Please read the user manual carefully in order to ensure safety use.
1. Precauions
Warning
Prompting the operations with danger or unsafe, if continue operating, it may cause death, server body injury or property lose.
Attention
Emphasizing important notices, instructions or explanations for better use.
Warnings
Please follow doctors’ advice about medication species, dosage and usage. Otherwiseit may cause symptomatic deterioration.
Please follow the specified operation methods in the user manual, otherwise it maycause operation failure.
The accessories of device are designed for single use, do not reuse the accessory, otherwise it may cause cross infection.
For the first time of using this device or medication cup is unused for a long time, medication cup and mask must be cleaned and disinfected. Otherwise, it may cause bacterial reproductive infection.
Each user must use the accessory separately, otherwise it may cause cross infection.
Please clean the accessories after disinfection, otherwise patient may inhale the residual disinfectant, which may cause symptomatic deterioration.
Used medication can’t be reused, please change new medication for every treatment. Otherwise patient may be infected by varieties of bacteria, causing symptomaticdeterioration.
Do not use the device to inhale water, otherwise it may cause symptomatic deterioration.
Do not use the device at ambient temperature above 40℃. Otherwise it may cause nasal mucosa injury or device failure.
Do not clean the main body by water or drop it into water or store the device in humid environment. Otherwise it may cause device failure.
Please do clean the device after use, and dry it immediately after clean. Otherwise patient may be infected by varieties of bacteria.
Please keep the device out of the reach of children and people with mental illness. Otherwise it may cause danger of swallowing small parts.
Do not use the device near flammable or explosive gas or anesthetic mixture. Otherwise it may cause personal injury.
Avoid twining children’ dangerous parts(for example neck) by the power cord, or it may cause asphyxia.
The mask of this equipment is made of PVC material.The material passed the relevant test. After assessment,there is no unacceptable risks.
This device should not be used where it is difficult to disconnect the power supply device.
If the storage temperature is lower or higher,please leave the equipment in normal working environment for more than 1 hour. Until it is ready for intended use.
It is not allowed to modify the equipment or it may cause equipment or it may cause damage to the equipment.
Attention
If the device can’t shutdown automatically when medication is exhausted, please immediately press the "ON/OFF" buttonto turn off, in order to avoid damage to the nebulizing sheet. Refer to Chapter 6 Troubleshooting.
Clean medication cup after each use. Otherwise, the device will not work normally.
When cleaning medication cup, do not directly place the device under tap water in case water ingresses the device.
Do not use this product near high-frequency electromagnetic transmitters and other high-frequency electronic products.
Keep the devicevertical as much as possible during use.
Avoid the main unit and medication cup falling or subject to severe impact.
Do not touch the metal mesh of nebulizing sheet with a cotton swab or other sharp objects. Otherwise, the device may not work.
This product is subject to the guidance of a doctor. Patient who has sensitive parts with contusion, burns, inflammation,and facial/oral trauma should avoid using. If any discomfort appears during use, please stop using immediately and consult a doctor.
Do not mix different types of dry batteries.
Ensure that a guardian is present when used by children.
Do not store or carry the device with medication in the medication cup.
Disposal of waste main parts and accessories shall follow the local government regulations.
The use of this product is different from the laryngeal and nasal mucosa humidification equipment.
This product can not be used in respiratory anesthesia systems and ventilator systems.
Please take batteries out if you won’t use the device for long time.
The device service life is 3 years(excluding consumables).
The accessories are disposable, the device is sterilized by ethylene oxide, please check the packaging carefully before use, stop using it and contact with suppliers if there is obvious damage.
If necessary, provide circuit diagrams, components lists and necessary information for maintenance, please contact with supplier.
2. General
2.1 Function and application
The nebulizer can atomize medication into a mist of microscopic droplets, which can be easily inhaled into respiratory system along with breathing, achieving therapeutic effect for respiratory diseases such as acute inflammation of the upper respiratory tract, acute and chronic tracheitis, bronchitis and swelling and pain in throat, etc.
Contraindications:
The patients with bronchial asthma or acute emphysema are not recommended to use the device, please follow the doctor's advice.
2.2 Features
Power supply: DC 5 V or 2 “AA” alkaline batteries
Input power: <3 VA
Nebulization rate: ≥0.25 mL/min
Noise: ≤50 dB
Equivalent volume particle diameter distribution: the occupation of small atomized particles (diameter＜5 µm) is no less than 90 %.
Type of protection against electric shock: Class Ⅱ
Degree of protection against electric shock: type BF applied part
Degree of protection against ingress of liquid: IP22
Note: please choose the power adapters manufactured by qualified companies(input: AC100-240V, 50Hz / 60Hz, output: DC5V, 1A).
The voltage of 2 “AA” alkaline batteries is DC3V.
2.3 Operational environment
Temperature: 5 ℃～40 ℃
Humidity: 15 %～90 %
Atmospheric pressure: 700 hPa～l060 hPa
Attention: This product is not suitable for use in strong electromagnetic interference environments (such as various medium/high frequency therapeutic instruments, transformers, large electrical cabinets, radio and television transmission towers, other radio frequency transmitting equipment, and other electrical appliances or medical equipment may generating interference.).
2.4 Principles
Principle of nebulization
The high-frequency vibration of piezoelectric ceramic plate directly leads to the deformation of microplate, making medication in contact with the microplate extruded from it to form a mist spray effect. The mesh nebulizer is applicable for use in hospital, clinic and family.
Principle of treatment
Respiratory system is an open system. The atomized medication, after inhalation, can be directly adsorbed on patient’s oral cavity, throat, trachea, bronchus and pulmonary alveoli, etc., through its mucous membrane absorption to achieve the purpose of treatment.
3. Product composition
Component description: The nebulizer consists of main unit , medication cup,mask and the power adapters(optional).
Nebulizer:
Accessories:
4. How to use
4.1 Assembly
1. Remove all packages
Attention: For the first time of use, please clean and disinfect the device before use.
Assembly of nebulizer
(1) Install medication cup to the main unit by pushing it towards to the main unit.
Attention: When installing medication cup to the main unit, be sure to install it properly until clasp sound is heard. Otherwise it may cause electrode conduction failure, then the device can not atomizing normally.
(2) Remove medication cup from main unit. Press and hold the "PUSH" button on main unit, and push medication cup away from the main unit.
Attention: In order to avoid device damage, please press the "PUSH" button first when removing medication cup.
(3) Assembly of battery
(1) Open the battery cover.
(2) Insert the 2 "AA" alkaline batteries according to the polarity label on battery cover. Attention: Do not reverse the battery. Insert the battery exactly following the label of “+” “-” on the battery cover.
(3) Close the battery cover.
Battery service life and replacement:
(1) When replacing the battery, make sure there is no medication or water in medication cup. If yes, please remove the medication cup first.
(2) When the orange indicator is light, the device can also work for a while, but it is recommended to replace the new batteries.
(3) Usually two new "AA" alkaline batteries can work continuously 1 hour under normal working situations.
Attention:
Please do not mix batteries of different manufacturers or models, otherwise the battery life will be affected.
Remove the batteries if the device won’t be used for long time.
4.2 Operations for treatment use
Preparations before use:
1. Remove medication cup, please clean and disinfect it before use.
2. Infusion of medication: Open the cup lid, decant medication into medication cup. As shown below:
Attention:
(1) Before using any pharmaceutical products or medicines, please consult your doctor to ensure that you are using the product correctly.
(2) Do not use the medication of high concentrations, high viscosity, oily medicines, suspended or volatile liquid medicine, doing so may lead to abnormal atomizing.
(3) It is recommended not to exceed the capacity of medication cup. If medication cup is fulled with medication, be sure to cover the cup lid to prevent leakage.Medication in the cup should not be less than 2mL(The maximum capacity for the medication cup is 10mL).
3. Close the cup lid.
4. Install medication cup to main unit.
5. Assemble the mask, as shown below:
Operation method:
1. Turn on the power: Press “ON/OFF” button for more than 1 second, power indicator (green) lights and device starts atomizing.
Attention:
If medication cup is not loaded with any medication, the device will automatically shutdown after power indicator lighting about 1s.
After startup, the quantity of medication mist may change at the beginning of device working, which is a normal phenomenon.
2. Inhalation: Hold the device in hand, put on the mask, slowly inhale the medication mist.
Attention:
(1) The angle of inclination should be within 45° during nebulizing.
(2) During use, please do not strongly shake the device to prevent abnormal use.
(3) Duration of each inhalation should be no more than 20 minutes.
(4) Nebulizing treatment is easy and comfortable, if you have any discomfort during use, please stop the treatment.
3. Turn off the power: When the treatment is over, and medication almost runs out, the nebulizing sheet will generate a high-frequency sound, and then the device automatically turns off. If you need to shut the device down during use, please press the “ON/OFF” button for more than 1 second.
Attention:
At the end of treatment, it is normal that a little medication left in medication cup after automatically shutdown.
5. Maintance, Transport and Storage
5.1 Clean and disinfection
Clean and disinfect the device after each use. If the device doesn’t clean up, the nebulizing will be affected because of drying and coagulation of medication.
1. Remove medication cup, accessory and batteries from the main unit.
2. Open the cup lid and discard residual medication.
3. Add 75% ethanol solution in medication cup, cover the cup lid, then leave for at least 10mins; it is available to gently shake it for better disinfection.
4. Immerse the accessories to be disinfected into a container with ethanol solution, and lid the container. Use 75% ethanol solution soaking for 10mins or longer.
5. Discard the disinfectant in medication cup, take accessories out from the disinfectant; clean the medication cup and accessories with clear-water repeatedly.
6. Fill medication cup with clear-water, assemble it to the main unit, let the device work 10mins in order to clean the nebulizing sheet.
7. After cleaning, use new medical gauze to wipe away the water, and fully dry.
8. Use 75% medicinal alcohol to wipe the surface of main unit, then air-dry or wipe-dry with a clean, soft cloth.
9. After all steps above, store the main unit, medication cup and accessories in a dry, clean place.
Attention:
Do not throw medication cup and accessories into boiling water for disinfection, otherwise the part may be out of shape. Do not put them in a microwave oven for drying.
The parts disinfected with disinfectant must be fully cleaned, or the residual disinfectant may cause symptomatic deterioration.
5.2 Medication cup replacement
The nebulizing sheet is a kind of consumable, In general, the service life of the atomizer is about six months(20 minutes per time, three times a day).
its service life depends on the use, medication, and the degree of cleaning. If no atomizing or little atomizing appears when device working, please replace medication cup in time. (If you need to purchase medication cup, please contact the dealer.)
5.3 Transport and storage
Environment of transport and storage:
Temperature: -40 ℃～+55 ℃
Relative humidity: 5 %～96 %
Atmospheric pressure: 500 hPa ~ 1060 hPa
Requirement of transport and storage:
No corrosion gas and well-ventilated room.
Keep the device out of the reach of children.
Do not store the device in places such as direct sunlight, high temperature, humid, dustyor easy to get to water, etc.
Avoid the device from slope, vibration or shocked.
Transportation adopts general transportation means or follows the contract requirements. Avoid violent shock, vibration, rain and snow splash during the process of transportation.
5.4 Pollution-free disposal and recycle
The service life of product is 3 years. If the device exceeds the period of use, it must be discarded. Please contact the manufacturer or distributor for more information.
1) The atomizer out of use can be sent back to the manufacturer or distributor for proper recycling.
2) Used parts can be returned to the manufacturer or distributor for disposal, or in accordance with relevant laws and regulations.
6. Troubleshooting
Problems | Reason analysis | Solutions |
The device can’t startup. | Battery is not well installed. | Check the installation of battery, and reinstall the batteries. |
No atomizing or little atomizing appears when device working. | Medication cup is not well installed. | Check the installation of medication cup, and reinstall it. |
No medication in medication cup | Trickle medication into medication cup, remember do not exceed its maximum capacity. | |
Improper medication | Consult a doctor if the medication is suitable for the device. | |
The nebulizing sheet is dirty | Clean medication cup. | |
There is water around the nozzle of nebulizer. | Due to temperature differences, the temperature of medication cup surface is relative low, medication mist in contact with the nozzle, then condenses into water droplets. | Remove medication cup, pour the water out. |
After startup, power indicator lights about 1s, then immediately goes out. | Medication cup is not well installed. | Install medication cup once again. |
Medication cup is not loaded with any medication | Put the medication into medication cup after consulting your doctor. | |
After turning on the device, the power indicator lights once, then it is out immediately or the device can not work normally. | The battery had run down. | Replace the batteries immediately. |
Nebulizer doesn’t automatically shutdown when medication is used up. | Medication may generate bubbles in medication cup | Press “ON/OFF” button to turn off the device, and clear up the bubbles. |
Medication may attached on the nebulizing sheet | Press “ON/OFF” button to turn off the device, and clean medication cup. | |
The electrodes contacting with the medication cup may be dirty | Press “ON/OFF” button to turn off the device, and clean the electrodes. | |
If the device still can’t work normally after doing all methods above, pleas contact our after-sales service. | ||
7. Meaning of symbol
| Symbol | Meaning |
 | Type BF applied part |
 | Class Ⅱ equipment |
| IP22 | The degree of waterproof and dustproof is IP22. |
 | Keep dry |
 | Fragile, handle with care |
 | This way up |
 | Humidity range for transportation: 5 %～96 % |
 | Temperature range for transportation: -40 ℃～+55 ℃ |
 | Atmospheric pressure for transportation: 500 hPa ~ 1060 hPa |
 | This item is compliant with Medical Device Directive 93/42/EEC of June 14, 1993, a directive of the European Economic Community. |
 | Refer to instruction manual/booklet |
 | Manufacturer |
 | Serial Number |
 | WEEE (2002/96/EC) |
 | Date of manufacture |
 | Stand-by |
8. packing List
1. Main unit 1pc
2. User manual 1pc
3. Medication cup 1pc
4. Accessories 1set (adult mask, child mask)
Appendix I
Curve chart of equivalent volume particle diameter distribution:
the median particle diameter (D 0.50) is1~4 µm.error shall be within ±25 %
Appendix II
Warning
The device should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, it should be observed to verify normal operation in the configuration in which it will be used.
Use of ACCESSORIES and cables other than those specified, with the exception of transducers and cables sold by the MANUFACTURER of the ME EQUIPMENT as replacement parts for internal components, could result in increased EMISSIONS or decreased IMMUNITY of the ME EQUIPMENT or ME SYSTEM.
Operation of the device below the minimum value described in this manual may cause inaccurate results.
Guidance and manufacturer’s declaration – electromagnetic emissions-
for all EQUIPMENT and SYSTEMS
Guidance and manufacturer’s declaration – electromagnetic emission | ||
The NE-M01 is intended for use in the electromagnetic environment specified below. The customer of the user of the NE-M01 should assure that it is used in such and environment. | ||
Emission test | Compliance | Electromagnetic environment – guidance |
RF emissions CISPR 11 | Group 1 | The NE-M01 uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. |
RF emission CISPR 11 | Class B | The NE-M01 is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. |
Guidance and manufacturer’s declaration – electromagnetic immunity –
for all EQUIPMENT and SYSTEMS
Guidance and manufacturer’s declaration – electromagnetic immunity | |||
The NE-M01 is intended for use in the electromagnetic environment specified below. The customer or the user of NE-M01 should assure that it is used in such an environment. | |||
Immunity test | IEC 60601 test level | Compliance level | Electromagnetic environment - guidance |
Electrostatic discharge (ESD) IEC 61000-4-2 | Air Discharge:±2kV, ±4kV, ±8kV, ±15kV contact:8 kV air | Air Discharge:±2kV, ±4kV, ±8kV, ±15kV contact: 8 kV air | Floors should be wood, concrete or ceramic tile. If floor are covered with synthetic material, the relative humidity should be at least 30%. |
Powerfrequency (50/60Hz) magnetic field IEC61000-4-8 | 30A/m | 30A/m | Mains power quality should be that of a typical commercial or hospital environment. |
NOTE: UT is the a.c. mains voltage prior to application of the test level. | |||
Guidance and manufacturer’s declaration – electromagnetic immunity –
for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING
Guidance and manufacturer’s declaration – electromagnetic immunity | |||
The NE-M01 is intended for use in the electromagnetic environment specified below. The customer or the user of NE-M01 should assure that it is used in such an environment. | |||
Immunity test | IEC 60601 test level | Compliance level | Electromagnetic environment - guidance |
Radiated RF IEC 61000-4-3 | 10 V/m 80 MHz to 2.7 GHz | 10V/m | Portable and mobile RF communications equipment should be used no closer to any part of the NE-M01, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance 80 MHz to 800 MHz 800 MHz to 2.7 GHz Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m).Interference may occur in the vicinity of equipment marked with the following symbol: |
NOTE 1At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. | |||
a:Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the NE-M01 is used exceeds the applicable RF compliance level above, the NE-M01 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the NE-M01. | |||
Recommended separation distances between portable and
mobile RF communications equipment and the Medical NE-M01
Recommended separation distances betweenportable and mobile RF communications equipment and the Medical NE-M01 | |||
The “NE-M01” is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Medical NE-M01 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the “NE-M01” as recommended below, according to the maximum output power of the communications equipment. | |||
Rated maximum output power of transmitter (W) | Separation distance according to frequency of transmitter （m） | ||
150 kHz to80MHz | 80 MHz to 800 MHz | 800 MHz to 2,5 GHz | |
0,01 | 0.12 | 0.12 | 0.23 |
0,1 | 0.38 | 0.38 | 0.73 |
1 | 1.2 | 1.2 | 2.3 |
10 | 3.8 | 3.8 | 7.3 |
100 | 12 | 12 | 23 |
For transmitters rated at a maximum output power not listed above, the recommended separation distanced inmeters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is themaximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. | |||