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Ultrasonic Blood Flow Monitor
UNCONTROLLED UNLESS OTHERWISE SIGNED AND/OR STAMPED.
USER MANUAL
For Use in the United States of America
FP120
(4 MHz)
325 Front St W, Floor 4,
Toronto, Ontario,
Canada M5V 2Y1
info@flosonicsmedical.com
flosonicsmedical.com
Phone Number: +1 705-626-6419
Part# FP120-FOT04-003
T
TM
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Table of Contents
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 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: +1 705-626-6419 UNCONTROLLED UNLESS OTHERWISE SIGNED AND/OR STAMPED. Page 1 / 41...
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Page 2: Table Of Contents
Manufacturer Contact Information ..................4 FCC Compliance Statement ....................4 Industry Canada Compliance ....................5 Storage Conditions (Device) (Ambient) .................. 5 FLOPATCH FP120 INTENDED USE/INDICATIONS FOR USE ................5 Intended Use ........................5 Intended Users ........................5 Intended Patient Population ....................5 Intended Use Environment.................... - Page 3 User Manual – FloPatch FP120 Rev 2.0 For Use in the United States of America 14.1 Electromagnetic Emissions ....................32 14.2 Electromagnetic Immunity ....................32 14.3 Device immunity to proximal RF emitters ................34 14.4 Recommended Separation Distances ................... 35 14.5...
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Page 4: Notices
User Manual – FloPatch FP120 Rev 2.0 For Use in the United States of America 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: Industry Canada Compliance
FLOPATCH FP120 INTENDED USE/INDICATIONS FOR USE Intended 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: Indications For Use
For Use in the United States of America 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 7: 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 8: Warnings
- 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 part of the FloPatch FP120 system may interfere with the performance of the FloPatch FP120 system. - Page 9 WARNING! Flosonics Medical explicitly recommends against using additional equipment which is not part of the FloPatch FP120 system. Doing so may create an unforeseen hazardous situation. WARNING! The FloPatch FP120 device in not cleared for use in Domestic environments.
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Page 10: Cautions
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 11: Symbols
User Manual – FloPatch FP120 Rev 2.0 For Use in the United States of America Symbols Labelling Reference Title of Notes Presentation Symbol Consult This indicates that the Instructions for use ISO 7010-M002 Instructions must be consulted before using this device. -
Page 12: Flopatch Fp120 Overview
FLOPATCH FP120 MOBILE MEDICAL APPLICATION The primary function of the FloPatch FP120 is to process and display the Doppler signal received from the FloPatch FP120 hardware. The application is not designed for and should not be used for any purpose other than the intended use of the FloPatch FP120 system. -
Page 13: Main Unit Diagram
User Manual – FloPatch FP120 Rev 2.0 For Use in the United States of America Main Unit Diagram ON/OFF Button Skin Adhesive Pull Liner 1 Ultrasound gel to be applied liberally on wide face of probe geometry Adhesive Pull Liner 2 Ultrasound Probe Face UNCONTROLLED UNLESS OTHERWISE SIGNED AND/OR STAMPED. -
Page 14: Basic Operation
User Manual – FloPatch FP120 Rev 2.0 For Use in the United States of America 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 connect to the mobile app. - Page 15 The text on the strap will be right-side up in this orientation. 7. Place the FloPatch FP120 lengthways across the neck, directly on top of the previously identified carotid artery. When the device is placed, the Doppler sound will begin to be heard from the mobile app.
- Page 16 Then hold the device in place and remove the end liners one at a time to adhere the entirety of the strap to the skin. 9. After securing the FloPatch FP120, 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.
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Page 17: User Interface
Low Battery If a FloPatch FP120 has been turned on but is not connected to the mobile application, or a connected FloPatch FP120 device has not been used to complete an assessment in the last 30 seconds, it will enter a standby mode in which the device is not streaming data to the mobile application. -
Page 18: Home Screen
In addition, the Welcome Screen displays the version of the application at the bottom of the screen. Home Screen The Home Screen is the main navigation menu for the FloPatch FP120 iOS application. It allows the user to access the core functionality of the FloPatch FP120 application through its three buttons:... -
Page 19: Flopatch Connection Screen
ID. This ID can be found on the top of the device as indicated in the image. The application will only allow for one FloPatch FP120 to be connected at a time. -
Page 20: Flopatch Info And Disconnect Screen
For Use in the United States of America FloPatch Info and Disconnect Screen The FloPatch Info screen appears when a FloPatch FP120 device is connected to the mobile medical application and the FloPatch Connection Info button, shown below, is pressed on the Assess Blood Flow Screen or the Home Screen. -
Page 21: Assess Blood Flow Screen
The Assess Blood Flow screen is where the Doppler information taken from the FloPatch FP120 is displayed graphically to the user. This screen is the core functional part of the FloPatch FP120 iOS application and has several features. In the above image, the parts of the screen are labeled 1-16, and information about... - Page 22 6. The covers the upper half of the screen and displays the maximum velocity trace, as measured by the FloPatch FP120, in real time. The waveform streams from the left side of the screen to the right with a scrolling axis.
- Page 23 User Manual – FloPatch FP120 Rev 2.0 For Use in the United States of America FloPatch Connection Information Wireless Connection Performance Indicator. 13. Next to the icon is a The warning icon flashes red when data has not been successfully transferred between the device and the mobile application to warn the user of a decrease in signal quality.
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Page 24: Saved Assessments Screen
A session may be deleted or loaded by the user. If deleted, the session be recovered. When a different FloPatch FP120 is connected to the iOS device to be used with a different patient, any assessments completed with the previous FloPatch device will no longer be accessible. - Page 25 User Manual – FloPatch FP120 Rev 2.0 For Use in the United States of America 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...
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Page 26: Peak Velocity Alert
WIRELESS CONNECTION PERFORMANCE An indicator, as shown below, is displayed on the Assess Blood Flow Screen to provide information on the quality of the wireless connection and data transfer between the FloPatch FP120 device and the Mobile Medical Application. The warning symbol remains grey in colour during normal use and flashes red when data is not transferred successfully. -
Page 27: Cyber-Security
Doppler shift data in real-time, in such a way that the data could interpreted by the FloPatch FP120 software, and if interpreted by the software, and 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. -
Page 28: Troubleshooting The Flopatch Fp120
Doppler-shift which is mechanical (rather than physiological) in nature. Protocol: 1) Ensure the FP120 is connected to the iOS device running FloPatch FP120 application. 2) Ensure the volume setting audible (i.e., not on mute). 3) Once the sensor has been acoustically coupled over the target vessel (or when the transducer is gel loaded) the user can tap-and-listen for a large amplitude mechanical Doppler shift. -
Page 29: Maintenance
Please follow the instructions to update the application. The firmware for the FloPatch FP120 hardware cannot be updated by the user. It can only be updated by Flosonics Medical or an authorised representative of Flosonics Medical. -
Page 30: Appendix A - Product Specifications
User Manual – FloPatch FP120 Rev 2.0 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 and IEC 60601-1-2. Battery Specifications Lithium Polymer, IEC 62133... -
Page 31: Appendix B - Compatible Mobile Devices & Wireless Information
Version: iOS 12+ Wireless Information The FloPatch FP120 uses Bluetooth Low Energy 5 (BLE 5 or BT5) for wireless data transmission to a compatible mobile device. The FloPatch FP120 will not connect to any device that does not have the FloPatch FP120 mobile medical application installed. -
Page 32: 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 33 User Manual – FloPatch FP120 Rev 2.0 For Use in the United States of America ±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...
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Page 34: Electromagnetic Environment - Guidance
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. -
Page 35: 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 36: Emc Note
14.5 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 37: Appendix D - Ultrasound Intensity And Safety
Ultrasound waves dissipate energy in the form of heat and can, therefore, cause tissue warming. Although this effect is extremely low with the FloPatch FP120, it is important to know how to control and limit patient exposure. Major governing bodies in ultrasound have issued statements to the effect that there are no known adverse effects from the use of diagnostic ultrasound, however, exposure levels should always be limited to ‘As Low As Reasonably Achievable’... -
Page 38: Measurement Uncertainties
User Manual – FloPatch FP120 Rev 2.0 For Use in the United States of America 3. TIC (Thermal Index for cranial applications): It provides an estimate of potential temperature rise in the cranial bones or superficial bones. 14.8.3 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 39: 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 40: Scanning Modes
User Manual – FloPatch FP120 Rev 2.0 For Use in the United States of America (cm) 2.50 (cm) 2.70 zpii, α (cm) 2.70 fawf (MHz) 4.03 4.03 4.03 4.03 (Hz) (Hz) npps Ipa, α at (W/c zpii,α Other Ispta,α at... - Page 41 User Manual – FloPatch FP120 Rev 2.0 For Use in the United States of America Output power Depth for bone thermal index Depth for soft-tissue thermal index Depth for mechanical index Pulse repetition rate Attenuated pulse-average intensity pa,α Spatial-peak temporal-average intensity spatial-peak temporal-average intensity...
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