USER MANUAL TM 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.
User Manual – FloPatch FP120 Rev 1.0 Table of Contents 1. 2. 3. 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 .........
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 ...........................................
User Manual – FloPatch FP120 1. Rev 1.0 NOTICES 1.1 Caution: Federal law restricts this device to sale by or on the order of a physician. 1.2 Manufacturer Contact Information Flosonics Medical (o/a 1929803 Ontario Corp.) 204-73 Elm Street Sudbury, Ontario P3C 1R7 Canada info@flosonicsmedical.com 1.3 FCC Compliance Statement FCC ID: 2AUWSFP120 This device complies with Part 15 of the FCC Rules.
User Manual – FloPatch FP120 1.4 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. Le présent appareil est conforme aux CNR d'Industrie Canada applicables aux appareils radio exempts de licence.
User Manual – FloPatch FP120 3. Rev 1.0 SAFETY INFORMATION 3.1 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. Personnel operating this device are responsible for reading and thoroughly understanding all accompanying documents.
User Manual – FloPatch FP120 3.3 Icon Rev 1.0 Cautions 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. CAUTION! Do not attempt to service the device. In the event the device malfunctions, please contact the manufacturer. CAUTION! Keep the device dry. CAUTION! Do not sterilize the device.
User Manual – FloPatch FP120 IPX7 4. ISO 7000-2606 Do Not Use if Package is Damaged ISO 7000-0621 Fragile, Handle with Care ISO 7000-2609 Non-Sterile IEC 60529 IP Rating Rev 1.0 Indicates a medical device that should not be used if the package has been damaged or opened. It indicates a medical device that can be broken or damaged if not handled carefully. This indicates a medical device that has not been subjected to a sterilization process.
User Manual – FloPatch FP120 4.1 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.
User Manual – FloPatch FP120 5. 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. 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.
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. 6. Ensure a satisfactory Doppler sound and waveform from the mobile app (i.e.
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. 8. Repeat Steps 6-7 for the liner on the opposite side. 9. After securing the FloPatch, the Doppler wave trace can be viewed on the mobile application. Perform any necessary assessments and examine the mobile app for information on patient physiology. 10.
User Manual – FloPatch FP120 6. 6.1 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 select one of four options: 1. Start navigates the user to the Home Screen of the FloPatch iOS application 2. Frequently Asked Questions opens up a list of FAQs’ to help answer any questions the user might have 3.
User Manual – FloPatch FP120 6.2 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: 1. Assess Blood Flow launches the assess 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).
User Manual – FloPatch FP120 6.3 Rev 1.0 FloPatch Connection Screen The FloPatch Connection screen appears under the following conditions: 1. The Assess Blood Flow 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 connect is selected The FloPatch connections screen allows you to connect a FloPatch by selecting connect.
User Manual – FloPatch FP120 6.4 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. 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 of the iOS application. 2.
User Manual – FloPatch FP120 Rev 1.0 The following table displays the workflow of changing assessment states: State Baseline Assessment Analysis Triggered by Button 7a 7b - Minimum Duration of State 30 seconds 30 seconds No time limit Ended by Button 7b 7c - When the Assess Blood Flow screen first opens, the only selectable button is 7a, Collect Baseline.
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). 11. The FloPatch Connection Information displays the connection status information for the FloPatch to the user. This includes the battery level, which is displayed graphically as a battery with green charge units. Additionally, the Bluetooth connection strength is displayed on the left side of this component, as a value from 1 to 4.
User Manual – FloPatch FP120 6.5 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. The duration of the assessment 3. The date and time of the recording A session may be deleted or loaded by the user. If deleted, the session cannot be recovered.
User Manual – FloPatch FP120 Rev 1.0 The Saved Assessments window has a few features to note: 1. The Return button returns you to the main Saved Assessments window 2. The Select Metric arrows allow you to toggle between Max 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 the percentage change between the pre and post assessment sliders 5.
User Manual – FloPatch FP120 6.6 Rev 1.0 Disconnect Screen 2 1 The disconnect screen appears when a FloPatch device is connected to the mobile medical application and the button is pressed on the Assess Blood Flow Screen. 1. The Disconnect FloPatch 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. 7.
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. 8. MAINTENANCE The device or the main unit do not require 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 a single use on a single subject only.
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.
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.
User Manual – FloPatch FP120 Rev 1.0 Appendix C – EMC Information 9.1 Electromagnetic Emissions NOTE: The emissions characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 Class A). If used in a residential environment (for which CISPR 11 Class B is normally required) this equipment may not offer adequate protection to radio-frequency communication services. The user might need to take mitigation measures, such as relocating or re-orienting the equipment.
User Manual – FloPatch FP120 Surge IEC 61000-4-5 Voltage Dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 Power Frequency Magnetic Field (50/60 Hz) ±0.5 kV, ±1 kV line to line & ±0.5 kV, ±1 kV, ±2 kV line to ground 0% UT (100% dip in UT) for 0,5 cycle Rev 1.
User Manual – FloPatch FP120 Rev 1.0 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.
User Manual – FloPatch FP120 9.3 Rev 1.0 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.
User Manual – FloPatch FP120 Rev 1.0 Appendix D – Ultrasound Intensity and Safety 9.5 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. There is no easy answer to the question of safety surrounding the use of diagnostic ultrasound equipment.
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. These are noted below and were not associated with statisti- cal analysis; they are therefore Type B uncertainties.
User Manual – FloPatch FP120 9.7.4 Rev 1.0 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. 9.7.5 References for Acoustic Output Safety 1.
User Manual – FloPatch FP120 fawf (MHz) 4.03 prr (Hz) N/A srr (Hz) N/A Operating control conditions 4.03 4.03 1 npps Other Information 4.03 Rev 1.0 Ipa, α at zpii,α (W/c m2 ) N/A Ispta,α at zpii,α or zsii,α (mW/ cm2) 15.78 Ispta at zpii or zsii (mW/ cm2) 33.07 pr at zpii (MPa) 3.24E -02 CW-mode NOTE 1 Only one operating condition per index. NOTE 2 Data should be entered for "at surface" and "below surface" both in the columns related to TIS or TIB.
User Manual – FloPatch FP120 Ipa,α Ispta srr pr npps z CONFIDENTIAL Rev 1.0 Attenuated pulse-average intensity Spatial-peak temporal-average intensity spatial-peak temporal-average intensity Scan repetition rate Peak acoustic pressure Number of pulses per ultrasonic scan line Distance between a hydrophone and an ultrasonic device UNCONTROLLED UNLESS OTHERWISE SIGNED AND/OR STAMPED.
