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Affirm Instructions for Use

Chapter 1

—

General Information

Compliance Information

Part Number MAN-02866

6.0 Compliance

Information

6.1

Requirements

The

manufacturer

responsible

for

the

effects

safety,

reliability,

and

performance

this

equipment,

with

the

following

provisions:

•

The

equipment

used

accordance

with

Instructions

for

Use

•

Assembly

operations,

extensions,

‐

adjustments,

modifications,

repairs

are

performed

authorized

persons

only.

6.2

Label Locations

Figure

Label

Location

Содержание Affirm MAN-02866

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

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Страница 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...

Страница 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...

Страница 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...

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Страница 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...

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Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 24: ......

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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Страница 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...

Страница 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...

Страница 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...

Страница 56: ......

Страница 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...

Страница 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...

Страница 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...

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Страница 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...

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Страница 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...

Страница 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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