16
ENGLISH
wet (send it immediately to an authorized service center or technical service).
4. For repairs, exclusively contact Gima technical service or a technical assistance centre authorised by the
manufacturer and only original spare parts may be used. Failure to comply with the above may compro-
mise the safety of the device.
5. This device must only be used for its intended use and as described in this manual. Any use other
than that for which the device is intended must be considered improper and therefore dangerous; the man-
ufacturer cannot be held liable for damages caused by improper, erroneous and/or unreasonable use or if
the device is used in electrical systems which do not comply with current safety standards.
6. The medical device requires special precautions regarding electromagnetic compatibility and must be in-
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 standard.
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.
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 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 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
Modell
SUPERVEGA EVO
Typology (MDD 93/42/EEC)
Class IIa Medical device
UNI EN ISO 10079-1 CLASSIFICATION
High vacuum / High flow
Power Feeding
14V
4A with AC/DC adapter (input: 100-240V~
- 50/60Hz - 100VA) or Internally powered equipment
(Li-Ion battery 14.8V
5.2A) or with cigarette
lighter adapter (12V
4A)
Maximum Suction Pressure (adjustable)
-75kPa (-0.75 Bar)
Minimum Suction Pressure (adjustable)
-15kPa (-0.15 bar)
Maximum Suction Flow
26 l/min
Insulation Class (when used with the SUPPORT BRACKET)
Class II
Insulation Class (when used with an Internal battery)
Internally Powered Equipment
Weight
2.70 Kg
Size
350 x 210 x 180mm
Battery Holding Time
70 minuti
Battery Time Charge
360 minutes
