Butterfly iQ User Manual
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Butterfly iQ User Manual

Personal ultrasound system
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Butterfly iQ™ Personal
Ultrasound System
User Manual

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  • Page 1 Butterfly iQ™ Personal Ultrasound System User Manual...
  • Page 2 2020-03-24 Revision: V Notice Butterfly Network, Inc. (BNI), shall not be liable for errors contained herein or for incremental or consequential damages in connection with the furnishing, performance, or use of this material. Proprietary Information This document contains proprietary information, which is protected by copyright.

  • Page 3: Table Of Contents

    Safety Conventions ........................ 7 Ultrasound Benefits and Risks ....................7 Ultrasound Benefits ......................7 Ultrasound Risks ......................7 Butterfly iQ™ Safety ....................... 8 Basic Safety/Usage Environment ....................8 Electrical Safety ........................10 Defibrillation Safety ......................11 Equipment Protection ......................11 Biological Safety ........................
  • Page 4 11. Troubleshooting ........................33 Troubleshooting ........................33 12. Getting Support ........................35 Contacting Butterfly Support ....................35 Contacting Support through the Butterfly iQ™ App ..............35 13. Specifications ........................36 Mobile Device Requirements ....................36 System Specifications ......................36 Probe Battery Charger ......................37 Environmental Operating Conditions ..................

  • Page 5: Introduction

    This chapter provides an introduction to the Butterfly iQ™ Personal Ultrasound System. Overview Butterfly iQ™ personal ultrasound is designed to be easy to use, portable, and battery powered. Its commercial off- the-shelf mobile platform (mobile device) provides a simple interface for the user.

  • Page 6: Contraindications For Use

    Contraindications for Use Butterfly iQ™ should not be used for indications other than the ones approved by the applicable governing agency. Training In order to safely and effectively operate Butterfly iQ™, the user shall meet the following: •...

  • Page 7: Safety Information

    This user manual is intended to assist in the safe and effective operation of Butterfly iQ™. It is important that all users review and understand all instructions in this user manual before operating the device, paying careful attention to the warnings and cautions throughout the manual.

  • Page 8: Butterfly Iq™ Safety

    • Movement of the patient during scanning may impact results. User should exercise clinical judgement in the interpretation of results. • Do not use Butterfly iQ™ until the materials present in this manual have been reviewed and fully understood. Do not operate Butterfly iQ™ for purposes other than intended in this manual.
  • Page 9 Contact Support at: support@butterflynetwork.com • Do not use Butterfly iQ™ in the presence of flammable gases or anesthetics. Doing so can re- sult in a possible fire or explosion. • Butterfly iQ™ has not been evaluated or approved for use in hazardous locations as defined in the National Electric Code standard.

  • Page 10: Electrical Safety

    • Portable RF communications equipment (including peripherals such as antenna cables and ex- ternal antennas) should be used no closer than 30 cm (12 inches) to any part of the Butterfly iQ™, including cables specified by the manufacturer. Otherwise, degradation of the perform- ance of this equipment could result.

  • Page 11: Defibrillation Safety

    Ultrasound Safety” publication. This publication is available as a PDF link in the Butterfly iQ™ App. • If Butterfly iQ™ is contaminated due to exposure to Creutzfeldt-Jakob disease, there is no ade- quate disinfecting procedure. • Use the correct clinical application presets for the associated body part being examined. Some applications require lower acoustic output limits.

  • Page 12: Operator Safety

    Doing so may result in injury to the patient or operator. • Do not use the Butterfly iQ™ Application on a mobile device that does not meet minimum re- quirements. Using the Butterfly iQ™ Application on a mobile device that does not meet the mini- mum requirements may affect performance and image quality, possibly resulting in misdiagno- sis.

  • Page 13: System Overview

    This chapter provides an overview of Butterfly iQ™. It includes information about its features, the components that are included in the system, requirements necessary to download, install, and use the Butterfly iQ™ App, and an overview of the user interface.

  • Page 14: Internet Connectivity

    The App is a free download from the Apple App Store or Google Play Store. The App and Butterfly account are re- quired to use the Butterfly iQ™ personal ultrasound.

  • Page 15: Probe

    Do not connect third-party probes to the Butterfly iQ™ mobile device and do not attempt to use the Butterfly iQ™ probe with other ultrasound systems. The Butterfly iQ™ probe is only for use with the Butterfly iQ™ App. Do not attempt to connect the probe to other ultrasound systems.

  • Page 16: Probe Battery Charger

    Figure 2. Charging Pad Components 1. Charging Pad 2. Charging Cable 3. Wall Adaptor NOTE The latest Butterfly iQ™ charger has a matte black finish. If you have a previous model please visit support.butterflynetwork.com for additional information on charging your probe. System Overview...

  • Page 17: Overview Of User Interface

    The app user interface will always show information about the Mechanical Index (MI) and the Thermal Index (TI) at the top of the screen. Depending on your Butterfly membership status and mobile app version, the toolbar at the bottom of the screen may vary.

  • Page 18: Setting Up The System

    Butterfly iQ™ App, and charging the probe for use. Downloading and Installing the App You can download and install the Butterfly iQ™ App by visiting the Apple App Store or Google Play Store on your mobile device. Once in the App Store, search for "Butterfly iQ".

  • Page 19: Charging The Probe

    Google Play Store. Charging the Probe WARNINGS! • Use only cables, probes, chargers and accessories specified for use with Butterfly iQ™. Substi- tution of non-approved accessories may cause the system to perform improperly or cause injury to the patient or operator.
  • Page 20 Charging the Probe NOTE The latest Butterfly iQ™ charger has a matte black finish. If you have a previous model please visit support.butterflynetwork.com for additional information on charging your probe. NOTE • Your exact charging pad may vary. • Butterfly iQ™ uses a wireless charging system. Do not attempt to insert your probe’s cable into the charging pad.

  • Page 21: Checking Probe Battery Level

    2. If the first button flashes, it indicates that the probe battery charge is too low to perform the study. To check the probe battery level using the Butterfly iQ™ App: • The probe battery status is displayed in the upper portion of the imaging screen.

  • Page 22: Using The System

    Using the System 5. Using the System This chapter provides information and instructions for using Butterfly iQ™ to begin and end studies. It also provides information and instructions for freezing and unfreezing during live imaging, for performing measurements, and other imaging tools.

  • Page 23: Uploading To Butterfly Cloud

    Uploading to Butterfly Cloud Uploading to Butterfly Cloud NOTE Depending on your platform, hardware, country and membership type, certain presets and fea- tures may not be available. To archive a study: 1. When you finish capturing ultrasound images, tap the Capture Reel in the upper right corner of the screen. The Study screen is displayed.

  • Page 24: Using Modes

    Using Modes 6. Using Modes This chapter provides information and instructions for using modes when performing an ultrasound study. NOTE Advanced imaging capabilities may vary depending on the selected preset and status of paid sub- scription. Please visit support.butterflynetwork.com for the latest details on which preset has ac- cess to which modes.

  • Page 25: Annotations

    Annotations 7. Annotations This chapter provides information and instructions for performing annotations on images in the Butterfly iQ™ App. Annotations can include linear measurements, ellipse measurements, and text annotations. Adding Annotations You can add annotations on any frozen image or images and clips in the capture reel.

  • Page 26: Ai-Assisted Tools (Supported Devices Only)

    The Auto Bladder Volume tool allows you to calculate bladder volume when capturing scans and visualize the blad- der in 3D. • The Butterfly iQ™ has the capability to acquire a 3D sweep while you hold the probe steady. A volume estimate is then calculated from this 3D sweep.

  • Page 27: Using Butterfly Cloud

    Butterfly Cloud is a web-based application that allows users to upload and review ultrasound exams from the Butter- fly iQ™ App. Users of the cloud can also document, bill and integrate Butterfly iQ™ into existing hospital systems PACS, VNA, EMR, and Modality Worklist. Butterfly Cloud also supports the acceptance of images from third-party ultrasound devices.

  • Page 28: Maintenance

    Maintenance 10. Maintenance This chapter provides information and instructions for storing, transporting, cleaning, and disinfecting the probe. Maintaining the Probe Storing and Transport: CAUTIONS! • Avoid storing the probe where the probe or its cable could be easily damaged. • Avoid transporting the probe unless it is well supported and secured. Secure the cable tightly to the probe when transporting it or carrying it.

  • Page 29: Cleaning And Disinfecting The Probe

    While the Cleaning and Disinfection guidance contained here has been validated for effectiveness, a list of cleaning and disinfection products that are compatible with the Butterfly iQ™ probe, but not tested for effectiveness by Butter- fly, can be found in the "Compatible Cleaning and Disinfection Products" article available at support.butterflynet-...

  • Page 30: Disinfecting The Probe

    Cleaning and Disinfecting the Probe Disinfecting the Probe WARNING! Always inspect the probe before and after cleaning, disinfection, or use. Check the lens face, ca- ble, housing, seams, and connector for signs of damage such as cracks, chips, abrasions, or leaks.
  • Page 31 Making sure your probe is compatible with HLD: 1. Tap to display the Settings screen. 2. Tap My iQ to display the My iQ screen. 3. Ensure that the High-Level Disinfection Supported line indicates Yes. 4. Proceed with HLD only if supported on your probe.

  • Page 32: Updating The Probe And App Software

    Perform the diagnostic test periodically. With normal use, monthly testing is best practice. The diagnostic test is only for the Butterfly iQ™ ultrasound probe. The App does not have the ability to assess the mobile device’s screen integrity.

  • Page 33: Troubleshooting

    Troubleshooting 11. Troubleshooting This chapter provides information and instructions for troubleshooting the system. WARNING! Do not use the probe if there is any sign of damage. Contact Support. See Getting Support [35] for more information. Troubleshooting CAUTION! Ignoring the App alerts and messages may result in the system becoming inoperable. Table 3, “Troubleshooting”...
  • Page 34 Hardware Recall alert appears instructions. This indicates that your mobile device no longer has a passcode. The Butterfly iQ™ App requires that the mo- Forced Log Out alert appears bile device to have a passcode for patient data security. Tap Settings to enable and configure the passcode for your mobile device.

  • Page 35: Getting Support

    Australia Contacting Support through the Butterfly iQ™ App You can contact Butterfly Support directly through the Butterfly iQ™ App and submit a request for help. To access support: 1. From the imaging screen, tap your user avatar (user uploaded photo or your initials) in the upper left corner.

  • Page 36: Specifications

    Using the Butterfly iQ™ App on a mobile device that does not meet the minimum requirements may affect performance and image quality, possibly resulting in misdiagnosis. Butterfly iQ™ works on many Apple and Android devices. For the latest list of compatible mobile devices please visit support.butterflynetwork.com.

  • Page 37: Probe Battery Charger

    Table 6, “Environmental Operating Conditions” [37] lists the environmental conditions for the Butterfly iQ™ probe only. For details on the mobile device on which you run the Butterfly iQ™ App, refer to the accompanying documen- tation for your mobile device.

  • Page 38: Electromagnetic Conformance (Emc)

    FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. 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 Butterfly iQ™...

  • Page 39: Separation Distances

    Trained professionals should perform diagnostic ultrasound procedures safely for the intended purpose. Butterfly iQ™ and its thermal (TI) and mechanical (MI) safety limits are set to industry standards, as a Track 3 device, and are displayed on the display screen. The TI is displayed as either soft tissue (TIS), bone (TIB) or cranial bone (TIC), and, only one of these indices is displayed at any given time, based on the clinical setting default of a selected exam.
  • Page 40 ALARA training is provided by the American Institute of Ultrasound in Medicine (AIUM) in a booklet, “Medical Ultra- sound Safety.” This booklet is provided as a PDF link in the Butterfly iQ™ App and the Butterfly Cloud web interface. It provides training and educational information on ultrasound bio effects and biophysics, prudent use and imple- menting ALARA.
  • Page 41 Acoustic Output Transducer: Butterfly iQ™ Ultrasound System transducer Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Application Mode of Operation General (Track 1 Only) Specific (Tracks 1 & 3) Power Color Doppler...

  • Page 42: Acoustic Output Limits

    The ultrasound system maintains acoustic outputs below the appropriate limits for each application listed below. Non ophthalmic applications: System Probe TI Type TI Value SPTA.3 PA.3 Butterfly iQ™ 44.9 mW/cm 0.289 0.49 54.6 W/cm Ophthalmic applications: System Probe TI Type TI Value SPTA.3...
  • Page 43 Acoustic Output Table 13. B-Mode Non-Scan Index Label Non- Scan ≤1 >1 Scan aprt aprt Maximum Index Value 0.485 0.02 Pr.3 (MPa) 0.718 (mW) 4.40 min of [W (mW) TA.3 (cm) (cm) (cm) 5.83 (cm) (MHz) 2.19 2.41 X (cm) Dim of A aprt Y (cm)
  • Page 44 Acoustic Output Table 14. B-Mode + Color Non-Scan Index Label Non- Scan ≤1 >1 Scan aprt aprt Maximum Index Value 0.485 0.13 0.29 Pr.3 (MPa) 0.718 (mW) 17.4 min of [W (mW) 0.74 TA.3 (cm) (cm) 2.76 (cm) 5.83 (cm) 1.84 (MHz) 2.19...
  • Page 45 Acoustic Output Table 15. B + M-mode Non-Scan Index Label Non- Scan ≤1 >1 Scan aprt aprt Maximum Index Value 0.485 0.013 0.012 Pr.3 (MPa) 0.718 (mW) 2.64 0.63 min of [W (mW) TA.3 (cm) (cm) (cm) 5.83 (cm) (MHz) 2.19 2.41 1.56...
  • Page 46 Acoustic Output Table 16. B-Mode + Power Non-Scan Index Label Non- Scan ≤1 >1 Scan aprt aprt Maximum Index Value 0.485 0.13 0.29 Pr.3 (MPa) 0.718 (mW) 17.4 min of [W (mW) 0.74 TA.3 (cm) (cm) 2.76 (cm) 5.83 (cm) 1.84 (MHz) 2.19...
  • Page 47 Acoustic Output Table 17. B-Mode + Ophthalmic Non-Scan Index Label Non- Scan ≤1 >1 Scan aprt aprt Maximum Index Value 0.162 0.0015 0.0021 Pr.3 (MPa) 0.354 (mW) 0.0657 0.0657 min of [W (mW) TA.3 (cm) (cm) (cm) 1.65 (cm) (MHz) 4.80 4.80 4.80...
  • Page 48 Acoustic Output Table 18. Color + Ophthalmic Scan Non-Scan Index Label Non- ≤1 >1 Scan aprt aprt Maximum Index Value 0.162 0.00145 0.0167 0.0477 0.0340 Pr.3 (MPa) 0.355 (mW) 0.0633 0.719 0.719 0.719 min of [W (mW) TA.3 (cm) (cm) (cm) 2.15 1.22...

  • Page 49: Measurement Accuracy

    Butterfly Network is deeply invested in the preservation of the natural environment. Equipment may contain materi- als that pose a risk to the environment if proper disposal procedures are not followed. Recycle the Butterfly iQ™ probe and accessories at the end of their useful life and in accordance with local, state, provincial, and/or national regulations.

  • Page 50: Symbols

    Symbols 14. Symbols This chapter lists and describes the symbols and icons that may be used on the Butterfly iQ™, its accessories, and packaging. Symbols Table 19, “Symbols” [50] lists and describes a set of symbols for medical electronic equipment that classify a con- nection or warn of potential hazards.
  • Page 51 Symbols Refer- Symbol Standard Title Description ence Model name Model name for the device. Indicates a medical device that has not been subjected to a steriliza- ISO 15223-1 5.2.7 Non-sterile tion process. Refer to instruction ISO 7010 M002 To signify that the instruction manual/booklet must be read manual/ booklet Operator’s manual;...

  • Page 52: Notes

    Notes 15. Notes Notes...

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