CareMax Y31 Mesh Nebuliser User Manual

Instruction Manual

Mesh Nebulizer
(Model No. YS31)

Introduction

Thank you for purchasing YS31 mesh nebulizer (Hereinafter referred to the device), please read the manual carefully to make sure that you can operate it correctly and safely. Please store the manual well after reading it for later reading and referencing.
[Quality Assurance]
Main unit 12 months for free warranty, medicine bottle(including mesh plate) 3 months for free warranty. During warranty period, we depend on the damage to decide if maintenance is required or damaged part is to be changed. Accessories are consumables, and thus do not belong to warranty range. If you need to change, we recommend our company’s accessories. The details given below not including 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 teared or can’t be recognized well, and no warranty card and No Original Invoice available.

NOTE : Take Warranty Card to contact local distributor 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.

Product Introduction

1. Product Overview
   The device is designed for respiratory diseases treatment and respiratory tract infection prevention. The device is pushed by certain circuit frequency vibration to make piezoelectric ceramic vibrate harmony that caused high speed vibration of metal mesh. And the medicine liquid will be quickly popped through micro mesh hole of metal mesh plate to be countless micro atomizing particles. This will further transfer by inhalation treatment using masks or mouthpieces to patients’ respiratory system.

2. Components
   Main unit, Medicine bottle (including atomization tube and mesh plate),Accessories (mouthpiece, adult mask, child mask). Details see Picture I:

3. Available Range
   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 ENT (ear, nose, throat) diseases like chronic allergic rhinitis, acute laryngitis, acute phatyngitis, acute tonsillitis, etc. The nebulizer shall be used with face mask, and the face mask’s connection tube diameter shall be 20.0±0.1mm, therefore the face mask can be connected to the nebulizer tightly.

4. Applicable people scope
   The nebulizer is available to adults, aged people, infants and children must under adults supervision. The nebulizer can be used at homehold environment, and it complies with requirement of IEC 60601-1-11.
   Contraindications:

1. The device can not be applied to anesthesia breathing system and respiratory system.
2. Infants and children must under adults supervision.
3. Pentamidine is not applicable to the device.

5. Worldng Principle
   The device is pushed by certain circuit frequency vibration to make piezoelectric ceramic vibrate harmony that caused high speed vibration of metal mesh. And the medicine liquid will be quickly popped through micro mesh hole of metal mesh plate to be countless micro atomizing particles. This will further transfer by inhalation treatment using masks or mouthpieces to patients’ respiratory system.

6. Main Performance Index
   Please see Table 1,it was tested by 0.9% physiological saline under the condition of temperature 25±3º c ,humidity 60%±5%R.H. Fog particle equivalent volume (Picture 3)
   Tablel Main Performance Index

NOTE : 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.

 Operation

To prevent cross infection, the nebulizer is used only by one person Please clean and disinfect nebulizer when you first using it or before and after using, then dry it, see Chapter 3.
1, Connect the power supply
This nebulizer can both with batteries and mobile charger with Android 8.0 flat pin (purchase additionally)
1, Install batteries (Picture 4)

1. Open the battery cover;
2.  Insert the batteries according to the illustration of polarity ( 2 Alkaline AA Batteries) ;
3. Close the battery cover.

NOTE:

1. Please install batteries as per battery chamber polarity symbol.
2. Please do not use mix batteries of different styles or manufacturers or factories
3. Please remove the batteries if not using nebulizer.

2, Adapter using

1. Connect Android 8.0 output to Mobile Charger with similar type of flat pin( Picture 2);
2. Connect Mobile Charger to power.

NOTE:

1. Users should purchase Mobile Charger additionally, please note that the output port of Mobile Charger should match with the AC power required;
2. To ensure safe using, please use Mobile Chargers that meet the electrical safety standard GB 9706.1-2007 or IEC 60601-1;
3. Mobile Charger technical parameter should satisfy as below :
4. Input voltage: AC 100∼240V,50/60 Hz;
5. Output voltage: DC 3∼5V,1∼2A

2, Nebulizer Assembly

1. Please clean and disinfect nebulizer before using, then dry it, see chapter 3 in details)
2. Use One hand to hold the main unit, the other to hold the medicine bottle. push follow the slot until you hear a “Click” sound.(Picture 5 )

NOTE: If not assemble medicine bottle in right place, that may caused electrode couldn’t turn and nebulizer can’t work. Please keep main unit and medicine bottle clean (see chapter 3), or may cause nebulizer can’t work.

3, Add medicine liquid (Picture 6)

1. One hand to hold the main unit, the other to open medicine bottle buckle;
2. Put medical liquid in the medicine bottle and then;
3. Tighten the medicine bottle cover.

NOTE:

1. Suggestion: max medicine liquid 8m1, min 0.5m1
2. After putting medicine liquid in, prevent nebulizer shaking or inverted which may cause the leakage of medicine liquid.
3. Keep medicine liquid and mesh completely contacting to prevent mesh plate air shock.

4, Usage of Nebulizer

Nebulizer accessories are grouped as mouthpiece, adult mask and child mask. If need to be treated by the throat, please use the mouthpiece; meanwhile if need to be treated by nasal cavity / or throat, please choose a mask.

1. Connect mouthpiece and sending pipe of main unit as Picture 7,or connect mask and sending pipe of main unit as Picture 8;
   

2.  Push START/STOP button, the power indicator light (Blue Light) will ligh

3. Keep calm, relax and sit well, with the hand holding the nebulizer ; and slow breathing, to have more effective treatment:
   (1)When use mouthpiece, make the mouthpiece flat end into the mouth. so that the medicine liquid targeted to the affected area.
   (2)When use mask, make mask slightly close to face, better for cover: mouth:
   1. Treat by nose cavity, deep inhaling from nose cavity, exhalir
   2. Treat by throat, inhaling from mouth, exhaling from nose ca
   (3)During treatment, can both use 1 and 2.

NOTE:

1. Put 0.9% physiological saline into medicine bottle, after assembl: push START/STOP to test If it can’t work well(Chapter 6)
2. Please follow Picture 7 and Picture 8, by accessories’ corm( mouthpiece or mask.
3. Please use correctly using mouthpiece, don’t spray the liquid to your tongue.
4. Don’t swallow liquid and make sure liquid does not go direct to the affected area.
5. Improper gesture and not smooth breathing may cause respiratory passage blockage.
6. If no medicine liquid is left in medicine bottle, after turning on the nebulizer the indicator (Yellow Light) will shine for one second and then turn off by self While the medicine liquid is exhausted, the nebulizer will turn off by oneself
7. Slightly tilt the Main Unit toward yourself to immerse the Vibrating Mesh in the Medicine.
8.  When the Medicine is not much, tilt the device toward yourself by START/STOP side) , make the Medicine gathered in mesh plate, in order to make full use of the residual Medicine.
9. The device should avoid empty shock, in case of mesh plate broken.
10. When Low Voltage Indicator (Red Light) continue to slow flash, the power will run out, please change new Alkaline Batteries as soon as possible.
11. Do not strongly wave or vibrate the device in use, otherwise the device automatically shut down.
12. Pure water is not suitable for normal working mode, otherwise the device will not turn on

5, Turn Off The Power

1. Press the START/STOP button to turn off the power, the Power Indicator (Blue Light) will go out.
2. When the Mobile Charger is used, remove the power plug from the electrical outlet after using the device.

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 9; Hold the Medicine bottle by the other hand, remove the Medicine bottle along the slot ;
   

3. Open the lid, pour all the residual liquid medicine bottle, and promptly clean the device, allow the parts to air dry and store the device in a clean environment. See Chapters 3 and 4.

Cleaning and Disinfecting

• 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, medicine bottle and accessories have any remaining liquid or moisture.

Medicine bottle

1. Open the medicine bottle, and discard any residual medicine;

2. Pour a small amount of hot distilled water into the Medicine Bottle and close the Cap;
     NOTE: Suggest that the water temperature is 30-60r

3. Press the START/STOP button for 5 seconds, Power Indicator(Blue) and Low Water Indicator (Yellow Light) and Low Voltage Indicator (Red Light) constantly light. Turn on the device in cleaning pattern to nebulize the distilled water for I to 2 minutes to remove residual Medicine from the mesh holes.

4. Rinse the medicine bottle and Medical Cap with distilled water. Gently wipe off excess water with a soft clean cloth or allow the parts to air dry in a clean environment

5. Immerse the medicine bottle in 75% medical alcohol disinfecting at least 3 minutes. then remove the medicine bottle in a clean environment to dry and store.

NOTE:

1. Use medical gauze and medical cotton swabs to clean and disinfect
2. Do not wipe in tissue paper or other cloth, otherwise the mesh will not nebulize normally.
3. Do not wipe with the sharp object or touch the mesh.
4. Disinfect the Mesh after the last treatment of each day in the following solution: 2m1 Vinegar (I part white vinegar and 3 parts distilled water). OR 2m1 hot water (No more than 80 degrees C). Turn on the device to nebulize in the disinfecting solution until running out. Turn off the power, then soak the medicine bottle in vinegar or hot water for 3 minutes, then remove and rinse with pure water.
5. Do not use other household bleach to clean the device in addition to the above solution.

2. Cleaning the Main Unit

1. Gently wipe the Main Unit with 75% medical alcohol and wipe off excess water with a soft clean cloth;
2. Clean the electrodes connecting the Main Unit and medicine bottle , 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.
3. Cleaning and Disinfecting of Mouthpiece and Masks I. Remove the mouthpiece or masks; 2. Rinse the mouthpiece and Mask with pure water for 2 — 3 minutes(Water Temperature .S.50 ) ; 3. Dry moisture with medical gauze. 4. Wipe the mask and mouthpiece with 75% of medical alcohol at least 3 minutes to disinfect, and store to air dry.

NOTE:

1. Clean and disinfect all the parts.
2. Replace the aging/ broken mask or mouthpiece every one month or using over 90 times. In order to ensure the safety of your usage, please purchase the parts from the regular manufacturer.

Storage and Maintenance

1. Storage Conditions:
   (1) Temperature: – 20 ‘C ~ 55 C;
   (2) Relative Humidity: < 80% 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) The product’s validtiy is advised as 3 years.
   (2)Clean and disinfect the device after each using .Assemble the device. Store the device in the Storage Case or in a clean environment.
   Validity: The device is adviced used in 3 years and in 4000 times; For the battery, the device can be used for approximately 8 days if operating for 30 minutes a day, after this, another battery or charging of battery shall be provided.

2.Maintenance of the Device
1. Working Conditions
(1) Environment Temperature: 10 ‘C ~ 40 C;
(2) Relative Humidity: < 80% R.H., No condensation
(3) Air Pressure: 86.0 ~ 106.0 kPa;
(4) Power: DC 3V+ 10% (2 Alkaline AA Batteries) or Mobile Charger (Buy additionally, Technical Parameter Requirements see Chapter 2)
2. Maintenance Instructions
(1) Operate the device in normal work condition;
(2) Do not operate the device near the heating device or open fire. Do not dry the device and its accessories with the microwave oven, oven drying, hair dryer, etc.
(3) Don’t make the nebulizer and its accessories contact corrosive liquids or gases.
(4) Do not install the Main Unit around the power lines.
(5)Refer to Chapter 6 for solution or contact the company or purchase dealer when the device can not work.
WARNING: Prohibit to disassemble, repair or change the device.

 Safety Information and Care

1. Safety Information
   1. Do not use of store the device in humid locations, such as a bathroom. Use the device within the operating temperature and humidity.
   2. Read all the information in the instruction book and any other literature included in the box before using the unit.
   3. Accessories mentioned in the instruction manual are just for the device .
   4. Do not subject the device or any of the components to strong shocks, such as dropping on the floor.
   5. Do not shock the device in using.
   6. Do not disassemble or attempt to repair the device or components.
   7. Remove all batteries when the device does not work.
   8. When the Mobile Charger is used, remove the power plug from the electrical outlet and clean the device.
   9. Do not operate the device or contact the Mobile Charger socket or power switch with wet hands.
   10.Do not immerse the main unit in water or other liquid, avoid splashing water or other liquid to the main unit or AC adapter; Turn off the power, and immediately dry with a clean cloth.
   11.To prevent damage to the device, do not carry or leave the Medicine Bottle filled with Medicine or distilled water.
   12.Do not operate the device with rechargeable batteries, Dispose of the device, components, and optional accessories according to applicable local regulations.
   Unlawful disposal may case environmental pollution.
   13.This device is approved for human use only.

2. Care for the Device
   1.The nebulizer is a prescription medical device. For type or dose of Medicine follow the instructions of your physician and/or licenced healthcare practitioner
   2.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.
   3.The device nebulizes for 10 ~ 20 minutes each time, the amount of Medicine for 2 ~ 4 ml, but still can be used as the physician suggested.
   4.The device is a personal medical equipment, Do not mix its usage with others.
   5.Do not touch the mesh with your hand or any other object.
   6.Keep the device out of the reach of unsupervised infants and children.
   7.Suggest that the device be kept away from other electrical products with above 2W power consumption at least 3.3 meters, to avoid the electromagnetic interference; Consult your physician for users wearing the heart pacemaker.

WARNING: Pentamidine is not applicable to the device!
The device can not be applied to anesthesia breathing system and respiratory system!

Trouble Shooting

There are something problem in using the device, please find solutions in the following table.

The device is on but
nebulize weakly| The Medicine Bottle is not properly installed| Make sure the Medicine Bottle is
properly installed
The Medicine has not

come in contact with the

nebulizing parts above 10 seconds

| Adjust the nebulizer angle and connect with the Medicine
the mesh cap of Medicine bottle is not clean| Clean the Medicine bottle ,if still not work properly, change a new one
the electrodes of the Medicine bottle is not clean with liquid or Medicine| Clean the electrodes and start
the electrodes of the Medicine is not clean| Clean the electrodes and start
The power indicator
Flashes 1 second and
turn off| The Medicine Bottle is not properly installed.| Make sure the Medicine Bottle is properly installed
Without Medicine in bottle| Fill the Medicine Bottle with the

proper amount of prescribed Medicine

Medicine is not connected with the mesh cap| Adjust the nebulizer angle and connect with the Medicine
the electrodes of the Medicine is not clean| Clean the electrodes and start
The power indicator
does not light, and
the device not
nebulize| The batteries have not been inserted properly| Replace the batteries correctly
is very The battery          ry low| Replace the new battery and turn the device on
Mobile Charger and the device are not properly connected| Properly connect and turn the device on
Low voltage indicator constantly illuminate, battery power is very low| Replace the new battery, and turn the device on
The mesh of of the medicine bottle is broken| Replace      of new medicine     bottle before

filling Medicine

The electrodes of medicine bottle have Medicine or water| Clean Medicines or water, turn the device on
the electrodes of the medicine bottle is not clean| Clean the electrodes, turn the device on
The mesh of Medicine bottle is blocked with dirt| Clean      medicine bottle,     if still    can’t     use.

replace the new Medicine bottle

The device
automatically shut
down in use| The Medicine Bottle is not properly installed| Make sure the Medicine Bottle is properly installed and turn the device on
Medicines has been run out| Fill the Medicine Bottle with the proper amount of prescribed Medicine
Medicines did not contact with the mesh above 10 seconds| Adjust the angle of the device Medicine to connect with Medicine
strong wave or vibrate the device in use| Hold the device securely
medicine bottle cannot be used| Replace      of new        medicine     bottle before

filling Medicine

Medicine is running
out but the device
cannot automatically
power off| 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 electrodes of medicine bottle have Medicine or water| Press the START/STOP button to turn it off, and clean the remaining Medicines or water
the medicine bottle or electrodes is not clean| Press the START/STOP button to turn it off, and clean the electrodes
The Medicine bottle has something wrong| Purchase and replace a new medicine bottle
The Medicine of
medicine bottle is
leaking| medicine bottle is broken or plastic aging| Replace      of new medicine      bottle      before filling Medicine

• If you have tried the above solutions, and the device still cannot normally nebulize, suggest to contact your dealer.

Marks and Symbols.

| CE Mark| | Serial 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

Product Specifications

100-240V, 50/60 Hz, Output: 3V-5V DC, 1-2A)
Safety Grade| BF
Power Consumption| 1.5W
Vibration Frequency| 120KHz *10%
Nebulization Rate| ? 0.2m1/min
Medicine Temperature| 541r
Working Voice| 550dB
Particle Size| MMAD Slur: ±25%
Medicine Capacity| Max. 8m1, Min.0.5m1
Guarantee Time| Main Unit I Year ( medicine bottle not included); Medicine Bottle 3 Months
Operating Temperature| Environmental temp:I0 t-40 C, Relative humidity :5_80% RH, not in Coagulation situation Air Pressure: (86.0-106.0)kPa
Storage Temperature| Environmental temperature: -20 r-sst Relative Humidity:580%R.H. Air Pressure: 70.0-106.0 kPa
Accessory| Mouthpiece, Adult Mask, Child Mask,   Instruction       Manual, Certification, Warranty Card, Carry Pouch

 Guidance and manufacturer’s declaration-electromagnetic emissions

Item Applied standard                                              Result

Emission Measurement
Radiated emission| IEC 60601-1-2:2014 CISPR11:2009+A1:2010| PASS
Conducted disturbance| IBC 60601-1-2: 2014 CISPR11:2009+A1:2010| Not applicable
Harmonic     current emission

(harmonic)

| IEC 60601-1-2:2014

IEC 61000-3-2:2005+A1:2008+A2:2009

| Not applicable
Voltage         fluctuations         &

Flicker (Flicker)

| IEC 60601-1-2:2014
IEC 61000-3-3:2013| Not applicable
Immunity Measurement
Electrostatic discharge| IEC 60601-1-2: 2014
IEC 61000-4-2:2008| PASS
RF          field           strength

susceptibility

| IEC 60601-1-2:2014

IEC 61000-4-3:2006+A1:2007+A2:2010

| PASS
Electrical fast transients/burst test| IEC 60601-1-2:2014
IEC 61000-4-4:2012| Not applicable
Surges test| IEC 60601-1-2:2014
IEC 61000-4-5:2005| Not applicable
Conducted susceptibility test| IEC 60601-1-2:2014
IEC 61000-4-6:2013| Not applicable
Power-frequency        magnetic

field susceptibility test

| IEC 60601-1-2:2014
IEC 61000-4-8:2009| PASS
Voltage dips and interruptions test| 1EC 60601-1-2:2014 IEC 61000-4-11:2004| Not applicable

Contact information

Manufactured for Caremax Australia by:
Le Reve Healthcare Pty Ltd AKA Caremax
Factory 28, 25-39 Cook Road
Mitcham Victoria Australia
Web: www.caremax.com.au
Email: enquiries@caremax.com.au

Read User Manual Online (PDF format)

Download This Manual (PDF format)

Download this manual  >>