Technical Characteristics - Gima 28200 Manual Del Usuario

8. Using the device in environmental conditions different than those indicated in this manual may harm seri-
ously 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
HOSPI PLUS SUCTION ASPIRATOR device must be installed and used away from mobile and portable
RF communication devices (mobile phones, transceivers, etc.) that may interference with the said device.
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 (ref.
Interpretation Sheet IEC 60601-1 / ISH May 2013).
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.
CONTRAINDICATIONS
•
Before using the HOSPI PLUS SUCTION ASPIRATOR, 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.
•
HOSPI PLUS SUCTION ASPIRATOR 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
HOSPI PLUS SUCTION ASPIRATOR
HIGH VACUUM / HIGH FLOW
230V ~ / 50Hz
385 VA
F 1 x 4A L 250V
-90kPa / -0.90 Bar / -675mmHg
90 l/min
20 Kg
460 x 850 (h) 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
16