GE Voluson Swift User manual

Voluson™ SWIFT
Voluson SWIFT+
Instructions For Use
English (English)
5831612-100
Revision 4
PC400
© 2020-21 by General Electric

Revision History
Revision Date
Revision 1 May 2020
Revision 2 August 2020
Revision 3 September 2020
Revision 4 February 2021
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Voluson™ SWIFT / Voluson SWIFT+ Instructions For Use
5831612-100 Revision 4

Table of Contents
Chapter 1 – General
Contacting GE - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-2
Manufacturer - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-7
Safety Conformance - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-7
About these Instructions for use - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-7
About this system - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-8
Chapter 2 – Safety
Symobls and Labels - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-2
Information for safe use - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-8
Electric installation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-11
Environmental conditions for operation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-12
Moving the system - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-13
Operation safety - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-13
Cleaning the system - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-15
Maintenance - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-17
Disposal - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-18
Bioeffects and Safety of Ultrasound Scans - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-18
Guidance and manufacturer´s declaration - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-21
Network disclosure - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-25
CyberSecurity Note - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-28
Service Software – Remote Access - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-29
Software Update - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-30
System messages - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-30
Chapter 3 – System description
Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-2
System Assembly - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-3
The user interface - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-3
Control Panel - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-5
The monitor - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-5
Chapter 4 – Getting started
Powering the system - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-2
Getting started - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-3
Basic operations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-6
Chapter 5 – Probes and Biopsies
Probe safety - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-2
Cleaning and maintenance of probes - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-4
Probes - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-17
Biopsies - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-20
Overview of all probes and biopsies - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-25
Probe assessment tool - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-31
Chapter 6 – 2D Mode
2D Mode screen display - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-2
2D Mode standard features and modes - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-3
2D Mode options - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-15
Chapter 7 – Image management
TGC Slider Controls - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-2
Voluson™ SWIFT / Voluson SWIFT+ Instructions For Use
5831612-100 Revision 4 i-iii

Scan Assistant - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-2
Image Annotation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-6
Cine Mode - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-12
Chapter 8 – 3D and 4D Mode
Visualization - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-2
General advice to obtain good rendered 3D/4D images - - - - - - - - - - - - - - - - - - - - - - - 8-7
Initial Condition of different Probes - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-7
3D/4D Mode screen display - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-9
Volume Pre mode - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-11
Volume Acquisition Modes - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-11
Volume Visualization Modes - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-14
Additional tools - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-27
Chapter 9 – Archive
Open Archive - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-2
Data Transfer - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-6
Source - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-12
Patient ID - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-16
Clipboard - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-20
Chapter 10 – Measurements and Calculations
Measurement Menu - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-3
Generic Measurements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-4
Calculations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-13
Worksheet - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-21
Chapter 11 – System Setup
Home Menu - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-2
System setup - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-4
Chapter 12 – Peripheral Devices
How to Connect Auxiliary Devices Safely - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-2
Peripherals and hardware - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-4
Connection between Internal I/O and External I/O - - - - - - - - - - - - - - - - - - - - - - - - - - 12-4
DVR USB - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-5
ECG Preamplifier - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-7
Battery Pack - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-10
Chapter 13 – Technical Data/ Information
Safety conformance - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-2
Physical Attributes - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-3
System overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-5
Screen Formats - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-6
Display Modes - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-6
Display Annotation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-7
System Standard Features - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-10
System Options - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-11
System Parameters - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-11
Scanning Parameters - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-16
Generic Measurements and Measurements/Calculations - - - - - - - - - - - - - - - - - - - - 13-23
External Inputs and Outputs - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-30
Chapter 14 – Glossary- Abbreviations
Table of Contents
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Voluson™ SWIFT / Voluson SWIFT+ Instructions For Use
5831612-100 Revision 4

Chapter 1
General
This chapter consists of information concerning indications for use and contact information.
Contacting GE - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-2
Manufacturer - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-7
Safety Conformance - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-7
About these Instructions for use - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-7
About this system - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-8
Voluson™ SWIFT / Voluson SWIFT+ Instructions For Use
5831612-100 Revision 4 1-1

The Voluson™ SWIFT / Voluson SWIFT+ 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™ SWIFT / Voluson SWIFT+ 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™ SWIFT / Voluson SWIFT+ is developed and produced by GE Ultrasound
Korea, Ltd. For more Information, please contact:
GE Ultrasound Korea, Ltd.
Telephone +(82) 31-740-6112
Internet http://www.gehealthcare.com
9, Sunhwan-ro 214beon-gil, Jungwon-gu, Seongnam-si, Gyeonggi-do, Republic of Korea
Authorized EU Representative
GE Medical Systems SCS
283 rue de la Miniére
78530 BUC, France
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/transducers
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: [phone]
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.
General
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Voluson™ SWIFT / Voluson SWIFT+ Instructions For Use
5831612-100 Revision 4

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
JAPAN
GE Healthcare Asia Pacific
4-7-127, Asahigaoka
Hino-shi, Tokyo
191-8503 Japan
Tel: [phone]
AUSTRALIA
NEW ZEALAND
GE Healthcare Australia & New Zealand
32 Phillip Street
Parramatta NSW 2150
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 &
LUXENMBURG
GE Medical Systems Ultrasound Eagle Building
Kouterveldstraat 20
1831 DIEGEM
Phone: [phone]
Fax: [phone]
BRAZIL GE HEALTHCARE DO BRASIL COMÉRCIO E SERVIÇOS PARA EQUIPAMENTOS MEDICOS-
HOSPITALARES LTDA.
Av. Magalhães de Castro 4800,
Andar 11 Conj. 111 e 112,
Andar 12 Conj. 121 e 122,
Torre 3 - Cidade Jardim
São Paulo/SP - Brasil
CEP: 05676-120
C.N.P.J.: 00.029.372/0001-40
Phone: [phone] (Capitais e Regiões Metropolitanas)/ 0800 165 799 (Demais Localidades)
Fax: [phone]
CANADA GE Healthcare
Ultrasound Service Engineering
9900 Innovation Drive
Wauwatosa, WI 53226
Phone: [phone]
Customer Answer Center Phone: [phone]
General
Voluson™ SWIFT / Voluson SWIFT+ Instructions For Use
5831612-100 Revision 4 1-3

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
DENMARK GE Medical Systems Ultrasound
Park Alle 295
2605 Brøndby
Phone: [phone]
Fax: [phone]
ESTONIA &
FINLAND
GE Medical Systems
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]
General
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Voluson™ SWIFT / Voluson SWIFT+ Instructions For Use
5831612-100 Revision 4

KOREA Seoul, Republic of Korea
Phone: [phone]
LUXEMBOURG Phone: [phone] 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: [phone]
Fax: [phone]
NETHERLANDS GE Healthcare
De Wel 18 B, 3871 MV Hoevelaken
PO Box 22, 3870 CA Hoevelaken
Phone: [phone]
Fax: [phone]
NORTHERN
IRELAND
GE Healthcare
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
IRELAND
GE Healthcare
Unit F4, Centrepoint Business Park
Oak Drive, Dublin 22
Phone: [phone]
RUSSIA LLC GE Healthcare
Presnenskaya nab., 10
123112 Moscow, Russian Federation
Service center tel: [phone]
Office Phone: [phone]
Office Fax:[phone]
SINGAPORE GE Healthcare Singapure
1 Maritime Square #13-012
HarbourFront Centre
Singapore 099253
Tel: [phone]
General
Voluson™ SWIFT / Voluson SWIFT+ Instructions For Use
5831612-100 Revision 4 1-5

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]
FAKS: [phone]
Esentepe Mah. Harman Sok. 34394 No:8
Sisli-Istanbul
UKRAINE Authorized Representative in Ukraine
Ltd. "GE Ukraine"
st. Shovkovychna 42-44, m. Kyiv, 01004, Ukraine
Tel: [phone]
Fax: [phone]
United Arab
Emirates (U.A.E.)
GE Healthcare Holding
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]
Kazakhstan Authorized representative in Kazakhstan:
General Electric Kazakhstan LLP
Timiryazev St 28V, office 307,
Almaty, 050040
Kazakhstan
T [phone]
General
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Voluson™ SWIFT / Voluson SWIFT+ Instructions For Use
5831612-100 Revision 4

1.2 Manufacturer
GE Ultrasound Korea, Ltd.
9, Sunhwan-ro 214beon-gil, Jungwon-gu, Seongnam-si, Gyeonggi-do, Republic of
Korea
1.3 Safety Conformance
The Voluson™ SWIFT / Voluson SWIFT+ conforms to the following standards and
regulations :
•Classified to ANSIAAMI ES60601-1 2005 R1 2012 Medical Electrical Equipment, Part 1:
General Requirements for Safety by a Nationally Recognized Test Lab
•Certified to CSA CAN/CSA-C22.2 NO. 60601-1 :14 General requirements for safety
•CE Marked to Council Directive 93/42/EEC on Medical Devices
•Conforms to the following standards for safety:
○IEC/EN 60601-1 Medical electrical equipment - Part1 : General requirements for
safety
○EMC Emissions Group 1. Class A device requirements as per Sub clause 5.3 of
CISPR 11
○IEC/EN 60601-1-6 Medical electrical equipment - Part 1-6: General requirements
for basic safety and essential performance - Collateral Standard: Usability
○IEC/EN 60601-2-37 Medical electrical equipment - Part 2-37: Particular
requirements for the safety of ultrasonic medical diagnostic and monitoring
equipment
○IEC/EN 62366 Application of usability engineering to medical devices
○IEC/EN 62366-1 Medical devices-Part1: Application of usability engineering to
medical devices
○IEC/EN 62304 Software Life Cycle Processes
○IEC/EN 62359 Ultrasonic - Field characterization - Test methods for the
determination of thermal and mechanical indices related to medical diagnostic
ultrasonic fields.
○EN/ISO15223-1 Medical devices - Symbols to be used with medical device labels,
labelling and information to be supplied - Part 1: General requirements
○ISO 10993-1 Biological evaluation of medical devices - Part 1 Evaluation and
testing
○WEEE ( Waste Electrical and Electronic Equipment)
○ROHS according to 2011/65/EU
○IEC/EN 60601-1-2 Medical electrical equipment - Part 1-2: General requirements
for basic safety and essential performance - Collateral Standard: Electromagnetic
disturbances - Requirements and tests
1.4 About these Instructions for use
•Read and understand all instructions in the Instructions for Use before attempting to use
the Voluson™ SWIFT / Voluson SWIFT+.
General
Voluson™ SWIFT / Voluson SWIFT+ Instructions For Use
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•These Instructions for Use have to be used in connection with the Voluson™ SWIFT /
Voluson SWIFT+.
•Keep these Instructions for Use with the equipment at all times
•All information contained in the Voluson™ SWIFT / Voluson SWIFT+ Instructions for Use
are 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 Instructions for Use are for illustrative purposes
only and may be different from what is displayed on the screen or device.
1.5 About this system
Intended use
This system is intended for use by a qualified physician or sonographer for ultrasound
evaluation in the following clinical application: Image Acquisition for diagnostic purposes
including measurements on acquired image.
Clinical applications
•Abdomen
•Obstetrics (incl. Fetal Cardio)
•Gynecology
•Cardiology
•Transrectal
•Peripher Vascular
•Pediatrics
•Cephalic
•MSK
•Breast
•Small-parts
Patient population
•Age: all ages (incl. embryos and fetuses)
•Location: worldwide
•Sex: male and female
•Weight: all weight categories
•Height: no limitations
General
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Operator profile
•Qualified physicians or sonographers with at least basic ultrasound knowledge.
•The operator must have read and understood the Instructions for Use.
Contraindications
The Voluson™ SWIFT / Voluson SWIFT+ system is not intended for:
•ophthalmic use or any use where the probe is directly applied to the eye.
•intra-operative use that is defined as introducing probe into a surgical incision or burr
hole.
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
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Indications for Use Statement for US FDA
Voluson™ SWIFT / Voluson SWIFT+ are a general-purpose diagnostic ultrasound system
intended for use by a qualified and trained healthcare professional for ultrasound imaging,
measurement, display and analysis of the human body and fluid. Voluson™ SWIFT / Voluson
SWIFT+ clinical applications include: Fetal/Obstetrics; Abdominal (including renal and GYN/
Pelvic); Pediatric; Small Organ (Breast, Testes, Thyroid, etc.); Neonatal Cephalic; Adult
Cephalic; Cardiac (Adult and Pediatric); Peripheral Vascular (PV); Musculo-skeletal
Conventional and Superficial; Transrectal (including Urology/Prostate) (TR); Transvaginal
(TV).
Mode of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler,
Power Doppler, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode, Elastography and
Combined modes: B/M, B/Color, B/PWD, B/Power/PWD. The Voluson™ SWIFT / Voluson
SWIFT+ are intended to be used in a hospital or medical clinic.
Regulatory remarks
•First CE marked in 2020.
•Federal law restricts this device to sale by or on the order of a physician!
•This machine must be used in compliance with the law. Some jurisdictions restrict certain
uses such as gender determination, contrast imaging, IVF, PUBS or CVS, etc. Please
consider the local laws and regulations.
•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.
The manufacturer, assembler, importer or installer consider themselves responsible regarding
safety, reliability and performance of the equipment under the following conditions:
•Authorized personnel has performed installation and initial start-up of the system.
•Options or new settings have only been added by authorized personnel.
•Authorized personnel has performed modifications or repairs.
•The local electric installation complies with the national regulations.
•The equipment is only used according to the Instructions for Use.
•Paper copy : The EU commission Regulation on electronic instructions for use of medical
devices in the European Union demands, that a paper copy of Instructions for Use can
be ordered at no additional charge. You may therefore, send a request to
[email protected]. This request will be treated within 7 days.
Importer Information
•Türkiye İthalatçısı
GE Medical Systems Türkiye Ltd. Şti.
Esentepe Mah. Harman Sok. No: 8
34394 Şişli İstanbul Türkiye
General
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Chapter 2
Safety
Symobls and Labels - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-2
Information for safe use - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-8
Electric installation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-11
Environmental conditions for operation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-12
Moving the system - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-13
Operation safety - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-13
Cleaning the system - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-15
Maintenance - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-17
Disposal - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-18
Bioeffects and Safety of Ultrasound Scans - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-18
Guidance and manufacturer´s declaration - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-21
Network disclosure - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-25
CyberSecurity Note - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-28
Service Software – Remote Access - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-29
Software Update - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-30
System messages - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-30
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2.1 Symobls and Labels
Description of all symbols and labels used on the system and in the Instructions for Use.
2.1.1 Warning labels used in the Instructions for Use
Symbol Meaning Reference
Warning
Indicates a hazard with a medium level of risk which, if not
avoided, could result in death or serious injury.
General warning sign; IEC 60601-1;
ISO 7010-W001
Caution
Indicates a hazard with a low level of risk which, if not
avoided, could result in minor or moderate injury.
General warning sign IEC 60601-1;
ISO 7010-W001
Warning/Caution: Electric Hazard
Indicates the risk of injury from electric hazards.
General warning sign, adapted to
indicate electrical hazards IEC
60601-1; ISO 3864-1,
Warning/Caution: Biological Hazard
Indicates the risk of disease transmission or infections.
General warning sign, adapted to
indicate biological hazards IEC
60601-1; ISO 3864-1,
Warning/Caution: Explosion Hazard
Indicates the risk of injury from explosion hazards.
General warning sign, adapted to
indicate explosion hazards IEC
60601-1; ISO 3864-1
Warning/Caution: Moving Hazard
Indicates the risk of injury from moving or tipping hazards.
General warning sign, adapted to
indicate moving or tipping hazards IEC
60601-1; ISO 3864-1,
Warning/Caution: Mechanical Hazard
Indicates the risk of injury from mechanical hazards.
General warning sign, adapted to
indicate mechanical hazards IEC
60601-1; ISO 3864-1,
Warning/Caution: Non-ionzing Hazard
Indicates the risk of injury from non-ionizing radiation.
General warning sign, adapted to
indicate non-ionizing radiation hazards
IEC 60601-1; ISO 3864-1,
Warning/Caution: Operating LED
Indicates the risk of injury from light beams entering the eye.
General warning sign, adapted to
indicate light beam hazards; Do not
stare at light source IEC 60601-1; ISO
3864-1; IEC 60417
Safety
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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.
Symbol Meaning Reference
Main power switch ON IEC 60601-1; IEC
60417-5007
Main power switch OFF IEC 60601-1; IEC
60417-5008
USB3.0 USB 3.0 standard
Standby button; Stand-by IEC 60601-1; IEC
60417-5009
Insulated patient applied part (Type BF) IEC 60601-1; IEC
60417-5333
Potential equilibrium connection IEC 60601-1; IEC
60417-5021
This symbol is followed by the manufacturing date of the
device in the form YYYY-MM
ISO 15223-1
This symbol is followed by the name and address of the
manufacturer of the device.
ISO 15223-1
P/N Refers to the Part number of the system. GE crafted symbol
This symbol is followed by the serial number of the device. ISO 15223-1
Batch or lot number ISO 15223-1
Brand and model (reference number) ISO 15223-1
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 other authorized disposal
company to decommission your equipment according to local
regulations. 'Disposal'
on page 2-18
2012/19/EU (WEEE)
Pictogram on Probe Care Card:
Use care when handling ultrasound probes and protect the
probe head from damage.
GE crafted symbol
Safety
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Symbol Meaning Reference
Pictogram on Probe Care Card:
Do not immerse the probe into any liquid beyond the level
specified for that probe. Refer to the Instructions for Use of
the ultrasound system.
GE crafted symbol
Pictogram on Probe Care Card:
Describes precautions necessary to prevent the risk of
disease transmission or infections.
ISO 15223-1
Pictogram on Probe Care Card:
Describes precautions necessary to prevent the risk of injury
through electric hazards. Warning, electricity
IEC 60601-1; ISO
7010-W012
NRTL Classification Label TUV crafted symbol
CE Conformity mark according to Medical Device Directive
93/42/EEC
93/42/EEC
Consult accompanying documents. This symbol advises the
user to consult the accompanying documents.
IEC 60601-1; ISO
7010-M002
Green dot on power cable plug Indicates that the power cable is hospital grade. Grounding
reliability can only be achieved when the equipment is
connected to an equivalent receptacle marked “Hospital only”
or “Hospital grade”. Applicable depending on local regulatory
requirements.
ANSI/UL 498 and CSA
CAN/C22.2 No. 42-99
This indicates the maximum rated power consumption of the
system.
GE crafted symbol
Caution, consult accompanying documents. This symbol
advises the reader to consult the accompanying documents
for important safety-related information such as warnings and
pre-cautions that cannot be presented on the device itself.
IEC 60601-1; ISO
7000-0434A; ISO
15223-1:
No protection against ingress of water (system) IEC 60529
Protected against water immersion - Immersion for 30
minutes at a depth of 1 meter. (ultrasound probes)
IEC 60529
Indicates a USB connector. GE crafted symbol
Indicates a network connector. Computer network. IEC 60417
Earth (ground) connection IEC
60601-1:IEC60417-500
7
Product was refurbished / remanufactured by GE
ULTRASOUND KOREA, LTD.
GE crafted symbol
Safety
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Symbol Meaning Reference
This symbol indicates ESD (electrostatic discharge)
sensitivity of a connector that is not tested as specified in IEC
60601-1-2. Electrostatic discharge can damage the product.
Do not touch exposed connector pins.
IEC 60601-1-2; IEC
60417
This symbol indicates the name and address of authorized
representative in the European Community.
ISO 15223-1
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.
FDA 21 CFR 801
The patient cable protects against the effects of the discharge
of a cardiac defibrillator. Use the patient cables as described
in the chapter 'ECG Preamplifier'
on page 12-7 .
IEC
60601-1:2005+A1:2012
Annex D and ISO
7010-W001
Safety
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This symbol indicates the product contains hazardous materials in excess of the limits
established by the Chinese standard SJ/ T11364-2014 Requirements of concentration
limits for certain restricted substances in electrical and electronic products.
The number in the symbol is the Environment-friendly Use Period (EFUP), which indicates
the period during which the hazardous substances contained in electrical and electronic
products will not leak or mutate under normal operating conditions so that the use of such
electrical and electronic products will not result in any severe environmental pollution, any
bodily injury or damage to any assets. The unit of the period is “Year”.
In order to maintain the declared EFUP, the product shall be operated normally according
to the instructions and environmental conditions as defined in the product Instructions for
Use, and periodic maintenance schedules specified in Product Maintenance Procedures
shall be followed strictly.
Consumables or certain parts may have their own label with an EFUP value less than the
product. Periodic replacement of those consumables or parts to maintain the declared
EFUP shall be done in accordance with the Product Maintenance Procedures. This product
must not be disposed of as unsorted municipal waste, and must be collected separately
and handled properly after decommissioning. (Reference : China Electronic Industry
Standard SJ/T11364-2014)
Component Name Hazardous Substances’ Name
(Pb) (Hg) (Cd) (Cr(VI)) (PBB) (PBDE)
Ultrasound Probes X O O O O O
LCD Monitor X O O O O O
Operator Panel X O O O O O
PWAs X O O O O O
Cables X O O O O O
Power assembly X O O O O O
System Covers X O O O O O
Frame Assembly O O O O O O
Rubber O O O O O O
This table is prepared according to SJ/T 11364.
O: Indicates that hazardous substance contained in all of the homogeneous
materials for this part is below the limit requirement in GB/T 26572.
X: Indicates that hazardous substance contained in at least one of the
homogeneous materials used for this part is above the limit requirement in GB/T
26572 .
•Data listed in the table represents best information available at the time of
publication
•Applications of hazardous substances in this medical device are required to
achieve its intended clinical uses, and/or to provide better protection to human
beings and/or to environment, due to lack of reasonably (economically or
technically) available substitutes.
Symbol Meaning Reference
Tipping danger. Do not lean on the system and take special care
when moving the system.
For transport (especially on inclines >5°) always observe the
instructions described in 'Moving the system'
on page 2-13 .
IEC 60601-1; ISO
7010-P017
Indicates the voltage range the device is built for. The device uses
alternating current.
GE crafted symbol
This indicates the 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.
GE crafted symbol
Safety
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