Dynex DS2 Inspection and Installation

Qualification

Purpose
The purpose of this document is to establish standardized procedures for the inspection and installation of the
Dynex DS2 system at customer sites.

Note: The DS2 Operator’s Manual contains detailed instructions for the DS2 setup. The manual is packed in the DS2
Accessory Box. Dynex recommends consulting this manual while setting up the DS2 System.
Also available is the DS2 Service Manual, which is available electronically.

Procedure
The DS2 Inspection and Installation Qualification procedure should be followed in conjunction with the completion
“DS2 Installation Checklist” provided.

Note: Fill out the customer and system information section of the “DS2 Installation Checklist” prior to proceeding
with the installation.
A copy of this record should be made and left with the instrument after installation
Required Items
One 96-well plate (Not provided; should be typical microplate used in the majority of kits, preferably with flat
bottom) => bring a 96 well plate
Arm Calibration Fixture, collar, hex wrenches (Provided with the instrument)
Set of samples tubes with barcodes (minimum 10)
Dynex Control Bottles (2)
Dynex Reagent Bottles (2 Large 25mL)
Dynex Sample Tips
Dynex Reagent Tips
1 Deep Well Dilution Strip
Distilled or Deionized Water
Plastic bottle or carboy for Clean Solution C (500-1000mL capacity)

Uncrate and Inspect the shipment

o Check the packing list and compare it with the delivery report to see if all boxes were delivered on site.
o Inspect shipping box and check for visual damages during transport. Note any damage and report it to QIAGEN.
o Carefully Open the cardboard lid.
o Remove the 4 wooden corner supports inside the crate, as well as foam pieces.
o Remove the DS2 Accessory Box.
o Squeeze and remove the 8 plastic clips along the bottom of the crate to release the remaining cardboard shell
from the pallet.
o Lift and remove the cardboard shell.

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 o Clean the area where the DS2 unit will be installed.
o Remove the DS2 from the shipping box and put it on the bench and examine for signs of physical damage. - Note
any damage and inform QIAGEN
o The DS2 system is heavy and most of the weight is in the rear of the system; please use at least 2 people to lift
the DS2 from the pallet to its desired location.
o Note the DS2 serial number on the “DS2 Installation Checklist”
o Verify that DS2 Accessory Box contains items listed in the “DS2 Configuration Report” included with every DS2.
o Remove all ties and shipping brackets from the workspace. Don’t forget the bracket holding the pipette module
to the rear wall of the DS2.

Use the DS2 internal shipping Brackets

and foam Removal Instructions.

o Store all ties and brackets in a safe place for reuse should the instrument need to be moved or shipped.
o Allow the instrument to come to room temperature.
o Setup the DS2 workspace:
Insert the sample and reagent racks into their designated slots.
Load the Sample and Reagent Tips into their correct positions.

Note: Please remove the cover of box and the blue bottom of the box.
Unwrap the wash-head and attach it to the tubing + place the tray under the wash-head.
Rinse and load wash buffer bottles with ~500ml of distilled water.
Verify that buffer bottles and waste bottles are connected correctly.
Connect Bottle C (Plastic bottle or carboy) to the rear of the DS2 and fill it with distilled/deionized water.

Note: Please ask the customer a container with distilled water and connect with the elbow fitting.
Computer Setup
o Connect the computer components and power cords (need 4 electrics sockets: 1 PC; 1 SCREEN; 1 instrument;1
printer).
o Power on the CPU and verify that it opens to Windows®7.
o Ask to the customer to select a password.
o Power on the CPU and verify that it opens to Windows®7.
o Install the DS-Matrix Setup Prerequisites (CD provided with the system)
o Install DYNEX Database Installer (CD provided with the system)
o Install the DS-Matrix Software (CD provided with the system)
o Install the DS2 Toolbox Software (CD provided with the system)
o The installer will put an application titled "DS2 Toolbox" in the DS-Matrix folder.
o Install the LIS-Link Software if necessary (only needed for LIS connectivity)
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 o Make sure that all users have permissions to write in the folder “Dynex Technologies” under C drive with the
following procedure:
Open file explorer
Go to C:\Program Files(x86) and select the folder “Dynex Technologies”
Right click on it and select properties
Go to Security tab and change the permissions for all Users by allowing them All by clicking Edit after
selecting a User. ( Note: + click EDIT+ click on all).
o Connect the computer to the DS2 using a USB cable ref 50600167 to connect to the USB port on the DS2
o Connect the power cord to the DS2 and plug the cord into the power source. (It is highly recommended to use
a UPS system for the DS2 and associated CPU).
o Plug the Dongle for Multitube support (provided in the accessory box) in an available USB port.
o Power on the DS2. Windows may indicate that it has detected a new USB Device.

Change Power Saving Settings

o On the DS2 computer, open the Control Panel and go to Hardware and sound/ “Power Options”/edit plan
setting/turn off never/put the computer to sleep never..
o Ensure the system is set to never hibernate or enter standby.

Change Deep Well Dilution Strip Submersion Depth to 5mm (ONLY FOR PRE-5.00 Assays)
o Right click on the DS-Matrix icon in the start menu, and go to “Properties”.
o At the end of the “Target” string, add /eng ( keep a space between add and/). This will allow you to enter
engineering mode for DS-Matrix.
o Open DS-Matrix in simulation mode and close the self test windows.
o Go to “Database Maintenance” found under the “Tools Menu”.
o Open the properties for the “Dynex Deep Well Strip” and change the tip submersion depth to 5mm.
o Be sure to save and verify the 5mm remains.
o Exit DS-Matrix, return to the DS-Matrix icon properties and remove the /eng

Change Dispense Height Settings

o The default dispense height setting is too low and could lead to cross contamination of wells in some assays.
o Change the ‘default dispense height’ by opening the configuration file in notepad.
o The configuration file is found using the following pathway: Program Files(x86)/Dynex Technologies/DS-
Matrix/MatrixApp.exe.config
o Right click on MatrixApp.exe.config and choose the “Open” option.
o Select to open the file with Notepad.
o Scroll down through the configuration file until the setting for “MPDispenseHeightMM” comes into view.
o Change the value for this setting from 3.0 to 5.0.
o Save the configuration file, ensuring that the original ‘.exe.config’ extension is not changed.
o You will need to do “Save as” to save the modified file in another location (e.g. desktop);
o Then delete the original file MatrixApp.exe.config in Program Files/Dynex Technologies/DS-
Matrix/MatrixApp.exe.config and after that paste in the same folder the file saved on the desktop.

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System Configuration: select the simulation mode
o Ensure the DS-Matrix software is running. From the Tools menu, select “System Configuration”:
o In the tab “Fluids” check the box “Dynamic Fluid Tracking…”
o In the tab “Operations” check the boxes “Enable Boolean Function Assays”, “Debug log”
o In the tab “Data Read Limits” change the Over setting to 3.00. Check the box Over/Under Conversion and leave
the values to 9.999 and -9.999
o Setup monthly database backups on the “Database Backup options” tab => Sample and => setup instrument
o Click the OK button to save the change.

Self-Tests
o Switch on: first instrument and then the PC
o Ensure the DS2 is powered on and the Lid is closed.
o Open the DS-Matrix Software. If the DS2 is operating correctly and the software is installed correctly, the PC and
the DS2 will “connect” and a Self-Test Procedure that takes ~2-3 minutes will commence.
o The arm will move unpredictably during this time, so observe safety precautions and do not reach into the
workspace.
o If a startup error occurs, an onscreen notification will appear.
o About half-way through the Self-Test Procedure, a Self-Test Report will open on the screen.
o This first self-test report should be printed out and attached to the installation checklist.
o In order for the Self-Test to continue to completion, it is necessary to close this screen by clicking on the Red X
in the upper right corner of the window.

Check Absorbance Filter Settings

o From the Tools Menu, select Absorbance Filter.
o The DS2 ships with a standard set of filters – 405, 450, 490, & 620.
o If DS-Matrix is not already set to these defaults, enter the wavelengths into the respective fields.
o The #1 position should always be set to 405 nm.
o Note, you cannot make changes to the filter information in “Simulation” mode, You must be connected to the
DS2.

Check Wash Tubing and Pinch Valves

Please see the “DS2 Pinch Valve Tubing Instruction”

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 o Remove the Waste Tip Container. Behind it, on the vertical plate, you will see three large pinch valves and one
small pinch valve.
o On new units from the factory, the tubing manifold is not set in the pinch valves.
o An instruction sheet packaged with the new instruments has a diagram and instructions for putting the tubes in
the pinch valves.
o Carefully place the tubes fully into the pinch valves if they are not already positioned in the valves.

Note: If the instrument is not used regularly or arrived with these tubes already installed, these tubes can be sealed
shut resulting in inadequate wash fluid dispensing. Gently pull the tubing out from each pinch valve and roll it
between your thumb and forefinger to break any seals. Also, verify that the feed tubes from the wash bottles are not
kinked or bent in such a way that flow to the wash head is blocked or impaired. The connector for the clean water
supply should be attached to the port on the rear of the DS2 and the tubing placed into a bottle filled with 500-
1000mL of DI water.
Installation Assay
Note: Please use the USB KEY with protocol assay. Go to TOOL/IMPORT/Export/Assay Protocol/Installation assay.
o Import the assay software “Installation Assay.xml” provided by Dynex.
o The purpose of this assay is to ensure proper functioning of the modules on the DS2. Items to evaluate during
each assay operation are listed in these instructions
o Import the following assays, provided by Dynex, using the Import/Export function:

 End of Day Assay.xml

 Start of Day Assay.xml
 Washer Rinse.xml
 Import the latest QFT Assay Software
 QFT assay

Note: If the plate you will be using for this assay is not a flat bottom microplate, enter the template for the assay and
change the microplate type being used. Change the sweep mode in the wash operation to “none”.

Barcode Scanner Test

o Prepare 10 hemolysis tubes

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o Create a new sample batch using the worklist editor.
o Enter 100 as the number of samples. Place the sample tubes with barcodes sporadically throughout the 5 sample
racks.
o Load the samples when prompted by the system and read the barcodes.
o Verify that the correct barcode information is scanned for each of the barcoded sample tubes present in the
racks.

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 Run the Installation Assay
o Before perform a washprime.
o Create a new worklist with a minimum of 10 samples.
o Select to barcode scan the sample IDs.
o Add the “Installation Assay” provided by Dynex to the worklist. (double click to select the protocol).
o Click “accept”.
o As the assay is running, observe the following:

Pipetting Test
The assay will begin by performing a dilution of the standard and the control. The dilutions should be observed
carefully to verify that the pipetting behavior is correct. Two deep wells should be used. 500ul of Sample Diluent
should be transferred from the large reagent tube into the deep wells using a reagent tip. 50ul of each standard and
control should be transferred from the designated vial using a sample tip. 2 mixing cycles should take place, and
50ul of the diluted control and standard will be pipetted into the plate. The System will then pipette 50ul of sample
into the plate using sample tips. The spigot should pick up all sample tips with no problems. The spigot should be
centered over the tips. There should be no splashing. The tip should be centered over the deep wells and microplate
wells. The aspirate should be clean with no air bubbles. The air gap pulled when dispensing to the wells should be
clean and uniform. The pipette tip should be observed when it goes to aspirate fluid from the reagent bottle. The
tips should descend to a tip submersion depth prior to the aspiration of fluid. The aspiration should be clean and
smooth with no bubbles or air gaps. During the subsequent dispenses, the tip should descend to the same depth of
the first dispense. Visual observation of the plate should indicate uniform fluid levels in the wells. Tips should be
ejected from the spigot in random locations over the tip eject area. Tips should not be consistently ejected in the
same location

Dispensing Test
After pipetting is complete a dispense operation will be performed. Ensure that as the fluid is being dispensed into
the plate wells, that the tip is centered and that it is not dispensing fluid directly into the sample and creating
bubbles. The tip should dispense just above the sample. There should be no splashing and few (if any) air bubbles.
When the pipette moves from well to well during the dispense operation, it draws in an air gap. Check the air gap in
the tip and ensure it is clean and that fluid contained in the well is not being aspirated back into the pipette tip.

Incubation Test
The next test is an incubation test. Ensure that the plate moves smoothly into the incubation chamber and shakes
for approximately five seconds. Ensure that the spigot contacts the door switch at the rear of the chamber and fully
opens and closes the incubator door. The plate should move out of the incubation chamber at the end of the one
minute incubation. There should be no unexpected banging or rattling noises.

Washer Test
The washer will perform one purge cycle, three wash cycles, and 1 clean cycle. During the purge cycle, ensure that
fluid is moving freely through the washer head tubing lines. There should be no unusual sounds. The washer will
then perform three wash cycles. During each cycle ensure that there is no overflowing, that the wells are close to
full with wash buffer prior to aspiration, and that the aspirate pins are perfectly centered in the wells. If you are
using a flat bottom microplate, at the end of the three cycles there will be a super sweep aspiration and the
aspiration pins will lift up and move in an “X” pattern across the well. There should be no contact between the plate
and the pins as they move across the well. There should be no usual scratching sounds. Following the wash cycle,
fluid should be drawn from the clean bottle to clean the wash head. If any unusual sounds are heard during any
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wash operation steps or fluid is not dispensed, remove the tubing lines from the pinch clamps behind the waste
container and roll them in between your fingers to ensure they have not sealed shut.

Reader Test
Following the washer test, the plate will enter the reader chamber to be read. There should not be any grinding,
banging or rattling noises and the plate should move smoothly in and out of the chamber.

Following the Installation Assay

Remove the plate from the plate carrier and inspect the wells. Ensure that the wells do not contain liquid pools.
The wells should contain only minute specs of water, if they contain any liquid at all. Inspect the well bottoms by
holding the plate up to the light. There should be no visible scratches on the bottom of the plate. If the wells
contain excessive amounts of liquid or if there are scratches on the bottom of the plate, an arm calibration
procedure should be performed. If the calibration does not resolve the problem, it is possible that a custom plate
definition must be created in the plate database.

Uncharacteristic Noises and Sounds

During initial operation, the installer should make a note of any noises or sounds that seem abnormal. These can be
noted on the checklist.

Perform the Arm Calibration Procedure within the DS2 Tool Box (if required)
The arm is calibrated as part of the instrument setup and QC/QA operations at the factory. In most instances, the
calibration will be maintained during shipping, and will not be required at installation. If, however, initial testing
indicates calibration issues, the procedure should be performed during installation.
This procedure calibrates the arm to a number of points on the workspace of the DS2. This procedure should be
performed carefully and accurately. Calibration coordinates generated during this procedure will be stored in
memory.

Possible signs that indicate a spatial calibration issue:

o Pipette banging into tips when picking them up.
o Dispensing and pipetting near the edges of wells.
o Inability to pick up the wash head.
o The wash head dispensing out of the wells.
o Tips hitting the bottoms of tubes or bottles.
o Aspirate pins not centering in wells during wash.
o Wash buffer dispensed at edge of the wells.
o Scratching of plate during wash.
o Excess fluid remaining after wash.
o Tips banging into the workspace instead of being ejected.
o Tips not being picked up or falling off in transit.

This procedure have to be taught to referent users of the DS2.

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