Contraindications; Technical Characteristics - Gima SUPERVEGA BATTERY Mode D'emploi

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 seri-
ously 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 de-
vice). Suction tubes for insertion in the human body purchased separately from the machine should comply
with ISO 10993-1 standards on material biocompatibility.
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 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.

CONTRAINDICATIONS

- Before using the SUPERVEGA BATTERY SUCTION UNIT, 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.
- SUPERVEGA BATTERY SUCTION UNIT is not suitable for MRI. Do not introduce the device in MRI envi-
ronments.
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.

TECHNICAL CHARACTERISTICS

Model
Typology (MDD 93/42/EEC)
UNI EN ISO 10079-1 Classification
Power Feeding
Current Consumption
Maximum Suction Pressure (without jar)
Minimum Suction Pressure (without jar)
Maximum Suction Flow (without jar)
Insulation Class (when used with the AC/DC adapter)
Insulation Class (when used with an Internal battery)
Weight
Size
Battery Holding Time
Battery Time Charge
Dimension of silicon aspiration tube
Accuracy of Vacuum Indicator
ENGLISH
SUPERVEGA BATTERY SUCTION UNIT
Class IIa Medical device
High Vacuum / High Flow
14V 4A with AC/DC adapter (input: 100-240V~ - 50/60Hz
- 100VA) or Internally powered equipment (Pb Battery
12V 4A)
4.0A
-80kPa (-0.80 Bar)
Less -40kPa (-0.40 bar)
36 l/min
Class II
Internally Powered Equipment
7.98 Kg
320 x 990 (h) x 300 mm
60 minutes
240 minutes
Ø 8x14 mm
± 5%
16