GE Vscan Air User manual

Technical Publications
Vscan Air
User Manual
H45611AK
GP092020-1EN - English
Rev 18
Operating Documentation
Copyright © 2022 By General Electric Co.

Regulatory requirement
Vscan Air™
This product complies with regulatory requirements of the following European
Directive 93/42/EEC concerning medical devices.
Vscan Air CL A1, Vscan Air CL A2, Vscan Air CL C1, Vscan Air CL I1 and Vscan Air
CL G1.
This manual is a reference for all 1.X software versions of Vscan Air for Android
and all 1.X software versions of Vscan Air for iOS.
Manufacturer:
GE VINGMED ULTRASOUND AS
Strandpromenaden 45
3191 Horten, Norway
Tel.: [phone] Fax: [phone]
GE, the GE Monogram, Vscan and Vscan Air are trademarks
of General Electric Company.
All other company and product names mentioned may be
trademarks of the companies with which they are associated.

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Revision History
Reason for Change
REV
DATE
DD Month YYYY REASON FOR CHANGE
Rev 1 to 11 05 Jan 2021 Internal release
Rev 12 28 Jan 2021 Initial release
Rev 13 28 Apr 2021 Country Specific Approval - Added : Importer Information for
Thailand
Chapter 1- Updated: Table 1-2: Wireless Description
Chapter 2- Added section: Thailand compliance statements
Rev 14 19 Aug 2021 Page i-6: Updated section - Country Specific Approval - Nigeria.
Chapter 2 - Updated: Caution under the section - Important
safety considerations.
Updated - Table 2-8: Label Icons - Caution symbol.
Chapter 3 - Updated section: Transient operating conditions.
Updated support center web address and Note in section: Vscan
Air -Compatible Display Devices.
Rev 15 03 Sep 2021 Chapter 1: Updated contact information - Australia and New
Zealand
Page i-6: Updated section - Country Specific Approval - Morocco
label
Rev 16 25 Nov 2021 Page i-6: Updated section - Country Specific Approval
- Indonesia: importer and license number
- Malaysia: license holder contact info and license number
Chapter 2: - Updated: Figure 2-4. Adapter label
Chapter 3:
- Figure 3-1. Vscan Air CL product box contents
- Updated Table 3-2: International AC Adapter
- Updated the section : Vscan Air App Version
- Updated Figure 3-8. Power plugs
- Updated new devices: Vscan Air - Compatible Display Devices
Rev 17 15 Feb 2022 Page i-6: Added - Authorized Swiss Representative
Chapter 1: - Updated Contact information: Table 1-7: Europe,
Middle East & Africa
Chapter 3:
- Updated new devices: Vscan Air - Compatible Display Devices
- Added information on user accounts, user sign in/sign out and
scan as guest
Chapter 4: - Added information on automatic sign out
- Added information on DICOM web server configuration
Chapter 5: Added section - Digital tools:
- MyDeviceHub
- MyImageCloud
- MyRemoteShare

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Please verify that you are using the latest revision of this document. Information
pertaining to this document is maintained on ePDM (GE electronic Product Data
Management). If you need to know the latest revision, contact your distributor, local GE
Sales Representative or in the USA call the GE Ultrasound Clinical Answer Center at
1 800 682 5327 or 1 262 524 5698.
Updated sections:
- Assign Patient data from Modality Worklist Server to the current
exam
- Assign Patient data from Modality Worklist Server to an existing
exam
- Added a section on Vscan Air emergency environment
Chapter 6: - Updated section: System care and maintenance
- Added Troubleshooting FAQs for Digital tools
- Added Password Guidelines
Rev 18 07 Sep 2022 Page i-8: Updated section - Country Specific Approval
- Korea: KC symbol and license number
- Brazil importer info
Chapter 1:
- Added section - Clinical application not cleared for use in China
Chapter 2:
- Updated Figure 2-5: Battery label
- Table 2-8: Label Icons -> added MD symbol, MR Unsafe
symbol, Assembled in Mexico, UKCA symbol
- Added Table 2-9: Telecom-, radio and wireless marking
Chapter 3
- Updated new devices: Vscan Air - Compatible Display Devices
- Added section - Delete User from application
Chapter 4:
- Added section - User account
- Updated Configuration screen with Cardiac Flip L/R feature
Chapter 5:
- Updated Table 5-1: Compatible Gels
- Updated note in section: Audit logs
- Added section - Regional instance support
Chapter 6: Added section
- Compatibility with trophon devices
- Quality assurance
- Typical Tests to Perform
- Leakage current and dielectric strength tests
- Updated Table 6-2: Chemicals compatible with the Vscan Air CL
probe
Chapter 8: Added section - Thermal index display selection
REV
DATE
DD Month YYYY REASON FOR CHANGE

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Regulatory Requirements
Conformance Standards
The GE Healthcare (GEHC) product families are tested to meet
all applicable requirements in relevant EU Directives and
European/International standards. Any changes to accessories,
peripheral units or any other part of the device must be
approved by the manufacturer. Ignoring this advice may
compromise the regulatory approvals obtained for the product.
This product complies with the regulatory requirement of the
following:
Table i-1: Regulatory requirements
Standard/Directive Scope
93/42/EEC Medical Devices Directive (MDD)
The CE label affixed to the product testifies compliance to
the Directive. The location of the CE marking is shown in the
Safety chapter of this manual.
Year of first CE mark: 2020
2014/53/EU Radio Equipment Directive (RED)
2011/65/EU
including 2015/863/EU Annex II
Directive on the restriction of the use of certain hazardous
substances in electrical and electronic equipment (ROHS)
2012/19/EU Waste Electrical and Electronic Equipment (WEEE)
EN55011 Industrial, scientific and medical equipment -
Radio-frequency disturbance characteristics - Limits and
methods of measurement
IEC* 60601-1
CAN/CSA-C22.2 No 601.1
Medical Electrical Equipment, Part 1; General Requirements
for Safety
IEC* 60601-2-37 Medical electrical equipment - Part 2-37. Particular
requirements for the safety of ultrasonic medical diagnostic
and monitoring equipment
IEC* 60601-1-2 Medical Electrical Equipment - part 1-2. Collateral standard:
Electromagnetic compatibility - Requirements and tests.
IEC* 60601-1-6 Medical Electrical Equipment - part 1-6. Collateral standard:
Usability.

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ISO10993-1 Biological evaluation of medical devices
EN 300 328 Electromagnetic compatibility and Radio spectrum Matters
(ERM); Wideband transmission systems
ISO 14971 Medical devices — Application of risk management to
medical devices
IEC* 62304 Medical device software — Software life-cycle processes
IEC* 62366-1 Medical devices — Application of usability engineering to
medical devices
IEC 60601-1-11 Requirements for medical electrical equipment and medical
electrical systems used in the home healthcare environment
IEC 60601-1-12 Requirements for medical electrical equipment and medical
electrical systems intended for use in the emergency
medical services environment
EN13718-1 Medical vehicles and their equipment — Air ambulances,
Part 1: Requirements for medical devices used in air
ambulances
EN1789 Medical vehicles and their equipment — Road ambulances
ISO15223 Medical devices — Symbols to be used with medical device
labels, labelling and information to be supplied — Part 1:
General requirements
EN1041 Information supplied by the manufacturer with medical
devices
IEC 62209-2 Human exposure to radio frequency fields from hand-held
and body-mounted wireless communication devices —
Human models, instrumentation, and procedures — Part 2:
Procedure to determine the specific absorption rate (SAR)
for wireless communication devices used in close proximity
to the human body (frequency range of 30 MHz to 6 GHz)
ISO 17664 Specifies requirements for the information to be provided by
the medical device manufacturer for the processing of a
medical device that requires cleaning followed by
disinfection and/or sterilization to ensure that the device is
safe and effective for its intended use.
This includes information for processing prior to use or reuse
of the medical device. The provisions of ISO 17664:2017 are
applicable to medical devices that are intended for invasive
or other direct or indirect patient contact.
2015/863/EU Annex II to Directive 2011/65/EU of the European
Parliament and of the Council as regards the list of restricted
substances (RoHS 3).
* including national deviations
Table i-1: Regulatory requirements (Continued)
Standard/Directive Scope

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Authorized Swiss Representative:
GE Medical Systems (Schweiz) AG
Europe-Strasse 31
8152 Glattbrugg
Switzerland
Certifications
• GE Vingmed Ultrasound AS is ISO 13485 certified.
Classifications
The following classifications are in accordance with the IEC/EN
60601-1:
Type and degree of protection against electric shock:
• The Vscan Air CL probe has an internal battery which allows
the operation during AC power absence.
• The AC adapter is Class II.
The Vscan Air CL probe is IP67 meaning that it can be
submerged in 1m of water for 30 minutes.
The AC adapter is IP20 meaning it must be limited to indoor use.
Class II equipment
Equipment in which protection against electric shock does not
rely on basic insulation only, but in which additional safety
precautions such as double insulation or reinforced insulation
are provided, there being no provision for protective earthing or
reliance upon installation conditions.

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Type BF applied part
Type BF Applied Part providing a specified degree of protection
against electric shock, with regard to allowable leakage current.
Original documentation
• The original document was written in English.
Table i-2: Leakage current
Normal condition Single fault condition
Total Patient leakage current <500 microA <1000 microA

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Country Specific Approval
Importer Information
• Turkey
Importer information for Turkey does not have the font and font
size normally used in the manual.
• Asia
Thailand
GE Medical Systems (Thailand) Ltd.
32nd Floor, Thanapoom Tower
1550 New Petchburi Road
Makkasan, Ratthewi, Bangkok 10400, Thailand
Tel: [phone]
Indonesia
Diimpor oleh PT GE Operations Indonesia, Jakarta – Indonesia
KEMENKES RI, AKL 21501124385
Malaysia
Registration Number: GB2527121-66060
GE Healthcare SDN BHD
Level 38, NU Tower 2, No: 203,
Jalan Tun Sambanthan,
50470 Kuala Lumpur, Malaysia
Tel: [phone]
Fax: [phone]

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• Brazil
Product and registration information at ANVISA
Vscan Air CL
INFORMAÇÕES DO PRODUTO E DO REGISTRO ANVISA
NOME DO PRODUTO: Equipamentos de Ultrassom
MODELO: Vscan Air CL
CONTEÚDO DA EMBALAGEM: 01 Vscan Air CL, Instrução de uso, partes e acessórios.
REGISTRO ANVISA N°: 80071260411
RESPONSÁVEL TÉCNICO: Karolina Morangoni Torres – Registro CREA/SP n° 5069785521
FABRICANTE LEGAL: GE VINGMED ULTRASOUND AS
INFORMAÇÕES DO IMPORTADOR E DISTRIBUIDOR
NOME: GE HEALTHCARE DO BRASIL COMÉRCIO E SERVIÇOS PARA
EQUIPAMENTOS MEDICOS-HOSPITALARES LTDA.
ENDEREÇO: Av. Magalhães de Castro, 4800 – Andar 10 Conj. 101 e 102, Andar
11 Conj. 111 e 112, Andar 12 Conj. 121 e 122, Torre 3 - Cidade
Jardim - CEP: 05676-120 - São Paulo/SP – Brasil
CNPJ: 00.029.372/0001-40
TELEFONE: 3004 2525 (Capitais e Regiões Metropolitanas)/ 08000 165 799
(Demais Localidades)

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Product and registration information at ANVISA (continued)
Vscan Air app
Telecom Certification Information
• Korea
• Nigeria
Connection and use of this communications equipment is
permitted by the Nigerian Communications Commission.
• Morocco
INFORMAÇÕES DO PRODUTO E DO REGISTRO ANVISA
NOME DO PRODUTO: Software
MODELO: Vscan Air app
CONTEÚDO DA EMBALAGEM: 01 Vscan Air app, Instrução de uso, partes e acessórios.
REGISTRO ANVISA N°: 80071260434
RESPONSÁVEL TÉCNICO: Karolina Morangoni Torres – Registro CREA/SP n° 5069785521
FABRICANTE LEGAL: GE VINGMED ULTRASOUND AS
INFORMAÇÕES DO IMPORTADOR E DISTRIBUIDOR
NOME: GE HEALTHCARE DO BRASIL COMÉRCIO E SERVIÇOS PARA
EQUIPAMENTOS MEDICOS-HOSPITALARES LTDA.
ENDEREÇO: Av. Magalhães de Castro, 4800 – Andar 10 Conj. 101 e 102, Andar
11 Conj. 111 e 112, Andar 12 Conj. 121 e 122, Torre 3 - Cidade
Jardim - CEP: 05676-120 - São Paulo/SP – Brasil
CNPJ: 00.029.372/0001-40
TELEFONE: 3004 2525 (Capitais e Regiões Metropolitanas)/ 08000 165 799
(Demais Localidades)

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Telecom Certification Information (continued)
• USA
FCC ID: YOM-VSCANAIR
• Canada
IC: 9136A-VSCANAIR
Steps to access FCC ID and IC ID
• To access FCC ID and IC ID information, select Menu icon on
Vscan Air app.
• Press About and select Regulatory.

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Table of Contents
Conformance Standards - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-4
Authorized Swiss Representative: - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-6
Certifications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-6
Classifications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-6
Class II equipment - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-6
Type BF applied part- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-7
Original documentation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-7
Country Specific Approval - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-8
Importer Information - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-8
Table of Contents
Chapter 1 — Introduction
Overview
Attention - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-2
Naming conventions - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-4
General description- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-4
Wireless Description - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-5
Principles of operation- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-5
Safety - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-6
Intended use - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-6
Indications for use- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-6
Contraindications for use - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-8
Intended users - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-8
Prescription Device - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-9
Warnings
Important Safety Considerations - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-10
Contact Information
Contacting GEHC Ultrasound - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-12
Manufacturer - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-18
Chapter 2 — Safety
Introduction
Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-2
Owner responsibility
Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-3
Notice against user modification- - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-3
Important safety considerations
Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-4
Patient safety - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-5
Diagnostic information- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-5
Personnel and equipment safety - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-5

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Explosion hazard - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-6
Electrical hazard - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-6
Electrical safety - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-7
External connection - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-7
Electromagnetic Compatibility (EMC) - - - - - - - - - - - - - - - - - - - - - - - - - 2-8
Electromagnetic emissions - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-13
Electromagnetic immunity - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-14
Essential Performance - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-17
Acoustic output- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-17
Environmental protection - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-23
Maximum probe temperature
Maximum probe temperature - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-24
Device labels and symbols
Vscan Air labels - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-25
For China only - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-31
Chapter 3 — Preparing Vscan Air CL for Use
Package contents
Vscan Air CL shipment box contents - - - - - - - - - - - - - - - - - - - - - - - - - 3-2
Environmental requirements
Environmental requirements for Vscan Air CL - - - - - - - - - - - - - - - - - - - 3-8
Transient operating conditions - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-8
System description
System overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-10
Display screens - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-11
Accessories
Optional accessories- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-16
Vscan Air Battery
Battery- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-17
Initial use
Pre-requisites - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-24
Power ON/OFF- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-31
Vscan Air App Version - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-32
Activation and Registration - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-32
Chapter 4 — Vscan Air Configuration (for iOS and Android)
Configuration
Configuration - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-3
User account
User account - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-44
Support
Support - Unregistered Vscan Air CL - - - - - - - - - - - - - - - - - - - - - - - - 4-46
Support - Registered Vscan Air CL- - - - - - - - - - - - - - - - - - - - - - - - - - 4-48
Diagnostics
Diagnostics - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-51
About
About- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-53

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Chapter 5 — Using Vscan Air CL
Display Features
Left panel- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-2
Scanning
General scanning recommendations- - - - - - - - - - - - - - - - - - - - - - - - - - 5-4
Measurements
Taking measurements- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-50
Review and recall of stored data
Review Current Exam - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-53
Audit logs- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-55
Export data
Share individual images/videos - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-59
Share all images/videos from an exam - - - - - - - - - - - - - - - - - - - - - - - 5-62
Export data to the DICOM Image Server- - - - - - - - - - - - - - - - - - - - - - 5-63
Secure DICOM - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-69
Export data to the Network Shared Folder- - - - - - - - - - - - - - - - - - - - - 5-74
Comprehensive exam info - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-79
Using Vscan Air in home healthcare or pre-hospital emergency medical
services environment
Configure the device for the pre-hospital emergency environment- - - - 5-82
When time is critical and charging options are limited or unavailable - - 5-83
Storing devices in between uses: - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-84
Preparing for a guided procedure with Vscan Air
Assessing Display Device Wi-Fi Performance with Vscan Air probe- - - 5-86
Digital tools
1. MyDeviceHub - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-90
2. MyRemoteShare, powered by Zoom- - - - - - - - - - - - - - - - - - - - - - - 5-96
3. MyImageCloud Solution- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-109
Chapter 6 — Vscan Air Maintenance
System care and maintenance
Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-2
Cleaning and disinfection
Reprocessing recommendation (Frequency) - - - - - - - - - - - - - - - - - - - - 6-6
Probe Reprocessing - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-9
Upgrades
Upgrade software - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-20
Vscan Air CL probe software - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-20
Connectivity troubleshooting
No connection between the Vscan Air CL and the mobile device- - - - - 6-24
Diagnostics
Diagnostics Test - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-37
Transducer Element test - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-42
Probe warning messages
Probe errors - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-43

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Chapter 7 — Privacy and Security
Introduction
Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-2
How to contact GEHC - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-2
Privacy and Security Environment Requirements- - - - - - - - - - - - - - - - - 7-3
Network Requirements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-4
Network Protocols- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-4
Network Connectivity
Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-5
Network Security - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-5
Wireless Security - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-6
Business Continuity
Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-7
Export data - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-7
Sharing images - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-7
System Protection
Vscan Air – system protection - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-8
Host OS and other host software negative compatibility - - - - - - - - - - - - 7-8
Recommendation:- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-9
Personal Information Collected by the Product
Information collection and use - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-10
Potential Hazardous Situations Resulting From Failures of the IT Network- -
7-11
Chapter 8 — Appendix
Specifications
Dimension and weight (maximum) - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-2
Curved array transducer for deep scanning - - - - - - - - - - - - - - - - - - - - - 8-2
Linear array transducer for shallow scanning- - - - - - - - - - - - - - - - - - - - 8-2
Acoustic Output
The real-time display of acoustic output indices - - - - - - - - - - - - - - - - - - 8-3
Controls Affecting Acoustic Output - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-5
Probe surface temperature safety mechanisms - - - - - - - - - - - - - - - - - - 8-6
Acoustic Parameters as Measured in Water - - - - - - - - - - - - - - - - - - - - 8-7
Acoustic Output Reporting Tables for Track 3/EN/IEC 60601-2-37 - - - - 8-9
Appendices
Statements on the safety of ultrasound - - - - - - - - - - - - - - - - - - - - - - - 8-15
Measurement accuracy
Measurement accuracy - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-16
Indications Reference Guide
Disclaimer - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-18
Curved Array (Deep scanning) Transducer - - - - - - - - - - - - - - - - - - - - 8-18
Linear Array (Shallow scanning) Transducer - - - - - - - - - - - - - - - - - - - 8-20
Index

Vscan Air – User Manual 1-1
Direction GP092020-1EN Rev 18
Chapter 1
Introduction
Contents:
‘Overview’ on page 1-2
‘Warnings’ on page 1-10
‘Contact Information’ on page 1-12

Introduction
1-2 Vscan Air – User Manual
Direction GP092020-1EN Rev 18
Overview
Attention
This manual contains necessary and sufficient information to
operate the ultrasound system safely. Read and understand all
instructions in the User Manual before attempting to use the
ultrasound system. Periodically review the procedures for
operation and safety precautions. Disregarding information on
safety is considered abnormal use. Not all features or products
described in this document may be available or cleared for sale
in all markets. Please contact your local GE representative to
get the latest information.
NOTE: Please note that orders are based on the individually agreed
upon specifications and may not contain all features listed in this
manual.
NOTE: All references to standards/regulations and their revisions are
valid at the time of publication of the user manual.
Documentation
Vscan Air documentation consists of various manuals:
• The User Manual (TRANSLATED), the quick start guide and
onboard app walkthrough provides information needed by
the user to operate the system safely. It describes the basic
functions of the system, safety features, operating modes,
measurements/calculations, transducers, Acoustic Output
and user care and maintenance.
• The Privacy and Security Manual (TRANSLATED)
describes privacy and security considerations, privacy and
security capabilities, and how they are configured and used
appropriately.
• The Service Manual (ENGLISH ONLY) supplies block
diagrams, lists of spare parts, descriptions, adjustment
instructions, or similar information which helps qualified
technical personnel in repairing those parts of the system
which have been defined as repairable.
• Medical Ultrasound Safety publication from American
Institute of Ultrasound in Medicine (AIUM) (ENGLISH
ONLY). Provided as ALARA Educational Program, to
comply with US FDA Track 3 - Not available in all countries.