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Maxwell

16 Clinical Instrument

Operating Manual

INSTRUCTIONS FOR

USE OF PRODUCT

A S 2 0 5 0

MDSS GmbH

Schiffgraben 41

30175 Hannover, Germany

In Vitro Diagnostic

Medical Device

PRINTED IN USA. 2/0

Part# TM300

tm300.0208_Corrected.qxp 3/11/2008 10:36 AM Page a

Summary of Contents for Maxwell 16

Page 1: ...t Operating Manual INSTRUCTIONS FOR USE OF PRODUCT A S 2 0 5 0 MDSS GmbH Schiffgraben 41 30175 Hannover Germany In Vitro Diagnostic Medical Device PRINTED IN USA 2 08 Part TM300 tm300 0208_Corrected q...

Page 2: ...nd Operational Mode Setup Requirements 14 iii Setting the Maxwell 16 Instrument Operational Mode 15 iv Changing the Maxwell 16 Instrument Display Language 15 IV Operating the Maxwell 16 Instrument 16...

Page 3: ...lications of the Maxwell 16 System 27 A Operational Mode Setup Requirements 27 B Reconfiguring the Maxwell 16 Instrument Hardware 30 C Instrument Accessories and Purification Kits for Research and For...

Page 4: ...ge Directive Electromagnetic Compatibility Directive and the In Vitro Diagnostic Medical Device Directive and associated harmonized standards The Maxwell 16 System is intended for professional use onl...

Page 5: ...of the bound particles away from other cellular components Elution of nucleic acids into a formulation that can be added directly to standard PCR The user selects the clinical protocol as prompted by...

Page 6: ...n that standardizes nucleic acid sample preparation workflow in the clinical laboratory Comprehensive technical support The system is controlled via a multi language LCD readout and the default operat...

Page 7: ...Maxwell 16 Cartridge Rack 1 Maxwell 16 Magnetic Elution Rack Promega Corporation 2800 Woods Hollow Road Madison WI 53711 5399 USA Toll Free in USA 800 356 9526 Phone 608 274 4330 Fax 608 277 2516 www...

Page 8: ...well 16 Instrument please inspect the package carefully to make sure all accessories are present Standard accessories are shown in Figure 1 Figure 1 Maxwell 16 Instrument AS2050 accessories A Operatin...

Page 9: ...c environment of the instrument prior to operation Promega Corporation 2800 Woods Hollow Road Madison WI 53711 5399 USA Toll Free in USA 800 356 9526 Phone 608 274 4330 Fax 608 277 2516 www promega co...

Page 10: ...that the plungers have been completely removed from the magnet rods before pressing Run Stop to extend the platform Use only Promega Maxwell 16 cartridges and plungers designed for use with the instr...

Page 11: ...all in a location where there is large temperature variability or high humidity Do not position the instrument so that it is difficult to unplug from the power source Do not place next to heat sources...

Page 12: ...display panel The LCD display panel and keypad including Run Stop Menu Scroll Up and Scroll Down buttons are shown Figure 3 Maxwell 16 components Standard SEV configuration magnetic rod assembly and...

Page 13: ...red in place during shipment to prevent movement of and damage to these parts Note Do not plug in or turn on the machine before removing the shipping anchors Turning on the Maxwell 16 Instrument befor...

Page 14: ...nection on the back of the instrument 3 Connect the power cord to the back of the Maxwell 16 Instrument 4 Plug the power cord into a wall outlet See Section I G for power requirements 5 Close the door...

Page 15: ...xwell 16 Blood DNA Purification Kit The Maxwell 16 Instrument Cat AS2050 is supplied configured for use in clinical mode with SEV hardware Table 1 Hardware Configuration and Operational Mode Setup Req...

Page 16: ...he screen will display both the firmware version number and the current operational mode setting The Maxwell 16 Instrument Cat AS2050 is supplied configured for use in clinical mode with SEV hardware...

Page 17: ...f this test the screen will display either Diagnostic Check Successful or Calibration Error During instrument runs During runs the instrument will automatically do periodic self diagnostic tests to ve...

Page 18: ...otective gloves when handling the reagent cartridges Users should follow their institutional guidelines for disposal IV D Minimizing Cross Contamination Users should follow standard laboratory procedu...

Page 19: ...with deionized water or 70 ethanol Keep the cooling vents in the back of the machine clear of dust Do not remove the Maxwell 16 Instrument case for cleaning This will void the warranty Do not use a s...

Page 20: ...tic rod assembly wipe with a soft paper towel dampened with deionized water or 70 ethanol Removal of paramagnetic particles from the magnetic rod assembly will require multiple wipes with a damp cloth...

Page 21: ...an hear the motors running Either a cable has become disconnected from the LCD screen or the LCD screen is broken or damaged Contact Promega or your local Promega representative for service The machin...

Page 22: ...mega or your local Promega representative for service Poor sample quality low yield or low purity See the troubleshooting section of the Technical Manual supplied with your Maxwell 16 Purification Kit...

Page 23: ...screen see Section IV B Verify that the shipping anchors have been removed Refer to Section III B Turn the instrument off wait a few seconds then turn the instrument back on If the calibration error p...

Page 24: ...connect the RS 232 Cable from the computer The RS 232 Cable may be left plugged into the instrument if desired Please contact Promega or your local Promega representative for assistance if you encount...

Page 25: ...t into the small inside shipping box Ensure that the top of the instrument is facing the top of the open box 4 Slide the small inside shipping box containing the instrument into the large outside ship...

Page 26: ...ument surfaces Repeat the procedure as many times as required to effectively disinfect and decontaminate the instrument Failure to confirm disinfection and decontamination will result in decontaminati...

Page 27: ...Write or call the company that sold you the instrument and describe as precisely as possible the nature of the problem 2 Carry out minor adjustments or tests as suggested by your technical contact 3 I...

Page 28: ...on and operational mode requirements for the Maxwell 16 Purification Kits Please refer to the Technical Manual supplied with your specific purification kit for further information on the operational m...

Page 29: ...ing see ii below Changing the Maxwell 16 Instrument Operational Mode 6033ME Fnsc Promega MAXWELL 16 Purification System Version 4 0 LEV Operational Mode Setting Rsch Research Fnsc Forensic IVD Clinica...

Page 30: ...un Stop Key If changing from SEV to LEV the following screens will appear 6220MB Hardware Setup Remove SEV hardware Magnet Assembly Press Run Stop Key Hardware Setup Add LEV hardware Magnet Plunger Ba...

Page 31: ...16 Cat AS1250 is required i Changing from Standard to LEV Configuration Note Do not reconfigure the instrument while samples or reagent cartridges are in place on the instrument platform To avoid pot...

Page 32: ...should then be fairly difficult to remove 6 Insert the black LEV Magnetic Rod Assembly The screws should be facing toward you Press firmly to place the LEV Magnetic Rod Assembly in position It will f...

Page 33: ...the instrument s electronics 3 Unscrew the three thumbscrews on top of the magnetic rod assembly 4 Gently lift up the LEV Magnetic Rod Assembly to remove it 5 Pull down on the LEV Plunger Bar Adaptor...

Page 34: ...e Sufficient for 48 automated isolations from tissue cells or blood sample types Product Size Cat Maxwell 16 Tissue LEV Total RNA Purification Kit 48 preps AS1220 For Laboratory Use Sufficient for 48...

Page 35: ...axwell 16 LEV Cartridge Rack 1 Quick Start Guide Product Cat Maxwell 16 LEV Cartridge Rack for use with LEV configuration AS1251 Maxwell 16 Cartridge Rack for use with standard configuration AS1201 Ma...

Page 36: ...at No 730718 Singapore Pat No 64532 and Korean Pat No 486402 have been issued to Promega Corporation for an improved filtration system and method Other patents are pending 2008 Promega Corporation All...

Page 37: ...800 Woods Hollow Road Madison WI 53711 5399 USA Toll Free in USA 800 356 9526 Phone 608 274 4330 Fax 608 277 2516 www promega com Part TM300 Printed in USA Page 36 2 08 tm300 0208_Corrected qxp 3 11 2...

Page 38: ...0 Promega Corporation Madison WI USA 53711 Promega Corporation 2800 Woods Hollow Road Madison WI 53711 5399 USA Telephone 608 274 4330 Fax 608 277 2601 w w w p r o m e g a c o m tm300 0208_Corrected q...

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