Contraindications; Technical Characteristics - Gima SUPERVEGA EVO Bedienungsanleitung

stalled and used according to the information provided with the accompanying documents: the device must
be installed and used away from mobile and portable RF communication devices (cell phones, transceiv-
ers, etc.) that could affect the device itself.
7. WARNING: Do not modify this device without the manufacturer's authorisation. No electrical and/or me-
chanical part contained in the device has been designed to be repaired by the user. Failure to comply with
the above may compromise the safety of the device.
8. The use of the device in environmental conditions other than those indicated in this manual can seriously
affect its safety and technical parameters.
9. The medical device comes into contact with the patient through the single-use probe. Any suction cannulas
that enter the human body, purchased separately from the machine, must comply with the requirements of
ISO 10993-1.
10. The product and its parts are biocompatible in accordance with the requirements of the EN 60601-1 stand-
ard.
11. The operation of the device is very simple and therefore no further measures are required other than those
indicated in the following user manual.
12. The lithium-ion battery contained within the medical device should not be considered normal household
waste. Dispose of this component at a suitable collection point for its recycling.
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 SUPERVEGA EVO 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 EVO SUCTION UNIT is not suitable for MRI. Do not introduce the device in MRI environ-
ments

TECHNICAL CHARACTERISTICS

Modell
Typology (MDD 93/42/EEC)
UNI EN ISO 10079-1 CLASSIFICATION
Power Feeding
Maximum Suction Pressure (adjustable)
Minimum Suction Pressure (adjustable)
Maximum Suction Flow
Insulation Class (when used with the SUPPORT BRACKET)
Insulation Class (when used with an Internal battery)
Weight
Size
Battery Holding Time
Battery Time Charge
Battery life
Working Condition
ENGLISH
SUPERVEGA EVO
Class IIa Medical device
High vacuum / High flow
5,2 A - 14,8 V by internal Li-Ion battery
4A - 12V 4A) by ambulance adapter model
-75kPa (-0.75 Bar)
-15kPa (-0.15 bar)
26 l/min
Class II
Internally Powered Equipment
2.70 Kg
350 x 190 x 150mm
70 minuti
360 minutes
300 charging cycles
Room temperature: 0 ÷ 40°C
Room humidity percentage: 0 ÷ 85% RH
Atmospheric pressure: 800 ÷ 1060 hPa
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