Additionally, all handheld analyzers currently in stock should be updated immediately with this software prior to shipping to customers.

Transcription

1 i-stat DISTRIBUTOR BULLETIN i-stat Software Release Summary October 2011 i-stat Portable Clinical Analyzer: JAMS064 CLEW A23 or C23 (for Japan only) i-stat 1 Analyzer: JAMS131, CLEW A23 i-stat 300F Analyzer (for FUSO Japan only): JAMS131, CLEW A23 Central Data Station Version 4: c (no change) Central Data Station Version 5: 5.25 (no change) Interface 5 Software: Version (no change) A new release of the i-stat software (names above) is now available with accompanying documentation on the Abbott Point of Care (APOC) website. Installation of this new software is mandatory for all handheld analyzers. The software packet must be in customer locations by 30 November The current software (CLEW x22) expires 21 December Additionally, all handheld analyzers currently in stock should be updated immediately with this software prior to shipping to customers. This bulletin summarizes the relevant changes contained in this software release and provides a list of the software and documentation components of the release that must be downloaded from the APOC website in order to support this software release. IMPORTANT INFORMATION The expiration date for the October 2011 software, CLEWs A23 and C23 is 20 June The text in the Intended Use section of the following Cartridge and Test Information Sheets has been updated: Sodium Potassium Chloride BUN/Urea Glucose Hematocrit Ionized Calcium PO 2 ph PCO 2 Total Carbon Dioxide/TCO 2 Lactate Celite ACT Kaolin ACT Cardiac Troponin I/cTnI Art: AD Rev. Date: 13-OCT

2 Several sections of the i-stat 1 System Manual were updated: The Table of Contents was updated to reflect current section and page listings. The Symbols area of Section 1 (Introduction) was updated to include the new FCC Symbol:. This symbol signifies that the product bearing the Federal Communications Commission logo complies with the specific requirements set forth by the FCC under Rules and Regulations, Title 47, Part 15 subpart B, for Class A devices. Section 2 (i-stat 1 Analyzer) was updated to change the Barometric Pressure specifications for the i-stat 1 handheld to the range of mmhg. Section 6 (i-stat 1 Downloader) was updated to delete the sentence: The Downloader and Downloader/Recharger have different power supply adapters that are not interchangeable. The current power supplies for the Downloader and Downloader/Recharger are interchangeable. The Flags area of Section 12 (Cartridge Testing) includes updated information regarding the appearance of the <> flag when the TCO2 result is <1 or >80 mmol/l. Section 19 (Troubleshooting the Analyzer) was updated to include recommended actions to be taken when the Internal Simulator test fails. Two sections of the i-stat System Manual were updated: The Table of Contents was updated to reflect current section and page listings. The Reportable Ranges area of Section 11 (Patient and Control Sample Testing) includes updated information regarding the appearance of the <> flag when the TCO2 result is <1 or >80 mmol/l. Two revised and four new Technical Bulletins are included in this update packet: The Support Services Technical Bulletin has been updated with the latest Distributor Support address and contact information. The i-stat 1 Downloader/Recharger (Model Number DRC-300) Technical Bulletin has updated instructions for configuring the DRC for network operation. The following three (3) new Technical Bulletins contain instructions for using the i-stat Software and Documentation CD-ROM to update the software in the i-stat 1 and i-stat PCA handhelds: Instructions for Updating i-stat 1 Handheld Software Network Options for Updating the i-stat 1 Handheld Instructions for Updating Software on the i-stat Portable Clinical Analyzer A new Technical Bulletin entitled i-stat Printer Rechargeable Battery Notice is included in the packet. This Technical Bulletin advises users that i-stat Printers that are unplugged from the AC adapter and turned off may experience battery drain that can leave the battery unable to be charged. To avoid reaching the state where the battery is unable to be charged, users are advised to: Charge the battery within 2 days after the Low Battery indicator illuminates. DO NOT place the printer into storage with the battery installed. Art: AD Rev. Date: 13-OCT

3 RELEVANT CHANGES i-stat 1 Handheld No relevant changes. i-stat Analyzer (200 series) No relevant changes. Central Data Station Version 5 No relevant changes. The current version is DISTRIBUTOR ONLY: DOCUMENTATION AND INSTRUCTIONS FOR UPDATING CUSTOMERS Abbott Point of Dare recommends the preparation of Update Kits for distribution to your customers. These kits should contain a software diskette or CD-ROM with the required files as listed below and paper copies of the appropriate documents listed under User Documentation below. ANALYZER SOFTWARE COMPONENTS The following archive file(s) must be downloaded from the APOC website. i-stat Analyzers All Countries (except Japan) Archive Title on the APOC Website: JAMS064, JAMS131, CLEW A23. Archive description: Name Checksum Contents SU064A23.exe Self extracting file that includes all files listed below Files included: Name Description JAMS064B.bin JAMS131C.bin A23.CLW Jammit.Exe Jammlite.Exe Copyclew.exe Update.cfg i-stat Portable Clinical Analyzer application i-stat 1 Analyzer application i-stat Analyzers CLEW file DOS Download utility for use with all analyzers Windows download utility for use with all analyzers DE installation Utility Configuration file used by Jammit/Jammlite Archive Title on the APOC website: Transfer.bat for Distribution Disk. Archive description: Name Checksum Contents Transfer.bat 1A5D02 Batch file to copy from floppy hard drive Note: Some of the software files may be self extracting zip files. The transfer.bat batch file automatically expands any existing zip files as it copies to C:\bins. Art: AD Rev. Date: 13-OCT

4 Japan ONLY: Archive Title on the APOC website: JAMS064, CLEW C23, JAMS131, CLEW A23. Archive description: Name Checksum Contents SU064C23.exe 665E6C5 Self extracting file that includes all files listed below Files included: Name Description JAMS064B.bin C23.CLW JAMS131C.bin A23.CLW Jammit.Exe Jammlite.Exe Copyclew.exe Update.cfg i-stat Portable Clinical Analyzer application i-stat Portable Clinical Analyzer CLEW file i-stat 1 Analyzer application i-stat 1 Analyzer CLEW file DOS download utility for use with all analyzers Windows download utility for use with all analyzers DE installation Utility Configuration file used by Jammit/Jammlite Note: i-stat 300F (FUSO) analyzers will not work with CLEW Cxx (K 2 EDTA). Code 13 will result if CLEW Cxx is installed into the analyzers. The series 300 analyzers must be customized to K 2 EDTA using the keypad. For details please read Technical Bulletin Hematocrit Customization in i-stat analyzers model 300 (for Japan only). CENTRAL DATA STATION SOFTWARE COMPONENT (no change) For customers who have CDS 5: All customers should already be on CDS Version Art: AD Rev. Date: 13-OCT

5 USER DOCUMENTATION The following user documentation file(s) must be downloaded from the APOC website. Multiple languages may be available. These documents are in Adobe Acrobat PDF format, and can be viewed and printed using the Adobe Acrobat application. Product Updates Title on APOC website: Software and Cartridge Test Information Update: October 2011 (art # XX A) Add/Delete i-stat System Manual (art # XX A) i-stat 1 System Manual (art # XX A) Technical Bulletins Title(s) on APOC website: For i-stat 1, 300F, and Portable Clinical Analyzer Users TB: Support Services (Updated) (art # XX P) TB: The i-stat 1 Downloader/Recharger (Model Number DRC-300) (New) (art # XXB) TB: The i-stat Printer Rechargeable Battery Notice (New) (art # XXB) Value Assignment Sheets of Fluids Please check the APOC website for new value assignment sheets for quality control and calibration verification solutions. i-stat 1 System Manual Sections Table of Contents (art # XX K) Section 1: Introduction (art # XX T) Section 2: i-stat 1 Analyzer (art # XX L) Section 5: Electronic Simulator (art # XX C) Section 6: i-stat Downloader (art # XX H) Section 12: Procedure for Cartridge Testing (art # XX H) Section 18: Updating the Software (art # XX F) Section 19: Troubleshooting the Analyzer (art # XX F, or G for UK English, Greek and Turkish languages) i-stat System Manual Sections: Table of Contents (art # XX H) Section 5: Electronic Simulator (art # XX B) Section 11: Patient and Control Sample Testing (art # XX C) Section 15: Updating the Software (art # XX D) Art: AD Rev. Date: 13-OCT

6 CTI Sheets Sodium (art # XX M) Potassium (art # XX J) Chloride (art # XX K) BUN/Urea (art # XX L) Glucose (art # XX M) Hematocrit (art # XX L, or M for Dutch) Ionized Calcium (art # XX L) PO 2 (art # XX K) ph (art # XX L) PCO 2 (art # XX P) Total Carbon Dioxide / TCO 2 (art # XX F) Lactate (art # XX K) Celite ACT (art # XX M) Kaolin ACT (art # XX K, or L for Swedish) Cardiac Troponin I / ctni (art # XX M) US Military Support The US Military will require the User Documentation to be in US English. In order to print documents for the US Military sites, please access the US Military Section of the APOC website. All user documents on the US Military site are current with the current software. Updates to System Manuals in Inventory Updated System Manuals are now posted on the APOC website in the International User Documentation Area. Please note that the Manuals appear in one large file. The documents appear consecutively just as they are arranged in the printed version of the System Manual. You can print the entire System Manual and replace the ones in inventory, or you may follow the Add/Delete sheets for i-stat Portable Clinical Analyzer and i-stat 1 handheld posted on the web to update the Manuals currently in inventory. Art: AD Rev. Date: 13-OCT