HOLOGIC Viera Portable Breast Ultrasound User Manual Rev 5 Oct 2019

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

Hologic Technical Support USA Support Center:

(877) 371-4372 +1 (781) 999 7750 [email protected]

European Support Center:

+32 2 711 45 45 [email protected]

Australia Support Center:

1800 264 073 +61 2 9888 8000

Table of Contents About This Manual ... 1 Target Audience...1 Document Conventions ...2

Chapter 1: About the Viera™ Portable Breast Ultrasound ...5 Device Description ... 6 Scanner Dimensions... 7 Product Usage... 8 Indications for Use ...8 Contraindications ...10

Hardware... 10 Warranty...10 Disposal ...10

Security ... 11 Information Security...11 Network Security ...11 Confidentiality ...12 Integrity ...12 Availability...13 Accountability ...13

System Requirements... 13

Chapter 2: Using the Viera™ Portable Breast Ultrasound...15 Downloading the Clarius App ... 15 Turning the System on & off ... 16 Starting the Clarius App...16 Exiting the Clarius App...16

Inserting & Removing the Battery ... 16 Inserting the Viera™ Rechargeable Li-ion Battery ...16 Removing the Battery...17

A Quick Tour ... 17 Screen Overview ...17

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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

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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

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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. • 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.

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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.

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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.

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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

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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

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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.

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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

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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.

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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.

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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.

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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.

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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.

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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)

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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.

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