Hologic ThinPrep 5000 Instruction Manual page 4

LIMITATIONS

Gynecologic samples collected for preparation using the ThinPrep 5000 processor should be collected
using a broom-type or endocervical brush/plastic spatula combination collection devices.

Preparation of microscope slides using the ThinPrep 5000 processor should be performed only by
personnel who have been trained by Hologic or by organizations or individuals designated by
Hologic.

Evaluation of microscope slides produced with the ThinPrep 5000 processor should be performed
only by cytotechnologists and pathologists who have been trained to evaluate ThinPrep-prepared
slides by Hologic or by organizations or individuals designated by Hologic.

Supplies used by the ThinPrep 5000 processor are those designed and supplied by Hologic specifically
for the ThinPrep 5000 processor. These include PreservCyt Solution vials, ThinPrep Pap test filters,
and ThinPrep microscope slides. These supplies are required for proper performance of the system and
cannot be substituted. Product performance will be compromised if other supplies are used. After use,
supplies should be disposed of in accordance with local, state, and federal regulations.

A ThinPrep Pap test filter must be used only once and cannot be reused.

The performance of HPV DNA and CT/NG testing on reprocessed sample vials has not been
evaluated.
CONTRAINDICATIONS

Chlamydia trachomatis and Neisseria gonorrhoeae testing using the Hologic APTIMA COMBO 2
CT/NG assay and the Roche Diagnostics COBAS AMPLICOR assay should not be performed on a
sample that has already been processed using the ThinPrep 5000 processor.
WARNINGS

For In Vitro Diagnostic Use

Danger. PreservCyt Solution contains methanol. Toxic if swallowed. Toxic if inhaled. Causes
damage to organs. Flammable liquid and vapor. Keep away from heat, sparks, open flames and
hot surfaces. Other solutions cannot be substituted for PreservCyt Solution. PreservCyt Solution
should be stored and disposed of in accordance with all applicable regulations.
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 interference, in which case
the user will be required to correct the interference at his/her own expense.
 PreservCyt Solution with cytologic sample intended for ThinPrep Pap testing must be stored between
o o
15 C (59 F) and 30

PreservCyt Solution with cytologic sample intended for CT/NG testing using the Roche Diagnostics
COBAS AMPLICOR CT/NG test must be stored between 4
within 6 weeks of collection.
o o
C (86 F) and tested within 6 weeks of collection.
o o o o
C (39 F) and 25 C (77
MAN-04008-001 Rev. 001
®
F) and tested
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