GE Medical Systems Information Technologies 5406102 URP Detector UWB Radio PWA and Antenna Module User Manual Optima220 5400222 1EN

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Users Manual

Optima XR220amx X-Ray System 54400222-1EN Rev 1 DRAFT 11092010 1-1

Rev 1 DRAFT 10142010

OptimaTM XR220amx

X-Ray System

Operator Manual

54400222-1EN

Rev 1 DRAFT 11092010

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IMPORTANT!...X-RAY PROTECTION

Optima XR220amx X-Ray System 54400222-1EN Rev 1 DRAFT 11092010 i-i

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 equip-

ment in use.

Although this apparatus incorporates a high degree of protection against x-radiation other than the use-

ful 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 recom-

mendations 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 Inter-

national 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 Com-

pany, Medical Systems Division, its agents, and representatives have no responsibility for injury or dam-

age 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

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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 con-

formity:

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 dis-

continue the product described at any time without notice or obligation.

The original language of this manual is English.

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Contact Information

Optima XR220amx X-Ray System 54400222-1EN Rev 1 DRAFT 11092010 i-iii

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

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Revision History

Revision

Number

Pages

Affected Description of Change

1 DRAFT

21 Oct 2010

All Preliminary Copy

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Chapter 1: Introduction

Optima XR220amx X-Ray System 54400222-1EN Rev 1 DRAFT 11092010 1-1

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 impor-

tant 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 com-

petently 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

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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 prop-

erty 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 cause severe personal injury, death, or substantial

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 con-

sider about a concept or task.

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Chapter 1: Introduction

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Manual Organization

The manual is organized by chapters to provide information about specific functions. The following list

provides an overview of the chapters’ contents.

xChapter 1: Introduction provides basic information about the Operator Manual itself.

xChapter 2: Safety and Regulatory contains the detailed safety information operators and the physi-

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.

xChapter 3: General Information describes features and functions that apply to the whole system:

such as start up, shutdown, and system messages.

xChapter 4: Moving and Positioning

xChapter 5: System Battery Charging

xChapter 6: Quick Steps provides an overview of common tasks.

xChapter 7: System Hardware Overview describes the overall system, hardware, and available acces-

sories.

xChapter 9: Worklist describes the process of adding, deleting, and selecting procedures from the sys-

tem.

xChapter 10: Image Acquisition describes the process of selecting and performing exams.

xChapter 11: Image Viewer describes the features and functions for adjusting and viewing acquired

images.

xChapter 12: Image Management describes the features and functions to find and organize acquired

images and exams.

xChapter 13: Digital Detector describes the advanced digital detector

xChapter 14: Set Preferences describes the features and processes to configure the system.

xChapter 15: Quality Assurance and Maintenance describes the process to conduct checks on the

detector(s) to ensure continued image quality.

xAppendix A: Login Administration describes how to administer the login options of the system, such

as adding and removing users or groups.

xAppendix B: Specifications provides the technical specifications of the system.

xAppendix C: Messages on Display

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Chapter 1: Introduction

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Graphic Conventions and Legends

The table below describes the conventions used when working with menus, buttons, text boxes and key-

board 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

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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.

A single button to start an

exam

Two buttons to select the

focal spot

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 list from a button

Closed

Open

A list from a text box

Closed

Open

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Chapter 1: Introduction

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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.

A tab to move between two screens

Checkbox

Checkboxes indicate selection.

A single checkbox shows that an

option is active.

Multiple checkboxes show that several

options are selected.

A single checkbox Multiple checkboxes

Text box

Text boxes allow information to be

entered using the keyboard.

Text boxes

Table 1-2 Common software user interface controls

Control and Description Examples

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Chapter 2: Safety and Regulatory

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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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Chapter 2: Safety and Regulatory

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The Optima XR220amx is indicated for use on adult and pediatric patients for general-purpose diagnos-

tic 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 environ-

ments. 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 posi-

tion. 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.

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 Reg-

ulations 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 rep-

resentatives. 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

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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 Health-

care 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

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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 equip-

ment 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 medi-

cal electrical equipment.

CAUTION Use only manufacturer recommended equipment and accessories.

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Chapter 2: Safety and Regulatory

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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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Chapter 2: Safety and Regulatory

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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.

Know the Equipment

Read and understand all of the instructions in this Operator Manual before attempting to use the prod-

uct.

IEC Equipment Classifications

This product is a mobile general purpose radiographic x-ray system. The following equipment classifica-

tions are applicable to this product:

xEquipment classification with respect to protection from electric shock: Class I

xDegree of protection from electric shock: Type B

xDegree of protection against ingress of liquids: IPX0

xDegree 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.

xMode of operation: Continuous with intermittent loading

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Chapter 2: Safety and Regulatory

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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 param-

eters.

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 expo-

sures 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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Chapter 2: Safety and Regulatory

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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.

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 inade-

quate 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 radi-

ation which reaches the area of the body on which they are worn, they do provide a reasonable indica-

tion 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

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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

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

low recommended preventative maintenance schedule as outlined in the docu-

mentation 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

Patient Positioning Warnings

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

end of an exam.

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%

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Chapter 2: Safety and Regulatory

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

pulled.

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

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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

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X-ray Tube Operational Symbols

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

tor locations.

System Power On and Reset

The table below describes the power controls of the system.

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.

Table 2-4 Power controls

Symbol Description

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

xON: Green

xSTANDBY: Blue

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Chapter 2: Safety and Regulatory

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Electrical Type

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

Electrical Current

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

your system.

Ground

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

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.

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.

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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Collimator

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

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.

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.

Table 2-7 Ground types

Symbol Description

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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

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

thicker lines.

Indicates the use of laser radiation.

Table 2-8 Collimator descriptions

Symbol Description

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NRTL Listed Label

The Nationally Recognized Testing Laboratory (NRTL) label indicates that the assembly is listed or recog-

nized 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.

System Identification Plate

Figure 2-5 System Identification Plate TBD

Table 2-9 System identification and compliance plates

Component Plate Type

TBD TBD

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Figure 2-6 System Identification Plate (DHHS)

Figure 2-7 System Identification Plate (ETL)

Table 2-10 System Identification Plate

Number Text

1GE Healthcare, LLC

23000 N. Grandview Blvd. Waukesha, WI USA

3System Model Name

4Optima XRxxx

5Model Number

6Class 1

Table 2-11 System Identification Plate (DHHS)

Number Text

1Complies With DHHS Radiation Performance Standards 21 CFR Subchapter J

Table 2-12 System Identification Plate (ETL)

Number Text

1ETL Classified

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X-Ray Tube Identification Plates

Figure 2-8 X-Ray Tube Identification Plate 1 TBD

2Medical Equipment

Table 2-13 X-Ray Tube Identification Plate 1

Number Text

1GE BE Private Ltd

2Model

3Serial Number

4Manufactured

5Focus

6Description

7Tube Insert Maximum Potential Anode to Cathode

8Tube Insert Minimum Filtration:

Aluminum Equivalent at::

9Whitefield, Bangalore-66. Made in India.

Table 2-12 System Identification Plate (ETL)

Number Text

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Figure 2-9 X-Ray Tube Identification Plate 2 TBD

Table 2-14 X-Ray Tube Identification Plate 2

Number Text

1GE BE Private Ltd

2Model

3Serial Number

4Description

5Tube Insert Maximum Potential Anode to Cathode

6Tube Insert Minimum Filtration:

Aluminum Equivalent at::

7Made for: General Electric Company, Milwaukee, Wisconsin

8Whitefield, Bangalore-66. Made in India.

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Collimator Identification Plate

Figure 2-10 Collimator Identification Plate TBD

Table 2-15 Collimator Identification Plate

Number Text

1Model Number

2Serial Number

3(Manufacturer)

4This Product Complies With DHHS Radiation Performance Standards 21 CFR

Subchapter J, Applicable At Date of Manufacture

5Manufactured (Month/Year)

6Filtration

7Localizer Light: TBD

8Made in TBD

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Detector Identification Plates

Figure 2-11 Detector Identification Plate 1 TBD

Table 2-16 Detector Identification Plate 1

Number Text

1Manufactured For

2General Electric Company

Milwaukee, Wisconsin

3by

4Model

5Serial Number

6Manufactured

7Description

8Made In (Name of Country)

9(Month and Year)

10 (Description of Detector)

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Figure 2-12 Detector Identification Plate 2 TBD

Table 2-17 Detector Identification Plate 2

Number Text

1Manufactured for

GE Healthcare by

2Model Number

3Serial Number

4Manufactured

5Description

6(Month and Year)

7(Description of Detector)

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Collimator Label

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Chapter 2: Safety and Regulatory

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Digital Detector Labels

Refer to the Digital Detector chapter for information on the Digital Detector labels.

Regulatory Requirements

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

cause radio frequency interference to other medical and non-medical devices and radio commu-

nications. To provide reasonable protection against such interference, this product complies with

emission limits for Group 1 Class A Medical Devices as stated in EN 60601-1-2. However, there is

no guarantee that interference will not occur in a particular installation.

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

equipment on and off), you (or qualified service personnel) should attempt to correct the problem

using one or more of the following measures:

-Reorient or relocate the affected devices.

-Increase the space separating 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 the service representative for further suggestions.

Note: 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.

Note: To comply with the regulations applicable to an electromagnetic interface for a Group 1 Class A

Medical Device, all interconnect cables to peripheral devices must be shielded and properly

grounded. The use of improperly shielded and grounded cables may result in the equipment

causing radio frequency interference in violation of the European Union Medical Device directive

and Federal Communications Commission regulations.

Note: Do not use devices which intentionally transmit radio frequency (RF) signals (cellular phones,

transceivers, or radio controlled products) in the vicinity of this equipment, as it may cause per-

formance 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 technologists, patients, and other

people who may be around this equipment, to fully comply with the above requirement.

Installation instructions for this device may be found in Optima XR200amx/220amx Installation Manual

5336113-1EN, which is included with this equipment.

This product complies with the following requirements:

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

formity:

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Figure 2-13 CE mark

Disposal of Waste

This symbol indicates that the waste of electrical and electronic equipment must not be disposed as

unsorted municipal waste and must be collected separately. Please contact an authorized representa-

tive of the manufacturer for information concerning the decommissioning of your equipment.

Figure 2-14 Disposal of waste symbol

Battery Disposal

The separate collection symbol is affixed to a battery, or its packaging, to advise you that the battery

must be recycled or disposed of in accordance with local or country laws. The letters below the separate

collection symbol indicate whether certain elements (Pb=Lead, Cd=Cadmium, Hg=Mercury) are con-

tained in the battery. To minimize potential effects on the environment and human health, it is important

that all marked batteries that you remove from the product are properly recycled or disposed.

For information on how the battery may be safely removed from the device, please consult the service

manual or equipment instructions. Information on the potential effects on the environment and human

health of the substances used in batteries is available at this url:

http://www.gehealthcare.com/euen/weee-recycling/index.html

Figure 2-15 Battery Disposal symbol

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Chapter 2: Safety and Regulatory

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Pollution Control Label

The following product pollution control information is provided according to SJ/T11364-2006 Marking for

Control of Pollution caused by Electronic Information Products.

Figure 2-16 Pollution control symbol

This symbol indicates the product contains hazardous materials in excess of the limits established by the

Chinese standard SJ/T11363-2006 Requirements for Concentration Limits for Certain Hazardous Sub-

stances in Electronic Information Products. The number in the symbol is the Environment-friendly Use

Period (EFUP), which indicates the period during which the toxic or hazardous substances or elements

contained in electronic information products will not leak or mutate under normal operating conditions

so that the use of such electronic information products will not result in any severe environmental pollu-

tion, any bodily injury or damage to any assets. The unit of the period is Year.

In order to maintain the declared EFUP, the product shall be operated normally according to the instruc-

tions and environmental conditions as defined in the product manual, and periodic maintenance sched-

ules specified in Product Maintenance Procedures shall be followed strictly.

Consumables or certain parts may have their own label with an EFUP value less than the product. Peri-

odic replacement of those consumables or parts to maintain the declared EFUP shall be done in accor-

dance with the Product Maintenance Procedures.

This product must not be disposed of as unsorted municipal waste, and must be collected separately

and handled properly after decommissioning.

Dose Chart

Use the table below to compare film speed to dose values.

Table 2-18 Dose Chart

Expected receptor Default Dose (μGy) at 80 kVp

is less than: Equivalent Film Speed

16.00 100

12.90 125

10.00 160

8.00 200

6.25 250

5.00 320

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CAUTION Use the largest possible focal spot-to-skin distance to keep the patient absorbed

dose as small as possible.

CAUTION If no technical factors are present in the system for any view, the default settings

are:

– kV = 50

– ma = 100 (fixed setting)

–mAs = .05

These values are placeholders only. No exposures should be made until the user

selects values appropriate for the patient size.

CAUTION This system source assembly is designed to be used with only the Optima

XR220amx tube and collimator. Replacement of either of these components with

different types may render the system non-compliant to applicable radiation

safety standards and regulations.

4.00 400

3.20 500

2.50 640

2.00 800

1.60 1000

Table 2-18 Dose Chart

Expected receptor Default Dose (μGy) at 80 kVp

is less than: Equivalent Film Speed

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Chapter 3: General Information

Optima XR220amx X-Ray System 54400222-1EN Rev 1 DRAFT 11092010 3-1

Chapter 3: General Information

This chapter explains some of the basic operations and features of the Mobile X-ray Unit.

Quick Highlights

User Interface

xOptimized GUI – Technique, image acquisition and display tools in a single integrated user interface:

Image preview display covers over 50% of the screen

xCommonly used tools pallet available in all image processing screens

xEdit/copy exam to reprocess images without additional patient exposures

xReprocessing of images allow multiple “looks” selection with configurable display parameters

xPre-programmed techniques per anatomy and patient size

xImage text annotations are supported with configurable font size for display and print

xUsage reporting tools by individuals and user groups

xSystem Health dashboard for system status

xIndependent system status and system battery charge indicators

Productivity

x“Stand-by” mode eliminates boot up cycles and allows exposure within 25 seconds of system activa-

tion

xExposures can be taken and processed while the unit is plugged in and charging

xSmart Charge automatic charging algorithms allow the system to be re-charged even if batteries are

not fully drained

xSystem can be driven within 4 seconds of activation

Digital Detector

xWireless connectivity from detector to system

xLightweight detector enclosure designed for mobile use, weighs less than 4.5 kg (10lbs) including bat-

tery

xDetector is battery operated with rechargeable and exchangeable batteries – Back-up tether

included

xDetector battery charges automatically while the detector is in the bin

xSystem can be used without the detector for manual film or CR exposures

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Workflow

xModality Perform Procedure Step (MPPS; SPS/PPS configurable)

xAutomated and customizable image transfer to PACS and printers

xWorklist auto-refresh (configurable)

xCan reprocess images post acquisition and during an exam

xMWL remains visible until the next refresh, even if the network connection is lost

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Chapter 13: Digital Detector

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Chapter 13: Digital Detector

This section outlines the basic detector functions, usage, care, and specifications.

Detector Overview

Detector primary functions are:

xTo convert x-ray data into digital image data

xTo transfer the digital data to the system for processing and display

The detector is an x-ray imaging device. It consists of an array of 2024 x 2024 pixels (40.4 x 40.4 cm).

Each pixel is attached to a data acquisition circuit that converts incoming x-ray signal to 14-bit digital

data.

The detector is constructed from a metal case. The front face contains a graphite x-ray imaging window.

The back face contains safety warnings.

Panel

The panel consists of a thin-film amorphous silicon integrated circuit on a glass substrate with a cesium

iodide scintillator. The scintillating material absorbs the x-rays and converts the energy to light. The light

is converted into a charge that is digitized by the detector electronics.

Electronics

The primary function of the readout electronics is to convert the charge into digital image data. This data

is then transmitted to the system through a wireless link or an ethernet connection.

Physical Appearance / Finish

The detector unit is designed to be installable as 1) an external patient access/contact surface and 2) a

non-external patient access/contact surface.

Detector surfaces have been treated with a finish to allow a smooth and easily cleanable surface. Care

shall be taken to protect the surface from scratches.

Nameplates and Markings

A label on the back of the detector contains the GE part number.

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Detector Handling

The device contains sensitive electronics that are susceptible to vibration, shock, drop, and impact.

When handling the device, use the handle and/or use both hands to manipulate the detector into the

correct anatomical position for the exam.

WARNING Do not swing the device into hard surfaces, especially corners, as this may scratch the

cover, create an image quality artifacts, or damage the electronics inside.

Special Instructions if the detector is dropped: Inspect the exterior for any possible cracks. Run

Detector Check to test the detector. It will be clear if the electronics are not functioning. Other possible

failures may include communication problems, image quality degradation, and loss of power. If any or all

of these occur, call your GE Service Representative.

xDo not drop objects onto the detector.

xDo not use the detector as a stretcher to lift a patient.

xDo not drop the detector at any time.

xDo not prop the device on an edge, against wall or bed. Keep detector in cradle, bucky, or other GE-

supplied container.

xDo not place other objects or patients on the detector if it is not on a flat surface, as shown in .

xDo not use unapproved chemical cleaners.

xDo not immerse detector into water or other liquids.

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

xDo not place objects on detector if it is not lying flat

Detector surfaces have been treated with a finish to provide a smooth and easily cleanable surface. Take

care to protect the surface from scratches.

WARNING Extra precautions should be taken if the device will be exposed to excessive amounts

of bodily fluids or liquids.

The detector is designed to prevent some liquids or particulate matter from getting inside the cover. It

can sustain a temporary splash or spray, but it is not designed to be immersed in liquid (not even tempo-

rarily).

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Hardware Overview

Figure 13-1 Front of the Digital Detector

Table 13-1 Front of the Digital Detector

Item Description

1 Handles

2Battery

3 Indicator Lights

4 Pushbutton

5 Detector Active Visible Area (inside the white marks)

6 Antenna (inside the detector)

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Figure 13-2 Labels on the Front of the Digital Detector

Table 13-2 Labels on the Front of the Digital Detector

Figure 13-3 Labels on the Back of the Digital Detector

Table 13-3 Labels on the Back of the Digital Detector

Item Description

1 Centerline

2 Do not defibrillate (IEC 5841 w/line)

3 RF transmitter (IEC 5140)

4 Ths side toward X-ray source (IEC 5338)

Item Description

1 FCC Approval and FCC ID Number (OU5-5406102)

2 Refer to Instructions (ISO 7010-M002)

3 Type B Applied Part (IEC 5840)

4 Do not X-ray this side (IEC 5338 with cross)

5 Maximum applied weight: 110kg (242 lb) concentrated; 160kg (352 lb) distributed

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Figure 13-4 Detector Docking Connector

Table 13-4 Detector Docking Connector

Figure 13-5 Detector Top

Table 13-5 Detector Top

Item Description

1 Detector Docking Connector

Item Description

1 Pushbutton: Push to toggle between normal mode and sleep mode.

2 Indicator Lights

3 Detector ID Insert - See Chapter 14: Set Preferences-Adding A New Detector Identified By Color

and Shape

4Battery

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Battery and Tether Connection

The battery and the tether plug share the same connector. Only one of these can be plugged in at a time.

Figure 13-6 Detector Battery and Tether

Table 13-6 Detector Battery and Tether

Tether

Handling

To ensure maximum tether life, follow these guidelines:

xTreat the tether with care.

xClean the tether regular with an approved chemical. Refer to for more information.

xUntwist the tether periodically. The colored stripe on the tether shows if it is twisted.

xDo not jerk or pull on the tether. For example, do not pull on the tether to free it from under a wheel

(especially if the tether is twisted).

xDo not step on the tether.

xDo not run over the tether with the unit, cart, table or other equipment.

xDo not use the tether as a handle.

5 Battery Latch

Item Description

1 Latch

2Battery

3Tether

Item Description

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xDo not bend or fold the tether sharply, especially at the points where the tether connects to the

detector and to the unit.

Use

The tether should be kept with the mobile system at all times. It can be stored in the storage compart-

ment. Use the tether under these conditions:

xLow Digital Detector battery or no Digital Detector battery. Tether the system to continue imaging.

xConnectivity issues between the Digital Detector and the system. If you lose an image and are unsure

of the reason, you can use the tether to make sure the next image is transferred.

xComplete loss of connectivity between the Digital Detector and the system. You can use the tether

until your Service Engineer can diagnose and repair the problem.

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Detector Grid

The Digital Detector grid is integrated with a holder that fits the detector exactly. The grid fits over the

detector handle and has raised edges to fit around the detector. Once together, you may handle the grid

and detector as one unit.

The arrows on the grid surface show the direction of the grid lines, which run horizontally.

Figure 13-7 Detector Grid

Table 13-7 Detector Grid

The detector automatically detects when the grid is properly in place. If the grid has been improperly

placed on the back of the detector, the detector will not function. The detector reports to the system

when the grid is attached to or detached from the detector.

Grid Attachment

The bottom edge of the detector should be placed into the bottom lip of the grid holder while held in the

vertical position with the carbon graphite cover (on the front of the detector) facing the inside of the grid

holder. Then press the detector into the top edge of the grid holder. Be careful to not pinch your fingers or

clothing when assembling.

While in use, keep a firm grasp on both the grid holder and the detector. The markings for the active area

are clearly shown on the exterior surface of the grid holder.

Grid Handling

The grid is a sensitive device containing delicate mechanical structures. It is made of very thin pieces of

lead (Pb) and interspersed with Aluminum (Al).

xDo not drop the grid.

Item Description

1 Grid (6:1 grid ratio horizontal is standard, 8:1 grid ratio horizontal is optional)

2 Detector

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xDo not allow objects to hit/impact the grid.

xDo not immerse grid in water or other liquid.

xDo not peel labels or vinyl covering.

xInspect the grid for physical damage before use.

xClean the grid regularly (between each patient) with an approved chemical. Refer to for more infor-

mation.

Use

On, Off, and Sleep Modes

Off

The detector only turns off when the Digital Detector battery is removed. There is no OFF button.

Sleep

xWhen the Digital Detector is on, push the black standby button and hold down for four seconds. The

Digital Detector will go into the Sleep Mode. Press for one second to wake up from the sleep mode.

xWhen placed into the bin, the Digital Detector battery will begin charging and the Digital Detector will

go into the Sleep Mode.

xWhen the Digital Detector is in the Sleep Mode, push the black standby button and hold down for one

second. The Digital Detector will automatically wake up and be ready to use for exposures in 10 sec-

onds.

xWhen pulled out of the bin, the Digital Detector will automatically wake up and be ready to use for

exposures in 10 seconds.

Detector Alignment

To aid in proper alignment of the detector with respect to the X-ray source, there are alignment marks

centered on the front side (imaging side) of the detector. The arrow represents the default heads-up dis-

play orientation.

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Indicator LED’s

Figure 13-8 Indicator LED’s

Table 13-8 Indicator LED’s

The various states of the Indicator LED’s are shown in the illustrations below.

Item Description

1 Battery LED’s

xGreen, Green: Battery more than 75% remaining

xOff, Green: Battery remaining between 25% and 75%

xOff, Yellow: Battery remaining between 10% and 25%

xOff, Red: Battery less than 10% remaining

xOff, Off: Detector in sleep mode

2 Wireless Link LED

xGreen: Wireless Link Connected

xRed: No Wireless Link

xOff: Detector in sleep mode

3 Detector LED

xGreen: Detector Ready

xOff: Detector Off (in sleep mode)

xRed: Detector Fault Condition

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Figure 13-9 Battery more than 75% remaining; Wireless link connected; Detector ready

Figure 13-10 Battery remaining between 25% and 75% ; Wireless link connected; Detector ready

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Figure 13-11 Battery remaining between 10% and 25% ; Wireless link connected; Detector ready

Figure 13-12 Battery less than 10% remaining; Wireless link connected; Detector exposure not allowed

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Figure 13-13 Battery more than 50% remaining; No Wireless link; Detector exposure not allowed

Figure 13-14 Detector off (in sleep mode)

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Figure 13-15 Detector fault condition

In this condition the battery LED’s may be lit to show the condition of the battery.

Electro-magnetic Interference

The detector has been designed and tested to meet all IEC regulations in regard to electro-magnetic (EM)

susceptibility (and EMC).

However, there are no regulations for low frequency EM fields. All flat panel detectors have some suscep-

tibility to these EM fields.

This detector is robust to EM fields up to 0.1mG over a broad low frequency range (DC - 250kHz).

It has been found that some common equipment in clinical environments can generate EM fields well

over 0.1mG. Some measurements have shown 4mG field strengths which can cause artifacts on x-ray

images.

EM fields are reduced by the square of the distance between the EM source and the detector. Thus, mov-

ing the EM source twice as far away will reduce the field strength by 4 times.

General suggestions:

xKeep IV pumps, patient monitoring, feeding pumps 1 meter or more away from any detector surface.

xConsider turning off equipment that cannot be moved.

xChange the patient or detector orientation /position to maximize distance from any equipment.

xTurn on the EMI Reduction feature. See the Preferences chapter for information on how to do this.

Possible sources of EM fields:

xIV pumps

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xMonitors

xFeeding pumps

xPatient monitors

xECG equipment

xEMG equipment

xInfusion pumps

xRF ablators

xPowered surgical equipment

xHeaters

xAir conditioners

xRefrigerators

Cleaning

All exterior surfaces—detector, tether, and grid—should be cleaned after each exam.

xThe detector and grid must be allowed to dry before use.

xDo not leave disposable wipes or cleaning cloths on the detector or grid for more than 60 seconds.

xLet the detector dry at least 60 seconds between cleanings.

The following chemicals and products have been tested and approved by GE for cleaning the GE Portable

DR Detector, grid, and tether.

xCidex OPA

xOxivir

xSuper Sani-Cloth Germicidal Wipes

xBleach (50% solution)

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Specifications

Detector Size and Weight

Table 13-9 Detector size and weight specifications

Environmental Contraints

This section describes the environmental conditions that the detector is designed to withstand.

CAUTION Operation or storage outside of these constraints may cause damage to the

detector.

Table 13-10 Environmental Constraints

Item Specification

Overall detector size

• Including handle

• Not including tether

Thickness: 27mm

Width:452mm

Height:580mm

Image Size

The active area of the x-ray panel

2024 x 2024 pixels or 

40.4 x 40.4 cm

Weight

Not including the tether or grid

9.9lbs (without battery)

Battery: 0.38lbs

Item Operating Environment Constraints Non Operating Environment

Constraints

This column contains additional

operating environmental constraints,

within which the subsystem function

and performance capabilities shall be

in compliance.

This column defines additional Non-

operating environmental constraints,

within which the subsystem function

and performance capabilities shall be

in compliance, when returned to the

operational state, within operating

environment conditions.

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Ambient

• Temperature

• Humidity

• Pressure

• External ambient temperature

range: +10 ºC to +30 ºC.

• Rate of temperature change: 

10 ºC per hour

• Ambient humidity range: 10% to

80%, non condensing.

• Rate of humidity change: 30% per

hour.

• Atmospheric pressure (altitude)

range: -400 meters to +3000 meters

relative to sea level.

• External ambient temperature

range: 0ºC to +50 ºC.

• Rate of temperature change: 

20 ºC per hour

• Ambient humidity range: 5% to 95%,

non condensing.

• Rate of humidity change: 30% per

hour.

• Atmospheric pressure (altitude)

range: -100 meters to +15,000

meters relative to sea level (to

support pressurized transport)

Mechanical

Stress & 

Vibration

Forces

The detector assembly shall not be

exposed to operating vibration

spectrum exceeding the following

parameters:

• Type: Random

• Frequency Range: 20 to 350 Hz

• Magnitude: 0.006g2 /Hz at 10-350

• Duration: 8 hours/axis (x, y, z)

The detector assembly shall not be

exposed to non-operating vibration

spectrum exceeding the following

parameters:

• Type: Random

• Frequency Range: 10 to 2000 Hz

• Magnitude: 6 m/s2 RMS or 

0.02g2 /Hz at 10-2000 Hz

• Duration: 15 minutes/axis (x, y, z)

Shipping &

Storage

Environment

Not applicable. The non-operating shipping conditions

shall be -20 to +60 with the detector

and packing.

The shipping container shall protect

the detector from vibration of 2 Grms

for 8 hours in the x, y, and z axes,

random vibration from 10 to 2000 Hz

such that the image quality is not

degraded.

Cargo hold during shipment shall be

within the atmospheric pressure range

of 700-1100hPa

Item Operating Environment Constraints Non Operating Environment

Constraints

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Appendix A: Login Administration

The login feature requires you to login to access the system and can be turned on or off by your administrator

or Field Engineer.

How your site uses this feature depends on if your site has a central user repository to which the system is

connected. Sites with networks are referred to as Enterprise systems, those without are referred to as stand-

alone systems. This feature can be used with either configuration, although some features are more

applicable to enterprise systems.

1. At the login screen, type your assigned login name.

xThis name is assigned by your system administrator.

Note: If you need to log in quickly for emergency purposes only, press [Emergency Login].

Note: Logging off does not prohibit other users from logging in. Logout is designed to protect patient pri-

vacy, not stop approved users from logging in. When you or another user logs back in, the system

returns to its last known state.

2. Press in the Password area and type in your password.

3. Press [Login].

Figure A-1 Login Window

4. To logout of the system, press [Shutdown].

xThe Shutdown window appears.

5. Press [Logout User].

6. Press [OK].

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xThe system logs you out and waits for the next login.

Configure HIPAA (EA3) Properties

After logging in, the component will display the Application Tab. On this tab, you will be able to configure

EA3 application properties.

1. Press [Utilities].

Figure A-2

2. Press Service [Launch] on the System Utilities screen.

Figure A-3 Service Toolbar

3. Select EA3 Admin Browser

Figure A-4 EA3 Admin Browser

xThis brings up the Administration Screen.

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Figure A-5 Administration Tab

4. Enter your Username and Password.

5. Press [Login].

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Figure A-6 Applications Screen

6. Make your desired selections.

xThe following configurations can be made on this tab:

– Enable Authorization - Whether or not to enable authorization. If authorization is enabled, anyone

logging in through EA3 (both local and enterprise users) must have a role. Anyone without a role

will be denied access if authorization is turned on. Note that the role the user has doesn't matter

for logging into EA3 (however, some other EA3 client applications can decide which roles can

– Emergency Logon Allowed - Whether or not to allow emergency access. If EA3 is used in GUI

mode, this decides whether or not to display the Emergency login button. If this is disabled, emer-

gency user access is prevented.

– Emergency Roles - The roles assigned to the emergency user. The defaults allow an admin to

assign a Standard user role, Limited User role, or both roles.

– Inactivity Timeout (minutes) - The amount of time (in minutes) that must elapse without any

mouse/keyboard, etc. activity before a timeout is generated. When a timeout is generated, the

EA3 logon screen is displayed. This value can be any positive integer, or it can be 0. If the value is

0, this indicates NO inactivity timeout (there will never be a timeout event regardless of how much

time has elapsed).

– Display Last Logon Name - Whether or not to display the username of the last user that has

logged in on the EA3 logon screen.

– Administrator Message - Under certain circumstances / error conditions, the user of EA3 is asked

to contact an administrator. This field allows the administrator to specify contact details for him-

self / herself and a custom message.

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– Emergency Prompt - The text that will be displayed to any user logging in as emergency. The user

is asked to enter information (usually their actual user name). This text is the text that will appear

in that prompt for information.

7. Press [Apply Configuration].

xTo make a configuration change, make the necessary changes on the fields, and press the Apply

Configuration button. If there was a problem with making the changes (such as an invalid value or

a problem contacting the back-end Servlet) you will see a message box indicating this error with a

description of the error. If the changes are successful, after the 'Apply Configuration' button is

pressed, then you will see a brief message indicating that the changes were applied in a green

label. If at any time, you want to revert your changes to what is currently saved on the back-end,

you can press the Restore Configuration button. This will undo any changes that you have made

that have not yet been saved by pressing the Apply Configuration Button. (Once you press the

'Apply Configuration' button and get the confirmation label, the changes have been applied).

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Configure Local Users

The second tab on the EA3 Administration Component is the Local Users tab. On this tab, you can add

users, remove users, change user group memberships, change user names, change user passwords, lock

/ unlock users, force users to change their password on next login, etc. Below is a screen-shot of the EA3

Administration Component Local Users Tab:

1. Select the Local Users tab.

Figure A-7 Local Users Tab

2. Select the choices you wish to have selected.

xMax Logon Attempts Before Lock - The number of failed login attempts a user can make before

their account is locked for a certain number of minutes. When a user account is locked, that user

will not be allowed to login, even if they provide the correct username/password combination.

Either the specified time must elapse before the user can login again, or a user with ADMIN role

must login to the EA3 Administration component to unlock the user. Note that locking only applies

to local users (enterprise user locking is managed by the enterprise server)

xMinimum Password Length - The minimum length of a new password for a user. Note that if a pass-

word is below the minimum password length already, setting this value will have no effect on the

password. For example if your password is 8 characters, and someone changes the minimum pass-

word length to 10 characters, the 8 character password is still ok. However, next time the user

changes their password, they will have to choose a password that is 10 characters or greater. Note

that minimum password length only applies to local users (password length restrictions for enter-

prise users are managed by the enterprise server)

xLock Duration (Minutes) - The number of minutes a user stays locked for if they become locked

because of failed login attempts.

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x Apply Configuration - Use the Apply Configuration button to save changes.

xRestore Configuration - Use this button to undo any changes that have not been saved yet. If there

are any errors, you will get a popup box describing the error. If it is successful, you will see a green

label appear with confirmation information.

Note: Users can become locked in one of two ways.

-The user enters too many incorrect passwords. In this case, the user will be locked out for a

certain amount of time, even with a correct password. Once the time has elapsed, the user can

attempt a login again. An administrator can unlock this user before the lock duration time has

elapsed by un checking Locked under the Local User tab when a user is selected.

-The administrator forcefully locks the user account. In this case, the lock duration does not

apply to a user who was forcefully locked by and administrator. They are locked until the

administration unlocks them.

3. Press [Apply Configurations].

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Add a Local User

Once a user is added, it is automatically highlighted in the Local Users list box on the left-hand site, and it

is 'in context'. Once a user is in context, all information and buttons in the center panel (i.e. Username,

Full Name, Roles, Change Name, Change Password, Remove User, Groups list box, Add To Groups Button,

and Remove From Groups button) refer to that user.

1. Press [Add Local User].

xWhen this button is pressed a popup panel is displayed.

2. Enter the new User ID (which must be unique).

3. Enter a Full Name.

4. Enter a Password.

5. Enter the Confirmed Password.

xIf any errors are encountered, you will receive an error messagebox. If you receive the error mes-

sagebox, changes were not committed to the database, and you can correct your errors and try

again. Possible errors that can be encountered when adding a user are:

– User ID already exists in the local user database (Choose a different unique username)

– Password does not meet the minimum length requirements (Choose a longer password)

– Password and Confirm Password box do not match (Make sure the passwords match)

6. Press [Add User].

Figure A-8 Add User Screen

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Change a User Password

You can select a user to be 'in context' by pressing on the user's id in the 'Local Users' list box on the left

side. Only one user can be in context at a time, and if you attempt to choose multiple users, EA3 will

select the top-most user that is selected. Once a user is 'in context', you can make any necessary modifi-

cations to that user.

Note: When you first navigate to the Local Users tab, EA3 will put the first listed local user 'in context'

automatically. If there are no local users then there will be no user in context, and all of the but-

tons in the center panel will be disabled until a user is added.

1. Select User.

2. Press [Change Password].

xThis brings up a popup panel with two textboxes for the password.

3. Make changes to the password.

4. Press [Confirm Change].

xIf you do not want to make the change, simply press Cancel.

xIf the password doesn't meet the minimum length requirements, you will receive an error message-

box. If this occurs, your changes were not saved. Simply make the necessary corrections, and press

Confirm Change again.

Figure A-9 Change Password

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Change a User Full Name

1. Select User.

2. Press [Change Name].

3. Make changes to the name.

4. Press [Confirm Change].

xIf you do not want to make the change, simply press the Cancel button.

Figure A-10 Change Name

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Remove a User

1. Select User.

2. Press [Remove User].

3. Press [Confirm Removal].

xIf you do not want to make the change, simply press the Cancel button.

Figure A-11 Confirm Removal

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Add or Remove a User from a Group

All of the groups to which this user belongs are listed in the Groups list box.

1. Press [Add To Groups] or press [Remove From Groups].

xThis brings up a popup panel that lists all of the groups that this user is eligible to be added to. If

there are no groups that this user is eligible to be added to, you will get an error message box

instead of the popup panel. Once you get the popup panel, simply select all of the groups to which

you want to add this user (you can select as many as you want at one time).

2. Press [Add Membership] or press [Remove Membership].

Figure A-12 Add Groups

Figure A-13 Remove Group

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Change User Roles

Users roles cannot be directly changed from the Local Users panel. Roles are actually associated with

groups, and users belong to groups. In order to change the roles for a user, you must change the roles of

a group to which that user belongs.

Locking / Unlocking a User

Once a user is in context, you can see if the user is locked by looking at the status of the Locked checkbox

in the bottom panel. If this is checked, then the user cannot login even with a correct password.

1. To unlock the user, uncheck the checkbox, and press Apply Configuration button.

2. To lock a user, check the checkbox and press the Apply Configuration button.

Note: If Emergency User is enabled, you can still login through Emergency User while the system is lock.

Force a User to Change Password on Next Login

Often times if you are an administrator, you would like to force a user to change his or her password the

next time they login for security reasons. You can do this using EA3.

1. Select User

2. Check the Change Password on Next Login checkbox in the bottom panel.

xIf this is checked, then the user will be asked to change their password on the next successful login.

Note: Once the user changes the password on the next login the check will be removed from this user.

Some fields may not be selectable if the following conditions occur.

xFor Users:

–Permanent - If a user is permanent, they can never be removed. When a permanent user is in con-

text, the 'Remove User' button will be disabled.

–Content Not Editable - If a user is flagged as this, then their group memberships cannot be

changed. When a 'content not editable' user is in context, the 'Add To Groups', and Remove From

Groups' buttons are disabled.

–Password not changeable - If a user is flagged as this, then the password cannot be changed, and

the 'Change Password' button will be disabled.

xFor Groups:

–Permanent - If a group is permanent, it can never be removed. When a permanent group is in con-

text, the 'Remove Group' button will be disabled.

–Content Not Editable - If a group is flagged as this, then its group members cannot be changed

(neither added nor deleted). When a user belongs to a Content Not Editable group, this user can-

not be removed from the group (therefore, the group name will not show up when you press

'Remove From Group'). When a user does not belong to a Content Not Editable group, this user

cannot be added to the group (therefore, the group will not show up when you press 'Add To

Group').

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–Role Not Editable - If a group is flagged as this, then the Roles associated with that group cannot

be changed. This property itself does not have a direct impact on what you can do on the Local

Users tab.

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Configure Groups

The third tab on the EA3 Administration Component is the Groups tab. On this tab, you can add local groups,

add enterprise groups, remove local groups, remove enterprise groups, change group roles, and change

group memberships.

1. Press [Groups].

Figure A-14 Groups window

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Add a Local Group

1. Press [Add Local Group].

xWhen this button is pressed a popup panel is displayed.

2. Enter the new group's name (which must be unique).

xIf any errors are encountered, you will receive an error message box. If you receive the error mes-

sage box, changes were not saved to the database, and you can correct your errors and try again.

Possible errors that can be encountered when adding a group are:

– Group name already exists in the database

– Application session timeout

xOnce a local group is added, it is automatically highlighted in the Local Groups list box on the left-

hand site, and it is highlighted. Once a group is highlighted, all information and buttons in the cen-

ter panel (i.e. Group Name, Remove Group Button, Roles checkboxes, Apply Roles button, Group

Members list box, Add Membership button, and Remove Membership button) refer to that group.

Figure A-15 Add Group

3. Press [Add Group].

Add a Enterprise Group

Adding an Enterprise group is quite similar to adding a local group.

1. Press [Add Enterprise Group].

2. When this button is pressed a popup panel is displayed.

xIf any errors are encountered, you will receive an error message box. If you receive the error mes-

sage box, changes were not saved to the database, and you can correct your errors and try again.

Possible errors that can be encountered when adding a group are:

– Group name already exists in the database

– Application session timeout

3. Press [Add Group].

xAdding an enterprise group doesn't actually add a group to the Enterprise directory server. What it

does is give EA3 the ability to manage roles for that group, which should already exist on the Enter-

prise directory server. So, for example, if you add a group 'All Employees' as an Enterprise group to

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EA3, and assign that group with the STANDARD role, then any enterprise user that logs in through

EA3 and belongs to the 'All Employees' group will have the STANDARD role.

xYou cannot manage the group memberships for Enterprise groups. This is managed by the direc-

tory server, not EA3. Therefore, whenever an Enterprise group is in context, both the 'Add Member-

ship' and 'Remove Membership' buttons will be blocked out. This doesn't mean that no one belongs

to the Enterprise groups, just that this is managed by the directory server and not EA3.

xOnce an enterprise group is added, it is automatically highlighted in the Enterprise Groups list box

on the left-hand site, and it is 'in context'. Once a group is in context, all information and buttons in

the center panel (i.e. Group Name, Remove Group Button, Roles checkboxes, Apply Roles button,

Group Members list box) refer to that group.

Figure A-16 Add Enterprise Group

Manage a Group

You can select a group to be highlighted by pressing on the group's name in either the 'Local Groups' or

the 'Enterprise Groups' list box on the left side. Only one group can be highlighted at a time, and if you

attempt to choose multiple groups, EA3 will automatically select the top-most group that is selected.

Once a group is highlighted, you can make any necessary modifications to that group.

Note: When you first navigate to the Groups tab, EA3 will put the first listed local group highlighted

automatically. If there are no local groups, then EA3 will put the first listed enterprise group high-

lighted automatically. if there are no local groups or enterprise groups, then there will be no group

highlighted, and all of the buttons in the center panel will be disabled until a group is added.

Remove a Group

1. Once a group is highlighted, press [Remove Group].

xThis brings up a popup panel asking you to confirm the removal of the group.

2. If you want to remove the group, press [Confirm Removal].

xIf you do not want to remove the group, simply press [Cancel].

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Figure A-17 Remove Group

Change Group’s Roles

Once a group is highlighted, check or uncheck the checkboxes for the Roles you want to give to this

group, and press [Apply Roles]. There is a green label confirmation as usual for successfully applied roles.

If there is a failure on the back-end (i.e. a problem writing the roles configuration changes), you will

receive an error message box with information.

Add Memberships

1. Once a group is highlighted, press [Add Membership].

xThis brings up a popup panel that lists all of the users that are eligible to be added to this group. If

there are no users eligible to be added to this group, you will get an error message box instead of

the popup panel. Once you get the popup panel, simply select all of the users that you want to add

to this group (you can select as many as you want at one time).

2. Press [Add Membership].

xIf you do not want to remove the group, simply press [Cancel].

Remove Memberships

1. Once a group is highlighted, press [Remove Membership].

xThis brings up a popup panel that lists all of the users that are eligible to be removed from this

group. If there are no users eligible to be removed from this group, you will get an error message

box instead of the popup panel. Once you get the popup panel, simply select all of the users that

you want to remove from this group (you can select as many as you want at one time).

2. Press [Remove Membership].

xIf you do not want to remove the group, simply press [Cancel].

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Configure Enterprise Tab

The last tab on the EA3 Administration Component is the Enterprise tab. On this tab, you can configure

the properties necessary to make a connection to an Enterprise directory server (i.e. MSAD, Novell, etc.).

The Enterprise Tab is used by the site’s IT (Information Technology) or GE Service personnel. It provides

connectivity to the site’s user database. If you do not have a network established in your hospital or

clinic, this tab will not be used.

Things to consider:

xUtilize the enterprise capability whenever possible.

xMake sure the enterprise groups are granular enough to restrict protocol edit access.

xThe inactivity timeout should be turned on.

1. Press [Enterprise].

Figure A-18 Enterprise Tab

The following configurations can be made on the top box of this tab:

xEnable Enterprise Authentication - Whether or not Enterprise users should be able to log in. If this is

unchecked, only local EA3 users will be able to log in. If this is checked, both local users and enter-

prise EA3 users will be able to log in (although the local EA3 user database will always be tried first).

xCache Enterprise Users - Whether or not Enterprise users should be cached once they successfully

attempts to login again, and for some reason the Enterprise directory server is not available (i.e. net-

work problems), that user will be granted access if they provide the correct password. If this is

unchecked, then an Enterprise user will be denied access in the case that the Enterprise directory

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Optima XR220amx X-Ray System 54400222-1EN Rev 1 DRAFT 11092010 A-20

server cannot be reached. Note that hashed passwords are cached, the actual password is not

cached.

xEnterprise Authentication Latency (Seconds) - The amount of time (in seconds) that the EA3 login pro-

cess should wait for a response from the Enterprise directory server. Often times, there is a network

latency when connecting to servers, and it will be different on different network configurations. If the

amount of time is reached without a response from the directory server, the EA3 login process will

return a failed login. A value of 5 seconds should be enough time to allow a properly configured direc-

tory server to respond, without being too much of an annoyance to the user if the directory server is

down (i.e. they will only have to wait at a maximum 5 seconds for the login attempt to return).

xApplying configuration changes on the Enterprise tab top box are the same as mentioned before for

the Application tab. Use the Apply Configuration button to commit changes, and the Restore Config-

uration button to undo any changes that have not been saved yet. If there are any errors, you will get

a popup box describing the error.

xAdditionally, the actual connection to the Enterprise directory server can be made on this tab. You will

be modifying properties in the lower two boxes of the Enterprise tab

Auto Configuration

1. Press [Auto-detect Server Name].

xThis attempts to lookup the name of Server Name of the directory server.

xIn some environments, EA3 can try to auto-detect the Enterprise Directory Server. This will only work

in some environments (i.e. where DNS allows service lookups). This is just a convenience feature, and

will sometimes return with an alert that the auto-detect could not find the server. It is not an error if

that message is displayed, simply continue with these steps to configure the Server.

2. Enter the Server Name or IP address of the Enterprise directory server that EA3 should connect to, in

the Server Configuration box.

Note: The system must be able to resolve any IP address or server name. This means the system must

either have DNS enabled or the system must have static information in a hosts file (i.e. /etc/hosts).

3. Choose the Authentication type that the directory server supports.

xIf it is a Microsoft Active Directory Server, most likely you need to choose Kerberos. If it is a Novell

eDirectory Server, most likely you need to choose LDAP If you do not know, check with the owner of

the directory server for information.

xIf the enterprise server supports SSL connections, check the 'Use SSL' checkbox.

Note: If you use LDAP authentication without SSL, passwords will be sent in the clear. This is not recom-

mended, and the client is alerted if they attempt to configure this way. With kerberos and non-

SSL, the authentication is encrypted, but the LDAP traffic is not.

4. Press [Test Connection].

xThis tests to see if the machine can connect to the directory server. If the connection is successful,

you will see a label with a 'CONNECTION OK' text next to the Test Connection button.

xIf the connection is not successful, you will see a label with a 'CONNECTION BAD' text next to the

Test Connection button.

xIf the connection is bad, then there is a problem connecting to the directory server.

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Optima XR220amx X-Ray System 54400222-1EN Rev 1 DRAFT 11092010 A-21

xPossible problems are wrong IP/server name or the system does not have DNS running / cannot

resolve the IP address / server name.

xOnce the Test Connection procedure indicates that the connection is good,

5. Select the type of directory server (either Microsoft Active Directory, Novell eDirectory, or orhter).

6. Press [Generate Defaults] button.

xThis should populate the Realm Name, Format, DN, Login Attribute, First Name Attribute, Last

Name Attribute, and Group Attribute fields with default values for that directory server type.

xIf the directory type is MSAD, both the realm name and the DN should be populated. If the directory

type is eDirectory, the realm name will be blank. If you are attempting to configure a directory

server that is not MSAD or Novell eDirectory, the configuration will have to be done manually. You'll

need to get the correct LDAP property information from the owner of the directory server.

xIf this is a non-MSAD, non-eDirectory server, or is a server with a non-default configuration, it is pos-

sible that you may need to change some properties manually. See below for a definition of all of the

properties that you can configure.

7. Enter a username and password of a user that resides on the directory server.

8. Press [Login].

xYou will see login result information in the Login Results section on the bottom of the tab.

xThis will indicate if the login was successful or not.

xAdditionally, it will print out the First Name, Last Name, and any group memberships for the user.

You may get a warning if First Name, Last Name, or Group Memberships were not found.

xGetting this warning means 1 of two things:

xThe LDAP properties are mis-configured (i.e. First Name Attribute, Last Name Attribute, and/or

Group Attribute)

xThe user doesn't have a First Name, Last Name, or any Group Memberships configured on the

Enterprise directory server.

xIf you get these warnings, you may want to talk with the owner of the directory server to make sure

you have everything set up correctly.

xIf the test login succeeded and you are satisfied with the first name, last name, and group member-

ship information, then your Enterprise directory server is properly configured.

9. Press [Apply Configuration].

xThis makes the configuration changes. Just like other tabs in the Administration component, press-

ing Restore Configuration will undo any changed made that have not yet been applied.

Manual Configuration

As mentioned before, if you are connecting to a directory server that is not MSAD or Novell eDirectory, or

the directory server you are connecting to has a custom configuration, you may need manually config-

ure some of the properties. Here are definitions of all of the LDAP configuration properties and what they

do.

xFormat - This is either set to domain or dn. domain is the 'MSAD' way of doing LDAP authentication (i.e

<userId>@<realm name>). dn is the other way of doing LDAP authentication, which eDirectory, and

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Optima XR220amx X-Ray System 54400222-1EN Rev 1 DRAFT 11092010 A-22

most other directory servers use (i.e. loginAttribute=<userId>,<ldap base dn>). If you are connecting

to a non-MSAD directory server, it's pretty safe to say that you should use dn.

xDN - This is the LDAP base DN of the LDAP server to which you are connecting. Usually this is the fully

qualified domain name separated by a bunch of 'DC='. For example, if the fully qualified domain

name of the directory server is 'example.com', it is likely that the DN will be 'DC=example,DC=com'.

xLogin Attribute - This is the LDAP attribute that should be used for the unique identifier of the user.

This is what they will use as their user id to login. On MSAD this is 'sAMAccountName, and on eDirec-

tory, it is usually 'cn'. This should be set to whatever the directory server you are connecting to uses

as a unique identifier.

xFirst Name Attribute - This is the LDAP attribute that should be used for the first name of the user.

xLast Name Attribute - This is the LDAP attribute that should be used for the last name of the user.

xGroup Attribute - This is the LDAp attribute that should be used to find group memberships for the

user. On MSAD, this is 'memberOf'.

Note: EA3 finds all instances of this attribute (not just the first, like it does for other attributes). So if a

user belongs to more than one group, EA3 will find all memberships.

Note: Regarding LDAP parameter configurations, EA3 finds the first instance of the configured attribute

for a user, except for Group Membership. So, if you configure the First Name attribute to be an

attribute that is listed multiple times, EA3 will assume the first one found during an LDAP query is

the correct First Name. For Group Membership, EA3 will find all instances of that attribute.

Field Highlighting for changes

No changes are saved to EA3 on the Administration page unless you press an 'Apply Configuration' but-

ton on the normal tabs or a 'Confirmation' button on a popup panel.

xFor the 'Apply Configuration' buttons, when they are pressed, and successfully commit information to

EA3, you will see a brief (5-second) label appear indicating that the changes have been saved. The

same things happen when you Restore Configuration (e.g. after you made some changes and want

to revert back and you haven't pressed 'Restore Configuration' yet.

Note: If you make changes on one tab (e.g. Application tab), and do not press Apply Configuration, and

then you navigate to another tab, your changes will be lost. The next time you navigate to this

tab, since the changes were never applied, you will see the old configuration. So, after making

changes on a tab, but before navigating to a different tab, you must press Apply Configuration.

Also, there are sometimes more than one Apply Configuration button on a given tab, so make

sure you press the one associated with the data you changed (the buttons are grouped with the

data they manage in a bordered panel).

To help the you understand what fields you may have changed, any changed fields are highlighted with

green text / borders, and the Apply Configuration button that must be pressed in order to commit the

changes. Below in Figure 5-43 is demonstrating field highlighting. You can see that several fields have

changed, and you should press the Apply Configuration button.

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Optima XR220amx X-Ray System 54400222-1EN Rev 1 DRAFT 11092010 A-23

Figure A-19 Highlighted Changes

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Appendix B: Specifications

Optima XR220amx X-Ray System 54400222-1EN Rev 1 DRAFT 11092010 B-1

Appendix B: Specifications

Power

xCapable of 100-240V nominal, 50 /60 Hz operation

xSystem battery status display

System Battery

xIndependent component power management and system battery charging algorithms to maximize

usage time

xSystem Battery charge can take 90 typical exams on a single charge

xMaximum charge time of 4 hours to go from 10-100%

X-ray Tube

X-ray Source

xHeat Storage Capacity

–Anode: TBD Joules (TBD heat units)

–Tube Unit: TBD Joules (TBD heat units)

xMaximum Heat Dissipation Rate

–Maximum anode heat units: TBD

–Maximum Continuous Heat Dissipation: Without Air-circulator: 170W (238 HU/s)

xFocal Spot Sizes 1.3mm/0.6mm

xTarget Angle 12.5°

xAnode Rotation Speed (minimal): 3200/min

xMaximum X-ray Tube Current

–Large Focus: 500 mA

–Small Focus: 200 mA

xNominal Voltage (Radiographic): 40 to 150 kV

xMaximum Voltage:

–Anode to Cathode TBD kVp rectified

–Anode or Cathode to ground TBD kVp

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Appendix B: Specifications

Optima XR220amx X-Ray System 54400222-1EN Rev 1 DRAFT 11092010 B-2

Tube Positioning

xThe column may be rotated up to ± 270° from the park position

xTube Angle display and SID measuring tool

xMaximum focal spot 200cm (78.7 in): Height

xMinimum focal spot 62.5cm (24.6 in): Height

xVertical travel 137.6 cm (54.7 in)

xMinimum horizontal extension center of column rotation to centerline of tube: 70.6 cm (27.8 in)

xMaximum horizontal extension center of column rotation to centerline of tube: 111.8cm (44 in)

xTravel Range of at least 41.2 cm (16.2 in)

High-voltage generator

xPower (kW) 15 standard, 30 optional

xkVp: 50 to 125 in 24 steps (25% up, 20% down)

xmA: 300 maximum

xmAs: 0.2 to 630 in 35 steps

xAllowable tube voltage range deviation: TBD

xLess than 2% low frequency ripple

xFrequency: greater than 100 kHz

xSuper resonant inverter with varying frequency

xMaximum exposure time 6 sec. for film/CR, digital exposures limited to 3.6 sec

xMinimum exposure time: 0.4 msec

Collimator

xA pair of independent collimator blades controls the x-ray field

x180 lux (1000 (Lumen/mt2) light field lamp

xThe collimator rotates +/-180 degrees with detents at -180, -90, 0, +90, and +180 degrees

xFull 43cm x 43cm (17 in) coverage at a 100 cm SID to accommodate Film/CR

xAccessory rail for use with optional Al or Cu spectral filters or optional DAP meter

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Appendix B: Specifications

Optima XR220amx X-Ray System 54400222-1EN Rev 1 DRAFT 11092010 B-3

Digital Detector

Physical Characteristics

xSingle panel (non-tiled) amorphous silicon detector with a Cesium Iodide scintillator

xDetector battery can take up to 45 exposures per hour and provide enough power for 3 hours of use

on a single charge

xDetector can support up to 150Kg (330 lbs) of distributed load for bariatric applications

xIncludes 6:1 removable grid

xIncludes QAP (Quality Assurance Procedure)

xDimensions:

–Length: 23.1 inch (580mm)

–Height: 17.8 inch (452mm)

–Thickness: 0.94 inch (24mm)

xWeight:

–Detector: 4,309 g (9.5 lbs.)

–Battery: 227g (0.5lbs.)

xTether Length: 4m

xImage area: 40.4cm x 40.4cm (15.9inx15.9in)

xActive matrix: 2022 x 2022 pixels

xImage Depth TBD Bit

xRaw Image File Size: 8mb

xPixel Pitch: 200 microns

xTypical Upper Dynamic Range: 7.8mR

xTypical DQE @ 0lp/mm: 68%

Communication

xWireless point-to-point network between the system and detector for transferring image data

xCommunication over wide 500MHz channels to achieve very high data rates

xLow output power to limit range to less than 10 meters to increase safety and spectrum reuse

xDesigned to co-exist with 802.11 networks without interference

xFrequency: 3.168-4.752GHz. Uses Band Group 1.

xMax Power Output: -41.3dBm

xMax PHY Data rate: 480 Mbps

xEffective Throughput: 30-70 Mbps

xStandards: WiMedia PHY spec v1.2, WiMedia MAC spec v1.0, Certified Wireless USB spec v1.0

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Appendix B: Specifications

Optima XR220amx X-Ray System 54400222-1EN Rev 1 DRAFT 11092010 B-4

User Interface

xIntegrated 15 in (38.1 cm) touch-screen user interface

xMonitor matrix size 1024 x 768 pixels

x250GB or greater for storage of more than ~30,000 uncompressed images

xImages can be stored on a CD with the included external CD drive

xUSB outlets for external drive, barcode reader, service mouse and keyboard

Networking and DICOM

Worklist can be retrieved from HIS/RIS systems and images can be transmitted through the DICOM inter-

face to printers, archival devices (PACS), servers or review workstations.

xRJ45 10/100/1000 Base T Ethernet port or optional 802.11 a/b/g/n wireless connection

xIHE and DICOM 3.0 compliant services:

–DICOM IOD generated – DX

–Image auto send/transfer –DX or CR (support multiple destinations)

–DICOM storage – SCU

–DICOM storage commitment SCP, when Fixed IP address is provided (programmable auto-delete

function)

–DICOM modality worklist for HIS/RIS – SCU (with programmable auto refresh)

–DICOM grayscale print – manual and auto (with print layout options)

–Multi-format printing

–DICOM CD-R media exchange (DX only)

–Verification of connectivity for SCU & SCP services

–DICOM Modality Perform Procedure Step (MPPS) feedback to the HIS/RIS (SPS PPS) (configurable)

–VOI LUT burn on send (configurable)

Please refer to DICOM conformance statement for complete definition of supported DICOM services

Drive

xBattery operated

xSelf propelled single drive handle control

xVariable speed of up to 5 km/h (3.1 mph) forward and reverse, automatically adjusts to the operator’s

pace; variable to adjust to the operator’s pace.

xCapable of climbing an incline of 7°

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Appendix B: Specifications

Optima XR220amx X-Ray System 54400222-1EN Rev 1 DRAFT 11092010 B-5

Safety and Compliance

xRoHS Compliant

xDrive Inhibit keypad access for JCAHO compliance

xPassword protected access to patient information for compliance with confidentiality regulations

xAutomatic safety brake: Operator must press drive controls to allow system movement

xIntegrated front bumper stops unit and activates brakes when activated

Mechanical Characteristics

xOverall Width 55.9cm/22in (Includes front bumper)

xOverall Height 194cm/76.4in

xTube Height in Transport (lookover) 138.4cm/54.4in

xLength: 103.5cm/40.8in

xOverall Length 124.6cm/49.1in (includes handle)

xWeight: 499kg/1,100lbs

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Appendix B: Specifications

Optima XR220amx X-Ray System 54400222-1EN Rev 1 DRAFT 11092010 B-6

Environmental Conditions

System

Digital Detector

Temperature

Operating +10° C to +35° C

Non-Operating System (except

Detector)

-10° C to +45° C

Humidity

Operating 30% to 75% RH, non-condensing (maximum change 30% per hour)

Non-Operating 25% to 85% RH, non-condensing (maximum change 30% per hour)

Altitude

Operating -30 m to +3,000 m relative to sea level

Non-Operating -30 m to +3,000 m relative to sea level

Atmosphere Pressure

Operating 106 kPa to 70.1 kPa

Non-Operating 106 kPa to 70 kPa

Audible Noise

Operating 60 dBA maximum audible noise at any point 1 meter from system

Idle 50 dBA maximum audible noise at any point 1 meter from system

Temperature

Operating +10° C to +35° C

Non-Operating 0° C to 50° C (maximum change 50° C per hour)

Humidity

Operating 10% to 80% RH, non-condensing (maximum change 30% per hour)

Non-Operating 10% to 95% RH, non-condensing (maximum change 30% per hour)

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Appendix B: Specifications

Optima XR220amx X-Ray System 54400222-1EN Rev 1 DRAFT 11092010 B-7

Options

x802.11 a/b/h/n - Wireless connectivity to hospital network

–802.11 a/b/g/n

–Wi-Fi Certified

–Compatible with:

x802.11i, Wi-Fi Protected Access 2 (WPA2), WPA

x802.1X

xAES- TKIP

x64-, 128-WEP

xVPN: IPSec –- IKE

xManagement Frame Protection (MFP)

–EAP Types:

xLEAP

xLEAP + 128-WEP

xLEAP + WPA

xEAP-TLS

xEAP-TTLS/MSCHAPv2

xEAP-FAST

xPEAP-GTC

xPEAP/MSCHAPV2 EAP-SIM

x30 kw Generator

–Available 30 kW (nominal) option

xDose Area Product Meter

xSpectral filters

x8:1 Grids

xBarcode reader

xRepeat Reject Analysis software

–Optional Repeat/ Reject Analysis tool allows classification and analysis of Repeated / Rejected

exposures on the system

xAuto Protocol Assist software

–Optional Auto Protocol Assist – matches procedure codes from MWL to select anatomy technique

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Appendix C: Messages On Display

Optima XR220amx X-Ray System 54400222-1EN Rev 1 DRAFT 11092010 C-1

Appendix C: Messages On Display

Two kinds of messages can appear on the message display on the control cover: status messages and

error messages.

Status messages simply inform you of the operating condition of the Definium AMX 700, and look

something like this.

Figure C-1 Ready message

Another type of message, called an error message, may appear should a problem occur with the

equipment. An error message looks something like this.

Figure C-2 Error message

Note that an error message includes an alphanumeric code, and will display one line at a time.

If an error message appears, follow these steps.

1. Try the function again. If the problem is corrected, and no error message is displayed, proceed as

usual.

2. If the error message still displays, turn the unit OFF then back ON.

Diagnostics or self-tests are quickly performed when the unit is turned back on.

When diagnostics are complete, the following message displays:

ERROR XXX

OCCURRED WHEN

THE UNIT WAS

LAST OPERATED –

PROCEED WITH

---CAUTION –

3. Now try the function once more. If the problem is corrected, and no error message is displayed,

proceed as usual.

4. If the problem persists, call your service representative, and report the code and message shown on

the display. This will prepare service for the type of problem encountered and the service required.

Table¬C-1 lists the status messages and provides a brief explanation of each one.

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Appendix C: Messages On Display

Optima XR220amx X-Ray System 54400222-1EN Rev 1 DRAFT 11092010 C-2

Table C-1 Status message descriptions

Status Messages Description

AUTO CAL LIMIT If this message displays, the unit is at its automatic calibration limit. A service

call is recommended to ensure accurate technique and radiographic results.

Exposures are not inhibited.

BATTERY TOO HIGH

VOLTAGE RECOVERY

IS REQUIRED

This message may appear when attempting to take a high technique

exposure immediately after removing the unit from charge. Exposure is

prevented. Operating the field lamp or driving theDefinium AMX 700 will

assist in stabilizing the battery voltage so that the exposure may be made.

BATTERY TOO LOW This message may appear when attempting to expose when only a few

segments remain on the battery charge indicator. This means that the battery

does not contain sufficient charge to make an exposure.

CHARGE REQUIRED Exposure is prevented. Recharging the batteries will eliminate the message

and allow exposures.

CHARGE COMPLETE The charge process is complete, and the battery is fully recharged.

STANDBY The unit is allowing usage for a maximum of 60 minutes (keyswitch is ON and

the unit is plugged in).

CHARGING The unit is charging.

DRIVES ONLY All modes are disabled except drive. Service is required.

HEAT WAIT No exposures can be taken while this message appears (The length of the

delay will vary with the selected technique). This message displays while the

tube anode is cooling.

kVp MAX Displayed on the alphanumeric display any time an attempt is made to

increase the kVp above125.

kVp MIN Displayed on the alphanumeric display any time an attempt is made to

decrease the kVp below 50.

LIGHT DISABLED

FOR COOLING

If the field light is on for over 4 minutes, the light will be automatically turned

off to prevent the collimator from overheating. You may activate the field

light in about 5 minutes.

mAs MAX Displayed on the alphanumeric display any time an attempt is made to

increase the mAs above320 or above the acceptable energy limit for the x-

ray tube anode. The acceptable heat limit is based on the kVp you selected.

Note that the kVp setting will always take precedence over the mAs setting.

That is, if the technique selected would generate too much x-ray tube heat,

the maximum mAs will automatically decrease to permit the selected kVp.

mAs MIN Displayed on the alphanumeric display any time an attempt is made to

decrease the mAs below 0.40.

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Appendix C: Messages On Display

Optima XR220amx X-Ray System 54400222-1EN Rev 1 DRAFT 11092010 C-3

READY FOR X-RAY The prep cycle has successfully completed, and an exposure may be taken

within the next 30 seconds. (If an exposure is attempted after 30 seconds, the

prep cycle must be repeated.)

RECHARGE

IMMEDIATELY X-RAY

INHIBITED

The estimated usable battery capacity is near 0%. No more exposures may

be taken. Although charge is too low to complete an x-ray exam, you’ll have

enough energy to drive the unit to a correctly rated wall outlet for recharge.

RECHARGE

RECOMMENDED

The remaining battery capacity is approximately 10% or less.

RELEASE HANDLE The Definium AMX 700 was moving faster than the drive motors allow.

Release the Drive Handle to clear the message, and then continue with

normal operation. This may happen if you push the Definium AMX 700 too

hard when driving down a ramp.

RELEASE PREP SW The prep switch is still depressed (five seconds after an exposure or beyond

the 30-second timeout). If taking an exposure, repeat the prep cycle: 1)

release the prep switch, and 2) when the message WAIT is no longer

displayed, press to prep position again.

RESET AEC CNTROL Reset the AEC controller. AEC is on, but not enabled. For Example: The (ON)

light is flashing on the Automatic Exposure Control (AEC) unit. This indicates

the paddle is not connected. Reset the AEC controller. The red reset (GEN) on

the Automatic Exposure Control (AEC) unit is lit. This indicates the back-up

time is too short. Reset the AEC controller.

REVERSE ONLY Forward drive is prevented because the safety bumper is in contact with

another object. Reverse the unit before proceeding.

TESTING COMPLETE Power-up diagnostic testing is finished.

WAIT Wait before taking another exposure. (Displayed when the tube anode has

cooled, but before the battery has recovered from the previous exposure.)

Although radiographs can be taken, because of low battery voltage they may

not achieve the desired kVp technique accuracy.

WAIT/ACT-XX.X After an AEC exposure the XX.X field will display the actual exposure mAs.

X-RAY DISABLED This message appears if an attempt to make an exposure occurs while

HEATWAIT is displayed.

X-RAY TUBE PARKED No exposures can be taken with the x-ray tube in the park/transport position.

DETECTOR PARKED Detector is in the holder. Exposures are inhibited

DIGITAL MODE System Software is ready for Digital Radiography procedures

FILM MODE ONLY System can only be used for film procedures

Status Messages Description

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Appendix C: Messages On Display

Optima XR220amx X-Ray System 54400222-1EN Rev 1 DRAFT 11092010 C-4

NO DIG, FILM ONLY System malfunction and can only be used for film procedures

WAIT FOR DIGITAL System software is being loaded. Wait for system to boot completely.

SHUTTING DOWN System PC is shutting down

GOOD-BYE System PC has shut down

NO DIG RESPONSE Digital Radiography components are not responding.

Status Messages Description

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GE Medical Systems Information Technologies 5406102 URP Detector UWB Radio PWA and Antenna Module User Manual Optima220 5400222 1EN

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