Hologic ThinPrep, Operator'S Manual

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MAN-08723-001 Rev. 001 page 3 of 28
D. LIMITATIONS
•
Only personnel who have been appropriately trained should operate the ThinPrep
®
Imaging
System Image Processor or Review Scope.
• All slides that undergo primary automated screening with the Image Processor require manual
rescreening of the selected fields of view by a Cytotechnologist using a Review Scope.
•
The ThinPrep Imaging System is only indicated for use with the ThinPrep Pap Test.
•
The laboratory Technical Supervisor should establish individual workload limits for personnel using the
ThinPrep Imaging System.
The maximum daily limit specified is only an upper limit and should never be used
as an expectation for daily productivity or as a performance target.
• The ThinPrep Imaging System has not been proven to be safe or effective at workload levels
which exceed product labeling.
•
ThinPrep slides with fiducial marks must be used.
•
Slides must be stained using the ThinPrep Stain according to the applicable ThinPrep Imaging
System 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 Imaging System must contain properly formatted accession number
identification information as described in the operator’s manual.
•
Slides once successfully imaged on the Image Processor cannot be imaged again.
•
The performance of the ThinPrep Imaging System using slides prepared from reprocessed sample
vials has not been evaluated; therefore it is recommended that these slides be manually reviewed.
E. WARNINGS
•
The 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 Imaging System.
F. PRECAUTIONS
•
Caution should be used when loading and unloading glass slides on the ThinPrep Imaging System
to prevent slide breakage and/or injury.
• Care should be taken to assure that slides are correctly oriented in the ThinPrep Imaging System
cassettes to prevent rejection by the system.
•
Partially processed slide cassettes should not be removed from the Image Processor, as data may
be lost.
• The Image Processor should be placed on a flat, sturdy surface away from any vibrating
machinery to assure proper operation.