Butterfly Network Butterfly iQ User manual

Butterfly iQ™ Personal
Ultrasound System
User Manual

950-20002-00
2020-05-13
Revision: X
Notice
Butterfly Network, Inc. (BNI), shall not be liable for errors contained herein or for incremental or consequential dam-
ages in connection with the furnishing, performance, or use of this material.
Proprietary Information
This document contains proprietary information, which is protected by copyright.
Limited Warranty
The “Limited Warranty” shipped with BNI products serves as the sole and exclusive warranty provided by BNI with
respect to the products contained herein.
Copyright
Copyright © 2020 Butterfly Network, Inc. All Rights Reserved.
Trademark Acknowledgements
Product names mentioned in this manual may be trademarks of their respective owners.
iPhone, iPad, and Lightning are trademarks of Apple Inc., registered in the U.S. and other countries.
Android is a trademark of Google LLC.
Manufacturer
Butterfly Network, Inc. 530 Old Whitfield Street Guilford, CT 06437 USA
Telephone: [phone]
FAX: [phone]
General inquiries: [e-mail]
Support and service: suppor[email protected]
Website: www.butterflynetwork.com
US Patents
Listing of applicable U.S. Patents in compliance with 35 U.S.C. §287:
www.butterflynetwork.com/patents
Disclaimer
The information contained in this document is subject to change without notice. Some feature sets may not be avail-
able to certain user groups based on platform and local regulatory restrictions. Names and data used in examples
are fictitious unless otherwise noted.
To obtain a printed copy of this manual at no additional cost, contact Butterfly Support at
support.butterflynetwork.com.

Table of Contents
1. Introduction ............................................................................................................................. 5
Overview .............................................................................................................................. 5
Intended Uses ....................................................................................................................... 5
Indications for Use ................................................................................................................. 5
Contraindications for Use ........................................................................................................ 6
Training ................................................................................................................................ 6
2. Safety Information .................................................................................................................... 7
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 .................................................................................................................. 11
Operator Safety ................................................................................................................... 12
3. System Overview .................................................................................................................... 13
Overview ............................................................................................................................ 13
Modes ....................................................................................................................... 13
Measurements ............................................................................................................ 13
Probe Types ................................................................................................................ 13
Patient Data Protection ................................................................................................. 14
Internet Connectivity .................................................................................................... 14
System Components ............................................................................................................ 14
Butterfly iQ™ App ........................................................................................................ 15
Probe ........................................................................................................................ 16
Probe Battery Charger .................................................................................................. 17
Overview of User Interface .................................................................................................... 18
Presets .............................................................................................................................. 18
4. Setting Up the System ............................................................................................................ 19
Downloading and Installing the App ........................................................................................ 19
Updating Firmware ............................................................................................................... 19
Managing App Updates ........................................................................................................ 19
Charging the Probe .............................................................................................................. 20
Checking Probe Battery Level ........................................................................................ 22
5. Using the System ................................................................................................................... 23
Performing a Study .............................................................................................................. 23
Uploading to Butterfly Cloud .................................................................................................. 24
6. Using Modes .......................................................................................................................... 25
Using Color Doppler Mode or Power Doppler Mode ................................................................... 25
Using M-Mode ..................................................................................................................... 25
Using Spectral Pulsed-Wave Doppler Mode ............................................................................. 25
7. Annotations ........................................................................................................................... 28
Adding Annotations .............................................................................................................. 28
8. Manual Calculations Packages ................................................................................................. 29
Making a Calculation ............................................................................................................ 29
9. AI-Assisted Tools ................................................................................................................... 30
Automatically Estimating Ejection Fractions .............................................................................. 30
Automatically Estimating Bladder Volume ................................................................................. 30
Butterfly iQ Educational View Guidance ................................................................................... 30
10. Using Butterfly Cloud ............................................................................................................ 31
3

Overview ............................................................................................................................ 31
Accessing Butterfly Cloud ...................................................................................................... 31
11. Using Butterfly TeleGuidance ................................................................................................. 32
Overview ............................................................................................................................ 32
12. Maintenance ......................................................................................................................... 33
Maintaining the Probe ........................................................................................................... 33
Cleaning and Disinfecting the Probe ........................................................................................ 34
Cleaning the Probe ...................................................................................................... 34
Disinfecting the Probe ................................................................................................... 35
Updating the Probe and App Software ..................................................................................... 37
Performing the Probe Diagnostic Test ...................................................................................... 37
13. Troubleshooting .................................................................................................................... 38
Troubleshooting ................................................................................................................... 38
14. Getting Support .................................................................................................................... 40
Contacting Butterfly Support .................................................................................................. 40
Contacting Support through the Butterfly iQ™ App .................................................................... 40
15. Specifications ....................................................................................................................... 41
Mobile Device Requirements ................................................................................................. 41
System Specifications .......................................................................................................... 41
Probe Battery Charger .......................................................................................................... 42
Environmental Operating Conditions ....................................................................................... 42
Electromagnetic Conformance (EMC) ..................................................................................... 43
Separation Distances ................................................................................................... 44
Acoustic Output ................................................................................................................... 44
Acoustic Output Limits .................................................................................................. 47
Acoustic Output Tables ................................................................................................. 47
Measurement Accuracy ........................................................................................................ 55
Waste Electrical and Electronic Equipment ............................................................................... 55
Recycling and Disposal ......................................................................................................... 55
16. Symbols ............................................................................................................................... 56
Symbols ............................................................................................................................. 56
17. Notes ................................................................................................................................... 58
4

1. 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.
This manual is intended to provide information to guide trained operators in the safe and effective operation and
proper maintenance of Butterfly iQ™ personal ultrasound, and applicable accessories. It is important that you read
and understand all instructions in this manual before operating the system, and pay careful attention to the warnings
and cautions throughout the manual.
NOTE
Depending on your platform, hardware, country and membership type, certain presets, modes and
features may not be available.
Intended Uses
CAUTION!
Federal law restricts this device to sale by or on the order of a physician.
Butterfly iQ™ is a general-purpose diagnostic ultrasound imaging system for use by a qualified and trained health-
care professional enabling diagnostic imaging, measurement of anatomical structures and fluid, and other applicable
tools.
Indications for Use
NOTE
All presets and features may not be available. Please visit support.butterflynetwork.com for infor-
mation specific to your device and country.
Butterfly iQ™ 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:
• Peripheral Vessel (including carotid, deep vein thrombosis and arterial studies)
• Procedural Guidance
• Small Organs (including thyroid, scrotum and breast)
Introduction
Introduction 5

• Cardiac
• Abdominal
• Urology
• Fetal/Obstetric
• Gynecological
• Musculoskeletal (conventional)
• Musculoskeletal (superficial)
• Ophthalmic1
Modes of operation include:
• B-Mode
• B-Mode + M-Mode
• B-Mode + Color Doppler
• B-Mode + Power Doppler
• Spectral Pulsed-Wave Doppler2
Use Butterfly iQ™ in accordance with all safety procedures and operating instructions as outlined within this manual,
and only for the purposes for which the device was intended.
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:
• Training as required by local, state, provincial, and national regulations
• Additional training as required by the authorizing physician
• A thorough knowledge and understanding of the material presented in this manual
1Not available in all countries.
2Not available in all countries.
Contraindications for Use
6 Introduction

2. Safety Information
This chapter provides important safety information for using Butterfly iQ™ and includes a list of warning and caution
messages. This user manual is accessible from the Butterfly iQ™ App and through the website
support.butterflynetwork.com.
Safety Conventions
WARNING!
Conditions, hazards, or unsafe practices that may result in serious personal injury or death.
CAUTION:
Conditions, hazards, or unsafe practices that may result in minor personal injury, damage to the
device, or loss of data.
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. The following conventions are used throughout this manual to
highlight safety concerns:
Ultrasound Benefits and Risks
Ultrasound is widely used because it provides many clinical benefits to the patient and has an excellent safety re-
cord. Ultrasound imaging has been used for over twenty years and there have been no known long-term negative
side effects associated with this technology.
Ultrasound Benefits
• Multiple diagnostic uses
• Immediate results
• Cost-effectiveness
• Portability
• Safety record
Ultrasound Risks
Ultrasonic waves can heat the tissues slightly. It is normal that the probe may feel warm to the touch while charging.
If you remove the probe from the charging pad before or immediately after charging is complete, it is recommended
that you allow the probe to cool down before use. Since the system limits patient contact temperature and will not
scan at or above 43°C (109°F), allowing the probe to cool down before use will optimize scan time performance.
Safety Information
Safety Information 7

Butterfly iQ™ Safety
WARNINGS!
• The Butterfly iQ™ is intended for use by competent users capable of interpreting image quality,
diagnosis, and clinical utility of the system.
• 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.
• Do not operate Butterfly iQ™ improperly. Failure to do so may result in serious personal injury
or death.
Basic Safety/Usage Environment
WARNING!
Butterfly iQ™ is classified as MR UNsafe and may pose unacceptable risks to the patient, medical
staff, or other persons within the MR environment.
Butterfly iQ™ Safety
8 Safety Information

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 may cause
injury to the patient or operator.
• If the probe seems unusually hot, produces an odor or smoke, or leaks, stop use immediately.
Unplug the probe from the mobile device or disconnect it from the wireless charger (if applica-
ble). Contact Support at: suppor[email protected]
• 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. In compliance with IEC classification, the Butterfly iQ™ is
not to be used in the presence of flammable substances/air mixtures.
• 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.
• Spilling fluids into the system may damage it or present a fire or shock hazard. Do not allow
fluids to enter the device.
• Store only within the range of environmental conditions specified in the technical specifications.
• Dangerous high voltages and currents are present. There are no user-serviceable parts. Do not
open, remove covers, or attempt repair.
• Portable and mobile radio-frequency (RF) communications equipment can affect Medical Elec-
trical Equipment.
• Internet access is required to view the user manual and Butterfly support portal. If you intend to
use Butterfly iQ™ without an internet connection download the user manual locally by visiting
support.butterflynetwork.com.
• Use of damaged equipment or accessories may cause the device to perform improperly and/or
result in injury to the patient or operator. Refer servicing to qualified service personnel.
• No modification is allowed. Do not modify cables, probes, chargers, or accessories specified for
use with Butterfly iQ™. Modification to equipment may cause the system to perform improperly
or may cause injury to the patient or operator.
CAUTIONS!
• Cardiac rhythm disturbances during cardiac studies using gas ultrasound contrast agents have
been observed in the diagnostic range of Mechanical Index (MI) values. See the specific pack-
age insert for the contrast agent being used for further details.
• Butterfly Cloud enables remote viewing of ultrasound images on a variety of platforms and in
uncontrolled environments (e.g., ambient lighting). Clinician discretion on the appropriate use of
images must be applied.
• Only trained operators should use the instrument for needle placement.
Basic Safety/Usage Environment
Safety Information 9

Electrical Safety
WARNINGS!
• Before use, carefully inspect the probe. Always inspect the probe before and after cleaning, dis-
infection, or use. Check the lens face, cable, housing, seams, and connector for signs of dam-
age such as cracks, chips, abrasions, or leaks. To avoid the risk of electrical hazards, do not use
the probe if there is any sign of damage.
• Dropping the probe may cause damage. Always inspect the probe before and after cleaning,
disinfection, or use. Check the lens face, cable, housing, seams, and connector for signs of
damage such as cracks, chips, abrasions, or leaks. To avoid the risk of electrical hazards, do
not use the probe if there is any sign of damage.
• Comply with IEC 60601-1 when using additional equipment along with the ultrasound device.
• Use of accessories, probes, and cables other than those specified or provided by the manufac-
turer of this equipment could result in increased electromagnetic emissions or decreased elec-
tromagnetic immunity of this equipment and result in improper operation.
• Use of this equipment adjacent to or stacked with other equipment should be avoided because it
could result in improper operation. If such use is necessary, this equipment and the other equip-
ment should be observed to verify that they are operating normally.
• Electrical shock to the patient or operator may result if voltages exceeding IEC 60601-1 for pa-
tient-applied parts are exceeded.
• The probe is designed to remain sealed. Do not attempt to open the probe or tamper with the
device internals, including the battery. Doing so may cause injury to the patient or operator.
• Do not immerse probe beyond specified levels. Immersion beyond specified levels may result in
electrical shock.
WARNINGS!
• 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.
CAUTIONS!
• Notifications and alerts from other third-party applications running on the mobile device may in-
terfere with the study.
• The emissions characteristics of this equipment make it suitable for use in industrial areas and
hospitals (CISPR 11 Group 1 Class A). If this equipment is used in a residential environment
(for which CISPR 11 Class B is normally required), this equipment might not offer adequate pro-
tection to radio- frequency communication services. The user might need to take mitigation
measures, such as relocating or re-orientating the equipment.
Electrical Safety
10 Safety Information