Physio Control LIFEPAK 15 V4 User manual

Title Service Process Work Instruction LIFEPAK 15 V4 Temperature Upgrade Page 1 of 30
Doc Type
Service Process Document
Doc ID
3330371
Doc Rev
B
Doc State
Released
State Date
7/24/2017
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):
Qty
Pages
Page Sequencing
Change Description
Revised release. Process optimized, as a result of define and characterization performed.
•Section 4.7 removed face-up orientation.
•Section 5 process step order changed to Removing the Parameter Bezel Label.
•Section 9. Revised images to optimize the Bezel placement.
•Section 11.2 added missing process step Connect the P21 therapy cable connector from the front case to J21 of therapy PCB.
•Minor grammatical and numerical revisions throughout the document. See redlines for detailed changes.

Title Service Process Work Instruction LIFEPAK 15 V4 Temperature Upgrade Page 2 of 30
Doc Type
Service Process Document
Doc ID
3330371
Doc Rev
B
Doc State
Released
State Date
7/24/2017
Reference Product DMR:
3313182
7000743_A.doc
Purpose:
This instruction guides the Field Service Representative through the update process to add the temperature feature to a LIFEPAK®15 version 4
monitor/defibrillator.
Scope:
This upgrade is for 3313182-XXX (Version 4), LIFEPAK 15 monitor/defibrillators that do not previously have the Temperature 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.
If the Invasive Pressure (IP) feature is installed, it must be removed before the device can be upgraded to add Temperature feature. Temperature
cannot be installed in conjunction with the IP feature.
When installing multiple upgrades into a LIFEPAK 15, the Temperature upgrade should be the last upgrade installed.
All upgrades that include V4 software have the voice recorder enabled. The Temperature setting will also be 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 a LIFEPAK 15 monitor/defibrillator repair training class are allowed to perform this update on a
LIFEPAK 15 device. An individual will be considered fully trained when they meet the prerequisite, and read and understand of this document. Once
this task is performed the individual has completed training. A documented training record will be retained.
Tools Required: (substitution of equivalent or better equipment allowed)
Computer –Win 7.
LIFEPAK 15 To PC Interconnect Cable 3009817-00, 3009817-002 or 3206665-010.
Torque Driver – Hand Operation, with an adjustable range of 5 – 12 in-lb.
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.
All tools requiring calibration should be calibrated and within their calibration cycle dates.
•Torque Driver conversions – 4 lb-in = 64 in-oz = 45 cNm, 6.8 lb-in = 77 cNm, 10 lb-in = 113 cNm
Documentation Required:
Instructions – Installation, Software, Combined Loader 3206073
LIFEPAK 15 PIP/TCP Manual Procedure 3207841
LIFEPAK 15 Service Manual, CD 3316924 (V4)

Title Service Process Work Instruction LIFEPAK 15 V4 Temperature Upgrade Page 3 of 30
Doc Type
Service Process Document
Doc ID
3330371
Doc Rev
B
Doc State
Released
State Date
7/24/2017
Reference Product DMR:
3313182
7000743_A.doc
Work Instructions – CAPIP Test (where applicable) 3301593
Device Compliance Tool 3316610
Materials Required:
Part Number
Description
Qty
Part used in V4
update or all
devices
3305642-XXX
LABEL SET-(configured per kit)
1
All
3319355-000
CABLE ASSEMBLY – TEMPERATURE ROHS
1
V4
3207361-375
SCREW-CAP,SCH,REC 15IP TORX PLUS,6-32,0.375L,SS
8
All
201407-069
SCREW,SELF-SEAL,SELF-LOCK,6-32X0.375
14
All
202253-761
SCREW -M,CS,Z,PH, NYLOCK, 4-40 X .312L 12
7
All
202253-763
SCREW,MACHINE,PANHEAD,NYLOK,4-40 X .437
2
All
3207337-312
SCREW -MACH,PNH,PHH,NYLOCK,4-40,0.312L,WSHR,CS,ZN
7
All
3007998-00
GASKET-CO N N ECTO R,IN VASIVE PRESU RE
1
All
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, power off the
device, remove the battery and continue with the upgrade.
3. Downloading Device Data (Pre-Service Report Download)
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 the four front mounting screws (3207361-
375) from the bumpers. (Torx-15)
4.4 Remove the four rear mounting screws (3207361-
375) from the bumpers. (Torx-15)
4.5 Remove the lower left and lower right guards from
the case and set aside.
Remove Screws
(4 places)
Remove Screws
(4 places)

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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 (201407-069). 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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3330371 Rev: BTitle: Service Process Work Instruction LIFEPAK 15 V4 Temperature Upgrade 6 of 30
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4. DISASSEMBLING THE CASE (CONTINUED)
4.8 Disconnect the P2 system/interface flex cable
connector from the system PCB.
4.9 Disconnect the therapy ribbon cable connector
from the from the therapy PCB.
4.10 Disconnect the therapy cable connector from
Therapy PCBA.
4.11 Separate 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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3330371 Rev: BTitle: Service Process Work Instruction LIFEPAK 15 V4 Temperature Upgrade 7 of 30
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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.
4.12 Before continuing any further, discharge the
energy storage capacitor using the discharge
tool.
DISCHARGE
STORAGE
CAPACITOR

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3330371 Rev: BTitle: Service Process Work Instruction LIFEPAK 15 V4 Temperature Upgrade 8 of 30
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5. REMOVING THE PARAMETER BEZEL LABEL
5.1 If present, remove the CO2 door.
5.2 Remove the parameter bezel label from the bezel and
discard.
5.3 Remove the two bezel mounting screws (202253-
763). Discard the screws.
Note: (Option step - bezel can be rotated in-place to
removeJ1 Power/System Cable and J4 USB Flex
Connector).
Remove Label
and CO2 Door
as required
Remove Screws
(2 places)

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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.
6.2 J4 – Disconnect the USB flex connector.
6.3 J6 – Disconnect the ECG connector cable.
6.4 J7 –
Disconnect the IP connector cable of the IP
wire harness (if present).
Disconnect J4
USB Flex
Connector
Disconnect J1
Power/ System
Cable
Disconnect J6 ECG
and J7 IP (if present)
Connectors

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3330371 Rev: BTitle: Service Process Work Instruction LIFEPAK 15 V4 Temperature Upgrade 10 of 30
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6. REMOVING THE SYSTEM/THERAPY PCB
ASSEMBLY (CONTINUED)
6.5 Remove the seven screws (202253-761) and three
screws with washer (3207337-312) that secures the
system PCB to the rear case. Discard the screws.
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.
Remove screw
with cap. washer
(3 places)
Remove
screws
(7 places)