RF6 Basic 2 - Medical nebulizer Flaem - Free user manual and instructions

USER MANUAL RF6 Basic 2 Flaem

FLAEM Medical Devices

Medical Devices

RF6 Basic²

50

years of Italian excellence

PHTHALATES & BPA FREE

"RF6 Basic" dual speed nebuliser operating instructions.

PykoBoOCTBO NO 3KcNpyatauHn He6yna3epa "RF6Basic" C2CKopoCTAm paCnblneHn.

Congratulations on your purchase and thank you for choosing our unit.

Our goal is to fully satisfy customers by offering them cutting-edge systems for the treatment of respiratory tract ailments. Carefully read this instruction manual and store it for future reference. Only use the accessories as described in this manual. This is a home medical device to nebulise and administer medication prescribed or recommended by your doctor upon assessing the patient's general conditions. Visit our

Internet site www.flaem.it to view the whole range of Flaem products.

ACCESSIONS THAT CAN BE USED WITH THIS NEBULIZER

1 - Child nasal inhaler
2 - Adult nasal inhaler
3 - Child bi-material face mask
4 - Adult bi-material face mask
5 - Polyethylene (PE) face mask
6 - Medical PVC child face mask
7 - Medical PVC adult face mask
8 - Mouthpiece
9 - Baby mask set (see its instruction manual)
10 -Nebulisation manual control
11 - Connector
12-1 or 2m Connection hose

NEBULIZER

13 - RF6 Basic ^2 NEBULISER
13.1 - Lower part
13.2 - Complete nozzle
13.3 - Upper part
13.4 - Top ventilation cap

WARNING

• This is a medical device (compliant with Dir. 93/42/EEC) and may only be used with medication prescribed or recommended by a doctor. Before using the accessories, consult the instruction manual of the device. It is important that the patient reads and understands the information on how to use the device and the nebulizer. Contact your retailer or nearest service center for any questions.
• The expected medical life of the accessories is 1 year. It is, however, advisable to replace the nebuliser cup every 6 months in the event of intense use (or earlier if the cup is obstructed) to always guarantee maximum therapeutic efficacy.
• Children and disabled persons should always use the nebulizer under strict supervision of an adult who has read this manual.
• The nebulizer contains small parts that may be swallowed by children; keep therefore the nebulizer out of the reach of children

OPERATING INSTRUCTIONS

Before each use, clean hands thoroughly and clean the device as described in the section on "CLEANING SANITISATION DISINFECTION STERILISATION". 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.

This nebulizer is suitable for the administration of medical substances and not, for which the administration via aerosol is foreseen; these substances are to be in any case prescribed by the Doctor. In case of too thick substances, the dilution with a suitable physiological solution could be needed, according to the medical prescription.

1. Assemble the nozzle as indicated in the "Connection diagram" in point 13.2 Insert the complete nozzle in the bottom part (13.1). Insert the Upper ventilation cover (13.4) in the upper part (13.3) as shown in the "Connection diagram" in point 13.

2. Pour the medication prescribed by the physician into the lower part (13.1). Close the nebuliser by turning the upper part (13.3) clockwise.

3. Connect the accessories as indicated in the "Assembly diagram." Sit comfortably holding the nebuliser in your hand, place the mouthpiece onto your mouth or alternatively use the nosepiece, mask or newborn set.

4. Start the device (see its operating instructions). Gently take a deep breath; we recommend holding your breath for an instant to allow the inhaled drops of aerosol to deposit. Then exhale slowly.
5. Once the process is complete, switch off the device

ATTENTION: If after the therapy session an evident deposit of moisture forms within the pipe (12), detach the pipe from the nebuliser and dry it with ventilation from the said compressor; this operation prevents possible proliferation of mould inside the pipe.

HOW TO USE THE "RF6 Basic" DUAL SPEED NEBULISER

Due to the geometry inside the nebuliser it delivers a particle size providing effective treatment of the entire respiratory tract.

The RF6 Basic² nebuliser is especially suitable for paediatric use because the non-spill system prevents the medicine from leaking out even if it accidentally tips over (tested to work with up to 5 ml of product, which is the average dose of the most common therapeutic applications). The nebuliser can deliver the medicine in 2 ways:

"standard mode"

for excellent delivery and minimum medication waste.

"high speed mode"

for faster administration time.

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.

USE OF NEBULIZATION MANUAL CONTROL

To achieve continuous nebulisation action you should not use the manual nebulisation control (10), especially in the case of children or persons with reduced physical, sensory, or mental capabilities. The manual nebulisation control is useful for limiting dispersion of the medication in the surrounding environment.

To start nebulizing close with a finger the hole of the nebulizer manual control (10) and breathe in gently; we recommend to hold your breath for a moment so that the inhaled aerosol droplets can be deposited,

meanwhile, to disable nebulizing, remove your finger from the hole of the nebulizer manual control to avoid the waste of drug, optimizing its acquisition. Then exhale slowly.

CLEANING SANITISATION DISINFECTION STERILISATION

Switch off the device before any cleaning procedure and unplug the power cable from the socket.

DEVICE AND TUBING EXTERIOR (B)

Use only a damp cloth with antibacterial soap (non-abrasive and with no solvents of any sort).

ACCESSIONS

Open the nebuliser by turning the upper part (13.3) anticlockwise, remove the nozzle (13.2) from the upper part (13.3). Disassembly by pressing as shown by the 2 arrows in the "Connection diagram" in point 13.2.

Then proceed according to the following instructions.

CLEANING AT HOME - SANITISATION AND DISINFECTION

SANITISATION

Before and after each use, sanitise the nebuliser cup and the accessories, choosing one of the methods described below.

method A: Sanitise accessories 1-2-3-4-5-6-7-8-10-11-13.1-13.2-13.3-13.4 under potable hot water (approximately 40^ ) with a gentle, non abrasive dish detergent.

method B: Sanitise accessories 1-2-3-4-5-6-7-8-10-11-13.1-13.2-13.3-13.4 in the dishwasher with a hot cycle.

method C: Sanitise accessories 1-2-3-4-5-6-7-8-10-11-13.1-13.2-13.3-13.4 by immersing them in a solution of 50% water and 50% white vinegar, then rinse thoroughly under potable hot water (approximately 40^ ).

If you want to also perform the cleaning for DISINFECTION, jump to the DISINFECTION paragraph.

After having sanitised the accessories, shake them vigorously and place them on a paper towel. Alternatively, dry them with a jet of hot air (for example, a hair dryer).

DISINFECTION

After sanitising the nebuliser cup and the accessories, disinfect them choosing one of the methods described below.

method A: Accessories 1-2-3-4-5-6-7-8-10-11-13.1-13.2-13.3-13.4 can be disinfected. The disinfectant must be an electrolytic chloroxidizer (active principle: sodium hypochlorite) specific for disinfecting, which is available in any pharmacy.

Implementation:

• Fill a container big enough to hold all of the parts to disinfect with a solution of potable water and disinfectant, according to the proportions indicated on the packaging of the disinfectant.
• Completely immerse each part in the solution, taking care to avoid the formation of air

bubbles on the parts. Leave the parts immersed for the amount of time indicated on the packaging of the disinfectant associated with the concentration chosen for the solution.

• Remove the disinfected parts and rinse abundantly with warm potable water.
• Dispose of the solution following the instructions provided by the disinfectant manufacturer.

method B: Disinfect the accessories 1-2-3-4-8-10-11-13.1-13.2-13.3-13.4 by boiling them in water for 10 minutes; use demineralised or distilled water to prevent calcium deposits.

method C: Disinfect the accessories 1-2-3-4-8-10-11-13.1-13.2-13.3-13.4 with a hot steam steriliser for baby-bottle (not the microwave type). Perform the process faithfully following the instructions of the steriliser. To ensure that the disinfection is effective, choose a steriliser with an operating cycle of at least 6 minutes.

After having disinfected the accessories, shake them vigorously and place them on a paper towel. Alternatively, dry them with a jet of hot air (for example, from a hair dryer).

CLEANING IN A CLINICAL OR HOSPITAL SETTING - DISINFECTION AND STERILISATION Before disinfection or sterilisation, sanitise the nebuliser cup and the accessories, choosing one of the methods described below.

method A: Sanitise accessories 1-2-3-4-5-6-7-8-10-11-13.1-13.2-13.3-13.4 under potable hot water (approximately 40^ ) with a gentle, non abrasive dish detergent.

method B: Sanitise accessories 1-2-3-4-5-6-7-8-10-11-13.1-13.2-13.3-13.4 in the dishwasher with a hot cycle.

DISINFECTION

Accessories 1-2-3-4-5-6-7-8-10-11-13.1-13.2-13.3-13.4 can be disinfected.

The disinfectant must be an electrolytic chloroxidizer (active principle: sodium hypochlorite) specific for disinfecting, which is available in any pharmacy.

Implementation:

• Fill a container big enough to hold all of the parts to disinfect with a solution of potable water and disinfectant, according to the proportions indicated on the packaging of the disinfectant.
• Completely immerse each part in the solution, taking care to avoid the formation of air bubbles on the parts. Leave the parts immersed for the amount of time indicated on the packaging of the disinfectant associated with the concentration chosen for the solution.
• Remove the disinfected parts and rinse abundantly with warm potable water.
• Dispose of the solution following the instructions provided by the disinfectant manufacturer.

If you want to also perform the STERILISATION, jump to the STERILISATION paragraph.

After having disinfected the accessories, shake them vigorously and place them on a paper towel. Alternatively, dry them with a jet of hot air (for example, from a hair dryer).

STERILISATION

Accessories 1-2-3-4-8-11-13.1-13.2-13.3-13.4 can be sterilised.

Device: Fractionated vacuum overpressure steam steriliser in accordance with EN 13060.

Implementation: Wrap every single part to be treated with a sterile barrier system or packaging in accordance with Norm EN 11607. Place the packed components in the steam steriliser. Run the sterilisation cycle according to the operating instructions of the device by selecting a temperature of 134^ and a time of 10 minutes first.

Storage: Store the sterilised parts as per the instructions for use of either the sterile barrier system or packaging.

The sterilisation procedure is validated in its conformity to ISO 17665-1.

At the end of each use store the accessories in a dry place away from dust.

For the "CLEANING SANITISATION DISINFECTION STERILISATION" of accessories 9 follow the instructions in the instruction manual.

TECHNICAL SPECIFICATIONS

RF6 Basic2 Nebulizer

In compliance with 93/42/EEC Directive

Minimum fill volume: 2 ml

Maximum fill volume: 8 ml

APPLIED PARTS

The applied parts of type BF are: patient accessories (1, 2, 3, 4, 5, 6, 7, 8, 9)

Operating conditions:

Temperature: min 10^ ; max 40^

Air humidity: min 10%; max 95%

Atmospheric pressure: min 69KPa; max 106KPa

Storage conditions:

Temperature: min -25°C; max 70°C

Air humidity: min 10%; max 95%

Atmospheric pressure: min 69KPa; max 106KPa

FLAEM compressor range	Ope-rating pressure (bar)	MMAD (μm)\( ^{(2)} \)	BREATHABLE FRACTION< 5 μm (FPF) %(2)	DELIVERY ml/min\(^{(1)}\) (approx)
				standard mode	high speed mode
F400 0.60 3.06 73.97 0.25 0.32
F700 -F1000	0.80 3.3	2 71.91 0.32 0.42
(1) Data shown is in accordance with Flaem Nuova internal procedure I29-P07.5. Dispensing speed values may vary according to the patient's respiratory capacity.(2) In vitro testing performed by TÜV Rheinland Italia S.r.l. in collaboration with the University of Parma and in compliance with the EN 13544-1: 2007 + A1 European Standard for aerosol therapy devices Standard. More details are available on request.

SYMBOLS

EC Marking medical ref. Dir 93/42 EEC and subsequent updates	i	Check the instructions for use
In compliance with: European Standard EN 10993-1 "Biological Evaluation of medical devices" and European Directive 93/42/EEC "Medical Devices." Phthalate-free. In compliance with: Reg. (EC) no. 1907/2006	Manufacture LOT	Lot Number

PACKAGING DISPOSAL

Product packaging bag and Tube packaging bag

NÉBULISEUR POUR AÉROSOLTHÉRAPIE

Conditions de stockage:

Temperature: min -25^ ; max 70^

accessoires patient (1,2,3,4,5,6,7,8,9)

Bewaarinstructies:

Temperatuur: min -25^ max 70^

MEPbI INPEIOCTOPOXHOCTN

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5. ПО OKOHuaHn ИСПОЛьЗOBaHЯ BbIKIQUHTe npi6Op

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CINOCO6blNCIOJIb3OBAHN“RF6Basic2"

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Pacnbntb RF6 Basic² pekomeHdyeTcnaONb30BaTb dna deten, taK kaCneuaNbHa cnCTema npenrTCTByet BbIXOy lekapctBeHHoro cpeCTBa daXe npn ero nepeBopaunBAHN (ToJOBka 3ΦΦekTUBHa dna Han6Oonee pacnpocTpaHeHHo CpeDHe IO3NPOBKN 5Mn).

PacnbIInTeJIb IO3BOJrEePacnbIJIbTJeKapCTBeHHoe CpeiCTBO 2- rCnoc6aMn:

IJI ONTUMaJIbHOrO paCnblJeHnI MNHMaJIbHOJ DnCnepcNIN JeKapCTBeHHOrO cpeDCTBa.

"CTaHdapTHbI cnoco6"

"cnoco6 high speed"Дя Han6oJee 6bICTporcNcNoJb3ObaHn.

MACKN SOFTTOUCH

Märkni

6NOCOBMECTMmBIM MaTePnA

OrpaHnUHTeB 1ncpepcnn

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BdbixaTeNbHbIe NyTu,OCenN.

YHCTKA CAHITAPHO-ΓIΓNEHnueCKA OBPABOTKA Ie3INHΦEKLJN CTEPNJIN3AUJN

Ipeen hauanom liobon onepaun no nctke BbIKIOHTe np6op n 3BNEKNTe BNky TOKOIOBOJrero Ka6eJIa3 p03ETKn.

ПИБОР И HAPУЖHAЯ NOBEPXHOCTb TPYБК (В)

IcnoB3yTe TOnbKO BnaxHyIO TkaHb C aHTN6aKTepeNaIbHbIM MOIOUIM CpeCTBOM (OHO He DoJNKHO 6blb a6pa3NBbIM IN He DoJNKHO COepeKaTb pactBopntene JIO60rnpoNCXoxKeHnra).

DONOHINHEBHBIE PNHAIDIXHOCTN

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IeHCTbYnte daJe e cOrnaCHO npNBedeHHbIM HnKe INHCTpyKlunrM.

OCHCTKA B DOMAUHINX YCIOBnX - CAHITPAHO-ΓIΓNEHnueCKA OBPABOTKA I DE3nH-ΦEKUJ

CAHHTAPHO-ITNIEHINUECKAOBPABOTKA

KaJbIpa3do nnoCne npImeHnna npoBOnTe caHITapHO-rnueHnueckyO 6pa60Ky amnybln DO-ONHtJIbHbIX npHaadNEXKHOCTe OndHM N3 HxKepeBedeHHbIX cNoco6OB.

PpimHeBIMu qactmNTnFa BFyBnIOTc:KOMNoHEnTbI JnnaeHTa (1,2,3,4,5,6,7,8,9)

Pa6oynecycnobn:

Temnepa:MuHmMm 10^

MaKcMym40*C BnaxkHoctb BO3dyxa:

MNHIMyM 10%; MaKcIMyM 95%

Atmocphihoe daBHeHne: MNHMym 69 KPa;

MaKcMym 106 KPa

yCIOBnXpaHeHn:

TemnepaTpa: MHHmym -25°C, makcmmym 70°C

BnaXHOCTb BO3dyxa: MNHmym 10%; MaKcHmym 95%

AtmoccepehoeaBneHnE:MHmym69

TPONOI XPHES TOY NEΦEΛΟΙHTH "RF6 Basic" 2 TAXYTΩN

Xapn OTO EOWTEPIKO YEWETPIKO Oxma Tnc aunoula cvepeooinoc eITUYxavetai n ouviotwmeyn kai evpyn KOKKOTPIKn katavoun yia tn thepania ooknpwv twv avanveuotikwv odwv.

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1-2-3-4-5-6-7-8-10-11-13.1-13.2-13.3-13.4

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1

120 = 12 × 10

aill cllln no jglb y aag bil dylll cllgall glls

ybaa jia oja gle ciill julg jolg yba

Lgall glll lgl 100

Jalll Jlil jiljai jie gai jy jao jao jao jao jao jao jao jao jao jao

Jlll llllll 1111111111111111

1-2-3-4-8-10-11-13.1-13.2-13.3-13.4 g yj 10 a 1-2-3-4-8-10-11-13.1-13.2-13.3-13.4 yj: C a j j j j j j j j j j j j j j j j j j j j j j j j j j j j j j j j j j j j j j j j j j j j j j j j j j j j j j j j j j j j j j j j j j j j j j j j j

i 1-2-3-4-5-6-7-8-10-11-13.1-13.2-13.3-13.4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4

1-2-3-4-8-11-13.1-13.2-13.3-13.4 1-2-3-4-8-11-13.1-13.2-13.3-13.4 1-2-3-4-8-11-13.1-13.2-13.3-13.4 1-2-3-4-8-11-13.1-13.2-13.3-13.4 EN 13060 JIJIJIJIJIJIJIJIJIJIJIJIJIJIJIJIJIJIJIJIJIJIJIJIJIJIJIJIJIJIJIJIJIJIJIJIJIJIJIJIJIJIJIJIJIJIJIJIJIJIJIJIJIJIJIJIJIJIJIJIJIJIJIJIJIJIJIJIJIJIJIJIJIJIJIJIJIJIJIJIJIJIJIJIJIJIJIJIJIJIJIJIJIJIJ

RF6 Basic 2
70° 125° 40° 10° 95% 10% 95% KPa 106 KPa 69 KPa 106 KPa 69 CEE 93/42 2:JzBd 118 Jla 2:JzBd 118 Jla 8:JzBd 118

EN> The warranty terms here specified are valid only in Italy for Italian residents. In all other countries, the warranty will be provided by the local dealer that sold you the unit, in accordance with the applicable laws.