USER MANUAL 16-2090
Rev. 09/2017
Page 5 of 27
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The device must be opened only by a competent technician authorized by the manufacturer.
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Do not insert metal objects into the device. This is to avoid any risk of electrical shock, fire, short-
circuit or hazardous emissions.
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Do not expose the device to splashed water or to humidity.
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Use only the accessories supplied with the device or as recommended by the manufacturer.
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This camera is not a flame-proof device. It must not be used in the presence of flammable
anaesthetics.
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This device was not designed to be used in an ionising environment.
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This device is not sterile.
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The surface temperature of the camera can reach 41°C (after a few minutes’ use). Avoid any
contact with this area.
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The camera is intended for use by qualified, trained professionals, in an operating theatre.
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Prior to plugging in the device, check that the mains voltage and mains frequency indicated on
the device corresponds to the power system values.
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Prior to activation, ensure that neither the device nor the power cable is damaged. Damaged
cables and/or connectors must be replaced immediately.
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Do not drop the device. If the device falls, do not reconnect the device but send it back to your
authorized distributor.
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No additional multiple-socket outlets or extension cords must be connected to the EM system.
To avoid any risk of electrical shock, this device must be connected only to a power system
equipped with protective grounding.
Devices connecting to the input/output ports must comply with the IEC 60950-1 standard.
Any modification of this device without authorization of the manufacturer is prohibited. If the
medical device is modified, an inspection and a test must be carried out to ensure that the medical
device complies with the safety regulations.
Check with the distributor for the compatibility of your endoscope and your light source, prior to
use.
It is advisable to have a second surgical camera in the operating theatre so that action can be
taken if the device fails to perform or if deterioration in performance is noticed.
This device is to be used on individuals (patients) fit to undergo an endoscopic procedure.
The potential equalization plug located at the back of the Fusion unit can be used to equalize the
grounding potential of the medical device with that of all the devices plugged into the main power in the
environment. Use the shared grounding system in the hospital or the building.
Third party cables and accessories may negatively affect EMC performance.
Stacking and locating the device close to other equipment may negatively affect EMC
performance.
