Leica Envisu C Series User Manual

Hardware User Manual
Envisu C-Series SDOIS / 9054-10011 / Revision N 10
Caution! Phototoxicity
While no acute optical radiation hazards have been identified for direct or
indirect ophthalmoscopes, it is recommended that the intensity of light
directed into the subject’s eye be limited to the minimum level which is
necessary for diagnosis. Infants, persons with aphakia and other diseases
of the eyes will be at greater risk. The risk may also be increased if the
person being examined has had any exposure with the same instrument or
any other ophthalmic instrument using a visible light source during the
previous 24 hours. This will apply particularly if the eye has been exposed to
retinal photography.*
*Note: The Phototoxicity cautions listed above are mandatory text as defined in the CDRH guidance
document #71, “Ophthalmoscope Guidance (Direct and Indirect).”
The Envisu
TM
Spectral Domain Ophthalmic Imaging System (SDOIS)
complies with the Group 2 instrument requirements of ISO 15004-
2:2007.
CAUTION - The light emitted from this instrument presents a potential
thermal hazard to the cornea and lens. The longer the duration of
exposure, the greater the risk of ocular damage. The maximum corneal and
lenticular infrared radiation irradiance emitted from this instrument is
95mW/cm2 when operated at worst case conditions (i.e., no eye movement
and with non-scanning beam). This value is 5% below the safety guideline
(100 mW/cm
2
) specified in ISO15004-2: 2007.**
**Note: This cautionary statement is mandatory text as defined in ISO 15004-2:2007 for Group 2
ophthalmic instruments.
Safety
Operational Safety
Warning! Danger of High Voltage
Do not remove component covers. Installation, assembly, service, and
maintenance must be performed by the manufacturer or an authorized
service representative only.
Warning! Danger of High Voltage
The signal input parts or signal output parts (SIP/SOP) need to be
connected properly and should never be connected to AC powered devices
when conducting a patient exam.
Warning! Danger of High Voltage
The only direct disconnection from the mains is by unplugging the system
power cable from the wall socket. Keep the power plug accessible at all
times during the system operation.

Leica Envisu C Series Specifications

General

Brand	Leica
Model	Envisu C Series
Category	Laboratory Equipment
Language	English