Fusion System Overview

Panther Fusion System General Overview

The Panther Fusion® Module (also referred to in this manual as the Fusion Module or the Fusion Sidecar) is an optional feature to the Panther® System. The Fusion Module is attached to the left side of the Panther System to expand the overall system capabilities. Together, the Panther System with the Fusion Module is referred to as the Panther Fusion® System.

The Panther Fusion System is a dual format molecular diagnostic system designed to run Hologic target-amplified assays, utilizing Chemiluminescence and Fluorescence detection technologies for both qualitative and real time assays. It runs 275 AptimaClosedAutomated Probe Transcription Mediated Amplification. Trade name for amplified NAT infectious disease assays and reagents designed for use with Hologic's instrument platforms.® reactions in a single shift, and has the capacity for 500 to 600 reactions before requiring waste removal. With the Fusion Module upgrade, PCR assays can be run (intermixed) and achieve similar throughput.

The Fusion consists of a thermocycler with real time fluorescence detection, a PCR Card Bay that allows for loading new PCR reagent cards, additional tip trays, and a pipettor system to perform the assay steps needed for the PCR reaction.

ClosedPanther Fusion System Device Description

The Panther Fusion System consists of the instrumentation and computer together in a single unit. The system is operated via the touch-screen monitor that is connected to the system. Communication with the system is controlled through a number of processing boards known as the Communication and Organization Processor (COP). The COP is used to direct the operation of the subsystems to perform the assay steps, as well as accommodating LIS connectivity and remote user access.

The Panther Fusion System is composed of four main areas:

ClosedCustomer Confidentiality

It is our policy to ensure the confidentiality of our customer’s information. Service personnel should not use any customer information for any purpose other than providing customer service or disclose such information to third parties. In particular, service personnel who access customer equipment, either directly or through remote tools, should ensure they are not provided access to personally identifiable medical or health information. Such information may include information held by a customer that concerns health status, provision of health care, or payment for health care which can be linked to an individual. If, in the course of providing customer service, service personnel inadvertently view or access any personally identifiable medical or health information, service personnel should treat such information as strictly confidential and should not disclose such information to any third party or use such information for any purpose. We advise customers to use industry best practices regarding patient health information and do not recommend sending patient identifying information to instrumentation.