Ghibli Plus - Inhaler Flaem-Nuova - Free user manual and instructions

Product type	Compressor inhaler for aerosol therapy
Model	Ghibli Plus (P0211EM F400)
Brand	Flaem-Nuova
Power supply	230 V ~ 50 Hz, 130 VA (115 V ~ 60 Hz / 220 V ~ 60 Hz versions available)
Maximum pressure	1,8 ± 0,3 bar
Compressor air flow	approx. 9 L/min
Noise (at 1 m)	approx. 54 dB(A)
Operation	Continuous
Nebulizer capacity	2 to 8 ml of medication
MMAD (particle size)	3,8 µm (standard mode) / 4,0 µm (high speed mode)
Respirable fraction < 5 µm	62% (standard) / 63% (high speed)
Nebulization rate	0,25 ml/min (standard) / 0,32 ml/min (high speed)
Included accessories	RF6 Basic² nebulizer, mouthpiece, adult mask, child mask, connection tube, spare air filter
Air filter	Replaceable; change when dirty or discolored
Operating conditions	Temperature: 10°C to 40°C; humidity: 10% to 95%; atmospheric pressure: 69 to 106 kPa
Compressor lifespan	400 hours (model F400)
Safety class	Class II, type BF applied part, IP21
Maintenance	Clean accessories after each use; disinfect by boiling, steam, or chlorinated solution
Warranty	Warranty provided by the retailer in accordance with applicable laws

Frequently Asked Questions - Ghibli Plus Flaem-Nuova

How to use the Ghibli Plus inhaler?

Wash your hands, assemble the nebulizer (lower part, nozzle, upper part, ventilation port), pour the prescribed medication (2-8 ml), close the nebulizer by turning the upper part clockwise, connect the mouthpiece or mask, plug in the device, turn it on with the switch (A1) and breathe deeply. After use, turn off the device and unplug it.

How to clean the nebulizer and accessories?

After each use, clean the parts (C1.1, C1.2, C1.3, C1.4, C2, C3, C4) with warm water (approx. 40°C) and a mild detergent, or in a dishwasher (hot cycle), or soak them in a 50% water - 50% white vinegar mixture then rinse thoroughly. Dry them with a hot air jet or on a paper towel.

When should the air filter be replaced?

Replace the air filter (A3) when it is dirty or has changed color. Never replace it while the device is in use.

What to do if the device does not nebulize or nebulizes poorly?

Check that the medication has been poured into the nebulizer, that it is correctly assembled, that the nozzle is not blocked (clean it if necessary), that the connection tube is properly connected and not bent/punctured, and that the air filter is not dirty. If the problem persists, contact a FLAEM authorized service center.

What type of medication can be used?

Only use medications prescribed by your doctor and suitable for aerosol administration. If the medication is too thick, dilute it with physiological saline according to medical prescription.

How to assemble the nebulizer?

Mount the nozzle (C1.2) on the lower part (C1.1). Insert the upper ventilation port (C1.4) into the upper part (C1.3). Pour the medication into the lower part, then close by screwing the upper part clockwise.

Can I use the device with a child mask?

Yes, the device is supplied with a child mask (C4). Use it according to the instructions, under adult supervision. SoftTouch masks are biocompatible and limit medication dispersion.

How to disinfect the accessories?

After cleaning, you can disinfect the accessories (C1.1-C1.2-C1.3-C1.4-C2-C3-C4) by immersion in a sodium hypochlorite solution (follow the doses and times indicated), by boiling for 10 minutes in demineralized water, or by using a baby bottle steam sterilizer (cycle of at least 6 minutes). Rinse thoroughly afterwards.

What does High Speed mode mean?

The upper ventilation port (C1.4) allows two modes: Standard (optimal flow, low dispersion) and High Speed (faster application). In High Speed mode, the nebulization rate is higher (0.32 vs 0.25 ml/min) and the particle size slightly larger.

Where to find spare parts?

Only use original Flaem accessories and spare parts. You can order the RF6 Basic² nebulizer (ref. ACO369P), mouthpiece (ACO462P), tube (ACO35), air filter (ACO439P) and masks from your dealer or a FLAEM authorized service center.

USER MANUAL Ghibli Plus Flaem-Nuova

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	2017
Cost of goods sold	3,564
Cost of products sold	3,564
Cost of service and other	(1,899)
Total cost of goods sold	$3,564

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Ghibli Plus

Mod. P0211EM F400 Aerosol therapy unit

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.

THE STANDARD COMPONENTS AND ACCESSORIES OF THE UNIT INCLUDE:

A - Aerosoltherapy unit (main unit)

A1 - On/off switch

A2 - Air outlet port

A3 - Air filter

A4 - Nebuliser holder

A5 - Carrying handle

A6 - Power cord

B - Connection tube (main unit / nebuliser)

C - Accessories

C1 - RF6 Basic ^2 nebuliser

C1.1 - Lower part

C1.2 - Complete nozzle

C1.3 - Upper part

C1.4 - Top ventilation cap

C2 - Mouthpiece

C3 - Adult mask

C4 - Child mask

IMPORTANT SAFEGUARDS

• 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 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 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. Unauthorized repairs will void the warranty and may represent a danger to the user.

- 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 nebuliser 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.

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 (A6) 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. Assemble the nozzle as indicated in the "Connection diagram" in point C1.2 Insert the complete nozzle in the bottom part (C1.1). Insert the Upper ventilation cover (C1.4) in the upper part (C1.3) as shown in the "Connection diagram" in point C1.

3. Pour the medication prescribed by the physician into the lower part (C1.1). Close the nebuliser by turning the upper part (C1.3) clockwise.

4. Connect accessories as indicated in "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).

The cap (C1.4) provided with the nebuliser RF6 Basic ^2 makes it possible to deliver the medication in 2 modes:

"standard mode", for optimum delivery and minimum waste of medication

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"high speed mode" for a quicker treatment

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1. Start the unit by means of switch (A1) and 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.

2. When the treatment is finished, turn off and unplug the unit.

WARNING: If after the therapy session moisture accumulates in the tube (B), remove the tube from the nebulizer and dry it using the compressor air flow; this operation will prevent mold from forming inside the tube.

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.

CLEANING SANITISATION DISINFECTION

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

Open the nebuliser by turning the upper part (C1.3) anticlockwise, remove the nozzle (C1.2) from the upper part (C1.3). Disassembly by pressing as shown by the 2 arrows in the "Connection diagram" in point C1.2.

Then proceed according to the following instructions.

SANITISATION

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

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

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

method C: Sanitise accessories C1.1-C1.2-C1.3-C1.4-C2-C3-C4 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 DISINFEC-TION 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 C1.1-C1.2-C1.3-C1.4-C2-C3-C4 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 C1.1-C1.2-C1.3-C1.4-C2-C3-C4 by boiling them in water for 10 minutes; use demineralised or distilled water to prevent calcium deposits.

method C: Sanitise the accessories C1.1-C1.2-C1.3-C1.4-C2-C3-C4 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).

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

AIR FILTERING

The unit is equipped with an air filter (A3) which should be replaced when dirty or when its colour changes. To replace the filter take it out by pulling it as shown in figure. The filter is designed to remain fixed in its housing.

Do not replace the filter during use.

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

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AVAILABLE SPARE PARTS

Description Code

- (C1 - RF6 Basic^2 nebuliser) + (C2 - Mouthpiece)	ACO369P
- (C3 - Adult mask) + (C4 - Child mask)	ACO462P
- B Connection tube	ACO35
- 2 (A3 - Air filter)	ACO439P

TROUBLESHOOTING

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

PROBLEM CAUSE SOLUTION
The device does not work	The power cable has not been correctly inserted into the power socket	Correctly insert the power cable in sockets.
The device does not nebulize or nebulizes insufficiently.	The medication has not been inserted in the nebulizer	Pour 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 clogged	Disassemble 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 device	Ensure the device's accessories are properly connected to the air intake (see connection diagram on the cover).
	The air pipe is bent, damaged or twisted	Unwind 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 usual	The Filter is not correctly inserted in its housing	Fully 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

Certification TÜV

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

Class II device Manufacturer

Important: check the operating instructions

Switch "ON"

When you shut off the device, the switch will interrupt the compressor function only on one of the two power phases

Compli

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

Minimum and maximum room temperature

Minimum and maximum atmospheric pressure

Serial number of device

Type BF applied part

Alternating current

IP21

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

Minimum and maximum air moisture

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 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.

TECHNICAL FEATURES

Mod. P0211EM F400

Voltage: 230V~50Hz 130VA 115V ~ 60Hz 220V ~ 60Hz
Safety certifications:

Max pressure: 1.8 ± 0.3 bar Compressor air output: 9 l/min approx Sound level (at 1 m): 54 dB (A) approx Operation: Continuous

Operating conditions:

Temperature: min 10°C; max 40°C RH Air humidity: min 10%; max 95% Atmospheric pressure: min 69KPa; max 106KPa

Storage conditions:

Temperature: min -25°C; max 70°C RH Air humidity: min 10%; max 95% Atmospheric pressure: min 69KPa; max 106KPa Dimensions (W)x(D)x(H): 13.5x15.5x11 cm Weight: 1.100 Kg

APPLIED PARTS

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

RF6 Basic ^2 nebuliser

Medication minimum capacity: 2 ml Medication maximum capacity: 8 ml Operating pressure (with neb.): 0.6 bar

MMAD (μm)^(2)		BREATHABLEFRACTION< 5 μm (FPF) ^(2)		DELIVERY ml/min^(1) (approx)
Standard mode	High speed mode	Standard mode	High speed mode	Standard mode	High speed mode
3.8 4.0 62% 63% 0.25 0.32

(1) Data detected according to Flaem I29-P07.5 internal procedure. (2) In vitro characterization carried out at the Inamed Research GmbH & Co. KG on behalf of TÜV Rheinland Product Safety GmbH – Germany in compliance with the European Standard for aerosol therapy appliances, Standard EN 13544-1. Further details are available upon request.

DISPOSAL OF DEVICE:

In conformity with Directive 2012/19/EC, the symbol shown on the device to be disposed of indicates that it is considered as waste and is therefore subject to "sorted waste collection". The user must therefore take (or have taken) the above waste to a pre-sorted waste collection centre set up by the local authorities, or else give it back to the dealer when purchasing a new appliance of the same type. Pre-sorted waste collection and the subsequent treatment, recovery and disposal operations favor the production of appliances made of recycled materials and limit the negative effects of any incorrect waste management on the environment and public health. 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.

Ghibli Plus

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"high speed"

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"modalité standard"

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PIÈCES DE RECHANGE DISPONIBLES

Description Code

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): 13,5x15,5x11 cm Poids: 1,100 Kg

PARTIES APPLIQUEES

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

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"modo high speed"

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Material biocompatible blando

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Operating pressure ^(1) (with neb.) 0,6 bar.

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CZEŚCI

Описание кода

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更换过滤器时：

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