Synergy MSK Ultrasound User Manual sw ver 3.1.0 Rev 5 March 2018

Disclaimer: This disclaimer extends to all printed matter accompanying the Synergy MSK Ultrasound Scanner. This manual is licensed under the Terms and Conditions available at https://www.clarius.me/ terms-conditions/. You may not use this manual except in compliance with the license. The information contained in these materials is proprietary and confidential to Clarius Mobile Health Corp. (“Clarius“) and is provided for the sole use of the individual or entity to whom it i s 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 copyright s and/or trademarks contained in these materials are the sole and exclusive property of thei r respective owners. “Clarius”, the Clarius logo, “Ultrasound Anywhere,” “Point-and-Shoot Ultrasound”, and “Act One” 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 http://www.clarius.me/patents/ for details. All names used in Clarius (whether online, in print, or any other media) are fictitious and ar e used herein for the purposes of example and demonstration on how to use the Synergy MSK Ultrasound Scanner. 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. 15-03-00035

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 Synergy MSK Ultrasound Scanner ...9 Scanner Description ... 10 Scanner Dimensions... 12 Product Usage... 12 Intended Use ...12 Indications for Use ...13 Contraindications ...14 For Use in Surgical Environments... 14

Hardware... 14 Warranty...14 Disposal ...14

Security ... 15 Information Security...15 Network Security ...15 Confidentiality ...16 Integrity ...16 Availability...16 Accountability ...17

System Requirements... 17

Chapter 2: A Quick Tour ...19 Overview of the Interface... 19 Icons ...19 Menu Icons ... 19

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Clarius Ultrasound Scanner Tools Icons ...20 Status Icons ...21

Menu Options...22 Support...22 Settings...23 Options ...23 Screen Calibration ...24 Local Storage ...24 Scanner Information ...24 Scanner Customization ...24

Exams ...25 Clarius Cast...26 About...27 Sign Out...28

Screen Overview...28 Sign-in Page...28 Scanners Page...29 Workflows Page...30 Patient Demographics ...31 Indications Page ...32 Imaging Page...32 Review Page ...33 Impressions Page ...34

System Capabilities...34 Status Lights...34 Audible Notifications ...35 Sleep Mode...35 Auto Shutdown ...36 Scanner Locator...36

Chapter 3: Using the Synergy MSK Ultrasound Scanner... 37 Downloading the Clarius App ...37 Apple iOS ...37 Android™ ...38

Updating the Synergy MSK Ultrasound Scanner ...38 Software Updates ...38 Firmware Updates...39

Inserting & Removing the Battery ...39 Inserting the Battery ...39 Removing the Battery ...39

Turning the System on & off...40

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Clarius Ultrasound Scanner Starting the Clarius App ...40 Exiting the Clarius App ...40

Signing in & out ...40 Signing in ...40 Signing out...41

Connecting Your Smart Device to a Clarius Scanner ...41 Connecting Apple iOS Devices to Scanners ...41 Connecting Android™ Devices to Scanners ...42

Managing Exams ...43 Starting New Exams...43 Pausing an Exam...44 Ending an Exam ...44 Resuming a Paused Exam...44

Managing Patient Information...45 Entering Patient Information ...45 Populating Indications...45

Selecting Scanning Modes...46 B-Mode ...46 Color Doppler ...47 Power Doppler...50 M-Mode ...50 Measuring Heart Rate...51 Measuring Time ...52

Research Mode ...52

Imaging ...53 Adjusting Gain ...53 Turning Auto-Gain on & off ...53 Manually Adjusting Gain ...55

Using the Center Line...56 Using Needle Enhance ...57 Using Automated Heart Rate...58 Freezing/Unfreezing Cineloops ...59 Capturing Cineloops & Images ...61 Saving Cineloops...61 Saving Images ...62

Zooming in & out ...63 Changing Depth...64 Rotating Images...64 Using Annotations...65 Labeling Images ...65

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Clarius Ultrasound Scanner Using Pictograms ...67

Using the Measuring Tools ...68 Common Measuring Tools ...68 Bladder Volume Measuring Tools ...69 Measurement Accuracy ...69 Measurement Accuracy Table ...69

Using the View-Sharing Mode...70 Using Chromecast™...71

Review Findings...71 Reviewing Cineloops & Images ...72 Deleting Items ...72

Populating Impressions...72 Exporting Exams ...72 Maintenance ...73 Hardware Maintenance...73 Testing Scanners ...73 Recharging Batteries ...73 Storing Scanners ...75

System Maintenance ...75 Sending Activity Logs...75

Help...75 Additional Training ...75 Error Messages ...76 Need Help? ...76

Chapter 4: Accessories ... 77 Clarius Fan...77

Chapter 5: Cleaning & Disinfecting ... 78 Cleaning...79 Cleaning the Clarius Scanner ...79 Cleaning the Clarius Fan...80

Disinfecting...80 Disinfecting the Clarius Scanner ...80 Intermediate Disinfection...81 High-Level Disinfection...82

Disinfecting the Clarius Fan ...82

Spaulding Classification ...83

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Clarius Ultrasound Scanner

Chapter 6: Safety... 84 About Diagnostic Ultrasounds...84 Interactions with Matter...84 History ...84 Studies...85 Benefits & Risks...85

Safety Topics ...86 Product Safety ...86 Product Warnings...86 Product Compatibility...87

Battery Safety ...87 Cleaning Safety ...88 Cleaners & Disinfectants...88 Minimizing the Effects of Residual Disinfectant ...88 Factors Affecting Disinfectant Efficacy ...89

Scanner Care ...89

Clinical Safety ...90 Syringe Safety...90 Defibrillator Safety...90

Biological Safety ...90 Latex...90 Bioeffects...91 Thermal ...91 Mechanical (Non-Thermal) ...91

ALARA Principle ...92 Applying ALARA...93 Using System Controls to Implement ALARA ...93 Direct Controls ...93 Indirect Controls ...94 Receiver Controls ...94 User Responsibility ...94

Output Display...95 Display Standards ...95 Display Accuracy ...96 Controls Affecting Display Indices ...97

Acoustics ...98 Acoustic Artifacts ...99 Acoustic Output & Measurement ...99 In Situ, Derated, & Water Value Intensities ...99 Conclusions Regarding Tissue Models & Equipment Survey ...100 Acoustic Measurement Precision & Uncertainty ...101

Fire & Electrical Safety ...102 Fire Safety...102 Electrical Safety...102

Electromagnetic Safety ...103

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Clarius Ultrasound Scanner Electromagnetic Compatibility...103 Electrostatic Discharge Precautions...104 Electromagnetic Emissions...104 Electromagnetic Immunity ...105 Electromagnetic Interference ...106 Separation Distance ...106 Recommended Separation Distance ...106 Avoiding Electromagnetic Interference ...107

Chapter 7: References ... 109 Compliance Statement...109 The Synergy MSK Ultrasound Scanner...109 Authorized Representative...109 Product Classification ...109 Product Serial Number...110 System Specifications...110 Scanner Specifications ...111 Clarius Scanner...111

Standards...112 Biocompatibility...112 Chemical ...112 Electrical Safety...112 Federal...112 Labeling...113 Quality ...113 Performance...113 Risk, Product Specification, Design Review, & Verification/Validation...114

Security & Privacy...115 Wireless...115

Doppler Sensitivity ...115 Acoustic Output Tables ...116 C3-45 Scanner: B-Mode & M-Mode ...116 C3-45 Scanner: Color Doppler Mode ...118 C3-60 Scanner: B-Mode & M-Mode ...120 C3-60 Scanner: Color Doppler Mode ...122 C7 Scanner: B-Mode & M-Mode...124 C7 Scanner: Color Doppler Mode...126 EC7 Scanner: B-Mode & M-Mode...128 EC7 Scanner: Color Doppler Mode...130 L7 Scanner: B-Mode & M-Mode ...132

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Clarius Ultrasound Scanner L7 Scanner: Color Doppler Mode ...134 L7 Scanner: Needle Enhance Mode...136

Control Effects Guidance Documents...138 Cleaners & Disinfectants ...138 Cleaner & Disinfectant Usage...138 Cleaner & Disinfectant Details ...139 Sterilization Systems ...139

Known Issues ...139 Glossary of Terms ...139 Acoustic Outputs...140 Acoustic Artifacts ...142

Revision History...145

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About This Manual

To obtain a printed copy of this manual at no additional cost, go to www.clarius.me/contactus and contact Clarius. This document is licensed as part of the purchase of the Synergy MSK Ultrasound Scanner and meets international regulatory requirements such as the FDA. Use of this document by unauthorized persons is strictly prohibited. This document contains the following information: • About the Synergy MSK Ultrasound Scanner: 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 Synergy MSK Ultrasound Scanner: 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 Clarius Scanner. • 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 Synergy MSK Ultrasound Scanner. It contains instructions and reference material pertaining to the usage and maintenance of the product.

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Clarius Ultrasound Scanner

Document Conventions Touch Gestures

Gesture

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Title of gesture

Description

Drag

Touch the screen with a finger and move the finger across the screen without lifting the finger.

Double tap

Touch the screen briefly twice with the same finger.

Pinch

Touch the screen with two fingers and move them toward each other.

Tap

Touch a control with your finger.

Press and hold

Touch the screen for a short time without moving your finger.

Spread

Touch the screen with two fingers and move them apart.

Swipe

Touch the screen with your finger and move the finger in a quick motion right, left, up, or down.

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Clarius Ultrasound Scanner

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 You may see some of these standard symbols on your Clarius product, accessories, and packaging:

STANDARD: ISO 7000 - GRAPHICAL SYMBOLS FOR USE ON EQUIPMENT - REGISTERED SYMBOLS Symbol

Reference

Title

Description

3082

Manufacturer

Indicates the medical device manufacturer, as defined in EU Directives 90/385/EEC, 93/42/EEC and 98/79/EC.

2497

Date of manufacture

Indicates the date when the medical device was manufactured.

2607

Use by date

Indicates the date after which the medical device is not to be used.

2492

Batch code

Indicates the manufacturer's batch code so that the batch or lot can be identified.

2493

Catalogue number

Indicates the manufacturer's catalogue number so that the medical device can be identified.

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Clarius Ultrasound Scanner STANDARD: ISO 7000 - GRAPHICAL SYMBOLS FOR USE ON EQUIPMENT - REGISTERED SYMBOLS 2498

Serial number

Indicates the manufacturer's serial number so that a specific medical device can be identified.

2499

Sterile

Indicates a medical device that has been subjected to a sterilization process.

2500

Sterilized using aseptic processing techniques

Indicates a medical device that has been manufactured using accepted aseptic techniques.

2501

Sterilized using ethylene oxide

Indicates a medical device that has been sterilized using ethylene oxide.

2502

Sterilized using irradiation

Indicates a medical device that has been sterilized using irradiation.

2503

Sterilized using steam or dry heat

Indicates a medical device that has been sterilized using steam or dry heat.

2608

Do not resterilize

Indicates a medical device that is not to be resterilized.

2609

Non-sterile

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

2606

Do not use if package is damaged

Indicates a medical device that should not be used if the package has been damaged or opened.

3084

Sterile fluid path

Indicates the presence of a sterile fluid path within the medical device in cases when other parts of the medical device, including the exterior, might not be supplied sterile.

0621

Fragile; handle with care

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

0624

Keep away from sunlight

Indicates a medical device that needs protection from light sources.

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Clarius Ultrasound Scanner STANDARD: ISO 7000 - GRAPHICAL SYMBOLS FOR USE ON EQUIPMENT - REGISTERED SYMBOLS 0615

Protect from heat and radioactive sources

Indicates a medical device that needs protection from heat and radioactive sources.

0626

Keep away from rain

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

0534

Lower limit of temperature

Indicates the lower limit of temperature to which the medical device can be safely exposed.

0533

Upper limit of temperature

Indicates the upper limit of temperature to which the medical device can be safely exposed.

0632

Temperature limit

Indicates the temperature limits to which the medical device can be safely exposed.

0224

Measure humidity

Indicates the range of humidity to which the medical device can be safely exposed.

2621

Atmospheric pressure limitation

Indicates the range of atmospheric pressure to which the medical device can be safely exposed.

0659

Biological risks

Indicates that there are potential biological risks associated with the medical device.

1051

Do not re-use

Indicates a medical device that is intended for one use, or for use on a single patient during a single procedure.

1641

Operator's manual; operating instructions

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

0434A

Caution

Indicates the need for the user to consult the instructions for use for important cautionary information such as warnings and precautions that cannot, for a variety of reasons, be presented on the medical device itself.

2494

Control

Indicates a control material that is intended to verify the performance characteristics of another medical device.

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Clarius Ultrasound Scanner STANDARD: ISO 7000 - GRAPHICAL SYMBOLS FOR USE ON EQUIPMENT - REGISTERED SYMBOLS 2495

Negative control

Indicates a control material that is intended to verify the results in the expected negative range.

2496

Positive control

Indicates a control material that is intended to verify the results in the expected positive range.

3083

In vitro diagnostic (IVD) device for performance evaluation

Indicates an IVD device that is intended to be used only for evaluating its performance characteristics before it is placed on the market for medical diagnostic use.

2715

Sampling site

On medical devices or blood process application: to indicate that the device or process application includes a system dedicated to the collection of samples of a given substance stored in this medical device or blood container.

2722

Fluid path

Indicates the presence of a fluid path.

2724

Non-pyrogenic

Indicates a medical device that is non-pyrogenic.

2726

Drops per milliliter

Indicates the number of drops per milliliter.

2727

Liquid filter with pore size

Indicates an infusion or transfusion system of the medical device that contains a filter of a particular nominal pore size.

2728

One-way valve

Indicates a medical device with a valve that allows flow in only one direction.

2610

Patient number

Indicates a unique number associated with an individual patient.

1135

General symbol for recovery/recyclable

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

2725

Contains or presence of

On medical devices: to indicate that the equipment contains the identified product or substance.

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Clarius Ultrasound Scanner

You may see some of these standard symbols on your Clarius product, 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.

You may see these other symbols on your Clarius product, accessories, and packaging:

OTHER GRAPHICAL SYMBOLS FOR USE ON EQUIPMENT Symbol

Title

Description

Contains sufficient for <n> tests

Indicates the total number of IVD tests that can be performed with the IVD kit reagents.

In vitro diagnostic medical device

Indicates a medical device that is intended to be used as an in vitro diagnostic medical device.

RoHS compliant

To identify 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.

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Clarius Ultrasound Scanner OTHER GRAPHICAL SYMBOLS FOR USE ON EQUIPMENT Waste Electrical and Electronic Equipment

Requires separate collection for electrical and electronic equipment in compliance with the Waste Electrical and Electronic Equipment (WEEE). Directive. When accompanied by

or

, components of the device may contain lead or mercury, respectively, which must be recycled or disposed of in accordance with local, state, or federal laws. The backlight lamps in an LCD system monitor contain mercury. Ingress protection rating

The equipment inside the enclosure is protected from tools and wires greater than 2.5 millimeters, and is also protected from immersion up to 1 meter in depth for 30 minutes.

Global Medical Device Nomenclature Code

A system of internationally agreed generic descriptors used to identify all medical device products.

Global Trade Item Number

An identifier to look up product information in a database, often by entering the number through a bar code scanner pointed at an actual product.

Model name

Model name for the device.

Authorized representative in the European Community

Indicates the Authorized representative in the European Community.

ANATEL

Conforms to the Brazilian Agency of Telecommunications.

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About the Synergy MSK Ultrasound Scanner

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, may relieve Clarius or its agents from all or some responsibility for resultant noncompliance, damage, or injury. • Using portable and mobile radio-frequency (RF) communications equipment can affect the operation of medical equipment. • Operating this system in the presence of flammable gases or anesthetics can cause an explosion. • Install and operate medical equipment according to electromagnetic compatibility (EMC) guidelines. • Users are responsible for image quality and diagnosis. • This device complies with part 15 of the FCC rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. • This product has demonstrated EMC compliance under conditions that included the use of compliant peripheral devices. It is important that you use compliant peripheral devices to reduce the possibility of causing interference to radios, televisions, and other electronic devices.

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Clarius Ultrasound Scanner

Scanner Description

Scanner Description The Synergy MSK Ultrasound Scanner 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 Synergy MSK Ultrasound Scanner 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 Clarius Scanner 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

99-02-00001

Battery chemistry

Li-ion

Battery management

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

Battery life

500 - 1000 discharge cycles before reduction in charge

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

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Clarius Ultrasound Scanner

Scanner Description

• Clarius App • Scanners: All scanners have 192 elements

The concept of the Synergy MSK Ultrasound Scanner and software is primarily to provide a n easy to use, high-performance, low-cost, ultrasound platform for teaching and clinical applications.

Clarius Scanner

Skin

• 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).

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