GE VScan Pocket Ultrasound

Target SDGs

Market Suggested Retail Price

$8,500.00

Target Users (Target Impact Group)

Small and Medium-sized Enterprises, Public Sector Agencies

Distributors / Implementing Organizations

The VScan can be purchased through GE Healthcare or through many international distributors in new or refurbished condition.

Competitive Landscape

Direct competitors include Clarius Ultrasound, Healcerion Sonon 300C, dDopp, and GE LOGIQ V2.

Regions

Worldwide

Manufacturing/Building Method

Unknown.

Intellectural Property Type

Trademark

User Provision Model

Customers can fill out the contact form on the GE Healthcare website to request a quote. Other distributors of the product, such as Probo Medical, use similar online inquiry forms.

Distributions to Date Status

Over 15,000 VScans have been distributed across over 100 countries according to the 2014 VScan View Magazine.

Design Specifications

GE Vscan is a compact and portable diagnostic ultrasound system with integrated keyboard, fold-up LCD type display and fixed wired electronic-array transducer. The device provides black and white mode imaging for displaying anatomy. The field-of-view for the black and white imaging is up to 75 degrees with maximum depth of 24 cm. The device includes a color-coded overlay feature for real-time blood flow imaging. The device takes distance measurements and has predefined scanning settings optimized for different applications (e.g Obstetrics, Cardiac, Abdominal). The VScan includes software that is compatible with a PC operating system. The VScan can take area measurements when docked to a PC that has the Vscan gateway software installed. VScan data can be stored on a microSD or microSDHC card in jpg, mpg, or wav format.

The VScan runs on a rechargeable battery that provides up to 90 minutes of scanning (with 80% black and white, 20% color imaging). The recharge time for the device battery is one hour for 90% battery capacity. The control unit and probe may be cleaned with a warm soap and water solution and disinfected with any germicide recommended in the user manual.

Operational temperature: 10-40C; Non-operational temperature: -20-70C; Display unit: 135 x 73 x 28 mm; Probe dimensions: 120 x 33 x 26 mm; Weight (unit and probe): 390 g

Product Schematics

Technical Support

GE Healthcare provides a 3 year warranty on the product. According to the user manual, safety inspections should be performed at least every 12 months. A GE technician must perform this preventative maintenance.^{Interview with representative} Troubleshooting guidance is provided in the user manual. GE policy is that any repairs to the VScan system must be made at a warehouse. In the meantime, a loaner unit might be provided if the product is still under warranty.^{Interview with representative}

GE Healthcare provides free applications training with each system that is bought but the user should already be familiar with ultrasound scanning. Advanced applications training can be provided for new ultrasound users at an additional cost.^{Interview with representative}

The length of warranty and extent of technical service provided varies for other distributors of the product.^{Interview with distributor}

Replacement Components

Replacement components are not sold separately for VScan, partially because the product is supported with a 3 year warranty.^{Interview with representative} Accessories such as spare battery, extra docking station, or power cord are sold separately.

Lifecycle

The VScan (excluding the battery) has a lifetime of 10 years.^{Interview with representative} The battery has a lifetime of at least 300 charges.

Manufacturer Specified Performance Parameters

The distance measurement accuracy is 7% of the measured distance, for distances >1 cm. The area measurement accuracy is 10% of the measured area for areas larger than 1 cm^2.

Vetted Performance Status

The performance of the VScan has been tested and published in over 30 peer-reviewed articles. Two of these studies were conducted in Tanzania and produced positive outcomes on the training¹, ease of use, and accuracy of the Vscan². A clinical study performed in Brazil revealed that the VScan produced comparative results in visualizing the embryo heartbeat to a traditional ultrasound system for pregnant women in their first trimester³. A study performed in the United Kingdom also revealed that there was a good agreement between the VScan and high-specialization ultrasound machines for identifying the presence of fetal heart motion for women in early pregnancy⁴.

Safety

All safety precautions, such as mechanical and electrical hazards, can be reviewed in the user manual.

The lens, probe housing, and cable of the VScan must be inspected for damage and then tested for functionality before each use.

Complementary Technical Systems

Unknown.

Academic Research and References

Compliance with regulations

EMC requirements of EN55011/A1/A2:2002 Class B, IEC60601-2-37/A1/A2:2005, IEC60601-1/A1/A2:1995, IEC60601-1-1:2000, IEC60601-1-2/A1:2004, IEC60601-1-4 /A1:1999, IEC60601-1-6:2006, UL60601-1:2003, CAN/CSA C22.2 No 601.1-M90, NEMA UD3:2004, European Medical Devices Directive (MDD) 93/42/EEC as amended by 2007/47/EC (CE Mark), FDA 510(k) clearance.

Evaluation methods

The device has been evaluated for acoustic output, biocompatibility, cleaning and

disinfection effectiveness as well as thermal, electrical and mechanical safety, and has been found to conform with applicable medical device safety standards.

Other Information

GE Healthcare also sells GoldSeal refurbished VScan systems. However, the availability of refurbished Vscans is typically scarce and GoldSeal products are covered with only a one year warranty.^{Interview with representative}

The VScan was selected for inclusion in the 2013 edition of the WHO Compendium of Innovative Health Technologies for Low-Resource Settings.

Ghana's Ministry of Health has signed a Memorandum of Understanding with GE to introduce VScan in combination with a training program.

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.