Name: EDAN F15 Series
Brand: EDAN
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F15 Series Fetal & Maternal Monitor User Manual Safety Guidance

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The user manual is printed in black and white.

Traditional 510(k) of Fetal & Maternal Monitor

014_14.1_F15_Series_User_Manual

23／202

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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Brand	EDAN
Model	F15 Series
Category	Monitor
Language	English

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