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Related Manuals for Flosonics Medical FloPatch FP120
Summary of Contents for Flosonics Medical FloPatch FP120
- Page 1 Part# FP120-FOT04-003 USER MANUAL For Use in the United States of America Issued June 28, 2024 FP120 Ultrasonic Blood Flow Monitor (4 MHz) 325 Front St W, Floor 4, Toronto, Ontario, Canada M5V 2Y1 info@flosonicsmedical.com flosonicsmedical.com Phone Number: +1 289-748-3711...
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Page 2: Table Of Contents
FCC Compliance Statement ....................4 Storage Conditions (Device) (Ambient) .................. 4 Battery Life .......................... 5 FLOPATCH FP120 INTENDED USE/INDICATIONS FOR USE ................5 Intended Use & Indications for Use ..................5 Intended Users ........................5 Intended Patient Population ....................5 Intended Use Environment.................... - Page 3 User Manual – FloPatch FP120 Rev 9.2 For Use in the United States of America 10. TROUBLESHOOTING ............................. 39 11. MAINTENANCE ............................. 39 12. SERVICING ..............................39 13. RETURN OR DISPOSAL ..........................39 14. SOFTWARE UPDATES ........................... 39 APPENDIX A – PRODUCT SPECIFICATIONS ......................40 APPENDIX B –...
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Page 4: Notices
User Manual – FloPatch FP120 Rev 9.2 For Use in the United States of America 1. NOTICES Caution: Federal law restricts this device to sale by or on the order of a physician. Manufacturer Contact Information Flosonics Medical (R/A 1929803 Ontario Corp.) -
Page 5: Battery Life
Intended Use & Indications for Use The FloPatch FP120 is indicated for use for the non-invasive assessment of blood flow in the carotid artery. FloPatch FP120 operates in a single mode, the Continuous Wave (CW) mode, and is not capable of operating in any other mode. -
Page 6: Safety Information
3. SAFETY INFORMATION Classification The FloPatch FP120 is classified as a portable, internally powered device. It is a medical device intended for use only by or under the order of trained medical professionals. This device is a Type BF Defibrillation Proof Applied Part. -
Page 7: Cautions
- It may compromise the integrity of the wireless connection leading to a degradation in performance of the FloPatch FP120 system. - The use of additional equipment that is not part of the FloPatch FP120 system may interfere with the performance of the FloPatch FP120 system. -
Page 8: Symbols
CAUTION! Do not try to connect the FloPatch FP120 to an incompatible mobile device, the FloPatch FP120 hardware will not be able to connect. If in the rarest of cases a connection is established, the device will not perform as intended and this may create an unknown and unforeseen hazardous situation. - Page 9 User Manual – FloPatch FP120 Rev 9.2 For Use in the United States of America the symbol is placed, or to indicate that the current situation needs operator awareness or operator action in order to avoid undesirable consequences. The device meets requirements...
- Page 10 User Manual – FloPatch FP120 Rev 9.2 For Use in the United States of America Indicates the range of humidity to Humidity which the medical device can be ISO 15223-1:2021 limitation safely exposed. Indicates the temperature limits to Temperature ISO 15223-1:2021...
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Page 11: Flopatch Fp120 Overview
FLOPATCH FP120 OVERVIEW The FloPatch FP120 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 is portable and non-invasive. The device consists of a single unit that acquires the signal and processes the signal. -
Page 12: Main Unit Diagram
User Manual – FloPatch FP120 Rev 9.2 For Use in the United States of America Main Unit Diagram Top View Angled Bottom View Bottom View JUNE 28, 2024 Page 12 / 53... -
Page 13: Basic Operation
User Manual – FloPatch FP120 Rev 9.2 For Use in the United States of America BASIC OPERATION 1. Press the power button to turn on the device. After initialization, the device LED indicator will pulse to indicate it is ready to connect to the mobile app. - Page 14 User Manual – FloPatch FP120 Rev 9.2 For Use in the United States of America 5. Peel the first liner off the back of the adhesive strap and use the end tabs to hold either end of the strap. 6. Hold the device such that the largest face of the wedge is oriented down, towards the patient’s heart.
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Page 15: Additional Adhesives
User Manual – FloPatch FP120 Rev 9.2 For Use in the United States of America 9. After securing the FloPatch, the Doppler wave trace viewed FloPatch application. Perform necessary assessments and examine the mobile app for information on patient physiology. -
Page 16: User Interface
User Manual – FloPatch FP120 Rev 9.2 For Use in the United States of America USER INTERFACE Device LEDs The FloPatch provides the user with information on its current state using LED lights. LED Color Battery Status Blue Full Amber... -
Page 17: Main Menu
User Manual – FloPatch FP120 Rev 9.2 For Use in the United States of America Main Menu The main navigation menu for the FloPatch application. It allows the user to access the core functionality of the FloPatch application. Saved Access previously recorded sessions. -
Page 18: Flopatch Connection Window
User Manual – FloPatch FP120 Rev 9.2 For Use in the United States of America FloPatch Connection Window The FloPatch Connection window, shown above on the left, appears under the following conditions: 1. One of the Start buttons is selected on the Main Menu and no FloPatch is currently connected. -
Page 19: Flopatch Info And Disconnect Window
User Manual – FloPatch FP120 Rev 9.2 For Use in the United States of America FloPatch Info and Disconnect Window The FloPatch Info window can be accessed by pressing the FloPatch Connection Info button in the bottom left corner of the app (on the Main Menu or Active Session screen) when a device is connected. -
Page 20: Active Session Screen
User Manual – FloPatch FP120 Rev 9.2 For Use in the United States of America Active Session Screen The Active Session screen is where the Doppler information taken from the FloPatch is displayed graphically to the user. This screen is the core functional part of the FloPatch application and has several features. In... - Page 21 User Manual – FloPatch FP120 Rev 9.2 For Use in the United States of America Assessment Displays the current stage in the assessment workflow. This workflow consists Stage of 3 stages: The user can navigate in succession through these 3 stages using the Assessment Stage buttons.
- Page 22 User Manual – FloPatch FP120 Rev 9.2 For Use in the United States of America Pre and Post Green (pre-intervention) and blue (post-intervention) sliding bars appear after Intervention selecting the Collect Baseline button for the metrics Max Total VTI and Corrected Sliders Flow Time.
- Page 23 User Manual – FloPatch FP120 Rev 9.2 For Use in the United States of America Pre and Post Allows the user to toggle between different window sizes of 10 seconds, 20 Intervention seconds, or 30 seconds in length. The change calculations will automatically Window Size update based on all the data highlighted in these windows.
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Page 24: Guided Assessment Screen
User Manual – FloPatch FP120 Rev 9.2 For Use in the United States of America Guided Assessment Screen The Guided Session screen is also where the Doppler information taken from the FloPatch is displayed graphically to the user but differs from the Active Session Screen. This screen is the core functional part of the FloPatch application and has several features. - Page 25 User Manual – FloPatch FP120 Rev 9.2 For Use in the United States of America Workflow The Guided Assessment will guide the user through the following 7 steps, Status which will be indicated by the Workflow Status bar. A loading bar will be displayed while collecting data to indicate how much data needs to be recorded before moving to the next stage in the workflow.
- Page 26 User Manual – FloPatch FP120 Rev 9.2 For Use in the United States of America Marks the point in time at which the assessment was completed. Data will Assessment continue to be collected after this point in time until the session is ended, or...
- Page 27 User Manual – FloPatch FP120 Rev 9.2 For Use in the United States of America Manual/ Allows the user to toggle between the following two modes for analyzing the Smart Data data: Selection 1) Smart Selection Smart Selection provides the user with automated data analysis by selecting statistically relevant sections of the data collected in the baseline and post- intervention stages of the assessment.
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Page 28: Saved Sessions Screen
User Manual – FloPatch FP120 Rev 9.2 For Use in the United States of America Saved Sessions Screen The Saved Sessions screen allows the user to load previously recorded data into a session review screen. The individual sessions can be identified by: 1. -
Page 29: Session Review Screen For An Active Session
User Manual – FloPatch FP120 Rev 9.2 For Use in the United States of America 7.7.1 Session Review Screen for an Active Session Pre and Post The top half of the screen shows the waveform of the selected pre Waveform (1a) and post (1b) regions. - Page 30 User Manual – FloPatch FP120 Rev 9.2 For Use in the United States of America Enhanced Opens an enlarged spectrogram image with additional zoom/pan Spectrogram control. Review Save Session Save any changes made to the session data. Metric Console Covers the lower half of the screen and displays the calculated metric as bars, with one bar corresponding to one heartbeat.
- Page 31 User Manual – FloPatch FP120 Rev 9.2 For Use in the United States of America Doppler Mode Provides the user with an additional waveform display and allows them to toggle between: 1) Spectrogram (raw Doppler waveform with the trace 2) Forward Spectrogram (raw Doppler forward waveform)
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Page 32: Session Review Screen For A Guided Session
User Manual – FloPatch FP120 Rev 9.2 For Use in the United States of America 7.7.2 Session Review Screen for a Guided Session Pre and Post The top half of the screen shows the waveform of the selected pre Waveform (1a) and post (1b) regions. - Page 33 User Manual – FloPatch FP120 Rev 9.2 For Use in the United States of America Save Session Save any changes made to the session data. Metric Console Covers the lower half of the screen and displays the calculated metric as bars, with one bar corresponding to one heartbeat. The user can toggle between different metrics using the Console Mode button.
- Page 34 User Manual – FloPatch FP120 Rev 9.2 For Use in the United States of America Smart or Allows the user to toggle between Smart or Manual windows. When Manual Manual windows are toggled on, the user will be able to manually select Windows the data being used for calculations.
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Page 35: Peak Velocity Alert
User Manual – FloPatch FP120 Rev 9.2 For Use in the United States of America Peak Velocity Alert Peak Velocity Alert is displayed when peak measured blood velocity is outside of the device’s maximum velocity range. Signal Strength Indicator Signal Strength Indicator is displayed when the signal quality is too poor to produce a maximum velocity trace. -
Page 36: Doppler Angle Indicator
User Manual – FloPatch FP120 Rev 9.2 For Use in the United States of America 7.10 Doppler Angle Indicator Doppler Angle Indicator is displayed when the FloPatch wedge angle relative to the blood vessel is not optimal for signal detection. When this is the case, the trace will continue to be displayed but it is recommended the FloPatch wedge angle be adjusted for best performance. -
Page 37: Wireless Connection Performance
FloPatch device. Cyber-Security FloPatch FP120 uses a Bluetooth Low Energy wireless communication protocol to transmit physiological signal data from the sensor to a monitoring apparatus. All wireless devices are exposed to some risk of cyber-attack. If the user suspects that the sensor’s data stream is compromised, they can confirm signal fidelity by performing auditory Doppler shift test and mechanical tap test as outlined below. - Page 38 Doppler shift data in real-time, in such a way that the data could be interpreted by the FloPatch FP120 software, and if interpreted by the software, be mistaken for physiologically relevant data by the clinical end user. In the unlikely event that the BLE data stream was thought to be compromised, the clinician could perform the sensor-tap test to verify the fidelity of the data through instantaneous audible and visual feedback from the device.
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Page 39: Troubleshooting
5) Ensure that the device is oriented correctly. 6) Ensure the volume is turned up in the FloPatch FP120 application No FloPatch FP120 Ensure FloPatch FP120 device is powered on and in range of the iPad. devices detected in the connection screen If any of the above solutions do not resolve the issue, please contact the manufacturer. -
Page 40: Appendix A - Product Specifications
User Manual – FloPatch FP120 Rev 9.2 For Use in the United States of America Appendix A – Product Specifications Product Name FloPatch FP120 Model Number FP120 Standards Compliance IEC 60601-1 IEC 60601-2-37 IEC 60601-1-2 Battery Specification Lithium Polymer (IEC 62133) -
Page 41: Appendix B - Compatible Mobile Devices & Wireless Information
User Manual – FloPatch FP120 Rev 9.2 For Use in the United States of America Appendix B – Compatible Mobile Devices & Wireless Information Compatible Mobile Devices iPad Air (4th generation) (2020): A2316 iPad Air (5th generation) (2022): A2588 iPad Mini (6th generation) (2021): A2567 iPad Pro (12.9”... -
Page 42: Appendix C - Emc Information
Section 2.4 of this user manual. Emissions Class and Group Compliance The FloPatch FP120 is intended for use in the electromagnetic environment specified below. The customer or the user of the FloPatch FP120 should assure that it is used in such an environment. Emissions Test... -
Page 43: Electromagnetic Environment - Guidance
The FloPatch FP120 is intended for use in the electromagnetic environment specified below. The customer or the user of the FloPatch FP120 should assure that it is used in such an environment. -
Page 44: Device Immunity To Proximal Rf Emitters
C.3 Device immunity to proximal RF emitters The FloPatch FP120 has been tested to and complies with requirements for Enclosure Port Immunity to RF Wireless Communication Equipment laid out in IEC 60601-1-2:2014, Table 9. The device was subjected to a field strength of 3 V/m (80% AM) for frequency range of 80MHz –... -
Page 45: Recommended Separation Distances
Recommended separation distances between portable and mobile RF communications equipment and the FloPatch FP120 The FloPatch FP120 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the FloPatch FP120 can help prevent... -
Page 46: Emc Note
C.5 EMC Note If the FloPatch FP120 system is operated within the EMC environment described in Appendix C the device will maintain essential performance and provide the following within specifications: 1. Doppler Audio and Waveforms Display 2. -
Page 47: Appendix D - Ultrasound Intensity And Safety
No time limit The FloPatch FP120 has a TIS average of 1.39 with an upper bound of 2.46 or 0.88 with an upper bound of 1.72 for a reprocessed device (FP120R). Based on the upper bound the recommended max dwell time would be less than 60 minutes. -
Page 48: Explanation Of Mi/Ti
Rev 9.2 For Use in the United States of America During simulated use testing the FloPatch FP120 caused a temperature rise of 1.9-2.7°C. The upper limit of 2.7°C is used in the calculation below. ���� = 10^[0.6 ∗ ( 6 − 2.7 ) ] ����... - Page 49 User Manual – FloPatch FP120 Rev 9.2 For Use in the United States of America Whether the sources of the uncertainties in the measurement are random or systematic, or more formally, Type A or Type B, they may be combined into an overall assessment of measurement uncertainty. The analysis of the Type B uncertainties below should be combined with the statistically derived Type A measurements on a root sum squared basis.
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Page 50: Prudent Use Statement
Edition 2.1 published in 2015. The FloPatch FP120 is a Track 3 device based on the FDA Guidance “Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Devices.”... -
Page 51: Iec 60601-2-37, Ed 2.1 Reporting Table
User Manual – FloPatch FP120 Rev 9.2 For Use in the United States of America D.3.7 IEC 60601-2-37, Ed 2.1 Reporting Table FP120 Index label Below Below surface surface surface surface Maximum index value 5.22E-02 1.39 2.21 3.03 Index component value 0.97... - Page 52 User Manual – FloPatch FP120 Rev 9.2 For Use in the United States of America NOTE 5 If the requirements of 201.12.4.2b) are met, it is not required to enter any data in the column related to MI. NOTE 6 Unshaded cells should have a numerical value.
- Page 53 User Manual – FloPatch FP120 Rev 9.2 For Use in the United States of America NOTE 2 Data should be entered for "at surface" and "below surface" both in the columns related to TIS or TIB. NOTE 3 Information need not be provided regarding TIC for an TRANSDUCER ASSEMBLY not intended for transcranial or neonatal cephalic uses.
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