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Viera Portable
User Manual
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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/terms­conditions. 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: (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
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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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™ 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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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 & 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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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
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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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 & 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
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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.
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.
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Viera™ Portable Breast Ultrasound
Document Conventions
Touch Gestures
Gesture Title of
gesture
Drag Touch the screen with a finger and move the finger across the screen without
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.
Description
lifting the 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,
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left, up, or down.
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™ 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.
STANDARD: ISO 7000 — GRAPHICAL SYMBOLS FOR USE ON EQUIPMENT — REGISTERED SYMBOLS
Symbol Reference Title Description
3082 Manufacturer Indicates the medical device manufacturer, as defined
2497 Date of manufacture Indicates the date when the medical device was
2607 Use by date Indicates the date after which the medical device is not
2492 Batch code Indicates the manufacturer's batch code so that the
in EU Directives 90/385/EEC, 93/42/EEC and 98/79/ EC.
manufactured.
to be used.
batch or lot can be identified.
2493 Catalogue number Indicates the manufacturer's catalogue number so that
2498 Serial number Indicates the manufacturer's serial number so that a
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the medical device can be identified.
specific medical device can be identified.
Viera™ Portable Breast Ultrasound
STANDARD: ISO 7000 — GRAPHICAL SYMBOLS FOR USE ON EQUIPMENT — REGISTERED SYMBOLS
2499 Sterile Indicates a medical device that has been subjected to
a sterilization process.
2500 Sterilized using aseptic
processing techniques
2501 Sterilized using ethylene
oxide
2502 Sterilized using irradiation Indicates a medical device that has been sterilized
2503 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
2606 Do not use if package is
damaged
Indicates a medical device that has been manufactured using accepted aseptic techniques.
Indicates a medical device that has been sterilized using ethylene oxide.
using irradiation.
Indicates a medical device that has been sterilized using steam or dry heat.
to a sterilization process.
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
0626 Keep away from rain Indicates a medical device that needs to be protected
0534 Lower limit of temperature Indicates the lower limit of temperature to which the
Indicates a medical device that needs protection from heat and radioactive sources.
from moisture.
medical device can be safely exposed.
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Viera™ Portable Breast Ultrasound
STANDARD: ISO 7000 — GRAPHICAL SYMBOLS FOR USE ON EQUIPMENT — REGISTERED SYMBOLS
0533 Upper limit of temperature Indicates the upper limit of temperature to which the
0632 Temperature limit Indicates the temperature limits to which the medical
0224 Measure humidity Indicates the range of humidity to which the medical
medical device can be safely exposed.
device can be safely exposed.
device can be safely exposed.
2621 Atmospheric pressure
limitation
0659 Biological risks Indicates that there are potential biological risks
1051 Do not re-use Indicates a medical device that is intended for one use,
1641 Operator's manual;
operating instructions
0434A Caution Indicates the need for the user to consult the
2494 Control Indicates a control material that is intended to verify
2495 Negative control Indicates a control material that is intended to verify
Indicates the range of atmospheric pressure to which the medical device can be safely exposed.
associated with the medical device.
or for use on a single patient during a single procedure.
Indicates the need for the user to consult the instructions for use.
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.
the performance characteristics of another medical device.
the results in the expected negative range.
2496 Positive control Indicates a control material that is intended to verify
3083 In vitro diagnostic (IVD)
2715 Sampling site On medical devices or blood process application: to
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device for performance evaluation
the results in the expected positive range.
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.
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.
Viera™ Portable Breast Ultrasound
STANDARD: ISO 7000 — GRAPHICAL SYMBOLS FOR USE ON EQUIPMENT — REGISTERED 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.
2727 Liquid filter with pore size Indicates an infusion or transfusion system of the
2728 One-way valve Indicates a medical device with a valve that allows flow
2610 Patient number Indicates a unique number associated with an
medical device that contains a filter of a particular nominal pore size.
in only one direction.
individual patient.
1135 General symbol for
recovery/recyclable
2725 Contains or presence of On medical devices: to indicate that the equipment
To indicate that the marked item or its material is part of a recovery or recycling process.
contains the identified product or substance.
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Viera™ Portable Breast Ultrasound
You may see some of these standard 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
IEC 6417 5172 Class II equipment To identify equipment meeting the safety
IEC 6417 5957 For indoor use only To identify electrical equipment designed
IEC 6417 5333 Type BF applied part To identify a type BF applied part
manual/booklet
Indicates to read the instruction manual/ booklet before starting work or before operating equipment or machinery.
requirements specified for Class II equipment according to IEC 60536.
primarily for indoor use.
complying with IEC 60601-1.
You may see these other symbols on your Viera™ Portable Breast Ultrasound, accessories, and packaging:
.
OTHER GRAPHICAL SYMBOLS FOR USE ON EQUIPMENT
Symbol Title Description
Contains sufficient for <n> tests
In vitro diagnostic medical device
Indicates the total number of IVD tests that can be performed with the IVD kit reagents.
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
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below this symbol indicates the contract number.
Viera™ Portable Breast Ultrasound
OTHER GRAPHICAL SYMBOLS FOR USE ON EQUIPMENT
Waste Electrical and Electronic Equipment
Ingress protection rating The equipment inside the enclosure is protected from tools and
DC Direct current.
GS1 DataMatrix Identifies GS1 encoded DataMatrix.
Global Medical Device Nomenclature Code
Global Trade Item Number
Model name Model name for the device.
Authorized representative in the European Community
ANATEL Conforms to the Brazilian Agency of Telecommunications.
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.
wires greater than 2.5 millimeters, and is also protected from immersion up to 1 meter in depth for 30 minutes.
A system of internationally agreed generic descriptors used to identify all medical device products.
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.
Indicates the Authorized representative in the European Community.
RCM Regulatory Compliance Mark for Australia and New Zealand.
NCC Conforms to Taiwan’s National Communications Commission.
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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.
1
• 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.
9
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™ 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,
Battery life 500 - 1000 discharge cycles before reduction in charge
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cell balancing, and temperature monitoring
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.
Viera™ Portable Breast Ultrasound
• 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.
Skin
• 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.
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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. 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)
Viera™ Rechargeable Li-ion Battery
Viera™ Battery Charger (without plug adapter)
3.94/100 1.66/42 6.65/169 15.4/437
2.95/75 0.67/17 2.83/72 3.6/103
3.15/80 3.50/89 1.26/32 1.9/55
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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-
2
neurological) vessel, carotid, and procedural guidance of needles into the body.
The system is a transportable ultrasound system intended for use in environments where healthcare is provided by trained healthcare professionals.
, pediatric, small organ, musculo-skeletal (conventional, superficial), peripheral
1
1. The following indications are specific to the Viera™ Portable Breast Ultrasound, which is within the Clar­ius Ultrasound Scanner family of scanners. For full indications for use for the Clarius Ultrasound Scanner system, please refer to the Clarius Ultrasound Scanner User Manual.
2. Intra-operative is defined as used on or inside an open wound. This indication is valid in the US only. Use in surgical environments is acceptable in all other markets.
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Viera™ Portable Breast Ultrasound Product Usage
Viera™ Scanner
DEVICE NAME: VIERA™ SCANNER
INTENDED USE: DIAGNOSTIC ULTRASOUND IMAGING OR FLUID FLOW ANALYSIS OF THE HUMAN BODY AS FOLLOWS:
Clinical Application Mode of Operation
General (Track 1 Only)
Ophthalmic Ophthalmic P
Fetal Imaging & Other
Specific (Tracks 1 & 3)
Fetal
Abdominal P P P P N B+M; B+CD;
Intra-operative (Abdominal organs & vascular)
Laparoscopic
Pediatric P P P P N B+M; B+CD;
Small Organ (Thyroid, Prostate, Scrotum, Breast)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
B M Color
Doppler
P P P P N B+M; B+CD;
P P P N B+CD; B+PD Note 1
Power Doppler
PW Doppler
Combined (Specify)
B+PD
B+PD
B+PD
Other*
Note 1
Note 1
Note 1
Trans-urethral
Trans-esophageal (non-Cardiac)
Musculo-skeletal (Conventional) P P P P N B+M; B+CD;
Musculo-skeletal (Superficial) P P P P N B+M; B+CD;
Intravascular
Other (Urology, Gynecology)
Cardiac Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esophageal (Cardiac)
Intra-cardiac
Other (specify)
Note 1
B+PD
Note 1
B+PD
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Viera™ Portable Breast Ultrasound Product Usage
DEVICE NAME: VIERA™ SCANNER
INTENDED USE: DIAGNOSTIC ULTRASOUND IMAGING OR FLUID FLOW ANALYSIS OF THE HUMAN BODY AS FOLLOWS:
Peripheral Vessel
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note 1: Needle Enhancement in B-Mode.
Peripheral Vessel P P P P N B+M; B+CD;
Other (Carotid) P P P P N B+M; B+CD;
Note 1
B+PD
Note 1
B+PD
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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 c examining tissue (for example, a mastectomy), as this could skew or alter the measured density.
• Patients whose bodies contain foreign artifacts (for example, implants), in the examining tissue.
• Ophthalmic use or any use causing the acoustic beam to pass through the eye.
• Intra-operative use (defined as introducing a scanner into a surgical incision or burr hole).
• Endocavitary use (defined as introducing a scanner within a body cavity or organ, for example, an atrium, esophagus, rectum, or vagina).
For Use in Surgical Environments
Before you use the Viera™ Portable Breast Ultrasound for intra-operative procedures or in a surgical environment, follow the instructions for high-level disinfection (for instructions see High-Level Disinfection
on page 85), then cover the Viera™ Portable Breast Ultrasound with a
sheath:
• Use only CIVCO REF 610-1212.
• Do
wnload the usage instructions from http://civco.com/mmi/ultrasound/covers/general­purpose/Latex-Free-Wireless-Ultrasound-Probe-Covers-610-1212.htm and read all the information before use.
omposition of the
When you have finished using the Viera™ Portable Breast Ultrasound, immediately clean it (for instructions see Cleaning the Viera™ Portable Breast Ultrasound on page 82), followed by another high-level disinfection.
If the sheath breaks during the intra-operative procedure, dispose same cleaning and high-level disinfecting process as above, then cover the Viera™ Portable Breast Ultrasound with a new sheath before continuing to use it.
For Use in Ophthalmic Procedures
Do not use the scanner for any use that may cause the acoustic beam to pass through the eye. Doing so may result in serious and irreversible harm to the eye of the patient.
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the sheath and follow the
Viera™ Portable Breast Ultrasound Hardware
Hardware
Warranty
Your Viera™ Portable Breast Ultrasound includes a one-year warranty. To purchase extended warranty, contact your 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.
For proper disposal of the Viera™ Portable Breast Ultrasound or any of its accessories, dispose it in accordance with local, state, and federal regulations. Alternatively, you can return it to Hologic.
The improper disposal of the Viera™ Portable Breast Ultrasound (when the battery is no longer working or the scanner has exceeded its shelf life), or any of its accessories, adds hazardous materials to our landfills.
Security
Information Security
When entering data using the Clarius App, it is your responsibility to protect your security credentials (e.g. passwords) and the personal information of patients (e.g. names).
Network Security
When connecting your smart device, use a network that supports Wi-Fi 802.11n. We recommend that you secure this network using WPA (Wi-Fi Protected Access) or WPA2 (Wi-Fi Protected Access II) as your security protocol.
For information on setting up your wireless network security, refer to your network equipment’s documentation.
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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.
For security purposes:
• Use secure passwords.
• Use secure wireless equipment using the latest firmware and software, and secure protocols.
• Lock your smart devices.
The following actions could introduce new risks to patients, operators, and third parties. It is your organization's responsibility to identify, analyze, evaluate, and control these risks:
• Changing network configurations.
• Connecting to additional networks or disconnecting from existing networks.
• Upgrading to new equipment or updating existing equipment.
Confidentiality
Confidentiality of information is assured as follows:
• The scanner contains no patient-identifying information.
• When the scanner connects to a wireless network, it encrypts and stores the Wi-Fi password.
• The data transferred between the Viera™ Portable Breast Ultrasound and the Clarius App is encrypted.
• Image data contains no patient- or user-identifying information, and is transmitted in unencrypted form. If you want this data encrypted, connect to a:
• Wi-Fi network where only trusted parties are permitted. The Wi-Fi network
• Wi-Fi Direct network. The Wi-Fi Direct network encrypts all image data, and
encrypts all image data sent from other Wi-Fi networks.
because no other users are on the Wi-Fi Direct network, the image data is confidential.
• If no images are exported to Clarius Cloud or DICOM, the Clarius App stores them in the Viera™ Portable Breast Ultrasound indefinitely. If images are exported, these images will be deleted from the device 10 days after export (you can change the default number of days to 30, 60, 90, or never).
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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.
• TCP channels used over Wi-Fi ensures that data is delivered correctly. For transmitting image data, a UDP channel is used.
Availability
If Wi-Fi connection is unattainable (e.g. Wi-Fi access points are unavailable or the network is down), use Wi-Fi Direct network, which is managed by the smart device. Because Wi-Fi Direct network is a peer-to-peer connection using the Wi-Fi protocol, it disallows other users from connecting, thereby reducing DDOS (Distributed Denial of Service) attacks.
If the Wi-Fi Direct network is disrupted, the Viera™ Portable Breast Ultrasound continues to monitor itself, and shuts down after a period of inactivity. This reduces acoustic energy transmission and battery usage.
Accountability
The concept of accountability does not apply to the Viera™ Portable Breast Ultrasound. However, ownership (i.e. the active user) of a smart device is assigned to one user at a time. Once you begin using the smart device, no other user can connect to the same smart device. All data transmitted between the smart device and the Clarius App is owned by the active user.
System Requirements
Using the Viera™ Portable Breast Ultrasound on a smart device that does not meet the minimum requirements may result in low-quality images, unexpected results, and possible misdiagnoses.
To run the Clarius App, a smart device must meet or exceed the following minimum specifications:
Technical Features:
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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:
• Dual core processor (CPU)
• ARM-based CPU architecture (for Android™-based devices)
Display:
• Resolution (in pixels) of 960x640 (or 640x960)
• Contrast ratio of 800:1
• Supports OpenGL ES 2.0
• Some sections of this User Manual may not apply to earlier versions of the Viera™ Portable Breast Ultrasound. Make sure you have the latest version of the Clarius App.
• Using a smart device that is too small may not have the necessary resolution for viewing small structures.
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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.
MENU ICONS
2
Home page. Support page.
Scanners page. Scan QR Code page.
Display menu list. Exams page.
About page. Sign out.
Clarius Cloud webpage.
Settings page.
21
Viera™ Portable Breast Ultrasound Overview of the Interface
Tools Icons
Tool icons are task buttons that perform an action when you select them.
TOOL ICONS
Discard selected item. Save image. Freeze/unfreeze a live-
scanning image. Disable auto-freeze.
Return to previous page.
Go to next page. To begin measuring,
Display search field. To create a single
Clear contents. To create a dual
Submit. To draw a
Zoom in/out of image. To draw a circle, tap
Open the tools list. To toggle auto-gain on/
Save cineloop. Display center line on
To flip the image on its axis, drag this icon left/ right or up/down.
tap this icon and select a measuring tool.
measure, tap two areas on the image
measure, tap two areas on the image to draw one line, repeat to draw second line.
circumference, drag your finger around the region of interest.
two areas on the region of interest.
off, select this icon from the tools list.
live imaging.
Disconnect active scanner and turn off its power.
Open Clarius' Facebook page.
Open Clarius' Twitter page.
Open Clarius' LinkedIn page.
Open Clarius' Instagram page.
Open Clarius' YouTube page.
Use B-Mode of imaging.
Use Needle Enhance feature.
Use Color Doppler mode of imaging.
Use M-Mode of imaging.
View image on normal speed.
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Use Power Doppler mode of imaging.
Add annotations. Reverse the colors on
View image on slow speed.
Select a pictogram from the options.
Color Doppler image.
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