Safety and Compliance 12
Safety Compliance
Complies with FDA performance standards for laser products, except for deviations pursuant to
Laser Notice No. 50, dated June 24, 2007.
The IRIDEX
®
LIO Plus is compliant with EC directive 93/42/EEC and subsequent amendments.
Feature
Function
Eye safety filter
The eye safety filter ensures that all laser radiation returned to the physician and any
co-observers is below Class I limits.
Laser emission indicator Illumination of the green Treat light on the laser provides a visible warning that
laser radiation may be emitted.
Safety interlock
The delivery device’s protective housing and the laser fiber connector
cannot be opened without the use of special tools. The delivery device is
also safety-interlocked at the fiber-optic port on the laser.
The IRIDEX LIO Plus is classified as a Group 1 instrument according to EN ISO 15004-2:2007.
This classification was determined using a 20D ophthalmoscopy lens.
The IRIDEX LIO Plus is classified as a Group 1 instrument according to ANSI Z80.36-2016.
This classification was determined using a 20D ophthalmoscopy lens.