GE Voluson i User manual

GE Healthcare

Voluson® i

Basic User Manual

English (English)

GE imagination at work

H48671HD

Revision 5

SW 8.2.X

2012 © by General Electric

Revision History

Revision	Date
Revision 1	September 2008
Revision 2	November 2008
Revision 3	October 2009
Revision 4	August 2010
Revision 5	November 2012

	Voluson® i Basic User Manual
i-ii	H48671HD 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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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 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-28 Display modes and special visualisation modes - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-65 Cines - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-76 Volume ultrasound - Theory - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-80

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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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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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 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 20-16 Color-Doppler - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 20-16

Power-Doppler - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 20-17

HD-Flow mode - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 20-18 External inputs and outputs (Interfaces) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 20-18 Monitor - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 20-19 Drives - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 20-19 Voluson Dock Cart - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 20-19

Chapter 21 – GlossaryAbbreviations

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Chapter 1

General

General Information of the Voluson® i

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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/EEC regulation for use on human patients.

The Voluson® i 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: [phone]

Fax.: [phone]

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.

1.1About this User Manual

•Read and understand all instructions in the Basic User Manual before attempting to use the Voluson® i .

•This Manual has to be used in connection with the Voluson® i .

•Keep this User Manual with the equipment at all times.

•All information contained in the Voluson® i 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: [phone] 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: [phone]
	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: [phone]
	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: [phone]
	In other locations, contact your local Applications, Sales or Service
	Representative.
ARGENTINA	GEME S.A.
	Miranda 5237
	Buenos Aires - 1407
	Phone: [phone]
	Fax: [phone]
ASIA PACIFIC	GE Healthcare Asia Pacific
JAPAN	4-7-127, Asahigaoka
	Hino-shi, Tokyo
	191-8503 Japan
	Tel: [phone]

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AUSTRALIA	GE Healthcare Australia & New Zealand
NEW ZEALAND	Building 4B, 21 South St
	Rydalmere NSW 2116
	Australia
	Tel: [phone]
	8 Tangihua Street
	Auckland 1010
	New Zealand
	Tel: [phone]
AUSTRIA	General Electric Austria GmbH Filiale GE Healthcare Technologies
	EURO PLAZA, Gebäude E
	Wienerbergstrasse 41
	A-1120 Vienna
	Phone: [phone]
	Fax: [phone]
BELGIUM &	GE Medical Systems Ultrasound Eagle Building
LUXENMBURG	Kouterveldstraat 20
	1831 DIEGEM
	Phone: [phone]
	Fax: [phone]
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: [phone]
	Fax: [phone]
CANADA	GE Healthcare
	Ultrasound Service Engineering
	9900 Innovation Drive
	Wauwatosa, WI 53226
	Phone: [phone]
	Customer Answer Center Phone: [phone]
CHINA	GE Healthcare - Asia
	No. 1, Yongchang North Road
	Beijing Economic & Technology Development Area
	Beijing 100176, China
	Phone: [phone]
	Fax: [phone]
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: [phone]
	Fax: [phone]
ESTONIA &	GE Medical Systems
FINLAND	Kuortaneenkatu 2, 000510 Helsinki
	P.O.Box 330, 00031 GE Finland
	Phone: [phone]
	Fax: [phone]
FRANCE	GE Medical Systems Ultrasound and Primary Care Diagnostics
	F-78457 Velizy
	Fax: [phone]
	General Imaging: Phone: [phone]
	Cardiology: Phone: [phone]
GERMANY	GE Healthcare GmbH
	Beethovenstrasse 239
	42655 Solingen
	Phone: [phone]
	Fax: [phone]
GREECE	GE Healthcare
	8-10 Sorou Str. Marousi
	Athens 15125 Hellas
	Phone: [phone]
	Fax: [phone]
HUNGARY	GE Hungary Zrt. Ultrasound Division
	Akron u. 2
	Budaors 2040 Hungary
	Phone: [phone]
	Fax: [phone]
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: [phone]
	Fax: [phone]
KOREA	Seoul, Korea
	Phone: [phone]
LUXEMBOURG	Phone: [phone] 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: [phone]
	Fax: [phone]
NETHERLANDS	GE Healthcare
	De Wel 18 B, 3871 MV Hoevelaken
	PO Box 22, 3870 CA Hoevelaken
	Phone: [phone]
	Fax: [phone]
NORTHERN	GE Healthcare
IRELAND	Victoria Business Park
	9, Westbank Road, Belfast BT3 9JL
	Phone: [phone]
NORWAY	GE Medical Systems Ultrasound
	Tåsenveien 71, 0873 Oslo
	Phone: [phone]
	Strandpromenaden 45, P.O. Box 141, 3191 Horten
	Phone: [phone]
POLAND	GE Medical Systems Polska
	Sp. z o.o., ul. Wołoska 9
	02-583 Warszawa, Poland
	Phone: [phone]
	Fax: [phone]
PORTUGAL	General Electric Portuguesa
	SA. Avenida do Forte, n° 4
	Fraccao F, 2795-502 Carnaxide
	Phone: [phone]
	Fax: [phone]
REPUBLIC OF	GE Healthcare
IRELAND	Unit F4, Centrepoint Business Park
	Oak Drive, Dublin 22
	Phone: [phone]
RUSSIA	GE Healthcare
	Krasnopresnenskaya nab., 18, bld A, 10th floor
	123317 Moscow, Russia
	Phone: [phone]
	Fax:[phone]
SINGAPORE	GE Healthcare Singapure
	1 Maritime Square #13-012
	HarbourFront Centre
	Singapore 099253
	Tel: [phone]

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SPAIN	GE Healthcare Espana
	C/ Gobelas 35-37
	28023 Madrid
	Phone: [phone]
	Fax: [phone]
SWEDEN	GE Medical Systems Ultrasound
	PO Box 314
	17175 Stockholm
	Phone: [phone]
SWITZERLAND	GE Medical Systems Ab
	Europastrasse 31
	8152 Glattbrugg
	Phone: [phone]
	Fax: [phone]
TURKEY	GE Healthcare Türkiye
	Istanbul Office TEL: [phone]
	Levent Ofis FAKS: [phone]
	Esentepe Mah. Harman Sok.
	No:8 Sisli-Istanbul
	Ankara Office TEL: [phone]
	Mustafa Kemal Mah. FAKS: [phone]
	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: [phone]
	Phone: [phone]
	Fax: [phone]
UNITED KINGDOM	GE Medical Systems Ultrasound
	71 Great North Road
	Hatfield, Hertfordshire, AL9 5EN
	Phone: [phone]
	Fax: [phone]
USA	GE Healthcare
	Ultrasound Service Engineering
	9900 Innovation Drive
	Wauwatosa, WI 53226
	Phone: [phone]
	Fax: [phone]

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Chapter 2

Safety

Describes the safe handling of the Voluson® iand the warning signs

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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.

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:		Patient population:		Operator profile:
••	Fetal/Obstetrics	•	Age: all ages (incl.	•	Qualified and trained
	Abdominal/GYN (including infertility		embryos and fetuses)		physicians or
	monitoring of follicle development)	•	Location: worldwide		sonographers with at least
•	Pediatric	• Sex: male and female			basic ultrasound
					knowledge.
•	Small Organ (breast, testes, thyroid,	•	Weight: all weight	• The operator must have
	etc.)		categories
•					read and understood the
	Cardiac (fetal cardio)
					user manual.
•	Peripheral Vascular
•	Musculo-skeletal Conventional and
•	Superficial
	Transvaginal and Transrectal

CONTRAINDICATIONS

The Voluson® i 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

2.1Labels 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		This label is a marker used during
	immersion (probes)		manufacturing and has no meaning
			relevant to the usage of the device.
	Caution, consult accompanying		Consult accompanying documents. This
	documents. This symbol advises the user		symbol advises the user to consult the
	to consult the accompanying documents		accompanying documents.
	for important safety-related information
	such as warnings and pre-cautions that
	cannot be presented on the device itself.
	This symbol is followed by the name and		This symbol is followed by the
	address of the manufacturer.		manufacturing date in the format YYYY-
			MM.
	Pictogram on Probe Care Card:		Pictogram on Probe Care Card:
	Use care when handling ultrasound		Do not immerse the probe into any liquid
	probes and protect the probe head from		beyond the level specified for that probe.
	damage.		Refer to the user manual of the
			ultrasound system.
	Pictogram on Probe Care Card:		Pictogram on Probe Care Card:
	Describes precautions necessary to		Describes precautions necessary to
	prevent the risk of disease transmission		prevent the risk of injury through electric
	or infections.		hazards.
	This symbol is followed by the serial		Batch or lot number
	number of the device.

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	Catalog or model number.		Disposal:
			'Disposal' on page 2-15
	NRTL Classification Label (old and new		GOST-R Label
	version)
	CE Conformity mark according to Medical		This product consists of devices that may
	Device Directive 93/42/EEC		contain mercury, which must be recycled
	0123: Identification number of the notified		or disposed of in accordance with local,
	body TÜV SÜD Product Service		state, or country laws. (Within this
			system, the backlight lamps in the
			monitor display, contain mercury.)
	This symbol indicates PSE rating -	Green	Indicates that the power cable is hospital
	required for Japanese market	dot on	grade. Grounding reliability can only be
		power	achieved when the equipment is
		cable	connected to an equivalent receptacle
		plug	marked “Hospital only” or “Hospital
			grade”. Applicable depending on local
			regulatory requirements.
	This symbol indicates the voltage that the		This indicates the maximum rated power
	device is built for. This device requires		consumption of the system.
	direct current.
	This label represents the license of the		Indicates a USB connector.
	operating system used on this device.
	Indicates a monitor connector		Indicates a network connector.
	Indicates the battery status LED. 'LED		Indicates the power status LED. 'LED
	Status Table' on page 3-6		Status Table' on page 3-6
	This symbol indicates the connector for a		Indicates a docking connector for
	theft protection lock.		connecting the system to the Voluson
			Station.
	Indicates the locking mechanism for the		Contains marketing information about
	probe connector.		VolusonClub. For more information
			please contact your local sales person.
	This symbol indicates that the power		Do not reuse! This symbol indicates that
	supply has passed the quality check		the item/device is for single use only.
	(optional)

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				Safety
		These symbols indicate that at least one		This symbol indicates that in the United
		of the six hazardous substances of the		States of America, federal law restricts
		China RoHS Labelling Standard is above		this device to sale by or on the order of a
		the RoHS limitation. The number inside		physician.
		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 = 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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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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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. 'Power supply' on page 20-4

CAUTION

Laser radiation

Avoid exposure to the beam Class 3B laser product

CAUTION

Class 3B laser radiation When open avoid exposure to the beam

2.3 Electric installation

The system must be exclusively installed in medically used rooms. The equipment conforms with regulations for electrical safety (IEC 60601) and safety class IIa according to the MDD 93/42/EEC regulation for use on human patients. Ultrasound probes are rated Type BF. Local safety regulations may require an additional connection between the potential equilibrium bolt and the building’s grounding system.

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Before switching on the first time, the local mains voltage and frequency are to be checked against the values indicated on the Voluson® i rating plate located on the bottom cover. 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.

2.4Remarks 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!

•Do not squeeze, kink, bend or twist probe cables and protect them against mechanical damage.

•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.

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

•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).

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2.5 Environmental Conditions for Operation

	For more information see 'Basic Data' on page 20-2.
Note	The system is easily portable between rooms.
	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.

2.7Biopsy Lines

To achieve best possible accuracy of the display of the needle path, the biopsy lines have to be programmed for each transducer. See ' To program a Single Angle Biopsy Line' on page 17-22 and 'To program a Multi Angle Biopsy Line' on page 17-23.

•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. 47ºC 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.

Depending on the needle stiffness/thickness and the elasticity and composition of the different tissue-types in the path of the biopsy needle, the actual needle track can deviate from the predicted biopsy line. The biopsy needle might bend and not follow a straight line.

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2.8 Cleaning and Maintenance

Have the system checked and serviced in regular intervals (once per year) by authorized service personnel. In case of total failure first check if main voltage is present. Mentioning any observations or failure symptoms to the service engineers is helpful.

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 touch panel screen clean. Dust and grime on the frame can cause irregular function! Check the main cable, transducer cables, plugs and sockets on a regular basis.

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, and are an infringement to regulations and are inadmissible acc. to IEC 60601-1. For expected lifetime of equipment and probes see Service Manual.

The following table provides cleaning instructions for the ultrasound device. Effective cleaning and disinfection is not possible for parts with narrow gaps and holes (e.g. keyboard, trackball,...). It is the responsibility of the user to decide which cleaning and disinfection procedure is necessary to ensure a safe working environment. Electrical contacts and connectors must not be cleaned. Do not use any other cleaning agents than listed in the table below. Do not spray any liquid directly on the system.

Note	The cleaning instructions apply to Voluson ® i/e, Voluson® Station and Voluson® Dock Cart.
Component		When	How to clean		Cleaning agent
Probe holder		daily or after	Wipe gently with a damp,	•	IPA solution (70% IPA, 30%
		each	non-abrasive cloth.	•	water)
		examination			Sani-Cloth Active disinfecting
				•	wipes
					Acryl des®
Probes		daily or after	See Probe Care Card and 'Special Handling Instructions' on
		each	page 18-10
		examination
User interface		daily or after	Wipe gently with a damp,	•	Spiritus dilutus (70% ethanol,
		each	non-abrasive cloth.	•	30% water)
		examination			Acryl des®
Monitor display		daily or after	Wipe gently with	Petroleum benzene
		each	absorbent cotton or other
		examination	soft material like chamois.
Housings		daily or after	Wipe gently with a damp,	•	IPA solution (70% IPA, 30%
		each	non-abrasive cloth.	•	water)
		examination			Sani-Cloth Active disinfecting
				•	wipes
					Acryl des®
Peripherals (e.g.		Clean according to the instructions of the peripheral manufacturer.
printers,...)

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2.8.1 Safety Test

Scan time limits: According to respective national regulations, and according to the manufacturer recommendations for the medical-technical system.

Range:

a)	Visual inspection:	Housing, connection, operating elements, display facilities, labels,
		accessories, user manual.
b)	Functional test:	Checking of functions (according 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 according to
		EN 62353 or respective national regulations.

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

Item	Safety Test	Notes
Console Leakage Current	Annually	Also after corrective maintenance or as required
Checks		by your facilities QA program.
Peripheral Leakage	Annually	Also after corrective maintenance or as required
Current Checks		by your facilities QA program.
Surface Probe Leakage	Annually	Also after corrective maintenance or as required
Current Checks		by your facilities QA program.
Endocavity Probe	Annually	Also after corrective maintenance or as required
Leakage Current Checks		by your facilities QA program.

2.9 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: 'Backup' on page 16-16

The directory structure of the full backup data is as follows:

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Every “Full Backup” resides in a sub-folder of the main “fullbackup”-folder found at the root of the drive. For example: Z:\fullbackup.

The sub-folders have the names fbX where X is a number (e.g., Z:\fullbackup\fb1). The data resides within a directory structure within these sub-folders. 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!

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.

2.11Service 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

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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.

2.12 Bioeffects and Safety of Ultrasound Scans

When ultrasound waves travel through tissue, there is a certain risk for damage. There has been a lot of research on the impact that high frequency waves can have on different kinds of tissues under defined conditions and “There is, to date, no evidence that diagnostic ultrasound has produced any harm to humans – including the developing fetus.” (Guidelines for the safe use of diagnostic ultrasound equipment, Safety Group of the British Medical Ultrasound Society 2010).

Physiological effects due to ultrasound are generally assumed to be deterministic and only occur above a certain threshold in contrast to ionizing radiation, which causes effects accidentally. Thus ultrasound examinations can be held very safe if certain proceedings are followed. It is therefore recommended to read the following sections and study the cited literature.

2.12.1 Prudent Use – ALARA Principle

In spite of the relatively low risk of ultrasound scans compared to other imaging techniques, the operator shall choose the exposure level with caution to minimize the risk of bioeffects.

“A fundamental approach to the safe use of diagnostic ultrasound is to use the lowest output power and the shortest scan time consistent with acquiring the required diagnostic information. This is the ALARA principle (i.e. As Low As Reasonably Achievable). It is acknowledged that in some situations it is reasonable to use higher output or longer examination times than in others: for example, the risks of missing a fetal anomaly must be weighed against the risk of harm from potential bioeffects. Consequently, it is essential for operators of ultrasound scanners to be properly trained and fully informed when making decisions of this nature.” (Guidelines for the safe use of diagnostic ultrasound equipment, Safety Group of the British Medical Ultrasound Society 2010)

Special care regarding ALARA should be taken with obstetric examinations as any potential bioeffects are likely to be of greatest significance in the embryo or fetus.

It is strongly recommended to consider ALARA when undertaking ultrasound scans.

2.12.2Bioeffects

•Thermal effects refer to heating of soft tissue and bone

The thermal indices TIs (soft tissue), TIb (bone near focus) and TIc (bone near surface) were introduced to provide the operator a relative potential for a tissue temperature rise. According to the Standard for Real-time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment (2004) those thermal indices shall be displayed by this ultrasound console. It should be noted that a TI of 1 does not necessarily mean that tissues being scanned will increase in temperature by 1˚C – almost every scanning situation departs from the assumed model conditions, such as tissue type, blood perfusion, mode of operation and actual exposure time of the scanned area. However, the thermal indices provide information regarding the possible increase in the risk of potential thermal bioeffects and it provides a relative magnitude that can be

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used to implement ALARA. In addition to tissue heating due to the generated ultrasound field, the temperature of the probe head itself can also increase during the examination. The operator shall be aware, that in the tissue region near the ultrasonic transducer, there will be a superposition with the heating due to the ultrasound field, which is not considered by the TI values.

•Nonthermal effects refer to mechanical phenomena such as cavitation

Nonthermal bioeffects are caused by the interaction of ultrasound fields with very small pockets of gas (stabilized gas bodies), i.e. the generation, growth, vibration and possible collapse of microbubbles within the tissue. This behavior is referred to as cavitation (Medical Ultrasound Safety, 2nd Edition, AIUM 2009/American Institute of Ultrasound in Medicine Consensus Report on Potential Bioeffects of Diagnostic Ultrasound, AIUM 2008/Guidelines for the safe use of diagnostic ultrasound equipment, Safety Group of the British Medical Ultrasound Society 2010). The potential of cavitation increases with the rarefactional peak pressure but decreases with the pulse frequency. Therefore the Mechanical Index MI was introduced to take account of both the pressure and the frequency. The higher the MI the greater is the risk of nonthermal bioeffects.

2.12.3Regulated Parameters

Relevant parameters having physiological effects (For more information see 'Bioeffects' on page 2-13.) are regulated according to FDA and IEC guidelines and standards. These parameters are

Parameter	Meaning	Limit	Displayed
MI	Mechanical Index	1.9	Yes
TIs, TIb, TIc	Thermal Indices TI – one of the	6	Yes
	following values can be displayed:
	TIs: soft tissues
	TIb: bone in focal region
	TIc: bone at surface (e.g. cranial)
Ispta.3	Averaged intensity at spatial peak	720 mW/cm2	No
	with a derating of 0.3dB/(cm MHz)
T	Temperature at the patient’s side of	43˚C/50˚C	No
	the probe – lower limit during patient	(109.4˚F/122˚F)
	contact, higher limit for rest position

2.12.4 Interpretation of displayed parameters MI and TI

During obstetric examinations these displayed values shall be observed very critically, because there may be conditions that are potentially hazardous even below the regulatory limits.

Some guidelines recommend that embryonic and fetal in situ temperatures of 41˚C (4˚C above normal temperature) should be limited in time by 5 min or less. Thus, for a reasonable safety margin, TI values above 1 should be avoided. Additional factors, like fever of the mother, are again reasons to keep the TI values as low as possible on the one hand, and go only as high as necessary to achieve the desired clinical results ('Prudent Use – ALARA Principle' on page 2-13).

The mechanical index, which indicates the risk of cavitation, becomes important at the interface between gas and soft tissue (nonfetal lung and bowel), but also with the use of gas body contrast agents. Often an MI value of 0.4 or less is suggested for examinations of tissue

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containing stabilized gas bodies. This value arises from operating experience and is not confirmed.

Some examples where the MI and TI, respectively, are more or less important are shown in the following table according to Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment, IEC 60601-2-37 2nd Edition, 2007, Annex CC.

	Of greater importance	Of less importance
MI –	With contrast agents	In the absence of gas bodies, i.e. most
Mechanical	Cardiac scanning (lung exposure)	tissue scanning
Index	Abdominal scanning (bowel gas)
TI –	1st trimester scanning	Well perfused tissue, i.e. liver, spleen
Thermal	Fetal skull and spine	Cardiac scanning
Indices	Neonatal head	Vascular scanning
	Patient with fever
	Poorly perfused tissue
	Scanning near ribs or bone: TIb

Further information can be retrieved from Bioeffects & Safety of Diagnostic Ultrasound, AIUM, 1993 and Evaluation of Research Reports: Ultrasound Bioeffects Literature Reviews (1992-2003).

2.12.5 Reporting Tables

Acoustic output reporting tables according to the below cited standards are provided in the

Basic Service Manual.

Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment, IEC 60601-2-37 2nd Edition, 2007.

Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and transducers, FDA Guidance, 2008.

Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields, IEC 62359 1st Edition, 2005.

2.13 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 an other authorized disposal company to decommission your equipment according to local regulations.

2.13.1 Battery disposal

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Lithium battery included with this device. Do not puncture, mutilate or dispose of battery in fire. Replace only with same type recommended by the manufacturer. Dispose of used battery according to manufacturers instructions and in accordance with your local regulations.

2.14 Guidance and manufacturer´s declaration

Guidance and manufacturer´s declaration - electromagnetic emissions

The Voluson® i is intended for use in electromagnetic environment specified below. The customer or the user of the Voluson® i should assure that it is used in such an environment.

	Emission test	Compliance	Electromagnetic environment - guidance
	RF emissions - CISPR 11	Group 1	The Voluson® i uses RF energy only for its internal
			function. Therefore, its RF emissions are very low and
			are not likely to cause any interference in nearby
			electronic equipment.
	RF emissions - CISPR 11	Class A	The Voluson® i is suitable for use in all establishments
			(i.e. hospitals, doctors practice etc.) other than
	Harmonic emissions IEC	Class A
			domestic. The Voluson® i is intended for professional
	61000-3-2
			use only.
	Voltage fluctuations/	Complies
	flicker emissions IEC
	61000-3-3

Guidance and manufacturer´s declaration - electromagnetic immunity

The Voluson® i is intended for use in electromagnetic environment specified below. The customer or the user of the Voluson® i should assure that it is used in such an environment.

Immunity test	IEC 60601 test level	Compliance level	Electromagnetic
			environmentguidance
Electrostatic discharge	± 2,4,6 kV contact	± 2,4,6 kV contact	Floors should be wood,
(ESD) IEC 61000-4-2	± 2,4,8 kV air	± 2,4,8 kV air	concrete or ceramic tile. If
			floors are covered with
			synthetic material, the
			relative humidity should be
			at least 30 %.
Electrical fast transient/	± 2kV for power supply	± 2kV for power supply	Mains power quality
burst IEC 61000-4-4	lines	lines	should be that of a typical
	±1kV for input/output lines	±1kV for input/output lines	commercial or hospital
			environment.
Surge IEC 61000-4-5	± 1kV differential mode	± 1kV differential mode	Mains power quality
	± 2kV common mode	± 2kV common mode	should be that of a typical
			commercial or hospital
			environment.

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