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The tables below provide information on the EMC characteristics (Electromagnetic Compat-

ibility) of this electromedical appliance.

ENGLISH

Guide and declaration of the manufacturer – Electromagnetic Emissions 

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.

Emission test

Conformity Guide to the electromagnetic 

environment

Radiated emissions / 

Conductions CISPR11 

Group 1

The Corsia aerosol uses RF energy only for 

Internal function. Therefore, its RF emissions 

are very low and do not cause any interfer-

ence with other nearby electronic applianc-

es.

Radiated emissions / 

Conductions CISPR11 

Class [B]

The  Corsia  aerosol  is  designed  for  use  in 

any environment, including households and 

those directly connected to the public power 

distribution grid which supplies power to en-

vironments intended for domestic use.

Harmonic currents EN 

61000-3-2

Class [A]

Voltage fluctuations / 

flicker EN 61000-3-3

Compliant

Guide and declaration of the manufacturer – Electromagnetic 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 

Floors  should  be  in  wood, 

cement or ceramics. If floors 

are covered by synthetic ma-

terial,  the  relative  humidity 

should be at least 30%.

Fast transient / burst

EN 61000-4-4

± 2kV power supply

± 1kV signal cables

The appliance 

does not alter 

its status

The power supply should be 

that of a typical commercial 

premise or hospital.

Surge EN 61000-4-5 ± 0.5kV e± 1kV  

differential mode

The appliance 

does not alter 

its status

The power supply should be 

that  of  a  typical  commercial 

premise or hospital.

Voltage dips, short 

outages and 

voltage variations 

EN 61000-4-11

5% 

U

T

 (>95% dip 

in 

U

T

) per 0.5 cycle

40% 

U

T

 (60% dip 

in 

U

T

) per 5 cycles

70% 

U

T

 (30% dip 

in 

U

T

) per 25 cycles

<5% 

U

T

 (>95% dip 

in 

U

T

) per 5 s

--

The power supply should be 

that  of  a  typical  commercial 

premise or hospital.

If the user of the Corsia aer-

osol requires the appliance to 

work continuously, it is rec-

ommended  to  use  it  with  an 

uninterruptible power supply.

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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