Vscan Air User Manual Rev 08

Regulatory requirement Vscan Air™ The Vscan Air R2 for iOS and Vscan Air R2 for Android product with their connected probes complies with regulatory requirements of the following European Directive 2017/745/EU Medical Device Regulation

This manual is a reference for the following Vscan Air CL probe configurations: 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 the Vscan Air SL probe configurations: Vscan Air SL This manual is a reference for all 2.X software versions of Vscan Air R2 for Android and all 2.X software versions of Vscan Air R2 for iOS.

Manufacturer: GE VINGMED ULTRASOUND AS Strandpromenaden 45 3191 Horten, Norway Tel.: (+47) 3302 1100 Vscan, Vscan Air and XDclear are trademarks of GE HealthCare. GE is a trademark of General Electric Company used under trademark license. All other company and product names mentioned may be trademarks of the companies with which they are associated.

Revision History Reason for Change

REV

DATE DD Month YYYY

REASON FOR CHANGE

Rev 1 to 4

25 Apr 2023

Internal release

Rev 5

13 Jun 2023

Initial release

Rev 6

17 Aug 2023

Chapter 2: - Added Radio Frequency info under section - Interference Caution - Updated Table 2-2: Electromagnetic immunity (Part 1) Chapter 6: - Updated Step 2 in Table 6-5: Troubleshooting in pairing

Rev 7

20 Oct 2023

Chapter 3: - Updated Section Vscan Air - Compatible Display Devices Chapter 4: - Added Storage Mode information under Section Configuration - Updated Figure 4-67. Probe subscription details and Figure 4-68. Subscribed Digital tools available - Added Sections Subscription Auto renewal and Subscription Expiry Date Chapter 5: - Added Figure 5-7. Flat Linear Array (FLA) - Added Section Image crop and measurements - Added Angle measurement information - Added Figure 5-65. Select Angle measurement - Updated Section Storing devices in between uses Chapter 6: - Added Section Postpone update - Updated Section Upgrade software

Rev 8

27 Feb 2024

- Added Oman and South Africa Telecom Certification Information for Vscan Air CL - Added Oman, Korea, South Africa, Nigeria, and Morocco Telecom Certification Information for Vscan Air SL - Updated the 5GHz preferred bandwidth to 20MHz in the section ‘Wireless description for Vscan Air probes’.

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.

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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, EU regulations 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: Standard/Directive

Regulatory requirements Scope

2017/745 Medical Device Regulation (MDR)

Medical Device Regulation (MDR). The CE label affixed to the product testifies compliance to this regulation. The location of the CE marking is shown in the Safety chapter of this manual. Year of first CE mark: 2023

93/42/EEC Medical Devices Directive (MDD)

Medical Devices Directive (MDD) The CE label affixed to the Vscan Air CL A1, Vscan Air CL A2, Vscan Air CL C1, Vscan Air CL I1 and Vscan Air CL G1 probes 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

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Table i-1: Standard/Directive

Regulatory requirements (Continued) Scope

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.

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)

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Table i-1:

Regulatory requirements (Continued)

Standard/Directive

Scope

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

NOTE:

All references to standards/regulations and their revisions are valid at the time of publication of the user manual.

Authorized Swiss Representative: GE Medical Systems (Schweiz) AG Europa-Strasse 31 8152 Glattbrugg Switzerland

Certifications •

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GE Vingmed Ultrasound AS is ISO 13485 certified.

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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 and Vscan Air SL probes has an internal battery which allows the operation during AC power absence.

•

The AC adapters available with Vscan Air are Class II devices.

•

The AC adapters available with Vscan Air must be limited to indoor use only.

The Vscan Air CL and Vscan Air SL probes are labeled 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.

Type BF applied part Type BF applied part providing a specified degree of protection against electric shock, with regard to allowable leakage current. Table i-2:

Leakage current

Normal condition Total Patient leakage current

<500 microA

Single fault condition <1000 microA

Original documentation •

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The original document was written in English.

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Country Specific Approval Importer Information • Turkey NOTE:

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: (+66) 2 624 8488

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Telecom Certification Information for Vscan Air CL • Korea

• Nigeria

Connection and use of this communications equipment is permitted by the Nigerian Communications Commission.

• Morocco

• 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.

• Oman

• South Africa

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Telecom Certification Information for Vscan Air SL • Korea

• Nigeria

Connection and use of this communications equipment is permitted by the Nigerian Communications Commission.

• Morocco

• USA

FCC ID: YOM-VSCANAIRSL 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.

• Oman

• South Africa

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Table of Contents

Conformance Standards - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-3 Authorized Swiss Representative: - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-5 Certifications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-5 Classifications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-6 Class II equipment - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-6 Type BF applied part- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-6 Original documentation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-6 Country Specific Approval - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-7 Importer Information - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-7

Table of Contents Chapter 1 - Introduction Overview Attention - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-2 Naming conventions - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-5 General description- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-5 Wireless description for Vscan Air probes - - - - - - - - - - - - - - - - - - - - - - 1-6 Principles of operation- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-7 Safety - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-7 Intended use - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-7 Indications for use- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-8 Clinical benefit - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-10 Contraindications for use - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-10 Reporting - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-10 Intended users - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-11 Prescription Device - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-12 SignalMax and XDclear - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-12

Warnings Important safety considerations - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-13

Contact information Contacting GEHC Ultrasound - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-15 Manufacturer - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-21

Chapter 2 - Safety Introduction

Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-2

Owner responsibility Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-4 Notice against user modification- - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-5

Important safety considerations Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-6

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Patient safety - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-7 Diagnostic information- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-7 Personnel and equipment safety - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-8 Explosion hazard - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-8 Electrical hazard - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-8 Electrical safety - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-9 External connection - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-9 Electromagnetic Compatibility (EMC) - - - - - - - - - - - - - - - - - - - - - - - - 2-10 Electromagnetic emissions - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-16 Electromagnetic immunity - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-17 Essential Performance - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-19 Acoustic output- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-19 Environmental protection - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-25

Maximum probe temperature Maximum probe temperature - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-26

Device labels and symbols Vscan Air labels - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-27 For China only - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-33

Chapter 3 - Preparing Vscan Air for Use Package contents

Vscan Air shipment box contents - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-2

Environmental requirements Environmental requirements for Vscan Air probe - - - - - - - - - - - - - - - - - 3-7 Transient operating conditions - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-7

System description System overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-9 Display screens - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-10

Accessories Optional accessories- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-16

Vscan Air battery

Battery- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-20

Initial use Pre-requisites - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-27 Power ON/OFF- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-36 Vscan Air App Version - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-38 Activation and Registration - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-38

Chapter 4 - Vscan Air Configuration (for iOS and Android) Configuration

Configuration - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-3

User account User account - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-50

Support Support - Vscan Air probe not registered- - - - - - - - - - - - - - - - - - - - - - 4-51 Support - Registered Vscan Air probe- - - - - - - - - - - - - - - - - - - - - - - - 4-52

Diagnostics Diagnostics - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-54

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About About- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-57

Chapter 5 - Using Vscan Air Display features

Left panel- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-2

Scanning General scanning recommendations- - - - - - - - - - - - - - - - - - - - - - - - - - 5-5

Measurements Taking measurements- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-77 OB (Obstetric) measurement - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-80

Annotations Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-90

Review and recall of stored data Review Current Exam - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-100 Audit logs- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-102

Export data Share individual images/videos - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-106 Share all images/videos from an exam - - - - - - - - - - - - - - - - - - - - - - 5-109 Export data to the DICOM Image Server - - - - - - - - - - - - - - - - - - - - - 5-110 Secure DICOM - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-116 Export data to the Network Shared Folder- - - - - - - - - - - - - - - - - - - - 5-121 Comprehensive exam info - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-126

Using Vscan Air Using Vscan Air in environments where time is critical and disruptions are less tolerated - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-128 Configure the device for acute- and emergency environments - - - - - 5-129 When time is critical and charging options are limited or unavailable - 5-130 Scanning for foreign bodies - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-131 Storing devices in between uses - - - - - - - - - - - - - - - - - - - - - - - - - - 5-132

Preparing for a guided procedure with Vscan Air Assessing Display Device Wi-Fi Performance with Vscan Air probe- - 5-137

Digital tools 1. MyDeviceHub - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-141 2. MyRemoteShare, powered by Zoom - - - - - - - - - - - - - - - - - - - - - - 5-147 3. MyImageCloud Solution- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-160

Chapter 6 - Vscan Air Maintenance System care and maintenance

Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-2

Cleaning and disinfection Reprocessing recommendation (Frequency) - - - - - - - - - - - - - - - - - - - - 6-6 Probe Reprocessing - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-8

Upgrades Upgrade software - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-20 Vscan Air probe software upgrade - - - - - - - - - - - - - - - - - - - - - - - - - - 6-21 Postpone update - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-25

Troubleshooting No connection between the Vscan Air probe and the mobile device- - - 6-26

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Diagnostics Diagnostics Test - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-42 Transducer Element test - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-47

Probe warning messages Probe errors - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-52

Chapter 7 - Appendix Specifications

Vscan Air probe Dimension and weight (maximum) - - - - - - - - - - - - - - - 7-2 Vscan Air CL and SL transducers- - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-2

Acoustic output The real-time display of acoustic output indices - - - - - - - - - - - - - - - - - - 7-3 Controls affecting acoustic output- - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-5 Probe surface temperature safety mechanisms - - - - - - - - - - - - - - - - - - 7-6 Acoustic Parameters as Measured in Water - - - - - - - - - - - - - - - - - - - - 7-7 Acoustic Output Reporting Tables for Track 3/EN/IEC 60601-2-37 - - - - 7-9

Appendices Statements on the safety of ultrasound - - - - - - - - - - - - - - - - - - - - - - - 7-33

Measurement accuracy Measurement accuracy - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-34

OB Tables Abdominal Circumference (AC) HADLOCK 84- - - - - - - - - - - - - - - - - - 7-39 Biparietal Diameter (BPD) HADLOCK 84 - - - - - - - - - - - - - - - - - - - - - 7-40 Crown Rump Length (CRL) HADLOCK- - - - - - - - - - - - - - - - - - - - - - - 7-41 Femur Length (FL) HADLOCK 84- - - - - - - - - - - - - - - - - - - - - - - - - - - 7-43 Head Circumference (HC) HADLOCK 84 - - - - - - - - - - - - - - - - - - - - - 7-44 EFW Hadlock 1 (AC, FL) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-45 EFW Hadlock 2 (BPD, AC, FL)- - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-45 EFW Hadlock 3 (HC, AC, FL)- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-46 EFW Hadlock 4 (BPD, HC, AC, FL) - - - - - - - - - - - - - - - - - - - - - - - - - 7-46

Vscan Air™ CL and SL Indications reference guide Disclaimer - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-47 Curved Array (Deep scanning) Transducer - - - - - - - - - - - - - - - - - - - - 7-47 Linear Array (Shallow scanning) Transducer - - - - - - - - - - - - - - - - - - - 7-49 Sector Array (deep scanning) transducer - - - - - - - - - - - - - - - - - - - - - 7-52

Index

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Chapter 1 Introduction Contents: ‘Overview’ on page 1-2 ‘Warnings’ on page 1-13 ‘Contact information’ on page 1-15

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1-1

Introduction

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:

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.

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: •

1-2

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.

Vscan Air – User Manual GP092019-1EN Rev 08

Overview Documentation (continued) •

NOTE:

The Privacy and Security Manual (TRANSLATED) describes privacy and security considerations, privacy and security capabilities, and how they are configured and used appropriately. For Privacy and Security Manual, reach out to your GE HealthCare sales representative or GE HealthCare support team. Users can download the Privacy and Security Manual by registering and logging in to GE HealthCare’s Product Security Portal. https://www.gehealthcare.com/productsecurity/products

•

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.

NOTE:

The 'Electronic Instructions For Use' leaflet provided with the Vscan Air probe holds instructions on how to access user documentation available in electronic format. The Vscan Air user manual is written for users who are familiar with basic ultrasound principles and techniques and does not include sonographic training or detailed clinical procedures. The Vscan Air user documentation is available in English and translations are available.

NOTE:

The screen graphics in this manual are only for illustration purposes and screen graphics text is replicated in English only. Actual screen output may differ with different software (SW) revisions.

Vscan Air – User Manual GP092019-1EN Rev 08

1-3

Introduction Documentation (continued) NOTE:

The labels displayed in this manual are only for illustration purposes. The label content may be different for different regions. Please refer to the system product labels for the actual content. This manual covers the following configurations of the Vscan

Air:

1. Vscan Air software application (app): • •

Vscan Air R2 for iOS Vscan Air R2 for Android

2. Vscan Air CL probe 3. Vscan Air SL probe The table below lists the Vscan Air probe configurations covered by this manual: Table 1-1: Item

NOTE:

1-4

Vscan Air probe configurations

Vscan Air probe Part number

REF

1

GP000150

Vscan Air CL A1

2

GP000151

Vscan Air CL A2

3

GP000153

Vscan Air CL C1

4

GP000156

Vscan Air CL I1

5

GP000158

Vscan Air CL G1

6

GP000180

Vscan Air SL

The Vscan Air probes comes with different AC adapter configuration and different labeling depending on which country or region it is shipped.

Vscan Air – User Manual GP092019-1EN Rev 08