Flosonics Medical FloPatch FP120 User Manual Download Page 1

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CONFIDENTIAL

UNCONTROLLED UNLESS OTHERWISE SIGNED AND/OR STAMPED.

Page 1 / 33

USER MANUAL

FP120

Ultrasonic Blood Flow Monitor

(4 MHz)

204-73 Elm St, Unit

Sudbury, Ontario P3C 1R7

Canada

[email protected]

flosonicsmedical.com

Summary of Contents for FloPatch FP120

Page 1: ...NCONTROLLED UNLESS OTHERWISE SIGNED AND OR STAMPED Page 1 33 USER MANUAL FP120 Ultrasonic Blood Flow Monitor 4 MHz 204 73 Elm St Unit Sudbury Ontario P3C 1R7 Canada info flosonicsmedical com flosonics...

Page 2: ...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 FloPat...

Page 3: ...NED AND OR STAMPED Page 3 33 9 7 1 Mechanical Index MI 29 9 7 2 TI Thermal Index 29 9 7 3 Measurement Uncertainties 30 9 7 4 Prudent Use Statement 31 9 7 5 References for Acoustic Output Safety 31 9 7...

Page 4: ...to comply with the limits for a Class B digital device pursuant to part 15 of the FCC Rules These limits are designed to provide reasonable protection against harmful interference in a residential ins...

Page 5: ...romettre le fonctionnement CAN ICES 3 B NMB 3 B RF Exposure Statement This equipment complies with ISED RSS 102 radiation exposure limits set forth for an uncontrolled environment Cet quipement est co...

Page 6: ...be used in oxygen rich and in the presence of flammable anesthetics WARNING The device is intended for intact skin only Do not use the device on or near open wounds WARNING The device is not intended...

Page 7: ...ne 3 4 Symbols Labelling Presentation Reference Title of Symbol Notes ISO 7010 M002 Consult Instructions for Use IFU This indicates that the Instructions for use must be consulted before using this de...

Page 8: ...20 is a non invasive blood flow evaluation device to be used in a medical hospital setting for use by a trained medical professional The FloPatch FP120 is a hands free wearable ultrasound device that...

Page 9: ...IDENTIAL UNCONTROLLED UNLESS OTHERWISE SIGNED AND OR STAMPED Page 9 33 4 1 Main Unit Diagram Ultrasound gel to be applied liberally on wide face of probe geometry Ultrasound probe face On Off Button S...

Page 10: ...tion with the mobile app 2 Open the mobile app and navigate to the Assess Bloodflow screen Press the button in the bottom left corner to open a list of devices available to connect Select the desired...

Page 11: ...identified carotid artery Ensure the logos images are right side up When the device is placed the Doppler sound will begin to be heard from the mobile app 6 Ensure a satisfactory Doppler sound and wa...

Page 12: ...e screen and press the disconnect button on the screen that appears The FloPatch may remain secured to the patient to allow for reassessment 11 To perform subsequent assessments repeat Steps 1 2 to re...

Page 13: ...application is opened from being closed It prompts the user to select one of four options 1 Start navigates the user to the Home Screen of the FloPatch iOS application 2 Frequently Asked Questions ope...

Page 14: ...ess blood flow window if a FloPatch is already connected to the iOS device If no FloPatch is connected the FloPatch connection screen will appear see section 7 3 More information about the Assess Bloo...

Page 15: ...oPatch is currently connected 2 A FloPatch is manually disconnected from the Assess Blood Flow screen and connect is selected The FloPatch connections screen allows you to connect a FloPatch by select...

Page 16: ...eral parts In the above image the parts of the screen are labeled 1 14 and information about each component can be found below 1 The Return Button returns the iOS application back to the Home Screen o...

Page 17: ...sment State button group controls the assessment state 3 of the iOS application There are three buttons in the assessment state button group 7a Collect Baseline 7b Begin Assessment 7c End Assessment T...

Page 18: ...eft side of this component as a value from 1 to 4 Selecting this button opens a pop up containing the ID and device information for the connected FloPatch as well as an option to disconnect the curren...

Page 19: ...creen The individual assessments can be identified by three features 1 The unique assessment ID 2 The duration of the assessment 3 The date and time of the recording A session may be deleted or loaded...

Page 20: ...Total VTI and Corrected Flow Time 3 The Pre and Post Assessment Sliders 3a and 3b allow you to calculate the percent change between areas in the saved assessment 4 The Percent Change Area displays th...

Page 21: ...device is displayed on the disconnect screen 7 TROUBLESHOOTING THE FLOPATCH Issue Solution Device is damaged Contact the manufacturer or return the device to manufacturer and stop all usage of the dev...

Page 22: ...e any calibration Ensure the device has no visible damage before using it If any damage is evident stop all usage of the device and contact the manufacturer Do not reuse devices They are intended for...

Page 23: ...Equipment Applied Part Type B Degree of Protection Against Harmful Ingress of Fluid IPx7 Degree of Safety in Presence of Flammable Anaesthetics Equipment not suitable for use in presence of flammable...

Page 24: ...FloPatch FP120 Rev 1 0 CONFIDENTIAL UNCONTROLLED UNLESS OTHERWISE SIGNED AND OR STAMPED Page 24 33 Appendix B Compatible Mobile Devices iPad Pro Models A1980 A1876 iPad Air Gen 3 Models A2152 iOS Ver...

Page 25: ...for use in all establishments other than domestic and may be used in domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used fo...

Page 26: ...uptions and voltage variations on power supply input lines IEC 61000 4 11 0 UT 100 dip in UT for 1 cycle s 70 UT 30 dip in UT for 30 cycles 0 UT 100 dip in UT for 5 sec Not Applicable Not Applicable P...

Page 27: ...in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site surve...

Page 28: ...73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be estimated using the equation app...

Page 29: ...inciple 9 7 Explanation of MI TI 9 7 1 Mechanical Index MI Scientific evidence suggests that mechanical or nonthermal bioeffects such as cavitation are threshold phenomena occurring only when a certai...

Page 30: ...ned with the statistically derived Type A measurements on a root sum squared basis 1 Voltage V oscilloscope 2 9 The two contributing sources were the stated DC gain accuracy and digitization error of...

Page 31: ...Document issued on October 2 2017 by the FDA 4 IEC 60601 2 37 Medical electrical equipment Part 2 37 Particular requirements for the basic safety and essential performance of ultrasonic medical diagno...

Page 32: ...quirements of 201 12 4 2a are met it is not required to enter any data in the columns related to TIS TIB or TIC NOTE 5 If the requirements of 201 12 4 2b are met it is not required to enter any data i...

Page 33: ...MPED Page 33 33 Ipa Attenuated pulse average intensity Ispta Spatial peak temporal average intensity spatial peak temporal average intensity srr Scan repetition rate pr Peak acoustic pressure npps Num...

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