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Inhalator nebulizator pneumatyczny FLAEM NUOVA Respir Air 0.23 ml/min

Instrukcja obsługi Inhalator nebulizator pneumatyczny FLAEM NUOVA Respir Air 0.23 ml/min

Powrót
Assembly diagram - Schéma de montage - Verbindingsschema
Anschlussschema - Schemat połączeń dla nomenklatury - схеме соединения
ENGLISH
pg. 2
FRANÇAIS
Pag. 7
NEDERLANDS
Pag. 12
DEUTSCH
Pag. 17
POLSKI
PÁG. 22
РУССКИЙ
CTp. 27
INSTRUCTIONS FOR USE MANUAL - Aerosol therapy unit for frequent use
MODE D’EMPLOI - Appareil aérosol pour utilisation fréquente
GEBRUIKSAANWIJZING - Aerosol voor regelmatig gebruik
GEBRAUCHSANWEISUNG - Aerosol-Inhalationsgerät für den häufigen Gebrauch
INSTRUKCJA OBSŁUGI - Aerozol urządzenie do częstego stosowania terapii
-
Аппарат для аэрозольтерапии, для частого использования
PL
D
A
B
C
A1
A2
C2
C3
C4
C2.1
A5
C1
A4
C1.4
C1.3
C1.2
C1.1
C1
A3
A6
2
Respirair
Mod.: P0611EM F1000
Aerosol Therapy Device
Congratulations on your purchase and thank you for your condence in us.
Our goal is to fully satisfy our customers by oering them
cutting-edge products for the treatment of respiratory tract ailments.
Please read these instructions carefully and keep them handy for future reference. Use
this device only as described in this manual. This is a medical device for home use for the
nebulization and administration of medication prescribed or suggested by your doctor.
Please visit www.aem.it to see our entire range of Flaem products
THIS DEVICE COMES EQUIPPED WITH:
A - Aerosol Device (main unit)
A1 - Switch
A2 - Air outlet port
A3 - Air lter
A4 - Nebulizer port
A5 - Carrying handle
A6 - Power cord
B - Connection tube
(main unit / nebulizer)
C - Accessories
C1 - RF7 Dual Speed Plus Nebulizer
C1.1 - Bottom piece
C1.2 - Nozzle
C1.3 - Top piece
C1.4 - Speed selector with valve system
C2 - Mouthpiece with valve
C2.1 - Exhalation valve
C3 - Pediatric mask
C4 - Adult mask
D - Convenient, roomy carrying bag
IMPOrTAnT SAFEgUArDS
• Beforeusingtheunitforthersttime,andperiodicallythroughoutitslife,checkthepowersupply
cordforanydamage;ifyoudetectanydamage,donotplugitin.Taketheapplianceimmediatelyto
an authorised service centre or your dealer.
• Theaveragelifespanofaccessoriesis 1year;however,werecommendyoureplacethenebulizer
every6monthsinintensiveuse(orearlier,ifthenebulizerisblocked)toalwaysensuremaximum
therapeutic eect.
• Childrenanddisabledpersonsshouldalwaysusetheunitunderstrictsupervisionofanadultwho
has read this manual.
•Severalpartsofthedevicearesmallenoughtobeswallowedbychildren;thereforekeepthedevice
out of reach of children.
• Donotusethetubesandthecordsofthedeviceforpurposesotherthanthosespeciedasthey
may cause strangulation hazard; utmost attention must be paid to children and persons with special
needs;usually,suchpersonsarenotcapableofassessingthehazardcorrectly.
•Theunitshouldnotbeusedinthepresenceofanaestheticmixtureinammablewithair,oxygenor
nitrous oxide.
• Keepthecordawayfromheatedsurfaces.
• Keepthe powersupply cord awayfromanimals (for example rodents) as they maydamagethe
insulation of the power supply cord.
• Donothandletheunitwithwethands.Donotusethedeviceinhumidenvironments(e.g.while
takingabathorshower).Donotimmersethedeviceinwater;shouldthisaccidentallyoccur,unplug
the device immediately. Do not remove or touch the device immersed in water before pulling out
the plug. Take the device immediately to an authorized service center or to your local dealer.
• Onlyusethedeviceindust-freeenvironments;otherwise,therapymaybecompromised.
•Thecasingofthisunitisnotprotectedagainstthepenetrationofliquids.Donotwashthedevice
underrunningwaterorsubmergeinwater.Keepawayfromsplashingwaterorotherliquids.
•Donotexposethedevicetohightemperatures.
•Donotputthedevicenearheatsources,directsunlight,orinhotenvironments.
•Donotobstructorinsertanyobjectsinthelterorinitshousinginthedevice.
•Donotobstructtheairventsplacedonbothsidesoftheunit.
ENGLISH
3
OPErATIng InSTrUCTIOnS
Before each use, clean hands thoroughly and clean the device as described in the section on
“CLEAnIng, SAnITIZATIOn AnD DISInFECTIOn”. During use, it is advisable to protect yourself
from any dripping. It is recommended that each person use their own nebulizer cup and
accessories to prevent risk of infection due to contamination.
1.Plugthepowercord(A6)intoapowersocketcorrespondingtothevoltageoftheunit.Thismustbe
positioned so that it is not dicult to make the disconnection from the mains.
2.Openthenebulizerbyturningthetoppiece(C1.3)anticlockwise.
3.Pourthemedicineprescribedbyyourphysicianinthebottompiece(C1.1).Closethenebulizerby
turningthetoppiece(C1.3)clockwise.
4. Connect accessories as indicated in the “Connection diagram” on the cover.
5.Sit comfortably holding the nebuliser in your hand, place the mouthpiece onto your mouth or
alternatively use the nose piece
or mask. Should you opt for the mask accessory, place it on
your face as shown in the picture (with or without using the
elasticatedstrap).
6.Turnonthedevice using the switch(A1)and then breathein
and exhale deeply.
7.Whenthetreatmentisnished,shutothedeviceandunplug
the power cord.
WARNING: If after the therapy session moisture accumulates in
thetube(B),removethetubefromthenebulizeranddryitusing
the device’s compressor fan; this operation will prevent mold from
forming inside the tube.
• Duringuse,alwaysplacetheunitonarmsurfaceclearofobstacles.
• Checkthatthereisnomaterialobstructingtheairventsbeforeeachuse.
• Donotplaceanyobjectsinsidetheairvents.
•Repairsmustbeperformedbyauthorizedpersonnelonly.Anyunauthorizedrepairswillvoidthe
warranty and may pose a safety hazard for the user.
WARNING:Donotmodifythisequipmentwithoutauthorizationofthemanufacturer
• Theaveragedurationprovidedforcompressorrangesis:F400:400hours,F700:700hours,F1000:
1000hours,F2000:2000hours.
•The Manufacturer, the Retailer and the Importer are responsible for the safety, reliability and
performanceofthedeviceonlyif:a)thedeviceisusedinaccordancewiththeoperatinginstructions
b)theelectricalsystemofthepremiseswherethedeviceisusedisincompliancewithcurrentlaws.
•Interactions:Thematerialsusedthatcomeintocontactwithmedicationshavebeentestedwitha
widerangeofmedications.However,duetothevarietyandcontinuousevolutionofmedication,
the possibility of a chemical interaction cannot be excluded. We recommend that once the
medication has been opened you should use it as soon as possible and avoid prolonged contact of
the medication with the nebulizer.
• Themanufacturershouldbecontactedforreportingproblemsand/orunexpectedeventsrelatedto
device operation.
HOW TO USE THE “rF7 DUAL SPEED PLUS” nEBULIZEr WITH SPEED SELECTOr AnD
VALVE SySTEM
Professionalandfast,thisdeviceissuitableforadministeringalltypesofmedications,
including more expensive ones, even in patients with chronic diseases. The
geometry of the internal lines of the RF7 Dual Speed Plus nebulizer ensures the ideal
granulometry for active treatment all the way down to the lower respiratory tract.
To speed up the inhalation therapy, move the speed selector button (C1.4) by
pressing on MAX with your nger.
Foramoreeectiveinhalationtherapy,pressontheoppositesideofthewordMax
locatedon the speed selector button(C1.4);this allows youtoinhale an optimal
amount of the medication and reduces dispersion of the medication into the
surrounding environment to a minimum thanks to the valve system provided in the
nebulizer,mouthpiece,andmask.
MAX
4
SOFTTOUCH MASk
SoftTouch masks have an outer edge made of soft
biocompatible material that ensures excellent adherence to
theface,andisalsoequippedwithaninnovative Dispersion
Limiting Device. These distinctive elements that distinguish
it allow greater sedimentation of medication in the patient
and also limit dispersion.
During the inspiratory phase, the tab,
acting as a Dispersion Limiting Device,
bends inwards towards the mask
During the expiratory phase, the
tab, acting as a Dispersion Limiting
Device, bends outwards from the
mask.
Soft
biocompatible
material
Dispersion
Limiting Device
CLEAnIng, SAnITIZATIOn AnD DISInFECTIOn
Turn o the unit before any cleaning and disconnect the power cord from the mains.
CLEAnIng THE DEVICE AnD THE TUBE’S OUTEr SUrFACE
Onlyuseaclothdampenedwithantibacterialdetergent(non-abrasiveandfreeofsolventsofanykind).
SAnITIZATIOn AnD DISInFECTIOn OF THE ACCESSOrIES
We recommend a personal use of both the nebulizer and accessories to avoid any risk of infection or
contagion.
Openthenebulizerbyrotatingtheupperpart(C1.3)counter-clockwise,detachthenozzlebypressing
as indicated by the 2 arrows in the “Assembly diagram” section C1.
SAnITIZATIOn
Before and after each use, sanitize the nebulizer and accessories according to one of the methods
descrive below.
(Method A): The accessories that can be sanitized with the method A are (C1.1-C1.2-C1.3-C1.4-C2-
C3-C4).Sanitizetheaccessoriesinwarm(approximately40°C)drinkingwaterwithmilddishwashing
liquid(nonabrasive)orinthedishwasherwithhotcycle
(Method B): The accessories that can be sanitized with the method B are (C1.1-C1.2-C1.3-C1.4-
C2-C3-C4).Sanitizetheaccessoriesbyimmersioninasolutionconsistingof60%waterand40%white
vinegar.Finallyrinsethoroughlywithwarm(approximately40°C)drinkingwater.
Aftersanitizationshaketheaccessoriesvigorouslyandplacethemonapapertowel,oralternatively,
drythemwithajetofhotair(e.g.usingahairdryer).
DISInFECTIOn
The accessories that can be disinfected are (C1.1-C1.2-C1.3-C1.4-C2-C3-C4)
The disinfection procedure described in this paragraph is to be performed before using the accessories
and is eective only if all the prescriptions herein are met and all the components involved are previously
sanitized.Thedisinfectanttobeusedmustbeofelectrolyticoxidizingchlorinetype,(activeingredient:
sodiumhypochlorite),specicfordisinfectionandisavailableinallpharmacies.
Procedure:
-Fillacontainer,suitabletocontainalltheindividualcomponentstobedisinfected,withasolutionof
drinkingwateranddisinfectant,whilerespectingtheproportionsindicatedonthepackagingofthe
disinfectant itself.
-Completelyimmerseeachindividualcomponentinthesolution,takingcaretoavoidtheformation
of air bubbles in contact with the components. Leave the components immersed for the period of
timeindicatedonthepackagingofthedisinfectant,andassociatedwiththeconcentrationchosento
prepare the solution.
- Remove the components now disinfected and rinse thoroughly with lukewarm drinking water.
-Afterdisinfectionshaketheaccessoriesvigorouslyandplacethemonapapertowel,oralternatively,
drythemwithajetofhotair(e.g.usingahairdryer).
- Dispose of the solution as recommended by the disinfectant manufacturer.
5
Description Code
- RF7 Dual Speed Plus Nebulizer Set composed of:
nebulizer,mouthpiecewithvalveandnosepiece ACO464P
- 1 m connection tube ACO35
- MaskSetcomposedof:adultmask,pediatricmaskandelasticband ACO462P
- SpareAirlterkitperunit(2pcs) ACO439P
AVAILABLE SPArE PArTS
AIr FILTEr
Thedevicehasasuctionlter(A3)thatshouldbereplacedwhenitisdirtyor
changes color. Do not wash or reuse the same lter. Regular replacement of
thelterisrequiredtohelpandensurecorrectperformanceofthecompressor.
Check the lter on a regular basis. Contact your local dealer or authorized
service center for spare lters.
Use original FLAEM accessories only.
Class II device
Important: check the operating
instructions
“OFF” for part of equipment
“ON” for part of equipment
Complies with: European standard
EN 10993-1 “Biological Evaluation of
Medical Devices” and European
Directive 93/42/EEC “Medical Devices”
Serial number of device
SyMBOLS
Type BF applied part
Alternating current
Hazard: electrocution.
Consequence: Death.
Do not use device while taking a
bath or shower
CE Medical Marking ref. Dir. 93/42
EEC and subsequent amendments
TÜV Certification
ref. EN 60601-1 3° Ed.
EN60601-1-11
Enclosure protection rating: IP21.
(Protected against solid bodies over 12 mm.
Protected against access with a finger; pro-
tected against vertically falling water drops.)
IP21

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