OM OEC One Rev 9 - 2020

OEC OneTM
Mobile C-Arm X-Ray Product

Operator Manual
6888000-1EN
Rev.9
© 2020
General Electric Company
All rights reserved
Revision History
Revision History
Revision Date (Month & Year) Description of Change
1 Sep. 2017 Initial Release
2 Nov. 2017 Update Information
3 May 2018 Update Information
4 Nov. 2018 Update Information
5 Dec. 2019 Update Information
6 Apr. 2020 Update Information
7 Sep. 2020 Update Information
U.S. federal law restricts this device to sale by or on the order of a physician,
CAUTION
veterinarian, or other designated licensed practitioner as appropriate for its clinical use.
IMPORTANT SAVE THESE INSTRUCTIONS. PLEASE READ THIS MANUAL BEFORE USING OEC ONE 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 Yong Chang North Road
Beijing Economic Technological Development Zone
Beijing 100176 China
Tel: 8610-58068888
Fax: 8610-67881850
Page ii
REGULATORY REQUIREMENTS
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.
EU Authorized Representative:
GE Medical Systems S.C.S.
283 rue de la Minière
78530 BUC France
Tel: +33 1 30 70 40 40
Page iii
Contents
Contents
Chapter 1. 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.................................................................................................................................. 1-4
1.3. Manufacturer's Responsibilities ................................................................................................................................... 1-5
1.3.1. X-ray Equipment Certification ............................................................................................................................. 1-5
1.3.2. After-sale Operating and Safety Practices .................................................................................................... 1-5
1.3.3. Essential Performance............................................................................................................................................. 1-5
1.4. Communication Center Telephone Numbers ........................................................................................................ 1-6
1.5. Safety Hazards ..................................................................................................................................................................... 1-6
1.5.1. Safety Hazard Alerts ................................................................................................................................................. 1-6
1.5.2. Explosion ........................................................................................................................................................................ 1-7
1.5.3. Equipment Stability and Positioning ................................................................................................................. 1-7
1.5.4. Mechanical Movement ............................................................................................................................................ 1-7
1.5.5. Improperly Attached Equipment ........................................................................................................................ 1-8
1.5.6. Electrical Shock ........................................................................................................................................................... 1-8
1.5.7. Electrical Fire ................................................................................................................................................................ 1-8
1.5.8. Ground Fault ................................................................................................................................................................ 1-9
1.5.9. Improper Access......................................................................................................................................................... 1-9
1.6. Radiation Exposure ............................................................................................................................................................ 1-9
1.6.1. General Protection .................................................................................................................................................... 1-9
1.6.2. Source-Skin Distance ............................................................................................................................................. 1-10
1.6.3. Dose to Patient .......................................................................................................................................................... 1-11
1.6.4 Scattered Radiation ................................................................................................................................................. 1-15
1.7. Ingress of Fluids ................................................................................................................................................................. 1-21
1.7.1. Draping ......................................................................................................................................................................... 1-21
1.7.2. Communication center contact information ............................................................................................. 1-21
1.8. Cooling Efficiency .............................................................................................................................................................. 1-22
1.9. Burns ...................................................................................................................................................................................... 1-22
1.10. Electromagnetic Compatibility Statement ......................................................................................................... 1-23
1.11. Equipment Malfunction ............................................................................................................................................... 1-30
1.12. Mains Isolation ................................................................................................................................................................. 1-30
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Contents
1.13. External Devices ............................................................................................................................................................. 1-30

1.14. Patient Environment ..................................................................................................................................................... 1-31
1.14.1. Within the United States.................................................................................................................................... 1-31
1.14.2. Outside the United States ................................................................................................................................. 1-31
Chapter 2. System Overview .................................................................................. 2-1
2.1. General Description ............................................................................................................................................................ 2-2
2.2. System Components Overview ..................................................................................................................................... 2-3
Chapter 3. Mechanical Positioning & System Start Up ..................................... 3-1
3.1. Overview................................................................................................................................................................................... 3-2
3.2. Transport the System ........................................................................................................................................................ 3-2
3.3. Monitor Adjustment ............................................................................................................................................................ 3-4
3.4. TechView Tablet (Control Panel) Adjustment......................................................................................................... 3-6
3.5. Brake Pedal Positioning .................................................................................................................................................... 3-7
3.6. Positioning C-arm Movements .................................................................................................................................... 3-8
3.6.1. C-arm Orbital Rotation ............................................................................................................................................. 3-8
3.6.2. Lateral Rotation ........................................................................................................................................................... 3-9
3.6.3. Wig-wag....................................................................................................................................................................... 3-10
3.6.4. Vertical Column Operation.................................................................................................................................. 3-11
3.6.5. Horizontal Cross Arm ............................................................................................................................................. 3-12
3.6.6. C-arm Steering Handle ......................................................................................................................................... 3-13
3.7. Start Up .................................................................................................................................................................................. 3-13
3.7.1. Power On ..................................................................................................................................................................... 3-13
3.7.2. Power Off ..................................................................................................................................................................... 3-15
3.7.3. Emergency Switch................................................................................................................................................... 3-16
Chapter 4. System Control...................................................................................... 4-1
4.1. Overview................................................................................................................................................................................... 4-2
4.2. Monitor Controls ................................................................................................................................................................... 4-3
4.3. TechView Tablet (Control Panel).................................................................................................................................... 4-6
4.3.1. HOME .............................................................................................................................................................................. 4-7
4.3.2. IMAGE ........................................................................................................................................................................... 4-10
4.3.3. X-RAY ........................................................................................................................................................................... 4-13
4.4. Footswitch and Hand Switch ...................................................................................................................................... 4-15
Chapter 5. Exam Management .............................................................................. 5-1
5.1. Create a New Exam ............................................................................................................................................................ 5-2
5.2. Query Scheduled Exams ................................................................................................................................................... 5-3
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Contents
5.3. Resume Performed Exams ............................................................................................................................................. 5-5

5.4. Edit Patient Information ................................................................................................................................................... 5-6
5.5. Pediatric Patients and Small Patients Use .............................................................................................................. 5-7
5.5.1. Minimize pediatric and small patient doses ................................................................................................. 5-7
5.5.2. Imaging Recommendations for Small or Pediatric Patients ................................................................. 5-8
Chapter 6. Imaging................................................................................................... 6-1
6.1. Imaging Mode ....................................................................................................................................................................... 6-2
6.1.1. Normal Fluoro Imaging ........................................................................................................................................... 6-3
6.1.2. High Level Fluoro Imaging ..................................................................................................................................... 6-3
6.1.3. Digital Spot Imaging ................................................................................................................................................. 6-4
6.1.4. Pulsed Fluoro Imaging ............................................................................................................................................. 6-4
6.1.5. Low Dose Imaging ..................................................................................................................................................... 6-5
6.1.6. Extended Exposure Feature.................................................................................................................................. 6-5
6.1.7. Imaging Mode List ..................................................................................................................................................... 6-5
6.2. Image Process & Comparison ....................................................................................................................................... 6-7
6.3. Image Quality Control ....................................................................................................................................................... 6-8
Chapter 7. Image Review & Dose Information Management ........................... 7-1
7.1. Review Images...................................................................................................................................................................... 7-2
7.2. Review Dose Information ................................................................................................................................................ 7-5
7.3. Print, Export and Import ................................................................................................................................................... 7-6
7.4. Retrieve a Performed Exam ........................................................................................................................................... 7-8
Chapter 8. Image Annotation and Measurement .............................................. 8-1
8.1. Image Annotation ............................................................................................................................................................... 8-2
8.1.1. Mark Images................................................................................................................................................................. 8-3
8.1.2. Add Comments on Images .................................................................................................................................... 8-4
8.1.3. Crop an Image ............................................................................................................................................................. 8-5
8.2. Image Measurement ......................................................................................................................................................... 8-6
8.2.1. Calibration ..................................................................................................................................................................... 8-7
8.2.2. Distance Measurement ........................................................................................................................................... 8-7
8.2.3. Angle Measurement ................................................................................................................................................. 8-8
8.3. Zoom ...................................................................................................................................................................................... 8-10
Chapter 9. DICOM ..................................................................................................... 9-1
9.1. Overview .................................................................................................................................................................................. 9-2
9.2. DICOM Setup.......................................................................................................................................................................... 9-3
9.3. Worklist................................................................................................................................................................................... 9-11
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Contents
9.4. DICOM Print .......................................................................................................................................................................... 9-12

9.5. DICOM Storage and Commitment ............................................................................................................................ 9-13
9.6. Query and Retrieve........................................................................................................................................................... 9-14
9.7. MPPS ...................................................................................................................................................................................... 9-15
Chapter 10. Radiographic Film .............................................................................. 10-1
10.1. Overview ............................................................................................................................................................................. 10-2
10.2. Setup & Make a Film Exposure ................................................................................................................................ 10-2
Chapter 11. System Setup ....................................................................................... 11-1
11.1. System Information ....................................................................................................................................................... 11-2
11.2. Date, Time & Region ...................................................................................................................................................... 11-3
11.3. C-arm System .................................................................................................................................................................. 11-4
11.4. Exposure ............................................................................................................................................................................. 11-5
11.5. Security................................................................................................................................................................................ 11-6
11.5.1. Screen Saver ........................................................................................................................................................... 11-7
11.6. Maintenance ..................................................................................................................................................................... 11-8
11.7. Network Connection .................................................................................................................................................. 11-12
11.8. Login & Log off .............................................................................................................................................................. 11-12
Chapter 12. Maintenance and Quality Assurance ............................................. 12-1
12.1. Overview ............................................................................................................................................................................. 12-2
12.2. Quality Assurance(QA) Checks (Performance Check).................................................................................... 12-3
12.2.1. Items of User Routine Quality Assurance Checks ................................................................................. 12-3
12.2.2. Mechanical Performance Quality Assurance Check............................................................................ 12-5
12.2.3. Electrical Performance Quality Assurance Check ................................................................................. 12-5
12.2.4. System Emergency Switch Quality Assurance Check ......................................................................... 12-6
12.2.5. Fluoro Mode Performance Quality Assurance Check ......................................................................... 12-6
12.2.6. Film Mode Performance Quality Assurance Check .............................................................................. 12-7
12.2.7. Image Quality and Dosimetry Quality Assurance Checks ................................................................ 12-7
12.3. Periodic Maintenance ............................................................................................................................................... 12-17
12.4. Cleaning ........................................................................................................................................................................... 12-18
12.4.1. Approved Cleaning Agents ............................................................................................................................ 12-18
12.5. Storage ............................................................................................................................................................................. 12-20
12.5.1. Temporary Storage (less than 60 days) .................................................................................................. 12-20
12.5.2. Long Term Storage or Shipment (60 days or more) .......................................................................... 12-20
Chapter 13. Display Messages ............................................................................... 13-1
13.1. Overview ............................................................................................................................................................................. 13-2
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Contents
13.2. Error Recovery Steps ..................................................................................................................................................... 13-2

13.3. Messages ............................................................................................................................................................................ 13-2
13.4. Virtual Keyboard ............................................................................................................................................................. 13-3
Chapter 14. Labels and Symbols ............................................................................ 14-1
14.1. Overview ............................................................................................................................................................................. 14-2
14.2. Labels and Locations .................................................................................................................................................... 14-2
14.2.1. Labels .......................................................................................................................................................................... 14-2
14.2.2. Locations of the Labels ................................................................................................................................... 14-16
14.3. Symbols ............................................................................................................................................................................ 14-18
Chapter 15. Technical Reference ........................................................................... 15-1
15.1. Overview ............................................................................................................................................................................. 15-2
15.2. System Specifications................................................................................................................................................... 15-2
15.2.1. Classification Type ................................................................................................................................................ 15-2
15.2.2. Environmental Requirements.......................................................................................................................... 15-2
15.2.3. Power Requirements ........................................................................................................................................... 15-3
15.2.4. Physical Specifications ....................................................................................................................................... 15-4
15.3. Specification of Key Components........................................................................................................................... 15-5
15.3.1. X-ray Generator ..................................................................................................................................................... 15-5
15.3.2. X-ray Source Assembly....................................................................................................................................... 15-8
15.3.3. Others ...................................................................................................................................................................... 15-10
15.4. Tube Rating Chart........................................................................................................................................................ 15-11
15.4.1. Filament Emission Characteristics ............................................................................................................. 15-11
15.4.2. Single Load Ratings ........................................................................................................................................... 15-12
15.5. Tube Thermal Characteristic .................................................................................................................................. 15-13
15.6. Room Interface (RIF) ................................................................................................................................................... 15-14
15.7. Options and Accessories .......................................................................................................................................... 15-15
15.7.1. Wireless Module .................................................................................................................................................. 15-15
15.7.2. 30cm Skin Spacer............................................................................................................................................... 15-17
15.7.3. Removable Grid ................................................................................................................................................... 15-18
15.7.4. Removable Filter ................................................................................................................................................. 15-18
15.7.5. Video Distributor ................................................................................................................................................. 15-19
15.7.6. Laser Aimer ........................................................................................................................................................... 15-19
15.7.7. Film Cassette Holder ......................................................................................................................................... 15-22
15.8. Material Recycling ....................................................................................................................................................... 15-23
15.9. Replacement Parts...................................................................................................................................................... 15-23
15.10. System Block ............................................................................................................................................................... 15-24
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Contents
Chapter 16. Privacy and Security .......................................................................... 16-1

16.1. Privacy and Security Environment ......................................................................................................................... 16-2
16.1.1. Network Connectivity.......................................................................................................................................... 16-2
16.1.2. Network Interconnections ................................................................................................................................ 16-2
16.2. Privacy and Security Capabilities ........................................................................................................................... 16-3
16.2.1. Access Controls...................................................................................................................................................... 16-3
16.2.2. Audit Logging .......................................................................................................................................................... 16-4
16.3. Information Protection ................................................................................................................................................ 16-4
16.3.1. Network Security ................................................................................................................................................... 16-4
16.3.2. Wireless Network Security – Wireless Operation .................................................................................. 16-5
16.3.3. Removable Media Security ............................................................................................................................... 16-6
16.3.4. Data at Rest Security........................................................................................................................................... 16-6
16.3.5. Data Integrity Capabilities ................................................................................................................................ 16-7
16.3.6. De-Identification Capabilities .......................................................................................................................... 16-7
16.3.7. Business Continuity .............................................................................................................................................. 16-7
16.3.8. Security Controls provided by the Cloud Provider ................................................................................ 16-7
16.4. Syestem Protection ....................................................................................................................................................... 16-8
16.4.1. Malicious Software Protection ........................................................................................................................ 16-8
16.4.2. System Security ..................................................................................................................................................... 16-8
16.4.3. Security Vulnerability Scanning ..................................................................................................................... 16-9
16.4.4. System (Product) Change Management .................................................................................................... 16-9
16.5. Personal Information Collected By The Product .......................................................................................... 16-10
16.6. Additional Privacy and Security Considerations .......................................................................................... 16-10
Appendix：Operator Manual Supplement............................................................ A-1
Page ix
Chapter 1. Introduction and Safety
Introduction and Safety
1.1. Overview
This manual describes operations for the OEC One 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.
Intended use: The OEC One mobile C-arm system is intended to provide fluoroscopic and digital spot/film
images of the patient anatomy, interventional tools/devices, and/or contrast agents during diagnostic,
interventional, and surgical procedures.
Indication for use: The OEC One mobile C-arm system is designed to provide fluoroscopic and digital
spot/film images of adult and pediatric patient populations during diagnostic, interventional, and surgical
procedures. Examples of a clinical application may include: orthopedic, gastrointestinal, endoscopic,
urologic, neurologic, critical care, and emergency procedures.
Contraindications: None known
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 Healthcare.
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 about it’s compatibility.
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.
This equipment conforms with the following International standards with valid version(s) but not limited:
• US Federal Performance standard 21CFR 1020.30; 21CFR 1020.31; 21CFR1020.32
• IEC 60601-1: 2005 +Corr.1 (2006) + Corr.2 (2007) + AM1 (2012), Medical electrical equipment Part 1:
General requirements for basic safety and essential performance
• IEC 60601-1-2: 2007 and IEC 60601-1-2: 2014, Medical electrical equipment Part 1-2: Collateral
standard: Electromagnetic compatibility –Requirements and tests
Page 1-2
OEC One Mobile C-arm X-ray Product
• IEC 60601-1-3: 2008 and IEC 60601-1-3: 2008 + A1:2013, Medical electrical equipment Part 1-3:
Collateral Standard: Radiation protection in diagnostic X-ray equipment
• IEC 60601-1-6: 2010 and IEC 60601-1-6:2013, Medical electrical equipment Part 1-6: Collateral
standard: Usability
• IEC 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 60601-2-54: 2009 and IEC 60601-2-54: 2009+A1:2015, Medical electrical equipment Part 2-54:
Particular requirements for the basic safety and essential performance of X-ray equipment for
radiography and radioscopy
• IEC 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
• ANSI/AAMI ES60601-1:2005/(R)2012, AND C1:2009 AND A2:2010(R)2012 (CONSOLIDATED TEXT), Medical
electrical equipment - Part 1: General requirements for basic safety and essential performance
• CAN/CSA-C22.2 No. 60601-1:14, Medical Electrical Equipment - Part 1: General Requirements for Basic
Safety and Essential Performance (Adopted IEC 60601-1:2005 edition 3.0 + AMENDEMENT 1, 2012-07,
MOD)
• IEC62304:2006 and IEC62304:2006+A1:2015, Medical device software –Software life cycle processes
• IEC62366: 2007 and IEC62366: 2007+A1: 2014, Medical devices – Application of usability engineering to
medical devices
• IEC60825-1: 2007, Safety of laser products –Part 1: Equipment classification and requirements
Page 1-3
Wireless Regulatory Information for EU

Wireless Parts Included
The following wireless parts are included in this product:
Item Name Function GE P/N Frequency Band Transmit Power

(EU)
1 Wireless Wireless network 6888961 2.4GHz, 5GHz <20 dBm (2.4GHz)

Module connection for DICOM <23 dBm (5 GHz )
The wireless module parts come with the following system software versions:
Item Name System software release version
1 Wireless Module 1
Technical specifications of wireless DICOM module:

About the technical specifications and encryption mechanism, please refer to section 15.
5150-5350MHz frequency range is restricted to indoor use only, Outdoor operation in this range is
prohibited.
Declaration of Conformity (for RED)
The wireless module listed above is CE marked according to the provisions of the RED Directive
(2014/53/EU) when the system and wireless module attached the CE mark.
The following information is applicable when the system and wireless module attached the CE mark:
GE HUALUN Medical Systems Co. Ltd, here by declares that the system is in compliance with the essential
requirements and other relevant provisions of Directive 2014/53/EU.
The Declarations of Conformity made under Directive 2014/53/EU are available on the website:
http://www3.gehealthcare.com/en/Global_Gateway
A file compression/archival (zip/unzip) utility must be installed on the user’s computer.
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 GE Healthcare
authorized service engineer.
Page 1-4
1.3. Manufacturer's Responsibilities

GE Healthcare 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 Healthcare 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 Healthcare 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 Dose Rate
Control feature;
11. Provide radiation dose structured report (RDSR) as per IEC/PAS 61910-1:2007.
Page 1-5
1.4. Communication Center Telephone

Numbers
If the system does not operate properly or fails to respond to the controls as described in the operator
manual, call GE Healthcare 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 100176, China
Tel: 8610-58068888
Call center: 400-812-8188
European Representative:
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 in repairing 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
WARNING
death or serious injury.
CAUTION CAUTION indicates a potentially hazardous situation that, if not avoided, may result in
moderate to minor injury, equipment damage or loss of data.
NOTE NOTE is given in situation requiring special attention.
Page 1-6
1.5.2. Explosion
The system is not designed for use in an explosive atmosphere (e.g. flammable anesthetics
WARNING mixture with air or oxygen or nitrous oxide), otherwise there may be possible risk of fire/
explosion.
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. If so, follow these guidelines:
- Do not turn the system off or unplug it from the AC receptacle.
- Do not operate any other electrically powered equipment.
- 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

The system is mounted on wheels. If it is moved or operated improperly it could roll out of control. Follow
these guidelines:
Suggest two people to 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 (please refer to Chapter 3 for more details).
Always lock the spring arm and swing arm during transport.
Use the system handles for moving the equipment and mechanical assemblies.
Never attempt to move the system up or down steps.

WARNING Do not operate the equipment on unleveled floors.
Do not lock the wheel brakes and leave the equipment unattended on unleveled floors or
inclines.
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. Mechanical Movement

OEC One Mobile C-arm X-ray Product has moving parts such as C-arm and monitor. Please follow the
guidelines below:
Always use special caution in relation to the mechanical assemblies when operating the C-arm and
monitor to avoid pinching or collision with a person or object.
Be careful when working around equipment to avoid unintentional movement 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.
Page 1-7
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 and accessories approved by GE Healthcare.
Read and follow all instructions for attaching and detaching equipment.
Attach the equipment or accessories properly. Incorrectly attached equipment or

WARNING accessories could fall, causing injury to the patient or operator.
1.5.6. Electrical Shock

Electrical circuits inside the equipment may use voltages which are capable of causing
WARNING serious injury or death from electric shock. To avoid this hazard, never remove any of the
cabinet covers.
OEC One Mobile C-arm X-ray Product is not waterproof. If water, soap or other liquids drip
into the equipment, this can cause a short circuit leading to electric shock and fire hazards.
WARNING
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 an appropriate
WARNING grounded electrical outlet.
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.
Only GE Healthcare authorized service engineer can service or repair the system.
1.5.7. 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
NOTE used, should include these safety measures:
Unplug the power cord from the AC receptacle. Press the emergency switch.
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.
Page 1-8
The use of the wrong type of fire extinguisher presents electrical shock and burn hazards.
WARNING 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.
1.5.8. Ground Fault

If the operating room has a ground fault alarm and the alarm is actuated.
Do not operate the system.

WARNING
Call GE Healthcare authorized service engineer.
1.5.9. Improper Access

Improper access into the cabinet and covers of the system may cause injury to your hand or
WARNING 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. Risks and
WARNING dangers are inherent in the operation of this equipment. This equipment should only be
used by personnel properly trained and authorized in the use 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 use
only in those areas.
The owner must ensure that all personnel wear appropriate protective clothing and radiation monitoring
devices while using the equipment or working in the area around the equipment.
The owner must remain alert for visual indicators and audible alarms that are activated when ionizing
radiation is being produced by equipment in the work area.
The owner must set proper Dose Warning Threshold: For each exam, the operator can select a Cumulative
Air Kerma from 100-2200 mGy in 100 mGy steps (10-220 Rad in 10 Rad steps). If the threshold is reached, a
distinctive beeping sound will alert the operator.
Emergency switch is provided on the system to stop X-rays immediately if needed. This red switch is
located on the top cover. Reset the emergency switch after ensuring that no hazard exists.
The owner is responsible for obtaining any needed state/local licensing requirement for X-ray systems;
establishment of a radiation worker safety program; operator training; ensuring only qualified personnel
are authorized to operate the system; accreditation; and performance of preventative maintenance and
quality control to ensure the system continues to function within specification.
Page 1-9
1.6.2. Source-Skin Distance

Regulations specify that a minimum source-skin distance to be maintained, with a reduced distance
exception for special surgical procedures. The system maintains a minimum source -skin distance of 30 cm
when the skin spacer is attached to the collimator cover. Where allowed, the skin spacer may be removed
for special procedures. When removed, the collimator cover maintains a minimum source -skin distance of
20 cm.
Operator should keep as far away as possible from the X-ray source to avoid overexposure
WARNING hazards.
The patient should be positioned as far away from the X-ray source as possible in order to
keep the absorbed dose to the patient as low as reasonably achievable.
Removing the skin spacer may result in increased radiation exposure to the patient. The skin
spacer should only be removed on the instructions of a physician and should be reattached
to the collimator cover immediately following the procedure.
Page 1-10
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.
Biological Deterministic Effects of Radiation
Biological effects of any radiation should be divided into low and high levels. During most procedures, the effects of patient irradiation are low.
High levels of radiation directed at the same patient skin area for a prolonged period of time may cause deterministic effect. To minimize this risk
without adversely affecting the clinical objectives of the procedure, it is currently admitted that precautions should be taken when skin dose in a
certain location can exceed 1 Gy.
GE Healthcare equipment includes dose limitation mechanisms. In particular, the conventional entrance skin dose rate is maintained below 100
mGy/min, or at a lower level depending on local regulation, in a plane representative of patient skin dose, and positioned across the Patient
Entrance Reference Point. Therefore, in this plane, the value of 1 Gy may be reached in an accumulative exposure time of 10 minutes or more of
fluoroscopy.
In configurations required for some specific surgical examinations, patient skin could be significantly closer to the X-ray source, with dose rate
increased as the inverse square of the distance.
In case of long procedures and/or when X-ray is focused on a single location, use reduced dose techniques in order to reduce risk
CAUTION of patient injury due to ionizing radiation.
If clinically possible, avoid long exposures to help prevent radiation overexposure hazards.
Keep the radiation field as small as possible without reducing the active imaging field.
Fluoroscopy and digital spot involve the use of ionizing radiation and, therefore, x-ray is relatively contraindicated in pregnant
NOTE women due to potential harmful effects on a developing fetus. As in any medically justified clinical intervention, the potential risks
to any patient population and age must outweigh the intended benefits.
Page 1-11
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 between the focal spot and the center of the image intensifier entrance. This point is located 30 cm above the surface of the gird,
which is 70 cm from the focal spot.
Selection of the patient entrance reference point is based on international convention and typical usage of a multi-use mobile
NOTE
fluoroscopy system. This point should represent a typical intersection of patient surface on the X-ray beam axis.
Without Filter, With Grid With Filter, Without Grid

Imaging Mode Auto mode Auto mode
Max. Max.
(20cm PMMA) (20cm PMMA)
Field Size 9" 6" 4.5" 9" 6" 4.5"
Continuous kVp/mA 81/2.1 83/3.2 85/4.0 110/4.0 71/1.7 74/2.5 77/3.9 110/4.0
AKR(mGy/min) 10.51 16.61 22.05 38.11 2.443 4.06 7.08 20.7
8pps kVp/mA 82/2.2 84/3.3 87/4.0 110/4.0 72/1.7 75/2.6 78/4.0 110/4.0
AKR(mGy/min) 4.837 7.67 9.75 16.49 1.107 1.853 3.028 8.28
4pps kVp/mA 82/2.2 84/3.3 87/4.0 110/4.0 72/1.7 75/2.6 78/4.0 110/4.0
Normal
AKR(mGy/min) 2.479 3.887 5.118 8.476 0.575 0.973 1.556 4.166
2pps kVp/mA 82/2.2 84/3.3 87/4.0 110/4.0 72/1.7 75/2.6 78/4.0 110/4.0
AKR(mGy/min) 1.24 2.008 2.671 4.341 0.301 0.51 0.806 2.094
1pps kVp/mA 82/2.2 84/3.3 87/4.0 110/4.0 72/1.7 75/2.6 78/4.0 110/4.0
AKR(mGy/min) 0.625 0.968 1.294 2.125 0.147 0.245 0.399 1.031
Field Size 9" 6" 4.5" 9" 6" 4.5"
AKR(mGy/min) 14.28 23.36 38.51 57.02 3.377 6.154 9.694 30.88
HLF
8pps kVp/mA 79/3.1 83/4.8 86/7.4 110/6.0 71/2.5 74/3.8 77/5.9 110/6.0
AKR(mGy/min) 6.215 10.53 17.2 24.16 1.468 2.569 4.338 12.75
Page 1-12
4pps kVp/mA 79/3.1 83/4.8 86/7.4 110/6.0 71/2.5 74/3.8 77/5.9 110/6.0
AKR(mGy/min) 3.193 5.42 8.871 12.261 0.757 1.311 2.262 6.583
2pps kVp/mA 79/3.1 83/4.8 86/7.4 110/6.0 71/2.5 74/3.8 77/5.9 110/6.0
AKR(mGy/min) 1.641 2.793 4.54 6.312 0.384 0.667 1.18 3.422
1pps kVp/mA 79/3.1 83/4.8 86/7.4 110/6.0 71/2.5 74/3.8 77/5.9 110/6.0
AKR(mGy/min) 0.795 1.387 2.194 3.176 0.19 0.332 0.577 1.658
Field Size 9" 6" 4.5" 9" 6" 4.5"
AKR(mGy/min) 4.902 7.158 9.543 19.23 1.143 1.744 2.872 10.42
8pps kVp/mA 82/1.0 82/1.4 85/1.8 110/2.0 73/0.8 74/1.2 76/1.7 110/2.0
AKR(mGy/min) 2.483 3.344 4.497 8.96 0.577 0.843 1.309 4.783
4pps kVp/mA 82/1.0 82/1.4 85/1.8 110/2.0 73/0.8 74/1.2 76/1.7 110/2.0
Low dose AKR(mGy/min) 1.255 1.706 2.309 4.687 0.29 0.431 0.682 2.469
2pps kVp/mA 82/1.0 82/1.4 85/1.8 110/2.0 73/0.8 74/1.2 76/1.7 110/2.0
AKR(mGy/min) 0.63 0.862 1.156 2.422 0.148 0.216 0.353 1.244
1pps kVp/mA 82/1.0 82/1.4 85/1.8 110/2.0 73/0.8 74/1.2 76/1.7 110/2.0
AKR(mGy/min) 0.314 0.428 0.57 1.206 0.073 0.107 0.174 0.607
Field Size 9" 6" 4.5" 9" 6" 4.5"

AKR(mGy/min) 7.162 11.19 16.77 28.66 1.679 2.73 4.379 15.51
8pps kVp/mA 82/1.5 84/2.2 86/3.3 110/3.0 72/1.1 75/1.8 77/2.6 110/3.0
AKR(mGy/min) 3.467 5.32 7.73 12.76 0.81 1.289 1.949 6.71
HLF Low 4pps kVp/mA 82/1.5 84/2.2 86/3.3 110/3.0 72/1.1 75/1.8 77/2.6 110/3.0
Dose AKR(mGy/min) 1.749 2.718 3.957 6.649 0.411 0.66 1.02 3.476
2pps kVp/mA 82/1.5 84/2.2 86/3.3 110/3.0 72/1.1 75/1.8 77/2.6 110/3.0
AKR(mGy/min) 0.885 1.409 2.048 3.444 0.213 0.344 0.533 1.769
1pps kVp/mA 82/1.5 84/2.2 86/3.3 110/3.0 72/1.1 75/1.8 77/2.6 110/3.0
AKR(mGy/min) 0.435 0.687 1.003 1.734 0.104 0.166 0.258 0.888
Field Size 9" 6" 4.5" 9" 6" 4.5"
Page 1-13
Digital Continuous kVp/mA N/A N/A N/A 110/20 N/A N/A N/A 110/20
Spot AKR(mGy/min) N/A N/A N/A 178.32 N/A N/A N/A 98.74
Field Size 9" 6" 4.5" 9" 6" 4.5"
Continuous kVp/mAs N/A N/A N/A 110/80 N/A N/A N/A 110/80
Film
AKR(mGy/min) N/A N/A N/A 177.78 N/A N/A N/A 97.14
Page 1-14
1.6.4 Scattered Radiation

Significant Zones of Occupancy
The significant zones of occupancy and the stray radiation in this zone is shown below according to clause
13.4 and 13.6 in IEC 60601-1-3:2013.
Stray Radiation in Significant Zones of Occupancy
Test condition：
C-arm vertical; X-ray source assembly at the bottom; with scattered radiation grid; without removable filter
Phantom: 30(Length) X 30(Width) X 15cm(Thickness) PMMA
X-ray field: 9”; Continuous fluoroscopy at 110kVp/4mA and 70kVp/3mA.
Page 1-15
Page 1-16
Horizontal & Vertical Plane Test

This test is performed at continuous fluoroscopy mode in 95kVp/3mA, without protective device.
Test condition:
C-arm vertical; X-ray source assembly at the bottom; with scattered radiation grid; without removable filter
Phantom: 30(Length)*30(Width)*25cm(Thickness) PMMA; 9” X-ray field
Horizontal Plane
The following illustration shows measurement points in a plane perpendicular to the beam axis at a
height indicated by reference point C1. The measurement points are 25 cm apart. C1 is the patient
entrance reference point at which SSD is 70cm, and is illustrated in the Vertical Plane illustration below.
The table following the illustration shows expected scatter radiation at each point.
Measurement Dose Rate (mGy/h)

Point
Entrance exposure rate: 1314 mGy/h (95kVp @ 3.0mA)
H1 9.91
H2 1.95
H3 0.75
H4 0.37
S1 7.95
S2 3.31
S3 1.14
S4 0.64
Page 1-17
Vertical Plane
The following illustration shows measurement points in a plane through the beam axis at a height
indicated by reference point C1. The measurement points are 25 cm apart. C1 is the patient entrance
reference point at which SSD is 70cm, the table following the illustration shows expected scatter
radiation at these points.
Measurement Dose Rate (mGy/h)

Point
Entrance exposure rate: 1314 mGy/h (95kVp @ 3.0mA)
T1 8.41
T2 1.71
T3 0.87
T4 0.53
B1 19.2
B2 2.41
B3 1.28
B4 0.61
Page 1-18
ISO Kerma Map Test

This test method is according to clause 203.13.4 in EN 60601-2-43:2010.
The measurement is performed at 2 planes at typical height: 1m & 1.5m from the ground when the system
on normal mode 110kV, 4mA.
The operation table surface is 1m height above the floor.
Phantom dimension: 30cm (Length) x 30cm (Width) x 25cm (Height), The phantom is just placed on the
operation table and centered to X-Ray beam.
ISO Kerma Maps are tested under two typical configurations, one with the X-RAY BEAM horizontal and one
with the X-RAY BEAM vertical.
For the vertical configuration, the C arm is positioned with Monoblock down and detector up. The image
intensifier is 10cm above the phantom.
For the lateral configuration, the C arm is positioned wit the C arc perpendicular to the floor and the X-RAY
BEAM is horizontal. The image intensifier is 10cm from the phantom.
ISO kerma curves are given by μGy/Gy*cm2.
The layout is as below:
Vertical configuration Horizontal configuration
Page 1-19
Lateral configuration, 1.5m: Lateral configuration, 1m:
Vertical configuration, 1.5m: Vertical configuration, 1m:
Page 1-20
1.7. Ingress of Fluids

The X-ray system is not rated for water-tight operation. If liquids drip into the equipment,
WARNING disconnect the power cord and do not operate the system until it can be cleaned and
inspected by a qualified service engineer.
Excessive amounts of fluids such as antiseptics, cleaning solutions or bodily fluids may damage internal
components if they are allowed inside the equipment and may require unplanned service that is not
covered by the standard planned maintenance contract coverage. Use drapes to protect equipment when
performing procedures and do not apply excessive amounts of fluid when cleaning.
1.7.1. Draping
If you are performing a procedure where draping is necessary, cover the C-arm using a sterile draping
system. Custom fit, single-use sterile drapes that have been specifically designed for the OEC One C-arm
can be purchased from GE Healthcare. See 1.7.2 Communication center contact information to order any
consumables.
If you are performing a procedure where draping is necessary, drape the C-arm appropriately. Replace
drapes after each use.
Refer to the instructions provided with the draping system for details on how to drape the system.
1.7.2. Communication center contact information

Phone
1. Call the number that corresponds to your geographical location.
US: +1-800-874-7378
Canada: +1-800-668-0732
All other locations: Contact your local sales representative.
2. Establish an account with the customer service representative.
3. Place your order.
You may also call these numbers to order circuit diagrams, component part lists, calibration instructions,
arrange training, or obtain other information which will help qualified service engineers to repair your
system.
FAX
If you have a catalog and a GE Fax Order form, complete the form and fax it to +1-801-355-8114. If you do
not have a catalog, you can obtain one by dialing the number listed for your geographical location.
Page 1-21
1.8. Cooling Efficiency

The system does not require any special cooling methods; natural cooling is necessary.
Draping the system may restrict airflow to components that provide heat sinking and to vents designed to
cool the equipment. Drape equipment and cover vents only when exposure to excessive fluids is
unavoidable and extended use of the equipment is not required.
1.9. Burns
Extended use of imaging equipment may cause components such as X-ray tubes to reach temperatures
capable of inflicting burns. Use care when positioning equipment to avoid placing hot components near
patients and personnel. An anesthetized or unconscious patient is incapable of sensing and reacting to a
hot component.
Page 1-22
1.10. Electromagnetic Compatibility Statement

This product conforms with IEC60601-1-2 Ed3.0 and Ed4.0 EMC standard for medical devices.
This equipment generates, uses, and can radiate radio frequency energy. The equipment
NOTE may cause or be subject to radio frequency interference with other medical and
non–medical devices and radio communications. There may be RISKS of reciprocal
interference posed by ME EQUIPMENT during specific investigations and treatments. To
provide reasonable protection against such interference, the OEC One Mobile C-arm X-ray
Product system complies with emissions limits for a Group 1, Class A Medical Devices and
has applicable immunity level as stated in IEC60601-1-2.
However, there is no guarantee that interference will not occur in a particular installation.
The OEC One system needs special precautions regarding EMC and needs to be installed
and put into service according to the EMC information provided in the OEC One Operator
Manual.
Portable and mobile RF communication equipment can affect system. Keep the power to
these RF sources turned off when near this equipment. Recommended separation distances
and information regarding compatibility with other equipment are located in the EMC
Declaration Table as below.
If this equipment is found to cause interference (which may be determined by switching the
equipment on and off), the operator (or qualified service personnel) should attempt to
correct the problem by one or more of the following measure(s):
1. Reorient or relocate the affected device(s).
2. Increase the separating space between the equipment and the affected device.
3. Power the equipment from a source different from that of the affected device.
4. Consult the point of purchase or service representative for further suggestions.
Use of accessories, transducers and cables other than those specified or provided by the
WARNING manufacturer of this equipment could result in increased electromagnetic emissions or
decreased electromagnetic immunity of this equipment and result in improper operation.
The manufacturer is not responsible for any interference caused either by the use of cables
other than those recommended, or unauthorized changes or modifications to this
equipment. Unauthorized changes or modifications could void the operator’s authority to
operate the equipment.
Use of this equipment adjacent to or stacked with other equipment should be avoided
WARNING because it could result in improper operation. If such use is necessary, this equipment and
the other equipment should be observed to verify that they are operating normally.
This equipment may be interfered with by other equipment, even if that equipment
WARNING complies with CISPR EMISSON requirements.
Page 1-23
To comply with the regulations applicable to an electromagnetic interface for a Group 1,

NOTE Class A Medical Device, and to minimize interference risks, the following requirements shall
be applied:
1. All cables to peripheral devices must be shielded and properly grounded. The use of
cables that are not properly shielded and grounded may result in the equipment
causing radio frequency interference in violation of the European Union Medical
Device directive and FCC regulations.
2. All of the recommended guidance regarding electromagnetic environment shall be
followed.
Guidance and manufacturer’s declaration – Electromagnetic Emissions

The OEC One Mobile C-arm X-ray Product is intended to use in the specified electromagnetic
environment. The purchaser or operator of the OEC One Mobile C-arm X-ray Product should assure
that it is used in an electromagnetic environment as described below:
Emissions Test Compliance Electromagnetic Environment Guidance
RF Emissions The OEC One Mobile C-arm X-ray Product uses RF
Mains terminal energy only for its internal function. Therefore, its RF
Group1
disturbance voltage emissions are very low and are not likely to cause any
interference in nearby electronic equipment.
(Conducted Emissions)
CISPR 11 The OEC One Mobile C-arm X-ray Product is suitable for
use in all establishments other than domestic and
Class A
those directly connected to the public low-voltage
power supply network that supplies buildings used for
domestic purposes.
RF Emissions The OEC One Mobile C-arm X-ray Product uses RF
energy only for its internal function. Therefore, its RF
Electromagnetic Group1
emissions are very low and are not likely to cause any
radiation disturbance
interference in nearby electronic equipment.
(Radiated Emissions)
The OEC One Mobile C-arm X-ray Product is suitable for
CISPR 11
use in all establishments other than domestic and
Class A
those directly connected to the public low-voltage
power supply network that supplies buildings used for
Harmonic emissions Not domestic purposes.
applicable
IEC 61000-3-2
Voltage fluctuations/ Not
flicker emissions applicable
IEC 61000-3-3
Page 1-24
Guidance and manufacturer’s declaration - Electromagnetic Immunity

The OEC One Mobile C-arm X-ray Product is intended to use in the electromagnetic environment specified
below. The purchaser or operator of the OEC One Mobile C-arm X-ray Product should assure that it is used
in an electromagnetic environment as described below:
Immunity Test IEC 60601 Compliance Level Electromagnetic
Environment Guidance
Test Level
Electrostatic 8 kV contact 8 kV contact Floors are wood, concrete, or
discharge (ESD) ceramic tile, or floors are
15 kV air 15 kV air covered with synthetic material
IEC 61000-4-2
and the relative humidity is at
least 30 %.
2 kV for power 2 kV for power supply Mains power quality is that of a
supply lines lines typical commercial and/or
Electrical fast
hospital environment
transient pulse 1 kV for
1 kV for input/output
IEC 61000-4-4 input/output lines
lines
Surge 1 kV Line(s) to 1kV Line(s) to Line(s) Mains power quality is that of a
Line(s) typical commercial and/or
IEC 61000-4-5 2 kV Line(s) to earth hospital environment.
2 kV Line(s) to earth
Voltage dips, short Mains power quality should be
interruptions and that of a typical commercial or
voltage variations hospital environment. If the
on power supply operator of the OEC One Mobile
input lines C-arm X-ray Product requires
IEC 61000-4-11 0% UT 0% UT continued operation during
power mains interruptions, it is
(250/300 cycle) recommended that the OEC
One Mobile C-arm X-ray
Product should be powered
from an uninterruptible power
supply or a battery.
Power frequency 30 A/m 30 A/m Power frequency magnetic
magnetic field fields are at levels
(50/60Hz) characteristic of a typical
location in a typical commercial
IEC 61000-4-8
and/or hospital environment.
(50Hz or 60Hz)
NOTE：UT is the a.c. mains voltage prior to application of the test level.
Page 1-25

The OEC One Mobile C-arm X-Ray Product is intended to use in the specified electromagnetic environment. The
purchaser or user of the OEC One Mobile C-arm X-Ray Product should assure that it is used in an electromag-
netic environment as described below:
IEC 60601 Compliance Electromagnetic Environment
Level
Test Level
Portable and mobile RF communications
equipment are used no closer to any part of
the OEC One Mobile C-arm X-Ray Product,
including cables, than the recommended
separation distance calculated from the
equation appropriate for the frequency of the
transmitter.
Recommended separation distance
Conducted RF 3Vrms, 6Vrms at 3Vrms, 6Vrms at 3,5
ISM band 150kHz ISM band 150kHz d =[ ] P 150 kHz to 80 MHz
IEC 61000-4-6 3
to 80MHz to 80MHz
3,5
d = [ ] P 80 MHz to 800 MHz
3
Radiated RF 3V/m 80MHz to 3V/m 80MHz to
7
2.5GHz (Ed3.0) 2.5GHz (Ed3.0) d =[ ] P 800 MHz to 2.5 GHz
IEC 61000-4-3 3
The formulas are applicable for Ed3.0 only.
3V/m 80MHz to 3V/m 80MHz to Note: P is the power rating of the transmitter
2.7GHz, 28V/m 2.7GHz, 28V/m in watts (W) according to the transmitter
(Ed4.0) (Ed4.0) manufacturer and d is the recommended
separation distance in meters (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site
survey a, are less than the compliance level in
each frequency range b.
Interference may occur in the vicinity of
equipment marked with the following symbol:
a: Field strengths from fixed transmitters, such as base stations for cellular telephones and land mobile radios, amateur
radio, AM and FM radio broadcast, and TV broadcast cannot be estimated accurately. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be performed. If the measured field
strength exceeds the RF compliance level above, observe the OEC One Mobile C-Arm X-Ray Product to verify normal
operation in each use location. If abnormal performance is observed, additional measures may be necessary, such as
re-orienting or relocating the [EQUIPMENT and/or SYSTEM].
b: Over the frequency range 150 kHz to 80 MHz, field strengths are less than 3 V/m.
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
NOTE 3: These are guidelines. Actual conditions may vary.
Page 1-26
The Recommended Separation Distances are listed in the next table.

It is applicable for Ed3.0 only.
Recommended Separation Distances for Portable and Mobile RF Communications Equipment

and the OEC One system
The OEC One Mobile C-arm X-ray Product is intended to use in the electromagnetic environment where the
RF interference is controlled. According to the power rating of the communication equipment, the
purchaser or operator of the OEC One Mobile C-arm X-ray Product can prevent the Electromagnetic
interference by the recommended separation distance below:
Separation Distance/m
Rated Power of
Transmitter/W
150KHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
3,5 3,5 7
d =[ ] P d =[ ] P d =[ ] P
3 3 3
0.01 0.12 0.12 0.23
0.38 0.38 0.73

0.1
1.2 1.2 2.3

1
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a power not listed above, the Separation Distance can be estimated using the
equation in the corresponding column, where P is the power rating of the transmitter in watts (W) according
to the transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
NOTE 3: These are guidelines. Actual conditions may vary.
Page 1-27

The OEC One Mobile C-arm X-ray Product is intended to use in the electromagnetic environment specified below. The
purchaser or operator of the OEC One Mobile C-arm X-ray Product should assure that it is used in an electromagnetic
environment as described below:
Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment
Test Maximum I MMUNITY
Band a) Service a) Modulation b) Distance
frequency power TEST LEVEL
(MHz) (MHz) (W) (m) (V/m)
Pulse
b)
385 380 –390 TETRA 400 modulation 1,8 0,3 27
18 Hz
FM c)
GMRS 460, 5 kHz deviation
450 430 – 470 2 0,3 28
FRS 460
1 kHz sine
710
Pulse
LTE Band 13, modulation b)
745 704 – 787 0,2 0,3 9
17
217 Hz
780
810 GSM 800/900,

TETRA 800, Pulse
870 800 – 960 iDEN 820, modulation b) 2 0,3 28
CDMA 850,
18 Hz
930 LTE Band 5
1 720 GSM 1800;

CDMA 1900; Pulse
1 845 1 700 – GSM 1900; modulation b) 2 0,3 28
1 990 DECT;
LTE Band 1, 3, 217 Hz
1 970 4, 25; UMTS
Bluetooth,
WLAN, Pulse
2 400 – modulation b)
2 450 802.11 b/g/n, 2 0,3 28
2 570
RFID 2450,
217 Hz
LTE Band 7
5 240
Pulse
5 100 – WLAN 802.11 modulation b)
5 500 0,2 0,3 9
5 800 a/n
217 Hz
5 785
NOTE: If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and the
ME EQUIPMENT or ME SYSTEM may be reduced to 1 m. The 1 m test distance is permitted by IEC 61000-4-3.
a) For some services, only the uplink frequencies are included.

b) The carrier shall be modulated using a 50 % duty cycle square wave signal.
c) As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because while it does not represent
actual modulation, it would be worst case.
Page 1-28
It is applicable for Ed4.0 only.

Portable RF communications equipment (including peripherals such as antenna cables and
WARNING external antennas) should be used no closer than 30 cm (12 inches) to any part of this
equipment, including cables specified by the manufacturer. Otherwise, degradation of the
performance of this equipment could result.
Use Recommendations
This product complies with IEC 60601-1-2 EMC standard for medical devices and with radio frequency
emission requirements per CISPR11 Group1 Class A standard limits. The system is intended for use in
hospitals.
The EMISSIONS characteristics of this equipment make it suitable for use in industrial areas
NOTE and hospitals (CISPR 11 class A). If it is used in a residential environment (for which CISPR 11
class B is normally required) this equipment might not offer adequate protection to
radio-frequency communication services. The user might need to take mitigation measures,
such as relocating or re-orienting the equipment.
Adhering to the distance separation recommendation table, between 150 kHz and 2.5 GHz, will reduce
disturbances recorded at the image level but may not eliminate all disturbances.
However, when installed and operated as specified herein, the system will maintain its essential
performance.
For example, a 1W mobile phone (800 MHz to 2.5 GHz carrier frequency) shall be put 2.3 meters apart from
the system (in order to avoid image interference risks).
The use of accessories, transducers, and cables other than those specified may result in degraded
ELECTROMAGNETIC COMPATIBILITY of the system.
Page 1-29
1.11. Equipment Malfunction

If either the hospital or equipment circuit breakers trip, an equipment malfunction may be indicated. Do not
attempt to operate the equipment until a GE Healthcare authorized service engineer has checked it.
If any of the equipment controls fail to respond as indicated in this manual, you should:
1. Press the emergency switch, then press the power switch, and unplug the power cord from the AC
receptacle.
2. Notify the GE Healthcare authorized service engineer.
3. Do not operate the equipment until the service technician advises that it is operating properly.
Establish an operation room emergency procudure to ensure patient and operator safety in
WARNING the event of a system failure.
CAUTION Please do not position the system in any place where it is difficult to unplug the power cord.
1.12. Mains Isolation

Unplug the power cord to isolate system circuits electrically from the supply mains on all poles
simultaneously.
1.13. External Devices

To ensure patient safety, only connect the external equipment which has been approved by GE Healthcare.
All equipment attached to external interface connections must meet the requirements for IEC 60601-1
when operated within the patient environment. When used outside of the patient environment, each
externally connected device must comply with the relevant IEC/ISO requirements for that device. In any
case, the combination of all externally connected equipment shall not cause the leakage current of any
device used within the patient environment to exceed the limits stated in IEC 60601-1.
Cover the connector when it is not in use to avoid being touched unintentionally. Only
WARNING connect the medical devices that comply with IEC 60601 standards. Connecting a
non-compliant device could cause injury to the operator, the patient or the equipment.
Page 1-30
1.14. Patient Environment

1.14.1. Within the United States
Within the US the Patient Environment is defined by NFPA 99. In areas in which patients are normally cared
for, the patient environment is the space with surfaces likely to be contacted by the patient or an attendant
who can touch the patient.
This encloses a space within the room 6 ft. beyond the perimeter of the bed (examination table, dental
chair, treatment booth, etc.) in its intended location, and extending vertically 7.5 ft. above the floor.
Patient Environment Inside the United States
1.14.2. Outside the United States

Outside the US the patient environment is defined by IEC 60601-1. In areas in which patients are normally
cared for, the patient environment is the space with surfaces likely to be contacted by the patient or an
attendant who can touch the patient.
This encloses a space within the room 1.5 m beyond the perimeter of the couch (examination table, dental
chair, treatment booth, etc.) in its intended location, and extending vertically 2.5 m above the floor.
Patient Environment Outside the United States
Please consider the dose attenuation caused by the couch or other materials located in the
NOTE
X-RAY BEAM (examination table, dental chair, treatment booth, etc.) during the operation.
Page 1-31
Chapter 2. System Overview
System Overview
2.1. General Description

The OEC One is a compact mobile fluoroscopic C-arm imaging system which physically consists of a mobile
stand with an articulating arm attached to it to support a 27’’ image display monitor and a 10.1” TechView
tablet, and a “C” shaped apparatus that has the X-ray Source assembly on the top of the C-Arm and an
image intensifier at the opposite end.
WARNING Only properly trained people can operate this equipment.
OEC One Mobile C-arm X-ray Product includes:

• Mobile C-arm, X-ray generator, collimator, image intensifier, display device, and footswitch.
Options and accessories:
Wireless module
30cm skin spacer
Removable grid
Removable filter
Video distributor
Laser aimer on the tube
Laser aimer on the image intensifier
Film cassette holder
Nominal Length of External Cables:

Power cable: ~7.5m
Footswitch cable: ~5m or ~10m
For more information, please refer to Technical Reference Chapter.
This manual is provided for operators using the OEC One product for uses described in the Indications for
use. It has been written to describe the use of the system in its most complete configuration. If any of the
options described in this manual are not included on your system, skip the corresponding chapter or
section. Contact GE OEC Customer Service for the options available in your market.
Page 2-2
2.2. System Components Overview

1. Image intensifier & camera 21. C-arm handle
2. Grid 22. Front universal wheel
3. Monoblock handle 23. Rear steering wheel
4. Monoblock & collimator 24. Spring arm lock
5. Exposure indicator 25. Spring arm
6. Monitor 26. TechView tablet (control panel)
7. Monitor handle 27. Extension arm
8. Extension arm handle 28. Extension arm brake handle
9. Cross arm brake handle 29. Wig-wag brake handle
10. Lateral brake handle 30. Driving handle
11. Emergency switch 31. Steering handle
12. Up & down button 32. Power on/off button
13. Orbital brake handle 33. Power cord & footswitch holder
14. Brake pedal 34. Hand switch & holder
15. Key switch 35. NTSC/PAL composite video output connector
16. Power indicator 36. DVI-D digital video output
17. Power cord 37. Ethernet port
18. Incoming circuit breaker 38. Room interface
19. Footswitch socket 39. USB port
20. Image intensifier handle 40. Wireless power switch
Page 2-3
System Overview
Page 2-4
Page 2-5
Chapter 3. Mechanical Positioning &
System Start Up
Mechanical Positioning & System Start Up
3.1. Overview
This chapter describes:
• Transport the system

• Monitor adjustment
• TechView tablet (Control panel) adjustment
• Brake pedal positioning
• Positioning the C-arm movements
• Power on/off the system
3.2. Transport the System

Be familiar with the location and mechanical operation of all controls before transporting the system.
Neglecting the precautions during moving could cause the system to lose control and may
CAUTION cause injury to the operator and other people.
Before transporting the system, please make sure the brake handles: the C-arm orbital
WARNING rotation brake, the lateral rotation brake, the wig-wag brakes, and the horizontal cross arm
brake are locked. Otherwise, equipment damage or personal injury may result. If any brakes
are not firmly locked, don’t transport the system and contact GE Healthcare service engineer.
Before moving the system, please make sure the system is in transportation position.
WARNING Otherwise, equipment damage or personal injury may result.
Cords and cables connected to the system can become trip and/or snag hazards in the
CAUTION working area. Personnel working around the system should be aware of all cords and cables
whenever they move around the system or the system is moved.
CAUTION Pay attention and keep feet away from the chassis whenever moving the system.
Be aware:
• Check and make sure there are no obstacles in the way

• Move the system slowly
1. Press and hold the power on/off button about 2 seconds to switch the system off if the system is
powered on.
2. Unplug the power cord from power source and secure the power cable around the power cable and
footswitch holder.
3. Lock the C arm assemblies as the transportation position as indicated below:
Page 3-2
When the system is positioned on an incline with the brake handle released, the C-arm might
WARNING be unstable. Please be sure to put the system in locked position.
4. Coil the footswitch cable around the footswitch, and secure the footswitch on the holder.
5. Unlock the brake pedal on the system.
6. Guide the system to its destination using the driving handle and steering handle.
NOTE
When moving the system, refer to the chapter of brake pedal positioning.
Page3-3
Do not move the C-arm over inclines greater than 10°. Do not move the C-arm up or down
WARNING stairs or steps. Do not lock the C-arm in place on an incline greater than 5°.
Transport the system at normal speed. Get across ramps and thresholds as slow as possible.
7. When reaching the destination, place the brake pedal in the locked position.
3.3. Monitor Adjustment

The Monitor can be placed to the proper position for best viewing by articulating arm.
Hold the monitor handles to adjust the tilt degree until it moves to the desired position. Monitor tilt
adjustment range: 5° up/25° down.
• Hold the monitor handles to adjust the height. Adjustment range: up/down 20 cm.
Page 3-4
• The extension arm rotation range is: 210°

• The spring arm rotation range is: 180°
• The monitor swivel range is: 180°
Please lock the monitor by the brake handle. Take attention not to let monitor crack with C
WARNING
Arm, otherwise this may cause injury to the operator, the patient or damage the equipment.
Page3-5
3.4. TechView Tablet (Control Panel)

Adjustment
Hold the TechView tablet (control panel) to adjust the tilt degree until it moves to the desired position.
Adjustment degree: 30° up/10° down.
TechView tablet (control panel) swivel range: 270°.
Page 3-6
3.5. Brake Pedal Positioning

Press the brake pedal to the brake position to lock the rear steering wheel.
Press the brake to free position to release the rear steering wheel. The pedals are located on each side of the
system.
Front universal wheel Rear steering wheel Free position
Front universal wheel Rear steering wheel Brake position
Page3-7
3.6. Positioning C-arm Movements

The C-arm is capable of performing linear and rotational motions that will allow the user to position the X-ray
imaging components at various angles and distances with respect to the patient.
The arm provides flexibility in positioning the system for each procedure. It makes both vertical and
horizontal movement easy.
When positioning C-arm, avoid contact with patients and other objects.
3.6.1. C-arm Orbital Rotation

The system provides 120° of orbital rotation (90° under scan and 30° over scan). The side of the C-arm is
marked with a scale to aid in positioning.
Orbital brake
handle
To lock or unlock the orbital rotation brake, turn either of the brake handles located on both sides of the
C-arm. The operation position is indicated by a label.
Do not place fingers or allow clothing between these parts when positioning the C-arm.
WARNING
Page 3-8
3.6.2. Lateral Rotation
Lateral brake handle
During rotation, there are accessible moving parts, keep hands/fingers away from the moving
WARNING parts or the location where the moving parts may collide.
The C-arm can provide ±205°of lateral rotation on the cross arm axis.
When accessories such as the laser aimer or film cassette are attached to the C-arm,
CAUTION releasing the orbital or lateral rotation brake could cause the C-arm to move. Make sure to
hold the C-arm to control its movement whenever a brake is released.
Page3-9
Mechanical Positioning
3.6.3. Wig-wag
Wig-wag brake handle
The movement range of the Wig-wag is 25°.

Release the Wig-wag brake by placing the brake handle in the position indicated by the “unlock” label to
enable the Wig-wag movement of the C-arm.
Lock the Wig-wag brake by placing the brake handle in the position indicated by the “lock” label to lock the
Wig-wag movement of the C-arm.
CAUTION Pinch points exist under the Wig-wag brake handle.
Page 3-10
3.6.4. Vertical Column Operation
The vertical column motor is actuated by pressing the up and down vertical column switches located on top
cover of the mainframe. Use the vertical column to elevate or lower the C-arm.
Press or to lift and lower the C-arm, the upward movement continues until the switch is released or
the movement reaches its limits.
When C-arm can’t be driven down by only pressing down switch, please release the switch, make sure there
are no obstacles. Press the switch one more time, it will lower C-arm to the lowest position.
Please make sure C-arm will not be blocked by any other objects during the vertical
WARNING movement. If there are any obstacles, system may sound two beeps and stop movement.
Please check and clear the obstacle. Then you can continue to raise or lower the C-arm.
If any failure occurs, please contact GE Healthcare authorized service engineer.
When positioning the vertical column, observe the moving assemblies to ensure the safety of
patients and hospital personnel.
Page 3-11
3.6.5. Horizontal Cross Arm

The horizontal cross arm extends a maximum of 20cm.
To position the cross arm:
1. Release the cross arm brake by placing the brake handle in the position identified by the "unlock"
label.
2. Push or pull the cross arm to the desired position. Use the centimeter scale located on the cross arm
as an aid in positioning.
3. Lock the cross arm brake by placing the brake handle in the position identified by the "lock" label.
Cross arm brake handle
Page 3-12
3.6.6. C-arm Steering Handle

Use the steering handle to turn the rear wheels ±90° to the right or left. Use this feature to position the C-arm
during clinical applications or to negotiate sharp turns during transport. The rear wheels turn as
approximately the same angle as the right steering handle.
To avoid losing the control of the Mobile C-arm, always reduce transport speed before moving
CAUTION
the steering handle out of 0° position.
Steering handle
3.7. Start Up
3.7.1. Power On
At initial setup or when removing from storage, stabilize for 24 hours at ambient temperature
WARNING and humidity before applying power. Failure to observe this warning will result in damage to
equipment.
Remove USB storage devices from USB connector before booting，otherwise system booting
CAUTION
may fail.
1. Plug the system power plug into a properly rated AC receptacle to connect the system. For more
information about power requirements, please refer to Chapter 15.
The system provides batteries to protect data loss. If the power is lost during operation, the battery will
supply power to computer and the TechView tablet (control panel) until the system shuts down automatically.
In this case, operator needs to restart the system after power is restored to proceed.
Page 3-13
If the system loses power due to loose plug connection, operator needs to reconnect the power plug before
the system turns off automatically. Then, the system can recover to normal working condition. During this
time, the monitor will be turned off, but the TechView tablet (control panel) will remain on.
NOTE Always position the system so that the power plug is accessible and can be easily unplugged
in case of an emergency.
The data may be lost when the power of the battery is low.
WARNING
Data may be lost due to the system’s power accidently lost.
Do not disconnect, repair or replace battery without permission. Only a GE Healthcare

WARNING authorized service engineer can perform repair and replacement. The life cycle of the battery
is about 3 years in normal use. It may be different in different conditions. Please press the
emergency switch to disconnect power if system is not likely to be used for long time.
To use the system for the first time, it is recommended to boot the system for continuous 20
NOTE hours to ensure that the battery is fully charged, otherwise if the system power down
accidentally, there is risk that the system will not safely power off; during the normal work,
when the system powers down accidentally, the battery plays a protective role to ensure the
system safely powers off, and it is recommended to power the system 8 hours in advance to
ensure that the battery is fully charged the next time; an additional charge of the battery is not
necessary when the system does not abnormally power off.
Use drapes, if necessary, to protect equipment when performing procedures. Draping the
NOTE X-Ray tube housing will inhibit air flow resulting in cooling inefficiencies. This may result in the
housing reaching its rated heat capacity sooner. When the housing reaches its maximum
rated heat capacity, X-Rays will be discontinued until the housing has cooled.
2. Connect the footswitch to the footswitch socket.

3. Key Switch is to enable/disable X-ray. There are 3 positions of the key switch:
On position, C-arm is fully operational.
X-ray Off position, only X-ray is disabled, and the vertical column movement is enabled.
Off position, X-ray and the vertical column movement are disabled, but the C-arm remains powered.
It is recommended to turn the key switch to Off position and safe keep it at all times, except
NOTE when a procedure is in progress, to prevent the possibility of radiation being emitted through
the inadvertent actuation of an X-ray switch.
Page 3-14
4. Press the system power on/off button. The light within the button will start blinking until start up
sequence is complete. Then the light will remain on to indicate the power is turned on. The system will
begin the power up sequence. The boot up time is about 2 minutes.
5. The system is ready for operation when the login screen or Exam Management screen is displayed on the
monitor. The field size is in normal state by default. The auto fluoroscopy mode is selected.
The system can not be powered off until start up sequence completes.
NOTE
If the system unexpectedly become unresponsive or lock-up, restart the system to return it to
normal operating condition.
CAUTION If a problem is encountered during power on, an error message may be displayed on the
monitor and restart will be required. If restart system and failure remains, call the GE
Healthcare authorized service engineer for service.
Data loss can occur if the system startup sequence is interrupted. Do not unplug the power
cord until system startup is complete.
Draping the X-ray tube housing will inhibit air flow resulting in cooling inefficiencies. This may
NOTE
result in the housing reaching its rated heat capacity sooner.
3.7.2. Power Off

Perform the following steps to turn the system off:
1. Press and hold the power on/off button, then the power button light will start flashing
and the system will turn off.
NOTE
If pressing the power switch fails to turn the system off, unplug the power cord, and wait for
the system to execute the shutdown process.
2. After turning off the system, the power button light will be turned off. Then, remove
all power, and unplug the system power cord from the AC receptacle.
CAUTION After turning off the system, please wait for at least 1 minute before powering the system back
on. This can help to prevent operational problems.
Remove all power from the system before moving the system, or if a problem occurs which
NOTE
prevents normal operation.
All power should also be removed when periodic maintenance and cleaning is performed.
During powering off, the power shall not be cut off automatically until the system software
closes.
During powering off, the system will ignore power on command until shutdown is finished.
Page 3-15
3.7.3. Emergency Switch

The emergency switch is located at front of the driving handle. When an emergency occurs, press the switch
to stop vertical column mechanical movement, disable X-rays, and disconnect the batteries at the same time.
If the emergency switch is pressed, vertical column operation will cease and X-rays will be disabled. Rotate
the Emergency Switch in the direction of the arrow indication to release it and continue to use the system.
Should the system unexpectedly become unresponsive or locks-up, restart the system to return it to normal
operating condition. If the system fails to respond or continues to lockup, please contact GE Healthcare
authorized service engineer.
Do not use emergency switch when the system is in normal use, it is just to be used when in
WARNING any emergency case such as in fire, or electric shock. This will also disable the backup power
immediately which may cause the loss of data.
Page 3-16
System Control
System Control
4.1. Overview
This chapter describes how to use the system controls for imaging and post-processing. Before using the
system, you should become familiar with the controls located on the following components:
• Monitor
• TechView tablet (control panel)
When using the system to produce X-rays, you should also understand how the X-ray switches operate.
These X-ray switches are described in this chapter:
• Footswitch
• Hand switch
Do not touch tube housing or let it touch anyone during operation due to the potentially high
CAUTION
temperature generated by the tube.
This equipment produces scatter radiation. Ensure proper safety practices during
WARNING operation.
Lack of backup battery capacity may cause loss of data. Then the system is not
WARNING recommended for use during surgery.
Page 4-2
4.2. Monitor Controls

The monitor provides a touchscreen for interacting with the system. Using the touchscreen enables the user
to:
• Enter and view patient information
• View and process images
• Annotate images
• Measure images
• Setup system
To select a touchscreen button, touch it and quickly remove your finger from the touchscreen.
Select the button below the user interface to display the related functions. Some of the functions are
available based on which configuration you have purchased.
13 23 14 15 16 17 18 19 20 24 21 22
9 10 11 12 1 2 3 4 5 6 7 8
Page 4-3
System Control
1. Exam Management
Press the button to display the Exam Management screen, which allows operator to enter patient
information.
2. Image Directory
Press the button to display the Image Directory screen, which allows operator to review, print, and
archive the stored images and dose information.
3. Annotation
Press the button to display the Annotation screen, which allows operator to place markers, add
comments and crop images.
4. Measurement
Press the button to display the Measurement screen, which allows operator to measure images.
5. Zoom
Press the button to activate the Zoom function.

6. Query and Retrieve
Press the button to display the Query & Retrieve screen, which allows operator to query remote server
and retrieve images from Query & Retrieve server.
7. Setup
Press the button to display the Setup screen, which allows operator to configure system setup options.
8. Image processing TechView tablet (control panel)
Press the button to display the Image processing TechView tablet (control panel) which allows operator
to adjust images’ orientation, contrast, brightness, smart metal, edge enhance, and noise filter.
9. Save
Press the button to save the monitor left area images on the system disk.
10. Swap
Press the button to exchange images between the left area and right area of the monitor.
11. Logout
Press the button to allow operator to log out the system.

12. Screen Saver
Press the button to let the screen enter screen saver.

13. Exposure mode status bar
When the system is operating, the current exposure mode, and pulsed mode will display on the monitor.
Page 4-4
14. Dose information

Display the current exam’s dose information.
15. Tube temperature
Check and monitor the tube temperature.
16. Emergency login
When the system is in quick mode, “Emergency Login” will show.
17. X-ray off indicator
When the key switch is in X-ray off or Off position, the tube is overheated, or in any other X-ray off case, the
indicator will show.
18. No TechView tablet (control panel)
When the communication between the TechView tablet (control panel) and the system is lost, the symbol will
show.
19. Battery status indicator
When the battery is low ( ), battery is not installed ( ), or any other issues which relate to battery
malfunction ( ), the status indicator will show.
20. Removable filter Installation Indicator
The status will show whether the removable filter is installed ( ), or not installed ( ).
21. Hard disk storage space
Displays the number of images which can be saved in the hard disk.
22. Time
Displays the current system time.
23. Monitor left area
The left area displays the current image.
24. Monitor right area
The right area is used for image comparison.
Page 4-5
System Control
4.3. TechView Tablet (Control Panel)

The TechView tablet (control panel) allows operator to control the generation, display of images and adjust
the parameters of fluoroscopy and radiographic film. Choosing each panel (HOME, IMAGE, and X-RAY) allows
operator to use different functions:
• Adjust image orientation
• Mini ID panel
• Adjust image intensifier field size
• Control collimator
• Control generator
• Adjust contrasts/brightness, smart metal, noise filter, edge enhance, negate
The TechView tablet (control panel)’s images are for reference only, and are not intended for
NOTE
diagnostic purposes.
6 4
3 1 2
1. Save
Press the button to save the monitor’s left area images on the system disk
2. Swap
Press the button to exchange images between the monitor left area and monitor right area.
Page 4-6
3. Exposure mode status bar

When the system is in operating, the current exposure mode and pulsed mode will display on the TechView
tablet (control panel) .
4. Mini ID panel
Slide on the mini ID panel to review images. Select one previewed image to display it on the TechView tablet
(control panel) and monitor left area.
5. TechView tablet (control panel) view
The TechView tablet (control panel) view will copy the image from the monitor left area.
6. X-ray disable indicator
When the key switch is in X-ray off or Off position, the tube is overheated, or in any other X-ray disable case,
the indicator will show.
4.3.1. HOME
Exposure Parameter Bar
Page 4-7
System Control
In HOME panel, the exposure parameter bar will display kVp, mA, Fluoro Time.
In manual mode, press button in X-RAY panel, then the exposure parameter bar will display .
Continued use without cooling may damage the X-ray tube. A warning message will display
on the monitor if the tube temperature is too high. Although fluoroscopy is not prevented, you
should wait for the tube to cool before making another exposure.
Image Orientation
Use buttons below to rotate or reverse the image displayed on the monitor left area. Image rotation and
image reversal are useful for displaying the image in any orientation that operator desires.
Image rotation and image reversal are not available to be used on the image of monitor right area, and when
image annotation or image measurement has been applied.
Image Rotation
In HOME panel, press/drag the left button to rotate the image counter-clockwise, and press/drag the right
button to rotate the image clockwise. The rotation degree will display on the lower left corner of the TechView
tablet (control panel) and the monitor.
Image Reversal
In HOME panel, press the buttons to change the orientation of the image displayed on the monitor’s left area.
Press the left button to reverse the image from left to right, and press the right button to invert the image
from top to bottom. The reversal direction will display on the lower left corner of the TechView tablet (control
panel) and the monitor.
Image Intensifier Field Size
Field Size
In HOME panel, press the button to select field size: 9“/6“/4.5”.
X-ray field will be adjusted automatically to match the selected Field Size. In each field size, operator is not
permitted to increase the size beyond the currently selected field size limitation, but can close the collimator
manually to reduce the X-ray field.
Collimator Control
The X-ray beam may be collimated by using the iris collimator or the shutter collimator. Press the button until
the shutter or iris is in the desired position.
Shutter Collimator Rotation

In HOME panel, press the left button to rotate the shutter collimator counter-clockwise, and press the right
button to rotate the shutter collimator clockwise.
Shutter Collimator Open/Close

In HOME panel, press the buttons to open, or close the shutter collimator. Press the bottom button to close
the shutters, and press the top button to open the shutters.
Page 4-8
Iris Collimator Open/Close

In HOME panel, press the buttons to open or close the collimator iris. Press the bottom button to close the iris
or the top button to open the iris.
When the system is transferred to film mode, Iris opens fully. And the parameters set in the fluoroscopy mode
are memorized. When return to fluoroscopy mode, it can be restored until a reset is made.
Proper use of the iris can decrease the X-ray radiation to the patient and improve image
quality.
Low Dose
In HOME panel, press the button to select the Low Dose mode. The button’s light will illuminate to indicate the
mode is selected. If possible, please select Low Dose mode to reduce the exposure dose rate to the patient.
Noise Filter
In HOME panel, press the button to select noise filter levels. The default level is “2”, noise filter levels are
“0”/”1”/”2”/”3”.
Noise filter function provides image noise reduction. Higher levels of recursive filtering produce
smoother (or less noisy) image, but cause more lag when imaging moving objects or anatomy.
Digital Spot Mode

In HOME panel, press the button to activate Digital Spot mode, and the button’s light will illuminate. At the
same time, the right side of footswitch/hand switch will change to Digital Spot mode. Press the button one
more time to turn off the button’s light, and the HLF mode will reactivate.
High Level Fluoro mode and Digital Spot mode are both High Dose Fluoro imaging which can
subject the patient and those working around the X-ray field to a significantly larger dose of
radiation than they would receive during normal fluoro operation. To minimize X-ray
exposure hazards, use High Level Fluoro imaging with discretion.
Pulse
In HOME panel, press the button to enable pulsed imaging, the default rate is “Continuous”, pulse rates are
1Pulse/s, 2Pulse/s, 4Pulse/s, 8Pulse/s.
Using a pulsed fluoro mode can significantly reduce the dose received by the patient.
However, image quality may be degraded in pulsed fluoro mode.
Alarm Reset
The system counts the amount of time that X-rays are generated when an X-ray switch is pressed. The
amount of accumulated fluoroscopy time will be indicated on the TechView tablet (control panel)’s exposure
parameter bar.
If pulsed imaging is enabled, the amount of time accumulated depends on the length of time an X-ray switch
is pressed and the length of the pulses and the number of pulses per second.
Page 4-9
System Control
In HOME panel, press alarm reset button to turn off the alarm.
When system accumulated fluoroscopy time is over 4’30’’, the alarm will sound continuous beeps and
illuminate the button light. Press the alarm reset button to reset the time, and turn off the button light.
When system accumulated fluoroscopy time at 9’, the system will sound continuous beeps. When this time
reaches 9’30’’, X-rays will be terminated automatically.
Repetitious prolonged exposure could increase radiation and probability of harm to the
patient and operator.
4.3.2. IMAGE
Image Processing
Noise Filter
In IMAGE panel, press +/- to adjust noise filter level.
Recursive filter function provides image noise reduction. Higher levels of recursive filtering produce
Page 4-10
smoother (or less noisy) images, but causes more lag when imaging moving objects or anatomy.
Contrast
In IMAGE panel, press +/- to adjust contrast level. The contrast level will display on the right corner of the left
area of both the TechView tablet (control panel) and the monitor.
Brightness
In IMAGE panel, press +/- to adjust brightness level. The brightness level will display on the right corner of the
left area of both the TechView tablet (control panel) and the monitor.
Auto Brightness/Contrast
In IMAGE panel, press the auto button to automatically adjust the brightness and contrast level. The button’s
light will illuminate. Disable auto mode by pressing the button one more time. The auto mode will display on
the right corner of the left area of both the TechView tablet (control panel) and the monitor.
Brightness/Contrast can be applied to static and dynamic images. This function can be applied
to live and post-processed images.
Smart Metal
In IMAGE panel, press +/- to adjust the appearance of metal in the image. It could provide optimum image
quality even when metal is introduced to the field. The current smart metal level is shown in a numeric value
displayed on the right corner of the left area of both the TechView tablet (control panel) and the monitor.
When there is no metal in the field, please make the smart metal value as 0 to disable it.
Page 4-11
System Control
Auto Smart Metal

In IMAGE panel, press the auto button to automatically adjust the smart metal level. The button’s light will
illuminate. Disable auto mode by pressing the button one more time.
Smart Metal can be applied to static and dynamic images. This function can be applied to live
and post-processed images.
Edge Enhancement
In IMAGE panel, press +/- to adjust the edge enhancement level in images. The edge enhancement level will
display on the right corner of the left area of both the TechView tablet (control panel) and the monitor.
Edge Enhancement can be applied to static and dynamic images. This function can be applied
to live and post-processed images.
Negate
In IMAGE panel, press the button to activate negate function, and the button’s light will illuminate.
Negate is applied to the current image on the monitor left area and all subsequent images produced until
negate is disabled. Disable negate by pressing the negate button again.
Negate can be applied to static and dynamic images.
Page 4-12
4.3.3. X-RAY
kVp Adjustment
In X-RAY panel, press / to adjust kVp.
mA Adjustment
In X-RAY panel, press / to adjust mA.
Manual mode can be selected directly by pressing kVp or mA adjustment button during auto
mode.
Page 4-13
System Control
Auto exposure parameter

In X-RAY panel, press the button to automatically adjust the kVp and mA. The button’s light will illuminate.
Disable auto mode by pressing the button one more time. The auto mode will display on the right corner of
the left area of both the TechView tablet (control panel) and the monitor.
Under the auto exposure parameter mode, system will activate the auto brightness/contrast mode. When
disable the auto exposure parameter mode, the auto brightness/contrast mode will also disable. Also, under
the auto exposure parameter mode, the auto smart metal mode will not be activated. The auto exposure
parameter mode will display on the TechView tablet (control panel)’s exposure parameter bar and right
corner of the monitor left area .
Film
In X-RAY panel, press the button to enable film operation. The button’s light will illuminate when film mode is
enabled. In this mode, kVp and mAs values can be adjusted manually. For more information, please refer to
Chapter 10.
High Level exposure

Disable/Enable HLF mode/Digital Spot mode. This button only works in Australia.
Page 4-14
4.4. Footswitch and Hand Switch

The X-ray foot/hand switch offer maximum flexibility to control X-rays generation. Switches may be used to
generate X-rays or save images.
Before exposure, please check and confirm the mode which is selected to avoid unexpected
WARNING X-ray exposure.
Taking very rapid and short exposures repeatedly over an extended period may cause errors
CAUTION
to occur. Avoid continuous tapping on the X-ray switch over long period of time.
Footswitch
Press the left pedal labeled to produce normal fluoroscopic images. Press the right pedal labeled
to produce high level fluoro or digital spot images.
Press the save button labeled to save the image displayed on the monitor left area.
When using the save button, use caution to not inadvertently to activate the X-Ray footswitch.
CAUTION
Page 4-15
System Control
Hand switch
Press the left black button labeled to produce normal fluoroscopic images. Press the right yellow button
labeled to produce high level fluoro or digital spot images.
When choosing film mode, press any button to generate radiographic film.
Page 4-16
Chapter 5. Exam Management
Exam Management
Use Exam Management screen to:

• Create a new exam.
• Query scheduled exams.
• Resume performed exams.
• Edit patient information.
Be cautious while the system is in use. Any sudden, intense impact may damage the system
WARNING or result in loss of images and prevent further imaging.
All user interface in this manual is for reference only, the operator needs refer to the actual
NOTE
user interface on product.
5.1. Create a New Exam

The Exam Management screen of a new exam is displayed when a user logs in. The default admin login
password is “123456”.
Select the Exam Management button to display Exam Management screen. Click “New” to create a
new exam.
Enter patient information:
• Use the virtual keyboard to enter patient information. A cursor indicates which field you are in. Use
tab button to move the cursor to the next active field.
Page 5-2
• Fill in all the fields to complete patient information. If user starts a new exam without inputting any
patient information, the current patient name will be assigned by system as ‘’Unnamed xxxxx”.
• Click “Extra Info…” on the Exam Management screen to display the Additional Information screen.
You can add weight, height, referring physician, requested procedure ID, requested procedure
description, protocol description and anatomic regions. Click “OK” to save the additional
information and return to Exam Management screen.
Once you have entered patient information, you may immediately begin taking X-rays for that patient or
select “Exit” or switch to other application. The Exam Management screen will close and display the
desktop. The input information will be automatically saved.
Each time you choose a new exam, resume a performed exam or start a scheduled exam, the system
setting will reset to default parameters. This includes fluoro timer, exposure mode settings, mag mode,
image rotation, Image reversal, brightness/contrast, noise factor, smart metal, negate, edge enhancement,
and exposure parameters.
You can set collimator, mag mode, image rotation and flip/flop to retain last value in System Setup screen.
5.2. Query Scheduled Exams

The scheduled exams feature allows operator to query the exams from worklist server, view locally created
and queried scheduled exams.
Select Scheduled Exams from the Exam Management screen. Scheduled Exams screen is displayed.
The Scheduled Exams screen displays a list of scheduled exams by exam time at descending order. To list
by source, patient name, patient ID, physician, click the related column header. Operator may choose to
display patient ID or accession# in System Setup.
Page 5-3
Exam Management
Select a server from the server dropdown list. Click “Quick Query” to display a list of scheduled exams
queried from the server. Select the “Advanced Query” to set advanced query criteria.
Enter search criteria in the display filter text field to filter exams listed in the Scheduled Exams.
Detailed information of DICOM worklist query, please refer to section DICOM.
Click “Delete” to delete the selected scheduled exam.
Click “OK” to close the Scheduled Exams screen and display the Exam Management screen for the selected
exam. Operator may begin to take exposure for the selected exam.
Click “Cancel” to return to Exam Management screen for original patient.
NOTE Always ensure the correct patient name is displayed on the Exam Management screen.
Page 5-4
5.3. Resume Performed Exams

The Performed Exams screen contains a list of previously performed exams.
Select the Resume Exam button from the Exam Management screen. A Performed Exams screen is
displayed.
The Performed Exams list displays exams by exam time at descending order. To list by status, patient name,
patient ID, physician, click the related column header. Operator may choose to display patient ID or
accession# in System Setup screen.
Enter retrieve criteria in the display filter, a list of exams that meets the retrieve criteria is displayed.
Select the option of exam state: All/ In-Progress/ Completed/ Discontinued, the exams are filtered by the
exam state.
Select the option of MPPS state: All/ Unreported/ Reported, the exams are filtered by the MPPS state.
Select one of In-Progress exams and click “OK” or double click the selected exam to display it. The selected
exam is set as the current exam.
Click “Delete” to delete the selected performed exam.
Click “Report MPPS” to report current selected exams' MPPS State to the configured MPPS server.
Click “Append” to create a new scheduled exam based on the selected exams. Only the completed and
discontinued exams could be appended for further X-ray exposures.
Click “OK” to close the Performed Exams screen and display the Exam Management screen for the selected
exam.
Click “Cancel” to return to Exam Management screen for original patient.
Page 5-5
Exam Management
The completed and discontinued exams cannot be resumed. An information dialog will then
NOTE
pop up.
5.4. Edit Patient Information

Click “Edit” on the Exam Management screen, to edit the patient information.
Click “Exit” to save.
Operator cannot edit patient information under following scenarios:

NOTE
1. Exams queried from server.
2. Image(s) of the exam has/have been sent to server.
3. MPPS has been reported to server.
4. Exam is completed or discontinued.
5. Exam is appended from another exam.
Page 5-6
5.5. Pediatric Patients and Small Patients Use

CAUTION Use special care when imaging patients outside the typical adult size range.
Radiation Exposure Sensitivity

Radiation exposure is a concern in both adults and children. However, children are more sensitive to
radiation than adults and have a longer post-exam life expectancy, so the particular attention should be
paid to the displayed dose values and alarms. Radiation risk is higher in young patients, as they have more
rapidly dividing cells than adults. The younger the patient, the more sensitive they are. Using the same
exposure parameters on a child as used on an adult may result in larger doses to the child. There is no
need for these larger doses to children, and C-arm settings can be adjusted to reduce dose rate
significantly while maintaining diagnostic image quality.
GE strongly suggests reducing radiation dose to As Low As Reasonably Achievable in all patients, especially
pediatric and small patients, whenever it is determined that a fluoroscopic imaging is necessary.
5.5.1. Minimize pediatric and small patient doses

There are several steps that can be taken to reduce the amount of radiation that pediatrics and small
patients receive from C-arm fluoroscopic examinations. Everyone shares the responsibility of minimizing
radiation dose. Use the following suggestions for minimizing unnecessary doses.
Perform only necessary C-arm fluoroscopic examinations
Is C-arm fluoroscopy the most appropriate study? This important communication between the patient's
physician/surgeon is essential in determining the need for the fluoroscopic examination. The indications
and the appropriate technique to be used should be reviewed by the physician/surgeon prior to every
exam including the patient’s number of previous medical X-ray examinations, reasons for the fluoroscopic
procedure, and consideration of other effective lower dose modalities. In all circumstances, the expected
benefits of the fluoroscopic procedure must always exceed the overall risk.
Imaging only the anatomical region indicated
Limit imaging coverage to cover only the anatomical region of the body indicated to avoid unnecessary
exposure.
Obtain only clinically necessary image quality
Limit the highest quality images requiring the highest radiation dose to very specific procedures or
procedure steps. Studies with higher noise may be just as diagnostic and require lower dose.
Other Ideas
Make a kid friendly environment:
Help pediatric patients feel less scared.
• Put pictures of animals on the wall or ceiling.
• Use stuffed animals.
• Play games.
• Depending on the patient age, explain the procedure so they know what to expect when they enter
the operating room. This will aid in patient cooperation and potentially less repeat studies and dose
due to patient motion.
Page 5-7
Exam Management
5.5.2. Imaging Recommendations for Small or Pediatric

Patients
Reduction of radiation dose must be balanced with safe, accurate and effective completion of the
procedure. Not all steps listed below may be possible depending on patient size, technical challenge and
critical nature and type of procedure. The goal through planning is to minimize the dose to the patient while
providing important and necessary medical care while maximizing patient safety.
For pediatric imaging, it is recommended to remove the removable grid and apply the removable filter.
1. Use low dose mode. Low dose mode automatically decreases the calculated ABS normal or manually
entered technique to a new setting that is at ½ the dose rate.
2. Always use the dose warning threshold setup especially for pediatric exams. Use a site dose
management team to help establish appropriate threshold values for patients across age and size
ranges.
3. Skin Spacer is required to be installed, to keep the minimum distance between the patient and X-Ray
focus spot.
4. Adjust acquisition parameters to achieve lowest dose necessary to accomplish procedure.
5. Use laser aimer indicator to aid in proper positioning, this will help avoid extra positioning shots.
6. Keep Image Intensifier as close to patient as possible.
7. Minimize use of magnification mode; use display digital zoom whenever possible.
8. Use last image hold to record information whenever possible instead of exposures.
9. Utilize the DICOM RDSR to establish a site imaging dose review process.
10. Ensure that the equipment is checked regularly by a physicist or designee with appropriate skills.
NOTE Use of low dose mode will affect image quality.
The information and list above has been taken from information on the Alliance for Radiation Safety in
Pediatrics Imaging’s Image Gently website. For more information about pediatric patient safety in
fluoroscopy and other x-ray emitting technologies you can consult:
1. Image Gently at http://www.imagegently.org
2. Image Wisely (Radiation Safety in Adult Medical Imaging) at www.imagewisely.org/
3. Society of Pediatric Radiology (SPR) at http://www.pedrad.org/
4. The American Association of Physicists in Medicine (AAPM) at www.aapm.org/
5. American College of Radiology (ACR) at http://www.acr.org/
6. FDA at
http://www.fda.gov/radiation-emittingproducts/radiationemittingproductsandprocedures/medicalimaging/uc
m298899.htm
7. International Atomic Energy Association’s Radiation Protection of Patients site at http://rpop.iaea.org
Page 5-8
Chapter 6. Imaging
Imaging
6.1. Imaging Mode

This section describes the basic imaging features. Features related with Radiographic(Film) will be
described in Chapter 10.
Establish emergency procedures for handling the patient in case of the loss of imaging or
WARNING other system functions during an exam.
Modes of Operation: Engaging and Disengaging

The imaging modes can be engaged and disengaged by clicking buttons of Mode Setup Screen on the
TechView tablet (control panel).
Mode Setup Screen
You can set imaging mode in HOME panel.
Expousure Mode
During an exam, the configured active mode pair is displayed on the monitor and TechView tablet (control
panel)’s exposure mode status bar.
Page 6-2
The left side of exposure mode status bar is triggered by the left pedal on the footswitch, or left black
button on hand switch. The right side of exposure mode status bar is triggered by the right pedal on
the footswitch, or the right yellow button on hand switch.
Default settings of the right pedal on footswitch and the right yellow button on hand switch are HLF mode.
On HOME panel, when Dig. Spot button is pressed, right pedal on footswitch and right yellow button on
hand switch will be changed to Dig. Spot mode.
6.1.1. Normal Fluoro Imaging

Normal fluoro mode displays live fluoroscopic images on the monitor left area. After images have been
acquired, image attributes such as edge enhancement, contrast and brightness can be modified.
To produce a normal Fluoro image
1. Verify Fluoro is displayed on the exposure mode status bar.
2. Select pulsed X-ray or low dose if desired. On HOME panel, press pulse button to switch between
continuous and pulsed X-rays. Use the low dose button to switch between normal and low dose
imaging.
3. Press the left pedal on footswitch, or left black button on hand switch to take exposure.
6.1.2. High Level Fluoro Imaging

High Level Fluoro (HLF) mode is used to achieve high quality images. High Level Fluoro mode decreases
noise level and improves image quality by increasing fluoroscopic dose rate.
High Level Fluoro imaging can subject the patient and those working around the X-ray
WARNING field to a significantly larger dose of radiation than they would receive during normal fluoro
operation. To minimize X-ray exposure hazards, use High Level Fluoro mode with
discretion.
For each HLF shot, please limit the X-ray time within 20 seconds. Otherwise, the system will
NOTE terminate X-ray automatically. If more HLF time is needed, please release the
footswitch/hand switch and re-press it.
To produce a High Level Fluoro image
1. Verify HLF is displayed on the exposure mode status bar. If Dig. Spot is displayed, press button
back to HLF.
2. If desired pulsed operation is chosen, the pulse rate will be displayed on the button. Use low dose
button to switch between normal and low dose imaging.
3. Press the right pedal on footswitch, or press right the yellow button on hand switch to make High
Level Fluoro exposures.
Page 6-3
Imaging
6.1.3. Digital Spot Imaging

Digital Spot mode creates a short-duration, high mA exposure to produce a single high quality image.
After the image has been acquired, image attributes such as edge enhancement or contrast/brightness
can be modified. Pulsed mode is not available in digital spot mode.
To produce a Digital Spot image
1. On HOME panel, press the Digital Spot button, and the Dig. Spot mode will be displayed on the
exposure mode status bar.
2. Press the left pedal on footswitch, or press the left black button on hand switch to confirm
positioning and obtain appropriate exposure parameters.
3. When the desired image appears on the monitor, release the left pedal on footswitch, or the left black
button on hand switch, and then press and hold the right pedal on footswitch, or the right yellow
button on hand switch to obtain the digital spot image.
4. The system automatically terminates the exposure and saves the Digital Spot image on the hard disk.
5. If the image positioning and exposure parameters have been set, you can press the right pedal on
footswitch, or the right yellow button on hand switch to obtain the digital spot image.
Continue pressing the switch until the system automatically terminates the exposure. If
NOTE
operator releases the X-ray switch early, the exposure will prematurely terminate with a
beep sound.
If the digital spot mode is misused for real-time imaging, the image display delay may be
longer than the delay seen in radioscopy.
6.1.4. Pulsed Fluoro Imaging

This section describes how to switch between continuous and pulsed imaging.
Pulsed mode generates a preset number of X-ray pulses each second while the X-ray switch is pressed.
Pulsed X-rays can be used to reduce total radiation.
To produce a Pulsed Fluoro image
1. In HOME panel, press the pulse button to select pulse rate. The default is “Continuous”.
2. Press either pedal on the footswitch or either button on the hand switch to make Pulsed Fluoro
exposures. (If Digital Sport mode is active, the right pedal on the footswitch or the right button on the
hand switch still produce Digital Spot exposure, not Pulsed Fluoro exposure.)
3. To recover continuous operation, press the pulse button to select “Continuous”.
Page 6-4
6.1.5. Low Dose Imaging

Low dose imaging is to reduce the exposure dose rate to the patient.
To produce a Low Dose image
1. On HOME panel, press the low dose button on the TechView tablet (control panel) to enable low
dose imaging.
2. Press either pedal on the footswitch or either button on the hand switch to make low dose fluoro
exposures.
NOTE Use of pulsed fluoro and low dose imaging modes will affect image quality.
6.1.6. Extended Exposure Feature

The system provides the option for extended exposure feature. This feature can be set in the C-arm system.
For more information about extended exposure feature, please refer to Chapter 11.
This feature can only be used under the fluoro mode, Low Dose mode, HLF mode or auto pulsed mode. It
will not be activated under the Dig. Spot, manual pulsed mode and Film mode.
With the extended exposure feature enabled, the system will try to provide a usable Last Image Hold (LIH)
capture on very short X-ray control switch activations.
With the extended exposure feature disabled, X-rays will be terminated immediately following the release
of a momentary press of the X-ray switch.
With the extended exposure feature enabled, the icon will appear on the monitor and TechView tablet
(control panel)’s exposure mode status bar.
The maximum amount of time that RADIOSCOPY can continue is limited to 100ms after X-ray control is
released for Irradiation-Event of more than 500ms.
The maximum amount of time that RADIOSCOPY can continue is limited to 500ms after X-ray control is
released for Irradiation-Event of 500ms or less.
Extended exposure function depends on user’s system configuration and compliance with applicable
regulations and standards.
Page 6-5
Imaging
6.1.7. Imaging Mode List

The following list summarizes the modes available on the system. Additionally, it shows the X-ray
techniques available with each mode, the status bar and C-Arm TechView tablet (control panel) display for
each mode, and a brief list of examples for each mode. The examples are not exhaustive and other uses
may be as valid as the examples shown. The user must be aware of the techniques associated with the
various modes and monitor dose rates and doses for each patient.
⚫ Auto: X-ray techniques (kVp/mA) are adjusted automatically by system to optimize the image.
⚫ Manual: X-ray techniques (kVp/mA) are adjusted manually by user to get the desired image.
The user can select Auto or Manual mode listed in the table below as she/he wants.
Mode X-ray Display Imaging Task

Techniques
Normal Fluoro kVp:40 to 110
General fluoro imaging
Auto/ Manual mA: 0.1 to 4
High Level Fluoro kVp:40 to 110 High quality but high dose
Auto/ Manual mA: 0.2 to 12 rate imaging
Low Dose kVp:40 to 110 Continuous fluoro imaging

Auto/ Manual mA: 0.1 to 2 with a lower dose rate
Low Dose High Level kVp:40 to 110 High quality with a lower
Auto/ Manual mA: 0.1 to 6 + dose rate
Pulsed Normal Fluoro kVp:40 to 110 Reduce X-ray dose rate to

Auto/ Manual mA: 0.1 to 4 patient
Pulsed High Level

kVp:40 to 110 High quality and low dose
Fluoro
mA: 0.2 to 12 rate Imaging
Auto/ Manual
Pulsed Low Dose kVp:40 to 110 Reduce X-ray dose rate to
Auto/ Manual mA: 0.1 to 2 + patient
Pulsed Low Dose

kVp:40 to 110 High quality and low dose
High Level
mA: 0.1 to 6 + + rate Imaging
Auto/ Manual
kVp:40 to 110
Digital Spot 0.2 to 20 mA @ 200V,

Short duration, high mA and
220V, 230V, 240V;
Auto high quality single imaging
0.2 to 10 mA @ 100V,
110V, 120V.
Low Dose Digital kVp:40 to 110 Short duration, high mA and
Spot + high quality single imaging
0.1 to 10 mA @ 200V,
Page 6-6
Auto 220V, 230V, 240V; with a lower dose rate

0.1 to 5 mA @ 100V,
110V, 120V.
kVp:40 to 110
Film 1 mAs ~ 80 mAs @ 200V,

Capture an X-ray image on
220V, 230V, 240V;
Manual film
1 mAs ~ 40 mAs @ 100V,
110V, 120V.
Page 6-7
Imaging
6.2. Image Process & Comparison

IMAGE panel includes several functions below, for more information, please refer to Chapter 4.
1 2 3 4 5
6
1. Adjust contrast
2. Adjust brightness,
3. Adjust smart metal
4. Edge enhancement
5. Noise filter
6. Negate
Page 6-8
6.3. Image Quality Control

To get optimal image quality and X-ray dose, ensure the use of default setting by turning on Auto
Contrast/Brightness button and Auto Exposure button. (The parameter mode will display on the TechView
tablet (control panel) ’s exposure parameter bar and right corner of the left area on the monitor ). In
case a substantial portion is composed by a non-anatomy image, use the shutter collimator and/or iris
collimator to cover that portion to minimize the X-ray scatter.
When anatomical thickness varies in region of interest, to get a better image, please stop
NOTE
X-ray and center the region of interest in the imaging field, select auto mode and then
restart the exposure.
Refer to the table below for common image quality issues from less than optimal settings, and the
checklists to resolve those issues.
Item Issue Check Action
1 Image looks too bright Is “Auto Exposure” button turned Turn on “Auto Exposure” button.
off?
Is “Auto Contrast/Brightness” Turn on “Auto
button turned off? Contrast/Brightness” button.
Excessive metal in the field? Turn on “Auto Smart Metal”
button and fine adjust auto smart
metal level.
2 Image looks too dark Is “Auto Exposure” button turned Turn on “Auto Exposure” button.
off?
Is “Auto Contrast/Brightness” Turn on “Auto
button turned off? Contrast/Brightness” button.
When the automatic function is Switch to HLF mode or Digital
selected in normal fluoro mode, Spot mode.
does technique reach maximum
limitation? (110kVp)
Does the non-anatomy portion Re-position the area of interest to
compose too much of the image? decrease the non-anatomy
portion of the image, or use
collimator to cover that portion.
Is the smart metal level too high? Decrease the smart metal level
manually. When there is no metal
in the field, adjust the smart
metal level to “0”.
3 Image looks just Is “Auto Contrast/Brightness” Turn on “Auto
grayish (Too small button turned off? Contrast/Brightness” button or
contrast) manually adjust the contrast
level.
Page 6-9
Imaging
4 Image looks too Is “Auto Contrast/Brightness” Turn on “Auto

black-and-white (Too button turned off? Contrast/Brightness” button or
high contrast) manually adjust the contrast
level.
Does the non-anatomy portion Re-position the area of interest to
compose too much of the image? decrease the non-anatomy
portion of the image, or use
collimator to cover that portion
Is the smart metal level too high? Decrease the smart metal level
manually. When there is no metal
in the field, adjust the smart
metal level to “0”.
5 Image looks too noisy Is the image acquired in Pulsed Switch to continuous mode or
mode? prolong exposure time.
Is the image acquired in Low Dose Switch to continuous mode.
mode?
Is the “Noise Filter” set too low? Increase the noise filter setting.
Is the “Edge Enhancement” level Decrease edge enhancement
set too high? level setting.
6 Image looks blurry Patient or system was moving Decrease the noise filter setting.
(details are not clear) during the acquisition?
Is the “Edge Enhancement” level Increase edge enhancement
set too low? level setting.
Is the image intensifier far away Re-position the image intensifier
from the patient? closer to patient.
Is the region of interest not at the Re-position the region of interest
center of the image? to the center of the image field.
Is the “Field Size” set to 9”? Switch to 6”/4.5” field size.
7 Small field of view Is the “Field Size” set to 6”/4.5” Switch to 9” field size.
(images look too big) mode?
Is the image intensifier far away Re-position the image intensifier
from the patient? closer to Patient.
Page 6-10
Chapter 7. Image Review & Dose
Information Management
Image Review & Dose Information Management
All screens are only for reference, please set up the display language based on the
operator’s country. For more information about the language set up, please refer to
Chapter 11.
7.1. Review Images

Operator may review images by clicking the Mini ID Panel’s activate button. The Mini ID Panel will be
displayed on the right area of the TechView tablet (control panel) and the monitor. Operator may review
images of current exam by using the Mini ID panel.
On the Mini ID panel, review images by scrolling up/down. Select one previewed image to display on the left
area of the TechView tablet (control panel) and the monitor.
Mini ID Panel
Mini ID Panel’s activate button
Page 7-2
The following information will be displayed on the monitor:

2 1
6 5 4 3
1. Display the time that the image was generated.

2. Display patient information.
3. Display auto mode, image contrast value, brightness value, edge enhance value, smart metal value
4. Display technical parameters used during the exposure.
5. Display image reversal, image rotation degree.
6. Display the current image’s sequential position.
At the beginning of each exam, please confirm there is enough image storage space.
NOTE Regularly check the available storage space and archive important records to avoid image
loss.
The Image Directory screen will display saved static images for review and print, archive and review patient
information and dose information.
To display the Image Directory screen on the monitor right area, select the Image Directory button.
Page 7-3
Patient Information.
Complete: Used to complete the selected exam.
Discontinue…Used to discontinue the selected exam.
Dose Summary: Display the dose summary information.
Preview Images: Display image thumbnails to select.
Change Exams…: Used for recalling images that have been previously saved in performed exam.
Report MPPS: Used for reporting MPPS. This button is only displayed when the MPPS option is activated.
Export, Import, DICOM Print, DICOM Storage：Used for exporting exams to media, import exams from
media, DICOM print images and archive images to DICOM Storage Server.
Local Print: Used for printing locally.
Scroll Bar: Used for scrolling through all previewed images.
Split…: Used for removing the selected images, which are not archived to DICOM server, from the
original exam to a new exam.
Select All: Used for selecting all images.
Exit: Exits the Image Directory.
Delete: delete the selected images.
Page 7-4
7.2. Review Dose Information

The Dose Summary screen contains X-ray exposure data of the current exam.
Select the Dose Summary from the Image Directory screen to display the Dose Summary on the left area of
the monitor.
Cumulative
Air Kerma Rate Air Kerma Dose Area Product
Dose information (dose measured at 30cm away from the image intensifier, centered along the reference
axis)
• Dose rate accuracy: ±25%
• Dose accuracy: ±25%
• DAP accuracy: ±25%
The highest value for the Low Dose imaging doesn’t exceed 50% of the highest value for the normal fluoro.
Page 7-5
7.3. Print, Export and Import

Print on local printer
1. Select the Image Directory button to display the Image Directory screen.
2. Select the image which will be printed.

3. Select the “Local Print” to print.
Export to archive devices

The system supports a variety of archive options. Operator can archive images, patient information and
dose summary.
Available storage options include:
• USB: Some removable disks with USB connector can’t be used. OEC One Mobile C-arm X-ray
Product only supports USB disks in Fat16, Fat32, Ext2, Ext3 and Ext4 format.
This section describes how to export from the system to USB. When archiving images, patient information
can be archived with the images.
1. Select the “Export” on the Image Directory screen.
2. Select USB in “Export To” dropdown list.
3. Click “Option” to display Export Options screen.
The Export Options screen allows you to set options for storing images.
Page 7-6
Image Option
File Format:
DlCOM: Standard DICOM format image
BMP: BMP format image
Raw: System original format image, used to import exams among OEC One Mobile C-arm X-ray
Product
Image: The system supports the following modalities:
RF: X-ray Radio Fluoroscopic Image Storage. Default option. 1000 x 1000 pixel, static.
XA: X-ray Angiographic Image Storage. 1000 x 1000 pixel, static.
CR: Computed radiography image storage. 1000 x 1000 pixel, static.
SC: Secondary Capture Image Storage, screen capture type image with Annotation and markers.
1000 x 1000 pixel, static.
Dose Summary:
RDSR: X-ray Radiation Dose Structured Report
SC: Secondary Capture image
Remove Patient Information: Select “Remove Patient Information” to remove all patient identification
information of selected images to copy. This function has no impact on images.
Include DICOM Viewer: Select “Include DICOM Viewer” to record “Media Viewer” application to external
storage devices. This program can browse images from the external storage device with DICOM images.
Include Overlay in DICOM Image: Select “Include Overlay in DICOM Image” to store the overlay
information associated with an image as data separate from the image, such as annotation and
measurement.
The DICOM Viewer should not be used for diagnostic purposes. Its use is limited to
CAUTION
reviewing images.
The viewer can only be used in computer with Java Runtime Environment (JRE) version 1.7
NOTE or above. Media viewer will install it automatically if there’s no Java Runtime Environment
(JRE). The system provides a JRE.exe if choosing “Include DICOM Viewer”.
4. Select correct settings, then click “OK”.

5. Select the preview images to archive. Select Dose Summary to archive. As images are selected, the
capacity, free space of the USB and size of selected images will be updated.
6. If the size of all the images in the directory is smaller than the disk’s free size, choose “Select All” to
select all the images in the directory.
7. Select “Export” on the Image Directory screen. To cancel the export process, click “Cancel” on the
message screen.
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Import from archive devices

1. Select the “Import” on the Image Directory screen.
2. Select the images which will be imported to the system.
3. Click “Import”.
7.4. Retrieve a Performed Exam

Select “Change Exam” from the Image Directory screen. The Performed Exams screen will be displayed on
the monitor right area.
Select an exam and then click “OK”, this exam will be displayed.
Select an image displayed in the Image Directory. The image will be displayed on the left area of the
monitor.
When accessing the performed exams list from image directory and an exam is selected,
NOTE the current exam does not change. If taking an exposure and saving an image while a
performed exam is displayed on the Image Directory screen, the image is saved with the
current exam, not with the performed exam displayed on the Image Directory screen.
Page 7-8
Chapter 8. Image Annotation and
Measurement
Image Annotation and Measurement
8.1. Image Annotation

This section explains how to create annotation and how to use image annotation to place markers, add
comments, and crop images. Image annotation is available based on which configuration has been
purchased.
Select the “Annotation” button.
Select “Exit” to close the Annotation.
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8.1.1. Mark Images

The markers object bar includes L (left), R (right), A (anterior), P (posterior) H (head) and F (foot) markers in
addition to a directional arrow.
1. Click a button in the object bar to select a marker. The marker is displayed on both monitor left and
right area.
2. To position a marker, click on the marker displayed on the right side of the monitor image, and drag it
into position.
3. To add additional markers, repeat steps one and two. A maximum of two of each marker (L, R, A, P, H, F)
can be placed per image.
4. Up to five arrows can be placed on each image.
To delete a marker: select the marker and click “Delete” on the screen.
To save a copy of the image with the markers: press the “Save” on the monitor and TechView
tablet (control panel).
5. Select “Exit” to close the Annotation screen. The annotated image remains displayed on the monitor’s
left area until pressing the X-ray switch is pressed or a saved image is recalled.
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8.1.2. Add Comments on Images

1. Select the “Comment” on the Image Annotation screen. The comment box will be displayed on the
monitor left and right area.
2. Enter text of no more than 80 characters in the comment box.

3. To position the comment box on the image, select the border line of the comment box on the right
area of the monitor and drag it.
4. To add additional comments, select “Comment” and enter another comment. The system allows for
up to five comments of no more than 80 characters each image.
To delete a comment: select it and click “Delete” on the screen.
To save a copy of the image with the comment: press the “Save” on the monitor and
TechView tablet (control panel)
5. Click “Exit” to close the Annotation screen. The annotated image remains displayed on the monitor
left area until the X-ray switch is pressed or a saved image is recalled.
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8.1.3. Crop an Image

Crop shutter allows operator to shade portions of the image on the left area of the monitor.
1. Select the from the Annotation screen. The crop shutter will be displayed on the monitor right area.
2. Select the resize anchors and move them to crop the image. When moving the anchors, the cropped
area of the monitor’s left area images will be hidden from view.
3. Reselect the , and the crop will be deleted on the monitor left and right area. The monitor left area
images will be back to normal.
To save a copy of the cropped image: click the “Save” .

4. Select “Exit” to close the Annotation screen. The monitor left area images remain cropped until pressing
the X-ray switch or display a saved image.
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8.2. Image Measurement

This section explains how to measure an image. Image Measurement is available based on which
configuration has been purchased.
Measurement includes the following options.
• Calibration
• Distance
• Angle
Measurements can be applied to a saved image, a recalled image, and the current image displayed.
The measurements cannot be applied to the images of the “Completed” and “Discontinued”
NOTE exams.
Select “Measurement”: the monitor left area images will be copied to the monitor right area and displayed
in the Measurement screen.
Click “Exit” on Measurement screen, Measurement is closed. The Measurement screen also closes when
X-ray is on.
Page 8-6
8.2.1. Calibration
To perform a calibration between two points, a measuring device should be placed in the plane of interest.
The distance on the image should be marked during calibration and the length value entered in the value
box. Once the value is entered in the box, the reference value for the fixed length is displayed in the upper
right hand corner of the Measurement screen.
When calibration is changed during a procedure, the values in length for of the line adjusts to the new
calibration values.
When zoom is enabled on an image, the reference calibration values are scaled to match the zoom factor.
To perform calibration
1. Select “Calibrate” on the Image Measurement screen to display the Calibration screen.
2. Move the calibration line to set the length.
3. Enter the measured length or catheter size in the calibration value box. Select the calibration unit.
8.2.2. Distance Measurement

The Calibration must be performed before distance measurements can be applied.
The distance calculation is displayed once both end points have been fixed. This value is displayed adjacent
to the ending point.
When calibration is changed during the procedure, the distance measurements are recalculated and the
new values are displayed.
To perform distance measurements

1. Perform calibration.
2. Select “Distance”. A default measurement line is displayed. This line is based on the calibration
performed.
Page 8-7
3. Select the distance measurements unit, it includes mm, inch and French.
4. Select the line and drag the anchor to the appropriate position. The distance measurement will display
adjacent to the anchor.
5. The system allows the operator to enter up to five distances per image.
To delete a “Distance”: click “Delete” on the screen.
To save a copy of the image with distance: click the “Save” .
8.2.3. Angle Measurement

To perform angle measurements
1. Select ”Angle”. An angle will be displayed on the left and right areas of the monitor.
2. Select an angle, adjust length and angle degree by dragging the anchor, the angle degree value will be
displayed at bottom of the angle.
Page 8-8
3. The system allows the operator to place up to five angles per image.
To delete an “Angle”: select an angle, and click “Delete”.
To save a copy of the image with angle: click the “Save” .
Page 8-9
8.3. Zoom
Press the button to activate the Zoom function per magnification: x1/x2/x4.
Page 8-10
Chapter 9. DICOM
DICOM
9.1. Overview
The American College of Radiology (ACR) and the National Electrical Manufacturers Association (NEMA)
developed the Digital Imaging and Communications in Medicine (DICOM) standard.
This section contains information about the DICOM application available on the system that enhances its
functionality. The DICOM application allows the system to connect to and use existing DICOM networks.
You may download the DICOM conformance statement file for OEC One Mobile C-arm X-ray Product from
the website: www.ge.com/dicom.
This section describes how to:
• Connect the system to the network
• Configure the system and DICOM devices
• Query and display scheduled exams’ information
• Query remote server and retrieve images
• Print patient information and images
• Archive patient information, images and dose reports
• Report MPPS
During network transfers, both images and patient information are sent. The patient information may be
the result of a DICOM worklist query, or be manually entered on the system in the Exam Management
screen by the technician.
Page 9-2
9.2. DICOM Setup

The system must be configured to access the DICOM network. Configuration identifies the server to the
network and defines the DICOM network nodes to the system. The DICOM features include:
• Worklist
• DICOM print
• Storage and commitment
• Query & retrieve
• MPPS
Press the “Setup” button on the system panel.

Use this screen to access the “Worklist”, “DICOM Printers”, “Storage and Commitment Server”, “Query &
Retrieve”, “MPPS Server” and network setup screen.
Network Setup
Click “Network & DICOM”. The Network & DICOM setup screen shows on the monitor’s right area.
Input the “Local AE Title” and “Station Name”. User can change it according to the DICOM service’s
requirement.
Local Network Setup

Click “Configure…” of local network to setup the local network.
Input the target IP address, gateway and subnet mask on the screen.
Page 9-3
DICOM
Fill in the information on this screen. The correct information can be obtained from the network
administrator. IP, gateway and subnet mask information need not be input when using DHCP.
Click ”OK” to return to Network & DICOM screen.
Input a target IP address and click “Ping” button to verify the network connection. The results will show in
the text box.
Setup Worklist
The DICOM Worklist server, such as Radiology Information System (RIS), provides scheduled exams’
information.
To setup the Worklist:
1. Select “Worklist” from the setup screen. The Worklist screen will be displayed.
2. Setup scheduled exam date and modality.

3. Click “Add” to display the Worklist Server Config interface. Obtain the following information about the
worklist server from your network administrator and enter it on this interface:
Alias: Unique name, applicable to the system, used to identify the server in the list of available destination
devices.
AE Title: DICOM Application Entity title.
IP Address: Unique IP address assigned to the server being configured.
Time Out: The time in seconds that the system waits for a response from the server before timing
out.
Port Number: Port number assigned to the query server.
Page 9-4
4. Select “Verify” to verify that the server is connected. A verified successful message appears if the server
is connected. Select “OK” to close the screen.
5. Server can be edited or deleted by clicking the relevant button.
6. Select “Exit” to close the Worklist Screen.
Setup DICOM Printer

DICOM printer servers are network nodes that provide print functions in compliance with the DICOM
standard.
1. Select “DICOM Printers” from the Setup screen.
2. Select “Add”.
Obtain the following information from the network administrator for your facility and enter it in the
text-entry fields on this screen:
devices.
Time Out: The time in seconds that the system waits for a response from the server before timing out.
Port Number: Port number assigned to the print device.
Maximum: Maximum print density.
Minimum: Minimum print density.
Config Info.: This value specifies the DICOM printer parameters. It is contained in the DICOM Printer's
Conformance Statement file. The DICOM tag is (2010, 0150) Configuration Information.
Page 9-5
DICOM
3. Select “Border Density...” and choose the image border density. The available options are:
• BLACK
• WHITE
4. Select “Empty Density” and choose the image empty density. The available options are:
• BLACK
• WHITE
5. Select “Copies” and choose the number of copies that will be printed each time a print command is sent
to this printer. The available options are 1 to 10.
6. Select the “Print Priority...” and choose a print priority. The available options are:
• HIGH
• MEDIUM
• LOW
7. Select “Destination” and chose a print destination. The available options are:
• MAGAZINE
• PROCESSOR
8. Select “Medium Type” and choose a medium type. The available options are:
• PAPER
• CLEAR FILM
• BLUE FILM
• MAMMO CLEAR FILM
• MAMMO BLUE FILM
9. Select “Orientation” and choose an orientation. The available options are:
• PORTRAIT
• LANDSCAPE
10. Select “Film Size” and choose a film size. The available options are:
• 8IN×10IN
• 10IN×12IN
• 10IN×14IN
• 11IN×14IN
• 14IN×14IN
• 14IN×17IN
• 24CM×30CM
• 24CM×24CM
Page 9-6
11. Select a film layout for the X-ray images. You can select up to four layouts for each DICOM printer
device you are configuring. There are 10 selection for each layout: 1x1, 1x2, 2x1, 2x2, 2x3, 3x3, 3x4, 4x4,
4x5, 5x4.
The film matrix determines the printed layout for the X-ray images in columns and rows. The matrix
choices are limited to those available from the selected printer. The total number of images printed on
one film sheet is the product of the two numbers.
12. Select “Verify” to verify the printer server is connected. A verified successful message appears if the
server is connected. Select “OK” to close the screen.
13. Server can be edited or deleted in the list by clicking relevant button.
14. Select “Exit” to close the DICOM Printer screen.
Setup Storage and Commitment Server

A DICOM storage server, such as PACS system, is a networked system used to archive images.
1. Select “Storage & Commitment Servers” from the Setup screen.
2. Click the “Add” to add storage server you want to configure.

3. Obtain the following storage information from your network administrator and enter it:
devices.
Port Number: Port number assigned to the storage device.
Page 9-7
DICOM
Overlay: Choose Never Send or Always Send if Available.

Image: The system supports the following modalities:
RF: X-ray radio fluoroscopic image storage. Default option. 1000 x 1000 pixel, static.
XA: X-ray angiographic image storage. 1000 x 1000 pixel, static.
CR: Computed radiography image storage. 1000 x 1000 pixel, static.
SC: Secondary capture image storage, screen capture type image with annotation and markers.
1000 x 1000 pixel, static.
Dose Summary:
RDSR: X-ray Radiation Dose Structured Reporting
SC: Secondary Capture image
Send RDSR on Complete: Check it when sending RDSR on completing an exam.
is connected.
5. Check “Enable Storage Commitment” to setup commitment server.
6. Obtain the following commitment information from the network administrator and enter it:
Time Out: The time in seconds that the System waits for a response from the server before timing out.
7. Check “Use Storage Server Settings” if storage server setting is to be used. The commitment
information will be displayed automatically.
8. Select “Verify” to verify that the commitment server is connected. A verified successful message
appears if the server is connected.
9. Click “OK” to close the screen.
10. Repeat steps 1 through 9 for each Storage and Commitment server on the network. You can edit or
delete server by clicking the relevant button. When all servers have been configured, select “Exit” o
close the Storage and Commitment screen.
Port Number: Port number assigned to the commitment device.
Setup Query & Retrieve

Query & Retrieve Server, is for retrieving the DICOM image information from remote server.
To configure the Query & Retrieve server:
1. Select “Query & Retrieve” from the setup screen.
2. Setup Local Setting.
Local Listening Port
Time Out: The time in seconds that the system waits for data sent back by DICOM Retrieve Server.
Days to Cache Retrieved Images
3. Click “Add” to display the Query & Retrieve Config screen. Obtain the following information about the
Query and Retrieve server from the network administrator and enter it on this screen:
Page 9-8
devices.
Time out: The time in seconds that the system waits for a response from the server before timing out.
Information Model: There are two choices of Information Model:
Study Root: Starts queries at the study level;
Patient Root: Starts queries at the patient level.
is connected. Select “OK” to close the screen.
5. Repeat steps 1 through 3 for each Query & Retrieve server on the network. You can edit or delete
servers by clicking the relevant button.
6. When all servers have been configured, select “Exit” to close the Query & Retrieve Screen.
Setup DICOM MPPS Server

To configure the MPPS server:
1. Select “MPPS Servers” button from the system setup screen.
2. Click “Add” to display the MPPS Server Config screen. Obtain the following information about the MPPS
server from the network administrator and enter it on this screen:
devices.
Page 9-9
DICOM

is connected. Click “OK” to close the screen.
4. Repeat steps 1 through 3 for each MPPS server on the network. Server can be edited or deleted by
clicking the relevant button.
5. When all servers have been configured, click “Exit” to close the MPPS Server screen.
Page 9-10
9.3. Worklist
DICOM Worklist Query feature allows the operator to query the scheduled exams’ information from DICOM
server. User can use the query result to start the exam directly.
1. Make sure the worklist server is setup successfully.
2. Select “Scheduled…” from the Exam Management screen.
Scheduled Exams screen is displayed:
The Scheduled Exams screen displays a list of scheduled exams.

3. Choose a worklist server at the bottom from the server dropdown list.
4. Select “Quick Query” to perform a DICOM query. When the search is complete, the results are displayed
in the Scheduled Exams screen.
5. Select “Advance Query” to setup advance query criteria.
6. Further search can be performed by entering the relevant information in Display Filter to display
desired results matched in scheduled exam list.
7. Click “Delete”, the selected exam will be deleted.
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DICOM
9.4. DICOM Print

Follow steps below to print on a DICOM printer.
1. Make sure the DICOM Print server is setup successfully.
2. Press “Image Directory” button on the system panel. Select DICOM print tab.
3. Choose a layout format.

4. To add an image to the queue box, select the preview image and then click the queue box. User can
continue to select images and load them into the queue until all available positions are filled.
If user selects a preview image and then clicks a box already containing an image, the existing image
will be replaced with the preview image which was selected most recently.
5. Click “Print”.
6. As images are sent to the printer, the print in progress screen is displayed. To cancel the print process,
click “Cancel” on the screen.
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9.5. DICOM Storage and Commitment

The system allows the operator to store images and storage commitment on a DICOM storage server.
1. Make sure the storage and commitment server is setup successfully.
2. Select the “DICOM Storage” tab from Image Directory and then select a DICOM storage server from the
“Send to” dropdown list.
3. Select the image to archive.

4. Click “Send”. The Progress screen will be displayed.
NOTE Check regularly for the available storage capacity and secure/archive important records.
Page 9-13
DICOM
9.6. Query and Retrieve

DICOM Query and Retrieve allows the operator to query the remote server to get DICOM exam information,
retrieve images of desired exams from this server, filter retrieved exams and review retrieved images.
1. Make sure the Query & Retrieve server is setup successfully.
2. Select the “Query & Retrieve” button on the system panel to display the Query & Retrieve screen.
3. Select a Query & Retrieve server from the server dropdown list.
4. Setup the query criteria in Modality, Date, Last Name, First Name, Patient ID and Accession#.
5. Select “Query” to display the results in the table when the search is complete.
6. Select one or more exams in the query result table. Select “Retrieve” to retrieve selected exams from
server and display the retrieved exams in the retrieve result.
7. Select a retrieved exam and select Previous/Next button to display the previous/next image thumbnail.
8. Select “Review Image…” to display Image Viewer, the selected image will be displayed.
9. Select a retrieved exam and click “Delete” to delete the exam.
Page 9-14
9.7. MPPS
A DICOM Modality Performed Procedure Step (MPPS) is an information package that describes the activities,
conditions and results of an exam (imaging procedure) performed on a modality.
The MPPS package provides capabilities of reporting this information back to the connected RIS (Radiology
Information System).
With the DICOM MPPS package the system supports DICOM MPPS as SCU with the following capabilities:
• Provide RIS with exam information
• Report status of the current exam back to RIS
MPPS is only available for some configuration. Check if it’s available before using.
1. Make sure the MPPS server is setup successfully.
2. Click “Complete” or “Discontinue” to complete or discontinue the exams on Image Directory screen.
3. Click “Report MPPS” to report the current exam state to MPPS server.
Page 9-15
Chapter 10. Radiographic Film
Radiographic Film
10.1. Overview
This chapter describes how to use Film mode to produce radiographic films. Film mode is not available in
some countries as local regulations require.
For film imaging, a film cassette holder should be placed on the surface of the image
NOTE
intensifier. Film cassette holder described in this chapter is available as an option part.
10.2. Setup & Make a Film Exposure
Perform the following steps to make a film exposure:
1. In X-ray panel, press the film button on the TechView tablet (control panel), the film indicator will be
on. Under this mode, both left/right X-ray switches of the footswitch and hand switch will be set as Film
mode.
Once Film mode has been selected, the field size and collimator settings are locked. If
NOTE
further adjustments are required, fluoro mode must be entered.
2. Place the cassette holder over the face of the image intensifier with the handle opened out.
3. Rotate the cassette holder handle to securely attach the cassette holder to the image intensifier.
Page 10-2
Verify that the cassette holder is securely attached to the image intensifier. Unsecured
WARNING cassette holders may fall, injuring patients or healthcare personnel.
4. Insert a film cassette into the cassette holder and center it.
NOTE The cassette holder uses friction to hold the cassette. For more information, please refer to
Chapter 15 for cassette sizes.
Verify that the cassette is held securely within the cassette holder. Unsecured film
WARNING cassettes may fall, injuring patients or healthcare personnel.
5. Adjust the radiographic parameters (kVp and mAs) to the desired values.
6. Press and hold any X-ray switch.
During the radiography, press the X-ray switch until the exposure indicator light is off. The
duration of the exposure is signaled by a continuous beep. If the X-ray switch is released
NOTE
before the exposure indicator turns off, system will give four quick beeps, which means the
exposure may not be finished.
7. Release the X-ray switch at the end of the exposure.

8. Remove the film cassette by pulling the cassette out of the cassette holder.
9. Remove the cassette holder, open the cassette holder handle and press firmly against the side of the
cassette holder.
The cassette holder is designed to snugly attach to the image intensifier lip when the handle
NOTE is engaged. It may be necessary to strike the cassette holder with the palm to dislodge the
cassette holder from the image intensifier.
Page 10-3
Chapter 11. System Setup
System Setup
This chapter explains how to setup system function. Features related with DICOM setup such as Network &
DICOM, Worklist, DICOM Printers, Storage & Commitment Servers, Query & Retrieve and MPPS Servers have
already been described in Chapter 9.
Press the “Setup” button on the monitor to access setup features.
11.1. System Information

The System Information screen displays information about Host ID, Serial Number, System ID.
Select “System Information” to display system Information.
Actual version of the software and hardware is based on the system version.
Page 11-2
11.2. Date, Time & Region

Select “Date Time & Region” to display the setup screen.
Use this screen to:
• Enter Date, Time, Time Zone and Language
• Select Date, Time and Number Format
• Select Weight and Height Unit
Select “Exit” to save the setup and return to the desktop.
Page 11-3
System Setup
11.3. C-arm System

Select “C-arm System” tab to display the setup screen.
Use this screen to:
• Enter Hospital Name
• Select Retain Last value at Exam Change or Boot up: Collimator, FOV, Rotation, Flip or Flop
• Setup Exam List Display: Patient ID or Accession#
• Setup B/C Preference: High Contrast or HDR
• Setup Screen Saver Wait Time
• Enable/disable Beep after Saving Image Successfully
• Enable/disable Auto Save at End of Exposure
• Enable/disable Auto Swap
• Enable/disable Display Marker
• Enable/disable Room Interface
• Setup Voltage for Door Opening: High or Low
Click “Exit” to save the setup and return to the desktop.
Page 11-4
11.4. Exposure
Select “Exposure” tab to display the setup screen.
Use this screen to:
• Setup Default Settings at Exam Change or Boot up: Dose, Pulse, Mode Pair
o Select Dose: Standard Dose or Low Dose
o Select Pulse: Continuous, 1 Pulse/s, 2 Pulse/s, 4 Pulse/s or 8 Pulse/s
o Select Mode Pair: Fluoro | HLF or Fluoro | Dig. Spot
• Setup Exposure Sound: Tone and Volume
o Select Tone: 1, 2, 3 or 4
o Select Volume: 1, 2, 3 or 4
• Setup Dose Warning Threshold
• Setup Terminate Short Exposure When
o Select Switch Released or Extended Exposure Completed
Click “Exit” to save the setup and return to the desktop.
Page 11-5
System Setup
11.5. Security
The Security screen is used to setup system for HIPAA compliance.
This feature is only open to the administrator. Click “Security” and enter the administrator password to display
security setup screen. If the administrator password has not been set, the default administrator password is
“123456”.
Use the “Security” setup screen to：
• Require user to login to the system using a password.
• Add /remove user and password.
• Change the passwords.
• Delete all exams.
Select “Require Users to Login”, a login screen will be displayed when the system boots up. The user must enter a
password before proceeding to use the system.
Click “Add” to setup a user name and password. The account will be displayed in the account list.
Select an account and click “Remove”, the account will be removed.
NOTE The administrator account cannot be removed.

Use “Change Password” to change the password.
1. Select the user whose password needs to be changed.
2. Select the “Change Password…”.
Page 11-6
3. Enter the new password in the New Password field.

4. Retype the new password in the Confirm Password field.
5. Select “OK” to return to the “Security” setup screen.
Click “Delete All Exams”. Then a confirmation screen will display. Select “Yes” to delete all exams.
The “Delete All Exams” function deletes all patient information and images from the system.
CAUTION
11.5.1. Screen Saver

Press the button, both monitor and TechView tablet (control panel) will change to the screen saver mode. To
exit the mode, please click anywhere on the monitor or TechView tablet (control panel).
11.5.2. Quick Mode

When user forgets the login password, quick mode can be used to produce images in emergency cases.
Press “Emergency Login” to enter emergency mode screen. User can access Exam Management & Zoom only.
Other applications are disabled. In Exam Management screen, user cannot access Resume Exam and Schedule
Exam feature.
Page 11-7
System Setup
11.6. Maintenance
The “Maintenance” setup screen is used for system maintenance.
Use this screen to:

• Export/Import System Setup
Insert a medium, select the medium from “Medium” dropdown list. Clicking “Export” button allows export of
Setup file/Connectivity configuration file. After the process is completed, a message is shown to indicate file
exported successfully.
Insert a medium, select the medium from “Medium” dropdown list. Clicking “Import” button allows import of
Setup file/Connectivity configuration file. After the process is completed, a message is shown to indicate file
imported successfully.
• Export System Log
Insert a medium, select the medium from “Medium” dropdown list. Click “Export” to export system Log.
• Test Patterns
System provides Test Patterns on the one monitor for the user. Click “Test Patterns” button, Test Patterns
appears on the screen.
• Login Administration
• Login Quality Control
Page 11-8
Quality Control Instruction
Quality Control Mode is not available for some countries according to the regulatory requirement,
NOTE
please contact your regulatory or sales representative when using this feature.
1. Click “Login Quality Control” button to invoke Quality Control Login dialog.
2. Enter User Quality Control Mode
On Quality Control login dialog, input correct Quality Control password (default password is “asdfgh”) and
click OK button, then login Quality Control mode.
3. If user needs to change password, click Change Password button to display Change Password dialog.
4. Verify kVp, mA/mAs, Pulse Width accuracy
- Set imaging mode and techniques on the TechView tablet (control panel) .
Imaging System Set Feedback (Measured) Deviation (%)
Mode
X-Ray Tube X-Ray Tube Current/ X-Ray Tube X-Ray Tube Pulse Width mA/mAs kV Pulse
Voltage (kV) Current Time Product Voltage (kV) Current/ Current (ms) Width
(mA/mAs) Time Product
(mA/mAs)
Film 40 1
Film 40 2
Film 110 2
Film 110 1
Page 11-9
System Setup
Fluoro 99 3.4
Fluoro 66 3.4
Fluoro 40 2.4
Fluoro 110, 4pps 2.4
Pulsed
Take an exposure, the system set value, feedback value, and deviation value will be displayed on screen.
5. Calibrate dose
- Fix dosimeter detector on the center of I.I. surface.
- Set dosimeter to accumulated dose in Gy and reset dosimeter to zero.
- Record the dose value displayed on monitor into the column of dose on monitor before exposure.
- Set the imaging modes and parameters per the selected protocol such as listed below table.
- Take an exposure and hold on for 5~10s then stop exposure.
- Record the dose displayed on the monitor into column of dose on monitor after exposure, and record the
dose displayed on dosimeter into column of measured dose of dose meter.
- Calculate estimated dose in column displayed dose increment.
- Calculate and record Calibration Dose Factor as below:

Calibration Dose Factor= Measured dose of dose meter / (Displayed Dose Increment*0.49)
Mode kV mA Dose on Dose on Displayed Measured Calibration

monitor monitor Dose dose Dose
before after Increment of dose Factor
exposure exposure (mGy) meter
(mGy) (mGy) (mGy)
4pps 80 2.1
- Input Calibration Dose Factor (0.65-1.35), Protocol, Uncertainty (0-100), and Responsible Party on screen
- Click Save button to save the calibration result.
Page 11-10
6. Save Image
- User could click Save button on screen to save images. Thumbnails display on screen.
7. Export FOR PROCESSING IMAGE and RDSR
- Plug in USB stick, and select desired USB partition on screen.
- Click Select All button, click RDSR check box, click Export button, a progress bar displays to indicate progress.
- The selected images and RDSR will be exported to USB stick. The image format is DICOM.
User needs to exit Quality Control Mode to acquire and to export FOR PRESENTATION IMAGE.
NOTE Refer to section 7.3. for details.
8. Click Exit to exit Quality Control Mode. If “Require Users to Login” is selected in Setup screen, system Login
screen displays. If not, Exam Management screen displays with blank exam.
Page 11-11
System Setup
11.7. Network Connection

To use the DICOM interface, please connect the system to the network. User may open wireless network interface
on the system, or plug the network cable into the network connector.
11.8. Login & Log off

Initial password is “123456”.
Press the button to log off.
Page 11-12
Chapter 12. Maintenance and Quality
Assurance
Maintenance and Quality Assurance
12.1. Overview
This section describes routine performance checks that can be performed to ensure that the system is
operating correctly. The performance checks listed are not intended to substitute for scheduled periodic
maintenance. If problems are found during these checks, contact the GE Healthcare authorized service
engineer to troubleshoot and repair the system.
Prior to performing any of the performance checks in this section, it is important that potential hazards
associated with these tasks are understood. Review Chapter 1 of this manual before proceeding.
Circuits inside the equipment use voltages that may cause serious injury or death from
WARNING electrical shock. Do not remove the covers or perform any type of service task, except as
specifically instructed here.
Move the system into a safe operating area prior to beginning these checks and observe all radiation safety
precautions. These checks should be performed as often as equipment is in use and circumstances
warrant. The frequency of performance checks should be increased when the system is used extensively. In
addition, circumstances such as accidents during transport or exposure to excessive fluids may warrant
that performance checks be performed to verify operation of the equipment.
In addition to performance checks, safe cleaning practices are included in addition to a description of
periodic maintenance that should be performed. All periodic maintenance should be performed by a GE
Healthcare authorized service engineer.
The system has an expected service life of 10 years. Periodic maintenance of the system is required to
maintain the system lifecycle. The first periodic maintenance shall be implemented after one year of use.
Then it is suggested to do once per year by a GE Healthcare authorized service engineer.
Protect all the components of the image chain, for example, cover the image intensifier with
lead plate thicker than 3mm, during the quality control mode and quality assurance test.
Page 12-2
12.2. Quality Assurance(QA) Checks

(Performance Check)
This chapter and section “Image quality and dosimetry QA check data form” constitute the required
training material for performing, recording, and monitoring QA tests.
Complete the following QA checks prior to using the OEC One system.
Personnel performing these tests must receive proper training and become fully acquainted with the
recommendations of the National Council on Radiation Protection and Measurements and the International
Commission on Radiation Protection. NCRP reports are available from:
NCRP Publications
7910 Woodmont Avenue
Suite 400
Bethesda, Maryland 20814-3095
http://ncrponline.org/publications
12.2.1. Items of User Routine Quality Assurance Checks

The user of the equipment must follow the user routine check items in the table below. It is for the operator
of the equipment to ensure that all checks have been satisfactorily met before attempting to use the
equipment.
Perform the following checks at the listed frequency. If problems are found during these checks, contact a
qualified service engineer to troubleshoot and repair the system.
Extensive use warrants increasing the frequency of QA checks. In addition, circumstances such as
accidents during transport or exposure to excessive fluids may warrant that QA checks be performed to
verify operation of the equipment. Refer to each QA check section for details on when specific checks may
need to be performed.
Performance Check Item Frequency
C-arm brakes Daily
Brake release pedals Daily
12.2.2. Mechanical System wheels Daily
Performance Quality
Assurance Check Movement of the monitor Daily
Skin spacer Daily
Vertical column Daily
Footswitch and hand switch Daily
12.2.3. Electrical cable
Performance Quality
Power cable Daily
Assurance Check
System start up operation Daily
12.2.4 System Emergency System emergency switch check Daily or as
Switch Quality Assurance
Page 12-3
Check needed
Field size check Daily or as
needed
Auto mode check Daily or as
12.2.5. Fluoro Mode needed
Performance Quality
Assurance Check X-ray footswitch and hand Daily or as
switch check needed
Indicators and buzzer test Daily or as
needed
12.2.6. Film Mode Film Mode Check Daily or as
Performance Quality needed
Assurance Check
1. X-ray QA check Annually or as
needed
-Reference: DIN 6868-57, DIN
6868-150
2. Auto Technique check
-Reference: 21CFR 1020.30
(h)(3)(vi), 21CFR 1020.30 (h)(3)(vii)
3. Half Value Layer (HVL) check
– Reference: 21 CFR 1020.30
(m)(1), IEC 60601-1-3:2008 cl.7.1,
NEMA XR 27
4. Image resolution check
-Reference: Internal spec
equivalent to IEC 61223-3-1
12.2.7 Image quality and 5. Dose Rate Limitation Check
dosimetry QA checks (Skin Dose rate) – Reference: 21
CFR 1020.32(d)(2)
6. Reference Air Kerma Rate (AKR)
accuracy check – Reference: 21
CFR 1020.30(h)(6)(i), 21 CFR
1020.32(k)(4), 21 CFR
1020.32(k)(6), IEC
60601-2-43:2010 cl. 203.6.4.5
7. Reference Cumulative Air
Kerma (CAK) accuracy check –
Reference: 21 CFR 1020.30
(h)(6)(i), 21 CFR 1020.32(k)(4), 21
CFR 1020.32(k)(6), IEC
60601-2-43:2010 cl. 203.6.4.5,
NEMA XR 27
8. DAP Accuracy
Page 12-4
Check–Reference: NEMA XR 27
9. kVp, mA/mAs, Pulse Width
Accuracy Check- Reference:
NEMA XR 27
10. Dose Reproducibility and mA
linearity Check- Reference: NEMA
XR 27
11. X-ray tube output
measurement- Reference: NEMA
XR 27
German X-Ray ordinance Roentgenverordnung (RöV) §16 and Qualitätssicherungs-Richtlinie (QS-RL) 3.1.3.8
require the SMPTE test pattern to be displayed on the system monitors for testing per Feb 2001 DIN V
6868-57. Clicking “SMPTE Test” button on Maintenance Setup Test Patterns screen, the operator can
perform SMPTE test on the monitor.
Before using the equipment, verify that system operation is proper according to the check
CAUTION items above. System that is not fully functional may result in delays in medical treatment.
12.2.2. Mechanical Performance Quality Assurance Check

1. Check the brakes operation. Check the Horizontal brake, Wig-wag brake, Lateral brake, Orbital brake
Rotation, Spring arm brake and extension arm brake for ease of movement without excessive play.
2. Check the operation of the brake release pedals. Ensure the system movement can be locked.
3. Check for proper control of the system wheels. Check for ease of movement without excessive play.
4. Check movement of the monitor arm for ease of movement without excessive play. Make sure that the
monitors do not swing rotation after being positioned.
5. Check the skin space mounts to X-ray tube cover. If the skin spacer is not available, obtain a
replacement.
6. Vertical column movement functionality is normal.
12.2.3. Electrical Performance Quality Assurance Check

1. Inspect the footswitch and hand switch cables for signs of wear or abrasion, loose, missing or bending
connector pins, and worn strain reliefs.
2. Inspect the power cable for sign of wear or abrasion, loose, missing or bending connector pins, and
worn strain reliefs.
3. Turn the system on and verify that the system successfully completes the power on sequence.
Some devices such as electrolytic capacitors can retain a dangerous static charge for long
WARNING periods after power has been removed. Do not touch these components unless power has
been completely removed and they have discharged.
Page 12-5
12.2.4. System Emergency Switch Quality Assurance Check

Images will be lost when the system is restarted unless the operator have saved them. If
NOTE
images have been saved, the operator can access them through the Image Directory
function.
This check is performed as a matter of routine operator maintenance to ensure that the Emergency Switch
safety feature is functioning properly. Perform this check as often as possible in conditions such as removal
from long-term storage and exposure to fluids.
1. Press and hold the vertical column control button then press Emergency Switch while motion.
2. Verify that vertical column motion stops.
3. Press footswitch/hand switch to verify that X-rays are disabled. (The exposure indicator is off.)
4. Press the power on/off button to power off the system.
5. Rotate the Emergency Switch upward and then reboot the system.
12.2.5. Fluoro Mode Performance Quality Assurance Check
WARNING The procedures in this section will produce X-rays. Take the appropriate precautions.
1. Position the system so that the image intensifier is directly below the tube.
2. Place a suitable test object adjacent to the image intensifier.
3. Verify that auto mode is selected.
4. Press the left X-ray switch on footswitch or hand switch. Verify that a digitized fluoro image of the
5. object appears on the monitor left area and that it remains there after the exposure is terminated.
6. Verify operation of the field size selection buttons: 9”/6”/4.5”.
7. Verify the exposure indicator on monitor is lit and exposure beep sound from buzzer during X-ray on.
Page 12-6
12.2.6. Film Mode Performance Quality Assurance Check
This procedure produces X-rays. Take the appropriate precautions.

WARNING
1. Press the film button on the TechView tablet (control panel) to select film mode.
2. Install the film cassette holder on the image intensifier and load a film cassette.
3. Press the footswitch and hand switch until the exposure indicator light is off. The system will give
continuous audible beeps during the exposure. If the X-ray switch is released early during exposure,
the system will give intermittent beeps to warn that the exposure has been interrupted.
4. Develop the film and inspect the exposure.
12.2.7. Image Quality and Dosimetry Quality Assurance Checks

The following section addresses the parameters, their specifications, tests, tools, quality standards,
acceptance limits and action limits for the QA tests. All tools must be calibrated before use.
These checks must be performed by personnel appropriately authorized, trained, qualified, certified, and/or
licensed to use the system and to perform the required testing, such as certified/licensed radiologic
technologists and licensed medical physicists knowledgeable about the principles and techniques for
image quality and dosimetry testing and evaluation.
Professional medical physicist societies include:
• American Association of Physicists in Medicine: http://www.aapm.org
• International Organization for Medical Physics: http://www.iomp.org
• European Federation of Organizations for Medical Physics: http://www.efomp.org
Monitor the QA checks over time for system performance. In case of concerns, please consult your service
representative. If problems are found during these checks or if problems persist after suggested
troubleshooting, contact a qualified service engineer to troubleshoot and repair the system.
Page 12-7
12.2.7.1 X-Ray QA Check

1. Boot up the system, and refer to section 12.2.5, to complete Fluoro Mode Performance Quality
Assurance Check.
2. Press “Setup” button on the right side of the monitor, then select “Maintenance Test
PatternsSMPTE Test” to display the SMPTE test patterns on the screen.
Figure 12-1: Test pattern showing the grid lines (A), 95% contrast field (B), and 5% contrast field (C).
A. Verify that the boxes of grid lines (A) are visible.
B. Verify that the 95% (B) contrast fields are visible.
C. Verify that the 5% (C) contrast fields are visible.
3. Click “Exit” button to return to normal screen.
If this test fails, ensure that at least 20 minutes have passed since the system was started up. View the
monitor from no further away than 2 meters. Check the Contrast and adjust ambient light for improved
visibility, and then try again.
Page 12-8
12.2.7.2 Auto Technique Check

1. Make sure that X-ray tube cover is installed.
2. Position the C-arm with I.I. above the X-ray tube.
3. Select auto fluoroscopy mode, and the norm field size to take an exposure. Put the 1mm, 2mm, and
3mm copper filter on the tube head.
1. Verify that the kVp stabilizes in the specified range below for each copper filter thickness:
Copper Filter Thickness 1mm 2mm 3mm

kVp range 64±4kVp 74±4kVp 82±4kVp
2. If the ABS tracking check fails, perform kVp accuracy check. If kVp accuracy check passes,
perform entrance dose rate check and camera iris adjustment.
If this test fails, ensure the test procedure is correct, then try it again.
12.2.7.3 Half Value Layer (HVL) check

Required equipment: Dosimeter, measuring tape, and a set of 10cm x 10cm aluminum plates. 11000 Alloy
(at least one 0.5mm thick plate, five 1mm thick plates, and five 0.1mm thick plates)
If a dosimeter that measures HVL is available, steps 7-11 below are not required. Use the
NOTE
instructions provided with the dosimeter to measure HVL.
1. Position the C-Arm with the X-ray Tube up and the image receptor down.
2. Ensure that the collimator cover has been installed.
3. Set up the dosimeter to measure dose rate (AKR).
4. Disable Auto Technique on the C-Arm TechView tablet (control panel) , and manually set the technique
to 80 kVp.
5. Using the mounting bracket and stand provided with the meter, mount the ion chamber/dose detector
on image receptor cover.
6. Fluoro and center the ion chamber/dose detector as viewed on the Workstation monitor.
The HVL is a measurement of beam quality. The components that contribute to the HVL are
NOTE
the X-ray tube and cover, primary and variable collimators.
7. With no aluminum (0 mm) plates in the path of the beam, make a fluoro exposure until the AKR on the
Dosimeter stabilizes.
8. Note the initial (0 mm) AKR reading.
9. Divide the AKR reading by 2 to determine the ½ AKR value.
10. Continue to fluoro and add aluminum plates to the path of the beam (at the closest point to the
collimator) until the AKR value reaches the value calculated in step 9.
Page 12-9
11. When the AKR reading reaches the ½ value calculated in step 9, the total thickness of plates placed
in the path of the beam is the system's Half Value Layer.
12. Verify that the HVL is ≥ 2.9 mm Al @ 80 kVp.
If this test fails, ensure that the dosimeter probe is centered above the grid, and then try again.
12.2.7.4 Image Resolution Check

Place spatial resolution tool in the front of the image intensifier. The angle between the horizontal axis of
the image and the resolution tool must be 45°. Select the auto fluoro or set the appropriate kV value. Take
an exposure and stop once image is stable. The image is frozen on the left area of monitor. Verify the
resolution in the specified range below for each field size (MAG NORM, MAG1 and MAG2).
Field Size MAG NORM MAG1 MAG2

Resolution (Lp/mm) 2.2 2.8 3.3
12.2.7.5 Dose Limitation Check

Normal Fluoro Dose Rate Check:
1. Position the C-arm with the generator above the image intensifier.
2. Position the detector of dosimeter at the center of the X-ray beam 30cm above the grid of image
intensifier. Cover the image intensifier with lead plate thicker than 3mm.
3. Set kVp as 110kVp, set mA as 4mA in manual mode. Measure the dose rate while making exposure.
Limits vary by the dose group, which was configured by country in software configuration section.
4. Verify the corresponding dose group according to country’s dose group requirement.
Normal Fluoro: ≤ 47.5mGy/min (Dose group: Normal 50 and HLF 50)

≤ 47.5mGy/min (Dose group: Normal 50 and HLF 100)
≤ 83.6mGy/min (Dose group: Normal 88 and HLF 100)
HLF: ≤ 47.5mGy/min (Dose group: Normal 50 and HLF 50)

≤ 95mGy/min (Dose group: Normal 50 and HLF 100)
≤ 95mGy/min (Dose group: Normal 88 and HLF 100)
12.2.7.6 Reference Air Kerma Rate (AKR) Accuracy Check

1. Create a new exam. Make sure the collimator iris is open to maximum.
2. Put detector of dosimeter on the I.I. surface in the beam axis. Take an exposure in auto mode, observe
and adjust the dosimeter detector to the center of I.I. set dosimeter to dose rate in Gy/min.
Page 12-10
3. Set the exposure modes and parameters listed below, take an exposure, when the reading of dosimeter
is stable, record the dose rate displayed on the monitor and record the dose rate displayed on
dosimeter into below column. Calculate and record deviation as follow:
Monitor Displayed Deviation

Measured Dose Rate
Mode kV mA Dose Rate (Pass criteria
(mGy/min)
(mGy/min) <25%)
Normal 45 2 %
12.2.7.7 Reference Cumulative Air Kerma (CAK) Accuracy Check

1. Fix dosimeter detector on the center of I.I. surface.
2. Set dosimeter to accumulated dose in Gy and reset dosimeter to zero.
3. Create a new exam. Record the dose value displayed on monitor into the column of dose on monitor
before exposure. Set the exposure modes and parameters listed below. Take an exposure and hold on
for 5~10s then stop exposure. Record the dose displayed on the monitor into column of dose on
monitor after exposure, and record the dose displayed on dosimeter into column of measured dose of
dose meter. Calculate estimated dose in column displayed dose increment.
4. Calculate and record deviation as follow:
Mode kV mA Dose on Dose on Displayed Dose Measured dose Deviation

monitor before monitor after Increment of dose meter (Pass criteria
exposure (mGy) exposure (mGy) (mGy) (mGy)
<25%)
4pps 80 2.1 %
Page 12-11
12.2.7.8 DAP Accuracy Check

1. Position C-arm to AP position, the monoblock is at the bottom and I.I. is at the top.
2. Create a new exam.
3. Install BAFT/UBAT on I.I.. Set the Mag mode to Mag2. Take an exposure in auto fluoro mode and hold
on. Close iris a little by pressing the iris collimator close button on TechView tablet (control panel) until
at least two opposite leaves are visible on monitor, then stop exposure. Read the distance on BAFT
between any pair of opposite leaves. Record the value in column “Diameter”. The unit should be mm.
Refer to the above manner to measure the diameter of Mag1 and Normal mode. Remove BAFT from
I.I..
The semi-transparent part of leaves shall be considered. The measurement shall start and
NOTE
end at the middle of semi-transparent area.
4. Fix dosimeter detector on I.I. surface. Take an exposure in auto fluoro mode, observe and adjust the
dosimeter detector to the center of I.I. surface. Set up the dosimeter to accumulated dose in Gy and
reset dosimeter to zero.
5. Set the kVp/mA and exposure mode as the parameters in table shown below and do measurement in
sequence. For each measurement, record the DAP displayed on monitor into column “DAP on monitor
before exposure”, then take an exposure for at least 20 seconds. After exposure finish, record the DAP
displayed on monitor in column “DAP on monitor after exposure”. Record the measured dose of
dosimeter in column "Measured dose of dose meter". Reset the dosimeter after each measurement is
done.
6. Calculate as follow and record DAP estimated in column “DAP estimated on monitor”.
7. Calculate as follow and record Deviation in the table below.
8. Repeat step 3 ~step 7 to measure and record the DAP deviation of Mag1 and Normal.
Mode kVp mA Mag Diameter Measured DAP on DAP on DAP Deviation

(mm) dose of monitor monitor estimated (Pass
dose before after on criteria
meter exposure exposure monitor <25%)
(mGy) (Gy.cm2) (Gy.cm2) (Gy.cm2)
Normal 105 3.6 Mag2 %
Fluoro
4PPS 80 2.1 Mag1 %
Normal 45 2 Normal %
Fluoro
If system cannot pass the check, perform the collimator calibration and DAP calibration,
NOTE
then perform this check again, until system passes the check.
12.2.7.9 kVp, mA/mAs, Pulse Width Accuracy Check

Refer to section 11.5. Maintenance for kVp, mA, pulse width accuracy check.
Page 12-12
12.2.7.10 Dose Reproducibility and mA linearity Check

1. Put dose meter sensor on the I.I. surface center. Place aluminum pieces on the tube cover, the
thickness is indicated in Filtration Aluminum Thickness (mm) row.
2. Set the imaging mode as film mode.
3. Make 10 measurements of dose (AIR KERMA) in one hour under the test conditions, at each of the test
settings A, B, C, D, E and F according to the table below.
AIR KERMA: 10 measurements in 1 hour at each setting

Test settings for: A B C D E F
X-RAY TUBE VOLTAGE (kV): 40 110 55 88 55 88
Q=CURRENT TIME PRODUCT (mAs): 10 10 Q1(a)=5 Q1(b)=2 Q2(a)=6.3 Q2(b)=2.5
FILTRATION ALUMINUM THICKNESS 4 40 16 30 16 30
(MM)
Test No. Measured AIR KERMA (mGy)
1
2
3
4
5
6
7
8
9
10
Average value of dose (AIR K1(a)= K1(b) = K2(a) = K2(b) =
KERMA):
Measured coefficient of
variation:
4. Calculate the dose reproducibility by coefficient of variation(COV) for each of the measurement series
and the average dose according to the definition below. Dose reproducibility is concluded with
maximum value calculated.
Page 12-13
COV definition:
x means measured value of dose and n is 10.

5. Calculate mA linearity by these average dose and mAs at these test settings C, D, E and F according to
the definition below.
Linearity definition:
K means value of dose of each setting, Q means mAs value of each setting.
12.2.7.11 X-ray tube output measurement

1. Power on the system. Place the dosimeter detector at the center of I.I. surface. Power on the dosimeter.
Set dosimeter to accumulated dose and reset dosimeter to zero.
2. Set the imaging mode as Film mode and X-ray technique as 80kVp and 1.0mAs.
3. Take an X-ray exposure, measure and record the dose. The tested dose shall be greater than 26.52
uGy.
Page 12-14
12.2.7.12 Image Quality and Dosimetry QA Check Data Form

Complete as part of the image quality and dosimetry QA checks and retain for your records.
QA check Parameters Specifications Measurement
X-ray QA Contrast/ Visibility of boxes of grid lines
Brightness
95% contrast field is visible
5% contrast field is visible
Auto Technique kVp 1 plate (1mm of Copper): 66~68kV
Half Value Layer HVL in mm AL >=2.9 mm @80kVp
Tools Dosimeter #:
Measureing tape #:
Image Resolution Image resolution Normal >=2.2
in Lp/mm
Mag 1 >=2.8
Mag 2 >=3.3
Tool Line pair converging tool #:
Dose Rate Maximum dose Fluoro ≤ 47.5 mGy/min (Normal 50
Limitation Check rate in mGy/min and HLF 50, Normal 50 and
(Skin Dose rate) HLF 100)
≤ 83.6 mGy/min (Normal 88
and HLF 100)
HLF ≤ 47.5 mGy/min (Normal 50
and HLF 50)
≤ 95 mGy/min (Normal 88 and
HLF 100, Normal 50 and HLF
100)
Tool Dosimeter #:
Reference AKR %error ±25%
Tool Dosimeter #:
Reference CAK %error ±25%
Tool Dosimeter #:
DAP %error ±25%
Tool Dosimeter #:
kVp, mA/mAs, Pulse kVp ±7%
Width %error
(Max.)
mA %error ±10%
(Max.)
Page 12-15
QA check Parameters Specifications Measurement

mAs ± (10 % + 0.2 mAs)
%error
(Max.)
Pulse Width ± (10 % + 1 ms)
%error (Max.)
Tool N/A
Dose Dose 0.045
Reproducibility and Reproducibility
mA linearity (Max.)
mA linearity (Max.) 0.18
Tool Dosimeter #:
X-ray tube output Dose 26.52 uGy
Tool Dosimeter #:
Page 12-16
12.3. Periodic Maintenance

Periodic maintenance must be performed by qualified and authorized service engineers. In this context:
• Qualified means that the service engineer has been trained and has had practical experience in the
required routines so that he/she is capable of performing service work on the system.
• Authorized means that the service engineer is recognized by the system owner as a qualified service
engineer and is therefore authorized to perform maintenance work on the system.
The following periodic maintenance schedule is recommended.
Item Description Frequency
Earth (Ground) Check maximum earth resistance of whole system Annually
Power supplies Check earth leakage current Annually
Check internally- generated DC voltages Annually
Check no battery leakage Annually
Check the appearance is normal Annually
Batteries Check the cable connection Annually
Check the battery life, check the necessary of Annually
replacement
PCB and racks Ensure installation securely and check for dust and Annually
corrosion
Powered lock Check powered lock controls Annually
Controls and Indicators All controls Annually
All visible / audible indicators Annually
Movement Annually
Alignment (calibration) Beam alignment, centering and field limitation Annually
Dose check Dose accuracy Annually
Mechanical Counterweight fasteners and cables Annually
All mechanical stops Annually
Wheels and wheel alignment Annually
Check Bearings movement freedom Annually
Cleaning dust on system filter and fan (beside system Annually
wheels) and check functioning
Brakes and locks Annually
Function Check all system function Annually
Page 12-17
12.4. Cleaning
Before cleaning and disinfecting the equipment, make sure the system is turned off and the
WARNING power cord is unplugged to avoid electrical shock.
Biohazards may be present on surface of the equipment. Wear rubber gloves during
cleaning.
The system is not waterproof. Be careful not to spill or splash liquids where they can enter
CAUTION
electronic assemblies.
Make sure the system is turned off and unplugged before cleaning. Clean the covers and panels
periodically with a damp cloth. Use a mild detergent, if necessary, to remove scuffs, stains and dust. Do not
use any solvents that may damage or discolor paint finishes or plastic components.
Do not drip liquids where they can enter electronic assemblies through panel or cover seams.
Water, soap, or other liquids, if allowed to drip into the equipment, can cause electrical
WARNING short circuits leading to electric shock and fire hazards.
If liquids should accidentally spill into the system, do not connect power cord to power
supply or turn the system on until the liquids have dried or evaporated completely.
Always turn the system off and disconnect power plug before cleaning. Clean the external
CAUTION connector area with dry cloths only. Do not use liquid cleaners on this area.
12.4.1. Approved Cleaning Agents

The following cleaning agents are approved for cleaning the system.
• MadaCide-FD germicidal solution
• Virex II 256
• CaviCide
• Isopropol Alcohol (90%)
Do not spill or splash liquids where they can enter electronic assemblies.
CAUTION
Always turn the system off and disconnect power before cleaning.
Do not spray or use liquid cleaners in areas of electrical connections.
Do not let the system sit soiled for longer than 4 hours.
Page 12-18
Procedure
1. Clean the system after each use.
2. Ensure the system has been properly shut down.
3. Unplug the power cord from the wall outlet.
4. Clean with any of the approved cleaners / disinfectants according to the instruction of cleaners /
disinfectants.
5. To clean the system, apply liquid cleaners to a cloth and gently wipe surfaces. Be careful not to drip
liquids where they can enter electronic assemblies through panel or cover seams.
6. Detach the skin spacer from the C-arm and gently wipe all surfaces.
7. Rinse skin spacer with water and wipe with a clean cloth and / or swab to remove any excess liquid.
8. Use a soft bristle brush to clean seams and crevices.
9. Apply liquid cleaners directly to the brush and gently brush surfaces.
10. Clean all surfaces thoroughly to remove any signs of soil, paying special attention to parts of the
system that may be positioned over the patient.
11. Rotate the C-arm and actuate all moveable parts to access all areas of the system. Pay special
attention to the C-arm cables.
12. To clean the monitor, apply approved cleaners to a cloth and gently wipe. Do not spray liquids directly
on the monitor.
13. To clean the power cord, apply approved cleaners to a cloth and gently wipe the cord, As the cord is
cleaned, wrap the cord around the Power Cable Hanger. Ensure that the cleaned cord does not contact
the floor.
14. Inspect surfaces to ensure that there is no remaining soil.
15. Repeat cleaning steps if necessary.
Liquids, if allowed to drip into the equipment, may cause electrical short circuits leading
WARNING to electric shock and fire hazards.
If liquids should accidentally spill into the system electronics, DO NOT connect the power
cord to a power supply connection or turn the system on until the liquids have dried or
evaporated completely.
Page 12-19
12.5. Storage
12.5.1. Temporary Storage (less than 60 days)
To prepare the system for storage, move all mechanical assemblies into their most compact position, set all
locks and brakes and remove all power. Coil the power cable.
Cover the system with a dust cover. For more information, please refer to Chapter 15 for the range of
environmental conditions in which the system can be safely stored.
12.5.2. Long Term Storage or Shipment (60 days or more)

To prepare the system for long-term storage or shipment, observe the following recommendations:
• As the description in Chapter 3, move all mechanical assemblies into their most compact positions,
lock all the brakes and handles and remove all power. Coil the power cable.
• Wrap the image intensifier, X-ray tube assembly and the TechView tablet (control panel) housing
with separate pieces of bubble wrap. Make sure the monitor is secured. Wrap the monitor with
bubble wrap.
• Pack all accessories such as cassette holder and store them with the system.
• Cover the system and accessories. Attach each to a solid supportive shipping base and enclose in a
protective container adequate for shipment or storage. For more information, please refer to
Chapter 15 for the range of environmental conditions in which the system can be safely stored.
When the system is not likely to be used for some time and before transportation, battery
WARNING should be disconnected by pressing emergency switch.
Page 12-20
Chapter 13. Display Messages
Display Messages
13.1. Overview
This chapter describes messages that appear on the monitor right area and on the TechView tablet (control
panel) during system operation. Messages may indicate any of the following:
• Error messages
• Warning messages
• Information
When an error message appears, an error code will be displayed both on the TechView tablet (control panel)
and the monitor.
13.2. Error Recovery Steps

Perform the following error recovery procedures if you encounter problems during start-up or operation:
1. Some messages can be cleared by pressing “OK” or taking exposure, but will periodically re-display
while the condition exists.
2. If an error message occurs, power off the system. Wait for one minute, and then reboot the system. If
this fails to restore normal operation, then proceed with step 3.
3. Press the power on/off button to power off the system, disconnect the power cord, and call for service.
Refer to chapter 1 for communication center telephone numbers. Do not continue using the system.
System may fail at any time. Ignoring error and warning messages may result in equipment
WARNING damage and personal injury.
13.3. Messages
Each message shown on the right area of the monitor when operating the system contains the information
of error description, how user will be affected and action suggested. For the detailed message list, please
refer to Service Manual.
Page 13-2
13.4. Virtual Keyboard
Holding the key down for a long time on virtual keyboard will not input the character continuously. The key
must be released and then press again to input the same character.
For the physical keyboard connected to system, the character will be displayed continuously when press
and hold the physical keyboard key.
European Soft keyboard:
EU keyboard provides two methods for inputting EU characters:
1. Group input: input diacritics->base letter->generate EU character. For example, first input ,
then input and the character can be generated.

2. Keyboard input: input the characters "á", "å", "ä", "à", "ö", "ó", "ü", "ù", "ú", "é", "è", "ë", "ñ", "í", "ï"
directly by keyboard.
To input the capital EU characters, the button should be enabled.
Page 13-3
Chapter 14. Labels and Symbols
Labels and Symbols
14.1. Overview
This chapter describes labels and symbols that are located on the C-arm.
Two types of labels are described: warning labels and regulatory certification labels. Warning labels define
potential hazards and advise against misuse that might result in personal injury. Personnel need to be
familiar with these labels and their meanings in order to ensure a safe environment for both the patient
and all healthcare personnel. Regulatory labels indicate that the system meets the requirements of specific
governmental, medical and industrial organizations.
Symbols are provided to visually represent concepts.
This manual supplies only with English labels, some labels may have a foreign language
NOTE
equivalent that will appear on applicable systems.
14.2. Labels and Locations

14.2.1. Labels
Item Label Quantity Description
OEC One system label indicates
model number, serial number,
technical parameters and
manufacturer information.
1 1
Page 14-2

X-ray generator label indicates
model number, part number, serial
number, technical parameters, and
2 1
Total Filtration label
Image intensifier label indicates

model number, part number, serial
number, and manufacturer
information.
3 1
Page 14-3
Labels and Symbols

Beam limiting device label indicates
model number, serial number, and
4 1
Laser aiming device label of image

intensifier indicates model number,
serial number, and manufacturer
information.
5 1
Laser aiming device label of tube

indicates model number, serial
information.
6 1
Skin spacer label indicates model

information.
7 1
Page 14-4

Spot film device label indicates
model number, serial number, and
8 1
Removable filter label indicates

model number, manufacture date
and manufacturer information.
9 1
Removable grid label indicates

10 1
Video distributor label indicates

11 1
Horizontal wig-wag Indication

Label
The label indicates the horizontal
Wig-wag brake’s position of the
12 1 C-arm. Rotate the handle to the
unlocked position to enable the
Wig-Wag movement of the C-arm.
Rotate the handle to the locked
position to lock the Wig-wag
movement of the C-arm.
Page 14-5
Labels and Symbols

Lateral rotation motion indication
scale (Left)
The label indicates the lateral
rotation brake’s position of the
C-arm. Rotate the handle to the
13 1 unlocked position to release the
brake. Rotate the handle to the
locked position to lock the lateral
rotation movement.
Lateral rotation motion indication

scale (Right)
The label indicates the lateral
rotation brake’s position of the
locked position to lock the lateral
rotation movement.
Orbital motion indication label (Left)

The label indicates the orbital
rotation brake’s positon of the
locked position to lock the orbital
rotate movement.
Orbital motion indication label

(Right)
The label indicates the orbital
rotation brake’s positon of the
16 1 C-arm. Rotate the handle to the
unlocked position to release the
locked position to lock the orbital
rotate movement.
Page 14-6

Horizontal motion indication label
The label indicates the horizontal
across arm brake’s position of the
locked position to lock the
horizontal movement.
Potential equalization terminal label

The label is located next to
potential equalization terminal of
18 1 the system, indicating the potential
equalization terminal position of the
system.
This label on the foot switch means

that the degree of protection of the
foot switch is IPX8. The electrical
19 1
mechanism within the foot switch is
protected from the effects of
continuous immersion in water.
Emergency switch label
This label near the emergency
switch indicates the location of
emergency switch.
20 1
CE Label
This label indicates the equipment
was tested by a Notified Body and
21 1 was found to be in compliance with
the requirements of all relevant
directives and standards in effect
within the European Union at the
time of manufacture.
Page 14-7
Labels and Symbols

WEEE CSA label
Left side of this label indicates that
waste electronic and electrical
equipment must not be disposed of
as unsorted municipal waste and
must be collected separately.
Please contact an authorized
representative of the manufacturer
22 1 for information concerning the
decommissioning of your
equipment. Right side of this label
indicates the system was tested by
CSA authorized body and was
found to be in compliance with the
requirements of all relevant
directives and standards at the
time of manufacture.
This is the label of branding.

23 2
X-ray sources label

This label can be found on the X-ray
generator. It indicates the location
of the X-ray source and the controls
24 1 used to produce ionizing
X-radiation. Use appropriate
precautions and protective
equipment when using the system
and at all times when X-rays are
present.
System weight label
The label indicates the system
weight.
25 1
Page 14-8

WIFI label
The WIFI label with FCC/IC ID. Only
26 1 available when you choose Wi-Fi
Internet Adapter option for some
configurations.
Circuit breaker label
The label indicates that the circuit
27 1 breaker or other over current
protector used in power supply for
this product meet the requirements.
Transport position warning label

The label indicates the position
while transporting the system.
Before moving the system, lower
the C-arm to the lowest position,
then move the C-arm horizontally
to the positon closest to the
console and lock the horizontal
1 handle, place C-arm in the middle
28
of the swing and lock the C-arm,
check that all parts are in the
locked positon.
Place the monitor using the monitor
handle, check that the monitor
spring arm brake handle is in
locked position. Then move the
system, refer to chapter 3.
Pay attention to your feet keep

away from this area.
29 1
Monoblock heat label

Long time exposure can make the
monoblock hot, the label warns the
30 2 operator to take care and prevent
burns.
Page 14-9
Labels and Symbols
Shut down warning label

The label is located next to the
31 1 power on button of the system,
indicates the correct steps to shut
down and restart the system to
avoid data loss.
Use caution in this area to avoid

injury to hands and fingers.
32 8
External device interface warning

label
This label is located next to the
external device interface, indicates
that the operator
should not touch the connector and
33 1 the patient at the same time. The
connector must be connected to
the appointed device only.
This port is only used to store
patient image by USB disk.
Connection with any other
equipment is strictly forbidden.
Laser aimer warning label
The label is located on the laser
aimer that is on the image
34 1 intensifier, indicating the operator
and patient should not to look
directly at the laser beams.
Page 14-10

Laser Aimer Warning Label
intensifier, indicating the operator
35 1 laser reflector's effect on the image.
Laser Aimer Warning Label

intensifier, indicating the operator
36 1 and patient should not look directly
at the laser beams.
Laser aimer WEEE label

This label indicates that waste
electronic and electrical equipment
must not be disposed of as
unsorted municipal waste and
37 1 must be collected separately.
Please contact an authorized
representative of the manufacturer
for information concerning the
decommissioning of your
equipment.
Laser Aimer warning label

aimer that is on the monoblock,
indicating the operator and patient
38 1 not to look at the laser beams
directly with optical instructions.
Page 14-11
Labels and Symbols

Laser warning label
aimer that is on the monoblock,
indicates the operator and patient
39 1 should not look directly at the laser
beams.
Booting warning label

power on/off
40 1
button, indicating that the user
should operate the USB storage
device as required.
X-ray warning label

The label is located on the
generator. When the system is
41 1 producing X-rays, operating
instructions should be followed.
Storage label on foot switch.

image’s storage button. Pressing
42 1 the button will save the monitor’s
left area image.
Foot switch fluoro mode label

The label is located on the foot
43 1 switch. If the button is pressed, the
left side’s exposure mode will be
the Fluoro mode.
Page 14-12

Foot switch HLF mode label
The label is located on the foot
44 1 switch. If the button is pressed, the
right side’s exposure mode will be
the HLF mode.
Monitor spring arm warning label

The label is located on the
monitor’s spring arm. It reminds the
45 1 operator to use handles to move
the monitor, and to avoid contact
with the C-arm. Otherwise, this may
cause the damage to the system, or
harm the patient, or the operator.
Horizontal cross arm left scale
The label, located on the horizontal
46 1 cross arm, is used to help the
operator locate the horizontal cross
arm position of the C-arm.
Horizontal cross arm right scale
The label, located on the horizontal
47 1 cross arm, is used to help the
operator locate the horizontal cross
arm position of the C-arm.
Lateral rotation moving scale
The label, located next to lateral
48 1 rotation moving brake handle, is
used to help the operator locate the
lateral rotation position of the
C-arm.
Horizontal wig-wag scale
The label, located next to horizontal
49 1 Wig-Wag brake handle, is used to
help the operator locate the
horizontal Wig-Wag position of the
C-arm.
Horizontal wig-wag arrow
The label, located below horizontal
50 1 Wig-wag scale, is used to indicate
the horizontal wig-wag scale’s
0-point position.
Page 14-13
Labels and Symbols

Horizontal cross arm arrow
The label, located below horizontal
cross arm left scale and horizontal
51 2 cross arm right scale, is used to
indicate the horizontal cross arm
scale’s 0-point position.
Lateral rotation arrow

The label, located below lateral
rotation moving scale, is used to
52 1 indicate the lateral rotation moving
scale’s 0-point position.
Orbital Rotation Arrow Mark (Left)

This label locates at the left side of
53 1 orbital rotation moving scale, is
used in pairs with the orbital
rotation moving scale to indicate
the 0-poisition.
Orbital Rotation Arrow Mark (Right)
This label locates at the right side of
54 1 orbital rotation moving scale, is
used in pairs with the orbital
rotation moving scale to indicate
the 0-poisition.
Wireless device tag
This tag is located next to the
wireless network switch to indicate
55 1
the location of the wireless network
switch.
Patient Orientation Label

This label locates at the Image
56 1 intensifier, which is used to indicate
the patient orientation
corresponding to the upside of the
displayed image on monitor.
Page 14-14

Swing Arm Indication Label
This Label indicate the location of
swing arm brake handle. Rotate the
handle to released position (lock is
57 1 open) can unlock the Swing Arm
movement. Rotate the handle to
Locked position (lock is closed) can
brake the Swing Arm movement.
Unique Device Identifier (UDI).

Every medical device has a unique
marking for identification. It is
attached on the mainframe base
cover.
Note that this is only an example of
a UDI marking.
The characters used in the UDI
marking represent specific
identifiers.
Device identifier:
⚫ (01) = GS1 global trade item
58 1 number (GTIN) of the device.
⚫ 00840682125604 = Global
trade item number.
Production identifiers:
⚫ (11) = GS1 application identifier
for the manufacturing date of
the device.
⚫ 161200= Manufacturing date:
year-month-day (YYMMDD)
with DD always equal to 00.
⚫ (21) = GS1 application identifier
for the serial number of the
device.
BB6SS1600000HL = Serial number.
This product is in conformity with
performance standards for
fluoroscopic equipment
59 1 under 21CFR 1020.32, except with
respect to those characteristics
authorized by
Variance Number 2018-V-0624
effective March 15, 2018.
Page 14-15
Labels and Symbols
14.2.2. Locations of the Labels
Page 14-16
Page 14-17
Labels and Symbols
14.3. Symbols
Be familiar with the following symbols that may appear on equipment and schematics, so you can safely
maintain and operate the system:
Item name Symbol Description
1 Dangerous voltage This symbol identifies
areas where hazardous
voltages may be present.
Use appropriate safety
precautions.
2 Refer to the manual The symbol identifies that
the operator should read
the manual carefully
before finishing the
operation.
3 Safety warning The symbol identifies that

improper operation may
cause safety risk here.
4 This symbol identifies an

earth ground connection
Earth Ground
that is necessary to
Connection
maintain grounding
throughout the system.
5 This symbol means that
Ionization Radiation there is ionization
radiation.
Page 14-18
Chapter 15. Technical Reference
Technical Reference
15.1. Overview
The policy of GE Healthcare is one of continuous product development and improvement.
For this reason, GE Healthcare reserves the right to change the operating characteristics and specifications
of newer products at any time, without prior notice, and without incurring any obligation relating to
previously manufactured items.
The specifications listed are limited to general performance and physical data. Specifications of optional
equipment provided by other manufacturers are given in the applicable manuals provided with those
options.
15.2. System Specifications

15.2.1. Classification Type
• Class I equipment (as defined by IEC60601-1)
• Type B protection against electric shock (IEC60601-1)
• Ordinary protection against ingress of water
Degree of Protection:
System: IPX0
Footswitch: IPX8
• Operation Mode:
Continuous operation
• Loading Mode:
Intermittent loading
15.2.2. Environmental Requirements

Operating Conditions:
Temperature: +10°C~+40°C (+50F~+104F)
Humidity: 20%~80% Relative, non-condensing
Atmospheric Pressure: 660hPa~1060hPa
Transportation and Storage:
Temperature: -20°C ~+55°C (-4F~+131F)
Humidity: 10%~95% Relative, non-condensing
Atmospheric Pressure: 500hPa~1060hPa
Page 15-2
15.2.3. Power Requirements

Voltage: AC 100V/110V/120V|200V|220V/230V/240V +/-10%
Frequency: 50Hz/60Hz
Rated Momentary Line Current (shorter than 5s):
• 30A (100V/110V/120V)
• 28A (200V)
• 25A (220V/230V/240V)
Rated Continuous Line Current:
• 20A (100V/110V/120V)
• 12A (200V)
• 10A (220V/230V/240V)
Maximum line impedance: 0.3  |0.6  |0.6 
Maximum line voltage regulation(Percent): 15% at maximum radiographic exposure.
Line voltage regulation means difference between measurement made at the input (primary winding) of
the isolation transformer under standby conditions and measurement at maximum radiographic exposure,
expressed as a percent of measurement at maximum radiographic exposure as the following equation:
Percent line voltage regulation = 100 (Vn - V1)/V1
Where Vn = no load voltage (standby), and V1 = loaded voltage (maximum radiographic exposure).
Technique factors that constitute the maximum line current condition is 110kV, 20mA.
Page 15-3
Technical Reference
15.2.4. Physical Specifications
Page 15-4
SID (Source Image Distance) 39.4’’ (100cm)

Horizontal travel 7.9’’ (20cm)
Vertical travel 17.5’’ (45cm, rounded)
Orbital rotation 120°(90°underscan /30°overscan)
Lateral rotation 410˚(+205˚/-205˚)
Wig-Wag 25˚(+12.5˚/-12.5˚)
Weight 310±10kg
15.3. Specification of Key Components

15.3.1. X-ray Generator
• Nominal electric power:
2.0kW (100kV, 20mA, 0.1s)
• Maximum electric power:
Normal Fluoro 440W (110kV, 4mA)
High Level Fluoro 660W (110kV, 6mA; 55kV, 12mA)
Low Dose 220W (110kV, 2mA)
Digital Spot 2.2 kW (110kV, 20mA) @ 200V, 220V, 230V, 240V;
1.1 kW (110kV, 10mA) @ 100V, 110V, 120V
Film 2.2 kW (110kV, 20mA) @ 200V, 220V, 230V, 240V;
1.1 kW (110kV, 10mA) @ 100V, 110V, 120V
• High frequency generator: 40kHz
• Voltage: 40kV~110kV
Normal Fluoro When the X-ray tube current reaches its highest value of 4mA, the
obtainable highest X-ray tube voltage is 110kV.
High Level Fluoro When the X-ray tube current reaches its highest value of 12mA, the
Low Dose When the X-ray tube current reaches its highest value of 2mA, the
Digital Spot When the X-ray tube current reaches its highest value of 20mA, the
obtainable highest X-ray tube voltage is 110kV @ 200V, 220V, 230V, 240V.
When the X-ray tube current reaches its highest value of 10mA, the
obtainable highest X-ray tube voltage is 110kV @ 100V, 110V, 120V.
Film 20mA, stationary @ 200V, 220V, 230V, 240V, the obtainable highest X-ray
tube voltage is 110kV;
10mA, stationary @ 100V, 110V, 120V, the obtainable highest X-ray tube
voltage is 110kV.
Page 15-5
Technical Reference
• Current:
Normal Fluoro 0.1 mA~4 mA; when the X-ray tube voltage reaches its highest value of
110kV, the obtainable highest X-ray tube current is 4mA.
High Level Fluoro 0.2 mA~12 mA; when the X-ray tube voltage reaches its highest value of
Low Dose 0.1 mA~2 mA; when the X-ray tube voltage reaches its highest value of
Digital Spot 0.2 mA~20 mA; when the X-ray tube voltage reaches its highest value of
110kV, the obtainable highest X-ray tube current is 20mA @ 200V, 220V,
230V, 240V.
0.2 mA~10 mA; when the X-ray tube voltage reaches its highest value of
120V.
Film 1mAs~80mAs @ 200V, 220V, 230V, 240V; current: 20mA, stationary; the
obtainable highest X-ray tube voltage is 110kV;
1mAs~40mAs @ 100V, 110V, 120V; current: 10mA, stationary; the
• Film:
Voltage: 40~110kV;
mAs: 1.0, 1.3, 1.6, 2.0, 2.5, 3.2, 4.0, 5.0, 6.3, 8.0, 10, 13, 16, 20, 25, 32, 40, 50, 63, 80 mAs @ 200V, 220V,
230V, 240V;
mAs: 1.0, 1.3, 1.6, 2.0, 2.5, 3.2, 4.0, 5.0, 6.3, 8.0, 10, 13, 16, 20, 25, 32, 40 mAs @ 100V, 110V, 120V.
• Pulse Fluoro: 1/2/4/8pps
• The lowest Current Time Product or the combination of Loading Factors: 40kVp, 1mAs.
• Film Mode Duty Cycle:
110 kVp @ 20 mA, 4 seconds (80 mAs)
Once per 5 min (1.3%) continuous
Once per 2min (3.3%) for 10 exposures
• kVp Accuracy 7%
• mA Accuracy 10%
• mAs Accuracy 10% + 0.2mAs
• Film mode linearity < 0.18
• Reproducibility Coefficient of Variation (COV) < 0.045
• Measurement Basis for Technique Factors
Page 15-6
kVp - The peak value of high voltage generator output in the interval after a 20 ms delay period to the
end of the exposure.
mA - The time average of the current flow into the high voltage cable/X-ray tube assembly, at
beginning the point where kVp crosses the 35 kVp level.
Time - Measurement of exposure time begins when the kVp crosses the 35 kVp level (80% of kVp
selected).
mAs - The time integral of mA as defined above.
Page 15-7
Technical Reference
15.3.2. X-ray Source Assembly

Inherent filter 2.55 mm Al @50KV
Maximum continuous heat dissipation rate 177W
Tube assembly dimension (length X Width X Height) 327mm X 132 mm X 238 mm
Tube assembly weight 17.5 kg
Maximum heat capacity 900,000HU
Maximum cooling rate 12,500HU/min
Cooling method Natural cooling
Maximum symmetrical radiation field on the X-axis 100cm from the spot:
Fluoro: 235 mm (diameter)
Film: 240mm (diameter)
Max. uninterrupted fluoro time (70KV/4.3mA, 8PPS) > 1hr30min at 300W
Leakage radiation Dose rate is less than 0.88mGy/h, averaged
over any area of 100 cm2 of which no principal
linear dimension exceeds 20 cm at 1 m from
the focal spot under conditions of loading.
Leakage radiation test condition 110 kV, 2mA
Reference axis
Location of the focal spot and the reference axis

Focal spot
The reference axis is from the center of the

focal spot to the center of the image
intensifier. Focal spot’s tolerances on the
reference axis is zero.
Page 15-8
X-ray tube
Nominal high voltage 110 kV
Nominal input power 2.2 kW
Maximum anode heat capacity 53 kJ
Target material Tungsten
Target angle 10°
Small focal spot (Normal Fluoro, High Level Fluoro, 0.6×1.4 (IEC336)
Digital Spot)
Large focal spot (Radiography, Digital Spot) 1.4 (IEC336)
Anode Stationary
Typical filament specification 4.2V, 3.5A
Maximum filament current 4.6A
Permanent filtration 0.55mm Al @50kV
Weight 0.65 kg
Manufacturer and model Lohmann, 110/3 DF;
Hangzhou Kailong Medical
Instruments Co., Ltd.,
KL188SBR-0.6/1.2-125
Maximum voltage between anode and ground 55kV
Maximum voltage between cathode and ground -55kV
X-ray radiation angle 10°
Bracket (between the tube assembly and the collimator)
Filter 0.8 mm Al
Collimator
Filtration 0 mm Al
Input power DC 5V, 1W
Electrical connection mode Through 3mm, 12pins connector
Mechanical connection mode Bracket, screw fitting
Iris collimator
Fluoroscopy nominal diameter: 23/16/12cm (9”/6”/4.5”)
X-ray beam continuously adjustable to an area of less than 5 X 5 cm at the image receptor
Film nominal diameter circle: 23cm (9”)
Shutter collimator
Full range rotation angle: 360°
Operation: by TechView tablet (control panel)
Page 15-9
Technical Reference
The total filtration

3.35 mm Al without removable filter (Removable filter: 3.5 mm Al)
15.3.3. Others
Grid
Type Circular
Focus distance 100 cm
Monitor
Type Widescreen with touchscreen
Size 27’’
Resolution 1920X1280
Image Intensifier
Input field size 9’’(23 cm) 6’’(16cm) 4.5’’(12cm)
Central resolution 52Lp/cm 58Lp/cm 68Lp/cm
Image Storage
Capacity 100,000 images
Image resolution 1K x 1K
Digital Processor
Function Negate, edge enhancement, Auto

Brightness/Contrast, manual Brightness/Contrast
adjustment, rotation/reversal/invert, smart metal,
zoom/roam, swap, recursive noise reduction and last
image hold
Fuse
Reference Position Technical reference

F3,F4,F5,F7,F8 Mother Board 1.25A,250V,Fast Acting
F1,F2,F6 Mother Board 2.5A,250V,Fast Acting
F6,F8 Power Management Unit 0.5A,250V,Time Delay
F2 System Interface Board 1A,250V,Time Delay
F1 System Interface Board 3.15A,250V,Time Delay
Page 15-10
15.4. Tube Rating Chart

The following charts and data describe tube characteristics when operated with three-phase full-wave
rectification, a reasonable approximation to the high frequency generator with minimal ripple.
15.4.1. Filament Emission Characteristics

Small Focal Spot
Large Focal Spot
Page 15-11
Technical Reference
15.4.2. Single Load Ratings

Small Focal Spot
Large Focal Spot
Page 15-12
15.5. Tube Thermal Characteristic

Anode Heating and Cooling Characteristic:
Oil temperature 40°C
Tube Housing Heating and Cooling Characteristic:

Tube Housing Heating and Cooling Characteristics
HU 300W 200W
800 000
640 000
480 000
320 000
160 000
0
0 25 50 75 100
Time (minutes)
Page 15-13
Technical Reference
15.6. Room Interface (RIF)

Room Interface (RIF) is an interface interactive with an operation room or some peripheral equipment. The
lamps in operation rooms such as Room In Use indicator or X-ray On indicator can be connected to system
to warn user, injector can be controlled by room interface if necessary, also the exposure can be limited by
door status in case of excessive radiation to user, all functions in RIF are not mandatory when being
operated.
System provides a HDB15 connector as room interface output/Input to connect each indicators.
For Room Interface (RIF) connection, the rules listed below must be complied with:
1. All equipment and power connected to RIF must be UL/IEC60601 certified.
Power
V < 36VDC
I ＜ 2A
2. For “Room in Use Indicator”, the power
Room in Use
Pin _ 3 Indicator
should be less than DC 36V, and current

should be limited within 2A. The connection Relay Switch
diagram is shown on the right.
Pin _ 8 R
Power
V < 36VDC
I ＜ 2A
3. For “X-ray on Indicator”, the power should Pin _ 2
Xray on
Indicator
be less than DC 36V, and current should be
limited within 2A. The connection diagram
is shown on the right.
Relay Switch
Pin _ 7 R
4. For “Injector in Use Indicator”, the power Power

V < 36VDC
should be less than DC 36V, and current Pin _ 1
I ＜ 2A
should be limited within 2A. The connection

diagram is shown on the right.
Relay Switch Injector
Pin _ 6 R
5. For “Door Open Detector”, a rated 24VAC is

Door Switch
needed to drive an AC relay in internal Pin _ 4
circuit, the door switch status will be
detected by system. The connection AC Relay
diagram is shown on the right. Coil
Power
V = 24VAC
Pin _ 5
Page 15-14
15.7. Options and Accessories

15.7.1. Wireless Module
The system provides optional wireless means to connect to the Ethernet network with Wireless module.
The Wireless module works as a client device in OEC One, connecting to the hospital image archive server
or other RIS servers such as work list server by an access point device, or a router device which is provided
by hospital IT infrastructure. Other wireless client devices such as cellphone or laptop can’t be connected to
OEC One. The wireless technology used in OEC One is not used for transmission, reception, or process
involving alarm signals.
When using the wireless network, open the Wireless module on rear panel by wireless power switch, then
setup the wireless network. For detailed setup information, please refer to section “DICOM Setup”.
ON
OFF
Wireless power switch
The Wireless Module comply with following countries regulations but not limited:
1) Wireless Module compliances with FCC requirements for operating in the United States and has
been tested and complies with the specifications for a Class B digital device, pursuant to Part 15
Subpart B of the FCC Rules
2) Wireless Module compliances with Canadian Department of Communication Radio Interference
Regulations ICES-003 and RSS-247.
3) Wireless Module compliances with Regulations of State Radio Regulatory Commission of the
People’s Republic of China.
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Technical Reference
4) Wireless Module shall be compliance with the Essential Requirements and other relevant provisions
of Directive 2014/53/EU.
5) Wireless Module compliances with the Australia and New Zealand RCM certification.
6) Wireless Module compliances with Broadcasting and Communication Equipments of South Korea.
7) Wireless Module compliances with Certification of Radio Equipment in JAPAN.
8) Wireless Module compliances with Certification of Radio Equipment in Taiwan.
Technical Specifications:
Feature Description
Antenna 2 antennas
Standards 802.11a, 802.11n, 802.11g, or 802.11b
Radio data rate Auto Rate Sensing
Operating frequency FCC: 2.412 to 2.462 GHz (11 channels)
ranges – 2.4GHz CE: 2.412 to 2.472 GHz (13 channels)
FCC:
5.180 to 5.240 GHz (4 channels)
5.500 to 5.700 GHz ( 8 channels, excluding 5.600
Operating frequency to 5.640 GHz)
ranges – 5 GHz 5.745 to 5.825 GHz (5 channels)
CE:
Power 12V,0.56A
Emissions FCC, CE
LAN 10/100/1000BaseT(X) auto negotiation speed, RJ-45
Operating environment Operating temperature: 0 to 60°C
64-bit and 128-bit WEP encryption,
WPA/WPA2-Personal
Encryption
WPA/WPA2-Enterprise (IEEE 802.1X/RADIUS, TKIP, and
AES)
Quality of Service (QoS) WiFI Multi-media (WMM)
Page 15-16
To join a wireless network, select network name (also called the SSID) and enter correct user name and
passphrase. If the Wireless Module cannot connect to the network, the following information will display on
user interface: (SSID) Disconnected.
In this case, please try following trouble shooting methods to attempt to reconnect network:
• The user name and passphrase is case-sensitive, please confirm and retype the user name and
passphrase.
• Make sure the wireless module power switch is at “On” position.
• Make sure the router is turned on.
• Adjust system position.
• Use one greater wireless range router.
• Use a range extender to extend its wireless range to your location.
Separation distance of 20 cm or more should be maintained between this device and
NOTE persons during device operation. To ensure compliance, operations at closer than this
distance is not recommended. The antenna used for this transmitter must not be co-located
in conjunction with any other antenna or transmitter.
15.7.2. 30cm Skin Spacer

Skin spacer is used to increase the distance of skin to X-ray focal spot, it can decrease the over radiation
risk.
The weight of Skin Spacer: 0.35±0.1kg. Skin spacer can be installed on the tube cover and removable filter.
Install the skin spacer using the following steps:
1. Put the skin spacer on the X-ray tube cover or removable filter. Make sure the skin spacer’s hole
superpose with the screws.
2. Rotate the skin spacer clockwise to lock it onto the cover.
Page 15-17
Technical Reference
15.7.3. Removable Grid

In some countries or regions, a removable grid is required to be used in pediatric or other medical
applications. Please use this option as requirement of local regulations. When user is conducting imaging
without a removable grid, system can obtain images with lower dose, but it may cause image blurring,
image quality may be sub-standard.
Removable Grid Installation:

First, press the localizer bolt button, remove the bolt from the handle, and rotate the handle.
Install the removable grid on the image intensifier, and pay careful attention when installing the
localizer bolt, it should be located inside the grid holder.
Rotate the handle to lock the filter support, and insert the localizer bolt.
Removable Grid Uninstallation:

First, press the localizer bolt button, and remove the bolt from the handle, rotate the handle. Remove
the removable grid from the image intensifier.
15.7.4. Removable Filter

In some countries or regions, removable filter is required to be used in pediatric or other medical
procedures. Please use this option as requirement of local regulations. Using the removable filter, will
reduce the dose radiation for the patient and technician. For the same parts imaging, the kVp and mA may
increase and tube sustainable exposure time may be shortened.
The removable filter includes two sensors and a 3.5 mm Al filter. The weight of the filter is 0.3±0.1kg.
Page 15-18
15.7.5. Video Distributor

The video distributor provides a means to view the image on a monitor on an external monitor. System
video distributor weight: 0.6 ± 0.05kg.
The system exports the image on the monitor or the left area of the image on the monitor to the
external display device via the video distributor.
The system video distributor provides DVI-I and BNC interfaces for external display devices.
The system video distributor outputs a DVI-D video signal with a resolution of 1920x1080 (16: 9) and a
refresh rate of 60Hz through the DVI-I interface. External display devices are recommended to use the
same settings. under normal circumstances, the external display device display the same image. There are
other conditions as below:
If the external display device does not support the above resolution and refresh rate, the image on the
monitor may not be displayed properly.
If the external display device is a VGA interface, you must use a cable with a DVI-D to VGA transceiver,
otherwise the external display device will not be able to display the image on the monitor.
If the external display device supports the above resolution and refresh rate but it is not the
non-widescreen display device, the image will be compressed on the horizontal axis.
The system video distributor can output the left area video signal of the image on the monitor to the
external display device by NTSC / PAL format. Normally, the image on the external display device will be the
same as the left area of the image on the monitor. The video splitter support “NTSC / PAL" and "16:9/4:3”
video signal output for the external display device, the default setting is PAL/4:3. please call for service to
change the output settings.
15.7.6. Laser Aimer

The laser aiming device produces a laser beam, which is used to indicate the central axis of the X-ray
beam. An opaque cross-hair located on the laser aimer provides a reference point in the X-Ray image that
can be used in conjunction with the laser beam to obtain an accurate placement angle during alignment
procedures.
OEC One C-arm Mobile C-arm X-ray Product provides two laser aimer options, which are attached to the
tube and image intensifier.
Image intensifier side Laser Aimer Tube side Laser Aimer

CLASS IIIa/3R laser product CLASS 1M laser product
Wavelength: 635 nm Wavelength: 637 nm
Optical output power: ≤5.0 mW Optical output power: ≤5.0 mW
Page 15-19
Technical Reference
Laser aimer, which is attached to the tube, is incorporated with the tube cover. Press the laser aimer’s ON
switch to generate the laser beam. The weight of generator’s laser aimer: 0.65±0.05kg.
Perform the following procedure to install and operate the laser aimer on the Image Intensifier. The C-arm
can be placed in any orientation that is convenient for attaching the laser aimer. There are no alignment
marks or notches on the laser aimer that need to match any points on the image intensifier. The weight of
the laser aimer on the image intensifier: 2.15±0.2kg.
When the laser aimer is attached to the C-arm, releasing the orbital or rotational brake could
cause the C-arm to move. Make sure to hold the C-arm to control its movement whenever a
brake is released.
1. Place the laser aimer’s attachment handle in the open position.

2. Move the laser aimer flush with the Image Intensifier, but slightly off center.
3. Center the laser aimer with the relation to the Image Intensifier. As you center the laser aimer, the
attachment hooks catch on the edge of the image intensifier.
4. Turn the attachment handle inward until the handle is completely closed and the laser aimer is
securely attached to the image intensifier. Insert the metal bolt into the hole of the handle to lock.
Page 15-20
Do not grasp the Laser Aimer's handle to position the C-arm or to move the system. Pulling
the handle may cause the Laser Aimer to release from the image intensifier and fall.
5. Use the image intensifier handle to position the C-arm or to move the system to the desired location.
6. After attaching the laser aimer, place the C-arm in the position it will be used during the procedure.
7. Turn the laser aimer ON and adjust the beam alignment knobs until the laser beam is centered on
the crossing of the cross-hairs on the tube cover.
If the laser is ON, do not look directly into the laser aimer’s aperture.
8. Using fluoroscopy, position the cross-hairs in the Fluoro image, at the center of the area of interest.
The location where the laser beam marks the patient corresponds to the center of the area of
interest, indicated by the cross-hairs in the Fluoro image.
If you don’t want the cross hairs to show on the image, remove the laser cover from the laser aimer.
1. Switch OFF the power to the laser aimer.

2. Grasp the two knobs on the laser cover.
3. Press down and rotate the cover (approximately 10 degrees counterclockwise) until the knobs align
with the notches on the housing.
4. Lift off the cover and resume laser aimer operation.
Regardless of efforts taken when using this device, attempts to adjust or operate the
equipment may result in harmful radiation.
Page 15-21
Technical Reference
15.7.7. Film Cassette Holder

The film cassette holder is used to hold the film cassette to get the film image in film mode.
Film cassette holder dimension: 33.1cm x35.0cm x5.2cm for 9’’ Image Intensifier. The weight of the
film cassette holder: 1.35±0.1kg.
Film cassette dimensions: 10’’ x 12’' (24 cm x 30cm) for 9’’ image intensifier.
If user needs to install the film cassette holder, please make sure the lock handle is locked into place.
15.8. Material Recycling

Parts or accessories at end–of–life:
All materials and components that could have risks to the environment must be removed from the
end-of-life parts and accessories (For example: transformer oil, batteries, etc). The disposing of parts and
accessories must be in accordance with national or local regulations for waste processing.
Please consult your local GEMS representative before discarding these products.
Packing materials:
The materials used to pack our equipment are recycled. They must be collected and processed in
accordance with the local regulations.
Page 15-22
15.9. Replacement Parts

Parts as listed can be replaced in the field. Call service to replace or maintain these parts.
• Circuit boards
• Cables
• Collimator
• Image intensifier
• Camera
• Monoblock
• DC power supply, fuse, capacitor, filters, breaker and fuse
• Power on indicator and exposure indicator
• Monitor and TechView tablet (control panel)
• Memory bank, mother board assembly, hard disk of computer
• Footswitch, hand switch and emergency switch
• Handles and wheels
• Covers
• Transformer
• Batteries
Never make any modifications or adjustments to the equipment unless directed by a GE

WARNING Healthcare authorized service engineer.
Page 15-23
Technical Reference
15.10. System Block
Monoblock X-ray Generator Driver
Collimator
Exposure Indicator
Removable Filter
laser Foot/Hand Switch
System Control
Key Switch
laser
Emergency Switch
Grid
Image
Intensifie
r
Backup Battery
Computer Power Management Unit AC Line

10.1" Tablet
Touch Screen
Wireless
DVI Spliter System Interface Board
module
27" Monitor
Wireless
DVI BNC 2 USBs RIF ETH
Touch Screen Button
Interface panel
Page 15-24
Chapter 16. Privacy and Security
Privacy and Security
The following information provides a comprehensive overview of the cyber security considerations for the
OEC One software. Cyber security includes the core concerns of Privacy and Security. Privacy is the property
of protecting the personal private interests of patients. Security protects both the product and the
information from risks to confidentiality, integrity, and availability.
16.1. Privacy and Security Environment

The GE Healthcare OEC One has been designed with the Privacy and Security protections are included in the
environment where this product will be used.
Communication between the OEC One and other information providers takes the form of data flows. Each
dataflow defines the transfer of patient information, DICOM images and system configuration from an input
source to the unit, and from the unit to one of several output sources.
Network Connectivity
Network connection for OEC One is required by below system feature:
• DICOM connectivity to other DICOM devices
Network Interconnections
The OEC One network interconnections diagram is shown in Figure below. Being a standalone medical
device, it does not require network connectivity for clinical use. The OEC One does support wired and
wireless Digital Imaging and Communications in Medicine (DICOM) communications to improve the
workflow and connectivity.
Page 16-2
OEC One Mobile C-Arm X-Ray Product
16.2. Privacy and Security Capabilities

The OEC One system incorporates a broad assortment of capabilities to enable Privacy and Security. The
following sections describe the engineering controls provided by the OEC One which comprehensively
“harden” the system against threats.
Access Controls
The access control features may be used to help control access to sensitive information.
Access control includes user account creation and multi-level authentication.
Password Authentication
The OEC One automatically boots to run the clinical application as a single user. In emergency and trauma
environments, clinical and patient needs often outweigh the advantages of providing user authentication.
Therefore, the system may be configured by the user with or without a password depending on preference
and clinical use.
All passwords entered the OEC One are displayed as asterisks, mitigating the risk of unauthorized users
copying passwords. If a password is entered incorrectly the user is not authenticated and the system will not
perform any clinical imaging functions. The system is initially configured with a default administrator account
and password to login into to the clinical application. It is recommended that the customer change the
default OEC One Administrator’s password upon installation and create new user account with password.
The customer password can be changed any time based on the customer’s security policies (e.g. passwords
changed annually). Passwords are case sensitive with a minimum length of 4 characters and a maximum of
10. To reset user account and password, an administrator account is required to login the clinical application.
To reset the administrator password, service users are required to login to the system with elevated
privileges.
Multi-Level Authentication
This access control system provides multi-level system permissions based on user type. Each level of access
is authenticated using a unique password entered system in service mode. Multi-leveled user roles limit the
ability of general medical staff to tamper with or accidently misconfigure the system. Higher level access
roles should be restricted by the customer through control of passwords to ensure only trained and trusted
staffs have access to these roles. It should be noted that the OEC One does not support remote login for these
users.
Emergency Access to the System

The OEC One system has an emergency mode that makes the system available for performing taking
exposure in emergency situations. This is especially important in emergency situations as the normal staff
may not be available. The emergency mode recognizes that patient care is more important than limiting
access to patient data. No authentication is needed for using the system in emergency mode.
Page 16-3
Service Access
Service Access provides the service engineer with access to the system, including modification the system
configuration.
Audit Logging
Privacy and Security audit logging supports security surveillance and Privacy investigations and reporting.
The system provides integrated functionality for audit logging, including audit logging of privacy related
events. The audit log functionality includes the ability to export the logged events from the system.
System Audit Information

Secure computer generated time-stamped electronic records that allow reconstruction of the course of
events relating to the creation, modification, and deletion of electronic records and system files is an
important aspect of a secure design. A large number of system events related to privacy and security are
logged as part of the system operation.
16.3. Information Protection

This section focuses on Privacy and Security operations, and contains information to guide in the preparation
of a secure environment for the OEC One system. Security operations are best implemented as part of an
overall “defense in depth” information assurance strategy used throughout an Information Technology
system that addresses personnel, physical security and technology. The layered approach of defense in
depth limits the risk that the failure of a single security safeguard will allow compromise of the system.
Network Security
GE strongly recommends that medical information systems are operated in a secure network environment
that is protected from unauthorized intrusion. There are many effective techniques for isolating and
protecting medical information systems, including implementing firewall protection, demilitarized zones
(DMZs), Virtual Local Area Networks (VLANs) and network enclaves.
For example, a best practice is to place firewalls between departments, as well as at a DMZ (Demilitarized
Zone) between all extranets, and the external internet access point. In this example, a radiology firewall may
allow DICOM and HL7 protocol traffic through, but no other protocols. These DICOM and HL7 protocols would
be blocked at the DMZ and again at the internet firewall.
Although the OEC One is a standalone system that does not require any network connections to operate
network, security is vital to continued safe and effective operation of the system. The OEC One uses a
defense-in-depth approach protecting the system from unauthorized access via the network. This layered
approach leverages network isolation, software segregation, and wireless security controls.
All unnecessary network related services are disabled or removed when OEC One installed. For example, The
OEC One does not support remote service connections. Additionally, the OEC One restrict the embedded web
browsers to browse any external web sites and it does not allow any browsers to be installed. These
applications are often the source of cyber threats.
Page 16-4
To assist in secure network design, the following network profile outlines the required network services for
the system.
OEC One is supported with internal firewalls. The following sections describe configuration of the firewalls,
and guidance for configuring the IT infrastructure where it is connected.
Inbound Firewall Configuration – OEC One

All inbound connections are blocked by the OEC One system’s internal firewall, with the
exemptions listed in the table below.
The column “Recommended configuration of network infrastructure” describes the suggested
configuration of the network infrastructure regarding the different network services.
Table 1. Inbound firewall Configuration for the OEC One System
Local port Remote Protocol Programs Recommended configuration Network service

port of network infrastructure
68 All UDP All Open to DHCP protocol on the DHCP Client

system
1004 All TCP All Open to DICOM server(s) DICOM Retrieve
configured on the system
SCP
DICOM Connections – Security Capabilities

The DICOM connection works as defined by DICOM guidelines. The application accepts connection only
to/from DICOM entities with IP-address, AE Title and port number matching the configured parameters in the
system.
The communication sessions are on demand, always initiated locally from the system.
Wireless Network Security – Wireless Operation

The OEC One supports wireless network connectivity for DICOM communications. Due to the broadcast
nature of wireless communication, wireless devices require additional security considerations. Encryption
of wireless communication is critical for the confidentiality of the information being transmitted. OEC One
supports the following wireless security protocols:
• WEP (64/128)
• WPA-PSK (AES)
• WPA2-PSK (AES)
• IEEE 802.1X (EAP-PEAP, EAP-TLS, EAP-TTLS)
Page 16-5
Removable Media Security

The OEC One system supports USB storage devices. USB storage devices are used for:
• Exporting patient data and images
• System back-up and export of audit logs
• Exporting/importing system configurations
It is well known that a common source of malware in computing environments is from external media
sources such as USB thumb drives. The OEC One provides the following controls to limit external media
access.
• The OEC One does not permit execution from external media.
• The OEC One does not permit auto-run from external media.
• The OEC One does not permit the ability to boot from external media.
• The OEC One does not permit the ability to boot from the network.
USB Storage
Data stored on USB media is stored unencrypted. While the user has the option when exporting data to de-
identify the data, if the exported data is not de-identified the data could contain personal information (PI).
The USB storage devices and the content on them must be handled according to applicable regulations and
guidelines for handling personal information (PI) / protected health information (PHI).
Data Destruction for Portable Media

The system does not have an internal functionality for secure deletion of data stored on the removable
devices.
Approved procedures and tools should be used for secure removal of data stored on removable media, per
applicable regulations and guidelines for handling patient information / personal information (PI) / protected
health information (PHI).
Data at Rest Security

Back-up
The system stores unencrypted data to the back-up target. This may include PI/PHI. The target for the back-
up, must be secured to ensure the required security of the backed-up data from the system.
External Data Flows

The system supports interconnections to external storage systems. This includes connections to DICOM
servers. The data stored on the interconnected system must be secured on the external storage system
(outside the scope of the system).
Page 16-6
Stored Data
Data stored on the system computer is stored unencrypted on the systems file system. This includes patient
information in the database, images, raw data and audit log.
The data stored on the system computer should be secured to prevent unintended access to personal
information (PI) / protected health information (PHI) being part of this data.
Data Integrity Capabilities

The system provides check integrated function for service to ensure the data integrity in the system.
De-Identification Capabilities
The system contains de-identification (anonymization and pseudonymization) capabilities to limit privacy and
security risks to sensitive information. De-identification is done by clearing or overwriting all information in
the image containing PI / PHI. When creating a problem report, the option may be selected.
Business Continuity
To ensure business continuity, several options must be considered related to data storage.
The target for the images and patient archive must be chosen to ensure safe storage of the data. Both
internal and external alternatives are supported.
Patient Archive Solutions

The system supports following alternatives for storing images and patient information, both internally and
externally:
• Local storage: local storage on the system (intended for temporary storage only)
• DICOM storage: storage on DICOM / PACS server
Securing Data on Remote Archive and DICOM/PACS Servers

If an external archive is used, make sure to establish backup procedures for the external archive. The
business contingency planning of data stored on DICOM / PACS servers is outside the scope of this document.
Security Controls provided by the Cloud Provider

The OEC One system does not support the cloud.
Page 16-7
16.4. Syestem Protection

The system must be configured and maintained in a way that continually protects Privacy and Security.
Malicious Software Protection

The computing environment is increasingly hostile, and threats continue to grow from malicious software,
including computer viruses, worms, Trojan horses, denial of service attacks, and other malwares. Vigilant
defense on many levels is required to keep systems free from compromise by malicious software. In most
cases, effective protection requires cooperation and partnership between GE and our customers.
Commercial anti-virus software is commonly used on general-purpose computers to detect the presence of
malicious software (virus, Trojan horse, worm, etc.). Anti-virus software is useful on general-purpose
computers as they typically cannot be sufficiently hardened against the attack vectors used by malicious
software.
The OEC One system however is a single-purpose (dedicated) device with a controlled intended use. For such
system, the functional performance risks introduced by using commercial anti-virus software would
outweigh the security benefits. Such risks include:
• Real-time anti-virus scanning can affect system performance.
• False positive results can be introduced.
• Quarantining of clinical data that appears to match a virus signature.
• The anti-virus software itself is a popular attack vector.
• Disruptive nature of the support of the anti-virus software throughout the life cycle of the medical device.
The operating system of the system is part of a medical device that requires a special and controlled
release process. Any update of the anti-virus software would require a change of the system software.
Due to the cited risks, the use of commercial anti-virus software is not part of the OEC One product security
strategy. In addition, the OEC One’s software is scanned using DoD approved (Nessus) vulnerability detections
tools prior to release.
System Security
The GE Healthcare OEC One contains additional features to improve local operational security.
GE Healthcare Service Access

To access the system in service mode, a service password is required. A GE Healthcare field engineer will
typically be needed to access the system in service mode.
When in service mode, the field engineer will have neither access to the operating system nor to the file
system.
Page 16-8
Screen Saver
The system has a configurable screen saver feature. It can be configured to enter the screen saver after a
predefined time. When enter screen saver, no patient information is visible on the screen. The screen saver
will exit by any operation of user. To minimize impact of clinical operation, no password is required to exit
screen saver.
Screen Blanking
In addition to the logout and screen saver functionality, the system allows the user to blank the screen to
protect any protected health information.
Firewall
See section 16.3.1
Security Update Strategy

GE Healthcare is constantly monitoring for security vulnerabilities applicable for the products. This includes
vulnerabilities in the application software, third party components and the underlying operating system.
Announced vulnerabilities in the operating system or other third party components, are assessed based on
the system’s configuration and use.
When needed, GE Healthcare will make security updates / patches for the products and make these available
to customers. When applicable, these updates will include patches for the operating system and third party
components.
Security Vulnerability Scanning

In addition to the engineered design controls described above GE Healthcare (OEC) relies on a commercial
scanning tool from Tenable software (Nessus) to detect any vulnerabilities on the OEC One. This Department
of Defense approved tool probes all TCP/IP and UDP/IP ports on the OEC One looking for known vulnerabilities
signatures. All relevant critical and high-risk vulnerabilities discovered are mitigated prior to release.
System (Product) Change Management

GE Healthcare is constantly monitoring for security vulnerabilities applicable for the products. This includes
vulnerabilities in the application software, third party components and the underlying operating system.
Announced vulnerabilities in the operating system or other third party components, are assessed based on
the system’s configuration and use.
When needed, GE Healthcare will make security updates / patches for the products and make these available
to customers. When applicable, these updates will include patches for the operating system and third party
components.
For privacy and security concerns regarding GE products, please refer to
http://www.ge.com/security.
Page 16-9
16.5. Personal Information Collected By The

Product
The GE Healthcare OEC One collects the following types of information for the purposes of creating diagnostic
images:
• Patient demographic information
• Personal or protected health information
• Facility information
• Provider information
• Machine data
The GE Healthcare OEC One protects this information by access controls and retains this information until
the user removes it.
The details of all personal information collected by the product and how it is used is described in the DICOM
Conformance Statements and IHE Integration statements. These are found at the following URLs:
http://ge.com/dicom
http://ge.com/ihe
16.6. Additional Privacy and Security

Considerations
The GE Healthcare OEC One has been designed with Privacy and Security functionality integrated into the
core design. However, there exist Privacy and Security residual risks that must be mitigated once the GE
Healthcare OEC One is integrated into the work environment. This section contains some risks that user
should pay attention to.
• If this product is used in an environment where robust authentication methods are an impediment to
clinical workflow, physical access restrictions to the OEC One are encouraged.
• The OEC One stores data beyond the clinical encounter. The user must manually remove data from the
database when it is no longer needed.
• The user is responsible for securing any removable media that is used to store data from the OEC One.
• The customer must also ensure the product is installed and operated in a safe and secure manner.
Page 16-10
SERVICE OFFICES
SERVICE OFFICES
For service issues, contact the service representative or service office in your country.
AMERICAS
UNITED STATES OF AMERICA
GE Medical Systems Headquarters Tel: +1–414–544–3011
3000 North Grandview Blvd.
WAUKESHA, WI 53188
Mail: P.O. Box 414
MILWAUKEE, WI 53201
LATIN AMERICA
GE Medical Systems Tel: +1–305–497–1200
Latin America Headquarters
5101 NW 21st Avenue, Suite 350
FORT LAUDERDALE, FL 33309
USA
ASIA
JAPAN
GE Healthcare Japan
4-7-127, Asahigaoka, Hino-shi, Tokyo 191-8503, JAPAN
p: +81-(0) 120-055-919
f: +81-(0) 426-48-2905
CHINA
GE HUALUN MEDICAL SYSTEMS CO. Ltd.
No 1 Yong Chang North Road, Beijing Economic-Technological Development Zone
Beijing CHINA. P.O.: 100176
Tel: 8610-58068888
Call center: 400-812-8188
KOREA
8F, POBA Gangnam Tower,
343, Hakdong-ro, Gangnam-gu, Seoul,
Korea 135-820
Tel: 82-2-1544-6119
SERVICE OFFICES
ASEAN
1 Maritime Square #13-01 HarbourFront Centre
Singapore 099253
AUSTRALIA AND NEW ZEALAND
GE Healthcare
Parklands Estate, Building 4B
21 South Street, Rydalmere, NSW 2116
T: (61) 2-9846-4000; F: (61) 2-9846-4001
EUROPE
Contact GE Healthcare service representative
European Representative:
Quality Assurance Manager
78530 BUC France
Tel: +33 1 30 70 40 40
Appendix: Operator Manual Supplement

This document provides operator manual supplement only related to the system with serial number of
BB6SV*******HL (* is number varies from 0-9 which represents manufacturing year and sequence number,
there are totally 7 numbers) which indicated in the rating plate. The product with this serial number
provides optional vascular imaging and dynamic recording (cine) function and is not available for film
mode.
U.S. federal law restricts this device to sale by or on the order of a physician, veterinarian, or
CAUTION other designated licensed practitioner as appropriate for its clinical use.
Some of the functions are available based on which configuration you have purchased.
The table below indicates what have been changed in the Operator Manual:
Operator Manual Operator Manual Change Type Reason for Change
Supplement
(Replacement/New)
Overview/Intended Use Intended Use in 1.1 Replacement Introduce vascular
Overview feature and remove
film mode
Overview/Indication for Use Indication for Use in 1.1 Replacement
Overview
Overview/Options and Options and accessories in Replacement Remove film mode
accessories 2.1 General Description
Overview/System essential System essential Replacement Introduce vascular
performance performance in 1.3 feature
Manufacturer’s
Responsibilities
Footswitch Option Footswitch content in 4.4 Replacement Introduce vascular
Footswitch and Hand feature and wireless
Switch footswitch
Dose to Patient Dose to Patient in 1.6 Replacement Introduce vascular
Radiation Exposure feature and update
generator
Exposure Mode Exposure Mode content in Replacement
specification
6.1 Imaging Mode
Imaging Mode List Imaging Mode List in 6.1 Replacement
Imaging Mode
TechView Tablet (Control Add to 4.3 TechView Tablet New content
Panel) (Control Panel)
Vascular Imaging / New content Introduce vascular
feature
Dynamic Recording (Cine) / New content
Export, Import and Retrieve Add to 7.3 Print, Export and New content
Import and 7.4 Retrieve a
performed Exam
A-1
Operator Manual Supplement
Operator Manual Operator Manual Change Type Reason for Change

Supplement
(Replacement/New)
Cine System Setup / New content
Dose Reproducibility and 12.2.7.10 Dose Replacement Remove film mode
mA Linearity Check Reproducibility and mA
linearity Check
X-ray Generator X-ray Generator spec in Replacement Update generator
15.3 Specification of Key specification
Components
Wireless Regulatory 1.2.3. Continued Replacement Introduce Wireless
Information for EU Compliance Footswitch
Wireless Print System 15.7. Options and New content Introduce Wireless
Accessories print system
Overview
Intended Use: The product is intended to provide fluoroscopic and digital spot images of the patient
anatomy, interventional tools/devices, and/or contrast agents during diagnostic, interventional, and
surgical procedures.
Indication for Use: The product is designed to provide fluoroscopic and digital spot images of adult and
pediatric patient populations during diagnostic, interventional, and surgical procedures. Examples of a
clinical application may include: orthopedic, gastrointestinal, endoscopic, urologic, neurologic, vascular,
critical care, and emergency procedures.
Options and accessories:
Wireless module
30cm skin spacer
Removable grid
Removable filter
Video distributor
Laser aimer on the tube
Laser aimer on the image intensifier
Footswitch (footswitch with 5/10 m cable and wireless footswitch)
Wireless print system
System essential performance:
1. Fluoro imaging functionality;
2. Display & Indication of Last Image Hold (LIH) following termination of X-ray exposure;
3. Patient/Image database integrity / Vascular image database integrity;
4. Acceptable fluoroscopic image quality;
5. Maintain X-ray tube voltage accuracy at 10% or lower;
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6. Ensure increment/decrement between two settings is within 50% to 150% of indicated change;
7. Maintain X-ray tube current accuracy at 20% or lower;
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 Dose Rate
Control feature;
11. Provide radiation dose structured report (RDSR) as per IEC/PAS 61910-1:2007.
Footswitch Option
There are 3 kinds of footswitches provided as option: footswitch with 5/10 m cable and wireless footswitch.
Specifications Weight Label
Footswitch with 5m cable 2.5kg±0.5kg
Footswitch with 10m cable 2.9kg±0.5kg
Wireless footswitch Kit 1.4kg±0.5kg
Footswitch with 5/10 m cable Wireless footswitch
Use the Mode switch to toggle through the available imaging modes on the systems.
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Press the mode switch button with the label to switch the exposure mode pair. Press the save
button with label to save the image on the left area of the monitor.
Symbol located on the back of the wireless footswitch, indicates the operator to keep away magnetic
material during operation. Symbol located on the back of the wireless footswitch, identifies that the
operator should read the manual carefully before finishing the operation.
Wireless footswitch includes a remote control wireless footswitch, a wireless receiver, receiver cable,
footswitch holder and receiver holder. The wireless foot switch is powered by the internal batteries, with
the battery indicator and system connection indicator on the upper right side of the pedal. The battery
indicator and system connection indicator will indicate the current charge and system connection status
when used.
The following table describes the colors and states of each light.
Symbol Color / State Description

LEDs in receiver
Green Device is powered on.
Power Internal error.
Red Contact GE Healthcare authorized service engineer for help.
Off Radio connection not established.
Green Radio connection established, footswitch engaged.
Orange Radio connection established, footswitch not engaged.
Green with red pulses Receiver is in configuration mode.

Connect
Red blinking
(slowly) Device is in pairing mode.
Red blinking
Pairing partner has to be confirmed by pressing the button.
(fast)
Red
Not paired with any switching device.
(Battery LED off)
Red System error. Maintenance required.
(Battery LED orange) Contact GE Healthcare authorized service engineer for help.
Off Footswitch offline.
Green > 50% Battery capacity.

Battery
Orange 20%...50% Battery capacity.
Orange blinking
<20% Battery capacity.
(slowly)
Green blinking Battery is charging.
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Orange and Connect

System error detected at startup test. Maintenance required.
LED off even on pedal
Contact GE Healthcare authorized service engineer for help.
actuation
Orange and Connect System error. Maintenance required.

LED red Contact GE Healthcare authorized service engineer for help.
LEDs in wireless footswitch
Off Footswitch in Sleep Mode.

(and Battery LED Off) To reactivate footswitch, press any X-ray switch.
Off
No pairing partner found (receiver out of range, switched off).
(and Battery LED On)
Green Radio connection established, footswitch pressed.
Green blinking
Radio connection established, limited connection quality.
(slowly)
Connect
Green blinking
Footswitch is in advertising mode.
(fast)
Red blinking
Device is in pairing mode.
(slowly)
Green with red pulses Receiver is in configuration mode.
Pairing partner found, waiting for confirmation.

Red blinking
After confirmation of the pairing, the green LED lights up and
(fast)
the switch switches to Sleep Mode (LED = Off).
System error. Maintenance required.

Red
Contact GE Healthcare authorized service engineer for help.
Footswitch in Sleep Mode.
Off
To reactivate footswitch, press any X-ray switch.
Green Battery capacity ˃ 50% ( ˃ 3.75...4.5 V).

Battery
Orange Battery capacity between 20% and 50% (≤ 3.75...3.3 V).
Orange blinking
Battery capacity ˂ 20% (≤ 3.3...3.0 V).
(slowly)
Orange blinking
Battery level below limit value = 5%, ˂ 3.0 V (Deep Sleep Mode).
(fast)
CAUTION When using the Mode Switch, use caution to avoid inadvertently activate the X-Ray by pedal.
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The wireless footswitch’s legal manufacturer:

GE OEC Medical Systems, Inc.
384 Wright Brothers Dr
Salt Lake City, UT 84116 - USA
The wireless footswitch specifications are as below:

Standard/ wireless security Bluetooth LE
Frequency 2.4 GHz
Modulation mode FHSS, GFSK
Band width 175 KHz
Channel spacing 2MHz
Operating rating Max: 7 dBm
Data rate 1 Mbps
Set up time < 200 ms
Wireless network mode Point-to-point connection
System anti-interference Frequency hopping
Emissions FCC, IC
Distance 8 m (in free air)
Frequency Range 2402 – 2480 MHz
The security management of the wireless footswitch is to analyze unauthorized access to the wireless
device. The device is protected against unauthorized wireless access because the wireless footswitch is
designed to be not interoperable with other systems. The wireless communication procedure is not
published. Monitoring or disturbing is not possible without the intimate knowledge of the proprietary
design.
The data is secured by a checksum that is generated over the user data. A further checksum is generated
by the wireless signal and compared at the module. The lost, corrupted, or time-delayed transmissions and
degradations in wireless transmissions are prevented.
FCC Regulatory Information
The Federal Communication Commission Radio Frequency Interference Statement includes the following
paragraph. This equipment has been tested and found to comply with the limits pursuant to Part 15 of the
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FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a
residential installation. This equipment generates, uses and radiates radio frequency energy and, if not
installed and used in accordance with the instructions, may cause harmful interference to radio
communication. However, there is no guarantee that interference will not occur in a particular installation.
If this equipment does cause harmful interference to radio or television reception, which can be determined
by turning the equipment off and on, the user is encouraged to try to correct the interference by one or
more of the following measures:
- Reorient or relocate the receiving antenna.
- Increase the separation between the equipment and receiver.
- Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
- Consult the dealer or an experienced radio / TV technician for help.
The effective operation distance may be affected by the environment, including the physical
NOTE obstacles between the wireless foot switch and the receiver.
If this Wireless footswitch to be operated within proximity of other wireless devices, the following tables
may be used to determine the minimum separation distances between this device and nearby transmitters.
Exploratory Radiated Immunity (80MHz-6000MHz Exploratory Radiated Immunity Proximity Fields

excluding in band)
Nearby Transmitter’s Minimum Separation (m) Nearby Transmitter’s Minimum Separation (m)
EIRP (W) EIRP (W)
10 0.95 10 0.95
1 0.30 1 0.30
0.1 0.09 0.1 0.09
0.01 0.03 0.01 0.03
Band-Specific Interference: Bluetooth Co-Channel Band-Specific Interference: Bluetooth 2.4GHz Band

(2437MHz) Adjacent-Channel
Nearby Transmitter’s Minimum Separation (m) Nearby Transmitter’s Minimum Separation (m)
EIRP (W) EIRP (W)
10 0.87 10 0.26
1 0.27 1 0.08
0.1 0.09 0.1 0.03
0.01 0.03 0.01 0.01
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Dose to Patient
Without Filter, With Grid With Filter, Without Grid
Imaging Mode Auto Auto
Max Max
(20cm PMMA) (20cm PMMA)
Field Size 9” 6” 4.5” 9” 6” 4.5”
kVp/mA 81/2.1 83/3.2 85/4.0 110/4.0 71/1.7 74/2.5 77/3.9 110/4.0
Continuous
AKR(mGy/min) 10.51 16.61 22.05 38.11 2.44 4.06 7.08 20.70
kVp/mA 82/2.2 84/3.3 87/4.0 110/4.0 72/1.7 75/2.6 78/4.0 110/4.0
12pps
AKR(mGy/min) 7.33 11.49 14.91 25.16 1.66 2.78 4.54 12.42
kVp/mA 82/2.2 84/3.3 87/4.0 110/4.0 72/1.7 75/2.6 78/4.0 110/4.0
8pps
AKR(mGy/min) 4.84 7.67 9.75 16.49 1.11 1.85 3.03 8.28
Normal
kVp/mA 82/2.2 84/3.3 87/4.0 110/4.0 72/1.7 75/2.6 78/4.0 110/4.0
4pps
AKR(mGy/min) 2.48 3.89 5.12 8.48 0.58 0.97 1.56 4.17
kVp/mA 82/2.2 84/3.3 87/4.0 110/4.0 72/1.7 75/2.6 78/4.0 110/4.0
2pps
AKR(mGy/min) 1.24 2.01 2.67 4.34 0.30 0.51 0.81 2.09
kVp/mA 82/2.2 84/3.3 87/4.0 110/4.0 72/1.7 75/2.6 78/4.0 110/4.0
1pps
AKR(mGy/min) 0.625 0.968 1.294 2.125 0.147 0.245 0.399 1.031
Field Size 9” 6” 4.5” 9” 6” 4.5”
kVp/mA 70/5.9 71/8.7 73/9.0 110/6.0 65/4.2 67/6.5 68/9.7 110/6.0
Continuous
HLF AKR(mGy/min) 21.74 34.10 38.30 57.02 4.66 7.53 12.29 30.88
12pps kVp/mA 70/5.8 71/8.7 73/9.1 110/6.0 65/4.2 66/6.4 68/9.7 110/6.0
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AKR(mGy/min) 12.90 19.60 21.90 36.24 2.97 4.21 7.11 19.125

kVp/mA 70/5.8 71/8.6 73/9.1 110/6.0 66/4.4 67/6.8 69/9.5 110/6.0
8pps
AKR(mGy/min) 8.55 13.00 14.50 24.16 2.02 3.051 5.01 12.75
kVp/mA 70/5.8 71/8.7 73/9.1 110/6.0 66/4,5 67/6.9 69/9.5 110/6.0
4pps
AKR(mGy/min) 4.28 6.50 7.21 12.26 0.94 1.64 2.61 6.583
kVp/mA 70/5.8 71/8.7 73/9.1 110/22.7 66/4.6 68/7.0 69/9.5 110/22.7
2pps
AKR(mGy/min) 2.11 3.20 3.56 20.92 0.456 0.78 1.19 12.73
kVp/mA 70/5.8 71/8.7 73/9.1 110/22.7 65/4.2 68/7.2 70/9.5 110/22.7
1pps
AKR(mGy/min) 1.010 1.520 1.700 10.06 0.262 0.364 0.557 6.12
Field Size 9” 6” 4.5” 9” 6” 4.5”
kVp/mA 81/1.0 82/1.4 84/1.8 110/2.0 72/0.8 73/1.1 75/1.7 110/2.0
Continuous
AKR(mGy/min) 4.90 7.16 9.54 19.23 1.14 1.74 2.87 10.42
kVp/mA 82/1.0 82/1.4 85/1.8 110/2.0 73/0.8 74/1.2 76/1.7 110/2.0
12pps
AKR(mGy/min) 3.72 5.02 6.75 13.44 0.87 1.26 1.96 7.17
kVp/mA 82/1.0 82/1.4 85/1.8 110/2.0 73/0.8 74/1.2 76/1.7 110/2.0
8pps
AKR(mGy/min) 2.48 3.34 4.50 8.96 0.58 0.84 1.31 4.78
Low Dose
kVp/mA 82/1.0 82/1.4 85/1.8 110/2.0 73/0.8 74/1.2 76/1.7 110/2.0
4pps
AKR(mGy/min) 1.26 1.71 2.31 4.69 0.29 0.43 0.68 2.47
kVp/mA 82/1.0 82/1.4 85/1.8 110/2.0 73/0.8 74/1.2 76/1.7 110/2.0
2pps
AKR(mGy/min) 0.63 0.86 1.16 2.42 0.15 0.22 0.35 1.24
1pps kVp/mA 82/1.0 82/1.4 85/1.8 110/2.0 73/0.8 74/1.2 76/1.7 110/2.0
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AKR(mGy/min) 0.314 0.428 0.570 1.206 0.073 0.107 0.174 0.607

Field Size 9” 6” 4.5” 9” 6” 4.5”
kVp/mA 70/2.9 71/4.3 73/4.5 110/3.0 65/2.1 67/3.2 68/4.8 110/3.0
Continuous
AKR(mGy/min) 10.69 16.85 19.15 28.66 2.32 3.68 6.02 15.51
kVp/mA 70/2.9 71/4.3 73/4.5 110/3.0 65/2.1 66/3.2 68/4.8 110/3.0
12pps
AKR(mGy/min) 6.45 9.69 10.83 19.14 1.44 2.06 3.48 10.07
kVp/mA 70/2.9 71/4.3 73/4.5 110/3.0 66/2.2 67/3.4 69/4.7 110/3.0
8pps
HLF Low AKR(mGy/min) 4.28 6.43 7.17 12.76 1.01 1.49 2.45 6.71
Dose kVp/mA 70/2.9 71/4.3 73/4.5 110/3.0 66/2.2 67/3.4 69/4.7 110/3.0
4pps
AKR(mGy/min) 2.14 3.21 3.57 6.65 0.46 0.8 1.27 3.48
kVp/mA 70/2.9 71/4.3 73/4.5 110/3.0 66/2.3 68/3.5 69/4.7 110/3.0
2pps
AKR(mGy/min) 1.06 1.58 1.76 3.44 0.22 0.38 0.58 1.77
kVp/mA 70/2.9 71/4.3 73/4.5 110/3.0 65/2.1 68/3.6 70/4.7 110/3.0
1pps
AKR(mGy/min) 0.505 0.751 0.841 1.734 0.121 0.176 0.269 0.888
A-10
Field Size 9” 6” 4.5” 9” 6” 4.5”
Digital kVp/mA N/A N/A N/A 110/20 N/A N/A N/A 110/20
Continuous
Low Dose kVp/mA N/A N/A N/A 110/10 N/A N/A N/A 110/10
Digital Continuous
Field Size 9” 6” 4.5” 9” 6” 4.5”

kVp/mA 70/5.9 71/8.7 73/9.0 110/6.0 65/4.2 67/6.5 68/9.7 110/6.0
Continuous
AKR(mGy/min) 21.74 34.10 38.30 57.02 4.66 7.53 12.29 30.88
kVp/mA 70/5.8 71/8.7 73/9.1 110/6.0 65/4.2 66/6.4 68/9.7 110/6.0
Subtraction 12pps
AKR(mGy/min) 12.90 19.60 21.90 36.24 2.97 4.21 7.11 19.125
kVp/mA 70/5.8 71/8.6 73/9.1 110/6.0 66/4.4 67/6.8 69/9.5 110/6.0
8pps
AKR(mGy/min) 8.55 13.00 14.50 24.16 2.02 3.051 5.01 12.75
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Exposure Mode
During an exam, the configured active mode pair is displayed on the monitor and TechView tablet (control
panel)’s exposure mode status bar.
The left side of exposure mode status bar is triggered by the left pedal on the footswitch, or left black
button on hand switch. The right side of exposure mode status bar is triggered by the right pedal on
the footswitch, or the right yellow button on hand switch.
You can set imaging mode in HOME panel by mode setup screen or mode switch button on the footswitch.
There are three mode pairs to select, the selected mode pair will be displayed on the monitor and TechView
tablet (control panel)’s exposure mode status bar.
1. Fluoro /HLF
2. Fluoro /Subtract
3. Roadmap /Subtract
Imaging Mode List

The following list summarizes the modes available on the system. Additionally, it shows the X-ray
techniques available with each mode, the status bar and C-Arm TechView tablet (control panel) display for
each mode, and a brief list of examples for each mode. The examples are not exhaustive and other uses
may be as valid as the examples shown. The user must be aware of the techniques associated with the
various modes and monitor dose rates and doses for each patient.
⚫ Auto: X-ray techniques (kVp/mA) are adjusted automatically by system to optimize the image.
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⚫ Manual: X-ray techniques (kVp/mA) are adjusted manually by user to get the desired image.
The user can select Auto or Manual mode listed in the table below as she/he wants.
Mode X-ray Techniques Display Imaging Task

Normal Fluoro kVp:40 to 110
General fluoro imaging
Auto/ Manual mA: 0.1 to 4
High Level Fluoro kVp:40 to 110 High quality but high dose
Auto/ Manual mA: 0.2 to 12 rate imaging
Low Dose kVp:40 to 110 Continuous fluoro imaging

Auto/ Manual mA: 0.1 to 2 with a lower dose rate
Low Dose High Level kVp:40 to 110 High quality with a lower
Auto/ Manual mA: 0.1 to 6 + dose rate
Pulsed Normal Fluoro kVp:40 to 110 Reduce X-ray dose rate to

Auto/ Manual mA: 0.1 to 4 patient
kVp:40 to 110
Pulsed High Level
mA: 0.2 to 12 @ 4,8,12 pps High quality and low dose
Fluoro
mA: 0.2 to 25 @ 1,2 pps rate Imaging
Auto/ Manual
kVp:40 to 110
Pulsed Low Dose Reduce X-ray dose rate to
mA: 0.1 to 2 @1, 2, 4, 8,12 + patient
Auto/ Manual
pps
Pulsed Low Dose kVp:40 to 110

High Level High quality and low dose
mA: 0.1 to 12.5 @ 1,2 pps + + rate Imaging
Auto/ Manual mA: 0.1 ~ 6 @ 4, 8, 12 pps
kVp:40 to 110
Digital Spot mA: 0.2 to 20 @ 200V, 220V,

Short duration, high mA and
230V, 240V;
Auto high quality single imaging
mA 0.2 to 10 @ 100V, 110V,
120V.
kVp:40 to 110
Low Dose Digital mA 0.1 to 10 @ 200V, 220V, Short duration, high mA and
Spot 230V, 240V; + high quality single imaging
Auto with a lower dose rate
mA 0.1 to 5 @ 100V, 110V,
120V.
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TechView Tablet (Control Panel)

Mini ID Panel
Mini ID Panel’s activate button
Cine Save
Press this button to save last exposure as cine.
Pulse
In HOME panel, press this button to enable pulsed imaging, the default rate is “Continuous”, pulse rates are
1Pulse/s, 2Pulse/s, 4Pulse/s, 8Pulse/s, 12Pulse/s.
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Roadmap Mask
Press roadmap mask to setup the image in the control panel left part as roadmap mask, and the exposure
mode will be switched to Roadmap-2.
View Subtracted
Press View Subtracted to enable/disable the subtraction view. If the View Subtracted button is highlighted,
the cine run displays in subtracted form. To view the cine run in unsubtracted form, press View Subtracted
again, the button is no longer highlighted, and the cine run displays unsubtracted.
Peak Opacify
Press Peak Opacify to enable peak opacification. Use the Peak Opacify button during post-processing to
view a cine run with opacification.
The areas darkened by the contrast media remain dark in the playback of the run, providing maximum
vessel display.
Peak Opacify button is not used for Roadmap function, roadmap-1 is always with peak opacification.
Set Mask
Use the Set Mask button to set another mask for a post-processing subtraction on the left side of the
monitor. Set Mask is not used for Roadmap function.
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Mask Re-registration (Pixel Shift)

Use the mask re-registration buttons to align the mask image with the incoming images. Press Reset on
the screen to restore the mask to its original position.
Variable Landmarking
In some subtracted images, it may be necessary to see the position of vessels in relation to certain
background anatomies. Landmarking allows you to vary the percentage of background anatomy that
displays in a subtracted image. This function is available for subtraction and roadmap function.
Press the landmarking button or drag the progress bar slider to vary the percentage of background
anatomy.
Hold Reference Image

Use this button to switch the image displayed in the right monitor part between live image and reference
image set by user. It can be used in the subtraction or roadmap mode.
Vascular Imaging
Vascular imaging features include:
• Subtraction
• Roadmap
Subtraction
Real-time subtraction provides images that reflect the difference between current fluoroscopic images and
a mask image obtained at the start of the subtraction process. The result displays on the left side of the
monitor. The live, unsubtracted fluoro image displays on the right side of the monitor. By default, subtracted
images are acquired to the cine disk. Real-time subtraction is primarily used for contrast studies, such as
angiography.
Peak opacification can be applied during the cine review.
Use of pulsed fluoro modes for subtraction or roadmapping may result in poor image
CAUTION quality.
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If you are injecting contrast manually, begin injecting the contrast when the syringe icon
NOTE displays on the left side of the monitor.
Sequence of events during subtraction

The system software automatically performs several steps during real-time subtraction. To illustrate the
process, a time line diagram of a typical subtraction is shown below.
The sequence of events shown on the timeline includes:

1. The right X-ray switch is pressed to begin the exposure. The X-ray technique stabilizes.
2. The mask is acquired, and technique is locked.
NOTE Any movement results in a mask and incoming image mismatch.
3. The mask image has been acquired and the subtraction process begins.
The left side of the monitor displays a uniform gray result and the system begins subtracting images and
displaying them. As long as the subtraction continues, new images are subtracted from the mask obtained
at the beginning of the cine run. As images are acquired, a syringe icon displays indicating that the system
is ready for contrast to be injected.
4. Contrast is injected, and the subtracted images display on the left side of the monitor. Vessels are
highlighted with contrast.
5. The contrast concentration peaks.
6. Contrast concentration decreases to a minimum.
7. When the footswitch is released:
If Auto Playback is enabled, the subtraction cine run plays back automatically on the left side of the
monitor.
If Auto Playback is disabled, the last subtracted image displays on the left side of the monitor.
NOTE Early release of the X-ray switch terminates the subtraction process before it is complete.
Avoid tapping the footswitch in subtraction mode.
A-17
Subtraction procedure
1. Press the Exposure Mode Panel or Footswitch to activate subtraction mode, if necessary.
2. Verify that Subtract displays in the status bar. To change the cine frame rate, please use the Cine
screen.
3. Press and hold the right X-ray switch to begin the subtraction process and create a mask
automatically. Acquiring and creating the mask image can take at least 2 seconds, depending on the
mode used: at least 2 seconds for continuous mode.
4. After the mask is acquired, continue pressing the right X-ray switch to subtract subsequent images
from the mask. Subtraction begins when a subtracted image and the cine disk icon display on
the left side of the monitor.
5. A syringe icon displays on the left side of the monitor, signaling the operator to inject the contrast
medium. A signal will be sent to the injector connected to the system.
6. Subtracted images display on the left side of the monitor as the contrast concentration peaks and
decreases to a minimum. The unsubtracted view of the current live image displays on the right side of
the monitor as a reference.
7. Release the right X-ray switch to end the subtraction.
System provides mask registration function and landmarking function.

Roadmap
Roadmap mode provides a modified subtracted image on the left side of the monitor showing the
difference between the current fluoroscopic image and a roadmap mask image. Roadmapping is useful for
providing the anatomical location of pathology for proper placement of a catheter, balloon, or stent.
During the first phase of roadmapping, a mask image is created using contrast media.
During the second phase of roadmapping, new incoming images are subtracted from the mask image. The
result displays on the left side of the monitor, and the right side of the monitor displays the live,
unsubtracted image.
Peak opacification is enabled automatically during the first phase of roadmapping (mask acquisition). When
peak opacification is applied, each pixel is compared, as it is acquired, to its counterpart in the previous
image. If the new pixel is darker than in the previous image, the old pixel is replaced. When this process is
complete, the resulting image contains the darkest pixels acquired for each point. Opacification is turned
off during the second phase of roadmapping.
Continuous X-ray mode should be used for roadmapping.
If you are using a mechanical contrast injector, but no signal from the system is sent
when the syringe icon displays on the left side of the monitor, the injection of contrast
NOTE
should be manually initiated. If the problem continues when restart the system, please
contact with GE Healthcare authorized service engineer.
A-18
Sequence of events during Roadmap imaging

The software automatically performs several steps during road mapping. The following illustrates
and describe the process:
1st phase:
1. X-ray switch is pressed. X-ray technique adjusts and stabilizes. Roadmap- 1 displays in status bar.
2. Syringe icon displays. Contrast injection begins, and contrast concentration in image increases.
3. Vessels and contrast displays, at or near peak concentration.
4. Footswitch released. Peak opacification is automatically applied.
5. Last image saves automatically as mask. X-ray technique is frozen.
6. Peak opacification causes areas darkened by contrast to retain their darkest values in mask image.
2nd phase:
7. X-ray switch is pressed again. Roadmap subtraction begins. Roadmap–2 displays in the status bar.
8. X-ray technique is the same as during mask acquisition. Press X-ray switch to continue roadmapping.
New incoming images are subtracted from mask image. Result displays on the left side of the monitor.
Roadmap procedure
1. If need, select the fluoro mode from the mode status bar or press mode switch button on the
footswitch, press the left X-ray switch to create a fluoro image to confirm position.
2. Switch to roadmap mode using the mode status bar or pressing mode switch button on the footswitch,
make sure Roadmap-1 is displayed on the mode status bar.
3. Press the left X-ray switch to initiate the first phase of roadmapping. Roadmap–1 displays in the left
side of the status bar. While the left X-ray switch is being pressed, the syringe icon displays on the left
side of the monitor. Inject contrast media.
4. Release the left X-ray switch when a satisfactory image displays on the left side of the monitor and the
contrast is at, or near, peak concentration in the area of interest. The system enters phase 2
automatically when the X-ray switch is released.
5. The roadmap mask is created automatically and displays on the left side of the monitor. This mask is
saved, and the thumbnail on the Images screen displays a mask icon.
6. Press the left X-ray switch again to begin roadmapping. Roadmap–2 displays on the left side of the
status bar. The saved mask is subtracted from the new fluoro image. The resulting roadmap displays
on the left side of the monitor, while the right side of the monitor displays the current live fluoro image.
The X-ray technique is locked.
A-19
7. As long as Roadmap-2 displays in the status bar, continue roadmapping as many times as necessary
by pressing the left X-ray switch. The original contrast image is used as the roadmap mask.
8. To exit Roadmap mode, select from the mode status bar or press the mode switch button on the
footswitch.
Clear the current mask

To begin a new roadmap procedure:
1. Select Fluoro Mode on the mode status bar or press mode switch button on the footswitch.
2. Optional: Press the left X-ray switch to create a fluoro image to confirm position.
3. Select Roadmap-1 mode on the mode status bar or press mode switch button on the footswitch again.
Select a Roadmap mask

Any previous image or mask created using contrast media can be used as a roadmap mask. This
eliminates the need for additional contrast media. Use any of the following as a mask:
• A recalled mask from the current procedure

• A frame from a cine run from the current procedure
• A Last Image Hold from the current procedure
• A recalled image from the current procedure
Images should be from the current procedure because patient positioning must be the same as it was
when the recalled mask was created. Use the Mask Registration screen to compensate for slight movement.
(Please refer to Dynamic Recording (Cine) chapter for information about mask registration.)
The selected roadmap mask would be saved with the thumbnails include a mask icon on the Images
directory screen.
A frame from a roadmap cine, roadmap-2 last image hold and a recalled subtracted
NOTE
image cannot be set as roadmap mask.
Use a recalled mask
A roadmap mask can be created from a saved mask from the current exam.
To perform a roadmap procedure using a saved mask:
1. Recall a mask. The thumbnail will be identified with a mask icon. Press Roadmap Mask on the Cine
screen.
2. When Roadmap-2 displays in the status bar, indicating that the second phase of roadmapping is in
process, the current mask image displays on the left side of the monitor.
3. Press the left X-ray switch. The technique will stabilize and roadmapping will begin using the image
A-20
from step 1, above, as the mask.
4. If necessary, Press Mask Registration screen to adjust registration.
Produce a Roadmap mask from a cine run

A roadmap mask can be created from a cine run except roadmap cine, from the current exam. This method
avoids additional contrast injection and reduces patient exposure.
To perform a roadmap procedure using a frame from a cine run as the mask:
1. Select the cine run from the Images screen. The cine run begins playback on the left side of the
monitor. The Cine screen displays on the right side of the monitor.
2. Optional: Press Peak Opacify to enable peak opacification.
3. Use the cine playback buttons to navigate to and select the frame you want to use as the mask on the
left side of the monitor.
4. Press Roadmap Mask on the Cine screen.
5. The image on the left side of the monitor becomes the roadmap mask, and the system enters the
Roadmap-2.
6. Press the left X-ray switch. The technique stabilizes and roadmapping begins.
Use a Last Image Hold as a mask

A roadmap mask can be created from a Last Image Hold from the current exam.
To perform a roadmap procedure using a Last Image Hold as the mask:
2. The image on the left side of the monitor becomes the roadmap mask and the system enters
Roadmap-2 phase.
3. Press the left X-ray switch. The technique will stabilize and roadmapping will begin.
4. If necessary, Press Mask Registration to adjust registration.
Use a recalled image as a mask

A roadmap mask can be created from a recalled image from the current exam.
To perform a roadmap procedure using a recalled image as the mask:
1. Select the image from the images directory screen. The image displays on the left side of the monitor.
3. The image on the left side of the monitor becomes the roadmap mask and the system enters
Roadmap-2 phase.
4. Press the left X-ray switch. The technique will stabilize and roadmapping will begin.
5. If necessary, Press Mask Registration on the Cine screen to adjust registration.
A-21
Dynamic Recording (Cine)

System provides hard disk to save dynamic recording (cine). Use Cine screen to setup the record mode and
rate, cine viewing options and cine playback. Click Minimize to display mini cine playback screen.
A-22
The system and cine disk are always running. Any sudden, intense impact can damage the
system or cine disk and could result in loss of previously recorded cine runs and prevent
further imaging.
Topics in this chapter include:
• Cine setup
• Cine review
During cine acquisition, images are recorded to the cine disk until the acquisition is complete.
Cine runs can be saved to a USB device or DICOM server for further review after the exam
NOTE completes.
When acquiring a cine run, the system will save the run after the video has stabilized and 2 frames have
been captured.
When recoding begins, the cine disk icon displays on the left corner of the screen.
The screen displays the cine storage time remaining in number of seconds. This number displays on the
right side of the monitor.
During acquisition, when storage space is not enough (available storage cine time is 0), there is extra
storage space left to continue to acquire. But when the extra storage space is full, system cannot continue
to acquire cine.
Before starting acquisition, when storage space is not enough (available storage cine time is 0), system will
be unable to initiate cine acquisition. System will display the information that there is no more space until it
is free when pressing X-ray switch.
While using the system, please save or delete unused cine on time to ensure enough cine storage.
A-23
Cine setup
Press the Cine button to display the cine setting and playback functions.
Use the Cine screen to enable cine acquisition and change the recording rate (frame rate).
Cine storage time
Displays the remaining time for cine.
When the cine storage time is used up (cine disk is fully occupied), fluoroscopy without cine record set can
operate normally, but the cine save is limited. Check up the remaining cine time for the system regularly to
make sure there is enough storage time. The system provides at least 90 minutes cine storage time.
A-24
Select image modes for cine recording
Select the check box next to the corresponding imaging mode to enable or disable cine recording. The
available image modes include: Fluoro, HLF and Roadmap. Cine recording is enabled if the box is selected.
This feature is always enabled for Subtract.
A-25
Select a continuous acquisition rate
The default recording rate for continuous mode is 8 fps. Recording rate is enabled for selected image
modes, displays on the upper left of the monitor UI and on the mode status bar of the control panel.
Mode status bar displays the recording rate as the following picture shows when cine acquisition is enabled
for that mode and the mode is selected. For example, the recording rate for subtract is 25 fps.
The available acquisition time, listed as seconds remaining, varies according to the record rate. A higher
rate reduces the amount of acquisition time and a lower rate saves the amount of acquisition time.
Remaining cine recording seconds displays on the upper right of the interface.
Pulsed mode acquisition rate

In pulsed modes, if the record rate check box is selected, acquisition is performed at the pulsed rate, and
the selected record rate is ignored.
Cine Save
System provides cine save function, the cine save button is on the left corner of monitor and the right
corner of control panel.
Using cine save function, system can save at least 240 frames cines (only save the last 240 frames images)
after exposure.
Continues exposure saving rate is consistent with the cine record rate. Pulse exposure saving rate is pulse
rate.
Cine Save function doesn’t work when the cine record has been saved by default, system beeps when
touching the button.
A-26
Cine Review
Use the Cine screen to review a cine run, adjust landmark and registration, define a roadmap mask, or
select a mask at any point in the run to reprocess a subtraction.
A-27
Review a cine run
Use Image Directory to display all images and cine runs.
To review a cine run:
1. Press the Images Directory button to display the Images Directory screen, all images and cine
runs for the current patient.
Cine run thumbnails include a letter C next to the image number on the Images directory
screen.
A-28
Cine runs display the same exam information as static images. The post-processing functions apply to
a single frame of a cine run.
2. Select the thumbnail of the cine run in the Images Directory screen. Cine playback occurs on the left
side of the monitor and the Cine screen displays on the right side of the monitor.
3. As playback progresses through the acquired images, the frame number changes to indicate the
position of the frame within the run.
1 5 2 3 4
1.Progress bar
2.Cine play position slider
3. Current Frame number
4. Current cine play time (in seconds)
5. Mask frame
4. Replay continues to loop until you Press the Play / Pause button to pause the run to view a single
frame or exit.
1 3 5 4 2 6
1. Press to review the previous cine run for the current patient.
2. Press to review the next cine run for the current patient.
3. Press to move back by a single frame.
4. Press to move forward by a single frame.
5. Press or to pause, begin, or resume cine playback.
6. The total number of runs is noted as X (cine run currently being reviewed) / X (the number
of runs available for review).
5. TechView Tablet (control panel) provides the same functions as defined above.
A-29
Viewing Options
Cine screen provides viewing options, each button operation instructions is as below.
Roadmap Mask
Use this button to select an image or cine frame as a roadmap mask.
Select from a Last Image Hold, a recalled image, or a frame from a subtracted or unsubtracted cine run to
produce a roadmap mask.
A-30
View Subtracted
Press View Subtracted on the Cine screen to enable subtracted view.
To view the run in unsubtracted form, Press View Subtracted again. The button is no longer highlighted and
the cine run displays unsubtracted.
Peak Opacify
Peak opacification is an image processing. Each pixel of a new frame is continuously compared with its
counterpart in the previous frame. If the new pixel is darker than in the previous image, the old pixel is
replaced. The processed image contains the darkest pixels acquired for each point.
Set Mask
Use the playback buttons to display a selected frame as the mask on the left side of the monitor. Press Set
Mask, the selected mask frame is indicated on the progress bar. Use the playback buttons to review the
cine runs. “Set Mask” could not be used in roadmap cine run.
Mask Registration
If the patient moves during a subtraction or roadmap, misalignment of the mask and images that need to
be subtracted could cause a poor image. Registration allows you to move the mask image to produce an
accurate registration by realigning the mask and the images that need to be subtracted. You can realign
the mask during the procedure, or during playback if the images are saved.
To adjust the mask:

1. Use the mask registration button to align the mask image with images that need to be subtracted.
2. Press on the screen to reset the mask to its original position.
Landmarking
A-31
In some subtracted images, it is necessary to see the position of vessels in relation to certain background
anatomies. Landmarking allows you to vary the percentage of background anatomy that displays in a
subtracted image. This function is available for subtraction and roadmap imaging.
The mask is adjusted incrementally with pressing of the landmarking button. The percentage of
background anatomy can be quickly varied by dragging the slider on the progress bar.
The Cine screen provides the following review options:
• Review a cine run in subtracted or unsubtracted form.
• Perform a post-processing subtraction from a fluoro or HLF run.
• Apply peak opacification to a subtracted or unsubtracted run.
Review options can also be operated on the techview tablet (control panel).
Review a cine run in subtracted or unsubtracted form

Enable and disable subtracted view by pressing View Subtracted on the Cine screen.
If the View Subtracted button is highlighted, the cine run displays in subtracted form.
To view the run in unsubtracted form, Press View Subtracted again. The button is no longer highlighted and
the cine run displays unsubtracted.
Perform a post-processing substraction

If contrast has been injected during acquisition of fluoro or HLF cines, the run can be played back or used
for a mask. Use the Set Mask and View Subtracted buttons to display a post-processing subtraction on the
left side of the monitor.
The displayed image should not have any contrast material in it prior to selecting Set Mask
NOTE
or vessel visualization will be lost.
To perform a post-processing Subtraction using a fluoro or HLF image:
1. Display the run to use as the mask on the left side of the monitor.
2. Press Set Mask.
3. Press View Subtracted.
The fluoro or HLF cine run displays as a subtraction on the left side of the monitor. Use the cine playback
buttons to review the run.
A-32
Apply peak opacification to a subtracted or unsubtracted run

Use the Peak Opacify button during post-processing to view a subtracted or unsubtracted run with
opacification. The areas darkened by the contrast media remain dark in the playback of the run, providing
maximum vessel display.
NOTE Peak Opacify button is not used for Roadmap function, roadmap-1 is always with peak
opacification.
Mini cine playback
Mini cine playback allows you to review cine runs using playback controls displayed on the same screen
with the cine run. To activate mini cine, Press Minimize on the Cine Playback screen. A screen similar to the
following displays.
1 2
6
5
1. Roadmap Mask– used to select a roadmap mask from previously saved masks or create a mask from
a subtraction cine run.
2. Peak Opacify– applies peak opacification to the current cine run.
3. Cine playback and Mask indicator bar – shows progress of playback and the mask frame, the current
frame and play time.
4. Maximize–returns to Cine screen.
A-33
5. Cine playback controls – Play/Pause, Forward/Back one frame, Forward/Back cine run for selected
patients, Current/total cine runs for selected patient.
6. Exit–exits cine playback.
Export, Import and Retrieve

The system will support cine export, import and retrieve.
Cine export supports MP4 and RAW format. Cine import supports RAW format.
Cine System Setup
Select Cine to enter cine system setup screen.

Use “Cine” setup screen to:
• Enable/disable “Auto Playback When Cine Acquired”
• Enable/disable “Use Mini Player When Playback”
A-34
Dose Reproducibility and mA Linearity Check

1. Put dose meter sensor on the I.I. surface center. Place aluminum pieces on the tube cover, the
thickness is indicated in Filtration Aluminum Thickness (mm) row.
2. Set the imaging mode as digital spot mode.
3. Make 10 measurements of dose (AIR KERMA) in one hour under the test conditions, at each of the test
settings A, B, C, D, E and F according to the table below.
Air Kerma: 10 measurements in 1 hour at each setting

Test settings for: A B C D E F
X-ray tube voltage (kV): 40 110 55 88 55 88
X-ray tube current (mA): 8 0.5 Q1(a)=4 Q1(b)=1.9 Q2(a)=4.2 Q2(b)=2.3
Filtration aluminum thickness 4 40 16 30 16 30
(mm)
Test No. Measured AIR KERMA (mGy)
1
2
3
4
5
6
7
8
9
10
Average value of dose (AIR K1(a)= K1(b) = K2(a) = K2(b) =
KERMA):
Measured coefficient of
variation:
4. Calculate the dose reproducibility by coefficient of variation(COV) for each of the measurement series
and the average dose according to the definition below. Dose reproducibility is concluded with
maximum value calculated.
A-35
COV definition:
x means measured value of dose and n is 10.

5. Calculate mA linearity by these average dose and mAs at these test settings C, D, E and F according to
the definition below.
Linearity definition:
K means value of dose of each setting, Q means mAs value of each setting.
A-36
X-ray Generator
• Nominal electric power:
2.0kW (100kV, 20mA, 0.1s)
• Maximum electric power:
Normal Fluoro 440W (110kV, 4mA)
High Level Fluoro 660W (110kV, 6mA; 55kV, 12mA)
Low Dose 220W (110kV, 2mA)
Digital Spot 2.2 kW (110kV, 20mA) @ 200V, 220V, 230V, 240V;
1.1 kW (110kV, 10mA) @ 100V, 110V, 120V
High Level Pulse 2.5kW (100kV，25mA，1/2PPS)
• High frequency generator: 40kHz
• Voltage: 40kV~110kV
Normal Fluoro When the X-ray tube current reaches its highest value of 4mA, the
High Level Fluoro When the X-ray tube current reaches its highest value of 6mA, the
Low Dose When the X-ray tube current reaches its highest value of 2mA, the
Pulse Normal Fluoro When the X-ray tube current reaches its highest value of 4mA, the
Low Dose Pulse Fluoro When the X-ray tube current reaches its highest value of 2mA, the
High Level Pulse Fluoro When the X-ray tube current reaches its highest value of 22.7mA, the
obtainable highest X-ray tube voltage is 110kV at 1/2 pps;
obtainable highest X-ray tube voltage is 110kV at 4/8/12 pps;
Digital Spot When the X-ray tube current reaches its highest value of 20mA, the
obtainable highest X-ray tube voltage is 110kV @ 200V, 220V, 230V, 240V.
obtainable highest X-ray tube voltage is 110kV @ 100V, 110V, 120V.
• Current:
Normal Fluoro 0.1 mA~4 mA; when the X-ray tube voltage reaches its highest value of
High Level Fluoro 0.2 mA~12 mA; when the X-ray tube voltage reaches its highest value of
Low Dose 0.1 mA~2 mA; when the X-ray tube voltage reaches its highest value of
Pulse Normal Fluoro 0.1 mA~4 mA; when the X-ray tube voltage reaches its highest value of
Low Dose Pulse Fluoro 0.1 mA~2 mA; when the X-ray tube voltage reaches its highest value of
A-37
High Level Pulse Fluoro 0.2 mA~12 mA; when the X-ray tube voltage reaches its highest value of
55kV, the obtainable highest X-ray tube current is 12mA at 4/8/12pps.
100kV, the obtainable highest X-ray tube current is 25mA at 1/2pps.
Digital Spot 0.2 mA~20 mA; when the X-ray tube voltage reaches its highest value of
230V, 240V.
120V.
• Pulse Fluoro: 1/2/4/8/12pps
• kVp Accuracy: 7%
• mA Accuracy: 10%
• Linearity: < 0.18
• Reproducibility Coefficient of Variation (COV): < 0.045
• Measurement Basis for Technique Factors:
kVp – The peak value of high voltage generator output in the interval after a 20 ms delay period to the
end of the exposure.
mA – The time average of the current flow into the high voltage cable/X-ray tube assembly, at
beginning the point where kVp crosses the 35 kVp level.
Time – Measurement of exposure time begins when the kVp crosses the 35 kVp level (80% of kVp selected).
A-38
Wireless Regulatory Information for EU

Wireless Parts Included
The following wireless parts are included in this product:
Item Name Function GE P/N Frequency Transmit Standard/ Wireless

Band Power (EU) Security:
OPEN
1 Wireless Wireless network 6888961 2.4GHz, 5GHz <20 dBm
WEP (64/128)
Module connection for (2.4GHz)
WPA-PSK (AES)
DICOM
<23 dBm WPA2-PSK (AES)
(5GHz) IEEE 802.1X (EAP-PEAP,
EAP-TLS, EAP-TTLS)
2 Wireless Wireless control 9888222 2.4GHz <7 dBm Bluetooth LE
Footswitch for exposure
3 Wireless Wireless 7888168 7392 MHz to <0 dBm AES128

Print System connection for 8448 MHz
printers
The wireless module parts come with the following system software versions:
Item Name System software release version

1 Wireless Module 2
2 Wireless Footswitch 2
3 Wireless Print System 2
Technical specifications of wireless DICOM module:

About the technical specifications and encryption mechanism, please refer to Operator Manual and
Supplement.
5150-5350MHz frequency range is restricted to indoor use only, Outdoor operation in this range is
prohibited.
Declaration of Conformity (for RED)
The wireless module listed above is CE marked according to the provisions of the RED Directive
(2014/53/EU) when the system and wireless module attached the CE mark.
The following information is applicable when the system and wireless module attached the CE mark:
GE HUALUN Medical Systems Co. Ltd, here by declares that the system is in compliance with the essential
requirements and other relevant provisions of Directive 2014/53/EU.
The Declarations of Conformity made under Directive 2014/53/EU are available on the website:
http://www3.gehealthcare.com/en/Global_Gateway
A file compression/archival (zip/unzip) utility must be installed on the user’s computer.
A-39
Options and Accessories
Wireless Print System

Printer configuration depends on user’s system configuration and compliance with applicable regulations
and standards:
Type UP-X898MD UP-971AD UP-991AD
Power 100 to 240V AC, 50/60Hz 100 to 240V AC, 50/60Hz 100 to 240V AC, 50/60Hz
Requirements
Dimensions 154 X 88 X 240 mm 316 X 132.5 X 265 mm 316 X 132.5 X 265 mm
(W X H X D)
Weight Approx. 2.5 kg Approx. 7 kg Approx. 7 kg
Resolution 325 dpi 325 dpi 325 dpi
Grayscale 256 levels processing 256 levels processing 256 levels processing
Pixel Digital: 4096 X 1280 dots Digital: 7680 X 2560 dots Digital: 7680 X 2560 dots
Video NTSC: 720 X 504 dots Video NTSC: 720 X 504 dots Video NTSC: 720 X 504 dots
Video PAL: 720 X 604 dots Video PAL: 720 X 604 dots Video PAL: 720 X 604 dots
Interface Hi-Speed USB (USB2.0) (X1) Hi-speed USB (USB2.0) (X1) Hi-speed USB (USB2.0) (X1)
VIDEO INPUT: BNC type (X1) VIDEO INPUT: BNC type (X1) VIDEO INPUT: BNC type (X1)
NTSC or PAL composite video NTSC or PAL composite video NTSC or PAL composite video
signals 1.0 Vp-p, 75 ohms signals 1.0 Vp-p, 75 ohms signals 1.0 Vp-p, 75 ohms
(NTSC/PAL automatically (NTSC/PAL automatically (NTSC/PAL automatically
discriminated) discriminated) discriminated)
VIDEO OUTPUT: BNC type (X1) VIDEO OUTPUT: BNC type (X1) VIDEO OUTPUT: BNC type (X1)
Loop-through Loop-through Loop-through
REMOTE: Stereo mini jack (X1) REMOTE: Stereo mini jack (X1) REMOTE: Stereo mini jack (X1)
USB terminal (type A) for USB USB terminal (type A) for USB
flash drive (X1) flash drive (X1)
For more information, refer to the printer user manual.
The system provides an optional wireless print system UPA-WU10, which supports wireless printing of the
printer UP-971AD and UP-X898MD.
Wireless print system depends on the local configuration.
A-40
The wireless print system specifications are as below:

Feature Description
Communication System UWB (Ultra Wide Band)
Transmit/ Receive Frequency Range 7392MHz to 8448MHz
Band Band Group #6 (Band #9, #10)
Center Frequency 7656MHz and 8184MHz
Band Width 528 MHz
Maximum Peak Power 0 dBm
Maximum Range Approx. 10m line-of-sight
Maximum Devices in Use Simultaneously 3
Operating Temperature 5°C to 40°C
User shall operate in the following sequence for wireless printing:
1. Turn on the OEC One system.

2. Insert the transmitter to USB port on the system and the receiver to the printer.
Then turn on the printer.
3. The printing can be performed after the connection of the transmitter and the receiver is
established.
In the event of a connection interruption during printing, please repeat step 2 if necessary.
For more information, refer to the wireless print system user manual.
The image from the printer should not be used for diagnostic purposes.
A-41
www.gehealthcare.com
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OEC OneTM

Mobile C-Arm X-Ray Product

GE HUALUN Medical Systems Co. Ltd.

1.13. External Devices ............................................................................................................................................................. 1-30

5.3. Resume Performed Exams ............................................................................................................................................. 5-5

9.4. DICOM Print .......................................................................................................................................................................... 9-12

13.2. Error Recovery Steps ..................................................................................................................................................... 13-2

Chapter 16. Privacy and Security .......................................................................... 16-1

Appendix：Operator Manual Supplement............................................................ A-1

1.2. Owner Responsibilities

1.2.1. System Compatibility

1.2.2. Operator Qualifications

1.2.3. Continued Compliance

Wireless Regulatory Information for EU

The following wireless parts are included in this product:

Item Name Function GE P/N Frequency Band Transmit Power

1 Wireless Wireless network 6888961 2.4GHz, 5GHz <20 dBm (2.4GHz)

Item Name System software release version

Technical specifications of wireless DICOM module:

1.2.4. Unauthorized Modifications

1.3. Manufacturer's Responsibilities

1.3.1. X-ray Equipment Certification

1.3.2. After-sale Operating and Safety Practices

1.3.3. Essential Performance

1.4. Communication Center Telephone

1.5. Safety Hazards

1.5.1. Safety Hazard Alerts

NOTE NOTE is given in situation requiring special attention.

1.5.3. Equipment Stability and Positioning

Never attempt to move the system up or down steps.

1.5.4. Mechanical Movement

1.5.5. Improperly Attached Equipment

Attach the equipment or accessories properly. Incorrectly attached equipment or

1.5.6. Electrical Shock

1.5.7. Electrical Fire

1.5.8. Ground Fault

Do not operate the system.

1.5.9. Improper Access

1.6. Radiation Exposure

1.6.2. Source-Skin Distance

1.6.3. Dose to Patient

Biological Deterministic Effects of Radiation

Patient Entrance Reference Point

Without Filter, With Grid With Filter, Without Grid

AKR(mGy/min) 0.314 0.428 0.57 1.206 0.073 0.107 0.174 0.607

Field Size 9" 6" 4.5" 9" 6" 4.5"

1.6.4 Scattered Radiation

Stray Radiation in Significant Zones of Occupancy

Horizontal & Vertical Plane Test

Measurement Dose Rate (mGy/h)

Measurement Dose Rate (mGy/h)

ISO Kerma Map Test

Vertical configuration Horizontal configuration

Lateral configuration, 1.5m: Lateral configuration, 1m:

Vertical configuration, 1.5m: Vertical configuration, 1m:

1.7. Ingress of Fluids

1.7.2. Communication center contact information

1.8. Cooling Efficiency

1.10. Electromagnetic Compatibility Statement

To comply with the regulations applicable to an electromagnetic interface for a Group 1,

Guidance and manufacturer’s declaration – Electromagnetic Emissions

Guidance and manufacturer’s declaration - Electromagnetic Immunity

Guidance and manufacturer’s declaration - Electromagnetic Immunity