GE Brivo OEC 715 User manual

5358650-1EN
Rev.16
©2020
General Electric Company
All rights reserved
For USA, OEC Brivo Prime/OEC Brivo Essential/OEC Brivo Plus are respectively described as Brivo OEC 715/Brivo OEC
785/Brivo OEC 865 in the manual.
GE Healthcare
Mobile C-Arm X-Ray Product
Operator Manual
Brivo OEC 715/Brivo OEC 785/Brivo OEC 865

Page ii
Revision History
Revision
Date (Month & Year)
Description of Change
1
June 2012
Initial Release
2
Oct. 2012
Update Information
3
Nov. 2012
Update Information
4
Mar. 2013
Update Information
5
July 2013
Update Information
6
Sep. 2013
Update Information
7
Nov. 2015
Update Information
8
Feb. 2016
Update Information
9
Aug. 2016
Update Information
10
May. 2017
Update Information
11
Aug. 2017
Update Information
12
Dec.2017
Update Information
13
Nov.2018
Update Information
14
Apr.2020
Update Information
15
Sep.2020
Update Information
16
Dec.2020
Update Information
U.S. federal law restricts this device to sale by or on the order of a physician,
veterinarian, or other designated licensed practitioner as appropriate for its clinical use.
IMPORTANT SAVE THESE INSTRUCTIONS. PLEASE READ THIS MANUAL BEFORE USING Brivo OEC 715/Brivo OEC
785/Brivo OEC 865 Mobile C-Arm X-Ray Product.
This manual may not be reproduced, in whole or in part, without the written permission of GE Healthcare.
Other product and company names mentioned herein are the property of their respective owners.
The contents of this document are accurate at the time of publication. However, changes in design and
additional features can, at any time, be incorporated in the hardware and software and may not be reflected in
this version of the document. Contact GE Healthcare Technical Support for clarification, if discrepancies arise.
The text of this manual was originally written, approved and published by the manufacturer in English.
GE HUALUN Medical Systems Co. Ltd., a General Electric company, going to market as GE Healthcare.
GE HUALUN Medical Systems Co. Ltd.
No. 1 Yongchang North Road
Beijing Economic & Technological Development Zone
Beijing, P.R. China 100176
Tel: [phone]
Fax: [phone]
CAUTION

Page iii
REGULATORY REQUIREMENTS
International Electrotechnical Commission (IEC), international standards organization, when
applicable.
This product conforms with the Medical Device Directive, Council Directive 93/42/EEC: June 14,
1993, as amended by 2007/47/EC following the provisions of Annex II, when it bears the
following CE Mark of Conformity.
European Representative:
GE Medical Systems S.C.S.
Quality Assurance Manager
283 rue de la Minière
78530 BUC France
Tel: [phone]

Contents
Page iv
Contents
Chapter1. Introduction and Safety ......................................................................1-1
1.1. Overview .................................................................................................................................................................... 1-2
1.2. Owner Responsibilities........................................................................................................................................ 1-2
1.2.1. System Compatibility................................................................................................................................ 1-2
1.2.2. Operator Qualifications ........................................................................................................................... 1-2
1.2.3. Continued Compliance ............................................................................................................................ 1-2
1.2.4. Unauthorized Modifications .................................................................................................................. 1-3
1.3. Manufacturer's Responsibilities...................................................................................................................... 1-4
1.3.1. X-Ray Equipment Certification............................................................................................................. 1-4
1.3.2. After-sale Operating and Safety Practices..................................................................................... 1-4
1.3.3. Essential Performance ............................................................................................................................. 1-4
1.4. Communication Center Telephone Numbers .......................................................................................... 1-4
1.5. Safety Hazards........................................................................................................................................................ 1-5
1.5.1. Safety Hazard Alerts ................................................................................................................................. 1-5
1.5.2. Explosion......................................................................................................................................................... 1-5
1.5.3. Equipment Stability and Positioning ................................................................................................. 1-6
1.5.4. Motorized Mechanical Movement...................................................................................................... 1-6
1.5.5. Improperly Attached Equipment......................................................................................................... 1-6
1.5.6. Electrical Fire................................................................................................................................................. 1-7
1.5.7. Ground Fault................................................................................................................................................. 1-7
1.5.8. Improper Access ......................................................................................................................................... 1-7
1.6. Radiation Exposure............................................................................................................................................... 1-8
1.6.1. General Protection..................................................................................................................................... 1-8
1.6.2. Source-to-Skin Distance ......................................................................................................................... 1-8
1.6.3. Dose to Patient ............................................................................................................................................ 1-9
1.7. Ingress of Fluids....................................................................................................................................................1-16
1.8. Cooling Efficiency ................................................................................................................................................1-16
1.9. Burns..........................................................................................................................................................................1-16
1.10. Electromagnetic Compatibility Statement ..............................................................................................1-17
1.11. Equipment Malfunction ....................................................................................................................................1-24
1.12. Mains Isolation......................................................................................................................................................1-24

Contents
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1.13. External Devices................................................................................................................................................... 1-24
1.14. Patient Environment ..........................................................................................................................................1-25
1.14.1. Within the United States....................................................................................................................... 1-25
1.14.2. Outside the United States ....................................................................................................................1-25
Chapter2. System Overview .................................................................................. 2-1
2.1. General Description...............................................................................................................................................2-2
2.2. C-Arm Components...............................................................................................................................................2-3
2.3. Workstation Components..................................................................................................................................2-5
Chapter3. Mechanical Positioning ....................................................................... 3-1
3.1. Overview.....................................................................................................................................................................3-2
3.2. Positioning .................................................................................................................................................................3-2
3.2.1. C-Arm Orbital Rotation .............................................................................................................................3-2
3.2.2. Lateral Rotation ...........................................................................................................................................3-3
3.2.3. Wig-Wag .........................................................................................................................................................3-4
3.2.4. Vertical Column Operation .....................................................................................................................3-5
3.2.5. Horizontal Cross-Arm................................................................................................................................3-6
3.2.6. C-Arm Brakes ................................................................................................................................................3-7
3.2.7. C-Arm Steering Handle.............................................................................................................................3-8
3.2.8. Workstation Monitor Adjustment ........................................................................................................3-8
3.2.9. Workstation Brakes....................................................................................................................................3-9
3.3. Moving the C-Arm and Workstation ..........................................................................................................3-10
3.3.1. Overview....................................................................................................................................................... 3-10
3.3.2. Moving the C-Arm....................................................................................................................................3-11
3.3.3. Moving the Workstation........................................................................................................................ 3-12
Chapter4. Start Up and Operating Control ........................................................ 4-1
4.1. Overview.....................................................................................................................................................................4-2
4.2. Start Up .......................................................................................................................................................................4-2
4.2.1. Power On.........................................................................................................................................................4-2
4.2.2. Standby or Power Off ................................................................................................................................4-5
4.3. C-Arm controls.........................................................................................................................................................4-6
4.3.1. C-Arm Control Panel ..................................................................................................................................4-6
4.3.2. Footswitch and Handswitch............................................................................................................... 4-14
4.3.3. Emergency Switch ................................................................................................................................... 4-16

Contents
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4.4. Workstation Controls.........................................................................................................................................4-17
4.4.1. Workstation Membrane Keyboard ..................................................................................................4-17
4.4.2. Touch Screen..............................................................................................................................................4-23
4.5. Image Quality Control .......................................................................................................................................4-23
Chapter5. Usual Operations..................................................................................5-1
5.1. Exam Management .............................................................................................................................................. 5-2
5.1.1. Create a New Exam................................................................................................................................... 5-2
5.1.2. Scheduled Exams Feature ..................................................................................................................... 5-3
5.1.3. Resume a Performed Exam................................................................................................................... 5-5
5.1.4. Edit Patient Information .......................................................................................................................... 5-6
5.2. Imaging Mode ......................................................................................................................................................... 5-7
5.2.1. Normal Fluoro Imaging............................................................................................................................ 5-9
5.2.2. High Level Fluoro Imaging ..................................................................................................................... 5-9
5.2.3. Digital Spot Imaging................................................................................................................................5-10
5.2.4. Pulsed Fluoro Imaging ...........................................................................................................................5-10
5.2.5. Low Dose Imaging ...................................................................................................................................5-11
5.2.6. Imaging Mode List....................................................................................................................................5-11
5.2.7. Modes of Operation: Engaging and Disengaging.....................................................................5-13
5.3. Image Review, Print and Archive .................................................................................................................5-13
5.3.1. Review Images...........................................................................................................................................5-13
5.3.2. Review Dose Information .....................................................................................................................5-17
5.3.3. Print, Export and Import........................................................................................................................5-24
5.3.4. Retrieve a Performed Exam.................................................................................................................5-29
5.4. Pediatric Use..........................................................................................................................................................5-29
5.4.1. General Instructions for Small or Pediatric Patients................................................................5-29
5.4.2. General Dose Planning ..........................................................................................................................5-30
5.5. Emergency Mode.................................................................................................................................................5-31
Chapter7. Radiographic Film.................................................................................7-1
7.1. Overview .................................................................................................................................................................... 7-2
7.2. Setup and Make a Film Exposure .................................................................................................................. 7-2
Chapter8. System Setup.........................................................................................8-1
8.1. System Information.............................................................................................................................................. 8-2
8.2. Date Time & Region .............................................................................................................................................. 8-3

Contents
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8.3. C-Arm System ..........................................................................................................................................................8-4
8.4. Security........................................................................................................................................................................8-5
8.5. Maintenance.............................................................................................................................................................8-7
Chapter9. Maintenance.......................................................................................... 9-1
9.1. Overview.....................................................................................................................................................................9-2
9.2. Performance Checks ............................................................................................................................................9-3
9.2.1. Mechanical Performance Check..........................................................................................................9-3
9.2.2. Electrical Performance Check...............................................................................................................9-3
9.2.3. Emergency Switch Performance Check...........................................................................................9-4
9.2.4. Fluoro Mode Performance Check........................................................................................................9-4
9.2.5. Film Mode Performance Check ............................................................................................................9-5
9.3. Cleaning and Disinfections................................................................................................................................9-6
9.3.1. Cleaning...........................................................................................................................................................9-6
9.3.2. Disinfections ..................................................................................................................................................9-7
9.4. Storage........................................................................................................................................................................9-8
9.4.1. Temporary Storage (less than 60 days)............................................................................................9-8
9.4.2. Long Term Storage or Shipment (60 days or more) ...................................................................9-8
9.5. Maintenance Schedule........................................................................................................................................9-9
9.5.1. User Routine Checks Items.....................................................................................................................9-9
9.5.2. Periodic Maintenance ............................................................................................................................ 9-10
Chapter10. Display Messages...............................................................................10-1
10.1. Overview..................................................................................................................................................................10-2
10.2. Error Recovery Steps .........................................................................................................................................10-2
10.3. Messages................................................................................................................................................................. 10-2
Chapter11. Labels and Symbols ........................................................................... 11-1
11.1. Overview..................................................................................................................................................................11-2
11.2. Labels and Locations.........................................................................................................................................11-2
11.2.1. Labels............................................................................................................................................................. 11-2
11.2.2. Locations of the Labels ...................................................................................................................... 11-15
11.3. Symbols................................................................................................................................................................. 11-17
Chapter12. Technical Reference...........................................................................12-1
12.1. Overview..................................................................................................................................................................12-2
12.2. System Specifications .......................................................................................................................................12-2

Contents
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12.2.1. Classification Type ...................................................................................................................................12-2
12.2.2. Environmental Requirements.............................................................................................................12-2
12.2.3. Power Requirements...............................................................................................................................12-3
12.2.4. Physical Specifications...........................................................................................................................12-4
12.3. Specification of Key Components................................................................................................................12-6
12.3.1. X-Ray Generator .......................................................................................................................................12-6
12.3.2. X-Ray Source Assembly.........................................................................................................................12-8
12.3.3. Grid ...............................................................................................................................................................12-11
12.3.4. Image Intensifier....................................................................................................................................12-11
12.3.5. Camera....................................................................................................................................................... 12-11
12.3.6. Others..........................................................................................................................................................12-11
12.4. Tube Rating Chart.............................................................................................................................................12-12
12.4.1. Filament Emission Characteristics................................................................................................12-12
12.4.2. Single Load Ratings .............................................................................................................................. 12-13
12.4.3. Thermal Characteristic .......................................................................................................................12-14
12.5. Scatter Radiation ..............................................................................................................................................12-15
12.6. Room Interface (RIF) ........................................................................................................................................12-21
12.7. Options................................................................................................................................................................... 12-22
12.7.1. Thermal/ Film Printers.........................................................................................................................12-22
12.7.2. Laser Aimer...............................................................................................................................................12-23
12.7.3. 30cm Skin Spacer..................................................................................................................................12-24
12.7.4. Film Cassette Holder............................................................................................................................12-25
12.7.5. Video Distributor ....................................................................................................................................12-25
12.7.6. Removable Filter ....................................................................................................................................12-25
12.7.7. Removable Grid...................................................................................................................................... 12-25
12.7.8. Wi-Fi Internet Adapter.........................................................................................................................12-26
12.8. Material Safety Data Sheets........................................................................................................................12-26
12.9. Material Recycling............................................................................................................................................12-26
12.10. Replacement Parts...........................................................................................................................................12-27
12.11. System Block.......................................................................................................................................................12-28

Chapter1. Introduction and Safety

Introduction and Safety
Page 1-2
1.1. Overview
This manual describes operation for Brivo OEC 715/785/865 Mobile C-Arm X-Ray 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.
The Brivo OEC 715/785/865 Mobile C-Arm X-Ray Product is designed to provide digital spot-film imaging
and fluoroscopic image guidance across all adult and pediatric populations for orientations between
patient anatomy and surgical instruments. The product is used for general surgical applications and
musculoskeletal procedures to visualize, for example, implant localization/s or needle positions for
aspirations, injections or biopsy. Not for interventional use.
Contraindications: pregnant or lactating women, persons who can’t tolerate surgery, persons who have
mental disorders and can’t cooperate in surgery, etc.
1.2. Owner Responsibilities
The owner has the responsibility to ensure system compatibility, operator qualifications and the continued
compliance of equipment and operating specifications. The owner has the responsibility to ensure that only
properly trained, qualified personnel who have obtained credentials from the appropriate authorities
operate the system. 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 HUALUN Medical Systems
Co, Ltd.
1.2.1. 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 uncertain it’s compatible.
1.2.2. 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.
1.2.3. 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.
International standards include the following but not limited:
•US Federal Performance standard 21CFR 1020.30; 21CFR 1020.31; 21CFR1020.32
•IEC 60601-1 1988 (2nd Edition) +Amd. 1 & Amd. 2/EN 60601-1 (1990) + Amd. 1 & Amd. 2, Medical
electric equipment Part 1: General requirements for safety
•IEC 60601-1-1 2000 2nd Edition, Medical electrical equipment Part 1-1 - Collateral Standard: Safety
Requirements for Medical Electrical Systems