Hologic ThinPrep - Page 7

MAN-05359-001 -001 Rev. 001 page 3 of 32
The cytotechnologist can review the slides immediately after each slide is imaged (sequential modality)
or, as an alternative workflow for labs, slides can be imaged in succession, and coordinates stored in the
computer database for later cytotechnologist or pathologist review (batched modality).
D. LIMITATIONS
 Only personnel who have been appropriately trained should operate the ThinPrep Integrated Imager.
 All slides that undergo primary automated screening with the Integrated Imager require manual
rescreening of the selected fields of view by a cytotechnologist or pathologist.
 The ThinPrep Integrated Imager is only indicated for use with the ThinPrep Pap Test.
 The ThinPrep Integrated Imager is only indicated for the ThinPrep Pap Test slides prepared with the
ThinPrep
®
2000 System and the ThinPrep
®
5000 processor. The ThinPrep Integrated Imager is not
indicated for the ThinPrep Pap Test slides prepared with the ThinPrep
®
3000 processor.
 ThinPrep
®
slides with fiducial marks must be used.
 Slides must be stained using the ThinPrep Stain according to the applicable ThinPrep Integrated
Imager slide staining protocol.
 Slides should be clean and free of debris before being placed on the system.
 The slide coverslip should be dry and located correctly.
 Slides that are broken or poorly coverslipped should not be used.
 Slides used with the ThinPrep Integrated Imager must contain properly formatted accession number
identification information as described in the operator’s manual.
 Slides once successfully imaged on the Integrated Imager cannot be imaged again.
 The performance of the ThinPrep Integrated Imager using slides prepared from reprocessed sample
vials has not been evaluated; therefore it is recommended that these slides be manually reviewed.
E. WARNINGS
 The Integrated Imager generates, uses, and can radiate radio frequency energy and may cause
interference to radio communications.
 A Hologic authorized service representative must install the ThinPrep Integrated Imager.
F. PRECAUTIONS
 Caution should be used when loading and unloading glass slides on the ThinPrep Integrated Imager
to prevent slide breakage and/or injury.
 The Integrated Imager should be placed on a flat, sturdy surface away from any vibrating
machinery to assure proper operation.
G. PERFORMANCE CHARACTERISTICS
The ThinPrep Integrated Imager is technologically similar to the ThinPrep Imaging System. The
performance characteristics of the ThinPrep Integrated Imager were compared to the ThinPrep Imaging
System in a multi-center clinical study. The ThinPrep
®
Imaging System was compared to Manual