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CLEANING THE MAIN UNIT:

To clean the device external parts always use a cotton cloth dampened with detergent. Don’t use abra-

sive or solvent detergents.

PARTICULAR CARE SHOULD BE TAKEN TO ENSURE THAT THE INTERNAL PARTS OF THE 

EQUIPMENT DO NOT GET IN TOUCH WITH LIQUIDS. 

NEVER CLEAN THE EQUIPMENT WITH WATER.

During all clearing operations use protection gloves and apron (if need be, also wear a face mask and 

glasses) to avoid getting in contact with contaminating substances (after each utilization cycle of the 

machine).

ACCESSORIES SUPPLIED

N°2 COMPLETE ASPIRATION JAR 2000ml

CONICAL FITTING

TUBES SET 8 mm x 14 mm

ANTIBACTERIAL FILTER

FOOTSWITCH CONTROL (for versions equipped with footswitch control)

POWER CORD (H05VV-F - 2x0.75mm2 - 2mt)

Replacing the antibacterial filter:

The filter is made of hydrophobic material that stops the passage of liquids into the same filter.

If you suspect the filter may have been contaminated and/or got wet or discoloured, always remove and

replace the filter.

If the equipment is to be used on patients with unknown pathological conditions or should you evaluate

the possibility of indirect contamination, remove and 

replace the filter after each utilization

. The filter

is not designed for decontamination, disassembly and/or sterilization. If you suspect the filter may have

been contaminated and/or got wet or discoloured, always remove and replace the filter. If the equipment

is to be used on patients whose pathologies are known and not implying any indirect contamination

risks, we recommend to remove and replace the filter at the end of each work shift or else every month,

even if the equipment has not been used. 4000ml complete tank versions are available on request.

Aspiration jar:

 the mechanical resistance of the component is guaranteed 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 it.

Silicone tubes:

 the number of cycles of sterilization and/or cleaning is strictly linked to the employment 

of the said tube.

Therefore, after each cleaning cycle, it is up to the final user to verify whether the tube is suitable for 

reuse. The component must be replaced if there are visible signs of decay of the material constituting 

the said component.

Conical fitting:

 the number of cycles of sterilization and the number of cleaning cycles is strictly linked 

to the employment of the said component. Therefore, after each cleaning cycle, it is up to the final user 

to verify whether the fitting is suitable for reuse.

The component must be replaced if there are visible signs of decay in the material constituting the said 

component.

Service life of the device:

 more than 10000-12000 hours of operation (or 3 years) in accordance with the 

standard conditions of testing and operation. Shelf life: maximum 5 years from the date of manufacture.

WARNING:

 Suction tubes for insertion in the human body purchased separately from the machine 

should comply with ISO 10993-1 standards on material biocompatibility. The medical device is provided 

without a specific suction probe. If this device must be used with a specific suction probe, the end user is 

responsible for making sure it complies with the EN 10079-1 regulation.

CLEANING ACCESSORIES

Before using the device, the manufacturer advises you to clean and/or sterilize the accessories.

Washing and/or cleaning the autoclavable jar as to be carried out as follows:

• Wear protection gloves and apron (glasses and face mask if necessary) to avoid contact with

contaminating substances;

• Disconnect the tank from the device and remove the said container from the support of the device.

• Separate all the parts of the cover (overflow device, washer).

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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