CenterVue
DRS Operating Manual
Pg. 11 of 59
7. WARNINGS AND PRECAUTIONS
The following precautions are particularly relevant to the device safety:
Federal laws (US) restrict this device to sale by or on the order of a physician or a
properly licensed practitioner.
The clinical interpretation of DRS images is restricted to licensed eye care
practitioners.
A device specific training is required for any operator to become able to use the
system.
Do not open the device: this could lead to electric shocks or damage to the system.
Do not use the instrument in the event that the cover or other parts of the device
have been removed.
Only technicians authorized by CenterVue may service the DRS. CenterVue
cannot be held responsible for system safety should the DRS be opened, repairs
carried out, third parties software be installed, or parts be replaced by unauthorized
persons.
Do not expose the device to water: this could lead to fire or electric shock.
Stand clear from moving parts during operation.
All parts in contact with a patient’s skin need to be disinfected after use
(see par. 17).
The instrument is supplied with an earth ground by means of a protection
conductor contained inside the power supply cable. Before turning on the system,
make sure the power supply socket is correctly grounded to avoid the risk of
electric shock.
The room where the DRS is operated must respect IEC or ISO safety standards
relative to medical use of a room or area.
The DRS must NOT be used in an oxygen rich environment or in presence of
flammable anesthetics.
External equipment connected to the DRS within the patient environment must be
compliant with IEC 60601. Equipment not complying with IEC 60601-1 shall be
kept outside the patient environment and complying with IEC 60950. Any person
who connects external equipment to signal input, signal output or other connectors
of the DRS has formed a Medical Electrical System according the definition of
IEC 60601-1 and is therefore responsible for the system to comply with the
requirements of IEC 60601-1, § 16. If in doubt, contact the local representative.
Data Backup: DRS contains Patient Health Information. It is strongly
r
ecommended the use of the “backup” utility as indicated at the Chapter “System”.
The following precautions are particularly relevant to prevent use errors:
The device must be placed in a room which is not exposed to adverse chemical-
physical conditions, such as the presence of sulfur, salt, dust, direct sunlight, lack
of ventilation, high humidity, sudden temperature drops or peaks. The safety and/or
effectiveness of the instrument cannot be guaranteed if these conditions are not
fulfilled.
The DRS needs to be operated in a semi dark room (except when taking Anterior
Eye photos).
The DRS needs to be operated under the following environmental conditions:
Temperature: 10 - 40 C° (50 - 104 F°) / Humidity (max): 90% not condensing
