FMI FIELD MODIFICATION INSTRUCTION FMI No: 12267

FMI Title: Senographe Pristina M3-2/SP1 upgrade

Purpose: Upgrade Pristina Senographe installed base with M3-2 SP1 software

FMI TYPE

☐Recall/Reportable
☒Business – Mandatory/Not -Reportable
☐Business – On Request/Not -Reportable

Section 1: RESOURCES:

Personnel:
1 Field engineer

Time:
2D system: 5 hours
3D system: 6 hours

Section 2: TOOLS, TEST EQUIPMENT, and FIELD SUPPLIED MATERIALS:

- Valid Service Key (5431898-3)

- USB flash memory device with at least 3 Gbytes of free space for backups
- Blank CD for RRA backup (optional depending on site).
- Flat field Phantom (5641619)
- Calibration suitcase (5604511)
- 3 x 40 cm cable tie

Section 3: SPECIAL INSTRUCTIONS:

None

Section 4: TECHNICAL SUPPORT

APAC CHINA EAGM EUROPE

Asia Support Center Asia Support Center GE Healthcare, OLC-E BP 34 GE Healthcare, OLC-E BP34
Phone: 81-426-48-2940 Phone: 81-426-48-2940 F 78533 BUC CEDEX, France F 78533 BUC CEDEX, France
Fax: 81-426-48-2905 Fax: 81-426-48-2905 Tel: +33(0) 1 30 83 13 00 Tel: +33(0) 1 30 83 1300
Or OLC toll free No Or OLC toll free No
Fax: +33 (0) 1 30 70 99 70 Fax: +33 (0) 1 30 70 9970
INDIA LATAM USCAN
India Support Center GE Healthcare OnLine Center GE Healthcare
Phone : 18001027750 / 1 (262) 524 -5300 OnLine Center
18004257255 (800) 321-7937 Milwaukee, 1 (262) 524 -5300
WI 53201 USA (800) 321-7937
Milwaukee, WI 53201 USA

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FMI 12267 FIELD MODIFICATION INSTRUCTION FMI
Section 5: EFFECTIVITY

FMI 12267 is a mandatory FMI for all Pristina IB systems 5582323 (see note below) except the Pristina systems with
Biopsy option.
The Field Action is to upgrade the system Software to “M3-2/SP1” level
FMI 12267 Consignee list: DOC2124548 rev1.
Note: to identify your system, model label is present on the system SIDE LABEL PLATE (for more details, see Pristina
Core Service Manual –Product History and Compatibility - part 2-2 How to Identify Your Model Number and UDI
Labeling)

Section 6: PURPOSE DETAILED

The current FMI aims to upgrade Pristina Software to “M3-2/SP1” version. It will allow to align all Pristina Systems to
latest features level and software corrections.
Depending on initial versions of the system, the upgrade will bring features and fixes as described in Appendix 2.
Pristina Software and Firmware history is listed in Appendix 1.
The main corrections brought by FMI 12267 software upgrade are related to Quality Check and system boot.
Depending on the initial level of Software on site, the customer will get additional changes. Refer to Appendix 2.

Section 7: RELATED FMIs:

None

Section 8: PREREQUISITE

 Download latest Service manual available from SIMS platform:

Senographe Pristina Service Manual class M 5729309-1-8EN Ref [A]

Senographe Pristina 3D Service Manual 5757633-1-8EN Ref [B]

 Before proceeding with FMI instruction, some local information is needed

Does the customer use default passwords or custom one’s?
Does customer use RRA?
 If the system is under Class C Service contract, please note that the Class C Service key associated to the
system will not work anymore after AXIS software installation. A New Class C Service key (part 5797905)
will have to be ordered for this system as per local procedure.

Section 9: KIT ITEM NUMBER & FURNISHED MATERIALS IN FMI KITS:

The FM12267 – Seno Pristina M3-2 SP1 12267 upgrade Kit (PN: 5799566) contains the parts below:

Instruction FMI - Paper

5799395-1EN FMI12267 Seno Pristina M3-2 SP1 upgrade instruction
CDs Software "M3-2/SP1"
5797318 AXIS application software ref [1]
5780855 NG-HELiOS-6.8.1-1.1 Operating System ref [2]
5797313 POS._GENE. Software CD-ROM ref [3]
5797317 RECON application software v02.8.7 ref [4]

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5797416 RECON v02.8.7 Operating System ref [5]
CDs OM (UPCD)
5721683-1-299 Senographe Pristina™ - User Publication CD ref [6]
5764911-299 Senographe Pristina™ 3D User Publication CD ref [7]
5722122-299 SenoBright™ HD - User Publication CD ref [8]
CDs Service (SPCD)
5762781-2EN Senographe Pristina™ - Service Publication CD Class A ref [9]
5721827-1-2EN Senographe Pristina™ 3D Service Publication CD Class A ref [10]
5721867-2EN Senographe Pristina™ Mobile - Service Publication CD Class A ref [11]
5722124-2EN SenoBright™ HD - Service Publication CD Class A ref [12]
Techpub Paper (OM extract) + CNC
5721681-1-199 Senographe Pristina™ - Operator Manual Extract - Publication Folder Multilingual ref [13]
Senographe Pristina™ 3D Operator Manual Extract - Publication Folder
5759050-1-199
Multilingual ref [14]
5721863-199 Senographe Pristina™ Mobile - Operator Manual Publication Folder ref [15]
5721864-199 Senographe Pristina™ Mobile OM Quick Guide - Publication Folder Multilingual ref [16]
M3-2 SP1 Upgrade instruction and MQSA Release Note - Paper
5803739 M3-2 SP1 upgrade instruction ref [17]
Appendix Techpub Paper - specific country
Senographe Pristina™ Senographe Pristina™ 3D - Registration Information - 2D/3D
5792632-199
For Argentina ref [18]
Senographe Pristina™ - Operator Manual Addendum for Russia Publication Folder
5789145-199
Multilingual - For Russia ref [19]
Labels
5780810 UDI label component ref [20]
5780813 Identification label for upgrade kit ref [21]
Product Locator (PLC)
5780785TRA Upgrade kit with M3-2 software ref [22]

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FMI 12267 FIELD MODIFICATION INSTRUCTION FMI
Section 9: PROCEDURE

 Pre-installation (configuration checks, backups)

 Installation
- Axis OS and SW
- For 3D systems only: Recon OS and SW
- Gantry SW and FW (detector, Poseidon, lift, rotation, compression, tilt, BSLM, collimator, Bucky, generator)
- Restore
 Checks and calibrations
 Completion (labelling, customer documentation, report)

Use below instruction table to process to upgrade.

Note: Columns “Comments” and “Done” are NOT for formal reporting and not required to be archived or attached to Service record, but this is to guide the individual performing
the installation on where he/she stands in execution process

Step Section Action Job Card/ Instructions Tools/Supplies Time Comments Done
(min)
1 Pre-installation Check the system IS NOT a Biopsy system 2

Check selected options tick box in Service>Service

Desktop>Configuration>Option management

If the system has the Biopsy option, the FMI shall not be
applied: FMI needs to be cancelled.

Tick the configuration of the system

2D only
3D
3D+2D
3D+2D US
Mobile
SenoBright (CESM)

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Step Section Action Job Card/ Instructions Tools/Supplies Time Comments Done
(min)
2 Pre-installation Brake functional check Refer to core Job Card CHK 15
Calibration suitcase
A001 – Brakes Functional
(5604511)
This check will ensure the brake functionality Torque Test in Core Service
Manual - Ref [A]. 3 cable tie of 40cm
If the test fails go on with the current FMI procedure (no length each
need to consign the system) and plan a corrective job to
apply the required Brake run-in (as described
Completion chapter of Jobcard CHK A001 Completion
chapter). Please note that you will need to get the Brake
replacement kit – 5750487 (loan tool)

In case of failed check not applying the corrective

run-in, may lead to future system failure. The
corrective job planning must be taken as a
priority.

3 Pre-installation Functional check 10

Check system is in working order before performing

upgrade (needed as data will be backed up and restored)

Perform acquisitions using all options: 2D and applicable

options: 3D, CESM, 3D+2D

Query worklist / push to distant hosts

4 Pre-installation Software level check 10

From the Tools menu, select Service>Service Desktop

Compare the SW versions to table in Appendix 1 and
1. Tick the current system software release level:

M3-1

M3-1/UP1

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Step Section Action Job Card/ Instructions Tools/Supplies Time Comments Done
(min)

M3-1/UP1-2

M3-1/UP1-3

M3-1/UP2

M3-2

M3-2/SP1

2. For each SW, Tick column “Needs upgrade” in

Appendix 1:
 with a “X” each time the version is not the
latest
 with a “√” each time the version is the
latest
This column will be useful during procedure to
identify steps to perform.

5 Pre-installation Only for USA, M3-2 SP1 upgrade 2

Report the software release of your system in the MQSA instruction
letter tick box introduction. – ref [17]

Note: MQSA letter is included in M3-2 SP1 Upgrade

instruction delivered with the kit

6 Pre-installation Check that all customer medical images and volumes 15

have been pushed to review work stations and PACS for
archival.

Note: All images will be lost during upgrade.

Note: For France only, the MIRE will need to be installed
again at end of procedure

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Step Section Action Job Card/ Instructions Tools/Supplies Time Comments Done
(min)
7 Pre-installation Passwords record 5

Record previous user passwords and OS passwords

Current system passwords must be recorded before

upgrade. The upgrade will reset all passwords.

Write down passwords for each user listed below:

 Clinical:

 Admin:

 Service:

Write down the passwords for each OS accounts listed

below:

 sdc:

 root:

 insite:

 recon:
8 Pre-Installation Perform a backup SSA Key 5

USB flash memory

Note: The full backup will be done twice to make sure that device with more than
the two backups that are saved on the will be at current Refer to core Job Card ELE A040 1.5Gb free
software level. - Backup and Restore Procedure
from Core Service Manual - Ref
1. Insert the SSA key in Axis Computer USB port [A].
2. From the Tools menu, select:
Service>Service Desktop>Utilities >System >
Backup.

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Step Section Action Job Card/ Instructions Tools/Supplies Time Comments Done
(min)
3. Name the backup file “FMI1” for the first backup
you want to create.
4. Insert your USB flash memory device into the
Console USB port and enable the USB backup check
box.
Click the START button.
5. Once Back-up successfully ends (the button
changes from In Progress to START),

For 3D systems, Check in the results that

reconstruction parameters are taken in backup:
4/10 ReconSetting Backup: SUCCESS
9/10 ReconAlgorithm Backup: SUCCESS

For All systems, Close service desktop and eject

USB flash memory

6. Unplug the USB flash memory device

7. Redo steps 2 to 5 applying backup file name “FMI2”
and without the USB flash memory device
8. With the laptop, verify existence of the backup file
“FMI1date.tar” on USB flash memory device.

Note: Fresh installation of the Axis SW will erase the

backup file present on the disk, but not an install that
“keep the axis data” as recommended below
Note: all systems with a SW release prior to M3-1 UP2 may
have reboot issue when performing the USB backup. In
that case make sure Hard drive backup file exists

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Step Section Action Job Card/ Instructions Tools/Supplies Time Comments Done
(min)
9 Pre-Installation Only for USA, 3D+2D license check 2

Note: 3D+2D (For US) will not exist anymore with Pristina
“M3-2/SP1” release. US sites will have same license as in
rest of the world. Systems configured with 3D+2D (For US)
license, will lose the corresponding license at end of
installation.
If it is a 3D system with license 3D+2D (For US), It will be
necessary to configure manually 3D+2D license after
installation.

Go to License pages:

1. Insert your Service Key into the USB port of the AXIS
2. From Tools menu, select:
Service>Service Desktop > Configuration> Option
Management.
3. Note down if 3D+2D (US) option is checked

3D+2D (US) is checked?

YES

NO

10 Pre-Installation Backup/Restore Limitation 10

For System running Axis software version 1.5 and 2.1.11

(See Appendix 1), the following parameters are not backed
up and need manually backing up.

Note Down or take a picture:

From Tools menu in browser, select

 Service>Service Desktop>Configuration
>System >Auto Negotiation:

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Step Section Action Job Card/ Instructions Tools/Supplies Time Comments Done
(min)
 Service>Service Desktop>Configuration
>System >Net Routing:
 User Preferences>Gantry Preferences>
Motorized compression maximum force:
 User Preferences>Gantry Preferences>
Auto-decompression height:
 User Preferences>Gantry Preferences>
Rotation default oblique angle:
 User Preferences>Gantry Preferences>
Centering light for interventional
duration:
 Service>Service Desktop>Configuration
>General>SITE>Language>Español

Note: Español is the only language not part of the backup.

11 Pre-Installation ePO Antivirus configuration 5

Check if sites has the ePO Antivirus configured you need

to note down the corresponding information.
From Tools menu in browser, select:
Service > Service Desktop > Configuration > SYSTEM >
ePO Config

If no information is filled in, the antivirus is not

activated. Skip this step and next.

Antivirus Activated:
No

YES

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Step Section Action Job Card/ Instructions Tools/Supplies Time Comments Done
(min)
If Yes, note down or take a picture:
 IP Address:

 Port No:

 User Name:

 Password:

12 Pre-Installation In case of need by customer, make an export of the Refer to 2D QC manual, section CD-ROM 10
Repeat and Reject Analysis database to leave on site. Repeat Analysis - Data- base
Use the AWS Export Data- base feature: backup in TEST RAD TECH 09 - OR
Repeat analysis check
USB flash memory
1. Select the Tools icon menu, select IQTool, and device
then RepeatRejectAnalysis button.
2. Insert a blank CD or a USB key
3. Click on either button:
- Export database on CD-ROM
- Export database on USB

13 Installation CPU backup before Axis upgrade Refer to Gantry Booklet 5

Perform a CPU backup before upgrading AXIS Software

that will prevent communication between AXIS and
Positioner.

From tools menu, select

Service>Service Desktop>Utilities>SW/FW
Upgrade>Positioner> Positioner CPU Download>
>click Next
> select Backup
>click Next and Confirm the “Perform Backup”

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Step Section Action Job Card/ Instructions Tools/Supplies Time Comments Done
(min)
14 Installation Install AXIS KEEPING AXIS DATA (All systems) AXIS OS – ref [1] 60
Refer to AXIS Booklet AXIS SW – ref [2]
Note: FOR 3D systems only, the Axis
and Recon installation can be
performed in parallel to gain time.
1. Install AXIS OS keeping AXIS data
Using the AXIS OS CD
Follow Axis Booklet instruction but Ignore the
“fresh install” and select “Install and preserve Axis
Data Partition” instead

 It is important to select “Install and

preserve Axis Data Partition”
If not, some configuration data and all the
backup files will be removed
 Do not keep image partition (very long
process and all images were pushed to
archiver previously)

2. Install AXIS application

Install the Application AXIS DVD

Note: Refer to step 7 of this instruction “Passwords

records” to revert to former passwords.
15 Installation For 3D systems only, Recon OS and SW installation Refer to Recon Booklet RECON OS – ref [4] 20
RECON SW – ref [5]
Note: FOR 3D systems Only, the Axis
and Recon installation can be
performed in parallel to gain time.

Install OS and Reconstruction Software, following

RECON Booklet.

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Step Section Action Job Card/ Instructions Tools/Supplies Time Comments Done
(min)
16 Installation If applicable, Configure AntiVirus Refer to: 30

If, in step 11 of this instruction, the Antivirus Activated

is set to YES, then apply the configuration, else you can 2D SM, Job Card Job Card UPG
skip this step. A001 - AXIS Software Upgrade

Configure the ePO antivirus with the information noted 2D SM, section 6-4 of Job Card
before performing the restore (step 11 of this instruction) PHY A006 - Control Station

 For 3D systems: and Footswitch Cable

Note: It is not possible to upgrade the antivirus Connections
through the reconbox gateway, this is why it is
necessary to connect axis PC directly to ethernet. 2D SM Job Card ELE A018 -
Networking Configuration
- Temporary connect external ethernet to Axis PC:
connect the external hospital recon PC cable to
Axis connection (in below picture: plug cable in 2D SM, Job Card ELE A041 -
[E] to plug [3]) Antivirus Configuration &
Definition Updates

Reconstruction Computer rear panel connectors:

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Step Section Action Job Card/ Instructions Tools/Supplies Time Comments Done
(min)
AXIS Computer rear panel connectors:

- Configure Axis External Network

a. From Tools menu, select:
Service>Service Desktop > Configuration >
SYSTEM > Network IP
b. Click the EDIT button
c. Enter the external IP Address, the Netmask
and IP Address of the hospital gateway for
the system, that was previously configured
for Reconstruction computer (noted in step
11 of this instruction)
d. Click SUBMIT
e. Reboot the system

 For All systems:

- Boot Axis PC
- From Tools menu, select:
o Service>Service Desktop >
Configuration > SYSTEM > ePO Config
- Configure with IP Address, Port Number, User
Name, Password noted in step 11 of this
instruction.
- After Success message displays, close Service
desktop

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Step Section Action Job Card/ Instructions Tools/Supplies Time Comments Done
(min)

 For 3D systems:
- replug the ethernet cables between AXIS
computer and Reconstruction Computer, and
external Network as it was originally
-
17 Installation Restore all AXIS parameters from hard drive backup Refer to core Job Card ELE A040 - SSA Key 10
“FMI1date.tar” Backup and Restore Procedure
from core service manual - Ref USB flash memory with
[A]. backup
1. Insert SSA key in USB port of the AXIS Computer
2. From Tools menu, select:

Service Desktop > Utilities> System Tools>Restore

3. Under the RESTORE SELECTION section, under

Restore Items, select all settings by checking the
boxes

Note: For a 3D system, a second restore will be required

(listed below in the procedure) once the 3D option is
enabled.
4. Select the backup “FMI1date.tar”
5. Click Start
Note: "This backup was not performed on the current
system. Are you sure you want to restore it” might
display, please ignore and go on with the process
6. Check restore is successful: 8/8 items restored:
SUCCESS
7. Reboot the system
Note: If backup is not on hard disk or fails, please
restore from USB key.

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Step Section Action Job Card/ Instructions Tools/Supplies Time Comments Done
(min)
18 Installation For 3D systems, Reestablish connectivity with the 3D Job card ELE A002 – 15
Reconstruction Computer Reconstruction Computer and/or
AXIS Computer Post Install
Configuration section 7.2.1
1. Power on manually the AXIS Computer by pressing
“Reestablish connectivity with
the power button on the front panel of the AXIS
reconstruction computer in 3D
Computer
Service Manual- Ref [B].
2. Power on manually the Reconstruction Computer
by pressing the power button on the front panel of
the Reconstruction Computer

Note: When Axis software is installed, initially there’s no

network connectivity between the AXIS unit and the
reconstruction computer. Therefore, the reconstruction
computer will not automatically power on via the usual
wake-up on LAN signal when the entire system is powered
on. You need to manually power on the reconstruction
Computer by pressing the power button on the front panel.

3. Check the Site system options section of the home

page of the Service Desktop to make sure the 3D
option is activated
4. In tools menu, select:
Service/ Service Desktop / Configuration > 3D
Option > RSA key
Click the Install RSA key button to
create the RSA key on the AXIS
computer
5. Enter the Reconstruction Computer password
M0n!AgneU (0 = Zero) and click OK
6. Confirm the displayed message
7. Check 2D and 3D hostname matches
a. Under the SYSTEM node, click AET parameters.
b. Enter the AXIS hostname in the HostName field
and click SUBMIT.

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Step Section Action Job Card/ Instructions Tools/Supplies Time Comments Done
(min)
Note down the Axis hostname (or take picture)
c. Click the 3D Option node, and click Networking
d. In the Axis Hostname section, in the Axis Name
field enter the exact same parameter that you
have entered as HostName in Step b.

19 Installation Restore the reconstruction Computer Configuration 3D Job Card ELE A002 – 15
Reconstruction Computer and/or
Axis Computer Post Install
1. From Tools menu, select:
Configuration section “Restoring
Utilities > System Tools> Restore the reconstruction Computer
2. Under RESTORE ITEMS select configuration (post LFC)” from
ReconstructionSettings and the 3D Service Manual
ReconstructionAlgorithm
3. Under Media select “FMI1date.tar” from
Internal HDD
4. Click START button
Note: message "This backup was not performed on
the current system. Are you sure you want to
restore it” might display, please ignore and go on
with the process
5. Check restore is successful:
2/2 items restored: SUCCESS
6. Reboot the system
Note: If restore from HDD fails, please use
FMI2date.tar on HDD or, the backup on USB stick

20 Installation User Publications installation Core Job Card ELE A025 - Install Senographe Pristina™ - 15
User Publications in Core Service User Publication CD
manual - Ref [A]. UPCD – ref [6]
1. From Tools menu, select:
Service>Service Desktop > Utilities > If applicable,
eDocumentation > User eDoc. Senographe Pristina™

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Step Section Action Job Card/ Instructions Tools/Supplies Time Comments Done
(min)
2. Insert the User Publication Core CD-ROM: 3D - User Publication
User Publication CD – Senographe PristinaTM CD
UPCD – ref [7]
from FMI kit in the optical drive of the AXIS
Computer.
If applicable,
3. Click the install button.
SenoBrightTM HD (CESM
4. After Success install message is displayed, eject the HD) - User Publication
CD-ROM: CD
a. Select WorkStation Tools node>CD-ROM Eject. UPCD – ref[8]
b. click the EJECT button

If applicable, redo steps 2 to 4 with Options User

publication CD-ROM
User Publication CD – Senographe PristinaTM 3D
User Publication CD – SenoBrightTM HD (CESM HD)

21 Installation For 3D systems only: 3D Job Card IST C002 - License SSA key 5
activation in 3D Service Manual -
Activate 3D+2D option Ref [B].

Note:
 3D+2D mode is now activated for all 3D systems,
it is not an option anymore
 for USA, if it was a 3D system configured with
3D+2D (US) before the upgrade (see step 9 of this
instruction), you need to configure the system with
3D+2D.

1. Insert your Service Key into the USB port of the AXIS
2. From Tools menu, select:
Service>Service Desktop >
Configuration>SITE>Option Management
3. Select the 3D+2D check box (if not yet selected)
4. Submit

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Step Section Action Job Card/ Instructions Tools/Supplies Time Comments Done
(min)
22 Installation Backup/restore manual completion Core Job Card ELE A040 Backup 10
and Restore Procedure section 7
1. Reconfigure parameters recorded in previous step Completion in Core Service
10 of this instruction. Manual- Ref [A].

2. Check the system date and time configuration

(timezone & NTP) within the
Configuration>System>Date-Time Config section of
the service desktop (Job Card ELE A017 – Axis
configuration).
Click on SUBMIT

3. If the 3D option is present, restart the Application

process to sync both the Axis Computer and
Reconstruction Computer.
23 Installation Check Axis installation integrity Core Job Card DIAG C005 - AXIS SSA key 10
Diagnostics in Core Service
1. Insert your Service Key into the USB port of the AXIS Manual- Ref [A].
Computer
2. From the Tools menu, select:
Service>Service Desktop > Diagnostics >
SUBSYSTEMS > AXIS
3. Follow the instructions on the screen: select
Software Integrity checks.
4. Launch the diagnostics.
5. After about two minutes the results are displayed,
check all are “PASS”.

Note: only one “WARNING” is acceptable: “Ping hosts

WARNING.”
And detailed info shows:
systemName is assigned loopback IP 127.0.0.1

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Step Section Action Job Card/ Instructions Tools/Supplies Time Comments Done
(min)
24 Installation Remove all accessories from the gantry (paddles, bucky) 1

Note: This is a preventive action, if one update fails or

freeze, the accessories would be blocked.
25 Installation If XFOV Detector SW is NOT 5.a 20
Or
If XFOV Detector FW is NOT 6.5
(Refer to column “Needs Upgrade” in Appendix 1 to know
if Upgrade is needed)

Update Detector FirmWare

1. From Tools menu select:

Service>Service Desktop > Utilities > SW/FW
Upgrade > Detector
2. Select the Loader Firmware radio button and click
the START button.
3. Once completion message appears, reboot the
entire system
Note: The recommendation on screen is to restart the
console but you need to reboot the entire system.
4. login and the from the Tools menu select:
Service>Service Desktop >Utilities > SW/FW
Upgrade > Detector
5. Select the Application FW radio button and click
the START button.
Note: Detector Application Download may fail at first
trial. Please reboot the system and try again.
6. Once completion message appears, reboot the
entire system

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Step Section Action Job Card/ Instructions Tools/Supplies Time Comments Done
(min)
26 Installation If Poseidon SW is NOT V2.1.11 Gantry and Generator Software POS-Djinn CD -ref [3] 40
Or SW and FW Installation Guide
Booklet
If Poseidon BL is NOT V2.12
(Refer to column “Needs Upgrade” in Appendix 1 to know
if Upgrade is needed)

Update Poseidon

1. Perform Backup CPU Poseidon

 From Tools menu, select:
Service>Service Desktop>Utilities>SW/FW
Upgrade>Positioner> Positioner CPU Download>
>click Next
> select Backup
>click Next and Confirm the “Perform Backup”

2. Flash the CPU board

 From Tools menu, select
Service>Service Desktop>Utilities>SW/FW
Upgrade>Positioner>Positioner CPU Download>
>click Next
> select CPU Flash
>click Next and follow on screen instructions
Reboot Gantry from X-ray Console
 Wait end of gantry reboot before going on

3. Restore the CPU Board

 From Tools menu, select:
Service>Service Desktop>Utilities>SW/FW
Upgrade>Positioner>Positioner CPU Download
>click Next

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Step Section Action Job Card/ Instructions Tools/Supplies Time Comments Done
(min)
>Select Restore
>Click Next and Confirm
Reboot Gantry from X-ray Console
 Wait end of gantry reboot before going on

4. Reactive configuration between AXIS and

Positioner by declaring the MAC on Positioner
Declare MAC on AXIS
 From the Tools menu, select
Service>Service Desktop > Calibration >System
 Click on WOL Axis Pos button.
 Click on Start button.
 When the Calibration SAVED message appears (on
top right panel), click the Ok button.

27 Installation Insert POS-Djinn CD POS-Djinn CD -ref [3] 1
28 Installation If Lift HC12 version is not V9.0.2 Gantry and Generator Software POS-Djinn CD -ref [3] 10
(Refer to column “Needs Upgrade” in Appendix 1 to know SW and FW Installation Guide
if Upgrade is needed) Booklet

Update HC12-MCU
1. From Tools menu, select:
Service>Service Desktop > Utilities > SW/ FW
Upgrade > Positioner > Positioner Node Download
>Next
2. Select Lift MCU and Install
3. Wait until gantry full automatic reboot
4. After reboot, select Continue

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Step Section Action Job Card/ Instructions Tools/Supplies Time Comments Done
(min)
If Lift DSP version is not V7.552.3
(Refer to column “Needs Upgrade” in Appendix 1 to know
if Upgrade is needed)

Update DSP
1. From Tools menu, select:
Service>Service Desktop > Utilities > SW/ FW
Upgrade > Positioner > Next
2. Select Lift DSP and Install
3. Wait until gantry fully reboots

If Lift CPLD version is not V2.5.1

(Refer to column “Needs Upgrade” in Appendix 1 to know
if Upgrade is needed)

Update CPLD
1. From Tools menu, select:
Service>Service Desktop > Utilities > SW/ FW
Upgrade > Positioner > Next
2. Select PatchLift CPLD and Install
3. Wait until gantry fully reboots

29 Installation If Rotation HC12 version is not V9.0.4 Gantry and Generator Software POS-Djinn CD -ref [3] 10
(Refer to column “Needs Upgrade” in Appendix 1 to know SW and FW Installation Guide
if Upgrade is needed) Booklet

Update HC12-MCU
1. From Tools menu, select:
Service>Service Desktop > Utilities > SW/ FW
Upgrade > Positioner > Next
2. Select Rotation MCU and Install

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Step Section Action Job Card/ Instructions Tools/Supplies Time Comments Done
(min)
3. Wait until gantry fully reboots

If Rotation DSP version is not V7.552.5

(Refer to column “Needs Upgrade” in Appendix 1 to know
if Upgrade is needed)

Update DSP
1. From Tools menu, select:
Service>Service Desktop > Utilities > SW/ FW
Upgrade > Positioner > Next
2. Select Rotation DSP and Install
3. Wait until gantry fully reboots

If Rotation CPLD version is not V2.2.2

(Refer to column “Needs Upgrade” in Appendix 1 to know
if Upgrade is needed)

Update CPLD
1. From Tools menu, select:
Service>Service Desktop > Utilities > SW/ FW
Upgrade > Positioner > Next
2. Select PatchRotation CPLD and Install
3. Wait until gantry fully reboots
30 Installation If Compression HC12 version is not V7.392.1 Gantry and Generator Software POS-Djinn CD -ref [3] 10
(Refer to column “Needs Upgrade” in Appendix 1 to know SW and FW Installation Guide
if Upgrade is needed) Booklet

Update HC12-MCU
1. From Tools menu, select:
Service>Service Desktop > Utilities > SW/ FW
Upgrade > Positioner > Next

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Step Section Action Job Card/ Instructions Tools/Supplies Time Comments Done
(min)
2. Select Compression MCU and Install
3. Wait until gantry fully reboots

If Compression CPLD version is not V3.2.4

(Refer to column “Needs Upgrade” in Appendix 1 to know
if Upgrade is needed)

Update CPLD
1. From Tools menu, select:
Service>Service Desktop > Utilities > SW/ FW
Upgrade > Positioner > Next
2. Select PatchCompression CPLD and Install
3. Wait until gantry fully reboots
31 Installation If Tilt HC12 version is not V7.272.0 Gantry and Generator Software 10
POS-Djinn CD -ref [3]
(Refer to column “Needs Upgrade” in Appendix 1 to know SW and FW Installation Guide
if Upgrade is needed) Booklet

Update HC12-MCU
1. From Tools menu, select:
Service>Service Desktop > Utilities > SW/ FW
Upgrade > Positioner > Next
2. Select Tilt MCU and Install
3. Wait until gantry fully reboots

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Step Section Action Job Card/ Instructions Tools/Supplies Time Comments Done
(min)
If Tilt CPLD version is not V2.7.5
(Refer to column “Needs Upgrade” in Appendix 1 to know
if Upgrade is needed)

Update CPLD
1. From Tools menu, select:
Service>Service Desktop > Utilities > SW/ FW
Upgrade > Positioner > Next
2. Select PatchTilt CPLD and Install
3. Wait until gantry fully reboots
32 Installation If IRLOCK HC12 version is not V3.282.10 Gantry and Generator Software POS-Djinn CD -ref [3] 10
(Refer to column “Needs Upgrade” in Appendix 1 to know SW and FW Installation Guide
if Upgrade is needed) Booklet

Update HC12-MCU
1. From Tools menu, select:
Service>Service Desktop > Utilities > SW/ FW
Upgrade > Positioner > Next
2. Select Locking MCU and Install
3. Wait until gantry fully reboots

If IRLOCK CPLD version is not V1.2.10

(Refer to column “Needs Upgrade” in Appendix 1 to know
if Upgrade is needed)

Update CPLD
1. From Tools menu, select:
Service>Service Desktop > Utilities > SW/ FW
Upgrade > Positioner > Next
2. Select PatchLocking CPLD and Install
3. Wait until gantry fully reboots

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Step Section Action Job Card/ Instructions Tools/Supplies Time Comments Done
(min)
33 Installation If Collimator FW version is not V1.19 Gantry and Generator Software POS-Djinn CD -ref [3] 10
(Refer to column “Needs Upgrade” in Appendix 1 to know SW and FW Installation Guide
if Upgrade is needed) Booklet

Update FW
1. From Tools menu, select:
Service>Service Desktop > Utilities > SW/ FW
Upgrade > Positioner > Next
2. Select Collimator FW and Install
3. Wait until gantry fully reboots

34 Installation Install the Bucky then refresh the display by changing 2

service desktop page
35 Installation If Bucky FW version is not ELIXIR V1.4 Gantry and Generator Software POS-Djinn CD -ref [3] 10
(Refer to column “Needs Upgrade” in Appendix 1 to know SW and FW Installation Guide
if Upgrade is needed) Booklet

Update FW
1. From Tools menu, select:
Service>Service Desktop > Utilities > SW/ FW
Upgrade > Positioner > Next
2. Select Bucky Elixir and Install
3. Wait until gantry fully reboot

36 Installation Check the Djinn Generator Versions, Gantry and Generator Software POS-Djinn CD -ref [3] 10
If Application is NOT D7.3.0 SW and FW Installation Guide
or Booklet

If Boot is NOT B7.2.3

or
If Firmware is NOT D7.3.0
Or

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Step Section Action Job Card/ Instructions Tools/Supplies Time Comments Done
(min)
If FPGA is NOT A2.05
Or
If Rotation Firmware is NOT 2.11
Or
if Rotation Boot is NOT 1.04
(Refer to column “Needs Upgrade” in Appendix 1 to know
if Upgrade is needed)

Upgrade Djinn Generator

1. Perform TnT backup
From Tools menu, select:
Service>Service Desktop > Replacement >
Generator > TnT > Backup > Next>Confirm
2. Upgrade Djinn Generator SW and FW
- From Tools menu, select:
Service>Service Desktop>Utilities> Select SW/FW
Upgrade > Generator
- click on the Read Media button.
The generator release available on the CD-ROM is
also displayed in
the onscreen table.
- Check the generator software version and click
on Start installation.
3. Perform TnT Restore
From Tools menu, select:
Service>Service Desktop > Replacement >
Generator > TnT > Restore > Next > Confirm

37 Installation Eject POS-Djinn CD 1

38 Installation Reboot the system 2

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Step Section Action Job Card/ Instructions Tools/Supplies Time Comments Done
(min)
39 Check For 3D systems only, check Axis and Reconstruction PC 2
reboot automatically
40 Calibration and 1. Check the Gain Calibration status Core calibration Job cards: SSA Key 35
checks
Note: If initial SW release is prior to M3-1 UP2, some Job Card CAL A007 - Bad Pixel
calibration files are not restored as not compatible to new Calibration
software. Therefore, they will be marked N/A
Job Card CAL A008 - Detector
Gain Calibration
In tools menu select: Service>Service
Desktop>calibration home page. from Core Service Manual- Ref
Check if Gain grid calibration are “N/A” [A].

2. If Gain grid calibration are “N/A”, you need to

perform the following calibrations and Core Checks Job cards:
corresponding IQ tests. • Job Card ELE A029 - IQ Tools Flat
Note: The new Software introduces a new way to Field Test
calculate grid gain map. This method uses Bad Pixel
• Job Card ELE M031 - IQ Tools
Calibration results and No Grid Gain Map results.
Grid Artifacts Test, section Grid
Therefore, it is necessary to perform Bad Pixel, No Grid
Texture Test
Gain Map and Grid Gain Map. It is not necessary to redo
from Core Service Manual- Ref
Mag Gain Map or 3D Gain Map, even if bad pixel was
[A].
redone

3D jobcard
From Tools menu, select:
CHK A003 - Flat Field test 3D
Service>Service Desktop> Calibration > Detector,
from 3D Service Manual- Ref [B
click Detector and execute the calibrations:
• Bad Pixel
• 2D Gain NoGrid calibrations (Mo/Mo & Rh/Ag)
• 2D Gain Grid calibrations (Mo/Mo & Rh/Ag)

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Step Section Action Job Card/ Instructions Tools/Supplies Time Comments Done
(min)
3. If above calibrations were redone, Perform IQ Tools
test
From Tools menu, select:
Service>Service Desktop > Image Quality
Execute the following IQ tests:
• 2D Flat field no grid (Mo Mo and Rh Ag)
• 2D Flat field grid (Mo Mo and Rh Ag)
• Grid line test.
• Grid texture
• For 3D systems only 3D contact flatfield tests
(Mo Mo and Rh Ag)

Refer to mentioned jobcards in case of failures

41 Calibration Check all calibration status are PASS Scenario CAL A001 - IQ Full 2
If a calibration is FAIL or N/A refer to Scenario CAL A001 - Calibration Process From Scratch
IQ Full Calibration Process to apply needed calibration in Core Service Manual- Ref [A].

42 Check Software versions final check 10

Go to Service>Service desktop > home page and check
the software version displayed exactly matches the “M3-
2/SP1” column of Appendix 1.
43 Check Perform 2D flat field test and if applicable, 3D flat field Core Job Card ELE A029 – IQ tools 5
test. Flat Field Test in Core Service
Manual- Ref [A].

If applicable:
3D Job Card CHK A003 – Flat Field
test in 3D Service Manual - Ref
[B].
44 Check Do Gantry functional checks of all what was impacted by Core Job Card ELE A013 - Gantry 30
the current procedure. Functional Checks in Core Service
Manual- Ref [A].

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Step Section Action Job Card/ Instructions Tools/Supplies Time Comments Done
(min)
45 Check Connectivity test 60
check all connectivity features used by the customer
1. RIS: Request the creation of a test patient on the
RIS and perform a query
2. Perform exams that correspond to site workflow:
3. 2D standard
4. For 3D systems
a. 3D exams
b. 3D+2D exams
5. For CESM systems
a. CESM exams
6. Close the exam and check all the autopush
transfer are done as configured (check the status
in image browser, but also that images are
present on distant system)
7. Do manual push to all configured PACS and
review stations
8. If customer uses it: perform a Query/Retrieve on
PACS
9. If applicable, print images
10. If site uses an iCad system, make sure all needed
images reach iCad and results goes to review
system (specifically If a SenoIris Connect is used
for routing the images)
11. If site uses a Dicom router system (SenoIris
Connect) make sure the images reach the end
destination, not only to the router system.
12. If site uses Generated 2D (v-preview, enhanced v-
preview) router workflow, make sure that the
Generated 2D are processed and dispatched
correctly to the destinations.

Note: With this upgrade, Images acquired with

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Step Section Action Job Card/ Instructions Tools/Supplies Time Comments Done
(min)
3D+2D mode have a different value in the
DICOM attribute “Protocol name” (0018,1030).
If a Dicom Router such as the SenoIris Connect
uses this attribute in the routing rules, the
routing will fail; and images will not reach
destination

46 Check Insite Connection Test SSA Key 30

In Tools menu, check that Virtual Assist is present in the

menu and active (not greyed out)

Note: Even though the ip address is not in the insite

configuration page, the checkout is configured and
functional. Only the display is not updated

Note: if you have changed the passwords, you will need to

give the new passwords to OLC.
Preferably see step 7 of this instruction to revert initial
passwords.
47 Installation For France: Restore MIRE images to the system 5

On system in France, restore the MIRE image on the system

so the physicist will find it for next check

48 Completion Perform a full backup on Hard-Drive Core Job Card ELE A040 - Backup SSA Key USB Key 10
and Restore Procedure in Core
> Name of backup file: “postFMI1”
Service Manual- Ref [A]
Perform a full second backup on USB and Hard-drive
> Name of backup file: “postFMI2”

49 Completion Aide security diagnostic Core Job Card DIAG C006 – SSA Key 10
Security Diagnostics in Core
Note: the following can be done in parallel
Service Manual - Ref [A].
1. Go in: Service Desktop > Diagnostics >
SUBSYSTEMS > SECURITY > AIDE > START

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Step Section Action Job Card/ Instructions Tools/Supplies Time Comments Done
(min)
2. Run "Generate system integrity database on the
AXIS computer"
3. Run “Check system integrity on the AXIS computer”
4. Run “Update integrity database on the AXIS
computer” (it runs 20min in background)
5. Run "Show last run results on the AXIS computer"
50 Completion Fix the identification and UDI labels on the label plate on Core Job Card PHY A015 – Fix UDI Identification label - 2
the left-hand side of the Gantry. labels in Core Service Manual- ref [20]
Ref [A]. UDI label – ref [21]

If the system had a M3-2 version, cover the M3-2 UDI

label with the new one. M3-2 UDI label shall be hidden by
the new M3-2 SP1 label
If the system had an older version than M3-2, fix the label
above the other labels, without covering any existing
label:

51 Completion Only for USA, M3-2 SP1 upgrade 10

Provide MQSA release letter to medical physicist or instruction – ref [17]
customer
52 Completion Dispose of older Software CDs and replace them with AXIS OS – ref [1] 10
Software CDs supplied in the FMI 12267 kit. AXIS SW – ref [2]
Gantry SW – ref [3]
Dispose of the Software CDs supplied in the FMI 12267 kit
not applicable to the site.
If applicable, RECON
OS – ref [4]

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Step Section Action Job Card/ Instructions Tools/Supplies Time Comments Done
(min)
If applicable, RECON
SW – ref [5]
53 Completion Dispose of older user SPCD available on site and replace Core SPCD – ref [9] 10
them with user SPCD supplied in the FMI 12267 kit.
If applicable,
Dispose of the user SPCD supplied in the FMI 12267 kit not
3D SPCD – ref [10] If
applicable to the site.
applicable,
Mobile SPCD – ref [11]
If applicable,
SenoBright SPCD – ref
[12]
54 Completion Provide the customer the applicable user technical Core OM extract – ref 10
publication delivered with the FMI 12276 kit. [13]
If applicable,
3D OM extract – ref
[14]
If applicable,
Mobile OM – ref [15]
If applicable,
Mobile quick guide –
ref [16]
If applicable,
Argentina registration
– ref [18]
If applicable,
Russia OM addendum
– ref [19]
55 Completion 5

If the system is under Class C Service contract,

please note that the Class C Service key
associated to the system will not work anymore
after AXIS software installation. A New Class C
Service key (part 5797905) will have to be
ordered for this system as per local procedure

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Step Section Action Job Card/ Instructions Tools/Supplies Time Comments Done
(min)
56 Completion FE debriefing FMI PLC – ref [22] 5

Update Traceability Database Service (GIB, Siebel…) with

PLC + UDI

57 Completion For security reason dispose of the password previously 2

written-down

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GE Healthcare
Enter required data (For each attempt) into Service System and/or attach documentation into Service System, if feasible or send to local FMI Administrator

Section 10: DISPOSITION OF MATERIALS

1. Dispose of the old materials (CD, DVD, and Technical Publications) according to local requirements.
2. Remove trash, installation equipment and tools. Clean-up room, store service manuals and wash hands after
handling FMI material.
3. Ensure that the system is ready for normal customer operation.
4. Following GEHC’s current processes, package and send unused materials to your pole’s renewable
resources center.
5. If printed on paper format, remove the FMI Instruction from the facility.

Section 11: SERVICE RECORD COMPLETION & DOCUMENTATION REQUIREMENT(S):

Test and Inspection: see procedure instruction Check

FMI Completion Feedback:
For countries equipped with Field MUST or similar on-line systems, use your laptop computer to file your Service
Report. For other countries, fill in the FMI Completion Certification Report and send it to your FMI coordinator.
To avoid time-consuming follow-up, by the field engineer and headquarters, it is very important that FMI Closure
Codes are applied as required on following page which details the Completion Codes and justifications required for
codes.

For sites under MQSA regulation only:

Post-Upgrade Responsibilities of the Facility
As per the quality mammography standard 21CFR 900.12(e) (10) and subsequent guidance developed
by the FDA, any software upgrade is considered to be a Major Repair. As a consequence, a
mammography equipment evaluation (MEE) shall be conducted after this upgrade and before the
customer uses the system for final interpretation of mammograms.
Each facility's medical physicist will be notified that the software upgrade has been installed. This can be
accomplished if the field engineer is able to contact the medical physicist directly or otherwise ensure
that the facility provides this information to the physicist.
MQSA release note (5778275-8EN) from SIMS needs to be printed and given to the customer (Quality
Control

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Enter required data (For each attempt) into Service System and/or attach documentation into Service System, if feasible or send to local FMI Administrator

FMI COMPLETION GUIDE:

Use this table to determine completion status and if additional objective evidence is required.

FMI Completion Definition Debrief (PAT) Best Practice When / When Not to Use this Code
Code Status
Open Initial Code - Work has not yet
0 N/A N/A
been performed.
Implemented fix/modifications per FMI
This code should ONLY be used when
instructions; include testing performed
the service work is completed per
(if required per the FMI Instructions)
The Field Action has been the FMI instructions.
Attach and/or provide test &
completed on given serial
1 Completed inspection document objective
number per instructions. This code should NOT be used to
evidence as required to your Service
describe that the initial
Record *or submit to Service Admin
contact/inspection is complete when
/OP’s team.
the FMI was not executed.

Document details of why field action is This code should ONLY be used when
not required in the Service Record or criteria a-f applies
The Field Action is not required
submit objective evidence to Service This code should NOT be used when
because:
Admin/ OP’s team. the field action cannot be executed
a) Consignee List was Incorrect
due to:
b) Later Version SW
a) Consignee List was Incorrect • Being unable to schedule the
c) FMI previously installed
b) Later Version SW unit (storage, war,
d) Other Hardware changes
2 Not Required c) FMI previously installed postponement) – See Code 3
invalidating FMI
d) Other Hardware changes • Customer refuses the Recall
e) Customer altered equipment
invalidating FMI – See Code 4
f) Equipment was scrapped
e) Customer altered equipment • Cannot Locate the unit -See
destroyed (Do NOT use the term
f) Equipment was scrapped Code 5
retired for scrapped/destroyed
destroyed (Do NOT use the term
equipment)
retired for scrapped/destroyed
equipment)
The Field Action is not executed a, b, c; Document details of why field This code should ONLY be used when
because: action was not executed and what was criteria a-d applies
a) System is in a storage location done with the kit (left with system or This code should NOT be used when:
and field action kit has been returned to warehouse); in the Service • The customer has provided a
placed with device Record or FMI Completion Certificate specific future date to
b) For consignees (distributors), Report (Distributor) and submit execute on the field action –
3 Not Executed confirmed receipt of kit by objective evidence to Service Admin/ this is not a Postponement
consignee OP’s team. • Customer refuses the Field
c) The device is not reachable due Action – See Code 4
to War, Natural Disasters, d; attach postponement letter to • Cannot Locate the unit - See
Embargo, Quarantine, political Service Record or submit to Service Code 5
unrest, and a field action kit has admin. or Service Manager/OP’s team.
been reserved If customer refuses to sign

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GE Healthcare
Enter required data (For each attempt) into Service System and/or attach documentation into Service System, if feasible or send to local FMI Administrator

d) Customer postponement with postponement letter: note that on the

no date when field action can be letter, sign, date and include your SSO.
executed.

Document details of why field action This code should ONLY be used when
was not executed; attach customer criteria a-c applies
signed refusal letter to Service Record This code should NOT be used when:
or send document to your Service • Field action was not required
Consignee/Customer refuses
admin/OP’s team before closure. – See Code 2
delivery or installation of field
If customer refuses to sign, document • Field action was not
action kit and one of the
that attempt in detail on the Refusal executed - See Code 3
following criteria applies:
and/or Location Unknown Form or in • Cannot Locate the unit - See
a) Consignee refuses delivery of
the Service Record. Escalate to Director Code 5
the field action kit.
4 Refused of Service (DOS) or Service Manager.
b) Customer refuses to have field
They will complete second attempt by
action kit installed.
contacting higher authority at site.
c) Consignee/Customer has not
The second attempt should be
responded after 3 attempts
documented by the DOS or Service
(separate days) to contact.
Manager in the Service Record, e-mail
or on the Refusal Form and attach to
the Service Record or send to your
Service admin/ OP’s team before
closure.
Document attempts using the 3 This code should ONLY be used when
Attempts in the “Refusal and/or the device cannot be located.
Location Unknown Form or record the This code should NOT be used when:
required attempt documentation in the • The Field Action is not
Service Record. Documentation” required – See Code 2
included in the FMI instructions. • The Field Action could not
• First attempt must always be a executed due to getting
two-way interaction between access to the system – See
Consignee/Customer or Field GE and the consignee Code 3
Location
5 Engineer cannot find the device. (Distributor or End user). • Customer refusal – See Code
Unknown
• The person contacted by GE 4
must be a credible individual
with accurate knowledge of
medical device locations.
• This may also include physical
searches on site. Note: The
responsibility to track device
locations does ultimately
belong to the consignee.

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Enter required data (For each attempt) into Service System and/or attach documentation into Service System, if feasible or send to local FMI Administrator

• If the unit is not found at this

site but customer states that it
has moved to another site,
document where it has moved
to, close as a code 5 and the
FMI Admin will alert the
appropriate FE.
MOST COMMON CODE 5 SCENARIOS
SCENARIOS: it is not possible cover all
scenarios but below are a few
examples:
Consignee has donated the device to
business “X”. OR
Consignee has sold the device to “X”
OR
Customer says, “I don’t know where it
is” OR “I never had it” OR “It isn’t in
my inventory”
FE closes dispatch as “Location
Unknown” or “Equipment cannot be
Located”, with the first attempt
completed either in the “Service
Record with all required information or
the “Three Attempts Form” and either
attach to the Service Record or send to
your Service Admin/OP’s team before
closure.**
Customer says, “I don’t know where it
is, but I had it” OR “it is in my
inventory but we don’t know where it
is”.
• FE should ask customer to
continue looking for it, Service
Manager/DOS/FE will then call
customer back in 1-2 weeks.
Customer may call FE sooner if
they get any new information.
• If customer still cannot find the
device, FE closes dispatch as
“Location Unknown” or
“Equipment cannot be
Located”, with the first and
second attempt completed on
“Three Attempts Form” and
either attach to the Service
Record or send to your to your
Service Admin/OP’s team
before closure.**

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GE Healthcare
Enter required data (For each attempt) into Service System and/or attach documentation into Service System, if feasible or send to local FMI Administrator

**Remaining attempt(s) will be

completed by Service Admin or
Program Manager

2nd FE should refer to the 1.

A Service Record has been closed out primary FE Service Record for
on a given serial number by any of the FMI completion information.
Customer
Field Modification Service Record following: 2. State reasoning for closing as
Installed
6 has been closed according to 1. 2nd FE administrative or other.
Administrative/
choices in code scenario column. 2. Administrative/Other 3. In detail, state FMI was installed
Other
3. Customer Installed in accordance with FMI
Instructions. (LCS business
ONLY)
NOTE: Reference the Field Actions Recall Development Site: http://supportcentral.ge.com/@Recall

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Doc# DOC2123058 Rev. 3 FMI 12267
 FMI Completion Certification Report
NOTE: Distributors, Dealers or Third Party Service Providers ONLY. FMI #: _____________
Consignee/Customer Name: __________________________________________________________
Street Address: ____________________________________________________________________
City/State/Country: _________________________________________________________________
Country Code: _____________ Phone Number: __________________________________________

Completion Date
System ID Model Number Serial Number Completion Status*
(dd-mmm-yyyy)
☐1-Completed
☐2-Not Required
☐3-Not Executed
☐4 – Refused
☐5 – Location Unknown
☐1-Completed
☐2-Not Required
☐3-Not Executed
☐4 – Refused
☐5 – Location Unknown
☐1-Completed
☐2-Not Required
☐3-Not Executed
☐4 – Refused
☐5 – Location Unknown
☐1-Completed
☐2-Not Required
☐3-Not Executed
☐4 – Refused
☐5 – Location Unknown
*Refer to FMI Completion Guide

Comments:______________________________________________
___________________________________________________________
_____________________________________________
Please provide the signature of the individual submitting this report with responsibility.

Signature: _____________________________________________

Printed Name: __________________________________________

Title: __________________________________________________

Dated and signed this _________day of __________, <year>

Postponement of Medical Device Correction

FMI# _____________________

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FMI FIELD MODIFICATION INSTRUCTION FMI
GE Healthcare
Enter required data (For each attempt) into Service System and/or attach documentation into Service System, if feasible or send to local FMI Administrator

System ID or Device Serial Number and description of Medical Device(s) transferred or sold to
Consignee/Customer:

We, <Consignee/Customer Name>, have elected to postpone the updates required by the Medical Device
Correction referenced above because one of the following conditions exist (Check that which applies).

 Device has been un-installed and a return to service date is unknown at this time
 Device cannot be taken out of service at this time, future availability is not known
 Device has been damaged or modified, such that the updates cannot be made. The schedule for repairs to
the device is not known.
 Device believed to be in Consignee/Customer inventory, but cannot be located at this time

 OTHER:_________________________________________________________________

______________________________________________________________________and the schedule for

repairs to the device or for device availability is not known at this time.

Disposition of associated Medical Device Correction Kit. (Check that which applies).

 Kit(s) have been left with the Consignee/Customer

 Kit(s) have been left with Device
 Kit(s) material will be made available by GEHC at the time of device update

We, < Consignee/Customer Name >, understand the purpose of the correction and associated risk, and will notify
GEHC when the device has been located and is available for updates, or when the updates have been completed.

Dated and signed this _________day of __________, <year>

Please provide the signature of an individual with responsibility for risk and compliance.

Signature: _____________________________________________

Printed Name: __________________________________________

Title: __________________________________________________

NOTE: Translated versions available at http://supportcentral.ge.com/products/sup_products.asp?prod_id=144130

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FMI FIELD MODIFICATION INSTRUCTION FMI
GE Healthcare
Enter required data (For each attempt) into Service System and/or attach documentation into Service System, if feasible or send to local FMI Administrator

Rejection of Medical Device Correction

FMI# _____________________
System ID or Device Serial Number and description of Medical Device(s) transferred or sold to Consignee/Customer:

We, <Consignee/Customer Name>, have elected not to accept the updates required by the Medical
Device Correction referenced above.

Dated and signed this _________day of __________, <year>

Please provide the signature of an individual with responsibility for risk and compliance.

Signature: ________________________________________________________________
Printed Name: _____________________________________________________________
Title: _____________________________________________________________________
Facility Name (i.e. Clinic or Site Name): ________________________________________
Address: __________________________________________________________________
City/State/Country: ________________________________________________________

NOTE: Translated versions available at http://supportcentral.ge.com/products/sup_products.asp?prod_id=144130

Page 43 of 51
Doc# DOC2123058 Rev. 3 FMI 12267
FMI FIELD MODIFICATION INSTRUCTION FMI
GE Healthcare
Enter required data (For each attempt) into Service System and/or attach documentation into Service System, if feasible or send to local FMI Administrator

Refusal and/or Location Unknown Documentation

Check One:

 Refusal  Location Unknown

Attempt 1
Device Name and Serial/ID Number: ______________________________________________________________
Name of the person making the contact (SSO# if applicable): _________________________________________
Date of the Contact (dd/mmm/yyyy): ______________________________________________________________
Contact’s Name: ________________________________________________________________________________
Contact’s Title/Position: __________________________________________________________________________
Contact's Facility Name: _________________________________________________________________________
Response: _______________________ ______________________________________________________________
Contact Method (i.e.; email address, phone) ________________________________________________________

***NOTE: 2nd and 3rd attempts may be more appropriately made by the FMI program team. ***
Attempt 2
Device Name and Serial/ID Number: ______________________________________________________________
Name of the person making the contact (SSO# if applicable): _________________________________________
Date of the Contact (dd/mmm/yyyy): ______________________________________________________________
Contact’s Name: ________________________________________________________________________________
Contact’s Title/Position: __________________________________________________________________________
Contact's Facility Name: _________________________________________________________________________
Response: _______________________ ______________________________________________________________
Contact Method (i.e.; email address, phone) ________________________________________________________
Attempt 3
Device Name and Serial/ID Number: ______________________________________________________________
Name of the person making the contact (SSO# if applicable): _________________________________________
Date of the Contact (dd/mmm/yyyy): ______________________________________________________________
Contact’s Name: ________________________________________________________________________________
Contact’s Title/Position: __________________________________________________________________________
Contact's Facility Name: _________________________________________________________________________
Response: _______________________ ______________________________________________________________
Contact Method (i.e.; email address, phone):________________________________________________________
CONTACT" may include
o The appropriate imaging department, biomedical engineer, and/or asset manager at the last "ship to" address.
o A person with knowledge of medical device locations at the last "billing address.”
o The local Field engineer or Manager that covers "ship to" address o "billing address" area. GEHC employee name
if owned by GEHC.

Page 44 of 51
Doc# DOC2123058 Rev. 3 FMI 12267
FMI FIELD MODIFICATION INSTRUCTION FMI
GE Healthcare
Enter required data (For each attempt) into Service System and/or attach documentation into Service System, if feasible or send to local FMI Administrator

Appendix 1: Software Versions

3. Column “Needs upgrade”: (see step 4): For each SW, Tick column “Needs upgrade” in Appendix 1:
 with a “X” each time the version is not the latest
 with a “√” each time the version is the latest
This column will be useful during procedure to identify steps to perform.

Needs
Upgrade
M3-1 M3-1/UP1 M3-1/UP1.2 M3-1/UP1.3 M3-1/UP2 M3-2 M3-2/SP1
(√/X)
Software Versions
Axis OS NG-HELiOS-6.6.2-1.3 NG-HELiOS-6.6.2-1.3 NG-HELiOS-6.6.2-1.3 NG-HELiOS-6.6.2-1.3 NG-HELiOS-6.6.2-1.3 NG-HELiOS-6.8.1-1.1 NG-HELiOS-6.8.1-1.1
Axis SWPlatform PLATFORM_NGA- PLATFORM_NGA- PLATFORM_NGA- PLATFORM_NGA- PLATFORM_NGA- PLATFORM_NG-2.5-3 PLATFORM_NG-2.6-1
1.20-2 1.20-2 1.20-2 1.20-2 1.20-8
Axis Swacqsvc ACQSVC_NGA-1.20-2 ACQSVC_NGA-1.20-2 ACQSVC_NGA-1.20- ACQSVC_NGA-1.20- ACQSVC_NGA-1.20- ACQSVC_NGB-2.50- ACQSVC_NGB-2.50-17
2B 2B 12 14
Axis SwApps NG_SWAPPS_1.20.4 NG_SWAPPS_1.20.4 NG_SWAPPS_1.20.4 NG_SWAPPS_1.20.4 NG_SWAPPS_1.20.10 NG_SWAPPS_2.2.14 NG_SWAPPS_2.2.21
Axis Axis 1.50 1.50 1.50 1.50 1.50 2.1.11 2.2.55
Recon (3D OS RECON_OS_02.7.0 RECON_OS_02.7.0 RECON_OS_02.7.0 RECON_OS_02.7.0 RECON_OS_02.7.0 RECON_OS_02.8.2 RECON_OS_02.8.7
option)
Recon (3D Application RECON_SW_02.7.0 RECON_SW_02.7.0 RECON_SW_02.7.0 RECON_SW_02.7.0 RECON_SW_02.7.0 RECON_SW_02.8.2 RECON_SW_02.8.7
option)
XFOV Software 4.e 4.e 5.a 5.a 5.a 5.a 5.a
Detector
XFOV Firmware 6.2 6.2 6.5 6.5 6.5 6.5 6.5
Detector
DJINN Application D7.2.10 or D7.3.0 D7.2.10 or D7.3.0 D7.2.10 or D7.3.0 D7.2.10 or D7.3.0 D7.2.10 or D7.3.0 D7.3.0 D7.3.0
Generator
DJINN Boot B7.2.3 B7.2.3 B7.2.3 B7.2.3 B7.2.3 B7.2.3 B7.2.3
Generator
DJINN Firmware D7.2.10 D7.2.10 D7.2.10 D7.2.10 D7.2.10 D7.3.0 D7.3.0
Generator
DJINN FPGA A2.05 A2.05 A2.05 A2.05 A2.05 A2.05 A2.05
Generator
Page 45 of 51
Doc# DOC2123058 Rev. 3 FMI 12267
FMI FIELD MODIFICATION INSTRUCTION FMI
GE Healthcare
Enter required data (For each attempt) into Service System and/or attach documentation into Service System, if feasible or send to local FMI Administrator

Needs
Upgrade
M3-1 M3-1/UP1 M3-1/UP1.2 M3-1/UP1.3 M3-1/UP2 M3-2 M3-2/SP1
(√/X)
Software Versions
DJINN Rotation 2.11 2.11 2.11 2.11 2.11 2.11 2.11
Generator Firmware
DJINN Rotation Boot 1.04 1.04 1.04 1.04 1.04 1.04 1.04
Generator
POSITIONER BUCKY BL EL_BTL SW 0.6 EL_BTL SW 0.6 EL_BTL SW 0.6 EL_BTL SW 0.6 EL_BTL SW 0.6 EL_BTL SW 0.6 EL_BTL SW 0.6
POSITIONER BUCKY FW ELIXIR V1.3 or ELIXIR ELIXIR V1.3 or ELIXIR ELIXIR V1.3 or ELIXIR ELIXIR V1.3 or ELIXIR ELIXIR V1.3 or ELIXIR ELIXIR V1.4 ELIXIR V1.4
V1.4 V1.4 V1.4 V1.4 V1.4
POSITIONER BIOPSY AXE X N.A. N.A. N.A. N.A. N.A. N.A. N.A.
BL
POSITIONER BIOPSY AXE X N.A. N.A. N.A. N.A. N.A. N.A. N.A.
FW
POSITIONER BIOPSY AXE Y N.A. N.A. N.A. N.A. N.A. N.A. N.A.
BL
POSITIONER BIOPSY AXE Y N.A. N.A. N.A. N.A. N.A. N.A. N.A.
FW
POSITIONER BIOPSY AXE Z N.A. N.A. N.A. N.A. N.A. N.A. N.A.
BL
POSITIONER BIOPSY AXE Z N.A. N.A. N.A. N.A. N.A. N.A. N.A.
FW
POSITIONER BIOPSY N.A. N.A. N.A. N.A. N.A. N.A. N.A.
DISPLAY BL
POSITIONER BIOPSY DISPAY N.A. N.A. N.A. N.A. N.A. N.A. N.A.
FW
POSITIONER COLLIMATOR BL01.10 BL01.10 BL01.10 BL01.10 BL01.10 BL01.10 BL01.10
BL
POSITIONER COLLIMATOR V1.19 V1.19 V1.19 V1.19 V1.19 V1.19 V1.19
FW
POSITIONER COMPRESSIO V3.2.4 V3.2.4 V3.2.4 V3.2.4 V3.2.4 V3.2.4 V3.2.4
N CPLD
POSITIONER COMPRESSIO V7.392.1 V7.392.1 V7.392.1 V7.392.1 V7.392.1 V7.392.1 V7.392.1
N HC12
POSITIONER COMPRESSIO V2.0.1 V2.0.1 V2.0.1 V2.0.1 V2.0.1 V2.0.1 V2.0.1
N HC12 PBL
POSITIONER COMPRESSIO V1.4.4 V1.4.4 V1.4.4 V1.4.4 V1.4.4 V1.4.4 V1.4.4
N HC12 SBL
POSITIONER IRLOCK CPLD V1.2.10 V1.2.10 V1.2.10 V1.2.10 V1.2.10 V1.2.10 V1.2.10

Page 46 of 51
Doc# DOC2123058 Rev. 3 FMI 12267
FMI FIELD MODIFICATION INSTRUCTION FMI
GE Healthcare
Enter required data (For each attempt) into Service System and/or attach documentation into Service System, if feasible or send to local FMI Administrator

Needs
Upgrade
M3-1 M3-1/UP1 M3-1/UP1.2 M3-1/UP1.3 M3-1/UP2 M3-2 M3-2/SP1
(√/X)
Software Versions
POSITIONER IRLOCK HC12 V3.282.10 V3.282.10 V3.282.10 V3.282.10 V3.282.10 V3.282.10 V3.282.10
POSITIONER IRLOCK HC12 V2.0.10 V2.0.10 V2.0.10 V2.0.10 V2.0.10 V2.0.10 V2.0.10
PBL
POSITIONER IRLOCK HC12 V1.4.10 V1.4.10 V1.4.10 V1.4.10 V1.4.10 V1.4.10 V1.4.10
SBL
POSITIONER LIFT CPLD V2.5.1 V2.5.1 V2.5.1 V2.5.1 V2.5.1 V2.5.1 V2.5.1
POSITIONER LIFT DSP V7.552.3 V7.552.3 V7.552.3 V7.552.3 V7.552.3 V7.552.3 V7.552.3
POSITIONER LIFT DSP PBL V1.2.3 V1.2.3 V1.2.3 V1.2.3 V1.2.3 V1.2.3 V1.2.3
POSITIONER LIFT HC12 V7.562.2 V7.562.2 V7.562.2 V7.562.2 V7.562.2 V9.0.2 V9.0.2
POSITIONER LIFT HC12 PBL V2.0.2 V2.0.2 V2.0.2 V2.0.2 V2.0.2 V2.0.2 V2.0.2
POSITIONER LIFT HC12 SBL V1.4.1 V1.4.1 V1.4.1 V1.4.1 V1.4.1 V1.4.1 V1.4.1
POSITIONER PDU HC12 V0.172.8 V0.172.8 V0.172.8 V0.172.8 V0.172.8 V0.172.8 V0.172.8
POSITIONER PDU HC12 PBL V2.0.8 V2.0.8 V2.0.8 V2.0.8 V2.0.8 V2.0.8 V2.0.8
POSITIONER POSEIDON BL V2.12 V2.12 V2.12 V2.12 V2.12 V2.12 V2.12
POSITIONER POSEIDON SW V1.1.36 V1.1.38 V1.1.38 V1.1.39 V1.1.39 V2.1.9 V2.1.11
POSITIONER ROTATION V2.2.2 V2.2.2 V2.2.2 V2.2.2 V2.2.2 V2.2.2 V2.2.2
CPLD
POSITIONER ROTATION V7.552.5 V7.552.5 V7.552.5 V7.552.5 V7.552.5 V7.552.5 V7.552.5
DSP
POSITIONER ROTATION V1.2.5 V1.2.5 V1.2.5 V1.2.5 V1.2.5 V1.2.5 V1.2.5
DSP PBL
POSITIONER ROTATION V7.562.4 V7.562.4 V7.562.4 V7.562.4 V7.562.4 V9.0.4 V9.0.4
HC12
POSITIONER ROTATION V2.0.4 V2.0.4 V2.0.4 V2.0.4 V2.0.4 V2.0.4 V2.0.4
HC12 PBL
POSITIONER ROTATION V1.4.2 V1.4.2 V1.4.2 V1.4.2 V1.4.2 V1.4.2 V1.4.2
HC12 SBL
POSITIONER TUBE TILT V2.7.5 V2.7.5 V2.7.5 V2.7.5 V2.7.5 V2.7.5 V2.7.5
CPLD
POSITIONER TUBE TILT V7.272.0 V7.272.0 V7.272.0 V7.272.0 V7.272.0 V7.272.0 V7.272.0
HC12

Page 47 of 51
Doc# DOC2123058 Rev. 3 FMI 12267
FMI FIELD MODIFICATION INSTRUCTION FMI
GE Healthcare
Enter required data (For each attempt) into Service System and/or attach documentation into Service System, if feasible or send to local FMI Administrator

Needs
Upgrade
M3-1 M3-1/UP1 M3-1/UP1.2 M3-1/UP1.3 M3-1/UP2 M3-2 M3-2/SP1
(√/X)
Software Versions
POSITIONER TUBE TILT V2.0.0 V2.0.0 V2.0.0 V2.0.0 V2.0.0 V2.0.0 V2.0.0
HC12 PBL
POSITIONER TUBE TILT V1.4.5 V1.4.5 V1.4.5 V1.4.5 V1.4.5 V1.4.5 V1.4.5
HC12 SBL

Page 48 of 51
Doc# DOC2123058 Rev. 3 FMI 12267
FMI FIELD MODIFICATION INSTRUCTION FMI
GE Healthcare
Enter required data (For each attempt) into Service System and/or attach documentation into Service System, if feasible or send to local FMI Administrator

Appendix 2: Software revision history

If site has M3-2 software, the upgrade will bring:
- IQ/QC corrections:
IQST test: DQE measurement correction
Fix the issue for Bad Scan Lines and bad Data Lines calculation and add Defect Line Density check to prevent
unnecessary detector replacement.
Increase design margin to perform gain map calibration in Mag mode to avoid unwanted QC fail
Lower limit for MTD in Mag mode is corrected to prevent unnecessary detector replacement (limit set from 9% to
6%)
Update method of computation for HFM to limit the impact of low frequency artifacts (include filtering in the
method)

- Workflow corrections:
Correction of the DICOM tag content not filled with good value
Push was CC then MLO but display on RA1000 was MLO then CC
Correction of the search tool in Worklist
Error in image encoding that degrades image in case of print with film composer
PPS not correctly filled in after change view name
RRA summary report is not updated correctly at exam closure
Increase time out from 15 sec to 30 sec to ease association with PACS and avoid push failure
Configuration files are being removed, causing network issue. Correction prevents the file removal

- System reliability & Svc feature, corrections, improvements:

System boot not successful (random behaviour)
Touchscreen console freeze
Gantry LCD freeze
Keyboard / numlock erractic behaviour
Unwanted warning messages / pop-up at boot or restart time
Back-up / Restore not fully functionnal (issue found during upgrade from M3-1 to M3-2)
Error logging to ease system diagnostic

If site has UP2 software, the upgrade will bring:

Page 49 of 51
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FMI FIELD MODIFICATION INSTRUCTION FMI
GE Healthcare
Enter required data (For each attempt) into Service System and/or attach documentation into Service System, if feasible or send to local FMI Administrator

- All Above plus:

- For 3D systems: the ability to perform: 3D+2D exam

If site has UP1.3 software, the upgrade will bring:

- All Above plus:
- Axis boot mechanism failure fixed
- Axis PC freeze fixed
- AIDE integrity failure exceptions added
- Correction to: DICOM tags Swedish characters
- DICOM tag Coding Scheme Designator configurability
- Correction to: SIGMOID tests images
- Correction to: Health Page +IPM Institution name/Hospital Name displayed incorrectly
- Correction to: button not displayed in SUIF>Config>Site>Identification when SSA key plugged
- Correction to: error 511013 Incorrect Option Activation License when replacing Axis PC and restoring a backup
- Correction to: Backup on USB key makes PC rebooting
- Correction to: First shutdown is stuck after a restore of backup
- Correction to: Language and Keyboard not restored correctly in Spanish
- New NVIDIA driver
- Correction to: Shutdown from Service account is making system not functional
- Correction to: VPreview not generated at particular positions.
- Correction to: Auto angulation not reaching exactly 0 degrees after 3D with sliding paddle
- Correction to: QC check algorithm parameters updated during bad pixel and gain calibrations
- Correction to: X-ray taken with collimator lamp ON leading to collimator blades in the image.
- Correction to: Change from Sweep to Synthetic Gain Calibration mechanism.
- Console auto decompression button layout improved
- WW change in IQ tool viewer to reduce false positive artifacts
- Correction to: Reconstruction time synchronization failure
- Improvement on the freeze console due to limitation of the technology
- Correction of Mag Gain Map Calibration fail due to QC Parameter
If site has UP1.2 software, the upgrade will bring
- All Above plus:
- HALT error code 112104 Rotation gas spring failure downgraded as warning

Page 50 of 51
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FMI FIELD MODIFICATION INSTRUCTION FMI
GE Healthcare
Enter required data (For each attempt) into Service System and/or attach documentation into Service System, if feasible or send to local FMI Administrator

If site has M3-1 or UP1 software, the upgrade will bring

- All Above plus:
- Correction of strip image artefact and IFF/AOP failure

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Doc# DOC2123058 Rev. 3 FMI 12267