Hologic ThinPrep 5000, Operator'S Manual

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ThinPrep™ 5000 Processor with AutoLoader Operator’s Manual
1.5
1
I
NTRODUCTION
ThinPrep-prepared slides by Hologic or by organizations or individuals designated by
Hologic.
• Supplies used in the ThinPrep 5000 system are those designed and supplied by Hologic
specifically for the ThinPrep 5000 system. These include PreservCyt Solution vials, ThinPrep
Pap test filters, and ThinPrep microscope slides. Alternative collection media, filters, and
slides have not been validated by Hologic and may lead to erroneous results. Hologic does
not provide a warranty for results using any of these alternatives. Product performance may
be compromised if upplies that have not been validated by Hologic are used. After use,
supplies should be disposed of in accordance with local, state, and federal regulations.
• A ThinPrep filter must be used only once and cannot be reused.
• A ThinPrep microscope slide must be used only once. A microscope slide onto which
specimen has been transferred cannot be reused.
• The performance of HPV DNA and CT/NG testing on sample vials reprocessed with glacial
acetic acid (GAA) has not been evaluated.
Contraindications
•
Chlamydia trachomatis
and
Neisseria gonorrhoeae
testing using Hologic’s APTIMA COMBO 2
™
CT/NG assays and the Roche Diagnostics COBAS AMPLICOR assay should not be
performed on a sample that has already been processed using the ThinPrep 5000 processor
with AutoLoader.
Warnings
• For
In Vitro
diagnostic use.
• Danger. PreservCyt contains methanol. Toxic if swallowed. Toxic if inhaled. Causes damage
to organs. Cannot be made non-poisonous. Consult Safety Data Sheet (SDS) at
www.hologicsds.com. Wear personal protective laboratory gear. Flammable liquid and
vapor. Keep away from heat, sparks, open flames and hot surfaces. Evaporating alcohol
could create a fire hazard. PreservCyt Solution should be stored and disposed of in
accordance with all applicable regulations.
• Alternative collection media, filters, and slides have not been validated by Hologic and may
lead to erroneous results. Hologic does not provide a warranty for results using any of these
alternatives.
• Strong oxidizers, such as bleach, are incompatible with PreservCyt Solution and therefore
should not be used to clean the waste bottle.
Precautions
• This equipment generates, uses, and can radiate radio frequency energy, and if not installed
and used in accordance with the Operator’s Manual, may cause interference to radio
communications. Operation of this equipment in a residential area is likely to cause harmful