Image Guided

Therapy
Service information

Field Change Order (FCO)

FCO72200471
Service key compatibility for XP systems

DMR387181 RevB

CSIP Level 2
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Proprietary Notice
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disclosed to others, or disseminated without the prior written permission of the Philips Legal Department. Use of this document and the information contained in it is strictly
reserved for current Philips personnel and Philips customers who have a current and valid license from Philips for use by the customer’s designated in-house service employee on
equipment located at the customer’s designated site. Use of this document by unauthorized persons is strictly prohibited. Report violation of these requirements to the Philips Legal
Department. This document must be returned to Philips when the user is no longer licensed and in any event upon Philips’ first written request.

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Warranty Disclaimer Language
Philips provides this DOCUMENT without warranty of any kind, implied or expressed, including, but not limited to, the implied warranties of merchantability and fitness for a
particular purpose.
Limitations of Liability Language
Philips has taken care to ensure the accuracy of this document. However, Philips assumes no liability for errors or omissions and reserves the right to make changes without further
notice to any products herein to improve reliability, function, or design. Philips may make improvements or changes in the product(s) or program(s) described in this document at
any time.

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Contents

Contents

1 Introduction ....................................................................................................................... 5
1.1 Purpose of this FCO: Symptom, Cause, Remedy....................................................................................... 5

1.2 Document history ........................................................................................................................................ 5

1.3 Glossary ...................................................................................................................................................... 5

2 Safety ................................................................................................................................ 6

3 Planning ............................................................................................................................ 7
3.1 Applies to .................................................................................................................................................... 7

3.2 Opportunities for FCO implementation efficiency........................................................................................ 8

3.3 Supersede information ................................................................................................................................ 8

3.4 Manpower and time to complete ................................................................................................................. 8

3.4.1 Remote deployment ........................................................................................................................... 8

3.4.2 Off-site preparation ............................................................................................................................ 8

3.4.3 On-site deployment ............................................................................................................................ 8

3.5 Application training requirements................................................................................................................ 8

3.6 Tools and test equipment............................................................................................................................ 8

3.7 FCO kit and parts required.......................................................................................................................... 8

3.8 Installed-base registration impact ............................................................................................................... 8

3.9 Field Safety Notice ...................................................................................................................................... 9

4 Workflow .......................................................................................................................... 10
4.1 Off-site preparations.................................................................................................................................. 10

4.1.1 Synchronize offline media pack for latest information. ..................................................................... 10

4.1.2 Download software and burn a CD .................................................................................................. 10

4.1.3 Prepare the tools needed ................................................................................................................. 10

4.2 On-site preparations.................................................................................................................................. 10

4.3 Transport and unpack ............................................................................................................................... 10

4.4 Removal .................................................................................................................................................... 10

4.5 Hardware installation................................................................................................................................. 10

4.6 Software installation .................................................................................................................................. 11

4.6.1 Start the service application in Open Profile .................................................................................... 11

4.6.2 Disable McAfee Embedded Security................................................................................................ 13

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Contents

4.6.3 Install software for smartcard 6121©2016 ....................................................................................... 13

4.6.4 Update McAfee Embedded Security ................................................................................................ 14

4.6.5 Configure smartcard reader access for Omnikey 6121 ©2016/2019 ............................................... 14

4.6.6 Enable McAfee Embedded Security ................................................................................................ 15

4.6.7 Change to Closed Profile ................................................................................................................. 15

4.7 Setting to work .......................................................................................................................................... 15

4.8 Functional test........................................................................................................................................... 15

4.9 Verification test.......................................................................................................................................... 15

4.10 Handover................................................................................................................................................. 15

4.11 Administration ......................................................................................................................................... 15

5 Forms and checklists ...................................................................................................... 17

5.1 Installed-base registration form................................................................................................................. 17

5.1.1 Software release IB registration data ............................................................................................... 17

5.1.2 Inbound IB registration data ............................................................................................................. 17

5.1.3 Outbound IB registration data .......................................................................................................... 17

5.2 FCO Action Notification Report ................................................................................................................. 18

marker

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Introduction Glossary

1 Introduction

1.1 Purpose of this FCO: Symptom, Cause, Remedy

Symptom : Smartcardreader Omnikey 6121 ©2016/2019 is not accepted in WinXP systems.
Cause : Operating system is missing driver for latest Omnikey 6121 ©2016/2019.
Remedy : Install software update with this FCO.

1.2 Document history

Revision Reason for changes
B Link for download software corrected
A First issue

1.3 Glossary
For an explanation of the abbreviations and terms used in this document, refer to the Glossary for
IGT.

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Safety

2 Safety
The system is designed and manufactured according to the international standards for medical
equipment.
Before you start a service action, read the instructions in specific, dedicated, documentation. The
design or the procedures may have changed.

WARNING
• It is only permitted to install released configurations of the system. It is not permitted to replace or
add unreleased items to the configuration during installation or service.
• Be careful when you access, touch, test, adjust, or service the system.
• Obey all warnings and cautions given in specific, dedicated, documentation.
• Read and obey the safety instructions in the document General safety messages.
If you do not obey these instructions, there is a risk of death or serious injury.

NOTICE
• When you touch electronic parts, wear an electrostatic discharge (ESD) wristband.
• Before you replace a spare part, examine the spare part and part package for transport damage.
Do not use a damaged spare part.
If you do not obey these instructions, there is a risk of property damage.

Important
Before you disconnect a cable, make sure that the cable has a label that you can read.

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Planning Applies to

3 Planning

3.1 Applies to
Geography Worldwide
Traceable item identification 459800958881 Allura Xper (OR Table) R 8.1.17 sw pack
(12NC) 459801068881 Allura Xper (OR Table) R8.1.17.1 sw pack
459801087371 Allura Xper (OR Table) R8.1.17.2 sw pack
459801232001 Allura Xper R 8.1.17.3 sw pack
459800975051 Allura Xper (OR Table) R 8.2.17 sw pack
459801172111 Allura Xper R 8.2.17.1 sw pack
459800976481 UNIQ FD (OR Table) R1.0.2 sw pack
459800975081 Allura Centron Release 1.0.2.1 sw pack
Range of serial numbers (if N/A
applicable)
Physical sub, main block(s) and 722010 Allura XPER FD10 System
system code(s) identification 722011 Allura XPER FD10/10 System
where the affected item could be 722012 Allura XPER FD20 System
present 722013 Allura XPER FD20 BIPLANE System
722022 Allura XPER FD10 OR TABLE System
722023 Allura XPER FD20 OR TABLE System
722024 Allura XPER FD10/10 OR TABLE System
722025 Allura XPER FD20 Biplane OR TABLE System
722026 Allura XPER FD10 System
722027 Allura XPER FD10/10 System
722028 Allura XPER FD20 System
722029 Allura Xper FD20/10 System
722033 Allura XPER FD10 OR TABLE System
722034 Allura XPER FD10/10 OR TABLE System
722035 Allura XPER FD20 OR TABLE System
722036 Allura XPER FD20/10 OR TABLE System
722038 Allura XPER FD20/20 System
722039 Allura XPER FD20/20 OR TABLE System
722058 Allura XPER FD20/15 System
722059 Allura XPER FD20/15 OR Table System
722400 Allura Centron
722123 FIELD EXTENSIONS XPER CARDIO SYSTEMS
Field Extension
722124 FIELD EXTENSIONS XPER VASCULAR
SYSTEMS Field Extension
722126 Upgr. R3/R7 to AlluraClarity Cardio Upgrade
722127 Upgr. R2/R3/R7 to AlluraClarity Vascular Upgrade
722128 Upgr. R7.6-R8 to AlluraClarity Upgrade
722133 FIELD EXT. XPER CARDIO SYSTEMS R7.6 Field
Extension
722134 FIELD EXT. XPER VASCULAR SYSTEMS R7.6
Field Extension
Any other type of system N/A
identification number used by the
BG/BU

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Planning Installed-base registration impact

3.2 Opportunities for FCO implementation efficiency

• Distribution method: Download
• Installation method: On-site
• Related FCOs: Not applicable

3.3 Supersede information

Not applicable.

3.4 Manpower and time to complete

3.4.1 Remote deployment

Not applicable.

3.4.2 Off-site preparation

Time Manpower
30 minutes 1 engineer

3.4.3 On-site deployment

Time Manpower
30 minutes 1 engineer

3.5 Application training requirements

Application training required: No

3.6 Tools and test equipment

• TC059 - USB smart card reader (IST service key)
• TC129 - Standard tool kit

3.7 FCO kit and parts required

There is no FCO kit. Before you go to the site, download the software from InCenter.

3.8 Installed-base registration impact

• This action has impact on the installed-base registration.

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Planning Field Safety Notice

• Impacted 12NCs and/or serial numbers are in chapter Installed-base registration form on page 17.

3.9 Field Safety Notice

Not applicable.

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Workflow Hardware installation

4 Workflow

4.1 Off-site preparations

4.1.1 Synchronize offline media pack for latest information.

• Synchronize offline media pack for latest information.

4.1.2 Download software and burn a CD

1. Download the zip file:
http://downloads.incenter.medical.philips.com/doclib/NS/21758406/IGTS_Best/
FCO72200471_4598_018_87071_Smartcard_driver_6121.zip
2. Extract the ZIP file on the service PC.
3. To verify the downloaded files, double-click the md5 file and obey the on screen instructions.
• For more information about verification, refer to the Explanations - How to do Software
Downloads.
4. Burn a CD with the extracted file WindowsXP-KB967048-v2-x86-ENU.exe.
5. Add a label on the CD with 4598 018 87071 FCO72200471 Smartcard drvr 6121 ©2016/2019.
6. Make sure that you can read the CD on the service PC.

4.1.3 Prepare the tools needed

The installation of the software requires besides the latest Omnikey 6121 ©2016/2019 for
configuration, also any of the older service keys: 6020, 6121, 6221 or 3021.
The Omnikey 6121 ©2016/2019 is mandatory for configuration.
IST R3.2 is a work around when older service keys are not available. Prepare the service PC by
installing IST 3.2 if needed.

4.2 On-site preparations

Not applicable.

4.3 Transport and unpack

There are no additional transport and unpack instructions.

4.4 Removal
Not applicable.

4.5 Hardware installation

Not applicable.

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Workflow Software installation

4.6 Software installation

4.6.1 Start the service application in Open Profile

1. Make sure that there is an IST service key in the PC.

Tip
In case none of these keys (Omnikey 6020, 6121, 6221 or 3021) are available, use the service PC
to push your IST entitlement to the system.

2. Do the service procedure System > Installation > Installation, to start the system in Open profile.

4.6.1.1 Use IST Push

If IST is on your service PC, you can 'push' the IST entitlements to another PC (for example, host PC
of the X-ray system). When the host PC receives the IST entitlements, it is not necessary to install a
smart card reader before you start the service application on the host PC.
The IST push functionality does not (always) work with latest IST software (IST 3.3.0).

Configure the service PC

1. Disconnect the hospital network from the system.
2. Use a network cable to connect the service PC to
the control room network switch.
3. Configure the service PC on the control room
network:
• On the service PC select Settings >
Network & Internet > Ethernet > Change
adapter options.
• Double-click the network connection.
• Select Internet Protocol Version 4 (TCP/
IPv4).
• Click Properties. Fig. 1: IST control panel
• Select Use the following IP address.
• Check the IP address of the host PC. Refer to
the SRM.
• Enter an unused P address that is in the range
of the control room network.
• Enter the subnet mask: 255.255.255.0 .
4. Test the connection:
• Start CMD.
• Type Ping <IP address of host PC> .

Configure IST Push

1. Open the IST Control Panel.
2. Select Tools > Remote Entitlement Mgr.

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Workflow Software installation

3. On the service PC, open IST Control Panel.

4. Go to Tools > Remote Entitlements Mgr.
5. Select IP address <IP address of host PC>.
• The certificate transfers to the system.

Fig. 2: Philips IST Remote Entitlements Manager

Restore the settings

1. Disconnect the network cable from the service PC to the control room network switch.
2. Connect the hospital network to the system.
3. Configure the service PC to the original settings:
• On the service PC select Settings > Network & Internet > Ethernet > Change adapter
options.
• Double-click the network connection.
• Select Internet Protocol Version 4 (TCP/IPv4).
• Click Properties.
• Select Obtain an IP address automatically as this was most likely the original setting.
• Click OK.
• Close the open windows.

4.6.1.2 Downgrade to IST R3.2

IST push functionality is not part of IST version 3.3 but is available with IST version 3.2.
Downgrade the IST software to version 3.2:

NOTICE
Do not uninstall IST version 3.3.
If you do not obey these instructions, there is a risk of property damage.

1. Download IST software version 3.2 from this link:

http://downloads.incenter.medical.philips.com/doclib/NS/21282882/IGTS_Best/IST/
IST_x64_3.2.4.20180228.zip
2. Unzip the downloaded file on the service PC.
3. Double click IST_x64_3.2.4.20180228.exe.

4. In the “Setup” pop-up, click Yes.

Fig. 3: Pop-up window

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Workflow Software installation

5. In the “Uninstalling IST” pop-up, click Yes

Fig. 4: Pop-up window Uninstalling IST

6. Make sure your IST registration is still valid, after the restart.

4.6.2 Disable McAfee Embedded Security

NOTICE
With McAfee Embedded Security (Whitelisting) disabled, the X-ray system is vulnerable to malware.
If you do not obey these instructions, there is a risk of property damage.

1. Remove all USB flash drives from the host PC.

2. On the Windows desktop, double-click Disable McAfee Embedded Security.
3. Press the Ctrl+Esc keys.
4. On the Start menu:
• For WinXP: click Shutdown, then click Restart.
• For Win7: click Restart.

4.6.3 Install software for smartcard 6121©2016

1. Put the CD 4598 018 87071 FCO72200471 Smartcard driver 6121 in the DVD drive.
2. Press Windows key + E to start file explorer.
3. Browse to the DVD drive and select the file WindowsXP-KB967048-v2-x86-ENU.exe
4. Double-click WindowsXP-KB967048-v2-x86-ENU.exe
5. Click Next >.
6. Select I Agree and click Next >.
7. Click Finish.
8. Remove the CD from the DVD drive.
9. Close the file explorer window.

Check installation (optional)

1. Press the Ctrl+Esc keys.
2. On the Start menu, click Control panel.
3. Double-click Add or Remove Programs.
4. Click the checkbox Show updates.
5. Scroll down the list to check that the software installation is successful.

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Workflow Software installation

Fig. 5: Add or Remove programs

6. Close the Add or Remove Programs window.

7. Close the Control panel window.

4.6.4 Update McAfee Embedded Security

• On the Windows desktop, double-click the shortcut Update McAfee Embedded Security.

4.6.5 Configure smartcard reader access for Omnikey 6121 ©2016/2019

1. Put the smartcard reader Omnikey 6121 in
the host PC.
2. Press the Ctrl+Esc keys.
3. On the Start menu, click Control panel.
4. In the Control panel, click Safeguard
smartcard provider properties.
5. When letters A, B and C are all used,
select the Omnikey CardMan 6020 and
click Delete
6. Select the HID Global OMNIKEY 6121.
7. Press Assign.
8. Select A, B or C.
- Make sure the letter is available.
9. Close Safeguard smartcard provider
properties. Fig. 6: Safeguard HID Global OMNIKEY 6121
10. Close the Control panel window. configured

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Workflow Administration

Important
After configuration the system is only accessible with the configured smartcard readers.

4.6.6 Enable McAfee Embedded Security

1. On the Windows desktop, double-click the shortcut Enable McAfee Embedded Security.
2. On the Start menu of the Windows desktop, select Shut down.
3. Turn off the X-ray system with the Off button on the review module.
4. Wait for approx. 7 minutes for the system to power down completely.
5. Turn on the X-ray system with the On button on the review module.

4.6.7 Change to Closed Profile

• On the Windows desktop, double-click Shutdown to Start System.
• The system starts in Closed Profile.

4.7 Setting to work

Not applicable.

4.8 Functional test

Not applicable.

4.9 Verification test

Not applicable.

4.10 Handover
1. Record your action in the system logbook (paper or electronic).
2. Collect all tools and materials.
3. Install all (cabinet) covers.
4. Clean the room.
5. Tell the customer about the service action and results.

4.11 Administration
1. If required, fill out the attached FCO Action Notification Report (ANR) and send it to your regional
Customer Services manager.
• The ANR is for region use only. Do not return it to the BU.
• If there are more than 5 devices at the customer site, attach a list of all devices to the ANR. Add
the Product Number, Serial Number, SWO Number and UDI number (if applicable) to the list, then
mark all entries in the ANR as “Not applicable – See attached list”
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Workflow Administration

2. Return, recycle, or discard parts and materials:

• Return unused FCO kits as soon as possible, according to the standard return process.
• Return repairable and returnable spare parts and tools. Complete the supplied return form.
• Recycle or discard other defective and superfluous parts and materials according to local
regulations.
• If the removed part contains patient data, use the Authorization of Media Disposition Form.
3. Record the results and measured values.
4. Update the installed-base registration, if necessary.
5. Close the service work order (SWO).

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Forms and checklists Installed-base registration form

5 Forms and checklists

5.1 Installed-base registration form

This service action has impact on the installed-base registration.
Site
System type
System ID
Local ID
Make sure that your local installed-base registration of this system is updated with the 12NCs and/or
serial numbers that follow.

5.1.1 Software release IB registration data

• Software release: 4598 018 87071 FCO72200471 Smartcard driver 6121

5.1.2 Inbound IB registration data

Add these parts to the installed-base registration data:
12NC Description Serialized? Serial number
4598 018 87071 FCO72200471 Smartcard driver 6121 No -

5.1.3 Outbound IB registration data

Remove these parts from the installed base registration data:
12NC Description Serialized? Serial number
- - - -

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Forms and checklists FCO Action Notification Report

5.2 FCO Action Notification Report

FCO title: Service key
FCO category: Service Recommendation FCO number: FCO72200471
Product Enhancement
Applies to: 459800958881 Allura Xper (OR Table) R 8.1.17 sw pack
459801068881 Allura Xper (OR Table) R8.1.17.1 sw pack
459801087371 Allura Xper (OR Table) R8.1.17.2 sw pack
459801232001 Allura Xper R 8.1.17.3 sw pack
459800975051 Allura Xper (OR Table) R 8.2.17 sw pack
459801172111 Allura Xper R 8.2.17.1 sw pack
459800976481 UNIQ FD (OR Table) R1.0.2 sw pack
459800975081 Allura Centron Release 1.0.2.1 sw pack

Hospital . Location .
address: / site ID:

Product . Product . SWO .

number: SN: number:
UDI: .
Product . Product . SWO .
number: SN: number:
UDI: .
Product . Product . SWO .
number: SN: number:
UDI: .
Product . Product . SWO .
number: SN: number:
UDI: .

Action on this/these unit(s) was: (select one)

[ ] Completed by Philips or Approved Service Provider as per instructions but Date: .
Philips Enterprise Resource Planning system is unavailable. [dd-mmm-yyyy]

[ ] Completed by Customer for customer installable Field Change Order, as Date: .

per instructions. [dd-mmm-yyyy]

[ ] Where applicable, applications training provided by Philips or Approved Date: .

Service Provider upon implementation of a Change Order. [dd-mmm-yyyy]

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Forms and checklists FCO Action Notification Report

Or not completed on this/these unit(s) because: (select one)

[ ] This unit is not affected per Field Change Order implementation instructions (state reason in additional
information below).
[ ] The location of the device is unknown or currently in storage. The Customer has been informed that If the
location of the device is identified or has been put into clinical use from storage, they are to contact their local
Philips Service Organization.
[ ] The customer refuses to install Field Change Order (state reason and the name and title of the person
refusing in additional information below).
[ ] The device is permanently out of service. (i.e. The device is in a condition where it cannot be returned to
service unless it is returned to the original manufacturer for repair / refurbishment to its published
specifications).

Additional information as to why the Field Change Order was not completed, or if customer signature is not required /
customer refuses to sign:
.

CUSTOMER ACKNOWLEDGEMENT: I certify that I am authorized to sign this Action Notification Form on
behalf of my organization. By signing below I am acknowledging that the REASON and PURPOSE for this
modification that it has been explained to me and it was completed based on information that I provided to Philips.
If customer signature is not required, please state the rationale above.
Customer . Title: .
name:
(Print)

Customer . Date: .
[dd-mmm-yyyy]
signature:

PHILIPS/APPROVED SERVICE PROVIDER ACKNOWLEDGEMENT:

Name: . Title: .
(Print)

Signature: . Date: .
[dd-mmm-yyyy]

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© 2021 Koninklijke Philips N.V. www.philips.com/healthcare

All rights are reserved. Reproduction or transmission in whole or in part, in

any form or by any means, electronic, mechanical or otherwise, is DMR387181 RevB * April 2021
prohibited without the prior written consent of the copyright owner. CSIP Level 2