Vscan Air CL Overview

• Handheld, battery-powered ultrasound system for use by trained healthcare professionals.
• Designed for visualization, measurement, and guidance during diagnostic and interventional procedures.
• Dual-headed probe with a curved (convex) transducer on one end and a linear array transducer on the other.
• Works with the Vscan Air app on compatible Android™ and iOS® smartphones and tablets.
• Suitable for hospitals, clinics, medical offices, ambulances, and home or community care environments.
• Supports focused assessments and adjunctive use with other clinical data in adult, pediatric, and neonatal patients.

General System Characteristics

• 128 physical channel beamforming.
• Harmonic imaging to enhance signal-to-noise ratio and reduce side-lobe and reverberation artifacts for improved tissue detail.
• Approximate continuous scan time: 50 minutes per full battery charge (assuming ~80% B/W and 20% color imaging).
• Approximate recharge time from 10% to 90% battery: 75 minutes.
• Smart connect pairing to keep the probe associated with the display device while charging.
• Approximate probe dimensions: 131 × 64 × 31 mm.
• Approximate probe weight: 205 ± 3 g.
• Ingress protection rating: IP67.
• Drop-tested to MIL-STD-810G, Method 516.7, Table 516.7-7.
• Storage mode allows the probe to be stored for up to 36 months with limited battery degradation.

Curved Array Transducer (Deep Scanning)

• Typical applications: abdominal, fetal/obstetric, gynecological, urological, thoracic/lung, adult and pediatric cardiac (≥40 kg), peripheral vascular, musculoskeletal, pediatric, and interventional guidance (e.g., freehand needle or catheter placement, fluid drainage, nerve block, biopsy).
• Broad-band curved array with frequency range approx. 2–5 MHz (center ≈ 3.3 MHz).
• Number of elements: 128.
• Approximate lens footprint: 64 mm × 16 mm.
• Approximate viewing angle: 60°.
• Maximum imaging depth: up to 24 cm.

Linear Array Transducer (Shallow Scanning)

• Typical applications: peripheral/vascular, musculoskeletal (conventional and superficial), small parts, thoracic/lung, ophthalmic, pediatric, neonatal head, and interventional guidance (e.g., vascular access, fluid drainage, nerve block, biopsy).
• Broad-band linear array with frequency range approx. 3–12 MHz (center ≈ 7.7 MHz).
• Number of elements: 192.
• Approximate lens footprint: 40 mm × 7 mm.
• Maximum imaging depth: up to 8 cm.

Imaging Modes

• B-Mode – real-time two-dimensional grayscale imaging.
• Color Doppler – color overlay to visualize blood flow direction and presence.
• Pulsed Wave Doppler (PW) – spectral display of velocity and direction of blood flow for quantitative measurements.
• M-Mode – motion display of tissue structures along a single line over time.

User Interface & Workflow

• Thumb-optimized touchscreen interface with a minimal number of keys and gestures.
• App supports both portrait and landscape orientation to suit different scanning positions and ergonomics.
• Single key or gesture controls for:
  • Freeze / Unfreeze
  • Store image or clip
  • Gain adjustment
  • Depth adjustment
• Two-step process to change imaging preset for the selected transducer.
• Two-step process to review images from the current exam.
• Organ-specific presets with user-selectable default preset when opening the app.
• Measurement tools include distance, circumference, area, angle, velocity, slope, heart rate, bladder volume, and obstetric parameters (BPD, HC, AC, FL, CRL, AFI, DVP, AOP).
• Annotation options: arrow and free text.
• Transducer element check functionality.
• Optional centerline marker display.
• Optional TGC (Time Gain Compensation) with six depth-dependent gain controls.
• Swipe-in menu for easy access to configuration and management functions, including:
  • Enable/disable TGC controls and preview mode.
  • Enable complementary storage of binary image data.
  • Settings for auto-freeze behavior and video clip duration.
  • Configuration of the probe button (freeze or store).
  • Downloadable user manual in supported languages.
  • Diagnostics tools with log-file upload to GE HealthCare support.
  • Direct links to customer support and cloud-based educational resources.
  • Information on software versions for both probe and app, with the option to unregister or re-register the device.

Image Quality Technologies

• SignalMax™ signal-processing technology combines compact hardware with high transmit power for high-quality portable imaging.
• High-Definition Speckle Reduction Imaging (HD-SRI)* helps improve contrast resolution and smoothness while preserving important image details.
• *HD-SRI is offered as a non-standard/optional feature in some configurations.

Data Storage & Management

Patient Identification

• Manual entry of patient details at the start of the exam.
• Support for DICOM® Modality Worklist to standardize exam and image labeling before export.
• Ability to query Modality Worklist by patient ID.

Exam Storage on Device

• Capacity for approximately 500 exams on the mobile device (device-dependent).
• Still images stored in generic JPG format; video clips stored as MPG.
• Optional storage of binary image data for advanced analytics in collaboration with GE HealthCare.
• Exams organized as collections of images and clips, linked to patient information when entered.
• All stored exams can be retrieved on the device for review.

Data Export

• Ability to share anonymized images and video clips with other apps on the mobile device.
• Wireless export of images, clips, or complete exams (with or without patient information) in JPG or MP4 format to shared network folders.
• Wireless export of exams with patient data in DICOM format to DICOM PACS.
• Wireless export using DICOMweb™ (STOW-RS over TLS) to MyImageCloud¹ or other compatible third-party cloud storage.
• Supports MPPS (Modality Performed Procedure Step).

Supported DICOM Services

• Verify
• Modality Worklist
• Store
• Storage Commitment
• Secure DICOM (TLS)
• Secure DICOMweb STOW-RS (TLS)

Data Security

Security for Data at Rest

• Vscan Air app can only be opened after the mobile device itself is authenticated (e.g., device lock/unlock).
• Additional protection via app-specific user accounts and passwords.
• Support for multiple user accounts on a shared mobile device.
• Images and patient data stored in a private app space, isolated from other mobile apps.
• Images on the device are saved without embedded patient identifiers; linkage occurs via an encrypted patient database.
• Database encryption aligned with FIPS 140-2 (AES-256-bit).
• Optional extra protection with PIN or biometric access (Face ID or fingerprint) to open patient data within the app.
• Configurable security where exam data is erased after 10 incorrect PIN attempts.

Security for Data in Transit

• Images anonymized before sharing with other mobile apps.
• Support for enterprise-level Wi-Fi security including EAP and WPA2™ (PSK).
• TLS encryption with optional mutual authentication for secure DICOM transfers.
• Configurable automatic removal of images from the device after confirmed DICOM Storage Commitment.
• MyRemoteShare¹ sessions encrypted end-to-end over TLS.
• Exam and image export to MyImageCloud¹ via secure DICOMweb (STOW-RS over TLS).

Secure Authentication & SSO

• Complex password support with automatic sign-out options.
• Supports integration with enterprise Identity Providers (IdP) for Single Sign-On (SSO).
• Typical prerequisites include public-facing federation servers, firewall rules for HTTPS (e.g., port 443), and reliable internet connectivity.
• Example software options include ADFS and Azure AD Connect, with requirements for encrypted data in transit via TLS/SSL.
• Supported protocols: SAML v2 (preferred), OpenID Connect (OIDC)/OAuth 2.0 (preferred), and read-only LDAPS over secure channels.

Digital Tools & AI Features

Auto Bladder Volume¹

• AI-assisted bladder volume measurement designed to help reduce unnecessary catheterization.
• Automatically detects bladder boundaries and places measurement calipers.
• Clinician maintains control and can adjust measurements before the system calculates final volume.

MyRemoteShare²

• Enables live audio conversation with a remote participant while scanning.
• Shares the Vscan Air app screen; optional sharing of video from the mobile device camera.
• Remote participants join via a standard web browser on computer or mobile devices using a secure link.
• Powered by Zoom’s secure healthcare platform (not intended for primary diagnostic use for the remote viewer).

MyImageCloud

• Cloud-based storage and exam management for DICOM images exported from the Vscan Air app.
• Accessible via sign-in at myvscan.gehealthcare.com using the same credentials as the app.
• Allows review of uploaded exams and sharing with selected peers or colleagues.

MyDeviceHub

• Enterprise tool for managing a fleet of Vscan Air devices.
• Accessed by designated administrators through myvscan.gehealthcare.com.
• Supports device registration, user access control, and centralized configuration of DICOM servers.

Display Devices & Operating System Options

• GE HealthCare recommends using mobile devices that have been tested and validated for compatibility (listed in the Vscan Support Center).

Supported Operating Systems

• Android phones and tablets:
  • OS version 12, 13, 14 or newer.
  • 64-bit ARM CPU architecture with 64-bit kernel.
  • Minimum 4 GB RAM.
  • Android OpenGL ES 3.0 support.
  • Compatibility with Google Play™ Store.
• iPhone devices with iOS 16, 17, 18 or newer.
• iPad devices with iPadOS 16, 17, 18 or newer.

Screen & Memory Requirements

• Screen size: approx. 5–20 inches.
• Resolution: at least 960 × 640 (or 640 × 960) pixels.
• Internal storage: at least 8 GB free space.

Connectivity Requirements

• IEEE 802.11n Wi-Fi.
• Wi-Fi Direct (Android only).
• 5 GHz band support.
• Bluetooth® Low Energy 4.0.

Security Requirements for Mobile Device

• Support for WPA2™ Wi-Fi security.
• Device-level data encryption and enabled user authentication.

Standard Configuration

• Vscan Air CL probe.
• Vscan Air app (for iOS and Android)³.
• Protective carrying case.
• Wireless charger with USB cable.
• Country-specific AC adapter⁴.
• Quick Start Guide.
• Electronic user manual.

Available Accessories

• Printed user manuals in additional languages.
• Extra protective carrying case.
• Additional wireless charger with USB cable.
• trophon® Wireless Ultrasound Probe Holder¹.
• AC Adapter Multiplug¹.
• Vscan Air Roll Stand¹.

User Support & Education

Vscan Support Center

• Online hub with product information, service and clinical support resources.
• Hosts educational content such as webinars, thought-leadership pieces, and training materials.

Ultrasound Education Solutions

• Point of Care Ultrasound FocusClass by 123sonography¹ – approx. five hours of video content with demos and clinical examples covering cardiac, OB, abdominal, lung, joints, carotid, eFAST, and more.
• OB/GYN Ultrasound FocusClass by 123sonography¹ – online modules covering common obstetric and gynecologic indications, acquisition techniques, and case-based pathology examples.

Safety & Regulatory Conformance

• Probe classified as internally powered medical electrical equipment with type BF applied parts (per IEC 60601-1⁶).
• Vscan Air CL probe (model Vscan Air CL) is CE-marked under MDR (2017/745/EU), RED (2014/53/EU), RoHS (2015/863/EU), and complies with WEEE (2012/19/EU).
• Vscan Air CL models C1 and G1 are CE-marked under the Medical Device Directive (93/42/EEC), RED, RoHS, and WEEE.
• Vscan Air R3 for Android and iOS are CE-marked under MDR.
• Probe certified by NRTL to CAN/CSA-C22.2 No. 60601-1 and ANSI/AAMI ES60601-1.
• Wireless charger pad certified to IEC/EN 62368-1.

Key Safety Standards (Selection)

• IEC 60601-1 – General requirements for basic safety and essential performance.
• IEC 60601-1-2 – Electromagnetic compatibility requirements and tests (Group 1, Class B per CISPR 11 / EN 55011).
• IEC 60601-2-37 – Particular requirements for ultrasonic diagnostic and monitoring equipment.
• IEC 60601-1-11 – Home healthcare environment requirements.
• IEC 60601-1-12 – Requirements for emergency medical services environments.
• EN 13718-1 – Requirements for medical devices used in air ambulances.
• EN 1789 – Requirements for medical devices used in road ambulances.
• ISO 10993-1 and related parts – Biological evaluation of medical devices.
• IEC 62304 – Medical device software life-cycle processes.
• IEC 62366-1 – Usability engineering for medical devices.

¹ Some options, tools, or accessories may not be available in all countries or configurations.

² Remote viewing quality depends on network and device; MyRemoteShare is not intended as a primary diagnostic display for remote participants.

³ The Vscan Air app is downloaded from the App Store or Google Play and becomes a medical device after registration and activation per instructions.

⁴ One AC adapter with an appropriate plug type (e.g., A, C, F, G, or I) is included, based on region.