SenoScan System Installation Manual (Single Phase Power) Assue 1, Revision 000 1-1 GENERAL SECTION 1 GENERAL INFORMATION This section contains general information relating to the SenoScan® Full Field Digital Mammography System (hereafter, SenoScan) and this manual. Information in this section and the preinstallation data provided in Section 2 should be reviewed before you begin the actu- al installation of the SenoScan system. 1-2 OVERVIEW OF THIS MANUAL ‘This manual consists of 5 sections: Section 1 - General Information, contains an overview of this manual, a general description of the SenoScan system, system spec- ifications, symbols used on the system, general information about safety, environmental considerations, and compliance with regulato- ry requirements. Section 2 — Preinstallation, provides a preinstallation checklist, general site considerations, room requirements, and general infor- mation about dimensions, weight, and passage requirements of sys- tem components, Section 3 - Installation, provides detailed information on how to complete the physical installation of the SenoScan system assem- blies into their operating locations. It includes interconnect cabling and primary power hookup information, Section 4~ Post Installation Checks and Alignment Verification, describes how to check system operation and verify the accuracy of critical alignments necessary to assure a fully functioning mammog- raphy system that meets all performance specifications. This section includes installation and calibration instructions for the image detec- tor. Section 5 ~ Acceptance Testing and Installation Reports, pro- vides descriptions of how to perform required acceptance testing and information on filing the required reports. This section contains an Acceptance Test Checklist and a Network Data Sheet. General Information heIssue 1, Revision 000 13 14 SenoScan System Installation Manual (Single Phase Power) RELATED DOCUMENTATION The following documents supplement the contents of this manual by providing operating instructions and service information for SenoS- can, Operator Manual for SenoScan Full Field Digital Mammogra- phy System (part number P-55959-OM) Service Manual for SenoScan Full Field Digital Mammography, System (part number P-55961-SM) DESCRIPTION OF THE SENOSCAN SYSTEM. 14-1 Generator The SenoScan is a complete digital mammography system designed to perform routine and diagnostic examinations of breast tissue. For detailed information on how to operate the SenoScan, refer to the SenoScan System Operator Manual, part number P-55959-OM. In its most basic configuration, the SenoScan is a complete digital mammography imaging system consisting of an x-ray generator, gantry, an acquisition station with a technologist shield, and a re- view station In more complex configurations, the SenoScan system can be ex- panded to include multiple generators, gantrys, and acquistion sta- tions and or multiple review stations, allowing very high volume pa- tient exams and or readings of patient exam images. ‘The SenoScan features a high-performance charge-coupled device (CCD) based digital image acquisition system. Due to the high scn- sitivity, low noise, and wide dynamic range characteristics of digital imaging, the SenoScan acquires high quality x-ray images of the breast at substantially reduced patient exposure. ‘One generator is required for each gantry in the system. ‘The 12 KW high-frequency generator is a self contained assembly that is paired with the SenoScan gantry. The generator produces the high voltage/current required for operation of the x-ray tube and all other voltages required by the system electronics and motion-related functionality contained in the gantry. The generator is microproces- sor-controlled with self-diagnostics which prevent exposures if an General InformationSenoScan System Installation Manual (Single Phase Power) Issue 1, Revision 000 1-4-2 — Gantry operator or system error is detected. Technique factors are variable over a range of 20t0 45 KVp and 80 to 200mA. The generator may be located up to 40 feet away from the gantry. - ‘The SenoScan system can support multiple gantrys. Each gantry must be connected to its own dedicated SenoScan generator. ‘The gantry consists of a vertical column that holds a C-arm. The column can be raised and lowered to accommodate patients of vari- ‘ous statures, and the C-arm can be rotated to acquire different image projections. The C-arm contains the diagnostic source (x-ray tube, collimator, filter), CCD (charged coupled devices) image detector, breast support, and compression assembly. Inside the C-arm housing, the x-ray source and detector are aligned to each other from opposite ends of an internal C-shaped swing arm assembly. This puts the x-ray source and detector on opposite sides of the breast supporv/compression assembly which is located in the ‘open part of the C-shaped swing arm. During image acquisition, the internal swing arm is motor driven to pivot at the x-ray source, caus- ing the detector (at the other end of the swing arm and on the far side of the breast support) to swing in an arc under the breast support from one edge of the breast support to the other. The x-ray, which is shaped into a flat fan-shaped beam by the collimator, passes through the compressed breast tissue as it sweeps across the breast support and falls on the image detector undemeath. The detector and its associated electronics convert the acquired x-ray into a digi- tal data signal which is sent to the acquisition station computer for processing into the actual image. ‘The collimator/filter is automatically reconfigured to provide the proper aperture size when the normal or high-resolution mode is se- lected. The scanned field size is 29 x 21 cm in normal mode and 15 x 11 cm in high-resolution (mag) mode. ‘The digital detector incorporates 4 CCD’s (charge-coupled device), which collectively have a sensitive clement of 405 pixels x 2048 pix- els, with each pixel being 27 micron per side. Overall detector arca is 1m x 22cm. In normal mode, four pixels are combined to in- crease the effective pixel dimension to 54 micron per side. Normal resolution images are 4096 x 5624 pixels or 46 MB in size, High-resolution images consist of the same number of pixels ( 4096 x 5624) and are the same size (46 MB) as in normal mode, but the pixel size is smaller (27 micron per side). General Information 13Issue 1, Revision 000 SenoScan System Installation Manual (Single Phase Power) n/ Technologist Shield ‘One acquisition station is required for each gantry in the system, ‘The acquisition station is the command center from which the tech- nologist images the patient. The acquisition station allows full op- erator control of image acquisition via an on-screen control panel which supports preset patient processing and provides immediate image preview capability as each image is acquired. Acquired im- ages along with relevant patient data are saved to the mirrored hard drives or RAID array which are a part of the SenoScan review sta~ tion. ‘The acquisition station consists of a workstation computer, UPS, flat-panel color monitor, keyboard, mouse, and the x-ray switch. All acquisition station equipment is incorporated into the technolo- gist shield which provides radiation protection for the operator. The technologist shield can be located up to 10 feet (interconnect cable run length) from the gantry. 1-4-4 Review Station ‘The review station provides a capability for fast, high-resolution, on-screen display of the digitally captured images. Images are re- trieved from the SenoScan database for review and/or comparative analysis by the radiologist or physician, Two high-resolution mon- itors are provided to support side-by-side visualization of different projections or comparative analysis of current and previous exams In basic SenoScan configurations (consisting of one acquisition sta- tion and one review station, the review station is connected to the ac~ quisition station via an Ethernet link, and can be physically located anywhere on the Ethernet network. It is typically located in a sepa- rate room from the gantry/acquisition station. In this configuration, the review station computer typically also serves as the Seno Host server. The Seno Host server acts as the local image repository, sys- tem database server, and local archive interface. In more complex configurations (consisting of multiple acquisition stations and more than one review station, one of the reviews station ‘computers may also serve as the Seno Host server to manage data traffic between the different review station computers, the acquisi- tion station computers, and the image storage device(s). General informationSenoScan System Installation Manual (Single Phase Power) Issue 1, Revision 000 Depending up the system configuration, images are stored on mir- rored hard drives in the review station computer, a RAID array con- nected to the Host Seno server, or on a network storage node. If de- sired, images may be archived to the optional magneto-optical drive or the facility’s PACS network. ‘The system supports an optional DICOM-compliant laser printer. 1-5 | SYSTEM CONFIGURATIONS SenoScan can be supplied in the following configurations, 1-5-1 SenoScan System with Multiple Acquisition Stations ‘This configuration provides for multiple cxamination suites (acqui- sition stations) allowing simultaneous acquisition of patient exami- nations. Each suite includes a generator, ganty, and technologist shield. This configuration can be supplied for use with single or multiple review stations. 1-5-2 SenoScan System with Multiple Review Stations ‘This configuration provides for multiple reading room suites allow- ing simultaneous reading of different patient examinations. ‘Typi- cally, in multiple review station configurations, one of the review station computers also serves as the Seno Host server. In some very specific cases, a standalone Seno Host server may be required. Typ- ically, this configuration is supplied for use with very high patient volumes, i.e., systems containing multiple acquisition stations. 16 SYSTEM ACCESSORIES Descriptions for SenoScan system accessories are provided below. 1-6-1 Paddle Accessories General information Compression Paddle ~ 24 x 30cm Compression Paddle — High Resolution ‘Compression Paddle — Spot Compression Paddle — Needle Locator, Open Grid (Option) Compression Paddle ~ Needle Locator, Multi-hole (Option) 1s1-6-2 Optional Accessories The following optional accessories are available for use with your SenoScan. Issue 1, Revision 000 SenoScan System installation Manual (Single Phase Power) 1-6-2-1 Image Storage Devices 1-6-2-1-1 Mirrored Hard Drives (Standard Configuration) ‘This is the standard cofiguration used with basic systems that do not require large image storage capability. Generally, these systems contain a single review station and are networked to PACS, so im- ages can be archived on a regular basis. This configuration does not include a RAID,and relies only on the mirrored hard drives located in the review station computer to provide storage for the patient im- ages. Because of the limited size of the drives, archiving of patient images must be accomplished on a regular basis to ensure that ade- quate storage will always be available for new acquisitions. 1-6-2-1-2 RAID (Random Array of Independent Disks) Storage System ‘This option can be used with systems containing with a single re- view station computer or with systems containing multiple review stations and a Seno Host server. With this option, all patient images are stored on the RAID and will remain there until they are archived toa PACS or an alternative archive device/media. 1-6-2-1-3 Network Storage Node. This option makes use of an optical storage library device (jukebox) that provides virtually unlimited capacity for image storage. The de- vice is DICOM-compatible and assumes the role of a service class provider (SCP). 1-6-2-2 Archive Devices ‘Magneto-Optical Drive, External 1-6-2-3 Laser-Film Printers Kodak 8610 Kodak 8900 Agfa DryStar 4500 FujiFilm FM-DP L 16 General InformationSenoScan System Installation Manual (Single Phase Power) Issue 1, Revision 000 1-7 SYSTEM SPECIFICATIONS 1-7-1 Diagnostic Source Radiation Shielding Radiation shielding is rated for up to 45 kV. Ray Proofing Leakage is less than 80 mR/hr at one meter from the focal spot of the x-ray tube, measured at 45 kV and 150 mA. 1-7-2. X-ray Tube ‘The RAD73 rotating anode x-ray tube incorporates a 49 KV tungsten alloy rotating anode insert that produces a 0.3 mm focal spot. Nominal Focal Spot Size 0.3 mm - maximum focal spot size is 0.45 x 0.65 mm. Maximum Anode Load: 3-Phase 60 Hz ‘ 8.0 KW, 180 Hz, 6.0 sec Inherent Filtration 0.76 mm beryllium IEC 60522 ‘Heat Storage Capacity 1.4 MHU Continuous Heat Dissipation 185 watts (250 HU/sec) Rotating Anode Information disk diameter and construction 102 mm, tungsten alloy anode disk rotational s 29000 RPM (running/boost) General Information 1Issue 1, Revision 000 1-7-4 Filter SenoSean System Installation Manual (Single Phase Power) anode brake profile full speed to full stop in ~10 seconds target angle 16° Filament Current Rating 2.0A standby, 4.44 instantaneous 6-9V @4-524 Full-wave rectification information is provided for the 60 Hz, single phase tubes in the Varian Eimac packet included with this unit. For detailed information on tube emissions and ratings, refer to this packet. Operation Fixed at front and sides, motorized rear blade Projected X-ray Beam 1.cm x 22.5 cm (normal) Lem x 11.5 cm (High-Res) SID (source-to-imager distance) 64.18 cm fixed Additional Equivalent Filtration in X-ray Beam 0.5 mm (aluminum) for normal operation 2.0 mm (aluminum) for calibration — automatically selected 18 General InformationSenoScan System Installation Manual (Single Phase Power) Issue 1, Revision 000 1-7-5 Generator Output 12 KW, max Duty Cycle ‘The duty cycle is limited by the capacity of the x-ray tube. Refer to the Tube Specifications subsection for manufacturer's infor- ‘mation concerning the tube capacity, BrUMr 2500 ‘The BTU/AR rating is based on a system using the average num- ber of patients examined during a specified amount of time. Average examine times and procedures were used in determin- ing the technique factors and system use for a typical day and power used. This rating has been determined using the heat pro- duced from a stand-by condition, Output kV Specification 20 To 45 Kv in 1 KV increments Deviation From Indicated £(3 KV +1KV) of the indicated kV Output mA ‘Specification 10 to 220 mA in 10 mA increments Allowable 80 t0 220 mA, Deviation + (5% +5 mA) of the indicated mA General Information 19Exposure (mAs) Time ‘The mAs waveform begins upon reaching 10% after the start of the waveform, and ends upon reaching a trailing edge of 75%. 1-7-6 Maximum Radiography Ratings 200 mA, S0KVp 10kW 1-8 LINE REQUIREMENTS 1-8-1 Generator ‘The SenoScan gantry is powered by the generator. Acquisition Sta- Issue 1, Revision 000 SenoScan System Installation Manual (Single Phase Power) tion and Review station components are independently powered from facility line power. 1-8-1-1 Line Conditions Single phase, 50/60 Hz +1 Hz 2 line (Hot and Neutral/Ground with independent Earth Ground) ‘To ensure correct system operation, the Ground and Neutral 4 lines must be tied together at the input transformer or in the Main Service Entrance Panel following the input transformer. Note: ‘The line requirements listed in the following paragraphs are for a one set of examination room equipment consisting of one SenoSean generator, gantry, and acquisition station. For multiple examinination rooms, multiply the line requirements accordingly. 1-8-1-2 _- Nominal Line Voltages 240 Vac + 10%, single phase 1-8. 3 Line Regulation at Max Load 10% (0.1 9 max impedance) 110 General InformationSenoScan System Installation Manual (Single Phase Power) Issue 1, Revision 000 1-8-1-4 Recommended Circuit Breaker 70.0A 1-8-1-5 Continuous and Peak Current 4 amp continuous/70 amp peak Note: Peak current is experienced during x-ray exposure for a maximum duration of 8 seconds. 1-8-1-6 Transient Line Voltage Variation ‘The maximum variation due to causes other than the x-ray equip- ment load should not exceed + 2.5% from nominal current voltage; the waveform must be sinusoidally balanced to ground with less than 2% harmonic distortion. 1-8-1-7 Recommended Minimum Rating for Supply Transformer 16 kVA 1-82 Review Station * UPS: 12A (max) @ 120 Vac, 50/60 Hz, 980W, 1400 VA. Note: The UPS powers the review workstation computer, RAID, and MO Drive. * High-Resolution Monitor: 2.3 (max) @ 120 Vac, 50/60 Hz (each, 4.6A for 2 monitors) + Workstation Monitor: 2.0A (max) @ 120 Vac, 50/60 Hz *+ Laser-Film Printer (optional): 6.3/3.2A (max) @ 100/240 Vac, 50/60 Hz General Information LrIssue 1, Revision 000 SenoScan System Installation Manual (Single Phase Power) 19 1-10 ENVIRONMENT SYMBOLS ‘Temperature Operating 50 to 80° F (10 to 26.6° C) Storage/Shipping 14 to 122° F (-10 to 50° C) Relative Humidity 10 to 80% (non-condensing) ‘The following symbols are affixed to the interior and exterior of the ‘SenoScan system to alert installation and service personnel to poten- tial hazards and operational functions: As AN AN R © Dangerous Voltage Dangerous voltages are present. (This symbol may also appear without the triangle border.) Warning This equipment is not suitable for use in the presence of a flammable anesthetic mixture with air or oxygen or nitrous oxide. Attention: A potential hazard to operator, service personnel, or equipment exists. Refer to the technical manual for instructions before proceeding. Danger X-Rays This equipment produces ionizing radiation when energized. Protective Earth (ground) General InformationSenoScan System Installation Manual (Single Phase Power) Issue 1, Revision 000 Earth (ground) Type B Applied Part ‘This equipment meets the requirements of EN60601-1 for protection against electric shock. Power Off Disconnection from the mains. Used on power switches. Power On Connection to the mains. Used on power switches. lonizing Radiation aa This symbol (yellow) is used as the x-ray indicator a on both sides of the gantry column. X-ray emission is taking place when this symbol is displayed. I Standby C4) tris symbor (green) is paired with the ionizing radi- ation symbol on the sides of the gantry column, The system is energized when this symbol is displayed. Mode of Operation ‘SenoScan is designed for continuous operation with short time loading. Short time loading is defined as: one 10 second (max) x-tay exposure every 2.5 minutes or 4 x-ray exposures in 10 minutes. < No Symbol> General Information 13Issue 1, Revision 000 SenoScan System Installation Manual (Single Phase Power} 1-1 Lid SAFETY Everyone associated with x-ray work must be familiar with the rec- ‘ommendations of the Center for Devices and Radiological Health (CDRH), National Bureau of Standards, the National Council on Radiation Protection (NCRP), and the International Committee on. Radiation Protection (ICRP). The contro! of diagnostic medical x-ray equipment changes slightly from state to state. In general, all states adhere to the established recommendations of the NCRP. Be sure that all personne] authorized to operate the x-ray system are familiar with the established regulations of the authorities named above. You might wish to monitor all personnel to ensure compli- ance with recommended procedures. Current source of information includes: + National Council _on Radiation Protection_and_Measurements (NCRP) Report No, 49 (“Structural Shielding Design and Evaluation for Medical Use of X Ray and Gamma Ray Energies up to 10 MEV ~ 1976") + National Council_on Radiation Protection and Measurements (NCRP) Report No. 102 ("Medical X-ray, Electron Beam, and Gamma Ray Protection for Energies up to 50 MEV — Equipment Design, Performance, and Use ~ 1989") + National Bureau of Standards Handbook No. 76 ("Medical x-ray Protection up to Three Million Volts"); Refer to NCRP Report No. 102. + Current recommendations of the Intemational Committee on Radiation Protection. Although x-radiation is hazardous, x-ray equipment does not pose any danger when properly used. Be certain all service and operating personnel are properly educated concerning the hazards of radiation. Persons responsible for the system must understand the safety re- quirements and special warnings for x-ray operation. Review this ‘manual to become aware of all safety and operation requirements. General InformationSenoScan System Installation Manual (Single Phase Power) Issue 1, Revision 000 1-1-1 Maximum Permissible Dose (MPD) Various studies on the effects of x-radiation have provided a foun- dation for establishing the maximum permissible dose of x-radiation to which an individual may be exposed. The results of these studies have been used by the NCRP and the ICRP to develop recommen- dations for MPD. ICRP recommends that the MPD to the most critical organs (heart, lungs, liver, kidney, and brain) accumulated at any age shalll not ex- ceed five rems multiplied by the number of years beyond 18: MPD =5 x (n-18)rems where n= age in years In no case shall the exposure exceed three rems in any period of 13 consecutive weeks. For hands, forearms, feet, and ankles, the recommended MPD is 75 rems in any one year. 1-11-2 Manufacturer’s Responsibility Although this equipment incorporates protection against x-radiation other than the useful beam, practical design does not provide com- plete protection. Equipment design docs not compel the operator or assistants to take the necessary precautions; nor does it prevent the possibility of improper use (authorized or unauthorized persons carclessly, unwisely, or unknowingly exposing theinselves or others to direct or secondary radiation). Allow only authorized, properly trained personnel to operate this equipment. Be certain that all individuals authorized to use the equipment are aware of the danger of excessive exposure to x-radiation. ‘This equipment is sold with the understanding that Fischer Imaging, its agents and representatives, do not accept any responsibility for overexposure of patients or personnel to x-radiation, Furthermore, Fischer Imaging does not accept any responsibility for overexposure of patients or personnel to x-radiation generated by this equipment as a result of poor operating techniques or proce- dures. General Information rasIssue 1, Revision 000 SenoScun System Installation Manual (Single Phase Power) Also, no responsibility is assumed for any unit that has not been ser- viced and maintained in accordance with the technical service man- ual, or which has been modified or tampered with in any way. 11-3 Radiation Protection Because exposure to x-radiation may be damaging to health, use ‘great care to provide protection against exposure to the primary beam. Some effects of x-radiation are cumulative, and may extend over a period of months or years. The best safety rule for x-ray op- crators is to 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 de- pendent upon the energy and intensity of the primary beam, and on the atomic number of the object or material struck by the primary beam. Secondary radiation may be of greater intensity than that of the radiation reaching the detector receptor. Take protective mea- sures to safeguard against secondary radiation, An effective protective measure is the use of lead shielding. To min- imize dangerous exposure, use movable lead screens, lead-improg- nated gloves, and lead-impregnated aprons, These protective devie- es must contain a 0.25 millimeter thickness of lead or the equivalent. Use such protective devices for all operators, observers, and/or ser- vicing personnel exposed to radiation fields of 5 or more milli Roentgens per hour. 1-11-4 Monitoring Personnel Monitoring personnel to determine the amount of radiation to which they have been exposed provides a valuable crosscheck to determine whether or not safety measures are adequate. This crosscheck may reveal inadequate or improper radiation protection practices and/or serious radiation exposure situations. ‘The most effective method of determining whether the existing pro- tective measures are adequate is the use of instruments to measure the exposure (in rads). This measurement should be taken at all 1o- cations where the operator, or any portion of the operator's body, may be inadequately shielded during exposure. Exposure must nev- er exceed the accepted tolerable dose. A common method of determining whether personnel have been ex- posed to excessive radiation is the use of film badges. These are X-ray sensitive film enclosed in a badge which incorporates metal General InformationSenoScan System Installation Manual (Single Phase Power) Issue 1, Revision 000 filters of varying degrees of transparency to x-ray radiation. Even though this device only measures the radiation reaching the area of the body on which it is worn, it does furnish an indication of the amount of radiation received. 1-12 CDRH COMPLIANCE ‘The SenoScan complies with Department of Health and Human Ser- vices radiation performance standards per 21 CER, Chapter I, Sub- chapter J. 1-121 Certified Components General Information ‘The following components are certified for use with SenoScan Full Field Mammography System 105200G. Certification is applicable when components are installed, calibrated, and serviced in accor- dance with all applicable instructions. Unauthorized modifications will invalidate certification. * SenoScan Inverter CPU 89864G-1 + Xeray Tube 94518-3 * Collimator/Filter Assembly 94710M-3 + Detector 94767-1 + HF/HY Transformer Assembly 94292G + SenoScan Inverter 105291G + SenoScan Breast Support 94761-Issue 1, Revision 000 SenoScan System Installation Manual (Single Phase Power) 1-14 1-122 Compatible Components ‘The following components are compatible with the above system Kodak 8610 Laser Imaging System 94852-1 Agfa Dry Star 4500 104339 FujiFilm FM-DP 1 104340 1-13 CORRECT EQUIPMENT INSTALLATION Correct equipment installation begins with adequate structural shielding. The ceiling, floor, doors, windows, and interior partitions of the radiological area must be evaluated and designed to include necessary attenuating barrier materials. You must install the opera- tor’s acquisition station enclosure, containing a Jead-glass technolo- gist shield, within the radiological area. A current source of infor- mation on this subject is the National Council of Radiation Protec- tion and Measurements (NCRP) Report No. 49 "Stuctural Shielding Design and Evaluation of Medical Use of X-rays and Gamma Rays of Energies Up To 10 MEV,” 7910 Woodmont Avenue, Suite 800, Bethesda, MD 20814-3095. In addition to these considerations, radiological installations must comply with all applicable local, municipal, and state electrical codes and laws. PROTECTING THE ENVIRONMENT 1-14-1 Disposal of Transformer Oil ‘The dielectric oil used in the high voltage transformer in the SenoS- can Generator can pose a risk of environmental contamination if itis not disposed of properly. is act all applicable na- doe: for ion. A copy of the Material Safety Data Sheet for the dielectric oil is available upon request. General InformationSenoScan System Installation Manual (Single Phase Power) Issue 1, Revision 000 1-14-2 Disposal of UPS Batteries The batteries in the two uninterruptable power supplics (UPS) as- semblies used with the ScnoScan system can pose a risk of environ ‘mental contamination if they are not disposed of properly at the end of their service life, ‘You must dispose or recvcle UPS batteries in accordance with i wvincial, tis loca- tion. 114-3 Disposal of Lithium Batteries ‘The 89864G-1 Digital Mammo CPU, the 94244-1 Embedded Con- troller VME circuit board assemblies, and the two computers used in the acquisition and review stations contain lithium batteries which can pose a risk of environmental contamination if they are not dis- Posed of properly at the end of their service life. ‘ou must dij ithi fries in a ce ith all nat ial, and local regulations for your location, 1-144 Return of X-ray Tubes ‘The x-ray tube used in the SenoScan contains a beryllium window and lead shielding, and can pose a risk of environmental contamina- tion if itis not disposed of properly at the end of its service life. fective x-ray tu st not be dis L. They are to be re- tumed to Fischer Imaging Corporation for processing. After re- Placement, pack the defective tube in the packaging that was used for shipment of the replacement tube, then contact Fischer Imaging at 800-825-8434. You will be given a Return Materials Authoriza- tion (RMA) number and specific instructions on how to return the tube. General Information Ly