Clarius Ultrasound

Clarius Mobile Health

The Clarius Ultrasound is an app-based, wireless, handheld ultrasound scanner.

Snapshot
Manufacturing & delivery
Performance & use
Research & standards
Feedback

Product description Brand name and product description

The Clarius Ultrasound is an app-based, wireless, handheld ultrasound scanner. The Clarius C3 is made for performing ultrasound scans of the abdomen and lungs and also features a virtual phased array for quick scans of the heart. The other device is the Clarius L7, and Clarius L15 a procedural guidance and superficial imaging scanner.

Target region(s) Target region for distribution/implementation (listed by country if specified)

Worldwide

Distributors/implementing organizations Organization(s) distributing/deploying this product directly to communities/individuals?"

Distributed by manufacturer

Market suggested retail price Price per unit or service price per usage/terms (USD). Subsidies noted.

4,900 USD

Competitive landscape Similar products available on the market. May not be a comprehensive listing.

GE VScan, Philips Lumify, Healcieron Sonon 300C

SDG targeted United Nations Sustainable Development Goals (SDGs) targeted with this product/application/service

Goal 3: Good health and well-being

Target user(s) Target user/consumer base (country, income segment)

Trained medical professionals

Manufacturing/building method(s) Detail regarding solution production or construction method (instructions, mass production capacity, custom made,etc...)

This product is mass-produced by Clarius.

Product Intellectual Property Open source/IP protected (note patent)/trade secret/other?

Trademarked and Patented

User Provision Model Where can the product be purchased/acquired by end users?

Users can obtain the product from the Clarius Website. Clarius Scanners are also available from a network of distribution partners in parts of Europe and the Middle East. The Clarius Ultrasound App can be downloaded from the Google Play Store or Apple Store.

Distribution to date Number of units that have been deployed, downloads or users to date

Unknown

Fields marked are sourced values that have been evaluated by the manufacturer or a third party, all others are design specifications.

Power supply type

Continuous, Recharging only, None, Other

Rechargeable batteries (charger included), iPhone or Android

Consumables

Ultrasound gel. Depending on the country of purchase, the product may also include a one-time use sachet for the ultrasound gel.

Indispensable equipment for function (Y/N)

Yes

Maintenance or calibration required by user at time of use? (Y/N)

Scanning modes

B-mode, M-mode, Pulsed Wave, Power Doppler, etc.

2D, color doppler (available for certain devices), virtual phased-array

Clinical application

OB, cardiac, urology, etc…

Abdominal, lung, cardiac, procedural guidance

Display

iOS or Android device

Probe frequency (MHz)

For the C3: 2-6 MHz, for the L7: 4-13 MHz, for the L15: 5-15 MHz

Design specifications Component and Operation overview including power, portability, facility requirements, preventative maintenance and user training requirements

The Clarius ultrasound is a handheld ultrasound scanner that can operate as a standard convex array probe to image the abdomen and lungs, and a virtual phased array probe for cardiac imaging. In-detail product specifications can be found on this website.

C3 1st generation: Curvilinear Scanner

Frequency: 2 – 6 MHz
Max depth: 32 cm
Weight: 540 g

L7 1st generation: High frequency linear

Frequency: 4 – 13 MHz
Max depth: 7 cm
Weight: 540 g

L15 HD: High frequency linear

Frequency: 5 – 15 MHz
Max depth: 7 cm
Ideal for: Nerve, breast, MSK, thyroid, small parts

Product schematics Design and assembly illustrations

Unknown

Technical support Technical support provided by

Clarius provides technical support through their website. The device includes automated gain and frequency settings which eliminate the need for calibration by the user at the time of use.

Replacement components Availability of replacement components (in-country, by order,...)

Clarius provides spare or replacement components, referenced in their product terms and conditions.

Lifecycle Disposal and warranty

Three-year warranty, five-year lifetime. Disposal guidance can be obtained here.

Manufacturer specified performance targets Designer / Manufacturer specified targets

The team set out to design a low-cost portable handheld ultrasound that produces image quality comparable to that of a much more expensive device (~70,000 USD).

Vetted performance Findings of manufacturer evaluations or independent testing centers

Clinical trials and studies have been carried out including a phantom study to validate a novel 3D handheld ultrasound system in imaging scoliosis and carried out clinical trials to assess equivalency of the transabdominal Clarius handheld wifi C3 ultrasound.

Testing organizations Independent lab, academic research centers, etc.

University of Alberta, Edmonton, AB, Canada and Alberta Health Services, Edmonton, AB, Canada; Helen Pymar, Associate Professor, University of Manitoba

Safety Potential hazards / risks related to operation of this product

Instructions and warnings to use the product safely can be found on page 69 of this user manual. Several studies were carried out to ensure that the device is safe for in clinical applications.

Complementary technical systems Performance of this product is improved with another technology (eg. Cookstoves and Wind-blocking skirts)

iOS or Android device, Clarius app

Academic research Academic research related to the product (e.g. published papers in peer-reviewed journals)

Lou, E., Nguyen, D., Hill, D., & Raso, J., 2021, “Validation of a novel handheld 3D ultrasound system for imaging scoliosis–phantom study,” In Research into Spinal Deformities 9 IOS Press, pp. 100-105.

Winiker, K., et al., 2021, “Ultrasound: Reliability of a Pocket-Sized System in the Assessment of Swallowing,” Journal of Speech, Language, and Hearing Research, 64(8), pp. 2928-2940.

Moussaoui, G., Zakaria, et al., 2021, “Accuracy of Clarius, Handheld Wireless Point-of-Care Ultrasound, in Evaluating Prostate Morphology and Volume Compared to Radical Prostatectomy Specimen Weight: Is There a Difference between Transabdominal vs Transrectal Approach?,” Journal of Endourology.

Dickie, K., 2019, “Wireless ultrasound,” Clarius White Paper, pp. 1-4.

Hammond, R., 2020, “A pilot study on the validity and reliability of portable ultrasound assessment of swallowing with dysphagic patients, ” Canterbury.

Alsinan, A. Z., Patel, V. M., & Hacihaliloglu, I., 2019, “Automatic segmentation of bone surfaces from ultrasound using a filter-layer-guided CNN,” International Journal of computer-assisted radiology and surgery, 14(5), pp. 775-783.

Stuart, F., James, M., Mark, L., et al., 2009, “A New 15–50 MHz Array-Based Micro-Ultrasound Scanner for Preclinical Imaging,” Ultrasound in Medicine & Biology, Vol. 35, pp. 1700-1708.

Mawia, K., Katherine, B., Kevin, J., Kenneth, H., 2019, ‘Real-time H-scan ultrasound imaging using a Verasonics research scanner,” Ultrasonics, Vol. 94, pp. 28-36.

Compliance with regulations Product certifications and standards referenced by designer/manufacturer

Devices are FDA-cleared and the Company is ISO certified

Evaluation methods Evaluation methods/protocols/guidelines referenced by designer or manufacturer.

The device was evaluated through a phantom study, clinical trials, and other several clinical studies.

Other information

The scanner uses point-to-point Wi-Fi and Bluetooth to operate. You will need an Internet connection initially to download the Clarius App to your Android or iOS smart device and if you want to save images to the Clarius Cloud or transmit images via DICOM (available mid-2017).

To use the scanner outside an existing wireless network, select “Wi-Fi Direct” in the scanner selection page (this is the default option), and once booted, the App will prompt you to connect to the Wi-Fi Direct network of the scanner.

In context photographs (0)

You can use the form below to contribute a photo of this product.

In context files & documents (0)

Feedback from users, customers & distributors

Please let us know your experience in using this product through comments below.

Snapshot

Product description Brand name and product description

Target region(s) Target region for distribution/implementation (listed by country if specified)

Worldwide

Distributors/implementing organizations Organization(s) distributing/deploying this product directly to communities/individuals?"

Distributed by manufacturer

Market suggested retail price Price per unit or service price per usage/terms (USD). Subsidies noted.

4,900 USD

Competitive landscape Similar products available on the market. May not be a comprehensive listing.

GE VScan, Philips Lumify, Healcieron Sonon 300C

SDG targeted United Nations Sustainable Development Goals (SDGs) targeted with this product/application/service

Goal 3: Good health and well-being

Target user(s) Target user/consumer base (country, income segment)

Trained medical professionals

Manufacturing & delivery

Manufacturing/building method(s) Detail regarding solution production or construction method (instructions, mass production capacity, custom made,etc...)

This product is mass-produced by Clarius.

Product Intellectual Property Open source/IP protected (note patent)/trade secret/other?

Trademarked and Patented

User Provision Model Where can the product be purchased/acquired by end users?

Distribution to date Number of units that have been deployed, downloads or users to date

Unknown

Performance & use

Fields marked are sourced values that have been evaluated by the manufacturer or a third party, all others are design specifications.

Power supply type

Continuous, Recharging only, None, Other

Rechargeable batteries (charger included), iPhone or Android

Consumables

Ultrasound gel. Depending on the country of purchase, the product may also include a one-time use sachet for the ultrasound gel.

Indispensable equipment for function (Y/N)

Yes

Maintenance or calibration required by user at time of use? (Y/N)

Scanning modes

B-mode, M-mode, Pulsed Wave, Power Doppler, etc.

2D, color doppler (available for certain devices), virtual phased-array

Clinical application

OB, cardiac, urology, etc…

Abdominal, lung, cardiac, procedural guidance

Display

iOS or Android device

Probe frequency (MHz)

For the C3: 2-6 MHz, for the L7: 4-13 MHz, for the L15: 5-15 MHz

Design specifications Component and Operation overview including power, portability, facility requirements, preventative maintenance and user training requirements

C3 1st generation: Curvilinear Scanner

Frequency: 2 – 6 MHz
Max depth: 32 cm
Weight: 540 g

L7 1st generation: High frequency linear

Frequency: 4 – 13 MHz
Max depth: 7 cm
Weight: 540 g

L15 HD: High frequency linear

Frequency: 5 – 15 MHz
Max depth: 7 cm
Ideal for: Nerve, breast, MSK, thyroid, small parts

Product schematics Design and assembly illustrations

Unknown

Technical support Technical support provided by

Clarius provides technical support through their website. The device includes automated gain and frequency settings which eliminate the need for calibration by the user at the time of use.

Replacement components Availability of replacement components (in-country, by order,...)

Clarius provides spare or replacement components, referenced in their product terms and conditions.

Lifecycle Disposal and warranty

Three-year warranty, five-year lifetime. Disposal guidance can be obtained here.

Manufacturer specified performance targets Designer / Manufacturer specified targets

The team set out to design a low-cost portable handheld ultrasound that produces image quality comparable to that of a much more expensive device (~70,000 USD).

Vetted performance Findings of manufacturer evaluations or independent testing centers

Testing organizations Independent lab, academic research centers, etc.

University of Alberta, Edmonton, AB, Canada and Alberta Health Services, Edmonton, AB, Canada; Helen Pymar, Associate Professor, University of Manitoba

Safety Potential hazards / risks related to operation of this product

Instructions and warnings to use the product safely can be found on page 69 of this user manual. Several studies were carried out to ensure that the device is safe for in clinical applications.

Complementary technical systems Performance of this product is improved with another technology (eg. Cookstoves and Wind-blocking skirts)

iOS or Android device, Clarius app

Research & standards

Academic research Academic research related to the product (e.g. published papers in peer-reviewed journals)

Winiker, K., et al., 2021, “Ultrasound: Reliability of a Pocket-Sized System in the Assessment of Swallowing,” Journal of Speech, Language, and Hearing Research, 64(8), pp. 2928-2940.

Dickie, K., 2019, “Wireless ultrasound,” Clarius White Paper, pp. 1-4.

Hammond, R., 2020, “A pilot study on the validity and reliability of portable ultrasound assessment of swallowing with dysphagic patients, ” Canterbury.

Stuart, F., James, M., Mark, L., et al., 2009, “A New 15–50 MHz Array-Based Micro-Ultrasound Scanner for Preclinical Imaging,” Ultrasound in Medicine & Biology, Vol. 35, pp. 1700-1708.

Mawia, K., Katherine, B., Kevin, J., Kenneth, H., 2019, ‘Real-time H-scan ultrasound imaging using a Verasonics research scanner,” Ultrasonics, Vol. 94, pp. 28-36.

Compliance with regulations Product certifications and standards referenced by designer/manufacturer

Devices are FDA-cleared and the Company is ISO certified

Evaluation methods Evaluation methods/protocols/guidelines referenced by designer or manufacturer.

The device was evaluated through a phantom study, clinical trials, and other several clinical studies.

Other information

Feedback

In context photographs (0)

You can use the form below to contribute a photo of this product.

In context files & documents (0)

Feedback from users, customers & distributors

Please let us know your experience in using this product through comments below.

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In context photographs (0)

In context files & documents (0)

Feedback from users, customers & distributors