LOGIQ S7 Expert - Pro User Guide Operating Documentation Rev 2

Regulatory Requirement LOGIQ S7 Expert/Pro complies with regulatory requirements of the following European Directive 93/42/EEC concerning medical devices.

0459 This manual is a reference for the LOGIQ S7 Expert/Pro. It applies to all versions of the R1.x.x software for the LOGIQ S7 Expert/Pro ultrasound system.

GE Healthcare

GE Healthcare P.O. Box 414, Milwaukee, Wisconsin 53201 U.S.A. (Asia, Pacific, Latin America, North America) GE Ultraschall Deutschland GmbH & Co. KG Beethovenstrasse 239 Postfach 11 05 60 D-42655 Solingen GERMANY TEL: 49 212.28.02.208; FAX: 49 212.28.02.431

Revision History Reason for Change DATE (YYYY/MM/DD)

REV

REASON FOR CHANGE

Rev. 1

2012/07/03

Initial release

Rev. 2

2012/07/16

R1.x.x

List of Effective Pages

PAGE NUMBER

REVISION NUMBER

PAGE NUMBER

REVISION NUMBER

Title Page

Rev. 2

Chapter 2

Rev. 2

Revision History

Rev. 2

Chapter 3

Rev. 2

Regulatory Requirements

Rev. 2

Chapter 4

Rev. 2

Table of Contents

Rev. 2

Index

Rev. 2

Chapter 1

Rev. 2

Please verify that you are using the latest revision of this document. Information pertaining to this document is maintained on ePDM (GE Healthcare electronic Product Data Management). If you need to know the latest revision, contact your distributor, local GE Sales Representative or in the USA call the GE Ultrasound Clinical Answer Center at 1 800 682 5327 or 1 262 524 5698.

LOGIQ S7 Expert/Pro – User Guide Direction 5453159-100 Rev. 2

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LOGIQ S7 Expert/Pro – User Guide Direction 5453159-100 Rev. 2

Regulatory Requirements

Conformance Standards The following classifications are in accordance with the IEC/ EN 60601-1:6.8.1: •

According to 93/42/EEC Medical Device Directive, this is Class IIa Medical Device.

•

According to IEC/EN 60601-1, •

•

According to CISPR 11, •

•

Equipment is Class I, Type BF or CF Applied Parts. Equipment is Group 1, Class B ISM Equipment.

According to IEC 60529, •

The footswitch rate IPx8 is suitable for use in surgical rooms.

•

Probe head (immersible portion) and cable are IPX7 Probe connector is not waterproof.

This product complies with the regulatory requirement of the following: •

Council Directive 93/42/EEC concerning medical devices: the CE label affixed to the product testifies compliance to the Directive. The location of the CE marking is shown in the Safety chapter of this manual. European registered place of business: GE Medical Systems Information Technologies GmbH Munzinger Strasse 5 D-79111 Freiburg, Germany Tel: +49 (0) 761 45 43 -0; Fax: +49 (0) 761 45 43 -233

LOGIQ S7 Expert/Pro – User Guide Direction 5453159-100 Rev. 2

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Conformance Standards (continued) •

•

International Electrotechnical Commission (IEC). •

IEC/EN 60601-1 Medical Electrical Eqiupment, Part 1 General Requirements for Safety.

•

IEC/EN 60601-1-1 Safety requirements for medical electrical systems.

•

IEC/EN 60601-1-2 Electromagnetic compatibility Requirements and tests.

•

IEC/EN 60601-1-4 Programmable electrical medical systems.

•

IEC 60601-1-6 (Usability), EN 1041 (Information supplied with medical devices)

•

IEC 60601-2-37 Medical electrical equipment. Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment.

•

IEC 61157 Declaration of acoustic output parameters.

International Organization of Standards (ISO) •

•

Underwriters’ Laboratories, Inc. (UL), an independent testing laboratory. •

•

UL 60601-1 Medical Electrical Equipment, Part 1 General Requirements for Safety.

Canadian Standards Association (CSA). •

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ISO 10993-1 Biological evaluation of medical devices.

CSA 22.2, 601.1 Medical Electrical Equipment, Part 1 General Requirements for Safety.

•

NEMA/AIUM Acoustic Output Display Standard (NEMA UD-3).

•

Medical Device Good Manufacturing Practice Manual issued by the FDA (Food and Drug Administration, Department of Health, USA).

LOGIQ S7 Expert/Pro – User Guide Direction 5453159-100 Rev. 2

Certifications •

General Electric Medical Systems is ISO 9001 and ISO 13485 certified.

Original Documentation •

The original document was written in English.

Country Specific Approval CAUTION

The following optional features ARE NOT available in the USA and its territories: •

Elastography Quantification

•

Contrast Enhanced Ultrasound

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LOGIQ S7 Expert/Pro – User Guide Direction 5453159-100 Rev. 2

Table of Contents

Conformance Standards - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-3 Certifications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-5 Original Documentation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-5 Country Specific Approval - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-5

Table of Contents Chapter 1 - Getting Started Console Overview Attention - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-2 Indications for Use - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-3 Contraindication - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-4 Prescription Device - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-4 Console Graphics - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-5 Peripheral/Accessory Connection- - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-6 Control Panel Map - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-8 Control panel adjustment- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-10 Touch Panel- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-12 Monitor Display- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-14

Site Requirements Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-17 Before the system arrives - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-18 Environmental Requirements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-19

Moving the System Before moving the system - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-20 Wheels - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-22 Moving the System - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-23

System Start-Up Power On- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-25 Power Off- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-26 Crash Recovery Instructions - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-28 Circuit Breaker - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-29

Probes Connecting the Probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-30 Cable Handling - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-32 Activating the Probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-32 Deactivating the Probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-33 Disconnecting the Probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-33 Probe Description - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-34

Beginning an Exam Scanning a New Patient - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-36

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Patient Screen - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-39

Chapter 2 - Performing an Exam Optimizing the Image B-Mode Controls- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-2 M-Mode Controls - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-5 Color Flow Mode Controls - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-6 Doppler Mode Controls - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-8 3D Mode - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-10 Other Controls - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-11

Measurement and Analysis Location of Measurement Controls - - - - - - - - - - - - - - - - - - - - - - - - - - 2-17 B-Mode Measurements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-18 Doppler Mode Measurements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-26 M-Mode Measurements- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-30 Viewing and Editing Worksheets - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-32 Clinical Measurement Accuracy - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-37

Chapter 3 - After the Exam is Over Probe Overview Probe handling and infection control - - - - - - - - - - - - - - - - - - - - - - - - - - 3-2 Inspecting probes - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-3 Cleaning and disinfecting probes - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-4 Coupling gels - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-11 Biopsy Special Concerns- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-12

System Presets Foreign Language Keyboard Setup - - - - - - - - - - - - - - - - - - - - - - - - - 3-15 Keyboard Setup Procedure for Russian and Greek - - - - - - - - - - - - - - 3-17

Data Backup EZBackup and EZMove- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-23

Configuring Connectivity Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-37 Connectivity Functions - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-38 Anti-Virus Software Note - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-39

Electronic Documentation Accessing Documentation Via a PC - - - - - - - - - - - - - - - - - - - - - - - - - 3-40 Accessing Documentation on the Ultrasound Scanner Via the media- - 3-41 Using Online Help Via F1 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-42

System Care and Maintenance Expected Service Life Description - - - - - - - - - - - - - - - - - - - - - - - - - - 3-43 Inspecting the System - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-44 Cleaning the system - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-46 Cleaning the air filter - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-49 Prevention of static electricity interference- - - - - - - - - - - - - - - - - - - - - 3-50

Contact Information Contacting GE Healthcare Ultrasound - - - - - - - - - - - - - - - - - - - - - - - 3-52 Manufacturer - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-57

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LOGIQ S7 Expert/Pro – User Guide Direction 5453159-100 Rev. 1

Chapter 4 - Safety Owner Responsibility Notice against user modification- - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-3

Safety Precautions Precaution Levels - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-4 Hazard Symbols - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-5 Patient Safety- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-7 Equipment and Personnel Safety - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-10 Classifications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-14 EMC (Electromagnetic Compatibility) - - - - - - - - - - - - - - - - - - - - - - - - 4-15 Patient Environmental Devices- - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-27 Acoustic Output - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-29

Device Labels Label Icon Description- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-33 Label location - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-38 Label on the packing box- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-39

Index

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LOGIQ S7 Expert/Pro – User Guide Direction 5453159-100 Rev. 1

Chapter 1 Getting Started Console Overview, Moving the System, System Start-up, Probes and Beginning an Exam

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Getting Started

Console Overview

Attention This manual contains necessary and sufficient information to operate the system safely. Advanced equipment training may be provided by a factory trained Applications Specialist for the agreed-upon time period. Read and understand all instructions in this manual before attempting to use the LOGIQ S7 Expert/Pro system. Keep this manual with the equipment at all times. Periodically review the procedures for operation and safety precautions. Disregarding information on safety is considered abnormal use. Not all features or products described in this document may be available or cleared for sale in all markets. Please contact your local GE Healthcare Ultrasound representative to get the latest information.

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NOTE:

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

NOTE:

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

LOGIQ S7 Expert/Pro – User Guide Direction 5453159-100 Rev. 2

Console Overview Indications for Use The LOGIQ S7 Expert/Pro is intended for use by a qualified physician for ultrasound evaluation. Frequency of Use

Daily (Typically 8 hours)

Operator Profile

•

Qualified and trained physicians or sonographers with at least basic ultrasound knowledge.

•

The operator must have read and understood the user manual.

Clinincal Applications

Specific clinical applications and exam types include: •

Abdominal

•

Obstetrical

•

Gynecological

•

Breast

•

Small Parts

•

Vascular/Intraoperative/Peripheral

•

Transcranial

•

Pediatric

•

Neonatal

•

Musculoskeletal

•

Urological

•

Cardiac

•

Interventional

Image Acquisition is for diagnostic purposes, including measurements on acquired images.

CAUTION

This machine should be used in compliance with law. Some jurisdictions restrict certain uses, such as gender determination.

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Getting Started Contraindication The LOGIQ S7 Expert/Pro ultrasound system is not intended for ophthalmic use or any use causing the acoustic beam to pass through the eye.

Prescription Device CAUTION: United States law restricts this device to sale or use by, or on the order of a physician.

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LOGIQ S7 Expert/Pro – User Guide Direction 5453159-100 Rev. 2

Console Overview Console Graphics

Figure 1-1.

1. 2. 3. 4. 5. 6. 7.

LOGIQ S7 Expert/Pro System (mid cabinet type example)

LCD Monitor Touch panel USB port Probe holder A/N keyboard Control panel swivel button Control panel up/down button

8. Probe holder (Option) 9. DVD Drive 10. BW printer 11. Color printer or Drawer 12. Foot rest 13. CW pencil probe port 14. Side tray (Option)

LOGIQ S7 Expert/Pro – User Guide Direction 5453159-100 Rev. 2

15. Probe port - 4 active probe ports 16. Audio speaker 17. Gel warmer 18. ECG connector 19. Articulating arm 20. External I/O panel

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Getting Started Peripheral/Accessory Connection Peripheral/Accessory Connector Panel LOGIQ S7 Expert/Pro peripherals and accessories can be properly connected using the rear connector panel.

CAUTION

For compatiblity reasons, use only GE approved peripherals or accessories. DO NOT connect any probes or accessories which are not approved for use by GE.

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CAUTION

The connection of equipment or transmission networks other than as specified in these instructions can result in electric shock hazard. Alternate connections will require verification of compatibility and conformity to IEC/EN 60601-1-1 by the installer.

CAUTION

Do not touch the conducting parts of the USB or Ethernet cables when connecting equipment to the unit.

CAUTION

When using peripheral device, observe all warnings and cautions given in peripheral operator manuals.

LOGIQ S7 Expert/Pro – User Guide Direction 5453159-100 Rev. 2

Console Overview Peripheral/Accessory Connector Panel (continued)

Figure 1-2.

Peripheral/Accessory Connector Panel

1.

USB Port

USB 1.1 (Bacl) 2.0 (Front)

2.

HDMI connector

HDMI connector for external monitor

3.

Ethernet

LAN for InSite, DICOM, Network storage Connection (RJ45)

4.

Audio

Audio Line Out (3.5mm pin jack)

5.

Circuit breaker

15A

6.

AC Inlet

100-120V/200-240V

LOGIQ S7 Expert/Pro – User Guide Direction 5453159-100 Rev. 2

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Getting Started Wired Footswitch (Option) You can attach this Footswitch to the system by connecting it to any USB port on the system.

Figure 1-3.

3-button Footswitch

This is a 3-pedal Footswitch. You can configure its functionality via the Utility -> Applications -> Footswitch parameters.

CAUTION

When using the Footswitch, DO NOT hold down the footswitch pedal. Press and release the Footswitch pedal. Pushing and holding down the pedal behaves the same way as pushing and holding down a key on the keyboard.

Control Panel Map Controls are grouped together by function for ease of use. See the callout for this figure onthe following page.

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LOGIQ S7 Expert/Pro – User Guide Direction 5453159-100 Rev. 2