GE Vscan Extend User manual

Technical Publications
Vscan Extend™
Version 1.0
User Manual
5721203-100 — English
Rev. D
Operating Documentation
Copyright © 2016 By General Electric Co.

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.: [phone] Fax: [phone]

Vscan Extend – User Manual i-1
5721203-100 Rev. D
Revision History
Reason for Change
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.
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

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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: Regulatory Requirements
Standard/Directive 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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Certifications
• GE Vingmed Ultrasound is ISO 13485 certified.
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
Table i-1: Regulatory Requirements (Continued)
Standard/Directive Scope

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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:
• Vscan Extend has an internal battery which allows the
operation during AC power absence.
• The AC adapter is Class II.
• Vscan Extend has type BFApplied 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.
Original Documentation
• The original document was written in English.
Table i-2: Leakage Current
Normal mode Single fault condition
Patient leakage current <100 microA <500 microA

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Country Specific Approval
• USA AND TERRITORIES
• JAPAN
• CHINA
Importer Information
Turkey
DANGER
The following optional feature IS NOT available in the USA
and its territories:
– Ophthalmalic
DANGER
The following optional feature IS NOT available in JAPAN:
– Ophthalmalic
DANGER
The following optional feature IS NOT available in CHINA:
– Ophthalmalic

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

Introduction
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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.

Overview
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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.

Introduction
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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.

Overview
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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.

Introduction
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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).
Contact GE sales representative for product training assistance
and visit the Vscan web portal for reference materials.
CAUTION The operator must read and understand the user manual.

Warnings
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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 • Vscan Extend is a precision instrument. Handle Vscan
Extend and its accessories with care. Do not subject Vscan
Extend to mechanical shock or impact.
• 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.
• Stop using the unit if it emits smoke or noxious fumes.
Failure to do so may result in electrical shock or fire.
• Stop using the unit if the casing is damaged, including the
probe. Failure to do so may result in electrical shock.
• Do not use the device if the gorilla glass is broken.
• Do not use the AC/DC adapter if showing visible damages.
• Use only the designated power accessories (battery and
charger). Failure to do so may result in electrical shock or
fire.
• 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.
• To reduce risk for electrical shock, do not plug or unplug
the AC/DC adapter from mains socket with wet hands.
• 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.
• 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.
• 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.

Introduction
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Important Safety Considerations (continued)
Before charging or using a battery it is important that you read
and understand the battery safety and environment information.
WARNING • Do not short-circuit the battery terminal with metallic
objects. This may result in overheating and burns.
• Do not store or carry a battery loosely with metallic
devices.
• Disconnect the battery charger when not in use to avoid
fire hazard.
• Keep the charger dry. Failure to observe this precaution
may result in fire and electric shock
• Keep this unit out of reach of children. Strangulation
resulting from baby or child entanglement in probe cable
may occur.
WARNING • 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 damageddo not useor 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:
• 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!
• If battery fluid gets onto your skin or clothing, immediately
use clean water to wash off the battery fluid.