Johnson & Johnson Surgical Vision Veritas, Operator'S Manual

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Residual Risks Z370584 Rev. D
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