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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

Summary of Contents for Butterfly iQ

Page 1: ...Butterfly iQ Personal Ultrasound System User Manual ...

Page 2: ...ne 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 1 855 296 6188 FAX 1 203 458 2514 General inquiries info butterflynetwork com Support and service support butterflynetwork com Website www butterflynetwork com US Patents Listing ...

Page 3: ...s 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 M...

Page 4: ...ubleshooting 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 Measuremen...

Page 5: ...tures 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 f...

Page 6: ... 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 physi...

Page 7: ...lowing 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 Mu...

Page 8: ...ot 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 ...

Page 9: ...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 a...

Page 10: ...ent 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 b...

Page 11: ...ection Do not sterilize or autoclave the Butterfly iQ or its accessories Biological Safety WARNINGS Always use the ALARA As Low As Reasonably Achievable principle when performing an ultra sound study Additional information on the ALARA principle can be found in AIUM s Medical Ultrasound Safety publication This publication is available as a PDF link in the Butterfly iQ App If Butterfly iQ is contam...

Page 12: ...ip ment or accessories 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 CAUTIONS To minimize the risk of Carpel Tunn...

Page 13: ...ing phones and tablets the mobile device The Butterfly iQ Application App downloaded and installed on the compatible mobile device The Butterfly iQ Probe that connects to the mobile device to generate and receive ultrasound signals NOTE The mobile device is not included with the Butterfly iQ Ultrasound System you must purchase it separately Modes Butterfly iQ provides the following modes B Mode M ...

Page 14: ...lay Store An Internet connection is also required to log in and to archive studies to Butterfly Cloud Other wise no Internet connection or wireless connectivity is required to use the mobile device In order to ensure the app has the latest updates and safety information the app requires a connection to the inter net once every 30 days For additional information about internet connectivity requirem...

Page 15: ...f your mobile device does not meet the requirements necessary to download install or run the Butterfly iQ App the mobile device displays a notification Information Security Follow all security and cybersecurity policies of your institution If you do not know what these policies are contact your information technology IT department To use the Butterfly iQ App it is required that you set a password ...

Page 16: ... use with the Butterfly iQ App Do not attempt to connect the probe to other ultrasound systems Figure 1 Probe Components 16 shows the parts of the probe and describes its parts Figure 1 Probe Components 1 Lens 2 Midline Mark 3 Orientation Mark 4 Battery Indicator Lights 5 Battery Indicator Button 6 Probe Cable Boundary 7 Mobile Device Cable 8 Charging Source System Components 16 System Overview ...

Page 17: ... charging accessories 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 Components System Overview 17 ...

Page 18: ...creen may vary The toolbar at the bottom of the screen can be used for preset selection image freeze image capture and mode tool selection Presets Presets are a predefined set of imaging parameter values When selected the Butterfly iQ App automatically op erates in accordance with the corresponding set of imaging parameter values Presets available correspond to the clinical applications details in...

Page 19: ...in app updates may require a firm ware upgrade of your Butterfly iQ Firmware updates will be triggered on the first connection of the Butterfly iQ probe following an app update Managing App Updates CAUTIONS Butterfly supports the current and two previous releases of the App Upgrading across multiple versions of the App may require you to uninstall and reinstall the App resulting in possible data l...

Page 20: ...e battery is not user replaceable Replacement of the battery by parties other than But terfly Support may result in a hazard such as higher temperatures fire or explosion A non medical grade power supply must be used outside of the patient environment so that it is at least 1 5 meters from the patient CAUTIONS The probe battery should be charged at least monthly to ensure proper functionality If t...

Page 21: ...to show that it is powered on 4 Place the probe onto the charging pad so that the probe lies flat and wait for the probe s battery indicator lights to turn on When the probe battery is charging the probe battery indicator lights indicate the current battery level When the probe completes its charge the probe s battery indicator lights turn off For additional information on the status lights on you...

Page 22: ...k the probe battery level using the probe 1 Press the Battery Indicator Button to view the Battery Indicator Lights 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 If the battery charge is too low you m...

Page 23: ...ner of the screen with a number in it before the study is completed To conclude a patient encounter enter the capture reel and upload the study During scanning you may swipe horizontally to adjust the gain and swipe vertically to adjust the depth The Time Gain Compensation TGC control button is surfaced upon tapping the screen NOTE You can use the pinch and double tap gestures to zoom in on an ima...

Page 24: ...ure Reel in the upper right corner of the screen The Study screen is displayed 2 OPTIONAL Associate patient information 3 Tap Save to initiate an upload 4 Select an archive and press Upload 5 To delete all of the items from the Capture Reel tap Clear images The system prompts you to confirm the dele tion Clearing the series removes all of the images and clips from the Capture Reel Uploading to But...

Page 25: ...nd depth controls are available during Doppler imaging Using M Mode M Mode display includes speed controls Fast or Slow the M Mode line B Mode image and a move point to move the M Mode line When using M Mode you can Adjust the radial scan line by tapping and dragging the move point Adjust the sweep speed of the M Mode display by touching the Fast Slow control in the middle of the screen Adjust the...

Page 26: ...pri ately aligned flow in the Carotid Artery left and Internal Jugular Vein right is given below CAUTION Flow directionality is represented relative to the direction of the arrow Misalignment of the ar row may lead to misinterpretation of flow direction Carefully check that the arrow is aligned with the expected blood flow direction NOTE Flow in the direction of the arrow will always be depicted a...

Page 27: ...stance from the baseline first caliper dot and End Diastolic Velocity EDV the absolute value of the vertical distance from the baseline of the second caliper dot 10 The difference in time between the left and right ends of the caliper will be represented as time t in seconds 11 To save a Pulsed Doppler image freeze then press the capture button Using Spectral Pulsed Wave Doppler Mode Using Modes 2...

Page 28: ...ear measurements ellipse measurements and text annotations Adding Annotations You can add annotations on any frozen image or images and clips in the capture reel To add annotations during live imaging you must tap to first freeze the image to display the annotation tools The annotation tools are displayed below the image area Annotations 28 Annotations ...

Page 29: ...1 Gestational Age and Estimated Fetal Weight via Fetal Biometrics a Hadlock Frank P et al Estimating fetal age computer assisted analysis of multiple fetal growth parame ters Radiology 152 2 1984 497 501 b Hadlock F P et al Sonographic estimation of fetal weight The value of femur length in addition to head and abdomen measurements Radiology 150 2 1984 535 540 c Anderson N G I J Jolley and J E Wel...

Page 30: ...om Butterfly iQ Educational View Guidance The Educational View Guidance tools provide users with a visual indication of the quality of the image while scan ning with the Butterfly iQ The Educational View Guidance tools support the following views Cardiac Apical 4 Cham ber Parasternal Long Axis and Parasternal Short Axis and Lung A Lines B Lines view As you scan the subject the tool provides real t...

Page 31: ... 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 A Butterfly Cloud Administrator configures the archives adds new members and sets user access levels Adminis trators can also configure external connections to Butterfly Cloud For additional information on Butterfly Cloud please ...

Page 32: ...ept calls Network conditions can degrade the quality of image and video for remote collaborators To make a call as local scanner on iPhone or iPad On iOS click the Actions button on the bottom right of the main scanning screen and then the phone icon on the TeleGuidance row in the bottom right Select an online connection to call To receive a call as remote collaborator on a computer running Google...

Page 33: ...d in clean dry and moderate temperature conditions Follow these steps for daily storage and transport When storing the probe wrap the cable around the probe so that there is some slack at the bottom of the probe See Figure 4 Wrapping the Cable 33 for reference Avoid placing or storing in areas of excessive hot or cold temperatures or direct sunlight Avoid placing or storing with other equipment or...

Page 34: ...event 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 Prevent any fluid from splashing on your mobile device s touchscreen during scanning and dur ing cleaning Damage due to fluid may result To clean the probe 1 After each use of the probe use one of the recommended liquid satur...

Page 35: ... linting wipes To disinfect the probe using the Intermediate Level Disinfection ILD method with Super Sani Cloth Germi cidal Disposable Wipes by PDI Inc 1 Wipe the probe cable strain relief and connector with a Super Sani Cloth Germicidal Disposable Wipe Use additional fresh wipes as needed 2 Make sure the treated surface remains visibly wet for a minimum of two 2 minutes paying attention to seams...

Page 36: ...hed line shown in Figure 5 Probe Immersion Line 36 3 Immerse the probe in Cidex OPA solution up to the immersion line and ensure no air or bubbles are trapped Allow soaking according to the manufacturer s instructions 4 Thoroughly rinse the probe up to the immersion line by immersing it in a large volume of room temperature critical purified water for a minimum of one 1 minute Remove the probe and...

Page 37: ...sting 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 The diagnostic test runs through a series of diagnostic tests and notifies you when all tests have been successfully completed To perform the probe diagnostic test 1 Make sure the probe is connected to a supported mobile device wi...

Page 38: ...als a patient health problem rather than a mobile device problem To report a complaint or incident contact the FDA Problem Reporting Program MedWatch at 1 800 332 1088 or on the Internet www fda gov Safety MedWatch Table 3 Troubleshooting Issue Resolution App will not start Unplug the probe delete and reinstall the App App crashes Close the App and restart the App Check for software updates in the...

Page 39: ...Login Error Make sure your mobile device has network connectivity WiFi or a cellular connection Try to re enter your credentials Reset your password using a desktop computer browser to access Butterfly Cloud cloud butterflynetwork com If the steps above are not successful it may indicate that Butterfly Cloud service is undergoing maintenance or is unavailable Try again later Hardware Recall alert ...

Page 40: ...0 2514 AP The Hague The Netherlands Australian Sponsor Emergo Australia Level 20 Tower II Darling Park 201 Sussex Street Sydney NSW 2000 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 i...

Page 41: ...e devices please visit support butterflynetwork com NOTE The Butterfly iQ App does not affect the mobile device s operating system settings System Specifications Table 4 System Specifications Item Specifications Probe dimensions 185 x 56 x 35 mm 7 2 x 2 2 x 1 4 in Probe weight 313 grams 69 lbs Power Battery rechargeable Battery Life 2 hours in B Mode typical new battery at 25 C 2 hours refers to c...

Page 42: ...ting Conditions Table 6 Environmental Operating Conditions 42 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 Table 6 Environmental Operating Conditions Item Operating Limits Humidity Between 18 93 non condensing Altitude Between 150 ft below sea...

Page 43: ...s EN IEC 61000 4 4 Not applicable This device does not function on AC power Not applicable Mains power quality should be that of a typical commercial or hospital environment Power frequency 50 60 Hz mag netic field IEC 61000 4 8 30 A m 50Hz or 60Hz 3 orthogonal ori entations 30 A m 50 and 60Hz Power frequency magnetic fields should be at levels characteristic of a typical location in a typical com...

Page 44: ...d people Acoustic Output Ultrasound Safety 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 indi...

Page 45: ...n the tables below by more than 0 2 Track 3 Specific Information The Butterfly iQ adheres to conformance with FDA Track 3 output settings output display and ALARA safety prin ciples 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 Table 10 Probe Mode Combination Summary System Butterfly...

Page 46: ...Mode B Mode Color Doppler B Mode Power Doppler Other Gynecological X X X X B Mode M Mode B Mode Color Doppler B Mode Power Doppler Other Urology X X X X B Mode M Mode B Mode Color Doppler B Mode Power Doppler Cardiac Cardiac Adult X X X B Mode M Mode B Mode Color Doppler Cardiac Pediatric X X X B Mode M Mode B Mode Color Doppler Intravascular Cardiac Trans esoph Cardiac Intra cardiac Peripheral Ve...

Page 47: ...distance corresponding to the maximum of the derated spatial peak pulse intensity integral megapascals deq z The equivalent beam diameter as a function of axial distance z It is equal to 4 π Wo ITA z 0 5 where ITA z is the temporal average intensity as a function of z centimeters fc The center frequency MHz For MI fc is the center frequency associated with the transmit pattern giving rise to the g...

Page 48: ...Lx cm 10 0 FLy cm INF IPA 3 MImax W cm2 54 6 Operating Con trol Conditions FAST preset Abdomen deep Note 1 Information need not be provided for any formulation of TIS not yielding the maximum value of TIS for that mode Note 2 Information need not be provided regarding TIC for any TRANSDUCER ASSEMBLY not intended for transcranial or neonatal cephalic uses Note 3 Information on MI and TI need not be...

Page 49: ...IImax cm 1 84 Focal Length FLx cm 10 0 FLy cm 10 0 IPA 3 MImax W cm2 54 6 Operating Con trol Conditions FAST preset Bladder Note 1 Information need not be provided for any formulation of TIS not yielding the maximum value of TIS for that mode Note 2 Information need not be provided regarding TIC for any TRANSDUCER ASSEMBLY not intended for transcranial or neonatal cephalic uses Note 3 Information ...

Page 50: ...ocal Length FLx cm 10 0 FLy cm INF IPA 3 MImax W cm2 54 6 Operating Con trol Conditions FAST preset Abdomen Deep Cardiac THI Note 1 Information need not be provided for any formulation of TIS not yielding the maximum value of TIS for that mode Note 2 Information need not be provided regarding TIC for any TRANSDUCER ASSEMBLY not intended for transcranial or neonatal cephalic uses Note 3 Information...

Page 51: ...IImax cm 1 84 Focal Length FLx cm 10 0 FLy cm 10 0 IPA 3 MImax W cm2 54 6 Operating Con trol Conditions FAST preset Bladder Note 1 Information need not be provided for any formulation of TIS not yielding the maximum value of TIS for that mode Note 2 Information need not be provided regarding TIC for any TRANSDUCER ASSEMBLY not intended for transcranial or neonatal cephalic uses Note 3 Information ...

Page 52: ...Hz 3000 pr PIImax MPa 0 466 deq PIImax cm Focal Length FLx cm 2 2 FLy cm 2 2 IPA 3 MImax W cm2 6 24 Operating Con trol Conditions Ophthalmic Note 1 Information need not be provided for any formulation of TIS not yielding the maximum value of TIS for that mode Note 2 Information need not be provided regarding TIC for any TRANSDUCER ASSEMBLY not intended for transcranial or neonatal cephalic uses No...

Page 53: ...on PD μsec 0 175 PRF Hz 1100 pr PIImax MPa 0 507 deq PIImax cm 0 311 Focal Length FLx cm 4 0 5 0 FLy cm 4 0 lnf IPA 3 MImax W cm2 6 48 Operating Con trol Conditions Ophthalmic Note 1 Information need not be provided for any formulation of TIS not yielding the maximum value of TIS for that mode Note 2 Information need not be provided regarding TIC for any TRANSDUCER ASSEMBLY not intended for transc...

Page 54: ...ion per index Note 2 Data should be entered for at surface and below surface both in the columns related to TIS and TIB Note 3 Information on MI and TI need not be provided regarded using TIC for an TRANSDUCER ASSEMBLY not intended for transcranial or neonatal cephalic uses Note 4 If the requirements of 201 12 4 2a are met it is not required to enter any data in the columns related to TIS TIB or T...

Page 55: ...ed out wheeled bin symbol on this device indicates that this equipment has been put on the market after 13 August 2005 and is included in the scope of the directive 2002 96 EEC on Waste Electrical and Electronic Equip ment WEEE and of the national decree s which transpose provisions of such directive At the end of its lifetime this device cannot be disposed of as unsorted municipal waste and must ...

Page 56: ...d or opened ISO 15223 1 5 1 3 Date of Manufacture Indicates the date when the medical device was manufactured ISO 15223 1 5 3 1 Fragile handle with care Indicates a medical device that can be broken or damaged if not han dled carefully Global Medical De vice Nomenclature Code A system of internationally agreed generic descriptors used to identi fy all medical device products Globa Trade Item Numbe...

Page 57: ...medical device can be identified ISO 15223 1 5 3 2 Keep away from sunlight Indicates a medical device that needs protection from light sources WEEE Direc tive 20120 19 EU Waste Electrical and Electronic Equip ment Requires a separate collection for electrical and electronic equipment in compliance with the Waste Electrical and Electronic Equipment WEEE Directive When accompanied by Pb or Hg compon...

Page 58: ...17 Notes Notes 58 Notes ...

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