DYSIS Ultra 2.0 Digital Colposcope Instructions for Use
0330-53095 R4
Revision Date 25-Feb-2021
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A risk assessment has been performed for the DYSIS Ultra 2.0 Digital Colposcope and all residual risks have been
assessed and reduced to as low as practicably possible. No undesirable side effects from using this device or
acetic acid (acetowhitening process) have been identified.
3.
Indications for Use
The DYSIS Ultra 2.0 Digital Colposcope with Pseudo-Colour Imaging (PCI) is a digital colposcope designed to
image the cervix and lower genital tract under illumination and magnification. Colposcopy is indicated for
women with an abnormal Pap smear in order to affirm normality or detect abnormal appearances consistent
with neoplasia, often with directed biopsy.
The PCI feature is an adjunctive tool for displaying areas of acetowhitening on the cervix. It is a tool that should
NOT be used as a substitute for a thorough colposcopic evaluation.
Please read the following operating and maintenance instructions thoroughly before using your new digital
colposcope. Following these instructions can help ensure many years of reliable service.
IMPORTANT: The material outlined in this manual should be reviewed and understood prior to operation of the
equipment.
IMPORTANT: The user of this equipment should be thoroughly trained in the medical procedures appropriate to
the instrumentation. Furthermore, time should be taken to read and understand these instructions before
performing any procedures. Instructions for other equipment used in conjunction with the DYSIS Ultra 2.0 Digital
Colposcope (e.g. electrosurgical equipment) should also be read and understood. Failure to do so may result in
injury to the patient and/or damage to the DYSIS Ultra 2.0 Digital Colposcope.
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.
4.
Use of the Pseudo-Color Imaging (PCI) feature (DYSISmap
TM
)
When using the PCI feature, please ensure biopsies have adequate surface area to account for possible image
registration error (movement of the cervix while the patient is undergoing examination) in the pseudo-color
overlay map.
During the dynamic imaging procedure, which is used to generate a pseudo-color 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.
5.
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. 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.
