Table of Contents
Advertisement
Compliance and Safety
Additional training and assay evaluation will be required for any additional assays that
are subsequently cleared on the Panther System.
Read this manual before using the Panther System. Upon completion of training, keep
this manual available for reference.
Compliance
Electromagnetic Compatibility
The Panther System has been tested according to the following directives.
IEC 61326-2-6:2012 Electrical equipment for measurement, control, and
l
laboratory use—EMC requirements Part 2-6: Particular requirement—In vitro
Diagnostic (IVD) medical equipment.
Safety
Follow standard laboratory precautions when operating the Panther System. The
warnings in this section apply specifically to the Panther System and its related
components.
Hologic does not take any responsibility for unauthorized modifications of the
instrument or for failure of operating personnel to heed the warnings and cautions.
Any equipment used in a manner not specified by Hologic, Inc., may become unsafe.
Review all the warnings in this section before operating the Panther System.
Panther System Warnings
Warning—The following warnings apply to general use of the
Panther System. Additional warnings are listed throughout the
manual.
System Handling Warnings
The Panther System must be installed and qualified by Hologic authorized
l
personnel.
Do not modify the Panther System hardware or software without written
l
authorization from Hologic. Do not add accessories, or use supplies not
authorized by Hologic.
Except for the maintenance instructions specifically articulated in this
l
manual, do not attempt to service the Panther System. Repairs should be
performed by qualified authorized personnel only.
®
Panther System
Operator's Manual
AW-17791-001 Rev. 002 (EN)
Compliance and Safety
6
Advertisement
Table of Contents
