Qingdao Future Medical Technology NEB001 Intelligent Mesh Nebulizer User Manual
Qingdao Future Medical Technology Co., Ltd. Intelligent Mesh Nebulizer
User Manual
1
Instruction Manual
Intelligent Mesh Nebulizer
(Model No. NEB001)
2
Intelligent Mesh Nebulizer User manual
Version A/1
Copyright© 2017 Qingdao Future Medical Technology Co., Ltd. All rights reserved.
Print date: 26
February
2017
Qingdao Future Medical Technology Co., Ltd. reserves the right to make changes to its products or
specifications to improve performance, reliability, or manufacturability. Information furnished by
Qingdao Future Medical Technology Co., Ltd. is believed to be accurate and reliable at the time of
publication. However, Qingdao Future Medical Technology Co., Ltd. assumes no responsibility for its use.
No license is granted by its implication or otherwise under any patent or patent rights of Qingdao Future
Medical Technology Co., Ltd.. No part of this document may be reproduced or transmitted in any form or
by any means, electronic or mechanical, for any purpose, without the express written permission of
Qingdao Future Medical Technology Co., Ltd.. Data is subject to change without notification.
Qingdao Future Medical Technology Co., Ltd. has patents and pending patent applications, trademarks,
copyrights, or other intellectual property rights covering subject matter in this document. The furnishing
of this document does not give you any license to these patents, trademarks, copyrights, or other
intellectual property rights except as expressly provided in any written agreement from Qingdao Future
Medical Technology Co., Ltd. Specifications are subject to change without notice.
Manufactured BY:
Qingdao Future Medical Technology Co., Ltd, Room 401 Building F , No.169 Zhuzhou Rd, Laoshan District,
Qingdao City, Shandong Province, P. R. China.
TEL：+86-532-55677725
Indications for Use:
The Intelligent Mesh Nebulizer is designed for respiratory diseases treatment and respiratory-tract infection
prevention.
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Table of Contents
Chapter 1 Before you start .................................................................................................................... 5
1. What is Intelligent Mesh Nebulizer? ..................................................................................... 5
2. Intelligent Mesh Nebulizer description ................................................................................. 6
3. Getting to Know your Device ................................................................................................ 7
4. Intelligent Mesh Nebulizer Indication for Use ...................................................................... 7
5. Deciding to Use Device ......................................................................................................... 7
Chapter 2 Important Safety Information .............................................................................................. 8
Chapter3 Safety Features of the Nebulizer ....................................................................................... 11
1. With Intelligent Mesh Nebulizer Safety Comes First ......................................................... 11
2. Additional considerations of using Intelligent Mesh Nebulizer. ........................................ 11
3. Protect your Intelligent Mesh Nebulizer ............................................................................. 11
Chapter 4 Benefits and Risks of Using the Nebulizer............................................................................ 12
Chapter 5 How To Use the Nebulizer.................................................................................................. 12
1. power supply ........................................................................................................................ 12
2. Assembly Nebulizer .............................................................................................................. 13
3. Add medicine liquid ............................................................................................................. 14
4. Usage of Nebulizer ............................................................................................................... 15
5. Turn Off The Power ............................................................................................................. 19
6. After Using ............................................................................................................................ 19
Chapter 6 Maintenance of the Nebulizer ............................................................................................ 20
1. Cleaning ................................................................................................................................ 20
2. Disinfecting ........................................................................................................................... 21
3. Cleaning and Disinfecting of Mouthpiece and Masks ........................................................ 22
4. Storage and transport .......................................................................................................... 22
5. Maintenance ......................................................................................................................... 22
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6. To protect the environment .................................................................................................. 23
Chapter 7 Troubleshooting ................................................................................................................. 23
Chapter 8 Customer Service ............................................................................................................... 25
1. Quality Assurance ................................................................................................................ 25
Chapter 9 Product Specifications ....................................................................................................... 26
Chapter 10 Electromagnetic Compatibility ......................................................................................... 28
1、Electromagnetic Compatibility .......................................................................................... 28
2、 Notes on FCC certification .............................................................................................. 30
Chapter 11 Labeling
，
Marks and Symbols ........................................................................................ 30
1、Labeling .............................................................................................................................. 30
2、 Marks and Symbols.......................................................................................................... 31
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Chapter 1 Before you start
Thank you for purchasing NEB001 Intelligent Mesh Nebulizer (Hereinafter referred to the nebulizer
or the device). Before using Intelligent Mesh Nebulizer for the first time, you need to read this
Instruction Manual completely and pay particular attention to sections on device use procedures, device
operation, and after-use procedures.
SAVE THESE INSTRUCTIONS: We recommend you re-familiarize yourself with this Instruction
Manual before each use of Intelligent Mesh Nebulizer.
Intelligent Mesh Nebulizer is an electrical device. As such, it should be used with special attention
to safety.
READ ALL CONTRAINDICATIONS, WARNINGS AND SAFETY PRECAUTIONS BEFORE
USE, AND STRICTLY FOLLOW THEM WHEN USING Intelligent Mesh Nebulizer!
1. What is Intelligent Mesh Nebulizer?
The nebulizer consists of two parts: physical device and APP software.
For physical device，It is designed for respiratory diseases treatment and respiratory tract infection
prevention. It is intended to aerosolize physician-prescribed solutions for inhalation that are approved for
use with a general-purpose nebulizer.
For APP software, it consists of interactive games and information display which could enhance
entertainment and users' adherence to the nebulizer during treatment. It could be connected to the phyical
device by bluetooth.
If you don't want to use the APP, the physical device could also atomize normally. The atomizing
function of device is dependent from the APP software.
Package contents
Upon opening Intelligent Mesh Nebulizer package, you will find the following parts:
Intelligent Mesh Nebulizer Main Unit ,Atomizing Cup ,Adapter and Accessories (Mouthpiece and
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Masks).
Instruction Manual
Storage Bag
2. Intelligent Mesh Nebulizer description
Intelligent Mesh Nebulizer consists of the Main Unit, Atomizing Cup and Accessories .The Atomizing
Cup is used to be filled with medicine liquid for atomizing. The Main Unit is used to provide electricity
and the Accessories consists of Mouthpiece and Masks which are used to deliver the atomized medicine
to your respiratory system.
Picture 1 Physical components and APP software
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3. Getting to Know your Device
Table 1 Components and functions
Main Unit Provide electricity.
Atomizing Cup filled with medicine liquid
Mesh plate Create low velocity aerosol
PUSH button Disassemble the atomizing cup.
(ACTIVE/STAND-BY) button Active/stand-by the nebulizer.
Indicator light Green light on when the nebulizer works regularly;
Flash blue light when the battery is running out electricity;
Flash green light for 3s when there’s no medicine liquid in the
atomizing cup.
Charge indicator light Orange light on when charging regularly;
Green light on while finishing charging;
USB interface Connect the adaptor.
APP software Interactive games and information display.
4. Intelligent Mesh Nebulizer Indication for Use
The nebulizer is designed for respiratory diseases treatment and respiratory-tract infection
prevention. It is widely used in curing diseases of respiratory system, such as cold, fever, bronchitis,
asthma, pneumonia, pneumonic mycosis and pulmonary heart disease. It can also be used to cure
occupational disease; give throat care to the artists, cure nose, throat diseases like chronic allergic rhinitis,
acute laryngitis, etc.
The nebulizer shall be used with masks and mouthpieces. And the masks’ and mouthpieces’
connection tube diameter shall be 20.0±0.1mm. And the masks can be connected to the nebulizer tightly.
5. Deciding to Use Device
The nebulizer is available to pediatric and adult patients，is intended to aerosolize
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physician-prescribed solutions for inhalation that are approved for use with a general-purpose nebulizer.
The nebulizer can be used at clinics，hospitals and household environment, and it complies with
requirement of IEC 60601-1-11 which is a international standard for household medical device .
So:
1) Do you/your children have any respiratory problems and be appropriated to use the Device?
2) Have you consulted your doctor?
3) Is device safe for you or your children to use?
Next, carefully review the Important Safety Information, Contraindications, Warnings, Precautions
and Benefits sections found below, in order to decide if the device is safe for you or children to use.
If you have determined that this device is safe for you or your children to use and answered “yes” to
questions above, then this device may be right for you!
If you decide the Risks outweigh the Benefits, or that you cannot comply with any of the
Contraindications, Warnings, or Precautions, you should return your device within the first 30 days of
purchase.
Chapter 2 Important Safety Information
Important Safety Information - Read Before Use!
CONTRAINDICATIONS (Who should never use)
CONTRAINDICATIONS:
1) The device can not be applied to anesthesia breathing system and respiratory system.
2) children must under adults supervision.
3) Pentamidine is not applicable to the device.
You are unsure if the device is safe for you to use or not. Consult your doctor firstly.
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Discontinue to use if you encounter any discomfort. You may be allergic to accessories or another
condition. Consult your doctor please.
WARNING – No modification of this equipment is allowed
warning: for type or dose of medicine please follow the instructions of your physician and/or licenced
healthcare practitioner.
warning: to prevent cross infection, the device is used only by single patient.
warning: do not dry the device and its accessories with the microwave oven, oven drying, hair dryer, etc.
warning: do not make the nebulizer and its accessories contact corrosive liquids or gases.
warning: do not disassemble, repair or change the device.
warning: Direct plug-in plug is considered as disconnect device, please do not place the equipment in a
difficultly operation position.
warning: Please be careful about strangulation due to cables and hoses, particularly due to excessive
length. Keep this device out of the reach of children.
WARNING- TO REDUCE THE RISK OF ELECTRIC SHOCK THAT MAY CAUSE
SERIOUS INJURY OR DEATH:
● DO NOT use or store the device in humid locations, such as a bathroom. use the device within the
operating temperature and humidity.
● DO NOT operate the device or contact the Adapter socket or power switch with wet hands.
● DO NOT immerse the Main Unit in water or other liquid.
Never open Intelligent Mesh Nebulizer!
● Do NOT Use the Medicine with ester, fat or suspended particles, including herbal medicine, suggest
use the standard nebulizing Medicine in accordance with the physician's advice.
● Do NOT Install the Main Unit around the power lines.
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● Do NOT Operate the device near the heating device or open fire.
● Do Not Use the device before cleaning and disinfecting.
● Do Not Use mouthpiece and masks if its package is broken.
● Do Not Use the device if your hands are wet.
Use the device only for its intended use and as described in its manual.
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. The mouthpiece and
masks meet requiements of FDA .
Do Not Allow service or maintenance the equipment while used in patient.
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 manufacturer.
If there is any emergency happened, move the device off you first and then shut it off and contact
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 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 .
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Chapter3 Safety Features of the Nebulizer
1. With Intelligent Mesh Nebulizer Safety Comes First
The Intelligent Mesh Nebulizer has several built-in safety features
● Superior safety with lower voltage level
To protect user, the rated voltage of the device is 5 v.The lithium battery is designed to be with
protection mechanism which could avoid excessive charging or discharging, overheating and
over-voltage. And the battery also meets the requirement of IEC 62133:2012 which is an international
standard for battery.
● Intelligent Mesh Nebulizer has an automatic shut-off feature
while no medicine liquid is in Atomizing Cup at the beginning and ending of atomizing, the indicator
light (Green Light) will shine for 3 seconds and then turn nebulizer off by itself. These could avoid
overheating.
● One-time- use Accessories
These accessories(mouthpiece and masks) are one-time-use which could avoid cross infection.
● With APP presenting the atomizing time and dosage .
The APP can display the atomizing time and dosage in the process of atomizing so you can have much
more info. on your treatment to prevent inhalation in excess.
2. Additional considerations of using Intelligent Mesh Nebulizer.
This device is approved for human use only.
3. Protect your Intelligent Mesh Nebulizer
● Please keep Main Unit and Atomizing Cup clean (see chapter 6), or may cause nebulizer can't work.
● Keep medicine liquid and mesh completely contacting.
● Do not rinse or immerse the Main Unit in any liquid.
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Chapter 4 Benefits and Risks of Using the Nebulizer
The nebulizer provides the same basic function as an asthma inhaler, though many find it is easier to
use and more relaxing. The nebulizer is easier to use for children, the elderly, the sick and those in the
midst of an asthma attack as they do not require hand-breath coordination.
The nebulizer is considered much faster acting that taking oral medication, because it gets the
medication into your lungs quickly. The nebulizer is incredibly efficient in getting the medication to you.
There is no evidence suggesting that nebulizers cause more side effects than other inhalation
devices, such as metered dose inhalers (MDI) or dry powder inhalers (DPI). There are a few things to
look out for when using a nebulizer, however. With a face mask, a good fit helps prevent leakage of the
mist. A mouthpiece is sometimes preferred to stop skin or eye irritation from the circulating mist. Regular
cleaning of the nebulizer parts is necessary, because medicine can accumulate in the cup and the growth
of bacteria may cause infection.
Chapter 5 How To Use the Nebulizer
The device is a personal medical equipment. In order to prevent cross infection, the nebulizer is for
personal use only.
before first and after use, Please clean and disinfect the nebulizer. Keep the nebulizer dry after finish
using it. See Chapter 6 for more details.
1. power supply
●This nebulizer is powered with lithium batteries. The battery can be charged with Adapter.
●Adapter using
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picture 2 charging
1)Connect the nebulizer to Adapter；
2)Connect Adapter to power.
PRECAUTION:
1）To ensure safe using, the Adapter meet the electrical safety standard IEC 60601-1；
2）Adapter technical parameter as below ：
Model: HPU15-102
Input: 100-240Va.c. 47-63Hz 0.4-0.2A
Output: 5Vd.c. 2.4A Max.
3）DO NOT USE THE NEBULIZER WHILE CHARGING. THE NEBULIZER CAN NOT OPERATE
WHILE CHARGING. WE DO NOT TAKE RESPONSBILITIES OF USING CHARGER OR
ADAPTER INAPPROPRIATELY.
2. Assembly Nebulizer
1) Please clean and disinfect nebulizer before first using and after each using, then dry it, see chapter 6
for details)
2) Use One hand to hold the Main Unit, the another hand to hold the Atomizing Cup. Push the cup along
the slot ,until you hear a “Click” sound. (Picture 2 )
NOTE!
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1) If the Atomizing Cup isn't assembled in the right place, the device may not be able to operate
normally.
3. Add medicine liquid
1) One hand to hold the Main Unit, another to open Atomizing Cup buckle；
2) Add medical liquid into the Atomizing Cup and Please note: Max medicine liquid is 8 ml；
3) Tighten the Atomizing Cup cover.
Open the cover, add medicine liquid then close the cover, tighten the bottle
Picture 3 Add Liquid Medicine
NOTE!
1)After putting medicine liquid in, prevent nebulizer shaking or inverted which may cause the leakage of
medicine liquid.
2)When the Charger is used, remove the power plug from the electrical outlet before using the device.
Picture2 Nebulizer Assembly
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4. Usage of Nebulizer
Nebulizer Accessories are categorized as mouthpiece, adult mask and child mask. Please choose
appropriate accessories as your needs.
1) Connect mouthpiece or connect mask as Picture 4；
Picture 4 Mask Assembly and Mouthpiece Assembly
2) Enable Bluetooth on your cell phone, and launch the APP.
NOTE! You can download the APP from our official website.
3) Push ACTIVE/STANDBY button, the indicator light (Green Light) will light up and the device starts
to work. Put the mouthpiece flat end into the mouth, lips slightly closed or take mask slightly close to
face, better to cover nose cavity and mouth together.
Picture 5 start to atomize
4) Select the avatar of the game characters by sex and automatically enter the game interface(picture 6).
then select the available Nebulizer device in popup window (as shown in picture 7). After the selection,
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then APP will enter into the interactive game as picture 8.When you inhale, the shell launcher will
accumulate energy and when you exhale, the bomb will be fired up(picture 9 and 10). And the atomizing
time will always be displayed during playing games. After atomizing time is expired, you can check the
game scores as picture 11, if you want to start the game again, click or to refresh or
continue to picture 8 to start the game again. Press the" back" button on your cell phone or turn off the
“power” button on the nebulizer device ,the game will be terminated and go to picture 12 which could
display your scores and dosage, press the “back” button on your cell phone twice, you will exit the APP
or press the “home” button back to re-start your atomizing game.
picture 6
picture 7
sex
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picture 8
picture 9
picture 10
move from left
to right
shell launcher
energy accumulate
while inhaling
Atomizing time
fire up while exhaling
animals you
have captured
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picture 11
picture 12
5) Keep calm, relax and sit well holding the nebulizer smoothly, take deep and slow breaths and have
more effective ,amusing treatment.
NOTE!
1) Please use correctly mouthpiece, and don't spray the liquid to your tongue. Do not swallow the liquid
and make sure liquid does not go directly to the affected area.
2) Improper gesture and unsmooth breathing may cause respiratory passage blockage.
3) Slightly tilt the Main Unit toward yourself to immerse the Vibrating Mesh in the Medicine.
4) When Low Voltage Indicator (Blue Light) continue to flashing slowly, it means the power running out,
dosage
refresh or continue to
picture 8
Total scores
scores
Back to picture 6
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please recharge as soon as possible.
5) The dosage of medicine can be used as the physician suggested.
6）If you would like to try the APP, we recommend that you could use the mouthpiece to enjoy games. If
you are not interested in the APP, please ignore 2) and 4) in "4. Usage of Nebulizer". The atomizing
function of device is independent of the APP software.
5. Turn Off The Power
1)Press the ACTIVE/STAND-BY button to turn off the power, the Power Indicator (Green Light) will go
out.
6. After Using
1) Remove the mouthpiece or mask
2) Hold the Main Unit by one hand, and Press the PUSH button behind the Main Unit shown in Picture 7 ;
Hold the Atomizing Cup by the other hand, remove the Atomizing Cup along the slot ;
Picture 12 disassembly the Atomizing Cup
3) Open the lid, pour all the residual liquid Atomizing Cup, and promptly clean and disinfect the device,
allow the parts to air dry and store the device in a clean environment. See Chapters 6 for more
information.
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Picture 13 after using
Chapter 6 Maintenance of the Nebulizer
● After each use, first discard all residual medicine, and remove the attachment from the Main Unit to
clean and disinfect. Dry the parts immediately after washing.
● Be sure to turn off the device.
● Do not store when Main Unit, Atomizing Cup have any remaining liquid or moisture.
1. Cleaning
1. Atomizing Cup
1.1 Open the Atomizing Cup, and discard any residual medicine;
1.2 Pour a small amount of hot pure water ( Suggest temperature is 30-60 ) into the Atomizing Cup and ℃
close the Cap;
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1.3 Press the ACTIVE/STANDBY button , Turn on the device to nebulizer the pure water for 3-5 minutes
to remove residual Medicine from the mesh holes.
1.4 Rinse the Atomizing Cup with pure water. Gently wipe off excess water with gauze and allow the
parts to air dry in a clean environment.
Picture 14 cleaning
2. Main Unit
2.1 Gently wipe the Main Unit with 75% medical alcohol and wipe off excess liquid with a soft clean
cloth;
2.2 Clean the electrodes connecting the Main Unit and Atomizing Cup with 75% medical alcohol, in
order to make the device work normally.
CAUTION!
1) Do not wipe the Main Unit with other volatile liquid, such as Benzene or Thinner.
2) Do not rinse or immerse the Main Unit in any liquid.
2. Disinfecting
1. Atomizing Cup
1.1 After cleaning, disinfect the device using 75% medical alcohol as the way of cleaning. then pour
excess alcohol and cleaning the cup again as described above. Dry it with medical gauze.
NOTE!
1) Use medical gauze and medical cotton swabs to clean and disinfect.
2) Do not wipe with tissue paper or other cloth, otherwise the mesh will not nebulizer normally.
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3) Do not wipe or touch the mesh with your hand or any other sharp object.
4) Do not use other household bleach to clean the device in addition to the above solution.
3. Cleaning and Disinfecting of Accessories
Masks and mouthpiece are single use without cleaning and disinfection. Discard the mouthpiece and
masks after using in order to ensure the safety of your usage.
Wipe the Adapter with gauze or swabs before using. It do not need disinfection.
4. Storage and transport
1. Storage and transport Conditions:
(1) Temperature: -25 ~ 70 ;℃ ℃
(2) Relative Humidity: ≤90% R.H.
(3) Air Pressure: 70.0 ~ 106.0 kPa;
(4) Other requirements: No direct sunlight, Ventilation, No corrosive gas, No heating device, or Open
fire.
2. Storage Instructions:
(1) Keep the device out of the reach of unsupervised children.
(2) Clean and disinfect the device after using .Assemble and store the device in the Storage bag or in a
clean environment.
(3) If the device has been storage at low or high temperature, The device need more than half an hour to
warm from the minimum or maximum storage temperature between uses until it is ready for intended
use.
Validity: The device is advised used in 3 years and in 3000 hours; For the battery, the device can be used
for approximately 8 days after charging if operating for 30 minutes a day and the battery cycle life is 300
cycles. masks and mouthpiece are single use, do not use repeatedly.
5. Maintenance
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1.Working Conditions
(1) Environment Temperature: 5 ~ 40 ;℃ ℃
(2) Relative Humidity: 15% ~ 90% R.H No condensation;
(3) Air Pressure: 70.0 ~ 106.0 kPa;
(4) Power: DC 3.7V lithium battery
2. Maintenance Instructions
(1) Operate the device in normal work condition;
(2) Don't make the nebulizer and its Accessories contact corrosive liquids or gases.
(3) Refer to Chapter 7 for solution or contact the company or purchase dealer when the device can not
work.
(4) Please clean and disinfect the nebulizer as above in this Chapter.
(5) Please charge the device if you haven’t used for more than six months.
6. To protect the environment
The battery is not replaceable by yourself. Do not discard the device including its accessories(mouthpiece
and masks) optionally, you must contact local authorities to determine the proper method of disposal
because they may have potentially bio hazard.
Chapter 7 Troubleshooting
There are something problem in using the device, please find solutions in the following table 2.
Table 2 Troubleshooting
PROBLEM CAUTION SLOUTION
Cannot turn on 1.The battery is very low
2. The equipment is damaged
1. Pls recharge in time
2.Pls contact the authorized service
center or manufacturer.
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No mist
1.The handheld way is not right
2. The drug is misfit
3. The drug produces too much bubble
4. The equipment is damaged
1. Correct the handheld
2. The drug is too little or is unfit,for
this equipment ,pls consult a doctor to
use the drugs
3. Slightly shake the nebulizer until it
appears the mist
4. Pls contact the authorized service
center or manufacturer.
The device is on but
nebulizer weakly
1.Lithium battery is not electricity
2. the mesh cap of Atomizing Cup is not
clean
3. The drug is misfit
4. The sprayer module’s diaphragm is
damaged
5. the electrodes of the Medicine is not
clean
1. Pls recharge in time
2. Clean the Atomizing Cup, if still not
work properly, change a new one
3. The drug is too little or is unfit for
this equipment ,pls consult a doctor to
use the drugs
4. Pls contact the authorized service
center or manufacturer.
5. Clean the electrodes and start
Indicate light is blue
1.The lithium battery is not enough
electricity
Pls recharge in time
What drugs suitable
for atomization Consult your doctor Under the guidance of doctors advice
and use of drugs
Why will have some
liquid medicine
residues in the
equipment after each
use
Because when equipment automatically
shut down, you will immediately cease
inhaled liquids
Normal phenomenon
Mouthpiece ponding
Because of temperature difference, it
causes a little mist spray contact with the
mouthpiece when spray, but due to the
lower surface temperature, condensed
into water droplets.
Remove the mouthpiece ponding, and
pour out the ponding.
Whether everyone
use their Accessories
by themselves
It must avoid cross infection. Everyone must use their Accessories
by themselves.
The Medicine of
Atomizing Cup is
leaking
Atomizing Cup is broken or plastic aging
Replace of new Atomizing Cup before
filling Medicine
* If you have tried the above solutions, and the device still cannot normally nebulizer, suggest to contact
your dealer.
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Chapter 8 Customer Service
If your intelligent mesh nebulizer is broken/damaged, and need to repair or any other user assistance,
please contact intelligent mesh nebulizer Customer Service:
Contact information:
Qingdao Future Medical Technology Co., Ltd.
Room 401 Building F , Changsheng Industrial Park, No.169 Zhuzhou Rd, Laoshan District, Qingdao City,
Shandong Province, China.
Tel/Fax: +86-532-55677725
E-mail: support@smartdean.com
1. Quality Assurance
One year for free warranty for Main Unit. But accessories as consumed products do not belong to
warranty range.
The details as following are not included in warranty range：
The damage caused by human fall, touch, soaking, wet
The damage caused by not in accordance with the correct operating instructions.
Damaged by accident.
Without our company's authority, users who disassemble and assemble by selves.
Products Serial No. is tear or can't be recognized well, and no warranty card and No Original
Invoice available.
NOTE! Take warranty card “Users Page” to contact local dealer or our company if your nebulizer needs
to be repaired. Meanwhile please keep packing box in safe place so that it can be used when you send it
to our company.
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Chapter 9 Product Specifications
Table3 Product Specifications
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Name Intelligent Mesh Nebulizer
Model NEB001
Applied part Mouthpiece or mask
Dimensions Approx. 50mm(L)×74mm(W)×111mm(H)
Weight 79±5g
Switching power supply
Model: HPU15-102. Input: 100-240Va.c. 47-63Hz 0.4-0.2A
Output: 5Vd.c. 2.4A Max.
It is considered as a part of equipment
Power Source Input: 5Vd.c. 1.5A Min.
ZN-103450 Lithium battery: 3.7Vd.c. 1800mAh
Safety Grade BF, Internally powered equipment
Power Consumption Approx.6W
Vibration Frequency Approx.110KHz
Nebulization Rate 0.2ml/min minimum
Medicine Temperature ≤60℃
Working Voice ≤50dB
Particle Size 3.5μm±25%
Medicine Capacity 8ml maximum,0.5ml minimum
Battery Life
the battery can be used for approximately 8 days after charging if
operating the device for 30 minutes a day and the battery cycle life
is 300 cycles.
rotected against the
ingress of water and
particulate matter
IP22
Guarantee Time Main Unit 1 Year( Atomizing Cupnot included);
Operating Temperature
Environmental temp:5 ~40 ,℃ ℃
Relative humidity : 15~90% RH, not in Coagulation situation
Air Pressure: (70.0～106.0)kPa
Storage and transport
Temperature
Environmental temperature: -25 ~70℃ ℃
Relative Humidity: ≤90%R.H.
Air Pressure: (70.0～106.0)kPa
Accessory Mouthpiece, Adult Mask, Child Mask, Adapter ,Instruction Manual
28
Fog particle equivalent volume (Picture 14)
NOTE!
1) It was tested by 0.9% physiological saline under the condition of temperature 25±3 ,humidity ℃
60%±5%R.H.
2) The horizontal line is particle diameter, the data are the logarithm distribution；Left vertical line is
cumulative percentage of volume, corresponding to the curve upward trend；Right vertical line is a range
of volume percentage, corresponding to Graph histogram or rolling.
Picture 14 Fog Particle Equivalent Volume
Chapter 10 Electromagnetic Compatibility
● Do not use the device in the direct vicinity of short-wave or microwave equipment.
● Do not connect this equipment to other equipment, Consult your physician for users wearing the heart
pacemaker.
1、Electromagnetic Compatibility
The Intelligent Mesh Nebulizer has been tested and found to comply with the limits for medical devices
in IEC 60601-1-2. These limits are designed to provide reasonable protection against harmful
29
interference in a typical medical installation.
If other devices cause harmful interference to this device, the user is encouraged to try to correct the
interference by one or more of the following measures:
● Reorient or relocate this device.
● Increase the separation between the interference equipment.
● Connect the equipment into an outlet on a circuit different from that to which the other device(s) are
connected.
● Consult the manufacturer for help.
Table 4 Guidance and manufacturer’s declaration-electromagnetic emissions
Item Applied standard Result
Emission Measurement
Radiated emission IEC 60601-1-2:2007
CISPR 11:2010 PASS
Conducted disturbance IEC 60601-1-2:2007
CISPR 11:2010 Not applicable
Harmonic current emission
(harmonic)
IEC 60601-1-2:2007
IEC 61000-3-2:2014 Not applicable
Voltage fluctuations &
Flicker (Flicker)
IEC 60601-1-2:2007
IEC 61000-3-3:2013 Not applicable
Immunity Measurement
Electrostatic discharge IEC 60601-1-2:2007
IEC 61000-4-2:2008 PASS
RF field strength
susceptibility
IEC 60601-1-2:2007
IEC 61000-4-3:2010 PASS
Electrical fast transients/burst
test
IEC 60601-1-2:2007
IEC 61000-4-4:2012 Not applicable
Surges test IEC 60601-1-2:2007
IEC 61000-4-5:2014 Not applicable
Conducted susceptibility test IEC 60601-1-2:2007
IEC 61000-4-6:2013 Not applicable
Power-frequency magnetic
field susceptibility test
IEC 60601-1-2:2007
IEC 61000-4-8:2009 PASS
Voltage dips and interruptions
test
IEC 60601-1-2:2007
IEC 61000-4-11:2004 Not applicable
30
2、 Notes on FCC certification
This device has been tested and found to comply with the limits for a Class B digital device, pursuant to
part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful
interference in a residential installation. This device generates uses and can radiate radio frequency
energy and, if not installed and used in accordance with the instructions, may cause harmful interference
to radio communications. However, there is no guarantee that interference will not occur in a particular
installation. If this device does cause harmful interference to radio or television reception, which can be
determined by turning the equipment off and on, the user is encouraged to try to correct the interference
by one or more of the following measures:
-Reorient or relocate the receiving antenna.
-Increase the separation between the equipment and receiver.
-Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
-Consult the dealer or an experienced for help.
This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions:
(1) This device may not cause harmful interference, and (2) this device must accept any interference
received, including interference that may cause undesired operation.
Any Changes or modifications not expressly approved by the party responsible for compliance could
void the user's authority to operate the device.
Chapter 11 Labeling
，
Marks and Symbols
1、Labeling
31
2、Marks and Symbols
CE mark
Lot number
Separate collection
Date of manufacture
See the Instruction
Manufacturer
BF type application part
European union
representative
Notice
Power Indicator
Low Liquid Indicator
Low Voltage Indicator
IP22 Waterproofing Grade
Environment-friendly
Use Period