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safety standards, paying attention not to exceed the maximum power limits indicated 

on the adapters and on the extension cables. 

5.  For repair works contact only Gima’s technical service or a technical center authorized by 

the manufacturer. The device requires the use of original spare parts. Failure to comply 

with the above may compromise the safety of the appliance.

6.  This appliance shall be solely intended for the use which was designed for and 

according to the instructions of this manual. Therefore, it shall be used as aerosol 

therapy system. Any other use is improper and therefore hazardous; the manufacturer 

shall not be deemed responsible for damage caused by an improper use or if the appliance 

is used in electrical installations that do not comply with the safety regulations in force. 

7.  The medical device requires specific precautions in terms of electromagnetic compatibil-

ity and shall be installed and used according to the instructions provided along with the 

accompanying documents: the Corsia device shall be installed and used away from port-

able and mobile RF communication devices (mobile phones, transceivers, etc.) which 

may affect the appliance.

8.  Some components of the appliance are of small size and might be swallowed by children; 

keep the device out of reach of children. 

9.  Keep the accessories out of reach of children. Children and dependents shall always use 

the medical device under the close supervision of an adult with full mental capacity. Keep 

the ampoule out of reach of children under 36 months as it contains small parts which be 

may swallowed.

 

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 authorization of Gima S.p.A..

 

No electrical and / or mechanical part which the device consists of has been designed to 

be repaired by the user.

 

Failure to do so can compromise the safety of the appliance.

12. The use of the medical device in environmental conditions other than those illustrated in 

this manual may jeopardize the safety and the parameters of the appliance.

13. The materials used for the contact with drugs are thermoplastic polymers with high chem-

ical stability and resistance.

 

Such  materials  have  been  tested  with  commonly-used  medications  (Salbutamol,  Be-

clomethasone Dipropionate, Acetylcysteine, Budesonide, Ambroxol) and no interaction 

has been reported. Nonetheless, given the variety and the ongoing evolution of the med-

icines used, potential interactions cannot be ruled out. Therefore, it is recommended to:  

-  Use up the drug as quickly as possible after its opening.

-  Always avoid prolonged contact of the drug with the container. Clean the container 

immediately after its use. 

-  In the event of anomalous situations (e.g. softening or cracks) of the container, do not 

introduce any solution and do not inhale. Contact the technical service, specifying the 

methods of use and the type of drug used.

14. Remember to:

-  use this appliance only with medicines prescribed by your doctor;

-  perform the treatment by using only the accessory instructed by your doctor according 

to the disease.

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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