DYSIS Ultra 2.0 Digital Colposcope Instructions for Use
0330-53095 R4
Revision Date 25-Feb-2021
Page
3
of
61
1.
General Information
Thank you for purchasing the DYSIS Ultra 2.0 Digital Colposcope (DYS403), manufactured by DYSIS Medical Ltd.
Please read this guide carefully before using your equipment. DYSIS has been designed to maximize safety and
minimize 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 herein.
Refer to the Declaration of Conformity (0250-83339) for a list of the compliance standards and guidelines for the
DYSIS Ultra 2.0 Digital Colposcope. DYSIS Medical operates a Quality Management System that has been certified
for compliance with the requirements of ISO 13485:2016.
The CE mark on this product indicates it has been tested to and conforms to the provisions noted in the
93/42/EEC European Medical Device Directive.
USA Patent No 7749162
FDA 510(k) Clearance letter K092433
2.
Information for Intended Users and Patients
2.1.
Intended Users
The DYSIS Ultra 2.0 Digital Colposcope is a digital imaging system designed to assist clinicians in the
in vivo
evaluation, documentation and follow up of the lower genital tract.
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 who is trained in, and qualified to perform, colposcopic procedures
•
Language Understanding: English
Permissible Impairments: As applied in regular colposcopic practice
DYSIS Medical provides training on the setup and use of the device.
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.
2.3.
Contraindications and Side Effects
There are no specific contraindications for the use of the DYSIS Ultra 2.0 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.
