Operator's Manual
Table Of Contents
- Table of Contents
- 1 — Introduction
- 2 — Warnings, Cautions, and Other Residual Risks
- 3 — System Components
- 4 — Surgery Start Up
- 5 — Surgeon Settings
- 6 — Program Settings
- 7 — System Configuration
- Setting the Maximum IV Pole Height
- Testing the IV Pole
- Event Log
- Wireless Foot Pedal Setup
- VERITAS Remote Control Setup
- System Versions
- System Self Test
- Language Selection
- Surgical Media Center (SMC) (Optional)
- Set System Date and Time
- Set Units of Measure for Vacuum
- Service Interval
- Import/Export Database
- Backup All
- Print to File
- Restore Database
- Restore All
- Delete a Backup Database
- 8 — Symbol Definitions
- 9 — Care and Cleaning
- 10 — Error Messages, Troubleshooting, and Diagnostics
- 11 — Warranty and Maintenance
- 12 — Specifications
- Physical Specifications
- Environmental Specifications
- Electrical Specifications
- Electromagnetic Compatibility
- RF Wireless Technology
- Bluetooth Characteristics
- Phacoemulsification Specifications
- Irrigation and Aspiration Specifications
- Vitrectomy Specifications
- Diathermy Specifications
- Diathermy Power Graphs
- Diathermy Power versus Load Impedance
- Phaco Power Graphs
- Phaco Tip Velocity
- Bottle Height Pressure
- 13 — Accessories and Parts Reordering
- Index
Residual Risks Z370584 Rev. C
2-8
Warnings, Cautions, and Other Residual Risks
Residual Risks
The final Relative Residual Risk Level Rating for all VERITAS Vision System items was
determined to be either Low or Medium. Risk has been mitigated As Far As Possible (AFAP),
and is outweighed by the device's benefits.
Regulatory Symbol Definitions
The following symbols with regulatory relevance based on Reference Standards appear on
the VERITAS Vision System front and back panels.
Symbol Definition Reference Standard
Caution ISO 15223-1:2016
Medical devices – Symbols to be used with medical device
labels, labeling and information to be supplied – Part 1:
General requirements
Symbol reference #5.4.4
General warning sign IEC 60601-1:2005+AMD1:2012
Medical electrical equipment - Part 1: General requirements
for basic safety and essential performance
Symbol reference Table D.2 #2 (ISO 7010-W001)
Consult instructions for use ISO 15223-1:2016
Medical devices – Symbols to be used with medical device
labels, labeling and information to be supplied – Part 1:
General requirements
Symbol reference #5.4.3
Follow instructions for use IEC 60601-1:2005/(R)2012
Medical electrical equipment – Part 1: General requirements
for basic safety and essential performance
Symbol reference Table D.2 #10 (ISO 7010-M002)
Indicates compliance with
the Medical Device
Directive.
MDR 2017/745
Regulation (EU) 2017/745
Authorized Representative in
the European Community
ISO 15223-1:2016
Medical devices – Symbols to be used with medical device
labels, labeling and information to be supplied – Part 1:
General requirements
Symbol reference # 5.1.2