GE Proteus XR-a User Manual

GE Medical Systems

Technical Publications

Direction 2259724-100

Revision 22

Proteus XR/a Operator Manual

0459

PROTEUS XR/a

GE MEDICAL SYSTEMS Operator Manual REV 22 DIRECTION 2259724-100

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PROTEUS XR/a

CAUTION

GE MEDICAL SYSTEMS Operator Manual REV 22 DIRECTION 2259724-100

IMPORTANT!...X-RAY PROTECTION

X-ray equipment if not properly used may cause injury. Accordingly, the instructions herein contained should be thoroughly read and understood by everyone who will use the equipment before you attempt to place this equipment in operation. The General Electric Company, Medical Systems Group, will be glad to assist and cooperate in placing this equipment in use.

Although this apparatus incorporates a high degree of protection against x-radiation other than the useful beam, no practical design of equipment can provide complete protection. Nor can any practical design compel the operator to take adequate precautions to prevent the possibility of any persons carelessly exposing themselves or others to radiation.

It is important that everyone having anything to do with x-radiation be properly trained and fully acquainted with the recommendations of the National Council on Radiation Protection and Measurements as published in NCRP Reports available from NCRP Publications, 7910 Woodmont Avenue, Room 1016, Bethesda, Maryland 20814, and of the International Commission on Radiation Protection, and take adequate steps to protect against injury.

The equipment is sold with the understanding that the General Electric Medical Systems, its agents, and representatives have no responsibility for injury or damage which may result from improper use of the equipment. Various protective material and devices are available. It is urged that such materials or devices be used.

Federal law restricts this device to sale by or on the order of a physician.

PROTEUS XR/a

CERTIFIED ELECTRICAL CONTRACTOR STATEMENT

If you have any comments, suggestions or corrections to the information in this document, please write them down, include the document title and document number, and send them to: GENERAL ELECTRIC MEDICAL SYSTEMS MANAGER - INFORMATION INTEGRATION AMERICAS, X-RAY W-622 P.O. BOX 414 MILWAUKEE, WI 53201-0414

GE MEDICAL SYSTEMS Operator Manual REV 22 DIRECTION 2259724-100

All electrical installations that are preliminary to positioning of the equipment at the site prepared for the equipment shall be performed by licensed electrical contractors. In addition, electrical feeds into the Power Distribution Unit shall be performed by licensed electrical contractors. Other connections between pieces of electrical equipment, calibrations, and testing shall be performed by qualified GE Medical personnel. The products involved (and the accompanying electrical installations) are highly sophisticated, and special engineering competence is required. In performing all electrical work on these products, GE will use its own specially trained field engineers. All of GE’s electrical work on these products will comply with the requirements of the applicable electrical codes.

The purchaser of GE equipment shall only utilize qualified personnel (i.e., GE’s field engineers, personnel of

third-party service companies with equivalent training, or licensed electricians) to perform electrical servicing on the equipment.

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GE MEDICAL SYSTEMS Operator Manual REV 22 DIRECTION 2259724-100

REGULATORY REQUIREMENTS

This product complies with the regulatory requirements of the following:

 Council Directive 93/42/EEC concerning medical devices: the CE label affixed to the

product testifies compliance to the Directive.

The location of the CE label on the product is described page 2-4.

 EU Authorized Representative:

GE Medical Systems SCS 283 rue de la Minière 78530 BUC, FRANCE

 Green QSD 1990 Standard issued by MDD (Medical Devices Directorate, Department

of Health, UK).

 Quality System Regulation issued by the FDA (Food and Drug Administration,

Department of Health, USA).

 Underwriter’s Laboratories, Inc. (UL), an independent testing laboratory.  Canadian Standards Association (CSA).  International Electrotechnical Commission (IEC).

The following equipment classifications are applicable to the product:

 Equipment classification with respect to protection from electric shock: Class 1  Degree of protection from electric shock: Type B  Degree of protection against ingress of liquids: not classified  Equipment not suitable for use in the presence of a flammable anaesthetic mixture with

air or with nitrous oxide; mode of operation: continuous

 Mode of operation: continuous with intermittent loading  The Proteus XRa has only level 1 EMC susceptibility immunity responses.

UDI Label

Every Proteus XR/a system has an unique marking for identification. The Unique Device Identification (UDI) marking appears on the product label which is located on system cabinet.

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WARNING

GE MEDICAL SYSTEMS Operator Manual REV 22 DIRECTION 2259724-100

ELECTROMAGNETIC COMPATIBILITY (EMC)

This product conforms with IEC 60601-1-2:2001+A1:2004 EMC standard for medical devices.

Note: This equipment generates, uses, and can radiate radio frequency energy. The

equipment may cause or subject to radio frequency interference with other medical and non–medical devices and radio communications. To provide reasonable protection against such interference, the Proteus XR/a System (32, 50, 65, 80kW) complies with emissions limits for a Group 1, Class A Medical Devices and has applicable immunity level as stated in EN IEC 60601-12:2001+A1:2004.

However, there is no guarantee that interference will not occur in a particular

installation. Special precautions and other information regarding EMC provided in the accompanying documents of this equipment shall be observed during installation and operation of this equipment.

Note: If this equipment is found to cause interference (which may be determined by

switching the equipment on and off), the user (or qualified service personnel) should attempt to correct the problem by one or more of the following measure(s):

 Reorient or relocate the affected device(s).  Increase the separating space between the equipment and the affected

device.

 Power the equipment from a source different from that of the affected

device.

 Consult the point of purchase or service representative for further

suggestions.

Use of accessories, transducers, cables and other parts other than those

specified by the manufacturer of this equipment may result in increased emissions or decreased immunity of the equipment. The manufacturer is not responsible for any interference caused either by the use of interconnect cables other than those recommended, or by unauthorized changes or modifications to this equipment. Unauthorized changes or modifications could void the user’s authority to operate the equipment.

PROTEUS XR/a

The Proteus XR/a system is suitable for use in the specified electromagnetic environment. The purchaser or user of the Proteus XR/a system should assure that it is used in an electromagnetic environment as described below:

Emissions Test

Compliance

Electromagnetic Environment

RF Emissions

CISPR11

Group1

The Proteus XR/a system uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF Emissions

CISPR11

Class A

The Proteus XR/a system is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Harmonic emissions

IEC 61000-3-2

Not applicable

Voltage fluctuations/

flicker emissions

IEC 61000-3-3

Not applicable

GE MEDICAL SYSTEMS Operator Manual REV 22 DIRECTION 2259724-100

ELECTROMAGNETIC COMPATIBILITY (EMC) (CONT.)

Note: To comply with the regulations applicable to an electromagnetic interface for a

Group 1, Class A Medical Device, and to minimize interference risks, the following requirements shall apply:

 All interconnect cables to peripheral devices must be shielded and

properly grounded. Use of cables 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.

 All of those recommended guidance regarding electromagnetic

environment should be followed.

Note: Do not use devices that intentionally transmit RF signals (Cellular Phones,

Transceivers, or Radio Controlled Products) in the vicinity of this equipment as it may cause performance outside the published specifications. Keep the power to these type devices turned off when near the equipment. The medical staff in charge of this equipment is required to instruct technicians, patients, and others.

Guidance and manufacturer’s declaration – Electromagnetic Emissions

ELECTROMAGNETIC COMPATIBILITY (EMC) (CONT.)

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Immunity Test

IEC 60601-1-2

Test Level

Compliance

Level

Electromagnetic Environment

Electrostatic discharge (ESD) IEC 61000-4-2

6 kV contact 8 kV air

Floors are wood, concrete, or ceramic tile, or floors are covered with synthetic material and the relative humidity is at least 30 %.

Electrical fast transient/burst IEC 61000-4-4

2 kV for power supply lines

1 kV for input/output lines

2 kV for power supply lines

1 kV for input/output lines

Mains power quality is that of a typical commercial and/or hospital environment

Surge IEC 61000-4-5

1 kV differential mode 2 kV common mode

Mains power quality is that of a typical commercial and/or hospital environment.

Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

< 5 % UT (> 95 % dip in UT) for 0.5 cycle

40 % UT (60 % dip in UT) for 5 cycles

70 % UT (30 % dip in UT)

< 5 % UT (> 95 % dip in UT) for 5 s

0 % UT for 5 sec

Mains power quality is that of a typical commercial and/or hospital environment. If the user of the Proteus XR/a system requires continued operation during power mains interruptions, it is recommended that the Proteus XR/a system be powered from an uninterruptible power supply or a battery.

Power frequency (50/60 Hz) magnetic field IEC 61000-4-8

3 A/m

Power frequency magnetic fields are at levels characteristic of a typical location in a typical commercial and/or hospital environment.

Note: These are guidelines. Actual conditions may vary.

GE MEDICAL SYSTEMS Operator Manual REV 22 DIRECTION 2259724-100

Guidance and manufacturer’s declaration - Electromagnetic Immunity (1)

ELECTROMAGNETIC COMPATIBILITY (EMC) (CONT.)

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viii

Immunity

Test

IEC 60601-1-2

Test Level

Compliance

Level

Electromagnetic Environment

Conducted RF IEC 61000-4-6

Radiated RF IEC 61000-4-3

3 V 150 kHz to 80 MHz

3 V/m 80 kHz to 800 MHz

[V1 =] 3 V

[E1=] 3 V/m

Portable and mobile RF communications equipment are used no closer to any part of the [EQUIPMENT and/or SYSTEM], including cables, than the recommended separation distance calculated from the equation appropriate for the frequency of the transmitter.

Recommended separation distance

d= 1.2

d= 1.2 80 MHz to 800 MHz

d= 2.3 800 MHz to 2,5 GHz

Note: P is the power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).

Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,* are less than the compliance level in each frequency range.**

Interference may occur in the vicinity of equipment marked with the following symbol:

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.

*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 Proteus XR/a system 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]. **Over the frequency range 150 kHz to 80 MHz, field strengths are less than 3 V/m.

The Recommended Separation Distances are listed in the next table.

Note: These are guidelines. Actual conditions may vary.

GE MEDICAL SYSTEMS Operator Manual REV 22 DIRECTION 2259724-100

Guidance and manufacturer’s declaration - Electromagnetic Immunity (2)

ELECTROMAGNETIC COMPATIBILITY (EMC) (CONT.)

PROTEUS XR/a

Frequency of

Transmitter

150KHz to 80 MHz

80 MHz to 800 MHz

800 MHz to 2,5 GHz

Equation

d= 1.2

d= 2.3

Rated Power of

Transmitter

(W)

DISTANCE

(meters)

DISTANCE

(meters)

DISTANCE

(meters)

0.01

0.12

0.23

0.1

0.38

0.73

1.2

2.3

3.8

7.3

100

For transmitters rated at a power not listed above, the 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: These are guidelines. Actual conditions may vary.

GE MEDICAL SYSTEMS Operator Manual REV 22 DIRECTION 2259724-100

Recommended Separation Distances for Portable and Mobile RF Communications Equipment and the Proteus XR/a system

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WARNING

GE MEDICAL SYSTEMS Operator Manual REV 22 DIRECTION 2259724-100

SAFETY

ELECTRIC SHOCK HAZARD! DO NOT REMOVE COVERS OR PANELS. GENERATOR CABINET CONTAINS HIGH VOLTAGE CIRCUITS FOR GENERATING AND CONTROLLING X-RAYS. PREVENT POSSIBLE ELECTRIC SHOCK BY LEAVING COVERS AND PANELS ON THE EQUIPMENT. THERE ARE NO OPERATOR SERVICEABLE PARTS OR ADJUSTMENTS INSIDE THE CABINETS UNDER THE TABLE. ONLY TRAINED AND QUALIFIED PERSONNEL SHOULD BE PERMITTED ACCESS TO THE INTERNAL PARTS OF THIS EQUIPMENT.

FOR CONTINUED SAFE USE OF THIS EQUIPMENT, FOLLOW THE INSTRUCTIONS CONTAINED IN THIS OPERATING MANUAL. STUDY THIS MANUAL CAREFULLY BEFORE USING THE EQUIPMENT AND KEEP IT AT HAND FOR QUICK REFERENCE.

RADIOGRAPHIC EQUIPMENT MUST BE OPERATED BY QUALIFIED PERSONNEL AND ONLY AFTER SUFFICIENT TRAINING.

UNITED STATES FEDERAL LAW RESTRICTS THIS DEVICE TO USE BY OR ON THE

ORDER OF A PHYSICIAN.

IT IS THE RESPONSIBILITY OF THE OPERATOR TO ENSURE THE SAFETY OF THE PATIENT WHILE THE MACHINE IS IN OPERATION BY CHECKING PROPER PATIENT POSITIONING AND USING THE EQUIPMENT PROTECTIVE DEVICES.

TO AVOID INJURY TO FINGERS AND HANDS OF PATIENT AND OPERATOR CAUSED BY TABLE TOP MOVEMENT, HANDS MUST BE KEPT AWAY FROM TABLE TOP EDGES AT ALL TIMES.

USE A SID AS LARGE AS POSSIBLE IN ORDER TO KEEP THE ABSORBED DOSE TO THE PATIENT AS LOW AS REASONABLY ACHIEVABLE.

IT IS THE RESPONSIBILITY OF THE OPERATOR TO PROVIDE MEANS FOR AUDIO AND VISUAL COMMUNICATION WITH THE PATIENT FROM THE CONTROL ROOM.

PERFORM PERIODIC MAINTENANCE TO ENSURE CONTINUED SAFE USE OF THE EQUIPMENT. (See chapter 11 Planned Maintenance).

IF ANY SAFETY PROBLEM OCCURS, PLEASE STOP USING THIS DEVICE AND CONTACT OUR SERVICE AT ONCE.

RESTRICT ACCESS TO THE EQUIPMENT IN ACCORDANCE WITH LOCAL REGULATIONS FOR RADIATION PROTECTION.

TO AVOID THE RISK OF ELECTRIC SHOCK, THIS EQUIPMENT MUST ONLY BE CONNECTED TO A SUPPLY MAINS WITH PROTECTIVE EARTH.

FOR DIAGNOSTIC X-RAY EQUIPMENT SPECIFIED TO BE USED IN COMBINATION WITH ACCESSORIES OR OTHER ITEMS NOT FORMING PART OF THE SAME, PLEAE PAY ATTENTION TO THE POSSIBLE ADVERSE EFFECT ARISING FROM MATERIALS LOCATED IN THE X-RAY BEAM. REFER TO THE TABLE BELOW FOR MAXIMUM ATTENUATION EQUIVALENT OF POSSIBLE MATERIALS LOCATED IN THE X-RAY BEAM.

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CAUTION

GE MEDICAL SYSTEMS Operator Manual REV 22 DIRECTION 2259724-100

Always be alert to safety when you operate this equipment. You must be familiar enough with the equipment to recognize any malfunctions that can be a hazard. If a malfunction occurs or a safety problem is known to exist, do not use this equipment until qualified personnel correct the problem.

Apply necessary sterilization with 75% medical Alcohol to components which are possible to be contacted with the patients, such as Table top, Wall Stand (including SG120 Wall Stand) front panel, etc.

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GE MEDICAL SYSTEMS Operator Manual REV 22 DIRECTION 2259724-100

ENVIRONMENTAL PROTECTION

WITH THE DISPOSAL OF WASTE PRODUCTS, RESIDUES AND EQUIPMENT ACCESSORIES THAT ARE OUT OF THEIR EXPECTED SERVICE LIFE, TO AVOID THE IMPACT OF ENVIRONMENT, PLEASE COMPLY WITH LOCAL STATUTE OR CALL GE SERVICE.

ESTABLISH EMERGENCY PROCEDURES

ESTABLISH PROCEDURES FOR HANDLING THE PATIENT IN CASE OF THE LOSS OF RADIOGRAPHIC IMAGING OR OTHER SYSTEM FUNCTIONS DURING AN EXAM.

POSSIBLE PATIENT INJURY!

TO AVOID POSSIBLE PATIENT INJURY, BE SURE THAT SYSTEM POWER IS APPLIED BEFORE THE PATIENT ENTERS THE ROOM. THE OVER HEAD TUBE SUSPENSION MOVEMENT EM LOCKS AND TABLE LONGITUDINAL TRAVEL LOCKS FUNCTION ONLY WHEN SYSTEM AC POWER IS APPLIED.

IF POWER IS DISCONNECTED, THE OTS AND THE TABLE TOP (LONGITUDINAL) WILL MOVE FREELY, POSSIBLE CAUSING THE PATIENT TO FALL.

 DO NOT ALLOW THE PATIENT TO MOUNT OR DEMOUNT THE SYSTEM.  DO NOT ALLOW THE PATIENT TO USE THE OTS AS A SUPPORT.

OPERATIONAL CHECKS

Be sure the equipment is functioning properly and safely before each examination:

Verify that the following controls are operating correctly:

 Motion controls, and Lock Releases  Audible and visual alarms

Visually inspect the equipment and make sure that:

 Equipment is not damaged or missing parts  All cover panels are in place prior to turning on electrical power (hazardous electrical or

mechanical parts could be exposed).

APPROVED OPERATING PROCEDURES AND ACCESSORIES

Be sure to use the equipment and the approved accessories according to approved operating procedures:

 Perform X-ray tube warm up procedure prior to the exam. Failure to perform this

procedure could damage the X-ray Tube assembly.

 Do not exceed tabletop rating of a 220 kg (484 lbs.) patient. Excessive loading could

damage the tabletop and/or cause the patient to fall.

 Accessories should be properly attached to the table and positioned so as not to

interfere with system motions.

 Avoid unnecessary exposure to radiation. Stay behind the lead glass radiation shield or

lead screen. When in unshielded areas, wear protective apparel such as goggles, lead aprons, and gloves.

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WARNING

GE MEDICAL SYSTEMS Operator Manual REV 22 DIRECTION 2259724-100

PLANNED MAINTENANCE

POSSIBLE PATIENT OR OPERATOR INJURY! TO AVOID POSSIBLE PATIENT OR OPERATOR INJURY, BE SURE TO PERFORM

THE PERIODIC INSPECTIONS AND MAINTENANCE PROVIDED IN THIS DOCUMENT. FAILURE TO PERFORM THESE INSPECTIONS COULD ALLOW DETERIORATING CONDITIONS TO DEVELOP WITHOUT BEING DETECTED. THIS DETERIORATION COULD RESULT IN EQUIPMENT FAILURES WHICH COULD

CAUSE SERIOUS INJURY EQUIPMENT DAMAGE.

RADIATION SAFETY

Always use proper technique factors for each procedure to minimize x-ray exposure and to produce the best diagnostic results. In particular, you must be thoroughly familiar with safety precautions before operating this System.

It is not always possible to determine when some components, such as x-ray tubes, are nearing the end of their operating lives. These components could stop operating during a

patient examination.

KNOW THE EQUIPMENT

Read and understand all the instructions in the operating manuals before attempting to use the product and request training assistance from GE Medical System if needed.

Keep the operating manuals with the equipment at all times and periodically review the procedures and safety precautions.

This system contains operating safeguards to provide maximum safety. Before calling for service, be certain proper operating procedures are being used.

Satisfactory equipment performance requires the use of service personnel specially trained on x-ray apparatus. GE Medical Systems is responsible for the effects on safety, reliability, and performance only if the following conditions are met:

 The electrical wiring of the relevant rooms complies with all national and local codes as well as the Regulations for the electrical equipment of buildings published by the Institution of Electrical Engineers.

 All assembly operations, extensions, re-adjustments, and modifications or repairs are

carried out by GE Medical Systems’ authorized service representatives.

 The equipment is used in accordance with the instructions for use.

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GE MEDICAL SYSTEMS Operator Manual REV 22 DIRECTION 2259724-100

TABLE OF CONTENTS

CHAPTER TITLE PAGE NUMBER

1 QUICK START 1-1

1-1 Turn System On 1-1 1-2 Tube Warm-Up 1-1 1-3 Set Technique APR 1-2 1-4 Set Manual Technique 1-3 1-5 Set AEC Technique 1-4

2 SYMBOLS 2-1

2-1 Special Notices 2-1 2-2 X-ray Tube 2-1 2-3 Power ON and OFF 2-2 2-4 Electrical Type 2-2 2-5 Electrical Current 2-2 2-6 Ground 2-3 2-7 Proteus XR/a Collimator / Eclipse Proteus Collimator 2-3 2-8 Emergency Button 2-3 2-9 Warning Signs and Labels 2-3 2-10 System Labeling 2-5

3 SYSTEM DESCRIPTION 3-1

3-1 System Components/Features 3-1 3-2 HHS Compliance Compatibilities 3-3

4 PROTEUS XR/A SYSTEM START UP AND SHUT DOWN 4-1

4-1 Turn the power on 4-1 4-2 Turn Power off 4-1 4-3 Daily Warm Up Procedures 4-2 4-4 System Status Display 4-2 4-5 Radiography Control Key 4-3

5 PROTEUS XR/A SYSTEM CONSOLE 5-1

5-1 Introduction 5-1 5-2 Procedure Edit 5-9 5-3 Application 5-13

6 PROTEUS XR/A TABLE COMPONENTS 6-1

6-1 Safe Operation Precautions 6-1 6-2 Introduction 6-3 6-3 Table Operation 6-4 6-4 Cassette Tray Operation 6-6

7 PROTEUS XR/A OVERHEAD TUBE SUSPENSION (OTS) 7-1

7-1 Introduction 7-1 7-2 Overhead Rail System 7-1 7-3 Telescopic Column and Carriage 7-2 7-4 X-ray Tube Support 7-4 7-5 OverHead Tube Suspension User Interface 7-6 7-6 Proteus XR/a Automatic Collimator 7-8 7-7 Proteus XR/a Manual Collimator (Optional) 7-14 7-8 Eclipse Proteus Collimator 7-15

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GE MEDICAL SYSTEMS Operator Manual REV 22 DIRECTION 2259724-100

TABLE OF CONTENTS (CONT.)

CHAPTER TITLE PAGE NUMBER

8 PROTEUS XR/A WALL STAND (GPCP No.: 2260354) COMPONENT 8-1

8-1 Introduction 8-1 8-2 Operation 8-3

9 PROTEUS XR/A SG120 WALL STAND (GPCP No.: 2402562) COMPONENT 9-1

9-1 Safe Operation Precautions 9-1 9-2 Introduction 9-2 9-3 Applications 9-4 9-4 Operation 9-4

10 ACCESSORIES 10-1

10-1 Introduction 10-1 10-2 Accessories 10-1

11 PLANNED MAINTENANCE 11-1

11-1 General 11-1 11-2 HHS Testing 11-1 11-3 Qualified Service 11-2 11-4 Periodic Maintenance 11-2 11-5 Recycling 11-5

12 SYSTEM FAULTS 12-1

12-1 Introduction 12-1 12-2 General Trouble Shooting 12-1 12-3 Other Operator Fault Analysis 12-4 12-4 Resetting Faults 12-4

13 PHYSICAL REQUIREMENTS OF ROOM 13-1

13-1 Environmental Requirements/Limitations 13-1 13-2 Equipment Heat output 13-2 13-3 Radiation Protection 13-3

14 SPECIFICATION 14-1

14-1 General System Specifications 14-1 14-2 Table Specifications 14-2 14-3 Generator Specifications 14-3 14-4 System Console Specifications 14-10 14-5 OTS Specifications 14-10 14-6 Collimator Specifications 14-11 14-7 Wall Stand (GPCP No.: 2260354) Specifications 14-14 14-8 SG120 Wall Stand (GPCP No.: 2402562) Specifications 14-15 14-9 X-ray Tube Specifications 14-16 14-10 Printer Specifications 14-18 14-11 Dose/DAP Specifications 14-18

APPENDIX

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REVISION HISTORY

REV DATE TYPE OF MODIFICATION

0 10/01/2000 Initial production Release 1 20/07/2000 Add system function description and system specification 2 05/12/2000 Update OTS user’s interface description 3 01/02/2001 Update the regulatory requirements. 3 01/02/2001 Add a warning to wall stand operators. 3 01/02/2001 Update system labeling. 3 01/02/2001 Add printer information. 3 01/02/2001 Update wall stand illustration. 3 15/02/2001 Add notes. 3 19/02/2001 Add new wall stand. 3 19/02/2001 Add a maintenance item. 3 01/03/2001 Add manufacturer’s name 3 07/03/2001 Add a warning. 4 27/09/2001 Add notes, change specs. 5 14/05/2003 Add description of MX100 X-ray tube and SG100 Wall Stand 6 12/04/2004 Add a caution about the shroud of the elevating table. 7 25/06/2005 Add EMC and WEEE Rules. 7 25/06/2005 Add description of SG120 Wall Stand. 8 05/12/2005 Add description of Eclipse Proteus collimator 8 05/12/2005 Add a warning 9 15/02/2006 Add description of Reciprocating Bucky and AID Ion Chamber. 10 20/06/2006 Update warning label to meet HHS requirements in Chapter 2. 11 08/10/2006 Add mA and mAs 12 12/09/2007 Add Dose and DAP calculation descriptions 12 12/09/2007 Add Hg label description 13 30/01/2008 Add collimator and tube leakage technique factors 13 30/01/2008 Add anti-toe pinch warning during table descending. 14 25/07/2008 Update the table top’s dimensions to 2250mm*880mm in Chapter 6 15 02/06/2009 Add warning label in Chapter 2; Update Table minimum height;

Remove ANTI-TOE-PINCH. 16 11/08/2009 Minor Update; 17 19/08/2011 Revise EMC standard version 18 24/03/2012 Update EU Authorized Representative Contact Information 19 28/05/2012 Update contents according to the 3rd edition IEC60601 standards 20 16/08/2012 Update contents due to the console redesign. 21 01/07/2015 Update “United States Federal law restricts this device to be used by or

on the order of a physician into “Federal law restricts this device to sale

by or on the order of a physician” 22 01/06/2016 Update the cleaning and disinfecting requirement Update the UDI Requirement

PROTEUS XR/a GE MEDICAL SYSTEMS Operator Manual REV 22 DIRECTION 2259724-100

CHAPTER 1 PROTEUS XR/A QUICK START

1-1 Turn System On

1-2 Tube Warm-Up

-Set Technique

-Set Parameters

-Take 2 Exposures 10 sec apart

1-1

PROTEUS XR/a GE MEDICAL SYSTEMS Operator Manual REV 22 DIRECTION 2259724-100

1-3 Set Technique APR

-Select Category

-Select Procedure

-Take Exposure

1-2

PROTEUS XR/a

-Set Technique

-Set Parameters

GE MEDICAL SYSTEMS Operator Manual REV 22 DIRECTION 2259724-100

1-4 Set Manual Technique

-Take Exposure

1-3

PROTEUS XR/a

-Set Parameters

-Set Technique

GE MEDICAL SYSTEMS Operator Manual REV 22 DIRECTION 2259724-100

1-5 Set AEC Technique

-Take Exposure

1-4

PROTEUS XR/a

CAUTION

WARNING

DANGER

Caution advises of an avoidable condition that could cause minor physical injury, or damage to equipment or data.

Warning advises of an avoidable condition that may allow or cause a personal injury or the catastrophic destruction of equipment or data.

Danger advises of an avoidable condition that will cause serious or fatal injury.

Dangerous Voltage. Indicates an avoidable dangerous high voltage hazard.

This symbol on the equipment means that the operating instructions should be consulted to assure safe operation.

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

This product consists of devices that may contain mercury, which must be recycled or disposed of in accordance with local, state, or country laws. (Within this system, the backlight lamps in the monitor display contain mercury.)

Follow instructions for use.

GE MEDICAL SYSTEMS Operator Manual REV 22 DIRECTION 2259724-100

CHAPTER 2 SYMBOLS

Symbols used on this system and in its accompanying documents are shown and explained in this section.

2-1 Special Notices

2-1

PROTEUS XR/a

Power ON switch or switch position that applies mains voltage. Indicated connection to the mains for all mains switches or their positions. This symbol is used in all cases where safety is involved.

Power OFF switch or switch positions that removes mains voltage. Indicated disconnection from the mains for all mains switches or their positions. This symbol is used in all cases where safety is involved.

Type B Equipment. Equipment providing a particular degree of protection again electrical shock regarding leakage current and protective grounding per IEC 601-1.

Alternating Current. Indicates equipment that is suitable for alternating current only.

Direct Current. Indicates equipment that is suitable for direct current only.

X-ray emission. X-ray tube head is emitting X-rays. Take adequate precautions to prevent the possibility of any persons carelessly, unwisely, or unknowingly exposing themselves or others to radiation.

Identifies controls or indicators associated with the selection of a small focal spot or the connection for the corresponding filament.

Identifies controls or indicators associated with the selection of a large focal spot or the connection for the corresponding filament.

GE MEDICAL SYSTEMS Operator Manual REV 22 DIRECTION 2259724-100

2-2 X-ray Tube

2-3 Power ON and OFF

2-4 Electrical Type

2-5 Electrical Current

2-2

PROTEUS XR/a

Proteus XR/a Collimator

Eclipse Proteus Collimator

Functional Earth (ground) Terminal. Terminal directly connected to a point of a measuring supply or control circuit or to a screening part which is intended to be earthen for functional purposes.

Protective Earth (ground). Identifies any terminal that is intended for connection of an external protective conductor to protect against electrical shock in case of a fault.

Control for indicating radiation field by using light.

Immediately removes power from table.

Label for inhibition button

GE MEDICAL SYSTEMS Operator Manual REV 22 DIRECTION 2259724-100

2-6 Ground

2-7 Proteus XR/a Collimator / Eclipse Proteus Collimator

2-8 Emergency Button

2-9 Warning Signs and Labels

Laser Warning

Note: If have, please confirm the collimator and wall stand you’ve chosen

by referring to the next chapter.

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PROTEUS XR/a GE MEDICAL SYSTEMS Operator Manual REV 22 DIRECTION 2259724-100

Table 2-1

MEANINGS OF PROTEUS XR/A SIGNS

Illustration 2-1

PROTEUS XR/A SYSTEM WARNING SIGNS LOCATION

2-4

PROTEUS XR/a

DESIGNATION

System console

Wall Stand

OTS radiographic

suspension (2/3 m)

Cabinet

PART NUMBER

2259976 or 5441870

600-0301

S3918MD/S3918K

2259973

LOCATION of

Name Plate

DESIGNATION

X-ray Tube (RAD-14)

Proteus XR/a

Automatic Collimator

Bucky (L/H)

Jedi Generator

PART NUMBER

2259981

2259298-54

2189553 or

5159516-1

2268970 or

2244165-2

LOCATION of

Name Plate

DESIGNATION

X-ray Tube (MX 100)

Eclipse Proteus

Collimator

SG120 Wall Stand

PART NUMBER

D2301R

2379827

2402562

LOCATION of

Name Plate

GE MEDICAL SYSTEMS Operator Manual REV 22 DIRECTION 2259724-100

2-10 System Labelling

The labels for the Proteus XR/a system are found on the side panel of the Proteus XR/a cabinet. This label includes the CE mark for the entire system. See the following sketch. For other name plate location, see table 2-2.

Table 2-2

PROTEUS XR/a SYSTEM IDENTIFICATION AND COMPLIANCE PLATES

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