Hologic Viera Portable User Manual
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Hologic Viera Portable User Manual

Hologic Viera Portable User Manual

Breast ultrasound
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Summary of Contents for Hologic Viera Portable

  • Page 1 Viera Portable ™ Breast Ultrasound User Manual...
  • Page 2 Disclaimer: This disclaimer extends to all printed matter accompanying the Viera™ Portable Breast Ultrasound. This manual is licensed under the Terms and Conditions available at www.clarius.com/terms- conditions. You may not use this manual except in compliance with the license. The information contained in these materials is proprietary and confidential to Clarius Mobile Health Corp.
  • Page 3 Hologic Technical Support USA Support Center: (877) 371-4372 +1 (781) 999 7750 BreastHealth.Support@hologic.com European Support Center: +32 2 711 45 45 BE-Techsupport@hologic.com Australia Support Center: 1800 264 073 +61 2 9888 8000...

  • Page 4: Table Of Contents

    Table of Contents About This Manual ......................1 Target Audience........................1 Document Conventions .....................2 Touch Gestures........................2 Icons ............................3 Symbols Glossary........................3 Chapter 1: About the Viera™ Portable Breast Ultrasound ......9 Scanner Description ....................10 Scanner Dimensions....................12 Product Usage......................13 Indications for Use ......................13 Contraindications ......................
  • Page 5 Viera™ Portable Breast Ultrasound Scanners Page.........................31 Workflows Page......................32 Patient Demographics....................33 Indications Page ......................33 Imaging Page........................34 Review Page ........................35 Impressions Page ......................35 System Capabilities....................36 Error Messages........................36 Sleep Mode........................37 Auto Shutdown .......................37 Scanner Locator......................38 Need Help?.........................38 Additional Training ......................38 Need More Help?......................38 Chapter 3: Using the Viera™...
  • Page 6 Viera™ Portable Breast Ultrasound Resuming a Paused Exam.....................46 Managing Patient Information................46 Entering Patient Information..................46 Populating Indications ....................47 Selecting Scanning Modes..................47 B-Mode ..........................47 Color Doppler........................48 Power Doppler........................51 M-Mode ..........................51 Imaging ........................52 Adjusting Gain.........................53 Using the Center Line....................55 Using Needle Enhance ....................56 Using Automated Heart Rate..................57 Freezing/Unfreezing Cineloops..................58 Capturing Cineloops &...
  • Page 7 Viera™ Portable Breast Ultrasound Clarius Fan........................80 Chapter 5: Cleaning & Disinfecting ............81 Cleaning ........................82 Cleaning the Viera™ Portable Breast Ultrasound...........82 Cleaning the Clarius Dock....................83 Cleaning the Clarius Fan....................83 Disinfecting........................84 Disinfecting the Viera™ Portable Breast Ultrasound ..........84 Disinfecting the Clarius Fan ..................86 Spaulding Classification ..................86 Chapter 6: Safety ..................87 About Diagnostic Ultrasounds................87...
  • Page 8 Viera™ Portable Breast Ultrasound Chemical...........................115 Electrical Safety......................115 Federal..........................116 Labeling..........................116 Quality ..........................116 Security & Privacy......................118 Wireless..........................118 Doppler Sensitivity ....................119 Viera™ Scanner ......................119 Acoustic Output Tables ..................120 Viera™ Scanner: B-Mode & M-Mode .................120 Viera™ Scanner: Color Doppler Mode ..............121 Viera™ Scanner: Needle Enhance Mode ..............122 Control Effects Guidance Documents..............123 Cleaners &...

  • Page 9: About This Manual

    About This Manual To obtain a printed copy of this manual at no additional cost, please contact Hologic Technical Support. This document is licensed as part of the purchase of the Viera™ Portable Breast Ultrasound and meets applicable regulatory requirements. Use of this document by unauthorized persons is strictly prohibited.

  • Page 10: Document Conventions

    Viera™ Portable Breast Ultrasound Document Conventions Touch Gestures Gesture Title of Description gesture Drag Touch the screen with a finger and move the finger across the screen without lifting the finger. Double tap Touch the screen briefly twice with the same finger. Pinch Touch the screen with two fingers and move them toward each other.

  • Page 11: Icons

    Viera™ Portable Breast Ultrasound Icons Icon Title of Icon Description Alert Possible risks beyond the reasonable control of Clarius. Do not do this This icon indicates actions to avoid. Note This icon indicates informative material or helpful suggestions. Symbols Glossary The symbols shown in this document and on the Viera™...
  • Page 12 Viera™ Portable Breast Ultrasound : ISO 7000 — G — R TANDARD RAPHICAL SYMBOLS FOR USE ON EQUIPMENT EGISTERED SYMBOLS 2499 Sterile Indicates a medical device that has been subjected to a sterilization process. 2500 Sterilized using aseptic Indicates a medical device that has been processing techniques manufactured using accepted aseptic techniques.
  • Page 13 Viera™ Portable Breast Ultrasound : ISO 7000 — G — R TANDARD RAPHICAL SYMBOLS FOR USE ON EQUIPMENT EGISTERED SYMBOLS 0533 Upper limit of temperature Indicates the upper limit of temperature to which the medical device can be safely exposed. 0632 Temperature limit Indicates the temperature limits to which the medical...
  • Page 14 Viera™ Portable Breast Ultrasound : ISO 7000 — G — R TANDARD RAPHICAL SYMBOLS FOR USE ON EQUIPMENT EGISTERED SYMBOLS 2722 Fluid path Indicates the presence of a fluid path. 2724 Non-pyrogenic Indicates a medical device that is non-pyrogenic. 2726 Drops per milliliter Indicates the number of drops per milliliter.
  • Page 15 Viera™ Portable Breast Ultrasound You may see some of these standard symbols on your Viera™ Portable Breast Ultrasound, accessories, and packaging: — G — R THER STANDARDS RAPHICAL SYMBOLS FOR USE ON EQUIPMENT EGISTERED SYMBOLS Symbol Standard Reference Title Description ISO 7010 M002 Refer to instruction...
  • Page 16 Viera™ Portable Breast Ultrasound THER GRAPHICAL SYMBOLS FOR USE ON EQUIPMENT Waste Electrical and Requires separate collection for electrical and electronic equipment Electronic Equipment in compliance with the Waste Electrical and Electronic Equipment (WEEE). Directive. When accompanied by components of the device may contain lead or mercury, respectively, which must be recycled or disposed of in accordance with local, state, or federal laws.

  • Page 17: Chapter 1: About The Viera™ Portable Breast Ultrasound

    • Using the product incorrectly, or for purposes other than those intended and expressly stated by Clarius and/or Hologic, may relieve Clarius and/or Hologic or its agents from all or some responsibility for resultant noncompliance, damage, or injury. • Using portable and mobile radio-frequency (RF) communications equipment can affect the operation of medical equipment.

  • Page 18: Scanner Description

    Viera™ Portable Breast Ultrasound Scanner Description Scanner Description The Viera™ Portable Breast Ultrasound is a portable, general purpose, software controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through a COTS (commercial off-the-shelf) Apple iOS or Android™ device. The Viera™...
  • Page 19 Viera™ Portable Breast Ultrasound Scanner Description Charger Input: 100-240 VAC, 50/60 Hz, 0.5-0.2 A Output: 12 VDC, 1.5 A Scanner 7.2 V/2350 mAh • Clarius App • Scanners: All scanners have 192 elements The concept of the Viera™ Portable Breast Ultrasound and software is primarily to provide an easy to use, high-performance, low-cost, ultrasound platform for teaching and clinical applications.

  • Page 20: Scanner Dimensions

    Viera™ Portable Breast Ultrasound Scanner Dimensions • Using the scanner in the patient environment may be unsafe if the following conditions exist: (1) Extremes in humidity (RH<15% and RH>90%). (2) Ambient temperatures that are excessively high (40°C / 104°F) or excessively low (0°C / 32°F). Users will be trained medical professionals (e.g., doctors, nurses, technicians) with previous training in ultrasound.

  • Page 21: Product Usage

    Viera™ Portable Breast Ultrasound Product Usage Product Usage Indications for Use The Viera™ Portable Breast Ultrasound is a software-based ultrasound imaging system and accessories, intended for diagnostic imaging. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: abdominal, intra-operative (non- neurological) , pediatric, small organ, musculo-skeletal (conventional, superficial), peripheral vessel, carotid, and procedural guidance of needles into the body.
  • Page 22 Viera™ Portable Breast Ultrasound Product Usage Viera™ Scanner ™ S EVICE IERA CANNER NTENDED IAGNOSTIC ULTRASOUND IMAGING OR FLUID FLOW ANALYSIS OF THE HUMAN BODY AS FOLLOWS Clinical Application Mode of Operation General Specific Color Power Combined Other* (Track 1 Only) (Tracks 1 &...
  • Page 23 Viera™ Portable Breast Ultrasound Product Usage ™ S EVICE IERA CANNER NTENDED IAGNOSTIC ULTRASOUND IMAGING OR FLUID FLOW ANALYSIS OF THE HUMAN BODY AS FOLLOWS Peripheral Peripheral Vessel B+M; B+CD; Note 1 Vessel B+PD Other (Carotid) B+M; B+CD; Note 1 B+PD N = new indication;...

  • Page 24: Contraindications

    Viera™ Portable Breast Ultrasound Product Usage Contraindications For Use Outside USA Do not use the Viera™ Portable Breast Ultrasound in the following situations. Doing so may produce images with inaccurate results: • Patients who have had surgery, which may have changed the composition of the examining tissue (for example, a mastectomy), as this could skew or alter the measured density.

  • Page 25: Hardware

    Hologic representative. Disposal Hologic is an active participant in the protection of the natural environment. The equipment and its accessories are designed and manufactured according to environmental protection guidelines, and the disposal of this equipment is intended to follow the same principles. The equipment materials that are essential for functionality are also harmful to the natural environment, therefore, you must dispose these materials appropriately.

  • Page 26: Confidentiality

    Viera™ Portable Breast Ultrasound Security You may run into situations where no wireless access point is available. Using an untrusted wireless access point may allow malicious parties to see your Wi-Fi signals, perform harmful actions, and view communications between the two smart devices. When no secure access point is available, operate the Clarius App in Wi-Fi Direct mode, and it will automatically set up encryption.

  • Page 27: Integrity

    Viera™ Portable Breast Ultrasound System Requirements Integrity Integrity of the data transmitted between the Viera™ Portable Breast Ultrasound and the Clarius App is assured as follows: • Authenticated encryption prevents malicious users from intercepting and modifying data. • Integrity checks ensure completion and validity of data received. If any data is incomplete or invalid, it is discarded.
  • Page 28 Viera™ Portable Breast Ultrasound System Requirements • Supports Bluetooth LE v4.0+ • Supports Wi-Fi 802.11n and Wi-Fi Direct • 8 GB of storage (on-board) • 512 MB of memory Operating System: • Android™ 4.4.2 (API 19)+ or Apple iOS 9.0+ Processor: •...

  • Page 29: Chapter 2: A Quick Tour

    A Quick Tour Overview of the Interface Icons Menu Icons Menu icons are navigational tools at the top of the screen that takes you to a different page. CONS Home page. Support page. Scanners page. Settings page. Scan QR Code page. Display menu list.
  • Page 30 Viera™ Portable Breast Ultrasound Overview of the Interface Tools Icons Tool icons are task buttons that perform an action when you select them. CONS Discard selected item. Save image. Freeze/unfreeze a live- scanning image. Disable auto-freeze. Return to previous To flip the image on its Disconnect active page.

  • Page 31: Menu Options

    Viera™ Portable Breast Ultrasound Overview of the Interface Status Icons Status icons are view-only indicators that animate or change color to show the status of a component. STATUS CONS Quality of network connection is good. Image is zoomed out. Yellow, orange, or red indicates varying degrees of congestion.
  • Page 32 Viera™ Portable Breast Ultrasound Overview of the Interface Support To access the Support page, select Displays the following buttons: • What’s New: Takes you to the webpage containing frequently asked questions. • Tutorials: Takes you to the webpage containing tutorials. •...
  • Page 33 Viera™ Portable Breast Ultrasound Overview of the Interface Options • Control Placement: The location of the controls on the Imaging page. • Scanner Shutdown Timeout (minutes): Select the number of minutes of inactivity before the scanner shuts down. • Scanner Performance: •...
  • Page 34 Press to clear the log files. Note that deleting these log files could make it difficult or impossible for Hologic Technical Support to provide help in certain situations. Scanner Information Connect the Clarius App to a Viera™ Portable Breast Ultrasound to view the following information: •...
  • Page 35 Viera™ Portable Breast Ultrasound Overview of the Interface This page displays a list of completed exams and the status of any uploads or exports.  To view exams currently uploading to the Clarius Cloud: Go to the home screen and select Clarius Cast To access the Clarius Cast page, select User Manual version 4.2.0...
  • Page 36 Viera™ Portable Breast Ultrasound Overview of the Interface When using the QR Code® / barcode reader, if you have multiple barcodes close to each other, adjust the frame to ensure you restrict the frame size to display only one barcode in the window.
  • Page 37 Viera™ Portable Breast Ultrasound Overview of the Interface Displays the following information: • Version of the Clarius App and Viera™ Portable Breast Ultrasound software • Copyright information Links to: • Terms & Conditions • Privacy Policy • Acknowledgments • About Us Social media pages for: Facebook Twitter...

  • Page 38: Screen Overview

    Viera™ Portable Breast Ultrasound Screen Overview Sign Out Select to sign out of the Clarius App. If an exam is currently in progress, it will be saved in the list of in-progress exams. Screen Overview Sign-in Page When you open the Clarius App, it displays a sign-in screen. •...

  • Page 39: Scanners Page

    Viera™ Portable Breast Ultrasound Screen Overview Scanners Page When you sign in, the Clarius App displays the Scanners page. This page lists active scanners in your area to which your institution has access rights. If your Clarius App cannot locate your scanner, either because the scanner is powered off or because it is located outside its Bluetooth range, the scanner is grayed out on the list.

  • Page 40: Workflows Page

    Viera™ Portable Breast Ultrasound Screen Overview • Wi-Fi Direct: The scanner creates a peer-to-peer network connection using Wi-Fi protocol. • the name of your Wi-Fi network • Wi-Fi Direct Channel: This is shown if you have Wi-Fi Direct selected. For best results, keep the Auto option selected, it auto-connects the Clarius App to the most recently used Viera™...

  • Page 41: Patient Demographics

    Viera™ Portable Breast Ultrasound Screen Overview ™ S ORKFLOWS VAILABLE WITH THE IERA CANNER Workflow B-Mode M-Mode Power Color Needle Enhance PW Doppler Doppler Doppler Breast Dense Breast Interventional Radiology a. US only. Patient Demographics This is where you enter the patient’s basic information. You can tap on a field to display a barcode icon and scan their ID bracelet using your smart device's barcode scanner.

  • Page 42: Imaging Page

    Viera™ Portable Breast Ultrasound Screen Overview Imaging Page This is the live imaging screen. User Manual version 4.2.0...

  • Page 43: Review Page

    Viera™ Portable Breast Ultrasound Screen Overview Review Page When you have finished imaging, you can evaluate and edit findings that were acquired during the exam. Impressions Page After reviewing the images, use this page to record your findings. User Manual version 4.2.0...

  • Page 44: System Capabilities

    Software/firmware is updating. Do not remove battery. a. Remove the battery from the scanner, wait 10 seconds, re-insert the battery, and re-connect it to your smart device. If symptoms persist, contact Hologic. Audible Notifications The following table defines the audible indicators the Viera™ Portable Breast Ultrasound...

  • Page 45: Sleep Mode

    Viera™ Portable Breast Ultrasound System Capabilities 3 quick beeps Bluetooth is ready 2 tone-increasing pitches Power on 2 tone-decreasing pitches Power off 1 beep every few seconds Critically low battery 4 long alerts Embedded processor is preparing for software update 4 short beeps No network connected 4 quick beeps...

  • Page 46: Scanner Locator

    If you require more training on the Viera™ Portable Breast Ultrasound, see the tutorials on www.clarius.com/category/education. Need More Help? If you require additional assistance, you can do one of the following: • Refer to the Clarius FAQ at www.clarius.com/support/faq • Please contact Hologic Technical Support. User Manual version 4.2.0...

  • Page 47: Chapter 3: Using The Viera™ Portable Breast Ultrasound

    Using the Viera™ Portable Breast Ultrasound This chapter explains how to install and use your Viera™ Portable Breast Ultrasound safely and effectively. Refer to Safety on page 87 before handling the Viera™ Portable Breast Ultrasound. Your Viera™ Portable Breast Ultrasound is already activated and ready for use.

  • Page 48: Android

    Viera™ Portable Breast Ultrasound Updating the Viera™ Portable Breast Ultrasound Note: Restoring factory settings on your iOS device deletes the Clarius App from your home screen. If this occurs, reinstall the Clarius App. Android™ The Clarius App is available from the Google Play Store, a Google-operated digital media store where you can download applications for your smart device.

  • Page 49: Inserting & Removing The Battery

    Viera™ Portable Breast Ultrasound Inserting & Removing the Battery  To update the firmware: Tap Update. During the updating process, do not remove the battery. If the battery level is too low, the system will decline the update. During the update, the Viera™ emits a purple flashing light. Also, a purple indicator displays at the top right of the screen.

  • Page 50: Turning The System On & Off

    Viera™ Portable Breast Ultrasound Turning the System on & off Turning the System on & off Starting the Clarius App Before you begin using the Viera™ Portable Breast Ultrasound, make sure you have the Viera™, and also your smart device with the Clarius App installed on it. ...

  • Page 51: Signing Out

    Viera™ Portable Breast Ultrasound Connecting Your Smart Device to Viera™ Signing out  To sign out: 1. Select the Sign Out menu option. 2. Select Yes. If you want to remain signed in, select No. Connecting Your Smart Device to Viera™ If the active Viera™...

  • Page 52: Connecting Android™ Devices To Scanners

    Viera™ Portable Breast Ultrasound Managing Exams 3. Return to the Clarius App. The status light on the selected Viera™ turns blue, indicating its connection to your smart device. All other Viera™ Portable Breast Ultrasounds remain in standby mode. Workflows that apply to the selected Viera™ become enabled. Next, select a workflow.

  • Page 53: Pausing An Exam

    Viera™ Portable Breast Ultrasound Managing Exams  To begin a new exam: From the Workflows page, select a workflow. The Clarius App displays the last-used workflow at the top of the screen. Once you have selected a workflow, you can enter the patient’s information. See Entering Patient Information on page 46.

  • Page 54: Resuming A Paused Exam

    Viera™ Portable Breast Ultrasound Managing Patient Information Resuming a Paused Exam  To continue an in-progress exam: 1. Go to either the Scanners page or the Workflows page. 2. Tap 3. Select Open Exam. The application takes you to the Patient Demographics page. To discard an in-progress exam, select End Exam.

  • Page 55: Populating Indications

    Viera™ Portable Breast Ultrasound Selecting Scanning Modes Populating Indications Enter notes on this page. When you have entered all the indications, tap to go to the next page to begin imaging. For information on imaging, see Imaging on page 52. Selecting Scanning Modes ...

  • Page 56: Color Doppler

    Viera™ Portable Breast Ultrasound Selecting Scanning Modes Color Doppler This scanning mode estimates the average velocity of flow within a vessel by color-coding the information. The direction of blood flow toward and away from the ultrasound transducer is represented by red and blue. ...
  • Page 57 Viera™ Portable Breast Ultrasound Selecting Scanning Modes  To reverse the flow colors:  To view the image in normal or slow speed: 1. Tap to display a list of options. 2. Tap to view in slow speed. 3. Tap to return to normal speed.
  • Page 58 Viera™ Portable Breast Ultrasound Selecting Scanning Modes  To reshape the yellow frame: 1. Drag the yellow frame to display arrows. 2. Press and hold , then drag it horizontally.  To move the yellow frame: Drag the yellow frame to a new location. User Manual version 4.2.0...

  • Page 59: Power Doppler

    Viera™ Portable Breast Ultrasound Selecting Scanning Modes Power Doppler This scanning mode is used to obtain images that are difficult to acquire with standard color Doppler. It provides greater detail of blood flow, especially in vessels that are located inside organs.

  • Page 60: Imaging

    Viera™ Portable Breast Ultrasound Imaging  To view the image in M-Mode: and then The M-line appears over the image. You can adjust its placement before adding the spectrum.  To adjust the line placement: Tap and hold the line, then drag. When you release the line, the spectrum displays on the screen.

  • Page 61: Adjusting Gain

    Viera™ Portable Breast Ultrasound Imaging Adjusting Gain Turning Auto-Gain on & off The system selects the auto-gain mode by default. When auto-gain is turned on, displayed on the screen. Auto-gain automatically adjusts the gain of B-Mode images by detecting the noise floor and signal strength in the image. You can turn off auto-gain and adjust the gain manually.
  • Page 62 Viera™ Portable Breast Ultrasound Imaging 2. Slide the bars left and right to adjust the gain. Manually Adjusting Gain  To manually adjust gain: 1. Make sure auto-gain is turned off. If you see , you have auto-gain turned on. To turn it off, see Turning Auto-Gain on &...

  • Page 63: Using The Center Line

    Viera™ Portable Breast Ultrasound Imaging Saving the image retains the gain adjustment. Using the Center Line The center line tool is a dotted vertical line displayed down the center of the imaging screen. It can be used, for example, to guide the needle's location during needle guidance procedures. ...

  • Page 64: Using Needle Enhance

    Viera™ Portable Breast Ultrasound Imaging  To remove the guidance tool: • Repeat the steps for displaying this tool. • Freeze the imaging screen. Using Needle Enhance If you are using a linear scanner, the Needle Enhance feature is available in the tools list. Using this feature highlights the needle inside the tissue.

  • Page 65: Using Automated Heart Rate

    Viera™ Portable Breast Ultrasound Imaging Using Automated Heart Rate The automated heart rate feature is available in the cardiac workflow. When you scan the heart, it automatically detects and measures the heart rate.  To use the automated heart rate feature: 1.

  • Page 66: Freezing/Unfreezing Cineloops

    Viera™ Portable Breast Ultrasound Imaging Select the cardiac workflow. When the Viera™ Portable Breast Ultrasound detects the heart rate, it displays it on the screen. Freezing/Unfreezing Cineloops A cineloop is a sequence of still images presented in the form of a video. By default, the system retains the last 20 seconds of the imaging session.
  • Page 67 Viera™ Portable Breast Ultrasound Imaging This pauses the cineloop. The icon decreases in size, the Viera™ Portable Breast Ultrasound changes to standby mode, and the light turns blue. When you freeze a cineloop, you can: • Add annotations. For instructions, see Using Annotations on page 64. •...

  • Page 68: Capturing Cineloops & Images

    Viera™ Portable Breast Ultrasound Imaging Capturing Cineloops & Images When you have finished capturing your cineloops and images, there is no need to manually upload them to the Clarius Cloud. When you disconnect your smart device from the Viera™ at the end of the scanning session, your smart device reconnects to the network and automatically uploads them to the Clarius Cloud.
  • Page 69 Viera™ Portable Breast Ultrasound Imaging 3. Once you have marked the desired range, tap to save this. The Clarius App saves both the original capture and the edited capture. Saving Images 1. During live imaging, tap 2. Slide your finger along the horizontal scroll bar to view the sequence of still images from the recorded cineloop.

  • Page 70: Zooming In & Out

    Viera™ Portable Breast Ultrasound Imaging Zooming in & out  To expand (zoom in) an area of the image: Spread the image. Alternatively, tap and drag up to the plus sign (“ + “).  To reduce (zoom out) an area of the image: Pinch the image.

  • Page 71: Changing Depth

    Viera™ Portable Breast Ultrasound Imaging  To pan or move the magnified image: Tap the image and drag it. Changing Depth While live imaging, you can adjust the depth of the scan.  To change depth: 1. Make sure you are using B-Mode and default zoom. 2.

  • Page 72: Using Annotations

    Viera™ Portable Breast Ultrasound Imaging Using Annotations Labeling Images To identify specific objects, or to describe an entire image, you can add text labels on the imaging screen. There are two main types of text labels: • Image label: Text referring to the entire cineloop or image, placed in one of the four corners of the imaging screen.
  • Page 73 Viera™ Portable Breast Ultrasound Imaging You can create labels either before or after capturing the image.  To create a label: 1. Tap and select The screen displays a text field. 2. Enter text and tap . Alternatively, press the Enter key. Note: To create multiples labels, tap The label defaults to an image label and is placed in the corner of the screen.
  • Page 74 Viera™ Portable Breast Ultrasound Imaging Action Image Label Pinned label Zooming in and out Zooming in/out has no effect on image Zooming in/out retains pinned labels on the labels. They are retained in the corner of objects. If the object is outside the view, the the view.

  • Page 75: Using The Measuring Tools

    Viera™ Portable Breast Ultrasound Imaging Using the Measuring Tools Measurements can be made using B-Mode. To make measurements, tap to display a list of tools, then select from the options. When you tap to mark your points on the screen, the system displays a green cross with a surrounding purple circle.

  • Page 76: Using The View-Sharing Mode

    Viera™ Portable Breast Ultrasound Imaging You are responsible for image quality and diagnosis. Ensure that the data used for inspection and diagnosis is sufficient, both spatially and temporally, for the measurement method. Measurement Accuracy Table Each figure below is derived from the sum of all parts of the Viera™ Portable Breast Ultrasound.
  • Page 77 Viera™ Portable Breast Ultrasound Imaging 4. Go to the second device (we'll call this the “listening device”). 5. Go to the main menu and select the Clarius Cast option to display the Scan QR Code® page. User Manual version 4.2.0...

  • Page 78: Using Chromecast

    Viera™ Portable Breast Ultrasound Review Findings 6. Align the scanning area with the QR Code of the scanning device. The frame can be adjusted by dragging the corners. The scanning device automatically captures the QR Code. The listening device can zoom into a scanned image, but cannot perform any other action. When the driver disconnects their smart device from the Viera™...

  • Page 79: Populating Impressions

    Viera™ Portable Breast Ultrasound Populating Impressions Populating Impressions Once you have reviewed the images, record your findings from the exam. Once you have entered your impressions, you can end the exam. For information on ending the exam, see Ending an Exam on page 45. Exporting Exams When you have finished an exam, you can export it using the following options: •...
  • Page 80 Also, the system runs a series of tests in the background. If your smart device is not connected to a wireless or cellular network, the logs are queued until you have network connectivity. For more information, please contact Hologic Technical Support. Recharging Batteries Because the Viera™...

  • Page 81: System Maintenance

    This downloads logs from the Viera™ Portable Breast Ultrasound, then combines them with the logs from the Clarius App. This bundle is then sent to the Clarius Cloud where they can be retrieved by a Hologic Technical Support staff. The log files contain diagnostic information. User Manual version 4.2.0...
  • Page 82 Viera™ Portable Breast Ultrasound Maintenance If the log files grow too large, you may want to delete them to save space on your smart device. To delete the log files, go to the Settings menu. User Manual version 4.2.0...

  • Page 83: Chapter 4: Accessories

    Accessories To order these additional accessories, contact your Hologic representative: • Clarius Dock (CIDN 99-02-00025): This docking station combines a cooler (for up to three scanners) and a battery charger (for up to five batteries). • Clarius Fan (CIDN 99-02-00028): Attaching this fan to the Viera™...

  • Page 84: Parts

    Viera™ Portable Breast Ultrasound Clarius Dock Parts The Clarius Dock is made up of the following parts: • A fully-assembled docking station (CIDN 99-02-00025). • A power supply (CIDN 50-02-00024) with a cord that is compatible with your country's socket and voltage. Figure 1: Clarius Dock Figure 2: Top View User Manual version 4.2.0...
  • Page 85 Viera™ Portable Breast Ultrasound Clarius Dock Figure 3: Right Side View Figure 4: Back View Before you begin using your Clarius Dock, clean and disinfect it. For cleaning and disinfecting instructions, see Cleaning & Disinfecting on page 81. Technical Specifications Input 12 VDC, 11.5 A Output...

  • Page 86: Setting Up

    • Do not place the Clarius Dock within 1.5m of the examination table/patient bed. • Do not touch the patient and the Clarius Dock at the same time. • If the AC power cord is damaged, contact Hologic for a replacement. Using the Clarius Dock Using the Scanner Coolers ...

  • Page 87: Maintenance

    Viera™ Portable Breast Ultrasound Clarius Dock Using the Viera™ Battery Charger  To charge the scanner battery: 1. Remove the battery from the scanner. 2. Insert the battery into one of the battery slots. There will be a click when the battery is fully inserted.

  • Page 88: Troubleshooting

    Viera™ Portable Breast Ultrasound Clarius Fan If your Clarius Dock requires servicing, contact your Hologic representative. Troubleshooting  The power does not turn on: The DC power connector may not be fully plugged into the Clarius Dock. Slide the rectangular portion of the DC power connector away from the metallic barrel and re- insert it into the DC jack on the Clarius Dock.

  • Page 89: Chapter 5: Cleaning & Disinfecting

    Cleaning & Disinfecting It is important to clean and disinfect the Viera™ Portable Breast Ultrasound immediately after use. This chapter will guide you through the cleaning and disinfecting process. The classification of cleaning and disinfecting you select will depend on the type of tissue the Viera™ Scanner comes into contact with. To find the correct classification, refer to Spaulding Classification on page 86.

  • Page 90: Cleaning

    Before cleaning, visually inspect the scanner to determine that it is free of any unacceptable deterioration, such as corrosion, discoloration, pitting, or cracked seals. If damage is evident, discontinue use and contact Hologic Technical Support. Cleaning the scanner requires that you select the proper cleaning level. Before you begin, determine the level of cleaning by referring to Spaulding Classification on page 86.

  • Page 91: Cleaning The Clarius Dock

    Viera™ Portable Breast Ultrasound Cleaning 7. Verify that all gel, particulate matter, and bodily fluids have been removed. 8. Repeat with new cleaning material if necessary. 9. To clean the battery, dampen another soft cloth using a compatible cleaner or disinfectant.

  • Page 92: Disinfecting

    Viera™ Portable Breast Ultrasound Disinfecting 4. Air-dry the Clarius Fan. Alternatively, towel-dry with a clean, non-linting cloth. When you are done, keep the two parts separate. You will be disinfecting them individually. Disinfecting Disinfecting the Viera™ Portable Breast Ultrasound Before you begin disinfecting, make sure you have cleaned the scanner (see Cleaning on page 82).
  • Page 93 6. Examine the scanner for damage, such as cracks or splitting where fluid can enter. If damage is evident, do not use the scanner and contact Hologic Technical Support. 7. Disinfect the battery and the battery connector by wiping with a cloth moistened with a compatible disinfectant.

  • Page 94: Disinfecting The Clarius Fan

    3. Air-dry. Alternatively, towel-dry with a clean, non-linting cloth. 4. Examine the Clarius Fan for damage, such as cracks or splitting. If damage is evident, do not use the fan and contact Hologic Technical Support. Spaulding Classification The level of cleaning and disinfecting required for your Viera™ Portable Breast Ultrasound is based on the Spaulding classification system.

  • Page 95: Chapter 6: Safety

    Safety This chapter provides instructions on the product's safe usage and offers information on safety guidelines. Pay special attention to warnings and cautions, and follow them before, during, and after operating the product: • Warnings indicate information vital to the safety of you, the operator, and the patient.

  • Page 96: Benefits & Risks

    Viera™ Portable Breast Ultrasound Safety Topics These mechanisms are discussed later. Benefits & Risks Ultrasound is widely used because it provides many clinical benefits to the patient and has an outstanding safety record. In more than three decades of use, there has been no known long- term negative side-effects associated to this technology.

  • Page 97: Product Safety

    -- WHO (World Health Organization) Product Safety Hologic is responsible for the safety of the scanners. The safety of your smart device is your responsibility. Always follow the safety guidelines provided with your smart device before, during, and after use.

  • Page 98: Battery Safety

    • Do not discard the battery in fire. • Do not open, crush, puncture, or short-circuit contacts. • If the battery leaks or emits an odor, remove it from the scanner and contact Hologic Technical Support. • If the battery emits an odor or heat, is deformed or discolored, or in any way appears abnormal during use, recharging or storage, immediately remove it and stop using it.

  • Page 99: Cleaning Safety

    Viera™ Portable Breast Ultrasound Safety Topics Cleaning Safety It is important to clean and maintain the ultrasound system and peripherals. Thorough cleaning is particularly important for pieces of peripheral equipment, because they contain electromechanical parts. If exposed to constant and excessive sunlight and humidity, the scanner will suffer in both performance and reliability.
  • Page 100 • Using paper or abrasive products. They damage the soft lens of the scanner's acoustic window. If the lens is damaged to the point that the scanner elements are exposed, stop using the scanner and please contact Hologic Technical Support immediately. Exposed scanner elements may cause burns or electric shock to the patient.

  • Page 101: Clinical Safety

    Viera™ Portable Breast Ultrasound Safety Topics Clinical Safety Syringe Safety • If the needle is not visible, do not perform the needle procedure. • Verify the location of the needle tip in the image. The Viera™ Portable Breast Ultrasound cannot visualize a needle that is out of plane. •...
  • Page 102 Viera™ Portable Breast Ultrasound Safety Topics prevent adverse reactions.) • Whenever latex comes in contact with mucous membranes, be alert to the possibility of an allergic reaction. • If an allergic reaction does occur and latex is suspected, advise the patient of a possible latex sensitivity and consider an immunologic evaluation.

  • Page 103: Alara Principle

    Viera™ Portable Breast Ultrasound Safety Topics Cavitation is the interaction of ultrasound with gas bubbles, causing rapid and potentially large changes in bubble size. These bubbles originate within materials at locations termed nucleation sites, the exact nature and source of which are not well understood in a complex medium such as tissue or blood.
  • Page 104 Viera™ Portable Breast Ultrasound Safety Topics Output display indices are designed to provide more quality information, to help guide the sonographers using ultrasound technology, in applying the ALARA principle. Some variables that affect the way output display indices can be used to implement the ALARA principle: •...
  • Page 105 Viera™ Portable Breast Ultrasound Safety Topics Indirect Controls Controls affecting imaging mode, freeze, and depth indirectly affect output. The imaging mode determines the nature of the ultrasound beam. Because freeze stops all ultrasound output but keeps the last image displayed on screen, you can use it to limit exposure time while studying an image and maintaining scanner position during a scan.
  • Page 106 Viera™ Portable Breast Ultrasound Safety Topics 1. Select the correct scanner frequency and application. 2. Start with a low output level. 3. Optimize the image by using focus, receiver gain, and other imaging controls. 4. If the image is still not diagnostically useful, increase output. Additional considerations: •...
  • Page 107 Viera™ Portable Breast Ultrasound Safety Topics unscanned modes (such as M-Mode or Doppler-type modes), the potential for heating tends to be deeper in the focal zone. • MI: This is continuously displayed over the range of 0.0 to 1.9, in increments of 0.1. TI Display The TI indicates any conditions that may lead to temperature increase on the surface of the body, within the body tissue, or at the point of focus of the ultrasound beam on bone.
  • Page 108 Viera™ Portable Breast Ultrasound Safety Topics • estimation algorithm accuracy Differences in system pulser voltage control and efficiencies are also contributor to variability. There are inherent uncertainties in the algorithms used to estimate acoustic output values over the range of possible system operating conditions and pulser voltages.
  • Page 109 Viera™ Portable Breast Ultrasound Safety Topics Acoustic output defaults are set when you select an application. Factory defaults vary with scanner, application, and mode. Defaults have been chosen below the FDA limits for intended use. • Imaging Mode Controls: When a new imaging mode is selected, both the TI and MI may change to default settings.
  • Page 110 Viera™ Portable Breast Ultrasound Safety Topics Acoustic Artifacts An acoustic artifact is information, present or absent in an image, which does not properly indicate the structure or flow being imaged. Examples of acoustic artifacts that hinder proper interpretation: • Added objects displayed as speckle, section thickness, reverberation, mirror image, comet tail, or ring down.
  • Page 111 Viera™ Portable Breast Ultrasound Safety Topics Brain 0.53 Heart 0.66 Kidney 0.79 Liver 0.43 Muscle 0.55 Skin line to measurement depth (cm) Center frequency of the scanner/system/mode combination (MHz) Because the ultrasonic path during an examination is likely to pass through varying lengths and types of tissue, it is difficult to estimate the true in situ intensity.
  • Page 112 Viera™ Portable Breast Ultrasound Safety Topics soft tissue is generally higher than 0.3 dB/cm MHz. When the path contains significant amounts of fluid, as in many first- and second-trimester pregnancies scanned transabdominally, this model may underestimate the in situ acoustical exposure. The amount of underestimation depends on each specific situation.

  • Page 113: Fire & Electrical Safety

    Viera™ Portable Breast Ultrasound Safety Topics COUSTIC EASUREMENT RECISION Wo is the ultrasonic power in milliwatts (mW) 6.2% is the center frequency in megahertz (MHz) (NEMA UD-2 <1% definition) PII.3 is the derated spatial-peak pulse intensity integral in joules per PII.3: 3.2% square centimeter (J/cm COUSTIC...

  • Page 114: Electromagnetic Safety

    Viera™ Portable Breast Ultrasound Safety Topics range, ultrasound scanner circuits are susceptible to RF interference. • A burn hazard may result from a surgical equipment with a defect in the high-frequency surgical neutral electrode connection. Do not use scanners with high-frequency surgical equipment.
  • Page 115 Viera™ Portable Breast Ultrasound Safety Topics Caution: • Using parts and accessories not recommended by Clarius may result in increased emissions or decreased immunity of the system. Use only accessories and peripherals recommended by Clarius. • EMC precautions for medical equipment must be followed according to the EMC information provided in that system's accompanying documents.
  • Page 116 Viera™ Portable Breast Ultrasound Safety Topics Electromagnetic Immunity Immunity Test IEC 60601-1-2 Test Level Compliance Level ESD @ battery mode transmitting and +/-2kV, +/-4kV, +/-8kV Contact +/-2kV, +/-4kV, +/-8kV contact charge mode* +/-2kV, +/-4kV, +/-8kV, +/-15kV Air +/-2kV, +/-4kV, +/-8kV, +/-15kV Air EN/IEC 61000-4-2 Radiated, radio frequency 3 V/M...
  • Page 117 Viera™ Portable Breast Ultrasound Safety Topics If you experience EMI, use caution if you continue using the system, or consider relocating your system. The following table describes typical interferences seen in imaging systems. It is impossible to describe all manifestations of interference, because it depends on many parameters of the transmitting equipment, for example, the type of modulation used by the signal carrier, the source type, and the transmitted level.
  • Page 118 Viera™ Portable Breast Ultrasound Safety Topics normal operation. If abnormal performance is observed, apply additional measures, such as reorienting or relocating the system. At 80 MHz and 800 MHz, the higher frequency range applies. The recommended separation distance guidelines in the following table may not apply to all situations.
  • Page 119 ECG cable can increase electromagnetic interference. Moving the cable or other medical equipment away from the location of the scanner or printer can result in reduced electromagnetic interference. If you find the interference's source, please contact Hologic Technical Support. Regulation of Low-Power Motor for Radio Wave Range NCC Warning:...

  • Page 120: Chapter 7: References

    References Compliance Statement Clarius products comply with international and national standards and laws. Users are responsible for ensuring that the chosen smart device and scanner are compliant with the law in the jurisdiction where the product is used. Clarius meets all regulatory standards listed in this chapter.

  • Page 121: Product Serial Number

    Viera™ Portable Breast Ultrasound The Viera™ Portable Breast Ultrasound Product Serial Number Clarius has assigned a unique serial number on each scanner. This serial number, displayed in the format PT-R-YYMM-zXXXX, is used to track quality control. We will use the serial number L738-A-1703-A0100 as an example to explain how to interpret this.

  • Page 122: Scanner Specifications

    Viera™ Portable Breast Ultrasound The Viera™ Portable Breast Ultrasound To reach an operating temperature of 20°C (68°F), the Viera™ Portable Breast Ultrasound requires approximately 30 minutes to: • Warm up from a storage temperature of -20°C (-4°F). • Cool down from a storage temperature of 50°C (122°F). Maximum scanner surface temperature is: •...

  • Page 123: Standards

    Viera™ Portable Breast Ultrasound Standards Standards Biocompatibility ANSI/ISO 10993-1:2009 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. Medical devices - Biological evaluation - Part 1: Evaluation and testing GB / T 16886.1-2011 GB / T 16886.5-2016 Biological evaluation of medical devices - Part 5: In vitro cytotoxicity test GB / T 16886.10-2016 Biological evaluation of medical devices - Part 10: Stimulation and delayed hypersensitivity test...

  • Page 124: Federal

    Viera™ Portable Breast Ultrasound Standards Federal Health Canada's MDR - Medical Devices Regulations SOR-98-282 Labeling ISO 60417:2014 - Graphical symbols for use on equipment. See Symbols Glossary on page 3. Quality Performance Reference No. Year Title AIUM/NEMA UD 2- 2009 NEMA Standards Publication UD 2-2004 (R2009) Acoustic Output 2004 Measurement Standard For Diagnostic Ultrasound Equipment,...
  • Page 125 Viera™ Portable Breast Ultrasound Standards GB/T 191 2008 Packaging and pictorial marking for handling of goods IEC 60601-1-2 2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic Capability - Requirements and tests IEC 60601-1-6 2013 Medical electrical equipment - Part 1-6: General requirements for basic...

  • Page 126: Security & Privacy

    Viera™ Portable Breast Ultrasound Standards IEEE 11073- 20601a 2010 Health informatics - Personal health device communication. Part 20601: Application profile - Optimized Exchange Protocols ISO 10993-1 2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process ISO 13485 2016...

  • Page 127: Doppler Sensitivity

    Viera™ Portable Breast Ultrasound Standards Doppler Sensitivity The following table shows the Doppler sensitivity of the Viera™ Scanner. Viera™ Scanner Depth (cm) Flow (mL/sec) Color/Doppler signal sensitivity 6.2 cm Flow sensitivity at depth 5.1 cm 0.5 ml/sec User Manual version 4.2.0...

  • Page 128: Acoustic Output Tables

    Viera™ Portable Breast Ultrasound Standards Acoustic Output Tables Viera™ Scanner: B-Mode & M-Mode COUSTIC UTPUT EPORTING ABLE FOR RACK ™, B-M & M-M CANNER ODEL IERA PERATION Index Label Scan Non-scan Non- scan aprt aprt 1 cm >1 cm Maximum Index Value 1.00 0.235 0.018...

  • Page 129: Viera™ Scanner: Color Doppler Mode

    Viera™ Portable Breast Ultrasound Standards Viera™ Scanner: Color Doppler Mode COUSTIC UTPUT EPORTING ABLE FOR RACK ™, C CANNER ODEL IERA OLOR OPPLER PERATION Index Label Scan Non-scan Non- scan aprt aprt 1 cm >1 cm Maximum Index Value 0.84 0.159 Associated (MPa)

  • Page 130: Viera™ Scanner: Needle Enhance Mode

    Viera™ Portable Breast Ultrasound Standards Viera™ Scanner: Needle Enhance Mode COUSTIC UTPUT EPORTING ABLE FOR RACK ™ S , B-M CANNER ODEL IERA CANNER PERATION Index Label Scan Non-scan Non- scan aprt aprt 1 cm >1 cm Maximum Index Value 1.08 0.198 Associated...

  • Page 131: Control Effects Guidance Documents

    Viera™ Portable Breast Ultrasound Control Effects Guidance Documents Control Effects Guidance Documents For more information about ultrasonic bioeffects and related topics, see the following: • “Bioeffects and Safety of Diagnostic Ultrasound.” AIUM Report, January 28, 1993. • “American Institute of Ultrasound in Medicine Bioeffects Consensus Report.” Journal of Ultrasound in Medicine, Volume 27, Issue 4, April 2008.

  • Page 132: Cleaner & Disinfectant Details

    Because of the large number of available cleaners and disinfectants, it is impossible to have an all-inclusive list. If you are unsure of the suitability of a particular product, please contact Hologic Technical Support for more information. Cleaner & Disinfectant Details...

  • Page 133: Sterilization Systems

    Viera™ Portable Breast Ultrasound Glossary of Terms Sani-Cloth® HB Germicidal Disposable Wipe Wipe Alcohol, Quaternary Ammonia Sani-Cloth® Plus Germicidal Disposable Cloth Wipe Alcohol, Quaternary Ammonia Tristel Trio Wipes System Pre-clean wipe, Enzymes, Chlorine Dioxide Sporicidal wipe, Rinse wipe trophon EPR Mist Hydrogen Peroxide trophon®2...
  • Page 134 Viera™ Portable Breast Ultrasound Glossary of Terms Equivalent beam diameter as a function of axial distance z, and is equal to [(4/)(W (z))] where I (z) is the temporal-average intensity as a function of z in centimeters. @PII Equivalent beam diameter at the point where the free-field, spatial-peak pulse intensity integral is a maximum in centimeters.
  • Page 135 Viera™ Portable Breast Ultrasound Glossary of Terms MI (mechanical index) An indication of the likelihood of mechanical bioeffects occurring. The higher the MI, the greater the likelihood of mechanical bioeffects. Pulse duration (microseconds) associated with the transmit pattern giving rise to the reported value of MI.

  • Page 136: Acoustic Artifacts

    Viera™ Portable Breast Ultrasound Glossary of Terms non-scan The soft tissue thermal index in the non-autoscanning mode. Derated ultrasonic power at axial distance z1 in units of milliwatts. Ultrasonic power, except for TIS , in which case it is the ultrasonic power passing through a scan one-centimeter window in units of milliwatts.
  • Page 137 Viera™ Portable Breast Ultrasound Glossary of Terms Enhancement An increased relative amplitude of echoes caused by an intervening structure of low attenuation. Focal enhancement (focal banding) The increased intensity in the focal region that appears as a brightening of the echoes on the display.

  • Page 138: Known Issues

    Viera™ Portable Breast Ultrasound Known Issues Scattering Is the diffuse, low-amplitude sound waves that occur when acoustic energy reflects off tissue interfaces smaller than a wavelength. In diagnostic ultrasound, Doppler signals come primarily from acoustic energy back-scattered from red blood cells. Shadowing Is the reduction in echo amplitude from reflectors that lie behind a strongly reflecting or attenuating structure.

  • Page 139: Revision History

    Viera™ Portable Breast Ultrasound Revision History Revision History OCUMENT EVISION ISTORY Software Version Revision Date Description 4.1.0 May 22, 2018 Added information for virtual scanners, automated heart rate feature, post-capture freeze, prospective/retrospective viewing. Removed auto-deletion feature, Clarius Clip-ons. 4.2.0 July 24, 2018 Updated Indications for Use, Intended Use tables, Contraindications, Cleaner &...
  • Page 140 Headquarters: Clarius Mobile Health Corp. #350 - 3605 Gilmore Way Burnaby, BC V5G 4X5 Canada 1-778-800-9975 www.clarius.com 0086 Emergo Europe, Prinsessegracht 20 2514 AP, The Hague, The Netherlands www.anatel.gov.br...

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