Artwork and Signature File For: 9-500-0246 "MANUAL, AFFINITY OPERATOR"

Artwork and Signature File for:
9-500-0246 “MANUAL, AFFINITY OPERATOR”
Artwork consists of:
• Ninety-two (92) 8 ½ inch x 11 inch pages.
REV AUTHORED BY DATE

J. SHARP 3/2/2006
REV DRAFTED BY DATE
DANBURY, CT 06810
B. MOSES 3/6/2006
PROPRIETARY INFORMATION: TITLE DOCUMENT NUMBER REV
The content of this document is the
exclusive property of Lorad and may MANUAL, AFFINITY AW-00226 006
not, without prior written permission
of Lorad, be reproduced, copied or OPERATOR
used for any purpose whatsoever. ARTWORK SIZE A SHEET 1 OF 1
ENG-0034-T33, Rev. 001
Operator’s Manual
for Affinity Series Mammography Systems
Part Number 9-500-0246
Revision 006
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© Copyright Hologic 2006. All rights reserved. Printed in USA.
Hologic and the Hologic Logo are registered trademarks of Hologic, Inc. Other trademarks registered or used by Hologic and its divisions and subsidiaries in the United States and
other countries include: Affinity, Affinity Platinum, Auto Film ID, “Clarity of Vision,” Dataport, HTC, LORAD, “LORAD A Hologic Company,” LORAD DSM, LORAD Elite, M-IV, M-IV
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This manual was originally written in English.

Operator’s Manual
Table of Contents
List of Figures ...................................................................................................... vii
List of Tables ........................................................................................................ ix
Preface ................................................................................................................. xi
1.0 Overview ................................................................................................................................. xi
2.0 Intended Use ............................................................................................................................ xi
3.0 Product Complaints .................................................................................................................. xi
4.0 User Training ............................................................................................................................ xi
5.0 Quality Control ........................................................................................................................ xi
6.0 Terms and Definitions ............................................................................................................. xii
7.0 Warnings, Cautions and Notes ............................................................................................... xiii
8.0 International Symbols ............................................................................................................. xiii
9.0 Using the Operator’s Manual .................................................................................................. xiv
Chapter 1—Introduction .......................................................................................1

1.0 System Description .................................................................................................................... 1
1.1 The C-arm ........................................................................................................................... 1
1.2 The Gantry .......................................................................................................................... 1
1.3 The Control Panel ............................................................................................................... 1
1.4 Mammography System ........................................................................................................ 2
2.0 Safety ........................................................................................................................................ 3
2.1 Radiation Safety .................................................................................................................. 3
2.1.1 The Operator Radiation Shield .................................................................................. 3
2.2 Technologist and Patient ..................................................................................................... 4
2.3 Electrical Safety ................................................................................................................... 5
2.4 Isolation Integrity ................................................................................................................ 5
2.5 Emergency Off Switch ......................................................................................................... 6
2.6 Interlocks ............................................................................................................................ 7
2.6.1 C-arm Movement Interlocks ...................................................................................... 7
2.6.2 Automatic Compression Release Interlock ................................................................. 7
2.6.3 Early Release Interlock ............................................................................................... 7
2.6.4 Cassette Sense Interlock ............................................................................................. 7
2.6.5 Aperture Interlock ...................................................................................................... 7
2.6.6 Mirror and Filter Interlocks ........................................................................................ 7
2.7 External Indicators ............................................................................................................... 7
3.0 Compliance ............................................................................................................................... 8
3.1 Compliance Requirements .................................................................................................. 8
3.2 Compliance Statements ....................................................................................................... 8
3.3 Label Locations ................................................................................................................... 9
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Chapter 2—System Controls and Indicators ....................................................... 11

1.0 Affinity System Controls and Indicators ................................................................................... 11
2.0 The Control Panel Controls and Indicators .............................................................................. 12
3.0 Gantry Controls and Indicators ............................................................................................... 13
3.1 Circuit Breaker ................................................................................................................. 13
3.2 C-Arm Rotation Angle Displays ........................................................................................ 14
3.3 Footswitch Controls .......................................................................................................... 14
3.4 Emergency Off Switch ...................................................................................................... 14
3.5 X-ray Exposure Footswitch ................................................................................................ 14
4.0 Compression Device Controls and Indicators .......................................................................... 15
5.0 The C-arm Keypads ................................................................................................................. 16
6.0 Affinity Controls and Functional Tests ..................................................................................... 17
7.0 System Startup Procedures ...................................................................................................... 19
7.1 Pre-Startup Tests ............................................................................................................... 19
7.2 Turning On the System ..................................................................................................... 19
7.3 Post Startup Tests .............................................................................................................. 19
8.0 System Shutdown Procedures ................................................................................................. 19
Chapter 3—The User Interface ........................................................................... 21

1.0 Introduction ............................................................................................................................ 21
2.0 The Run Mode Screen ............................................................................................................. 22
2.1 Exposure System Displays ................................................................................................ 23
2.2 The Message Area ............................................................................................................ 23
2.3 The Status Area ................................................................................................................. 23
3.0 The User Defaults Screen ........................................................................................................ 24
4.0 The Exposure Defaults Screen ................................................................................................. 25
4.1 An Overview of the Exposure Defaults Screen .................................................................. 25
4.2 Setting Defaults for Each Exposure Mode .......................................................................... 26
4.2.1 Auto-Filter Mode ..................................................................................................... 26
4.2.2 Auto-kV Mode ........................................................................................................ 26
4.2.3 Auto-Time Mode ..................................................................................................... 27
4.2.4 Manual Mode ......................................................................................................... 27
4.2.5 Mag Auto-kV Mode ................................................................................................. 28
4.2.6 Mag Auto-Time Mode ............................................................................................. 28
4.2.7 Mag Manual Mode .................................................................................................. 29
4.3 Setting the Default Exposure Modes .................................................................................. 29
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Chapter 4—Accessories .......................................................................................31

1.0 Introduction ............................................................................................................................. 31
2.0 The Patient Face Shield ........................................................................................................... 31
3.0 Bucky Devices .........................................................................................................................32
3.1 Installing and Removing the Bucky Device ....................................................................... 32
3.2 Loading and Unloading the Bucky Device ........................................................................ 33
3.3 Integrated Bucky Markers .................................................................................................. 33
3.3.1 Using the Markers ................................................................................................... 33
3.3.2 Positioning the Markers ........................................................................................... 33
3.3.3 Aligning the Markers ...............................................................................................33
3.3.4 Removing and Replacing the Markers ...................................................................... 34
4.0 Cassette Holder and Magnification Platform ............................................................................34
4.1 Installing and Loading the Cassette Holder for Magnification Studies ................................ 34
4.2 Installing the Magnification Platform ................................................................................. 35
4.3 Removing the Magnification Platform ............................................................................... 35
4.4 Removing the Cassette and Cassette Holder ...................................................................... 35
5.0 Magnification Table ................................................................................................................. 36
5.1 Installing the Magnification Table ..................................................................................... 36
5.2 Loading the Table ............................................................................................................. 37
5.3 Removing a Cassette ......................................................................................................... 37
5.4 Removing the Table .......................................................................................................... 37
6.0 Compression Paddles .............................................................................................................. 38
6.1 AEC Sensor Markings—Full Field Compression Paddles .................................................... 39
6.2 FAST Paddle Use ............................................................................................................... 39
6.3 Installing and Removing Compression Paddles .................................................................. 40
6.4 Realigning the Paddle Front Edge ...................................................................................... 41
7.0 Apertures ................................................................................................................................. 42
7.1 Available Apertures ........................................................................................................... 42
7.2 Installing and Removing Apertures .................................................................................... 43
7.3 Aperture Compatibility ......................................................................................................43
8.0 Crosshair Device (optional) ..................................................................................................... 44
8.1 Installing and Removing the Crosshair Device ................................................................... 44
8.2 Aligning the Loc Crosshair Device to the Localization Paddle ........................................... 44
9.0 Dual-Function Footswitch(es) .................................................................................................. 45
Chapter 5—Clinical Procedures ..........................................................................47

1.0 Introduction ............................................................................................................................. 47
2.0 System Startup .........................................................................................................................47
3.0 Installation of Accessories ........................................................................................................ 47
4.0 Settings—Exposure Techniques ...............................................................................................47
5.0 Positioning the Patient ............................................................................................................. 47
6.0 Exposure Sequence .................................................................................................................. 48
7.0 Magnification, and Localization Procedures ............................................................................49
7.1 Magnification Procedure ................................................................................................... 49
7.2 Localization Procedure ..................................................................................................... 49
8.0 Labeling the Film (Option) ....................................................................................................... 50
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Chapter 6—Care and Maintenance ..................................................................... 51

1.0 Care and Cleaning .................................................................................................................. 51
1.1 Cleaning and Disinfection ................................................................................................ 51
1.2 Recommendations ............................................................................................................ 51
2.0 Maintenance Schedule ............................................................................................................ 52
2.1 Daily Maintenance Schedule ............................................................................................ 52
2.2 Monthly Maintenance Schedule ....................................................................................... 52
2.3 Semi-Annual Maintenance ............................................................................................... 52
2.4 Annual Maintenance ........................................................................................................ 52
Appendix A—Specifications ................................................................................ 53

1.0 System Requirements and Dimensions .................................................................................... 53
1.1 Electrical Input ................................................................................................................. 53
1.2 Operating Environment .................................................................................................... 53
1.3 Storage Environment ......................................................................................................... 53
1.4 Room Requirements ......................................................................................................... 54
1.5 System Dimensions .......................................................................................................... 54
2.0 C-arm, Compression, and IRSD ............................................................................................... 55
2.1 C-arm ............................................................................................................................... 55
2.2 Compression .................................................................................................................... 55
2.3 Image Receptor Support Device ....................................................................................... 56
3.0 X-ray System ........................................................................................................................... 57
3.1 Automatic Exposure Control ............................................................................................. 57
3.1.1 AEC Mode Operating Range ................................................................................... 57
3.2 HV Generator (in compliance with IEC 60601-2-7) .......................................................... 58
3.3 Modes of Operation ......................................................................................................... 60
3.4 X-ray Source, Filtration, and Collimation .......................................................................... 61
4.0 Accessories ............................................................................................................................. 63
4.1 Compression Paddles ....................................................................................................... 63
4.2 Apertures .......................................................................................................................... 64
4.3 Magnification ................................................................................................................... 64
4.4 Image Receptors ............................................................................................................... 64
Appendix B—Alert Codes and Messages ............................................................. 65

1.0 Alert Codes and Messages ....................................................................................................... 65
Appendix C—Forms and References ................................................................... 67

1.0 Introduction ............................................................................................................................ 67
2.0 System Startup and Clinical Procedure Checklist ..................................................................... 67
3.0 System Default Record Sheets ................................................................................................. 68
4.0 Available Accessories for the Affinity ...................................................................................... 71
5.0 Aperture Compatibility ............................................................................................................ 72
Index ................................................................................................................... 73
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List of Figures
List of Figures
Figure 1-1: Affinity System Description.................................................................................................. 1

Figure 1-2: Affinity Mammography System ............................................................................................ 2
Figure 1-3: Operator Radiation Shield ................................................................................................... 3
Figure 1-4: Location of the Emergency Off Switches and the Circuit Breaker ......................................... 6
Figure 1-5: Affinity Labels Locations (Labels not shown to scale) ........................................................... 9
Figure 2-1: Affinity System Controls and Indicators.............................................................................. 11
Figure 2-2: Affinity Control Panel Controls and Indicators ................................................................... 12
Figure 2-3: The Dual-Function Footswitch........................................................................................... 14
Figure 2-4: Emergency Off Switch Operation....................................................................................... 14
Figure 2-5: Affinity Compression Device Controls and Indicators ........................................................ 15
Figure 2-6: The C-arm Keypads ........................................................................................................... 16
Figure 3-1: Control Panel in Run Mode ............................................................................................... 22
Figure 3-2: The User Default Screen .................................................................................................... 24
Figure 3-3: Overview of the Exposure Defaults Screen......................................................................... 25
Figure 3-4: The Auto-Filter Mode Defaults........................................................................................... 26
Figure 3-5: The Auto-kV Mode Defaults .............................................................................................. 26
Figure 3-6: The Auto Time Mode Defaults Screen................................................................................ 27
Figure 3-7: The Manual Mode Defaults Screen .................................................................................... 27
Figure 3-8: The Auto-kV Mode Defaults Screen ................................................................................... 28
Figure 3-9: The Mag Auto-Time Mode Defaults Screen........................................................................ 28
Figure 3-10: The Mag Manual Mode Defaults Screen .......................................................................... 29
Figure 3-11: Exposure Defaults Setup Screen ....................................................................................... 29
Figure 4-1: Installing the Face Shield ................................................................................................... 31
Figure 4-2: Mounting and Loading the Bucky Device .......................................................................... 32
Figure 4-3: Placement of the Bucky Markers ........................................................................................ 33
Figure 4-4: Mounting and Loading a Cassette Holder .......................................................................... 34
Figure 4-5: Magnification Platform Installation .................................................................................... 35
Figure 4-6: Magnification Table........................................................................................................... 36
Figure 4-7: Affinity Compression Paddles ............................................................................................ 38
Figure 4-8: Installing Compression Paddles.......................................................................................... 40
Figure 4-9: Paddle Alignment .............................................................................................................. 41
Figure 4-10: Paddle Alignment Adjustment Screws.............................................................................. 41
Figure 4-11: Affinity Apertures............................................................................................................. 42
Figure 4-12: Installing Apertures .......................................................................................................... 43
Figure 4-13: Installing the Loc Crosshair .............................................................................................. 44
Figure 4-14: Adjustment Lock Screw and Latch ................................................................................... 44
Figure 4-15: Footswitch Receptacle ..................................................................................................... 45
Figure 4-16: The Dual-Function Footswitch......................................................................................... 45
Figure A-1: System Dimensions ........................................................................................................... 54
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List of Figures
viii P/N 9-500-0246

Operator’s Manual
List of Tables
List of Tables
Table 2-1: The Function keypad Buttons and Indicators ................................................................. 12

Table 2-2: Affinity Compression Device Controls and Indicators ................................................... 15
Table 3-1: Control Panel Display Screens ...................................................................................... 21
Table 3-2: Exposure System Options in the Run Mode ................................................................... 23
Table 3-3: Options in the User Defaults Screen ............................................................................. 24
Table 3-4: Auto-Filter Mode Options ............................................................................................. 26
Table 3-5: Auto-kV Mode Options ................................................................................................. 26
Table 3-6: Auto-Time Mode Options ............................................................................................. 27
Table 3-7: Manual Mode Options .................................................................................................. 27
Table 3-8: Mag Auto-kV Mode Options .........................................................................................28
Table 3-9: Mag Auto-Time Mode Options ..................................................................................... 28
Table 3-10: Mag Manual Mode Options ........................................................................................ 29
Table 3-11: Default Exposure Modes ............................................................................................. 29
Table 4-1: Compression Paddle Applications ................................................................................. 39
Table A-1: AEC Mode Operating Ranges ....................................................................................... 57
Table A-2: kV Versus mA Table ..................................................................................................... 59
Table B-1: Affinity Series Alert Codes and Messages ...................................................................... 65
Table C-1: User Default Settings .................................................................................................... 68
Table C-2: Selected Exposure Technique Defaults ......................................................................... 69
Table C-3: Selected Magnification Device Exposure Technique Defaults ....................................... 70
Table C-4: List of Available Accessories .........................................................................................71
Table C-5: Aperture Compatibility ................................................................................................. 72
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Operator’s Manual
List of Tables
x P/N 9-500-0246
Operator’s Manual
Preface
Overview
Preface
1.0 Overview
The Affinity is a dedicated mammography system that features automatic and manual
exposure modes, a compact Control Panel, and optional film labeling abilities.
2.0 Intended Use

The Affinity is intended to produce radiographic images of the breast. Its specific intended
use is for screening and diagnostic mammography.
3.0 Product Complaints

Any health care professional (for example, customer or user of this system of products) who
has any complaints or has experienced any dissatisfaction in the quality, durability,
reliability, safety, effectiveness, and/or performance of this product should notify Hologic. If
the device malfunctions and may have caused or contributed to a serious injury of a patient,
Hologic should be notified immediately by telephone, fax, or written correspondence.
4.0 User Training

Hologic does not accept responsibility for injury or damage associated with improper or
unsafe system operation. Your Hologic dealer can arrange for training by a mammography
application specialist.
Users must ensure that they receive training on the Affinity with Hologic training programs
prior to use on patients. Hologic training programs address MQSA training regulations in
product labeling to ensure that prospective users are aware of the required eight hours of
training for any medical physicist, technologist, or interpreting physician.
You should refer to this Operator Manual for directions on how to use the Affinity.
5.0 Quality Control

Perform all Quality Control tests at the prescribed frequencies as required under MQSA
regulations. To ensure continued high-level operation of the Affinity, follow the
recommended Quality Control Procedures.
P/N 9-500-0246 xi
Operator’s Manual
Preface
Terms and Definitions
6.0 Terms and Definitions

21 CFR FDA Code of Federal Regulations, Title 21
AEC Automatic Exposure Control
B.E.M. Breast Equivalent Material
Collimator Device at the X-ray tube that is used to restrict the area of
the receptor that is exposed
FAST Paddle Fully Automatic Self-Adjusting Tilt Paddle
Grid Element within the Bucky which reduces scatter radiation
during exposure
HTC High Transmission Cellular Grid
HVL Beam Quality Half-Value Layer
IR Image Receptor
IRSD Image Receptor Support Device
mA milli-Amps
Mag Magnification Mode
mGy milli-Gray
Mo Molybdenum
MQSA Mammography Quality Standards Act
mrad milli-Radiation Absorbed Dose
N Newtons
OD Optical Density
Rh or Rho Rhodium
SID Source to Image Distance
VTA Vertical Travel Assembly
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Preface
Warnings, Cautions and Notes
7.0 Warnings, Cautions and Notes

Definitions of Warnings, Cautions and Notes used throughout this manual are as follows:
WARNING! This alerts you to procedures that you must follow precisely to
avoid causing potentially serious or fatal injury to yourself or
others.
Warning! Warnings point out procedures that you must follow precisely to
avoid injury to yourself or others.
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
Note… Notes indicate important instructions to follow to ensure the proper

operation of the system.
8.0 International Symbols

This section explains the International Symbols used on this system.
Potential Equalization Connection for a conductor other than the Protective

terminal Earth for a direct connection between two or more pieces
of electrical equipment.
Protective Earth terminal Used for the connection of the ground of the line cord or
ground cable of the equipment and no other purpose.
Off Power disconnection from the mains
On Power connection to the mains
WEEE Symbol indicating separate collection for electrical and

electronic equipment
Dangerous Voltage Identifies area of potentially lethal voltage
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Operator’s Manual
Preface
Using the Operator’s Manual
9.0 Using the Operator’s Manual

This manual is divided into seven chapters and three appendices.
Chapter 1—Introduction: This chapter provides an overview of the mammography
system, including component descriptions, patient and user safety, interlocks, and
compliance information.
Chapter 2—System Controls and Indicators: This chapter describes the use and
function of the system controls, readouts, and indicators, and how to turn the system on and
off.
Chapter 3—The User Interface: This chapter describes the Run Mode, User Defaults,
and Exposure Defaults screens. Selecting exposure parameters, setting system defaults, and
responding to prompts are described.
Chapter 4—Accessories: This chapter describes the attachment and use of the system
accessories.
Chapter 5—Clinical Procedures: This chapter suggests a sequence for clinical
applications, including screening, localization and magnification exams.
Chapter 6—Care and Maintenance: This chapter describes how to clean the system
and its components. Directions for general cleaning and disinfection and the care of plastic
accessories are included.
Appendix A—Specifications: This chapter includes the system specifications.
Appendix B—Alert Codes and Messages: This chapter includes a list of Alert Codes
and messages and their meanings.
Appendix C—Forms and References: This chapter includes reproducible pages for
use in the X-ray room and recording system default settings.
xiv P/N 9-500-0246

Operator’s Manual
Chapter 1—Introduction
System Description
1.0 System Description

The Affinity system consists of:
1. C-arm
2. Gantry
3. Control Panel
Figure 1-1: Affinity System Description
1.1 The C-arm

The C-arm houses the X-ray Tubehead, the Compression Device, and the Image Receptor
Support Device. A pivot mechanism connects the C-arm to the Gantry. A 7-Button Keypad
on each side of the C-arm and a 3-Button Keypad on the Tubehead control C-arm
movement, Compression Release, Compression Up/Down, and the Light Field Lamp. The
design of the C-arm permits examination of standing, sitting, or recumbent patients.
1.2 The Gantry

The Gantry houses the electronics that produce the high voltage needed for mammography.
The mechanical assemblies that position the C-arm (height and rotation), the input
transformer, the fuse panel, and most of the system electronics are also in the Gantry. LED
readouts on the left and right side of the Gantry show the C-arm rotation angle.
1.3 The Control Panel

The Control Panel is a compact user interface that mounts to the side of the Gantry or a
remote location. This interactive device houses an LCD screen, a Function Keypad, and an
X-ray Button. The LCD screen displays exposure techniques and system status. The Function
Keypad selects system settings, clears messages, releases compression, and initiates X-rays.
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System Description
1.4 Mammography System
Figure 1-2: Affinity Mammography System
Legend for Figure 1-2

1. C-arm Rotation Angle Display 9. AEC Sensor Handle
2. Emergency Off Switch (3) 10. Image Receptor Support Device
3. Control Panel 11. Compression Paddle
4. Patient Handle 12. Compression Device
5. Operator Radiation Shield 13. Face Shield
6. X-ray Footswitch (optional, not visible) 14. Aperture Slot
7. Footswitch 15. X-ray Tubehead
8. 7-Button Keypad 16. 3-Button Keypad
2 P/N 9-500-0246
Operator’s Manual
Safety
2.0 Safety
Read and understand this Operator’s manual completely before turning the system On.
Always follow all the instructions in this manual.
Hazardous Material Warning!
• The X-ray tube contains a beryllium window that should not be touched.
• Follow all local ordinances or regulations for disposal of the X-ray tube.
• The X-ray tube covers and the image receptor contain lead that should not be touched.
• Follow all local ordinances or regulations for disposal of these covers.
Note… The Affinity does not contain any mercury or latex in its construction.
2.1 Radiation Safety

Hologic does not accept responsibility for injury or damage associated with improper or
unsafe system operation. Your Hologic dealer can arrange for training by a mammography
application specialist.
Warning: To ensure radiological protection, restrict access to the system in

accordance with local regulations.
2.1.1 The Operator Radiation Shield

The optional Operator Radiation Shield (Figure 1-3, Item 1) is permanently attached
to the Gantry by a mounting bracket (2). The shield provides 0.5 mm lead equivalent
protection to the operator, and is required if the Control Panel is mounted to the
Gantry.
Figure 1-3: Operator Radiation Shield
P/N 9-500-0246 3
Operator’s Manual
Safety
Warning: For maximum protection from X-ray exposure, the operator must
keep their entire body behind the Operator Radiation Shield for the
duration of the exposure.
Warning: This X-ray system may be dangerous to patient and operator unless
you use safe exposure factors and follow operating instructions.
Observe all operating and safety instructions before making an X-
ray exposure.
2.2 Technologist and Patient

Only qualified operators should use this system. Operators should be well-versed in the
basic principles of mammography before performing the procedures described in this
manual.
WARNING! It is the responsibility of the user to correct anomalies or

abnormal operation before the system is used, and to arrange
for preventive maintenance by an authorized service engineer.
WARNING! In the event of loss of power, always remove the patient from
the system before re-applying power.
Warning: This system includes motorized equipment. Use care when

adjusting the system for patient use. Observe equipment and
patient at all times during set up. If a chair is necessary, use an
adjustable chair set above its minimum height.
Warning: When examining a patient in a wheelchair, place footswitches out

of the area to prevent accidental activation by the patient or chair.
Warning: Never leave the patient unattended during the exam, especially
when in contact with the mammography system.
Warning: Keep the patient’s hands away from any operator controls (for
example, all buttons and switches) at all times.
4 P/N 9-500-0246
Operator’s Manual
Safety
2.3 Electrical Safety

Only an authorized service engineer should remove covers from the mammography system.
Always refer service needs to an authorized service engineer.
The Affinity is classified as CLASS I, TYPE B permanently connected equipment as per IEC
60601-1. There are no special provisions to protect the system from flammable anesthetics
or ingress of liquids. However, the footswitches are splash-proof as per IPX6 or better.
WARNING! Lethal voltages are present within the interior of this system.
Do not open any of the panels.
WARNING! Electrical equipment used in the presence of flammable

anesthetics or oxygen may cause an explosion.
Caution: Use only recommended accessories with this equipment. Failure to heed
this warning may cause unexpected functions.
2.4 Isolation Integrity
WARNING! To ensure the isolation integrity for the system, attach only
Hologic accessories or options to the system.
WARNING! To ensure proper isolation, maintain a 1.5 meter distance

(approximately 5 feet) between the patient and any non-
patient devices. Non-patient system components must not be
installed in the Patient Area.
1.5m
P/N 9-500-0246 5
Operator’s Manual
Safety
2.5 Emergency Off Switch

There are three Emergency Off Switches on the Affinity, one on each side of the Gantry
(Figure 1-4, Item 3) and one on the rear face of the right-hand side near the operator control.
There is also a switch on the optional Remote Control Panel, if installed (Figure 1-4, Item 4).
Pressing any of these switches causes immediate shut down of the system.
Test these switches daily for functionality:
1. Press any of the Emergency Off switches (Figure 1-4, Item 1) and verify that the power is
immediately removed.
2. To reset the system, turn the Emergency Off Switch one-quarter turn to the right to reset it
(Figure 1-4, Item 2), then turn the Circuit Breaker (Figure 1-4, Item 5) off then back on.
3. Repeat this test for all remaining Emergency Off Switches on the system.
Figure 1-4: Location of the Emergency Off Switches and the Circuit Breaker
6 P/N 9-500-0246
Operator’s Manual
Safety
2.6 Interlocks
In addition to the Emergency Off Switches described earlier, the Affinity has several other
safety interlocks.
2.6.1 C-arm Movement Interlocks

Whenever the C-arm encounters an obstruction during travel, this interlock
immediately stops vertical travel and disables downward C-arm vertical movements
until the obstruction is cleared. C-arm movement is also prohibited when
compression force exceeds 50 Newtons (12 lb).
2.6.2 Automatic Compression Release Interlock

Installing a Localization Paddle disables the automatic compression release
functions.
2.6.3 Early Release Interlock

When the X-ray Button is released prior to the end of the exposure, this interlock
immediately terminates the exposure. An alert message is displayed.
2.6.4 Cassette Sense Interlock

This interlock prohibits X-ray exposure whenever the system does not detect a
cassette in the Bucky or optional Magnification Table, or if the cassette is not ejected
after an exposure.
2.6.5 Aperture Interlock

This function detects the installed aperture and image receptor and prohibits X-ray
exposure if it detects an incompatible aperture and image receptor combination.
2.6.6 Mirror and Filter Interlocks

These interlocks prohibit X-ray exposure whenever the Light Field Mirror or the Filter
is not positioned correctly.
2.7 External Indicators

The Affinity contains relay indicators that allow for connections to external indicators to
indicate when the system is on and when X-rays are being taken.
P/N 9-500-0246 7
Operator’s Manual
Compliance
3.0 Compliance
This section describes the mammography system compliance requirements and the
manufacturer’s responsibilities.
3.1 Compliance Requirements

The manufacturer is responsible for the effects of safety, reliability and performance of this
equipment with the following provisions:
1. The electrical installation of the room complies with the appropriate requirements.
2. The equipment is used in accordance with instructions for use.
3. Assembly operations, extensions, re-adjustments, modifications, or repairs are
performed by authorized persons only.
3.2 Compliance Statements

The manufacturer states that this device conforms to:
• Medical Device Directive 93/42/EEC Annex II.
• CAN/CSA ISO 13485:2003/ISO 13485:2003
• IEC 60601-1: Safety Requirements For Medical Electrical Systems
• IEC 60601-1-2: Electromagnetic Compatibility
• IEC 60601-1-3: General Requirements for Radiation Protection
• IEC 60601-1-4: Safety of Programmable Electrical Medical Systems
• IEC 60601-2-7: Safety Of High Voltage Generators
• IEC 60601-2-28: Safety of X-ray Source Assemblies
• IEC 60601-2-32: Safety of Associated Equipment
• IEC 60601-2-45: 2001: Safety of Mammographic Equipment
• FDA, 21 CFR [Parts 820, 900 and 1020]
• UL 2601-1: General Requirements for Safety
• CSA 22.2. No. 601.1: General Requirements for Safety
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Compliance
3.3 Label Locations

Compliance labels and nameplates are positioned appropriately on the Affinity
Mammography system. Nameplates contain the system’s serial number and manufacturing
date.
Figure 1-5: Affinity Labels Locations (Labels not shown to scale)
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Compliance
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Chapter 2—System Controls and Indicators
Affinity System Controls and Indicators
1.0 Affinity System Controls and Indicators

The following controls and indicators are described in this chapter:
Figure 2-1: Affinity System Controls and Indicators
Item Description Described in Section...

1 C-arm Rotation Angle Display Section 3.2, C-Arm Rotation Angle Displays
2 Emergency Off Switch Section 3.4, Emergency Off Switch
3 Control Panel Section 2.0, The Control Panel Controls and Indicators
4 Circuit Breaker Section 3.1, Circuit Breaker
5 X-ray Footswitch Section 3.5, X-ray Exposure Footswitch
6 Footswitches Section 3.3, Footswitch Controls
7 7-Button Keypads Section 7.3, Post Startup Tests
8 AEC Position Lever Section 4.0, Compression Device Controls and Indicators
9 Compression Device Section 4.0, Compression Device Controls and Indicators
10 3-Button Keypad Section 7.3, Post Startup Tests
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The Control Panel Controls and Indicators
2.0 The Control Panel Controls and Indicators

The Control Panel contains an LCD display and a function keypad.

1. LCD Display Screen
2. Function Keypad
3. Scroll Buttons
4. Change Buttons
5. Reset Button
6. Compression Release
Button
7. Exposure Indicator
8. X-ray Button
Figure 2-2: Affinity Control Panel Controls and Indicators
LCD Display Screen (Item 1): Displays system status, alerts, and system settings. The display
is described in detail in Chapter 3—The User Interface.
Function Keypad (Item 2): Contains buttons which scroll through on-screen fields, change
exposure settings, clear alerts, release compression, and initiate an X-ray exposure.
Table 2-1: The Function keypad Buttons and Indicators
Figure 2-2 Button or

Information
Item # Indicator
6 Compression The Compression Release Button releases the compression brake
Release Button and raises the compression device approximately 10 cm.
7 Exposure Indicator The Exposure Indicator is on when the system generates X-rays.
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Gantry Controls and Indicators
Table 2-1: The Function keypad Buttons and Indicators (Continued)
Figure 2-2 Button or

Information
Item # Indicator
8 The X-Ray Button The X-ray Button (and the X-ray Footswitch, if supplied) initiates
the X-ray exposure.
4 Change Keys The left and right arrow Buttons (Change Keys):
• Increase or decrease the values presented.
• Toggle options on or off.
• Cycle through the available choices.
5 Reset Button The Reset Button:
• Alone, it acknowledges and clears an alert message.
• When used with the Up and Down arrows (Scroll keys) it
adjusts the display contrast.
• When used with the Change Keys, it gives access to the User
Default and Exposure Default modes.
3 Scroll Keys The up and down arrow buttons (Scroll Keys):
• Move the focus (highlight) through the fields.
• Adjust the display contrast, when used with the Reset Key.
3.0 Gantry Controls and Indicators

3.1 Circuit Breaker
The Circuit Breaker on the back of the Gantry

functions as the On/Off switch for the system.
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Gantry Controls and Indicators
3.2 C-Arm Rotation Angle Displays

LEDs on each side of the Gantry show the rotation
angle of the C-arm.
3.3 Footswitch Controls

The Footswitch controls motorized C-
arm and Compression Device
movement, freeing the operator’s COMPR
hands during patient positioning. C-AR

M ESSION

1. C-arm Down
2. C-arm Up
3. Compression Down
4. Compression Up
Figure 2-3: The Dual-Function Footswitch
Warning: Always position the Footswitch(es) in such a way as to prevent

accidental activation by patients, operators or wheelchairs.
3.4 Emergency Off Switch

Three Emergency Off Switches are located .
on the Affinity Gantry, two on the front of
the unit (one on each side) and one on the
rear. When the Control Panel is remotely
mounted, an additional Emergency Off
Switch is located on the mounting panel.
Figure 2-4: Emergency Off Switch Operation
3.5 X-ray Exposure Footswitch

If an X-ray Exposure Footswitch is installed on your system, you must press both the X-ray
Footswitch and the X-ray Button on the Control Panel at the same time to make an exposure.
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Compression Device Controls and Indicators
4.0 Compression Device Controls and Indicators

System controls and indicators on the compression device consist of the compression
handwheels, compression device indicators, and the compression paddle sensor.
1 3 5 7 AUTO
7 AUTO
5
3 AEC
1
AEC
CM NEWTONS / LBS
Figure 2-5: Affinity Compression Device Controls and Indicators
Table 2-2: Affinity Compression Device Controls and Indicators
Figure 2-5
Item Description Function
Item #
1 Compression Handwheels (2) Manually raises and lowers compression device.
Compression Thickness Indicator Indicates the compression thickness and
automatically compensates for the image receptor
2 installed.
AEC Sensor Position Indicator Displays the AEC sensor detent position in the
Image Receptor Support Device.
3
Compression Force Indicator This display shows the applied compression force.
4
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The C-arm Keypads
5.0 The C-arm Keypads

The C-arm houses a total of five keypads: four 7-Button Keypads on the sides of the C-arm
(top and bottom), and one 3-Button Keypad at the top of the Tubehead. The two upper 7-
Button Keypads have LEDs to indicate the selected filter (Molybdenum or Rhodium).
Figure 2-6: The C-arm Keypads

1. Filter Type LED Indicators (Mo or Rh)
2. Compression Release Button
3. Compression Up Button
4. C-Arm Up Button
5. C-Arm Rotation Release Button
6. C-Arm Down Button
7. Compression Down Button
8. Light Field Lamp
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Affinity Controls and Functional Tests
6.0 Affinity Controls and Functional Tests

Perform these Functional tests to ensure mechanical integrity.
Item # Function and

Tests
Figure 2-6 Appearance
• Check to see that the Mo filter light is on. (The system default is Moly filter.)
Filter Indicator
• Use the Control Panel to change the filter to Rh. Highlight Filter with the
1 down arrow key, then press the right arrow key to change to the Rh Filter.
• Verify that the Rh light is now on.
• Change the filter back to Moly.
Light Field Lamp • Press and release the Light Field Lamp Button.
2 • Verify the Light Field Lamp illuminates and then turns off after approximately
30 sec.
• Verify the Light Field Lamp illuminates, and the compression device moves
down while the button is held.
Compression Down Button
3
• Verify the compression thickness readout on the compression device
changes accordingly.
• Ensure the compression device stops when the button is released and the
compression brake is active (handwheel-up has resistance).
C-arm down Button • Verify the C-arm moves down while the button is held and it stops when the
4 button is released.
• Verify the C-arm can be rotated while the button is held, and can not be
C-arm Rotation Release
rotated when the button is released.
Button
5 • Verify that when the C-arm rotates, the rotation readouts on the Gantry
change accordingly.
• Verify that the C-arm rotation angle display shows zero degrees of rotation
when the C-arm is in the “CC” position.
C-arm Up Button • Verify the C-arm moves up while the button is held and it stops when the
6 button is released.
Compression Up Button • Verify the compression device moves up while the button is held and the
7 device stops when the button is released.
Compression Release • Press and release the Compression Release Button.

Button on Gantry
• Verify the compression device moves up, stops automatically and the
compression brakes release (handwheel turns easily in both directions).
8
on Function Keypad
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Affinity Controls and Functional Tests
Item # Function and

Tests
Figure 2-6 Appearance
Footswitch Controls • Verify the C-arm Up footswitch moves the C-arm up and it stops when the
footswitch is released.
• Verify the C-arm Down footswitch moves the C-arm down and it stops when
released.
• Verify that the Compression Up and Down footswitches function correctly.
AEC Sensor Position The AEC Indicator on the Compression Device shows the position of the AEC
Sensor. Position 1 is closest to the chest wall.
• Move the AEC sensor handle and ensure the indicator changes.
Emergency Off Switches • Push the switch in. The system immediately shuts down.
• Rotate the switch one-quarter turn right. Toggle the circuit breaker off then
on. The system restarts.
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System Startup Procedures
7.0 System Startup Procedures

Each day prior to clinical use, perform the pre-startup tests, turn the system on and perform
the post startup tests.
7.1 Pre-Startup Tests

Before starting the system, perform the following tests:
1. Ensure all three Emergency Off Switches are reset (four switches if equipped with the
remote control option) by turning them one-quarter turn to the right.
2. Check the overall integrity of the mammography system for open or loose panels,
missing hardware, and signs of damage.
3. Inspect the Operator Radiation Shield for chips, cracks, breaks, and secure attachment.
4. Ensure the room is clear of obstructions.
5. Correct all discrepancies before turning on the system.
7.2 Turning On the System

After completing the pre-startup tests, turn on the Circuit Breaker on the rear of the Gantry
(Section 3.1, p. 13). The back light of the LCD display indicates that power is on. The system
displays a message on the Control Panel indicating that internal tests are being performed.
After successful completion of the internal startup tests, the Run Mode screen appears in the
Display Area of the Control Panel. The system is now ready for use.
Note… If during the internal tests, the system detects a fault condition, a message is
displayed, and startup is suspended until the problem is corrected.
7.3 Post Startup Tests

After the system is turned on, perform the Functional tests, Section 6.0, p. 17, to ensure
mechanical integrity.
8.0 System Shutdown Procedures

1. At the end of each day, turn off the Circuit Breaker to remove power from the
mammography system.
2. Store all of the accessories in a safe place.
3. Perform the daily care, cleaning, and disinfection procedures as described in Chapter
6—Care and Maintenance.
4. Perform a visual check of the system to ensure its integrity.
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System Shutdown Procedures
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Chapter 3—The User Interface
Introduction
1.0 Introduction
Three main screens comprise the Affinity user interface: the Run Mode screen, the User
Defaults screen, and the Exposure Defaults screen.
Table 3-1: Control Panel Display Screens
Run Mode User Defaults Exposure Defaults
Run Mode, the main user screen, is The User Defaults screen changes The Exposure Defaults screen
displayed after startup. compression defaults and other system accesses exposure system defaults.
options.
Reminders… To access the User Defaults or Exposure Defaults screens, press and hold
the Reset Button on the keypad, then press and release one of the Change
Keys (Left/Right Arrows). Use this method to cycle forward and backward
through the three screens.
To select or change values, use the Scroll Keys (Up/Down Arrows) to
highlight the item, then use the Change Keys to make a selection.
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The Run Mode Screen
2.0 The Run Mode Screen

The Run Mode Screen is displayed after startup, and indicates the system is ready for use.
This interface controls the exposure system during clinical procedures and displays messages
about system status.
Figure 3-1: Control Panel in Run Mode

1. Exposure System Displays
2. Message Area
3. Status Area
Note… Some fields are not available for every exposure. The fields enabled depend
on the exposure mode and the installed accessories.
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The Run Mode Screen
2.1 Exposure System Displays

Table 3-2: Exposure System Options in the Run Mode
Field Options Comments

kV 20-35 (Mo) Selected kV or post-exposure kV in Auto-kV or Auto-Filter Modes.
28-39 (Rh)
mAs 3.0 - 500 Selected mAs or post-exposure mAs in Auto Modes.
Maximum selectable mAs is dependent upon kV and Focal Spot.
Mode Manual Manual: Select kV, mAs, Focal Spot, Screen-Film, and Filter.
Auto-kV
Auto-Time: Select kV, Density, Screen-Film, Focal Spot, and Filter.
Auto-Time
Auto-Filter Auto-kV: System automatically selects kV and mAs. The user
selects the Density, Screen-Film, Focal Spot Size, and Filter.
Auto-Filter: Provides full automatic operation of all technique
factors. The user selects Density and Screen-Film.
Density -5 through +5 Available in Auto Modes only, each change in density changes the
exposure mAs from the adjacent density setting based on the
Density Step value (Service-selectable to 6%, 8%, 10%, or 12.5%).
Screen-Film Film 1/2/3 Each film type must be calibrated by an authorized service engineer
before use with AEC modes.
Focus Large/Small 0.3 mm Large Focal Spot or 0.1 mm Small Focal Spot. Not
selectable in Magnification mode. When the focal spot is changed,
the system enters Standby to warm up the selected filament.
Compression Manual/Auto If Auto is selected, compression release occurs immediately after
Release exposure. If a Localization paddle is installed, Automatic
Compression Release is disabled and the Compression Release
field displays LOCKED-OUT.
Filter Mo/Rh System default is Mo. Filter is not selectable in Auto-Filter Mode.
Receptor 24 x 30 cm Displays the Hologic Image Receptor installed.
18 x 24 cm
or Mag
2.2 The Message Area

If the system encounters an alert condition, this area displays the appropriate message and a
numbered code. For a complete list of Affinity alert messages and codes, see Appendix B,
Table B-1 on page 65.
Note… All alert conditions must be corrected before the message can be cleared
using the Reset Key.
2.3 The Status Area

The Status Field shows one of the three operating states of the Affinity:
• STANDBY: The system is not prepared to make an exposure. The system enters this state
under normal conditions (such as allowing the X-ray tube filament to adjust after a focal
spot change, or allowing a brief cool-down period after an exposure), or when an alert
condition exists.
• READY: The Affinity is prepared to make an X-ray.
• X-RAY: This status displays whenever the system is emitting X-rays.
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The User Defaults Screen
3.0 The User Defaults Screen

The User Default screen (Figure 3-2) sets the startup defaults for the compression system,
cassette sense, film ID, force units, date and time. Record the settings for this system on the
worksheet in Appendix Table C-1 on p. 68.
Figure 3-2: The User Default Screen
Table 3-3: Options in the User Defaults Screen
Item Options Comments

Comp Release Manual/Auto If Auto is selected, compression release
occurs immediately after exposure. If a
Localization paddle is installed, Automatic
Compression Release is disabled and the
Compression Release field displays
LOCKED-OUT
FULL Compression 10% - 100% Percentage of compression force applied from
25-40 lb, in increments of 10%.
PRE Compression 10% - 100% Percentage of compression force applied from
15-30 lb, in increments of 10%.
Comp Mode Full/Pre Sets the default compression mode.
Film ID None/Printer/AutoID/Rapid ID Sets the default labeling device.
Force Units Pounds/Newtons Toggles the units of the compression force
display.
Cassette Sense Off/On If enabled, prohibits exposure if film is already
exposed or if a cassette is not inserted.
Date mm/dd/yyyy Sets the system date. Highlight the
dd.mm.yyyy placeholder between fields (forward slash or a
dot) and press a Change Key to toggle
between US and International date formats.
Time hh:mm AM/PM (12H) Sets the system time. Highlight the 12H or
hh:mm (24H) 24H field and press a Change Key to toggle
between 12-hour and 24-hour formats.
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The Exposure Defaults Screen
4.0 The Exposure Defaults Screen

This screen sets exposure system defaults for each exposure mode. The selections made here
are displayed on the Run Mode screen each time the system starts up.
4.1 An Overview of the Exposure Defaults Screen

The Exposure Defaults screen has two sections: the upper portion sets defaults for each
exposure mode, while the lower portion controls which mode to display at startup. To use
this screen:
1. Set the parameters for each exposure mode.
2. Choose a default exposure mode for normal and one for magnification procedures.
Figure 3-3: Overview of the Exposure Defaults Screen
3. Record the settings for this system on the worksheets in Table C-2, “Selected Exposure
Technique Defaults,” on p. 69 and Table C-3, “Selected Magnification Device Exposure
Technique Defaults,” on p. 70.
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4.2 Setting Defaults for Each Exposure Mode
Note… For ease of explanation, inaccessible fields are shown in light gray in the
following screen illustrations. All fields are the same color on the actual
screens.
4.2.1 Auto-Filter Mode
Table 3-4: Auto-Filter Mode Options
Item Options
Starting kV 25 or 26
Density -5 through +5
Screen-Film Film1/2/3
Auto-kV Window 200 mAs, Auto
Figure 3-4: The Auto-Filter Mode Defaults
4.2.2 Auto-kV Mode
Table 3-5: Auto-kV Mode Options
Item Options
Focus Large/Small
Auto-kV Window LG FS: 200/165/125/Auto
SM FS: 60/50/38/Auto
Figure 3-5: The Auto-kV Mode Defaults
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4.2.3 Auto-Time Mode
Table 3-6: Auto-Time Mode Options
Item Options
kV 20-35 (Moly), 28-39 (RH)
Focus Large/Small
Figure 3-6: The Auto Time Mode Defaults Screen
4.2.4 Manual Mode
Table 3-7: Manual Mode Options
Item Options
kV 20-35 (Moly), 28-39 (RH)
mAs 3-500 LG FS
3-150 SM FS
Focus Large/Small
Figure 3-7: The Manual Mode Defaults Screen
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4.2.5 Mag Auto-kV Mode
Table 3-8: Mag Auto-kV Mode Options
Item Options
Auto-kV Window 60/50/38/Auto
Figure 3-8: The Auto-kV Mode Defaults Screen
4.2.6 Mag Auto-Time Mode
Table 3-9: Mag Auto-Time Mode Options
Item Options
kV 20-35 (Moly), 28-39 (RH)
Figure 3-9: The Mag Auto-Time Mode Defaults Screen
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4.2.7 Mag Manual Mode
Table 3-10: Mag Manual Mode Options
Item Options
kV 20-35 (Moly), 28-39 (RH)
mAs 3-150
Figure 3-10: The Mag Manual Mode Defaults Screen
4.3 Setting the Default Exposure Modes
EXPOSURE DEFAULTS
MODE : MANUAL
kV : 25 Table 3-11: Default Exposure Modes
mAs : 100
Density : ----- Item Options
Screen-Film : ----- Default Exposure Mode Manual
Focus : LARGE Auto-kV
Auto kV Win : ----- Auto-Time
Def Exp Mode : MANUAL Auto-Filter
Def MAG Mode : MANUAL
Default Mag Mode Mag Manual
Mag Auto-kV
Mag Auto-Time
SETUP
Figure 3-11: Exposure Defaults Setup Screen
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Chapter 4—Accessories
Introduction
1.0 Introduction
You can configure the system to perform screening and diagnostic applications, using exam-
specific accessories. This chapter describes the use of the accessories, accessory installation,
set up and removal. Note that the accessories installed depends on the option package
purchased with your system, and the type of clinical application. For a list of available
accessories for the Affinity, see Table C-4, “List of Available Accessories,” on p. 71.
2.0 The Patient Face Shield

The Face Shield prevents the patient’s head and face from entering the X-ray field during the
examination. The Face Shield mounts to the tubehead and surrounds the X-ray tube port.
To install the Face Shield:
1. Position the Face Shield so that its open side faces the C-arm.
2. Slide the open end of the Face Shield into the slots on the tubehead mount.
To remove, pull the rear sides of the Face Shield out (away from the tubehead), then slide the
shield off the mount.
Figure 4-1: Installing the Face Shield
Warning: For exposure other than magnification studies, always ensure that
the Face Shield is attached. Remember to check its condition prior
to use each day. The Face Shield does not offer protection from
exposure through the acrylic.
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Bucky Devices
3.0 Bucky Devices

The Bucky devices accept DIN-style cassettes only. These cassettes have a sliding window for
photographic placement of exposure information directly onto the film using the optional
AutoFilm I.D.
Note… Due to the non-standardization of DIN cassettes, some cassettes may move
slightly as the C-arm is rotated.
1
2
1
2
Figure 4-2: Mounting and Loading the Bucky Device
3.1 Installing and Removing the Bucky Device

To install and load the Bucky device (see Figure 4-2):
1. Stand in front of the system, facing the C-arm. Orient the Bucky so that the Bucky
connector is facing the receptacle on the C-arm.
2. Align the slide rails on the bottom of the Bucky with the edges of the Image Receptor
Support Device (IRSD).
3. Slide the Bucky onto the IRSD until its connector is secured into the receptacle on the C-
arm and the Bucky latches engage.
4. To remove the Bucky device, pull the Bucky release lever, #2, (right side of Bucky)
towards you.
5. Slide the Bucky straight off the IRSD.
Note… The top surface of the Bucky has two indicator lights (green and amber) to
indicate the presence or absence of a cassette, and to indicate exposure status.
GREEN—Ready status: The cassette is installed and ready for exposure.
AMBER—Standby status: Change the cassette (post-exposure), or the
cassette is not installed.
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Bucky Devices
3.2 Loading and Unloading the Bucky Device

To load the Bucky device, insert a loaded cassette from either side—until it locks into place.
To eject a cassette from the Bucky, push a cassette eject lever, #1, (one on either side of the
Bucky) to eject the cassette from that side, and pull the cassette straight out of the Bucky.
3.3 Integrated Bucky Markers

3.3.1 Using the Markers
To select an individual marker:
1. Slide down the
smaller metal
button on the left
or right marker set,
exposing the set of
labeled markers.
2. Select one of the 4
options by rotating
the wheel
counterclockwise
until the needed
identifier is within
the image field.
Figure 4-3: Placement of the Bucky Markers

1. Marker buttons
2. Adjustment knobs
3.3.2 Positioning the Markers

The adjustment knob can be loosened to move the entire marker housing so that you
can slide the markers as a whole along the upper portion of the Bucky so they are
located on each side furthest from the patient. Tighten the adjustment knob to secure
the markers in place.
3.3.3 Aligning the Markers

Align the left set of markers to run parallel to the white cassette indicator line on the
Bucky. The housing should be placed so that none of the housing is in the image. If
it is in the primary beam, unscrew the adjustment knob and move the housing back
away from the chest wall edge of the Bucky. Once the ideal placement has been
found, tighten the adjustment knob to secure the marker in place.
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Cassette Holder and Magnification Platform
The right set of markers should be placed so that the markers clear the lead blocker
intended for patient information. Once the placement is set, tighten the adjustment
knob to secure the marker in place.
3.3.4 Removing and Replacing the Markers

Completely unscrew the adjustment knob and slide the markers and the housing off
of the rail.
To replace, align the housing with the rail and slide up back into the track. Replace
the knob and tighten down.
4.0 Cassette Holder and Magnification Platform

The 18 x 24 cm front loading cassette holder is optional on the Affinity system. This cassette
holder accepts both daylight loading cassettes and non-daylight loading cassettes. Typically,
the cassette holder is only installed during magnification studies when the Magnification
Platform is installed.
4.1 Installing and Loading the Cassette Holder for Magnification Studies
1. Remove the Face Shield.
2. Raise the Compression Device above the slots in the C-arm. This provides the space
needed to safely install the Magnification Tray.
3. Remove the Bucky device.
4. Align the slide rails on the bottom of the 18 x 24 cm cassette holder with the edges of the
IRSD. Slide the cassette holder onto the IRSD until it stops.
5. Orient the loaded cassette so that it is directly over the cassette holder. Tilt the tube side
edge of the cassette down, then slip it under the front lip of the cassette holder.
6. Push down on the chest wall edge of the cassette until it snaps securely into the cassette
holder.
Figure 4-4: Mounting and Loading a Cassette Holder
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Cassette Holder and Magnification Platform
4.2 Installing the Magnification Platform

The Affinity Magnification Platform is installed on the Affinity C-arm and consists of a breast
platform and an abdominal shield.
1. Hold the Magnification Platform by the support brackets and orient it in front of the
C-arm so that the hooks align with the mounting slots.
2. Slip the hooks into the C-arm slots.
3. Push it down until the clips lock it in place.
4.3 Removing the Magnification Platform

1. To remove the Magnification Platform, press down on the locking clips to release the
hooks.
2. Lift the accessory up and out by the support bracket.
Figure 4-5: Magnification Platform Installation
4.4 Removing the Cassette and Cassette Holder

1. To remove the cassette from the cassette holder, firmly hold both sides of the cassette
near the chest wall edge.
2. Pull up until the chest wall end of the cassette disengages from the cassette holder.
3. Pull the cassette holder off the IRSD.
4. Replace the Bucky device.
5. Replace the Face Shield.
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Magnification Table
5.0 Magnification Table

The Magnification Table is complete with a built-in image receptor holder which is
equivalent to a side-loading cassette holder. The Platform slides onto the IRSD in the same
manner as the Bucky device.
The base of the Magnification Table has two indicator lights (green and amber) to indicate
the presence or absence of a cassette, and to indicate exposure status. Exposures are not
prohibited if the amber light is on.
• GREEN—Ready status: The cassette is installed and ready for exposure.
• AMBER—Standby status: Change the cassette (post-exposure), or the cassette is not
installed.
Note… Installing a Magnification Device automatically causes the system to

change to the Default MAG mode.
Note… As soon as the exposure has been made (indicated by a change from Green
to Amber light), remove the cassette from the Bucky device and keep it
separate from unexposed film.
Figure 4-6: Magnification Table
5.1 Installing the Magnification Table

1. Raise the Compression Device above the slots in the C-arm to provide space to install
the Magnification Table.
2. Remove any Bucky device.
3. Align the slide rails of the Table with the edges of the IRSD. Slide the Magnification Table
onto the IRSD until it snaps into place.
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Magnification Table
5.2 Loading the Table

Slide the loaded cassette into the Magnification Table cassette slot from either side until it
snaps into place.
5.3 Removing a Cassette

1. Push the Cassette Eject lever on either side of the Magnification Table until the cassette
slips out of the cassette slot. See Figure 4-2, p. 32.
2. Pull the cassette straight out of the device.
5.4 Removing the Table

The Magnification Table removal from the IRSD is the same as a Bucky. See Figure 4-2, p. 32.
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Compression Paddles
6.0 Compression Paddles

The 18 x 24 cm Standard Compression Paddle is used for full field contact imaging. Other
paddles, supplied as options, permit the system to perform applications such as:
• Supplemental View Exams
• Needle Localization
• Spot Compression Studies
• Spot Magnification Studies
• Small Breast Screening
Refer to the following illustration and table as a guide in selecting Compression Paddles.
Figure 4-7: Affinity Compression Paddles
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Compression Paddles
Table 4-1: Compression Paddle Applications
Number Compression Paddle Typical Application

1 10 cm Contact/Magnification Supplemental Views (for example, axillary or
quadrant)
2 15 cm Contact/Magnification Supplemental Views (for example, axillary or
quadrant)
3 15 cm (Open or Perforated) Localization
4 10 cm (Open or Perforated) Localization
5 24 x 30 cm Standard Routine Screening
24 x 30 cm FAST
6 18 x 24 cm Standard Routine Screening
18 x 24 cm FAST
7 Ultrasound Ultrasound
8 7.5 cm Spot Contact/ Spot Compression and Spot Magnification Studies
Magnification
9 Small Breast Small Breast Screening
6.1 AEC Sensor Markings—Full Field Compression Paddles

The surfaces of the Full Field Compression Paddles are marked with the 7 locations of the
AEC sensor to help the user accurately position the AEC sensor during automatic exposure
mode.
6.2 FAST Paddle Use

Use the Fully Automatic Self-adjusting Tilt (FAST) paddle for patients with breast tissue
compositions that do not permit uniform compression across the entire breast when using
the conventional flat compression paddles. For these patients, inadequate compression
across the entire breast area results in an image that might appear to be “out of focus,” or
“fuzzy,” in the anterior region. This is due to both involuntary motion as well as inadequate
compression of overlapping tissue.
For those patients with a disproportionate thickness at the chest wall compared to the
anterior area of the breast, the FAST paddle provides the following benefits:
• Reduced motion artifacts due to better immobilization
• More uniform compression from the chest wall to the nipple for superior image quality
• Maximum patient comfort by preventing over compression at the chest wall
The FAST Paddle is designed to automatically tilt as compression is applied. The paddle is in
a flat position until a compression force of approximately 20 pounds (88 Newtons) is
applied, then it proceeds to tilt to its maximum angle at an applied force of approximately 30
pounds (132 Newtons) or greater. It is very important to apply sufficient compression to
immobilize the breast, however, the use of the FAST Paddle does not require excessive
compression for superior image quality.
For operation with the HTC Bucky, proper compression is necessary when using the FAST Paddle.
It is very important to be consistent in the application of compression using the FAST Paddle. This
is particularly true for corresponding right and left views as this improves image quality.
The FAST Paddle may not be ideal for breasts that are equal or symmetrical in thickness from
the chest wall to the anterior area of the breast.
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Compression Paddles
6.3 Installing and Removing Compression Paddles
Note… When a Localization Paddle is installed, the system turns off the automatic
Compression Release features, and disables the Compression Release
Buttons. Patient release is available through the Compression Up functions
(buttons or footswitch).
All Compression Paddles are mounted to the Compression Device in the same manner.
1. Align the mounting pins on the rear paddle frame with the mounting holes in the
Compression Device.
2. Push the Compression Paddle firmly into the Compression Device until it stops.
3. Gently pull the paddle out approximately 1/8" until you feel it click into place.
4. To remove the Compression Paddle, grasp the metal paddle frame with both hands, then
pull it straight out of the mounting holes.
Figure 4-8: Installing Compression Paddles
Caution: Removing the compression paddle by grasping the plastic may cause
damage to the plastic.
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Compression Paddles
6.4 Realigning the Paddle Front Edge

Always ensure the paddle front edge is parallel to and flush with the Image Receptor.
To confirm the edge alignment:
1. Install the paddle and apply 30 lb (132 N) of compression force.
2. Ensure that the front edge is parallel to and flush with the Image Receptor.
Figure 4-9: Paddle Alignment
To re-align the edge when it is not aligned as shown:

1. Release the compression and remove the paddle.
2. If the paddle is a standard screening paddle, or a frameless spot paddle, turn the paddle
upside down and loosen, one full turn, the hardware holding the Lexan paddle to the
frame.
3. Turn the paddle right side up (if necessary) and loosen the two inside screws.
Figure 4-10: Paddle Alignment Adjustment Screws
4. Install the paddle and reapply 30 lb (132 N) of compression force.

5. Move the paddle to the optimum position. (Do not release the compression.)
6. Re-tighten both inside screws. See Figure 4-10.
7. Release the compression and remove the paddle.
8. If this is a standard screening or frameless spot paddle, turn it upside down and retighten
the hardware that secures the Lexan paddle to the frame.
9. Reconfirm the paddle position by installing it and applying 30 lb (132 N) of compression
force to see if it is still aligned correctly.
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Apertures
7.0 Apertures
Apertures are used to collimate the X-ray field to an appropriate size for the clinical
application being performed. The Affinity automatically detects the type of aperture
installed. If the system detects an aperture that is not compatible with the image receptor, the
system remains in a “standby” condition and prohibits exposures.
Figure 4-11: Affinity Apertures
7.1 Available Apertures

1. Auto-Aperture-18 x 24 cm; 24 x 30 cm
2. 7.5 cm Spot Contact
3. 10 cm Coned Contact
4. 7.5 cm Spot Magnification
5. Magnification Full Field
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Apertures
7.2 Installing and Removing Apertures

1. Align the selected aperture with the front of the tubehead slot. Orient it so that the
faceplate is facing away from the tubehead.
2. Insert the aperture completely into the slot until the plastic faceplate is flush with the
tubehead housing.
3. To remove the aperture, pull it straight out of the tubehead slot by the faceplate.
Figure 4-12: Installing Apertures
Caution: Always use care when handling apertures to prevent damage to the
assembly. Always store apertures in a safe location when they are not in
use. A mishandled aperture (for example, dropped, crushed) must be
checked by a authorized service engineer to ensure that it complies with
regulations.
7.3 Aperture Compatibility

For information about compatible aperture, paddle and IRSD combinations, see Table C-5,
“Aperture Compatibility,” on p. 72.
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Crosshair Device (optional)
8.0 Crosshair Device (optional)

8.1 Installing and Removing the Crosshair Device
To install the Crosshair device:
1. Remove the face shield from the
face shield rails.
2. Move the compression device
below the C-arm mounting slots.
3. Hold the Crosshair device by the
support brackets and slip the
hooks into the C-arm slots.
4. Push down to lock.
5. Mount the localization paddle on
the compression device. Figure 4-13: Installing the Loc Crosshair
To remove the Loc Crosshair device:

1. Flip the crosshair device to either side for ease of removal.
2. Press on the two locking levers inside each mounting arm. See Figure 4-14, #1.
3. Lift the frame upward and out.
8.2 Aligning the Loc Crosshair Device to the Localization Paddle
Note… Before performing the following adjustment, ensure the localization paddle
is adjusted properly with respect to the edge of the image receptor, see
Figure 4-9, p. 41.
1. Install the rectangular localization

paddle.
2. Loosen the adjustment lock screw
located on the bottom of the Loc
Crosshair device, Figure 4-14, #2.
3. Place a piece of white paper on the
breast tray to make it easier to see the
shadows of the crosshairs.
4. Raise the localization paddle about 6
cm above the image receptor.
5. Turn on the light field.
6. Move the Loc Crosshair device until the
rectangle of light aligns with the
opening in the localization paddle.
7. Tighten the adjustment screw. Figure 4-14: Adjustment Lock Screw and
Latch
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Dual-Function Footswitch(es)
9.0 Dual-Function Footswitch(es)

The Affinity provides receptacles for connecting
two Dual-Function Footswitches. Each
Footswitch enables motorized, hands-free up
and down movement of the C-arm and the
Compression Device, that is identical to the
corresponding movements provided by the push-
button controls on the C-arm Keypads.
Figure 4-15: Footswitch Receptacle
Typically, an authorized service engineer connects the Footswitch(es) at the time of

installation. If you need to install the Footswitch(es) at other times:
1. Orient the notch in the Footswitch connector with the notch in the Footswitch receptacle
on the rear of the Gantry.
2. Plug the Footswitch connector into the Footswitch receptacle.
3. Position the Footswitch Assembly in the desired location on the floor below the C-arm. If
the system has two Footswitches, position them so that one is accessible from each side
of the C-arm.
4. To detach the Footswitch, hold the Footswitch connector firmly as you pull it straight out
of the receptacle.
Caution: Never detach the Footswitch by pulling on its cord.
Warning: When examining a patient in a wheelchair, place the footswitch so as

to prevent accidental activation by the patient or chair.
COMPR
M ES SION
C-AR
Figure 4-16: The Dual-Function Footswitch
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Dual-Function Footswitch(es)
46 P/N 9-500-0246
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Chapter 5—Clinical Procedures
Introduction
1.0 Introduction
The Affinity is capable of performing routine screening, diagnostic studies, magnification
studies, and localization procedures. Each of these procedures requires a different
combination of accessories, but all are performed in the same general sequence of steps.
This chapter provides a suggested sequence of operation to take patient films with the
Affinity. It should be noted that these steps are a recommended route of proceeding through
the examination process, and that they are not intended as substitutes for conventional
clinical training and methodology.
2.0 System Startup

Before the patient is brought into the exam room, perform the power-up tests to be sure the
system is turned on, and that it is functioning properly. See Chapter 2, Section 6.0, p. 17.
Also, a startup procedure checklist is available in Appendix C, System Startup and Clinical
Procedure Checklist, p. 67.
3.0 Installation of Accessories

Install the appropriate accessory for the procedure:
• Image Receptor
• Compression Paddle
• Aperture
• Face Shield
• Crosshair
4.0 Settings—Exposure Techniques

For new patient exams, set the exposure techniques for the first view before placing the
patient under compression. The exposure techniques set will depend on the exposure mode
selected. Use the following as a guide:
1. For Manual mode exposures, set the kV, mAs, screen-film type, Focal Spot and filter.
2. For Auto-Time mode exposures, set the kV, Focal Spot, screen-film type, Density and
filter.
3. For Auto-kV mode exposures, set the Focal Spot, screen-film type, Density and filter.
4. For Auto-Filter mode exposures, set Density and screen-film type, if necessary.
5.0 Positioning the Patient

1. Use the C-arm height controls to raise or lower the breast platform to accommodate
each patient.
2. Use the C-arm rotation release controls to move the tubehead to the required clinical
projection angle. Displays on the Gantry show the current rotation angle of the C-arm.
3. Move the patient up to the C-arm.
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Exposure Sequence
4. Make final height adjustments to bring the breast platform to the same plane as the
patient’s breast.
5. Place the patient’s breast under compression.
• Whenever possible, use the footswitch controls to provide hands-free compression
control and C-arm height adjustment.
• Use the Light Field Lamp as necessary to visualize the X-ray field. Position the
patient’s breast within the illuminated field to ensure total coverage.
6. Place the patient’s arm or hand on the patient handle. Inform the patient of the locations
of all push button controls and give instructions to avoid contact with any of these
system controls.
7. During motorized compression, pay attention to smooth any skin folds. Use positioning
techniques to maximize chest wall imaging.
8. Apply compression slowly. As necessary, stop and make positioning adjustments. Use
the Handwheels to make final compression adjustments.
Warning! Always pay particular attention to the position of the patient’s

hands and arms relative to any of the C-arm controls.
6.0 Exposure Sequence

Once the patient’s breast is compressed, make the exposure. Consider using this suggested
sequence for making mammographic exposures using the Affinity:
Warning: Observe all safety precautions when making X-ray exposures.
1. For automatic exposure mode, position the AEC sensor beneath the densest portion of
the breast.
2. Step behind the Operator Radiation Shield, and check that all exposure factors are set as
desired. If necessary, make any final technique changes.
3. Verify that the status area on the Run Mode screen reads: READY. If the system does not
enter a “ready” status within 20 seconds, verify that all the necessary accessories are
installed and are compatible with the type of exam being conducted. Refer to Appendix
C, Aperture Compatibility, p. 72 if necessary.
4. Press and hold the X-ray Button and footswitch (if installed) for the entire exposure
duration—until the tone stops.
5. If the compression release method is set to manual, raise the compression device, then
assist the patient away from the C-arm. If the automatic release feature is set, the
compression device raises after the exposure.
6. Verify that the Run Mode Status field indicates: STANDBY. Check that after 30 seconds
the system status returns to READY.
7. Evaluate the post-exposure mAs value (automatic modes) for subsequent technique
adjustments.
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Magnification, and Localization Procedures
7.0 Magnification, and Localization Procedures

7.1 Magnification Procedure
1. Install the Magnification Table or Platform.
2. Install the appropriate Magnification paddle.
3. Ensure:
• The Mode reads MAG
• The receptor reads MAG
• the Focal Spot reads SMALL
• The correct aperture is installed and the light field only illuminates the correct area.
7.2 Localization Procedure

1. Change the Compression Release setting to Manual if set on automatic
2. Install the Crosshair device.
3. Install the Localization paddle.
Note… The Crosshair device can be moved out of the beam path, when not in use,
by rotating it in either direction. It locks into place when the device is
centered in the beam path.
4. Rotate the Crosshair device out of the field before taking the scout image.
5. Take the scout image using AEC or appropriate exposure mode.
Note… Locked-out mode, in effect with a localization paddle, automatically

disables the compression release function. Use compression Up buttons for
release.
6. Develop the film
7. Locate the horizontal and vertical lesion position on the film.
8. Move the crosshair device back into the field.
9. Turn on the light field lamp
10. Adjust the crosshair knobs to place the crosshair shadows at the appropriate reference
labels on the localization paddle. The intersection of the crosshair shadows on the skin
indicates the position of the lesion on the scout image.
11. Mark the lesion position on the skin.
12. Move the crosshairs out the field before continuing.
13. Continue with the Localization procedure, changing paddles as required.
14. Upon completion of the procedure, change the compression release back to automatic if
this is the site default.
15. Remove the Crosshair device from the C-arm.
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Labeling the Film (Option)
8.0 Labeling the Film (Option)

The Affinity system has two film labeling option types. The AutoFilm I.D. and Rapid ID place
a photographic label of patient and exposure factors directly onto the film.
For systems equipped with the AutoFilm I.D. or Rapid ID, use their keyboard to enter the
patient data.
1. Remove the cassette from the Image Receptor at the end of the exposure.
2. Slip the DIN-style cassette into the ID slot.
3. When the tone stops, pull the cassette out, then process the film. The processed film will
show the “flashed” label in the upper corner of the film.
A label printer port is provided for optional hardcopy labels.
Note… When the exam is complete, perform the care, cleaning, and disinfection
procedures described in Chapter 6—Care and Maintenance, before using
the system on another patient.
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Chapter 6—Care and Maintenance
Care and Cleaning
1.0 Care and Cleaning

Handle the plastic accessories carefully, and inspect them frequently. If they should begin to
crack, discontinue their use and replace them.
1.1 Cleaning and Disinfection

All parts of the system which come in contact with the patient must be cleaned and
disinfected prior to each examination.
The standard hospital regimen for disinfection should be followed, with the following
qualifications:
• Do not clean with solvent-based cleaners (containing benzene, or stain removers)
surfaces on parts which contact the patient (for example, Face Shield, cassette holders,
Bucky devices, compression paddles).
• Do not use extra strength or abrasive cleaners, polishes, or waxes on parts which contact
the patient.
Proprietary disinfection solutions meeting the above limitations are suitable, provided that
the manufacturer’s instructions are stringently followed.
As a general rule, disinfectant sprays may not be used directly, since the mist generated by
spraying may penetrate into the system, which may damage electronic components. To use a
disinfectant agent in spray form, first apply the agent to a sterile cloth or pad, and then use
the pad to apply the agent to the surface requiring disinfection.
1.2 Recommendations
For general cleaning, use a lint-free cloth dampened with water, or a lukewarm, diluted
aqueous solution of household dishwashing liquid.
The following cleaning solutions have been found to be compatible with polycarbonate
compression paddles and accessories:
• 10% chlorine bleach & water solution
• 70% (by volume) isopropyl solution
• 90% maximum concentration of Hydrogen Peroxide solution
Note… After cleaning with the above solutions, the paddles must be washed with
soap and warm water.
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Maintenance Schedule
2.0 Maintenance Schedule

The following section outlines a maintenance regimen which, if followed, will help to
maintain peak performance of the Affinity Mammography System.
2.1 Daily Maintenance Schedule

1. Perform the standard hospital regimen for cleaning and disinfecting all parts that come
in contact with the patient, prior to each examination.
2. Use a lint-free cloth dampened with water, or a lukewarm, diluted aqueous solution of
household dishwashing liquid to wipe the system at the end of the day.
2.2 Monthly Maintenance Schedule

1. Perform complete functional tests of the system’s electro-mechanical systems. Correct all
discrepancies as they are encountered.
2. Inspect all accessories for damage, even those that are not commonly used. Replace
damaged accessories immediately.
2.3 Semi-Annual Maintenance

• Compression
• Timer Accuracy and Reproducibility
• kVp Accuracy and Reproducibility
• mR/mAs Linearity
• HVL
2.4 Annual Maintenance

• Assembly Evaluation
• Collimation
• Focal Spot Size
• AEC Performance
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Appendix A—Specifications
System Requirements and Dimensions
1.0 System Requirements and Dimensions

1.1 Electrical Input
Mains Voltage 200 VAC, 208 VAC, 220 VAC, 230 VAC, or 240 VAC
nominal (±10% tap selectable at installation), 50 or 60
Hz, 1 phase with separate neutral and ground,
permanently connected
Mains Impedance Maximum line impedance not to exceed 0.20 Ohms for
200 VAC input voltage, and 0.25 Ohms for all other
specified input voltages
Max. Power Consumption 7.75 kVA for 5 seconds duration
Standby Current 0.5 kVA nominal
Maximum Line Current 35 Amps for 5 seconds
Circuit Breaker Rating 20 Amps. Time delay curve allows for inrush currents
(200% overload for 7 seconds).
Maximum Cycle Rate Full load 5 seconds on; 20 +1.5 seconds off
1.2 Operating Environment

Temperature Range 10° C to 40° C (50° F to 104° F), IEC 60601-1
Relative Humidity Range 30% to 75% non-condensing, IEC 60601-1
ESD Susceptibility Level of 3 kV for contact discharge to conductive
accessible parts that are not grounded. A level of 8 kV
for air discharge to all accessible parts. IEC 60601-1-2
EMI Susceptibility System is immune from levels of 1 v/m for the frequency
range of 26 MHz to 1 GHz. IEC 60601-1-2
EMI Generation Limits System complies with the requirements of IEC 60601-1-
2 for conducted and radiated emission.
Input Line Surge, fast transient/burst, lightning, IEC 60601-1-2
Maximum Heat Dissipation 1700 Btu/Hour in stand-by
1.3 Storage Environment

Temperature Range -25° C to +60° C (-13° F to +140° F). Requires labeling
on shipping container.
Humidity Zero to 95% humidity (non-condensing); not packaged
for outdoor storage.
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System Requirements and Dimensions
1.4 Room Requirements

The exam room containing the Affinity mammography system must meet all local, state, and
federal requirements for conducting X-ray examinations. In addition, the exam room should
provide:
• Ample space for patient, operator, and C-arm maneuvering
• Accessory storage area
• Adequate ventilation and cooling for both equipment and occupants
1.5 System Dimensions

Height 178 cm ±2 cm (70 inches)
Width 67 cm ±2 cm (26.4 inches)
Depth 109 cm ±2 cm (43 inches) including C-arm
Weight 267.2 kg ±10 kg (588 lb)
Radiation Shield 185 cm x 60 cm (73 inches x 24 inches) provides
minimum of 0.5 mm of lead attenuation at 35 kV
Figure A-1: System Dimensions
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C-arm, Compression, and IRSD
2.0 C-arm, Compression, and IRSD

2.1 C-arm
C-arm Rotation Manual; ccw (+) 195° to 205°, cw (-) 145° to 155°;
detents at every 45°
Rotation Lock Electromagnetic, fail-safe
Vertical Travel (minimum) 71 to 140 cm (28 to 55 inches) from Bucky surface to
floor for C-arm at 0°
Alignment—Focal Spot, Compression Device and Image Receptor
The focal spot of the X-ray tube is located such that the
ray falling on the edge of the image receptor closest to
the chest wall is perpendicular to the image receptor.
The system allows the plane formed by the focal spot
and the chest wall of the device to be perpendicular to
that ray, and the motion of the compression device
provides essentially parallel compression of the breast
with respect to the plane of the image receptor.
Source to Image Distance (SID) 64.6 cm ±0.5 cm from the nominal position of the large
focal spot to the image receptor (film) located in the
Bucky
C-arm Functions Vertical drive, rotation, compression function,
compression release, light field, etc., are simultaneously
operable. Compression up and down is also controlled
by footswitches.
2.2 Compression
Manual Compression Force Limited to a maximum 300 N, +0/-88 N (67.4 lb, +0/-20
lb) between -150° through 0° to +150° of C-arm
rotation. It is not less than 150 N (33.7 lb) at all other
angles.
Motorized Compression Force User Selectable for either Full or Pre Compression
modes in User Defaults. 66 N to 178 N (15 lb to 40 lb),
user-selected within this range. Factory default of 132 N
(30 lb).
Full Compression User adjustable with a nominal range of 111 N
minimum to 178 N maximum (25 lbs minimum to 40
lbs maximum).
Pre Compression User adjustable with a nominal range of 66 N minimum
to 132 N maximum (15lbs minimum to 30 lbs
maximum).
Motorized Compression Motorized Up/Down controls on both sides of the C-
arm and on the dual function footswitch.
Manual Release Manual Up/Down handwheel controls on both sides of
the Compression Device.
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C-arm, Compression, and IRSD
Compression Release Motorized release controlled by push buttons on both

sides of the C-arm and on the Control Panel. Automatic
release of the compression device can be enabled by
the user through software, which releases the
compression device at the end of the X-ray exposure.
All compression release functions are disabled when a
localization paddle is installed. Release is motor driven.
Automatic Compression Release Moves the compression device a distance of 10 cm +1
cm and is limited to 3.0 +1.0 seconds of travel duration
when the available travel is less than 10 cm.
Compression Force Display LED on Compression Device Cover shows the
compression force in increments of 4.5 N (1 lb),
rounded to the nearest integer.
Back Drive After Compression Does not exceed 1.5 mm in either motorized or manual
drive modes between -90°, 0, and +90°, and no greater
than 3 mm at all other positions.
C-arm Movement C-arm movement is locked out when greater than 50 N
(12 lb) of compression force is applied.
Compression Thickness Measurement and Display
Thickness is measured between 0 and 15 cm above the
breast support. The Display compensates for the type of
Image Receptor installed. The compression display is
angled and visible from both sides of patient.
Compression Thickness Accuracy ±0.5 cm between 0.5 cm and 15 cm at 132 N (30 lb)
compression force. The measurement is reproducible
within +2 mm of the displayed value. Compression
thickness is displayed on the compression device and is
angled and visible from both sides of patient.
2.3 Image Receptor Support Device

Image Receptor Support Device Contains sensors for accessory detection and a 3-cell
automatic exposure control detector, movable to seven
positions in 1.7 cm increments. The Image Receptor
Support Device limits X-ray transmission to less than 0.1
mR for the maximum exposure. Complies with 21 CFR,
section 1020.31, and meets the 1 mGy per exposure as
defined by IEC 60601-1-3, section 29.207.2.
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X-ray System
3.0 X-ray System

3.1 Automatic Exposure Control
AEC Detector Configured with three 1 cm square sensors configured
in a “D” shaped pattern with the center sensor 8 mm
forward of the outer two.
Detector Positioning The detector is centered laterally in the IRSD and may
be moved forward or rearward to one of 7 detent
locations. Position #1 is 1.5 cm from the chest wall,
increments at 1.7 cm intervals from position #1. Total
movement of 10.2 cm.
AEC Detector Position Indication The detent position of the sensor is displayed on the
corresponding LED (7 LEDs) on the AEC Position
Indicator on the upper compression device cover.
kV and Thickness Tracking AEC compensates for kV between 20 kV and 39 kV, and
for breast thickness between 2 cm and 6 cm (at
appropriate clinical kV) to produce optical densities
within 0.15 OD from the mean Optical Density.
Exposure Termination The AEC system can determine if the exposure will
reach the back-up-time in which case the exposure is
terminated within one of the following limits:
55 max milliseconds (maximum of 110 ms when in
Auto-kV or Auto-Filter modes)
5.25 max mAs (maximum of 10.5 mAs when in Auto-kV
or Auto-Filter modes)
An entrance exposure to the ACR MAP phantom of less
than 60 mR (160 mR when in Auto-kV or Auto-Filter
modes)
Indication is made to the operator, and a manual reset is
required to continue the exam.
Density Adjustment Steps The 11 density adjustment steps -5 to +5 in adjustable
steps of 6%, 8%, 10%, or 12.5% (Tolerance ±5%,
Factory default at 10%) provide a difference in mAs
from the adjacent step. These are field selectable at
installation.
3.1.1 AEC Mode Operating Range
Table A-1: AEC Mode Operating Ranges
Mode kV mAs
Auto-Time 20 to 39 kV 5 to 500 mAs
Auto-kV 25 to 30 kV 5 to 500 mAs
Auto-Filter 25 to 32 kV 5 to 500 mAs
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X-ray System
3.2 HV Generator (in compliance with IEC 60601-2-7)

Output Rating 3.2 kilowatt isowatt, minimum (100 mA @ 32 kV) at all
loading times.
Ripple Typically no greater than 2% with a maximum of 4% at
lower output loads (less than 2.2 kW) and at high and
low line voltages.
Topology Pulse-width-modulated High Frequency, active servo-
controlled. Dual Use of Inverter for HV generation and
for Rotor Supply
Timer An interval timer is used for the manual timing as well
as for the back-up-timer. There is an additional
hardware safety timer used to limit the maximum
exposure time to 6.5 seconds.
Manual mAs Range Small Focus: 3 through 150 mAs in 41 increments. 3, 4,
5, 6, 7, 8, 9, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30,
32.5, 35, 37.5, 40, 42.5, 45, 47.5, 50, 55, 60, 65, 70,
75, 80, 85, 90, 95, 100, 110, 120, 130, 140, and 150
mAs.
Large Focus: 3 through 500 mAs in 59 increments. 3, 4,
5, 6, 7, 8, 9, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30,
32.5, 35, 37.5, 40, 42.5, 45, 47.5, 50, 55, 60, 65, 70,
75, 80, 85, 90, 95, 100, 110, 120, 130, 140, 150, 160,
170, 180, 190, 200, 220, 240, 260, 280, 300, 325, 350,
375, and 400, 425, 450, 475, and 500 mAs.
Reproducibility 0.05 coefficient of variation for 10 consecutive
exposures, per 21CFR, 1020.31. Internal limit = 0.04.
Linearity Radiation output versus selected mAs is less than 0.10
for adjacent mAs selections as follows: (X1-X2) equal to
less than 0.10 (X1 + X2) where X1 and X2 are average
mR/mAs values for consecutive exposures, per 21CFR,
1020.31. Internal limit = 0.09.
kV Accuracy The actual value does not differ by more than +1 kV
from the indicated value.
mAs Accuracy ±5% or ±2mAs, whichever is greater, from indicated,
measured in the ground side of the tube circuit.
Post mAs Accuracy ±5% or ±2mAs, whichever is greater, from actual mAs
mA Accuracy The actual value does not differ by more than +5% for
the indicated value.
58 P/N 9-500-0246
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X-ray System
Table A-2: kV Versus mA Table
kV Large Focus Large Focus Small Focus

Reduced mA
20 75 20 20
21 80 22 22
22 85 24 24
23 90 26 26
24 95 28 28
25 100 30 30
26 100 30 30
27 100 30 30
28 100 30 30
29 100 30 30
30 100 30 30
31 100 30 30
32 100 30 30
33 85 28 28
34 80 28 28
35 80 26 26
36 75 26 26
37 75 26 26
38 70 24 24
39 70 24 24
P/N 9-500-0246 59
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X-ray System
3.3 Modes of Operation

Manual Exposure Mode kV, Filter, and mAs are user selectable.
Auto-Time Exposure Mode kV, Filter, and density are the only user-selectable factors.
The exposure terminates at a value of mAs determined by
the AEC algorithm to yield an optical density to which
the system has been calibrated. Post mAs values display
after exposure termination. This mode is valid with either
the Molybdenum or Rhodium filter selected. The
exposure mAs may be modified up to ± 80% by
incrementing or decrementing the DENSITY function. If
determination is made during the AEC sample period
(first 50 ms) that the exposure will exceed the “Back-Up-
Time”, the exposure terminates in less than one of the
limits specified in the Exposure Termination section.
Auto-kV Exposure Mode
SRL 2000 Bucky Operation When this mode, along with the Molybdenum filter, is
selected, the kV will default to 25 kV or 26 kV as set
upon installation. The starting kV may be changed by
the operator to either value. When the Rhodium filter is
selected, the kV defaults to 28 kV. Upon exposure
initiation, the AEC signal is sampled and the kV may be
incremented upward to a maximum value of 30 kV if
the Molybdenum filter is selected, or 32 kV if the
Rhodium filter is selected. The exposure will be
terminated at a mAs value near one of the selected mAs
windows (125 mAs, 165 mAs, 200 mAs, or the
AUTOmatic 200 mrad window), selectable by the
operator. The final kV and post-mAs is displayed after
exposure termination.
HTC Bucky Operation When this mode and the Molybdenum filter are selected,
kV defaults to a value determined by the Compression
Height Threshold setting. The kV defaults to 24 kV for a
compression height value less than one-half of the
compression height threshold, or to 25 kV for
compression height values above one-half of the
compression height threshold. When the Rhodium filter
is selected, kV defaults to 28 kV. The exposure terminates
at a mAs value near the selected mAs windows (125
mAs, 165 mAs, 200 mAs, or the AUTOmatic 200 mrad
window for Large Focal Spot or 38 mAs, 50 mAs, 60 mAs
for Small Focal Spot or reduced mA operation),
selectable by the operator. The final kV and post mAs is
displayed after exposure termination.
Auto-Filter This mode provides full automatic operation of all
technique factors. The starting kV values are as listed
above in Auto-kV. Upon exposure initiation, the AEC
signal is sampled to determine if the kV needs to be
incremented upward to provide an exposure within the
200 mAs window, or the 200 mrad window. When
determined by the Auto-Filter algorithm, the exposure is
momentarily interrupted and the Rhodium filter moves
into the beam in place of the Molybdenum filter. After
the kV or kV/filter is selected by the algorithm, the Auto-
Time function completes the exposure. The final kV, post-
mAs, and Filter is displayed after exposure termination.
60 P/N 9-500-0246
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X-ray System
3.4 X-ray Source, Filtration, and Collimation

X-ray Tube Varian Integral M113 series or equivalent
Focal Spot Size Per IEC 336-Measurement of X-ray tube focal spots
Large—0.3 mm, nominal
Small—0.1 mm, nominal
Tube Voltage 20 kV to 39 kV
Tube Current (High speed operation)
Large focus—100 mA minimum between 25 kV and 32
kV
Small focus—30 mA minimum between 25 kV and 32
kV
Thermal Characteristics Anode Heat Storage Capacity—210 kJ (300 kHU)
Maximum Anode Heat Dissipation Rate—60 kHU/min
Housing Heat Storage Capacity—370 kJ (500 kHU)
Maximum Housing Heat Dissipation Rate—100 Watts
(135 HU/s) free air convection
Anode Rotation High speed operation (9600 rpm minimum)
Anode Angle Large Focus: 16° target angle
Small Focus: 10° target angle

Anode Material Molybdenum
X-ray Window Beryllium, 0.8 mm thickness max.
Maximum Temperature,
Tube Housing Surface 85° C (185° F)
Tubehead Cover Surface 41° C (105° F)
Over-Temperature Protection Sensor Internally provided in series with Stator common. NC
10 Amp @240 VAC, open @ 79.4° C (174.9° F), close @
68.3° C (154.9° F)
Safety Class IEC 60601-2-28
X-ray Tube Head Cooling A fan is provided to maintain a tube housing
temperature of no greater than 85° C (185° F) with an
ambient temperature of 25° C (77° F). A fan is provided
to keep the lamp housing at a temperature no greater
than 65° C (149° F).
Added Filtration The system provides a 30 micron (0.03 mm)
Molybdenum foil filter and a 25 micron (0.025 mm)
Rhodium foil filter. The filter movement is automatic
and has position sensors for use as X-ray interlock.
Beam Quality With the Compression Paddle in the X-ray beam, the
HVL for Mo/Mo operation is equal to or greater than kV/
100 +0.03 mm Al but less than kV/100 +0.12 mm Al.
For Mo/Rh, minimum value of > kV/100 +0.03, Max <
kV/100 +0.19 mm Al.
P/N 9-500-0246 61
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X-ray System
X-ray Collimation The system detects the attached image receptor and full
field collimation is provided by an auto-aperture
mechanism with additional fixed apertures for
magnification and reduced field operation. An aperture
detection system ensures that the correct aperture is
used with the installed image receptor. Exposures are
inhibited when improper combinations are detected.
The collimator has a beam-limiting device that allows
the entire chest wall edge of the X-ray field to extend
5 mm, +2.5 mm, beyond the edge of the Image
Receptor and provides a means to ensure the X-ray field
does not extend beyond any chest wall edge of the
Image Receptor of more than 2% of the SID.
Light Field to X-ray Field Congruency The light field that passes through the X-ray beam
limitation device is aligned with the X-ray field so that
the total of any misalignment of the edges of the light
field and the X-ray field along either the length or the
width of the visually defined field at the plain of the
breast support surface does not exceed 2% of the SID.
Light Field Lamp The lamp illuminates for 30 seconds ±5 seconds upon
pressing a Light Field Lamp Button on the C-arm, or by
pressing a Compression Down Button. The lamp
extinguishes automatically when X-ray exposure is
initiated. A shatter shield is provided.
Light Field Illuminance The light localizer has a minimum illuminance of 160
lux and meets all of the requirements of 21CFR, section
1020.31. The lamp voltage is the least amount required
to assure 160 lux at low line. A shatter shield surrounds
the lamp. Lamp is service adjustable to provide
alignment of the light field to the X-ray field.
Light Field Mirror The light field mirror is motor driven out of the X-ray
field within 1.0 sec of X-ray initiation signal. Position
sensors provide for X-ray interlock. The lamp position is
adjustable between large focal spot and small focal spot
to provide proper light field to X-ray field congruency
required for a bi-angle target X-ray tube.
62 P/N 9-500-0246
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Accessories
4.0 Accessories
4.1 Compression Paddles
Compression Paddles The compression paddles are transparent and the full
field paddles are marked with the location of the AEC
sensor positions. These markings are not detectable on
film when imaged with 1 cm of acrylic attenuator at 22
kV to an Optical Density of 1.2 OD. The paddle
attenuation is less than 20% (reduction of mR/mAs) at
28 kV. The full field paddles are adjustable to provide
focal spot, compression device and image receptor
alignment requirements.
The compression paddles including the frame and
compression device maintain a parallel compression
and do not deflect by more than 1 cm difference from
any surface providing compression under maximum
motorized compression force (except for FAST paddles).
Compression Paddle Sizes Available paddles:
18 x 24 cm Full Field Contact
24 x 30 cm Full Field Contact
7.5 cm Spot Contact/Magnification
10 cm Contact/Magnification
10 cm Open (Rectangular) Localization
10 cm Perforated Localization
15 cm Contact/Magnification
15 cm Open (Rectangular) Localization
15 cm Perforated Localization
18 x 24 Full Field FAST Paddles
24 x 30 cm Full Field FAST Paddles
Ultrasound Paddle
Small Breast Paddle
The chest wall edge of the compression paddle does not
extend beyond the chest wall edge of the image
receptor by more than 1% of the SID when tested with
the compression paddle placed above the breast
support surface at a distance equivalent to standard
breast thickness. The shadow of the vertical edge of the
compression paddle is not visible on the image.
P/N 9-500-0246 63
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Accessories
4.2 Apertures
There are five apertures for all combinations of paddles and receptors.
Auto-Aperture
7.5 cm Spot Contact
7.5 cm Spot Magnification
10 cm Coned
Magnification Full Field
4.3 Magnification
Magnification Factor 1.8X (2.25 cm above the surface) for platform and table
devices
Material of breast support surface
Platform: Polycarbonate
Table: Carbon Fiber
Size of breast support surface 12 x 16.5 cm minimum to provide full 18 x 24 cm full
field magnification at 1.8X.
4.4 Image Receptors

Image Receptors The Image Receptor Support Device is designed to
accept the following receptors, which are inserted from
the front of the c-arm.
18 x 24 cm front load cassette holder (used with
magnification platform)
18 x 24 cm SRL 2000 Bucky
24 x 30 cm SRL 2000 Bucky
18 x 24 cm HTC Bucky
24 x 30 cm HTC Bucky
Magnification Table
Aluminum Equivalence The carbon fiber breast support surfaces of the Buckys
and the Magnification Table have an Aluminum
Equivalence of less than 0.3 mm.
64 P/N 9-500-0246
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Appendix B—Alert Codes and Messages
Alert Codes and Messages
1.0 Alert Codes and Messages

This section lists the alert codes that appear in the Run Mode screen when a malfunction
occurs, and other pertinent information.
Table B-1: Affinity Series Alert Codes and Messages
No. Alert Name Alert Messages Comment

N/A ERROR_KEYBOARD STUCK KEYBOARD Alert message produced if any of the Control Panel buttons
STUCK are closed during powerup. Initialization is stopped until the
button is opened.
N/A XRAY FOOTSWITCH STUCK XRAY Alert message produced if the X-ray footswitch is closed
FOOTSWITCH during initial power up. Initialization is stopped until the
STUCK switch is opened. Note: Footswitch must be enable for this
test by setting S2 switch 3 to OFF (on Host Microprocessor
Board).
1 BACKUP_TIMER CONTROL Exposure time required exceeded Backup timer maximum.
2 CALCULATED_EXPOSURE_EXCE EXP > BACKUP AEC algorithm predicts exposure will exceed the
EDS_MAX programmed maximum exposure mAs.
3 XRAY_SWITCH_NOT_RELEASED X-RAY SWITCH Must release X-ray Button following exposure.
5 AEC_SIGNAL_SATURATED EXP TIME AEC circuit returned invalid signal (saturated).
6 CARM_SAFETY_SWITCH_ERROR C-ARM SAFETY Actuator error—C-arm vertical drive safety circuit has been
activated. C-arm movement is impeded.
8 INTERLOCK_FAULT INTERLOCK X-ray high voltage interlock (AJ13-4) was found high during
start of X-ray.
9 AEC_NO_SIGNAL_ERROR EXP < MIN TIME AEC circuit returned invalid signal (no signal).
10 XRAY_SWITCH_FAULT XRAY SWITCH X-ray Button early release.
12 NV_RAM_ERROR NV RAM ERROR Non-volatile RAM check failed at startup. Calibration
values may have been corrupted.
15 UNDEFINED_SYSTEM_ERROR SYSTEM ERROR System has generated an undefined error code, the result
of a programming error.
17 STORED_PARAMETER_ERROR PARAMETER The stored calibration value is out of range, indicating
possible corruption of the calibration RAM.
20 TUBE_ROTOR_FAULT CONTROL ROTOR OK low.
21 HTC_MIN_ERROR EXP TIME Calculated exposure time is less than HTC minimum travel
time.
25 HV_FAULT_DETECTED CONTROL HV fault.
27 FILAMENT_SUPPLY_ERROR CONTROL Filament check in boost routine not within 12.5% of
adaptive table of DAC values.
44 MA_SENSE_ERROR CONTROL mA sense >80 mV during pre-exposure or mA sense is not
within 12.5% of expected value during exposure.
45 KV_SENSE_ERROR CONTROL kV sense (J207-3) not with 12.5% expected value during
exposure.
51 BUCKY_ERROR BUCKY Error in Bucky comm exposure attempt.
53 NO_CASSETTE_ERROR NO CASSETTE Cassette required for exposure.
54 CASSETTE_NOT_REMOVED REMOVE CASS Cassette not removed after exposure.
P/N 9-500-0246 65
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Alert Codes and Messages
Table B-1: Affinity Series Alert Codes and Messages (Continued)
No. Alert Name Alert Messages Comment

61 CARM_DRIVE_ERROR CARM DRIVE C-arm drive circuit reported an error.
62 CARM_SWITCH_ERROR C-ARM SWITCH C-Arm Buttons active during power up.
64 CARM_SWITCH_NOT_RELEASED C-ARM SWITCH Can’t start X-ray with C-arm switch depressed.
68 COMM_ERROR Console Communication fails between Host and Control Panel.
Communication
71 MIRROR_FAULT MIRROR Mirror detected as not moving away from X-ray field during
an X-ray exposure attempt.
72 FILTER_ERROR FILTER Incorrect filter position.
73 TUBEHEAD_COMM_ERROR SYSTEM ERROR Host board is unable to communicate with Tubehead
Controller during bootup.
74 COLLIMATOR_LAMP_ERROR LAMP Lamp in wrong position for exposure.
75 AUTO_APERATURE_ERROR APERATURE Unable to change auto aperture (3 sec. time out).
76 FIXED_APERTURE_ERROR NO APERTURE No aperture.
77 INCORRECT_APERTURE WRONG Incorrect aperture.
APERTURE
78 TUBEFAN_STATUS_ERROR TUBE FAN Tube Fan status hardware reports an error.
79 TUBEHEAD_STATUS_ERROR TUBE HEAD Tubehead Controller returns a bad or incorrect status.
80 COMPFORCE_COMM_ERROR SYSTEM ERROR Host board is unable to communicate with Compression
Paddle Controller.
84 TUBEHEAD_COMM_ERROR SYSTEM ERROR Host board is unable to communicate with Tubehead
Controller.
85 BOOST_TUBEHEAD_COMM_ERR SYSTEM ERROR During boost, Host board is unable to communicate with
OR Tubehead Controller.
86 AF_EXPOSURE_TUBEHEAD_CO SYSTEM ERROR During Auto-Filter Exposure, Host board is unable to
MM_ERROR communicate with Tubehead Controller.
90 FLASHER_COMM_ERROR AUTO ID Flasher does not respond.
92 PRINTER_NO_PAPER_ERROR PRINT NO PAPER
66 P/N 9-500-0246
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Appendix C—Forms and References
Introduction
1.0 Introduction
This section provides the user with reproducible pages that they can copy and have available
for daily use.
2.0 System Startup and Clinical Procedure Checklist

See “Chapter 2—System Controls and Indicators” and “Chapter 5—Clinical Procedures” for
detailed information about any of these tasks.
❑ 1. Tests for System Integrity
❑ 2. Verify—Film Labeling option is connected
❑ 3. Turn on the system with the Circuit Breaker
❑ 4. Check for the Run Mode Screen
❑ 5. Functional Check—C-arm Controls
❑ 6. Functional Check—Tubehead Controls
❑ 7. Functional Check—Emergency Off Switch
❑ 8. Reset the Emergency Off Switch and turn the Circuit Breaker Off then On
❑ 9. Install the appropriate accessories for procedure.
❑ Verify—Bucky, or Cassette Holder and Magnification Tray are installed
❑ Verify—Compression Paddle is installed
❑ Verify—Face Shield is installed
❑ Verify—Aperature is installed
❑ 10. Set the Exposure Techniques
❑ 11. Position the Patient
❑ 12. Apply Compression
❑ 13. Make the Exposure
❑ 14. Evaluate post-exposure information.
❑ 15. Label the film (option).
P/N 9-500-0246 67
Operator’s Manual
System Default Record Sheets
3.0 System Default Record Sheets
Name _______________________________ Date ___________________________
System Serial Number __________________ System Location __________________
1. Copy these three default Record sheet pages.

2. Record the selected defaults for this system on these worksheets and store them with the
manual.
Table C-1: User Default Settings
User Defaults
Field Available Choices Comments
Compression Release Manual
Automatic
Full Compression 10% 20% 30% 40% 50% 25-40 lb of compression
60% 70% 80% 90% 100%
Pre Compression 10% 20% 30% 40% 50% 15-30 lb of compression
60% 70% 80% 90% 100%
Compression Mode Full
Pre
Film ID None Printer Auto-ID Rapid ID
Force Units Newtons lb
Cassette Sense On Off
Date mm/dd/yyyy mm/dd/yyyy US format
dd.mm.yyyy International format
dd.mm.yyyy
Time hh:mm AM 12 h Example: 01:30 PM (12 hour clock) is the same
as 1330 (24 hour clock)
hhmm 24 h
68 P/N 9-500-0246
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Table C-2: Selected Exposure Technique Defaults
Exposure Defaults
Technique Manual Auto-Time Auto-kV Auto-Filter
kV
kV (Mo) kV (Mo) Starting kV (Mo) Starting kV (Mo)
mAs
Large Focal Spot
Not Selectable Not Selectable Not Selectable
Small Focal Spot
Density Not Selectable

-5 to Normal (0) to +5 -5 to Normal (0) to +5 -5 to Normal (0) to +5
Screen-Film Film 1 Film 1 Film 1 Film 1
Film 2 Film 2 Film 2 Film 2
Film 3 Film 3 Film 3 Film 3
Focal Spot Large Large Large Large
Auto-kV Not Selectable Not Selectable Large: Large:
Window 125 mAs 165 mAs 200 mAs Auto
200 mAs Auto
Small:
38 mAs 50 mAs
60 mAs Auto
Default Selects the mode in which the system defaults to when it is turned on. This can be selected or changed in
Exposure any mode.
Mode ______________________________________
Default Mag Selects the default mode for the system when a Magnification device is installed. This can be selected or
Mode changed in any mode.
______________________________________
P/N 9-500-0246 69
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Table C-3: Selected Magnification Device Exposure Technique Defaults
Exposure Defaults Mag Mode

Technique Manual Auto-Time Auto-kV
kV
kV (Mo) kV (Mo) Starting kV (Mo)
mAs
Small Focal Spot
Not Selectable Not Selectable
Density Not Selectable

-5 to Normal (0) to +5 -5 to Normal (0) to +5
Screen-Film Film 1 Film 1 Film 1

Film 2 Film 2 Film 2
Film 3 Film 3 Film 3
Focal Spot Small Small Small
Auto-kV Window Not Selectable Not Selectable Small:
38 mAs 50 mAs
60 mAs Auto
Default Exposure Mode Selects the mode the system defaults to when it is turned on. This can be selected or changed in
any mode.________________________________________
Default Mag Mode Selects the default mode for the system when a Magnification device is installed. This can be
selected or changed in any mode. __________________________________________
70 P/N 9-500-0246
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Available Accessories for the Affinity
4.0 Available Accessories for the Affinity

Table C-4: List of Available Accessories
Part Number Description
Manuals
9-800-0040 Affinity Manual Package
Paddles
3-000-4571 24 x 30 cm Standard Paddle
3-000-4572 18 x 24 cm Standard Paddle
3-000-4579 10 cm Contact/Magnification Paddle
3-000-4580 10 cm Perforated Localization Paddle
3-000-4581 15 cm Perforated Localization Paddle
3-000-4582 15 cm Contact/Magnification Paddle
3-000-4583 7.5 cm Spot Contact/Magnification Paddle
3-000-4584 10 cm Open Localization Paddle
3-000-4585 15 cm Open Localization Paddle
3-000-4603 24 x 30 cm FAST Paddle
3-000-4604 18 x 24 cm FAST Paddle
3-000-5080 Ultrasound Paddle
Image Receptors
3-000-3121 18 x 24 cm Front Load Cassette Holder
4-000-0241 18 x 24 cm HTC Bucky
4-000-0242 18 x 24 cm SRL 2000 Grid System
4-000-0243 24 x 30 cm HTC Bucky
4-000-0244 24 x 30 cm SRL 2000 Grid System
Apertures
3-000-5086 7.5 cm Spot Aperture
3-000-5087 7.5 cm Spot Magnification Aperture
3-000-5088 10 cm Coned Aperture
3-000-5084 Auto-Aperture
3-000-5085 Magnification Full Field
Other
2-425-3020 View Markers
ASY-00530 Crosshair Mount Assembly
3-000-5091 Magnification Table
3-000-4594 Magnification Platform
3-000-5020 Footswitch
3-405-7071 Face Shield
9-400-0241 Localization Package
9-400-0242 Operator Shield Kit
9-400-0278 Remote Control Kit
8-005-0007 Affinity AutoFilm I.D.
8-005-0008 Affinity Rapid I.D.
MME-00271 Speciality Kit of 14 View Markers
ASY-00717 Integrated Bucky Markers 18 x 24 cm Bucky
ASY-00718 Integrated Bucky Markers 24 x 30 cm Bucky
P/N 9-500-0246 71
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Aperture Compatibility
5.0 Aperture Compatibility

Table C-5: Aperture Compatibility
Hologic
Other
Hologic 24 x 30
Hologic Hologic (receptors not
Hologic 18 x 24 Linear Linear
Magnification 18 x 24 manufactured by
IR Device and and
Device Cassette Hologic)
HTC Bucky HTC
Bucky
Focal Spot S L S L S L S L S L
No Paddle Auto Auto Magnification Auto Auto
Full Field
18 x 24 cm Paddle Auto Auto Magnification Magnification Auto
Full Field Full Field
24 x 30 cm Paddle Auto Auto
10 cm Contact/ 10 cm Magnification Magnification Magnification Magnification
Magnification Coned/ Full Field Full Field Full Field Full Field
Paddle Auto
10 cm Localization 10 cm Magnification Magnification Magnification Magnification
Paddle Coned/Auto Full Field Full Field Full Field Full Field
15 cm Contact/ Auto Magnification Magnification Magnification Auto

Magnification Full Field Full Field Full Field
Paddle
15 cm Localization Auto Magnification Magnification Magnification Auto
Paddle Full Field Full Field Full Field
7.5 cm Spot/ Auto/7.5 Spot 7.5 cm Spot 7.5 cm Spot 7.5 cm Spot Auto/7.5 Spot
Magnification Contact Magnification/ Magnification/ Magnification/ Contact
Paddle Magnification Magnification Magnification
Full Field Full Field Full Field
Ultrasound Paddle Auto Auto Magnification Magnification Auto
Full Field Full Field
72 P/N 9-500-0246
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Index
Index
A C
AEC 48 Care and Cleaning 51
AEC sensor markings 39 C-arm 1
AEC Sensor Position 18 Down button 17
AEC Sensor Position Indicator 15 Keypads 16
Affinity Unit Description 1 Rotation Angle Display 14
Alert Codes and Messages 65 Rotation Release key 17
Aligning Up Key 17
Crosshair to Localization Paddle 44 C-arm Movement Interlocks 7
Angle of the C-arm 14 cassette
Annual Maintenance 52 eject lever 33, 37
Aperture Compatibility 43, 72 holder 34
Aperture Interlock 7 removing 33
Apertures 42, 71 Cassette Sense Interlock 7
available types 42 Change Keys 13
Installing and Removing 43 Checklist
Arrow Buttons 13 Power Up and Clinical Procedure 67
AutoFilm I.D. 32, 50 Circuit Breaker 19
Auto-Filter mode 26 Cleaning 51
exposures 47 Compliance 8
Auto-kV mode 26 Label Locations 9
exposures 47 Requirements 8
Automatic Compression Release Interlock 7 Statements 8
Auto-Time mode 27 Compression Device
exposures 47 Controls and Indicators 15
Available Accessories 71 Compression Down Key 17
Compression Force Indicator 15
B Compression Handwheels 15
Bucky Compression Paddle 38
release lever 32 AEC sensor markings 39
removing 33 Applications 39
Bucky devices 32 Installing and Removing 40
Button Compression Release
C-arm down Key 17 button 12
C-arm Rotation Release 17 function keypad button 17
C-arm Up Key 17 gantry button 17
Change 13, 21 Compression sequence 48
Compression Down 17 Compression Thickness Indicator 15
Compression Release 12, 17 Compression Up Key 17
Compression Up 17 connecting Dual-Function Footswitch 45
Footswitch Controls 18 Control Panel 1
Light Field Lamp 17 Display Screens 21
Reset 13, 21 Function Keypad 12
Scroll 13, 21 Crosshair Devices 44
X-Ray Exposure 13
9-500-0246 73
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Index
D Footswitch
Controls 14, 18
Daily Maintenance 52 detaching 45
Default Exposure Modes installing 45
Setting 29 Footswitch Controls 14
detaching the Footswitch 45 Function Keypad 12
diagram of Affinity 2
DIN-style cassettes 32 G
Disinfection 51
Gantry 1
Display
Gantry Controls and Indicators 13
C-Arm Angle 14
General cleaning 51
screen 12, 21
Dual-Function Footswitch(es) 45 I
E installing
accessories 47
Early Release Interlock 7
apertures 43
ejecting cassette 33
Bucky device 32
Electrical Safety 5
cassette holder 34
Emergency Off switch 6, 14, 18
compression paddles 40
Location 6
Face Shield 31
Exposure
footswitch 45
Auto-Filter mode 47
Magnification Platform 35
Auto-kV mode 47
Magnification Table 36
Auto-Time mode 47
Integrated Bucky Markers 33
Manual mode 47
Intended Use xi
Exposure Defaults 69
Interface
Mag Mode 70
Three main screens 21
screen 21, 25
Interlocks 7
Two sections 25
Automatic Compression Release 7
Screen, Overview 25
C-arm Movement 7
Exposure footswitch 14
Cassette Sense 7
Exposure Indicator 12
Early Release 7
Exposure Mode 26
Mirror and Filter 7
Auto-Filter 26
Internal start up tests 19
Auto-kV 26
Auto-Time 27 K
Mag Auto-kV 28
Mag Auto-Time 28 Keypads 16
Mag Manual 29
Manual 27 L
Exposure Sequence 48 Label Locations, Compliance 9
Exposure System Displays 23 Labeling the Film 50
Exposure Techniques 47 Light Field Lamp 17
F loading
Bucky device 32–33
Face Shield cassette holder 34
installing 31 locking clips 35
FAST Paddle Use 39
Film labeling options 50 M
Filter Indicator 17 Mag Auto-kV Mode 28
Filter Type LED Indicators 16
74 9-500-0246
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Index
Mag Auto-Time Mode 28 S

Mag Manual Mode 29
Magnification Platform 34 Safety 3
installing 35 Electrical 5
removing 35 Operator Radiation Shield 3
Magnification Table 36 Radiation Safety 3
indicator lights 36 Technologist and Patient 4
installing 36 Scroll keys 13, 21
loading 37 Semi-Annual Maintenance 52
removing a cassette 37 Setting Defaults 26
Maintenance 51 Exposure Modes 29
Annual 52 Settings
Daily 52 Exposure Techniques 47
Monthly 52 Shutdown Sequence 19
Manual Mode 27 STANDBY 23
exposures 47 Startup 47
Message Area 23 Startup Tests 19
Mirror and Filter Interlocks 7 Status Area 23
System
O Controls and Indicators 11
Specifications 53
On/Off switch 6
Startup 19, 47
P System Startup and Clinical Procedure Checklist 67
Paddles 71 T
Positioning the Patient 47
Techniques
Post Startup Tests 19
Exposure 47
Pre-Startup Tests 19
Technologist and Patient 4
R Turning On the System 19
Radiation Safety 3 U
READY 23
Unit Description 1
removing
Unit Measurements 54
aperture 43
Up and Down buttons 13
Bucky 34
User Defaults
cassette 37
screen 21, 24
cassette and cassette holder 35
Settings 68
Compression paddles 40
User Interface 21
Face Shield 31
Using the Operator’s Manual xiv
Magnification Platform 35
Reset button 13, 21 X
Rotation Angle Display 11
Run Mode screen 21–22 X-RAY 23
Alert Codes 65 X-Ray Exposure Button 13
9-500-0246 75
Operator’s Manual
Index
76 9-500-0246

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Artwork and Signature File For: 9-500-0246 "MANUAL, AFFINITY OPERATOR"

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Artwork and Signature File for:

9-500-0246 “MANUAL, AFFINITY OPERATOR”

Artwork consists of:

• Ninety-two (92) 8 ½ inch x 11 inch pages.

REV AUTHORED BY DATE

for Affinity Series Mammography Systems

Part Number 9-500-0246

Corporate Headquarters Europe Asia Pacific

© Copyright Hologic 2006. All rights reserved. Printed in USA.

This manual was originally written in English.

List of Figures ...................................................................................................... vii

List of Tables ........................................................................................................ ix

Chapter 1—Introduction .......................................................................................1

P/N 9-500-0246 iii

Chapter 2—System Controls and Indicators ....................................................... 11

Chapter 3—The User Interface ........................................................................... 21

Chapter 4—Accessories .......................................................................................31

Chapter 5—Clinical Procedures ..........................................................................47

Chapter 6—Care and Maintenance ..................................................................... 51

Appendix A—Specifications ................................................................................ 53

Appendix B—Alert Codes and Messages ............................................................. 65

Appendix C—Forms and References ................................................................... 67

Figure 1-1: Affinity System Description.................................................................................................. 1

P/N 9-500-0246 vii

viii P/N 9-500-0246

Table 2-1: The Function keypad Buttons and Indicators ................................................................. 12

2.0 Intended Use

3.0 Product Complaints

4.0 User Training

5.0 Quality Control

6.0 Terms and Definitions

xii P/N 9-500-0246

7.0 Warnings, Cautions and Notes

Note… Notes indicate important instructions to follow to ensure the proper

8.0 International Symbols

Potential Equalization Connection for a conductor other than the Protective

Off Power disconnection from the mains

On Power connection to the mains

WEEE Symbol indicating separate collection for electrical and

Dangerous Voltage Identifies area of potentially lethal voltage

P/N 9-500-0246 xiii

9.0 Using the Operator’s Manual

xiv P/N 9-500-0246

1.0 System Description

Figure 1-1: Affinity System Description

1.1 The C-arm

1.2 The Gantry

1.3 The Control Panel

1.4 Mammography System

Figure 1-2: Affinity Mammography System

Legend for Figure 1-2

2.1 Radiation Safety

Warning: To ensure radiological protection, restrict access to the system in

2.1.1 The Operator Radiation Shield

Figure 1-3: Operator Radiation Shield

2.2 Technologist and Patient

WARNING! It is the responsibility of the user to correct anomalies or

Warning: This system includes motorized equipment. Use care when

Warning: When examining a patient in a wheelchair, place footswitches out

2.3 Electrical Safety

WARNING! Electrical equipment used in the presence of flammable

2.4 Isolation Integrity

WARNING! To ensure proper isolation, maintain a 1.5 meter distance