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VK 7025 Op Man 70-9033 Rev G

1. Your printer is now configured correctly Varian Inc Revision G 01 06 VK 7025 Dissolution Apparatus Page 113 P N 70 9033 Operator s Manual Maintenance and Troubleshooting Fuse Replacement Warning The dissolution apparatus contains electrical circuits devices and components operating at dangerous voltages Contact with these circuits devices and components can cause death serious injury or painful electric shock Panels or covers that are retained by fasteners which require the use of a tool for removal may be opened only by Varian trained Varian qualified or Varian authorized service engineers The fuse is located in the power entry module on the rear of the heater circulator Step 1 Before checking or attempting to replace a fuse remove the power cord from the heater circulator Step 2 There is a release slot on the bottom of the fuse compartment The fuse compartment holder is released by inserting a small screw driver beneath the slot Step 3 A slight application of pressure upward releases the compartment Step 4 Pull the fuse compartment holder out of the power entry module The fuse and a spare are located inside The fuse is a 10 amp metric 5 x 20 mm fuse for 115 V and 5 amp metric 5 x 20 mm fuse for 230 V Step 5 Replace the fuse in the compartment Warning Never replace a fuse with one of a higher amperage rating Doing so may compromise the safety marg
2. Manual Sampling of Temperature From the Manual Operation screen select MANUAL SAMPLE The Manual Sampling screen displays MANUAL SAMPLING UP SELECT ALL DOWN UP INDIVIDUAL PROBE DOWN SELECT POSITION 1 VESSEL TEMPS 1 UP 2 UP 3 UP 4 UP 5 UP 6 UP 7 UP 8 UP The vessel temperatures cannula positions display only if temp display is enabled see Temp Display on page 46 To check the temperature in all vessels select DOWN corresponding to SELECT ALL The cannulas lower and the temperature readings display next to all vessel position numbers at the bottom of the screen Wait one minute for the readings to stabilize To raise all probes select UP corresponding to SELECT ALL To check the temperature in a specific vessel location enter the vessel position number and select DOWN corresponding to INDIVIDUAL PROBE The temperature reading displays next to the appropriate vessel position number Wait one minute for the reading to stabilize To raise the individual probe select UP corresponding to INDIVIDUAL PROBE Press ESC to return to the Manual Operation screen Varian Inc Page 64 Operation VK 7025 Dissolution Apparatus Revision G 01 06 Operator s Manual P N 70 9033 Starting a Test Before starting the test complete the following steps to set the DDM manual override adapters in place at vessel positions 7 and 8 Step 1 Step 2 Step 3 Step 4 Step 5 Step 6 Step 7
3. Security Levels ADMINISTRATOR Allows access to all functions SUPERVISOR Allows method editor privileges Does not allow access to the System Setup Menu 1 screen which includes administration and calibration functions OPERATE ONLY Allows access to user functions Does not allow access to the System Setup Menu 1 screen which includes administration and calibration functions Does not allow method editor privileges Up to 24 user identifications and passwords can be stored on the VK 7020 7020 S 7025 User identifications are alphabetic and or numeric combinations no longer than nine characters in length Passwords are numeric and no longer than eight characters in length Note a a If you erase or forget all system administrator passwords contact the Dissolution Systems Service Department Varian Inc Revision G 01 06 VK 7025 Dissolution Apparatus Page 41 P N 70 9033 Operator s Manual Setup Setting Up the User List For initial set up of user identifications and passwords the preprogrammed user identification is 9 and the preprogrammed password is 9 It is recommended that you immediately change the user identification and password for Administrative control of the VK 7025 Dissolution Apparatus once your unit is installed To set up the user list complete the following steps Step 1 Ensure the dissolution apparatus is turned on Step 2 If directed press DRIVE UP to in
4. From the System Setup Menu 1 screen select DIAGNOSTICS The Diagnostic Menu screen displays Select DDM TEST Position a DDM manual override adapter over the DDM at vessel position 7 Do not press down on the adapter Select the corresponding location and the appropriate DDM opens Gentle downward pressure slides the adapter into place The adapter prevents the DDM from closing Repeat steps 3 and 4 for vessel position 8 Press ESC until the Main Menu displays Select MANUAL OPERATION The Manual Operation screen displays When all parameters listed on the Manual Operation screen have been entered and the DDM manual override adapters are in place for vessel positions 7 and 8 complete the steps listed under the appropriate apparatus on the following pages to start the test immediately Apparatus Procedures Paddles See Paddles on page 65 Baskets See Baskets on page 67 Paddle over disk See Paddle Over Disk on page 69 Rotating cylinder See Rotating Cylinder on page 70 Varian Inc Revision G 01 06 VK 7025 Dissolution Apparatus Page 65 P N 70 9033 Operator s Manual Operation Paddles Note If performing a staggered drop remove the cannula assemblies if Ee applicable to prevent the raised paddles from damaging them Before starting the test ensure the paddle spin is enabled or disabled depending on your configuration see Paddle Spin o
5. V vessel installation 28 106 vessel plate layout 43 vessel temperature start 83 volume setting 61 86 Ww warranty 117 warranty limitations 118 water bath care 101 weekly maintenance 98 Varian Inc Index This page was intentionally left blank except for this message Varian Inc Tell Us How We Are Doing We listen to our customers We work hard to make our technical documentation user friendly and to make the information in our manuals easy to retrieve and use We d like you to tell us the kinds of additional information you d find helpful in our documentation Your feedback will be carefully considered when we prepare future editions of this manual This manual should contain the following additional information The most useful thing about this book is This manual would be more helpful if My general impressions of this book are May we contact you regarding your comments YES NO If yes please write your name address and telephone number here Please return this form via mail to Technical Writing Dissolution Systems Varian Inc 13000 Weston Parkway Cary North Carolina 27513 2250 USA Optionally you can return this form via fax at 1 919 677 1550 Always feel free to telephone us to discuss your comments at 1 800 229 1108 VK 7025 Dissolution Apparatus Operator s Manual P N 70 9033 Revision G
6. Enter the method number and press ENTER The method name displays next to METHOD If no method exists see Creating Modify Method on page 84 to create a method List Methods Use this option to display a list of the methods stored on the VK 7025 in order to select a specific method To list the currently available methods by number and name select LIST METHODS The Select Method to Load screen displays Scroll up or down the list by selecting NEXT or PREVIOUS When the correct method is highlighted select SELECT The Start Method screen displays with the new method number and name in place If no method exists see Creating Modify Method on page 84 to create a method Varian Inc Page 74 VK 7025 Dissolution Apparatus Revision G 01 06 Operation Operator s Manual P N 70 9033 Option Response Print Method Lot Batch Data Use this option to print the method parameters To print the information stored under the method number displayed on the Start Method screen select PRINT METHOD The printer must be turned on and enabled To enable the Report Center Printer see Print Reports on page 90 To enter information about the product being tested select LOT BATCH DATA The Lot Batch Data Menu 1 screen displays The following options are listed Product Name Lot Number Batch Number Note and Menu 2 which displays Ref Number and Strength Select the parame
7. 01 06 Service and Warranty Operator s Manual P N 70 9033 This page was intentionally left blank except for this message Varian Inc Index a acrylic care 101 administration screen 47 administrative control 40 administrator operation 45 apparatus selecting 61 b basket care 100 basket height setting 30 basket shaft care 99 basket shaft installation 30 bath vessel difference 48 c calibration calendar 53 calibration menu screen 48 cannula height calibration 50 cartridge ribbon 107 centering vessels 28 cleaning the cannulas 103 clear key 18 clock functions screen 56 comm port functions 56 conventions 17 copying methods 89 d delay start 74 82 delayed heating setting 72 deleting user ids 42 diagnostic menu 54 drive down key 18 drive up key 18 e enter key 18 esc key 18 exclusions 118 exclusive remedies 119 f fiber optic assembly 94 fiber optics installation 93 filling the water bath 27 Varian Inc Index final sample vessel temp 88 final spin rom 88 fuse replacement 113 h hazards 9 l initial sample vessel temp 88 installing fiber optics 93 installing paddle basket shafts 28 installing the printer cartridge ribbon 107 installing vessels 28 instant start 75 introduction 15 k key guide 18 l leaking fittings repairing 102 limitations 118 list methods 73 lot batch data 74 m main menu 59 maintenance 97 manual oper
8. is performed See Vessel Temp Start on page 83 When all appropriate parameters on the Calibration Menu screen have been entered press ESC to return to the System Setup Menu 1 screen Setting an Alternate Drive Unit Position When performing a staggered start and sampling manually with Apparatus 1 you must set an alternate drive unit start position Note gt Ensure the basket assemblies are installed and the standard evaporation covers are removed prior to beginning this procedure To set the height to an alternate position complete the following steps Step 1 From the System Setup Menu 1 screen select CALIBRATION The Calibration Menu screen displays Step 2 Raise the drive unit to its home position Step 3 If applicable remove the cannula assembly Step 4 Raise the basket shafts so the basket shaft heads rest against the spindle housings see Figure 12 Spindle Housing on page 50 Varian Inc Page 50 VK 7025 Dissolution Apparatus Revision G 01 06 Administrator Operation Operator s Manual P N 70 9033 FIGURE 12 Spindle Housing ab het spindle housing Step 5 Ensure the optional basket evaporation covers are in place Step 6 Lower the drive unit to position the baskets just above the evaporation covers Step 7 Select SET ALTERNATE START DRIVE POSITION to set the height The drive unit automatically lowers to this position when a staggered st
9. PRESS RUN TO CONTINUE displays If paddle spin is enabled METHOD STARTUP STATUS MANUAL DISK DROP PRESS STOP TO STOP PADDLES PRESS RUN TO CONTINUE displays Step 2 If paddle spin is enabled press STOP If paddle spin is disabled skip this step and continue to step 3 Step 3 Pull up the shaft locking ring to lift each paddle out of the medium Step 4 Lift the evaporation cover at vessel position 1 manually drop the disk assembly into the vessel and push down the paddle shaft Note In order to drop the disk assembly it may be necessary to raise d gt thedrive unit Press DRIVE UP to raise the drive unit slightly lift each vessel evaporation cover drop the disk assembly into each vessel and press DRIVE DOWN until the drive unit is completely lowered Step 5 Press RUN The Method Status screen displays and the paddles rotate Note I gt To quit the test from the Method Status screen press ESC and select EXIT The Manual Operation screen displays Varian Inc Page 70 VK 7025 Dissolution Apparatus Revision G 01 06 Operation Operator s Manual P N 70 9033 Step 6 At the desired time intervals lift each evaporation cover manually drop the disk assembly into each vessel and push down the corresponding paddle shaft Step 7 Continue the dissolution test according to the prescribed method At the desired time interval pull samples from each vessel Two minutes after the
10. They will be subject to nicks chips and scratches as they bump against each other and they may get bent out of shape Place them back into the original shipping container or other appropriate container between uses This will prevent them from coming into contact with each other or anything else in the storage area Varian Inc Revision G 01 06 VK 7025 Dissolution Apparatus Page 101 P N 70 9033 Operator s Manual Maintenance and Troubleshooting Water Bath Acrylic Care Note IE The following information pertains to any items in addition to the water bath made of acrylic Caution Do not use cleaning compounds containing ammonia or abrasive cleaners on your water bath The water bath supplied with the VK 7025 Dissolution Apparatus should be maintenance free except for an occasional cleaning If you use a water bath algaecide or clear bath product ensure it is compatible with PETG and acrylic The flow paths in the heater circulator are primarily stainless steel and should tolerate most clear bath formulations Check with the product manufacturer to be sure the product is safe for your water bath 1 All of our water baths are fabricated entirely of commercial grade acrylic When using them with corrosive materials such as hydrochloric acid or media containing salts be sure to rinse them thoroughly with deionized water immediately after each use and dry thoroughly with a soft towel or cloth 2 Do
11. adjustable Turn them counterclockwise with a 3 4 inch open wrench until the bubble in the level is in the center at all four check points Step 8 Lock the feet in place by tightening the nut snugly against the base plate see Figure 3 VK 7025 Foot on page 23 Varian Inc Revision G 01 06 VK 7025 Dissolution Apparatus Page 23 P N 70 9033 Operator s Manual Setup FIGURE 3 VK 7025 Foot Raising and Lowering the Drive Unit Warning Ensure your hands are not in the path of the drive unit as it rises and lowers Note There is a safety mechanism in the bottom of the left side guide rod which keeps the drive unit from lowering improperly If the rods do not line up precisely with the holes in the vessel plate the mechanism engages and the drive unit stops lowering and rises to the home position See Figure 4 Drive Unit Guide Rods on page 24 To raise the drive unit press DRIVE UP The drive unit stops automatically when it reaches the home position To stop the drive unit before it reaches the home position press DRIVE UP again To lower the drive unit ensure the drive unit is latched in the forward most position and press and hold DRIVE DOWN Release the key when the drive unit reaches the desired position The drive unit stops automatically when at the lowest position There is a safety mechanism located in the bottom of the left side guide rod which kee
12. being tested or start the test See Start Method on page 73 Method Editor Select METHOD EDITOR to display options to create modify copy or store a method See Method Editor on page 84 Print Reports Select PRINT REPORTS to print the current method parameters serial numbers or the results from the preceding method set print frequency and turn on or off the printer See Print Reports on page 90 Manual Operation From the Main Menu select MANUAL OPERATION The Manual Operation screen displays Varian Inc Revision G 01 06 P N 70 9033 VK 7025 Dissolution Apparatus Page 61 Operator s Manual Operation Following is a description of the Manual Operation screen options Note For the following options if you enter a value outside the acceptable range an error message displays indicating appropriate values Option Response RPM Set If a speed setting has previously been entered the setting displays next to RPM SET To change the setting select RPM SET The cursor flashes Enter the desired speed in xx format The acceptable range is 10 to 250 RPM Press or CLEAR to clear unwanted or incorrect entries Press ENTER to accept the speed setting Bath Temperature Set Point If a temperature setting has previously been entered the setting displays next to BATH TEMPERATURE SET POINT To change the setting select BATH TEMPERATU
13. between the two options This selection is necessary only when using Apparatus 1 baskets See Setting an Alternate Drive Unit Position on page 49 Manual Sample See Manual Sampling of Temperature on page 63 Setting Sample Points and Alarms To enable the alarm complete the following steps Step 1 Select SAMPLE POINT ALARM DISABLED changes to ENABLED and TIME MM SS displays Step 2 Enter the time and press ENTER SAMPLE POINTS displays Press lt to clear unwanted or incorrect entries Step 3 Select SAMPLE POINTS The Sample Points screen displays Step 4 Enter up to 24 timepoints in hhh mm ss format and press ENTER to move to the next timepoint location The maximum acceptable value is 999 59 59 Press lt to clear unwanted or incorrect entries Note Set the sample timepoints far enough apart to allow for the operation of the DDMs and cannulas at least three minutes If there is not enough time between sample timepoints the sample timepoint clock counts negative time Step 5 Select PREVIOUS and NEXT to scroll up and down the timepoints Press CLEAR to delete unwanted timepoints Varian Inc Revision G 01 06 VK 7025 Dissolution Apparatus Page 63 P N 70 9033 Operator s Manual Operation Step 6 After all sample timepoints have been entered press ESC to return to the Manual Operation screen En Note Press CLEAR to silence the alarm
14. displays PRINT REPORTS PRINT PRINT SERIAL METHOD NUMBERS PRINT PREVIOUS RESULTS REPORT PRINTER OFF PRINT FREQUENCY 00 00 00 Varian Inc Revision G 01 06 P N 70 9033 VK 7025 Dissolution Apparatus Page 91 Operator s Manual Operation Following is a description of the Print Reports screen options Note C In order to operate any of the printer functions listed the printer must be enabled See Report Printer On Off below Option Response Print Method Select PRINT METHOD to print method parameters Enter a method number and press ENTER Print Previous Results Select PRINT PREVIOUS RESULTS to print the results from the last test run The printer buffer is 8K If you exceed the storage capacity a complete copy of the previous results will not print The printer buffer resets to 0 whenever a new test is started Report Printer On Off Select REPORT PRINTER to toggle between ON and OFF Once this option is set the selection becomes the default In order to use the Report Center Printer this option must be set to ON Print Frequency Select PRINT FREQUENCY to enter the time interval the current program information should be sent to the Report Center Printer in hh mm ss format Do not enter 00 00 00 to turn off the printer function See Report Printer On Off above Print Serial Numbers Select PRINT SERIAL NUMBERS to pr
15. inhibits the growth of organisms and evaporation by allowing the water bath to be heated only when necessary rather than continuously Step 3 Enter the time in 24 hour format for example 3 00 pm is entered as 15 00 00 Step 4 Press ENTER SET POINT 0 0 displays Step 5 Enter the desired temperature in xx x format The acceptable range is 20 0 to 55 0 C Press or CLEAR to clear unwanted or incorrect entries Press ENTER to accept the temperature setting TIME TO HEATING START displays with a countdown in hh mm ss format Step 6 To stop the delayed heating and reset it to the disabled mode press ESC The Main Menu displays Varian Inc Revision G 01 06 VK 7025 Dissolution Apparatus Page 73 P N 70 9033 Operator s Manual Operation Start Method Note I gt Methods are not write protected Check with other users before proceeding From the Main Menu select START METHOD The Start Method screen displays Following is a description of the Start Method screen options Option Response Select Method Use this option to enter a number between 1 and 23 corresponding to the method desired This is most easily achieved by using List Methods see below If a previous method has been selected the method number displays next to CURRENT and the method name displays next to METHOD If a different method is required select SELECT METHOD The cursor flashes next to CURRENT
16. is available but travel charges may be incurred The customer should prepay all shipping charges for products returned to the Dissolution Systems Service Department unless otherwise authorized and Varian Inc will pay all charges for return to the customer Warranty Limitations Varian Inc makes no other warranty either express or implied with respect to this product Specifically disclaimed are any implied warranties of merchantability and fitness for a particular use In no event will Varian Inc be liable for any indirect incidental or consequential damages arising from the use of this product This warranty gives you specific legal rights which may vary from state to state or province to province so you may have other rights and some of these exclusions may not apply to you Varian Inc Revision G 01 06 VK 7025 Dissolution Apparatus Page 119 P N 70 9033 Operator s Manual Service and Warranty Exclusive Remedies The remedies provided herein are the customer s sole and exclusive remedies In no event shall Varian Inc or its representatives be liable for any direct indirect special incidental or consequential damages whether based on contract tort or any other legal theory Some states or provinces do not allow the exclusion or limitation of incidental or consequential damages so the above limitation or exclusion may not apply to you Varian Inc Page 120 VK 7025 Dissolution Apparatus Revision G
17. is primed and water is flowing Temperature board error HEATER SENSOR OPEN Ensure the cable from the heater circulator to the back of the VK 7025 is connected Temperature board error BATH SENSOR OPEN Ensure the bath temperature probe is plugged into the back of the VK 7025 Temperature board error HEATER SENSOR OVER 70 Check the bath water level Ensure the heater circulator is primed and water is flowing Varian Inc Page 115 VK 7025 Dissolution Apparatus Maintenance and Troubleshooting Revision G 01 06 Operator s Manual P N 70 9033 If any of the listed problems persist contact the Dissolution Systems Service Department The Dissolution Systems Service Department can be reached at 800 229 1108 inside the US or 919 677 1108 outside the US Optionally you can send a fax to 919 677 1138 You can also e mail the Dissolution Systems Service Department at dissolution service varianinc com Varian Inc Page 116 VK 7025 Dissolution Apparatus Revision G 01 06 Maintenance and Troubleshooting Operator s Manual P N 70 9033 This page was intentionally left blank except for this message Varian Inc Chapter 8 Service and Warranty The warranty is provided by Varian Inc or one of its authorized representatives Service and Warranty Information Varian dissolution products carry a one year warranty on parts and labor The Dissolution Systems Service De
18. numbers for the remaining appropriate accessories Press ESC to return to the System Setup Menu 2 screen When all appropriate parameters on the System Setup Menu 2 screen have been entered press ESC to return to the System Setup Menu 1 screen Varian Inc Chapter 5 Oper a ti on Main Menu From the System Setup Menu 1 screen select Main Menu The Main Menu displays MAIN MENU MANUAL START OPERATION METHOD BATH TEMPERATURE METHOD SET POINT 37 5 EDITOR DELAYED PRINT HEATING REPORTS RPM 000 0 BATH 37 2 1 UP 2 UP 3 UP 4 UP 5 UP 6 UP 7 UP 8 UP WED DEC 3 08 32 42 2003 Varian Inc Page 60 Operation VK 7025 Dissolution Apparatus Revision G 01 06 Operator s Manual P N 70 9033 Following is a description of the Main Menu options Option Response Manual Operation Select MANUAL OPERATION to set parameters for manual operation See Manual Operation below Bath Temperature Set Point Select BATH TEMPERATURE SET POINT The cursor flashes Enter the desired bath temperature and press ENTER Note use this option to heat the bath independent of running a program or performing manual operation Delayed Heating Select DELAYED HEATING to enter date time and temperature for heating to begin See Setting Delayed Heating on page 72 Start Method Select START METHOD to select the method to run print the method parameters enter information about the product
19. page 87 to enable the DDM Test Length Select TEST LENGTH to set the desired test length The cursor flashes Enter the desired test length in hhh mm ss format and press ENTER The maximum acceptable input is 999 59 59 Press lt to clear incorrect or unwanted entries Menu 2 After the appropriate parameters have been entered on Method Menu 1 select MENU 2 The Method Menu 2 displays See page 88 for information on Method Menu 2 Sampling Setup To set the sample timepoints select SAMPLING SETUP from the Method Menu 1 screen The Sampling Setup screen displays Following is a description of the Sampling Setup screen options Option Response Auto Sampling Select AUTO SAMPLING to toggle between ENABLED and DISABLED If an autosampler is installed ensure ENABLED displays next to the option If DISABLED displays on the screen select DISABLED to enable this option Once autosampling is enabled you are prompted to enter the cannula downtime See Set Cannula Down Time and AutoTemp below Set Cannula Select SET CANNULA DOWN TIME to enter the amount of time the Down Time cannula remains in the vessel The cursor flashes Enter a time in mm ss format and press ENTER The minimum acceptable time is one minute AutoTemp Select AUTOTEMP to toggle between ENABLED and DISABLED if installed AutoTemp must be enabled to measure vessel temperatures Varian Inc Page 86 VK 7025 Dissolution Apparatus
20. the Waters Alliance System The external start command is supplied as a simple TTL closure through a four pin DIN cable supplied separately connected to the START INPUT port located on the rear panel of the VK 7025 Select WAIT EXTERNAL START WAITING EXTERNAL START displays The test runs according to the program entered on the VK 7025 once the external start command is received Instant Start Depending upon the apparatus listed in the method and the options installed on your tester complete the steps listed under the appropriate apparatus on the following pages to start the test immediately Apparatus Procedures Paddles See Paddles on page 76 Baskets See Baskets on page 78 Paddle over disk See Paddle Over Disk on page 79 Rotating cylinder See Rotating Cylinder on page 80 Varian Inc Page 76 VK 7025 Dissolution Apparatus Revision G 01 06 Operation Operator s Manual P N 70 9033 Paddles Note Before starting the test ensure DDM is enabled or disabled see Controlling Dosage Delivery Module VK 7025 with Paddles I gt only on page 87 paddle spin is enabled or disabled see Paddle Spin on page 46 and initial and final temp are enabled or disabled see Sample Vessel Temp on page 88 depending on your configuration Step 1 From the Start Method screen select INSTANT START Paddle Initial Final After select
21. the shafts taking care not to drop them into the vessels Varian Inc VK 7025 Dissolution Apparatus Revision G 01 06 Page 34 Operator s Manual P N 70 9033 Setup Centering Verification To verify the centering of the paddle basket shafts complete the following steps Step 1 Locate the centering verification gauge and the EaseAlign centering ring FIGURE 6 Centering Verification Gauge radial cutout FIGURE 7 EaseAlign Centering Ring Step 2 Place the EaseAlign centering ring on the first vessel see Figure 7 EaseAlign Centering Ring above Step 3 Place the centering verification gauge against the shaft with the shaft resting in the radial cutout see Figure 6 Centering Verification Gauge above Varian Inc Revision G 01 06 VK 7025 Dissolution Apparatus Page 35 P N 70 9033 Operator s Manual Setup Step 4 Slide the centering verification gauge down the shaft until the tapered ends rest in two opposing slots of the EaseAlign centering ring Step 5 Rotate the centering verification gauge 90 degrees and slide the gauge down the shaft until the tapered ends rest in the other two opposing slots of the EaseAlign centering ring The shaft should remain within the confines of the radial cutout of the gauge at both settings Step 6 Repeat steps 2 5 for the remaining vessel positions Installing Cannula Assemblies Step 1 Step 2 Step 3 Ensure the sampling a
22. 0 9033 Operator s Manual Setup Step 3 Press and hold DRIVE DOWN until the drive unit is at its lowest position Note There is a safety mechanism in the bottom of the left side guide rod which keeps the drive unit from lowering improperly If the I gt rods do not line up precisely with the holes in the vessel plate the mechanism engages and the drive unit stops lowering and rises to the home position See Figure 4 Drive Unit Guide Rods on page 24 Step 4 Gently press down the shaft until the desired height is reached Step 5 Place a shaft locking ring on the top of the shaft and slide it down until it rests on the shaft collar Step 6 Rotate the shaft locking ring so the drive positioning teeth on both the shaft locking ring and the shaft collar rest against one another locking Tighten the set screw using the 7 64 inch T handle Allen wrench provided The intrinsic dissolution apparatus is set at the desired height above the bottom of the vessel Step 7 Repeat this procedure as applicable for additional positions Removing the Dissolution Apparatus To remove paddles baskets rotating cylinders or intrinsic dissolution apparatus complete the following steps Step 1 Loosen the set screw on the shaft locking ring using the 7 64 inch T handle Allen wrench and remove the shaft locking ring Repeat this step for all positions Step 2 Raise the drive unit to its home position and gently remove
23. 25 Dissolution Apparatus Revision G 01 06 Maintenance and Troubleshooting Operator s Manual P N 70 9033 Step 2 Remove the cannulas from the dissolution apparatus by pulling up the entire cannula assembly housing which contains the cannulas and if applicable the thermistor Step 3 Disconnect the cannulas from the sample tubing Step 4 Remove the sample cannulas from the cannula assembly and clean using an appropriate cleaning solution Step 5 Wipe any surface discoloration from the cannula assembly housings with a clean damp cloth Step 6 Carefully place the sample cannulas back into the cannula assemblies Step 7 Reconnect the sample tubing Step 8 Use the guide pin and coordinating notch to position the cannula assembly housing and reinsert it into the top cover of the dissolution apparatus Push the cannula down until it engages with the gears in the motor housing Step 9 Turn on the dissolution apparatus The cannulas return to the home position Cleaning the Cannulas Using the VK 8000 Clean System Function Step 1 Step 2 Step 3 Ensure the VK 7020 S 7025 is connected correctly to the VK 8000 and that external control is enabled See External Control on page 56 Ensure the drive unit is raised to the home position Ensure the baskets or paddles are out of the way of the cleaning solution containers by pushing them up against the spindle housings Varian Inc Revision G 01 06 VK 7025 Dissol
24. C once to return to the Method Status screen and a second time to quit the test Rotating Cylinder Step 1 From the Start Method screen select INSTANT START RAISE DRIVE TO INSTALL PATCHES PRESS RUN TO MOVE DRIVE TO STANDARD START POSITION displays Step 2 Press DRIVE UP to raise the drive unit to the home position Step 3 Install the patches on the rotating cylinders Varian Inc Revision G 01 06 VK 7025 Dissolution Apparatus Page 81 P N 70 9033 Operator s Manual Operation Step 4 Press RUN LOWERING DRIVE displays and the drive unit lowers to the operating position The Method Status screen displays and the cylinders rotate Note I To quit the test from the Method Status screen press ESC and select EXIT The Start Method screen displays Step 5 Continue the dissolution test according to the prescribed method Two minutes after either the cannulas return to the home position or the final keystroke the Test in Progress screen displays Note 7 s To quit the test from the Test in Progress screen press ESC once to return to the Method Status screen and a second time to quit the test For the first two minutes of a test the Method Status screen displays the following information e method name e current time e selected apparatus e current date set speed current speed e set bath temperature e current bath temperature e next
25. IGHT displays Ensure the alternate drive position is set see Setting an Alternate Drive Unit Position on page 49 Step 1 Press RUN RAISE DRIVE TO INSTALL BASKETS PRESS RUN TO MOVE DRIVE TO STANDARD ALTERNATE START POSITION displays Step 2 Press DRIVE UP to raise the drive unit to the home position Step 3 Install the baskets containing the dosage units Step 4 Press RUN If using the standard start height LOWERING DRIVE displays and the drive unit lowers to the operating position If using the alternate start height MOVING DRIVE INTO POSITION displays The drive unit lowers to the previously entered alternate start position Note If using the standard start height and low loss evaporation covers press STOP to stop the drive unit approximately two Q inches above the vessel plate Align the evaporation cover with the cannula assembly and the DDM tube at each vessel position Press DRIVE DOWN to lower the drive unit to the operating position The Method Status screen displays Varian Inc Page 68 VK 7025 Dissolution Apparatus Revision G 01 06 Operation Operator s Manual P N 70 9033 FIGURE 14 Basket Low loss Evaporation Cover Positioning and Sampling Step 5 The Method Status screen displays and the baskets rotate Note IE To quit the test from the Method Status screen press ESC and select EXIT The Manual Operation screen displays
26. ING DRIVE displays and the drive unit lowers If using the standard evaporation covers the drive unit lowers to the operating position The Method Status screen displays and the baskets rotate Note If using the low loss evaporation covers press STOP to stop the drive unit approximately two inches above the vessel plate a Align the evaporation cover with the cannula assembly and the DDM tube at each vessel position Press DRIVE DOWN to lower the drive unit to the operating position The Method Status screen displays To quit the test from the Method Status screen press ESC and select EXIT The Start Method screen displays Varian Inc Revision G 01 06 VK 7025 Dissolution Apparatus Page 79 P N 70 9033 Operator s Manual Operation Step 6 Continue the dissolution test according to the prescribed method Two minutes after either the cannulas return to the home position or the final keystroke the Test in Progress screen displays Note S gt To quit the test from the Test in Progress screen press ESC once f to return to the Method Status screen and a second time to quit the test Paddle Over Disk Note gt Before starting the test ensure paddle spin is enabled or disabled i j see Paddle Spin on page 46 and final temp is enabled or disabled see Sample Vessel Temp on page 88 depending on your configuration Step 1 From
27. JUSTED TO CONTROL VESSEL TEMP INPUT VESSEL START TEMP displays on the screen and the cursor flashes Step 2 Enter a temperature and press ENTER The acceptable range is 20 0 to 55 0 C Step 3 The shafts rotate at 15 RPM and the cannulas lower The following screen displays VESSEL TEMP START STATUS BATH TEMP WILL BE ADJUSTED TO CONTROL VESSEL TEMP WAITING FOR VESSELS TO STABILIZE AT 37 0 TIME SINCE HEATING START 00H 01M 00S RPM 015 0 BATH 037 2 1 37 1 2 36 9 3 37 1 4 37 0 5 37 0 6 36 9 7 36 9 8 37 1 FRI MAY 23 15 23 04 2003 Step 4 To stop the heating process press and hold ESC until the screen goes blank The cannulas return to the home position and the Start Method screen displays Varian Inc Page 84 VK 7025 Dissolution Apparatus Revision G 01 06 Operation Operator s Manual P N 70 9033 Method Editor From the Main Menu select METHOD EDITOR The Method Menu screen displays You can view the method but only those with appropriate security levels can change information in this section The Method Menu screen displays the following options Modify Method see Creating Modify Method below Copy Method see Copying Methods on page 89 and Store Method see Storing Methods on page 90 Creating Modify Method To create a new method or modify an existing method complete the following steps Step 1 From the Method Menu screen select MODIFY METHOD to display the Sele
28. Operator s Manual P N 70 9033 Installing and Centering the Vessels The tester is supplied with specially designed vessels and magnetic ring flanges The magnetic ring flanges will keep the vessels centered at all times without the use of tools and prevent the vessels from floating even when they are empty Step 1 Raise the drive unit to its home position and slide it back until it stops Step 2 Place the vessel in the hole in the vessel plate Press down so that the vessel and magnetic ring flanges fit securely in place and are flush with the vessel plate Step 3 Twist the vessel slightly until the magnets in the ring flanges make contact with the magnets in the vessel plate Step 4 Repeat steps 2 and 3 for each vessel Step 5 The vessels are automatically centered and require no further adjustment Installing Paddle Basket Shafts USP guidelines require that the paddle or basket shaft be aligned with the center vertical axis of the vessel and that the bottom of each paddle or basket be 25 2 mm above the bottom of the vessel See the current USP for a complete explanation Varian Inc Revision G 01 06 VK 7025 Dissolution Apparatus Page 29 P N 70 9033 Operator s Manual Setup Installing Paddles Note If using paddles it is easier to install the evaporation covers aji gt prior to installing the paddles See Installing Standard Evaporation Covers on page 36 or Install
29. POSITION 0 Note ua The factory set number displayed under each option is nota distance measurement It refers to the number of steps the cannula motor moves Varian Inc Page 96 VK 7025 Dissolution Apparatus Revision G 01 06 Fiber Optics Operator s Manual P N 70 9033 Step 14 To ensure the fiber optic probes are in their home position select MOVE DOWN to move the fiber optic probes to their lowest position then select MOVE UP to move the fiber optic probes to their highest position Step 15 Select MOVE UP or MOVE DOWN to position the fiber optic windows at the appropriate height in the vessels See Figure 17 Fiber Optic Probe in Vessel on page 96 FIGURE 17 Fiber Optic Probe in Vessel Step 16 When the fiber optic windows are in the correct position select the appropriate apparatus and volume The number of steps the cannula motor moved to reach that position displays under the selected apparatus and volume Step 17 Press ESC The fiber optic probes return to the home position and the Calibration Menu screen displays Step 18 Press ESC again to return to the System Setup Menu 1 screen Varian Inc chapter7 Maintenance and Troubleshooting Maintenance Warning The dissolution apparatus contains electrical circuits devices and components operating at dangerous voltages Contact with these circuits devices and components can cause death serious injury or pai
30. RE 15 FIGURE 16 FIGURE 17 FIGURE 18 FIGURE 19 Manual Sampling through the Top Cover 39 Vessel Plate Layout 43 Spindle Housing 50 Standard Evaporation Cover Dropping Dosage Unit and Sampling 65 Basket Low loss Evaporation Cover Positioning and Sampling 68 Fiber Optic Assembly 93 Fiber Optic Assembly Setting 94 Fiber Optic Probe in Vessel 96 Cannula Cleaning Tray 105 TruCenter Vessel exploded view 106 Varian Inc chapter1 Safety Practices and Hazards The VK 7025 has been carefully designed so that when used properly you have an accurate fast flexible and safe instrument If the equipment is used in a manner not specified by the manufacturer the protection provided by the equipment may be impaired Operation of a VK 7025 involves the use of aqueous liquids and various pharmaceutical dosage forms Unskilled improper or careless use of this instrument can create shock hazards fire hazards or other hazards which can cause death serious injury to personnel or severe damage to equipment and property Information on safety practices is provided with your instrument and operation manuals Before using your instrument or accessories you must thoroughly read these safety practices Observe all relevant safety practices at all times Varian Inc Page 10 VK 7025 Dissolution Apparatus Revision G 01 06 Safety Practices and Hazards Operator s Manual P N 70 9033 Electrical Hazard
31. RE SET POINT The cursor flashes Enter the desired temperature in xx x format The acceptable range is 20 0 to 55 0 C Press or CLEAR to clear unwanted or incorrect entries Press ENTER to accept the temperature setting Volume If a volume setting has previously been entered the setting displays below VOLUME To change the setting select VOLUME The cursor flashes Enter the media volume in xxxx format The acceptable range is 500 to 1050 Press or CLEAR to clear unwanted or incorrect entries Press ENTER to accept the volume setting Apparatus If an apparatus setting has previously been entered the setting displays below APPARATUS To change the apparatus selection select APPARATUS The Select Apparatus screen displays The options listed include Baskets Paddles Paddle Over Disk and Rotating Cylinder Select the apparatus being used The Manual Operation screen displays and the newly selected apparatus is listed below APPARATUS Varian Inc Page 62 VK 7025 Dissolution Apparatus Revision G 01 06 Operation Operator s Manual P N 70 9033 Option Response Sample Point Alarm The sample point alarm allows the user to set an alarm to sound at some time interval prior to the sample point By default the sample point alarm is disabled See Setting Sample Points and Alarms below Use Alternate Standard Start Height Select ALTERNATE STANDARD START HEIGHT to toggle
32. Revision G 01 06 Operation Operator s Manual P N 70 9033 Option Response Volume Select VOLUME to enter the media volume The cursor flashes Enter a volume and press ENTER The acceptable range is 500 to 1050 mL Sample Points Select SAMPLE POINTS to toggle between ENABLED and DISABLED If enabled SET SAMPLE POINTS and SAMPLE POINT ALARM ENABLED DISABLED display See below Set Sample Points To set the sample timepoints see Setting Sample Points below Sample Point The sample point alarm is disabled by default Alarm To enable the sample point alarm select SAMPLE POINT ALARM DISABLED from the Sampling Setup screen SAMPLE POINT ALARM ENABLED and TIME MM SS display Enter the time interval prior to the sample point for the alarm to sound and press ENTER Press CLEAR to silence the alarm Setting Sample Points Step 1 Select SET SAMPLE POINTS The Sample Points screen displays a list of timepoints 01 through 24 The cursor flashes next to timepoint 01 Step 2 Enter the timepoint in hhh mm ss format and press ENTER to move to the next timepoint location Press lt to clear unwanted or incorrect entries one character at a time Press CLEAR or 0 gt ENTER to delete the current timepoint or any unwanted timepoints Note Set the sample timepoints far enough apart to allow for the operation of the DDMs and cannulas at least three minutes If a there is not enough time between sample timepoi
33. SABLED from the Method Menu 1 screen The DDM Setup Menu screen displays Step 2 Select DOSAGE DELIVERY DISABLED DOSAGE DELIVERY ENABLED and DOSAGE DELIVERY METHOD SIMULTANEOUS display Step 3 To change to sequential select DOSAGE DELIVERY METHOD SIMULTANEOUS DOSAGE DELIVERY METHOD SEQUENTIAL and DELIVERY INCREMENT display If clutches are not installed the paddles rotate during a sequential dosage delivery If clutches are installed the paddle stops for approximately three seconds as the corresponding DDM opens Step 4 Select DELIVERY INCREMENT The cursor flashes Varian Inc Page 88 VK 7025 Dissolution Apparatus Revision G 01 06 Operation Operator s Manual P N 70 9033 Step 5 Enter a delivery increment time in mm ss format and press ENTER The maximum acceptable value is 59 59 Step 6 Press ESC to return to the Method Menu 1 screen When all the appropriate parameters have been entered on the Method Menu 1 screen select MENU 2 The Method Menu 2 screen displays Following is a description of the Method Menu 2 screen options Option Response Final Spin RPM To program a final spin select FINAL SPIN RPM The cursor flashes Enter the desired speed in xxx format The acceptable range is 10 to 250 RPM Press ENTER Press lt to clear unwanted or incorrect entries Final Spin Time Select FINAL SPIN TIME to set the final spin time The cursor flashes Enter the desired spin time in hhh mm ss format and pres
34. Step 6 If using an alternate start height manually press the basket shafts down so the baskets are lowered into the vessel at the desired time intervals Step 7 Continue the dissolution test according to the prescribed method At the desired time interval pull samples from each vessel Two minutes after the final keystroke the Test in Progress screen displays Note For vessel positions 1 6 remove the knobbed evaporation plug pull the sample and replace the knobbed evaporation plug see Figure 14 Basket Low loss Evaporation Cover Positioning and Q Sampling above For vessel positions 7 and 8 place the long cannula part number 17 3315 into the vessel through the opening in the DDM See Setting the Manual Sampling Cannula on page 38 To quit the test from the Test in Progress screen press ESC once to return to the Method Status screen and a second time to quit the test Varian Inc Revision G 01 06 VK 7025 Dissolution Apparatus Page 69 P N 70 9033 Operator s Manual Operation Paddle Over Disk Note If performing a staggered drop remove the cannula assemblies if KK applicable to prevent the raised paddles from damaging them Before starting the test ensure the paddle spin is enabled or disabled depending on your configuration see Paddle Spin on page 46 Step 1 Press RUN If paddle spin is disabled METHOD STARTUP STATUS MANUAL DISK DROP
35. age and replace the fitting as necessary Apply new Teflon tape to the male fitting threads Reinstall and tighten the bulkhead fitting on the water bath Reinstall and tighten the elbow fitting to the bulkhead fitting Fill the water bath and turn on the heater circulator Inspect the fitting for leaks If the fitting still leaks contact the Dissolution Systems Service Department Varian Inc Revision G 01 06 VK 7025 Dissolution Apparatus Page 103 P N 70 9033 Operator s Manual Maintenance and Troubleshooting Removing the Top Cover Caution Panels or covers that are retained by fasteners which require the use of a tool for removal may be opened only by Varian trained Varian qualified or Varian authorized service engineers Step 1 Turn on the dissolution apparatus Step 2 Lower the drive unit to the lowest position Step 3 Turn off the dissolution apparatus and remove the power cord Step 4 Remove the two screws in the top cover located just behind the display screen Step 5 Lift the top cover from the front of the machine It hinges back to allow access to the machinery Replacing the Top Cover Step 1 Pull down the front end of the top cover and rest it in place Step 2 Replace the two screws in the cover behind the display screen Step 3 Reconnect the power cord and turn on the instrument Cleaning the Cannulas Step 1 Turn off the dissolution apparatus Varian Inc Page 104 VK 70
36. ance to a new section of the ribbon by pressing the printer toggle switch to the Paper feed position If the printing is still faint replace the cartridge To install the cartridge Step 1 Toggle the printer off line by pressing the printer toggle switch to the OnLine Off Line position When the printer is off line the Ready LED does not illuminate Varian Inc Page 108 VK 7025 Dissolution Apparatus Revision G 01 06 Maintenance and Troubleshooting Operator s Manual P N 70 9033 Step 2 Step 3 Step 4 Step 5 Step 6 Step 7 Step 8 Four small grooves are embossed on the printer cover Gently push on these grooves to tilt the cover When the printer cover is tilted up you can lift it off completely Push down on the right side of the ribbon cartridge marked PUSH and remove the old cartridge Install the new cartridge If there is already paper in the printer hold the cartridge between your thumb and index finger slide it over the paper and into the printer compartment Ensure the paper is between the ribbon cartridge and the ink ribbon Ensure the ink cartridge is inserted firmly to prevent weak or irregular printing The cartridge must be properly seated and aligned for the best printing Turn the cartridge knob marked by an arrow clockwise to stretch the ribbon taut Replace the cover Toggle the printer online by pressing the printer toggle switch to the OnLine Off Line position T
37. art test is started with Apparatus 1 while under manual operation Step 8 With the drive unit in this position reset the basket height to the USP specified 25 2 mm above the bottom of the vessel When all appropriate parameters on the Calibration Menu screen have been entered press ESC to return to the System Setup Menu 1 screen Cannula Height Calibration Note I gt This section does not apply if you are manually sampling or using staggered baskets or paddles If it is necessary to adjust the factory set sampling heights for the cannulas complete the following steps Step 1 Ensure the drive unit is in its lowest position Varian Inc Revision G 01 06 VK 7025 Dissolution Apparatus Page 51 P N 70 9033 Operator s Manual Administrator Operation Step 2 From the Calibration Menu screen select CANNULA HEIGHT CALIBRATION The Set Sampling Depth screen displays with factory set values for each apparatus SET SAMPLING DEPTH BASKET 900 mL MOVE 200 UP BASKET 500 mL MOVE 400 DOWN PADDLE 900 mL 200 PADDLE 500 mL MENU 2 400 CANNULA POSITION 0 Note Q _ _ The factory set number displayed under each option is nota distance measurement It refers to the number of steps the cannula motor moves Step 3 If you are using paddle over disk or rotating cylinder select MENU 2 to view these apparatus Step 4 To ensure the cannulas are in their home position selec
38. ater whenever possible If you must use a cleanser or solvent be sure that it is as mild as possible non abrasive and fully compatible with fluorocarbons and stainless steel before use If in doubt call the service department for advice before proceeding 3 We recommend that you do not use a laboratory dishwasher Clean paddles and basket shafts only by hand The high temperatures to which your items would be subject in a dishwasher may damage the fluorocarbon coating 4 Be sure to handle with care Our QC laboratory has checked the shafts for straightness to ensure that they will operate without significant wobble If you must clean or handle them while they are still mounted on the instrument use minimal pressure on the shaft to prevent them from bending While in the chucks just a little bit of pressure exerted on the shaft especially near the blade or basket can easily bend the shaft and cause significant wobble 5 Use care when removing vessels from the apparatus while the paddles or basket shafts are installed so that you do not bump them 6 When attaching or removing baskets do not bend the clips excessively 7 Please store paddles and basket shafts properly between uses Do not simply place these items in a drawer They will be subject to nicks chips and scratches as they Varian Inc Page 100 VK 7025 Dissolution Apparatus Revision G 01 06 Maintenance and Troubleshooting Operator s Manual P N 70 9033 bum
39. ation 60 manual operation screen 60 manual sampling screen 63 menu key 18 method editor 84 method menu 1 screen 84 method menu 2 screen 88 method status screen 81 modify method 84 monthly maintenance 98 0 obtaining warranty service 118 operation 59 p paddle care 99 paddle height setting 29 paddle installation 29 print method 74 print reports 90 printer configuration 111 self test 110 toggling online 110 r reader comment form 125 repairing leaking fittings 102 rom set 61 run key 18 S safety practices 9 sample point alarm setting 62 sampling setup 85 sampling temperatures 63 screen saver 18 security levels 40 select method 73 selecting apparatus 61 self test printer 110 service 117 setting alarms 52 setting alternate drive unit position 49 setting basket height 30 setting comm port functions 56 setting delayed heating 72 setting paddle height 29 setting sample points 62 86 setting serial numbers 57 setting speed 61 setting up the heater circulator 25 setting up the vk 7025 22 setting up the water bath 25 setting volume 61 86 setup 19 start method screen 73 starting a test 64 stop pause key 18 store methods 90 system setup menu 1 screen 46 system setup menu 2 screen 55 Varian Inc Index t temp set 61 temperature start 75 83 top cover 103 u unpacking your vk 7025 19 user list 41 user settings 45 using the vk 8000 clean system function 104
40. ator s Manual Setup Filling the Water Bath Step 1 Raise the drive unit to its home position and slide it back to allow full access to the vessels Step 2 If applicable remove one of the vessels and set it aside Fill the water bath with ultrapure water by pouring the water through the hole in the vessel plate Fill to the level indicated by the operating water level tag located on the right side of the water bath Note If possible preheat the water to speed achievement of the o desired bath temperature Use purified water whenever possible I gt to minimize scale and mineral buildup Algaecides may be used to inhibit algae and bacteria growth Check the label to ensure the formulation is compatible with the plastic materials used in the bath construction See Water Bath Acrylic Care on page 101 Step 3 Turn on the heater circulator Step 4 Check all connections for leaks You may notice bubbles from the water bath inlet as the air in the system is purged After a few minutes flow into the bath should be smooth and steady Note Though the heater circulator is designed to be self priming it U gt might be necessary to help the priming process in a dry unit With the unit below the level of the water bath lift one end and then the other for a minute or two to help air clear from the unit Varian Inc Page 28 VK 7025 Dissolution Apparatus Revision G 01 06 Setup
41. ave TAY VK 7025 Dissolution Apparatus Operator s Manual P N 70 9033 January 2006 Revisio Limitation of Liability The information in this document is subject to change without notice Varian Inc makes no warranty of any kind with regard to this material including but not limited to the implied warranties or merchantability and fitness for a particular purpose Varian Inc shall not be liable for errors contained herein or for incidental consequential damages in connection with the furnishing performance or use of this material All rights are reserved Reproduction adaptation or translation without prior written permission is prohibited except as allowed under copyright laws First Edition January 2006 VK 7025 Dissolution Apparatus Operator s Manual Part Number 70 9033 Revision G Printed in the United States of America The following terms are trademarks of Varian Inc e Benchsaver e Practical Solutions BIO DIS III QA and QAII Enhancer Cell e TruCenter Full Flow Filters VanKel Peak Vessel VK Varian Inc 13000 Weston Parkway Cary North Carolina 27513 2250 800 229 1108 919 677 1108 Fax 919 677 1138 www varianinc com ap as VARIAN Copyright c 2002 2006 by Varian Inc Table of Contents Chapter 1 Safety Practices and Hazards 9 Electrical Hazards 10 Other 10 General 13 WEEE Directive 13 Chapter 2 Introduction 15 Conventions U
42. chanism in the bottom of the left side guide rod which keeps the drive unit from lowering improperly If the CN gt rods do not line up precisely with the holes in the vessel plate the mechanism engages and the drive unit stops lowering and rises to the home position See Figure 4 Drive Unit Guide Rods on page 24 Step 4 Step 5 Step 6 Step 7 Step 8 Step 9 Using a height gauge tool optional gently press down the rotating cylinder shaft to set the height to the USP specified height of 25 2 mm above the bottom of the vessel Place a shaft locking ring on the top of the shaft and slide it down until it rests on the shaft collar Rotate the shaft locking ring so the drive positioning teeth on both the shaft locking ring and the shaft collar rest against one another locking the shaft in place Tighten the set screw using the 7 64 inch T handle Allen wrench provided Repeat steps 3 7 for each of the remaining positions Lower the drive unit until it stops The rotating cylinders are set at the USP specified height of 25 2 mm above the bottom of the vessel Installing the Intrinsic Dissolution Apparatus Step 1 Step 2 Raise the drive unit to its home position Carefully insert an intrinsic dissolution apparatus shaft into a spindle until approximately half of the shaft is above the top of the spindle Varian Inc Revision G 01 06 VK 7025 Dissolution Apparatus Page 33 P N 7
43. ck Caution Panels or covers that are retained by fasteners which require the use of a tool for removal may be opened only by Varian trained Varian qualified or Varian authorized service engineers Varian Inc Revision G 01 06 VK 7025 Dissolution Apparatus Page 17 P N 70 9033 Operator s Manual Introduction The following illustration shows a VK 7025 Conventions Used in this Manual e Quick keys you are asked to press are in bold For example press MENU e To perform functions that require making selections from the display screen for example select MANUAL OPERATION means to press the key to the left or right of MANUAL OPERATION e Key sequences you are asked to press appear like this 0 gt ENTER Note Remember to return the warranty card supplied with this manual Completing and returning the card ensures your right to dE protection under the terms and conditions of your warranty It also enables us to better assist you in the event of any problems Additionally it guarantees you will be informed of any issues that arise concerning your equipment such as upgrades retrofits or regulatory changes Varian Inc Page 18 VK 7025 Dissolution Apparatus Revision G 01 06 Introduction Operator s Manual P N 70 9033 Quick Key Guide ESC Press ESC to return to the previous screen MENU From any point after the Main Menu pre
44. ct Method Location to Modify screen Step 2 Scroll up or down the list by selecting NEXT or PREVIOUS until the correct method number is highlighted Step 3 Select SELECT If no method exists scroll through the list until the desired method location is highlighted and select SELECT The Method Menu 1 screen displays Following is a description of the Method Menu 1 screen options Option Response Method Select METHOD to name the method The cursor flashes Enter the desired name and press ENTER The method name displays Apparatus Select APPARATUS to change the apparatus being used for the test See Apparatus on page 61 RPM Set Select RPM SET to set the speed in rotations per minute See RPM Set on page 61 Bath Temperature Select BATH TEMPERATURE SET POINT to set the water bath Set Point temperature in degrees Celsius See Bath Temperature Set Point on page 61 Varian Inc Revision G 01 06 VK 7025 Dissolution Apparatus Page 85 P N 70 9033 Operator s Manual Operation Option Response Sampling Setup Use this option to enable or disable autosampling and set cannula down time AutoTemp volume sample points and sample point alarms See Sampling Setup below DDM Disabled if This option indicates the status of the dosage delivery module DDM installed is disabled by default See Controlling Dosage Delivery Module VK 7025 with Paddles only on
45. dapter into place The adapter prevents the DDM from closing Press ESC twice to return to the System Setup Menu 1 screen Attach the cannula part number 17 3315 to the syringe Place the manual sampling cannula through the DDM manual override adapter and into the vessel see Figure 10 Manual Sampling through the Top Cover on page 39 Varian Inc Revision G 01 06 VK 7025 Dissolution Apparatus Page 39 P N 70 9033 Operator s Manual Setup FIGURE 10 Manual Sampling through the Top Cover cannula bushing Step 8 Loosen the hex screw on the cannula bushing and slide the bushing up or down the cannula until it is positioned for the correct USP specified sampling location Step 9 If sampling from a 500 mL volume remove the bushing Step 10 When positioned correctly tighten the hex screw Step 11 Remove the manual sampling cannula and set aside for use during the test Step 12 Gently remove the DDM manual override adapter Varian Inc Page 40 VK 7025 Dissolution Apparatus Revision G 01 06 Setup Operator s Manual P N 70 9033 Programming Administrative Control Note For initial setup the preprogrammed user identification is 9 and a gt the preprogrammed password is 9 It is recommended that you immediately change the user identification and password for Administrative control of the VK 7020 7020 S 7025 Dissolution Apparatus once your unit is operational
46. e shaft collar Step 7 Rotate the shaft locking ring so the drive positioning teeth on both the shaft locking ring and the shaft collar rest against one another locking the shaft in place Step 8 Tighten the set screw using the 7 64 inch T handle Allen wrench provided Step 9 Raise the drive unit to its home position Remove the height gauge from the basket shaft Step 10 Repeat steps 3 9 for each of the remaining positions Step 11 The basket shafts are set at the appropriate height so when the baskets are installed and the drive unit lowered they are at the USP specified height of 25 2 mm above the bottom of the vessel Installing Rotating Cylinders Note If using rotating cylinders it is easier to install the evaporation QS covers prior to installing the rotating cylinders See Installing Standard Evaporation Covers on page 36 or Installing Basket Low loss Evaporation Covers on page 37 as appropriate for the type of evaporation covers included with your system Step 1 Step 2 Raise the drive unit to its home position Carefully insert a rotating cylinder shaft into the spindle until approximately half of the shaft is above the top of the spindle Varian Inc Page 32 VK 7025 Dissolution Apparatus Revision G 01 06 Setup Operator s Manual P N 70 9033 Step 3 Press and hold DRIVE DOWN until the drive unit is at its lowest position Note There is a safety me
47. eating 72 Start Method 73 Method Editor 84 Chapter 6 Fiber Optics 93 Installing Fiber Optics 93 Chapter 7 Maintenance and Troubleshooting 97 Maintenance 97 Daily Maintenance 97 Paddle Basket Shaft Care 99 Basket Care 100 Water Bath Acrylic Care 101 Repairing Leaking Fittings 102 Removing the Top Cover 103 Replacing the Top Cover 103 Cleaning the Cannulas 103 Cleaning the Cannulas Using the VK 8000 Clean System Function 104 Replacing the Flanges 106 Report Center Impact Printer 107 Installing the Cartridge Ribbon 107 Replacing the Paper Roll 108 Toggling Your Printer Online 110 Printer Self Test 110 Varian Inc Table of Contents Chapter 8 Printer Configuration 111 Fuse Replacement 113 Troubleshooting 114 Service and Warranty 117 Exclusions and Limitations 118 Obtaining Warranty Service 118 Warranty Limitations 118 Exclusive Remedies 119 Index 121 Tell Us How We Are Doing 125 Varian Inc List of Figures FIGURE 1 FIGURE 2 FIGURE 3 FIGURE 4 FIGURE 5 FIGURE 6 FIGURE 7 FIGURE 8 FIGURE 9 Lifting Straps 20 VK 7025 Lifting Guide 21 VK 7025 Foot 23 Drive Unit Guide Rods 24 Drive Unit Release Lever 24 Centering Verification Gauge 34 EaseAlign Centering Ring 34 Standard Evaporation Cover 36 Evaporation Cover for Low Loss or Baskets 37 Varian Inc List of Figures FIGURE 10 FIGURE 11 FIGURE 12 FIGURE 13 FIGURE 14 FIGU
48. ed Steps 1 5 below are necessary only when replacing a vessel Step 1 Loosen the tangential screw on the lower ring flange Note IE There are two flanges an upper ring flange and a lower ring flange The lower ring flange is thicker and contains the magnets which secure the vessel to the vessel plate FIGURE 19 TruCenter Vessel exploded view upper ring flange lower ring flange tangential screw groove for the magnetic ring flanges Varian Inc Revision G 01 06 VK 7025 Dissolution Apparatus Page 107 P N 70 9033 Operator s Manual Maintenance and Troubleshooting Step 2 To slide the upper and lower ring flanges off the old vessel gently pull out and up until they clear the groove in the vessel Step 3 Align the upper and lower ring flanges so they nestle together and do not slide Step 4 Slide the ring flanges onto the new vessel so they rest in the groove in the vessel Step 5 Tighten the tangential screw on the ring flange Note d _ Do not overtighten the tangential screw or damage to the vessel could occur Report Center Impact Printer The following is helpful information for using your impact printer Installing the Cartridge Ribbon If the printer is used infrequently the print impression sometimes becomes weak because the ribbon dries out If the printed material is difficult to read and you suspect this is the cause of the problem adv
49. en ENABLED and DISABLED When disabled the paddles or baskets rotate only when the drive unit is at the correct operating height When enabled the paddles or baskets rotate when the drive unit is at any height Tester ID Select TESTER ID to enter an identification number for the dissolution apparatus This number appears with the dissolution apparatus serial number on the printout Dly After Ini Tmp Select DLY AFTER INI TMP to enter a delay duration between the measuring of the initial temperature and the DDMs opening Varian Inc Page 56 Administrator Operation VK 7025 Dissolution Apparatus Revision G 01 06 Operator s Manual P N 70 9033 Setting the Clock From the System Setup Menu 2 screen select CLOCK The Clock Functions screen displays Following is a description of the Clock Functions screen options Option Response Set Date Select SET DATE The cursor flashes Enter the correct date and press ENTER The correct date displays Set Time Select SET TIME The cursor flashes Enter the correct time in 24 hour format and press ENTER The correct time displays Date Format Select DATE FORMAT to toggle between MM DD YYYY and DD MM YYYVY Press ESC to return to the System Setup Menu 2 screen Setting Communication Port Functions From the System Setup Menu 2 screen select COMM PORT FUNCTIONS The Comm Functions screen displays Following is a descri
50. er optic probe is 4 4 inches from the top of the assembly housing see Figure 16 Fiber Optic Assembly Setting below FIGURE 16 Fiber Optic Assembly Setting fiber optic probe thermistor upper locking clip alignment pin 3 8 set screw 1 8 set screw Varian Inc Revision G 01 06 VK 7025 Dissolution Apparatus Page 95 P N 70 9033 Operator s Manual Fiber Optics Step 7 Tighten the two set screws to lock the fiber optic probe in place see Figure 16 Fiber Optic Assembly Setting on page 94 Step 8 Ensure the locking clip is in place against the assembly housing Step 9 Ensure the drive unit is in the lowest position Step 10 Place the fiber optic assembly into the opening in the top of the drive unit corresponding to vessel position 1 Step 11 Use the alignment pin and coordinating notch to guide the assembly through the opening in the top cover leaving approximately 1 4 inch of the PEEK assembly housing exposed Step 12 Repeat steps 2 11 for all remaining vessel positions Step 13 From the System Setup Menu 1 screen select CALIBRATION gt CANNULA HEIGHT CALIBRATION The Set Sampling Depth screen displays with factory set values for each apparatus If you are using paddle over disk or rotating cylinder select MENU 2 to view these apparatus SET SAMPLING DEPTH BASKET 900 mL MOVE 200 UP BASKET 500 mL MOVE 400 DOWN PADDLE 900 mL 200 PADDLE 500 mL MENU 2 400 CANNULA
51. ester is the primary disconnect for the instrument The tester should be positioned to allow accessibility to the power cords for easy disconnection FIGURE 2 VK 7025 Lifting Guide drive unit do not lift vessel plate do not lift base plate lift Varian Inc Page 22 VK 7025 Dissolution Apparatus Revision G 01 06 Setup Operator s Manual P N 70 9033 Setting Up the VK 7025 Complete the following steps to safely set up your VK 7025 Warning Ensure the tester is configured at the factory for the voltage supplied Step 1 Ensure the power switch on the power supply box is in the OFF position Warning The electrical connection at the back of the tester is the primary disconnect for the instrument Step 2 Connect the power cord between the receptacle on the side of the dissolution apparatus and an outlet of the appropriate voltage Step 3 Turn on the dissolution apparatus PRESS DRIVE UP TO INITIALIZE INSTRUMENT displays Step 4 Press and release DRIVE UP to lift the drive unit to its home position Step 5 Turn off the dissolution apparatus Step 6 Remove the cushioning material between the drive unit and vessel plate Step 7 Level the instrument by placing the bubble level provided in the accessory kit on the vessel plate Check for level in the center of the front and rear of the instrument and on the left and right sides of the instrument The feet supporting the tester are
52. ethod At the desired time interval pull samples from each vessel Two minutes after the final keystroke the Test in Progress screen displays Note For vessel positions 1 6 remove the knobbed evaporation plug pull the sample and replace the knobbed evaporation plug see Figure 14 Basket Low loss Evaporation Cover Positioning and I Sampling on page 68 For vessel positions 7 and 8 place the long cannula part number 17 3315 into the vessel through the opening in the DDM See Setting the Manual Sampling Cannula on page 38 To quit the test from the Test in Progress screen press ESC once to return to the Method Status screen and a second time to quit the test Varian Inc Page 72 VK 7025 Dissolution Apparatus Revision G 01 06 Operation Operator s Manual P N 70 9033 Setting Delayed Heating Note I gt For this option if you enter a value outside of the acceptable range an error message displays indicating appropriate values By default the delayed heating option is disabled To enable delayed heating complete the following steps Step 1 From the Main Menu select DELAYED HEATING The Delayed Heating screen displays Step 2 Enter the desired start date in the appropriate format and press ENTER ENTER TIME HH MM SS displays Note o Any time and day of the week is acceptable Pumping functions U gt are not affected by the delay This feature
53. final keystroke the Test in Progress screen displays Note For vessel positions 1 6 remove the knobbed evaporation plug pull the sample and replace the knobbed evaporation plug For vessel positions 7 and 8 place the long cannula part number dQ gt 17 3315 into the vessel through the opening in the DDM See Setting the Manual Sampling Cannula on page 38 To quit the test from the Test in Progress screen press ESC once to return to the Method Status screen and a second time to quit the test Rotating Cylinder Note a When using rotating cylinders ensure USE STANDARD START HEIGHT displays If not select USE ALTERNATE START HEIGHT USE STANDARD START HEIGHT displays Step 1 Press RUN RAISE DRIVE TO INSTALL PATCHES PRESS RUN TO MOVE DRIVE TO STANDARD START POSITION displays Step 2 Press DRIVE UP to raise the drive unit to the home position Step 3 Install the patches on the rotating cylinders Varian Inc Revision G 01 06 VK 7025 Dissolution Apparatus Page 71 P N 70 9033 Operator s Manual Operation Step 4 Press RUN LOWERING DRIVE displays and the drive unit lowers to the operating position The Method Status screen displays and the cylinders rotate Note I To quit the test from the Method Status screen press ESC and select EXIT The Manual Operation screen displays Step 5 Continue the dissolution test according to the prescribed m
54. first turn on the instrument it prints a READY message to assure you that the built in microprocessor is operating properly When you turn off the printer wait at least three seconds before turning it on again Printer Self Test You can test the print head and ribbon only after inserting paper Do not attempt to print without paper Follow these steps to perform a printer self test Step 1 Turn off the dissolution apparatus Step 2 Press and hold the printer toggle switch in the Paper feed position Step 3 Turn on the dissolution apparatus Step 4 Hold the printer toggle switch until printing begins The printer prints a list of the current configuration settings and performs a continuous print test Step 5 Press the printer toggle switch to the OnLine Off Line position to stop the printing operation Step 6 The printer is ready to resume normal operation Varian Inc Revision G 01 06 VK 7025 Dissolution Apparatus Page 111 P N 70 9033 Operator s Manual Maintenance and Troubleshooting Printer Configuration Note The printer configuration is set by the factory This procedure I gt should be performed only if the printer displays erroneous characters Contact the Dissolution Systems Service Department for assistance if necessary Step 1 Turn off the dissolution apparatus Step 2 Press and hold the printer toggle switch in the OnLine Off Line position while turning on the instrument Hold t
55. g Shipping damage rarely occurs but if it does contact both the carrier who delivered the instruments and the Dissolution Systems Service Department Though claims for damage should be filed with the carrier we can help you file a claim Varian Inc Page 20 VK 7025 Dissolution Apparatus Revision G 01 06 Setup Operator s Manual P N 70 9033 Step 2 Remove all packing from the dissolution apparatus Warning The VK 7025 weighs approximately 200 pounds and therefore requires special handling Step 3 There are four lifting straps included with the dissolution apparatus One is positioned around each of the four legs Step 4 Place the straps around your wrist as indicated in Figure 1 Lifting Straps below FIGURE 1 Lifting Straps Warning Because of its heavy weight two people should lift the tester Do not lift the tester by the drive unit Lift by holding the base plate Step 5 Use the lifting straps to lift the dissolution apparatus off of the packing platform Place the dissolution apparatus on the ground Varian Inc Revision G 01 06 VK 7025 Dissolution Apparatus Page 21 P N 70 9033 Operator s Manual Setup Step 6 Once clear of the packaging materials use the hand holds grooved into the base plate to lift the dissolution apparatus onto a sturdy benchtop see Figure 2 VK 7025 Lifting Guide below Warning The electrical connection at the back of the t
56. gh the corresponding DDM tube Otherwise skip this step and continue to step 3 Step 3 Press RUN The Method Status screen displays and the paddles rotate Note I gt To quit the test from the Method Status screen press ESC and select EXIT The Start Method screen displays Step 4 Continue the dissolution test according to the prescribed method Two minutes after either the cannulas return to the home position or the final keystroke the Test in Progress screen displays Note aqal ns To quit the test from the Test in Progress screen press ESC once to return to the Method Status screen and a second time to quit the test Varian Inc Page 78 VK 7025 Dissolution Apparatus Revision G 01 06 Operation Operator s Manual P N 70 9033 Baskets Note I gt If using baskets ensure final temp is enabled or disabled See Sample Vessel Temp on page 88 Step 1 From the Start Method screen select INSTANT START RAISE DRIVE TO INSTALL BASKETS PRESS RUN TO MOVE DRIVE TO STANDARD START POSITION displays Step 2 Press DRIVE UP to raise the drive unit to the home position Step 3 Install the baskets containing the dosage units Step 4 If using the low loss evaporation covers replace the covers on the vessels Visually align the DDM tube with the DDM alignment attachment and the cannula assembly with the opening in the evaporation cover Step 5 Press RUN LOWER
57. h and heater circulator tubing for algae or other materials If algae is present change the bath water and add an algaecide If you use a water bath algaecide or clear bath product ensure it is compatible with PETG and acrylic Monthly Maintenance See Paddle Basket Shaft Care on page 99 Basket Care on page 100 and Water Bath Acrylic Care on page 101 as applicable for additional information on proper maintenance of your equipment e Drain the water from the water bath and clean the bath thoroughly Refill the water bath and add an algaecide e Clean and lubricate the upper and lower portion of the support legs with the recommended synthetic lubricant Varian Inc Revision G 01 06 VK 7025 Dissolution Apparatus Page 99 P N 70 9033 Operator s Manual Maintenance and Troubleshooting e It is recommended that the water bath temperature probe jack is checked for surface corrosion and wiped clean with a soft cloth or nonabrasive pad every one to three months Note OD gt Depending on the frequency of use it may be necessary to complete this maintenance procedure more often Paddle Basket Shaft Care 1 When using with corrosive materials such as hydrochloric acid or media containing salts be sure to rinse them thoroughly with deionized water immediately after each use and dry thoroughly with a soft towel or cloth 2 Do not clean with abrasive cleansers or cloths Use deionized w
58. h evaporation cover drop the dosage unit qd and replace the knobbed evaporation plug see Figure 13 Standard Evaporation Cover Dropping Dosage Unit and Sampling on page 65 For vessel positions 7 and 8 drop a dosage unit into each vessel through the corresponding DDM tube Step 8 Continue the dissolution test according to the prescribed method At the desired time interval pull samples from each vessel Two minutes after the final keystroke the Test in Progress screen displays Note For vessel positions 1 6 remove the knobbed evaporation plug pull the sample and replace the knobbed evaporation plug see Figure 13 Standard Evaporation Cover Dropping Dosage Unit and Sampling on page 65 For vessel positions 7 and 8 place de gt the long cannula part number 17 3315 into the vessel through the opening in the DDM See Setting the Manual Sampling Cannula on page 38 To quit the test from the Test in Progress screen press ESC once to return to the Method Status screen and a second time to quit the test Varian Inc Revision G 01 06 VK 7025 Dissolution Apparatus Page 67 P N 70 9033 Operator s Manual Operation Baskets Note On the Manual Operation screen USE STANDARD START HEIGHT z displays To use this setting continue with the directions indicated below To switch to the alternate height setting select USE STANDARD START HEIGHT USE ALTERNATE START HE
59. he Ready LED illuminates Replace the paper if necessary If you get ribbon ink on the printer s plastic cover remove it immediately Once dried it is difficult to remove Replacing the Paper Roll Step 1 Step 2 Step 3 Toggle the printer off line by pressing the printer toggle switch to the OnLine Off Line position When the printer is off line the Ready LED does not illuminate Grasp the paper roll cover firmly by the grooves on the side and the front edge Pull outward to remove the cover Press the printer toggle switch to Paper feed to advance the paper approximately one inch beyond the paper cutter Varian Inc Revision G 01 06 VK 7025 Dissolution Apparatus Page 109 P N 70 9033 Operator s Manual Maintenance and Troubleshooting Step 4 Using scissors cut the paper feeding to the printer and remove the paper roll Step 5 Pull the remaining paper through the printer mechanism Pull the paper from the front paper cutter side Pulling the paper out of the back of the printer will damage the print mechanism Step 6 Unroll several inches of paper on the new roll Step 7 If it is jagged cut a straight edge on the paper roll to facilitate the entry of the paper into the printer Step 8 Slide the paper through the slot connecting the paper compartment and the printer compartment You can slide it in approximately 1 4 inch before it stops Step 9 While holding the paper in place press the pri
60. he date displays USP Cal Menu Use this option to enter calibration and expiration dates See Calibration Calendar on page 53 Bath Temp Limit Use this option to set an alarm to sound if the water bath temperature exceeds the set limit Select BATH TEMP LIMIT The cursor flashes Enter the limit and press ENTER The bath temperature limit displays on the screen Entering a value of 0 0 disables the alarm Varian Inc Revision G 01 06 VK 7025 Dissolution Apparatus Page 53 P N 70 9033 Operator s Manual Administrator Operation Calibration Calendar From the Setup Alarms screen select USP CAL MENU The Calibration Calendar screen displays Following is a description of the Calibration Calendar screen options Option Response Basket Calibration Date Enter the date the calibration was performed in the appropriate format and press ENTER Paddle Calibration Date Enter the date the calibration was performed in the appropriate format and press ENTER Basket Expiration Date Enter the calibration expiration date in the appropriate format and press ENTER Paddle Expiration Date Enter the calibration expiration date in the appropriate format and press ENTER An alarm sounds when an entered date is reached ALARM BASKET CAL DUE ALARM PADDLE CAL DUE or ALARM PM DUE displays Press CLEAR to silence the alarm Press ESC to return to the Setup Alarms screen When all approp
61. he printer toggle switch in the OnLine Off Line position for six seconds after the instrument is turned on then release the switch Step 3 The printer should print SETUP MENU and CONFIGURE NEXT OK If this message does not print repeat steps 1 through 3 Step 4 The printer toggle switch is used to complete the configuration Pressing the left side of the printer toggle switch selects NEXT to advance to the next menu item Pressing the right side of the printer toggle switch selects OK to accept what is stated on this line of the menu item Each time the switch is pressed another part of the menu prints Allow the printer to finish printing before pressing the switch again See the table of commands on the following page Note The printout is easier to read if the printer cover is removed Varian Inc Page 112 VK 7025 Dissolution Apparatus Revision G 01 06 Maintenance and Troubleshooting Operator s Manual P N 70 9033 SETUP MENU CONFIGURE NEXT OK Press NEXT to avoid configuration CUSTOM NEXT OK Press OK to enter custom mode CUSTOM MENU PRINT CUSTOM SETUP NEXT OK Press NEXT AUTO SEQ NO NEXT OK Press OK ZERO NEXT OK Press OK POUND SIGN NEXT OK Press OK _ UNDERSCORE NEXT OK Press OK ONLINE OFFLINE YES NEXT OK Press OK EXT CH SET NO NEXT OK Press OK PRINT READY YES NEXT OK Press NEXT PRINT READY NO NEXT OK Press OK READY
62. in and could result in damage to the instrument or personal injury Step 6 Push the fuse compartment holder into the power entry module until both sides snap Replace the power cord Varian Inc Page 114 Maintenance and Troubleshooting VK 7025 Dissolution Apparatus Operator s Manual Troubleshooting The Dissolution Systems Service Department can assist you if you experience problems or have questions concerning your dissolution apparatus Many problems can be traced to simple sources and are easily solved Following is a troubleshooting guide which may help you Revision G 01 06 P N 70 9033 Problem Suggested Solution The display screen freezes Press STOP PAUSE and ENTER at the same time to restart the system All administrative passwords are forgotten or deleted Contact the Dissolution Systems Service Department Following is a list of error messages that may display on your screen and the suggested solution Error Message Suggested Solution Spindle board error RPM NOT AT SETPOINT Ensure nothing is blocking the paddle or basket preventing it from rotating Temperature board error HEATER SENSOR EXCEEDS BATH SENSOR BY 5 DEGREES Check bath water level Ensure the heater circulator is primed and water is flowing Temperature board error HEATER TEMP RISE EXCEEDS 0 284 DEGREES PER SEC Check bath water level Ensure the heater circulator
63. in place Step 8 Tighten the set screws using the 7 64 inch T handle Allen wrench provided Step 9 Raise the drive unit to its home position Remove the height spheres from the vessels Step 10 Lower the drive unit until it stops The paddles are set at the USP specified height of 25 2 mm above the bottom of the vessel Installing Basket Shafts Step 1 Step 2 Step 3 Step 4 Raise the drive unit to its home position Carefully insert a basket shaft into each spindle until approximately half of the shaft is above the top of the spindle Clip the basket height gauge onto a shaft Press and hold DRIVE DOWN until the drive unit is at its lowest position Note There is a safety mechanism in the bottom of the left side guide rod which keeps the drive unit from lowering improperly If the ON rods do not line up precisely with the holes in the vessel plate the mechanism engages and the drive unit stops lowering and rises to the home position See Figure 4 Drive Unit Guide Rods on page 24 Step 5 Gently press down the basket shaft until the bottom of the gauge rests against the bottom of the vessel Be careful not to use excessive pressure or the bottom of the vessel may crack Varian Inc Revision G 01 06 VK 7025 Dissolution Apparatus Page 31 P N 70 9033 Operator s Manual Setup Step 6 Place a shaft locking ring on the top of the shaft and slide it down until it rests on th
64. ing Basket Low loss Evaporation Covers on page 37 as appropriate for the type of evaporation covers included with your system Step 1 Raise the drive unit to its home position Step 2 Carefully insert a paddle into each spindle until approximately half of the shaft is above the top of the spindle Step 3 Place a 25 mm height sphere in each of the vessels Note A When using paddle over disk insert the disk in the vessel and set the paddle height to 25 2 mm over the disk Step 4 Press and hold DRIVE DOWN until the drive unit is at its lowest position Note There is a safety mechanism in the bottom of the left side guide rod which keeps the drive unit from lowering improperly If the rods do not line up precisely with the holes in the vessel plate the mechanism engages and the drive unit stops lowering and rises to the home position See Figure 4 Drive Unit Guide Rods on page 24 Step 5 Gently press down each paddle shaft until the bottom of the paddle blade rests against the height sphere Step 6 Place a shaft locking ring on the top of each shaft and slide it down until it rests on the shaft collar Varian Inc Page 30 VK 7025 Dissolution Apparatus Revision G 01 06 Setup Operator s Manual P N 70 9033 Step 7 Rotate each shaft locking ring so the drive positioning teeth on both the shaft locking ring and the shaft collar rest against one another locking the shaft
65. ing INSTANT START the DDM Spin Temp Temp following information displays disabled enabled or enabled enabled or METHOD STARTUP STATUS SAMPLING disabled disabled INITIAL TEMPERATURE MANUAL TABLET DROP PRESS STOP TO STOP PADDLES PRESS RUN TO CONTINUE disabled enabled disabled enabled or METHOD STARTUP STATUS MANUAL disabled TABLET DROP PRESS STOP TO STOP PADDLES PRESS RUN TO CONTINUE disabled disabled disabled enabled or METHOD STARTUP STATUS MANUAL disabled TABLET DROP PRESS RUN TO CONTINUE enabled enabled or enabled enabled or METHOD STARTUP STATUS SAMPLING simultaneous or disabled disabled INITIAL TEMPERATURE SIMULTANEOUS sequential SEQUENTIAL DELIVERY STARTED enabled enabled or disabled enabled or METHOD STARTUP STATUS simultaneous or disabled disabled SIMULTANEOUS SEQUENTIAL DELIVERY sequential STARTED Varian Inc Revision G 01 06 VK 7025 Dissolution Apparatus Page 77 P N 70 9033 Operator s Manual Operation Step 2 If DDM is disabled and paddle spin or initial temp is enabled press STOP to drop the dosage unit into non rotating media Manually drop a dosage unit into each vessel Note For vessel positions 1 6 remove the knobbed evaporation plug qE gt on the outside of each evaporation cover drop the dosage unit and replace the knobbed evaporation plug For vessel positions 7 and 8 drop a dosage unit into each vessel throu
66. int the serial numbers of the vessels paddles baskets and shafts and rotating cylinders entered under the System Setup Menu 2 screen see Setting Serial Numbers on page 57 Varian Inc Page 92 VK 7025 Dissolution Apparatus Revision G 01 06 Operation Operator s Manual P N 70 9033 This page was intentionally left blank except for this message Varian Inc Chapter 6 Fiber Optics Installing Fiber Optics To install and set the height for the fiber optic assemblies complete the following steps Step 1 Log into the VK 7025 as an administrator Step 2 Clip the ferrule onto the fiber optic probe see Figure 15 Fiber Optic Assembly below FIGURE 15 Fiber Optic Assembly rer fiber optic probe ferrule Varian Inc Page 94 VK 7025 Dissolution Apparatus Revision G 01 06 Fiber Optics Operator s Manual P N 70 9033 Step 3 Insert the fiber optic probe into the PEEK assembly housing Step 4 Ensure the ferrule is positioned so once inside the assembly housing the window is oriented away from the set screws Step 5 Ensure the upper locking clip is in place near the top of the thermistor and insert the thermistor into the PEEK assembly housing see Figure 16 Fiber Optic Assembly Setting below Step 6 Slide both the fiber optic probe and thermistor through the assembly housing so the top of the thermistor is 1 5 inches from the assembly housing and the top of the fib
67. itialize the dissolution apparatus The drive unit moves to the home position and the Login screen displays Step 3 Enter the user identification Login ID and press ENTER Step 4 Enter the password and press ENTER The System Setup Menu 1 screen displays Step 5 Select ADMINISTRATION The Administration screen displays Step 6 Select ADD USER The Enter User ID and Password screen displays Step 7 Enter the new user identification and press ENTER Note To display a letter hold down the number key until the appropriate letter displays then release the key For example to display the letter C press and hold 2 As you hold the number key the 2 displays and is replaced by an A then a B and finally a C If you continue to hold the 2 these characters continue to scroll until you release the number key Step 8 Enter the new user password and press ENTER Step 9 Confirm the new password and press ENTER Varian Inc Page 42 VK 7025 Dissolution Apparatus Revision G 01 06 Setup Operator s Manual P N 70 9033 Step 10 Determine the security level for the new user by selecting ADMINISTRATOR SUPERVISOR or OPERATE ONLY The Administration screen displays Step 11 Repeat steps 6 10 until all users identifications passwords and security levels have been entered Step 12 Delete the preprogrammed user identification and password that came with your dissolution apparatus see Deleting P
68. le housing The evaporation cover floats in place Step 4 Repeat steps 1 3 for vessel positions 2 and 3 Step 5 For vessel position 4 place the knobbed evaporation plug in the right manual sampling hole and the evaporation plug in the left manual sampling hole see Figure 8 Standard Evaporation Cover above Step 6 Repeat steps 2 3 and 5 for the remaining vessel positions Varian Inc Revision G 01 06 VK 7025 Dissolution Apparatus Page 37 P N 70 9033 Operator s Manual Setup Installing Basket Low loss Evaporation Covers The evaporation cover for low loss or baskets comes with two DDM alignment attachments Both attachments aid the alignment of the evaporation cover on the vessel The open alignment attachment allows use of the DDM The solid alignment attachment reduces evaporation and blocks use of the DDM If using the optional evaporation cover for use with baskets or for low loss complete the following steps Step 1 Determine which DDM alignment attachment is appropriate for your system and screw the attachment into the opening in the evaporation cover see Figure 9 Evaporation Cover for Low Loss or Baskets below FIGURE 9 Evaporation Cover for Low Loss or Baskets open DDM alignment attachment solid DDM alignment attachment Step 2 If using paddles or rotating cylinders remove the apparatus from vessel position 1 Feed the shaft through the center hole of the evaporati
69. method complete the following steps Step 1 From the Method Menu screen select COPY METHOD The Select Method Location to Copy From screen displays Step 2 Select the method location to copy from by selecting PREVIOUS and NEXT until the desired method number is highlighted Step 3 Select SELECT The Select Method Location to Copy To screen displays Step 4 Select the location to copy to by selecting PREVIOUS and NEXT until the desired method location is highlighted Step 5 Select SELECT The Method List screen displays with the copied method listed Step 6 Press ESC to return to the Method Menu screen Varian Inc Page 90 VK 7025 Dissolution Apparatus Revision G 01 06 Operation Operator s Manual Step 7 Press ESC again to return to the Main Menu Storing Methods To save a new or modified method complete the following steps Step 1 Step 2 Step 3 Step 4 From the Method Menu screen select STORE METHOD to save the information The Select Method Location to Store At screen displays Scroll up or down the list by selecting NEXT or PREVIOUS until the desired method location is highlighted Select SELECT The Method List screen displays with the stored method listed Press ESC to return to the Method Menu screen or press MENU to return to the Main Menu Print Reports To print information to the Report Center Printer select PRINT REPORTS from the Main Menu The Print Reports screen
70. n page 46 Step 1 Step 2 Step 3 Step 4 Press RUN If paddle spin is disabled METHOD STARTUP STATUS MANUAL TABLET DROP PRESS RUN TO CONTINUE displays If paddle spin is enabled METHOD STARTUP STATUS MANUAL TABLET DROP PRESS STOP TO STOP PADDLES PRESS RUN TO CONTINUE displays If paddle spin is enabled press STOP If paddle spin is disabled skip this step and continue to step 3 Pull up the shaft locking ring to lift each paddle out of the medium Remove the knobbed evaporation plug on the outside of the evaporation cover at vessel position 1 drop the dosage unit and replace the knobbed evaporation plug See Figure 13 Standard Evaporation Cover Dropping Dosage Unit and Sampling below FIGURE 13 Standard Evaporation Cover Dropping Dosage Unit and Sampling Varian Inc Page 66 VK 7025 Dissolution Apparatus Revision G 01 06 Operation Operator s Manual P N 70 9033 Step 5 Push down the paddle shaft at vessel position 1 Step 6 Press RUN The Method Status screen displays and the paddles rotate Note qd To quit the test from the Method Status screen press ESC and select EXIT The Manual Operation screen displays Step 7 At the desired time intervals manually drop a dosage unit into each additional vessel and push down the corresponding paddle shaft Note For vessel positions 2 6 remove the knobbed evaporation plug on the outside of eac
71. nd return lines are connected to the sampling and return cannulas of each cannula assembly according to the following order red 1 white 2 blue 3 purple 4 yellow 5 clear 6 green 7 and brown 8 Install the cannula assemblies in the appropriate opening in the top cover according to the order listed in step 1 Use the alignment pin and coordinating notch to guide each assembly through the opening in the top cover Complete Cannula Height Calibration on page 50 to perform the electronic adjustment Varian Inc Page 36 VK 7025 Dissolution Apparatus Revision G 01 06 Setup Operator s Manual P N 70 9033 Installing Standard Evaporation Covers To place the evaporation covers onto the spindles complete the following steps Step 1 For vessel position 1 place the knobbed evaporation plug in the left manual sampling hole and the evaporation plug in the right manual sampling hole see Figure 8 Standard Evaporation Cover below FIGURE 8 Standard Evaporation Cover opening for opening for DDM tube cannula assembly knobbed evaporation plug evaporation plug in left in right manual sampling hole manual sampling hole Step 2 Align the appropriate openings in the evaporation cover with the plastic DDM tube extending from the bottom of the drive unit and the cannula assembly Step 3 Apply gentle upward pressure until the top of the evaporation cover slides over the O ring on the spind
72. nful electric shock Periodic maintenance needs may vary depending on frequency of instrument usage Daily Maintenance See Paddle Basket Shaft Care on page 99 Basket Care on page 100 and Water Bath Acrylic Care on page 101 as applicable for additional information on proper maintenance of your equipment e All parts exposed to the dissolution media should be cleaned after each use Parts made from stainless steel such as paddle and basket shafts cannulas and temperature probes are particularly susceptible to surface corrosion if not cleaned Varian Inc Page 98 VK 7025 Dissolution Apparatus Revision G 01 06 Maintenance and Troubleshooting Operator s Manual P N 70 9033 thoroughly after use If any stainless steel parts show signs of surface discoloration lightly wipe the surface with a soft cloth or nonabrasive pad to remove it e Carefully wipe the paddles or basket shafts after each use e Carefully wash the dissolution baskets after each use e Carefully wash the dissolution vessels after each use Caution Use care when washing the TruCenter vessels as heat over 65 C can damage the plastic of the magnetic ring flanges Weekly Maintenance See Paddle Basket Shaft Care on page 99 Basket Care on page 100 and Water Bath Acrylic Care on page 101 as applicable for additional information on proper maintenance of your equipment e Inspect the water bat
73. ng clamp over one end of the longer length of tubing that is connected to the back of the water bath Carefully place this end of the tubing over the outlet port on the heater circulator Slide it on until it meets the heater circulator Slide the clamp toward the end until it is over the outlet port and tighten with a screwdriver This ensures a leak free connection Caution Do not overtighten the tubing clamps Damage to the plastic tubing could result Step 8 Step 9 Step 10 Step 11 Step 12 Plug the supplied bath temperature probe into the jack on the rear panel of the tester labeled BATH TEMP Place the end of the temperature probe through the small hole in the back of the vessel plate Do not fill the water bath at this time Plug one end of the six pin DIN cable into the rear of the heater circulator and the other end of the cable into the jack on the rear panel of the tester labeled HEATER CIRC The heater circulator uses the temperature measured by the bath temperature probe to control the water bath temperature Ensure the power switch on the heater circulator is in the OFF position Locate the accessory kit Remove the power cord and plug the female end into the AC line fuse connector on the rear panel of the heater circulator Plug the heater circulator into an AC outlet of the proper voltage Varian Inc Revision G 01 06 VK 7025 Dissolution Apparatus Page 27 P N 70 9033 Oper
74. not clean with abrasive cleansers or cloths Use deionized water whenever possible If you must use a cleanser or solvent be sure that it is as mild as possible non abrasive and fully compatible with PETG and acrylic before use If in doubt call the service department for advice before proceeding 3 Do not use ammonia window cleaning sprays kitchen scouring compounds or solvents such as acetone gasoline benzene alcohol carbon tetrachloride or lacquer thinner These can scratch the material s surface and or weaken it causing small surface cracks called crazing 4 Our recommendations include but are not limited to the following e Hot water lt 150 F e Household ammonia Vinegar 5 Glacial Acetic Acid e Ethyl alcohol maximum 10 Varian Inc Page 102 VK 7025 Dissolution Apparatus Revision G 01 06 Maintenance and Troubleshooting Operator s Manual P N 70 9033 e Isopropyl alcohol maximum 25 Repairing Leaking Fittings Complete these steps if any of your water bath fittings are leaking Step 1 Step 2 Step 3 Step 4 Step 5 Step 6 Step 7 Step 8 Step 9 Step 10 Turn off the heater circulator and drain the water bath completely Remove the leaky bulkhead fitting Remove the elbow fitting from the bulkhead fitting Inspect the bulkhead fitting gaskets for damage and replace them as necessary Remove the old Teflon tape from all male fittings Inspect the threads for dam
75. nter toggle switch to the Paper feed position and hold until approximately one inch of paper has emerged from the top of the printer Make sure the roll of paper feeds squarely If it does not the paper will jam and possibly damage the printer mechanism Step 10 Release the printer toggle switch Step 11 Turn the paper roll to take up any slack in the paper feeding to the printer Step 12 Place the paper roll into the paper compartment Step 13 Replace the paper roll cover If the cover is difficult to remove or replace the left and right edges can be trimmed or shaved with a utility knife allowing the cover to slide easier Step 14 Toggle the printer online by pressing the printer toggle switch to the OnLine Off Line position The Ready LED illuminates Varian Inc Page 110 VK 7025 Dissolution Apparatus Revision G 01 06 Maintenance and Troubleshooting Operator s Manual P N 70 9033 Toggling Your Printer Online Complete these steps to toggle your printer online Step 1 Toggle the printer online by pressing the printer toggle switch to the OnLine Off Line position When the printer is off line the Ready LED does not illuminate Step 2 Release the switch and it returns to the center position The Ready LED illuminates and a READY message prints if the PRINT READY command has not been turned off See Printer Configuration on page 111 for instructions on turning on and off the PRINT READY command When you
76. nto place This guarantees it is positioned in the correct centering location for operation Setting Up the Water Bath and Heater Circulator The removable water bath connects directly to the inlet and outlet of the heater circulator Following are the connection procedures for the VK 7025 Dissolution Apparatus Step 1 Ensure the water bath is positioned under the vessel plate and rests firmly on the base plate Secure the vessel plate to the frame with three screws Finger tighten the screws overtightening the screws could damage the vessel plate Step 2 Locate the two tubing clamps Step 3 The heater circulator has two liquid ports one on each end The inlet is connected to the water bath outlet and the outlet which is located next to the power switch is connected to the water bath inlet Step 4 Slip a tubing clamp over one end of the short length of tubing that is connected to the underside of the water bath Carefully place this end of the tubing over the inlet port on the heater circulator Slide it on until it meets the heater circulator Step 5 Slide the clamp toward the end until it is over the inlet port and secure This ensures a leak free connection Caution Do not overtighten the tubing clamps Damage to the plastic tubing could result Varian Inc Page 26 Setup VK 7025 Dissolution Apparatus Revision G 01 06 Operator s Manual P N 70 9033 Step 6 Step 7 Slip a tubi
77. nts the sample I timepoint clock counts negative time If a value greater than the test length is entered SAMPLE POINT IS GREATER THAN METHOD LENGTH METHOD LENGTH WILL BE ADJUSTED PRESS ANY KEY TO CONTINUE displays The test length automatically adjusts to the time of the sample point Step 3 Select PREVIOUS or NEXT to scroll up or down the timepoints Varian Inc Revision G 01 06 VK 7025 Dissolution Apparatus Page 87 P N 70 9033 Operator s Manual Operation Step 4 Enter the desired timepoints and press ESC to return to the Sampling Setup screen When all appropriate parameters have been entered on the Sampling Setup screen press ESC to return to the Method Menu 1 screen Controlling Dosage Delivery Module VK 7025 with Paddles only Note DDM caps are provided to keep dust out of the DDM tubes when the equipment is not in use These caps can also be used during _S operation Remove the cap place the dosage unit in the DDM Opening in the top cover and replace the cap For the following options if you enter a value outside of the acceptable range an error message displays indicating appropriate values DDM can only be enabled if this option is installed on your tester and paddles are selected as the apparatus Sequential DDM is an option only if clutches are installed To enable the dosage delivery module complete the following steps Step 1 Select DDM DI
78. on cover and replace the apparatus following the instructions under Installing Paddles on page 29 or Installing Rotating Cylinders on page 31 as appropriate Repeat for each vessel position If using baskets place an evaporation cover on the vessel at each vessel position Visually align the DDM tube with the DDM alignment attachment and the cannula assembly with the opening in the evaporation cover Varian Inc Page 38 VK 7025 Dissolution Apparatus Revision G 01 06 Setup Operator s Manual P N 70 9033 Step 3 When lowering the drive unit to run the method stop the downward movement two inches above the vessel plate Align the evaporation cover with the cannula assembly and the DDM tube at each vessel position Lower the drive unit completely The DDM tube should rest within the DDM alignment attachment Setting the Manual Sampling Cannula To sample manually from positions 7 and 8 it is necessary to set the manual sampling cannulas to the correct length For positions 7 and 8 complete the following steps Step 1 Step 2 Step 3 Step 4 Step 5 Step 6 Step 7 From the System Setup Menu 1 screen select DIAGNOSTICS The Diagnostic Menu screen displays Select DDM TEST Position a DDM manual override adapter over the DDM at position 7 Do not press down on the adapter Select the corresponding location on the screen and the appropriate DDM opens Gentle downward pressure slides the a
79. or on its packaging indicates that this product must not be disposed of as unsorted municipal waste The separate collection and recycling of your waste equipment at the time of disposal will help to conserve natural resources and ensure that it is recycled in a manner that protects human health and the environment For more information on collection reuse and recycling systems please contact your local regional waste administration your local distributor or Varian Inc Varian Inc Page 14 VK 7025 Dissolution Apparatus Revision G 01 06 Safety Practices and Hazards Operator s Manual P N 70 9033 This page was intentionally left blank except for this message Varian Inc chapter2 Introduction The VK 7025 is designed for dissolution testing of a variety of pharmaceutical products including tablets capsules transdermal patches and membranes It can be configured as USP Apparatus 1 2 5 or 6 The unique design of the VK 7025 has a lower profile than existing dissolution apparatus The drive unit moves up and down with the touch of a key to move paddles or basket shafts into and out of the vessels In order to allow clear access to the vessels the drive unit slides back rather than continuing to move upwards This compact design has the evaporation covers attached to the spindle housings on the drive unit and offers convenient access to the mechanics of the system through a hinged top cover The front panel dis
80. p against each other Place them back into the original styrofoam shipping container or other appropriate container between uses This will prevent them from coming into contact with each other or anything else in the storage area Basket Care 1 When using with corrosive materials such as hydrochloric acid or media containing salts be sure to rinse them thoroughly with deionized water immediately after each use and dry thoroughly with a soft towel or cloth Please do not clean baskets or shafts with abrasive cleansers or cloths especially if they re gold or Teflon coated Mesh openings on baskets could enlarge which could have an effect on results Use deionized water whenever possible If you must use a cleanser or solvent be sure that it is as mild as possible non abrasive and fully compatible with fluorocarbons and stainless steel before use If in doubt contact the service department for advice before proceeding We recommend that you do not use a laboratory dishwasher Clean baskets only by hand The high temperatures to which your baskets would be subject in a dishwasher may damage the fluorocarbon coating Use caution when handling baskets It is important that they retain their cylindrical shape so take care not to kink or bend the mesh Check frequently to ensure that the mesh is completely open and that there are no rips or tears Please store baskets properly between uses Do not simply place these baskets in a drawer
81. partment or one of its representatives will at its option either repair or replace any mechanical and electrical components in your instrument which prove to be defective During the first year of warranty coverage there is no charge for the labor to repair your unit The Dissolution Systems Service Department or one of its representatives will determine the best site to repair the unit either onsite or returned to Varian Inc Any onsite warranty services are provided only at the initial installation point Installation and onsite warranty services are available only in Dissolution Systems service travel areas Varian Inc Page 118 VK 7025 Dissolution Apparatus Revision G 01 06 Service and Warranty Operator s Manual P N 70 9033 Exclusions and Limitations Excluded from this warranty are expendable or consumable items such as but not limited to paddles baskets vessels and acrylic water baths Also excluded are defects from improper or inadequate maintenance by the customer user induced chemical action or contamination unauthorized modification or misuse and improper site preparation and maintenance Operation of software is not warranted to be uninterrupted or error free Obtaining Warranty Service To obtain warranty service in the United States contact the Dissolution Systems Service Department at 800 229 1108 to obtain authorization to return units for repair At the option of the customer onsite warranty service
82. plays the Method Status screen during a run providing full information on spindle speed elapsed time temperature and more Most operating parameters are programmable including spindle speed test length bath temperature and test start times The built in Report Center Printer provides a complete report either at pre programmed time intervals or on demand of several important test parameters Printouts are on plain paper which will not fade or discolor over time or with exposure to chemical fumes Varian Inc Page 16 VK 7025 Dissolution Apparatus Revision G 01 06 Introduction Operator s Manual P N 70 9033 The VK 7025 Dissolution Apparatus comes with all accessories needed for proper function e PETG water bath e Heater circulator e USP dissolution paddles or rotating basket assemblies 14 5 inch shaft length e TruCenter Vessels 1000 mL with upper and lower magnetic ring flanges e Standard evaporation covers e Complete set of alignment tools to ensure full USP compliance e Built in Report Center Printer e Sampling cannulas e Dosage Delivery Module DDM e AutoTemp Vessel Temperature Sensing System These features are optional on the VK 7025 e Individual clutches e Fiber optic probes Warning The dissolution apparatus contains electrical circuits devices and components operating at dangerous voltages Contact with these circuits devices and components can cause death serious injury or painful electric sho
83. ps the drive unit from lowering improperly If the rods do not line up precisely with the holes in the vessel plate the mechanism engages and the drive unit stops lowering and rises to the home position Varian Inc Page 24 VK 7025 Dissolution Apparatus Revision G 01 06 Setup Operator s Manual P N 70 9033 The guide rods also serve to guarantee the drive unit is positioned with the apparatus in the correct centering location for operation See Figure 4 Drive Unit Guide Rods below FIGURE 4 Drive Unit Guide Rods guide rod safety mechanism Sliding Back the Drive Unit There are two release levers for the drive unit which keep it from sliding back One is located on either side of the drive unit FIGURE 5 Drive Unit Release Lever latch 7S unlatch VY To slide the drive unit back complete the following steps Step 1 Ensure the drive unit has been fully raised to the home position Step 2 Place both hands on the two release levers and use your index fingers to depress the release levers Step 3 Use your thumbs to slide the drive unit back far enough to disengage it from the latching mechanism Step 4 Move your hand to the handle at the front of the drive unit and slide the drive unit back until it stops Varian Inc Revision G 01 06 VK 7025 Dissolution Apparatus Page 25 P N 70 9033 Operator s Manual Setup Step 5 When in the forward position ensure the drive unit latches i
84. ption of the Comm Functions screen options Option Response External Control Select EXTERNAL CONTROL to toggle between DISABLED and ENABLED If external control is enabled a VK 8000 or Total Solution software can control the VK 7025 To use external control you must log off the dissolution apparatus Varian Inc Revision G 01 06 VK 7025 Dissolution Apparatus Page 57 P N 70 9033 Operator s Manual Administrator Operation Option Response Baud Rate Select BAUD RATE to toggle between 2400 4800 9600 19200 28800 and 38400 The baud rate must be set to 9600 when connected to a VK 8000 or Total Solution system Comm ID Select COMM ID The cursor flashes Enter the correct communications port identification number in xx format and press ENTER The correct communications port identification number displays The communications port identification number must be 01 when connected to a VK 8000 or single Total Solution system Note a leading zero is necessary when entering a communications port identification number between 01 and 09 Press ESC to return to the System Setup Menu 2 screen Setting Serial Numbers To enter the serial numbers of your accessories complete the following steps Step 1 Step 2 Select SERIAL NUMBERS from the System Setup Menu 2 screen The Enter Serial Numbers screen displays Select VESSEL PADDLE BASKET SHAFT or ROTATING CYLINDER The cor
85. re displays Press ESC to return to the Diagnostic Menu screen Communications Bus Diagnostic Lift Board Input Test and Input amp Output Tests also display but these options are for qualified service personnel only If you have any questions about the operation of your VK 7025 see Chapter 8 Service and Warranty on page 117 or contact the Dissolution Systems Service Department Varian Inc Revision G 01 06 P N 70 9033 VK 7025 Dissolution Apparatus Page 55 Operator s Manual Administrator Operation Menu 2 From the System Setup Menu 1 screen select MENU 2 The System Setup Menu 2 screen displays Following is a description of the System Setup Menu 2 screen options Serial Numbers Option Response Clock Select CLOCK to set the date time and date format See Setting the Clock on page 56 Comm Port Select COMM PORT FUNCTIONS to set the baud rate Functions communication port and external control The Comm Functions screen displays See Setting Communication Port Functions on page 56 Select SERIAL NUMBERS to enter the serial numbers of equipment being used See Setting Serial Numbers on page 57 Vessels Select VESSELS to select the number of vessels being used Note it is imperative to set the correct number of vessels being used or the instrument will not function properly All Position Spin Select ALL POSITION SPIN to toggle betwe
86. rectives Indicates that this product must not be disposed of as unsorted municipal waste see WEEE Directive on page 13 Varian Inc Revision G 01 06 VK 7025 Dissolution Apparatus Page 13 P N 70 9033 Operator s Manual Safety Practices and Hazards General CE Compliant Products The VK 7025 has been designed to comply with the requirements of the Electro magnetic Compatibility EMC Directive and the Low Voltage Directive LVD of the EU Varian Inc has confirmed that each product complies with the relevant directives by testing a prototype against the prescribed European Norm EN standards Proof that a product complies with the directives is indicated by e the CE marking appearing on the rear of the product e the documentation package that accompanies the product containing a copy of the declaration of conformity This declaration is the legal declaration by Varian Inc that the product complies with the directives and also shows the EN standards to which the product was tested to demonstrate compliance The declaration of conformity is signed by the representative of the manufacturing plant WEEE Directive All Varian products that are subject to the WEEE directive shipped after August 13 2005 are compliant with the WEEE marking requirements Such products are marked with the crossed out wheelie bin WEEE symbol shown on page 12 in accordance with European Standard EN 50419 This symbol on the product
87. reset User Definitions below Deleting Preset User Definitions It is recommended that you immediately change the user identification and password for Administrative control of the VK 7025 Dissolution Apparatus once your unit is installed Step 1 Step 2 Step 3 Step 4 Step 5 After entering the user identifications passwords and security levels select LIST DELETE USERS The List and Delete Users screen displays Select the preset user identification and password by selecting NEXT until the cursor flashes over the number of the appropriate user identification Select DELETE Select YES to confirm deletion The List and Delete Users screen displays Press ESC to return to the Administration screen Varian Inc Page 43 VK 7025 Dissolution Apparatus Setup Revision G 01 06 Operator s Manual P N 70 9033 Vessel Plate Layout The vessels on the VK 7025 are numbered counterclockwise beginning with the back left corner FIGURE 11 Vessel Plate Layout Varian Inc Page 44 VK 7025 Dissolution Apparatus Revision G 01 06 Setup Operator s Manual P N 70 9033 This page was intentionally left blank except for this message Varian Inc chapters Administrator Operation If your security level is supervisor or operate only continue to Chapter 5 Operation on page 59 User Settings To add list or delete users see Programming Administra
88. responding serial number screen displays with numbers 1 through 8 listed down the left side of the screen If BASKET SHAFT is selected two columns display The left column is for basket serial numbers and the right column is for shaft serial numbers Varian Inc Page 58 VK 7025 Dissolution Apparatus Revision G 01 06 Administrator Operation Operator s Manual P N 70 9033 Step 3 Enter the serial numbers for the vessel paddle basket and shaft or rotating cylinder for each of the corresponding spindle locations See Vessel Plate Layout on page 43 Note To display a letter hold down the number key until the appropriate letter displays then release the key For example to display the letter C press and hold 2 As you hold the number Ce key the 2 displays and is replaced by an A then a B and finally a C If you continue to hold the 2 these characters continue to scroll until you release the number key To delete an entry select PREVIOUS or NEXT to place the cursor on the appropriate line Press ENTER Step 4 Press ENTER to accept an entry and move to the following line until all the serial numbers have been entered When entering basket and shaft serial numbers the cursor moves from basket location 1 to shaft location 1 and then to basket location 2 followed by shaft location 2 and so on Step 5 Press ESC to return to the Enter Serial Numbers screen Step 6 Repeat steps 2 5 to enter serial
89. riate parameters on the Setup Alarms screen have been entered press ESC to return to the System Setup Menu 1 screen Varian Inc Page 54 VK 7025 Dissolution Apparatus Revision G 01 06 Administrator Operation Operator s Manual P N 70 9033 Diagnostics To check the operation of applicable options for your instrument select DIAGNOSTICS from the System Setup Menu 1 screen The Diagnostic Menu screen displays Following is a description of the Diagnostic Menu screen options Option Response DDM Test Select DDM TEST Select each location and verify the if installed corresponding DDM opens and closes Press ESC to return to the Diagnostic Menu screen Cannula Test Select CANNULA TEST Select a location and verify the if installed corresponding cannula moves down UP changes to DOWN Select the location again and verify the corresponding cannula moves up Repeat for all cannula positions Press ESC to return to the Diagnostic Menu screen Shaft Brake amp Select SHAFT BRAKE amp CLUTCH TEST Select a location Clutch Test if and verify the clutch activates OFF changes to ON Select the installed location again and verify the brake activates Repeat for all shaft positions Press ESC to return to the Diagnostic Menu screen Read Bath amp Select READ BATH amp HEATER TEMP The Bath and Heater Heater Temp Temp screen displays with the bath and heater temperatures This is the only screen where the heater temperatu
90. rning A Warning message appears in the manual when failure to observe instructions or precautions could result in death or injury Symbols depicting the nature of the specific hazard are also placed alongside warnings Varian Inc Revision G 01 06 VK 7025 Dissolution Apparatus Page 11 P N 70 9033 Operator s Manual Safety Practices and Hazards These symbols are also used on warning labels attached to the instrument When you see one of these symbols you must refer to the relevant operation or service manual for the correct procedure referred to by that warning label The meaning of the symbols that appear alongside warnings in this manual are as follows Electrical shock Pinch point Caution Refer to accompanying documents Read all warnings and cautions carefully and observe them at all times Varian Inc Page 12 VK 7025 Dissolution Apparatus Revision G 01 06 Safety Practices and Hazards Operator s Manual P N 70 9033 Caution A Caution message appears in the manual when failure to observe instructions could result in damage to equipment Varian supplied and or other associated equipment A Note appears in the manual to give advice or information G gt Information Symbols Switches main power on Switches main power off Indicates single phase alternating current Indicates the product complies with the requirements of one C or more European Union EU di
91. s The dissolution apparatus contains electrical circuits devices and components operating at dangerous voltages Contact with these circuits devices and components can cause death serious injury or painful electric shock Panels or covers that are retained by fasteners which require the use of a tool for removal may be opened only by Varian trained Varian qualified or Varian authorized service engineers Consult the manuals or product labels supplied with the dissolution apparatus to determine which parts are operator accessible Application of the wrong supply voltage connection of the instrument to an incorrectly wired supply outlet or lack of proper electrical grounding can create a fire hazard or a potentially serious shock hazard and could seriously damage the instrument and any attached ancillary equipment Always use a three wire outlet with ground connection which is adequately rated for the load The installation must comply with local state and federal safety regulations Do not connect the instrument to the main power supply until you have made sure that the operating voltage is correctly set for the main power supply in the specific outlet in your laboratory to which the equipment will be connected Other Other specific warnings and cautions appear in the manuals where appropriate and detail the specific hazard describe how to avoid it and specify the possible consequences of not heeding the warning or caution Wa
92. s ENTER The maximum allowable time is 999 59 59 Sample Vessel Temp This option is only available if AutoTemp is enabled To read the initial vessel temperature select INITIAL to toggle between ENABLED or DISABLED Note initial vessel temperature is only available if the apparatus selected is paddles To read the final vessel temperature select FINAL to toggle between ENABLED or DISABLED Alarm Point Select ALARM POINT to set an alarm to sound during the test Enter the desired alarm time in hhh mm ss format and press ENTER When all appropriate parameters have been entered on the Method Menu 2 screen press ESC twice to return to the Method Menu screen Select STORE METHOD to save the previously entered information see Storing Methods on page 90 If you do not Varian Inc Revision G 01 06 VK 7025 Dissolution Apparatus Page 89 P N 70 9033 Operator s Manual Operation select STORE METHOD and press ESC to go back further in the system the following screen displays USER xxxxx CHANGES HAVE NOT BEEN STORED PRESS CONTINUE TO CONTINUE WITHOUT SAVING OR RETURN TO RETURN TO EDITOR CONTINUE RETURN Select CONTINUE to disregard the changes and return to the Main Menu Select RETURN to display the Method Menu 1 screen and the current changes The changes have not been saved To save the changes see Storing Methods on page 90 Copying Methods To copy an existing
93. sed in this Manual 17 Quick Key Guide 18 Screen Saver 18 Chapter 3 Setup 19 Unpacking Your VK 7025 19 Setting Up the VK 7025 22 Raising and Lowering the Drive Unit 23 Varian Inc Table of Contents Chapter 4 Sliding Back the Drive Unit 24 Setting Up the Water Bath and Heater Circulator 25 Filling the Water Bath 27 Installing and Centering the Vessels 28 Installing Paddle Basket Shafts 28 Installing Paddles 29 Installing Basket Shafts 30 Installing Rotating Cylinders 31 Installing the Intrinsic Dissolution Apparatus 32 Removing the Dissolution Apparatus 33 Centering Verification 34 Installing Cannula Assemblies 35 Installing Standard Evaporation Covers 36 Installing Basket Low loss Evaporation Covers 37 Setting the Manual Sampling Cannula 38 Programming Administrative Control 40 Security Levels 40 Setting Up the User List 41 Deleting Preset User Definitions 42 Vessel Plate Layout 43 Administrator Operation 45 User Settings 45 Administration 47 Calibration 48 Bath Vessel Difference 48 Setting an Alternate Drive Unit Position 49 Cannula Height Calibration 50 Alarms 52 Calibration Calendar 53 Diagnostics 54 Menu 2 55 Setting the Clock 56 Setting Communication Port Functions 56 Setting Serial Numbers 57 Varian Inc Table of Contents Chapter 5 Operation 59 Main Menu 59 Manual Operation 60 Starting a Test 64 Paddles 65 Baskets 67 Paddle Over Disk 69 Rotating Cylinder 70 Setting Delayed H
94. sitions do not display This option is applicable only if AutoTemp is installed Paddle Spin Select PADDLE SPIN to toggle between ENABLED and DISABLED If paddle spin is disabled the paddles do not spin prior to the start of the test Note if an initial temperature is taken in the method the paddles spin regardless of whether paddle spin is enabled or disabled If paddle spin is enabled the paddles spin prior to the start of the test which allows the vessel temperature to equilibrate This removes the possibility of a temperature gradient allowing for a more accurate vessel temperature reading Menu 2 Select MENU 2 to access menus for the setting the clock and communication port functions entering serial numbers the number of vessels and the tester identification number enabling or disabling all position spin and to set a delay between the initial temperature measurement and the opening of the DDMs See Menu 2 on page 55 Varian Inc Revision G 01 06 P N 70 9033 VK 7025 Dissolution Apparatus Operator s Manual Administrator Operation Administration From the System Setup Menu 1 screen select ADMINISTRATION The Administration screen displays Following is a description of the Administration screen options Option Response Add User Select ADD USER to enter user identifications and passwords See Setting Up the User List on page 41 for instructions on adding a
95. ss MENU to return to the Main Menu ENTER After entering any input press ENTER to complete the process STOP PAUSE Press STOP PAUSE to pause or abort the present program RUN To manually begin operations that were not programmed to delay start press RUN CLEAR Press CLEAR to instantly clear an entry DRIVE UP Press DRIVE UP to raise the drive unit The drive unit automatically rises to the home position unless another key is pressed Pressing DRIVE UP or DRIVE DOWN stops the upward movement of the drive unit DRIVE DOWN Press and hold DRIVE DOWN to lower the drive unit Release the key when the drive unit is in the appropriate position Screen Saver The VK 7020 7020 S 7025 screen saver initiates after 30 minutes of inactivity and no program running Press any key to reactivate the dissolution apparatus If security has been disabled the last screen displays If security has been enabled a screen requesting the current user s password displays Enter the password and press ENTER The last screen displays Varian Inc Chapter 3 Se tup Unpacking Your VK 7025 The VK 7025 is shipped in one carton containing the following e VK 7025 drive unit assembly PETG water bath power supply box glassware and accessories e heater circulator Follow these steps to safely unpack your tester and accessories Step 1 Open the carton and check the contents for damage which may have occurred during shippin
96. t MOVE DOWN to move the cannulas to their lowest position then select MOVE UP to move the cannulas to their highest position Step 5 Select MOVE UP or MOVE DOWN to position the cannulas at the appropriate height in the vessels Varian Inc Page 52 VK 7025 Dissolution Apparatus Revision G 01 06 Administrator Operation Operator s Manual P N 70 9033 Step 6 When the cannulas are in the correct position select the appropriate apparatus and volume The number of steps the cannula motor moved to reach that position displays under the selected apparatus and volume Note For volumes between 500 mL and 900 mL the appropriate cannula height is interpolated from the 500 mL and 900 mL settings For volumes greater than 900 mL the appropriate cannula height is extrapolated from the 500 mL and 900 mL settings Step 7 Press ESC The cannulas return to the home position and the Calibration Menu screen displays When all appropriate parameters on the Calibration Menu screen have been entered press ESC to return to the System Setup Menu 1 screen Alarms From the System Setup Menu 1 screen select ALARMS The Setup Alarms screen displays the basket and paddle expirations dates and the following options Option Response PM Expiration Date Use this option to set the preventative maintenance alarm Select PM EXPIRATION DATE The cursor flashes Enter the date in the appropriate format and press ENTER T
97. ter and the cursor flashes on the corresponding line Enter the appropriate information for each item up to 25 characters Additional notes and comments up to 30 characters can be entered by selecting NOTE Complete each field using any combination of letters or numbers To display a letter hold down the number key until the appropriate letter displays then release the key Press ESC to return to the Start Method screen When running a method the text displays on the printout along with the method parameters In manual operation the lot batch data note does not display on the printout Instant Start Use this option to begin the test according to the currently selected method See Instant Start on page 75 Delay Start VK 7025 with Paddles This option displays only when using paddles with a VK 7025 Use this option to program the test to begin automatically on a specific date and time See Delay Start on page 82 Varian Inc Revision G 01 06 VK 7025 Dissolution Apparatus Page 75 P N 70 9033 Operator s Manual Operation Option Response Vessel Temp This option displays only when using paddles with a VK 7025 Start VK 7025 with Paddles You can program the test to begin automatically when the dissolution medium reaches a programmed temperature See Vessel Temp Start on page 83 Wait External Start The VK 7025 can be used with an external device for example
98. the Start Method screen select INSTANT START After selecting INSTANT START the following Paddle Spin Final Temp information displays enabled disabled or enabled METHOD STARTUP STATUS MANUAL DISK DROP PRESS STOP TO STOP PADDLES PRESS RUN TO CONTINUE disabled disabled or enabled METHOD STARTUP STATUS MANUAL DISK DROP PRESS RUN TO CONTINUE Step 2 If paddle spin is enabled press STOP If paddle spin is disabled skip this step and continue to step 3 Varian Inc Page 80 VK 7025 Dissolution Apparatus Revision G 01 06 Operation Operator s Manual P N 70 9033 Step 3 Lift each vessel evaporation cover and manually drop the disk assembly into each vessel Note If using the low loss evaporation covers press DRIVE UP to raise I gt the drive unit slightly lift each vessel evaporation cover drop the disk assembly into each vessel and press DRIVE DOWN until the drive unit is completely lowered Step 4 Press RUN The Method Status screen displays and the paddles rotate Note I gt To quit the test from the Method Status screen press ESC and select EXIT The Start Method screen displays Step 5 Continue the dissolution test according to the prescribed method Two minutes after either the cannulas return to the home position or the final keystroke the Test in Progress screen displays Note I a To quit the test from the Test in Progress screen press ES
99. timepoint manual sample elapsed time if autosampler is installed e last vessel temperatures if AutoTemp is installed and enabled in your method e user id After the first two minutes of a test the Test in Progress screen displays The Test in Progress screen details the current speed and bath temperature the time to the next sample point if applicable the elapsed time and the Manual Sample option if autosampler is installed Press ESC to return to the Method Status screen Varian Inc Page 82 VK 7025 Dissolution Apparatus Revision G 01 06 Operation Operator s Manual P N 70 9033 If you press STOP PAUSE the Method Paused screen displays The time paused and the current elapsed time display Select EXIT to stop the current method ABORTING METHOD STAND BY displays and the screen returns to the Start Method screen To continue the test select CONTINUE The Method Status screen displays Delay Start Note I For this option if you enter a value outside of the acceptable range an error message displays indicating appropriate values If you are using paddles DDMs and an autosampler you can program a delayed start based on a specific date and time If you do not select paddles and DDM in your method this option is not available To set the delayed start complete the following steps Step 1 From the Start Method screen select DELAY START The Time Delay Start Setup screen displays the c
100. tive Control on page 40 After adding the user identifications passwords and security press ESC to return to the System Setup Menu 1 screen Varian Inc Page 46 VK 7025 Dissolution Apparatus Revision G 01 06 Administrator Operation Operator s Manual P N 70 9033 Following is a description of the System Setup Menu 1 screen options Option Response Main Menu All operation functions begin at the Main Menu See Main Menu on page 59 Administration Select ADMINISTRATION to add list or delete users set edit method authority and set up security override See Administration on page 47 Calibration Select CALIBRATION in order to set the calibration information and if applicable the cannula height the bath vessel difference and the alternate start drive position See Calibration on page 48 Alarms Select ALARMS to enter the preventative maintenance PM expiration date and the bath temperature limit and to view the calibration calendar menu See Alarms on page 52 Diagnostics This option is for diagnostic purposes and if applicable independent operation of the DDMs cannulas and clutches See Diagnostics on page 54 Temp Display Select TEMP DISPLAY to toggle between ENABLED and DISABLED If temp display is enabled the vessel temperatures cannula positions display at the bottom of the system monitor screen If temp display is disabled the vessel temperatures cannula po
101. urrent date and time below the RPM and water bath temperature If temp display is enabled see Temp Display on page 46 the vessel temperatures cannula positions display as well Step 2 The cursor flashes under ENTER DATE Enter the date in the appropriate format and press ENTER ENTER TIME displays Step 3 Enter the time in 24 hour format for example 3 00 pm is entered as 15 00 00 and press ENTER The Time Delay Start Status screen displays the time until the test starts Once the test begins the Method Status screen displays see page 81 Note To abort the test from either the Time Delay Start Status screen _ or the Method Status screen press and hold ESC Once the method begins press STOP PAUSE or ESC and select EXIT The Start Method screen displays Varian Inc Revision G 01 06 VK 7025 Dissolution Apparatus Page 83 P N 70 9033 Operator s Manual Operation Vessel Temp Start Note a e l For this option if you enter a value outside of the acceptable range an error message displays indicating appropriate values If you are using paddles DDMs and an autosampler you can program the instrument to start based on the dissolution medium reaching a specific temperature To set the temperature start complete the following steps Step 1 From the Start Method screen select VESSEL TEMP START VESSEL TEMPERATURE START BATH TEMP WILL BE AD
102. user List Delete Users Select LIST DELETE USERS to list and delete user identifications and passwords See Deleting Preset User Definitions on page 42 for instructions on deleting user identifications and passwords Edit Method Authority Select EDIT METHOD AUTHORITY to toggle between ALL USERS and ADMINISTRATOR This function grants method editor privileges to the administrator and supervisor or all users Select ALL USERS to override the limited access levels for OPERATE ONLY Security Override Select SECURITY OVERRIDE to toggle between ENABLED and DISABLED If security override is enabled e when the machine is turned on the System Setup Menu 1 screen displays without requiring you to log in e you cannot log out If security override is disabled when the machine is turned on the Login screen displays and you must log in Last User The user identification of the last user and the date and time of last login displays on the screen Varian Inc Page 47 Page 48 VK 7025 Dissolution Apparatus Revision G 01 06 Administrator Operation Operator s Manual P N 70 9033 Calibration From the System Setup Menu 1 screen select CALIBRATION Spindle hours are displayed under the screen title The Calibration Menu screen displays Following is a description of the Calibration Menu screen options Option Response Bath Vessel Diff Enter the difference bet
103. ution Apparatus Page 105 P N 70 9033 Operator s Manual Maintenance and Troubleshooting Step 4 Position the cannula cleaning tray on the vessel plate so the cannulas are centered above the containers FIGURE 18 Cannula Cleaning Tray Step 5 From the Manual Operation screen set the volume to 500 mL Step 6 Select MANUAL SAMPLE The Manual Sampling screen displays Step 7 From the Manual Sampling screen select DOWN corresponding to SELECT ALL Step 8 Lower the drive unit by pressing DRIVE DOWN until the tips of the sample cannulas are below the surface of the cleaning solution Step 9 Log off the dissolution apparatus Step 10 Press CLEAN SYSTEM on the VK 8000 The cleaning process begins immediately Step 11 When the cleaning process is complete press DRIVE UP to raise the drive unit to the home position Step 12 Remove the cannula cleaning tray from the vessel plate Use a clean soft cloth to dry the exterior surfaces of the cannulas Varian Inc Page 106 VK 7025 Dissolution Apparatus Revision G 01 06 Maintenance and Troubleshooting Operator s Manual P N 70 9033 Replacing the Flanges The tester is supplied with specially designed vessels and magnetic ring flanges The magnetic ring flanges will keep the vessels centered at all times without the use of tools and prevent the vessels from floating even when they are empty Note I gt The TruCenter vessels are shipped pre assembl
104. ween the water bath temperature and the vessel temperature See Bath Vessel Difference below Set Alternate Start When performing a staggered start under manual operation Drive Position with Apparatus 1 you must set the drive unit to an alternate start position See Setting an Alternate Drive Unit Position on page 49 Cannula Height This option displays only if AutoTemp and or sampling Calibration cannulas are installed To set the sampling position for the cannulas see Cannula Height Calibration on page 50 Bath Vessel Difference Note I gt For this option if you enter a value outside of the acceptable range an error message displays indicating appropriate values To set the bath vessel difference complete the following steps Step 1 From the System Setup Menu 1 screen select CALIBRATION The Calibration Menu screen displays Step 2 From the Calibration Menu screen select BATH VESSEL DIFF Varian Inc Revision G 01 06 VK 7025 Dissolution Apparatus Page 49 P N 70 9033 Operator s Manual Administrator Operation Step 3 Enter the observed difference in the temperature between the water bath temperature and the vessel temperature The acceptable range is 0 0 to 10 0 C Press CLEAR to delete the entry or press ENTER to continue The Calibration Menu screen displays with the new bath vessel difference value Note I This value is automatically set when a vessel temperature start

VK 7025 Op Man 70-9033 Rev G

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