LOGIQ e User Guide Rev 3

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

This manual is a reference for the LOGIQ e. It applies to all versions of the R5.2.x and R6.x.x software for the LOGIQ e ultrasound system.

GE Healthcare

GE Healthcare: Telex 3797371 P.O. Box 414, Milwaukee, Wisconsin 53201 U.S.A. (Asia, Pacific, Latin America, North America) GE Ultraschall: TEL: 49 212.28.02.208 Deutschland GmbH & Co. KG: FAX: 49 212.28.02.431 Beethovenstrasse 239 Postfach 11 05 60 D-42655 Solingen GERMANY

Revision History Reason for Change REV

DATE (YYYY/MM/DD)

REASON FOR CHANGE

Rev. 1

2008/09/17

Initial release

Rev. 2

2010/04/08

Update for software update and adding probes

Rev. 3

2010/11/29

Update to add Factory Site and CKD Rating Plate

List of Effected Pages REVISION NUMBER

PAGE NUMBER

PAGE NUMBER

REVISION NUMBER

Title Page

Rev. 3

Chapter 3

Rev. 3

Revision History

Rev. 3

Chapter 4

Rev. 3

Regulatory Requirements

Rev. 3

Chapter 5

Rev. 3

Table of Contents

Rev. 3

Chapter 6

Rev. 3

Chapter 1

Rev. 3

Chapter 7

Rev. 3

Chapter 2

Rev. 3

Index

Rev. 3

Please verify that you are using the latest revision of this document. Information pertaining to this document is maintained on MyWorkshop/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 e User Guide Direction 5314626-100 Rev. 3

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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,

•

•

•

Equipment is Class I, Type B with BF or CF Applied Parts.

•

Docking Cart console is Class I.

According to CISPR 11, •

Equipment is Group 1, Class A ISM Equipment.

•

Docking Cart is Group 1, Class A ISM Equipment.

According to IEC 60529, the footswitch rate is IPx1 (FSU2001) or IPx8 (MKF 2-MED GP26, FSU-1000) .

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. Authorized EU Representative European registered place of business: GE Medical Systems Information Technologies GmbH (GEMS IT GmbH) Munzinger Strasse 5, D-79111 Freiburg, GERMANY Tel: +49 761 45 43 -0; Fax: +49 761 45 43 -233

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LOGIQ e User Guide Direction 5314626-100 Rev. 3

Conformance Standards (continued) •

•

International Electrotechnical Commission (IEC). •

IEC/EN 60601-1 Medical Electrical Equipment, 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/EN 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. •

•

ISO 10993-1 Biological evaluation of medical devices.

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

Canadian Standards Association (CSA). •

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

•

NEMA/AIUM Acoustic Output Display Standard (NEMA UD3).

•

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

•

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

Certifications

Original Documentation •

The original document was written in English.

LOGIQ e User Guide Direction 5314626-100 Rev. 3

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Country Specific Approval •

JAPAN MHLW Certified Number: 218ABBZX00060000

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LOGIQ e User Guide Direction 5314626-100 Rev. 3

Table of Contents

Conformance Standards - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-2 Certifications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-3 Original Documentation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-3 Country Specific Approval - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-4

Table of Contents Chapter 1 - Getting Started Console Overview Application Specific Systems - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-2 Indications for Use - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-3 Contraindication - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-3 Prescription Device - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-3 Important Notices - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-4 Console graphics - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-6

Moving the System Before moving the system - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-17 When moving the system - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-17

System Start-Up Power On - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-18 Power Off- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-19

Probes Connecting the Probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-20 Cable Handling - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-22 Disconnecting the Probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-22 Applications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-23 Features - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-24

Beginning an Exam Scanning a New Patient - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-25 Patient Screen - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-27

Chapter 2 - Performing an Exam Optimizing the Image B-Mode Controls- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-2 M-Mode Controls - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-4 Color Flow Mode Controls - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-5 Doppler Mode Controls - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-7 Other Controls - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-9

Measurement and Analysis B-Mode Measurements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-12 Doppler Mode Measurements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-18 M-Mode Measurements- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-22

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Viewing and Editing Worksheets - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-24

Chapter 3 - After the Exam is Over Probe Overview Probe handling and infection control - - - - - - - - - - - - - - - - - - - - - - - - - - 3-2 Endocavitary Probe Handling Precautions- - - - - - - - - - - - - - - - - - - - - - 3-3 Probe Cleaning Process - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-4 Coupling gels - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-10

System Presets Foreign Language Keyboard Setup - - - - - - - - - - - - - - - - - - - - - - - - - 3-11

Backup and Restore Backup and restore strategy: patient data - - - - - - - - - - - - - - - - - - - - - 3-16 Restore procedure: patient data - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-17 Backup procedure: user-defined configurations - - - - - - - - - - - - - - - - - 3-18 Restore procedure: user-defined configurations- - - - - - - - - - - - - - - - - 3-19

Configuring Connectivity Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-20 Connectivity Functions - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-21

Electronic Documentation Accessing Documentation Via a PC - - - - - - - - - - - - - - - - - - - - - - - - - 3-22 Using Online Help Via F1 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-23

Contact Information Contacting GE Healthcare Ultrasound - - - - - - - - - - - - - - - - - - - - - - - 3-24 Manufacturer - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-28 Factory Sites - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-28

System Care and Maintenance Inspecting the System - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-29 Weekly Maintenance- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-30 Other Maintenance - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-33 Supplies/Accessories - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-33

Chapter 4 - Safety Safety Precautions Precaution Levels - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-2 Hazard Symbols - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-3 Patient Safety- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-5 Equipment and Personnel Safety - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-8 Device Labels- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-14 EMC (Electromagnetic Compatibility) - - - - - - - - - - - - - - - - - - - - - - - - 4-19 Patient Environmental Devices- - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-28 Acoustic Output - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-30 Warning Label Locations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-33

Chapter 5 - Emergency Department (ED) Beginning an Exam Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-2 Starting a New Patient- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-3

Optimizing the Image B-Mode - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-4 M-Mode - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-6

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LOGIQ e User Guide Direction 5314626-100 Rev. 3

Color Flow (CF) Mode - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-7 Power Doppler Imaging (PDI) Mode - - - - - - - - - - - - - - - - - - - - - - - - - - 5-9 M Color Flow Mode- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-11 Pulsed Wave (PW) Doppler Mode - - - - - - - - - - - - - - - - - - - - - - - - - - 5-13

Chapter 6 - Nerve Block Beginning an Exam Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-2 Starting a New Patient- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-3 Selecting an Application Preset and a Probe - - - - - - - - - - - - - - - - - - - - 6-4

Optimizing the Image B-Mode - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-5 Color Flow (CF) Mode - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-7 Power Doppler Imaging (PDI) Mode - - - - - - - - - - - - - - - - - - - - - - - - - - 6-9 Pulsed Wave (PW) Doppler Mode - - - - - - - - - - - - - - - - - - - - - - - - - - 6-11

Chapter 7 - Using Touch Screen Beginning an Exam Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-2 Touch Screen Display - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-3 Starting a New Patient- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-4 Selecting an Application Preset and a Probe - - - - - - - - - - - - - - - - - - - - 7-4

Optimizing the Image B-Mode - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-5 M-Mode - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-7 Color Flow (CF) Mode - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-8 Power Doppler Imaging (PDI) Mode - - - - - - - - - - - - - - - - - - - - - - - - - - 7-9 Pulsed Wave (PW) Doppler Mode - - - - - - - - - - - - - - - - - - - - - - - - - - 7-10

Measurement Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-11 List of General Measurements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-11 General Instructions - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-12

Comment General Instructions - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-13

Using CINE Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-15 Activate CINE- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-15 CINE mode monitor display - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-16

Index

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LOGIQ e User Guide Direction 5314626-100 Rev. 3

Chapter 1 Getting Started Console Overview, Moving the System, System Startup, Probes and Beginning an Exam

LOGIQ e User Guide Direction 5314626-100 Rev. 3

1-1

Getting Started

Console Overview

Application Specific Systems For information on using the LOGIQ e system optimized for Emergency Department use, refer to Chapter 5. For information on using the LOGIQ e system optimized for Nerve Block Guidance, refer to Chapter 6.

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LOGIQ e User Guide Direction 5314626-100 Rev. 3

Console Overview Indications for Use The LOGIQ e is intended for use by a qualified physician for ultrasound evaluation. Specific clinical applications and exam types include:

CAUTION

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Fetal/Obstetrics

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Abdominal (including GYN)

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Pediatric

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Small Organ (including breast, testes, thyroid)

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Neonatal Cephalic

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Adult Cephalic

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Cardiac (adult and pediatric)

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Peripheral Vascular

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Intraoperative (abdominal, thoracic and peripheral)

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Thoracic/Pleural (fluid/motion detection)

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Musculo-skeletal Superficial

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Musculo-skeletal Conventional

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Urology (including prostate)

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Transrectal

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Transvaginal

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Transesophageal

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

Contraindication The LOGIQ e 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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Getting Started Important Notices Do not attempt to install the system alone. General Electric, Affiliate, or Distributor Field Engineers and Application Specialists will install and setup the system. See ‘Contact Information’ on page 3-24 for more information. NOTICE

This medical equipment is approved, in terms of the prevention of radio wave interference, to be used in hospitals, clinics and other institutions which are environmentally qualified. The use of this equipment in an inappropriate environment may cause some electronic interference to radios and televisions around the equipment. Ensure that the following is provided for the new system: •

A separate power outlet with a 6 amp circuit breaker for 220240 VAC or a 10 amp circuit breaker for 100-120 VAC.

•

Take precautions to ensure that the console is protected from electromagnetic interference. Precautions include:

WARNING

•

Operate the console at least 15 feet away from motors, typewriters, elevators, and other sources of strong electromagnetic radiation.

•

Operation in an enclosed area (wood, plaster or concrete walls, floors and ceilings) helps prevent electromagnetic interference.

•

Special shielding may be required if the console is to be operated in the vicinity of radio broadcast equipment.

To avoid risk of fire, the system power must be supplied from a separate, properly rated outlet. Under no circumstances should the AC power plug be altered, changed, or adapted to a configuration rated less than specified. Never use an extension cord or adapter plug. To help assure grounding reliability, connect to a “hospital grade” or “hospital only” grounded power outlet.

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LOGIQ e User Guide Direction 5314626-100 Rev. 3

Console Overview Important Notices (continued) Table 1-1: AC DC Type

Example Plug and Outlet Configurations

Specification

AC DC Type

Specification

220-240 VAC, 2.5A (China)

220-240 VAC, 2.5A (Switzerland)

220-240 VAC, 2.5A (India)

220-240 VAC, 2.5A (U.K.)

220-240 VAC, 2.5A (Argentina)

100-120 VAC, 2.5A (USA)

220-240 VAC, 2.5A (Europe)

220-240 VAC, 2.5A (Israel)

100-120 VAC, 2.5A (Japan)

220-240 VAC, 2.5A (Australia)

LOGIQ e User Guide Direction 5314626-100 Rev. 3

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Getting Started Console graphics The following are illustrations of the console:

Figure 1-1.

LOGIQ e System (opened view)

1. Handle 2. Soft Menu (use same as menu key) 3. LCD 4. Alphanumeric keys 5. Control Panel

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LOGIQ e User Guide Direction 5314626-100 Rev. 3

Console Overview Console graphics (continued)

Figure 1-2. LOGIQ e System (side views)

CAUTION

Do not push objects into air vents and openings of LOGIQ e. Doing so can cause fire or electric shock by shorting out interior components.

CAUTION

For compatibility reasons, use only GE approved probes, peripherals or accessories. DO NOT connect any probes or accessories without approval by GE.

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Getting Started Battery The lithium ion battery provides power when an AC power source is not available. A battery in the battery bay is standard with the LOGIQ e. Lithium ion batteries last longer than conventional batteries and do not require replacement as often. You can expect one hour of battery life while scanning with a single fully charged battery. The lithium ion technology used in your system’s battery is significantly less hazardous to the environment than the lithium metal technology used in some other batteries (such as watch batteries). Used batteries should not be placed with common household waste products. Contact local authorities for the location of a chemical waste collection program nearest you. NOTE:

WARNING

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The battery is designed to work with LOGIQ e systems only. Only use the batteries authorized by GE. •

The battery has a safety device. Do not disassemble or alter the battery.

•

Charge the batteries only when the ambient temperature is between 0 and 40 degrees C (32 and 104 degrees F) and discharge the batteries between 0 and 40 degrees C (32 and 104 degrees F).

•

Do not short-circuit the battery by directly connecting the negative terminals with metal objects.

•

Do not heat the battery or discard it in a fire.

•

Do not expose the battery to temperature over 50 degrees C (122 degrees F). Keep it away from fire and other heat sources.

•

Do not charge the battery near a heat source, such as a fire or heater.

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Do not leave the battery in direct sunlight.

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Do not pierce the battery with a sharp object, hit it, or step on it.

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Do not use a damaged battery.

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Do not solder a battery.

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Do not connect the battery to an electrical power outlet.

LOGIQ e User Guide Direction 5314626-100 Rev. 3

Console Overview Battery (continued)

WARNING

If the LOGIQ e is not being used on a monthly basis, the battery needs to be removed during the lengthy non-use period.

CAUTION

To avoid the battery bursting, igniting, or fumes from the battery causing equipment damage, observe the following precautions: •

Do not immerse the battery in water or allow it to get wet.

•

Do not put the battery into a microwave oven or pressurized container.

•

If the battery leaks or emits an odor, remove it from all possible flammable sources.

•

If the battery emits an odor or heat, is deformed or discolored, or in a way appears abnormal during use, recharging or storage, immediately remove it and stop using it. If you have any questions about the battery, consult GE or your local representative.

•

Short term (less than one month) storage of battery pack: •

LOGIQ e User Guide Direction 5314626-100 Rev. 3

Store the battery in a temperature range between 0 degrees C (32 degrees F) and 50 degrees C (122 degrees F).

1-9

Getting Started Battery (continued)

CAUTION

•

Long term (3 months or more) storage of battery pack: •

Store the battery in a temperature range between -20 degrees C (-4 degrees F) and 45 degrees C (113 degrees F)

•

Upon receipt of the LOGIQ e and before first time usage, it is highly recommended that the customer performs one full discharge/charge cycle. NOTE: A full discharge/charge cycle means the system is turned on using battery power until the battery loses its charge completely and the system shuts down. Plug the LOGIQ e in until the battery is fully charged as indicated by a green LCD light. If the battery has not been used for >2 months, the customer is recommended to perform one full discharge/charge cycle. It is also recommended to store the battery in a shady and cool area with FCC (full current capacity).

•

One Full Discharge/Charge Cycle Process: 1. Full discharge of battery to let the LOGIQ e automatically shut down. 2. Charge the LOGIQ e to 100% FCC (full current capacity). 3. Discharge of LOGIQ e for complete shut down (takes one hour for discharge).

•

•

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When storing packs for more than 6 months, charge the pack at least once during the 6 month timeframe to prevent leakage and deterioration in performance.

Use only GE recognized batteries.

LOGIQ e User Guide Direction 5314626-100 Rev. 3