Hologic thinprep 2000 - Warnings; Precautions

MAN-02624-001 Rev. 003 page 4 of 15
WARNINGS
 For In Vitro Diagnostic Use
 PreservCyt Solution contains methanol, which is poisonous and may be fatal or cause
blindness if swallowed. Methanol vapor may be harmful. PreservCyt is flammable; keep
away from fire, heat, sparks, and flame. Other solutions must not be substituted for
PreservCyt Solution. PreservCyt Solution should be stored and disposed of in accordance
with local, state, and federal regulations.
 Do not process a cerebral spinal fluid (CSF) specimen or other sample type that is suspected
of possessing prion infectivity (PrPsc) derived from a person with a TSE, such as
Creutzfeldt-Jakob disease, on a ThinPrep processor. A TSE-contaminated processor cannot
be effectively decontaminated and therefore must be properly disposed of in order to avoid
potential harm to users of the processor or service personnel.
PRECAUTIONS
 Specific processing steps must be followed before and during use of the ThinPrep 2000 processor
if planning to perform Chlamydia trachomatis and Neisseria gonorrhoeae testing, using the Roche
Diagnostics COBAS AMPLICOR CT/NG test, on the residual specimen after a slide has been
prepared using a ThinPrep 2000 processor. Follow the procedures found in Chapter 5B of the
ThinPrep 2000 Operator’s Manual.
 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 15
o
C (59
o
F) and 30
o
C (86
o
F) and tested within 6 weeks of collection.
 PreservCyt Solution with cytologic sample intended for CT/NG testing using the Roche
Diagnostics COBAS AMPLICOR CT/NG test must be stored between 4
o
C (39
o
F) and 25
o
C (77
o
F)
and tested within 6 weeks of collection.
 PreservCyt Solution was challenged with a variety of microbial and viral organisms. The
following table presents the starting concentrations of viable organisms, and the number of viable
organisms found after 15 minutes in the PreservCyt Solution. The log reduction of viable
organisms is also presented. As with all laboratory procedures, universal precautions should be
followed.