MiniView 6800 Operators Manual Rev F May 2006

Text Revision History Rev 1

Dash -01

Date December 2000

Change Description Engineering Release

2

-01

January 2001

Incorporated Engineering Changes

3

-01

March 2001

Incorporated Final Engineering Changes

A

-01

March 2001

Manufacturing Release

B

-01

April 2001

Incorporated screen dose readout changes in Chapter 6

C

-01

August 2001

Added Caution on page 3-23; Corrected dimensions in Chap. 12; Added Laser Aimer Labels in Chap. 13

D

-02

December 2001

Revised callout/text matching in Chap. 3; changed (where appropriate) labeling from “Rad” to “rad” in Chap. 9, and “Dose” to “Exposure” in Chap. 13

E

-02

January 2002

Corrected page 2-11; Corrected dimensions in Chap. 13

F

-03

May 2006

Added: new warnings, Chap. 2; measurement software operation, Chap. 8; A-Arm adjustment, Chap. 10; numbered chapter titles; general editing

© 2001, 2002, 2006 GE OEC Medical Systems, Inc. 384 Wright Brothers Dr. Salt Lake City, Utah 84116 Page ii

CAUTION 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. All trademarks and registered trademarks are trademarks or registed trademarks of their respective holders. MiniView is a registered trademark of GE OEC Medical Systems, Inc. in the USA and other countries. The text of this manual was originally written, approved, and published by the manufacturer in English (part number 00-881794-03). Companies, names, and data used in examples herein are fictitious unless otherwise noted. U.S. and foreign patents pending. Made in the U.S.A. This manual contains descriptions, instructions, and procedures which apply only to the MiniView 6800 Imaging System.

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Contents

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Contents

Table of Contents Introduction and Safety ... 1-1 Overview ... 1-1 Owner Responsibilities ... 1-2 System Compatibility ... 1-2 Operator Qualifications ... 1-2 Continued Compliance ... 1-2 Unauthorized Modifications ... 1-3 GE OEC Medical Systems, Inc. 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 ... 1-12 Improperly Attached Equipment ... 1-13 Electric Shock ... 1-14 Electrical Fire ... 1-15 Ground Fault ... 1-16 Radiation Exposure ... 1-17 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 Page v

Contents

Setup and Positioning ... 2-1 Overview ... 2-1 MiniView System Components ... 2-2 Moving the MiniView System ... 2-4 Brake Pedal Positions ... 2-7 Instability Warning ... 2-8 Toe Entrapment Warning ... 2-9 Do Not Push Warning ... 2-10 Connecting the MiniView System ... 2-11 Turning the System On ... 2-12 Turning the System Off ... 2-13 Positioning C-Arm Movements ... 2-14 Change Elevation ... 2-15 Pivot Movements ... 2-16 Rotate C-Arm ... 2-16 Arc Orbital Movement ... 2-17

MiniView System Controls ... 3-1 Overview ... 3-1 Touchscreen Controls ... 3-2 Workstation Keyboard ... 3-3 Navigation and Text-Entry Keys ... 3-4 Image Processing Keys ... 3-6 Function Keys ... 3-15 Diacritic Keys ... 3-17 Footswitch and Handswitch ... 3-18 C-Arm Control Panel ... 3-20 Laser Aimer ... 3-23

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Contents

Patient Information ... 4-1 Overview ... 4-1 Patient Information Screen`... 4-2 Entering Patient Information ... 4-4 Selecting a Patient from the Scheduled Exams ... 4-6 Selecting a Patient from Saved Exams ... 4-10 Editing Patient Information ... 4-13

Imaging... 5-1 Overview ... 5-1 Status Bar ... 5-1 To Image a Patient ... 5-2 Fluoro Imaging ... 5-5

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Contents

Image Review, Hardcopy and Archive ... 6-1 Overview ... 6-1 Accessing Image Directory ... 6-2 Reviewing Images ... 6-4 Reviewing Dose Information ... 6-6 Hardcopying Images ... 6-8 Hardcopy Devices ... 6-8 Storage Devices... 6-8 Selecting a Hardcopy or Storage Device ... 6-9 Selecting a Layout... 6-10 Making a Hardcopy ... 6-11 To Hardcopy a Static Image ... 6-12 To Hardcopy the Dose Summary ... 6-13 To Hardcopy Patient Information ... 6-14 To Clear the Copy Queue ... 6-15 Archiving Images ... 6-16 Archiving Static Images ... 6-17 Clearing the Storage Device Queue ... 6-19 Retrieving a Saved Exam ... 6-20 Retrieving an Archived Exam ... 6-22

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Contents

Annotating Images ... 7-1 Overview ... 7-1 Using Markers ... 7-2 Using Comments ... 7-4 Using Crop ... 7-6

Special Applications ... 8-1 Overview ... 8-1 Calibration ... 8-4 To Perform Calibration ... 8-5 Distance ... 8-6 To Perform Distance Measurements ... 8-7 Stenosis ... 8-8 To Delete Measurements ... 8-8

Customizing Operation ... 9-1 Overview ... 9-1 WorkStation Options ... 9-2 Miscellaneous Options ... 9-4 Time and Date ... 9-7 Patient Information ... 9-9

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Contents

Maintenance ... 10-1 Overview ... 10-1 Performance Checks ... 10-3 Check Mechanical Performance ... 10-3 Check Electrical Performance ... 10-3 A-Arm Tension Adjustment ... 10-4 Cleaning ... 10-6 Periodic Maintenance Schedule ... 10-7 Semi-Annual Maintenance ... 10-7 Long-Term Storage or Shipment ... 10-8

Messages ... 11-1 Overview ... 11-1 Error Recovery Steps ... 11-2 Messages... 11-3

Labels and Symbols... 12-1 Overview ... 12-1 Labels ... 12-2 Symbols ... 12-7

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Contents

Technical Reference... 13-1 Overview ... 13-1 System Classification ... 13-2 Optional Equipment ... 13-2 Replacement Items ... 13-3 Video Signal ... 13-3 Environmental Requirements ... 13-4 External Connections ... 13-5 Power Requirements ... 13-6 System Input power ... 13-6 Connector Output Voltages ... 13-6 Material Safety Data Sheets ... 13-7 Measurement Basis, Technique Factors ... 13-7 X-ray Source Assembly ... 13-8 Fluoroscopic Accuracy ... 13-8 Image Intensifier ... 13-9 Laser Aimer ... 13-9 Monoblock X-ray Generator ... 13-10 Heating and Cooling Characteristics ... 13-11 Fluoroscopic Technique–Anatomy Factors ... 13-12 Entrance Exposure Rates (EER) ... 13-14 Source-to-Skin Distance (SSD) ... 13-15 System Size ... 13-16 Base Dimensions ... 13-16 C-Arm Extension ... 13-16 Transport Position ... 13-16 Stability ... 13-16 Weight ... 13-16 Imaging Area ... 13-18 Orbital Travel ... 13-19 Wig-Wag and Rotation ... 13-20

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Contents

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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.

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.

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Introduction and Safety

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 of Quality and Regulatory Affairs 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 OEC Medical Systems, GmbH Wilhelm-Maisel Strasse 14 90530 Wendelstein, Germany Phone: 011-49-9129-282830 Fax: 011-49-9129-270972 The following pages describe hazardous and potentially hazardous conditions, and how to adequately protect yourself and others from possible injury.

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