Voluson i Basic User Manual Rev 4

Revision History

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Revision

Date

Revision 1

September 2008

Revision 2

November 2008

Revision 3

October 2009

Revision 4

August 2010

Voluson® i Basic User Manual H48671HD Revision 4

Table of Contents Chapter 1 - General General

Chapter 2 - Safety Safety Labels and Symbols - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-2 Important Instructions for Safety - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-5 Electric installation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-8 Remarks for Safe Use- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-8 Environmental Conditions for Operation - - - - - - - - - - - - - - - - - - - - - - - - - 2-9 Instruction for Use - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-9 Biopsy Lines- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-10 Cleaning and Maintenance - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-10 Safety Test - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-11 Manufacturer Responsibility - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-11 Service Documents- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-12 Basic Interaction between Ultrasound and Matter - - - - - - - - - - - - - - - - - 2-13 3D Resolution and Sensitivity - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-19 Disposal - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-21

Chapter 3 - Getting Started Getting Started

Product Description - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-2 Preparing the unit for use - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-3 Mechanical Design - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-7 System Assembly - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-9 Concept of Operation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-11 Electronic User Manual (EUM)- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-20

Chapter 4 - Basic Scanning Operations Scanning Operations

General Remarks - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-2 Safety Warnings- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-2 Switching On/Off - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-2 Switching off the unit - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-2 Transducer Connection - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-4 Probe/Program Selection - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-5 Entering Patient Data- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-6 Image Annotation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-24

Chapter 5 - 2D Mode 2D Mode

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

Chapter 6 - M Mode -Motion Mode M Mode

M Main Menu - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-3 M Operation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-3 M Sub Menu - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-7 MCFM Mode (M Color Flow Mode) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-9

Chapter 7 - PW Mode - Pulsed Wave Mode PW Mode

PW Mode (Pulsed Wave Doppler) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-3 PW Main Menu- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-3 PW Operation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-4

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Table of Contents PW Sub Menu - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-10 PW + 2D + Color Information (Triplex Mode)- - - - - - - - - - - - - - - - - - - - - - 7-12

Chapter 8 - Color Flow Mode

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

Chapter 9 - Power Doppler-Mode PD Mode (Power-Doppler Mode)

PD Main Menu - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-3 PD Operation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-3 PD Sub Menu - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-7 PD + 2D + Spectral Doppler (Triplex Mode) - - - - - - - - - - - - - - - - - - - - - - - 9-11 HD Flow - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-12

Chapter 10 - Volume Mode Volume Mode

Getting Started - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-2 Acquisition modes - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-6 Visualization modes - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-32 Display modes and special visualisation modes - - - - - - - - - - - - - - - - - - - 10-70 Cines - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-81 Volume ultrasound - Theory- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-86

Chapter 11 - Utilities Utilities

Gray Chroma Map - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-3 Histogram - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-7 Internet- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-9 Display of Biopsy Guideline - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-9 Thermal Indices - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-10 Activate VGA Port - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-11 Screenlock- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-11

Chapter 12 - Generic Measurements Generic Measurements

Basic Operations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-3 2D Mode Measurements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-5 M-Mode Measurements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-11 D-Mode Measurements- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-13 To Change the Measurement Application - - - - - - - - - - - - - - - - - - - - - - - 12-17 To Review the Generic Worksheet - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-18 Measurement Accuracy of the System - - - - - - - - - - - - - - - - - - - - - - - - - 12-19

Chapter 13 - Calculations and Patient Worksheets Calculations and Patient Worksheets (Reports)

Basic Calculation Functionality- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-3 Basic Patient Worksheet Functions- - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-5 Abdomen Calculations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-12 Abdomen - Worksheet - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-19 Small Parts Calculations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-20 Small Parts - Worksheet - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-22 Obstetric Calculations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-23 Obstetric - Worksheet - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-33 Cardiac Calculations- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-40 Cardiology - Worksheet- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-55 Urology Calculations- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-56 Urology - Worksheet- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-58 Vascular Calculations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-59 Vascular - Worksheet - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-60 Gynecology Calculations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-61

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Gynecology - Worksheet - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-63 Pediatric Calculations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-64 Pediatric - Worksheet - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-66 Neurology Calculations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-67 Neurology - Worksheet - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-68

Chapter 14 - SonoView SonoView

Selecting Exams- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 14-3 Image Review - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 14-10 Tools- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 14-14

Chapter 15 - Export & Print Export & Print

Programmable keys - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Print - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Save - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Export- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Chapter 16 - System Setup

15-2 15-4 15-6 15-9

System Setup Introduction- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-2 General - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-4 User Settings - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-8 P1-P2-P3 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-15 Options - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-16 Service - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-18 Backup - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-18 Network - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-27 System Info - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-40

Chapter 17 - Measure Setup

Measure Setup / Biopsy Setup To Invoke the Setup Procedure- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 17-3 To Exit from Measure Setup - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 17-4 The Measure Setup Pages - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 17-4 Biopsy Setup - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 17-22

Chapter 18 - Probes and Biopsy Probes and Biopsy

Probe Safety - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 18-2 Introduction- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 18-3 Applications- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 18-8 Imaging Modes - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 18-9 Settings - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 18-10 Probe Usage - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 18-11 Special Handling Instructions- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 18-13 Probe Handling and Infection Control - - - - - - - - - - - - - - - - - - - - - - - - - - 18-14 Care and Maintenance - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 18-21 Biopsy Special Concerns - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 18-22

Chapter 19 - Peripherals and Optional Items Peripherals and Optional Items

How to Connect Auxiliary Devices Safely - - - - - - - - - - - - - - - - - - - - - - - 19-2 To Connect External Accessories - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 19-2 Internal and External connections - - - - - - - - - - - - - - - - - - - - - - - - - - - - 19-3 Connection of Peripherals (Overview) - - - - - - - - - - - - - - - - - - - - - - - - - - 19-5 Optional Items - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 19-11

Chapter 20 - Technical Data

Technical Data / Information Basic Data- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Power supply - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Battery - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Transmitter - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

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20-3 20-5 20-6 20-7

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Table of Contents Receiver - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 20-8 Scan Converter - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 20-9 Cine Loop Memory - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 20-9 Display Modes - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 20-10 Signal / Image Processing - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 20-10 Data Entry - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 20-11 User Program Memory - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 20-11 Generic Measurements and Calculations - - - - - - - - - - - - - - - - - - - - - - - 20-12 Volume Scan Module (optional) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 20-17 Spectral-Doppler - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 20-19 Color-Doppler - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 20-19 Power-Doppler- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 20-20 HD-Flow mode- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 20-21 External inputs and outputs (Interfaces) - - - - - - - - - - - - - - - - - - - - - - - - 20-22 Monitor - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 20-22 Drives - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 20-23 Voluson Dock Cart - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 20-23 Guidance and manufacturer´s declaration - - - - - - - - - - - - - - - - - - - - - - 20-24

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Chapter 1 General General Information of the Voluson® i

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General

1. General

The Voluson® i 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® i 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® i 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: +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

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

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Safety

2. Safety

The hand-held (portable) Voluson® i 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. INDICATIONS FOR USE This system is intended for use by a qualified physician or sonographer for ultrasound evaluation in the following clinical applications:

patient population:

• Fetal/Obstetrics • Abdominal/GYN (including infertility monitoring of follicle development) • Pediatric • Small Organ (breast, testes, thyroid, etc.) • Cardiac (fetal cardio) • Peripheral Vascular • Musculo-skeletal Conventional and Superficial • Transvaginal and Transrectal

• Age: all ages (encl. embryos and fetuses) • Location: worldwide • Sex: male and female • Weight: all weight categories

Intended use: Image Acquisition for diagnostic purposes encl. measurements on acquired image. Use for diagnostic purposes only! CONTRAINDICATIONS The Voluson® i system is not intended for ophthalmic use or any use causing the acoustic beam to pass through the eye.

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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Safety 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! Orientation: Lists all major sections in the chapters, for orientation purposes.

2.1.2 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.

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 YYYY-MM.

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

Batch or lot number

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Catalog or model number.

Disposal: See ‘Disposal’ on page 2-21 for more information.

System passed the quality control (optional)

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.

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.)

This symbol indicates PSE rating required for Japanese market

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.

Green dot on power cable plug

This text 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. See ‘LED Status Table’ on page 3-8 for more information.

Indicates the power status LED. See ‘LED Status Table’ on page 3-8 for more information.

This symbol indicates the connector for a theft protection lock.

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

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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)

10 20

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

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.

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. 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.

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!

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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 Medical Systems-authorized personnel must perform Service and repairs. Attempting doit-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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Misinterpretation of the ultrasound images can lead to a false diagnosis.

Image quality and penetration depth may be adversely affected when equipment is used on adipose patients.

Using volume, image or video compression methods at higher rates reduces image quality, which can lead to a false diagnosis.

Bright light could impact readability of screen.

Before installing new peripheral devices or other optional items to the Voluson® i, please check the device on cracks or damages. If a device is damaged or has a crack, please contact your local Service or OnlineCenter.

Do not drop the Voluson® i. This may cause major damage to the device.

Do not cover the ventilation holes of the Voluson® i.

Do not use with a defibrillator. This equipment does not have a defibrillator approved applied part.

Only use with provided power supply. See ‘Power supply’ on page 20-5 for more information.

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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. Before switching on the first time, the local mains voltage and frequency are to be checked against the values indicated on the Voluson® i nameplate on the rear panel. Only authorized personnel must perform any change to the system. Unauthorized modifications may result in hazardous situations. The minimum required house installation must have 10A.

2.4 Remarks for Safe Use •

Operator profile: Qualified physicians and professional sonographers with at least basic ultrasound knowledge.

•

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

•

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

•

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

•

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.

•

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!

•

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

•

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

•

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

•

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

•

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

•

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

•

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

•

For safety reasons, avoid handling fluids in the vicinity of the system. Fluids leaking into the user interface can damage the Voluson® i.

•

Place the unit always on horizontal ground.

•

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

•

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

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

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The Voluson® i system has been tested for EMC and is compliant with EN 55011 group 1 class A (CISPR 11 amendment 1) and EN 60601-1-2.

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Safety The Voluson® i 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. •

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).

2.5 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:

Europe: maximum 2000m according to IEC606011:2005 3rd edition Rest of the world: maximum 4000m according to IEC60601-1:1988+A1:1991+A2:1995 2nd edition

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.

2.6 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.

•

Increase the separation between the equipment.

•

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

•

Consult the manufacturer or field service technician for help.

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Safety 2.7 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 *** 'To program a Single Angle Biopsy Line' on page 23 *** To program a Multi Angle Biopsy Line *** 'To program a Multi Angle Biopsy Line' on page 26 *** •

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.

•

Before performing a biopsy, make sure that the displayed biopsy line coincides with the needle track (check in a bowl filled with approx. 47C warm water).

•

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.

2.8 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. Dust and grime on the frame can cause irregular function! Check the mains cable, transducer cables, plugs and sockets regularly. Have the system checked and serviced in regular intervals (once per year) by authorized service personnel. In case of total failure first check if mains voltage is present. Mentioning any observations or failure symptoms to the service engineers is helpful.

2.8.1 Note for the Administration of “Full Backup” Data All settings and patient data created since last full backup are NOT backed-up! It is highly recommended to create a full backup of settings and patient data regularly. When the Full Backup is stored on a network drive, it may be desirable to move the data (e.g., for backup or maintenance). For further details review: Save Full Backup *** 'Save Full Backup' on page 22 *** To Backup the Exams *** 'To Backup the Exams' on page 7 *** The directory structure of the full backup data is as follows:

Every “Full Backup” resides in a subfolder of the main “fullbackup”-folder found at the root of the drive. For example: Z:fullbackup. The subfolders have the names fbX where X is a number (e.g., Z:fullbackupfb1). The data resides within a directory structure within these subfolders. It is possible to move the fbX subfolders, even leaving gaps in the numeration sequence. However, NO change MUST be made to the contents of the fbX folders itself, otherwise the backup data cannot be restored!

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Housing, connection, operating elements, display facilities, labels, accessories, user manual.

b)

Functional test:

Checking of functions (acc. to user manual), check also modular combinations and common operability of system and accessories.

c)

Electric test:

Checking of the electric safety of system combinations acc. to VDE 0751 or respective national regulations.

a)

For safety reasons, avoid handling fluids in the vicinity of the system.

Item

Safety Test

Notes

Console Leakage Current Checks

Annually

Also after corrective maintenance or as required by your facilities QA program.

Peripheral Leakage Current Checks

Annually

Also after corrective maintenance or as required by your facilities QA program.

Surface Probe Leakage Current Checks

Annually

Also after corrective maintenance or as required by your facilities QA program.

Endocavity Probe Leakage Current Checks

Annually

2.10 Manufacturer Responsibility The manufacturer, assembler, importer or installer considers himself/herself responsible regarding safety, reliability and performance of the instrument under the following conditions: •

when assembling the system, when adding options, when new settings or modifications or repairs were performed by personnel authorized by him/her,

•

also that the local electric installation complies to the national regulations, and that the equipment is only used according to the User Manual.

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Safety 2.11 Service Documents The Service Manual supplies block diagrams, lists of spare parts, descriptions, adjustment instructions or similar information which help adequately qualified technical personnel in repairing those parts of the instrument which have been defined repairable by the manufacturer. If requested the manufacturer will supply the service manual to authorized technical personnel.

2.11.1 Service Software – Remote Access By using the remote access feature, a GE field engineer can access the ultrasound system via a modem connection. The field engineers are required to announce every remote connection to a system previously by calling the affected site. Disruptive Mode: If the field engineer requires unrestricted access to the ultrasound system the field engineer requests for disruptive mode on the system. A message appears on the screen asking for permission to switch to disruptive mode: GE Service is requesting permission to diagnose the system remotely. Normal system operations might be disturbed during this period. Click on YES to allow GE Service to continue system diagnostics. If disruptive mode is accepted, work on the system can be disturbed severely. Therefore, it is not allowed to perform an exam or make a diagnosis using the ultrasound system while being in disruptive mode. NOTE:

A remote connection can affect the system’s performance (e.g., in 3D/4D or Doppler mode). Therefore, it is recommended to cease work on the system as soon as the field engineer contacts the site and announces the remote connection. Network Security: The remote access features enables, after checkout has been performed, network services like ftp or telnet on the ultrasound system. Therefore, it is advisable to restrict network access to system for unauthorized personnel. It is strongly recommended to use a firewall to restrict network access from and to an ultrasound system with the remote access feature installed. Other precautions like a secure network segment are encouraged. For Ethernet connection, a separation device has to be used.

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