Avita NE10 User manual

Nebulizer
NE10
EN
RoHS REACH
MDSS GmbH
Schiffgraben 41
30175 Hannover Germany
AViTA Corporation
9F., No. 78, Sec. 1, Kwang Fu Rd.,
San Chung Dist., New Taipei City 24158, Taiwan
Importer
Distributor
INSTRUCTION MANUAL
Please read this instruction manual carefully
before using the device

Contents
Introduction ........................................................................................................................ 1
Important Information before Use ......................................................................................... 3
Product Identification ..................................................................................................... 5
Instruction for Use............................................................................................................ 6
Battery Supply.................................................................................................................... 7
Change Air Filter................................................................................................................ 8
Cleaning and Disinfecting............................................................................................. 9
Technical Specification .................................................................................................10
EMC Tables.........................................................................................................................11
Explanation of Symbols................................................................................................13

1
Introduction
This product is intended to be used for inhaling medication for respiratory
disorders such as asthma, chronic bronchitis, allergies and other respiratory
disorders.
1. Small size gives you privacy and convenience of the treatment.
2. Compact Design
This device is compact easy to hold and operate.
3. Battery Operated: strong & stable
Device Description
NE10 Nebulizer is a portable aerosol nebulizer electronically powered by an
external power adapter and by an internal rechargeable lithium polymer battery.
The compressed air, created by the membrane pump of the device, flows into the
nebulizer container kit. The air pressure forced the liquid through the nozzle where
it is atomized against a plate within the container. The device is equipped with a
mouthpiece to easily delivery the medical aerosol.
Intended for Use
NE 10 nebulizer is designed to aerosolize prescribed medication for inhalation by a
patient in both the homecare and healthcare settings. The nebulizer kit is intended
for multiple uses by single patient.
NE 10 is not intended to diagnose or replace a diagnosis provided by a physician's
advice or inhaler labels; patients are expected to always follow their doctor's
advice and inhaler labels. NE 10 does not act as a MDI medication dose counter
and does not include a dose counting function.
*MDI= Metered Dose Inhaler

2
Operating Principle
The medication that is pumped up through the medication channel is mixed with
compressed air which is generated by a compressor pump. The medication is
turned into fine particles and sprayed when in contact with the compressed air.
Intended User
1. Legally certified medical experts, such as doctor, nurse and therapist.
2. Caregiver or patient under the guidance of qualified medical experts for home
treatment.
3. The user should be capable of understanding general operation of the content
of instruction manual.
Intended Patient
This product should not be used on patients, who are unconscious or are not
breathing spontaneously.
Durable Period
Durable periods are as follows, provided the product is used to nebulize 2 ml of
medication twice a day for 7.5 minutes each time. Durable period may depend on
usage environment. Frequent use of the product may shorten the durable period.
Compressor (Main unit) 3 years
Mouthpiece 3 months
Air Filter 3 months
Mask 3 months

3
Important Information before Use
1. WARNING: Do not modify this equipment without authorization of the
manufacturer.
2. Do not expose the device to extreme temperature, very high humidity level, or direct
sunlight.
3. Avoid extreme stress, shock or accidental drop down.
4. Please replace all batteries when the power or/and the sound of the pump is getting
weak while using the device.
5. It is recommended to remove the batteries if the device will not be used for more than
one month.
6. The application of pressure by the device is intermittent. You shall keep pressing the
power button to start the device to operate. If you want to stop the device, just need to
release the power button to turn off the device.
7. The nebulizer is for inhaling medication for respiratory disorders only. Do not use
this device other than the intended purposes.
8. During the use of the device, should not hold his/ her breath.
9. If you feel anything unusual when using the device, stop and consult a doctor
immediately.
10. Do not use only water in the nebulizer for inhaling purposes
11. Always dispose of remaining medication after use, and use fresh medication each
time.
12. Store the parts in a clean location to avoid infection.
13. If any serious incident that has occurred in relation to the device should be reported
to the manufacturer and the competent authority of the Member State in which the user
is established.
14. If you would require any assistance during setting up, using or maintaining, please

4
contact the manufacturer.
15. CAUTION: Please keep this device away from pets, pests, and children.
16. CAUTION - Avoid potential allergic reactions, please avoid the front of scanner in
direct contact to patient's wound.
17. CAUTION: Please keep away from children and pets, because small parts may be
inhaled or swallowed.
18. CAUTION: This product should not be used on patients, who are unconscious or are
not breathing spontaneously.
19. The device is not suitable for use in an anaesthetic breathing system or a ventilator
breathing system.

5
Product Identification
1
Mouthpiece
2
Inhalation Top
3
Medication Tank
4
Child Mask
5
Front Case
6
Adult Mask
7
Air Filter Cover
*Air filter inside
8
Power Key
9
Vaporizer Head
10
Bottom Case

6
Instruction for Use
1. Remove the inhalation top with vaporizer head from the medication tank.
2. Add the correct amount of prescribed medication to the medication tank.
3. Make sure that the vaporizer head is securely attached to the inhalation top.
4. Rotate the inhalation top clockwise until the alignment mark on it and the
alignment mark on the medication tank are aligned, and they click in place.
5. Attach the mask, mouthpiece or optional nosepiece to the nebulizer kit
tightly.
6. Switch on the power button continuously and the nebulization is generated.
7. When the treatment is complete, release the power button.

7
Battery Supply
This device is powered with a built-in lithium battery. The battery can be charged
with the USB cord.
1. Connect Type-C end of USB cord to the device.
2. Connect Type-A end of UCB cord to the adapter.
3. The charge indicator light shows "BLUE" while charging the batter
4. When the battery is full, the charge indicator light shows "GREEN". Please plug
out the charger.
PRECAUTION:
1. DO NOT USE THE NEBULIZER WHILE CHARGING. THE NEBULIZER CANNOT
OPERATE WHILE CHARGING. WE DO NOT TAKE RESPONSIBILITY FOR USING
CHARGER OR ADAPTER INAPPROPRIATELY.
2. To ensure safe using, the adapter and electronic equipment with USB port
should meet the electrical safety standard IEC 60601-1 or IEC 62369-1-2018.

8
Change Air Filter
1. Pull the air filter cover off the device.
2. Change the air filter.
3. Put the air filter cover back in place.
CAUTION:
1. Use only AViTA air filters designed for this device. Do not operate without
air filter.
2. Do not wash or clean the air filter. If the air filter becomes wet, replace it.
Damp air filters can cause blockages.
3. There's no front or back orientation for the air filters.
4. Check the air filters are clean and free of dust before inserting them.

9
Cleaning and Disinfecting
Clean the parts after each use to remove residual medication. This could avoid
inefficient nebulization or infection.
Washable parts
1. Nebulizer Kit (Inhalation top, medication tank), Mask, Mouthpiece
Wash them with boiled water. Rinse them thoroughly with clean hot tap water for
5 minutes at 100℃and allow to air dry in a clean place.
2. Vaporizer head
Wash it with running water.
Non-washable parts
1. Compressor
Soft dry cloth and non-abrasive cleaners for the outer case of the compressor
2. Air filter
Do not wash or clean the air filter. If the air filter becomes wet, replace it. Damp
air filters can cause blockages.
CAUTION:
Always wash the vaporizer head after each use.
Do not use a brush or pin to clean the vaporizer head.
When disinfecting the parts by boiling, be sure to boil them in plenty of water.
Do not boil vaporizer head together with objects other than applicable nebulizer
accessories.
Disinfecting
Disinfect the parts once a week. If the parts are heavily stained, replace them with
new ones.

10
Technical Specification
1. Particle Size: approx.3.73 um
2. Nebulization Rate: approx. 0.25 ml/min
3. Noise: ≤ 65 dB(A)
4. Medication Cup Capacity：max. 5ml
5. Power Supply：Rechargeable Li-ion Polymer Battery.
6. Enclosure Degree of Ingress Protection：IP22
7. Dimension：185(L) x 72.5(W) x 54(H) mm
8. Weight：163g
9. Operating conditions:
+10 °C to +35 °C (41 - 95 ℉)
30% to 85% relative humidity (non-condensing)
Atmospheric pressure：700-1060 hPa
10. Storage conditions:
-20 °C to +60 °C (-4 - 140 ℉)
up to 95% relative humidity (non-condensing)
Atmospheric pressure：700-1060 hPa
11. Battery Operation Time: About 30 minutes
(Depends on different brand of batteries.)
12. Lifetime：3 years
13. Battery Shelf Life：3 years
15. Web Address: http://www.avita.com.tw/
16. Classification: Internal powered

11
EMC Tables
NE10 is intended for use in the electromagnetic environment specified below. The
customer or the user of NE10 must make sure that it is used in such an
environment.
Guidance and manufacturer’s declaration - Electromagnetic emissions
Phenomenon
Professional healthcare
facility environment a)
HOME HEALTHCARE
ENVIRONMENT a)
Conducted and radiated
RF MISSIONS
a)
CISPR 11
Group 1 Class B
Harmonic distortion
Not applicable
Voltage fluctuations and
flickering
Not applicable
a) The equipment is suitable for use in Home Health Environments and
Professional Health Care Environments limited to patient rooms and respiratory
treatment facilities in hospital or clinics. The more restrictive acceptance limits of
Group 1 Class B (CISPR 11) have been considered and applied. The equipment is
suitable for use in the mentioned environments when directly connected to the
Public Mains Network.
b) The test is not applicable in this environment unless the ME EQUIPMENT and
ME SYSTEM used will be connected to the PUBLIC MAINS NETWORK and the
power input is otherwise within the scope of the Basic EMC standard.
Guidance and manufacturer’s declaration - Electromagnetic immunity - Enclosure
port
Phenomenon
Basic EMC
standard or test
method
Immunity test levels
Professional
healthcare
facility
environment
HOME HEALTHCARE
ENVIRONMENT
ELECTROSTATIC
DISCHARGE
IEC 61000-4-2
± 8kV contact
± 2 kV, ±4kV ±, ±8 kV, ±15 kV air
Radiated RF EM
fields
IEC 61000-4-3
a)
10 V/m b) 80MHz - 2.7 GHz
80% AM at 1kHz
Proximity fields
from RF wireless
communications
equipment
IEC 61000-4-3
COMPLIANT
NOTE: Further information about distances
to be maintained between portable and
mobile RF communications equipment
(transmitters) and the NE10 can be
requested from supplier using the contact
information provided in this manual.

12
However, it is advisable to keep the
electromechanical aerosol equipment at an
adequate distance of, at least, 0.5 m from
mobile phones or other RF
communications transmitters to minimize
possible interference.
RATED power
frequency
magnetic fields.
IEC 61000-4-8
30 A/m c)
50 Hz or 60 Hz
a) The equipment is suitable for use in Home Health Environments and
Professional Health Care Environments limited to patient rooms and respiratory
treatment facilities in hospital or clinics. The more restrictive IMMUNITY
acceptance limits have been considered and applied.
b) Before modulation is applied.
c) This test level assumes a minimum distance of at least 15 cm between the ME
EQUIPMENT or ME SYSTEM and sources of power frequency magnetic fields.

13
Explanation of Symbols
The CE marking with the Registration Number of the
Notified Body. This denotes the compliance of Regulation
(EU) 2017/745
Medical Device
Manufacturer
Authorized representative in the European Community
Date of manufacture
(YYYY-MM-DD or YYYY-MM)
Batch code (YYMMWWWW)
WWWW: working sheet no.
Serial number (YYMWWWXXXXX)
WWW: working sheet no.; XXXXX: serial no.
Keep dry
Temperature limit
Humidity limitation
Atmospheric pressure limitation
Caution
Consult the instruction for use
Disposal information: Should you wish to dispose of the
article, do so in accordance with current regulations. Details
are available from your local authority. WEEE 2012/19/EU
Directives
RoHS
This product fulfilling the requirements of the RoHS

14
Directive 2011/65/EU.
REACH
This product fulfilling the requirements of the REACH
Directive EC 1907/2006 and its amendments, do not
contain Substances of Very High Concern in concentration
above the limit of 0.1 %. No substance(s) is/are present in
the parts of the product above the concentration of 0.1 %
weight by weight.
“ON/OFF”(push-push)
Device classification type BF
This product meets the basic safety and essential
performance requirements indicated in the IP22
conditioning test (protection against solid foreign objects of
12.5mm ∅and greater and against vertically falling water
drops when enclosure tiled up to 15°)
The empty, completely flat batteries must be disposed of
through specially designated collection boxes, recycling
points or electronics retailers. You are legally required to
dispose of the batteries.
Importer
Distributor
Model Number
Country of Manufacturer
Unique Device Identifier

15
NE10P-22287AV
Jun. 27, 2022