express Fetal & Maternal Monitor User Manual Pre-Monitoring Preparation Chapter 6 Pre-Monitoring Preparation 6.1 Loading Recorder paper WARNING 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.
  • Page 83 F9, F9 Express Fetal & Maternal Monitor User Manual Pre-Monitoring Preparation 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).

  • Page 84: Switching On The Monitor

    Check if the paper settings match the paper being used (in the circled area below, P should correspond to F9-P, and G to F9-G), and then observe the starts and ends of the printed baselines (illustrated with the arrow). The starts and ends should be printed exactly on the edges of the pane if the recorder paper is correctly loaded and set.

  • Page 85: Adjusting The Screen Angle

    F9, F9 Express 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.

  • Page 86: Setting Date And Time

    F9, F9 Express 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.

  • Page 87: Connecting Transducers

    F9, F9 Express Fetal & Maternal Monitor User Manual Pre-Monitoring Preparation 6.6 Connecting Transducers Check for visible damages of the transducers every time before connecting them to the monitor. Pay special attention to the cracks on the transducers and cables before immersing them into conductive fluid.

  • Page 88: Adjusting The Volume

    F9, F9 Express 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.
  • Page 89 F9, F9 Express Fetal & Maternal Monitor User Manual Pre-Monitoring Preparation 1 Select the volume adjustment key on the main interface. 2 Rotate the control knob clockwise or touch the symbol for one step, the volume increases by one level, there are ten levels in all; the green pane of the volume level indicator increases by one at every two steps;...

  • Page 90: Chapter 7 Fetal Monitoring

    F9, F9 Express 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 this monitor during electro-surgery or MRI; otherwise it might result in harming the patient or the operator.

  • Page 91: Monitoring Fhr With Wired Ultrasound Transducer

    F9, F9 Express Fetal & Maternal Monitor User Manual Fetal Monitoring WARNING If FHR reduces more than 10 bpm suddenly, or the beat of fetal heart sounds slower abruptly, please check if it is the MHR that is being monitored by the transducer. If so, relocate the transducer for the best fetal heart signal.
  • Page 92 You can perform either of the following:  Measure the maternal heart rate with ECG or SpO2 synchronously (available on F9 Express monitor). The monitor‟s SOV function can issue an alarm when the FHR signal source is likely to be from the maternal heart.

  • Page 93: Monitoring Fhr With Wireless Ultrasound Transducer

    F9, F9 Express Fetal & Maternal Monitor User Manual Fetal Monitoring If the maternal heart signal is misidentified as the fetal heart signal, Repositioning of the transducer is needed. NOTE: Do not mistake the high maternal heart rate for fetal heart rate. The fetal pulse can be distinguished from the maternal pulse by feeling the mother’s pulse during the...

  • Page 94: Changing The Fhr Alarm Limits

    F9, F9 Express Fetal & Maternal Monitor User Manual Fetal Monitoring monitor will no longer give any audible or visual warning for this monitoring item. Select the setup key on the main interface. Select Alarm. On the displayed Password box, enter 9999, then select Enter.

  • Page 95: Testing Us Transducers

    F9, F9 Express Fetal & Maternal Monitor User Manual Fetal Monitoring Select a value from 0 ~ 300 second(s) for High Alarm Delay. (The step is 5, and the default value is 10 seconds.) Select a value from 0 ~ 300 second(s) for Low Alarm Delay. (The step is 5, and the default value is 10 seconds.)

  • Page 96: Monitoring Fhr With Decg

    F9, F9 Express 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 97: Wired Decg Monitoring

    F9, F9 Express Fetal & Maternal Monitor User Manual Fetal Monitoring is well attached to the fetus. Release the electrode wires from the handle notch and straighten them. Slide the drive and guide tubes off the electrode wires. Insert the safety cap into DECG cable.

  • Page 98: Wireless Decg Monitoring

    F9, F9 Express Fetal & Maternal Monitor User Manual Fetal Monitoring section 7.3.3 Directions for Using Fetal Spiral Electrode. Fix an attachment pad electrode to DECG cable. Remove the film on the back of the electrode and place the electrode on maternal thigh; press it firmly in place.

  • Page 99: Changing Decg Beep Volume

    F9, F9 Express Fetal & Maternal Monitor User Manual Fetal Monitoring The following illustration shows how these parts should be connected: Figure 7-5 Connection for wireless DECG Monitoring 7.3.5.2 Monitoring Procedure Connect the FTS-3 system to the monitor and switch on. Refer to section 3.2.7 connecting to the Monitor.

  • Page 100: Decg Gain And Display

    F9, F9 Express Fetal & Maternal Monitor User Manual Fetal Monitoring NOTE: The DECG beep and HR beep share the same audio channel. Once the DECG beep is switched on, the HR beep is disabled (set to OFF) automatically. Once the DECG/HR beep volume is changed, the sound switches to channel 1 automatically.

  • Page 101: Monitoring Twin Fhrs

    F9, F9 Express Fetal & Maternal Monitor User Manual Fetal Monitoring 7.4 Monitoring Twin FHRs 7.4.1 Monitoring Twins Externally To monitor twin FHRs externally, you need to connect a US transducer to US1 socket and the second US transducer to US2 socket of the monitor. Follow the instructions described in Section 7.2 Monitoring FHR with Ultrasound to acquire FHR signals for both channels.

  • Page 102: Monitoring Uterine Activity Externally

    F9, F9 Express Fetal & Maternal Monitor User Manual Fetal Monitoring To change the FHR2 offset, Select the setup key on the main interface. Select Recorder > FHR2 Offset. Select -20 bpm (default), 0 bpm or +20bpm. Select OK. This preset FHR2 offset will be printed on the recorder paper every 10 minutes（Default）...

  • Page 103: Wireless Toco Monitoring

    F9, F9 Express Fetal & Maternal Monitor User Manual Fetal Monitoring position should be different for different purposes: place the transducer close to the fetal buttocks for NST, and place it on fetal back in delivery. Place the transducer Place the transducer...

  • Page 104: Changing The Ua Baseline

    F9, F9 Express Fetal & Maternal Monitor User Manual Fetal Monitoring 7.5.3 Changing the UA Baseline You can change the UA baseline, Select the setup key on the main interface. Select Fetus > UA Baseline. Select 5, 10 (default), 15 or 20.

  • Page 105: Monitoring Uterine Activity Internally

    F9, F9 Express Fetal & Maternal Monitor User Manual Fetal Monitoring 7.6 Monitoring Uterine Activity Internally 7.6.1 Parts Required ™ Disposable intrauterine pressure catheter ACCU-TRACE IUPC (“IUPC” for short) Reusable intrauterine pressure cable (“IUP cable” for short) Reusable intrauterine pressure connecting cable (“connecting cable” for short)
  • Page 106 F9, F9 Express Fetal & Maternal Monitor User Manual Fetal Monitoring completely out of the vagina, slide thumb between catheter and introducer tab, which will begin to separate the introducer from the catheter. Figure 7-9 Separate the Introducer Anchor the catheter in place with one hand, and pull the introducer straight back off the catheter.

  • Page 107: Iup Monitoring Procedure

    F9, F9 Express Fetal & Maternal Monitor User Manual Fetal Monitoring WARNING 1 Before insertion of IUPC, placental position should be confirmed, amniotic membranes are adequately ruptured and sufficient cervical dilatation is assured. 2 Try to insert the catheter opposite the placental site. Do not insert the introducer beyond the cervical OS.

  • Page 108: Checking Intrauterine Pressure Cable Function

    F9, F9 Express Fetal & Maternal Monitor User Manual Fetal Monitoring 7.6.4 Checking Intrauterine Pressure Cable Function To test an IUP cable‟s function: 1) Disconnect the catheter from the cable. Insert the cable check plug into the catheter end of the cable.

  • Page 109: Enabling Or Disabling Afm Monitoring

    F9, F9 Express Fetal & Maternal Monitor User Manual Fetal Monitoring 7.7.2 Enabling or Disabling AFM Monitoring To enable or disable AFM monitoring, Select the setup key on the main interface. Select Fetus > AFM. Select ON or OFF (default).

  • Page 110: Changing Mfm Volume

    F9, F9 Express Fetal & Maternal Monitor User Manual Fetal Monitoring the screen in MFM numeric area. 1) Insert the FM marker connector into the MARK socket on the monitor. 2) Let the patient hold the marker in hand; ask her to press the top key of it when a fetal movement is felt.

  • Page 111: Switching Mat. Info Inputting On Or Off

    F9, F9 Express Fetal & Maternal Monitor User Manual Fetal Monitoring Select ID. Figure 7-16 Soft Keyboard Select the required character for patient‟s ID on the soft keyboard. Select Enter. Select Name. Select the required letter for patient‟s name on the soft keyboard.
  • Page 112 F9, F9 Express Fetal & Maternal Monitor User Manual Fetal Monitoring Select the setup key on the main interface. Select Start Monitoring > Mat. Info. Select ON or OFF (default). Select OK. - 101 -...

  • Page 113: Chapter 8 Fetal Monitoring Display (F9)

    F9, F9 Express Fetal & Maternal Monitor User Manual Fetal Monitoring Display Chapter 8 Fetal Monitoring Display (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 114 F9, F9 Express Fetal & Maternal Monitor User Manual Fetal Monitoring Display The AFM monitoring result is displayed either in the form of a trace or in the form of black marks. AFM trace The x-axis of each wave indicates the duration of a detected fetal movement.

  • Page 115: Changing Time Scale

    F9, F9 Express Fetal & Maternal Monitor User Manual Fetal Monitoring Display NOTE: AFM trace is only for reference. Please take the MFM marks as criterion. TOCO trace The y-axis indicates the numeric of TOCO. The range is 0 ~ 100.

  • Page 116: Data Saving

    F9, F9 Express Fetal & Maternal Monitor User Manual Fetal Monitoring Display 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. The main interface only displays the new patient‟s data. During monitoring, the data is saved every 10 minutes.

  • Page 117: File Management (Optional)

    F9, F9 Express Fetal & Maternal Monitor User Manual Fetal Monitoring Display 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 118 F9, F9 Express Fetal & Maternal Monitor User Manual Fetal Monitoring Display Figure 8-6 File Management 4 If the required record is not on the current page, select Next to view more records. 5 Move the cursor to select the required item, and then select Export in the pop-up item, and the monitor exports this record to the USB disk.

  • Page 119: Reviewing

    F9, F9 Express Fetal & Maternal Monitor User Manual Fetal Monitoring Display damage may be caused. 2 You should unplug the USB disk after performing the Remove Disk procedure; otherwise the monitor cannot identify the USB disk. 8.2.3.3 Deleting Files After the files are saved, you can delete them.

  • Page 120: Ctg Analysis

    F9, F9 Express Fetal & Maternal Monitor User Manual Fetal Monitoring Display X% indicates the proportion of current traces positioned in the whole reviewable traces. Move the cursor away from the trace control tools, or touch any place out of the trace window on the screen to return to the real-time main interface.
  • Page 121 F9, F9 Express Fetal & Maternal Monitor User Manual Fetal Monitoring Display Select OK. A CTG analysis key appears on the main interface, indicating that CTG analysis is enabled. 8.2.5.2 CTG Analyzing NOTE: 1 CTG analyze starts after the real-time trace has been printed for 10 minutes.

  • Page 122: Marking A Note

    F9, F9 Express Fetal & Maternal Monitor User Manual Fetal Monitoring Display 15 seconds. DECELERATIONS: the deceleration time. SHORT TERM the short-term variation analysis result. VARIATION: LONG TERM the long-term variation analysis result. VARIATION: ANALYSIS START: the start time of the analysis.

  • Page 123: Numerics

    F9, F9 Express Fetal & Maternal Monitor User Manual Fetal Monitoring Display 8.2.6.3 Changing smart note content You can change the smart note content in the smart note list by performing the following steps: Select the setup key on the main interface.

  • Page 124: Changing Numeric Window Position (F9)

    TOCO-T transducer or TOCO-E transducer are displayed in the numeric window. 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, Select the setup key on the main interface.

  • Page 125: Chapter 9 Maternal Monitoring (F9 Express)

    F9, F9 Express Fetal & Maternal Monitor User Manual Maternal Monitoring Chapter 9 Maternal Monitoring (F9 Express) WARNING 1 Do not apply this monitor during electro-surgery or MRI; otherwise it might result in harming the patient or the operator. 2 Always check if the alarm settings are appropriate for your patient before starting monitoring.

  • Page 126: How To Place 3-Lead Ecg Cables

    F9, F9 Express 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 127: How To Place 2-Lead Fts-3 Mecg Cables

    F9, F9 Express 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 attachment of electrodes, if so, change for new electrodes or change their sites every 24 hours.
  • Page 128 F9, F9 Express Fetal & Maternal Monitor User Manual Maternal Monitoring L (LA) Yellow (Black) R (RA) Red (White) Figure 9-3 Placing 2-lead FTS-3 MECG Cable(1) If the signal is not good, please try below position. Position Name Color Name...

  • Page 129: Wired Ecg Monitoring

    F9, F9 Express Fetal & Maternal Monitor User Manual Maternal Monitoring 9.1.4 Wired ECG Monitoring 9.1.4.1 Parts Required a) 3-lead ECG cable b) Attachment pad electrodes Note: The filter of AC power supply can be configured by selecting System>Factory Configuration>Line Frequency>50(default) or 60. Please select it according to the current AC frequency.

  • Page 130: Changing Ecg Source

    F9, F9 Express Fetal & Maternal Monitor User Manual Maternal Monitoring WARNING The electrodes for wireless MECG cable should be placed on flat and smooth positions right in the middle of the first intercostals space. Please check the contact of the electrodes regularly.

  • Page 131: Maternal Spo Monitoring

    F9, F9 Express Fetal & Maternal Monitor User Manual Maternal Monitoring Select the setup key on the main interface. Select Mother > ECG Calibration. Select Calibration or OFF (default). Select OK. The monitor creates a square wave in the ECG area. Compare the square wave with the ECG gauge.
  • Page 132 The F9 Express monitor is compatible with the SpO transducers supplied by EDAN only. The transducer manufactured by EDAN can only be used with the F9 Express monitor. Compatibility should be checked prior to use. Otherwise the monitor performance can be degraded.
  • Page 133 F9 and F9 Express Fetal & Maternal Monitor User Manual Maternal Monitoring WARNING 6 Setting the SpO higher alarm limit to 100% is equivalent to switching off the alarm on higher limit. High oxygen levels may predispose a premature infant to retrolental fibroplasia.

  • Page 134: Spo Monitoring Procedure

    F9 and F9 Express Fetal & Maternal Monitor User Manual Maternal Monitoring 10) External illumination more than 5,000 lumens/square meter (typical office lighting). (Cover the sensor site with opaque materials is recommended.) 11) Venous pulsations. To use the sensor: a) Select an appropriate sensor. Use the SpO transducers approved by the manufacturer.

  • Page 135: Assessing The Validity Of A Spo2 Reading

    F9 and F9 Express Fetal & Maternal Monitor User Manual Maternal Monitoring Select the setup key on the main interface. Select Recorder > SpO Trace. Select ON or OFF (default). Select OK. 9.2.4 Assessing the Validity of a SpO2 Reading...

  • Page 136: Switching The Spo 2 Alarm On Or Off

    F9 and F9 Express Fetal & Maternal Monitor User Manual Maternal Monitoring 9.2.6 Switching the SpO Alarm On or Off You can choose to switch the SpO alarm on or off. Select the setup key on the main interface. Select Alarm. On the displayed Password box, enter 9999, then select Enter.

  • Page 137: Changing Hr Beep Volume

    F9 and F9 Express Fetal & Maternal Monitor User Manual Maternal Monitoring Select Mother > HR Source. Select ECG (default) or Pulse (during SpO monitoring). Select OK. 9.3.3 Changing HR Beep Volume When the HR beep is enabled, the monitor gives a beep sound of maternal heart. The frequency of HR beep corresponds to the maternal heart rate, but occasionally it may differ due to weak HR signal.

  • Page 138: Changing Hr Alarm Limits

    F9 and F9 Express Fetal & Maternal Monitor User Manual Maternal Monitoring Select HR. Select ON (default) or OFF for Alarm. Select OK. 9.3.6 Changing HR Alarm Limits You can change the HR alarm limits. Select the setup key on the main interface.
  • Page 139 F9 and F9 Express Fetal & Maternal Monitor User Manual Maternal Monitoring and pulse rate (PR) (optional) are measured and displayed. The blood pressure measurements determined with this device comply with the American National Standard for Electronic or Automated Sphygmomanometers (ANSI/AAMI/ISO 81060-2:2013) in relation to mean error and standard deviation.

  • Page 140: How To Apply Nibp Cuff

    F9 and F9 Express Fetal & Maternal Monitor User Manual Maternal Monitoring 2) Cardiac Arrhythmia Measurements will be unreliable and may not be possible if the patient's cardiac arrhythmia has caused an irregular heartbeat. The measuring time thus will be prolonged.

  • Page 141: Preparation For Nibp Monitoring

    F9 and F9 Express Fetal & Maternal Monitor User Manual Maternal Monitoring Figure 9-6: Applying the Cuff 9.4.3 Preparation for NIBP Monitoring To obtain accurate measurements, the following operating steps need to be observed: 1. Ensure the patient position in normal use, including ...

  • Page 142: Auto Measurement

    F9 and F9 Express Fetal & Maternal Monitor User Manual Maternal Monitoring 4) Connect the cuff to the air hose. The limb chosen for taking the measurement should be placed at the same level as the patient's heart. If this is not possible, correct the measurement using the formula described in section 9.4.6 Correcting the Measurement.

  • Page 143: Correcting The Measurement

    F9 and F9 Express Fetal & Maternal Monitor User Manual Maternal Monitoring Select the setup key on the main interface. Select Mother > Cycle. Select Manual. Select OK. Press NIBP key on the front panel to start a manual measurement.

  • Page 144: Switching The Nibp Alarm On Or Off

    F9 and F9 Express Fetal & Maternal Monitor User Manual Maternal Monitoring Select OK. Note： When the network version is ETHERNET 1.4，if the fetal monitor gets on line, the central station will control to make the NIBP unit of the fetal monitor in concert with that of the central station.

  • Page 145: Changing Map Alarm Limits

    F9 and F9 Express Fetal & Maternal Monitor User Manual Maternal Monitoring Select a value from 11 ~ 215 (mmHg) or 1.4~28.7(kPa) for High Alarm Limit. (If the unit is mmHg, the step is 1, and the default value is 90 mmHg; if the unit is kPa, the step is 0.1, and the default value is 12.0 kPa.)

  • Page 146: Maternal Temp Monitoring

    F9 and F9 Express Fetal & Maternal Monitor User Manual Maternal Monitoring 9.5 Maternal TEMP Monitoring 9.5.1 TEMP Monitoring Procedure 1) Insert the TEMP plug into the TEMP socket on the monitor. 2) Apply the sensor firmly underneath the patient‟s axilla. It takes 5 minutes for the temperature measurement to stabilize.

  • Page 147: Switching The Temp Alarm On Or Off

    F9 and F9 Express Fetal & Maternal Monitor User Manual Maternal Monitoring Select º C (default) or º F. Select OK. Note： When the network version is ETHERNET 1.4，if the fetal monitor gets on line, the central station will control to make the TEMP unit of the fetal monitor in concert with that of the central station.

  • Page 148: Chapter 10 Maternal Monitoring Display (F9 Express)

    Chapter 10 Maternal Monitoring Display (F9 Express) 10.1 *Display Mode F9 Express has 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. The display mode will switch among the three modes.
  • Page 149 F9, F9 Express Fetal & Maternal Monitor User Manual Maternal Monitoring Display Figure 10-2 Fetal Display Mode - 138 -...
  • Page 150 F9, F9 Express Fetal & Maternal Monitor User Manual Maternal Monitoring Display Figure 10-3 Maternal Display Mode - 139 -...

  • Page 151: Maternal Monitoring Traces

    The maternal monitoring traces include ECG waveform and SpO waveform. The fetal monitoring traces are the same as traces of F9, refer to 8.1 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 152: Numerics

    The numeric list can be reviewed: select the list, press the symbol or rotate the control knob to review the previous lists. 10.4 Numerics Besides the fetal numerics, the numeric window of F9 Express includes maternal vital signs: , NIBP, HR and TEMP: - 141 -...
  • Page 153 F9, F9 Express Fetal & Maternal Monitor User Manual Maternal Monitoring Display FHR1 FHR2 TOCO NIBP TEMP Figure 10-7 Maternal Numeric Window 99: Current SpO measurement numeric. 100: SpO alarm upper limit 90: SpO alarm lower limit : SpO indicator.
  • Page 154 F9, F9 Express Fetal & Maternal Monitor User Manual Maternal Monitoring Display TEMP (º C): TEMP unit. When F9 Express Fetal/Maternal Monitor is connected to FTS-3 Telemetry System, the signal strength and signal quality icon and battery level icon of the US-T transducers and TOCO-T transducer or TOCO-E transducer are displayed in the numeric window.
  • Page 155 F9, F9 Express Fetal & Maternal Monitor User Manual Maternal Monitoring Display Figure 10-9 - 144 -...

  • Page 156: Chapter 11 After Monitoring

    F9, F9 Express Fetal & Maternal Monitor User Manual After Monitoring Chapter 11 After Monitoring 11.1 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.

  • Page 157: Chapter 12 Maintenance And Cleaning

    F9, F9 Express Fetal & Maternal Monitor User Manual Maintenance and Cleaning Chapter 12 Maintenance and Cleaning 12.1 Maintenance 12.1.1 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 158: Maintenance Of Monitor And Base Station

    F9, F9 Express Fetal & Maternal Monitor User Manual Maintenance and Cleaning CAUTION Besides the maintenance requirements recommended in this manual, comply with local regulations on maintenance and measurement. 12.1.2 Maintenance of Monitor and Base Station Keep the exterior surface of the monitor and the base station clean, free of dust and dirt.

  • Page 159: Cleaning Of Recorder

    F9, F9 Express Fetal & Maternal Monitor User Manual Maintenance and Cleaning Storage conditions outside these limits may distort the paper and adversely affect the accuracy of grid lines or make the trace unreadable. 12.1.5 Cleaning of Recorder The recorder platen, thermal print head and paper sensing mechanism must be cleaned at least once a year or when needed (when traces become faint).

  • Page 160: Cleaning Of Accessories

    F9, F9 Express Fetal & Maternal Monitor User Manual Maintenance and Cleaning WARNING 1 Unplug the monitor and the base station from the AC power source and detach all accessories before cleaning. Do not immerse the unit in water or allow liquids to enter the case.
  • Page 161 F9, F9 Express Fetal & Maternal Monitor User Manual Maintenance and Cleaning 3) Air-dry them or wipe the remaining moisture with a soft dry cloth. The recommended cleansers for accessories are listed below: Accessory Cleansers Ultrasound Transducer TOCO Transducer Mild near neutral detergent Ethanol 75% Isopropanol 70%...

  • Page 162: Disinfecting

    F9, F9 Express Fetal & Maternal Monitor User Manual Maintenance and Cleaning Figure 12-1 Replace the Rubber Bag in the Cuff 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 163: Sterilizing

    F9, F9 Express Fetal & Maternal Monitor User Manual Maintenance and Cleaning Type Recommended NIBP Cuff Ethanol 75% Isopropanol 70% NIBP Cuff Extension Tube 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.

  • Page 164: Chapter 13 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 165: Appendix 1 Product Specifications

    F9, F9 Express Fetal & Maternal Monitor User Manual Product Specifications Appendix 1 Product Specifications A F9, F9 Express Fetal/Maternal Monitor A1.1 Environmental Specifications The monitor may not meet the performance specifications given here if stored or used outside the specified temperature and humidity ranges.
  • Page 166 F9, F9 Express Fetal & Maternal Monitor User Manual Product Specifications FHR1, FHR2, TOCO, FM, IUP , NIBP BF (Defibrillating-proof) Anti-electric Shock Degree DECG ECG, TEMP CF (Defibrillating-proof) Main Unit: IPX1, protected against vertically falling water drops (provided recorder drawer is shut and the monitor is...

  • Page 167: A1.3 Performance Specifications

    F9, F9 Express Fetal & Maternal Monitor User Manual Product Specifications Cable Length Weight 213 g SpO2 Cable Length 2.4 m Weight 68 g NIBP Cable Length 3.3 m Weight 194 g TEMP Cable Length Weight 55 g A1.3 Performance Specifications...
  • Page 168 F9, F9 Express Fetal & Maternal Monitor User Manual Product Specifications ±10% Non-linear Error Resolution 1 unit/min/° C (free air) Baseline Drift Temperature Changes 5 units/min/° C (underwater) Automatic (TOCO value becomes zero or below Zero Mode lasting for 30 seconds)/ Manual...
  • Page 169 F9, F9 Express Fetal & Maternal Monitor User Manual Product Specifications MHR Measuring Accuracy ±2bpm 1 bpm Resolution 30bpm ~ 240bpm MHR Alarm Limits HR Alarm Alarm Defibrillating-proof Anti-electric Shock Type ±8 mV PP Input Signal Range ECG Waveform Manual control ECG waveform display...
  • Page 170 F9, F9 Express Fetal & Maternal Monitor User Manual Product Specifications Range: 7s ~ 8s (average: 7.5s) MHR range: 80bpm ~ 40bpm Range : 7s ~ 8s (average: 7.5s) Exceeds ANSI/AAMI EC13-2002 Sect. 3.1.2.1 Tall T-wave Rejection minimum recommended 1.2mV T-Wave...
  • Page 171 F9, F9 Express Fetal & Maternal Monitor User Manual Product Specifications kPa~28.7 kPa) Mean Artery Pressure: 20 mmHg ~ 235 mmHg (2.7 kPa~31.3 kPa) 1 mmHg (0.1 kPa) Resolution ≤ 5mmHg (≤ 0.8 Max. average deviation kPa) Measuring Accuracy Max. standard deviation ≤ 8mmHg (≤1.2 kPa)

  • Page 172: A1.4 Recorder Specifications

    F9, F9 Express Fetal & Maternal Monitor User Manual Product Specifications Position Axilla Accessory TEMP transducer NOTE: The essential performance is marked with an asterisk *. A1.4 Recorder Specifications Z-fold, thermosensitive Paper (compatible with GE and PHILIPS recorder papers) Paper width...

  • Page 173: A1.5 Rechargeable Lithium-Ion Battery

    F9, F9 Express Fetal & Maternal Monitor User Manual Product Specifications A1.5 Rechargeable Lithium-ion Battery Type Rechargeable Lithium-ion Battery Continual Working Time >2 hours Necessary charge time from "out of power" to <7hours "fully charged" Necessary charge time from "out of power" to <5 hours...

  • Page 174: B Fts-3 Fetal Telemetry System

    F9, F9 Express Fetal & Maternal Monitor User Manual Product Specifications B FTS-3 Fetal Telemetry System B1.1 Environmental Specifications Temperature +5 º C ~ +40 º C (+41º F ~ +104º F) Working Relative Humidity 15% ~ 93% (non-condensing) 86 kPa ~ 106 kPa...
  • Page 175 F9, F9 Express Fetal & Maternal Monitor User Manual Product Specifications Leakage Current N.C. S.F.C. Ground Leakage Current (Limit) 500µA 1000µA N.C. S.F.C. Enclosure Leakage Current (Limit) 100µA 500µA N.C. S.F.C. Patient Leakage Current (Limit) d.c. 10µA 50µA FHR1, FHR2, TOCO a.c.

  • Page 176: B1.3 Performance Specifications

    F9, F9 Express Fetal & Maternal Monitor User Manual Product Specifications B1.3 Performance Specifications Ultrasound 50 bpm ～ 240 bpm Measurement Range 1 bpm Resolution ± 2 bpm Accuracy Technique Ultrasound Pulse Doppler with autocorrelation 2 kHz Pulse Repetition Rate Pulse Duration 92 µs...
  • Page 177 F9, F9 Express Fetal & Maternal Monitor User Manual Product Specifications >110m (when performing underwater monitoring using US-T and Transmission Range ≤ TOCO-T transducers, keep the transducer at a distance 30cm from (Without Obstacles) ≤ the water surface and a distance 8m from the base station.)
  • Page 178 F9, F9 Express Fetal & Maternal Monitor User Manual Product Specifications N.C. S.F.C. Patient Auxiliary Current d.c. 10µA 50µA (Limit) a.c. 10µA 50µA Differential Input >5MΩ Impedance Electrode Offset Potential ± 500mV Tolerance Active electrode: < 100 nA Auxiliary Current (Leads...

  • Page 179: B1.4 Rechargeable Lithium-Ion Battery

    F9, F9 Express Fetal & Maternal Monitor User Manual Product Specifications B1.4 Rechargeable Lithium-ion Battery Base Station Battery 5000 mAh Nominal Capacity Continuous Work Time ≥40 Hours 14.8 V Nominal Voltage Necessary Charge ≤14 Hours Time >300 times Cycle Life...
  • Page 180 F9, F9 Express Fetal & Maternal Monitor User Manual Product Specifications Low Output Summary Table (for systems with no transducers having global maximum index values exceeding 1.0) System: Fetal Telemetry System Transducer: 7-Crystal Wafer Ipa.3@MI spta.3 Transducer Model TI Type...

  • Page 181: Appendix 2 Signal Input/ Output Connector

    F9, F9 Express 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 182 F9, F9 Express 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 or telemetry system recommended by the manufacturer can be connected to the signal input/output interface of the monitor. Other equipment is forbidden.

  • Page 183: Appendix 3 Troubleshooting

    F9, F9 Express Fetal & Maternal Monitor User Manual Troubleshooting Appendix 3 Troubleshooting A F9, F9 Express Fetal/Maternal Monitor A3.1 No Display Phenomenon Possible Cause Solution Power cable is loose. Tighten the power cable. Power indicator is off. The fuse is blown.

  • Page 184: A3.4 Trouble With Ultrasound Fhr Monitoring

    F9, F9 Express 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.

  • Page 185: A3.6 Troubles With Contractions Monitoring (External)

    F9, F9 Express Fetal & Maternal Monitor User Manual Troubleshooting A3.6 Troubles with Contractions Monitoring (External) Phenomenon Possible Cause Solution The belt is too tight or too loose. Adjust the belt. The belt has no elasticity. Renew the belt. trace...

  • Page 186: A3.9 Nibp And Spo2 No Results

    F9, F9 Express Fetal & Maternal Monitor User Manual Troubleshooting special ground wire Check if the special ground wire connecting with monitor is not connecting with monitor properly earthed. earthed. A3.9 NIBP and SpO2 No Results Phenomenon Possible Cause Solution...
  • Page 187 F9, F9 Express Fetal & Maternal Monitor User Manual Troubleshooting - 176 -...

  • Page 188: B Fts-3 Fetal Telemetry System

    F9, F9 Express Fetal & Maternal Monitor User Manual Troubleshooting B FTS-3 Fetal Telemetry System B3.1 Troubleshooting Phenomenon Possible Cause Solution ① Recharge the transducer. ① It runs out of power. Take US-T ② Put it back in the docking ②...
  • Page 189 F9, F9 Express Fetal & Maternal Monitor User Manual Troubleshooting 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.
  • Page 190 F9, F9 Express Fetal & Maternal Monitor User Manual Troubleshooting 5) Push the fuse container all the way back in position. - 179 -...

  • Page 191: Appendix 4 Ultrasound Intensity And Safety

    F9, F9 Express 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 192: A4.3.2 Ti (Thermal Index)

    F9, F9 Express Fetal & Maternal Monitor User Manual Ultrasound Intensity and Safety MI = r, α × 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.

  • Page 193: A4.4 Prudent Use Statement

    F9, F9 Express Fetal & Maternal Monitor User Manual Ultrasound Intensity and Safety 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 194: A4.6 Transducer Acoustic Output Parameters List

    F9, F9 Express Fetal & Maternal Monitor User Manual Ultrasound Intensity and Safety A4.6 Transducer Acoustic Output Parameters List A4.6.1 Test of Wired Transducer Acoustic output reporting table for IEC60601-2-37 (IEC60601-2-37, Edition 2.1, 2015-06, table 201.103) Operating Mode: PW mode Working Frequency: 1.0MHz...

  • Page 195: A4.6.2 Test Of Wireless Transducer (Fts-3)

    F9, F9 Express Fetal & Maternal Monitor User Manual Ultrasound Intensity and Safety dimensions (cm) 0.70 0.70 (usec) 89.72 89.72 (Hz) 2000.00 2000.00 Φ3.46 (cm) Φ3.46 (cm) Focus(mm) Fixed Operating Control Fixed Depth(mm) Conditions 1.00 Frequency(MHz) A4.6.2 Test of Wireless Transducer (FTS-3) A4.6.2.1 12-Crystal Wafer Transducer...
  • Page 196 F9, F9 Express 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 0.017 1.66 0.0092 (MPa) 0.017 (mW) 9.69 9.69 (MHz) 1.00 1.00 1.00...
  • Page 197 F9, F9 Express Fetal & Maternal Monitor User Manual Ultrasound Intensity and Safety at z (MPa) 0.030 Operating Focus(mm) Fixed control Depth(mm) Fixed conditions Frequency(MHz) 1.00 Operating Mode: PW mode Working Frequency: 1.0MHz SPTA.3 SPPA.3 Acoustic Output (mW/cm (W/cm Global Maximum Value 0.030...

  • Page 198: A4.6.3 Standard Parameter Equal Contrast List

    F9, F9 Express Fetal & Maternal Monitor User Manual Ultrasound Intensity and Safety A4.6.3 Standard Parameter Equal Contrast List IEC60601-2-37 standard parameter equal contrast list IEC60601-2-37 parameter NOTE Attenuated Peak-rare-factional Acoustic Pressure r.α Peak-rare-factional Acoustic Pressure Output Power Depth for Soft Tissue Thermal Index Attenuated Output Power α...
  • Page 199 F9, F9 Express Fetal & Maternal Monitor User Manual Ultrasound Intensity and Safety parameter specified in TRACK1 of FDA Guidance TRACK1 parameter NOTE Derated Peak-rare-factional Acoustic Pressure Output Power , Depth for Bone Thermal Index Center Frequency, Acoustic -6dB Beamwidth...

  • Page 200: Appendix 5 Abbreviation

    F9, F9 Express 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...
  • Page 201 F9, F9 Express Fetal & Maternal Monitor User Manual Abbreviation Short-Term Variation Systolic Blood Pressure TEMP Temperature TOCO Tocotonometer Uterine Activity [TOCO/IUP] Ultrasound [Transducer] - 190 -...

  • Page 202: Appendix 6 Ordering Information

    F9, F9 Express Fetal & Maternal Monitor User Manual Ordering Information Appendix 6 Ordering Information Accessories (standard and optional configuration) supplied or approved by the manufacturer can be used with the monitors. See the following table for details. Part Number...
  • Page 203 T2AH250V 01.13.036770 Signal Cable USB TO DB9 01.13.20096 Signal Cable Downloading cable/ Ethernet F9 to OB TraceVue cable (DB9 to RJ45, For OB 01.13.036124 Signal Cable TraceVue with adapter) 01.13.107974 Signal Cable F9 to OB TraceVue cable (DB9 to RJ45) 01.13.107702...
  • Page 204 F9, F9 Express Fetal & Maternal Monitor User Manual Ordering Information 02.01.210061 Wall-Mounting Bracket Provided with F9/ With basket 01.56.465631 Carry Bag Quick Reference User Manual Service Manual Fetal Heart Monitoring Guidance The accessories employed by the manufacturer, such as the rechargeable battery, are products having passed the authentication of CE, and they have the characteristics specified by their manufacturers.

  • Page 205: Appendix 7 Emc Information

    The F9 and F9 Express Fetal & Maternal Monitors are intended for use in the electromagnetic environment specified below. The customer of the user of the F9 and F9 Express Fetal & Maternal Monitors should assure that it is used in such and environment.

  • Page 206: A7.2 Electromagnetic Immunity

    A7.2 Electromagnetic Immunity Guidance and manufacture’s declaration – electromagnetic immunity The F9 and F9 Express Fetal & Maternal Monitors are intended for use in the electromagnetic environment specified below. The customer or the user of F9 and F9 Express Fetal & Maternal Monitors should assure that it is used in such an environment.
  • Page 207 F9, F9 Express Fetal & Maternal Monitor User Manual EMC Information Mains power quality should be 0 % U 0,5 cycle 0 % U 0,5 cycle that of a typical commercial or At 0° , 45° , 90° , 135° , At 0°...

  • Page 208: A7.3 Electromagnetic Immunity

    The F9 and F9 Express Fetal & Maternal Monitors are intended for use in the electromagnetic environment specified below. The customer or the user of F9 and F9 Express Fetal & Maternal Monitors should assure that it is used in such an environment.
  • Page 209 If the measured field strength in the location in which the F9 and F9 Express Fetal & Maternal Monitors are used exceeds the applicable RF compliance level above, the F9 and F9 Express Fetal & Maternal Monitors should be observed to verify normal operation.
  • Page 210 F9, F9 Express Fetal & Maternal Monitor User Manual EMC Information Band 5 1720 GSM 1800; CDMA 1900; Pulse 1845 1700-1990 GSM 1900; modulation DECT; LTE Band 217 Hz 1970 1, 3, 4,25; UMTS Bluetooth, WLAN,802.11 Pulse 2450 2400-2570 b/g/n, RFID...

  • Page 211: A7.4 Recommended Separation Distances

    F9 and F9 Express Fetal & Maternal Monitors The F9 and F9 Express Fetal & Maternal Monitors are intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the F9 and F9 Express Fetal &...

  • Page 212: Appendix 8 Limitations Of Ultrasonic Monitoring

    F9, F9 Express 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 213 F9, F9 Express 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 214: A8.3 Audio Output And Screen Reading

    F9, F9 Express 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.

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