Gima 28222 Mode D'emploi page 14

devices (mobile phones, transceivers, etc.) that may interference with the said device.
7. Instrument and accessory discharging must be done according to current regulations in the coun-
try of use.
8. WARNING: Do not change this equipment without the permission of the manufacturer GIMA S.p.A. None
of electric or mechanical parts has 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
9. Using the device in environmental conditions different than those indicated in this manual may harm seri-
ously the safety and the technical characteristics of the same.
10. The medical device is in contact with the patient by means of a disposable probe (supplied with the device)
furnished with the relative CE compliance certification according to the requirements of regulation ISO
10993-1: thus, no allergic reactions and skin irritations may occur.
11. The product and its parts are biocompatible in accordance with the requirements of regulation EN 60601-1.
12. Operation of the device is very simple and therefore no further explanations are required other than those
indicated in the following user manual.
13. Use in Home-Care: Keep all accessories of the device out of reach of children under 36 months of age
since they contain small parts that may be swallowed.
14. Do not leave the device unattended in places accessible to children and/or persons not in full possession
of mental facultiesas they may strangle themselves with the patient's tube and/or the power cable.
The manufacturer cannot be held liable for accidental or indirect damages should the device
be modified, repaired without authorization or should any of its component be damaged due to ac-
cident or misuse. Any minimal modification / 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 sub-
sequent changes) and its normatives.
CONTRAINDICATIONS
- Before using the TOBI, 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 fluids;
- The device must not be used for suction of explosive, corrosive or easily flammable liquids.
- TOBI is not suitable for MRI. Do not introduce the device in MRI environments.
TECHNICAL CHARACTERISTICS
Model
Typology (MDD 93/42/EEC)
Classification UNI EN ISO 10079-1
Main Voltage
Power consuption
Fuse
Maximum suction aspiration (without jar)
Maximum flow (without jar)
Weight
Dimension
Functioning
Accuracy of Vacuum Indicator
ENGLISH
TOBI SUCTION ASPIRATOR
Medical device Class IIa
High Vacuum / Low Flow
230 V ~ / 50 Hz
184 VA
F 1 x 1.6A L 250 V
-75kPa (- 0.75bar)
Regolable from -75kPa (-0.75 bar) to -10kPa (-0.10 bar)
16 l/min
2.5 Kg
370 x 220 x 210 mm
NON-STOP OPERATED
± 5%
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