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Merck Milliflex Quantum User Manual

Rapid detection system
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User Guide
Milliflex
Quantum
®
Rapid Detection System
The life science business of
Merck operates as MilliporeSigma
in the US and Canada.
SigmaAldrich.com

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Summary of Contents for Merck Milliflex Quantum

  • Page 1 User Guide Milliflex Quantum ® Rapid Detection System The life science business of Merck operates as MilliporeSigma in the US and Canada. SigmaAldrich.com...
  • Page 2 20. Standard Warranty the Reader Notice The information provided in this document (or any other literature) is subject to change without prior notice and shall not constitute a commitment of Merck or any of it’s Affiliates. Merck or any of it’s Affiliates expressly decline all warranties and shall not assume any responsibility for any errors that may appear in this document. This manual is believed to be complete and accurate at the time of publication. In no event shall Merck or any of its Affiliates be liable for all damages (including but not limited to incidental or consequential damages) in connection with, or arising from, the use of this document or associated literature.
  • Page 3 1. Introduction Milliflex Quantum System is a rapid fluorescence-based technology for fast quantitative ® detection of contaminants over a broad range of filterable matrices. This easy to use and simple system can detect viable microorganisms filtered on a membrane down to one CFU per sample. The non-destructive method allows the identification, by any method, of any microorganisms detected during the initial fluorescence reading. Sample preparation is performed by means of membrane filtration using the Milliflex system that ensures ® consistent and reliable results. 1.1 Chemistry of the reaction The Milliflex Quantum system uses proven technology based on a universal enzymatic ® fluorescent staining of viable microorganisms. After a filtration step with Milliflex Oasis sample preparation devices, all microorganisms ®...
  • Page 4 2. Operator and Equipment safety All employees who will operate and/or be near the Milliflex Quantum must comply with the following: ® • Read and understand the user guide of the Milliflex Quantum before using this Milliflex Quantum. Failure ® ® to follow operating instructions could result in user injury or damage to the instrument. • Do not attempt to open and repair the Milliflex Quantum. Service should be performed by trained and ®...
  • Page 5 3. S pecifications and Operating requirements Dimensions (nominal) Component Length cm (in.) Width cm (in.) Height cm (in.) Reader 24.9 (9.8) 14.2 (5.6) 12.5 (4.9) Reader Stand 30.7 (12.1) 18.0 (7.1) 13.5 (5.3) Camera 9.7 (3.8) 6.6 (2.6) 11.4 (4.5) Membrane Transfer Tool 5.7 (2) 5.7 (2) 3.2 (1.2)
  • Page 6 Materials of construction Component Materials of Construction Reader Housing Aluminum sheet 1050 with epoxy coating Optical chamber 304L stainless steel Handle 304L stainless steel Optical filter Glass LED protector Transparent polycarbonate Foot Polyvinyl Chloride (PVC) Labels Polyester Screen Protector Polyester Reader Stand Stand 304L stainless steel Foot...
  • Page 7 4. System components 4.1 The Milliflex Quantum reader and stand ® On/Off LED Power port RS232 port Counting button Drawer Viewing window Screen Stand 4.2 The Milliflex Quantum camera ® Status LEDs USB Port Camera Window Page 7 of 48...
  • Page 8 4.3 T he Milliflex Quantum membrane transfer tool for ® Milliflex Oasis system ® Head External gasket 4.4 T he Milliflex Quantum membrane removal tool for all ® Milliflex and Milliflex Oasis devices and media types ® ® Ejection tool Membrane separation lever Milliflex ®...
  • Page 9 4.5 The Milliflex Oasis pump ® Filtration head Pump control panel See the Milliflex Oasis Pump User Guide for details and instructions. ® 4.6 The Milliflex Quantum consumable kit ® Staining buffer Reconstitution reagent Fluorescent reagent Transfer pipettes Plastic storage bag The kit components must be stored at 2 to 8 °C. 48 tests can be performed with one Milliflex Quantum Consumable Kit.
  • Page 10 5. Installing the Milliflex Quantum reader ® The Milliflex Quantum reader weighs 4.4 kg (9.7 lb) and is designed for use on a ® laboratory workbench. 1. Remove all components and their accessories from the boxes. Remove the reader from the protective bag and place it on a flat, stable, horizontal surface.
  • Page 11 5. Connect the end of the power cord to the power outlet on the reader. LED power indicator 6. Connect the power cord to the external power supply. Connect the external power supply to a power source. The system will start up. 7. T he auto test sequence will run and verify that the Milliflex ®...
  • Page 12 6. Installing the Milliflex Quantum ® membrane transfer tool for Milliflex Oasis system ® NOTE: T he Milliflex® Quantum membrane transfer tool should be used in a microbiological safety cabinet or laminar flow hood. 1. P erform the daily maintenance on the Milliflex Quantum membrane transfer tool ® prior to use. Refer to the maintenance section for instructions. 2. Ensure that the external gasket does not twist and is fully seated in the groove. 3. R emove the Milliflex Oasis filtration head from the pump.
  • Page 13 7. P reparing the Milliflex Quantum ® membrane removal tool for all Milliflex and Milliflex Oasis devices ® ® and media types NOTE: T he Milliflex Quantum membrane removal tool should be used in a microbiological safety cabinet or ® laminar flow hood. Perform the daily maintenance on the Milliflex Quantum membrane removal tool prior ® to use. Refer to maintenance section for instructions. The Milliflex Quantum membrane ® removal tool is ready to use and requires no preparation. 8.
  • Page 14 9. Installing the software System requirements • Two USB ports • Minimum 512 MB of RAM memory, 1 GB recommended • Minimum disk space: 500 MB • Processor recommended: Intel Core™2 Duo ® • Minimum screen resolution 1024 x 768—recommended: 1280 x 1024 •...
  • Page 15 6. Select the language and the destination folder for the software. Click Next 7. A new window is displayed, listing the components required to complete the Milliflex ® Quantum software installation. Click Install. Page 15 of 48...
  • Page 16 8. When the operation is completed, click Next. 9. A message indicating that the software is now ready to be installed is displayed. Click Install. Page 16 of 48...
  • Page 17 10. A message indicating that the computer must be restarted in order to complete the installation of the software is displayed. Save and close all the other applications. Then, select Yes, restart the computer now and click Finish. 11. After the computer has restarted the QuantumSpotCounter icon is displayed on the desktop.
  • Page 18 12. Connect the small end of the USB cable to the camera. 13. The other end of the USB cable is equipped with two plugs. Connect the main plug to a USB port of the PC. Connect the second plug to another USB port of the PC, if available. plug (recommended) Main plug...
  • Page 19 10. Preparing the Reagent Kit 10.1 Precautions • Do not use any expired kit component. • Remove the kit from the refrigerator one hour before starting the reconstitution. • R econstitute under a laminar flow hood or a microbiological safety cabinet. • During the seven-day shelf life, do not let the staining solution remain at room temperature for more than four hours per day.
  • Page 20 11. Filtering Perform the sample filtration as described in the Milliflex Oasis system User Guide. ® 12. Incubating Place the media plate/membrane assemblies in the incubator, with the funnel cover facing down. 13. Staining 1. O nce the incubation is complete, remove the media plate/membrane assembly from the incubator and bring it under the laminar flow hood or the microbiological safety cabinet. 2. C lean the surface of the Milliflex Quantum membrane transfer tool with a non-woven ®...
  • Page 21 4. S ecure the Milliflex liquid cassette onto the Milliflex Quantum membrane transfer ® ® tool and remove the protective film from the Milliflex liquid cassette. ® 5. W ith a pipette, add 2 mL of staining solution on the center of the pad of the Milliflex ® liquid cassette. NOTE: G ently shake the staining solution before the first staining of the day. Do not touch the pad when adding the staining solution. Page 21 of 48...
  • Page 22 6. U sing the Milliflex Quantum membrane transfer tool, separate the membrane from ® the media plate as shown. • S lide the media plates/membrane assembly in the Milliflex Quantum membrane ® transfer tool following the arrow engraved on the tool until it blocks. • Hold the media plate/membrane assembly while lifting the lever. •...
  • Page 23 IMPORTANT NOTE If using Milliflex agar cassettes, use the appropriate adapter—labeled SOLID—located ® underneath the Milliflex Quantum membrane transfer tool. ® Align the Milliflex agar cassette/membrane assembly with the SOLID adapter’s notches ® as shown on the pictures below. Then separate the Milliflex agar cassette/membrane ® assembly as described at the beginning of this section. 7. P lace the membrane assembly with its cover onto the Milliflex liquid cassette. ® Page 23 of 48...
  • Page 24 8. Press the button to start the pump. 9. P ress firmly on both sides of the membrane assembly cover to lock it onto the Milliflex ® liquid cassette. This step allows even staining. Page 24 of 48...
  • Page 25 10. P ress the button to stop the pump and remove the membrane on the Milliflex liquid ® cassette from the tool. 11. I ncubate the membrane on the Milliflex ® liquid cassette for 30 minutes at 32.5 °C + 2.5 °C with the funnel cover facing down. NOTE: T he membranes on the Milliflex ® liquid cassettes should not be stacked in the incubator to ensure that all membranes are incubated at homogeneous temperature. Page 25 of 48...
  • Page 26 14. I nstalling the Milliflex Membrane in ® the Reader 1. A fter the staining step, remove the membrane on the Milliflex ® liquid cassette from the incubator. 2. Verify that the reader is on and ready to use. 3. O pen the reader drawer and place the membrane on the Milliflex ® liquid cassette in the drawer. 4. Close the drawer. Page 26 of 48...
  • Page 27 15. Reading the membrane 15.1 Reading the Membrane Manually NOTE: A ligning the membrane grid with the drawer will make counting easier. 1. O nce the reader drawer is closed, the reader lights the membrane. The screen displays the counter. 2. Push the counting button to increase the count. NOTE: A fter 10 minutes without opening the drawer, the LEDs inside the reader switch off and the system enters standby mode. To relight the membrane, open and close the drawer. This resets the counter. 3.
  • Page 28 NOTE: F ive seconds after opening the drawer, the counter disappears and the message Waiting for Milliflex ® is displayed on the screen. If the Milliflex Quantum reader is not used for more than 30 minutes with no Milliflex ® ® membrane inside, the reader goes into sleep mode. To reactivate it, push the counting button or open the drawer and insert a Milliflex ® membrane on a Milliflex liquid cassette. Close the drawer. When the reader is ® reactivated, the auto test sequence will run. 4. Close the drawer. Page 28 of 48...
  • Page 29 15.2 R eading the Membrane with the Milliflex Quantum ® Camera 15.2.1 Starting the Milliflex Quantum Spot Counter Software ® Double-click the icon on the desktop. The software opens. NOTE: I f the Milliflex Quantum camera is not connected, the message below is displayed before the ® opening of the software. The camera must be connected to the same USB port during installation and use. Otherwise the camera will not be recognized by the PC. Page 29 of 48...
  • Page 30 15.2.2 Capturing an image 1. C lick Capture (or Ctrl + space) after placing a membrane on the Milliflex liquid ® cassettes into the reader drawer. NOTE: D uring the image capture, the camera LED light is orange. A blinking orange LED indicates an error. 2. T he Milliflex membrane image is displayed. ® Page 30 of 48...
  • Page 31 15.2.3 Counting 1. P lace the mouse on the Milliflex membrane image. A cross appears on the screen. ® 2. Place the cross on a spot by moving the mouse. 3. Using the left button of the mouse, click the spots to mark them. The counter increases by one with each click.
  • Page 32 15.2.4 FullScreen Menu 1. Click the FullScreen menu to switch to the full screen mode. NOTE: W hen the FullScreen mode is activated, the counter value and the zoom factor are displayed in the toolbar menu, at the top of the screen. 2. Click the FullScreen menu to switch back to the normal mode. 15.2.5 Pen size Menu The pen size can be changed by clicking the Pen size menu. Four types of pens are available.
  • Page 33 15.2.6 Extrapolation Menu In applications with too many spots to count on the Milliflex membrane, the ® Extrapolation function can be used to estimate the number of colonies contained on the entire membrane. NOTE: A ctivating the Extrapolation function resets the counter. When using the Extrapolation menu, mark only the spots within the outlined segment. 1. C lick the Extrapolation menu. A one-eighth segment of the Milliflex membrane is outlined. ® 2. Count the spots in the outlined segment. 3. T he extrapolated number of spots for the entire Milliflex membrane is indicated at ®...
  • Page 34 15.2.7 Reset Menu Click the Reset menu to erase all the spot markings and reset the counter. 15.2.8 Saving an Image 1. Click the File menu. Select Save as menu 2. Select the folder to save the image in. 3. Select the format of the saved image (.bmp or .jpg). NOTE: .
  • Page 35 15.2.10 Opening a Saved Image 1. C lick the File menu and select Open. 2. B rowse the image to be opened and click Open. 3. O nce the image opens, the image functions are available. NOTE: T he Milliflex Quantum Camera does not need to be connected to open and work on a saved image. ® 15.2.11 Help Menu Click the Help menu and select Documentation menu. On the following window click the link to our website in order to download the Milliflex ® Quantum Rapid Detection System User Guide. Go to the section Reading the membrane with the Milliflex Quantum Camera of this ®...
  • Page 36 15.2.12 Closing the Milliflex Quantum Spot Counter Software ® Click File and select Exit. 15.3 Reincubation—optional 1. A fter reading the sample, separate the membrane from the Milliflex liquid cassette ® using the Milliflex Quantum membrane removal tool. Keep the cover on the ® membrane. 2. P lace the adapter for Milliflex cassette for liquid media—labeled LIQUID—located ® underneath the Milliflex Quantum membrane removal tool as follows: ®...
  • Page 37 3. S lide the membrane on the Milliflex liquid cassette in the adapter while blocking the ® adapter to prevent it from shifting. 4. Separate the membrane from the liquid media cassette as described in the staining section. 5. Remove the cover from a new media plate. 6.
  • Page 38 7. When the membrane is evenly spread, assure full membrane contact with the media plate by pressing slowly and firmly on both sides of the membrane. The membrane should be fully in contact with the medium. 8. T ake the Milliflex liquid cassette out of the adapter using the Milliflex Quantum ® ® membrane removal tool as a guide. Place the media plate/membrane assembly in the incubator, with the funnel cover facing down.
  • Page 39 16. Storing the reader If the reader will not be used for an extended period of time, close the drawer and unplug the power cord from the power source. 17. Maintenance 17.1 Cleaning recommendations 1. Disconnect the reader from the power supply before cleaning or servicing. 2. D o not spray any cleaning products, solvents or abrasives on or in the Milliflex ®...
  • Page 40 17.2.2 Milliflex Quantum camera ® Clean the window of the Milliflex Quantum Camera using a non-woven wipe soaked in ® one of the products listed in the Cleaning recommendations section. 17.2.3 Milliflex Quantum Membrane Transfer Tool ® 1. B efore the first transfer of the day, gently clean the surface of the Milliflex Quantum ® membrane transfer tool with a non-woven wipe soaked in one of the products listed in the Cleaning recommendations section.
  • Page 41 17.2.4 Milliflex Quantum Membrane Removal Tool ® Clean the Milliflex Quantum membrane removal tool using a non-woven wipe soaked in ® one of the products listed in the Cleaning recommendations section. NOTE: T he Milliflex ® Quantum membrane removal rack can be autoclaved at 121°C for 15 minutes or at 134 °C for 5 minutes. 17.3 Weekly Servicing 17.3.1 Milliflex Quantum Reader ® Disinfect all the exterior surfaces of the reader, the stand and the camera using a non-woven wipe soaked in one of the products listed in the Cleaning recommendations section.
  • Page 42 3. Invert the Reader. Gently clean the interior of the reader using a non-woven wipe soaked in one of the products listed in the Cleaning recommendations section. 4. R eplace the drawer inside the Milliflex Quantum Reader. ® 17.5 Semi-annual servicing 17.5.1 Milliflex Quantum Membrane Transfer Tool ® Replace the external gasket on the Milliflex ®...
  • Page 43 17.7 Cleaning and maintenance table Installation Before use After use Weekly Monthly Yearly Milliflex Quantum membrane transfer tool ® Surface External Seal Internal Seal Spare parts Maintenance replacement Milliflex ® Quantum membrane removal tool External surface Milliflex Quantum reader ® External surface Internal...
  • Page 44 18. Troubleshooting Error Message or Symptom Possible Cause Remedy Milliflex Quantum Reader ® Connect to power source. The light (LED) and the screen on The reader is not connected to power If the reader is connected to a power source and the reader are off.
  • Page 45 Error Message or Symptom Possible Cause Remedy Verify that the camera is correctly placed on the reader. Verify that the reader is connected to power source. Verify that the membrane is inserted in the reader with a Milliflex ® liquid The membrane Nothing to capture! cassette or a solid media adapter below and the funnel cover above. is not or not Check your reader.
  • Page 46 19. Spare parts, accessories and services Description Qty/Pk Catalogue No. Milliflex Quantum System Kits ® Milliflex ® Quantum standard kit which includes 1 reader, 1 reader stand, 1 membrane transfer MMQUANK01 tool, 1 membrane removal tool, and 1 camera Milliflex Quantum standard kit with validation protocol European format which includes: 1 reader, ®...
  • Page 47 20. Standard Warranty We make no warranties of any kind or nature, express or implied, including any implied warranty of merchantability or fitness for any particular purpose, with respect to any technical assistance or information that we provide. Any suggestions regarding use, selection, application or suitability of the products shall not be construed as an express or implied warranty unless specifically designated as such in a writing signed by an officer or other authorized representative of our company.
  • Page 48 Merck KGaA Frankfurter Strasse 250 64293 Darmstadt, Germany SigmaAldrich.com/Quantum © 2020 Merck KGaA, Darmstadt, Germany and/or its affiliates. All Rights Reserved. Merck, the vibrant M, Millipore, Sigma-Aldrich, Lit. No. MK_PG5589EN Ver. 3.0 Milliflex, and Milliflex Oasis are trademarks of Merck KGaA, Darmstadt, Germany or its affiliates. All other trademarks are the PF11940 property of their respective owners. Detailed information on trademarks is available via publicly accessible resources. 2019 - 26936 08/2020...