GE Medical Systems Information Technologies 5406102 Users Manual

DRAFT REVIEW COPY

Rev 1 DRAFT 10142010

Optima

XR220amx

X-Ray System

Operator Manual

54400222-1EN

Rev 1 DRAFT 11092010

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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 before you attempt to place this equipment in operation. The General Electric Company, Healthcare Division, 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 or his assistant to take adequate precautions to prevent the possibility of authorized or unauthorized persons carelessly, unwisely, or unknowingly exposing themselves or others to direct or secondary radiation.

It is important that everyone having anything to do with x-radiation be 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 Ave., Bethesda, MD 20814, and of the International commission on Radiation Protection, and take adequate steps to insure protection against injury.

It is assumed that all persons authorized to use the equipment are cognizant of the danger of excessive exposure to x-radiation and the equipment is sold with the understanding that the General Electric Company, Medical Systems Division, its agents, and representatives have no responsibility for injury or damage which may result from exposure to x-radiation.

Various protective materials and devices are available. It is urged that such materials and devices be used.

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Medical Device Directive

This product complies with the following requirements:

Council Directive 93/42/EEC concerning medical devices when it bears the following CE marking of conformity:

The location of the CE mark label on the equipment is in the service system manual.

European registered place of business:

GE Healthcare SCS Quality Assurance Manager 283 rue de la Minière 78530 BUC France

Green QSD 1990 Standard issued by MDD (Medical Devices Directorate, Department of Health, UK).

Medical Device Good Manufacturing Practice Manual issued by the FDA (Food and Drug Administration, Department of Health, USA).

Underwriters' Laboratories, Inc. (UL), an independent testing laboratory.

Canadian Standards Association (CSA).

International Electrotechnical Commission (IEC), international standards organization, when applicable.

GE Healthcare reserves the right to make changes in specifications and features shown herein, or discontinue the product described at any time without notice or obligation.

The original language of this manual is English.

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Contact Information

Manufactured by:

GE Healthcare

United States address:

GE Healthcare 3000 N Grandview Ave Waukesha WI 53188-1696 US

Phone number:

United States: 262-544-3011 International: +1-262-544-3011

Web address:

www.gehealthcare.com

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Revision History

Revision Number

1 DRAFT 21 Oct 2010

Pages

Affected

All Preliminary Copy

Description of Change

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Chapter 1: Introduction

The equipment is intended for use by qualified personnel only.

WARNING United States Federal law restricts this device to sale by or on the order of a physi-

cian.

This Operator Manual should be kept with the equipment and be readily available at all times. It is important for you to periodically review the procedures and safety precautions. It is important for you to read and understand the contents of this manual before attempting to use this product.

This chapter explains the purpose and design of this Operator Manual. It provides information on the organization, chapter format, and graphic conventions that identify the visual symbols used throughout the manual.

Purpose Of This Manual

This manual is written for health care professionals (namely, the radiologic technologist) to provide the necessary information relating to the proper operation of this system. The guide is intended to teach you the system components and features necessary to use it to its maximum potential. It is not intended to teach radiology or to make any type of clinical diagnosis.

Prerequisite Skills

This guide is not intended to teach radiology. It is necessary for you to have sufficient knowledge to competently perform the various diagnostic imaging procedures within your modality. This knowledge is gained through a variety of educational methods including clinical working experience, hospital based programs, and as part of many college and university Radiologic Technology programs.

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Chapter 1: Introduction

Safety Information

Please refer to Chapter 2: Safety and Regulatory in this manual. The Safety chapter describes the safety information you and the physicians must understand thoroughly before you begin to use the system. Note that you will find additional safety information throughout your Learning and Reference Guide. If you need additional training, seek assistance from qualified GE Healthcare personnel. The equipment is intended for use by qualified personnel only. This guide should be kept with the equipment and be readily available at all times. It is important for you to periodically review the procedures and safety precautions. It is important for you to read and understand the contents of this guide before attempting to use this product.

Safety Notices

Safety notices are used to emphasize certain safety instructions. This guide uses the international symbol along with the danger, warning, or caution message. This section also describes the purpose of a Note.

DANGER Danger is used to identify conditions or actions for which a specific hazard is

known to exist which will cause severe personal injury, death, or substantial property damage if the instructions are ignored.

WARNING Warning is used to identify conditions or actions for which a specific hazard is

known to exist which may property damage if the instructions are ignored.

CAUTION Caution is used to identify conditions or actions for which a potential hazard may

exist which will or can cause minor personal injury or property damage if the instructions are ignored.

IMPORTANT! An Important comment calls your attention to items that affect your workflow or image

quality but do not involve the safety of people or equipment.

Note: A Note provides additional information that is helpful to you. It may emphasize certain informa-

tion regarding special tools or techniques, items to check before proceeding, or factors to consider about a concept or task.

cause severe personal injury, death, or substantial

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Chapter 1: Introduction

Manual Organization

The manual is organized by chapters to provide information about specific functions. The following list provides an overview of the chapters’ contents.

x Chapter 1: Introduction x Chapter 2: Safety and Regulatory

cians must understand thoroughly before using the system. Note that you will find additional safety information throughout the Operator Manual. If you need additional training, seek assistance from qualified GE Healthcare personnel.

x Chapter 3: General Information

such as start up, shutdown, and system messages.

x Chapter 4: Moving and Positioning x Chapter 5: System Battery Charging x Chapter 6: Quick Steps x Chapter 7: System Hardware Overview

sories.

x Chapter 9: Worklist

tem.

x Chapter 10: Image Acquisition x Chapter 11: Image Viewer

images.

x Chapter 12: Image Management

images and exams.

provides basic information about the Operator Manual itself.

contains the detailed safety information operators and the physi-

describes features and functions that apply to the whole system:

provides an overview of common tasks.

describes the overall system, hardware, and available acces-

describes the process of adding, deleting, and selecting procedures from the sys-

describes the process of selecting and performing exams.

describes the features and functions for adjusting and viewing acquired

describes the features and functions to find and organize acquired

x Chapter 13: Digital Detector x Chapter 14: Set Preferences x Chapter 15: Quality Assurance and Maintenance

detector(s) to ensure continued image quality.

x Appendix A: Login Administration

as adding and removing users or groups.

x Appendix B: Specifications x Appendix C: Messages on Display

describes the advanced digital detector describes the features and processes to configure the system.

describes how to administer the login options of the system, such

provides the technical specifications of the system.

describes the process to conduct checks on the

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Chapter 1: Introduction

Graphic Conventions and Legends

The table below describes the conventions used when working with menus, buttons, text boxes and keyboard keys.

Table 1-1 Conventions for menus, buttons, text boxes, and keyboard keys

Example Describes

Select Marking an option in a group of check boxes or radial buttons

Choosing an option from a drop-down list Activating a tab Highlighting row items

Press [START EXAM] Pressing a button on a screen.

Press ENTER Pressing a key on the keyboard.

Press CTRL+ALT+DELETE Pressing a combination of keys on the keyboard. The key that should be

pressed first is listed first.

Press and hold SHIFT Pressing and holding down a key on the keyboard.

In the Matrix text box,... The name of text box in which you can select or type text or the name of a

drop-down list from which you select an option.

Type DICOMAE in the... Text you enter into a text box.

Select Preferences > Worklist.

The path of selecting option(s) in a tree structure.

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Chapter 1: Introduction

Software User Interface Controls

This manual refers to “controls” that appear on the software screens. The table below describes the most common controls that appear on the software user interface.

Table 1-2 Common software user interface controls

Control and Description Examples

Button

Screen buttons look and act like physical buttons on equipment.

A single button performs a specific action, such as opening a new screen or saving settings.

A group of two or more buttons provides a choice of settings. The dark blue color indicates which button or buttons are selected.

Drop down list

Drop down lists open to reveal several options, but only one option may be selected at a time.

Drop down lists may be included on a button or a text box.

The presence of a drop down list is indicated by a down-pointing arrow on the right side of the control.

A single button to start an exam

A list from a button Closed

Open

Two buttons to select the focal spot

A list from a text box Closed

Open

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Chapter 1: Introduction

Table 1-2 Common software user interface controls

Control and Description Examples

Tab

Tabs are similar to the tabs on file folders. They categorize related information on a single screen.

Pressing on a tab reveals the information related to that tab. Pressing on another tab hides the previous information and reveals a different set of information.

Checkbox

Checkboxes indicate selection. A single checkbox shows that an

option is active. Multiple checkboxes show that several

options are selected.

A tab to move between two screens

A single checkbox Multiple checkboxes

Text box

Text boxes

Text boxes allow information to be entered using the keyboard.

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Chapter 2: Safety and Regulatory

This chapter explains the safety considerations, general equipment and patient related precautions, and the symbols used for the safe operation of your equipment. This chapter also includes information about the emergency procedures.

This chapter presents the concepts necessary to successfully operate your system safely.

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. GE Healthcare, 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 GE Healthcare, 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.

FCC Statement of Conformance

This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.

Indications for Use

The Optima XR220amx is a self-contained, battery-operated mobile radiographic imaging system designed to generate diagnostic radiographic images (medical x-rays) that may increase the ability to detect disease or injury early enough for a medical problem to be managed, treated, or cured.

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The Optima XR220amx is indicated for use on adult and pediatric patients for general-purpose diagnostic radiographic examinations and procedures. Its mobility enables generating radiographic images of human anatomy in all general-purpose x-ray diagnostic procedures within radiology departments, emergency rooms, intensive care units, operating rooms, pediatrics, orthopedics and clinical environments. This may include patients that may not be able to be moved, or in cases where it is unsafe or impractical to move them to a traditional RAD room.

The Optima XR220amx is intended to take exposures utilizing film or CR, however the Optima XR220amx utilizes the GE Universal Radiographic Detector, which is intended to replace radiographic film screen systems in all general purpose diagnostic procedures, for digital radiography (DR). The flat panel detector provides increased functionality to enable images of patients of all sizes, and can produce comparable quality images with as little as half the dose of traditional CR cassettes and other flat panel detectors with lower DQE.

The system is indicated for taking radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts with the patient sitting, standing, or lying in the prone or supine position. The system has medical applications ranging from but not limited to gastrointestinal examinations, cranial, skeletal, thoracic, and lung exposures as well as examination of the urogenital tract.

Chapter 2: Safety and Regulatory

WARNING United States Federal law restricts this device to sale by or on the order of a physi-

cian.

Contraindications

This device is not intended for mammographic applications.

Users

The targeted clinical users include qualified trained doctors, radiographers, or radiologic technologists (RTs) working in various locations. Locations may include orthopedic clinics, radiology imaging centers, hospital radiology departments, or hospital orthopedic departments.

Safety

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, or repairs must be carried out by qualified service representatives. Any modifications must be carried out by GE Healthcare Technologies authorized service representatives. The equipment must be used in accordance with the instructions for use.

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Chapter 2: Safety and Regulatory

WARNING This X-Ray unit may be dangerous to patient and operator, unless safe exposure

factors, operating instructions and maintenance schedules are observed. To be used by authorized personnel only.

WARNING Electric Shock Hazard! Do not remove covers. The system contains high voltage

circuits for generating and controlling X-rays. Prevent possible electric shock by leaving covers on the equipment. There are no operator serviceable parts or adjustments inside. Only trained and qualified personnel should be permitted access to the internal parts of this equipment.

WARNING To avoid the risk of electric shock, this equipment must only be connected to a

supply mains with protective earth.

WARNING All assembly operations, extensions, re-adjustments, or repairs must be carried out by

qualified service representatives. Any modifications must be carried out by GE Healthcare Technologies authorized service representatives.

WARNING Electric shock hazard. To prevent possible electric shock, do not insert fingers

inside the RJ 45 connector (Ethernet port).

WARNING Radiographic equipment must be operated by qualified personnel and only after

sufficient training.

WARNING Do not use in an oxygen-rich environment or around other flammable or explosive

gases.

WARNING This equipment is not rated for use in the presence of flammable gases.

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Chapter 2: Safety and Regulatory

CAUTION 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.

CAUTION This mobile X-ray Unit is not normally connected to protective earth ground while

in use. For the safety of the patient and operator, only devices that are certified to the appropriate safety standards for medical devices and in good working order are to be used in proximity to this X-ray Unit.

CAUTION THIS SYSTEM IS NOT DESIGNED FOR USE IN CLOSE PROXIMITY TO A DEFIBRILLATOR! 



Never use a defibrillator on a patient that remains in contact with the digital detector or any part of the mobile x-ray system. This system must be treated as a conductive surface and moved well away from a patient before defibrillation is attempted. If any part of the mobile x-ray system remains in contact with a patient when the defibrillator is discharged, voltage may be conducted through the patient’s body and into the system. This may be hazardous to anyone who may come in contact with the system, and could damage the detector.



Always consult the instructions for use of any defibrillator that may be used on a patient being imaged by this digital mobile x-ray system.

CAUTION It is the User’s responsibility to provide the means for audio and visual communi-

cation between the Operator and the patient.

CAUTION If you suspect any electromagnetic interference affecting or caused by the unit,

call service. Portable and mobile RF communications equipment can affect medical electrical equipment.

CAUTION Use only manufacturer recommended equipment and accessories.

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Chapter 2: Safety and Regulatory

CAUTION Front bumper will stop movement of the mobile system when engaged. The sys-

tem will stop when the release handle is released.

CAUTION The connection of equipment or transmission networks other than as specified in

these instructions can result in electric shock hazard. Alternate connections will require verification of computability and conformity to IEC/EN 60601-1-1 by installer.

CAUTION Observe equipment limitations when moving the mobile system up or down an

incline.

Figure 2-1 Incline Limits

Good Operating Practices

• Wear a lead apron while performing an x-ray exam.

• Step back at least 6 feet (1.8 meters) from the tube or to the full extension of the hand switch cord before making an exposure.

• Always use the proper field sizes and technic factors for each procedure to minimize x-ray exposure and produce the best diagnostic results.

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• GE Healthcare strongly suggests reducing radiation dose to As Low As Reasonably Achievable (ALARA) in all patients, whenever it is determined that an x-ray exposure is necessary.

• It is recommended that all users receive proper training in applications before performing them in a clinical setting. Please contact the local GE representative for training assistance. ALARA training is provided by GE Application Specialists. The ALARA education program for the clinical end-user covers basic x-ray principles, possible biological effects, ALARA principles, and examples of specific applications of the ALARA principle.

• Check the digital display carefully before making an exposure: verify that the selected technique is the intended technique. Pay particular attention to the placement of the decimal point in the mAs setting to insure that whole numbers are not mistaken for an intended mAs fractional number.

• Ask visitors to step outside the room during an exposure.

• Use gonadal shields for patients whenever possible.

• Be sure to read and follow the maintenance schedule outlined in the Maintenance and Service section of this manual.

• Under most conditions, cumulative radiation dose to the operator will not exceed recommended maximum permissible levels. However, as with all radiation-producing devices, a qualified radiation expert should evaluate situations involving frequent exposures using high kVp and mAs technics to determine if extra protective devices are necessary.

Chapter 2: Safety and Regulatory

Know the Equipment

Read and understand all of the instructions in this Operator Manual before attempting to use the product.

IEC Equipment Classifications

This product is a mobile general purpose radiographic x-ray system. The following equipment classifications are applicable to this product:

x Equipment classification with respect to protection from electric shock: Class I x Degree of protection from electric shock: Type B x Degree of protection against ingress of liquids: IPX0 x Degree of Safety in the presence of Flammable Anesthetics Mixture with air or with oxygen or with

nitrous oxide: Not suitable for use in the presence of Flammable Anesthetics Mixture with air or with oxygen or with nitrous oxide.

x Mode of operation: Continuous with intermittent loading

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Chapter 2: Safety and Regulatory

Electromagnetic Immunity

WARNING Power line anomalies or electrostatic discharges to the system may cause a CD

write failure error. A new CD should be used and the image re-written.

Radiation Safety

Always use the proper technical factors for each procedure to minimize X-ray exposure and to produce the best diagnostic results. In particular, you must be thoroughly familiar with the safety precautions before operating this system. Default techniques are designed to optimize the image processing parameters.

CAUTION There should be no people other than the patient in the room during x-ray expo-

sure. If circumstances require another person to enter the room while x-ray exposures are planned or possible, that person should wear a lead apron in accordance with accepted safety practices.

Radiation Protection

Because exposure to X-ray radiation may be damaging to health, use great care to provide protection against exposure to the primary beam. Some of the effects of X-ray radiation are cumulative and may extend over a period of months or years. The best safety rule for X-ray operator is “Avoid exposure to the primary beam at all times”.

Any object in the path of the primary beam produces secondary (scattered) radiation. The intensity of the secondary radiation is dependent upon the energy and intensity of the primary beam and the atomic number for the object material struck by the primary beam. Secondary radiation may be of greater intensity than that of the radiation reaching the film. Take protective measures to safeguard against it.

An effective protective measure is the use of lead shielding. To minimize dangerous exposure, use such items as lead screens, lead impregnated gloves, aprons, thyroid collars, etc. The lead screen should contain a minimum of 2.0 mm of lead or equivalent and personal protective devices (aprons, gloves, etc.) must contain a minimum of 0.25 mm of lead or equivalent. For confirmation of the local requirements at your site, please refer to your “Local Radiation Protection Rules” as provided by your Radiation Protection Advisor.

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WARNING While operating or servicing x-ray equipment, always keep a distance not less

than 2 meters from the focal spot and X-ray beam, protect body and do not expose hands, wrists, arms or other parts of the body to the primary beam.

Chapter 2: Safety and Regulatory

Monitoring of Personnel

Monitoring of personnel to determine the amount of radiation to which they have been exposed provides a valuable cross check to determine whether or not safety measures are adequate. It may reveal inadequate or improper radiation protection practices and potentially serious radiation exposure situations.

The most effective method of determining whether or not the existing protective measures are adequate is the use of instruments to measure the exposure. These measurements should be taken at all locations where the operator, or any portion of the body may be exposed. Exposure must never exceed the accepted tolerable dose.

A frequently used, but less accurate, method of determining the amount of exposure is the placement of film at strategic locations. After a specified period of time, develop the film to determine the amount of radiation.

A common method of determining whether personnel have been exposed to excessive radiation is the use of personal radiation dosimeters. These consist of X-ray sensitive film or thermoluminescent material enclosed within a holder that may be worn on the body. Even though this device only measures the radiation which reaches the area of the body on which they are worn, they do provide a reasonable indication of the amount of radiation received.

Emergency Procedures

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

WARNING The facility must establish procedures for handling the patient in case of the loss

of radiographic imaging or other system functions during an exam.

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Chapter 2: Safety and Regulatory

Safe Operation Precautions

General Use Warnings

WARNING For continued safe use of this equipment, follow the instructions contained in this

Operator Manual. Study this guide carefully before using the equipment and keep it at hand for quick reference. You may print this manual to have a paper copy available within the Radiology department.

WARNING Only qualified personnel trained in the operation of this equipment should run this

system. Read and become familiar with all instructions in this manual before using this equipment If further assistance is needed, please contact GE.

WARNING It is the responsibility of the owner to make certain that only properly trained, fully

qualified personnel are authorized to operate the equipment. A list of authorized operators should be maintained.

WARNING Check for obstructions before moving the system; do not drive the system into or

onto fixed objects.

WARNING It is the responsibility of the operator to ensure the safety of the patient at all

times. The patient should be monitored by visual observation, use of proper patient positioning, and the use of appropriate protective devices.

CAUTION Keep the patient in full view at all times and never leave the patient unattended.

CAUTION Please carefully monitor all equipment motion to prevent collisions. Pay attention

during operation to prevent possible injuries that could result from collision of the power-driven equipment parts with other moving or stationary items likely to be in the environment.

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Chapter 2: Safety and Regulatory

WARNING Perform periodic maintenance to ensure continued safe use of the equipment. Fol-

low recommended preventative maintenance schedule as outlined in the documentation provided with your system.

CAUTION Make sure any other accessories or materials are not located in the primary X-ray

beam during exposure that could result in bad image quality.

CAUTION Always use GEHC recommended accessories to ensure best performance and to

avoid possible hazards.

WARNING Do not load non-system software onto the system computer.

WARNING For accessories used in combination with diagnostic X-ray equipment, be aware of

the possible adverse effect arising from materials located in the X-ray beam.

Maximum Attenuation Equivalent mm AL or Percent

Item mm Al or Percent

Collimator without spectral filters at 70kV TBD

Permanent tube assembly filtration at 75 kV 0.9mm

Tube housing minimum filtration at 150 kV TBD

Detector Housing at 100 kV TBD

Standard Grid: 6:1 grid ratio horizontal 35%

Optional Grid: 8:1 grid ratio horizontal 35%

Patient Positioning Warnings

CAUTION To avoid patient injury, always assist the patient as needed at the beginning or

end of an exam.

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CAUTION Make sure that patient connected lines, tubes, etc. do not become pinched or

pulled.

Chapter 2: Safety and Regulatory

Digital Detector Warnings

CAUTION Do Not Drop.

CAUTION Device weighs 4,536g (10.0 lbs. with battery).

CAUTION Do not use a defibrillator while patient remains in contact with detector.

CAUTION Maximum load is 110kg (242 lb) concentrated; 160kg (352 lb) distributed. Do not

exceed these maximum load limits.

CAUTION Operate the detector within the temperature range of 10° C to 35° C. Store the

detector within the temperature range of 0° C to 50° C (maximum change 50° C per hour).

Pinch Points and Crush Hazard Summary

This section lists the potential pinch points or crushing hazards that exist for the system.

Table 2-1 Pinch Points and Crush Hazard Summary

Component Warning

System

WARNING Potential Pinch Point: TBD

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Chapter 2: Safety and Regulatory

Symbols

This section explains the symbols used on this system and in its accompanying documents.

Special Notices

Table 2-2 Special notices

Symbol Description

Dangerous voltage. This indicates an avoidable, dangerous, high voltage hazard.

This symbol on the equipment indicates the operating instructions should be consulted to ensure safe operation.

Hand crushing hazard. This symbol indicates that serious injury to the hand may occur.

Follow operating instructions. This symbol directs you to consult this manual for more information.

No stepping or standing on unit. The component on which the symbol appears cannot support the weight of a person. Damage to equipment or injury may occur if the unit is stepped or stood upon.

Maximum load. This symbol indicates that the component has a maximum weight limit. Damage to equipment or injury may occur if the maximum weight is exceeded.

Operating temperature. This symbol indicates that the component must be within a minimum and maximum temperature range in order to operate. Damage to equipment may occur if equipment is used at temperatures outside of the specified range.

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Chapter 2: Safety and Regulatory

X-ray Tube Operational Symbols

The table below describes the operational symbols for the system such as X-ray emissions and collimator locations.

Table 2-3 Operational symbols

Symbol Description

X-ray emission is used to indicate the 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.

X-ray source assembly is used to indicate a reference to an X-ray source assembly.

X-ray tube is used to indicate a reference to the X-ray tube, e.g., to mark the surface of a grid, which is to be oriented towards the X-ray tube.

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 .

System Power On and Reset

The table below describes the power controls of the system.

Table 2-4 Power controls

Symbol Description

The POWER ON button is used to turn on the power to the system.

x ON: Green x STANDBY: Blue

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Chapter 2: Safety and Regulatory

Electrical Type

The table below describes the electrical protection rating based on system type.

Table 2-5 Electrical type

Symbol Description

Type B Equipment indicates the equipment provides a particular degree of protection against electrical shock regarding leakage current and protective earthing per IEC60601-1.

Electrical Current

The table below describes the symbols for the different types of electrical current that may be used on your system.

Table 2-6 Electrical current types

Symbol Description

Alternating Current indicates the equipment is suitable for alternating current only.

Direct Current indicates the equipment is suitable for direct current only.

Both direct and alternating currents indicate the equipment is suitable for both direct and alternating current.

Ground

The table below describes the different types of grounding that may be used in your system.

Table 2-7 Ground types

Symbol Description

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

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Table 2-7 Ground types

Symbol Description

Noiseless (clean) earth (ground) identifies any terminal of a specially designed earthing system where noise from earth of leads will not cause a malfunction of the equipment.

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

Frame or chassis identify the frame or chassis terminal.

Equipotentiality identifies terminals that bring the various parts of equipment or systems to the same potential when connected together. These terminals are not necessarily at earth (ground) potential. The value of the potential may be indicated next to the symbol.

Chapter 2: Safety and Regulatory

Collimator

The table below describes the collimator controls and the radiation field.

Table 2-8 Collimator descriptions

Symbol Description

Control for indicating radiation field by using light.

Identifies controls for opening the collimator blades, or indicates partially or fully open state.

Identifies controls for closing the collimator blades, or indicates closed state.

Indicates the collimator blades are closed. The controlled blades are shown in thicker lines.

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Table 2-8 Collimator descriptions

Symbol Description

Indicates the collimator blades are open. The controlled blades are shown in thicker lines.

Indicates the use of laser radiation.

Chapter 2: Safety and Regulatory

Identification and Compliance Plates

Product identification labels can be found on the system. The types of system identification compliance plates are located in the table below.

Identification Plate

Figure 2-2 Typical identification plate

Figure 2-3 Typical identification plate

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DRAFT REVIEW COPY

Chapter 2: Safety and Regulatory

NRTL Listed Label

The Nationally Recognized Testing Laboratory (NRTL) label indicates that the assembly is listed or recognized by a nationally recognized testing laboratory (i.e. ETL, UL, CSA)

Figure 2-4 ETL Listed Label

Identification and Compliance Plate Locations

The table below identifies the type of compliance plates and their location on your system.

Table 2-9 System identification and compliance plates

Component Plate Type

TBD TBD

System Identification Plate

Figure 2-5 System Identification Plate TBD

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GE Medical Systems Information Technologies 5406102 Users Manual

Specifications and Main Features

Frequently Asked Questions

User Manual