Voluson 730 Expert Basic User Manual Rev 6

Revision History

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Revision

Date

Revision 1

July 2005

Revision 2

September 2007

Revision 3

February 2009

Revision 4

February 2010

Revision 5

February 2010

Revision 6

July 2010

Voluson 730 Expert Basic User Manual H48651DT Revision 6

Chapter 1 - General Chapter 2 - Safety Warning labels used in the Basic User Manual - - - - - - - - - - - - - - - - - - 2-3 Important Instructions for Safety- - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-4 Electric installation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-5 Symbols and Labels on the System - - - - - - - - - - - - - - - - - - - - - - - - - - 2-5 Remarks for Safe Use - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-9 Environmental Conditions for Operation - - - - - - - - - - - - - - - - - - - - - - 2-10 Moving or lifting the System - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-11 Instruction for Use- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-11 Biopsy Lines- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-12 ECG preamplifier (MAN) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-12 Cleaning and Maintenance - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-12 Safety Test- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-13 Manufacturer Responsibility- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-14 Service Documents- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-14 Basic Interaction between Ultrasound and Matter - - - - - - - - - - - - - - - 2-14 3D Resolution and Sensitivity- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-22 Disposal- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-23

Chapter 3 - Description of the System Product Description- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-2 Mechanical Design - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-4 System Assembly - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-5 Concept of Operation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-6 Layout of Menus - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-7 Hard keys - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-11 Electronic User Manual (EUM) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-20

Chapter 4 - Starting the System General Remarks - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-2 Safety Warnings - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-2 Power On / Boot Up - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-2 Power Off / Shutdown - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-3 Transducer Connection - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-4 Probe/Program Selection- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-5 Entering Patient Data - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-7 Image Annotation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-30

Chapter 5 - 2D Mode 2D Main Menu - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-2 2D Operation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-4 2D Sub Menu - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-21 Gray Chroma Map - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-25 B-Flow - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-27 XTD-View (Extended View) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-32 Contrast Imaging - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-41

Chapter 6 - M Mode M Main Menu - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-2 M Operation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-3 M Sub Menu- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-7 MCFM Mode (M Color Flow Mode)- - - - - - - - - - - - - - - - - - - - - - - - - - 6-10

Chapter 7 - Spectral Doppler Mode PW Mode (Pulsed Wave Doppler) - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-2 CW Mode (Continuous Wave Doppler) - - - - - - - - - - - - - - - - - - - - - - - 7-13

Chapter 8 - CFM Mode (Color Flow Mode) CFM Main Menu - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-2 CFM Operation- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-3 CFM Sub Menu - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-7 CFM + 2D + Spectral Doppler (Triplex Mode) - - - - - - - - - - - - - - - - - - 8-15

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Chapter 9 - PD Mode (Power-Doppler Mode) PD Main Menu - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-3 PD Operation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-4 PD Sub Menu- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-6 PD + 2D + Spectral Doppler (Triplex Mode) - - - - - - - - - - - - - - - - - - - 9-11 HD-Flow Mode (Bi-directional Angio Mode) - - - - - - - - - - - - - - - - - - - 9-12 HD-Flow Main Menu - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-12 HD-Flow Operation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-13 HD-Flow Sub Menu- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-16 HD-Flow + 2D + Spectral Doppler (Triplex Mode) - - - - - - - - - - - - - - - 9-21

Chapter 10 - TD Mode (Tissue-Doppler Mode) TD Main Menu - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-2 TD Operation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-3 TD Sub Menu - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-5

Chapter 11 - Volume Mode Volume Acquisition with Volume Probes - - - - - - - - - - - - - - - - - - - - - - 11-3 Volume Acquisition: Static 3D Sectional Planes - - - - - - - - - - - - - - - 11-14 Sub Menus- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-47 Volume Acquisition: Static 3D Render - - - - - - - - - - - - - - - - - - - - - - 11-53 Real Time 4D Acquisition - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-78 Volume Cine - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-96 Volume Contrast Imaging: (VCI A-Plane) - - - - - - - - - - - - - - - - - - 11-101 Volume Contrast Imaging (VCI C-Plane) - - - - - - - - - - - - - - - - - - - 11-104 STIC (Spatio-Temporal Image Correlation)- - - - - - - - - - - - - - - - - - 11-108 Real Time 4D Biopsy - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-114 VOCAL II - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-123 VCAD Heart - Volume Computer Aided Display - - - - - - - - - - - - - - - 11-146

Chapter 12 - Utilities Histogram - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-2 Internet - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-5 iLinq - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-6 External Video - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-7 Thermal Indices - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-8 Lock Screen - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-9 Display of Biopsy Guideline - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-13

Chapter 13 - Generic Measurements Basic Operations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-3 2D Mode Measurements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-6 M-Mode Measurements- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-13 D-Mode Measurements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-14 To Change the Measurement Application - - - - - - - - - - - - - - - - - - - - 13-18 To Review the Generic Work Sheet - - - - - - - - - - - - - - - - - - - - - - - - 13-19 Measurement Accuracy of the System - - - - - - - - - - - - - - - - - - - - - - 13-20

Chapter 14 - Calculations and Patient Worksheets (Reports) Basic Calculation Functionality- - - - - - - - - - - - - - - - - - - - - - - - - - - - - 14-3 Basic Patient Worksheet Functions - - - - - - - - - - - - - - - - - - - - - - - - - 14-6 Abdomen Calculations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 14-12 Abdomen - Worksheet- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 14-19 Small Parts Calculations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 14-19 Small Parts - Worksheet - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 14-21 Obstetric Calculations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 14-22 Obstetric - Worksheet - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 14-29 Cardiac Calculations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 14-34 Cardiology - Worksheet - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 14-50 Urology Calculations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 14-50 Urology - Worksheet - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 14-52 Vascular Calculations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 14-53 Vascular - Worksheet - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 14-55

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Voluson 730 Expert Basic User Manual H48651DT Revision 6

Gynecology Calculations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 14-56 Gynecology - Worksheet - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 14-58 Pediatric Calculations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 14-59 Pediatric - Worksheet - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 14-62 Neurology Calculations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 14-62 Neurology - Worksheet - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 14-64 Orthopedics Calculations- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 14-65 Orthopedics - Worksheet - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 14-66

Chapter 15 - Sonoview Selecting Exams- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 15-3 Image Review - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 15-10 Tools - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 15-14

Chapter 16 - Printing / Recording / Saving / Sending Printing - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-2 Saving - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-4

Chapter 17 - System Setup To invoke the Setup Procedure - - - - - - - - - - - - - - - - - - - - - - - - - - - - 17-3 To exit from the Setup Procedure - - - - - - - - - - - - - - - - - - - - - - - - - - - 17-4 The System Setup Desktop Pages - - - - - - - - - - - - - - - - - - - - - - - - - - 17-4

Chapter 18 - Measure Setup To Invoke the Setup Procedure - - - - - - - - - - - - - - - - - - - - - - - - - - - - 18-3 To Exit from the Measure Setup - - - - - - - - - - - - - - - - - - - - - - - - - - - - 18-3 The Measure Setup Pages - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 18-4

Chapter 19 - Biopsy Setup To program a Single Angle Biopsy Line - - - - - - - - - - - - - - - - - - - - - - 19-3 To program a Multi Angle Biopsy Line- - - - - - - - - - - - - - - - - - - - - - - - 19-6 To Program Biopsy Guideline for Rectal Probe - - - - - - - - - - - - - - - - - 19-8

Chapter 20 - Probes and Biopsy Ergonomics - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 20-2 Cable Handling- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 20-2 Probe Orientation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 20-2 Labeling- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 20-3 Applications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 20-5 Features - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 20-7 Settings - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 20-10 Probe Usage - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 20-10 Care and Maintenance - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 20-11 Probe Safety - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 20-12 Special Handling Instructions - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 20-13 Probe Handling and Infection Control - - - - - - - - - - - - - - - - - - - - - - - 20-15 Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 20-22 Biopsy Special Concerns - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 20-27

Chapter 21 - Connections How to Connect Auxiliary Devices Safely - - - - - - - - - - - - - - - - - - - - - 21-2 To Connect Internal and External Accessories- - - - - - - - - - - - - - - - - - 21-3 Connection between Internal I/O and External I/O - - - - - - - - - - - - - - - 21-4 Connection of Peripherals (Overview)- - - - - - - - - - - - - - - - - - - - - - - 21-11 Important Notes: Connecting Auxiliary Equipment - - - - - - - - - - - - - - 21-20

Chapter 22 - MAN ECG preamplifier Description- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 22-2 Handling - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 22-2 Safety Rules to be followed - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 22-4 Care and Maintenance, Repairs - - - - - - - - - - - - - - - - - - - - - - - - - - - - 22-4 ECG Display - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 22-4

Chapter 23 - Technical Data / Information Device Data - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 23-2 Transmitter- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 23-4

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Receiver - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 23-4 Scan Converter - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 23-4 Cine Loop Memory - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 23-5 Display Modes - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 23-5 Signal Processing - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 23-5 Data Entry - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 23-5 User Program Memory - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 23-6 Generic Measurements and Measurements/Calculations - - - - - - - - - - 23-6 Volume Mode (3D/4D)- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 23-8 Spectral-Doppler- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 23-9 Color-Doppler- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 23-10 Tissue-Doppler - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 23-10 Power-Doppler - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 23-11 HD-Flow Mode: - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 23-12 Interfaces- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 23-12 Monitor - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 23-13 Drives - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 23-14 Global Modem - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 23-14 MAN ECG preamplifier - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 23-14

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Voluson 730 Expert Basic User Manual H48651DT Revision 6

Chapter 1 General

Voluson 730 Expert Basic User Manual H48651DT Revision 6

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General

1. General

The Voluson® 730Expert is a professional Diagnostic Ultrasound System which transmits Ultrasound waves into the body tissues and forms images from the information contained within the received echoes. The Voluson® 730Expert is an Active Diagnostic Medical Product belonging to Class IIa according to the MDD 93/42/EWG regulation for use on human patients. The Voluson® 730Expert is developed and produced by the company GE Medical Systems -Kretztechnik GmbH & Co OHG. For more Information, please contact: GE Medical Systems Kretztechnik GmbH & Co OHG Tiefenbach 15 A-4871 Zipf Austria

Telephone: Fax.: Internet:

+43-7682-3800-0 +43-7682-3800-47 http://www.gehealthcare.com

Dear Valuable Customer, We herewith would like to inform you that the American Institute of Ultrasound in Medicine (AIUM) advocates the responsible use of diagnostic ultrasound. The AIUM strongly discourages the non-medical use of ultrasound for psychosocial or entertainment purposes. The use of either two-dimensional (2D) or three-dimensional (3D) ultrasound to only view the fetus, obtain a picture of the fetus or determine the fetal gender without a medical indication is inappropriate and contrary to responsible medical practice. Although the general use of ultrasound for medical diagnosis is considered safe, ultrasound energy has the potential to produce biological effects. Ultrasound bioeffects may result from scanning for a prolonged period, inappropriate use of color or pulsed Doppler ultrasound without a medical indication, or excessive thermal or mechanical index settings. (American Institute of Ultrasound in Medicine: Keepsake Fetal Imaging; 2005) Thus ultrasound should be used in a prudent manner to provide medical benefit to the patient. All references to standards / regulations and their revisions are valid for the time of publication of the user manual.

The screen graphics and illustrations in this manual are for illustrational purposes only and may be different from what you see on the screen or device.

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Voluson 730 Expert Basic User Manual H48651DT Revision 6

Chapter 2 Safety

Voluson 730 Expert Basic User Manual H48651DT Revision 6

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Safety

2. Safety

The Voluson® 730Expert scanner system has been designed for utmost safety for patient and user. Read the following chapters thoroughly before you start working with the machine! The manufacturer guarantees safety and reliability of the system only when all the following cautions and warnings are observed. INDICATIONS FOR USE This system is intended for use by a qualified physician for ultrasound evaluation in the following clinical applications: Fetal/Obstetrics; Abdominal/GYN (including infertility monitoring of follicle development); Pediatric; Small Organ (breast, testes, thyroid, etc.); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Transvaginal and Transrectal. CONTRAINDICATIONS The Voluson® 730Expert system is not intended for ophthalmic use or any use causing the acoustic beam to pass through the eye. THERMAL SAFETY Maintaining a safe thermal environment for the patient has been a design priority at GE Healthcare. Software settings limit the power dissipated for the ultrasound transducer as well as for the motor-drive to values low enough to ensure that operating temperatures stay below 43°C. "

FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN

The use of the system outside the described conditions or intended use, and disregarding safety related information is considered as abnormal use. The manufacturer is not liable for damage caused by abnormal use of the device!

Caution! This machine should be used in compliance with the law. Some jurisdictions restrict certain uses such as gender determination.

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Safety 2.1 Warning labels used in the Basic User Manual NOTE:

Warning labels in the user manual have to be read and observed before proceeding! Notice: Describes important information that has to be read before proceeding.

Caution: Describes general precautions necessary to protect health and equipment.

Bio Hazard: Describes precautions necessary to prevent the risk of disease transmission or infections.

Electric Hazard: Describes precautions necessary to prevent the risk of injury through electric hazards.

Explosion Hazard: Describes precautions necessary to prevent the risk of injury through explosion hazards! Moving Hazard: Describes precautions necessary to prevent the risk of injury through moving or tipping hazards! Mechanical Hazard: Describes precautions necessary to prevent the risk of injury through mechanical hazards!

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Safety 2.2 Important Instructions for Safety This equipment must not be used in oxygen enriched atmosphere or in the presence of inflammable gases (e.g. anesthetic gases)!

The manual refers to probes that can be connected to the device. It might be possible that some probes are NOT available in some countries!! Some features and options are not available in some countries!!

The system must only be connected to a fully intact mains socket with a grounded guard wire via an appropriate mains cable. The ground wire must never be removed or disconnected.

No covers or panels must be removed from the system (high-voltage risk). GE Medical Systems-authorized personal must only perform Service and repairs. Attempting do-it-yourself repairs invalidate warranty are an infringement to regulations and are inadmissible acc. to IEC 60601-1. Under the condition of regular maintenance by the authorized service personal a lifetime of 7 years for the equipment and 5 years for the probes may be expected.

Only accessories explicitly recognized by the system manufacturer GE Medical Systems Kretztechnik GmbH & Co OHG may be used in connection with this ultrasound system.

The footswitch must not be used in operating rooms!

Ultrasound systems are highly sensitive medical instruments that can easily be damaged by improper handling. Use care when handling and protect from damage also when not in use. DO NOT use a damaged or defective ultrasound system. Failure to follow these precautions can result in serious injury and equipment damage.

Not to be used in sterile environment!

There have been reports of severe allergic reactions to medical devices containing latex (natural rubber). Operators are advised to identify latex-sensitive patients and be prepared to treat allergic reactions promptly. Refer to FDA Medical Alert MDA91-1.

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Safety 2.3 Electric installation The system must be exclusively installed in medically used rooms. The equipment conforms with regulations for electrical safety (EN60.601-1 resp. ÖVE-MG/EN60.601-1 and IEC 60601) and safety class IIa according to the MDD 93/42/EWG regulation for use on humans patients. Probes are rated Type BF. Local safety regulations may require an additional connection between the potential equilibrium bolt and the building’s grounding system. Before switching on the first time, the local mains voltage and frequency are to be checked against the values indicated on the Voluson® 730Expert nameplate on the rear panel. Only authorized personnel may perform any changes to the system. Unauthorized modifications may result in hazardous situations. The minimum required house installation must have 16A.

2.4 Symbols and Labels on the System Some symbols used with electrical medical equipment have been accepted as standard by IEC. They serve for marking connections, accessories, and as warnings.

Main power switch ON

Insulated patient application part (Type BF)

Main power switch OFF

Protective earth (ground) connection

System stand-by switch

ECG symbol

Potential equilibrium connection

Defibrillation-proof CF applied part

Probes are rated IPX7, up to 2 cm from patient contact side. Device not rated against ingress of water. Caution, consult accompanying documents. Dangerous electric voltage. Unplug the main plug before opening the system!

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This symbol advises the reader to consult the accompanying documents for important safetyrelated information such as warnings and pre-cautions that cannot be presented on the device itself.

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Safety

This symbol is followed by the manufacturing date of the device in the form YYYY-MM.

Disposal: 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.

This symbol is followed by the serial number of the device.

This symbol is followed by the name and address of the manufacturer of the device.

NRTL Classification Label

GOST-R Label

CE Conformity mark according to Medical Device Directive 93/42/EEC 0123: Identification number of the notified body TÜV SÜD Product Service

This product consists of devices that may contain mercury, which must be recycled or disposed of in accordance with local, state, or country laws. (Within this system, the backlight lamps in the monitor display, contain mercury.)

System passed the quality controls

Indicates that the power cable is hospital grade. Grounding reliability can only be achieved when the equipment is connected to an equivalent receptacle marked “Hospital only” or “Hospital grade”. Applicable depending on local regulatory requirements.

Consult accompanying documents. This symbol advises the reader to consult the accompanying documents. This text indicates the voltages that the device is built for. Please note that either the first voltage range OR the second voltage range is applicable – depending on your country’s voltage. This device uses alternating current. For actual voltage range used for your device see symbol below.

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Green dot on power cable plug

Tipping danger. Do not lean on the system and take special care when moving the system. See ‘Moving or lifting the System’ on page 2-11 for more information.

This indicates the electrical frequency that the device is built for. Please note that either the first frequency OR the second frequency is applicable – depending on your country’s frequency.

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Safety

Indicates that a color signal is available through a connector

Contains marketing information about VolusonClub. For more information please contact your local sales person.

This indicates the maximum rated power consumption of the system.

This symbol indicates that in the United States of America, federal law restricts this device to sale by or on the order of a physician.

Lock probe

Unlock probe

Indicates that the wheels of the system are antistatic.

Use this buttom to turn on the small light beneath the monitor.

Indicates a CW connector. CW is only available if option was bought. (see symbol below)

Indicates a probe connector.

This symbol indicates that the device is equipped with hardware for using CW Doppler.

All labels looking similar to the labels on the left are a marker used during manufacturing and have no meaning relevant to the usage of the device.

Indicates a modem connector.

This label is a marker used during manufacturing and has no meaning relevant to the usage of the device.

Do not put any items on top of the monitor. Danger of breaking.

Indicates a USB connector.

Indicates a network connector.

Indicates a VGA output connector.

Indicates a composite video output connector.

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Safety

10 20

Indicates a fuse.

Indicates a footswitch connector.

Use this button to change brightness and contrast of the monitor.

Use these buttons to navigate in the monitor menu.

Indicates an ECG input connector.

Catalog or model number

Batch or lot number

Indicates a RS232 connector.

These symbols indicate that at least one of the six hazardous substances of the China RoHS Labelling Standard is above the RoHS limitation. The number inside the circle is referred to as the Environmental Friendly Use Period (EFUP). It indicates the number of years that the product, under normal use, will remain harmless to health of humans or the environment. EFUP = 10 for Short Use Products EFUP = 20 for Medium Use Products

Indicates the main power connector of the system. 110, 115, 130, 220, 230 240 VAC (Volts Alternating Current) This device uses alternating current. For actual voltage range used for your device see symbol below.

The voltage shown in this area, is the voltage actually required for the device (country specific). See also symbol above.

This table explains the properties of the different fuses. F1; T16A/250V; 240V, 230V, 220V, 115V, 100V F2; T16A/250V; 240V, 230V, 220V, 115V, 100V F3; T1,6A/250V; 230V F3; T3,2A/250V; 115V F4; T16A/250V; 240V, 230V, 220V, 115V, 100V

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Safety 15 INCH COLOR IMAGE MONITOR MODEL: AY-15CUK RATING: 100V-240V, 160VA, 50/60 Hz Tested to comply with ECC Standards FOR HOME OR OFFICE USE CAUTION: ELECTRIC SHOCK CAUTION: Refer to accompanying documents DO NOT OPEN THIS COVER TRAINED SERVICE PERSON ONLY Complies with DHHS radiation performance standards. 21 CFR Subchapter J. Name and address of manufacturer

2.5 Remarks for Safe Use •

Get acquainted with the transducers and the ultrasound system: read the user manual thoroughly!

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Follow these safety instructions as well as the clinically adopted precautions and measures for hygiene.

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The manufacturer is not liable for damage caused by improper or inexpert use of the device!

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Any ultrasound transducers - irrespective of system and design - are sensitive to shock and shall be treated with care. Pay attention to cracks, which may allow conductive fluids to leak in.

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Authorized personnel shall only perform any type of repair. Never attempt to open a transducer or transducer connector. This leads to a loss of guarantee!

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Avoid kinking, bending or twisting of probe cables and take care to guard them against mechanical stress (e.g., wheels or heels).

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The probes must not be exposed to mechanical shock (e.g., by dropping). Any damage caused in this manner invalidates warranty.

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Have the scanner system and the transducers regularly checked (for faulty cables, housing, etc.) by authorized personnel!

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Damage to transducer or cable may lead to a safety hazard, therefore have them repaired immediately!

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Before plugging in or unplugging a transducer, activate the “FREEZE” mode!

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A specialist acquainted with the handling and use of the system shall perform installation and first switch-on and check-up of the system.

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The user must have read and understood the user manual. The system must only be operated by trained and qualified personnel.

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Safety •

For safety reasons, avoid handling fluids in the vicinity of the system. Fluids leaking into the disk drive can damage the drive. Never remove the storage shelf above the probe connectors; it helps to protect the unit from fluids.

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Do not put your hand under the control console when moving it: Danger of injuries!

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Trolley: never move the unit with blocked wheels, but block the wheels in the proximity of stairs and ramps.

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Place the unit always on horizontal ground and block the front wheels: Danger of tipping over and rolling away.

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In transporting the unit, raise the footrest: Danger of injuries!

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The user manual must always be with the scanner system. It is the user’s duty to ensure this!

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Only probes conforming to type BF requirements may be used with the Voluson® 730Expert.

See the probe’s label. In case of doubt ask authorized service personnel. •

The Voluson® 730Expert system has been tested for EMC and is compliance with EN 55011 group 1 class A (CISPR with amendment) and EN 60601-1-2. The Voluson® 730Expert system is approved for use in a residential district. It is expected that the user has medical experience and is well informed with the user manual.

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Mains power quality should be that of a typical commercial and/or hospital environment. If the user requires continued operation during power mains interruptions, it is recommended that the system be powered from an uninterruptable power source (UPS).

2.6 Environmental Conditions for Operation

Temperature:

18C to 30C resp. 64F to 86F

Humidity:

30% to 80% RH, no condensation

Barometric pressure:

700 to 1060 hPa

Maximum operating altitude:

4000 m

Pollution degree:

2

Overvoltage category:

II

Material group:

IIIb

Do not operate the system in the vicinity of a source of heat, of strong electric or magnetic fields (close to a transformer), or near instruments generating high-frequency signals, such as HF surgery. These can affect the ultrasound images adversely.

In the event the equipment has been brought from a cold environment (stock room, airfreight) into a warm room, allow several hours for temperature balance and passing of condensation humidity before switching on for the first time.

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Safety 2.7 Moving or lifting the System Moving the system on plains

Moving the system on inclines

The Voluson 730 Expert weighs 130 kg or more, depending on installed peripherals, (300 lbs., or more) when ready for use. Care must be used when moving it or replacing its parts. Failure to follow the precautions listed could result in injury, uncontrolled motion and costly damage. ALWAYS: Two people are required when moving on inclines or lifting more than 16 kg (35 lbs). •

Use the handle to move the system. • Be sure the pathway is clear.

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Use slow, careful motions. • Do not let the system strike walls or door frames.

Always place the system on horizontal ground and block the front wheels. The device might tip over or roll away.

Handle carefully. A drop of more than 5 cm may cause mechanical damages.

2.8 Instruction for Use This equipment has been tested and found to comply with the limits for medical devices in IEC 60601-1-2. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. 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 other devices in the vicinity. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to other devices, 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: •

Reorient or relocate the device.

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Increase the separation between the equipment.

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Connect the equipment to an outlet on a circuit different from that to which the other device(s) are connected.

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Consult the manufacturer or field service technician for help.

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Safety 2.9 Biopsy Lines To achieve best possible accuracy of the display of the needle path, the biopsy lines have to be programmed for each transducer. review: To program a Single Angle Biopsy Line (chapter *** 'To program a Single Angle Biopsy Line' on page 3 ***) To program a Multi Angle Biopsy Line (chapter *** 'To program a Multi Angle Biopsy Line' on page 6 ***) •

The biopsy lines must be programmed once by the service personnel or by the user. The procedure must be repeated if probes and/or biopsy guides are exchanged.

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Before performing a biopsy, make sure that the displayed biopsy line coincides with the needle track.

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The needle used for this alignment verification must not be used for the actual procedure. Always use a straight, new and sterile needle for each biopsy procedure.

2.10 ECG preamplifier (MAN) The ECG preamplifier type MAN is an option of the ultrasound scanner unit, used to obtain an ECG signal to mark the systolic and end-diastolic moments in M mode and Doppler evaluations.

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The MAN is not intended for ECG diagnosis. It must not be used for an intra-operative application of the heart.

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Monitor: Not for use as a cardiac monitor.

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Only the patient cable supplied by GE Medical Systems - Kretztechnik, and only recommended electrodes must be used.

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Take care that neither bare parts of one of the three electrodes nor the patient comes into contact with conductive parts (e.g., metal parts of the examination bed, trolley, or similar).

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If the use of a HF surgical unit with simultaneously connected ECG electrodes becomes necessary, a large distance of ECG electrodes from the surgical field and a perfect position of the neutral electrode of the HF surgical unit must be observed (avoiding burning risk).

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If the use of a defibrillator becomes necessary, there must be no ECG adhesive electrodes and no conductive paste between the correct positions of the defibrillator plates (avoiding current bridge; the signal input of the ECG preamplifier is defibrillator-safe).

For further details and information’s please review: MAN ECG preamplifier (chapter *** 'MAN ECG preamplifier' on page 2 ***)

2.11 Cleaning and Maintenance Daily cleaning of the scanner, the probes and the probe holders from coupling gel, mineral oil, etc., is recommended; wet cloth and soap are allowed. Before cleaning the scanner switch it off. Do not use disinfection spray nor gas disinfection. Electric parts must be protected from drip water. Keep the touchpanel screen clean. Dust and grime on the frame can cause irregular function! Check the mains cable, transducer cables, plugs and sockets regularly.

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