EDAN F15 Series - User Manual

202 pages

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Traditional 510(k) of Fetal & Maternal Monitor

014_14.1_F15_Series_User_Manual

1／202

Main Page

default chapter3
- Table of Contents3
- Features9
- Safety Precautions11
Chapter1 Safety Guidance17
- Intended Use/Indications for Use17
- Safety Information18
- Protecting Personal Information18
- Instruction for Safe Operation19
- Security19
- Definitions and Symbols20
Chapter2 Installation24
- Opening the Package and Checking24
- Installing Battery24
- Patient Transfer Within the Hospital25
- Installing Monitor25
- Loading Recorder Paper25
- Connecting Power Cable27
- Installing Transducer Holder Bracket28
Chapter3 Basic Operation30
- Overview30
- Left Panel30
- Right Panel31
- Rear Panel32
- Bottom Panel32
- Indicators33
- Transducers and Cables33
- Transducers34
- Remote Event Marker(Optional for F15 Only)37
- DECG Cable38
- DECG-IUP Integrated Cable38
- Fetal Spiral Electrode38
- IUP Catheter39
- ECG Cable39
- Spo Sensor39
- NIBP Cuff40
- TEMP Sensor40
- FT20 Telemetry Transmitter40
- Charging FT20 Telemetry Transmitter41
- Displaying of FT20 Telemetry Transmitter41
- Power Key41
- Wireless Transducer41
- Charging Wireless Transducer41
- Displaying of Wireless Transducer42
- Close Wireless Transducer43
- Monitor the Ambulatory Patient44
- Operating and Navigating44
- Screen Elements44
- Main Menu49
- Quick Setup49
- Monitoring Interface50
- Interface Display50
- Switch Display Mode50
- Background Color Switch51
- Changing Numeric Window Position (Suitable for AP/IP Configuration Models)51
- Changing Time Scale51
- Monitoring Numerics52
- Fetal Monitoring52
- Maternal Monitoring(F15)56
- Trace Control Tools58
- Data Saving59
- Searching for a File59
- File Management (Optional)60
- Reviewing62
- CTG Analysis62
- Marking a Note64
- Introduction of FTS-3 Fetal Telemetry System65
Chapter4 Alarms66
- Alarm Classification66
- Alarm Delay66
- Audible Alarm66
- Visual Alarm67
- Choosing the Alarm Display Form68
- Changing the Alarm Volume68
- Choosing Alarm Silence Duration68
- Choosing Signal Loss Delay68
- Pausing or Resetting the Alarm68
- To Switch Individual Measurement Alarms on or off69
- Changing the Alarm Limits69
- Switching Transducer Unplugged on or off69
- Switching CTG Alarm on or off70
- Reviewing Alarms70
- Alarm Treatment Measures71
- Testing Alarms71
- Patient Alarm Defaults71
- Alarm Messages73
- Fetal Monitoring Alarm Messages73
- Maternal Monitoring Alarm Messages78
- Technical Alarm Messages82
- Alarm Bilateral Control83
Chapter5 Printing84
- Function Description84
- Printing Configuration85
- Switching Auto Start Printing on or off85
- Choosing the Paper Speed85
- Changing the Print Timer85
- Switching Print Self-Check on or off85
- Changing Printing End Volume85
- Changing Title Print Cycle86
- Switching Separation Printing on or off86
- Switching Maternal Monitor Information on or off86
- Understanding Recorder Paper Printout86
Chapter6 Pre-Monitoring Preparation89
- Switching on the Monitor89
- Checking the Recorder Paper89
- Adjusting the Screen Angle90
- Setting Screen Brightness91
- Setting Date and Time91
- Connecting Transducers92
- Placing Accessories in the Holder92
- Adjusting the Volume92
Chapter7 Fetal Monitoring94
- Confirming Fetal Life94
- FHR Monitoring FHR with Ultrasound94
- Monitoring FHR with Ultrasound Transducer95
- Changing the FHR Alarm Delay97
- Testing US Transducers97
- Monitoring FHR with DECG98
- Preparing the Patient's Skin Prior to Placing Electrodes98
- Directions for Using Fetal Spiral Electrode98
- DECG Monitoring99
- Changing DECG Beep Volume100
- DECG Gain and Display101
- Switching the Artifact Suppression on or off101
- Detaching the Fetal Spiral Electrode101
- Monitoring Twin Fhrs101
- Monitoring Twins Externally101
- Monitoring Internally102
- Signals Overlap Verification (SOV)102
- Changing FHR2 Offset102
- Monitoring Triple Fhrs103
- Monitoring Triplets Externally103
- Monitoring Internally103
- Signals Overlap Verification (SOV)103
- Changing FHR3 Offset103
- Monitoring Uterine Activity Externally104
- TOCO Monitoring104
- Changing the UA Baseline105
- Testing TOCO Transducers105
- Monitoring Uterine Activity Internally106
- Parts Required106
- Directions for Use of IUPC106
- IUP Monitoring Procedure108
- Monitoring Fetal Movement108
- Auto Fetal Movement (AFM) Monitoring108
- Enabling or Disabling AFM Monitoring109
- Choosing AFM Mode109
- Choosing FM Source109
- Manual Fetal Movement (MFM) Monitoring109
- Changing MFM Volume109
- Start Monitoring110
- Inputting Maternal Information (Mat. Info)110
- Auto ID110
- Changing Maternal Information110
- ID Entry with a Scanner111
- Switching Mat. Info Inputting on or off111
Chapter8 Maternal Monitoring112
- Maternal ECG Monitoring112
- Introduction112
- How to Place 3-Lead ECG Cables113
- ECG Monitoring114
- Changing ECG Gain115
- Maternal Spo Monitoring115
- Monitoring Procedure117
- Enabling Spo Trace Printing117
- Assessing the Validity of a Spo Reading117
- Signal Intensity)118
- Spo 2 Relevant Data for Reference118
- Maternal HR Monitoring119
- Introduction119
- Choosing HR Source119
- Monitor HR with Electrode Sleeve120
- Changing HR Beep Volume121
- Enabling HR Trace122
- Signals Overlap Verification122
- Maternal NIBP Monitoring122
- Introduction122
- How to Apply NIBP Cuff124
- Measurement Procedures125
- Auto Measurement125
- Manual Measurement126
- Changing NIBP Unit126
- Choosing NIBP Printing Mode127
- Calibrating NIBP127
- Maternal TEMP Monitoring127
- Monitoring Procedure127
- Changing TEMP Unit128
Chapter9 Monitoring Mother and Fetus Using FECG129
- Confirming Fetal Life129
- Start Monitoring129
- Introduction129
- Parts Required130
- Skin Preparation130
- Electrode Placement131
- Connecting the ECG Leads to the Electrodes132
- Placing the Transducer132
- Electrode Checking133
- Changing FECG Gain133
- Changing ECG Gain134
- Changing FECG Beep Volume134
- Monitoring Interface134
Chapter10 after Monitoring136
- Completing Monitoring136
- Switching off136
Chapter11 Maintenance And Cleaning137
- Maintenance137
- Maintaining Inspection137
- Maintenance of Monitor137
- Maintenance of Wired and Wireless Transducers137
- Storage of Recorder Paper138
- Cleaning of Recorder138
- Maintaining the Battery138
- Checking Battery Performance139
- Storing the Battery139
- Cleaning139
- Cleaning the Monitor140
- Cleaning the Reusable Accessories141
- Cleaning the Ultrasound Transducer141
- Cleaning the NIBP Cuff141
- Cleaning the ECG Cable Assembly142
- Cleaning the TOCO Transducer and Spo2 Sensor142
- Cleaning the TEMP Sensor142
- Disinfecting142
- Disinfecting the Monitor143
- Disinfecting of Reusable Accessories143
- Disinfecting the Ultrasound Transducer143
- Disinfecting the NIBP Cuff144
- Disinfecting the ECG Cable Assembly144
- Disinfecting the TOCO Transducer and Spo2 Sensor144
- Disinfecting the TEMP Sensor144
- Cleaning and Disinfecting Other Accessories144
- Storage144
Chapter12 Warranty And Service146
- Contact Information146
Appendix 1 Product Specifications147
- A F15 Fetal/Maternal Monitor147
- A1.1 Environmental Specifications147
- A1.2 Physical Specifications147
- A1.3 Performance Specifications149
- A1.4 Recorder Specifications154
- A1.5 Rechargeable Lithium-Ion Battery155
- A1.6 WIFI Specifications156
- A1.7 NFC Specifications156
- A1.8 Interface Specifications157
- A1.8.1 USB Interfaces157
- A1.8.2 Wired Network Interface157
- A1.8.3 HDMI Interface157
- A1.8.5 DB15 Interface157
Appendix 2 Signal Input/ Output Connector158
Appendix 3 Troubleshooting159
- A3.1 no Display159
- A3.2 no Touch Response159
- A3.3 Noise159
- A3.4 Recorder Error159
- A3.5 Trouble with Ultrasound FHR Monitoring160
- A3.6 Troubles with DECG Monitoring160
- A3.7 Troubles with Contractions Monitoring (External)161
- A3.8 Troubles with Contractions Monitoring (Internal)161
- A3.9 Trouble with ECG Monitoring161
- A 3.10Troubles with HR Monitoring with Electrode Sleeve162
- A3.10 no NIBP and Spo2 Results163
- A3.11 Monitor Unable to be Charged163
Appendix 4 Ultrasound Intensity and Safety164
- A4.1 Ultrasound in Medicine164
- A4.2 Ultrasound Safety and the ALARA Principle164
- A4.3 Explanation of MI/TI164
- A4.3.1 MI (Mechanical Index)164
- A4.3.2 TI (Thermal Index)164
- A4.3.3 Measurement Uncertainty165
- A4.4 Prudent Use Statement165
- A4.5 References for Acoustic Output and Safety165
- A4.6 Transducer Acoustic Output Parameters List166
- A4.6.1 Test of Wired Transducer(F15)166
- A4.6.2 Test of Wireless Transducer(F15 Air)168
- A4.6.3 Standard Parameter Equal Contrast List170
Appendix 5 Abbreviation172
Appendix 6 Ordering Information174
Appendix 7 EMC Information177
- A7.1 Electromagnetic Emissions177
- A7.2 Electromagnetic Immunity178
- A7.3 Electromagnetic Immunity181
- A7.4 Recommended Separation Distances183
Appendix 8 Limitations of Ultrasonic Monitoring184
- A8.1 How Does Ultrasound Work184
- A8.2 Artifacts in Fetal Heart Monitoring184
- A8.3 Audio Output and Screen Reading186
Appendix 9 WI-FI Networking and Instructions188
- A9.1 General188
- A9.2 Scope of Application188
- A9.3 Network Installation Process189
- A9.4 Site Survey and Network Requirements189
- A9.5 Network Design and Implementation191
- A9.5.1 Networking Scheme191
- A9.5.2 Wireless Model Network Design196
- A9.6 Continuous Transmission from Disconnection of Wireless Transducer200
- A9.7 Connecting the Monitor to MFM-CNS/ MFM-CNS Lite201

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Questions and Answers:

M
Michael BryanSep 15, 2025
What to do if my EDAN Medical Equipment monitor fails to boot?
- T
  thomasallenSep 15, 2025
  If your EDAN Medical Equipment monitor fails to boot, showing no display on the LCD, the power indicator is off, and the fan isn't running, here's what you can check: * First, ensure the power cord isn't damaged and is properly connected to both the monitor's power socket and the hospital AC outlet. * If the connections are secure and the issue persists, the main control board might be defective, requiring replacement.