B.Well TH-134 User manual

MESH NEBULIZER
MODEL: TH-134
MODEL: TH-135
Instructions for use
MESH NEBULIZER MODEL: TH-134 • TH-135
READ THIS INSTRUCTION
MANUAL CAREFULLY
BEFORE USE

Instructions for use TH-134 • TH-135
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MESH NEBULIZER
MODEL NO.: TH-134
MODEL NO.: TH-135
INSTRUCTION MANUAL
INDEX
1. Introduction ............................................................................................. Page 4
2. Intended purpose ..................................................................................... Page 4
3. Precautions .............................................................................................. Page 4
4. Notice for safety operation ....................................................................... Page 6
5. Name of component ................................................................................ Page 8
6. How to use ............................................................................................... Page 9
7. Clean and maintenance notice ............................................................... Page 10
8. Disinfection ............................................................................................ Page 11
9. Trouble Shooting..................................................................................... Page 11
10. The accessories ...................................................................................... Page 12
11. Specications ........................................................................................ Page 13
12. Symbol information ............................................................................... Page 14
13. Latest revision........................................................................................ Page 14

Instructions for use TH-134 • TH-135
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1. INTRODUCTION
Dear Customer,
This manual contains important information you must know about the product.
Please read it thoroughly before use. Please keep this manual with you.
The Nebulizer’s quality will be dierent by dierent medicine characteristic;
the ow rate may be varied. Besides, when medicine is in low temperature that
ow rate will be decrease.
2. INTENDED PURPOSE
Medical purpose This product is intended to be used for inhaling medication
for respiratory disorders.
Intended user Legally certified medical experts, such as doctor, nurse and
therapist, or healthcare personnel or patient under the
guidance of qualified medical experts.
Environment This product is intended for use in a medical facility, such
as Hospital, clinic and doctor’s office, in a room of general
household, and in open-air environment with a roof.
Durable period Durable periods are as follows. Durable period may vary
depending on usage environment.
Main body – 2 years
Medical cup, Mouth piece, Mask – 6 months
3. PRECAUTIONS
When using an electronic appliance, basic precautions should always be followed, includ-
ing the following:
1. Close supervision is necessary when this appliance is used by, on or near children,
handicapped persons or invalids. Besides, the dosage and frequency of the use also has
to be specified by the prescribing physician.
2. Do not operate under the blanket or pillow. Excessive heating can occur and cause fire,
electric shock, or injury to persons.

Instructions for use TH-134 • TH-135
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3. Use this appliance only for its intended use as described in this manual.
4. Do not use cotton swabs or other objects to touch the mesh; otherwise, product will
not operate.
5. Do not use different type batteries in the same time.
6. Do not carry or store the product which is still remaining medicine in medical cup.
7. For the type, dose, and regimen of the medication, be sure to follow the instructions of
a doctor.
8. Do not immerse them in water.
9. Do not use disinfection solution containing sodium hypochlorite.
10. Do not inhale by using water in the medication bottle.
11. Do not drop or apply strong shock to the Main unit.
12. Do not use any attachments or accessories not recommended by the manufacturer.
13. Discard the waste batteries and device according to local law.
14.When environment temperature raised to 40ºC the product shelf temperature will raise
up to 50ºC.
15. Do not use nebulizer on top of or close to other electronic device.
16. Do not drop the nebulizer. Do not apply strong shocks to the nebulizer.
FEATURE:
1. This product utilizes ultrasonic vibration to turn liquid drug into fine mist which is then
sent to the respiratory tract and oral cavity by a venting system so that therapeutic
result can be achieved.
2. Compact and easily to carry.
3. Ultrasonic vibration which produces 100,000 ~120,000 vibrations per second.
4. After 20-minutes continuously operation or when the medical cup is no medicine,
the appliance will automatic shutdown. However, the no-medication detector has the
possibility not function if that mesh blocked by medication.
5. Built-in low-battery indicator.
6. No matter use the product in different angle, that still can operate normally in short term.
When put the product upside down, medicine cannot contact to mesh, the product still can
operate normally in few seconds (it can be different if different medicine is in using).

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4. NOTICE FOR SAFETY OPERATION
To ensure safety, please do follow all rules below:
1. Before using
• Use this appliance in the correct manners outlined in this manual.
• This appliance had to operate under nominal temperature (10ºC ~ 40ºC), outside the
nominal temperature range was not suitable to operate the product.
• Before Using, please proceed with cleaning procedure described in the cleaning and
maintenance procedure.
• The medicine treatment should according to doctor’s advice.
• If the product operates improperly, please discontinue use it and send it for repairing
immediately or consult your dealer.
• If the medical cup is not functioning very well (such as very weak spray volume etc.),
before using, please replace it.
• When this appliance has not been used for a while, if any part (such as medical cup,
mouth piece or mask) seems dirty, please proceed with cleaning procedure described
in the cleaning and maintenance procedure.
• Do not add medicine over the indicated line marked on medical cup (8c.c marking).
• Do not disassemble or make any modification on this appliance.
2. Under using
• Children or disable patients should be assisted by adults or medical personnel when
using this appliance.
• Do not use this appliance under a high humid environment (>85% RH)
• Do not use this product if the medical cup without any medicine.
• Keep the appliance in flat position and steady during operation to avoid spillage.
• Do not open the cover of medical cup during operation.
• Keep eyes away from the mist output.
• Treatment period please follow the doctor’s advice.

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• Different patients should use individual clean medical cups and mouth pieces to avoid
cross infection.
• Some medicine dose not nebulizes well, please consult with your doctor.
• This appliance has a low-battery indicator.When the indicator light is green, the power
is good for working.When the power light turns to orange, the battery is become
weak, but you still can use product, however you may need to replace battery soon. If
the power light is turns red it means voltage is too low to operate, please replace the
battery immediately.
• During using this appliance, if any irregularity or discomfort is observed, please discon-
tinue use this appliance.
• This product has built-in a 20-minute shutoff timer. If it cannot be shutoff automati-
cally, discontinue using and consult your dealer for help.
• If product detects no medicine in the medical cup, the LED indicator will turn red and
flash three times then shutoff automatically
• When under using, you can use the product in any angles. But, make sure medicine has
good contact with mesh.
3. After using
• Please clean all parts after each usage and do follow instruction in the manual.
• Do not immerse this appliance in water when cleaning to avoid damaging any electri-
cal parts.
• Do not store this appliance in direct sunlight, outside our suggestion storage tempera-
ture and humidity environment.
• Keep this product from the reach of children.

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1. Power button: press to turn on or off
the appliance.
2. Indicator Light: Indicate the power
condition.
(Green for normal/Orange for battery
weak/Red for exhausted battery) and also
showing is there still have medicine inside
the medical cup. If there is no medicine in-
side, indicator light will turn red and flash
three times before turn off automatically.
However, the no-medication detector has
the possibility not function if that mesh
blocked by medication.
3. Medical Cup: Contain the medicine.
(Suggestion: Replace a new medical
cup per year)
4. Push button: push here to release the
medical cup from the main body.
5. Medical cup cover: open here to pour
the medicine.
6. For Mouthpiece or Mask
7. Mesh
8. Battery cover: open here to replace
battery.
9. Main body
10. Mask
11. Mouthpiece
12. Adapter
5. NAME OF COMPONENT
9
1
2
7
6
3
4
5
11
12
10
8

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6. HOW TO USE
1. Make sure that all parts such as mouthpiece or mask, medical cup are clean, or clean
the above three parts before using.
2. Open the battery cover and put in batteries.
(The battery life varied by using different brands of battery)
Suggestion: Use Alkaline batteries or Ni-MH rechargeable Batteries (option).
1. Remove batteries if the unit is not in use for long periods. Failure to do so
could result in damage due to battery leakage.
2. Discard the waste batteries according to local law.
3. Open the medical cup cover and pour the medicine
into the medical cup and close the cover completely.
4. Install mask or mouthpiece properly and start using the appliance.
• When the power button is pressed and the
appliance starts working the green light
will on (sometimes, in orange and which
depend on battery power remained) and
the build in timer will start to countdown.
• If the indicator turns orange, it shows the
battery is weak. If the appliance is activated
and the power indicator turns to red, it

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means the batteries are exhausted and the appliance cannot operate properly. Please
replace with new battery immediately.
• If there is no medicine inside the medical cup, indicator light will turn red and flash
three times before appliance turning off automatically.
7. CLEAN AND MAINTENANCE NOTICE
Before and after each using, please clean the following parts:
1. Remove the medical cup and mouthpiece or mask. Discard all remaining medi-
cine in the cup.
• Open the medical cap and discard all remaining medicine.
• Pour in some hot water and close the cover completely.
• Press the power button and operate 1~2 minutes to discard all remaining medicine
completely.
Ensure medicine be cleaned completely after each using, otherwise, it could cause
mesh blocked.
2. Clean the surface of main body of appli-
ance with cotton swabs or a piece of fFne
cotton fabrics.
Please clean the electrode in the main body
and medical cup, ensure normally electrical
conduction.
Please do not use easily volatility liquid to
clean the electrode, ex. Benzene, thinner.
3. Clean the medical cup, mouthpiece and mask with clean water and store at a
safety place after cleaning the surface with ethanol.
Suggestion: Use a new medical cup for different illness or patients to avoid cross
infection.

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8. DISINFECTION
Medical cup can be disinfected by boiling in hot water. After 3-4 minutes of boiling, shake
off excessive water from the cup and let them dry on a clean, lint free (paper) towel.
Main unit, mask, mouth piece can Not be boiled.
9. TROUBLE SHOOTING:
After checking the followings, if any problem still persists, please return the appliance to
your dealer for servicing.
Cause of failure Causes and reaction measures
Push power
button, but
no operation
1. Check if the battery voltage is sufficient?
When the appliance’s red indicator light is on, the battery
power is too low. Please replace the battery immediately.
2. Discard the waste batteries according to local law.
3. Check the battery is installed correctly?
Open battery cover and check if the battery electrode is rusted
or not.
Cannot
nebulize or
not enough
mist output
1. Check if the medical cup is filled with appropriate amount of
medicine?
2. The mesh in medical cup blocked by remaining medicine.
Cleaning medical cup, if still can’t solve problem, please replace
a new medical cup.
3. The mesh surface (mesh output) has covered by water or
medication.
Remove water or medication from mesh surface.
4. Medical cup is not installing properly.
Release the medical cup from main body and push it back again.
Suggestion: Replace a new medical cup per year.

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10. THE ACCESSORIES
Model No. Size
Child Mask PY-001-MS 87.22 × 64.35 × 57 mm
Adult Mask PY-001-ML 124 × 77 × 68.5 mm
Mouth Piece PY-001-MP 43 × 27.5 mm
Medical Cup (Gray) PY-001-MC 54 × 43.99 × 38.50 mm
Medical Cup (Blue) PY-001-B-MC 54 × 43.99 × 38.50 mm
AC Adaptor PY-AE/AU 95 × 44 × 65 mm
ELECTROMAGNETIC COMPATIBILITY
Many electronic devices are used in our near environment.Your nebulizer is susceptible
to electromagnetic interference from these electronic devices. These interferences may
cause incorrect functioning of the nebulizer and can generate unsafe situations. In order
to prevent such unsafe situations, your nebulizer is designed and tested according to
EN60601-1-2 standards.These standards define the levels of immunity to a device from
electromagnetic interference as well as maximum levels of electromagnetic emissions from
the medical device.The electromagnetic emissions of your nebulizer are extremely low,
however, special precautions should be observed:
• It is recommended that you do not place the device on top of or close to other devices
(such as mobile phone). Should you notice any interference with other electrical
devices, keep the device away from those electronic devices.
EMC DECLARATION SHEET

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11. SPECIFICATIONS
Model Number TH-134 • TH-135
Power Supply 1.5V × 2 AA Size Alkaline battery
or AC adaptor (optional).
Input: 100~240VAC, 0.3-0.15A, 50~60 Hz
Output: 3VDC, 1.33A
Power Consumption < 2W
Active current consumption < 650 mA
Standby current consumption < 0.35mA
Battery life Continue operation: 1 hour (min)
for brand new 1.5V × 2, AA, Alkaline battery
or Ni-MH rechargeable Batteries (option).
Full battery indication > 2.2V, green light
Weak battery indication 2.0V ~2.2V, orange light
Low battery indication < 2.0V, red light
Operation environment 10~40°C, 30%~80% RH
Storage/Transportation environment -20~70°C, ≤85% RH
Nebulization rate 0.2mL/min, ~1.0mL/min(Max)
Time AUTO-OFF Power on, operate 20 min.Then auto-off
Nebulizer auto-off No medication
Medication bottle volume 2~8 mL (Max.)
Mesh oscillation frequency 103kHz - 123kHz ±1kHz
Particle Size appr. 5mikrom (MMAD)
The method of measuring
particle size is according to
EN 13544-1:2007 Annex CC
• Particle size: about 5μm
• Nebulization rate:
within 0.2~1.0 ml/min
(by weight loss)
• Aerosol output:
0.866 ml (2ml, 1% (M/V). NaF)
• Aerosol output rate:
0.102 ml/min (2ml, 1% (M/V). NaF)
• Sound: Less than 30dB Aerodynamic diameter

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Reusable parts life Medical cup, Mask, Mouthpiece: 6 months
According as reliability test result –
One time per day
Dimension (L ×W × H): 45 × 54 × 122 mm
The specifications may be changed without prior notice.
12. SYMBOL INFORMATION
symbol referent
Read instructions before use
Manufacturer’s Name
Article number
Serial number
Class II Equipment
Type BF equipment
Disposal for separate collection
CE mark
Protection degree against ingress of water and solid material
Manufacturing date decoded in SN number:
the first two numbers is week
the second two numbers is year
13. LATEST REVISION
Date of issue: 27 February 2012
Latest revision: 2016/05/16

•
B.Well Swiss AG
Bahnhofstrasse 24, CH-9443Widnau, Switzerland
ISO9001 & ISO13485 Certified
This device complies with European Council Directive 93/42/EEC on Medical Devices

B.Well Swiss AG
Bahnhofstrasse 24, CH-9443 Widnau,
Switzerland
IM_TH-134_TH-135_ISO_2616