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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.: (+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.
Vscan Extend – User Manual
5721203-100 Rev. D
i-1
This page intentionally left blank.
i-2
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.
Vscan Extend – User Manual
5721203-100 Rev. D
i-3
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
•
i-4
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.
Vscan Extend – User Manual
5721203-100 Rev. D
i-5
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
i-6
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 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - General description- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Principles of operation- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Safety - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Intended use - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Indications for use (for all countries except USA, China and Japan)- - - Indications for use (for USA, China and Japan) - - - - - - - - - - - - - - - - - Contraindication for use (for USA, China and Japan) - - - - - - - - - - - - - Intended users - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Prescription Device - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Operator profile - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
1-2
1-2
1-3
1-3
1-3
1-4
1-5
1-5
1-6
1-6
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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i-7
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
i-8
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 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Reviewing and recalling images or videos from an exam list - - - - - - - Deletion of data - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Data Export - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Backup - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Restore - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
5-26
5-26
5-28
5-30
5-42
5-45
Using Vscan Extend Apps
Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Bladder Volume - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Lung Protocol - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Tricefy - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
5-47
5-47
5-54
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
Vscan Extend – User Manual
5721203-100 Rev. D
i-9
Chapter 8 — Privacy and Security
Introduction
Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-2
How to contact GE - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-2
Privacy and Security Environment - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-3
Network Connectivity
Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - System interconnections - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Network Requirements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Network Protocols- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
8-6
8-6
8-8
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
i-10
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
Vscan Extend – User Manual
5721203-100 Rev. D
1-1
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.
1-2
Vscan Extend – User Manual
5721203-100 Rev. D
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.
Vscan Extend – User Manual
5721203-100 Rev. D
1-3
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.
1-4
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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.
Vscan Extend – User Manual
5721203-100 Rev. D
1-5
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.
1-6
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
•
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.
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1-7
Introduction
Important Safety Considerations (continued)
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.
Before charging or using a battery it is important that you read
and understand the battery safety and environment information.
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 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:
1-8
•
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.
Vscan Extend – User Manual
5721203-100 Rev. D
Warnings
Important Safety Considerations (continued)
WARNING
Charge and use the rechargeable battery only in strict
accordance with the instructions. Charging or using the battery
in unauthorized equipment can cause an explosion or fire, and
can result in personal injury and/or equipment damage.
To prevent injury or damage:
CAUTION
CAUTION
•
Do not charge or use the battery if it appears to be
damaged or leaking.
•
Charge the battery only in a Vscan Extend device or in the
Vscan Extend battery charger. Be sure to follow all
instructions that are provided with the battery charger.
•
Discontinue charging a battery that gives off extreme heat
or a burning odor.
•
Use the battery only in the Vscan Extend.
•
Use the battery only for its intended use and according to
the instructions in the product documentation.
•
Ensure to backup data regularly and to erase the data
before sending the Vscan Extend for service.
•
To access or add patient information, a device pin is
required. Ensure not to lose the pin.
Vscan Extend cannot be sterilized. Apply a sterile sheath if the
device is going to be used in an application where a higher
degree of cleanliness is required. The sheath should cover the
probe and any part of the probe cable that might come in
contact with the area requiring higher cleanliness.
Vscan Extend – User Manual
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1-9
Introduction
Contact Information
Contacting GE Ultrasound
For additional information or assistance, please contact your
local distributor or the appropriate support resource listed on the
following pages:
Internet
https://vscan.gehealthcare.com
http://www.gehealthcare.com
USA
TEL: (1) 800-437-1171
Ultrasound Service Engineering
9900 Innovation Drive
Wauwatosa, WI 53226
Clinical Questions
Please contact your local Applications or Sales Representative.
Service Questions
For service contact your local Service Representative.
1-10
Vscan Extend – User Manual
5721203-100 Rev. D
Contact Information
Accessories Catalog Requests
To request the latest GE Accessories catalog or equipment
brochures in the United States, call the Response Center
TEL: (1) 800-643-6439
In other locations, contact your local Applications, Sales or
Service Representative.
Placing an order
To place an order, order supplies or ask an accessory-related
question in the United States, call the GE Access Center
TEL: (1) 800-472-3666
In other locations, contact your local Applications, Sales or
Service Representative.
Global ultrasound support center phone numbers
For countries not listed in the tables below, please contact the
local distributor.
When contacting Support you will have to provide your system
ID. If the system ID is unknown, please give the Temporary
System ID “Vscan Extend” to be properly routed for support.
Americas
Table 1-1:
Americas
Region
Telephone
United States1
800-437-1171
Canada
800-668-0732
Mexico
0800 9043400
Puerto Rico
0800 4371171
Brazil
0800 122345
Argentina
0800 3331984
Chile
0800 367000
For USA only: when contacting GE CARES you will have to provide your system ID. If system ID is
unknown, please give the Temporary System ID “Vscan Extend” to be properly routed for support.
Vscan Extend – User Manual
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1-11
Introduction
Europe, Middle East and Africa
Table 1-2:
Europe, Middle East and Africa
Region
Telephone
Algeria
+21321484612
Andorra
902 400 246
Austria
0800244260
Belgium Dutch
+32 262 638 38
Belgium French
+32 262 638 39
Bulgarian
+35929712040
Denmark
80404944
Egypt
+202 19434 [hot line]
Finland
0981710182
France
0800139140
G. D. Luxembourg
080022973
Germany
08004373784
Greece
302109690660
Holy See
800 827168
Hungary
+36-23-410-510
Ireland
1800992557
Israel
Contact local distributor
Italy Central
800 827168
Italy North-East
800 827166
Italy North-West
800 827164
Italy South
800 827170
Liechtenstein
0041 44 809 9293
Monaco
0800139140
Netherlands
8000994442
Northern Ireland
08000720248
Norway
80062043
Portugal
800 834 004
Russia
+7 495 739 69 75
San Marino
800 827168
1-12
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5721203-100 Rev. D
Contact Information
Table 1-2:
Europe, Middle East and Africa (Continued)
Region
Telephone
Saudi Arabia
800 1243002
South Africa
800 111 671
Spain
902 400 246
Sweden
0201201436
Switzerland
0800556958
Turkey
Contact local distributor
UAE
800 3646
UK
0845 8503392
Ukraine
+38 044 391 37 56 (57)
Vscan Extend – User Manual
5721203-100 Rev. D
1-13
Introduction
Asia and Pacific
Table 1-3:
Asia and Pacific
Region
Telephone
China
8008108188
Hong Kong
(852) 21006288
Taiwan
0800-021-770
India
(91) 1800-425-8025
Singapore
(65) 62773444
Australia
1-800-659-465
New Zealand
0800 65 94 65
Japan
0120-055-919
Korea
(82) 2-1544-6119
Bangladesh
(880) 29135488
Sri Lanka
(94) 114891178
Bhutan
Contact GE India
Maldives
Contact GE India
Nepal
Contact local distributor
Malaysia
1800 88 3911
Thailand
(66) 26248400
Vietnam
Contact local distributor
Philippines
Contact local distributor
Indonesia
Contact local distributor
Laos
Contact local distributor
Brunei Darussalam
Contact local distributor
Cambodia
Contact local distributor
Manufacturer
GE VINGMED ULTRASOUND A/S
Strandpromenaden 45
3191 Horten, Norway
TEL: (+47) 3302 1100; FAX: (+47) 3302 1350
1-14
Vscan Extend – User Manual
5721203-100 Rev. D
Chapter 2
Safety
Contents:
‘Introduction’ on page 2-2
‘Owner responsibility’ on page 2-3
‘Important safety considerations’ on page 2-5
‘Maximum probe temperature’ on page 2-24
‘Device labels and symbols’ on page 2-25
Vscan Extend – User Manual
5721203-100 Rev. D
2-1
Safety
Introduction
Overview
This chapter describes the important safety measures which
should be taken before operating the Vscan Extend. Procedures
for simple care and maintenance of the Vscan Extend are also
described.
Various levels of safety precautions may be found on the
equipment, and different levels of severity are identified by one
of the following icons that precede precautionary statements in
the text.
The following icons are used to indicate precautions:
DANGER
WARNING
CAUTION
2-2
Indicates that a specific hazard is known to exist which through
inappropriate conditions or actions will cause:
•
Severe or fatal personal injury
•
Substantial property damage.
Indicates that a specific hazard is known to exist which through
inappropriate conditions or actions may cause:
•
Severe personal injury
•
Substantial property damage.
Indicates that a potential hazard may exist which through
inappropriate conditions or actions will or can cause:
•
Minor injury
•
Property damage.
Vscan Extend – User Manual
5721203-100 Rev. D
Owner responsibility
Owner responsibility
Overview
It is the responsibility of the owner to ensure that anyone
operating Vscan Extend reads and understands this section of
the manual. However, there is no representation that the act of
reading this manual renders the reader qualified to operate,
inspect, test, align, calibrate, troubleshoot, repair or modify the
system. The owner should make certain that only properly
trained, fully-qualified service personnel undertake maintenance
of the equipment. There are no user serviceable parts in the
system or accessories. If servicing is required, contact GE. See
‘Contact Information’ on page 1-10 for more information.
The owner of Vscan Extend should ensure that only properly
trained, fully qualified personnel are authorized to operate the
system. Before authorizing anyone to operate the system, it
should be verified that the person has read, and fully
understands, the operating instructions contained in this
manual. It is advisable to maintain a list of authorized operators.
Should the system fail to operate correctly, or if Vscan Extend
does not respond to the commands described in this manual,
the operator should contact the nearest field GE Ultrasound
Service Office.
For information about specific requirements and regulations
applicable to the use of electronic medical equipment, consult
the local, state and federal agencies.
Vscan Extend – User Manual
5721203-100 Rev. D
2-3
Safety
Overview (continued)
The owner of Vscan Extend MUST be aware of the data
protection policies while configuring the DICOM and Windows
Share servers. GE is not responsible for data sharing. Before
configuring the servers, the owner of the Vscan Extend MUST
abide by the applicable privacy acts specific to their region or
country.
CAUTION
For USA only:
Federal law restricts this device to sale by or on the order of a
physician.
CAUTION
Vscan Extend should be used in compliance with law. Some
jurisdictions restrict certain uses, such as gender
determination.
Notice against user modification
Never modify this product, including system components,
cables, and so on. User modification may cause safety hazards
and degradation in system performance. All modification must
be done by a GE qualified person.
Software upgrade following GE recommendations can be done
by the user.
2-4
Vscan Extend – User Manual
5721203-100 Rev. D
Important safety considerations
Important safety considerations
Overview
This section includes considerations for the following:
•
Patient safety
•
Personnel and equipment safety
The information contained in this section is intended to
familiarize the user with the hazards associated with the use of
Vscan Extend, and to alert them to the extent to which injury and
damage may occur if the precautions are not observed.
Users are obligated to familiarize themselves with these safety
considerations and to avoid conditions that could result in injury
or damage.
Patient Safety
Patient identification
WARNING
The concerns listed in this section can seriously affect the
safety of the patient undergoing a diagnostic ultrasound
examination.
Always include proper identification with all patient data.
Identification errors could result in an incorrect diagnosis.
If the Vscan Extend needs to be sent for repair, ensure that the
patient information is backed up and confirm backup was
successful. The patient information MUST be erased from
internal memory (See ‘Backup’ on page 5-42 for more
information.) before shipping.
CAUTION
To access or add patient information, a device pin is required.
Retain the 4-digit pin in a safe location to prevent loss of the
pin. Avoid sharing the PIN. See ‘Administrator Access’ on
page 4-15 for more information.
Vscan Extend – User Manual
5721203-100 Rev. D
2-5
Safety
Diagnostic information
The images and calculations provided by the system, including
bladder volume and lung protocol, are intended for use by
competent users, as a diagnostic tool. They are not to be
explicitly regarded as the sole, irrefutable basis for clinical
diagnosis. Users are encouraged to study the literature and
reach their own professional conclusions regarding the clinical
use of the system.
The user should be aware of the product specifications and of
the system accuracy and stability limitations. These limitations
must be considered before making any decision based on
quantitative values. If in doubt, the nearest GE Ultrasound
Service Office should be consulted.
Equipment malfunction or incorrect settings can result in
measurement errors or failure to detect details in the image. The
user must become thoroughly familiar with the operation of the
Vscan Extend in order to optimize its performance and to
recognize possible malfunctions.
CAUTION
Avoid reflections from windows/lamps/direct sunlight on the
display. Avoid analyzing data from small viewing angles.
General precautionary advice for the use of diagnostic ultrasound in
combination with ultrasound contrast agents
CAUTION
The Vscan Extend is not intended to be used with a contrast
agent. Cardiac rhythm disturbances during cardiac studies
using gas ultrasound contrast agents have been observed in
the diagnostic range of Mechanical Index (MI) values. See the
specific package insert for the contrast agent being used for
further details.
Mechanical hazards
A damaged probe may result in injury or increased risk of
contamination. Inspect the probe frequently for sharp, pointed or
rough surface damage that could cause injury or tear protective
barriers (gloves and sheaths).
2-6
Vscan Extend – User Manual
5721203-100 Rev. D
Important safety considerations
Electrical hazard
A damaged probe may increase the risk of electric shock if
conductive solutions come in contact with internal electronics.
Inspect the probe often for cracks or openings in the housing
and holes in and around the acoustic lens, or other damage that
could allow moisture to enter. Become familiar with the probe's
care precautions outlined in ‘Inspecting the Vscan Extend’ on
page 6-3.
Personnel and equipment safety
DANGER
The hazards listed below can seriously affect the safety of
personnel and equipment during a diagnostic ultrasound
examination.
Explosion hazard
Never operate the equipment in the presence of flammable or
explosive liquids, vapors or gases. Malfunctions in the Vscan
Extend, or sparks, can electrically ignite these substances.
Operators should be aware of the following points to prevent
such explosion hazards.
•
If flammable substances are detected in the environment,
do not plug in or turn on the system.
•
If flammable substances are detected after the system has
been turned on, do not attempt to turn off the Vscan Extend,
or to unplug it.
•
If flammable substances are detected, evacuate and
ventilate the area before turning off Vscan Extend.
Vscan Extend – User Manual
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2-7
Safety
Electrical hazard
WARNING
NOTE:
The internal circuits of the AC/DC adapter use high voltages,
capable of causing serious injury or death by electrical shock.
Any rest energy within our scanners or their components will be
below 60 V DC or 2 mJ.
To avoid injury
•
Do not remove the Vscan Extend’s protective covers. No
user-serviceable parts are inside. If servicing is required,
contact GE service.
•
Conductive fluids seeping into the active circuit components
may cause short circuiting, which could result in an electrical
fire.
Pacemaker hazard
The possibility of the system interfering with pacemakers is
minimal. However, as this system generates high frequency
electrical signals, the operator should be aware of the potential
hazard this could cause.
Electrical Safety
Device classifications
Vscan Extend is an internally powered device, type BF.
The AC/DC adapter is Class II.
2-8
Vscan Extend – User Manual
5721203-100 Rev. D
Important safety considerations
External Connection
CAUTION
Connection to a PC can be done when the PC is in compliance
with the EN/IEC 60950 (Data processing equipment).
The computer connected to Vscan Extend must be kept
outside the patient environment (refer to local regulation and
EN/ES/IEC 60601-1).
Figure 2-1.
Patient environment
1. Patient environment
Allergic reactions to latex-containing medical devices
Due to reports of severe allergic reactions to medical devices
containing latex (natural rubber), the FDA advises healthcare
professionals to identify latex-sensitive patients, and be
prepared to treat allergic reactions promptly. Latex is a
component of many medical devices, including surgical and
examination gloves, catheters, incubation tubes, anesthesia
masks and dental dams. Patient reaction to latex has ranged
from contact urticaria, to systemic anaphylaxis.
For more details regarding allergic reaction to latex, refer to FDA
Medical Alert MDA91-1, March 29.
Vscan Extend – User Manual
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2-9
Safety
Electromagnetic Compatibility (EMC)
NOTE:
This unit carries the CE mark. It complies with regulatory
requirements of the European Directive 93/42/EEC concerning
medical devices. It also complies with emission limits for a
Group 1, Class B Medical Device as stated in EN/
IEC 60601-1-2.
Electrical medical equipment needs special precautions
regarding EMC and needs to be installed and put into service
according to the EMC information provided in this manual.
AII types of electronic equipment may characteristically cause
electromagnetic interference with other equipment, transmitted
either through air or connecting cables. The term
Electromagnetic Compatibility (EMC), indicates the capability of
the equipment to curb electromagnetic influence from other
equipment, while at the same time not affecting other equipment
with similar electromagnetic radiation.
Radiated or conducted electromagnetic signals can cause
distortion, degradation, or artifacts in the ultrasound image
which may impair the ultrasound unit’s essential performance
(see ‘Electrical Safety’ on page 2-8).
There is no guarantee that interference will not occur in a
particular installation. If this equipment is found to cause or
respond to interference, attempt to correct the problem by one
or more of the following measures:
•
Re-orient or re-locate the affected device.
•
Increase the separation between the unit and the affected
device.
•
Power the equipment from a source other than that of the
affected device.
•
Consult the service representative for further suggestions.
The manufacturer is not responsible for any interference or
responses caused by the use of interconnecting cables other
than those recommended, or by unauthorized changes or
modifications to this unit. Unauthorized changes or
modifications could void the user's authority to operate the
equipment.
To comply with the regulations on electromagnetic interference,
all interconnecting cables to peripheral devices must be
shielded and properly grounded. Use of cables not properly
shielded and grounded may result in the equipment causing or
responding to radio frequency interference, in violation of the
European Union Medical Device Directive and FCC regulations.
2-10
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5721203-100 Rev. D
Important safety considerations
Electromagnetic Compatibility (EMC) (continued)
Devices which intrinsically transmit radio waves such as cellular
phones, radio transceivers, mobile radio transmitters,
radio-controlled toys, and so on, should preferably not be
operated near the unit. See ‘Electromagnetic Compatibility
(EMC)’ on page 2-10 about the recommended minimum
separation distances between portable and mobile RF
communications equipment and the ultrasound unit.
Any electrical device can unintentionally emit electromagnetic
waves. However, minimum device separation distances cannot
be calculated for such unspecified electromagnetic radiation.
When the ultrasound unit is used adjacent to or in close
proximity to other equipment the user should be attentive to
unexpected device behavior which may be caused by such
electromagnetic radiation.
The ultrasound unit is intended for use in the electromagnetic
environment specified in the tables below.
The user of ultrasound unit should assure that the device is
used in such an environment.
FCC compliance statements
1. This device may not cause harmful interference, and
2. This device must accept any interference received,
including Interference that may cause undesired operation.
FCC Caution!!!
•
Any changes or modifications not expressly approved by the
party Responsible for compliance could void the user's
authority to operate this Equipment
•
This equipment should be installed and operated with
minimum distance 20 cm between the radiator & your body.
Part 15B compliance statements for digital devices:
NOTE:
This equipment has been tested and found to comply with the
limits for a Class B digital device, pursuant to part 15 of the FCC
Rules. These limits are designed to provide reasonable
protection against harmful interference in a residential
installation.
Vscan Extend – User Manual
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2-11
Safety
FCC compliance statements (continued)
This equipment generates, uses and can radiate radio
frequency energy and, if not installed and used in accordance
with the instructions, may cause harmful interference to radio
communications. However, there is no guarantee that
interference will not occur in a particular installation. If this
equipment does cause harmful interference to radio or television
Reception, which can be determined by turning the equipment
off and on, the user is encouraged to try to correct the
interference by one or more of the following measures:
•
Increase the separation between the equipment and
receiver.
•
Connect the equipment into an outlet on a circuit different
from that to which the receiver is connected
•
Consult the dealer or an experienced radio/TV technician for
help.
This Class B digital apparatus complies with Canadian
ICES-003.
This device complies with Industry Canada license-exempt RSS
standard(s). Operation is subject to the following two conditions:
1. This device may not cause interference, and
2. This device must accept any interference, including
interference that may cause undesired operation of the
device.
FCC compliance statements for Canada (French translation)
Le présent appareil est conforme aux CNR d'Industrie Canada
applicables aux appareils radio exempts de licence.
L'exploitation est autorisée aux.
deux conditions suivantes:
1. l'appareil ne doit pas produire de brouillage, et
2. l'utilisateur de l'appareil doit accepter tout brouillage
adioélectrique subi, même si le brouillage est susceptible
d'en compromettre le fonctionnement.
2-12
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Important safety considerations
FCC compliance statements for Canada (French translation) (continued)
This equipment complies with radio frequency exposure limits
set forth by Industry Canada for an uncontrolled Environment.
This equipment should be installed and operated with minimum
distance 20 cm between the device and the user or
bystanders.Cet équipement est conforme aux limites
d'exposition aux radiofréquences
définies par Industrie Canada pourun environnement non
contrôlé. Cet équipement doit être installé et utilisé avec un
minimum de 20 cm de distance entre le dispositif et l'utilisateur
ou des tiers.
un appareil numérique, en vertu de l’article 15 de la
réglementation de la FCC. Ces limites ont été instaurées pour
fournir une protection raisonnable contre toute interférence
nuisible dans une installation résidentielle. Cet équipement
génère, utilise et peut émettre de l’énergie radiofréquence. S’il
n’est pas installé et utilisé conformément aux instructions, il peut
provoquer des interférences sur les communications radio.
Cependant, il n’est pas garanti que des interférences ne se
produiront pas dans certaines installations. Si cet équipement
cause des interférences à la réception radio ou télévisée (ce qui
peut être vérifi é en éteignant l’appareil puis en le remettant
sous tension), l’utilisateur peut tenter de les résoudre en suivant
une ou plusieurs des mesures ci-après:
•
Réorienter ou déplacer l’antenne réceptrice. Augmenter
l’espace entre
•
l’appareil et le récepteur. Brancher l’appareil à une prise de
courant différente de celle sur laquelle le récepteur est
branché.
Pour obtenir de l’aide, contacter le vendeur ou un technician
radio/télévision expérimenté.
REMARQUE : Toute modifi cation non autorisée expressément
par le fabricant responsable de la conformité peut annuler le
droit de l’utilisateur à faire fonctionner le produit.
Vscan Extend – User Manual
5721203-100 Rev. D
2-13
Safety
Electromagnetic emissions
Table 2-1:
Electromagnetic emissions
Guidance and manufacturer’s declaration – electromagnetic emissions.
Emissions test
Compliance
Electromagnetic environment - guidance
RF emission
EN55011
Group 1
Class B
The Vscan Extend uses RF energy only for its internal
function. Therefore, its RF emissions are very low and
are not likely to cause any interference in nearby
electronic equipment.
RF emission
EN55011
Group 1
Class B
Harmonic emission
EN 61000-3-2
Complies
The Vscan Extend is suitable for use in all
establishments, including domestic establishments and
those directly connected to the public low-voltage power
supply network that supplies buildings used for domestic
purposes.
Voltage fluctuations/flicker
emissions
Complies
EN/IEC 61000-3-3
Electromagnetic immunity
Table 2-2:
Electromagnetic immunity (Part 1)
Guidance and manufacturer’s declaration – electromagnetic immunity.
The Vscan Extend is intended for use in the electromagnetic environment below. The
customer or the user of the Vscan Extend should assure that it is used in such an
environment.
Immunity test
EN 60601
test level
Compliance level
Electromagnetic
environment –
guidance
Electrostatic discharge
(ESD)
EN 61000-4-2
±6 kV contact
±8 kV air
±6 kV
±8 kV
Floors should be wood,
concrete or ceramic tile. If
floors are covered with
synthetic material, the
relative humidity should be
at least 30%.
Electrical fast transient/
burst
EN 61000-4-4
±2 kV for power-supply
lines
±1 kV for input/output
lines
±2 kV for
power-supply lines
±1 kV for input/
output lines
Mains power quality should
be that of a typical
commercial or hospital
environment.
Surge
EN 61000-4-5
±1 kV line(s) to line(s)
±1 kV line(s) to
line(s)
Mains power quality should
be that of a typical
commercial or hospital
environment.
2-14
Vscan Extend – User Manual
5721203-100 Rev. D
Important safety considerations
Table 2-2:
Electromagnetic immunity (Part 1) (Continued)
Guidance and manufacturer’s declaration – electromagnetic immunity.
The Vscan Extend is intended for use in the electromagnetic environment below. The
customer or the user of the Vscan Extend should assure that it is used in such an
environment.
EN 60601
test level
Immunity test
Compliance level
Electromagnetic
environment –
guidance
Voltage dips, short
interruptions and
voltage variations on
power supply input lines
EN 61000-4-11
5% UT (>95% dip in
UT) for 0,5 cycle
40% UT
(60% dip in UT) for 5
cycles
70% UT (30% dip in
UT) for 25 cycles
< 5% UT (>95% dip in
UT) for 5 s
5% UT (>95% dip in
UT) for 0,5 cycle
40% UT
(60% dip in UT) for 5
cycles
70% UT (30% dip in
UT) for 25 cycles
< 5% UT (>95% dip
in UT) for 5 s
Mains power quality should
be that of a typical
commercial or hospital
environment. If the user of
the ultrasound unit requires
continued operation during
power mains interruptions, it
is recommended that the
ultrasound unit is powered
from an uninterruptible
power supply or a battery.
Power frequency (50/
60 Hz) magnetic field
3 A/m
3 A/m
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.
EN/IEC 61000-4-8
NOTE: UT is the a. c. mains voltage prior to application of the test level.
Vscan Extend – User Manual
5721203-100 Rev. D
2-15
Safety
Electromagnetic immunity (continued)
Table 2-3:
Electromagnetic immunity (Part 2)
Guidance and manufacturer’s declaration – electromagnetic immunity – for all medical
electrical equipment and medical electrical systems that not life-supporting
The Vscan Extend is intended for use in the electromagnetic environment below. The
customer or the user of the Vscan Extend should assure that it is used in such an
environment.
Immunity test
IEC 60601 test
level
Complianc
e level
Conducted RF
EN 61000-4-6
3 Vrms
150 kHz to 80 MHz
3V
Radiated RF
EN 61000-4-3
3 V/m
80 Mhz to 2,5 GHz
3 V/m
Electromagnetic
environment – guidancec
Portable and mobile RF communications
equipment should be used no closer to any
part of the ultrasound unit, including cables,
than the recommended separation distance
calculated from the equation applicable to
the frequency of the transmitter.
Recommended separation distance
80 MHz to 800 MHz
800 MHz to 2.5 GHz
where p is the maximum output power rating
of the transmitter in watts (W) according to
the transmitter manufacturer and d is the
recommended separation distance in metres
(m).
Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
survey,a should be less than the compliance
level in each frequency range.b
Interference may occur in the vicinity of
equipment marked with the following symbol
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
2-16
Vscan Extend – User Manual
5721203-100 Rev. D
Important safety considerations
Table 2-3:
Electromagnetic immunity (Part 2) (Continued)
Guidance and manufacturer’s declaration – electromagnetic immunity – for all medical
electrical equipment and medical electrical systems that not life-supporting
The Vscan Extend is intended for use in the electromagnetic environment below. The
customer or the user of the Vscan Extend should assure that it is used in such an
environment.
Immunity test
IEC 60601 test
level
Complianc
e level
Electromagnetic
environment – guidancec
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and
land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the location in which the
ultrasound unit is used exceeds the applicable RF compliance level above, the ultrasound unit should be
observed to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as re-orienting or relocating the ultrasound unit.
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Vscan Extend – User Manual
5721203-100 Rev. D
2-17
Safety
Separation distances
Table 2-4:
Separation distances
Recommended separation distances between portable and mobile RF communications
equipment and the ultrasound unit
The ultrasound unit is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the ultrasound unit can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the ultrasound unit as recommended below, according to the
maximum output power of the communications equipment.
Separation distance according to frequency of transmitter (m)
Rated maximum output
of transmitter W
150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2,5 GHz
0,01
0,12
0,12
0,23
0,1
0,38
0,38
0,73
1,2
1,2
2,3
10
3,8
3,8
7,3
100
12
12
23
For transmitters rated at a maximum output power not listed above the recommended separation distance d
in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is
the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
Essential Performance
The essential performance of the Vscan Extend is:
2-18
•
The ability to display physiological images as input for
diagnosis by qualified and trained healthcare professionals.
•
The ability to display quantified data as input for diagnosis
by qualified and trained healthcare professionals.
•
The display of ultrasound indexes as aid for safe use of the
Vscan Extend.
Vscan Extend – User Manual
5721203-100 Rev. D
Important safety considerations
Acoustic output
Definition of the acoustic output parameters
Thermal Index
TI is an estimate of the temperature increase of soft tissue or
bone. There are three thermal index categories:
•
TIS: Soft tissue thermal index. The main TI category. Used
for applications that do not image bone.
•
TIB: Bone thermal index (bone located in a focal region).
Used for fetal application.
•
TIC: Cranial bone thermal index (bone located close to the
surface). Used for transcranial application.
Reference to calculation of TI can be found in:
•
NEMA Standards Publication UD 3: “Standard for Real-Time
Display of Thermal and Mechanical Acoustic Output Indices
on Diagnostic Ultrasound Equipment”, Revision 2
•
EN/IEC 60601-2-37. Medical electrical equipment.
Part 2-37: Particular requirements for the safety of
ultrasonic medical diagnostic and monitoring equipment
Mechanical Index
MI is the estimated likelihood of tissue damage due to cavitation.
The absolute maximum limits of the MI is 1.9 as set by the FDA
guidance of September 9, 2008 for diagnostic ultrasound
systems and transducers.
Ispta
The Ispta is the Spatial Peak Temporal Average Intensity. The
absolute maximum limit of Ispta is 720 mW/cm2 as set by the
FDA guidance of September 9, 2008 for diagnostic ultrasound
systems and transducers.
Vscan Extend – User Manual
5721203-100 Rev. D
2-19
Safety
Acoustic output and display on Vscan Extend
MI and TI values are displayed on the scanning screen.
The maximum possible MI and Ispta on the Vscan Extend is
within the limits set in Track 3 in the FDA guidance of
September 9, 2008 for diagnostic ultrasound systems and
transducers, MI <1.9 and Ispta <720 mW/cm2.
Display Accuracy and Acoustic Measurement Uncertainties
The display accuracy and measurement precision of the output
display are summarized in the table below. Accuracy of the
output display (TI, MI) parameters depends on the
measurement system precision, the acoustic model used to
calculate the parameters and variation in the acoustic output of
probes and systems. The measurement precision and overall
accuracy of the measurements have been assessed by
determining both the random and the systematic uncertainties
and given in percent at 95% confidence level.
Table 2-5:
Display accuracy
Estimated accuracya
Parameter
Measurement precision
black and white/color
Pressure, MI
±25%
±15%
Power, TI
±50%
±40%
a. Accuracy = (Measured value - displayed value)/displayed
value * 100%
2-20
Vscan Extend – User Manual
5721203-100 Rev. D
Important safety considerations
System controls affecting acoustic output
The operator controls that directly affect the acoustic output are
discussed in the Acoustic Output Data Tables (See ‘Acoustic
Output Reporting Tables’ on page 7-3 for more information.).
These tables show the highest possible acoustic intensity for a
given mode, obtainable only when the maximum combination of
control settings is selected. Most settings result in a much lower
output. It is important to note the following:
•
The duration of an ultrasound examination is as important
as the acoustic output, since patient exposure to output is
directly related to the exposure time.
•
Controls can help to reduce patient exposure, even though it
may not directly affect acoustic output.
The British Medical Ultrasound Society has suggested some
maximum scanning times relative to displayed TI as follows:
Table 2-6:
Obstetric scanning
TI
Maximum scanning times
General Abdominal, *Peripheral
Vascular, Adult cephalic,
Musculoskeletal, cardiac and other
scanning
time
TI
time
0.0–0.7
Unlimited
0.0–1.0
Unlimited
0.7–1.0
< 60 min
1.0–1.5
< 120 min
1.0–1.5
< 30 min
1.5–2.0
< 60 min
1.5–2.0
< 15 min
2.0–2.5
< 15 min
2.0–2.5
< 4 min
2.5–3.0
< 4 min
2.5–3.0
< 1 min
Note
Monitor TI
*Peripheral vascular is applicable for only dual probe
References
• The British Medical Ultrasound Society. Guidelines for the safe use of diagnostic ultrasound equipment.
• American Institute of Ultrasound in Medicine Consensus Report on Potential Bioeffects of Diagnostic
Ultrasound.
Vscan Extend – User Manual
5721203-100 Rev. D
2-21
Safety
Application selection
Selecting the application appropriate to a particular ultrasound
examination automatically provides acoustic output limits within
FDA guidances for that application. Other parameters which
optimize performance for the selected application are also set
automatically, and should assist in reducing the patient
exposure time.
Changing imaging modes
Acoustic output depends on the imaging mode selected. This
greatly affects the energy absorbed by the tissue (see ‘Acoustic
Output Reporting Tables’ on page 7-3 for TI and MI values in
black and white or color imaging).
ALARA
Ultrasound procedures should be performed using output levels
and exposure times As Low Reasonably Achievable (ALARA)
while acquiring clinical information.
During a diagnostic ultrasound examination, high frequency
sound penetrates and interacts with tissue in and around the
area of anatomy to be imaged. Only a small portion of the sound
energy is reflected back to the probe for use in constructing the
image while the remainder is dissipated within the tissue. The
interaction of sound energy with tissue at sufficiently high levels
can produce biological effects (aka bioeffects) of either a
mechanical or thermal nature. Bioeffect is generally undesired in
diagnostic application and may be harmful in some conditions.
ALARA training is provided in the Medical Ultrasound Safety
booklet, published by AIUM (American Institute of Ultrasound in
Medicine) provided on the Documentation CD. The ALARA
education program for the clinical end-user covers basic
ultrasound principles, possible biological effects, the derivation
and meaning of the indices, ALARA principles, and examples of
specific applications of the ALARA principle.
2-22
Vscan Extend – User Manual
5721203-100 Rev. D
Important safety considerations
ALARA (continued)
To contact the AIUM concerning their publications:
•
In the USA, by telephone at 1-800-638-5352
•
To write them, use the following address:
AIUM
14750 Sweitzer Lane
Suite 100
Laurel, MD, USA 20707-5906
In addition, the sections ‘Acoustic output and display on Vscan
Extend’ on page 2-20 and ‘System controls affecting acoustic
output’ on page 2-21 should be studied carefully in order to
implement ALARA.
Training
During each ultrasound examination the user is expected to
weigh the medical benefit of the diagnostic information that
would be obtained against the risk of potential harmful effects.
Once a diagnostic image is achieved, prolonging the exposure
cannot be justified. It is recommended that all users receive
proper training in applications before performing them in a
clinical setting.
Environmental protection
System disposal
The equipment must not be disposed of as unsorted municipal
waste nor be destroyed by incineration.
It must be collected separately. Please contact an authorized
representative of the manufacturer for information concerning
the decommissioning of your equipment.
Vscan Extend – User Manual
5721203-100 Rev. D
2-23
Safety
Maximum probe temperature
The table below indicates the maximum probe temperature.
Table 2-7:
Maximum probe temperature
Max Temp in deg C
(Simulated use)
Probe
Max Temp in deg C
(Still air)
Vscan Extend – configured with Sector probe:
Phased array transducer (G3S) for Deep scanning
39.7
43.1
Vscan Extend – configured with Dual probe:
Phased array transducer (G3S) for Deep scanning
41
42.6
Vscan Extend – configured with Dual probe:
Linear array transducer (G8L) allowing shallow
scanning
39.1
42.3
NOTE:
Measurement uncertainty and probe variation: 2 °C.
NOTE:
Lens temperature measured under following conditions per EN/
IEC 60601-2-37:
•
Thermocouple was placed at the geometric center of the
lens.
•
Thermal phantom at 33 °C (or 23 °C) for external probes.
(Temperature rise is measured and added to 33 °C if the
phantom is at 23 °C).
NOTE:
Thermal phantom made with tissue-mimicking material as
referenced in EN/IEC 60601-2-37.
•
2-24
Probe placed upright in contact with above thermal
phantom.
•
Auto-freeze capability is disabled.
•
Lens temperature is monitored for 30 minutes.
Vscan Extend – User Manual
5721203-100 Rev. D
Device labels and symbols
Device labels and symbols
Vscan Extend Labels (Example)
Figure 2-2.
1.
2.
3.
4.
NOTE:
Vscan Extend rating label
Rating label
Inner label
UDI label - contains UDI information
Serial number label - contains device serial number
The label shown in Figure 2-2 is a sample. The label varies
country to country based on country requirements.
Vscan Extend – User Manual
5721203-100 Rev. D
2-25
Safety
Vscan Extend Labels (Example) (continued)
Figure 2-3.
Figure 2-4.
Figure 2-5.
2-26
Vscan Extend battery label
Vscan Extend AC/DC adapter label
Vscan Extend external battery charger label
Vscan Extend – User Manual
5721203-100 Rev. D
Device labels and symbols
Vscan Extend Labels (Example) (continued)
The following table describes the purpose of safety labels and
other important information provided on the equipment.
Table 2-8:
Label
Label Icons
Purpose
Location
CE mark
• Vscan Extend system
• Vscan Extend External
Battery charger
This symbol indicates that the waste of
electrical and electronic equipment must
not be disposed as unsorted municipal
waste and must be collected separately.
Please contact the manufacturer or other
authorized disposal company to
decommission your equipment.
• Vscan Extend system
• Vscan Extend battery
• Vscan Extend External
battery charger
Follow instructions for use. Read and
understand all instructions in the User's
Manual before attempting to use the
ultrasound unit.
• Vscan Extend system
• Vscan Extend External
Battery charger
TÜV mark
Vscan Extend system
Prescription device statement for the USA
only:
Caution: Federal law restricts this device to
sale by or on the order of a physician.
Vscan Extend system
Type BF Applied Part symbol (see
‘Classifications’ on page i-5)
Vscan Extend system
Keep dry
Vscan Extend system
Input, use only Vscan Extend charger.
Vscan Extend system
Vscan Extend External Battery
charger
Rechargeable, use only Vscan Extend
battery.
Vscan Extend system
Vscan Extend External Battery
charger
Input to Vscan Extend battery
Vscan Extend External Battery
charger
Vscan Extend – User Manual
5721203-100 Rev. D
2-27
Safety
Table 2-8:
Label
Assembled in Romania
(Romania is a country
name)
NOTE:
2-28
Label Icons (Continued)
Purpose
Location
Manufacturer name and address
• Vscan Extend system
• Vscan Extend External
Battery charger
Manufacturing date (year-month)
• Vscan Extend system
• Vscan Extend External
Battery charger
Part number
• Vscan Extend system
• Vscan Extend External
Battery charger
Serial number
• Vscan Extend system
• Vscan Extend External
Battery charger
Unique Device Identification (UDI). Every
system has a unique marking for
identification. Scan or enter the UDI
information into the patient health record
according to governing laws.
Vscan Extend system
Refer label inside
Vscan Extend system
Identify the customs country of origin of the
materials.
Vscan Extend system
Push button (power switch)
Vscan Extend system
As a safety precaution, scanning is not possible when charging
the battery.
Vscan Extend – User Manual
5721203-100 Rev. D
Device labels and symbols
Explanation of the Pollution control label for China
The following product pollution control information is provided
according to SJ/T11364-2014 Marking for Restriction of
Hazardous Substances caused by electrical and electronic
products
Table 2-9:
Label for China
Label
Description
This symbol indicates the product contains hazardous materials in excess of
the limits established by the Chinese standard GB/T 26572 Requirements of
concentration limits for certain restricted substances in electrical and
electronic products. The number in the symbol is the Environment-friendly
Use Period (EFUP), which indicates the period during which the hazardous
substances contained in electrical and electronic products will not leak or
mutate under normal operating conditions so that the use of such electrical
and electronic products will not result in any severe environmental pollution,
any bodily injury or damage to any assets. The unit of the period is “Year”.
In order to maintain the declared EFUP, the product shall be operated
normally according to the instructions and environmental conditions as
defined in the product manual, and periodic maintenance schedules
specified in Product Maintenance Procedures shall be followed strictly.
Consumables or certain parts may have their own label with an EFUP value
less than the product. Periodic replacement of those consumables or parts
to maintain the declared EFUP shall be done in accordance with the
Product Maintenance Procedures.
This product must not be disposed of as unsorted municipal waste, and
must be collected separately and handled properly after decommissioning.
Table 2-10:
Hazardous substances
Hazardous Substances' Name
Component Name
Pb
Hg
Cr6+
Cd
PBB
PBDE
Probe & Cable
Main unit
O: Indicates that hazardous substance contained in all of the homogeneous materials for this part is below
the limit requirement in GB/T 26572.
X: Indicates that hazardous substance contained in at least one of the homogeneous materials used for this
part is above the limit requirement in GB/T 26572.
• Data listed in the table represents best information available at the time of publication.
• Applications of hazardous substances in this medical device are required to achieve its intended clinical
uses, and/or to provide better protection to human beings and/or to environment, due to lack of reasonably
(economically or technically) available substitutes.
Vscan Extend – User Manual
5721203-100 Rev. D
2-29
Safety
2-30
Vscan Extend – User Manual
5721203-100 Rev. D
Chapter 3
Preparing Vscan Extend for
Use
Contents:
‘Package contents’ on page 3-2
‘System description’ on page 3-4
‘Battery’ on page 3-15
‘First time use’ on page 3-22
‘Activation’ on page 3-24
Vscan Extend – User Manual
5721203-100 Rev. D
3-1
Preparing Vscan Extend for Use
Package contents
Vscan Extend package contents
Make sure all items listed below are included in the package.
Figure 3-1.
Vscan Extend package contents
1. Vscan Extend softcase with
device and probe
2. USB cable
3. Gel bottle location
Table 3-1:
Item
4. Region-specific plugs
5. AC/DC adapter
6. Battery
Package content
Description
Vscan Extend Quick Card
Vscan Extend User Manual
Service contact information
3-2
Vscan Extend – User Manual
5721203-100 Rev. D
Environmental requirements
Environmental requirements
Environmental requirements for the device
Description
Table 3-2:
Environmental requirements
Operational
Non operational
Storage and transport
Temperature
0 °C to + 40 °C
- 40 °C to + 70 °C
- 40 °C to + 70 °C
Humidity
90%, non-condensing
15–90%
90%, non-condensing
Air pressure
620 hPa to 1060 hPa
620 hPa to 1060 hPa
620 hPa to 1060 hPa
Transient operating conditions
NOTE:
NOTE:
Permissible transient environmental operating conditions:
•
Temperature range of 0-40 degrees
•
Relative humidity range of 15 to 90% non-condensing
Avoid exposing the unit to saline moisture. In case of exposure
to saline moisture, clean the unit as described on ‘Cleaning and
disinfection’ on page 6-4.
Refer to Table 3-2 above for additional information regarding
storage of the battery.
Image display on the Vscan Extend is dependent on ambient
light; avoid direct sunlight or reflections from other light sources
on the display when scanning and reviewing images. The
display viewing angle should be as small as possible.
If you are having difficulty seeing the image due to the lighting
conditions try to change brightness (see ‘Scan Settings’ on
page 4-2) or change your position/location of use.
The time required for the Vscan Extend to warm from minimum
storage between uses until the device is ready for use at 20
degrees ambient is approximately 1 minute.
The time required for the Vscan Extend to cool from minimum
storage between uses until the device is ready for use at 20
degrees ambient is approximately 1 minute.
The Vscan Extend is transportable in a road ambulance or fixed
/rotary wing aircraft.
Vscan Extend – User Manual
5721203-100 Rev. D
3-3
Preparing Vscan Extend for Use
System description
System overview
Vscan Extend configured with a Sector probe for deep scanning
Figure 3-2.
1. Display
2. Sector probe
3. Serial port (For Service ONLY)
NOTE:
3-4
Vscan Extend with a Sector probe
4. Power button
5. LED indicates charging status
6. USB port and Power connector
Green LED indicates Vscan Extend is fully charged and an
amber LED indicates it is charging.
Vscan Extend – User Manual
5721203-100 Rev. D
System description
Vscan Extend configured with a Dual probe holding both a phased array
and linear array transducer for deep and shallow scanning
Figure 3-3.
1. Display
2. Dual probe
3. Serial port (For Service ONLY)
NOTE:
Vscan Extend with Dual probe
4. Power button
5. LED indicates charging status
6. USB port and Power connector
Green LED indicates Vscan Extend is fully charged and an
amber LED indicates it is charging.
Vscan Extend – User Manual
5721203-100 Rev. D
3-5
Preparing Vscan Extend for Use
Vscan Extend Dual Probe
Figure 3-4.
The dual probe
1. Phased array transducer (deep scanning)
2. Linear array transducer (shallow scanning)
3-6
Vscan Extend – User Manual
5721203-100 Rev. D
System description
Accessories and Configurations
Standard and optional accessories
Table 3-3:
Standard accessories
Accessory
Figure
1. Global AC adapter with
interchangeable region-specific
plugs
2. One rechargeable battery
3. USB cable
4. MicroSD memory card (For
service personnel only. Not for
customer use.*)
5. Soft case
6. User Manual
7. Hardcopy Quick Card
* The microSD card provided in the device captures error logs
and is strictly for Service personnel only. The user must
remove this microSD card and insert a blank one when
performing data backup. The microSD card that captures error
log files is used for troubleshooting by the Repair Depot.
** Not available in all countries
Vscan Extend – User Manual
5721203-100 Rev. D
3-7
Preparing Vscan Extend for Use
Table 3-3:
Standard accessories
Accessory
Figure
**
8. Gel (60g bottle)
* The microSD card provided in the device captures error logs
and is strictly for Service personnel only. The user must
remove this microSD card and insert a blank one when
performing data backup. The microSD card that captures error
log files is used for troubleshooting by the Repair Depot.
** Not available in all countries
3-8
Vscan Extend – User Manual
5721203-100 Rev. D
System description
Standard and optional accessories (continued)
Table 3-4:
Optional accessories
Accessory
Figure
1. Additional Soft case
2. Robust case to carry
complete Vscan Extend set
3. Robust case to carry only
scanner, gel, and potential
extra battery
4. External Battery charger
5. Additional Battery
6. Additional AC adapter
7. Hardcopy User manual
Vscan Extend – User Manual
5721203-100 Rev. D
3-9
Preparing Vscan Extend for Use
Connectivity Configurations
Vscan Extend is available in three different connectivity
configurations:
1. USB configuration
2. Wi-Fi Access configuration
3. DICOM configuration
The table below describes the standard and connectivity
configurations.
Table 3-5:
Description
Configurations
USB
configuration
Wi-Fi Access
configuration
DICOM
configuration
Generic image format (jpg, mp4) for
data stored on device or exported to PC
Image transfer to PC via USB cable
Manual labeling of exam data with
patient ID
FIPS compliant data encryption
Data backup capability on microSD card
Wireless image transfer to shared
network folders
Enterprise grade wireless encryption
standards including EAP and WPA2
(PSK)
Mobile Device Management client
support
Access to GE marketplace to selectively download and install Vscan Extend apps
Bladder Volume
Lung Protocol
Tricefy Uplink
Wireless reading DICOM Modality
Worklist
Wireless image export in DICOM format
Access to reference materials on Vscan
web portal
* The Vscan Extend app represents only the interface to the cloud-based case
exchange solution which is separately provided by GE
A: Available
3-10
Blank cells indicates: Not Available
Vscan Extend – User Manual
5721203-100 Rev. D
System description
External battery charger compartment (option)
The external battery charger compartment is used to charge the
battery outside the Vscan Extend.
NOTE:
The Vscan Extend battery can either be charged in the main unit
by directly plugging the AC/DC adapter or externally by placing
the Vscan Extend battery on the external battery charger.
NOTE:
Scanning is disabled during charging if charged in the main unit.
Figure 3-5.
External battery charger compartment
The table below lists the units or parts that can be replaced by
the user (CRU - Customer Replacable units)
Table 3-6:
Description
CRU
Part number
Battery
5693456
AC/DC adapter
5693487
Application Software SD
Card
5716858
External Battery Charger
5716861
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5721203-100 Rev. D
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Preparing Vscan Extend for Use
Display screens
Figure 3-6.
Scanning screens (Black and white mode)
Phased array transducer
1. Header
• Menu icon
• Patient information
• Exam number
• Battery level indicator
• MI and TI values
2. Depth scale
3. Footer
• Color icon
• Gain
• Depth
• Store
NOTE:
3-12
Linear array transducer
1. Header
• Menu icon
• Patient information
• Exam number
• Battery level indicator
• MI and TI values
2. Depth scale
3. Footer
• Color icon
• Gain
• Depth
• Store
The screen graphics in this manual are only for illustrational
purposes. Actual screen output or graphics may vary.
Vscan Extend – User Manual
5721203-100 Rev. D
System description
Display screens (continued)
Figure 3-7. Scanning screens (Color mode)
Phased array transducer
1. Header
• Menu icon
• Patient information
• Exam number
• Battery level indicator
• MI and TI values
2. Depth scale
3. Footer
• Color icon
• Gain
• Depth
• Store
4. Color bar
5. Color ROI (Region of Interest)
Vscan Extend – User Manual
5721203-100 Rev. D
Linear array transducer
1. Header
• Menu icon
• Patient information
• Exam number
• Battery level indicator
• MI and TI values
2. Depth scale
3. Footer
• Color icon
• Gain
• Depth
• Store
4. Color bar
5. Color ROI (Region of Interest)
3-13
Preparing Vscan Extend for Use
Display screens (continued)
Figure 3-8.
3-14
Menu screen
Vscan Extend – User Manual
5721203-100 Rev. D
Vscan Extend Battery
Vscan Extend Battery
Battery
The Vscan Extend system is powered by a Li ION battery
(Model - U80395). The battery is not fully charged prior to
shipment. To maximize time of use, it is recommended to
recharge the battery before use for at least 1.5 hours. Establish
a routine for charging the battery to maximize system
availability.
The battery must be charged while housed in the Vscan Extend
or in the external battery charger.
The Li ION battery, used in Vscan Extend, with the battery code
is displayed below.
Figure 3-9.
Vscan Extend battery
Battery specification
Table 3-7:
Battery specification
Items
Basic
Vscan Extend – User Manual
5721203-100 Rev. D
Unit
Value
Description
Voltage
mV
7400
MAX
Current
mA
1150
Avg 1C
3-15
Preparing Vscan Extend for Use
Battery (continued)
WARNING
Use only the AC adapter provided with the Vscan Extend.
The Vscan Extend cannot be charged via the USB cable when
connected to a PC.
Figure 3-10.
CAUTION
Vscan Extend AC adapter
The AC adapter must be kept outside the patient environment
(refer to local regulation and EN 60601-1).
Figure 3-11.
Patient environment
1. Patient environment
WARNING
3-16
Do NOT simultaneously touch the patient and the charger plug
on the AC adapter.
Vscan Extend – User Manual
5721203-100 Rev. D
Vscan Extend Battery
Power plugs
1. Select the country specific plug.
Figure 3-12. Power plugs
1. North America, Japan
2. China
3. Australia, New Zealand
4. UK, Hong Kong, Singapore
5. Continental Europe and Korea
(for unearthed electrical outlet)
2. Insert the relevant plug into the adapter.
Figure 3-13.
Insert the plug
Voltage requirements
The AC/DC adapter will function on voltage from 100 to
240 VAC and 50/60 Hz.
CAUTION
Only use mains power of 100 – 240 VAC. Voltage outside this
range can cause a malfunction or destroy the AC/DC adapter.
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5721203-100 Rev. D
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Preparing Vscan Extend for Use
Charging the battery
1. Insert the battery into the device.
Figure 3-14.
Insert the battery
2. Plug the AC/DC adapter into the electrical outlet.
Charging the battery using the optional External battery charger
compartment
1. Place the external battery charger on a flat surface.
2. Insert the battery in the compartment.
NOTE:
Do not apply excessive pressure to the battery while
inserting it into the compartment. There is no snap provided
on the external battery charger. The battery fits smoothly
into the compartment without a click.
3. Plug the charger plug into the charger connector on the
external battery charging compartment.
3-18
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5721203-100 Rev. D
Vscan Extend Battery
Battery level indicator
The battery level indicator is displayed on the screen. The
following icons are displayed.
Table 3-8:
Battery level indicator
Icon
Description
Battery fully charged (>=95%).
Battery 75% charged (>=70% and <95%).
Battery 50% charged (>=45% and <70%).
Battery critical, or low Battery (<45%).
Prepare to recharge the battery or have a spare battery
available.
Battery charging.
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5721203-100 Rev. D
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Preparing Vscan Extend for Use
Inserting/removing the battery
To insert the battery
1. Insert the battery in the compartment until the lid clicks in
place.
Figure 3-15.
Inserting battery
To remove the battery
1. Power off the Vscan Extend.
CAUTION
Do not attempt to remove the battery without powering off
the Vscan Extend.
2. Push the button on the battery compartment lid and lift the
battery.
Figure 3-16.
3-20
Removing battery
Vscan Extend – User Manual
5721203-100 Rev. D
Vscan Extend Battery
Battery specifications
Table 3-9:
Battery specification
Item
Specification
Charging time at 90%
About 75 minutes
Capacity
About 1 hour while continuously scanning
Lifetime
At least 300 charges
In order to get maximum charging capacity with your Vscan
Extend battery, you should initially allow the battery to be fully
charged and then fully discharged at least three times. Perform
normal operation during these cycles. Once the initial charging/
discharging cycles are performed, the following is applicable
without reducing the lifetime of the battery:
•
It is not necessary to completely discharge the battery
before re-charging.
•
It is possible to stop charging the battery before it is fully
charged, but the battery will then be discharged more
rapidly.
•
It is possible to charge the battery several times each day, if
needed.
When storing the Vscan Extend for a period longer than three
months, remove the battery from the Vscan Extend main unit.
Recharge the battery every three months to maintain battery
performance. When the battery is stored separately, storage can
be at least one year before recharging the battery is needed.
NOTE:
Make sure to remove the battery from the device before
shipping from one place to another.
To minimize battery performance degradation, avoid prolonged
storage of the battery outside the Vscan Extend operational
temperature range (see ‘Environmental requirements for the
device’ on page 3-3).
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5721203-100 Rev. D
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Preparing Vscan Extend for Use
Initial use
First time use
Before Vscan Extend can be used, the following steps must be
done:
1. Install the battery. (See ‘To insert the battery’ on page 3-20
for more information.)
2. Press the Power button to power on Vscan Extend.
3. Activate Vscan Extend. (See ‘Vscan Extend activation’ on
page 3-24 for more information.)
Power on/off
To power on the Vscan Extend
Press the Power button.
Device boots up and scan screen displays within 45 seconds.
NOTE:
The Scan screen displays only when the device has been
activated. See ‘Activation’ on page 3-24 for more information.
To power off the Vscan Extend
1. Press the Power button.
A pop-up displays prompting to Power off OR Restart.
2. Select Power off.
3-22
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5721203-100 Rev. D
Initial use
To restart Vscan Extend
1. Press and hold the Power button.
2. Select Restart to restart the device.
Standby Mode
Vscan Extend enters standby mode when the Power button is
quickly pushed. In this mode, Vscan Extend will not have power
to the probe or any display.
OR
Vscan Extend enters standby mode automatically while in
freeze mode for more than 10 minutes.
Push the Power button again once to resume from standby
mode. The device is ready to scan within a second.
NOTE:
When resuming the device from standby mode, a new exam is
created and the previous exam data is lost, if not previously
saved.
Sleep Mode
Vscan Extend enters sleep mode if it continues to be in standby
mode for more than 3 hours.
Push the Power button again to resume from sleep mode. The
device is ready to scan within approximately 5 seconds.
NOTE:
When resuming the device from sleep mode, a new exam is
created and the previous exam data is lost, if not previously
saved.
Startup procedure
The approximate time taken for the device from switching on
until the device is ready for normal use is 40 seconds.
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5721203-100 Rev. D
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Preparing Vscan Extend for Use
Vscan Extend activation
Activation
There are three possible scenarios to activate Vscan Extend:
1. Scenario 1: Activation using Wi-Fi on the Vscan Extend
device.
2. Scenario 2: Manual activation - activate Vscan Extend by
visiting the url: https://vscanactive.gehealthcare.com from a
PC.
3. Scenario 3: Activation without internet access. If there is no
internet access, contact GE Service (see page 1-8 for
phone numbers, then see ‘Offline activation’ on page 4-12)
to activate Vscan Extend.
Activation using Wi-Fi
The activation process includes steps to register the Vscan
Extend device.
NOTE:
3-24
When Wi-Fi is enabled the device can be activated directly.
Vscan Extend – User Manual
5721203-100 Rev. D
Initial use
Set Language, Date and Time
1. Connect Vscan Extend to a power source.
2. Press the Power button to power on Vscan Extend.
The Startup screen displays, followed by the Language
screen.
NOTE:
The default language is set to English.
3. To choose another language, press Change Language.
Figure 3-17.
Select language
4. Choose the desired language. The screen changes back to
the Language screen.
5. Press Next.
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5721203-100 Rev. D
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Preparing Vscan Extend for Use
Set Language, Date and Time (continued)
6. The Date and Time screen displays.
NOTE:
The current date and time is set by default.
7. Press Change Date and Time to change the date and time,
if needed.
Figure 3-18.
Date and Time
Choose either the automatic date and time format which
sets the date and time by synchronizing through the
internet.
OR
Set the date and time manually.
8. Press Next.
3-26
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5721203-100 Rev. D
Initial use
Connecting Wi-Fi
NOTE:
If Wi-Fi is not detected, configure Wi-Fi. See ‘Configuring Wi-Fi’
on page 4-23 for more information.
1. Select your Wi-Fi network and enter your Wi-Fi password.
(All non hidden Wi-Fi networks are displayed.)
Figure 3-19.
Wi-Fi settings
2. Press Next.
NOTE:
Ensure that the Vscan Extend is connected to a non-clinical
Wi-Fi hotspot to start activation.
NOTE:
A non-clinical Wi-Fi has access to the public internet, which is
not part of the hospital internet. If you are unable to view the
non-clinical Wi-Fi or do not have the password, contact your
system administrator.
NOTE:
If you do not have access to public Wi-Fi, proceed with manual
activation of the device. See ‘Manual activation’ on page 3-35
for more information.
NOTE:
If the hospital network does not have an internet connection,
proceed with manual activation of the device. See ‘Manual
activation’ on page 3-35 for more information.
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5721203-100 Rev. D
3-27
Preparing Vscan Extend for Use
Connecting Wi-Fi (continued)
1. Enter the authentication details to connect to the network.
Figure 3-20.
Authentication code
2. Once the device connects to the network, press the Back
arrow to exit the Settings screen.
The screen changes back to the Wi-Fi screen (Figure 3-19
on page 3-27.)
3. Press Next.
3-28
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5721203-100 Rev. D
Initial use
Registration
Registering the device creates a Vscan Extend account which
enables access to the GE Marketplace and other features.
First time registrants
1. First time registrants, press Register to create an account.
Enter the required details.
Figure 3-21.
NOTE:
HINTS
Registration details
If you have previously registered a Vscan Extend device,
press Already Registered using your registered email. See
‘Registered users’ on page 3-31 for more information.
Press the Arrow key twice to get the letters in all caps and
press the number key to toggle between numbers and
alphabet.
Figure 3-22.
Vscan Extend – User Manual
5721203-100 Rev. D
Keyboard tips
3-29
Preparing Vscan Extend for Use
First time registrants (continued)
2. Check the desired options to either participate in
collaborative GE activities or to receive special offers and
promotions.
Press Register.
3. An email is sent to the email address used during
registration.
NOTE:
The email has a link requiring you to change your password
for security purposes.
4. Press Activate my device.
Figure 3-23.
Choose an option
5. Vscan Extend has been activated. Press Start Using
Device.
Figure 3-24.
3-30
Start using Vscan Extend
Vscan Extend – User Manual
5721203-100 Rev. D
Initial use
Registered users
NOTE:
Ensure Vscan Extend is connected to a non-clinical Wi-Fi.
1. Press Already Registered.
2. Enter your email ID and password.
Figure 3-25.
NOTE:
Already Registered
If you log in with a wrong email ID, a pop-up message
displays: “Login error: Your email ID is not confirmed yet”.
Try again with a valid email ID.
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5721203-100 Rev. D
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Preparing Vscan Extend for Use
Registered users (continued)
3. While the activation process is in progress, the wireless is
connecting to the GE Store and the activation key is being
entered automatically.
4. Press Activate my device.
5. Vscan Extend has been activated. Start using the device.
Figure 3-26.
3-32
Start using Vscan Extend
Vscan Extend – User Manual
5721203-100 Rev. D
Initial use
Already registered users - Forgot password
1. If you forgot your password, press Forgot Password.
2. An email is sent to your confirmed email address with a link
to reset the password.
Figure 3-27.
Forgot password
3. Click on the link on a personal computer to reset the
password.
4. Enter your email ID and new password. The Vscan Extend
is activated and ready to use.
Figure 3-28.
Reset password and start using Vscan Extend
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5721203-100 Rev. D
3-33
Preparing Vscan Extend for Use
Network access failed
1. If you are unable to connect to a Wi-Fi network, press Retry
and try to activate the device again.
Figure 3-29.
Retry
2. If the problem persists, contact your internet service
provider and GE at help@gehc.com to connect to the
network.
3. If the network is not accessible or you are unable to connect
to the network, you can activate Vscan Extend manually.
See ‘Manual activation’ on page 3-35 for more information.
3-34
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5721203-100 Rev. D
Initial use
Manual activation
To activate Vscan Extend without Wi-Fi connection, follow the
steps below.
1. Open the URL (https://vscanactive.gehealthcare.com) in the
internet browser on your PC.
NOTE:
The PC should have internet access. If there is no internet
access, call GE Service center or contact your local Sales
representative.
2. Follow the directions provided on the site to generate the
activation key for Vscan Extend.
The following information is required:
•
The Vscan Extend serial number written on the rear
label of the system.
3. User information as per the figure below.
Figure 3-30.
User Information
4. Enter other necessary details.
Figure 3-31.
Figure 3-32.
Vscan Extend – User Manual
5721203-100 Rev. D
Opt-in checkbox
Opt-in communication
3-35
Preparing Vscan Extend for Use
Manual activation (continued)
5. Press Submit to initiate registration.
Figure 3-33.
Submit
6. The Activation key is generated. Store the key in a
convenient location to enter into the device and for future
reference.
Figure 3-34.
3-36
Activation key details
Vscan Extend – User Manual
5721203-100 Rev. D
Initial use
Activation key
The Activation key screen is displayed on the Vscan Extend.
1. Enter the activation key generated while registering on the
portal (https://vscanactive.gehealthcare.com)
Figure 3-35.
HINTS
Enter activation key
Press the Backspace key if a mistake occurred while entering
the activation key.
2. Press Activate.
Figure 3-36.
Start using the device
3. Vscan Extend has been activated. Start using the device.
Vscan Extend – User Manual
5721203-100 Rev. D
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Preparing Vscan Extend for Use
3-38
Vscan Extend – User Manual
5721203-100 Rev. D
Chapter 4
Vscan Extend Settings
Contents:
‘Settings’ on page 4-2
‘Scan Settings’ on page 4-2
‘Server Settings’ on page 4-3
‘Diagnostics’ on page 4-12
‘Wi-Fi’ on page 4-21
‘MDM Installation Procedures (Optional)’ on page 4-24
‘Certificate Authority’ on page 4-28
‘GE Marketplace’ on page 4-31
Vscan Extend – User Manual
5721203-100 Rev. D
4-1
Vscan Extend Settings
Settings
The following settings and functions are available under the
main Settings menu.
Scan Settings
Press Menu -> Settings
Figure 4-1.
•
Settings
Brightness - adjusts the screen brightness of the device
Swipe the brightness level indicator to the left to decrease
the brightness and swipe to the right to increase the
brightness.
4-2
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5721203-100 Rev. D
Settings
Scan Settings (continued)
Auto Freeze (Probe) - set the auto freeze time.
1. Press Auto Freeze (Probe)
2. Choose the desired value
3. Press OK to set the value
Video Duration - set duration of the captured Cine loops.
1. Press Video Duration
2. Choose the desired value
3. Press OK to set the value
Unit of Measurement - set unit of measurement
1. Press Unit of Measurement
2. Choose the desired unit
3. Press OK to set the value
Set current preset as default
1. Press Set Current Preset as Default
2. Press Yes to set the displayed preset as default.
Server Settings
Allows to configure the DICOM servers.
Figure 4-2.
Server settings
Worklist Server - gets patient and intended study information
Image Server - remote store location for media (video/images)
DICOM Encoding - Choose the desired encoding type and press
OK.
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5721203-100 Rev. D
4-3
Vscan Extend Settings
Server Settings (continued)
To configure the Worklist server:
HINTS
Press the title bar (the entire top section on the screen) or
swipe left most side of the screen to access the Menu.
1. Press Menu -> Settings
Figure 4-3.
Settings
2. Scroll down to Server Settings. Press Worklist Server.
Figure 4-4.
4-4
Worklist server
Vscan Extend – User Manual
5721203-100 Rev. D
Settings
Configure Worklist Server
Connect Vscan Extend to the hospital wireless network. See
‘Activation using Wi-Fi’ on page 3-24 for more information.
1. Enter all fields to add a new Worklist server.
Figure 4-5.
NOTE:
Configure Worklist Server
Swipe upwards to get the full screen and enter all details.
Contact the hospital IT administrator for details.
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5721203-100 Rev. D
4-5
Vscan Extend Settings
Configure Worklist Server (continued)
NOTE:
By default, DICOM is listed while configuring the Worklist
Server.
Figure 4-6.
DICOM listed
2. Enter any unique name for Calling AE Title (e.g. Nixon
Building Schedule).
3. Press Add Server to add the Worklist Server.
4. Press Verify to verify communication with the Worklist
Server.
Figure 4-7.
4-6
Verify Worklist Server
Vscan Extend – User Manual
5721203-100 Rev. D
Settings
Configure Worklist Server (continued)
“Verify OK” pop-up displays if the communication with the
Worklist Server is ok.
If communication fails:
•
check the server settings and make necessary
corrections.
•
Vscan Extend and the DICOM image server are not
connected to the same network. Check network settings
for all components.
5. Press and hold the selected Worklist entry to add to the
favorites list. By default, the first added Worklist server is set
as the favorite. To remove a Worklist server from the
favorites list, press and hold on the server name. If you wish
to change it, press and hold to remove the current favorite
and add the preferred server.
Figure 4-8.
Add to favorites
NOTE:
If only one DICOM MWL server is configured, it is
automatically set as the favorite.
NOTE:
The scheduled exam list will automatically be pulled from
the favorite server.
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5721203-100 Rev. D
4-7
Vscan Extend Settings
Configure Worklist Server (continued)
6. To add another Worklist server, press Add (+).
Figure 4-9.
Add another Worklist server
7. To delete the Worklist Server, press the Delete icon.
Figure 4-10.
4-8
Delete Worklist
Vscan Extend – User Manual
5721203-100 Rev. D
Settings
Configure Image Server
1. Press Menu -> Settings
Figure 4-11.
Menu
2. Scroll down to Server Settings. Press Image Server.
Figure 4-12.
Vscan Extend – User Manual
5721203-100 Rev. D
Image Server
4-9
Vscan Extend Settings
Configure Image Server (continued)
3. Enter your Image server’s IP address, port number, and
Remote AE Title.
Figure 4-13.
NOTE:
Configure Image Server
Enter any unique name for Calling AE Title (e.g. Nixon
Building Image Archive). Contact the hospital IT
administrator for details.
4. Press Add Server.
4-10
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5721203-100 Rev. D
Settings
Configure Image Server (continued)
5. Press Verify to verify that the communication with the Image
Server is ok.
Figure 4-14.
Verify Image Server
“Verify OK” pop-up displays if the communication with the
Image Server is ok.
If communication fails:
•
Check the server settings and make necessary
corrections.
•
Vscan Extend and the DICOM image server are not
connected to the same network. Check network settings
for all components.
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5721203-100 Rev. D
4-11
Vscan Extend Settings
Configure Image Server (continued)
6. Press and hold the Image Server to add the selected Image
Server to favorites.
Figure 4-15.
NOTE:
Add to favorites
When you have added more than one image server, you
can set one as a favorite. Once an image server is set as a
favorite, saved images are automatically exported once
patient information is added or edited for any exam.
Diagnostics
Figure 4-16.
4-12
Diagnostics
•
System Diagnostics - Performs main board or hardware
diagnostics
•
Display Test - Perform this test if there is a problem with the
display. Use a swiping motion to navigate through all the
screens. If an issue persists, contact GE Service.
Vscan Extend – User Manual
5721203-100 Rev. D
Settings
System Settings
Figure 4-17.
WARNING
System Settings
•
Admin Settings - Change date, time and configure Wi-Fi
•
GE Marketplace - Select an app
•
Facility Name - Set Facility Name
•
Session Duration - When the device is idle, data access is
active for the duration set. The default duration is 1 hour.
The following values are available to set the duration:
•
5 min
•
15 min
•
1 hr
•
5 hrs
•
1 day
•
never
When the device is idle for the duration set, it is the
reponsibility of the user to ensure that the device is not used by
unauthorized persons as it may lead to data loss.
Vscan Extend – User Manual
5721203-100 Rev. D
4-13
Vscan Extend Settings
System Settings (continued)
•
Configuration - Choose the desired option through an option
key, either manually (enter the serial number of the device in
the portal on a PC to obtain the option key) or (if Wi-Fi is
connected, check for updates)
Figure 4-18. Configuration
Press View Modules to obtain the list of enabled modules.
Figure 4-19.
4-14
Enabled modules
•
My Account - Set User account
•
About - Provides device information
Vscan Extend – User Manual
5721203-100 Rev. D
Settings
Administrator Access
For security purposes, the user has to create an admin PIN.
This PIN provides access to the Admin settings.
1. Create a new PIN (four digit number e.g. 1234) for security
purpose.
Figure 4-20.
Create admin PIN
2. Enter the new PIN again for confirmation.
Figure 4-21.
NOTE:
Confirm new PIN
The PIN is critical to accessing system data. Avoid sharing this
PIN with non-administrators and take precautions to not lose this
PIN.
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5721203-100 Rev. D
4-15
Vscan Extend Settings
Administrator Access (continued)
The new PIN provides access to advanced settings.
Figure 4-22.
4-16
Advanced Settings
Vscan Extend – User Manual
5721203-100 Rev. D
Settings
Storage Access
A device PIN has to be created for security purposes to access
or store images/ videos. This PIN is created prior to the first use
or after the system has been reset. Once the PIN is set, the
user is prompted for the PIN every time the device is powered
ON or after the session duration time has expired.
1. Create a new PIN for data storage and access, for e.g.,
1234.
Figure 4-23.
User PIN
2. Confirm the new PIN for security purpose. Confirmation is
only required after PIN creation.
Figure 4-24.
Vscan Extend – User Manual
5721203-100 Rev. D
Confirm PIN
4-17
Vscan Extend Settings
Storage Access (continued)
A PIN security note also desplays to the user:
This PIN is critical for accessing system data. It is required
to access and store system data. Please remember a wrong
/ incorrect PIN entry can lead to loss of system data. Avoid
sharing the PIN to unauthorized users for data protection.
Figure 4-25.
Remember PIN
The new PIN provides access to data storage and retrieval
during normal use of the Vscan Extend.
Incorrect PIN
The Vscan Extend prompts to enter the PIN after power ON
or reboot. User can skip entering the PIN and continue scanning
by pressing the scan symbol at the bottom of the screen, see
Figure 4-26 on page 4-19. In this case, scanning is allowed but
images/videos cannot be stored or accessed.
4-18
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5721203-100 Rev. D
Settings
Incorrect PIN (continued)
1. A pop-up message displays when an incorrect PIN is
entered.
Figure 4-26.
Wrong PIN
2. After 5 wrong attempts, the Vscan Extend displays a pop-up
message to “Backup” data on a microSD card before the
next login. See ‘Backup’ on page 5-42 for more information.
Figure 4-27.
Vscan Extend – User Manual
5721203-100 Rev. D
Backup data
4-19
Vscan Extend Settings
Incorrect PIN (continued)
3. If backup is not performed after 5 attempts of wrong PIN
entry and once again a wrong PIN is entered, a pop-up
message displays for every incorrect PIN entry thereafter.
For e.g., 4, 3, 2, 1 attempt(s) left.
Figure 4-28.
NOTE:
Remaining attempts
It is highly recommended to back up data on a microSD card
before the last attempt.
After the 10th attempt, the system resets and returns to the
initial screen where a new pin should be entered see
Figure 4-23 on page 4-17.
4-20
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5721203-100 Rev. D
Settings
Wi-Fi
Wi-Fi is a local area wireless computer networking technology
that allows electronic devices to network.
For Wi-Fi to work on the Vscan Extend:
1. Activate Wi-Fi on the device.
2. Connect to a specific network.
Activating Wi-Fi
To activate Wi-Fi on the Vscan Extend:
1. Press Menu -> Settings -> Admin Settings.
Figure 4-29.
Admin Settings
2. Enter the Admin PIN to access advanced settings (settings
of the operating system). See ‘Administrator Access’ on
page 4-15 for more information.
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5721203-100 Rev. D
4-21
Vscan Extend Settings
Activating Wi-Fi (continued)
3. Press Settings on the Dashboard.
Figure 4-30.
4-22
Advanced Settings
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5721203-100 Rev. D
Settings
Configuring Wi-Fi
1. Press the ON/OFF button on the right to turn ON Wi-Fi.
2. Press Wi-Fi.
Figure 4-31. Menu
Choose the network if you know the credentials or contact
your system administration
Procedure to check the MAC Address
NOTE:
If the Wi-Fi network has been configured with the MAC address,
press MAC Address on the Advanced Settings screen.
Figure 4-32.
Vscan Extend – User Manual
5721203-100 Rev. D
Mac address
4-23
Vscan Extend Settings
Deleting Wi-Fi networks
1. Press Settings from the Dashboard.
2. Press Wi-Fi.
3. Select the network to be deleted.
A pop-up displays prompting you to forget or modify the
network.
4. Press Forget network.
MDM Installation Procedures (Optional)
NOTE:
Network administrators use MDM (Mobile Device Management)
to manage devices on the network.
1. Press Google Play Store on the Dashboard screen. See
‘Configuring Wi-Fi’ on page 4-23 for more information.
NOTE:
You will be prompted to create a new account or add an
existing one. Choose Add new and follow the instructions.
Google Play Store is now available on the dashboard.
Figure 4-33.
4-24
Google Play Store
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5721203-100 Rev. D
Settings
MDM Installation Procedures (Optional) (continued)
2. Install the correct MDM agent from Google Play (Airwatch,
Mobile Iron).
Figure 4-34.
MDM
3. View the MDM service client with the help of your IT
department.
Figure 4-35.
Vscan Extend – User Manual
5721203-100 Rev. D
MDM installed
4-25
Vscan Extend Settings
MDM Installation Procedures (Optional) (continued)
4. Press the Back arrow to go to Dashboard.
5. Press Kiosk Settings.
NOTE:
Kiosk Settings provides access to advanced settings.
Figure 4-36.
Kiosk Settings
6. Press Admin Console App Chooser.
Figure 4-37.
4-26
Admin Console App Chooser
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5721203-100 Rev. D
Settings
MDM Installation Procedures (Optional) (continued)
7. Select the MDM Agent and press Update.
Figure 4-38. Select MDM Agent
Figure 4-39.
Update
The MDM agent is listed in the Dashboard.
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5721203-100 Rev. D
4-27
Vscan Extend Settings
Certificate Authority
Trusted certificates are typically used to make secure
connections to a server over the Internet.
Use client and Certificate Authority (CA) digital certificates to
enable the device to access VPN or secured Wi-Fi networks,
and also to provide authentication to online secure servers.
You can get a certificate from your system administrator or
download it from sites that require authentication.
1. Press the ... icon at the bottom of the Wi-Fi Screen.
Certificate delivery is completed using an over-the-air
enrollment method, where the certificate is delivered directly
to your Vscan Extend via a browser link.
NOTE:
Contact your system administrator to download certificate
on device.
Figure 4-40.
4-28
Advanced menu
Vscan Extend – User Manual
5721203-100 Rev. D
Settings
Certificate Authority (continued)
2. Press Install certificate.
Figure 4-41.
Install certificate
To complete the install, you need to add the certificate to
your device's security credentials.
•
Press Security on the Settings screen.
•
Select Install from phone storage to get the certificate
file from the downloads folder of your device.
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5721203-100 Rev. D
4-29
Vscan Extend Settings
Certificate Authority (continued)
•
Download the certificate from Downloads.
•
Now that the certificate has been added to your device's
credentials, you can set the certificate name and
choose Wi-Fi depending on the certificate's purpose.
Figure 4-42.
Download Certificate
The certificate is successfully downloaded onto your
Vscan Extend. You can now choose it while connecting
to a certificate based Wi-Fi authentication.
4-30
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5721203-100 Rev. D
Settings
GE Marketplace
Registered users of Vscan Extend (with Wi-Fi Access or DICOM
configuration) have access to GE Marketplace to install
applications like Bladder Volume, Lung Protocol, Case
Exchange and Tricefy on the Vscan Extend.
NOTE:
GE Marketplace registration is separate from device registration
when activating the Vscan Extend.
NOTE:
If the email used during registration is not confirmed, you need
to confirm the email to access GE Marketplace.
Figure 4-43.
Confirm email
A confirmation is sent to the email address to confirm your email
and set your password.
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5721203-100 Rev. D
4-31
Vscan Extend Settings
Installing Vscan Apps
1. Press GE Marketplace on the Settings screen.
Figure 4-44.
Figure 4-45.
4-32
GE Marketplace
Connecting to GE Marketplace
Vscan Extend – User Manual
5721203-100 Rev. D
Settings
Installing Vscan Apps (continued)
2. List of available Vscan apps are displayed.
Figure 4-46.
List of Vscan Apps
3. Select the App (for example, Bladder Volume). Press
Install.
Figure 4-47.
Install app
4. The App gets downloaded and prompts you to install. Press
Install.
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5721203-100 Rev. D
4-33
Vscan Extend Settings
Updating the Marketplace
On the Apps screen list, updates are displayed when available.
Select the App you wish to update and press Update on the App
(for example, Lung Protocol).
NOTE:
If no apps have been installed, a message displays “You have
no apps installed yet.”
NOTE:
While the apps are updating, there is no loss of data. The
updated app requires no new permission.
Uninstalling Apps
1. Press Menu -> Settings -> GE Marketplace. Press the App
to uninstall. For example, Bladder volume.
2. Press Uninstall.
Figure 4-48.
4-34
Uninstall
Vscan Extend – User Manual
5721203-100 Rev. D
Settings
Scenarios while trying to access GE Marketplace
Email address not valid
User will not receive a confirmation email if a valid email
address is not entered to register the Vscan Extend. The
following message displays:
The email address is not confirmed in our system. Request a
confirmation to be resent.
OR
Enter a password matching the email to confirm your device.
Figure 4-49.
Resend confirmation email
Enter a valid email address. A confirmation email is sent. On
your PC, set the password.
Figure 4-50.
Vscan Extend – User Manual
5721203-100 Rev. D
Set password
4-35
Vscan Extend Settings
Email address not confirmed
User has already a registered email address, but the Vscan
Extend is yet to be confirmed. Type the registered email address
and password. Press Login.
Figure 4-51.
Request for confirmation email
A message displays: This Vscan Extend device has been
registered to your account.
The user account details page displays.
Figure 4-52.
Account details
Press the Back arrow and press GE Marketplace.
4-36
Vscan Extend – User Manual
5721203-100 Rev. D
Chapter 5
Using Vscan Extend
Contents:
‘Scanning’ on page 5-2
‘Measurements’ on page 5-24
‘Review and recall of stored data’ on page 5-26
‘Using Vscan Extend Apps’ on page 5-47
Vscan Extend – User Manual
5721203-100 Rev. D
5-1
Using Vscan Extend
Scanning
General scanning recommendations
Before each use:
Inspect the transducer (see ‘Before each use’ on page 6-3).
After Each Use
•
Inspect the transducer (see ‘Cleaning the probe’ on
page 6-6)
•
Clean the transducer (see ‘Disinfecting the probe’ on
page 6-9).
•
If required, clean the device and the display (see
‘Disinfecting the device’ on page 6-7).
•
If required, disinfect the transducer (see ‘Disinfecting the
probe’ on page 6-9).
Ensure that the main unit and the transducer are properly
cleaned after each use and before storing in the case.
WARNING
5-2
If any damage is found on the transducer or its cable, DO NOT
use the Vscan Extend. Contact GE service.
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5721203-100 Rev. D
Scanning
Use of gel
In order to ensure optimal transmission of energy between the
patient and the transducer, a conductive gel must be applied on
the transducer lens.
CAUTION
If the gel comes in contact with the eye, consult the gel
manufacturer's instructions.
The following gels have been tested to be compatible with the
Vscan Extend.
Table 5-1:
Compatible Gels
Aquasonics 100
Parker Laboratory Inc.
Clear Image
Sonotech Inc.
Scan
Parker Laboratory Inc.
Sonogel
Sonogel Vertriebs GmbH
Wavelength
National Therapy Products Inc.
For more information regarding probe care, refer to the website:
http://www3.gehealthcare.com/en/Products/Categories/
Ultrasound/Ultrasound_Probes. Select Dual Probe on Vscan
and G3S Probe on Vscan from the Transducer list to get the
details.
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5-3
Using Vscan Extend
Other recommendations
Like most high frequency computing devices, the electronic
components of Vscan Extend will generate some heat while
operating normally and as intended. Vscan Extend is
equipped with safety mechanisms which will automatically
reduce computing speed (frame rate), and ultimately shut down
the device, before any risk of overheating occurs. Vscan
Extend is verified to comply with harmonized safety standards
(see ‘Conformance Standards’ on page i-3) under any operating
condition described in this user manual (see ‘Environmental
requirements for the device’ on page 3-3). To help keeping the
Vscan Extend operating temperature at an optimal functional
level, and to ensure longer scanning time with maximum frame
rate, it is recommended to hold the Vscan Extend so that
there is good contact between the device and the hand.
CAUTION
5-4
For patient and personnel safety, be aware of biological
hazards. To avoid the risk of disease transmission:
•
Use protective barriers (gloves and transducer sheaths)
whenever possible.
•
Follow all infection control policies established by your
office, department or institution as they apply to personnel
and equipment.
Vscan Extend – User Manual
5721203-100 Rev. D
Scanning
Probe orientation
The sector probe is provided with an orientation mark. This mark
is used to identify the end of the probe corresponding to the side
of the image having the orientation V mark on the scanning
screen.
Figure 5-1.
Sector probe orientation
1. Orientation marking on probe
2. Orientation marking on screen
The dual probe is provided with an orientation mark and a green
LED light. This mark and the LED light are identifying the
orientation of the probe using the fixed symbol displayed on the
screen. In the case of the dual probe, the LED light is also
indicating which probe head is active.
Figure 5-2.
Dual probe: Orientation mark, phased array active
1. Orientation marking on probe
2. Green LED light
3. Orientation marking on screen
Vscan Extend – User Manual
5721203-100 Rev. D
5-5
Using Vscan Extend
Probe orientation (continued)
Figure 5-3.
Dual probe: Orientation mark, linear array active
1. Orientation marking on probe
2. Green LED light
3. Orientation marking on screen
5-6
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5721203-100 Rev. D
Scanning
Patient examination
Creating new exam
A new exam can be created in two ways:
1. The Vscan Extend is powered on and it goes to the
scanning mode.
2. Create New Exam from the Menu screen.
•
Press Menu.
•
Press New Exam.
NOTE:
A new exam gets created when Vscan Extend enters
Standby mode and also when Vscan Extend is
disconnected from a PC.
NOTE:
A new exam will not get saved only with patient details. The
exam will get saved when an image or video is saved for
that exam.
NOTE:
It is recommended to enter patient information using
alphanumeric characters.
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5721203-100 Rev. D
5-7
Using Vscan Extend
Saving a new exam
When an image or video is stored, the exam is automatically
saved.
NOTE:
Current exam ends only when a new exam is created.
Editing patient information for an exam
Patient information can be entered in two ways:
•
Edit Patient on the Menu screen
•
DICOM - Retrieve patient information from DICOM modality
worklist
1. Press Menu -> Edit Patient.
Figure 5-4.
5-8
Edit patient details
Vscan Extend – User Manual
5721203-100 Rev. D
Scanning
Editing patient information for an exam (continued)
2. Enter patient details and press Save.
Figure 5-5.
Save patient details
3. Retrieve patient information from DICOM modality worklist
broker. See ‘DICOM Modality Worklist: Retrieve patient
information from DICOM Modality Worklist broker’ on
page 5-37 for more information.
4. Retrieve the patient information from the DICOM modality
worklist broker. Press Save.
5. Patient information also gets saved when the patient is
associated with an exam with images.
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5721203-100 Rev. D
5-9
Using Vscan Extend
Search Patient
A patient can be searched from either My Worklist or by entering
the patient name or ID.
1. Press Menu -> Edit Patient.
Figure 5-6.
Edit patient
2. Press Search icon.
Figure 5-7.
5-10
Search icon
Vscan Extend – User Manual
5721203-100 Rev. D
Scanning
Search Patient (continued)
3. Type the patient name or patient ID in the search field
NOTE:
Press the Other tab to type the patient name or ID in the
search field.
4. Find patient information on My Worklist (Optional)
If the device is configured for DICOM (depending on the
configuration purchased), patient information can be pulled
from My Worklist. Perform the exam for this patient and
press Save.
Figure 5-8.
NOTE:
Search patient
Patient information can be modified, if needed, using the Edit
Patient feature.
Vscan Extend – User Manual
5721203-100 Rev. D
5-11
Using Vscan Extend
Probe and Presets
The following table indicates the imaging modes supported by
the probes.
Table 5-2:
Probe
Supported imaging modes
Black and white imaging
Color flow
G3S Phased array
X (Harmonic)
Dual probe (G3S phased array
and G8L linear array)
X (Harmonic for G3S phased
array)
To ensure optimal image quality, the Vscan Extend has
predefined scanning settings optimized for different applications
(e.g. Cardiac, Abdominal). Refer to the tables below to select
the correct probe and preset combination before scanning.
Table 5-3:
Phased array transducer in G3S and Dual Probe (deep scanning) presets
Phased array
transducer in G3S
and Dual Probe
(deep scanning)
5-12
Preset
Optimized for
Cardiac
• Heart
• Aorta
• Lung
Abdominal
• Liver
• Kidney
• Gall bladder
• Spleen
• Urology
• Selective peripheral vascular
Obstetrics
OB/Gyn
Adult Cephalic
Various cephalic structures
Aorta
Abdominal Aorta
Vscan Extend – User Manual
5721203-100 Rev. D
Scanning
Probe and Presets (continued)
Table 5-4:
Linear transducer in Dual Probe (shallow scanning) presets
Linear transducer
in Dual Probe
(shallow scanning)
Preset
Optimized for
Vascular
• Veins
• Arteries
Soft tissue
• Small organs
• Pediatric (recommended minimum weight:
4 kg)
• Musculoskeletal - including Long bone, Hip,
Knee, Shoulder and Elbow
Lung
• Thoracic/Pleural motion
• Fluid detection
Adult Cephalic
Various cephalic structures
Ophthalmic*
Ophthalmic
* Ophthalmic is available as an option for certain countries but is NOT available in the USA, China and
Japan.
NOTE:
Vscan Extend with Dual probe (shallow and deep) can be used
for procedural guidance.
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5721203-100 Rev. D
5-13
Using Vscan Extend
To change the preset and probe
1. Press Menu.
2. Press the ... on the Preset tab.
Figure 5-9.
Menu page
3. The presets for the available probe(s) are displayed. The
preset automatically selected activates the probe for that
preset.
Select the desired probe/preset.
Figure 5-10.
5-14
Change Preset
Vscan Extend – User Manual
5721203-100 Rev. D
Scanning
Creating preset favorites
Up to three presets can be saved as favorites and are available
for quick access on the Menu page.
To save favorites:
1. Press Menu.
2. Press the ... on the Preset tab.
Figure 5-11.
Menu page
3. Press and hold the preset icon to select the desired favorite.
The icon changes to blue to indicate the saved favorite.
Figure 5-12.
Presets favorites
1. Probe/Preset Availability
2. Preset Favorites (blue icon)
Vscan Extend – User Manual
5721203-100 Rev. D
5-15
Using Vscan Extend
Creating preset favorites (continued)
The Menu page displays the selected favorites.
Figure 5-13.
NOTE:
Menu page
Only three presets can be selected as favorites at one time.
Deselect a current favorite in order to add another preset as a
favorite.
To deselect a favorite, press and hold the preset icon. The color
of the icon changes to gray (Figure 5-11).
5-16
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5721203-100 Rev. D
Scanning
Black and white imaging
Black and white imaging is intended to provide two-dimensional
images and measurement capabilities concerning the
anatomical structure of soft tissue.
Black and white imaging is the default scanning mode.
Figure 5-14.
NOTE:
Black and white scan screen
As a safety precaution, scanning is not possible when charging
the battery.
Vscan Extend – User Manual
5721203-100 Rev. D
5-17
Using Vscan Extend
Black and white imaging (continued)
Black and white imaging adjustments
The following adjustments can be done to further improve the
image quality:
1. Gain - Black and white gain increases or decreases the
amount of echo information displayed in an image. It may
have the effect of brightening or darkening the image if
sufficient echo information is generated.
•
Press the Gain icon.
The gain slider disappears after a few seconds. Press
Gain again to activate the slider.
•
Use the gain slider to increase or decrease gain.
•
Press the Gain icon again to hide the control.
Figure 5-15.
5-18
Gain
Vscan Extend – User Manual
5721203-100 Rev. D
Scanning
Black and white imaging adjustments (continued)
•
Depth adjusts the field of view. It increases the field of
view to look at larger or deeper structures; it decreases
the field of view to look at structures near the skin line.
•
Press the Depth icon.
•
Use the depth slider to increase or decrease depth.
The depth slider disappears after a few seconds. Press
the Depth icon again to activate the control.
•
Press the Depth icon again to hide the depth control, if
needed.
Figure 5-16.
Vscan Extend – User Manual
5721203-100 Rev. D
Depth
5-19
Using Vscan Extend
Color imaging
Color imaging is intended to add color coded qualitative
information concerning the relative velocity and direction of fluid
motion within the black and white image.
1. Press the Color icon.
Figure 5-17.
Color scan
A color flow area displays on top of the black and white
image.
2. Press and hold the color region of interest. The region of
interest changes to yellow, indicating it is ready to be moved
within the scan area. Drag the region of interest to the
desired area of interest.
5-20
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5721203-100 Rev. D
Scanning
Color imaging (continued)
3. Press Gain to access the color gain control.
Figure 5-18.
Color gain
Color gain amplifies the overall strength of echoes
processed in the color area.
Vscan Extend – User Manual
5721203-100 Rev. D
5-21
Using Vscan Extend
Color imaging Scanning Adjustments
Color Aliasing
If the blood flow velocity exceeds the maximum velocity range
the system can cover, based on the sampling rate used, aliasing
occurs.
Aliasing appears as a shift in color from the color representing
positive velocity to color representing negative velocity or visa
versa.
The maximum velocity is displayed on top of the color bar.
Color steer
Slant the ROI (Region of Interest) of the Color Flow linear image
left or right to get more information without moving the probe.
Press and hold the color region of interest. The region of interest
changes to yellow, indicating it is ready to be steered in a
different direction. Drag the region of interest to the left or right
depending on the desired angle.
NOTE:
Angle Steer applies only to the linear functionality of the Dual
Probe.
Figure 5-19. Color steer
5-22
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5721203-100 Rev. D
Scanning
Auto freeze
If Vscan Extend is idle for a period of time, the device enters
freeze mode to minimize risk of overheating and battery
drainage. Press the display to unfreeze the image and continue
scanning. See ‘Scan Settings’ on page 4-2 for more information.
AutoCycle
Vscan Extend does not include an ECG interface as often found
on larger ultrasound systems intended for cardiovascular
applications. The AutoCycle feature detects a complete cardiac
cycle by analyzing the cyclicity of the ultrasound intensity data.
The resulting time-stamps are used for storing and playing
cineloops smoothly. The AutoCycle feature should typically
detect heart rates in the range 46–100 beats per minute. If the
detected heart cycle is outside this range, or if the cyclicity
quality is too poor, a default 2 sec loop will be used instead. The
detected start and stop times for the AutoCycle are not
necessarily in phase with the QRS complex. Since adequate
cyclicity can only be expected in cardiac applications, all other
applications will use the default config settings.
Use of sterile sheath
It is recommended to use a sterile sheath around the probe and
main unit if Vscan Extend is used as an aid to needle guidance
or in any clinical situation where contamination could be a
concern.
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5721203-100 Rev. D
5-23
Using Vscan Extend
Measurements
Taking measurements
Vscan Extend enables distance measurement on frozen images
in both black and white and color imaging. Up to eight
measurements can be performed on an image. Measurements
can be done during image review or on recalled stored images.
To perform a measurement:
1. On a frozen image, press Measure.
The measurement calipers displays.
2. Drag to position the calipers to obtain the desired
measurement.
3. To store the image with a measurement, press Store.
Figure 5-20.
5-24
Measurement
Vscan Extend – User Manual
5721203-100 Rev. D
Measurements
Taking measurements (continued)
4. Press Add New to make additional measurements on the
displayed image. Up to 8 measurements can be made on a
single image.
Figure 5-21.
5.
Add new measurement
Press Delete to delete a single measurement.
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5721203-100 Rev. D
5-25
Using Vscan Extend
Review and recall of stored data
Backups Recommended
During live scanning, acquired images or videos are stored in
the internal memory (image buffer). When the internal memory
reaches 45% to 50% of its capacity, it is recommended to
perform backup. To prevent loss of any images and videos,
previously acquired images and videos must be stored to the
microSD card. See ‘Backup’ on page 5-42 for more information.
NOTE:
The number of images and videos that can be stored depends
on the internal memory of the device.
NOTE:
Backup data at regular intervals. If backup is not performed, the
internal memory data can be lost and cannot be retrieved.
Reviewing and recalling images or videos from an exam list
1. Press Menu.
2. Press Exams.
A list of exams, with stored images and videos, display.
3. Press on the desired patient and then press the image or
video to get the full screen view.
5-26
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5721203-100 Rev. D
Review and recall of stored data
Reviewing and recalling images or videos from an exam list
(continued)
Figure 5-22.
NOTE:
View stored images and videos
Press on the image in the Exams screen. Use the right/left arrow
to naviagte through the images/videos.
Vscan Extend – User Manual
5721203-100 Rev. D
5-27
Using Vscan Extend
Deletion of data
To delete a file
You can delete images or videos individually or from an exam
list.
Deleting individual images or videos
1. Press Menu.
2. Press Exams.
3. Select the Exam from which images or videos are to be
deleted.
4. Press Delete.
5. Select the images or videos to be deleted.
Figure 5-23.
Images to be deleted
6. Press Delete to delete the images.
OR
7. Press Cancel to cancel deletion.
Figure 5-24.
5-28
Delete or cancel
Vscan Extend – User Manual
5721203-100 Rev. D
Review and recall of stored data
Delete images from an exam list
1. Press Menu.
2. Press Exams.
3. Select the exam from the list.
Figure 5-25.
Images to be deleted
4. Press Delete to delete the images.
OR
5. Press Cancel to cancel deletion.
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5-29
Using Vscan Extend
Data Export
Data can be exported to a PC (‘USB Export’ on page 5-31),
shared to a PC, exported to a DICOM server (‘DICOM Store:
exporting DICOM images from Vscan Extend to DICOM image
server’ on page 5-39), through Windows Share (‘Windows
Share’ on page 5-32) or to GE’s separate cloud-based case
exchange solution, if available on the device purchased.
NOTE:
GE’s separate cloud-based case exchange solution is available
in the U.S. and UK only.
Audit Logs
The Vscan Extend has audit logs of various types of events and
activities.
The audit logs captured in the microSD card can be exported to
a PC. A report can be generated using these audit logs.
The audit logs capture the following information:
1. Device Start/Shut-down time
2. Incorrect password attempts
3. Additions and modifications to system configuration,
including:
•
DICOM connection
•
Windows Share connection
•
Wi-Fi connection and security details (SSID, Network
disconnect/connect timings)
•
Application software install/uninstall/upgrade
•
Registration of partnering apps
4. Events related to Patient Data, including the following
details:
•
Date/Time of data access
•
Type of action (addition, deletion, modification,
reviewed)
NOTE:
Audit logs do not show the transfer of data to the PC.
•
Applications used (Bladder Volume, Lung Protocol, etc.)
5. Data Export
•
Date/Time of data export, including end point and Wi-Fi
SSID information
•
Data Backup/Restore details
6. Invalid Device PIN attempt
7. Kiosk admin mode login success and failure
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Review and recall of stored data
USB Export
Patient images and videos can be transferred from Vscan
Extend to a Personal Computer (PC) using a USB cable.
The images or videos have the following details:
•
Color ROI
•
Depth marker
•
Probe indicator
•
Exam ID
Export files
JPG and MPEG files, stored on the device internal memory, can
be exported to a PC with a USB cable. The folder and file names
start with the device ID (serial number), then exam ID and
NNNNN. The folder structure looks like:
....\Archive\EEEEEEE-XXXXXXX\EEEEEE-NNNNN-XXXXXXX.
mpg
....\Archive\EEEEEEE-XXXXXXX\EEEEEE-NNNNN-XXXXXXX.
jpg
where
EEEEEEE is the device ID.
XXXXXX is the exam ID.
NNNNN is the file number in the folder.
The files, file names, and folder names are non-patient
identifiable.
Import data
The files exported to the PC can be copied back to a specific
folder to the device with the USB cable (...\Import)
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5-31
Using Vscan Extend
Windows Share
Windows share allows the system to send ultrasound images to
a PC.
1. Press Windows share from the list. Enter the required
details - Domain name, IP address, User name and
Password.
Figure 5-26. Windows share
2. Press Add server.
NOTE:
All the required fields need to be entered.
3. Press Verify.
A Verify OK message displays.
4. Create a shared folder on the PC and provide the
credentials and domain name.
5. Provide access to users who need access to the shared
folder.
5-32
NOTE:
Windows Share can also be added as a favorite and can be
deleted as a favorite.
NOTE:
Share option is enabled only when any one of the fields in
the patient details page is entered. Only images and videos
are exported to the PC with the patient information
anonymized.
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Review and recall of stored data
Share images
1. Press Menu on the scan screen.
2. Press Exams to be exported.
3. Press Upload Selected.
4. Select the created Windows Share destination.
The exported folder is as as shown in the Figure 5-27 below.
Figure 5-27.
Figure 5-28.
Vscan Extend – User Manual
5721203-100 Rev. D
Exported image folder
Images inside the exam folder
5-33
Using Vscan Extend
Share images (continued)
5. If the exported image does not get transferred to the PC or if
the transfer fails, a red icon appears next to the image.
Figure 5-29.
5-34
Transfer failed
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5721203-100 Rev. D
Review and recall of stored data
Device Status
To monitor/control DICOM and Windows share jobs, press
Settings -> Device Status.
The exam screen displays the job status, which range from:
•
in progress
•
success
•
failed
•
not started
Figure 5-30.
Vscan Extend – User Manual
5721203-100 Rev. D
Device Status
5-35
Using Vscan Extend
DICOM
NOTE:
This feature is available with the DICOM configuration.
Overview
Vscan Extend supports the following DICOM functionality:
•
Verify. See ‘Configure Worklist Server’ on page 4-5 for more
information.
•
Modality Worklist
•
Store
DICOM users can use:
1. DICOM Modality Worklist: Retrieve patient information from
DICOM modality worklist broker
2. Add patient identifying information to exam.
•
manually
•
selecting from modality worklist
3. DICOM Store: Export DICOM images from Vscan Extend to
the DICOM image server.
DICOM modality worklist server
To configure the DICOM modality worklist server, See ‘Configure
Worklist Server’ on page 4-5 for more information.
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Review and recall of stored data
DICOM Modality Worklist: Retrieve patient information from DICOM Modality
Worklist broker
Vscan Extend can download and refresh a DICOM modality
worklist. An exam can be linked to an existing patient pulled
from the worklist, prior to exporting to the DICOM image server.
NOTE:
It is not necessary to refresh the modality worklist for each
exam.
NOTE:
When data is accessed for the first time, the device prompts for
a ‘PIN’; enter the pin for security purposes.
1. Press Menu - > Worklist.
Figure 5-31.
Vscan Extend – User Manual
5721203-100 Rev. D
Worklist
5-37
Using Vscan Extend
DICOM Modality Worklist: Retrieve patient information from DICOM Modality
Worklist broker (continued)
2. Press Refresh to download Worklist entries.
Figure 5-32.
NOTE:
5-38
Refresh Worklist
It is not be possible to change the following DICOM
attributes received from worklist: Patient Name, Patient ID
and Accession Number.
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5721203-100 Rev. D
Review and recall of stored data
DICOM Store: exporting DICOM images from Vscan
server
Extend to DICOM image
At the end of an exam, ensure the Patient ID is linked to the
exam. This is required before exporting images or videos. See
‘Patient examination’ on page 5-7 for more information.
1. Press Menu -> Exams
Figure 5-33.
Exams
2. Press the Export icon.
Figure 5-34.
Export
NOTE:
Individual images from an exam or an entire exam can be
selected for export.
NOTE:
At least one of the required fields in patient details need to
be filled in before export is enabled.
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5721203-100 Rev. D
5-39
Using Vscan Extend
DICOM Store: exporting DICOM images from Vscan Extend to DICOM image server
(continued)
3. If more than one storage destination is configured, select
the desired destination.
Figure 5-35.
Choose destination
4. Press Upload Selected to export the exam.
Figure 5-36.
Upload selected exam
The selected exam(s) are exported to the DICOM server.
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5721203-100 Rev. D
Review and recall of stored data
DICOM Store: exporting DICOM images from Vscan Extend to DICOM image server
(continued)
5. A green icon indicates a successful export.
A gray icon indicates the export was initiated and is pending
upload.
If an exported image does not successfully transfer to the
DICOM server, a red icon appears next to the image.
If the user did not attempt to export an image, no icon
displays next to the image.
NOTE:
To refresh the screen to see the current status, exit the page
and return to the same page.
Figure 5-37.
Transfer failed
All still images can be sent to the DICOM image server. Videos
may be sent to the DICOM image server only if “Enable
MultiFrame DICOM” is selected in the DICOM server
configuration.
Up to 100 images can be exported at one time.
The multiframe video is limited to 4 seconds.
NOTE:
If the export is unsuccessful, it takes about 20 minutes until a
failure message appears as the device attempts to resend the
images/videos.
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5-41
Using Vscan Extend
Backup
It is highly recommended to backup patient data on a microSD
card, at regular intervals, to avoid data loss.
The microSD card inside the device captures the error log files.
WARNING
It is important to retain these error logs. It is also recommended
to perform a backup of these logs for specified dates. GE is not
responsible for loss data of these logs.
Backup MUST be performed before sending the system to the
repair depot as the data is wiped from the internal memory and
cannot be retrieved.
NOTE:
The microSD card backup requires a length of time to process,
the time being dependent on the number of images/videos
requiring backup. For example, 1000+ videos in 50 to 60 exams
takes approximately 14 minutes to back up to the microSD card.
To backup patient data:
1. Power OFF the Vscan Extend.
2. Remove the Battery. See ‘Inserting/removing the battery’ on
page 3-20 for more information. Remove the microSD card
containing the log files from the device and insert a blank
microSD card.
3. Remove the microSD card containing the log files from the
device and insert a blank microSD card. See Figure 6-3 on
page 6-12 to insert the SD card.
4. Press Menu -> Settings -> Backup.
Figure 5-38.
5-42
Backup
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5721203-100 Rev. D
Review and recall of stored data
Backup (continued)
5. A pop-up displays.
Figure 5-39.
Backup data message
Press Allow to initiate backup OR Cancel to stop the
backup process.
6. If the backup process is successful, the patient, exam, logs,
and configuration data are backed up on the microSD card.
The following message displays.
Figure 5-40.
Vscan Extend – User Manual
5721203-100 Rev. D
Backup successful
5-43
Using Vscan Extend
Backup (continued)
If the backup process is unsuccessful, a failed message
displays.
Figure 5-41.
NOTE:
Backup failed
If the available memory on the microSD card is less than
50% when initiating backup, the process fails.
Retry backup. If still unsuccessful, insert a new microSD
card and try again.
7. After backup is complete, power OFF the Vscan Extend.
Remove the battery. Remove the backup microSD card and
store in a safe place.
8. Insert the original microSD card, containing the error logs,
into the device. Power ON the Vscan Extend.
5-44
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Review and recall of stored data
Restore
CAUTION
The restore procedure overwrites the existing data on the
Vscan Extend.
When restoring previously-backed up patient data, you must
first backup the current patient data as the restore procedure
overwrites the existing data. See ‘Backup’ on page 5-42 for
more information.
Make sure to insert the correct microSD card.
NOTE:
The restore operation does not restore backed up logs.
1. Power OFF the Vscan Extend.
2. Remove the Battery. See ‘Inserting/removing the battery’ on
page 3-20 for more information. Remove the microSD card
containing the log files from the device and insert a blank
microSD card.
3. Remove the microSD card containing the log files from the
device and insert the microSD card with the backed up data.
See Figure 6-3 on page 6-12 to insert the SD card.
4. Press Menu -> Settings -> Restore.
Figure 5-42.
Vscan Extend – User Manual
5721203-100 Rev. D
Restore
5-45
Using Vscan Extend
Restore (continued)
5. A pop-up displays.
Figure 5-43.
Restore Confirmation
Press Allow to initiate restore OR Cancel to stop the
restore process.
6. If the restore procedure is successful, the patient, exam,
and configuration data are restored to the device.
If the restore procedure fails, a pop-up displays.
Figure 5-44.
Restore failed
If the microSD card does not contain any patient details to
restore, a pop-up displays. The system automatically shuts
down.
Figure 5-45. Power off
7. After restore is complete, power OFF the Vscan Extend.
Remove the battery. Remove the backup microSD card and
store in a safe place. The data is still retained on the
microSD card.
8. Insert the original microSD card, containing the error logs,
into the device. Power on the Vscan Extend.
5-46
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Using Vscan Extend Apps
Using Vscan Extend Apps
Overview
There are four Apps avaiable on the Vscan Extend:
•
Bladder Volume
•
Lung Protocol
•
Tricefy Uplink
Bladder Volume
The Bladder Volume App calculates the bladder volume using 3
distance measurements from two orthogonal images
(transverse and sagittal).
Two distances are taken from the transverse image and one
distance from the sagittal image, at the widest points, to
calculate the bladder volume.
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5721203-100 Rev. D
5-47
Using Vscan Extend
Installing the Bladder Volume application
1. Press Menu -> Settings -> GE Marketplace.
Figure 5-46.
GE Marketplace
A list of available apps displays.
2. Press Bladder Volume App to view details.
3. Press Install. See ‘Installing Vscan Apps’ on page 4-32 for
more information.
The Bladder app installs.
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Using Vscan Extend Apps
Bladder Volume settings
1. Press App Settings from the Settings menu. A pop-up
displays.
Figure 5-47.
Bladder Volume app settings
2. Press on the desired formula.
Figure 5-48.
•
[0.7 x (D1 x D2 x D3)]
•
[0.52 x (D1 x D2 x D3)]
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5721203-100 Rev. D
Bladder volume formula
5-49
Using Vscan Extend
Using Bladder Volume
To use the bladder app, the following are prerequisites:
•
Install the app using GE Marketplace.
•
Phased array probe is active.
•
Live image is frozen.
The Bladder Volume App runs an algorithm on the currently
displayed image frame, finding the widest points on the bladder
contour and placing the measurement calipers at these widest
points.
1. On the scanned transverse image, press to Freeze.
The Bladder Volume App icon displays at the bottom of the
screen.
Figure 5-49. Bladder App icon
2. Scroll to select a suitable frame.
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5721203-100 Rev. D
Using Vscan Extend Apps
Using Bladder Volume (continued)
3. Press the Bladder icon to start the bladder measurement.
The measurement cursors appear to perform the
measurement.
The widest points (D1 and D2) in a transverse image are
perpendicular to each other.
Figure 5-50.
Transverse
1. D1 - Longitudinal maximum length
2. D2 - AP diameter
NOTE:
The Transverse Measure screen is displayed by default.
Vscan Extend – User Manual
5721203-100 Rev. D
5-51
Using Vscan Extend
Using Bladder Volume (continued)
4. Adjust the measurement calipers manually, if required.
5. Press Store. The screen enters sagittal capture.
6. Press to Freeze. Scroll to select the best frame.
7. Press Measure Frame.
Figure 5-51.
Measure Frame
The image, along with the measurement values and
volume, displays.
Figure 5-52.
Measurement values
8. Press Store.
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Using Vscan Extend Apps
Using Bladder Volume (continued)
NOTE:
The image is saved with the measurement values and volume
embedded on it.
View the saved images from the gallery.
NOTE:
The Bladder app cannot be used on stored images in the gallery.
NOTE:
If a sagittal image is acquired first and the step needs to be
changed to sagittal, press the Sagittal toggle button.
Figure 5-53.
Toggle button
Exiting Bladder Volume
1. Press Close to exit the Bladder Volume App.
Figure 5-54. Exit Bladder Volume App
1. Close
2. Quit
A pop-up displays for confirmation.
2. Press Quit to exit the Bladder Volume app.
3. Press Cancel to continue using the Bladder Volume app.
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5721203-100 Rev. D
5-53
Using Vscan Extend
Lung Protocol
Lung Protocol application guides you through a step by step
lung ultrasound exam.
The application performs the following functions:
1. Automatic lung preset selection
2. Guides or helps assessing the stored images
3. Helps to calculate a total lung score
4. Generates a simple report at the end of the exam
Installing the Lung Protocol application
1. Press Menu -> Settings -> GE Marketplace.
A list of available apps displays.
2. Press Lung Protocol to view details.
3. Press Install.
The Lung Protocol app installs.
Lung Protocol settings
1. Press Start a protocol on the Menu screen.
2. Press the Lung Protocols Settings icon on the Protocols
screen to choose the desired settings.
Figure 5-55.
5-54
Start a protocol
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5721203-100 Rev. D
Using Vscan Extend Apps
Lung Protocol settings (continued)
The Settings screen displays.
Figure 5-56.
Settings
The Settings menu has the following functions:
•
choose the number of segments to be scanned
•
choose the type of assessment
•
enter the Help mode.
Number of segments
Three different configurations are available for the number of
segments. Press on the radio button to choose any one of the
following:
•
4x2
•
7x2
•
6x2
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5-55
Using Vscan Extend
Lung Protocol settings (continued)
Types of Assessment
Two types of assessment are available. Press on the radio
button to choose the desired type of assessment.
•
Quantitative
•
Qualitative.
Help mode
Help mode is required to guide the user through the Lung
Protocol.
Swipe from left to right to turn ON the Help mode on the Lung
Protocol Settings menu. See Figure 5-56 on page 5-55.
Help mode assists in the following:
•
Skip - when you enter the next segment, swipe from right to
left to skip the current segment.
•
Next - swipe from right to left to enter the next segment.
•
When multiple images are scored in the same segment, a
pop-up appears:
“Only latest saved image will be available for review”.
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Using Vscan Extend Apps
Lung Protocol settings (continued)
3. Press the Back arrow to return to the Protocols screen.
Figure 5-57.
Back arrow
4. Press Lung Protocol to start using the lung protocol.
NOTE:
The settings are automatically saved. If the settings need to be
changed, stop the current protocol on the menu screen and
modify the current settings on the Settings menu.
Using Lung Protocol
1. Press Menu.
2. Press Start a protocol.
3. Press Lung Protocol.
Figure 5-58.
Vscan Extend – User Manual
5721203-100 Rev. D
Lung protocol
5-57
Using Vscan Extend
Using Lung Protocol (continued)
4. The lung linear preset is automatically applied. The lung
preset is added as favorite in the Preset menu.
Figure 5-59.
Preset menu
The scan screen displays.
Figure 5-60.
Lung protocol scan screen
1. Displays current segment name
2. Displays previous, current and next segments
5. Press Store to save the images or Cine loops for the current
segment. The saved image icon appears at the upper left
corner of the scan screen.
6. Swipe from right to left to move to the next segment, for
example 1R to 2R, where 1R is the first segment of the right
lung. Similarly, 1L is the first segment of the left lung.
OR
Swipe from left to right to move to the previous segment.
The number of segments that can be scored depends on the
number of segments selected on the Settings menu.
5-58
NOTE:
The user is able to store multiple images per segment. Only the
latest saved image, for a particular segment, is available for
review. However, the user can view all the images in the Gallery
under the current exam.
NOTE:
The appearance of the 'Gallery' icon indicates if an image and/or
video is stored in the segment.
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5721203-100 Rev. D
Using Vscan Extend Apps
Review and score images
After all the images are stored for all the segments, a pop-up
displays:
Figure 5-61.
Score images
Press Score to score the images. Choose the score for each
segment.
OR
Press Go Back to acquire more images.
Depending on the type of assessment chosen on the Lung
Protocol Settings menu, either Quantitative or Qualitative
assessment scores are displayed. Both the screens are shown
below.
Figure 5-62.
1. Quantitative
NOTE:
Quantitative and Qualitative Scores
2. Qualitative
It is not mandatory to score all images.
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5721203-100 Rev. D
5-59
Using Vscan Extend
Lung Protocol report
After reviewing and scoring the last segment, swipe from right to
left to enter the report screen.
The report shows the current patient name, patient ID, and total
lung score.
Figure 5-63.
Figure 5-64.
Quantitative report
Qualitative report
Press Save to save the report. The report is stored with all the
images and videos from the gallery.
Press Exams on the Menu screen to view the images and the
report.
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Using Vscan Extend Apps
Exit Lung Protocol
1. Press Menu on the Lung protocol screen.
2. Press Stop current protocol. A pop-up displays.
Figure 5-65.
Stop current protocol
3. Press Exit to stop the protocol.
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5-61
Using Vscan Extend
Tricefy
Tricefy Uplink helps to upload exams to the cloud.
1. Press Menu -> Settings -> GE Marketplace
2. Press Install.
The Tricefy Uplink app installs.
Using Tricefy
1. Press Menu -> Settings -> Server Settings
2. Press Tricey under Image Server
Figure 5-66.
5-62
Tricefy
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5721203-100 Rev. D
Using Vscan Extend Apps
Using Tricefy (continued)
3. Enter your email address to register for Tricefy and press
Activate. OR if you have a Tricefy login, enter that address
and press Login.
Figure 5-67.
Tricefy Activate or login
4. Press Add Server and Verify.
Figure 5-68.
Vscan Extend – User Manual
5721203-100 Rev. D
Add Ticefy and Verify
5-63
Using Vscan Extend
Using Tricefy (continued)
5. Press Menu -> Export icon.
Figure 5-69.
Export
6. Press Upload Selected to export the exam.
Figure 5-70.
Upload selected exam
The selected exam(s) are exported to the Tricefy server.
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Chapter 6
Vscan Extend Maintenance
Contents
‘System care and maintenance’ on page 6-2
‘Inspection’ on page 6-3
‘Upgrade software’ on page 6-12
‘Troubleshooting’ on page 6-14
Vscan Extend – User Manual
5721203-100 Rev. D
6-1
Vscan Extend Maintenance
System care and maintenance
Overview
CAUTION
The user must ensure that safety inspections are performed at
least every 12 months according to the requirements of the
patient safety standard EN/ES/IEC 60601-1 and its national
deviations or according to the requirements of the IEC62353
standard, medical electrical equipment – recurrent test and test
after repair of medical electrical equipment.
Only trained persons should perform the safety inspections.
The Vscan Extend requires regular care and maintenance to
function safely and properly.
The expected service life of the Vscan Extend is 5 years.
To ensure that the Vscan Extend constantly operates at
maximum efficiency, we recommend that the following
procedures be observed as part of the customer’s internal
routine maintenance program.
6-2
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System care and maintenance
Inspection
Inspecting the Vscan Extend
CAUTION
If any defects or damages are found on the control unit, the
probe or its cable, DO NOT use the Vscan Extend. Contact GE
service.
Examine the following on a monthly basis (or whenever there is
a reason to assume that any issue may have occurred):
•
WARNING
Connectors on cables, for any mechanical defects
•
Entire length of electrical cables, for cuts or abrasions
•
Equipment for cracks, loose or missing hardware.
To avoid electrical shock hazard, do not remove covers from
the Vscan Extend.
Before each use
1. Inspect the lens, the probe housing and the cable.
2. Look for damage that might allow liquid into the probe.
3. Test the functionality of the probe.
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5721203-100 Rev. D
6-3
Vscan Extend Maintenance
Cleaning and disinfection
Cleaning the device
Make sure the device is disconnected from the AC/DC adapter
before cleaning.
1. Power off the Vscan Extend.
2. Moisten a soft, non-abrasive cloth with a mild, general
purpose, non-abrasive soap and water solution.
3. Wipe the Vscan Extend.
4. Wipe dry with a soft towel.
CAUTION
Do not spray the soap and water solution directly onto the
Vscan Extend.
Reprocessing recommendation (Frequency)
After Each Use
•
Inspect the transducer (see ‘Inspecting the Vscan Extend’
on page 6-3)
•
Clean the transducer (see ‘Disinfecting the probe’ on
page 6-9).
•
If required, clean the device and the display (see
‘Disinfecting the device’ on page 6-7).
•
If required, disinfect the transducer (see ‘Disinfecting the
probe’ on page 6-9).
Ensure that the main unit and the transducer are properly
cleaned after each use and before storage in the case.
WARNING
6-4
If any defects or damages are found on the probe or its cable,
DO NOT use the Vscan Extend. Contact GE service.
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5721203-100 Rev. D
Cleaning and disinfection
Special Label Designations, Warnings and Precautions
Never use thinner, benzene, abrasive cleaners, or other strong
solvents, as these may cause damage to the Vscan Extend.
Do not soak or saturate probes with solutions containing bleach,
ammonium chloride compounds or hydrogen peroxide.
Special accessories
Special accessories are not applicable.
Point-of-Use Processing
No point-of-use processing is required prior to cleaning.
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5721203-100 Rev. D
6-5
Vscan Extend Maintenance
Cleaning instructions
CAUTION
Avoid any liquid making contact with the internal device
components, including the micro USB connector and battery
terminal contacts, which are not designed for making contact
with liquids.
Cleaning the probe
1. Remove the gel by wiping the probe lens with a soft cloth.
2. Wipe the probe and cable with a soft cloth moistened with a
warm soap and water solution (<80 0F/27 0C).
3. Wipe the probe and cable with a soft cloth moistened with
clean water (<80 0F/27 0C) until all soap is removed.
4. Wipe dry with a soft towel.
Cleaning the USB door
1. Open the USB door.
2. Wipe the inside of the door with a soft cloth moistened with a
mild, general purpose, non-abrasive soap and water
solution.
3. Wipe dry with a soft cloth.
Figure 6-1.
Open the USB door
Method of cleaning: Manual
CAUTION
DO NOT use brush, abrasives, sharp tools or any other
methods that may damage the inside or surface of the device.
DO NOT scratch or press any part of the Vscan Extend with a
sharp object, such as pencils or pens, as this may result in
damage to Vscan Extend.
6-6
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Cleaning and disinfection
Disinfecting the device
After cleaning, the device may be wiped with a tissue sprayed
with a recommended germicide.
Recommended germicides
In order to provide users with options in choosing a germicide,
GE routinely reviews new medical germicides for compatibility
with the Vscan Extend and its probe. Although a necessary step
in protecting patients and employees from disease transmission,
liquid chemical germicides must also be selected to minimize
potential damage to the probe.
Table 6-1:
NOTE:
WARNING
Germicides
PI-Spray
Pharmaceutical Innovations
PI-Spray II
Pharmaceutical Innovations
CaviWipes
Metrex
Cleanisept wipes
Dr. Schumacher GmbH
Septiwipes
Dr. Schumacher GmbH
Sani-Cloth HB
PDI
Refer to the cleaning agent labeling for preparation and use
instructions.
Use only compatible germicides. In addition, refer to the local /
national regulations.
NOTE:
Follow the manufacturer's instructions for storage, use and
disposal of the disinfection solution.
NOTE:
No special accessories are required for disinfection.
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5721203-100 Rev. D
6-7
Vscan Extend Maintenance
Cleaning agents
Follow the instructions described below while using CaviWipes
and Sani-Cloth HB.
CaviWipes
1. Use one CaviWipes towelette to completely preclean the
surface of the device, probe and cable.
2. Ensure that no debris and bioburden are left behind.
3. Discard used towelette.
4. Use a second CaviWipes towelette to thoroughly wet the
surface in order to disinfect the precleaned surface.
Repeated use of the product may be required to ensure that
the surface remains visibly wet for 3 minutes at room
temperature (20 degrees).
Sani-Cloth HB
1. Use one Sani-Cloth HB towelette to completely preclean the
surface of the device, probe and cable
2. Ensure that no debris and bioburden are left behind.
3. Discard used towelette.
4. Use a second Sani-Cloth HB towelette to thoroughly wet the
surface in order to disinfect the precleaned surface.
Repeated use of the product may be required to ensure that
the surface remains visibly wet for 10 minutes at room
temperature (20 degrees).
6-8
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5721203-100 Rev. D
Cleaning and disinfection
Disinfecting the probe
After cleaning, the probe and cable may be wiped with a tissue
sprayed with a recommended germicide.
In order to provide users with options in choosing a germicide,
GE routinely reviews new medical germicides for compatibility
with the materials used in the transducer housing, cable and
lens. Although a necessary step in protecting patients and
employees from disease transmission, liquid chemical
germicides must also be selected to minimize potential damage
to the probe.
Refer to the internet link below for the latest list of compatible
cleaning solutions and disinfectants:
http://www3.gehealthcare.com/en/Products/Categories/
Ultrasound/Ultrasound_Probes
WARNING
Never use any cleaning solutions and disinfectants other than
the ones mentioned in the Ultrasound Probes web page.
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5721203-100 Rev. D
6-9
Vscan Extend Maintenance
Disinfecting the probe (continued)
WARNING
Do not immerse the probe in any liquid beyond the level
specified (see Figure 6-3).
The probe should not be exposed to the germicide longer than
specified in order to achieve the desired effect.
Rinse the part of the probe which is in contact with the
germicide according to the germicide manufacturer’s
instructions.
Wipe dry with a soft towel.
Figure 6-2.
1. Maximum saline level
2. Minimum saline level
WARNING
Probe immersion level
a. Linear array transducer
b. Phased array transducer
c. G3S probe
Use additional precautions (e.g. gloves and gown) when
decontaminating an infected probe.
The probe should not be exposed to the germicide longer than
specified in order to achieve the desired effect.
6-10
Vscan Extend – User Manual
5721203-100 Rev. D
Cleaning and disinfection
Disinfecting the probe (continued)
WARNING
CREUTZFELDT-JAKOB DISEASE
This device is not indicated for neurological use. Neurological
contact on patients with this disease MUST BE avoided. If a
device/probe becomes contaminated, there is no adequate
means to disinfect it. In this case, the contaminated device/
probe MUST BE discarded in accordance with local biologic
waste hazard procedures.
Biological
Hazard
Rinsing and Lubricating Agents
No rinsing and lubricating agents are required.
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5721203-100 Rev. D
6-11
Vscan Extend Maintenance
Upgrade software
Scanner software
You can upgrade the currently installed software to a software
version equal to or greater than your current version.
NOTE:
Before proceeding with the upgrade, ensure that the battery is
fully charged and the charger is plugged in.
To perform a software upgrade:
1. Remove the battery. See ‘To remove the battery’ on
page 3-20 for more information.
2. Remove the microSD card that captures the error log files
from the device (lightly push the SD card holder and pull out
the SD card).
3. Insert the application software microSD card.
Figure 6-3.
6-12
Insert SDcard
Vscan Extend – User Manual
5721203-100 Rev. D
Upgrade software
Scanner software (continued)
4. Press Settings on the Menu screen.
5. Press System Settings.
6. Press Upgrade Software.
The following message displays:
Current software version is:
New software version is:
7. Press OK to proceed with the upgrade.
NOTE:
You cannot upgrade the Scanner software to a software version
lower than the currently installed software. If you try to do so, a
message displays: “Not allowed to proceed”.
The Vscan Extend may have security patches which need an
update.
WARNING
GE is not responsible for any virus affecting the Vscan Extend
device which may result in data loss.
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6-13
Vscan Extend Maintenance
Troubleshooting
Vscan Extend troubleshooting
Table 6-2:
Problem
Vscan Extend has no power.
Vscan Extend is not charging.
Troubleshooting
Possible cause
Solution
Battery not inserted.
Insert battery (see page 3-20)
Battery not charged.
Charge the battery (see
page 3-18)
Battery defect or end of life.
Contact GE Service (see
page 1-10)
Broken battery connection.
Contact GE Service (see
page 1-10)
Battery not inserted.
Insert battery (see page 3-20)
Battery defect or end of life.
Contact GE Service (see
page 1-10)
Broken battery connection.
Contact GE Service (see
page 1-10)
Defective AC adapter or charger.
Contact GE Service (see
page 1-10)
Mains power is down.
Temperature is outside the
specified limits.
Ensure the ambient temperature
is within the specified limits (see
‘Environmental requirements for
the device’ on page 3-3)
Display screen is blank when the
device is powered on.
Connection broken during
software loading.
Contact GE Service (see
page 1-10)
Parts of the image is missing
when scanning.
Channels are missing.
Contact GE Service (see
page 1-10)
Noise when moving the probe
cable.
Defective probe cable.
Contact GE Service (see
page 1-10)
No image displayed when
scanning.
Defective probe.
Contact GE Service (see
page 1-10)
6-14
Vscan Extend – User Manual
5721203-100 Rev. D
Troubleshooting
Table 6-2:
Troubleshooting (Continued)
Problem
Possible cause
Vscan Extend display is flashing
while scanning.
Automatic reduction of the frame
rate due to increase of the
operating temperature after
extended scanning.
Restart the Vscan Extend to
restore the normal frame rate.
Battery may not have sufficient
charge.
Charge the Vscan Extend battery
for at least 60 minutes.
Vscan Extend is not entering the
scan screen and stays on the GE
start-up screen.
Vscan Extend – User Manual
5721203-100 Rev. D
Solution
NOTE: To maintain the operating
temperature of the Vscan Extend
at an optimal functional level, it is
recommended to hold the Vscan
Extend so there is good contact
between the device and the hand.
This will also ensure a longer
scanning time with maximum
frame rate
6-15
Vscan Extend Maintenance
System Warning Messages
System errors
•
System overheats
System is overheating and will shut down.
WARNING
If the problem persists, contact GE service.
•
Probe overheats
Probe is overheating and the system will shut down.
WARNING
If the problem persists, contact GE service.
•
Battery low
Battery is critically low or below 15%.
WARNING
Plug in charger.
•
WARNING
System voltage critical
System voltage is at critical level and will shut down.
If the problem persists, contact GE service.
6-16
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5721203-100 Rev. D
Troubleshooting
System Warning Messages (continued)
•
Connectivity error
Unable to connect.
WARNING
Check Wi-Fi connection.
•
Acquisition level
Check battery and recharge the system.
WARNING
If the problem persists, contact GE service.
System messages
•
Perform system backup
System internal memory usage is 50 to 60%.
WARNING
Perform system backup.
•
Scanning not allowed
WARNING
Scanning is not allowed when AC is connected.
WARNING
Scanning is not allowed when connected to a PC.
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6-17
Vscan Extend Maintenance
6-18
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5721203-100 Rev. D
Chapter 7
Appendix
Contents:
‘Specifications’ on page 7-2
‘Acoustic Output Reporting Tables’ on page 7-3
‘Measurement accuracy’ on page 7-12
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5721203-100 Rev. D
7-1
Appendix
Specifications
Dimension and weight
System dimension and weight
•
Main unit (approximately): 170 x 78 x 21 mm
•
Weight (Main unit with Sector probe, without battery): 365g
•
Weight (Main unit with Dual probe, without battery): 400g
•
Battery Weight: 65g
Probe dimension and weight
•
Dimension (L x B x H) Sector Probe:129 x 32 x 25 mm
•
Dimension (L x B x H) Dual Probe: 129 x 39 x 28 mm
•
Sector probe Weight (including cable): 85g
•
Dual probe Weight (including cable): 120g
Phased array transducer for deep scanning
•
Field-of-view for black and white imaging: up to 70 degrees
with maximum depth of 24 cm
•
The color flow sector represents blood flow within an angle
of 40 degrees.
•
Broad-bandwidth sector probe: from 1.7 to 3.8 MHz
•
Footprint: 13 x 19 mm
Linear transducer for shallow scanning
7-2
•
Field-of-view for black and white imaging: aperture width of
2.9 cm with maximum depth of 8 cm
•
The color flow sector represents blood flow over image with
full aperture and entire depth.
•
Broad-bandwidth linear probe: from 3.3 to 8.0 MHz
•
Footprint: 9 x 35 mm
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5721203-100 Rev. D
Acoustic Output Reporting Tables
Acoustic Output Reporting Tables
Definitions, symbols and abbreviations
The following definitions, symbols and abbreviations are used in
the acoustic output reporting tables in this chapter:
Table 7-1:
IEC
FDA
Definitions, symbols and abbreviations
Meaning—IEC 60601-2-37 / FDA & NEMA UD2, UD3
Acoustic Attenuation Coefficient / Derating factor (usually 0.3 dB/cm-MHz)
-12db Output Beam Area / Active aperture area
Normalizing Coefficient
Equivalent Aperture Diameter / (same)
Pulse Beam Width / Beam diameter at –6 dB
Equivalent Beam Diameter
Acoustic Working Frequency / Center frequency
Pulse-Average Intensity
Attenuated Pulse-Average Intensity
Pulse-Intensity Integral
Attenuated Pulse-Intensity Integral
Temporal-Average Intensity
Attenuated Temporal-Average Intensity / (at depth z)
Spatial-Peak Temporal-Average Intensity
Attenuated Spatial-Peak Temporal-Average Intensity
Mechanical Index
Output Power / Time average acoustic power at the source
Attenuated Output Power / Time average acoustic power derated to depth z
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5721203-100 Rev. D
7-3
Appendix
Table 7-1:
IEC
FDA
Definitions, symbols and abbreviations (Continued)
Meaning—IEC 60601-2-37 / FDA & NEMA UD2, UD3
Bounded Output Power / Power emitted from the central 1cm of aperture
Pulse Pressure Squared Integral / Pulse intensity integral
Peak-Rarefactional Acoustic Pressure / (same)
Attenuated Peak-Rarefactional Acoustic Pressure / (same)
Pulse Repetition Rate / Pulse repetition frequency
Thermal Index / (same)
Bone Thermal Index / (same)
Cranial-Bone Thermal Index / (same)
Soft-Tissue Thermal Index / (same)
Pulse Duration / (same)
-12 dB Output Beam Dimensions / (same)
Distance from the Source to a Specified Point / (same)
Depth for TIB / Depth at which the relevant index is maximum
Break-Point Depth / (same)
Depth for TIS / Depth at which the relevant index is maximum
7-4
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5721203-100 Rev. D
Acoustic Output Reporting Tables
Explanation of Footnotes
The mechanical and thermal indices may be replaced by one of
the following footnotes because of the reasons listed:
•
a: Display of this index is not required for this operating
mode.
•
b: This probe is not intended for transcranial or neonatal
cephalic uses.
If so, the table entries are replaced by a “#”, meaning: no data
are provided for this operating condition since the maximum
reported value is not reported for the reason listed.
If neither an index or a footnote is given, this means that the
index is irrelevant for this probe/mode combination.
Operating Conditions
All table entries are with the operating conditions specified at the
end of the table.
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5721203-100 Rev. D
7-5
Appendix
Acoustic Output Reporting Tables for Track 3/EN/IEC 60601-2-37
Dual Probe
Phased array transducer
Operating Mode: black/white
Figure 7-1.
7-6
Phased array transducer - black/white
Vscan Extend – User Manual
5721203-100 Rev. D
Acoustic Output Reporting Tables
Dual Probe
Phased array transducer
Operating Mode: black/white and color
Figure 7-2.
Phased array transducer - black/white and color
Vscan Extend – User Manual
5721203-100 Rev. D
7-7
Appendix
Dual Probe
Linear array transducer
Operating Mode: black/white
Figure 7-3.
7-8
Linear array transducer - black/white
Vscan Extend – User Manual
5721203-100 Rev. D
Acoustic Output Reporting Tables
Dual Probe
Linear array transducer
Operating Mode: black/white and color
Figure 7-4.
Linear array transducer - black/white and color
Vscan Extend – User Manual
5721203-100 Rev. D
7-9
Appendix
Sector probe
Phased array transducer G3S
Operating Mode: black/white
Figure 7-5.
7-10
Phased array transducer - black/white
Vscan Extend – User Manual
5721203-100 Rev. D
Acoustic Output Reporting Tables
Sector probe
Phased array transducer G3S
Operating Mode: black/white and color
Figure 7-6.
Phased array transduce - black/white and color
Vscan Extend – User Manual
5721203-100 Rev. D
7-11
Appendix
Measurement accuracy
Basic Measurements
The following information is intended to provide guidance to the
user in determining the amount of variation or measurement
error that should be considered when performing clinical
measurements with this equipment. Error can be contributed by
equipment limitations and improper user technique. Be sure to
follow all measurement instructions and develop uniform
measurement techniques among all users to minimize the
potential operator error. Also, in order to detect possible
equipment malfunctions that could affect measurement
accuracy, a quality assurance (QA) plan should be established
for the equipment that includes routine accuracy checks with
tissue mimicking phantoms.
Please be advised that all distance and Doppler related
measurements through tissue are dependent upon the
propagation velocity of sound within the tissue. The propagation
velocity usually varies with the type of tissue, but an average
velocity for soft tissue is assumed. This equipment is designed
for, and the accuracy statements listed on are based on, an
assumed average velocity of 1540 m/s. The percent accuracy
when stated applies to the measurement obtained (not the full
scale range). Where the accuracy is stated as a percent with a
fixed value, the expected inaccuracy is the greater of the two.
Table 7-2:
Measurement
Unit
Measurement accuracy
Useful range
Accuracy
Probe
Distance
Axial
cm
Full screen
±3% or ±1 mm,
whichever is greater
Both probes
Lateral
cm
Full screen
±5% or ±1 mm,
whichever is greater
Shallow
7-12
Vscan Extend – User Manual
5721203-100 Rev. D
Measurement accuracy
Speed of Sound in Tissue
The average value 1540 meters / second is used for all
calculations. Depending on the tissue structures, this
generalization may give errors from 2% (typical) to 5% (much
fatty tissue layers present).
Vscan Extend – User Manual
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7-13
Appendix
7-14
Vscan Extend – User Manual
5721203-100 Rev. D
Chapter 8
Privacy and Security
Contents
‘Introduction’ on page 8-2
‘Privacy and Security Environment’ on page 8-3
‘Privacy and Security Capabilities’ on page 8-3
‘Network Connectivity’ on page 8-6
‘Information Protection’ on page 8-9
‘Personal Information Collected by the Product’ on
page 8-17
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5721203-100 Rev. D
8-1
Privacy and Security
Introduction
Overview
This chapter describes Privacy and Security considerations for
the use of the Vscan Extend. It describes the expected intended
use, the Privacy and Security capabilities included, and how
they are configured and used appropriately.
This chapter assumes that the reader understands the concepts
of Privacy and Security. Privacy is the property of protecting the
personal private interests of patients. Security protects both
system and information from risks to confidentiality, integrity,
and availability. Security protects Privacy but also protects more
broadly against these risks. Privacy requires security. In
Healthcare one must balance privacy, security, and safety. Most
of the time there isn’t a conflict between these three domains of
risk. The healthcare provider organization is encouraged to use
risk management procedures to assess and prioritize privacy,
security, and safety risks. Through the use of risk management
one can determine how to best leverage the capabilities
provided in the Vscan Extend Ultrasound product.
How to contact GE
For privacy and security concerns regarding GE products,
please see: http://www.ge.com/security
8-2
Vscan Extend – User Manual
5721203-100 Rev. D
Introduction
Privacy and Security Environment
The GE Healthcare Vscan Extend Ultrasound product has been
designed for an intended use with the following expectations of
Privacy and Security protections included in the environment
where this product will be used:
1. The system should be connected to a secured network, not
open to unintended users.
2. The Vscan Extend should be physically secured in a way
that it is not accessible for unintended users.
3. The Vscan Extend supports device PIN-based
management.
4. External media (microSD card) containing images, patient
data, reports and logs should be secured. When no longer
used, the data should be securely erased and/or the media
should be securely deleted.
5. The display of the Vscan Extend should be placed in a way
limiting the visibility to the user only.
Privacy and Security Capabilities
The GE Healthcare Vscan Extend incorporates a broad
assortment of capabilities to enable Privacy and Security. This
section describes the capability and use of these Privacy and
Security capabilities.
Access Controls
The access control features may be used to help control access
to sensitive information. Access control includes user account
creation and assigning privileges.
Identity Provisioning
The Vscan Extend device supports PIN authentication. A PIN is
created by the user when accessing the device and storing the
image for the first time.
The device provides PIN access at two levels:
1. Storage access
2. Admin access
The user MUST set the Admin PIN when trying to access the
Admin mode.
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5721203-100 Rev. D
8-3
Privacy and Security
PIN restrictions
The restrictions on a PIN are:
1. The PIN should be 4-digits long.
2. When the device is idle for a certain amount of time set in
the session duration, it is the reponsibility of the user to
ensure that the device is not used by unauthorized
individuals as it may lead to data loss.
User Authentication
The Vscan Extend device is operated using a PIN. Only one PIN
is used by different users to access the device. The Vscan
Extend does not support user profiles.
Assigning Access Rights
The Admin mode is used to change the System level
configuration.
A user can access the Admin mode by entering the Admin PIN.
Patient Privacy Consent Management
Patient Privacy Consent Management is the process to support
the patient to express their privacy requirements. This is
different from other forms of consent such as the consent to
treat.
There is no integrated functionality in the system for Patient
Privacy Consent Management. If needed, operational routines
must be established.
Privacy and Security Audit Logging and Accountability Controls
Privacy and Security Audit Logging and Accountability Controls
support Security surveillance and Privacy investigations and
reporting.
The Vscan Extend has an integrated functionality for audit
logging, including audit logging of privacy related events.
8-4
Vscan Extend – User Manual
5721203-100 Rev. D
Introduction
Audit logging content
The following events are captured by the audit logging of the
Vscan Extend:
1. Device Start/Shut-down time
2. Incorrect password attempts
3. Addition and Modifications to system configuration,
including:
a. DICOM connection
b. Windows Share connection
c.
Application software installation/uninstallation/software
upgrade
d. Registration of partnering apps
4. Events related to Patient Data, including details of:
e. Data access Date/Time including type of action
(addition, deletion, modification, reviewed) excluding
the PC connect scenario
f.
Details of applications used (Bladder app, Lung
protocol, etc.)
5. Data Export
a. Data export Date/Time including end point and Wi-Fi
SSID information
b. Data Backup/Restore detail
6. Invalid Device PIN attempt
7. Kiosk admin mode login success and failure
Management of Audit logs
Back up of audit logs
Back up of audit logs can be done by exporting audit logs to an
external device. The export happens through USB export.
Remember that audit logs and exported audit log files do contain
Personal Information (PI) and must be handled according to
applicable regulations and guidelines for handling of PI/PHI.
Note that exported audit log files are stored unencrypted.
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8-5
Privacy and Security
Network Connectivity
Overview
Network connection for the Vscan Extend is required by several
system features:
1. DICOM connectivity to other DICOM devices
2. Disk Management/Backup towards Windows share
3. Image/Video storage via the “JPG/MPEG” feature
System interconnections
The figure below shows the possible interconnections for the
Vscan Extend Ultrasound system. For a particular installation,
typically a subset of the interconnections is utilized.
Figure 8-1.
1.
2.
3.
4.
8-6
GE Health Cloud
Hospital Public Wireless infrastructure
Vscan Extend Device
Hospital Clinical Network
Vscan Extend network diagram
5. PACS
6. Hospital Clinical Wireless infrastructure
7. Windows PC
Vscan Extend – User Manual
5721203-100 Rev. D
Network Connectivity
System interconnections (continued)
Device features
•
Supported Wireless
Protocols include WEP, WPA2 with PSK and EAP with
certificates
•
Log files
•
Data backup/restore
•
Software upgrade
Wireless Networks are configured by Hospital IT administrators
or device owners. The Wi-Fi encryption depends upon on the
hospital IT infrastructure and the device enterprise grade
protocols with the certificate mechanism.
DICOM image transfer and anonymized images/video transfer
to a Windows machine is supported over a hospital clinical
wireless network and a hospital public wireless service that are
used for GE cloud connectivity to push the data using SSL/TLS.
The table below describes interconnections in more detail:
Table 8-1:
Source/destination
Interconnections
Network service
Description
PACS/DICOM server
DICOM
Optional connection to PACS/DICOM server
for patient and image archiving/retrieval.
DICOM storage, DICOM Query/Retrieve and
DICOM Worklist are supported
Windows share
Windows file sharing
Some dataflows can be configured to use a
windows share as output. This includes
MPEG, videos.
USB export
USB cable
If the feature is enabled, an USB cable can be
connected to a PC for exporting images and
videos.
For details regarding protocols, port numbers and firewall
configurations see ‘Inbound firewall configuration’ on page 8-10,
‘Outbound firewall configuration’ on page 8-11.
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8-7
Privacy and Security
Network Requirements
Host Characteristic
1. TCP/IP network
2. Both DHCP and static IP allocation are supported
Network Protocols
Wireless network protocols
The following wireless protocols are supported:
1. IEEE 802.11b
2. IEEE 802.11g
3. IEEE 802.11n
Internet Protocol Version:
1. IPv4
2. IPv6
8-8
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5721203-100 Rev. D
Information Protection
Information Protection
Overview
This section of the manual focuses on Privacy and Security
operations, and contains information to guide in the preparation
of a secure environment for the Vscan Extend Ultrasound
system.
Security operations is best implemented as part of an overall
“defense in depth” information assurance strategy; this is used
throughout an Information Technology system that addresses
personnel, physical security and technology. The layered
approach of defense in depth limits the risk that the failure of a
single security safeguard will allow compromise of the system.
Network Security
GE strongly recommends that medical information systems are
operated in a secure network environment that is protected from
unauthorized intrusion. There are many effective techniques for
isolating and protecting medical information systems, including
implementing firewall protection, demilitarized zones (DMZs),
Virtual Local Area Networks (VLANs) and network enclaves.
To assist in secure network design, the following network profile
outlines the required network services for the Vscan Extend
Ultrasound system.
The Vscan Extend is supported with an internal firewall. The
following two sections describe the configuration of the firewall
and the guidance for configuring the IT infrastructure where it is
connected.
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5721203-100 Rev. D
8-9
Privacy and Security
Inbound firewall configuration
All inbound connections are blocked by the Vscan Extend
Ultrasound system’s internal firewall, with the exemptions listed
in the table below.
The column “Recommended configuration of network
infrastructure” describes the suggested configuration of the
network infrastructure regarding the different network services.
Table 8-2:
Local port
1041
Remote
port
Any
Inbound Firewall configuration
Protocol
TCP
Programs
All
Recommended
configuration of
network
infrastructure
Open to DICOM
server(s)
connected to the
Vscan Extend, but
only if DICOM
Retrieve is used.
Closed towards
internet.
Network
service
DICOM
Retrieve
from
connected
DICOM
server(s)
Port 104 or another port configured for the DICOM Retrieve service.
8-10
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5721203-100 Rev. D
Information Protection
Outbound firewall configuration
All outbound connections are blocked by the Vscan Extend
Ultrasound system’s internal firewall, with the exemptions listed
in the table below.
The column “Recommended configuration of network
infrastructure” describes the suggested configuration of the
network infrastructure regarding the different network services.
Table 8-3:
Local port
Remote
port
Inbound Firewall configuration
Protocol
Programs
Recommended
configuration of
network
infrastructure
Network
service
Any
1042
TCP
DICOM
Open to DICOM
server(s)
connected to the
Vscan Extend.
Closed towards
internet.
DICOM
store
Any
1043
TCP
DICOM
Open to DICOM
server(s)
connected to the
Vscan Extend, but
only if DICOM
Query is used.
Closed towards
internet.
DICOM
Query
Any
1044
TCP
DICOM
Open to DICOM
server(s)
connected to the
Vscan Extend, but
only if DICOM
Worklist is used.
Closed towards
internet.
DICOM
Worklist
Any
445
TCP
Windows
Share
Windows
Windows
Share
Port 104 or another port configured for the DICOM Storage service.
Port 104 or another port configured for the DICOM Query service.
Port 104 or another port configured for the DICOM Worklist service.
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8-11
Privacy and Security
Local Archive - Security capabilities
The Vscan Extend is provided with an internal archive, for
storing images and patient data locally on the system. The local
archives file repository and patient database do not support file
sharing or remote connection. These can only be accessed
locally.
The patient database is protected with the authentication for
access requirements and no possibility of remote access.
DICOM connections – Security capabilities
The DICOM connection works as defined by DICOM guidelines.
The application accepts connection only to/from DICOM entities
with IP-address, AE Title and port number matching the
configured parameters in the Vscan Extend Ultrasound system.
The communication sessions are on demand and are always
initiated locally from the system.
The Vscan Extend Ultrasound system’s internal firewall has
exemptions for ports used by the defined DICOM dataflows in
the system. Defining a new DICOM dataflow, or changing an
existing dataflow, will cause the internal firewall configuration to
automatically change. This ensures that only ports configured
for a dataflow have an exemption in the internal firewall.
Windows share
Windows share access can be secured by defining a dedicated
user on the server side. The user credentials for the network
share user must be entered in the configuration UI on the Vscan
Extend Ultrasound system.
NOTE:
There is no network file share on the Vscan Extend Ultrasound
system.
Network infrastructure
The infrastructure of the network where the Vscan Extend is
connected must be configured to allow traffic as described in
Inbound firewall configuration and Outbound firewall
configuration sections. All other traffic to and from the Vscan
Extend can be blocked in the network infrastructure to prevent
unintended access.
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Information Protection
Wireless Security
Due to the broadcast nature of wireless communication,
wireless devices require special security considerations. There
are effective techniques and tools for improving the security of
wireless communication devices.
Wireless security protocols
The following security protocols are supported on the wireless
interface:
1. WEP
2. WPA/WPA2 PSK
3. 802.1x EAP - (PEAP, TLS, TTLS, PWD, SIM, AKA)
Removable Media Security
Data stored on removable media, such as a microSD card, is
stored encrypted on the media. The storage device and the
content on the storage device must be physically protected and
handled according to applicable regulations and guidelines for
handling personal information (PI) / protected health information
(PHI).
Data can also be exported through a USB cable to a PC. Only
the images or videos will be exported. The patient information
will not be displayed.
Removable media on the Vscan Extend Ultrasound system
The Vscan Extend supports USB cable connection to export
images and videos to a PC.
The removable microSD cards are used for the following:
1. Backup encrypted patient data – empty microSD card
2. Error log storage – original microSD card delivered with the
Vscan Extend
3. Upgrade the application software – Application microSD
card
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5721203-100 Rev. D
8-13
Privacy and Security
Data destruction for portable media
The Vscan Extend does not have the internal functionality to
securely delete data stored on the removable devices.
Approved procedures and tools should be used to securely
remove data stored on removable media, according to
applicable regulations and guidelines for handling patient
information / personal information (PI) / protected health
information (PHI).
Data at Rest Security
Patient data is encrypted and images/videos/logs are
unencrypted.
Back-up
The Vscan Extend backup feature stores data in an encrypted
format. Only images are backed up; no patient information is
displayed.
The backup device must be secure, whether it is removable
media or a server, to ensure no unauthorized intrusion.
External dataflows
The Vscan Extend supports interconnections to external storage
systems. This includes connections to Remote Archives
(Windows Share) and DICOM servers. The security of data
stored on these systems must be secure.
d on the external storage system (outside the scope of the
Vscan Extend Ultrasound system).
Data Integrity Capabilities
To ensure the integrity of any software update, the Vscan
Extend has additional security installed to detect any malicious
modifications to a software update package.
Integrity assurance is implemented to software updates
packages for the Vscan Extend Ultrasound system. Malicious
modifications to a software update packages will be discovered
at install time, and the installation of the malicious software will
be prohibited.
The Vscan Extend has integrated audit log capabilities that logs
changes to the data. See ‘Privacy and Security Audit Logging
and Accountability Controls’ on page 8-4 for more information.
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Information Protection
Business Continuity
To ensure business continuity, several options must be
considered related to data storage. The target for the images
and patient archive must be chosen to ensure safe storage of
the data. Both internal and external alternatives are supported.
Patient archive solutions
The Vscan Extend supports several alternatives for storing
images and patient information, both internal and external:
1. Local Archive: local storage on the Vscan Extend
Ultrasound system
2. Remote Archive: Only anonymized images can be stored on
Windows share. Patient information is not visible.
3. DICOM storage: storage on DICOM/PACS server
See ‘System interconnections’ on page 8-6 for more information.
Securing data on Local Archive and Local Archive Shared
If local archive is used, backup and/or transfer procedures must
be established for the local archive. If disk management is not
performed within a pre-defined period, a warning message
displays.
Securing data on Remote Archive and DICOM/PACS servers
If external archive is used, a backup procedure must be
established for the external archive. The business contingency
planning of data stored on DICOM/PACS servers is outside the
scope of this document.
Off-line mode
The Vscan Extend can operate in stand-alone mode, with the
use of Local Archive. If there are data network related problems,
which prevents the Vscan Extend from connecting to an external
patient archive, the device can be fully functional by storing
patient data/images to the Local Archive.
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8-15
Privacy and Security
System Protection
Vscan Extend – system protection
The System needs to be configured and maintained in a way
that continually protects Privacy and Security.
The GE Healthcare Vscan Extend contains additional features
to improve local operational security.
No system access
Users of the Vscan Extend do not have access to the Android
system nor to the MST system (Linux) on the Vscan Extend
Ultrasound system.
Hence the users will have no access to internet web-browsing,
e-mail clients, installing any software on the system nor adding
files (except for application related files through the application)
Android features controlled
Android operating system is controlled through an Admin PIN.
The user does not have access to the Android system.
Vscan Extend operating system
Table 8-4:
Family
Vscan Extend
Operating system
Product
DaVinci 6446 / 128MB / 64MB; Android 4.4.2/ 1.5 GB
The Vscan Extend is based on Android and Linux operating
systems, but have been customized for Ultrasound use.
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Personal Information Collected by the Product
Personal Information Collected by
the Product
Information collection and use
The Vscan Extend collects patient demographic information,
personal and/or protected health information for the use within
the system.
Information entered for users defined in application user
management is also stored on the system.
The following types of information are collected for the purposes
of patient medical diagnosis, user management, audit logging
and/or debug logging:
1. Patient demographics
2. Medical diagnostics and measurements
3. Ultrasound images
4. Facility information
5. Provider information
6. Device data
Patient information collected is either entered manually by the
user or is received through one or more of the system’s
dataflows.
Details on what data is collected, used and disclosed can be
obtained by contacting GE Healthcare.
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8-17
Privacy and Security
Manual information collection
Only PI required for the purpose of treatment or healthcare
operations should be collected. The system supports collection
of PI that is related for such usage only. However the system
might support collection of more data than will be used for a
particular installation. The user should limit the collect of PI to
what is really needed.
Only PI required for the purpose of treatment or healthcare
operations should be collected. Even though the Vscan Extend
supports PI collection for treatment or healthcare operaitons, the
system might support collection of more data than is needed for
a particular installation. Limit the PI collection to the content
needed.
The user should not enter personal identifiable information in
free text fields on the system as this information is not
anonymized by the de-identification procedure.
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Personal Information Collected by the Product
Information disclosure
If the Vscan Extend is connected to external archives, patient
demographics, medical diagnostics, measurements and
ultrasound images will be communicated to/from the external
archives. The same applies for remote network shares and
external media, like a microSD card and USB cable used to
export images to a PC. See ‘System interconnections’ on
page 8-6 for more information.
Retention and destruction of personal information
Retention and destruction of patient data
The information collected is stored on the system until it is
manually removed.
Requirements and policies for limited collection and/or
destruction of Patient Information on the system must be
implemented by establishing appropriate procedures. There is
no support for such functionality in the system.
Retention and destruction of user information, local users
User information created and managed on the device remains
on the system until manually removed.
Requirements and policies for limited collection and/or
destruction of user information on the system must be
implemented by establishing appropriate procedures. There is
no support for such functionality in the system.
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8-19
Privacy and Security
Protection of personal information
Individuals authorization for collection, use and disclosure of PI/PHI
Some users of Vscan Extend system might face requirements
and policies for letting individuals (the patients) authorize the
collection, use and disclosure of PI/PHI. There is no support for
such functionality in the system. Such requirements can only be
implemented by operational procedures.
Information to individuals of collection, use and disclosure of PI/PHI
Some users of the Vscan Extend may have certain requirements
and policies to inform individuals (patients) about the collection,
use and disclosure of PI/PHI. There is no support for such
functionality in the system. Such requirements can only be
implemented by procedures.
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Personal Information Collected by the Product
Potential Hazardous Situations Resulting From Failures of the IT
Network
Hazardous situations
The following situations have been identified as potentially
hazardous as a result of the IT network failing to provide the
required characteristics specified above.
1. Delayed or impaired access to images or other exam
information or patient data.
2. Permanent loss of images or other exam information or
patient data.
3. Corruption of images or other exam information or patient
data.
Warning
In addition to the hazardous situations identified above,
connection of the Vscan Extend to a network that includes other
equipment could result in other unidentified risks to patients,
operators or third parties. The responsible organization should
identify, analyze, evaluate and control these risks on an ongoing
basis. Re-evaluate the risks if any of the following occurs:
1. Changes in network configuration
2. Connection of additional items to the network
3. Disconnecting items from the network
4. Update of equipment connected to the network
5. Upgrade of equipment connected to the network
Vscan Extend – User Manual
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8-21
Privacy and Security
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5721203-100 Rev. D
Index
Activating Wi Fi, 4-21
Appendix, 7-1
Audit logs
audit logs, 5-30
Auto freeze, 5-23
AutoCycle, 5-23
Lung Protocol
Lung Protocol, 5-54
Battery
Charge, 3-15
Level indicator, 3-19
Removing / inserting the battery (VE-BAT), 3-20
specifications, 3-21
Black and white imaging, 5-17
Bladder Volume
Bladder Volume, 5-47
Package contents, 3-2
Patient examination, 5-7
Power on/off, 3-22
Preparing Vscan ExtendTM for Use, 3-1
Probe and Presets, 5-12
Certificate Authority, 4-28
Cleaning and disinfection, 6-4
Color Aliasing, 5-22
Color imaging (option), 5-20
Configuring Wi Fi, 4-23
Measurements, 5-24
Regulatory Requirements, i-3
Review and recall of stored data, 5-26
External battery charging compartment (option), 3-11
Safety
Acoustic output, 2-19
Device labels and symbols, 2-25
Electrical Hazard, 2-7
Electrical hazard, 2-8
Electromagnetic Compatibility (EMC), 2-10
Explosion hazard, 2-7
Maximum probe temperature, 2-24
Mechanical hazards, 2-6
Pacemaker hazard, 2-8
Patient Safety, 2-5
Personnel and equipment safety, 2-7
Scanning, 5-2
Settings, 4-2
System description, 3-4
Indication for use, 1-4, 1-5
Information
Requesting, 1-10
Inspection, 6-3
Tricefy, 5-62
Troubleshooting, 6-14
Data export
data export, 5-30
Deletion of data, 5-28
DICOM
DICOM, 5-36
Upgrade application software, 6-12
USB export
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5721203-100 Rev. D
Index-1
USB export, 5-31
Using Vscan Extend, 5-1
Voltage requirements, 3-17
Vscan Extend Battery, 3-15
Vscan Extend Maintenance, 6-1
Vscan Extend Settings, 4-1
Index-2
Vscan Extend – User Manual
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