S U P P L E M E N T A L R E L E A S E N O T E S Waters 2795 Separations Module Software Update Version 2.05 Firmware Update Version 2.05 Information Version 2.05 firmware incorporates improved checking of vial/sample position prior to injection of sample from that vial or position. These Supplemental Release Notes assume that the 2795 about to be upgraded with this software is already at Version 2.04. If this is not the case, contact Waters for a copy of earlier Supplemental Release Notes for information pertinent to that version. The information below is to be considered as an update to these manuals; Waters 2795 Separations Module Operator s Guide Rev. B, Waters 2795 Separations Module Quick Start Guide Rev. A and 2795 Separations Module Degasser Reference Sheet Rev. B (either in hardcopy form or as a combination CD- ROM/hardcopy Quick Start Guide and Reference Sheet form). Contents of this Release Waters 2795 Separations Module Software Update Version 2.05 Kit consists of: 2795 Firmware Update Disk, 1.44 MB, 3.5 inch Supplemental Release Notes (this document) Certificate of Structural Integrity System Qualification Letter Installation Notes The 2795 Separations Module software is updated by copying the software from the Waters 2795 Firmware Update Disk to the system FLASH ROM chips using the floppy disk drive on the front panel of the unit. Attention: If the floppy disk drive unit has not been used within the last month, it is advisable to exercise it before proceeding with the update by exporting a Separation Method or Sample Set. Since there is a possibility of a corrupt Method or Sample Set do not then import it. Attention: To prevent a mandatory service call to replace ROM chips, make sure that you do not power off the Separations Module during the software update procedure, unless specifically instructed to do so. To install the Update Version 2.05: 1. Insert the Waters 2795 Firmware Update Disk into the floppy disk drive on the front panel of the 2795. Waters, Alliance and Millennium are registered trademarks, and Empower is a trademark of Waters Corporation. All other trademarks are the sole property of their respective owners. Copyright 2007 Waters Corporation Page 1 of 6
2. Power on the 2795. The display will show A reprogramming utility was found. Press Enter to replace the current program. Press Clear to cancel and resume. Press Enter. 3. The display then shows Reading load utility from disk Please wait, followed by Alliance Binary Image Loader Compiled on August 20, 2002 10:54:14. 4. The display then shows Press Enter to Continue. Please Clear to Abort. Do not turn off the power until finished!! Press Enter. At this point, the update disk begins a check of the file system and of the configuration and/or methods. 4. The display shows Checking the file system.., then shows Checking the configuration and methods.., and then shows No errors were found. and Press Enter to continue. Press Enter. This update assumes the 2795 being updated already has Version 2.04 software, which prevents creation of corrupted methods. After steps 1 through 5 the 2795 is now ready to complete the software update and the display asks; 6. Do you want to import method templates? Press Enter for YES. Press Clear for NO. These templates are described in the Waters 2795 Separations Module Operator s Guide. Note: If you do not load these at this time you can import them later (see the Waters 2795 Separations Module Operator s Guide). If you have previously loaded the templates, they will be overwritten if you choose YES. If you press Enter the display shows Importing Method Templates and when complete shows Installing Version 2.05, Clear the display shows Installing Version 2.05, 7. When the display shows, Installing Version 2.05, Memory will be erased and reprogrammed! and the commands Press Enter to continue. and Press Clear to Abort., you should press Enter. 8. Last Warning! If you proceed, DO NOT turn off power! is displayed, followed by Press Enter to continue. Press Clear to Abort. Press Enter. 9. The display then shows Checking Program Integrity.Please wait. After a few minutes the display then shows, Erasing Memory..Please wait and DO NOT TURN POWER OFF! TURNING POWER OFF NOW WILL MAKE YOUR SYSTEM UNUSABLE! 10. After the memory has been erased, the display shows, Loading V 2.05 x percent complete and DO NOT TURN POWER OFF! TURNING POWER OFF NOW WILL MAKE YOUR SYSTEM UNUSABLE! The x percent complete represents the percentage of the new program that has been loaded and proceeds from zero (0) to one hundred (100) percent. 11. Once the entire program has been loaded, the display shows Program Load Complete and instructs Remove Floppy Disk and cycle power. Remove the disk, turn the Separations Module power switch to the OFF position, wait approximately 5 seconds, and then turn the power switch to the ON position. The Separations Module will go through its initialization sequence. Progress of initialization is viewable in the banner area of the display and when complete, the banner area displays Idle. 12. Verify 2795 Separations Module firmware revision (2.05), creation date (Jan 24, 2007 14:22:15) and checksum (7404F2CEH). From the 2795 Main Screen choose Diag, then Other Diagnotics and scroll down to Firmware Checksum. The checksum is listed, and if internally correct, is followed by the letters OK. Note: If your instrument is in a regulated environment and the firmware checksum and version number are confirmed, then the Installation Qualification is complete. See section on Instrument Qualification. Page 2 of 6
Items Documented Prior To Product Shipment (Ver 2.05) Improved Checking of Vial/Sample Position Prior To Injection Version 2.05 firmware incorporates improved checking of vial/sample position prior to injection of sample from that vial or position. On each injection, if a new plate is engaged, the X/Y mechanism's full range of travel is tested. Immediately after the new plate is engaged the needle is moved to the four corners of the plate grid and then back to home. If any of the X axis movements were unsuccessful an "X axis malfunction" error occurs. If any of the Y axis movements were unsuccessful a "Y axis malfunction" error occurs. On each injection, after the sample has been aspirated, the movement of the X/Y mechanism, as it travels back to the inject port, is checked. If any of the X axis movements are unsuccessful an "X axis malfunction" error occurs. If any of the Y axis movements are unsuccessful a "Y axis malfunction" error occurs. Should you observe either an X axis malfunction or a Y axis malfunction error that is due to a persistent hardware problem, the system will not be able to run. Repeated attempts to run the system will result in the same type of error being displayed. In such cases the hardware issue must be resolved please contact your local Waters office for assistance. Instrument Qualification The 2795 V2.05 firmware incorporates improved checking of vial/sample position prior to injection of sample from that vial or position), as noted above. This correction does not impact the actual functional performance of the instrument with respect to qualification. Therefore, installation of 2795 V2.05 software in an instrument having the minimum hardware requirements, is not considered to be a major product change and will not require total instrument or system re-qualification. If your Separations Module-based system is in a regulated (GXP) environment, Waters recommends that you perform the following procedures to verify consistent instrument/system performance before and after loading this firmware update. 1. Run system suitability analysis (on a well characterized standard) before and after installing this firmware update. Compare the results. If the before and after results agree to within the analytical method specifications, then the continued performance of the instrument/system is verified. 2. Record the check sum result to verify the software has loaded correctly. Record the new firmware revision number in your GXP documents. Items Documented Prior To Product Shipment (Ver 2.04 and earlier) Correct Use of Diagnostics Screens Whenever an operator is within the 2795 diagnostics, it is very important that ALL diagnostic screens be exited before any external control (Millennium32, Empower, MassLynx, etc.) is allowed. Adding New Sample Vials During a Run To minimize the risk of a vial/sample position being missed when inserting new vials or plates into the 2795 while the instrument is processing a sample set, the following guidelines should be followed; When adding vials/samples, wait at least 30 seconds after an injection is made (i.e. wait until the run time displayed on the front panel, or within the controlling software, is greater than 30 seconds). Minimize the length of time that the sample compartment door remains open. It is also good practice to make sure the sample compartment door is closed when time injection commands (selecting vial, washing the needle, drawing sample, etc.) are in the process of being carried out. Re-initialization of the System Page 3 of 6
It is good practice to re-initialize the instrument at least once a week: when all instruments (the 2795 and Detectors) are power-cycled (i.e., turn "off", wait for a minimum of 1 minute and then turn "on") on a regular basis), each instrument will perform a complete system initialization, including internal diagnostics and verifications. This helps ensure that the mechanical and electrical components as well as internal firmware, synchronize for proper operation. Minimizing Dust Ingress It is important that the optical sensors on a number of internal components not get covered in dust. If the instrument is in an area that is prone to accumulation of dust, Waters recommends the use of a Dust Filter Kit to minimize dust accumulation inside the instrument. This Filter Kit (includes floppy drive cover and rear panel plug) is standard on all 2795 s manufactured since December 2004, and are available as kits for earlier 2795 instruments. Improved Check Valve Performance As of June 2005, all 2795 Separations Modules and 2795 Performance Maintenance Kits have been delivered with PerformancePLUS check valves as standard; this check valve features a 1/8" ruby ball/sapphire seat. The original check valve (1/16" ruby ball/sapphire seat) is available as an option, along with 2 versions of ceramic check valve (ceramic ball and ceramic seat, either 1/8 or 1/16 ball diameter). Page 333 of the Appendix B1 (spare parts) of the 2795 Separations Module Operator s Guide should be amended as follows; The spare part number for the PerformancePLUS check valve is 700000254. The optional 1/16" ruby ball/sapphire seat check valve spare part number is WAT270941. The optional 1/16" ceramic check valve spare part number is 700002761. The optional 1/8" ceramic check valve spare part number is 700002399. Import of the Default Separation Method The 2795 Default Separation Method is resident in the 2795. It is not appropriate to attempt to import a method named Default, even if it was exported from the same unit. The creation of an invalid method may occur. Modification to Automatic Stroke Volume Functionality The Figure 5-4 ( Mobile Phase Screen ) is incorrect. The figures below show the settable Stroke Volumes. Composition Change Restriction The composition can no longer be changed from the Status page while the 2795 is under remote control. Page 4 of 6
Needle Wash Option The needle wash options Every Well and Every Inject work properly with each of the possible injection mode/ wash frequency combinations. The following lists show the steps taken when running a sample set containing separation methods employing each of the possible combinations. The sample set consists of injections made from the well/plate locations 1,1 1,1 1,1 1,2 1,2 2,2 2,2. Each line of the lists describes one injection cycle, from injection setup to the end of run time. Cycle time is increased if the wash/purge occurs before the injection, while it's decreased if the wash/purge occurs after the injection (or not at all). Note that a wash/purge occurs before the start of the first injection after power-up, as long as the current separation method has washing enabled. Sequential / Every inject: 1,1 = aspirate sample, inject sample, wash/purge 1,1 = aspirate sample, inject sample, wash/purge 1,1 = aspirate sample, inject sample, wash/purge (plate changes) 1,2 = aspirate sample, inject sample, wash/purge 1,2 = aspirate sample, inject sample, wash/purge (well changes) 2,2 = aspirate sample, inject sample, wash/purge 2,2 = aspirate sample, inject sample, wash/purge Sequential / Every well: 1,1 = aspirate sample, inject sample 1,1 = aspirate sample, inject sample 1,1 = aspirate sample, inject sample (plate changes) 1,2 = wash/purge, aspirate sample, inject sample 1,2 = aspirate sample, inject sample (well changes) 2,2 = wash/purge, aspirate sample, inject sample 2,2 = aspirate sample, inject sample Parallel / Every inject: 1,1 = aspirate sample, inject sample, wash/purge, aspirate next sample 1,1 = inject sample, wash/purge, aspirate next sample 1,1 = inject sample, wash/purge, (plate changes) aspirate next sample 1,2 = inject sample, wash/purge, aspirate next sample 1,2 = inject sample, wash/purge, (well changes) aspirate next sample 2,2 = inject sample, wash/purge, aspirate next sample 2,2 = inject sample, wash/purge Parallel / Every well: 1,1 = aspirate sample, inject sample, aspirate next sample 1,1 = inject sample, aspirate next sample Page 5 of 6
1,1 = inject sample, wash/purge, (plate changes) aspirate next sample 1,2 = inject sample, aspirate next sample 1,2 = inject sample, wash/purge, (well changes) aspirate next sample 2,2 = inject sample, aspirate next sample 2,2 = inject sample 2nd Generation Column Heater & New Column Heater/Cooler Subsequent to publication of the 2795 Operator s Guide Rev. B (P/N 71500279502, Rev B), Waters has replaced the original Column Heater with a 2nd generation Column Heater and introduced a new Column Heater/Cooler Module. The following notes update the column heater references within Rev. B of the 2795 Operator s Guide; Note that the Column Heater/Cooler module has its own built in power supply. Both of these modules are shipped with a copy of the Alliance Series Column Heater and Column Heater/Cooler Operator s Guide (P/N 71500049202, Rev A). The 2nd generation Column Heater allows you to maintain the column at temperatures from 5 C above ambient (minimum of 20 C) to 65 C in 1 C increments, (not up to 60 C as previously). The Column Heater/Cooler allows you to maintain the column at temperatures from 4 C (15 C below ambient) to 65 C, in 1 C increments. Note that the original Column Heater, the 2nd Generation Column Heater and the Column Heater/Cooler all share common dimensions. Illustrations of and text references to 2795 user interface screens and 2795 programming and diagnostics within the 2795 Operator s Guide Rev. B that relate to parameters Column Temp, Equilibrate, Initial Conds, Other Diagnostics Screen, Other Diagnostics Tests, before you perform the test, Action Parameters and 2410 and 410 Parameters should also refer to the available Column Heater/Cooler and it s programmable temperature range (per above). For information concerning the defrosting procedure of the Column Heater/Cooler, refer to Alliance Series Column Heater and Column Heater/Cooler Operator s Guide (P/N 71500049202, Rev A), page 72. For information concerning the physical and performance specifications of the Column Heater/Cooler, refer to Alliance Series Column Heater and Column Heater/Cooler Operator s Guide (P/N 71500049202, Rev A), pages 81 to 83. On page 332 within Table A-6 the column heater specification should read 20 C (5 C above ambient) to 60 C, in 1 C increments for the original Column Heater only. The 2nd Generation column heater specification should read 20 C (5 C above ambient) to 65 C, in 1 C increments. The upper temperature limit is 65 C and not 60 C. The Column Heater/Cooler specification should read 4 C (15 C below ambient) to 65 C, in 1 C increments. If a column heater (without cooler) is heating and a set point lower than the current temperature is entered, the column heater is commanded to stop heating. It will only resume heating when the temperature falls below the new set point. Subsequent to publication of the Alliance Series Column Heater and Column Heater/Cooler Operator s Guide (P/N 71500049202, Rev A), some improvements have been made to the Column Heater & Column Heater/Cooler modules that improve consistency of temperature control. The location of the temperature sensor has been changed within both the Column Heater & Column Heater/Cooler modules; the sensor is now located centrally within the compartment, between the 2 column mounting rails. This change has been in place since December 2005 for the Column Heater/Cooler, and since June 2006 for the Column Heater. Earlier modules can be updated to current standard please contact your local Waters office. Some changes have been incorporated into the door of the Column Heater & Column Heater/Cooler modules; the door contains an improved hinge mechanism and new foam inserts to better facilitate column outlet tubing connections to the detector module. This new door has been shipping as standard on both Column Heater & Column Heater/Cooler modules since May 2006. Earlier modules can be updated to current standard please contact your local Waters office. Page 6 of 6