Date: SAP DIR #: TSB CPWS Installation with Windows 7 32-bit. P/N Description P/N Description PCE-210 PC BASED CPR-UI-UB-D

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Technical Service Bulletin Welch Allyn, Inc. 4341 State Street Road Skaneateles Falls, New York 13153-0220 USA Cardio Products Bulletin Type: As Needed Tel: 1-315-685-4100 Fax: 1-315-685-4653 www.

1 Technical Service Bulletin Welch Allyn, Inc State Street Road Skaneateles Falls, New York USA Cardio Products Bulletin Type: As Needed Tel: Fax: Date: SAP DIR #: Subject: CAR Number: Distribution Scope: TSB CPWS Installation with Windows 7 32-bit WA Internal WA Technical Support, Product Service, & International Service Centers Product(s) Referenced: Cardio Perfect Workstation (CPWS). Refer to the table below: (Product Upgrade, Combination bundles, and Viewing License part numbers not listed.) P/N Description P/N Description CPR-UI-UB-D PCR100 RESTING ECG, CPSP-UN-UC-D-P INTERP, AHA SYSTEM WITH PC ONLY CPR-UN-UB-D CPRL-UN CPR-UN CPR-UN5 CPR-UN-EB PCR100 RESTING ECG, NON-INTERP, AHA PRO ECG LIGHT INTERFACE EXCL. PAT CABLE USB INTERFACE EXCL. 5 METER USB INTERFACE EXCL. PAT CABLE USB INTERFACE INCL. CPSP-UN-UC-D-T CPSP-UN-UC-D-PT CPSL-UN CPS-UN CPS-UN5 SYSTEM WITH TM ONLY SYSTEM WITH PC AND TM LIGHT SYSTEM WITH USB INTERFACE EXCL. INTERFACE EXCL. PAT CABLE SYSTEM WITH 5 METER USB INTERFACE EXCL TSB - CPWS Installation with Windows 7 32-bit REV A Page 1 of 7

2 CPR-UI-EB CPR-UN-EB-D CPR-UI-EB-D CPSP-UN-UC-D ABPM-6100 SPIRO-S SPIRO-NS-RS232 UPDT-WACPW-OW CPR-UN5-EB-D CPR-SN USB INTERFACE, ADULT INTERPRETATION INCL. USB INTERFACE INCL. & TAB ELECTRODE USB INTERFACE AND ADULT INTERPRETATION INCL. PAT CABLE & TAB ELECTRODE SYSTEM NO TM OR PC ABPM-6100 RECORDER WITH ACCESSORIES CPWS PC SPIRO W/ SYRINGE CPWS PC RS232 SPIRO NO SYRINGE WACPW UPGRADE, OUT OF WARRANTY USB INTERFACE (5m) INCLUDING & TAB ELECTRODE SET PRO ECG SYS W/SER INTRFACE EXCLUDING PAT CBL CPR100 REST ECG, AHA, SERIAL, NON INTERP CPS-UN-EC CPS-UN-EP CPS-UN-UC CPS-UN-UP ABPM-6100S SPIRO-NS SPIRO-S-RS232 UPDT-WACPW-CD CPR-UI5-EB-D CPR12-UN-EB CABLE CLIP (IEC) CABLE PUSH (IEC) CABLE CLIP (AHA) CABLE PUSH (AHA) ABPM SYSTEM W/6100 RECORDER& SOFTWARE CPWS PC SPIRO NO SYRINGE CPWS PC RS232 SPIRO W/ SYRINGE CARDIOPERFECT WKST,UPDATE USB INTERFACE (5m)AND ADULT INTERPRETATION INCLUDING & TAB ELECTRODE SET PRO ECG SYSTEM 1200 HZ WITH USB INTERFACE INCLUDING PATIENT CABLE CPR100 REST ECG, AHA, SERIAL, INTERP CPR100 REST EG, IEC, SERIAL, NON INTERP SYSTEM, INTERPRETIVE, WITH PC AND TM CPR100 REST ECG, IEC, SERIAL, INTERP TSB - CPWS Installation with Windows 7 32-bit REV A Page 2 of 7

3 SW Version: CPWS Serial No. / Lot Code: Applies to CPWS software; beginning Serial Number: Summary: Provide a process for installing CPWS Software on Microsoft Windows 7. This process is valid only on 32-bit versions of Windows 7 Home Premium and Windows 7 Professional editions. This bulletin is intended to be used by personnel with a working knowledge of the CPWS software installation and experience using Windows operating systems. Issue: Action: Reference to Standards: The released version of CPWS will not install on the Windows 7 operating system without issue. CPWS was not tested or expected to be compatible with Windows 7. An installation process has been tested on CPWS to be compatible with the above listed Windows 7, 32-bit operating systems. Using the findings of the installation validation process, this bulletin will describe how to correctly install CPWS on Windows 7, 32-bit as listed in the Summary section. Systems with serial (RS232) connected devices need be concerned only with the CPWS software installation portion of this procedure and can ignore all processes related to USB configuration. 21 CFR Part 820, ISO 13485, MPD SOP-0002 Updates: Technical Manual Service Plan Procedures Training Material Repair Tool Internet/Intranet Price List Other Service Strategy: Required Training: Required Tools: Required Materials: Quality Process for failed units or components: Standard TSB Distribution CPWS installation CD TSB - CPWS Installation with Windows 7 32-bit REV A Page 3 of 7

(A side Note: Once created, store the file in a remote location for use on other systems if needed.) a) Create a new text file (.txt). Click the Start icon and type notepad in the search field.

4 Procedure: Prerequisite: Full Administrative rights on the computer CPWS will be installed on. Pre-Installation: 1. Note: Do not connect any CPWS USB devices until after the software has been successfully installed. 2. Apply USB Selective Suspend Registry entry: Create a Registry editor file. (A side Note: Once created, store the file in a remote location for use on other systems if needed.) a) Create a new text file (.txt). Click the Start icon and type notepad in the search field. Hit Enter. Copy the boxed text below exactly and paste into the new text file. Windows Registry Editor Version 5.00 [HKEY_LOCAL_MACHINE\SYSTEM\CurrentControlSet\services\Usb] "DisableSelectiveSuspend"=dword: b) Save the file as USBselectiveSuspendDisable.reg. It is important to ensure the file has the.reg file extension (may need to enable show file extensions ) Close the file. c) Double click the USBselectiveSuspendDisable.reg file and acknowledge any UAC (User Account Control) messages. d) Click Yes and OK to the following messages (The path listed for the registry file may differ from the two screenshots below) TSB - CPWS Installation with Windows 7 32-bit REV A Page 4 of 7

3. Verify the UAC setting is correct. a) Click the Start icon and type uac in the search field. Hit Enter. b) Verify the UAC is set to the Default setting as shown in the screenshot below.

5 3. Verify the UAC setting is correct. a) Click the Start icon and type uac in the search field. Hit Enter. b) Verify the UAC is set to the Default setting as shown in the screenshot below. If an adjustment needs to be made you will need to restart the computer after making adjustments. c) RESTART THE COMPUTER if not prompted to do so. CPWS Software Installation, USB ECG and USB Spirometry device connection: 1. Perform the CPWS installation as described in the installation guide. If a Program Compatibility Assistant message appears as shown below always select This program installed correctly. Similar messages may appear multiple times TSB - CPWS Installation with Windows 7 32-bit REV A Page 5 of 7

2. Once the installation has completed insert the USB ProLink cable, and or USB Spirometer, into the USB ports. The drivers will load automatically and give confirmation they were installed correctly.

6 2. Once the installation has completed insert the USB ProLink cable, and or USB Spirometer, into the USB ports. The drivers will load automatically and give confirmation they were installed correctly. 3. IMPORTANT: Restart the computer after the device drivers have loaded correctly. ABPM with Keyspan adapter connection 1. An updated driver for the Keyspan adapter will need to be obtained from the internet. At the time of this bulletin release, the updated driver could be found at: 2. Install the driver BEFORE plugging in the Keyspan adapter TSB - CPWS Installation with Windows 7 32-bit REV A Page 6 of 7

7 Important configuration settings when not using local admin rights 1. Applying changes to Connection Setup: Windows 7 Home Premium - If the computer user is logged into Windows without local admin rights and attempts to change the server connection, the change will not take place and there will be no indication within the Connection Setup tool that the setting did not hold. In this situation the Server connection can be changed by right clicking on the Connection Setup shortcut and clicking on Run as administrator at which time the local administrator credentials will need to be supplied. Windows 7 Professional Similar to the situation described above, however the when attempting to run Connection Setup the user will be prompted for the local administrator credentials. Quality Documents: 2. Telemedicine: Windows 7 Professional The CCMailServer can be opened using a standard Windows user account however any settings change will not hold. Other than Telemedicine not working, there is no indication to the user that the change was not successful. Windows 7 Home Premium Similar to the statement above, a standard user can not configure CCMailServer. However in this case the user may see an exception error when attempting to make a change. With the Windows Firewall turned on, local admin credentials are required to allow access outside the Windows Firewall. This is only necessary the first time the MailServer is started. Notes: 1. Contact the Welch Allyn Complaints Department to initiate or process a medical device complaint resulting from this or other issues. 2. Drawings, illustrations, and part numbers in this document are for reference purposes only and subject to change. End of Bulletin Revision History Version Description Change # Init Release Date Appr A Initial Release D* D* D* D* D* - See SAP DIR for Change number, Approver Name and Date of Approval TSB - CPWS Installation with Windows 7 32-bit REV A Page 7 of 7