EDAN F15 Series User manual

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About this Manual
P/N: 01.54.458308
Version: 1.4
MPN: 01.54.458308014
Release Date: Aug. 2020
© Copyright EDAN INSTRUMENTS, INC. 2019-2020.All rights reserved.
Statement
This manual will help you understand the operation and maintenance of the product better. It is
reminded that the product shall be used strictly complying with this manual. User’s operation failing to
comply with this manual may result in malfunction or accident for which EDAN INSTRUMENTS, INC.
(hereinafter called EDAN) can not be held liable.
EDAN owns the copyrights of this manual. Without prior written consent of EDAN, any materials
contained in this manual shall not be photocopied, reproduced or translated into other languages.
Materials protected by the copyright law, including but not limited to confidential information such as
technical information and patent information are contained in this manual, the user shall not disclose
such information to any irrelevant third party.
The user shall understand that nothing in this manual grants him, expressly or implicitly, any right or
license to use any of the intellectual properties of EDAN.
EDAN holds the rights to modify, update, and ultimately explain this manual.
Responsibility of the Manufacturer
EDAN only considers itself responsible for any effect on safety, reliability and performance of the
equipment if:
Assembly operations, extensions, re-adjustments, modifications or repairs are carried out by persons
authorized by EDAN, and
The electrical installation of the relevant room complies with national standards, and
The instrument is used in accordance with the instructions for use.
Terms Used in this Manual
This guide is designed to give key concepts on safety precautions.
WARNING
A WARNING label advises against certain actions or situations that could result in personal injury or
death.
CAUTION
A CAUTION label advises against actions or situations that could damage equipment, produce
inaccurate data, or invalidate a procedure.
NOTE
A NOTE provides useful information regarding a function or a procedure.
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Table of Content
Chapter1 Safety Guidance......................................................................................... 1
1.1 Intended Use/Indications for Use.......................................................................................... 1
1.2 Features................................................................................................................................ 1
1.3 Instruction for Safe Operation............................................................................................... 3
1.4 Safety Precautions................................................................................................................ 3
1.5 Safety Information................................................................................................................. 2
1.5.1 Protecting Personal Information................................................................................. 2
1.5.2 Security....................................................................................................................... 3
1.6 Definitions and Symbols ....................................................................................................... 4
Chapter2 Installation.................................................................................................. 8
2.1 Opening the Package and Checking.................................................................................... 8
2.2 Installing Battery.................................................................................................................... 8
2.2.1 Patient Transfer Within the Hospital........................................................................... 9
2.3 Installing Monitor................................................................................................................... 9
2.4 Loading Recorder paper....................................................................................................... 9
2.5 Connecting Power Cable.....................................................................................................11
2.6 Installing Transducer Holder Bracket.................................................................................. 12
Chapter3 Basic Operation ....................................................................................... 14
3.1 Overview ............................................................................................................................. 14
3.1.1 Left Panel.................................................................................................................. 14
3.1.2 Right Panel ............................................................................................................... 15
3.1.3 Rear Panel................................................................................................................ 16
3.1.4 Bottom Panel ............................................................................................................ 16
3.1.5 Indicators .................................................................................................................. 17
3.2 Transducers and Cables..................................................................................................... 17
3.2.1 Transducers.............................................................................................................. 18
3.2.2 Remote Event Marker(Optional for F15 Only).......................................................... 21
3.2.3 DECG Cable............................................................................................................. 22
3.2.4 DECG-IUP Integrated Cable .................................................................................... 22
3.2.5 Fetal Spiral Electrode................................................................................................ 22
3.2.6 IUP Catheter............................................................................................................. 23
3.2.7 ECG Cable................................................................................................................ 23
3.2.8 SpO2Sensor............................................................................................................. 23
3.2.9 NIBP Cuff.................................................................................................................. 24
3.2.10 TEMP Sensor.......................................................................................................... 24
3.3 FT20 Telemetry Transmitter................................................................................................ 24
3.3.1 Charging FT20 Telemetry Transmitter...................................................................... 25
3.3.2 Displaying of FT20 Telemetry Transmitter................................................................ 25
3.3.3 Power Key................................................................................................................. 25
3.4 Wireless Transducer........................................................................................................... 25
3.4.1 Charging Wireless Transducer................................................................................. 25
3.4.2 Displaying of Wireless Transducer........................................................................... 26
3.4.3 Close Wireless Transducer....................................................................................... 27
3.4.4 Monitor the Ambulatory Patient ................................................................................ 28
3.5 Operating and Navigating................................................................................................... 28
3.5.1 Screen Elements ...................................................................................................... 28
3.5.2 Main Menu................................................................................................................ 33
3.5.3 Quick Setup .............................................................................................................. 33
3.6 Monitoring Interface............................................................................................................ 34
3.6.1 Interface Display....................................................................................................... 34
3.6.1.1 *Switch Display Mode..................................................................................... 34
3.6.1.2 *Background Color Switch.............................................................................. 35
3.6.1.3 Changing Numeric Window Position (Suitable forAP/IP Configuration Models)
.................................................................................................................................... 35
3.6.1.4 Changing Time Scale..................................................................................... 35
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3.6.2 Monitoring Numerics................................................................................................. 36
3.6.2.1 Fetal Monitoring.............................................................................................. 36
3.6.2.2 Maternal Monitoring(F15)............................................................................... 40
3.6.3 Trace Control Tools................................................................................................... 42
3.6.3.1 Data Saving.................................................................................................... 43
3.6.3.2 *Searching for a File....................................................................................... 43
3.6.3.3 * File Management (Optional)........................................................................ 44
3.6.3.4 *Reviewing...................................................................................................... 46
3.6.3.5 *CTG Analysis ................................................................................................ 46
3.6.3.6 *Marking a Note.............................................................................................. 48
3.7 Introduction of FTS-3 Fetal Telemetry System ................................................................... 49
Chapter4 Alarms....................................................................................................... 50
4.1 Alarm Classification............................................................................................................. 50
4.2 Alarm Delay......................................................................................................................... 50
4.3 Audible Alarm ...................................................................................................................... 50
4.4 Visual Alarm ........................................................................................................................ 51
4.5 Choosing theAlarm Display Form...................................................................................... 52
4.6 Changing the Alarm Volume ............................................................................................... 52
4.7 *Choosing Alarm Silence Duration...................................................................................... 52
4.8 Choosing Signal Loss Delay............................................................................................... 52
4.9 Pausing or Resetting theAlarm .......................................................................................... 52
4.10 To Switch Individual MeasurementAlarms On or Off....................................................... 53
4.11 Changing the Alarm Limits................................................................................................ 53
4.12 Switching Transducer Unplugged On or Off..................................................................... 53
4.13 Switching CTGAlarm On or Off........................................................................................ 54
4.14 *Reviewing Alarms............................................................................................................ 54
4.15 Alarm Treatment Measures............................................................................................... 55
4.16 Testing Alarms................................................................................................................... 55
4.17 Patient Alarm Defaults ...................................................................................................... 55
4.18 Alarm Messages................................................................................................................ 57
4.18.1 Fetal Monitoring Alarm Messages.......................................................................... 57
4.18.2 Maternal Monitoring Alarm Messages.................................................................... 62
4.18.3 FTS-3 Technical Alarm Messages.......................................................................... 66
4.18.4 Alarm Bilateral Control............................................................................................ 67
Chapter5 Printing ..................................................................................................... 68
5.1 *Function Description.......................................................................................................... 68
5.2 Printing Configuration ......................................................................................................... 69
5.2.1 SwitchingAuto Start Printing On or Off .................................................................... 69
5.2.2 *Choosing the Paper Speed..................................................................................... 69
5.2.3 *Changing the Print Timer ........................................................................................ 69
5.2.4 Switching Print Self-Check On or Off ....................................................................... 69
5.2.5 Changing Printing End Volume................................................................................. 69
5.2.6 Changing Title Print Cycle........................................................................................ 70
5.2.7 Switching Separation Printing On or Off................................................................... 70
5.2.8 Switching Maternal Monitor Information On or Off................................................... 70
5.3 Understanding Recorder Paper Printout............................................................................. 70
Chapter6 Pre-Monitoring Preparation..................................................................... 73
6.1 Switching On the Monitor.................................................................................................... 73
6.2 Checking the Recorder Paper ............................................................................................ 73
6.3Adjusting the Screen Angle................................................................................................. 74
6.4 Setting Screen Brightness .................................................................................................. 75
6.5 Setting Date and Time ........................................................................................................ 75
6.6 Connecting Transducers..................................................................................................... 76
6.7 PlacingAccessories in the Holder...................................................................................... 76
6.8Adjusting the Volume .......................................................................................................... 76
Chapter7 Fetal Monitoring....................................................................................... 78
7.1 Confirming Fetal Life........................................................................................................... 78
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7.2 FHR Monitoring FHR with Ultrasound ................................................................................ 78
7.2.1 Monitoring FHR with Ultrasound Transducer ........................................................... 79
7.2.2 Changing the FHR Alarm Delay ............................................................................... 81
7.2.3 Testing US Transducers............................................................................................ 81
7.3 Monitoring FHR with DECG................................................................................................ 82
7.3.1 Preparing the Patient's Skin Prior to Placing Electrodes ......................................... 82
7.3.2 Directions for Using Fetal Spiral Electrode............................................................... 82
7.3.3 DECG Monitoring...................................................................................................... 83
7.3.4 Changing DECG Beep Volume ................................................................................ 84
7.3.5 DECG Gain and Display........................................................................................... 85
7.3.6 Switching theArtifact Suppression On or Off........................................................... 85
7.3.7 Detaching the Fetal Spiral Electrode........................................................................ 85
7.4 Monitoring Twin FHRs......................................................................................................... 85
7.4.1 Monitoring Twins Externally...................................................................................... 85
7.4.2 Monitoring Internally ................................................................................................. 86
7.4.3 Signals Overlap Verification (SOV) .......................................................................... 86
7.4.4 Changing FHR2 Offset ............................................................................................. 86
7.5 Monitoring Triple FHRs....................................................................................................... 87
7.5.1 Monitoring Triplets Externally ................................................................................... 87
7.5.2 Monitoring Internally ................................................................................................. 87
7.5.3 Signals Overlap Verification (SOV) .......................................................................... 87
7.5.4 Changing FHR3 Offset ............................................................................................. 87
7.6 Monitoring Uterine Activity Externally ................................................................................. 88
7.6.1 TOCO Monitoring...................................................................................................... 88
7.6.2 Changing the UABaseline........................................................................................ 89
7.6.3 Testing TOCO Transducers...................................................................................... 89
7.7 Monitoring Uterine Activity Internally................................................................................... 90
7.7.1 Parts Required.......................................................................................................... 90
7.7.2 Directions for Use of IUPC ....................................................................................... 90
7.7.3 IUP Monitoring Procedure........................................................................................ 92
7.8 Monitoring Fetal Movement ................................................................................................ 92
7.8.1 Auto Fetal Movement (AFM) Monitoring................................................................... 92
7.8.2 Enabling or Disabling AFM Monitoring..................................................................... 93
7.8.3 Choosing AFM Mode................................................................................................ 93
7.8.4 Choosing FM Source................................................................................................ 93
7.8.5 Manual Fetal Movement (MFM) Monitoring ............................................................. 93
7.8.6 Changing MFM Volume............................................................................................ 93
7.9 *Start Monitoring.................................................................................................................. 94
7.10 *Inputting Maternal Information (Mat. Info)....................................................................... 94
7.10.1 Auto ID.................................................................................................................... 94
7.10.2 Changing Maternal Information.............................................................................. 94
7.10.3 ID Entry with a Scanner.......................................................................................... 95
7.10.4 Switching Mat. Info Inputting On or Off .................................................................. 95
Chapter8 Maternal Monitoring................................................................................. 96
8.1 Maternal ECG Monitoring ................................................................................................... 96
8.1.1 Introduction............................................................................................................... 96
8.1.2 How to Place 3-lead ECG Cables............................................................................ 97
8.1.3 ECG Monitoring ........................................................................................................ 98
8.1.4 Changing ECG Gain................................................................................................. 99
8.2 Maternal SpO2Monitoring................................................................................................... 99
8.2.1 Introduction............................................................................................................... 99
8.2.2 Monitoring Procedure ............................................................................................. 101
8.2.3 Enabling SpO2Trace Printing................................................................................. 101
8.2.4Assessing the Validity of a SpO2Reading.............................................................. 101
8.2.5 SI (Signal Intensity)*............................................................................................... 102
8.2.6 SpO2Relevant Data for Reference......................................................................... 102
8.3 Maternal HR Monitoring.................................................................................................... 103
8.3.1 Introduction............................................................................................................. 103
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8.3.2 Choosing HR Source.............................................................................................. 103
8.3.3 Monitor HR with Electrode Sleeve.......................................................................... 104
8.3.4 Changing HR Beep Volume.................................................................................... 105
8.3.5 Enabling HR Trace.................................................................................................. 106
8.3.6 Signals Overlap Verification.................................................................................... 106
8.4 Maternal NIBP Monitoring................................................................................................. 106
8.4.1 Introduction............................................................................................................. 106
8.4.2 How to Apply NIBP Cuff.......................................................................................... 108
8.4.3 Measurement Procedures...................................................................................... 109
8.4.4 *Auto Measurement................................................................................................ 109
8.4.5 *Manual Measurement ............................................................................................110
8.4.6 Changing NIBP Unit.................................................................................................110
8.4.7 *Choosing NIBP Printing Mode ...............................................................................111
8.4.8 *Calibrating NIBP.....................................................................................................111
8.5 Maternal TEMP Monitoring................................................................................................111
8.5.1 Monitoring Procedure ..............................................................................................111
8.5.2 Changing TEMP Unit...............................................................................................112
Chapter9 Monitoring Mother and Fetus Using FECG.......................................... 113
9.1 Confirming Fetal Life..........................................................................................................113
9.2 Start Monitoring..................................................................................................................113
9.2.1 Introduction..............................................................................................................113
9.2.2 Parts Required.........................................................................................................114
9.2.3 Skin Preparation......................................................................................................114
9.2.4 Electrode Placement................................................................................................115
9.2.5 Connecting the ECG Leads to the Electrodes ........................................................116
9.2.6 Placing the Transducer............................................................................................116
9.2.7 Electrode Checking..................................................................................................117
9.2.8 Changing FECG Gain..............................................................................................117
9.2.9 Changing ECG Gain................................................................................................118
9.2.10 Changing FECG Beep Volume..............................................................................118
9.2.11 Monitoring Interface...............................................................................................118
Chapter10 After Monitoring................................................................................... 120
10.1 Completing Monitoring.................................................................................................... 120
10.2 Switching Off................................................................................................................... 120
Chapter11 Maintenance and Cleaning.................................................................. 121
11.1 Maintenance.................................................................................................................... 121
11.1.1 Maintaining Inspection.......................................................................................... 121
11.1.2 Maintenance of Monitor........................................................................................ 121
11.1.3 Maintenance of Wired and Wireless Transducers................................................ 121
11.1.4 Storage of Recorder Paper................................................................................... 122
11.1.5 Cleaning of Recorder............................................................................................ 122
11.1.6 Maintaining the Battery......................................................................................... 122
11.1.6.1 Checking Battery Performance.................................................................. 123
11.1.6.2 Storing the Battery...................................................................................... 123
11.2 Cleaning .......................................................................................................................... 123
11.2.1 Cleaning the Monitor............................................................................................. 124
11.2.2 Cleaning the Reusable Accessories..................................................................... 125
11.2.2.1 Cleaning the Ultrasound Transducer ......................................................... 125
11.2.2.2 Cleaning the NIBP Cuff.............................................................................. 125
11.2.2.3 Cleaning the ECG Cable Assembly........................................................... 126
11.2.2.4 Cleaning the TOCO Transducer and SpO2 Sensor................................... 126
11.2.2.5 Cleaning the TEMP Sensor........................................................................ 126
11.3 Disinfecting...................................................................................................................... 126
11.3.1 Disinfecting the Monitor........................................................................................ 127
11.3.2 Disinfecting of Reusable Accessories .................................................................. 127
11.3.2.1 Disinfecting the Ultrasound Transducer..................................................... 127
11.3.2.2 Disinfecting the NIBP Cuff.......................................................................... 128
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11.3.2.3 Disinfecting the ECG Cable Assembly....................................................... 128
11.3.2.4 Disinfecting the TOCO Transducer and SpO2 Sensor .............................. 128
11.3.2.5 Disinfecting the TEMP Sensor ................................................................... 128
11.3.3 Cleaning and Disinfecting OtherAccessories...................................................... 128
11.4 Storage............................................................................................................................ 128
Chapter12 Warranty and Service .......................................................................... 130
12.1 Contact information......................................................................................................... 130
Appendix 1 Product Specifications ...................................................................... 131
A F15 Fetal/Maternal Monitor.................................................................................................. 131
A1.1 Environmental Specifications.................................................................................. 131
A1.2 Physical Specifications............................................................................................ 131
A1.3 Performance Specifications..................................................................................... 133
A1.4 Recorder Specifications .......................................................................................... 138
A1.5 Rechargeable Lithium-ion Battery........................................................................... 139
A1.6 WIFI Specifications.................................................................................................. 140
A1.7 NFC Specifications.................................................................................................. 140
A1.8 Interface Specifications................................................................................................... 141
A1.8.1 USB Interfaces..................................................................................................... 141
A1.8.2 Wired Network Interface....................................................................................... 141
A1.8.3 HDMI Interface..................................................................................................... 141
A1.8.5 DB15 Interface ..................................................................................................... 141
Appendix 2 Signal Input/ Output Connector........................................................ 142
Appendix 3 Troubleshooting................................................................................. 143
A3.1 No Display............................................................................................................... 143
A3.2 No Touch Response................................................................................................ 143
A3.3 Noise ....................................................................................................................... 143
A3.4 Recorder Error......................................................................................................... 143
A3.5 Trouble with Ultrasound FHR Monitoring................................................................ 144
A3.6 Troubles with DECG Monitoring.............................................................................. 144
A3.7 Troubles with Contractions Monitoring (External)................................................... 145
A3.8 Troubles with Contractions Monitoring (Internal).................................................... 145
A3.9 Trouble with ECG Monitoring.................................................................................. 145
A 3.10Troubles with HR Monitoring with Electrode Sleeve............................................. 146
A3.10 No NIBP and SpO2 Results.................................................................................. 147
A3.11 Monitor Unable to be Charged.............................................................................. 147
Appendix 4 Ultrasound Intensity and Safety ....................................................... 148
A4.1 Ultrasound in Medicine................................................................................................... 148
A4.2 Ultrasound Safety and the ALARA Principle .................................................................. 148
A4.3 Explanation of MI/TI........................................................................................................ 148
A4.3.1 MI (Mechanical Index).......................................................................................... 148
A4.3.2 TI (Thermal Index)................................................................................................ 148
A4.3.3 Measurement Uncertainty.................................................................................... 149
A4.4 Prudent Use Statement .................................................................................................. 149
A4.5 References for Acoustic Output and Safety................................................................... 149
A4.6 Transducer Acoustic Output Parameters List................................................................. 150
A4.6.1 Test of Wired Transducer(F15)............................................................................. 150
A4.6.2 Test of Wireless Transducer(F15 Air)................................................................... 152
A4.6.3 Standard Parameter Equal Contrast List ............................................................. 154
Appendix 5 Abbreviation ....................................................................................... 156
Appendix 6 Ordering Information ......................................................................... 158
Appendix 7 EMC Information ................................................................................ 161
A7.1 Electromagnetic Emissions ............................................................................................ 161
A7.2 Electromagnetic Immunity.............................................................................................. 162
A7.3 Electromagnetic Immunity.............................................................................................. 165
A7.4 Recommended Separation Distances............................................................................ 167
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Appendix 8 Limitations of Ultrasonic Monitoring................................................ 168
A8.1 How Does Ultrasound Work........................................................................................... 168
A8.2 Artifacts in Fetal Heart Monitoring .................................................................................. 168
A8.3 Audio Output and Screen Reading................................................................................. 170
Appendix 9 WI-FI Networking and Instructions................................................... 172
A9.1 General........................................................................................................................... 172
A9.2 Scope ofApplication....................................................................................................... 172
A9.3 Network Installation Process.......................................................................................... 173
A9.4 Site Survey and Network Requirements ........................................................................ 173
A9.5 Network Design and Implementation ............................................................................. 175
A9.5.1 Networking Scheme............................................................................................. 175
A9.5.2 Wireless Model Network Design.......................................................................... 180
A9.6 Continuous Transmission from Disconnection of Wireless Transducer......................... 184
A9.7 Connecting the Monitor to MFM-CNS/ MFM-CNS Lite.................................................. 185
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F15 Series Fetal & Maternal Monitor User Manual Safety Guidance
- 1 -
Chapter1 Safety Guidance
CAUTION
Federal (U.S.) Law restricts this device to sale by or on the order of a physician.
NOTE:
1In order to ensure the operator and patient’s safety, read through this chapter before using
this monitor.
2This 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.
3Whenever a monitor’s identifier appears on the title, paragraph or picture, it means that the
information applies to that monitor only. Where the information applies to all models, no
distinction is made.
4The functions frequently used are marked with an asterisk *, for example 4.14 *Reviewing
Alarms.
1.1 Intended Use/Indications for Use
F15 series are intended for real time monitoring of fetal physiological parameters, including
noninvasive monitoring of single, twin or triple fetal heart rates (FHR), fetal movements (FM).
F15 series are also intended for real time monitoring of maternal physiological parameters, including
uterine activity, maternal heart rate (MHR), maternal ECG (MECG), temperature (TEMP), oxygen
saturation (SpO2), pulse rate (PR), and noninvasive blood pressure (NIBP).
F15 series are intended for invasive monitoring of direct ECG (DECG) and intrauterine pressure (IUP).
F15 series can be compatible with FTS-3 which is a wireless system intended for monitoring
physiological parameters including fetal heart rates (FHR), fetal movements (FM), uterine activity.
F15 series are intended for monitoring in a bath (FTS-3 only) or shower (FTS-3, and F15 wireless
transducers).
F15 series can display, store, and print patient information and parameters, provide alarms of fetal and
maternal parameters, and transmit patient data and parameters to Central Monitoring System.
Monitoring FHR using ultrasound is recommended from the 24th week of gestation. FECG is only
indicated for use on women who are at >36 completed weeks, with singleton pregnancies.
F15 series are intended to be used by trained health care professionals in clinical and hospital-type
facilities, in private households and during transports in healthcare facilities.
1.2 Features
F15 series fetal and maternal monitors are divided to wired models and wireless models based on
configurations and functions and there are total two models: Wired model F15 and wireless model F15
Air.
The following table lists the configuration of F15 series.
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F15 Series Fetal & Maternal Monitor User Manual Safety Guidance
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Model
Configuration
F15
F15 Air
US Transducer
-FHR-Singleton
√
√
-FHR-Twins
√
√
-FHR-Triplets
●
●
-AFM
√
√
TOCO Transducer
-TOCO
√
√
-MFM
●
●
-MECG
●
●
-HR
●
●
DECG Fetal&Maternal Module
-DECG
●
●
-IUP
●
●
FECG Fetal&Maternal Module
-eFHR-Single
―
●
-HR
―
●
-eTOCO(FECG)
―
●
-TOCO(pressure sensor)
―
●
-MFM
―
●
F15 Main Unit
-NIBP
●
―
-SpO2
●
―
-PR
●
―
-TEMP
●
―
-MFM
●
―
FT20 Telemetry Transmitter
-NIBP
―
●
-SpO2
―
●
-PR
―
●
FTS-3 Fetal Telemetry System
-FHR-Singleton
●
●
-FHR-Twins
●
●
-TOCO
●
●
- AFM
●
●
Others
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