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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F15 Series Fetal & Maternal Monitor User Manual Safety Guidance
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-WI-FI ● ●
-Battery √ √
NOTE:
√
= Standard
●
= Optional
―
= Not Available
1.3 Instruction for Safe Operation
NOTE:
In this manual, Monitor refers to both F15 and F15 air, and is used where the information
applies to both models.
The monitor is designed to comply with the international safety requirements IEC/EN 60601-1 for
medical electrical equipment. It is class I equipment.
The monitor operates within specifications at ambient temperatures between 0ºC (+32 ºF) and
+40 ºC (+104 ºF). Ambient temperatures that exceed these limits could affect the accuracy of the
instrument and cause damage to the modules and circuits. Allow at least 2 inches (5 cm)
clearance around the instrument for proper air circulation.
You must check that the equipment, cables and transducers do not have visible evidence of
damage that may affect patient safety or monitoring capability before each use. If damage is
evident, replacement is recommended before use.
The monitor must be serviced only by authorized and qualified personnel. The manufacturer does
not accept responsibility for safety compliance, reliability and performance if modifications or
repairs are carried out by unauthorized personnel. Identical replacement parts must be used.
The typical operator's position is in front of the monitor. Please position the device in a location
where the operator can easily see the screen and access the operating controls.
The protective degree against electric shock of the patient connections is:
Ultrasound (FHR1, FHR2, FHR3)
External TOCO
Fetal Movement Mark (FM)
Intrauterine Pressure (IUP)
Maternal Electrocardiography (MECG)
Direct Electrocardiography(DECG)
Fetal Electrocardiography (FECG)
Type CF
Non-invasive Blood Pressure (NIBP)
Arterial Oxygen Saturation (SpO2)
Temperature (TEMP) Type CF, defibrillation-proof
The monitor described in this user manual is not protected against:
a) The effects of high frequency currents
b) The interference of electrosurgery equipment
1.4 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
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F15 Series Fetal & Maternal Monitor User Manual Safety Guidance
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For using safety:
1 The monitor 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 No modification of this monitor is allowed.
4 Do not switch on the monitor until all cables have been properly connected and verified.
5 EXPLOSION HAZARD - Do not use the monitor in the presence of flammable anesthetics
or other materials.
6 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.
7 The protective earth conductor is required for EMC purposes. It has no protective function
against electric shock. Double and/or reinforced insulation protects this device against
electric shock.
8 Multiple portable socket-outlets shall not be placed on the floor.
9 Additional multiple socket-outlet or extension cord can’t be connected to the system.
10 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.
11 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.
12 SHOCK HAZARD-To avoid the risk of electric shock, this equipment must only be
connected to a supply mains with protective earth.
13 Do not touch accessible parts of non-medical electrical equipment and the patient
simultaneously.
14 Do not touch the signal input or output connector and the patient simultaneously.
15 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.
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WARNING
16 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.
17 Using accessories other than those specified by the manufacturer may result in increased
electromagnetic emissions or decreased electromagnetic immunity of the device.
18 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.
19 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.
20 Do not exceed the maximum permitted load when using multiple portable socket-outlets to
supply the system.
21 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.
22 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.
23 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.
24 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.
25 Do not place the TOCO transducer on the oedematous or fragile tissue; change the
measuring sites after half an hour.
26 The monitor can only be used on one patient at a time.
27 SHOCK HAZARD - Do not remove the top panel cover during operation or while power is
connected.
28 Equipment and devices that connect to the monitor should form an equipotential body to
ensure effective grounding.
29 No modification of this equipment is allowed without authorization of the manufacturer. If
this equipment is modified, appropriate inspection and testing must be conducted to
ensure continued safe operation.
30 Only connect accessories supplied or recommended by the manufacturer to the device.
31 The system should be operated by the doctor or under the doctor’s instructions.
WARNING
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32 Do not apply the monitor during electro-surgery or MRI; otherwise it might result in
harming the patient or the operator.
33 ECG cables may be damaged when connected to a patient during defibrillation. Check
cables for functionality before using them again.
34 Only 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.
35 After defibrillation, the screen display recovers within 10 seconds if the correct electrodes
are used and applied based on the manufacturers’ instructions.
36 Any non-medical equipment (such as the external printer) is not allowed to be used within
the patient vicinity (1.5m/6ft.).
37 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.
38 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.
39 Never reuse disposable transducers, sensors, accessories, and so forth that are intended
for single use, or single patient use only. Reuse may compromise device functionality and
system performance, and cause a potential hazard.
40 Do not use a damaged transducer or one with exposed electrical contacts.
41 When connecting devices for acquiring measurements, always position cables and NIBP
tubing carefully to avoid entanglement or potential strangulation.
42 Do not service or maintain the monitor or any accessory which is in use with the patient.
43 Assembly of the monitor and modifications during actual service life shall be evaluated
based on the requirements of IEC60601-1.
44 The disposable ECG electrode cannot be reused and cannot be used in case of package
damage.
45 The instrument is precise; especially the touch screen is fragile. Therefore, for fear of
instrument damage, do not operate the instrument violently, and avoid falling and
impacting during usage.
For proper monitoring:
46 Alarms must be set up according to different situations of patients. Make sure that audio
sounds can be activated when an alarm occurs.
47 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.
48 Clinical decision making based on the output of the device is left to the discretion of the
provider.
49 Do not put the sensor on extremities with arterial catheter or venous syringe.
50 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.
WARNING
51 The disposable accessories are intended to be used only once. Dispose of them properly
after use and do not reuse them.
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52 The spiral electrode and IUP catheter are disposable and should not be reused.
53 The IUPC is neither intended nor approved for measuring intrauterine pressure
extraovularly; attempting to do so may lead to maternal discomfort or injury.
54 FTS-3 transducers have priority over F15 series US Transducers, DECG Fetal & Maternal
Module, TOCO transducer and FECG Fetal&Maternal Module. When FTS-3 transducers get
on line, F15 series US Transducers, DECG Fetal & Maternal Module, TOCO transducer and
FECG Fetal&Maternal Module will be disabled.
For using the Battery:
55 Before using the rechargeable lithium-ion battery (hereinafter called lithium battery), be
sure to read the user manual and safety precautions thoroughly.
56 The lithium battery can only be used for this device.
57 The lithium battery can only be charged in this device.
58 Do not reverse the lithium battery polarity.
59 Do not connect the positive (+) and negative (-) terminals with metal objects such as lead
wire, which can result in short circuits.
60 The cycle life of the lithium battery is 300 times. The service life of the lithium battery may
shorten if it is used inappropriately. It is recommended to replace the lithium battery after
300 charge-discharge cycles, or it may cause safety risks such as heat and liquid leakage,
and risks such as failure or decline of performance.
61 Do not heat or throw the lithium battery into a fire.
62 Do not immerse, throw or wet the lithium battery in water, beverages or other liquids.
63 Do not use or leave lithium battery at high temperature (charging>35℃, discharging>60℃,
such as in direct sunlight or in a very hot car), otherwise it may cause overheat, fire,
malfunction to the lithium battery, shorten the service life of the lithium battery, or damage
the lithium battery.
64 Do not place the lithium battery near microwave equipment or other cooking devices. If the
lithium battery is heated or subjected to strong electromagnetic radiation, liquid leakage,
heat, smoke, fire, etc. may occur.
65 Do not hit with a hammer, step on or throw or drop to cause strong shock.
66 Do not weld the lithium battery directly.
67 Do not use a lithium battery of other specifications.
68 Do not use a lithium battery with serious scratch or deformation.
69 Keep lithium batteries out of the reach of children.
70 Power off the device, remove and stop using the lithium battery if abnormal heat, odor,
discoloration, deformation or abnormal condition is detected during use, charge, or
storage, or it may cause safety accidents such as heat, smoke, and fire.
71 Do not touch a leaking lithium battery. If the liquid leaked from the lithium battery gets into
eyes, do not rub the eyes. Wash them well with clean water and see a doctor immediately.
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WARNING
72 When the device is running on lithium battery power, do not replace the lithium battery
during operation of the device.
73 High internal temperature may also cause the lithium battery unable to be charged. Keep
the device at room temperature and move it away from heat sources or out of direct
sunlight. The lithium battery will resume charging when the temperature is within range
again.
74 Lithium batteries should be charged, used and stored in places far away from static
electricity.
75 Only rechargeable button cell supplied or recommended by EDAN can be used. The
rechargeable button should be replaced by serviceman authorized by EDAN if needed.
76 Do not replace the lithium battery in the transducer by yourself. If you need to replace the
lithium battery, please contact EDAN or qualified service professionals authorized by EDAN
for replacement. 
77 If any serious incident that has occurred in relation to the device, user and/or patient
should report to the manufacturer and the competent authority of the Member State in
which the user and/or patient is established.
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.
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 The materials with which the patient or any other person can come into contact conform to
the standard of EN ISO 10993-1.
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CAUTION
11 Electromagnetic Interference - Ensure that the environment in which the monitor is
installed is not subject to any source of strong electromagnetic interference, such as CT,
radio transmitters, mobile phone base stations, etc. Even though other devices are in
accordance with national standard radiation requirements, the monitor may be interfered.
12 Electromagnetic Interference - Do not use mobile phones nearby in the process of
monitoring.
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 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 section A7.4 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.
21 The recommended battery charging temperature ranges from 0°C (32 ºF ) to 35°C (95 ºF ).
22 If the terminals of the battery become dirty, wipe with a dry cloth before using the battery.
23 The device and accessories are to be disposed of according to local regulations after their
useful lives. Alternatively, they can be returned to the dealer or the manufacturer for
recycling or proper disposal. Batteries are hazardous waste. Do NOT dispose them
together with house-hold garbage. At the end of their life hand the batteries over to the
applicable collection points for the recycling of waste batteries. For more detailed
information about recycling of this product or battery, please contact your local Civic
Office, or the shop where you purchased the product.
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1.5 Safety Information
1.5.1 Protecting Personal Information
Protecting personal health information is a major component of security strategy. To protect the
personal information and ensure the proper device performance, the user should take necessary
precautions in accordance with local laws and regulations and institution’s policies. EDAN
recommends health care organizations or medical institutions to implement a comprehensive and
multifaceted strategy to protect the information and systems from internal and external security
threats.
To ensure the patients’ safety and protect their personal health information, the user should implement
practices or measures that include:
1. Physical safeguards - physical safety measures to ensure that unauthorized personnel do not
have access to the monitor.
2. Operational safeguards - safety measures during operation.
3. Administrative safeguards - safety measures in management.
4. Technical safeguards - safety measures in technical field.
CAUTION
1 The operation of the monitor is restricted to authorized personnel only. Assign only staff
with a specific role the right to use the monitor.
2 Ensure that all device components maintaining personal information (other than
removable media) are physically secure.
3 Ensure that the monitor is connected only to the device authorized/approved by EDAN.
Users should operate all EDAN deployed and supported monitors within EDAN authorized
specifications, including EDAN approved software, software configuration, security
configuration, etc.
4 Protect all the passwords to prevent unauthorized changes. Only the manufacturer’s
service personnel are allowed to modify the Factory Maintain settings.
5 Anti-virus measures such as USB device virus scanning should be carried out prior to
using USB flash drive.
6 Firewalls and/or other security devices should be in place between the medical system
and any externally accessible systems. It’s recommended to use Windows defender
firewall or any other firewall that can defend against DoS and DDoS attacks, and keep it up
to date on computer installed with MFM-CNS, MFM-CNS Lite.
7 DoS and DDoS protection of the router or switch must be turned on for defensing against
attacks.
8 When the monitor is returned for maintenance, disposed of, or removed from the medical
institution for other reasons, it is necessary to ensure that all patient data are removed from
the monitor (Refer to Section File Management).
9 To avoid the transmitted data being modified maliciously and (or) stolen, enable the
network encryption of the monitor. After that, the device connected to MFM-CNS,
MFM-CNS Lite and the transmitted data will be encrypted, ensuring the safety of data
transmission.
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CAUTION
10 Protect patients’ sensitive information while using the monitor in public places. For
information and data displayed on the monitor and saved in the monitor, please pay
attention to personal information protection.
11 When setting up the network environment: 1) Please enable the MAC address filtering
function when using the wireless router. Only device whose MAC address meets
requirement can use wireless network and add the MAC address of the monitor to the list
of rules. 2) Suggest to build a VLAN. Assign the switch port, LAN port used by monitor and
central station to the same VLAN, separated with other VLAN.
12 The upgrade of the monitor can only be carried out by persons authorized by the
manufacturer.
NOTE:
Log files generated by the monitor are used for system troubleshooting and do not contain
protected medical data.
1.5.2 Security
For more security operations, please enter Main Menu > System, input user maintain password >
Security configuration. In this window:
Set the on or off of Password Activation. If Password Activation is set to On, after the device is
restarted, the user shall modify the user maintenance password to enter the operation interface
on password input interface; If Password Activation is set to Off, the user can enter the operation
interface without modifying the password.
Note:
Please modify the user maintenance password according the prompt. The default initial user
maintenance password is 9999.
Choose the Login Timing time. If the user has not operated the monitor within the chosen time,
the user shall input the user maintenance password in the pop-up window when operating the
monitor again. If the user chooses Infinite, he will not be required to input the user maintenance
password.
Click Password Revision to enter the interface of modifying user maintenance password, please
modify the password according to the prompt. For security's sake, please modify the password
regularly. It is recommended that the password is composed of letters and numbers.
Click Restore Password to restore the user maintenance password to initial user maintenance
password.
Note:
Only the personnel of manufacturer can restore the user maintenance password. If the user
forgets the original user maintenance password, please contact the personnel of manufacturer
to restore the password.
Choose the time of Dynamic Password Period. The system updates the Maintenance Password
Credential of manufacturer according to the chosen time.
Note:
If the device needs manufacturer’s maintenance, the user shall inform the personnel of
manufacturer of the password credential in the password input interface according to which
the personnel of manufacturer can acquire the maintenance authority of manufacturer.
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Set the on or off of Authority Control. When the Authority Control is set to On, it can resist
against virus attack.
Set the on or off of Firewall. When the Firewall is set to On, it can resist against network attack.
Set the on or off of Network Encryption. When the Network Encryption is set to On, it can
identify the accessed MFM-CNS, MFM-CNS Lite and encrypt the data transmitted from
MFM-CNS, MFM-CNS Lite so as to ensure the security of data transmission.
Set the on or off of Saving Encryption. When the Saving Encryption is set to On, it can encrypt
the data exported to USB drive so as to ensure the security of exported data.
1.6 Definitions and Symbols
F15 Series Fetal & Maternal Monitor
1
Fetal monitoring socket, ultrasound transducers, TOCO transducer
and DECG Fetal&Maternal Module can be connected to it( Type CF
applied part)
2
Socket for Remote Event Marker ( Type CF applied part)
3
Socket for Fetal Stimulator ( Type CF applied part)
4
Socket for ECG cable ( Type CF applied part)
5
TEMP
Socket for TEMP Transducer ( Type CF applied part)
6
NIBP
Socket for NIBP Cuff ( Type CF applied part)
7
SpO2 (EDAN)
Socket for SpO2Transducer ( Type CF applied part)
8
SPO2(Nellcor)
Socket for SpO2Transducer ( Type CF applied part)
9
DB9 interface
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