Date: SAP DIR #: TSB CPWS Version Software Release

Transcription

1 Technical Service Bulletin Welch Allyn, Inc State Street Rad Skaneateles Falls, New Yrk USA Cardi Prducts Bulletin Type: As Needed Tel: Fax: Date: SAP DIR #: Subject: CAR Number: Distributin Scpe: TSB CPWS Versin Sftware Release N/A WA Internal WA Technical Supprt, Prduct Service, & Internatinal Service Centers Prduct(s) Referenced: Prduct Number See list f affected prduct numbers belw. Starting Serial Number Part # Descriptin CONNECTIVITY KIT,CPX00 TO CPWS PCR100 AHA W/INTERP,SPIRO,SYRINGE PRO ECG IEC W/INTERP,SPIRO,SYRINGE PCR100 AHA W/INTERP, ABPM PRO ECG IEC W/INTERP, ABPM CPWS ABPM AND SPIRO W/SYRINGE PCR100 AHA,SPIRO,SYRINGE PRO ECG IEC,SPIRO,SYRINGE PCR100 AHA, ABPM PRO ECG IEC, ABPM PCR100 AHA,SPIRO,SYRINGE, ABPM PRO ECG IEC,SPIRO,SYRINGE, ABPM PCR100 AHA W/INTERP,SPIRO,SYRINGE,ABPM PRO ECG IEC W/INTERP,SPIRO,SYRINGE,ABPM PCE210 AHA STRESS, W/INTERP,PC,TM PRO ECG STRESS IEC W/INTERP,CLIP Welch Allyn Bulletin Template (MPD FCD-1482 Rev. 4) Page 1 f 9

2 PCR100 RESTING ECG, NON-INTERP, AHA, 3M PCR100 RESTING ECG, NON-INTERP, AHA, 5M CPR100 Rest ECG, AHA, Serial, nn interp CPR100 Rest ECG, AHA, Serial, interp CPR100 Rest ECG, IEC, Serial, nn interp CPR100 Rest ECG, IEC, Serial, interp CP50 CONNECTIVITY KIT ABPM-6100C ABPM-6100 with Chinese SW ABPM-6100S ABPM SYSTEM W/6100 RECORDER& SOFTWARE ABP-SW ABPM Cardi Perfect Sftware CCW-UPCPWR CPWIN REST.UPGRD WACPW REST. ECG CCW-UPST DOS STRESS,UPGRD WACPW STRESS ECG CPE-CN-EB-D CER100 PDA REST. ECG, NON-INTERP, IEC CPR12-UN-EB PRO ECG SYSTEM 1200 HZ WITH CPR-SN PRO ECG SYS W/SER INTRFCEXCL. PAT CBL CPR-UI5-EB-D PRO ECG 5M USB,INTERP,CABLE DISP ELECT CPR-UI-EB PRO ECG SYS W/ USB INTERP & INTRFC,ADULT CPR-UI-EB-D PRO ECG SYSTEM WITH USB INTERP CPR-UI-UB-D CARDIOPERFECT PRO REST SYS CPR-UN PRO ECG SYS600 HZ W/USB INTRFC EXCL.PAT CPR-UN5 PRO RESTING ECG SYSTEM W/ 5MT CPR-UN5-EB-D PCR100 RESTING ECG,NON-INTERP,IEC (5M) CPR-UN-EB PRO ECG SYS W/USB INTRFCE INCL.PAT CBL CPR-UN-EB-D PCR100 RESTING ECG,NON-INTERP,IEC CPR-UN-UB-D CARDIOPERFECT PRO REST SYS CPR-UN-UB-D-1200 CARDIOPERFECT PRO REST SYS CPR-UPG-LTU UPGRADE FROM RESTING ECG CPR-UPG-MD-1 UPGRADE FROM MDR TO CPR-UN CPR-UPG-POR-1 UPGRADE FROM POR TO CPR-UN CPR-UPG-POR-3 UPGRADE FROM POR TO CPR-UN CPSL-UN PRO EXER ECG LGHT SYS 600HZ W/USB INTRFC CPSP-UN-UC-D PCE210,STRESS,NON-INTERP,AHA,NO PC,NO TM CPSP-UN-UC-D-P PCE210,STRESS,NON-INTERP,AHA,PC,NO TM CPSP-UN-UC-D-PT PCE210,STRESS,NON-INTERP,AHA,PC,TM CPSP-UN-UC-D-T PCE210,STRESS,NON-INTERP,AHA,TM CPS-UN PRO EXR ECG SYS 600HZ W/USB INTRFCE EXCL CPS-UN5 PRO STREE ECG SYSTEM W/ 5MT CPS-UN-EC PCE200,STRESS,NON-INTERP,IEC,CLIP CPS-UN-EP PCE200,STRESS,NON-INTERP,IEC,PUSH CPS-UPG-LTU SW UPGRD WACPW LITE TO FULL STRESS CPS-UPG-MDS-1 UPGRADE FROM MDS TO CPS-UN PE-PROCM-LNK-GB UPGRADE SET FOR CPR TO CPE SYS Welch Allyn Bulletin Template (MPD FCD-1482 Rev. 4) Page 2 f 9

3 REC-SW RE-SW-ECG RE-SW-HRV RE-SW-MEANS RE-SW-PEDIA RE-SW-VCG SE-UPG-USB SPIRO-NS SPIRO-NS-RS232 SPIRO-S SPIRO-S-RS232 SP-SW SW-CCW-CD SW-CCW-LIC SW-CCW-LIC-UPD SW-CCW-TELEM SW-UPD-1 SW-UPD-2 SW-UPD-3 UPDT-WACPW-CD UPGL-UN UPG-UN UPG-UN-UC-D UPG-UN-UC-D-T WACP WORKSTATION EVENT ECG CARDIOPERFECT PRO CP WORKSTATION SW TEST HEART RATE VARIABILITY OPTION FOR WACPW CARDIOPERFECT PRO REST ECG INTERPRET SW PEDIATRIC AUTO RST-ECG INTERP VECTORCARDIOGRAM (RECONSTR.12 UPGRD MD SYSTO EXER TEST USB INTERFACE CPWS PC SPIRO NO SYRINGE CPWS PC SPIRO NO SYRINGE, RS232 CPWS PC SPIRO W/ SYRINGE CPWS PC SPIRO W/ SYRINGE, RS232 WACP W/STN SP SOFTWARE (SP-SW) CCW CD-ROM(FOR SERVICE PACK) WACPW SOFTWARE LICENSE CCW SOFTWARE VIEWING LICENSE UPDATE CARDIOPERFECT PRO TELEMED OPTION UPDATE TO CCW UPDATE TO CCW UPDATE SOFTWARE CCW CARDIOPERFECT WKST,UPDATE PRO EXER ECG LGT UPGRD FROM CPRL EXCL PRO EXER ECG UPGRD FROM CPR EXCL PAT CBL UPGRADE REST.PCR100 TO STRESS PCE200/210 UPGRD RST.PCR100 TO STRESS PCE200/210+TM Welch Allyn Bulletin Template (MPD FCD-1482 Rev. 4) Page 3 f 9

4 SW Versin: Summary: The Welch Allyn Diagnstic Cardilgy Team is pleased t annunce a new versin f sftware fr the CardiPerfect Wrkstatin (CPWS). This Versin (1.6.3) f the sftware incrprates several new supprt enhancements that are utlined in this bulletin. This newest versin is nw valid fr Thin Client with USB ECG, the Windws 7 Operating System as well as limited* supprt fr 64-bit Operating Systems. The sftware will be distributed via CD n all new rders starting Octber 13, 2010 and can be rdered as an update r upgrade fr existing CardiPerfect users. Issue: New sftware release fr imprved thin client ECG supprt, Windws 7 cmpatibility and limited* 64-bit OS supprt. *See CPWS Supprted Operating systems Sftware changes & enhancements Installatin Changes ECG and Spirmetry drivers are nw selectable frm within the main installatin. New Cnnectivity Tls menu n the main installer screen gives easy access t: FileLink installatin The new PerfectLink installer The CPWS Tls flder n the CD Welch Allyn Bulletin Template (MPD FCD-1482 Rev. 4) Page 4 f 9

5 New PROlink USB Driver This driver has passed WHQL testing and is signed. This means that the new driver has been certified by Windws Hardware Quality Lab and will nt display the warning therwise assciated with unsigned drivers. The new driver nw supprts bth 32-bit (x86) and 64-bit (x64) systems. Windws will n lnger require Administratr rights when installing this driver n a new USB prt. During first installatin, we n lnger have t plug the PROlink USB device int each USB prt n the PC. Cardi Perfect Pr-Link USB has a new hme in Device Manager: In 1.6.2: 1.6.3: CPWS Supprted Operating Systems Nte that Windws 2000 is n lnger supprted. Significant additins include Windws 7 supprt and 64-bit supprt fr USB ECG and ABPM. On the Client (thick client) On the Server Database XP SP2 r higher Windws 2003 Server SQL 2000 Vista Business SP1 r later Windws 2008 Server SQL 2005 Windws 7 Hme Premium, Prfessinal, Ultimate ECG, ABPM supprted n 64-bit, Spir nly n 64-bit with serial & KeySpan adapter Windws 2008 R2 SQL 2008, if 2005 cmpatibility pack* installed. 32 & 64-bit servers supprted. Nt cmpatible with SQL 2008 R2 at this time *The 2005 cmpatibility fr SQL 2008 is part f the SQL 2008 feature pack, see link: 923F-58A033D316E1&displaylang=en Welch Allyn Bulletin Template (MPD FCD-1482 Rev. 4) Page 5 f 9

6 USB Thin Client Supprt PerfectLink - Welch Allyn s trademark slutin fr Thin Client supprt. Supprted n bth Micrsft RDP and Citrix ICA. Install the CPWS sftware n the server and install PerfectLink n the Thin Clients. See the installatin manual n the CD fr detailed instructins. Sftware slutin, wrks with PROlink ECG USB hardware Uses a fast data link between client and server called a Virtual Channel. This uses the same technlgy fund within Remte Desktp Services (ver RDP) r independent cmputing architecture (ICA) prtcls and cnfrms t their encryptin, bandwidth restrictin, and priritizatin verride capabilities. N prt mapping required Fast data transfer: can handle slwer netwrks, sme buffering in case the netwrk briefly drps ut. The PerfectLink installer autmatically installs itself as a plug-in fr all versins f Citrix ICA and Micrsft RDP clients. The PRO-Link ECG USB driver is included with the installer package, and n ther sftware is necessary n the client. PerfectLink must be cnfigured as a prt setting listed under Settings>ECG>Recrder tab. The setting is nly visible within a Thin Client sessin. PerfectLink supprted client perating systems: Client OS (thin client) 32-bit 64-bit Windws 2000 x Windws XP x x Windws XP Embedded x Windws Vista x x Windws 7 x x Welch Allyn Bulletin Template (MPD FCD-1482 Rev. 4) Page 6 f 9

7 Thin Client cnfiguratins within CPWS ECG Use PROlink USB and PerfectLink. N special parts are needed fr ECG thin client. Existing thin client kits with serial cable and battery pack will be bsleted. Spir Requires prt mapping at this time. Use USB Spirmeter if the client runs n 32-bit, need KeySpan + RS232 spirmeter n 64-bit. The USB device will still need COM prt mapping. USB Spirmetry is planned t be cmpatible with PerfectLink in versin ABPM Will still need COM prt mapping. It has nt been decided if and when PerfectLink will be implemented fr ABPM Stress Due t lengthy data transfers and cncern ver pssible netwrk (infrastructure) drputs, The XECG mdule will nt be supprted n Thin Clients. Cmpatibility n 64-bit systems ECG & Stress Spir ABPM PROlink USB is supprted n 32-bit and 64-bit perating systems Spir USB is nly available n 32-bit. Fr Spir n 64-bit, use a serial Spirmeter with a KeySpan adapter: SPIRO-(N)S-RS232 USB cmpatibility with PerfectLink is planned fr V1.6.4 release. The KeySpan adapter has a 64-bit driver. Planned Part number changes SPIRO-S-RS232 SPIRO-NS-RS (Obslete) (Obslete) Serial Spirmeter. These parts cntain a KeySpan serialt-usb adapter. Yu need this fr running Spir n 64-bit systems. These parts will becme available in the near future. Old ECG thin client parts are nw bslete. Welch Allyn Bulletin Template (MPD FCD-1482 Rev. 4) Page 7 f 9

8 Bug Fixes: Fixed crash at exit f CPWS after having used Spir features Fixed telemedicine issues with direct scket cnnectins Imprved installatin n SQL 2008 database (will warn abut installing the SQL 2005 backward cmpatibility pack if needed) If SQL installatin failed, the installer will give an errr and exit. This prevents class nt registered errr shwn by dbbuilder if the SQL installatin had nt succeeded. Fixed WDM handle errr issues with ECG USB new WHQL-cmpliant driver. Fixed this applicatin may nt have installed crrectly message that Windws 7/Vista wuld pp up after running cnnectin setup utility. Knwn Issues: Hibernatin / Standby may cause CPWS t nt ntice the PROlink USB driver. T Remedy: Unplug & re-insert the USB plug, r Disable Hibernatin / Standby n the PC (Cntrl Panel Pwer Optins) New ECG driver: Manual install f driver n existing cmputers is currently nt supprted. Any driver update shuld be accmpanied by the sftware. We re reviewing safety & efficacy implicatins f uplading the new driver t the Micrsft driver dwnlad site, which wuld allw the driver t be updated frm Device Manager. Shuld we decide t make the driver available in that manner, then a separate TSB will be issued. 64-bit and certain Vista/Windws 7 cnfiguratins will disallw access t registry and sme areas under file system. T remedy: set Full Cntrl permissins fr Users n HKLM\Sftware\Cardi Cntrl (Regedit) set Full Cntrl permissins fr Users n HKLM\Sftware\Spirmetry (Regedit) set Full Cntrl permissins fr Users n prgram files\cardi Cntrl (Explrer) Citrix n Server 2008: need t ensure that the cnfigured CPWS applicatin path exactly matches the ne displayed in Windws Explrer (case sensitive!!!). If nt, the fllwing errr will be shwn when starting CPWS in the thin client envirnment: An attempt was made t write t a read nly registry key. If CardiPerfect was started as a Citrix published applicatin, ensure the Lcatin Cmmand Line path matches the letter casing f the actual applicatin path. If a custmer installs CPWS n a system with SQL Server already installed, and with a nn-standard sa (system administratr) passwrd, they will be prmpted t enter the database credentials twice. The setup will nt install against a default instance f SQL 2008 R2 (database install). On such a system: Install Sftware nly. Manually install a supprted SQL Server in an instance. Manually create the database in that instance. Cnfigure CPWS fr that instance. Welch Allyn Bulletin Template (MPD FCD-1482 Rev. 4) Page 8 f 9

9 On x64, there is n chice fr database engine when ding a database install. MSDE 2000 will always be used. If a different SQL versin is desired, install that versin manually. On Vista and Windws 7, a message may appear at the end f the installatin prcess saying that the Spirmetry driver may nt have been installed crrectly. This warning can safely be ignred, just click This prgram installed successfully. Actin: Reference t Standards: Service Strategy: Required Tls: Required Materials: Quality Prcess fr failed units r cmpnents: Prcedure: Use apprpriate Update CD part number(s) listed abve fr custmers when needed. 21 CFR Part 820, ISO 13485, MPD SOP-0002 Standard TSB Distributin N/A CPWS CD, material number N/A Refer t this TSB and Installatin dcumentatin lcated n the CPWS CD. Quality Dcuments: All service centers using SAP t recrd service transactins: Fr each custmer serviced, recrd the service activity in SAP. All ther service centers and Field Service: Fr each custmer serviced, cmplete and file a service reprt and attach t the service DHR. Ntes: 1. Cntact the Welch Allyn Cmplaints Department t initiate r prcess a medical device cmplaint resulting frm this r ther issues. 2. Drawings, illustratins, and part numbers in this dcument are fr reference purpses nly and subject t change. End f Bulletin Revisin Histry Versin Descriptin Change # Init Release Date Appr A Initial Release D* D* D* D* D* - See SAP DIR fr Change number, Apprver Name and Date f Apprval Welch Allyn Bulletin Template (MPD FCD-1482 Rev. 4) Page 9 f 9