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Physio Control LIFEPAK 15 V2 User manual

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Title LP15 V2 System Board Reprogramming Process Page 1 of 31
Doc Type
Service Process Document
Doc ID
3339111
Doc Rev
A
Doc State
Released
State Date
1/29/2019
Ref. Product DMR:
Ref. PFMEA:
Ref. PFMEA Rev:
Template: 7000743_B
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
Initial Release.
Doc
ID:
3339111 Rev: ATitle: LP15 V2 System Board Reprogramming Process 2 of 31
Work
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1st
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2
2nd Verify
Tool
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Caution
Shock
Hazard
E
N
S
W
Orient
Clean
Scan
Template: 7000743_B
Purpose:
This instruction guides the Service Depot and Aftermarket Operations operator through the process to allow direct programming of
the FPGA firmware to the system board 3206834 via direct connection in order to recover a bricked system board in a LIFEPAK®
15 version 2 monitor/defibrillator.
Scope:
This document is limited to LIFEPAK 15 V2 monitor/defibrillators, 3306272-All (Version 2), that are “bricked”
These instructions are intended for authorized Service Depot and Aftermarket Operations Technicians who have reviewed the
procedure and who are familiar with the LIFEPAK 15 V2 device and will only be performed in a regional Service Depots. The
LIFEPAK 15 V1/V2 Service Manual and the applicable Performance Inspection Procedure will be used in conjunction with this
Service Process Work Instruction.
Definitions:
Table 1: Definitions, Acronyms, and Abbreviations
Term /
Abbreviation
Definition
“Bricked”
Software has not been loaded correctly into the FPGA.
PIP-TCP
Performance Inspection Procedure – Test and Calibration Procedure. The procedures
used to test a device to ensure that it is within defined specifications.
FPGA
Field Programmable Gate Array
Training:
As a prerequisite, only personnel that have completed training on this LP15 V2 System Board Reprogramming process are
permitted to perform this process on the LIFEPAK 15 V2 device. An individual will be considered fully trained when they meet the
requirements as defined in the Training Work Instruction, 7000045 on the following documents:
•LP15 V2 System Board Reprogramming Process, 3339111
•LP15 V2 System Board FPGA Debrick Programming Procedure, 3339230
•Test Procedure, CAPIP, 3301593 Or Test Procedure, Manual PIP-TCP, LP15,3207841
Doc
ID:
3339111 Rev: ATitle: LP15 V2 System Board Reprogramming Process 3 of 31
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Clean
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Template: 7000743_B
Tools Required: (substitution of equivalent or better equipment allowed)
Computer – Win 7 or 10 software
Fixture, LP15 System Board FPGA Programming (3339034)
Firmware- FPGA, Programmed, LP15 System Board (3207723)
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).
3/8’’ nutdriver
Static-dissipative mat and wrist strap
Fixture Assembly, Capacitor Discharger 3012102 or 2673832.
Tools defined in the LP15 Service Manual, 3300117, Replacement Procedures Tool list
See Tools defined in the PIP - TCP sections of LIFEPAK 15 PIP Test Procedure, 3207841 or in Test Procedure, CAPIP, 3301593
for additional test tools required for performance testing
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:
LP15 V2 System Board FPGA Debrick Programming Procedure 3339230
Instructions for use, Combined Service Configurator Loader 3206073
LIFEPAK 15 PIP/TCP Manual Procedure 3207841
LIFEPAK 15 V1/V2 Service Manual, CD 3309059 (V1/V2)
Work Instructions – CAPIP Test (where applicable) 3301593
Device Compliance Tool (where available) 3316610
Instructions, Setup Mode, LP15, V2, V4 3306226
Doc
ID:
3339111 Rev: ATitle: LP15 V2 System Board Reprogramming Process 4 of 31
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Template: 7000743_B
Materials Required:
The following installed materials associated with this procedure are shown in the table below:
Cat Number
Description
Quantity
21300-007253
SCREW-CAP,SCH,REC T15 TO RX 6-32,0.375L,SS,NYLOK
8
21300-000777
SCREW,SELF-SEAL,SELF-LOC K,6-32X0.375
14
21300-001038
SCREW-M,CS,Z,PH, NYLOCK, 4-40 X .312L
13
21300-007297
SCREW-MACH,PNH,PHH,NYLOC K,4-40,0.312L,WSHR,CS,ZN
1
21300-001038
SCREW-M,CS,Z,PH, NYLOCK, 4-40 X .312L
10
21300-001030
SCREW-PH,NYLOCK,PHIL,SS, #4-40X.1.125L
1
21300-001478
Hex nut
1
21300-001479
Spacer
1
21300-001379
CONN-HDR, SQUAREPIN DUAL ROW AU PLATED, 30 PIN
1
21300-007553
Shield-System PCBA, SBC, Top
1
21300-007554
Shield-System PCBA, SBC, Bottom
1
21501-000152
LABEL-SHOCK HAZARD
1
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3339111 Rev: ATitle: LP15 V2 System Board Reprogramming Process 5 of 31
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Clean
Scan
Template: 7000743_B
1. Initial Power Check
Install a fully charged battery onto the LIFEPAK 15
monitor/defibrillator. Press the ON key. If the screen flashes
white and then becomes blank, the unit is bricked.
2. Disassembling the Case
2.1 Remove all cables and patient connections, and then
remove the batteries.
2.2 If applicable, remove the carrying case.
2.3 Remove the four front mounting screws (REF 21300-
007253) from the bumpers (Torx-15).
2.4 Remove the four rear mounting screws (REF 21300-
007253) from the bumpers (Torx-15).
2.5 Remove the bumpers (REF 21300-007356 and
21300-007010) from the case and set aside.
Remove Screws
(4 places)
Remove Screws
(4 places)
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3339111 Rev: ATitle: LP15 V2 System Board Reprogramming Process 6 of 31
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Clean
Scan
Template: 7000743_B
2. Disassembling the Case (Continued)
2.6 Lay the defibrillator face-down on a protective surface
to prevent damage, and then remove the 14 case
screws (REF 21300-000777). Discard the screws.
2.7 Holding the case halves together, position the device
face-up 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)
Doc
ID:
3339111 Rev: ATitle: LP15 V2 System Board Reprogramming Process 7 of 31
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1st
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2
2nd Verify
Tool
!
Caution
Shock
Hazard
E
N
S
W
Orient
Clean
Scan
Template: 7000743_B
2. Disassembling the Case (Continued)
2.8 Disconnect the P2 system/interface flex cable
connector (REF 21330-001226) form the system PCB
in the rear case.
2.9 Disconnect the P23 therapy ribbon cable connector
(REF 21300-007463) in the front case from the
therapy PCB.
2.10 Disconnect the J24 therapy cable connector from the
P24 transfer relay connector.
2.11 Separate the front and rear cases halves.
Disconnect P2
- System/
Interface Flex
Disconnect
J24 - Therapy
Cable
Disconnect
J23 - Therapy
Ribbon Cable
Doc
ID:
3339111 Rev: ATitle: LP15 V2 System Board Reprogramming Process 8 of 31
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2nd Verify
Tool
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Caution
Shock
Hazard
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N
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W
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Clean
Scan
Template: 7000743_B
2. 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.
2.12 Before continuing any further, discharge the energy
storage capacitor using the discharge tool.
2.13 To use the capacitor discharge tool:
2.13.1 Place one probe on a discharge point and hold it
steady.
2.13.2 Place the other probe on the remaining discharge
point and hold both probes steady.
2.13.3 Observe the neon lamp inside the capacitor
discharge tool. If a charge of approximately 90 volts
is present, the neon lamp will light.
2.13.4 Continue holding the probes on the points indicated
for at least 30 seconds after the neon lamp is no
longer lit.
DISCHARGE
STORAGE
CAPACITOR
Doc
ID:
3339111 Rev: ATitle: LP15 V2 System Board Reprogramming Process 9 of 31
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2
2nd Verify
Tool
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Caution
Shock
Hazard
E
N
S
W
Orient
Clean
Scan
Template: 7000743_B
3. Removing the System (A01)/Therapy (A04)
PCB Assembly
3.1 Disconnect the connectors on the system PCB as
follows:
J1- Press the connector locking tabs and disconnect
the power/system PCB cable (W01, REF 21300-
007456)
J2- (The system/interface PCB Cable was
disconnected during step 3, Disassembling the Case)
J4- Disconnect the USB flex connector (W14, REF
21330-001196)
J6-Disconnect the ECG connector cable (W7, REF
21330-001527)
(If present) J7- Disconnect the IP connector of the IP
wire harness (W33, REF 21300-001583)
(if present) J7- Disconnect the temperature connector
of the temperature cable (W35, REF 21330-001522)
J106 (A22 biphasic PCB)- Disconnect the MTE cable
from the biphasic PCB (W20, REF 21300-007670)
Disconnect
PWR/ SYS Cable
(J1)
Disconnect ECG and
IP Option (if present)
connectors.
(J6, J7)
Disconnect USB
Flex Connector
(J4)
Disconnect MTE
Flex from J106
Doc
ID:
3339111 Rev: ATitle: LP15 V2 System Board Reprogramming Process 10 of 31
Work
1
1st
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2
2nd Verify
Tool
!
Caution
Shock
Hazard
E
N
S
W
Orient
Clean
Scan
Template: 7000743_B
3. Removing the System (A01)/Therapy (A04) PCB
Assembly (Continued)
3.2 Remove the seven screws (REF 21300-001038) and
one screw with washer (REF 21300-007297) that
secure the system PCB to the rear case. Discard the
screws.
Note: The screw that is in the ECG shield can easily
be missed as part of screw removal. Ensure that all
screws are removed prior to lifting the system/therapy
PCB assembly.
3.3 Set the rear case upright and move the
system/therapy PCB assembly towards the front of
the case to gain access to the rear therapy PCB
connectors.
3.4 Disconnect the transfer relay (REF 21330-000920)
from the therapy PCB at J22.
3.5 Disconnect the transfer relay (REF 21330-000920)
from the therapy PCB at J21.
Disconnect
Transfer Relay
(J21)
Disconnect
Red & Black
Cable (J22)
Remove
screws
(7 places)
Remove
screw with
cap. washer
(1 place)