Vivid iq User Manual Ver R1.x.x Rev 05 Dec 2016

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 Vivid iq ultrasound systems, hereafter referred to as Vivid iq. It applies to all revisions of the R1.x.x software for the Vivid iq ultrasound system.

GE P.O. Box 414, Milwaukee, Wisconsin 53201 U.S.A (Asia, Pacific, Latin America, North America) GE Ultraschall Deutschland GmbH & Co. KG Beethovenstrasse 239 Postfach 11 05 60 D-42655 Solingen GERMANY TEL: 49 212.28.02.208; FAX: 49 212.28.02.431

Revision History Reason for change DATE (YYYY-MM-DD)

REV

REASON FOR CHANGE

Rev. 01

2016/05/10

Initial Release

Rev. 02

2016/05/28

Update application list and add ICE probe information

Rev. 03

2016/08/31

Update software features and add UDI label

Rev. 04

2016/10/12

Update certifications and device label

Rev. 05

2016/12/19

Add WLAN configuration information

List of Effective Pages

Chapter

REVISION NUMBER

Chapter

REVISION NUMBER

Title Page

Rev. 05

Chapter 8

Rev. 05

Revision History

Rev. 05

Chapter 9

Rev. 05

Regulatory Requirements

Rev. 05

Chapter 10

Rev. 05

Table of Contents

Rev. 05

Chapter 11

Rev. 05

Chapter 1

Rev. 05

Chapter 12

Rev. 05

Chapter 2

Rev. 05

Chapter 13

Rev. 05

Chapter 3

Rev. 05

Chapter 14

Rev. 05

Chapter 4

Rev. 05

Chapter 15

Rev. 05

Chapter 5

Rev. 05

Chapter 16

Rev. 05

Chapter 10

Rev. 05

Index

Rev. 05

Chapter 7

Rev. 05

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.

Vivid iq – User Manual 5723892-100 Rev. 05

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Regulatory Requirements

Conformance Standards The following classifications are in accordance with the IEC/ EN 60601-1: •

According to 93/42/EEC Medical Device Directive, this is Class IIa Medical Device.

•

According to IEC/EN 60601-1,

•

•

Equipment is Class I, Type BF or CF Applied Parts.

•

Continuous Operation

According to CISPR 11, •

•

Equipment is Group 1, Class A ISM Equipment.

According to IEC 60529, •

The footswitch rate IPx8 is suitable for use in surgical rooms.

•

Probe head (immersible portion) and cable are IPX7. Probe connector is not waterproof. System is Ordinary Equipment (IPX0).

This product complies with the regulatory requirement of the following: •

Council Directive 93/42/EEC concerning medical devices: 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. Authorized EU Representative European registered place of business: GE Medical Systems SCS 283 rue de la Minière 78530 BUC, France

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Vivid iq – User Manual 5723892-100 Rev. 05

Conformance Standards (continued) •

•

International Electrotechnical Commission (IEC). •

IEC/EN 60601-1 Medical Electrical Equipment, Part 1 General Requirements for Safety.

•

IEC/EN 60601-1-2 Electromagnetic compatibility Requirements and tests.

•

IEC/EN 60601-1-6 (Usability), EN 1041 (Information supplied with medical devices)

•

IEC/EN 60601-2-37 Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment.

International Organization of Standards (ISO) •

ISO 10993-1 Biological evaluation of medical devices.

•

ANSI/AAMI ES60601-1 Medical Electrical Equipment, Part 1 General Requirements for Safety.

•

Canadian Standards Association (CSA). •

CSA 22.2, 601.1 Medical Electrical Equipment, Part 1 General Requirements for Safety.

•

NEMA/AIUM Acoustic Output Display Standard (NEMA UD3).

•

Medical Device Good Manufacturing Practice Manual issued by the FDA (Food and Drug Administration, Department of Health, USA).

•

General Electric Medical System is ISO13485 certified.

•

General Electric Medical Systems Ultrasound and Primary Care Diagnostics is ISO 9001 and ISO 13485 certified.

Certifications

Original Documentation The original document was written in English.

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Country Specific Approvals •

JAPAN MHLW Approved Number: 228ABBZX00125000

Importer Information Turkey

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Vivid iq – User Manual 5723892-100 Rev. 05

Table of Contents

Conformance Standards - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-2 Certifications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-3 Original Documentation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-3 Country Specific Approvals - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-4 Importer Information - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-4

Table of Contents Chapter 1 - Introduction Overview Attention - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-2 Documentation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-3 Principles of operation- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-4 Intended use - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-4 Indications for use- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-4 Frequency of use - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-4 Operator profile - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-5 Clinical Applications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-5 Contraindications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-5 Prescription device - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-6 Safety - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-6

Contact Information Contacting GE Ultrasound - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-7 Manufacturer - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-13 Factory Sites - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-13

Chapter 2 - Safety Safety Precautions Precaution Levels - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-2

Owner responsibility Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-3 Notice against user modification- - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-4 Regulatory information - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-4

Acoustic output Definition of the acoustic output parameters - - - - - - - - - - - - - - - - - - - - 2-5 Acoustic output display on the Vivid iq - - - - - - - - - - - - - - - - - - - - - - - - 2-7 ALARA - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-8 Training - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-8 Safety statement- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-8 System controls affecting acoustic output - - - - - - - - - - - - - - - - - - - - - - 2-9 OB Exam - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-11

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Important safety considerations Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-12 Patient safety - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-12 Personnel and equipment safety - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-16 Electromagnetic Compatibility (EMC) - - - - - - - - - - - - - - - - - - - - - - - - 2-22 Patient Environmental Devices- - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-34 Environmental protection - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-36

Device labels Label Icon Description- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-37 Label Locations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-45 Probe Label Explanation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-50 Probe Box Label - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-51 UDI Global Trade Item Number (GTIN) Label and Probe Box Barcode Locations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-51 RoHS Vivid iq Hazardous Substances - - - - - - - - - - - - - - - - - - - - - - - 2-53

Chapter 3 - Getting started Introduction Preparing the unit for use Before the system arrives - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-3 Site requirements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-4 Connecting the unit - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-6 Power On/Off - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-11 Locking/unlocking the LCD monitor - - - - - - - - - - - - - - - - - - - - - - - - - 3-14 LCD monitor position adjustment - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-15 LCD Monitor Brightness adjustment - - - - - - - - - - - - - - - - - - - - - - - - - 3-16 Cart Adjustment - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-16

Moving and transporting the unit Moving the unit - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-18 Transporting the unit - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-18 Reinstalling at a new location- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-19

System description System overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-20

Starting an examination Creating a new patient record - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-57 Selecting an existing patient record - - - - - - - - - - - - - - - - - - - - - - - - - 3-58 Scanning a New Patient - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-59 Ending an examination - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-62

Chapter 4 - Basic operations Control Panel Mode/Measurement/Feature keys - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-2

Operation on Touch Screen Monitor Display- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-4

Removable media Intended use - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-9 Supported removable media - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-10 About removable media and long-term image storage - - - - - - - - - - - - 4-11 Recommendation concerning CD and DVD handling - - - - - - - - - - - - - 4-11

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Formatting removable media - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-12 Ejecting removable media - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-15

Physiological ECG traces Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-16 ECG - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-17 Using Physios - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-18

Cineloop Cineloop overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-21

Zoom Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-24 Display zoom - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-24 HR zoom - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-24

Annotations Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-25 To insert an annotation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-25 Editing annotations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-28 To erase annotations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-29 Bodymark - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-29 Annotation and bodymark configuration - - - - - - - - - - - - - - - - - - - - - - 4-30

Configuration – System and users About system Configuration - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-34 General system settings - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-36 Shortcut Bar configuration - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-38 Configuring the Wireless Network - - - - - - - - - - - - - - - - - - - - - - - - - - 4-39 System users - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-55

Chapter 5 - Scanning Modes 2D-Mode 2D-Mode overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-3 Using 2D-Mode - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-4 Optimizing 2D- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-4

M-Mode M-Mode overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-6 Using M-Mode - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-7 Optimizing M-Mode- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-8

Color Mode Color 2D Mode overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-9 Color M-Mode overview- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-10 Using Color Mode - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-10 Optimizing Color Mode - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-11

PW and CW Doppler PW and CW Doppler overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-13 Using PW/CW Doppler modes - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-14 Optimizing PW/CW Doppler modes - - - - - - - - - - - - - - - - - - - - - - - - - 5-14

Tissue Velocity Imaging (TVI) TVI overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-16 Using TVI- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-17 Optimizing TVI - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-17

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Tissue Tracking Tissue Tracking overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-18 Using Tissue Tracking- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-19 Optimizing Tissue Tracking - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-20

Strain rate Strain rate overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-21 Using Strain rate- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-22 Optimizing Strain rate - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-22

Strain Strain overview- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-23 Using Strain - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-24 Optimizing Strain - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-24

Tissue Synchronization Imaging (TSI) TSI overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-25 Using TSI- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-26

Additional scanning features LogiqView - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-28 Compound - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-29 B-Flow - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-29 Blood flow imaging - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-30 Virtual Convex - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-30

Image controls Image controls - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-31

Scan Assist Pro Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-39 Scan Assist Pro overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-39 Setting up Scan Assist Pro - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-40 Using Scan Assist Pro- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-43

Configuration – Imaging Global imaging settings - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-45 Application Preset- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-47 Application list configuration- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-47 Deleting an application preset - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-48 Generating a new preset - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-49 TEE probe configuration - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-52

Chapter 6 - 4D and Multi-plane Modes 4D-Mode Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-2 4D-Mode - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-3 4D Color Flow mode - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-12 Flexi-Slice - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-17 Basic operations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-19 4D-Mode controls - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-22

Multi-plane mode Multi-plane mode overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-26 Using Multi-plane mode- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-26 Basic operations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-28

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Multi-plane mode controls - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-31

Chapter 7 - Stress Echo Introduction Selection of a stress test protocol template Image acquisition Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-4 Starting acquisition - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-5 Continuous capture mode - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-9 Assigning and storing the loops - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-16

Stress Echo analysis Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-18 Image selection for analysis- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-18 Wall motion scoring- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-20

Quantitative TVI Stress echo analysis Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-23 Accessing QTVI Stress analysis tools - - - - - - - - - - - - - - - - - - - - - - - - 7-25 Vpeak measurement - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-25 To display a Vpeak measurement - - - - - - - - - - - - - - - - - - - - - - - - - - 7-26 Turn-off the Vpeak measurement tool - - - - - - - - - - - - - - - - - - - - - - - - 7-27 V-peak measurement interpretation - - - - - - - - - - - - - - - - - - - - - - - - - 7-28 Tissue Tracking - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-28 Quantitative analysis - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-28 References - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-29

Editing/creating a Stress Echo protocol template Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-30 Entering the Template editor screen - - - - - - - - - - - - - - - - - - - - - - - - - 7-31 Editing/Creating a template - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-32

Configuration Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-36

Chapter 8 - Contrast Imaging Introduction Data acquisition - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-2 Quantification - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-3 Useful link - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-4

Data acquisition Left Ventricular Contrast Imaging - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-5

Chapter 9 - Measurements and analysis Introduction General recommendations about measurements - - - - - - - - - - - - - - - - - 9-4 About Measurement results display - - - - - - - - - - - - - - - - - - - - - - - - - - 9-4

Assign and Measure modality Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-6

Measure and Assign modality Measurement Tool - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-8 Measurements on volume renderings - - - - - - - - - - - - - - - - - - - - - - - - - 9-9

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Measurements on protocol images Advanced cardiac measurements and analysis Naming Format for Cardiac Measurements - - - - - - - - - - - - - - - - - - - - 9-11 Event timing measurements- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-15 TSI Measurements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-16 Automated Function Imaging - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-23 AutoEF measurements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-45 Pediatric Z score measurement study - - - - - - - - - - - - - - - - - - - - - - - - 9-52

4D/Multi-plane LV measurements and analysis Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-54 4D Auto LVQ - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-54 Manual left ventricular volume measurements - - - - - - - - - - - - - - - - - - 9-65

4D Auto AVQ Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-70 Requirements- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-70 Starting the 4D Auto AVQ tool - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-71 Slice alignment - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-72 LVOT segmentation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-72 Measurements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-74 Approval - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-74

Advanced vascular measurements and analysis Naming format for vessels - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-75 Intima-Media Thickness- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-79

Pediatrics Calculations Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-84 Hip Dysplasia Calculation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-85 Making Hip Dysplasia Measurement- - - - - - - - - - - - - - - - - - - - - - - - - 9-86 Alpha HIP - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-87 d:D Ratio Measurement- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-88

OB measurements and calculations OB graphs - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-89

Measurement package configuration Basic operations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-93 Measurement package configuration - example - - - - - - - - - - - - - - - - - 9-95 User-defined formulas - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-97 Advanced settings - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-106 Normal values - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-112

Measurement result table Minimizing the Measurement result table - - - - - - - - - - - - - - - - - - - - 9-115 Moving the Measurement result table - - - - - - - - - - - - - - - - - - - - - - - 9-115 Deleting measurements- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-115

Worksheet Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-116 Using the Worksheet- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-116

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Chapter 10 - Quantitative Analysis Introduction Q Analysis overview Starting Q Analysis - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-3 Q Analysis screen- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-4

Using Q Analysis Generation of a trace - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-8 Saving/retrieving Q Analysis - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-13 Frame disabling - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-13 Optimization - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-15 Switching modes or traces- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-19 Anatomical M-Mode - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-20

Chapter 11 - Archiving Introduction The dataflow concept Dataflows available - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-3

Storing images and cineloops Storing an image - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-6 Storing a cineloop - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-7 Saving images and cineloops to a standard format - - - - - - - - - - - - - - 11-9 MPEGVue/eVue - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-11 EZ DICOM CD Viewer- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-13

Retrieving and editing archived information Searching for a patient record - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-17 Editing data in the archive - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-20 Deleting archived information- - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-29 Moving examinations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-31

Review images in archive Review the images from a selected examination - - - - - - - - - - - - - - - 11-33 Review images from a selected patient record- - - - - - - - - - - - - - - - - 11-35

Connectivity Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-40 The dataflow concept - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-40 Dataflow selection- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-43 Scanner connectivity configuration - - - - - - - - - - - - - - - - - - - - - - - - - 11-44

Transfer of patient records/examinations Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-57 Transferring patient records/examinations- - - - - - - - - - - - - - - - - - - - 11-58

Disk management Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-65 Configuring the Disk management function - - - - - - - - - - - - - - - - - - - 11-66 Running the Disk management function - - - - - - - - - - - - - - - - - - - - - 11-69

Data Encryption/Decryption Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-73 Data Encryption - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-73 Pause Encryption - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-77 Resume Encryption- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-78

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Change the password - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-80 Change the recovery key- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-82 Unlock with user entered key & recovery key- - - - - - - - - - - - - - - - - - 11-83 Emergency scanning- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-84 Data Decryption - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-84

Data Backup and restore Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-87 Backup procedure- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-88 Restore procedure - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-93

Configuration – Archiving Configuration of the archiving functions- - - - - - - - - - - - - - - - - - - - - - 11-96 TCP/IP configuration - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-97 Dataflow - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-97 Default remote path setting - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-100 XML and MPEG Vue Export configuration- - - - - - - - - - - - - - - - - - - 11-101 Other - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-103

Chapter 12 - Report Introduction Creating a report Working with the report function To open a report - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-4 To choose another report template - - - - - - - - - - - - - - - - - - - - - - - - - - 12-5 To change patient information - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-5 Images in the report - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-5 To print a report - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-5 To store a report - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-6

Structured Findings Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-7 Prerequisite - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-7 Starting Structured Findings- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-8 Using Structured Findings - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-10 Structured Findings configuration - - - - - - - - - - - - - - - - - - - - - - - - - - 12-13

Report designer Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-23 Accessing the Report designer- - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-23 Report designer overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-24 Designing a report template - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-26 Saving the report template- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-38 To exit the Report designer - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-39

Report templates management Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-40 Configuration of the Template selection menu - - - - - - - - - - - - - - - - - 12-41 Export/Import of Report templates - - - - - - - - - - - - - - - - - - - - - - - - - 12-43

Chapter 13 - Probes Probe overview Supported probes - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-2 Probe Applications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-11

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Probe Usage - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-12 Probe orientation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-13 Probe labelling - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-13

Probe Integration Connecting the probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-14 Activating the probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-16 Disconnecting a probe- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-16 Using Intra Cardiac Ultrasound Catheters - - - - - - - - - - - - - - - - - - - - 13-17 Coupling gels - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-21

Care and Maintenance Planned maintenance program - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-22 Inspecting the probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-23 Cleaning and disinfecting probes - - - - - - - - - - - - - - - - - - - - - - - - - - 13-24

Probe safety Electrical hazards - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-30 Mechanical hazards - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-30 Biological hazards- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-31 Special handling instructions - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-32 6Tc-RS,9T-RS/6VT-D Probe Thermal Safety- - - - - - - - - - - - - - - - - - 13-34

Biopsy Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-36 Preparing the Biopsy guide attachment - Convex, Sector and Linear probes - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-37 Displaying the Guide zone - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-41 Biopsy needle path verification- - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-42 Starting the biopsy procedure - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-42 Cleaning, disinfection and disposal- - - - - - - - - - - - - - - - - - - - - - - - - 13-42

Surgery/Intra-operative Use Preparing for Surgery/Intra-operative Procedures - - - - - - - - - - - - - - 13-43

Chapter 14 - Peripherals Introduction Peripherals- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 14-2 CartoSound/SoundStar support - - - - - - - - - - - - - - - - - - - - - - - - - - - - 14-4

Printing Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 14-5 To print an image - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 14-5

Printing configuration Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 14-6 Print tab configuration - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 14-6 Printer setup- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 14-8

Chapter 15 - Maintenance System Data Features/Specifications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 15-2 Clinical Measurement Accuracy - - - - - - - - - - - - - - - - - - - - - - - - - - - 15-10 Clinical Calculation Accuracy - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 15-12

System Care and Maintenance Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 15-13

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Expected Service Life Description - - - - - - - - - - - - - - - - - - - - - - - - - 15-14 Inspecting the system - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 15-14 Cleaning the unit- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 15-15 Cleaning the Cart power box air filter - - - - - - - - - - - - - - - - - - - - - - - 15-19 Cleaning the probes - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 15-22 Peripherals- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 15-22 Prevention of static electricity interference- - - - - - - - - - - - - - - - - - - - 15-22

Quality Assurance Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 15-23 Typical Tests to Perform - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 15-24 Setting up a Record Keeping System - - - - - - - - - - - - - - - - - - - - - - - 15-37 Ultrasound Quality Assurance Checklist - - - - - - - - - - - - - - - - - - - - - 15-38

Supplies/Accessories Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 15-39 Peripherals- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 15-40 Console - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 15-40 AC Power Cord - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 15-41 Gel - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 15-41 Probes- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 15-42

System self-test System malfunction- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 15-43

Software upgrade Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 15-46 Software download and installation- - - - - - - - - - - - - - - - - - - - - - - - - 15-47 Create an Insite permanent user - - - - - - - - - - - - - - - - - - - - - - - - - - 15-50 Save TCP/IP settings - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 15-51

Chapter 16 - Appendix Scan Assist Pro Creator Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-2 Protocol export from Vivid iq and off scanner installation of the Scan Assist Pro Creator - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-3 Starting Scan Assist Pro Creator - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-6 File handling- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-7 Creating new Protocols - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-8 Saving Protocols- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-9 Views - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-10 Step attributes - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-11

Index

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Vivid iq – User Manual 5723892-100 Rev. 05

Chapter 1 Introduction This chapter consists of information concerning indications for use/contraindications, contact information, and how this documentation is organized. The Vivid iq ultrasound unit is a high performance digital ultrasound imaging system with total data management. The system provides image generation in 4D, 2D (B) Mode, Color Doppler, Power Doppler (Angio), M-Mode, Color M-Mode, PW and CW Doppler spectral, Tissue Velocity imaging, advanced Strain and Contrast applications. The fully digital architecture of the Vivid iq unit allows optimal usage of all scanning modes and probe types, throughout the full spectrum of operating frequencies.

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Introduction

Overview

Attention This manual contains necessary and sufficient information to operate the ultrasound unit safely. Read and understand all instructions in the User Manual before attempting to use the ultrasound unit. Keep this manual with the equipment at all time. Periodically review the procedures for operation and safety precautions. NOTE:

The Online Help offers a quick way for the user to access the manual. When there are differences between Online Help and User Manual, please refer to User Manual for the only right version. Disregarding information on safety is considered abnormal use. Not all features, probes, peripherals or products described in this document may be available or cleared for sale in all markets. Please contact your local GE representative to get the latest information. The system is CLASS A and GROUP 1 according to CISPR 11.

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NOTE:

Please note that orders are based on the individually agreed upon specifications and may not contain all features listed in this manual.

NOTE:

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

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Overview Documentation CAUTION

Safety instructions must be reviewed before operating the unit.

Vivid iq documentation consists of various manuals: •

The User Manual, User Guide and Online Help (TRANSLATED) provides information needed by the user to operate the system safely. It describes the basic functions of the system, safety features, operating modes, measurements/calculations, probes, and user care and maintenance.

•

The Advanced Reference Manual (ENGLISH ONLY) contains data tables, such as measurements and calculations, OB, and Acoustic Output.

•

The Release Notes (TRANSLATED) identifies Notes and Workarounds for current Vivid iq system, providing information issues you may encounter while performing scans and offers workarounds for these issues.

•

The Service Manual (ENGLISH ONLY) supplies block diagrams, lists of spare parts, descriptions, adjustment instructions, or similar information which helps qualified technical personnel in repairing those parts of the system which have been defined as repairable.

•

Medical Ultrasound Safety publication from American Institute of Ultrasound in Medicine (AIUM) (ENGLISH ONLY). Provided as ALARA Educational Program, to comply with US FDA Track 3 - Not available in all countries.

The Vivid iq manuals are written for users who are familiar with basic ultrasound principles and techniques. They do not include sonographic training or detailed clinical procedures. NOTE:

The screen graphics in this manual are only for illustrational purposes. Actual screen output may differ.

NOTE:

Probe information displayed on screen examples does not necessarily reflect the probes available on your ultrasound system. Please refer to the Probes chapter for a listing of available probes and features.

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Introduction 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. For example, in the case of human tissue, an echo is created where a signal passes from an adipose tissue (fat) region to a muscular tissue region. The echoes return to the probe where they are converted back into electrical signals. These echo signals are highly amplified and processed by several analog and digital circuits that use filters with many frequency and time response options to transform 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.

Intended use The Vivid iq ultrasound unit is a general-purpose ultrasound system specialized for use in cardiac imaging by a qualified physician for ultrasound evaluation.

Indications for use The Vivid iq is a high-performance compact ultrasound system designed for cardiovascular and shared services applications. The indications of the product will include Fetal, OB, Abdominal, Pediatric, small Organ, Neonatal Cephalic, Adult Cephalic, Cardiac, Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Transcranial, Transrectal, Transvaginal, Transesophageal, Tissue biopsy, Intraoperative, IntraCardiac and Intraluminal.

Frequency of use Daily (Typically 8 hours)

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