GB
18
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 seriously 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 accident 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 subsequent changes) and its
normatives.
IMPORTANT INFORMATION FOR CORRECT DISPOSAL OF THE PRODUCT IN ACCORDANCE WITH EC
DIRECTIVE 2012/19/UE-RAEE:
The symbol on the device indicates the separated collection of electric and
electronic equipment. At the end of life of the device, don’t dispose it as mixed solid municipal waste, but
dispose it referring to a specific collection centre located in your area or returring it to the distributor, when
buying a new device of the sample type to be used with the same functions. This procedure of separated
collection of electric and electronic devices is carried out forecasting a European environmental policy aiming
at safeguarding protecting and improving environment quality, as well as avoiding potential effects on human
health due to the presence of hazardous substances in such equipment or to an improper use of the same or of
parts of the same. Caution: The wrong disposal of electric and electronic equipment may involve sanctions.
TECHNICAL CHARACTERISTICS
Model
SUPERVEGA EVO BATTERY ASPIRATOR
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 mod. UE60-140429SPA1
of FUHUA (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
Weight
2.70 Kg
Insulation Class (when used with AC / DC adapter or when
connected to a car cigarette lighter cable))
Class II
Insulation Class (when used with an Internal battery)
Internally Powered Equipment
Size
350 x 210 x 180 mm
Battery Holding Time
70 minutes
Battery Time Charge
360 minutes
Working Condition
Room temperature:
0 ÷ 40 °C
Room humidity percentage:
0 ÷ 85% RH
Atmospheric pressure:
800 ÷ 1060 hPa
Altitude:
0 ÷ 2000m s.l.m.
Conservation condition and Transport
Room temperature (≤ 1 mounth): :
- 20 ÷ 45 °C
Temperatura ambiente (≤ 3 mounth): - 20°C ÷ 35°C
Temperatura ambiente (≤ 1 year): 0°C ÷ 25°C
Room humidity percentage:
0 ÷ 85% RH
Atmospheric pressure:
500 ÷ 1060 hPa
Please note that if the device is used at an altitude higher than 2,500 m asl, the yield intended as suction flow may vary sensitively
due to the decrease in atmospheric pressure
.
