Technical Characteristics - Gima TOBI CLINIC Manual Del Usuario

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tric 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
8. 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;
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 CLINIC 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 com-
pliance with the technical requirements provided by the MDD 93/42/EEC Directive and its normatives.
CONTRAINDICATIONS:
•
Before using the TOBI CLINIC, 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 CLINIC is not suitable for MRI. Do not introduce the device in MRI environments.

TECHNICAL CHARACTERISTICS:

TYPOLOGY (MDD 93/42/EEC)
MODEL
UNI EN ISO 10079-1
POWER FEEDING
POWER CONSUMPTION
FUSE
MAXIMUM SUCTION PRESSURE (without jar)
MAXIMUM SUCTION FLOW (without jar)
WEIGHT
SIZE
DUTY CYCLE
SICILICONE TUBE SIZE
ACCURANCY OF VACUUM INDICATOR
WORKING CONDITION
CONSERVATION CONDITION AND TRASPORT
eNgLIsh
Class IIa Medical Decice
TOBI CLINIC
HIGH VACUUM / HIGH FLOW
230V ~ / 50Hz
230 VA
F 1 x 4A L 250V
-90kPa / -0.90 Bar / -675mmHg
60 l/min
13 Kg
600 x 460 x 420 mm
Non – Stop Operated
Ø 8x14 mm
± 5%
Room temperature: 5 ÷ 35°C
Room humidity percentage: 30 ÷ 75% RH
Atmospheric pressure: 800 ÷ 1060 hPa
Altitude: 0 ÷ 2000m s.l.m.
Room temperature: - 40°C ÷ 70°C
Room humidity percentage: 10 ÷ 100% RH
Atmospheric pressure: 500 ÷ 1060 hPa