Hologic Viera Portable User manual

Viera™Portable
Breast Ultrasound
User Manual

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.
(“Clarius“) and is provided for the sole use of the individual or entity to whom it is addressed
and therefore these materials must be kept in the strictest confidence. No portion of this
manual may be copied, reproduced, republished, modified, sold, disclosed, or distributed
without the prior written permission of Clarius. Unauthorized copying or distribution of this
manual, in addition to infringing copyright, may reduce the ability of Clarius to provide updates
and current information to users.
Clarius has taken care to ensure the accuracy of this document, however, revisions may not be
possible in all situations. Information in this document may be subject to change without
notice, and Clarius assumes no liability for errors or omissions. Clarius reserves the right to
make changes without further notice to any products herein to improve reliability, function, or
design. Clarius may make improvements or changes in the products or programs described in
this document at any time.
These materials may contain third-party copyright and/or trademark materials, the use of which
has not always been specifically authorized by the intellectual property owner. All copyrights
and/or trademarks contained in these materials are the sole and exclusive property of their
respective owners.
“Clarius”, the Clarius logo, “Ultrasound Anywhere,” “Point-and-Shoot Ultrasound”, “Act One”,
“Tri-Scanner”, and “My New Stethoscope” are trademarks or registered trademarks, and are the
sole and exclusive property of Clarius.
The Clarius products/services referenced in this document may be covered by one or more
patents or pending patent applications. See www.clarius.com/patents for details.
All names used in Clarius (whether online, in print, or any other media) are fictitious and are
used herein for the purposes of example and demonstration on how to use the Viera™ Portable
Breast Ultrasound. Any similarity to real people is a coincidence.
© 2018 Clarius Mobile Health Corp.
All rights are reserved. Reproduction or transmission in whole or in part, in any form or by any
means, electronic, mechanical or otherwise, is prohibited without the prior written consent of
the copyright owner.
Published in Canada.
15-03-00055

Hologic Technical Support
USA Support Center: [phone]
[phone]
[email protected]
European Support Center: [phone]
[email protected]
Australia Support Center: 1800 264 073
[phone]

i
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 .......................................................................................................... 16
Hardware.................................................................................................................... 17
Warranty .......................................................................................................................... 17
Disposal ........................................................................................................................... 17
Security ...................................................................................................................... 17
Information Security..................................................................................................... 17
Network Security........................................................................................................... 17
Confidentiality ............................................................................................................... 18
Integrity ........................................................................................................................... 19
Availability ...................................................................................................................... 19
Accountability ................................................................................................................ 19
System Requirements............................................................................................. 19
Chapter 2: A Quick Tour ............................................................................21
Overview of the Interface...................................................................................... 21
Icons ................................................................................................................................. 21
Menu Options................................................................................................................. 23
Screen Overview ...................................................................................................... 30
Sign-in Page....................................................................................................................30

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User Manual version 4.2.0 ii
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™ Portable Breast Ultrasound .........................39
Downloading the Clarius App................................................................................39
Apple iOS .........................................................................................................................39
Android™..........................................................................................................................40
Updating the Viera™ Portable Breast Ultrasound.............................................40
Software Updates...........................................................................................................40
Firmware Updates..........................................................................................................40
Inserting & Removing the Battery ........................................................................41
Inserting the Battery .....................................................................................................41
Removing the Battery ...................................................................................................41
Turning the System on & off..................................................................................42
Starting the Clarius App................................................................................................42
Exiting the Clarius App .................................................................................................42
Signing in & out ........................................................................................................42
Signing in .........................................................................................................................42
Signing out.......................................................................................................................43
Connecting Your Smart Device to Viera™ ..........................................................43
Connecting Apple iOS Devices to Scanners ............................................................43
Connecting Android™ Devices to Scanners.............................................................44
Managing Exams .......................................................................................................44
Starting New Exams.......................................................................................................44
Pausing an Exam.............................................................................................................45
Ending an Exam ..............................................................................................................45

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User Manual version 4.2.0 iii
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 & Images ...................................................................................60
Zooming in & out ...........................................................................................................62
Changing Depth..............................................................................................................63
Flipping Images ..............................................................................................................63
Using Annotations..........................................................................................................64
Using the Measuring Tools...........................................................................................67
Using the View-Sharing Mode.....................................................................................68
Using Chromecast™.......................................................................................................70
Review Findings........................................................................................................70
Reviewing Cineloops & Images ..................................................................................70
Deleting Items ................................................................................................................70
Populating Impressions...........................................................................................71
Exporting Exams .......................................................................................................71
Maintenance ..............................................................................................................71
Hardware Maintenance.................................................................................................71
System Maintenance .....................................................................................................73
Chapter 4: Accessories .............................................................................75
Clarius Dock ...............................................................................................................75
Parts ..................................................................................................................................76
Setting up.........................................................................................................................78
Using the Clarius Dock..................................................................................................78
Maintenance....................................................................................................................79
Troubleshooting .............................................................................................................80

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User Manual version 4.2.0 iv
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
Interactions with Matter...............................................................................................87
Studies ..............................................................................................................................87
Benefits & Risks..............................................................................................................88
Safety Topics .............................................................................................................88
Product Safety ................................................................................................................89
Battery Safety .................................................................................................................90
Cleaning Safety ..............................................................................................................91
Clinical Safety .................................................................................................................93
Biological Safety ............................................................................................................93
ALARA Principle ..............................................................................................................95
Fire & Electrical Safety .................................................................................................105
Electromagnetic Safety ................................................................................................106
Chapter 7: References ..............................................................................112
Compliance Statement............................................................................................112
The Viera™ Portable Breast Ultrasound..............................................................112
Authorized Representative..........................................................................................112
Product Classification ...................................................................................................112
Product Serial Number..................................................................................................113
System Specifications...................................................................................................113
Scanner Specifications .................................................................................................114
Standards....................................................................................................................115
Biocompatibility.............................................................................................................115

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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 & Disinfectants ........................................................................................123
Cleaner & Disinfectant Usage.....................................................................................123
Cleaner & Disinfectant Details ...................................................................................124
Sterilization Systems.....................................................................................................125
Glossary of Terms.....................................................................................................125
Acoustic Outputs............................................................................................................125
Acoustic Artifacts ...........................................................................................................128
Known Issues .............................................................................................................130
Revision History........................................................................................................131

1
About This Manual
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.
This document contains the following information:
• About the Viera™ Portable Breast Ultrasound: Describes the product, and lists technical
specifications, and its intended use.
• A Quick Tour: Shows you how to get started and begin scanning.
• Using the Viera™ Portable Breast Ultrasound: Introduces you to the features and concepts,
helps you set up your system, and explains the tasks you can perform.
• Accessories: Describes additional accessories you can purchase for use with your Viera™
Portable Breast Ultrasound.
• Cleaning & Disinfecting: Explains how to clean and disinfect your scanner.
• Safety: Outlines important safety standards, principles, and policies to follow when using
the product.
• References: Offers information such as product standards, regulatory requirements, terms
and conditions, glossary of terms, and acoustic output data.
Access to user documentation may be affected by: Internet availability and accessibility,
website availability, and local electromagnetic interference.
Target Audience
This document is written for trained medical professionals who operate and maintain your
Viera™ Portable Breast Ultrasound. It contains instructions and reference material pertaining
to the usage and maintenance of the product.
To obtain a printed copy of this manual at no additional cost, please contact Hologic
Technical Support.

Viera™ Portable Breast Ultrasound
User Manual version 4.2.0 2
Document Conventions
Touch Gestures
Gesture Title of
gesture
Description
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.
Tap Touch a control with your finger.
Press and hold Touch the screen for a short time without moving your finger.
Spread Touch the screen with two fingers and move them apart.
Swipe Touch the screen with your finger and move the finger in a quick motion right,
left, up, or down.

Viera™ Portable Breast Ultrasound
User Manual version 4.2.0 3
Icons
Symbols Glossary
The symbols shown in this document and on the Viera™ Portable Breast Ultrasound are
compliant with current versions of the following standards: ISO 7000, ISO 7010, IEC 6417, (EN)
ISO 15223-1, and EN 15986.
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.
STANDARD: ISO 7000—GRAPHICAL SYMBOLS FOR USE ON EQUIPMENT—REGISTERED SYMBOLS
Symbol Reference Title Description
3082 Manufacturer Indicates the medical device manufacturer, as defined
in EU Directives 90/385/EEC, 93/42/EEC and 98/79/
EC.
2497 Date of manufacture Indicates the date when the medical device was
manufactured.
2607 Use by date Indicates the date after which the medical device is not
to be used.
2492 Batch code Indicates the manufacturer's batch code so that the
batch or lot can be identified.
2493 Catalogue number Indicates the manufacturer's catalogue number so that
the medical device can be identified.
2498 Serial number Indicates the manufacturer's serial number so that a
specific medical device can be identified.

Viera™ Portable Breast Ultrasound
User Manual version 4.2.0 4
2499 Sterile Indicates a medical device that has been subjected to
a sterilization process.
2500 Sterilized using aseptic
processing techniques
Indicates a medical device that has been
manufactured using accepted aseptic techniques.
2501 Sterilized using ethylene
oxide
Indicates a medical device that has been sterilized
using ethylene oxide.
2502 Sterilized using irradiation Indicates a medical device that has been sterilized
using irradiation.
2503 Sterilized using steam or
dry heat
Indicates a medical device that has been sterilized
using steam or dry heat.
2608 Do not resterilize Indicates a medical device that is not to be resterilized.
2609 Non-sterile Indicates a medical device that has not been subjected
to a sterilization process.
2606 Do not use if package is
damaged
Indicates a medical device that should not be used if
the package has been damaged or opened.
3084 Sterile fluid path Indicates the presence of a sterile fluid path within the
medical device in cases when other parts of the
medical device, including the exterior, might not be
supplied sterile.
0621 Fragile; handle with care Indicates a medical device that can be broken or
damaged if not handled carefully.
0624 Keep away from sunlight Indicates a medical device that needs protection from
light sources.
0615 Protect from heat and
radioactive sources
Indicates a medical device that needs protection from
heat and radioactive sources.
0626 Keep away from rain Indicates a medical device that needs to be protected
from moisture.
0534 Lower limit of temperature Indicates the lower limit of temperature to which the
medical device can be safely exposed.
STANDARD: ISO 7000—GRAPHICAL SYMBOLS FOR USE ON EQUIPMENT—REGISTERED SYMBOLS

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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
device can be safely exposed.
0224 Measure humidity Indicates the range of humidity to which the medical
device can be safely exposed.
2621 Atmospheric pressure
limitation
Indicates the range of atmospheric pressure to which
the medical device can be safely exposed.
0659 Biological risks Indicates that there are potential biological risks
associated with the medical device.
1051 Do not re-use Indicates a medical device that is intended for one use,
or for use on a single patient during a single
procedure.
1641 Operator's manual;
operating instructions
Indicates the need for the user to consult the
instructions for use.
0434A Caution Indicates the need for the user to consult the
instructions for use for important cautionary
information such as warnings and precautions that
cannot, for a variety of reasons, be presented on the
medical device itself.
2494 Control Indicates a control material that is intended to verify
the performance characteristics of another medical
device.
2495 Negative control Indicates a control material that is intended to verify
the results in the expected negative range.
2496 Positive control Indicates a control material that is intended to verify
the results in the expected positive range.
3083 In vitro diagnostic (IVD)
device for performance
evaluation
Indicates an IVD device that is intended to be used
only for evaluating its performance characteristics
before it is placed on the market for medical diagnostic
use.
2715 Sampling site On medical devices or blood process application: to
indicate that the device or process application includes
a system dedicated to the collection of samples of a
given substance stored in this medical device or blood
container.
STANDARD: ISO 7000—GRAPHICAL SYMBOLS FOR USE ON EQUIPMENT—REGISTERED SYMBOLS

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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.
2727 Liquid filter with pore size Indicates an infusion or transfusion system of the
medical device that contains a filter of a particular
nominal pore size.
2728 One-way valve Indicates a medical device with a valve that allows flow
in only one direction.
2610 Patient number Indicates a unique number associated with an
individual patient.
1135 General symbol for
recovery/recyclable
To indicate that the marked item or its material is part
of a recovery or recycling process.
2725 Contains or presence of On medical devices: to indicate that the equipment
contains the identified product or substance.
STANDARD: ISO 7000—GRAPHICAL SYMBOLS FOR USE ON EQUIPMENT—REGISTERED SYMBOLS

Viera™ Portable Breast Ultrasound
User Manual version 4.2.0 7
You may see some of these standard symbols on your Viera™ Portable Breast Ultrasound,
accessories, and packaging:
You may see these other symbols on your Viera™ Portable Breast Ultrasound, accessories, and
packaging:
.
OTHER STANDARDS—GRAPHICAL SYMBOLS FOR USE ON EQUIPMENT—REGISTERED SYMBOLS
Symbol Standard Reference Title Description
ISO 7010 M002 Refer to instruction
manual/booklet
Indicates to read the instruction manual/
booklet before starting work or before
operating equipment or machinery.
IEC 6417 5172 Class II equipment To identify equipment meeting the safety
requirements specified for Class II
equipment according to IEC 60536.
IEC 6417 5957 For indoor use only To identify electrical equipment designed
primarily for indoor use.
IEC 6417 5333 Type BF applied part To identify a type BF applied part
complying with IEC 60601-1.
OTHER GRAPHICAL SYMBOLS FOR USE ON EQUIPMENT
Symbol Title Description
Contains sufficient for
<n> tests
Indicates the total number of IVD tests that can be performed with
the IVD kit reagents.
In vitro diagnostic
medical device
Indicates a medical device that is intended to be used as an in vitro
diagnostic medical device.
Power connector Indicates a barrel-type power connector.
RoHS compliant Identifies electrical and electronic equipment that meets the
Restriction of Hazardous Substances (RoHS) Directive 2011/65/EU.
European Conformity Conforms to European Council Directive 93/42/EEC.
FCC Conforms to US Federal Communications Commission.
CSA certification Certified by the Canadian Standards Association. The number
below this symbol indicates the contract number.

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User Manual version 4.2.0 8
Waste Electrical and
Electronic Equipment
Requires separate collection for electrical and electronic equipment
in compliance with the Waste Electrical and Electronic Equipment
(WEEE). Directive. When accompanied by or ,
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. The backlight lamps in an LCD
system monitor contain mercury.
Ingress protection rating The equipment inside the enclosure is protected from tools and
wires greater than 2.5 millimeters, and is also protected from
immersion up to 1 meter in depth for 30 minutes.
DC Direct current.
GS1 DataMatrix Identifies GS1 encoded DataMatrix.
Global Medical Device
Nomenclature Code
A system of internationally agreed generic descriptors used to
identify all medical device products.
Global Trade Item
Number
An identifier to look up product information in a database, often by
entering the number through a bar code scanner pointed at an
actual product.
Model name Model name for the device.
Authorized
representative in the
European Community
Indicates the Authorized representative in the European
Community.
ANATEL Conforms to the Brazilian Agency of Telecommunications.
RCM Regulatory Compliance Mark for Australia and New Zealand.
NCC Conforms to Taiwan’s National Communications Commission.
OTHER GRAPHICAL SYMBOLS FOR USE ON EQUIPMENT

9
1
About the Viera™ Portable
Breast Ultrasound
Install, operate, and maintain this product according to the safety
and operating procedures in this manual, and only for its intended
purpose. Always use the information in this document with sound
clinical judgment and best clinical procedures.
This product is subject to the law in the jurisdiction that the product
is used. Install, use, and operate the product only in ways that adhere
to applicable laws or regulations, which have the force of law.
• Product package must be maintained with medical device. Do
not dispose.
• 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.
• Operating this system in the presence of flammable gases or
anesthetics can cause an explosion.
• Install and operate medical equipment according to
electromagnetic compatibility (EMC) guidelines.
• Users are responsible for image quality and diagnosis.
• This device complies with part 15 of the FCC rules. Operation is
subject to the following two conditions: (1) this device may not
cause harmful interference, and (2) this device must accept any
interference received, including interference that may cause
undesired operation.
• This product has demonstrated EMC compliance under
conditions that included the use of compliant peripheral
devices. It is important that you use compliant peripheral
devices to reduce the possibility of causing interference to
radios, televisions, and other electronic devices.

Viera™ Portable Breast Ultrasound Scanner Description
User Manual version 4.2.0 10
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™ Portable Breast Ultrasound series of wireless scanners are Bluetooth and Wi-Fi-based
scanners that communicate with a traditional tablet/smartphone via direct Wi-Fi to allow
users to export ultrasound images and display in different modes of operation. The Viera™
Portable Breast Ultrasound houses a battery and power generator, multichannel beamformer,
prescan converter and Wi-Fi components. The battery is removable and comes with a
separate charger.
Battery manufacturer Clarius
Battery model number 81-02-00001
Battery chemistry Li-ion
Battery management JEITA guideline compatible charger, in-pack fuel gauge with protection circuitry,
cell balancing, and temperature monitoring
Battery life 500 - 1000 discharge cycles before reduction in charge

Viera™ Portable Breast Ultrasound Scanner Description
User Manual version 4.2.0 11
• 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.
• Circumstances in the patient’s environment may negatively impact the scanner and the
exam. For example: (1) Chemicals and gases in the operating room. (2) Altitudes below
-382 m or above 4000 m.
• Vulnerable patients, such as children and pregnant/nursing women, may be more prone to
the exposure of acoustic energy when the scanner is used for prolonged periods.
• Biological incompatibility may exist between the scanner materials used and the biological
tissues, cells, and body fluids of the patient/user, taking account of the intended purpose
of the scanner.
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
Skin
Viera™ Portable Breast Ultrasound

Viera™ Portable Breast Ultrasound Scanner Dimensions
User Manual version 4.2.0 12
• 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. Images produced by the scanner are transmitted wirelessly to the user’s
smart device (tablet or smart phone).
Caution: Federal law restricts this device to sale by or on the order of a physician.
Unqualified/untrained personnel purchasing and using the Viera™ Portable Breast Ultrasound
may be unable to attain quality images.
Scanner Dimensions
Item Length (in/mm) Width (in/mm) Height (in/mm) Weight (oz/g)
Viera™ Portable
Breast Ultrasound
Scanner
(without battery)
3.94/100 1.66/42 6.65/169 15.4/437
Viera™ Rechargeable
Li-ion Battery
2.95/75 0.67/17 2.83/72 3.6/103
Viera™ Battery
Charger (without plug
adapter)
3.15/80 3.50/89 1.26/32 1.9/55