Vscan Extend User Manual Rev D

Regulatory requirement This product complies with regulatory requirements of the following European Directive 93/42/EEC concerning medical devices.

This manual is a reference for the Vscan Extend. It applies to all versions of the 1.0 software for the Vscan Extend ultrasound system.

Manufacturer: GE VINGMED ULTRASOUND A/S Strandpromenaden 45 3191 Horten, Norway Tel.: (+47) 3302 1100 Fax: (+47) 3302 1350

Revision History Reason for Change

REV

DATE (YYYY/MM/DD)

REASON FOR CHANGE

Rev. A

2016/04/05

Initial draft

Rev. B

2016/05/19

Included External Battery charger label Included Power button under device labels Included revised rating label Included sections in Privacy and Security chapter

Rev. C

2016/06/01

Removed breast and testes from indication of use statement Included the revised rating label, battery label and external charger label Included the scope for all the standards in Table i-1

Rev. D

2016/08/18

Included IP33, Ophthalmic and Aorta presets, IEC 60601-11 and 12 standards, Tricefy App

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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Vscan Extend – User Manual 5721203-100 Rev. D

Regulatory Requirements

Conformance Standards The GE 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 system must be approved by the manufacturer: GE Medical Systems. 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

93/42/EEC

Medical Devices Directive (MDD) 2007/47/EC (MDD amendment) Directive 2011/65/EU RoHS 2002/96/EC WEEE 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.

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* 60601-1-4

Medical Electrical Equipment - part 1-4. Collateral standard: Programmable electrical medical systems

IEC* 60601-1-6

Medical Electrical Equipment - part 1-6. Collateral standard: Usability.

NEMA/AIUM UD-3

Standard for real-time display of thermal and mechanical acoustic output indices on diagnostic ultrasound equipment.

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Table i-1: Standard/Directive

Regulatory Requirements (Continued) Scope

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

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

* including national deviations

Certifications •

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GE Vingmed Ultrasound is ISO 13485 certified.

Vscan Extend – User Manual 5721203-100 Rev. D

Classifications The following classifications are in accordance with the IEC/ EN 60601-1. Type and degree of protection against electric shock: •

Vscan Extend has an internal battery which allows the operation during AC power absence.

•

The AC adapter is Class II.

•

Vscan Extend has type BF Applied Part.

Vscan Extend main unit is rated IP33: •

3: Protected against solid foreign objects of 2,5 mm Ø and greater.

•

3: Protected against spraying water.

Vscan Extend probe (immersible portion) is IPX7.

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 particular regard to allowable LEAKAGE CURRENT. Table i-2:

Leakage Current

Normal mode Patient leakage current

<100 microA

Single fault condition <500 microA

Original Documentation •

The original document was written in English.

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Country Specific Approval •

USA AND TERRITORIES The following optional feature IS NOT available in the USA and its territories:

DANGER

– Ophthalmalic •

JAPAN The following optional feature IS NOT available in JAPAN:

DANGER

– Ophthalmalic

•

CHINA

The following optional feature IS NOT available in CHINA:

DANGER

– Ophthalmalic

Importer Information Turkey

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Vscan Extend – User Manual 5721203-100 Rev. D

Table of Contents

Conformance Standards - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-3 Certifications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-4 Classifications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-5 Class II Equipment - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-5 Type BF Applied part - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-5 Original Documentation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-5 Country Specific Approval - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-6 Importer Information - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-6

Table of Contents Chapter 1 - Introduction Overview Attention - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-2 General description- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-2 Principles of operation- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-3 Safety - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-3 Intended use - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-3 Indications for use (for all countries except USA, China and Japan)- - - - 1-4 Indications for use (for USA, China and Japan) - - - - - - - - - - - - - - - - - - 1-5 Contraindication for use (for USA, China and Japan) - - - - - - - - - - - - - - 1-5 Intended users - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-6 Prescription Device - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-6 Operator profile - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-6

Warnings Important Safety Considerations - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-7

Contact Information Contacting GE Ultrasound - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-10 Global ultrasound support center phone numbers - - - - - - - - - - - - - - - 1-11 Manufacturer - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-14

Chapter 2 - Safety Introduction Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-2

Owner responsibility Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-3 Notice against user modification- - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-4

Important safety considerations Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-5 Patient Safety- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-5 Diagnostic information- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-6

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General precautionary advice for the use of diagnostic ultrasound in combination with ultrasound contrast agents - - - - - - - - - - - - - - - - - 2-6 Mechanical hazards - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-6 Electrical hazard - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-7 Personnel and equipment safety - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-7 Explosion hazard - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-7 Electrical hazard - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-8 Electromagnetic Compatibility (EMC) - - - - - - - - - - - - - - - - - - - - - - - - 2-10 Electromagnetic emissions - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-14 Electromagnetic immunity - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-14 Separation distances- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-18 Essential Performance - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-18 Acoustic output- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-19 Environmental protection - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-23

Maximum probe temperature Device labels and symbols Vscan Extend Labels (Example)- - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-25 Explanation of the Pollution control label for China- - - - - - - - - - - - - - - 2-29

Chapter 3 - Preparing Vscan Extend for Use Package contents Vscan Extend package contents - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-2

Environmental requirements Environmental requirements for the device - - - - - - - - - - - - - - - - - - - - - 3-3

System description System overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-4 Accessories and Configurations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-7 External battery charger compartment (option) - - - - - - - - - - - - - - - - - 3-11 Display screens - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-12

Vscan Extend Battery Battery- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-15

Initial use First time use - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-22 Power on/off- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-22 Vscan Extend activation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-24

Chapter 4 - Vscan Extend Settings Settings Scan Settings - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-2 Server Settings- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-3 Diagnostics - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-12 System Settings - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-13 Administrator Access - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-15 Storage Access - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-17 Wi-Fi - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-21 Configuring Wi-Fi - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-23 MDM Installation Procedures (Optional) - - - - - - - - - - - - - - - - - - - - - - 4-24 Certificate Authority- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-28 GE Marketplace - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-31

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Vscan Extend – User Manual 5721203-100 Rev. D

Chapter 5 - Using Vscan Extend Scanning General scanning recommendations- - - - - - - - - - - - - - - - - - - - - - - - - - 5-2 Black and white imaging - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-17 Color imaging - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-20 Auto freeze - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-23 AutoCycle - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-23 Use of sterile sheath - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-23

Measurements Taking measurements- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-24

Review and recall of stored data Backups Recommended - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-26 Reviewing and recalling images or videos from an exam list - - - - - - - - 5-26 Deletion of data - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-28 Data Export - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-30 Backup - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-42 Restore - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-45

Using Vscan Extend Apps Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-47 Bladder Volume - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-47 Lung Protocol - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-54 Tricefy - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-62

Chapter 6 - Vscan Extend Maintenance System care and maintenance Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-2 Inspection - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-3

Cleaning and disinfection Cleaning the device - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-4 Method of cleaning: Manual - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-6 Disinfecting the device - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-7 Disinfecting the probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-9 Rinsing and Lubricating Agents - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-11

Upgrade software Scanner software - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-12

Troubleshooting Vscan Extend troubleshooting - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-14 System Warning Messages - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-16

Chapter 7 - Appendix Specifications Dimension and weight - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-2 Phased array transducer for deep scanning - - - - - - - - - - - - - - - - - - - - 7-2 Linear transducer for shallow scanning - - - - - - - - - - - - - - - - - - - - - - - - 7-2

Acoustic Output Reporting Tables Definitions, symbols and abbreviations - - - - - - - - - - - - - - - - - - - - - - - - 7-3 Acoustic Output Reporting Tables for Track 3/EN/IEC 60601-2-37 - - - - 7-6

Measurement accuracy Basic Measurements- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-12

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Chapter 8 - Privacy and Security Introduction Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-2 How to contact GE - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-2 Privacy and Security Environment - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-3

Network Connectivity Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-6 System interconnections - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-6 Network Requirements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-8 Network Protocols- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-8

Information Protection Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-9 Network Security - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-9

System Protection Vscan Extend – system protection - - - - - - - - - - - - - - - - - - - - - - - - - - 8-16

Personal Information Collected by the Product Information collection and use - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-17 Manual information collection - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-18 Information disclosure - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-19 Retention and destruction of personal information - - - - - - - - - - - - - - - 8-19 Potential Hazardous Situations Resulting From Failures of the IT Network - 8-21

Index

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Vscan Extend – User Manual 5721203-100 Rev. D

Chapter 1 Introduction

Contents: ‘Overview’ on page 1-2 ‘Warnings’ on page 1-7 ‘Contact Information’ on page 1-10

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Introduction

Overview

Attention This manual covers the following two configurations of the Vscan Extend. Refer to the relevant section based on the configuration purchased. •

Vscan ExtendTM configured with a sector probe allowing deep scanning (holding the phased array transducer G3S)

•

Vscan ExtendTM configured with a Dual Probe allowing deep and shallow scanning (holding the phased array transducer G3S and the linear array transducer G8L)

Vscan Extend is a trademark of General Electric Company.

General description Vscan Extend is a pocket-sized, battery powered general purpose diagnostic ultrasound system. The system consists of a handheld unit with a 5 inch touch screen display and a permanently attached probe. The battery can be charged either in the system or alone. The system is capable of transferring images wirelessly to a DICOM server or via Windows Share. Data can also be exported to a standard PC using a wired USB export. Capabilities also include access to GE Marketplace, which allows the user to download Bladder Volume, Lung Protocol, Barcode Reader and Interface to Case Exchange Software Apps.

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Overview Principles of operation Medical ultrasound images are created by computer and digital memory from the transmission and reception of mechanical high-frequency waves applied through a probe. The mechanical ultrasound waves spread through the body, producing an echo where density changes occur. The echoes return to the probe where they are converted back into electrical signals. These echo signals are amplified and processed by several analog and digital circuits having filters with many frequency and time response options, transforming the high-frequency electrical signals into a series of digital image signals which are stored in memory. Once in memory, the image can be displayed in real-time on the image monitor. A probe is an accurate, solid-state device, providing multiple image formats. The digital design and use of solid-state components provides highly stable and consistent imaging performance with minimal required maintenance.

Safety Read and understand all instructions in the User's Manual before attempting to use the ultrasound unit. Keep the manual with the equipment at all time. Periodically review the procedures for operation and safety precautions.

Intended use Vscan Extend is a general purpose diagnostic ultrasound imaging system for use by qualified and trained healthcare professionals enabling visualization and measurement of anatomical structures and fluid.

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Introduction Indications for use (for all countries except USA, China and Japan) Vscan Extend is a general purpose diagnostic ultrasound imaging system for use by qualified and trained healthcare professionals enabling visualization and measurement of anatomical structures and fluid. It's pocket-sized portability and simplified user interface enables integration into examination and training sessions indoors and in other environments described in the user manual. The information can be used for basic/focused assessments and adjunctively with other medical data for clinical diagnosis purposes during routine, periodic monitoring, and triage. With the phased array transducer on the sector probe, the specific clinical applications and exam types include: Cardiac; Abdominal; Renal; OB/GYN; Urology; Fetal, Evaluation of Presence of Fluid; Imaging Guidance for Needle/Catheter Placement (e.g. paracentesis, pericardiocentesis, thoracentesis, amniocentesis); Peripheral Vascular Imaging (e.g. arteries and veins); Thoracic/Lung (e.g. pleural motion/sliding, line artifacts); Adult Cephalic; and Pediatrics. With the addition of the linear array transducer on the single dual headed probe solution, the specific clinical applications and exam types are expanded to include: Peripheral vascular imaging (e.g. lower extremity, carotid); Procedure Guidance for Arterial or Venous Vessels (e.g. central lines, upper extremity); Small Organs (e.g. thyroid); Musculoskeletal (Long Bone; Hip, shoulder, elbow and Knee Joints); Evaluation of Presence of Fluid; Thoracic/Lung (e.g. pleural motion/sliding, line artifacts); Ophthalmic*; and Pediatrics.

WARNING

*Ophthalmic use is provided as an option. Ophthalmic scanning MUST only be used with the linear functionality of the Dual Probe. If the Vscan Extend purchased does NOT have the Ophthalmic preset option, DO NOT use for ophthalmic use or any use causing the acoustic beam to pass through the eye.

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Vscan Extend – User Manual 5721203-100 Rev. D

Overview Indications for use (for USA, China and Japan) Vscan Extend is a general purpose diagnostic ultrasound imaging system for use by qualified and trained healthcare professionals enabling visualization and measurement of anatomical structures and fluid. It's pocket-sized portability and simplified user interface enables integration into examination and training sessions indoors and in other environments described in the user manual. The information can be used for basic/focused assessments and adjunctively with other medical data for clinical diagnosis purposes during routine, periodic monitoring, and triage. With the phased array transducer on the sector probe, the specific clinical applications and exam types include: Cardiac; Abdominal; Renal; OB/GYN; Urology; Fetal, Evaluation of Presence of Fluid; Imaging Guidance for Needle/Catheter Placement (e.g. paracentesis, pericardiocentesis, thoracentesis, amniocentesis); Peripheral Vascular Imaging (e.g. arteries and veins); Thoracic/Lung (e.g. pleural motion/sliding, line artifacts); Adult Cephalic; and Pediatrics. With the addition of the linear array transducer on the single dual headed probe solution, the specific clinical applications and exam types are expanded to include: Peripheral vascular imaging (e.g. lower extremity, carotid); Procedure Guidance for Arterial or Venous Vessels (e.g. central lines, upper extremity); Small Organs (e.g. thyroid); Musculoskeletal (Long Bone; Hip, shoulder, elbow and Knee Joints); Evaluation of Presence of Fluid; Thoracic/Lung (e.g. pleural motion/sliding, line artifacts); and Pediatrics.

Contraindication for use (for USA, China and Japan) The Vscan Extend ultrasound device is not intended for ophthalmic use or any use causing the acoustic beam to pass through the eye.

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Introduction Intended users Vscan Extend is intended to be used by qualified and trained healthcare professionals that are legally authorized by law in the country, state or other local municipality in which he practices to use the device. The list of the potential users includes but is not limited to (based on title/geographical location): primary care physicians, point-of-care users, sonographers, medical healthcare technicians, nurses, midwives, paramedics, nurse practitioner, physician assistants, medical students. The users may or may not be working under supervision or authority of a physician.

Prescription Device For USA only: CAUTION: Federal law restricts this device to sale by or on the order of a physician.

Operator profile Qualified and trained healthcare professionals with at least a basic level of general ultrasound training that includes limited image acquisition techniques and interpretation (i.e. position the probe correctly on the patient and determine at least normal vs. abnormal anatomy views during scanning).

CAUTION

The operator must read and understand the user manual.

Contact GE sales representative for product training assistance and visit the Vscan web portal for reference materials.

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Vscan Extend – User Manual 5721203-100 Rev. D

Warnings

Warnings

Important Safety Considerations To prevent damage of the equipment or injury to yourself or others, read the following safety warnings before using Vscan Extend. WARNING

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Vscan Extend is a precision instrument. Handle Vscan Extend and its accessories with care. Do not subject Vscan Extend to mechanical shock or impact.

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Do not attempt to disassemble or alter any part of the unit including the probe, the battery, the AC/DC adapter and accessories. Disassembly or modification may result in electrical shock.

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Stop using the unit if it emits smoke or noxious fumes. Failure to do so may result in electrical shock or fire.

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Stop using the unit if the casing is damaged, including the probe. Failure to do so may result in electrical shock.

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Do not use the device if the gorilla glass is broken.

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Do not use the AC/DC adapter if showing visible damages.

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Use only the designated power accessories (battery and charger). Failure to do so may result in electrical shock or fire.

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Do not place the battery near a heat source or expose it to direct flame. Such exposure may lead to corrosive liquid leakage, electrical shock or fire.

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To reduce risk for electrical shock, do not plug or unplug the AC/DC adapter from mains socket with wet hands.

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Avoid dropping or subjecting the unit, including the probe, the battery and accessories to severe impacts. This could result in electrical shock, corrosive liquid leakage and injury.

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Keep good hand contact with Vscan Extend during scanning to avoid heating up of the unit and termination of scan due to built-in temperature limits.

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At times, user may be required to enter PIN to save patient data. It is extremely important to remember this PIN in order to avoid loss of patient data in case of entering wrong PIN multiple times or if the user forgets the PIN.

Vscan Extend – User Manual 5721203-100 Rev. D

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Introduction Important Safety Considerations (continued)

WARNING

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Do not short-circuit the battery terminal with metallic objects. This may result in overheating and burns.

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Do not store or carry a battery loosely with metallic devices.

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Disconnect the battery charger when not in use to avoid fire hazard.

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Keep the charger dry. Failure to observe this precaution may result in fire and electric shock

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Keep this unit out of reach of children. Strangulation resulting from baby or child entanglement in probe cable may occur.

Before charging or using a battery it is important that you read and understand the battery safety and environment information.

WARNING

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Do not damage the rechargeable battery. A damaged battery can cause an explosion or fire, and can result in personal injury and/or property damage. To prevent injury or damaged do not use or charge the battery if it appears to be damaged. Signs of damage include, but are not limited to, discoloration, warping, and leaking battery fluid. Do not expose the battery to fire, high temperature, or direct sunlight. Do not immerse or expose the battery to water. Do not use or store the battery inside a vehicle during hot weather. Do not drop or puncture the battery. Do not open the battery or short-circuit its contacts.

WARNING

Avoid contact with the rechargeable battery if it appears to be leaking. Battery fluid is corrosive, and contact with it can result in personal injury and/or property damage. To prevent injury or damage:

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If the battery leaks, avoid contact with the battery fluid. If any liquid from the battery should come in contact with the eye, immediately wash the eye with plenty of water and seek medical advice as soon as possible. Do not rub your eyes!

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If battery fluid gets onto your skin or clothing, immediately use clean water to wash off the battery fluid.

Vscan Extend – User Manual 5721203-100 Rev. D