Omron | NE-U100 | manual | Omron NE-U100 Portable MicroAir® Nebulizer Manual

Omron NE-U100 Portable MicroAir® Nebulizer Manual
Instruction manual
Vibrating Mesh Nebulizer NE-U100
For single patient use only
EN
ES
Rx ONLY
3608884-7B
Table of contents
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3
Important Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4
1. Know Your Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8
1.1 Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8
1.2 Name and Functions of the Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
2. Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
2.1 %HIRUHXVLQJWKHGHYLFHIRUWKH¿UVWWLPH. . . . . . . . . . . . . . . . . . . . . . . . . 11
2.2 How to clean the device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
2.3 How to insert or replace the batteries . . . . . . . . . . . . . . . . . . . . . . . . . . .13
2.4 Using the AC adapter (Optional) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15
2.5 +RZWRDVVHPEOHWKHGHYLFHDQG¿OOWKHPHGLFDWLRQFRQWDLQHU . . . . . . . .17
3. Using Your Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21
3.1 How to Inhale . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21
3.2 How to Clean the Device After Each Use . . . . . . . . . . . . . . . . . . . . . . . .24
3.3 How to Store . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .27
4. Troubleshooting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .28
5. Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .30
5.1 How to Replace the Mesh Cap . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .30
5.2 Carrying Your Device with Storage Case . . . . . . . . . . . . . . . . . . . . . . . .30
5.3 Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .31
6. Optional Medical Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .31
7. 6SHFL¿FDWLRQV . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .32
8. FCC Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .36
9. Limited Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .37
10. Guidance and Manufacturer’s Declaration . . . . . . . . . . . . . . . . . . . . . . . . .38
2
Introduction
Thank you for purchasing the Omron® MICROAir® NE-U100.
Omron Healthcare has moved forward in the development of electronic nebulizer technology with
the introduction of the MICROAir NE-U100. Focusing on patient convenience and compliance as
its goal, this device offers ultimate portability and a revolutionary vibrating mesh technology that
provides a precise, powerful and effective treatment.
„ Safety Instructions
This instruction manual provides you with important information about the OMRON NE-U100. To
ensure the safe and proper use of this device, READ and UNDERSTAND all of the safety and
operating instructions. If you do not understand these instructions or have any questions,
FRQWDFWEHIRUHDWWHPSWLQJWRXVHWKLVGHYLFH)RUVSHFL¿FLQIRUPDWLRQDERXW
your own respiratory health, consult with your physician.
EN
„ Intended Use
The Omron NE-U100 is an ultrasonic (vibrating mesh) nebulizer system designed to aerosolize liquid
medications for inhalation by the patient. The device may be used with pediatric and adult patients in
the home, hospital, and sub-acute care settings.
It is not intended for use with Pentamidine.
„ Receiving and Inspection
Remove this device from the packaging and inspect for damage. If this device is damaged, DO NOT
USE and contact 1-800-634-4350.
„ Symbols Glossary
For symbol information, visit: OmronHealthcare.com/symbols-glossary
3
Important Safety Information
Please read the Important Safety Information in this instruction manual before using this
device.
Please follow this instruction manual thoroughly for your safety.
3OHDVHNHHSIRUIXWXUHUHIHUHQFH)RUVSHFL¿FLQIRUPDWLRQDERXW\RXURZQGHYLFH&2168/7:,7+
YOUR PHYSICIAN.
a potentially hazardous situation which, if not avoided, could result in
Warning: Indicates
death or serious injury.
‡Failure to properly clean the MICROAir components will result in the risk of bacterial growth,
serious illness from contamination, and compromised medication delivery.
‡For type, dose, and regimen of medication, follow the instructions of your physician and/or licensed
healthcare practitioner.
‡DO NOT use Pentamidine with this device.
‡,I\RXH[SHULHQFHDQ\DOOHUJLFUHDFWLRQVRURWKHUGLI¿FXOWLHVGXULQJXVHVWRSXVLQJWKLVGHYLFH
immediately and consult your physician.
‡Keep this device out of the reach of unsupervised infants, toddlers and children. This device
contains small parts that may cause a choking hazard if swallowed by infants, toddlers or children.
‡$/:$<6GLVSRVHRIDQ\UHPDLQLQJPHGLFDWLRQDIWHUXVH$/:$<6XVHIUHVKPHGLFDWLRQIRUHDFK
treatment.
‡DO NOT use this device on persons who are unconscious or not breathing spontaneously.
‡DO NOT use water only in the nebulizer for inhaling purposes.
‡DO NOT touch the vibrating element while the power is on.
‡'2127XVHWKLVGHYLFHZKHUHLWPD\EHH[SRVHGWRÀDPPDEOHJDVRUYDSRUV
‡DO NOT use or store this device in humid locations such as a bathroom.
‡DO NOT leave this device or its parts in locations that are exposed to extreme temperature or
humidity changes such as in a vehicle or in direct sunlight.
‡DO NOT use in anesthetic or ventilator breathing circuits.
‡&OHDQWKHSDUWVRIWKLVGHYLFHEHIRUHXVLQJWKLVGHYLFHIRUWKH¿UVWWLPHDIWHUWKLVGHYLFHKDVQRW
been used for an extended period of time and when parts are contaminated.
‡Clean the parts of this device after each use.
4
Important Safety Information
‡Allow the parts to dry after cleaning before reassembling and store in a clean location so that this
device will not become contaminated.
‡DO NOT immerse the main unit (except the vibrating element and the area around the vibrating
element) and the AC adapter in water or other liquid.
‡DO NOT spill water or medication on the main unit and the AC adapter.
‡DO NOT leave the cleaning solution in the parts. Rinse the parts with clean tap water after
cleaning.
‡Store this device and the components in a clean, safe location.
AC Adapter (optional accessory) Handling and Usage
EN
‡DO NOT use the AC adapter if this device or the AC adapter cable is damaged. If this device or the
cable is damaged, turn off the power and unplug the AC adapter immediately.
‡Plug the AC adapter into the appropriate voltage outlet. DO NOT use in a multi-outlet plug.
‡NEVER plug in or unplug the AC adapter from the electric outlet with wet hands.
‡DO NOT disassemble or attempt to repair the AC adapter.
Caution:
Indicates a potentially hazardous situation which, if not avoided, may result
in minor or moderate injury to the user or patient, or cause damage to the
equipment or other property.
‡This device is intended for human use only.
‡To avoid the medication residue on the face, be sure to wipe the face after removing the mask.
‡DO NOT get nebulized medication in your eyes.
‡DO NOT operate this device if the medication container is empty.
‡8VH21/<2PURQDXWKRUL]HGSDUWVDQGDFFHVVRULHV 5HIHUWRVHFWLRQ 3DUWVDQGDFFHVVRULHVQRW
approved for use with this device may damage the unit.
‡DO NOT add more than 10ml of medication to the medication container.
‡'2127VXEMHFWWKHGHYLFHWRDQ\VWURQJVKRFNVVXFKDVGURSSLQJWKHGHYLFHRQWKHÀRRU
‡DO NOT cover the main unit with items such as a blanket or towel during use.
‡DO NOT disassemble or attempt to repair the main unit or AC adapter.
‡DO NOT push or poke at the mesh with items such as a cotton swab or pin.
5
Important Safety Information
‡:KLOHXVLQJWKLVGHYLFHPDNHVXUHWKDWQRPRELOHSKRQHRUDQ\RWKHUHOHFWULFDOGHYLFHVWKDWHPLW
HOHFWURPDJQHWLF¿HOGVLVZLWKLQLQFKHV FP 7KLVPD\UHVXOWLQGDPDJHWRWKHSHUIRUPDQFHRI
the device.
‡Inspect the main unit and the parts before each use to ensure that parts are not damaged, the
device is assembled properly and it is operating normally.
‡To prevent damage to the device, add the medication slowly. DO NOT allow the medication to
RYHUÀRZWKH0HGLFDWLRQ3RUW
‡To prevent damage to the device, make sure that the Mesh Cap is correctly in place. If the Mesh
Cap is not properly closed, medication will leak out of the device.
‡DO NOT operate the device at temperatures greater than +104°F (+40°C).
‡Operate the device only as intended. DO NOT use the device for any other purpose.
‡&KDQJHVRUPRGL¿FDWLRQVQRWDSSURYHGE\2PURQ+HDOWKFDUHZLOOYRLGWKHXVHUZDUUDQW\
‡Dry the parts by air drying only. DO NOT use any equipment to dry the device parts.
‡To prevent damage to the device, DO NOT immerse the Main Unit in any liquid, DO NOT wash or
rinse any of the parts under strong running water, and DO NOT touch the mesh with your hand or
any object.
‡7RSUHYHQWGDPDJHWRWKHGHYLFH'2127FDUU\RUOHDYHWKH0HGLFDWLRQ&RQWDLQHU¿OOHGZLWK
medication or distilled water.
‡DO NOT use household bleach to clean the device or parts; doing so will cause rust and damage
the Mesh Cap.
‡To prevent damage to the device, DO NOT clean the Main Unit using abrasive cleaners or any type
of chemical.
‡NEVER clean with benzene or thinner.
‡Ensure that this device has acclimated to room temperature before nebulizing the medication.
Nebulizing the medication after an extreme temperature change could lead to less nebulization.
OMRON recommends waiting for approximately 2 hours for the device to warm up or cool
GRZQZKHQWKHGHYLFHLVXVHGDWDQHQYLURQPHQWZLWKLQWKHWHPSHUDWXUHVSHFL¿HGDVRSHUDWLQJ
conditions after it is stored either at the maximum or at the minimum storage temperature.
For additional information of operating and storage/transport temperature, refer to section 7.
6
Important Safety Information
AC Adapter (optional accessory) Handling and Usage
‡Fully insert the AC adapter into the outlet. DO NOT use an extension cord.
‡:KHQXQSOXJJLQJWKH$&DGDSWHUIURPWKHRXWOHWEHVXUHWRVDIHO\SXOOIURPWKH$&DGDSWHU'2
NOT pull from the AC adapter cable.
‡:KHQKDQGOLQJWKH$&DGDSWHUFDEOH
DO NOT damage it.
DO NOT break it.
DO NOT tamper with it.
DO NOT forcibly bend or pull it.
DO NOT twist it.
DO NOT use it if it is gathered in a bundle.
DO NOT pinch it.
DO NOT place it under heavy objects.
‡:LSHDQ\GXVWRIIRIWKH$&DGDSWHU
‡Unplug the AC adapter when not in use.
‡Unplug the AC adapter before cleaning this device.
‡DO NOT put the AC Adapter in the Storage Case. The Storage Case is not intended to carry the
AC Adapter.
‡8VH21/<WKH$&DGDSWHUGHVLJQHGE\2PURQIRUWKLVGHYLFH 6HHSDJH31 for optional
accessories). Use of any other AC adapter may damage the device.
EN
Battery Handling and Usage
‡Replace old batteries with new ones immediately. Replace both batteries at the same time.
‡Remove the batteries if the unit will not be used for three months or more.
‡DO NOT use different types of batteries together.
‡DO NOT use new and used batteries together.
‡DO NOT use lithium batteries.
7
1. Know Your Device
1.1 Contents
The following items are contained in the package:
Main Unit Cover
Batteries
(2 “AA” alkaline
batteries)
8
Main Unit
Medication
Container
Child Mask (PVC)
Mesh Cap
Storage Case
Mask Adapter
Mouthpiece
Instruction Manual
1. Know Your Device
1.2 Name and Functions of the Parts
Mesh Cap
Contains metal alloy mesh for nebulization.
Mesh
Nebulized medication exits here through minute pores.
Medication Container
EN
Air opening
Stabilizes nebulization.
Main Unit
Medication container lid release button
Medication container can be opened when the buttons on
both sides are pressed.
Vibrating element
The tip of this vibrating element oscillates at high frequency
and pushes the medication through the pores of the mesh.
Power indicator
A green light turns on when the power is on.
ON/OFF ( ) button
Battery Low Indicator
An orange light blinks when the batteries are low.
9
1. Know Your Device
Rear View
Battery Cover release button
Battery Cover
Main Unit Cover
Protects the Main Unit with the
attached Medication Container
and Mesh Cap during storage.
Removing the main unit cover
Remove with pressing
mark.
10
2. Preparation
2.1 Before using the device for the first time
:DUQLQJ:
‡Failure to properly clean the MICROAir components will result in the risk of bacterial growth,
serious illness from contamination, compromised medication delivery.
‡&OHDQWKHSDUWVRIWKLVGHYLFHEHIRUHXVLQJWKLVGHYLFHIRUWKH¿UVWWLPHDIWHUWKLVGHYLFHKDVQRW
been used for an extended period of time and when parts are contaminated.
%HIRUH¿UVWXVH &DUHIXOO\UHDGWKHLQVWUXFWLRQPDQXDO
EN
- Disassemble the parts and clean the mesh cap,
medication container, mouthpiece, mask, mask
adapter and vibrating element and its surrounding
surface as shown below.
- Dry all parts completely before assembling the device.
Disassembly
11
2. Preparation
2.2 How to clean the device
‡Mesh Cap
:DVKWKHPHVKFDSLQPLOG QHXWUDO GHWHUJHQWWKHQULQVHRII
with distilled water. Remove excess water and allow to air dry in
a clean place.
Some types of medications may remain on the mesh.
Make sure to clean the medication from the mesh. Do not wash
under running water.
‡Medication Container, Mouthpiece, Mask and Mask Adapter
:DVKWKHPHGLFDWLRQFRQWDLQHUPRXWKSLHFHPDVNDQGPDVNDGDSWHULQ
distilled water and mild (neutral) detergent.
Rinse the medication container, mouthpiece, mask and mask adapter
thoroughly with distilled water and allow to air dry in a clean place.
Note: Remove the elastic band from the mask
before cleaning.
‡Vibrating element and its surrounding surface
:DVKXQGHUUXQQLQJWDSZDWHU
Note: To prevent liquid from entering the device,
make sure that the battery cover is locked in
place.
‡Main Unit
Clean the main unit by wiping it off with a (moistened) lint free cloth.
Use a dry lint free cloth to wipe the main unit dry.
Never clean with benzene or thinner.
12
2. Preparation
2.3 How to insert or replace the batteries
Caution:
‡DO NOT use new and used batteries together.
‡DO NOT use different types of batteries together.
‡DO NOT use lithium batteries.
‡Replace old batteries with new ones immediately. Replace both batteries at the same time.
‡Remove the batteries if the unit will not be used for three months or more.
1. Remove the battery cover on bottom side by pressing on the
release buttons on both sides.
EN
2. Insert the batteries according to the battery polarity indicated
inside the battery compartment.
3. Replace battery cover by pressing buttons on both sides of the
battery cover.
13
2. Preparation
Battery life and battery replacement
The unit can operate with alkaline batteries or with nickel-metal-hydride (NiMH) rechargeable
batteries. Depending on the capacity and condition of the batteries, the unit can operate up to
4 hours on a set of alkaline batteries.
Battery Low Indicator (orange light)
Notes:
14
Flashes
The batteries are low. Replace both batteries with new ones.
Turns on
The batteries are depleted. The device will not nebulize. Immediately
replace both batteries with new ones.
‡The battery low indicator will turn off if no button is pressed for 10
seconds or if you turn off the device.
‡Batteries should be treated as chemical waste; disposal should be done
at your retail store or at appropriate collection locations.
2. Preparation
2.4 Using the AC adapter (Optional)
:DUQLQJ:
‡DO NOT use the AC adapter if this device or the AC adapter cable is damaged. If this device or
the cable is damaged, turn off the power and unplug the AC adapter immediately.
‡Plug the AC adapter into the appropriate voltage outlet. DO NOT use in a multi-outlet plug.
‡NEVER plug in or unplug the AC adapter from the electric outlet with wet hands.
‡DO NOT disassemble or attempt to repair the AC adapter.
EN
Caution:
‡Fully insert the AC adapter onto the outlet. DO NOT use an extension cord.
‡:KHQXQSOXJJLQJWKH$&DGDSWHUIURPWKHRXWOHWEHVXUHWRVDIHO\SXOOIURPWKH$&DGDSWHU'2
NOT pull from the AC adapter cable.
‡:KHQKDQGOLQJWKH$&DGDSWHUFDEOH
DO NOT damage it.
DO NOT break it.
DO NOT tamper with it.
DO NOT forcibly bend or pull it.
DO NOT twist it.
DO NOT use it if it is gathered in a bundle.
DO NOT pinch it.
DO NOT place it under heavy objects.
‡:LSHDQ\GXVWRIIRIWKH$&DGDSWHU
‡Unplug the AC adapter when not in use.
‡Unplug the AC adapter before cleaning this device.
‡DO NOT put the AC adapter in the Storage Case. The Storage Case is not intended to carry the
AC adapter.
‡8VH21/<WKH$&DGDSWHUGHVLJQHGE\2PURQIURPWKLVGHYLFH 6HHSDJH31 for optional
accessories). Use of any other AC adapter may damage the device.
15
2. Preparation
To connect the AC adapter to the main unit
(1) Remove the battery cover and take out the
batteries (see page 13).
(2) Place the main unit on the AC adapter connection
stand as shown in the illustration on the right.
(2)
Note: It will click and lock to the stand.
(3)
(3) Insert the AC adapter power plug into an outlet.
Note: Do not place the device in a location where it is
GLI¿FXOWWRGLVFRQQHFWWKH$&DGDSWHU
Connection is completed.
To remove the AC adapter from the main unit
(4) Disconnect the AC adapter power plug from the outlet.
(6) Remove
(4) Unplug
(5) Push on both sides of the connection stand to unlock from
the main unit.
(6) Remove the main unit.
(5) Push both ends
16
2. Preparation
2.5 How to assemble the device and fill the medication container
1. Insert batteries or connect the optional AC adapter to the main unit, see page 13.
2. Align the mark on the medication container with the mark on the main unit. Push down and rotate
the medication container clockwise.
EN
Note: Do not assemble the medication container to the main unit when the mesh cap is installed.
3. Open the medication container by pressing on both sides of the lid.
17
2. Preparation
4. Fill the medication container as illustrated. The maximum
capacity is 10 ml.
:DUQLQJ:
‡DO NOT use Pentamidine with this device.
‡DO NOT use water only in the nebulizer for inhaling
purposes.
Caution:
‡DO NOT add more than 10 ml of medication to the medication
container.
‡To prevent damage to the device, add the medication slowly.
'2127DOORZWKHPHGLFDWLRQWRRYHUÀRZWKH0HGLFDWLRQ3RUW
5. Place the mesh cap on the medication container (See right
image).
Note: Do not touch the mesh.
18
Mesh
2. Preparation
6. Push the lid of medication container into place until it clicks.
0HVK&DSLV¿[HG
Caution: To prevent damage to the device, make sure that
the Mesh Cap is correctly in place. If the Mesh Cap
is not properly closed, medication will leak out of the
device.
Click
s.
EN
7. Install the mask adapter on the main unit.
19
2. Preparation
8. Install the mask or mouthpiece on the mask adapter.
The device is now ready for use.
Refer to sub-section 3.1 for How to Inhale.
20
3. Using Your Device
3.1 How to Inhale
:DUQLQJ:
‡For type, dose, and regimen of medication follow the instructions of your physician and/or
licensed healthcare practitioner.
‡$/:$<6GLVSRVHRIDQ\UHPDLQLQJPHGLFDWLRQDIWHUXVH$/:$<6XVHIUHVKPHGLFDWLRQIRU
each treatment.
‡This device contains small parts that may cause a choking hazard if swallowed by infants,
toddlers or children.
EN
Caution:
‡Inspect the main unit and the parts before each use to ensure that parts are not damaged, the
device is assembled properly and it is operating normally.
‡Do not operate the device at temperatures greater than +104º F (+40º C).
6OLJKWO\WLOWWKHXQLWDVLOOXVWUDWHGLQWKH¿JXUH
In this position, the vibrating element is immersed in the
medication and nebulization will start after the device is
powered on.
Medication
After the vibrating element has been immersed in the
medication, the unit can be used at any angle.
Notes:
‡In some positions, nebulization may stop after a short while, In
WKDWFDVHEULHÀ\WLOWWKHXQLWLQRUGHUWRLPPHUVHWKHYLEUDWLQJ
element in the medication.
‡If the vibrator is not immersed in the medication, when the
ON/OFF Button is pressed:
- the battery life may be shortened or
- WKH%DWWHU\/RZ,QGLFDWRUPD\ÀDVK
- WKH%DWWHU\/RZ,QGLFDWRUPD\WXUQRQ
- a metallic noise may be heard, which is normal
Vibrating element
21
3. Using Your Device
2. Place the mouthpiece in your mouth or place the mask over
your mouth and nose.
3. Press the ON/OFF ( ) button to start treatment and inhale
medication as directed by your physician and/or licensed
healthcare practitioner.
The green power indicator lights up during nebulization.
4. Press the ON/OFF ( ) button to turn off the device when
¿QLVKHGWKHWUHDWPHQW
Note: Unplug the power cord from the electrical outlet after
using the device.
22
3. Using Your Device
Note: If high viscosity medication such as Acetylcysteine is used,
nebulization may be reduced.
If excessive medication collects on the mesh, nebulization may
stop. In that case, turn off the power and remove the mask
DGDSWHU:LSHRIIWKHPHGLFDWLRQXVLQJDOLQWIUHHFORWK
:LSHWKHPHGLFDWLRQ
Caution: DO NOT push or poke at the mesh with items such as
a cotton swab or pin.
EN
After inhalation always switch off the nebulizer by pressing the ON/OFF ( ) button.
Note: The device automatically turns off after 30 minutes.
23
3. Using Your Device
3.2 How to Clean the Device After Each Use
The following items should be disassembled and cleaned after each use in order to prevent
any remaining medication in the container from drying or adhering to the mesh cap which will
result in ineffective nebulization.
Main unit, medication container, mesh cap, mask adapter, mouthpiece and mask.
:DUQLQJ:
‡Failure to properly clean the MICROAir components will result in the risk of bacterial growth,
serious illness from contamination, compromised medication delivery.
‡Do not leave the cleaning solution on the nebulizer parts. Rinse the nebulizer parts with clean
tap water after cleaning.
‡Allow the parts to dry after cleaning before reassembling and store in a clean location so that
this device will not become contaminated.
‡Do not immerse the main unit (except the vibrating element and the area around the vibrating
element) and the AC adapter in water or other liquid.
1. Remove the mask adapter from the main unit by pressing both
sides of the mask adapter.
24
3. Using Your Device
2. Open the medication container and remove the mesh cap.
Note: Do not touch the mesh.
EN
3. Discard the medication, then re-install the mesh cap.
Mesh
25
3. Using Your Device
4. Fill the medication container with water and close the lid of
medication container. Nebulize the distilled water for 1 to
2 minutes to prevent medication from drying and adhering to
the mesh after use.
:DWHU
Do not inhale water.
5. Open the lid of medication container and remove the mesh cap from the medication container,
then disassemble the medication container from the main unit by rotating counter-clockwise and
pulling-up.
Note: Remove the medication container AFTER discarding the medication.
6. Clean the device.
Refer to sub-section 2.2.
26
3. Using Your Device
3.3 How to Store
1. Make sure all cleaned components are completely dry.
2. Assemble the device.
3. Store the device in Storage Case (see page 30) or in a clean environment.
EN
27
4. Troubleshooting
,QFDVHRIDQ\RIWKHEHORZSUREOHPVRFFXUGXULQJXVH¿UVWFKHFNWKDWQRRWKHUHOHFWULFDOGHYLFHLV
within 12 inches (30cm).
If the problem persists, please refer to the table below.
Problem
The nebulization rate is
extremely low.
The green power
indicator does not turn
on and the unit does not
nebulize.
28
Possible cause
Solution
Batteries are low (the orange
EDWWHU\ORZLQGLFDWRUÀDVKHV Replace the batteries with new
ones. Refer to sub-section 2.3.
The mesh is stained or clogged.
1. Clean the mesh. Refer to subsection 2.2.
2. Replace the mesh cap with a new
one. Refer to sub-section 2.5.
The batteries are depleted (the
orange battery low indicator turns
on).
Replace the batteries with new ones
or use the AC adapter(Optional).
Refer to sub-section 2.3 and 2.4.
The capacity of rechargeable
batteries is low.
Charge the batteries with a
commercially available recharger.
The batteries are inserted in the
wrong direction.
Re-insert the batteries in the correct
direction. Refer to sub-section 2.3.
The AC adapter (Optional) is not
connected correctly to a power
outlet.
Check that the AC adapter is
connected to a power outlet and
main unit. Unplug then reinsert the
plug if necessary.
The contact on the AC adapter
(Optional) is contaminated.
:LSHDZD\DQ\FRQWDPLQDWLRQZLWKD
cloth that has been lightly moistened
with water or sanitizing alcohol. Dry
completely before use.
4. Troubleshooting
Problem
The green power
indicator turns on
but the unit does not
nebulize.
The green power
indicator turns on but
it nebulizes weakly, or
is taking too long for
treatment.
Possible cause
Solution
The vibrating element is not
immersed in the medication.
Tilt the main unit in order to
immerse the vibrating element in the
medication.
The medication container is not
¿OOHGZLWKPHGLFDWLRQ
Fill with medication. Refer to subsection 2.5.
The mesh is broken.
Replace with a new one. Refer to
sub-section 2.5.
Excessive medication is collected Remove excessive medication.
on the mesh
Refer to page 23.
Remove visible liquid with a soft
cloth and a very light touch so as
not to damage the mesh.
Nebulization rates vary based on
the medication used.
EN
Treatment times may vary among
medications and patients.
If the device does not nebulize properly after checking the possible causes above, contact customer
service 1-800-634-4350.
29
5. Maintenance
5.1 How to Replace the Mesh Cap
Omron recommends replacing the mesh cap after approximately 1 year (Please refer to section 7
“Durable period”).
Remove the mesh cap and install a new one as described on sub-section 2.5.
5.2 Carrying Your Device with Storage Case
Caution:
‡To prevent damage to the device, DO NOT carry or leave the Medication Container with medication
or distilled water.
‡DO NOT put the AC Adapter in the Storage Case.
The Storage Case is not intended to carry the optional AC Adapter.
Assemble the device by attaching the Mesh Cap and Medication
Container to the Main Unit. Place the Main Unit Cover on the device.
Position the device in the Storage Case as shown in the illustration.
The Mouthpiece and Mask Adapter can be placed in the Storage Case
to carry with the Main Unit.
To carry the AC Adapter bundle the cable of the AC Adapter as shown
in the illustration.
30
5. Maintenance
5.3 Disposal
Dispose of the device, components and optional accessories according to applicable local
regulations.
6. Optional Medical Accessories
Product Description
Adult Mask (PVC)
EN
Model
9920
Child Mask (PVC)
9921
Mouthpiece
U22-1
Mask Adapter
U100-2
Medication Container
U100-3
Mesh Cap
U100-4
AC Adapter
U100-5
31
7. 6SHFL¿FDWLRQV
Product Category:
Product Description:
Model:
Rating:
Power Source:
Operating Mode:
Residual Volume:
Battery Life:
Operating Temperature/
Humidity/Air Pressure:
Storage and Transport
Temperature/Humidity:
Weight:
Dimensions:
Contents:
Nebulizers
Vibrating Mesh Nebulizer
NE-U100
:
3V
100-240V 0.12-0.05A 50-60Hz (Optional AC adapter)
2 “AA” alkaline batteries 1.5V
2 “AA” NiMH rechargeable batteries 1.2V
Continous Use
Approx. 0.5 ml
Approx. 4 hours
+50°F to +104°F (+10°C to +40°C), 30 to 85%RH (noncondensing), 800 - 1060hPa
-4°F to +140°F (-20°C to +60°C), 10 to 90%RH (non-condensing)
* Approx. 4.2 oz (120g) (excl. batteries)
$SSUR[ : [ + [ ' PP[PP[PP Main Unit, Main Unit Cover, Medication Container, Mesh Cap,
0DVN$GDSWHU0RXWKSLHFH%DWWHULHV $$/5 &KLOG0DVN 39& Storage Case, Instruction Manual
&ODVVL¿FDWLRQV
,QWHUQDOO\SRZHUHG0(HTXLSPHQW :KHQXVLQJRQO\WKHEDWWHULHV
&ODVV,,0(HTXLSPHQW :KHQXVLQJWKHRSWLRQDO$&DGDSWHU
Type BF (Applied part); Mouthpiece, Mask
,3 :KHQXVLQJRQO\WKHEDWWHULHV
,3 :KHQXVLQJWKHRSWLRQDO$&DGDSWHU
* Main Unit assembled with Medication Container and Mask Adapter
32
6SHFL¿FDWLRQV
Notes:
‡6XEMHFWWRWHFKQLFDOPRGL¿FDWLRQZLWKRXWSULRUQRWLFH
‡7KLV20521SURGXFWLVSURGXFHGXQGHUWKHVWULFWTXDOLW\V\VWHPRI20521+($/7+&$5(&R
/WG-DSDQ
‡7KHGHYLFHPD\QRWZRUNLIWKHWHPSHUDWXUHDQGYROWDJHFRQGLWLRQVDUHGLIIHUHQWWRZKDWLVGH¿QHG
LQWKHVSHFL¿FDWLRQV
EN
33
6SHFL¿FDWLRQV
Particle Size:
Medication Container Capacity:
Sound:
Nebulization rate:
Aerosol Output:
Aerosol Output Rate:
00$'$SSUR[ȝP
MMAD = Mass Median Aerodynamic Diameter
10 ml maximum
Approx. 20 dB
**Greater than 0.25 ml/min (by weight loss)
0.5 ml (2 ml, 1%NaF)
0.1 ml/min (2 ml, 1%NaF)
Notes:
‡The distribution of particle size and aerosol output are measured with 2.5% NaF aqueous solution.
The particle size distribution and aerosol output may vary by combination of product, medication
and ambient conditions such as temperature, humidity and atmospheric pressure.
‡Performance may vary with the mesh and medication used such as suspensions or high viscosity.
See medication supplier’s data sheet for further details.
‡Treatment time 5 minutes for 2 ml.
‡3DUWVDQGDFFHVVRULHVQRWDSSURYHGIRUXVHGRQRWPHHWWKHVHVSHFL¿FDWLRQV
‡'RQRWXVHWKHGHYLFHZKHUHLWPD\EHH[SRVHGWRÀDPPDEOHJDV
‡:LWKUHVSHFWWRHOHFWULFVKRFNDQGPHFKDQLFDOKD]DUGVRQO\LQDFFRUGDQFHZLWK$16,$$0,
ES60601-1:2005/(R)2012.
34
Pulmicort®
Intal®
Salbutamol®
MMAD (micron)
ȝ
ȝ
ȝ
GSD (geometric
standard deviation)
1.81
2.01
1.90
Respirable fraction
PDVVWRȝ 21.2%
28.8%
33.6%
6SHFL¿FDWLRQV
0HDVXUHGYDOXHVUHÀHFWLQWHUQDOGDWDREWDLQHGE\1(;7*(1(5$7,21,03$&725 1*, DFFRUGLQJWR
EN13544-1:2007 + A1:2009.
** The Nebulization rate is measured with saline 0.9% solution at 23°C at spray angle of 30° with 3 ml of
medication. It can vary with medication and ambient conditions.
Cumulative % particle mass of sodium fluoride under size
100
Cumulative Undersize %
90
80
70
EN
60
50
40
Individual
30
Average
20
10
MMAD 4.5 μm
0
0.1
1
10
100
Particle Size Dp (μm)
Durable period
Durable periods are as follows, provided the product is used to nebulize
a medication twice a day for 10 minutes each time at room temperature
(23°C).
Durable period may vary depending on usage environment.
Frequent use of the product may shorten the durable period.
Main Unit
AC Adapter (optional)
Medication Container
Mesh Cap
Mouthpiece
Mask (PVC)
Mask Adapter
5 years
5 years
1 year
1 year
1 year
1 year
1 year
35
8. FCC Statement
FCC CAUTION
&KDQJHVRUPRGL¿FDWLRQVQRWH[SUHVVO\DSSURYHGE\WKHSDUW\UHVSRQVLEOHIRUFRPSOLDQFHFRXOGYRLG
the user’s authority to operate the equipment.
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.
Note:
This equipment 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 equipment 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 equipment 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 radio/TV technician for help.
36
9. Limited Warranty
Your NE-U100 main unit, excluding the Main Unit Cover, Medication Container, Mesh Cap, Mask
Adapter, Mouthpiece, Batteries, Child Mask (PVC), and Storage Case is warranted to be free from
defects in materials and workmanship appearing within 2 years from the date of purchase, when
used in accordance with the instructions provided with the NE-U100.
7KHDERYHZDUUDQW\H[WHQGVRQO\WRWKHRULJLQDOUHWDLOSXUFKDVHU:HZLOOLQVSHFWDQGUHSODFH\RXU
unit without charge as deemed necessary by the above warranty. This is our only responsibility and
your only remedy under the above warranty.
To obtain warranty service contact Customer Service by calling 1-800-634-4350 for the address of
the inspection center and the return shipping and handling fee.
EN
Enclose the Proof of Purchase. Include a letter, with your name, address, phone number, and
GHVFULSWLRQRIWKHVSHFL¿FSUREOHP3DFNWKHSURGXFWFDUHIXOO\WRSUHYHQWGDPDJHLQWUDQVLW%HFDXVH
of possible loss in transit, we recommend insuring the product with return receipt requested.
THE FOREGOING IS THE SOLE WARRANTY PROVIDED BY OMRON IN CONNECTION WITH
THIS PRODUCT, AND OMRON HEREBY DISCLAIMS ANY OTHER WARRANTIES, EXPRESS
OR IMPLIED, INCLUDING IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS
FOR A PARTICULAR PURPOSE. IMPLIED WARRANTIES AND OTHER TERMS THAT MAY BE
IMPOSED BY LAW, IF ANY, ARE LIMITED IN DURATION TO THE PERIOD OF THE ABOVE
EXPRESS WARRANTY.
OMRON SHALL NOT BE LIABLE FOR LOSS OF USE OR ANY OTHER SPECIAL, INCIDENTAL,
CONSEQUENTIAL OR INDIRECT COSTS, EXPENSES OR DAMAGES.
7KLVZDUUDQW\SURYLGHV\RXZLWKVSHFL¿FOHJDOULJKWVDQG\RXPD\KDYHRWKHUULJKWVWKDWYDU\E\
jurisdiction. Because of special local requirements, some of the above limitations and exclusions
may not apply to you.
FOR CUSTOMER SERVICE
Visit our web site at:
Call toll free:
OmronHealthcare.com
1-800-634-4350
37
10. Guidance and Manufacturer’s Declaration
OMRON Mesh Nebulizer
Information for accompanying documents in the scope of IEC60601-1-2:2014
Important information regarding Electro Magnetic Compatibility (EMC)
1(8PDQXIDFWXUHGE\20521+($/7+&$5(&R/WGFRQIRUPVWR,(&
Electro Magnetic Compatibility (EMC) standard.
Further documentation in accordance with this EMC standard is available at OmronHealthcare.
com/emc.
38
Note
EN
39
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.XQRWVXER7HUDGRFKR0XNR.\RWR-$3$1
Distributed by:
20521+($/7+&$5(,1&
:HVW)LHOG&RXUW/DNH)RUHVW,/86$
OmronHealthcare.com
‹20521+($/7+&$5(,1&
0DGHLQ-DSDQ
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