Physio Control LIFEPAK 15 V4 User manual

Title Service Process Work Instruction LIFEPAK 15 V4 CO2 Upgrade Page 1 of 38
Doc Type
Service Process Document
Doc ID
3333964
Doc Rev
A
Doc State
Released
State Date
3/22/2018
Reference Product DMR:
3313182
7000743_A.doc
This document is electronically signed in the Physio-Control, Inc. Product Lifecycle Management (PLM) System. Approvals can be
obtained from the PLM system which displays the selected approvers, their approval roles, and approval dates.
PROPRIETARY AND CONFIDENTIAL DOCUMENT FOR PHYSIO-CONTROL, INC. USE ONLY. This document is property of Physio-
Control and may not be used, reproduced, published or disclosed to others without authorization from Physio-Control.
Owner
Corporate
Attachments (Optional):
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Pages
Page Sequencing
Change Description
Initial release.

Title Service Process Work Instruction LIFEPAK 15 V4 CO2 Upgrade Page 2 of 38
Doc Type
Service Process Document
Doc ID
3333964
Doc Rev
A
Doc State
Released
State Date
3/22/2018
Reference Product DMR:
3313182
7000743_A.doc
Purpose:
This instruction guides the Field Service Representative through the update process to add the CO2 feature to a LIFEPAK®15 version 4
monitor/defibrillator.
Scope:
This upgrade is for 3313182-All (Version 4), LIFEPAK 15 V4 monitor/defibrillators that do not previously have the End-Tidal Carbon Dioxide (CO2)
monitoring feature installed.
These instructions are intended for authorized field service personnel who have reviewed the upgrade procedure and who are familiar with the
LIFEPAK 15 device. The LIFEPAK 15 V4 Service Manual and the applicable Performance Inspection Procedure will be used in conjunction with this
Service Upgrade Process Work Instruction.
When installing multiple upgrades into a LIFEPAK 15 V4, the CO2upgrade should be the first upgrade installed.
All upgrades that include V4 software have the voice recorder enabled. This will be performed using the Combined Software Configurator Loader
(CSCL) configuration steps at the end of this upgrade.
Training:
As a prerequisite, only personnel that have completed LIFEPAK 15 V4 monitor/defibrillator repair training are allowed to perform this upgrade on a
LIFEPAK 15 V4 device. An individual will be considered fully trained when they meet the prerequisite, and read and understand of this document in
the Quality Management System (QMS).
Tools Required: (substitution of equivalent or better equipment allowed)
Computer – Win 7, equivalent or better.
LIFEPAK 15 To PC Interconnect Cable 11230-000005, 11230-000020, or 11996-000369.
Torque Driver – Hand Operation, with an adjustable range of 5 – 12 in-lbs.
Driver Bits – P1 (2”minimum shaft), P2 (5” minimum shaft), Torx, T-15 (2” minimum shaft).
Fixture Assembly, Capacitor Discharger 3012102 or 2673832.
Tools defined in the PIP - TCP sections of LIFEPAK 15 PIP Test Procedure, 3207841 or in Test Procedure, CAPIP, 3301593.
All tools requiring calibration should be calibrated and within their calibration cycle dates.
•Torque Driver conversions – 4 in-lbs. = 45 cNm, 6.8 in-lbs. = 77 cNm, 10 in-lbs. = 113 cNm
Documentation Required:
AHA Software Update Instruction 3333250
Instructions for use, Combined Service Configurator Loader 3206073
LIFEPAK 15 PIP/TCP Manual Procedure 3207841

Title Service Process Work Instruction LIFEPAK 15 V4 CO2 Upgrade Page 3 of 38
Doc Type
Service Process Document
Doc ID
3333964
Doc Rev
A
Doc State
Released
State Date
3/22/2018
Reference Product DMR:
3313182
7000743_A.doc
LIFEPAK 15 Service Manual, CD 3316924 (V4)
Work Instructions – CAPIP Test (where applicable) 3301593
Device Compliance Tool (where available) 3316610
Instructions, Setup Mode, LP15, V2, V4 3306226
Materials Required:
Kit – Upgrade, CO2 For LP15 V1, V2, V4, ROHS 43998-000007

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ID:
3333964 Rev: ATitle: Service Process Work Instruction LIFEPAK 15 V4 CO2 Upgrade 4 of 38
Work
1
1
st
Verify
2
2nd Verify Tool
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Caution
Shock
Hazard
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N
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Orient Clean Scan
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1. Verify the Device Serial Number
Verify that the device’s serial number label matches the serial
number listed in the upgrade kit documentation.
2. Initial Power-Up Check
Install a fully charged battery onto the LIFEPAK 15
monitor/defibrillator. Press the ON key. Verify that the device
powers up with no service indicator light. If the service
indicator light is illuminated, do not proceed with this
upgrade, and repair according to the appropriate LIFEPAK
15 monitor/defibrillator repair process. If the service indicator
light is not illuminated, continue with the upgrade.
3. Downloading Device Data (Pre-Service Report
Download)
NOTE: For International, Use your normal service reporting
process to document the service activity.
3.1 Perform a Pre-download before proceeding with the
upgrade using the Device Compliance Tool (DCT).
3.2 Turn the device off.

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4. Disassembling the Case
4.1 If applicable, remove carrying case.
4.2 Remove all cables and patient connections, and then
remove the batteries.
4.3 Remove and discard the four front mounting screws
(21300-007253) from the bumpers (Torx-15).
4.4 Remove and discard the four rear mounting screws
(21300-007253) from the bumpers (Torx-15).
4.5 Remove the bumpers (21300-007356 and 21300-
007010) from the case and set aside.
Remove Screws
(4 places)
Remove Screws
(4 places)

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2nd Verify Tool
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4. Disassembling the Case (continued)
4.6 Lay the defibrillator face down on a protective
surface to prevent damage, and then remove the
14 case screws (21300-000777). Discard the
screws.
4.7 Holding the case halves together, position the device on
your work surface. Lift the front case assembly slightly
above the rear to access the connecting cables.
Remove Screws
(7 places)
Remove Screws
(5 places)
Remove Screws
(2 places)

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2
2nd Verify Tool
!
Caution
Shock
Hazard
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N
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Orient Clean Scan
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4. Disassembling the Case (continued)
4.8 Disconnect the P2 system/interface flex cable
connector (W04) from the system PCB in the rear case.
4.9 Disconnect the P23 therapy ribbon cable connector
(W11) in the front case from the from the therapy PCB.
4.10Disconnect the P21 therapy cable connector (W11) from
the Therapy PCBA.
4.11Separate the front and rear case halves.
Disconnect P2 –
System/Interface
Flex. Lift
connector tab to
disconnect cable.
Disconnect
Therapy Cable
Disconnect
Therapy Ribbon
Cable

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2nd Verify Tool
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Shock
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4. Disassembling the Case (continued)
DANGER
SHOCK HAZARD: Lethal voltages may be present even
without operator action. Always discharge the energy
storage capacitor prior to servicing.
4.12Before continuing any further, discharge the energy
storage capacitor using the discharge tool.
4.13 To use the capacitor discharge tool:
4.13.1 Place one probe on a discharge point and hold it
steady.
4.13.2 Place the other probe on the remaining discharge
point and hold both probes steady.
4.13.3 Observe the neon lamp inside the capacitor discharge
tool. If a charge of approximately 90 volts is present,
the neon lamp will light.
4.13.4 Continue holding the probes on the points indicated
for at least 30 seconds after the neon lamp is no
longer lit.
DISCHARGE
STORAGE
CAPACITOR

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2nd Verify Tool
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Shock
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N
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Orient Clean Scan
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5. Removing the Parameter Bezel from rear case.
5.1 Remove the parameter bezel label from the bezel and
discard.
5.2 Remove and discard the CO2 spacer label (21300-
007362) from Bezel.
5.3 Remove the two bezel mounting screws (21300-006965).
Discard the screws.
5.4 Disconnect the ECG connector cable, J6.
5.5 If present, disconnect the IP connector cable of the IP wire
harness, J7.
5.6If present, disconnect the temperature connector of the
temperature cable (W35) J7.
5.7 Lift out the parameter bezel (21330-001211) from the rear
case.
Remove
Parameter
Bezel Label
Remove
Screws
(2 places)
Remove CO2
Spacer Label
21300-007362
Disconnect J6 and
J7 (if present)
Connectors
Parameter
Bezel
21330-001211

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2
2nd Verify Tool
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Caution
Shock
Hazard
E
N
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W
Orient Clean Scan
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6. Removing the System/Therapy PCB Assembly
6.1 J1 – Press the connector locking tabs and disconnect the
power/system PCB cable (W01).
6.2 J4 – Disconnect the USB flex connector (W14).
6.3 Remove the seven screws (21300-001038) and three
screws with washer (21300-007297) that secures the
system PCB to the rear case. Discard all screws and
washers.
Note: The screw that is in the EMI shield can easily be missed
as part of screw removal. Ensure that all screws are removed
prior to lifting the system/therapy PCB assembly.
Disconnect J4
USB Flex
Connector
Disconnect J1
Power/ System
Cable
Remove screw
with cap. washer
(3 places)
Remove
screws
(7 places)