Printed or electronic versions of this document not accessed directly from the designated Welch Allyn Controlled Quality Information System are For Reference Only. Customer Service Bulletin Monitoring Products Welch Allyn, Inc.® 8500 SW Creekside Road Beaverton, Oregon 97008-7107 USA Tel: 1-315-685-4100 www.WelchAllyn.com Bulletin Type: As Needed Fax: 1-315-685-4653 Date: 2012-03-03 SAP DIR #: 20012927 Subject: CSB-CVSM/CIWS PROVISIONING MODEL NO. CAR Number: NA Distribution Scope: WA Customers, ASP's, and Distributors WA Technical Support, Product Service, & International Service Centers Product(s) Referenced: CVSM – Connex Vital Signs Monitor CIWS – Connex Integrated Wall System WAST – Welch Allyn Service Tool Gold licensed edition SW Version: CVSM- All CIWS –All WAST – 1.5.0 Serial No. / Lot Code: All Summary: Use the Welch Allyn Service Tool to provision the CVSM or CIWS with the Model number after replacing the MCE PCBA. The device must be provisioned with the Model number to send data to Connex VM. A new version of the PMP.dll file is available for the Welch Allyn Service Tool version 1.5.0 to provision the device with the Model number. Issue: Connex VM will not accept patient data from devices which do not provide a Model number to the Connex server. The Model number will not be present if the device’s MCE PCBA was replaced and the device was not provisioned with the Model number. Action: For devices failing to send patient data to Connex VM, check the device Advanced tab for the Model number, if no Model number is present use the Welch Allyn Service Tool to provision the device Model number. An updated PMP.dll (version 1.2.1.2) file is available for the Welch Allyn Service Tool version 1.5.0 that adds the capability to provision the device THIS INFORMATION IS THE PROPERTY OF WELCH ALLYN, INC. AND AS SUCH SHALL NOT BE REPRODUCED, COPIED, OR USED AS A BASIS FOR THE MANUFACTURE OR SALE OF EQUIPMENT OR DEVICES WITHOUT THE EXPRESS WRITTEN PERMISSION OF WELCH ALLYN, INC. Welch Allyn Bulletin Template (MPD FCD-1482 Rev. 4) DIR 20012927 v. A CSB-CVSM/CIWS PROVISIONING MODEL NO. Page 1 of 3 Printed or electronic versions of this document not accessed directly from the designated Welch Allyn Controlled Quality Information System are For Reference Only. Model number. If your Welch Allyn Service Tool does not support adding the model number to the device contact technical support to have your service tool updated. The Welch Allyn Service Tool version 1.5.1 will add this feature when released. When replacing the MCE PCBA in the CVSM or CIWS use the Welch Allyn Service Tool to provision the device with the correct Model number. See the procedure below to learn how to provision the device. Reference to 21 CFR Part 820, ISO 13485, MPD SOP-0002 Standards: References: 20012861 TSB-CVSM/CIWS PROVISIONING MODEL NO. Required Training: Completion of either the CVSM or CIWS online or classroom training: VSM6000SERREPW-TRN VSM 6000 Repair Web Training CIWSREPW-TRN Connex Integrated Wall System Web Training VSM6000SERREP-TRN CVSM Repair (Classroom Training) Required Tools: Welch Allyn Service Tool version 1.5.0.0 with gold license*: Order the CD, material number 103521 Download from Welch Allyn: http://www.welchallyn.com/promotions/services/serviceTool.htm * A gold license is provided with training Required Materials: WAST PMP Plugin v 1.2.1.2 software package available from PartnerConnect. If your Welch Allyn Service Tool does not allow you to enter the Model number call Welch Allyn Technical Support. Procedure: Using the Service Tool to provision the model number Note: You must have the PMP gold license to perform this procedure. 1. Launch the service tool and log on. 2. Select the device to be provisioned from the device list. 3. Select the configure tab. 4. In the Current settings box select Change..., to open the device configuration window. 5. In the device configuration window: a) Confirm the PMP serial number matches the device labeling (top box). If the serial number field is blank enter the serial number labeled on the device. b) Verify the Host Controller box has the serial of the MCE PCBA. If the serial number is not present contact Technical Support. c) In the Device model number box click the down arrow and select the THIS INFORMATION IS THE PROPERTY OF WELCH ALLYN, INC. AND AS SUCH SHALL NOT BE REPRODUCED, COPIED, OR USED AS A BASIS FOR THE MANUFACTURE OR SALE OF EQUIPMENT OR DEVICES WITHOUT THE EXPRESS WRITTEN PERMISSION OF WELCH ALLYN, INC. Welch Allyn Bulletin Template (MPD FCD-1482 Rev. 4) DIR 20012927 v. A CSB-CVSM/CIWS PROVISIONING MODEL NO. Page 2 of 3 Printed or electronic versions of this document not accessed directly from the designated Welch Allyn Controlled Quality Information System are For Reference Only. device model number from the drop down list Device Serial Number MCE PCBA Serial Number Device Model Number 6. Click the save button to provision the device. 7. Complete any other service to be performed and close the device tab before disconnecting the device from the computer. Wait for tab to close before disconnecting device, this allows upgrade information to be sent to PartnerConnect. 8. End of procedure 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* GS D* D* D* - Refer to SAP DIR digital signature log for approval details. THIS INFORMATION IS THE PROPERTY OF WELCH ALLYN, INC. AND AS SUCH SHALL NOT BE REPRODUCED, COPIED, OR USED AS A BASIS FOR THE MANUFACTURE OR SALE OF EQUIPMENT OR DEVICES WITHOUT THE EXPRESS WRITTEN PERMISSION OF WELCH ALLYN, INC. Welch Allyn Bulletin Template (MPD FCD-1482 Rev. 4) DIR 20012927 v. A CSB-CVSM/CIWS PROVISIONING MODEL NO. Page 3 of 3
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