Iridex EndoProbe, Руководство оператора

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Clinical & Safety
13103F-EN
Regulatory compliance safety features for IRIS Medical lasers
The laser probes, and IRIDEX eye safety filters comply with 21 CFR
subchapter J as administered by the Center for Devices and Radiological
Health of the Food and Drug Administration (FDA).
CE-labeled devices comply with appropriate performance standards as
specified in Annex II of the Medical Device Directive MDD 93/42/EEC.
Eye safety filter
The eye safety filter ensures that all laser radiation returned to the
physician and any co-observers is below the Class I limit.
Laser emission indicator
Illumination of the green Treat light on the console provides a visible
warning that laser radiation may be emitted from the probe.
Safety interlocks
The probe is safety interlocked at the console fiber-optic receptacle to
prevent inadvertent laser emission when the probe is not fully connected.
Location of regulatory compliance and other system labels
CE label
REFERENCE
Refer to your laser
operator manual for
regulatory compliance
safety features specific
to your laser.