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: 8610-58068888
Fax: 8610-67881850
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: +33 1 30 70 40 40
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
Page v
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
Page vi
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
Page vii
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
Page viii
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
Brivo OEC 715/785/865 Mobile C-Arm X-Ray Product
Page 1-3
•IEC 60601-1-2 (2001) & Amd. 1 (2004)/EN 60601-1-2 (2001) & Amd. 1 (2006), Medical electrical
equipment Part 1-2:Collateral standard: Electromagnetic compatibility –Requirements and tests
•IEC 60601-1-3 (1994)/EN 60601-1-3 (1994), MEDICAL ELECTRICAL EQUIPMENT Part 1-3: Collateral
Standard: General Requirements For Radiation Protection In Diagnostic X-Ray Equipment
•IEC 60601-1-4 (1996) & Amd. 1 (1999)/EN 60601-1-4 (1996) & Amd. 1 (1999), Medical electrical
equipment Part 1-4 - Collateral Standard: Programmable electrical medical systems
•IEC 60601-1-6 (2006)/EN 60601-1-6 (2007), Medical electrical equipment Part 1-6: General
requirements for safety - Collateral Standard: Usability
•IEC 60601-2-7 (1998)/EN 60601-2-7 (1998), Medical Electrical Equipment Part 2: Particular
requirements for the safety of high-voltage generators of diagnostic X-Ray generator
•IEC 60601-2-28 (1993)/EN 60601-2-28 (1993), Medical electrical equipment Part 2: Particular
requirements for the safety of X-Ray source assemblies and X-Ray tube assemblies for medical
diagnosis
•IEC 60601-2-32 (1994)/EN 60601-2-32 (1994), Medical electrical equipment Part 2: Particular
requirements for the safety of associated equipment of X-Ray equipment
•IEC 60601-1 (2005)/EN 60601-1 (2006), Medical electrical equipment Part 1: General requirements for
basic safety and essential performance
•IEC 60601-1-2 (2007)/EN 60601-1-2 (2007), Medical electrical equipment Part 1-2: Collateral standard:
Electromagnetic compatibility –Requirements and tests
•IEC 60601-1-3 (2008)/EN 60601-1-3 (2008), Medical electrical equipment Part 1-3: Collateral Standard:
Radiation protection in diagnostic X-Ray equipment
•IEC 60601-1-6 (2010)/EN 60601-1-6 (2010), Medical electrical equipment Part 1-6: Collateral standard:
Usability
•IEC 60601-2-43 (2010)/EN 60601-2-43 (2010), Medical electrical equipment Part 2-43: Particular
requirements for basic safety and essential performance of X-Ray equipment for interventional
procedures
•IEC 60601-2-28 (2010)/EN 60601-2-28 (2010), Medical electrical equipment Part 2-28: Particular
requirements for the basic safety and essential performance of X-Ray tube assemblies for medical
diagnosis
1.2.4. Unauthorized Modifications
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
Healthcare representative.
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.
CAUTION
Introduction and Safety
Page 1-4
1.3. Manufacturer's Responsibilities
GE HUALUN Medical Systems, Co. Ltd. certifies each system and X-Ray source assembly. After-sale
operating practices and safety are the responsibility of the owner/operator.
1.3.1. X-Ray Equipment Certification
GE HUALUN Medical Systems, Co. Ltd. certifies that when assembled according to manufacturer's
instructions, the X-Ray equipment complies with applicable international standards.
1.3.2. After-sale Operating and Safety Practices
GE HUALUN Medical Systems, Co. Ltd. assumes no responsibility or liability for personal injury or damage
resulting from misuse of its systems.
1.3.3. Essential Performance
In order to meet its intended use and comply with regulatory standards, the system provides the following
essential performances:
1. Patient/Image database integrity;
2. Acceptable fluoroscopic image quality;
3. Display & Indication of Last Image Hold (LIH) following termination of X-ray exposure;
4. Maintain X-ray tube voltage accuracy within 10%;
5. Ensure increment/decrement between two settings is within 50% to 150% of indicated change;
6. Maintain X-ray tube current accuracy within 20%;
7. Maintain current time product at +/- (10% + 0.2mAs);
8. The coefficient of variation of MEASURED VALUES of AIR KERMA is not greater than 0.05 for any
combination of LOADING FACTORS;
9. Linearity of AIR KERMA in RADIOGRAPHY is not greater than 0.2;
10. Automatic Brightness Stabilization (ABS) function implementing the Automatic Exposure Rate Control
feature;
11. Provide radiation dose structured report (RDSR) as per IEC/PAS 61910-1:2007.
1.4. 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 HUALUN Medical Systems, Co. Ltd. to request service. The communication center's
telephone and Fax numbers are listed below:
GE HUALUN MEDICAL SYSTEMS CO. Ltd.
No 1 Yong Chang North Road
Beijing Economic-Technological Development Zone
Beijing CHINA.
P.O.: 100176
Brivo OEC 715/785/865 Mobile C-Arm X-Ray Product
Page 1-5
WARNING
WARNING
Tel: 8610-58068888
Call center: 400-812-8188
European Representative:
GE Medical Systems S.C.S.
283 rue de la Minière
78530 BUC France
Tel: +33 1 30 70 40 40
You may also call or fax these numbers to order circuit diagrams, component part lists, calibration
instructions or other information which will assist qualified service engineers to repair the system.
1.5. 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.
The following pages describe hazardous and potentially hazardous conditions, and how to adequately
protect yourself and others from possible injury.
1.5.1. Safety Hazard Alerts
There are three hazard classifications, which are denoted and prioritized by the alert words:
WARNING indicates a potentially hazardous situation that, if not avoided, could result in
death or serious injury.
CAUTION indicates a potentially hazardous situation that, if not avoided, may result in
moderate to minor injury, equipment damage or loss of data.
NOTE is given in situation requiring special attention.
1.5.2. Explosion
The system is not designed for use in explosive atmosphere (e.g. anesthetic gases).
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 the equipment. Follow these guidelines:
Do not turn the system off or unplug it from the AC receptacle.
Do not operate any other electrically powered equipment.
CAUTION
NOTE
Introduction and Safety
Page 1-6
NOTE
Evacuate all personnel from the area and ventilate with fresh air. Avoid operating any automated
(electrically operated) doors or windows.
Contact your local fire department as soon as possible.
1.5.3. Equipment Stability and Positioning
Brivo OEC 715/785/865 Mobile C-Arm X-Ray Product is mounted on wheels. If it is moved or operated
improperly it could roll out of control. Follow these guidelines:
Two people should maintain control of the equipment when moving up or down an incline.
Place all mechanical assemblies in their most compact (transport) position and lock brake handles prior to
moving the equipment.
Use the handles designed for moving the equipment and mechanical assemblies.
Never attempt to move the system up or down steps.
Do not operate the equipment on unleveled floors.
Do not lock the wheel brakes and leave the equipment unattended on unleveled floors.
Always apply the wheel locks when the system is in its final position.
Do not move the equipment if the casters or wheels are not functioning properly.
Mechanical shocks to the equipment while disk drives are accessing information may cause damage to the
disk drive.
1.5.4. Motorized Mechanical Movement
Brivo OEC 715/785/865 Mobile C-Arm X-Ray Product has motorized mechanical assemblies. Please follow
these guidelines.
Always observe mechanical assemblies when operating the motor to avoid pinching or collision with a
person or object.
Be careful when working around equipment to avoid unintentional motor actuation. Do not carelessly place
objects on the equipment or bump or lean against the equipment.
Observe and prevent articles of clothing from getting caught in moving parts.
1.5.5. Improperly Attached Equipment
If your equipment accommodates a film cassette holder or some other piece of equipment that can be
attached or removed, follow these guidelines:
Use only equipment supplied by GE HUALUN Medical Systems Co. Ltd.
Attach the equipment properly. Incorrectly attached equipment could fall, causing injury to the patient or
operator.
Refer to Chapter 12 “Technical Reference” for the correct dimensions of items that may be
used in conjunction with this product, such as radiographic film cassettes.
Brivo OEC 715/785/865 Mobile C-Arm X-Ray Product
Page 1-7
WARNING
WARNING
Electrical circuits inside the equipment may use voltages that are capable of causing
serious injury or death from electric shock. To avoid this hazard, never remove any of the
system covers.
Brivo OEC 715/785/865 Mobile C-Arm X-Ray Product is not waterproof. If water, soap or
other liquids drip into the equipment, this can cause short circuit leading to electric shock
and fire hazards. If liquids are accidentally spilled into the system, do not power or turn on
the system until the liquids dry or evaporate completely.
To avoid risk of electric shock, this equipment must only be connected to a supply mains
with protective earth.
Observe the following safety procedures to avoid electric shock or serious injury to operators and patients
and to avoid system malfunction.
Make all electrical connections to equipment while outside the patient environment. Do not touch a
connector and the patient at the same time.
Do not bypass, jumper or otherwise disable the safety interlocks.
Do not remove any of the assembly covers.
Do not place food or beverage containers on any part of the equipment. If spilled they can cause short
circuits.
Always remove power to the equipment before cleaning. Use a slightly damp cloth or sponge for cleaning.
Only qualified service engineers are allowed to service or repair a system.
1.5.6. Electrical Fire
In the event of electrical fire perform the following emergency procedure:
Any emergency procedure developed by the owner, for the area in which the system is
used, should include these safety measures:
Remove electrical power to the system by placing the power switch in the off position.
Unplug the power cord from the AC receptacle.
Evacuate personnel from the area.
Only use a fire extinguisher that is approved for use on electrical fires.
Call your local fire department for help if necessary.
The use of the wrong type of fire extinguisher presents electrical shock and burn hazards.
To avoid these hazards, a fire extinguisher, which meets applicable regulations and
standards, must be available in the room where the equipment is being used.
WARNING
NOTE
WARNING
Introduction and Safety
Page 1-8
WARNING
WARNING
WARNING
1.5.7. Ground Fault
If the operating room has a ground fault alarm and the alarm is actuated:
Do not operate the system.
Call a qualified service technician.
1.5.8. Improper Access
Improper access into the cabinet and covers of the system may cause injury to your hand or
fingers. Do not put your hands or fingers into the cabinet or covers of the system.
1.6. Radiation Exposure
1.6.1. General Protection
This equipment either produces or is used in the vicinity of ionizing radiation. Observe
proper safety practices during operation.
The owner must designate areas suitable for safe operation and service of the equipment and ensure they
are only used in those areas.
The owner must ensure that all personnel wear appropriate protective clothing and radiation monitoring
devices while using the equipment.
Remain alert for visual indicators and audible alarms that are activated when ionizing radiation is being
produced by equipment in the work area.
1.6.2. Source-to-Skin Distance
International regulations specify that a minimum source-skin distance be maintained, except for specific
surgical applications. Brivo OEC 715/785/865 Mobile C-Arm X-Ray Product has a skin spacer attached in
order to meet this requirement. The system is prefabricated with a spacer for 30cm source-to-skin
distance.
Operator should keep as far as possible away from the X-Ray source.
Removing the skin spacer may result in increased radiation exposure to the patient. The
skin spacer can only be removed by the physician.
Brivo OEC 715/785/865 Mobile C-Arm X-Ray Product
Page 1-9
1.6.3. Dose to Patient
Skin Dose Levels
The skin dose levels in normal use may be high enough to cause deterministic effects. The availability of the different settings has a considerable
effect on the radiation quality, the delivered dose rate and the image quality.
Patient Entrance Reference Point
Air Kerma (Kinetic Energy Released per unit Mass, i.e. Dose) is an indication of the radiation delivered to the patient entrance reference point, a
point in space, and is measured in the units of Grays (Gy). The System determines the patient entrance reference point as a point along the central
X-ray beam axis 70cm from the focal spot (30cm from the image intensifier entrance).
Selection of the patient entrance reference point is based on international convention and typical usage of a multi-use mobile
fluoroscopy system. This point should represent a typical intersection of patient surface and the X-ray beam axis.
Radiation Data
The measurement is performed at patient entrance reference point. Following dosimetric data are typical values in normal use cases. There might
be with some tolerance in actual use cases.
The following data are for Brivo OEC 715, 785 with I.I.(23XZ4ST/BS).
Operation
Mode
Technique
Auto (PMMA 200mm)
Max
Pediatrics
With Grid, No Filter
With Filter, No Grid
With Grid, No Filter
With Filter, No Grid
Mag mode
Mag0
Mag1
Mag2
Mag0
Mag1
Mag2
Mag0/1/2
Mag0/1/2
Normal
Fluoro
kVp
80
81
80
72
73
74
110
110
mA
2.1
3
4
1.7
2.5
3.6
4
4
dose rate
(mGy/min)
10.33
15.17
19.67
3.36
5.15
7.70
38.87
24.29
High Level
Fluoro
kVp
81
81
80
72
73
74
110
110
mA
3.2
4.6
6.4
2.5
3.7
5.4
6
6
dose rate
(mGy/min)
16.18
23.26
31.48
4.94
7.62
11.56
58.30
36.43
NOTE
Introduction and Safety
Page 1-10
Low Dose
kVp
80
81
81
72
73
75
110
110
mA
1
1.4
1.8
0.8
1.1
1.7
2
2
dose rate
(mGy/min)
4.92
7.08
9.10
1.58
2.26
3.78
19.43
12.14
Low Dose
High Level
Fluoro
kVp
81
81
81
72
73
74
110
110
mA
1.5
2.1
3
1.2
1.7
2.5
2
2
dose rate
(mGy/min)
7.58
10.62
15.17
2.37
3.50
5.35
19.43
12.14
Pulsed
Normal
Fluoro
8pps
kVp
78
78
77
68
70
71
110
110
mA
2
2.8
3.9
1.5
2.2
3.3
4
4
dose rate
(mGy/min)
3.72
5.20
7.04
1.00
1.60
2.51
15.55
9.71
Pulsed
High Level
Fluoro
8pps
kVp
78
78
78
68
70
71
110
110
mA
3
4.2
6
2.3
3.3
4.5
6
6
dose rate
(mGy/min)
5.58
7.81
11.15
1.54
2.40
3.42
23.32
14.57
Pulsed Low
Dose 8pps
kVp
77
76
75
66
68
69
110
110
mA
0.9
1.2
1.7
0.6
0.9
1.4
2
2
dose rate
(mGy/min)
1.62
2.10
2.89
0.37
0.60
0.98
7.77
4.86
Pulsed Low
Dose High
Level
Fluoro
8pps
kVp
77
77
77
67
69
70
110
110
mA
1.3
1.8
2.6
1
1.5
2.1
2
2
dose rate
(mGy/min)
2.35
3.25
4.69
0.64
1.05
1.53
7.77
4.86
Pulse
Normal
Fluoro
4pps
kVp
78
78
77
68
70
71
110
110
mA
2
2.8
3.9
1.5
2.2
3.3
4
4
dose rate
(mGy/min)
1.86
2.60
3.52
0.50
0.80
1.25
7.77
4.86
Pulsed
High Level
kVp
78
78
78
68
70
71
110
110
mA
3
4.2
6
2.3
3.3
4.5
6
6
Brivo OEC 715/785/865 Mobile C-Arm X-Ray Product
Page 1-11
Fluoro
4pps
dose rate
(mGy/min)
2.79
3.90
5.58
0.77
1.20
1.71
11.66
7.29
Pulsed Low
Dose 4pps
kVp
77
76
75
66
68
69
110
110
mA
0.9
1.2
1.7
0.6
0.9
1.4
2
2
dose rate
(mGy/min)
0.81
1.05
1.44
0.18
0.30
0.49
3.89
2.43
Pulsed Low
Dose High
Level
Fluoro
4pps
kVp
77
77
77
67
69
70
110
110
mA
1.3
1.8
2.6
1
1.5
2.1
2
2
dose rate
(mGy/min)
1.17
1.62
2.35
0.32
0.52
0.76
3.89
2.43
Pulse
Normal
Fluoro
2pps
kVp
78
78
77
68
70
71
110
110
mA
2
2.8
3.9
1.5
2.2
3.3
4
4
dose rate
(mGy/min)
0.93
1.30
1.76
0.25
0.40
0.63
3.89
2.43
Pulsed
High Level
Fluoro
2pps
kVp
78
78
78
68
70
71
110
110
mA
3
4.2
6
2.3
3.3
4.5
6
6
dose rate
(mGy/min)
1.39
1.95
2.79
0.38
0.60
0.85
5.83
3.64
Pulsed Low
Dose 2pps
kVp
77
76
75
66
68
69
110
110
mA
0.9
1.2
1.7
0.6
0.9
1.4
2
2
dose rate
(mGy/min)
0.41
0.53
0.72
0.09
0.15
0.24
1.94
1.21
Pulse Low
Dose High
Level
Fluoro
2pps
kVp
77
77
77
67
69
70
110
110
mA
1.3
1.8
2.6
1
1.5
2.1
2
2
dose rate
(mGy/min)
0.59
0.81
1.17
0.16
0.26
0.38
1.94
1.21
Pulse
Normal
Fluoro
1pps
kVp
78
78
77
68
70
71
110
110
mA
2
2.8
3.9
1.5
2.2
3.3
4
4
dose rate
(mGy/min)
0.46
0.65
0.88
0.13
0.20
0.31
1.94
1.21
Pulsed
High Level
kVp
78
78
78
68
70
71
110
110
mA
3
4.2
6
2.3
3.3
4.5
6
6
Introduction and Safety
Page 1-12
Fluoro
1pps
dose rate
(mGy/min)
0.70
0.98
1.39
0.19
0.30
0.43
2.91
1.82
Pulsed Low
Dose 1pps
kVp
77
76
75
66
68
69
110
110
mA
0.9
1.2
1.7
0.6
0.9
1.4
2
2
dose rate
(mGy/min)
0.20
0.26
0.36
0.05
0.08
0.12
0.97
0.61
Pulsed Low
Dose High
Level
Fluoro
1pps
kVp
77
77
77
67
69
70
110
110
mA
1.3
1.8
2.6
1
1.5
2.1
2
2
dose rate
(mGy/min)
0.29
0.41
0.59
0.08
0.13
0.19
0.97
0.61
Digital Spot
kVp
110
110
mA
16
16
dose (mGy)
1.68
1.05
Film
kVp
110
110
mAs
80
80
dose (mGy)
12.96
8.10
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