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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

Level set out by

EN 60601-1-2

Level of 

conformity

Electromagnetic Environment - 

Guide

Conducted 

immunities

EN 61000-4-6

Radiated 

immunity

EN 61000-4-3

3Vrms 150kHz 

to 80MHz 

(for non-life-

supporting 

appliances)

10 V/m 80MHz 

to 2.7GHz 

(for non-life-equip-

ment appliances)

V

1

 = 

3 V rms

E

1

 = 

10 V / m

Portable and mobile RF communication 

devices should be used no closer than 

the separation distance from any part of 

the Corsia device, including cables, cal-

culated from the equation applicable to 

the frequency of the transmitter.

Recommended separation distanc-

es

d=

 [

3.5

 / 

V

1

√P

d=

 [

12

 / 

E

1

√P

   80MHz to 800MHz

d=

 [

23

 / 

E

1

√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 site

a

, could be 

less than the level of conformity of each 

frequency range

b

It is possible to check the 

interference  close  to  the 

appliances  labelled  with 

the following symbol:

Note 1: At 80 MHz and 800 MHz the highest frequency range applies.

Note 2: These guidelines could not apply to all conditions. The electromagnetic propaga-

tion is affected by the absorption and reflection of premises, objects and individuals.

ENGLISH

Network frequency 

magnetic field 

EN 61000-4-8

30 A/m

The appliance 

does not alter 

its status

The power supply should be 

that  of  a  typical  commercial 

premise or hospital.

Note: 

U

T

 is the value of the supply voltage

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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