The instrument drivers and firmware in Driver Pack 4 support these ACQUITY UPLC systems: ACQUITY UPLC Systems with 2D Technology

Transcription

1 R E L E A S E N O T E S Waters Driver Pack 4 Driver Pack 4 includes instrument drivers and firmware required to control Waters instruments, as well as helpful utility applications. The driver pack is compatible with Empower, MassLynx, and specific, third-party data systems. It is not compatible with ACQUITY UPLC IVD-marked systems. The instrument drivers and firmware in Driver Pack 4 support these ACQUITY UPLC systems: ACQUITY UPLC System ACQUITY UPLC H-Class System ACQUITY UPLC H-Class Bio System ACQUITY UPLC I-Class System ACQUITY UPLC Systems with 2D Technology Driver Pack 4 updates the June 2011 Driver Pack. It contains many new features and enhancements. See What s new in this release for detailed information about the improvements included in Driver Pack 4. For instructions about how to install Driver Pack 4, see Driver Pack 4 Installation and Configuration Guide. For information regarding the configuration of Empower Enterprise networks, see Empower 3 Installation, Configuration, and Upgrade Guide. Table of Contents What s new in this release... 2 Driver Pack 4 contents... 4 Instrument driver and firmware versions... 6 Supported Waters and third-party... 9 Defects addressed by this release Known issues in this release Anti-virus considerations Requalification guidelines Contact Waters Technical Service ACQUITY, ACQUITY UPLC, Connections INSIGHT, Empower, MassLynx, nanoacquity UPLC, THE SCIENCE OF WHAT S POSSIBLE. and Waters are registered trademarks and Auto Blend Plus, ecord, LAC/E 32, and Q-Tof are trademarks of Waters Corporation. All other trademarks are the sole property of their respective owners. Copyright 2013 Waters Corporation * * *Rev.A* Page 1 of 21

2 What s new in this release Driver Pack 4 implements new features, enhancements, and defect corrections to the instrument drivers, firmware, and utility applications included in the driver pack. New features Instrument or System Deployment Manager BSM and CM-A QSM QSM SM-FL and SM-FTN SM-FTN Console Console Utilities Description You can now run multiple driver pack versions on a single Empower Enterprise network. Previously, it was necessary to install the same driver pack on all Empower LAC/E 32 modules, Empower clients, and Citrix servers on the network. Driver Pack 4, however, can be installed on individual LAC/E 32 modules, as long as it is also installed on all of the Empower clients and Citrix servers on the network. This feature makes it possible to add new LAC/E 32 modules to the network without upgrading and requalifying the existing LAC/E 32 modules. For further information see the Driver Pack 4 Installation and Configuration Guide. New Verify Instrument Driver Files application, to verify driver installation on non-empower systems. 2D Repeat parameter added to instrument methods allows the gradient table and timed-event table to repeat throughout the run, allowing for two-dimensional chromatography. Flow rate range increased to 2.2 ml/min. Correspondingly, the flow/pressure envelope is now: psi from 0 ml/min to 1 ml/min psi to 7800 psi, linear, from 1 ml/min to 2.2 ml/min Ability to import to and export from the solvent library. New sample- compartment temperature test helps determine whether the sample heater/cooler is operating within specifications. The test can be found in the sample manager section of the console under the Troubleshoot menu. See the console s online help for a description of this test. Injection valve can now be cycled via the timed-event table, to help reduce carryover. Instrument driver versions on both the client and server, as well as the installed driver versions and firmware versions, now appear in the Help > About dialog. Maintenance summaries for the BSM, CM/CM-A, QSM, SM, SM-FL, and SM-FTN can be viewed and printed. New application allows a single workstation to switch between controlling an ACQUITY system and a nanoacquity system. Page 2 of 21

3 Enhancements Instrument or Deployment Manager Deployment Manager Multiple instruments BSM QSM QSM QSM QSM SM-FTN CM CM, CM-A Utilities Description Improved robustness and error handling (better detection, logging, visibility). Improved compatibility with the Empower Verify Files utility. Wide-area networks with latencies of up to 300 ms are now supported for the BSM, QSM, SM, SM-FL, SM-FTN, TUV and PDA. High latency networks previously caused their instrument drivers to freeze or terminate. When you run an Empower system that includes two BSMs, their order in the console tree now always matches that of the Empower system definition. Prime function enhanced by the ability to prime to a specific composition as well as apply a composition at the end of the prime. The QSM method print content is enhanced to include the buffer system details and the compositional percentages in Auto Blend Plus mode. The QSM will initiate the system s inject start to trigger any Ethernet detectors or column managers on its next intake stroke after receiving an inject-start, contact-closure, rear-panel event. This support permits operation without an ACQUITY Autosampler (SM, SM-FTN, or SM-FL) in the system, allowing for control with external devices. The QSM now supports a passive check valve option in addition to Waters Intelligent Intake Valve (i 2 Valve) operation, for use in certain applications. Autoaddition capabilities improved with the addition of the Mix Cycles and Mix Stroke Volume method parameters. The column manager post-run report is extended to include the part number, and any recorded ecord comments. The column manager now stops the solvent flow for any change in selected column position. Previously, the flow would not stop when pressure was less than 500 psi. Columns Calculator gradients can now be dragged-and-dropped to the BSM method editor. Page 3 of 21

4 Driver Pack 4 contents The Driver Pack 4 DVD includes these items: All current instrument drivers and firmware files for ACQUITY UPLC instruments and detectors Utilities for use with ACQUITY UPLC systems Driver Pack 4 Deployment Manager ACQUITY UPLC Console These supporting materials accompany the Driver Pack 4 DVD: Driver Pack 4 Installation and Configuration Guide on a documentation CD Driver Pack 4 release notes Pointer card with information about Waters website Instrument drivers and s Driver or Version 2489 Detector Detector 1.30 Binary Solvent Manager 1.60 Column Manager 1.60 Columns Calculator 1.60 Connections INSIGHT 3.2 ELS Detector (also supports 2420 and 2424) 1.40 FLR Detector 1.40 Local Console Controller 1.60 PDA Detector 1.60 Quaternary Solvent Manager 1.60 RI Detector 1.40 Sample Manager 1.60 Sample Manager-FTN 1.60 TUV Detector 1.60 Waters Pump Control Software 3.10 Waters SQ Detector 1.41 Waters TQ Detector 1.41 Deployment Manager 3.1 ICS Companion 1.60 Page 4 of 21

5 Firmware Firmware (SFT files) Version Checksum 2420 Detector x21A5BED Detector x21A5B8D Detector xBD0669D Detector xEDB36196 Binary Solvent Manager x36F220A9 Column Manager (Active) x1B55819D Column Manager x8E9D1DC0 ELS Detector x216F9370 FLR Detector xD99DEFB5 PDA Detector (1) xF7ED509A PDA Detector (2) xDCFE9340 Quaternary Solvent Manager xA9C8E138 RI Detector xAA39BF4C Sample Manager x47F616CE Sample Manager-FL x37CC5868 Sample Manager-FTN x35D5392B Sample Organizer x96FA9AB0 TUV Detector (1) xBC170FAF TUV Detector (2) xD71E0EDA Note: The installers for the ELS, FLR, RI, 2489, and 2998 detectors have been updated to address installation issues. Because their version numbers changed, they appear as upgrades during installation. Nevertheless the files they install remain identical to the currently released versions. Performing upgrades of those s is therefore harmless. Page 5 of 21

6 Instrument driver and firmware versions ACQUITY UPLC System Modules Part number Software version Firmware version ACQUITY UPLC BSM Binary Solvent Manager, ACQUITY UPLC SM , Sample Manager, Binary Solvent Manager, Sample Manager, ACQUITY UPLC HTCH N/A N/A ACQUITY UPLC Column Heater N/A N/A N/A ACQUITY UPLC CM ACQUITY UPLC Column Heater/Cooler Column Manager, N/A N/A Column Manager, v ACQUITY UPLC H-Class and H-Class Bio Systems Modules Part number Software version Firmware version ACQUITY UPLC H-Class QSM/ H-Class Bio QSM ACQUITY UPLC H-Class SM-FTN / H-Class Bio SM-FTN ACQUITY UPLC H-Class CH-A / H-Class Bio CH-A ACQUITY UPLC H-Class CM-A / H-Class Bio CM-A ACQUITY UPLC H-Class CM-Aux / H-Class Bio CM-Aux , , Quaternary Solvent Manager, Sample Manager- FTN, N/A N/A Column Manager, N/A N/A Quaternary Solvent Manager, Sample Manager- FTN, Column Manager (Active), Page 6 of 21

7 ACQUITY UPLC I-Class System Modules Part number Software version Firmware version ACQUITY UPLC I-Class BSM Binary Solvent Manager, ACQUITY UPLC I-Class SM-FTN Sample Manager- FTN, ACQUITY UPLC I-Class SM-FL Sample Manager, ACQUITY UPLC I-Class CH-A N/A N/A ACQUITY UPLC I-Class CM-A Column Manager, Detectors Binary Solvent Manager, Sample Manager- FTN, Sample Manager- FL, Column Manager (Active), Modules Compatible systems Part number Software version Firmware version ACQUITY UPLC TUV All UPLC systems TUV Detector, TUV Detector (1), ACQUITY UPLC TUV Thermally Enhanced All UPLC systems TUV Detector, TUV Detector (2), ACQUITY UPLC PDA All UPLC systems PDA Detector, PDA Detector (1), ACQUITY UPLC PDA Thermally Enhanced All UPLC systems PDA Detector, PDA Detector (2), ACQUITY UPLC epda All UPLC systems PDA Detector, ACQUITY UPLC epda Thermally Enhanced All UPLC systems PDA Detector, ACQUITY UPLC FLR All UPLC systems FLR Detector, v1.40 ACQUITY UPLC ELS All UPLC systems ELS Detector, v1.40 Waters 2420 ELS Detector Waters HPLC Systems ELS Detector, v1.40 PDA Detector (1), PDA Detector (2), FLR Detector, v1.42 ELS Detector, v Detector, v1.30 Page 7 of 21

8 Waters 2424 ELS Detector Waters HPLC Systems ELS Detector, v Detector, v1.30 Waters 2489 UV/Visible Detector Waters HPLC Systems Detector, v Detector, v1.41 Waters 2998 PDA Detector Waters HPLC Systems Detector, v1.30 SQ Detector All UPLC systems Waters SQ Detector, v1.41 TQ Detector All UPLC systems Waters TQ Detector, v Detector, v1.41 N/A N/A Other system modules Modules Compatible Systems Part Number Software Version Firmware Version Sample Organizer ACQUITY UPLC Systems ACQUITY UPLC 30-cm Column Heater/Cooler ACQUITY UPLC CH-30A ACQUITY UPLC I-Class / ACQUITY UPLC H-Class and H-Class Bio Systems Column Manager Auxiliary Units Local Console Controller SM, or SM-FTN, or SM-FL, All UPLC Systems N/A N/A ACQUITY UPLC H-Class and H-Class Bio Systems N/A N/A N/A N/A All UPLC systems Included with all Driver Pack 4 instrument drivers Sample Organizer, N/A Page 8 of 21

9 Supported Waters and third-party The table below shows which Waters and third-party operate with ACQUITY UPLC systems. System Empower 2: base release to SP H Hotfix 1 ACQUITY UPLC System (including 2D) ACQUITY UPLC H-Class System (including 2D) ACQUITY UPLC H-Class Bio System (including 2D) ACQUITY UPLC I-Class System (including 2D) Empower 3: base release to FR2 MassLynx (see list of SCNs, below) Standalone ACQUITY Console Analyst (see note, below) Yes Yes Yes Yes Version Yes Yes Yes Yes Version Yes Yes Yes Yes Version Yes Yes Yes Yes Version See also: Contact the appropriate vendor for compatibility information about other thirdparty control. The following MassLynx SCNs are compatible with this release: SCN 781, SCN 802, SCN 822, SCN 835, SCN 849, SCN 855, SCN 869, SCN 870, SCN 872, SCN 873, SCN 876, SCN 882, SCN 883, SCN 884, SCN 888, and SCN 896. Requirement: If an SQ, TQ, or 3100 detector is part of the system, you must install, at a minimum, Empower 2 Feature Release 4. Note that the Empower 2 System Suitability option is required. Note: Analyst supports 2D, but only with UPLC solvent managers that differ, such as one QSM and one BSM. Page 9 of 21

10 Defects addressed by this release General The table below lists problems that Driver Pack 4 addresses. The change request (SCR) numbers in the left-hand column identify problems that Waters monitors in its change request database. The right-hand column describes changes in Driver Pack 4. The improvements listed below take effect if you install Driver Pack 4 on both the Empower client, and on the LAC/E 32 module. If you install Driver Pack 4 on the Empower client, but run an earlier Driver Pack version on the LAC/E 32 module, some of the improvements do not take effect. SCR number Instrument or Description Console Equilibrations can once again be run in the standalone console with a CM in the system Console Pressure plots are now displayed in the units (psi, bar, kpa) selected by the user, rather than always psi Console When exporting multiple plot channels, the time base for the channels is now synchronized. Previously the time base of each channel could differ slightly, making plot comparison difficult Console The pressure units selected for display in the console now apply only to the current Windows user. Previously the pressure unit selection applied to all Windows users Deployment Manager The Local Console Controller driver can now be upgraded without affecting the BSM or CM instrument drivers Deployment Manager Deployment Manager 24873, Deployment Manager Deployment Manager Deployment Manager Deployment Manager Waters DHCP Server Fully installing the PDA instrument driver while upgrading other drivers no longer causes a blank PDA method editor. The Local Console Controller driver can now be upgraded without affecting the ELS or FLR drivers. The Empower Verify Files utility now displays the correct version number for the ELS instrument driver. The BSM instrument driver no longer corrupts the nanoacquity BSM instrument driver when they are installed on the same computer. The ICS Companion utility now runs correctly after installation on Citrix servers. The Java runtime engine (JRE) is now installed only if Connections INSIGHT is also installed. The Waters DHCP Server is modified to offer DHCP addresses only on the instrument LAN, not all network cards , Solvent Library The solvent library no longer allows multiple solvent aliases of the same name, a practice that can cause it to stop working. Page 10 of 21

11 SCR number Instrument or Column Calculator Multiple instruments Multiple instruments Multiple instruments Multiple instruments 28178, 26840, Multiple instruments Description Japanese version of the Columns Calculator utility correctly shows L/Dp ratio. Warning level alarms, such as Drawing sample rate excessive, no longer cause memory leaks. Systems with five or more instruments no longer cause a "Database error: unable to continue" error in Empower. Statistical data displayed in post-run reports, such as Maximum System Pressure, is now calculated correctly even without enabling a data channel in the associated instrument s method. Previously, when two of the same type of instrument were included in a system (for example, two BSMs) the instrument method for both instruments would display the same values in the method editor, even if the values of one method were changed. Now both instrument methods can have unique values. When the Empower system definition includes multiple instruments of the same type for example, two BSMs their relative precedence now carries through to the console. The BSM listed first in the Empower system definition now consistently appears first in the console tree, and so on. This relative order is most meaningful elsewhere in the console, where a simple numerical suffix, such as the 2 in BSM2, differentiates instruments of the same type. This change pertains only to instruments of the same type. For instruments that differ in type, the precedence rules of the console still apply to the order of the instruments displayed in the console tree. For example, solvent managers come first, followed by sample managers and then detectors. Previously, for systems that include two PDA detectors in previous driver packs, instrument status obtained for just one of the detectors showed identically in both PDA control panels. This defect is corrected. Page 11 of 21

12 Solvent managers SCR number Instrument or Description BSM Previously, the BSM control panel occasionally failed to properly appear on some Empower Enterprise systems. The defect is corrected BSM Previously, the BSM was vulnerable to an erroneous Pump motor lost synchronization error and shutdown when running specific gradients with a 100% composition. The defect is corrected BSM Previously, the BSM would stop priming if there was an associated column change. The defect is corrected BSM Previously, the BSM did not fully stop the solvent flow if you specified doing so when the current flow rate was 0.01 ml/min. You can now fully stop a flow of 0.01 ml/min QSM Previously, the QSM lost its leak detector configuration after a power cycle. The defect is corrected QSM Previously, an error occurred under certain circumstances in the recommended ph range when you used the Auto Blend Plus function. The defect is corrected QSM Previously, curves 1 and 11 appeared in the method editor s graphical gradient representation as curve 6 (linear). The defect is corrected QSM The QSM leak test now properly primes the user-selected solvent, rather than always priming with the A solvent QSM Previously, the QSM might not completely reach a requested ml/min flow rate when slower method flow rate accelerations were specified. The defect is corrected QSM Stop flow buttons on the console and control panel now operate properly when flow is < 0.01 ml/min QSM The QSM to FTN system leak test has been modified to work successfully with larger ( 100 μl) extension loops , QSM Previously, a QSM pump could randomly cause a general failure error, especially with regard to applications in which flow rate or pressure changes rapidly, such as those that require starting and stopping the pump during a column change. The defect is corrected. Page 12 of 21

13 Sample managers SCR number Instrument or Description 24888, SM Previously, the XY mechanism move-needle functionality in the console did not move the needle. The defect is corrected SM, SM-FL Previously, the characterize Needle Seal diagnostic test showed incorrect values after calibration SM, SM-FL Previously, the results of the Calibrate XY and Zp Axes diagnostic test failed to appear in the console s log SM, SM-FL Previously, in Empower, the Run Samples Needle Wash sample queue function failed. The defect is corrected SM, SM-FL, SM- FTN Sample organizer Previously, during diagnostic tests, the sample manager failed to reliably warn of impending mechanical movements. The defect is corrected. SCR number Instrument or Description SO Previously, the sample organizer s LED lights failed to switch off when the door was closed, which could affect light-sensitive samples. The defect is corrected SO Previously, the sample organizer might not be visible in the console. The defect is corrected SO Previously, the shelf position immediately below the transfer location was not accessible in the sample organizer. The defect is corrected SO Error recovery is improved along with users ability to properly reset the sample organizer SO Previously, the sample organizer s configuration could be lost whenever the computer was restarted. Page 13 of 21

14 Column managers SCR number Instrument or Description CM-A The status of the CM-A leak sensor is now properly displayed CM-A Previously an error Preheater temperature sensor hardware fault was possible if the column temperature was set to ~90.0 without first stabilizing at a lower temperature. The defect is corrected CM, CM-A Previously, the ecord injection count and column history data was incorrectly updated in MassLynx open-architecture systems. The defect is corrected CM-A The CM-A s advanced-mode valve timing is improved to allow for more simultaneous valve operations CM Previously, the column history for Column 6 did not appear properly in the console. The defect is corrected CM, CM-A Previously, it was possible for ecord data to be incorrectly written to the device. The defect is corrected CM-A Previously, the console did not always adapt the list of available CM-A diagnostic channels according to supported hardware options or operating mode. The defect is corrected CM-A Previously, column switching errors were possible when transitioning between sample-queue and instrument-method column switching. Page 14 of 21

15 Third party SCR number Instrument or Description Analyst Previously, after loading the June 2011 driver pack, ACQUITY parameter settings appeared in Analyst acquisition methods, on the Software Application Properties tab. The defect is corrected , Analyst Previously, after loading the June 2011 driver pack on Windows 7, 64-bit machine, Analyst was unable to load plates. The defect is corrected Analyst System correctly collects data after a disabling or enabling the hardware profile. You must run StopProcesses before enabling a hardware profile Analyst Configuring the module in the console correctly updates ACQUITY method editor. Rebooting is required Analyst Column switching causes brief, expected flow delay in I-Class system under Analyst control Analyst ACQUITY AAO Service automatically restarts when the service stops working. The primary purpose of this improvement is to support StopAcquityProcesses and StopProcesses Analyst In mixed security mode, you can reliably log off and log back on. In integrated security mode, you cannot log off the computer while a batch is running. Detectors SCR number Instrument or Description PDA A small PDA memory leak that could cause problems if allowed to accumulate over thousands of injections is eliminated TUV Improved error detection and management of interrupted communications, which could have resulted in an unexpected change in data rate PDA Improved PDA error detection to guard against possible data overruns, should communications to the PDA be interrupted for an extended period of time PDA Channel name and description for MaxPlot and other complex, calculated channels, such as sum, difference, and ratio, are improved to show proper values and ranges. Page 15 of 21

16 SCR number Instrument or Description TUV Previously, a possible error involving the TUV method editor permitted saving a corrupt method, which can produce an incorrect data rate on the second channel. The defect is corrected Previously, the 2998 detector experienced data saturation or produced an incorrect auto exposure when next-injection delays exceed a duration of ten minutes. The defect is corrected PDA The PDA exposure calculation has been corrected to account for timed event wavelength changes to spectral regions of higher energy. Previously, it was possible for an incorrect exposure time to be calculated and executed, which could result in peak area discrepancies TUV Previously, the leak sensors in some older-model TUVs failed to function. The defect is corrected TUV Shutter idle configuration is correctly refreshed, and accurately shows current state PDA Previously, the 2998 server sometimes stopped working on startup or during resets of the server while under the control of MassLynx. The defect is corrected PDA Internal fans operate reliably when the detector is powered up in Maximum cooling mode , PDA Previously, under some circumstances, changing the PDA lamp could cause the console to stop working. The defect is corrected , PDA, TUV Improved PDA and TUV lamp and flow-cell ID communications, to reduce the likelihood of false identification failures , 28273, 28279, PDA, TUV Previously, when you changed a lamp, its memory device sometimes recorded incorrect data (hours, date, and time). The defect is corrected. Page 16 of 21

17 Known issues in this release The table below lists known issues in Driver Pack 4. Waters change request database uses the change request (SCR) numbers in the left-hand column to track these issues. SCR number Instruments or Description s SO If, in the console, you disable the Z-motor and then move the Z-axis manually, the device begins to beep and flash its frontpanel LED. Workaround: To recover, reset the device detector It is possible that the 2489 can experience a filter initialization failure in high temperature and humidity environments when calibrating. Workaround: Filter initialization under varying temperature and humidity conditions is optimized. If filter initialization fails, reboot the instrument to retry the initialization Analyst To ensure successful data acquisition, Analyst control requires methods to specify the same data rate Deployment Manager Occasionally the ICSCompanion service is not installed during normal installation. Workaround: Using the Deployment Manager, perform a typical removal, reboot the computer, and then perform the installation again Console After you specify which instruments will appear in the console, the method editor displays the previously specified instruments. Workaround: Reboot the computer after changing the instrument configuration in the console TUV The TUV s rear-panel switch output, or outputs, can momentarily pulse with each method setup on each injection, causing an extra valve movement if the outputs are used to control external valves Waters Pump Control It is possible that using the Windows Control Panel to uninstall Waters Pump Control released prior to Driver Pack 4 does not remove all files. Workaround: Uninstall Waters Pump Control using the Driver Pack 4 Deployment Manager. Page 17 of 21

18 SCR number Instruments or s Local Console Controller (LCC), ELS, FLR Description During an upgrade from the 1.40 Driver Pack, if the Local Console Controller is being upgraded, the ELS and FLR detectors must be upgraded as well, to avoid failures of the ELS and FLR instrument drivers CM The Column Manager page in the console can sometimes display the message "No Function Text" Verify Instrument Driver Files Workaround: Ignore the message. If the Windows User Account Control (UAC) function is enabled, you must be logged in as an administrator to run the Verify Instrument Driver Files utility Console Closing the console after initiating the System Startup function cancels the function and resets the system modules. Workaround: Do not close the console until the System Startup function is completed Autoloader The Autoloader can sometimes attempt to load BSM firmware on the nanobsm device Deployment Manager Workaround: Power-off all connected nanoacquity modules before beginning an installation. Installing older instrument drivers can occasionally cause deletion of the Empower Verify Files checksumshell.bat file. Workaround: During installation and removal, the Deployment Manager creates a backup of checksumshell.bat in the C:\Empower\Instruments\Logs folder. If checksumshell.bat is deleted, it can be restored from that location to C:\Empower SM-FL Clearing the Disable Motors option in the console does not re-enable motors. Workaround: Reset the instrument via the console to reenable the motors FLR Aborting FLR diagnostic tests sometimes prevents them from being rerun. Workaround: Reboot instrument Waters Pump Control Waters Pump Control (WPC) 3.10 is not compatible with nanoacquity Workaround: If you run nanoacquity along with Driver Pack 4, choose a Custom installation in the Deployment Manager, and then deselect WPC 3.10 before you install. Page 18 of 21

19 SCR number Instruments or Description s ELS, FLR, RI, 2998 Although other Driver Pack 4 instruments support networks with latencies as high as 300 milliseconds, in some cases the ELS, FLR, RI, and 2998 do not. Performance will therefore vary SM Resuming an Empower sample set after an SM error can result in the erroneous message Waiting for injection. Workaround: Abort and restart sample set Verify Files The Verify Instrument Driver Files utility can display script errors with Internet Explorer 8 installed. Workaround: Install Microsoft hotfix KB Connection INSIGHT When you upgrade from the June 2011 Driver Pack to Driver Pack 4 on Windows 7, Connections INSIGHT installation fails occasionally. Workaround: Remove Connections INSIGHT, reboot the computer, install Connections INSIGHT D system In a MassLynx system using 515(s) with a PCM, it can be necessary to reboot the computer after changing the MassLynx instrument configuration Autoloader The Autoloader can stop working if run on a LAC/E 32 module connected to an e2695 separations module. Workaround: Reboot a LAC/E 32 module connected to an e2695 separations module before running the Autoloader QSM The QSM instrument driver must be upgraded when upgrading other instrument drivers to Driver Pack 4, otherwise the Auto Blend Plus feature, specified in the method editor, will stop working. Page 19 of 21

20 Anti-virus considerations If you are using real-time virus scanning, exclude the data system and instruments folders and sub-folders as shown below. Some real-time virus scanners can mistake normal data acquisition and instrument control for virus activity and thus interfere with proper operations. Full-system scans and live updates can be network-intensive, disk-intensive, and CPU-intensive, and they can also interfere with normal data acquisition. Schedule scans and updates for idle times when data acquisition does not occur. Exclude these folders: For Empower 2 and Empower 3 installations, the Empower installation folder, usually C:\Empower, and its sub-folders. For MassLynx installations, C:\Program Files\Waters Instruments, and its sub-folders ( C:\Program Files (x86)\waters Instruments on 64-bit machines). the MassLynx installation folder, usually C:\Masslynx, and its subfolders. For standalone console and other third party installations, C:\Program Files\Waters Instruments, and its sub-folders ( C:\Program Files (x86)\waters Instruments on 64-bit machines). Certain anti-virus program features like "intrusion prevention" and "tamper protection" can also interfere with normal operation. Disable them as well. Requalification guidelines Driver Pack 4 includes instrument driver and firmware used on your laboratory instruments, servers, and workstations. As with any change in a regulated environment, follow your organization's standard operating procedures for managing changes. This update has been designed not to alter the physical specifications of the instrument(s) or system(s), and Waters believes that methods run and data generated on instruments before and after the update will be identical. However, after a risk based review of the changes detailed in the release notes, users in a regulated environment may need to consider and document what, if any, requalification of the instrument modules, the chromatographic system, and/or the Chromatographic Data System (CDS) are required by their own change control SOPs. Use the appropriate qualification methods outlined below to verify installation and correct operation: To confirm that the driver pack installation has not negatively affected any critical system functions, and that the new files have loaded properly, you may consider performing a Installation Qualification (IQ). To confirm the firmware files installed on the modules are correctly installed, compare the checksum values in the product release notes to the checksum values displayed in the console. To confirm an instrument's operation with the newly loaded driver and firmware, you may consider performing an Operational Qualification (OQ) for the updated instrument or system. To confirm performance, control, and communications of the instruments in your system, you should consider conducting a Performance Qualification (PQ) (user or vendor PQ) or System Suitability test. Page 20 of 21

21 Where multiple identical systems are involved, a risk based approach to qualification activities may be an important consideration. Requalifying the instrument driver, firmware, and hardware when upgrading is covered under the Total Assurance Plan with System Qualification Option in the following cases: During yearly requalification under the plan. If loading this release is required for operation of a new module or system, where qualification of the new module or system is covered under the plan. Requalification of the CDS and computers after a driver upgrade may or may not be included in Assurance Plans from the CDS vendor. Review your Total Assurance Plan to determine which services are covered, and which are not covered. For situations not covered under the plan, Waters can still perform the qualification, but additional charges apply. Contact Waters Technical Service If you are located in the USA or Canada, report malfunctions or other problems to Waters Technical Service ( ). If you are located elsewhere, phone the Waters corporate headquarters in Milford, Massachusetts (USA), or contact your local Waters subsidiary. Our Web site includes phone numbers and addresses for Waters locations worldwide. Page 21 of 21