Compressor Nebulizer
Model UN-019
Instruction ManualOriginal
Manuel dinstructions
Traduction
Manual de Instrucciones
Traducción
Manuale di Istruzioni
Traduzione
BedienungsanleitungÜbersetzung

1WMPD4004706

CONTENTS
1. DEAR CUSTOMERS .................................................................. Page 2
2. PRELIMINARY REMARKS ......................................................... Page 2
3. SYMBOLS ................................................................................... Page 2
4. IMPORTANT SAFEGUARDS ..................................................... Page 3
5. INTRODUCTION......................................................................... Page 5
6. SPECIFICATIONS ...................................................................... Page 57. PARTS IDENTIFICATION ........................................................... Page 68. OPERATING INSTRUCTIONS ................................................... Page 79. CLEANING .................................................................................. Page 810. MAINTENANCE .......................................................................... Page 811. TROUBLESHOOTING ................................................................ Page 912. TECHNICAL DATA .................................................................... Page 1013. EMD TECHNICAL DATA ........................................................... Page 1014. CORRECT DISPOSAL OF THIS PRODUCT(WASTE ELECTRICAL & ELECTRONIC EQUIPMENT)............. Page 13

English 1

1. DEAR CUSTOMERS
Thank you for purchasing the UN-019 Compressor Nebulizer.
This device is a compact medical device designed to deliver the medicationprescribed by your doctor.
The compressor creates a stream of air that travels through the clear tubing tothe nebulizer which generates a mist of medicinal particles small enough toreach the furthest parts of your lungs to provide maximum benefit for thetreatment of asthma, allergies and other respiratory disorders.
This device should be used only as directed. Do not use this device foranything other than as prescribed by your doctor.
Before use, read this instruction manual thoroughly.

2. PRELIMINARY REMARKSThis device conforms to the European Directive 93/42 EEC for Medical
Products. This is proved the CE conformity marking CE1639. (1639: The
identification number of the Notified Body.)

3. SYMBOLS
Symbols

Meaning
Caution Attention or Consult accompanying documents
Type BF Equipment
Alternating Current
Double Insulation
Indoor use only
Manufacturer
Refer to instruction manual
WEEE label
EU-representative

1639

EC directive medical device label

English 2

4. IMPORTANT SAFEGUARDSCAUTION:
1.

Federal Law restricts the sale or use of this device to an order by a physician.

2.

Follow the instructions of your physician when operating this device.

3.

This device is a nebulizer for the inhalation of medical aerosols and issuitable for solutions used by children. Use only the type and amount ofmedication prescribed by the patients doctor.

4.

This device is intended for aerosol therapy only. Any other use is notrecommended.

5.

Do not twist the air tube during operation.

6.

Do not pour more than 6ml of solution into the device.
DANGER: Risk of electrocution.

7.

Always disconnect the power cord from the electrical outlet immediately afterusing.

8.

Do not use while bathing.

9.

Do not place or store the unit where it can fall or be pulled into a tub orsink.

10. Do not place or drop the device into water or other liquid.
11. Do not reach for a product that has fallen into water. Disconnect the power cordfrom the electrical outlet immediately.

English 3

WARNING: Risk of burns, electrocution, fire or injury1.

Electrical Shock Hazard: Do not remove the cabinet or open the cover.

2.

Disconnect the power cord from the electrical outlet before cleaning orservicing.

3.

Do not place this device near hot, sparking or burning objects.

4.

Do not use oil or grease on or near this device.

5.

Turn the unit off when it is not in use.

6.

Keep the cord away from HEATED or HOT surfaces.

7.

NEVER drop or insert any object into any opening.

8.

NEVER block the air openings of the product or place it on a soft surface,such as a bed or couch, where the air openings may be blocked.

9.

Avoid operating in wet or damp locations.

10. Disconnect the power cord from the electrical outlet before filling thenebulizer cup.
11. When using this device near TVs, microwave ovens, pulse telephones, Xrays, or other strong electric field, there may be electrical interference. It isrecommended to be far away from these devices when using this device.
WARNING: Risk of infection
1.

This device is intended for both adult and pediatric patient use.

2.

Cleaning of the device is recommended after each aerosol treatment.
Disinfecting is recommended once a day. Please follow cleaning anddisinfecting instructions in this manual.

This device is not suitable for use in anesthetics breathing systems.
This device is not suitable for solutions in suspension or high viscosity
liquids. In such cases information should be sought from the drug supplier.

English 45. INTRODUCTION
This compressor nebulizer is designed to deliver a prescribed medication
solution to treat patient respiratory disorders, such as asthma, allergies andbronchitis. The device converts the medication solution into an aerosolizedmist which is inhaled by the patient through the mouthpiece or nosepiece ormask. Read this manual thoroughly before using the device and store it forfuture reference.

6. SPECIFICATIONSElectrical Requirements

230 V / 50 Hz

Power Consumption
Rated Current

Below 60 W
Below 0.70 A

Dimensions

Length 250mm × Width 118mm ×Height 175mm
1.4kg(3.09lbs)

WeightSound Pressure Level
Max. Compression Pressure
Neb. Operating Pressure
Liter Flow Range
Average Nebulization Rate:
Maximum nebulizer solution capacity

55 dBA35 psi to 50 psi (241 kPa to 345 kPa)
9-16 psi (62 kPa to 110 kPa)
5-8 L/minApprox. 0.33 ml/min (6 ml medicine
can be nebulized within 18 minutes)
6 ml

Maximum residual medicine volume
Particle size (MMAD)

0.5 mlApproximately 3 m

Operating Temperature/Humidity
Storage/Transport Temperature
Range/ Humidity+10°C to + 40°C, 30% RH to 85% RH

Operating and Storage/Transport
Atmospheric Pressure- 20°C to + 70°C, 10% RH to 95% RH
700 hPa to 1,060 hPa

Protection against electric shock- Classified as Type- Type BF applied parts: Mouthpiece, nosepiece, masks
Degree of safety in the presence of flammable anesthetics or oxygen No AP/APG (not suitable for use in the presence of flammable anesthetics oroxygen)
Mode of operation  Continuous
IP21  Protection against harmful ingress of water is Ordinary.

English 5

7. PARTS IDENTIFICATION
1.
2.
3.
4.
5.

Main unit
Adult maskChild mask
Mouthpiece
Nosepiece

6. Air tube
7. Nebulizer cup
8. Air filters
9. Instruction manual
10. Carrying pouch

123

4

56789

10

Filter cover

Power switch(" ":ON, " ":OFF)
Air outlet connector(Plug shape) C-plug: UN-019A-EC1B, BF-plug: UN-019A-EC2B
Replacement parts list
Appearance

Part name

Part code

Qty

Material

Adult mask

UNB-014A-01EC

1PVC

Child mask

UNB-014A-02EC

1PVC

Air tube

UNB-014A-03EC

1PVC

Air filter

UNB-014A-04EC

5urethane sponge

Nebulizer cup

UNB-014A-05EC

1

PP, SAN

Mouthpiece
Nosepiece

UNB-014A-11EC

1

PP

English 6

8. OPERATING INSTRUCTIONS
1.

Place the device on a stable, sturdy and flat surface so that the device
can be easily reached when you are seated.

2.

Make sure that the device is in the "Off" (O) position by pressing on theupper side of switch.

3.

Plug power cord into a wall outlet.

4.

Connect one end of the air tube into the air outlet connector on the device.

5.

Add the prescribed solution through the opening on the cup using an eye
dropper or pre-measured dose container.
The "6cc" marking on the nebulizer cup is the maximum level.
Medication cannot be filled beyond the maximum level.

6.

Insert the mouthpiece into the top of the nebulizer cup.
If nosepiece is used, insert it into the mouthpiece.
If a mask is used, connect the bottom of the mask to the top of thenebulizer cup.

7.

Connect another end of the air tube to nebulizer air inlet connector on thebottom of the nebulizer cup.

8.

Turn the power on to start the unit.

9.

Initiate the treatment by placing the mouthpiece between the teeth.
Inhale through the mouthpiece and exhale through your nose.
If nosepiece is used, inhale through the nosepiece and exhale your mouth.

10. If a mask is used, place the mask over the mouth and nose.

English 7

9. CLEANING
1.

Turn the power off and unplug from the wall outlet.

2.

Remove the air tube from the air inlet connectors.

3.

TO CLEAN: Remove the mouthpiece, nosepiece, mask, and disassemble thenebulizer cup (cup, cap, and baffle), and wash these items in hot water withdish-washing detergent. Rinse these items thoroughly to remove the detergent
and air dry.

4.

TO DISINFECT: Mix one part of white vinegar with 3 parts hot water in aclean container. Submerge mouthpiece, nosepiece, mask, and parts ofnebulizer cup for half an hour in the solution. Remove from solution and let
air dry.

5.

There is no need to clean the tube. If necessary wipe the surface regularly.

Note:Replace the nebulizer accessories including adult mask, child mask,mouthpiece, nosepiece, nebulizer cup, Air tube after using 6 months.
Replace the filter every 30 days or if the filter turns grey.
CAUTION: The device must be changed if it becomes clogged.
CAUTION: The device and accessories must not be boiled.

10. MAINTENANCE
1.

The air filter should be replaced when it turns gray. Additional filters can beprocured from your dealer.

2.

Only authorized personnel shall make repairs to this device.
CAUTION: The device may be damaged if used with a dirty filter or if
the air filter is replaced by some other material such as
cotton. Do NOT operate without the dedicated air filter.

English 8

11. TROUBLESHOOTING
Check the following if the device should fail during operation. You can also
refer to the pages of this manual for complete instructions.
Problem
Cause
RemedyNothing happens
when the powerswitch is pressed.

The power cord is notconnected correctly to theelectrical outlet.

Check that the plug is inserted inan electrical outlet. Unplug thenreinsert the plug if necessary.

No nebulization or
low nebulization
rate when thepower is on.

There is no medication inthe nebulizer cup.
There is too much/little
medication in the nebulizer
cup.
The cap of nebulizer cup is
missing or not assembledcorrectly.
The accessory for inhale is
not assembled correctly.
The nozzle of nebulizer cup
is blocked.
The nebulizer cup is tilted
at a sharp angle.

Add the correct amount ofmedication to the nebulizer
cup.

The air tube is notconnected correctly.
The air tube is folded ordamaged.
The air tube is blocked.
The air filter is dirty.
The device isabnormally loud.
The device is very
hot.

The air filter cover is not
attached correctly.
The device is covered bysomething.
The device was operated
continuously for over 20
minutes.

Attach the cap of nebulizer cupcorrectly.
Assemble the accessory forinhale correctly.
Make sure that the nozzle is freeof blockages.
Make sure that the nebulizer kit
is not tilted at an angle of morethan 45 degrees.
Make sure that the air tube iscorrectly connected to thecompressor and accessory
for inhale.
Make sure that the air tube does
not contain kinks.
Make sure that the air tube is
free of blockages.
Replace the air filter with a newone.
Attach the air filter covercorrectly.
Do not cover the device withany type of cover during use.
Limit use to 20 minutes at atime, and allow a 40 minute rest
interval before using the device
again.

NOTE: If the suggested remedy does not solve the problem, do not try
to repair the device. No parts of the unit are user serviceable.
Return the unit to an authorized retail outlet or distributor.

English 912. TECHNICAL DATAParticle Size: **MMAD * approximately 3 um
Appropriate Medication Quantities: 2 ml minimum  6 ml maximum
Nebulization rate: 0.33 ml/min (by weight loss)
Aerosol Output: **0.33 ml (2 ml, 1%NaF)
Aerosol Output Rate: **0.06 ml/min (2ml, 1%NaF)
Result of cascade impactor **measurements for particle size

MMAD = Mass Median Aerodynamic Diameter

13. EMD TECHNICAL DATA
Medical Electrical Equipment needs special precautions regarding EMD and needs
to be installed and put into service according to the EMD information provided inthe following.
Portable and mobile RF communication equipment (e.g. cell phones) can affect
Medical Electrical Equipment. The use of accessories and cables other than thosespecified may result in increased emissions or decreased immunity of the unit.

English 10

Table 1 - EMISSION Limits Phenomenon

Compliance

Conducted and radiated RF EMISSION CISPR 11

Group 1 Class B

Harmonic distortion

IEC 61000-3-2Class A

Voltage fluctuations and flicker

IEC 61000-3-3Compliance

Table 2 - IMMUNITY TEST LEVELS : Enclosure Port Phenomenon

IMMUNITY TEST LEVELSElectrostatic discharge
IEC 61000-4-2±8 kV contact±2 kV, ±4 kV, ±8 kV, ±15 kV air

Radiated RF EM fields
IEC 61000-4-3

10 V/m80 MHz - 2.7 GHz
80 % AM at 1 kHz

Proximity fields from RF wireless communications
equipment IEC 61000-4-3

See table 4

Rated power frequency magnetic fields
IEC 61000-4-8

30 A/m50 Hz or 60 Hz

Table 3 - IMMUNITY TEST LEVELS : Input a.c. power Port Phenomenon
IMMUNITY TEST LEVELSElectrical fast transients / bursts
IEC 61000-4-4Surges Line-to-line IEC 61000-4-5
Conducted disturbances induced byRF fields IEC 61000-4-6Voltage dips IEC 61000-4-11±2 kV
100 kHz repetition frequency±0.5 kV, ±1 kV
3 V 0.15 MHz - 80 MHz
6 V in ISM and amateur radio bands between 0.15
MHz and 80 MHz 80 % AM at 1 kHz
0 % UT; 0.5 cycle
At 0°, 45°, 90°, 135°, 180°, 225°, 270°, and 315°
0 % UT; 1 cycle AndSingle phase: at 0°

70 % UT; 25/30 cycle

Voltage interruption IEC 61000-4-11 0% UT; 250/300 cycle
NOTE

UT is the AC mains voltage prior to application of the test level.

English 11Table 4 - Test specifications for ENCLOSURE PORT IMMUNITY to RF wirelesscommunications equipment Testfrequency(MHz)

Band(MHz)

ServiceModulation
Pulse
modulation
18 Hz
FM±5 kHzdeviation
1 kHz sine385

380 - 390TETRA 400450

430 - 470

GMRS 460
FRS 460

704 - 787

LTE Band 13,17

800 - 960

GSM 800/900
TETRA 800
iDEN 820CDMA 850
LTE Band 5710
745
780
810
870
930
1720
1845
1970
2450

GSM 1800
CDMA 1900
GSM 1900
1700 -1990
DECT
LTE Band 1,3,4,25
UMTS
Bluetooth
WLAN 802.11 b/g/n
2400 - 2570
RFID 2450
LTE Band 75240
5500
5785

5100 - 5800 WLAN 802.11 a/nMaximum
Distancepower(m)(W)

IMMUNITY

TEST
LEVEL
(V/m)

1.8

0.3

27

20.3

28

Pulse
modulation
217 Hz0.20.3

9Pulsemodulation
18 Hz

20.3

28

Pulse
modulation
217 Hz

20.3

28

Pulse
modulation
217 Hz

20.3

28

Pulse
modulation
217 Hz0.2

0.3

9English 12

14. CORRECT DISPOSAL OF THIS PRODUCT(WASTE ELECTRICAL & ELECTRONIC EQUIPMENT)This marking
shown on this product and its literature, indicates that itshould not be disposed of with other household wastes at the end of its
working life. To prevent possible harm to the environment or human healthfrom uncontrolled waste disposal, please separate this from other types ofwastes and recycle it responsibly to promote the sustainable reuse ofmaterial resources.
Household users should contact either the retailer where they purchased thisproduct, or their local government office for details of where and how they
can dispose this item for environmentally safe recycling.
This device does not contain any hazardous substances.

English 13

MEMO

English 14

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