Lunar Prodigy

PRODIGY

Service Manual Part Number: LUN7396 Revision: C

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Prodigy Service Manual

This document contains confidential or proprietary information of GE-Lunar Corp. neither the document nor the information is to be reproduced, distributed, used or disclosed, either in whole or in part, except as specifically authorized by GE-Lunar Corp. GE-LUNAR Corporation makes no warranty of any kind with regard to this material, and shall not be held liable for errors contained herein or for incidental or consequential damages in connection with the furnishings or use of this manual. Read through this manual thoroughly before attempting to service any components. Unauthorized service may void system warranties or service contracts. Consult the GE-LUNAR Customer Support Department prior to attempting any servicing: 608-828--2663 608-826-7107 (Fax)

g

is a registered trademark of General Electric Company.

PRODIGY® is a trademark of GE-LUNAR Corporation. Windows NT® is a trademark of Microsoft Corporation

Copyright© 2000 by GE-LUNAR Corporation. Madison, Wisconsin. All rights reserved.

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READ THIS FIRST Using This Manual: A person who will be performing service work on the PRODIGY should use this manual in the following manner: Read the Safety and Overview Chapters to familiarize yourself with the scanner as a whole and with the general function of the circuit boards. Chapter 3 should be understood completely as it explains the Diagnostics Software (built in – requires a password for access). The Chapter 4 and Chapter 5 contain common procedures and troubleshooting information and can be read as needed, but are good sources of information. When a problem arises, Chapter 4 should be referenced. Check the table of contents for Chapter 4 to see if the problem being experienced is described. If so, refer to the appropriate page. If not, try to generalize the problem (e.g. the Detector is repeatedly running into the front of the scanner and reversing and then running back into the front of the scanner. This is a mechanical problem in general, specifically with Transverse Mechanics, check that subsection of Chapter 4 for the subsystem experiencing the fault. This manual commonly references other Sections and pages of the manual as needed, so often procedures in the Chapter 5 Appendix are referred to as ways to solve problems described in Chapter 4.

Information Requested By GE-LUNAR: When requesting assistance from GE-LUNAR, please provide the following information: System Number (DF+xxxxx) Institution or Doctor's name Location Complete list of symptoms Names and part numbers of parts needed for service

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In addition to the information above, an Error Log printout and QA’s and QA history or other failing diagnostic test printout (Alignment Test etc.) will also help to improve the accuracy of our diagnosis: For problems with specific patient scans, it is recommended that you copy the scan files to diskette, and send it, with a description of the problem, to the Applications Department at GE LUNAR.

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1 1 2 Safety Chapter 1:Safety

This chapter highlights safety devices and features a Service Engineer should know before servicing a PRODIGY system. Chapter Contents: 1.0 General Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-15 1.1 Symbols and labels found on the PRODIGY . . . . . . . . . . . . . . . . . . 1-15 1.1.1 External Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-15 1.1.2 Internal Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-16 1.1.3 Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-16 1.2 Emergency Stop Button . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-19 1.3 Laser Exposure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-20 1.4 Shutter Indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-21 1.5 Cautions, Warnings, and Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-21 1.5.1 Caution Statements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-21 1.5.2 Warning Statements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-22 1.5.3 Note Statements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-22 1.6 Safety Concerns . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-22 1.6.1 Pinch points . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-22 1.6.2 Laser safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-23 1.6.3 Radiation safety. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-24 1.6.4 Scatter Radiation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-24 1.7 Controlling Computer and Accessories . . . . . . . . . . . . . . . . . . . . . . 1-26 1.7.1 Electrical Safety. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-26 1.7.3 Peripheral Configurations . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-26 1.7.4 Standard room configuration (system no. DF+12000 and greater)126 1.7.5 Small room configuration (system no. DF+12000 and higher) 1-27 1.7.6 Scanner power output configuration (system no. DF+11999 and lower) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-27 1.7.7 Wall outlet configuration (system no. DF+11999 and lower) . . 1-27 Figure 1-1. The PRODIGY Display Panel . . . . . . . . . . . . . . . . . . . . . . . 1-19 Figure 1-2. Laser Warning Label (U.S. systems only) . . . . . . . . . . . . . . 1-20 Figure 1-4. Laser Warning Label (International systems only) . . . . . . . . 1-20 Figure 1-5. Source (x-rays) off - Shutter closed (green) . . . . . . . . . . . . . 1-21

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Figure 1-6. Source (x-rays) on - Shutter open (yellow). . . . . . . . . . . . . . 1-21 Figure 1-7. Potential Pinch Points on the PRODIGY . . . . . . . . . . . . . . . 1-23 Figure 1-8. PRODIGY Iso-Dose Diagram . . . . . . . . . . . . . . . . . . . . . . . . 1-25

This document contains confidential or proprietary information of GE-Lunar Corp. Neither the document nor the information therein is to be reproduced, distributed, used or disclosed, either in whole or in part, except as specifically authorized by GE-Lunar Corp.

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1.0

General Safety • DO NOT attempt to service the PRODIGY without first reading this manual. • DO NOT attempt any repairs without prior instructions from authorized LUNAR personnel. • In order to maintain electrical safety and electromagnetic compatibility, the Lunar PRODIGY is only to be connected to a computer, printer, and peripherals that are certified to be compliant with IEC 950/EN 60950 Safety of information technology equipment, including electrical business equipment and IEC 601-1-2 Medical electrical equipment, Part 1: General requirements for safety, 2. Collateral Standard: Electromagnetic compatibility - Requirements and tests.Emergency Stop Button

1.1

Symbols and labels found on the PRODIGY 1.1.1 External Symbols • The following symbols are found on the PRODIGY, in the Operators manual, and in the Service Manual.

Attention: contains important safety information such as the location of a pinch point.

Emergency Stop Button: shows the location of the emergency stop button.

Power On: shows the location of the Power On indicator and the switch position for Power On.

Power Off: shows the switch position for Power Off.

Laser On: shows the location of the Laser On indicator. It is found only on systems delivered internationally.

This document contains confidential or proprietary information of GE-Lunar Corp. Neither the document nor the information therein is to be reproduced, distributed, used or disclosed, either in whole or in part, except as specifically authorized by GE-Lunar Corp.

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Shutter Open: shows the location of the Shutter Open indicator.

X-ray On: shows the location of the X-Ray On indicator.

Type B Equipment: shows that the scanner has Type B protection against electrical shock.

1.1.2 Internal Symbols • The following symbols are found inside the PRODIGY, and in the Service Manual.

Protective Earth: shows the location of a Protective Earth Terminal.

Functional Earth: shows the location of a Functional Earth Terminal.

1.1.3 Labels • The following labels are found on the PRODIGY Scanner.

Laser Caution Label: Shows that the scanner uses a Class II laser. This label is not found on systems shipped to Canada.

Laser Caution Label: Canada only

This document contains confidential or proprietary information of GE-Lunar Corp. Neither the document nor the information therein is to be reproduced, distributed, used or disclosed, either in whole or in part, except as specifically authorized by GE-Lunar Corp.

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Tube Head Assembly Label (system number DF+12000 and greater): This label gives tube head assembly and x-ray source characteristics information. It is located on the tube head assembly and the foot panel of the scanner.

Tube Head Assembly Label (system number DF+11999 and lower): This label gives tube head assembly and x-ray source characteristics information. It is located on the tube head assembly and the foot panel of the scanner. A definition of each symbol on this label follows: Inherent Filtration

Tube Insert X-ray Source Focal Point

System Label (system number DF+12000 and greater): This label gives system input power requirements and compliance information. It is located on the foot panel of scanners. The CE mark shows compliance with UL/CSA and the Medical Device Directive 93/42/EEC.

System Label (system number DF+11999 and lower): This label gives system input power requirements and compliance information. It is located on the foot panel of scanners. The CE mark shows compliance with UL/CSA and the Medical Device Directive 93/42/EEC.

This document contains confidential or proprietary information of GE-Lunar Corp. Neither the document nor the information therein is to be reproduced, distributed, used or disclosed, either in whole or in part, except as specifically authorized by GE-Lunar Corp.

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High Voltage Power Supply: This label gives high voltage power supply (x-ray generator) information. It is located on the positive and negative power supplies, and foot panel of the scanner.

X-ray Controller: This label shows x-ray controller compliance. It is located on the foot panel of the scanner.

Collimator Assembly: This label gives collimator assembly information. It is located on the collimator and foot panel of the scanner.

Warning Label and Radiation Symbol: The Warning label shows that the system uses ionizing radiation. It is found only on systems delivered in the United States. Always obey instructions for safe operation. Radiation Label: This label shows that the system uses ionizing radiation.

Grounding Reliability Label: This label states that grounding reliability can only be maintained when using a “Hospital Grade” or “Hospital Only” receptacle. It is only found on systems delivered in the United States.

This document contains confidential or proprietary information of GE-Lunar Corp. Neither the document nor the information therein is to be reproduced, distributed, used or disclosed, either in whole or in part, except as specifically authorized by GE-Lunar Corp.

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1.2

Emergency Stop Button • The Emergency Stop Button is a round red button located on the scanner display panel (see Figure 1-1). When pressed, power is removed from the X-ray tube head, the laser, and the shutter is closed. Power is also removed from the scan arm motors, allowing the operator/patient to push the scan arm out of the way.

Figure 1-1. The PRODIGY Display Panel

This document contains confidential or proprietary information of GE-Lunar Corp. Neither the document nor the information therein is to be reproduced, distributed, used or disclosed, either in whole or in part, except as specifically authorized by GE-Lunar Corp.

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1.3

Laser Exposure • The PRODIGY is equipped with a Class II Laser device. This laser is used for patient positioning. A Class II rating indicates a low power visible laser that is not normally hazardous to eyesight but has the potential to be hazardous if viewed directly for an extended period of time. Because of this potential hazard, DO NOT stare directly into the beam while the laser is in operation, and DO NOT allow the beam to shine directly into the patients' eyes. No specific eye protection is required with a Class II laser. • A amber laser-on indicator, located on the front of the scan arm, is lit when the laser is on. The program activates the laser during positioning for an image acquisition. The program then turns off the laser when you begin the scan. The emergency stop button will turn off the laser. • There is a caution label (Figure 1.2) on the scan arm near the Display Panel.

Figure 1-2. Laser Warning Label (U.S. systems only)

Figure 1-3. Laser Warning Label (Canadian Systems only)

Figure 1-4. Laser Warning Label (International systems only) Note:

DO NOT STARE INTO THE BEAM while the laser is operating.

This document contains confidential or proprietary information of GE-Lunar Corp. Neither the document nor the information therein is to be reproduced, distributed, used or disclosed, either in whole or in part, except as specifically authorized by GE-Lunar Corp.

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1.4

Shutter Indicator • This symbol is used to indicate an open-shutter condition in accordance with the safety standards established by the International Electrotechnical Commission (IEC).

Figure 1-5. Source (x-rays) off - Shutter closed (green)

Figure 1-6. Source (x-rays) on - Shutter open (yellow) • This symbol appears near the yellow X-ray shutter-open indicator light. The X-ray shutter-open indicator light is located on the Display Panel on the scan arm near the front. Note:

1.5

When the x-ray on / shutter open symbol appears in literature associated with the PRODIGY scanner, it will be used to indicate that the procedure being described results in an openshutter condition. During these times personnel should exercise caution to avoid excessive exposure to the X-rays.

Cautions, Warnings, and Notes • This manual contains warning and caution statements wherever appropriate for your safety. The warnings and cautions used throughout the manual are based on the safety standards established by the International Electrotechnical Commission (IEC). In addition, the manual uses notes to attract the reader's attention to important information.

1.5.1 Caution Statements A caution statement reflects a condition that, if not avoided, could cause equipment or property damage.

This document contains confidential or proprietary information of GE-Lunar Corp. Neither the document nor the information therein is to be reproduced, distributed, used or disclosed, either in whole or in part, except as specifically authorized by GE-Lunar Corp.

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1.5.2 Warning Statements A warning statement reflects a potentially hazardous condition that, if not avoided, could result in serious injury.

1.5.3 Note Statements Note:

1.6

This symbol turns the reader's attention to important information which may otherwise be overlooked.

Safety Concerns 1.6.1 Pinch points The Warning label below identifies the location of possible pinch points Because the PRODIGY Densitometer contains moving parts, there are places on the scanner where there is a danger of pinching. Operators should be aware of these pinch points to avoid injury to the patient or themselves. When the scanner arm is in motion, make sure possible pinch point locations are clear at all times. Labels applied at the LUNAR factory indicate the location of the pinch points. The pinch points and their labels are shown in the figure 1-7.

This document contains confidential or proprietary information of GE-Lunar Corp. Neither the document nor the information therein is to be reproduced, distributed, used or disclosed, either in whole or in part, except as specifically authorized by GE-Lunar Corp.

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Figure 1-7. Potential Pinch Points on the PRODIGY Do not touch the AC Surge Suppressor (located on the AC terminal block) it may be hot. Do not electrically connect the isolation transformer bolt head to ground, doing this will short out the transformer Scan table isolated outlet strip must be appropriately connected.

1.6.2 Laser safety DO NOT STARE INTO THE LASER BEAM during patient positioning and Quality Assurance procedures. The label that follows is located on the scanner arm and shows the location of the laser aperture.

This document contains confidential or proprietary information of GE-Lunar Corp. Neither the document nor the information therein is to be reproduced, distributed, used or disclosed, either in whole or in part, except as specifically authorized by GE-Lunar Corp.

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1.6.3 Radiation safety X-ray exposure: The system makes radiation when electric voltage is supplied to, and current flows through, the x-ray tube. During a measurement, the shutter opens to let a beam of radiation pass through the scanner table and patient. The radiation field at the table top is 19.2 mm x 3.3 mm. Lead oxide shielding surrounds the x-ray tube insert inside the tube housing assembly and reduces radiation levels around the scanner table. Skin entrance dose: Table 1 of the PRODIGY Operators Safety and Specifications manual shows irradiation times and skin entrance doses.

1.6.4 Scatter Radiation • There is some scatter radiation from the PRODIGY when it is running. Figure 1-8 shows the radiation dosages while the scanner is running at 3.00 mA at certain distances. • These dosages are relatively insignificant as the allowed yearly dosage for a person working with radiation emitting equipment is 5000 mRem. Radiation however should be avoided when possible.

This document contains confidential or proprietary information of GE-Lunar Corp. Neither the document nor the information therein is to be reproduced, distributed, used or disclosed, either in whole or in part, except as specifically authorized by GE-Lunar Corp.

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Figure 1-8. PRODIGY Iso-Dose Diagram

This document contains confidential or proprietary information of GE-Lunar Corp. Neither the document nor the information therein is to be reproduced, distributed, used or disclosed, either in whole or in part, except as specifically authorized by GE-Lunar Corp.

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1.7

Controlling Computer and Accessories 1.7.1 Electrical Safety IEC and UL/CSA certification IEC: To maintain electrical safety, all computer equipment and accessories connected to the scanner must meet all IEC requirements for safety, such as IEC 950, "Safety of information technology equipment, including electrical business equipment," and IEC 801-5, "EMC Surge Immunity Requirements." The computer and all accessories must have the CE label. UL/CSA: To maintain electrical safety, all computer equipment and accessories connected to the scanner must have safety agency approvals for UL/CSA.

1.7.2 Electromagnetic interference Although the scanner meets safety standards regarding electromagnetic interference (EN60601-1-2), you may still experience a loss of performance under extreme electromagnetic conditions. Maximize the distance between the scanner and other equipment, and use a dedicated power line, to avoid interference to and from the scanner.

1.7.3 Peripheral Configurations The correct connection of the computer and all peripherals is necessary to maintain electrical safety. The signal cable of the scanner is intended only for connection to an approved computer. Call LUNAR Support or your LUNAR distributor before adding peripherals. Note:

The scanner's output power strip can be used to supply the Host PC with isolated power. If it is to be used the following conditions must be met. If the conditions cannot be met, the scanner's output power strip cannot be used.

Note:

See also Peripheral Block Diagrams - Section 2.2.3

1.7.4 Standard room configuration (system no. DF+12000 and greater) The computer, peripherals, and all other equipment must be located more than 1.83 m from the scanner. Use an outlet strip to power the computer and all peripherals. The outlet strip must be mounted off the floor so that it does not touch other equipment. If your outlet strip was provided by LUNAR, it has a maximum output of 15A, 120VAC. Only system-related equipment should be powered by the outlet strip. This document contains confidential or proprietary information of GE-Lunar Corp. Neither the document nor the information therein is to be reproduced, distributed, used or disclosed, either in whole or in part, except as specifically authorized by GE-Lunar Corp.

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A modem and/or network connection can be made at any time if you are using the standard room configuration.

1.7.5 Small room configuration (system no. DF+12000 and higher) You must power the computer, peripherals, and all other equipment with an isolating transformer if the room is too small to maintain at least 1.83 m of separation between the scanner and all other equipment. The isolation transformer supplied by LUNAR has a maximum output of 400/ 500VA. Only system-related equipment should be powered by the isolation transformer. Failure to use an isolation transformer can cause leakage currents in excess of 100 microamperes. A modem and/or network connection can only be made in the small room configuration if all exposed metal surfaces of the computer and peripherals are out of the patient environment.

1.7.6 Scanner power output configuration (system no. DF+11999 and lower) LUNAR recommends that you use scanner power output to provide isolated power to the computer and all peripherals. The power strip must be mounted off the floor such that it does not touch other equipment. The computer and ALL peripherals must be powered by the scanner. All other equipment must not be powered by the scanner and must be located more than 1.83 m from the scanner. Failure to use scanner power output can cause leakage currents in excess of 100 microamperes. If a network and/or modem connection is needed, refer to the wall outlet configuration.

1.7.7 Wall outlet configuration (system no. DF+11999 and lower) As an option to scanner power output, a wall outlet can be used to power the computer and peripherals. Isolated power from the scanner must not be used to power any equipment if a wall outlet is used. All exposed metal surfaces of the computer, peripherals, and other equipment must be located more than 1.83 m from the scanner. A network and/or modem connection can be made to the computer if power is supplied from a wall outlet as described above.

This document contains confidential or proprietary information of GE-Lunar Corp. Neither the document nor the information therein is to be reproduced, distributed, used or disclosed, either in whole or in part, except as specifically authorized by GE-Lunar Corp.

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2 1 2 System Overview Chapter 1:System Overview

This chapter provides an overview of the PRODIGY system. • In addition the chapter contains a brief discussion of major subsystems and illustrations of the PRODIGY power system. • This Chapter contains the PRODIGY Block Diagrams 2.0 PRODIGY System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-33 2.0.1 PRODIGY Electronics . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-33 2.1 Electronics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-35 2.1.1 Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-35 2.1.2 Electronics Pan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-35 2.1.3 Scan Arm. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-36 2.1.4 Power specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-36 2.2 PRODIGY Block Diagrams . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-38 2.2.1 PRODIGY I (System numbers DF+11999 and lower) Power Distribution Block Diagram (AC entrance) . . . . . . . . . . . . . . . . . 1-38 2.2.2 PRODIGY System Block Diagram PRODIGY I System Block Diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-39 2.2.3 PRODIGY I Peripheral Configuration Block Diagrams . . . 1-40 2.2.4 PRODIGY II System / Power Block Diagram . . . . . . . . . . 1-41 2.3 PRODIGY Fusing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-42 2.4 PRODIGY I (system numbers DF+11999 and lower) Single Board Controller . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-43 2.4.1 SBC Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-43 2.4.2 SBC Reset. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-43 2.4.3 SBC / Host PC Interface . . . . . . . . . . . . . . . . . . . . . . . . . . 1-44 2.5 PRODIGY II Combined Single Board Controller (cSBC) (systems DF+12000 and greater) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-45 2.5.1 cSBC System Architecture . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-45 2.5.2 cSBC Functions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-46 2.5.3 TRANS / LONG MOTOR Control and Status . . . . . . . . . . . . . 1-50 2.5.4 AGS ROLL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-51 2.5.5 AGS DAC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-51 2.5.6 SCANNER RESET . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-52 2.5.7 GE-LUNAR Model 7861 X-ray Generator Errors. . . . . . . . . . . 1-53 2.5.8 DC FAIL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-54

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2.5.9 DCA / AGS / BIAS DAC's . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-54 2.5.10 KV/mA DAC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-55 2.5.11 ARC/FIL DAC. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-55 2.5.12 PEAK DAC. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-55 2.5.13 MAX PLD Peripherals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-55 2.5.14 Interrupts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-56 2.5.15 MASTER RESET . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-56 2.5.16 SUICIDE RESET . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-57 2.5.17 MISC OUT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-57 2.5.18 MISC IN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-57 2.5.19 Stepper Motor Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-58 2.5.20 OMI Input . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-59 2.5.21 Patient Positioners. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-59 2.5.22 Limit Switches . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-59 2.5.23 X-ray Source Control / Mechanical Interlocks . . . . . . . . . . . . 1-59 2.5.24 Shutter / Collimator Drive. . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-60 2.5.25 End of Exposure Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-60 2.5.26 Panel LED's . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-60 2.5.27 HVPS Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-60 2.5.28 ADC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-61 2.5.29 mA Low Range . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-61 2.5.30 Detector Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-61 2.5.31 Communications Ports. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-62 2.5.32 Debug RS-232 Port . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-62 2.5.33 Diagnostic LED's . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-62 2.6 Power Distribution (PRODIGY II Systems DF+1200 and greater) . . 1-64 2.7 Tube Head and X-ray Insert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-65 2.7.1 X-ray generation and Spectrum. . . . . . . . . . . . . . . . . . . . . 1-65 2.8 X-ray Generator (High Voltage Power Supply(ies)) . . . . . . . . . . . . . 1-66 2.9 MAX Board (PRODIGY I systems DF+11999 and lower only) . . . . . 1-67 2.9.1 MAX Board Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-67 2.9.2 Dedicated +28VDC power supply . . . . . . . . . . . . . . . . . . . 1-67 2.10 XORB Board (PRODIGY I Systems DF+11999 and lower only). . . 1-68 2.11 Detector Sub System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-69 2.11.1 Detector Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-69 2.11.2 Detector Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-69 2.11.3 Detector Daughter Board Overview . . . . . . . . . . . . . . . . . 1-70 2.11.4 Detector Daughter Board Operation . . . . . . . . . . . . . . . . 1-71 2.11.5 Detector Mother Board Overview. . . . . . . . . . . . . . . . . . . 1-72 2.11.6 Detector Mother Board Operation . . . . . . . . . . . . . . . . . . 1-72 2.12 FOINK (PRODIGY I Systems DF+11999 and lower only) . . . . . . . 1-74 2.12.1 FOINK Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-74 2.12.2 Motion Control and Detection . . . . . . . . . . . . . . . . . . . . . 1-74 2.13 Display Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-75 2.14 Audible X-RAY OFF Signal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-77 This document contains confidential or proprietary information of GE-Lunar Corp. Neither the document nor the information therein is to be reproduced, distributed, used or disclosed, either in whole or in part, except as specifically authorized by GE-Lunar Corp.

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PRODIGY Service Manual (Rev C - 2000)

2.15 X-Ray Collimator Subsystem . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-78 2.16 PRODIGY Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-79 2.16.1 Component specifications . . . . . . . . . . . . . . . . . . . . . . . . 1-79 2.16.2 Functional specifications . . . . . . . . . . . . . . . . . . . . . . . . . 1-79 2.16.3 Maximum scan area (long x transverse) . . . . . . . . . . . . . 1-79 2.16.4 Programs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-80 2.16.5 Environmental specifications. . . . . . . . . . . . . . . . . . . . . . 1-80 2.16.6 Storage and transport environment. . . . . . . . . . . . . . . . . 1-81 2.16.7 X-ray generator (system no. DF+12000 and higher). . . . 1-81 2.16.8 X-ray generator (system no. DF+11999 and lower) . . . . 1-83 2.16.9 GE-LUNAR 8022 x-ray tube . . . . . . . . . . . . . . . . . . . . . . 1-85 2.16.10 GE-LUNAR 8743 x-ray tube head assembly (system no. DF+12000 and higher) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-86 2.16.11 LUNAR 6838 x-ray tube head assembly (system no. DF+11999 and lower) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-87 2.16.12 Laser specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-88 2.16.13 Compatible components . . . . . . . . . . . . . . . . . . . . . . . . 1-89 2.16.14 FDA Certified Components (USA Only) . . . . . . . . . . . . 1-89 2.17 Secondary Calibration / Daily QA . . . . . . . . . . . . . . . . . . . . . . . . . . 1-91 2.17.1 Secondary Calibration overview . . . . . . . . . . . . . . . . . . . 1-91 2.17.2 Starting the Daily QA (secondary calibration) . . . . . . . . . 1-91 Peak Test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-92 2.17.3 Tests Performed in the Secondary Calibration . . . . . . . . 1-92 2.17.4 QA Database. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-94 Figure 2-9. PRODIGY System Exploded View of External Covers and associated hardware . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-33 Figure 2-10. PRODIGY I NTC thermistor on the Primary Terminal Block1-35 Figure 2-11. PRODIGY I Power Distribution Block Diagram . . . . . . . . . 1-38 Figure 2-12. PRODIGY I (systems DF+11999 and lower) Block Diagram1-39 Figure 2-13. PRODIGY I (Systems DF+11999 and lower) Peripheral Configuration Block Diagrams . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-40 Figure 2-14. PRODIGY II System / Power Block Diagram . . . . . . . . . . . 1-41 Figure 2-15. Detector Block Diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-69 Figure 2-16. Detector Daughter Board Operation . . . . . . . . . . . . . . . . . 1-71 Figure 2-17. PRODIGY Detector Module . . . . . . . . . . . . . . . . . . . . . . . . 1-73 Figure 2-18. PRODIGY display panel. . . . . . . . . . . . . . . . . . . . . . . . . . . 1-75 Figure 2-19. Reference axis and target angles for tube head assembly 1-85 Figure 2-20. Anode heating/cooling curves . . . . . . . . . . . . . . . . . . . . . . 1-86 Figure 2-21. Cathode emission characteristics . . . . . . . . . . . . . . . . . . . 1-88 Figure 2-22. X-ray tube assembly heating/cooling curves . . . . . . . . . . . 1-88 Figure 2-23. PRODIGY Daily QA printout with expected values . . . . . . 1-95 Table 2-1. PRODIGY I (Systems DF+11999 and lower) Fuses . . . . . . . 1-42 Table 2-2. PRODIGY II (systems DF+12000 and greater) Fuses. . . . . . 1-42 Table 2-3. PRODIGY Component Specifications . . . . . . . . . . . . . . . . . . 1-79 This document contains confidential or proprietary information of GE-Lunar Corp. Neither the document nor the information therein is to be reproduced, distributed, used or disclosed, either in whole or in part, except as specifically authorized by GE-Lunar Corp.

PRODIGY Service Manual (Rev C - 2000)

System Overview 2-31

Table 2-4. X-ray generator technical information. . . . . . . . . . . . . . . . . . . 1-81 Table 2-5. Table 4. X-ray generator technical information. . . . . . . . . . . . 1-83 Table 2-6. LUNAR 8022 X-ray tube technical information. . . . . . . . . . . . 1-85 Table 2-7. LUNAR 8743 x-ray tube assembly technical information. . . . 1-86 Table 2-8. LUNAR 6838 x-ray tube assembly technical information. . . . 1-87 Table 2-9. Laser specifications.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-88 Table 2-10. FDA certified components (system no. DF+12000 and higher).189 Table 2-11. FDA certified components (system no. DF+11999 and lower).1-90

This document contains confidential or proprietary information of GE-Lunar Corp. Neither the document nor the information therein is to be reproduced, distributed, used or disclosed, either in whole or in part, except as specifically authorized by GE-Lunar Corp.

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PRODIGY Service Manual (Rev C - 2000)

2.0

PRODIGY System The PRODIGY includes the patient table and frame, X-ray tube, X-ray generator, detector, and arm. Its physical specifications are summarized in section 2.15. The PRODIGY has a mechanical design with two separate motion systems that are capable of simultaneous operation. These are transverse, and longitudinal. Both motion systems are driven by stepper motors.

2.0.1 PRODIGY Electronics The internal components of the scanner are safely secured by a number of panels, including the scanner's tabletop.

Figure 2-9. PRODIGY System Exploded View of External Covers and associated hardware • The front and side panels are secured by screws from the inside. • The rear panel is secured by screws from the outside. • The table top is screwed down from the top. Note:

Primary Service access to the electronics of the scanner is through the table top.

This document contains confidential or proprietary information of GE-Lunar Corp. Neither the document nor the information therein is to be reproduced, distributed, used or disclosed, either in whole or in part, except as specifically authorized by GE-Lunar Corp.

PRODIGY Service Manual (Rev C - 2000)

System Overview 2-33

• The Detector electronics (in the scan arm) are secured by an upper and lower shroud, held in place by screws. • Each metal panel is grounded to the electronics pan. It is not usually necessary to remove the front and back panels for most service needs. However, if access is needed to the Front and Rear Longitudinal Carriages, these can be removed. The back panel is secured by hex socket head-head screws and must be slid out of the way, for it is between the Arm Column and the frame. If access is needed to the detector, Transverse Limit Switches or the other components mounted above in the arm, the covers of the arm must be removed. • The upper scan arm shroud can be removed by loosening the two screws holding it in place (on the back of the arm column) and tipping it forward. • The lower cover is held in place by four screws, two in the front and two in the back, be sure to remove the ground wire for the metal portion of the lower cover as well

This document contains confidential or proprietary information of GE-Lunar Corp. Neither the document nor the information therein is to be reproduced, distributed, used or disclosed, either in whole or in part, except as specifically authorized by GE-Lunar Corp.

2-34 System Overview

PRODIGY Service Manual (Rev C - 2000)

2.1

Electronics 2.1.1 Cautions PRODIGY electronics are static sensitive, take static control precautions before servicing scanner circuitry.

PRODIGY I electronics use Negative Temperature Coefficient (NTC) thermistors to limit the in rush current of the AC isolation transformer and the Detector Mother Board. These devices have a high resistance when cold and decrease in resistance when warm.

Figure 2-10. PRODIGY I NTC thermistor on the Primary Terminal Block • A cool down period of 30 seconds is required before power is turned on on the system. PRODIGY I ONLY: Failure to allow the system to “cool down” may cause the circuit breaker for the AC line to trip and / or the + 12VDC for the Detector Mother Board (DMB) will not come up to +12 VDC. Note:

The error log entry "DMB Power Cycle observed" is an indicator that the DC power to the Detector Mother Board has been interrupted and the system should be powered down for 30 seconds to restore power to the Detector Mother Board. PRODIGY I ONLY: The NTC’s can get hot - they are located on the AC terminal block and on the DC terminal block be careful when servicing these areas of the scanner.

2.1.2 Electronics Pan This document contains confidential or proprietary information of GE-Lunar Corp. Neither the document nor the information therein is to be reproduced, distributed, used or disclosed, either in whole or in part, except as specifically authorized by GE-Lunar Corp.

PRODIGY Service Manual (Rev C - 2000)

System Overview 2-35

The electronic components of the PRODIGY are mounted on the grounded Electronics Pan which is horizontally fastened inside the frame. Note:

Appendix 2 A contains a layout drawing of the Electronics Pan for PRODIGY I and PRODIGY II systems.

PRODIGY I Systems (System numbers DF+11999 and lower): • There are four low-voltage linear DC power supplies (under 30VDC), and two high-voltage DC power supplies (to supply 76kV to the x-ray tube) on the pan. • In addition to the power supplies, the electronics mounting chassis holds four printed circuit boards, a stepper motor controller, the audible alarm, an AC entrance/line filter/fuse holder, an isolation transformer and a terminal strip for AC power distribution to the Host PC and peripherals.

PRODIGY II Systems (System numbers DF+12000 and greater): • There is one low-voltage DC switching power supply (under 30VDC), and one high-voltage DC power supply (x-ray generator - supplies 76kV to the x-ray tube) on the pan. • In addition to the power supplies, the electronics mounting chassis holds one printed circuit board, a stepper motor controller, and an AC entrance/ line filter/fuse holder.

2.1.3 Scan Arm • The scan arm contains one high-voltage power supply (1000VDC / +12 VDC input) is located in the upper arm near the X-ray detector and provides power to the Detector Array. • The scan arm also houses the detector and 5 associated printed circuit boards, and a stepper motor contoller.

2.1.4 Power specifications Leakage current • Total System with Isolation Transformer: 6.0 If the system you are installing Outlook 2002 on does not have the minimum required level of functionality, you will be prompted to update the Core System, Data Access Components and Web Browsing. If prompted to update, proceed with step 2, if not skip to step 4. 1. Insert the CD and wait for Autorun to launch. 2. If prompted to update, press Next. 3. From System Files Update Setup” drop down the selection menu and select “Do Not upgrade I.E and press Next. Reboot when prompted 4. Enter the Product key (found on the back of the case), and press Next. 5. Accept the Agreement and press Install. 6. From the Type of Installation screen, click Next. 7. Begin the installation by clicking Install. 8. When the install is complete, press OK, remove the CD and reboot the system. QUALITY SYSTEM DOCUMENT

Page 17 of 25

It is the responsibility of the user to verify this document originated from the controlled master and is the active revision prior to use. This document contains confidential or proprietary information of GE Lunar. Neither the document nor the information therein is to be reproduced, distributed, used or disclosed, either in whole or in part, except as specifically authorized by GE Lunar.

GE Medical Systems LUNAR

DOC ID: DXPC2000

REV: AP DATE: 12/19/02

CO: L10527

Refer to DXAP2030 for Setup Procedures. Q.

Remote Access Service Installation 1. Right click on the Network Neighborhood Icon and select Properties. 2. Click the Services Tab and press Add. 3. Select Remote Access Service and press OK. 4. Insert the WinNT CD when prompted (if Autorun Launches, close it) and press Continue. 5. From the “add RAS device” dialog box, verify the modem (56k fax internal PCI) is selected and press OK. 6. From Remote Access Setup, press continue. 7. Close the Network dialog box and press No when prompted to restart and Re-install the appropriate Service Pack. Refer to the Service Pack installation of Section A.

R.

Configure WinFax Pro (Modem software) •

Configuring Windows NT to use the fax modem. 1. In Windows NT Control Panel, (Start, Settings, Control Panel) double click the “Modems” icon. Verify that the 56K Fax INT” modem is present. If the “Modem is not present you will get the prompt asking if you want to install one. Follow the appropriate steps above. 2. Click on “Dialing Properties” and enter 608 as the area code. (The customer will have to change this later) Press Close, Close and Exit the Control Panel.

•

Installing WinFax PRO 1. Insert the WinFax installation CD and wait for autorun to display WinFax Pro Menu Screen. 2. Click Install. 3. At the Welcome Screen, press Next. 4. At the License Agreement Screen, press Yes. 5. Click Next at the User Information Screen. 6. Click Next at the Destination Folder Screen. 7. The Default Setup Type is Typical, Click Next. 8. Click Next at the Select Program folder. 9. Click Next at the Start Copying Files screen. 10. At the File Copy Complete screen, click Finish to reboot. 11. Click Next at the WinFax Pro Setup (CSID) screen. (Leave the fields blank)

QUALITY SYSTEM DOCUMENT

Page 18 of 25

It is the responsibility of the user to verify this document originated from the controlled master and is the active revision prior to use. This document contains confidential or proprietary information of GE Lunar. Neither the document nor the information therein is to be reproduced, distributed, used or disclosed, either in whole or in part, except as specifically authorized by GE Lunar.

GE Medical Systems LUNAR

DOC ID: DXPC2000

REV: AP DATE: 12/19/02

CO: L10527

12. At the “Modems and Other Fax Devices” screen, select the “56K FAX modem” from the modem and device list if it is not already selected and click Next. 13. Click Next to Test the Modem. 14. The results of the Test list the class and speed of the Modem. Click Next to continue. 15. With “Yes” selected in the “Enable Controller” dialog box, press Next. 16. From the Configure E-Mail screen, click Next. 17. Press Cancel at the Online Registration screen and Yes to “Are You Sure?” click Next. 18. From the Ready to Configure System screen, press Finish. 19. Answer NO to the Readme question. 20. Cancel the Live Update. 21. Select Yes to the Message Manager. 22. From the Phone book autolink screen, check Outlook 2000 and press OK. 23. Press Next at the Phone Book Name 24. Click on the Set Information button. 25. Click on the “Use Business Related Information” Radio button (if not already selected) and press OK. 26. Press Finish 27. After rebooting Windows NT and logging back on, verify that the fax icon appears on the status bar. 28. The WinFax Installation program has a bug in it. To correct it, Click Start, then Settings, and Printers. Right click on WinFax. Select Document Defaults from the Drop down list. Click the Advanced Tab. In the WinFax Document Settings dialog box, click on Print Quality. Click on Low Resolution Fax in the Change “Print Quality” Setting Box and click OK. Right click on WinFax and Select Document Defaults again. Change the Resolution back to Normal by clicking the Advanced Tab. In the WinFax Document Settings dialog box, click on Print Quality. Click on Normal Resolution Fax in the Change “Print Quality” Setting Box and click OK. 29. Close the Printers Dialog box and remove the CD •

Configuring AutoMentor 1. Subject to change.) Verify that you select WinFax as one of the available printers from within the application and that you can fax a patient report to Lunar service or some other destination. AutoMentor is not enabled at this time.

S. Setting the CD-ROM as the first Boot Device. QUALITY SYSTEM DOCUMENT

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It is the responsibility of the user to verify this document originated from the controlled master and is the active revision prior to use. This document contains confidential or proprietary information of GE Lunar. Neither the document nor the information therein is to be reproduced, distributed, used or disclosed, either in whole or in part, except as specifically authorized by GE Lunar.

GE Medical Systems LUNAR • • •

DOC ID: DXPC2000

REV: AP DATE: 12/19/02

CO: L10527

On boot up, Press [F2] to enter Setup. Press the → key 4 times to enter the Boot Menu. Press the ↓ key 7 times to the first Boot Device and press . Cursor down to the CD-ROM and press . Insert the Bootable CD (i.e. Windows NT Workstation) and press [F10] to save and exit setup. Windows Setup will initiate on boot up. Press at the Welcome screen, press enter at the “mass storage detection” screen, and skip to step # 10 of section A.

Default Boot Sequence • FDD • HDD • CD-ROM T.

PCI card slot assignment – (for PC’s with a Video Card) • PCI Slot 1: Adaptec SCSI Card (Optional) • PCI Slot 2: Virge Nitro 3D Video Card • PCI Slot 3: EtherLink Network Card (optional) • PCI Slot 4: SeaLevel Serial Card PCI card slot assignment – (for PC’s with on board Video and NIC) • PCI Slot 1: Adaptec SCSI Card (Optional) • PCI Slot 2: SeaLevel Serial Card • PCI Slot 3: Modem • PCI Slot 4:

U.

Creating the Image

Prior to creating the Final image (this is the image of the operating system setup with the Lunar Application software installed) verify/perform the following1. Empty the Recycle Bin. 2. Verify there are no errors from the last boot in the Event viewer (Start, Programs, Administrative Tools, Event viewer) 3. Verify DMA is Enabled. DMA Check is a small utility (NT only) used to enable/disable the DMA of the HDD. There is a copy on the network at R&D\Software(32Bit)\Utilities. Copy the file DMA check to a floppy disk, insert the disk in the PC being configured and using WindowsNT Explorer (click Start, Programs, WindowsNT Explorer), switch to the a: drive and double click on DMA check. Place a in both Enabled boxes. Press OK, then Yes to the Warning Message. Press OK at the Finished prompt. 4. For SP4 - Insert the EnCore OS Supplement v2 CD. (Exit the CD browser when Autorun launches). Using WindowsNT Explorer, copy the i386 folder from the NT4SP4a folder located on the EnCore OS Supplement v2 CD onto the Hard Disk. Rename this folder to SP4. QUALITY SYSTEM DOCUMENT

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It is the responsibility of the user to verify this document originated from the controlled master and is the active revision prior to use. This document contains confidential or proprietary information of GE Lunar. Neither the document nor the information therein is to be reproduced, distributed, used or disclosed, either in whole or in part, except as specifically authorized by GE Lunar.

GE Medical Systems LUNAR

DOC ID: DXPC2000

REV: AP DATE: 12/19/02

CO: L10527

5. For SP6 – Insert the EnCore product CD. (Exit the CD browser when Autorun launches). Using WindowsNT Explorer, copy the NT4SP6a folder from the EnCore product CD onto the Hard Disk. Rename this folder to SP6. 6. Using WindowsNT Explorer, create a folder on the Hard Disk called NT_Drivers and copy the following folders into it. Explore the “Technical Data” CD and Navigate to Drivers\MBA and open either the Ca810E folder or the 815 folder depending on which type of System board is in the PC. The System board type is displayed during the POST Boot. For the 845 board go to Drivers\NIC\846x. Copy the Networking folder to the folder you just created on the Hard Disk. Right click on the Networking folder. From the drop down menu, click on copy. Move the cursor to the Hard Disk (C:) and Right click on (C:\NT_Drivers). From the drop down menu, click on Paste. Right click on the Networking folder and rename it to Network. Close Explorer. 7. Using WindowsNT Explorer, copy the i386 folder from the WinNT 4.0 CD into the WinNT folder on the Hard Disk. 8. Insert the latest Production Master Application Software CD and install Dklite. After the installation is complete, defrag the HD by going to Start, Programs, Dklite. 10. All OmniTech PC models with on board LAN have networking installed. This means that you will receive an error message every time the system is booted (and every 6 minutes) if it is not connected to the Network. To avoid this message disable the DHCP Client. Go to “Start,Settings,Control Panel”. Double click on the Services Icon. Highlight “DHCP Client” and click on Startup. Click in the disabled radio button and press OK. Note: Prior to connecting a system to a LAN, the service must be re-enabled. 11. Refer to LUPC0006 to create the Image.

Section 2. Duplicating Product Software If the appropriate version of software is already loaded on the local hard disk, proceed with Step B. This can be verified by locating the appropriate folder named \product_X_XX_XXX on local hard drive; where product_X_XX_XXX is the product software version to be duplicated. A.

Creating Master Software on Duplicator PC. • • • • •

Insert product “Master Setup CD” into CD-ROM drive. Wait for Lunar CD Browser to start. Exit Lunar CD Browser. Create folder named \product_X_XX_XXX on local hard drive. Copy entire contents of product “Master Setup CD” into folder created above. • Wait for copy to complete and remove the “Master Setup CD” from the CD-ROM drive. QUALITY SYSTEM DOCUMENT Page 21 of 25 It is the responsibility of the user to verify this document originated from the controlled master and is the active revision prior to use. This document contains confidential or proprietary information of GE Lunar. Neither the document nor the information therein is to be reproduced, distributed, used or disclosed, either in whole or in part, except as specifically authorized by GE Lunar.

GE Medical Systems LUNAR • • • • • • • • B.

DOC ID: DXPC2000

REV: AP DATE: 12/19/02

CO: L10527

Start Adaptec Easy CD Creator. Select “Data CD” and press Select entire contents of the folder product_X_XX_XXX. Press to add the selected files and sub-folders to the CD layout. Press Select “Do not perform test” and press Select “Create CD later” and press Change CD label to product_X_XX_XXX using menu command “File|CD Layout Properties” Save CD layout as product_X_XX_XXX.cl3 using menu command “File|Save As”

Create Product CD. • • • • • • • • • •

Insert blank CD into CD-ROM drive. Start Adaptec Easy CD Creator. Press from the CD Creator Wizard Dialog. Open CD layout product_X_XX_XXX.cl3 using menu command “File|Open CD Layout”. Validate CD layout using menu command “File|Validate Layout” If errors are encountered, go to Step A of this section to restore required files. Start recording process using menu command “File|Create CD” Select option to: Test and create CD Select to start recording. Verify CD was created successfully.

Section 3. Configuring Application Software • • • • •

Check Sales Order for System Number and Application Sites. Get S/W Order Form FM03-4. Start Configurator. Enter System Number and select the options per the sales order. Do not enable any application that does not have okay to ship status unless approved by Regulatory Affairs. Review table below for latest status. If Regulatory Affairs approval is granted, then enable the application and add special “Investigation” label on software.

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GE Medical Systems LUNAR

DOC ID: DXPC2000

REV: AP DATE: 12/19/02

Application

DPX-MD+ Release Status

DPX-NT Release Status

Prodigy Pro Release Status

AP Spine Femur Total Body

Standard Standard Optional (Full-size Only) Optional Optional

Standard Standard Optional (Full-size Only) Optional Optional

Optional

Dual Femur Advanced Hip Assessment Pediatric Spine Pediatric Total Body Forearm oneVision Orthopedic Lateral HL7 Multiuser DB Teledensitom etry Dicom Lateral View Business Reports (encore composer) Physician Reports (encore composer) Animal body

All other Software Options

CO: L10527

Standard Standard Optional (Full-size Only) Standard Optional

Prodigy Oracle Release Status Standard Standard Standard (Full-size Only) Standard Optional

Prodigy Vision Release Status Standard Standard Standard (Full-size Only) Standard Standard

Optional

Optional

Optional

Optional

Optional

Optional

Optional

Optional

Optional

Optional Optional Optional Optional Optional Optional Optional

Optional Optional Optional Optional Optional Optional Optional

Optional Optional Optional Optional Optional Optional Optional

Optional Optional Optional Standard Optional Optional Optional

Standard Standard Optional Standard Optional Optional Standard

Optional Not Available Optional

Optional Not Available Optional

Optional Optional Optional

Optional Standard Standard

Standard Standard Standard

Optional

Optional

Optional

Standard

Standard

Not Available

Not Available

Internal use only

Internal use only

Optional. Need warning label 40122 Internal use only

Optional. Need warning label 40122 Internal use only

Optional. Need warning label 40122 Internal use only

Note: Compact systems do not require a configuration feature code. They are configured in the field at the time of install using Service Options.

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GE Medical Systems LUNAR

DOC ID: DXPC2000

REV: AP DATE: 12/19/02

CO: L10527

Serial and System numbers: First Scanner Number

First System Number

70001 70101 72001 72101 73001 73101

NT+70000 NT+70000 NT+72000 NT+72100 NT+73000 NT+73100

DPX-NT (DPX-MD+) NTA Beta NTA Production NTB Beta NTB Production NTC Beta NTC Production DPX-NT 180 (DPX-MD+ 180) NTB-180 Beta NTB-180 Production NTC-180 Beta NTC-180 Production

90001

NT-90101

91001 91101

NT-91000 NT-91100

Prodigy Prodigy 1 Beta Prodigy 1 Production Prodigy 2 Beta Prodigy 2 Production Prodigy 3 Beta Prodigy 3 Production Prodigy 4 Beta Prodigy 4 Production

60001 60101 62001 62101 63001 63101 64001 64101

DF+10001 DF+10001 DF+12000 DF+12100 DF+13001 DF+13101 DF+14001 DF+14101

Prodigy Compact Prodigy 3 Compact Beta 80001 DF-80001 Prodigy 3 Compact Production 80101 DF-80101 Prodigy 4 Compact Beta 81001 DF-81001 Prodigy 4 Compact Production 81101 DF-81101 Note, in each system number, the plus or minus symbol is used to denote total body option availability. This has been for historical purposes. Configurator is not conditionally tied to this convention. Application Production Release Limited release for user tests at early adopter sites

DPX-MD+ Release Status 6.70.021 on NT hardware None

QUALITY SYSTEM DOCUMENT

DPX-NT Release Status 6.70.021

None

Prodigy Release Status 6.70.021

None

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GE Medical Systems LUNAR • • • • • •

DOC ID: DXPC2000

REV: AP DATE: 12/19/02

CO: L10527

Configurator program automatically generates the feature code. Select required printer, using menu command “File|Printer Setup”, to Epson FX-880. Print three labels. Remove labels and place one on the S/W Production Form in the designated area. Place the second label on the CD Diskette sleeve. Place the third label on the PC Form. Using Copy/Paste (Ctrl C/Ctrl V), take feature code from configuration and paste into Filemaker DB program. Fill out paperwork associated with software order form.

Note: Internal QA/Production software should be configured as System Number 00002 with all sites enabled.

GENERATED RECORDS DXPC2001 FM03-4

DPX Fan PC Configuration Form Software Order Form

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g

MANUFACTURING PROCEDURES GE Medical Systems LUNAR

DOC. ID: DXAP2011 REVISION: B DATE: 8/13/01 WRITTEN BY: Jeff Franz APPROVED ON CO: 7012

TITLE: enCORE Beam Wobble Procedure

PURPOSE This procedure describes the steps necessary to perform the Beam Wobble scan for Prodigy or DPX-NT systems.

APPLICATION This procedure applies to all employees performing installation or service of Prodigy scanners with version 2.26 or greater software.

SAFETY PRECAUTIONS The x-ray generator produces a beam of ionizing radiation. The technician should take precautions to avoid exposing any part of their body to the x-ray beam.

ASSOCIATED MATERIALS DXAP2000 DXAP2004 DXAP200x

Prodigy Installation Instructions Prodigy Installation Report Prodigy Source Detector Alignment

DEFINITIONS None.

PROCEDURES 1.

LIMIT TO LIMIT TEST A.

Remove the scanners table top (if not already removed).

B.

Enter the Service Mode of the Fan Software Options / User Options Service – Enter Password (Smile sw ver 1.0 – 2.05 or Award ver 2.10 +)

C.

Insure that the Front, Head and Foot Panels are minimally hanging on the scanner frame.

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GE Medical Systems LUNAR D.

DOC ID: DXAP2011

REV: B

DATE: 8/13/01

CO: 7012

Run the limit to limit test with the configure box checked to establish the scan window. 1. Select Tools / Diagnostics / Scanner Motion 2. Click on the configure box – there will be a check mark in the box when it is selected. 3. Click on Start in the limit to limit box 4. While the Limit to Limit test is running be sure to listen and look for anything that is binding or impeding the mechanics of the scanner. In particular: - Tube head and shutter assembly must clear tabletop and carriage bracket bolts. - Shutter assembly wiring should be correct and wire tied so they do not catch on anything - Especially watch for binding while the scan arm is moving to home position. The Molex connector of the collimator assembly may hang up, causing the scanner to jerk when moving off of the limit switch. - Also verify that the arm slot cover is not slipping out of the guides when the scan arm is at the head and foot of the scan table. - The height of the High Voltage cable trough must be low enough so that the High Voltage cables do not get hung up on the stepper motor drive (CENTENT) but not so low as to cause the high voltage cables to bind. - Insure that all moving parts are traveling to their limits without restriction or impediment. 5. Check the limit to limit values against the table below.

Direction Longitudinal Transverse

Steps 19875 12475

Tolerance +/- 25 +/- 25

6. If any of the limit to limit distances are out of spec perform the steps below, if values pass go to step 7. I. II.

If the front panel is on the scanner, remove it. Go to Tools\Diagnostics\Scanner Motion

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GE Medical Systems LUNAR III.

DOC ID: DXAP2011

REV: B

DATE: 8/13/01

CO: 7012

Click on Move to Home - Place the "Home Position" jig in the home corner. Verify the hole in the collimator lines up with the hole in the jig as in figure 1.

FIGURE 1: Home position Jig – verifying home position IV.

If home position does not match the Home position Jig, adjust the limit switch positions using the service software as illustrated in step A below. If home position does not need to be adjusted, proceed to step V. a. Go to Tools/Diagnostics/Limit Switch Adjustment b. Follow the on Screen prompts – DO NOT EDIT THE DEFAULT VALUES c. If limit switch positions are altered a Limit to Limit test (see VI below) must be run with the configure box checked to recalibrate the scanners range of motion.

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GE Medical Systems LUNAR

DOC ID: DXAP2011

REV: B

DATE: 8/13/01

CO: 7012

V.

Replace all exterior scan table panels (see DXAP2000 – Figure 9 for panel placement and fastener selection), with the exception of the arm shrouds.

VI.

In the Service software, go to Tools / Diagnostics / Scanner Motion. Check the configure box and then Run the Limit to Limit Test by clicking on the Start button for Limit to Limit verify that the Step Values for longitudinal and transverse are within tolerance.

NOTE: If the scan window is altered in any way (limit switch moved – scanner is reassembled) the Limit to Limit Test must be run with the configure box checked. 7. Run a second limit to limit test with approximately 250 lbs (150kg) of weight on the table top, check for binding in the arm slot cover at this time. 8. Click on Close

2.

PERFORM BEAM WOBBLE A. B. C. D.

Select Measure – use the patient Phantom Spine – if the patient does not exist enter the following information Enter patient information for Spine Phantom (if it has already been entered, go to step E). Enter the Directory by selecting the Directory F4 button from the main screen. Open the New Patient dialog by clicking the New button on the Directory toolbar.

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GE Medical Systems LUNAR

DOC ID: DXAP2011

REV: B

DATE: 8/13/01

CO: 7012

Figure 2: New Patient Dialogue Box with Spine Phantom Patient information entered in the appropriate fields. E.

Enter the patient information as illustrated in figure 2.

F.

Click OK to close the dialog and save the new patient information.

G.

Double-click the Spine Phantom patient in the Patient List to enter the New Measurement screen.

H.

Click on Beam Wobble in the Site box (it will be highlighted blue when it is selected)

I.

Verify that the table top is off and there are no objects positioned around the table that might impede scanner motion

J.

Click on position in the tool bar at the top of the screen

K.

Allow the scanner to acquire reference counts in the center of the table – make sure the alignment aperture is not present.

L.

When prompted, place the alignment aperture on to the collimator, then click OK.

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GE Medical Systems LUNAR

DOC ID: DXAP2011

REV: B

DATE: 8/13/01

CO: 7012

M.

When the scanner returns home, click on Start and allow the Beam Wobble scan to run. It will take approximately 6 minutes.

N.

When the test is complete it will be analyze it by clicking on the analyze button on the tool bar.

O.

Select the Spine Phantom patient from the list and then double click on the appropriate Beam Wobble file. a. Verify that the TEST RESULTS – Test Outcome = Pass b. If the test does not pass, look at the image, it should look essentially like a random distribution of gray. c. White areas with an outline indicate areas where alignment problems exist.

Figure 2: Failing Beam Wobble Image – Alignment Aid showed that the beam was biased toward detector 1 (head) – Alignment aid showed good alignment in all other areas of the scan table. Lowering the front foot corner with the glide improved the alignment in Alignment Aid. QUALITY SYSTEM DOCUMENT

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GE Medical Systems LUNAR

DOC ID: DXAP2011

REV: B

DATE: 8/13/01

CO: 7012

d. To correct these areas of mis-alignment: 1. Verify table level 2. Verify that nothing is impeding scanner motion 3. Verify count rate / alignment in Signal Monitor or Alignment Aid in the problem areas of the scan table. 4. Adjust Table level / alignment as necessary. 5. Re-Run the Beam Wobble test 6. If the Beam Wobble test fails a second time perform DXAP2006 Prodigy Dial Indicator Alignment Verification Procedure. NOTE: If anything passes through the beam during this test, IT WILL FAIL. P.

When passing results have been achieved, print the results by clicking on the Print button on the toolbar.

Q.

When the Beam Wobble has been completed return to DXAP2001 step 7-A to complete the alignment.

GENERATED RECORDS None.

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g

DOC. ID: DXAP2030 MANUFACTURING PROCEDURES GE Medical Systems LUNAR

REVISION: D DATE: 3/1/02 WRITTEN BY: Tom Bergman APPROVED ON CO: L10181

TITLE: Teledensitometry Configuration Procedure

PURPOSE This procedure is used to setup the Teledensitometry kit and any optional software for Prodigy and DPX-NT.

APPLICATION This procedure applies to certain LUNAR validated PC’s and software (Granite Microsystems where applicable and OmniTech computers). It can be used as a guideline for installing hardware and software in other computers, however there is no guarantee that this procedure will in fact work with other PCs. Execute appropriate procedural steps based on the model of PC to be configured and the number of additional Teledensitometry options ordered by the site. •

If the hardware setup is to be performed on a system running Windows XP, follow section 6. Note: After setting up Outlook, the customer should be strongly encouraged to archive their mail on a weekly basis. This backup should place the archived file on the D: drive. In the event a customer uses the recovery image and they have not archived their mail to the D: drive, it will be lost including all contacts.

•

If the hardware setup is to be performed on a Prodigy system, follow section 1.

•

If the hardware setup is to be performed on a DPX-NT system, follow section 2.

•

If the hardware is already setup and you need to install Microsoft Outlook 2000 software, follow section 3.

•

If the hardware is already setup and you need to install WinFax Pro software, follow section 4.

•

If the hardware is already setup and you need to install WinFax Pro software and/or other Teledensitometry options, follow section 4 (SETTING UP WINFAX PRO SOFTWARE) and section 5 (SETTING UP TELEDENSITOMETRY SOFTWARE).

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GE Medical Systems LUNAR

DOC ID: DXAP2030

REV: D

DATE: 3/1/02

CO: L10181

SAFETY PRECAUTIONS None.

ASSOCIATED MATERIALS LUNAR enCORE™ Operator’s Manual P/N 8543 LUNAR Ambassador HL7 Interface Configuration Manual P/N 8596 LUNAR DICOM Operator’s Manual P/N 17663 Setting up a Multi-User Database DXPC2000 DPX-Fan/DPX-NT PC Configuration Procedure

DEFINITIONS None.

PROCEDURES Section 1. INSTALLING HARDWARE IN PCs CONNECTED TO PRODIGY A. Installing Optional Interface Cards Note: OmniTech computers require some alterations prior to installing interface cards. If both a modem and a Network adapter are being installed, the Audio must be disabled in the BIOS. Turn on the PC and enter the BIOS by pressing F2 when prompted. Cursor to Advanced, select Peripherals and disable the Audio by highlighting Audio and pressing Enter. Select Disable and press Enter. Exit by pressing F10, save the configuration and let the PC boot. Remove the Audio drivers by double clicking on Multimedia from the Control Panel. Click on the Devices Tab, and click the + by the Audio Devices. Highlight the Driver and click Remove. Click Yes to the warning message. This will eliminate the service failure message displayed during NT startup. There are two possible types of modems that can be in the Teledensitometry kit, ISA or PCI. If there are jumpers on the card it is an ISA, if not it is a PCI card. For ISA modems go to step B, for PCI modems go to step C. B. Install (ISA) Modem Card and Drivers All new systems are purchased with the SeaLevel card installed as Com3. If a modem is being added, follow the steps below:

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GE Medical Systems LUNAR

DOC ID: DXAP2030

REV: D

DATE: 3/1/02

CO: L10181

1. Jumper the modem for Com3, IRQ 4 and install it in the outermost ISA slot. 2. Login in as Administrator and install the modem drivers by going to the Control Panel and double clicking on the Modem Icon. Check the “Don’t detect my Modem “ box and click Next. i. Omni-Tech Systems 1. Insert the CD supplied from OTC (Technical Information and Data) and click Have Disk. Switch to the CD drive and click Browse. Double click on Drivers|MDI|USRB. Click Open then OK. In the Manufacturers box, click U.S. Robotics Access Corp. and select the 56k fax internal modem and click Next. Select Com3 as the port to install the drivers on and click Next. Click Finish and from the Modem Properties Dialog box, click Dialing Properties and enter the Area Code. Click OK, Close.

3. Prodigy only: Use Advanced Ports from the Control Panel and change the second Com3 port to COM4. Click OK and let the computer reboot. 4. Prodigy only: Use Advanced Ports again and Verify COM4 is a valid PCI port. Select Cancel to avoid the reboot prompt. 5. Prodigy only: When opening the Prodigy program you will receive an error message stating a “750 Serial card has been detected” or incorrect Serial Port configuration. This is because the software is by default, set to Com3. You must go into Service Options and set the Port to Com4. 6. To test the Modem, use Phone Dialer found in Programs\Accessories. 7. To load WinFax Pro software go to Section 3. C. Install (PCI) Modem Card and Drivers Note: The 3Com PCI modem is installed using a default address and a default IRQ. These should not be changed unless you are certain there will be no conflicts. For PCs in the field that already have Microsoft Windows-NT Service pack 6 installed, Go to Step 1. For PCs with Service Pack 4 go to step 3. 1. Remove the SeaLevel Serial card drivers by going to Start|Settings|Control Panel. Select Add/Remove Programs, Highlight SUD Setup and then select Add/Remove. After the serial drivers have been removed close the Add/Remove Programs screen. Restart the PC. QUALITY SYSTEM DOCUMENT

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GE Medical Systems LUNAR

DOC ID: DXAP2030

REV: D

DATE: 3/1/02

CO: L10181

2. Go to Start|Settings|Control Panel, select Ports. Highlight Com 3 and select Delete. Exit Control Panel and power down PC. 3. Install the Modem in slot 3. i. Omni-Tech Systems 1. Insert the supplied OTC Technical Data CD (ver 1.41 or >) and wait for the “Autorun” to launch. Exit the autorun program on the CD. Click Start|Run and Browse. Navigate to \Drivers\MDI\3com and run Setup. Reboot when prompted. After a successful reboot you may enter setup (BIOS) and re-enable the Audio (if disabled in step 2). 2. If you have removed the SeaLevel drivers in step C.1. you must reinstall them now by inserting the Prodigy CD in the CDROM drive, wait for autorun to launch and select option #1-Serial drivers version XXX. 4. Prodigy only: Use Advanced Ports from the Control Panel and Verify COM4 is a valid PCI port. Press Cancel to avoid the reboot prompt. 5. Prodigy only: When opening Prodigy you will receive an error message stating a “750 Serial card has been detected” or incorrect Serial Port configuration. This is because the software is by default, set to Com3. You must go into Service Options and set the Port to Com4. i. Go to Tools|User Options|Systems tab. ii. Check the Service checkbox and enter in the appropriate password. Select OK. iii. Go to Tools|Service Options|Serial tab. iv. Change the Com port to 4. v. Select OK to close. vi. Exit Prodigy software. 6. To test the Modem, use Phone Dialer found in Accessories. 7. To Load WinFax Pro software proceed to Section 3. D. Adding a Network Interface Card (NIC) to an existing system NOTE: There must be a functional network connection in order for the installation of Windows Networking to be tested. Consult with the customer’s IS department, or Network person, to determine the protocols and services required. If a workgroup (no server) is used then the specific TCP/IP address will have to be known before installing the NIC. If a DHCP Server is used, then a Computer Name and Domain must be known before installing the NIC. The Computer Name must match the one given by the Network Administrator. To change the Computer Name, Right click on Network Neighborhood from the Desktop. Answer “No” to setting up the network QUALITY SYSTEM DOCUMENT

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GE Medical Systems LUNAR

DOC ID: DXAP2030

REV: D

DATE: 3/1/02

CO: L10181

now. Go to Properties| Identification and Change. Edit the Computer Name. Do not reboot the computer now, rather shutdown and install the NIC. Follow the appropriate steps below. DICOM and HL7 features require TCP/IP protocol and default Windows Networking services to function properly. There are two types of NIC’s. A PCI NIC and an on-board NIC. To install networking with the on-board NIC go to step 2. 1. Insert the PCI NIC in PCI slot #3. 2. Connect the network cable. 3. Power-up the computer and login as the Administrator. i. For Omnitech computers with a PCI NIC: 1. Copy the 3C90X folder (found on the OTC Technical Data CD version 1.41 or greater) from \drivers\NIC\3com\ to the root on the C drive before starting the network install. 2. Insert the Windows NT CD in to the CD ROM drive. If the autorun program starts, cancel out of it and leave the CD in the drive. You will need it in step 5 Win NT setup. ii. For OmniTech computers with an on-board NIC: 1. Networking will already be installed on the PC. A DHCP Client will have been chosen but turned off to avoid the PC from trying to connect to a network every 6 minutes. To reenable the DHCP Client go to Start|Settings|Control Panel. Select the Services icon by double clicking on it. Select DHCP Client and select Startup. Select the Automatic radio button and select OK. Select Start to start the service. Go to section 3. 4. Double-click the Network icon in the Control Panel and confirm the installation of Windows Networking. If Windows Networking has not yet been set up you will receive a message that “Windows NT Networking is not installed. Do you want to install it now?” Select “Yes” and continue. 5. Select “Wired to the network” and press Next. 6. At the Network Setup Wizard screen, choose “Select from list”. 7. At the Select Network Adapter screen, choose “Have Disk”. 8. At the Insert Disk take the appropriate action based on the type of Ethernet adapter. i. For a PCI NIC type c:\3c90x and select OK. ii. For an on-board NIC type c:\lan and select OK. 9. The OEM option screen should state `you have selected either the 3Com EtherLink PCI NIC or the Intel 82559 Fast Ethernet LAN on Motherboard. Select OK to continue. QUALITY SYSTEM DOCUMENT

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GE Medical Systems LUNAR

DOC ID: DXAP2030

REV: D

DATE: 3/1/02

CO: L10181

10. Select Next to continue at the Network Setup/Network Adapters screen. 11. At the Network Protocols screen, make sure TCP/IP Protocol is checked and select Next to continue. 12. At the Network Services screen all options will be checked. Select Next to continue. 13. Select Next to install the selected components. 14. At the Windows NT Setup screen it will state “Setup needs to copy some Windows NT files.” Make sure that the Windows NT CD is in the CD ROM drive. If the autorun program starts, exit the autorun program and get back to the Windows NT Setup screen. Type: x:\i386 (where “x” is the drive designator of the CD ROM drive. Select Continue. 15. The TCP/IP Setup screen will appear. It will state that “If there is a DHCP server on your network TCP/IP can be configured… If you have a DHCP server, select Yes to continue. If not, select No and continue. 16. If you selected Yes, the Network Setup Wizard will start copying files from the Windows NT CD. If you selected No, you are then given the opportunity to input a specific IP address. This information will be provided by the IS personnel on site. 17. Select all services and then select Next. 18. Windows will now be ready to start the network. Select Next. 19. If a DHCP server has been chosen then the Install Wizard will ask for the Computer Name, Workgroup and/or Domain. Make sure the Computer Name matches the one given on the network by IS personnel. It cannot be changed in this screen. Follow the onscreen directions and select Next. 20. Select Finish and Networking should be installed. 21. Remove the Microsoft Windows NT CD from the drive. 22. Click Yes to restart the computer to complete the network configuration. 23. Login as administrator. 24. Error messages may appear indicating failure of services during startup. Dismiss these errors and continue with the following step. 25. Re-apply NT Service Pack 6 to update any files that were copied from the NT 4.0 Workstation CD. Use Windows Explorer to look for Service Pack 6 on the C drive. If Service Pack 6 is on the C drive it will be in a folder called C:\SP6. If you do not find this folder, use the enCORE Operating System Supplement CD ROM disk provided with the Teledensitometry kit. Follow the instructions in step E to reapply Service Pack 6. E. Windows NT 4.0 Service Pack 6 Installation – 40 Bit Security (not required for preloaded systems) 1. Insert the enCORE Operating System Supplement CD in the CD ROM drive. Wait for Autorun to launch and display the LUNAR browser menu 2. Select option 1 Install NT 4.0 SP6 - English. Service Pack 6 will be installed and the PC will restart automatically. QUALITY SYSTEM DOCUMENT

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GE Medical Systems LUNAR

DOC ID: DXAP2030

REV: D

DATE: 3/1/02

CO: L10181

Wait for the PC to boot up completely and remove the CD from the drive.

Section 2. INSTALLING HARDWARE IN PCs CONNECTED TO DPX-NT A. Installing Optional Interface Cards Note: OmniTech computers require some alterations prior to installing interface cards. If both a modem and a Network adapter are being installed, the Audio must be disabled in the BIOS. Turn on the PC and enter the BIOS by pressing F2 when prompted. Cursor to Advanced, select Peripherals and disable the Audio by highlighting Audio and pressing Enter. Select Disable and press Enter. Exit by pressing F10, save the configuration and let the PC boot. Remove the Audio drivers by double clicking on Multimedia from the Control Panel. Click on the Devices Tab, and click the + by the Audio Devices. Highlight the Driver and click Remove. Click Yes to the warning message. This will eliminate the service failure message displayed during NT startup. There are two possible types of modems that can be in the Teledensitometry kit, ISA or PCI. If there are jumpers on the card it is an ISA, if not it is a PCI card. For ISA modems go to step B, for PCI modems go to step C. B. Install (ISA) Modem Card and Drivers 1. Jumper the modem for Com3, IRQ 4 and install it in the outermost ISA slot. 2. Login in as Administrator and install the modem drivers by going to the Control Panel and double clicking on the Modem Icon. Check the “Don’t detect my Modem “ box and click Next. i. Omni-Tech Systems 1. Insert the CD supplied from OTC (Technical Information and Data) and click Have Disk. Switch to the CD drive and click Browse. Double click on Drivers|MDI|USRB. Click Open then OK. In the Manufacturers box, click U.S. Robotics Access Corp. and select the 56k fax internal modem and click next. Select Com3 as the port to install the drivers on and click next. Click Finish and from the Modem Properties Dialog box, click Dialing Properties and enter the Area Code. Click OK, Close. 3. To test the Modem, use Phone Dialer found in Accessories. QUALITY SYSTEM DOCUMENT

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GE Medical Systems LUNAR

DOC ID: DXAP2030

REV: D

DATE: 3/1/02

CO: L10181

4. To Load WinFax Pro software go to Section 3. C. Install (PCI) Modem Card and Drivers Note: The 3Com PCI modem is installed using a default address and a default IRQ. These should not be changed unless you are certain there will be no conflicts. 1. Install the Modem in slot 3 2. If both a modem and a Network adapter are being installed, follow the directions above in Section 2. A. 3. Insert the supplied OTC Technical Data CD (ver 1.41 or >) and wait for the “Autorun” to start. Click Exit in the lower Right hand corner. Select Start and then Run. Type in X:\Drivers\MDI\3com\Setup.exe. (Replace X: with your CD-ROM drive letter). Click OK. 4. Select Install to start the installation. 5. Select Yes to Restart. (On reboot enter setup and re-enable the Audio (if disabled in step 2). 6. Remove the CD. 7. To Load WinFax Pro software go to Section 3. D. Adding a Network Interface Card (NIC) to an existing system There must be a functional network connection in order for the installation of Windows Networking to be tested. Consult with the customer’s IS department, or Network person, to determine the protocols and services required. If a workgroup (no server) is used then the specific TCP/IP address will have to be known before installing the NIC. If a DHCP Server is used, then a Computer Name and Domain must be known before installing the NIC. The Computer Name will have to be changed to match the one given by the Network Administrator. To change the Computer Name, Right click on Network Neighborhood from the Desktop. Answer No to setting up the network now. Go to Properties| Identification and Change. Edit the Computer Name. Do not reboot the computer now, rather shutdown and follow the appropriate steps below. DICOM and HL7 features require TCPIP protocol and default Windows Networking services to function properly. There are two types of NIC’s. A PCI NIC and an on-board NIC. To install networking with the on-board NIC go to step 2. 2. Insert the Ethernet adapter in PCI slot #3. 3. Connect the network cable. 4. Power-up the computer and login as the Administrator. ii. For Omnitech computers with a PCI NIC: 1. Copy the 3C90X folder (found on the OTC Technical Data CD version 1.41 or greater) from \drivers\NIC\3com\ to the root on the C drive before starting the network install. QUALITY SYSTEM DOCUMENT

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GE Medical Systems LUNAR

DOC ID: DXAP2030

REV: D

DATE: 3/1/02

CO: L10181

2. Insert the Windows NT CD in to the CD ROM drive. If the autorun program starts, cancel out of it and leave the CD in the drive. You will need it in step 12 for Win NT setup. iii. For OmniTech computers with an on-board NIC: 1. Networking will already be installed on the PC. A DHCP Client will have been chosen but turned off to avoid the PC from trying to connect to a network every 6 minutes. To reenable the DHCP Client go to Start|Settings|Control Panel. Select the Services icon by double clicking on it. Select DHCP Client. Select the Automatic radio button and select OK. Select Start to start the service. Go to section 3.

5. Double-click the Network icon in the Control Panel and confirm the installation of Windows Networking. If Windows Networking has not yet been set up you will receive a message that “Windows NT Networking is not installed. Do you want to install it now?” Select Yes and continue. 6. Select Wired to the network and select Next. 7. At the Network Setup Wizard screen, choose “Select from list”. 8. At the Select Network Adapter screen, choose “Have Disk”. a. At the Insert Disk take the appropriate action based on the type of Ethernet adapter. i. For a PCI NIC type c:\3c90x and select OK. ii. For an on-board NIC type c:\lan and select OK. 8. The OEM option screen should state `you have selected either the 3Com EtherLink PCI NIC or the Intel 82559 Fast Ethernet LAN on Motherboard. Select OK to continue. 9. Select Next to continue at the Network Setup/Network Adapters screen. 10. At the Network Protocols screen, make sure TCP/IP Protocol is checked and select Next to continue. 11. At the Network Services screen all options will be checked. Select Next to continue. 12. Select Next to install the selected components. 13. At the Windows NT Setup screen it will state “Setup needs to copy some Windows NT files.” Make sure that the Windows NT CD is in the CD ROM drive. If the autorun program starts, exit the autorun program and get back to the Windows NT Setup screen. Type x:\i386 (where “x” is the drive designator of the CD ROM drive. Select Continue. 14. The TCP/IP Setup screen will appear. It will state that “If there is a DHCP server on your network TCP/IP can be configured… If you have a DHCP server, select Yes to continue. If not, select No and continue. 15. If you selected Yes, the Network Setup Wizard will start copying files from the Windows NT CD. If you selected No, you are then given the QUALITY SYSTEM DOCUMENT

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GE Medical Systems LUNAR

DOC ID: DXAP2030

REV: D

DATE: 3/1/02

CO: L10181

opportunity to input a specific IP address. This information will be provided by the IS personnel on site. 16. Select all services and then select Next. 17. Windows will now be ready to start the network. Select Next. 18. If a DHCP server has been chosen then the Install Wizard will ask for the Computer Name, Workgroup and/or Domain. Make sure the Computer Name matches the one given on the network by IS personnel. It cannot be changed in this screen. Follow the onscreen directions and select Next. 19. Select Finish and Networking should be installed. 20. Remove the Microsoft Windows NT CD from the drive. 21. Select Yes to restart the computer to complete the network configuration. 22. Login as administrator. 23. Error messages may appear indicating failure of services during startup. Dismiss these errors and continue with the following step. 24. Re-apply NT Service Pack 6 to update any files that were copied from the NT 4.0 Workstation CD. Use Windows Explorer to look for Service Pack 6 on the C drive. If the SP6 folder is on the HDD, you can install it by going to C:\SP6\Update. Click on Update.exe. From the Welcome screen, Accept the License Agreement, deselect Backup and press install. If the SP6 folder is not on the HDD, proceed with step 1. If you do not find this folder, use the enCORE product CD.Follow the instructions in step E to reapply Service Pack 6. E. Windows NT 4.0 Service Pack 6 Installation – 40 Bit Security (not required for preloaded systems) 1. 2.

3.

Insert the product software CD. Wait for Autorun to launch and display the LUNAR browser menu. Click exit and start Explorer. Navigate to NT4sp6a\Update. Click on Update.exe. From the Welcome screen, Accept the License Agreement, deselect Backup and press install. Restart the PC when prompted. Wait for the PC to boot up completely and remove the CD from the drive.

Section 3. SETTING UP MICROSOFT OUTLOOK 2000/2002 B. Installing Outlook 2000 1. 2.

Insert the Microsoft Outlook 2000 CD into the CD ROM drive and wait for Autorun to launch. At the Welcome screen, enter the Customers name and the Key Code and select Next.

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GE Medical Systems LUNAR 3. 4. 5. 6.

7. 8. 9.

DOC ID: DXAP2030

REV: D

DATE: 3/1/02

CO: L10181

Click on I accept the terms in the License Agreement and select Next. Select Customize. From the Install Location dialog box, select Next. From the Updating Windows dialog box, click the drop down menu arrow and select “Do not upgrade Microsoft Internet Explorer” and select Next. From the Selecting Features window, click on the yellow 1 by Symantec Fax starter; select Not available then select Install Now. Wait for the files to be copied successfully and select Yes to restart when prompted. Remove the CD from the drive.

C. Installing Outlook 2002 Note: Version >6.0 If the system you are installing Outlook 2002 on does not have the minimum required level of functionality, you will be prompted to update the Core System, Data Access Components and Web Browsing. If prompted to update, proceed with step 2, if not skip to step 4. 1. Insert the CD and wait for Autorun to launch. 2. If prompted to update, press Next. 3. From System Files Update Setup” drop down the selection menu and select “Do Not upgrade I.E and press Next. Reboot when prompted 4. Enter the Product key (found on the back of the case), and press Next. 5. Accept the Agreement and press Install. 6. From the Type of Installation screen, click Next. 7. Begin the installation by clicking Install. 8. When the install is complete, press OK, remove the CD and reboot the system.

New Outlook 2000/2002 Setup: If Remote Access Service (RAS) is installed, go to the appropriate section, either F or G. You can verify that RAS has been installed by right clicking on the Network Neighborhood Icon and selecting Properties. Select the Services Tab to see which services are installed. D. Remote Access Service Installation 1. 2. 3.

Right click on the Network Neighborhood Icon and select Properties. Click the Services Tab and select Add. Select Remote Access Service and select OK.

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GE Medical Systems LUNAR 4. 5. 6. 7. 8. 9.

DOC ID: DXAP2030

REV: D

DATE: 3/1/02

CO: L10181

Insert the WinNT CD when prompted (if Autorun Launches, close it) and select Continue. From the “add RAS device” dialog box, verify the modem (56k fax internal PCI) is selected and select OK. From Remote Access Setup, select continue. From the Network dialog box select Close. Select No when prompted to restart. Install SP6.

E. Installing Windows-NT Service Pack 6 Note: If the SP6 folder is on the HDD, you can install it by going to C:\SP6\Update. Click on Update.exe. From the Welcome screen, Accept the License Agreement, deselect Backup and press install. If the SP6 folder is not on the HDD, proceed with step 1. 1. 2.

3.

Insert the product software CD. Wait for Autorun to launch and display the LUNAR browser menu. Click exit and start Explorer. Navigate to NT4sp6a\Update. Click on Update.exe. From the Welcome screen, Accept the License Agreement, deselect Backup and press install. Restart the PC when prompted. Wait for the PC to boot up completely and remove the CD from the drive.

F. New Outlook 2000 Setup 1. 2. 3.

Double Click on the Outlook 2000 Icon. From the Outlook 2000 Startup screen select Next. From the E-mail Service Options screen select Internet Only then select Next. 4. From the “Your Name” dialog box, enter the customers name and select Next. 5. From the “E-Mail Address” dialog box, enter the customers E-mail address and select Next. 6. From the “E-Mail Server Names” dialog box, enter the Server type and Incoming and Outgoing Servers and select Next. 7. From the “Internet Mail Login screen, have the customer enter their E-mail password (and name if necessary) and select Next. 8. From the Friendly Name dialog box select Next. 9. Choose the appropriate connection type and select Next. Most likely a Phone Line (Modem) connection. 10. Enter the location information (area code) and select Close. 11. Enter the Telephone number used to connect to the ISP and select Next.

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GE Medical Systems LUNAR

DOC ID: DXAP2030

REV: D

DATE: 3/1/02

CO: L10181

12. Enter the User Name and Password used to login to the Internet and select Next. 13. From the Advanced Settings screen, select Next. 14. At the Dial-up connection Name dialog box, enter a name for the connection (e.g. the ISP), and select Next. 15. Select Finish. 16. Select Yes to accept Outlook as the Default Manager. G. New Outlook 2002 Setup

enCORE v6.0 or newer

1. 2. 3. 4.

Double Click on the Outlook 2002 Icon. From the Outlook 2002 Startup screen select Next. From the Account Configuration screen press Next. From the “E-Mail Accounts” dialog box, select the Server type (generally POP3) and press next. 5. From “E-Mail Accounts (Internet E-Mail Settings(POP3))”, enter the customers Name, E-mail address, Incoming/Outgoing Servers and the customers User Name and Password. Press “More Settings” and click on the Connection tab to select the connection type (i.e. Modem, LAN). Note: If selecting a Modem, you’ll need to add a Dial-Up Network Connection, press the Add button. From the “Phone book Wizard”, enter a name for the new Phone book (e.g. the ISP) and press Next. 6. Select “I am calling the Internet” and press Next. 7. Enter the Telephone number used to connect to the ISP and select Next. 8. Press OK to close the Internet E-Mail settings dialog box. 9. Press Next to continue. 10. Select Finish. With Outlook 2002, you’ll need to add the Personal Address book. 1. To add one go to Tools/E-mail accounts and click on Add a new Directory or Address book and press Next. 2. Click Additional Address books and press Next. 3. Highlight Personal Address book and press Next. 4. From the Personal Address book screen press Next. 6. Press OK and exit Outlook to activate the account. 7. Go to Tools/Address book. In the Show Names from the: field, drop down the list and select the Personal Address book. 8. Select Tools/Options and make sure that the Personal Address book appears in all 3 fields. If the PAB does not appear in When sending mail, check names using these Address lists in the following order, select Add, highlight PAB and press Add and then Close. Use the arrows to move the PAB to the top. 9. Press Apply, OK and close the address book. QUALITY SYSTEM DOCUMENT

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GE Medical Systems LUNAR

DOC ID: DXAP2030

REV: D

DATE: 3/1/02

CO: L10181

Section 4. SETTING UP WINFAX PRO SOFTWARE A. Configuring Windows NT to use the fax modem 1.

2.

3.

In Windows NT Control Panel, double click the “Modems” icon. Verify that in the list of modems there is an entry for “U.S. Robotics 56K Fax PCI” appears. If the “U.S. Robotics 56K Fax INT” entry does not appear, it must be added to NT. To add this modem to NT, check the Don’t Detect checkbox and then the Next button. Select Have Disk and insert the CD included with the modem. Change the drive letter to the root directory of the CD and continue. Select 3Com Corp. as the “Manufacturer” and U.S. Robotics 56k FAX INT as the “Model”, and select Next. When the Windows NT modem “Dialing Properties” dialog appears for the U.S. Robotics 56K FAX modem, complete the “Dialing Properties” dialog as appropriate for the customer’s site. Windows NT has on-line help available for this task. Don’t forget to connect the modem to the phone jack with a standard (RJ-11) phone cable.

H. Installing WinFax PRO 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12.

13. 14.

Insert the WinFax installation CD and wait for autorun to display WinFax Pro Menu Screen. Select Install. At the Welcome Screen, select Next. At the License Agreement Screen, select Yes. Select Next at the User Information Screen. Select Next at the Destination Folder Screen. The Default Setup Type is Typical, select Next. Select Next at the Select Program folder. Select Next at the Start Copying Files screen. At the File Copy Complete screen, select Next. Select Next at the WinFax Pro Setup (CSID) screen. (Leave the fields blank) At the “Modems and Other Fax Devices” screen, select the “56K FAX modem” from the modem and device list if it is not already selected and select Next. Select Next to Test the Modem. The results of the Test list the class and speed of the Modem. Select Next to continue.

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GE Medical Systems LUNAR

DOC ID: DXAP2030

REV: D

DATE: 3/1/02

CO: L10181

15. With “Yes” selected in the “Enable Controller” dialog box, select Next. 16. From the Configure E-Mail screen, select Next. 17. Select Cancel at the Online Registration screen and Yes to “Are You Sure?” select Next. 18. From the Ready to Configure System screen, select Finish. 19. Select NO to the Readme question. 20. Select Cancel the Live Update. 21. Select Yes to the Message Manager. 22. From the Phone book autolink screen, check Outlook 2000 and select OK. 23. Select Next at the Phone Book Name 24. Select the Set Information button. 25. Select the “Use Business Related Information” Radio button (if not already selected) and select OK. 26. Select Finish 27. After rebooting Windows NT and logging back on, verify that the fax icon appears on the status bar. 28. Close the Printers Dialog box and remove the CD. 29. Verify that you select WinFax as one of the available printers from within the application and that you can fax a patient report to Lunar service or some other destination.

Section 5. SETTING UP ADDITIONAL TELEDENSITOMETRY OPTIONS NOTE: There must be a functional network connection in order for the installation of Windows Networking to be tested. Consult with the customer’s IS department, or Network person, to determine the protocols and services required. If a workgroup (no server) is used then the specific TCP/IP address will have to be known before installing the NIC. If a DHCP Server is used, then a Computer Name and Domain must be known before installing the NIC. The Computer Name will have to be changed to match the one given by the Network Administrator. To change the Computer Name, Right click on Network Neighborhood from the Desktop. Go to Properties| Identification and Change. Edit the Computer Name and the Workgroup or Domain name. Reboot when prompted. DICOM and HL7 features require TCPIP protocol and default Windows Networking services to function properly. LUNAR factory PC’s will be setup to use a DHCP server. To change to a specific IP address: 1. Right click on the Network Neighborhood icon 2. Click on Properties 3. Click on Protocols 4. Click on TCP/IP Protocol 5. Make sure you are in the IP Address tab 6. Select the Specify an IP Address radio button QUALITY SYSTEM DOCUMENT

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GE Medical Systems LUNAR

DOC ID: DXAP2030

REV: D

DATE: 3/1/02

CO: L10181

7. Insert the correct IP address and subnet mask given by the IS support staff. 8. Click OK, Apply, OK and Restart to restart the system and complete the change to a specific IP address. A. Setting up AutoMentor Refer to the enCORE™ Operator’s Manual Outbox Options sections for more information. B. Setting up EMAIL Refer to the enCORE™ Operator’s Manual Outbox Options sections for more information. C. Setting up DICOM Refer to the DICOM Operator’s Manual for setup information. D. Setting up HL7 Refer to the LUNAR Ambassador HL7 Interface Configuration Manual for setup information. E. Setting up MULTI-USER DATABASE (MUDBA) When setting up the Multi-User Database, several issues will have to be considered. 1. Where will the database reside, on the Prodigy or DPX-NT PC or other peer-to-peer network or network server drive? 2. How will the site archive data? 3. Will the site share a printer? When sharing drives, make sure that you use the “New Share” option. Sharing the drives as “C$” can cause the sharing to be unsuccessful. These issues should be determined by the site who is also responsible for setting up the Multi-User Database on additional PCs. When installing enCORE™ software on other networked PCs, you can install the software in a workstation mode. Note: PC must be running a supported Operating System, either WinNT or WinXP. 1. Install the software from the CD using install option number 2. 2. Launch the enCORE™ software. 3. Disregard any errors about primary calibration files. 4. Go to Tools|User Options|Systems tab and check the Auxillary Workstation checkbox. Click OK to leave the User Options menu. 5. Close the enCORE™ application and relaunch it. 6. You will now be in the workstation mode. NOTE: you will not be able to perform patient measurements, QA’s or simulated measurements or simulated QA’s in the worksation mode. QUALITY SYSTEM DOCUMENT

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GE Medical Systems LUNAR

DOC ID: DXAP2030

REV: D

DATE: 3/1/02

CO: L10181

Refer to the document Setting Up a Multi-User Database for further instructions.

Section 6. Windows XP setup and configuration. All WinXP systems come with Modem and Networking factory installed and configured (Networking is setup as a Workgroup, see the site’s Network Administrator for Domain configuration). The computer name is ENCORE-XP. NOTE: There must be a functional network connection in order for the installation of Windows Networking to be tested. Consult with the customer’s IS department, or Network person, to determine the protocols and services required. If a workgroup (no server) is used then the specific TCP/IP address will have to be known before installing the NIC. If a DHCP Server is used, then a Computer Name will have to be changed to match the one given by the Network Administrator and the will have to be changed from a Workgroup to a Domain. • To change the Computer Name, go to Start/Control Panel/Network and Internet connections/Network connections. Drop down the Advanced menu and select Network Identification, Click the Change button. Change the name and reboot. • To set up the PC on a Domain, follow the same steps. • To change to a specific address, go to Start/Control Panel/Network and Internet connections/Network connections. Right click on the Local Area Network and select Properties. Double click on Internet Protocol (TCP/IP). Click the radio dial Use the following IP address and enter the correct IP address and subnet mask provided by the Network Administrator or the IS support staff.

Installing Outlook 2002 1 Insert the OL2002 CD in the CDD and wait for Autorun to launch 2. Enter the Product key (found on the back of the case), and press Next. 3. Accept the Agreement and press Next. 4. From the Type of Installation screen, change the path from C: to D: and click Next. 5. Begin the installation by clicking Install. 6. When the install is complete, press OK, reboot the system and remove the CD. New Outlook 2002 Setup Note: After setting up Outlook, the customer should be instructed to archive their mail on a weekly basis. This backup should place the archived file on the D: drive. In QUALITY SYSTEM DOCUMENT

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GE Medical Systems LUNAR

DOC ID: DXAP2030

REV: D

DATE: 3/1/02

CO: L10181

the event a customer uses the recovery image and they have not archived their mail to the D: drive, it will be lost including all contacts.

1. 2. 3. 4. 5.

6.

Double Click on the Outlook 2002 Icon. From the Outlook 2002 Startup screen select Next. From the Account Configuration screen press Next. From the “E-Mail Accounts” dialog box, select the Server type (generally POP3) and press next. From “E-Mail Accounts (Internet E-Mail Settings (POP3))”, enter the customers, • Name • E-mail address • Incoming/Outgoing Servers • The customers User Name and Password. • If the customer is connecting via modem, click on the More Settings button. • Click the Connections tab and click in the radio button by Connect using my phone line. • Under Modem click the Add button and with Dial-up to private network selected, press Next. • From the Phone Number to Dial screen enter the Telephone number used to connect to the ISP and select Next. • Enter a name for the connection (e.g. the ISP), and press Finish and then OK to close the Internet E-mail Settings dialog box. • Press Test Account Settings and enter your Internet User Name and Password. Check the box to Save this User Name and Password, click in the Me Only radio button and press Dial. You should connect to your ISP and all tests should complete with no errors. Click Close to exit the Test dialog and Next to continue. From the Congratulations screen press Finish. At this point you’ll be prompted to Activate your Outlook software. You can Activate it later but should be activated prior to using the e-mail feature in the encore software.

With Outlook 2002, you’ll need to add the Personal Address book. 1. To add one go to Tools/E-mail accounts and click on Add a new Directory or Address book and press Next. 2. Click Additional Address books and press Next. 3. Highlight Personal Address book and press Next. 4. From the Personal Address book screen, point the path for the address book to D: press OK. 10. Press OK and exit Outlook to activate the account. QUALITY SYSTEM DOCUMENT

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GE Medical Systems LUNAR

DOC ID: DXAP2030

REV: D

DATE: 3/1/02

CO: L10181

11. Start Outlook and go to Tools/Address book. 12. From the Address book, Select Tools/Options and make sure that the Personal Address book appears in all 3 fields. If the PAB does not appear in “When sending mail, check names using these Address lists in the following order”, select Add, highlight PAB and press Add and then Close. Use the arrows to move the PAB to the top. 13. Press Apply, OK and close the address book.

Archiving 1. 2.

First create a folder on the D: drive using Explorer, i.e. Outlook Archive From the main tool bar, click on Tools and select Options. From the Options page, click on the Other tab. Click on the AutoArchive… button. Click browse and point the path to the folder you just created.

Section 7. TROUBLESHOOTING CANNOT COMMUNICATE WITH THE NETWORK. If you cannot seem to communicate with the network, try the following: 1. Check the connection of the network cable into the network connector at the back of the computer. 2. Check to see if the lights next to the connector are illuminated. Both the send and receive lights should be illuminated. 3. If you are using a DHCP Client, make sure that DHCP is enabled. Refer to section D.3.ii. 4. Go to an MS DOS prompt from the desktop and ping the NIC (see example below). If this is successful then ping an address on the network. If this is not successful then you have a problem with the NIC or network setup on the PC. If you can ping the local PC but not the network then have the site contact there is staff to look into the problem further. i. Example: If you know the address of the network card type; ping 175.100.42.110 (example of a TCP/IP address) and press Enter. WINFAX IS INSTALLED BUT REPORTED NOT INSTALLED. After attempting to fax a report using WinFax, the system displays the error message “Printer driver is missing or the printer is not installed.” The cause of this problem is that Symantec’s installation program for WinFax does not update the Windows Registry correctly with any dependability. So even though WinFax is installed, the enCORE™ software cannot use WinFax on some installations because it cannot find WinFax’s default device mode settings. You can verify QUALITY SYSTEM DOCUMENT

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GE Medical Systems LUNAR

DOC ID: DXAP2030

REV: D

DATE: 3/1/02

CO: L10181

this is truly the cause of the problem by looking at the Windows Registry using the REGEDIT program. Confirm the absence of the Registry key named “DefaultDevMode” under the key named “HKEY_LOCAL_MACHINE\System\Current Control Set\Control\Print\Printers\WinFax”. PLEASE NOTE: incorrect use of the REGEDIT program can leave the PC inoperable! •

On the Windows ‘Start’ menu, select ‘Settings’ and then ‘Printers’. Then right-click on the ‘WinFax’ printer icon, and select ‘Document Defaults

•

Under the ‘WinFax Document Settings’ tree view, expand the ‘Paper/Output’ entry and select ‘Orientation’.

•

Change the ‘Orientation’ value from ‘Portrait’ to ‘Landscape’. Select ‘OK’.

•

Once again select WinFax’ ‘Document Defaults …’ dialog, and then select ‘Orientation’.

•

Change the ‘Orientation’ value from ‘Landscape’ to ‘Portrait’. Select ‘OK’.

•

There should now be a key in the Registry named HKEY_LOCAL_MACHINE\System\Current Control Set\Control\Print\Printers\WinFax\DefaultDevMode”.

•

Within Prodigy, you should be able to fax a report now.

GENERATED RECORDS None.

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g

MANUFACTURING PROCEDURES GE Medical Systems LUNAR

DOC. ID: DXPC2004 REVISION: G DATE: 12/06/02 WRITTEN BY: Jeff Salbego APPROVED ON CO: L10507

TITLE: enCORE PC Configuration Procedure /Win-XP

PURPOSE This procedure is used to setup a PC and software for Drive Imaging enCORE (aka Prodigy, DPX-NT, and DPX-MD+).

APPLICATION This procedure applies to all PC’s and software. Execute appropriate procedure steps based on the model of PC to be configured and the features requested by the sales order.

SAFETY PRECAUTIONS Disconnect the line cord from the Computer before opening the enclosure. Precautions should be taken (e.g. wearing of grounding straps, etc.), when necessary, to ensure a static-free environment exists when handling and installing PCB’s and other static sensitive devices.

ASSOCIATED MATERIALS DXPC2003 - Prodigy / DPX-NT PC Testing Procedure

MINIMUM HARDWARE SPECS • • • • • • • • • • •

900MHz Intel Celeron processor 512 MB RAM 20 GB hard drive 8 MB video RAM 52X CD ROM 250 MB Zip drive 56k Modem 10/100 MB network card Microsoft Windows XP Professional (SP1) 17” monitor Super VGA (1024 X 768) or higher resolution video adapter

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GE Medical Systems LUNAR

DOC ID: DXPC2004

REV: G

DATE: 12/6/02

CO: L10507

CURRENT SOFTWARE VERSIONS Operating System Emailing Software Faxing Software

Current Version

Notes

Microsoft WinXP w/ SP1 Refer to Section O Refer to Section P

*Only required for TeleD *Only required for TeleD

PROCEDURES

Section 1. SETTING UP THE PC (Standard configuration) Loading Application Software A.

Windows XP Professional Installation (not required for preloaded systems) Section A of this procedure is used to: 1) Setup the Disk for imaging or, 2) When replacing the system drive, only if attempts to recover a corrupt system have failed. The steps described here will erase all data on the system partition. The data will not be recoverable.

1. Restart the computer with the Windows XP Professional CD in the CDD. 2. When prompted to boot from CD, press . If you miss the prompt, reboot and start over. 3. Press at the Welcome to Setup screen. 4. Press to accept agreement and continue. 5. If a partition exists, use the up/down arrow keys to highlight it. 6. Press to delete the partition. Note: Deleting a partition will permanently destroy all data on the partition. Make sure any data has been backed up so that it can be later restored. This action is irreversible. 7. Press to continue deleting the system partition. 8. Press to verify deleting the partition. 9. If necessary, repeat the deletion of all existing partitions. 10. Press to create a new partition. 11. Use the Backspace key to clear the Default Partition size and enter 12500 as the partition size. Press to accept the partition size. 12. Cursor down to the unpartitioned space, press to create a second partition. Use the Backspace key to clear the Default Partition size and enter 20000 as the partition size. Press to accept the partition size and create the second partition. 13. Cursor down to the unpartitioned space, press to create a third partition. Press to accept the default size and create the third partition. The 3rd partition is where the recovery image will be stored and Must be formatted as FAT32. QUALITY SYSTEM DOCUMENT

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GE Medical Systems LUNAR

DOC ID: DXPC2004

REV: G

DATE: 12/6/02

CO: L10507

14. With drive highlighted, press to install the Partition. 15. Select the desired file system using up/down keys. Select “Formatting using NTFS File System” (the default) and press to continue. 16. Wait for partition to be formatted. 17. Wait for the file copy to complete. 18. Leave the CD in the CDD and press to restart the computer. Do NOT boot on the CD. 19. Once the system restarts it will proceed with installation. 20. Accept the defaults from the Regional & Language Options screen by pressing 21. Type in GE Medical Systems Lunar for both name and organization and press . 22. Type in the Product ID from the Certificate of Authenticity and press . 23. Type in ENCORE-XP for the Computer Name; do NOT enter a Password and press to continue. 24. Verify time and date; select the appropriate time zone, (Central Time(US and Canada) and press 25. From Networking Settings, accept the default (typical) and press 26. Press to setup the PC in a Workgroup called Workgroup. 27. When all the files have been copied, the system will reboot. Wait for it to restart and press to setup the computer. 28. When prompted to connect to the Internet press 29. Select to the Registration, and press 30. Enter in GE Lunar as name for the user and lunar (lower case) for the password and press 31. Press Finish/Next and the OS will boot. 32. Remove the CD 33. Click Start. Right click on My Computer and select Manage. Double click Storage and then Disk Management. 34. Right click on (G:) and select Change Drive Letter and Paths. Click the Change button and change the Drive Designation to (H:) temporarily. Confirm the change by pressing Yes. 35. Repeat the process till the letters are assigned as follows; 36. The Hard Drive (Disk 0) should be C: D: and G: 37. The Zip drive (Disk 1) should be E: 38. The CDD should be F: 39. Right click on the D: partition of disk 0 and select format. Enter “Applications” as the volume label and press OK to format the partition with the NTFS file system. 40. Right click on the G: partition of disk 0 and select format. Enter “Recovery” as the volume label, change the File System to FAT 32 and press OK to format the partition. 41. Open My Computer. Right click on C: and name the volume GE Lunar. 42. Close Computer Management. QUALITY SYSTEM DOCUMENT

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GE Medical Systems LUNAR

DOC ID: DXPC2004

REV: G

DATE: 12/6/02

CO: L10507

43.

Install XP-Professional Service Pack 1 found at netserver\R&D\software(32bit)\WinXP\SP 1 Note: If you’re installing other devices that need to copy files from the WinXP CD, install them prior to installing SP1.

B. Setting up the Network (Not necessary for Imaging purposes) 1. The Network is automatically setup (in a Workgroup) as the OS is installed. 2. To verify the connection, make sure the PC is connected to the Network and go to Start\Control Panel\Network and Internet Connections\Network Connections. 3. If the connection is disabled, double click on the Local Area Connection to Enable service. Click on My Network places. 4. Click on View workgroup computers and verify you can see other computers in the workgroup.

C. Configuring the Network for a Domain • Start\Control Panel\Network and Internet Connections\Network Connections. If the connection is disabled, double click on the Local Area Connection to Enable service. • Drop down the Advanced menu from the tool bar and select Network Identification. • Click the Change button. Under Member of, click in the Domain radio button. Enter Lunarcorp and press OK. Note: You will need a unique computer name and Administrator rights. • Enter User name and password and press OK. • When you’re welcomed to the domain, press OK and restart when prompted.

D. Video Driver Installation (not required for preloaded systems) All devices are detected and installed automatically by WinXP This is where new procedures for new devices/drivers will be added.

E. Internet Explorer Installation WinXP by default is bundled with I.E. version 6. Installation is not necessary at this time. This is where update/new procedures will be added.

F. Configure Desktop Settings (repeat for each user) 1. Right mouse click on an open space in the Task Bar and select Properties to configure Task Bar properties – Clear the Check mark from Keep the Taskbar on top of other Windows option. Remove the check mark from Hide inactive Icons, press Apply and OK. QUALITY SYSTEM DOCUMENT

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GE Medical Systems LUNAR

DOC ID: DXPC2004

REV: G

DATE: 12/6/02

CO: L10507

2. Right click in an open area of the Desktop and select Properties. Select the Desktop tab and set the Background to None. Click on Customize desktop. Remove the check mark from Run Desktop Cleanup Wizard every 60 days and press Apply 3. Click the Screen Saver tab, set the Screen Saver to None. Click the Power button and set all options under Power Schemes to Never. Press Apply and OK. 4. Click the Appearance tab and change the Windows and Buttons setting to Windows Classic and press Apply. 5. Click the Settings tab and set the Screen resolution to 1024x768 and color Quality =Highest (32bit) If no changes were necessary, proceed to step # 6 6. Press Yes and OK to set the selections and exit the display setup. 7. Go to Start\Control Panel. Click on Date, Time, Language and Regional Options. Click on Regional and Language Options. Click the Customize button and then select the Date tab. Set the short date format to mm/dd/yyyy. Click Apply and OK, OK. 8. Click on Date and Time. Select the Internet Time tab and remove the check from Automatically synchronize with an Internet time server. Press Apply and OK. 9. Click the Back ← and open Performance and Maintenance. Click on the System Icon. 10. Click on the Advanced tab and then Error Reporting. Click in the Disable error reporting radio dial. Press OK. Click Settings from the Performance box and then select the Advanced tab. Click Change in the Virtual Memory box and change the Paging File size of drive “C” in both the Initial size and the Max size to 1000. Click Set, OK, OK. Reset when prompted. 11. Click on the System Restore tab and check the box for Turn of System Restore for all drives. Press Apply and a message pops up asking if you really want to stop System Restore. Press Yes. 12 Click on the Automatic Updates tab. Click in the Turn off automatic updating radio button. Press Apply and close everything up. 13.Press Start, Right click on My Computer and select Manage. Expand Services and Applications. Click on Services to disable the following service. Double click on Web Client. Stop the Service and set the Startup Type to Disabled. Press Apply and OK. 14. Open Device Manager and expand USB Controllers. Right click on the first USB Root Hub and select Properties. Open the Power Management tab and de-select the Power Save option. Press OK and close the Computer Management screen. 15. Close the Computer Management window. 16. Press Start, All Programs and select Windows Messenger. Cancel the .Net Passport Service setup. From the Windows Messenger dialog box, drop down the Tools menu and select Options. Click the Preferences tab and remove the check mark from both “Run this program when Windows starts” and “Allow this program to run in the background”. Press OK.

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GE Medical Systems LUNAR

DOC ID: DXPC2004

REV: G

DATE: 12/6/02

CO: L10507

G. Install MultiLingual User Interface (MUI) Subject to change 1. Insert the CD label Disk 1 2. At the Welcome screen, Accept the License Agreement and press Continue. 3. Check all languages in the Install Languages for menus and dialogs screen and press OK. 4. Insert the Windows XP CD when prompted and click OK. 5. Wait for the files to copy and insert the MUI CD disk 1 and press Yes when prompted. 6. When the fonts are installed press OK, and reboot when prompted. 7. Repeat the process with all MUI Disks. Disks 3 and 4 do not auto run

H. Install (PCI) Modem Card and Drivers (Installed on all PC’s) With the PC shut off, unplugged and grounded, insert the Modem (supplied from OTC) in the 3rd PCI slot. Startup the PC and from the New Hardware Wizard, select install from a list or specific location (Advanced) and press Next Select Search removable media, insert the OmniTech Technical Data CD (v1.81 or higher) and press Next. The Wizard will find the driver and install it. Open the control panel, select printers and other hardware then Phone and Modem options. From the Modem Setup screen, enter 608 for the area code and press To test the Modem, use Dialer found in the WinNT folder. Open Dialer and drop down the Phone menu from the tool bar and select Dial. Enter the number to connect to, click in the Phone call radio button and press Place Call. Press Disconnect and close the Phone dialer.

I. SeaCOM Serial Adapter Hardware Installation (PRODIGY ONLY) Check Jumper settings on board: J1A = On for P,P,T and off for L, L J1B = All jumpers off J1C = DIV2 on and off for DIV1 and DIV4 1. Copy files to the HDD and Setup prep. • Using Explorer, create a folder on the D: drive Program Files. Create a folder in this folder called SeaCOM. • Copy the SeaCOM drivers into this folder. • Use Explorer to run the Setup program from the SeaCOM folder on Drive D: • From the Welcome screen, press Next. • Accept the agreement by pressing Yes. QUALITY SYSTEM DOCUMENT

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GE Medical Systems LUNAR

DOC ID: DXPC2004

REV: G

DATE: 12/6/02

CO: L10507

• • • • • • • •

Press Next at the Customer Information screen. Accept the default Destination Location by pressing Next. Accept the default Setup Type (Typical) by pressing Next. Accept the default Program Folder by pressing Next. Un Check Launch Help File and press Finish. Shut down computer using “Start|Turn off Computer”. Unplug the PC and Remove the cover. Remove blank panel from PCI slot 2 to make room for SeaCOM serial card. Note: Slots are numbered from the inside to the outside with the inside slot being number one. • Install the SeaCOM PCI card into slot 2. Secure the card into slot using the screw removed from blank panel. • Insert power cord and turn power on. • After the system boots, it will detect the card and the New Hardware Wizard will start.

2. Installing the Drivers • Press Next at the New Hardware Wizard. • Press Continue Anyway from the Compatibility Warning. • Press finish to close the Wizard. • The New Hardware Wizard will start up again, press Next. • Press Continue Anyway from the Compatibility Warning. • Press finish to close the Wizard. • To Test the card, follow the steps at the end of step L. Note: All PC’s from OTC come with a modem. The SeaCOM card will be configured as COM4.

J. Creating the Recovery Image Prior to creating the “Recovery “ image (this is an image of the operating system setup prior to Lunar Application software installation) verify/perform the following1. Empty the Recycle Bin. 2. Verify there is no errors from the last boot in the Event viewer. Start, Right click on My Computer and select Manage. Expand Event viewer and check and clear all events from both Application and System. 3. Disable “Autoplay” for the Zip drive by installing TweakUI. Found at (\\netserver\R&D\Software (32bit)\WinXP) or see the PC setup department. Run Setup. Go with the defaults except, select Custom install and install only the TweakUI component. QUALITY SYSTEM DOCUMENT

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GE Medical Systems LUNAR

DOC ID: DXPC2004

REV: G

DATE: 12/6/02

CO: L10507

4. From the Programs menu, run TweakUI. Expand My Computer. Expand AutoPlay. Click on Types and disable AutoPlay for Removable drives. 5. Install Acrobat Reader. • Insert the enCORE CD and exit the browser • Use Explorer to run Setup from the Acrobat folder. • Click Next at the Welcome screen. • Click Next at the Destination Location screen. • Press OK to finish. 6. Remove TweakUI 7. Refer to LUPC0006 to create the Image. Make the Recovery image and copy it to G: 8. All OmniTech PC models with on board LAN have networking installed. If the system is not connected to the Network you’ll see a red X through 2 PC’s, which means the Network cable is unplugged. To stop this from being shown on the Task bar, click the red X. Right click on the Local Area Connection and Disable it.

K.

Printer Setup: HP940c • Setup the printer (with cartridges and paper), and turn it on. Connect it to the PC and the basic 940c print drivers that come with XP will be installed. • Open the Control Panel/Printers folder, right click on the printer and select Properties. • Install the Enhanced driver from HP.In the Advanced tab click on New Driver. Click Next and then Have Disk. • Point the installation to the enCORE cd. Path = Printer\WinXP\hp940c\enu\driversWin2k_XP • Select the .INF file and click open. Click Ok to continue • Click Next, Finish and then Ok • Open the Printers folder (if necessary) and Delete the newly installed printer. • Restart the PC and after logging in the printer will be detected. Point the installation to the same path as in the step above and complete the installation. Subsequent installations of the 940c printer will install the enhanced driver. (note: delete the printer prior to creating the image) • For USB printers turn off Power Management HP Business Inkjet 2280 Note: The very first time the printer is turned on it can take up to 15 minutes to initialize and warm up. Also when an ink cartridge is changed it can take a while to prime. • Connect the printer to the PC and cancel the new Hardware Wizard. • Insert the HP Printer Driver CD • Select Install Printer Driver • Press OK to install the software in English

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GE Medical Systems LUNAR

DOC ID: DXPC2004

REV: G

DATE: 12/6/02

CO: L10507

•

Press Next at the Welcome screen and Accept the License Agreement • With “Connect directly to this computer” selected, press Next • With Parallel selected and LPT1 highlighted, press Next • Select Custom setup and press Next • From the Components dialog box, deselect the HP Business Inkjet 2280 PCL 5C driver and press Next • Press Install from the Installation Settings dialog box • At the start of the installation you’ll receive a message stating that Microsoft has not tested the driver. Press Continue Anyway • Form the Setup Complete window deselect Register Printer and press Finish. Exit the HP Installer by pressing Exit twice. • Set the printer as the default printer and Print a test page by going to the properties page of the printer by selecting Start/Faxes and Printers and right clicking on the printer. HP 5550 • Connect the printer and from the New Hardware Wizard, select install from a list or specific location (Advanced) and press Next • Select Search removable media, insert the HP CD and press Next. • From the list of drivers, click on \enu\drivers\Win2k_xp\hpf5550k.inf and press Next. • Print a test page. • Exit the installation and close the New hardware wizard by pressing Finish.

L. Application Software Installation (Not installed on the recovery CD) 1. Obtain the latest Production Master Application Software CD and insert it in the CDROM drive. 2. Wait for autorun to display Lunar CD Browser menu. 3. Select product installation from Lunar CD Browser menu. 4. Press Yes to accept the EnCore Software License Agreement. 5. The Default is Install required components. Accept this and press Next to continue. 6. The installation is in several parts. Restart the system (if prompted) after each component is installed. 7. Press at the Product Welcome screen. 8. Press at Information screen. 9. Press at the User Information Screen. 10. Press at Install Location screen. (accept default location). 11. Press Next to continue. 12. Leave the System# and Feature Code fields blank and press to continue. 13. Press to “Start Copying Files” 14. Press to “Start Copying Files” QUALITY SYSTEM DOCUMENT

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GE Medical Systems LUNAR

DOC ID: DXPC2004

REV: G

DATE: 12/6/02

CO: L10507

15. Select Yes “I want to Launch Prodigy/DPX-NT (or MD+)” now and Press Finish. As the Software opens, you will receive a few dialog boxes. (The SeaLevel COM Port will be Auto detected.) • If Tele-D is enabled in the feature code and Outlook is not yet configured, you will be prompted with an error message from Outlook stating there is no default mail client followed by an application error message stating, “Enhanced messaging API is not available. These message boxes will appear on application startup until Outlook is properly configured. • Click OK to create a New QA Database • Click OK at “ No Primary Calibration file is specified” (Prodigy only) • Click OK at “ No Database Connections” • Set the archive path to the appropriate drive letter, if not A: and set the database path to D: Click OK to accept the New Database. • Remove the CD and test the SeaLevel card. Connect the PC to Test box 1 located in the PC setup room. From the main menu, select Tools/User Options. Click in the Service Check box and enter Award (Case Sensitive) as the password. Click OK twice. • Select Tools/Service Options. Click on the Serial tab and press Test Communications. The only test that should timeout (Prodigy only) is the detector test (Waiting for ABT-TIMEOUT), all other tests should return with OK. Exit the Software only. Do not shut down the PC at this time.

M. NIC Installation. (Network Interface Card) Note: Omni Tech PC Models # OEM-1000D01810E, 8100D05815 and the OEM-3124D00 Halyron ESG come with integrated Networking. Startup the PC and from the New Hardware Wizard, select install from a list or specific location (Advanced) and press Next Select Search removable media, insert the OmniTech Technical Data CD (v1.81 or higher) and press Next. The Wizard will find the driver and install it. Re-install Service Pack 1

N. Zip Drive Installation Hardware - Refer to LUPC0001 (Verify latest Rev) for the drive installation procedure. Software - All devices are detected and installed automatically by WinXP Drivers are not necessary but can be installed from Iomega’s website or PC Production

O.

Installing Outlook 2002

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GE Medical Systems LUNAR

DOC ID: DXPC2004

REV: G

DATE: 12/6/02

CO: L10507

1. 2.

Insert the CD and wait for Autorun to launch. Enter the Product key (found on the back of the case), and press Next. 3. Accept the Agreement and press Next. 4. From the Type of Installation screen, click Next. 5. Begin the installation by clicking Install. 6. When the install is complete, press OK, remove the CD and reboot the system. 7. After the system boots, insert the CD when prompted and press OK. Refer to DXAP2030 for Setup/Testing Procedures. For in-house testing purposes, Webserver must be turned on (see IT admin) • Use rdtest1 for the user name and password. (both lower case) • Incoming and outgoing servers are Webserver. • E-mail address is [email protected]

P.

Installing the WinXP Fax Component 1. Click Start\Printers and Faxes. 2. Click on Set up Faxing 3. When prompted for the WinXP CD, insert the OmniTech Recovery CD (Packaged with each system). Click OK. 4. Click on browse and point the installation to the I386 folder on the CD. 5. Press Ok twice and wait for the installation to finish. 6. From Printers and Faxes, click on Install a local Fax Printer. 7. Close up Faxes and Printers. 8. Install SP1 •

Configuring AutoMentor 1. Subject to change.) Verify that you select WinFax as one of the available printers from within the application and that you can fax a patient report to Lunar service or some other destination. AutoMentor is not enabled at this time.

Default Boot Sequence • FDD • CD-ROM • HDD

Q.

PCI card slot assignment • • •

The 1st blank panel is for the 2nd serial port PCI Slot 1: Adaptec SCSI Card (Optional) PCI Slot 2: SeaLevel Serial Card

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GE Medical Systems LUNAR •

R.

DOC ID: DXPC2004

REV: G

DATE: 12/6/02

CO: L10507

PCI Slot 3: Modem

Creating the Image

Prior to creating the Final image (this is the image of the operating system setup with the Lunar Application software installed) verify/perform the following1. Empty the Recycle Bin. 2. Verify there are no errors from the last boot in the Event viewer (Start, Programs, Administrative Tools, Event viewer) 3. Analyze/Defrag the HD (both drives) by going to Start, All Programs, Accessories, System Tools, Disk Defragmenter. Run Analyze to see if Defrag is necessary. Note: All OmniTech PC models with on board LAN have networking installed. If the system is not connected to the Network you’ll see a red X through 2 PC’s, which means the Network cable is unplugged. To stop this from being shown on the Task bar, click the red X. Right click on the Local Area Connection and Disable it. Note: Prior to connecting a system to a LAN, the Connection must be re-enabled. 4. Refer to LUPC0006 to create the Image.

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GE Medical Systems LUNAR

DOC ID: DXPC2004

REV: G

DATE: 12/6/02

CO: L10507

Section 2. Duplicating Product Software If the appropriate version of software is already loaded on the local hard disk, proceed with Step B. This can be verified by locating the appropriate folder named \product_X_XX_XXX on local hard drive; where product_X_XX_XXX is the product software version to be duplicated. Note: For Adaptec’s Easy CD creator instructions, refer to DXPC2000. A.

Creating Master Software on Duplicator PC. • • • • • • • • • • • •

B.

Insert product “Master Setup CD” into CD-ROM drive. Wait for Lunar CD Browser to start. Exit Lunar CD Browser. Create folder named \product_X_XX_XXX on local hard drive. Copy entire contents of product “Master Setup CD” into folder created above. Wait for copy to complete and remove the “Master Setup CD” from the CD-ROM drive. Start NERO burning software. Press the New button. Select entire contents of the folder product_X_XX_XXX. Drag and Drop the selected files and sub-folders to the CD layout. Select File/Compilation Info, click the Label tab and name the Volume to match the version of software. Select File/Save.

Create Product CD. • • • • • • • • • •

Insert blank CD into CD-ROM drive. Start NERO burning software. Press the New button. Select entire contents of the folder product_X_XX_XXX. Drag and Drop the selected files and sub-folders to the CD layout. Click File/Write CD and then click on Write. Press OK at the Compilation created successfully dialog. Press Discard and remove the CD. Validate CD layout using menu. Apply label “Disk 1 of 2 Insert Disk, wait for AutoStart, follow directions” to

•

Application CD Apply label “Mulit-Media Disk, Disk 2 of 2” to Multi-Media CD

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GE Medical Systems LUNAR

DOC ID: DXPC2004

REV: G

DATE: 12/6/02

CO: L10507

Section 3. Configuring Application Software • • • • •

Check Sales Order for System Number and Application Sites. Get S/W Order Form FM03-4. Start Configurator. Enter System Number and select the options per the sales order. Do not enable any application that does not have okay to ship status unless approved by Regulatory Affairs. Review table below for latest status. If Regulatory Affairs approval is granted, then enable the application and add special “Investigation” label on software.

Application

DPX-MD+ Release Status

DPX-NT Release Status

Prodigy Pro Release Status

AP Spine Femur Total Body

Standard Standard Optional (Full-size Only) Optional Optional

Standard Standard Optional (Full-size Only) Optional Optional

Optional

Dual Femur Advanced Hip Assessment Pediatric Spine Pediatric Total Body Forearm oneVision Orthopedic Lateral HL7 Multiuser DB Teledensitom etry Dicom Lateral View Business Reports (encore composer)

Standard Standard Optional (Full-size Only) Standard Optional

Prodigy Oracle Release Status Standard Standard Standard (Full-size Only) Standard Optional

Prodigy Vision Release Status Standard Standard Standard (Full-size Only) Standard Standard

Optional

Optional

Optional

Optional

Optional

Optional

Optional

Optional

Optional

Optional Optional Optional Optional Optional Optional Optional

Optional Optional Optional Optional Optional Optional Optional

Optional Optional Optional Optional Optional Optional Optional

Optional Optional Optional Standard Optional Optional Optional

Standard Standard Optional Standard Optional Optional Standard

Optional Not Available Optional

Optional Not Available Optional

Optional Optional Optional

Optional Standard Standard

Standard Standard Standard

QUALITY SYSTEM DOCUMENT

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GE Medical Systems LUNAR

DOC ID: DXPC2004

REV: G

DATE: 12/6/02

CO: L10507

Physician Reports (encore composer) Animal body

Optional

Optional

Optional

Standard

Standard

Not Available

Not Available

CAD

Optional

Optional

Optional. Need warning label 40122 Optional

Optional. Need warning label 40122 Optional

Optional. Need warning label 40122 Optional

OneScan Hand APVA Absolute Fracture Risk All other Software Options

Optional Not Available Not Available IRB Only

Optional Not Available Not Available IRB Only

Optional Optional IRB Only IRB Only

Optional Optional IRB Only IRB Only

Optional Optional IRB Only IRB Only

Internal use only

Internal use only

Internal use only

Internal use only

Internal use only

Note: Compact systems do not require a configuration feature code. They are configured in the field at the time of install using Service Options. Serial and System numbers: DPX-NT (DPX-MD+) NTA Beta NTA Production NTB Beta NTB Production NTC Beta NTC Production

First Scanner Number

First System Number

70001 70101 72001 72101 73001 73101

NT+70000 NT+70000 NT+72000 NT+72100 NT+73000 NT+73100

DPX-NT 180 (DPX-MD+ 180) NTB-180 Beta NTB-180 Production NTC-180 Beta NTC-180 Production

90001

NT-90101

91001 91101

NT-91000 NT-91100

Prodigy Prodigy 1 Beta Prodigy 1 Production Prodigy 2 Beta Prodigy 2 Production Prodigy 3 Beta Prodigy 3 Production

60001 60101 62001 62101 63001 63101

DF+10001 DF+10001 DF+12000 DF+12100 DF+13001 DF+13101

QUALITY SYSTEM DOCUMENT

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GE Medical Systems LUNAR

DOC ID: DXPC2004

REV: G

DATE: 12/6/02

CO: L10507

Prodigy 4 Beta Prodigy 4 Production

64001 64101

DF+14001 DF+14101

Prodigy Compact Prodigy 3 Compact Beta Prodigy 3 Compact Production Prodigy 4 Compact Beta Prodigy 4 Compact Production

80001 80101 81001 81101

DF-80001 DF-80101 DF-81001 DF-81101

Note, in each system number, the plus or minus symbol is used to denote total body option availability. This has been for historical purposes. Configurator is not conditionally tied to this convention. Application Production Release Limited release for user tests at early adopter sites • • • • • •

DPX-MD+ Release Status 6.70.021 on NT hardware

DPX-NT Release Status 6.70.021

Prodigy Release Status 6.70.021

7.00.286

7.00.286

7.00.286

Configurator program automatically generates the feature code. Select required printer, using menu command “File|Printer Setup”, to Epson FX-880. Print three labels. Remove labels and place one on the S/W Production Form in the designated area. Place the second label on the CD Diskette sleeve. Place the third label on the PC Form. Using Copy/Paste (Ctrl C/Ctrl V), take feature code from configuration and paste into Filemaker DB program. Fill out paperwork associated with software order form.

Note: Internal QA/Production software should be configured as System Number 00002 with all sites enabled.

GENERATED RECORDS DXPC2001 FM03-4

DPX Fan PC Configuration Form Software Order Form

QUALITY SYSTEM DOCUMENT

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g

MANUFACTURING PROCEDURES GE Medical Systems LUNAR

DOC. ID: DXAP3031 REVISION: A DATE: 12/27/01 WRITTEN BY: Mike Buchholz APPROVED ON CO: L10122

TITLE: 230V Small Room Kit Installation Instructions

PURPOSE This procedure describes the steps necessary to install the 230V small room kit (including isolation transformer) at a customer's site. The isolation transformer reduces leakage currents from the computer and peripherals.

APPLICATION This procedure applies to all employees performing installation of a DPX-NT or Prodigy system. The small room kit is used whenever metal surfaces of the computer or peripherals are within 1.83 meters of the scan table (inside the patient environment).

SAFETY PRECAUTIONS Verify that power is not applied to the transformer when changing or checking the fuses.

ASSOCIATED MATERIALS None.

DEFINITIONS None.

PROCEDURES 1.

VERIFY PROPER INPUT VOLTAGE A. Measure the voltage at the wall outlet (or UPS if applicable). If the voltage is less than 180VAC, this transformer (LU8747) may not be used. If the voltage is 180VAC or more, proceed to step 2.

QUALITY SYSTEM DOCUMENT

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GE Medical Systems LUNAR 2.

DOC ID: DXAP3031

REV: A

DATE: 12/27/01

CO: L10122

CONNECTING TRANSFORMER A. Remove the label which covers the transformer input and discard it. If a UPS is being used, power the transformer and scanner from the UPS. Do not power the UPS or scanner from the transformer. This may overload the transformer. B. The transformer may be placed on the floor, but it is best to place it on the computer cart. It should be placed such that its metal enclosure cannot easily come into contact with other equipment. C. Verify that all peripherals have inputs which are suitable for voltages greater than 180VAC. Some peripherals may require that an input switch be appropriately set. D. Attach all peripheral inputs to the transformer outputs using the cords provided. If an outlet strip was provided with the computer, discard it. E. Power-up all peripherals and verify proper operation.

3.

REPLACING FUSES A. If no peripherals will power-up, it is likely that a fuse is blown. To replace the fuses, follow the steps below. B. Unplug any cords from the transformer input. Using a standard screwdriver, open the fuse lid and remove the fuse carriage. See Figures 1 and 2.

QUALITY SYSTEM DOCUMENT

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GE Medical Systems LUNAR

DOC ID: DXAP3031

REV: A

DATE: 12/27/01

CO: L10122

Figure 1 Opening the fuse lid.

QUALITY SYSTEM DOCUMENT

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GE Medical Systems LUNAR

DOC ID: DXAP3031

REV: A

DATE: 12/27/01

CO: L10122

Figure 2 Removing the fuse carriage.

QUALITY SYSTEM DOCUMENT

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GE Medical Systems LUNAR

DOC ID: DXAP3031

REV: A

DATE: 12/27/01

CO: L10122

C. Replace the two fuses in the carriage with the spares taped to the transformer. See Figure 3 for correct installation. See Figure 4 for incorrect installation.

Figure 3 Correct fuse installation.

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GE Medical Systems LUNAR

DOC ID: DXAP3031

REV: A

DATE: 12/27/01

CO: L10122

Figure 4 Fuse has slid out of holder. Reposition and try again. See Figure 3. .

GENERATED RECORDS None.

QUALITY SYSTEM DOCUMENT

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6 1 Maintenance Chapter 1:Maintenance

This chapter contains brief discussions of the Preventative Maintenance procedure and Check Sheet as well as a discussion on unusual sounds and a listing of change orders associated with the Prodigy scanner. 6.0 Preventative Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-169 6.1 Unusual Sounds . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-170 6.0.1 QA History. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-169 6.0.2 Repacking the High Voltage Cable Connectors . 6-169 6.0.3 Wear . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-169 6.0.4 Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-169 6.0.5 Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-169 6.0.6 Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-170 6.2 Change Orders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-170

PRODIGY Service Manual (Rev B - 1998)

Maintenance6167

This page left blank intentionally.

6-168Maintenance

PRODIGY Service Manual (Rev B - 1998)

6.0

Preventative Maintenance • There are a number of items to be checked, cleaned and tested during a PM visit to a site. See the Prodigy PM / Service Call Checklist in Appendix 6-A.

6.0.1QA History An important aspect of the PM is checking the QA History (see section ). This is important because when a QA is run during the PM, it should be consistent with the past QA's. Copy the QA history file to a diskette and send to the LUNAR Customer Service Department.

6.0.2Repacking the High Voltage Cable Connectors The major work of a PM is the repacking of the High Voltage Cable connectors. See procedure DXSE0000 in the chapter 5 Appenices. It is VERY IMPORTANT that this procedure be understood completely before performing it!

6.0.3Wear The scanner should also be checked for signs of wear. The Shutter Assembly especially should be inspected. Wear on these parts can cause lead shavings to fall on the filter in the x-ray beam. This can cause a drastic decline in Reference Counts, causing QA's to fail. Also check all the scanner's moving parts for signs of wear. • This would include wheels, pulleys, gears, bearings, belts, cables and motor assemblies. • INSPECT CAREFULLY cables that enter the plastic cable track. These cables are subjected to a good deal of motion and thus have the potential for breakage! • Also, when performing the various tests listed below, listen for any unusual noises that could be indications of wear.

6.0.4 Cleaning Cleaning the scanner is important. • Remove dust and any debris from the electronics mounting chassis. • Clean the transverse and longitudinal extrusions. Small bits of debris from the wheels may accumulate and impede motion. • Clean the Shutter Assembly and the filter, if necessary (see 6.0.3).

6.0.5 Inspection

PRODIGY Service Manual (Rev B - 1998)

Maintenance 6-169

• Inspect the scanner internally and externally for obvious damage and loose connections. • Check all PCB's for tight mounting screws.

6.0.6Tests Run all other tests according to the Prodigy PM check sheet.

6.1

Unusual Sounds A high pitched sound is normally heard when the scanner is in motion. This is caused by the high frequency motor pulses being sent from the Centent Motor Controller to the Transverse and Longitudinal Motors. If the high pitched sound only occurs during motor operation, check the optical interrupt disks and verify that they are not rubbing against the black plastic transducer of the OMI board (see section 5.x). The disk should turn in the middle of the transducer's slot. For other sounds of an apparent mechanical nature, check all appropriate gears and pulleys. Verify that the set screws are tightened and that the gears and pulleys are not out of position. With the scanner turned off, move the affected parts by hand to determine the exact source of the sound. Also look for rusted or worn bearings and examine the V-wheels for wear. With age, the longitudinal and transverse drive belts will dry out and start to cause noises. Treating these belts with belt dressing is a short term solution until they can be replaced. Clicking or clunking sounds made during motor operation can be caused by belts that are riding up on their pulleys, or by a too tight bearing support. The bearing support is held to the carriage by a set screw from the rear. If this set screw is so tight that the bearing and support have no play (i.e. can be rocked 1-2 mm), it can cause a clunking sound during transverse motion. If this screw is loosened, it should be secured with Lock-Tite so it cannot work its way loose. Pulleys that have become defective can also cause clicking and squeaking/ squealing sounds. Try to isolate the movement of individual pulleys to locate the defective part. Scraping sounds can be caused by any of the moving carriages, cables or cable track rubbing against an adjacent panel. Localize the sound and investigate the appropriate areas.

6.2

Change Orders As engineering changes are made to the Prodigy Scanner, they will be noted herein future revisions of this manual.

6-170Maintenance

PRODIGY Service Manual (Rev B - 1998)

g

DOC. ID: DXSE0012 MANUFACTURING PROCEDURES GE Medical Systems LUNAR

REVISION: G DATE: 2/28/02 WRITTEN BY: Jeff Franz APPROVED ON CO: L10173

TITLE: DEXA PM Work Instructions

PURPOSE This procedure describes the steps necessary to do a Planned Maintenance Check on a DEXA scanning system at a customer's site, and to assure that the system is operating within GE-LUNAR's specifications and in compliance with applicable Federal and State regulations.

APPLICATION This procedure applies to all employees performing Planned Maintenance or Site Certification of DPX Series or PRODIGY, and DPX-NT scanning systems.

SAFETY PRECAUTIONS When power is applied this equipment generates ionizing radiation. Take precautions that no part of your body passes through the x-ray beam when the equipment is energized.

ASSOCIATED MATERIALS DXAP0008 DXAP2007 DXAP3002 DXQC0022 DXQC2022 DXSE0036 DXSE0038

DPX-Series Installation Test Procedures Prodigy Hacksaw Test DPX-NT Installation Test Procedures Aluminum Spine Phantom Scan Procedure enCORE software Aluminum Spine Phantom Scan Procedure OINK Daughter board and Limit Switch Field Replacement Instructions DEXA PM Quality record

DEFINITIONS DPX Series scanners are all non- Prodigy, non- DPX-NT/MD+ scanners. enCORE based systems are all PRODIGY and DPX-NT/MD+ scanners. PRODIGY I systems are defined as PRODIGY systems with system numbers 11999 and lower. DPX-NT (A) systems are defined as DPX NT systems with system numbers 71999 and lower. QUALITY SYSTEM DOCUMENT

Page 1 of 10

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GE Medical Systems LUNAR

DOC ID: DXSE0012

REV: G

DATE: 2/28/02

CO: L10173

PROCEDURE A. QA HISTORY AND ERRORLOG. 1. Perform a Quality Assurance test to insure the system is operating. a. Verify that all tests on the QA are passing. 2. DPX Series scanners: The QA values needed may be found by viewing the QA database (F4 Database options – F2 QA History) and / or in the Daily QA printouts in the Customer’s QA binder. a. Verify that the Detector has not lost significant resolution by checking that the high and low energy air counts have not decreased by more than 10% from the date of installation or the date of the last tube head or detector change). b. Verify that the air ratio has not changed by more than .02. from the date of installation or last tube head or detector change (calculate from earliest QA or lookup on QA printouts). 3. Systems with enCORE software a. Copy the QA.mdb file to a diskette (Tools / Send Configuration / Select Error Log and QA Database, make sure compress Files is selected and select Span Multiple Disks if necessary). b. Select the appropriate drive (3 ½ floppy A: ) insert disk into drive and click OK. c. Label with system number and PM, the file may be mailed to Service Engineering or email file to [email protected] NOTE: This is only to gather statistical information on enCORE based systems performance, there will be no follow up regarding these QA histories. 4. Analysis of the QA History file a. DPX Series i. Verify % Spillover is between 6.3 and 9.5 ii. Check the Air Ratio – it cannot deviate more than .02 since the last detector / tube change iii. Check the low air counts – a change greater than 10% since the date of last detector change indicates a failing detector iv. Check the Large standard Mass – should not deviate more than 2%

QUALITY SYSTEM DOCUMENT

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GE Medical Systems LUNAR

DOC ID: DXSE0012

REV: G

DATE: 2/28/02

CO: L10173

v. If any of the above parameters are failing, call GE-Lunar Customer Support for help diagnosing the system. 1. To aid in diagnosis, email the QA.MDB file to [email protected] 5. Review the error log(s). b. DPX Series systems print from DOS prompt i. C:\> ERRDUMP –L –N >PRN

c. d. e.

f. g.

1. See DPX Series CSB Vol 9 for DPX Series Error Log Interpretation enCORE based systems Tools\ Error Log – add to instructions Verify that there are no hardware subsystem failures (X-ray, Detector, Mechanical) Contact Lunar Service Department if any unexplained or unusual errors are discovered in the error log. i. Error Log may be faxed to 608-826-7107 to aid in interpretation. Delete error log for DPX Series (C:\LUNAR> del err_320.bin or C:\LUNAR del errlog.bin). Start a new error log for enCORE-based systems by clicking on Initialize Log.

B. HOST PC MAINTENANCE 1. Clean the Printer according to the manufacturer’s instructions a. For Hewlett Packard Printers go to www.hp.com and search the support pages for the customer’s printer model. 2. DPX series systems: a. From a DOS prompt i. Delete contents of C:\SCRATCH and C:\PRNTMNGR directories. ii. Delete all *.CHK files in C:\ directory. 3. Software updates a. DPX Series systems: all DPX-IQ densitometers may be updated to version 4.7e software free of charge. b. All other (non-IQ) DPX Series Densitometers should be running version 3.65 or 4.7e (if upgraded to IQ software) c. If the customer is running a version lower than 4.7e, or 3.65 ask them if they are interested in this free update, they may get by contacting the GELunar Apps line (USA) or you may order it from GE-Lunar at [email protected] or at 866-225-4771. QUALITY SYSTEM DOCUMENT

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GE Medical Systems LUNAR

DOC ID: DXSE0012

REV: G

DATE: 2/28/02

CO: L10173

d. enCORE based systems: i. Contract and Warranty customers are entitled to free software updates (all software versions 6.0 is considered an upgrade and all customers must purchase it) ii. Billable customers may purchase software updates by contacting GE-Lunar at 866-225-4771.

C. SCAN TABLE MAINTENANCE 1. Remove the scanner tabletop. a. Power down the scan table. b. DPX Series tables – unlock the end panel doors and remove the tabletop screws. i. DPX-IQ ii. Non DPX-IQ c. DPX-NT – unlock the end panels and remove the tabletop screws. i. d. PRODIGY – lift up the table pad and remove the 4 counter sunk 1/8” hex head screws in the 4 corners of the tabletop. 2. Clean the scanner interior a. Clean the electronics pan of dust and dirt. b. Wipe the dust and dirt off of the rear longitudinal rail and the transverse rail. 3. Inspect mechanical parts and cables for wear and breakage. a. Check all cables on the cable trough for wear b. Check the v-wheels on the rear longitudinal carriage for appropriate tension Insert V-wheel instructions. 4. X-Ray Generator a. Power up the scan table. b. Ramp the scanner to the appropriate kV / mA and read the test points on the appropriate board as indicated in the X-Ray Settings table on DXSE0038. i. DPX Series 1. Load the version specific diagnostic software from the Tools disk – from a DOS prompt type: A:/diags/diagnos load c:/lunar 2. Enter the diagnostic software – from a C:\LUNAR prompt type: diags 3. Choose option 5 Static Counter QUALITY SYSTEM DOCUMENT

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GE Medical Systems LUNAR

DOC ID: DXSE0012

REV: G

DATE: 2/28/02

CO: L10173

ii. EnCORE based systems 1. Place the scanner in Service Mode a. Options / User Options / check the check box for Service – Enter Password (Smile sw ver 1.0 – 2.05 or Award ver 2.10 +) 2. Go to Tools / Diagnostics / Scanner X-ray 3. Enter desired kV and ma – click on ramp NOTE: Be sure to use your anti-static wrist strap when working on or near circuit board assemblies. . 5. Wedge Test (Rollover Test – DPX Series Only) a. Select the Static Counter from the initial menu. When the static counter screen appears, use the arrow key to move the cursor to Operating Voltage, and enter 76.0. b. Move the cursor to Tube Current and enter the number 150. c. Set the "Repeat" number to 20 and the "Printer" to ON. i. If the AGS is operating properly, the low channel counts will be approximately 600,000 to 800,000 counts, and there will be fewer high channel counts in the range of approximately 400,000 to 700,000. Both counts will be stable to approximately +/- 3000 counts from one sample to the next. d. Place the aluminum wedge test tool on the top of the collimator, with the thin edge toward the collimator’s larger aperture, and the thick edge away from the aperture. Insure that the aluminum wedge is NOT in the beam. e. Press and the shutter will open. Allow a 7 samples to appear on the monitor, and then slowly move the Aluminum Wedge through the radiation beam, starting with the thin edge of the wedge. f. Move the wedge very slowly until the beam reaches an aluminum thickness of approximately 2 mm. g. In the results displayed on the monitor, note the sample number where the high channel air counts begin to be reduced. At this point the counts in both channels should be reduced for the following samples. In other words: both the high and low channel counts must decrease consistently as the wedge enters the beam. h. If the low channel counts increase at any point instead of decreasing, the AGS is not properly adjusted or the detector is failing. i. This may cause "bone points" or white pixels in the image around the outside of a patient's Total Body scan and or white streaks in femur scans. QUALITY SYSTEM DOCUMENT

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GE Medical Systems LUNAR i.

DOC ID: DXSE0012

REV: G

DATE: 2/28/02

CO: L10173

Run the AGS wedge test and verify that it passes attach results to PM Check sheet.

6. Alignment verification / Mechanical / Cabling check a. Run Air Matrix Scan i. Remove the tabletop if it is on. ii. In DIAGS select F4 QUALITY ASSURANCE TESTS, select option 3 – PERFORM AIR MATRIX SCAN. Choose 1 - Perform A Scan. Change the number of lines to the maximum value, also change the number of steps to the maximum value. iii. Note the filename here_____________________________. This will have to be entered to analyze the data (filename format: XM followed by the 4-digit system number followed by MO.01A. Subsequent scans have extensions 01B, 01C, etc.) Then Press Esc to continue. iv. Remove the detector collimator (non-IQ / MD systems only) and install the Air Matrix Piece (attenuation insert) or tape a 0.25 inch piece of aluminum over the detector (over on top of the collimator) to reduce the intensity of the beam. v. Press Esc to begin the scan. The scan will take approx. 30 minutes to complete. NOTE: If anything passes through the beam during this test, IT WILL FAIL. vi. Analyze the Air Matrix scan in DIAGS by selecting option F4 QUALITY ASSURANCE TESTS then select option 4 ANALIZE AIR MATRIX SCAN. vii. Enter the Air Matrix file name when prompted and press the enter key. viii. All categories must pass, see table 1 for Air Matrix values. Category Limit Chi Squared 45 Skew +/- 0.07 Kurtosis +/- 0.07 Table 1: Failure Limits for the Air Matrix Test ix. Print the overall values by answering Y (yes) when the software prompts x. Return the printout of the passing Air Matrix with the PM Checksheet report (DXSE0038).

QUALITY SYSTEM DOCUMENT

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GE Medical Systems LUNAR

DOC ID: DXSE0012

REV: G

DATE: 2/28/02

CO: L10173

xi.

If any categories fail, check the deviation image for possible electronic or alignment problems, consult GE-Lunar OLC for assistance. xii. Run a Daily QA from the system software, or a Peak from the diagnostic software, before trying the Air Matrix. xiii. Once an acceptable Air Matrix scan is printed, delete the Air Matrix files (these files begin with "XM" or "XP" plus the System Number, and they are generally the only files beginning with "X" in the C:\LUNAR subdirectory). b. Beam Wobble scan (Prodigy systems with software version 2.20 and greater DXAP2011) or Alignment scan (Prodigy systems with software versions lower than 2.20 and DPX-NT/MD+ systems- DXAP3001) as appropriate and verify that it passes (attach the results). 7. Limit Switches a. Verify Limit Switch distances (DPX series Diags – F1 Limit Switch Diagnostics / 1 Limit to Limit Distance; enCORE systems - tools / Diagnostics / scanner motion b. DPX Series Only - Home the scanner c. Mark the home position on the Home Jig

QUALITY SYSTEM DOCUMENT

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GE Medical Systems LUNAR

DPXIQ / MD180 or DPXα w/ 4.1d or greate r host

DPXL

DPXIQ / MD240 or DPXL w/ 4.1d or greate r host

DPXSF

10920 – 10960

1078010820

1244 01248 0

1243012470

13360 – 13400

1328013320

1988 01992 0

10920 – 10960

1078010820

13360 – 13400 w/ 3.63 host

1328013320

DPXα

(4-3) Transverse Steps

(1-2) Longitudina l Steps

(3-4) Transverse Steps

(2-1) Longitudina l Steps

DOC ID: DXSE0012

REV: G

DATE: 2/28/02

CO: L10173

DPXSF w/ 4.1d or greate r host

PRODIGY

PRODIGY

240cm Table

180cm Table

1092 0– 1096 0

1078010820

12475 +/- 25

12475 +/- 25

12450 +/- 20

12450 +/- 20

1973019770

4225 – 4265

41954235

19890 +/- 35

13790 +/- 35

19605 +/- 20

13530 +/-20

1244 0– 1248 0

1243012470

1092 0– 1096 0

1078010820

12475 +/- 25

12475 +/- 20

12450 +/-20

12450 +/- 20

1988 0– 1992 0 w/ 3.63 host

1973019770

4225 4265 w/ 3.63 host

41954235

19890 +/- 35

13790 +/- 35

19605 +/- 20

13530 +/- 20

DPXNT / MD+ 240c m Table

DPXNT/MD+ 180cm Table

8. Replace the table top and screw down. a. DPX Series Only – Insure Home position is correct by using the Home Jig b. If necessary adjust limit switches 9. Daily QA Tests a. DPX Series only – check the peak setting on the QA last run i. If peak is not 500 +/- 25 units adjust the peak 1. The voltage to the detector is controlled by the adjustment of the potentiometer on the SBC board labeled HV ADJ - R43. 2. The voltage at TP18 of the SBC is equal to the detector voltage divided by 1000. If R43 is adjusted to decrease the voltage at TP18 by 0.001, the peak will increase by 5 units. 3. The last peak value obtained during a Quality Assurance scan is stored in the Quality Assurance History database file. QUALITY SYSTEM DOCUMENT

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It is the responsibility of the user to verify this document originated from the controlled master and is the active revision prior to use. This document contains confidential or proprietary information of GE Lunar. Neither the document nor the information therein is to be reproduced, distributed, used or disclosed, either in whole or in part, except as specifically authorized by GE Lunar.

GE Medical Systems LUNAR

DOC ID: DXSE0012

REV: G

DATE: 2/28/02

CO: L10173

If the next peak value obtained differs from the last value stored in the database by more than 50 units, the Quality Assurance scan will fail. If the peak must be shifted by more than 50 units to return it to 500 units +25, the peak must be adjusted in steps of less than 50 units (40 unit steps are recommended). 4. A complete QA must be run 5. between each step to update the Quality Assurance History database file. 6. If the software peak setting corresponds to where both the high and low channel counts are at a maximum, (see fig. 6.3) follow the steps outlined below. The graph on the QA will look similar to the one shown in fig 6.3 with the dashed vertical line (where the software thinks the peak is) on the graph at a point where both the high and low energy plots are maximized (the dashed curved lines). If the graph on the QA is unlike fig 6.3, go to part B of this procedure. 7. select "Peak / Set AMP Gain", then select "Perform Peak" and [Esc] to run the peak. Observe the results generated by the QA to determine if the software has selected the Amplifier Setting where both high and low channel counts are at a maximum. If not go to part B. 8. 3. If the peak requires adjustment, (is not within +/- 25 units of 500) connect a voltage meter to the SBC at TP18 (see fig 6.2). Put the meter to the VDC scale and record the voltage reading (e.g. 0.703VDC 9. Using the voltage recorded in step 3 and the peak value recorded in step 2 determine the appropriate voltage adjustment for R43. 10. To determine voltage adjustment: a. If Peak >500: /5 * + Old VTP18

New

VTP18

= (Current Peak – 500)

b. Peak