DYSIS Ultra 2.0 Digital Colposcope Instructions for Use
0330-53095 R4
Revision Date 25-Feb-2021
Page
2
of
61
CONTENTS
1.
General Information
3
2.
Information for Intended Users and Patients
3
3.
Indications for Use
4
4.
Use of the Pseudo-Color Imaging (PCI) feature (DYSISmap
TM
)
4
5.
Summary of Warnings and Cautions
4
6.
Location of Product Labels
9
7.
Classifications (DYS403)
10
8.
Environmental Conditions
10
9.
Usage Restrictions
11
10. System and Components
12
11. Power Cord and Power On/Off (including shutdown)
15
12. List of Additional Components
15
13. Power On and Off
16
14. Overview of operation
17
15. The DYSIS Ultra 2.0 Software Application
17
16. Examination Preparation and Functions
21
17. DYSIS mapping
27
18. Patient Database
38
19. Additional Functions
44
20. Care, Maintenance and Troubleshooting
47
21. Warranty, Service, Expected Service Life, Recycling and Disposal
55
22. Contact Information
56
23. Essential Performance
56
24. Technical Description
57
25. Appendix 2: 60601-1-2 DATA
58
