Healcerion Sonon 300C

Target SDGs

Market Suggested Retail Price

$6,000.00

Target Users (Target Impact Group)

Small and Medium-sized Enterprises, Public Sector Agencies

Distributors / Implementing Organizations

Healcerion

Competitive Landscape

Direct competitors include GE LOGIQ V2 and GE VScan Pocket Ultrasound.

Regions

Worldwide

Manufacturing/Building Method

Mass production.

Intellectural Property Type

Patent

User Provision Model

Customers can fill out the online contact form the Healcerion website to request a quote. The device can also be obtained from distributors in Europe, North America, South East Asia, and the Middle East. The Sonon 300C product is typically sold to hospitals, private doctors, NGOs, and students.^{Interview with representative}

Distributions to Date Status

More than 400 units have been distributed across over 30 countries as of August 2016.Interview with representative

Design Specifications

The SONON 300C uses a paired tablet or smartphone with the Healcerion mobile application to display ultrasound images. Images are wirelessly transmitted to the tablet or smartphone from where they can be analyzed and shared with others. The SONON 300C allows user to transmit images and recordings to the paired tablet or smartphone via Wi-Fi, 3G, or LTE networks. The mobile application can be downloaded for free from the Apple App Store or the Google Play Store. All collected images and data are stored in the mobile app and cannot be recovered if the app is removed and reinstalled.

The software enables ultrasound image capture and review, controls for time gain, dynamic range, display of mirror image, focal length, depth, brightness, contrast, linear/elliptical measurement, and image annotation, as well as storage and email transmission of images and videos. The SONON Ultrasound Imaging System allows the user to image in real time and review cine or freeze-frame images in a 2-dimensional scan format. The ultrasound imaging system also utilizes Pulsed Wave Doppler for determining the depth and location of tissue interfaces.

The Sonon 300C uses a 3.5 MHz convex array transducer that supports a max depth of 20cm and a field of view of 58.2°. The Sonon 300C has an operating time of 2.1 hours in scan mode and 12 hours in stand-by mode. The battery takes 3 hours to completely recharge. Accessories for the device (battery, back-up battery, adapter, battery charger, and power cord) are included with device.

Dimensions: 78mm x 219mm x 38mm

Weight: 390g (with battery)

Operating temperature/humidity: 0-35°C / 30% to 75% RH

Mobile device operating system and software requirements: iOS 7.0 or later, Android 4.01 or later

Minimum mobile device requirements: iPhone 5, iPad 3rd generation or later version, Galaxy S3, Galaxy Note 2, Galaxy Note 10.1 generation or later version

Product Schematics

Technical Support

Only authorized personnel shall perform any type of repair on the Sonon 300C. While it is better for users to be trained on how to interpret ultrasound images, this knowledge is not required to operate the Sonon 300C because images can be sent via Wi-Fi or mobile data for expert interpretation. It takes approximately 1-2 hours to train an individual on how to use the Sonon 300C device and mobile application. A warranty of 1-3 years is provided with the product. The duration of warranty varies depending on the situation.^{Interview with representative}

Replacement Components

Replacement parts are currently not available.^{Interview with representative}

Lifecycle

The device has an anticipated lifetime of 2-5 years.

Manufacturer Specified Performance Parameters

Unknown.

Vetted Performance Status

Unknown.

Safety

Do not use the Sonon 300C on a patient while the device is charging. Additional safety precautions are listed in the Healcerion web.

Complementary Technical Systems

Unknown.

Academic Research and References

Compliance with regulations

CE marked, FDA, KFDA (Korean Food and Drug Administration).

Evaluation methods

Non-clinical tests showed compliance with standards for electrical safety, electromagnetic compatibility, RF wireless capabilities, acoustic output levels, clinical measurement range and accuracies, display performance, usability, failure mode and risk analyses, biocompatibility, and software evaluation and cybersecurity management.

Other Information

Designers should also investigate additional guidelines, such as the WHO Manual of diagnostic ultrasound. Designers should also take social factors into consideration, such as the use of ultrasounds for gender-biased sex selection in some parts of the world.