Philips Healthcare

FIELD CHANGE ORDER Service

Issued by : ECR, Nicole Mackenzie FCO Ref No. : FCO86100172A
Supersedes : None Date : 15-July-2015

FCO86100172A 861290 HeartStart XL+ Defibrillator Multiple Software and Hardware

TITLE :
Issues

CLASSIFICATION:
_X_ Mandatory Action
____ Action for Performance – Proactive
____ Action for Performance – Retrofit on Failure
____ Service Recommendation

APPLIES TO:

Geography : Worldwide

Traceable Item Identification PMS Number: Part Number:

861290 861290

Range of Serial Numbers See UAL86100172

Commercial (Sales) Product Number PMS Number: Part Number:
861290 861290

LIST OF PAGES & DRAWINGS:

Body of FCO Pages 1-9
Sample of Field Safety Notice FSN86100172FCO Action Pages 10-14
Notification Report (ANR Form) Page 15

INTRODUCTION:
This FCO covers the resolution of multiple Software and Hardware Issues noted with the XL+
Defibrillator/Monitor. Through internal testing and customer complaint investigations software and hardware
issues were identified. This FCO consists of a software upgrade and hardware components that are to be
replaced.

(Template Document Number: A-Q2920-00108-T1, Rev. N)

Field Change Order Document Number FCO86100172A Rev. A Page 1of 15
Symptom : This FCO covers multiple issues exhibited on HeartStart XL+ devices.

1) The XL+ has several issues that are related to issues in the previous software version
(B.00.xx).
a) The XL+ may fail to complete the power on sequence and continuously reboot.
b) The XL+ may either fail to power up or may shut down unexpectedly.
c) The XL+ may fall into a condition were a fail-safe monitoring component is not
reset.
d) The XL+ may fail to generate verbal prompts in AED mode.
2) The XL+ speaker may fail.
3) The XL+ can shut down unexpectedly or remain powered on and not acknowledge or
charge the battery.
4) The XL+ exceeds the allowable radiated emissions level for Class B CISPR11.
5) Loss or unrecoverable ECG signal.
6) Loss of SpO2 signal and loss of SpO2 communication that can cause a device reboot.
7) Disruption of battery detection system causing a false low battery alarm.

Cause : 1) The XL+ has several issues that are related to the previous software version (B.00.xx)
a) The XL+ may fail to complete the power sequence causing continuous reboots to
occur.
b) A software error can occur causing the XL+ to fail to power up or shut down
unexpectedly.
c) Software upgrades B.00.02 or earlier can interfere with the reset of a fail-safe
monitoring component.
d) A software error can cause the XL+ to lose voice prompts.
2) The XL+ speaker housing can short to ground.
3) The battery may not seat properly on the internal battery connector.
4) When the XL+ is connected to AC power and exposed to Electrical Fast Transients
(EFT) the insufficient shielding can allow excessive radiation emissions.
5) The ECG signal may be lost or unrecoverable when exposed to EFT.
6) The SpO2 communication may fail when connected to AC power and exposed to EFT
causing the device to reboot.
7) The battery detection system can be disrupted when connected to AC power and
exposed to EFT causing a false latching low battery alarm condition.

Remedy : 1) Upgrading software to version B.01.00 will correct the software issues.
2) Replacing the Speaker Assembly II will correct the speaker failure issue.
3) Replacing the Battery PCA Connection II with Stabilizer will correct the issue of the
battery not seating properly.
4) Several cables and parts have been modified to in an effort to reduce radiation
emissions. Replacing of the following parts will correct the radiation issues.
 Therapy PCA Exchange II
 Processor PCA Exchange II
 Rear I/O Assembly II
 Therapy Port Receptacle II with Therapy Receptacle extender
 LAN to Processor II Cable
 Power Supply to Therapy PCA Cable II
 Replace ECG Port Connector Block II
5) Replacement of Therapy Port Receptacle II, Therapy PCA II and installation of Therapy
Receptacle extender will correct the ECG signal loss issue.
6) Replacing the Rear I/O Assembly II and upgrading to software version B.01.00 will
correct the SpO2 communication failure issue.
7) Replacing the Rear I/O Assembly II, Processor PCA II and upgrading to software
version B.01.00 will correct the false low battery alarm issue.

MANPOWER / TIME TO COMPLETE:

Implementation:
3.5 Hours
1 Engineer

(Template Document Number: A-Q2920-00108-T1, Rev. N)

Field Change Order Document Number FCO86100172A Rev. A Page 2of 15
Implementer: Please check appropriate box or boxes:
 Philips Engineer or Approved Service Provider
Customer
 No Engineer Required
TOOLS & TEST EQUIPMENT:
 Torx T10, T15, and T-20 drivers (or Torx driver kit). T15 driver shaft should be less than 0.4-
inches (10 mm) in diameter to reach down to recessed handle screws.

TIP: You need the T-20 driver only for the Paddle Tray and Plates replacement.

 Slip-joint pliers or adjustable open-end wrench.

 Therapy Port Nut Socket Kit (453564556231) or open-jaw 1 1/8" (29-mm) or adjustable
wrench for Therapy Port replacement.
 Straight-tip needle-nose pliers or tweezers.
 Bent-tip needle-nose pliers whose jaws are covered with a soft material (e.g. plastic tubing
or tape).
 Utility knife.
 Wire cutter.
 Four pins of no more than 1/8" (3 mm) in diameter to support the Rear Chassis in removal
and replacement procedures. T15 and smaller screwdrivers may be used.
 Software Support tool for upgrades and Processor PCA repairs.
 Defibrillator Discharge Tool (M2475-69573).
 Gloves and ESD protection for PCA handling.
 The test equipment required to run performance verification and safety tests listed in the
“Verification Test Equipment” table in the “Performance Verification” chapter of the
HeartStart XL+ Service Manual (989803160581, Edition3).

(Template Document Number: A-Q2920-00108-T1, Rev. N)

Field Change Order Document Number FCO86100172A Rev. A Page 3of 15
MODIFICATION KIT / PARTS REQUIRED:

Modification kit: Hardware:

453564580931 XL+ FCO86100172 SPK
453564570771 XL+ PCA Therapy Exchange II SPK, Key Component
453564570781 XL+ PCA Processor Exchange II SPK, Key Component
453564570691 XL+ CONN Block ECG, EtCo2 II (if option present)
453564570701 XL+ CONN Block ECG, SpO2, EtCo2 II (if option present)
453564570711 XL+ CONN Block ECG, SpO2, NBP, EtCo2 II (if option present)
Software:
HeartStart XL+ Software Support Tool Kit Revision B.01.00 (USB memory stick,
language specific, use the chart below)

American English 453564205861

Commonwealth English 453564205871

Chinese - Simplified 453564205881

Chinese - Traditional 453564205891

Danish 453564205901

Dutch 453564205911

Finnish 453564205921

French 453564205931

German 453564205941

Greek 453564205951

Italian 453564205961

Japanese 453564205971

Korean 453564266321

Norwegian 453564205981

Polish 453564418301

Portuguese 453564205991

Portuguese – Brazilian 453564206001

Spanish 453564206021

Swedish 453564206031

(Template Document Number: A-Q2920-00108-T1, Rev. N)

Field Change Order Document Number FCO86100172A Rev. A Page 4of 15
Containing: XL+ FCO86100172 SPK (453564580931) contains the following parts:

1) XL+ Rear I/O Assembly II

2) XL+ LAN to Processor II Cable
3) XL+ Power Supply to Therapy PCA II Cable
4) XL+ Speaker Assembly II, Key Component
5) XL+ ECG Port Connector Block II
6) XL+ Therapy Receptacle II, Key Component
7) XL+ Therapy Receptacle extender, Key Component
8) XL+ PCA Battery Connector PCA with Battery Board Stiffener
9) 1- Battery Data Cable (if damaged or lost during removal)
10) 4- M3 x 8 screws (if damaged or lost during removal)
11) 2- M4 x 12 screws (if damaged or lost during removal)
12) 2- Saddle Wire Clamps (if damaged or lost during removal)
13) 1- Therapy Receptacle O-ring (if damaged or lost during removal)
14) 1- Speaker Isolator (if damaged or lost during removal)

Ordering Info: 1. Total required volume of material by region

___10%___% GSSNA___90%___% GSSI
2. Units available per SPS Warehouse at FCO release date
__0__North America ___0___Europe ____0___Asia Pacific
3. Forecasted time (weeks after FCO release or provide a specific date) when full supply
to meet total FCO demand is available at the SPS Warehouses
_______52______
4. If the Field needs to limit their monthly demand until full supply is available, provide the
X% of total demand per month to be used until the full supply is available at the SPS
Warehouses
__10____% until ______July 2016____(date)
NOTE: Availability of support parts kit (SPK) FCO86100172 will be 4-6 weeks after release
of this FCO. Availability of material to implement this FCO requires the Field to
return exchange PCA’s immediately.

PROCEDURE:
For customers in the United States, the PCMS Q&R group will mail the Field Safety Notice (FSN) to the
customers. Outside the United States, the Key Markets will translate the FSN and mail it to customers.
Steps to complete a Service Work Order (SWO):
Note: Only close SWO if all the hardware updates and software upgrade have been completed.
1. Order parts.
a. For devices without ETCO2 order only order the following:
i. 453564580931 XL+ FCO86100172 SPK
ii. 453564570771 XL+ PCA Therapy Exchange II SPK, Key Component
iii. 453564570781 XL+ PCA Processor Exchange II SPK, Key Component
b. For devices with ETCO2 order the following:
i. 453564580931 XL+ FCO86100172 SPK
ii. 453564570771 XL+ PCA Therapy Exchange II SPK, Key Component
iii. 453564570781 XL+ PCA Processor Exchange II SPK, Key Component
iv. The appropriate Measurement Module with ETCO2 for the device measurement
module option configuration. See “Hardware” section above.
2. Complete hardware update. See “Hardware Update Instructions” section below.
3. Upgrade software to version B.01.00. See “Software Update Instructions” section below.
4. Complete the Verification Procedures as required per XL+ Service Manual, Edition 3
(989803160581).
5. Close the SWO only after completing all hardware updates, software updates and the
Verification Procedures.

(Template Document Number: A-Q2920-00108-T1, Rev. N)

Field Change Order Document Number FCO86100172A Rev. A Page 5of 15
Hardware Update Instructions:
Refer to the HeartStart XL+ Service Manual Edition 3, 989803160581, make sure to only complete the
sections and steps listed below. Unless otherwise noted all steps listed below should be applied to all
devices.
Note: During replacement torque all screws per torque requirements in Service Manual.
WARNING: Any connections that are not seated and latched properly during the device assembly
may become loose over time, causing devices to fail when in use. Check all connections before
closing the device case.
1. Run OP-Check to verify XL+ operation.
2. Remove Handle.
a. RFU-and-USB PCA, page 80
i. Preparation – steps 1-2
ii. Removal - steps 1-2
b. Set aside handle assembly
3. Remove Printer
a. Printer Assembly, page 85
i. Position the device on the work surface with the printer facing you.
ii. Removal – steps 1-4
b. Set aside printer assembly
4. Open the case
a. Separating the Case, page 87
i. To separate the Front and Rear Case from each other – steps 1-8
b. Set aside case
5. Discharge Capacitor
a. Discharging the Therapy Capacitor, page 89
i. To discharge the Therapy Capacitor – steps 1-4
6. Remove Battery PCA
a. Battery PCA, page 116
i. Preparation – steps 2-3
ii. Removal – steps 1-2
1. Note: Figure 75 shows the Battery PCA with the support pad. The Battery
PCA being removed from the device will not have this support pad.
b. Discard Battery PCA and washer.
7. Remove Rear Chassis Shelf
a. Tilting Rear Chassis, page 92
i. To bring the Rear Chassis into the upright position – steps 1-5
b. Rear Chassis Shelf, page 93
i. To remove the Rear Chassis Shelf - step 2-7
1. Note: The Battery PCA has already been removed so instructions
referencing the Battery PCA can be ignored.
c. Set aside Rear Chassis Shelf
8. Remove Rear Chassis
a. Pivoting Rear Chassis Upward, page 122
i. To pivot the Rear Chassis upward – step 4
b. Front Chassis and Case Access, page 134
i. To remove the Rear Chassis – steps 2b-3
c. Place Rear Chassis in front of you with Therapy PCA facing up.
9. Remove and Replace the Therapy PCA
a. Therapy PCA, page 110
i. Removal – steps 1-5
1. Note: Make sure to disconnect and KEEP cable 5, ribbon cable from
Therapy PCA to Processor PCA. See Figure 71 on page 111 for cable
connector location.
ii. Replacement (page 112) – steps 1-3 & 5-6
1. Note: Make sure to install cable 5 to connector J4 on Therapy PCA. See
Figure 71 on page 111 for cable connector location.
10. Remove and Replace the Therapy PCA Power Supply cable
a. Remove Therapy PCA Power Supply cable, see figure 73 on page 113 for location of
cable.
b. Replace Therapy PCA Power Supply cable without ferrite core with the Therapy PCA
Power Supply cable

(Template Document Number: A-Q2920-00108-T1, Rev. N)

Field Change Order Document Number FCO86100172A Rev. A Page 6of 15
 i. See figure 73 on page 113 and Replacement step 4 page 112 for ferrite position
and cable threading through the Rear Chassis.
c. Follow instructions in Parts Disposal Section of this FCO for the Therapy PCA.
11. Remove Rear I/O Assembly
a. Rear I/O Assembly, page 100
b. Set Rear Chassis in front of you with Capacitor to your left.
c. Removal – steps 1-5
i. Note: The Network Cable has already been disconnected from the Processor
PCA when the Rear Chassis was removed, ignore the note in Figure 61
ii. Note: Figure 61 shows cables with ferrite cores. The current cables being
disconnected might not have ferrite cores or might have smaller ferrite cores. Use
the figure as a reference.
d. Discard Rear I/O Assembly
12. Replace Rear I/O Assembly and Install Network Cable
a. Rear I/O Assembly, page 101
i. Replacement - steps 1-4, 5a, 5b, 5d, 6, 8
1. Note: Make sure during step 4c that you install the Network Cable with
the ferrite core on the Rear I/O Assembly included in 453564580931 XL+
FCO86100172 SPK. See figure 61 page 100 for connection location and
ferrite position.

13. Remove Processor PCA

a. Processor PCA, page 135
b. Preparation – steps 4-5
i. Note that the instructions referred to in step 4 include the Therapy Port Extension
assembly which is included as an additional part in this FCO.
c. Removal – steps 1, 3-4.
d. Follow instructions in Parts Disposal Section of this FCO for the Processor PCA.
14. Remove Front Chassis
a. Inverter PCA and Front Chassis, page 144
i. Removal – steps 1-2
15. Remove and Replace Therapy Port Assembly
a. Therapy Port, page 119
i. Removal - steps 2-4
ii. Replacement (page 120) - steps 1a-1d, 1g and step 2
16. Remove and Replace Speaker Assembly
a. Speaker Assembly, page 146
i. Removal and Replacement – steps 1-3
17. Replace ECG Port on the Measurement Module (instructions for devices without ETCO2)
a. Measurement Module without the CO2 Port, page 132
b. Removal - steps 2, 5 & 6.
c. Remove the ECG Port from the Measurement Module see figure 88 on page 132 to
identify the ECG Port location.
d. Slide the ECG Port with the ferrite core on to the Measurement Module see figure 88 on
page 132 to identify the ECG Port location.
e. Replacement - steps 1-9
i. Note: Front Chassis has already been remove. Ignore references to the Front
Chassis in step 9.
18. Replace the ECG/Measurement Module (instructions for devices with ETCO2)
a. Measurement Module with the CO2 Port, page 128
b. Removal - steps 2, 11 & 12.
c. Replacement - steps 1-4
i. Note: Front Chassis has already been remove. Ignore references to the Front
Chassis in step 4.
19. Install Front Chassis
a. Front Chassis Removal and Replacement, page 143
b. Replacement - steps 1a – 1g
20. Replace Processor PCA
a. Processor PCA, page 137
b. Replacement - steps 1-3, 5, 7-8
i. Note: Clock Battery already installed skip step 1.
ii. Note: Make sure no cables are caught underneath Processor PCA.
21. Install Therapy Port Extension
a. Printer PCA, page 125

(Template Document Number: A-Q2920-00108-T1, Rev. N)

Field Change Order Document Number FCO86100172A Rev. A Page 7of 15
 i. Replacement - steps 1-6
1. Note: see figure 74 page 115 for wire position
22. Replace Battery PCA and Support
a. Battery PCA, page 116
i. Replacement - steps 1 & 3
1. Note: Replace with Battery PCA and support pad come as two separate
pieces. See NOTE on page 116 and figure 75 to assemble the Battery
PCA and support before installation.
23. Install Rear Chassis
a. Front Chassis and Case Access, page 134
i. To install Rear Chassis - steps 2-5
24. Install Rear Chassis Shelf
a. Rear Chassis Shelf, page 95
i. To install Rear Chassis Shelf steps 1-6
25. Close the Rear Case
a. Closing the Case, page 151
i. To close the Case steps 1-16
26. Install the Printer
a. Printer Assembly, page 85
i. Replacement - steps 1-4
27. Install Handle
a. Handle Assembly, page 79
i. Replacement - steps 1, 3, 4, 5 and 6
28. Enter Serial Number
a. Entering Serial Number, page 138
i. To enter the serial number, steps 1-7

Software Upgrade Instructions:

The B.01.00 software is available on InCenter and from SPS on a USB drive. If downloading the software from
InCenter, make sure to load all files on a USB 2.0-compatible flash drive, no more than 32 Gb capacity.
Refer to the HeartStart XL+ Service Manual Edition 3, 989803160581, make sure to only complete the
sections and steps listed below. Unless otherwise noted all steps listed below should be applied to all
devices.

1. Upgrade Software to B.01.00

a. Software Upgrades, page 11
i. To install software on the device or to change the device’s language, steps 1-13
2. Enable Options
a. Enabling Options, page 140
i. To enable options, steps 1-8

CAUTION: The process to upgrade the software takes approximately 12 minutes per device. Please
follow all on-screen instructions. DO NOT suspend the upgrade process or remove power during
the upgrade as it may render the device unusable.

Verification Procedure(s):
 Following the hardware service and software upgrade, print the Device Info Report and verify the
software revision displayed under the device serial number is B.01.00, followed by the language. For
example, SW Rev: B.01.00 American English
 Complete Performance Verification Testing as specified in Service Manual and verify pass.

Location Category: Check one. __X__On-site __X__Philips Medical CRC

______Customer Installable ______Remote

(Template Document Number: A-Q2920-00108-T1, Rev. N)

Field Change Order Document Number FCO86100172A Rev. A Page 8of 15
PARTS DISPOSAL:
Return the following exchange parts:
453564570771 XL+ PCA Therapy Exchange II SPK, Key Component
453564570781 XL+ PCA Processor Exchange II SPK, Key Component
All other parts are to be scrapped.

______Return ____Scrap ___X___Other

DOCUMENTATION:

989803160581, HeartStart XL+ Service Manual

EC 2930-2015-06-06803

(Template Document Number: A-Q2920-00108-T1, Rev. N)

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ATTACHMENT B: FCO86100172 Action Notification Report

FCO ACTION NOTIFICATION REPORT (ANR form)

For Key Market use only; do not return to BU/BL.
TITLE: FCO86100172A 861290 HeartStart XL+ Defibrillator Multiple Software and Hardware Issues

CLASSIFICATION: Mandatory FCO REF. NO.: FCO86100172A

APPLIES TO: 861290, HS XL+

HOSPITAL / ADDRESS:

LOCATION / FW SITE NO.: SALES ORDER NO. / OA NO.:

PRODUCT NUMBER:

UNIT SERIAL NUMBER:

ACTION ON THIS UNIT WAS: (select one) JOB NO. / SERVICE INCIDENT NO.:

Completed per instruction on

DATE
Completed by the factory prior to delivery

Not completed as this unit is not affected per instruction because: (state reason)

Not completed because: . . . . . . . . . . . . .

Required parts & instructions are received by the customer

Not completed because customer refuses to install FCO: (state reason)

CUSTOMER ACKNOWLEDGEMENT (Required for MANDATORY ACTIONS only).

The REASON and PURPOSE of this modification has been explained to me.

CUSTOMER NAME (PLEASE PRINT) TITLE

CUSTOMER SIGNATURE DATE

BRANCH SERVICE UNIT /

REGION / SERVICE AREA NO.:
DEALER:

SIGNATURE CUSTOMER SERVICES ENGINEER DATE

SIGNATURE CUSTOMER SERVICES MANAGER MAIL TO: Country Customer Services manager

(Template Document Number: A-Q2920-00108-T1, Rev. N)

Field Change Order Document Number FCO86100172A Rev. A Page 15of 15