Naweti WH202 Portable Nebulizer with Mesh Technology Instruction Manual

PORTABLE NEBULIZER
WITH MESH TECHNOLOGY
Model: WH202

SYMBOL KEY

The following symbols appear in the instructions for use and on the appliance and its packaging.
Warning – Warning regarding possible risk of injury or possible health hazards.
Note – Note providing importantinformation.
The packaging is made of renewable material and can be recycled.
Serial number.
Please read this manual carefully before using.
According to the degree of protection against direct and indirect con- tacts, the following equipment is classifiedasa BF type.
Dispose of in compliance with the provisions of Directive 2012/19/EU re- garding waste electrical and electronic equipment.
CE label certifies that the device is compliant with the basic requirements set out in the legislation concerning the safety on medical devices.
IP22 Degree of protection of electrical equipment covers, where the first number indicates the degree of protection against penetration by solid foreign bodies(from 0 to 6) andthe second number the degree of protection against liquid penetration (from 0 to 8).

SECURITY WARNING

**** Before using the appliance, read the instructions for use carefully, paying particular attention to the warnings regarding safety, which must be observed. This manual must be considered part of the product and must be kept for its entire life-cycle.
If the appliance is passed on to another owner, it must be provided together with all the relevant documentation. If the manual is mislaid or for further information or clarification, please contact Farmamed using the details provided on the last page.

• Before using the product, check that it is intact and has no visible damage. If you have any doubts, do not use the appliance and contact your retailer.

• This appliance must be utilised for its intended use only and as described in the instructions for use. Any other use is to be considered improper and, therefore, potentially dangerous. The manufacturer declines all responsibility for any damage caused by  incorrect or improper use.

• The accessories mentioned inthe user manual are intended for use with this device alone.

• To prevent cross infection, the device is used only by a single patient.

• This nebuliser is a medical device. Only follow your doctor’s instructions regarding the type and dose of the medicinal product to be used.

• The nebulisation cycle lasts 10-20 minutes, during which time the device nebulises 1-8 ml of medicinal product; however, is must be always used as indicated by a doctor.

• Keep the device out of the reach of babies and unsupervised children.

• In the event of a fault and/or malfunction, switch the appliance off without tampering with it. Always contact your dealer when repair work is required.

• Do NOT try to dismantle, repair or replace parts of this device yourself.
  Treat the appliancewithcare, protect itfrom blows, extremetemperaturechanges, humidi- ty, dust, direct sunlight and sources of heat.

• Do NOT shake the device during use.

• Do NOT allow liquids to penetrate inside the body of the appliance. Never immerse the appliancein water. Never rinse it under running water. This appliance is not waterproof.

• To avoid damage to the device, do not transport it or leave the medicinal product vessel full of medicinal product or distilled water, when not in use.

• Donotuseor store the device in humid places. Use the device within the temperature and humidity ranges included in “Product specifications”.

• Do not use any high concentration or high viscosity liquids, as these may damage the mesh irreparably.

• Do not use any medicines in powder form (even if dissolved.).

• Unplug from the socket after using the adapter.

• Switch the unit off immediately if it is defective or malfunctioning.

WARNINGS ON BATTERY USE

• If the appliance is not to be used for along period, remove the batteries and store inacool, dry place at roomtemperature.

• Please do not charge the nebulizer with the battery in it.

• NEVER expose batteries to sources of heat and direct sunlight. Failure to observe this precaution may damage the batteries and/or cause them to explode.

• Do NOT incinerate batteries. Risk of explosion!

• Use batteries of the same type and replace them at the same time.
  Batteries must be removed or replaced by an adult.

• Keep batteries out of the reach of children: swallowing batteries can be fatal. Ifswallowed, seek medical advice immediately.

• The acid inside the batteries is corrosive. Avoid contact with skin, eyes and clothing. If the battery liquid comes into contact with the skin and eyes, wash the affected area with water and seek medical advice.

In the case of battery liquid leakage, use protective gloves and clean the battery compartment with a dry cloth. Dispose of the materials used for cleaning.

PRECAUTIONS

Take the following precautions to avoid minor or moderate injury and damage to your device:

• Do Not Use this device if your skin is sensitive to mouthpiece and masks.

• Do Not Allow service or maintenance the equipment while used in patients.

• The patient is an intended operator and can perform the maintenance the equipment.

• If any operator requests more information such as circuit diagrams, parts list and product descriptions, for repairs carried out by qualified technical personnel, please contact the manufacturer.
  If there is any emergency, move the device off you first and then shut it off and contact the local dealer.

• Do Not Use if any of the following conditions apply to you:

• *You have an active skin condition in the treatment area including, sores,

• *psoriasis, eczema, sunburns, herpes simples, open wounds or a rash.

• *You have any other conditions which is in your doctor’s opinion would make it

• *unsafe for you to be treated.

• *Keep this device out of reach of children.

• *if you are not sure if the device is safe for you, please consult your doctor.

WARNINGS ON ELECTROMAGNETIC COMPATIBILITY

• The appliance is suitable for use in any environment indicated in these instructions for use, including domestic environments.
• Under certain circumstances, in the presence of strong electromagnetic disturbance, use of the appliance may be subject to limitations.
• Do not use this appliance in the immediate vicinity of other electrical appliances, as this could cause amalfunction.
• Failure to comply with these notes could be detrimental to the performance of theappliance.
• Mobile telephones or appliances that generate electromagnetic fields must not be used in the vicinity of the product.
• Do NOT use the product in environments subject to strong electromagnetic interference.
• Keep the device at least 3.5 metres from other electrical products with an energy consumption higher than 2 W, in order to avoid electromagnetic interference.

Additional quantitative data regarding electromagnetic compatibility are available from Naweti and can be obtained upon request.

PACKAGE CONTENTS

• Main unit Medicinal product reservoir
• Accessories (child mask, adult mask, mouthpiece)
• Waterproof bag
• USB cable
• These instructions for use

Appliance functions
This device complies with IEC 60601-1-11 standards and is designed for the treatment of respiratory disease and the prevention of respiratory tract infections. It canbe used inthe treatment of respiratory tract conditions, such as colds, fever, bronchitis, asthma,  pneumonia, pulmonary mycosis and cardiopulmonary disease. The exact therapy to be administered must be prescribed by a medical practitioner.
This appliance is based on a technology that uses the oscillation of the piezoelectric crystal inside it to transform medicinal products for inhalation into micro droplets of liquid. These micro droplets are able to penetrate deep into the upper and lower airways, to carry the active substances to the right places in a targeted manner.
The nebulisationspeed has been studied to guarantee maximum effectiveness from treatment and is calibrated to adapt to use by both adults and children.
Appliance characteristics

• Portable device providing high-efficiency nebulisation.
• Silent operation with noise levels of under 25 db during nebulisation. Finely nebulised particles.
• Provided with a liquid level sensor that stops the device when the medicinal product reservoir is empty.
• Choice of power supply: by battery (not provided) or USB cable (provided).

DESCRIPTION OF THE APPLIANCE

1. Medicine cup
2. Meshatomizer
3. on/off button
4. Apparatus body
5. Snap-Fit| 6. USB interface
7. Battery cover
8. USBcable
9. Child mask
10. Adult mask| 11. Mouthpiece
12. AA Batteries (not included)
13. power indicator light
14. run indicator light
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INDAICATOR LIGHT & OPERATION DESCRIPTION

• Run indicator light:
  Atomization mode: green light breathing.
  Cleaning mode: blue light breathing.
  Water shortage: turn off after the blue light flashes for 4 times.

• Power indicator light:
  Low battery: yellow light on.

• operation description (Atomization rate adjusted: No):
  In the shutdown state, press the on/off button key to start Atomization.

In the atomization state, press the on/off button t to shut down.
In the shutdown state, press and hold the on/off button to start cleaning mode.

APPLIANCE PREPARATION

This nebuliser can operate either on the USB cable (provided) or AA batteries (not supplied) connected to a power supply unit (not provided). The power supply unit must satisfy the following parameters:

• input voltage: 100-240 V AC, 50/60 Hz;
• output voltage: 3-5 V DC,1-2 A;

1. Use with the USB cable provided
   This appliance can be operated using the USB cable provided.
   • Remove the batteries;
   • connect the cable to thesocket;
   • connect the cable to the power supply unit (not provided).
   Note: Check that the output port of the power supply unit matches the AC power supply required.
   To guarantee safe use, use a power supply unit that meets electrical safety standard IEC 60601-1.

2. Before using the unit for the first time.
   Notes
   • The atomizer and accessories must be cleaned and disinfected before they are used for the first time. For information about this, see “CLEANING and MAINTENANCE”.
   • Parts (child mask, adult mask and mouthpiece) in contact with human body should only be used by the same person to prevent cross infection.

3. Assembly of the nubulizer
   • Remove the unit from the packaging.
   • Fit the medicine cup onto the apparatus body. (image1)
   • 3.When remove the medicine cup, please press the Snap-Fit down in the direction of the arrow in image 2, and push the medicine cup to avoid damage to the nebulizer. (image 2).

4. Inserting the batteries
   • To open the battery cover on the underside of the device.
   • Insert ALKALINE or Rechargeable batteries (type AA). Ensure that the poles of the batteries are touching their respective poles in the device.
   • Fold the battery cover down and push it back in place. Notes
   • When changing batteries, ensure that the medicine cup is completely empty, otherwise there is a risk of leaks.
   • Spraying becomes much less effective when the batteries are weak.
   • Do not mix different types of batteries.
   • If the unit will not be used for a long time, please take out the battery.

5. Operating the device with the A/C Adapter
   • Insert the USB cable into the USB interface.
   • Connect the USB cable to the power adapter.
   • Plug adapter the A/C outlet.

INSTRUCTION FOR USE

1. Preparing the nebulizer
   • For reasons of hygiene, it is imperative that the nebulizer and accompanying accessories are cleaned and disinfected after every use.
   • If the therapy requires that various different medicines be inhaled in succession, ensure that the medicine cup is rinsed after every use.

2. Filling the nebulizer
   • Open the medicine cup by opening the clip, and fill the medicine cup with normal saline or medicine. Do not overfill the container. The maximum recommended fill amount is 8ml. (image 5)
   • Use medication only on the advice of a physician, and check the appropriate inhalation duration and quantity for your needs.

3. Closing the reservoir
   • Close the lid of the medicine cup and lock the clip in place.
   • Do not shake the nebuliser or turn it upside-down, which could cause spillage of the medicinal product.

4. Fitting the accessories
   • Fit the appliance with the appropriate accessory: use the mouthpiece for treatments to be administered to the throat, and the child or adult masks for treatments to be administe-red through the nasal cavity or to the throat (image 6).
   • Hold the appliance up to the mouth and place the lips tightly around the mouthpiece.
   • When using the mask, place it over the nose and mouth, without covering the eyes.
   • Start the appliance by pressing the ON/ OFF button. If the device is working correctly, the green indicator light will come on and nebulised medicinal product will be released from the appliance.

5. Indications for correct inhalation
   • During the treatment, you should be calm, relaxed and seated, holding the nebuliser in one hand.
   • Takeslow, deep breaths to allowthe particles to distribute effectively.
   • When using the mouthpiece, take the flat end of the mouthpiece to the mouth and close the lips slightly to allow the medicinal product to reach the desired area.
   • When using the mask, hold it up to the face to cover the nose and mouth. For treatment via the nasal cavity, breathe in through the nose and out through the mouth. For treatment via the throat, breathe in through the mouth and out through the nose.
   • After assembly and before use, pour sterile saline solution or deionised water into the medicinal product vessel and press On/Off to check it is working correctly.
   • To use the mouthpiece correctly, the liquid should not be directed towards the tongue.
   • Do not swallow the liquid, make sure it reaches the intended area.
   • Breathe regularly and without sudden movements to avoid potential obstructions.
   If so, the red indicator light will flash continuously and will switch off automatically. The nebuliser will not operate if the medicinal product vessel is empty. Tilt the main unit slightly towards you to wet the vibrating mesh with the medicinal product.
   • Nebulisation will only occur if the vibration device is immersed in the medicinal product.
   • When the medicinal product level is low, tilt the device towards you from the On/Off side and collect the medicinal product that has accumulated on the plate to use all the residual product.
   • The device must be protected against blows, as they could break the plate.
   • When the yellow low power indicator light continues flashing slowly, the power supply is low. Insert new alkaline batteries or connect to the power supply unit as soon as possible, as an alternative to batteries.
   • Do not shake the device violently during use, otherwise it will switch off automatically.
   • The device may not be used with hard water, as it could damage the appliance.

6. After treatment
   • At the endof the treatment, switch the appliance offusing the ON/OFF switch. The green power indicator light will switchoff.
   • The appliance is provided with a liquid level sensor that stops the device when the medicinal product reservoir is empty. For technical reasons, a very small amount of product will be left in the reservoir and must be disposed of before putting the device  away. Make sure that there are no batteries in the device during use.
   • When using the portable battery charger/power supply unit, remove the plug from the mains socket after use.
   • The medicine cup and accessories (child mask, adult mask and mouthpiece) must be cleaned after use. For information, see “Cleaning and MAINTENANCE”.

7. Dismantling the appliance
   • Remove the mouthpiece ormask.
   • Holding the main unit in one hand, press the button on the rear.
   • Holding the medicinal product vessel in the other hand and remove the medicinal product reservoir from its recess by sliding it forwards.
   • Open the lid, dispose of the residual medicinal product, then clean the device and leave the various parts to dry. Store the device ina clean, well- aired and dry place.
   • For further details, see the “Cleaning and MAINTENANCE” section.

CLEANING and MAINTENANCE

** To guarantee correct device operation, it is important to ensure that the Cleaning operations described below are carried out carefully. Otherwise, the device might not dispense the medicinal product the next time it is used, orthe medicinal product might  be dispensed, but very slowly and not at the ideal speed. Remember to turn off the device after use.
Make sure the device is switched off after use.
After each use, discard the leftover medicinal product and remove the accessory from the main unit in order to clean it thoroughly .Dry the parts immediately after washing. Do not stow away the main unit, medicinal product vessel or other accessories when wet or damp.
Observe the following hygiene instructions in order to avoid any health risks. The nebulizer and accessories are intended for multiple use. Please note that cleaning and hygienic reconditioning requirements differ according to the different areas of application.
Parts (child mask, adult mask and mouthpiece) in contact with human body should only be used by the same person to prevent cross infection.
Cleaning and sanitising the medicinal product reservoir**

• Remove the mouthpiece and any accessories from the atomizer.
• Open the vessel and discard any leftover medicinal product.
• Pour a small amount of hot distilled water (30-60°C) into the vessel and close the lid.
• Press press and hold the on/off button for 5 seconds to start cleaning mode, the blue power indicator light will come on.
• Switch the device on in cleaning mode to nebulise the distilled water for 1-2 minutes in order to eliminate the residual medicinal product. The cleaning mode stops automatically after 3 minutes.
• Rinse the vessel and lid with distilled water. Carefully remove any excess water with a clean, soft cloth or leave the parts to dry naturally in a clean place.
• Use medical gauze or cotton buds for cleaning and disinfecting operations.
• **** Use medical gauze or cotton buds for cleaning and disinfecting operations.
• Do not rub with paper or other cloths, to avoid compromising the correct operation of the appliance.
• Do not clean using sharp objects or touch the mesh.
• Do not use household bleach or other aggressive substances to clean the device, only the solution indicated above is allowed.

Cleaning and sanitising the main unit

• Carefully clean the main unit using a 75% rubbing alcohol solution and remove any excess with a clean, softcloth.
• Clean the electrodes connecting the main unit and the medicinal product vessel using the procedure indicated above.
  Do not clean the main unit using volatile liquids such as petrol or diluents.
  Do not rinse the main unit or immerse it in any liquid.

Cleaning and sanitising the mouthpiece and masks

• Remove the medicine cup, mouthpiece or mask.
• Rinse the medinecup, mouthpiece and mask with de-mineralised water alone for 2-3 minutes (water temperature ≤50 °C).
• Dry well using medical gauze.
• Immerse the mask and mouthpiece in a 75% rubbing alcohol solution for at least 3 minutes to disinfect them and leave to dry naturally.
• Store the appliance in the carry case provided, when not in use.

Notes

• The cleaning mode is very important and must be completed, otherwise the atomizer will be blocked and cannot be used normally.
• Do not put pressure on the mesh with brushes or similar, as this may easily puncture the mesh causing irreparable damage, and will void the warranty. The metal is very thin and can be punctured easily.
• If any traces of medical solutions or impurities remain on the metal contacts on the device and atomizer, use cotton buds to remove them.
• Clean accessories & Medicine cup
• Remove the medicine cup and accessories (child mask, adult mask or mouthpiece) from the nebulizer. Clean with purified water.

TROUBLE-SHOOTING

In the event of problems during use of the appliance, consult the information below.

otherwise add medicinal product.
The power indicator flashes for 1 second and then turns off| The medicine bottle is not properly installed.| Make sure the medicine bottle is properly installed.
Insufficient medicine in the nebulizer or no medicine was loaded.|  Fill the medicine bottle with the proper amount o medicinal product.
The medicine bottle is not clean.| Clean the medicine bottle.
The medicinal product level is low.| Tilt the main unit slightly towards you, otherwise add medicinal product.
The power indicator does not light, and the device not nebulize| The batteries have not been inserted properly.| Insert the batteries correctly.
The medicine used is unsuitable for spraying (e.g. too thick, viscosity must be less than 3)| Add normal saline to dilute. Always follow the instructions of your physician.
Batteries are exhausted.| Replace the new batteries.
The run indicator light is
not on, and the atomizer
is not sprayed.| The positive and negative directions of the battery are reversed. (AA battery type)| Make sure the battery is installed correctly.
The battery runs out. Or the power adapter (to be purchased by the user) is not properly connected to the atomizer.| Replace the battery with a new one (AA battery type) or charging (Lithium battery type only). Reconnect the power adapter properly.
Restart the machine.
Once turned on, the device switches off after a flew seconds| The medicinal product level is low.| Tilt the main unit slightly towards you, otherwise add medicinal product.
The medicine bottle is not clean.| Clean the medicine bottle.
The device automatically shuts down in use| The medicine bottle is not properly installed.| Make sure the medicine bottle is properly installed.
Medicine is running out but the device cannot automatically power off| There is no medicinal product in the bottle.| Fill the medicine bottle with the proper amount o medicinal product.
The medicine bottle is not clean.| Clean the medicine bottle.
The Medicine of medicine bottle is leaking| Certain medicines may produce some foam in the medicine bottle.| Press the START/STOP button to turn the device off, and clean the foam.
The medicine bottle is not clean.| Clean the medicine bottle.
Medicine bottle is broken or damaged.| Replace the medicine bottle before using the device again.

DISPOSAL

The product packaging is made of recyclable materials. It must be disposed of in compliance with environmental regulations.
For environmental reasons, the appliance must not be discarded with normal household waste at the end of its service life.
It must be taken to an appropriate disposal facility. Dispose of the appliance in accordance with European Directive 2012/19/EU regarding waste electrical and electronic equipment (WEEE). For further information or clarification, contact the local authority responsible for waste disposal.

PRODUCT SPECIFICATIONS

Product name: Portable Mesh Nebulizer
Model: WH202
Battery type: AA battery
– Power supply mode: AA battery type: DC 3V (AA x 2) or DC 5V (A/C Adapter)
Product dimensions: 64x46x98 mm
Weight: approximately 80 g (excluding batteries)
Capacity: max. 8 ml
Median particle size of atomized particles: 3.0μm±25%
Atomized particles not less than 4μm： ≥80%
Atomization rate adjusted: No
Medication flow rate: ≥ 0.2 ml/min
Vibration frequency: 120 kHz ±10%
Working noise: ≤ 25 dB
Working conditions:

• Temperature: 0 °C ~ 40.0°C
• Relative humidity range: 15% ~ 93%
• Atmospheric pression: 86kPa ~106kPa

Conditions for storage and transportations:

• Temperature: -40°C -55°C
• Relative humidity range: 15% ~ 93%
• Atmospheric pression: 0 ~ 106.0 kPa

U.S. chips, designed in the U.S. and assembled in China

AFTER-SALES SERVICE AND WARRANTY

This appliance is intended for domestic use only andis notsuitablefor professional purposes.

• The warranty covers production defects only and is not valid for damage caused by accidents, incorrect use, negligence or improper use of the product.
• The appliance must not be opened under any circumstance; the warranty is not valid if the product has been opened or tampered with.
• If the product fails, please send an email to Naweti-Service@hotmail.com. We will provide corresponding solutions to the product problem
• The manufacturer declines all responsibility for any damage/injury that may be directly or indirectly caused to people, property or domestic animals as a consequence of failure to comply with the indications provided in this instruction manual, in particular the warnings regarding the installation, use and maintenance of the appliance.
• Given its on-going commitment to improving its products, Naweti reserves the right to modify all or parts of its products in order to meet production requirements, without giving advanced notice, without this entailing any responsibility for Naweti or its dealers.

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