Computer Network; Disposal - Essilor Instruments Vision-C 600 User Manual

b. Computer network
This instrument can transfer data to a computer or other devices via a USB or RJ45 interface.
These devices must comply with the standard IEC 62368-1. Purpose is to refraction data.
IT Network must be parametered in order to accept the text file from product address
(firewall parameters)
Transfer routines are compliant with FTP protocols.
No hazardous situation was reported through product design risk analysis.
External equipment intended for connection to signal outputs on the device shall comply with
the relevant product standard for such equipment IEC 62368-1 for IT-equipment. In
addition, all such combinations – Medical Electrical Systems – shall comply with the
requirements stated in clause 16 of IEC 60601-1. Any equipment not complying with the
leakage current requirements in IEC 60601-1 shall be kept outside the patient environment
(at least 1.5 m from the patient support or shall be supplied via a Separation transformer to
reduce the leakage currents).
Any person who connects external equipment to the device has formed a Medical Electrical System
and is therefore responsible for the system to comply with the requirements in clause 16 of IEC
60601-1. If in doubt, contact qualified medical technician or your local representative.
A Separation Device (isolation device) is needed to isolate the equipment located outside the
patient environment from the equipment located inside the patient environment. In particular such
a Separation Device is required when a network connection is made. The requirement for the
Separation Device is defined in clause 16.5 of IEC 60601-1.
Connecting this instrument to a computer network that includes other equipment may result in
safety and data protection risks.
The responsible organization is expected to identify, analyze, evaluate and control these risks.
Any subsequent changes to the computer network may cause risks and require further analysis.
These changes include:
changing the configuration of the computer network;
connection of additional devices to the computer network,
disconnection of elements of the computer network,
updating the equipment connected to the computer network;
upgrading the equipment connected to the computer network.
Please contact your distributor for detailed information on this instrument.
c. Disposal
Instructions for the disposal of the instrument in accordance with Directives 2012/19/EU
and 2011/65/EU regarding the limitation of dangerous substances in electrical and
electronic equipment and the disposal of electrical and electronic waste.
When it reaches the end of its lifetime, the instrument should not be thrown out with the
household refuse. It can be disposed of at a waste management center operated by the
municipality or the retailers who offer this service. The separate disposal of an electrical
device avoids any damage to the environment or health that could result from a non-
compliant disposal, and also allows the materials it is composed of to be recycled in order
to save energy and resources. The pictogram of the wheeled container appears on the label
of the instrument. It indicates the obligation for separate collection and disposal of end-of-
life/out-of-use electrical and electronic equipment.
Vision-C 600 - Polarized visual chart system > V1- 02-2021 (VRSQSE)
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