PORTABLE NEBULISER USER MANUAL - Trifectiv Plus

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                                                PORTABLE

                              HEALTH
                                                NEBULISER

                              USER MANUAL
                                       MODEL: NEB04

                       Superfine         Battery / USB   Nebulise Any Time /
                   Atomising Particles     Powered           Any Place
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TABLE OF CONTENTS

            Introduction.  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  . 3

            Intended use .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  . 4

            Safety precautions.  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  . 5

            Classification and explanation of symbols.  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  . 6

            Package contents and overview.  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  . 7

            How to operate with batteries .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  . 9

            How to operate with adapter.  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  . 11

            Cleaning and disinfection .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  . 12

            Troubleshooting.  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  . 15

            Specifications.  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  .  . 16

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INTRODUCTION
            The mx™ Portable Nebuliser is a hand held device designed to assist with the
            treatment of respiratory conditions. The device uses Active Vibrating Mesh
            Technology, which works by converting medication prescribed by a medical
            physician into an aerosol of microscopic droplets that can be inhaled into the
            lungs.

            The device is compact, portable, lightweight, and comes in a handy carry
            bag making it ideal to use at home or to use whilst travelling. The nebuliser
            can be powered via two AA batteries (not included), or via a USB connection
            (included) which can be plugged into an electrical connection via a simple
            plug.

            The nebuliser is super quiet and is fully operational from any angle.

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INTENDED USE

                                                             The mx™ Portable Nebuliser is a hand
                                                             held device designed to assist with the
                                                             treatment of respiratory conditions.
                                                             The device uses Active Vibrating Mesh
               Medical purpose                               Technology, which works by converting
                                                             medication prescribed by a medical
                                                             physician into an aerosol of microscopic
                                                             droplets that can be inhaled into the
                                                             lungs.
                                                             This device can be used by patients of
                                                             all ages.
                                                             It should not be used on patients
               Intended patients                             who are unconscious, not breathing
                                                             spontaneously or suffering from a
                                                             pulmonary edema.
                                                             This device is ideal for home use or
                                                             whilst travelling.
               Recommended operation environment             Temperature range:
                                                             10°C to 40°C
                                                             Humidity: 30 to 85 % RH
                                                             Main unit             24 months
               Durable period
                                                             Medication cup        12 months
                                                             Warnings and cautions described in the
               Precautions for use                           manual should be observed properly.

              Should the desired results not be achieved with correct nebulising of the patient,
              please consult your healthcare professional.

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SAFETY PRECAUTIONS
                   READ ALL WARNINGS AND INSTRUCTIONS BEFORE YOU USE THIS DEVICE.

            As with any medical device, this product may become unusable due to an electrical
            outage, battery depletion or mechanical impaction. We recommend that you have
            spare batteries and a backup device available.
            When you use electrical products, always follow basic safety precautions.
            As with any electrical device take particular care around children.

                                                      WARNINGS

            Only use this device for medications prescribed by your doctor.
                   • The nebuliser is only intended for respiratory therapy and any other
                     application of this device is improper and dangerous. The manufacturer
                     cannot be held liable for any damage caused by improper or incorrect
                     use.
                   • Do not share your nebuliser with others. It is intended to be used by
                     a single user only. If more than one person uses it, there is a risk of
                     spreading infectious illness.
                   • Clean all parts of your nebuliser before use, after each use and after
                     extended storage.
                   • Adult supervision is required when this device is used by children and
                     individuals who require special assistance.
                   • Never operate this device if any of the parts are not working properly or
                     have been damaged.
                   • Be sure the device has been properly cleaned before use to avoid possible
                     contamination.
                   • Do not plug in or unplug the Adapter from the electrical outlet with wet
                     hands.
                                                       CAUTIONS

                   • Do not attempt to clean the nebuliser or accessories with any foreign
                     objects.
                   • Avoid dropping the device otherwise it may not function normally.
                   • Keep the device away from direct sunlight, excessive heat or cold to avoid
                     damaging the batteries.
                   • Do not attempt to open, repair or modify this device.
                   • Do not drop any liquids on the main unit or on the Adapter, if you drop
                     liquids on it, wipe off immediately.
                   • Follow local laws and recycling plans regarding disposal or recycling of
                     components, batteries and packaging.

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CLASSIFICATION AND EXPLANATION OF SYMBOLS

                    Symbols                 Meaning

                                            Warning / Caution / Note

                                            Class II equipment

                                            Type BF equipment

                                            Consult instructions for use

                                            ON / OFF Button

                                            DC Power source (Direct Current)
                                   40°C
                          10°C
                                            Operating temperature limits : 10° to 40°
                                   70°C
                         -20°C
                                            Storage and delivery temperature limits : -20° to 70°
                                      85%
                                            Operating humidity limits: 30 to 85% R.H.
                         30%
                                      80%
                                            Storage and delivery humidity limits: 20 to 80% R.H.
                         20%

                                            Manufacturer

                                            Date of manufacture

                                 SN         Serial number

                                 LOT        Batch code

                                            Disposal of Electrical & Electronic Equipment
                                            (WEEE): Do not treat this product as a household
                                            waste.
                                            This device complies with the requirements of the
                                 - 0473     Medical Devices Directive
                                            Authorized representative in the European
                           EC REP           Community

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PACKAGE CONTENTS
            Check before use
            The following items should be included in the box. Please check all parts for
            visible damage. Replace any damaged parts before you use this device.
            In case of missing parts, malfunction or damage, please contact the
            store, or nearest dealer where you made your purchase.

             Nebuliser unit         Medication cup        Power adapter
                                    (with cover)          (The adapter might differ
                                                          from that shown above.)

                                                          Please choose DC
                                                          5V/1A adapter, and
                                                          the connection jack
                                                          should match a plug
                                                          with outer diameter
                                                          of 3.5mm, interior
                                                          diameter of 1.35mm,
                                                          9.5mm in length and
                                                          positive polarity.

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OVERVIEW

                                          Medication Cup Cap

                                          Medication Cup

                                          Mesh

                                          Mouthpiece

                                          ON / OFF Button
                                          Press ON / OFF Button
                                          to turn on the power.

                                          Electrode

                                          Medication Cup Release Button
                                          Power Indicator•

                                          Press Release Button to remove the
                   Main Unit              medication cup.

                               Light indications
                               Green light on: During operation
                               Orange light flash: Low power / Malfunction
                               No light: Malfunction

                                                                     Battery Cover

                               Bottom view (Model no. NEB04)

                                                      Power Cable Jack

                                                      Power Cable Jack Cover

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HOW TO OPERATE WITH BATTERIES
            This device can operate on two batteries

                    Clean all parts of your portable nebuliser before use,
                    after each use and after extended storage.

                                                       1. Insert the batteries
                                                          - Turn the unit upside down,
                                                          - Push back and pull up the
                                                       		 battery cover to open it.
                                                          - Insert two batteries
                                                       		 according to the battery
                                                       		 polarity indicated inside the
                                                       		 battery compartment.
                                                          - Put down and push forward
                                                       		 the battery cover to lock it.

                                                       2. Set up the medication cup
                                                          - Align the three ribs on the
                                                       		 back of the medication cup
                                                       		 with three trenches of
                                                       		 the main unit to insert the
                                                       		 medication cup into the main
                                                       		unit.

                     Do not use old and new batteries together or mixing
                     batteries using differing cell chemistries.

                                                        3. Fill the saline / medication
                                                          Make sure that indicator light is
                                                          off before adding the saline /
                                                          medication.
                                                          - Open the medication cup cap.
                                                          - Fill the medication cup with
                                                        		 saline and or medication.
                                                        		DO NOT EXCEED THE LIMIT.
                                                        		 (Max. of 6ml).
                                                         - Close the medication cup cap
                                                  9     		 properly.

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4. Inhalation
                                                      - Place the mouthpiece
                                                    		 between your teeth, with
                                                    		 your lips firmly sealed around
                                                    		 the mouthpiece.
                                                      - Press ON/OFF button on the
                                                    		 top to turn on the device
                                                    		 (light Indicator turns green).
                                                      - Breathe in and out slowly
                             ON / OFF Button        		 through your mouth until
                                                    		 aerosol formation stops.

                                                    5. End of Inhalation
                                                       - Press ON/OFF button to turn
                                                    		 it off.
                                                       - Remove the batteries from
                                                    		 the main unit.

                     1. Tilt the device slightly, while the solution is almost
                        exhausted to make sure that the residual solution contacts
                        the mesh and is sprayed completely.
                     2. If high-viscosity solution is used, nebulisation may be
                        reduced.
                     3. If excessive solution is accumulated on the mesh,
                        nebulisation may stop. In this case, turn off the power and
                        absorb the solution with gauze or a lint-free towel.

            Battery life and battery replacement
            1. Battery life is usually dependant on the capacity and condition of the
               batteries.
               In general, this device can operate about 4 days with two brand new
               batteries based on the usage of 20 minutes a day.
            2. When the power indicator turns orange (means low power), please
               replace both batteries with new ones.

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HOW TO OPERATE WITH ADAPTER
                    1. Please choose DC 5V/1A adapter (not included), and the
                       connection jack should match a plug with outer diameter of
                       3.5mm, interior diameter of 1.35mm, 9.5mm in length and
                       positive polarity.
                    2. The adapter does not charge batteries. Please remove the
                       batteries before using the adapter.
                    3. As with all electronic devices, it is recommended to keep
                       the product unplugged when not in use.

                                                     1. Set up the medication cup.
                                                        - Align the three ribs on the
                                                     		 back of the medication cup
                                                     		 with three trenches of the main
                                                     		 unit to insert the medication
                                                     		 cup into the main unit.

                                                     2. Add medication / saline
                                                        - Open the medication cup cap.
                                                        - Fill the medication cup with
                                                     		 prescribed medicine / saline.
                                                     		DO NOT EXCEED THE LIMIT.
                                                     		 (Max. of 6ml).
                                                       - Close the medication cup cap
                                                     		 properly.

                                                     3. Connect with adapter.
                                                        - Plug the cable into the power
                                                     		 adapter jack on the main unit.
                                                        - Plug the adapter into a
                                                     		 standard electrical outlet.
                                                     *The adapter may differ from that shown here.

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4. Inhalation
                                                       - Place the mouthpiece
                                                     		 between your teeth, with
                                                     		 your lips firmly sealed around
                                                     		 the mouthpiece.
                                                       - Press ON/OFF button on the
                                                     		 top to turn on the device
                                                     		 (light Indicator turns green).
                                                       - Breathe in and out slowly
                             ON / OFF Button         		 through your mouth until
                                                     		 aerosol formation stops.

                                                     5. End of Inhalation
                                                        - Press ON/OFF button to turn
                                                     		 it off.
                                                        - Remove the batteries from
                                                     		 the main unit.

            CLEANING AND DISINFECTION

                     If the device is not cleaned and disinfected correctly and
                     frequently as indicated, microorganisms may remain in the unit
                     and cause risk of infection.

            After every use: Clean the medication cup with distilled water after each
                             inhalation.

            1. Pour out the residual solutions from the medication cup.
            2. Pour some distilled water into the medication cup.
            3. Turn on the device to nebulise the distilled water for 1 to 2 minutes to
               clean the nebuliser.
            4. Remove batteries or disconnect the adapter from the main unit.
            5. Remove the medication cup from the nebuliser unit.
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6. Wash and rinse the medication cup with distilled water.
            7. Shake off excess water and allow parts to be fully air dried on a clean,
               dry towel.
            8. Use gauze or clean towel to wipe off stains on the main unit if necessary.
            9. Make sure that all cleaned parts are completely dry before you store them
               or use them next time.

                      1. Keep the battery compartment dry all the times.
                      2. Do NOT poke the nebuliser with finger, cotton swab or any
                         objects.
                      3. Do NOT clean parts in a dishwasher.
                      4. Do NOT use a microwave to dry any parts.

            Daily disinfections: It is important to disinfect the medication cup on a daily
                                 basis.

            1. Disinfection using boiled water
               - Rinse the medication cup with distilled water.
               - Bring a saucepan of DISTILLED water to the boil.
                 NOTE: Do NOT boil medication in the cup directly
               - Carefully immerse the medication cup in the boiled water for a maximum
            		 of ten (10) minutes.
               - Carefully remove the medication cup from the boiled water and shake off
            		 excess water.
               - Allow parts to cool down and fully air dry on a clean, dry towel, out
            		 of reach of children.
               - Make sure that all cleaned parts are completely dry before you store
            		 them or use them again.
            2. Disinfection using alcohol
               - Rinse the medication cup with distilled water.
               - Immerse the medication cup in 75% ethyl alcohol for 1 minute.
               - Rinse the medication cup with distilled water again, shake off excess
            		 water and allow parts to be fully air dry on a clean, dry towel.
               - Make sure that all cleaned parts are completely dry before you store
            		 or use them again.

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Alcohol is highly flammable.
                     Do not use alcohol in close vicinity of open fire or smoke.

            The following items are able to be disinfected using boiled water or alcohol

                            Medication cup (with cover)

            Parts below are NOT to be disinfected using boiled water or alcohol

                                     Power adapter
           Nebuliser unit            (The adapter might differ from that shown above.)

                     Do NOT rinse or immerse the main unit in any liquid.

            CARRYING AND STORING
            Put on the mouthpiece cover, store the device and medication cup in a dry
            and clean environment.

                     1. Do NOT leave or carry the device containing residual liquid in
                        the medication cup.
                     2. Remove the batteries if device is not in use for long periods.
                        Failure to do so could result in damage due to battery leakage.
                     3. Do NOT expose the device to direct sunlight, high
                        humidity, or extreme heat or cold temperatures.
                     4. Keep this device away from fire, high electromagnetic fields
                        and out of the reach of children.

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TROUBLESHOOTING
            If any trouble occurs while you are using the device, please check the
            following lists first.
                                                                         Replace the batteries or use
                                         Low battery power               the power adapter
                                         Stains on the electrode cause Use alcohol to clean
                                         a faulty connection           electrodes
             Low atomisation                                           Refer to cleaning and
                                         The mesh holes are clogged disinfection procedure to clean
                                                                       the medication cup
                                         The mesh is broken              Replace the medication cup
                                                                         Follow (+) and (-) marks on
                                         The batteries are inserted in   the battery cover and re-insert
                                         the wrong direction             the batteries in the correct
             After switching on, the                                     direction
             power indicator is not on                                   Replace the batteries or use
                                         Batteries are flat
             and no mist comes out.                                      the power adapter
                                                                         Check and reconnect the
                                         Faulty connection between       power adapter to the nebuliser
                                         battery and main unit           unit
                                                                         Refer to set up the
                                         The medication cup is not       medication procedure to
                                         installed properly              re-install the medication cup.
             After switching on, the                                     Refer to cleaning and
             power indicator is on,      The mesh holes are clogged      disinfection procedure to clean
             but no atomisation.                                         the medication cup
                                         The mesh is broken              Replace the medication cup

             Power indicator is                                          Replace the batteries or use
                                         Low battery power
             constantly orange                                           the power adapter
                                                                         Use alcohol to clean
                                         Faulty connection of            electrodes and re-install the
             Power indicator is flashing electrode and main unit         medication cup
             orange
                                         The mesh is broken              Replace the medication cup

                       1. If the device does not nebulise normally after taking the
                          above-mentioned procedure, please contact the store where
                          you purchased the device or the nearest dealer.
                       2. Never operate this device if any of the parts are not working
                          properly or have been damaged.
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SPECIFICATIONS
            Product                                       mx™ Portable (Mesh) Nebuliser

            Model                                         NEB04

            Method of operation                           Active Vibrating Mesh Technology

            Power supply                                  AA Battery x 2 and Power Adapter

            Power consumption
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