DYSIS Ultra 2.0, Instructions For Use Manual, Page: 2 / 79

DYSIS Ultra 2.0 Digital Colposcope Instructions for Use
0230-53095, Rev 05
Revision Date 05-Mar-2021
Page 2 of 79
CONTENTS
1. Applicable Standards ......................................................................................................... 4
2. General Description ........................................................................................................... 5
3. Indications for Use ............................................................................................................. 5
4. Optimal Use of the Pseudo-Colour Imaging (PCI) feature ................................................. 6
5. Summary of Warnings and Cautions ................................................................................. 6
5.1. Location of Labels ............................................................................................................ 10
6. Classifications (DYS403) ................................................................................................... 12
7. Environmental Conditions ............................................................................................... 13
7.1. Storage ............................................................................................................................ 13
7.2. Usage ............................................................................................................................... 13
7.3. Transportation ................................................................................................................. 13
7.4. Atmospheric Pressure ..................................................................................................... 13
8. Usage Restrictions ........................................................................................................... 13
9. Components of DYSIS Ultra 2.0 Digital Colposcope ........................................................ 14
9.1. BASE / Moving the Instrument ........................................................................................ 14
9.2. ARMS ............................................................................................................................... 14
9.3. Clinician Monitor ............................................................................................................. 15
9.4. Optical Head .................................................................................................................... 15
9.4.1. Camera and Light ............................................................................................................. 15
9.4.2. DYSIS Acetic Acid Applicator............................................................................................ 16
9.4.3. Speculum Connector (coupling adapter) ......................................................................... 16
10. Power cord and Power On/Off (including shutdown) ..................................................... 17
11. Assembling and inserting the power cord ....................................................................... 17
12. List of Additional Components ........................................................................................ 17
13. Powering on the DYSIS Ultra 2.0 Digital Colposcope ....................................................... 19
14. Powering Off the DYSIS Ultra 2.0 Digital Colposcope ...................................................... 19
15. Overview – Operating DYSIS Ultra 2.0 Digital Colposcope .............................................. 19
16. DYSIS Acetic Acid Applicator Kit ...................................................................................... 20
17. Positioning for an examination ....................................................................................... 20
18. DYSIS Ultra 2.0 Digital Colposcope Software Application ............................................... 21
18.1. Logging In ........................................................................................................................ 21
18.2. Home Menu ..................................................................................................................... 21
18.3. General navigation buttons ............................................................................................. 23
18.4. Creating a New Patient Record ....................................................................................... 23
18.5. New Visit for an Existing Patient ..................................................................................... 25
19. DYSIS Examination Preparation and Functions ............................................................... 26
19.1. Adding data to a Patient visit record ............................................................................... 26
19.2. Using DYSIS to perform examination of the Lower Genital Tract without mapping ....... 27
19.3. Assigning a visit after a DYSIS Exam from Home screen.................................................. 30
19.4. Using DYSIS Ultra to carry out a standard colposcopic examination .............................. 30
19.5. Preparing the patient ...................................................................................................... 31
19.6. Additional Options ........................................................................................................... 33
20. Starting the DYSIS Exam .................................................................................................. 33
21. Using DYSIS Ultra 2.0 Digital Colposcope IN TRIAL mode ................................................ 37
21.1. The DYSIS Map ................................................................................................................. 40
21.2. Dynamic curves ............................................................................................................... 41
21.3. Adding additional biopsy markers ................................................................................... 42
21.4. Biopsy point viewing ....................................................................................................... 42
21.5. Exiting the Exam .............................................................................................................. 42
22. Additional information post colposcopic examination ................................................... 42
23. Patient Database ............................................................................................................. 46
23.1. Reviewing a visit .............................................................................................................. 46
23.2. Visit History ..................................................................................................................... 48