Gima TOBI CLINIC Users Guide

ASPIRATORE CHIRURGICO TOBI CLINIC
TOBI CLINIC SUCTION ASPIRATOR
ASPIRATEUR TOBI CLINIC
CHIRURGISCHER ABSAUGER TOBI CLINIC
ASPIRADOR QUIRÚRGICO TOBI CLINIC

M28214-M-Rev.6-01.21

28214 - 28215 - 28216 - 28231

Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
[e-mail] - [e-mail]
www.gimaitaly.com
Made in Italy

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TOBI CLINIC is a surgical aspirator power-fed at 230V ~ / 50Hz, to be used for suctioning body liquids
(such as mucus, phlegm and blood) provided with 4 antistatic wheels, two of which with braking device,
and a pulling handle.
This equipment is designed for easy transport and continuous utilization.
Thanks to these characteristics and to its functions, this device is particularly suitable for utilization in
hospital wards and operation theatres both for suctioning body liquids and for gynaecological and der­matological (liposuction) applications.
It’s provided with a plastic body, with thermal and electrical isolation in compliance with European safety

standards, two complete suction tanks in polycarbonate suitable for sterilization, and a oat valve, besi­des being tted with a suction regulator and a vacuum gauge on the front panel. Available under request

with differents versions for applications and use (version with remote control, version with 4 litre jars,

version with ow direction regulator).

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• Read instruction manual carefully before use

• Only highly qualied staff use reserved

• The instrument must not be disassembled. for a technical service always contact GIMA

• Keep off the reach of children or not capable people without supervision

• Full containers must be handled with great care during transfer to the disposal areas, following

the local procedures and regulations

IMPORTANT SAFETY RULES:

1. Check the condition of the unit before each use. The surface of the unit should carefully inspected for

visual damage. Check the mains cable and do not connect to power if damage is apparent;

2. Before connecting the appliance always check that the electric data indicated on the data label and

the type of plug used, correspond to those of the mains electricity to witch it’s to be connected;

3. Respect the safety regulations indicated for electrical appliances and particularly:

• Use original components and accessories provided by the manufacturer to guarantee the highest

efciency and safety of the device;

• The device can be used only with the bacteriological lter;

• Never immerge the appliance into water;

• Position the device on stable and at surfaces in a way that the air inlets on the back aren’t obstructed;

• To avoid incidents, do not place the aspirator on 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 device, do not connect the plug to the
electrical socket. Do not attempt to make the device work before it has been thoroughly checked by

qualied personnel and/or the GIMA technical service department.

• Don’t use in the presence of inammable substances such as anaesthetic, oxygen or nitrous oxide;

• Don’t touch the device with wet hands and always prevent the appliance coming into contact with

liquids;

• Don’t leave the appliance connected to the power supply socket when not in use;

• Don’t pull the power supply cable to disconnect the plug remove the plug from the mains socket

correctly;

• Store and use the device in places protected against the weather and far from any sources of heat.

After each use, it is recommended to store the device in its own box away from dust and sunlight.

• In general, it is inadvisable to use single or multiple adapters and/or extensions. Should their use be
necessary, you must use ones that are in compliance with safety regulations, however, taking care not
to exceed the maximum power supply tolerated, which is indicated on the adapters and extensions.

4. 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;

5. Use only for the purpose intended. Don’t use for anything other than the use dened by the manu-
facturer. The manufacturer will not be responsible for damage due to improper use or connection to
an electrical system not complying with current regulation.

6. Instrument and accessory discharging must be done according to current regulations in the country
of use.

7. WARNING: Do not change this equipment without the permission of the manufacturer. None of elec-

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tric or mechanical parts have been designed to be repaired by customers or end-users. Don’t open
the device, do not mishandle the electric / mechanical parts. Always contact technical assistance

8. 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;

9. The medical device is in contact with the patient by means of a disposable probe (not supplied with

the device). If this device must be used with a specic suction probe, the end user is responsible for
making sure it complies with the ISO 10993-1 rule;

10. The product and its parts are biocompatible in accordance with the requirements of regulation EN

60601-1;

11. Operation of the device is very simple and therefore no further explanations are required other than
those indicated in the following user manual.

12. The medical device requires special precautions regarding electromagnetic compatibility and must be
installed and used in accordance with the information provided with the accompanying documents:
the TOBI CLINIC device must be installed and used away from mobile

The Manufacturer cannot be held liable for accidental or indirect damages should the device

be modied, repaired without authorization or should any of its component be damaged due to

accident or misuse.
Any minimal modication / repair on the device voids the warranty and does not guarantee the com­pliance with the technical requirements provided by the MDD 93/42/EEC Directive and its normatives.

CONTRAINDICATIONS:

• Before using the TOBI CLINIC, consult the instructions for use: failure to read all the instructions in this

manual can be harmful for the patient.

• The device cannot be used to drain chest uids;

• The device must not be used for suction of explosive, corrosive or easily ammable liquids.

• TOBI CLINIC is not suitable for MRI. Do not introduce the device in MRI environments.

TECHNICAL CHARACTERISTICS:

TYPOLOGY (MDD 93/42/EEC) Class IIa Medical Decice

MODEL

UNI EN ISO 10079-1 HIGH VACUUM / HIGH FLOW

POWER FEEDING 230V ~ / 50Hz

POWER CONSUMPTION 230 VA

FUSE F 1 x 4A L 250V

MAXIMUM SUCTION PRESSURE (without jar) -90kPa / -0.90 Bar / -675mmHg

MAXIMUM SUCTION FLOW (without jar) 60 l/min

WEIGHT 13 Kg

SIZE 600 x 460 x 420 mm

DUTY CYCLE Non – Stop Operated

SICILICONE TUBE SIZE Ø 8x14 mm

ACCURANCY OF VACUUM INDICATOR ± 5%

WORKING CONDITION

CONSERVATION CONDITION AND TRASPORT

TOBICLINIC

Room temperature: 5 ÷ 35°C
Room humidity percentage: 30 ÷ 75% RH
Atmospheric pressure: 800 ÷ 1060 hPa
Altitude: 0 ÷ 2000m s.l.m.

Room temperature: - 40°C ÷ 70°C
Room humidity percentage: 10 ÷ 100% RH
Atmospheric pressure: 500 ÷ 1060 hPa

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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 abra­sive 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 AND HYDROFOBIC FILTER

• FOOTSWITCH CONTROL (for versions equipped with footswitch control)

• EUROPEAN POWER SUPPLY CORD

Replacing the antibacterial filter:

The lter is made of hydrophobic material that stops the passage of liquids into the same lter.
If you suspect the lter may have been contaminated and/or got wet or discoloured, always remove and
replace the lter.

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 lter

is not designed for decontamination, disassembly and/or sterilization. If you suspect the lter may have
been contaminated and/or got wet or discoloured, always remove and replace the lter. 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 lter 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 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 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 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.

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 specic suction probe. If this device must be used with a specic suction probe, the end user is

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

CLEANING ACCESSORIES AND INTERNAL PARTS

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 con-

taminating 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 (overow device, washer).