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PHYSIO-CONTROL

11811 WILLOWS ROAD NE - POST OFFICE BOX 97006

REDMOND

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10/5/2019

1

Document Detail

Type: SUPPORT DOCUMENT

SD000034[A]Document No.:

DEVICE COMPLIANCE TOOL BUSINESS PROCESSTitle:

HUBERD2 DAVID HUBEROwner/Modifier:

CURRENTStatus:

Effective Date: 05-Oct-2021View Expiration Date:05-Oct-2019

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Revision Notes

1 Check In 09-Aug-2019HUBERD2

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2 Check In 04-Sep-2019HOWEA1

Note: fix formatting, typos


Note: fix formatting


Note: fix formatting


Note: fix page breaks

10/5/2019

2

Document Detail

Review

DOCUMENT APPROVAL (NO TRAINING PERIOD)

Review Purpose: Initial document approval. No collaboration required.

Review:

Build No.: 1 Closed Date: 9/10/2019 9:33:39PM

Review Note: SYSTEM AUTO CLOSE REVIEW

Sign-off ByActorOwner RoleLevel Sign-off Date

HOWEA1HOWEA1 Andrea HoweDOCUMENT CONTROL

DOCUMENT CONTROL

0 04-Sep-2019 11:59 pm

Note To Approver:

Note From Approver:Quality check complete

HUBERD2HUBERD2 DAVID HUBERDOCUMENT OWNER DOCUMENT

OWNER

1 05-Sep-2019 1:53 pm

Note To Approver: signing as Doc Owner and SME

Note From Approver:Approved

SALAZJ1SALAZJ1 Juan SalazarQS PROCESS OWNER QS

PROCESS OWNER

1 06-Sep-2019 3:09 pm

Note To Approver:

Note From Approver:Approved

KDASHENKDASHEN Kim DashenQUALITY SYSTEM TEAM

MEMBER QUALITY SYSTEM

TEAM MEMBER

1 10-Sep-2019 9:33 pm

Note To Approver:

Note From Approver:This is approved.

BELLC1BELLC1 Casey BellTRAINING PROCESS OWNER

TRAINING PROCESS OWNER

1 05-Sep-2019 9:02 am

Note To Approver:

Note From Approver:Approved.

Title DEVICE COMPLIANCE TOOL BUSINESS PROCESS Page Page 1 of 51

Doc Type SUPPORT DOCUMENT Process Owner SALAZJ1 Doc # SD000034

Doc State CURRENT Effective Date 10/5/2019 Doc Rev A

QS System Service Provision QS Process Field Service Depot Aftermarket

QS Parent 7000180, Servicing Process Work Instruction

Confidential – Stryker Proprietary Information – Do Not Duplicate

This document is guidance only. It does not specify any Quality System requirements.

This document is electronically signed. Approvals can be obtained from the system which displays the selected approvers, their approval roles, and approval dates.

PROPRIETARY AND CONFIDENTIAL DOCUMENT FOR STRYKER MEDICAL REDMOND USE ONLY. This document is property of Stryker Medical Redmond and may not be used, reproduced, published or disclosed to others without authorization from Stryker Medical Redmond.

Change Description

This document is revised from PC000220 to put in the correct document type per 7000167. Changed from PC000220 Rev D include: Updated Scope to correct section number reference.

Updated section 4 to add catalog numbers and new IrDA adapters.

Updated section 5 and 6 for 1.5 release of DCT.

Added instructions in section 5.13 to manually upload session files.

Added instructions in section 5.4 to create a password to use with DCT.

Added instructions in section 6.1 to maintain DCT keyfile.

Added Appendix A Understanding DCT Leases.

Effective upon release.

Read and understand training required for TR_Service Technical bulletin and TR_Non-US Field Service Rep.








PURPOSE

This Business Process provides instructions on the use and capabilities of the Device Compliance Tool Software Release, 3332885 application for Technical Service Representatives use when servicing Physio-Control devices.

SCOPE

This application will be used on all LIFEPAK 12, LIFEPAK 15, LIFEPAK 500, LIFEPAK CR Plus, LIFEPAK Express, LIFEPAK 1000, LIFEPAK CR2, and LIFEPAK 20/20e devices that are under the control of the Service Organization. Accessories for these devices are out of scope for this application.

This Business Process provides detailed instructions on how to use the Device Compliance Tool (DCT) application. The DCT application is equipped with the two operating modes; SFDC Mode for US and Local Mode for OUS use. The SFDC Mode will compare the configuration stored in Salesforce.com (SFDC) against the configuration settings in the device under test, display error codes from a device, compare software sets, launch the CAPIP application, and transmit data to the Salesforce.com work order and the Data Warehouse. Local Mode is able to perform all of the functions of SFDC Mode minus the ability to download the device configuration from ServiceMax and transmit the data to the work order.

DCT SFDC Instructions – Section 5 (US TSR)

DCT Local Mode Instructions – Section 6 (OUS TSR)

DEFINITIONS AND ACRONYMS

3.1 DCT – Device Compliance Tool

3.2 Session – DCT activity performed on a device

3.3 TSR – Technical Service Representative

3.4 CAPIP – Computer assisted performance inspection procedure

3.5 PIP – Performance inspection procedure

3.6 SFDC – Salesforce.com, A cloud-based software as a solution application which will be used as the main tool for recording, tracking and logging service-related transactions

3.7 ServiceMax – A cloud-based software application used within Salesforce.com to document service and complaint activity

EQUIPMENT

DCT is configured to use the following cables and adapters for device download.

Device Cable/Adapter Part Number Description

LP1000, LPCR 21300-005026 ADPTR-IRDA,EXT,USB,IFSYS-8003A

LP1000, LPCR ACT-IR4000US Infrared interface finger-size USB adapter

LP12, LP15 11996-000369 ROHS LP12-LP15 TO PC USBCABLE,RETAIL PACKAGED

LP500 11996-000286 ROHS LP500 TO PC USB CABLE,RETAIL PACKAGED

LP20 U209-000-R Tripp Lite USB to Serial Adapter

LP20 11230-000018 LP20 Data Transfer Cable (serial)








DCT SFDC MODE (US TSR)

5.1 Overview

DCT SFDC Mode is used primarily by US service representatives that document their service activity in ServiceMax.

5.1.1 The DCT application will allow the service representative to perform device downloads, read error codes, compare software sets, user settings, and configuration settings, verify manual PIP completion, and launch the CAPIP application.

5.1.2 The DCT user interface will be comprised of four major sections:

Install Base Config

User Settings

Service Messages

CAPIP

5.1.3 When the DCT application is used it creates a session that is assigned to the device. When a session is complete and work is finished on a device, DCT will transmit and close the session.

5.1.4 Once a DCT session is completed it cannot be re-opened. A new session will have to be created for any future activity on a device.

5.1.5 If the TSR starts a session and decides to finish it at a later time, DCT will save all data from the session when closed and allow the user to start the application again. When DCT is restarted, the unfinished session can be searched for and retrieved with the saved data.

5.1.6 The TSR will start a session by searching for a serial number of a device. DCT will download the configuration settings of the device from SFDC. In the event that DCT does not have an internet connection, the device configuration will not be downloaded but the user can still perform downloads and CAPIP. The session can be completed when internet connection is once again established.

5.1.7 Once the device is selected the TSR can choose the work order that is assigned to the session. Every session must have a work order assigned to complete the session. The work order can be changed or added at any time during the session before it is finalized.

5.1.8 DCT will allow the TSR to perform pre and post downloads of the device. Only one pre-download can be performed. There is no limit on the amount of post downloads that can be performed until the session is finalized. Once the session is finalized pre and post downloads cannot be performed unless a new DCT session is created.

5.1.9 Each section will have an overall status of Red (fail) or Green (pass) that is indicated by a light on the right-hand side of each section.








5.1.10 Mismatches that are found in a section are indicated in Red.

5.1.11 When all sections of DCT have a green state, the Finalize button becomes active








5.1.12 Each section will have the ability to be overridden from a Red to Green status if the repair is not going to be completed or if the section error cannot be resolved by the repair activity. To override a section, enter a comment and click the Override button.

5.1.13 When the session is finalized, the session data is sent to both the work order assigned and the data warehouse. DCT will also check the DCT Complete box on the work order allowing the user to close the work order in SFDC.

5.2 OFFLINE

5.2.1 It is recommended to use DCT while connected to the internet. A DCT session cannot be completed without internet connectivity. Internet connectivity is required to verify log-in credentials, download configuration data, search for open work orders, and to transmit the session data. If for any reason you need to use DCT when internet connectivity is unavailable, DCT will allow the user to work in offline mode.

5.2.2 DCT will allow the TSR to perform pre and post downloads, view download configuration, view error codes, and user settings, verify correct software sets, run CAPIP, and check for manual PIP completion in offline mode.

5.2.3 DCT will not be able to download the device configuration or search for open work orders from SFDC when in offline mode. It is possible for the TSR to download the configuration data and assign the work order while online, save the session, and continue the session while in offline mode. The TSR will need to connect to the internet eventually to finalize the session. If the TSR in unable to download the device








configuration prior starting a new session, DCT will allow the user to manually enter the device ABBA code for comparison to the device downloads.








5.2.4 While working in offline mode, the TSR will have the ability to re-connect to the internet when available by clicking the Try Connect button.

5.3 UPGRADES

5.3.1 DCT does not have the ability to verify the upgrade configuration based on the part that is installed on the work order.

5.3.2 When performing feature upgrade on a LIFEPAK 12 and LIFEPAK 15 device the post-download will not match the downloaded configuration from SFDC. DCT has an upgrade function to document the type of upgrade being performed to allow DCT to clear the Install Base mismatch error.








5.4 LOGIN

5.4.1 The DCT application can be started by going to Start/Device Compliance Tool x.x./Device Compliance Tool

5.4.2 The first time DCT is launched you will be required to enter your SFDC user name and password. The security token is not required if you are using the Murdock version of ServiceMax

5.4.3 The Murdock version of ServiceMax uses a windows single sign on for log in access. You will need to create a password in ServiceMax for the purpose of DCT log in.

5.4.3.1 In ServiceMax select My Settings








5.4.3.2 Click the Change My Password link








5.4.3.3 Create a new password to use for DCT login

5.4.4 After initial log in, DCT will store your log in credentials for ease of use.








5.4.5 If you launch the DCT application with no internet connection an error message will appear asking if you would like to work in offline mode. The same message is also displayed if you enter your password, user name, or security token incorrectly.

5.4.6 After successful log in, the Select Device screen will be displayed.

5.4.7 The Select Device screen is used to search for the device being serviced.

5.4.8 You must select the Product Family of the device using the drop down menu.

5.4.9 After selecting the Product Family, you can scan or enter the serial number of the device.

5.4.10 Session Hints allows the TSR to display any unfinished devices in DCT.

5.4.11 After searching for the device, the Select Work Orders screen is displayed.

5.4.12 You can now select the work order(s) that you want assigned to the session.








5.4.13 After selecting the work order, the configuration data is loaded into the Install Base Config section and the device and work order information is displayed on the left side of the screen.








5.5 DOWNLOADS

The DCT application can download data from the LIFEPAK devices and transmit the information to the work order and the data warehouse. The application uses the Pre-Download and Post-Download buttons to capture this information.

5.5.1 If the device is not able to have a download performed (won’t turn on), a Compromised Pre-Download button can be used to document the event. Once the device is repaired to a state that will allow a download, you can proceed with the Pre-Download

5.5.2 Connect the device to the computer or align the IrDA adapter to start the Pre-Download.

5.5.3 Power on the device and click the Pre-Download button after the device boots up.








5.5.4 After the download is complete the Pre-Download data is added to the Install Base Config, User Settings, and Service Messages sections.

5.5.5 The DCT application will alert you if a mismatch is found in the Install Base Config section or if any error codes are present.








5.5.6 After a Pre-Download is completed a Post-Download can be done.








5.5.7 The Post-Download data is added to the Install Base Config, User Settings, and Service Messages sections

5.5.8 The DCT application will alert you if a mismatch is found in the Install Base Config, User Settings section or if any error codes are present.

5.5.9 The Post-Download can be performed multiple times as needed during the session








5.5.10 The Reset button can be used to restart the application if a device download fails.

5.6 INSTALL BASE CONFIG SECTION

5.6.1 After successfully completing a pre download, the device configuration is loaded into the Install Base Config section and is compared to the device configuration from SFDC. Any mismatches between the Install Base and the Pre-Download will be highlighted in Red.

5.6.2 After post-download is completed, the device configuration is loaded into the Post-Download section of the Install Base Config section. Any mismatches between the Installed Base and Post-Download will be highlighted in Red.

5.6.3 A configuration mismatch between the Post Download and Installed Base will cause the Install Base Config section to have an overall status of Red. You can override any errors in the section by entering a comment and clicking the Override All Errors button.








5.6.4 If you start a DCT session while offline and are missing the installed base configuration, the user can click the Enter button to manually enter the ABBA code for the device. This will allow DCT to compare the device downloads to the Installed Base ABBA code while offline.

5.6.5 The Update button is used to replace the manually entered ABBA code with the ABBA code stored in SFDC when DCT is connected back online. Adding a work order to DCT when back online will perform the same function.

5.6.6 The Upgrades button is used to clear a post-download error when a feature upgrade is performed on a device.








5.6.7 Click the upgrade box you are performing and click the Apply button to clear the configuration mismatch error that is caused by a feature upgrade.








5.7 USER SETTINGS SECTION

5.7.1 The user settings data is loaded into this section when a pre and post download is completed.

5.7.2 Any mismatch between a pre and a post download will be highlighted in Red.

5.7.3 The “Settings Verified with Customer” check box is used to document a user settings change with the customer.

5.7.4 A mismatch of user settings between the pre and the post download will cause the User Settings section to have an overall status of Red. You can override any errors in this section by entering a comment and clicking the Override button.








5.8 SERVICE MESSAGES SECTION

5.8.1 Device error codes from the pre and post downloads will be displayed in the Service Messages section.

5.8.2 Software set checks for the LIFEPAK 20 and LIFEPAK 15 devices will be performed in this section. A bad software set will be highlighted in Red.

5.8.3 The Info button can be used to provide additional information on the software set.

5.8.4 A bad software set and/or an error code in the post download section of Service Messages will cause this section to have an overall status of Red. You can override any errors in this section by entering a comment and clicking the Override button.

5.9 CAPIP SECTION

5.9.1 The CAPIP section will allow the user to launch the CAPIP application. The Launch CAPIP button is enabled after all CAPIP questions are answered.

5.9.2 The CAPIP section will also check the counters on devices that don’t use CAPIP to verify that a manual PIP was completed.

5.9.3 If CAPIP is not completed with a passed result or if the device downloads indicate that a manual PIP was not completed, the CAPIP section will have an overall status of Red. You can override any errors in this section by entering a comment and clicking the Override button.

5.10 CHANGE DEVICE OR WORK ORDER

5.10.1 DCT has a section on the top left that will allow the TSR to add or change work orders or change a device to start a new session.

5.10.2 DCT will allow you to remove and add work orders assigned to a session at any time until the session is finalized

5.10.3 You can change a device before you are finished with a session. DCT will save where you have left off and give you the option to search for an unfinished session to complete at a later time.








5.10.4 Click on the Change Work Orders or Change Device buttons to bring up the search menu to make the change when needed.

5.11 OVERRIDE

5.11.1 The Install Base Config, Service Messages, User Settings, and CAPIP sections all have the capability to be overridden to change the overall status from Red to Green if the error cannot be cleared by performing another post download.

5.11.2 To override a section, you must enter text explaining why the error cannot be cleared. After entering the text in the comment box, click the Override button to change the section from Red to Green.

5.11.3 If you perform a post download after overriding a section, the override will be cleared, and you must click the override button again if necessary.

5.12 FINALIZE

5.12.1 When a DCT session is complete the TSR must click the Finalize button to transmit the data to SFDC and the data warehouse.

5.12.2 The Finalize function will only work if the Install Base Config, Service Messages, User Settings, and CAPIP sections are all Green.

5.12.3 You must have an Internet connection in order for the Finalize function to work.








5.12.4 If for any reason you cannot finalize, DCT will save your work and allow you to complete finalization at a later time.

5.13 Manually Attaching DCT Files

If you come across a situation where the DCT application is not automatically attaching the session file to the work order you will need to manually attach the session file. Follow the procedure found in section 6.13 to manually attach the session file if the DCT application is not currently working.

5.14 ONLINE PROCEDURE

The following is a procedure a TSR would perform while online, repairing a device, and performing CAPIP inspection.

5.14.1 Launch the DCT application.

5.14.2 Enter your SFDC user name and password if required.

5.14.3 Select the product family of the device you are working on, enter the serial number, and click the search button.

5.14.4 Click Yes to start a new DCT session.

5.14.5 Select the work order(s) you would like to use for this session and click Ok.

5.14.6 Perform a pre-download on the device by clicking the Pre-Download button.

5.14.7 Open the Install Base Config section and check for any configuration mismatches.

5.14.8 Open the Service Messages section and check for any error codes or software set errors.

5.14.9 Repair device

5.14.10 Perform a post-download by clicking the Post-Download button.










5.14.13 Open the User Settings section and check for any mismatches.

5.14.14 Open the CAPIP section, answer all the configuration questions and launch the CAPIP test.

5.14.15 Complete all CAPIP tests with a passed result.




5.14.19 Verify that that Install Base Config, Service Messages, User Settings, and CAPIP sections have an overall status of Green.

5.14.20 Click the Finalize button and click Yes to confirm.








5.15 OFFLINE PROCEDURE

The following procedure is used when the TSR is servicing a device without internet connectivity. DCT will allow the user to perform downloads and CAPIP while offline, but finalization cannot be completed until the computer is online and connected to internet. DCT will allow the user to save the work done offline and allow the session to be opened up at a later time to be completed when online.


5.15.2 Enter your ServiceMax user name and password if required.

5.15.3 DCT will recognize that the computer is not connected to the internet and ask the user to work Offline.

5.15.4 Click Yes to work in Offline mode.



5.15.7 Open the Install Base Config section

5.15.8 Click Enter in the Manual Entry Mode box to manually enter the device ABBA code.

5.15.9 After entering the ABBA code click Ok to load the data into the Installed Base section.









5.15.18 Open the CAPIP section answer the configuration questions and launch the CAPIP test.





5.15.23 Close the DCT application to save your work.

5.15.24 When back in the shop or at a location that has internet access, launch the DCT application.

5.15.25 Enter your ServiceMax user name, password, and security token if required.

5.15.26 Select the product family and search for the serial number of the device worked on during offline mode.

5.15.27 Click the Click to Change Work Orders button to add a work order(s) to the session.









5.15.29 Verify that Install Base Config, Service Messages, User Settings, and CAPIP sections have an overall status of Green.


5.16 UPGRADE PROCEDURE

The following procedure is used when the TSR is performing a feature upgrade on a LIFEPAK 12 or LIFEPAK 15 device. When a feature upgrade is performed, the configuration of the device is changed and will not match the Installed Base configuration in DCT. The upgrade feature in DCT will allow the user to clear the mismatch until the Installed Base can be updated with the new configuration in SFDC.


5.16.2 Enter your SFDC user name, password, and security token if required.



5.16.5 Select the work order(s) you would like to use for this session and click Ok.




5.16.9 Perform feature upgrade on device.


5.16.11 Open the Install Base Config section and click the Upgrade button.

5.16.12 Select the upgrade you are performing and click the Apply button.



5.16.15 Open the CAPIP section answer all the configuration questions and launch the CAPIP test.
















DCT LOCAL MODE (OUS TSR)

6.1 Login Access

DCT Local Mode uses a key file that is stored on the service representative’s computer to control log in access. This key file requires an update at least every two weeks via connection to the Physio Control server. If having trouble logging into the DCT application, make sure you are connected to the internet when launching DCT. This will enable DCT to connect to the Physio Control service and download the latest version of the key file. If this does not correct the log in issue send an email to [email protected] with your computer name to request log in access to DCT Local Mode.

The DCT application uses a login keyfile to verify access. The login keyfile must be updated weekly to maintain your login access. The DCT application refreshes the login keyfile each time it is launched while connected to the internet. If you haven’t used the DCT application in over a week, make sure you are connected to the internet when you launch the application to allow it to refresh the keylog file and verify your login access.

6.2 Overview

DCT Local Mode is used by service representatives that do not have access to ServiceMax.

6.2.1 The DCT application will allow the service representative to perform device downloads, read error codes, compare software sets, user settings, and configuration settings, verify manual PIP completion, and launch the CAPIP application.

6.2.2 The DCT user interface will be comprised of four major sections:

Install Base Config

User Settings

Service Messages

CAPIP

6.2.3 When the DCT application is used it creates a session that is assigned to the device. When a session is complete and work is finished on a device, DCT will transmit and close the session.

6.2.4 Once a DCT session is completed it cannot be re-opened. A new session will have to be created for any future activity on a device.

6.2.5 If the TSR starts a session and decides to finish it at a later time, DCT will save all data from the session when closed and allow the user to start the application again. When DCT is restarted, the unfinished session can be searched for and retrieved with the saved data.

6.2.6 The TSR can restart a session by entering the serial number of the device.

6.2.7 DCT will allow the TSR to perform pre and post downloads of the device. Only one pre-download can be performed. There is no limit on the amount of post downloads that can be performed until the session is finalized. Once the session is finalized pre and post downloads cannot be performed unless a new DCT session is created.

mailto:[email protected]








6.2.8 Each section will have an overall status of Red (fail) or Green (pass) that is indicated by a light on the right-hand side of each section.

6.2.9 Mismatches that are found in a section are indicated in Red.








6.2.10 When all sections of DCT have a green state, the Finalize button becomes active

6.2.11 Each section will have the ability to be overridden from a Red to Green status if the repair is not going to be completed or if the section error cannot be resolved by the repair activity. To override a section, enter a comment and click the Override button.








6.2.12 When the session is finalized, the session data is sent to both the work order assigned and the data warehouse. DCT will also check the DCT Complete box on the work order allowing the user to close the work order in SFDC.

6.3 UPGRADES

6.3.1 When performing feature upgrade on a LIFEPAK 12 and LIFEPAK 15 device the post-download will not match the pre-download. DCT has an upgrade function to document the type of upgrade being performed to allow DCT to clear the Install Base mismatch error.








6.4 LOGIN

6.4.1 The DCT application can be started by going to Start/Device Compliance Tool x.x./Device Compliance Tool

6.4.2 Enter your windows user name to log into DCT








6.4.3 After successful log in, the Select Device screen will be displayed.

6.4.4 The Select Device screen is used to enter the serial number of the device you are working on.

6.4.5 You must select the Product Family of the device using the drop down menu.

6.4.6 After selecting the Product Family, you can scan or enter the serial number of the device.

6.4.7 Session Hints allows the TSR to display any unfinished devices in DCT.

6.4.8 After searching for the device the Select Device screen is displayed.

6.4.9 A session work order is automatically created by DCT.








6.4.10 Clicking the OK button in the Select Device screen will bring you to the main section of the application that will allow you to perform your downloads.








6.5 Downloads

The DCT application can download data from the LIFEPAK devices and transmit the information to the work order and the data warehouse. The application uses the Pre-Download and Post-Download buttons to capture this information.

6.5.1 If the device is not able to have a download performed (won’t turn on), a Compromised Pre-Download button can be used to document the event. Once the device is repaired to a state that will allow a download, you can proceed with the Pre-Download

6.5.2 Connect the device to the computer or align the IrDA adapter to start the Pre-Download.

6.5.3 Power on the device and click the Pre-Download button after the device boots up.








6.5.4 After the download is complete the Pre-Download data is added to the Install Base Config, User Settings, and Service Messages sections.








6.5.5 The DCT application will alert you if a mismatch is found in the Install Base Config section or if any error codes are present.

6.5.6 After a Pre-Download is completed a Post-Download can be done.








6.5.1 The Post-Download data is added to the Install Base Config, User Settings, and Service Messages sections

6.5.1 The DCT application will alert you if a mismatch is found in the Install Base Config, User Settings section or if any error codes are present.

6.5.2 The Post-Download can be performed multiple times as needed during the session








6.5.3 The Reset button can be used to restart the application if a device download fails.

6.6 Install Base Config Section

6.6.1 After successfully completing a Pre-Download, the device configuration is loaded into the Install Base Config section of the application.

6.6.2 After post-download is completed, the device configuration is loaded into the Post-Download section of the Install Base Config section. Any mismatches between the Pre-download and Post-Download will be highlighted in Red.

6.6.3 A configuration mismatch between the Pre-Download and Post Download will cause the Install Base Config section to have an overall status of Red. You can override any errors in the section by entering a comment and clicking the Override All Errors button.

6.6.4 The Upgrades button is used to clear a Post-Download error when a feature upgrade is performed on a device.








6.6.5 Click the upgrade box you are performing and click the Apply button to clear the configuration mismatch error that is caused by a feature upgrade.

6.7 USER SETTINGS SECTION

6.7.1 The user settings data is loaded into this section when a pre and post download is completed.

6.7.2 Any mismatch between a pre and a post download will be highlighted in Red.

6.7.3 The “Settings Verified with Customer” check box is used to document a user settings change with the customer.








6.7.4 A mismatch of user settings between the pre and the post download will cause the User Settings section to have an overall status of Red. You can override any errors in this section by entering a comment and clicking the Override button.

6.8 SERVICE MESSAGES SECTION

6.8.1 Device error codes from the pre and post downloads will be displayed in the Service Messages section.

6.8.2 Software set checks for the LIFEPAK 20 and LIFEPAK 15 devices will be performed in this section. A bad software set will be highlighted in Red.

6.8.3 The Info button can be used to provide additional information on the software set.

6.8.4 A bad software set and/or an error code in the post download section of Service Messages will cause this section to have an overall status of Red. You can override any errors in this section by entering a comment and clicking the Override button.

6.9 CAPIP SECTION

6.9.1 The CAPIP section will allow the user to launch the CAPIP application. The Launch CAPIP button is enabled after all CAPIP questions are answered.

6.9.2 The CAPIP section will also check the counters on devices that don’t use CAPIP to verify that a manual PIP was completed.








6.9.3 If CAPIP is not completed with a passed result or if the device downloads indicate that a manual PIP was not completed, the CAPIP section will have an overall status of Red. You can override any errors in this section by entering a comment and clicking the Override button.

6.10 CHANGE DEVICE

6.10.1 DCT has a section on the top left that will allow the TSR to change a device to start a new session.

6.10.2 You can change a device before you are finished with a session. DCT will save where you have left off and give you the option to search for an unfinished session to complete at a later time.








6.10.3 Click on the Change Device button to bring up the search menu to make the change when needed.

6.11 OVERRIDE

6.11.1 The Install Base Config, Service Messages, User Settings, and CAPIP sections all have the capability to be overridden to change the overall status from Red to Green if the error cannot be cleared by performing another post download.

6.11.2 To override a section you must enter text explaining why the error cannot be cleared. After entering the text in the comment box, click the Override button to change the section from Red to Green.

6.11.3 If you perform a post download after overriding a section, the override will be cleared and you must click the override button again if necessary.

6.12 FINALIZE

6.12.1 When a DCT session is complete the TSR must click the Finalize button to transmit the data to the data warehouse.

6.12.2 The Finalize function will only work if the Install Base Config, Service Messages, User Settings, and CAPIP sections are all Green.

6.12.3 You must have an Internet connection in order for the Finalize function to work.








6.12.4 If for any reason you cannot finalize, DCT will save your work and allow you to complete finalization at a later time.








6.13 OUTPUT FILES

DCT Local Mode does not have the ability to automatically attach the DCT and CAPIP session files to the work order. The TSR will need to manually attach the files when documenting service activity in Salesforce.com.

6.13.1 Navigate to C:\ProgramData\Stryker Medical\DeviceComplianceTool15\FileDump to view completed DCT session files

6.13.2 Use the attach file function in Salesforce.com to upload the completed DCT and CAPIP session files to the work order when service is complete.








Note: The ProgramData folder is hidden and may require changing your folder setting in Windows File Explorer to view

6.14 ONLINE PROCEDURE

The following is a procedure a TSR would perform while online, repairing a device, and performing CAPIP inspection.


6.14.2 Enter your windows user name to login.

















6.14.12 Open the CAPIP section, answer all the configuration questions and launch the CAPIP test.






6.14.18 Verify that that Install Base Config, Service Messages, User Settings, and CAPIP sections have an overall status of Green.


6.14.20 Upload DCT and CAPIP session files to the work order if using Salesforce.com

6.15 UPGRADE PROCEDURE

The following procedure is used when the TSR is performing a feature upgrade on a LIFEPAK 12 or LIFEPAK 15 device. When a feature upgrade is performed, the configuration of the device is changed and the Post-Download will not match the Pre-Download. The upgrade feature in DCT will allow the user to clear the mismatch allowing the session to be finalized.


6.15.2 Enter your windows user name to login.





6.15.7 Perform feature upgrade on device.






6.15.13 Open the CAPIP section answer all the configuration questions and launch the CAPIP test.
















6.15.22 Upload DCT and CAPIP session files to the work order if using Salesforce.com

APPENDIX A – UNDERSTANDING DCT LEASES

DCT is a secured application. You cannot use it without your machine name being listed in a file stored at Stryker Medical Redmond (SMR). Every 7 days DCT contacts SMR to get the current list of allowed machines (Your machine name will need to be on this list). DCT reads the list and looks for your machine name. If your machine is on the list, you receive a “lease” of 7 days.

You Have to be ONLINE At Least Once a Week

The first time you start DCT, your computer will need to be online (a standard Internet connection). DCT will contact SMR and obtain your lease. You can now use DCT for 7 days on your current lease. DCT will try to update your lease each time you start it, however, if DCT cannot contact SMR via the Internet (you are offline), it will continue to work for the residual of your lease (total of 7 days). If 7 days elapse and DCT has not been able to contact SMR, your lease expires, DCT will deny use. DCT will again need to contact SMR and demands that you be online to make contact.

What Happens If My Lease Is Expired?

If you start DCT and your lease is expired, DCT will automatically try to connect to SMR and get your lease updated. This will be a seamless activity if you have Internet connectivity to SMR. If you don’t have Internet connectivity to SMR then DCT will indicate your problem (see the How DCT Communicates Your Lease Status section)








How DCT Communicates Your Lease Status

At startup, DCT will ask you for your login User Name.

If your login User Name is incorrect, you will see a dialog similar to the following








Your user name must be correct to use DCT (See Appendix A for details on the correct DCT User Name).

Once you enter the correct User Name, DCT will attempt to renew your lease. Whether the lease is updated or not, DCT communicates your current Lease status. When your lease is still active for over 6 days, you will see the dialog below.

If your lease will expire in less than 6 days, you will see a dialog like the following:

This dialog contains a Renew Lease button. Remember, renewing your DCT lease happens automatically if you are online. But if you know that in the next couple of days you will NOT have Internet connectivity (and DCT cannot automatically renew its lease) you can click the Renew Lease button to renew your lease now. This allows you to set yourself up with the maximum lease time when you know you will be in a situation where Internet connectivity will be unknown.








Clicking the Renew Lease button updates your lease to the full 7 days. You will see the dialog below:

If you try to renew your lease and you don’t have internet connectivity, you will see a dialog like the one below:

If at anytime you see the dialog above, DCT is trying to renew its lease and cannot contact SMR via an Internet connection.








Windows Username

To login to DCT use your SMR Windows user name. If you are unsure of what this is, follow these instructions:

Click Start

Type RUN (press Enter)

Type CMD (into the dialog that opened) and click OK

A command window will open. Type “set username” (no quotes) and press enter.

USERNAME=xxxxxxx should show in the CMD window where xxxxxxx is your user name.

xxxxxxx is the user name you log in to DCT with.

Date post:	25-May-2020
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