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10. At the end of the atomization, set the switch to O and remove the plug from the socket.

11.  Wash the nebulizer and its accessories as specified in the “cleaning” section.

12. Store the accessories into the packaging.

Always use the nebulizer facing upwards in order to prevent any substances and / or the 

medicine from leaking out of the nebulizer during normal use.

In the event of overfilling, empty the ampoule, clean it and repeat the operation. After having 

poured the medicine, screw the top again to the bottom and repeat the operations as speci-

fied in section “instructions for use”.

WARNING: The power cable plug is the separation component from the power network; even 

though the device has the power on / power off switch, the power plug shall be kept accessi-

ble once the appliance is in use in order to allow an additional method of disconnection from 

the power network.

NEVER INHALE IN HORIZONTAL POSITION.

DO NOT TILT THE NEBULIZER OVER 60°.

ELECTROMAGNETIC INTERFERENCE RISKS AND POTEN-

TIAL CORRECTIVE MEASURES

This section contains information on the device compliance with EN 60601-1-2 (2015). Cor-

sia Nebulizer is a medical device which is particularly useful for intensive hospital and clinic 

use. 

CISPR classification: group 1, class B. Corsia Nebulizer is an electro-medical device which 

requires particular precautions regarding electromagnetic compatibility and which must be 

installed and commissioned according to the electro-magnetic compatibility information sup-

plied.

 Avoid using this device close to or overlapped on other appliances because it could not 

work properly. If such use is necessary and inevitable, special precautions shall be adopted 

so that the electromedical device works properly in its standard configuration (for instance, by 

steadily and visually checking the absence of anomalies or malfunctions).

 The use of accessories, transducers and cables other those supplied by the manu-

facturer of the appliance may cause an increase in the electromagnetic emissions and/or a 

reduction in the electromagnetic immunity of the device, thus causing a malfunction.

 Portable and mobile radio communication devices (mobile phones, transceivers, in-

cluding peripheral devices like antennas cables and external antennas, etc.) may affect the 

medical device and should not be used close to (at more than 30cm from any part of the 

device, including cables), adjacent to or overlapped on the medical device. If such use is 

necessary and inevitable, special precautions shall be adopted so that the electromedical 

device  works  properly  in  its  standard  configuration  (for  instance,  by  steadily  and  visually 

checking the absence of anomalies or malfunctions).

ENGLISH

Summary of Contents for 28105

Page 1: ... MANOMÈTRE PROFESSIONELLER CORSIA INHALATOR MIT MANOMETER NEBULIZADOR PROFESIONAL CORSIA CON MANÓMETRO AEROSSOL CORSIA PROFISSIONAL COM MANÓMETRO AEROSOL PROFESIONAL CORSIA CU MANOMETRU PROFESSIONAL MEDICAL PRODUCTS 28105 Gima S p A Via Marconi 1 20060 Gessate MI Italy gima gimaitaly com export gimaitaly com www gimaitaly com Made in Italy 0476 ...

Page 2: ...ore connecting the appliance always check that the electrical data indicated on the label and the type of plug used correspond with the data of the power network to which it is intended to be connected 3 Do not leave the appliance plugged unnecessarily disconnect the plug from the power network if not used 4 Comply with the safety standards for electrical appliances In particular Use only original...

Page 3: ... Do not leave the device unattended in areas accessible to minors and or people with disabilities 10 The patient can come into contact with the medical device through the nebulizer masks mouthpiece and or nosepiece These components comply with the requirements of ISO 10993 1 therefore neither allergic reactions nor skin irritation can occur 11 WARNING Do not alter this appliance without the author...

Page 4: ...orsia POWER SUPPLY 230V 50Hz ABSORBED POWER 170 VA FUSE F 1 x 1 6A L 250V MAXIMUM PRESSURE 250 kPa 2 5 Bar MAXIMUM FLOW in the compressor 16 l min OPERATING PRESSURE 130 kPa 1 30 Bar OPERATIONAL FLOW 5 2 l min a 130 kPa ATOMIZATION 0 50 ml min with 4ml solution NaCl 0 9 MMAD measured in accordance with EN 13544 1 3 25 GSD 3 45 WEIGHT 2 20 Kg SIZE 255 x 190 x 165 h mm MAXIMUM NOISE LEVEL 57 dB A FU...

Page 5: ... any part that requires maintenance and or lubrication Nonetheless it is necessary to carry out some checks to verify the function and security of the appliance before each use Before using the device carry out disinfection as described in the CLEANING ACCESSORIES section Remove the appliance from the box and always check that there is no visible damage particular attention should be given to any ...

Page 6: ...upper part of the nebulizer anticlockwise 3 Disconnect the internal pisper at the bottom of the nebulizer with finger force Type of defect Cause Corrective action 1 The device doesn t work The plug may be mis placed in the wall socket Thermal protector may be on the device has been working beyond its limits and or near heat sources Make sure the plug is properly placed in the wall socket Make sure...

Page 7: ...rmed only if the components have been previously cleaned see cleaning section For the washing procedure the following operations shall be carried out Fill a container of suitable size to hold every individual component with drinking water and disinfectant hypochlorite solution easily available in pharmacies by complying with the proportions indicated on the disinfectant packaging The immersion tim...

Page 8: ...n 1500 operating hours or 5 years in accordance with the standard test and operating conditions Expected shelf life up to 5 years from the date of manufacture INSTRUCTIONS FOR USE Check the device before each use in order to detect malfunctions and or damage due to transport and or storage When inhaling the patient must sit upright in a relaxed position at a table and not on an armchair to avoid c...

Page 9: ...1 class B Corsia Nebulizer is an electro medical device which requires particular precautions regarding electromagnetic compatibility and which must be installed and commissioned according to the electro magnetic compatibility information sup plied Avoid using this device close to or overlapped on other appliances because it could not work properly If such use is necessary and inevitable special p...

Page 10: ...etic Immunity The Corsia aerosol can be used in the following electromagnetic environment The Cus tomer and or the user of the Corsia aerosol shall make sure that the appliance is used in such environment Immunity test Standard of proof Level of conformity Guide to the electromag netic environment Electrostatic discharge ESD EN 61000 4 2 8kV contact 15kV air The appliance does not alter its status...

Page 11: ...d separation distanc es d 3 5 V1 P d 12 E1 P 80MHz to 800MHz d 23 E1 P 800MHz to 2 7GHz P is the maximum rated output power of the transmitter in Watt W according to the manufacturer of the transmitter and d is the recommended separation distance calculated in meters m The field strengths from fixed RF trans mitters as established in an electro magnetic survey of the sitea could be less than the l...

Page 12: ...ment in which the RF radiated interferences are kept under control The customer or the user of the Corsia appliance can contribute to prevent electromagnetic interferences by ensuring a minimum distance between portable and mobile RF communication devices transmitters and the Corsia appliance as recommended below according to the maximum rated output power of the radio communication devices Maximu...

Page 13: ...RRANTY TERMS The Gima 12 month standard B2B warranty applies ENGLISH Caution read instructions warnings carefully Follow instructions for use Keep in a cool dry place Keep away from sunlight Manufacturer Date of manufacture Product code Lot number Medical Device complies with Directive 93 42 EEC Serial number WEEE disposal Type B applied part Class II applied Temperature limit Humidity limit Atmos...

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