CONFIDENTIAL
UNCONTROLLED UNLESS OTHERWISE SIGNED AND/OR STAMPED.
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USER MANUAL
FP120
Ultrasonic Blood Flow Monitor
(4 MHz)
204-73 Elm St, Unit
Sudbury, Ontario P3C 1R7
Canada
[email protected]
flosonicsmedical.com
TM
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
Страница 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...
