Hardware User Manual
Envisu C-Series SDOIS / 9054-10011 / Revision N 6
Intended Use & Contraindications
Leica Envisu
TM
Spectral Domain Ophthalmic Imaging system is intended to acquire, process,
display and save depth-resolved images of ocular tissue microstructure using Spectral Domain
Optical Coherence Tomography (SD-OCT).
The Envisu
TM
SDOIS is indicated for use as an aid in the diagnosis of physiologic and pathologic
conditions of the eye through non-contact optical imaging. Imaging of the various tissues of the
eye is supported through the use of interchangeable lenses. It is indicated for use on patient
populations from premature and neonatal infants to adult, and is suitable for patients ambulatory
or confined. The system is indicated for use in upright or supine imaging, handheld or mounted,
and is suited for imaging patients under anesthesia.
IMPORTANT! Read and understand the entire user’s manual before
operating this system. If you have any questions concerning
the use of this system, contact customer service.
Users of this system should be physicians or technicians with professional training or
experience in the use of retinal imaging equipment.
Contraindications
This device is a Class 1 Laser product in accordance with the IEC 60825-1:Ed 1.2 standard.
As a good practice, subject retina should not be exposed to the direct output of this device for
any longer than necessary for obtaining images.
CAUTION! Use of controls or adjustments or performance of procedures
other than those specified herein and any companion
documents may result in hazardous radiation exposure.
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