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Promega Corporation · 2800 Woods Hollow Road · Madison, WI 53711-5399 USA · Toll Free in USA 800-356-9526 · 608-274-4330 · Fax 608-277-2516

69

www.promega.com

TM411 · Revised 4/15

Maxwell

®

RSC Installation Qualification and Operational Qualification

Cat.# SA1347, SA1348, SA1349

The Installation Qualification service product includes a series of formal instrument checks, delivers written
documentation of instrument functionality, and demonstrates that everything ordered with the instrument
is supplied and installed at the customer’s laboratory. This service product must be delivered by a Promega
representative who is certified to perform the Installation Qualification. The service product involves a site
visit to perform:

•  Installation by qualified Promega personnel
•  Inspection of shipping containers, instrument, and accessories
•  Comparison of items received vs. items on purchase order
•  Inspection of laboratory conditions
•  Review of all hazards and precautions with users
•  Confirmation/installation of correct firmware version
•  Testing of instrument run
•  Recording and documenting installation and actions

The Operational Qualification service product demonstrates that the instrument functions according to its
operational specifications. This service product must be delivered by a Promega representative who is
certified to perform the Operational Qualification. The service product involves a site visit to perform:

•  Run operational verification tests
•  Documenting all calibration and test results
•  Train customer(s) to operate the instrument
•  Train customer(s) to use the log book
•  Complete customer-specific log book, instrument sticker and OQ documentation

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Summary of Contents for Maxwell RSC Instrument

Page 1: ...Revised 4 15 TM411 Maxwell RSC Instrument Operating Manual Instructions for use of the Maxwell RSC Instrument Catalog Number AS4500 O P E R A T I N G M A N U A L Revised 4 15 TM411...

Page 2: ...2 4 Setting up the Maxwell RSC Instrument 13 4 A Setting Up the Maxwell RSC Instrument 13 4 B Setting Up the Tablet PC 14 4 C Switching On the Maxwell RSC Instrument 16 4 D Shutting Down the Maxwell R...

Page 3: ...with Spills 61 7 Troubleshooting 62 7 A Errors and Warnings 63 7 B Use of a USB Flash Drive 64 8 Appendix 64 8 A Service 64 8 B Returning the Maxwell RSC Instrument for Service 64 8 C Repacking the M...

Page 4: ...port sample tracking and method run data An optional Bar Code Reader available separately Cat AS4010 can be used with the Maxwell RSC Instrument to start method runs and capture bar code information f...

Page 5: ...e Promega Quantus Fluorometer Comprehensive technical support System controlled via tablet PC Reporting functionality Preprogrammed purification methods UV lamp to aid in decontamination of instrument...

Page 6: ...blet PC 1 Maxwell RSC CSC Deck Tray 1 UV Bulb installed 1 Quantus Fluorometer and accessories 1 Tablet PC Holder 1 Quick Start Guide 1 Setup Guide 1 G Inspection Upon receiving your Maxwell RSC Instru...

Page 7: ...may result in damage to the instrument Use only Promega Maxwell RSC branded and supplied cartridges plungers and elution tubes Do not reuse cartridges plungers or elution tubes If the equipment is use...

Page 8: ...lectrical shock 5295MA eps Warning Risk of personal injury to the operator or a safety hazard to the instrument or surrounding area Warning Pinch point hazard Warning Hot surface Burn hazard 6422MA Wa...

Page 9: ...Sunnyvale CA 94085 USA 249469 Consult your local Promega Representative regarding instrument disposal WEEE Directive European Community directive 2002 96 EC on Waste Electrical and Electronic Equipme...

Page 10: ...ocation that meets the following criteria Locate on a sturdy level surface Avoid dusty areas Choose a location that has good air circulation and is not exposed to direct sunlight Avoid electrically no...

Page 11: ...showing the On Off switch power cable connector and USB communication port for the Tablet PC and the 3 port USB hub for accessories such as the Quantus Fluorometer Figure 4 Magnetic assembly componen...

Page 12: ...ping box 2 Open the flaps and remove the accessories box from the packaging Figure 5 Figure 5 The accessories box 3 Remove the upper packing material and carefully remove the instrument from the box F...

Page 13: ...RSC Instrument 4 A Setting Up the Maxwell RSC Instrument 1 Manually open the door of the Maxwell RSC Instrument and carefully remove the two foam pieces from inside the instrument Figure 7 Removing t...

Page 14: ...g Up the Tablet PC 1 Remove the Tablet PC from the box 2 Locate the Tablet PC Holder and place it on top or adjacent to the Maxwell RSC Instrument Figure 8 Tablet PC Holder 3 Raise the middle leg of t...

Page 15: ...let We recommend connecting the Tablet PC to an uninterruptible power supply Figure 10 Tablet PC installed on the Maxwell RSC Instrument 5 Connect the USB Cable to the Tablet PC and plug the other end...

Page 16: ...now ready to use 4 C Switching On the Maxwell RSC Instrument Once all the foam pieces have been removed and the Tablet PC set up you can connect the instrument to a power outlet The power switch is lo...

Page 17: ...ch the instrument OFF using the On Off switch Unplug the instrument If you need to store the instrument switch the instrument OFF unplug the instrument and store in a place that meets the environmenta...

Page 18: ...dows operating system Windows 8 conventions are used throughout the Maxwell RSC software and can be used to navigate to the various screens Touching and holding on the tablet screen for 3 seconds is e...

Page 19: ...User Accounts to Promega Groups The Maxwell RSC User Interface employs the Windows login user access levels as a security tool for adding approved users and associated passwords New user accounts sho...

Page 20: ...w will open which can be used to add existing users to the PromegaAdministrators group Tap the Add button to add users to the PromegaAdministrators group In the Enter the object names to select area o...

Page 21: ...rs to the PromegaUsers group Removing User Accounts The Maxwell RSC User Interface employs the Windows login user access levels as a security tool for adding approved users and associated passwords Re...

Page 22: ...ch the Remove button Touch OK to remove users from the PromegaUsers group Set Instrument Name Within the Maxwell RSC Software administrators can set the instrument name by touching the Instrument Name...

Page 23: ...reports settings and even start the procedure of setting up a new protocol processing run as long as these functions do not proceed to an interruption of the sanitization procedure Functions that are...

Page 24: ...porting purposes It is also possible to configure the Maxwell RSC software for entry of cartridge ID elution tube ID and two additional administrator defined sample identification fields these values...

Page 25: ...hese options is enabled the administrator has the option to choose whether the sample identifiers scanned for the indicated fields are required to match the Sample ID This is useful for ensuring that...

Page 26: ...ega com 4 F Maxwell RSC User Interface Screens continued Figure 22 Maxwell RSC Settings screen From this screen you can access Administrator settings for the Maxwell RSC Instrument options Figure 23 M...

Page 27: ...4 Maxwell RSC Sample Entry window This window gives the administrator the ability to configure the software for the bar code entry requirements necessary prior to performing a sample processing protoc...

Page 28: ...the Administrator can specify the Sanitization settings in minutes and other settings such as Sanitize after extraction and or Sanitize on instrument startup for a specified amount of time Figure 26...

Page 29: ...Select Import Package button to import new protocol methods Figure 28 If an updated method is imported for an existing kit the new method will replace the original one The current path that has been s...

Page 30: ...ed kits Checking this box allows users to run methods with kits that have passed their expiration date When this box is unchecked the software will not allow expired kits to be used for any purificati...

Page 31: ...d for an existing kit the method will replace the original one If you want to reinstall the previous method you will need to use the package file that contains the previous method If administrators im...

Page 32: ...tine test Figure 31 to confirm that instrument functions including initialization of the deck tray plunger bar and magnet bar motion of these systems and the instrument heater are operating within acc...

Page 33: ...each position on the deck tray that did not unload a plunger properly during the run On touching the Clean Up button you will be presented with a clean up information list Figure 34 including the fol...

Page 34: ...15 www promega com 4 F Maxwell RSC User Interface Screens continued Figure 33 Clean Up informational list screen This screen presents you with a list of actions that must be performed prior to clean...

Page 35: ...ually enter the bar code information or use an optional bar code reader to scan the bar code on a Maxwell RSC Purification Kit box This will select and highlight the appropriate installed method for t...

Page 36: ...alog Number Kit Lot Number Expiration Date in year month format example AS13303221872015 05 where the product catalog number is AS1330 the kit lot number is 322187 and the expiration date is 2015 05 O...

Page 37: ...ions Section 4 F If the administrator has allowed the use of expired kits a user prompt will appear indicating that the kit has passed the expiration date but you will allowed to continue b If the sca...

Page 38: ...d The unused positions will turn gray with no data shown The inclusion or exclusion of any given sample processing position is only used for reporting purposes to indicate how many samples were proces...

Page 39: ...it lot number is 322187 and the expiration date is 2015 05 Note that positions with incomplete information will display a red circle with an exclamation point at the top of the blue rectangle The Proc...

Page 40: ...he entry area will move to the next available cartridge position Select multiple positions by swiping across the positions to be selected to enter kit lot information for multiple cartridge positions...

Page 41: ...n extraction process Touch the Start button to begin the run after all checklist items have been performed or touch the Cancel button to return to the Cartridge Setup screen Figure 41 Extraction Check...

Page 42: ...igure 42 Placing the cartridges in the Deck Tray and pressing firmly to snap them in place Completely remove seals from all cartridges Place elution tubes at the selected positions in the deck tray Ad...

Page 43: ...e magnetic rod assembly must be thoroughly cleaned see Section 6 B and the samples will be lost 8 While the protocol runs you will see the Protocol Selected screen Figure 44 The title bar of the Proto...

Page 44: ...instrument error Figure 44 Protocol Selected screen The Protocol Selected screen is displayed during a protocol run This screen indicates what protocol is currently being run at the top of the screen...

Page 45: ...shed After a protocol is completed you can touch the Open Door button to open the door of the Maxwell RSC Instrument to remove the deck tray Close the caps of the elution tubes and remove the tubes fr...

Page 46: ...sing the elution tube caps Figure 47 Removing the elution tubes and the deck tray After the door is opened the Report View screen Figure 56 will be presented If the administrator has required that UV...

Page 47: ...lean Up Window Figure 50 An aborted run initiated by the user or due to instrument error will result in the loss of all the samples Do not attempt to repurify samples from an aborted run Figure 48 Pro...

Page 48: ...ill list the reason for aborting the protocol An aborted run initiated by the user or due to instrument error will result in the loss of all the samples Do not attempt to repurify samples from an abor...

Page 49: ...If a protocol is aborted by the user or due to an instrument error the Clean Up window is displayed that asks the users to Start Clean Up or Skip Clean Up depending on whether the plungers are still e...

Page 50: ...ults that can be added to the run report the Quantus Fluorometer must be calibrated and used with an appropriate fluorescent dye If the Quantus Fluorometer is correctly connected and ready to run the...

Page 51: ...antitate button in lower left corner to associate quantitation values read by the Quantus Fluorometer with samples from this run 2 Select Quantitate on the lower left side of the screen 3 The Measure...

Page 52: ...omplete a result will be displayed to the right of the sample identifier on the Maxwell RSC screen Figure 54 Quantus Measurement Screen After making a quantitation measurement with the Quantus Fluorom...

Page 53: ...button in the center bottom of the Maxwell RSC screen 13 A dialog box for the Quantitation parameters will pop up Enter the kit name of the kit used to quantitate the sample and a description of the...

Page 54: ...n this report are the sample tracking information recorded prior to starting the protocol the final status of the protocol Completed or Aborted the time the protocol run was started the length of time...

Page 55: ...collected and saved by touching on the Quantitation tab on the bottom of the Run report Figure 57 Quantitation Report screen The Quantitation Report screen shows data gathered using the Quantus Fluor...

Page 56: ...ould be saved Touch the Export button to navigate to where the report should be exported and then touch the Save button The Maxwell RSC Instrument exports reports in both the xls format and txt tab se...

Page 57: ...ons on the left side of the reports Touch the column headers to sort the report based on column contents Touch the desired row to see a detailed view of the report data from that protocol run Figure 6...

Page 58: ...een Figure 63 by touching the Sanitize button Make sure all samples have been removed from the instrument prior to initiating the UV sanitization protocol You will be presented with a sanitization che...

Page 59: ...re present in the instrument prior to running Sanitization After Sanitization is completed you will see a flashing indicator Touch the indicator to view the Sanitization report Note UV radiation is us...

Page 60: ...ent is used with biohazardous materials dispose of any cleaning materials used in accordance with your institutional guidelines Clean the Maxwell RSC Instrument after every use Keep the vents in the b...

Page 61: ...ng to your institutional guidelines Wipe well once visible material is removed In case of spills in the instrument where there is a potential biohazard wipe up the spill with paper towels and wash the...

Page 62: ...y that the power supply is securely connected to the Tablet PC Verify that the instrument is plugged in to the USB port on the Tablet PC Restart the Maxwell RSC Tablet PC and launch Maxwell RSC softwa...

Page 63: ...ully seated in the tray Reseat the cartridges in the tray If error still persists contact Promega Technical Services Door sensor tripped Door sensor trip detected Contact Promega Technical Services Do...

Page 64: ...rmance with little mainte nance If a problem arises with your instrument please contact Promega or your local Promega representa tive for support Visit the Promega Web site at www promega com for the...

Page 65: ...well RSC Instrument packaging Ship the Maxwell RSC Instrument only with Promega packaging to avoid any damages 1 Turn the instrument OFF and unplug it from the outlet 2 Open the instrument door and ma...

Page 66: ...xwell RSC Instrument continued 7 Place the instrument in the bottom foam packaging material The instrument will only fit properly into the bottom foam piece in one orientation Figure 67 Figure 67 Maxw...

Page 67: ...strument in correct orientation in the box 10 Close the flaps on the shipping container top and secure them with packing tape 11 Write the return authorization number provided to you by Promega or you...

Page 68: ...ement covers all parts labor and shipping to and from our depot repair location as well as a loaner instrument upon request If your Maxwell RSC needs repair we will provide a box for shipment of the i...

Page 69: ...tion by qualified Promega personnel Inspection of shipping containers instrument and accessories Comparison of items received vs items on purchase order Inspection of laboratory conditions Review of a...

Page 70: ...ement Promega agrees as its sole responsibility under this Warranty and upon prompt notice of a defect to repair or replace at Promega s discretion any instrument discovered to be defective within the...

Page 71: ...son WI 53711 5399 USA Toll Free in USA 800 356 9526 608 274 4330 Fax 608 277 2516 71 www promega com TM411 Revised 4 15 9 C Related Products Product Size Cat Maxwell Instrument Bar Code Reader 1 each...

Page 72: ...fectively disinfect and decontaminate the instrument Failure to follow these decontamination guidelines sign and return the Decontamination Form will result in decontamination charges before the instr...

Page 73: ...romagnetic environment for the equipment can be maintained in order that the device will perform as intended 2014 2015 Promega Corporation All Rights Reserved Maxwell is a registered trademark of Prom...

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