Voluson S6, S8, S8 Pro Basic User Manual Rev 2 SW 14.0.0 Jan 2015

Revision History

Revision

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Date

Revision 1

October 2014

Revision 2

January 2015

Voluson™ S6 / Voluson™ S8 / Voluson™ S8 Pro Basic User Manual 5573127-100 Revision 2

Table of Contents Chapter 1 – General Contacting GE - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-2 Manufacturer - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-6 About this User Manual - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-7

Chapter 2 – Safety Warning labels used in the Basic User Manual - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-3 Symbols and Labels used on the system - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-3 Classification - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-5 Remarks for Safe Use - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-6 System Safety and Maintenance - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-7 Probe Safety and Maintenance - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-13 Biopsy Safety and Maintenance - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-18 Battery Safety and Maintenance - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-19 Manufacturer Responsibility - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-20 Service Documents - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-20 Bioeffects and Safety of Ultrasound Scans - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-21 Disposal - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-23 Network disclosure - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-24

Chapter 3 – Description of the System Product Description - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-2 System Assembly - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-3 Mechanical Adjustment - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-3 Concept of Operation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-7 Layout of Menus - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-7 Button description - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-10 Remove USB Devices - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-14 Electronic User Manual (EUM) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-14

Chapter 4 – Operating the System General Remarks - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-2 Safety Warnings - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-2 Power On / Boot Up - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-2 Power Off / Shutdown - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-3 Transducer Connection - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-4 Prepareing the Transducer - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-5 Probe/Program Selection - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-7 Entering Patient Data - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-9 Image Annotation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-26

Chapter 5 – Probes and Biopsies Probes - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-2 Biopsies - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-10

Chapter 6 – 2D Mode 2D Main Menu - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-2 2D Operation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-3 Cine Mode - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-14 2D Sub Menu - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-18 Gray Map - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-20 B-Flow - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-21

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Table of Contents XTD-View (Extended View) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-24 Contrast Imaging - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-31

Chapter 7 – M Mode M Main Menu - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-2 M Operation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-3 M Sub Menu - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-6 MCF Mode (M Color Flow Mode) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-7 MTD Mode (M Tissue Doppler Mode) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-11 MHDF Mode (MHD-Flow Mode) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-15 STIC with M-Mode - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-19 Anatomical M-Mode (AMM) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-19

Chapter 8 – Doppler Modes Pulsed Wave Doppler Mode (PW Mode) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-2 Continuous Wave Doppler Mode (CW Mode) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-7 Color Flow Mode (CFM) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-10 Power Doppler Mode (PD Mode) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-15 HD-Flow Mode (Bi-directional Angio Mode) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-20 Tissue Doppler Mode (TD Mode ) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-25 Doppler Mode Functions and Filters - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-29

Chapter 9 – Volume Mode Volume Acquisition with Volume Probes - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-2 Volume Acquisition: Static 3D Sectional Planes - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-15 Sub Menus - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-38 Volume Acquisition: Static 3D Render - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-42 Real Time 4D Acquisition - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-71 Sono Render Start - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-87 Volume Cine - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-88 Volume Contrast Imaging: (VCI A-Plane) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-91 VCI-Omniview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-93 STIC (Spatio-Temporal Image Correlation) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-98 Real Time 4D Biopsy - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-103 VOCALII - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-106 SonoAVC Follicle - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-120 VCAD Heart - Volume Computer Aided Display - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-126 SonoVCAD labor - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-133 HDlive - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-139

Chapter 10 – Elastography Mode GUI elements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-2 Elastography Main Menu - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-3 Elastography Sub Menu - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-5 Elastography Sub Menu 2 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-6

Chapter 11 – Measurements and Patient Worksheets (Reports) Generic Measurements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-2 Calculations and Worksheets - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-24 Basic Calculation Functionality - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-95 Basic Patient Worksheet Functions - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-97 Measure Setup - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-104

Chapter 12 – Archive Current Patient Dialog - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-3

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Voluson™ S6 / Voluson™ S8 / Voluson™ S8 Pro Basic User Manual 5573127-100 Revision 2

Table of Contents Clipboard - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-6 Patient Archive - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-10 Image History - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-33 Exam Review - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-34 Selecting Exams - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-41 Settings - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-42

Chapter 13 – Utilities and System Setup Utilities - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-2 System Setup - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-10

Chapter 14 – Programmable Keys Where to program the keys - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 14-2 P-keys - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 14-4 Start Exam Button - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 14-8 End Exam Button - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 14-9

Chapter 15 – Connections How to Connect Auxiliary Devices Safely - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 15-2 To Connect Internal and External Accessories - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 15-3 Connection between Internal I/O and External I/O - - - - - - - - - - - - - - - - - - - - - - - - - - 15-4 Recorder type - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 15-7 Connection of Peripherals - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 15-9 External Monitor - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 15-11 Isolating transformer Noratel IMED 300WR - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 15-12 ECG Module - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 15-12 Battery Pack - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 15-17

Chapter 16 – Technical Data / Information Safety Conformance - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-2 Physical Attributes - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-3 System overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-5 Screen Formats - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-6 Display Modes - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-7 Display Annotation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-7 System Standard Features - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-9 System Options - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-10 System Parameters - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-12 Scanning Parameters - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-16 Generic Measurements and Measurements/Calculations - - - - - - - - - - - - - - - - - - - - 16-25 External Inputs and Outputs - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-29 Guidance and manufacturer´s declaration - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-30

Chapter 17 – ANNEX- Abbreviations

Voluson™ S6 / Voluson™ S8 / Voluson™ S8 Pro Basic User Manual 5573127-100 Revision 2

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Voluson™ S6 / Voluson™ S8 / Voluson™ S8 Pro Basic User Manual 5573127-100 Revision 2

Chapter 1 General This chapter consists of information concerning indications for use and contact information.

Contacting GE - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-2 Manufacturer - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-6 About this User Manual - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-7

Voluson™ S6 / Voluson™ S8 / Voluson™ S8 Pro Basic User Manual 5573127-100 Revision 2

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General The Voluson™ S6 / Voluson™ S8 / Voluson™ S8 Pro is a professional diagnostic Ultrasound System which transmits Ultrasound waves into body tissues and forms images from the information contained within the received echoes. The Voluson™ S6 / Voluson™ S8 / Voluson™ S8 Pro 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™ S6 / Voluson™ S8 / Voluson™ S8 Pro is developed and produced by GE Healthcare. For more Information, please contact: GE Healthcare Telephone

+(82) 31-740-6273

Internet

http://www.gehealthcare.com

9, Sunhwan-ro 214beon-gil, Jungwon-gu, Seongnam-si, Gyeonggi-do, Korea Authorized EU Representative GE Medical Systems Information Technologies GmbH Munzingerstrasse-5, 79111 Freiburg, Germany Dear Valuable Customer,We here with would like to inform you that the American Institute of Ultrasound in Medicine (AIUM) advocates the responsible use of diagnostic ultrasound. The AIUM strongly discourages the non-medical use of ultrasound for psychosocial or entertainment purposes. The use of either two-dimensional (2D) or three-dimensional (3D) ultrasound to only view the fetus, obtain a picture of the fetus or determine the fetal gender without a medical indication is inappropriate and contrary to responsible medical practice. Although the general use of ultrasound for medical diagnosis is considered safe, ultrasound energy has the potential to produce biological effects. Ultrasound bioeffects may result from scanning for a prolonged period, inappropriate use of color or pulsed Doppler ultrasound without a medical indication, or excessive thermal or mechanical index settings (American Institute of Ultrasound in Medicine: Keepsake Fetal Imaging; 2005). Thus ultrasound should be used in a prudent manner to provide medical benefit to the patient.

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

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

Clinical Questions

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

Service Questions

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

Information Request

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

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Voluson™ S6 / Voluson™ S8 / Voluson™ S8 Pro Basic User Manual 5573127-100 Revision 2

General

Placing an Order

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

ARGENTINA

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

ASIA PACIFIC JAPAN

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

AUSTRALIA NEW ZEALAND

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

AUSTRIA

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

BELGIUM &

GE Medical Systems Ultrasound Eagle Building

LUXENMBUR G

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

BRAZIL

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

CANADA

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

Voluson™ S6 / Voluson™ S8 / Voluson™ S8 Pro Basic User Manual 5573127-100 Revision 2

Phone: (1) 262-524-5698

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General

CHINA

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

CZECH REPUBLIC

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

DENMARK

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

ESTONIA &

GE Medical Systems

FINLAND

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

FRANCE

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

GERMANY

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

GREECE

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

HUNGARY

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

INDIA

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

ITALY

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

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General

KOREA

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

LUXEMBOUR G

Phone: 0800 2603 toll free

MEXICO

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

NETHERLAN DS

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

NORTHERN IRELAND

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

NORWAY

GE Medical Systems Ultrasound Tåsenveien 71, 0873 Oslo Phone: (+47) 23 18 50 50 Strandpromenaden 45, P.O. Box 141, 3191 Horten Phone: (+47) 33 02 11 16

POLAND

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

PORTUGAL

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

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

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

SINGAPORE

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

Voluson™ S6 / Voluson™ S8 / Voluson™ S8 Pro Basic User Manual 5573127-100 Revision 2

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General

SPAIN

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

SWEDEN

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

SWITZERLAN D

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

TURKEY

GE Healthcare Türkiye Istanbul Office TEL: +90 212 398 07 00 FAKS: +90 212 284 67 00 Esentepe Mah. Harman Sok. 34394 No:8 Sisli-Istanbul Ankara Office TEL: +90 312 289 77 00 Mustafa Kemal Mah. FAKS: +90 312 289 78 02 2158.Sok No:9 Çankaya-Ankara

United Arab Emirates (U.A.E.)

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

UNITED KINGDOM

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

USA

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

1.2 Manufacturer GE Ultrasound Korea, Ltd. 9, Sunhwan-ro 214beon-gil, Jungwon-gu, Seongnam-si, Gyeonggi-do, Korea

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General

1.3 About this User Manual

•

Read and understand all instructions in the Basic User Manual before attempting to use the Voluson™ S6 / Voluson™ S8 / Voluson™ S8 Pro .

•

This Manual has to be used in connection with the Voluson™ S6 / Voluson™ S8 / Voluson™ S8 Pro .

• •

Keep this User Manual with the equipment at all times.

•

All information contained in the Voluson™ S6 / Voluson™ S8 / Voluson™ S8 Pro User Manual is relevant. Periodically review the procedures for operation and safety precautions.

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

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

It might be possible that some probes, options or features are NOT available in some countries.

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Voluson™ S6 / Voluson™ S8 / Voluson™ S8 Pro Basic User Manual 5573127-100 Revision 2

Chapter 2 Safety Describes the safety and regulatory information pertinent for operating this ultrasound system.

Warning labels used in the Basic User Manual - - - - - - - - - - - - - - - - - - - - - - - - - 2-3 Symbols and Labels used on the system - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-3 Classification - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-5 Remarks for Safe Use - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-6 System Safety and Maintenance - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-7 Probe Safety and Maintenance - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-13 Biopsy Safety and Maintenance - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-18 Battery Safety and Maintenance - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-19 Manufacturer Responsibility - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-20 Service Documents - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-20 Bioeffects and Safety of Ultrasound Scans - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-21 Disposal - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-23 Network disclosure - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-24

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Safety The Voluson™ S6 / Voluson™ S8 / Voluson™ S8 Pro scanner system has been designed for utmost safety for patient and user. Read the following chapters thoroughly before you start working with the machine! The manufacturer guarantees safety and reliability of the system only when all the following cautions and warnings are observed. INDICATIONS FOR USE This system is intended for use by a qualified physician for ultrasound evaluation in the following clinical applications: Image Acquisition for diagnostic purposes incl. measurements on acquired image. Clinical applications:

Patient population:

• • • • • • • • • • •

• Age: all ages (encl. embryos and • Qualified and trained physicians or

Abdominal

fetuses)

Small Parts

Operator profile:

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

Obstetrics Gynecology Cardiology

sonographers with at least basic ultrasound knowledge.

• The operator must have read and understood the user manual.

Urology Peripheral Vascular Pediatrics Neurology MSK Breast

CONTRAINDICATIONS The Voluson™ S6 / Voluson™ S8 / Voluson™ S8 Pro system is not intended for:

• •

ophthalmic use or any use causing the acoustic beam to pass through the eye. The system is not intended for intra-operative use except vagina and rectum.

Federal law restricts this device to sale by or on the order of a physician!

Describes general precautions necessary to protect health and the equipment.

Describes important information that has to be read before proceeding.

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

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

Describes precautions necessary to prevent the risk of injury through explosion hazard!

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Safety

Describes precautions necessary to prevent the risk of injury through moving or tipping hazard!

Describes precautions necessary to prevent the risk of injury through mechanical hazard!

2.1 Warning labels used in the Basic User Manual 2.2 Symbols and Labels used on the system Some symbols and labels used with electrical medical equipment have been accepted as standard by IEC. They serve for marking connections, accessories, and as warnings. Stand-by

Insulated patient application part (Type BF)

Mains power(Circuit Breaker) switch ON

Mains power(Circuit Breaker) switch OFF

Do not use the following devices near this equipment: cellular phone, radio receiver, mobile radio transmitter, radiocontrolled toy, broadband power lines,etc. Use of these devices near this equipment could cause this equipment to perform outside the published specifications. Keep power to these devices turned off when near this equipment.

Protective earth (ground) connection

Potential equilibrium connection (equipotentiality)

UL conformity mark according to UL 60601-1 and CAN/CSA C22/2 NO. 601.1:

Protection against the effects of immersion

Caution, consult accompanyingdocuments.This symbol advises the reader toconsult the accompanyingdocuments for important safety related information such as warnings and pre-cautions thatcannot be presented on the device itself.

Dangerous electric voltage. Unplug the main plug before opening the system!

Disposal:

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

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

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'Disposal' on page 2-23

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Safety

This symbol signifies that the user manual must be read

Tipping danger. Do not lean on the cart and take special care when moving!

ECG symbol

DO NOT place a finger, hand or any object on the joint of the monitor or monitor arm to avoid injury when moving the monitor and monitor arm.

The monitor has to be secured with the monitor-transportlock when moving or transporting.

Defibrillation-proof CF applied part

Indicates an USB 2.0 connector.

Indicates a network connector.

Connect the monitor cable to this connector.

Indicates an USB 1.1 connector.

Connect the SATA cable for DVD to this connector.

Connect the MIC cable to this connector.

• 100-120V/220-240V~: Outlet, This text

• 100-120V/220-240V~ : Inlet, This text

• 50/60Hz: This indicates the electrical

• 900VA: Max Power Consumption • 50/60Hz: This indicates the electrical

indicates the voltages that the device is built for. Please note that either the first voltage range OR the second voltage range is applicable depending on your country’s voltage. This device uses alternating current.

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

indicates the voltages that the device is built for. Please note that either the first voltage range OR the second voltage range is applicable depending on your country’s voltage. This device uses alternating current.

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

There are two pieces of DC power. (The left one is for DVD power and the right one is for V-Navi power.)

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Push this button to eject a CD/DVD from the drive.

These symbols indicate that the DVD drive can read and write DVDs.

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

Use these buttons to navigate in the monitor menu.

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Safety

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

Identification and Rating Plate

Identification and Rating Plate

• Manufacturer’s name and address • Date of manufacture • Model and serial numbers • Electrical ratings (Volts, Amps, phase,

Date of manufacture

and frequency)

Serial Number

Catalog Number

This symbol is attached on the rear part of the system to indicate required caution and information. The machine should be used in compliance with law some jurisdictions restrict certain use such as gender determination.

This label is printed on the packing box of the system to indicate the humidity, temperature and air pressure condition for the storage and shipment.

2.3 Classification Classifications Type of protection against electric shock

•

Class I Equipment (*1)

Degree of protection against electric shock

• •

Type BF Applied part (*2) (for all Probes) Type CF Applied part (*3) (for ECG marked with CF symbol)

Continuous Operation System is Ordinary Equipment (IPX0) Footswitch is IPX8 Probe head (immersible portion) is IPX7 *1. Class I Equipment EQUIPMENT in which protection against electric shock does not rely on BASIC INSULATION only, but includes an earth ground. This additional safety precaution prevents exposed metal parts from becoming LIVE in the event of an insulation failure. *2. Type BF Applied Part

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Safety TYPE BF APPLIED PART providing a specified degree of protection against electric shock, with particular regard to allowable LEAKAGE CURRENT. *3. Type CF Applied Part TYPE CF APPLIED PART providing a degree of protection higher than that for Type BF Applied Part against electric shock particularly regarding allowable LEAKAGE CURRENTS.

2.4 Remarks for Safe Use

•

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

• •

Misinterpretation of an Ultrasound Image can lead to false diagnosis.

•

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.

•

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 will void the 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!

•

For safety reason, avoid handling fluids in the vicinity of the system. Fluids leaking into the disk drive can damage the drive.

•

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

•

Only ultrasound probes conforming to type BF requirements may be used with the Voluson™ S6 / Voluson™ S8 / Voluson™ S8 Pro .

•

Do not install software on the system, that has not been released by GE Healthcare, as this may lead to erroneous data transfer and thereby decrease system performance.

•

The Voluson™ S6 / Voluson™ S8 / Voluson™ S8 Pro system has been tested for EMC and is compliant with CISPR11 group 1 class B and IEC60601-1-2. The Voluson™ S6 / Voluson™ S8 / Voluson™ S8 Pro 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.

•

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

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

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

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

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