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Statement
Edan Instruments, Inc. (hereinafter called EDAN) makes no warranty of any kind with regard
to this material, including, but not limited to the implied warranties of merchantability and
fitness for a particular purpose. EDAN assumes no responsibility for any error that may
appear in this document, or for incidental or consequential damage in connection with the
furnishing, performance or use of this material.
All information contained in this publication is believed to be correct. EDAN shall not be
liable for errors contained herein nor for incidental or consequential damages in connection
with the furnishing, performance, or use of this material. This publication may refer to
information and protected by copyrights or patents and does not convey any license under the
patent rights of this company, nor the rights of others. This company does not assume any
liability arising out of any infringements of patents or other rights of third parties.
Product Information
Product Name: Fetal & maternal Monitor
The electrical installation of the relevant room complies with national standards, and
I
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.
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.
Revision History
II
Table of Contents
Chapter 1 Warranty and Service............................................................................................ 1
Chapter 2 Overview ................................................................................................................. 4
2.1 Introduction ................................................................................................................... 4
2.1 General Information ...................................................................................................... 4
2.2 Safety Precautions ......................................................................................................... 5
2.3 Definitions and Symbols ............................................................................................... 6
Chapter 3 Installation .............................................................................................................. 9
3.1 Environment Requirements........................................................................................... 9
3.2 Electrical Requirements ................................................................................................ 9
3.3 Safety Requirements ..................................................................................................... 9
3.4 Installing the Monitor.................................................................................................. 10
3.5 Connecting to AC Power............................................................................................. 11
Chapter 4 Function 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 To Enter System Setup Menu...................................................................................... 14
5.2 To Enter Demo Mode.................................................................................................. 14
5.3 To Clear Data .............................................................................................................. 14
5.4 To Calibrate Touch Screen.......................................................................................... 14
5.5 To Reload Factory Default.......................................................................................... 15
5.6 To Change the Language............................................................................................. 15
5.7 To Change Paper Style................................................................................................ 15
5.8 To Change Paper Vendor ............................................................................................ 16
5.9 To Change the Device No. .......................................................................................... 16
5.11 To Change Net Version............................................................................................. 17
5.12 To Configure for Wireless Network.......................................................................... 17
5.13 To Configure for Ethernet Connecting...................................................................... 18
5.14 To Enable/Disable Touch Screen.............................................................................. 18
Chapter 6 Maintenance ......................................................................................................... 19
6.1 Maintenance Inspection............................................................................................... 19
6.2 Maintenance of the Monitor........................................................................................ 19
6.3 Maintenance of the Transducers ................................................................................. 20
6.4 Maintenance of the Recorder ...................................................................................... 20
Chapter 7 Principle Introduction ......................................................................................... 21
7.1 Modules Principle ....................................................................................................... 21
7.1.1 Ultrasound Doppler ........................................................................................... 21
7.1.2 Fetal movement Doppler Signal Detecting Principle........................................ 21
7.1.3 Pressure Detecting Principle ............................................................................. 21
7.1.4 DECG Module Principle ................................................................................... 22
7.1.5 MECG Principle................................................................................................ 22
III
7.1.6 NIBP Principle .................................................................................................. 25
7.1.7 SpO2 Principle ................................................................................................... 27
7.1.8 TEMP principle ................................................................................................. 28
7.2 The System Principle Block Diagram......................................................................... 28
7.2.1 Main Control Board .......................................................................................... 29
7.2.2 Fetal Monitor Module ....................................................................................... 30
7.2.3 DECG Module................................................................................................... 31
7.2.4 ECG (E3) Module ............................................................................................. 32
7.2.5 NIBP (V6) Module............................................................................................ 33
7.2.5 SpO2 (A6) Module ............................................................................................ 33
7.2.6 Print Controlling Board..................................................................................... 34
7.2.7 Power Module ................................................................................................... 35
7.2.8 Key Board ......................................................................................................... 36
7.2.9 Bottom Interfaces Board ................................................................................... 37
7.2.10 LVDS LCD ..................................................................................................... 40
7.3 Interfaces ..................................................................................................................... 41
7.3.1 DB9 Interface .................................................................................................... 41
7.3.2 RJ45 Interface ................................................................................................... 42
7.3.3 Antenna ............................................................................................................. 42
Chapter 8 Troubleshooting ................................................................................................... 43
8.1 Monitor Booting Failures ............................................................................................ 43
8.2 Display Failures........................................................................................................... 44
8.3 Touch Screen Failures................................................................................................. 44
8.4 Operation Failures ....................................................................................................... 45
8.5 Recorder Failures ........................................................................................................ 45
8.6 Network Failures ......................................................................................................... 46
8.7 Alarms Failures ........................................................................................................... 46
8.8 Technique Alarms ....................................................................................................... 46
8.9 FHR/TOCO Monitoring Failures ................................................................................ 47
8.10 DECG/IUP Monitoring Failures ............................................................................... 48
8.11 ECG Monitoring Failures.......................................................................................... 48
8.12 SpO2 Monitoring Failures ......................................................................................... 48
8.13 NIBP Monitoring Failures......................................................................................... 49
8.14 TEMP Monitoring Failures ....................................................................................... 49
Chapter 9 Modules’ Malfunction Verification .................................................................... 50
9.1 To Verify Malfunction of the Main Control Board..................................................... 50
9.2 To Verify Malfunction of the FM Module.................................................................. 52
9.3 To Verify Malfunction of the DECG Module............................................................. 54
9.4 To Verify Malfunction of the NIBP Module .............................................................. 55
9.5 To Verify Malfunction of the SpO2 Module .............................................................. 57
9.6 To Verify Malfunction of the ECG Module................................................................ 58
9.7 To Verify Malfunction of the Power Module ............................................................. 59
Chapter 10 Disassembling the Monitor................................................................................ 60
10.1 Tools Required .......................................................................................................... 60
10.2 To Replace Fuses ...................................................................................................... 60
10.3 To Disassemble the Main Unit.................................................................................. 61
10.4 To Disassemble the Lower assembly ........................................................................ 62
10.4.1 To Replace the FM Module ............................................................................ 62
10.4.2 To Replace the DECG Module ....................................................................... 63
IV
10.4.3 To Replace the Print Controlling Board.......................................................... 64
10.4.4 To Replace the Gear Assembly....................................................................... 65
10.4.5 To Replace the Speaker................................................................................... 65
10.4.6 To Replace the Power Module ........................................................................ 66
10.4.7 To Replace the Fan.......................................................................................... 66
10.4.8 To Replace the Power Interface Board ........................................................... 67
10.4.9 To Replace the NIBP Module ......................................................................... 68
10.4.10 To Replace the SpO2 Module........................................................................ 69
10.4.11 To Replace the ECG Module ........................................................................ 70
10.4.12 To Replace the Bottom Interface Board........................................................ 71
10.5 To Disassemble the Upper assembly ........................................................................ 72
10.5.1 To Replace the Main control board................................................................. 72
10.5.2 To Replace the Touch Screen Controlling Board ........................................... 72
10.5.3 To Replace the Key Board .............................................................................. 73
10.5.4 To Replace the Power Inverter Board ............................................................. 73
10.5.5 To Replace the LCD........................................................................................ 74
Chapter 11 Periodic Tests...................................................................................................... 77
11.1 Safety Tests ............................................................................................................... 77
11.2 Performance Tests ..................................................................................................... 77
11.2.1 FHR Performance Test.................................................................................... 77
11.2.2 TOCO Performance Test................................................................................. 78
11.2.3 ECG Performance Test.................................................................................... 78
11.2.4 SpO2 Performance Test .................................................................................. 79
11.2.5 NIBP Performance Test .................................................................................. 80
11.2.6 TEMP Performance Test................................................................................. 80
Appendix 1 Signal Input/Output Connector ....................................................................... 81
Appendix 2 Renewal Parts .................................................................................................... 82
V
F9 Series Fetal & maternal Monitor Service Manual
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 customer promptly
notifies EDAN of customer’s warranty claim hereunder, EDAN will either repair, adjust or
replace (with new or exchange replacement parts) the EDAN’s product. 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 are
not responsible may void the warranty:
Service Procedure
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.
Once 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 below two conditions:
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F9 Series Fetal & maternal Monitor Service Manual
Within Warranty:
i) After receiving the Return Material Authorization (RMA) form from EDAN service
department, customer sends EDAN the defective parts and informs the shipment tracking
number. Then we will dispatch new part(s) to your confirmed address with confirmed
shipping invoice.
ii) 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 replace one(s) with confirmed shipping
invoice.
NOTE:
(1) Both Return Material Authorization Form and Declaration Form are offered
by EDAN service department once the SCF is confirmed by service
engineer.
(2) 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
customer.
Out of Warranty:
After receiving the RMA from service department, customer sends defective parts to EDAN
in advance. We will analyze the problems and discuss with 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 confirmed address.
NOTE: Customer is responsible for any freight & insurance charge for the
returned product.
Before the shipment of the materials, customer must obtain a RMA form from our service
department, in which the RMA number, description of returning parts and shipping
instruction are included. The RMA number should be indicated on the outside of the shipping
container.
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F9 Series Fetal & maternal Monitor Service Manual
NOTE: EDAN should not have any obligation to end-user or customer who returns
the goods without the notification by EDAN’s service department. The
sender takes the whole responsibility of accounted fee.
² Disassemble the parts with anti-static facility. Do not touch the parts with naked hand.
² Pack the parts safely before returning.
² Put the RMA number on the parcel.
² Describe the returned parts. The total value on the invoice should be less than USD100, and
note on the invoice as “sample, no commercial value”.
² Confirm the invoice with EDAN before shipment.
² 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.
E-mail: support@edan.com.cn
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F9 Series Fetal & maternal Monitor Service Manual
Chapter 2 Overview
NOTE: This service manual is written to cover the biggest 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 series (F9, F9 Express) fetal & maternal monitor.
Z The F9 Series Fetal & maternal Monitor (hereinafter called F9 Series) is designed to comply
with the international safety requirements IEC/EN 60601-1 for medical electrical equipment.
It is class I equipment.
Z The protective categories against electric shock of the patient connections are:
This symbol indicates that the electric shock defend grade of this instrument is Type B.
This symbol indicates that the electric shock defend grade of this instrument is Type BF.
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F9 Series Fetal & maternal Monitor Service Manual
This symbol indicates that the electric shock defend grade of this instruments is Type CF.
WARNING and CAUTION messages must be observed. To avoid the possibility of injury,
observe the following precautions during the operation of the instrument.
WARNING :
Z The service personnel should be familiar with the operation of this monitor. Refer to
F9 Series Fetal & maternal Monitor User Manual for details.
Z 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.
Z Disconnect power cord before changing fuse. Replace with the same rating and
type only.
Z SHOCK HAZARD - Do not attempt to connect or disconnect a power cord with wet
hands. Make certain that your hands are clean and dry before touching a power
cord.
Z SHOCK HAZARD - Do not remove the top panel covers during operation or while
power is connected. Only authorized service personnel could remove the unit
cover.
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F9 Series Fetal & maternal Monitor Service Manual
Z Don’t solder the leading wire and the battery terminal directly.
CAUTION :
Z The device is designed for continuous and is “ordinary” (i.e. not drip or
splash-proof).
Z 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
Z While the battery is charged, used and stored, keep it away from objects or
materials with static electric charges.
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F9 Series Fetal & maternal Monitor Service Manual
Socket for Remote Event Marker (for connection with the marker,
Protection Category B)
DB9 Interface
RJ45 Interface
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F9 Series Fetal & maternal Monitor Service Manual
Part Number
Serial Number
Date Of Manufacture
Manufacturer
Recycle
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F9 Series Fetal & maternal Monitor Service Manual
Chapter 3 Installation
Working
Temperature: 5 ºC ~ 40 ºC ( 41ºF ~ 104ºF)
Relative Humidity: 25% ~ 80% (non-condensing)
Atmospheric Pressure: 860hPa ~ 1060hPa
Z 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.
Z Ensure the monitor is not subjected to any source of strong electromagnetic interference,
such as CT, radio transmitters, mobile phones base stations, etc.
Z Keep the environment clean. Avoid vibration. Keep it far from corrosive medicine, dust area,
high-temperature and humid environment.
Z 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
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F9 Series Fetal & maternal Monitor Service Manual
Z Do not touch signal input or output connector and the patient simultaneously.
Z Equipment and devices that connect to the monitor should form an equipotential body to
ensure effective grounding.
Z Do not switch on the monitor until all cables have been properly connected and verified.
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F9 Series Fetal & maternal Monitor Service Manual
² Fix the wall mounting board to the wall with six screws.
² Lift the monitor with the bottom panel facing the wall.
² Let the four posts on the board stretch into wall-mounting holes.
CAUTION :
Z Shut the display completely flat before mounting the monitor to the wall.
Z 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.
Z Make sure the monitor is safely hung on the posts of the board before
releasing your hands from the monitor.
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F9 Series Fetal & maternal Monitor Service Manual
WARNING : Only qualified service personnel should perform a full function check
procedure.
Whenever the monitor is serviced or problems are suspected, the manufacturer recommends a full
function check procedure.
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.
If any failure is detected, refer to section 8.1 Monitor Booting Failures for details.
If any failure is detected, refer to section 8.2 Display Failures for details.
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F9 Series Fetal & maternal Monitor Service Manual
If you touch the center of a key but the monitor does not execute the right operation, calibrate the
touch screen. Refer to section 5.4 To Calibrate Touch Screen for details.
If any operation failure is detected, refer to section 8.3 Touch Screen Failures for details.
Switch on 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 start printing.
If any failure is detected, refer to section 8.7 Alarm Failures for defective details.
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F9 Series Fetal & maternal Monitor Service Manual
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.
2 Select System.
3 Select Password then input the password 9999.
4 Select ok on the soft keyboard.
In the system setup menu, you can find change the network configuration, hardware
configuration, service and other items. Also, the software information is shown in the bottom left
corner.
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F9 Series Fetal & maternal Monitor Service Manual
NOTE: Make sure the touch screen is enabled before trying to enter touch screen
calibration menu.
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F9 Series Fetal & maternal Monitor Service Manual
CAUTION : To avoid inconsistency between FHR traces on the recorder paper and
the screen, the paper style must comply with the style of the recorder
paper being used.
CAUTION : To avoid inconsistency between FHR traces on the recorder paper and
the screen, the paper vendor must comply with the vendor of the
recorder paper being used.
CAUTION : Make sure the device numbers of the monitors in the same system do
not overlap.
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F9 Series Fetal & maternal Monitor Service Manual
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F9 Series Fetal & maternal Monitor Service Manual
NOTE: Refer to MFM-CNS Wireless Network Installation Guide for details of setting
wireless network.
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F9 Series Fetal & maternal Monitor Service Manual
Chapter 6 Maintenance
Z Check the monitor and accessories to see if there is any visible damage that may affect
patient’s safety.
Z Check all the outer cables, power socket and power cables.
If any damage is detected, replace the damage part(s) or contact EDAN immediately.
The overall check of the monitor, including the safety check and functions check, should be
performed by qualified personnel once every 6 to 12 months, and each time after service.
The equipment should undergo periodic safety test to insure proper patient isolation from leakage
currents. This should include leakage current measurement and insulation testing. The
recommended testing interval is once a year or as specified in the institution’s test and inspection
protocol.
Pay particular attention to the supply socket. Replace any cable that shows serious damage.
The gathering of dew in the screen may occur with abrupt temperature or humidity changes. A
table environment is recommended.
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F9 Series Fetal & maternal Monitor Service Manual
Keep the transducers in a dry environment with the temperature lower than 45°C (113°F).
Wipe off coupling gel from the ultrasound transducer after us to prolong the life of the transducer.
Handle the transducers with care. Rough handling could damage the cover, piezoelectric crystals
and mechanical movement. Contacting the transducers with hard or sharp objects should be
avoided.
1) Clean the recorder platen with a lint-free cloth and soap/ water solution.
2) Wipe the thermal array using a cotton swab moistened with 70% Isopropyl alcohol-based
solution.
3) Remove dust on the paper sensing mechanism and paper sensor with a dry clean cloth.
WARNING :
Only use the recorder paper provided by EDAN, or it may damage the recorder. This
kind of damage is not covered by warranty.
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F9 Series Fetal & maternal Monitor Service Manual
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. For the convenience of calculating, we envelope these signals after that.
Then DSP does autocorrelation calculation to the A/D sampled results and figure out the fetal
heart rate.
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F9 Series Fetal & maternal Monitor Service Manual
R8 are installed on both sides of the spring, the spring’s being forced causes the resistance of R1
and R8 to change, one increases the other decreases, and the increment equals to the decrement.
Apply voltage at E1 and E4, change of resistance becomes change of voltage. The formula is:
∆R ∆R
E2 = ( E1 − E 4) = ( E1 − E 4)
R1 + ∆R + R8 − ∆R 2R
In the formula, R denotes the resistance of R1 and R8 when there is no distortion (R1=R8).
Amplify the difference between E2 and E3 with an apparatus amplifier, now the change of
pressure has become change of voltage, which is simple for the system to measure.
Figure 7-1 Internal circuit in TOCO transducer
IUP measuring principle: sense the pressure of inner uterine with the IUP transducer; transform
the pressure signals into electricity signals; amplify and filter them with Front-End circuit; the
microprocessor calculates the pressure; transfer the result to the main control board through serial
port.
The electrochemistry activity of “excitable cells” in cardiac muscle makes the muscle excite and
the heart contract mechanically. The activation of the heart generates close action current that
flows in human body to every part, which causes potential difference on the surface of every part.
The electrocardiogram records the real time potential difference changes on the body surface.
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F9 Series Fetal & maternal Monitor Service Manual
ECG Lead
This electric activity of heart is first discovered and recorded by WALLER in 1889. In 1903, a
German EINTHOVEN improved the recording equipment and brought in some concepts, which
are still widely in use today, including marking the ECG wave with letters PQRSTU and the
concept of leads.
Lead means the waveform of potential difference between two or more than two parts of the body
surface changing with heart beat circle. The earliest I, II, III lead defined by EINTHOVEN is
called Bipolar Limb Lead; later GOLDBURGER defined Augmented Unipolar Limb Lead aVH,
aVL and aVF, WILSON defined Nonpolar Precordial Lead V1, V2, V3, V4, V5 and V6. They are
standard ECG leads in clinic at the present time.
The heart is solid, a lead waveform indicates the electric activity of heart on a projection surface;
the 12 leads indicate the heart electric activity on 12 different projection surfaces. Consequently
the physicians can diagnose the pathological changes on different parts of the heart.
For the moment, the standard electrocardiograph in clinic places the limb electrodes on wrists and
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F9 Series Fetal & maternal Monitor Service Manual
ankles. But for the monitor, the electrodes are placed on the patient’s chest and abdomen. In spite
of the different positions, they are equivalent and have same definition. Therefore, the monitoring
leads correspond to electrocardiograph leads; they have same polarity and waveform.
The monitor monitors 3 or 6 leads, simultaneously displays the waveform of one or two leads,
and picks up parameters through waveform analyzing. Powerful monitors can monitor 12 leads
and analyze the waveform, then picks up ST band and arrhythmia events.
But ECG monitoring can not completely take the place of standard electrocardiograph. For the
monitored ECG waveform at present can not provide its slighter structure. This is mainly because
of their different purpose, the monitor observes the patient’s real time heart rhythm for a long
period; the electrocardiograph gets the result of certain condition in a short time. As a result, these
two types of equipment have different amplifier pass band width in measuring circuit; the
electrocardiograph’s band is 0.05-80Hz; that of the monitor is 1-25Hz.
The ECG signal is a faint electrical signal and interfered easily by outside environment. Even the
manufacturers have taken consider of this and taken some measures to enhance the machines’
anti-jamming ability, some of the interference are still unconquerable.
Power-line interference comes from the alternating current (50Hz-60Hz) that inputs to the
monitor. This is a common interference. Because of its constant frequency it is easy for the
equipment to avoid it with a band-pass filter.
The contraction of the muscles under the electrodes generates muscle electricity, which will
interfere with ECG signals. Its same spectrum and bandwidth as ECG signal makes it impossible
to be avoided with filter.
The patient’s breathing causes low frequency excursion of ECG signal. But they are lower than
the low frequency extreme of the amplifier; the monitor can handle this interference.
The patient’s movement causes the change of ECG signals. The degree of influence depends on
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F9 Series Fetal & maternal Monitor Service Manual
the movement’s amplitude and frequency. If it’s within the ECG amplifying bandwidth, it will be
hard for the monitor to conquer.
Any interference on the path of the body to ECG amplifier will cause strong noise, which will
make the ECG waveform indistinct. The noise might be caused by the bad connection between
electrodes and skin, cable disconnection or bad grounding of the equipment, for example, the
electrodes are not attached to the skin firmly, electric paste of electrodes is dry, the skin is not
well prepared, the cable is not well connected or broken. To avoid these, the user has to be very
careful when checking and using the equipment. Besides, the equipment has to be grounded
reliably, which is not only good for anti-inference, but also for the safety of both the patient and
the operator.
If a high frequency electric knife is used during an operation, the ECG waveform will be badly
influenced. As the electrical energy on the body is much stronger than the ECG signals in
amplitude; its rich frequency composition makes the ECG amplifier reach saturated condition and
not be able to monitor the normal ECG waveform. For the time being no monitor can avoid this
type of interference. As a result, the anti-interference requirement for electric knife of the monitor
is: the monitor resumes order after the high frequency electric knife is removed for 5 seconds.
Blood pressure is the force of blood pushing against the walls of the vases; this force change
along with every systole and diastole. And the pressure to the arteries and veins are different, so
is the pressure of different parts of the body. Normally we concern the systolic pressure and
diastolic pressure of the artery in the upper arm at the height of the heart as the blood pressure,
they are called systolic pressure and diastolic pressure.
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F9 Series Fetal & maternal Monitor Service Manual
The precondition of oscillometric method is to find out regular arterial pressure pulsation. Or it
might result in unreliablility of the measured result, increasing of measuring time or even
measuring failure. For example, if the patient’s movement or outer distraction interferes with the
pressure change of air in the cuff during measurement, the monitor will not be able to detect the
regular arterial wave, which might cause measuring failure. This the same thing as that happens
in measuring blood pressure with Korotkoff Sound Method, if the patient’s arm moves, the doctor
can not hear pulse sound clear or distinguish blood pressure.
Although oscillometric method is an objective and effective method of measuring NIBP, it has its
weakness and limitation in clinical use.
2. Serve arrhythmia. The result might be interfered if the patient’s heart beat is irregular because
of serve arrhythmia.
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F9 Series Fetal & maternal Monitor Service Manual
3. Serve shock. Because of the shock patient’s reduced blood flowing to the periphery, the
arterial pulse reduces or vanishes. The measuring result is even more unreliable.
4. Too low or too high blood pressure or heart rate. They will cause the inaccurateness of the
measuring result.
As a result, the oscillometric method is not omnipotent. In order to assure the measuring result’s
validity, user should estimate it according to the real condition.
Besides, make sure to have an ideal condition when measuring NIBP with oscillometric method;
mind the cuff’s size, position and degree of tightness.
Noninvasive arterial pulse oxygen saturation (SpO2) measuring is a technique developed in early
1980s. It bases on the different absorption character of haemoglobin (Hb) and oxyhemoglobin
(HbO2) to light, applying red glow (660nm) and infrared ray (940nm) to penetrate the tissue
respectively, then be received by photosensor and transferred into electric signals. Meanwhile, the
absorption character of other elements in the tissue, such as skin, skeleton, muscle and vein blood
is constant, only the absorption character of Hb and HbO2 in arteries changes periodically with
pulse. This feature also makes it possible to acquire the SpO2 via processing the received signals.
This method only measures the SpO2 in arterial blood, and the necessary condition is there is
pulsed arterial blood flow. As a result, in clinic only the parts with arterial blood flow and thin
tissue are used to place the sensor, such as fingers, toes and earlaps.
1) Movement. The measurement bases on the regular arterial pulse absorbing light signals. The
movement of the measured part will interfere with the extraction of the regular pulse signals,
which makes it impossible to process a measurement.
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F9 Series Fetal & maternal Monitor Service Manual
2) Weak perfusion. The patient’s badly blocked twig circle will result in the reduced arterial blood
flow in the measured part, which makes it impossible to process a measurement. Such as the
severe blood loss, low temperature at the measured part.
3) Optics interference. If there is strong light irradiating on the sensor, the photosensor’s work
might depart from the normal range, which will cause the inaccurateness of the measurement.
So avoid strong light when measuring.
The temperature sensor applies thermal resistor with negative temperature coefficient, whose
resistance changes with temperature.
Attentions
1) The temperature sensor can be placed at any place of the body. But due to the different
temperature of different part of a human being, the measured result indicates the temperature
of the human part where the sensor is placed, which might be different from that of the oral
cavity or underarm.
2) When measuring the temperature, it will take a few minutes for the sensor to bring into thermal
balance with the human body, so the temperature at the beginning is not the real temperature
of the measured part.
3) When measuring the temperature, make sure the sensor is firmly attached to the human body.
If the sensor is loose or there is space between the sensor and skin because of patient’s
movement, the result might be lower than real temperature.
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F9 Series Fetal & maternal Monitor Service Manual
Key Board
PS2 Port
LCDS
Main Control Board LCD Screen
Touch Screen
Print
Connecting Cable
Controlling
Board
Serial
Port
Power Module +12V,+5V Serial
Serial Port Port 485 Internet
Interface
Bottom Interfaces Board
Ethernet
DECG Module Ethernet
Serial Interface
Port USB
Serial
Port
Serial Serial USB Interface
Port Port Serial
Port
Fetal Monitor
NIBP Module SpO2 Module ECG Module
Module
S3C2410A
Work frequency: 266MHz / 200MHz
Processor External bus frequency: 1/2 or 1/4 of main frequency
Dictate Cache: 16K bytes
Data Cache: 16K bytes
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F9 Series Fetal & maternal Monitor Service Manual
GPIO At least 10
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F9 Series Fetal & maternal Monitor Service Manual
(1) ECG
Waveform 1 channel
Resolution 1 bpm
(2) TEMP
Channel Qty. 1
Resolution 0.1 ºC
25 ~ 45 ºC: ±0.1 ºC
Accuracy
0 ~ 25 ºC, 45 ~ 50 ºC: ±0.2 ºC
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F9 Series Fetal & maternal Monitor Service Manual
Method Oscillometric
The pulse extent of optical signal changes when measuring, SpO2 parameter, pulse rate signal and
pleth wave will be acquired after calculating. These data will be transmitted to the position
machine with special communication protocol. The specifications are listed as follows:
SpO2
Measurement & Alarm Range 0 ~ 100%
Resolution 1%
Accuracy + 2 (70% ~ 100%)
Pulse
Measurement & Alarm Range 30 bpm ~ 254 bpm
Resolution 1 bpm
Accuracy + 3 bpm; + 5 bpm (during movement)
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F9 Series Fetal & maternal Monitor Service Manual
The print controlling board is in charge of receiving data from main control board and driving the
thermosensitive print head to print. Its structure block diagram is as follows:
Parallel Port
Temperature Detect
Protecting
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.
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F9 Series Fetal & maternal Monitor Service Manual
The power interface board is used to transfer the power, its circuit is:
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F9 Series Fetal & maternal Monitor Service Manual
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.
J3 is input connects to the PS800B module in the machine.
C1, C2, C3 and C4 are Y capacitors, every capacitor resists 2300V voltage. Connecting a 10 Ω
resistor and two Y capacitors in series between L-PE and N-PE will improve the fetal heart and
data jumping problem when measuring FH with EFT.
When laying out the PCB of this board, the creepage distance between L, N and PE must not less
than 8mm, the distance between L and N must not less than 3mm.
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F9 Series Fetal & maternal Monitor Service Manual
Interface definition
(1) Interface connects to PS800B power module
Pin No. Symbol
1 VCC
2 GND
3 GND
4 GND
5 VDD
6 VEE
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F9 Series Fetal & maternal Monitor Service Manual
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F9 Series Fetal & maternal Monitor Service Manual
7.3 Interfaces
On the rear panel of the monitor, there are two interfaces and an antenna:
l DB 9 interface (RS232)
l RJ45 interface (NETWORK)
l Antenna
It is used to connect the monitor to a computer for monitoring information collection (with a
software such as Insight.), or to an obstetrical monitoring system such as MFM-CNS.
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F9 Series Fetal & maternal Monitor Service Manual
It is used to connect the monitor to a computer for updating or monitoring information collection
(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.
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F9 Series Fetal & maternal Monitor Service Manual
Chapter 8 Troubleshooting
This troubleshooting guide introduces the suitable actions for correcting the problems or
replacing the accessory or calling the service person. 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’ Malfunction Verification. When replacement is needed, follow the procedures
described in chapter 10 Dissembling the Monitor.
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F9 Series Fetal & maternal Monitor Service Manual
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F9 Series Fetal & maternal Monitor Service Manual
The alarm indicator stays Alarm indicator defective. Replace alarm indicator.
off. Alarm indicator board defective. Replace alarm indicator board.
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F9 Series Fetal & maternal Monitor Service Manual
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F9 Series Fetal & maternal Monitor Service Manual
NOTE: For all the interfaces, the first pin is the one with a square solder pad.
1) Open the main unit using the procedures described in section 11.3.
3) Using a multimeter, measure the voltage to earth of the pins listed below.
Item Pin Reference result
○
1 J8’s first pin VCC+5V (5.0V) ±5%
○
2 J31’s first pin VCC33(3.3V)±5%
○
3 TP1 +12V (12.0V) ±5%
○
4 TP2 PVCC(3.3V)±5%
○
5 C35’s positive pole VDDARM (1.9V) ±5%
○
6 C16’s positive pole VDDALIVE (1.9V) ±5%
○
7 J2’s first pin VBB33 (3.3V) ±5%
○
8 C59 VDD_RTC (1.8V) ±5%
○
9 C61 Li_BAT (≥2.75V)
○
3 TP1 ○
4 TP2
○
1 J8
○
5 C35
○
6 C16
○
7 J2
○
2 J31
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F9 Series Fetal & maternal Monitor Service Manual
C35 C16 J2
○
8 C59
○
9 C61
4) Compare the measurement results with the reference results in the list. If anyone of the
results exceeds the reference range, the main control board defection is confirmed.
Replacement of the main control board is recommended.
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F9 Series Fetal & maternal Monitor Service Manual
1) Open the main unit using the procedures described in section 11.3.
2) Using a multimeter, measure the voltage to earth of the pins listed below.
Item Pin Reference result
○
1 L16 +5V±10%
○
2 TP22 -5V±10%
○
3 TP18 +6.8V±10%
○
4 TP19 +6V±10%
○
5 TP10 +2.5V±10%
○
6 TP15 +3.3V±10%
○
7 TP20 +5V±10%
○
1 L16
FM Module PCBA
○
2 TP22
○
3 TP18
○
4 TP19
○
5 TP10
○
6 TP15
○
7 TP20
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F9 Series Fetal & maternal Monitor Service Manual
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.
Item Pin Reference result
○
10 TP9 0.9 V±20%
○
11 TP8 0.9 V±20%
○
12 TP11 3.30 V±20%
○
13 TP2 0.45 V±20%
○
14 TP4 0.40 V±20%
○
8 TP3
○
9 TP13
○
10 TP9
○
11 TP8
○
12 TP11
○
13 TP2
○
14 TP4
4) If anyone of the results exceeds the reference range, the FM module defection is confirmed.
Replacement of the module is recommended.
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F9 Series Fetal & maternal Monitor Service Manual
1) Open the main unit using the procedures described in section 11.3.
2) Disconnect the DECG cable connector from the bottom interfaces board.
4) Using a multimeter, measure the voltage to earth of the following pins of the bottom
interfaces board.
Item Pin Reference result
○
1 1st pin of J9 MB_RXD3
○
2 2nd pin of J9 MB_TXD3
○
3 5th pin of J9 +5V ±5%
J16 J9 J14
Bottom Interfaces Board
J15
J3
5) Use an oscillograph to measure the 1st pin of J9. A 0 ~5V pulse string signal should be
detected.
6) If all the results are in the reference range, reconnect the DECG cable and measure the
voltage to earth of the following pins on the DECG board.
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F9 Series Fetal & maternal Monitor Service Manual
DECG Board
○
4 TP7 ○
5 TP5 ○
6 TP6 ○
7 T1
7) Compare the measurement results with the reference results in the list. If anyone of the
results exceeds the reference range, the DECG module defection is confirmed. Replacement
of the module is recommended.
1) Make sure the malfunction of NIBP measurement is not caused by other defects, such as bad
connection or defective cuff, extension tube, main control board, etc.
2) Open the main unit using the procedures described in section 11.3.
3) Disconnect the NIBP cable connector from the bottom interfaces board.
5) Using a multimeter, measure the voltage to earth of the following pins of the bottom
interfaces board. (Refer to section 10.3 for J5’s location.)
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F9 Series Fetal & maternal Monitor Service Manual
○
3 6th pin of J5 +5V ±5%
th
○
4 7 pin of J5 +12V ±5%
6) Use an oscillograph to measure the 1st pin of J5. A 0 ~5V pulse string signal should be
detected.
7) If all the results are in the reference range, reconnect the NIBP plugs. Measure the following
pins on the NIBP board.
J4
8) If anyone of the results exceeds the reference range, the NIBP module defection is confirmed.
Replacement of the module is recommended.
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F9 Series Fetal & maternal Monitor Service Manual
1) Make sure the malfunction of SpO2 measurement is not caused by other defects, such as bad
connection or defective transducer, main control board, etc.
2) Open the main unit using the procedures described in section 11.3.
3) Disconnect the SpO2 cable connector from the bottom interfaces board.
5) Using a multimeter, measure the voltage to earth of the following pins of the bottom
interfaces board. (Refer to section 10.3 for J14’s location.)
○
3 4th pin of J14 MB_RXD4
○
4 5th, 6th pin of J14 +5V ±5%
6) Use an oscillograph to measure the 4th pin of J14. A 0 ~5V pulse string signal should be
detected.
7) If all the results are in the reference range, reconnect the SpO2 plugs. Measure the following
pins on the SpO2 board.
J2
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F9 Series Fetal & maternal Monitor Service Manual
8) If anyone of the results exceeds the reference range, the SpO2 module defection is confirmed.
Replacement of the module is recommended.
1) Make sure the malfunction of ECG measurement is not caused by other defects, such bad
connection or defective electrodes, main control board, etc.
2) Open the main unit using the procedures described in section 11.3.
3) Disconnect the ECG cable connector from the bottom interfaces board.
5) Using a multimeter, measure the voltage to earth of the following pins of the bottom
interfaces board. (Refer to section 10.3 for J16’s location.
○
3 4th pin of J 16 +5V ±5%
6) Using an oscillograph, measure the 1st pin of J16, a 0 ~5V pulse string signal should be
detected.
7) If all the results are in the reference range, reconnect the ECG plugs. Measure the following
pins on the ECG board.
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F9 Series Fetal & maternal Monitor Service Manual
J4
8) If all the results are in the reference range, the ECG module defection is confirmed.
Replacement of the module is recommended.
1) Open the main unit using the procedures described in section 11.3.
2) Disconnect the power board connector from the bottom interfaces board.
4) Using a multimeter, measure the voltage to earth of the following pins of the bottom
interfaces board. (Refer to section 10.3 for J3’s location.)
5) If anyone of the results exceeds the reference range, the power module defection is
confirmed. Replacement of the module is recommended.
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F9 Series Fetal & maternal Monitor Service Manual
Z Switch off the monitor and remove the AC power cable before disassemble the
monitor.
Z After any repair of the monitor, perform safety tests before using the monitor again.
1 – A cross-head screwdriver
2 – A flat-head screwdriver
3 – A M3 nut driver
4 – A pair of pliers
3) Carefully place the monitor upside down on a flat surface covered with cloth or other
protecting pad.
4) Place a flat-head screw driver in the gap of the fuse. Apply a certain amount of pressure on
the screw driver to sink the fuse for about 1 mm. Unscrew the fuse anticlockwise.
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F9 Series Fetal & maternal Monitor Service Manual
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.
Upper
assembly
Lower assembly
Screws
2) Carefully place the monitor upside down on a flat surface covered with cloth or other
protecting pad.
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F9 Series Fetal & maternal Monitor Service Manual
3) With a cross-head screw driver, remove the six screws securing the upper assembly to the
lower assembly.
4) Hold both upper and lower assemblies 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.
1 2 3 4 5 6
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F9 Series Fetal & maternal Monitor Service Manual
5) Replace the FM module in a reversal procedure. Refer to the following illustration when
connecting wires. Ensure they are all correctly connected.
(v) (vi) (vii)
No. Connect to
(i)
i Toco Socket
ii US2 Socket
iii US1 Socket
(ii) iv Mark Socket
v Speaker
vi Bottom Interfaces Board
vii Power Module
(iii)
(iv)
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F9 Series Fetal & maternal Monitor Service Manual
4) Replace the DECG module in a reversal procedure. Refer to the following illustration when
connecting wires. Ensure they are all correctly connected.
No. Connect to
4) Replace the print controlling board in a reversal procedure. Refer to the following illustration
when connecting wires. Ensure they are all correctly connected.
(i) (ii) (iii)
No. Connect to
i Paper Sensor
ii Paper Drawer
Detector
iii Bottom Interfaces
Board
iv Print head
(2 Sockets)
v Gear Assembly
(iv) (v)
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F9 Series Fetal & maternal Monitor Service Manual
4) Replace the gear assembly in a reversal procedure. Ensure the wires’ connector is correctly
connected to the print controlling board.
4) Replace the speaker in a reversal procedure. Ensure the wires’ connector is correctly
connected to the FM module.
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F9 Series Fetal & maternal Monitor Service Manual
4) Replace the power module in a reversal procedure. Refer to the following illustration when
connecting wires. Ensure they are all correctly connected.
No. Connect to
i FM module &
Bottom Interface
Board
ii Battery Interface
(i) Board
iii Power Switch
iv Bottom Interface
Board
v Power Interface
(ii)
Board
vi Green/Yellow
Ground Wire
(connects to
power interface
(iii) (iv) (v) (vi) board)
2) Unplug the fan wires connector from the power cable bundle.
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F9 Series Fetal & maternal Monitor Service Manual
4) Replace the fan in a reversal procedure. Ensure the wires’ connector is correctly connected to
connector on the power cable bundle.
2) Unplug the power wires connector from the power interface board. Using pliers to release the
ground wire.
4) Replace the power interface board in a reversal procedure. Ensure the wires are correctly
connected.
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F9 Series Fetal & maternal Monitor Service Manual
No. Connect to
(ii)
2) Disconnect the wire connecting the module to the bottom interfaces board. Detach the plastic
tube from the NIBP socket.
4) Replace the module in a reversal procedure. Ensure the wires are correctly connected.
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F9 Series Fetal & maternal Monitor Service Manual
4) Replace the SpO2 module in a reversal procedure. Refer to the following illustration when
connecting wires. Ensure they are all correctly connected.
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F9 Series Fetal & maternal Monitor Service Manual
No. Connect to
i SpO2 Socket
(i) ii Bottom Interface
Board
(ii)
4) Replace the ECG module in a reversal procedure. Refer to the following illustration when
connecting wires. Ensure they are all correctly connected.
(i)
No. Connect to
( ii )
( iii )
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F9 Series Fetal & maternal Monitor Service Manual
4) Replace the bottom interfaces board in a reversal procedure. Refer to the following
illustration when connecting wires. Ensure they are all correctly connected.
(vii) (vi) (v) (iv) (iii) ( ii) (i)
No. Connect to
i Network Wire
ii Power Control
Board
iii Battery
iv Signal Cable
v SpO2 Module
vi ECG Module
vii NIBP Module
viii FM Module
ix Print Control Board
x Power Board + Fan
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F9 Series Fetal & maternal Monitor Service Manual
4) Replace the main control board in a reversal procedure. Refer to the following illustration
when connecting wires. Ensure they are all correctly connected.
(vi) (v) (iv) (iii) (ii) (i)
No. Connect to
i Power Module
ii Key Board
iii Touch Screen
Control Board
iv Power Inverter
Board
v Network Socket
of Bottom
Interface Board
vi Alarm Indicator
vii LCD Assembly
(vii)
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F9 Series Fetal & maternal Monitor Service Manual
4) Replace the board in a reversal procedure. Refer to the following illustration when
connecting wires. Ensure they are all correctly connected.
No. Connect to
4) Replace the board in a reversal procedure. Refer to the following illustration when
connecting wires. Ensure they are all correctly connected.
(i) (ii) No. Connect to
4) Replace the board in a reversal procedure. Refer to the following illustration when
connecting wires. Ensure they are all correctly connected.
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F9 Series Fetal & maternal Monitor Service Manual
2) Disconnect the five wires from the power inverter board, main control board and touch
screen controlling board (shown with arrows).
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4) Place the upper assembly upright. Open the display assembly completely. Remove four
screws securing the display assembly stander.
5) Remove seven screws on the back of display assembly and the two roll shaft covers.
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F9 Series Fetal & maternal Monitor Service Manual
6) Pull out the wires then open the display assembly with care.
LCD
No. Connect to
iii
9) Replace the LCD in a reversal procedure. Refer to the following illustration when connecting
wires. Ensure they are all correctly connected.
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F9 Series Fetal & maternal Monitor Service Manual
Safety tests should be performed by qualified personnel once 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 60601-1 or
the local standards and statutes.
Refer to the accompanying operation instructions of the tester for test procedure details.
Ultrasound Transducer
3 Generate the heart rate 50 bpm, 90 bpm, 120 bpm, 150 bpm, 180 bpm and 210 bpm in
turn.
4 Check if the FHR value displayed on the screen is accurate. Error within 2 bpm is
acceptable.
5 Connect the ultrasound transducer to the other US socket and perform the same test.
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F9 Series Fetal & maternal Monitor Service Manual
TOCO Transducer
3 Press AUTO ZERO key to zero the system when no weight is added to the tray.
4 Add weights to the tray. Document the weights (W1, W2, W3, W4) when the TOCO value
reaches 25 (V1), 50 (V2), 75 (V3) and 100 (V4).
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F9 Series Monitor
3-Lead ECG Cable
ECG Emulator
3 Generate the heart rate 40 bpm, 80 bpm, 120 bpm, 160 bpm, 200 bpm and 240 bpm in
turn.
4 Check if the HR value displayed on the screen is accurate. Error within 2 bpm is
acceptable.
SpO2 Sensor
3 Generate the SpO2 signal 70%, 76%, 86%, 92%, 96% and 100% in turn.
4 Check if the SpO2 value displayed on the screen is accurate. Error within 2% is
acceptable.
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NIBP Cuff
2 Switch on the monitor.
3 Generate the NIBP signal 120/80 (93), 200/150 (166), 60/30 (40) and 80/50(60) in turn.
4 Check if the NIBP value displayed on the screen is accurate. Error within 8 mmHg is
acceptable.
4 The TEMP numeric value displayed on the screen correspond to 28 ºC, 37 ºC and 40 ºC.
Error within 0.2 ºC is acceptable.
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WARNING : Only connect the renewal parts supplied by EDAN to the monitor.
Speaker MS3-02251
Fan M17-47177
LCD M18-52161
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EDAN INSTRUMENTS, INC.
3/F-B, Nanshan Medical Equipments Park, Nanhai Rd 1019#, Shekou,
Nanshan Shenzhen, 518067 P.R. CHINA
TEL: +86-755-26882220 FAX: +86-755-26882223
EC REPRESENTATIVE