OEC 9800 Plus Operator Manual Rev A March 2002

Contents

Text Manual Revision History Rev

Dash Date

Change Description

2 A

-01 -01

Engineering Release Initial Release

March 2002 March 2002

© 2002 GE OEC Medical Systems, Inc. 384 Wright Brothers Dr. Salt Lake City, Utah 84116 CAUTION! US Federal law restricts this device to sale by, or on the order of, a physician.

The text of this manual was originally written, approved and published by the manufacturer in English (P/N 884628-01). 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. This product is covered under one or more of the following U.S. and foreign patents: 5,596,228; 08/209,001; 5,426,683; 5,506,882; 5,583,909; 4,797,907; 07/638,176. Other U.S. and foreign patents pending. Made in the U.S.A. This manual contains descriptions, instructions, and procedures which apply only to OEC 9800 C-Arms and OEC Workstations. Page ii

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 ... 1-3 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 ... 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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Contents

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

Start-up and Storage ... 2-1 Overview ... 2-1 Power On ... 2-2 Draping ... 2-8 Draping the X-ray Tube Cooling Kit Option ... 2-9 Standby or X-rays Off ... 2-10 Power Off ... 2-11 C-arm Storage ... 2-12 Temporary Storage (less than 60 days) ... 2-12 Long Term Storage or Shipment (60 days or more) ... 2-13

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Contents

Operating Controls... 3-1 Overview ... 3-1 Control Panel Housing ... 3-2 Control Panel ... 3-3 Image Orientation ... 3-4 Remote Workstation Operation ... 3-5 Image Intensifier Field Size ... 3-7 Collimator Control ... 3-8 Contrast/Brightness/Metal Rejection ... 3-10 Generator Control ... 3-12 Fast Stop Switches ... 3-17 X-ray On Switch ... 3-19 Footswitch and Handswitch ... 3-20 Switching Mode Pairs ... 3-24

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Contents

Mechanical Positioning ... 4-1 Overview ... 4-1 C-arm Identification ... 4-2 Component Identification ... 4-3 C-arms with 23 or 31 cm (9 or 12-inch) Image Intensifiers ... 4-3 Super C-arms ... 4-5 Positioning ... 4-6 C-arm Orbital Rotation ... 4-7 C-arm Orbital Rotation Brake ... 4-8 Super C-arm Orbital Rotation ... 4-9 Super C-arm Orbital Rotation Brake ... 4-10 Flip-Flop Rotation ... 4-11 Flip-Flop Rotation Brake ... 4-12 L-arm Rotation ... 4-13 L-arm Brake ... 4-14 Super C-arm Radial Rotation ... 4-15 Super C-arm Radial Rotation Brake ... 4-16 Vertical Column Operation ... 4-17 Vertical Column Switches ... 4-18 Horizontal Cross-arm ... 4-19 Horizontal Cross-arm Brake ... 4-20 Wig-Wag ... 4-21 Wig-Wag Brake ... 4-22 9800 C-Arm Wheel Brakes ... 4-23 9800 C-Arm Steering Handle ... 4-24 Moving the C-arm ... 4-25

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Contents

Radiographic Film ... 5-1 Overview ... 5-1 Setup and Make a Film Exposure ... 5-2 Prearm for Film Exposure ... 5-6

Maintenance... 6-1 Overview ... 6-1 Performance Checks ... 6-3 Mechanical Performance Check ... 6-3 Electrical Performance Check ... 6-5 Fast Stop Performance Check ... 6-6 Fluoro Mode Performance Check ... 6-7 Film Mode Performance Check ... 6-9 Cleaning ... 6-10 Periodic Maintenance ... 6-11

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Contents

Display Messages ... 7-1 Overview ... 7-1 Error Recovery Steps ... 7-2 Messages ... 7-3

Labels and Symbols ... 8-1 Overview ... 8-1 Labels ... 8-2 Symbols ... 8-4

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Contents

Technical Reference ... 9-1 Overview ... 9-1 Camera Output Video Signal ... 9-2 Classification Type ... 9-2 Electromagnetic Compatibility Statement ... 9-3 Environmental Requirements ... 9-4 Power Requirements ... 9-5 X-ray Source Assembly ... 9-6 Collimation ... 9-8 Tube Rating Charts ... 9-9 Radiographic Ratings (50 Hertz) ... 9-10 Radiographic Ratings (60 Hertz) ... 9-11 Heating and Cooling Charts-Tube Housing ... 9-12 Heating and Cooling Charts-Anode ... 9-14 Generator Specifications ...9-15 Generator Operating Parameters ... 9-16 Measurement Basis for Technique Factors ... 9-17 Radiographic mA As a Function of kV and mAs ... 9-18 Focal Spot (0.3 mm) ...9-20 Focal Spot (0.6 mm) ...9-21 Dimensions ... 9-22 C-arm (9-inch II) ... 9-22 C-arm (12-inch II) ... 9-23 Super C-arm ... 9-24 Film Cassette Dimensions ... 9-25 Material Safety Data Sheets ... 9-25 Optional Equipment ... 9-26 Consumables ... 9-26

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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.

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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 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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Introduction and Safety

Safety Hazard Alerts There are three hazard classifications, which are denoted and prioritized by the alert words: 1. Danger 2. Warning 3. Caution This list describes the use of each classification: Alert DANGER

Circumstances for Use Danger indicates an imminently hazardous situation which, if not avoided, will result in death or serious injury.

WARNING

Warning indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.

CAUTION

Caution indicates a potentially hazardous situation which, if not avoided, may result in moderate to minor injury, equipment damage or loss of data.

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Introduction and Safety

Explosion If your system complies with the requirements of IEC 60601-1 regarding Anesthetic Proof (AP) equipment, an AP label will be located on the equipment. An AP label means that under normal conditions certain components may be operated safely in close proximity to flammable gases. However, if an abnormal condition occurs, such as the room fills with flammable gas, steps must be taken to prevent the gas from coming in contact with non AP rated components within the equipment. Follow these guidelines: 1. Do not turn the system off or unplug it from the AC receptacle. 2. Do not operate any other electrically powered equipment. 3. Evacuate all personnel from the area and ventilate with fresh air. Avoid operating any automated (electrically operated) doors or windows. 4. Contact your local fire department as soon as possible.

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