BD PrepMate Automated Accessory - 1 Introduction; Intended Use; Requirements

5
1 Introduction
1.1 Intended Use
The BD PrepMate™ Automated Accessory is an accessory to the BD SurePath™ Liquid-based
Pap Test, the BD PrepStain™ Slide Processor and the BD Totalys™ SlidePrep. The BD
PrepMate
™ Automated Accessory automates the initial enrichment process of mixing and
dispensing the specimen over BD Density Reagent.
The BD PrepMate
™ Automated Accessory mixes and removes the specimen from a
BD SurePath™ Collection Vial or BD CytoRich™ Clear Vial. It then layers the specimen onto
the density reagent in a centrifuge tube. The automated process handles from one to twelve
specimens per cycle.
1.2 Requirements
• Gynecologic specimens for preparation using the BD PrepMate™ Automated Accessory
should be collected using an approved sampling device according to the standard collection
procedure provided by the manufacturer.
• Training by authorized personnel is a prerequisite fo
r production of BD SurePath™ and BD
CytoRich™ slides. Intended users are trained cytology laboratory personnel operating under
the direct supervision of a qualified cytology supervisor or laboratory manager /director.
• BD PrepStain™ supplies must be used. See
Materials required but not provided later in
this manual.
CAUTION
This instrument should be lifted and carried by grasping
unde
rneath the base. Do not use either of the blue front panels as
a lifting position. Never lift or carry the instrument by the front
panel.
CAUTION
Federal law restricts the use of thi
s instrument to applications
performed on the order of physicians or any other practitioner
licensed by the state to order testing associated with the
instrument. All users of the instrument and its thin-layer slide
products should be appropriately trained and experienced in its
use and specific associated tasks.