Helios - Inhaler Magic Care - Free user manual and instructions

Product Type	Inhaler / Nebulizer
Brand	Magic Care
Model	Helios
Dimensions (approx.)	15 x 10 x 10 cm
Weight (approx.)	300 g
Power Supply	AC adapter (100-240V) or 4 AA batteries
Output Type	Compressed air nebulizer
Medication Capacity	Up to 10 ml
Particle Size	Approximately 3-5 microns
Nebulization Rate	Approximately 0.3 ml/min
Noise Level	< 55 dB
Accessories Included	Face mask, mouthpiece, air tube, medication cup, filter
Cleaning Method	Disassemble and wash with warm soapy water; air dry
Filter Replacement	Every 3-6 months or as needed
Safety Features	Auto shut-off, overheat protection
Operating Environment	Temperature: 10-40°C, humidity: 30-85%
Storage Conditions	Dry, clean place, away from direct sunlight
Warranty	2 years
Certifications	CE, FDA registered

Frequently Asked Questions - Helios Magic Care

How do I use the Helios inhaler?

1. Wash hands. 2. Assemble the nebulizer: connect the tube to the compressor and medication cup. 3. Place the prescribed medication into the cup. 4. Attach the mouthpiece or mask. 5. Turn on the compressor. 6. Breathe normally until medication is consumed. 7. Turn off and disassemble for cleaning.

How do I clean the inhaler after use?

Disconnect the tube and disassemble the medication cup, mouthpiece, and mask. Wash these parts with warm soapy water, rinse thoroughly, and let them air dry. Do not clean the compressor or tube with water. Wipe the compressor with a damp cloth.

How often should I replace the air filter?

Replace the air filter every 3-6 months or when it appears dirty. A clogged filter can reduce performance. Refer to the user manual for the exact location and replacement procedure.

Can I use essential oils in the Helios inhaler?

No, the Helios is designed for aqueous solutions only, such as saline or prescribed medications. Using oils can damage the device and is not recommended.

Why is there no mist coming out?

Check that the medication cup is properly assembled, the tube is connected, and the compressor is on. Also verify that the air filter is not clogged. If the problem persists, contact customer support.

Can I use the inhaler while lying down?

It is recommended to use the Helios in an upright seated position to ensure proper medication delivery and to avoid leakage. Using it lying down may reduce efficiency.

How long does one treatment session take?

A typical session takes about 10-15 minutes, depending on the volume of medication and the nebulization rate. The device will continue until the medication cup is nearly empty.

What should I do if the device gets hot?

The Helios has overheat protection. If it becomes too hot, it will automatically shut off. Allow it to cool down for at least 30 minutes before restarting. Ensure the air vents are not blocked.

Is the Helios inhaler suitable for children?

Yes, the Helios can be used for children with the appropriate mask attachment. Always supervise children during use. Consult a pediatrician for dosage and usage guidelines.

Where can I find replacement parts?

Replacement parts such as medication cups, masks, and filters can be purchased from authorized dealers or online retailers. Use only genuine Magic Care parts to ensure compatibility and safety.

USER MANUAL Helios Magic Care

Illustration of two people using nasal cannulas, one with a mask and the other holding a test tube (no text or symbols present)

Technical line drawing of a mechanical component with bolts and a central knob (no text or symbols)

We are pleased you have purchased our product and we thank you for your trust in us. Our goal is to fully satisfy consumers by offering them cutting-edge systems for the treatment of respiratory tract ailments. Carefully read these instructions and keep them in a safe place for future reference. Read these instructions carefully and retain them for future reference. Only use the accessory as described in this manual. This is a medical device to nebulise and administer medication prescribed or recommended by your doctor. Please note that the full range of products is visible on the website www.flaemnuova.it

STANDARD EQUIPMENT INCLUDES:

A - Aerosol apparatus (main unit)

A1 - On/Off switch

A2 - Air intake

A3 - Air filter

A4 - Nebuliser holder

A5 - Handle for transport

A6 - Power cable

C - Accessories

C1 - RF8 Nebuliser

C1.1 - Lower part

C1.2 - Upper part

C1.3 - Drugsaver

C2 - Mouthpiece

C3 - Pediatric nose piece

C4 - Adult SoftTouch mask

B - Connection tube (main unit / nebuliser)

D - Pochette for accessories

IMPORTANT WARNINGS

• 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.
• 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.
• The device casing is not waterproof. 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 must be carried out only by FLAEM authorised personnel. Unauthorised repairs void the warranty and may be hazardous for 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 to report problems and/or unexpected events related to operation.

OPERATING INSTRUCTIONS

Before each use, wash your hands accurately and clean the device as described in the paragraph "CLEANING SANITISATION DISINFECTION".

The nebuliser cup and accessories are for personal use only to avoid potential risks of transmitting infection.

During application, it is advisable to suitably protect yourself from any dripping.

1. Plug the power cable (A6) into mains socket that is compatible with the device voltage. The position of the socket must be such that the device can be easily unplugged from the mains network.

2. Pour the medication prescribed by the doctor into the lower part (C1.1). Insert the upper part (C1.2) into the lower part (C1.1), close the nebuliser by turning the upper part (C1.2) clockwise. Insert the Drugsaver (C1.3) as shown in the "Assembly diagram" in point C1.

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

4. 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).

5. Start the device by means of switch (A1) and breathe deeply in and out. After inhaling, we recommend

Line drawing of two individuals wearing face masks, one holding a test tube (no text or symbols present)

holding your breath for an instant to allow the inhaled drops of aerosol to deposit. Then exhale slowly.

1. Upon completing application, switch off the device and unplug it.

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

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 AND TUBING EXTERIOR

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 (C1.2) anticlockwise, remove the upper part (C1.2 and C1.3) as shown in the "Assembly diagram" in point C1.

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-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-C2-C3-C4 in the dishwasher with a hot cycle.

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

method C: Disinfect the accessories C1.1-C1.2-C1.3-C2-C3 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).

REPLACING THE FILTER

The device has a suction filter (A3) that should be replaced when it is dirty or changes color. Do not wash or reuse the same filter. Regular replacement of the filter is required to help and ensure correct performance of the compressor. Check the filter on a regular basis. Contact your local dealer or authorized service center for spare filters.

Technical line drawing of a mechanical component with gears and a central knob (no text or symbols)

To replace the filter take it out by pulling it as shown in figure. The filter has been designed so that it is always fixed in its seat. Use original FLAEM accessories only.

SYMBOLS

TÜV approval ref. EN 60601-1 3rd Ed. - EN 60601-1-11

EC Marking medical ref. Dir 93/42 EEC and subsequent updates

Class II device Manufacturer

Attention: check the instructions for use

Switch "ON"

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

Switch "OFF"

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

Minimum and maximum ambient temperature

Minimum and maximum air pressure

Device serial number

Type BF applied part

Alternating current

Risk: electrocution.

Consequence: Death. Using the device while taking a bath or shower is prohibited

IP21

Degree of protection of the casing: IP21.

(Protected against solid foreign objects larger than 12 mm. Protected against access with a finger; Protected against vertically dripping water).

Minimum and maximum humidity

ELECTROMAGNETIC COMPATIBILITY

This device was designed to satisfy the currently required requisites for electromagnetic compatibility (EN 60601-1-2:2007). 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, in particular with other analysis and treatment 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. Flaem reserves the right to make technical and functional modifications to the product with no prior warning.

TECHNICAL FEATURES

Mod. P0211EM F400

Voltage:	230V~50Hz130VA	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):	13.5 x 15.5 x 11 cm
Weight:	1.100 Kg

APPLIED PARTS

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

RF8 nebuliser

Medication minimum capacity:	2 ml
Medication maximum capacity:	8 ml
Operating pressure (with neb.):	0.8 bar

(1) Delivery: 0.40 ml/min approx.
(2) MMAD: 4.48 μm
(2) Breathable fraction < 5 μm (FPF): 55.5%
(1) data recorded according to internal Flaem procedure I29-P07.5.(2) In vitro characterization certified by TÜV Rheinland LGA Products GmbH - Germany in compliance with European Standard for Aerosol therapy apparatuses EN 13544-1. Further details are available on request.

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.

MAGICCARE

IL VERO BENESSERE

HEALTHCARE AT HOME

FLAEM NUOVA S.p.A.

Via Colli Storici, 221

25015 S. MARTINO DELLA BATTAGLIA

(Brescia) - ITALY

Tel. [phone] r.a.

Fax [phone]

www.flaemnuva.it

2016 FLAEM NUOVA®

All right reserved

cod. 17334 Rev. 11/2016

(TÜV 4)