VK 100 Automated Disintegration Apparatus
Contents
1. Setting up the Water Bath Step 1 Ensure the VK 100 is not plugged in Step 2 Place the water bath on the VK 100 with the lower quick connect fitting positioned on the left side of the apparatus Use the locator holes on the water bath and the locator pins on the VK 100 to ensure proper placement Step 3 Locate the two tubes with quick connect fittings and insert them into the appropriate quick connect fittings on the VK 100 water bath see Figure 2 Water Bath Connections below FIGURE 2 Water Bath Connections Varian Inc Revision F 01 06 VK 100 Automated Disintegration Apparatus Page 21 P N 70 9011 Operator s Manual Setup Step 4 Ensure the cover is in place on the water bath with the small hole toward the front Ensure the disintegration beakers are not in place in the cover Step 5 Fill the water bath through any one of the three beaker holes in the cover Note aE Initially fill the water bath no higher than 2 5 inches 6 4 cm from the top to allow for displacement by the beakers when they are inserted Step 6 Check the water bath and all connecting tubing for leaks When satisfied that no leaks are present proceed to Installing the Temperature Probe on page 23 Initial Power Up Electrical Connections Warning Before plugging the VK 100 into any power outlet ensure the instrument is configured for the voltage provided Check the serial number ta2. Page 50 VK 100 Automated Disintegration Apparatus Revision F 01 06 Maintenance and Troubleshooting Operator s Manual P N 70 9011 Troubleshooting The Dissolution Systems Service Department can assist you if you experience problems or questions concerning your VK 100 Automated Disintegration 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 Symptom Probable Cause Possible Solution The displays do not The unit is not connected Connect the VK 100 to a power illuminate to an AC power source outlet The fuse is blown Replace the fuse Dipping does not start Delay is programmed for Reprogram the delay immediately at an the position in question individual position The optional Report Center The printer is disabled Program a print frequency other Printer does not function than 000 Turn on the printer The Ready LED illuminates The Report Center Printer The ribbon is exhausted Replace the ribbon cartridge functions but nothing appears on paper The water does not The tubing or pump is Remove the back panel and inspect circulate clogged the tubing f
3. as the internal tubing fills Wait until the beakers are in place before adding additional water as required to bring the level back to within no more than 2 5 inches of the top of the water bath Replace the cover if removed Varian Inc Revision F 01 06 VK 100 Automated Disintegration Apparatus Page 23 P N 70 9011 Operator s Manual Setup Installing the Temperature Probe The VK 100 is shipped with a factory installed temperature probe inside the heater circulator tank and an external probe to be placed directly in the water bath Both probes are necessary and the temperature readings must remain within 5 C of each other or the VK 100 will not operate If either probe is not functioning or not installed the alarm sounds and the keypad is inactive Note aa a Per a a di LA No installation or positioning is necessary for the internal temperature probe To install the external temperature probe complete the following steps Step 1 Plug the temperature probe into the jack labelled TEMP PROBE on the rear panel Step 2 Insert the metal tip of the probe into the small hole in the water bath cover Step 3 Ensure the small hole and temperature probe are toward the front of the water bath Step 4 Press INT EXT to view the temperature readings for each probe When the external probe reading displays the Ext Temp Probe LED illuminates Varian Inc Page 24 VK 100 Automated Disint
4. e Ensure media is removed and the system is wiped with a clean damp cloth e Lightly spray Lube1 WD40 onto the shafts and run the machine for a few minutes e Change the bath water and add algaecide Every Six Months Maintenance See Water Bath Acrylic Care on page 38 as applicable for additional information on proper maintenance of your equipment e Ensure media is removed and the system is wiped with a clean damp cloth e Lightly spray Lube1 WD40 onto the shafts and run the machine for a few minutes e Change the bath water and add algaecide e Inspect the tubing for algae foreign material and cracks damage Varian Inc Revision F 01 06 VK 100 Automated Disintegration Apparatus Page 37 P N 70 9011 Operator s Manual Maintenance and Troubleshooting Yearly Maintenance See Water Bath Acrylic Care on page 38 as applicable for additional information on proper maintenance of your equipment e Ensure media is removed and the system is wiped with a clean damp cloth e Lightly spray Lube1 WD40 onto the shafts and run the machine for a few minutes e Change the bath water and add algaecide e Inspect the tubing for algae foreign material and cracks damage e Inspect the security of wires and wiring harnesses e Inspect the drive motor ensure no leaking of oil has occurred Disintegration Basket Care 1 All of our disintegration baskets are fabricated entirely of commercial grade acryli
5. s Manual P N 70 9011 SETUP MENU CONFIGURE NEXT OK Press NEXT to avoid configuration CUSTOM NEXT OK Press OK to enter custom mode CUSTOM MENU PRINT CUSTOM SETUP NEXT OK Press NEXT AUTO SEQ NO NEXT OK Press OK ZERO NEXT OK Press OK POUND SIGN NEXT OK Press OK _ UNDERSCORE NEXT OK Press OK ONLINE OFFLINE YES NEXT OK Press OK EXT CH SET NO NEXT OK Press OK PRINT READY YES NEXT OK Press NEXT PRINT READY NO NEXT OK Press OK READY Your printer is now configured correctly Varian Inc Revision F 01 06 VK 100 Automated Disintegration Apparatus Page 49 P N 70 9011 Operator s Manual Maintenance and Troubleshooting Main Power Fuse Replacement Follow these steps to replace the main power fuse Step 1 Unplug the VK 100 Step 2 Press the release tab on the fuse holder in the power connector module with the blade of a small screwdriver or equivalent Step 3 Upon release slide the holder out of the AC power connector Step 4 Remove the old fuse and insert the new fuse Step 5 Slide the holder back into the AC power connector and push until it locks into place Step 6 Reconnect the unit to the AC power source may compromise the safety margin and could result in damage to the instrument or personal injury Warning GN Never replace a fuse with one of a higher amperage rating Doing so Varian Inc
6. ENTER Note It may be necessary to set the water bath temperature up to I gt 0 5 C higher than the desired temperature of the medium in the beakers to compensate for heat loss through the walls of the beakers Varian Inc Page 28 VK 100 Automated Disintegration Apparatus Revision F 01 06 Operation Operator s Manual P N 70 9011 Setting Print Frequency for the Report Center Printer If your VK 100 is equipped with a Report Center Printer and you want an automatic periodic printout of test conditions enable the built in Report Center Printer and indicate the desired automatic print interval To enable the printer press PRINT FREQ Enter the desired auto print interval in mmm format up to 255 minutes and press ENTER To disable the printer enter an auto print frequency of 0 zero and press ENTER Adjusting Basket Height Step 1 Lower the basket to the lowest position and measure the distance from the bottom of the beaker to the bottom of the basket This measurement should be no less than 2 5 cm Step 2 If necessary adjust the basket height by loosening the screw on the basket hanger with an Allen wrench Extend or retract the two parts and tighten the screw to achieve the proper distance of not less than 2 5 cm from the bottom of the beaker FIGURE 5 Basket Adjustment Varian Inc Revision F 01 06 VK 100 Automated Disintegration Apparatus Page 29 P N 70 9011 Operator s Man
7. Operator s Manual P N 70 9011 temperature is displayed continuously on the front panel Both models include accessories Warning The VK 100 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 FIGURE 1 VK 100 Single basket Model Caution Panels or covers that are retained by fasteners which require the use of a tool for removal may be opened only by Varian trained Varian qualified or Varian authorized service engineers Varian Inc Revision F 01 06 VK 100 Automated Disintegration Apparatus Page 17 P N 70 9011 Operator s Manual Introduction Conventions Used in this Manual e Items you are asked to press are in bold For example press ENTER on the key pad e Key sequences you are asked to press appear like this CLEAR gt 0 Note Remember to return the warranty card supplied with this manual Completing and returning the card ensures your right to ne 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 arising concerning your equipment such as upgrades retrofits or regulatory changes Varian Inc Page 18 VK 100 Automated Disintegration Apparatus Revision F 01
8. P N 70 9011 This page was intentionally left blank except for this message Varian Inc chapter2 Introduction Note This manual applies to both the 115 and the 230 voltage VK 100 Read this manual thoroughly before using the VK 100 It contains all information necessary for the safe and reliable operation of this precision instrument The VK 100 is designed to provide versatility and reliability while meeting all current USP testing requirements Its three basket positions can be programmed to dip together or independently allowing up to three different tests to be run at the same time In addition to the standard six tube USP approved basket rack a variety of optional basket racks are available for large and bolus tablets The VK 100 is used for disintegration testing in accordance with current USP requirements The optional built in Report Center Printer provides hard copy documentation of the instrument operation for the highest degree of confidence The VK 100 is available in two models single basket and three basket The three basket apparatus is fully programmable by simply entering the time duration of the test The baskets automatically lift from the beaker at the end of the test in the pass fail mode The three basket model has individual digital time displays for each basket The water bath Varian Inc Page 16 VK 100 Automated Disintegration Apparatus Revision F 01 06 Introduction
9. Page 25 P N 70 9011 Operator s Manual Setup Setting the Date Time Clock If you are using the built in Report Center Printer to document the test conditions you must set the correct date and time This information displays on all printouts To set the date and time complete the following steps Step 1 Press SET CLOCK The position 3 screen flashes the date Step 2 If the date is correct press ENTER Otherwise enter the correct date in mm dd yy format and press ENTER The time flashes Step 3 If the time is correct press ENTER Otherwise enter the correct time in 24 hour format and press ENTER Mounting Baskets and Filling Beakers Step 1 Ensure the water bath cover is in place on the water bath Step 2 Place one two or three 1000 mL USP disintegration beakers through the water bath cover holes so they are suspended in the water bath Step 3 Hold the beaker s down and pour 900 mL of the required disintegration medium in each beaker When full the beakers sit securely in the cover and do not float Step 4 Place one two or three basket racks onto the horizontal basket supports Step 5 Verify the water level in the water bath is above the media level of all beakers If not either add additional water or drain excess water until the proper working level is reached Varian Inc Page 26 VK 100 Automated Disintegration Apparatus Revision F 01 06 Setup Operator s Manual P N 70 9011 Draining the
10. 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 Varian Inc Revision F 01 06 VK 100 Automated Disintegration Apparatus Page 45 P N 70 9011 Operator s Manual Maintenance and Troubleshooting 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 Caution Ensure the roll of paper feeds squarely If it does not the paper can 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 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 posi
11. to telephone us to discuss your comments at 1 800 229 1108 VK 100 Automated Disintegration Apparatus Operator s Manual P N 70 9011 Revision F
12. 06 Introduction Operator s Manual P N 70 9011 This page was intentionally left blank except for this message Varian Inc Chapter 3 Setup Unpacking Your VK 100 Step 1 Step 2 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 Carefully remove the VK 100 from its shipping carton Hold the unit firmly to prevent it from dropping A Warning Hold the unit only by the base Do not hold by the reciprocating shafts to avoid damage Step 3 Check for items which may have come loose during shipping Be sure to remove all parts before discarding or storing the packaging Varian Inc Page 20 VK 100 Automated Disintegration Apparatus Revision F 01 06 Setup Operator s Manual P N 70 9011 Step 4 Place the unit on a clean dry level section of the bench top or table At least four inches of space should be open for the rear panel power connections and for access to the rear panel power switch primary disconnect for the instrument The apparatus should be positioned to allow accessibility to the power cords for easy disconnection Warning GN The electrical connection at the back of the apparatus is the
13. 9011 Operator s Manual Maintenance and Troubleshooting Printer Configuration Note The printer configuration is set by the factory This procedure MUE should be performed only if the printer displays erroneous characters Contact the Dissolution Systems Service Department for assistance if necessary Step 1 Turn off the VK 100 Step 2 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 Step 3 The printer should print SETUP MENU and CONFIGURE NEXT OK If this message does not print repeat steps 1 through 3 Step 4 The printer toggle switch is used to complete the configuration Pressing the left side of the printer toggle switch selects NEXT to advance to the next menu item Pressing the right side of the printer toggle switch selects OK to accept what is stated on this line of the menu item Each time the switch is pressed another part of the menu prints Allow the printer to finish printing before pressing the switch again See the table of commands on the following page gt fe eee nore The printout is easier to read if the printer cover is removed Varian Inc Page 48 VK 100 Automated Disintegration Apparatus Revision F 01 06 Maintenance and Troubleshooting Operator
14. Varian Inc Revision F 01 06 VK 100 Automated Disintegration Apparatus Page 43 P N 70 9011 Operator s Manual Maintenance and Troubleshooting 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 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 Step 2 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 Step 3 Push down on the right side of the ribbon cartridge marked PUSH and remove the old cartridge Step 4 Install the new cartridge If there is already paper in the printer hold the cartridge between your thumb and index finger slide it over the paper and into the printer compartment Ensure the paper is between the ribbon cartridge and the ink ribbon Ensure the ink cartridge is inserted firmly to prevent weak or irregula
15. Water Bath Warning Disconnect the VK 100 from the AC power receptacle before draining the tank Step 1 Disengage the quick connect fitting on the left side of the tank and attach the supplied drain hose Step 2 Open the drain valve and drain the water bath into an appropriate receptacle or sink Step 3 Use a clean paper towel or damp cloth to wipe out the water bath and remove any remaining water from the bottom of the tank Hidden Key Functions The following seldom used operations can be performed by pressing and holding CLEAR and then pressing the number on the keypad and releasing both keys at the same time Refer to Figure 4 VK 100 Keypad on page 24 Key Sequence Function CLEAR gt 0 Use this key sequence to set the communication port identification numbers Enter the identification number and press ENTER CLEAR gt 2 Use this key sequence to enable or disable alarm function CLEAR gt 5 Use this key sequence to toggle between 1 and 2 decimal places for the temperature display Two decimal places is used to calibrate the temperature CLEAR gt 8 Use this key sequence to select the baud rate This key combination toggles among 1200 2400 4800 and 9600 When the correct baud rate displays press ENTER Varian Inc chapter4 Operation Setting Water Bath Temperature To set the water bath temperature press SET TEMP Enter the desired water bath temperature and press
16. ap m8 VARIAN VK 100 Automated Disintegration Apparatus Operator s Manual P N 70 9011 January 2006 Revision F 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 100 Automated Disintegration Apparatus Operator s Manual Part Number 70 9011 Revision F 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 e VanKel e Peak Vessel VK 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 8 VARIAN Copyright c 1999 2006 by Varian Inc Table of Contents Chapter 1 Safety Practices and Hazards 9 Elect
17. c stainless steel and glass 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 acrylic before use If in doubt call the service department for advice before proceeding Do not use 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 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 38 VK 100 Automated Disintegration Apparatus Revision F 01 06 Maintenance and Troubleshooting Operator s Manual P N 70 9011 e lsopropyl alcohol maximum 25 Please store disintegration baskets properly between uses Do not simply place disintegration baskets in a drawer They will be subject to nicks chips and scratches as they bump against each other Place them back into the original shipping containers or other appropriate containers between
18. 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 requirements Such products are marked with the crossed out wheelie bin WEEE symbol shown on page 12 in accordance with European Standard EN 50419 This symbol on the product 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 100 Automated Disintegration Apparatus Revision F 01 06 Safety Practices and Hazards Operator s Manual
19. e or more European Union EU directives Indicates specific equipment meets consensus based standards N of safety to provide assurance required by OSHA that these a Jin 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 100 has been designed to comply with the requirements of the Electro magnetic Compatibility EMC Directive and the Low Voltage Directive LVD of the EU Varian Inc has confirmed that each product complies with the relevant directives by testing a prototype against the prescribed European Norm EN standards Varian Inc Revision F 01 06 VK 100 Automated Disintegration Apparatus Page 13 P N 70 9011 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 100 has been designed to
20. egration Apparatus Revision F 01 06 Setup Operator s Manual P N 70 9011 Water Bath Status LEDs FIGURE 4 VK 100 Keypad HOUR MIN SEC HOUR MIN SEC HOUR MIN SEC SETUP DISPLAY water bath status LEDs The Heater On LED flashes to indicate heater activity When the heater is on continuously as will occur when the water bath is cold the LED remains illuminated As the target temperature is approached the LED flashes indicating the heater is cycling on and off The Over Temp LED illuminates e if the temperature of the water of the water bath exceeds 65 C Check for obstructions and low water if this condition occurs The over temp condition clears automatically when the temperature cools below 55 C Press CLEAR to reset if the temperature is between 55 and 65 C e if the external temperature probe is not in the water bath or is not connected e if the temperature probe readings are more than 5 C higher than the set temperature The Ext Temp Probe LED illuminates when the external temperature probe reading displays in the temperature screen Otherwise the internal probe reading displays Note Op gt If the external temperature probe is not connected the temperature display reads 4 4 This is normal and changes as soon as the probe is installed The Printer On LED illuminates when the Report Center Printer has been enabled Varian Inc Revision F 01 06 VK 100 Automated Disintegration Apparatus
21. ervice Department for assistance Plumbing connections are in the wrong configuration Ensure the lower bulkhead fitting tube on the water bath is connected to the pump inlet Varian Inc Page 52 Maintenance and Troubleshooting VK 100 Automated Disintegration Apparatus Operator s Manual Revision F 01 06 P N 70 9011 Symptom Probable Cause Possible Solution The water circulates but does not heat The temperature setting is incorrect Ensure that the correct set temperature has been input The heater relay is defective Contact the Dissolution Systems Service Department for assistance The heater elements are degraded or faulty For 115 V the resistance is between 10 and 15 ohms For 230 V the resistance is between 48 and 52 ohms Contact the Dissolution Systems Service Department for assistance The main PCB is faulty Contact the Dissolution Systems Service Department for assistance The temperature is not stable or is incorrect The thermistor is faulty Exchange the water bath temperature probe with a known good probe if one is available If one is not available see Water Bath Temperature Probe Accuracy Test on page 41 Instrument requires calibration Contact the Dissolution Systems Service Department for assistance Varian Inc Chapter 6 Service and Warranty The warranty is provided by Va
22. g on the rear panel to confirm the voltage requirement The electrical connection at the back of the apparatus is the primary disconnect for the instrument See Figure 3 VK 100 Rear Panel on page 22 to complete the steps that follow Varian Inc Page 22 Setup VK 100 Automated Disintegration Apparatus Revision F 01 06 Operator s Manual P N 70 9011 FIGURE 3 VK 100 Rear Panel Step 1 Step 2 Step 3 AED m INPUT TEMP SIGNAL PROBE Ensure the power is off Connect the power cord between the AC power connector and an AC power receptacle of the appropriate voltage Turn on the VK 100 The three position screens and the temperature screen on the front panel illuminates immediately You will hear the circulator working as it begins to pump the bath water through the system Bubbles may appear at the water bath inlet as air is expelled from the system Note Make a final check for leaks Allow the circulator to run for five K gt gt gt minutes then check the bath tubing connectors and the bench Step 4 Step 5 area immediately surrounding the apparatus If any water leaks are seen turn off the power immediately and remove the power cord Locate and fix the source of the leak before proceeding Place the disintegration beaker s through the holes in the top cover of the water bath As the water circulates there may be a slight drop in the water bath level
23. guration 47 printer on led 24 printer operation during manual or program operation optional 34 printer self test 46 printer toggling online 45 product approvals 13 r reader comment form 59 repairing leaking fittings 39 S safety practices 9 self test printer 46 service 53 setting the date 25 setting the time 25 setting up the vk 100 19 setting up the water bath 20 single basket operation 29 t temperature probe 23 temperature probe accuracy test 41 troubleshooting 50 Varian Inc ap ms VARIAN Tell Us How We Are Doing We listen to our customers We work hard to make our technical documentation user friendly and to make the information in our manuals easy to retrieve and use We d like you to tell us the kinds of additional information you d find helpful in our documentation Your feedback will be carefully considered when we prepare future editions of this manual This manual should contain the following additional information The most useful thing about this book is This manual would be more helpful if My general impressions of this book are May we contact you regarding your comments YES NO If yes please write your name address and telephone number here Please return this form via mail to Technical Writing Dissolution Systems Varian Inc 13000 Weston Parkway Cary North Carolina 27513 2250 USA Optionally you can return this form via fax at 1 919 677 1550 Always feel free
24. le on page 31 indicates the previously programmed test length for position 2 was 40 minutes 1 To accept the current test length press ENTER 2 To change it enter the new value in hhmmss and press ENTER 3 To disable position 2 enter 000000 and press ENTER In the display the numeral 3 flashes alternating with the previously programmed delay time for position 3 in hhmmss format The delay time is the amount of time between the start of the program and the start of dipping for position 3 For example you may see the following alternating displays POSITION 3 POSITION 3 The above example indicates the previously programmed delay time for position 3 was 10 minutes 1 To accept the current delay time press ENTER 2 To change it enter the new value in hhmmss and press ENTER 3 If no delay is desired enter 000000 and press ENTER In the display the numeral 3 flashes again this time alternating with the previously programmed test length for position 3 For example you may see the following alternating displays POSITION 3 POSITION 3 The above example indicates the previously programmed test length for position 3 was 50 minutes 1 To accept the current test length press ENTER 2 To change it enter the new value in hhmmss and press ENTER 3 To disable position 3 enter 000000 and press ENTER Varian Inc Revision F 01 06 VK 100 Automated Disintegration Apparatus Page 33 P N 70 9011 Operator s Manual Opera
25. leshooting Operator s Manual P N 70 9011 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 Step 2 Step 3 Step 4 Step 5 Step 6 Step 7 Turn off power to the instrument and remove the power cord Remove the six screws located on the right side of the instrument and remove the side cover Inspect the drive belt for unusual wear fraying and tension Check the spindle motor brushes for wear every three months Replace the side cover Replace the Phillips head screws Reconnect the power cord and turn on the instrument Varian Inc Revision F 01 06 VK 100 Automated Disintegration Apparatus Page 41 P N 70 9011 Operator s Manual Maintenance and Troubleshooting 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 known temperature bath Both the voltmeter and the bath temperature 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 voltmeter to the top and shank of the 1 4 inch phone plug Step 3 Refer to the following table to find the re
26. mmediately l Note ai Press STOP to immediately stop all baskets Multi basket Operation There are two benefits of multi basket mode e You can program any combination of baskets to start and stop at exactly the same time This feature allows the VK 100 to function as a conventional two or three basket apparatus e You can program the VK 100 to drop the baskets at staggered times and to remove them at the same time This feature is useful when running different products with different test lengths simultaneously without returning to the apparatus at different times to view the end of each test For example you can position baskets 1 and 3 to start and finish their dip cycles at exactly the same time while position 2 remains idle or baskets 1 and 2 start and finish while position 3 remains idle Alternatively you can have basket 3 start automatically 5 minutes after basket 1 with a test time 5 minutes less than that for basket 1 This causes both baskets to finish at the same time while position 2 remains idle The screen under position 3 acts as the display screen for programming the VK 100 Create a programming sequence as follows Step 1 Press SET PROG In the display the numeral 1 flashes alternating with the previously programmed test length for that position in hhmmss format For example you may see the following alternating displays POSITION 3 POSITION 3 Varian Inc Revision F 01 06 VK 100 Aut
27. ner These can scratch the material s surface and or weaken it causing small surface cracks called crazing Varian Inc Revision F 01 06 VK 100 Automated Disintegration Apparatus Page 39 P N 70 9011 Operator s Manual Maintenance and Troubleshooting 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 e Isopropyl alcohol maximum 25 Repairing Leaking Fittings Complete these steps if any of your water bath fittings are leaking Step 1 Turn off the heater circulator and drain the water bath completely Step 2 Remove the leaky bulkhead fitting Step 3 Remove the elbow fitting from the bulkhead fitting Step 4 Inspect the bulkhead fitting gaskets for damage and replace them as necessary Step 5 Remove the old Teflon tape from all male fittings Inspect the threads for damage and replace the fitting as necessary Step 6 Apply new Teflon tape to the male fitting threads Step 7 Reinstall and tighten the bulkhead fitting on the water bath Step 8 Reinstall and tighten the elbow fitting to the bulkhead fitting Step 9 Fill the water bath and turn on the heater circulator Step 10 Inspect the fitting for leaks If the fitting still leaks contact the Dissolution Systems Service Department Varian Inc Page 40 VK 100 Automated Disintegration Apparatus Revision F 01 06 Maintenance and Troub
28. ns and Limitations 54 Obtaining Warranty Service 54 Warranty Limitations 54 Exclusive Remedies 55 Index 57 Tell Us How We Are Doing 59 Varian Inc Table of Contents This page was intentionally left blank except for this message Varian Inc List of Figures FIGURE 1 VK 100 Single basket Model 16 FIGURE 2 Water Bath Connections 20 FIGURE 3 VK 100 Rear Panel 22 FIGURE 4 VK 100 Keypad 24 FIGURE 5 Basket Adjustment 28 Varian Inc List of Figures This page was intentionally left blank except for this message Varian Inc chapter1 Safety Practices and Hazards The VK 100 has been carefully designed so that when used properly you have an accurate fast flexible and safe instrument If the equipment is used in a manner not specified by the manufacturer the protection provided by the equipment may be impaired Operation of a VK 100 involves the use of aqueous liquids 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 100 Automated Disintegration Apparatus Revisi
29. omated Disintegration Apparatus Page 31 P N 70 9011 Operator s Manual Operation Step 2 The example on page 30 indicates the previously programmed test length for position 1 was 30 minutes 1 To accept the current test length press ENTER 2 To change it enter the new value in hhmmss format and press ENTER 3 To disable position 1 enter 000000 for the test length and press ENTER In the display the numeral 2 flashes alternating with the previously programmed delay time for position 2 in hhmmss format The delay time is the amount of time between the start of the program and the start of dipping for position 2 For example you may see the following alternating displays POSITION 3 POSITION 3 The above example indicates the previously programmed delay time for position 2 was 5 minutes 1 To accept the current delay time press ENTER 2 To change it enter the new value in hhmmss and press ENTER 3 If no delay is desired enter 000000 and press ENTER Note ON There is no delay time for position 1 Step 3 In the display the numeral 2 flashes again this time alternating with the previously programmed test length for position 2 For example you may see the following alternating displays POSITION 3 POSITION 3 Varian Inc Page 32 Operation VK 100 Automated Disintegration Apparatus Revision F 01 06 Operator s Manual P N 70 9011 Step 4 Step 5 The examp
30. on F 01 06 Safety Practices and Hazards Operator s Manual P N 70 9011 Electrical Hazards The VK 100 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 VK 100 to determine which parts are operator accessible Application of the wrong supply voltage connection of the instrument to an incorrectly wired supply outlet or lack of proper electrical grounding can create a fire hazard or a potentially serious shock hazard and could seriously damage the instrument and any attached ancillary equipment Always use a three wire outlet with ground connection which is adequately rated for the load The installation must comply with local state and federal safety regulations Do not connect the instrument to the main power supply until you have made sure that the operating voltage is correctly set for the main power supply in the specific outlet in your laboratory to which the equipment will be connected Other Other specific warnings and cautions appear in the manuals where appropriate and detail the specific hazard describe how to avoid it and specify the
31. 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 56 VK 100 Automated Disintegration Apparatus Revision F 01 06 Service and Warranty Operator s Manual P N 70 9011 This page was intentionally left blank except for this message Varian Inc Index numerics 3 basket operation 33 a acrylic care 38 b basket height adjusting 28 c cartridge ribbon 43 caution 11 conventions 17 d disintegration basket care 37 draining the water bath 26 e electrical connections 21 electrical hazards 10 exclusions 54 exclusive remedies 55 ext temp probe led 24 f filling beakers 25 fuse replacement 49 h hazards 9 heater on led 24 hidden key functions 26 i information symbols 12 initial power up 21 installing the printer cartridge ribbon 43 introduction 15 Varian Inc Index l u leaking fittings repairing 39 unpacking your vk 100 19 limitations 54 w m warranty 53 monthly maintenance 36 warranty limitations 54 mounting baskets 25 water bath care 38 multi basket operation 30 water bath status leds 24 water bath temperature setting 27 o weekly maintenance 36 obtaining warranty service 54 operating mode selecting 29 over temp led 24 p periodic maintenance 35 placing dosage units 29 print freq 28 print frequency for printer setting 28 printer confi
32. 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 F 01 06 VK 100 Automated Disintegration Apparatus Page 11 P N 70 9011 Operator s Manual Safety Practices and Hazards These symbols may be used on warning labels attached to the instrument When you see one of these symbols you must refer to the relevant operation or service manual for the correct procedure referred to by that warning label The meaning of the symbols that appear alongside warnings in this manual are as follows Electrical shock Caution Refer to accompanying documents Read all warnings and cautions carefully and observe them at all times Caution A Caution message is used 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 100 Automated Disintegration Apparatus Revision F 01 06 Safety Practices and Hazards Operator s Manual P N 70 9011 Information Symbols Switches main power on Switches main power off Indicates single phase alternating current Indicates the product complies with the requirements of on
33. r 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 Varian Inc Page 44 VK 100 Automated Disintegration Apparatus Revision F 01 06 Maintenance and Troubleshooting Operator s Manual P N 70 9011 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 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 Step 2 Grasp the paper roll cover firmly by the grooves on the side and the front edge Pull outward to remove the cover Step 3 Press the printer toggle switch to Paper feed to advance the paper approximately one inch beyond the paper cutter Step 4 Using scissors cut the paper feeding to the printer and remove the paper roll Step 5 Pull the remaining paper through the printer mechanism Pull the paper from the front paper cutter side Pulling the paper out of the back of the printer will damage the print mechanism Step 6 Unroll several inches of paper on the new roll Step 7 If it
34. ranty 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 55 Revision F 01 06 VK 100 Automated Disintegration Apparatus Service and Warranty P N 70 9011 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 be liable for any direct indirect special incidental or consequential damages whether based on contract tort or any other legal theory Some states
35. rian 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 54 VK 100 Automated Disintegration Apparatus Revision F 01 06 Service and Warranty Operator s Manual P N 70 9011 Exclusions and Limitations Excluded from this warranty are expendable or consumable items such as but not limited to paddles baskets vessels and acrylic water baths Also excluded are defects from improper or inadequate maintenance by the customer user induced chemical action or contamination unauthorized modification or misuse and improper site preparation and maintenance Operation of software is not warranted to be uninterrupted or error free Obtaining Warranty Service To obtain war
36. rical Hazards 10 Other 10 General 12 WEEE Directive 13 Chapter 2 Introduction 15 Conventions Used in this Manual 17 Chapter 3 Setup 19 Unpacking Your VK 100 19 Setting up the Water Bath 20 Initial Power Up 21 Electrical Connections 21 Varian Inc Table of Contents Chapter 4 Chapter 5 Installing the Temperature Probe 23 Water Bath Status LEDs 24 Setting the Date Time Clock 25 Mounting Baskets and Filling Beakers 25 Draining the Water Bath 26 Hidden Key Functions 26 Operation 27 Setting Water Bath Temperature 27 Setting Print Frequency for the Report Center Printer 28 Adjusting Basket Height 28 Placing Dosage Units inthe Baskets 29 Selecting Operating Mode 29 Single basket Operation 29 Multi basket Operation 30 Three Basket Operation 33 Printer Operation During Manual or Program Operation Optional 34 Maintenance and Troubleshooting 35 Periodic Maintenance 35 Weekly Maintenance 36 Monthly Maintenance 36 Every Six Months Maintenance 36 Yearly Maintenance 37 Disintegration Basket Care 37 Water Bath Acrylic Care 38 Visual Checks 40 Water Bath Temperature Probe Accuracy Test 41 Varian Inc Table of Contents Chapter 6 Report Center Impact Printer 43 Installing the Cartridge Ribbon 43 Replacing the Paper Roll 44 Toggling Your Printer Online 45 Printer Self Test 46 Printer Configuration 47 Main Power Fuse Replacement 49 Troubleshooting 50 Service and Warranty 53 Exclusio
37. rom the water bath to the pump Remove the tubing from the pump and inspect the inlet of the pump for debris The pump is faulty Contact the Dissolution Systems Service Department for assistance Varian Inc Revision F 01 06 P N 70 9011 Operator s Manual VK 100 Automated Disintegration Apparatus Page 51 Maintenance and Troubleshooting Symptom Probable Cause Possible Solution The OverTemp light remains on The water bath level is too low Add water to the water bath Air is trapped in the tank or lines Attempt to prime the system by raising and lowering the front and rear of the instrument The temperature probe may be in the wrong position or faulty Inspect the position and condition of the water bath temperature probe Ensure the probe is plugged into the VK 100 Check the position of the probe within the water bath and ensure it is fully submerged The temperature probe should only be used to measure the water bath temperature Faulty readings occur if you use the probe in any other manner Operation is noisy Air is trapped in the tank or lines Attempt to prime the system by raising and lowering the front and rear of the instrument The pump or motor is faulty Inspect the electrical connection from the pump motor to the main PCB for damage or excessive wear Replace the pump if necessary Contact the Dissolution Systems S
38. rt Center Printer you can generate a printout of the instrument status at any time by pressing PRINT This does not affect automatic printing as set by the PRINT FREQ function Varian Inc chapters Maintenance and Troubleshooting Periodic Maintenance Warning The 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 intervals may vary depending on frequency of instrument usage Varian Inc Page 36 VK 100 Automated Disintegration Apparatus Revision F 01 06 Maintenance and Troubleshooting Operator s Manual P N 70 9011 Weekly Maintenance See Disintegration Basket Care on page 37 and Water Bath Acrylic Care on page 38 as applicable for additional information on proper maintenance of your equipment e Ensure media is removed and the system is wiped with a clean damp cloth Inspect the water bath and circulator tubing for algae other material and cracks damage If algae is present change the bath water and add algaecide e If any stainless steel parts show signs of surface discoloration lightly wipe the surface with a soft cloth or nonabrasive pad to remove it Monthly Maintenance See Water Bath Acrylic Care on page 38 as applicable for additional information on proper maintenance of your equipment
39. sistance value of the probe at the 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 Page 42 VK 100 Automated Disintegration Apparatus Revision F 01 06 Maintenance and Troubleshooting Operator s Manual P N 70 9011 Temp Resistance Temp Resistance Temp Resistance Centigrade Ohms Centigrade Ohms Centigrade 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 67 0 437 40 10 0 4482 68 0 422 50 11 0 4273 69 0 408 20 12 0 4074 70 0 394 50 13 0 3886 71 0 381 20 14 0 3708 72 0 368 50 15 0 3539 73 0 356 20 16 0 3378 74 0 344 50 17 0 3226 75 0 333 10 18 0 3081 76 0 322 30 19 0 2944 48 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
40. tion Step 6 Press RUN PROG The programmed sequence displays in the position 3 screen If correct press ENTER The program begins To stop any individual basket during multi basket operation press STOP where is the basket number you want to stop To stop all baskets at the same time press STOP in the lower right corner of the keypad Note When an individual basket is stopped and the other baskets are I gt dipping the individual basket can only be restarted in the independent single basket mode It cannot be restarted as part of the running program Three Basket Operation To run all three baskets together starting and stopping at the same times complete the following steps Step 1 Press RUN MANUAL The previously set test length if any for three basket operation flashes in the position 3 screen Step 2 Press ENTER to accept the displayed values or enter a new test length in hhmmss format and press ENTER All three baskets lower and begin dipping The baskets stop simultaneously lifting automatically at the end of the programmed time period Note Press STOP to stop all three baskets at any time during the test IE gt Varian Inc Revision F 01 06 Page 34 VK 100 Automated Disintegration Apparatus P N 70 9011 Operation Operator s Manual Printer Operation During Manual or Program Operation Optional If your VK 100 is equipped with the optional Repo
41. tion 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 47 for Varian Inc Page 46 VK 100 Automated Disintegration Apparatus Revision F 01 06 Maintenance and Troubleshooting Operator s Manual P N 70 9011 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 VK 100 Step 2 Press and hold the printer toggle switch in the Paper feed position Step 3 Turn on the VK 100 Step 4 Hold the printer toggle switch until printing begins The printer prints a list of the current configuration settings and performs a continuous print test Step 5 Press the printer toggle switch to the OnLine Off Line position to stop the printing operation Step 6 The printer is ready to resume normal operation Varian Inc Revision F 01 06 VK 100 Automated Disintegration Apparatus Page 47 P N 70
42. ual Operation Placing Dosage Units in the Baskets Place one dosage unit in each of the six tubes of the basket USP fluted disks may be added where specified in the individual monograph Selecting Operating Mode You can select single basket multi basket or three basket operation Note T gt The position 3 screen is the display screen for all programming regardless of which position or parameter you are programming Single basket Operation In single basket mode the operation of each basket is set independent of the others To start a single basket Step 1 Press RUN where is the basket number you want to run The current test time for that position if any flashes For example the following display indicates that the basket in the selected position is currently programmed to dip for 10 minutes POSITION 3 001000 Step 2 To accept the current test length press ENTER The basket lowers and begins dipping lifting automatically at the end of the programmed time period To enter a different dip time value enter the new value in hhmmss format and press ENTER to start the dip cycle Varian Inc Page 30 VK 100 Automated Disintegration Apparatus Revision F 01 06 Operation Operator s Manual P N 70 9011 Step 3 To stop the dip cycle of a basket before the end of the programmed time press STOP where is the basket number you want to stop The basket stops dipping and lifts from the beaker i
43. uses This will prevent them from coming into contact with each other or anything else in the storage area Water Bath Acrylic Care Caution Do not use cleaning compounds containing ammonia or abrasive cleaners on your water bath The water bath supplied with the VK 100 Disintegration Apparatus should be maintenance free except for an occasional cleaning If you use a water bath algaecide or clear bath product ensure it is compatible with PETG and acrylic The flow paths in the heater circulator are primarily stainless steel and should tolerate most clear bath formulations Check with the product manufacturer to be sure the product is safe for your water bath 1 All of our water baths are fabricated entirely of commercial grade acrylic When using them with corrosive materials such as hydrochloric acid or media containing salts be sure to rinse them thoroughly with deionized water immediately after each use and dry thoroughly with a soft towel or cloth 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 Do not use ammonia window cleaning sprays kitchen scouring compounds or solvents such as acetone gasoline benzene alcohol carbon tetrachloride or lacquer thin
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