Flaem NebulFlaem 4.0 - Nebulizer

NebulFlaem 4.0 - Nebulizer Flaem - Free user manual and instructions

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USER MANUAL NebulFlaem 4.0 Flaem

years of italian excellence

Flaem NebulFlaem 4.0 - 1

text_image C3 C4 C2.1 C2 C5 C1 C6 B A A1 A4 A2 A3 C1 C1.1 C1.1a C1.1b C1.1c C1.1 C1.2 C1.3 C1.4 A7 A6 A5 Protected by BioCote®

Connection diagram - Anschlussschema - Schéma de montage -Verbindingsschema -Esquema de conexión - Διάγραμμα συναρμολόγησης - Schemat połączeń dla nomenklatury- جدول التوصيلات

Flaem NebulFlaem 4.0 - 2

Flaem NebulFlaem 4.0 - 3

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Flaem NebulFlaem 4.0 - 5

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NebulFlaem ^4.0

Mod. CONDOR F2000

AEROSOL THERAPY DEVICE

We are pleased you have purchased our product and we thank you for your trust in us. We aim atfully satisfying our customers by offering them state-of-the-art products for the treatment of respiratory diseases.

Read these instructions carefully and retain them for future reference. Only use the accessory 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. Please note that the

full range of Flaem products is visible on the website www.flaem.it.

STANDARD EQUIPMENT INCLUDES:

A - Aerosol apparatus (main unit)

A1 - On/Off switch

A2 - Air intake

A3 - Air filter

A4 - Nebulizer holder

A5 - Handle for transport

A6 - Cable storage compartment

A7 - Power cable

B - Connection tube (main unit / nebulizer)

C - Accessories

C1 - RF9 Nebulizer

C1.1 - Complete particle size regulator

C1.1a - Regulator

C1.1b - Valve

C1.1c - Selector

C1.2 - Upper part

C1.3-Nozzle

C1.4 - Lower part

C2 - Mouthpiece with valve

C2.1 - Exhalation valve

C3 - Non-invasive nosepiece

C4 - Adult SoftTouch mask

C5 - Paediatric SoftTouch mask

C6 - Nebulization manual control

IMPORTANT WARNINGS

- This device is also intended for direct use by the patient.

- Before using the product for the first time, and periodically during its lifetime, check the integrity of the device structure and of the power cable to make sure there is no damage. In the event of damage, do not plug in the cable and immediately take the product to an authorised FLAEM service centre or to your trusted dealer.

- Should your device fail to provide the expected performance, contact the authorised service centre for clarifications.

- The expected medical life of the accessories is 1 year. It is, however, advisable to replace the nebulizer 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 people who are not self-sufficient must use the device under the close supervision of an adult who has read this manual.

- Some parts of the device are small enough to be swallowed by children; therefore, keep the device out of the reach of children.

- Do not use the supplied tubing and cables for anything other than their intended use. These parts could cause a strangling hazard: pay close attention to children and persons with particular difficulties as they are often unable to accurately evaluate danger.

• The apparatus is unsuitable for use in presence of flammable anaesthetic mixture with air, oxygen or nitrous oxide.

• Always keep the power supply cable away from hot surfaces.

- Keep the power cable away from animals (for example, rodents) which could damage the insulation.

- Do not handle the device with wet hands. Do not use the device in damp environments (for example, while taking a bath or shower). Do not immerse the device in water; in the event of immersion immediately disconnect the plug. Do not remove or touch the immersed device; unplug the power cable first. Immediately bring the device to an authorised FLAEM service centre or to your trusted dealer.

- Use the device only in dust-free conditions, otherwise treatment could be compromised.

- Do not wash the device under running water or by immersion and keep it safe from being sprayed by water or other liquids.

- Do not expose the device to particularly extreme temperatures.

- Do not place the device near sources of heat, in direct sunlight or in excessively hot rooms.

- Do not obstruct or put objects into the filter or its related housing in the device.

- Never obstruct the air vents located on both sides of the device.

• Always use it on a rigid surface that is clear of obstacles.

- Make sure there is no material obstructing the air vents before each use.

  • Do not put any objects in the air vents.
  • Repairs, including the replacement of the supply cord, are to be carried out by FLAEM authorised personnel only, by complying with the information provided by the manufacturer.
  • The average expected duration for the compressor series are: F400: 400 hours, F700: 700 hours, F1000: 1000 hours, F2000: 2000 hours.
  • WARNING: Do not modify this device without authorisation from the manufacturer.
  • The Manufacturer, the Vendor and the Importer shall be held responsible for safety, reliability and performance only if: a) the device is used in compliance with the instructions for use b) the wiring where the device is being used is in compliance with safety regulations and current laws.
  • Interactions: the materials used in contact with medication have been tested with a vast range of medications. However, in view of the variety and continuous evolution of pharmaceuticals, interactions cannot be ruled out. We recommend using the medication as soon as possible once it has been opened and preventing prolonged exposure in the nebulizer cup.
  • The manufacturer must be contacted about any problems and/or unexpected events concerning operation and for any clarifications on use, maintenance/cleaning.
  • Interactions: The materials used in the medical device are biocompatible in accordance with the provisions of Directive 93/42 EC and subsequent amendments. However, the possibility of occurrence of allergic reactions cannot be entirely excluded.
  • The amount of time required between preservation conditions and use is approximately 2 hours.

Benefits of BioCote protection

The enclosure of NebulFlaem 4.0 are made of ABS mixed with antimicrobial additive BioCote ^® , which makes the surfaces protected 24 hours a day and permanently provides antibacterial, antifungal and antiviral properties. Store accessories in a more secure environment.

ASSEMBLING THE NEBULISER

Follow the assembly instructions below.

  1. Assemble the nozzle (C1.3) on the upper part (C1.2).

Flaem NebulFlaem 4.0 - ASSEMBLING THE NEBULISER - 1

text_image C1.2 C1.3

Flaem NebulFlaem 4.0 - ASSEMBLING THE NEBULISER - 2

text_image C1.2 C1.3
  1. Place the valve (C1.1b) with the flat side down onto the particle size regulator (C1.1a) by aligning the hole with the position ribs, then screw the selector (C1.1c) onto the threaded pin of the regulator all the way down. Rotate the assembled regulator to make sure that it turns freely and that the selector moves up and down between positions.

Flaem NebulFlaem 4.0 - ASSEMBLING THE NEBULISER - 3

flowchart
graph TD
    A["C1.1a"] --> B["C1.1b"]
    B --> C["Component 1"]
    C --> D["C1.1c"]
    D --> E["C1.1a + C1.1b"]
  1. Insert and press the previously assembled particle size regulator (C1.1) all the way down, keeping it in a horizontal position, in the upper part (C1.2), and matching the partitions of the selector (C1.1c) with the groove in the upper part (C1.2).

Flaem NebulFlaem 4.0 - ASSEMBLING THE NEBULISER - 4

text_image C1.2 C1.1c C1.1
  1. Insert the assembled upper part (C1.1 + C1.2 + C1.3) into the lower part (C1.4) and hook it by turning it clockwise.

Flaem NebulFlaem 4.0 - ASSEMBLING THE NEBULISER - 5

text_image C1.1+C1.2+C1.3 a b C1.4

HOW TO USE THE RF9 NEBULISER WITH PARTICLE SIZE REGULATOR AND VALVE SYSTEM

It is professional, quick, recommended for administering all types of medicinal products, even in patients with chronic diseases. The valve system optimises the dispensing of the nebulised medicinal product to the patient and limits its dispersion in the environment. Moreover, thanks to the particle size regulator, the size of nebulised particles can be selected based on the respiratory system area where the medication is to be delivered. Indeed, with the 4 available modes, the bowl can dispense particles of different sizes:

RESPIRATORY SYSTEMUPPER AIRWAYSLOWER AIRWAYS
Oropharyngeal tractTracheobronchial tractPulmonary tractPeripheral tract
CONFIGURATION BOWLWithout SelectorSelector in position 1Selector in position 2Selector in position 3
Flaem NebulFlaem 4.0 - HOW TO USE THE RF9 NEBULISER WITH PARTICLE SIZE REGULATOR AND VALVE SYSTEM - 1Flaem NebulFlaem 4.0 - HOW TO USE THE RF9 NEBULISER WITH PARTICLE SIZE REGULATOR AND VALVE SYSTEM - 2Flaem NebulFlaem 4.0 - HOW TO USE THE RF9 NEBULISER WITH PARTICLE SIZE REGULATOR AND VALVE SYSTEM - 3Flaem NebulFlaem 4.0 - HOW TO USE THE RF9 NEBULISER WITH PARTICLE SIZE REGULATOR AND VALVE SYSTEM - 4
MMAD (μm)5,80(3)4,67(1)3,62(1)2,56(1)
Output rate (ml/min')0,75(2)0,54(2)0,51(2)0,38(2)
Breathable fraction < 5 μm (FPF)40,3(3)54,4(1)66,3(1)82,2(1)
(1) 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.(2) Data measured according to Flaem I29-P07.5 internal procedure Dispensing speed values may vary according to the patient's respiratory capacity. More details are available on request.(3) Data calculated on the basis of the values obtained with Malvern Spraytec, and compared with the values of the tests performed at the University of Parma.

(1) 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.

(2) Data measured according to Flaem I29-P07.5 internal procedure Dispensing speed values may vary according to the patient's respiratory capacity. More details are available on request.

(3) Data calculated on the basis of the values obtained with Malvern Spraytec, and compared with the values of the tests performed at the University of Parma.

Select the desired position by means of the particle size regulator C1.1.

By turning the regulator clockwise, the selector (C1.1c) moves and closes the opening, while it opens if the regulator is turned anti-clockwise.

Flaem NebulFlaem 4.0 - HOW TO USE THE RF9 NEBULISER WITH PARTICLE SIZE REGULATOR AND VALVE SYSTEM - 5

natural_image Diagram of a wheel with directional arrows indicating rotation and movement, no text or symbols present

To use the bowl without selector, firmly grasp the bowl body and use your other hand to rotate the particle size regulator (C1.1) clockwise until it is ejected from the upper part (C1.2).

Flaem NebulFlaem 4.0 - HOW TO USE THE RF9 NEBULISER WITH PARTICLE SIZE REGULATOR AND VALVE SYSTEM - 6

text_image C1.1 C1.2

INSTRUCTIONS FOR USE

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

This device 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. Plug the power cord (A7) into a power socket corresponding to the voltage of the unit. This must be positioned so that it is not difficult to make the disconnection from the mains.

  2. Pour the medication prescribed by the physician into the lower part (C1.4). Insert the upper part (C1.1+C1.2+C1.3) of the bowl into the lower part (C1.4), then close the bowl by turning the upper part (C1.2) clockwise. Close the nebulizer by turning the upper part (C1.2) clockwise.

  3. Connect accessories as indicated in the "Connection diagram" on the cover.

  4. Set the bowl selector to the desired particle size as described under "HOW TO USE THE RF9 NEBULIZER WITH PARTICLE SIZE REGULATOR AND VALVE SYSTEM

  5. Sit comfortably holding the nebulizer 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. Start the device by operating the switch (A1). Inhale gently and deeply; after inspiration we recommend to hold your breath for a moment in order to allow inhaled aerosol droplets to deposit. Then, exhale slowly.

  7. When the treatment is finished, shut off 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.

Flaem NebulFlaem 4.0 - INSTRUCTIONS FOR USE - 1

natural_image Line drawing of two people wearing face masks, one holding a cup and the other smoking a bottle (no text or symbols)

USE OF NEBULIZATION MANUAL CONTROL

To achieve continuous nebulisation action you should not use the manual nebulisation control (C6), 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.

Flaem NebulFlaem 4.0 - USE OF NEBULIZATION MANUAL CONTROL - 1

To start nebulizing close with a finger the hole of the nebulizer manual control (C11) and breathe in gently; we recommend to hold your breath for a moment so that the inhaled aerosol droplets can be deposited,

Flaem NebulFlaem 4.0 - USE OF NEBULIZATION MANUAL CONTROL - 2

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.

Dispersion Limiting Vent

The new SoftTouch Masks feature an adaptive edge made of a soft biocompatible material ensuring an excellent adherence to the face and a Dispersion Limiting Vent. These innovations, which make them stand out from the rest, allow increased sedimentation of medication in the lungs and reduced dispersion into the air.

Flaem NebulFlaem 4.0 - USE OF NEBULIZATION MANUAL CONTROL - 3

During inspiration the vent bends inwards.

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During expiration the vent bends outwards.

CLEANING, SANITISATION, DISINFECTION, STERILISATION

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

DEVICE (A) AND TUBING EXTERIOR (B)

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

ACCESSORIES

To disassemble the RF9 nebulizer.

Firmly grasp the bowl body and then use your other hand to rotate the particle size regulator (C1.1) clockwise until it is ejected from the upper part (C1.2) as a result of unscrewing. The components can then be disassembled (regulator C1.1a, valve C1.1b, selector C1.1c and upper part C1.2) to be cleaned. The nozzle (C1.3) is interference fitted in the upper part (C1.2) and can be extracted by simply pulling it outwards.

Then proceed according to the instructions below.

CLEANING AT HOME - SANITISATION AND DISINFECTION

SANITISATION

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

method A: Sanitise accessories C1.1a-C1.1b-C1.1c-C1.2-C1.3-C1.4-C2-C3-C4-C5-C6 under potable hot water (approximately 40^ C) with a gentle, non abrasive dish detergent.

method B: Sanitise accessories C1.1a-C1.1b-C1.1c-C1.2-C1.3-C1.4-C2-C3-C4-C5-C6 in the dishwasher with a hot cycle.

method C: Sanitise accessories C1.1a-C1.1b-C1.1c-C1.2-C1.3-C1.4-C2-C3-C4-C5-C6 by immersing them in a solution of 50% water and 50% white vinegar, then rinse thoroughly under potable hot water (approximately 40°C).

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

method A: Accessories C1.1a-C1.1b-C1.1c-C1.2-C1.3-C1.4-C2-C3-C4-C5-C6 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: Sanitise the accessories C1.1a-C1.1b-C1.1c-C1.2-C1.3-C1.4-C2-C3-C4-C5-C6 by boiling them in water for 10 minutes; use demineralised or distilled water to prevent calcium deposits.

method C: Sanitise the accessories C1.1a-C1.1b-C1.1c-C1.2-C1.3-C1.4-C2-C3-C4-C5-C6 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 C1.1a-C1.1b-C1.1c-C1.2-C1.3-C1.4-C2-C3-C4-C5-C6 under potable hot water (approximately 40°C) with a gentle, non abrasive dish detergent.

method B: Sanitise accessories C1.1a-C1.1b-C1.1c-C1.2-C1.3-C1.4-C2-C3-C4-C5-C6 in the dishwasher with a hot cycle.

DISINFECTION

Accessories C1.1a-C1.1b-C1.1c-C1.2-C1.3-C1.4-C2-C3-C4-C5-C6 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 C1 (Assembled nebulizer) -C2-C3-C4-C5-C6 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^ C 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 device complete with accessories in a dry place away from dust.

AIR FILTERING

The device is quipped with an extraction filter (A3) that must be replaced when it is dirty or changes colour. Do not wash or reuse the same filter. Regular filter replacement is necessary to help ensure proper compressor performance. The filter must be checked regularly.

To replace the filter:

Insert a slotted screwdriver between the edge of the filter and the body. Lift the filter and extract it by rotating and pulling up. The filter was designed to always remain secured in its seat. Do not replace the filter during use.

Flaem NebulFlaem 4.0 - AIR FILTERING - 1

natural_image Line drawing of a screwdriver inserted into a car door handle (no text or symbols)

Only use original accessories and spare parts by Flaem, we disclaim any liability in the event of using non original spare parts or accessories.

TROUBLESHOOTING

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

PROBLEM CAUSE SOLUTION
The device does not workThe power cable has not been correctly inserted into the power socketCorrectly insert the power cable in sockets.
The device does not nebulize or nebulizes insufficiently.The medication has not been inserted in the nebulizerPour the right amount of medication in the nebulizer
The nebulizer has not been properly fitted.Disassemble the nebulizer and reassemble it correctly as shown in the connection diagram on the cover.
The nebulizer nozzle is cloggedDisassemble the nebulizer, remove the nozzle and perform cleaning operations.Failure to remove medication deposits from the nebulizer affects its efficiency and operation.Strictly comply with the instructions contained in the “CLEANING, SANITISATION DISINFECTION” chapter
The air pipe is not correctly connected to the deviceEnsure the device’s accessories are properly connected to the air intake (see connection diagram on the cover).
The air pipe is bent, damaged or twistedUnwind the pipe and ensure it is not crushed or punctured. If necessary replace it.
The air filter is dirty Replace the filter
The apparatus is noisier than usualThe Filter is not correctly inserted in its housingFully and properly insert the Filter in its housing

If after verifying the above mentioned conditions the device should not operate properly, contact your trusted retailer or the nearest authorized FLAEM service center.

SYMBOLS

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Flaem NebulFlaem 4.0 - SYMBOLS - 2

CE Medical Marking ref. Dir. 93/42 EEC and subsequent amendments

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Class II device Manufacturer

Flaem NebulFlaem 4.0 - SYMBOLS - 4

Important: check the operating instructions Type

Flaem NebulFlaem 4.0 - SYMBOLS - 5

"OFF" for part of equipment

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"ON" for part of equipment

Flaem NebulFlaem 4.0 - SYMBOLS - 7

PHTHALATES & BPA FREE

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Complies with: European standard EN 10993-1 "Biological Evaluation of Medical Devices" and European Directive 93/42/EEC "Medical Devices". Phthalates free. In conformity with Reg. (EC) no. 1907/2006

Flaem NebulFlaem 4.0 - SYMBOLS - 9

Minimum and maximum room temperature Min

Minimum and maximum atmospheric pressure

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Serial number of device

Flaem NebulFlaem 4.0 - SYMBOLS - 11

Flaem NebulFlaem 4.0 - SYMBOLS - 12

lied part

Flaem NebulFlaem 4.0 - SYMBOLS - 13

Alternating current

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Enclosure protection rating: IP21. (Protected against solid bodies over 12 mm. Protected against access with a finger; Protected against vertically falling water drops).

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and maximum air moisture

TECHNICAL SPECIFICATIONS

Mod. CONDOR F2000

Voltage: 230V~50Hz 210VA 115V~60Hz 220V~60Hz 100V~50/60Hz

Max pressure: 3.5 ± 0.3 bar

Compressor air delivery: approx 14 l/min

Noise (at 1 m): approx 55 dB (A)

Operation: Continuous

Operating Conditions:

Temperature: min 10°C; max 40°C

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

Dimensions: 20 (W) x 29,5 (D) x 10 (H) cm

Weight: 2.400 Kg

APPLIED PARTS

Type BF applied parts are: patient accessories (C2, C3, C4, C5)

RF9

Minimum medication capacity: 2 ml

Maximum medication capacity: 8 ml

Operating pressure (with neb.): approx. 1.30 bar

ELECTROMAGNETIC COMPATIBILITY

This device was designed to satisfy the currently required requisites for electromagnetic compatibility (EN 60601-1-2). Electro-medical devices require particular care during installation and use relative to EMC requirements. Users are therefore requested to install and/or use these devices following the manufacturer's specifications. There is a risk of potential electromagnetic interference with other devices. RF mobile or portable radio and telecommunications devices (mobile telephones or wireless connections) can interfere with the functioning of electro-medical devices. For further information visit our website www.flaemnuova.it. The Medical Device may be subject to electromagnetic interference if other devices are used for specific diagnosis or treatments. Flaem reserves the right to make technical and functional modifications to the product with no prior warning.

DEVICE DISPOSAL

In compliance with the Directive 2012/19/EC, the symbol printed on the device shows that the device to be disposed of is considered waste and must therefore be an item of "differentiated collection". Consequently, the user must take it (or have it taken) to the designated collection sites provided by the local authorities, or turn it in to the dealer when purchasing an equivalent new device. Differentiated waste collection and the subsequent treatment, recycling and disposal procedures promote the production of devices made with recycled materials and limit the negative effects on the environment and on health caused by potential improper waste management. The unlawful disposal of the product by the user could result in administrative fines as provided by the laws transposing Directive 2012/19/EC of the European member state or of the country in which the product is disposed of.

PACKAGING DISPOSAL

Flaem NebulFlaem 4.0 - PACKAGING DISPOSAL - 1

Product box

Flaem NebulFlaem 4.0 - PACKAGING DISPOSAL - 2

Heat shrink film accessories

Flaem NebulFlaem 4.0 - PACKAGING DISPOSAL - 3

Product packaging bag and

Tube packaging bag

Flaem NebulFlaem 4.0 - PACKAGING DISPOSAL - 4

NebulFlaem ^4.0

Mod. CONDOR F2000

GERÄT FÜR AEROSOLTHERAPIE

text_image C1.2 C1.3

Flaem NebulFlaem 4.0 - GERÄT FÜR AEROSOLTHERAPIE - 1

text_image C1.2 C1.3
text_image C1.2 C1.1c C1.1
text_image C1.1+C1.2+C1.3 a b C1.4
natural_image Diagram of a wheel with directional arrows indicating rotation and movement (no text or symbols)
text_image C1.1 C1.2

BEDIENUNGSANLEITUNG

natural_image Line drawing of two people using nasal cannulas, one holding a cup and the other blowing a nasal tube (no text or symbols)
natural_image Line drawing of a screwdriver holding a tool near a mechanical component (no text or symbols)
text_image C1.2 C1.3

Flaem NebulFlaem 4.0 - BEDIENUNGSANLEITUNG - 1

text_image C1.2 C1.3
text_image C1.2 C1.1c C1.1
text_image b C1.1+C1.2+C1.3 a C1.4
natural_image Diagram of a wheel with water droplets, showing rotational direction (no text or symbols)
text_image C1.1 C1.2

INSTRUCTIONS D'UTILISATION

natural_image Line drawing of two individuals using nasal cannulas, one holding a cup and the other listening to a nasal tube (no text or symbols)
natural_image Line drawing of a screwdriver inserted into a car body panel (no text or symbols)

Conditions de stockage:

Température:min -25°C; max 70°C
RH Humidité air:min 10%; max 95%
Pression atmosphérique:min 69KPa; max 106KPa
Dimensions (L)x(P)x(H):20x29,5x10 cm
Poids:2,400 Kg

PARTIES APPLIQUEES

B - Connection tube (main unit)

C -Accessories

C1 - Vernevelaar RF9

C1.1 - Complete granulometrieregelaar

C1.1a - Regelaar

C1.1b - Klep

text_image C1.2 C1.3

Flaem NebulFlaem 4.0 - C -Accessories - 1

text_image C1.2 C1.3
flowchart
graph TD
    A["C1.1a"] --> B["C1.1b"]
    B --> C["Component with threaded shaft"]
    C --> D["C1.1c"]
    D --> E["C1.1a + C1.1b"]
text_image C1.2 C1.1c C1.1
text_image C1.1+C1.2+C1.3 a b C1.4

GEBRUIKSWIJZEN VAN DE VERNEVELAAR RF9 MET GRANULOMETRIEREGELAAR EN KLEPPENSYSTEEM

natural_image Diagram of a circular mechanical component with directional arrows indicating rotation and movement (no text or symbols)
text_image C1.1 C1.2

GEBRUIKSAANWIJZING

natural_image Line drawing of two people wearing gas masks, one holding a cup and the other eating from a mouth (no text or symbols)

GEBRUIK VAN DE HANDMATIGE BESTURING VAN DE VERNEVELAAR

APPARAAT (A) EN BUITENKANT VAN DE BUIS (B)

natural_image Diagram of a screwdriver operating on a car door panel (no text or symbols visible)
text_image C1.2 C1.3

Flaem NebulFlaem 4.0 - APPARAAT (A) EN BUITENKANT VAN DE BUIS (B) - 1

text_image C1.2 C1.3
text_image C1.2 C1.1c C1.1
text_image C1.1+C1.2+C1.3 a b C1.4
text_image Diagram showing a wheel with water droplets and directional arrows, indicating flow or circulation around the wheel.
text_image C1.1 C1.2

INSTRUCCIONES DE USO

natural_image Line drawing of two people wearing face masks, one holding a cup and the other drinking from a bottle (no text or symbols)
natural_image Diagram of a hand using a screwdriver to adjust or install a mechanical component (no text or symbols visible)
text_image C1.2 C1.3 C1.2 C1.3
text_image C1.2 C1.1c C1.1
text_image C1.1+C1.2+C1.3 a b C1.4
natural_image Diagram of a wheel with water droplets, showing rotational direction (no text or symbols)
text_image C1.1 C1.2

ΟΔΗΓΙΕΣ ΧΡΗΣΗΣ

natural_image Line drawing of two people using nasal cannulas, one with a clear filter and the other holding a nasal tube (no text or symbols)
natural_image Line drawing of a screwdriver holding a mechanical component (no text or symbols)
text_image C1.2 C1.3

Flaem NebulFlaem 4.0 - ΟΔΗΓΙΕΣ ΧΡΗΣΗΣ - 1

text_image C1.2 C1.3
text_image C1.2 C1.1c C1.1
text_image C1.1+C1.2+C1.3 a b C1.4

SPOSÓB UŻYCIA NEBULIZATORA RF9 Z REGULATOREM WIELKOŚCI CZĄSTEK I SYSTEMEM ZAWORÓW

text_image Diagram showing a circular component with water droplets and directional arrows, possibly indicating flow or circulation.
text_image C1.1 C1.2

INSTRUKCJA OBSŁUGI

natural_image Line drawing of two people using nasal cannulas, one holding a cup and the other blowing a cup (no text or symbols)

STOSOWANIE RĘCZNEGO STEROWANIA INHALACJA

natural_image Diagram of a screwdriver inserted into a mechanical component (no text or symbols visible)
text_image C1.2 C1.1c C1.1
text_image C1.1+C1.2+C1.3 a b C1.4
text_image C1.2 C1.3

Flaem NebulFlaem 4.0 - STOSOWANIE RĘCZNEGO STEROWANIA INHALACJA - 1

text_image C1.2 C1.3
natural_image Diagram of a wheel with directional arrows indicating rotation and movement (no text or symbols)
text_image C1.1 C1.2

تعليمات الاستخدام

natural_image Line drawing of two people wearing face masks, one holding a small object near the mouth (no text or symbols)
natural_image Line drawing of a screwdriver inserted into a grid notebook (no text or symbols)

ترشيح الهواء

EN >The warranty will be provided by the local retailer in accordance with the applicable lows.

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Product information

Brand : Flaem

Model : NebulFlaem 4.0

Category : Nebulizer