Voluson P6 and P8 Basic User Manual Rev 2 Aug 2012

Revision History

Revision

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Date

Revision 1

March 2012

Revision 2

August 2012

Voluson® P6/P8 Basic User Manual 5454053-100 Revision 2

Table of Contents Chapter 1 – General Contacting GE Healthcare Ultrasound - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-2 About this User Manual - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-7 Regulatory Requirement - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-8

Chapter 2 – Safety and Maintenance Symbols and Labels - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-3 Remarks for Safe Use - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-7 System Safety and Maintenance - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-8 Probe Safety and Maintenance - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-15 Biopsy Safety and Maintenance - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-23 Manufacturer Responsibility - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-25 Service Documents - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-25 Bioeffects and Safety of Ultrasound Scans - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-26 Disposal - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-29 Guidance and manufacturer´s declaration - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-29 Network disclosure - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-32

Chapter 3 – Description of the System Product Description - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-2 System Assembly - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-3 Mechanical Adjustment - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-4 Concept of Operation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-5 Layout of Menus - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-5 Button description - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-9 Electronic User Manual (EUM) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-13

Chapter 4 – Operating the System General Remarks - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-2 System Start-Up - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-2 Probe connection and selection - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-5 Entering Patient Data - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-7 Image Annotation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-24

Chapter 5 – Probes and Biopsies Probes - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-2 Biopsies - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-5 Overview of all probes and biopsies - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-10

Chapter 6 – 2D Mode 2D Main Menu - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-2 2D Operation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-3 Cine Mode - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-14 2D Sub Menu - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-16 Gray Map - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-19 XTD-View (Extended View) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-20

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

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Table of Contents MHD Flow Mode (M High Definition Flow Mode) - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-11

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 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-19 Doppler Mode Functions and Filters - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-24

Chapter 9 – Volume Mode Volume Acquisition with Volume Probes - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-2 Volume Acquisition: Static 3D Sectional Planes - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-13 Sub Menus - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-41 Volume Acquisition: Static 3D/4D Render - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-43 Real Time 4D Acquisition - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-65 Sono Render Start - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-81 Volume Cine - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-81

Chapter 10 – Measurements Generic Measurements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-2

Chapter 11 – Calculations and Patient Worksheets (Reports) Calculation Packages - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-2 Basic Calculation Functionality - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-2 Basic Patient Worksheet Functions - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-5 Abdomen Calculations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-12 Small Parts Calculations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-22 Obstetric Calculations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-25 Cardiac Calculations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-41 Urology Calculations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-61 Vascular Calculations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-63 Gynecology Calculations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-66 Pediatric Calculations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-69 Neurology Calculations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-73 MSK Calculations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-75

Chapter 12 – Archive Current Patient Dialog - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-3 Patient Archive - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-5 Exam Review - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-23 Selecting Exams - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-30 Settings - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-32

Chapter 13 – Utilities and System Setup Utilities - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-2 System Setup - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-7

Chapter 14 – Programmable Keys Where to program the keys - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 14-2 P-keys - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 14-3 Start Exam Button - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 14-9 End Exam Button - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 14-10

Chapter 15 – Measure Setup To Invoke the Setup Procedure - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 15-2

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Table of Contents To Exit from the Measure Setup - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 15-3 The Measure Setup Pages - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 15-3

Chapter 16 – Connections How to Connect Auxiliary Devices Safely - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-2 Connection between Internal I/O and External I/O - - - - - - - - - - - - - - - - - - - - - - - - - - 16-5 Recorder type - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-7 Connection of Peripherals - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-9 User installable Peripherals - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-9 Foot Switch (GP 26) Connection - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-9 WLAN Adapter - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-10 External Monitor - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-10 ECG Module - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16-10

Chapter 17 – Technical Data / Information Safety Conformance - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 17-2 Physical Attributes - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 17-4 System overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 17-6 Screen Formats - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 17-7 Display Modes - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 17-7 Display Annotation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 17-8 System Standard Features - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 17-11 System Options - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 17-12 System Parameters - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 17-13 Scanning Parameters - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 17-17 Generic Measurements and Measurements/Calculations - - - - - - - - - - - - - - - - - - - - 17-23 External Inputs and Outputs - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 17-29

Chapter 18 – Glossary- Abbreviations

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Voluson® P6/P8 Basic User Manual 5454053-100 Revision 2

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

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General The Voluson® P6/P8 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® P6/P8 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® P6/P8 is developed and produced by GE Healthcare. For more Information, please contact: GE ULTRASOUND KOREA, LTD. 65-1, Sangdaewon-dong, Jungwon-gu, Seongnam-si, Gyeonggi-Do, 462-120, Republic of Korea Telephone: +(82) 31-740-6273 Internet: http://www.gehealthcare.com Dear Valuable Customer, We herewith would like to inform you that the American Institute of Ultrasound in Medicine (AIUM) advocates the responsible use of diagnostic ultrasound. The AIUM strongly discourages the non-medical use of ultrasound for psychosocial or entertainment purposes. The use of either two-dimensional (2D) or three-dimensional (3D) ultrasound to only view the fetus, obtain a picture of the fetus or determine the fetal gender without a medical indication is inappropriate and contrary to responsible medical practice. Although the general use of ultrasound for medical diagnosis is considered safe, ultrasound energy has the potential to produce biological effects. Ultrasound bioeffects may result from scanning for a prolonged period, inappropriate use of color or pulsed Doppler ultrasound without a medical indication, or excessive thermal or mechanical index settings (American Institute of Ultrasound in Medicine: Keepsake Fetal Imaging; 2005).Thus ultrasound should be used in a prudent manner to provide medical benefit to the patient.

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

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

Clinical Questions

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

Service Questions

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

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Voluson® P6/P8 Basic User Manual 5454053-100 Revision 2

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Information Request

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

Placing an Order

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

ARGENTINA

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

ASIA PACIFIC JAPAN

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

AUSTRALIA NEW ZEALAND

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

AUSTRIA

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

BELGIUM &

GE Medical Systems Ultrasound Eagle Building

LUXENMBURG

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

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General

BRAZIL

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

CANADA

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

CHINA

Phone: (1) 262-524-5698

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

CZECH REPUBLIC

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

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

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GREECE

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

HUNGARY

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

INDIA

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

ITALY

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

KOREA

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

LUXEMBOURG

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

NETHERLANDS

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

NORTHERN IRELAND

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

NORWAY

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

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General

POLAND

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

PORTUGAL

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

REPUBLIC OF IRELAND

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

RUSSIA

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

SINGAPORE

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

SPAIN

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

SWEDEN

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

SWITZERLAND

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

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TURKEY

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

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

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

USA

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

1.2 About this User Manual

• • • • •

Read and understand all instructions in the Basic User Manual before attempting to use the Voluson® P6/P8. This Manual has to be used in connection with the Voluson® P6/P8. Keep this User Manual with the equipment at all times. All information contained in the Voluson® P6/P8 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.

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

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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General

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

1.3 Regulatory Requirement This product complies with regulatory requirements of the following European Directive 93/42/EEC concerning medical devices.

This manual is a reference for the Voluson P6/P8. It applies to all versions of the 13.0.0 software for the Voluson P6/P8 ultrasound system. Authorized EU Representative GE Medical Systems Information Technologies GmbH Munzinger Strasse 3 79111 Freiburg Germany

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Chapter 2 Safety and Maintenance Describes the safety and maintenance information pertinent for operating this ultrasound system and the probes.

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Safety and Maintenance

Sections in this chapter:

• • • • • • • •

'Symbols and Labels' on page 2-3 'Remarks for Safe Use' on page 2-7 'System Safety and Maintenance' on page 2-8 'Probe Safety and Maintenance' on page 2-15 'Biopsy Safety and Maintenance' on page 2-23 'Manufacturer Responsibility' on page 2-25 'Service Documents' on page 2-25 'Disposal' on page 2-29

The Voluson® P6/P8 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. INTENDED USE This system is intended for use by a qualified physician for ultrasound evaluation in the following clinical applications: Image Acquisition for diagnostic purposes including measurements on acquired image. Clinical applications:

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

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

• Cardiac (Adult and Fetal Cardiac) • Peripheral Vascular • Urology • Musculo-skeletal Conventional and

Patient population:

Operator profile:

• Age: all ages (incl.

• Qualified and trained

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

• The operator must have

embryos and fetuses)

categories

• Height: no height limitations

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

Superficial

• Transvaginal CONTRAINDICATIONS The Voluson® P6/P8 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

• • • •

2-2

Acquisition of ultrasound images Display of ultrasound images on main display Measurement on ultrasound images System must remain in a safe condition acc. IEC 60601-1 2nd and 3rd edition.

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Safety and Maintenance

2.1 Symbols and Labels Description of all symbols and labels used on the system and in the basic user manual.

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. Bio Hazard: Describes precautions necessary to prevent the risk of disease transmission or infections. Electric Hazard: Describes precautions necessary to prevent the risk of injury through electric hazards. Explosion Hazard: Describes precautions necessary to prevent the risk of injury through explosion hazards! Moving Hazard: Describes precautions necessary to prevent the risk of injury through moving or tipping hazards! Mechanical Hazard: Describes precautions necessary to prevent the risk of injury through mechanical hazards!

Laser radiation

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

2.1.2 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.

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Safety and Maintenance

2-4

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.

DC Power for DVD/V-Navi

Protective earth (ground) connection

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

Protection against the effects of immersion

Caution, consult accompanying documents. This symbol advises the reader to consult the accompanying documents for important safety related information such as warnings and precautions that cannot 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.)

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

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

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.

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

'Disposal' on page 2-29

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Safety and Maintenance

Connect the external monitor cable to this connector.

Defibrillation-proof CF applied part

Indicates an USB 1.1 connector.

Indicates an USB 2.0 connector.

Indicates a network connector.

GOST-R Label

Connect the SATA cable for DVD to this connector.

Connect the MIC cable to this connector.

• 100-120V/220-240V~: Outlet, This

• 100-120V/220-240V~ : Inlet, This

• 50/60Hz: This indicates the

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

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

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

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

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.

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

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Safety and Maintenance

Identification and Rating Plate

• Manufacturer’s name and address • Model • Electrical ratings (Volts, Amps,

Identification and Rating Plate Date of manufacture

phase, and frequency)

Serial Number

Catalog Number

Pictogram on Probe Care Card:

Pictogram on Probe Care Card:

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

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

Pictogram on Probe Care Card:

Pictogram on Probe Care Card:

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

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

DO NOT USE IF PACKAGE IS DAMAGED

Authorized EU Representative GE Medical Systems Information Technologies GmbH Munzinger Strasse 3 79111 Freiburg Germany

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

The device should not be used after the end of the year, month or day shown. The date shall be expressed as given in ISO 8601, as four digits for the year and, where appropriate, two digits for the month and two digits for the day. The machine should be used in compliance with law some jurisdictions restrict certain use such as gender determination.

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