Table of Contents Safety ........................4 Voltage Safety Interlock Pipette Heads Tip Waste Container Tray Liquids Replacement Parts Introduction ......................6 Standard Equipment Documentation Protocols Disposables Technical Specifications Setup/Operation ....................9 III. Unpacking Removable Tray Rear Panel Connections Front Panel Connections UPS Battery Power and Line Conditioner Power On and Start Up Log In User Management Touchscreen Overview Alignment Protocol Add Pipette and PickPen Head(s) Set Date & Time Install Chime Sound Box Run a Protocol Step‐by‐step Wizard ASSURANCE GDS® PPMX USER MANUAL ...
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Pause or Stop a Running Protocol View Results Run Report Log Out LIMS Compatibility Import Protocol Export Protocol Delete Protocol Change PPMX Serial Number in Software Troubleshooting ....................23 Communication Loss Re‐starting a Protocol after Communication Loss Hood Open Reporting an Error Technical Services Maintenance ....................... 25 Cleaning Pipette Head Calibration Alignment Calibration Preventative Maintenance Warranty Instrument Return Procedure Appendix A ......................27 Parts List Appendix B ......................29 VII. Before You Call Us Appendix C ......................30 VIII. Maintenance Log Appendix D ......................
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Best Practices Appendix G......................35 XII. Pack Up Appendix H ......................39 XIII. Ordering Information ASSURANCE GDS® PPMX USER MANUAL ...
Safety Read this section before installing and operating the Assurance GDS® PPMX. This instrument is intended to be used in a laboratory environment by trained technical personnel. For safe and proper use of this instrument, it is required that both operating and service personnel follow the instructions contained in this guide when installing, operating, cleaning, and maintaining the instrument. The following safety precautions must be observed during all phases of operation, service, and repair of the instrument. Failure to comply with these precautions or with specific warnings elsewhere in this user’s guide violates safety standards of design, manufacture, and intended use of the instrument. BioControl Systems assumes no liability for the customer’s failure to comply with these requirements. The PPMX has been certified to safety standards required in Canada, Europe, and the United States. Refer to the instrument rear panel label and the Declaration of Conformity document for the current standards to which the instrument has been found compliant. The following electronic and hazard symbols may appear on the instrument: The following safety notices may appear in this document: Voltage Access to the rear panel is necessary because the instrument must be detached from all voltage sources before service, repair, or exchange of parts. Operate the instrument using the approved power supply provided and only at the voltage specified on the rear panel label of the instrument. ASSURANCE GDS® PPMX USER MANUAL...
The instrument is capable of generating significant forces that could cause potential injury to the user. For an instrument with the rotating cover installed, the safety interlock in the cover will disable the instrument movement if the cover on the instrument is open. For an instrument installed in a hood, the external safety interlock sensor mounted on the instrument will disable the instrument movement if the hood door is open. Tip Waste Container The tip waste container should be emptied in accordance with national and local safety regulations. Tray The moving tray is capable of causing injury by pinching. For an instrument with the rotating cover installed, the safety interlock in the cover will disable the instrument movement if the cover on the instrument is open. Liquids Observe safe laboratory practices when handling liquids. If working with biological samples or chemical substances, ensure that there is proper ventilation, and wear personal protective equipment (PPE), such as safety glasses, gloves, and protective clothing at all times. Refer to the Safety Data Sheets for solvents before use. Replacement Parts Be sure to use only replacement parts specified in this user manual. Do not repair or change parts which are not listed in this user manual. If it is necessary to change parts not listed, please contact BioControl Systems technical services. ASSURANCE GDS® PPMX USER MANUAL...
Introduction The Assurance GDS PickPen® PIPETMAX® (PPMX) is an automated magnetic particles and liquid handler. It is capable of dispensing Assurance GDS reagents which include, Concentration Reagent, Wash Solution, Resuspension Buffer and select media (BHI/DFB). Reagent dispense protocols have been created for all Assurance GDS assays. In addition, the PPMX has also been programmed to automate Assurance GDS PickPen Immunomagnetic Separation (IMS) procedures. This user manual is intended to assist PPMX users with system start‐up, basic operation, maintenance and service. Standard Equipment After the PPMX and accessories are unpacked, the following items should be present: PPMX Instrument with rotating cover • Alignment Head • Removable Tray 96 well • Pipette Tip Reload Rack • PickPen Tip Reload Rack • Tip Disposal Bin • Power Supply (110V/220V) • Power/USB Cabling kit • Power Cords (US and EU) • USB Cable • • Back Plug, Black • Allen Wrench, 5 mm • MAX8x200 Pipette Head • Assurance GDS PickPen Magnetic Head • Assurance GDS Reagent Holder •...
System also comes with either: Control Tablet with TRILUTION micro software pre‐loaded + Charger and Tablet holder • or Microsoft Surface laptop with TRILUTION micro software pre‐loaded + Charger and Keyboard cover/Pen • These items come with US plugs only. For part numbers, refer to Appendix A, Parts List. For ordering information, refer to Appendix H, Ordering Information. Documentation The following documents are included with the PPMX: • PPMX User Manual Gilson Quick Setup Guide • • Gilson Installation and Operational Qualification (IQ/OQ) Procedures Gilson Declaration of Conformity • Gilson Validation Certificate for TRILUTION micro • Gilson Quality Control Report Pipette Head • Protocols Alignment Protocol • • Assurance GDS Reagent Dispense protocols (R‐) Assurance GDS PickPen IMS protocols (IMS‐) • • Assurance GDS Combined Reagent and IMS protocols (C‐) Disposables The items below are sold separately but are required for use: 200 µL Sterile Blister Filter Tip Packs •...
Technical Specifications Please be aware of the following before operating the PPMX. Changes or modifications to this device not expressly approved by BioControl Systems could void the warranty. The instrument complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This instrument may not cause harmful interference, and (2) this instrument must accept any interference received, including interference that may cause undesired operation. Shielded cables must be used with the instrument to ensure compliance with the FCC Class A limits. Technical Specification Definition Communications USB Connections Three USB host ports and one USB device port Two inputs (contact closure, TTL), two relay outputs, and one switched +12V DC 1A output NOTICE: Switching voltages higher than 30V or greater than 1A of current may damage the instrument. Dimensions & Weight W 54.4 X D 65.5 X H 53.1 cm (21.4 X 25.8 X 20.9 in), 24.9 kg (55 lbs.) ...
Setup/Operation The Assurance GDS PPMX and its components should be set up in the order described in this section. Gilson TRILUTION® micro provides software control of the PPMX during setup and operation as described in this section. For more information about TRILUTION micro, view the help information in the software, accessible from the button. Unpacking The PPMX is delivered with most major components already assembled. Please keep the original packaging (both internal boxes and the external crate) in case the PPMX needs to be returned to BioControl Systems for repair. It is recommended that two people lift the PPMX out of the box, as it weighs approximately 55 lbs. (24.9 kg). Open the crate by unscrewing the 4 bolts at the bottom of the crate (located just above the pallet). Use a 9/16” wrench if needed. Lift straight up using handles on both sides. Remove the two grey foam pieces. Remove the closed and open‐ended cardboard accessories boxes by sliding them out from the bungee cords. Be careful not to drop the boxes while disassembling the cords. Remove the plastic bag covering the PPMX. Grip the PPMX at the recesses near the base. There is one recess in the front, one in the back, and one on each side. Use these recesses when lifting the PPMX out of the foam‐lined tray. Do not attempt to lift the PPMX from the cover or from the X‐arm (the horizontal arm). Always lift the instrument from its base. Place the PPMX on a stable, level surface such as a lab bench, lab cart. Refer to Section 1: Safety. Remove the blue film or lab tape protecting the rotating cover. Remove the shipping brace from the rear of the instrument. Loosen the thumb screws securing the shipping brace to the PPMX. After removing the shipping brace, replace and tighten the thumb screws ...
Remove the shipping bracket that attaches the arm to the inside of the unit using the allen wrench (5 mm) provided. Note: Some older units have 2 clear tubing pieces that are wrapped around the lead screw instead, these should be removed and saved. 10 Remove the white foam block preventing the tray from moving. 11 Place all packaging materials inside the crate for long‐ term storage. DO NOT TROW AWAY the interior cardboard boxes as these are custom made for the PPMX. Keep the shipping brace, shipping bracket, allen wrench and foam block with the packaging. Removable Tray A removable tray for placement of labware and tip racks is required. While holding the handles on the sides of the tray, lower the tray onto the metal carrier. It is keyed and will only mount one way. Observe that the tray is level and fully seated on the metal carrier. Rear Panel Connections Refer to the diagrams on the next page when making the connections described in this section. The input/output contacts on the rear panel are used for communication between the alignment head and TRILUTION ...
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DC Power Output – The top terminal block has one +12V DC output, which is labeled. The PPMX has one functional USB host port (the middle port) on the rear panel. The top port on the rear panel is not supported. The USB ports can be used to connect USB drives (which can also be seen by the tablet when plugged into the PPMX), keyboard, mouse, or any other compatible device (heater/chiller, barcode scanner, or shaker, for example). The USB device port is used for communication between the PPMX and the tablet or computer. A USB cable is provided as a standard accessory. Refer to the diagram for the location of the USB device port. The Ethernet Port, RS‐232 and HDMI are not supported. Input/Output (Green) USB host (Not Supported) USB host Ethernet (Not Supported) USB device RS‐232 (Not Supported) HDMI (Not Supported) Power receptacle Power switch (MAINS) Use the power cord on the external power supply to make the connection between the power receptacle on the PPMX and the external power supply. The connection from the external power supply to the PPMX uses a connector with a locking collar. Check the alignment of the pins and then push it in until it clicks and locks in place. To disconnect, pull back on the locking collar and then disconnect the cable from the rear panel of the PPMX. Locate the appropriate power cord for your line voltage and then make the connection between the external power supply and the AC power source. Install the Power/USB Cabling kit by following the supplied instructions. ASSURANCE GDS® PPMX USER MANUAL...
Front Panel Connections The PPMX has two functional USB host ports on the front panel. The USB ports can be used to connect USB drives (which can also be seen by the tablet/laptop when plugged into the PPMX), keyboard, mouse, or any other compatible device (heater/chiller, barcode scanner or shaker, for example). In a situation where an emergency stop is required, pressing the STOP button stops the PPMX immediately. The protocol stops and results are displayed (after touching OK on the prompt). USB host STOP UPS Battery Power and Line Conditioner To prevent fluctuations in power to the PPMX and tablet/laptop, it is recommended that the following UPS battery backup be used with the system: Tripp Lite SU750XL or equivalent Additionally, it is recommended that the PPMX be placed on a separate circuit from other equipment. Power On and Start Up To start the PPMX: Make sure that the PPMX is connected to the external power supply and that the external power supply is connected to a power source. Turn power on at the external power supply (O is off, I is on). Turn the PPMX power on using the MAINS power switch located on the rear panel. The indicator light on the front panel will illuminate green. Connect the control tablet/laptop to the PPMX and power it on. Close the rotating cover door. The PPMX will not operate with the cover open. Log In When prompted, enter the “User name” and “Password”, and then select Accept (or the X to cancel). Password is case‐sensitive. It is recommended to change the password for the default Administrator (admin). Select the “User name (Full name)” in software to go to the “User properties” screen. ...
User Management The user management feature in TRILUTION micro provides a way for administrators to grant or restrict users access to programs and features in the software. User management is accessible from the main screen shown when the software starts. Select Manage Users in software to go to the “User management” screen, which displays a list of users. Select a user from the list. Select Edit. The “User properties” screen appears. Edit any or all properties shown. • “User name” may not be modified for the logged in user. For the default administrator (admin), only “Password” • and “Feature permissions” may be modified. Select Save, or Back to return to the previous screen without saving. To add a user (Administrators only), select Add and the “New user” screen appears. Enter a User Name. The user name cannot be the same as any other user name. • The user name can be from 1 to 50 characters in length, must begin with an English letter or • number and may contain the following special characters: _()‐@.and,. Spaces are valid. Enter the Full name for the user. • The full name can be from 1 to 100 characters in length, must begin with an English letter or number and may contain the following special characters: _()‐@.and,. Spaces are valid. Optionally, enter a “Password” for the user. The user can change the password at any time. It can be from 1 to 50 characters in length, must begin with an English letter or number and may • contain the following special characters: _()‐@.and,. Spaces are valid. It is case‐sensitive, but it is not required (password can be blank). •...
Touchscreen Overview The following information provides an explanation of unique software interactions when running TRILUTION micro on the touchscreen control tablet. It is recommended to keep the tablet plugged into a power source whenever possible. Communication errors can occur between the PPMX and control tablet if the battery runs too low. Refer to the table below for a description of the icons used in the on‐screen keyboard. The following icons appear on several screens in TRILUTION micro. To view the options to shut down the control tablet and/or TRILUTION micro, touch on the main menu: Touch Shutdown to close TRILUTION micro and shut down the control tablet. • • Touch Restart TRILUTION micro to restart only the software, and not the control tablet. Touch Cancel to go back to the main menu. • ASSURANCE GDS® PPMX USER MANUAL...
Alignment Protocol Run the Alignment Protocol to ensure proper alignment of the PPMX. It is only necessary to run this protocol when setting up the instrument for the first time after a move or if an alignment issue is suspected. Pass the end of the alignment cable cord with pre‐wired connector through the outlet at the back of the PPMX. Be sure to go under the lead screw to allow for the full range of motion. The connector is labeled BOTTOM because it connects to the bottom set of green input/output ports on the rear panel of the PPMX. Make the connection. The clips to secure the tip racks on the tray can interfere with the alignment. Ensure that the clips ( ) are positioned as shown in the diagram below, and that the thumbscrews have been tightened. Close the rotating cover. The tablet starts TRILUTION micro automatically on power up. If using a laptop, double click the TRILUTION micro icon to start the software. Select Run/manage protocols. Ignore the “Create protocol” and “Start utility” bars. Select Run a protocol. Select Alignment Protocol and then select Next. ...
14 Select Continue. 15 Select Home to go to the main menu Add Pipette and PickPen Head(s) Each head that may be used now, or in the future, must be added per the instructions that follow. On the TRILUTION micro main menu, select Settings. On the Settings menu, select Pipette heads. Enter the serial number located on the pipette head and the pipette type (i.e. 8x200). The PickPen head is added the same way using serial number HN12017. All PickPen heads use this same serial number in the software (they are physically serialized on the back for tracking purposes). Choose PickPen II as the type. Select Save. There will not be a message that the settings were saved. Repeat steps 3 – 5 for additional heads. When finished adding heads, select Back. Set Date & Time Set the date and time to ensure a correct date/time stamp on protocol runs. This should only have to be done once. On the Settings menu, select Date/time, and then set the date, time, and time zone. Install Chime Sound Box To enable sound on the PPMX, a separate chime sound box can be added to the back of the instrument per the instructions that follow: Plug the green phoenix connector into the top green input/output port on PPMX rear panel. Position the sound box on the back center, above the shelf portion of the PPMX and secure the plastic holder using the provided hardware (the shorter screws are used on the top holes). If there are already screws in the locations specified, remove these first. Adjust the volume using the volume dial. There is also a reset button on the inside of the speaker. To use, push and then reboot the PPMX system. Volume dial ...
Run a Protocol The Labware setup guide screen displays the options for confirming the instrument setup. Select Step‐by‐step wizard to do all of the following (in the order shown): • Review a list of the materials. • Review the layout of the tray and set up pipette head. Set up the pipette, tip rack and additional labware. • • Review protocol / deck. For details, refer to Step‐by‐step Wizard on the next page. Select Browse positions manually to do any of the following: Review the layout of the tray and review pipette head. • • Select and set up specific labware. Review protocol / deck. • Select Skip setup to skip setup instructions and go to the Wizard complete screen. Protocol will be set to the default values or the values used the last time the protocol was run. This includes the number of samples and tips in the reload block. Step‐by‐step Wizard Select to go to the main menu. Select Run a protocol. Select your protocol, and then select Next. The Scanning dialog appears while the software checks that the PPMX is connected. If connected, the software goes to the next screen. If not connected, a message will appear suggesting possible solutions. Enter sample number, kit and reagent information manually or using a barcode reader and then select Next. Select Step‐by‐step wizard. Gather the materials in the Materials List and then select Next. Wait for the software to finish “Preparing pipette head” and then open the rotating cover. ...
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Each tip rack consists of a tip pack and a tip reload block. To assemble the tip rack: Open the sealed blister pack. Lift the tip pack out of the blister pack. Set the tip pack on the tip reload block. Ensure that the tip pack is fully seated on the tip reload block. Mark the clear cover with an X and remove. Save the clear plastic box and cover on hand for unused tips. To install the tip rack: Loosen the elbow thumbscrew for each clip. Place the tip rack on the removable tray with the beveled corner in the back left corner. Rotate each clip so that it will effectively secure the tip rack on the tray as shown in the image below. Tighten the elbow thumbscrew for each clip. Pipette tips are used from the bottom right and moving up the column. U se the Tip Mover to load the PickPen tips from the tip racks (the tip mover can also be used to refill pipette tip racks). PickPen tips are used from the top left and moving down the column. NOTE: Always refill the pipette and PickPen tips off the deck to prevent tips from falling into the open instrument tracks. Place Sample Block(s) with the BioControl label on the left side, strips are filled starting in the top left well moving down a column. Place the Resuspension Plate(s) with the A1 in the top left corner, columns are filled starting in the top left well moving down a column. RS Plate columns are filled in a skipped pattern similar to the manual process. The reservoir(s) should also be placed so that the A1 is in the top left corner. ASSURANCE GDS® PPMX USER MANUAL...
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Place the Assurance GDS Reagent Holder on the deck so that the smaller hole is on the top left side a Standard Concentration Reagent bottle (a) b High Throughput (HT) Reagent bottle (b) If using the standard bottle, select False. If using the HT bottle, select True. There are indentations for the CR bottle lids on the holder. Place the Gel Cooling Block so that the brand name is to the front right side. Place the HT Amplification Tube Block with the slide bar on the left side. Slice the amp tubes and expand the plate prior to adding the lid. 15 If individual sample IDs need to be entered for each sample in the sample block, this can be done manually or using a barcode reader. Select the sample that matches the location on the sample block, highlight the information in the field and either manually type the sample ID or use the barcode reader to import the information for each well. The sample selected will be highlighted on the sample block. Samples are listed in rows starting with A1. 16 Review protocol / deck and then select Next. 17 Select Run protocol. 18 When prompted, Skip simulation request. ...
Pause or Stop a Running Protocol While running a protocol from TRILUTION micro, click or touch anywhere on the PIPET STATUS image to pause the run. The run will stop when it finishes its current action. The protocol run timer keeps advancing during the pause. When prompted, select Continue to resume the run, or Stop to end the run and view the results. Do not pause the protocol while pipette tips are being picked up or ejected. To stop the PPMX in an emergency, press the red STOP button on the front of the PPMX. This action will automatically end the current protocol run. View Results During and after a protocol run, information is available about reagent dispense volumes. After a protocol run, results for that run are automatically displayed. To view results: Select to go to the main menu. Select Results. Select a protocol, and then select Results. Select a protocol run, and then select View. Simulated runs are identified by The first screen displayed when viewing results is the Tray view screen. The colors indicate the following information: Red – Negative volume Green – Volume in the tube or well Blue – Empty tube or well Pink – Tips The top of the screen shows the status, the name of the protocol, the time it took to run or simulate the protocol and generate the results, and the time of execution for the last step. The Volume view screen displays information about the volume in the selected well or reservoir. The top of the screen shows the status, the name of the protocol, the time it took to run or simulate the protocol and generate the results, and the time of execution for the last step. The text above the table lists the bed element name, the well location and label, and the current volume in the well. The table lists the actions that occurred in the well or reservoir in the following order: Initial volume (if any) Volume added and the source of the volume added (bed element name and plate index or reservoir number) Volume removed 10 The Steps view screen displays the steps that were run in the protocol in the order of execution. 11 The top of the screen shows the status, the name of the protocol, the time it took to run or simulate the ...
Run Report The Run Report is a subset of the results and can be exported for viewing from the control tablet or laptop. It cannot be viewed from within the software or on the tablet. It includes basic information about the protocol run, the bed layout, and well tracking. It does not include the information about volume tracking. Select to go to the main menu. Select Results. Select a protocol, and then select Results. Select a protocol run, and then select Export. Select the file type for the exported file: .htm (default), .xml or .csv. Browse for and select the USB drive, name the file (or accept the default name, which is the name of the protocol), and then touch Save. The Run Report is saved to the location. Open the file on a laptop or desktop computer. Log Out Select to go to the main menu. Select Return to TRILUTION micro. Select Log out to allow another user to log in to the software. LIMS Compatibility The PPMX is LIMS compatible when using a network enabled laptop. To import data from a LIMS system, the following steps should be followed: Select Start utility. Select LIMS Assistant. Select IMPORT. Browse to select the LIMS import file for the PPMX protocol being run. Select Import. A notice will appear saying import was successful. Minimize LIMS Assistant program window. Select Run/manage protocols. Select Run a protocol. Select your protocol, and then select Next. The Scanning dialog appears while the software checks that the PPMX is connected. If connected, the software goes to the next screen. If not connected, a message will appear suggesting possible solutions. 10 The sample number and reagent information will appear in the appropriate fields automatically, and select Next. 11 Select Step‐by‐step wizard and follow prompts. ...
Import Protocol To import a protocol: Select to go to the main menu. Connect a USB drive containing the protocol file to one of the USB ports on the front of the PPMX or the middle USB host port on the rear panel (the top USB port on the rear panel is not supported). Select Manage protocols to go to the listing of protocols. Select Import and then browse for your application protocol file (.sqlite) on the USB drive. Select the file and then select Open to import the protocol file. Export Protocol To export a protocol (and its results): Select to go to the main menu. Select Manage protocols to go to the listing of protocols. Select a protocol in the list. It will highlight when selected. Select Export. Browse for and select the destination (USB drive) for the protocol file, and then select Open. The protocol is saved to the location with a .SQLITE extension. Delete Protocol To delete a protocol (and its results): Select to go to the main menu. Select Manage protocols to go to the listing of protocols. Select a protocol in the list. It will highlight when selected. Select Delete. Change PPMX Serial Number in Software To control a PPMX from TRILUTION micro, the serial number of PPMX must be entered into TRILUTION micro software. When TRILUTION micro is factory‐installed on the supplied tablet/laptop, the serial number of the corresponding PPMX is entered into the software. If installing a replacement computer, follow the instructions below. Go to the HOME screen. ...
Troubleshooting TRILUTION micro will display a message if a known error is encountered. This section describes some of the more common errors and how to prevent or resolve them. Communication Loss If a message appears that indicates that the PPMX cannot be found, check your settings (including serial number) and cabling. To re‐establish communication try the following: Turn off the PPMX. Turn off the tablet (press the power button on the HOME screen, then select Turn off tablet) or laptop. Unplug the PPMX from the computer and disconnect the PPMX power cord from the unit. Plug the computer into the power source to ensure the battery is charging. Wait 5 – 10 min. Reconnect the PPMX to the power supply and the computer to the PPMX. Power the PPMX on first. Power the computer on. Proceed with selecting Run a protocol to check communication has been re‐established. Re‐starting a Protocol after Communication Loss If during a protocol there is a loss of communication between the computer and PPMX, the pipette head may be frozen in position. To manually reset the pipette head: From the error message, choose “go to Manual control” or restart the protocol Step‐by‐step wizard and follow prompts but instead of Run protocol, select Manual control. Check the box “Home in recovery mode” and select Home XYZ. Pipette should return to the home position. Hood Open Close the rotating cover door. The PPMX will not operate with the cover or hood door open. While the run is in progress, DO NOT open the hood; however, if the hood has been opened, you will see the following message. If you choose to continue the run, close the rotating cover door and then observe that the run ...
Reporting an Error If an error window appears during a protocol, follow the instructions below: Scroll to the bottom of the error box and take a photo or write down the additional Detail text information. This information is important for Technical Services to be able to adequately diagnose the issue. From the error message, select Manual control. Check the box “Home in recovery mode” and select Home XYZ. Pipette should return to the home position. Technical Services If you need assistance, please contact BioControl Systems Technical Services at 425.603.1123 or techservices@biocontrolsys.com. To help us serve you quickly and efficiently, please refer to Appendix B. Before Calling Us. ASSURANCE GDS® PPMX USER MANUAL...
To ensure proper performance of the PPMX the following routine cleaning procedures should be performed on a regular basis. It is recommended that these procedures be carried out at least weekly following reagent dispense protocols or after each run following PickPen IMS protocols. However, based on the specific laboratory environment, more frequent cleaning may be necessary. Always turn the power off to the PPMX before cleaning. To clean the PPMX, lightly spray 70% isopropyl alcohol onto a paper towel and wipe the following non‐ disposable items: Removable Tray Pipette Head(s) [avoid introducing any liquid into the openings at the bottom] Tip Reload Rack(s) PickPen Magnetic Head [avoid introducing any liquid into the openings at the end of the carrier sleeves…exposure of magnets or the inside of the carrier sleeves to moisture may result in corrosion, preventing the device from operating properly] GDS Reagent Holder GDS Sample Bases The Tip Disposal Bin(s), Gel Cooling Block(s), HT Amp Tube Block and Lid (if applicable) should be cleaned by lightly spraying a paper towel with 10% bleach solution and wiping the outside surface. Follow with 70% isopropyl alcohol as described above to remove potentially corrosive residues. All disposable reservoirs can be autoclaved. To clean the computer, wipe the screen with a low lint cloth designed for electronics. Do not use pre‐moistened alcohol or bleach wipes to clean the tablet/laptop screen. Leave rotating cover down when instrument is not in use. For a maintenance log, please refer to Appendix C. Maintenance Log. Pipette Head Calibration To ensure proper performance of the pipette head cassette, it should be calibrated annually as a minimum. Contact BioControl Systems Technical Services at 425.603.1123 or techservices@biocontrolsys.com. To help us serve you quickly and efficiently, please refer to Appendix B. Before Calling Us. It may be necessary to exchange pipette head cassettes while one is out for calibration. When exchanging a pipette head it is necessary to do two things: Add the pipette head to the software by scanning or entering the calibration values. For detailed instructions, refer to Add Pipette Head(s). Physically install the head on the instrument. For detailed instructions and a diagram, refer to Step‐by‐ step wizard. ASSURANCE GDS® PPMX USER MANUAL...
To verify the pipette head performance, please refer to Appendix E. Pipette Verification. ISO 17025 calibrated pipette heads are also available from Gilson for an additional cost, please contact BioControl Systems Technical Services for additional information. Alignment Calibration It may be necessary to run the Alignment Protocol to ensure proper alignment of the PPMX if the unit is moved or an alignment issue is suspected. For detailed instructions and a diagram, refer to Run Alignment Protocol. Preventative Maintenance To ensure proper performance of the PPMX it is recommended that a preventative maintenance (PM) field visit be scheduled annually. This PM consists of the following: Cleaning polyurethane running pads beneth fixed deck tray Testing of removable tray for correct positioning Cleaning/greasing the X rail Cleaning/greasing the Y rails Cleaning/greasing the Z lead screw Cleaning/greasing the Z rails Internal and external surface cleaning Inspecting the X belt for excessive wear and proper tension Inspecting tray elements for excessive wear Re‐alignment of system Contact BioControl Systems Technical Services at 425.603.1123 or techservices@biocontrolsys.com to schedule. To help us serve you quickly and efficiently, please refer to Appendix B. Before Calling Us. Warranty Units that are under warranty will be repaired and returned to the user at no charge. Please refer to Appendix D. Warranty Terms. If you have any questions about applicability, contact your local BioControl Systems representative. For out‐of‐warranty repairs, contact your local BioControl Systems representative who will discuss service options with you. Instrument Return Procedure Contact BioControl Systems Technical Services at 425.603.1123 or techservices@biocontrolsys.com to obtain authorization before returning any BioControl Systems equipment. To help us serve you quickly and efficiently, please refer to Appendix B. Before Calling Us. To return a piece of equipment: ...
Appendix A Parts List Equipment Description BCS Part Number 79100 ASSURANCE GDS PPMX WITH STANDARD COVER 79120 CONTROL TABLET WITH BCS TRILUTION MICRO SOFTWARE 79104 CONTROL TABLET HOLDER 79145 MICROSOFT SURFACE PRO 4 LAPTOP WITH BCS TRILUTION MICRO SOFTWARE 79146 MICROSOFT SURFACE KEYBOARD COVER 79158 MICROSOFT SURFACE PRO 4 PEN 79110 ALIGNMENT HEAD 79115 POWER SUPPLY 110V / 220V 79112 POWER CORD US 79113 POWER CORD EU 79116 USB CABLE 79147 PPMX PWR AND USB CABLING KIT 79121 BLACK PLUG FOR BACK COVER 79131 ALLEN WRENCH, 5 MM 79101 REMOVABLE TRAY 96 WELL 79105 PIPETTE TIP RELOAD RACK 79173 PICKPEN TIP RELOAD RACK 79109 TIP DISPOSAL BIN ...
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Disposables Description BCS Part Number 79102 DIAMOND BLISTER, DF200ST, FILTER, 960 TIPS 79107 4‐COLUMN REAGENT RESERVOIR, CASE OF 25 79119 1‐COLUMN REAGENT RESERVOIR, CASE OF 25 73087 ASSURANCE GDS PICKPEN II TIPS, RACKED 73085 ASSURANCE GDS PICKPEN II TIPS, BULK 73004 ADHESIVE FILM SHEETS, BOX OF 100 73026 ADHESIVE FILM STRIPS, BOX OF 200 73043 SAMPLE WELL BASE, BAG OF 10 73044 SAMPLE WELLS, BAG OF 200 73006 RESUSPENSION PLATES, CASE OF 120 ASSURANCE GDS® PPMX USER MANUAL...
Appendix B Before You Call Us BioControl Systems Technical Services will be able to serve you more efficiently if you have the following information on hand: Serial number of the instrument(s) involved: • The serial number for the PPMX is located on the inside panel of the right support. The serial number for the pipette head is located on the front outside casing. The serial number for the PickPen magnetic head is located on the back outside casing. The serial number for the control tablet is located on the outside of the box. The serial number for the Surface laptop is located behind the support at the bottom. List of concise symptoms being exhibited by the instrument. • List of operating procedures / protocols and conditions you were using when the problem arose. • Be prepared to email the exported protocol that was running when the issue occurred, refer to Export • Protocol. • List of all instruments in the configuration and the connections to those instruments. • List of other electrical connections in the room. ASSURANCE GDS® PPMX USER MANUAL...
Appendix D Warranty Terms BioControl Systems, Inc. (“BioControl” or “BCS”) warrants the Assurance GDS PickPen PIPETMAX automation equipment to be free from defects in materials and workmanship, when given normal, proper, and intended usage for one (1) year from the date of delivery of this equipment to the original purchaser (“Buyer”). BioControl agrees during the applicable warranty period to repair or replace, at BioControl’s option, all defective equipment within 5 days after date of return to BioControl and without cost to Buyer. This Limited Warranty shall apply to the following EQUIPMENT included in the Assurance GDS PIPETMAX System; Assurance GDS PickPen PIPETMAX and control tablet. BioControl shall not have any obligation under this Limited Warranty to make repairs or replacements which are required by normal wear and tear, or which result, in whole or in part, from catastrophe, fault or negligence of the Buyer, or anyone claiming through or on behalf of the Buyer, or from improper use of the equipment, or use of the equipment in a manner for which it was not designed, or by causes external to the equipment. Buyer shall notify BioControl of any equipment believed to be defective during the warranty period. At BioControl’s option, such equipment shall be returned by Buyer, transportation and insurance prepaid, to BioControl’s designated facility for examination and testing. BioControl shall repair or replace, within 5 days of receipt by BioControl, any such equipment found to be defective and promptly return such equipment to Buyer, transportation and insurance prepaid. Should BioControl’s examination and testing not disclose any defect covered by the foregoing warranty, BioControl shall so advise Buyer and return the equipment in accordance with buyer’s instructions and at Buyer’s sole expense. BioControl warrants its repair work and any replacement parts or equipment for a period of 30 days from receipt by the Buyer of the repaired or replaced equipment or for the remaining balance of the original warranty period set forth in the preceding paragraph, whichever is greater. THE PROVISIONS OF THE FOREGOING LIMITED WARRANTY ARE IN LIEU OF ANY OTHER WARRANTY, WHETHER EXPRESS OR IMPLIED, WRITTEN OR ORAL INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. BIOCONTROL’S LIABILITY ARISING OUT OF THE MANUFACTURE, SALE OR SUPPLYING OF THE EQUIPMENT OR ITS USE OR DISPOSITION, WHETHER BASED UPON WARRANTY, CONTRACT, TORT OR OTHERWISE, SHALL NOT EXCEED THE ACTUAL PURCHASE PRICE PAID BY BUYER FOR THE EQUIPMENT. IN NO EVENT SHALL BIOCONTROL BE LIABLE TO BUYER OR ANY OTHER PERSON OR ENTITY FOR SPECIAL, INCIDENTAL OR CONSEQUENTIAL DAMAGES (INCLUDING, BUT NOT LIMITED TO, LOSS OF PROFITS OR LOSS OF USE DAMAGES) ARISING OUT OF THE MANUFACTURE, SALE OR SUPPLYING OF THE EQUIPMENT. THE FOREGOING WARRANTIES EXTEND TO BUYER ONLY AND SHALL NOT BE APPLICABLE TO ANY OTHER PERSON OR ENTITY INCLUDING, WITHOUT LIMITATION, CUSTOMERS OF BUYER. ...
Appendix E Pipette Verification When neccesary, the following procedure can be used to verify PPMX pipette head performance: Select “Run a protocol” Select R – Standard Low Micro Calibration Verification protocol Enter 8 samples Weigh 2 empty GDS Sample Bases with one sample well strip each and 1 GDS Resuspension Plate prior to start and record weight Load removable tray with disposables according to PPMX Step‐by‐step wizard Enter correct number of missing tips if not using a full rack Vortex Concentration Reagent and remove cap prior to adding bottle to the GDS Reagent Holder Add correct volume of Wash Solution and Resuspension Buffer to reagent reservoir Select “Run protocol” Select “Skip” when asked to simulate Select “Continue” to prompt When run is completed, weigh both filled GDS Sample Bases and the filled GDS Resuspension Plate and record weight NOTE: The protocol will fill the CR and Resuspension Buffer 5x the standard amount, the wash 1x (this is the reason for the different calculations below). Complete the following calculation for the Concentration Reagent & Resuspension Buffer: (FP – DP) / 40 wells = ______________ x 1000 = __________ µL Complete the following calculation for the Wash Solution: (FP – DP) / 8 wells = ______________ x 1000 = __________ µL Dry Plate (DP) Weight of Sample Blocks/Resuspension Plate Concentration Reagent g Wash Solution g RS Plate Resuspension Buffer g Filled Plate (FP) Weight of Sample Blocks/Resuspension Plate Concentration Reagent g Wash Solution g RS Plate Resuspension Buffer g Pipette should deliver 20 ± 1 µL for Concentration Reagent, 1000 ± 20 µL for Wash Solution, and 45 ± 2 µL for Resuspension Buffer. Concentration Reagent __________ µL ...
Deck Layout for R‐Standard Low Micro Calibration Verification 1 Trash bin 1 2 2 Pipette tips (200 µL filter) 3 Reagent reservoir (a Wash, b&c Empty, d RS Buffer) 4 Sample block 1 (1‐48 CR) 6 5 Empty 5 4 6 Sample block 3 (1‐48 Wash) 7 Reagent holder (a Std or b HT CR bottle) 8 RS plate 1 (1‐48 RS Buffer, skipped col.) a b 9 Empty 8 7 *Remove the PickPen Magnetic Head from the arm prior to running this protocol ASSURANCE GDS® PPMX USER MANUAL...
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Appendix F Best Practices If using the R‐protocol + IMS‐protocol format, one removable tray should be for reagent dispensing (Work Zone 1) and the other removable tray for sample preparation (Work Zone 2). The Assurance GDS PickPen Magnetic Head should be removed when running the R‐protocols. Load the 0.2 mL amplification tubes with the hinge to the right (so they open from the left), always load them all the same direction. Always skip columns (should match the resuspension plate). For the 1‐Column Reservoir: During the R‐Wash Solution/R‐Wash Solution Dual Dispense protocols, PPMX switches to the second reservoir for samples 32 to 48 on sample block 5 For the 4‐Column Reservoir, most protocols use the columns as follows: Columns 1 & 2 are for Wash Solution (PPMX uses the first column for up to 48 samples, from sample 49 to 72, the second column is used) Column 3 is for sterile media (BHI or DFB) Column 4 is for Resuspension Buffer Tq Re‐cap Concentration Reagent bottles after each run to prevent evaporative loss and store under refrigeration Cover reservoirs with leftover Wash Solution, Resuspension Buffer and/or sterile media with an adhesive film sheet and store under refrigeration. Notate the date and lot numbers if applicable. Reservoirs with left over Wash and RS Buffer are good for 24 hours. Reservoirs are autoclavable. Always keep the reservoirs filled to the appropriate level for reagents that are aspirated from the top (i.e. Wash Solution and sterile media). Container Type Min Fill Max ...
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Appendix G Pack Up Unplug the Assurance GDS PPMX, place the black power supply in the mini white cardboard box and put into the accessories box. Unplug the control tablet or laptop, place the black USB cable/ferrite cores in their plastic bag and put into the open‐ended accessories box. Place control tablet/laptop and charger back into the labeled computer box and put into the open‐ ended accessories box. Place the control tablet holder (if applicable) in its labeled box and put into the accessories box. Place all the deck accessories into their respective plastic bags and place into the accessories box. Trash bin, tip reload racks, tip puck, reagent holder and power cords (US & EU) in large plastic bag ...
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Install the Alignment Head on the left side of the PPMX arm by securing it to the upper Pipette Head assembly with the thumb nuts. Remove the PickPen Magnetic Head. Wrap the PickPen Head in bubble wrap and place in the accessories box large plastic bag with other deck accessories. Remove the deck tray and set aside, slide the attached metal bottom sheet back so that the rectangular hole aligns with the opening in the base and press the white foam block into the opening to prevent the sheet from moving during shipping. Alignment Head Tape the Alignment Head cable to the foam block. Install the shipping bracket to the arm and inside back of the PPMX by using the allen wrench (5 mm) provided to tighten both screws into place. ...
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Hook the bungee cords together and place under the white foam insert which holds the PPMX unit. Carefully lower the PPMX into the foam insert in the base of the shipping crate, the handholds on opposite ends of the instrument match with the clearance notches in the foam. NOTE: Leave the rotating clear cover down when lifting PPMX to prevent damage from the lid crashing forward. Rotate the clear cover open until it catches on the magnets, using lab tape, secure tbe lower cover to the upper cover. Place the plastic bag over the unit. Attach the bungee cords vertically around the PPMX ...
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Place the two grey foam inserts vertically on the sides of the PPMX for additional protection. Gently lower the crate lid over the PPMX unit being careful not to loosen the grey foam pieces. This step requires 2 people. Attach the 4 bolts to the bottom of the crate using a 9/16” wrench. For Reference: Crate Shipping Size = 36”W x 32” L x 33”H Crate Shipping Weight = 166 lbs ASSURANCE GDS® PPMX USER MANUAL...
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Appendix H Ordering Information ATM kit components: 0.2 mL Amplification Tubes 7 mL Concentration Reagent (2 bottles) Part No. Description 71007‐576ATM GDS for E. coli O157:H7 Tq 71008‐576ATM GDS for Salmonella Tq 71022‐576ATM GDS for Salmonella HET Tq 71009‐576ATM GDS for Listeria spp. Tq The following kits are sold separately but are required for the ATM kit: Wash Solution Part No. Description 61031‐100 GDS Wash Kit (4 x 250 mL) RS Buffer Part No. Description 34724‐100C Assurance GDS Resuspension Buffer Tq (70 mL) 34745‐100C Assurance GDS Listeria Resuspension Buffer Tq (70 mL) If running a single wash protocol the ratio is 2 ATM kits to 1 Wash and RSB kit [2:1] ...
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