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GenMark Dx ePlex Inspection And Installation Qualification

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PURPOSE
The purpose of this document is to establish standardized procedures for the inspection and installation of the
ePlex system at customer sites.
SCOPE
The procedure described in this document only applies to ePlex systems and should be performed during initial
installations at customer sites. This procedure also applies to the addition of Tower(s) to previously installed
systems.
DEFINITIONS
• Inspection and Installation Qualification (IIQ) – Inspection and qualification of hardware
components performed during assembly and configuration of the ePlex system. Performed prior to
Operational Qualification.
• Operational Qualification (OQ) – Tests performed on the ePlex system after IIQ to ensure proper
and safe operation. Performed prior to release of system to customers for use.
• Password of The Day (POD) – Randomly-generated daily password valid for that date only.
Required to login to the ePlex instrument using the "Internal" account.
• Assay Definition File (ADF) – Assay-specific software protocol that defines various assay
parameters for the ePlex system to process samples on ePlex cartridges.
PROCEDURE
Note:
Generate the POD prior to proceeding with Base installation.
Base Installation
Decontaminate the area where the ePlex system will be installed with 10% bleach or similar solution
(location defined in the QF3346 ePlex Pre-Installation Checklist).
Check the packing slip for the line containing the Base serial number for confirmation of shipment.
Inspect all shipping boxes and check for visual damage during transport.
Verify that the serial numbers for base, tower(s) and bays match the serial numbers on the packing
slip.
Verify the startup kit box contains:
• Barcode scanner
• Barcode scanner mount
• 8" bolts (qty. 6)
• 15" bolts (qty. 6)
GNMK-IMC-6072-A
Inspection and Installation Qualification

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Summary of Contents for GenMark Dx ePlex

  • Page 1 SCOPE The procedure described in this document only applies to ePlex systems and should be performed during initial installations at customer sites. This procedure also applies to the addition of Tower(s) to previously installed systems.
  • Page 2 • Lock washers • Grounding nuts Note: Keep bolts and any unused side panels at customer site for future Tower add-ons Remove the Base and Power Cord (US Nema 5-15P) from the shipping box and examine for signs of physical damage. For damaged items, request an RMA from Technical Support at: technicalsupport.eu@genmarkdx.com, providing a description of the damage.
  • Page 3 Notice the parallelism of the bolt to the bench, this will cause attachment issues. Figure 1 Example of misaligned mounting hole If the mounting holes are not properly aligned, call CTS for instructions. Check all cable connections on the motherboard, back of touchscreen and hard drive inside the base to ensure they are secure after shipping by gently pressing on each connection.
  • Page 4 Insert the bootable USB (flash) drive with the Acronis image file into an ePlex USB port. Power on the ePlex system and press and HOLD the Delete key on the keyboard to enter the BIOS setup. Type the BIOS password if one has been preset. Otherwise, leave the password box blank and click the Enter key.

  • Page 5: Tower Installation

    Use the LEFT/RIGHT arrow keys on the keyboard to navigate to the Boot tab. Use the UP/DOWN arrow keys on the keyboard to navigate to Boot Option #1 under FIXED BOOT ORDER Priorities then hit Enter. Use the UP/DOWN arrow keys to navigate to Hard Disk (INTEL SDD...). Press Enter then F4 to save these settings.
  • Page 6 If configuration is an NP, please continue to refer to the 3 Bay (NP) installation instructions to set PCBA slider positions. Locate the ePlex bay slots in the tower, these will be referred to as numbers 1 – 6 from top to bottom (see Figure 5 for reference).
  • Page 7 Figure 5 Bay slot positions To allow the ISW to properly connect, the switch positions on the slider PCBA’s within the tower positions need to be changed. Refer to Figure 7 for the NP Tower switch configuration. Using a switch tool or similar, change the switch configuration of PCBA position 3 and PCBA position 5 to match Figure 7.
  • Page 8 Bottom out the front Tower feet on the bottom of the tower. Position Tower(s) on the work bench next to the Base using one of the available positioning options for ePlex Base-Tower configuration shown in Figure 8. Configuration should be based on number of towers, space available, and customer preference.
  • Page 9 Figure 8 ePlex Tower Configurations Cut the zip ties around the cables, route and connect the following. • Power cable(s) to Base Power Distribution Board • Grounding cable(s) from Tower grounding bolt(s) to Base grounding bolt(s). • Ethernet cable(s) to Base Ethernet Switch If installing a four (4) Tower system, or a two (2) Tower system with both towers on the right-hand side, Tower position D’s power cable needs to have added strain relief.
  • Page 10 Figure 10 Power and Ethernet Cable Figure 11 Connecting Base and Towers Note: There are two grounding bolts mounted horizontally to the roof of the Base, one on each side. Each Tower has one grounding bolt mounted on its rear side. Grounding cables should be routed directly from each Tower to the Base.
  • Page 11 Figure 12 Current Power Connector w/o tie wrap on position 4(D) Thread a six-inch (6”) cable tie between the positive and negative wires of Tower D’s power cable. (Figure 13) Figure 13 Cable tie on power connector Connect the power connector to the mating receptacle on the power distribution board and thread the cable tie through the metal leads of the connector that is soldered to the power distribution board.
  • Page 12 Ensure both ends of each wire or cable are firmly in place. Install and secure the structural panels to Base and Tower(s). (This should be done prior to attaching the cabling/wiring due to risk of pulling and damaging the connections) Attached the 3 bolts to connect the Tower(s) to the Base using the appropriate bolt (M10) and fasten and secure the Tower(s) to the Base with an 8mm torque wrench set to 2.0 N⋅m or 15.0 lb⋅in.
  • Page 13 Figure 16 Acceptable Leveling Range from −00.25° to +00.70° (X-axis, left potentially high) and 0° to -00.70° (Y-axis, back high) Repeat steps 4.1 - 4.2 for additional towers as needed. Bay Installation Check the shipper to ensure the correct number of Bays have been delivered. Note: If spare bays were shipped or trunk stock bays are available, DO NOT use unless any of the primary shipped bays are OOBF.
  • Page 14 Figure 17 Bay Lead Screw Nuts Clean the inside of each bay using compressed air. Check all bays for debris and ‘chads’ inside the bay. Remove if found. Figure 18 Label ‘chad’ stuck on top of bay Check the high-density (HD) connector on each Bay to ensure they are seated properly. Press down on both sides to tighten if necessary.
  • Page 15 Figure 19 Clean Bay (1) and Check High Density Connector (2) Notice the spacing Notice the spacing difference difference Ensure the rear HD Ensure the rear HD connector is fully seated connector is fully seated Figure 20 Tilted and disconnected HD connector board Inspect gaskets for debris and clean the rubber gaskets, use a long swab and Isopropyl alcohol or Ethanol to carefully clean the top surface of the black rubber gasket...
  • Page 16 Notice the gap between the tubing and valve body, and the Correct assembly radial bend of the tubing Figure 22 Tubing assembly routing If the tubing is assembled incorrectly, reseat the tubing, ensuring the tube face is flush against the valve wall, and the service loop in the tubing is roughly parallel to the main PCBA.
  • Page 17 Figure 23 Bay Dip Switch Location T o w er P o s itio n D ip s w itc h P o s itio n Figure 24 Bay Dip Switch Settings Plug in the main power cord to the Base and flip the rear power switch to the ON/up/”I” position. Power up the system by turning on the rear power switch and pressing the Base front power button.
  • Page 18 If you do not see the pink light, take the Bay out and wait 3 minutes before placing it back in the system. Figure 25 Bay Power & Communication Indicator LED (3) Ensure all Bays installed have connected to the system, as indicated by flashing red LEDs. Note: If Bays are not connected, the LEDs at the front of the Bay will not flash red and the status in the Bay Configuration tab will indicate they cannot connect to the system.
  • Page 19 Figure 26 IP Configuration Setting Select the Start icon then navigate to Computer and right click, select Properties Figure 27 System properties Select Change Settings to open System Properties. GNMK-IMC-6072-A...
  • Page 20 Figure 28 Change System Settings Under the Computer Name tab, click Change to open the Computer Name/Domain Changes window. Figure 29 Computer Name Change the computer name as defined in the naming convention below. • Default Computer Name: ePlex00000 • New Computer Name: i.e. ePlex1640100124 (must be changed to the 10-digit Base serial number) GNMK-IMC-6072-A...
  • Page 21 Figure 30 ePlex Computer Name Change A notification window will appear as a reminder that the ePlex instrument must be restarted before the changes can take effect. Click OK. Figure 31 System Restart Click Close in the System Properties window.
  • Page 22 Insert any USB flash drive and select the option Save the recovery key to a USB flash drive then select the USB drive and select Save. (DO NOT USE THE S/W IMAGE USB DRIVE) Figure 33 Storing a Recovery Key When successfully saved, you will notice the message Your recovery key has been saved then locate the file in USB flash drive with the name BitLocker Recovery Key xxxx.
  • Page 23 Bit Locker Recovery Key.xlsx in addition to the appropriate instrument serial number for any necessary hard-drive access in the future. Barcode Scanner Update Plug in barcode scanner to USB port on the ePlex instrument or a Win7 laptop with Jadak ImageView Open Jadak ImageView SW GNMK-IMC-6072-A...
  • Page 24 Figure 35 Jadak ImageView Press Connect Press Get Version Confirm returned version is #FW-MH3301-03-A5 or less Press Load FW GNMK-IMC-6072-A...
  • Page 25 Note: Scanner should beep and the red LED should turn on shortly after firmware flash completed. Press Close Remove the scanner USB cord from the ePlex instrument and wait 5 seconds Insert scanner USB cord scanner back into the ePlex instrument...
  • Page 26 Note: Scanner will make a beeping noise to confirm it read the barcode Press Close Close Image View SW Remove the scanner USB cord from the ePlex instrument and wait 5 seconds Insert scanner USB cord scanner back into the ePlex instrument Open ePlex ISW Login to ePlex software using the Internal POD.
  • Page 27 • Add the Tower SN to the text box Select Apply For all other configurations add towers to the ePlex instrument by selecting the Add Tower button and enter the Tower serial number(s). See Figure 37 below. Figure 37 Adding Towers in ISW Verify the ePlex fans (CPU and Chassis) inside the Base are operational.
  • Page 28 Go to the Run screen and test the timeout by covering one of the barcodes (accession ID or QR code) and scanning an ePlex cartridge. The red crosshairs should turn off after 2 secs instead of 9.9 sec. Test a customer accession ID barcode on an ePlex cartridge to ensure customer barcode scans properly.
  • Page 29 Click Select to install OQ library. Assay Definition File Installation Plug in the USB drive to the ePlex instrument and navigate to Settings > Assays. See Figure 38 below for reference. Select the Import button and navigate to the ADF file to be installed.
  • Page 30 Install GLI Open command prompt by typing cmd on Run task Figure 39 Run Command While in command prompt, type sadmin bu to enable McAfee. Password is Genmark5964. Verify that McAfee Solidifier is entering update mode Figure 40 Command Prompt Uninstall current GLI by going to Start >...
  • Page 31 Figure 41 Windows Services Search for Window Update, double click on the task Figure 42 Windows Update Service Change Startup Type from Disable to Manual > select Apply > select Start button to start the service. GNMK-IMC-6072-A...
  • Page 32 Figure 43 Windows Update Properties Verify that the service is updated to Started Figure 44 Windows Update Started Locate the latest MS Patch installation package. Figure 45 Example of MS Patch Update File GNMK-IMC-6072-A...
  • Page 33 Double click on the Patch installation file to start the installation process and follow instructions. Figure 46 MS Patch Installer Figure 47 Installer Status GNMK-IMC-6072-A...
  • Page 34 Figure 48 Installation Complete Click on the Close button to finish the installation process. Restart the system, log back to the ePlex system with GNMK Service user Go to Control Panel > Administrative Tools and double click on Services Change Window Update back to Disable.
  • Page 35 Figure 50 Installed Updates Open the command prompt by typing cmd into the run box. Type sadmin eu to exit McAfee update mode. Password is Genmark5964. Verify that McAfee Solidifier is exiting from update mode Figure 51 Exit McAfee Update Mode Reinsert the network Ethernet cable if unplugged during step Remote Access Client Installation (Optional).
  • Page 36 Go to settings > General tab> click the check box “Allow Remote Access”, then click Apply. Printer Setup (Optional) Note: For a network printer to be connected to the ePlex system, there must be an Upgrade Printer package file (if the printer is supplied by GenMark) or a Network Printer Name from the customer.
  • Page 37 Figure 53 Add Printer in ISW Select Local Printer or Network Printer, based on customer preference. Use the Browse button to navigate to the printer package on the USB drive. For a Network Printer, Enter the Printer Display Name and the Printer Network address (i.e. Hqprn21 or 192.168.2.40).
  • Page 38 If the customer chooses to utilize Remote Access (where applicable), check the box to Allow Remote Access. An icon for BOMGAR should appear at the bottom of the screen. If a UPS is connected to the ePlex instrument, check the box for UPS connected under Settings > Reports The customer has the option to tailor their reports to reflect their laboratory information and preferences.
  • Page 39 Test Email button to verify that the email has been successfully set up. Ensure that the Network Drives requested by the customer have been added into the ePlex system and are connected. Connection can be tested by exporting a file to the mapped drive and confirming its arrival to the appropriate location.
  • Page 40 Figure 55 Parafilm placement on cartridge secured with small pieces of clear tape Start an ePlex instrument run using the keyboard icon and typing “para” and press Enter If EEPROM information entry is required, select RP and enter any other inputs as needed (i.e. 123)
  • Page 41 Preflight will start and eventually fail after pogo pins have pressed against the parafilm. Repeat steps 21.3 - for each bay. Inspect inside of all bays to ensure no parafilm or tape was left behind inside the bay and all gaskets have not been dislodged.
  • Page 42 Figure 58 Fine Tuning Bay Leveling Unlock the ¼ turn bay fasteners and use slight pressure to fine tune level on all bays Using a dual axis leveling device note the initial measurement in both axis and record the data below. Level the system in X axis (-0.25°...
  • Page 43 Figure 60 Dual axis bubble ideal and acceptable range in the upper left quadrant Note: Only minor adjustments can be made with this procedure. GNMK-IMC-6072-A...
  • Page 44 Ensure towers are in same plane and all but the out 4 feet are raised up off the bench so they don’t bottom out when trying to level the outermost feet. Record the level information in the ePlex Level Template spreadsheet. ePlex Level Template.xlsx...
  • Page 45 Extend all floating feet on Base and Tower down to the bench and turn 1/8 rotation to stabilize the feet on the bench. Install and secure the cosmetic side panels to the outer right and left sides of the ePlex system and mount barcode scanner.
  • Page 46 STEP 3: LCD display ‘CALIBRATE HORIZONTAL PRESS SET’. Place the unit horizontal like the picture STEP 3 and then press SET, wait until the beep sound stop. STEP 4: Then rotate the unit 180° on same plane at the same place. Press the SET button again and wait for the beeping to finish.