background image

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.com

Printed in USA.

Part# TM300

2/08

Page 27

VIII. Appendix II: Research and Forensic Applications of the Maxwell

®

16 System

This section of the Technical Manual discusses use of the Maxwell

®

16 System for Research and Forensic

applications. Operation of the instrument in Research and Forensic modes, or with kits other than 

Cat.# AS1015, has not been demonstrated to comply with EU Directive 98/79/EC on in vitro diagnostic

medical devices. 
The Maxwell

®

16 Clinical Instrument (Cat.# AS2050) i

s supplied configured for use in clinical mode with SEV

(Standard Elution Volume) 

hardware

. When used for research or forensic applications, the instrument may

be configured with SEV or LEV (Low Elution Volume) hardware for different elution volume preferences.

See Section VIII.B for instructions on how to configure your instrument in SEV or LEV format. 

VIII.A. Operational Mode Setup Requirements

The Maxwell

®

16 Instrument has multiple operational modes, depending on the procedure and the

purification kit used. Table 2 lists the hardware configuration 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 mode required.

Table 2. Hardware Configuration and Operational Mode Setup Requirements for Research and

Forensic Applications.

Please ensure that you select the operational mode that is required for your hardware configuration. Failure to

use the correct operational mode and hardware configuration will cause damage to the instrument

.

Maxwell

®

16 Kit

Purification 

Procedure

Firmware

Operational Mode

Hardware

Configuration

Maxwell

®

16 gDNA

Purification Kits 

(Cat.# AS1010, AS1020, AS1030)

gDNA

Research 

(Rsch)

Standard Elution

Volume

(SEV)

Maxwell

®

16 Polyhistidine

Protein Purification Kit (Cat.#

AS1060)

Polyhistidine-

Tagged Protein

Research 

(Rsch)

Standard Elution

Volume

(SEV)

Maxwell

®

16 Total RNA

Purification Kit 

(Cat.# AS1050)

Total RNA

Research 

(Rsch)

Standard Elution

Volume

(SEV)

Maxwell

®

16 LEV Total RNA

Purification Kits 

(Cat.# AS1220, AS1225)

Total RNA

Research 

(Rsch)

Low Elution Volume

(LEV)

DNA IQ™ Reference Sample

Kit for Maxwell

®

16 

(Cat.# AS1040)

Forensic gDNA

Reference Samples

Forensic

(Fnsc)

Standard Elution

Volume

(SEV)

DNA IQ™ Casework Sample

Kit for Maxwell

®

16 LEV 

(Cat.# AS1210)

Forensic gDNA

Casework Samples

Forensic

(Fnsc)

Low Elution Volume

(LEV)

!

tm300.0208_Corrected.qxp  3/11/2008  10:41 AM  Page 27

Содержание Maxwell 16

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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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