EDAN F15 Series User Manual page 7

Traditional 510(k) of Fetal & Maternal Monitor
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 Other Accessories ...................................................... 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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