EDAN F9 Express User manual

I
About this Manual
P/N: 01.54.107912-13
Release Date: Aug. 2010
© Copyright EDAN INSTRUMENTS, INC. 2009 - 2010. All rights reserved.
Statement
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.
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.
Materials protected by the copyright law, including but not limited to confidential information
such as technical information and patent information are contained in this manual, the user
shall not disclose such information to any irrelevant third party.
The user shall understand that nothing in this manual grants him, expressly or implicitly, any
right or license to use any of the intellectual properties of EDAN.
EDAN holds the rights to modify, update, and ultimately explain this manual.
Responsibility of the Manufacturer
EDAN only considers itself responsible for any effect on safety, reliability and performance
of the equipment if:
Assembly operations, extensions, re-adjustments, modifications or repairs are carried out by
persons authorized by EDAN, and
The electrical installation of the relevant room complies with national standards, and
The instrument is used in accordance with the instructions for use.
Upon request, EDAN may provide, with compensation, necessary circuit diagrams, and other
information to help qualified technician to maintain and repair some parts, which EDAN may
define as user serviceable.

II
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.
NOTE
A NOTE provides useful information regarding a function or a procedure.

III
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 ..................................................................................................... 8
3.4 Installing the Monitor.................................................................................................... 8
3.4.1 Installing the Monitor on a Flat Surface.............................................................. 8
3.4.2 Mounting the Monitor on a Wall......................................................................... 9
3.4.3 Installing the Monitor on a Roll Stand/Trolley ................................................. 10
3.5 Connecting to AC Power............................................................................................. 11
Chapter 4 Functional Checks................................................................................................12
4.1 Switching on Check .................................................................................................... 12
4.2 LCD Screen Check...................................................................................................... 12
4.3 Keys Check ................................................................................................................. 12
4.4 Touch Screen Check.................................................................................................... 12
4.5 Printing Check............................................................................................................. 13
4.6 Alarms Check.............................................................................................................. 13
Chapter 5 System Configuration..........................................................................................14
5.1 Opening System Setup Menu...................................................................................... 14
5.2 Entering Demo Mode .................................................................................................. 14
5.3 Reloading Default Settings.......................................................................................... 14
5.4 Clearing Data...............................................................................................................15
5.5 Checking Product Information .................................................................................... 15
5.6 Calibrating Touch Screen............................................................................................ 15
5.7 Changing the Device No. ............................................................................................ 16
5.8 Changing Net Version................................................................................................. 16
5.9 Configuring Wireless Network ................................................................................... 17
5.10 Configuring for Ethernet Connecting........................................................................ 18
5.11 Changing Trace Width .............................................................................................. 18
5.12 Changing Paper Style ................................................................................................ 18
5.13 Changing the Language............................................................................................. 19
5.14 Changing FHR Algorithm......................................................................................... 19
Chapter 6 Maintenance .........................................................................................................20

IV
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........................................ 22
7.1.3 Pressure Detecting Principle ............................................................................. 22
7.1.4 DECG Module Principle ................................................................................... 23
7.2 The System Principle Block Diagram......................................................................... 23
7.2.1 Main Control Board .......................................................................................... 24
7.2.2 Fetal Monitor Module ....................................................................................... 25
7.2.3 DECG Module................................................................................................... 26
7.2.4 Print Controlling Board..................................................................................... 26
7.2.5 Power Module ................................................................................................... 28
7.2.6 Key Board ......................................................................................................... 29
7.2.7 Bottom Interfaces Board ................................................................................... 30
7.2.8 LVDS LCD ....................................................................................................... 33
7.3 Interfaces ..................................................................................................................... 34
7.3.1 DB9 Interface .................................................................................................... 34
7.3.2 RJ45 Interface ................................................................................................... 34
7.3.3 Antenna ............................................................................................................. 34
Chapter 8 Troubleshooting ...................................................................................................35
8.1 Monitor Booting Failures............................................................................................ 35
8.2 Display Failures........................................................................................................... 36
8.3 Touch Screen Failures................................................................................................. 36
8.4 Operation Failures ....................................................................................................... 37
8.5 Recorder Failures ........................................................................................................ 37
8.6 Network Failures ......................................................................................................... 38
8.7 Alarms Failures ........................................................................................................... 38
8.8 Technique Alarms ....................................................................................................... 38
8.9 FHR/TOCO Monitoring Failures ................................................................................ 39
8.10 DECG/IUP Monitoring Failures ............................................................................... 39
Chapter 9 Modules’ Malfunction Verification....................................................................40
9.1 Verifying Malfunction of the Main Control Board..................................................... 40
9.2 Verifying Malfunction of the FM Module .................................................................. 42
9.3 Verifying Malfunction of the DECG Module ............................................................. 44
9.4 Verifying Malfunction of the Power Module.............................................................. 45
Chapter 10 Disassembling the Monitor................................................................................46

V
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 .................................................................................. 51
10.4.5 Replacing the Gear Assembly......................................................................... 52
10.4.6 Replacing the Speaker..................................................................................... 53
10.4.7 Replacing the Power Module .......................................................................... 54
10.4.8 Replacing the Fan............................................................................................ 54
10.4.9 Replacing the Power Interface Board.............................................................. 55
10.4.10 Replacing the Bottom Interface Board.......................................................... 56
10.5 Disassembling the Upper assembly........................................................................... 56
10.5.1 Replacing the Main control board................................................................... 56
10.5.2 Replacing the Touch Screen Controlling Board ............................................. 57
10.5.3 Replacing the Key Board ................................................................................ 58
10.5.4 Replacing the Power Inverter Board ............................................................... 58
10.5.5 Replacing the LCD.......................................................................................... 59
Chapter 11 Periodic Tests......................................................................................................62
11.1 Safety Tests ...............................................................................................................62
11.2 Performance Tests ..................................................................................................... 62
11.2.1 FHR Performance Test.................................................................................... 62
11.2.2 TOCO Performance Test................................................................................. 63
Appendix 1 Renewal Parts ....................................................................................................64
Appendix 2 Connecting to Philips OB TraceVue System...................................................65

F9 Fetal & maternal Monitor Service Manual Warranty and Service
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Chapter 1 Warranty and Service
Standard Service
EDAN provides a one-year-warranty for the warranted products (accessories are included). The
warranty period begins on the date the products are shipped to customers. If a customer promptly
notifies EDAN of customer’s warranty claim hereunder, EDAN will either repair, adjust or
replace (with new or exchange replacement parts) EDAN’s products. EDAN warrants that any
service it provides to customers will be performed by trained individuals in a workmanlike
manner.
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.
Unauthorized modification or misuse.
Damage caused by operating beyond the environmental specifications for the medical
product.
Change or remove original serial number label or Manufacturer symbol.
Improper use.
Service Procedure
(1) Fill in the Service Claim Form (SCF).
Fill in the SCF with detailed information including: Model Name, Serial Number (SN) and
Problem Phenomena.
EDAN should not have any obligation to take over the case without this information. The
form can be downloaded at: http://www.edan.com.cn or obtained from EDAN’s Service
Department.
(2) Send EDAN the SCF and Select a Solution.
Once the service department receives the fully filled SCF, EDAN’s engineer will offer a
solution in three working days. EDAN will follow out the case based on the two conditions
below:

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Within Warranty:
There are two options:
i) After receiving the Return Material Authorization (RMA) form from EDAN service
department, the customer sends EDAN the defective parts and informs about the shipment
tracking number. Then we will dispatch new part(s) to your confirmed address with
confirmed shipping invoice.
ii) The customer signs the Declaration Form and sends it back by email or fax. This form is
legally certificated to make sure the customer or end-user will return the defective parts to
EDAN on time. We will, at this option, dispatch the replacement one(s) with confirmed
shipping invoice.
NOTES:
1 Both Return Material Authorization Form and Declaration Form are offered by
EDAN service department once the SCF is confirmed by service engineer.
2 The customer is responsible for freight & insurance charges when the equipment
is shipped to EDAN for service, including custom charges. EDAN is responsible
for the freight, insurance & custom charges from EDAN to the customer.
Out of Warranty:
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.
NOTE: The customer is responsible for any freight & insurance charge for the
returned product.
(3) Obtain the RMA Form.
Before the shipment of the materials, the customer must obtain an RMA form from our
service department, in which the RMA number, description of returning parts and shipping
instructions are included. The RMA number should be indicated on the outside of the
shipping container.

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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.
(4) Send the Parts to EDAN.
Follow these recommended instructions:
Please disassemble the parts with anti-static facility, do not touch the parts with naked hand.
Please pack the parts safely before return.
Please put the RMA number on the parcel.
Please describe the returned parts as ‘sample of *****’ and put the total value on the invoice,
and note on the invoice as ‘sample, no commercial value’.
Please confirm the invoice with EDAN before shipment.
Please send back the parts after EDAN’s confirmation.
Contact Information
If you have any question about maintenance, technical specifications or malfunctions of devices,
do not hesitate to contact us.
EDAN Instruments, Inc.
TEL: [phone]
FAX: [phone]
E-mail: [email protected]

F9 Fetal & maternal Monitor Service Manual Overview
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Chapter 2 Overview
NOTE:
This service manual is written to cover the maximum configuration. Therefore, your
model may not have some of the parameters / modules described, depending on what
you have ordered.
2.1 Introduction
This service manual is a reference for periodic preventive maintenance and corrective service
procedures for the F9 fetal & maternal monitor.
It provides troubleshooting information, assembly procedures, instructions for functional testing
and performance verification. It is intended for use only by technically qualified service
personnel.
WARNING
When performing a service procedure, follow the instructions exactly as presented in this
manual. 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.
The protective categories against electric shock of the patient connections are:
1) Ultrasound (FHR1, FHR2) 2) External TOCO
3) Remote Event Marker (FM) 4) Fetal Stimulator (FS)
This symbol indicates that the electric shock defending grade of this instrument is Type B.
1) IUP 2) NIBP 3) SpO2
This symbol indicates that the electric shock defending grade of this instrument is Type BF.

F9 Fetal & maternal Monitor Service Manual Overview
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1) DECG 2) ECG 3) TEMP
This symbol indicates that the electric shock defending grade of this instrument is Type CF.
The monitor described in this user manual is not protected against:
The effects of defibrillator shocks
The effects of defibrillator discharge
The effects of high frequency currents
The interference of electrosurgery equipment
2.3 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
1 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.
2 The service personnel should be familiar with the operation of this monitor. Refer to
F9 Fetal & maternal Monitor User Manual for details.
3 Perform periodic safety testing to insure proper patient safety. This should include
leakage current measurement and insulation testing. The recommended testing
interval is once per year.
4 Disconnect the power cord before changing fuses. Replace them with the fuses of
the same specifications.
5 SHOCK HAZARD - Do not attempt to connect or disconnect a power cord with wet
hands. Make sure that your hands are clean and dry before touching a power cord.
6 SHOCK HAZARD - Do not remove the top panel cover during operation or while
power is connected. Only authorized service personnel could remove the unit cover.

F9 Fetal & maternal Monitor Service Manual Overview
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WARNING
7 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. Everybody who connects additional equipment to the signal input
connector or signal output connector configures a medical system, and is therefore
responsible that the system complies with the requirements of the valid version of
the system standard IEC/EN 60601-1-1. If in doubt, consult our technical service
department or your local distributor.
8 Do not unplug the battery in the course monitoring.
9 Do not connect battery directly to an electric outlet or cigarette lighter charger.
10 Do not solder the leading wire and the battery terminal directly.
CAUTION
1 Refer servicing to qualified personnel.
2 The device is designed for continuous operation and is “ordinary” (i.e. not drip or
splash-proof).
3 Do not operate the unit if it is damp or wet because of condensation or spills. Avoid
using the equipment immediately after moving it from a cold environment to a warm,
humid location
4 While the battery is charged, used or stored, keep it away from objects or materials
with static electric charges.

F9 Fetal & maternal Monitor Service Manual Installation
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Chapter 3 Installation
WARNING
Only qualified service engineers should install this equipment.
3.1 Environment Requirements
Working Environment
Temperature: +5 ºC ~ +40 ºC ( +41ºF ~ +104ºF)
Relative Humidity: 25% ~ 80% (non-condensing)
Atmospheric Pressure: 860hPa ~ 1060hPa
Classification
Anti-electric Shock Type: Class I equipment with internal power supply
Anti-electric Shock Degree: Type B applied parts
Main Unit: Not-protected
Degree of Protection against
Harmful Ingress of Water: Transducer: IPX8
Degree of Safety in Presence of
Flammable Gases:
Equipment not suitable for use in presence of
flammable gases
Disinfection/Sterilizing Method: Refer to User Manual for details
EMC: Group I Class A
If the monitor is installed in a cabinet, allow at least 2 inches (5 cm) clearance around
the monitor for proper air circulation; allow adequate accessibility for servicing, and
adequate room for visualization and operation.
Ensure the monitor is not subjected to any source of strong electromagnetic interference,
such as CT, radio transmitters, mobile phones base stations, etc.
Do not install the monitor in a flammable atmosphere where concentrations of
flammable anesthetics or other materials may occur.
Keep the environment clean. Avoid vibration. Keep it far from corrosive medicine, dust
area, high-temperature and humid environment.

F9 Fetal & maternal Monitor Service Manual Installation
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3.2 Electrical Requirements
Operating Voltage:
Operating Frequency:
Input Power:
100V-240V ~
50Hz/60Hz
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. If the outlet has only two slots, make sure that it is replaced with a
three-slot grounded outlet before attempting to operate the monitor.
Do not touch signal input or output connector and the patient simultaneously.
Equipment and devices that connect to the monitor should form an equipotential body to
ensure effective grounding.
Do not switch on the monitor until all cables have been properly connected and verified.
3.4 Installing the Monitor
3.4.1 Installing the Monitor on a Flat Surface.
Place the monitor on a flat surface. Make sure the surface does not vibrate, and is free of
corrosive medicine and dust.
Figure 3-1 The monitor on a flat surface

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3.4.2 Mounting the Monitor on a Wall
To mount the monitor on a wall,
1Order a wall mounting board (MS1R-107983) and a connecting board (MS1R-107984)
from the manufacturer.
2Turn the monitor over and fix the connecting board to the bottom panel using two pan
head screws.
Figure 3-2 Fixing Connecting Board
Figure 3-3 Fixing Wall Mounting Board
3Fix the wall mounting board to the wall with six self-tapping screws.
4Lift the monitor with the bottom panel facing the wall. Let the four posts on the board
stretch into wall-mounting holes and then release your hands from the monitor slowly.
5Secure the connecting board to the wall mounting board with a pan head screw.
WALL

F9 Fetal & maternal Monitor Service Manual Installation
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Figure 3-4 Securing Two Boards
CAUTION
1 Shut the display completely flat before mounting the monitor to the wall.
2 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.
3 Make sure the monitor is safely hung on the posts of the board before releasing your
hands from the monitor.
3.4.3 Installing the Monitor on a Roll Stand/Trolley
An Assembling Instruction will be delivered with the roll stand/trolley. Refer to that instruction
for details of installing the monitor on a roll stand/trolley.

F9 Fetal & maternal Monitor Service Manual Installation
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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. Connect the other end to a grounded 3-slot power output special for
hospital usage.

F9 Fetal & maternal Monitor Service Manual Functional Checks
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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.
Whenever the monitor is serviced or problems are suspected, the manufacturer recommends a full
functional check procedure.
4.1 Switching on Check
Press the POWER switch on right panel to switch on the monitor.
Check if the power indicator lights up; if a start-up tone is heard. if the screen lights up in a few
seconds.
If any failure is detected, refer to section 8.1 Monitor Booting Failures for details.
4.2 LCD Screen Check
Observe if some characters are missing, or there are bright spots and dark shadows on the LCD
screen. Observe if the waveforms, fonts and symbols displayed on the LCD screen are normal.
If any failure is detected, refer to section 8.1 Monitor Booting Failures for details.
4.3 Keys Check
Press the keys on the front panel to check if they work properly. When pressing a key, a normal
key tone should be heard, unless its related function is disabled.
If any failure is detected, refer to section 8.2 Display Failures for details.
4.4 Touch Screen Check
When the monitor is configured with touch screen, touch any available keys on the screen to
check if it is working properly.

F9 Fetal & maternal Monitor Service Manual Functional Checks
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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.
4.5 Printing Check
Press the PRINT key to start printing. Check if the recorder starts printing.
Enable the Print Self-Test function in the recorder’s configuration. Restart the monitor and verify
if the recorder prints a baseline.
Enter DEMO mode and print some traces and check if all the traces are clear on the paper.
If any failure is detected, refer to section 8.5 Recorder Failures for details.
NOTE:
Please make sure the paper loading and setting are correct before the printing starts.
4.6 Alarms Check
Stimulate a signal that is higher than the upper limit or lower than the lower limit to activate a
physical alarm. Disconnect one of the plugs to of the monitor to activate a technical alarm. Check
if the audible alarms and visible alarms are working properly.
If any failure is detected, refer to section 8.7 Alarm Failures for defective details.

F9 Fetal & maternal Monitor Service Manual System Configuration
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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.
NOTE:
Restart the monitor after changing the settings.
5.1 Opening System Setup Menu
The system configurations of the monitor are to be changed in the system setup menu. To open
this menu,
1 Select the setup key on the main interface.
2 Select System.
3 Input the password 9999 on the soft keyboard.
4 Select Ok on the soft keyboard.
5.2 Entering Demo Mode
The monitor works in real-time monitoring mode when monitoring a patient. If you want to show
the traces and parameters for a demonstration, you need to enter the Demo mode.
1 Open the System Setup menu.
2 Select Demo.
3 Select OK.
5.3 Reloading Default Settings
The default settings are predefined in the factory. Users can change the monitor setup, but this
default configuration stays the same. To reload this default,
1 Open the System Setup menu.
2 Select Default.
3 Select OK.