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Hologic Affirm MAN-02866, Instructions For Use Manual

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Hologic Affirm MAN-02866 Instructions For Use Manual Download Page 64

Affirm Instructions for Use 

Index 
S 

 
 

 
48 

Part Number MAN-02866 

 

requirements

 

training

 

•

 

xii

 

S

 

select

 

target

 

screen

 

•

 

26

 

Selenia

 

Dimensions

 

biopsy

 

tab

 

•

 

31

 

skills

 

needed

 

•

 

xii

 

specifications

 

•

 

43

 

stereo

 

biopsy

 

mode

 

auto

 

•

 

28

 

C

‐

arm

 

rotation

 

•

 

28

 

manual

 

•

 

28

 

selection

 

•

 

30

 

stereo

 

views

 

•

 

27

 

system

 

description

 

•

 

1

 

host

 

connection

 

verification

 

•

 

15

 

specifications

 

•

 

43

 

verification

 

•

 

15

 

T

 

target

 

guidance

 

screen

 

•

 

20

 

target

 

lesion

 

•

 

34

 

technical

 

support

 

•

 

xiii

 

terms

 

and

 

definitions

 

•

 

xiii

 

training

 

requirements

 

•

 

xii

 

 

Summary of Contents for Affirm MAN-02866

Page 1: ......

Page 2: ......

Page 3: ...Instructions for Use For Software Version 1 6 Part Number MAN 02866 Revision 002 May 2012...

Page 4: ......

Page 5: ...8 0 International Symbols xv 9 0 Warnings Cautions and Notes xv General Information_____________________________________________________________1 1 0 System Description 1 2 0 How to Handle the Biopsy...

Page 6: ...Cleaning______________________________________________________________37 1 0 General Information 37 2 0 Preventive Maintenance Schedule 37 3 0 For General Cleaning 38 3 1 How to Clean the Biopsy Contr...

Page 7: ...me Screen on the Biopsy Control Module 15 Figure 11 Admin Screen 16 Figure 12 Device Field in the Biopsy Tab 16 Figure 13 The Home Screen 19 Figure 14 Target Guidance Screen 21 Figure 15 Green Differe...

Page 8: ......

Page 9: ...uidance Module 3 Table 2 Components of the Biopsy Control Module 4 Table 3 How to Use the Sound Button 23 Table 4 The C Arm Stereo Mode Button 29 Table 5 How to Select the Biopsy Mode 30 Table 6 Radio...

Page 10: ......

Page 11: ...sions accurately in the breast in three dimensions using information extracted from stereotactic pairs of two dimensional images It is intended to provide targeting guidance for interventional procedu...

Page 12: ...peripherals Understands sterile procedures Gives local anesthesia Knows about basic surgical procedures for core biopsy 3 3 Medical Physicist Meets all requirements that apply to the location in whic...

Page 13: ...Module The user control device for the Affirm breast biopsy guidance system Biopsy Guidance Module Holds and operates the biopsy device Responds to commands from the Biopsy Control Module to move the...

Page 14: ...en the fired needle position and the breast platform View The combination of one x ray image and a specified set of conditions for image acquisition X axis The lateral axis from left to right across t...

Page 15: ...missioned material to Hologic or contact your service representative Manufacturer Date of Manufacture 9 0 Warnings Cautions and Notes Descriptions of Warnings Cautions and Notes used in this manual WA...

Page 16: ......

Page 17: ...Biopsy system has two main components Biopsy Guidance Module Biopsy Control Module The Tube Arm on the Selenia Dimensions moves separately from the Compression Arm to allow the acquisition of stereota...

Page 18: ...he Needle Guidance Stage be careful when you move the Biopsy Guidance Module Caution The Affirm Biopsy Guidance Module weighs 15 pounds When you move it be sure to have a secure grip on the handles On...

Page 19: ...n the Selenia Dimensions gantry 2 Handles One on each side Hold both to lift the Biopsy Guidance Module 3 Z axis Control Knobs Rotate either knob to move the biopsy device along the Z axis 4 Z axis Sl...

Page 20: ...igure 5 Biopsy Control Module Table 2 Components of the Biopsy Control Module Name Description 1 Cable Connects to Biopsy Guidance Module 2 Display Screen Shows targets system status name of the biops...

Page 21: ...this manual A combination of components must have the data to validate the safety of the patient personnel and the environment Any additional certification becomes the responsibility of the user WARN...

Page 22: ...Tube Arm movement is motorized Caution To prevent damage or misalignment be careful when you move the Affirm Caution The Affirm Biopsy Guidance Module weighs 15 pounds When you move it be sure to hav...

Page 23: ...he manufacturer is responsible for the effects of safety reliability and performance of this equipment with the following provisions The equipment is used in accordance with Instructions for Use Assem...

Page 24: ......

Page 25: ...ou move it be sure to have a secure grip on the handles Figure 7 Installation of the Biopsy Guidance Module 1 Move the Compression Device down 2 Hold the Biopsy Guidance Module by both handles 3 Slide...

Page 26: ...b item 1 2 Position the Attachment Bracket item 4 until the side with the Lock item 5 is on the front side of the handle 3 Attach the Lock side of the Attachment Bracket around the handle 4 Slide the...

Page 27: ...n 1 Release the Lock Knob item 1 for the Articulating Arm 2 Tilt or change the current angle of the Biopsy Control Module 3 Turn the Lock Knob item 1 to lock the Biopsy Control Module in the new posit...

Page 28: ...der 1 Align the holes top and bottom in the holder with the guide pins on the mount 2 Align the center hole with the mount screw 3 Turn the thumbwheel on the mount to attach the device holder Figure L...

Page 29: ...of the Needle Guide Mount 2 Slide the open area of the U shape in the Needle Guide around the pin in the Needle Guide mount 3 Push the Needle Guide in until the guide locks into position Figure 9 How...

Page 30: ...emove the Biopsy Guidance Module from the Selenia Dimensions 1 Disconnect the Biopsy Guidance Module Cable from the Selenia Dimensions 2 Hold a handle of the Biopsy Guidance Module with one hand while...

Page 31: ...the Biopsy Control Module 1 2 Perform the QAS Needle Test Perform this test one time each day you plan to use the system to confirm the system accuracy Record your results in the QAS Needle Test Check...

Page 32: ...y Mode 1 Select the Admin button on the Selenia Dimensions then select the QAS button from the Admin screen Figure 11 Admin Screen 2 When the QAS screen displays on the Selenia Dimensions Acquisition...

Page 33: ...procedure The targeting of the ball at the needle tip occurs automatically 10 Select the Create Target button to send the target to the Biopsy Control Module Verify that the targeting coordinates are...

Page 34: ...hat the targeting coordinates are within 1mm of X Y and Z numbers on the Current line of the Biopsy Control Module If the targeting coordinates are not within 1mm contact Technical Support Do not try...

Page 35: ...MAN 02866 19 2 0 Biopsy Control Module Screens 2 1 Home Screen The Home screen displays the name or initials of the user who logs in and any error messages The Go button takes the user to the Target G...

Page 36: ...low the user to go to the Previous screen item 3 go to the screen for target selection item 2 go to the screen for motorized movement of the biopsy device in the X and Y axes item 1 select the C Arm M...

Page 37: ...t Information 5 Switch between C Arm Mode or Stereo Mode when system is set for Manual Biopsy Mode 6 This button is gray and disabled 7 Mute or Enable Sound An icon displays on this button and an alar...

Page 38: ...ture of the device Figure 15 Green Differential Cells Yellow and Red Cells Figure 16 Yellow and Red Cells Yellow indicates the biopsy device is in the correct position for that axis but you must move...

Page 39: ...the system repeats a beep sound To stop the sound press the Sound button All system beep sounds are muted and the icon on the button changes When you correct the safety margin violation the icon on th...

Page 40: ...Guidance Screen item 5 and cancel item 7 an audible signal that sounds when there is a problem with a safety margin The display area item 4 of the Jog Mode screen shows the difference between the cur...

Page 41: ...xis Jog value in negative direction 3 Change Y axis Jog value in positive direction 4 Target Information 5 Go to the Previous screen 6 Change X axis Jog value in positive direction 7 Mute or Enable So...

Page 42: ...get coordinates The name of the biopsy device that was selected also displays item 5 To move the biopsy device to one of the targets shown in this screen 1 Press one of the target coordinates icons or...

Page 43: ...iews 3 1 1 How to Add a Stereo View 1 From the Procedure screen select the Add View button Figure 21 Add a Stereo View Figure Legend 1 Trash icon 2 View Modifier 2 Select the STX tab then select the v...

Page 44: ...is applied In Auto Biopsy Mode In the Auto Biopsy Mode the Target Guidance screen does not display the C Arm Stereo Mode button In the Auto Biopsy mode the system automatically allows the C arm to mo...

Page 45: ...ion Select Stereo Mode to acquire stereo images when the system is set for Manual Biopsy Mode Figure 23 C Arm Mode The C arm and Tube Arm rotate together Select C Arm Mode to rotate the C arm and Tube...

Page 46: ...e for Image Acquisition Table 5 How to Select the Biopsy Mode 1 Select the System Status icon Figure 24 System Status Icon 2 Select System Defaults from the System Status menu Figure 25 System Status...

Page 47: ...iopsy tab the Biopsy screen appears This screen displays information about the targets and the biopsy device that is installed on the system The buttons on the left side of this information allow you...

Page 48: ...on If the Biopsy Control Module is unplugged after the targets are transmitted the Biopsy Control Module deletes the targets Resend the targets 2 Reject Target removes the selected target from the lis...

Page 49: ...top of the list and displays with an arrow before the coordinates When multiple targets are created on an image a target set is created All targets in the current target set show with an arrow before...

Page 50: ...et The active target set automatically transfers to the Biopsy Control Module every time a new target is created 5 Repeat this procedure to create multiple targets a maximum of six Note The target tha...

Page 51: ...o Images When you select a stereo pair from the thumbnail area of the Print screen the image mode buttons change See the Selenia Dimensions Instructions for Use for instructions on use of the Print sc...

Page 52: ......

Page 53: ...sinfectant after use x Clean the Breast Platform with a disinfectant after use x Inspect the Biopsy Paddle for damage before use x Inspect the calibration Phantom for damage x Inspect all cables for w...

Page 54: ...ropyl alcohol by volume not diluted 3 maximum concentration of hydrogen peroxide solution After you apply any of the above solutions use a pad and apply a diluted dishwashing liquid to clean any parts...

Page 55: ...mage the equipment decrease imaging performance or increase the risk of electric shock Always follow instructions from the manufacturer of the product you use for cleaning The instructions include the...

Page 56: ......

Page 57: ...isition Workstation Unit is unlatched Put both lock levers into the locked position see the figure Installation of the Biopsy Guidance Module on page 9 Unknown Error 1 Select the system status icon in...

Page 58: ...y Hardware Error 1 Select the system status icon in the taskbar of the Selenia Dimensions 2 Select the Clear All Faults options 3 If the message continues to display contact Technical Support Selftest...

Page 59: ...14 inches 2 0 Biopsy Guidance Module Weight 15 pounds Accuracy 1 mm Range of Movement X axis 35 mm Y axis 72 8 mm Z axis 161 mm Speed of Motorized Movements Continuous No faster than 5 mm per second...

Page 60: ......

Page 61: ...Affirm Instructions for Use Appendix B Forms QAS Needle Test Checklist Part Number MAN 02866 45 Appendix B Forms 1 0 QAS Needle Test Checklist Date Tech X Error Y Error Z Error Pass Fail...

Page 62: ......

Page 63: ...4 biopsy guidance module 14 control module position adjustment 11 control module screens 19 home screen 19 select target screen 26 target guidance screen 20 D definitions and terms xiii G general info...

Page 64: ...y tab 31 skills needed xii specifications 43 stereo biopsy mode auto 28 C arm rotation 28 manual 28 selection 30 stereo views 27 system description 1 host connection verification 15 specifications 43...

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