PROFESSIONAL MEDICAL PRODUCTS
ASPIRATORE CHIRURGICO TOBI MANUALE
TOBI MANUALE SUCTION ASPIRATOR
ASPIRATEUR TOBI MANUEL
CHIRURGISCHER ABSAUGER “TOBI MANUALE”
ASPIRADOR QUIRÚRGICO “TOBI MANUALE”
APARELHO DE SUCÇÃO CIRÚRGICO “TOBI MANUALE”
28220
Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
gima@gimaitaly.com - export@gimaitaly.com
www.gimaitaly.com
M28220-M-Rev.7-02.21
Made in Italy
0476
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TOBI MANUALE SUCTION ASPIRATOR it’s a manual device to be used for the emergency eld to be used
for the aspiration of the body liquids (mucus or catarrh or blood). Easily movable and designed for a manual
use. Thanks to this characteristics and to the rating that it has product is particularly suitable for a emergency
use, on the thacheotomized patients, minor surgical applications and post - operative therapy at home. Made
of highly heat resistant, in conformity with the latest European safety standard, the product is supplied with a
polycarbonate 0.4 litre autoclavable jar with overow valve.
ENGLISH
GENERAL WARNING
Read instruction manual carefully before use.
Only highly qualied staff use reserved the instrument must not disassembled.
For technical service always contact Gima S.p.A.
IMPORTANT SAFETY RULES
1. Check the condition of the unit before each use.
2. Respect the safety regulations indicated for electrical appliances and particularly:
- Use original components and accessories provided by the manufacturer to guarantee the highest efciency and safety of the device;
- The device can be used only with the bacteriological lter;
- Place instrument on stable and at surfaces;
- Don’t touch the device with wet hands and always prevent the appliance coming into contact with liquids;
- Keep off the reach of children or not capable people without supervision;
- Preserve and use the medical device in environments protected from atmospheric factors and at distance
from heat sources;
- Don’t use the device thoracic drainage.
3. For repairs, exclusively contact technical service and request the use of original spare parts. Failure to
comply with the above can jeopardise the safety of the device.
4. Use only for the purpose intended. Don’t use for anything other than the use dened by the manufacturer. The manufacturer will not be responsible for damage due to improper use.
5. Instrument and accessory discharging must be done according to current regulations in the country of use.
6. None of mechanical parts have been designed to be repaired by customers or end-users. Don’t open the
device, do not mishandle the mechanical parts. Always contact technical assistance.
7. Using the device in environmental conditions different than those indicated in this manual may harm seriously the safety and the technical characteristics of the same.
The manufactured cannot be held liable for accidental or indirect damages should the device be modied, repaired without authorization or should any of its component be damaged due to accident or misuse.
Any minimal modication / repair on the device voids the warranty and does not guarantee the compliance with
the technical requirements provided by the MDD 93/42/EEC (and subsequent changes) and its normatives.
TECHNICAL CHARACTERISTICS
Model TOBI MANUALE SUCTION ASPIRATOR
TIPOLOGY (MDD 93/42/EEC) Medical Device Class IIa
Classication UNI EN ISO 10079-2 MEDIUM VACUUM / 22l/min
Maximum suction aspiration (without jar) -40kPa (- 0.40 bar)
Weight 1.150 Kg
Dimension 225 x 165 (h) x 85 mm
Working condition Room temperature: 5 ÷ 35°C
Conservation condition Room temperature: - 40 ÷ 70°C
Room humidity percentage: 30 ÷ 75% RH
Altitude: 0 ÷ 2000m s.l.m
Room humidity percentage: 10 ÷ 100% RH
ENGLISH
The technical specications may change without notice
Shelf life: maximum 5 years from the date of manufacture
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ACCESSORIES SUPPLIES
• Complete aspiration jar 4000ml
• Conical tting
• Transparent tubes set 6 mm x 10mm
• Hydrophobic and antibacterial lter
The lter is made of hydrophobic material and blocks the passage of liquids that come into contact with it.
Replace it whenever you suspect that it may be contaminated and/or it becomes wet or discoloured.
Replace the lter every time it is used if the suction pump is used on patients in unknown pathological situations and where an assessment of indirect contamination is not possible.
If, however, the patient’s pathology is known and/or there is no risk of indirect contamination, the lter should
be replaced after every work shift or once a month even if the device is not used.
WARNING: Suction tubes for insertion in the human body purchased separately from the machine
should comply with ISO 10993-1 standards on material biocompatibility.
WARNING: The medical device is provided without a specic suction probe. If this device must be used with a
specic suction probe, the end user is responsible for making sure it complies with the EN 10079-2 regulation.
CLEANING OF ACCESSORIES
To clean the plastic housing of the device wear disposable latex gloves and clean with denaturated alcohol
or hypoclorite solutions.
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 contaminat-
ing substances;
• Disconnect the jar from the device
• Disconnect all tubes from the jar and the protection lter
• Empty and dispose of the Jar according to the laws in force in your country;
• Separate all parts of the cover (overow valve, o-ring);
After disposing of disposable parts and disassembling the jar wash in running cold water and rinse thouroughly.
Then soak in warm water (temperature shall not exceed 60°C). Wash thouroughly and if necessary use a non-abrasive brush to remove incrustations. Rinse in running warm water and dry all parts with a soft cloth (non-abrasive).
The jar and the cover can be autoclaved by placing the parts into the autoclave and running one sterilization
stem cycle at 121°C (1 bar relative pressure) making sure that the jar is positioned upsidedown.
After sterilization and cooling at environment temperature of the parts make sure that these are not damaged.
Assemble the jar as follows:
• Place the overow valve into its seat in the cover (under VACUUM connector)
• Insert oating valve keeping the o-ring towards the opening of the cage
• Place the o-ring into its seat around the cover
• After completing assembling operations always make sue that cover seals perfectly to avoid vacuum leack-
ages or liquid exit
The aspiration tubes can be sterilized on autoclave using a sterilization cycle at 120°C. The conical connector
can be sterilized on autoclave using a sterilization cycle at 121°C.
DO NOT WASH, STERILIZE OR PUT IN AUTOCLAVE THE ANTIBACTERIAL FILTER
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 change it.
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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 nal 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 tting: 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 nal user to verify
whether the tting is suitable for reuse. The component must be replaced if there are visible signs of decay in
the material constituting the said component.
ENGLISH
PERIODICAL MAINTENANCE CHECKS
The TOBI MANUALE SUCTION ASPIRATOR does not need maintenance or lubrication. It is necessary to
check functioning and instrument before every use. Unpack the instrument and always check integrity of
plastic parts, they might have been damaged during previous use. Close the aspirator outlet with your nger.
Press the foot and check vacuum functionally.
Type of fault Cause Remedy
1. No aspiration Jar Cap badly screwed down Unscrewed the cap, then rescrew it cor-
2. No aspiration Lid seal not in its seat Unscrew the cap and insert the seal prop-
3. The oat doesn’t close The oat it’s covered by dirty ma-
4. The oat doesn’t close If the cap has been washed, en-
5. Low suction Foam inside the jar Fill the jar to 1/3 full of ordinary water
6. No aspiration due
to ow leakage of mucus
7. The Vacuum power
on the patient side is
either very low or absent
Faults 1 - 2 - 3 - 4 - 5 -
6 - 7
terial
sure that the oat is not partially
detached
Filter blocked Replace lter
• Protection lter blocked or dam-
aged
• Connection tubes blocked,
kinked or disconnected
• Shut-off valve blocked or dam-
aged
• Pump motor damaged
None of the remedies has
achieved the desired results
rectly
erly in its seat
Unscrewed the cap, leave the and put in
on autoclave
Fit the oat into it’s place
• Replace the lter
• Replace or reconnect the tubes, check
the jar connections
• Empty the jar, or disconnect the tube
from the jar and unblock the shut-off
valve. The unit twill only work in the up-
right position
• Refer to authorised service personnel
Contact the seller or GIMA After-sales Assistance Service
If the overll security system is activated, don’t proceede with the liquid aspiration. If the overll security system doesn’t work there are two cases:
1st case - If the overll security system doesn’t work the aspiration will be stopped by the bacteriological lter
who avoids the liquid penetration inside the device.
2nd case - If both the security system and the bacteriological ltrer do not work, there is the possibility that
liquid has leaked inside the device, in this case return the device to GIMA technical service.
BEFORE EVERY CHECKING OPERATION, IN CASE OF ANOMALIES OR BAD FUNCTIONING,
PLEASE CONTACT GIMA TECHNICAL SERVICE. GIMA DOES NOT GIVE GUARANTEE IF INSTRUMENT,
AFTER THE TECHNICAL SERVICE CHECKING, APPEARS TO BE TAMPERED.
ENGLISH
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INSTRUCTION FOR USE
Connect the short silicon tube, with antibacterial lter, to the suction connector. The other tube, with one end
connected to the lter must be connected with the other end to the jar’s lid connector where has been xed
the red oat. When the 90% of the volume of the jar is reached there is the activation of the security oat (the
oat close the aspiration connector on the jar) to avoid liquid penetration inside the device.
The device must be used on a plan of horizontal operation.
Filter assembling
Make sure the lter is assembled with the arrows on the side of the patient.
WARNING: The inside of the medical device must be regularly checked for the presence of liquids
or other visible contamination (secretions). In the presence of liquids or other visible contamination,
immediately replace the medical device due to the risk of an insufcient vacuum ow rate.
These products have been designed, tested and manufactured exclusively for single patient use and
for a period no longer than 24 hours.
• Connect the long silicon tube to the other jar’s lid connector
•
Connect the other end of the long silicon tube to the probe plastic connector then connect the suction probe to it.
• Unscrew the jar’s lid and ll the jar 1/3 full or ordinary water (this for an easy cleaning operations and an
rapid reaching of the functionality vacuum) the rescrew the lid on the jar correctly.
• Push foot to start suction.
• To extract the accessories and start with cleaning as write in the clean chapter
NEVER USE THE DEVICE WITHOUT JAR AND / OR PROTECTION FILTER
MAKE SURE THAT CHILDREN AND/OR MENTALLY ILL PEOPLE DO NOT USE THE DEVICE WITHOUT
ADULT SURVEILLANCE
SYMBOLS
Caution: read instructions (warnings) carefully Consult instructions for use
Keep in a cool, dry place Keep away from sunlight
Manufacturer Date of manufacture
Product code Lot number
Medical Device complies
with Directive 93/42/EEC
Temperature limit Humidity limit
GIMA WARRANTY TERMS
The Gima 12-month standard B2B warranty applies.
Serial number
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