Table of Contents
Summary of Contents for Flosonics Medical FloPatch FP120
- Page 1 USER MANUAL FP120 Ultrasonic Blood Flow Monitor (4 MHz) 204-73 Elm St, Unit Sudbury, Ontario P3C 1R7 Canada info@flosonicsmedical.com flosonicsmedical.com CONFIDENTIAL UNCONTROLLED UNLESS OTHERWISE SIGNED AND/OR STAMPED. Page 1 / 33...
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Page 2: Table Of Contents
User Manual – FloPatch FP120 Rev 1.0 Table of Contents NOTICES ................................. 4 Caution: Federal law restricts this device to sale by or on the order of a physician....4 Manufacturer Contact Information ..................4 FCC Compliance Statement ....................4 Industry Canada Compliance .................... - Page 3 User Manual – FloPatch FP120 Rev 1.0 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 9.7.6 Summary of Global Max Values ..................31 9.7.7...
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Page 4: Notices
User Manual – FloPatch FP120 Rev 1.0 NOTICES Caution: Federal law restricts this device to sale by or on the order of a physician. Manufacturer Contact Information Flosonics Medical (o/a 1929803 Ontario Corp.) 204-73 Elm Street Sudbury, Ontario P3C 1R7 Canada info@flosonicsmedical.com... -
Page 5: Industry Canada Compliance
User Manual – FloPatch FP120 Rev 1.0 Industry Canada Compliance IC: 25612-FP120 This device complies with Industry Canada license-exempt RSS standard(s). Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device. -
Page 6: Safety Information
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. The device used with this device is a Type B Defibrillation Proof Applied Part. -
Page 7: Cautions
User Manual – FloPatch FP120 Rev 1.0 Cautions Icon Explanation CAUTION! Federal law restricts this device to sale by or on the order of a physician. CAUTION! Use only manufacturer-provided devices and parts. CAUTION! Do not alter the device or provided components. -
Page 8: Flopatch Overview
User Manual – FloPatch FP120 Rev 1.0 Indicates a medical device that should not be Do Not Use if Package is ISO 7000-2606 used if the package has Damaged been damaged or opened. It indicates a medical device that can be... -
Page 9: Main Unit Diagram
User Manual – FloPatch FP120 Rev 1.0 Main Unit Diagram On/Off Button Skin contacting Adhesive Liner Pull Tabs Ultrasound gel to be applied liberally on wide face of probe geometry. Ultrasound probe face CONFIDENTIAL UNCONTROLLED UNLESS OTHERWISE SIGNED AND/OR STAMPED. -
Page 10: Basic Operation
User Manual – FloPatch FP120 Rev 1.0 BASIC OPERATION 1. Press the power button to initiate the device. Upon initiation, the device LED indicator will blink rapidly to indicate it is ready to establish a connection with the mobile app. - Page 11 User Manual – FloPatch FP120 Rev 1.0 4. Locate the carotid artery in the neck using palpation. 5. Place the FloPatch lengthways across the neck, directly on top of the previously 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.
- Page 12 User Manual – FloPatch FP120 Rev 1.0 7. Continue to hold the FloPatch securely over the carotid and pull the liner tight to apply tension over the skin. Once applied tightly to the skin, pull sufficiently to rip the liner off the end of the adhesive.
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Page 13: User Interface
User Manual – FloPatch FP120 Rev 1.0 User Interface Welcome Screen The Welcome Screen is the first window a user can interact with when using the FloPatch iOS application. It will be the first page displayed when the application is opened from being closed. It prompts the user to... -
Page 14: Home Screen
User Manual – FloPatch FP120 Rev 1.0 Home Screen The Home Screen is the main navigation menu for the FloPatch iOS application. It allows the user to access the core functionality of the FloPatch application through its three buttons: Assess Blood Flow launches the assess blood flow window if a FloPatch is already connected to the iOS device. -
Page 15: Flopatch Connection Screen
User Manual – FloPatch FP120 Rev 1.0 FloPatch Connection Screen The FloPatch Connection screen appears under the following conditions: Assess Blood Flow 1. The button is selected on the Home Screen and no FloPatch is currently connected 2. A FloPatch is manually disconnected from the Assess Blood Flow screen and... -
Page 16: Assess Blood Flow Screen
User Manual – FloPatch FP120 Rev 1.0 Assess Blood Flow Screen The Assess Blood Flow 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 iOS application and has several parts. - Page 17 User Manual – FloPatch FP120 Rev 1.0 The following table displays the workflow of changing assessment states: State Triggered by Button Minimum Duration of State Ended by Button Baseline 30 seconds Assessment 30 seconds Analysis No time limit When the Assess Blood Flow screen first opens, the only selectable button is 7a,...
- Page 18 User Manual – FloPatch FP120 Rev 1.0 of data is calculated, it is displayed on the right most side of the characteristics display in a yellow box (10c). FloPatch Connection Information 11. The displays the connection status information for the FloPatch to the user.
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Page 19: Saved Assessments Screen
User Manual – FloPatch FP120 Rev 1.0 Saved Assessments Screen The Saved Assessments Screen allows the user to load previous assessments taken from the Assess Blood Flow screen. The individual assessments can be identified by three features: 1. The unique assessment ID 2. - Page 20 User Manual – FloPatch FP120 Rev 1.0 The Saved Assessments window has a few features to note: Return 1. The button returns you to the main Saved Assessments window Select Metric 2. The arrows allow you to toggle between Max Total VTI and Corrected Flow Time Pre and Post Assessment Sliders 3.
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Page 21: Troubleshooting The Flopatch
Assess Blood Flow Screen. Disconnect FloPatch 1. The button when pressed, disconnects a connected FloPatch FP120 device. 2. Hardware and Firmware information of the connected FloPatch FP120 device is displayed on the disconnect screen. TROUBLESHOOTING THE FLOPATCH Issue... -
Page 22: Maintenance
User Manual – FloPatch FP120 Rev 1.0 4) Ensure that the device is oriented correctly. If any of the above solutions do not resolve the issue, contact the manufacturer. MAINTENANCE The device or the main unit do not require any calibration. Ensure the device has no visible damage before using it. -
Page 23: Appendix A - Product Specifications
User Manual – FloPatch FP120 Rev 1.0 Appendix A – Product Specifications Product Name FloPatch FP120 Model Number FP120 Standards Compliance IEC 60601-1, IEC 60601-2-37 and IEC 60601-1-2. Battery Specifications Lithium Polymer, IEC 62133 Classification ME Classification (IEC 60601-1): Internally Powered Equipment... -
Page 24: Appendix B - Compatible Mobile Devices
User Manual – FloPatch FP120 Rev 1.0 Appendix B – Compatible Mobile Devices iPad Pro Models: A1980, A1876 iPad Air Gen 3 Models: A2152 iOS Version: iOS 12+ CONFIDENTIAL UNCONTROLLED UNLESS OTHERWISE SIGNED AND/OR STAMPED. Page 24 / 33... -
Page 25: Appendix C - Emc Information
The user might need to take mitigation measures, such as relocating or re-orienting the equipment. 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 26 User Manual – FloPatch FP120 Rev 1.0 ±0.5 kV, ±1 kV line to line & ±0.5 kV, ±1 kV, ±2 kV line to ground Not Applicable Not Applicable Surge IEC 61000-4-5 (100% dip in ) for 0,5 cycle (100% dip in...
- Page 27 To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the FloPatch FP120 is used exceeds the applicable RF compliance level above, the FloPatch FP120 should be observed to verify normal operation.
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Page 28: 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 electromagnetic interference by... -
Page 29: Appendix D - Ultrasound Intensity And Safety
User Manual – FloPatch FP120 Rev 1.0 Appendix D – Ultrasound Intensity and Safety Ultrasound in Medicine The use of diagnostic ultrasound has proved to be a valuable tool in medical practice. Given its known benefits for non-invasive investigations and medical diagnosis, including investigation of the human fetus, the question of clinical safety with regards to ultrasound intensity arises. -
Page 30: Measurement Uncertainties
User Manual – FloPatch FP120 Rev 1.0 3. TIC (Thermal Index for cranial applications): It provides an estimate of potential temperature rise in the cranial bones or superficial bones. 9.7.3 Measurement Uncertainties The devices used in the measurement (hydrophone, oscilloscope) have systematic errors associated with their use, either by calibration uncertainty or design limitations. -
Page 31: Prudent Use Statement
User Manual – FloPatch FP120 Rev 1.0 9.7.4 Prudent Use Statement Although no confirmed bioeffects on patients caused by exposure from present diagnostic ultrasound equipment have ever been reported, the potential exists that such bioeffects may be identified in the future. Therefore, the ultrasound should be used prudently. High levels of acoustic output and long exposure time should be avoided while acquiring necessary clinical information. - Page 32 User Manual – FloPatch FP120 Rev 1.0 (MHz) 4.03 4.03 4.03 4.03 fawf (Hz) (Hz) npps Ipa, α at (W/c zpii,α Other Ispta,α at (mW/ Information zpii,α or 15.78 zsii,α Ispta at zpii (mW/ 33.07 or zsii 3.24E (MPa) pr at zpii...
- Page 33 User Manual – FloPatch FP120 Rev 1.0 Attenuated pulse-average intensity pa,α Spatial-peak temporal-average intensity spatial-peak temporal-average intensity spta Scan repetition rate Peak acoustic pressure Number of pulses per ultrasonic scan line Distance between a hydrophone and an ultrasonic device CONFIDENTIAL UNCONTROLLED UNLESS OTHERWISE SIGNED AND/OR STAMPED.