Viera Portable Breast Ultrasound User Manual Rev 5 Oct 2019

Page 1

Viera™ Portable

Breast Ultrasound

User Manual

Page 2

Disclaimer:

This disclaimer extends to all printed matter accompanying the Viera™ Portable Breast

Ultrasound.

This manual is licensed under the Terms and Conditions available at www.clarius.com/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”, “Ultrasound Anywhere,” “Point-and-Shoot Ultrasound”, “Act One”, “Tri-Scanner”, “My

New Stethoscope”, “It’s About the Image”, the Clarius logo, and the Clarius Live logo 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.

© 2019 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

Page 3

Hologic Technical Support

USA Support Center:

(877) 371-4372

+1 (781) 999 7750

BreastHealth.Support@hologic.com

European Support Center:

+32 2 711 45 45

BE-Techsupport@hologic.com

Australia Support Center:

1800 264 073

+61 2 9888 8000

Page 5

Viera™ Portable Breast Ultrasound Scanner

Connecting Your Smart Device to the Viera™.........................................................20

Managing Exams .......................................................................................................21

Error Messages ...............................................................................................................21

Imaging .......................................................................................................................23

Using the Measuring Tools ..........................................................................................23

Updating the Viera™ Portable Breast Ultrasound ............................................24

Software Updates ..........................................................................................................24

Firmware Updates..........................................................................................................24

Maintenance ..............................................................................................................25

Hardware Maintenance.................................................................................................25

System Maintenance .....................................................................................................27

Chapter 3: Accessories ............................................................................. 28

Clarius Fan..................................................................................................................28

Chapter 4: Cleaning & Disinfecting .......................................................... 29

Cleaning......................................................................................................................30

Cleaning the Viera™ Portable Breast Ultrasound ..................................................30

Cleaning the Fan ............................................................................................................31

Disinfecting................................................................................................................32

Disinfecting the Viera™ Portable Breast Ultrasound ............................................32

Disinfecting the Fan ......................................................................................................33

Spaulding Classification .........................................................................................34

Chapter 5: Safety...................................................................................... 35

About Diagnostic Ultrasounds...............................................................................35

Interactions with Matter...............................................................................................35

Studies..............................................................................................................................35

Benefits & Risks..............................................................................................................36

Safety Topics .............................................................................................................36

Product Safety ................................................................................................................37

Battery Safety .................................................................................................................38

Cleaning Safety ..............................................................................................................39

Clinical Safety .................................................................................................................41

Biological Safety ............................................................................................................41

ALARA Principle ..............................................................................................................43

Fire & Electrical Safety .................................................................................................53

User Manual revision 5

ii

Page 6

Viera™ Portable Breast Ultrasound Scanner

Electromagnetic Safety ................................................................................................54

Chapter 6: References .............................................................................. 59

Compliance Statement............................................................................................59

The Viera™ Portable Breast Ultrasound ..............................................................59

Product Classification ...................................................................................................59

Product Serial Number..................................................................................................59

System Specifications...................................................................................................60

Scanner Specifications .................................................................................................61

Standards....................................................................................................................61

Biocompatibility.............................................................................................................61

Chemical ..........................................................................................................................62

Electrical Safety..............................................................................................................62

Federal..............................................................................................................................62

Labeling............................................................................................................................62

Quality ..............................................................................................................................63

Security & Privacy..........................................................................................................65

Wireless............................................................................................................................65

Doppler Sensitivity ..................................................................................................65

Acoustic Output Tables ..........................................................................................66

Viera™: B-Mode & M-Mode .........................................................................................66

Viera™: Color Doppler Mode ......................................................................................67

Viera™: Needle Enhance Mode ..................................................................................68

Cleaners & Disinfectants ........................................................................................69

Cleaner & Disinfectant Usage.....................................................................................69

Cleaner & Disinfectant Details ...................................................................................70

Sterilization Systems ....................................................................................................70

Glossary of Terms .....................................................................................................71

Acoustic Outputs............................................................................................................71

Acoustic Artifacts ...........................................................................................................74

Known Issues .............................................................................................................76

Revision History........................................................................................................76

User Manual revision 5

iii

Page 7

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.

• Using the Viera™ Portable Breast Ultrasound: Shows you how to get started and begin

scanning, introduces you to the features and concepts, and helps you set up your system.

• 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 and its

accessories.

• 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.

1

Page 8

Viera™ Portable Breast Ultrasound Scanner

Document Conventions

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 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.

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.

2609

Non-sterile

Indicates a medical device that has not been subjected to a sterilization

process.

0621

Fragile; handle with

care

Indicates a medical device that can be broken or damaged if not handled

carefully.

User Manual revision 5

2

Page 9

Viera™ Portable Breast Ultrasound Scanner

STANDARD: ISO 7000 — GRAPHICAL SYMBOLS FOR USE ON EQUIPMENT — REGISTERED SYMBOLS

0626

Keep away from rain

Indicates a medical device that needs to be protected from moisture.

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.

1641

Operator's manual;

Indicates the need for the user to consult the instructions for use.

operating instructions

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.

1135

General symbol for

recovery/recyclable

To indicate that the marked item or its material is part of a recovery or

recycling process.

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

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.

User Manual revision 5

3

Page 10

Viera™ Portable Breast Ultrasound Scanner

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

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.

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

1.0 millimeters, is dust-tight, 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.

Authorized representative in Indicates the Authorized representative in the European Community.

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.

n/a

Do not stack boxes.

n/a

Do not use knife to open.

n/a

Recycle Li-ion battery in accordance with local, state, and federal regulation

User Manual revision 5

4

Page 11

About the Viera™ Portable

Breast Ultrasound

1

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

5

Page 12

Viera™ Portable Breast Ultrasound Scanner

Device Description

devices to reduce the possibility of causing interference to radios, televisions, and other

electronic devices.

• 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.

• 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).

• Unqualified/untrained personnel purchasing and using the Viera™ Portable Breast

Ultrasound may be unable to attain quality images.

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.

Device 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 commercial off-the-shelf (COTS) 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.

User Manual revision 5

6

Page 13

Viera™ Portable Breast Ultrasound Scanner

Scanner Dimensions

Battery manufacturer

Clarius

Battery chemistry

Li-ion

Battery management

JEITA guideline compatible charger, in-pack fuel gauge with protection circuitry, cell balancing, and

temperature monitoring

Viera™ Battery Charger

life

500 discharge cycles before reduction in charge

Viera™ Battery 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

Scanner Dimensions

Item

Length (in/mm)

Width (in/mm)

Height (in/mm)

Weight (oz/g)

Viera™ Portable Breast

Ultrasound Scanner

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

3.15/80

3.50/89

1.26/32

1.9/55

User Manual revision 5

7

Page 14

Viera™ Portable Breast Ultrasound Scanner

Product Usage

Product Usage

Indications for Use1

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 (nonneurological), pediatric, small organ, musculo-skeletal (conventional, superficial), peripheral

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 professionals2 .

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. IEC 60601-1-12 is valid in North America only.

User Manual revision 5

8

Page 15

Viera™ Portable Breast Ultrasound Scanner

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)

Specific

(Tracks 1 & 3)

B M Color

Power PW

Combined (Specify)

Doppler Doppler Doppler

Ophthalmic

Ophthalmic

P

Fetal Imaging &

Other

Fetal

Other*

Abdominal

P P P

P

P

B+M; B+CD; B+PD; B+PWD Note 1

Intra-operative

(Abdominal organs & vascular)

P P P

P

P

B+M; B+CD; B+PD; B+PWD Note 1

Pediatric

P P P

P

P

B+M; B+CD; B+PD

Note 1

Small Organ

(Thyroid, Prostate, Scrotum, Breast)

P

P

P

P

B+CD; B+PD; B+PWD

Note 1

Musculo-skeletal (Conventional)

P P P

P

P

B+M; B+CD; B+PD; B+PWD Note 1

Musculo-skeletal (Superficial)

P P P

P

P

B+M; B+CD; B+PD; B+PWD Note 1

P P P

P

P

B+M; B+CD; B+PD; B+PWD Note 1

P P P

P

P

B+M; B+CD; B+PD; B+PWD Note 1

Laparoscopic

Neonatal Cephalic

Adult Cephalic

Trans-rectal

Trans-vaginal

Trans-urethral

Trans-esophageal (non-Cardiac)

Intravascular

Other (Urology, Gynecology)

Cardiac

Cardiac Adult

Cardiac Pediatric

Intravascular (Cardiac)

Trans-esophageal (Cardiac)

Intra-cardiac

Other (specify)

Peripheral Vessel Peripheral Vessel

Other (Carotid)

N = new indication; P = previously cleared by FDA

Note 1: Needle Enhancement in B-Mode.

User Manual revision 5

9

Page 16

Viera™ Portable Breast Ultrasound Scanner

Hardware

Contraindications

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 33), then cover the Viera™ Portable Breast Ultrasound with a

sheath:

• Use only CIVCO REF 610-1212, Safersonic DAN-33803-WG, and Safersonic DAN-33803-NT.

• Follow the usage instructions provided by the manufacturer.

When you have finished using the Viera™ Portable Breast Ultrasound, immediately clean it (for

instructions see Cleaning the Viera™ Portable Breast Ultrasound on page 30), followed by

another high-level disinfection.

If the sheath breaks during the intra-operative procedure, dispose the sheath and follow the

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.

Hardware

Warranty

Your Viera™ Portable Breast Ultrasound includes a one-year warranty. For full warranty details,

go to https://support.clarius.com/hc/en-us/articles/360019549672-Warranty-Coverage. 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.

User Manual revision 5

10

Page 17

Viera™ Portable Breast Ultrasound Scanner

Security

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). The user is

responsible for ensuring that patient health information is protected when using features in

the Clarius App that may expose identifying information to other viewers (e.g. Clarius Live).

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.

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.

User Manual revision 5

11

Page 18

Viera™ Portable Breast Ultrasound Scanner

Security

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

encrypts all image data sent from other Wi-Fi networks.

• Wi-Fi Direct network. The Wi-Fi Direct network encrypts all image data, and

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 by default. You can change this default in

the Clarius App’s Settings page.

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.

User Manual revision 5

12

Page 19

Viera™ Portable Breast Ultrasound Scanner

System Requirements

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:

• Supports Bluetooth LE v4.0+

• Supports Wi-Fi 802.11n and Wi-Fi Direct

• 512 MB of memory

Operating System:

• Android™ 4.4.2 (API 19)+ or Apple iOS 9.1+

Processor:

• Dual core processor (CPU)

• ARM-based CPU architecture (for Android™-based devices)

User Manual revision 5

13

Page 20

Viera™ Portable Breast Ultrasound Scanner

System Requirements

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.

User Manual revision 5

14

Page 21

Using the Viera™ Portable

Breast Ultrasound

2

This chapter explains how to install and use your Viera™ Portable

Breast Ultrasound safely and effectively.

Refer to Safety on page 35 before handling the Viera™ Portable

Breast Ultrasound.

Your Viera™ Portable Breast Ultrasound is already activated and

ready for use. You just need to download the Clarius App on an Apple

iOS device or an Android™-based device.

Downloading the Clarius App

Whether you are using Apple iOS or Android™, you must have an

account and password set up with them.

Before installing the Clarius App, make sure your smart device meets

the minimum requirements. See System Requirements on page 13.

To download the Clarius App:

1.

Go to the Apple App Store or Google Play Store.

2. Search for the Clarius App.

If you cannot find the Clarius App, your smart device may

not be meeting minimum specifications.

3. Tap the Install button and follow the instructions on your

screen.

This downloads the application.

4. Tap the Open button.

This opens the Clarius App.

15

Page 22

Viera™ Portable Breast Ultrasound Scanner

Turning the System on & off

Turning the System on & off

Starting the Clarius App

Before you begin using the Viera™ Portable Breast Ultrasound, make sure you have the

Viera™, and also your smart device with the Clarius App installed on it.

To open the Clarius App on your smart device:

Go to your smart device’s home screen and tap

.

The Clarius App opens to the sign-in screen.

Exiting the Clarius App

To close the Clarius App:

Refer to your smart device’s user manual.

Inserting & Removing the Battery

If the battery is low or empty, recharge it by following the instructions on Recharging Batteries

on page 26.

Inserting the Viera™ Rechargeable Li-ion Battery

To insert the Viera™ Rechargeable Li-ion Battery into the Viera™ Portable Breast

Ultrasound:

1.

Make sure that the battery contacts are facing downward and that the battery label is

facing the Viera™.

2. Slide the battery into the Viera™ until it locks into place.

When the battery contacts are detected, the Viera™ will emit a sound.

User Manual revision 5

16

Page 23

Viera™ Portable Breast Ultrasound Scanner

A Quick Tour

Removing the Battery

Removing the Viera™ Rechargeable Li-ion Battery

To remove the Viera™ Rechargeable Li-ion Battery from the Viera™ Portable Breast

Ultrasound:

1.

Pull back on the latch located at the top of the Viera™.

This unlocks the battery.

2. Slide the battery out of the Viera™.

A Quick Tour

Screen Overview

Sign-in Page

When you open the Clarius App, it displays a sign-in screen. To use the scanner and Clarius

App, you must have a Clarius account.

To sign in:

Open the Clarius App. It displays a sign-in screen for your user ID and password.

To sign out:

1.

Select the Sign Out menu option.

2. Select Yes.

If you want to remain signed in, select No.

User Manual revision 5

17

Page 24

Viera™ Portable Breast Ultrasound Scanner

A Quick Tour

• Create Account: This takes you to the account creation page. To create a new account,

enter your email address and then create yourself a strong password containing the

following parameters:

• At least six characters

• At least one upper case, digit, or special character

Once registered, you can go to the Clarius Cloud to add details to your account.

• Forgot Password?: This takes you to the Clarius webpage for resetting your password.

• Need Help?: This takes you to the Clarius webpage containing contact and help

information.

Scanners Page

When you sign in, the Clarius App displays the Scanners page. This page lists active scanners in

your vicinity. If your Clarius App cannot locate your scanner, either because the scanner is

powered off or because it is located outside its Bluetooth range, the scanner is grayed out on

the list.

A

beside a Viera™ Portable Breast Ultrasound indicates that you have no access to it. To

access this scanner, contact your administrator.

User Manual revision 5

18

Page 25

Viera™ Portable Breast Ultrasound Scanner

A Quick Tour

The Scanners page displays the following:

• A representative image of the scanner type.

• The currently selected scanner is displayed at the top of the list, indicated by

. Tapping

this icon disconnects the scanner from your smart device. It also turns off the scanner’s

power.

• The Bluetooth RSSI (signal strength)

.

• Custom scanner name. You can define this in the Clarius Cloud.

• Length of time since last activity.

Applications Page

Exam types are characterized as applications, a sequence of steps to complete an exam.

Applications guide you towards collecting all the information needed to produce a complete

and accurate report for the reviewing physician.

Only those exam types applicable to the selected Viera™ Portable Breast Ultrasound are

displayed in the Applications page.

User Manual revision 5

19