Rotor-Gene Q MDx CE User Manual 02/2022
10
1.2.3
Version management
This document is the
Rotor-Gene Q MDx User Manual
, revision R1, for Rotor-Gene Q MDx
instruments using Rotor-Gene Q software version 2.3.x (where x is ≥ 0).
1.3
Intended use of the Rotor-Gene Q MDx
The Rotor-Gene Q MDx instrument is designed to perform real-time thermal cycling, detection,
and/or quantification using the polymerase chain reaction (PCR) in clinical applications.
The Rotor-Gene Q MDx is intended to be used only in combination with QIAGEN kits indicated for
use with Rotor-Gene Q instruments for applications described in the respective QIAGEN kit
handbooks.
If the Rotor-Gene Q MDx instrument is used with other than QIAGEN kits, it is the user’s
responsibility to validate the performance of such product combination for any particular
application.
The Rotor-Gene Q MDx instrument is intended for in vitro diagnostic use.
The Rotor-Gene Q MDx instrument is intended for use by professional users, such as technicians
and physicians trained in molecular biological techniques and the operation of the Rotor-Gene Q
MDx instrument.
1.3.1
Requirements for Rotor-Gene Q MDx
The table below covers the general level of competence and expertise necessary for transportation,
installation, use, maintenance and servicing of the Rotor-Gene Q MDx.
Task
Personnel
Training and experience
Delivery
No special requirements
No special requirements
Installation
Laboratory technicians or
equivalent
Appropriately trained and experienced personnel
familiar with the use of computers and automation in
general
Routine use (running
protocols)
Laboratory technicians or
equivalent
Professional users, such as technicians or physicians,
trained in molecular biology techniques
Routine maintenance
Laboratory technicians or
equivalent
Professional users, such as technicians or physicians,
trained in molecular biology techniques
Servicing and annual
maintenance
QIAGEN Field Service specialists
only
Regularly trained, certified, and authorized by
QIAGEN
