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ENGLISH
PER VEGA BATTERY SUCTION UNIT device must be installed and used away from mobile and portable
RF communication 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 country 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 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
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 (not supplied with the
device).
Suction tubes for insertion in the human body purchased separately from the machine should comply with
ISO 10993-1 standards on material biocompatibility.
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. The lead battery integrated in the device is not to be considered as an ordinary domestic waste. Such a
component must be disposed of in a specific collection centre in order to be recycled.
14. 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.
15. Do not leave the device unattended in places accessible to children and/or persons not in full possession
of mental faculties as 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 acci-
dent or misuse.
Any minimal modification / repair on the device voids the warranty and does not guarantee the com-
pliance with the technical requirements provided by the MDD 93/42/EEC (and subsequent changes)
and its normatives.
CONTRAINDICATIONS
- Before using the ASPIRATOR, 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.
- ASPIRATOR is not suitable for MRI. Do not introduce the device in MRI environments.
TECHNICAL CHARACTERISTICS
Model
SUPERVEGA BATTERY 230/12V
Typology (MDD 93/42/EEC)
Class IIa Medical device
UNI EN ISO 10079-1 Classification
HIGH VACUUM / LOW FLOW
Power Feeding
14V
4A with AC/DC adapter (input: 100-240V~ - 50/60Hz
- 100VA) or Internally powered equipment (Pb Battery
12V
4A) or with cigarette lighter adapter (12V
4A)
Maximum Suction Pressure (without jar)
-75kPa (- 0.75 bar)
Minimum Suction Pressure (without jar)
Less -25kPa (-0.25 bar)
Maximum Suction Flow (without jar)
16 l /min
Weight
3.50 Kg
Insulation Class (when used with the AC/DC adapter) Class II
