EDAN F15 Series User manual

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About this Manual
P/N: 01.54.458569
Version: 1.0
MPN: 01.54.458569010
Release Date: Sep. 2020
© Copyright EDAN INSTRUMENTS, INC. 2020. 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.
EDAN will make available on request circuit diagrams, component part lists, descriptions,
calibration instructions, or other information that will assist SERVICE PERSONNEL to repair
those parts of ME EQUIPMENT that are designated by EDAN as repairable by SERVICE
PERSONNEL.
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

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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.

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Content
Chapter 1 Safety Guidance ..............................................................................................................................7
1.1 Introduction................................................................................................................................................. 7
1.2 General Information .................................................................................................................................... 7
1.3 Safety Precautions.......................................................................................................................................8
1.4 Definitions and Symbols ............................................................................................................................. 1
Chapter 2 Installation.......................................................................................................................................5
2.1 Environmental Requirements......................................................................................................................5
2.2 Electrical Requirements............................................................................................................................... 6
2.3 Safety Requirements.................................................................................................................................... 6
2.4 Installing the Monitor.................................................................................................................................. 6
2.4.1 Installing the Monitor on a Flat Surface............................................................................................... 6
2.4.2 Mounting the Monitor on a Wall.......................................................................................................... 7
2.4.3 Installing the Monitor on Trolley.......................................................................................................... 8
2.5 Connecting to AC Power............................................................................................................................. 9
Chapter 3 Functional Checks.........................................................................................................................10
3.1 Switching on Check................................................................................................................................... 10
3.2 LCD Screen Check.................................................................................................................................... 10
3.3 Touch Screen Check.................................................................................................................................. 10
3.4 Printing Check........................................................................................................................................... 11
3.5 Alarms Check ............................................................................................................................................ 11
Chapter 4 System Configuration...................................................................................................................12
4.1 Opening System Setup Menu.................................................................................................................... 12
4.2 Entering Demo Mode................................................................................................................................12
4.3 Reloading Default Settings........................................................................................................................ 12
4.4 Clearing Data............................................................................................................................................. 13
4.5 Checking Product Information.................................................................................................................. 13
4.6 Calibrating Touch Screen .......................................................................................................................... 13
4.7 Changing the Device No. ..........................................................................................................................14
4.8 Changing Net Version................................................................................................................................ 14
4.9 Configuring 485 Wireless Network........................................................................................................... 14
4.10 Configuring for Ethernet Connecting...................................................................................................... 15
4.11 Changing Trace Width............................................................................................................................. 16
4.12 Changing Paper Style .............................................................................................................................. 16
4.13 Changing the Language........................................................................................................................... 16
4.14 Changing FHRAlgorithm ....................................................................................................................... 17
4.15 Pressure Verification................................................................................................................................ 17
4.16 NIBP Leak Test........................................................................................................................................ 17
4.17 NIBP Calibration..................................................................................................................................... 17
Chapter 5 Maintenance ..................................................................................................................................19
5.1 Maintenance Inspection............................................................................................................................. 19
5.2 Maintenance of the Monitor...................................................................................................................... 19
5.3 Maintenance of the Transducers................................................................................................................ 20
5.4 Maintenance of the Recorder..................................................................................................................... 20
Chapter 6 Principle Introduction .................................................................................................................. 21
6.1 System Principle Block Diagram .............................................................................................................. 21
6.1.1 Main Control Board............................................................................................................................ 22
6.1.2 Bottom Interface Board...................................................................................................................... 23
6.1.3 AC-DC Power Board.......................................................................................................................... 24
6.1.4 DC-DC Transfer Board....................................................................................................................... 25
6.1.5 iM X12 Parameter Board（wired model only）................................................................................ 26

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6.1.6 Edan Transducer Socket Board (wired model only)........................................................................... 28
6.1.7 NELLTransducer Socket Board (wired model only)......................................................................... 28
6.1.8 Wireless Charging Board (wireless model only)................................................................................ 29
6.2 Interface..................................................................................................................................................... 30
6.2.1 DB15 Interface ................................................................................................................................... 30
6.2.2 Antenna............................................................................................................................................... 30
6.2.3 RJ45 Interface..................................................................................................................................... 30
6.2.4 HDMI Interface .................................................................................................................................. 31
Chapter 7 Troubleshooting.............................................................................................................................32
7.1 Monitor Booting Failures.......................................................................................................................... 32
7.2 Display Failures......................................................................................................................................... 32
7.3 Touch Screen Failures ............................................................................................................................... 33
7.4 Sound Failures........................................................................................................................................... 33
7.5 Recorder Failures.......................................................................................................................................33
7.6 Network Failures....................................................................................................................................... 34
7.7 Alarm Failures........................................................................................................................................... 34
7.8 Alarm Failures........................................................................................................................................... 35
7.9 FHR/TOCO Monitoring Failures .............................................................................................................. 35
7.10 ECG Monitoring Failures........................................................................................................................ 35
7.11 SpO2 Monitoring Failures....................................................................................................................... 36
7.12 NIBP Monitoring Failures....................................................................................................................... 36
7.13 TEMP Monitoring Failures...................................................................................................................... 37
Chapter 8 Modules’ Malfunction Verification.............................................................................................. 38
8.1 Verifying Malfunction of the Main Control Board.................................................................................... 38
8.2 Verifying Malfunction of the iM X12 Parameter board.............................................................................42
8.3 Verifying Malfunction of Lower Case Interface Board............................................................................. 43
8.4 Verifying Malfunction of AC-DC Power Board........................................................................................ 44
8.5 Verifying Malfunction of EDAN Transducer Socket Board (wired model only)...................................... 45
8.6 Verifying Malfunction of NELLTransducer Socket Board (wired model only)....................................... 46
8.7 Verifying Malfunction of Wireless Charging Board.................................................................................. 46
Chapter 9 Disassembling the Monitor........................................................................................................... 48
9.1 Tools Required........................................................................................................................................... 48
9.3 Disassembling the Main Unit.................................................................................................................... 48
9.4 Disassembling the Lower assembly ..........................................................................................................50
9.4.1 Replacing the DC-DC Transfer Board................................................................................................ 50
9.4.2 Replacing the Fan............................................................................................................................... 51
9.4.3 Replacing the Power Module ............................................................................................................. 52
9.4.4 Replacing the WIFI Module............................................................................................................... 53
9.4.5 Replacing the Main Control Board..................................................................................................... 53
9.4.6 Replacing the iM X12 Parameter Board (wired model only)............................................................. 54
9.4.7 Replacing the Loudspeaker ................................................................................................................ 55
9.4.8 Replacing the Transducer Socket Board (wired model only)............................................................. 56
9.4.9 Replacing the Bottom Interface Board............................................................................................... 56
9.4.10 Replacing the Printhead.................................................................................................................... 57
9.4.11 Replacing theAP Module (wireless model only) ............................................................................. 58
9.4.12 Replacing the Wireless Transducer Bracket (wireless model only).................................................. 58
9.5 Disassembling the UpperAssembly.......................................................................................................... 59
9.5.1 Replacing the LCD Assembly ............................................................................................................ 59
Chapter 10 Periodic Tests.................................................................................................................................60
10.1 Safety Tests.............................................................................................................................................. 60
10.2 Performance Tests.................................................................................................................................... 60
10.2.1 FHR Performance Test .....................................................................................................................60
10.2.2 TOCO Performance Test................................................................................................................... 61
10.2.3 ECG Performance Test ..................................................................................................................... 61

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10.2.4 SpO2 Performance Test.................................................................................................................... 62
10.2.5 NIBP Performance Test .................................................................................................................... 62
10.2.6 TEMP Performance Test................................................................................................................... 62
10.2.7 FECG Performance Test（Wireless Model Only）......................................................................... 63
Appendix 1 Renewal Parts................................................................................................................................ 65
Appendix 2 Connecting to OB TraceVue System............................................................................................66

F15 Series Fetal & Maternal Monitor Service Manual Safety Guidance
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Chapter 1Safety Guidance
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.
1.1 Introduction
This service manual is a reference for periodic preventive maintenance and corrective service
procedures for the F15 and F15 Air 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.
1.2 General Information
NOTE:
In this manual, Monitor refers to both F15 and F15 air, and is used where the information
applies to both models.
The monitor is designed to comply with the international safety requirements IEC/EN
60601-1 for medical electrical equipment. It is class I equipment.
The monitor operates within specifications at ambient temperatures between 0ºC (+41 ºF)
and +40 ºC (+104 ºF). Ambient temperatures that exceed these limits could affect the
accuracy of the instrument and cause damage to the modules and circuits. Allow at least 2
inches (5 cm) clearance around the instrument for proper air circulation.
You must check that the equipment, cables and transducers do not have visible evidence of
damage that may affect patient safety or monitoring capability before each use. If damage is
evident, replacement is recommended before use.
The monitor must be serviced only by authorized and qualified personnel. The manufacturer

F15 Series Fetal & Maternal Monitor Service Manual Safety Guidance
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does not accept responsibility for safety compliance, reliability and performance if
modifications or repairs are carried out by unauthorized personnel. Identical replacement
parts must be used.
The typical operator's position is in front of the monitor. Please position the device in a
location where the operator can easily see the screen and access the operating controls.
The protective degree against electric shock of the patient connections is:
Ultrasound (FHR1, FHR2, FHR3)
External TOCO
Fetal Movement Mark (FM)
Fetal Stimulator (FS)
Intrauterine Pressure (IUP)
Maternal Electrocardiography (MECG)
Direct Electrocardiography(DECG)
Fetal Electrocardiography (FECG)
Type CF
Non-invasive Blood Pressure (NIBP)
Arterial Oxygen Saturation (SpO2)
Temperature (TEMP)
Type CF, defibrillation-proof
The monitor described in this service manual is not protected against:
a) The effects of high frequency currents
b) The interference of electrosurgery equipment
1.3 Safety Precautions
WARNING and CAUTION messages must be observed. To avoid the possibility of injury,
observe the following precautions during the maintaining the instrument.

F15 Series Fetal & Maternal Monitor Service Manual Safety Guidance
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WARNING
1 The monitor must be serviced by authorized and qualified personnel only. EDAN do
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
User Manual of the monitor for details.
3 EXPLOSION HAZARD - Do not use the monitor in the presence of flammable
anesthetics or other materials.
4 SHOCK HAZARD - the power receptacle must be a three-wire grounded outlet.
Never try to adapt the three-prong plug to fit a two-slot outlet. A hospital grade outlet
is required. 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.
5 Any non-medical equipment (such as the external printer) is not allowed to be used
within the patient vicinity (1.5m/6ft.).
6 Do not use the additional multiple portable socket-outlet or extension cord in the
medical electrical system, unless it’s specified as part of the system by manufacturer.
And the multiple portable socket-outlets provided with the system shall only be used
for supplying power to equipment which is intended to form part of the system.
7 If multiple instruments are connected to a patient, the sum of the leakage currents
may exceed the limits given in the IEC/EN 60601-1 and may pose a safety hazard.
Consult your service personnel.
8 Multiple portable socket-outlets shall not be placed on the floor.
9 Make sure that the power is turned off and the power cord is disconnected from the
AC socket before connecting or disconnecting equipment. Otherwise, the patient or
operator may receive electrical shock or other injury.
10 Do not connect any equipment or accessories that are not approved by the
manufacturer or that are not IEC 60601-1 approved to the monitor. The operation or
use of non-approved equipment or accessories with the monitor is not tested or
supported, and monitor operation and safety are not guaranteed.
11 SHOCK HAZARD - Don’t connect non-medical electrical equipment, which has been
supplied as a part of the system, directly to the wall outlet when the non-medical
equipment is intended to be supplied by a multiple portable socket-outlet with an
isolation transformer.

F15 Series Fetal & Maternal Monitor Service Manual Safety Guidance
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WARNING
12 SHOCK HAZARD - Don’t connect electrical equipment, which has not been supplied
as a part of the system, to the multiple portable socket-outlets supplying the system.
13 Do not use the additional multiple portable socket-outlet or extension cord in the
medical electrical system, unless it’s specified as part of the system by manufacturer.
And the multiple portable socket-outlets provided with the system shall only be used
for supplying power to equipment which is intended to form part of the system.
14 Do not exceed the maximum permitted load when using multiple portable
socket-outlets to supply the system.
15 Do not touch accessible parts of non-medical electrical equipment and the patient
simultaneously.
16 Do not switch on the monitor until all cables have been properly connected and
verified.
17 Do not touch the signal input or output connector and the patient simultaneously.
18 Equipment and devices that connect to the monitor should form an equipotential body
to ensure effective grounding.
19 Disconnect the power cord before changing fuses. Replace them with those of the
same specifications only.
20 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.
21 SHOCK HAZARD - Do not remove the top panel cover during operation or while
power is connected.
22 Only connect accessories supplied or recommended by the manufacturer to the
device.
23 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. Anybody who connects additional equipment to the signal input connector
or signal output connector to configure a medical system must ensure that the system
complies with the requirements of the valid version of the system standard IEC/EN
60601-1. If in doubt, consult our technical service department or your local distributor.

F15 Series Fetal & Maternal Monitor Service Manual Safety Guidance
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WARNING
24 Parts and accessories used must meet the requirements of the applicable IEC 601
series safety standards, and/or the system configuration must meet the requirements
of the IEC 60601-1 medical electrical systems standard.
25 Connect the grounding wire to the equipotential grounding terminal in the main
system. If it is not evident from the instrument specifications whether a particular
instrument combination is hazardous or not, for example due to summation of
leakage currents, you should consult the manufacturer or an expert in the field, to
ensure that the necessary safety of all instruments concerned will not be impaired by
the proposed combination.
26 Electromagnetic Interference - Ensure that the environment in which the monitor is
installed is not subject to any source of strong electromagnetic interference, such as
CT, radio transmitters, mobile phone base stations, etc.
27 When installing the unit into a cabinet, allow for adequate ventilation, accessibility for
servicing, and room for adequate visualization and operation.
28 Keep the environment clean. Avoid vibration. Keep it far from corrosive medicine,
dust area, high-temperature and humid environment.

F15 Series Fetal & Maternal Monitor Service Manual Safety Guidance
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1.4 Definitions and Symbols
F15 Series Fetal & Maternal Monitor
1
Fetal monitoring socket, ultrasound transducers, TOCO
transducer and Fetal&Maternal Module can be connected to
it( Type CF applied part)
2
Socket for Remote Event Marker ( Type CF applied part)
3
Socket for Fetal Stimulator ( Type CF applied part)
4
Socket for ECG cable ( Type CF applied part)
5
TEMP
Socket for TEMP Transducer ( Type CF applied part)
6
NIBP
Socket for NIBP Cuff ( Type CF applied part)
7
SpO2
(EDAN)
Socket for SpO2Transducer ( Type CF applied part)
8
SPO2
（Nellcor）
Socket for SpO2Transducer ( Type CF applied part)
9
DB9 interface
10
RJ45 Interface
11
Battery check

F15 Series Fetal & Maternal Monitor Service Manual Safety Guidance
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12
Alternating Current
13
Direct Current
14
Stand-by
15
Power Supply switch
16
Warning
(Background: Yellow; Symbol & outline: Black)
17
Caution
18
Operating instructions
19
Refer to User Manual
(Background: Blue; Symbol: White)
20
TYPE CF APPLIED PART
21
DEFIBRILLATION-PROOF TYPE CF APPLIED PART
22
IP68
Dust-tight and protected against the effects of continuous
immersion in water
23
IPX2
Protected against vertically falling water drops when enclosure
tilted up to 15o
24
CE marking
25
General symbol for recovery/recyclable
26
Part Number
27
Date Of Manufacture

F15 Series Fetal & Maternal Monitor Service Manual Safety Guidance
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28
Manufacturer
29
AUTHORISED REPRESENTATIVE IN THE EUROPEAN
COMMUNITY
30
Disposal method
31
Non-ionizing electromagnetic radiation
32
USB Port
33
Ethernet Port
34
Serial Number
35
Catalogue number
36
Federal (U.S.) Law restricts this device to sale by or on the order
of a physician
37
This way up
38
Fragile, handle with care
39
Keep dry
40
STACKING LIMIT BY NUMBER
41
HANDLE WITH CARE

F15 Series Fetal & Maternal Monitor Service Manual Safety Guidance
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42
DO NOT STEP ON

F15 Series Fetal & Maternal Monitor Service Manual Installation
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Chapter 2 Installation
WARNING
The system installation should be operated by serviceman authorized by the manufacturer.
2.1 Environmental Requirements
Working Environment
Temperature:
0 ºC ~ + 40 ºC ( +32 ºF ~ +104 ºF)
Relative Humidity:
15% ~ 95% (non-condensing)
Atmospheric Pressure:
86 kPa ~ 106 kPa
Transport and Storage
Temperature:
-20 ºC ~ +55 ºC (-4ºF ~ +131 ºF)
Relative Humidity:
15% ~ 93% (non-condensing)
Atmospheric Pressure:
70 kPa ~ 106 kPa
Classification
Anti-electric Shock Type:
Class I equipment with internal power supply
Anti-electric Shock Degree:
MECG,FHR1,FHR2,FHR3
,TOCO,MARK,EXT.1,
DECG, IUP,FECG
CF
SpO2, NIBP , TEMP
CF (Defibrillating-proof)
Degree of Protection against
Harmful Ingress of Water:
Main Unit:
IPX2, protected against vertically falling water drops
when enclosure tilted up to 15o (provided recorder
drawer is shut and the monitor is not mounted on the
wall vertically)
US/TOCO/Fetal&Maternal Modules: IP68, dust-tight
and protected against the effects of continuous emersion
in water
FT20 Telemetry Transmitter: IPX2
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

F15 Series Fetal & Maternal Monitor Service Manual Installation
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EMC:
Group I Class A
Working System
Continuous running equipment
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 subject 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.
2.2 Electrical Requirements
Operating Voltage:
Operating Frequency:
Input Power:
Battery:
100V-240V ~
50Hz/60Hz
110VA
10.8VDC/5100mAh
2.3 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.
2.4 Installing the Monitor
2.4.1 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.

F15 Series Fetal & Maternal Monitor Service Manual Installation
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2.4.2 Mounting the Monitor on a Wall
CAUTION
1 The monitor should only be mounted on a solid concrete or brick wall.
2 Shut the display completely flat before mounting the monitor to the wall.
3 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.
4 Make sure the monitor is safely hung on the posts of the board before releasing your
hands from the monitor.
To mount the monitor on a wall,
1Order a wall mounting board (01.52.107983), a retaining board (01.52.01983) and a
connecting board (01.52.107984) from the manufacturer.
2Turn the monitor over and fix the retaining board to the bottom panel using six pan head
screws and then fix the connecting board to the retaining board with two pan head
screws.
Figure 2-1 Fixing Retaining Board and Connecting Board
3Fix the wall mounting board to the wall with six self-tapping screws.

F15 Series Fetal & Maternal Monitor Service Manual Installation
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Figure 2-2 Fixing Wall Mounting Board
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.
2.4.3 Installing the Monitor on Trolley
An Assembling Instruction will be delivered with the trolley. Refer to that instruction for details
of installing the monitor on a trolley.
Wall
Wall Mounting
Board

F15 Series Fetal & Maternal Monitor Service Manual Installation
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Figure 2-3 the Monitor on a Trolley (Sketch Map)
2.5 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.