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