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D750b Biopsy Service SM
D750b Biopsy Service SM
GE
Revision History
Date Rev Change Description
December 2017 3 Updated Biopsy option installation when supplied after the system has
been in use. See section 3.2.
November 2016 2 Final update for M3 release
November 2015 1 Initial release
Table of Contents
Chapter 1: Biopsy Option Description ........................................................................... 9
Biopsy Option Overview ......................................................................................... 9
Sub-systems ..........................................................................................................10
Chapter 2: Service Safety ..............................................................................................15
Chapter 3: Biopsy Option Site Preparation and Installation .......................................16
Site Preparation .....................................................................................................16
Installation of the Biopsy Option ............................................................................16
Chapter 4: Planned Maintenance ..................................................................................29
Planned Maintenance Checklist .............................................................................29
Biopsy Unit Inspection ...........................................................................................29
Compression Paddle Inspection ............................................................................30
Biopsy Periodic QC ...............................................................................................30
Biopsy Unit Accuracy QC ......................................................................................30
Gas Spring ............................................................................................................30
Upper Detector Securing Mechanism ....................................................................30
Microswitch Test ....................................................................................................31
Gantry Switches Motion Safety .......................................................................32
Window Size Test ..................................................................................................33
Chapter 5: Calibrations and Service Utilities ...............................................................35
Biopsy Unit Accuracy Calibration .....................................................................35
Microswitch Calibration ..........................................................................................42
Compression Paddle Lockers Calibration ..............................................................48
Compression Paddle Window Contact Calibration .................................................49
Chapter 6: Troubleshooting...........................................................................................52
Instrument panel ....................................................................................................52
Chapter 7: Replaceable Spare Parts List ......................................................................53
Chapter 8: Replacement Procedures ............................................................................54
Biopsy Imaging Unit Covers...................................................................................55
XY Biopsy Imaging Unit Assembly .........................................................................56
Biopsy Module Boards Assembly...........................................................................57
Main Biopsy Cable .................................................................................................66
Biopsy Switch Cable ..............................................................................................72
Compression Paddle .............................................................................................74
Tilt Release Handle ...............................................................................................75
Biopsy Paddle Locker ............................................................................................76
Biopsy Tilt Mechanism Gas Spring ........................................................................78
Biopsy Imaging Unit Module ..................................................................................83
1.2. Sub-systems
The biopsy option includes a dedicated biopsy Imaging unit, a compression paddle, a tilt
mechanism for upper detector, a manual positioner, as well as biopsy SW application.
1.2.1. Biopsy Imaging Unit
The self-contained biopsy unit is mounted above the compression paddle to enable
calculation of the lesion depth (Z).
The unit has two main parts:
Y-arm, containing the CZT detectors (with modules and collimators).
The detectors are aimed towards a common FOV for triangulation.
Positioner at the rear of the biopsy unit, used to for accurate positioning of the Y-arm
above the compression paddle.
Data and power are supplied to the unit via the Main Biopsy cable.
Y-arm
Detector 3
Detector 4
Positioner
Main Biopsy cable
D2 tilted
up
Tilt
mechanism
Mounting
plate
Compression
paddle on
mounting plate
Biopsy unit on
mounting plate
55mm
Verification
rod sleeve
Open the service screw at the bottom of the biopsy Immobilization bracket.
Upper detector
installed
Upper detector
securing screw
b. Add the following lines between the lines </head2> and </default>:
<head3 creationDate=”” numOfPixels=””>
<serialNumbers serial0=””/>
</head3>
<head4 creationDate=”” numOfPixels=””>
<serialNumbers serial0=””/>
</head4>
b. Make sure you are logged in as super-user (type su – and press <Enter>. The
default password is N0t#t00r).
Note:
For a root user, the prompt displays {root@HostName}. To verify you are a root
user – type whoami and make sure the answer is root.
c. Type: mount /dev/cdrom /mnt and press <Enter>.
d. Type: cd /mnt and press <Enter>.
/mnt is added to the prompt.
Select Biopsy Module Replacement from Biopsy Modules Replacement/Swap
Wizard. Click [OK].
From the left menu, select the Biopsy Modules Replacement/Swap screen. The new
module serial numbers are displayed.
In Biopsy Modules Replacement/Swap screen perform the following steps for each
one of the modules:
a. Press [Browse] and select /mnt
b. Select the file with the correct module serial number from the CD and press Open.
c. Press [Upload]
Once the module data is uploaded, a V is displayed.
Click [Back].
Click [Close Biopsy Module Replacement].
3.2.5. Biopsy Unit Assembly and System Tests
Tilt Up the Upper Detector (See D750b Biopsy Clinical Operation Guide for more
information).
From the Biopsy Imaging Unit package, disassemble the soft lower material under
the Biopsy Imaging Unit and place it on the IPS cover.
Mount the Biopsy Unit (See D750b Biopsy Clinical Operation Guide for more
information).
Perform Biopsy Periodic QC (See D750b Biopsy Clinical Operation Guide for more
information).
Mount the Compression Paddle and perform Biopsy Accuracy QC (See D750b
Biopsy Clinical Operation Guide for more information).
The four available needles supported by the system are displayed in both fields: All
Needles and Favorite Needles.
To display only specific needles in the Biopsy scan Needle selection, mark the needles
that are not used in the Favorite Needle list and press the back arrow.
Press [Save].
The needle is now removed from the Favorite Needle list.
If the test fails, perform Biopsy Unit Lock Microswitches Calibration on page 45.
Press the automatic motion button and verify that motion is disabled.
Tilt upper detector up and mount the biopsy unit on the system.
Lock the biopsy unit using only the right lock (biopsy unit right lock handle), leaving
the left lock open.
Press the automatic motion button and verify that motion is disabled.
Lock the biopsy unit using only the left lock (biopsy unit left lock handle), and open the
right lock.
Purpose:
This test ensures that the sterile needle does not contact the non-sterile paddle window.
This test covers for multiple tolerances between a biopsy needle and the paddle aperture,
using the nominal compression paddle that is shipped with the system.
Tools:
Procedure:
Mount the compression paddle and the biopsy unit (See D750b Biopsy Clinical
Operation Guide for more information).
Install the Mammotome needle guiding plate and insert the QC needle through the
central hole.
QC needle in
central hole
Paddle
aperture
NOTE: If the Mammotome needle is not used by your customer, use the relevant needle
used by your customer in this procedure.
Using the X,Y knobs, move along the whole biopsy window range.
Verify that the QC needle does not contact the compression paddle aperture at any
point.
QC needle in
lateral hole
Needle touching
edge of paddle
aperture (Fail)
Using the X,Y knobs, move along the whole biopsy window range.
Verify that the QC needle does not contact the compression paddle aperture at any
point.
If there is contact between the compression paddle and the needle, proceed to
Compression Paddle Window Contact Calibration on page 49
In the Backup screen, select HD Backup, then click [Yes], [Yes] and [OK] in the
following message boxes.
Under Accuracy Calibration, select Phantom Setup and follow the instructions on the
screen:
e. Turn the immobilization knob manually until the phantom anchors (“feet”)
protrude through the paddle aperture. The pressure should be ± 35 N.
Phantom in aperture
Side knob
Upper knob
Knob X and Y
positions
Verify that the X,Y,Z calibration deltas conform with the acceptance criteria.
Microswitch
disconnected
Using a caliber, measure the extent to which the knob screw extends downwards
below the compression paddle bracket.
Open or close the knob until the measurement reaches 0.5mm.
Knob screw
Mount the biopsy unit without the compression paddle. (See D750b Biopsy Clinical
Operation Guide for more information).
b. Open the two small upper screws to disconnect the microswitch bracket.
Microswitch bracket
Tilt handle
knob
washer
c. Stop turning the tilt handle knob when you feel the knob screw touching the
washer.
d. Mark the tilt handle knob and turn clockwise less than half a turn.
Put the microswitch bracket back in place and connect the two upper screws.
Open the other 2 microswitch screws slightly and do the following:
Procedure:
Use a feeler gauge to estimate the gap required to avoid the collision between sterile
and non-sterile parts.
Remove the imaging unit.
Using the feeler gauge, measure the initial calibration gap (Δ1) on the right side of the
compression paddle.
Release the 2x locking wedges by opening the 4 screws on the left side of the
compression paddle.
Add Loctite 242 to the screws and close the screws partially to enable calibrating the
compression paddle position.
Unlock the front and rear clamping wedges on the right side of the compression
paddle.
Move the compression paddle laterally until the gaps on the left side between the
base plate assembly and the compression paddle are as follows:
Left side collision: Initial calibration gap (Δ1) - required gap (Δ2) using feeler
gauge.
Right side collision: Initial calibration gap (Δ1) + required gap (Δ2) using feeler
gauge.
To keep the compression paddle straight during the calibration, insert 2 feeler gauges
of the same thickness between the base plate assembly and the compression paddle.
Firmly hand-tighten the 4 screws on the 2 x static wedges (with the 2 feeler gauges
still in place).
Repeat steps 1 through 5 to verify that there is no contact between the QC needle
and the paddle aperture (needle-to-paddle window boundaries).
Tighten the 4 screws on the 2 x static wedges to a torque of 8Nm.
Run Window Size Test on page 33 to verify that there is no contact between the QC
needle and the compression paddle window.
Chapter 6: Troubleshooting
6.1. Instrument panel
The instrument panel depicts the status of the system at any given time. It displays
information such as motion, power supply, and temperature of the different system
components.
For Instrument Panel usage refer to the Service Manual.
IMPORTANT:
It is recommended not to operate the Instrument Panel while running a scan.
If operating the Instrument Panel is necessary, note that detector temperature data will not
be available.
Do not disconnect the Imaging Unit while the Instrument Panel is running.
5694319 BIOPSY GAS SPRING FOR TILT - SP Biopsy Tilt Mechanism Gas Spring on page 78
5694320 BIOPSY NEW MODULE -PL4 - SP Biopsy Imaging Unit Module on page 83
WARNING!
Any part replacement that may impact the position of the biopsy window in relation to the
biopsy unit must be followed by a QC process to verify that the needle does not contact the
biopsy window.
Participants
Time
1 Field engineer
5 minutes
Procedure:
Dismount the Biopsy Imaging Unit from the system.
Turn the biopsy unit upside down.
Gently remove the Biopsy Imaging Unit cover (3 screws each).
Make sure covers have no scratches or damage. In case of any minor damage,
replace the cover.
Participants
Time
1 Field engineer
30 minutes
Screwdriver
Phillips screwdriver
Allen (Hex) key set
Top of the Imaging Unit
detectors ESD (Electrical Static
2 boards per Imaging Unit: Tools Discharge) mat
Location
BRMB for detector 4 ESD strap
BLMB for detector 3 ESD gloves
Torque Screwdriver
Loctite 222/224
Narrow pliers/tweezers
Disassemble Procedure:
NOTE: During the below procedure use ESD gloves and strap to protect the CZT
modules.
Dismount the Biopsy Imaging Unit from the system.
Turn the Biopsy Imaging Unit upside down and place it on the pre-prepared working
surface.
Remove the left and right Imaging Unit Biopsy Covers (see Biopsy Imaging Unit Covers
on page 55)
Open the 14 screws to remove the aluminum bottom cover of the Biopsy Unit.
Unscrew the relevant (left or right) board (2 screws). Detector 3 connects to BRMB.
Detector 4 connects to BLMB.
Board
screws
BRMB BLMB
Detector 3 Detector 4
Detector 3
Detector 4
IMPORTANT:
In the steps below 3 types of tungsten screws will be C B A
disassembled (See A, B, C). Tungsten is a soft material and
screws are very fragile.
Release 4 x M2.5x10 tungsten screws (A) for each module from the upper part of the
Imaging Unit.
Secure the two screws (HS00410251) with three turns into the tungsten housing pin
location in the Biopsy unit.
Verify that the two pins on each side of the Collimator Extraction Tool are placed
inside the Imaging Unit holes
When securing the screws, make sure both the left and right screws are closed at the
same time, (meaning some turns on the left and some on the right. Continue until the
collimator housing is extracted from the unit.
Service
hole
B
Reassemble Procedure:
Place the board on the position spacers of the two registration pins, on the tungsten
housing cover.
NOTE: Due to necessary accuracy, placing the board on the pin may require force. Be
careful not to damage the board.
Registration pin
with position
spacers
Remove the glue protection sheet from the module thermal pad and place the
thermal pad in the rectangular opening with the glue facing upwards, so that when
the CZT module is inserted, the pad will adhere to the protrusion on the module.
Connect the tungsten housing cover to the CZT module, using a single M3 tungsten
screw with plastic washer in the central hole. Take care not to dislodge the thermal
pad.
Tungsten
housing
cover
CZT module
housing
Tungsten
screws (B)
f. Insert the module housing and board into the XY Imaging Unit
g. Connect the HV and signal connectors to the board.
h. Connect the board in its place (2 screws).
i. Connect the housing to the XY Imaging Unit using 4 screws.
j. Place a new detector label on top of the 4 Tungsten screws. Make sure the label
covers all 4 screws completely.
k. Assemble the Aluminum bottom cover of the Biopsy Unit (8 screws).
l. Assemble the Biopsy Imaging Unit Cover (see Biopsy Imaging Unit Covers on page
55)
To finalize:
a. Connect the Biopsy Imaging Unit to the gantry.
b. Biopsy Daily QC (See D750b Biopsy Clinical Operation Guide for more information)
c. Accuracy QC test (See D750b Biopsy Clinical Operation Guide for more information)
d. Needle to paddle contact test (see Window Size Test on page 33).
e. Disconnect Biopsy Unit and compression paddle and place in Biopsy Unit
packaging.
Participants
Time
1 Field engineer
30 minutes
Procedure:
Dismount the Biopsy Imaging Unit from the system.
Position the Imaging Unit so the Y axis will be on zero.
Board
screws
Dismount 2 cross screws holding the cable and remove both clamps from the cable.
white
plastic
main
cable
bracket
Turn the Imaging Unit upside down and carefully pull the cable out of the imaging
unit.
The new spare cable doesn’t include the white plastic main cable bracket.
Disassemble and reassemble the white plastic main cable bracket as follows:
a. Release the 2 metal nuts.
d. Place the black ring on the white plastic main cable bracket so the white tooth
(see red arrow) is positioned as is depicted in the correct picture below:
e. Attach the black ring with the white bracket to the connector so the white tooth is
face down (in the direction of the cable connector). Close both metal nuts to
secure it.
Reassemble:
Disassemble hood from both new signal connectors.
Thread the cables one by one in the following order:
a. HV cable
b. Detector 3 signal cable (female connector)
c. Detector 4 signal cable (male connector)
Note: push the cables into the Y-shape housing, avoid pulling the cable. When ever
need turn Y-shape.
Close main cable plastic white bracket (4 screws). Check the cable move freely
between hours 1 to 6 like a clock.
Assemble both hoods to connectors. Pay attention to hood orientation.
Connect HV and signal connectors to each of the boards.
Connect boards to their place (2 screws each).
Connect clamps to cable and to the Y-shape.
Insert tie raps to hold cable to it place.
Assemble Aluminum bottom cover of the Biopsy Unit (8 screws).
Assemble both left and right Imaging Unit Bio Cover per procedure (see Biopsy
Imaging Unit Covers on page 55).
To Finalize:
a. Connect the Biopsy Imaging Unit to the gantry.
b. Biopsy Daily QC (See D750b Biopsy Clinical Operation Guide for more information)
c. Accuracy QC test (See D750b Biopsy Clinical Operation Guide for more information)
d. Needle to paddle contact test (see Window Size Test on page 33).
e. Disconnect Biopsy Unit and compression paddle and place in Biopsy Unit
packaging.
Participants
Time
1 Field engineer
30 minutes
Procedure:
Move the detector to 90 degrees position.
Disassemble the tilt covers set. (See D750b Service Manual replacement procedures
for more information).
Use an Allen key to remove the upper aluminum bar (4 screws, 2 on each side)
Upper
aluminum
bar
Screws
Use an Allen key to remove the tilt lower aluminum cover by opening 5 screws on the
bottom.
Use an Allen key to remove the upper detector’s lower base plate cover by removing
11 screws.
Right switch
Left switch
To disconnect the switches, remove 2 screws from each switch (for middle switch,
remove upper screws).
For each cable end, remove the three small switch brackets by opening the screws.
Bracket screw
Bracket
Reassemble:
Assemble the 3 small switch brackets to the new cable.
Note the bracket shapes and cable lengths:
a. Short cable – Parallel (middle) switch
b. Medium cable - Left switch
c. Long cable – Right switch
Connect the cable to the Immobilization board.
Thread the three cables, per cable length, in correct location.
Attach each switch using 2 screws.
Perform the Microswitch test (See Microswitch Test on page 31).
Assemble:
a. Upper detector’s lower base plate cover.
b. Tilt lower aluminum cover.
c. Upper aluminum bar.
d. Tilt covers set.
Participants
Time
1 Field engineer
2 minutes
Location Tools
Top of upper detector cover Allen key set
Procedure:
For systems without the Biopsy unit: Remove the service screw (Preparation on page
16)
Open the detector knob so the detector can be tilted.
Hold the handle and using the Allen key open the locking screw on the top of the
handle.
Participants
Time
1 Field engineer
30 minutes
Location Tools
Right Base plate of Upper Detector None Needed
Procedure
Tilt the Upper detector to tilt position.
Release the lever handle by pushing it out (see green arrow) and turn it
counterclockwise (see red arrow).
Spring
place
Reassemble:
Hold the locker with the springs in place, and screw the lever clockwise.
Assemble the Paddle.
Calibrate the lever handle strength. (See Compression Paddle Lockers Calibration on
page 48).
Participants
Time
1 Field engineer
30 minutes
Procedure:
Position detectors at 0 degrees and power up the system.
Disassemble the Tilt covers set. (See D750b Service manual replacement procedures
for more information).
Remove upper detector cover (See D750b Service manual, replacement procedures).
Use an Allen key to remove the upper aluminum bar (4 screws, 2 on each side)
Upper
aluminum
bar
Screws
Use an Allen key to remove the tilt lower aluminum cover by opening 5 screws on the
bottom.
Use an Allen key to release the timing belt by releasing the safety release handle
assembly screw (see picture)
Use the Allen key to remove the screw and small bracket from the right side of the tilt
mechanism.
Use the Allen key to remove the manual release knob bar by opening 6 screws (3 on
each side).
For left gas spring only: Disconnect the upper detector connectors for HV, ground and
data cable.
Springs to open
Open spring
Reassemble
Bring the detector to parallel position (no need to lock the upper release handle).
Use the Allen key to disassemble the release pin bracket (remove 2 screws).
Hold the detector in tilt position and assemble the gas spring in its place.
Warning
Since the release pin is disassembled the detector should be held in tilt position the entire time
by the field engineer!
Gently move the upper detector to parallel position.
To assemble the release pin bracket, place Loctite 222 on the 2 release pin bracket
screws and tighten to 13 Nm.
Warning
Before final tightening of the screws, move the detector to tilt position (check that the
automatic pin locking occurred).
Move the detector back to parallel position.
Assemble the small bracket and screw (see step 6 in the disassemble procedure).
To assemble the knob bar bracket, put Loctite 222 on the 6 knob bar bracket screws
and tighten to 13 Nm.
Put the timing belt in place and stretch it by closing the bracket screw (see step 5 in
the disassemble procedure).
For left gas spring only, connect upper detector connectors.
Assemble the tilt lower aluminum cover, upper aluminum bar, upper detector cover
and Tilt cover set.
Participants
Time
1 Field engineer
30 minutes
Screwdriver
Phillips screwdriver
Allen (Hex) key set
ESD (Electrical Static
Location In Biopsy Imaging Unit detector 3 Tools Discharge) mat
or detector 4 ESD strap
ESD gloves
Torque Screwdriver
Loctite 222 or Loctite 224
Narrow pliers/tweezers
Procedure Workflow:
Module Identification on page 84
System Backup on page 84
Modules Replacement on page 85
Update the Module Map on page 86
System Diagnostics on page 90
Initial QC, Periodic QC, Accuracy QC and System Backup 2 on page 91
Prerequisite:
Prepare a clean working space next to the system for the replacement procedure.
NOTE:
SWAP modules in the Imaging Unit are available only between Imaging Unit modules.
No SWAP should be performed between MBI detectors and Biopsy Unit modules.
From the left menu, select the Biopsy Modules Replacement/Swap screen. The new
or replaced SWAP module serial number is displayed.
Click [Back].
Click [Close Biopsy Module Replacement].
Wait until all modules reach a stable temperature based on one of the following
options:
The Cold Plate is 0.1 or 0.2°C from its target temperature.
or
No change is observed when [Update] is clicked over a time span of more than 15
minutes.