User Manual –FloPatch FP120 Rev 1.0
CONFIDENTIAL UNCONTROLLED UNLESS OTHERWISE SIGNED AND/OR STAMPED. Page 2 / 33
Table of Contents
1. NOTICES .........................................................................................................................................................4
1.1 Caution: Federal law restricts this device to sale by or on the order of a physician. ..................4
1.2 Manufacturer Contact Information.........................................................................................4
1.3 FCC Compliance Statement ...................................................................................................4
1.4 Industry Canada Compliance.................................................................................................5
2. FLOPATCH INTENDED USE/INDICATIONS FOR USE .........................................................................................5
2.1 Intended Use .......................................................................................................................5
2.2 Intended Users ....................................................................................................................5
2.3 Intended Patient Population ..................................................................................................5
2.4 Intended Use Environment....................................................................................................5
2.5 Contraindications..................................................................................................................5
3. SAFETY INFORMATION...................................................................................................................................6
3.1 Classification ........................................................................................................................6
3.2 Warnings .............................................................................................................................6
3.3 Cautions ..............................................................................................................................7
3.4 Symbols...............................................................................................................................7
4. FLOPATCH OVERVIEW ....................................................................................................................................8
4.1 Main Unit Diagram................................................................................................................9
5. BASIC OPERATION........................................................................................................................................ 10
6. USER INTERFACE .......................................................................................................................................... 13
6.1 Welcome Screen ................................................................................................................13
6.2 Home Screen .....................................................................................................................14
6.3 FloPatch Connection Screen ................................................................................................15
6.4 Assess Blood Flow Screen ...................................................................................................16
6.5 Saved Assessments Screen .................................................................................................19
7. TROUBLESHOOTING THE FLOPATCH............................................................................................................. 21
8. MAINTENANCE............................................................................................................................................. 22
9. SERVICING.................................................................................................................................................... 22
APPENDIX A –PRODUCT SPECIFICATIONS............................................................................................................ 23
APPENDIX B –COMPATIBLE MOBILE DEVICES...................................................................................................... 24
APPENDIX C –EMC INFORMATION ...................................................................................................................... 25
9.1 Electromagnetic Emissions ..................................................................................................25
9.2 Electromagnetic Immunity ..................................................................................................25
9.3 Recommended Separation Distances ...................................................................................28
9.4 EMC Note: .........................................................................................................................28
APPENDIX D –ULTRASOUND INTENSITY AND SAFETY.......................................................................................... 29
9.5 Ultrasound in Medicine .......................................................................................................29
9.6 Ultrasound Safety and the ALARA Principle ..........................................................................29
9.7 Explanation of MI/TI...........................................................................................................29
