DRAFT REVIEW COPY Rev 1 DRAFT 10142010 OptimaTM XR220amx X-Ray System Operator Manual 54400222-1EN Rev 1 DRAFT 11092010 © 2010 General Electric Company. All rights reserved. Optima XR220amx X-Ray System Operator Manual 54400222-1EN Rev 1 DRAFT 11092010 © 2010 General Electric Company. All rights reserved.
DRAFT REVIEWPROTECTION COPY IMPORTANT!...X-RAY IMPORTANT!...X-RAY PROTECTION X-Ray equipment if not properly used may cause injury. Accordingly the instructions herein contained should be thoroughly read and understood before you attempt to place this equipment in operation. The General Electric Company, Healthcare Division, will be glad to assist and cooperate in placing this equipment in use.
DRAFT REVIEW COPY Medical Device Directive Medical Device Directive This product complies with the following requirements: Council Directive 93/42/EEC concerning medical devices when it bears the following CE marking of conformity: The location of the CE mark label on the equipment is in the service system manual.
DRAFT REVIEW COPY Contact Information 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 Optima XR220amx X-Ray System Operator Manual 54400222-1EN Rev 1 DRAFT 11092010 © 2010 General Electric Company. All rights reserved.
DRAFT REVIEW COPY Revision History Revision History Revision History Revision Number 1 DRAFT 21 Oct 2010 Pages Affected All Optima XR220amx X-Ray System Operator Manual Description of Change Preliminary Copy 54400222-1EN Rev 1 DRAFT 11092010 © 2010 General Electric Company. All rights reserved.
DRAFT REVIEW COPY Chapter 1: Introduction 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 physician. This Operator Manual should be kept with the equipment and be readily available at all times. It is important for you to periodically review the procedures and safety precautions.
DRAFT REVIEW COPY Chapter 1: Introduction Safety Information Please refer to Chapter 2: Safety and Regulatory in this manual. The Safety chapter describes the safety information you and the physicians must understand thoroughly before you begin to use the system. Note that you will find additional safety information throughout your Learning and Reference Guide. If you need additional training, seek assistance from qualified GE Healthcare personnel.
DRAFT REVIEW COPY Chapter 1: Introduction Manual Organization The manual is organized by chapters to provide information about specific functions. The following list provides an overview of the chapters’ contents. x Chapter 1: Introduction provides basic information about the Operator Manual itself. x Chapter 2: Safety and Regulatory contains the detailed safety information operators and the physicians must understand thoroughly before using the system.
DRAFT REVIEW COPY Chapter 1: Introduction Graphic Conventions and Legends The table below describes the conventions used when working with menus, buttons, text boxes and keyboard keys. Table 1-1 Conventions for menus, buttons, text boxes, and keyboard keys Example Select Describes 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.
DRAFT REVIEW COPY Chapter 1: Introduction Software User Interface Controls This manual refers to “controls” that appear on the software screens. The table below describes the most common controls that appear on the software user interface.
DRAFT REVIEW COPY Chapter 1: Introduction Table 1-2 Common software user interface controls Control and Description Tab Examples A tab to move between two screens Tabs are similar to the tabs on file folders. They categorize related information on a single screen. Pressing on a tab reveals the information related to that tab. Pressing on another tab hides the previous information and reveals a different set of information. Checkbox A single checkbox Multiple checkboxes Checkboxes indicate selection.
DRAFT Chapter 2: REVIEW Safety and COPY Regulatory 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.
DRAFT Chapter 2: REVIEW Safety and COPY Regulatory The Optima XR220amx is indicated for use on adult and pediatric patients for general-purpose diagnostic radiographic examinations and procedures. Its mobility enables generating radiographic images of human anatomy in all general-purpose x-ray diagnostic procedures within radiology departments, emergency rooms, intensive care units, operating rooms, pediatrics, orthopedics and clinical environments.
DRAFT Chapter 2: REVIEW Safety and COPY Regulatory WARNING This X-Ray unit may be dangerous to patient and operator, unless safe exposure factors, operating instructions and maintenance schedules are observed. To be used by authorized personnel only. WARNING Electric Shock Hazard! Do not remove covers. The system contains high voltage circuits for generating and controlling X-rays. Prevent possible electric shock by leaving covers on the equipment.
DRAFT Chapter 2: REVIEW Safety and COPY Regulatory CAUTION Always be alert to safety when you operate this equipment. You must be familiar enough with the equipment to recognize any malfunctions that can be a hazard. If a malfunction occurs or a safety problem is known to exist, do not use this equipment until qualified personnel correct the problem. CAUTION This mobile X-ray Unit is not normally connected to protective earth ground while in use.
DRAFT Chapter 2: REVIEW Safety and COPY Regulatory CAUTION Front bumper will stop movement of the mobile system when engaged. The system 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.
DRAFT Chapter 2: REVIEW Safety and COPY Regulatory • 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.
DRAFT Chapter 2: REVIEW Safety and COPY Regulatory Electromagnetic Immunity WARNING Power line anomalies or electrostatic discharges to the system may cause a CD write failure error. A new CD should be used and the image re-written. Radiation Safety Always use the proper technical factors for each procedure to minimize X-ray exposure and to produce the best diagnostic results. In particular, you must be thoroughly familiar with the safety precautions before operating this system.
DRAFT WARNING Chapter 2: REVIEW Safety and COPY Regulatory 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.
DRAFT Chapter 2: REVIEW Safety and COPY Regulatory Safe Operation Precautions General Use Warnings WARNING For continued safe use of this equipment, follow the instructions contained in this Operator Manual. Study this guide carefully before using the equipment and keep it at hand for quick reference. You may print this manual to have a paper copy available within the Radiology department. WARNING Only qualified personnel trained in the operation of this equipment should run this system.
DRAFT Chapter 2: REVIEW Safety and COPY Regulatory WARNING Perform periodic maintenance to ensure continued safe use of the equipment. Follow recommended preventative maintenance schedule as outlined in the documentation provided with your system. CAUTION Make sure any other accessories or materials are not located in the primary X-ray beam during exposure that could result in bad image quality. CAUTION Always use GEHC recommended accessories to ensure best performance and to avoid possible hazards.
DRAFT CAUTION Chapter 2: REVIEW Safety and COPY Regulatory 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.
DRAFT Chapter 2: REVIEW Safety and COPY Regulatory Symbols This section explains the symbols used on this system and in its accompanying documents. Special Notices Table 2-2 Special notices Symbol Description Dangerous voltage. This indicates an avoidable, dangerous, high voltage hazard. This symbol on the equipment indicates the operating instructions should be consulted to ensure safe operation. Hand crushing hazard. This symbol indicates that serious injury to the hand may occur.
DRAFT Chapter 2: REVIEW Safety and COPY Regulatory X-ray Tube Operational Symbols The table below describes the operational symbols for the system such as X-ray emissions and collimator locations. Table 2-3 Operational symbols Symbol Description X-ray emission is used to indicate the X-ray tube head is emitting X-rays. Take adequate precautions to prevent the possibility of any persons carelessly, unwisely, or unknowingly exposing themselves or others to radiation.
DRAFT Chapter 2: REVIEW Safety and COPY Regulatory Electrical Type The table below describes the electrical protection rating based on system type. Table 2-5 Electrical type Symbol Description Type B Equipment indicates the equipment provides a particular degree of protection against electrical shock regarding leakage current and protective earthing per IEC60601-1. Electrical Current The table below describes the symbols for the different types of electrical current that may be used on your system.
DRAFT Chapter 2: REVIEW Safety and COPY Regulatory Table 2-7 Ground types Symbol Description Noiseless (clean) earth (ground) identifies any terminal of a specially designed earthing system where noise from earth of leads will not cause a malfunction of the equipment. Protective earth (ground) identifies any terminal which is intended for connection of an external protective conductor to protect against electrical shock in case of a fault. Frame or chassis identify the frame or chassis terminal.
DRAFT Chapter 2: REVIEW Safety and COPY Regulatory Table 2-8 Collimator descriptions Symbol Description Indicates the collimator blades are open. The controlled blades are shown in thicker lines. Indicates the use of laser radiation. 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.
DRAFT Chapter 2: REVIEW Safety and COPY Regulatory NRTL Listed Label The Nationally Recognized Testing Laboratory (NRTL) label indicates that the assembly is listed or recognized by a nationally recognized testing laboratory (i.e. ETL, UL, CSA) Figure 2-4 ETL Listed Label Identification and Compliance Plate Locations The table below identifies the type of compliance plates and their location on your system.
DRAFT Chapter 2: REVIEW Safety and COPY Regulatory Table 2-10 System Identification Plate Number Text 1 GE Healthcare, LLC 2 3000 N. Grandview Blvd.
DRAFT Chapter 2: REVIEW Safety and COPY Regulatory Table 2-12 System Identification Plate (ETL) Number 2 Text Medical Equipment X-Ray Tube Identification Plates Figure 2-8 X-Ray Tube Identification Plate 1 TBD Table 2-13 X-Ray Tube Identification Plate 1 Number Text 1 GE BE Private Ltd 2 Model 3 Serial Number 4 Manufactured 5 Focus 6 Description 7 Tube Insert Maximum Potential Anode to Cathode 8 Tube Insert Minimum Filtration: Aluminum Equivalent at:: 9 Whitefield, Bangalore-66.
DRAFT Chapter 2: REVIEW Safety and COPY Regulatory Figure 2-9 X-Ray Tube Identification Plate 2 TBD Table 2-14 X-Ray Tube Identification Plate 2 Number Text 1 GE BE Private Ltd 2 Model 3 Serial Number 4 Description 5 Tube Insert Maximum Potential Anode to Cathode 6 Tube Insert Minimum Filtration: Aluminum Equivalent at:: 7 Made for: General Electric Company, Milwaukee, Wisconsin 8 Whitefield, Bangalore-66. Made in India.
DRAFT Chapter 2: REVIEW Safety and COPY Regulatory Collimator Identification Plate Figure 2-10 Collimator Identification Plate TBD Table 2-15 Collimator Identification Plate Number Text 1 Model Number 2 Serial Number 3 (Manufacturer) 4 This Product Complies With DHHS Radiation Performance Standards 21 CFR Subchapter J, Applicable At Date of Manufacture 5 Manufactured (Month/Year) 6 Filtration 7 Localizer Light: TBD 8 Made in TBD Optima XR220amx X-Ray System Operator Manual 54400222-1EN
DRAFT Chapter 2: REVIEW Safety and COPY Regulatory Detector Identification Plates Figure 2-11 Detector Identification Plate 1 TBD Table 2-16 Detector Identification Plate 1 Number Text 1 Manufactured For 2 General Electric Company Milwaukee, Wisconsin 3 by 4 Model 5 Serial Number 6 Manufactured 7 Description 8 Made In (Name of Country) 9 (Month and Year) 10 (Description of Detector) Optima XR220amx X-Ray System Operator Manual 54400222-1EN Rev 1 DRAFT 11092010 © 2010 General Elect
DRAFT Chapter 2: REVIEW Safety and COPY Regulatory Figure 2-12 Detector Identification Plate 2 TBD Table 2-17 Detector Identification Plate 2 Number Text 1 Manufactured for GE Healthcare by 2 Model Number 3 Serial Number 4 Manufactured 5 Description 6 (Month and Year) 7 (Description of Detector) Optima XR220amx X-Ray System Operator Manual 54400222-1EN Rev 1 DRAFT 11092010 © 2010 General Electric Company. All rights reserved.
DRAFT Chapter 2: REVIEW Safety and COPY Regulatory Collimator Label Optima XR220amx X-Ray System Operator Manual 54400222-1EN Rev 1 DRAFT 11092010 © 2010 General Electric Company. All rights reserved.
DRAFT Chapter 2: REVIEW Safety and COPY Regulatory 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 communications.
DRAFT Chapter 2: REVIEW Safety and COPY Regulatory 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 representative of the manufacturer for information concerning the decommissioning of your equipment.
DRAFT Chapter 2: REVIEW Safety and COPY Regulatory 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.
DRAFT Chapter 2: REVIEW Safety and COPY Regulatory Table 2-18 Dose Chart Expected receptor Default Dose (μGy) at 80 kVp is less than: Equivalent Film Speed 4.00 400 3.20 500 2.50 640 2.00 800 1.60 1000 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 = .
DRAFT REVIEW COPY Chapter 3: General Information Chapter 3: General Information This chapter explains some of the basic operations and features of the Mobile X-ray Unit.
DRAFT REVIEW COPY Chapter 3: General Information Workflow x Modality Perform Procedure Step (MPPS; SPS/PPS configurable) x Automated and customizable image transfer to PACS and printers x Worklist auto-refresh (configurable) x Can reprocess images post acquisition and during an exam x MWL remains visible until the next refresh, even if the network connection is lost Optima XR220amx X-Ray System Operator Manual 54400222-1EN Rev 1 DRAFT 11092010 © 2010 General Electric Company.
DRAFT REVIEW COPY Chapter 13: Digital Detector Chapter 13: Digital Detector This section outlines the basic detector functions, usage, care, and specifications. Detector Overview Detector primary functions are: x To convert x-ray data into digital image data x To 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).
DRAFT REVIEW COPY Chapter 13: Digital Detector 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.
DRAFT REVIEW COPY Chapter 13: Digital Detector Hardware Overview Figure 13-1 Front of the Digital Detector Table 13-1 Front of the Digital Detector Item Description 1 Handles 2 Battery 3 Indicator Lights 4 Pushbutton 5 Detector Active Visible Area (inside the white marks) 6 Antenna (inside the detector) Optima XR220amx X-Ray System Operator Manual 54400222-1EN Rev 1 DRAFT 11092010 © 2010 General Electric Company. All rights reserved.
DRAFT REVIEW COPY Chapter 13: Digital Detector Figure 13-2 Labels on the Front of the Digital Detector Table 13-2 Labels on the Front 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) 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 FCC Approval and FCC ID Number (OU5-5406102) 2 Refer to Instruction
DRAFT REVIEW COPY Chapter 13: Digital Detector Figure 13-4 Detector Docking Connector Table 13-4 Detector Docking Connector Item 1 Description Detector Docking Connector Figure 13-5 Detector Top Table 13-5 Detector Top Item Description 1 Pushbutton: Push to toggle between normal mode and sleep mode.
DRAFT Item 5 REVIEW COPY Chapter 13: Digital Detector Description Battery Latch 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 Item Description 1 Latch 2 Battery 3 Tether Tether Handling To ensure maximum tether life, follow these guidelines: x Treat the tether with care. x Clean the tether regular with an approved chemical.
DRAFT x REVIEW COPY Chapter 13: Digital Detector Do 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 compartment. Use the tether under these conditions: x Low Digital Detector battery or no Digital Detector battery. Tether the system to continue imaging. x Connectivity issues between the Digital Detector and the system.
DRAFT REVIEW COPY Chapter 13: Digital Detector 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.
DRAFT REVIEW COPY Chapter 13: Digital Detector x Do not allow objects to hit/impact the grid. x Do not immerse grid in water or other liquid. x Do not peel labels or vinyl covering. x Inspect the grid for physical damage before use. x Clean the grid regularly (between each patient) with an approved chemical. Refer to for more information. Use On, Off, and Sleep Modes Off The detector only turns off when the Digital Detector battery is removed. There is no OFF button.
DRAFT REVIEW COPY Chapter 13: Digital Detector Indicator LED’s Figure 13-8 Indicator LED’s Table 13-8 Indicator LED’s Item 1 Description Battery LED’s x Green, Green: Battery more than 75% remaining x Off, Green: Battery remaining between 25% and 75% x Off, Yellow: Battery remaining between 10% and 25% x Off, Red: Battery less than 10% remaining x Off, Off: Detector in sleep mode 2 Wireless Link LED x Green: Wireless Link Connected x Red: No Wireless Link x Off: Detector in sleep mode 3 Detector LED
DRAFT REVIEW COPY Chapter 13: Digital Detector 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 Optima XR220amx X-Ray System Operator Manual 54400222-1EN Rev 1 DRAFT 11092010 © 2010 General Electric Company. All rights reserved.
DRAFT REVIEW COPY Chapter 13: Digital Detector 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 Optima XR220amx X-Ray System Operator Manual 54400222-1EN Rev 1 DRAFT 11092010 © 2010 General Electric Company. All rights reserved.
DRAFT REVIEW COPY Chapter 13: Digital Detector Figure 13-13 Battery more than 50% remaining; No Wireless link; Detector exposure not allowed Figure 13-14 Detector off (in sleep mode) Optima XR220amx X-Ray System Operator Manual 54400222-1EN Rev 1 DRAFT 11092010 © 2010 General Electric Company. All rights reserved.
DRAFT REVIEW COPY Chapter 13: Digital Detector 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 susceptibility to these EM fields.
DRAFT x Monitors x Feeding pumps x Patient monitors x ECG equipment x EMG equipment x Infusion pumps x RF ablators x Powered surgical equipment x Heaters x Air conditioners x Refrigerators REVIEW COPY Chapter 13: Digital Detector Cleaning All exterior surfaces—detector, tether, and grid—should be cleaned after each exam. x The detector and grid must be allowed to dry before use. x Do not leave disposable wipes or cleaning cloths on the detector or grid for more than 60 seconds.
DRAFT REVIEW COPY Chapter 13: Digital Detector Specifications Detector Size and Weight Table 13-9 Detector size and weight specifications 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 9.9lbs (without battery) Weight Not including the tether or grid Battery: 0.
DRAFT REVIEW COPY Chapter 13: Digital Detector Non Operating Environment Constraints Item Operating Environment Constraints 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.
DRAFT COPY Appendix A:REVIEW Login Administration Appendix A: Login Administration Login and Logout 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 standalone systems.
DRAFT COPY Appendix A:REVIEW Login Administration x The 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 x This brings up the Administration Screen.
DRAFT COPY Appendix A:REVIEW Login Administration Figure A-5 Administration Tab 4. Enter your Username and Password. 5. Press [Login]. Optima XR220amx X-Ray System Operator Manual 54400222-1EN Rev 1 DRAFT 11092010 © 2010 General Electric Company. All rights reserved.
DRAFT COPY Appendix A:REVIEW Login Administration Figure A-6 Applications Screen 6. Make your desired selections. x The 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.
DRAFT COPY Appendix A:REVIEW Login Administration – 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]. x To make a configuration change, make the necessary changes on the fields, and press the Apply Configuration button.
DRAFT COPY Appendix A:REVIEW Login Administration 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.
DRAFT COPY Appendix A:REVIEW Login Administration x Apply Configuration - Use the Apply Configuration button to save changes. x Restore 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.
DRAFT COPY Appendix A:REVIEW Login Administration 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].
DRAFT COPY Appendix A:REVIEW Login Administration 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 modifications to that user.
DRAFT COPY Appendix A:REVIEW Login Administration Change a User Full Name 1. Select User. 2. Press [Change Name]. 3. Make changes to the name. 4. Press [Confirm Change]. x If you do not want to make the change, simply press the Cancel button. Figure A-10 Change Name Optima XR220amx X-Ray System Operator Manual 54400222-1EN Rev 1 DRAFT 11092010 © 2010 General Electric Company. All rights reserved.
DRAFT COPY Appendix A:REVIEW Login Administration Remove a User 1. Select User. 2. Press [Remove User]. 3. Press [Confirm Removal]. x If you do not want to make the change, simply press the Cancel button. Figure A-11 Confirm Removal Optima XR220amx X-Ray System Operator Manual 54400222-1EN Rev 1 DRAFT 11092010 © 2010 General Electric Company. All rights reserved.
DRAFT COPY Appendix A:REVIEW Login Administration 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]. x This 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.
DRAFT COPY Appendix A:REVIEW Login Administration 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.
DRAFT COPY Appendix A:REVIEW Login Administration – 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. Optima XR220amx X-Ray System Operator Manual 54400222-1EN Rev 1 DRAFT 11092010 © 2010 General Electric Company. All rights reserved.
DRAFT COPY Appendix A:REVIEW Login Administration 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 Optima XR220amx X-Ray System Operator Manual 54400222-1EN Rev 1 DRAFT 11092010 © 2010 General Electric Company. All rights reserved.
DRAFT COPY Appendix A:REVIEW Login Administration Add a Local Group 1. Press [Add Local Group]. x When this button is pressed a popup panel is displayed. 2. Enter the new group's name (which must be unique). x If any errors are encountered, you will receive an error message box. If you receive the error message box, changes were not saved to the database, and you can correct your errors and try again.
DRAFT COPY Appendix A:REVIEW Login Administration 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. x You cannot manage the group memberships for Enterprise groups. This is managed by the directory server, not EA3. Therefore, whenever an Enterprise group is in context, both the 'Add Membership' and 'Remove Membership' buttons will be blocked out.
DRAFT COPY Appendix A:REVIEW Login Administration 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.
DRAFT COPY Appendix A:REVIEW Login Administration 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.
DRAFT COPY Appendix A:REVIEW Login Administration server cannot be reached. Note that hashed passwords are cached, the actual password is not cached. x Enterprise Authentication Latency (Seconds) - The amount of time (in seconds) that the EA3 login process 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.
DRAFT COPY Appendix A:REVIEW Login Administration x Possible problems are wrong IP/server name or the system does not have DNS running / cannot resolve the IP address / server name. x Once 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.
DRAFT COPY Appendix A:REVIEW Login Administration most other directory servers use (i.e. loginAttribute=,). If you are connecting to a non-MSAD directory server, it's pretty safe to say that you should use dn. x DN - 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.
DRAFT COPY Appendix A:REVIEW Login Administration Figure A-19 Highlighted Changes Optima XR220amx X-Ray System Operator Manual 54400222-1EN Rev 1 DRAFT 11092010 © 2010 General Electric Company. All rights reserved.
DRAFT REVIEW COPY Appendix B: Specifications Appendix B: Specifications Power x Capable of 100-240V nominal, 50 /60 Hz operation x System battery status display System Battery x Independent component power management and system battery charging algorithms to maximize usage time x System Battery charge can take 90 typical exams on a single charge x Maximum charge time of 4 hours to go from 10-100% X-ray Tube X-ray Source x Heat Storage Capacity – Anode: TBD Joules (TBD heat units) – Tube Unit: T
DRAFT REVIEW COPY Appendix B: Specifications Tube Positioning x The column may be rotated up to ± 270° from the park position x Tube Angle display and SID measuring tool x Maximum focal spot 200cm (78.7 in): Height x Minimum focal spot 62.5cm (24.6 in): Height x Vertical travel 137.6 cm (54.7 in) x Minimum horizontal extension center of column rotation to centerline of tube: 70.6 cm (27.8 in) x Maximum horizontal extension center of column rotation to centerline of tube: 111.
DRAFT REVIEW COPY Appendix B: Specifications Digital Detector Physical Characteristics x Single panel (non-tiled) amorphous silicon detector with a Cesium Iodide scintillator x Detector battery can take up to 45 exposures per hour and provide enough power for 3 hours of use on a single charge x Detector can support up to 150Kg (330 lbs) of distributed load for bariatric applications x Includes 6:1 removable grid x Includes QAP (Quality Assurance Procedure) x Dimensions: – Length: 23.
DRAFT REVIEW COPY Appendix B: Specifications User Interface x Integrated 15 in (38.
DRAFT REVIEW COPY Appendix B: Specifications Safety and Compliance x RoHS Compliant x Drive Inhibit keypad access for JCAHO compliance x Password protected access to patient information for compliance with confidentiality regulations x Automatic safety brake: Operator must press drive controls to allow system movement x Integrated front bumper stops unit and activates brakes when activated Mechanical Characteristics x Overall Width 55.
DRAFT REVIEW COPY Appendix B: Specifications Environmental Conditions System 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.
DRAFT REVIEW COPY Appendix B: Specifications Options x 802.11 a/b/h/n - Wireless connectivity to hospital network – 802.11 a/b/g/n – Wi-Fi Certified – Compatible with: x 802.11i, Wi-Fi Protected Access 2 (WPA2), WPA x 802.
DRAFT Appendix C:REVIEW MessagesCOPY On Display 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.
DRAFT Appendix C:REVIEW MessagesCOPY On Display 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.
DRAFT Status Messages Appendix C:REVIEW MessagesCOPY On Display Description 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.
DRAFT Appendix C:REVIEW MessagesCOPY On Display Status Messages Description 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. Optima XR220amx X-Ray System Operator Manual 54400222-1EN Rev 1 DRAFT 11092010 © 2010 General Electric Company.
