Siemens MAMMOMAT NovationDR User manual

MAMMOMAT Novation
DR
English
Print No.: SPB7-250.812.02.01.02 Doc. Gen. Date: 02.04
Replaces: N/A
© Siemens AG 2004
The reproduction, transmission or
use of this document or its contents
is not permitted without express
written authority. Offenders will be
liable for damages. All rights,
including rights created by patent
grant or registration of a utility
model _or_design,_are_reserved.
SP
FFDM-S Service Manual DRC
Installation Instructions

DirectRay
®
for Siemens
Full Field Digital Mammography
(FFDM-S)
Service Manual
Direct Radiography Corp.
February 5, 2004
Document No. MAN-00190

February 5, 2004
The information contained in this manual is confidential and proprietary to Direct
Radiography Corp. This information is provided only to authorized representatives
of Direct Radiography Corp. customers solely for the purpose of facilitating the use
of Direct Radiography products. No information contained herein may be disclosed
to any unauthorized person for any purpose whatsoever without the prior written
consent of Direct Radiography Corp.
The information in this document is subject to change without notice.
Copyright 2004 by Direct Radiography Corp. All rights reserved.
Printed in the U.S.A.
DirectRay is a registered trademark of Direct Radiography Corp. All other
trademarks, registered trademarks, and product names used within this document
are the property of their respective owners.
Direct Radiography Corp.
600 Technology Drive
Newark, DE 19702 USA
Telephone:
U.S.A. only: [phone]
International: [phone]
Fax: [phone]
Authorized European Representative:
Hologic Europe - Horizon Park
Leuvensesteenweg 510, BUS 31
1930 Zaventem, Belgium

February 5, 2004 iii
Contents
About This Manual
Intended Use.................................................................................................................... vii
Organization..................................................................................................................... vii
Conventions Used in This Manual................................................................................... viii
Chapter 1: Introduction
What Is the DirectRay FFDM-S System?....................................................................... 1-1
General Safety and Compliance Information ................................................................. 1-2
Safety Precautions................................................................................................... 1-2
General Use Cautions and Warnings ...................................................................... 1-2
United States Federal and State Regulations.......................................................... 1-2
IEC Regulations....................................................................................................... 1-2
Manufacturer’s Responsibility .................................................................................. 1-2
Caution Regarding Small-Detail Object Imaging ..................................................... 1-3
Restrictions on Use ................................................................................................. 1-3
Detector Safety and Compliance Information................................................................. 1-4
Environment............................................................................................................. 1-4
Certification.............................................................................................................. 1-4
Classification............................................................................................................ 1-4
Warnings, Cautions, and Notes ............................................................................... 1-5
Symbols Used.......................................................................................................... 1-6
PXCM Safety and Compliance Information.................................................................... 1-7
Environment............................................................................................................. 1-7
Certification.............................................................................................................. 1-7
Classification............................................................................................................ 1-7
Warnings and Cautions ........................................................................................... 1-7
Chapter 2: Theory of Operation
Normal Operations Sequence........................................................................................ 2-1
Communication Between the PXCM and the Generator During an Exposure............... 2-3
Additional Information About AEC Mode ................................................................. 2-3
DirectRay Technology..................................................................................................... 2-8
Indirect Versus Direct X-ray Capture........................................................................ 2-8
The DirectRay Detector ........................................................................................... 2-9

iv February 5, 2004 FFDM-S Service Manual
Layer Structure....................................................................................................... 2-10
Electronic Readout................................................................................................. 2-11
Chapter 3: Installation
Unpacking the DirectRay Hardware Components .......................................................... 3-2
Unpacking the DirectRay Detector ........................................................................... 3-2
Hardware Installation Information................................................................................... 3-5
DirectRay Detector Installation................................................................................. 3-5
DirectRay PXCM Installation .................................................................................... 3-6
DirectRay Interface Card Installation........................................................................ 3-7
Fiber Optic Cable Installation and Care Guidelines ................................................. 3-8
Handling............................................................................................................. 3-8
Connecting......................................................................................................... 3-8
Cleaning............................................................................................................. 3-8
Chapter 4: Calibrating the AEC
When AEC Calibration Should Be Performed................................................................. 4-1
The Three Calibration-Related Procedures .................................................................... 4-1
Starting the AEC Calibration Tool ................................................................................... 4-2
Viewing Version Information and Exiting the Tool..................................................... 4-3
Main Window Functions and Options....................................................................... 4-3
Determining the Half Value Layer (HVL)......................................................................... 4-5
Determining the Entrance Skin Exposure (ESE) ............................................................ 4-8
Generating the Goal Image .......................................................................................... 4-11
Copying Goal Images ................................................................................................... 4-13
Chapter 5: PXCM Web Tool
When PXCM Web Functions Should Be Used ............................................................... 5-1
Opening the PXCM Web Tool Home Page ..................................................................... 5-1
Function Security Levels and Login Prompts ................................................................. 5-2
Detector Functions ......................................................................................................... 5-3
Viewing Information About the Detector................................................................... 5-4
Viewing Detector Log Files ...................................................................................... 5-6
Upgrading Detector Software Components.............................................................. 5-8
Powering the Detector On and Off ........................................................................... 5-9
PXCM (Brick) Functions ............................................................................................... 5-10
Viewing Information About the PXCM.................................................................... 5-11
Viewing PXCM Log Files........................................................................................ 5-13
Viewing PXCM Application Information.................................................................. 5-15
Viewing PXCM AEC Configuration Information...................................................... 5-16
Viewing Media Converter Board (MCB) Information
and Upgrading Its Firmware................................................................................ 5-18

February 5, 2004 v
Upgrading the PXCM Software.............................................................................. 5-20
Rebooting the PXCM............................................................................................. 5-21
Shutting Down the PXCM...................................................................................... 5-22
Generator Functions .................................................................................................... 5-23
Viewing Information About the Generator.............................................................. 5-24
Viewing and Modifying the Generator Configuration ............................................. 5-26
Factory Service Functions............................................................................................ 5-28
Chapter 6: Maintaining Image Quality
DirectRay Detector Calibration....................................................................................... 6-1
What Calibration Does............................................................................................. 6-1
When to Calibrate the DirectRay Detector............................................................... 6-1
Troubleshooting Image Quality....................................................................................... 6-2
Chapter 7: Troubleshooting Guidelines
General Troubleshooting Guidelines .............................................................................. 7-1
Interpreting Results from PXCM Self-Test ..................................................................... 7-1
Interpreting the PXCM Status LEDs .............................................................................. 7-2
Reporting DirectRay Log Information............................................................................. 7-2
Chapter 8: Replacement
Replacement Guidelines ................................................................................................ 8-1
Packing a DirectRay Detector for Shipment ................................................................... 8-2
Appendix A: Specifications
DirectRay Detector, PXCM, and Interface Card General Specifications ........................ A-1
Electrical......................................................................................................................... A-2
DirectRay Detector .................................................................................................. A-2
DirectRay PXCM...................................................................................................... A-2
Environment ................................................................................................................... A-2
Transit/Storage......................................................................................................... A-2
DirectRay Detector ............................................................................................ A-2
Operating ................................................................................................................. A-2
DirectRay Detector ............................................................................................ A-2
PXCM Connector Locations and Pinouts....................................................................... A-3
DirectRay Detector-to-PXCM Connection ............................................................... A-3
PXCM-to-Generator Connection.............................................................................. A-4
Appendix B: Field Replaceable Units

vi February 5, 2004 FFDM-S Service Manual
THIS PAGE IS INTENTIONALLY BLANK.

February 5, 2004 vii
About This Manual
This manual contains service information for the DirectRay Full Field Digital
Mammography (FFDM-S) system components. It includes an overall description of
how the system operates as well as providing detailed service support procedures
such as installation, calibration, and troubleshooting.
Intended Use
Digital images can be viewed, stored, or printed. The system provides a digital
image capture capability for radiographic examinations for mammography.
Organization
Chapter 1: Introduction
Provides a description of the DirectRay FFDM-S components.
Chapter 2: Theory of Operation
Explains the sequence of internal operations that occur with system components
during exposures. It also describes the DirectRay technology used in the DirectRay
Detector.
Chapter 3: Installation
Provides guidelines for installing the hardware components of the DirectRay
FFDM-S system
Chapter 4: Calibrating the AEC
Describes how to calibrate the AEC by generating a goal table for a desired
target/filter combination and loading it into the DirectRay Power and X-ray
Control Module (PXCM).
Chapter 5: PXCM Web Tool
Describes Detector- and PXCM-related service tasks using the DirectRay PXCM
Web Tool.
Chapter 6: Maintaining Image Quality
Contains information to help maintain acceptable image quality.
Chapter 7: Troubleshooting
Provides guidelines on how to troubleshoot the DirectRay components.
Chapter 8: Replacement
Provides replacement guidelines for the DirectRay system components, and
explains how to pack the Detector for shipment back to Direct Radiography Corp.

viii February 5, 2004 FFDM-S Service Manual
Appendix A: Specifications
Provides specifications for the DirectRay FFDM-S components.
Appendix B: Field Replaceable Units
Provides a listing of the FRUs for the DirectRay FFDM-S components.
Conventions Used in This Manual
This manual uses three types of special messages to emphasize information or
point out potential risks to personnel or equipment. A sample of each message type
follows.
NOTE: Notes provide additional information, such as expanded explanations, hints, or reminders.
CAUTION Cautions point out procedures that you must follow precisely to avoid
damage to equipment, loss of data, or corruption of files in software applications.
WARNING Warnings point out procedures that you must follow precisely to avoid injury
to yourself or others.
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February 5, 2004 1-1
1
Introduction
This chapter provides the general overview of the DirectRay Full Field Digital
Mammography (FFDM-S) system and its components. It also includes safety and
compliance information.
What Is the DirectRay FFDM-S System?
The DirectRay FFDM-S system is composed of the following components in a
direct-to-digital X-ray mammography imaging system:
• The DirectRay Detector, which converts X-rays into digital data
• The DirectRay Power and X-ray Control Module (PXCM), which acts as the
interface between the generator, the DirectRay Detector, and the FFDM-S
Acquisition Workstation software.
• The DirectRay Interface card, a PCI card located in the Acquisition
Workstation, which provides the fiber optic cable connection between the
PXCM and the Acquisition Workstation.
These components are implemented with a generator, tube stand, bucky, and
Acquisition Workstation to form a complete mammography system.
Figure 1-1.
DirectRay FFDM-S Hardware Oomponents
GS20_419.cdr
Detector PXCM Interface Card

1-2 February 5, 2004 FFDM-S Service Manual
General Safety and Compliance Information
Safety Precautions
• Observe all warnings and cautions in the procedures.
• Follow all safety labels on the equipment.
General Use Cautions and Warnings
United States Federal and State Regulations
DirectRay FFDM-S systems conform to the United States Code of Federal
Regulations, 21 CFR 1020.30 “Diagnostic X-Ray Systems and their major
components.” However, additional state regulations may apply for X-ray products.
This may require notifying your state regulatory agency about your installation
and/or operator training and certification.
It is the responsibility of the user to contact the applicable state radiation control
agency to verify that your installation is in compliance with regulations in your
state governing installation and use of X-ray equipment.
IEC Regulations
Software used in the DirectRay FFDM-S system was developed using
IEC 60601-1-4 as a guide.
Manufacturer’s Responsibility
This equipment is sold with the understanding that Direct Radiography Corp., its
agents and representatives, do not accept any responsibility for overexposure of
patients or personnel to X-radiation.
Furthermore, Direct Radiography Corp. does not accept any responsibility for
overexposure of patients or personnel to X-radiation generated by this equipment
as a result of poor operating techniques or procedures.
Also, no responsibility is assumed for any unit that has not been serviced and
maintained in accordance with the technical service manual, or which has been
modified or tampered with in any way.
CAUTION Federal (USA) law restricts this device to sale by or on the order of a physician (or
properly licensed practitioner)
.
WARNING The DirectRay FFDM-S system includes no user serviceable parts. For service
assistance, contact the vendor who supplied the system.

Introduction February 5, 2004 1-3
Caution Regarding Small-Detail Object Imaging
As with all digital imaging devices, there is the potential that small-detail
structures, high-contrast edge structures, and fine-line structures with a repeating
pattern could appear differently in the digital image than in an image created with
an analog device—such as screen–film system—or with another digital device
having smaller individual detector elements. For example, for a sharp-edged
object, the edges of that object may appear to have “stair-steps” when in fact the
object edge does not have such structure. This is an effect of digital undersampling.
For small-detail objects having a size on the same order of magnitude as an
individual pixel or smaller, the apparent contrast of that object can vary based on
the position relative to the individual detector element locations. For example, the
contrast of a single spherical object the same size as a pixel would have a different
appearance if the object were imaged directly overlying a detector element (highest
contrast) or placed at the intersection of four detector elements (lowest contrast).
Objects inherently smaller than individual pixels will have a lower apparent
contrast because of the digital sampling of the analog radiation intensity signal
over an area larger than the small object. In each case, a lower apparent
signal-to-noise can result in reduced visibility of such objects.
Restrictions on Use
The customer is responsible for assuring that accessories used with the DirectRay
FFDM-S system do not degrade the safety of the system.
Accessories and interfacing equipment used in conjunction with the DirectRay
FFDM-S system and located outside the patient environment may be exempt from
EN60601-1. Such equipment must, however, conform to EN60601-1-1 and
therefore to standards applicable to information technology equipment such as
EN60950 and to applicable electromagnetic compatibility requirements.

1-4 February 5, 2004 FFDM-S Service Manual
Detector Safety and Compliance Information
Environment
The operating environment is 20° to 35°C (68° to 95°F), 10 to 80% Relative
Humidity (non condensing). Make sure the ventilation openings at the rear of the
detector are not obstructed. For storage and transportation, the temperature range
must stay within 10° to 40°C (50° to 104°F) or permanent damage may occur. Such
damage could be considered misuse and may not be covered under warranty.
Do not autoclave this equipment.
Certification
UL Recognized Component certified to be in compliance with applicable
requirements of:
• UL 2601-1, Second Edition including Amendments 1 and 2
• CAN/CSA C222 No. 601.1-M909
Use of the FFDM-S with equipment not complying with equivalent safety
requirements may lead to a reduced level of safety in the resulting system. There
must be evidence that added equipment has been certified for safety in accordance
with the appropriate IEC 601-1 and/or IEC 601-1-1 harmonized national standard.
Otherwise use within the defined Patient Vicinity is not approved. Testing of the
FFDM-S in combination with the end use equipment shall include leakage current
test, ground continuity tests, temperature tests and other tests as required by the
appropriate standards. The maximum operating temperatures of certain safety
components, as defined in the applicable safety standards, must not be exceeded in
the end use installation to maintain the intended safety. The FFDM-S is intended
to be installed as part of x-ray equipment and serviced only by persons trained and
approved to work on that specific equipment, using the appropriate tools.
Classification
With reference to subclause 5 of IEC 60601-1:
• Protection against electric shock (5.1, 5.2) Class I.
• Applied Parts: Type B Applied Parts.
• Protection against harmful ingress of water (5.3) Ordinary.
• Degree of safety in the presence of flammable anesthetics or oxygen (5.5). Not
suitable for use in the presence of flammable anesthetics or oxygen.
• Mode of Operation (5.6): Continuous.

Introduction February 5, 2004 1-5
Warnings, Cautions, and Notes
NOTE: This product must be returned to the manufacturer for proper disposal of the selenium and
related electronic materials.
WARNING A Protective Earth Ground connection to the FFDM-S Detector shall be
provided in the end use equipment installation.
WARNING DangerousVoltages are present on some components, printed wiring traces,
and heatsinks. A blown fuse is an indication of a catastrophic failure of circuit
components. Unauthorized replacement may result in a risk of fire.
CAUTION Some of the electronic components used in this product may be damaged
by static electricity or electrostatic discharge. Unpack and handle using appropriate
precautions.
CAUTION Each image detector is provided with a CD-ROM containing data for initial
gain calibration and defect mapping. The gain calibration process must be performed
again when installed at the end user site to compensate for variations in the specific
x-ray tube, breast tray, compression paddle, grid, and all other parts of the image path.
Any dirt, debris, or foreign objects in the path between X-ray source and image
detector elements at time of calibration may adversely affect subsequent images.
Calibration should be repeated at regular intervals to maintain image quality. Defect
mapping can be verified and updated by authorized service personnel.
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1-6 February 5, 2004 FFDM-S Service Manual
Symbols Used
Danger! Hazardous Voltages are present within this equipment.
Attention! Consult this accompanying document for valuable information on
the safe and effective use of this product.
This thermometer symbol indicates the recommended operating
temperature range of 20° to 35°C (68° to 95°F). A similar symbol appears on
the product packaging indicating that during storage and transportation the
temperature must stay within 10° to 40°C (50° to 104°F).
Special Cleaning Instructions:
Do not spray cleaning solution directly on the equipment. Instead, moisten
cloth with the solution and wipe the Detector.
Fragile - Handle with care.
Do not immerse the equipment in liquid.
This product contains no user serviceable parts. Assembly of this product is
done under controlled clean room conditions. Exposing the more sensitive
internal parts lesser environments may permanently affect product
performance.
Do not to operate this equipment in the presence of flammable anesthetics
or high levels of oxygen. The gas bottle and flame are a visual reminder of a
hazard that usually cannot be seen.
This equipment has been determined to be Type B equipment providing a
particular degree of protection against electric shock.
+35 C
+10 C
+95 F
+50 F

Introduction February 5, 2004 1-7
PXCM Safety and Compliance Information
Environment
The operating environment is 10°to 50°C (50°to 122°F), 10 to 80% Relative
Humidity (non condensing).
Certification
UL Recognized Component certified to be in compliance with applicable
requirements of:
•UL 2601-1, Second Edition including Amendments 1 and 2
•CAN/CSA C222 No. 601.1-M909
Use of the PXCM-S with equipment not complying with equivalent safety
requirements may lead to a reduced level of safety in the resulting system. There
must be evidence that added equipment has been certified for safety in accordance
with the appropriate IEC 601-1 and/or IEC 601-1-1 harmonized national standard.
Otherwise use within the defined Patient Vicinity is not approved. Testing of the
PXCM-S in combination with the end use equipment shall include leakage current
test, ground continuity tests, temperature tests and other tests as required by the
appropriate standards. The maximum operating temperatures of certain safety
components, as defined in the applicable safety standards, must not be exceeded in
the end use installation to maintain the intended safety. The PXCM-S is intended
to be installed within X-ray equipment and serviced only by persons trained and
approved to work on that specific equipment, using the appropriate tools.
Classification
With reference to subclause 5 of IEC 60601-1:
•Protection against electric shock (5.1, 5.2) Class I.
•Protection against harmful ingress of water (5.3) Ordinary.
•Degree of safety in the presence of flammable anesthetics or oxygen (5.5). Not
suitable for use in the presence of flammable anesthetics or oxygen.
•Mode of Operation (5.6): Continuous.
Warnings and Cautions
WARNING DangerousVoltages are present on some components, printed wiring traces,
and heatsinks. A blown fuse is an indication of a catastrophic failure of circuit
components. Unauthorized replacement may result in a risk of fire.
CAUTION This unit includes a lithium battery. Do not attempt to disassemble or
recharge it. Do not dispose of the battery in fire.

1-8 February 5, 2004 FFDM-S Service Manual
CAUTION Some of the electronic components used in this product may be damaged
by static electricity or electrostatic discharge. Unpack and handle using appropriate
precautions.
CAUTION Dielectric strength test caution: (Statement from Condor DC Supplies Inc.
regarding their GSM28-5 power supply) "When performing Dielectric Strength Tests,
catastrophic failure of the unit may result if a Dielectric Strength test voltage greater
than 1800 Vac is applied between primary and secondary circuits. The components
providing isolation from primary to secondary cannot be tested while installed in the
power supply without overstressing basic (primary to ground) insulation. All isolating
components are individually 100% tested at 4800 Vac prior to installation."

February 5, 2004 2-1
2
Theory of Operation
This chapter explains the sequence of internal operations that occur with system
components during exposures. It also describes the DirectRay technology used in
the DirectRay Detector.
Normal Operations Sequence
A flowchart of the normal workflow is illustrated in Figure 2-1 on page 2-2.
Understanding the normal operation of the system facilitates troubleshooting to
isolate the possible causes of problems.

2-2 February 5, 2004 FFDM-S Service Manual
Figure 2-1. Normal Workflow of the X-ray System
Technologist Receives
Next Patient
Exam Specific Settings
are Displayed
Technologist Identifies
Patient in System
Patient, and Exam
Information is
Displayed on
Acquisition Workstation
Technologist Positions
Patient
Technologist Acquires
Image
Technologist
Adjusts Image
Technologist Modifies
Technique Factors
Technologist Confirms
Patient Identity on
Acquisition Workstation
Technologist Selects
Existing Procedure
from List
Technologist
Selects New
Procedure from List
Is the
Procedure
Listed?
Technologist
Modifies the Exam
Settings
?
Technologist
Accepts Image?
Adjust
Accept
No
No
Reject
No
No
Yes
Yes
Yes No
Procedure Done?
Really
Reject?
GS20_410.cdr
Yes
Image Sent
to Reject Bin
Technologist Closes
Procedure

Theory of Operation February 5, 2004 2-3
Communication Between the PXCM and the Generator
During an Exposure
The interface between the DirectRay Power and X-ray Control Module (PXCM) and
the Generator consists of seven hardware signals and regular exchange of
messages over an RS232 serial communication link.
There are two exposure operating modes: Manual and Automatic Exposure Control
(AEC). The exposure sequence is slightly different between the two modes. The
main difference is that the AEC exposure actually consists of two exposures: a
short pre-exposure; followed by the measurement, calculation, and transfer of the
required mAs value from the PXCM to the Generator; followed by the main
exposure.
Figure 2-2 on page 2-4 and Figure 2-3 on page 2-5 show the signals and their
relative occurrence in time.
NOTE: The PXCM is also referred to as the “brick.” Therefore, you will see the terms “PXCM” and
“brick” used interchangeable throughout this topic.
Additional Information About AEC Mode
During AEC mode:
1. A 5-mAs pre-exposure is made.
2. The actual mAs of the pre-exposure is sent from the Generator to the PXCM in
a code-S message.
3. The PXCM collects the resulting pixel values, binned together in super pixels
(128 x 128 pixels), from the Detector.
4. Using these super pixel values and the exposure parameters (for example, kV
and speed, supplied in the code-X message) of the exposure, the PXCM
calculates the required mAs value (which depends on the desired pixel value)
to be used for the main exposure.
5. The calculated mAs value is made available to the Generator by a code-B
message from the PXCM.
6. Once the calculated mAs value has been set up in the Generator, the Generator
sends a code-Y message to the PXCM.
7. The PXCM again activates its DR_DET_RDY_FOR_EXP_ signal; the
Generator starts the grid and, when in position, starts the actual exposure.
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