DYSIS Ultra 2.0 Digital Colposcope Instructions for Use
0230-53095, Rev 05
Revision Date 05-Mar-2021
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Essential Performance
DYSIS is a digital colposcope that enables clinicians to illuminate and visualize the cervix uteri so that they
perform a colposcopic examination. Typically, colposcopy is performed on women that have been referred
after a screening test (cytology and/or cytology) indicated suspicion for disease. The purpose of colposcopy is
to visually evaluate the cervix, perform a series of assessments (most importantly, the assessment of:
acetowhitening, iodine staining, vessel morphology, lesion morphology) and then decide (following national
and local guidelines) the appropriate management. Management options may include biopsy sampling for
histopathological diagnosis, discharge to routine screening, surveillance or immediate treatment. Diagnosis is
only provided by histopathology review of biopsy samples, and with respect to biopsy, the role of the
colposcopist is to decide which locations on the cervix should be biopsied and then take the samples.
Failure to perform a colposcopy does not introduce a significant risk
to the patient’s well
-being as it can be
repeated at a later time. The progression of cervical disease is rather slow, so a few hours or days of delay do
not introduce a risk.
The DYSISmap, included as a distinct additional feature on the DYSIS device, provides clinicians a means to
obtain an objective impression of the acetowhitening in a simple-to-read way. Clinicians may (or may chose
not to) include the DYSISmap information in their assessment, i.e. as an element added to the list above. The
DYSISmap is an adjunctive tool that does not suggest a diagnosis of a cervical condition and never obliviates
the need for a thorough visual colposcopy. Furthermore, biopsies decided based on visual colposcopy should
never be cancelled because of the DYSISmap.
The DYSISmap is an adjunct, and as such, a thorough colposcopic examination is performed irrespective of it.
Furthermore, the DYSISmap is not used to cancel an otherwise appropriate biopsy, so disease will not be
missed because of a DYSISmap failure.
Neither the DYSIS device nor the DYSISmap are diagnosis aids, and even more so, as colposcopy that they are
used for is not intended to provide a direct diagnosis of a patient’s condition.
In conclusion, use of the DYSIS Ultra 2.0 Digital Colposcope does not depend on essential performance.