EDAN F9 Service Manual
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EDAN F9 Service Manual

Fetal & maternal monitor
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  • Page 2 Edan Instruments, Inc. (hereinafter called EDAN) can not be held liable. EDAN owns the copyrights of this manual. Without prior written consent of EDAN, any materials contained in this manual shall not be photocopied, reproduced or translated into other languages.
  • Page 3 Using This Label Guide 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. CAUTION A CAUTION label advises against actions or situations that could damage equipment, produce inaccurate data, or invalidate a procedure.

  • Page 4: Table Of Contents

    Table of Contents Chapter 1 Warranty and Service.................... 1 Chapter 2 Overview ......................... 4 2.1 Introduction ........................4 2.2 General Information ...................... 4 2.3 Safety Precautions ......................5 Chapter 3 Installation ......................7 3.1 Environment Requirements................... 7 3.2 Electrical Requirements ....................8 3.3 Safety Requirements .....................
  • Page 5 6.1 Maintenance Inspections ..................... 20 6.2 Maintenance of the Monitor..................20 6.3 Maintenance of the Transducers ................. 21 6.4 Maintenance of the Recorder ..................21 Chapter 7 Principle Introduction ..................22 7.1 Modules Principle ....................... 22 7.1.1 Ultrasound Doppler ................... 22 7.1.2 Fetal movement Doppler Signal Detecting Principle........
  • Page 6 10.1 Tools Required ......................46 10.2 Replacing Fuses......................46 10.3 Disassembling the Main Unit..................47 10.4 Disassembling the Lower assembly ................48 10.4.1 Replacing the FM Module................48 10.4.2 Replacing the DECG Module ................. 49 10.4.3 Replacing the Print Controlling Board............50 10.4.4 Replacing the Printhead ..................

  • Page 7: Chapter 1 Warranty And Service

    Limitation of Warranty Direct, indirect or final damage and delay caused by the following situations for which EDAN is not responsible may void the warranty: Groupware is dismounted, stretched or redebugged.
  • Page 8 After receiving the RMA form from the service department, the customer sends defective parts to EDAN in advance. We will analyze the problems and discuss with the customer about either repairing or replacing the part(s). Once the maintenance fee is invoiced and paid, we will make sure to dispatch good part(s) to the confirmed address.
  • Page 9 F9 Fetal & maternal Monitor Service Manual Warranty and Service NOTE: EDAN should not have any obligation to the end-user or customer who returns the goods without the notification by EDAN’s service department. The sender takes full responsibility for the accounted fee.

  • Page 10: Chapter 2 Overview

    Failure to do so might damage the monitor, invalidate the product warranty or lead to serious personal injury. 2.2 General Information F9 Fetal & maternal Monitor (hereinafter called F9) is designed to comply with the international safety requirements IEC/EN 60601-1 for medical electrical equipment. It is class I equipment.

  • Page 11: Safety Precautions

    WARNING The F9 monitor must be serviced by authorized and qualified personnel only. EDAN 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 12 F9 Fetal & maternal Monitor Service Manual Overview WARNING Accessory equipment connected to the analog and digital 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). Furthermore all configurations shall comply with the valid version of the system standard IEC/EN 60601-1-1.

  • Page 13: Chapter 3 Installation

    F9 Fetal & maternal Monitor Service Manual Installation Chapter 3 Installation WARNING Only qualified service engineers should install this equipment. 3.1 Environment Requirements Working Environment +5 ºC ~ +40 ºC ( +41ºF ~ +104ºF) Temperature: Relative Humidity: 25% ~ 80% (non-condensing)

  • Page 14: Electrical Requirements

    F9 Fetal & maternal Monitor Service Manual Installation 3.2 Electrical Requirements Operating Voltage: 100V-240V ~ Operating Frequency: 50Hz/60Hz Input Power: 110VA 3.3 Safety Requirements SHOCK HAZARD- the power receptacle must be a three-wire grounded outlet. A hospital grade outlet is required. Never adapt the three-prong plug from the monitor to fit a two-slot outlet.

  • Page 15: Mounting The Monitor On A Wall

    F9 Fetal & maternal Monitor Service Manual Installation 3.4.2 Mounting the Monitor on a Wall To mount the monitor on a wall, Order a wall mounting board (MS1R-107983) and a connecting board (MS1R-107984) from the manufacturer. Turn the monitor over and fix the connecting board to the bottom panel using two pan head screws.

  • Page 16: Installing The Monitor On A Roll Stand/Trolley

    F9 Fetal & maternal Monitor Service Manual Installation Figure 3-4 Securing Two Boards CAUTION Shut the display completely flat before mounting the monitor to the wall. Make sure the wall mounting board is firmly fixed to the wall. If there is any doubt, do not hang the monitor to this board.

  • Page 17: Connecting To Ac Power

    F9 Fetal & maternal Monitor Service Manual Installation Figure 3-5 The Monitor on a Trolley (Sketch Map) 3.5 Connecting to AC Power Apply the power cable provided with the monitor. Plug one end of the power cable to the power socket of the monitor.

  • Page 18: Chapter 4 Functional Checks

    F9 Fetal & maternal Monitor Service Manual Functional Checks Chapter 4 Functional Checks This section describes the procedure for a complete functional test to support recommended preventive-maintenance schedules. Functional checks do not require opening the device case. WARNING Only qualified service personnel should perform a full functional check procedure.

  • Page 19: Printing Check

    F9 Fetal & maternal Monitor Service Manual Functional Checks If you touch the center of a key but the monitor does not execute the right operation, calibrate the touch screen. Refer to section 5.5 Calibrating Touch Screen for details. If any operation failure is detected, refer to section 8.3 Touch Screen Failures for details.

  • Page 20: Chapter 5 System Configuration

    F9 Fetal & maternal Monitor Service Manual System Configuration Chapter 5 System Configuration The end users can not change the system configurations of the monitor. As a service engineer, you need to change these configurations for them after the monitor is installed and checked properly.

  • Page 21: Clearing Data

    F9 Fetal & maternal Monitor Service Manual System Configuration 5.4 Clearing Data The monitor saves the most recent 24-hour data in its long-term memory automatically. In order to delete this data, 1 Open the System Setup menu. 2 Select Clear Data.

  • Page 22: Changing The Device No

    F9 Fetal & maternal Monitor Service Manual System Configuration 5.7 Changing the Device No. This device No. determines the bedside monitor ID on the data receiving software, such as MFM-CNS central monitoring system of EDAN. 1 Open the System Setup menu.

  • Page 23: Configuring Wireless Network

    F9 Fetal & maternal Monitor Service Manual System Configuration MFM-CNS version is V3.7 or higher RS485 V1.3 F9 connects to Insight software via DB9 INSIGHT V1.2 interface. F9 connects to MFM-CNS or Insight ETHERNET MFM-CNS version is V3.4 or higher software via RJ45 interface.

  • Page 24: Configuring For Ethernet Connecting

    F9 Fetal & maternal Monitor Service Manual System Configuration 5.10 Configuring for Ethernet Connecting When connecting the monitor to a PC via Ethernet, you need to set the server IP and Ethernet port: 1 Open the System Setup menu. 2 Select Network Setup.

  • Page 25: Changing The Language

    F9 Fetal & maternal Monitor Service Manual System Configuration CAUTION To avoid inconsistency between FHR traces on the recorder paper and those on the screen, the paper style must comply with the style of the recorder paper being used. 5.13 Changing the Language The software supports several languages.

  • Page 26: Chapter 6 Maintenance

    F9 Fetal & maternal Monitor Service Manual Maintenance Chapter 6 Maintenance 6.1 Maintenance Inspections (1) Visual Inspection Prior to using the monitor 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 27: Maintenance Of The Transducers

    3) Remove dust on the paper sensing mechanism and paper sensor with a dry clean cloth. CAUTION Only use the recorder paper provided by EDAN, or it may damage the recorder. This kind of damage is not covered by warranty.

  • Page 28: Chapter 7 Principle Introduction

    For the fetal heart, the frequency offset of 1 MHz ultrasound source is about 60 ~ 400Hz (the standard adapted by EDAN). After being demodulating, amplified and filtered, the received ultrasound signals (the filter has a passband of 60 ~ 400Hz) are translated into fetal Doppler frequency offset signals.

  • Page 29: Decg Module Principle

    7.2 The System Principle Block Diagram F9 monitor consists of the main control board, fetal monitor (FM) module, DECG module, print board, power module, key board, LCD and corresponding interface boards. Here is the system principle block diagram:...

  • Page 30: Main Control Board

    Figure 7-2 The system principle block diagram 7.2.1 Main Control Board The main control board applied in F9 is the 2410 main control board. It fulfills the following function: key input control, LCD display, process print, audio alarm and led indicate light alarm, data memorize and recall, time and date management, communication with the internal modules, etc.

  • Page 31: Fetal Monitor Module

    F9 Fetal & maternal Monitor Service Manual Principle Introduction SDRAM: 64M byte EMS Memory Flash: program 8M bytes + data 64M bytes Serial Port Configure in 5 serial ports and 9 serial ports way Headphone Interface Loudspeaker output Touch Screen Interface 1 interface.

  • Page 32: Decg Module

    F9 Fetal & maternal Monitor Service Manual Principle Introduction Figure 7-3 Fetal monitor module circuit block diagram 7.2.3 DECG Module The DECG module fulfills the function of DECG detecting, TOCO and intrauterine pressure measuring, then send the results to the main control board through serial port.
  • Page 33 Principle Introduction Figure 7-4 Print controlling board principle block diagram The F9 recorder module includes: microprocessor MC9S12A64 circuit, power switch and control, communicate interface, motor control part, recorder paper detecting circuit, time control for printing power and heating, paper lacking temperature control and thermosensitive head protecting circuit.

  • Page 34: Power Module

    F9 Fetal & maternal Monitor Service Manual Principle Introduction (2) Interface connects to print head Pin No. Symbol VH_+24V VH_+24V VH_+24V THERMISTOR /STROBE_3 /STROBE_3 /STROBE_3 /STROBE_3 CLOCK /LATCH DATAIN (3) Interface connects to stepper motor (gear assembly) Pin No. Symbol...

  • Page 35: Key Board

    F9 Fetal & maternal Monitor Service Manual Principle Introduction F1 and F2 are two containers for fuses containing, the specification of the fuse is: 1.6A 250V. J1 is the equipotential grounding point that connects to the ground. J2 is a 3-pin socket for outer power input.

  • Page 36: Bottom Interfaces Board

    F9 Fetal & maternal Monitor Service Manual Principle Introduction 7.2.7 Bottom Interfaces Board F9 bottom interfaces board consists of connect CNS interconnection circuit, voltage switching circuit, built-in wireless module power circuit and interfaces. Interface definition (1) Interface connects to PS800B power module Pin No.
  • Page 37 F9 Fetal & maternal Monitor Service Manual Principle Introduction (5) Interface connects to main control board Pin No. Symbol Pin No. Symbol Pin No. Symbol ENERGY2 MB_RXD3 GND/BAT_V ENERGY1 MB_TXD3 MB_RXD0 MB_RXD7 MB_TXD0 MB_TXD7 +12V MB_RTS USB_DATA- USB_DATA+ SOFT_CLOSE BUSY...
  • Page 38 F9 Fetal & maternal Monitor Service Manual Principle Introduction (7) RJ45 Ethernet interface Pin No. Symbol Reserved Reserved Reserved Reserved (8) USB interface Pin No. Symbol USB_VCC USB_DATA- USB_DATA+ (9) 485 network interface Pin No. Symbol ISOVCC ISOCNS_RXD ISOCNS_TXD EXT_MODEL_EN (10) Interface connects to built-in wireless module Pin No.

  • Page 39: Lvds Lcd

    F9 Fetal & maternal Monitor Service Manual Principle Introduction 7.2.8 LVDS LCD LCD applies a 12.1” screen with LCDS interface from Taiwan AU Company. Its main technical specifications are as follows: Items Unit Specifications Screen Diagonal [mm] 310 (12.1”) Active Area [mm] 246.0(H) x 184.5(V)

  • Page 40: Interfaces

    (with a software such as Insight.), or to an obstetrical monitoring system such as MFM-CNS. 7.3.3 Antenna If the monitor has a wireless module built in it, an antenna will be configured. It is used to send signals of the F9 bedside monitor to the obstetrical monitoring system. - 34 -...

  • Page 41: Chapter 8 Troubleshooting

    It can also help you to have more exact descriptions of the fault symptoms when calling for service. EDAN supports replacement of PCBs and major subassemblies for this product. Verify the malfunction of the PCBAs / Modules prior to disassembling with the method described in chapter 9 Modules’...

  • Page 42: Display Failures

    F9 Fetal & maternal Monitor Service Manual Troubleshooting 8.2 Display Failures Phenomenon Possible Cause Solution The LCD related cable(s) is Check that the LCD related cables The LCD has no display. (are) disconnected. between the main control board, power inverter board and the LCD are well connected.

  • Page 43: Operation Failures

    F9 Fetal & maternal Monitor Service Manual Troubleshooting 8.4 Operation Failures Phenomenon Possible Cause Solution Bad key board connection. Check key board wire. Keys not functioning Key board is damaged. Replace the key board. When a key is pressed, no Loudspeaker or wire has a Replace the loudspeaker or the wire.

  • Page 44: Network Failures

    F9 Fetal & maternal Monitor Service Manual Troubleshooting 8.6 Network Failures Phenomenon Possible Cause Solution The RS232 or Ethernet socket Replace the RS232 or Ethernet defective. socket. The monitor can not connect to a network. connection between bottom interfaces board and main Check the connection.

  • Page 45: Fhr/Toco Monitoring Failures

    F9 Fetal & maternal Monitor Service Manual Troubleshooting Bad connection between DECG module, bottom interfaces board Check the connection. and main control board. DECG EQUIP MALF DECG board defective. Replace DECG board. Main control board defective. Replace main control board.

  • Page 46: Chapter 9 Modules' Malfunction Verification

    F9 Fetal & maternal Monitor Service Manual Modules’ Malfunction Verification Chapter 9 Modules’ Malfunction Verification When a module is suspected of malfunction, verify it using the method described in this chapter. NOTE: For all the interfaces, the first pin is the one with a square solder pad.
  • Page 47 F9 Fetal & maternal Monitor Service Manual Modules’ Malfunction Verification Rear of the Main control board ○ ○ 4) Compare the measurement results with the reference results in the list. If any one of the results exceeds the reference range, the main control board defection is confirmed.

  • Page 48: Verifying Malfunction Of The Fm Module

    F9 Fetal & maternal Monitor Service Manual Modules’ Malfunction Verification 9.2 Verifying Malfunction of the FM Module To verify the FM module, 1) Open the main unit using the procedures described in section 10.3. 2) Measure the voltage to earth of the pins listed below, using a multimeter:...
  • Page 49 F9 Fetal & maternal Monitor Service Manual Modules’ Malfunction Verification 3) Compare the measurement results with the reference results in the list. If all the results are in the allowance range. Switch on the monitor and measure the voltage to earth of the pins listed below.

  • Page 50: Verifying Malfunction Of The Decg Module

    F9 Fetal & maternal Monitor Service Manual Modules’ Malfunction Verification 9.3 Verifying Malfunction of the DECG Module To verify the DECG module, 1) Open the main unit using the procedures described in section 10.3. 2) Disconnect the DECG cable connector from the bottom interface board.

  • Page 51: Verifying Malfunction Of The Power Module

    F9 Fetal & maternal Monitor Service Manual Modules’ Malfunction Verification Item Reference result ○ (+3.3±5%) V ○ (+8±5%) V ○ (-8±5%) V ○ (+5±5%) V DECG Board ○ ○ ○ ○ 7) Compare the measurement results with the reference results in the list. If any one of the results exceeds the reference range, the DECG module defection is confirmed.

  • Page 52: Chapter 10 Disassembling The Monitor

    F9 Fetal & maternal Monitor Service Manual Disassembling the Monitor Chapter 10 Disassembling the Monitor WARNING Only qualified service personnel should open the monitor case. Switch off the monitor and remove the AC power cable before disassembling the monitor. After any repair of the monitor, perform safety tests before using the monitor again.

  • Page 53: Disassembling The Main Unit

    F9 Fetal & maternal Monitor Service Manual Disassembling the Monitor 5) Remove the old fuse. Take out a new fuse supplied by EDAN or of the same specification: Size: Ф5mm*20mm; Model: T1.6AL 250V. 6) Place the new fuse in the fuse socket. Press it in and screw it clockwise back in position.

  • Page 54: Disassembling The Lower Assembly

    F9 Fetal & maternal Monitor Service Manual Disassembling the Monitor lower assembly. 4) Hold both upper assembly and lower assembly together, place the monitor upright again. 5) Carefully lift up the upper assembly and place it upside down on the left side of the lower assembly.

  • Page 55: Replacing The Decg Module

    F9 Fetal & maternal Monitor Service Manual Disassembling the Monitor 3) Disconnect all the wires. 4) Remove the studs/screw securing the FM module. To replace the FM module, Replace the FM module in a reverse procedure. Refer to the following illustration when connecting wires.

  • Page 56: Replacing The Print Controlling Board

    F9 Fetal & maternal Monitor Service Manual Disassembling the Monitor To replace the DECG module, Replace the DECG module in a reverse procedure. Refer to the following illustration when connecting wires. Ensure they are all correctly connected. No. Connect to...

  • Page 57: Replacing The Printhead

    F9 Fetal & maternal Monitor Service Manual Disassembling the Monitor 10.4.4 Replacing the Printhead To remove the printhead, 1) Separate the upper assembly and the lower assembly. 2) Loosen the FM module by removing its fixing screws. 3) Remove the DECG module.
  • Page 58 F9 Fetal & maternal Monitor Service Manual Disassembling the Monitor Metal retainers ○ ○ ○ ○ ○ ○ Printhead connecting board 7) Take the printhead connecting board out from the monitor and then remove the four screws that fix the printhead.

  • Page 59: Replacing The Gear Assembly

    F9 Fetal & maternal Monitor Service Manual Disassembling the Monitor 10.4.5 Replacing the Gear Assembly To remove the gear assembly, 1) Separate the upper assembly and the lower assembly. 2) Disconnect the wires’ connector from the print controlling board. 3) Remove the three screws securing the gear assembly.

  • Page 60: Replacing The Power Module

    F9 Fetal & maternal Monitor Service Manual Disassembling the Monitor 10.4.7 Replacing the Power Module To remove the power module, 1) Separate the upper assembly and the lower assembly. 2) Disconnect all the wires on the module. 3) Remove the four screws securing the module.

  • Page 61: Replacing The Power Interface Board

    F9 Fetal & maternal Monitor Service Manual Disassembling the Monitor To replace the fan, Replace the fan in a reverse procedure. Ensure the wires’ connector is correctly connected to connector on the power cable bundle. 10.4.9 Replacing the Power Interface Board To remove the power interface board, 1) Separate the upper assembly and the lower assembly.

  • Page 62: Replacing The Bottom Interface Board

    F9 Fetal & maternal Monitor Service Manual Disassembling the Monitor 10.4.10 Replacing the Bottom Interface Board To remove the bottom interface board, 1) Separate the upper assembly and the lower assembly. 2) Disconnect all the wires on the board. 3) Remove the five screws securing the board.

  • Page 63: Replacing The Touch Screen Controlling Board

    F9 Fetal & maternal Monitor Service Manual Disassembling the Monitor To replace the main control board, Replace the main control board in a reverse procedure. Refer to the following illustration when connecting wires. Ensure they are all correctly connected. (vi)

  • Page 64: Replacing The Key Board

    F9 Fetal & maternal Monitor Service Manual Disassembling the Monitor 10.5.3 Replacing the Key Board To remove the key board, 1) Separate the upper assembly and the lower assembly. 2) Disconnect all the wires on the key board. 3) Remove the four screws securing the board.

  • Page 65: Replacing The Lcd

    F9 Fetal & maternal Monitor Service Manual Disassembling the Monitor 10.5.5 Replacing the LCD To remove the LCD, 1) Separate the upper assembly and the lower assembly. 2) Disconnect the five wires from the power inverter board, main control board and touch screen controlling board (shown with arrows).
  • Page 66 F9 Fetal & maternal Monitor Service Manual Disassembling the Monitor Display Assembly Stander 5) Remove seven screws on the back of display assembly and the two roll shaft covers. Roll Shaft Covers 6) Pull out the wires then open the display assembly with care.
  • Page 67 F9 Fetal & maternal Monitor Service Manual Disassembling the Monitor Touch screen signal cable No. Connect to Power inverter (left) Power inverter (right) Main control board (vi socket) Main control board (vii socket) Touch screen controller To replace the LCD, Replace the LCD in a reverse procedure.

  • Page 68: Chapter 11 Periodic Tests

    F9 Fetal & maternal Monitor Service Manual Periodic Tests Chapter 11 Periodic Tests 11.1 Safety Tests Safety tests should be performed by qualified personnel every 6 to 12 months, and each time after service. Use a standard safety tester to perform safety tests. The tester must comply with IEC/EN 60601-1 or the local standards and statutes.

  • Page 69: Toco Performance Test

    F9 Fetal & maternal Monitor Service Manual Periodic Tests 11.2.2 TOCO Performance Test This test checks the performance of TOCO measurement. Required Equipment: TOCO Test Kit, Weights 1) Connect the equipment and the monitor as shown: Weight F9 Monitor TOCO Test Kit TOCO Transducer 2) Switch on the monitor.

  • Page 70: Appendix 1 Renewal Parts

    F9 Fetal & maternal Monitor Service Manual Renewal Parts Appendix 1 Renewal Parts CAUTION Only connect the renewal parts supplied by EDAN to the monitor. Repair Part Part Number Speaker 11.14.038018 01.58.47177 01.16.52161 02.03.31022 Alarm Indicator Board PCBA 12.03.31002 Print Controlling Board 12.03.31020...

  • Page 71: Appendix 2 Connecting To Philips Ob Tracevue System

    Prior to connecting F9 to the OB TraceVue obstetrical documentation and surveillance system of Philips, make sure that 1) Net Version of F9 on the Network Setup interface has this option: PHILIPS . 2) The OB TraceVue system of Philips has a network interface (DB9 or RJ45) available.
  • Page 72 Port to RJ45 Cable #2 (M13R-036124). Otherwise use the cable #1 (MS1R-107702). Connection Put the convex plug of the Serial Port Cable into the DB9 interface of F9; put the concave plug of the Serial Port Cable into the free DB9 interface of the OB TraceVue system.
  • Page 73 Validation 1) Switch F9 to Demo mode. 2) Observe the surveillance window of the OB TraceVue system. If data from F9 is transferred to the system, the connection succeeds. Otherwise check the connection or try on another interface of the system.

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