❖ The clinical interpretation of the images acquired by the drsplus is restricted to
licensed eye care practitioners.
❖ Use of the device is restricted to operators who have undergone the necessary
training.
❖ Do not open the device in order to prevent the risk of electrocution and damage
to the device itself.
❖ Do not use the device if the covers or other parts of the device have been
removed.
❖ Only technicians authorized by CenterVue may service the drsplus. CenterVue
cannot be held responsible for the device safety should drsplus be opened,
repairs carried out, third-parties’ software be installed, or parts be replaced by
an unauthorized person.
❖ Avoid all contact with water: risk of fire or electric shock.
❖ Stand clear from moving parts during operation.
❖ The device is equipped with an earth connection by means of a protective
conductor inside the power cable. Before switching on the device, check that the
power outlet is correctly earthed to avoid the risk of electrocution.
❖ The drsplus must be used in a room with an electrical system that complies with
applicable healthcare environment safety regulations.
❖ The drsplus power supply must be connected to a socket with a circuit breaker.
❖ The drsplus must NOT be used in an oxygen-rich environment or in presence of
flammable anesthetics.
❖ External devices connected to the drsplus, into the patient environment, must
comply with IEC 60601-1. Those devices that do not comply with the IEC 60601-1
must be kept out of the patient environment, and must comply with IEC 60950.
Any operator who connects external devices to drsplus creates a new Medical
Electrical System as defined by IEC 60601-1 and is therefore responsible of the
conformity of such system with the requirements defined in clause 16 of
IEC 60601-1. Please contact the local distributor for any additional information.
❖ When in operation, drsplus contains Personal Data.
IT IS THE OPERATOR’S RESPONSIBILITY TO KEEP AND MAINTAIN AN UPDATED
COPY OF THE DATA GENERATED BY THE drsplus THROUGH REGULAR USE OF THE
BACKUP FACILITY, THUS PREVENTING THE RISK OF ACCIDENTAL LOSS OF DATA.
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