GenMark Dx ePlex User Manual

GNMK-IMC-6072-A
Inspection and Installation Qualification
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)

GenMark Dx ePlex Specifications

General

Brand	GenMark Dx
Model	ePlex
Category	Tools
Language	English

Summary

OS Image Installation

USB Drive Preparation

Inserting the bootable USB drive with the Acronis image file into the system.

BIOS Setup and Boot Order

Entering BIOS setup and configuring the boot order to the USB drive.

Acronis True Image Operations

Performing disk and partition recovery using Acronis True Image software.

Tower Installation

Tower Inspection and Panel Removal

Inspecting the Tower for damage and removing structural panels.

PCB Slider and Shock Inspection

Inspecting PCB sliders and shocks for damage or proper seating.

Bay Slot Configuration

Cable Routing and Connections

System Leveling

Tower Leveling Procedure

Using a dual axis digital level to level each Tower independently.

Repeat Leveling for Additional Towers

Bay Installation

Bay Inspection and Preparation

High-Density Connector Check

Bay Insertion and Securing

Bay Dip Switch Configuration

Configure OS Settings

Network Configuration

Configuring IP address and subnet mask for network connectivity.

Computer Name Change

Changing the computer name to follow the defined naming convention.

Configure ePlex Settings

General Settings

Selecting language, enabling manual entry, and configuring remote access.

Reports Settings

Tailoring reports with lab information, printer preferences, and logos.

LIS Connection Settings

Enabling connection to the customer's Laboratory Information System (LIS).

User Account Setup

Setting up an initial Supervisor account for customer user management.

Bay Leveling Procedure during OQ

Test Cartridge Preparation

Dual Axis Level Accuracy Check

Fine Tuning Bay Level

Operational Qualification (OQ)

DXL360S Dual Axis Inclinometer Calibration