MPV MEDICAL MicroDrop Pro2 Instruction Manual

Product Description

MicroDrop® Pro2

Professional inhalation for children and adults.

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 these instructions and keep them for future reference. Use the unit only as described in this instruction manual.

This is a medical device for home use and may only be used with medication prescribed or recommended by a doctor who has performed patient's evaluation.

Visit our Internet site www.mpvmedical.com to view the whole range of MPV MEDICAL products.

Complete Equipment

Pic. A: Aerosol Therapy Unit (Compressor)

Diagram showing the main unit. Key components labeled:

• 1. Aerosol therapy unit (Compressor)
• 2. On/off switch
• 3. Air outlet port
• 4. Air filter

Pic. B: Unit Details

Diagram showing the unit from a different angle. Key components labeled:

• 2. On/off switch
• 3. Air outlet port
• 4. Air filter

Pic. C: Unit with Accessories

Diagram showing the unit with carrying handle and connection tube. Key components labeled:

• 5. Carrying handle
• 6. Connection tube

Pic. D: Unit Base Details

• 7. Nebulizer holder
• 8. Cable compartment
• 9. Power cord

Pic. E: Complete Equipment of the MicroDrop® Pro2

Diagram showing the main unit and all included accessories. Key components labeled:

• 1. Soft child mask
• 2. Soft adult mask
• 3. Mouthpiece with valve
• 4. Speed selector with valve system
• 5. RF7 plus nebulizer
• 6. Expiratory valve
• 7. Trigger t-piece
• 8. Filter compressor
• 9. Connection tube

Components of RF7 plus Nebulizer

Pic. F: RF7 plus Nebulizer Parts

Diagram of the RF7 plus nebulizer. Key components labeled:

• 1. Upper part
• 2. Lower part
• 3. Complete nozzle
• 4. Speed selector with valve system

ℹ️ Info: Click complete nozzle (3) into the upper part (1).

Warranty Conditions

• The device is covered by a 5-year warranty as indicated on the packaging from date of purchase for any defects in the design or in the materials used.
• The warranty consists in the replacement and / or repair free of charge of originally defective components.
• The warranty does not cover the accessories supplied with the device and those parts subject to normal wear and tear.
• The device must be repaired by authorized technical service centres only.
• The device must be sent to the authorized service centre for repair within 8 days after the defect is noticed.
• Transport costs for the device are at user's charge.
• Any repair out of warranty conditions are at user's charge.
• The warranty does not cover failures resulting from misuse, abuse of the product or in case the damage is not due to manufacturer's liability (accidental fall, rough transportation, etc.).
• The warranty does not involve any compensation for any kind of damages to persons or things, either direct or indirect, occurred when the device is not operating.
• The warranty is valid from the date of purchase certified by the ticket or the invoice.

Important Safeguards

Before using the device for the first time, and periodically during the product's life, check the integrity of its structure and of the power cable, making sure that there is no damage; if it is damaged, do not insert the plug and take the product immediately to MPV MEDICAL or to an authorized local dealer.

• This Medical Device is intended also for patient's direct use.
• 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 effect.
• If the device is not performing according to the specification, please contact an authorized service centre or distributor.
• 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 specified 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 inflammable 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 centre or to your local dealer.
• Only use the device in dust-free environments; otherwise, therapy may be compromised.
• 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 particularly extreme temperatures.
• Do not put the device near heat sources, direct sunlight, or in hot environments.
• Do not obstruct or insert any objects in the filter or in its housing in the device.
• Do not obstruct the air vents placed on both sides of the unit.
• During use, always place the unit on a firm 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, including the replacement of the power cord, must be performed by authorized personnel only following the information provided by the Manufacturer. Any unauthorized repairs will void the warranty and may pose a safety hazard for the user.
• The average duration provided for compressor is: 1000 hours.

⚠️ Do not modify this equipment without authorization of the manufacturer.

• 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 medications, 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 and if necessary for clarifications on use, maintenance or cleaning.

Instructions for Use

Before each use, the nebulizer and accessories should be cleaned according to the instructions in the section "Cleaning, sanitization and disinfection". This device is intended to aerosolise drugs and solutions suitable for inhalation treatment to be prescribed by the doctor. If the drug or solution is too dense, dilution with suitable saline solution might be needed, as prescribed by the doctor.

1. Insert the power cord (Pic. D9) into a power socket corresponding to the voltage of the device. This must be positioned so that it is not difficult to disconnect it from the mains.
2. Open the nebulizer by turning the upper part (Pic. F1) anticlockwise.
3. Pour the drug prescribed by the physician into the lower part (Pic. F2). Close the nebulizer by turning the upper part (Pic. F1) clockwise.
4. Connect the accessories as shown in the "Assembly diagram". Sit comfortably, holding the nebulizer in your hands, place the mouthpiece over your mouth or use the mask.
5. If you use the face mask, fit it to the face as shown in the picture.
6. Start the unit by means of switch (Pic. A2) and breathe in and out deeply through the mouthpiece or mask.
7. When the treatment is finished, turn off the unit and disconnect the plug from the mains socket.
8. It may happen that after a treatment session visible humidity deposits form in the tube (Pic. C6): disconnect the tube from the nebulizer and let it dry using the compressor air flow, as this prevents mould from growing in the tube.

ℹ️ A personal use of the nebulizer and its accessories is recommended in order to avoid any risks of infection.

After every use, store the unit and the accessories in a dry and dust free place.

Assembly Diagram

Diagram showing how to assemble the nebulizer components. Numbers correspond to parts listed in "Complete Equipment".

Pic. 5: Mask Usage

Illustration showing how to fit the mask to the face.

How to Use the "RF7 Dual Speed Plus" Nebulizer with Speed Selector and Valve

The nebulizer is professional, fast, and suitable for the administration of all types of drugs, including the most expensive ones, also in patients with chronic diseases. The geometry of the internal ducts of the RF7 Dual Speed Plus nebulizer ensures the ideal particle size providing effective treatment right down to the lower airways.

Speed Selector Operation

Diagrams illustrating the speed selector (F4) on the nebulizer.

• MAX Setting: To make inhalation therapy faster, press with your finger on the MAX marking on the speed selector with valve system (F4).
• MIN Setting: To make inhalation therapy more effective, press with your finger on the speed selector with valve system (F4) opposite the MAX marking. In this way, the valve systems in the nebulizer, in the mouthpiece, and in the mask will ensure optimal medication delivery to the lower respiratory tract, limiting dispersion of medication into the environment.

Soft Touch Masks

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.

Illustration: A cross-section of a Soft Touch mask showing the soft biocompatible material and the Dispersion Limiting Device.

• 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.

Using the Manual Nebulization Control (Trigger T-piece)

The trigger t-piece is useful for limiting dispersion of the medication in the surrounding environment.

To achieve continuous nebulization action, you should not use the trigger t-piece (E7), especially in the case of children or persons with reduced physical, sensory, or mental capabilities.

Use your finger to block the hole of the trigger t-piece (E7) and take a slow deep breath; it is advisable to hold your breath for several seconds so that the inhaled aerosol droplets can settle. In the meanwhile, take your finger off the hole on the trigger t-piece for optimal assimilation of the medicine. Then exhale slowly.

Cleaning, Sanitization and Disinfection

Clean the nebulizer and accessories as described below before and after each use. Disinfect/Sanitize at least once a day. Personal use of the nebulizer and its accessories is recommended to avoid the risk of infection.

1. Preparation

Open the nebulizer by turning the upper part (Fig. F1) counterclockwise. Pour away any remaining medication. Disconnect the nozzle from the top of the nebulizer (Fig. F1). Remove the mouthpiece or mask from the nebulizer. Rinse these parts under running water.

2. Cleaning

Outer surface of the compressor and tubing: Use only a slightly damp cloth with an antibacterial detergent (non-abrasive and solvent-free).

3. Sanitization

Method A (warm water or dishwasher)

Nebulizer and accessories: Clean the accessories E1, E2 (without rubber band), E3, E4, E5 for about 5 minutes in warm water (about 40° C) and with mild (non-abrasive) detergent. Or put the parts in the dish rack of your dishwasher and start a 70°C hot rinse program. Do not use the dishwasher in combination with dirty dishes when cleaning the nebulizer.

Method B (vinegar solution)

Clean accessories E1, E2 (without rubber band), E3, E4, E5 by soaking in a solution of 50% water and 50% white vinegar for about 60 minutes. Then rinse thoroughly with warm tap water (about 40°C).

4. Disinfection

THERMAL DISINFECTION

Method A (boiling water)

Disinfect the accessories E1, E2 (without rubber band), E3, E4, E5 by boiling in water for 20 minutes (do not boil the tubing!) - preferably with distilled or demineralized water to prevent limescale. Please add enough water to the pot to prevent the nebulizer parts from melting by touching the bottom of the pot. After boiling, shake out the accessories and place them on a paper towel or kitchen towel, or dry with a warm jet of air (such as a hairdryer).

Method B (baby bottles vaporiser)

Disinfect the accessories E1, E2 (without rubber band), E3, E4, E5 with a steam sterilizer for baby bottles (do not use microwave sterilizers). Perform the process exactly as directed by the sterilizer manufacturer's manual. To ensure that the disinfection is effective, choose a sterilizer with a cycle of at least 6 minutes.

CHEMICAL DISINFECTION

Disinfectable accessories are E1, E2 (without rubber band), E3, E4, E5.

The disinfection procedure described in this section should be performed before using the accessory. Disinfection is only successful if every step is followed carefully and the components have been cleaned beforehand.

Note:

1. Use a container of a suitable size to house all the components to be disinfected. Fill it with a 2% -5% sodium hypochlorite solution. Please strictly follow the instructions of the disinfectant manufacturer, especially regarding safety instructions, concentration, dosage and exposure time. Ready-to-use solutions that you do not need to mix yourself can be bought on the internet or in pharmacies.
2. Immerse each component completely in the solution. Make sure that there are no air bubbles. These would prevent the disinfectant coming into contact with the components. The disinfection would not be completely possible.
3. Remove the disinfected components after the exposure time and rinse thoroughly with warm drinking water. After disinfecting, shake out the accessories and place them on a paper towel or kitchen towel, or dry them with a warm jet of air (such as a hairdryer). Dispose of the disinfectant solution according to the manufacturer's instructions.

AUTOCLAVING / STERILIZATION (134 °C)

Accessories E1, E2 (without rubber band), E3, E4, and E5 can be sterilized.

Sterilization device: fractionated vacuum overpressure steam sterilizer according to EN 13060.

Procedure: Place each individual part to be treated in a sterile barrier system that meets the requirements of EN 11607. Place the packaged components in the steam sterilizer. Proceed the sterilization with a cycle of 10 minutes and a temperature of 134°C according to the operating instructions of the device.

Storage: Store the sterilized parts according to the instructions for use of the sterile barrier system.

The sterilization procedure has been validated in conformity with ISO 17665-1.

⚠️ Use original manufacturer accessories and spare parts only. The manufacturer will not be liable if non original accessories or spare parts are used.

Compressor Filter and Changing of the Compressor Filter

The compressor is equipped with an air inlet filter (Fig. B4), which filters out the aspirated air before it enters the unit. Dust and dirt particles do not get into the inhaled air from the nebulizer. Therefore, it is important to replace the filter as soon as it is dirty or takes on a different color.

Remove the filter from the compressor by simply pulling it outwards. Insert the new filter firmly into the opening provided in the compressor (Pic. B4).

Pic. B: Filter Replacement

Diagram showing the location of the filter (4) on the compressor unit.

Do not wash the filter and do not use it again. The regular inspection and replacement of the filter helps to ensure the perfect performance of the compressor. Do not remove the filter during operation of the device.

Trouble Shooting

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

Problems and Solutions

Disposal

In conformity with Directive 2012/19/EC, the symbol shown on the appliance to be disposed of indicates that this is considered as waste and must therefore undergo "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 favour 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 in which the product is disposed of.

Electromagnetic Compatibility

This device has been designed to satisfy requirements currently required for electromagnetic compatibility (EN 60 601-1-2:2015). Electrical medical devices require special care. During installation and use with respect to EMC requirements, it is therefore required that they be installed and/or used according to the manufacturer's specification. Potential risk of electromagnetic interference with other devices, in particular with other devices for diagnosis and treatment.

Radio and mobile telecommunications devices or portable RF (mobile phones or wireless connections) may interfere with the operation of electrical medical devices. The manufacturer reserves the right to make technical and functional changes to the product without notice. For additional information please visit www.mpvmedical.com.

Technical Data MicroDrop® Pro2 (Mod. P1207EM F1000)

General Specifications

• Voltage: 230V~ 50Hz 140VA
• In conformity with: 93/42/EWG, CE0051
• Max Pressure: 2.6 ± 0.4 bar
• Compressor air output: 10 LPM approx.
• Noise level (at 1 m): 54 dB (A) approx.
• Operation: Continuous use
• Dimensions (W)x(D)x(H): 170 mm x 200 mm x 105 mm
• Weight: 1.2 kg

Applied Parts

Type BF applied parts include:

• E1 - Soft child mask (PP + TPE)
• E2 - Soft adult mask (PP + TPE)
• E3 - Mouthpiece with valve (PP + silicone)
• E5 - RF7 plus nebulizer (PP + silicone)
• C6 - Connection tube (PVC phthalates free)

RF7 plus nebulizer

• Medication minimum fill volume: 2 ml
• Medication maximum fill volume: 8 ml
• Operating pressure (with neb.): 1.00 bar approx.
• Delivery rate (min): 0.23 ml/min
• Delivery rate (max): 0.53 ml/min

In vitro testing certified by TÜV Rheinland LGA Products GmbH – Germany in compliance with the European Standard EN 13544-1 for nebulising systems. Values gathered with mouthpiece. Further details are available upon request.

Performance Data

• MMAD: MIN 2.76 µm / MAX 2.91 µm
• Fine Particle Fraction < 5 µm: MIN 78.5 % / MAX 76.0 %

Operating conditions

• Temperature: min. 10° C; max. 40° C
• RH Air humidity: min. 10%; max. 95 %

Storage conditions

• Temperature: min. -25° C; max. 70° C
• RH Air humidity: min. 10%; max. 95 %
• Operating/storage atmospheric pressure: min. 69 KPa; max. 106 KPa

Symbols

Class II unit

Type-BF applied parts

Important: check the operating instructions

Alternate current

TÜV Certification

Switch OFF

Switch ON

Hazard: electrocution. Consequence: Death

Do not use device while taking a bath or shower

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

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

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

Minimum / Maximum Temperature

Minimum / Maximum Humidity

Minimum / Maximum Atmospheric pressure

Ordering Information

MicroDrop® Pro2

Professional nebulizer for children and adults

REIMBURSEMENT NUMBER 14.24.01.0121

Including: Compressor, RF7 plus nebulizer, Soft-children and -adult mask, mouthpiece, tubing, trigger T-piece compressor filter, carrying bag, manual

MicroDrop® profi nebulizer kit universal

Including: RF7 plus nebulizer, mouthpiece with exhalation valve, Soft-children and -adult mask, tubing, Universaladapter (for connection to other compressors*), compressor filter, manual

MicroDrop® profi nebulizer kit universal

Including: RF7 plus nebulizer, mouthpiece with exhalation valve, Soft-children and -adult mask, tubing, Universaladapter (for connection to other compressors*), compressor filter, manual

MicroDrop® RF7 plus profi nebulizer with mouthpiece and exhalation valve

MicroDrop® RF6 plus / RF7 plus mouthpiece with exhalation valve

* Please note that there are manufacturers for nebulizers whose do not allow the combination of Year-Sets or nebulizer accessories from another manufacturer! ** PZN = German REF number in pharmacies

MicroDrop® Pro2 nozzle for RF7 plus nebulizers

MicroDrop® RF7 plus soft-mask adults

blue / transparent with rubber band

MicroDrop® RF7 plus soft-mask children

blue / transparent with rubber band

MicroDrop® tubing 2 m

with 2 Fits-all-connector BPA free

MicroDrop® Pro2 compressor

incl. power cord

MicroDrop® 2 Filter compressor

1 piece for new compressor series

MicroDrop® Pro2 trigger t-piece

manually trigger t-piece

MicroDrop® 2 carrying bag

blue

Compliance and Manufacturer Information

CE 0051

Dieses Gerät entspricht den Bestimmungen der EU Richtlinie 93 / 42 / EEC und nachfolgenden Änderungen. THIS DEVICE FULFILS THE PROVISIONS OF THE EC DIRECTIVE 93 / 42 / EEC AND SUBSEQUENT MODIFICATIONS.

Hersteller / MANUFACTURER (93 / 42 / EEC): Designed und entwickelt von: DESIGNED AND ENGINEERED BY:

FLAEM NUOVA S.p.A., Via Colli Storici, 221-223-225, 25015 S. Martino della Battaglia – Brescia (Italy)

Entsorgung über eine Sammelstelle oder durch Zurücksendung an MPV MEDICAL.

Vertrieb / Distributor:

MPVMEDICAL

Parsdorfer Weg 6

85551 Kirchheim b. München

GERMANY

Tel. +49 (0)89-7299 700-0

Fax +49 (0)89-7299 700-99

www.mpvmedical.com

info@mpvmedical.com

14919C0 - Rev.02/2019 (TÜV A1)