Page 1 Butterfly iQ/ iQ+/ iQ+ Bladder/ iQ3 Personal Ultrasound System User Manual...
Page 2 Revision: BK 2024-05-02 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 6302 Zug Switzerland Emergo Australia Level 20, Tower II Darling Park 201 Sussex Street Sydney, NSW 2000 Australia Importers Butterfly Network Netherlands B.V. Edisonweg 17 4207 HE Gorinchem The Netherlands MedEnvoy Switzerland Gotthardstrasse 28 6302 Zug Switzerland US Patents Listing of applicable U.S. Patents in compliance with 35 U.S.C. §287: www.butterflynetwork.com/patents...
Page 4: Table Of Contents
2.2. Ultrasound Benefits and Risks ..................10 2.2.1. Ultrasound Benefits ..................... 10 2.2.2. Ultrasound Risks ....................10 2.3. Butterfly iQ/ iQ+/ iQ3 Safety ..................... 11 2.4. Basic Safety/Usage Environment ..................11 2.5. Electrical Safety ......................14 2.6. Defibrillation Safety ......................15 2.7.
Page 5 15.4. Performing the Probe Diagnostic Test ................81 15.5. Replacing the Butterfly iQ+/ iQ3 Cable ................82 15.6. Scheduled maintenance ....................85 15.7. Expected service life for Butterfly iQ+/ iQ3 ................ 85 16. Troubleshooting ........................87 16.1. Troubleshooting ......................87 16.2.
Page 6 18.8. Measurement Accuracy ....................130 18.9. Waste Electrical and Electronic Equipment ..............130 18.10. Recycling and Disposal ..................... 130 19. Symbols ..........................132 19.1. Symbols ........................132 20. Notes ..........................137...
Page 7: Introduction
This chapter provides an introduction to the Butterfly iQ/ iQ+/ iQ3 Personal Ultrasound System. 1.1. Overview Butterfly iQ/ iQ+/ iQ3 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 8: Indications For Use
Butterfly iQ/ iQ+/ iQ3 is indicated for use by trained healthcare professionals in environments where healthcare is provided to enable diagnostic ultrasound imaging and measurement of anatomical structures and fluids of adult and pediatric patients for the following clinical applications: •...
Page 9: Training
Training 1.5. Training In order to safely and effectively operate Butterfly iQ/ iQ+/ iQ3, the user shall meet the following: • Training as required by local, state, provincial, and national regulations • Additional training as required by the authorizing physician •...
Page 10: Safety Information
This user manual is intended to assist in the safe and effective operation of Butterfly iQ/ iQ+/ iQ3. 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 11: Butterfly Iq/ Iq+/ Iq3 Safety
• Do not use Butterfly iQ/ iQ+/ iQ3 until the materials present in this manual have been reviewed and fully understood. Do not operate Butterfly iQ/ iQ+/ iQ3 for purposes other than intended in this manual.
Page 12 • Do not use Butterfly iQ/ iQ+/ iQ3 in the presence of flammable gases or anesthetics. Doing so can result in a possible fire or explosion. • Butterfly iQ/ iQ+/ iQ3 has not been evaluated or approved for use in hazardous locations as defined in the National Electric Code standard.
Page 13 NOTES The Butterfly iQ/ iQ+/ iQ3 has been designed to ensure that acoustic limits are not exceeded in any imaging mode. The Butterfly iQ/ iQ+/ iQ3 has been designed and certified to comply with: •...
Page 14: Electrical Safety
Doing so may cause injury to the patient or operator. • The cable on the Butterfly iQ is not designed to be removed by the user. The cable on the Butterfly iQ+/ iQ3 is designed to be removed by the user, but the user should check that the cable is fully installed to ensure the probe is protected from the external environment.
Page 15: Defibrillation Safety
• To avoid the possibility of internal condensation and possible damage, do not store the device outside of the specified environmental operating conditions. • Improper maintenance may cause Butterfly iQ/ iQ+/ iQ3 not to function. Maintain the equipment only as described in the maintenance section.
Page 16: Biological Safety
"Ultrasound Safety" under Acoustic Output [97]. • If Butterfly iQ/ iQ+/ iQ3 is contaminated due to exposure to Creutzfeldt-Jakob disease, there is no adequate disinfecting procedure. • Use the correct clinical application presets for the associated body part being examined. Some applications require lower acoustic output limits.
Page 17: 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 requirements. Using the Butterfly iQ Application on a mobile device that does not meet the minimum requirements may affect performance and image quality, possibly resulting in misdiagnosis.
Page 18: System Overview
System Overview 3. System Overview This chapter provides an overview of Butterfly iQ/ iQ+/ iQ3. 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 19: Modes
Android personal electronic devices including phones and tablets (the mobile device) • The Butterfly iQ Application (App), downloaded and installed on the compatible mobile device • The Butterfly iQ/ iQ+/ iQ3 Probe that connects to the mobile device to generate and receive ultrasound signals NOTE The mobile device is not included with the Butterfly iQ/ iQ+/ iQ3 Ultrasound System;...
Page 20: Internet Connectivity
3.1.5. Internet Connectivity An Internet connection is required to download, install, or update the Butterfly iQ App from the Apple App Store or Google Play Store. An Internet connection is also required to log in and to archive studies to Butterfly Cloud.
Page 21: Butterfly Iq App
3.2.1. Butterfly iQ App The primary function of the Butterfly iQ App is general-purpose diagnostic imaging, for use by qualified and trained healthcare professionals to enable the visualization and measurement of anatomical structures within the human body.
Page 22: Probe
Do not connect third-party probes to the Butterfly iQ/ iQ+/ iQ3 mobile device and do not attempt to use the Butterfly iQ/ iQ+/ iQ3 probe with other ultrasound systems. The Butterfly iQ/ iQ+/ iQ3 probe is only for use with the Butterfly iQ App. Do not attempt to connect the probe to other ultrasound systems.
Page 23: Probe Battery Charger
Charging Cable Wall Adaptor Wall Adaptor NOTES • The latest Butterfly iQ/ iQ+/ iQ3 charger has a matte black finish and curved probe cradle. If you have a previous model please see Probe Battery Charger [93] for additional information on charging your probe.
Page 24: Overview Of User Interface
3.3. Overview of User Interface This section provides information about the imaging display presented in the Butterfly iQ App 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.
Page 25: Setting Up The System
Butterfly iQ App, and charging the probe for use. 4.1. 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 applicable app store, search for "Butterfly iQ".
Page 26: Managing App Updates
Doing so may cause injury to the patient or operator. • The cable on the Butterfly iQ is not designed to be removed by the user. The cable on the Butterfly iQ+/ iQ3 is designed to be removed by the user, but the user should check that the cable is fully installed to ensure the probe is protected from the external environment.
Page 27 Butterfly iQ3 probes connect the contact charging cable USB end to the wall adapter. Plug the wall adapter into a power outlet. For Butterfly iQ/ iQ+ the charger will light up to show that it is powered on. For Butterfly iQ3 there is no indication on the contact charging cable itself that it is connected to power, however the battery indicator lights should illuminate on the probe itself.
Page 28: Checking Probe Battery Level
Wait 10 seconds until the “Run troubleshooting” button appears. Follow the troubleshooting steps. 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. • If the battery charge is too low, you may not be able to perform a study until the battery is recharged. Keep the battery fully charged whenever possible.
Page 29: Using The System
Using the System 5. Using the System This chapter provides information and instructions for using Butterfly iQ/ iQ+/ iQ3 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 30: Uploading To Butterfly Cloud
The Butterfly iQ3 probe has three buttons: the center (middle) button, the up button and the down button. Pressing the center button will behave in the same way as the button press on the Butterfly iQ/ iQ+, i.e. it will either capture a still, start-stop recording, or unfreeze an image.
Page 31 Using the Probe Button Functionality Plug in the Butterfly iQ/ iQ+/ iQ3 probe and enter the Profile menu at the bottom right of the screen by clicking the initials, or your avatar. Select the item “Probe button actions”. The unfreeze functionality is enabled by default, to turn it off, toggle the option titled: "Enable button actions" to the left to deactivate it, or toggle back to the right to activate it again.
Page 32: Using Modes
• Butterfly iQ/ iQ+ or any ultrasound system used for rupture screening of silicone gel-filled breast implants is suitable for asymptomatic patients only. For symptomatic patients or patients with equivocal ultrasound results for rupture at any time postoperatively, an MRI is recommended.
Page 33: Using Spectral Pulsed-Wave Doppler Mode
Using Spectral Pulsed-Wave Doppler Mode • Adjust the Depth and Gain • Perform time, distance, and heart rate measurements on the display Accessing M-Mode Select your desired preset and identify the area you'd like to image. Note that imaging will begin on B-Mode. Select Actions on the bottom of the imaging screen.
Page 34 Using Spectral Pulsed-Wave Doppler Mode NOTE Flow in the direction of the arrow will always be depicted above the baseline. Flow against the direction of the arrow will always be depicted below the baseline. Tap “Start Spectrum” to start the spectral trace. If you do not see a trace, adjust the position of the sample volume.
Page 35: Using Biplane Imaging
Using Biplane Imaging (Butterfly iQ+/ iQ3 only) • Because the measurements on the Spectrum could be used for any of the peaks, the velocities are generic; v and v • Following the convention used in Cardiac Pulsed Wave Doppler, only the absolute value of the measured velocities is shown.
Page 36: Using Fetal Heart Sounds
Using Fetal Heart Sounds Biplane is available in the following Cardiac presets: Standard and Coherence. Compared to linear presets, the Biplane mode has the following differences: To adjust the position of the perpendicular plane, touch and drag the white dot around the apex of the longitudinal (bottom) plane.
Page 37: Using Iq Slice
Slice and iQ Fan availability may vary depending on probe generation, Butterfly membership status and geographic location. iQ Slice is a capture mode that performs single volumetric sweep acquiring multiple slices of the region of interest. When using iQ Slice mode, you can: •...
Page 38 Using iQ Fan Mode iQ Fan is a live imaging mode that performs continuous, bi-directional elevational sweeps in real time over the region of interest. The elevational angle of the sweep will oscillate between +/- 20°. When using iQ Fan mode, you can: •...
Page 39: 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. 7.1. Adding Annotations You can add annotations while scanning either from the actions menu or the frozen scan screen. After acquisition, you can add annotations to images and clips in the exam reel.
Page 40: Using Protocols
Using Protocols After capturing an image or cine click on the in the top right corner of the scan screen. Click on the image or clip that you wish to annotate. Click "Edit". Select "Label Capture". Click "Aa" and either click a pre-defined label or type your own. Move the label to the proper place on the image.
Page 41 Using Protocols NOTE All protocol views are optional. You may select any view, including views you have already acquired if you would like to capture multiple examples of that view. Editing the Protocol View Label Tap the view label to activate editing. A pencil will appear next to the label To move the view label, drag the label to the desired position while editing is active.
Page 42: Manual Calculations Packages
• Depending on your platform, hardware, country and membership type, certain presets, modes and features may not be available. • The Butterfly iQ/ iQ+/ iQ3 and its accessories may be used multiple times on multiple patients. 8.1. Obstetric Calculations Making an Obstetric Calculation From the scan screen, select either the OB 1/GYN preset or the OB 2/3 preset.
Page 43: Manually Calculate Volume
Manually Calculate Volume Patient-reported dates 13. In the amniotic fluid index package, the report contains: AFI: amniotic fluid index Measurement inputs Patient-reported dates 14. In the Crown Rump Length package, the report contains: Gestational age Measurement inputs Patient reported dates 15.
Page 44: Gastric Volume Calculation
Gastric Volume Calculation 11. A measurement may be deleted before confirming or unfreezing by selecting the “x” next to the measurement label or the trash can icon in the report. 12. You will exit the volume calculation package when you upload your study. To exit the calculation package before uploading a study, select the X on the bottom of your screen or select the Actions menu and exit by selecting the X underneath.
Page 45: Carotid Diameter Reduction Calculation
Carotid Diameter Reduction Calculation NOTE The gastric volume calculation uses the following two equations depending on the age: Table 7. Gastric Volume Equations Age range Equation >= 18 years gastric volume (mL) = 27 + 14 * (MAD * MCD * pi / 4) - 1.28 * Age (in years) 4-18 years gastric volume (mL) = -7.8 + 3.5 * (MAD * MCD * pi / 4) + 0.127 * Age (in months) 8.4.
Page 46: Manually Calculate Angles
Manually calculate angles 8.5. Manually calculate angles The manual angle calculation package (Alpha/Beta) can be used to calculate the acute angle between two lines (an angle that is less than 90 degrees). Manually calculate angles From the scan screen, select the Musculoskeletal preset. Select the Actions Button on the bottom right corner of the screen.
Page 47: Calculation Package References
Calculation Package References 8.6. Calculation Package References Gestational Age and Estimated Fetal Weight via Fetal Biometrics Hadlock FP, Deter RL, Harrist RB, Park SK. Estimating fetal age: computer-assisted analysis of multiple fetal growth parameters. Radiology. 1984 Aug;152(2):497-501. Hadlock FP, Harrist RB, Carpenter RJ, Deter RL, Park SK. Sonographic estimation of fetal weight. The value of femur length in addition to head and abdomen measurements.
Page 48: Using The Needle Viz (In-Plane) Tool
Using the Needle Viz (in-plane) Tool 9. Using the Needle Viz (in-plane) Tool WARNING! When used alone, the Needle Viz (in-plane) tool will NOT enhance the visualization of needles inserted out-of-plane. Needle Viz (in-plane) is a tool that overlays a B-mode image optimized for visualizing needles inserted at a 20-40 degree angle on top of regular B-mode.
Page 49 Using the Needle Viz (in-plane) Tool To simultaneously use Biplane Imaging, activate Biplane from the actions menu. The reference plane will display the region-of-interest within which an in-plane needle will be highlighted. Additionally, if the needle crosses the orthogonal plane indicator, the position of the needle in the out-of-plane view will be projected upon the orthogonal plane.
Page 50: Ai-Assisted Tools
Not for use in lung zones that contain a large pleural effusion. Not to be used with pediatric patient populations (people below 22 years of age). Compatibility Auto B-line Counter is supported on all Butterfly iQ/ iQ+ compatible iOS and Android devices on supported OS versions. Accessing Auto B-line Counter The Auto B-line Counter can be accessed in the Lung Preset while scanning in B-Mode.
Page 51 Butterfly Auto B-line Counter Select B-line Count from the Actions menu, under Tools. NOTE If this is your first time using the B-lines tool, a tooltip will display with instructions on how to use the tool. The Auto B-line counter can be turned off by tapping X at the bottom of the screen while the tool is active or tapping the X in the Actions menu.
Page 52 Butterfly Auto B-line Counter A static, 30-degree sector intercostal space indicator is shown at the bottom of the screen that highlights the area of the image where the B-line count will be measured. Image gain can be adjusted by swiping left and right on the image. Image depth can be adjusted by swiping up and down on the image.
Page 53 Butterfly Auto B-line Counter Select Count. A 6 second cine will be captured. A countdown timer will appear in the lower left hand side of the screen. Do not move the probe during the cine recording. After capturing the cine, the device will prepare the cine and indicate whether automated B-line count is successful.
Page 54 Butterfly Auto B-line Counter Please see the sections below for information on how to edit a B-line count, save the cine, or delete the cine. Auto B-line Counter unsuccessfully calculates B-line count The Auto B-line Counter has the capability of identifying cines that are not adequate for an automatic B-line calculation by the tool based on an internal quality check.
Page 55 Butterfly Auto B-line Counter To do any other action, including enter a manual B-line count, save the cine, or delete the cine, press the “Continue” button on the popup window. Editing the Automated B-line Count The automated B-line counts for a captured cine can be manually edited by following the steps below. Press the “Edit”...
Page 56 Butterfly Auto B-line Counter The Lung Protocol can be used with the Auto B-line Counter tool to help label the lung zones being scanned by the user. To turn on the Lung Protocol, click on “Lung Protocol” located above the blue “Count” button. Please refer to the “Using Protocols”...
Page 57 Ground Truth. Study 1 was a retrospective analysis of de-identified lung ultrasound cines collected during the standard usage of the Butterfly iQ and Butterfly iQ+ products, uploaded to the Butterfly Cloud. This data comes from the population of providers using Butterfly devices in concert with the Butterfly Cloud application in the real world.
Page 58: Automatically Estimating Ejection Fractions
Automatically Estimating Ejection Fractions Category # of subjects <25 kg/m 25-30 kg/m 30 kg/m or higher Ethnicity Hispanic or Latino NOT Hispanic or Latino Unknown / Not Reported Race American Indian/Alaska Native Black or African American White Unknown / Not Reported B-line Count Performance: In both studies the inter-rater correlation coefficient (ICC) was calculated between the Auto B-line Counter’s B-line count predictions and the ground truth.
Page 59 Automatically Estimating Ejection Fractions The Simpson's Ejection Fraction tool allows you to estimate left ventricular Ejection Fractions (EF) when capturing cardiac studies from an apical four chamber view of the heart. Butterfly iQ uses the Simpson’s Monoplane method to calculate the ejection fraction.
Page 60 Automatically Estimating Ejection Fractions If the automatic EF tool is able to calculate an Ejection Fraction, the Automatic Ejection Fraction result screen is displayed, and the calculated Ejection Fraction is marked as an Auto-calculated Simpson's measurement. You have the option to either save this automatic result, edit the result and recalculate, or delete the result and cine. If the tool is not able to calculate an Ejection Fraction or you choose to edit your result, you will be directed to the Edit screen.
Page 61: Automatically Estimating Bladder Volume
The Butterfly Auto Bladder Volume Tool is a software application package. It is designed to view, quantify and report results acquired on Butterfly Network ultrasound systems for noninvasive volume measurements of the bladder, to support physician diagnosis. Indicated for use in adult populations.
Page 62 Bladder preset in B-mode. The Butterfly iQ/ iQ+/ iQ3 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 63 Automatically Estimating Bladder Volume Select Calculate. A 3D sweep of the bladder area is automatically acquired. Do not move the probe during the sweep. After successfully capturing the bladder, a volume is displayed at the bottom of the screen. The cine above the volume result displays the images and estimated bladder used to calculate the volume.
Page 64 Automatically Estimating Bladder Volume The Auto Bladder Volume tool allows you to save the estimated volume result for review in the Butterfly iQ Mobile App and Butterfly Cloud. Select Save from the bottom of the Bladder Volume result screen. The captured cine loop with the bladder volume estimate and bladder out line is saved to the Capture Reel.
Page 65: Butterfly Iq Educational View Guidance
• The measurement accuracy specifications assume the tool is being used to scan a tissue‐equivalent phantom as instructed. • The volume range of the 3D Auto Bladder Volume Tool is 0-740ml. Although higher volumes may be estimated and displayed, Butterfly Network cannot guarantee the accuracy of measurements outside of this stated range.
Page 66 Butterfly iQ Educational View Guidance The Educational View Guidance tools can be accessed in the Cardiac or Lung Preset while scanning in B- Mode. Tap Actions located at the bottom right corner of the screen.You have the option to select the following tools from the Educational View Guidance section: •...
Page 67: Using Butterfly Cloud
Butterfly Cloud is a web-based application that allows users to upload and review ultrasound exams from the Butterfly iQ App. Users of the cloud can also document, bill and integrate Butterfly iQ/ iQ+/ iQ3 into existing hospital systems such as a PACS, VNA, EMR, or Modality Worklist. Butterfly Cloud also supports the acceptance of images from third-party ultrasound devices.
Page 68 Viewing and Managing Studies Navigate to the archive that contains the study you want to move. In the top right corner of the study, click the "More" drop-down menu to display the menu. Select "Delete study." The system prompts you to confirm the deletion. Click "Delete"...
Page 69: Using Butterfly Teleguidance
• Depending on your platform, hardware, country and membership type, certain presets, modes and features may not be available. • The Butterfly iQ/ iQ+/ iQ3 and its accessories may be used multiple times on multiple patients. 12.1. Overview A TeleGuidance call requires both a scanner and remote collaborator.
Page 70: Using Butterfly Iq+ Care
• Depending on your platform, hardware, country and membership type, certain presets, modes and features may not be available. • The Butterfly iQ/ iQ+/ iQ3 and its accessories may be used multiple times on multiple patients. Overview Butterfly iQ+ Care requires a compatible device and access to the Butterfly iQ+ Care suite of features.
Page 71 Using Butterfly iQ+ Care NOTE This tutorial is not a substitute for professional clinician training and experience and may not include all possible patient to patient variation. Clinicians are solely responsible for patient care and for exercising their independent clinical judgment at all times.
Page 72: Using Butterfly Iq+ Bladder System
The Butterfly iQ+ Bladder requires a compatible device and compatible software. It is recommended to always install the latest version of the app. The Butterfly iQ+ Bladder probe is a configuration of the Butterfly iQ+ hardware platform, and thus shares its mechanical and electrical specifications.
Page 73 Turn on the iPad. Select the Butterfly iQ app; if the Butterfly iQ+ Bladder probe is connected, the system will start loading. Once the system loads you will be presented with a quick tips card. On this screen you will be able to start scanning by tapping on “Start Scanning”...
Page 74: Available Settings
Auto-freeze: Enable/disable the auto-freeze functionality, if enabled, when the probe detects that it has not been scanning for >30 seconds (e.g. probe scanning in air), it freezes the screen to save the probe’s battery. Contact Support: Contact Butterfly Network’s support team. User manual: Access an e-copy of the user manual.
Page 75: Maintenance
Maintenance 15. Maintenance This chapter provides information and instructions for storing, transporting, cleaning, and disinfecting the probe. 15.1. Maintaining the Probe Receiving and Unboxing the Probe In the event the packaging of the device is damaged upon receipt of the system, inspect the components as listed for any visible damage.
Page 76: Cleaning And Disinfecting The Probe At The Point-Of-Use
Following these instructions will also help to avoid damaging the probe during cleaning and disinfection. After each exam, promptly clean and disinfect the Butterfly iQ/ iQ+/ iQ3 per the instructions below to prevent drying of soil and contaminants in and on the device.
Page 77: Cleaning The Probe
Cleaning and Disinfecting the Probe at the Point-of-Use 15.2.1. Cleaning the Probe CAUTIONS! • Prevent any fluid from entering electrical or metal portions of the cable’s connector during the cleaning and disinfecting process. Damage due to fluid in these areas may result. •...
Page 78 Cleaning and Disinfecting the Probe at the Point-of-Use ® It is recommended that you use Super Sani-Cloth Germicidal Disposable Wipes by PDI, Inc. or bleach (0.6% Sodium Hypochlorite) and clean with non-linting wipes. ® To disinfect the probe using the Intermediate-Level Disinfection (ILD) method with Super Sani-Cloth Germicidal Disposable Wipes by PDI, Inc.: ®...
Page 79 Ethicon US, LLC. Making sure your probe is compatible with HLD: Enter the Settings menu. Tap My iQ to display the My iQ screen. Ensure that the High-Level Disinfection Supported line indicates Yes. Proceed with HLD only if supported on your probe.
Page 80 Cleaning and Disinfecting the Probe at the Point-of-Use Maintenance...
Page 81: 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/ iQ+/ iQ3 ultrasound probe. The app does not have the ability to assess the mobile device’s screen integrity.
Page 82: Replacing The Butterfly Iq+/ Iq3 Cable
Butterfly iQ is not supported and may result to permanent damage to the device. The cable on the Butterfly iQ+ probe can be replaced in the case of damage or a mobile device with a different connector type needs to be used. The probe and cable compatibility is summarized in Table 11, “Probe and...
Page 83 Replacing the Butterfly iQ+ Cable Remove the existing cable from the Butterfly iQ+ probe. Wrap the probe cable around your wrist while holding the probe firmly in the other hand. Pull the two apart. Do not use tools to grab the strain relief or the cord, as doing so might damage the cable.
Page 84 Replacing the Butterfly iQ+/ iQ3 Cable Figure 6. Align the Butterfly iQ+ cable prior to installation Figure 7. Expected gap between the cable strain relief and probe body after installing the Butterfly iQ+ cable Replacing the Butterfly iQ3 Cable Remove the existing cable from the Butterfly iQ3 probe. Wrap the probe cable around your wrist while holding the probe firmly in the other hand.
Page 85: Scheduled Maintenance
15.7. Expected service life for Butterfly iQ+/ iQ3 The expected service life of the Butterfly iQ+/ iQ3 probe is 5 years. The service life of the Butterfly iQ+/ iQ3 ultrasound probe can vary depending on several factors including but not limited to the: usage patterns, usage under...
Page 86 User Manual. The expected service life of the Butterfly iQ+/ iQ3 cable/charger is 3 years. The service life of the Butterfly iQ+/ iQ3 cable/charger can vary depending on several factors including but not limited to the: usage patterns, usage under environmental conditions, and the user’s proper care and maintenance of the accessories.
Page 87: Troubleshooting
Troubleshooting 16. 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 [91] for more information. 16.1. Troubleshooting CAUTION! Ignoring the app alerts and messages may result in the system becoming inoperable. Table 13, “Troubleshooting”...
Page 88: Troubleshooting Overheating Issues With The Probe
You may need to charge the probe for at least six (6) hours. App Alerts and Messages This indicates that your mobile device does not have a passcode. Butterfly iQ requires the mobile device to App opens but cannot login: have a passcode for patient data security.
Page 89: Troubleshooting Charging Issues
Probe Temperature During Charging It is normal that the probe may feel warm to the touch while charging, especially on the Butterfly iQ/ iQ+, which uses wireless charging that is known to create heat during the charging process. On the Butterfly iQ/ iQ+, if you feel the probe is overheating during charging, review best practices for probe orientation based on the charger model, as positioning the probe on the charging pad incorrectly can increase the temperature of the probe while charging.
Page 90 If these instructions do not resolve your issue, please follow the in-app probe troubleshooting steps as follows: Log in to the Butterfly iQ app and navigate to the scan screen. Connect the probe and wait for at least 5 seconds.
Page 91: Getting Support
Getting Support 17. Getting Support This chapter lists contact information if you require support for the probe and Butterfly iQ/ iQ+/ iQ3 App. 17.1. Contacting Butterfly Support Butterfly Network, Inc. 1600 District Ave Burlington, MA 01803 USA Telephone: +1 (855) 296-6188 General inquiries: info@butterflynetwork.com...
Page 92: Specifications
Butterfly iQ+ Bladder only utilizes the Bladder preset, as such the depth is limited between 5 cm and 20 cm Butterfly iQ+ Bladder only utilizes the Bladder preset, as such the available frequency range is 1-5 MHz...
Page 93: Probe Battery Charger
Probe Battery Charger 18.3. Probe Battery Charger Table 15. Butterfly iQ/ iQ+ Battery Charger Specifications Probe Charging Pad Item Specification Wireless Charging Standard Qi Compliant Input Voltage DC 5V / 2A Input Interface Micro-USB Wireless Charging Power Wireless Charging Efficiency >...
Page 94: Environmental Operating Conditions
Table 17, “Environmental Operating Conditions” [94] lists the environmental conditions for the Butterfly iQ/ iQ+/ iQ3 probe only. For details on the mobile device on which you run the Butterfly iQ App, refer to the accompanying documentation for your mobile device.
Page 95: Electromagnetic Conformance (Emc)
Not applicable emissions EN/IEC 6100-3-3 The Butterfly iQ/ iQ+/ iQ3 Ultrasound System uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. The Butterfly iQ Ultrasound System is suitable for use in all establishments, excluding domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Page 96 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Butterfly iQ/ iQ+/ iQ3 Ultrasound System is used exceeds the applicable RF compliance level above, the Butterfly iQ/ iQ+/ iQ3 Ultrasound System should be observed to verify normal operation.
Page 97: Separation Distances
Trained professionals should perform diagnostic ultrasound procedures safely for the intended purpose. Butterfly iQ/ iQ+/ iQ3 Thermal Index (TI) and Mechanical Index (MI) acoustic safety limits are set to industry standards, and as a Track 3 device, are displayed on the display screen. The TI is displayed as either soft tissue (TIS) or bone (TIB), and only one of these indices is displayed at any given time, based on the clinical user setting of a selected exam.
Page 98 (listed in the tables below) by more than 0.2. Track 3 Specific Information The Butterfly iQ/ iQ+/ iQ3 adheres to conformance with FDA Track 3 output settings, output display and ALARA safety principles. In support of Track 3 acoustic output, the following tables provide the global maximum acoustic output indices for the probe and each of its clinical output modes.
Page 99 Acoustic Output Transducer: Butterfly iQ/ iQ+/ iQ3 Ultrasound System transducer Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Application Mode of Operation General Specific (Tracks Combined (Track 1 Power Color Doppler Slice 1 &...
Page 100: Acoustic Output Limits
Acoustic Output Transducer: Butterfly iQ/ iQ+/ iQ3 Ultrasound System transducer Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Application Mode of Operation General Specific (Tracks Combined (Track 1 Power Color Doppler Slice 1 &...
Page 101 Acoustic Output Butterfly iQ Acoustic tables Table 23. Butterfly iQ B-Mode Non-Scan Index Label Non- Scan ≤1 >1 aprt aprt Scan 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...
Page 102 Acoustic Output Table 24. Butterfly iQ 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...
Page 103 Acoustic Output Table 25. Butterfly iQ 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...
Page 104 Acoustic Output Table 26. Butterfly iQ 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...
Page 105 Acoustic Output Table 27. Butterfly iQ Pulsed Wave Doppler Index Label Below Below Surface Surface Surface Surface Maximum Index Value 0.21 .0915 0.14 0.10 Index Component Value 0.09 .0408 .0915 0.14 (MPa) 0.44 (mW) 4.67 4.67 4.67 (mW) 4.48 4.48 (cm) 2.87...
Page 106 Acoustic Output Butterfly iQ+ Acoustic tables Table 28. Butterfly iQ+ B-Mode, Biplane, 3D/Peak MI Index Label Below Below Surface Surface Surface Surface Maximum Index Value 0.43 0.00388 0.00388 0.0131 Index Component Value 0.00388 0.00388 0.00388 0.00388 (MPa) 0.76 (mW) 0.38 0.38...
Page 107 Acoustic Output Table 29. Butterfly iQ+ B-Mode, Biplane, 3D/Peak TIS,TIB Index Label Below Below Surface Surface Surface Surface Maximum Index Value 0.22 0.0153 0.0153 0.0521 Index Component Value 0.0153 0.0153 0.0153 0.0153 (MPa) 0.41 (mW) 1.53 1.53 1.53 (mW) 0.91 0.91...
Page 108 Acoustic Output Table 30. Butterfly iQ+ Color/Power + B-Mode/Peak MI,TIB Index Label Below Below Surface Surface Surface Surface Maximum Index Value 0.29 0.0479 0.17 0.24 1: 0.00453 1: 0.0453 0.00453 0.00453 Index Component Value 2: 0.0453 2: 0.0386 2: 0.0430 2: 0.16...
Page 109 Acoustic Output Table 31. Butterfly iQ+ Color/Power + B-Mode/Peak TIS Index Label Below Below Surface Surface Surface Surface Maximum Index Value 0.17 .0649 0.15 0.42 1: 0.00323 0.00323 0.00323 0.00323 Index Component Value 2: 0.0512 2: 0.0617 2: 0.0512 2: 0.15 (MPa) 2: 0.27...
Page 110 Acoustic Output Table 32. Butterfly iQ+ M-Mode + B-Mode/Peak MI Index Label Below Below Surface Surface Surface Surface Maximum Index Value 0.43 0.00283 0.00519 0.00953 1: 0.00246 1: 0.00246 1: 0.00246 0.00246 Index Component Value 2: 0.000369 0.000298 0.000369 0.00273 (MPa) 1: 0.76...
Page 111 Acoustic Output Table 33. Butterfly iQ+ M-Mode + B-Mode/Peak TIS,TIB Index Label Below Below Surface Surface Surface Surface Maximum Index Value 0.19 0.0107 0.0127 0.0732 1: 0.00952 0.00952 0.00952 0.00952 Index Component Value 2: 0.00113 2: 0.0318 0.00135 0.00135 (MPa) 1: 0.31...
Page 112 Acoustic Output Table 34. Butterfly iQ+ Pulsed Wave / Peak MI,TIS,TIB Index Label Below Below Surface Surface Surface Surface Maximum Index Value 0.34 1.31 0.88 Index Component Value 0.18 1.31 (MPa) 0.45 (mW) 76.47 76.47 76.47 (mW) 23.86 23.86 (cm) 10.20...
Page 113 Acoustic Output Butterfly iQ3 Acoustic tables Table 35. Butterfly iQ3 reportable mode 1 (Vascular: Deep Vein (B-Mode)) Index Label Below Below At Surface At Surface Surface Surface Maximum Index Value 0.51 1.84E-02 1.84E-02 2.92E-02 Index Component Value 1.84E-02 1.84E-02 1.84E-02 1.84E-02 (MPa) 1.18...
Page 114 Acoustic Output Table 36. Butterfly iQ3 B-Mode, reportable mode 2 (Vascular: Deep Vein (B+C)) Index Label Below Below At Surface At Surface Surface Surface Maximum Index Value 0.51 4.27E-02 5.99E-02 6.46E-02 1: 1.84E-02 1: 1.84E-02 1: 1.84E-02 1: 1.84E-02 Index Component Value 2: 2.46E-02 2: 2.38E-02 2: 2.46E-02...
Page 115 Acoustic Output Table 37. Butterfly iQ3 reportable mode 2 (Vascular: Deep Vein (B+C)), component 1 (5.5MHz-36.0mm-B- mode/M-mode) Index Label Below Below Surface Surface Surface Surface Maximum Index Value 0.51 1.84E-02 1.84E-02 2.92E-02 Index Component Value 1.84E-02 1.84E-02 1.84E-02 1.84E-02 (MPa) 1.18 (mW) 1.68...
Page 116 Acoustic Output Table 38. Butterfly iQ3 reportable mode 2 (Vascular: Deep Vein (B+C)), component 2 (5.0MHz-60.0mm-Color-mode) Index Label Below Below At Surface At Surface Surface Surface Maximum Index Value 0.22 2.46E-02 4.07E-02 3.54E-02 Index Component Value 2.46E-02 2.38E-02 2.46E-02 4.07E-02 (MPa) 0.50 (mW)
Page 117 Acoustic Output Table 39. Butterfly iQ3 reportable mode 3 (Vascular: Deep Vein (B+M)) Index Label Below Below At Surface At Surface Surface Surface Maximum Index Value 0.51 4.65E-02 0.16 7.16E-02 1: 1.84E-02 1: 1.84E-02 1: 1.84E-02 1: 1.84E-02 Index Component Value 2: 2.67E-02 2: 2.81E-02 2: 2.67E-02...
Page 118 Acoustic Output Table 40. Butterfly iQ3 reportable mode 3 (Vein Deep (B+M)), component 1 (5.5MHz-36.0mm-B-mode/M-mode) Index Label Below Below Surface Surface Surface Surface Maximum Index Value 0.51 1.84E-02 1.84E-02 2.92E-02 Index Component Value 1.84E-02 1.84E-02 1.84E-02 1.84E-02 (MPa) 1.18 (mW) 1.68 1.68 1.68...
Page 119 Acoustic Output Table 41. Butterfly iQ3 reportable mode 3 (Vascular: Deep Vein (B+M)), component 2 (5.5MHz-36.0mm-B-mode/M-mode) Index Label Below Below At Surface At Surface Surface Surface Maximum Index Value 0.51 2.81E-02 0.14 4.24E-02 Index Component Value 2.67E-02 2.81E-02 2.67E-02 0.14 (MPa) 1.18 (mW)
Page 120 Acoustic Output Table 42. Butterfly iQ3 reportable mode 4 (Abdomen Deep (B+M)) Index Label Below Below At Surface At Surface Surface Surface Maximum Index Value 0.16 3.23E-02 3.28E-02 5.76E-02 1: 3.01E-02 1: 3.01E-02 1: 3.01E-02 1: 3.01E-02 Index Component Value 2: 1.91E-03 2: 2.21E-03 2: 1.91E-03...
Page 121 Acoustic Output Table 43. Butterfly iQ3 reportable mode 4 (Abdomen Deep (B+M)), component 1 (3.0MHz-285.0mm-B-mode/M-mode) Index Label Below Below At Surface At Surface Surface Surface Maximum Index Value 0.16 3.01E-02 3.01E-02 5.42E-02 Index Component Value 3.01E-02 3.01E-02 3.01E-02 3.01E-02 (MPa) 0.28 (mW) 4.75...
Page 122 Acoustic Output Table 44. Butterfly iQ3 reportable mode 4 (Abdomen Deep (B+M)), component 2 (3.0MHz-285.0mm-B-mode/M-mode) Index Label Below Below Surface Surface Surface Surface Maximum Index Value 0.16 2.21E-03 2.74E-03 3.45E-03 Index Component Value 1.91E-03 2.21E-03 1.91E-03 2.74E-03 (MPa) 0.28 (mW) 0.30 0.30 0.30...
Page 123 Acoustic Output Table 45. Butterfly iQ3 reportable mode 5 (Cardiac Deep (PW)) Index Label Below Below Surface Surface Surface Surface Maximum Index Value 0.32 0.32 0.85 0.63 Index Component Value 0.21 0.32 0.21 0.85 (MPa) 0.44 (mW) 56.97 56.97 56.97 (mW) 24.30 24.30...
Page 124 Acoustic Output Acoustic Output Tables for Ophthalmic Applications Table 46. Butterfly iQ B-Mode + Ophthalmic Non-Scan Index Label Non- Scan ≤1 >1 aprt aprt Scan 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...
Page 125 Acoustic Output Table 47. Butterfly iQ Color + Ophthalmic Non-Scan Index Label Non- Scan ≤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...
Page 126 Acoustic Output Table 48. Butterfly iQ+ Ophthalmic B-Mode/Peak MI,TIS,TIB Index Label Below Below Surface Surface Surface Surface Maximum Index Value 0.0946 0.000779 0.000779 0.00134 Index Component Value 0.000779 0.000779 0.000779 0.000779 (MPa) 0.19 (mW) 0.0394 0.0394 0.0394 (mW) 0.0394 0.0394 (cm) 1.67...
Page 127 Acoustic Output Table 49. Butterfly iQ+ Ophthalmic Color/Power + B-Mode/Peak MI,TIS,TIB Index Label Below Below Surface Surface Surface Surface Maximum Index Value 0.10 0.00700 0.0150 0.0106 1: 0.000720 0.00720 0.000720 0.00720 Index Component Value 2: 0.00628 2: 0.00349 2: 0.0143 0.00628...
Page 128 Acoustic Output Table 50. Butterfly iQ3Ophthalmic B-Mode/Peak MI,TIS,TIB Index Label Below Below Surface Surface Surface Surface Maximum Index Value 0.10 4.37E-03 4.37E-03 7.16E-03 Index Component Value 4.37E-03 4.37E-03 4.37E-03 4.37E-03 (MPa) 0.27 (mW) 0.13 0.13 0.13 (mW) 0.13 0.13 (cm) (cm) (cm) 1.08...
Page 129 Acoustic Output Table 51. Butterfly iQ3 Ophthalmic Color/Power + B-Mode/Peak MI,TIS,TIB Index Label Below Below Surface Surface Surface Surface Maximum Index Value 0.14 1.18E-02 2.77E-02 2.93E-02 1: 4.21E-03 4.21E-03 4.21E-03 4.21E-03 Index Component Value 2: 7.63E-03 6.46E-03 7.63E-03 2.34E-03 (MPa) 2: 0.32 1: 0.12 1: 0.12...
Page 130: Essential Performance
Essential Performance 18.7. Essential Performance The Butterfly iQ/ iQ+/ iQ3 has been designed to ensure that acoustic limits are not exceeded in any imaging mode. The Butterfly iQ/ iQ+/ iQ3 has been designed and certified to comply with: • IEC 60601-1:2005+AMD1:2012+AMD2:2020 CSV Medical electrical equipment Part 1: General requirements for basic safety and essential performance.
Page 131 Recycling and Disposal Prior to recycling, items should be clean and contaminant free. Specifications...
Page 132: Symbols
Symbols 19. Symbols This chapter lists and describes the symbols and icons that may be used on the Butterfly iQ/ iQ+/ iQ3, its accessories, and packaging. 19.1. Symbols Table 52, “Symbols” [132] lists and describes a set of symbols for medical electronic equipment that classify a connection or warn of potential hazards.
Page 133 Ingress Protection rating system showing the degrees of protection from solid objects and Ingress IEC 60529 liquids. Butterfly iQ/ iQ+ is protected against the protection rating effects of immersion in water below the cable/ probe barrier, as indicated. IEC 60529...
Page 134 The backlight lamps in an LCD monitor contain mercury. The Butterfly iQ+ meets the requirements of the Regulation (EU) European European Union Medical Device Regulation (EU...
Page 135 Symbols Symbol Standard Reference Title Description Australian Sponsor: Emergo Australia Level 20, Tower II Darling Park 201 Sussex Street Sydney, NSW 2000 Australia MedEnvoy Switzerland Authorized Gotthardstrasse 28 ISO 15223-1 5.1.2 Swiss 6302 Zug Representative Switzerland Information to be Indicates that The Basic UDI-DI is the primary submitted upon EUMDR identifier of a device model.
Page 136 Symbols Symbol Standard Reference Title Description Indicates the entity importing the medical device 5.1.8 Importer 15223-1:2021 into the locale. Symbols...
Page 137: Notes
Notes 20. Notes Notes...

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