DYSIS Ultra 2.0 Digital Colposcope Instructions for Use
0230-53095, Rev 05
Revision Date 05-Mar-2021
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Electromagnetic Interference
The use of diathermy equipment on the same electrical supply as DYSIS Ultra can cause electromagnetic
interference which is witnessed as an interruption to the video stream. Using a galvanic isolation transformer
between the a.c. mains supply and DYSIS Ultra can successfully prevent the interference.
3.
Optimal Use of the Pseudo-Colour Imaging (PCI) feature
When using the PCI feature, please ensure biopsies have adequate surface area to account for possible
image registration error (movement of the cervix whilst patient is undergoing examination) in the pseudo-
colour overlay map.
During the Dynamic Imaging procedure, which is used to generate a pseudo-colour map, it is important to
instruct the patient to remain as still as possible, otherwise the system will not be able to generate a map.
The DYSIS Ultra 2.0 Digital Colposcope is intended to be used in hospitals and clinics by users thoroughly
trained in the appropriate medical procedures.
DYSIS intended operator:
Education/ Minimum Knowledge:
A physician or a medical professional that is trained in, and qualified to perform, colposcopic
procedures
Language Understanding:
English
Minimum Experience:
Experience in the colposcopic procedures
Permissible Impairments:
As applied in regular colposcopic practice
4.
Summary of Warnings and Cautions
When using this system, always conduct a thorough colposcopy examination,
identifying and selecting areas for biopsy, before using the PCI feature to (possibly)
select additional biopsy sites. The DYSIS Ultra 2.0 Digital Colposcope with PCI has
not been shown to identify areas of cervical neoplasia. Therefore, never use this
system to omit a biopsy selected on the basis of the conventional colposcopy
examination.
Users of this equipment should be thoroughly trained in the appropriate medical
procedures and must read this guide carefully before operating this device. Failure
to do so may result in injury to the patient and/or damage to the device.
The following list summarises the warning, caution and information messages found in this guide.
(This Warning Symbol Applies to the Safety Warnings Below)