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LORAD AFFINITY Series, Service Manual

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LORAD AFFINITY Series Service Manual Download Page 193

P/N 9-500-0255 

A-3

Service Manual

Appendix A: Specifications

System Specifications

1.5

C-arm Specifications

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 perpendic-
ular 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 compres-
sion 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

1.6

Compression Specifications

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 Compres-
sion 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 lb minimum 
to 40 lb maximum)

     Pre Compression

User adjustable with a nominal range of 66 N 
minimum to 132 N maximum (15lbs mini-
mum 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.

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.

Summary of Contents for AFFINITY Series

Page 1: ...1 REV AUTHORED BY DATE A TAMBASCIO 7 24 2003 REV DRAFTED BY DATE BILL MOSES 8 5 2003 PROPRIETARY This document contains proprietary data of Hologic Inc No disclosure reproduction or use of any part thereof may be made except by written permission from Hologic REV RELEASE DATE 8 14 03 3 Artwork and Signature File for 9 500 0255 MANUAL AFFINITY SERVICE Artwork consists of Two hundred and twelve 212 ...

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Page 5: ...Service Manual for Affinity Series Mammography Systems Part Number 9 500 0255 Revision 005 ...

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Page 7: ... 1 1 1 0 Introduction 1 1 1 1 Intended Uses 1 1 1 2 Required Tools and Equipment 1 2 2 0 Safety 1 2 2 1 Electrical Safety 1 2 2 2 Interlocks 1 3 2 3 Mechanical Safety 1 3 2 4 Radiation Safety 1 4 3 0 Unit Description 1 5 3 1 Gantry and C Arm 1 5 3 2 Control Panel 1 7 4 0 Compliance Data 1 8 4 1 Compliance Statement 1 8 4 1 1 Remote Indication of the Ready State 1 8 4 2 Certifiable Components 1 9 4...

Page 8: ... the Unit Accessories 2 8 3 6 1 Exposure Footswitch 2 8 3 6 2 Dual Function Footswitch es 2 9 3 6 3 Connecting Film Labeling Devices 2 10 3 7 Initial Start Up Procedures 2 10 3 7 1 Remote X ray ON Light Configuration 2 10 3 7 2 Initial Power Up 2 11 3 7 3 Setting Operational Parameters 2 11 3 8 Final Operational Setup 2 11 3 8 1 Installing the Radiation Shield 2 12 Chapter 3 Functional Checks Sett...

Page 9: ...21 5 8 Performance Test Large Focal Spot Mo 4 21 5 9 Performance Test Large Focal Spot Rh 4 22 5 10 Initial Calibration Small Focal Spot Mo 4 23 5 11 kV Tracking Small Focal Spot Mo 4 24 5 12 Initial Calibration Small Focal Spot Rh 4 24 5 13 Starting AEC Values Small Focal Spot 4 25 5 14 Performance Test Small Spot Mo 4 25 5 15 Performance Test Small Spot Rh 4 26 5 16 HTC Factor Offset Calibration...

Page 10: ...2 Light Field Illuminance Check 4 55 8 0 Mechanical Adjustments 4 56 8 1 Compression Chain Tension Adjustment 4 56 8 2 Compression Display Potentiometer Adjustment 4 57 8 3 Compression Force Load Cell Setting 4 57 8 4 C arm Safety Microprocessor Board Calibration Vertical Drive Force Load Cell Setting 4 58 9 0 Maintenance Procedures 4 59 9 1 kV Control Offset Calibration 4 59 Chapter 5 Maintenance...

Page 11: ... 5 4 Low Voltage Power Supply 6 19 2 5 5 C arm Safety Microprocessor Board 6 19 2 6 Internal Gantry Components 6 20 2 6 1 Main Circuit Breaker 6 20 2 6 2 The C arm Angle Detent Microswitch 6 21 2 6 3 The C arm Rotation Potentiometer 6 22 2 6 4 The C arm Vertical Drive Actuator 6 23 3 0 C Arm Components Remove and Replace 6 26 3 1 C Arm Frame Components 6 29 3 1 1 Patient Face Shield Installation a...

Page 12: ... Parts Lists 7 1 Appendix A Specifications A 1 1 0 System Specifications A 1 1 1 Electrical Input Specifications A 1 1 2 Unit Measurements A 1 1 3 Operating Environment A 2 1 4 Storage Environment A 2 1 5 C arm Specifications A 3 1 6 Compression Specifications A 3 1 7 Compression Paddles A 4 1 8 Apertures A 5 1 9 Magnification A 5 1 10 Image Receptor Support Device A 6 1 11 C arm Functions A 6 1 1...

Page 13: ... Calibration Screen 1 Calibration Mode 3 11 Figure 3 12 Calibration Screen 2 Calibration Mode 3 11 Figure 3 13 Calibration Screen 3 Calibration Mode 3 12 Figure 3 14 Calibration Screen 4 Calibration Mode 3 12 Figure 4 1 Compression Force Calibration Setup 4 7 Figure 4 2 Compression Thickness Calibration Setup 4 8 Figure 4 3 High Voltage Generator Calibration Setup 4 10 Figure 4 4 Example Filament ...

Page 14: ...s 6 31 Figure 6 21 Filament Protection Board Removal 6 32 Figure 6 22 C arm Switch Pads Removal 6 33 Figure 6 23 C Arm Accessory Detect Board Removal 6 34 Figure 6 24 Tubehead Covers Removal 6 35 Figure 6 25 X ray Tube Removal 6 36 Figure 6 26 Tubehead Control Board Removal 6 38 Figure 6 27 C Arm Cooling Fan Removal 6 40 Figure 6 28 Aperture Detect Board Removal 6 41 Figure 6 29 Filter Shifter Ass...

Page 15: ... 2 Gantry Left and Right Side Components Parts List 7 2 Table 7 3 C Arm Frame Components Parts List 7 2 Table 7 4 C Arm Tubehead Components Parts List 7 2 Table 7 5 C Arm Compression Device Components Parts List 7 3 Table 7 6 C Arm Image Receptor Support Device Parts List 7 3 Table 7 7 Miscellaneous Parts List 7 4 Table A 1 Kv versus mA table A 9 Table B 1 Filament Protect Board PN 1 003 0289 Test...

Page 16: ... Sensor Combinations B 8 Table B 20 Affinity Series Fuses B 10 Table B 21 Microprocessor Board PN 1 003 0493 Jumper Settings B 11 Table B 22 Communications Interface Board PN 1 003 0434 Jumper Settings B 11 Table B 23 C Arm Safety Board PN 1 003 0440 Jumper Settings B 11 Table B 24 HV Control Filament Board PN 1 003 0485 Jumper Settings B 12 ...

Page 17: ... information for unpacking positioning and installing the unit Attaching the interconnections mounting the accessories and connecting the unit to power are also covered Chapter 3 Functional Checks Setting Defaults This chapter sequences the operator through performance and functional checks and setting system defaults and user preferences Chapter 4 Calibrations and Performance Checks This chapter ...

Page 18: ...data or corruption of files in software applications Note Notes indicate important information that must be followed to ensure the proper operation of the system 2 0 Acronym List Table P 1 provides a list of the common Acronyms used throughout the Affinity Series Service Manual Table P 1 List of Acronyms for Affinity Acronym Definition 21 CFR FDA Code of Federal Regulations Title 21 A Amps ACR MAP...

Page 19: ...meters Mo Molybdenum MQSA Mammography Quality Standards Act mrad milli Radiation Absorbed Dose N Newtons OD Optical Density PCB printed circuit board PMMA Polymethyl Methacrylate PN Part Number PWM pulse width modulated Rh or Rho Rhodium SID Source to Image Distance V Volts VAC Volts Alternating Current VDC Volts Direct Current VTA Vertical Travel Assembly Table P 1 List of Acronyms for Affinity A...

Page 20: ...xiv P N9 500 0255 Service Manual Preface Acronym List ...

Page 21: ...oduction The LORAD Affinity is a dedicated mammography system which features automatic and manual exposure modes a compact control panel and optional film labeling abilities Figure 1 1 1 1 Intended Uses The unit is intended to function in screening and diagnostic mammography procedures Figure 1 1 The Affinity System ...

Page 22: ...ected equipment as per IEC 601 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 Table 1 1 Required Tools and Equipment for Installation and Maintenance Standard Hand Tools non metric Oscilloscope 100 MHz min 2 channel Digital Multimeter DMM Hex Wrench Set standard Radiation Meter...

Page 23: ...s except C arm UP until the obstruction is cleared C arm movement is also prohibited when compression force exceeds 50 N 12 lb Automatic Compression Release Interlock Installing a Localization Paddle disables the compression release function including automatic compression release if enabled Early Release Interlock When the x ray exposure switch is released prior to the end of the exposure this in...

Page 24: ...quirements of 21CFR Part 1020 IEC 601 2 7 and IEC 601 1 3 The shield is rated for a 0 5 mm Pb lead equivalence To ensure radiological protection restrict access to the unit in accordance with local regulations The exposure duration is limited by the following normal conditions The manual mAs timer The Automatic Exposure Control circuits The exposure duration is also limited by the following abnorm...

Page 25: ...mergency OFF switches 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 angle The Gantry also supports an externally mounted radiation shield that protects the operator from exposure during the exam and houses the input power connector panel and Footswitch receptacles The C arm is made up of the following major assemblies...

Page 26: ...Slot 5 Face Shield 6 Compression Device 7 Compression Thickness Force Displays 8 Image Receptor Support Device 9 C Arm Angle Display total of two one on each side 10 Emergency OFF Switch total of three two on front of Gantry and one on rear 11 Patient Handle 12 Radiation Shield 13 Footswitch 14 Control Panel 15 X ray Footswitch not shown mounted on Gantry base plate behind Radiation Shield Figure ...

Page 27: ...LCD Display Window It is used to set exposure techniques and parameters provide operator instructions display alert and system status messages and initiate x rays Legend for Figure 1 3 1 LCD Display Window 2 Exposure Parameters Area 3 Exposure Factor Selection Area 4 Exposure Parameter Selection Area 5 Message Area 6 Status Area 7 Function Keypad 8 Scroll Keys 9 Change Keys 10 Reset Key 11 Compres...

Page 28: ...ISO 9001 1994 EN 46001 1993 ISO 13485 IEC 601 1 Safety Requirements For Medical Electrical Systems IEC 601 1 2 Electromagnetic Compatibility IEC 601 1 3 General Requirements for Radiation Protection IEC 601 1 4 Safety of Programmable Electrical Medical Systems IEC 601 2 7 Safety Of High Voltage Generators IEC 601 2 28 Safety of X ray Source Assemblies IEC 601 2 32 Safety of Associated Equipment IE...

Page 29: ...mponents are identified using individual serial numbers in addition to the serial number of the overall LORAD unit Item Manufacturer X ray Tube Varian IM 113R Beam Limiting Device LORAD High Voltage Generator LORAD X Ray Control LORAD Image Receptor Support Device LORAD Bucky 18 x 24 cm LORAD Bucky 24 x 30 cm LORAD ...

Page 30: ...abels Compliance labels and nameplates are positioned appropriately on the Affinity Series mammography unit Nameplates contain the unit s serial number and manufacturing date When calling in for support please reference the system serial number noted on Label 1 Figure 1 4 Compliance Label Locations ...

Page 31: ... ceiling clearance for movement and handling of C arm controls Radiation Shield clearances The protective radiation shield extends 24 from the side of the unit The room layout must provide enough space to allow the user to maneuver around the radiation shield when it is attached Movement clearance Always take into consideration space allocation for patient and technologist movement Avoid obstructi...

Page 32: ...ion Shield Upon receipt perform the following before opening the containers Inspect each container for damage Note any damage on the shipping manifest Notify LORAD of any external shipping damage that may have occurred 2 2 Un Crating the Unit The Affinity Gantry is crated and shipped in a prone position see Figure 2 2 Be sure to have the necessary machinery and personnel available to move heavy me...

Page 33: ...hipping damage is of a concealed nature contact the carrier as soon as such damage is found and request an inspection for shipping damage Normally any claims for shipping damage must be completed within 15 days of receiving the shipment Warning Never pull on the C arm as the unit is top heavy To prevent injury to personnel and or damage to equipment care must be taken when un crating the unit 5 Wh...

Page 34: ...ion 3 4 Securing Unit in Position Section 3 5 Installing the Unit Accessories Section 3 6 Initial Start Up Procedures Section 3 7 Final Operational Setup Section 3 8 Note Do not replace any covers or panels until told to do so 3 1 Input Power Configuration The isolation transformer must be configured to match the power source at the site This portion of the manual details the steps to properly con...

Page 35: ...he cover aside 3 Remove the Rear Connector panel and shroud as per Chapter 6 Section 2 1 3 Pull the panel slightly away from the unit then let it hang by the attached wiring harness 4 To gain access to the input power assembly chassis remove the Lower Rear panel as per Chapter 6 Section 2 1 4 Steps 1 through 3 The isolation transformer is mounted on the lower shelf of the input power assembly chas...

Page 36: ... on the input power assembly chassis as follows 1 Locate the removable power distribution assembly and connect the remote X ray ON and Power ON cables to the terminal board as shown in Figure 2 4 2 Complete the remote cables and light installation following local guidelines 3 Replace the Gantry lower rear upper rear and rear connector panels Do not replace rear connector panel shroud at this time ...

Page 37: ...ed hardware 2 Route the Control Panel and EMO Switch harness through the strain relief Figure 2 5 Item 4 then out the access hole in the housing bracket Make all the appropriate harness connections then tighten the strain relief 3 Mount the Control Panel housing Figure 2 5 Item 2 to the housing bracket using the supplied hardware Note that an EMO switch is mounted on the housing 4 Align the tabs o...

Page 38: ...r in accordance with site specification drawings and or local building codes Note Do not replace left and right side panels at this time 3 6 Installing the Unit Accessories This section provides instructions for installing the following accessories Exposure Footswitch Dual Function Footswitch es Film Labeling Devices 3 6 1 Exposure Footswitch When the exposure footswitch is installed on a machine ...

Page 39: ...FF 3 6 2 Dual Function Footswitch es A dual function footswitch provides C arm and Compression Up or Down movement Normal system configuration consists of one footswitch with an optional second footswitch Two jacks on the lower rear of the Gantry provide connections for the Footswitch es To connect the Footswitch es perform the following 1 Connect the Footswitch es connector to the left and or rig...

Page 40: ...Figure 2 6 Item 2 on the rear of the Gantry 3 Plug the Printer power cord into the power receptacle on the rear of the Printer then plug the opposite end into the Printer Power outlet Figure 2 6 Item 4 on the rear of the Gantry 3 7 Initial Start Up Procedures At this point in the Affinity Series Mammography System installation procedures the unit should be permanently mounted in position with all ...

Page 41: ...informing the user that internal checks are being performed G Verify that the Control Panel displays the Run Mode screen after power up H If the AutoFilm I D is installed verify that the Patient Information Screen is displayed Refer to the AutoFilm I D User s Guide Note If the system detects a fault condition during startup an appropriate message will appear on the screen The power up sequence is ...

Page 42: ...e To ensure radiation shield is properly aligned on the gantry do not tighten hardware at this time 2 While aligning the pins on the radiation shield mounting bracket with their corresponding holes on the top of the gantry position the bottom of the Radiation Shield in the lower mounting bracket on the right side of the Gantry 3 Secure the radiation mounting bracket to the top of the gantry with t...

Page 43: ...dicators refer to the Affinity Series Operator s Manual PN 9 500 0246 Legend for Figure 3 1 1 Emergency OFF Switches EMO Two on front of Gantry one on rear For those sys tems with the Remote Control Panel installed a fourth EMO switch is located on the control panel mounting block 2 Circuit Breaker 3 X ray Footswitch 4 Dual Function Footswitch 5 Rotation Angle Display 6 C Arm Controls 7 Button Key...

Page 44: ... checks detailed previously before applying power to the unit Always correct discrepancies before turning the unit on and using it clinically 1 If a film labeling device is installed apply power to the device AutoFilm I D The Auto Film I D has a rocker type power switch 2 Flip the circuit breaker on the rear of the Gantry up ON position The back light of the display is indication that power is app...

Page 45: ...rmine if the electro mechanical subsystems are functioning Correct all discrepancies before releasing the unit to the user Legend for Figure 3 2 1 Light Field Lamp 2 Compression Down Switch 3 C Arm Down Switch 4 C Arm Rotation Release Switch 5 Compression Release Switch 6 Compression Up Switch 7 C Arm Up Switch 8 Filter Type LED Indicators Mo or Rh Figure 3 2 The C arm Controls ...

Page 46: ... readout changes accordingly D Ensure compression device stops when button is released and brake is engaged won t easily move manually 3 Compression Release Figure 3 2 Item 5 A Press and release the Compression Release button B Verify the compression device moves up and stops automatically C Verify the compression brakes release handwheel turns easily in both directions 4 Compression Up Figure 3 2...

Page 47: ... identical to that of the corresponding controls on the C arm keypads C Verify footswitch functionality as per the C arm Controls Procedures Steps 2 4 5 and 6 Warning Upon completion of footswitch functional check ensure the footswitch is positioned in such a way as to prevent accidental activation by patients or operators Tubehead Controls 1 C arm Up Figure 3 5 Item 2 A Verify C arm moves up whil...

Page 48: ...D Select the Rh filter via the Run Mode Screen on the Control Panel E Verify that the Rh LED Figure 3 2 Item 8 lights on each of the 7 button Switch Pads F Ensure the Run Mode s Filter data line indicates Rh Emergency OFF Switches Figure 3 4 Emergency OFF A Press any of the three EMO switches on the Gantry Verify power is immediately removed B To reset turn the EMO switch one quarter turn then pla...

Page 49: ...anual Chapter 3 Functional Checks Setting Defaults System Power Up Legend for Figure 3 5 1 Tubehead Controls loca tion 2 C Arm Up Switch 3 C Arm Down Switch 4 C Arm Rotation Release Switch Figure 3 5 The Tubehead Controls 2 3 1 4 ...

Page 50: ...ad Contains the following controls keys 3 Scroll Keys Up Down arrow keys used to move the on screen highlight cursor 4 Change Keys Left Right arrow keys used to select options on highlighted field 5 Reset Key Used to acknowledge and clear an alert message When used with Change keys it allows user to change screens When used with Scroll keys it adjusts the contrast of the Control panel LCD display ...

Page 51: ... Mode Screen Figure 3 7 is displayed after power up The data fields allow the operator to select exposure techniques receive mes sages regarding system status make x ray exposures initiate compression release and select filter The screen also offers a field to choose the com pression release method The User Default Screen Figure 3 8 allows the user to set the defaults for compression release compr...

Page 52: ...re Default Screen from the Run Mode Screen press Reset Right Arrow twice To go back to the Run Mode Screen from the Exposure Default Screen press Reset Left Arrow twice from the User Default Screen press Reset Left Arrow once Note Access to the Calibration Mode the Debug Screen and the three Calibration Screens will require the servicing engineer to configure a DIP switch on the Microprocessor Boa...

Page 53: ...ibration values such as Filament Current Calibration Screen 2 Figure 3 12 is accessed when setting up and cali brating the automatic exposure con trol system including the AEC Gain AEC Offset and AEC Density When Cal Screen 2 is selected the machine is fixed in Auto Time Mode Figure 3 11 Calibration Screen 1 Calibration Mode Figure 3 12 Calibration Screen 2 Calibration Mode ...

Page 54: ... the backup timer test When setting CF CAL and SPECIAL commands pressing Reset Comp Rel will send the selected command Calibration Screen 4 Figure 3 14 is accessed to set the x ray tube type perform AEC Gain Calibra tion set the wait time between exposures when in service mode and to set the Auto Filter Threshold Figure 3 13 Calibration Screen 3 Calibration Mode Figure 3 14 Calibration Screen 4 Ca...

Page 55: ...sette Sense Prevents x rays from being taken if the Bucky is not loaded or if the cassette is not ejected from the Bucky after it is exposed Select ON or OFF Note When the Cassette Sense is set to ON the system will remain in Standby until a new cassette is installed Date US format or International format Time 12 hour format or 24 hour format 5 0 Setting Exposure Technique Defaults The exposure te...

Page 56: ...ary to make films at the optimum optical density with ideal contrast To do this the user must set a timing win dow that determines when to terminate the exposure The timing window choices for Large FS are 125 165 or 200 mAs and the choices for Small FS are 38 50 or 60 mAs The Auto timing window based on breast thickness should be selected by those users who are required to meet the 2 mGy 200 mrad ...

Page 57: ...tion or physicist accreditation please wait a minimum of 40 seconds between exposures to allow adequate cooling of the x ray tube and high voltage electronics 2 0 Calibration Procedures Use the following procedures to setup check and calibrate the mammography unit s exposure generating system the automatic exposure control system C arm Safety microprocessor board and the compression control system...

Page 58: ... Table 4 1 shows all the switch settings and their functions 4 Turn power ON When the Run Mode appears the unit is in the Service Mode 5 The three user screens Run Mode User Default and Exposure Default the Debug screen and the three calibration screens Cal 1 Cal 2 Cal 3 and Cal 4 are now accessible by pressing Reset Left Arrow or Reset Right Arrow Table 4 1 Microprocessor S2 DIP Switches Switch F...

Page 59: ...ocal Spot Size Auto Time User selects kV Screen Film and Focal Spot Size Auto kV System automatically selects kV and mAs User selects Screen Film and Focal Spot Size Auto Filter Provides full automatic operation of all technique factors User selects Screen Film SCREEN FILM User selects film type Film 1 2 or 3 FOCUS User selects Large or Small Focal Spot Size FILAMENT On systems with HTC Buckys use...

Page 60: ...imum selectable mAs is dependent upon kV and Focal Spot AEC GAIN Used during AEC Calibration Section 5 0 AEC OFFSET Used during AEC Calibration Section 5 0 M DENSITY Used during AEC Calibration Section 5 0 SCREEN FILM User selects film type Film 1 2 or 3 FOCUS User selects Large or Small Focal Spot Size LgBcky FACTOR Used during AEC Calibration Section 5 0 HTC Factor Used during AEC Calibration Se...

Page 61: ...DS PREAMP GAIN Factory set to 1 not adjustable SPECIAL Allows user to select additional service functions NONE SELECTED No special functions selected INIT CAL DATA Used to initialize Calibration data on the Host Microprocessor board refer to Chapter 6 Section 2 3 1 Display Microprocessor Board p 6 9 CLEAR EXP CNT Resets the Exposure Counter refer to Chapter 6 Section 3 2 2 1 Exposure Counter Reset...

Page 62: ...ay Tube installed in the unit IM 113 Not selectable AEC Gain Cal Not selectable factory set to OFF Used for Factory calibration of AEC Preamp Gain Svc Rdy Time Sets the wait time between exposures when in service mode to 30 45 or 60 seconds Auto FIL TH Sets the Auto Filter kV setting that determines when to switch filters This kV setting signals the unit to switch to the Rh filter when the kV is e...

Page 63: ...t 1 0 cm from chest wall edge Install the 18 x 24 cm screening compression paddle onto the compression device 5 Highlight the CF Cal data field using the Scroll keys Press a Change key until the field reads 80 N 18 lb 6 Place a towel on the gauge or scale to protect the compression accessory from scratches or damage Use motorized compres sion to lower the compres sion device until the paddle just ...

Page 64: ...e Scroll keys Press a Change key until the field reads Thickness 3 Place 5 0 cm of acrylic on the image receptor support device Install the 18 x 24 cm compression paddle on the compression device 4 Use motorized compres sion to lower the compres sion paddle until it just touches the acrylic Use manual compression to apply 133 5 N 30 lb of force onto the acrylic 5 Press Reset Comp Release together ...

Page 65: ...eed until an additional 1 minute has elapsed 5 Using a coaxial cable Item 1 and a BNC to banana plug splitter Item 4 connect a Dig ital Multi Meter DMM Item 2 to the anode terminal Item 3 of the HV divider Item 6 Position the meter where it can be read from behind the protective radiation shield 6 Connect the HV divider s ground wire Item 8 to an unpainted metal surface on Gantry 7 Connect one end...

Page 66: ...ital Multi Meter 3 Anode 4 BNC to Banana Plug Splitter 5 Ground side of splitter Side of splitter with Tab must be connected to Common 6 High Voltage Divider 7 Cathode 8 Ground wire Attach this end of ground wire to unpainted metal surface on Gantry 9 Gantry 10 HV Adapter Cable 11 Voltage Divider Receptacle 12 HV Test Well 13 mA Current Jack not shown on left side of HV Multiplier Figure 4 3 High ...

Page 67: ... the mA Current Jack Figure 4 3 Item 13 3 Take an exposure at 30 kV manual mode 100 mAs The meter should read 100 mA If not adjust R2 on the HV Control Filament Board 4 Repeat Step 2 till the meter reads 100 mA 4 3 Filament Current mA Calibration This procedure sets the filament current to produce the desired mA at each kV station for the large and small focal spots in the Affinity This procedure ...

Page 68: ...e data fields to set the unit for a Manual mode exposure at 20 kV 40 mAs Large focus 12 Make an exposure The system will automatically adjust the starting filament values Wait 40 seconds take a second exposure Wait 40 seconds take a third exposure After each exposure check the waveform on the oscilloscope for under or overshoot Figure 4 4 Verify that the waveform appears stable and is at the cor r...

Page 69: ... the Run Mode Screen and switch to the Mo filter b Access the Calibration Screen 1 Auto Cal data field should read ON c Highlight and change the appropriate data fields to set the unit for a MAN UAL mode exposure at 20 kV 12 mAs Large focus d Highlight the Filament data field and then press Reset Compression Up together This will place you in reduced mA calibration mode e Install an HTC Bucky on t...

Page 70: ... Small Focal Spot Mo Small Focal Spot Rh kV ma Results mA Results ma Results mA Results 20 kV 75 20 21 kV 80 22 22 kV 85 24 23 kV 90 26 24 kV 95 28 25 kV 100 30 26 kV 100 30 27 kV 100 30 28 kV 100 100 30 30 29 kV 100 100 30 30 30 kV 100 100 30 30 31 kV 100 100 30 30 32 kV 100 100 30 30 33 kV 85 85 28 28 34 kV 80 80 28 28 35 kV 80 80 26 26 36 kV 75 26 37 kV 75 26 38 kV 70 24 39 kV 70 24 ...

Page 71: ... unit OFF 2 Remove the Gantry s right side panel to access the Microprocessor board as per Chap ter 6 Section 2 1 1 3 On the Microprocessor board set the unit for the service mode S2 switch 1 ON 4 Turn the unit ON 5 Access Calibration Screen 1 6 Highlight the Timer Test data field using the Scroll keys Press a Change key until the data field reads ON 7 Turn the unit OFF Table 4 4 Reduced mA Filame...

Page 72: ...ure 14 When the exposure terminates the message area along the lower part of the screen indi cates the exposure duration when the timer terminated the exposure and the status of the test 15 Verify that the test PASSED If the indication is FAILED contact LORAD Service department immediately Do not use the system clinically 16 The Timer Test field will automatically reset to OFF 17 Remove all test e...

Page 73: ... presents a guideline for typical clinical values for breast composition and thickness Note that 2 0 cm thickness imaging is not appropriate above 26 kV while 6 0 cm thickness imaging is not appropriate below 26 kV Notes When calibrating the automatic exposure control system always use the same Bucky device and the same cassette to ensure consistent results For optimum calibration results use the ...

Page 74: ...t aside taking care not to touch the film covering the sensors 5 Remove the 2 screws securing the D sub connector to the end of the AEC Detector Assembly Remove connector 6 Remove the 4 screws securing the AEC Detect board to the AEC Detector Assembly Remove the board 7 Measure the resistance across R1 and calculate the replacement value using the follow ing formula 9 50 result noted in Step 1 x v...

Page 75: ...er Using the same techniques as in Steps 8 and 9 make an exposure develop the film then measure the Optical Density 12 Make Offset adjustments to calibrate the Optical Density to the value requested by the customer Increase the Offset value if the density is too high To maintain mAs require ments 240 350 mAs it may be necessary to increase or decrease the amount of BR 12 or PMMA used 13 Make anoth...

Page 76: ...tion loaded in the cassette 6 Place 3 5 cm of BR 12 or PMMA acrylic on the Bucky centered laterally and extending approximately 1 0 cm over the chest wall edge 7 Place the AEC detector in the position closest to the chest wall Take an exposure develop the film then measure the optical density OD Note Always measure the Optical Density with the lower edge of the film flush with the front edge of th...

Page 77: ...bration Large Focus Note When calibrating with high speed contrast film each kV station will need verification and input of the Gain Offset and AEC Density 5 7 Starting AEC Values Large Focal Spot This procedure inputs recommended starting AEC values for 20 24 kV and for 31 39 kV for the Large focus 1 Input the values for Gain Offset and AEC Density used at 25 kV into the corresponding fields for ...

Page 78: ...s between 40 and 80 mAs Use absorber thicknesses to make Offset adjust ments between 200 mAs and 350 mAs Note It may be necessary to use absorber thicknesses greater than 6 0 cm to achieve the desired mAs when calibrating AEC using the Rhodium filter at higher kVs Large Focal Spot 0 030 mm Molybdenum Filter 18 x 24 cm Bucky Paddle BR 12 KODAK MIN R 2000 Film Cassette Gain Lower Thickness 40 to 80 ...

Page 79: ...r Mag Auto Time 3 Place 2 0 cm of BR 12 or PMMA on the breast platform centered laterally and extend ing 1 0 cm over the chest wall edge Place the AEC detector in the position closest to the chest wall 4 Place the AEC detector in the position closest to the chest wall Take an exposure develop the film then measure the optical density OD Note Always measure the Optical Density with the lower edge o...

Page 80: ...ensity values obtained in this procedure 5 11 kV Tracking Small Focal Spot Mo This procedure ensures that the automatic exposure control system will produce proper OD films at intermediate kV levels small focus with 4 0 cm of attenuation 1 Place 4 0 cm of BR 12 on the Magnification Table centered laterally positioned 1 0 cm over the chest wall edge 2 Set the unit for an Auto Time exposure Small fo...

Page 81: ... Optical Density Ensure the Optical Density reading is within 0 15 OD of the exposure at 6 0 cm If necessary repeat the entire procedure to bring both the 2 5 cm and the 6 0 cm exposures within the specified requirements 12 Change the Gain Offset and M Density if required values for each of the remaining small focal spot kV stations to the Gain Offset and M Density values obtained in this procedur...

Page 82: ...tical density of each film to ensure that it is within 0 15 OD of the mean optical density 3 If necessary make Gain and Offset adjustments Use absorber thicknesses to make Gain adjustments between 7 mAs and 10 mAs Use absorber thicknesses to make Offset adjustments between 70 mAs and 100 mAs Small Focal Spot 0 030 mm Molybdenum Filter Mag Table Paddle BR 12 KODAK MIN R 2000 Film Cassette Gain Lowe...

Page 83: ...e AEC detector in the position closest to the chest wall Take an exposure develop the film then measure the optical density OD 6 On Calibration Screen 2 select HTC FACTOR and adjust as necessary to set OD to match the OD reading from the 26 kV low attenuation exposure on Table 4 6 0 05 OD Record final results on Table 4 10 Table 4 10 HTC Factor Worksheet 5 17 Large Bucky 24 x 30 cm Factor Calibrat...

Page 84: ... Table 4 11 This is the Large Bucky Factor 10 On Calibration Screen 2 select LgBky FACTOR and adjust as necessary to match the calculated Large Bucky Factor 11 Take an exposure with the 24 x 30 cm Bucky and develop the film Measure the OD Adjust the Large Bucky Factor until the large Bucky OD is within 0 10 of the small Bucky OD Table 4 11 Large Bucky Factor Worksheet 5 18 Compression Thickness Th...

Page 85: ...re from Table 4 6 on the Bucky Reapply com pression then make a second exposure Record this mAs value as point B on the semi log worksheet 19 Draw a line between points A and B on the semi log Follow the left side of the graph and locate the 80 mAs point Draw a straight line and intercept the line between the 2 points 20 Draw a vertical line from that point to the bottom of the graph and note the ...

Page 86: ...al Chapter 4 Calibrations and Performance Checks Automatic Exposure Control System Calibration Table 4 12 Compression Thickness Threshold Semi Log 0 10 20 30 40 50 60 70 80 90 100 200 300 400 500 1cm 2cm 3cm 4cm 5cm 6cm mAs Thickness ...

Page 87: ...t 0 Place an obstruction padded chair table below C arm 2 Press and hold C arm down button until C arm moves onto obstruction 3 Verify C arm stops automatically If not perform the C arm Safety Microprocessor Board Calibration procedures as per Section 8 4 4 Check that all C arm down buttons are disabled 5 Verify Safety Switch alert appears on the display Alert Code 6 see Chapter 5 Section 3 2 Tabl...

Page 88: ...lowing are standard system performance checks Bucky Device Performance Section 6 6 AEC Limits Performance Check Section 6 7 System Level Functional Check Section 6 8 Optical Density User s Preference Verification Section 6 9 The following checks verify that the mammography unit s shielding meets requirements Perform the appropriate check s after servicing the Tubehead or the Image Receptor Support...

Page 89: ...s in Step 3 make another exposure and record the milliroentgen reading on the semi log 6 Repeat Step 5 with additional 0 1 mm sheets of aluminum between the x ray tube port and the radiation probe Record the milliroentgen reading on the semi log after each exposure until the reading is less than one half the original step 4 exposure reading without aluminum 7 Draw a line on the semi log through th...

Page 90: ...4 34 P N9 500 0255 Service Manual Chapter 4 Calibrations and Performance Checks Performance Checks Table 4 13 Half Value Layer Semi Log mR ...

Page 91: ...and 60 mAs Conduct a second exposure and record the milliroentgen reading on the Work sheet 5 Continue to randomly change the technique settings for kV and mAs then return to 25 kV and 60 mAs and take an exposure Record the milliroentgen reading on the work sheet until ten individual readings have been recorded 6 Compute and record the average milliroentgen reading Subtract each actual reading fro...

Page 92: ...by 9 Take the square root of the result 5 Divide the number obtained in Step 4 by the average milliroentgen reading The quotient or coefficient of variation must be less than 0 05 6 If the coefficient of variation greater than 0 05 check the calibration of the Automatic Exposure Control System 6 4 Reproducibility in Auto kV Mode The following test verifies that the automatic exposure control syste...

Page 93: ... record the milliroentgen readings for each exposure 4 Calculate the average milliroentgen reading Subtract each actual reading from the aver age Square each difference Add the squares and divide their sum by 9 Take the square root of the result 5 Divide the number obtained in Step 3 by the average milliroentgen reading The quo tient called the coefficient of variation must be less than 0 05 Note ...

Page 94: ...4 38 P N9 500 0255 Service Manual Chapter 4 Calibrations and Performance Checks Performance Checks Table 4 14 Reproducibility Worksheet ...

Page 95: ...P N 9 500 0255 4 39 Service Manual Chapter 4 Calibrations and Performance Checks Performance Checks Table 4 15 Linearity Worksheet ...

Page 96: ...veloped film 5 Place 5 0 cm of BR 12 or PMMA acrylic on the Bucky and hold it in place with the paddle Reload the same cassette with the same film type then load it into the same Bucky 6 Make an exposure using the technique factors from Step 1 Verify a high mAs reading is obtained nominally between 200 and 400 mAs dependent on film speed If the mAs reading is above or below the specified range add...

Page 97: ...nsity Users Preference Verification This procedure verifies that the system falls within the users preference for optical density 1 Remove any meter scope or probe from the machine that was used in any procedures prior to beginning this verification 2 Install the Bucky with a loaded cassette on the IRSD 3 Place the ACR Phantom on the IRSD centered laterally and positioned 1 0 cm back from the ches...

Page 98: ...mR reading If the reading is greater than 0 10 mR contact LORAD Technical Support 5 Repeat this entire procedure for positions B C and D in Figure 4 8 6 Install the 24 x 30 cm Bucky if used Repeat this test for positions E F G and H Figure 4 8 for the 24 x 30 cm Bucky 7 If there are any readings greater than 0 10 mR contact LORAD Technical Support 6 11 X ray Tubehead Leakage Check This check is pe...

Page 99: ...e unit for a Manual mode exposure at 39 kV 220 mAs Large focal spot Conduct an exposure and record the mR reading 5 Make exposures using the same technique fac tors for positions B through H Figure 4 9 Record each mR reading For position H rotate the C arm to position the probe directly behind the tubehead Be sure the distance between the probe and the focal spot remains exactly one meter for each...

Page 100: ...gnment Template LORAD P N 3 405 8010 shown in Figure 4 10 must be positioned on the unit s image receptor support on top of a 14 x 17 cm cassette screen Lanex Med The visible borders of the x ray field can be compared with graduations on the template to determine coarse x ray field alignment The template contains minimum and maximum borders for the left right and rear field edges of the 18 x 24 cm...

Page 101: ...rmal capacity of the tube during this procedure Since it is necessary to make repetitive exposures the system can be set so that there is only a fifteen second Standby interval between exposures On the Microprocessor Board set DIP Switch S2 switch 1 to ON Remember to set this switch to OFF at the end of this procedure Below is the recommended method to use when making exposures and determining req...

Page 102: ...phy unit Note Not all apertures are standard equipment on the Affinity Perform the sections applicable to the apertures packaged with the unit 4 Adjust the Affinity apertures shown in Figure 4 12 in the order shown below Section 7 4 Auto Aperture Alignment Section 7 5 Magnification Full Field 18 x 24 cm Aperture Alignment SM FS Section 7 6 10 cm Coned down Contact Aperture Alignment LG FS Section ...

Page 103: ...uto Aperture Alignment The Auto Aperture Figure 4 12 is used for 24 x 30 cm and 18 x 24 cm Large Focal Spot exposures and is aligned as follows 7 4 1 Align the 24 x 30 cm Large Focal Spot Note The Auto Aperture must be retracted for this procedure by placing a 24 x 30 cm Cassette Sensor Simulator on the breast tray Use the Image Receptor Phantom Tool PN 9 060 0403 or if not available strips of ref...

Page 104: ...eft and rear edges of the blade to align within the markings on the alignment template 12 Tighten the four outer screws securing both shields to the upper and lower aperture plates 13 Verify the beam position again to ensure the blades did not move when tightening the hardware 7 4 2 Align the 18 x 24 cm Large Focal Spot 1 Remove the Auto Aperture from the tubehead slot 2 Remove the 24 x 30 cm Cass...

Page 105: ...ays use the motor control SW1 on Tubehead Control Board to move around each axis C If the back edge field adjustment is off reposition by relocating the auto aperture sensor to match the new location of the rear edge of the aperture Cycle the IN OUT position of the auto aperture by using SW1 on the Tube head Control Board take exposures and verify position D Making exposures as necessary adjust th...

Page 106: ...e 7 Tighten the two inner screws securing the lower shield to the aperture base plate 8 Remove the Auto Aperture from the tubehead slot 9 Replace the top plate and left alignment blade Leave the screws loose enough so mini mal effort is required to move the blade 10 Slide the Auto Aperture into the tubehead slot 11 Make exposures as necessary to adjust the left and rear edges of the blade to align...

Page 107: ... the upper and lower aperture plates 5 Verify the beam position again to ensure that the blades did not move when tightening the hardware 6 Remove the alignment template when completed 7 9 X ray Field Alignment Verification 1 Install the X ray Beam Alignment Template as per Section 7 1 2 For each aperture see Figure 4 12 make an exposure at 3 22 kV 4 16 mAs 5 applicable focal spot 6 Develop the fi...

Page 108: ...y image area may indicate aperture plate mis alignment 7 Remove the auto aperture and the Bucky device Install the 18 x 24 cm Small Focal Spot Aperture refer to Figure 4 12 then position the X ray Beam alignment template Figure 4 10 on the IRSD Select the Small focal spot then press the light field lamp button Compare the edges of the light field 18 x 24 cm Small Spot to the markings on the tem pl...

Page 109: ...ay field complies to the performance standard set forth by FDA 21CFR Always perform this test with the ambient light reduced darken the room The following equipment is required for this test Light Detector Model 268P Light Meter UDT Instruments Model 351 Aluminum Aperture 1 0 mm diameter or equivalent 1 Place the probe of a light detector on the IRSD and center it Place the aluminum aper ture dire...

Page 110: ...e inside lux value I1 Move the probe 3 0 mm from the edge of the defined light field away from the center of the field Reposition the aluminum filter press the light field switch then record the outside lux reading I2 4 Subtract both edge readings from the ambient reading and record each of the differences IA I1 D1 and IA I2 D2 5 Divide the inside difference by the outside difference and record th...

Page 111: ...m the Light Field lux value Record the difference 4 Repeat this Illuminance test for positions B C and D in Figure 4 16 5 If the difference in any quadrant is less than 160 lux the Light Field Illuminance Test is considered failed 6 If necessary remove the lower tubehead cover then loosen the two screws that secure the lamp socket to the lamp cradle Figure 4 17 7 Increase the light field illumi na...

Page 112: ...r as per Chapter 6 Section 3 3 1 6 Remove the C arm upper rear cover and the C arm top cover as per Chapter 6 Section 3 1 2 7 Move the compression device up completely 8 Loosen the Dog Point Set Screw Figure 4 18 Item 1 The set screw is loosened from the bottom of the compression device 9 Loosen the two lock nuts Fig ure 4 18 Item 2 of the chain tension assembly then evenly turn the adjustment scr...

Page 113: ...sembly until it bottoms out then make one full turn of the pot in a clockwise direction 4 Thread the timing belt through the pulleys ensuring the potentiometer does not move and the timing belt does not twist 5 Insert the timing belt through the upper clamp block refer to Figure 6 35 Apply Blue Loctite 242 and tighten screws 6 Loosen screws securing timing belt in lower clamp block While holding o...

Page 114: ...er TP16 TPY to TP17 TPX 4 Install the 18 x 24 cm large focus aperture and the 18 x 24 cm compression paddle Remove all other C arm accessories image receptors magnification accessory etc 5 Apply power to the unit The C arm Safety Microprocessor is automatically set to accept calibration data Verify that the CAL LED D5 on the board illuminates 6 When startup sequence has finished press the Cal Set ...

Page 115: ...Verify jumper J7 on the HV Control Filament PCB is installed refer to Appendix B Sec tion 6 0 Table B 24 HV Control Filament Board PN 1 003 0485 Jumper Settings 6 Turn the unit ON 7 Access Calibration Screen 3 Figure 4 19 highlight the kV field 8 On the Control Panel press the Reset and Comp Release buttons simultaneously The screen will update to show the Adjust kV Offset prompt in the message ar...

Page 116: ...4 60 P N9 500 0255 Service Manual Chapter 4 Calibrations and Performance Checks Maintenance Procedures ...

Page 117: ...ble 5 1 In addition each time the Affinity Mammography System is down for service 1 The unit should be inspected for Cleanliness Loose or missing panels or covers and Loose or frayed wires or cables 2 The Alert Codes Log should be checked for existing fault conditions as per Section 3 2 3 Correct any problems found prior to returning the unit to operations Upon removing and replacing major compone...

Page 118: ...of the following sub systems Operator Control Power Distribution System Control Tubehead Functions X ray Tube Control Mechanical Functions Exposure Control Automatic Exposure Control 3 1 1 Operator Control Panel The Operator Control Panel is a microprocessor based unit that communicates bi directionally with the Host Microprocessor Board via RS 422 differential I O Input Frequency PM Refer to D AR...

Page 119: ... of 220 230 VAC nominal 50 60 Hz single phase power A line filter is utilized to reduce RFI ENC emissions and susceptibility to noise The toroidal transformer isolates the incoming power and multiple voltages are derived from the secondary windings These voltages are rectified and regulated then distributed throughout the unit There is a power on surge circuit to limit the inrush current The x ray...

Page 120: ...ly motions Mirror Auto Aperture Lamp and Filter movements and reports to the Host Microprocessor the status position of each movement The removable apertures are encoded with a 4 bit word and this information is communicated to the Host Microprocessor These functions are all processed by the Host microprocessor and must match a valid condition before an exposure may be initiated This PCB also supp...

Page 121: ...s used to shut down the HV drive There is also a HV divider within the multiplier that returns the voltage value as a feedback signal to control the HV during the exposure An additional HV connector is available for external measurement of the actual HV An analog signal is applied to the Power Control PCB from the Host microprocessor which represents the kV value selected by the technique This val...

Page 122: ...ernally to the C arm assembly This strain gauge signal is processed by the C arm Safety PCB and inhibits downward motion upon the sensing of approximately 154 N 35 lb 3 1 7 Exposure Control The exposure function is controlled by the Host microprocessor Several inputs are monitored and must be correct before an exposure may be initiated These include a valid combination of image receptor and apertu...

Page 123: ...uto Filter This mode provides full automatic operation of all technique factors 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 AutoFILTER algorithm the exposure is momentarily interrupted and the Rhodium filter is moved into the beam in place of t...

Page 124: ...al power up Initialization is stopped until the 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_EXCEEDS_MAX EXP BACKUP AEC algorithm predicts exposure will exceed the programmed maximum exposure mAs 3 XRAY_SWITCH_NOT_RELEASED X R...

Page 125: ... C ARM SWITCH C Arm switches 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 Communica tion Communication fails between Host and Control Panel 71 MIRROR_FAULT MIRROR Mirror detected as not moving away from X ray field during an X ray expo sure attempt 72 FILTER_ERROR FILTER Incorrect filter position 73 TUBEHEAD_COM...

Page 126: ...the Null Modem Cable as shown in Figure 5 1 85 BOOST_TUBEHEAD_COMM_ERROR SYSTEM ERROR During boost Host board is unable to communicate with Tubehead Controller 86 AF_EXPOSURE_TUBEHEAD_COMM_ERRO R SYSTEM ERROR During Auto Filter Exposure Host board is unable to communicate with Tube head Controller 90 FLASHER_COMM_ERROR AUTO ID Flasher does not respond 92 PRINTER_NO_PAPER_ERROR PRINT NO PAPER 93 PR...

Page 127: ...AL DATA option in the Special command field When selected and initiated this field will reset all calibration data 2 Press Reset Comp Rel to access the Alert Codes Log 3 The title of the log of records and CMD line will appear on the display screen along with the first page of alert codes Use scroll keys to view the log 4 Select using the change keys the DOWNLOAD command 5 Press Reset Comp Rel to ...

Page 128: ... select Transfer Capture Data Stop Verify that the data downloaded correctly by examining the text file established in Step 2 5 From the computer the log can now be printed or appended 3 3 3 Uploading Calibration Data 1 On the HyperTerm s File Properties Settings Ascii Setup menu configure the HyperTerm for 300 ms line delay and 1 ms character delay 2 At the Affinity Control Panel Calibration Scre...

Page 129: ... one Warning Service engineers must take appropriate radiation safety measures when testing or maintaining the unit Caution Always observe Electrostatic Discharge ESD precautions when working with electronics and electronic components Note When servicing the Affinity if a procedure instructs you to remove any covers or panels do not replace the covers until all required procedures e g calibrations...

Page 130: ...bly 4 Power Control Board 5 Auxiliary Power Distribution Board 6 Host Microprocessor Board 7 Communications Interface Board 8 Low Voltage Power Supply 9 C arm Safety Board 10 Main Circuit Breaker 11 C arm Angle Detent Microswitch 12 C arm Rotation Potentiometer 13 C arm Actuator Assembly 14 Operator Control Panel Control Unit Assy 15 Force Load Cell Vertical Drive Figure 6 1 Gantry Components 1 2 ...

Page 131: ... panel removal to gain access to the interior of the unit Refer to this section for all Gantry cover removal procedures Be sure to turn the unit OFF and remove the power cord if applicable before removing the covers Legend for Figure 6 2 1 Right side Cover 2 Left side Cover 3 Upper Rear Panel 4 Rear Connector Panel with Shroud installed 5 Lower Rear Panel Power Distribution Assembly Figure 6 2 Gan...

Page 132: ...ng top of side cover 5 Slide the cover upward until the tabs on the cover clear the mounting slots in the Gantry frame 6 Pull the cover slightly away from the unit then set it upright on the floor Note that a wiring harness connected to the Angle Display Board and the Emergency Off Switch is still attached to the Gantry Proceed to Step 8 if side panel is to be replaced 7 Do not perform steps 8 and...

Page 133: ...ting hardware 5 Reverse these procedures to replace the panel 2 1 4 Lower Rear Panel Power Distribution Assembly The lower rear panel Figure 6 3 Item 3 which is part of the Power Distribution Assembly chassis provides access to the isolation transformer and the C arm actuator assembly The panel and Power Distribution Assembly chassis slide out of the unit together The Power Distribution Assembly c...

Page 134: ... arm Angle Display Board and disconnect it 3 Remove the two mounting screws that secure the Display Board to the cover Pull the board off of the spacers Note that the two spacers between the board and the mounting holes can be removed 4 Position the replacement C arm Angle Display on top of the spacers Secure the board and spacers with the previously removed hardware 5 Make the wire harness connec...

Page 135: ...emoval procedures for all EMO switches are identical see Figure 6 5 1 Remove power to the unit Remove the left or right side Gantry cover which ever is appropriate 2 Cut the Tie Wrap wrap that secures the switch harness to the rear of the switch Pull the wires off of the terminals note each terminal position 3 Remove the connector housing Unscrew the plastic lock nut from the switch and remove it ...

Page 136: ...sor Board and the Control Panel LCD Display see Figure 6 6 This section contains the procedures to remove and replace the internal components of the Affinity Series Control Panel Caution Always observe Electrostatic Discharge ESD precautions when working with electronics and electronic components Legend for Figure 6 6 1 Display Microprocessor Board 2 LCD Display Figure 6 6 Control Panel Components...

Page 137: ...the replacement chip into the socket Be sure to line up the dot on the chip with the arrow in the socket Skip to Step 9 6 Disconnect the keypad ribbon cable from the jack at BJ3 Disconnect the display back light cable from BJ6 7 Remove the four screws that secure the Microprocessor Board to the front cover Lift the board off the cover then disconnect the display data cable from BJ2 on the opposite...

Page 138: ...king with electronics and electronic components Note The HV Generator is assembled calibrated and complied at the factory as an assembly and must be replaced as an assembly The type of mounting plate used with the HV Generator Assembly determines the remove and replace procedures used Affinity Mammography Systems with a Serial Number between xxxmmyy0001 and xxxmmyy0018 xxx represents the system se...

Page 139: ...able receptacle C On the HV Inverter board disconnect GJ1 Wait approximately 6 minutes before proceeding see WARNING below WARNING To reduce the risk of hazardous electrical shock do not attempt service until the LEDs D2 Inverter Rail and D35 Brake Rail on the HV Inverter Board are extinguished this will take approximately 5 minutes Once the LEDs are extinguished do not proceed until an additional...

Page 140: ...Remove board from standoffs and set aside H Remove the 13 screws securing the HV Inverter board to the standoffs on the mounting plate Remove board from standoffs and set aside I Locate and remove the 5 phillips screws securing the lower portion of the mounting plate to the Gantry frame Legend for Figure 6 7 1 HV Multiplier 2 HV Inverter Board 3 HV Control Filament Board 4 HV Cable Receptacle 5 Ri...

Page 141: ...ilament board to the stand offs on the mounting plate Remove board from standoffs and set aside F Remove the 13 screws securing the HV Inverter board to the standoffs on the mounting plate Remove board from standoffs and set aside G While maintaining a secure hold position the HV Generator Assembly mounting plate flush against the Gantry frame Secure upper portion of the mounting plate in position...

Page 142: ...EDs D2 Inverter Rail and D35 Brake Rail on the HV Inverter Board are extinguished and an additional 1 minute has elapsed 4 On the HV Inverter board disconnect GJ3 and GJ5 Remove any installed cable ties 5 On the HV Control Filament board disconnect MJ4 MJ5 MJ6 MJ7 and MJ8 6 Loosen the uppermost mounting screws securing the HV Generator Assembly mounting plate to the Gantry 7 While maintaining a se...

Page 143: ...Procedures Gantry Components Remove and Replace Legend for Figure 6 8 1 HV Multiplier 2 HV Inverter Board 3 HV Control Filament Board 4 HV Cable Receptacle 5 Uppermost Mounting Screws 2 6 Mounting Plate new style Figure 6 8 HV Generator Assembly new style mounting plate Removal ...

Page 144: ...ffs 5 Reverse procedures to replace the Power Control Board 6 Perform the following procedures before returning unit to service Chapter 3 Section 2 3 Post Power Up Checks 2 4 3 Auxiliary Power Distribution Board The Auxiliary Power Distribution Board is located at the bottom of the left side Gantry frame 1 Remove power to unit and access the Power Distribution Board by removing the left side Gantr...

Page 145: ... necessary to replace the calibration storage battery skip to step 7 now If it is only necessary to replace the firmware chip U29 skip to step 8 now 3 Remove all of the wire harness connectors from their jacks at AJ2 AJ3 AJ5 AJ6 AJ8 AJ11 AJ13 AJ14 AJ16 AJ20 AJ27 AJ28 AJ29 AJ31 and AJ32 4 Remove the data ribbon cables from their connectors at AJ12 AJ22 AJ23 and AJ25 5 Lift the board off of the 7 sq...

Page 146: ...rrow in the socket 2 5 3 Communications Interface Board The Communications Interface Board is mounted to the right side Gantry frame just below the Microprocessor Board 1 Remove power to unit and access the Communications Interface Board by removing the right side Gantry cover as per Section 2 1 1 2 Remove the wire harness connectors from their jacks at EJ1 through EJ16 and at EJ19 3 Lift the boar...

Page 147: ... A On the Host Microprocessor Board connect the negative lead to TP10 AGND connect the positive lead to TP18 5 V B On the DMM you should read 5 10 V 01 V if not adjust the 5 V potentiometer on the LVPS 2 5 5 C arm Safety Microprocessor Board The C arm Safety Microprocessor Board is mounted to the right side Gantry frame near the bottom 1 Remove power to unit and access the C arm Safety Microproces...

Page 148: ...cuit Breaker is accessed by removing the upper rear Gantry panel 1 Remove power to unit and access the Main Circuit Breaker by removing the upper rear Gantry panel as per Section 2 1 2 2 Remove the 4 screws that secure the Circuit Breaker to the mounting bracket see Figure 6 10 3 Pull the Circuit Breaker out and disconnect the six wires from the lugs on the rear of the relay Note each wire color l...

Page 149: ... switch to the switch plate Note that the mounting holes through the switch plate are slotted to provide switch adjustment Figure 6 11 C arm Detent Microswitch Removal 5 Plug the 2 previously removed power wires onto their respective lugs on the replacement microswitch Install the new switch but do not tighten the mounting screws 6 Plug the unit in and apply power With the C arm still at the verti...

Page 150: ...e mounting bracket Pull the potentiometer out of the mounting bracket 6 Secure the replacement potentiometer onto the mounting bracket using the previously removed lock washer and hex nut 7 Install the clamp and sprocket previously removed onto the potentiometer shaft 8 Strip and tin the tips of the three wires previously cut then solder them to their respective posts on the potentiometer 9 Loosel...

Page 151: ...eft as seen from the rear of the Gantry as shown in Figure 6 13 Figure 6 13 Shipping Collar Installation of VTA Rail 2 Lower the C arm until it stops on the collar 3 Remove hub nut screws Figure 6 14 Item 11 and lower hub nut Figure 6 14 Item 9 by hand 4 Turn the system Off 5 Unplug the 4 pin connector from the C arm drive actuator motor 6 To release the lower portion of the actuator Figure 6 14 I...

Page 152: ...e clevis pin through the holes then replace the spring clip to secure the clevis pin 14 Thread the hub nut along the lead screw until its top surface is approximately 5 5 8 from where the lead screw enters the motor assembly 15 Plug the 4 pin connector into the motor 16 Turn the unit ON 17 Hold the hub nut to prevent it from turning then press a C arm UP button to run the hub nut up the lead screw...

Page 153: ...he standoff on the isolation mount Finally lower the jam nut one complete turn 20 Secure the jam nut bracket to the standoff on the isolation mount using a button head screw then tighten the screw that secures the bracket to the jam nut 21 Grease the lead screw then remove the shipping collar installed previously 22 Reinstall all previously removed covers and panels 23 Perform the following calibr...

Page 154: ...1 Tubehead Components Section 3 2 Compression Assembly Section 3 3 Image Receptor Support Device Components Section 3 4 Use the following legend and illustration as a guide for parts identification on the C arm Frame refer to Figure 6 15 Legend for Figure 6 15 1 Patient Handle 2 Filament Protection Board 3 3 Position Switch Board 4 7 Position Switch Board 5 C arm Switch Interface Board 6 C arm Acc...

Page 155: ... 6 16 Legend for Figure 6 16 1 X ray Tube 2 Filament Protect Board 3 C arm Cooling Fan 4 Aperture Detect Board part of Beam Limiting Assembly 5 Filter Shifter Assembly part of Beam Limiting Assembly 6 Filter Position Detectors part of Beam Limiting Assembly 7 Light Field Lamp Assembly part of Beam Limiting Assembly 8 Motorized Mirror Assembly part of Beam Limiting Assembly 9 Tubehead Control Board...

Page 156: ...uide for parts identification on the Compression Device refer to Figure 6 17 Legend for Figure 6 17 1 Compression Motor Brake Assembly 2 Compression Clutch Clutch Brake Assembly 3 Compression Force Thickness Display Board 4 Compression Tray Board 5 Compression Thickness Potentiometer 6 Compression Timing Belt 7 Compression Chain Figure 6 17 Compression Device Components ...

Page 157: ...dures for the components on the C arm Frame The alignment adjustment and or calibration procedures are provided as required 3 1 1 Patient Face Shield Installation and Removal The Face Shield Figure 6 19 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 follow ...

Page 158: ...et it aside C arm Top Cover 1 Remove the decorative caps from the screw access holes on the C arm Top Cover Figure 6 20 Item 2 2 Loosen the screws then slide the cover back and off the C arm 3 Disconnect the 3 position switch wiring harness Figure 6 20 Item 3 from the switch pad on the cover C arm Bottom Cover 1 Remove the decorative caps from the screw access holes on the C arm Bottom Cover Figur...

Page 159: ...Figure 6 20 Item 7 to the C arm frame 3 Disconnect the ground wire from the lower rear cover 4 Pull the lower rear cover down approximately one inch until the spring clips disengage 5 Pull cover away from the unit frame Legend for Figure 6 20 1 Patient Handle 2 C Arm Top Cover 3 3 Position Switch Wiring Harness 4 C Arm Bottom Cover 5 C Arm Side Covers 2 Left and Right 6 7 Position Switch Wiring Ha...

Page 160: ...the unit Remove the C arm Top Cover as per Section 3 1 2 2 Disconnect the wire harness from the 3 position C arm Switch Pad on the Top Cover 3 Locate the Filament Protection Board on the C arm Frame Disconnect the wire harness connectors from their jacks 4 Remove the 4 screws that secure the board to the standoffs on the C arm frame then lift the board out of the unit See Figure 6 21 5 Install the...

Page 161: ...ply Power then perform the Tubehead Controls Functional Checks as per Chapter 3 Table 3 1 Post Power Up Checks 3 1 5 7 Position Switch Board The C arm houses four 7 Position C arm Switch Boards two on each side of the C arm The boards which are membrane type switch pads mount to the C arm Side Covers using an adhesive backing 1 Remove power from the unit Remove the C arm Bottom Cover as per Sectio...

Page 162: ...l the replacement C arm Switch Interface Board When complete perform the C arm Switch Functional Check as per Chapter 3 Table 3 1 Post Power Up Checks 3 1 7 C arm Accessory Detect Board The C arm Accessory Detect Board refer to Figure 6 23 is mounted to the C arm frame and is accessed by removing the Left Side C arm Cover This circuit board which houses two optical sensors detects when a magnifica...

Page 163: ...limiting device Alignment adjustment or calibration instructions are provided 3 2 1 Tubehead Covers The x ray tubehead enclosure is comprised of an upper cover and a lower cover Figure 6 24 The lower cover must be removed first 1 Remove power from the unit Remove the aperture if installed from the slit in the tubehead 2 Remove the screw that secures the front of the lower cover This screw is acces...

Page 164: ...n quick disconnect 4 Unscrew the filament connector from the receptacle on the rear of the x ray tube 5 Remove the 2 screws that secure the rear of the tube to the mounting cradle on the tubehead chassis 6 Remove the 4 mounting screws that secure the x ray tube to the front of the tubehead chassis These screws are accessed from below through the beam limiting assembly Lift the tube out of the unit...

Page 165: ...ction 6 5 Reproducibility in Auto Filter Mode Section 7 0 X ray and Light Field Check and Alignment Procedures Section 5 1 AEC Detector Gain Calibration 3 2 2 1 Exposure Counter Reset The Affinity Series keeps track of the number of exposures made Whenever the x ray tube is replaced it will be necessary to clear or reset the exposure counter to accurately tabulate the number of exposures made with...

Page 166: ...d Control Board Figure 6 26 Note locations Figure 6 26 Tubehead Control Board Removal 3 Remove the five screws that secure the Tubehead Control Board to the standoffs on the tubehead chassis 4 Pull the board out of the unit 5 Reverse procedures to replace the board Skip to Step 7 6 Replace the Firmware Chip U9 as per Section 2 5 2 Firmware Replacement then go to Step 7 7 Verify the board operation...

Page 167: ...d mirror assemblies move back in F Press S3 verify the filter select mechanism changes position G Press S4 verify the entire collimator assembly cycles in and out of field Table 6 1 Tubehead Control Board Push Button Switches 8 Turn power OFF replace all covers and return to service Switch Function S1 Auto Aperture Select S2 Light Field Lamp Assy Motorized Mirror Assy Select S3 Filter Select S4 Co...

Page 168: ...em 3 Note the locations if they are not labeled 3 Remove the Filament Protect Board as per Section 3 1 3 Steps 2 through 4 4 Remove the 2 screws Figure 6 27 Item 2 that secure the fan mounting bracket Figure 6 27 Item 1 to the C arm Top Plate Pull the fan out of the unit 5 Install the replacement cooling fan by reversing this procedure Ensure the air flow is as shown in Figure 6 27 View B 6 Before...

Page 169: ... tubehead covers as per Section 3 2 1 2 Disconnect the wiring harness from the Tubehead Control Board Figure 6 26 Note location 3 Remove the 2 mounting screws that secure the board to the tubehead chassis Pull the board out of the unit 4 Reverse this procedure to install the replacement Aperture Detect Board Do not replace the tubehead covers at this time 5 Verify that the optical sensors on the b...

Page 170: ...t to the tubehead frame These screws are accessed from the right side of the tubehead frame 4 Slide the assembly out from the right side Use care not to damage the filters or other collimator components lamp mirror etc 5 Reverse this procedure to install the replacement Filter Shifter assembly 6 Verify that the Filter Shifter motor functions A Press S4 on the motor control board and check that the...

Page 171: ...Item 2 disconnect the fan power cable 4 Disconnect the Light Field Lamp Assembly wiring harness from the Tubehead Control Board Figure 6 16 Item 9 5 Loosen and remove the 4 mounting screws Figure 6 30 Item 3 that secure the Light Field Lamp Assembly to the tubehead frame 6 Slide the assembly out taking care not to damage the lamp or other collimator components mirror filter etc 7 Reverse this proc...

Page 172: ...m the following procedures prior to releasing the unit to the user Section 7 11 Light Field Edge Contrast Check Section 7 12 Light Field Illuminance Check 3 2 10 Light Field Lamp Assembly Fan Replacement The Light Field Lamp Assembly Cooling Fan is mounted to the rear bracket of the Light Field Lamp Assembly directly in front of the Tubehead Control Board 1 Remove the lower tubehead cover as per S...

Page 173: ...in the mounting bracket and secure it with the previously removed hardware 5 Connect wiring harness to the Tubehead Control Board as noted in Step 2 above 6 Apply power to the unit 7 On the Tubehead Control Board Figure 6 26 push S4 to cycle the mirror assembly completely forward so that the flag blocks the front sensor Verify that D8 on the Tubehead Control Board illuminates momentarily 8 Push S2...

Page 174: ...sion Brake Compression Tray Sensor Board Compression Force and Thickness Boards 3 Disconnect the wiring between the covers and the Compression Device including 1 ground wire for each cover 4 Reverse procedures to replace the Compression Device Covers 3 3 2 Compression Motor Brake Assembly The Compression Motor assembly is mounted on a rail inside the C arm frame near the bottom Access to this asse...

Page 175: ...mpression motor then disconnect them Pull the motor out from the mounting plate until the motor shaft clears the plate then pull the motor out from the C arm 7 Transfer the mounting plate to the new motor then reverse this procedure to install the replacement motor assembly 8 Apply power and verify that the motor works by cycling the motor in each direction using the compression controls Figure 6 ...

Page 176: ...rness 7 Install the replacement clutch brake and tighten the mounting screws Connect the clutch brake harness to the main wiring harness 8 Slide the clutch shaft into the compression device from the left side until the shaft end protrudes through the opening in the clutch brake Slide the brass spacer raised edge first over the shaft and into the brake 9 Place the armature on the end of the replace...

Page 177: ... Remove and Replace Procedures C Arm Components Remove and Replace Legend for Figure 6 33 1 Clutch Shaft 2 Clutch Brake Magnet Assembly 3 Brass Spacer 4 Slip Clutch 5 Compression Knob 6 Locking Bar Figure 6 33 Compression Clutch Clutch Brake Assembly Removal ...

Page 178: ...e steps to install the replacement display board 5 Perform the following before releasing the unit to the user Chapter 4 Section 3 1 Compression Force Calibration Chapter 4 Section 3 2 Compression Thickness Calibration Figure 6 34 Compression AEC Position Display Boards Removal 3 3 5 Compression Tray Sensor Board The Compression Tray Sensor board Figure 6 17 Item 4 is mounted to the compression de...

Page 179: ... turn potentiometer that mounts to the left side bulkhead of the compression device frame 1 Turn power OFF 2 Remove any installed compression accessory 3 Remove the C arm bottom cover and the left side cover as per Section 3 1 2 4 Remove the Tubehead covers as per Section 3 2 1 5 Remove the top and bottom compression device covers Section 3 3 1 Use care not to damage the compression device bellows...

Page 180: ...ck Assembly 7 Gently thread timing belt down and out of the pulleys Check timing belt if damaged replace as follows A Remove the IRSD covers as per Section 3 4 1 B Through the rear of the IRSD and under the bellows assembly locate and loosen two screws securing the belt in the lower clamp block Remove belt and discard C Insert the new belt through the lower clamp on the Tubehead Support Plate Tigh...

Page 181: ...y 2 Lower Clamp Block Figure 6 36 Removal of Timing Belt from Bearing Block Assembly 8 Locate 3 colored wires soldered to potentiometer Note the colored wire for each post and desolder wires Refer to Figure 6 37 Figure 6 37 Compression Thickness Potentiometer Removal 9 Remove screws from potentiometer bracket and pull from compression device 1 3 4 2 5 Pin 2 Pin 1 Pin 3 ...

Page 182: ... assembly upper and lower covers the C arm bottom cover and left side cover 15 Replace the compression accessory Restore power to unit 3 4 IRSD Components This section details the removal and replacement procedures for the components inside the image receptor support device IRSD The alignment adjustment and or calibration procedures are provided as required 3 4 1 Image Receptor Support Device Cove...

Page 183: ...RSD top plate If the AEC Detect board fails replace the AEC Detector Assembly Access to this component requires removal of the IRSD covers 1 Turn power OFF Remove the IRSD covers as per Section 3 4 1 then flip the top plate over to access the detector board 2 Remove the D sub connector from the rear of the sensor assembly 3 Loosen and remove the two screws one on either side that secure the shroud...

Page 184: ...move the two screws that secure the board to the AEC sensor slide rail Lift the board off the slide rail 4 To install the replacement AEC Position Detect board reverse these steps 5 Apply power to the unit Slide the AEC sensor to all seven detent positions Verify that for each detent the corresponding LED on the compression device display lights 6 To install the replacement AEC Sensor board revers...

Page 185: ...D frame then apply power and enter the Run Mode Using the Image Receptor Phantom Tool PN 9 060 0403 or reflective tape block the detectors according to the reference table in Appendix B Table B 19 Verify that the image receptor status on the LCD display changes appropriately 6 To install the replacement AEC Sensor board reverse these steps When complete perform the procedures listed below before r...

Page 186: ...overs and go to Step 6 3 Disconnect all cables and ground wires to the AEC Position Compression Display Microprocessor Board Figure 6 41 Item 1 4 Remove the four nuts securing the board to the IRSD bottom plate 5 To install the replacement AEC Position Compression Display Microprocessor Board reverse these steps 6 When complete perform the procedures listed below before releasing the unit to the u...

Page 187: ...the compo nent location within the system The Item number is given when applicable Refer To identifies the Chapter and Section within the Service Manual to go to for instal lation or remove and replace procedures for that part Table 7 1 Gantry Cover Control Panel and Internal Components Parts List Part Number Description Fig Item Refer To 1 003 0360 Assy C Arm Angle Display Figure 6 1 1 Chapter 6 ...

Page 188: ... 3 Chapter 6 Section 3 1 4 1 092 0024 Keyboard Membrane 2x3 Upper Left Figure 6 15 4 Chapter 6 Section 3 1 5 1 092 0026 Keyboard Membrane 2x3 Lower Left Figure 6 15 4 Chapter 6 Section 3 1 5 1 092 0025 Keyboard Membrane 2x3 Upper Right Figure 6 15 4 Chapter 6 Section 3 1 5 1 092 0027 Keyboard Membrane 2x3 Lower Right Figure 6 15 4 Chapter 6 Section 3 1 5 1 003 0436 Assy Switch Interface PCB Figure...

Page 189: ...r Round 12 x 75 LG Figure 6 34 3 Chapter 6 Section 3 3 3 2 155 0006 Clutch Slip Comp Dev Figure 6 34 4 Chapter 6 Section 3 3 3 3 251 0026 Compression Knob Qty 2 Figure 6 34 5 Chapter 6 Section 3 3 3 1 003 0472 Assy AEC Pos Comp Display Bd right Figure 6 17 3 Chapter 6 Section 3 3 4 1 003 0473 Assy AEC Pos Comp Display Bd left Figure 6 17 3 Chapter 6 Section 3 3 4 1 003 0103 Assy Comp Tray Sensor P...

Page 190: ...e 7 5 cm Spot Magnification Figure 4 12 4 Chapter 4 Section 7 3 3 000 5085 Aperture Mag Full Field Figure 4 12 5 Chapter 4 Section 7 3 3 000 3121 Bucky 18 x 24 cm Front Load Cassette Holder N A N A 4 000 0241 Bucky 18 x 24 cm HTC Bucky N A N A 4 000 0242 Bucky 18 x 24 cm SRL 2000 Grid System N A N A 4 000 0243 Bucky 24 x 30 cm HTC Bucky N A N A 4 000 0244 Bucky 24 x 30 cm SRL 2000 Grid System N A ...

Page 191: ...ed 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 Maximum Standby Power 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...

Page 192: ... that are not grounded A level of 8 kV for air discharge to all accessible parts IEC 601 1 2 EMI Susceptibility System is immune from levels of 1 v m for the frequency range of 26 MHz to 1 GHz IEC 601 1 2 EMI Generation Limits System complies with the requirements of IEC 601 1 2 for conducted and radiated emission Input Line Surge fast transient burst lightning IEC 601 1 2 Maximum Heat Dissipation...

Page 193: ...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 Compres sion 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 wit...

Page 194: ...Accuracy 0 5 cm between 0 5 cm and 15 cm at 132 N 30 lb compression force The measurement is reproducible within 2 0 mm of the displayed value Compression thickness is displayed on the compression device and is angled and visi ble from both sides of patient 1 7 Compression Paddles Compression Paddles The compression paddles are transparent and the full field paddles are marked with the loca tion o...

Page 195: ...en tested with the compression paddle placed above the breast support surface at a distance equivalent to standard breast thick ness The shadow of the vertical edge of the compression paddle is not visible on the image 1 8 Apertures There are six 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 ...

Page 196: ...witches 1 12 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...

Page 197: ...ation 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 ex...

Page 198: ...ximum 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...

Page 199: ...he ground side of the tube circuit Post mAs Accuracy 5 or 2 mAs whichever is greater from actual mAs mA Accuracy The actual value will not differ by more than 5 for the indicated value Table A 1 Kv versus mA table kV Large Focus Large Focus Reduced mA Small Focus 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 3...

Page 200: ...t 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 Thickness Tracking AEC compensates for kV between 20 kV and 39 kV and for breast thickness between 2 0 cm and 6 0 cm at appropriate clini...

Page 201: ...f the limits specified in the Exposure Termination section Auto kV Exposure Mode SRL 2000 Bucky Operation When this mode and the Molybdenum filter are selected the system kV will be the default kV selected in the exposure defaults screen The starting kV may be changed to either 25 or 26 kV by the operator When the Rhodium fil ter is selected the kV will default to 28 kV Upon exposure initiation th...

Page 202: ...ed above in Auto kV Upon exposure initiation the AEC signal is sampled to deter mine 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 has been selec...

Page 203: ...Use the following test point tables as an aid for troubleshooting the Affinity Table B 1 Filament Protect Board PN 1 003 0289 Table B 2 Power Control Board PN 1 003 0445 Table B 3 C arm Safety Board PN 1 003 0440 Table B 4 Display Microprocessor Board PN 1 003 0428 Table B 5 Tubehead Control Board PN 1 003 0403 Table B 6 AEC Position Compression Display Microprocessor PN 1 003 0471 Table B 7 AEC P...

Page 204: ... 11 7 V compression up 11 7 V compression down Reference to TP3 TP3 M Motor 11 7 V compression up 11 7 V compression down Reference to TP2 TP5 Vcc 5 V TP6 Sense Active 200 mV TP7 MGND TP8 Vbb 13 6 V TP9 VM 20 V Test Point Voltage Signal Test Point Voltage Signal TP1 Vref TP11 GND TP2 Acc0 TP12 12 V TP3 Acc1 TP13 Vcc TP4 Acc2 TP14 5 V TP5 Not Used TP15 5 V TP6 ACK OK TP16 TPY TP7 DAC 1 TP17 TPX TP8...

Page 205: ...croprocessor PN 1 003 0471 Test Points Test Point Voltage Signal TP1 GND TP2 GND TP3 5 V Rtn TP4 5 V TP5 Vcc TP6 12 V TP7 Host TXD TP8 Host RXD TP9 X Ray Switch 1 TP10 Host Out TP11 Host In TP12 R W Test Point Voltage Signal TP1 VCC TP2 GND TP3 VBB TP4 Mirror Motor 1 TP5 Lamp Motor 1 TP6 Aperture Motor 1 TP7 Filter Motor 1 TP8 Filter TP9 Aperture TP10 Lamp TP11 Mirror Test Point Voltage Signal TP1...

Page 206: ...gulated TP3 15 V StereoLoc II TP4 15 V StereoLoc II TP5 22 V Filament Power TP6 DGND TP7 25 V Tube Control TP8 25 V Tube Control TP9 35 V Bucky Power Unregulated Test Point Voltage Signal TP1 GND Test Point Voltage Signal Function Test Point Voltage Signal Function TP1 kV Control 0 V to 10 V TP27 C Arm Angle Display Slave Select Clock TP2 KV Sense 0 V to 10 V TP28 C Arm Angle Display Serial Clock ...

Page 207: ...10 V TP48 Compression Up 5 V enabled TP23 Tubehead Slave Select Clock TP49 C Arm Down 5 V enabled TP24 Accessory Slave Select Clock TP50 C Arm Up 5 V enabled TP25 AGND TP51 12 V TP26 Read Write Clock Test Point Voltage Signal Test Point Voltage Signal Test Point Voltage Signal TP1 1 V 20 mA IF scaled TP26 Grid Monitor TP51 KVS TP2 Tube Over Voltage TP27 Grid Over Voltage TP52 AGND TP3 VF TOT ADJ T...

Page 208: ...C ADJ TP40 HV Enable TP65 22U TP16 Filament Fault TP41 GND TP66 P 14 V TP17 INV OC ADJ TP42 kV Control TP67 HV COM TP18 HDGND TP43 Brake Relay TP68 15 V TP19 Over Current SET TP44 Brake Time TP69 Filament Return TP20 Rotor IP TP45 Brake TP70 GND TP21 ICOM Sense TP46 HV Fault TP71 LG OC SET TP22 Filament Shut Down TP47 Boost Time TP72 SM OC SET TP23 2 5 V TP48 VP Local TP73 LG GR SET TP24 22U RTN T...

Page 209: ...9 VCC D5 CAL Mode Initiated D10 5 V LED LED ON Indication D1 No power to Board LED LED ON Indication D1 5 V D2 12 V D3 12 V D4 LED Serial CLK Flickers when operating D5 C Angle Flickers when operating D6 MOSI Flickers when operating D7 COMP MISO Flickers when operating D8 COMP SS Flickers when operating D9 TUBE SS Flickers when operating D15 Unit set to Large Focal Spot D16 Unit in Boost mode D17 ...

Page 210: ...ective 3 5 5 0 VDC while L signifies a logic low non reflective 0 5 1 5 VDC Note that the fifth column in Table B 19 provides a graphic representation of the HEX code strip found on each image receptor The light boxes represent a logic high reflective while the dark boxes represent a logic low non reflective The number code given is the code which appears on the Debug Screen for the individual ima...

Page 211: ...1 shows the location of the fuses that are on the Affinity Series Gantry circuit boards One additional fuse is located on the Relay Protection Board part of the Input Power Assembly Chassis Refer to Table B 20 for rating and part number information on the fuses Figure B 1 Fuse Location Gantry ...

Page 212: ... V 1 070 1072 F14 2 AG SLO BLOW 0 50 A 1 070 1242 F1 F4 2 AG SLO BLOW 5 A 1 070 1251 F5 F6 F10 F12 F13 2 AG SLO BLOW 7 A 1 070 1252 F8 8 A Ceramic Body 1 070 1126 F9 3 AG SLO BLOW 7 A 250 V 1 070 1273 F7 CER MDA SB 15 A 1 070 1328 Communications Interface Board 1 003 0434 F2 F15 2 AG SLO BLOW 1 A 1 070 1244 F1 2 AG SLO BLOW 2 A 1 070 1246 HV Generator Assembly 3 000 5074 F1 Power Control Board 1 0...

Page 213: ... Settings Table B 24 HV Control Filament Board PN 1 003 0485 Jumper Settings Table B 21 Microprocessor Board PN 1 003 0493 Jumper Settings Table B 22 Communications Interface Board PN 1 003 0434 Jumper Settings Table B 23 C Arm Safety Board PN 1 003 0440 Jumper Settings Jumper Default Setting Function JP5 Backup Timer Test See Chapter 4 Section 4 4 Backup Timer Test JP6 Backup Timer Test See Chapt...

Page 214: ...is installed for normal operations refer to Chapter 4 Section 9 1 kV Control Offset Calibration p 59 J8 GRID V Not Used leave open Pos 5 4 3 2 1 Pos 5 4 3 2 1 POSITION 5 4 3 2 1 No Jumper Pos 1 to 2 Pos 2 to 3 Pos 3 to 4 Pos 4 to 5 BRAKE TIME 1 5 sec 2 0 sec 2 5 sec 3 0 sec 3 5 sec 4 0 sec 4 0 sec 4 0 sec 4 0 sec 4 0 sec POSITION 5 4 3 2 1 No Jumper Pos 1 to 2 Pos 2 to 3 Pos 3 to 4 Pos 4 to 5 BRAK...

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