DYSIS Ultra 2.0 Digital Colposcope Instructions for Use
0230-53095, Rev 05
Revision Date 05-Mar-2021
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2.
General Description
Thank you for purchasing the DYSIS Ultra 2.0 Digital Colposcope, manufactured by DYSIS Medical. Please read
this guide carefully before using your equipment. DYSIS has been designed to maximize safety and minimise
strain for users and patients. However, precautions must be taken to further reduce risk of personal injury or
damage to the device.
Be careful to follow the general precautions in this User Guide and note the cautions included. To maintain
your DYSIS Ultra 2.0 Digital Colposcope in good working condition, please follow the operation and
maintenance procedures described here-in.
2.1.
Intended Users
The DYSIS Ultra 2.0 Digital Colposcope is a digital image Colposcope designed to assist clinicians in the
in vivo
evaluation, documentation and follow up of cervical pathology.
2.2.
Intended Patients
The DYSIS Ultra 2.0 Digital Colposcope is intended to be used on patients undergoing a colposcopic
examination in hospitals and clinics by healthcare providers who are trained in the relevant medical
procedures. The DYSIS intended operator is a medical professional trained in the examination of the cervix
vagina and vulva.
2.3.
Contraindications
There are no specific contraindications for the use of the DYSIS Digital Colposcope on patients, other than
any relative contraindications to a patient having a colposcopic procedure in general. These have to be
evaluated and determined by the healthcare provider, and may include the patient's ability to tolerate a
standard speculum examination, conditions that may be best treated in advance such as acute cervicitis and
severe vaginitis, anticoagulant use, or heavy bleeding.
2.4.
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 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 Digital Colposcope.