GE Healthcare LOGIQ E9 R3.x.x ultrasound system User Guide
Below you will find brief information for ultrasound system LOGIQ E9 R3.x.x. The LOGIQ E9 ultrasound system is intended for use by a qualified physician for ultrasound evaluation. Specific clinical applications and exam types include: fetal/obstetrics, abdominal, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, peripheral vascular, musculo-skeletal, urology, transrectal, transvaginal, transesophageal and intraoperative. The system is also equipped with a variety of features to help optimize the image and perform accurate measurements.
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GE Healthcare Technical Publications Direction 5389561-100 English Rev. 1 0459 LOGIQ E9 User Guide R3.x.x Operating Documentation Copyright 2010 By General Electric Co. Regulatory Requirement LOGIQ E9 complies with regulatory requirements of the following European Directive 93/42/EEC concerning medical devices. 0459 This manual is a reference for the LOGIQ E9. It applies to all versions of the R3.x.x software for the LOGIQ E9 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 DATE (YYYY/MM/DD) REV Rev. 1 2010/12/15 REASON FOR CHANGE R3.x.x List of Effective Pages PAGE NUMBER REVISION NUMBER PAGE NUMBER REVISION NUMBER Title Page Rev. 1 Chapter 2 Rev. 1 Revision History Rev. 1 Chapter 3 Rev. 1 Regulatory Requirements Rev. 1 Chapter 4 Rev. 1 Table of Contents Rev. 1 Index Rev. 1 Chapter 1 Rev. 1 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 E9 – User Guide Direction 5389561-100 English Rev. 1 i-1 This page intentionally left blank. i-2 LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 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. According to CISPR 11, • Equipment is Group 1, Class A ISM Equipment. 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 3, D-79111 Freiburg, GERMANY Tel: +49 761 45 43 -0; Fax: +49 761 45 43 -233 LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 i-3 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. 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). • i-4 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 E9 – User Guide Direction 5389561-100 English Rev. 1 Certifications • General Electric Medical Systems is ISO 9001 and ISO 13485 certified. Original Documentation • The original document was written in English. Country Specific Approval • JAPAN MHLW Certified Number: 220ABBZX00177000 • KOREA KFDA License 09-180 LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 i-5 i-6 LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 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 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Prescription Device - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Indications for Use - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Contraindication - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Important Notices - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Console Graphics - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-2 1-2 1-3 1-3 1-4 1-6 Moving the System Before moving the system - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - When moving the system - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Operator Panel Movement Controls - - - - - - - - - - - - - - - - - - - - - - - - Setting the front wheels lock - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-16 1-18 1-19 1-21 System Start-Up Power On- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Sleep Mode - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Power Off- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Circuit breaker - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-22 1-23 1-24 1-26 Probes Introduction - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Connecting the Probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Cable Handling - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Activating the Probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Disconnecting the Probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - LOGIQ E9 Applications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - LOGIQ E9 Features- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-27 1-28 1-29 1-29 1-30 1-31 1-32 Beginning an Exam Scanning a New Patient - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-34 Patient Screen - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-36 Chapter 2 — Performing an Exam Optimizing the Image B-Mode Controls- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-2 Color Flow Mode Controls - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-5 M-Mode Controls - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-7 LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 i-7 M Color Flow Mode- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-7 Doppler Mode Controls - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-8 3D Mode - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-10 Other Controls - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-11 Measurement and Analysis Location of Measurement Controls - - - - - - - - - - - - - - - - - - - - - - - - - B-Mode Measurements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Doppler Mode Measurements - - - - - - - - - - - - - - - - - - - - - - - - - - - - M-Mode Measurements- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Viewing and Editing Worksheets - - - - - - - - - - - - - - - - - - - - - - - - - - Clinical Measurement Accuracy - - - - - - - - - - - - - - - - - - - - - - - - - - - Setting up the Off-Line Paper Printer - - - - - - - - - - - - - - - - - - - - - - - - 2-16 2-17 2-24 2-27 2-29 2-34 2-36 Chapter 3 — After the Exam is Over Probe Overview Probe Naming Conventions - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-2 Probe handling and infection control - - - - - - - - - - - - - - - - - - - - - - - - - - 3-3 Endocavitary Probe Handling Precautions- - - - - - - - - - - - - - - - - - - - - - 3-4 Probe Cleaning Process - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-5 Coupling gels - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-13 Biopsy Special Concerns- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-15 Displaying the Guidezone - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-16 Surgery/Intra-operative Use - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-17 System Presets Foreign Language Keyboard Setup - - - - - - - - - - - - - - - - - - - - - - - - - 3-18 Data Backup EZBackup and EZMove- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Backup procedure: user-defined configurations - - - - - - - - - - - - - - - - Restore procedure: patient data - - - - - - - - - - - - - - - - - - - - - - - - - - - Restore procedure: user-defined configurations- - - - - - - - - - - - - - - - - 3-24 3-31 3-32 3-33 Configuring Connectivity Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-34 Connectivity Functions - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-35 Anti-Virus Software Note - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-36 Electronic Documentation Accessing Documentation Via a PC - - - - - - - - - - - - - - - - - - - - - - - - - 3-37 Accessing Documentation on the Ultrasound Scanner Via the media- - 3-38 Using Online Help Via F1 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-39 Contact Information Contacting GE Healthcare Ultrasound - - - - - - - - - - - - - - - - - - - - - - - 3-40 Manufacturer - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-45 System Care and Maintenance Expected Service Life Description - - - - - - - - - - - - - - - - - - - - - - - - - Inspecting the System - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Weekly Maintenance- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - System Cabinet - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Touch Panel- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Operator Controls - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-8 3-46 3-47 3-48 3-48 3-48 3-49 LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 LCD Monitor - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-51 Other Maintenance - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-52 Supplies/Accessories - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-55 Chapter 4 — Safety Safety Precautions Precaution Levels - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-2 Hazard Symbols - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-3 Patient Safety- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-5 Equipment and Personnel Safety - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-9 Device Labels- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-15 EMC (Electromagnetic Compatibility) - - - - - - - - - - - - - - - - - - - - - - - - 4-23 Patient Environmental Devices- - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-34 Acoustic Output - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-36 Warning Label Locations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-39 Index LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 i-9 i-10 LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 Chapter 1 Getting Started Console Overview, Moving the System, System Start-up, Probes and Beginning an Exam LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 1-1 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 E9 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. Prescription Device CAUTION: United States law restricts this device to sale or use by, or on the order of a physician. 1-2 LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 Console Overview Indications for Use The LOGIQ E9 is intended for use by a qualified physician for ultrasound evaluation. Specific clinical applications and exam types include: CAUTION • Fetal/Obstetrics • Abdominal (includes renal, GYN/Pelvic) • Pediatric • Small Organ (breast, testes, thyroid) • Neonatal Cephalic • Adult Cephalic • Cardiac (adult and pediatric) • Peripheral Vascular • Musculo-skeletal Conventional and Superficial • Urology (including prostate) • Transrectal • Transvaginal • Transesophageal • Intraoperative (abdominal, thoracic, vascular and neurosurgical) This machine should be used in compliance with law. Some jurisdictions restrict certain uses, such as gender determination. Contraindication The LOGIQ E9 ultrasound system is not intended for ophthalmic use or any use causing the acoustic beam to pass through the eye. NOTE: Only qualified physicians or sonographers should perform ultrasound scanning on human subjects for medical diagnostic reasons. Request training, if needed. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 1-3 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 3-40 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 20 amp circuit breaker for 120 VAC for 120V area, 7.5 amp circuit breaker for 220-240VAC for 220/240V area or 15 amp circuit breaker for 100 VAC for Japan. • Take precautions to ensure that the console is protected from electromagnetic interference. Precautions include: 1-4 • 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. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 Console Overview Important Notices (continued) WARNING 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. CAUTION Use caution to ensure that the power cable does not disconnect during system use. If the system is accidentally unplugged, data may be lost. CAUTION To avoid leakage current above safety limits as prescribed by IEC 60601-1 and to ensure continuity of protective earth. DO NOT connect LOGIQ E9 and mains-operated accessories to a single or multiple socket extension cord or power strip. Figure 1-1. 1. Example Plug and Outlet Configurations 100-120 VAC, 1200 VA Plug and Outlet Configuration 2. 220-240 VAC, 1200 VA Plug and Outlet Configuration LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 1-5 Getting Started Console Graphics The following are illustrations of the console: Figure 1-2. LOGIQ E9 System (right and left side views) 1. LCD 2. Gel Holder / Specialty Probe Holder 3. Operator Panel, Probe Holders with Cable Management 4. Brake Release / Up/Down Controls CAUTION 5. Peripherals (Black/White Printer and CD/DVD Drive) and Network Activity/Speed (Green=1 Gigabyte and Yellow=100 Mb) and Hard Disk Drive Indicator 6. Probe Connectors 7. Brakes For compatiblity reasons, use only GE approved probes, peripherals or accessories. DO NOT connect any probes or accessories without approval by GE. 1-6 LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 Console Overview Console Graphics (continued) Figure 1-3. LOGIQ E9 System (front and back views) 1. Power On/Off; Operator Panel USB Ports 2. Brake and Up/Down Controls 3. Probe Cable Management Hooks (underneath Operator Panel) 4. Black/White Printer 5. CD/DVD Drive 6. Network and Hard Disk Drive Indicators 7. Patient I/O (ECG, CW Probe Connector) 8. Volume Navigation Connectors LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 9. 10. 11. 12. 13. 14. Probe Connectors Brake Pedal Rear Handle Power Cord Hooks Op Panel Up/Down Manual Release Level Access to Peripheral USB Ports, Audio In/Out, DVI Connector, and Ethernet Connectors 15. Breaker and Power Cord 16. Back Filter 1-7 Getting Started USB Ports CAUTION Peripheral devices that use their own AC power source cannot be attached to the system. Operator Panel The two Operator Panel USB Ports SHOULD ONLY BE USED for Bus-powered USB Hard Disk Drives and USB Flash Drives. The following configurations can be used: CAUTION • One or two USB Flash Drives • One Flash Drive and One Bus-powered Hard Disk Drive • One Bus-powered Hard Disk Drive DO NOT plug in TWO Bus-powered Hard Disk Drives at the same time. Rear of System The two USB ports at the back of the system SHOULD ONLY BE USED for the following devices: • NOTE: CAUTION 1-8 Color or Report Printer When connecting an external printer to the LOGIQ E9 via the USB port on the back of the system, you MUST ensure that the power supplied to the printer is fed from the same power feed as the LOGIQ E9. This assures compliance to leakage currents. • Flash Drive • Service Key ONLY plug in devices to the USB ports located at the rear of the system WHILE the LOGIQ E9 is NOT powered up. If you plug in a device while the LOGIQ E9 is powered on, your system may become unusable. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 Console Overview Peripheral/Accessory Connector Panel LOGIQ E9 peripherals CAN ONLY BE properly connected using the rear connector panel located behind the rear door: Color Digital or Report printer, Audio In/Out, DVI Analog Video Output, and Ethernet. CAUTION For compatiblity reasons, use only GE approved probes, peripherals, or accessories. DO NOT connect any probes or accessories without approval by GE. 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 To avoid breaking the back cover while opening it in order to connect up the network cable, use a paper clip and pull hard to open up the back cover door. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 1-9 Getting Started Peripheral/Accessory Connector Panel (continued) Figure 1-4. Peripheral/Accessory Connector Panel Table 1-1: No. Peripheral/Accessory Connector Panel Descriptions Item Type of connector USB Ports USB 2.0 Audio In/Out ACR DVI Port Connector DVI Analog Video Output. Note: Use a DVI to VGA Adapter in order to connect an analog monitor. Ethernet 1-10 RJ-45 Modular, 8-pin LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 Console Overview Control Panel Map Figure 1-5. Control Panel 1. Probe and Cord Holder 2. USB Ports (2) 3. Touch Panel and Joystick controls 4. Keyboard 5. Feature Keys 6. Mode/Gain/XYZ Controls 7. TGC 8. Trackball, Trackball Keys, Pointer, Measure, Comment, Body Pattern, Clear, Zoom, 3D/4D, P1 9. L/R, Start/Stop, Freeze 10. Steer/Width/Depth/Reverse 11. Auto 12. P2, P3, P4 LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 1-11 Getting Started Touch Panel Figure 1-6. Exam Function Controls 1. Patient: Enters Patient screen 2. Scan: Enters scanning mode screen 3. Reports: Activates default report and Touch Panel of report choices. 4. End Exam: Activates Image Management and Touch Panel with end of exam options. NOTE: 5. Utility: Activates system configuration menus. 6. Model: Selects the application to use. 7. Probe Indicator: Indicates and selects the probes. Different menus are displayed depending on which Touch Panel is selected. At the bottom of the Touch Panel, there are five combination rotary dials/push buttons. The functionality of these rotaries changes, depending upon the currently-displayed menu. Press the button to switch between controls, or rotate the dial to adjust the value, or move the control left/right or up/down to adjust the value. 1-12 LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 Console Overview Monitor Display Figure 1-7. Figure 1-8. NOTE: Monitor Display Tour Monitor Display Tour 2 The date on the monitor may truncate the century when using the YYYY-MM-DD date format. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 1-13 Getting Started Monitor Display (continued) 1. Institution/Hospital Name, Date, Time, Operator Identification. 2. Patient Name, Patient Identification, Alternate (Second) Patient Name/Patient Identification. 3. Power Output Readout 4. GE Symbol: Probe Orientation Marker. 5. Worksheet/Direct Report. 6. Gray/Color Bar. 7. Measurement Summary Window. 8. Image. 9. Measurement Calipers. 10. Measurement Results Window. 11. Scan Assistant Icons 12. Image Preview. 13. Image Clipboard. 14. Probe Identifier. Exam Preset. 15. Imaging Parameters by Mode. 16. Focal Zone Indicator. 17. TGC. 18. Depth Scale. 19. Body Pattern. 1-14 20. Cine Gauge. 21. Current date and time, Caps Lock: (lit when on), network connection indicator (PC=connected, PC with X=not connected), wireless LAN indicator (WLAN=connected, WLAN with X=not connected), DVR status, InSite ExC status, InSite ExC controls, system messages display. 22. Image Management Icons: a. Active Images screen b. Delete Images screen c. Next/Previous Image(s); and Clipboard Slide Show if you press and hold down the [Ctrl] key + Next or Previous Arrow d. Save As Menu e. Number of Images in Exam f. Thumbnail Size 23. Trackball Key Functionality Status. 24. 6Tc Probe temperature display 25. 6Tc Probe angle display LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 Console Overview Brightness Adjusting the monitor's brightness is one of the most important factors for proper image quality. If these controls are set incorrectly, the Gain, TGC, Dynamic Range and even Power Output may have to be changed more often than necessary to compensate. The proper setup displays a complete gray scale. The lowest level of black should just disappear into the background and the highest white should be bright, but not saturated. To adjust the brightness: 1. Press the right adjustment button to increase brightness. 2. Press the left adjustment button to decrease brightness. The amount of brightness is shown on a slide bar on the screen. Figure 1-9. Brightness adjustment button 1. Adjustment (+) Button 2. Adjust (-) Button Record any changes to the final brightness settings and leave this information with the system. Generally speaking, do not change the controls once they have been set. Once set, the display then becomes the reference for the hard copy device(s). Table 1-2: NOTE: Brightness Settings (Recommended) Room Condition Brightness Dark Room (Factory default) 60 Bright Room 100 After readjusting the monitor's Brightness, readjust all preset and peripheral settings. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 1-15 Getting Started Moving the System Before moving the system 1. Press the Power On/Off switch to power off the system. See ‘Power Off’ on page 1-24 for more information. HINTS Make sure to dock the Operator Panel prior to powering down the system or putting it in Sleep Mode. You cannot lock the Operator Panel into place after the system has been shut down or placed into Sleep Mode. 2. Unplug the power cord. 3. All cables from off-board peripheral devices (external Color Digital/Report printer, etc.) and the ethernet connection must be disconnected from the console. 4. Ensure that no loose items are left on the console. 5. Wind the power cable around the cable hook below the rear handle. To prevent damage to the Power Cord, DO NOT pull excessively on the cord or make sharp bends while wrapping. 6. Connect all probes to be used while off site. Ensure that probe cables are out of the way from the wheels and not protruding beyond the console. Use the probe management hooks located below the Operator Panel to further secure the probe cables. NOTE: If more than four (4) probes are intended to be used, store the additional probes securely. 7. Store all other probes in their original cases or in soft cloth or foam to prevent damage. 1-16 LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 Moving the System Before moving the system (continued) 8. Store sufficient gel and other essential accessories in the provided space. CAUTION DO NOT place probes into the front pocket storage area when moving the system. This is not a storage space for probes. 9. Adjust the LCD monitor and control panel to their lowest positions by using the up/down switch on the front of the operator panel. Make sure the operator panel is locked in place. CAUTION When the system is not in use AND/OR before moving/ transporting the system, make sure that the monitor arm locks firmly and flip down the monitor to prevent system damage. 10. Unlock the wheels. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 1-17 Getting Started When moving the system 1. Always use the front handle grips to move the system. 2. Take extra care when moving the system long distances and on inclines. Ask for help if necessary. Avoid ramps that are steeper than ten degrees to avoid tipping over the system. NOTE: Wheel chair ramps are usually less than five degrees. Utilize additional care and personnel when moving on a steep incline (>5 degrees) or loading the system into a vehicle for transport. DO NOT attempt to move the console using any cables or fixtures, such as the probe connectors. CAUTION 3. Use the foot brake (pedal), located on the bottom of the system in the front, when necessary. 4. Do not let the system strike walls or door frames. 5. Use extra care when crossing door or elevator thresholds. 6. Once the destination is reached, lock the wheels. CAUTION The system weighs approximately 135kg (298lbs). To avoid possible injury and equipment damage: • 1-18 Be sure the pathway is clear. • Limit movement to a slow careful walk. • Use two or more persons to move the system on inclines or long distances. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 Moving the System Operator Panel Movement Controls The system Operator Panel can be freely moved in all directions. The vertical displacement of the Operator Panel is motor driven. The control buttons are located adjacent to the handles. Figure 1-10. Operator Panel Movement Controls To move the operator panel sideways, press and hold down the left button to release and move the Operator Panel sideways until it is in the desired position. To park the Operator Panel, after moving Operator Panel sideways to the desired position, release the left button. After releasing the left button, the system will lock into position after 3 seconds. HINTS Make sure to dock the Operator Panel prior to powering down the system or putting it into Sleep Mode. You cannot lock the Operator Panel into place after the system has been shut down or placed into Sleep Mode. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 1-19 Getting Started Operator Panel Movement Controls (continued) To raise/lower the Operator Panel, press and hold down the Up/ Down toggle button (right button) accordingly to raise or lower the Operator Panel. Release the Up/Down button when the Top Console is in the desired height. To manually adjust the Operator Panel, manipulate the metal lever located in-between the slots on the rear of the LOGIQ E9. 1-20 CAUTION When power is off, the Operator Panel is loose, no breaks are applied. If you do not dock the operator panel, it will move freely. Please dock the Operator Panel it you will be moving or transporting the system. CAUTION When power is on, the brakes are applied to the Operator Panel. To move the Operator Panel, release it by using the Operator Panel Movement Controls. This helps to ensure the life of the brakes. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 Moving the System Setting the front wheels lock The pedal is located between the front wheels of the unit and enables the user to control the movement of the wheels. Figure 1-11. Front Pedal Table 1-3: Front Pedal Functions Pedal position Function 1. Left—Swivel Lock Swivel Lock. To move the system, press the Swivel Lock to set the wheels in a forward-to-back position. First move the system in the direction you will be going, then press the Swivel Lock. To release the Swivel Lock, press the center brake release. 2. Right—Parking Brake Park. To set the brake, press the right pedal. To release the brake, press the center brake release. CAUTION When two or more people are releasing the swivel/pivot wheel controls with the front and rear pedals, take extra precaution to prevent unexpected movement which could result in possible toe injuries. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 1-21 Getting Started System Start-Up Power On CAUTION Press the Power On/Off switch to turn the power on. The circuit breaker must also be in the on position. For circuit breaker location, See ‘Circuit breaker’ on page 1-26 for more information. Login Personal IDs and associated passwords can be preset on the LOGIQ E9. If the Use Auto Logon preset is blank, you are prompted to login. Figure 1-12. Operator Login Window 1. Operator: Select the Operator. 2. Password: Enter Operator’s password (optional). 3. Select type of Logon or Cancel. 1-22 • OK: Standard logon • Cancel: Cancel logon LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 System Start-Up Sleep Mode Use Sleep Mode when you do a portable exam in order to reduce the time to start up the system. When you use Sleep Mode, it takes ~90 seconds to start up the system versus 2-3 minutes. To activate Sleep Mode, 1. Press the On/Off button and select Sleep. 2. When the On/Off button turns from Green to Orange, unplug the power cord from the wall. 3. To bring the system out of Sleep Mode, press the On/Off button. WARNING Sleep mode is not intended to replace the shutdown process. The system should be fully shutdown every day. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 1-23 Getting Started Power Off To power off the system: 1. Set the brake and use the operator panel movement controls to lock the control panel in place. HINTS Make sure to dock the Operator Panel prior to powering down the system or putting it in Sleep Mode. You cannot lock the Operator Panel into place after the system has been shut down or placed into Sleep Mode. 2. When you shutdown the system, enter the scan screen and lightly press the Power On/Off switch at the front of the system once. The System-Exit window is displayed. NOTE: DO NOT press and hold down the Power On/Off switch to shutdown the system. Instead, lightly press the Power On/ Off switch and select Shutdown. 3. Using the Trackball, select Shutdown. The shutdown process takes a few seconds and is completed when the control panel illumination shuts down. NOTE: ONLY if the system has not fully shut down in 60 seconds should you press and hold down the On/Off switch until the system shuts down. 4. Disconnect the probes. Clean or disinfect all probes as necessary. Store them in their shipping cases to avoid damage. CAUTION DO NOT turn off the circuit breaker before the Power On/Off switch LED is off. Data may be lost or system software damaged if the circuit breaker is turned off before the Power On LED is off. NOTE: When the Extended Power Supply (EPS) is installed, battery replacement may be necessary if the circuit breaker is turned turned off for long periods of time (3 to 6 months). Additional System Information For optimum system operation, we recommend that you restart the system at least once every 24-hour period. If you shut down the system at the end of the day, no other action is needed. 1-24 LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 System Start-Up Crash Recovery Instructions In case of a system crash, power cycle the system. Upon boot-up, all images and measurements, except for generic worksheets, are preserved in the system. When the system returns, the system alerts you that unsaved images are still in the system from the previous patient. Respond to the prompt to continue the current patient. Check that all images and measurements have been preserved in the system. Then resume the exam. If the system fails to respond to your commands within a typical period of time, you need to manually reset the system. Simply hold down the power switch to initiate a normal power down sequence. After the system has completely shut down (power switch amber), restart the system using the standard power-up sequence. All images and measurements, except for generic worksheets, are preserved in the system. When the system has fully powered up, the system alerts you that unsaved images are still in the system from the previous patient. Respond to the prompt to continue the current patient. Check that all images and measurements have been preserved in the system. If you do not have any images on the clipboard, the patient must be retrieved from the database. Then resume the exam. Unexpected Power Loss In case of unexpected power loss, 1. Check the system On/Off LED color. 2. If the LCD monitor shuts down along with the front end, then the system has detected a power failure. It will then activate the extended power supply (EPS). The EPS permits us to maintain the integrity of the scanner database. The system On/Off switch will be green in this situation. 3. Wait about 2 minutes after such an incident and then turn the circuit breaker off (rear panel of the LOGIQ E9) or unplug the scanner. 4. Give the system approximately one minutes. The systme On/Off switch should be dark. 5. Turn on the LOGIQ E9 by either turning on the circuit breaker or plugging in the scanner. 6. Turn on the scanner by pressing the system On/Off switch. NOTE: The LOGIQ E9 should be plugged into the regular power outlet and not the emergency power outlet. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 1-25 Getting Started Circuit breaker The Circuit Breaker is located at the rear panel of the system. When set to On, the Circuit Break supplies main power to all internal systems. When set to Off, the Circuit Breaker removes main power from all internal systems. The circuit breaker automatically shuts off power to the system in case of a power overload. If a power overload occurs: 1. Turn off all peripheral devices. 2. Reactivate the Circuit Breaker switch. The Circuit Breaker switch should stay in the On position; DO NOT hold the switch in the On position. If the Circuit Breaker switch remains On, follow the Power On procedure previously described. NOTE: If the Circuit Breaker switch does not remain in the On position or trips again: 1. Disconnect the Power Cable. 2. Call Service immediately. DO NOT attempt to use the system. Figure 1-13. Circuit Breaker (located at the rear of the system) 1-26 LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 Probes Probes Introduction Only use approved probes. DO NOT plug any LOGIQ 9 probes into the LOGIQ E9 system. Use the left-most probe port for the 3CRF, S1-5, S4-10, and 6Tc probes; use the 3 right probe ports for any “___-D” probe. Figure 1-14. Probe Connectors 1. 3CRF, S1-5, S4-10, and 6Tc Probe Connector 2. _____-D Probe Connector Refer to the Probes chapter for more information. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 1-27 Getting Started Connecting the Probe Probes can be connected at any time, regardless of whether the console is powered on or off. To ensure that the ports are not active, place the system in the image freeze condition. To connect a probe: 1. Place the probe's carrying case on a stable surface and open the case. 2. Carefully remove the probe and unwrap the probe cord. 3. DO NOT allow the probe head to hang free. Impact to the probe head could result in irreparable damage. Use the integrated cable management hook to wrap the cord. Inspect the probe before and after each use for damage or degradation to the housing, strain relief, lens, seal and connector. DO NOT use a transducer which appears damaged until functional and safe performance is verified. A thorough inspection should be conducted during the cleaning process. 4. Turn the connector locking handle to the left. 5. Align the connector with the probe port and carefully push into place. Before inserting the 3CRF, S1-5, S4-10, or 6Tc probe connector into the probe port, inspect the probe connector pin. If the pin is bent, do not use the probe until it has been inspected and repaired/replaced by a GE Service Representative. 6. Turn the connector locking handle to the right to secure the probe connector. 7. Carefully position the probe cord so it is free to move, yet not dragging on the floor. CAUTION 1-28 Fault conditions can result in electric shock hazard. Do not touch the surface of probe connectors which are exposed when the probe is removed. Do not touch the patient when connecting or disconnecting a probe. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 Probes Cable Handling Take the following precautions with probe cables: • Keep free from wheels. Use the cable hooks located below the operator panel. • Do not bend the cable acutely • Avoid crossing cables between probes. Activating the Probe To activate the probe, select the appropriate probe from the probe indicators on the Touch Panel. Figure 1-15. Probe Indicators 1. Probe Indicators The probe's default settings for the mode and selected exam are used automatically. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 1-29 Getting Started Disconnecting the Probe Probes can be disconnected at any time. However, the probe should not be active when disconnecting the probe. 1. Ensure the probe is deactivated. Deactivate by selecting another probe or pressing Freeze. 2. Move the probe locking handle to the left. 3. Pull the probe and connector straight out of the probe port. 4. Carefully slide the probe and connector away from the probe port and around the right side of the keyboard. 5. Ensure the cable is free. 6. Be sure that the probe head is clean before placing the probe in its storage box or wall hanging unit. 1-30 LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 Probes LOGIQ E9 Applications The LOGIQ E9 probes are ONLY approved for use for the applications listed in the table below. Small Parts X X X X Periph. Vasc./ Vascular X X X X X X X X Cardiac, Adult X X Cardiac, Pediatric X X X X X Gynecology X X X X X Pediatrics X X Neonatal X X Urology X Transcranial X X X X X X X X X X X X X X X X X Transvaginal X X Transrectal X X Transesophageal CAUTION X X Obstetrics Intraoperative P6D 6Tc X 6S-D P2D RIC5-9-D RSP6-16-D RAB2-5-D RAB4-8-D X X RNA5-9-D X IC5-9D S4-10 S1-5 X 3CRF X C1-5-D M6C-D Abdomen M5S-D Probe Indications for Use L8-18i-D M4S-D 11L-D Probe Application ML6-15-D 9L-D Table 1-4: X Probes for transvaginal and transrectal applications require special handling. Refer to the user documentation enclosed with these probes. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 1-31 Getting Started LOGIQ E9 Features- S1-5 S4-10 C1-5-D M6C-D 3CRF IC5-9-D RNA5-9-D RAB2-5-D RAB4-8-D RIC5-9-D RSP6-16-D 6Tc 6S-D P2D X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X SRI-HD X X X X Coded Contrast X LOGIQ View X X X X Virtual Convex X X X Easy 3D X X Advanced 3D X X Tru3D X X X X X X X Biopsy Guide X X X CrossXBeam X X X X PDI X X X X V Nav X X X Scan Assistant X X X Elastography X Anatomical M X X X X X X X X X X X X CW X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X CAMM X X X X X X X X X X X X X X X X X X X X X X X X X X X X X Color M X X X TVI X X X TVD X X X 1-32 X X X X X X X X X Beta View ACMM (Anat. Color M) X X X X X X X X X X X X X X X X X X 4D Raw Data X P6D M5S-D X 11L-D X ML6-15-D X 9L-D X Coded Harmonics Probe Feature Probe Features L8-18i-D M4S-D Table 1-5: LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 Probes Beta View Beta View enables you to steer the probe head in elevation direction without moving the probe. This feature is available on the 4D RIC5-9-D and RNA5-9-D probes during live scanning and is especially useful during an endovaginal or neonatal head exams. The Beta View Touch Panel control appears on the B-Mode Touch Panel when you select either of these two probes. You can adjust the Beta View control Right /Left or Up/Down. When you press down on the Beta View control, the probe head re-centers itself. Beta View is not available while the image is Frozen, during an image Recall, during a Biopsy procedure, or during Volume Navigation. When these controls are selected, the Beta View Touch Panel control is hidden and unavailable. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 1-33 Getting Started Beginning an Exam Scanning a New Patient 1. Press Patient. 2. Press New Patient on the Patient menu. 3. If there are images on the clipboard, a pop-up menu appears. Specify whether you want to store images permanently, delete images, or go to active images. 4. Choose the exam category. 5. Verify the dataflow. NOTE: DO NOT use the removable media Dataflows on the New Patient menu. NOTE: The system can display a warning dialog when the patient is registered to “No Archive”. If the “Warn register to No Archive” preset is selected in the Utility -> Connectivity -> Miscellaneous menu, a warning displays. A different dataflow for permanent storage of patient data should be selected. 6. Fill in patient information. NOTE: You can also select a patient from the patient database at the bottom of the Patient menu if the patient has a patient ID. Columns drive the ordering of the patients displayed. The column that you select drives the order of the displayed patient database. NOTE: Do not use the following characters for labelling: “‘\/:;.,*<>|+=[] 7. Select Register. Enter Past OB Exam information, if desired. 8. Select the probe to start scanning (or select Exit, Esc, Scan, or Freeze). 9. Perform the exam. 1-34 LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 Beginning an Exam Scanning a New Patient (continued) 10. Store the raw data to the clipboard. To store the still image, press Freeze and run the cineloop using the Trackball. Select the frame and press P1 (or the assigned Printer key). To store the cineloop, press Freeze and run the cineloop using the Trackball. Select the start/end frame and run the selected loop. Press P1 (or the assigned Print key). HINTS When you press Print button during scan (Live Store), the LOGIQ E9 stores the cine for the specified length of time for the Time Span (NoECG) preset, found under Utility -> System Imaging -> Cine Loop Store. When you press Print button during scan (Live Store) with ECG, the LOGIQ E9 stores the cine for the specified number of heart cycles in Utility -> Application -> Image Store -> Number of heart cycles. If you set the Number of heart cycles more than 1 without ECG in Utility -> Application -> Image store, the LOGIQ E9 stores the cine for the length of time “Time Span (no ECG) x Number of heart cycles”. 11. When you have completed the study, press End Exam. The image management screen displays. Select the images (still frame or cineloop) you want to store or select Select All to store all images. Select Permanent Store to store the images permanently. CAUTION NOTE: After completing the measurement, verify that the measurement result window is updated before you send or save the image. Return to the patient screen automatically from the scan screen when you select OK from the “ID is not unique” warning message. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 1-35 Getting Started Patient Screen Figure 1-16. Patient Screen (Example: Category OB) 1. Image Management 2. Function Selection 3. EZBackup/EZMove 4. Dataflow Selection 5. Exit 6. Patient Information 7. Category Selection 8. Exam Information 9. Patient View 10. Scan Assistant Program 1-36 LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 Beginning an Exam Patient Screen (continued) Enter Patient Data with the alphanumeric keyboard. To navigate through the Patient Entry menu, use the Tab key or Trackball and Set to move and fix the cursor. The Patient Screen details are: 1. Image Management • Patient–Provides a search and creation of patient. (currently selected) • Image History–Provides a list of images per exam for the currently selected patient. • Active Images–Provides preview of the currently selected exam. • Data Transfer–Provides an interface to handle patient data from a remote device. 2. Function Selection • New Patient–Used to clear patient entry screen in order to input a new patient’s data into the database. • Register–Used to enter new patient information into the database prior to the exam. NOTE: If you are using the auto-generate Patient ID feature, do not select Register. NOTE: It is always a good practice to Register all patients. • NOTE: Details–Select the Detail box to activate/deactivate the exam details. Exam details include Indications, Comments, Admission Number, Performing Physician’s Telephone Number, Referring Physician’s Telephone Number, Operator Telephone Number and Exam Description. Select preset at Exam Description to use as the identifier in DICOM. 3. EZBackup/EZMove–One-step method to backup (move and delete patient images) to an external media. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 1-37 Getting Started Patient Screen (continued) 4. Dataflow Selection–Select the appropriate dataflow. NOTE: If you use a DVD-R or DVD-RAM, select DICOM CD Read in Dataflow. If you place the cursor on the icon, the pop-up menu displays disk capacity. Figure 1-17. Dataflow Pop-up WARNING Ensure you have selected a dataflow. If No Archive is selected, no patient data is saved. A Ø appears next to Dataflow if No Archive is selected. 5. Exit–Used to exit Patient Menu. 6. Patient Information • Patient ID Number • Patient Name–Last, First and Middle • Alternate (Other, Second) Patient ID Name and Number. The system now allows you to enter a second identification number for the same patient, which may be required in certain countries. This is only displayed if enabled on the Connectivity -> Miscellaneous screen. • DOB (Birthdate) • Age (automatically calculated when birthdate is input) • Sex 7. Category Selection Select from 8 exam application categories: Abdomen, Obstetrics, Gynecology, Cardiology, Vascular, Urology, Small Parts or Pediatrics. When a category is selected, the measurement and category presets are displayed. 1-38 LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 Beginning an Exam Patient Screen (continued) 8. Exam Information Shows the Current/Active Exam information. Information pertinent to the selected exam category appears in the window. All possible information needs to be entered. • Images–Displays the selected exam’s images. • Clear–Clears existing data. • Past Exam (only for OB)–Input past exam data (register the patient before using). 9. Patient View–Lists the patients in the database. NOTE: Use Ctrl + A to select all from the Data Transfer list/Patient view. NOTE: When you double-click the patient on the patient list with the Set key, the Review screen or New Exam entry screen displays. Select Review or New Exam in Utility -> Connectivity -> Miscellaneous -> Double click on patient list to start preset. • Search key–select search item from Patient ID, Last Name, First Name, Other ID, Birthdate, Sex, Exam Date, Exam Today, Accesstion Number, Exam Description, Exam Date Before, Exam Date Between, Exam Date After, Locked (Y, N) or Img. Archived (Y, N). NOTE: If “Exam Date Between” is selected, the Input Dialog displays and you can select the date from the displayed calender. NOTE: Img. Archived means that the exam was backed up to external media by EZBackup or Export. • String–enter appropriate information. If you select Locked (Y, N) or Archived (Y, N) for the Search key, enter Y (Yes) or N (No). NOTE: If “Exam Date Between” is used for the Search key, the From and To dates are separated by a “-” (dash) in the Search String. • Clear–Clears the entered string. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 1-39 Getting Started Patient Screen (continued) • Listing XX of XXX -- Displays the quantity of patients in the search window and the quantity of patients in the database. • Review–Select Patient/Exam for review. • Resume Exam–Continues the exam for that patient if you select the last exam of the day. • New Exam–Creates a new exam on a current patient. • Delete–Deletes Patient/Exam. NOTE: “Delete” is only displayed when you login as Administrator. • Lock/Unlock–Locks the exam/patient. Prevents move and delete functions. Exam View–Displays the Exam History of the selected patient. • Disk - Displays the disk name on which you saved the exam’s image data. If “+” displays behind the disk name, the data is saved on two or more disks. 10. Scan Assistant Program. The Scan Assistant Program is either selected automatically or manually, depending on the preset as configured on the Utility--> System--> General page. CAUTION 1-40 To avoid patient identification errors, always verify the identification with the patient. Make sure the correct patient identification appears on all screens and hard copy prints. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 Beginning an Exam Patient Screen (continued) CAUTION To maintain optimum performance and to safeguard patient data, keep the total number of patients in the database below 1,000. To reduce the total number of patients in the database, perform the following procedure. 1. Before starting EZBackup, select “Unlock All” on the Utility -> Admin -> Logon screen. Prepare the unformatted CD-R or DVD-R before EZBackup. NOTE: Formatted CD-R or DVD-R cannot be used for EZBackup. 2. First perform EZBackup and then Backup (Patient Archive and Report Archive). 3. Go to the patient screen, select the patients/exams to delete. Select “Delete” to delete the selected data. NOTE: Removing image data with the “EZMove” function does not reduce the patient number in the database. NOTE: Ensure that all patients are exported or backed up BEFORE deleting them. We recommend attaching the patient list to the EZBackup media. Insert the media and select DICOM CD Read for dataflow (if you use a USB drive, select DICOM USB Drive I Read). Select any patient and press the programmable Set key to print the patient list on the digital printer or PC printer. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 1-41 Getting Started 1-42 LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 Chapter 2 Performing an Exam Optimizing the Image and Measurement and Analysis LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 2-1 Performing an Exam Optimizing the Image B-Mode Controls Table 2-1: Control Possible Bioeffect B-Mode Controls Description/ Benefit Depth Yes Depth controls the distance over which the B-Mode images anatomy. To visualize deeper structures, increase the depth. If there is a large part of the display which is unused at the bottom, decrease the depth. Gain No B-Mode Gain increases or decreases the amount of echo information displayed in an image. It may have the effect of brightening or darkening the image if sufficient echo information is generated. Focus Yes Increases the number of focal zones or moves the focal zone(s) so that you can tighten up the beam for a specific area. A graphic caret corresponding to the focal zone position(s) appears on the right edge of the image. Auto Optimize No Auto Optimize (Auto) lets you optimize the image based upon a the actual B Mode image data (Auto Tissue Optimize, ATO). The preset levels (Low, Medium, and High) allow you to pick a preference for the contrast enhancement in the resulting image. Low does the least amount of contrast enhancement, high does the most. Auto is available in single or multi image, on live, frozen or CINE images (in B-Mode only), and while in zoom, in Color Flow Mode, and in Spectral Doppler. Auto in Color Flow Mode automatically adjusts the overall color gain. If you find that the gain adjustment that is automatically performed consistently results in more or less gain than you expect, then the Auto Optimize Adjustment allows you to adjust the result of the Auto feature (-5 to 5 range) so that the result more consistently matches your expectation. Auto in PW Doppler Mode optimizes the spectral data. Auto adjusts the Velocity Scale (live imaging only), baseline shift, dynamic range, and invert (if preset). Upon deactivation, the spectrum is still optimized. Mode Cursor No Displays the M/D-Mode cursor on the B-Mode image. 2-2 LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 Optimizing the Image Table 2-1: Control B-Mode Controls (Continued) Possible Bioeffect Description/ Benefit SRI-HD No SRI-HD (Speckle Reduction Imaging High Definition) is an adaptive algorithm to reduce the unwanted effects of speckle in the ultrasound image. Image speckle usually appears as a grainy texture in otherwise uniform areas of tissue. Its appearance is related to image system characteristics, rather than tissue characteristics, so that changes in system settings, such as probe type, frequency, depth, and others, can cange the appearance of the speckle. Too much speckle can impair image quality and make it difficult to see the desired detail in the image. Likewise, too much filtering of speckle can mask or obscure desired image detail. Extra care must be taken to select the optimal SRI-HD level. SRI-HD is available in B-Mode imaging and may be used with any transducer or clinical application when image speckle appears to interfere with the desired image detail. CrossXBeam No CrossXBeam is the process of combining three or more frames from different steering angles into a single frame. CrossXBeam is available on Convex and Linear probes. CrossXBeam combines multiple co-planar images from different view angles into a single image at real-time frame rates, using bi-cubic interpolation. Coded Harmonic Imaging (CHI) Yes Harmonic imaging utilizes Digitally Encoded Ultrasound (DEU). Coded Harmonics enhances near field resolution for improved small parts imaging as well as far field penetration. Frequency Yes Multi Frequency mode lets you downshift to the probe's next lower frequency or shift up to a higher frequency. Steer Yes You can slant the B-Mode or Color Flow linear image left or right to get more information without moving the probe. The angle steer function only applies to linear probes. Virtual Convex Yes On Linear and Sector probes, Virtual Convex provides a larger field of view in the far field. Virtual Convex is always active with Sector probes. TGC No TGC amplifies returning signals to correct for the attenuation caused by tissues at increasing depths. TGC slide pots are spaced proportionately to the depth. The area each pot amplifies varies as well. A TGC curve may appear on the display (if preset), matching the controls that you have set (except during zoom). You can choose to deactivate the TGC curve on the image. Width Yes You can widen or narrow the size of the sector angle to maximize the image's region of interest (ROI). Tilt Yes You can steer the sector angle to get more information without moving the probe while in B-Mode, M-Mode, Doppler Mode, and Color Flow Mode. Tilt is not available on Linear probes. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 2-3 Performing an Exam Table 2-1: Control Possible Bioeffect B-Mode Controls (Continued) Description/ Benefit Dynamic Range No Dynamic Range controls how echo intensities are converted to shades of gray, thereby increasing the adjustable range of contrast. The Dynamic Range control name changes to Compression on frozen images. Reverse (if Preset) No Flips the image 180 degrees left/right. Line Density Yes Optimizes B-Mode frame rate or spatial resolution for the best possible image. Maps No The system supplies B, M, and Doppler Mode system maps. Frame Average No Temporal filter that averages frames together, thereby using more pixels to make up one image. This has the effect of presenting a smoother, softer image. Colorize No Colorize is the colorization of a conventional B-Mode image or Doppler Spectrum to enhance the user's ability to discern B, M, and Doppler Mode intensity valuations. Colorize is NOT a Doppler Mode. NOTE: You can colorize realtime or CINE images or Timeline CINE, but not DVR images. Colorizes the gray scale image to enhance the eye's discrimination capability. Spectrum Colorize colorizes the spectrum as a function of power using the inverse of the Colorize map for the signal intensity in each Doppler line. Colorize enhances the visibility of the spectrum's characteristics and enhances your ability to identify spectral broadening and the edge contours of the spectrum used to define the peak frequency/velocity. The gray bar displays while Colorize is activated. Rotation No Flips the image 180 degrees up/down. CAUTION: When reading a rotated image, be careful to observe the probe orientation to avoid possible confusion over scan direction or left/right image reversal. Rejection No Selects a level below which echoes will not be amplified (an echo must have a certain minimum amplitude before it will be processed). Suppression No Suppresses the noise in the image. 2-4 LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 Optimizing the Image Color Flow Mode Controls Color Flow Mode and Color M-Mode are Doppler Modes intended to add color-coded qualitative information concerning the relative velocity and direction of fluid motion within the B-Mode or M-Mode image. Table 2-2: Control Color Flow Mode Controls Possible Bioeffect Description/ Benefit Flow Selection No In the Lower Extremity Vein (LEV) and Abdominal applications, you can quickly select the flow state via a shortcut on the Color Flow Mode Touch Panel menu. Gain No Gain amplifies the overall strength of echoes processed in the Color Flow window or spectral Doppler timeline. Scale (Velocity Scale) Yes Increases/decreases the Scale on the color bar. Wall Filter No Filters out low flow velocity signals. It helps get rid of motion artifacts caused from breathing and other patient motion. Color Width Yes Color Width sizes and positions the color window. Invert (Color Invert) No Lets you view blood flow from a different perspective, e.g., red away (negative velocities) and blue toward (positive velocities). You can invert a real-time or frozen image. NOTE: Invert reverses the color map, NOT the color Scale. Baseline No Changes the Color Flow or Doppler spectrum baseline to accommodate higher velocity blood flow. Minimizes aliasing by displaying a greater range of forward flow with respect to reverse flow, or vice versa. Baseline adjusts the alias point. The default baseline is at the midpoint of the color display and at the midpoint of the color bar reference display. Angle Steer Yes You can slant the ROI of the Color Flow linear image left or right to get more information without moving the probe. The Angle Steer function only applies to linear probes. Accumulation No Accumulation enhances the flow in an image. Available in Contrast, Color Flow, and PDI. Color Flow Line Density Yes Optimizes the Color Flow frame rate or spatial resolution for the best possible color image. Map No Allows you to select a specific color map. After you have made your selection, the color bar displays the resultant map. Threshold No Threshold assigns the gray scale level at which color information stops. Frame Average No Averages color frames. Transparency Map No Brings out the tissue behind the color map. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 2-5 Performing an Exam Table 2-2: Control Possible Bioeffect Color Flow Mode Controls (Continued) Description/ Benefit Spatial Filter No Smooths out the color, makes it look less pixely. Flash Suppression No Activates/deactivates Flash Suppression, a motion artifact elimination process. Sample Vol (Sample Volume) Yes Places the sample volume gate on the Color Flow image. The gate is positioned over a specific position within the vessel. Sample Volume Length (SV Length) Yes Sizes the sample volume gate. Packet Size Yes Controls the number of samples gathered for a single color flow vector. Map Compress No When you increase the value, high velocity elements in the map are compressed so that the map darkens. When you decrease the value, low velocity elements in the map are compressed so that the map lightens. The effect is visible in the color bar. CF/PDI Vertical Size No You can set the default CF/PDI ROI vertical size. CF/PDI Width No You can set the default CF/PDI ROI width. CF/PDI Center Depth No You can set the default CF/PDI center depth. CF/PDI Frequency (MHz) No You can set the default CF/PDI Frequency (MHz). CF/PDI Auto Frequency No You can set the default CF/PDI Auto Frequency. CF/PDI Focus Depth (%) No You can set the default CF/PDI center depth. Power Doppler Imaging (PDI) No Power Doppler Imaging (PDI) is a color flow mapping technique used to map the strength of the Doppler signal coming from the flow rather than the frequency shift of the signal. Using this technique, the ultrasound system plots color flow based on the number of reflectors that are moving, regardless of their velocity. PDI does not map velocity, therefore it is not subject to aliasing. 2-6 LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 Optimizing the Image M-Mode Controls Table 2-3: Control Possible Bioeffect M-Mode Controls Description/ Benefit Sweep Speed Yes Changes the speed at which the timeline is swept. Available in M-Mode, Doppler Mode and M Color Flow Mode. Anatomical M-Mode Yes Anatomical M-Mode gives you the ability to manipulate the cursor at different angles and positions. The M-Mode display changes according to a motion of the M cursor. Curved Anatomical M-Mode (CAMM) displays a distance/time plot from a free-drawn cursor line. CAMM is available in gray scale, color and TVI. M Color Flow Mode See ‘Color Flow Mode Controls’ on page 2-5. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 2-7 Performing an Exam Doppler Mode Controls Table 2-4: Control Doppler Mode Controls Possible Bioeffect Description/ Benefit Update Yes Toggles between simultaneous and update presentation while viewing the timeline. SV Length (Trackball) Yes Moves the sample volume gate on the B-Mode's Doppler Mode cursor. The gate is positioned over a specific position within the vessel. Doppler sample volume length (SV Length) Yes Sizes the sample volume gate. Scale (Velocity Scale) Yes Adjusts the velocity scale to accommodate faster/slower blood flow velocities. Velocity scale determines pulse repetition frequency. If the sample volume gate range exceeds single gate Scale capability, the system automatically switches to high PRF mode. Multiple gates appear, and HPRF is indicated on the display. Angle Correct No Estimates the flow velocity in a direction at an angle to the Doppler vector by computing the angle between the Doppler vector and the flow to be measured. NOTE: When the Doppler Mode Cursor and angle correct indicator are aligned (the angle is O), you cannot see the angle correct indicator. Quick Angle No Quickly adjusts the angle by 60 degrees. Wall Filter No Insulates the Doppler signal from excessive noise caused from vessel movement. Baseline No Adjusts the baseline to accommodate faster or slower blood flows to eliminate aliasing. Mode Cursor No Displays the Doppler Mode cursor on the B-Mode image. Steer and Fine Steer Yes You can slant the ROI of the Color Flow linear image left or right to get more information without moving the probe. The angle steer function only applies to linear probes. Volume No Controls audio output. Invert No Vertically inverts the spectral trace without affecting the baseline position. Dynamic Range (Compression) No Dynamic range controls how echo intensities are converted to shades of gray, thereby increasing the range of contrast you can adjust. Trace Method (Spectral Trace) No Traces the average mean and peak velocities in realtime or frozen images. Cycles to Average No The average value over a number of cycles (from 1-5). Trace Sensitivity No Adjust the trace to follow the waveform for signal strength. 2-8 LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 Optimizing the Image Table 2-4: Control Doppler Mode Controls (Continued) Possible Bioeffect Description/ Benefit Trace Direction No Specifies trace direction. Cursor Moving No Cursor Moving lets you ‘walk’ Doppler through a vessel while the Doppler gate is moving. Display Format No Changes the horizontal/vertical layout between B-Mode and M-Mode, or timeline only. Modify Auto Calcs No Activates the menu to select which calculations are automatically calculated. Auto Calcs No Activates the calculation automatically which you select in the Modify Auto Calculation when the system is in a state of freeze or live. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 2-9 Performing an Exam 3D Mode Table 2-5: 3D Package Options 3D Type Description Sensor/No Sensor Available Tabs Easy 3D Designed for rendering B Mode and Color Flow Mode images, e.g., Baby Face scans. No sensor 3D Acquisition, Easy 3D, Movie Advanced 3D Designed for rendering B Mode and Color Flow Mode images, e.g., vessel trees. No sensor 3D Acquisition, Easy 3D, Advanced 3D, Movie Acquiring a 3D Scan To acquire a 3D scan, 1. Optimize the B-Mode image. Ensure even gel coverage. 2. Press the 3D control panel key. Two screens appear. NOTE: Set appropriate values for Acq Mode and Scan Plane. Also, set the scan distance before scanning. 3. To start acquiring the image, press Start (Trackball key). 4. To perform a parallel scan, scan evenly. To perform a sweep (fan) scan, rock the probe once. Note the distance of the scan. 5. The 3D volume of interest (VOI) is dynamically assembled on the right side of the screen. NOTE: If the image stops before you’re done scanning, start acquiring the 3D volume of interest again. 6. To complete the 3D scan, press End (Trackball key). NOTE: 2-10 You can also press Freeze, but then you need to also press the 3D key to obtain the final render. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 Optimizing the Image Other Controls Trackball Key Map The current mapping is shown on the trackball mapping display area in the lower, right-hand corner of the display screen. Four Trackball keys surround the Trackball. These Trackball keys are mapped based on the current state of the system (live imaging, frozen imaging, measurements, etc.) Trackball functionality is labeled on the display. To activate new functionality for the Trackball, press the correct key adjacent to the Trackball, as indicated on the display. Zoom Write zooming an image changes the frame rate which tends to change thermal indices. The position of the focal zones may also change which may cause the peak intensity to occur at a different location in the acoustic field. As a result, the MI (TI) may change. Acoustic Output Hazard Observe the output display for possible effects. To zoom an image, adjust Zoom. A reference image appears in the lower, left-hand section of the display. To exit zoom, adjust Zoom until the reference zoom image is removed or press B-Mode. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 2-11 Performing an Exam Split Screen To activate a dual split screen, press L or R.To activate a quad display, press and hold down L. When you activate Split Screen by pressing L, the single image is placed on the left side; when you activate Split screen by pressing R, the single image is placed on the right side. To switch between active images, press L/R. To deactivate, press R until the screen changes. Dual Caliper In split screen, you can draw a caliper, area, ellipse, or spline trace on both the left and right image at the same time. Whichever side of the screen that you annotate is called the “Original” graphic. The copy is called the “Shadow” graphic. Freezing an image To freeze an image, 1. Press Freeze. The Freeze key backlight turns green. If you are in a mixed mode, both screen formats stop immediately. Deactivating Freeze restarts both modes and places a black bar on the trace to indicate the time discontinuity. To reactivate the image, 1. Press Freeze again. NOTE: Deactivating Freeze erases all measurements and calculations from the display (but not from the worksheet). Use the Trackball to start CINE after pressing Freeze. Activating CINE To activate CINE, 1. Press Freeze. 2. Move the Trackball. 2-12 LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 Optimizing the Image Body Patterns To activate body patterns, press the Body Pattern/Ellipse control. A maximum of 6 body pattern packages are displayed on the Touch Panel according to exam category and preset. Select the desired body pattern on the Touch Panel. The selected body pattern is displayed on the monitor. Press the Move Pattern control on the Touch Panel to reposition the body pattern with the Trackball and Set controls. A probe mark is associated with the body patterns and illustrates the probe position on the body pattern. This marker can be placed with the Trackball and rotated with the Ellipse control. The probe mark type is selectable by rotating the Probe Type control on the Touch Panel. There are different choices available with one being a blank selection. To select the active side in dual B-Mode, use the Active Side rotary control at the bottom of the Touch Panel. To clear the body pattern, press the Body Pattern/Ellipse control to activate body patterns and then press the Clear key. Press Set on the keyboard or Scan on the Touch Panel to exit without erasing the body pattern. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 2-13 Performing an Exam Annotating an Image Pressing the Comment key or any keys on the alphanumeric keyboard initiates the comment mode. This assigns the trackball function to controlling the cursor and displays the comment library on the Touch Panel menu. In comment mode, text can be added by using the comment library or by typing from the alphanumeric keyboard. After activating the comment mode, a vertical bar type cursor appears on the screen. Use the Trackball to move the cursor. To delete comments by character, press the Backspace key. To delete all comments and arrow marks, press the Clear key twice immediately after entering the comment mode. To move by words or by text group, press the Tab key. Arrow pointers can be used by activating the F2 (Arrow) key on the keyboard or by selecting the Comment key and then the top Trackball key. When the pointer comes up, it is a GREEN color, indicating it is active and can be moved. Using the Fast Key A keyboard Fast Key is available to record and run a sequence of often-run keystrokes. To create a Fast Key, press the F5 key and follow the on-screen prompts. To start a Fast Key, press the F6 key and follow the on-screen prompts. 2-14 LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 Optimizing the Image Using the Monitor Display Controls to Manage Images You can manage images from the display via these on-display controls. Figure 2-1. Menu Icons 1. Active Images Screen 2. Delete Image 3. Next/Previous Image(s); and Clipboard Slide Show if you press and hold down the [Ctrl] key + Next or Previous Arrow.. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 4. Save As Menu 5. Thumbnail Size 6. Number of Images in Exam 2-15 Performing an Exam Measurement and Analysis Location of Measurement Controls Figure 2-2. Locating Measurement Controls 1. Measure. Activates a measurement caliper and the calculation package associated with the currently selected preset. 2. Clear. During a measurement sequence, erases the measuring caliper and measurement data from the display. When not performing a measurement sequence, clears all calipers and measurements from the display. To remove all annotations/body markers/arrows, hold down the Clear button. 3. Ellipse. After the first caliper for a distance measurement has been set and the second caliper positioned, Ellipse activates the area/ellipse measurement function. During the ellipse adjustment, use the Trackball to increase or decrease the size of the ellipse. Select Cursor Select to adjust the measurement calipers. 4. Trackball. Moves the measurement calipers, selects the measurement on the Summary Window. Trackball also selects items on the Touch Panel with the Pointer and Set keys. 5. Trackball Keys. The functionality of these keys changes (e.g. Set, Mode Cursor, etc) depending on the mode or action. Current functionality is displayed on the lower-right corner of the monitor. 6. Pointer Key. Select to display a pointer on the monitor. 2-16 LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 Measurement and Analysis B-Mode Measurements Two basic measurements can be made in B-Mode. • Distance • Circumference and Area • NOTE: Ellipse Method • Trace Method • Spline Method The following instructions assume that you first scan the patient and then press Freeze. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 2-17 Performing an Exam Distance measurement To make a distance measurement: 1. Press Measure once; an active caliper displays. 2. To position the active caliper at the start point, move the Trackball. 3. To fix the start point, press Set. The system fixes the first caliper and displays a second active caliper. 4. To position the second active caliper at the end point, move the Trackball. A dotted line connects the measurement points, if preset accordingly. 5. To complete the measurement, press Set. The system displays the distance value in the Results Window. The following hints can help you to perform distance measurements: HINTS • • 2-18 Before you complete a measurement: • To toggle between active calipers, press the appropriate Trackball key. • To erase the second caliper and the current data measured and start the measurement again, press Clear once. After you complete the measurement: • To rotate through and activate previously fixed calipers, adjust Cursor Select. • To erase all data that has been measured to this point, but not data entered onto worksheets, press Clear. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 Measurement and Analysis Circumference and area (ellipse) measurement You can use an ellipse to measure circumference and area. To measure with an ellipse: 1. Press Measure once; an active caliper displays. 2. To position the active caliper, move the Trackball. 3. To fix the start point, press Set. The system fixes the first caliper and displays a second active caliper. 4. To position the second caliper, move the Trackball. 5. Adjust the Ellipse control; an ellipse with an initial circle shape displays. 6. To position the ellipse and to size the measured axes (move the calipers), move the Trackball. 7. To increase the size, adjust the Ellipse control in a clockwise direction. To decrease the size, adjust the Ellipse control in a counterclockwise direction. 8. To toggle between active calipers, press the appropriate Trackball key. 9. To complete the measurement, press Set. The system displays the circumference and area in the Results Window. HINTS Before you complete the ellipse measurement: • To erase the ellipse and the current data measured, press Clear once. The original caliper is displayed to restart the measurement. • To exit the measurement function without completing the measurement, press Clear a second time. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 2-19 Performing an Exam Circumference and area (trace) measurement Trace To trace the circumference of a portion of the anatomy and calculate its area: 1. Press Measure. 2. Press the appropriate Trackball key to select Trace; a trace caliper displays. 3. To position the trace caliper at the start point, move the Trackball. 4. To fix the trace start point, press Set. The trace caliper changes to an active caliper. 5. To trace the measurement area, move the Trackball around the anatomy. A dotted line shows the traced area. 6. To complete the measurement, press Set. The system displays the circumference and the area in the Results Window. 2-20 LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 Measurement and Analysis Circumference and area (trace) measurement (continued) Open Trace To trace the circumference of a portion of the anatomy and calculate its length: 1. Press Measure. 2. Press the appropriate Trackball key to select Open trace; a trace caliper displays. NOTE: For open trace, Area (A) is not displayed in the result window. 3. To position the trace caliper at the start point, move the Trackball. 4. To fix the trace start point, press Set. The trace caliper changes to an active caliper. 5. To trace the measurement area, move the Trackball around the anatomy. A dotted line shows the traced area. 6. To complete the measurement, press Set. The system displays the circumference and the length in the Results Window. HINTS Before you complete the trace measurement: • To erase the line (bit by bit) back from its current point, move the Trackball or adjust the Ellipse control counterclockwise. • To erase the dotted line but not the trace caliper, press Clear once. • To clear the trace caliper and the current data measured, press Clear twice. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 2-21 Performing an Exam Circumference and area (spline trace) measurement To trace the circumference of a portion of the anatomy and calculate its area: 1. Press Measure. 2. Press the appropriate Trackball key to select Spline Trace; a Spline trace caliper displays. 3. To position the first caliper at the start point, move the Trackball. 4. To fix the trace start point, press Set. The first caliper turns yellow. The second caliper appears at the same position as the first caliper and is green. NOTE: When pressing the Clear key once, the second caliper disappears and the first caliper is activated. If Clear is pressed again, the first caliper disappears and the Spline trace is cancelled. 5. To position the second caliper, move the Trackball and press Set. The third caliper appears at the same position. NOTE: The Clear key functionality is the same as noted in the previous step. The spline trace requires at least three points to draw the trace. Continue setting the points of the trace until the desired points are set. 6. Press Set again after the last caliper is fixed to finalize the spline trace. All points are removed from the line and the spline trace turns yellow. NOTE: Pressing Set twice finishes the trace measurement. If Clear is pressed twice when more than 3 points exist on the trace, all points are removed and the first caliper again displays. NOTE: 2-22 Spline trace is not available through the factory default. The system defaults to trace. To enable spline trace, modify the Measure Key Sequence preset found in Utility -> Measure -> Advanced preset menu. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 Measurement and Analysis Circumference and area (spline trace) measurement (continued) Edit the spline trace 1. Select Cursor Select. The spline trace changes to green and all points appear on the trace as yellow. A pick-caliper appears on the center of the image and the message “Edit spline trace” displays at the bottom of the screen. NOTE: The pick-caliper is used to select and move the trace points. Figure 2-3. NOTE: Edit spline trace Pressing Clear at this time removes all points and the trace graphic. 2. Move the pick-caliper to the desired point and press Set. The point is activated and turns green. 3. Move the point to the desired position and press Set. The point is fixed and turns yellow. The pick-caliper appears on the center of the image. NOTE: The spline trace is updated at run time. NOTE: To remove a point, press Clear while moving the point. The trace turns green and the remaining points continue to be shown as yellow. If there are less than three points, the spline trace is removed. 4. Press Set again. All points are removed from the trace and the trace is shown as yellow. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 2-23 Performing an Exam Doppler Mode Measurements Four basic measurements can be made in Doppler Mode. NOTE: • Velocity • TAMAX and TAMEAN (Manual or Auto Trace) • Two Velocities with the Time Interval and Acceleration between them • Time Interval • Volume Flow The following instructions assume that you do the following: 1. In the B-Mode part of the display, scan the anatomy you want to measure. 2. Go to the Doppler Mode part of the display. 3. Press Freeze. Velocity To measure velocity: 1. Press Measure; an active caliper with a vertical dotted line displays. 2. To position the caliper at the desired measurement point, move the Trackball. 3. To complete the measurement, press Set. The system displays the velocity measurement in the Results Window. 2-24 LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 Measurement and Analysis TAMAX and TAMEAN Manual Trace The value measured depends upon the Vol Flow Method preset. The two selections available are: Peak (TAMAX) and Mean (TAMEAN). To do a manual trace of TAMAX or TAMEAN: 1. Press Measure. Press the appropriate Trackball key to select Manual Trace; a trace caliper displays. 2. To position the caliper at the trace start point, move the Trackball. 3. To fix the start point, press Set. 4. To trace the maximum values of the desired portion of the spectrum, move the Trackball. NOTE: To edit the trace line, move the Trackball. 5. To complete the measurement, press Set. The system displays the measurement values in the Results Window. Auto Trace The value measured depends upon the Vol Flow Method preset. The selection available is the Peak (TAMAX). To auto trace TAMAX: 1. Press Measure. Press the appropriate Trackball key to select Auto Trace; an active caliper with a vertical dotted line displays. 2. To position the caliper at the trace start point in the Doppler spectrum, move the Trackball. 3. To fix the start point, press Set. 4. To position the vertical caliper at the end point, move the Trackball. 5. To complete the measurement, press Set. The system automatically fixes both calipers and traces the maximum value between the two points. The system displays this value in the Results Window. NOTE: When you set the Auto Trace for Both (above and below), the system picks up the maximum power of the signal, NOT the maximum velocity. If the maximum velocity is not the maximum power, the system may not trace accurately. If you want to use maximum velocity, select either Above or Below. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 2-25 Performing an Exam Velocity, Time Interval and Acceleration To measure two velocity values, the time interval (ms), and acceleration (m/s2): 1. Press Measure. Press the appropriate Trackball key to select Slope; an active caliper with vertical and horizontal dotted lines displays. 2. To position the caliper at the start point, move the Trackball. 3. To fix the start point, press Set. The system fixes the first caliper and displays a second active caliper. 4. To position the second caliper at the end point, move the Trackball. 5. To complete the measurement, press Set. The system displays the two peak end point velocities, the time interval, and the acceleration in the Results Window. Time interval To measure a horizontal time interval: 1. Press Measure. Press the appropriate Trackball key to select Time; an active caliper with vertical and horizontal dotted lines displays. 2. To position the active caliper at the start point, move the Trackball. 3. To fix the start point, press Set. The system fixes the first caliper and displays a second active caliper. 4. To position the second caliper at the end point, move the Trackball. 5. To complete the measurement, press Set. The system displays the time interval between the two calipers in the Results Window. 2-26 LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 Measurement and Analysis M-Mode Measurements Basic measurements that can be taken in the M-Mode portion of the display are: NOTE: • Tissue Depth (Distance) • Time Interval • Time Interval and Velocity The following instructions assume that you do the following: 1. In the B-Mode part of the display, scan the anatomy you want to measure. 2. Go to the M-Mode part of the display. 3. Press Freeze. Tissue depth Tissue depth measurement in M-Mode functions the same as distance measurement in B-Mode. It measures the vertical distance between calipers. 1. Press Measure; an active caliper with a vertical and horizontal dotted line displays. 2. To position the active caliper at the most anterior point you want to measure, move the Trackball. 3. To fix the start point, press Set. The system fixes the first caliper and displays a second active caliper. 4. To position the second caliper at the most posterior point you want to measure, move the Trackball. 5. To complete the measurement, press Set. The system displays the vertical distance between the two points in the Results Window. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 2-27 Performing an Exam Time interval To measure a horizontal time interval and velocity: 1. Press Measure. Press the appropriate Trackball key to select Time; an active caliper with vertical and horizontal dotted lines displays. 2. To position the caliper at the start point, move the Trackball. 3. To fix the first caliper, press Set. The system fixes the first caliper and displays a second active caliper. 4. To position the second caliper at the end point, move the Trackball. 5. To complete the measurement, press Set. The system displays the time interval between the two calipers in the Results Window. Time interval and Velocity To measure time and velocity between two points: 1. Press Measure. Press the appropriate Trackball key to select Slope; an active caliper with vertical and horizontal dotted lines displays. 2. To position the active caliper at the start point, move the Trackball. 3. To fix the start point, press Set. The system fixes the first caliper and displays a second active caliper. 4. To position the second caliper at the end point, move the Trackball. 5. To complete the measurement, press Set. The system displays time(s) and slope between the two points in the Results Window. 2-28 LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 Measurement and Analysis Viewing and Editing Worksheets NOTE: Worksheets are not saved if the system crashes. As you complete measurements, the system puts measurement data in the appropriate worksheets. To view a worksheet To view a worksheet, select Worksheet on the Touch Panel. The system displays the worksheet for the current study. Figure 2-4. OB B-Mode Worksheet To return to scanning, do one of the following: • Select Worksheet. • Press Esc. • Select the Exit button. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 2-29 Performing an Exam To view a worksheet (continued) To view a different worksheet, select the worksheet key for the desired worksheet. Figure 2-5. Worksheet Display Touch Panel To view worksheet data for a particular mode, select the key for that mode. To view a worksheet with data for more than one mode, select Expand. When Expand is selected, it defaults to view all measurements, noted by mode, on the worksheet. If a worksheet has more data on a second page, to view the next page, adjust the Page Change control. 2-30 LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 Measurement and Analysis To edit a worksheet To change data on a worksheet: 1. To position the cursor at the field you want to change, move the Trackball. The field is highlighted. 2. Press Set. 3. Type the new data in the field. The new data is displayed in blue to indicate that it was manually entered. To delete or exclude data on a worksheet: 1. To position the cursor at the field you want to delete or exclude, move the Trackball. The field is highlighted. 2. Do one of the following: • To delete the field, select Delete Value. • To exclude the field, select Exclude Value. The data in the field is not visible and is not included in worksheet calculations. • To include a value that you previously excluded, select Exclude Value. To type a comment on a worksheet: 1. Select Examiner’s Comments. The Examiner’s Comments window opens. 2. Type comments about the exam. 3. To close the Examiner’s Comments window, select Examiner’s Comments. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 2-31 Performing an Exam To edit a worksheet (continued) To turn the volume measurement value off: • Select the method type Off. The value field becomes blank. Figure 2-6. Volume Parameter Off HINTS 2-32 Some fields on the worksheet are view only, and others you can change or select. To easily see which fields you can change or select, move the Trackball. As the cursor moves over a field that you can change or select, the field is highlighted. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 Measurement and Analysis Delete All Worksheet Values You can delete all worksheet values on a worksheet. 1. When the Worksheet is displayed on the monitor, press the Clear key; the following warning message appears: Figure 2-7. Delete All Warning Message 2. Select OK to delete all. Select Cancel to cancel the deletion. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 2-33 Performing an Exam Clinical Measurement Accuracy Basic Measurements The following information is intended to provide guidance to the user in determining the amount of variation or measurement error that should be considered when performing clinical measurements with this equipment. Error can be contributed by equipment limitations and improper user technique. Be sure to follow all measurement instructions and develop uniform measurement techniques among all users to minimize the potential operator error. Also, in order to detect possible equipment malfunctions that could affect measurement accuracy, a quality assurance (QA) plan should be established for the equipment that includes routine accuracy checks with tissue mimicking phantoms. Please be advised that all distance and Doppler related measurements through tissue are dependent upon the propagation velocity of sound within the tissue. The propagation velocity usually varies with the type of tissue, but an average velocity for soft tissue is assumed. This equipment is designed for, and the accuracy statements listed on are based on, an assumed average velocity of 1540 m/s. The percent accuracy when stated applies to the measurement obtained (not the full scale range). Where the accuracy is stated as a percent with a fixed value, the expected inaccuracy is the greater of the two. 2-34 LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 Measurement and Analysis Basic Measurements (continued) Table 2-6: Measurement Units System Measurements and Accuracies Useful Range Accuracy Limitations or Conditions mm Full Screen ±20% Axial mm Full Screen ±3%, not to exceed 1mm Lateral mm Full Screen ±5%, not to exceed 1mm Linear Probes Lateral mm Full Screen ±6.5%, not to exceed 3.5 mm Convex Probes Lateral mm Full Screen ±5%, not to exceed 1mm Sector Probes Trace mm Full Screen ±5%, not to exceed 1mm Ellipse mm Full Screen ±5%, not to exceed 1mm Trace mm2 Full Screen ±10% or 5 mm2 Ellipse mm2 Full Screen ±10% or 5 mm2 Depth Distance: Circumference: Area: ±13% Static 3D/4D Volume Accuracy Time s Timeline Display ±5%, not to exceed 10ms M or Doppler Mode Slope mm/s Timeline Display ±5%, not to exceed 1mm/s M-Mode Only Doppler Sample Volume Depth (SVD) mm Full Screen 2mm (0.2cm) in any direction When SVD is at least half the depth of the image Velocity cm/s Full Range 10% PW and CW Doppler Mode Doppler Angle Correction degrees From 0-59° From 60-90° ±1% ±2% LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 2-35 Performing an Exam Setting up the Off-Line Paper Printer You can connect an off-line paper printer via the USB port on the rear of the system. CAUTION DO NOT place an off-line paper printer inside the patient environment (within the dotted line area noted by “1” in Figure 2-8). Refer to the off-board printer’s manual for details. Peripheral devices that use their own AC power source CANNOT be attached to the LOGIQ E9. DO NOT connect the peripheral device’s power cord into the LOGIQ E9 system. Figure 2-8. CAUTION 2-36 Patient Environment Use a USB printer cable that is less than 3 meters in length. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 Chapter 3 After the Exam is Over Probe Overview, System Presets, DataBackup, Configuring Connectivity, Electronic Documentation and System Care and Maintenance LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 3-1 After the Exam is Over Probe Overview Probe Naming Conventions Table 3-1: Real Time 4D “R” 3-2 Probe Naming Convention Type Application C=Convex L=Linear M=Matrix S=Sector AB=Abdominal IC=Intracavitary NA=Neonatal SP=Small Parts Frequency “1-5” Connector Type D=DLP LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 Probe Overview Probe handling and infection control This information is intended to increase user awareness of the risks of disease transmission associated with using this equipment and provide guidance in making decisions directly affecting the safety of the patient as well as the equipment user. Diagnostic ultrasound systems utilize ultrasound energy that must be coupled to the patient by direct physical contact. Depending on the type of examination, this contact occurs with a variety of tissues ranging from intact skin in a routine exam to recirculating blood in a surgical procedure. The level of risk of infection varies greatly with the type of contact. One of the most effective ways to prevent transmission between patients is with single use or disposable devices. However, ultrasound transducers are complex and expensive devices that must be reused between patients. It is very important, therefore, to minimize the risk of disease transmission by using barriers and through proper processing between patients. CAUTION Risk of Infection. ALWAYS clean and disinfect the probe between patients to the level appropriate for the type of examination and use FDA-cleared probe sheaths where appropriate. CAUTION Adequate cleaning and disinfection are necessary to prevent disease transmission. It is the responsibility of the equipment user to verify and maintain the effectiveness of the infection control procedures in use. Always use sterile, legally marketed probe sheaths for intra-cavitary and intra-operative procedures. For neurological intra-operative procedures, use of a legally marketed, sterile, pyrogen free probe sheath is REQUIRED. Probes for neuro surgical use must not be sterilized with liquid chemical sterilants because of the possibility of neuro toxic residues remaining on the probe. CAUTION Devices containing latex may cause severe allergic reaction in latex sensitive individuals. Refer to FDA's March 29, 1991 Medical Alert on latex products. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 3-3 After the Exam is Over Endocavitary Probe Handling Precautions If the sterilization solution comes out of the endocavitary probe, please follow the cautions below. CAUTION Sterilant Exposure to Patient (e.g., Cidex)—Contact with a sterilant to the patient’s skin or mucous membrane may cause an inflammation. If this happens, refer to the sterilant’s instruction manual. Sterilant Exposure from Probe Handle to Patient (e.g., Cidex)—DO NOT allow the sterilant to contact the patient. Only immerse the probe to its specified level. Ensure that no solution has entered the probe’s handle before scanning the patient. If sterilant comes into contact with the patient, refer the the sterilant’s instruction manual. Sterilant Exposure from Probe Connector to Patient (e.g., Cidex)—DO NOT allow the sterilant to contact the patient. Only immerse the probe to its specified level. Ensure that no solution has entered the probe’s connector before scanning the paitent. If sterilant comes into contact with the patient, refer the the sterilant’s instruction manual. Endocavitary Probe Point of Contact—Refer to the sterilant’s instruction manual. 3-4 LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 Probe Overview Probe Cleaning Process Cleaning probes Perform After Each Use To clean the probe: 1. Disconnect the probe from the ultrasound console and remove all coupling gel from the probe by wiping with a soft cloth and rinsing with flowing water. 2. Wash the probe with mild soap in lukewarm water. Scrub the probe as needed using a soft sponge, gauze, or cloth to remove all visible residue from the probe surface. Prolonged soaking or scrubbing with a soft bristle brush (such as a toothbrush) may be necessary if material has dried onto the probe surface. CAUTION Take extra care when handling the lens face of the Ultrasound transducer. The lens face is especially sensitive and can easily be damaged by rough handling. NEVER use excessive force when cleaning the lens face. 3. Rinse the probe with enough clean potable water to remove all visible soap residue. 4. Air dry or dry with a soft cloth. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 3-5 After the Exam is Over Cleaning probes (continued) Figure 3-1. Probe Immersion Levels 1. Fluid Level 3-6 LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 Probe Overview Disinfecting probes Perform After Each Use Ultrasound probes can be disinfected using liquid chemical germicides. The level of disinfection is directly related to the duration of contact with the germicide. Increased contact time produces a higher level of disinfection. Table 3-2: Pictogram Description of Pictogram on Care card Description “ATTENTION” - Consult accompanying documents” is intended to alert the user to refer to the operator manual or other instructions when complete information cannot be provided on the label. “CAUTION” - Dangerous voltage” (the lightning flash with arrowhead) is used to indicate electric shock hazards. Biohazard - Patient/user infection due to contaminated equipment. Usage • Cleaning and care instructions • Sheath and glove guidelines Ultrasound probes are highly sensitive medical instruments that can easily be damaged by improper handling. Use care when handling and protect from damage when not in use. Do not immerse the probe into any liquid beyond the level specified for that probe. Refer to the user manual of the ultrasound system. Since there is a possibility of having negative effects on the probe, observe the specified immersing time by the germicide manufacturer strictly. Do not immerse the probe in liquid chemical germicides more than the time prescribed in the care card. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 3-7 After the Exam is Over Disinfecting probes (continued) CAUTION Review the probe care card that is packed with each probe. The following website contains the most current and up-to-date recommendations: http://www.gehealthcare.com/usen/ultrasound/products/ probe_care.html Disinfectant Probe Disinfectants 9L-D 11L-D ML6-15-D L8-18i-D M4S-D M5S-D S1-5 S4-10 C1-5-D M6C-D 3CRF IC5-9-D RNA5-9-D RAB2-5-D RAB4-8-D RIC5-9-D RSP6-16-D 6S-D 6Tc P2D P6D Table 3-3: Anios X Aniosyme DD1 X Anioxyde 1000 X Asepti-Wipes X X X Asepti-Wipes II X X X X X X X X Cavi Wipes X X X X X X X X Cidex X X X X X X X X X X X X X X X X X Cidex OPA X X X X X X X X X X X X X X X X X X Cidex Plus X X X X X X X X X X X Cidezymel Enzol Cleanisept wipes X X X X X X X X X X X X X X X X X X X DisOPA X Gigasept X Gigasept AF X Gigasept FF Gigasept FF neu X X X X X X X X 3-8 X X X X X X X X X X X X X Hexanios G+R Hibitane X X X X X X X LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 Probe Overview Disinfectant Probe Disinfectants (Continued) 9L-D 11L-D ML6-15-D L8-18i-D M4S-D M5S-D S1-5 S4-10 C1-5-D M6C-D 3CRF IC5-9-D RNA5-9-D RAB2-5-D RAB4-8-D RIC5-9-D RSP6-16-D 6S-D 6Tc P2D P6D Table 3-3: Incidin Foam X Korsolex Extra X Klenzyme X X X X Metricide X Metricide 14 X X X X X X X X X X X X X X X X X Metricide OPA Plus X X X X X X X X X X MetriWipes MetriZyme X X X X X X X X X Milton X X X X X X Nu-Cidex X PeraSafe X X X X X Protex X X X X X RelyOn MDC (Virkon) X X X X X X X X X X X X X X X X X Sani-Cloth Active X X Sani-Cloth Germicidal X X X X X X X X X X X X X X X X X X X X Sekusept Aktiv X Sekusept Plus Septiwipes X X Salvanios pH7 Sani-Cloth HB X X X X X X X X X X Sporox X Sporox II X X X Ster Bac Blu LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 X X X X X X X X X X X X 3-9 After the Exam is Over Disinfectant Probe Disinfectants (Continued) 9L-D 11L-D ML6-15-D L8-18i-D M4S-D M5S-D S1-5 S4-10 C1-5-D M6C-D 3CRF IC5-9-D RNA5-9-D RAB2-5-D RAB4-8-D RIC5-9-D RSP6-16-D 6S-D 6Tc P2D P6D Table 3-3: Super Sani-Cloth X TD-100 and TD-5 X Transeptic Spray X X X Tristel Generator Solution X X X X X X X X T-Spray X X X X X X X X X X X X X X X X X T-Spray II X X X X X Wavicide-01 X X X X X X X X X X X X X X X X X 3-10 X X X X X X X X X X X X X LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 Probe Overview Disinfecting probes (continued) CAUTION In order for liquid chemical germicides to be effective, all visible residue must be removed during the cleaning process. Thoroughly clean the probe, as described earlier before attempting disinfection. You MUST disconnect the probe from the LOGIQ E9 prior to cleaning/disinfecting the probe. Failure to do so could damage the system. DO NOT soak probes in liquid chemical germicide for longer than is stated by the germicide instructions for use. Extended soaking may cause probe damage and early failure of the enclosure, resulting in possible electric shock hazard. 1. Prepare the germicide solution according to the manufacturer's instructions. Be sure to follow all precautions for storage, use and disposal. 2. Place the cleaned and dried probe in contact with the germicide for the time specified by the germicide manufacturer. High-level disinfection is recommended for surface probes and is required for endocavitary and intraoperative probes (follow the germicide manufacturer's recommended time). CAUTION Probes for neuro surgical intra-operative use must NOT be sterilized with liquid chemical sterilants because of the possibility of neuro toxic residues remaining on the probe. Neurological procedures must be done with the use of legally marketed, sterile, pyrogen free probe sheaths. 3. After removing from the germicide, rinse the probe following the germicide manufacturer's rinsing instructions. Flush all visible germicide residue from the probe and allow to air dry. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 3-11 After the Exam is Over Disinfecting probes (continued) CAUTION CREUTZFIELD-JACOB DISEASE Neurological use on patients with this disease must be avoided. If a probe becomes contaminated, there is no adequate disinfecting means. Biological Hazard WARNING Ultrasound transducers can easily be damaged by improper handling and by contact with certain chemicals. Failure to follow these precautions can result in serious injury and equipment damage. • Do not immerse the probe into any liquid beyond the level specified for that probe. Never immerse the transducer connector or probe adapters into any liquid. • Avoid mechanical shock or impact to the transducer and do not apply excessive bending or pulling force to the cable. • Transducer damage can result from contact with inappropriate coupling or cleaning agents: • 3-12 • Do not soak or saturate transducers with solutions containing alcohol, bleach, ammonium chloride compounds or hydrogen peroxide • Avoid contact with solutions or coupling gels containing mineral oil or lanolin • Avoid temperatures above 60°C. Inspect the probe prior to use for damage or degeneration to the housing, strain relief, lens and seal. Do not use a damaged or defective probe. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 Probe Overview Coupling gels WARNING Do not use unrecommended gels (lubricants). They may damage the probe and void the warranty. Probe Gels Gel 9L-D 11L-D ML6-15-D L8-18i-D M4S-D M5S-D S1-5 S4-10 C1-5-D M6C-D 3CRF IC5-9-D RNA5-9-D RAB2-5-D RAB4-8-D RIC5-9-D RSP6-16-D 6S-D 6Tc P2D P6D Table 3-4: Aquasonics 100 X X X X X X X X X X X X X X X X X Clear Image X X X X X X X X GE Ultrasound Contact Gel HAIYIN Gel X X X X X X X X X X X X X Incidin Foam Kendall X X X X X X Natural Image X X X X Scan X X X X X Sonogel X X X X X X X X X X X X X X X X X Wavelength X X X X X Applying CAUTION X X X X X X X X X X X X In order to assure optimal transmission of energy between the patient and probe, a conductive gel or couplant must be applied liberally to the patient where scanning will be performed. Do not apply gel to the eyes. If there is gel contact to the eye, flush eye thoroughly with water. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 3-13 After the Exam is Over Precautions 3-14 Coupling gels should not contain the following ingredients as they are known to cause probe damage: • Methanol, ethanol, isopropanol, or any other alcohol-based product • Mineral oil • Iodine • Lotions • Lanolin • Aloe Vera • Olive Oil • Methyl or Ethyl Parabens (para hydroxybenzoic acid) • Dimethylsilicone • Polyether glycol based LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 Probe Overview Biopsy Special Concerns WARNING Do not freeze the image during a biopsy procedure. The image must be live to avoid a positioning error. Biopsy guidezones are intended to assist the user in determining optimal probe placement and approximate the needle path. However, actual needle movement is likely to deviate from the guideline. Always monitor the relative positions of the biopsy needle and the subject mass during the procedure. CAUTION The use of biopsy devices and accessories that have not been evaluated for use with this equipment may not be compatible and could result in injury. CAUTION The invasive nature of biopsy procedures requires proper preparation and technique to control infection and disease transmission. Equipment must be cleaned as appropriate for the procedure prior to use. CAUTION • Follow the probe cleaning and disinfection procedures and precautions to properly prepare the probe. • Follow the manufacturer's instructions for the cleaning of biopsy devices and accessories. • Use protective barriers such as gloves and probe sheaths. • After use, follow proper procedures for decontamination, cleaning, and waste disposal. Improper cleaning methods and the use of certain cleaning and disinfecting agents can cause damage to the plastic components that will degrade imaging performance or increase the risk of electric shock. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 3-15 After the Exam is Over Displaying the Guidezone Activate the Biopsy Kit by selecting it from the B-Mode Touch Panel. The available biopsy options appear when Biopsy Kit is selected. There are fixed and adjustable angle biopsy kits and plastic/disposable and reusable biopsy guides available with the LOGIQ E9 depending on the probe. Select the desired biopsy kit. WARNING Biopsy procedures must only be performed on live images. DANGER Failure to match the guidezone displayed to the guide may cause the needle to track a path outside the zone. It is extremely important that when using the adjustable angle biopsy guides, the angle displayed on the screen matches the angle set on the guide, otherwise the needle will not follow the displayed guidezone which could result in repeated biopsies or patient injury. CAUTION 3-16 Please refer to the manufacturer's instructions included in the biopsy kit. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 Probe Overview Surgery/Intra-operative Use Preparing the transducer for intra-operative use follows the same sterile procedure as for biopsy use except that no biopsy attachments are used. Sterile gel is applied to the transducer face and a sterile sheath completely covers the transducer and cable which has first undergone a thorough cleaning and high-level disinfection. CAUTION For surgery/intra-operative procedures, a sterile environment is required. Therefore, both the operator and probe needs to be sterile. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 3-17 After the Exam is Over System Presets Foreign Language Keyboard Setup Keyboard Setup for non-Russian/Greek Languages To set up the keyboard for non-Russian/Greek languages: NOTE: You must apply the changes on each setup page before moving to the next page. 1. In Utility--> System--> General, set the Language as desired. Save this setting, but do not reboot the system yet. 2. Press Regional Options, select the Language tab, press Details, under Installed Services press Add to set the Keyboard layout/IME to United States-International, press OK, set the Default input language to English (United States) - United States International, press Apply, Press OK. Figure 3-2. Selecting the International Keyboard 3-18 LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 System Presets Keyboard Setup for non-Russian/Greek Languages (continued) 3. Select the Advanced tab, then select the language in the Language for non-Unicode programs pull-down menu. Press Apply. Answer Yes to use files already loaded on the hard disk, then answer No to not reboot the system yet, press OK. Press Save and Exit the Utility screen. Figure 3-3. Set Language 4. Reboot the system. When your system restarts, the system appears in the selected language. 5. To type foreign characters, press Alt+Shift to change the keyboard to the international keyboard, then press the Alt GR+appropriate keyboard key. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 3-19 After the Exam is Over Keyboard Setup Procedure for Russian and Greek 1. In Utility--> System--> General, set the Language as Russian or Greek. Save this setting, but do not reboot the system yet. Figure 3-4. Changing the System Language to Russian/Greek 3-20 LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 System Presets Keyboard Setup Procedure for Russian and Greek (continued) 2. Press Regional Options, under Standards and Formats select Russian or Greek, under Location select Russia or Greece. Press Apply. Figure 3-5. Regional Options 3. Select the Language tab, press Details, under Installed Services select the Russian or Greek keyboard, under Default input language select Russian - Russian or Greek Greek, press Apply, Press OK. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 3-21 After the Exam is Over Keyboard Setup Procedure for Russian and Greek (continued) 4. Select the Advanced tab, then select Russian or Greek in the Language for non-Unicode programs pull-down menu. Press Apply. Answer Yes to use files already loaded on the hard disk, then answer No to not reboot the system yet, press OK. Press Save and Exit the Utility screen. Figure 3-6. Set Language 5. Reboot the system. When your system restarts, the system appears in the selected language. 6. To switch between the English and Russian (or Greek) keyboard, press Alt+Shift to change the keyboard to the Russian or Greek keyboard. 7. Apply the changes by pressing Apply. Press OK TWICE. NOTE: 3-22 To have the settings take effect, you MUST turn off the system and turn it back on. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 System Presets Keyboard Setup Procedure for Russian and Greek (continued) Here is an example of the Russian keyboard: Figure 3-7. Russian Keyboard Here is an example of the Greek keyboard: Figure 3-8. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 Greek Keyboard 3-23 After the Exam is Over Data Backup EZBackup and EZMove EZBackup or EZMove allows you to manage hard disk space (move images off the hard drive) while maintaining the patient database on the scanner, as well as to back up the patient database and images. HINTS PLEASE READ THIS Ensure that you have established a data management protocol for your office/institution. You MUST manage the backup media by keeping a log and by creating a media filing system. For example, if you need to back up 500 MB/day, or 2.5 GB/ week, then you need to back up 5 CDs/week, or ~250CDs/ year. Generally speaking, you should back up the system when you have 10 GB of images to back up. You should assign the person who is in charge of performing the backups. Backups will vary by the volume of your work. You need to track how long it takes your office/institution to get to 10 GB, and set the back-up parameters accordingly. Your office/institution needs to determine your backup strategy, for instance, backup weekly and move monthly. It should be an easy strategy to perform and to remember. And follow this same strategy/schedule consistently. It’s also useful to keep your more recent information on the hard drive since it’s easier to recall that way. GE Healthcare IS NOT responsible for lost data if you do not follow suggested back-up procedures. GE Healthcare WILL NOT aid in the recovery of lost data. 3-24 LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 Data Backup EZBackup and EZMove (continued) CAUTION DO NOT use DVD-RAM for EZBackup and EZMove. Use a CD-R, DVD-R, or USB Hard Drive for EZBackup and EZMove. CAUTION If you use EZBackup or EZMove as a “true” patient archive, you must maintain a separate backup of the patient database (Patient Archive and Report Archive). If for any reason the Local Archive - Int HD gets corrupted or the base system software has to be reloaded, then the patient archive is the ONLY way to rebuild the EZBackup and EZMove patient archive. CAUTION After copying the image file to the media, EZMove deletes the image file from the Local HD. EZBackup does not back up the exams which were previously backed up once by EZBackup or Export. If you want to back up those exams by EZBackup again, select “Full Backup Option” on the EZBackup wizard. Even when “Full backup” is selected, the system only backs up the exams within the range specified in the Utility -> System -> Backup/Restore -> Backup Files Older Than in Days preset. CAUTION Disconnect the USB HDD when performing EZMove on the system. • DO NOT use the internal hard drive for long-term image storage. Daily backup is recommended. External storage media is recommended for image archive. • You need to set up a process for locating images stored to external storage media for easy recall LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 3-25 After the Exam is Over EZBackup and EZMove (continued) Basically, when you perform the EZBackup or EZMove procedure, you insert the media (or connect USB HDD if applicable), the system backs up/moves the images (or reports), and creates a reference between the patient database and the media’s volume. 1. Prepare unformatted media or the USB HDD before starting EZBackup/EZMove. NOTE: BEFORE starting the EZBackup, select “Unlock All” in Utility --> Admin --> Logon. 2. Specify the EZBackup/EZMove setup on the Utility --> System --> Backup/Restore page. 3. To start the EZBackup/EZMove procedure, go to the Patient menu and select EZBackup/EZMove. The EZBackup/ EZMove Wizard starts. NOTE: EZBackup/EZMove can take up to 20 minutes (or longer, depending on the size of the backup). Make sure to schedule this at the same time daily, when no patients are scheduled. 4. Verify the information on the first page of the EZBackup/ EZMove Wizard, then press Next. Full backup options display on the first page of the EZBackup wizard. If you want to backup all of the exams in the range (even if the exam was previously backed up, check this option). NOTE: You can set the range in Utility --> System --> Backup/ Restore --> Move files older than in days. If you uncheck this option, the system only backs up exams which have not yet been backed up. NOTE: 3-26 If you update an exam which is already backed up, the exam is also backed up. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 Data Backup EZBackup and EZMove (continued) NOTE: You do not need to format the media prior to performing an EZBackup/EZMove. You cannot use formatted media for EZBackup/EZMove. NOTE: EZBackup/EZMove cannot span a single image across two (2) or more media. Therefore, if EZBackup/EZMove encounters an image that is greater than the capacity of the media, it skips the oversized image. NOTE: EZBackup/EZMove does not store images to media in sequential order. Instead it maximizes the most amount of images per media. NOTE: The calculation for the number of backup CDs is only an estimate. Allow for one additional CD when performing an EZBackup/EZMove. NOTE: If you use the USB HDD, some wizards and the pop-up messages DO NOT appear. 5. Verify the information on the EZBackup/EZMove Wizard, Page 2. The backup may span multiple media. This page tells you how many media you need to do this backup. After you have gathered the media (allow for one extra media, just in case), you are ready to begin the backup. Press Next. Free Space/Total Size: tells you the size of the data you have selected to store/and the total size of the USB Hard Drive storage media. If the storage capacity of the USB HD is insufficient, you will see the message, “Selected Location does not have enough free space.” LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 3-27 After the Exam is Over EZBackup and EZMove (continued) 6. A pop-up message appears that provides you with the media label. Label the media, then insert the media. Press OK. a. Ensure that you label the media with not only the volume name indicated on the Insert Media Message, but with the name of the LOGIQ E9 system where this backup/move procedure was done. b. Update the EZBackup/EZMove log with this information the volume information and the location of the media. c. NOTE: You can cancel the backup/move at any time. The system completes backing up the current media and then cancels the operation. NOTE: If the system locks up during the media auto format process, shutdown the system by holding down the power button and boot it up again. After the system is up, replace the media to a new one and execute EZBackup or EZMove again. To avoid data loss, do not reuse the failed media for any other function. CAUTION NOTE: 3-28 After the backup/move has been completed, file the media. Only cancel the backup/move in case of an emergency. This message appears if you press Next without inserting the backup media: “Please insert a blank media...”. Insert the media and continue. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 Data Backup EZBackup and EZMove (continued) 7. The status menu appears. When the backup/move has been completed, press Next. NOTE: When/if you need to insert the next media, a message appears providing you with the media label. Label the media, then insert the next media and press OK. 8. When the backup is complete, the completed wizard page appears. Press Finish. 9. Do a patient archive after each EZBackup/EZMove (move). NOTE: Use Import to restore EZBackup images. CAUTION NEVER restore the patient archive from media made previous to the last move. You can still do a backup/move daily; but ALWAYS do a patient archive backup after each move. WARNING DO NOT use the USB Hard Disk Drive for patient storage. The USB HDD is not considered a permanent storage device. If you connect the USB HDD to a virus-infected computer, the USB HDD may also be infected with a computer virus. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 3-29 After the Exam is Over To View Backed Up/Moved Images You can view backed up media via the Patient Menu or Import. 1. Select the patient on the Patient Menu (on the same system where the backup/move was performed). 2. Insert the media volume indicated on the Patient Menu. 3. View the exam from the media. 3-30 NOTE: You may need to insert a media volume prior to or after the recommended media. NOTE: If the patient is split over multiple media, images on the previous or next media are displayed as triangles. NOTE: To view the whole patient on the system, use Import, from as many media as you have for that patient. However, take care not to import studies over existing studies; duplicate or missing images may result. Delete the existing exam first. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 Data Backup Backup procedure: user-defined configurations CAUTION To avoid the risk of overwriting the local patient and report archives on the system to update, DO NOT check Patient Archive when making a backup of configuration settings. Figure 3-9. System/Backup/Restore Preset Menu 1. Insert media into the media drive. 2. On the Touch Panel, press Utility. 3. On the Utility Touch Panel, press System. 4. On the monitor display, select Backup/Restore. The Backup/Restore screen is displayed. NOTE: If you are not logged in with administrator privileges, the Operator Login window is displayed. Log on with administrator privileges. 5. In the Backup list, select User Defined Configuration. 6. In the Media field, select a media. 7. Select Backup. The system performs the backup. As it proceeds, status information is displayed on the Backup/Restore screen. 8. After the backup is complete, press F3 to eject the CD. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 3-31 After the Exam is Over Restore procedure: patient data CAUTION The restore procedure overwrites the existing database on the local hard drive. Make sure to insert the correct media. You cannot restore the data between systems with different software versions. 1. Insert the media into the media drive. 2. On the Touch Panel, press Utility. 3. On the Utility Touch Panel, press System. 4. On the monitor display, select Backup/Restore. The Backup/Restore screen is displayed. NOTE: If you are not logged in with administrator privileges, the Operator Login window is displayed. Log on with administrator privileges. 5. In the Restore list, select Patient Archive. 6. In the Media field, select the media. 7. Select Restore. The system performs the restore. As it proceeds, status information is displayed on the Backup/Restore screen. 3-32 LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 Data Backup Restore procedure: user-defined configurations CAUTION The restore procedure overwrites the existing database on the local hard drive. Make sure to insert the correct media. CAUTION To avoid the risk of overwriting the local patient and report archives, DO NOT check Patient Archive when restoring user-defined configurations. 1. Insert the media with the user-defined configurations into the drive. 2. On the Touch Panel, press Utility. 3. On the Utility Touch Panel, press System. 4. On the monitor display, select Backup/Restore. The Backup/Restore screen is displayed. NOTE: If you are not logged in with administrator privileges, the Operator Login window is displayed. Log on with administrator privileges. 5. In the Restore list, select from the following, depending on which configurations you want to restore: • User Defined Configuration OR • Select the parameters to be restored in the Detailed Restore section. 6. In the Media field, select the media. 7. Select Restore. The system performs the restore. As it proceeds, status information is displayed on the System/Backup/Restore screen. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 3-33 After the Exam is Over Configuring Connectivity Overview You use Connectivity functionality to set up the connection and communication protocols for the ultrasound system. The following page gives an overview of each of the Connectivity functions. Each function is described in detail in the following pages. 3-34 LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 Configuring Connectivity Connectivity Functions To set up your institution’s connectivity, you must login with administrator privileges. 1. TCPIP: allows you to configure the Internet Protocol. 2. Device. allows you to set up devices. 3. Service: allows you to configure a service (for example, DICOM services such as printers, worklist, and other services such as video print and standard print) from the list of supported services. This means that the user can configure a device with the DICOM service(s) that particular device supports. 4. Dataflow: allows you to adjust the settings of the selected dataflow and associated services. Selecting a dataflow customizes the ultrasound system to work according to the services associated with the selected dataflow. 5. Button: allows you to assign a pre-configured output service (or a set of output services) to the Print keys on the control panel. 6. Removable Media: enables formatting (DICOM, database, or blank formatting) and DICOM verification of removable media. 7. Miscellaneous: allows you to set up the patient exam menu options, print and store options, and the order of the columns in the examination list on the Patient menu. Configure these screens from left to right, starting with the Tcpip tab first. NOTE: CAUTION The ultrasound system is pre-configured for many services, with default settings selected. You can change these services and settings as needed. You must restart the LOGIQ E9 (shutdown) after making any changes to connectivity settings in the Utility menus. This includes any changes on the TCPIP or dataflow setup screens. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 3-35 After the Exam is Over Anti-Virus Software Note Anti-virus software IS NOT present on the LOGIQ E9 system. Since the LOGIQ E9 is already protected against attack by the measures listed below, no Anti-virus software is deemed necessary. • Only communication ports required for system operation are enabled. • Only operating system services required by system application software are enabled. • Software programs CANNOT be loaded onto the LOGIQ E9 (e.g., email, web browser, etc.). • An auto-executable file CANNOT be run automatically on the LOGIQ E9. • The LOGIQ E9 software includes the latest MS Windows security protection. • Prior to release, the LOGIQ E9 is tested using the same tools as the United States Department of Defense and Hospital IT organizations. Due to the safety measures noted above, and the security standards of Windows XP Service Pack 3, the highest safety against viruses, worms, etc., has been provided to ensure sufficient safety measures. In addition, additional security information can be found at http://www.gehealthcare.com/usen/ security/index.html. 3-36 LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 Electronic Documentation Electronic Documentation Accessing Documentation Via a PC To view user documentation on a PC, 1. Insert the media into the media drive. 2. Open the media drive on your desktop. 3. Double click on the ‘gedocumentation.html’ document. 4. Select the item you want to view (click on the blue, underlined link in the File Name column). To close the window, click on the ‘X’ in the upper, right-hand corner of the browser window. NOTE: If your PC does not have Adobe Reader, a free download is available on the Adobe website at http://www.adobe.com. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 3-37 After the Exam is Over Accessing Documentation on the Ultrasound Scanner Via the media To access documentation via the media, 1. Select Utility. Select Service. Wait until the logon screen appears. 2. Logon as ‘Operator’ next to Select User Level. Enter the following password: ‘uls’. Press Okay. 3. Press Utilities. 4. Insert the media. 5. Select Common Utilities. 6. Select Scanner Documentation Interface. 7. Scroll to find the document and double click on it to open it. NOTE: You can search through a document, use hyperlinks in the Table of Contents and Index to locate topics, and navigate via bookmarks. NOTE: In addition to viewing documentation on the Ultrasound system, the Documentation media can be read on any PC. To exit, press the ‘X’ in the upper, right-hand corner of the documentation window. 3-38 LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 Electronic Documentation Using Online Help Via F1 Online Help is available via the F1 key. After pressing F1, Help appears. The Help screen is divided into three sections: navigational tools on the top, left portion of the screen (Hide, Back, Forward), help book navigational tools on the left portion of the screen (Contents, Index, Search, Favorites), and the content portion on the right side of the screen where help topics are displayed. Figure 3-10. Opening Help Screen Exiting Online Help To exit Online Help, press the ‘X’ in the upper, right-hand corner of the Online Help window. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 3-39 After the Exam is Over Contact Information 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 USA Clinical Questions GE Healthcare TEL: (1) 800-437-1171 Ultrasound Service Engineering FAX: (1) 414-721-3865 9900 Innovation Drive Wauwatosa, WI 53226 For information in the United States, Canada, Mexico and parts of the Caribbean, call the Customer Answer Center TEL: (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 TEL: (1) 800-437-1171 In other locations, contact your local Service Representative. 3-40 LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 Contact Information Contacting GE Healthcare Ultrasound (continued) Accessories Catalog Requests To request the latest GE Accessories catalog or equipment brochures in the United States, call the Response Center TEL: (1) 800-643-6439 In other locations, contact your local Applications, Sales or Service Representative. Placing an Order To place an order, order supplies or ask an accesory-related question in the United States, call the GE Access Center TEL: (1) 800-472-3666 In other locations, contact your local Applications, Sales or Service Representative. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 3-41 After the Exam is Over Contacting GE Healthcare Ultrasound (continued) CANADA GE Healthcare TEL: (1) 800-668-0732 Ultrasound Service Engineering 9900 Innovation Drive Wauwatosa, WI 53226 Customer Answer Center TEL: (1) 262-524-5698 LATIN & SOUTH AMERICA GE Healthcare TEL: (1) 262-524-5300 Ultrasound Service Engineering 9900 Innovation Drive Wauwatosa, WI 53226 Customer Answer Center TEL: (1) 262-524-5698 EUROPE ASIA PACIFIC JAPAN AUSTRALIA NEW ZEALAND SINGAPORE KOREA GE Ultraschall TEL: 0130 81 6370 toll free Deutschland GmbH & Co. KG TEL: (33) 130.831.300 Beethovenstrasse 239 FAX: (49) 212.28.02.431 Postfach 11 05 60 D-42655 Solingen GE Healthcare Asia Pacific Tokyo, Japan TEL: +81 42 585 5111 Sydney, Australia TEL: +61 2 9846 4000 Australia TEL: 1 300 722 229 New Zealand TEL: 0800 434 274 Singapore TEL: +65 6291 8528 Central Plaza #12-01/06 Singapore 168730 Seoul, Korea TEL: +82 2 6201 3114 www.gehealthcare.com 3-42 LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 Contact Information Contacting GE Healthcare Ultrasound (continued) ARGENTINA GEME S.A. TEL: (1) 639-1619 Miranda 5237 FAX: (1) 567-2678 Buenos Aires - 1407 AUSTRIA GE GesmbH Medical Systems Austria TEL: 0660 8459 toll free Prinz Eugen Strasse 8/8 FAX: +43 1 505 38 74 A-1040 WIEN TLX: 136314 BELGIUM GE Healthcare BVBA TEL: +32 0 2 719 72 04 Kouterveldstraat 20 FAX: +32 0 2 719 72 05 B-1831 Diegem BRAZIL GE Sistemas Medicos TEL: 0800-122345 Av Nove de Julho 5229 FAX: (011) 3067-8298 01407-907 Sao Paulo SP CHINA DENMARK FRANCE GERMANY GREECE GE Healthcare - Asia TEL: (8610) 5806 9403 No. 1, Yongchang North Road FAX: (8610) 6787 1162 Beijing Economic & Technology Development Area Beijing 100176, China GE Medical Systems TEL: +45 4348 5400 Fabriksparken 20 FAX: +45 4348 5399 DK-2600 GLOSTRUP GE Medical Systems TEL: 05 49 33 71 toll free 738 rue Yves Carmen FAX: +33 1 46 10 01 20 F-92658 BOULOGNE CEDEX GE Ultraschall TEL: 0130 81 6370 toll free Deutschland GmbH & Co. KG TEL: (49) 212.28.02.207 Beethovenstrasse 239 FAX: (49) 212.28.02.431 Postfach 11 05 60 D-42655 Solingen GE Medical Systems Hellas TEL: +30 1 93 24 582 41, Nikolaou Plastira Street FAX: +30 1 93 58 414 G-171 21 NEA SMYRNI LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 3-43 After the Exam is Over Contacting GE Healthcare Ultrasound (continued) ITALY LUXEMBOURG MEXICO NETHERLANDS POLAND PORTUGAL RUSSIA SPAIN SWEDEN 3-44 GE Medical Systems Italia TEL: 1678 744 73 toll free Via Monte Albenza 9 FAX: +39 39 73 37 86 I-20052 MONZA TLX: 3333 28 TEL: 0800 2603 toll free GE Sistemas Medicos de Mexico S.A. de C.V. Rio Lerma #302, 1° y 2° Pisos TEL: (5) 228-9600 Colonia Cuauhtemoc FAX: (5) 211-4631 06500-Mexico, D.F. GE Medical Systems Nederland B.V. TEL: 06 022 3797 toll free Atoomweg 512 FAX: +31 304 11702 NL-3542 AB UTRECHT GE Medical Systems Polska TEL: +48 2 625 59 62 Krzywickiego 34 FAX: +48 2 615 59 66 P-02-078 WARSZAWA GE Medical Systems Portuguesa S.A. TEL: 05 05 33 7313 toll free Rua Sa da Bandeira, 585 FAX: +351 2 2084494 Apartado 4094 TLX: 22804 P-4002 PORTO CODEX GE VNIIEM TEL: +7 495 739 6931 18C, Krasnopresnenskaya nab. FAX: +7 495 739 6932 MOSCOW 123317 TLX: 613020 GEMED SU GE Healthcare TEL: +34 (91) 663 25 00 Edificio Gobelas I FAX: +34 (91) 663 25 01 C/ Gobelas 35-37 E- 28023-Madrid GE Medical Systems TEL: 020 795 433 toll free PO-BOX 1243 FAX: +46 87 51 30 90 S-16428 KISTA TLX: 12228 CGRSWES LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 Contact Information Contacting GE Healthcare Ultrasound (continued) SWITZERLAND TURKEY UNITED KINGDOM OTHER COUNTRIES GE Medical Systems (Schweiz) AG TEL: 155 5306 toll free Sternmattweg 1 FAX: +41 41 421859 CH-6010 KRIENS GE Healthcare Turkiye TEL: +90 212 366 29 00 Sun Plaza FAX: +90 212 366 29 99 Dereboyu Sok. No 24/7 34398 Maslak ISTANBUL GE Medical Systems TEL: 0800 89 7905 toll free Coolidge House FAX: +44 753 696067 352 Buckingham Avenue SLOUGH Berkshire SL1 4ER NO TOLL FREE TEL: international code + 33 1 39 20 0007 Manufacturer GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC DBA GE Healthcare 9900 Innovation Drive Wauwatosa, WI 53226 U.S.A LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 3-45 After the Exam is Over System Care and Maintenance Expected Service Life Description The expected service life for the LOGIQ E9 system and probes is identified in this table: Table 3-5: Equipment / Accessory Expected Service Life Expected Service Life LOGIQ E9 system The expected service life for the LOGIQ E9 is at least seven (7) years from the manufacturing date under the provision of regular maintenance by authorized service personnel. LOGIQ E9 Probes The expected service life for the LOGIQ E9 probes meets or exceeds five (5) years from the date the probe is placed in service, under the provision that the customer follows the care instructions provided on the Probe Care Card / Accompanying LOGIQ E9 Instructions for Use. 3-46 LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 System Care and Maintenance Inspecting the System Examine the following on a monthly basis: CAUTION Electrical Hazard • Connectors on cables for any mechanical defects. • Entire length of electrical and power cables for cuts or abrasions. • Equipment for loose or missing hardware. • Control panel and keyboard for defects. • Casters for proper locking operation. To avoid electrical shock hazard, do not remove panels or covers from console. This servicing must be performed by qualified service personnel. Failure to do so could cause serious injury. If any defects are observed or malfunctions occur, do not operate the equipment but inform a qualified service person. Contact a Service Representative for information. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 3-47 After the Exam is Over Weekly Maintenance The system requires weekly care and maintenance to function safely and properly. Clean the following: • LCD • Operator control panel • B/W Printer • CD/DVD-R Multi Drive • Filters (weekly, or as needed) • Footswitch Failure to perform required maintenance may result in unnecessary service calls. System Cabinet To clean the system cabinet: 1. Moisten a soft, non-abrasive folded cloth with a mild, general purpose, non-abrasive soap and water solution. 2. Moisten a soft, non-abrasive folded cloth. 3. Wipe down the top, front, back, and both sides of the system cabinet. NOTE: Do not spray any liquid directly into the unit. Touch Panel For the Touch Panel, use a non-ammonia (isopropyl and water) lens cleaner. These are available at most computer outlet stores. DO NOT use Windex, Screen-Clean, etc. as these contain ammonia, which will remove the anti-glare coating on the Touch Panel. 3-48 LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 System Care and Maintenance Operator Controls Cleaning Agents ONLY use the following cleaners on the LOGIQ E9 Operator Panel: • Palmolive Dishwashing Liquid (manufactured by Colgate-Palmolive) • Sani Wipes Alcohol-free (manufactured by Micorgen Inc.) • T-Spray II (manufactured by Pharmaceutical Innovations, Inc.) DO NOT USE: • Original T-Spray (T-Spray I) • SaniCloth Plus (red cap); Use Sani-Cloth HB (green cap) instead. • Any cleaning/disinfecting solution containing Alcohol. NOTE: When cleaning the operator control panel, make sure not to spill or spray any liquid on the controls, into the system cabinet, or in the probe connection receptacle. NOTE: In case of SARS, use bleach or Cidex in a normal diluted form for cleaning/disinfecting the operator panel. NOTE: DO NOT use T-Spray I or Sani Wipes on the control panel. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 3-49 After the Exam is Over Cleaning Instructions To clean the operator control panel: 1. Lock the Operator Panel controls via the Keyboard Lock rotary on the Utility Touch Panel. NOTE: After pressing Keyboard Lock, the following pop-up message appears. 2. Moisten a soft, non-abrasive folded cloth with a mild, general purpose, non-abrasive soap and water solution. 3. Wipe down operator control panel. 4. Use a cotton swab to clean around keys or controls. Use a toothpick to remove solids from between keys and controls. 3-50 LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 System Care and Maintenance LCD Monitor NOTE: Never use thinner, benzene, alcohol (ethanol, methanol, or isopropyl alcohol), abrasive cleaners, or other strong solvents, as these may cause damage to the cabinet or LCD panel. NOTE: DO NOT scratch or press on the panel with any sharp objects, such as pencils or pens, as this may result in damage to the panel. To clean the cabinet: • To remove stains, wipe the cabinet with a soft, lightly moistened cloth using a mild detergent. Do not spray wax or cleaner directly into the cabinet. To clean LCD panel: • The LCD surface can be cleaned with a soft cloth, such as cotton or lens paper. • If necessary, stubborn stains can be removed by moistening part of a cloth with water to enhance its cleaning power. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 3-51 After the Exam is Over Other Maintenance Manually Moving the Operator Panel Up/Down The LOGIQ E9 is equipped with an automatic Operator Panel up/down, left/right, forward/backward control. But if the system is powered down when you need to lower the Operator Panel, you can use the manual release handle located at the back of the unit to manually move the Operator Panel up/down. To move the Operator Panel up/down using the manual control, 1. Locate the manual release handle which extends through the air vent at the back of the LOGIQ E9. Figure 3-11. Manual release handle 2. Move the manual release handle to the left with one hand while pushing up/down on the Operator Panel to position it. 3-52 LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 System Care and Maintenance Cleaning the Air Filters Clean the system's air filters to ensure that a clogged filter does not cause the system to overheat and reduce system performance and reliability. It is recommended the filters be cleaned quarterly (once every three months). CAUTION Be sure to lock the wheels before cleaning the air filters to avoid injury by any unexpected movement of the system. Locating The LOGIQ E9 has two air filters which need to be cleaned. The top air filter (A) is located on the back of the LOGIQ E9 below the power cord and the bottom air filter (B) is located underneath the LOGIQ E9. Figure 3-12. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 Location of Air Filters 3-53 After the Exam is Over Cleaning the Air Filters (continued) Cleaning To clean the top air filter, 1. Gently remove the filter cover. Pull the cover out and away from the LOGIQ E9. Set it down. 2. Remove the foam filter. 3. Clean the foam filter with soap and water. Let dry. 4. Replace the filter. 5. Replace the filter cover. Position it back into place on the back of the LOGIQ E9. The bottom filter is held in place with magnets. To clean the bottom air filter, 1. You need to kneel down on the floor to access the bottom filter. Locate the metal handle extending from the air filter on the bottom of the LOGIQ E9. 2. You may need two hands to remove this filter. One hand is used to pull on the piece of cloth that extends from the filter and the other hand is used to wedge a finger just under a corner of the filter. In this step, firmly take hold of the metal handle that extends from the filter. 3. Position your other hand at a corner of the filter and wedge a finger between the filter and the bottom of the LOGIQ E9. 4. Pull down on the filter with the finger that is wedged between the filter and the LOGIQ E9 while pulling on the metal handle that extends from the filter at the same time to remove the filter. 5. Clean this filter with soap and water. Let dry. 6. Reposition the filter at the bottom of the LOGIQ E9. 3-54 LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 System Care and Maintenance Supplies/Accessories CAUTION DO NOT connect any probes or accessories without approval by GE. Not all features or products described in this document may be available or cleared for sale in all markets. Contact the distributor, GE affiliate or sales representative for approved peripherals. For HCATs, contact your sales person. For 2million/5million number part numbers, these are service replacement part numbers that may be either new or refurbished. To order these, contact CARES in the US, or call service in Europe and Asia. The following supplies/accessories have been verified to be compatible with the system: Peripherals Table 3-6: Peripherals and Accessories Accessory Part Number / HCAT Sony B/W Printer Model UP-D897 5171608 Sony Color Printer Model UP-D23MD 2401985 / H4903JS Sony Color Printer Model UP-D25MD 5389822 / H4911JT Sony Color Printer Model UP-D55 5116559 HP470 Report Printer 5322258 / H4908RP HP470 Report Printer USB Cable 5315370 LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 3-55 After the Exam is Over Console Table 3-7: Console Accessories Accessory Part Number / HCAT Protective Cover H4908DC Remote Display with Adapter H4910SM LOGIQ E9 Technical Course H4908TC Swedish Keyboard H4908SY Norwegian Keyboard H4908NY Greek Keyboard H4908GY Russian Keyboard H4908RY Power Cord - North American H4000ZA / 5148381 Power Cord - Argentina H4000ZH / 5148381-9 Power Cord - Europe H4000ZB / 5148381-3 Power Cord - UK-Ireland H4000ZD / 5148381-4 Power Cord - Switzerland H4000ZL / 5148381-7 Power Cord - Denmark H4000ZE / 5148381-8 Power Cord - Israel H4000ZJ / 5148381-10 Power Cord - Japan H4000ZK / 5148381-2 Power Cord - China H4000ZC / 5148381-5 Power Cord - Australia H4000ZG / 5323129 Power Cord - India H4000ZF / 5148381-11 3-56 LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 System Care and Maintenance Probes Table 3-8: Probe 3CRF Micro Convex HCAT Global P/N Japan P/N H40442LP Probes and Accessories Biopsy Guide Biopsy Guide HCAT Single Angle, Disposable with a Reusable Bracket H40442LR Multiline Starter Kit H78122PA Multi Biopsy H40452LP Multi Spare Screw H40452LR Multi 13, 14, 15G H40452LS Multi 16, 17, 18, 19G H40452LT Multi 20, 21, 22, 23G H40452LW V Nav Capable V Nav Bracket HCAT Yes H40452LK C1-5 Convex H40452LE Multi Angle, Disposable with a Reusable Bracket H40432LE Yes H40432LF M6C-D Matrix Array Convex H40432LM Multi Angle, Disposable with a Reusable Bracket E8385RF No N/A IC5-9-D Micro Convex Intracavitary H40442LK Single Angle E8385MJ H40412LN No N/A Disposable with a Plastic Bracket or IC59_TR5 Reusable with a Stainless Steel Bracket IC59_RU S1-5 Sector H4908SC Multi Angle, Disposable with a Reusable Bracket H4908SD Yes H4908ND S4-10 Sector H4908SN Not Available N/A Yes H4908NN M4S-D Sector H40442LN Not Available N/A No N/A M5S-D Sector H45551NH Not Available N/A Yes H4908NM 6S-D Sector H45021RR Not Available N/A No N/A L8-18i-D H40452LL Not Available N/A Yes H4908NH LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 3-57 After the Exam is Over Table 3-8: Probe HCAT Global P/N Japan P/N Probes and Accessories (Continued) Biopsy Guide Biopsy Guide HCAT V Nav Capable V Nav Bracket HCAT 9L-D Linear H40442LM Multi Angle, Disposable with a Reusable Bracket H4906BK Yes H4908NB 11L-D Linear H40432LN Multi Angle, Disposable with a Reusable Bracket H40432LC No N/A ML6-15-D Matrix Array Linear H40452LG Multi Angle, Disposable with a Reusable Bracket H40432LJ Yes H40432LK RAB2-5-D 4D Convex Volume H48651MN Single Angle, Disposable with a Reusable Bracket Single Angle, Reusable H4601AE No N/A N/A H48621W RAB4-8-D 4D Convex Volume H48651MP Same Brackets as RAB2-5-D H46701AE H48621W No RIC5-9-D 4D Convex Volume Intracavitary H48651MS Single Angle, Reusable H46721R No RNA5-9-D 4D Convex Volume H48651MY Single Angle, Disposable with a Reusable Bracket Single Angle, Reusable H46701AF No Single Angle, Disposable with a Reusable Bracket H47001AD Single Angle, Reusable H46721W Starter Kit H46701AD RSP6-16-D 4D Linear Volume H48651MR H468651DG No P2D CW Split Crystal Pencil Probe H4830JE Not Available N/A No N/A P6D CW Split Crystal Pencil Probe H4830JG Not Available N/A No N/A 6Tc Transesophageal Probe H45551ZD Not Available N/A No N/A 3-58 LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 System Care and Maintenance Options Table 3-9: Options Option Part Number / HCAT LOGIQView H4908LW DICOM H4908DM Report Writer H4908RW Realtime 4D H4908D 4D with VCI H4908MD VOCAL II (Volume Calculation) H4908HL Contrast Imaging (Not available in the USA)* H4908C Volume Contrast Imaging (VCI) (Not available in the USA) H4908HM Volume Navigation with Stand H4908N Volume Navigation without Stand H4908NA Scan Assistant H4908SA Tomographic Ultrasound Imaging H4908TM DVR H4908DR Footswitch, USB H4910FT / 5331575 ECG H4910EG Continuous Wave (CW) H4910CW / H4911CW Wireless Lan (WLAN) H4910WR / 5340249 Elastography H4910E Auto IMT H4910MT Tissue Velocity Imaging (TVI) H4910TY External Monitor (Remote Display with Adapter) H4910SM Quantification Elastography: H4911EN Color and PDI Mode: H4911CN LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 3-59 After the Exam is Over Table 3-9: Options (Continued) Option Part Number / HCAT Stress Echo H4911SE Video Scan Converter H4911SC *The LOGIQ E9 is designed for compatibility with commercially available Ultrasound contrast agents. Because the availability of these agents is subject to government regulation and approval, product features intended for use with these agents may not be commercially marketed nor made available before the contrast agent is cleared for use. Contrast-related product features are enabled only on systems for delivery to an authorized country or region of use. 3-60 LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 System Care and Maintenance Gel Table 3-10: Gel Accessory Units Thermasonic Gel Warmer Holds three plastic bottles (250ml or 8 oz) Aquasonic 100 Scan Gel 5 liter jug 250 ml plastic bottles (12/ case) Scan Ultrasound Gel 8 oz plastic bottles (12/ case) 1 gallon plastic jug Four 1-gallon plastic jugs Disinfectant Table 3-11: Disinfectant Accessory Units Cidex Activated Dialdehyde 16/1 quart bottles 4/1 gallon bottles 2/2.5 gallon bottles LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 3-61 After the Exam is Over Ultrasound Probe and Cord Sheath Sets Table 3-12: Probe and Cord Sheath Sets Accessory Units Sterile Ultrasound Probe Sheath Set 20 Per Set Sterile Ultrasound Cord Sheath Set 20 Per Set Sanitary Rectal/Vaginal Probe Cover 20 Per Set Sterile Combination Probe and Cord Cover Set 12 Per Set Sterile Ultrasound Probe Sheath Set for Wide (2.5 and 3.5) Aperture Sector Probes 20 Per Set 3-62 LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 Chapter 4 Safety Describes the safety and regulatory information pertinent for operating this ultrasound system. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 4-1 Safety Safety Precautions Precaution Levels Icon description Various levels of safety precautions may be found on the equipment and different levels of concern are identified by one of the following flag words and icons which precede the precautionary statement. DANGER WARNING CAUTION NOTE: 4-2 Indicates that a specific hazard is known to exist which through inappropriate conditions or actions will cause: • Severe or fatal personal injury • Substantial property damage. Indicates that a specific hazard is known to exist which through inappropriate conditions or actions may cause: • Severe personal injury • Substantial property damage. Indicates that a potential hazard may exist which through inappropriate conditions or actions will or can cause: • Minor injury • Property damage. Indicates precautions or recommendations that should be used in the operation of the ultrasound system, specifically: • Maintaining an optimum system environment • Using this Manual • Notes to emphasize or clarify a point. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 Safety Precautions Hazard Symbols Icon Description Potential hazards are indicated by the following icons: Table 4-1: Icon Potential Hazards Potential Hazard Usage • Patient/user infection due to contaminated equipment. • Cleaning and care instructions • Sheath and glove guidelines • Electrical micro-shock to patient, e.g., ventricular • Probes • ECG, if applicable • Connections to back panel • Console, accessories or optional storage devices that can fall on patient, user, or others. • Collision with persons or objects may result in injury while maneuvering or during system transport. • Injury to user from moving the console. • Moving • Using brakes • Transporting • Patient injury or tissue damage from ultrasound radiation. • ALARA, the use of Power Output following the ‘as low as reasonably achievable’ principle • Risk of explosion if used in the presence of flammable anesthetics. • Flammable anesthetic • Patient/user injury or adverse reaction from fire or smoke. • Patient/user injury from explosion and fire. • Replacing fuses • Outlet guidelines LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 Source ISO 7000 No. 0659 4-3 Safety Important Safety Considerations The following topic headings (Patient Safety, and Equipment and Personnel Safety) are intended to make the equipment user aware of particular hazards associated with the use of this equipment and the extent to which injury can occur if precautions are not observed. Additional precautions may be provided throughout the manual. CAUTION Improper use can result in serious injury. The user must be thoroughly familiar with the instructions and potential hazards involving ultrasound examination before attempting to use the device. Training assistance is available from GE Medical Systems if needed. The equipment user is obligated to be familiar with these concerns and avoid conditions that could result in injury. Disregarding information on safety is considered abnormal use. 4-4 LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 Safety Precautions Patient Safety Related Hazards WARNING The concerns listed can seriously affect the safety of patients undergoing a diagnostic ultrasound examination. Patient identification Always include proper identification with all patient data and verify the accuracy of the patient's name and ID numbers when entering such data. Make sure correct patient ID is provided on all recorded data and hard copy prints. Identification errors could result in an incorrect diagnosis. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 4-5 Safety Diagnostic information The images and calculations provided by the system are intended for use by competent users, as a diagnostic tool. They are explicitly not to be regarded as the sole, irrefutable basis for clinical diagnosis. Users are encouraged to study the literature and reach their own professional conclusions regarding the clinical utility of the system. The user should be aware of the product specifications and of the system accuracy and stability limitations. These limitations must be considered before making any decision based on quantitative values. If in doubt, the nearest GE Ultrasound Service Office should be consulted. Equipment malfunction or incorrect settings can result in measurement errors or failure to detect details within the image. The equipment user must become thoroughly familiar with the equipment operation in order to optimize its performance and recognize possible malfunctions. Applications training is available through the local GE representative. Added confidence in the equipment operation can be gained by establishing a quality assurance program. WARNING DO NOT touch the patient and any of the connectors on the ultrasound unit simultaneously, including ultrasound probe connectors. DO NOT touch the conducting parts of the USB, Ethernet, Video, Audio cables when connecting equipment to the unit. CAUTION 4-6 Be certain to ensure privacy data of patient information. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 Safety Precautions Mechanical hazards The use of damaged probes or improper use and manipulation of intracavity probes can result in injury or increased risk of infection. Inspect probes often for sharp, pointed, or rough surface damage that could cause injury or tear protective barriers. Never use excessive force when manipulating intracavity probes. Become familiar with all instructions and precautions provided with special purpose probes. The use of damaged probes can result in injury or increased risk of infection. Inspect probes often for sharp, pointed, or rough surface damage that could cause injury or tear protective barriers. Become familiar with all instructions and precautions provided with special purpose probes. Electrical Hazard A damaged probe can also increase the risk of electric shock if conductive solutions come in contact with internal live parts. Inspect probes often for cracks or openings in the housing and holes in and around the acoustic lens or other damage that could allow liquid entry. Become familiar with the probe's use and care precautions outlined in Probes and Biopsy. CAUTION Ultrasound transducers are sensitive instruments which can easily be damaged by rough handling. Take extra care not to drop transducers and avoid contact with sharp or abrasive surfaces. A damaged housing, lens or cable can result in patient injury or serious impairment or operation. CAUTION Do not use with Defibrillator. This equipment does not have a defibrillator approved applied part. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 4-7 Safety Scanner and electrosurgical units CAUTION This equipment provides no special means of protection from high frequency (HF) burns that may result from using an electrosurgical unit (ESU). To reduce the risk of HF burns, avoid contact between the patient and ultrasound transducer while operating the ESU. Where contact cannot be avoided, as in the case of TEE monitoring during surgery, make sure the transducer is not located between the ESU active and dispersive electrodes and keep the ESU cables away from the transducer cable. CAUTION Ultrasound can produce harmful effects in tissue and potentially result in patient injury. Always minimize exposure time and keep ultrasound levels low when there is no medical benefit. Use the principle of ALARA (As Low As Reasonably Achievable), increasing output only when needed to obtain diagnostic image quality. Observe the acoustic output display and be familiar with all controls affecting the output level. See the Bioeffects section of the Acoustic Output chapter in the Advanced Reference Manual for more information. ALARA Training It is recommended that all users receive proper training in applications before performing them in a clinical setting. Please contact the local GE representative for training assistance. ALARA training is provided by GE Application Specialists. The ALARA education program for the clinical end-user covers basic ultrasound principles, possible biological effects, the derivation and meaning of the indices, ALARA principles, and examples of specific applications of the ALARA principle. 4-8 LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 Safety Precautions Equipment and Personnel Safety Related Hazards WARNING This equipment contains dangerous voltages that are capable of serious injury or death. If any defects are observed or malfunctions occur, stop operating the equipment and perform the proper action for the patient. Inform a qualified service person and contact a Service Representative for information. There are no user serviceable components inside the console. Refer all servicing to qualified service personnel only. WARNING Only approved and recommended peripherals and accessories should be used. All peripherals and accessories must be securely mounted to the LOGIQ E9. WARNING The LOGIQ E9 is not intended to be used as a data storage device; backup of the Patient and Image Database is your institution’s responsibility. GE is NOT responsible for any lost patient information or for lost images. DANGER The concerns listed below can seriously affect the safety of equipment and personnel during a diagnostic ultrasound examination. Explosion Hazard Risk of explosion if used in the presence of flammable anesthetics. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 4-9 Safety Related Hazards (continued) CAUTION This equipment provides no special means of protection from high frequency (HF) burns that may result from using an electrosurgical unit (ESU). To reduce the risk of HF burns, avoid contact between the patient and ultrasound transducer while operating the ESU. Where contact cannot be avoided, as in the case of TEE monitoring during surgery, make sure the transducer is not located between the ESU active and dispersive electrodes and keep the ESU cables away from the transducer cable. Electrical Hazard To avoid injury: CAUTION • Do not remove protective covers. No user serviceable parts are inside. Refer servicing to qualified service personnel. • To assure adequate grounding, connect the attachment plug to a reliable (hospital grade) grounding outlet (having equalization conductor ). • Never use any adaptor or converter of a three-prong-to-two-prong type to connect with a mains power plug. The protective earth connection will loosen. • Do not place liquids on or above the console. Spilled liquid may contact live parts and increase the risk of shock. • In North America a 220V installation requires the use of a center-tapped AC source. Peripheral devices that use their own AC power source CANNOT be attached to the LOGIQ E9. DO NOT connect the peripheral device’s power cord into the LOGIQ E9 system. Use a USB printer cable that is less than 3 meters in length. CAUTION 4-10 Do not use this equipment if a safety problem is known to exist. Have the unit repaired and performance verified by qualified service personnel before returning to use. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 Safety Precautions Related Hazards (continued) Smoke & Fire Hazard Biological Hazard The system must be supplied from an adequately rated electrical circuit. The capacity of the supply circuit must be as specified. For patient and personnel safety, be aware of biological hazards while performing invasive procedures. To avoid the risk of disease transmission: • Use protective barriers (gloves and probe sheaths) whenever possible. Follow sterile procedures when appropriate. • Thoroughly clean probes and reusable accessories after each patient examination and disinfect or sterilize as needed. Refer to Probes and Biopsy for probe use and care instructions. • Follow all infection control policies established by your office, department or institution as they apply to personnel and equipment. CAUTION Contact with natural rubber latex may cause a severe anaphylactic reaction in persons sensitive to the natural latex protein. Sensitive users and patients must avoid contact with these items. Refer to package labeling to determine latex content and FDA’s March 29, 1991 Medical Alert on latex products. CAUTION Allowing the machine to transmit acoustic output when the probe is not in use (or in its holder) can cause the transducer to build up heat. Always lower the acoustic power or freeze the image when not in use. The system auto freezes after two minutes of scanning if it detects no change in the image (after 6 minutes for contrast imaging). LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 4-11 Safety Related Hazards (continued) CAUTION When you move the Control Panel up/down with the monitor, place BOTH hands on the Control Panel. Touching other moving parts other than the Control Panel may cause personal injury. CAUTION To avoid injury or system damage, NEVER place any object or liquid on the operator panel. CAUTION Archived data is managed at the individual sites. Performing data backup (to any device) is recommended. CAUTION • Make sure to verify the media after writing of data, such as EZBackup, SaveAs or Export. • Before deleting a patient or image from the patient screen, make sure you have saved the data by EZBackup/Backup or Export and verify that the media transfer of data was successful. CAUTION 4-12 Do not unpack the LOGIQ E9. This must be performed by qualified service personnel only. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 Safety Precautions Related Hazards (continued) CAUTION To avoid skin burns in surgical use, do not place ECG electrodes in the current path between the Electrosurgical Unit (ESU) active and dispersive electrodes. Keep ESU cables away from ECG leads. CAUTION To minimize accidental loss of data, perform EZBackup and Backup on a regular basis. 1. First, perform EZBackup to save the images. 2. Next, perform Backup at Utility -> Backup/Restore. Enable the following checkboxes under Backup: • CAUTION Patient Archive • Report Archive • User defined configuration • Service DO NOT load non-system software on the system computer. Material Safe Data Rubber part Material: EPDM Where Used: Probe holder/Gel holder/Keyboard bumper/Front and Rear Foot Pedal/System bumper at the four corners LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 4-13 Safety Related Hazards (LCD Monitor) CAUTION • 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. • To avoid result of injury or system damage, NEVER place any object or liquid on the monitor, whether in the home or flip down/transport position. • DO NOT scratch or press on the panel with any sharp objects, such as a pencil or pen, as this may result in damage to the panel. • To avoid injury or damage, make sure nothing is within the range of motion before moving the monitor and monitor arm. This includes both objects and people. • Pay attention to the monitor arm position to avoid hitting it against anyone or anything. • Before moving the system to another location, be sure to lock LCD/LCD arm in transport position. • The LCD screen may have defective pixels. These pixels may appear as a slightly light or dark area on the screen. This is due to the characteristics of the panel itself, and not the product. • The backlight of the LCD panel has a fixed life span. When the screen becomes dark or begins to flicker, contact a qualified Service Representative for information. Related Hazards (Volume Navigation) WARNING 4-14 DO NOT use the Volume Navigation feature on any patient relying on life-sustaining electronic equipment, such as a pacemaker or defibrillator. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 Safety Precautions Device Labels Label Icon Description The following table describes the purpose and location of safety labels and other important information provided on the equipment. Table 4-2: Label/Icon Label Icons Purpose/Meaning Location Identification and Rating Plate Manufacturer’s name and address Rear Panel See ‘Warning Label Locations’ on page 4-39 for more information. Identification and Rating Plate Date of manufacture Rating Plate See ‘Warning Label Locations’ on page 4-39 for more information. Serial Number Rating Plate See ‘Warning Label Locations’ on page 4-39 for more information. Catalog Number Rating Plate See ‘Warning Label Locations’ on page 4-39 for more information. Used to indicate the degree of safety or protection. Rear panel United States only Prescription Requirement label Rear Panel See ‘Warning Label Locations’ on page 4-39 for more information. CE Mark Rear Panel See ‘Warning Label Locations’ on page 4-39 for more information. Authorized European Representative address Rear Panel See ‘Warning Label Locations’ on page 4-39 for more information. Type/Class Label LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 4-15 Safety Table 4-2: Label/Icon IP Code (IPX8) 4-16 Label Icons (Continued) Purpose/Meaning Location Use two people to transport system on inclines. This label also indicates the system weight. Rear Panel See ‘Warning Label Locations’ on page 4-39 for more information. Indicates the degree of protection provided by the enclosure per IEC60 529. Can be used in operating room environment. Footswitch Type BF Applied Part (man in the box) symbol is in accordance with IEC 60417-5333. Probe See ‘Warning Label Locations’ on page 4-39 for more information. Type BF Applied Part (man in the box with paddle) symbol is in accordance with IEC 60417-5334. Probe Type CF Applied Part (heart in the box) symbol is in accordance with IEC 60878-02-03. Probe Type CF Defib-Proof Applied Part (heart in the box with paddle) symbol is in accordance with IEC 60878-02-06. Probe “ATTENTION” - Consult accompanying documents” is intended to alert the user to refer to the operator manual or other instructions when complete information cannot be provided on the label. Control panel and inside of console See ‘Warning Label Locations’ on page 4-39 for more information. “General Warning Sign” Back Cover Probe Label See ‘Warning Label Locations’ on page 4-39 for more information. “Warning” - Dangerous voltage” (the lightning flash with arrowhead) is used to indicate electric shock hazards. Rear panel and inside of console LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 Safety Precautions Table 4-2: Label/Icon Label Icons (Continued) Purpose/Meaning Location “Mains OFF” indicates the power off position of the mains power breaker. See the Console Overview section for location information. “Mains ON” indicates the power on position of the mains power breaker. See the Console Overview section for location information. “ON” indicates the power on position of the power switch. CAUTION: This Power Switch DOES NOT ISOLATE Mains Supply. See the Console Overview section for location information. “Protective Earth” indicates the protective earth (grounding) terminal. Internal “Equipotentiality” indicates the terminal to be used for connecting equipotential conductors when interconnecting (grounding) with other equipment. Connection of additional protective earth conductors or potential equalization conductors is not necessary in most cases and is only recommended for situations involving multiple equipment in a high-risk patient environment to provide assurance that all equipment is at the same potential and operates within acceptable leakage current limits. An example of a high-risk patient would be a special procedure where the patient has an accessible conductive path to the heart such as exposed cardiac pacing leads. IEC60417-5021 Rear of console Alternating Current symbol is in accordance with IEC 60878-01-14. Rear Panel, Rating Plate, Circuit breaker label of console and front panel (if applicable). This symbol indicates that waste electrical and electronic equipment must not be disposed of as unsorted municipal waste and must be collected separately. Please contact an authorized representative of the manufacturer for information concerning the decommissioning of your equipment. Rear Panel See ‘Warning Label Locations’ on page 4-39 for more information. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 4-17 Safety Table 4-2: Label/Icon Label Icons (Continued) Purpose/Meaning Location DO NOT place a finger, hand or any object below the operator panel on the top cover of the console to avoid injury while you’re moving it up and down. On the movable up/down operator control panel to caution users to not place their hands in this location while lowering the operator panel. GOST Symbol. Russia Regulatory Country Clearance. Rear Panel See ‘Warning Label Locations’ on page 4-39 for more information. 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. Rear Panel See ‘Warning Label Locations’ on page 4-39 for more information. ETL Listing Mark Monogram Rear Panel See ‘Warning Label Locations’ on page 4-39 for more information. ISO 7010 - P007 Volume Navigation Pacemaker Warning V Nav Trasmitter Indicates the presence of hazardous substance(s) above the maximum concentration value. Maximum concentration values for electronic information products, as set by the People’s Republic of China Electronic Industry Standard SJ/T11364-2006, include the hazardous substances of lead, mercury, hexavalent chromium, cadmium, polybrominated biphenyl (PBB), and polybrominated diphenyl ether (PBDE). “20” indicates the number of years during which the hazardous substance(s) will not leak or mutate so that the use of this product will not result in any severe environmental pollution, bodily injury, or damage to any assets. 4-18 LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 Safety Precautions Table 4-2: Label/Icon Label Icons (Continued) Purpose/Meaning Location Indicates the presence of hazardous substance(s) above the maximum concentration value. Maximum concentration values for electronic information products, as set by the People’s Republic of China Electronic Industry Standard SJ/T11364-2006, include the hazardous substances of lead, mercury, hexavalent chromium, cadmium, polybrominated biphenyl (PBB), and polybrominated diphenyl ether (PBDE). “20” indicates the number of years during which the hazardous substance(s) will not leak or mutate so that the use of this product will not result in any severe environmental pollution, bodily injury, or damage to any assets. Probes How to lower LCD prior to transport Rear of the LCD monitor. See ‘Warning Label Locations’ on page 4-39 for more information. How to lock Operator Panel prior to transport Rear of the LCD monitor. See ‘Warning Label Locations’ on page 4-39 for more information. 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. Rear of the LCD monitor. See ‘Warning Label Locations’ on page 4-39 for more information. DO NOT push the system. Use the handle to push/pull the system, e.g., DO NOT use the LCD. Failure to do so may cause serious injury or system damage. Rear of the LCD monitor. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 4-19 Safety Label Icon Description (continued) Classifications Type of protection against electric shock Class I Equipment (*1) Degree of protection against electric shock Type BF Applied part (*2) (for PCG, Probes marked with BF symbol) Type CF Applied part (*3) (for ECG marked with CF symbol) Continuous Operation System is Ordinary Equipment (IPX0) Footswitch is IPX8 *1. Class I Equipment EQUIPMENT in which protection against electric shock does not rely on BASIC INSULATION only, but includes an earth ground. This additional safety precaution prevents exposed metal parts from becoming LIVE in the event of an insulation failure. *2. Type BF Applied Part TYPE BF APPLIED PART providing a specified degree of protection against electric shock, with particular regard to allowable LEAKAGE CURRENT. Table 4-3: Patient leakage current Type BF Equipment Normal Mode Single fault condition Less than 100 microA Less than 500 microA *3. Type CF Applied Part TYPE CF APPLIED PART providing a degree of protection higher than that for Type BF Applied Part against electric shock particularly regarding allowable LEAKAGE CURRENTS. Table 4-4: Patient leakage current 4-20 Type CF Equipment Normal Mode Single fault condition Less than 10 microA Less than 50 microA LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 Safety Precautions RoHS LOGIQ E9 Hazardous Substances The following product pollution control information is provided according to SJ/T11364-2006 Marking for Control of Pollution caused by Electronic Information Products. This symbol indicates the product contains hazardous materials in excess of the limits established by the Chinese standard SJ/ T11363-2006 Requirements for Concentration Limits for Certain Hazardous Substances in Electronic Information Products. The number in the symbol is the Environment-friendly Use Period (EFUP), which indicates the period during which the toxic or hazardous substances or elements contained in electronic information products will not leak or mutate under normal operating conditions so that the use of such electronic information 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 manual, and periodic maintenance schedules specified in Product Maintenance Procedures shall be followed strictly. Consummables or certain parts may have their own label with an EFUP value less than the product. Periodic replacement of those consummables 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. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 4-21 Safety Name and Concentration of Hazardous Substances Table 4-5: Table of hazardous substances' name and concentration for LOGIQ systems Hazardous substances' name Component Name Pb Hg Cd Cr (VI) PBB PBDE LCD Monitor X X O O O O Circuit Boards X O O O O X LCD Panel X X O O O O Ultrasound Probes X O O O O O Console Cabinet X O O X O O Operator Panel X O O X O O Card Rack X O O O O X Back End Processor X O O O O X System Covers O O O O O O O: Indicates that this toxic or hazardous substance contained in all of the homogeneous materials for this part is below the limit requirement in SJ/T11363-2006. X: Indicates that this toxic or hazardous substance contained in at least one of the homogeneous materials used for this part is above the limit requirement in SJ/T11363-2006 • 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. 4-22 LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 Safety Precautions EMC (Electromagnetic Compatibility) NOTE: This equipment generates, uses and can radiate radio frequency energy. The equipment may cause radio frequency interference to other medical and non-medical devices and radio communications. To provide reasonable protection against such interference, this product complies with emissions limits for a Group 1, Class A Medical Devices Directive as stated in EN 60601-1-2. However, there is no guarantee that interference will not occur in a particular installation. NOTE: If this equipment is found to cause interference (which may be determined by turning the equipment on and off), the user (or qualified service personnel) should attempt to correct the problem by one or more of the following measure(s): • reorient or relocate the affected device(s) • increase the separation between the equipment and the affected device • power the equipment from a source different from that of the affected device • consult the point of purchase or service representative for further suggestions. NOTE: The manufacturer is not responsible for any interference caused by using other than recommended interconnect cables or by unauthorized changes or modifications to this equipment. Unauthorized changes or modifications could void the users’ authority to operate the equipment. NOTE: To comply with the regulations on electromagnetic interference for a Class A FCC Device, all interconnect cables to peripheral devices must be shielded and properly grounded. Use of cables not properly shielded and grounded may result in the equipment causing radio frequency interference in violation of the FCC regulations. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 4-23 Safety EMC (Electromagnetic Compatibility) (continued) NOTE: Do not use devices which intentionally transmit RF Signals (cellular phones, transceivers, or radio controlled products) other than those supplied by GE (wireless microphone, broadband over power lines, for example) in the vicinity of the equipment as it may cause performance outside the published specifications. Keep the power to these type devices turned off when near this equipment. The medical staff in charge of this equipment is required to instruct technicians, patients, and other people who maybe around this equipment to fully comply with the above requirement. EMC Performance All types of electronic equipment may characteristically cause electromagnetic interference with other equipment, either transmitted through air or connecting cables. The term EMC (Electromagnetic Compatibility) indicates the capability of equipment to curb electromagnetic influence from other equipment and at the same time not affect other equipment with similar electromagnetic radiation from itself. Proper installation following the service manual is required in order to achieve the full EMC performance of the product. The product must be installed as stipulated in 4.2, Notice upon Installation of Product. In case of issues related to EMC, please call your service personnel. The manufacturer is not responsible for any interference caused by using other than recommended interconnect cables or by unauthorized changes or modifications to this equipment. Unauthorized changes or modifications could void the users’ authority to operate the equipment. 4-24 LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 Safety Precautions EMC Performance (continued) CAUTION Do not use devices which intentionally transmit RF signals (cellular phones, transceivers, or radio controlled products), other than those supplied by GE (wireless microphone, broadband over power lines, for example) unless intended for use with this system, in the vicinity of this equipment as it may cause performance outside the published specifications. Keep power to these devices turned off when near this equipment. Medical staff in charge of this equipment is required to instruct technicians, patients and other people who may be around this equipment to fully comply with the above regulation. Portable and mobile radio communications equipment (e.g. two-way radio, cellular/cordless telephones, wireless computer networks) should be used no closer to any part of this system, including cables, than determined according to the following method: Table 4-6: Portable and mobile radio communications equipment distance requirements Frequency Range: 150 kHz - 80 MHz 80 MHz - 800 MHz 800 MHz - 2.5 GHz Calculation Method: d=[3.5/V1] square root of P d = [3.5/E1] square root of P d = [7/E1] square root of P Where: d= separation distance in meters, P = rated power of the transmitter, V1=compliance value for conducted RF, E1 = compliance value for radiated RF If the maximum transmitter power in watts is rated The separation distance in meters should be 5 2.6 2.6 5.2 20 5.2 5.2 10.5 100 12.0 12.0 24.0 LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 4-25 Safety Notice upon Installation of Product Separation distance and effect from fixed radio communications equipment: field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast transmitter cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the ultrasound system is used exceeds the applicable RF compliance level as stated in the immunity declaration, the ultrasound system should be observed to verify normal operation. If abnormal operation is observed, additional measures may be necessary, such as re-orienting or relocating the ultrasound system or using an RF shielded examination room may be necessary. 1. Use either power supply cords provided by GE Medical Systems or ones designated by GE Medical Systems. Products equipped with a power source plug should be plugged into the fixed power socket which has the protective grounding conductor. Never use any adaptor or converter to connect with a power source plug (e.g. three-prong-to-two-prong converter). 2. Locate the equipment as far away as possible from other electronic equipment. 3. Be sure to use only the cables provided by or designated by GE Medical Systems. Connect these cables following the installation procedures (e.g. wire power cables separately from signal cables). 4. Lay out the main equipment and other peripherals following the installation procedures described in the Option Installation manuals. 4-26 LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 Safety Precautions General Notice 1. Designation of Peripheral Equipment Connectable to This Product. The equipment indicated in Chapter 18 can be hooked up to the product without compromising its EMC performance. Avoid using equipment not designated in the list. Failure to comply with this instruction may result in poor EMC performance of the product. 2. Notice against User Modification The user should never modify this product. User modifications may cause degradation in EMC performance. Modification of the product includes changes in: a. Cables (length, material, wiring, etc.) b. System installation/layout c. System configuration/components d. Securing system parts (cover open/close, cover screwing) 3. Operate the system with all covers closed. If a cover is opened for some reason, be sure to shut it before starting/ resuming operation. 4. Operating the system with any cover open may affect EMC performance. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 4-27 Safety Peripheral Update for EC countries The following is intended to provide the users in EC countries with updated information concerning the connection of the LOGIQ E9 to image recording and other devices or communication networks. The LOGIQ E9 has been verified for overall safety, compatibility and compliance with the following image recording devices: • Sony UP-D897 Digital Printer • Sony UP-D23 Digital Printer • Sony UP-D25 Digital Printer • Sony UP-D55 Digital Printer • Canon PIXMA MP610 Digital Printer • HP470 Report Printer • DVR • Drive Bay (for Tru3D and Volume Navigation) • USB Flash Drive (Memory Stick) • Hard Disk Drive The LOGIQ E9 has also been verified for compatibility, and compliance for connection to a local area network (LAN) via the rear panel Ethernet connection, provided the LAN components are IEC/EN 60950 compliant. A Wireless LAN option is available. The LOGIQ E9 may also be used safely while connected to devices other than those recommended above if the devices and their specifications, installation, and interconnection with the system conform to the requirements of IEC/EN 60601-1-1. 4-28 LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 Safety Precautions Peripheral Update for EC countries (continued) Accessory equipment connected to the analog and digital interfaces must be certified according to the respective IEC standards (i.e., IEC60950 for data processing equipment and IEC60601-1 for medical equipment). Furthermore, all complete configurations shall comply with the valid version of the system standard IEC60601-1-1. Everyone who connects additional equipment to the signal input part or signal output part of the LOGIQ E9 system configures a medical system, and is therefore responsible to ensure that the system complies with the requirements of the valid version of IEC60601-1-1. If in doubt, consult the technical service department or your local GE Healthcare representative. General precautions for installing an alternate on-board device would include: 1. The added device must have appropriate safety standard conformance and CE Marking. 2. The total power consumption of the added devices, which connect to the LOGIQ E9 and are used simultaneously, must be less than or equal to the rated supply of the LOGIQ E9. 3. There must be adequate heat dissipation and ventilation to prevent overheating of the device. 4. There must be adequate mechanical mounting of the device and stability of the combination. 5. Risk and leakage current of the combination must comply with IEC/EN 60601-1-1. 6. Electromagnetic emissions and immunity of the combination must conform to IEC/EN 60601-1-2. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 4-29 Safety Peripheral Update for EC countries (continued) General precautions for installing an alternate off-board, remote device or a network would include: 1. The added device(s) must have appropriate safety standard conformance and CE Marking. 2. The added device(s) must be used for their intended purpose having a compatible interface. 3. Signal or mains isolation devices and additional protective earth may be needed to assure compliance with IEC/ EN 60601-1-1. CAUTION 4-30 The connection of equipment or transmission networks other than as specified in the user instructions can result in an electric shock hazard or equipment malfunction. Substitute or alternate equipment and connections requires verification of compatibility and conformity to IEC/EN 60601-1-1 by the installer. Equipment modifications and possible resulting malfunctions and electromagnetic interference are the responsibility of the owner. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 Safety Precautions Declaration of Emissions This system is suitable for use in the following environment. The user must assure that it is used only in the electromagnetic environment as specified. Table 4-7: Declaration of Emissions Guidance and manufacturer’s declaration - electromagnetic emissions The system is intended for use in the electrmagnetic environment specified below. The user of the system should assure that it is used in such an environment. Emission Type Compliance Electromagnetic Environment RF Emissions CISPR 11 Group 1 This system uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. RF Emissions CISPR 11 Class A Harmonic Emissions IEC 61000-3-2 Class A Voltage Fluctuations/Flicker Emissions IEC 61000-3-3 Complies This system is suitable for use in all establishments, other than domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes, provided the following warning is heeded: WARNING: This system is intended for use by healthcare professionals only. This system may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures, such as re-orienting or relocating the system or shielding the location. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 4-31 Safety Declaration of Immunity This system is suitable for use in the following environment. The user must assure that the system is used according to the specified guidance and only in the electromagnetic environment listed. 4-32 LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 Safety Precautions Declaration of Immunity (continued) Table 4-8: Immunity Type Declaration of Immunity Equipment Capability Regulatory Acceptable Level IEC 61000-4-2 Static discharge (ESD) ± 9 kV contact ± 12 kV air ± 9 kV contact ± 12 kV air IEC 61000-4-4 Electrical fast transient/burst ± 2 kV for mains ± 2 kV for mains ± 1 kV for SIP/SOP ± 1 kV for SIP/SOP IEC 61000-4-5 Surge Immunity ± 1 kV differential ± 1 kV differential ± 2 kV common ± 2 kV common IEC 61000-4-11 Voltage dips, short interruptions and voltage variations on mains supply < 50T (> 95% dip) for 0.5 cycle; 400T (60 0ip) for 5 cycles; 700T (30 0ip) for 25 cycles; < 50T (>95% dip) for 5 sec < 50T (> 95% dip) for 0.5 cycle; 400T (60 0ip) for 5 cycles; 700T (30 0ip) for 25 cycles; < 50T (>95% dip) for 5 sec IEC 61000-4-8 Power frequency (50/60 Hz) magnetic field 6 A/m 6 A/m IEC 61000-4-6 Conducted RF 3 VRMS 150 kHz - 80 MHz 3 VRMS 150 kHz - 80 MHz IEC 61000-4-3 Radiated RF 3 V/m 80 MHz - 2.5 GHz 3 V/m 80 MHz - 2.5 GHz IEC 61000-3-2 Harmonic Disturbance Emissions IEC Limits 230Vac IEC 61000-3-3 Voltage Fluctuations Emissions IEC Limits 230Vac 50Hz, 100Vac 50Hz EMC Environment and Guidance Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Mains power quality should be that of a typical commercial and/or hospital environment. If the user requires continued operation during power mains interruptions, it is recommended that the system be powered from a UPS or a battery. NOTE: UT is the a.c. mains voltage prior to application of the test level. Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial and/or hospital environment. Separation distance to radio communication equipment must be maintained according to the method below. Interference may occur in the vicinity of equipment marked with the symbol: NOTE: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. If noise generated from other electronic equipment is near the probe’s center frequency, noise may appear on the image. Good power line isolation is required. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 4-33 Safety Patient Environmental Devices Figure 4-1. Patient Environmental Devices 1. Front Panel (Signal I/O Port, Power On/Off, USB Ports) 2. Peripheral Devices DVD Multi Drive (CD, DVD, DVR) Patient I/O (ECG, CW Probe Port) V Nav Connectors 3. Network/Disk Indicators 4. Probe Ports (4) Probe Ports with CW Option (5) 4-34 5. Imaging Probes 6. Wireless LAN 7. Power In/Out Power Line (AC~) Ground Line Power Cable with Protective Earth 8. Signals I/O Port (USB Ports, Network Connector, Audio In/Out, DVI Port Connector) LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 Safety Precautions Acceptable Devices The Patient Environmental devices shown on the previous page are specified to be suitable for use within the PATIENT ENVIRONMENT. CAUTION DO NOT connect any probes or accessories without approval by GE within the PATIENT ENVIRONMENT. See ‘Peripheral Update for EC countries’ on page 4-28 for more information. Unapproved Devices CAUTION DO NOT use unapproved devices. If devices are connected without the approval of GE, the warranty will be INVALID. Any device connected to the LOGIQ E9 must conform to one or more of the requirements listed below: 1. IEC standard or equivalent standards appropriate to devices. 2. The devices shall be connected to PROTECTIVE EARTH (GROUND). Accessories, Options, Supplies CAUTION Unsafe operation or malfunction may result. Use only the accessories, options and supplies approved or recommended in these instructions for use. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 4-35 Safety Acoustic Output Located on the upper right section of the system display monitor, the acoustic output display provides the operator with real-time indication of acoustic levels being generated by the system. See the Acoustic Output chapter in the Advanced Reference Manual for more information. This display is based on NEMA/AIUM Standards for Real-time Display of Thermal and Mechanic Acoustic Output Indices on Diagnostic Ultrasound Equipment. Acoustic Output Display Specifications The display consists of three parts: Thermal Index (TI), Mechanical Index (MI), and a relative Acoustic Output (AO) value. Although not part of the NEMA/AIUM standard, the AO value informs the user of where the system is operating within the range of available output. The TI and MI are displayed at all times. The TI display starts at a value of 0.0 and increments in steps of 0.1 The MI display values between 0 and 0.4 increment in steps of 0.01 and for values greater than 0.4, increments in steps of 0.1. Thermal Index Depending on the examination and type of tissue involved, the TI parameter will be one of three types: 4-36 • Soft Tissue Thermal Index (TIS). Used when imaging soft tissue only, it provides an estimate of potential temperature increase in soft tissue. • Bone Thermal Index (TIB). Used when bone is near the focus of the image as in the third trimester OB examination, it provides an estimate of potential temperature increase in the bone or adjacent soft tissue. • Cranial Bone Thermal Index (TIC). Used when bone is near the skin surface as in transcranial examination, it provides an estimate of potential temperature increase in the bone or adjacent soft tissue. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 Safety Precautions Acoustic Output Display Specifications (continued) Mechanical Index MI recognizes the importance of non-thermal processes, cavitation in particular, and the Index is an attempt to indicate the probability that they might occur within the tissue. Changing the Thermal Index Type You can select the displayed TI type on Utility -> Imaging -> B-Mode. This preset is application dependent so each application could specify a different TI type. Display precision is ±0.1 and accuracy is ±50%. Accuracy of the power output displayed value on the Touch Panel is ±10%. Controls Affecting Acoustic Output The potential for producing mechanical bioeffects (MI) or thermal bioeffects (TI) can be influenced by certain controls. Direct. The Acoustic Output control has the most significant effect on Acoustic Output. Indirect. Indirect effects may occur when adjusting controls. Controls that can influence MI and TI are detailed under the Bioeffects portion of each control in the Optimizing the Image chapter. Always observe the Acoustic Output display for possible effects. LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 4-37 Safety Best practices while scanning HINTS NOTE: WARNING Acoustic Output Hazard Raise the Acoustic Output only after attempting image optimization with controls that have no effect on Acoustic Output, such as Gain and TGC. Refer to the sections in Chapter 5 for a complete discussion of each control. Be sure to have read and understood control explanations for each mode used before attempting to adjust the Acoustic Output control or any control that can effect Acoustic Output. Use the minimum necessary acoustic output to get the best diagnostic image or measurement during an examination. Begin the exam with the probe that provides an optimum focal depth and penetration. Acoustic Output Default Levels In order to assure that an exam does not start at a high output level, the LOGIQ E9 initiates scanning at a reduced default output level. This reduced level is preset programmable and depends upon the exam category and probe selected. It takes effect when the system is powered on or New Patient is selected. To modify acoustic output, adjust the Power Output level on the Touch Panel. 4-38 LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 Safety Precautions Warning Label Locations Figure 4-2. Label Location LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 4-39 Safety Warning Label Locations (continued) Table 4-9: Label Location Explanations 1. Possible shock hazard. Do not remove covers or panels. No user serviceable parts are inside. Refer servicing to qualified service personnel. 2. Signal ground point label CAUTION: This is only for “FUNCTIONAL GROUNDING”, NOT “PROTECTIVE EARTH”. 3. Prescription Device (For U.S.A. Only) 4. The equipment weighs approximately 135 kg (298 lbs). To avoid possible injury and equipment damage when transporting from one area of use to another: • Be sure the pathway is clear. • Limit movement to a slow careful walk. • Use two or more persons to move the equipment on inclines or long distance. 5. CISPR Emissions Label 6. WEEE symbol 7. BF Applied Part 8. The CE Mark of Conformity indicates this equipment conforms with the Council Directive 93/42/EEC. 9. ETL Label: NRTL Listing and Certification Mark is used to designate conformance to nationally recognized product safety standards. The Mark bears the name and/or logo of the testing laboratory, product category, safety standard to which conformity is assessed, and a control number. 4-40 10. Mercury Warning Label 11. “ATTENTION” - Consult accompanying documents” is intended to alert the user to refer to the operator manual or other instructions when complete information cannot be provided on the label. 12. Identification and Rating Plate–USA/Asia 120V console 13. Identification and Rating Plate–Europe/Asia/ USA 220V console 14. Identification and Rating Plate–China 15. Identification and Rating Plate– Korea 16. This machine should be used in compliance with law. Some jurisdictions restrict certain uses, such as gender determination. (shown for country specific label) 17. RoHS Label–China systems only (shown for country specific label) 18. GOST Mark - 220V system only–Russia (shown for country specific label) NOTE: [Not shown on the illustration] Grounding reliability can only be achieved when this equipment is connected to a receptacle marked “Hospital Only” or “Hospital Grade”. (For U.S.A., Canada, Japan) LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 Safety Precautions Warning Label Locations (continued) Figure 4-3. Rating Plate–USA/Asia 120V console Figure 4-4. Caution Label on the LCD Monitor LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 4-41 Safety 4-42 LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 Index A accessories ordering , 3-41 requesting a catalog , 3-41 accessory connector panel illustration , 1-10 accuracy clinical measurement , 2-34 acoustic output default levels , 4-38 active images , 1-37 air filter locating , 3-53 ALARA (as low as reasonably achievable), bioeffects , 4-3 area measurements ellipse , 2-19 spline , 2-22 trace , 2-20, , 2-21, , 2-22 B back view, console , 1-7 backing up data EZBackup/Move, see EZBackup/Move, using biological hazards , 4-11 B-Mode measurements, general , 2-17 B-Mode measurements, mode circumference and area (ellipse) , 2-19 circumference and area (spline trace) , 2-22 circumference and area (trace) , 2-20 distance , 2-18 Body Patterns , 2-13 brake location , 1-21 brightness, video , 1-15 C Care and maintenance cleaning the system air filter , 3-53 operator controls , 3-49 system cabinet , 3-48 inspecting the system , 3-47 maintenance schedule , 3-48 Caution icon, defined , 4-2 CINE gauge, display location , 1-14 LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 CINE mode activating , 2-12 circuit breaker description , 1-26 circumference measurements ellipse , 2-19 spline , 2-22 trace , 2-20, , 2-21, , 2-22 cleaning probes , 3-5 Clinical measurement accuracy , 2-34 Connectivity configuring , 3-34 overview of screens , 3-34 presets , 3-34 console back view , 1-7 front view , 1-7 left side view , 1-6 moving , 1-18 right side view , 1-6 contacts clinical questions , 3-40 Internet , 3-40 service questions , 3-40 contraindications , 1-3 Control Panel description , 1-11 controls operator , 1-11 probe keys , 1-29 Touch Panel , 1-12 D Danger icon, defined , 4-2 device labels , 4-15 devices acceptable , 4-35 unapproved , 4-35 disinfecting probes , 3-7 disinfecting solutions, probes , 3-7 distance measurement general , 2-18 Doppler measurements, mode TAMAX and TAMEAN , 2-25 time interval , 2-26 velocity , 2-24 Index-1 Doppler Mode, general measurements , 2-24 E electrical configurations , 1-4 electrical hazard , 4-10 electromagnetic compatiblity (EMC) , 4-23 ellipse measurement, general , 2-19 EMC (electromagnetic compatiblity) , 4-23 equipment safety , 4-9 Exam Data Transfer, description , 1-37 exam study, display location , 1-14 explosion hazard , 4-9 EZBackup/Move, using , 3-24 F Fast Key , 2-14 Federal law (USA), requirements , 1-2 freezing an image , 2-12 front view, console , 1-7 G Gels, coupling , 3-13 H hazards , 3-12 hazards, safety symbols , 4-3 hazards, types biological , 4-11 electrical , 4-7, , 4-10 explosion , 4-9 mechanical , 4-7 I Indications for Use , 1-3 information, requesting , 3-40 L left side view, console , 1-6 LOGIQ system contraindications , 1-3 Indications for Use , 1-3 M measurement controls, location , 2-16 Measurement Summary window, display location , 1-14 M-Mode measurements, mode time interval , 2-28 time interval and velocity , 2-28 tissue depth , 2-27 M-Mode, general measurements , 2-27 Index-2 moving the system , 1-16 precautions , 1-18 releasing the brake , 1-21 N new patient scanning , 1-34 O Operator controls , 3-49 P patient safety , 4-5 Patient Screen active images , 1-37 Exam Data Transfer , 1-37 peripherals connector panel illustration , 1-10 location , 1-7 Power Cord , 1-16 On/Off Standby , 1-22 switch, location , 1-22 power circuit breaker , 1-26 shut down , 1-24 prescription device, caution , 1-2 presets, changing Connectivity , 3-34 Probe handling and infection control , 3-3 probe identifier, locating , 1-14 Probes connecting , 1-28 probes activating , 1-29 cable handling , 1-29 cleaning , 3-5 coupling gels coupling gels, probes , 3-13 disconnecting , 1-30 disinfecting , 3-7 immersion levels , 3-6 prudent use , 4-2 R Results window display location , 1-14 moving to new location , 1-14 right side view, console , 1-6 LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 S safety electromagnetic compatiblity (EMC) , 4-23 equipment , 4-9 hazards , 4-3, , 4-9, , 4-10, , 4-11, , 4-38 biological , 3-12 smoke and fire , 4-11 labels , 4-15 patient , 4-5 acoustic output hazard hazard, types acoustic output , 4-8 electrical hazards , 4-7 mechanical hazards , 4-7 patient identification , 4-5 patient training, ALARA , 4-8 personnel , 4-9 precaution icons, defined , 4-2 precaution levels, defined , 4-2 probes handling precautions , 3-3 service, requesting , 3-40 system electrical configurations , 1-4 power down , 1-24 System cabinet , 3-48 system messages, display location , 1-14 T TAMAX and TAMEAN, Doppler mode measurement auto trace , 2-25 manual trace , 2-25 Time interval Doppler mode measurement , 2-26 M-Mode measurement , 2-28 time interval and velocity, M-Mode measurements , 2-28 Tissue depth, M-Mode measurement , 2-27 Trace measurement, general , 2-20, , 2-21, , 2-22 Trackball functionality status, display location , 1-14 U Utility screens connectivity , 3-34 V Velocity, Doppler measurement , 2-24 W Warning icon, defined , 4-2 Worksheet changing data , 2-31 viewing , 2-29 LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 Index-3 Index-4 LOGIQ E9 – User Guide Direction 5389561-100 English Rev. 1 GE Healthcare ">
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Key Features
- Supports a variety of clinical applications
- Provides high-quality ultrasound images
- Includes features for image optimization and measurement
- Can be used for both portable and stationary exams
- Easy to use and navigate
- Compliant with industry standards
- Offers advanced features for 3D and 4D imaging
Frequently Answers and Questions
What are the clinical applications of the LOGIQ E9 ultrasound system?
The LOGIQ E9 is intended for use by a qualified physician for ultrasound evaluation. Specific clinical applications and exam types include: fetal/obstetrics, abdominal, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, peripheral vascular, musculo-skeletal, urology, transrectal, transvaginal, transesophageal and intraoperative.
How do I connect a probe to the LOGIQ E9?
Probes can be connected at any time, regardless of whether the console is powered on or off. To connect a probe, place the probe's carrying case on a stable surface and open the case. Carefully remove the probe and unwrap the probe cord. DO NOT allow the probe head to hang free. Impact to the probe head could result in irreparable damage. Turn the connector locking handle to the left. Align the connector with the probe port and carefully push into place. Turn the connector locking handle to the right to secure the probe connector. Carefully position the probe cord so it is free to move, yet not dragging on the floor.
What is Sleep Mode and how do I use it?
Use Sleep Mode when you do a portable exam in order to reduce the time to start up the system. When you use Sleep Mode, it takes ~90 seconds to start up the system versus 2-3 minutes. To activate Sleep Mode, press the On/Off button and select Sleep. When the On/Off button turns from Green to Orange, unplug the power cord from the wall. To bring the system out of Sleep Mode, press the On/Off button.