Risk Of Electromagnetic Interference And Possible Remedies - Gima TOBI CLINIC Manual Del Usuario

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Footswitch control device:
The equipment, on request, is provided with a footswich control device. It allows the continuous use of
the surgical aspirator. In this case, the plug of the footswitch device shall be inserted into the appropriate
socket outlet placed on the back side of the equipment.
Near the ON/OFF Switch, there is a commutator that operates the device directly using the mains or by
using the footswitch control.
When the switch is turned on (green light) and the commutator is in position I, the device works directly
using the mains.
When the switch is turned on (green light) and the commutator is in position II, the device works via
remote control (footswitch control).
When the switch is turned on (green light) and the commutator is in position 0, the device is powered but
not in operation.
Using FLOVAC® disposable collection system:
Before connecting the disposable collection system, remove the blu ring fitted on the tank holder for a
more comfortable insertion of the same container.
After opening the package, fully stretch the bag and then flatten it concentrically to eliminate as much
air as possible.
Insert the bag and apply the cover to an appropriately sized reusable rigid container by pressing firmly
around the entire perimeter. Make sure that the system is completely sealed.
close the connector marked as "TANDEM" with the lid provided.
Connect the power source of the vacuum to the VACUUM port equipped with specific reusable conical
fitting with "male" connection.
Connect the patient tube to the PATIENT port of the cover
Before use, check all closures and make sure there are no leaks, starting the aspiration source. If the
bag expands to fully adhere to the walls of the rigid container and the cover bends towards the inside
of the glass, the system is not leaking.
Start the aspiration and periodically check the filling level of the container. The overflow valve will cause
the interruption of aspiration if the aspirated fluids have reached the maximum filling level of the device.
When the float valve intervenes signalling the device is too full, the suction source must be disconnected
within no more than 5 minutes.
Warning: The accidental inversion of connections may cause contamination for the operator and/
or for the vacuum generation equipment.
NEVER USE THE DEVICE WITHOUT JAR AND / OR PROTECTION FILTER.

RISK OF ELECTROMAGNETIC INTERFERENCE AND POSSIBLE REMEDIES

This section contains information regarding the conformity of the compliance with the EN 60601-1-2
Standard.
The TOBI CLINIC surgical aspirator is an electro-medical device that requires particular precautions
regarding electro-magnetic compatibility and which must be installed and commissioned according to the
electro-magnetic compatibility information supplied. Portable and mobile radio communication devices
(mobile phones, transceivers, etc.) may interfere with the medical device and should not be used in close
proximity with, adjacent to or on top of the medical device.
If such use is necessary and unavoidable, special precautions should be taken so that the electro-medical
device functions properly in its intended operating configuration (for example, constantly and visually
checking for the absence of anomalies or malfunctions).
The use of accessories, transducers and cables different to those specified, with the exception of
transducers and cables sold by the appliance and system manufacturer as spare parts, can lead to an
increase in emissions or in a decrease of the immunity of the device or system. The following tables
supply information regarding the EMC (Electromagnetic Compatibility) characteristics of the electro-
medical device.
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