Clarius Ultrasound Scanner User Manual March sw ver 2.1.1 Feb 2017

Table of Contents About This Manual ... 1 Target Audience...1 Document Conventions ...2 Touch Gestures...2 Icons...3 Symbols...3

Chapter 1: About the Clarius Ultrasound Scanner ...9 Scanner Description ... 10 Scanner Dimensions... 11 Product Usage... 12 Indications for Use ...12 Contraindications ...20

Hardware... 20 Purchases & Upgrades ...20 Warranty...20 Disposal ...20

Security ... 21 Information Security...21 Network Security ...21 Confidentiality ...22 Integrity ...22 Availability...23 Accountability ...23

System Requirements... 23

Chapter 2: A Quick Tour ...25 Quick Start ... 25 Overview of the Interface... 26 Icons ...26 Menu Icons ... 26 Tools Icons ... 27

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Status Icons... 28

Menu Options...29 Support ... 29 Settings ... 30 Exams ... 31 Listen ... 32 About ... 33 Sign Out ... 34

Screen Overview...34 Sign-in Page...34 Scanners Page ...35 Workflows Page...36 Patient Demographics...37 Indications Page ...37 Imaging Page ...38 Review Page ...39 Impressions Page ...39

System Capabilities...40 Status Lights ...40 Audible Notifications ...41 Sleep Mode ...41 Auto Shutdown ...42 Scanner Locator ...42

Chapter 3: Using the Clarius Ultrasound Scanner ... 43 Downloading the Clarius App ...43 Apple iOS...43 Android™...44

Updating the Clarius Ultrasound Scanner...44 Software Updates...44 Firmware Updates ...44

Inserting & Removing the Battery ...45 Inserting the Battery...45 Removing the Battery...45

Turning the System on & off ...46 Starting the Clarius App...46 Exiting the Clarius App...46

Signing in & out...46 Signing in...46

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Clarius Ultrasound Scanner Signing out...47

Connecting Your Smart Device to a Clarius Scanner ...47 Connecting Android™ Devices to Scanners ...47 Connecting Apple iOS Devices to Scanners ...48

Managing Exams ...48 Starting New Exams...49 Pausing an Exam...50 Ending an Exam ...50 Resuming a Paused Exam...50

Managing Patient Information...51 Entering Patient Information ...51 Populating Indications...51

Selecting Scanning Modes...51 B-Mode ...51

Imaging ...52 Adjusting Gain ...52 Turning Auto-Gain on & off ...52 Manually Adjusting Gain ...53

Using the Center Line...54 Freezing/Unfreezing Cineloops ...55 Saving Cineloops & Images ...56 Cineloops ...56 Images...56

Zooming in & out ...57 Changing Depth...58 Rotating Images...58 Using the Measuring Tools ...59 Common Measuring Tools ...59 OB/GYN Measuring Tools ...60 Measurement Accuracy ...60 Measurement Accuracy Table ...61

Using the Listen Mode ...61

Review Findings...62 Reviewing Cineloops & Images ...63 Deleting Items ...63

Populating Impressions...63 Maintenance ...63 Hardware Maintenance...64 Testing Scanners ...64 Recharging Batteries ...64

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Clarius Ultrasound Scanner Storing Scanners ...65

System Maintenance ...66 Sending Activity Logs...66

Help...66 Additional Training ...66 Error Messages ...66 Need Help? ...66

Chapter 4: Cleaning & Disinfecting ... 67 Cleaning the Clarius Scanner...68 Disinfecting the Clarius Scanner...69 Intermediate Disinfection...69 High-Level Disinfection...70

Spaulding Classification ...71 Classification Guidelines ...71 Non-Critical Class...71 Semi-Critical Class ...72

Chapter 5: Safety... 73 About Diagnostic Ultrasounds...73 Interactions with Matter...73 History ...73 Studies...74 Benefits & Risks...74

Safety Topics ...75 Product Safety ...75 Product Warnings...75 Product Compatibility...76

Battery Safety ...76 Cleaning Safety ...77 Cleaners & Disinfectants...77 Scanner Care ...78

Clinical Safety ...79 Syringe Safety...79 Defibrillator Safety...79

Biological Safety ...79 Latex...79 Bioeffects...80

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Clarius Ultrasound Scanner ALARA Principle ...81 Applying ALARA...82 Using System Controls to Implement ALARA ...82 Output Display...84 Acoustics ...87

Fire & Electrical Safety ...91 Fire Safety...91 Electrical Safety...91

Electromagnetic Safety ...92 Electromagnetic Compatibility...92 Electrostatic Discharge Precautions...93 Electromagnetic Emissions...93 Electromagnetic Immunity ...94 Electromagnetic Interference ...95 Separation Distance ...95

Chapter 6: References ... 98 Compliance Statement...98 The Clarius Ultrasound Scanner ...98 Authorized Representative...98 Product Classification ...98 Product Serial Number...99 System Specifications...99 Scanner Specifications ...100

Standards...101 Acoustic ...101 Biocompatibility...101 Chemical ...101 Electrical Safety...101 Labeling...101 Quality ...102 Performance...102 Risk, Product Specification, Design Review, & Verification/Validation...102

Security & Privacy...103 Wireless...103

Acoustic Output Tables ...104 C3-45 Scanner ...104 C3-60 Scanner ...105 L7-38 Scanner...106

Control Effects Guidance Documents...107

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Disinfectants & Cleaners ...108 Compatibility Table Legend ...108 Compatible Solutions for Scanners ...108

Known Defects ...109 Glossary of Terms ...109 Acoustic Outputs...109 Acoustic Artifacts ...112

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About This Manual

To obtain a printed copy of this manual at no additional cost, contact Clarius at www.clarius.me/contact-us. This document is licensed as part of the purchase of the Clarius 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 Clarius Ultrasound Scanner: Describes the product, lists technical specifications, and its intended use. • A Quick Tour: Shows you how to get started and begin scanning. • Using the Clarius Ultrasound Scanner: Introduces you to the features and concepts, helps you set up your system, and explains the tasks you can perform. • 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 Clarius 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 You may see some of these symbols on your Clarius product, accessories, and packaging: Symbol

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Title of Symbol

Description

Manufacturer

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

Authorized representative in the European Community

Indicates the Authorized representative in the European Community.

Date of manufacture

Indicates the date when the medical device was manufactured.

Use-by date

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

Batch code

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

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Catalogue number

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

Serial number

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

Sterile

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

Sterilized using aseptic processing techniques

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

Sterilized using ethylene oxide

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

Sterilized using irradiation

Indicates a medical device that has been sterilized using irradiation.

Sterilized using steam or dry heat

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

Do not resterilize

Indicates a medical device that is not to be resterilized.

Non-sterile

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

Do not use if package is damaged

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

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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.

Fragile, handle with care

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

Keep away from sunlight

Indicates a medical device that needs protection from light sources.

Protect from heat and radioactive sources

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

Keep dry

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

Lower limit of temperature

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

Upper limit of temperature

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

Temperature limit

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

Humidity limitation

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

Atmospheric pressure limitation

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

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Biological risks

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

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.

Consult instructions for use

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

Refer to instruction manual/booklet.

Indicates to read the instruction manual/booklet before starting work or before operating equipment or machinery.

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.

Contains or presence of natural rubber latex

Indicates the presence of natural rubber or dry natural rubber latex as a material of construction within the medical device or the packaging of a medical device.

In vitro diagnostic medical device

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

Control

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

Negative control

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

Positive control

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

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Contains sufficient for <n> tests

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

For IVD performance evaluation only

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.

Sampling site

Indicates a medical device or blood processing application that includes a system dedicated to the collection of samples of a given substance stored in the medical device or blood container.

Fluid path

Indicates the presence of a fluid path.

Non-pyrogenic

Indicates a medical device that is non-pyrogenic.

Drops per millilitre

Indicates the number of drops per millilitre.

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.

One-way valve

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

Patient number

Indicates a unique number associated with an individual patient.

Type BF applied part

To identify a type BF applied part complying with IEC 60601-1.

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Class II equipment

To identify equipment meeting the safety requirements specified for Class II equipment according to IEC 60536.

For indoor use only

To identify electrical equipment designed primarily for indoor use.

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.

Recyclable material

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

Waste Electrical and Electronic Equipment

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

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.

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.

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About the Clarius Ultrasound Scanner

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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 Clarius 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 Clarius 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 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

50-02-00012

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

• Clarius App • Scanners: • C3: convex scanner, 192 elements • L7: linear scanner, 192 elements

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

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Clarius Ultrasound Scanner

Scanner Dimensions

Scanner Dimensions

Item

Length (in/mm)

Width (in/mm)

Height (in/mm)

Weight (oz/g)

Scanner (without battery, with L7 front piece)

6.7 in/169 mm

4.1 in/105 mm

1.6 in/41 mm

15.4 oz/437 g

Battery

2.8 in/70 mm

3.0 in/75 mm

0.7 in/17 mm

3.6 oz/103 g

Battery charger (without plug adapter)

3.2 in/80 mm

3.5 in/89 mm

1.3 in/32 mm

1.9 oz/55 g

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Clarius Ultrasound Scanner

Product Usage

Product Usage Indications for Use The Clarius Ultrasound Scanner is a software-based ultrasound imaging system and accessories intended for use in Point-of-Care Imaging of Medical Conditions on the general public. Point-of-Care clinical applications include: • Emergency triage exam to look at trauma conditions • Procedure guidance to guide needles into the body; and • Other targeted diagnostic and measurement applications: fetal, fetal echo, abdominal, small organ, musculo-skeletal (conventional), musculo-skeletal (superficial), urology, gynecology, cardiac adult, cardiac pediatric, peripheral vessel, pediatric, carotid • The Clarius Ultrasound Scanner is intended for use in environments where healthcare is provided by trained medical professionals. The device is not intended for use in emergency medical service, ambulance, or aircraft.

Users will be trained medical professionals (e.g., doctors, nurses, technicians). Targeted specialties shall include; Emergency Medicine, Anesthesia, Medical School Education, and Veterinary applications.1

1. Not applicable in US.

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Clarius Ultrasound Scanner

Product Usage

DEVICE NAME: CLARIUS ULTRASOUND 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

Ophthalmic

Ophthalmic

Fetal Imaging & Other

Fetal

N

Abdominal

N

M

PWD

CWD

Color Doppler

Combined (Specify)

Other*

Intra-operative (Neuro) Laparoscopic Pediatric

N

Small Organ (Thyroid, Prostate, Scrotum, Breast)

N

Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Trans-urethral Trans-esophageal (non-Cardiac) Musculo-skeletal (Conventional)

N

Musculo-skeletal (Superficial)

N

Intravascular

Cardiac

Other (Urology, Gynecology)

N

Cardiac Adult

N

Cardiac Pediatric

N

Intravascular (Cardiac) Trans-esophageal (Cardiac) Intra-cardiac

Peripheral Vessel

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Other (Fetal Echo)

N

Peripheral Vessel

N

Other (Cartoid)

N

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