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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 HOSPITAL 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.

Summary of Contents for TOBI HOSPITAL

Page 1: ...ASPIRATEUR TOBI HOSPITAL CHIRURGISCHER ABSAUGER TOBI HOSPITAL ASPIRADOR QUIR RGICO TOBI HOSPITAL 28202 28232 28233 28234 M28202 M Rev 7 01 21 Gima S p A Via Marconi 1 20060 Gessate MI Italy gima gima...

Page 2: ...unstable surfaces which may cause it to acci dentally fall and lead to a malfunction and or breakage Should there be signs of damage to the plastic parts which may expose inner parts of the energised...

Page 3: ...ive and its normatives Under certain failure conditions the temperature of the casing may become hot and there may be a risk of burns if you touch those parts In any case the temperatures do not excee...

Page 4: ...anteed up to 30 cycles of cleaning and sterilization Beyond this limit the physical chemical characteristics of the plastic material may show signs of decay Therefore we recommend that you to change i...

Page 5: ...nd cooling at environment temperature of the parts make sure that these are not damaged The aspiration tubes can be sterilized on autoclave using a sterilization cycle at 121 C 1 bar relative pressure...

Page 6: ...After sales Assistance Service If the overfill security system it s activated don t proceede with the liquid aspiration If the overfill security system doesn t work there are two cases 1 case If the...

Page 7: ...e jar is reached there is the activation of the security float the float close the aspiration connector on the jar to avoid liquid penetration inside the device The device must be used on a plan of ho...

Page 8: ...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 a...

Page 9: ...it s used in such an environment Immunity Test Level indicated by the EN 60601 1 2 Compliance Level Electromagnetic environments guidance Electrostatic discharge ESD EN 61000 4 2 8kV on contact 15kV i...

Page 10: ...fixed RF transmitters as determined by an electromagnetic site study of the site should be less that the com pliance level in each frequency range Interference may occur in the vicinity of equipment...

Page 11: ...3 10 3 8 3 8 7 3 100 12 12 23 For transmitters with a maximum nominal output power not shown above the recommended separation distance in metres m can be calculated using the equation applicable to t...

Page 12: ...specifications may change without notice Disposal The product must not be disposed of along with other domestic waste The users must dis pose of this equipment by bringing it to a specific recycling p...

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