Document Detail - Stryker Corporation · Title Technical Bulletin_Service Data Management Tools...

PHYSIO-CONTROL

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Type: BUSINESS DOCUMENT

PC000211[C]Document No.:

Technical Bulletin_Service Data Management ToolsTitle:

HUBERD2 DAVID HUBEROwner/Modifier:

CURRENTStatus:

Effective Date: 05-Jul-2019View Expiration Date:03-Jul-2017

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StatusFixed RevRelationDocument No. Content Type

EXPIREDMaster Document No7000180 [Q] DOCUMENT

Title:SERVICING PROCESS WORK INSTRUCTION

CURRENTRelated No3012679 [N] DOCUMENT

Title:USERS GUIDE - CODE-STAT

EXPIREDRelated NoPC000338 [L] DOCUMENT

Title:Aftermarket Service Depot Documentation List

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Build No.: 4 Closed Date: 6/8/2017 7:54:12AM

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HUBERD2HUBERD2 DAVID HUBERSUBJECT MATTER EXPERT-CAPA

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BELLC1BELLC1 Casey BellTRAINING PROCESS OWNER

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1 08-Jun-2017 7:54 am

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Title Technical Bulletin_Service Data Management Tools Page Page 1 of 31

Doc Type BUSINESS DOCUMENT Doc Owner HUBERD2 Doc ID PC000211

Doc State CURRENT Effective Date 7/3/2017 Doc Rev C

QS Parent Servicing Process Work Instruction, 7000180

Template 7000502 Revision B

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 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.

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Change Description

Updated Technical Bulletin_Service Data Management Tools to revision C. Replaced references to Medtronic with Physio-Control throughout the document. Updated document to optimize Technical Bulletin format Revised Section 2. As Scope. Revised Section 3. Overview. Replaced multiple images to align with current software versions for Code Stat 9.0 and DT Express. See redlines for detailed changes. Read and Understand training was removed at revision C for TR_Aftermarket Operations, TR_Failure Analysis Technician, TR_Technical Support, TR_Non-US Service Technical Process, TR_Service Engineer, and TR_Service Field Admin. Read and Understand training was added at revision C for TR_Non-US Field Service Rep. Read and Understand training is required for all other roles assigned to this document.






TECHNICAL BULLETIN

Bulletin Name: Technical Bulletin_Service Data Management Tools

Applies to:

☒ Field Service

☒ Depot

☒ Technical Support

☒ Americas

☒ APAC

☒ EMEA

☒ Global (All the above)

Product Family: CODE-STAT Reviewer Version: 9.0

Subject: Service Data Management Tools

1. PURPOSE

This Business Process provides the Service Representative with a process review to set-up and use Data management tools used for daily service activities.

2. SCOPE

This Business Process applies to Service Representatives with a process review to set-up and use Data management tools used for daily service activities only.

3. OVERVIEW

CODE-STAT AND DTX CODE-STAT Initial Set-Up (and recommended settings)

Create a database

Configure communication ports

Perform the initial configuration of the database

Create a user account on the database

Create an exporter

4. CODE-STAT INITIAL SET-UP (AND RECOMMENDED SETTINGS)

4.1 In Code-Stat, Create a new database:

Open Database Utilities. (Start, All Programs, Physio Control, Administrative Tools, Database Utilities…)






Select Create New Database icon.

Select Demo* to use as the template,






Give it a name and browse it to the default (C:\Program Data\Physio-Control\Databases) folder on your C: drive.

Click OK to close the “Browse for Folder” window.

Check the box “use as the default db”. (See note below.)

* Note: We use demo as the template so that our new db will contain all the same user ID’s and other config options as the demo db. If you use blank, none of the configurations will apply to the new db.

4.2 Click Create. After successfully creating the new database, click OK, then close the Database Utilities window.

4.3 Configure Communication Ports:

Launch the Device Communications application. (Start, All Programs, Physio-Control, LIFENET Device Communications…)

Click Control, System Configuration...

Select Device Data Reception tab.






Select Modify and select most com ports which appear in the available box. Specifically, ensure that the following are chosen: “COM1 Direct”, “Infrared IFYS-8003 IrDA FIR USB Adapter” *

Note: * Use of equivalent parts is permitted per Service Support Document Development Work Instruction,

7000742.

Use the arrows to move them into the Use box so that they will be available for use by the CS (and DTx) application.






Then click OK. Note: Be aware that more than 5-6 com ports in the Use box can have the result that not all will be recognized as being available for use. If so, remove some from the Use box.

Deselect the option that synchronizes the device clock with the computer clock.

Select the Device Data Destination tab and verify that the new database you created is defaulted. Click

OK.

You will receive a message stating that the configuration has changed. Click OK and then restart the

program by selecting Control, LIFENET Communications Disable, then followed by Control, LIFENET Communications Enable.






The Dev Comm program should now be ready to retrieve data from all Physio-Control devices and store it to your db. Click the red X to close the program and then click OK to allow the program to run in the background.

* Note: When downloading customer data, we don’t want to synchronize their device clocks away from their dispatch clocks.

4.4 Code Stat Initial Configuration: How to set up our programs so that the retrieval and analysis of patient data is facilitated

Use Device Times as opposed to System Adjusted Times: (In the reviewer database we want to see the same time of day as the device did.)

Launch Code Stat Reviewer and log in to your newly created database using physio as the user name, and control as the password.






Select File, Administration, and select the View tab.

Under Initial Time Adjustment setting, choose Device Times.

Set Report Frequency Response Filter to use the same filter as the device default for CODE-SUMMARY Reports.






4.5 Create a user account on the database

While in the Administration window, it would be a good time to set up our new database with our own unique user name and password, so that we don’t have to use the default password.*

Select the User tab and click ADD.

Type in the following:

o Your name. o Your screen name. o Your password twice. o Make yourself an administrator on the system.

* Note: Don’t get into the habit of sharing the physio – control log in account with your customers. Encourage them to create their own unique accounts in Code Stat. We don’t want unauthorized users logging into patient databases.

4.6 Configure an Exporter: In the event we encounter a reportable incident, we will be able to download the patient record and easily export the file to our Regulatory Specialist via e-mail.

From the CS Reviewer application, select File, Export, Export Setup.






Click New and choose LIFENET Data Management System as the export module.

Name the exporter “e-mail to Physio-Control Post Market Surveillance”

Select via e-mail and type in [email protected] and Click Check Names.

5. DOWNLOAD-TO- DTX WITH EVENT CHECK

5.1 General Information

o Configure Data Transfer Express o Download record o View Test Log o Export report to folder and copy file to CD o Print record

5.2 Launch DTx via the Start menu, or by using the desktop shortcut icon






5.3 How to set up the basic Configuration Properties for your DTx program: (Select File, then Configuration to open):






Set Site ID (General Tab) to be your rep code

Set Time Adjustment (General Tab) to be Device Time

Set Case List Controls (General Tab) for Advanced

Set Organization Name (Case Reports Tab) to be your rep code

Check Communication Ports to Use (Communication Tab)

Deselect “Automatically synchronize device clock with this system clock” (Communication Tab)

Deselect “Skip Device selection…” (Download Wizard Tab)

Select Default Patient “None” from the drop-down menu (Download Wizard Tab)

Select OK to save changes

Close Configuration Properties window.

6. LAUNCH THE DOWNLOAD WIZARD.






6.1 Select the device type and click Next.






6.2 If you would like to download data from the LIFEPAK 20, LIFEPAK CRPlus, or the LIFEPAK 1000 align the device with your IrDA port and turn on power. If you would like to download data from the LIFEPAK 12, LIFEPAK 15, or the LIFEPAK 500 connect the appropriate cable and turn on the device power.

6.3 Select the Current Patient Complete record and click Next.






6.4 Click Finish to close the download wizard when download is complete.

6.5 View the Test Log

Find the desired record in the case list and select it.

6.6 Click the Print icon

6.7 Select the Test Log Report, then select Microsoft XPS Office Document Writer from the Select Printer drop down menu, then click Print.






6.8 Save the report to your desktop






6.9 Export report to folder and copy to CD

6.10 Open DTx and select File then Configuration

6.11 In Configuration Properties select the Exporters tab then select New

6.12 Select LIFENET Data Management System then OK

6.13 Name the destination “Event Check Folder” and verify that the export method is “via File Drop” and when “Manually Initiated” then select Browse






6.14 Select Libraries/ Documents as a location then select Make New Folder. Event Check Records is a good name for the folder however feel free to name it as you wish

6.15 Select OK then OK again to exit Exporter Configuration

6.16 Find the desired record in the case list and select it






6.17 Select Export and then Finish when the transfer is complete

6.18 Navigate to Libraries/Documents\Event Check

6.19 Records then copy the desired record to the CD provided with Event Check kit

7. PRINT THE PATIENT RECORD

7.1 Locate the desired record in the Case List and select Print Reports






7.2 Select Case Summary, Event Log, and Continuous ECG / Complete along with the desired printer or select Microsoft Document Writer to create an electronic copy *

* Note: If you select Microsoft Image Writer the application will create three separate documents for the files selected to include the Case Summary, the Event Log, and the Continuous ECG which will each print to a separate file. Browse to the location where you would like to create the files and then provide a unique name for each file that includes the account name and date. Once complete select all three files right mouse click and select Send to Mail Recipient to email the records to the customer.

8. BLUETOOTH SETUP, LP12 DOWNLOAD CODE-STAT

8.1 How to verify which COM ports are used by Bluetooth

8.2 Navigate to Start/Control Panel/System/Device Manager

8.3 Select Ports (COM & LPT)

8.4 Bluetooth COM port displayed

Bluetooth Download Instructions






8.5 Make a note of the Bluetooth COM port number for use in Device Communications setup. If no COM ports are present contact your TSS.

8.6 Enable the correct COM Ports in Device Communications

Start LIFENET Device Communications Status one of two ways:

If the LIFENET Device Communications Status Icon is on the Desktop, double-click it.

—or— Select START | PROGRAMS | PHYSIO-CONTROL | LIFENET DEVICE COMUNICATION






Note: If the Bluetooth COM port is already present skip to section 8.8, otherwise continue with the next step.

8.7 From the LIFENET Device Communications menu bar select: Control | System Configuration

Next, click on the Device Data Reception Tab






Click on the Modify button

Recall from Step 8.5 which COM port is used by Bluetooth. Move the desired Bluetooth COM Port (in this case COM 4) from the Available (left) side over to the Use (right) side via the move arrows >>.

Click OK, then OK.






8.8 If you change the settings in the System Configuration, the following message will appear:

From the menu bar select Control | LIFENET Communications | Disable to release the previous settings, then choose Control | LIFENET Communications | Enable to enable the new COM settings.

8.9 The window can then be closed, with Device Communications continuing to run in the background.

Note: The LIFENET Communications can also be disabled prior to opening System Configuration.

However, please remember to complete this task by re-enabling them.






8.10 Perform the Data Downloads

Launch Device Communications on the destination PC if it is not already running.

Start LIFENET Device Communications Status one of two ways:

If the Device Communications Status Icon is on the Desktop, double-click it. —or—

Select START | PROGRAMS | PHYSIO-CONTROL | LIFENET DEVICE COMUNICATIONS

8.11 To ‘Hot Dial’ a new site from the LP12:

Note: One temporary transmission site is available for you to set up ‘on the fly’. You can use it repeatedly to send to different destinations.

The advantage to ‘Hot Dialing’ is that the transmit site created is deleted when power is turned off. This allows us to test the transmit function without changing the customers device setup.

Press the TRANSMIT button. On the Transmit screen, choose DATA.

Select SITE, then NEW SITE






Enter the site information as follows.

NAME - Enter a temporary site. Can be one letter such as Z.

PORT - ‘DIRECT CONNECT’ LP12 connection directly to LIFENET Device Communications is always Direct.

WIRELESS – ON Bluetooth by definition is Wireless

Press MORE.

Note: For direct connections a Phone # and Prefix are not required.

Z Direct Connect

ON

New Site






Press DONE.

Select the Report that you wish to send, Code Summary makes a good test.

Press SEND. If only one trusted device is available to receive the data, transmission begins.

Otherwise, wait, be patient ….it takes a few seconds and nothing appears to be happening. You should see a ‘Connecting’ appear at the bottom of the screen.

The LP12 will then search for discoverable wireless devices.

Within a few seconds, choose one of the sites. (It will time-out if you don’t respond quickly.)

Z






Select the device you want to pair with and add it as a trusted device.

Make note of the Passcode as it is required later in this process.

Direct your attention to the computer and you should see the following message.

Click directly on this message window. (It will time out if you wait too long.)

At this point, enter the pass code given on the LP12 (“6780” in this example).

Cancel

Send






After successfully pairing you will see the following window.

Pay special attention to the Windows default that turns discovery off.

If at any point the pairing process times out, you’ll receive a message stating “Error Pairing this device” on the LP12.






APPENDIX

For data download via Bluetooth wireless connection: Refer to Document.

# 3203546-000 (LIFENET BLUE Wireless Data Transfer Reference Guide) and Document.

# 3203782-000 (LIFENET BLUE Wireless Data Transfer Quick Reference Card).

Sometimes it will be useful to “Remove All” previously paired devices from the LP12 setup. (When is it useful? When you may have been doing repeated transmissions with several different PCs OR when the devices appear to be connecting, but transmissions are not successfully completing.) Please be aware that if you remove all paired devices that you will then have to restore all pairs for the customer. a. Enter Setup mode on the LP12. b. Choose TRANSMISSION / DATA / WIRELESS / REMOVE ALL. c. Select YES to ‘Remove all trusted devices?’

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