lifepak 15 monitor defibrillator spo2 upgrade · title lifepak 15 monitor defibrillator spo2...

Title LIFEPAK 15 Monitor Defibrillator SpO2 Upgrade of 26

Doc Type Service Process Document Doc ID 3308213 Doc Rev A

Doc State Released State Date 09/08/2011

Owner Corporate

Attachments (Optional): Qty Pages Page

Sequencing

Change Description

Create field service update of the LIFEPAK 15 Monitor/Defibrillator to add SpO2 capability

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.




Purpose:

This instruction guides the Field Service Representative through the update process to add the Masimo SpO2 feature to a LIFEPAK® 15 monitor/defibrillator.

Scope:

This upgrade is for 3206720-All (Version 1) and 3306272-All (Version 2) LIFEPAK 15 monitor/defibrillators that do not have Masimo SpO2 feature installed. This upgrade doesn’t include the SpO2/CO or SpO2/ Met features. Refer to upgrade instruction 3308221 for these features.

These instructions are intended for authorized field service personnel who have reviewed the upgrade procedure and who are familiar with the LIFEPAK 15 device.

Training: As a prerequisite, only personnel that have completed LIFEPAK 15 monitor/defibrillator repair training are allowed to perform this upgrade on a LIFEPAK 15 device. An individual will be considered fully trained when they meet the prerequisite, and read and understand this document. Once this task is performed the individual has completed training. A documented training record will be retained.

Tools Required: (substitute of equivalent or better equipment allowed)

Computer – XP operating system LIFEPAK 15 To PC Interconnect Cable 3009817-00 or 3009817-002 Torque Driver – Hand Operation, with an adjustable range of 5–12 in-lb. Torque Driver – Hand Operation, with an adjustable range of 32–64 in-oz. Driver Bits – P1 (2” minimum shaft), P2 (5” minimum shaft), Torx, T- 10 and T-15 (2” minimum shaft) Tools called out in the PIP - TCP sections of LIFEPAK 15 Monitor/Defibrillator PIP Test Procedure All tools requiring calibration should be calibrated and within their calibration cycle dates.

Torque Driver conversions – 2 lb-in = 32 in-oz = 22.5 cNm, 4 lb-in = 64 in-oz = 45 cNm, 6.8 lb-in = 77cNm, 10 lb-in = 113 cNm

Documentation Required:

Instructions – Installation, Software, Combined Loader P/N 3206073 revision N or greater LIFEPAK 15 PIP/TCP Procedure P/N 3207841 revision D or greater LIFEPAK 15 Service Manual, CD P/N 3208091-000 (V1) or 3309059-000 (V1/V2) Work Instructions – CAPIP Test P/N 3301593.C or greater




Materials Required:

Part Number Description Qty

3207813-XXX Or 3305642-XXX

(V1) LABEL SET-(configured per kit) (V2) LABEL SET-(configured per kit) 1

3207034 MODULE-OEM, PULSE OXIMETER, MX-1 1

3206962-001 BRACKET – MOUNTING, SPO2 MODULE 1

3207000 ASSY-CABLE, FLEX, SPO2, OEM, PCB 1

3206995 CABLE ASSY – FLEX, SPO2, MASIMO 1

3207009-000 HOUSING-FERRITE, SPO2 1

202253-760 SCREW-M-PH, NYLOK,CS,4-40,.250L 5

3207359-000 LABEL, SPO2 MASIMO PATENT 1

3205311-001 SCREW-MACHINE, PAN, TORX, NYLOK, 4-40, .6875L 4

3207361-375 SCREW-CAP,SCH,REC 15IP TORX PLUS,6-32,0.375L,SS 8

201407-069 SCREW,SELF-SEAL,SELF-LOCK,6-32 X 0.375 14

202253-761 SCREW-M,CS,Z,PH, NYLOCK, 4-40 X .312L 12 7

3207337-312 SCREW-MACH,PNH,PHH,NYLOCK,4-40,0.312L,WSHR,CS,ZN 1

202253-763 SCREW,MACHINE,PANHEAD,NYLOK,4-40 X .437 2

202253-764 SCREW,MACHINE,PANHEAD,NYLOK,4-40 X .500 2

Warnings and Cautions:

LETHAL VOLTAGES MAY BE PRESENT INSIDE THIS DEVICE. THE STORAGE CAPACITOR MUST BE DISCHARGED PRIOR TO PERFORMING ANY WORK WITHIN THE REAR CASE ASSEMBLY.

FAILURE TO DISCHARGE THE STORAGE CAPACITOR MAY RESULT IN INJURY OR DEATH.

General Requirements:

Unless specifically noted, all removed fasteners are to be discarded and new fasteners used for reassembly.

All removed parts with adhesive backing are to be discarded and new parts used for reassembly.

Unless specifically noted, all removed parts, except fasteners and adhesive backed parts, are to be kept with the device being upgraded and re-used to reassemble the device.

Inspect all removed components for damage during disassembly and replace all damaged parts with new parts.




Work Instruction Icon Definitions:

Work Content

1

1st

Person Verify

Torque !

Caution

Shock Hazard

E

N

S

W

Orient

Clean

Work Content: The value add activity being done at the operation. Create a text box in this color to highlight the parts being added.

1st Person Verify: Checking a person’s own work. This can be added as part of a pair of verifications driven from risk assessment or can be called out by itself based upon some business need. Good verification practice involves multiple senses (usually touch and look).

Torque: Use with any fastener that has a specific torque specification. Call out the specific torque requirement in association with this symbol (measure and units). A fastener can be screws, bolts, nuts, or another mechanical fastening device.

Caution: When a specific operation requires extra attention. It can be something that is challenging to perform, has a higher likelihood of being performed incorrectly, or could present some level of risk to the person performing the process.

Shock Hazard: When a person is exposed to something that contains electrical energy. Most likely during disassembly after a unit has been energized.

Orient: When the orientation of the part matters and it could be assembled multiple ways. Making sure that labeling is readable is the most common example.

Clean: For cosmetics or for adhesive preparation. The default cleaning material is chem-wipes. Call out if any additional materials are to be used (such as alcohol) and the purpose of the cleaning.

1. Verify the Device Serial Number

Verify that 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 per 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 upgrade.

3. Downloading Device Data (Pre-Service Report Download)

FOR INTERNATIONAL, Use your normal service reporting process to document the service activity.

Open a service report and download the device data to the service report before proceeding with disassembly of the device.

TORQUE

TORQUE

TORQUEXX.X In-Lb




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 bumpers (3207307-001 and 3206968-000) from the case and set aside.

Remove Screws

(4 places)

Remove Screws (4 places)




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 face-up on your work surface. Lift the front case assembly slightly above the rear to access the connecting cables.

DANGER

SHOCK HAZARD Lethal voltages may be present even without operator action. Always discharge the energy storage capacitor prior to servicing. See the

service manual “Capacitor Discharging Procedure”

for detailed instructions

Remove Screws

(7 places)

Remove Screws

(2 places)

Remove Screws

(5 places)





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 therapy PCB.

4.10 Disconnect the J24 therapy cable connector (W11) from the P24 transfer relay connector (A13).

4.11 Separate the front and rear cases halves.

Disconnect P30 – System/

Interface Flex

Disconnect P2 – System/Interface Flex (W04). Lift connector tab to disconnect cable.

Disconnect J24 - Therapy

Cable (W11)

Disconnect P23 - Therapy Ribbon Cable

(W11)





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 (see LIFEPAK 15 service manual section ‘Capacitor Discharging Procedure’).

NOTE: You may need to disconnect the P51 connector of W20 from the therapy PCB to gain access to discharge points.

4.12.1 Place one probe on a discharge point and hold it steady.

4.12.2 Place the other probe on the remaining discharge point and hold both probes steady.

4.12.3 Observe the neon lamp inside the capacitor discharge tool. If a charge of approximately 90 volts is present, the neon lamp will light.

4.12.4 Continue holding the probes on the points indicated for at least 30 seconds after the neon lamp is no longer lit.

DISCHARGE STORAGE

CAPACITOR




5. Removing the System (A01)/Therapy (A04) PCB Assembly

5.1 Disconnect the connectors on the system PCB as follows:

5.1.1 J1 - Press the connector locking tabs and disconnect the power/system PCB cable (W01).

5.1.2 (The system/interface PCB cable was disconnected during case disassembly).

5.1.3 J4 - Disconnect the USB flex connector (W14).

5.1.4 J6 – Disconnect the ECG connector cable (W7).

5.1.5 J7 - Disconnect the IP/Temp connector cable of the IP/Temp wire harness (W33 or W35) (if present).

5.1.6 J106 (on A22 biphasic module) - Disconnect the biphasic to therapy cable from the biphasic PCB (W20).

Disconnect J4 USB Flex

Connector (W14)

Disconnect J6 ECG and J7 IP/ Temp (if

present) connectors. (W7 & W33)

Disconnect J1 PWR/ SYS Cable

(W01)

Disconnect J106 BTE cable

connector (W20)




5. Removing the System (A01)/Therapy (A04) PCB Assembly (continued)

5.2 Remove the seven screws (202253-761) and one screw with washer (3207337-312) that secured 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.

5.3 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.

5.4 Disconnect the J22 transfer relay from the therapy board.

5.5 Disconnect the J21 transfer relay from the therapy board.

Disconnect J22 Red &

Black Cable (A13)

Disconnect J21 Transfer Relay

(A13)

Remove screw with

cap. washer (1 place)

Remove screws

(7 places)




5. Removing the System (A01)/Therapy (A04) PCB Assembly (continued)

5.6 Continue lifting the assembly. Disconnect the following connectors on the therapy PCB in the following order:

5.6.1 J18 – Disconnect transfer relay assembly connector (A13).

5.6.2 J19 – Disconnect energy storage capacitor connector (A15).

5.6.3 J20 – Disconnect Power/PCB therapy cable (W02).

5.7 Lift the system/therapy board assembly out from the rear case. Turn the system/therapy board assembly over to expose the therapy board.

5.8 Immediately discharge the pacing capacitor as described in LIFEPAK 15 Service Manual section, ‘Discharging the C15 Pacing Capacitor’. The discharge points are located at resistors R5 and R20 on the therapy board.

Disconnect J19 Capacitor

(A15)

Disconnect J18 Transfer Relay (A13)

Disconnect J20 Power /

Therapy (W02)




6. Removing the OEM Shield

6.1 Disconnect Power Therapy Cable (W02) from J8 on the power PCB.

6.2 Remove the OEM shield (3208298).

Disconnect J8 Power/ Therapy

Cable (W02)

Remove OEM Shield




7. Removing the Parameter Bezel

7.1 Disconnect the power/contact PCB (W05) from the power board J12.

7.2 Remove the power/system cable (W01) from the power board J17.

7.3 If present, disconnect the CO2 inlet tube.

7.4 If present, carefully disconnect the CO2 cable connector (W28) from CO2 adapter cable (W30).

7.5 If present, disconnect the NIBP tube at tube fitting.

7.6 If present, remove the CO2 door.

7.7 Remove the parameter bezel label from the bezel.

7.8 Remove the two bezel mounting screws. Discard the screws.

7.9 Lift out the parameter bezel (3206723-005) from the rear case.

Remove Screws

(2 places)

Disconnect J12 PWR/Contact cable (W05)

Disconnect J17 PWR/System cable (W01)

Remove Parameter

Bezel Label




8. Installing the SpO2 Connector Flex Cable (W22)

8.1 Carefully rotate the Parameter Bezel as shown.

Note: If the device has only ECG and no other parameters, the Parameter Bezel can be completely removed.

8.2 Fold SpO2 connector cable (W22) over the top of the ferrite bead and then position the ferrite bead behind the connector.

8.3 Install the ferrite housing (3207009-000) over the flex cable and ferrite bead.

8.4 Insert the SpO2 connector cable into the parameter bezel and secure with the four new screws (3205311-001); torque to 32 in-oz using a Torx T-10 bit .

SpO2 Connector Location

Flex Cable with Ferrite

3206995

Screw 3205311-001

4 places

Ferrite Housing

3207009-000

T O R Q U E T O R Q U E T O R Q U E 32 In-Oz




9. Installing the Parameter Bezel

Observe the following:

Clean away any adhesive residue on the parameter bezel with isopropyl alcohol.

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 Place the parameter bezel above the rear case to make the cable connections.

9.2 If present, route NIBP tube through opening in power PCB bracket next to the J9 connector, power PCB.

9.3 Route the SpO2 connector cable (W22) around end of Power PCB .

9.4 If present, route W28 CO2 inlet tube and cable around end of Power PCB and above SpO2 cable.

9.5 Reinstall the parameter bezel onto rear case with two new screws (202253-763), torque to 6.8 in-lb.

CAUTION

Ensure the NIBP hose isn't pinched by the ECG Brackets or rear case standoff. NIBP hose movement should be unrestricted in bezel cavity.

Screw 202253-763 (2 places)

Route CO2 Inlet Cable and Tubing around edge of Power PCB

and above SpO2 cable

T O R Q U E T O R Q U E T O R Q U E 6.8 In-Lb

NIBP hose

routing




10. Installing SpO2 Module on Mounting Bracket into rear case

10.1 Attach the SpO2 module to the bracket (3206962) using four new screws (202253-760). Torque to 64 in-oz.

10.1.1 Note the module serial number for documentation.

10.2 Attach the SpO2/OEM flex cable (W21) to the SpO2 module using one new screw (202253-760). Torque to 64 in-oz.

SPO2 Module 3207034

Bracket 3206962

Screw 202253-760 (4 places)

SPO2 Flex Cable

3207000

Screw 202253-760

(1 place)

T O R Q U E T O R Q U E T O R Q U E 64 In-Oz




10. Installing SpO2 Module on Mounting Bracket into rear case (continued)

10.3 Connect the SpO2 connector flex cable (W22) to J1 of the SpO2 PCB. Route excess flex cable behind power board.

10.4 Install the mounting bracket (3206962) using two new screws (202253-764). Torque to 6.8 in-lb.

10.5 Connect the SpO2/OEM cable (W21) to the OEM PCB J26.


Screw 202253-764

(2 places)

Connect W22 SPO2

Flex Cable

Connect W21 SPO2/OEM cable




11. Installing the OEM Shield and Power cables

11.1 Connect the power/contact cable (W05) to the power PCB J12.

11.2 Connect the power/system cable (W01) to the power PCB J17.

NOTE: The W01 - power/system PCB cable is under the OEM shield.

11.3 Install the OEM shield (3208298-000).

11.4 Connect the W02 - power/therapy PCB cable (3009726) to J8 on the power PCB.

11.5 Route the left side of the OEM shield under the power/therapy cable J8 connector and over the top of J11, J13 and J15 connectors on power PCB.

PWR/Therapy Cable

3009726-05 (W02)

OEM Shield 3208298

Power/System Cable 3207692

(W01)

Power/Contact Cable 3207692

(W05)

Route CO2 Wire Harness As

Shown




12. Installing the System (A01)/Therapy (A04) PCB Assembly

To install the system/therapy PCB:

12.1 Line up the system/therapy assembly with rear case.

12.2 Connect the W14 - USB flex cable (3206966) to J4 of the system PCB.

12.3 Connect the W01 - power/system cable to J1 of system PCB.

12.4 Connect the W02 - power/therapy cable from the power PCB P20 (3009726) to J20 of the therapy PCB.

12.5 Connect the 5-pin connector from the A13 - transfer relay P18 to J18 of the therapy PCB.

12.6 Connect the 5-pin connector from the A15 - energy capacitor to J19 of the therapy PCB.

Connect J4 USB Flex (W14)

Connect J1 Power/System

Cable (W01)

Connect J20 Power/Therapy

Cable (W02)

Connect J18 Transfer Relay

Cable (A13) and J19 Energy Cap

Cable (A15)




12. Installing the System (A01)/Therapy (A04) PCB Assembly (continued)

12.7 Connect the 5-pin connector from the A13 - transfer relay P21 to J21 of the therapy PCB.

12.8 Connect the 2-pin connector (red & black wires) from the A13 - transfer relay to J22 of the therapy PCB.

WARNING

POSSIBLE INABILITY TO DELIVER THERAPY: Visually inspect to ensure that P22 is fully inserted into the J22 connector.

Connect J21 Transfer Relay

Cable (A13)

Connect J22 2-Pin

Transfer Relay Cable

(A13)





12.9 Connect the W20 - flex cable from the therapy PCB J51 to the biphasic PCB at J106.

12.10 Line up the system PCB with the inserts in the rear case, and secure with seven new screws (202253-761). Torque 6.8 in-lb.

12.11 Capture the ground strap from the EMI Shield with one new screw with washer (3207337-312). Torque 6.8 in-lb.

NOTE: The screw in the ECG shield can be mis-positioned. Check to ensure that the screw is installed and torqued.

Screws 202253-761 (7 places)


Screw w/ Captive Washer

3207337-312 Connect J106

BTE Flex (W20)

1





12.12 Connect the W07 - ECG cable from the parameter bezel to J6 of the system PCB.

12.13 If present, connect the W33 - IP cable from the parameter bezel to J7 of the system PCB.

12.14 If present, connect the W35 - temperature cable from the parameter bezel to J7 of the system PCB.

NOTE: Route wires: ECG behind the connector and IP/Temp in front of connector to reduce possible cable pinch with the front case.

Connect J6 ECG cable (W07)

Connect J7 IP cable (W33)




13. Reassembling the Case

To reassemble the case halves:

13.1 Position the front case over the rear case.

13.2 Connect the P23 therapy ribbon cable connector (W11) (3207044) from the front case to J23 of therapy PCB.

13.3 Connect the J24 6-pin block therapy cable connector (W11) to P24 transfer relay connector (A13).

13.4 Carefully connect the P2 system/interface flex cable connector (W04) (3206991) to the system PCB in the rear case.

13.5 Ensure the case seal is in place in the groove along outside edge of front case. Fold the front and rear case halves together. Route the therapy cable wires away from the edge of the case to avoid pinching.

CAUTION

POSSIBLE COMPONENT DAMAGE - Ensure the therapy cable wires are routed away from the edge of case to avoid wire pinching.

POSSIBLE MOISTURE LEAKAGE - Visually inspect the mating surfaces between the front and the rear case halves before and after fastening them together to ensure that they are even.

PREVENT VIBRATION DAMAGE - In order to meet vibration specifications (for example, prevent loosening of case screws), use new screws (201407-069) when assembling the case and torque to specified value.

Connect J24 Therapy

cable (W11)

Connect J23 Therapy Ribbon

cable (W11)

1

Connect P2 System/ Interface

Flex (W04)




13. Reassembling the Case (continued)

13.6 Install 14 new screws (201407-069), torque to 10.0 in-lb using a P2 bit.

13.7 Reinstall the right corner bumper (3207307-001) with 4 screws (3207361-375), torque to 10.0 in-lb using Torx T-15 bit.

13.8 Reinstall the left corner bumper (3206968-000) with 4 screws (3207361-375), torque to 10.0 in-lb using Torx T-15 bit.

NOTE: If new bumpers and feet are required, use Guard & Feet Repair Kit (MIN 3305431-019).

Screws 201407-069 (14 places)


Screws 3207361-375

(8 places)




14. Installing the Label Set

14.1 Use a new parameter bezel label. Apply the parameter bezel label (#1) from the label set (3207318-XXX or 3305642-XXX) to the bezel front. Press the label down firmly.

14.2 If present, install the CO2 cover (3207407-000) onto the CO2 adapter.

CO2 Connector

Cover 3012120




15. Post-Installation Activities

15.1 Load current release of LIFEPAK 15 software

15.1.1 Press the ON key. Verify which version on Main system software is displayed on startup screen of device.

3207410 = Version 1 (V1) LIFEPAK 15

3306808 = Version 2 (V2) LIFEPAK 15

Note: Do not install V1 LIFEPAK 15 software on a device that already has V2 software installed.

15.1.2 Install device software that is specified on the Unit Barcode Traveler (UBT) or kit packing list. (See V2 software information in previous step). Follow combined loader instruction 3206073.N or greater, and perform sections 9, 10 and 11. For section 11, select menu options Modules, and then select software dash number. For example, device software 3308045-005 listed on the

upgrade UBT or packing list would match Modules- software dash number of 005.

15.2 Using combined loader instruction 3206073.N or greater section 12, press the CONFIGURE button.

Select SpO2 pull-down and select B= ON – Masimo SpO2. Press OK at the bottom of the screen.

15.3 A requirement for LIFEPAK 15 version 2 devices is to have Voice Recorder set to B=ON.

Using section 12, press the Configure button. Verify Voice Recorder pull-down is selected B=ON. Update if not set to B=ON. Press OK at the bottom of the window.

15.4 Perform PIP/TCP

15.4.1 Complete Performance Inspection Procedure (PIP) for a LIFEPAK 15 device for all the features that are installed into the device. Use LIFEPAK 15 V1/V2 Service Manual, Manual PIP/TCP procedure or CAPIP test.

16. Document the Upgrade (International Service – document service action per local processes)

Complete a standard upgrade service report to document all upgrade activities. Perform Post Service Report download.

lifepak 15 monitor defibrillator spo2 upgrade · title lifepak 15 monitor defibrillator spo2...

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