20013314, CSB – Daylight Savings Time

20013314, CSB – Daylight Savings Time
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: 2012-10-29
SAP DIR #: 20013314
Subject:
CSB – Daylight Savings Time
CAR Number:
NA
Distribution Scope:
WA Customers
WA Technical Support, Product Service, & International Service Centers
Product(s) Referenced:
Connex Vital Signs Monitor, Connex Integrated Wall System, Connex VM
SW Version:
Connex Vital Signs Monitor 1.71.02, Connex Integrated Wall System
1.71.02; All previous software versions of Connex Vital Signs Monitor and
Connex Integrated Wall System
Serial No. / Lot Code:
Summary:
This document describes the handling of daylight savings time with the
1.71.02 software. It also describes handling of daylight savings time with all
previous versions of software. There are also instructions to verify the
version of device software as well as ensuring the appropriate setting is
enabled on 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.
DIR 20013314 CSB – CVSM / CIWS Daylight Savings Time rev A
Welch Allyn Bulletin Template (MPD FCD-1482 Rev. 4)
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Printed or electronic versions of this document not accessed directly from the designated Welch Allyn Controlled Quality Information System are For Reference Only.
Issue:
There is a change in how devices handle of daylight savings time.
Note regardless of version used all customers must have the following
settings in order to use Daylight Savings Time:
1) Automatically adjust for daylight savings time, reported by host setting
enabled on the CVSM / CIWS
2) Be connected to Connex VM or other EMR application (such as Cerner)
in order for synchronization to occur.
All versions of software prior to the release of 1.71.02
Connected devices will adjust for Daylight Savings Time five minutes
after being powered on and then every 24 hours thereafter.
Therefore after daylight savings time begins/ends, it is suggested for
connected customers to power-cycle the device and after five
minutes the device clock will synchronize. The power-cycle will force
the synchronization of the clock which would otherwise not occur
until the 24 hour time period based on the initial sync.
New feature with 1.71.02 software
•
Action:
Reference to
Standards:
Daylight savings time will now synchronize after 2 AM. It will
synchronize the clock each day after 2 AM. This will minimize the
time that the device is one hour behind/ahead on the days that
daylight saving time starts/ends. The CVSM will continue to sync five
minutes after it is turned on, but instead of syncing again 24 hours
later from the initial sync, it will now sync at 2 AM (Note: The time
each device is synchronized is spread out across the population of
devices and may vary up to 10 minutes to complete), and then every
2 AM thereafter until it is power-cycled.
Customers should be aware of the procedure required to synchronize their
devices to the appropriate time. If a customer desires to upgrade to 1.71.02
this is available via the Welch Allyn Service Tool.
21 CFR Part 820, ISO 13485, MPD SOP-0002
Additional References
Technical Experience:
None
Required Tools:
Material
Description
CVSM / CIWS
Device enabled for synchronization
System Requirements
Connectivity via Connex VM, or other interface
Required software
files:
NA
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.
DIR 20013314 CSB – CVSM / CIWS Daylight Savings Time rev A
Welch Allyn Bulletin Template (MPD FCD-1482 Rev. 4)
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Printed or electronic versions of this document not accessed directly from the designated Welch Allyn Controlled Quality Information System are For Reference Only.
Quality Process for
failed units or
components:
Procedure:
NA
Verify software version and verify device setting is enabled
Check for
device software
version here
1) Customer should press the settings tab and view the software version listed. This will inform what
software version is loaded on the devices.
2) In the advanced settings menu, on the General tab, touch the date / time tab.
3) Verify the automatically adjust daylight savings time, reported by host is enabled.
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
A
Description
Change #
CSB – CVSM/CIWS Daylight Savings Time
Init
KAA
Release Date
Appr
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.
DIR 20013314 CSB – CVSM / CIWS Daylight Savings Time rev A
Welch Allyn Bulletin Template (MPD FCD-1482 Rev. 4)
Page 3 of 3
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