Vscan Air Product Datasheet

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GE Healthcare

Vscan Air ™
Data Sheet
Vscan Air is a battery-operated general-purpose diagnostic
ultrasound imaging system for use by qualified and trained
healthcare professionals or practitioners. It enables
ultrasound imaging guidance, visualization and measurement
of anatomical structures and fluid.
Vscan Air consists of a dual-headed probe, which integrates
both curved and linear array transducers, and an app that can
be installed on Android™ or iOS® mobile devices.
Its pocket-sized portability and simplified user interface
enables integration into training sessions and examinations in
professional healthcare facilities (ex. hospital, clinic, medical
office, home environment, road/air ambulance and in other
environments described in the product user manual).
The information can be used for basic/focused assessments
and adjunctively with other medical data for clinical diagnosis
purposes during routine, periodic follow-up, and triage
assessments for adult, pediatric and neonatal patients. Vscan
Air can also be useful for interventional guidance.
Vscan Air customers have access to the Vscan web portal,
including online access to product and product usage
information for selected clinical scenarios.
Probe Characteristics Linear array transducer for shallow scanning

128 physical channel beamforming Specific clinical applications and exam types include:
vascular/peripheral vascular, musculoskeletal
(conventional and superficial), small organs, thoracic/lung,
Black-and-white mode for displaying anatomy in real-time
ophthalmic, pediatrics, neonatal cephalic, interventional
guidance (includes free hand needle/catheter placement,
Color-coded overlay for real-time blood flow imaging fluid drainage, nerve block, vascular access and biopsy)
Harmonic imaging for increased signal-to-noise ratio Broad-bandwidth linear array: from 3 - 12 MHz with center
and reduced artifacts from side lobes, grating lobes and frequency of 7.7 MHz
reverberations, resulting in superior tissue definition and
reduced speckle artifacts. With the greater penetration Number of elements: 192
of lower ultrasound frequencies, high-quality harmonic
imaging at greater depth can be performed. Footprint: 40 mm x 7 mm (lens)

Selectable centerline marker Depth: up to 8 cm

Selectable focal zone marker

Selectable TGC control with 6 depth-dependent gain User Interface


controls The Vscan Air offers ultrasound imaging with a minimized
Total scan time of 50 minutes with fully charged battery number of keys and intuitive thumb-controllable touchscreen
user interface. The Vscan Air app supports portrait as well as
(with 80% black and white, 20% color imaging)
landscape mode to optimize image size and ergonomics for
Any Qi-compliant wireless charger can be used to different use scenarios.
charge probe
Recharge battery in 75 minutes from 10% to 90% Single key/gesture to control freeze/unfreeze, store, color
battery capacity on/off, gain and depth control

Dimensions: 131 x 64 x 31 mm 2 steps to change preset with appropriate transducer

Weight: 205 +/- 3 grams 2 steps to start reviewing images from an exam

Presets with optimized settings for imaging different


IP67 rated
organs. User-selectable default preset for immediate use
after starting the app.

Curved array transducer for deep scanning Measurements: distance, ellipse

Specific clinical applications and exam types include: Device configuration and management tools in easy reach
abdominal, fetal/obstetrics, gynecological, urology, through swiping in menu:
thoracic/lung, cardiac (adult and pediatric, 40 kg and • Enablement of TGC controls, preview mode, storage
above), vascular/peripheral vascular, musculoskeletal of binary images
(conventional), pediatrics, interventional guidance
• Setting Auto Freeze Time, video duration
(includes free hand needle/catheter placement, fluid
drainage, nerve block and biopsy) • Configuration of probe button function (Freeze or
Store)
Broad-bandwidth curved array: from 2 - 5 MHz with center
frequency of 3.3 MHz • Download user manual in selectable language to
Vscan Air app
Number of elements: 128 • Diagnostics in Vscan Air app with ability to upload
log files to GE server
Footprint: 64 mm x 16 mm (lens) • Direct access to customer support information
• Link to cloud-based educational materials
Viewing angle: 60°
• Information about software status of probe and
app with ability to un- and re-register
Depth: up to 24 cm
Data Storage Data security
Patient data identification:
Secured data at rest:
• Manual data entry of patient information for an exam • Vscan Air app starts only after confirmation of
• Select from DICOM Modality Worklist on request. mobile device protection with user authentication
Such worklist supports consistent labeling of images, • Images and other patient information data are
video clips and exams before export to DICOM PACS. stored in private space of device with no access
from other apps on mobile device
Exam data on device
• Images are stored on device without embedded
patient identification and linked with encrypted
Data for up to 500 exams can be stored on mobile device patient database
• FIPS 140-2 compliant database encryption
Data is stored in generic formats: jpg for still frames, mpg (AES-256 bit encryption)
for videos
• User selectable, additional PIN protected access to
Complementing storage of binary image data can be patient data on Vscan Air app
selected. Such data could be useful for further image
analytics in collaboration with GE.
• Wiping off exam data after 10 attempts with
incorrect PIN
Data is organized as individual examinations with
collection of images and can be linked with patient Secured data on the move:
identification • Images are anonymized before being shared with
other apps on the mobile device
All stored data can be recalled for review
• Support of enterprise-grade wireless encryption
standards including EAP and WPA2 (PSK)
Data export • TLS encryption with optional peer authentication to
support secure DICOM transfer
Anonymized images and videos can be shared with other
• Configurable time period for image removal on the
apps available on smart device
device after export to a DICOM PACS server
Images, video clips or exams with or without patient
information can be wirelessly exported in generic formats
(jpg, mp4) to shared network folders
Images, video clips or exams with patient information can Standard Configuration
be wirelessly exported in DICOM format to DICOM PACS The following items are included in the standard
Vscan Air offering:
Supported DICOM services
Vscan Air CL probe
Verify
Vscan Air app(Vscan Air for iOS and Vscan Air for Android)i
Modality Worklist
Protective carrying case
Store
Hardcopy Quick Start Guide
Storage Commitment
Electronic Instruction Use Guide
Secure DICOM (TLS)
Wireless charger pad including micro USB cable

Country-specific AC adapter ii
Available Accessories User Support Tools
Hardcopy user manual in different languages Vscan family web portal

Online services to enhance the Vscan Air experience by


Additional protective carrying case
providing resources, from product information to clinical
and service support
Additional wireless charger pad
Additional educational resources will be posted on the
International AC adapters ii Vscan web portal, including webinars, thought leadership,
further online programs and training opportunities

Ultrasound education solutionsiv


Supported Mobile Platformsiii To help users get familiar with common point-of-care
applications and improve ultrasound skills and knowledge,
Operating system options two digital education solutions are available via our partners.

Android phones and tablets with OS version 9, 10 or 11, Point of Care Ultrasound FocusClass by
device with 0x64 ARM based CPU architecture and 64-bit 123 Sonography
Kernel, Android open GL ES 3.0, and compatibility with • This course includes access to five hours of
Google Play™ store high-quality video content, easy-to-follow
iPad and iPhone devices with iOS 13 or 14 hands-on demos, practical clinical examples
and proven didactive principles to help increase
competence and confidence. This program is
Screen requirements
designed for primary care covering a variety of
ultrasound exam types including cardiac, OB,
Size: from 5 to 20 inches
abdominal, lung and joints
960 x 640 (or 640 x 960) pixel or more SonoSim® 365 for GE Healthcare
• SonoSim 365 for GE Healthcare provides convenient
Internal memory requirements ultrasound education through integrated didactic
instruction, hands-on training, and knowledge
8GB or more assessment. A portable, virtual ultrasound training
experience utilizing real patient cases with a broad
spectrum of normal and pathologic conditions.
Connectivity requirements
This offering includes a SonoSim probe, SonoSim
IEEE 802.11n drive, and your choice of five modules immediately
accessible online – choose from a wide selection of
Peer-to-peer connectivity (Android only) modules including anatomy, physiology, and clinical
procedures.
Bluetooth BLE 4.0

Security requirements

WPA2™

Data on device must be encrypted and authentication enabled

Verified/ Validated mobile devices


The list of the verified and validated mobile devices can found
on Vscan family web portal.
Safety Conformance Vscan Air conforms to applicable clauses of the following
safety standards:

Safety classification IEC 60601-1vi Medical electrical equipment –


Part 1: General requirements for basic
Vscan Air CL probe is classified as internally powered safety and essential performance
medical electrical equipment with type BF applied parts
according to IEC 60601-1v IEC 60601-1-2iv Medical electrical equipment –
Vscan Air CL probe is CE-marked according to MDD Part 1-2: General requirements for basic
(93/43/EEC), RED (2014/53/EU), RoHS (2011/65/EU), and is safety and essential performance –
compliant to 2012/19/EU (WEEE) Collateral Standard: Electromagnetic
disturbances – Requirements and tests.
Vscan Air for Android and Vscan Air for iOS are CE-marked (Group One, Class B per CISPR 11 / EN
according to MDD (93/42/EEC) 55011)
Vscan Air CL probe is NRTL Certified to CAN/CSA-C22.2 IEC 60601-2-37 Medical electrical equipment –
No. 60601-1 and ANSI/AAMI ES60601-1. Part 2-37: Particular requirements
Wireless charger pad of Vscan Air is certified according to for the basic safety and essential
IEC/EN62368-1 and/or IEC/UL/cUL60950-1 performance of ultrasonic medical
diagnostic and monitoring equipment
IEC 60601-1-11 Medical electrical equipment –
Part 1-11: General requirements for
basic safety and essential performance –
Collateral Standard: Requirements
for medical electrical equipment and
medical electrical systems used in the
home healthcare environment
IEC 60601-1-12 Medical electrical equipment –
Part 1-12: General requirements for
basic safety and essential performance –
Collateral Standard: Requirements
for medical electrical equipment and
medical electrical systems intended for
use in the emergency medical services
environment
EN 13718-1 Medical vehicles and their equipment –
Air ambulances
Part 1: Requirements for medical devices
used in air ambulances
EN 1789 Medical vehicles and their equipment –
Road ambulances
ISO 10993-1vii Biological evaluation of medical devices
Part 1: Evaluation and testing within a
risk management process
IEC62304 Medical device software – Software life
cycle processes.

IEC62366-1 Medical devices – Part 1: Application of


usability engineering to medical devices
i
The Vscan Air app can be downloaded via App Store or Google Play, accordingly. It converts after confirmed by e-mail registration
into a medical device. Before converting, it can be used for preview purposes as non-medical device.
In accordance to IEC classification for power plugs, one AC adapter with either an A, C, G, or I connector will be part of standard
ii

configuration.
Using the Vscan Air app with a mobile device which does not meet the minimum requirements may result in low-quality images,
iii

unexpected results and possible misdiagnosis. The Vscan Air app may not work in all devices. A recommended step in testing a
particular device compatibility is the download, installation and first use of the Vscan Air app in preview mode.
iv
Not available in every country
v
When not charging using the wireless charger.
vi
Including national deviations.
vii
Includes compliance to relevant sub-parts of ISO 10993 as per the intended use of Vscan Air.

© 2020 General Electric Company – All rights reserved.


GE Healthcare reserves the right to make changes in specifications and features shown herein, or discontinue the product
described at any time without notice or obligation. Contact your GE Healthcare representative for the most current information.
GE, the GE Monogram, imagination at work, Vscan Air and Vscan are trademarks of General Electric Company. GE Healthcare,
a division of General Electric Company. Google, Android and Google Play are registered trademarks of Google LLC. DICOM is
the registered trademark of the National Electrical Manufacturers Association for its standards publications relating to digital
communications of medical information. App Store is a trademark of Apple Inc., registered in the U.S. and other countries. IOS is
a trademark or registered trademark of Cisco in the U.S. and other countries and is used under license. The Bluetooth word mark
and logos are registered trademarks owned by Bluetooth SIG, Inc. WPA and WPA2 are registered trademarks of Wi-Fi Alliance.
SonoSim is a registered trademark of SonoSim, Inc.
GE Medical Systems, Inc., doing business as GE Healthcare.

January 2021
DOC2229649

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