SUNSET NEB402 User manual
Instruction Manual
NEB402
Handheld Mesh Nebulizer
IFU-00059 REV 1.00
2022-05-17
Manufactured for
Sunset Healthcare Solutions
180 N Michigan Ave Ste 2000
Chicago, IL 60601
3
Thank you very much for choosing Handheld Mesh Nebulizer.
Please read this user manual carefully before using, so that you
can use it safely and correctly. Please keep this user manual
properly in place for future reading.
4
Table of Contents
1. Important Safety Notes....................................................................5
2. Intended Use.................................................................................... 5
3. Contraindications.............................................................................. 5
4. Package Contents & Overview........................................................ 5
5. Product Technical Parameters......................................................... 6
6. User Instructions.............................................................................. 7
7. Cleaning & Disinfection..................................................................10
8. Storage Conditions.........................................................................12
9. Trouble Shooting............................................................................12
10. Note & Warning............................................................................13
11. EMC Declarations...........................................................................14
12. Signs & Symbols........................................................................... 21
13. After-sales Service....................................................................... 23
14. Disclaimer Clause......................................................................... 24
15. Warranty card
16. Certificate Of Inspection
............................................................................... 25
.................................................................. 26
17. FCC Statement.............................................................................. 27
5
1. Important Safety Notes
a. For the type, dose and regimen of the medication, please follow the
instruction from your medical doctor.
b. Please operate the device as intended.
c. This unit is only used for nebulization.
d. Please clean and disinfect the medication cup and accessories before
using each time.
e. Please stop using the device if it is damaged or becomes wet.
The device is a Vibrating Mesh Nebulizer System designed to aerosolize
liquid medication for inhalation therapy by the patient. The device may
be used with pediatric patients older than 5 years of age and adult
patients in home healthcare facility environment.
Pentamidine is not permitted.
2. Intended Use
3. Contraindications
None.
4. Package Contents & Overview
4.1 Package Contents
Figure 1 Package Contents
User Manual
Portable Bag
Mask
Micro USB Cable
Nebulizer Mouthpiece
Warranty Card
6
4.2 Product Contents
Figure 2 Product Contents
5. Product Technical Parameters
Device Name Handheld Mesh Nebulizer
Power Supply DC 4.8V (2×2.4V rechargeable Li-ion
batteries) or DC 5.0V 1.0A with AC adapter
Power Consumption <3.0W
Nebulization Rate 0.25ml/min~0.9ml/min
Particle Size MMAD ＜5μm
Medication Cup Capacity 10ml (Max)
Vibration Frequency 110kHz±10kHz
Weight 100g with batteries
Size Length 38.5mm × Width 53.4mm × High 97.7mm
Working Environment
Temperature: +41℉to +104℉(+5 ℃to
+40 ℃) Relative Humidity: 30%~80%R.H.
Atmospheric pressure: (86.0~106.0) kPa
A. Medication Cover
B. Medication Cup
C. Spray Nozzle
D. Main Unit
E. Power Switch
F. Slide
G. PRESS Switch
H. Micro USB Cable
A
B
D
C
E
G
H
F
℉ ℉
7
Storage Environment
Time Auto-off Power on, operate 10 mins, then auto-off
Temperature: +14 to +122 (-10℃to
+50 ℃) Relative Humidity: 30%~80%R.H.
Atmospheric pressure: (86.0~106.0) kPa
Table 1 Technical Parameters
Durable Period:
Durable periods are as follows, provided the product is used to nebulize
medication 3 times a day for 10 minutes each time at temperature +77 ℉
(25 °C).
Durable period may vary depending on usage environment.
Main Unit 2 years
Top Cover 2 years
Medication Cup 2 years
Medication Cover 2 years
Mask (PVC) 1 year
The nebulizer has a USB cable for charging, it does not include a power adapter.
If using an alternate charger, please use an IEC 60601-1 approved AC adapter
(output: DC 5.0V 1.0A).
The power system of the device runs on a rechargeable lithium battery.
When the device indicates low power, please charge it via USB cable (As shown
in Figure 3 below).
6. User Instructions
6.1 Power Supply
Figure 3 Power Supply Connection
Green light flashes
Green light flashes 3 times
Green light flashes 5 times
Green light flashes 10 times
The battery group can supply power up to 60 minutes continually after
full charging.
When the battery power is below 3.8V, the green LED light will keep
flashing, until the nebulizer powers off automatically. When low power is
indicated, please recharge the battery for 1.5 hours. During charging, the
green LED light flashes. When charging completes, the green LED light
will display solid. When the device is working, the blue LED light will
display solid.
8
6.2 Battery Charging
Note:
We recommend charging the device every 2 days to ensure normal use.
Continue charging the device at least once per month when not in use for
more than one month.
The rechargeable battery should not be replaced by the user, only by the
manufacturer.
The device cannot work when charging.
Step One:
Please refer to the Section 7 to do the Cleaning & Disinfection.
Step Two:
Open the medication cover and fill the medication cup with liquid medication.
Please see the Figure 4 Filling Procedure for reference.
Warning:
Please dispose of the device with the used batteries according to the local
environmental regulation.
6.3 Use Instructions
The light indicates the summary form
Green light keeps on Working
No liquid, shut down
Battery low, shut down
Set time for 10 minutes,
shut down
Charging
Green light keeps on Full charge
9
Figure 4 Filling Procedure
Step Three:
Connect mask or mouthpiece as in Figure 5 below, and click ON/OFF
switch to power on.
Please hold the nebulizer to keep liquid medication in contact with the
vibrating mesh, and the stream of inhalation, Please see Figure 6 below.
Figure 5 Connect Mask or Mouthpiece
Figure 6 Inhalation
Inhalation by mask Inhalation by mouthpiece
a. Remove the mask or mouthpiece from the main unit.
b. Pour a small amount of clean water into the medication cup and
When finishing nebulization, press ON/OFF switch to power off. Pour out the
residual liquid medication from the medication cup. Please see Figure 7 below.
Clean after use:
Clean and disinfect the main unit, medication cover, medication cup and mask or
mouthpiece by the method on the Section 7 (Please refer to the Section 7 Cleaning
& Disinfection).
Before and after use, be sure to clean and disinfect the main unit, medication cover,
medication cup and mask or mouthpiece. We recommend one device be used and
reused for a single person. And the device is not provided sterile.
10
Step Four:
Figure 7 Pouring out the Residual Liquid Medication
Step Five:
Note:
a.Please keep the device vertical and do not shake during the operation.
b.Holding inhaled breath for a short while can enhance the effectiveness of
nebulization therapy.
c.The medication liquid sometimes will be congealed on spray connector and
mesh disc, which will influence the nebulization rate. We recommended
stopping nebulization, removing mask or mouthpiece, and using clean
medical gauze to clean the residue.
d. Please contact manufacturer with any additional questions for use.
7. Cleaning & Disinfection
7.1 Cleaning
PRESS Button
close the medication cover. Soak the medication cup for 5 minutes.
c.Turn on the device to nebulize the clean water for 1 to 2 minutes to remove
residual medication from the mesh.
d.Turn off the device and disassemble the medication cover and medication cup
from the main unit.
e. Please clean the casing of the main unit by moistening a clean medical gauze
with clean water and immediately drying using clean medical gauze. Also clean
the electrodes with clean medical gauze.
f. Please rinse the mask or mouthpiece, medication cover and medication cup
with clean water for at least 5 minutes.
g. Please use clean medical gauze to dry after rinsing.
h. Please store the device in a clean and dry storage environment.
The waterproof classification of main unit is IP22, it cannot be washed. Prevent
water from entering unit.
Following the cleaning instructions after each use will prevent any remaining
medication in the bottle from drying, adhering to the mesh cap, and resulting
in the device not nebulizing effectively.
Please don't use the disinfectant of benzalkonium bromide or house bleach.
Never use Sodium hypochlorite, Hypochlorous acid or quaternary ammonium
compound to disinfect.
After cleaning, the components: medication cover, medication cup, and mask
or mouthpiece should be disinfected as the instruction below:
a. Lift open the medication cover and pour a small amount of 2% hydrogen
peroxide solution into the medication cup.
b. Turn on the device to nebulize the 2% hydrogen peroxide solution for 1 to 2
minutes.
c. Please soak the components listed in solution of 2% hydrogen peroxide for
10 minutes at 68 ℉(20℃);
d. Please rinse with distilled water for at least 5 minutes.
e. Please dry with clean medical gauze gently.
f. Please assemble the device.
g. Please store the device in a clean and dry storage environment.
11
Note:
7.2 Disinfection
Note:
Other manuals for NEB402
2
Table of contents
Other SUNSET Respiratory Product manuals
