EDAN F9 Express User manual

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

I
About this Manual
P/N: 01.54.107779
Version 2.9
MPN: 01.54.107779029
Release Date: Sep. 2018
© Copyright EDAN INSTRUMENTS, INC. 2008 - 2018. 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.
Terms Used in this Manual
This guide is designed to give key concepts on safety precautions.
WARNING

II
A WARNING label advises against certain actions or situations that could result in personal
injury or death.
CAUTION
A CAUTION label advises against actions or situations that could damage equipment, produce
inaccurate data, or invalidate a procedure.
NOTE
A NOTE provides useful information regarding a function or a procedure.

III
Table of Contents
Chapter 1 Safety Guidance ...........................................................................................................1
1.1 Intended Use/Indications for Use...........................................................................................1
1.2 Features...................................................................................................................................2
1.3 Instruction for Safe Operation................................................................................................2
1.4 Ultrasound Safety Guide ........................................................................................................3
1.5 Safety Precautions ..................................................................................................................4
1.6 Definitions and Symbols ...................................................................................................... 11
Chapter 2 Introducing the Monitor ...........................................................................................15
2.1 Installation Guide .................................................................................................................15
2.1.1 Opening the Package and Checking...............................................................................15
2.1.2 Installing Battery............................................................................................................15
2.1.3 Installing Monitor ..........................................................................................................17
2.1.4 Connecting Power Cable................................................................................................17
2.2 Overview ..............................................................................................................................18
2.2.1 Keys ...............................................................................................................................20
2.2.2 Indicators........................................................................................................................22
2.3 Accessories ...........................................................................................................................22
2.3.1 Ultrasound (US) Transducers.........................................................................................23
2.3.2 TOCO Transducers.........................................................................................................23
2.3.3 Belt.................................................................................................................................23
2.3.4 Remote Event Marker....................................................................................................24
2.3.5 Fetal Stimulator..............................................................................................................24
2.3.6 DECG Cable ..................................................................................................................25
2.3.7 Fetal Spiral Electrode.....................................................................................................25
2.3.8 IUP Cable.......................................................................................................................25
2.3.9 IUP Catheter...................................................................................................................26
2.3.10 ECG Cable ...................................................................................................................26
2.3.11 SpO2Sensor..................................................................................................................26
2.3.12 NIBP Cuff ....................................................................................................................27
2.3.13 TEMP Sensor ...............................................................................................................27
2.4 Screen ...................................................................................................................................28
2.4.1 Main Interface................................................................................................................28
2.4.2 Setup Interface ...............................................................................................................31
2.4.3 Touch Screen..................................................................................................................32
Chapter 3 Introducing the FTS-3 Fetal Telemetry System......................................................34
3.1 Brief Introduction.................................................................................................................34
3.1.1 Base Station....................................................................................................................35
3.1.2 Transducers ....................................................................................................................38
3.1.3 Accessories.....................................................................................................................39
3.1.4 Features..........................................................................................................................40
3.2 Installation Guide .................................................................................................................40

IV
3.2.1 Opening the Package and Checking...............................................................................40
3.2.2 Installing Battery............................................................................................................41
3.2.3 Installing the System......................................................................................................43
3.2.4 Connecting Power Cable................................................................................................43
3.2.5 Configuration .................................................................................................................44
3.2.6 Connecting to the Monitor.............................................................................................44
3.2.7 Adjusting the Working Channel.....................................................................................44
3.3 Basic Operation ....................................................................................................................45
3.3.1 Charge the Transducer....................................................................................................45
3.3.2 Charge the Battery..........................................................................................................45
3.3.3 General Application .......................................................................................................47
3.3.4 Relocation of the Transducers........................................................................................48
3.3.5 Monitor the Ambulatory Patient.....................................................................................48
3.3.6 Underwater Monitoring..................................................................................................49
3.3.7 Priority ...........................................................................................................................50
3.3.8 Basic Function Test........................................................................................................50
Chapter 4 Alarms.........................................................................................................................52
4.1 Alarm Classification.............................................................................................................52
4.2 Audible Alarm.......................................................................................................................52
4.3 Visual Alarm.........................................................................................................................53
4.4 Choosing the Alarm Display Form.......................................................................................54
4.5 Changing the Alarm Volume ................................................................................................54
4.6 *Choosing Alarm Silence Duration......................................................................................54
4.7 Choosing Signal Loss Delay.................................................................................................55
4.8 Pausing or Resetting the Alarm ............................................................................................55
4.9 Switching Transducer Unplugged On or Off........................................................................55
4.10 *Reviewing Alarms ............................................................................................................55
4.11 Alarm Treatment Measures.................................................................................................56
4.12 Testing Alarms....................................................................................................................57
4.13 Patient Alarm Defaults........................................................................................................57
4.14 Alarm Messages..................................................................................................................59
4.14.1 Fetal Monitoring Alarm Messages...............................................................................59
4.14.2 Maternal Monitoring Alarm Messages ........................................................................61
4.14.3 FTS-3 Technical Alarm Messages................................................................................64
4.14.4 Alarm Bilateral Control................................................................................................64
Chapter 5 Printing .......................................................................................................................66
5.1 *Function Description ..........................................................................................................66
5.2 Printing Configuration..........................................................................................................67
5.2.1 Switching Auto Start Printing On or Off........................................................................67
5.2.2 *Choosing the Paper Speed............................................................................................67
5.2.3 *Changing the Print Timer.............................................................................................67
5.2.4 Switching Print Self-Check On or Off...........................................................................68
5.2.5 Changing Printing End Volume......................................................................................68

V
5.2.6 Changing Title Print Cycle.............................................................................................68
5.2.7 Switching Maternal Monitor Information On or Off.....................................................68
5.3 Understanding Recorder Paper Printout...............................................................................69
Chapter 6 Pre-Monitoring Preparation.....................................................................................71
6.1 Loading Recorder paper .......................................................................................................71
6.2 Switching On the Monitor....................................................................................................73
6.3 Checking the Recorder Paper...............................................................................................73
6.4 Adjusting the Screen Angle ..................................................................................................74
6.5 Setting Date and Time ..........................................................................................................75
6.6 Connecting Transducers .......................................................................................................76
6.7 Placing Accessories in the Holder........................................................................................76
6.8 Adjusting the Volume ...........................................................................................................77
Chapter 7 Fetal Monitoring ........................................................................................................79
7.1 Confirming Fetal Life...........................................................................................................79
7.2 Monitoring FHR with Ultrasound ........................................................................................79
7.2.1 Monitoring FHR with Wired Ultrasound Transducer ....................................................80
7.2.2 Monitoring FHR with Wireless Ultrasound Transducer ................................................82
7.2.3 Switching the FHR Alarm On or Off.............................................................................82
7.2.4 Changing the FHR Alarm Limits...................................................................................83
7.2.5 Changing the FHR Alarm Delay....................................................................................83
7.2.6 Testing US Transducers..................................................................................................84
7.3 Monitoring FHR with DECG...............................................................................................85
7.3.1 Contraindications ...........................................................................................................85
7.3.2 Preparing the Patient's Skin Prior to Placing Electrodes................................................85
7.3.3 Directions for Using Fetal Spiral Electrode...................................................................85
7.3.4 Wired DECG Monitoring...............................................................................................86
7.3.5 Wireless DECG Monitoring...........................................................................................87
7.3.6 Changing DECG Beep Volume......................................................................................88
7.3.7 DECG Gain and Display................................................................................................89
7.3.8 Switching the Artifact Suppression On or Off...............................................................89
7.3.9 Detaching the Fetal Spiral Electrode..............................................................................89
7.4 Monitoring Twin FHRs.........................................................................................................90
7.4.1 Monitoring Twins Externally.........................................................................................90
7.4.2 Monitoring Internally.....................................................................................................90
7.4.3 Signals Overlap Verification (SOV)...............................................................................90
7.4.4 Changing FHR2 Offset ..................................................................................................90
7.5 Monitoring Uterine Activity Externally ...............................................................................91
7.5.1 Wired TOCO Monitoring...............................................................................................91
7.5.2 Wireless TOCO Monitoring...........................................................................................92
7.5.3 Changing the UA Baseline.............................................................................................93
7.5.4 Testing TOCO Transducers............................................................................................93
7.6 Monitoring Uterine Activity Internally.................................................................................94
7.6.1 Parts Required................................................................................................................94
7.6.2 Directions for Use of IUPC............................................................................................94

VI
7.6.3 IUP Monitoring Procedure.............................................................................................96
7.6.4 Checking Intrauterine Pressure Cable Function.............................................................97
7.7 Monitoring Fetal Movement.................................................................................................97
7.7.1 Auto Fetal Movement (AFM) Monitoring.....................................................................97
7.7.2 Enabling or Disabling AFM Monitoring........................................................................98
7.7.3 Choosing AFM Mode.....................................................................................................98
7.7.4 Choosing FM Source .....................................................................................................98
7.7.5 Manual Fetal Movement (MFM) Monitoring................................................................98
7.7.6 Changing MFM Volume.................................................................................................99
7.8 *Start Monitoring .................................................................................................................99
7.9 *Inputting Maternal Information (Mat. Info).......................................................................99
7.9.1 Auto ID...........................................................................................................................99
7.9.2 Changing Maternal Information.....................................................................................99
7.9.3 Switching Mat. Info Inputting On or Off.....................................................................100
Chapter 8 Fetal Monitoring Display (F9) ................................................................................102
8.1 Traces..................................................................................................................................102
8.1.1 Changing Time Scale ...................................................................................................104
8.2 Trace Control Tools ............................................................................................................104
8.2.1 Data Saving..................................................................................................................105
8.2.2 *Searching for a File....................................................................................................105
8.2.3 File Management (Optional)........................................................................................106
8.2.4 *Reviewing ..................................................................................................................108
8.2.5 *CTG Analysis.............................................................................................................109
8.2.6 *Marking a Note .......................................................................................................... 111
8.3 Numerics............................................................................................................................. 112
8.3.1 Changing Numeric Window Position (F9)................................................................... 113
Chapter 9 Maternal Monitoring (F9 Express) ........................................................................114
9.1 Maternal ECG Monitoring..................................................................................................114
9.1.1 Introduction..................................................................................................................114
9.1.2 How to Place 3-lead ECG Cables ................................................................................115
9.1.3 How to Place 2-lead FTS-3 MECG Cables .................................................................116
9.1.4 Wired ECG Monitoring................................................................................................ 118
9.1.5 Wireless ECG Monitoring............................................................................................ 118
9.1.6 Changing ECG Source.................................................................................................119
9.1.7 Changing ECG Gain ....................................................................................................119
9.1.8 Enabling ECG Calibration ........................................................................................... 119
9.2 Maternal SpO2Monitoring.................................................................................................120
9.2.1 Introduction..................................................................................................................120
9.2.2 SpO2Monitoring Procedure.........................................................................................123
9.2.3 Enabling SpO2Trace Printing......................................................................................123
9.2.4 Assessing the Validity of a SpO2 Reading...................................................................124
9.2.5 SI (Signal Intensity)* ...................................................................................................124
9.2.6 Switching the SpO2Alarm On or Off ..........................................................................125
9.2.7 Changing SpO2Alarm Limits ......................................................................................125
9.3 Maternal HR Monitoring....................................................................................................125
9.3.1 Introduction..................................................................................................................125

VII
9.3.2 Choosing HR Source....................................................................................................125
9.3.3 Changing HR Beep Volume.........................................................................................126
9.3.4 Enabling HR Trace.......................................................................................................126
9.3.5 Switching the HR Alarm On or Off .............................................................................126
9.3.6 Changing HR Alarm Limits.........................................................................................127
9.3.7 Signals Overlap Verification ........................................................................................127
9.4 Maternal NIBP Monitoring.................................................................................................127
9.4.1 Introduction..................................................................................................................127
9.4.2 How to Apply NIBP Cuff.............................................................................................129
9.4.3 Preparation for NIBP Monitoring ................................................................................130
9.4.4 *Auto Measurement.....................................................................................................131
9.4.5 *Manual Measurement.................................................................................................131
9.4.6 Correcting the Measurement........................................................................................132
9.4.7 Changing NIBP Unit....................................................................................................132
9.4.8 Switching the NIBPAlarm On or Off..........................................................................133
9.4.9 Changing SYS Alarm Limits .......................................................................................133
9.4.10 Changing DIAAlarm Limits......................................................................................133
9.4.11 Changing MAPAlarm Limits ....................................................................................134
9.4.12 *Choosing NIBP Printing Mode ................................................................................134
9.4.13 *Calibrating NIBP......................................................................................................134
9.5 Maternal TEMP Monitoring...............................................................................................135
9.5.1 TEMP Monitoring Procedure.......................................................................................135
9.5.2 Changing TEMP Unit...................................................................................................135
9.5.3 Switching the TEMPAlarm On or Off ........................................................................136
9.5.4 Changing TEMP Alarm Limits ....................................................................................136
Chapter 10 Maternal Monitoring Display (F9 Express) ........................................................137
10.1 *Display Mode .................................................................................................................137
10.2 Maternal Monitoring Traces.............................................................................................140
10.3 Maternal Vital Sign List ...................................................................................................140
10.4 Numerics...........................................................................................................................141
Chapter 11 After Monitoring....................................................................................................145
11.1 Completing Monitoring ....................................................................................................145
11.2 Switching Off....................................................................................................................145
Chapter 12 Maintenance and Cleaning ...................................................................................146
12.1 Maintenance......................................................................................................................146
12.1.1 Maintaining Inspection ..............................................................................................146
12.1.2 Maintenance of Monitor and Base Station.................................................................147
12.1.3 Maintenance of Wired and Wireless Transducers......................................................147
12.1.4 Storage of Recorder Paper .........................................................................................147
12.1.5 Cleaning of Recorder .................................................................................................148
12.1.6 Maintaining the Battery .............................................................................................148
12.2 Cleaning............................................................................................................................148
12.2.1 Cleaning of Monitor and Base Station.......................................................................148
12.2.2 Cleaning of Accessories.............................................................................................149
12.3 Disinfecting ......................................................................................................................151

VIII
12.4 Sterilizing..........................................................................................................................152
Chapter 13 Warranty and Service............................................................................................153
13.1 Warranty ...........................................................................................................................153
13.2 Contact information..........................................................................................................153
Appendix 1 Product Specifications...........................................................................................154
A F9, F9 Express Fetal/Maternal Monitor................................................................................154
A1.1 Environmental Specifications ......................................................................................154
A1.2 Physical Specifications.................................................................................................154
A1.3 Performance Specifications..........................................................................................156
A1.4 Recorder Specifications ...............................................................................................161
A1.5 Rechargeable Lithium-ion Battery...............................................................................162
A1.6 Low Output Summary Table........................................................................................162
B FTS-3 Fetal Telemetry System .............................................................................................163
B1.1 Environmental Specifications.......................................................................................163
B1.2 Physical Specifications.................................................................................................163
B1.3 Performance Specifications..........................................................................................165
B1.4 Rechargeable Lithium-ion Battery ...............................................................................168
B1.5 Low Output Summary Table ........................................................................................168
Appendix 2 Signal Input/ Output Connector..........................................................................170
Appendix 3 Troubleshooting.....................................................................................................172
A F9, F9 Express Fetal/Maternal Monitor................................................................................172
A3.1 No Display ...................................................................................................................172
A3.2 Noise ............................................................................................................................172
A3.3 Recorder Error..............................................................................................................172
A3.4 Trouble with Ultrasound FHR Monitoring ..................................................................173
A3.5 Troubles with DECG Monitoring.................................................................................173
A3.6 Troubles with Contractions Monitoring (External)......................................................174
A3.7 Troubles with Contractions Monitoring (Internal).......................................................174
A3.8 Big ECG Signal Interference or Thick Baseline..........................................................174
A3.9 NIBP and SpO2 No Results .........................................................................................175
A3.10 Blown Fuses...............................................................................................................175
B FTS-3 Fetal Telemetry System .............................................................................................177
B3.1 Troubleshooting............................................................................................................177
B3.2 Blown Fuses .................................................................................................................177
Appendix 4 Ultrasound Intensity and Safety ..........................................................................180
A4.1 Ultrasound in Medicine ...................................................................................................180
A4.2 Ultrasound Safety and the ALARA Principle..................................................................180
A4.3 Explanation of MI/TI.......................................................................................................180
A4.3.1 MI (Mechanical Index) .............................................................................................180
A4.3.2 TI (Thermal Index)....................................................................................................181
A4.3.3 Measurement Uncertainty.........................................................................................181
A4.4 Prudent Use Statement.....................................................................................................182
A4.5 References for Acoustic Output and Safety.....................................................................182
A4.6 Transducer Acoustic Output Parameters List ..................................................................183

IX
A4.6.1 Test of Wired Transducer ..........................................................................................183
A4.6.2 Test of Wireless Transducer (FTS-3).........................................................................184
A4.6.3 Standard Parameter Equal Contrast List ...................................................................187
Appendix 5 Abbreviation ..........................................................................................................189
Appendix 6 Ordering Information...........................................................................................191
Appendix 7 EMC Information..................................................................................................194
A7.1 Electromagnetic Emissions..............................................................................................194
A7.2 Electromagnetic Immunity ..............................................................................................195
A7.3 Electromagnetic Immunity ..............................................................................................197
A7.4 Recommended Separation Distances...............................................................................200
Appendix 8 Limitations of Ultrasonic Monitoring..................................................................201
A8.1 How Does Ultrasound Work............................................................................................201
A8.2 Artifacts in Fetal Heart Monitoring .................................................................................201
A8.3 Audio Output and Screen Reading ..................................................................................203

F9, F9 Express Fetal & Maternal Monitor User Manual Safety Guidance
- 1 -
Chapter 1 Safety Guidance
CAUTION
Federal (U.S.) Law restricts this device to sale by or on the order of a physician.
NOTE:
1 In order to ensure the operator and patient’s safety, read through this chapter before
using this monitor.
2 This user manual is written to cover the maximum configuration. Therefore, your
model may not have some of the parameters and functions described, depending on
what you have ordered.
3 The functions frequently used are marked with an asterisk *, for example 4.10
*Reviewing Alarms.
The monitor mainly consists of the main unit, FTS-3 fetal telemetry system (including the base
station, wireless US-T transducers, wireless TOCO-T transducer or TOCO-E transducer, DECG
cable and MECG cable), built-in recorder, recorder paper, US transducer, TOCO transducer, ECG
lead, NIBP cuff, SpO2 sensor, TEMP sensor, event remote marker, fetal stimulator, IUP cable and
catheter and other accessories.
The monitor is intended to monitor FHR, DECG, fetal movement, TOCO, ECG, PR, IUP, NIBP,
SpO2, TEMP.
1.1 Intended Use/Indications for Use
F9 Fetal & Maternal Monitor (hereinafter called F9):
The F9 Fetal & Maternal Monitor is intended for non-invasive and invasive monitoring of fetus
during antepartum examination, labor and delivery. It is intended to be used only by trained and
qualified personnel in antepartum examination rooms, labor and delivery rooms.
F9 Fetal & Maternal Monitor provides Non-Stress testing for pregnant women. It can externally
monitor the FHRs using ultrasound and uterine activity via a TOCO transducer. Alternatively, it
can internally monitor one of the FHRs with DECG and uterine activity with an IUPC.
F9 Express Fetal & Maternal Monitor (hereinafter called F9 Express):
F9 Express Fetal & Maternal Monitor is intended for monitoring physiological parameters of
pregnant women during antepartum examination, labor and delivery. It is intended to be used
only by trained and qualified personnel in antepartum examination rooms, labor and delivery
rooms.
F9 Express Fetal & Maternal Monitor is intended for providing Non-Stress testing or fetal
monitoring for pregnant women. In addition, it provides a solution for maternal vital signs

F9, F9 Express Fetal & Maternal Monitor User Manual Safety Guidance
- 2 -
monitoring.
Contraindications:
They are not intended for use in intensive care units, operating rooms or for home use.
1.2 Features
The following table lists the measurements that F9 and F9 Express support.
Model
Measurement
F9
F9 Express
FHR
√
√
TOCO
√
√
FM
√
√
AFM
√
√
DECG
Opt
Opt
IUP
Opt
Opt
MECG
×
√
NIBP
×
√
MSpO2
×
√
TEMP
×
√
NOTE: √ = Standard Opt = Optional × = Not Available
For the Essential Performance of F9 and F9 Express, refer to Appendix 1 in details.
1.3 Instruction for Safe Operation
NOTE:
In this manual, Monitor refers to both F9 and F9 Express, and is used where the
information applies to both models.
The monitor is designed to comply with the international safety requirements IEC/EN
60601-1 for medical electrical equipment. It is class I equipment.
The monitor operates within specifications at ambient temperatures between +5 ºC (+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.

F9, F9 Express Fetal & Maternal Monitor User Manual Safety Guidance
- 3 -
The monitor must be serviced only by authorized and qualified personnel. The manufacturer
does not accept responsibility for safety compliance, reliability and performance if
modifications or repairs are carried out by unauthorized personnel. Identical replacement
parts must be used.
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)
External TOCO
Fetal Movement Mark (FM)
Fetal Stimulator (FS)
Intrauterine Pressure (IUP)
Type BF
Non-invasive Blood Pressure (NIBP)
Arterial Oxygen Saturation (SpO2)
Type BF, defibrillation-proof
Direct Electrocardiography (DECG)
Type CF
Electrocardiography (ECG)
Temperature (TEMP)
Type CF, defibrillation-proof
The monitor described in this user manual is not protected against:
a) The effects of high frequency currents
b) The interference of electrosurgery equipment
1.4 Ultrasound Safety Guide
Fetal Use
The monitor is designed for continuous fetal heart rate monitoring during pregnancy and labor.
Clinical interpretation of fetal heart rate traces can diagnose fetal and/or maternal problems and
complications.
Instructions for Use in Minimizing Patient Exposure
The acoustic output of the monitor is internally controlled and can not be varied by the operator
in the course of the examination. The duration of exposure is, however, fully under the control of
the operator. Mastery of the examination techniques described in the User Manual will facilitate
obtaining the maximum amount of diagnostic information with the minimum amount of exposure.
The exercising of clinical judgment in the monitoring of low risk patients will avoid unnecessary
insonation.

F9, F9 Express Fetal & Maternal Monitor User Manual Safety Guidance
- 4 -
1.5 Safety Precautions
WARNING and CAUTION messages must be observed. To avoid the possibility of injury,
observe the following precautions during the operation of the instrument.
WARNING
For using safety:
1 The monitor or FTS-3 telemetry system (hereinafter called FTS-3) is provided for the
use of qualified physicians or personnel professionally trained.
2 The monitor is not intended for use in intensive care units (ICU), operating rooms or
for home use.
3 Do not switch on the monitor until all cables have been properly connected and
verified.
4 EXPLOSION HAZARD - Do not use the monitor or FTS-3 system in the presence of
flammable anesthetics or other materials.
5 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.
6 Multiple portable socket-outlets shall not be placed on the floor.
7 Additional multiple socket-outlet or extension cord can’t be connected to the system.
8 The multiple portable socket-outlet provided with the system shall be only used for
supplying power to equipment which is intended to form part of the system. If the
electrical device that does not belong to the system plug in the socket, the total
power may exceed the maximum load of the separating transformer and cause high
temperature and fire. Enclosure leakage current within the system exceeds the
standard limit, which may lead an electric risk.
9 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.
10 Do not touch accessible parts of non-medical electrical equipment and the patient
simultaneously. Do not touch the signal input or output connector and the patient
simultaneously.
11 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.

F9, F9 Express Fetal & Maternal Monitor User Manual Safety Guidance
- 5 -
WARNING
12 Connecting any accessory (such as external printer) or other device (such as the
computer) to this monitor makes a medical system. In that case, additional safety
measures should be taken during installation of the system, and the system shall
provide:
a) Within the patient environment, a level of safety comparable to that provided by
medical electrical equipment complying with IEC/EN 60601-1, and
b) Outside the patient environment, the level of safety appropriate for non-medical
electrical equipment complying with other IEC or ISO safety standards.
13 Using accessories other than those specified by the manufacturer may result in
increased electromagnetic emissions or decreased electromagnetic immunity of the
device.
14 The device should not be used adjacent to or stacked with other equipment and that
if adjacent or stacked use is necessary, the device should be observed to verify
normal operation in the configuration in which it will be used.
15 All the accessories connected to system must be installed outside the patient vicinity,
if they do not meet the requirement of IEC/EN 60601-1.
16 Do not exceed the maximum permitted load when using multiple portable
socket-outlets to supply the system.
17 SHOCK HAZARD –Do not 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. 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.
18 SHOCK HAZARD - Don't connect electrical equipment, which has not been supplied
as a part of the system, to the multiple portable socket-outlet supplying the system.
19 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.
20 Do not apply this monitor and other ultrasonic equipment simultaneously on a same
patient, in case of possible hazard caused by leakage current superposition. Do not
apply this monitor simultaneously with other PATIENT-connected equipment, such as,
a cardiac pacemaker or other electrical stimulators, on the same patient.
21 The monitor can only be used on one patient at a time.
22 SHOCK HAZARD - Do not remove the top panel cover during operation or while
power is connected.
23 Equipment and devices that connect to the monitor should form an equipotential
body to ensure effective grounding.

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WARNING
24 Only connect accessories supplied or recommended by the manufacturer to the
device.
25 The system should be operated by the doctor or under the doctor’s instructions.
26 Do not apply the monitor during electro-surgery or MRI; otherwise it might result in
harming the patient or the operator.
27 ECG cables may be damaged when connected to a patient during defibrillation.
Check cables for functionality before using them again.
28 Only MECG, SpO2, NIBP and TEMP applied parts of the monitor are
defibrillation-proof. When a defibrillator is applied, keep other accessories away from
the patient. Otherwise it may result in damaging the monitor or harming the patient.
29 After defibrillation, the screen display recovers within 10 seconds if the correct
electrodes are used and applied based on the manufacturers’ instructions.
30 Any non-medical equipment (such as the external printer) is not allowed to be used
within the patient vicinity (1.5m/6ft.).
31 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.
32 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.
33 Do not service or maintain the monitor or any accessory which is in use with the
patient.
34 Assembly of the monitor and modifications during actual service life shall be
evaluated based on the requirements of IEC60601-1.
For proper monitoring:
35 Alarms must be set up according to different situations of patients. Make sure that
audio sounds can be activated when an alarm occurs.
36 Do not perform NIBP measurements on patients with sickle-cell disease or under
any condition where the skin is damaged or expected to be damaged.
37 Clinical decision making based on the output of the device is left to the discretion of
the provider.
38 Do not put the sensor on extremities with arterial catheter or venous syringe.
39 Do not apply the cuff to a limb that has an intravenous infusion or catheter in place.
This could cause tissue damage around the catheter when infusion is slowed or
blocked during cuff inflation.
40 The disposable accessories are intended to be used only once. Dispose of them
properly after use and do not reuse them.
41 The spiral electrode and IUP catheter are disposable and should not be reused.

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WARNING
42 The IUPC is neither intended nor approved for measuring intrauterine pressure
extraovularly; attempting to do so may lead to maternal discomfort or injury.
For using the Battery:
43 Before using the rechargeable lithium-ion battery (hereinafter called battery), be sure
to read the user manual and safety precautions thoroughly.
44 Use the battery only in the F9 or F9 Express monitor.
45 Do not reverse the battery pole or it will cause explosion.
46 Do not unplug the battery when monitoring.
47 Do not heat or throw the battery into a fire.
48 Before using the battery, make sure to read the user manual and safety precautions
thoroughly.
49 Do not use or leave battery close to fire or other places where temperatures may be
above +60 ºC (+140 ºF).
50 Do not immerse, throw or wet the battery in water/ seawater.
51 Do not destroy the battery: Do not pierce battery with a sharp object such as a
needle. Do not hit with a hammer, step on or throw or drop to cause strong shock.
Do not disassemble or modify the battery.
52 Do not short-circuit the battery by connecting the battery cable connector or battery
socket with metal objects or solder.
53 If the liquid leak from the battery spills onto your skin or clothes, wash well with fresh
water immediately.
54 If the liquid leak from the battery gets into eyes, do not rub the eyes. Wash them well
with clean water and see a doctor immediately.
55 Keep the battery away from fire immediately when leakage or foul odor is detected.
56 Stop using the battery if abnormal heat, odor, discoloration, deformation or abnormal
condition is detected during use, charge, or storage. Keep it away from the monitor.
57 Remove the battery and store it at a cool and dry environment if the monitor is not
used for a long time.
58 Unplug the monitor before installing and removing the battery.
59 Do not connect the battery directly to an electric outlet or cigarette lighter charger.
60 Batteries have life cycles. If the time that the monitor using battery becomes much
shorter than usual, the battery life is at an end. Replace the battery with a new one
of the same specification as the one provided or recommended by the manufacturer.
61 If the battery is stored alone and not used for a long time, we recommend that the
battery should be charged at least once every 6 months to prevent overdischarge.
62 Only rechargeable button cell supplied or recommended by EDAN can be used.

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WARNING
For network safety:
63 Given the vulnerabilities of WEP, it is advised to use WAP and WAP2. WEP should
not be used as it is not secure.
64 Data in transit is no encrypted. Local Area Network isolation or other protections are
suggested to prevent unintended exposure of PHI.
In addition, when you use the FTS-3 fetal telemetry system, please pay attention to the
warnings as follows:
65 The system should be operated by the doctor or under the doctor’s instructions.
66 SHOCK HAZARD –The base station and transducers for one patient must be
supplied by the same power and do not change the power supply.
67 Please arrange a function test periodically for the system.
68 Do not move the system when it is powered on and do not soak it in any liquid.
69 Please check the transducer, cable and base station periodically. If the transducers
are damaged, do not use them in water and repair them in time.
70 The battery in the wireless transducer should be replaced by the serviceman
authorized by EDAN.
71 If the transducer has been beaten or knocked, please check whether the cover is
airproof or damaged. If you have any doubt, please contact the manufacturer or local
agent.
72 If the battery in the base station is stored alone and not used for a long time, we
recommend that the battery should be charged at least once every 6 months to
prevent over discharge.
73 The wireless transducer has priority over the wired transducer. When the wireless
transducer is working, the wired transducer will be turned off automatically. Do not
use the wireless transducer and the wired transducer at the same time.
CAUTION
1 The device is designed for continuous operation. Avoid liquid splashing on the
device.
2 Refer servicing to qualified personnel.
3 Keep the environment clean. Avoid vibration. Keep it far from corrosive medicine,
dust area, high-temperature and humid environment.
4 When installing the unit into a cabinet, allow for adequate ventilation, accessibility for
servicing, and room for adequate visualization and operation.
5 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.
6 The appliance coupler or mains plug is used as isolation means from supply mains.
Position the monitor in a location where the operator can easily access the
disconnection device.

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CAUTION
7 Do not sterilize the monitor or any accessory with autoclave or gas.
8 Switch off the system power before cleaning. Cleaning consists of removing all dust
from the exterior surface of the equipment with a soft brush or cloth.
9 Only the sensor and cable of US/TOCO transducers are watertight. Pay attention not
let any liquid enter the transducer plug.
10 Electromagnetic Interference - Ensure that the environment in which the monitor
or FTS-3 is installed is not subject to any source of strong electromagnetic
interference, such as CT, radio transmitters, mobile phone base stations, etc. Even
though other devices are in accordance with national standard radiation requirements,
the monitor or FTS-3 may be interfered.
11 Electromagnetic Interference - Do not use mobile phones nearby in the process of
monitoring
12 Operation of the equipment below the minimum amplitude may cause inaccurate
results.
13 Electromagnetic Interference - Fetal parameters, especially ultrasound and ECG,
are sensitive measurements involving small signals, and the monitoring equipment
contains very sensitive high gain front-end amplifiers. Immunity levels for radiated
RF electromagnetic fields and conducted disturbances induced by RF fields are
subject to technological limitations. To ensure that external electromagnetic fields do
not cause erroneous measurements, it is recommended to avoid the use of
electrically radiating equipment in close proximity to these measurements.
14 Electromagnetic Interference - The monitor or FTS-3 system should not be used
adjacent to or stacked with other equipment, refer to section A7.4 Recommended
Separation Distances.
15 Electromagnetic interference is not unique to this system but is characteristic of fetal
patient monitoring equipment in use today. This performance is due to very sensitive
high gain front-end amplifiers required to process the small physiological signals
from the patient. Among the various monitoring systems already in clinical use,
interference from electromagnetic sources is rarely a problem.
16 The medical electrical equipment needs to be installed and put into service
according to Appendix 7 EMC Information.
17 Portable and mobile RF communications equipment can affect medical electrical
equipment, refer to sectionA7.4 Recommended Separation Distances.
18 Sterility cannot be guaranteed if package of the fetal spiral electrode is broken or
opened.
19 The fetal spiral electrode has been sterilized by gamma radiation. Do not re-sterilize.
20 The device and reusable accessories could be sent back to the manufacturer for
recycling or proper disposal after their useful lives.