Voluson e Basic User Manual Rev 5 SW 8.2X

Revision History

Revision

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Date

Revision 1

September 2008

Revision 2

November 2008

Revision 3

October 2009

Revision 4

August 2010

Revision 5

November 2012

Voluson® e Basic User Manual H48671GE Revision 5

Table of Contents Chapter 1 – General About this User Manual - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-2 Contacting GE Healthcare Ultrasound - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-3

Chapter 2 – Safety Labels and Symbols - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-2 Important Instructions for Safety - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-5 Electric installation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-7 Remarks for Safe Use - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-8 Environmental Conditions for Operation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-9 Instruction for Use - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-9 Biopsy Lines - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-9 Cleaning and Maintenance - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-10 Note for the Administration of “Full Backup” Data - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-11 Manufacturer Responsibility - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-12 Service Documents - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-12 Bioeffects and Safety of Ultrasound Scans - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-13 Disposal - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-15 Guidance and manufacturer´s declaration - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-16 Network disclosure - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-19

Chapter 3 – Getting Started Product Description - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-2 Preparing the unit for use - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-2 Mechanical Design - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-6 System Assembly - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-7 Concept of Operation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-9 Electronic User Manual (EUM) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-17

Chapter 4 – Scanning Operations General Remarks - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-2 Safety Warnings - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-2 Switching On/Off - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-2 Switching off the unit - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-2 Transducer Connection - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-3 Probe/Program Selection - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-4 Entering Patient Data - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-6 Image Annotation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-22

Chapter 5 – 2D Mode 2D Main Menu - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-2 2D Operation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-3 XTD-View - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-16 2D Sub Menu - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-22

Chapter 6 – M Mode M Main Menu - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-2 M Operation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-3 M Sub Menu - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-6 MCFM Mode (M Color Flow Mode) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-8

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Table of Contents Chapter 7 – PW Mode PW Mode (Pulsed Wave Doppler) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-2 PW Main Menu - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-2 PW Operation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-3 Velocity Range (PRF) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-7 Real Time Trace - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-8 Freeze - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-8 PW Cineloop - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-9 PW Sub Menu - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-9 PW + 2D + Color Information (Triplex Mode) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-12

Chapter 8 – CFM Mode (Color Flow Mode) CFM Main Menu - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-2 CFM Operation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-3 CFM Sub Menu - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-6 CFM + 2D + Spectral Doppler (Triplex Mode) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-15

Chapter 9 – PD Mode (Power-Doppler Mode) PD Main Menu - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-2 PD Operation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-3 PD Sub Menu - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-6 PD + 2D + Spectral Doppler (Triplex Mode) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-11 HD Flow - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-12

Chapter 10 – Volume Mode Getting Started - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-2 Acquisition modes - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-5 Visualization modes - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-18 Display modes and special visualisation modes - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-38 Cines - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-48 Volume ultrasound - Theory - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-52

Chapter 11 – Utilities Gray Chroma Map - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-2 Histogram - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-7 Internet - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-9 Display of Biopsy Guideline - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-10 Thermal Indices - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-11 VGA Port - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-11 Screenlock - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-12

Chapter 12 – Generic Measurements Basic Operations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-3 2D Mode Measurements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-5 M-Mode Measurements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-12 D-Mode Measurements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-14 To Change the Measurement Application - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-18 To Review the Generic Worksheet - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-19 Accuracy of measurements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-20

Chapter 13 – Calculations and Patient Worksheets (Reports) Basic Calculation Functionality - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-2 Basic Patient Worksheet Functions - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-5 Abdomen Calculations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-12 Small Parts Calculations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-19

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Table of Contents Obstetric Calculations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-22 Obstetric - Worksheet - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-31 Cardiac Calculations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-37 Urology Calculations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-51 Vascular Calculations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-53 Gynecology Calculations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-56 Pediatric Calculations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-59 Neurology Calculations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-61 Musculoskeletal (MSK) Calculations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-64

Chapter 14 – SonoView Selecting Exams - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 14-2 Image Review - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 14-9 Tools - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 14-14

Chapter 15 – Export & Print Programmable keys - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 15-2 Print - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 15-4 Save - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 15-6 Export - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 15-8

Chapter 16 – System Setup Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-2 General - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-4 User Settings - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-8 P1-P2-P3 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-14 Options - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-14 Service - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-16 Backup - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-16 Network - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-25 System Info - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-38

Chapter 17 – Measure Setup / Biopsy Setup To Invoke the Setup Procedure - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 17-2 To Exit from Measure Setup - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 17-3 The Measure Setup Pages - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 17-3 Biopsy Setup - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 17-20

Chapter 18 – Probes and Biopsies Intended use, contraindications and patient population - - - - - - - - - - - - - - - - - - - - - - - 18-2 Probe Safety - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 18-2 Labeling - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 18-4 Ergonomics - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 18-5 Applications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 18-5 Imaging Modes - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 18-6 Settings - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 18-8 Probe Usage - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 18-8 Special Handling Instructions - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 18-10 Probe Handling and Infection Control - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 18-11 Care and Maintenance - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 18-13 Biopsy Special Concerns - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 18-14 Overview of all probes and biopsies - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 18-16

Chapter 19 – Peripherals and Optional Items How to Connect Auxiliary Devices Safely - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 19-2

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Table of Contents Important Notes: Connecting Auxiliary Equipment - - - - - - - - - - - - - - - - - - - - - - - - - - 19-3 Internal and External connections - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 19-8 Optional Items - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 19-10

Chapter 20 – Technical Data / Information Basic Data - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 20-2 Power supply - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 20-4 Battery - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 20-5 Transmitter - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 20-6 Receiver - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 20-6 Scan Converter - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 20-6 Cine Loop Memory - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 20-7 Display Modes - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 20-7 Signal / Image Processing - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 20-7 Data Entry - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 20-8 User Program Memory - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 20-8 Generic Measurements and Calculations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 20-8 Volume Scan Module (optional) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 20-14 Spectral-Doppler - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 20-15 Color-Doppler - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 20-16 Power-Doppler - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 20-17 HD-Flow mode - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 20-17 External inputs and outputs (Interfaces) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 20-18 Monitor - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 20-18 Drives - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 20-19 Voluson Dock Cart - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 20-19

Chapter 21 – Glossary- Abbreviations

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Chapter 1 General General Information of the Voluson® e

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General The Voluson® e 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® e is an Active Diagnostic Medical Product belonging to Class IIa according to the MDD 93/42/EEC regulation for use on human patients. The Voluson® e is developed and produced by the company GE Healthcare Austria GmbH & Co OG. For more Information, please contact: GE Healthcare Austria GmbH & Co OG Tiefenbach 15 A-4871 Zipf Austria Telephone: +43-7682-3800-0 Fax.: +43-7682-3800-47 Internet: 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.

1.1 About this User Manual

• • • • •

Read and understand all instructions in the Basic User Manual before attempting to use the Voluson® e . This Manual has to be used in connection with the Voluson® e . Keep this User Manual with the equipment at all times. All information contained in the Voluson® e User Manual is relevant. Periodically review the procedures for operation and safety precautions.

New company name: GE Healthcare Austria GmbH & CO OG Please be advised that the new company name will replace the old company name wherever used in the manual. The screen graphics and illustrations in this manual are for illustrative purposes only and may be different from what is displayed on the screen or device.

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

1.2 Contacting GE Healthcare Ultrasound For additional information or assistance, please contact your local distributor or the appropriate support resource listed on the following pages: INTERNET

http://www.gehealthcare.com http://www.gehealthcare.com/usen/ultrasound/products/ probe_care.html

Clinical Questions

For information in the United States, Canada, Mexico and parts of the Caribbean, call the Customer Answer Center Phone: (1) 800-682-5327 or (1) 262-524-5698 In other locations, contact your local Applications, Sales or Service Representative.

Service Questions

For service in the United States, call GE CARES Phone: (1) 800-437-1171 For service for compact products in the United States, call Phone: (1) 877-800-6776 In other locations, contact your local Service Representative.

Information Request

To request the latest GE Accessories catalog or equipment brochures in the United States, call the Response Center Phone: (1) 800-643-6439 In other locations, contact your local Applications, Sales or Service Representative.

Placing an Order

To order accessories, supplies or service parts in the United States, call the GE Healthcare Technologies Contact Center Phone: (1) 800-558-5102 In other locations, contact your local Applications, Sales or Service Representative.

ARGENTINA

GEME S.A. Miranda 5237 Buenos Aires - 1407 Phone: (1) 639-1619 Fax: (1) 567-2678

ASIA PACIFIC JAPAN

GE Healthcare Asia Pacific 4-7-127, Asahigaoka Hino-shi, Tokyo 191-8503 Japan Tel: +81 42 585 5111

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General

AUSTRALIA NEW ZEALAND

GE Healthcare Australia & New Zealand Building 4B, 21 South St Rydalmere NSW 2116 Australia Tel: 1300 722 229 8 Tangihua Street Auckland 1010 New Zealand Tel: 0800 434 325

AUSTRIA

General Electric Austria GmbH Filiale GE Healthcare Technologies EURO PLAZA, Gebäude E Wienerbergstrasse 41 A-1120 Vienna Phone: (+43) 1 97272 0 Fax: (+43) 1 97272 2222

BELGIUM &

GE Medical Systems Ultrasound Eagle Building

LUXENMBURG

Kouterveldstraat 20 1831 DIEGEM Phone: (+32) 2 719 7204 Fax: (+32) 2 719 7205

BRAZIL

Equipamentos Médicos Ltda Av. Das Nações Unida, 8501 3º andar parte - Pinheiros São Paulo SP - CEP: 05425-070 C.N.P.J.: 02.022.569/0001-83 Phone: 3067-8493 Fax: (011) 3067-8280

CANADA

GE Healthcare Ultrasound Service Engineering 9900 Innovation Drive Wauwatosa, WI 53226 Phone: (1) 800 668-0732 Customer Answer Center

CHINA

Phone: (1) 262-524-5698

GE Healthcare - Asia No. 1, Yongchang North Road Beijing Economic & Technology Development Area Beijing 100176, China Phone: (8610) 5806 8888 Fax: (8610) 6787 1162

CZECH REPUBLIC

GE Medical Systems Ultrasound Vyskocilova 1422/1a 140 28 Praha

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DENMARK

GE Medical Systems Ultrasound Park Alle 295 2605 Brøndby Phone: (+45) 43 295 400 Fax: (+45) 43 295 399

ESTONIA &

GE Medical Systems

FINLAND

Kuortaneenkatu 2, 000510 Helsinki P.O.Box 330, 00031 GE Finland Phone: (+358) 10 39 48 220 Fax: (+358) 10 39 48 221

FRANCE

GE Medical Systems Ultrasound and Primary Care Diagnostics F-78457 Velizy Fax: (+33) 13 44 95 202 General Imaging: Phone: (+33) 13 449 52 43 Cardiology: Phone: (+33) 13 449 52 31

GERMANY

GE Healthcare GmbH Beethovenstrasse 239 42655 Solingen Phone: (+49) 212-28 02-0 Fax: (+49) 212-28 02 28

GREECE

GE Healthcare 8-10 Sorou Str. Marousi Athens 15125 Hellas Phone: (+30) 210 8930600 Fax: (+30) 210 9625931

HUNGARY

GE Hungary Zrt. Ultrasound Division Akron u. 2 Budaors 2040 Hungary Phone: (+36) 23 410 314 Fax: (+36) 23 410 390

INDIA

Wipro GE Healthcare Pvt Ltd No. 4, Kadugodi Industrial Area Bangalore, 560067 Phone: +(91) 1-800-425-8025

ITALY

GE Medical Systems Italia spa Via Galeno, 36 20126 Milano Phone: (+39) 02 2600 1111 Fax: (+39) 02 2600 1599

KOREA

Seoul, Korea Phone: (+82) 2 6201 3114

LUXEMBOURG

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Phone: 0800 2603 toll free

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MEXICO

GE Sistemas Medicos de Mexico S.A. de C.V. Rio Lerma #302, 1º y 2º Pisos Colonia Cuauhtemoc 06500-Mexico, D.F. Phone: (5) 228-9600 Fax: (5) 211-4631

NETHERLANDS

GE Healthcare De Wel 18 B, 3871 MV Hoevelaken PO Box 22, 3870 CA Hoevelaken Phone: (+31) 33 254 1290 Fax: (+31) 33 254 1292

NORTHERN IRELAND

GE Healthcare Victoria Business Park 9, Westbank Road, Belfast BT3 9JL Phone: (+44) 28 90229900

NORWAY

GE Medical Systems Ultrasound Tåsenveien 71, 0873 Oslo Phone: (+47) 2202 0800 Strandpromenaden 45, P.O. Box 141, 3191 Horten Phone: (+47) 33 02 11 16

POLAND

GE Medical Systems Polska Sp. z o.o., ul. Wołoska 9 02-583 Warszawa, Poland Phone: (+48) 22 330 83 00 Fax: (+48) 22 330 83 83

PORTUGAL

General Electric Portuguesa SA. Avenida do Forte, n° 4 Fraccao F, 2795-502 Carnaxide Phone: (+351) 21 425 1309 Fax: (+351) 21 425 1343

REPUBLIC OF IRELAND

GE Healthcare Unit F4, Centrepoint Business Park Oak Drive, Dublin 22 Phone: (+353) 1 4605500

RUSSIA

GE Healthcare Krasnopresnenskaya nab., 18, bld A, 10th floor 123317 Moscow, Russia Phone: (+7) 4957 396931 Fax:(+7) 4957 396932

SINGAPORE

GE Healthcare Singapure 1 Maritime Square #13-012 HarbourFront Centre Singapore 099253 Tel: +65 6291 8528

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SPAIN

GE Healthcare Espana C/ Gobelas 35-37 28023 Madrid Phone: (+34) 91 663 2500 Fax: (+34) 91 663 2501

SWEDEN

GE Medical Systems Ultrasound PO Box 314 17175 Stockholm Phone: (+46) 8 559 50010

SWITZERLAND

GE Medical Systems Ab Europastrasse 31 8152 Glattbrugg Phone: (+41) 1 809 92 92 Fax: (+41) 1 809 92 22

TURKEY

GE Healthcare Türkiye Istanbul Office TEL: +90 212 398 07 00 Levent Ofis FAKS: +90 212 284 67 00 Esentepe Mah. Harman Sok. No:8 Sisli-Istanbul Ankara Office TEL: +90 312 289 77 00 Mustafa Kemal Mah. FAKS: +90 312 289 78 02 2158.Sok No:9 Çankaya-Ankara

United Arab Emirates GE Healthcare Holding (U.A.E.) Dubai Internet City, Building No. 18 P.O. Box #11549, Dubai U.A.E. Phone: +971 4 4296161 Phone: +971 4 4296101 Fax: +971 4 4296201 UNITED KINGDOM

GE Medical Systems Ultrasound 71 Great North Road Hatfield, Hertfordshire, AL9 5EN Phone: (+44) 1707 263570 Fax: (+44) 1707 260065

USA

GE Healthcare Ultrasound Service Engineering 9900 Innovation Drive Wauwatosa, WI 53226 Phone: (1) 800-437-1171 Fax: (1) 414-721-3865

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Chapter 2 Safety Describes the safe handling of the Voluson® e and the warning signs

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Safety

The hand-held (portable) Voluson® e scanner system has been designed 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. INTENDED USE This system is intended for use by a qualified physician for ultrasound evaluation in the following clinical applications: Image Acquisition for diagnostic purposes including measurements on acquired image. Clinical applications:

• Fetal/Obstetrics • Abdominal/GYN (including infertility monitoring of follicle development)

• • Small Organ (breast, testes, thyroid, Pediatric etc.)

• Cardiac (fetal cardio) • Peripheral Vascular • Musculo-skeletal Conventional and

Patient population:

Operator profile:

• Age: all ages (incl.

• Qualified and trained

• Location: worldwide • Sex: male and female • Weight: all weight

• The operator must have

embryos and fetuses)

categories

physicians or sonographers with at least basic ultrasound knowledge. read and understood the user manual.

Superficial

• Transvaginal and Transrectal CONTRAINDICATIONS The Voluson® e system is not intended for:

• •

ophthalmic use or any use causing the acoustic beam to pass through the eye. intra-operative use

ESSENTIAL PERFORMANCE OF THE ULTRASOUND SYSTEM

• • • •

Acquisition of ultrasound images Display of ultrasound images on main display Measurement on ultrasound images System must remain in a safe condition acc. IEC60601

2.1 Labels and Symbols 2.1.1 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.

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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! Mechanical Hazard: Describes precautions necessary to prevent the risk of injury through mechanical hazards!

Laser radiation

2.1.2 Description of symbols and labels Some symbols used with electrical medical equipment have been accepted as standard by IEC. They serve for marking connections, accessories, and as warnings. System stand-by switch

Insulated patient application part (Type BF)

Protection against the effects of immersion (probes)

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

Caution, consult accompanying documents. This symbol advises the user to consult the accompanying documents for important safety-related information such as warnings and pre-cautions that cannot be presented on the device itself.

Consult accompanying documents. This symbol advises the user to consult the accompanying documents.

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

This symbol is followed by the manufacturing date in the format YYYYMM.

Pictogram on Probe Care Card:

Pictogram on Probe Care Card:

Use care when handling ultrasound probes and protect the probe head from damage.

Do not immerse the probe into any liquid beyond the level specified for that probe. Refer to the user manual of the ultrasound system.

Pictogram on Probe Care Card:

Pictogram on Probe Care Card:

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

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

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

Batch or lot number

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Safety

Catalog or model number.

Disposal: 'Disposal' on page 2-15

NRTL Classification Label (old and new version)

GOST-R Label

CE Conformity mark according to Medical Device Directive 93/42/EEC

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.)

0123: Identification number of the notified body TÜV SÜD Product Service

This symbol indicates PSE rating required for Japanese market

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Green dot on power cable plug

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.

This symbol indicates the voltage that the device is built for. This device requires direct current.

This indicates the maximum rated power consumption of the system.

This label represents the license of the operating system used on this device.

Indicates a USB connector.

Indicates a monitor connector

Indicates a network connector.

Indicates the battery status LED. 'LED Status Table' on page 3-6

Indicates the power status LED. 'LED Status Table' on page 3-6

This symbol indicates the connector for a theft protection lock.

Indicates a docking connector for connecting the system to the Voluson Station.

Indicates the locking mechanism for the probe connector.

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

This symbol indicates that the power supply has passed the quality check (optional)

Do not reuse! This symbol indicates that the item/device is for single use only.

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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.

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.

EFUP = 10 for Short Use Products EFUP = 10 for Short Use Products Product was refurbished / remanufactured by GE Healthcare Austria GmbH & Co OG

2.2 Important Instructions for Safety 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. Caution! This machine should be used in compliance with the law. Some jurisdictions restrict certain uses such as gender determination. Caution: The quality of the image used for diagnosis is essential:

•

•

Changing the display settings can affect the image quality and compromise the diagnostic quality. The user is responsible to use adequate display settings for achieving appropriate image quality. If in doubt, only the image as displayed on the Voluson® ultrasound system with default display settings is to be used for diagnostic purposes. Do not diagnose based on print-outs.

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. Caution: Features that facilitate measurements (e.g. SonoAVC follicle, Vocal, SonoNT,...) must be used with extreme care. Such measurements are a suggestion of the system. If in doubt verify the measurement results with manual measurement methods. The user is responsible for the diagnostic interpretation of measurements.

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Safety

Caution: The system provides calculations (e.g estimated fetal weight) and charts based on published scientific literature. The selection of the appropriate chart and clinical interpretation of calculations and charts are the sole responsibility of the user. The user must consider contraindications for the use of a calculation or chart as described in the scientific literature. The diagnosis, decision for further examinations and medical treatment must be performed by qualified personnel following good clinical practice. This equipment must not be used in oxygen enriched atmosphere or in the presence of inflammable gases (e.g. anesthetic gases) because of explosion hazard! 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. 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. No covers or panels must be removed from the system (high-voltage risk). Only GE Healthcare authorized personnel must perform service and repairs. Attempting do-it-yourself repairs invalidate warranty are an infringement to regulations and are inadmissible acc. to IEC 60601-1. For expected lifetime of equipment and probes see Service Manual. 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.

Any power supply of additional equipment has to be confirm with IEC60601-1.

Do not touch the patient and the Signal Input/Output lines at the same time.

Disconnect mains from power supply and remove battery pack to make device electroless.

The use of a protective cover is required when performing surgical procedures to prevent contamination and transfer of infectious material to patients and health care workers when operating the system.

This equipment is not to be used during transportation (e.g. ambulance cars, aircrafts).

Use for diagnostic purposes only!

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