DYSIS Ultra 2.0 Digital Colposcope Instructions for Use
0230-53095, Rev 05
Revision Date 05-Mar-2021
Page
9
of
79
The DYSISmap
TM
is not meant to replace conventional colposcopic assessment and decisions regarding biopsy
treatment or diagnosis. The assessment of acetowhitening should be based on visual inspection of the entire
set of the acetowhitening characteristics. The DYSISmap reflects a subset of them.
When using different concentrations of acetic acid, the acetowhitening characteristics may change and
consequently the correspondence of the DYSISmap colour coding to certain degrees of acetowhitening.
When adjusting the image brightness, the practitioner should ensure viewing the monitor directly and not
from the side or from below, as this may distort the perception of the colour and brightness.
Before a DYSISmap measurement, check there is a sufficient volume of acetic acid solution in the container.
The acetic acid container holds 30ml of acetic acid and the software provides a prompt to the user that there
is 15ml (10 exams) left in the container.
While the DYSISmap measurement is in progress, do not obscure the light beam or the camera. While the
DYSISmap measurement is in progress, patient movements should be minimised.
The user annotations are digital marks overlaid on the displayed image and do not follow the movements of
the cervix. Therefore, the annotations should be used with caution if the cervix moves after the marking.
Access to the database is password controlled and therefore restricted for unregistered users.
The
“Required” marked fields in the “New Patient” form are mandatory. The patient data
is saved only upon
pressing
SAVE
.
USB disks used for exporting data (images/ report) should be in
exFAT
file format.
In addition to the device label, the following warning labels are found on the DYSIS Ultra 2.0 Digital Colposcope
or within this document:
The disposable speculum is a Type-B
applied part that provides
protection against electric shock.
The attachable speculum, if
reusable, is a Type-BF applied part
that provides protection against
electric shock.
CONSULT: Refer to instruction
manual/booklet
NOTE: This symbol is used to signify
the instruction manual/booklet
must be read
General warning sign.