Technical Service Bulletin

Transcription

1 Technical Service Bulletin Welch Allyn, Inc. Medical Products 4341 State Street Road Skaneateles Falls, New York USA Tel: (315) Fax: (315) Copyright 2007 Welch Allyn, Inc. All rights reserved. DATE: 4/20/09 SAP DIR #: Subject: TSB - CPWS Software Release Bulletin Type: Software update Product Family: CPWS Originator: SS / JR Service Engineering Department Author: Dave Savarese Issue: Release of Software Version for the CardioPerfect Workstation Distribution Key: Internal Welch Allyn distribution only External Welch Allyn distribution Reference: Change Number: CAR: N/A Solution Statement: The Welch Allyn Diagnostic Cardiology Team is pleased to announce a new version of software for the CardioPerfect Workstation. This Version (1.6.2) of the software incorporates several new enhancements that are outlined in this bulletin and is valid for Windows 2000 SP4, Windows XP SP2 or later and Windows Vista Business Edition SP1 or later. The software will be distributed via CD on all new orders starting March 27, 2009 and can be ordered as an update or upgrade for existing CardioPerfect users. PRODUCT IDENTIFIERS: Refer to table below to identify affected product, if applicable) and serial number range if the product is serialized, and or date code range. Product Number See list of affected product numbers below. Starting Serial Number CPR-UI-UB-D CPR-UN-UB-D CPRL-UN P/N Description P/N Description PCR100 Resting ECG, Interp, AHA PCR100 Resting ECG, Non-Interp, AHA PRO ECG Light System with USB Interface Excl. Pat Cable CPSP-UN-UC-D-P CPSP-UN-UC-D-T CPSP-UN-UC-D-PT PCE-210 PC Based Exercise Stress System with PC only PCE-210 PC Based Exercise Stress System with TM only PCE-210 PC Based Exercise Stress System with PC and TM TSB - CPWS Software Release Rev A Page 1 of 14

2 CPR-UN CPR-UN5 CPR-UN-EB CPR-UI-EB CPR-UN-EB-D CPR-UI-EB-D CPSP-UN-UC-D ABPM-6100 SPIRO-S UPDT-WACPW-OW PRO ECG System with USB Interface Excl. Pat Cable PRO ECG System with 5 Meter USB Interface Excl. Pat Cable PRO ECG System with USB Interface Incl. Pat Cable PRO ECG System with USB interface, Adult Interpretation incl. Pat Cable PRO ECG System with USB Interface Incl. Pat Cable & Tab Electrode PRO ECG System with USB Interface and Adult Interpretation Incl. Pat Cable & Tab Electrode PCE-210 PC Based Exercise Stress System no TM or PC ABPM-6100 RECORDER WITH ACCESSORIES CPWS PC SPIRO W/ SYRINGE WACPW UPGRADE, OUT OF WARRANTY CPSL-UN CPS-UN CPS-UN5 CPS-UN-EC CPS-UN-EP CPS-UN-UC CPS-UN-UP ABPM-6100S SPIRO-NS UPDT-WACPW-CD PRO Exercise ECG Light System with USB Interface excl. Pat Cable PRO Exercise ECG System with USB Interface Excl. Pat Cable PRO Exercise ECG System with 5 Meter USB Interface Excl. Pat Cable PRO Exercise ECG System with USB Interface Incl. Pat Cable Clip (IEC) PRO Exercise ECG System with USB Interface Incl. Pat Cable Push (IEC) PRO Exercise ECG System with USB Interface Incl. Pat Cable Clip (AHA) PRO Exercise ECG System with USB Interface Incl. Pat Cable Push (AHA) ABPM SYSTEM W/6100 RECORDER& SOFTWARE CPWS PC SPIRO NO SYRINGE CARDIOPERFECT WKST,UPDATE Classification of Action: Mandatory Optional Does Not Apply When: Immediate On Next Service At Agreed Upon Time Service Information and/or Requirements: Documentation required: N/A Software Upgrade o part numbers: UPDT-WACPW-CD Update to the latest CardioPerfect Software Version, under Warranty or extended service agreement. UPDT-WACPW-OW Update to the latest CardioPerfect Software Version Out of Warranty Users o Free of charge for customers under warranty. o Free of charge to any Spirometry customers, regardless of warranty status TSB - CPWS Software Release Rev A Page 2 of 14

3 File Link is on the CD Release Tools such as File Link, DB2MDW, BDT, and Patient number checkers were previously removed from the CD release. They have now been returned to the CD. The latest version of File Link 3.0 is on the CD. Database Version Change CPWS has an updated database version. This means that databases constructed from previous versions of CPWS (including and 1.6.1) will need to be upgraded before the software can access them. Databases can be made compatible by installing the database on the database server or executing DBBuilder.exe on the Database server. Enhancements: o Resting ECG Changes New Pediatric interpretation The algorithm is the same as the CP200: o Can handle both Standard and Pediatric lead set (V3R, V7 for V3, V5) o Adult vs. Pediatric algorithm is now always chosen on the basis of age (used to be based on lead set) o No separate license option for Pediatric anymore: if interpretation is enabled, Pediatric is also enabled. Customer Service no longer has to worry about selecting the Pediatric interpretation option. o Note: Pediatric lead set implementation in CPWS is still the same as it was, and is therefore different than CP TSB - CPWS Software Release Rev A Page 3 of 14

4 Pediatric Lead Set differences: CPWS vs. CP200 CPWS expects the user to apply the electrodes in the appropriate locations, and then attach the leads in sequence from right to left. CP200 uses standard lead placement for most leads, moves V3 to the V3R position and V5 to the V7 position. Pediatric Lead Placement Anatomical site (Right to Left) V3R V1 V2 V4 V6 V7 Lead wire CPWS V1 V2 V3 V4 V5 V6 Lead wire CP200 V3 V1 V2 V4 V6 V5 Added an auto-restart option for the Resting ECG acquisition to increase the chance of taking a good ECG. When any of the following issues happens, the recording will restart so the captured ECG will be clean: Framing-type errors caused by serial communication problems, for instance; on thin clients. Lead-off conditions. This new feature is active when recording 10-sec ECGs without pre-trigger TSB - CPWS Software Release Rev A Page 4 of 14

5 If you re stuck in this resting ECG restart mode because of continuous errors, you can override the restart feature through a new button: ECG printing will automatically select thicker lines on high-resolution printers (also for Stress): Can also still use Pen.Width = 2 in.rtm files TSB - CPWS Software Release Rev A Page 5 of 14

6 o Exercise ECG Changes METS interpolation METS values change gradually after load changes. Setting for minimum last stage duration has become obsolete with this improvement, but was not removed Interpolation slope can be changed in registry, HKEY_LOCAL_MACHINE\SOFTWARE\Cardio Control\MDW\Modules\Cardio Perfect ST\METS, TimeConstant_Treadmill, default = 120 TimeConstant_Ergometer, default = 40 ST bar chart colors follow ECG curve superimpose reference and current colors. Fixed bug that would delete stress variables from all tests when only one test was deleted TSB - CPWS Software Release Rev A Page 6 of 14

7 o Spirometry Changes CPWS meets ATS2005 compliance acceptability and repeatability Real-time curve display improved Centering and scaling used to be problematic for large volumes Exhale timer (Note: The Duration timer is designed for timing an effort per ATS guidelines. This is not a total effort timer and will reset to zero when backflow is detected.) Start of expiration fixed on x=0 Mild restriction was not always diagnosed correctly. Fixed reports where long parameter list was truncated. Flow values in best composite effort will all be from the same effort, volumes from whatever effort has the best value for that parameter (ATS spec) Improved end of expiration detection. For obstructed patients, could underestimate FVC: TSB - CPWS Software Release Rev A Page 7 of 14

8 If there is more than 1 inspiration, the one with Max(FIVC+FIV1) will be part of the FVC loop. (1.6.1 used only PIF) In this case, would have selected the wrong inspiratory part because the PIF is larger. Tidal V/T and F/T curves added: Tidal V/T Selected V/T TSB - CPWS Software Release Rev A Page 8 of 14

9 Parameters used for FEV1% calculation will always be shown: Interpretation strings will now show the translation. Interpretation also includes reversible airflow obstruction and bronchodilator response Fixed scaling on Social Security report. SVC predictions added to Hedenström. Post effort with long medication string was not saved. This has been corrected. Pre and Post curves are better distinguishable in Black and White report prints. SVC final result sometimes showed more than only best pre and best post. Corrected. Wang prediction norm has been added. Calibration data is saved for all users recalibration is no longer necessary when someone else logs in TSB - CPWS Software Release Rev A Page 9 of 14

10 o Database Changes Fixed issue where Vista Sync Center would close CPWS database connection MS SQL 2005 compatibility CPWS can connect to SQL 2000, SQL 2005, SQL 2008 servers. During installation, customer can choose between SQL 2000 MSDE (max. 2GB) and SQL 2005 Express (max. 4GB) for free local database engine installation. The reason for this choice is that 2005 Express can take up to 20 minutes to install. Use the SQL 2005 Express option for connecting to SQL 2005 or 2008 servers. Be aware that with the SQL 2005 Express option installed, there is no longer the option run or schedule backups within the Administrator tool. Backups may be possible with third party software. Tolerance for intermittent network When connection to the database is lost, CPWS will automatically try to reconnect. If saving data to the database did not succeed, a local.mdw file will be generated (ECG, Stress, Spiro) in the My Documents folder. Stored procedures for HIPAA log on/off now switch only the HIPAA-log related triggers. Pre would also disable CPSAPI triggers. Added and changed Spiro norms. o Installation Changes During installation, US defaults is automatically selected when in US locale TSB - CPWS Software Release Rev A Page 10 of 14

11 Installation can be pushed out through Windows Active Directory installs automatically on many workstations from one central server (refer to the Install manual on the CPWS CD). Note: It is expected that the customer using this option will have a qualified IT systems engineer on site that has knowledge and experience to follow this install process TSB - CPWS Software Release Rev A Page 11 of 14

12 o FileLink Changes FileLink is now a plug-in: Adds PDF and XML output capability Plug-in makes it compatible with thin clients Preferences are set-up through a menu on the FileLink plug-in Manually save tests by clicking the button on the FileLink tab in the module area TSB - CPWS Software Release Rev A Page 12 of 14

13 Components Required: N/A Materials Required: N/A Technician Qualifications: Prior knowledge of CPWS version 1.5.*, 1.6.0, and its operational challenges. Tools and Test Equipment Required: N/A Reporting / Recording of Findings: N/A (Attach inspection and service report, if applicable) Contact(s): N/A Parts Disposition: In-Stock: N/A Failed parts: N/A Date or Lot Code and Location: N/A TechView CD: N/A COMPLAINTS: Welch Allyn, Inc. Medical Customer Complaint process must be followed for any complaint activity resulting from this or other issues. Note: Drawings and/or illustrations and/or part numbers in this document are for reference purposes only and current to the date of this bulletin. Contact the Welch Allyn Service Engineering Department at Skaneateles Falls NY, USA if you have any questions about this bulletin, or to verify that you have the most current service information TSB - CPWS Software Release Rev A Page 13 of 14

14 Revision History VER REV DESCRIPTION ECN # INIT DATE APPR A Release D* DCS D* D* See SAP DIR for Change Number, Approver Name and Date of Approval End of Bulletin TSB - CPWS Software Release Rev A Page 14 of 14