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9. The medical device is in contact with the patient by means of a disposable probe (not supplied with
the device). If this device must be used with a specific suction probe, the end user is responsible for
making sure it complies with the ISO 10993-1 rule;
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 medical device requires special precautions regarding electromagnetic compatibility and must be
installed and used in accordance with the information provided with the accompanying documents:
the TOBI HOSPITAL device must be installed and used away from mobile.
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
Directive and its normatives.)
Under certain failure conditions the temperature of the casing may become hot and there may be
a risk of burns if you touch those parts. In any case, the temperatures do not exceed the limit of
105°C (rif. Interpretation Sheet IEC 60601-1 - ISH3 May 2013).
CONTRAINDICATIONS:
•
Before using the TOBI HOSPITAL, 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.
•
TOBI HOSPITAL is not suitable for MRI. Do not introduce the device in MRI environments.
TECHNICAL CHARACTERISTICS:
TYPOLOGY (MDD 93/42/EEC)
Class IIa Medical Decice
MODEL
TOBI HOSPITAL
UNI EN ISO 10079-1
HIGH VACUUM / HIGH FLOW
POWER FEEDING
230V ~ / 50Hz
POWER CONSUMPTION
385 VA
FUSE
F 1 x 4A L 250V
MAXIMUM SUCTION PRESSURE (without jar)
-90kPa / -0.90 Bar / -675mmHg
MAXIMUM SUCTION FLOW (without jar)
90 l/min
WEIGHT
20 Kg
SIZE
650 x 550 (h) x 450mm
DUTY CYCLE
Non – Stop Operated
SICILICONE TUBE SIZE
Ø 8x14 mm
ACCURANCY OF VACUUM INDICATOR
± 5%
WORKING CONDITION
Room temperature: 5 ÷ 35°C
Room humidity percentage: 30 ÷ 75% RH
Atmospheric pressure: 800 ÷ 1060 hPa
Altitude: 0 ÷ 2000m s.l.m.
CONSERVATION CONDITION AND TRASPORT
Room temperature: - 40°C ÷ 70°C
Room humidity percentage: 10 ÷ 100% RH
Atmospheric pressure: 500 ÷ 1060 hPa
