OEC Workstation Operator Manual Rev E-05 Nov 2002

Text Manual Revision History Rev Dash Date A -01 April 1999 B -02 September 1999 C -03 April 2000 D -04 April 2001 E -05 November 2002

Change Description Release version Software updates; editorial New configurations; upgrades Content changes Content changes

© 1998-2002 GE-OEC Medical Systems, Inc.

CAUTION! US Federal law restricts this device to sale by, or on the order of, a physician.

This manual may not be reproduced, in whole or in part, without the written permission of GE OEC Medical Systems, Inc. The material in this manual is provided for informational purposes only and is subject to change without notice. OEC is a trademark of GE OEC Medical Systems, Inc. in the USA and other countries. Other product and company names mentioned herein are the property of their respective owners. The text of this manual was originally written, approved, and published by the manufacturer in English. Companies, names, and data used in examples herein are fictitious unless otherwise noted. US and foreign patents pending. Made in the USA. This manual contains descriptions, instructions, and procedures which apply only this product.

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Contents

Contents Introduction and Safety ... 1-1 Overview ... 1-1 Owner Responsibilities ... 1-2 System Compatibility ... 1-2 Operator Qualifications ... 1-2 Continued Compliance ... 1-3 Unauthorized Modifications ... 1-3 GE OEC Responsibilities ... 1-4 X-ray Equipment Certification ... 1-4 After-sale Operating and Safety Practices ... 1-4 Communication Center Telephone Numbers ... 1-5 Ordering Consumable Items ... 1-6 Phone ... 1-6 Fax ... 1-6 On-line ... 1-7 Safety Hazards ... 1-8 Safety Hazard Alerts ... 1-9 Explosion ... 1-10 Implosion ... 1-11 Equipment Stability and Positioning ... 1-12 Motorized Mechanical Movement ... 1-13 Improperly Attached Equipment ... 1-13 Electrical Shock ... 1-14 Electrical Fire ... 1-15 Ground Fault ... 1-16

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Radiation Exposure ... 1-17 General Protection ... 1-17 Source-to-Skin Distance ... 1-18 Ingress of Fluids ... 1-19 Cooling Efficiency ... 1-19 Burns ... 1-19 Electromagnetic Compatibility Statement ... 1-20 Equipment Malfunction ... 1-21 External Devices ... 1-22 Patient Environment ... 1-23 Within the United States ... 1-23 Outside the United States ... 1-24

Setup and Positioning ... 2-1 Overview ... 2-1 Workstation Components ... 2-2 Brake Pedal ... 2-5 Moving the Workstation ... 2-6 Turning the Workstation On ... 2-8 Turning the Workstation Off ... 2-9 Mobile Systems ... 2-9 Fixed Room Systems ... 2-10

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Contents

Using the Workstation Controls ... 3-1 Overview ... 3-1 Touchscreen Controls ... 3-2 OEC Workstation Keyboard ... 3-4 Navigation and Text-Entry Keys ... 3-6 Diacritic Keys ... 3-8 Image Processing Keys ... 3-9 Function Keys ... 3-22 Remote Control ... 3-24

Patient Information ... 4-1 Overview ... 4-1 Patient Information Screen ... 4-2 Enter Patient Information ... 4-4 Scheduled Exams Feature ... 4-6 Set up the Scheduled Exams feature ... 4-7 Select a patient from Scheduled Exams ... 4-8 Select a Patient from Saved Exams ... 4-10 Edit Patient Information ... 4-13 To edit information ... 4-14 To edit the COMMENT line ... 4-15

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Fluoro Imaging ... 5-1 Overview ... 5-1 X-Ray Switch Setup ... 5-2 MODE Screen ... 5-2 Status Bar ... 5-4 Fluoro Imaging ... 5-5 To produce a Fluoro image ... 5-5 High Level Fluoro Imaging ... 5-6 Standard HLF ... 5-7 To produce a standard HLF image ... 5-7 Digital Spot Imaging ... 5-8 To produce a Digital Spot image ... 5-8 Enable Pulsed X-ray ... 5-9 To change pulse rate ... 5-11 Cardiac Fluoro Pulse Rates ... 5-13 To change ( + ) pulse rate ... 5-14 Saving Images ... 5-15

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Contents

Vascular Imaging ... 6-1 Overview ... 6-1 X-Ray Switch Setup ... 6-2 Mode Screen... 6-2 Vascular and Neuro-Vascular Systems ... 6-4 Cardiac Systems ... 6-5 Mode Pairs ... 6-6 Switching Mode Pairs ... 6-7 To set up imaging modes available during the exam ... 6-8 Vascular and Neuro-Vascular Systems ... 6-10 Cardiac Systems ... 6-12 Cardiac Button/Icon ... 6-12 Subtraction Imaging ... 6-15 Sequence of Events During Subtraction ... 6-16 Subtraction Procedure ... 6-18 Adjusting the Mask ... 6-20 Registration ... 6-20 To register the roadmap mask... 6-20 Landmarking ... 6-21 Roadmap Imaging ... 6-22 Sequence of Events During Roadmapping ... 6-23 Roadmap 1st Phase ... 6-24 Roadmap 2nd Phase ... 6-25 Roadmap Procedure ... 6-26 Selecting and Clearing a Roadmap Mask ... 6-28 Using a Saved Mask ... 6-29 Clearing the Current Mask ... 6-30 Produce a Roadmap Mask from a Subtraction Cine Run ... 6-31 Digital Cine Pulse ... 6-33 Create a Digital Cine Pulse image ... 6-34 Cardiac Systems ... 6-34 To change rate ... 6-35 Vascular and Neuro-Vascular Systems ... 6-36

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Image Review, Hardcopy and Archive ... 7-1 Overview ... 7-1 Image Directory ... 7-2 Review Dose Information ... 7-4 Retrieve a Saved Exam ... 7-6 Image Review ... 7-9 Hardcopy/Print Images ... 7-10 Select a Device ... 7-11 Select a Layout ... 7-12 Print ... 7-13 Hardcopy/Print the Dose Summary ... 7-15 Hardcopy/Print Patient Summary ... 7-15 Clear the Copy Queue ... 7-16 Copy (Archive) Images ... 7-17 Overview ... 7-18 Select a Storage Device ... 7-19 Select a Copy Format ... 7-20 To choose a Copy Format ... 7-21 Copy to Archive Device ... 7-22 Static Images ... 7-22 Cine Runs ... 7-24 Clear the Storage Device Queue ... 7-25 Copy From an Archive Device ... 7-26

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Contents

Dynamic Recording ... 8-1 Overview ... 8-1 Cine Options ... 8-2 To activate the cine disk ... 8-4 Acquire ON/OFF ... 8-6 To change continuous acquisition rate ... 8-7 Cine Run Review ... 8-9 Review a Cine Run ... 8-10 Select Cine Runs from the Cine Screen ... 8-13 Set Mask ... 8-14 Set Cues ... 8-15 Viewing Options ... 8-17 View in Subtracted and Unsubtracted Form ... 8-18 Perform a Post-processing Subtraction ... 8-19 Apply Peak Opacification during playback ... 8-20 Adjust Mask ... 8-21 Roadmap Mask ... 8-22

Annotating Images ... 9-1 Overview ... 9-1 Markers ... 9-2 Place markers on an image ... 9-2 Comments ... 9-4 Add comments to an image ... 9-4 Crop ... 9-6 Crop an image ... 9-6

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Special Applications ... 10-1 Overview ... 10-1 Calibration ... 10-4 To Perform Calibration ... 10-5 Distance ... 10-6 To perform distance measurements ... 10-7 Stenosis ... 10-8 To perform stenosis ... 10-9 To delete measurements ... 10-10

Customizing ... 11-1 Overview ... 11-1 Customize Screen ... 11-2 To access Customize features ... 11-2 Workstation Options Screen ... 11-3 Miscellaneous Options Screen ... 11-4 Adjust alarm tone ... 11-6 Set defaults ... 11-7 Time and Date ... 11-8 Set time and date ... 11-8 Patient Information Screen ... 11-10 Accession Numbers ... 11-12 Customize Video (Uroview only) ... 11-13

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Contents

Maintenance ... 12-1 Overview ... 12-1 Performance Checks ... 12-3 Check Mechanical Performance ... 12-3 Check Electrical Performance ... 12-3 Cleaning ... 12-4 IR Remote Control ... 12-5 To replace the batteries ... 12-5 Long-Term Storage or Shipment ... 12-6 Periodic Maintenance Schedule ... 12-7 Semi-Annual Maintenance ... 12-7

Troubleshooting ... 13-1 Overview ... 13-1 Error Recovery Steps ... 13-2 Messages ... 13-3

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Technical Reference ... 14-1 Overview ... 14-1 Workstation Classification ... 14-2 Dimensions ... 14-3 Dose Area Product ... 14-4 Environmental Requirements ... 14-6 External Connections ... 14-7 Labels and Symbols ... 14-9 Overview ... 14-9 Labels ... 14-10 Symbols ... 14-12 Material Safety Data Sheets ... 14-15 Optional Equipment ... 14-16 Power Requirements ... 14-17 System Input power ... 14-17 Connector Output Voltages ... 14-19 Replacement Items ... 14-20 Video Signal ... 14-20

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Chapter 1

Introduction and Safety Overview This manual describes operation for the specified product only. It is intended for qualified medical personnel who have been trained in the use of medical imaging equipment. It is not designed to replace or substitute for certified training in the radiological or medical field. Functional capabilities and operation of the equipment are described here which can be used in a variety of diagnostic, therapeutic and surgical applications.

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Introduction and Safety

Owner Responsibilities The owner has the responsibility to ensure system compatibility, operator qualifications and the continued compliance of equipment and operating specifications. Systems should only be used in designated use areas with approved AC receptacles. Unauthorized changes or modifications to any part of the system could have hazardous consequences. Changes or modifications must not be made unless specifically authorized by GE OEC Medical Systems, Inc.

System Compatibility Damage may result to the system if incompatible components are connected. Read your operator manual thoroughly prior to connecting components that you are not certain are compatible.

Operator Qualifications It is the responsibility of the owner to ensure that the system is operated only by properly trained, qualified personnel who have obtained credentials from the appropriate authorities.

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Introduction and Safety

Continued Compliance The owner is responsible for verifying continued compliance with all applicable regulations and standards. Consult local, state, federal and/or international agencies regarding specific requirements and regulations applicable to the use of this type of medical electronic equipment.

Unauthorized Modifications When properly assembled this equipment meets US Federal regulations and International standards. Unauthorized modifications to the equipment may impact adherence to these standards and make the equipment unsafe to operate. Never make any modifications or adjustments to the equipment unless directed by a qualified GE OEC representative.

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Introduction and Safety

GE OEC Responsibilities GE OEC Medical Systems, Inc. certifies each system and X-ray source assembly. After-sale operating practices and safety are the responsibility of the owner/operator.

X-ray Equipment Certification GE OEC Medical Systems, Inc. certifies that when assembled according to manufacturer's instructions, the X-ray equipment complies with the US Federal Performance standard 21 CFR Subchapter J and applicable international standards.

After-sale Operating and Safety Practices GE OEC Medical Systems, Inc. assumes no responsibility or liability for after-sale operating and safety practices; nor can it be responsible for personal injury or damage resulting from misuse of its systems.

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Introduction and Safety

Communication Center Telephone Numbers If the system does not operate properly or fails to respond to the controls as described in your operator’s manual, call GE OEC Medical Systems, Inc. to request service. The communication center's telephone numbers are listed below: US: 800 874-7378 China: 800 810-8188 All others: Contact local GE Medical Systems, Inc. office. You may also call these numbers to order circuit diagrams, component part lists, calibration instructions or other information which will assist qualified service engineers to repair the system.

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Introduction and Safety

Ordering Consumable Items You may order GE OEC consumables such as steri-drapes and printer paper, by phone, fax, or on-line.

Phone 1. Call the number that corresponds to your geographical location. US: 800 558-5102 Canada: 800 668-0732 China: 800 810-8188 All other locations: Contact your local sales representative. 2. Establish an account with the customer service representative. 3. Place your order.

Fax If you have a catalog and a GE Fax Order form, complete the form and fax the form to the fax number listed on the form. If you do not have a catalog or forms, you can obtain them by dialing the number listed for your geographical location.

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Introduction and Safety

On-line You can order consumables on the GE Medical System, Inc. web site from any geographical location but prior to ordering you must register on-line to open an account. Registration is free. 1. Go to www.gemedicalsystems.com. 2. Register to open an account. Note: Record your user name and password for future account access. 3. Login using the user name and password that you established when you registered. 4. Browse through the on-line catalog and locate the OEC Supplies that you want to purchase. Note: If you have difficulties, dial the telephone number listed previously for your geographical location or contact your local sales representative.

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Introduction and Safety

Safety Hazards Potential hazards exist in the use of medical electronic devices and X-ray systems. Operators using the equipment should understand the safety issues, emergency procedures, and the operating instructions provided. Questions and comments regarding safety should be addressed to the GE OEC Medical Systems, Inc. service organization nearest them. Unresolved problems should be referred to: Vice President, Quality GE OEC Medical Systems, Inc. P.O. Box 25296 Salt Lake City, Utah 84125-0296 (801) 328-9300 GE OEC Medical Systems has designated the following entity to act as the European Union (EU) representative in matters dealing with the Medical Devices Directive under Annexes I and II: GE Medical Systems, SA 283, rue de la Minière B.P. 34 F 78533 Buc Cedex France +33 (0) 1 30 70 40 40 The following pages describe hazardous and potentially hazardous conditions, and how to adequately protect yourself and others from possible injury.

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