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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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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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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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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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)

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6. REMOVING THE SYSTEM/THERAPY PCB
ASSEMBLY (CONTINUED)
6.6 P22 – Lift the PCB assembly and disconnect P22
connector from the PCB Assy, CAP discharge.
Disconnect P22
to PCB ASSY-
CAP Discharge

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6. REMOVING THE SYSTEM/THERAPY PCB
ASSEMBLY (CONTINUED)
6.7 J20 – Continue lifting the assembly and disconnect
Power/Therapy cable.
6.8 Lift the system/therapy board assembly out from the
rear case and set aside per ESD Work Instruction
7000145.
Disconnect J20
Power/Therapy
Cable

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7. Removing the Parameter Bezel
7.1 Disconnect power/therapy cable from J8 on the power
PCB and remove.
7.2 Remove the OEM shield.
Disconnect J8
Power/ Therapy
Cable
Remove OEM
Shield

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7. REMOVING THE PARAMETER BEZEL
(CONTINUED)
7.3 Disconnect the power/contact PCBA, P12 flex cable
from the power board at J12.
7.4 Remove the power/system cable from the power
board at J17.
Disconnect Flex
Cable at J17
Disconnect Power
/Contact PCBA Flex
Cable at J12

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7. REMOVING THE PARAMETER BEZEL
(CONTINUED)
7.5 If present, disconnect the CO2 inlet tube.
7.6 If present, carefully disconnect the CO2 cable
connector from CO2 adapter cable.
7.7 If present, disconnect the NIBP tube at tube fitting.
7.8 If present, carefully disconnect the SpO2 connector
flex cable from J1 of the SpO2 PCB.
CAUTION
POSSIBLE COMPONENT DAMAGE: The SpO2
connector flex cable can be damaged during
disassembly. If SpO2 connector is damaged,
replace the SpO2 flex cable using the Masimo
SpO2 Panel Mount Cable Repair Kit (3305431-
026).
Disconnect CO2
Inlet Tubing
Disconnect CO2
Harness
Disconnect NIBP
Tubing
SPO2 connector
flex cable

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6. REMOVING THE PARAMETER BEZEL
(CONTINUED)
7.9 If present, remove the eight screws and captured
washers (3207337-312) securing the IP connectors
to the parameter bezel.
7.10 If present, remove the IP connectors and seals.
Discard the screws and seals.
Remove screws
from IP Connector
Housings (8 places)
IP Connectors and
seals removed

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8. Installing the Temperature Cable Assembly
8.1 Place the temperature connector and new gasket
into the second connector mounting hole up from the
bottom of the parameter bezel. Secure the
temperature connector with four new screws
(3207337-312). Torque to 6.8 in-lb.
CAUTION
POSSIBLE MOISTURE LEAKAGE: When installing
the cable, use new gasket to help prevent ingress of
fluids.
Gasket
3007998-00
Temperature Connector
Screw
3207337-312
4 places
Note:
Leave
empty
T
O
R
Q
U
E
T
O
R
Q
U
E
T
O
R
Q
U
E
6.8 In-Lb
Install
Connector
as shown
Note:
Align ECG
Ferrite as
shown
before
installation.

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9. Installing the Parameter Bezel
CAUTION
POSSIBLE MOISTURE LEAKAGE: Visually inspect
the mating surfaces between the parameter bezel and
the rear case before and after fastening to ensure that
they are even.
9.1 Clean away any adhesive residue on the parameter
bezel with isopropyl alcohol.
9.2 Place the parameter bezel on the rear case to make
the cable connections.
9.3 If present, connect the NIBP tube to the NIBP
connector fitting and ensure that it is fully seated.
9.4 If present, connect the SpO2 connector cable to SpO2
PCB at J1.
9.5 If present, connect the CO2 inlet tube to the barbed
fitting connected to the CO2 module.
9.6 If present, connect the CO2 connector cable end to
the CO2 adapter cable.
Connect
NIBP tube
Connect
SPO2 cable
Connect
CO2 inlet
tube
Connect
CO2
connector
cable
Place Parameter
bezel on the rear
case

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9. INSTALLING THE PARAMETER BEZEL
(CONTINUED)
NOTE: Ensure the NIBP hose is not pinched by
the ECG brackets or rear case standoff.
NIBP hose movement should be
unrestricted in bezel cavity.
9.7 Reinstall the parameter bezel onto rear case with two
new screws (202253-763). Torque to 6.8 in-lb.
6.8
In-Lb
Screw
202253-763
2 places

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9. INSTALLING THE PARAMETER BEZEL
(CONTINUED)
9.8 Connect the power/contact PCB cable to the power
PCB at J12.
9.9 Connect the power/system cable to the power PCB at
J17.
9.10 Route CO2 wire harness above the power/system
cable as shown and reconnect it.
Connect Contact
PCB Cable P12 to
J12