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VK 7000 7010 Op Man 70-9003 Rev J

1. After all parameters have been entered the Main Menu displays Press MENU to return to the system status screen Main Menu Option 6 Start Program From the Main Menu select option 6 Start Program The Select Start Mode screen displays SELECT START MODE 1 INSTANT START 2 TIME DELAY START 3 SET TEMP START 4 REMOTE START OUTPUT TIME 09 01 05 16 40 22 ELAPSE 000 00 00 Varian Inc Page 56 Operating and Programming VK 7000 7010 Dissolution Apparatus Revision J 01 06 Operator s Manual P N 70 9003 Following is a description of the Select Start Mode screen options Option Function 1 Instant Start Select option 1 Instant Start to begin an instant start Press RUN to start the program immediately 2 Time Delay Start Select option 2 Time Delay Start to specify when a delayed start will begin Enter the time you want the program to begin in 24 hour format and press ENTER Enter the start date in the appropriate format and press ENTER The system status screen displays The entered start time flashes alternately with the printer on off status and print frequency At any time prior to the scheduled start of the program press CLEAR to cancel the delayed start 3 Set Temp Start Select option 3 Set Temp Start to start the program when AutoTemp determines that all vessels are at the desired temperature Enter the vessel temperature to the nearest 0 1 C and press ENTER
2. 1 Basket Select option 1 Basket to enable basket mode Set the baskets to the proper height in the vessels as discussed in Setting Paddle or Basket Heights with Standard Accessories on page 35 Position the stop ring and raise the drive unit so that the baskets are completely out of the vessels Load the dosage units into the baskets and clip a basket to each shaft Skip to Spindle Speed on page 51 2 Paddle Select option 2 Paddle to enable paddle mode Continue to Dosage Delivery Mode below Dosage Delivery Mode The Select Dosage Delivery Mode screen displays only if your system configuration includes DDM and you select option 2 Paddle on the previous screen The currently selected option is marked with an asterisk SELECT DOSAGE DELIVERY MODE 1 SEQUENTIAL 2 SIMULTANEOUS SELECTED TIME 09 01 05 16 40 22 ELAPSE 000 00 00 Varian Inc Revision J 01 06 VK 7000 7010 Dissolution Apparatus Page 51 P N 70 9003 Operator s Manual Operating and Programming Following is a description of the Select Dosage Delivery Mode screen options Option Function 1 Sequential Select option 1 Sequential to drop the dosage units sequentially with a user defined delay between each drop The Enter Increment Time screen displays Enter the delay value from 1 to 999 seconds and press ENTER 2 Simultaneous Select option 2 Simultaneous to drop all dosage units simul
3. Varian Inc Page 58 VK 7000 7010 Dissolution Apparatus Revision J 01 06 Operating and Programming Operator s Manual P N 70 9003 This page was intentionally left blank except for this message Varian Inc chapters Maintenance and Troubleshooting Periodic 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 painful electric shock Periodic maintenance needs may vary depending on frequency of instrument usage Daily Maintenance See Paddle Basket Shaft Care on page 61 Basket Care on page 62 and Water Bath Acrylic Care on page 63 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 60 VK 7000 7010 Dissolution Apparatus Revision J 01 06 Maintenance and Troubleshooting Operator s Manual P N 70 9003 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 shaf
4. Step 12 Reconnect the limit switch on the left back corner For the VK 7010 also reconnect the DDM cable on the main PCB as well as the power cables from the DDM power supply Step 13 Replace the Phillips head screws and the white snap caps Step 14 Reconnect the power cord and turn on the instrument 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 advance 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 Step 2 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 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 Varian Inc Revision J 01 06 VK 7000 7010 Dissolution Apparatus Page 67 P N 70 9003 Operator s Manual Maintenance and Troubleshooting Step 3 Push down on the right side of the ribbon cartridge marked PUSH and remove the old cartridge Step 4 I
5. Step 4 The top cover is attached with six screws The top center screw on each side panel must be removed as well These eight screws are located under the white plastic caps The white plastic caps must be removed carefully by inserting a thin blade under the edge of the cap Do not force the blade any deeper than 1 16 of an inch under the cap A very slight lift removes the cap and exposes the screw Step 5 Remove the Phillips head screws that are exposed when you remove the snap caps Step 6 Disconnect the limit switch on the left back corner Be sure to replace these connectors when you reassemble the apparatus For the VK 7010 also disconnect the DDM cable on the main PCB as well as the power cables from the DDM power supply Be sure to replace these connectors when you reassemble the apparatus Step 7 Lift the top cover and secure it to the underside of the top plate with clamps Step 8 Inspect the drive belt for unusual wear fraying and tension A small amount of belt material may be observed in the form of black dust or powder on the bottom plate This is normal and no cause for alarm Step 9 Check the spindle motor brushes for wear every three months Varian Inc Page 66 VK 7000 7010 Dissolution Apparatus Revision J 01 06 Maintenance and Troubleshooting Operator s Manual P N 70 9003 Step 10 Remove the clamps securing the top cover to the underside of the top plate Step 11 Replace the top cover
6. 7010 Dissolution Apparatus Page 69 P N 70 9003 Operator s Manual Maintenance and Troubleshooting 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 70 for instructions on turning on and off the PRINT READY command When you 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 oper
7. Other 10 General 12 WEEE Directive 13 Chapter 2 Introduction 15 Conventions Used in this Manual 18 USP Suitability Test 18 USP Physical Parameters 19 Varian Inc Table of Contents Chapter 3 Chapter 4 Setting Up 21 Unpacking the Dissolution Apparatus 21 Drive Unit Setup 22 Quick Key Guide 25 Hidden Key Functions 26 Water Bath and Heater Circulator Setup 26 6 or 8 vessel System Setup 27 12 or 16 vessel System Setup 29 Installing and Centering the Vessels 30 Installing and Centering TruCenter Vessels 31 Installing Paddles Basket Assemblies for VK 7000 7010 33 Installing Paddle Basket Assemblies for VK 7000 7010 E 34 Setting Paddle or Basket Heights with Standard Accessories 35 Centering Verification 37 Installing Dosage Delivery Module Tubes Optional on the VK 7000 39 Installing the Sampling Manifold Optional on the VK 7000 40 Installing AutoTemp Optional on the VK 7000 41 Setting the Baud Rate 42 Filling the Water Bath 43 Setting the Initial Bath Temperature 44 Operating and Programming 45 Main Menu 45 Main Menu Option 3 Set Temperature 47 Main Menu Option 4 Documentation 48 Main Menu Option 5 Write Program 49 Main Menu Option 6 Start Program 55 Main Menu Option 7 Alarms Counter 57 Varian Inc Table of Contents Chapter 5 Chapter 6 Maintenance and Troubleshooting 59 Periodic Maintenance 59 Daily Maintenance 59 Paddle Basket Shaft Care 61 Basket Care 62 Water Bath
8. on page 55 7 Alarms Counter Use this option to set alarms and timers See Main Menu Option 7 Alarms Counter on page 57 Varian Inc Revision J 01 06 VK 7000 7010 Dissolution Apparatus Page 47 P N 70 9003 Operator s Manual Operating and Programming Main Menu Option 3 Set Temperature From the Main Menu select option 3 Set Temperature The Select Temperature Set Mode screen displays SELECT TEMPERATURE SET MODE 1 SET BATH TEMP 2 SET VESSEL TEMP 3 DELAYED BATH HEATING 4 DELAYED VESSEL HEATING Note Cu Options 2 and 4 are available only if AutoTemp is installed on your dissolution apparatus All four options display even if AutoTemp is not installed Following are the Select Temperature Set Mode screen options Option Function 1 Set Bath Temp Select option 1 Set Bath Temp Enter the temperature required for the water bath and press ENTER The status screen displays Press MENU gt 3 to return to the Select Temperature Set Mode screen Note to correct an error press CLEAR and re enter the temperature 2 Set Vessel Temp Select option 2 Set Vessel Temp Enter the desired vessel temperature and press ENTER The Change Temp Diff Of Bath Vessel screen displays Press MENU gt 3 to return to the Select Temperature Set Mode screen Note the temperature differential is the offset between the water bath temperature and the vessel media temperature needed
9. 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 Warning 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 J 01 06 VK 7000 7010 Dissolution Apparatus Page 11 P N 70 9003 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
10. The fuse for the 230 V apparatus is a 2 amp metric 5 mm x 20 mm fuse and for the 115 V apparatus is a 3 amp metric 5 mm x 20 mm fuse Place the new fuse into the holder and insert the fuse holder into the power entry module The holder is keyed and can be inserted only one way Push the fuse holder into the power entry module until both sides snap Replace the power cord Varian Inc Revision J 01 06 P N 70 9003 VK 7000 7010 Dissolution Apparatus Operator s Manual Page 75 Maintenance and Troubleshooting 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 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 Problem Possible Cause Suggested Solution The unit does not respond when main power is ON There is a blown fuse in the rear panel AC line cord receptacle Replace if necessary See Fuse Replacement on page 74 The unit is not plugged into a power outlet Plug the unit into an appropriate power outlet The electrical
11. it stops automatically Caution Do not allow the paddles or basket assemblies to hit the bottoms of the vessels as the drive unit lowers Damage to the vessels could result FIGURE 10 Left Leg of VK 7000 7010 stop ring ____ i r depth spacer for basket t lower safety stop m Step 3 Loosen the chuck on each spindle and carefully lower each paddle or basket assembly until the paddle blade or basket is resting on the bottom of the vessel Tighten each chuck securely Note I gt When using paddle over disk insert the disk in the vessel and set the paddle height to 25 2 mm over the disk Varian Inc Revision J 01 06 VK 7000 7010 Dissolution Apparatus Page 37 P N 70 9003 Operator s Manual Setting Up Step 4 Select either the paddle or basket spacer depending on the apparatus being used Spacers are clearly stenciled Note they are not the same The basket spacer is slightly taller than the paddle spacer see Figure 9 Depth Spacers on page 35 Step 5 Raise the drive unit two or three inches Slide the stop ring up the left leg of the apparatus and clip the spacer onto the leg between the stop ring and the safety stop see Figure 10 Left Leg of VK 7000 7010 on page 36 Slide the spacer down so it rests on top of the safety stop and slide the stop ring down until it rests on top of the spacer Tighten the stop ring thumbscrew to
12. outlet does not have power Check the outlet for electrical current The spindles are not synchronized The drive belt is loose Tighten the drive belt The printer does not print The printer is offline Ensure the printer is online and enabled See Main Menu Option 4 Documentation on page 48 The printer frequency is set to 0 Set the correct printer frequency See Main Menu Option 4 Documentation on page 48 The printer is out of paper Ensure paper is installed in the printer Varian Inc Page 76 Maintenance and Troubleshooting VK 7000 7010 Dissolution Apparatus Operator s Manual Revision J 01 06 P N 70 9003 Problem Possible Cause Suggested Solution The water bath will not heat The heater circulator is not powered on Ensure the heater circulator is powered on The temperature probe is notin the water bath Place the temperature probe in the water bath The water bath temperature is set incorrectly Set the correct water bath temperature See Main Menu Option 3 Set Temperature on page 47 The keypad does not respond to user input The vessel temperatures do not display The keypad is locked The sample manifold is not lowered Press CLEAR gt 2 to unlock the keypad Lower the sample manifold The media temperature is not 30 or higher in at least one vess
13. secure it in place Step 6 Lower the drive unit until it stops automatically The paddles or baskets are set to their USP specified height of 25 2 mm above the bottom of the vessel Note To set the paddle height when using Peak Vessels complete the steps above except ensure you are using peak vessel spacers Spacers are clearly stenciled Note they are not the same The a paddle spacer is higher than the peak vessel spacer See Figure 9 Depth Spacers on page 35 Once complete the paddles are set to their USP specified height of 25 2 mm from the bottom of the vessel 10 mm from the top of the peak Centering Verification To verify the centering of the EaseAlign vessels complete the following steps Step 1 Locate the blue EaseAlign Centering Verification Gauge see Figure 11 EaseAlign Centering Verification Gauge on page 38 Varian Inc Page 38 Setting Up VK 7000 7010 Dissolution Apparatus Revision J 01 06 Operator s Manual P N 70 9003 FIGURE 11 EaseAlign Centering Verification Gauge Step 2 Step 3 Step 4 Step 5 Step 6 Lower the drive unit until the top of the paddle blade or basket is approximately 2 inches 5 cm below the rim of the vessel Place the gauge against the shaft with the shaft resting in the radial cutout Slide the gauge down the shaft until the tapered ends pass through the slots in the EaseAlign centering ring See Figure 6 Ease
14. the spindle assembly Tighten the chuck to hold it in place Varian Inc Page 34 VK 7000 7010 Dissolution Apparatus Revision J 01 06 Setting Up Operator s Manual P N 70 9003 Step 4 Repeat the procedure for the remaining paddles or baskets Leave the drive unit in the UP position Installing Paddle Basket Assemblies for VK 7000 7010 E 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 Step 1 Raise the drive unit to its highest position Step 2 Carefully insert a paddle or basket assembly into each spindle until approximately half of the shaft is above the top of the spindle Step 3 Place a shaft locking ring on the top of each shaft and slide it down until it rests on the shaft collar Step 4 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 in place Step 5 Tighten the set screws using the 7 64 inch T handle Allen wrench provided Leave the drive unit in the fully raised position Varian Inc Revision J 01 06 VK 7000 7010 Dissolution Apparatus Page 35 P N 70 9003 Operator s Manual Setting Up Setting Paddle or Basket Heights with Standard Accessories Use the height spacers to quickly set p
15. to overcome the thermal loss due to the vessel walls To accept the current temperature differential selection option 2 No To change the differential select option 1 Yes Enter the temperature differential to the nearest 0 01 C and press ENTER The normal setting is 0 20 Press MENU to stop the spindles The status screen displays Note to correct an error press CLEAR and re enter the temperature Varian Inc Page 48 Operating and Programming VK 7000 7010 Dissolution Apparatus Revision J 01 06 Operator s Manual P N 70 9003 4 Delayed Vessel Heating Option Function 3 Delayed Bath Select option 3 Delayed Bath Heating Enter the desired water bath Heating temperature and press ENTER Enter the desired start time in 24 hour format and press ENTER Enter the desired start date in the appropriate format and press ENTER The status screen displays Press MENU gt 3 to return to the Select Temperature Set Mode screen Select option 4 Delayed Vessel Heating Enter the desired vessel temperature and press ENTER The Change Temp Diff Of Bath Vessel screen displays Note the temperature differential is the offset between the water bath temperature and the vessel media temperature needed to overcome the thermal loss due to the vessel walls To accept the current temperature differential selection option 2 No To change the differential select option 1 Yes Enter the temperature differential
16. tubing adapters on each of the water bath inlets water bath inlets have deflector screens Secure the tubing clamps Note U gt You can cut the tubing to any length required if the precut pieces are too long Step 6 Step 7 Step 8 Repeat steps 2 5 for the inlet return tubing Locate the two remaining two foot lengths of precut tubing Slip a tubing clamp over one end of each tube and attach one end of each tube to the barbed angle adapters in the bottom drains Secure the tubing clamps Slip a tubing clamp over the other end of each tube and attach the free end of each tube to the straight arms of the plastic T connector supplied and secure the tubing clamps Slip a tubing clamp over the end of the final piece of tubing which has the drain valve connected and attach the free end to the 90 degree branch of the T connector Secure the tubing clamp Do not fill the water bath at this time Installing and Centering the Vessels Step 1 The apparatus is supplied with self centering EaseAlign centering rings EaseAlign centering rings keep the vessel centered at all times without the use of tools and prevent vessels from floating even when they are empty The EaseAlign centering rings are normally shipped in place on the vessel plate Remove the rings from the vessel plate Varian Inc Revision J 01 06 VK 7000 7010 Dissolution Apparatus Page 31 P N 70 9003 Operator s Manual Setting Up
17. water bath Step 2 Turn on the VK 750D Heater Circulator Step 3 Check all connections for leaks Bubbles may appear at the water bath inlet as the air in the system is purged After a few minutes flow into the water bath should be smooth and steady Note oe Though the VK 750D is designed to be self priming it might be necessary to help the priming process in a dry unit To help clear the air hold the unit below the level of the water bath for a minute or two with the rear end up Varian Inc Page 44 VK 7000 7010 Dissolution Apparatus Revision J 01 06 Setting Up Operator s Manual P N 70 9003 Setting the Initial Bath Temperature The water bath temperature can be set via the dissolution apparatus or the VK 750D Once connected via a five pin DIN cable the dissolution apparatus controls the VK 750D and makes programming the heater circulator from its keypad unnecessary See Main Menu Option 3 Set Temperature on page 47 for more information The VK 750D displays a series of dashes instead of the temperature Read the temperature from the dissolution apparatus display screen Refer to the VK 750D Heater Circulator Operator s Manual for further details on how to set the water bath temperature from the VK 750D keypad Although the water bath temperature probe supplied with the system is a high accuracy unit there is a slight differential between the water b
18. wiped clean with a soft cloth or nonabrasive pad every one to three months Note 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 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 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 ca
19. 8 0 875 80 77 0 311 80 20 0 2814 49 0 842 80 78 0 301 70 21 0 2690 50 0 811 30 79 0 292 00 22 0 2572 51 0 781 10 80 0 282 70 23 0 2460 52 0 752 20 Varian Inc Page 74 VK 7000 7010 Dissolution Apparatus Revision J 01 06 Maintenance and Troubleshooting Operator s Manual P N 70 9003 Fuse Replacement A 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 holder is located in the lower section of the power entry module on the rear of the dissolution apparatus Step 1 Step 2 Step 3 Step 4 Step 5 Step 6 Before checking or attempting to replace a fuse remove the power cord from the dissolution apparatus There are two release slots one on the left and one on the right The fuse holder is released by inserting a small screwdriver into one of the slots However two screwdrivers one in each slot may work best A slight application of pressure toward the center of the compartment releases the fuse holder Pull the fuse holder out of the power entry module The fuse is located in the removable holder
20. 9 01 05 16 40 22 ELAPSE 000 00 00 If your apparatus is equipped with the optional automated sampling manifold either interfaced to an automated system such as an online spectrophotometer or as part of a VK 8000 sampling system you can program it to lower and raise the sampling cannulas during the test This feature is especially useful if your system configuration includes instrumentation which does not actually control the dissolution apparatus The currently selected option is marked with an asterisk Varian Inc Revision J 01 06 VK 7000 7010 Dissolution Apparatus Page 55 P N 70 9003 Operator s Manual Operating and Programming Following is a description of the Sample Manifold Auto Control screen options Option Function 1 Enable Select option 1 Enable to display the Manifold Time Pt screen Enter a time in 24 hour format for the sampling manifold to lower the cannulas into the vessels for sampling and press ENTER You can enter up to 30 timepoints The Main Menu displays 2 Disable Select option 2 Disable to stop the manifold from lowering at specific timepoints The Main Menu displays Note You must enter a down time length after programming manifold Ee timepoints Down time length is the duration the manifold remains lowered during the manifold timepoint Enter a value in mm ss format up to 99 59 Ensure the down time is long enough to allow for any removal of samples
21. Acrylic Care 63 Visual Checks 65 Report Center Impact Printer 66 Installing the Cartridge Ribbon 66 Replacing the Paper Roll 67 Toggling Your Printer Online 69 Printer Self Test 69 Printer Configuration 70 Water Bath Temperature Probe Accuracy Test 72 Fuse Replacement 74 Troubleshooting 75 Service and Warranty 77 Exclusions and Limitations 78 Obtaining Warranty Service 78 Warranty Limitations 78 Exclusive Remedies 79 Index 81 Tell Us How We Are Doing 83 Varian Inc Table of Contents This page was intentionally left blank except for this message Varian Inc List of Figures FIGURE 1 FIGURE 2 FIGURE 3 FIGURE 4 FIGURE 5 FIGURE 6 FIGURE 7 FIGURE 8 FIGURE 9 VK 7000 Dissolution Apparatus 17 System Monitor and System Control Panel 23 Lift Down and Lift Up Buttons 24 VK 750D Heater Circulator Rear Panel Connections 27 Barbed angle Tubing Adapter with Flow Deflector 28 EaseAlign Centering Ring 31 TruCenter Vessel Adapter 32 Spindle Assembly 33 Depth Spacers 35 FIGURE 10 Left Leg of VK 7000 7010 36 Varian Inc List of Figures FIGURE 11 EaseAlign Centering Verification Gauge 38 FIGURE 12 DDM Tube Extensions 39 FIGURE 13 Rear Panel 41 Varian Inc chapter1 Safety Practices and Hazards The VK 7000 7010 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 m
22. Align Centering Ring on page 31 The tapered sides of the gauge rest against the inside rim of the vessel The gauge is level in this position indicating the vessel is centered Lift the gauge and rotate it 90 degrees Repeat steps 3 5 fitting the gauge in the remaining two slots on the EaseAlign centering ring Varian Inc Page 39 Revision J 01 06 VK 7000 7010 Dissolution Apparatus Setting Up P N 70 9003 Operator s Manual Installing Dosage Delivery Module Tubes Optional on the VK 7000 Note aJ The VK 7010 is equipped with a factory installed DDM which automates the process of tablet dropping This feature is an optional upgrade for the VK 7000 The solenoids which drop the dosage units are mounted on the underside of the top cover When dropped each dosage unit travels through an acrylic tube which exits the underside of the drive unit and guides the dosage unit into the vessel see Figure 12 DDM Tube Extensions below FIGURE 12 DDM Tube Extensions Drive Unit Extension Connector Spindle DDM Extension Tube CE Refer to Dosage Delivery Mode on page 50 for information on using the DDM Since the module in the VK 7010 is factory installed you only need to install the lower halves of the DDM tubes Varian Inc Page 40 Setting Up VK 7000 7010 Dissolution Apparatus Revision J 01 06 Operator s Manual P N 70 9003 Complete the following st
23. D SPINDLE HOURS TIME 09 01 05 16 40 22 ELAPSE 000 00 00 ALARMS OR HOUR COUNTER 2 BATH TEMP ERROR Following is a description of the Alarms or Hour Counter screen options Option Function 1 Timer Select option 1 Timer to set the timer Enter a duration in hh mm format and press ENTER The Alarms or Hour Counter screen displays Press CLEAR to silence the alarm after it sounds Note the timer is a simple timer you can use to time any interval from 1 minute to 99 59 hours 2 Bath Temp Error Select option 2 Bath Temp Error to set the water bath temperature error alarm Enter the desired acceptable water bath temperature range and press ENTER The Alarms or Hours Counter screen displays If the water bath temperature strays above or below this range the bath temperature alarm sounds Press CLEAR to silence the alarm after it sounds 3 USP Calibration The USP calibration alarm sounds prior to the next scheduled suitability test Select option 3 USP Calibration to set the alarm Enter the date for the next calibration in the appropriate format and press ENTER The Alarms or Hours Counter screen displays Press CLEAR to silence the alarm after it sounds 4 Read Spindle Hours Select option 4 Read Spindle Hours to display the number of hours your spindles have spun Press MENU to exit this screen The Alarms or Hours Counter screen displays Press MENU to return to the Main Menu
24. Step 2 Place each of the vessels on the vessel plate The EaseAlign centering rings have two large holes to accommodate the plastic pegs adjacent to each vessel location on the vessel plate Press one EaseAlign centering ring firmly into each vessel with the alignment fingers inside the vessel See Figure 6 EaseAlign Centering Ring below Step 3 When pushed down securely the vessels are automatically aligned and require no further adjustment FIGURE 6 EaseAlign Centering Ring Holes for plastic pegs Installing and Centering TruCenter Vessels Specially designed TruCenter vessels with magnetic ring flanges can also be used with the VK 7000 7010 The magnetic ring flanges keep the vessel centered at all times without the use of tools and prevent vessels from floating even when they are empty Complete the following steps to install the TruCenter vessels Step 1 Raise the drive unit to its highest position Step 2 Situate the adapters on the vessel plate The adapters have two large holes to accommodate the plastic pegs adjacent to each vessel location on the vessel plate Varian Inc Page 32 Setting Up VK 7000 7010 Dissolution Apparatus Revision J 01 06 Operator s Manual P N 70 9003 FIGURE 7 TruCenter Vessel Adapter Step 3 Step 4 Step 5 Step 6 Press the adapters securely into place Place the vessels on the adapters Press down so the vessels and magnetic ring fla
25. The Change Temp Diff Of Bath Vessel screen displays Note the temperature differential is the offset between the water bath temperature and the vessel media temperature needed to overcome the thermal loss due to the vessel walls To accept the current temperature differential selection option 2 No To change the differential select option 1 Yes Enter the temperature differential to the nearest 0 01 C and press ENTER The normal setting is 0 20 The temperature probes lower into the vessels and continuously monitor the temperature until the selected temperature is reached and the test starts Press MENU to stop the spindles The system status screen displays Note this option is only applicable if your system configuration includes DDM and you have enabled paddle mode 4 Remote Start Output Select option 4 Remote Start Output to send a TTL signal to start another device Enter a delay length of up to 99 hours and 59 minutes Enter 0 if you want to send the signal as soon as the spindles begin turning The Select Start Mode screen displays Press MENU to return to the system status screen Varian Inc Revision J 01 06 VK 7000 7010 Dissolution Apparatus Page 57 P N 70 9003 Operator s Manual Operating and Programming Main Menu Option 7 Alarms Counter From the Main Menu select option 7 Alarms Counter The Alarms or Hour Counter screen displays 1 TIMER 3 USP CALIBRATION 4 REA
26. Use this key sequence to select the printer type Select option 2 Impact Printer The system status screen displays Note do not select option 1 Thermal Printer The printer will not operate correctly CLEAR gt 8 Use this key sequence to select DDM and vessel temperature options To enable DDM select option 1 Enable Dosage Delivery To enable AutoTemp for reading individual vessel temperatures select option 2 Enable Vessel Temp Probe To enable both options select option 3 Both 1 amp 2 To disable both options select option 4 None The system status screen displays CLEAR gt 9 Use this key sequence to select the number of spindles used in your system configuration Select option 1 Six or option 2 Eight The system status screen displays MENU gt 7 gt 6 Use this key sequence to select the model of your instrument Select option 1 VK 7000 or option 2 VK 7010 The system status screen displays Water Bath and Heater Circulator Setup A single water bath which is connected directly to the inlet and outlet of the VK 750D Heater Circulator is used with 6 or 8 vessel systems see 6 or 8 vessel System Setup on page 27 Two dissolution apparatus can be used in conjunction with a single VK 750D Heater Circulator to obtain 12 or 16 vessel versions see 12 or 16 vessel System Setup on page 29 In 12 or 16 vessel setups the output from the heater circulator is split using a Y c
27. 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 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 J 01 06 VK 7000 7010 Dissolution Apparatus Page 63 P N 70 9003 Operator s Manual Maintenance and Troubleshooting Water Bath Acrylic Care Note g 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 7000 7010 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 compatib
28. a computer connected to the RS232 port on the apparatus Option Function 1 Set RPM Select option 1 Set RPM to set the RPM Enter the desired speed between 10 0 and 255 0 and press ENTER The Main Menu displays For speeds of 50 and 100 RPM see 50 100 RPM under Quick Key Guide on page 25 Note to change the speed while the unit is running press MENU gt 1 Enter the new RPM and press ENTER The RPM changes to the new value 2 Set Clock Select option 2 Set Clock to set the clock Enter the date in the appropriate format and press ENTER Enter the time in 24 hour format and press ENTER The Main Menu displays 3 Set Temperature The dissolution apparatus can control the VK 750D Heater Circulator See Main Menu Option 3 Set Temperature on page 47 Note if your unit is equipped with AutoTemp you can specify the required vessel temperature instead of the water bath temperature When you specify a vessel temperature the water bath is heated until the AutoTemp sensors indicate the temperature in all vessels has reached the specified temperature 4 Documentation 5 Write Program Use this options to control the Report Center Printer See Main Menu Option 4 Documentation on page 48 Use this option to program the test parameters See Main Menu Option 5 Write Program on page 49 6 Start Program Use this option to start the test See Main Menu Option 6 Start Program
29. addles and rotating basket assemblies to their USP required height of 25 2 mm from the bottom of the vessel When using the spacers there is no need to insert tools or gauges into the vessels The spacers snap onto the middle left leg under the stop ring of the dissolution apparatus signaling the drive unit to stop and automatically setting paddles or rotating baskets at the proper depth Caution If you are using the 2L VK 7010 in addition to the basket paddle or Peak Vessel spacer ensure the 4 inch spacer is in place on the middle left leg of the apparatus see Left Leg of VK 7000 7010 on page 36 If this spacer is not in place the drive unit can lower too far hitting the vessel plate and damaging the unit FIGURE 9 Depth Spacers depth spacer for basket depth spacer for paddles depth spacer for Peak Vessels Complete the following steps to set paddle or basket heights Step 1 Ensure the drive unit is raised to the highest position and each paddle or rotating baskets assembly is secured in the spindles with approximately half of the shaft above the top of the spindle Varian Inc Page 36 VK 7000 7010 Dissolution Apparatus Revision J 01 06 Setting Up Operator s Manual P N 70 9003 Step 2 Ensure the stop ring on the left middle leg of the apparatus is resting on top of the lower safety stop see Figure 10 Left Leg of VK 7000 7010 below Lower the apparatus drive unit until
30. airing 64 limitations 78 m maintenance 59 monthly maintenance 60 o obtaining warranty service 78 p paddle care 61 paddle heights setting 35 paddle over disk setting paddle height 36 paddle basket shafts installation 33 peak vessel setting paddle height 37 periodic maintenance 59 printer configuration 70 self test 69 toggling online 69 r reader comment form 83 repairing leaking fittings 64 s safety practices 9 sample final vessel temperature 53 sample manifold installing 40 sampling manifold control 54 self test printer 69 service 77 set temperature 47 setting baud rate 42 setting paddle or basket heights 35 setting up the vk 7000 7010 21 setup water bath and heater circulator 26 spindle speed 51 start program 55 t test length 52 troubleshooting 75 trucenter vessels 31 u unpacking 21 usp 41 usp physical parameters 19 usp suitability test 18 v vessel installation 31 vessels installing and centering 30 w warranty 77 warranty limitations 78 water bath and vk 750d heater circulator setup 26 water bath care 63 water bath temperature probe accuracy test 72 water bath filling 43 weekly maintenance 60 write program 49 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 additiona
31. anner not specified by the manufacturer the protection provided by the equipment may be impaired Operation of a VK 7000 7010 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 7000 7010 Dissolution Apparatus Revision J 01 06 Safety Practices and Hazards Operator s Manual P N 70 9003 Electrical Hazards 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
32. ath temperature and the temperature inside the vessels This is due to the heat transfer characteristics of glass and plastic vessels The Dissolution Systems Service Department suggests using a NIST traceable calibrated thermometer to determine the water bath temperature setting which generates the desired in vessel temperature For example set the water bath temperature to 37 4 C to achieve an in vessel temperature of 37 0 C This 0 4 degree differential is typical but you should calibrate the temperature at setup and periodically thereafter to ensure accuracy of the in vessel temperature Varian Inc chapter4 Operating and Programming Warning This is a rotating apparatus Keep hair and loose clothing away from the spindles Main Menu From the system status screen press MENU The Main Menu displays MAIN MENU 4 DOCUMENTATION 1 SET RPM 5 WRITE PROGRAM 2 SET CLOCK 6 START PROGRAM 3 SET TEMPERATURE 7 ALARMS COUNTER Varian Inc Page 46 VK 7000 7010 Dissolution Apparatus Revision J 01 06 Operating and Programming Operator s Manual P N 70 9003 S ee Note Toggle between the Main Menu and the status screen by pressing MENU After 45 seconds of inactivity the status screen displays The Main Menu can be accessed even if a program is running Several of the selections can be changed while the unit is functioning Most selections can be queried and changed via
33. ation Step 6 The printer is ready to resume normal operation Varian Inc Page 70 VK 7000 7010 Dissolution Apparatus Revision J 01 06 Maintenance and Troubleshooting Operator s Manual P N 70 9003 Printer Configuration Note The printer configuration is set by the factory This procedure Ie should be performed only if the printer displays erroneous characters Contact the Dissolution Systems Service Department for assistance if necessary Step 1 Step 2 Step 3 Step 4 Turn off the dissolution apparatus Press and hold the printer toggle switch in the OnLine Off Line position while turning on the instrument Hold the printer toggle switch in the OnLine Off Line position for six seconds after the instrument is turned on then release the switch The printer should print SETUP MENU and CONFIGURE NEXT OK If this message does not print repeat steps 1 through 3 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
34. ave TAY VK 7000 7010 Dissolution Apparatus Operator s Manual P N 70 9003 January 2006 Revision J 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 7000 7010 Dissolution Apparatus Operator s Manual Part Number 70 9003 Revision J Printed in the United States of America The following terms are trademarks of Varian Inc TM Practical Solutions e Benchsaver BIO DIS III QA and QAII e Enhancer Cell e TruCenter Full Flow Filters VanKel e Peak Vessel VKE All other trademarks are the property of their respective owners Varian Inc 13000 Weston Parkway Cary North Carolina 27513 2250 800 229 1108 919 677 1108 Fax 919 677 1138 www varianinc com ap CN VARIAN Copyright c 1999 2006 by Varian Inc Table of Contents Chapter 1 Safety Practices and Hazards 9 Electrical Hazards 10
35. cohol 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 damage 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 J 01 06 VK 7000 7010 Dissolution Apparatus Page 65 P N 70 9003 Operator s Manual Maintenance and Troubleshooting Visual Checks 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 power to the instrument Step 2 Lower the drive unit to the full down position Step 3 Turn off power to the instrument and remove the power cord
36. ds and many other factors Varian Inc Page 19 VK 7000 7010 Dissolution Apparatus Introduction Revision J 01 06 Operator s Manual P N 70 9003 USP Physical Parameters In addition to the Apparatus Suitability Test several physical parameters must be monitored such as shaft wobble centering speed and shaft verticality A Certificate of Compliance is included with all dissolution apparatus Contact the Dissolution Systems Service Department for more information on USP Physical Parameters Varian Inc Page 20 VK 7000 7010 Dissolution Apparatus Revision J 01 06 Introduction Operator s Manual P N 70 9003 This page was intentionally left blank except for this message Varian Inc Chapter 3 Setting Up Unpacking the Dissolution Apparatus Follow these steps to safely unpack your apparatus and accessories Step 1 Open each carton and check the contents for damage which may have occurred during shipping 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 Step 2 Carefully remove the apparatus accessory kit and heater circulator from their shipping cartons Warning Because of its heavy weight two people should lift the apparatus Do not lift the apparatus by the drive unit Lift by holding th
37. e 1 4 inch phone plug Step 3 Refer to the following table to find the resistance value of the probe at the known bath temperature Temperatures between the values listed may be interpolated Step 4 Probes are interchangeable and manufactured with a tolerance of 0 2 C Probes found to be outside the tolerance of 0 2 C should be replaced Varian Inc Revision J 01 06 VK 7000 7010 Dissolution Apparatus Page 73 P N 70 9003 Operator s Manual Maintenance and Troubleshooting Temp Resistance Temp Resistance Temp Resistance C Ohms C Ohms C Ohms 5 0 9530 24 0 2354 53 0 724 50 4 0 9046 25 0 2252 54 0 697 90 3 0 8586 26 0 2156 55 0 672 50 2 0 8151 27 0 2064 56 0 648 10 1 0 7741 28 0 1977 57 0 624 80 0 0 7355 29 0 1894 58 0 602 40 1 0 6989 30 0 1815 59 0 580 90 2 0 6644 31 0 1739 60 0 560 30 3 0 6319 32 0 1667 61 0 540 50 4 0 6011 33 0 1599 62 0 521 50 5 0 5719 34 0 1533 63 0 503 30 6 0 5444 35 0 1471 64 0 485 80 7 0 5183 36 0 1412 65 0 469 00 8 0 4937 37 0 1355 66 0 452 90 9 0 4703 38 0 1301 67 0 437 40 10 0 4482 39 0 1249 68 0 422 50 11 0 4273 40 0 1200 69 0 408 20 12 0 4074 41 0 1152 70 0 394 50 13 0 3886 42 0 1107 71 0 381 20 14 0 3708 43 0 1064 72 0 368 50 15 0 3539 44 0 1023 73 0 356 20 16 0 3378 45 0 983 80 74 0 344 50 17 0 3226 46 0 946 20 75 0 333 10 18 0 3081 47 0 910 20 76 0 322 30 19 0 2944 4
38. e and Troubleshooting Operator s Manual P N 70 9003 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 printer 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 Revision J 01 06 VK 7000
39. e legs or vessel plate Use care the tracks on the inside of the front legs can cut hands Varian Inc Page 22 VK 7000 7010 Dissolution Apparatus Revision J 01 06 Setting Up Operator s Manual P N 70 9003 Step 3 Remove cushioning material and tape you will not be able to remove the cushion between the drive unit and vessel plate until the power is turned on If any item is missing contact the Dissolution Systems Service Department or your local representative for replacements Step 4 Place the apparatus and heater circulator on a clean dry and level section of the bench Warning The electrical connection at the back of the apparatus is the primary disconnect for the instrument The apparatus should be positioned to allow accessibility to the power cords for easy disconnection Drive Unit Setup Step 1 Ensure the power switch on the left side panel is in the OFF position Step 2 Connect the power cord between the receptacle on the drive unit rear panel and an outlet of the appropriate voltage Warning Ensure the apparatus is configured for the voltage available in your laboratory The electrical connection at the back of the apparatus is the primary disconnect for the instrument Varian Inc Revision J 01 06 VK 7000 7010 Dissolution Apparatus Page 23 P N 70 9003 Operator s Manual Setting Up FIGURE 2 System Monitor and System Control Panel Step 3 Tur
40. e 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 80 VK 7000 7010 Dissolution Apparatus Revision J 01 06 Service and Warranty Operator s Manual P N 70 9003 This page was intentionally left blank except for this message Varian Inc Index a acrylic care 63 alarms counter 57 autotemp installing 41 b basket care 62 basket heights setting 35 basket shaft care 61 bath temperature 51 baud rate setting 42 c cartridge ribbon 66 conventions 18 d documentation 48 dosage delivery mode 50 dosage delivery module tubes installing 39 drive unit setup 22 e exclusions 78 exclusive remedies 79 f figure ddm tube extensions 39 lift down and lift up buttons 24 rear panel 41 spindle and chuck 33 vk 7010 dissolution testing station 17 vk 750d rear panel connections 27 final spin 52 fuse replacement 74 h hazards 9 hidden key functions 26 Varian Inc Index i initial bath temperature setting 44 installing and centering the vessels 30 installing paddle basket shafts 33 installing the printer cartridge ribbon 66 installing trucenter vessels 31 introduction 15 k key guide 25 l leaking fittings rep
41. el Heat the water bath to a temperature greater than 30 Varian Inc Chapter 6 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 Department 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 78 VK 7000 7010 Dissolution Apparatus Revision J 01 06 Service and Warranty Operator s Manual P N 70 9003 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 imprope
42. eps to install the DDM tube extensions Step 1 Step 2 Step 3 Step 4 Insert the threaded end of a DDM tube extensions into the fitting adjacent to the spindle on the underside of the drive unit at vessel position 1 While holding the extension connector under the drive unit carefully turn the tube extension clockwise until secure but do not over tighten Place a DDM compatible evaporation cover over the vessel Ensure the semicircular cutout for the DDM tube extension is positioned under the end of the extension tube Repeat steps 1 3 for each vessel position Installing the Sampling Manifold Optional on the VK 7000 Step 1 Step 2 Step 3 Step 4 Locate the two metal guide shafts that hold the ends of the manifold in place Insert the guide shafts in the holes on the bottom cover of the dissolution apparatus drive unit located between the left set of spindles and right set of spindles Screw them securely in place Locate the internal drive shaft that protrudes through the middle of the bottom cover of the dissolution apparatus drive unit Attach the extension bar Slide the manifold onto the drive shaft extension and guides until the bottom of the drive shaft extension is relatively flush with the underside of the manifold assembly Tighten the screw on the manifold block with an Allen wrench to secure the manifold to the drive shaft Varian Inc Revision J 01 06 VK 7000 7010 Dissolution A
43. er for this configuration is not in place the drive unit can lower too far hitting the vessel plate and damaging the unit FIGURE 3 Lift Down and Lift Up Buttons uFT Note lt gt Safety microswitches located above and below the drive unit turn off the lift motor automatically when it reaches its maximum travel An adjustable lower stop actuates the lower switch Step 5 Remove the cushioning material between the drive unit and vessel plate Step 6 Check the level of the instrument by placing the circular 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 rubber foot on the bottom of each leg is adjustable Adjust the feet until the bubble in the level is in the center circle at all four check points Varian Inc Revision J 01 06 VK 7000 7010 Dissolution Apparatus Page 25 P N 70 9003 Operator s Manual Setting Up Caution Do not place items on top of the drive unit Damage to the items or drive unit could result Quick Key Guide See Figure 2 System Monitor and System Control Panel on page 23 The following is a description of the front panel options Panel Keys Function LIFT Press and hold LIFT A to raise the drive unit Press and hold LIFT V to lower the drive unit Release the button when the drive unit is in the appropr
44. iate position The drive unit stops automatically when it reaches the highest position or the lowest position based on the stop ring on the left leg of the dissolution apparatus PROBES If your dissolution apparatus is equipped with the automated sampling manifold press PROBES A or PROBES to raise or lower the manifold respectively 50 100 RPM Since paddles are usually run at 50 RPM and baskets at 100 RPM a hotkey on the keypad lets you toggle between the two preset choices The unit must be stopped and the status screen displaying to change the setting Press the hotkey until the speed you need is indicated on both the graphics display and the LED speed display Press RUN to start the spindles MENU Press MENU to display to the Main Menu CLEAR Press CLEAR to instantly clear an entry ENTER After entering any input press ENTER to complete the process STOP Press STOP to pause or abort the present program RUN To manually begin operations that were not programmed to delay start press RUN Varian Inc Page 26 Setting Up VK 7000 7010 Dissolution Apparatus Revision J 01 06 Operator s Manual P N 70 9003 Hidden Key Functions Key Sequence Function CLEAR gt 5 Use this key sequence to select the date display style Select option 1 American Style for mm dd yy or option 2 European Style for dd mm yy The system status screen displays CLEAR gt 6
45. ibed European Norm EN standards Varian Inc Revision J 01 06 VK 7000 7010 Dissolution Apparatus Page 13 P N 70 9003 Operator s Manual Safety Practices and Hazards 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 cTUVus U S and Canadian Product Approvals The VK 7000 7010 has been designed to comply with North American safety requirements This product has been tested and certified for the North American market by TUV Rheinland of North America Inc The TUVus mark signifies that this product has been tested to U S standards and certified for the U S market The cTUV mark signifies that this product has been tested to Canadian standards and certified for the Canadian market When the two marks are coupled the cTUVus mark signifies that this product has been tested to standards and certified for both markets WEEE Directive All Varian products that are subject to the WEEE directive shipped after August 13 2005 are compliant with the WEEE marking requirement
46. l 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 1138 Always feel free to telephone us to discuss your comments at 1 800 229 1108 VK 7000 7010 Dissolution Apparatus Operator s Manual P N 70 9003 Revision J
47. le with PETG and acrylic The flow paths in the VK 750D 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 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 Vinegar 5 Glacial Acetic Acid e Ethyl alcohol maximum 10 Varian Inc Page 64 VK 7000 7010 Dissolution Apparatus Revision J 01 06 Maintenance and Troubleshooting Operator s Manual P N 70 9003 e lsopropyl al
48. n on the dissolution apparatus The red LEDs on the system control panel illuminate The initial status screen displays for three seconds VANKEL TECHNOLOGY GROUP VK 7010 PROGRAM VER x xx S N 1 4000 1000 TIME 09 01 05 15 58 33 ELAPSE 000 00 00 The firmware version program ver displays This is the only time the firmware version level displays Record the number below and refer to it if you need to call the Dissolution Systems Service Department Firmware version After three seconds the system status screen displays RPM SET 100 0 MANUAL ACTUAL 000 0 BATH TEMP SET 37 0 C ACTUAL 37 1 C START TIME 12 15 34 PRINTER ON 000m TIME 09 01 05 12 15 47 ELAPSE 000 00 00 Varian Inc Page 24 VK 7000 7010 Dissolution Apparatus Revision J 01 06 Setting Up Operator s Manual P N 70 9003 Step 4 Press and hold LIFT A The drive unit moves up until you release the button or the drive unit reaches the highest position Press LIFT A twice in rapid succession to automatically lift the drive unit to its highest position Press LIFT A or V to cancel the automatic lift For safety reasons the drive unit does not lower automatically You must keep your finger on the button to lower the unit Caution If you are using the 2L VK 7010 ensure the 4 inch spacer is in place on the middle left leg of the apparatus see Left Leg of VK 7000 7010 on page 36 If the appropriate spac
49. nd of the short length of tubing Carefully place this end of the tubing over the connector labeled OUTLET on the VK 750D rear panel Slide it on until it meets the rear panel Step 5 Slide the clamp toward the end until it is over the outlet connector then tighten This ensures a leak free connection Caution Do not over tighten the tubing clamps Damage to the plastic tubing could result Step 6 Slide another tubing clamp over the other end of the same piece of tubing and place it on the barbed angle adapter installed in the inlet water bath connector The inlet connector is on the left side of the water bath when viewed from the front and has a deflector screen attached on the inside see Figure 5 Barbed angle Tubing Adapter with Flow Deflector below Slide the clamp until it is over the adapter then tighten FIGURE 5 Barbed angle Tubing Adapter with Flow Deflector Step 7 Repeat steps 4 thru 6 with the longer piece of 1 2 inch plastic tubing to connect the VK 750D inlet port to the water bath outlet Varian Inc Revision J 01 06 P N 70 9003 VK 7000 7010 Dissolution Apparatus Page 29 Operator s Manual Setting Up Step 8 Step 9 Plug the supplied water bath temperature probe into the jack on the dissolution apparatus rear panel labeled BATH TEMP Place the end of the temperature probe through the small hole in the vessel plate behind the vessel hole in the rear right side Do no
50. nges fit securely in place and are flush with the adapters Twist the vessels slightly until the magnets in the ring flanges make contact with the magnets in the adapters The vessels are automatically centered and require no further adjustment Caution Heat over 65 C can damage the plastic of the magnetic ring flange of the TruCenter vessels Varian Inc Revision J 01 06 VK 7000 7010 Dissolution Apparatus Page 33 P N 70 9003 Operator s Manual Setting Up Installing Paddles Basket Assemblies for VK 7000 7010 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 Follow these steps to install the paddles or rotating basket assemblies Step 1 Raise the drive unit to its highest position Step 2 Loosen the chuck on one of the spindle assemblies see Figure 8 Spindle Assembly below by turning it counterclockwise Carefully insert the end of the paddle or basket shaft with basket attached into the spindle assembly Because the shaft is held very firmly it could be necessary to use moderate force FIGURE 8 Spindle Assembly jt Collet CD Spring Clip Q Bevel Washer O O ring Cup Croo O ring Chuck Step 3 Slide the paddle or basket shaft approximately six inches into
51. nstall 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 Step 5 Turn the cartridge knob marked by an arrow clockwise to stretch the ribbon taut Step 6 Replace the cover Step 7 Toggle the printer online by pressing the printer toggle switch to the OnLine Off Line position The Ready LED illuminates Step 8 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 Step 4 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 Using scissors cut the paper feeding to the printer and remove the paper roll Varian Inc Page 68 VK 7000 7010 Dissolution Apparatus Revision J 01 06 Maintenanc
52. onnector and sent to each water bath simultaneously The outputs from the water baths are recombined using a second Y connector To ensure identical fill levels in both water baths the bottom drains are also connected Varian Inc Revision J 01 06 VK 7000 7010 Dissolution Apparatus Page 27 P N 70 9003 Operator s Manual Setting Up 6 or 8 vessel System Setup Step 1 The PETG water bath is mounted under the vessel plate at the factory Ensure it is tightly mounted directly underneath it If necessary tighten the corner clamps Step 2 Locate the VK 750D tubing kit The kit contains two lengths of 1 2 inch plastic tubing one long one short and four tubing clamps Caution Hand tighten the barbed connectors onto the bulkhead fittings Over tightening could damage the water bath and fitting and cause leakage Step 3 The VK 750D Heater Circulator has two liquid ports on its rear panel see Figure 4 VK 750D Heater Circulator Rear Panel Connections below The inlet is connected to the water bath outlet and the outlet is connected to the water bath inlet FIGURE 4 VK 750D Heater Circulator Rear Panel Connections INPUT TEMP a RS232 SIGNAL PROBE BNA eons ii OFF OUT IN i OUTLET INLET E O O Varian Inc Page 28 VK 7000 7010 Dissolution Apparatus Revision J 01 06 Setting Up Operator s Manual P N 70 9003 Step 4 Slip a tubing clamp over one e
53. ot measure the initial vessel temperature when using baskets The Sample Initial Vessel Temperature screen does not display If your system configuration includes AutoTemp and you have enabled paddle mode the Sample Initial Vessel Temperature screen displays Select whether or not to sample and Varian Inc Page 53 Revision J 01 06 VK 7000 7010 Dissolution Apparatus Operating and Programming P N 70 9003 Operator s Manual record the vessel temperatures at the beginning of the run The in vessel readings are captured on the Report Center printout The currently selected option is marked with an asterisk SAMPLE INITIAL VESSEL TEMPERATURE 1 YES 2 NO SELECTED TIME 09 01 05 16 40 22 ELAPSE 000 00 00 Following is a description of the Sample Initial Vessel Temperature screen options Option Function 1 Yes Select option 1 Yes to program the temperature probes to lower into the vessels at the beginning of the run and read the initial vessel temperatures The Report Center Printer prints the initial in vessel readings 2 No Select option 2 No to program the temperature probes not to lower into the vessels at the beginning of the run and read the initial vessel temperatures Note L_ gt The vessel temperatures display on the system status screen only when the media temperature is 30 C or higher in at least one vessel Sample Final Ve
54. peed water bath temperature and optionally vessel temperatures Printouts are on plain paper which will not fade or discolor over time or with exposure to chemical fumes The VK 7000 and the VK 7010 are supplied with the standard VK 750D Heater Circulator The heater circulator is controlled by the dissolution apparatus The VK 750D runs quietly and efficiently without vibration which could affect dissolution results The dissolution apparatus comes with all accessories needed for proper function e Molded PETG water bath e VK 750D Heater Circulator e USP paddles or rotating basket assemblies e USP glass or plastic 1000 mL vessels e Complete set of alignment tools to ensure full USP compliance 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 Varian Inc Revision J 01 06 VK 7000 7010 Dissolution Apparatus Page 17 P N 70 9003 Operator s Manual Introduction These features are standard on the VK 7010 and optional on the VK 7000 e Dosage Delivery Module e AutoTemp Vessel Temperature Sensing System e Automated Sampling Manifold FIGURE 1 VK 7000 Dissolution Apparatus 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
55. pparatus Page 41 P N 70 9003 Operator s Manual Setting Up Step 5 Prior to analysis verify that the positions of the sampling cannula tips conform to the proper sampling position per USP Installing AutoTemp Optional on the VK 7000 Note I _ The VK 7010 is equipped with AutoTemp to measure and record the temperature of the medium inside each vessel This feature is an optional upgrade for the VK 7000 Temperature readings can be taken before after and periodically during a run Readings are displayed on the status screen and printed on the built in Report Center Printer Refer to Main Menu Option 3 Set Temperature on page 47 for information on using AutoTemp Complete the following steps to install AutoTemp Step 1 Attach one end of the nine pin coiled cable to the AutoTemp box at the rear of the sampling manifold Step 2 Attach the other end of the nine pin coiled cable into the corresponding communication port labeled VESSEL TEMP located on the dissolution apparatus rear panel Refer to the diagram of the dissolution apparatus rear panel below FIGURE 13 Rear Panel START START HEATER SAMPLING PERISTALTIC OUTPUT INPUT CIAC MANIFOLD PUMP BATH VESSE ara ieee TEMP PROBES RS232 DOSAGE DELIVERY MULTI PORT BNI MODULE VALVE Varian Inc Page 42 VK 7000 7010 Dissolution Apparatus Revision J 01 06 Setting Up Operator
56. qualified or Varian authorized service engineers Varian Inc Page 18 VK 7000 7010 Dissolution Apparatus Revision J 01 06 Introduction Operator s Manual P N 70 9003 Conventions Used in this Manual e ltems you are asked to press are in bold For example press 1 on the keypad e Key sequences you are asked to press appear like this MENU gt 4 Note Remember to return the warranty card supplied with this manual Completing and returning the card ensures your right to __ gt 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 USP Suitability Test Before initial use of any dissolution instrument and periodically thereafter the USP requires that you run an Apparatus Suitability Test with both disintegrating and non disintegrating USP Dissolution Calibrators These calibrator tablets are available from the USP at the following address USP NF Reference Standards 12601 Twinbrook Parkway Rockville MD 20852 301 881 0666 Complete instructions come with the calibrator tablets Calibration tests can be very sensitive to factors such as paddle or vessel misalignment vessel shape vibration of the system age of the calibrator tablets and reference standar
57. r example 005 indicates 5 minutes and press ENTER The Report Center Control screen displays Note the printout frequency displays next to PRINTER ON on the system status screen 5 Set Printout ID Select option 5 Set Printout ID Enter the unit identification number up to five digits and press ENTER The Report Center Control screen displays Note the default printout identification number is 12345 6 Set Com Port ID Select option 6 Set Com Port ID Enter a communication port identification number and press ENTER The Select Com Port Baud Rate screen displays Select option 4 9600 Baud The Report Center Control screen displays Note this option is useful when more than one unit is on the same serial communication loop Press MENU to return to the Main Menu Main Menu Option 5 Write Program From the Main Menu select option 5 Write Program Each of the following sections are individual screens that display in sequence Varian Inc Page 50 VK 7000 7010 Dissolution Apparatus Revision J 01 06 Operating and Programming Operator s Manual P N 70 9003 Select Paddle Basket Mode The Select Basket or Paddle screen displays The currently selected option is marked with an asterisk SELECT BASKET OR PADDLE 1 BASKET 2 PADDLE SELECTED TIME 09 01 05 16 40 22 ELAPSE 000 00 00 Following is a description of the Select Basket or Paddle screen options Option Function
58. r 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 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 Page 79 Revision J 01 06 VK 7000 7010 Dissolution Apparatus Service and Warranty P N 70 9003 Operator s Manual Exclusive Remedies The remedies provided herein are the customer s sole and exclusive remedies In no event shall Varian Inc or its representatives b
59. re Most operating parameters are programmable including spindle speed test length vessel temperature and test start times The Dosage Delivery Module DDM can be easily programmed to operate in either simultaneous or sequential mode with up to 99 minutes between drops When using rotating baskets Apparatus 1 you can program a run and preload your sample dosages before starting the test At the specified start time the drive unit automatically lowers the baskets into the vessels to the proper depth Varian Inc Page 16 VK 7000 7010 Dissolution Apparatus Revision J 01 06 Introduction Operator s Manual P N 70 9003 AutoTemp measures and records the temperature of the medium inside each vessel Temperature readings can be taken before after and periodically during a run if desired Readings display on the status screen and can be printed on the built in Report Center Impact Printer You can monitor the vessel temperatures and signal the internal DDM to begin the test run once all vessel temperatures are within USP guidelines The built in Report Center Printer provides a complete report either at the end of a test or on demand which includes instrument identification number date time set temperature print time elapsed time spindle speed and water bath temperature Units equipped with AutoTemp also print vessel temperatures Printouts obtained at preprogrammed time intervals include print time elapsed time spindle s
60. re 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 62 VK 7000 7010 Dissolution Apparatus Revision J 01 06 Maintenance and Troubleshooting Operator s Manual P N 70 9003 bump 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
61. s 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 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 7000 7010 Dissolution Apparatus Revision J 01 06 Safety Practices and Hazards Operator s Manual P N 70 9003 This page was intentionally left blank except for this message Varian Inc chapter2 Introduction Note This manual applies to the VK 7000 and the VK 7010 The VK 7010 comes complete with all the features of a VK 7000 as well as the DDM and AutoTemp features dE The VK 7000 7010 is designed for dissolution testing of a variety of pharmaceutical compounds including tablets capsules transdermal patches and membranes It can be configured as USP Apparatus 1 2 5 or 6 The front panel displays the status screen during a run providing full information on spindle speed elapsed time water bath temperature and mo
62. s Manual P N 70 9003 Setting the Baud Rate Note a a The baud rate must be set to 9600 to ensure proper functioning of the AutoTemp Vessel Temperature Sensing System Complete the following steps to change the baud rate Step 1 Step 2 Step 3 Step 4 Step 5 Step 6 Press MENU The Main Menu displays Select option 4 Documentation The Documentation screen displays Select option 6 Set Com Port ID Enter the communication port identification number and press ENTER The Select Com Port Baud Rate screen displays Select option 4 9600 Baud Press MENU to return to the Main Menu Varian Inc Revision J 01 06 VK 7000 7010 Dissolution Apparatus Page 43 P N 70 9003 Operator s Manual Setting Up Filling the Water Bath Step 1 Remove one vessel and set it aside Pour ultrapure water through the hole in the vessel plate Fill the water bath 3 4 full to allow for displacement by the vessels refer to the sticker on the water bath for the appropriate fill level You can also fill through the bottom drain valve if you have a pressurized ultrapure water hose Note If possible preheat the water to speed achievement of the desired water bath temperature Use ultrapure water whenever possible 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 to construct the
63. ssel Temperature The Sample Final Vessel Temperature screen displays Select whether or not to sample and record the vessel temperatures at the end of the test The in vessel readings are captured on the Report Center printout The currently selected option is marked with an asterisk SAMPLE FINAL VESSEL TEMPERATURE 1 YES 2 NO SELECTED TIME 09 01 05 16 40 22 ELAPSE 000 00 00 Varian Inc Page 54 VK 7000 7010 Dissolution Apparatus Revision J 01 06 Operating and Programming Operator s Manual P N 70 9003 Following is a description of the Sample Final Vessel Temperature screen options Option Function 1 Yes Select option 1 Yes to program the temperature probes to lower into the vessels at the end of the programmed test length or after the final spin and read the final vessel temperatures The Report Center Printer prints the final in vessel readings 2 No Select option 2 No to program the temperature probes not to lower into the vessels at the end of the programmed test length or after the final spin and read the final vessel temperatures Note Op The vessel temperatures display on the system status screen only when the media temperature is 30 C or higher in at least one vessel Sampling Manifold Control The Sample Manifold Auto Control screen displays SAMPLE MANIFOLD AUTO CONTROL 1 ENABLE 2 DISABLE SELECTED TIME 0
64. t fill the water bath at this time Plug one end of the five pin DIN cable into the jack on the VK 750D rear panel labeled INPUT SIGNAL and the other end of the cable into the jack on the rear of the dissolution apparatus labeled HEATER CIRC The VK 750D uses the temperature measured by the apparatus to control the water bath temperature 12 or 16 vessel System Setup Step 1 Step 2 Step 3 Step 4 The PETG water bath is mounted under the vessel plate at the factory Ensure it is tightly mounted directly underneath it Locate one of the precut two foot lengths approximate of tubing from the tubing kit Slip a tubing clamp over one end of the tubing and attach it to the connector labeled OUTLET on the VK 750D rear panel Slide the tube on until it meets the rear panel and secure the tubing clamp Slip another tubing clamp over the other end of the same piece of tubing and attach it to the straight branch of one of the supplied Y connectors Secure the tubing clamp Locate two of the precut seven foot lengths approximate of tubing Slip a tubing clamp over each tube and attach one end of each tube to the two remaining branches of the Y connector Secure the tubing clamps Varian Inc Page 30 VK 7000 7010 Dissolution Apparatus Revision J 01 06 Setting Up Operator s Manual P N 70 9003 Step 5 Slip a tubing clamp over the free end of each of the seven foot lengths of tubing and attach a tube to the barbed angle
65. taneously Spindle Speed The following screen displays ENTER RPM 100 0 TIME 09 01 05 16 40 22 ELAPSE 000 00 00 Enter an RPM value between 10 0 and 250 0 and press ENTER RPM values less than 10 RPM are possible but not recommended Water Bath Temperature The following screen displays ENTER SET BATH TEMP 37 4 C TIME 09 01 05 16 40 22 ELAPSE 000 00 00 Enter the desired water bath temperature to the nearest 0 1 C and press ENTER The maximum achievable temperature is 55 C Varian Inc Page 52 VK 7000 7010 Dissolution Apparatus Revision J 01 06 Operating and Programming Operator s Manual P N 70 9003 Test Length The following screen displays ENTER TEST LENGTH ENTER hh mm UP TO 99 59 HOURS TIME 09 01 05 16 40 22 ELAPSE 000 00 00 Enter the desired length of the test in hh mm format and press ENTER Final Spin at 250 RPM The following screen displays FINAL SPIN AT 250RPM 00 00 ENTER mm ss UP TO 99 59 MINUTES TIME 09 01 05 16 40 22 ELAPSE 000 00 00 Enter the length of time in mm ss format for the spindles to run at 250 RPM at the end of the test and press ENTER For example to add a 2 minute spin time to the end of a 30 minute test enter 02 00 At minute 30 the spindles speed up to 250 RPM and stop after 2 minutes To end the test without a final spin enter 00 00 Sample Initial Vessel Temperature Note You cann
66. to read if the printer cover is removed Varian Inc Revision J 01 06 P N 70 9003 VK 7000 7010 Dissolution Apparatus Operator s Manual Page 71 Maintenance and Troubleshooting SETUP MENU CONFIGURE CUSTOM CUSTOM MENU PRINT CUSTOM SETUP NEXT OK NEXT OK NEXT OK AUTO SEQ NO NEXT OK ZERO NEXT OK POUND SIGN NEXT OK _ UNDERSCORE NEXT OK ONLINE OFFLINE YES NEXT OK EXT CH SET NO NEXT OK PRINT READY YES NEXT OK PRINT READY NO NEXT OK READY Press NEXT to avoid configuration Press OK to enter custom mode Press NEXT Press OK Press OK Press OK Press OK Press OK Press OK Press NEXT Press OK Your printer is now configured correctly Varian Inc Page 72 VK 7000 7010 Dissolution Apparatus Revision J 01 06 Maintenance and Troubleshooting Operator s Manual P N 70 9003 Water Bath Temperature Probe Accuracy Test The temperature probe can be tested using a high quality voltmeter capable of at least four digit resolution and a water bath of known temperature Both the multi meter and the bath temperature probe or calibrated thermometer must be traceable to a known reference standard such as NIST Step 1 Place the probe into a known temperature water bath and allow several minutes for the probe to equilibrate Step 2 The resistance is measured by attaching the leads of the multi meter to the top and shank of th
67. to the nearest 0 01 C and press ENTER The normal setting is 0 20 Enter the desired start time in 24 hour format and press ENTER Enter the desired start date in the appropriate format and press ENTER The status screen displays Press MENU gt 3 to return to the Select Temperature Set Mode screen Press MENU to return to the Main Menu Main Menu Option 4 Documentation From the Main Menu select option 4 Documentation to control the Report Center Printer The Report Center Control screen displays 1 ON 2 OFF 3 INSTANT PRINT 4 PRINTOUT FREQUENCY 5 SET PRINTOUT ID 6 SET COM PORT ID REPORT CENTER CONTROL Varian Inc Revision J 01 06 VK 7000 7010 Dissolution Apparatus Page 49 P N 70 9003 Operator s Manual Operating and Programming Following are the Report Center Control screen options Option Function 1On Select option 1 On to enable the Report Center Printer The Main Menu displays 2 Off Select option 2 Off to disable the Report Center Printer The Main Menu displays 3 Instant Print Select option 3 Instant Print to print all programmed documentation Selecting this option does not affect regular periodic printouts during a test Note ensure the Report Center Printer is turned on and enabled 4 Printout Frequency Select option 4 Printout Frequency to set the time between printing documentation Enter the number of minutes from 1 to 999 in mmm format fo
68. ts 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 61 Basket Care on page 62 and Water Bath Acrylic Care on page 63 as applicable for additional information on proper maintenance of your equipment e Inspect the water bath and VK 750D 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 61 Basket Care on page 62 and Water Bath Acrylic Care on page 63 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 J 01 06 VK 7000 7010 Dissolution Apparatus Page 61 P N 70 9003 Operator s Manual Maintenance and Troubleshooting e It is recommended that the water bath temperature probe jack is checked for surface corrosion and
69. warnings in this manual are as follows Electrical shock Caution Refer to accompanying documents Read all warnings and cautions carefully and observe them at all times 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 Varian Inc Page 12 VK 7000 7010 Dissolution Apparatus Revision J 01 06 Safety Practices and Hazards Operator s Manual P N 70 9003 Information Symbols Switches main power on Switches main power off Indicates single phase alternating current Indicates the product complies with the requirements of one or more European Union EU directives o Indicates specific equipment meets consensus based YN standards of safety to provide assurance required by c te amet us OSHA that these products are safe for use in the workplace for North America Indicates that this product must not be disposed of as unsorted municipal waste see WEEE Directive on page 13 General CE Compliant Products The VK 7000 7010 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 prescr

VK 7000 7010 Op Man 70-9003 Rev J

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