Yuwell 403 T User manual

WPP
The revision date:2018/05

200VA
Term of safety use:5 years(except for wearing consumable parts)
, 50Hz
BF application (Atomizer)

~
continuous operation

1. Cleaning
Following cleaning instructions after each use will prevent any remaining
medication in the tank from drying, resulting in the device nebulizing fectively
and also will help prevent infections.
First make sure the power switch is in the of position, and then unplug the
power cord from the power outlet. Unplug the tube from the air outlet, remove
the mouthpiece(mask), unscrew the nebulizer kit and discharge remaining
medication in medication tank.
Cleaning
1) Medication tank, mask and mouthpiece
Rinse with clean water or immerse in warm water for 15 minutes to ensure
hygienic cleaning. Add appropriate amount of vinegar in the water, and allow the
parts to air dry in a clean environment.
2) Main unit and air tube
Please wipe with moisturized cloth.
3) Methods for expelling the moisture inside the air tube
a) Make sure the air tube is connected to the main unit.
b) Remove the air tube from the medication tank.
c) Turn on the compressor and pump air through the air tube to expel the
moisture.
2. Disinfecting
Make sure the parts are disinfected properly after each use. If there is pollution
with the parts, please replace with new parts timely. For appropriate methods of
disinfecting, please see the following two instructions:
1) Use a commercially available disinfectant. Please follow the instructions
provided by the disinfectant manufacturer.
A) Disinfectant soaking should be in accordance with the time required in the
instruction manual of disinfectant.
B) Rinse with clean warm water and allow to air dry in a clean environment.
Caution: Never clean with benzene, thinner or flammable chemical.
Rinse the parts with clean hot tap water, and parts may be boiled between
15 to 20 minutes. After boiling, carefully remove the parts, shake off
excess moisture and allow to air dry in a clean environment.
Caution:
Do not boil the air tube, mask, mouthpiece, medication tank, air filter, or
accessories to avoid heat deformation.
After cleaning, all attachments must be dried and then stored in a clean
environment.
Discard any remaining medication in the medication tank.
Please do not left any cleaning fluid residue in the medication tank, and wash
with clean warm water after disinfection.
Always dispose of any remaining medication in the medication tank after each
use. Use fresh medication next time.
Typically, an air filter shall be replaced every three months. If the filter core has
changed color, replace it with a new one.
Air filter Replacement
Caution:
Before use, make sure the air filter is properly installed.
Do not block the air filter.
Use only original air filter designed for this device. Do not operate without a filter.
Do not attempt to wash or clean the filter. If you notice the air filter is wet, please
replace with a new one, otherwise it may cause blockages.
Check that the air filter is clean and free of dust before installation.
Waste and residue Process
The processing of discarded main unit, accessories and other products should be in
accordance with the provisions of the local government.
Notification:
1. For machine damages and failures caused by improper use or failure to follow the
instructions, the company shares no responsibility.
2. When the conditions of temperature, voltage, and product characteristics are not in
line with defined indicators, the main unit may not operate.
3. Product performance may vary with the characteristics of the medication
(suspension or high viscosity).
The company reserves the rights to change the product technology and appearance.
Please don't mind!

~
Type BF applied part
The user must read the
instruction manual
Caution
Do not dispose of in
domestic refuse
Note:IP21 means the limitation degree of protection against
access to hazardous parts with a finger and vertically falling
water drops.
Children are not allowed to use the device in unattended situations.
People who are allergic to injection materials should use the product with caution.
Caution:
Add medicine after the device was closed and prevent spill the medicine to the main unit.
Any operator needs to operate, maintain per the user manual; any question, unexpected
event occurred or unclear description, please contact the carrier or local dealer or the
manufacturer before use.
Personal repair is not allowed.Please contact the supplier if there is any problem with
the product.
For small objects such as filter,be careful not to swallow them by mistake.The power
cord should be placed to avoid tripping or winding.

With the increased number of electronic devices such as PC's and mobile
(cellular) telephones, medical devices in use may be susceptible to
electromagnetic interference from other devices. Electromagnetic interference
may result in incorrect operation of the medical device and create a potentially
unsafe situation.
Medical devices should also not interfere with other devices.
In order to regulate the requirements for EMC (Electro Magnetic Compatibility)
with the aim to prevent unsafe product situations, the EN60601-1-2 standard has
been implemented. This standard defines the levels of immunity to
electromagnetic interferences as well as maximum levels of electromagnetic
emissions for medical devices.
III. EMC instruction
Medical devices manufactured by YUWELL conform to this EN60601-1-2:2014
standard for both immunity and emissions.
Nevertheless, special precautions need to be observed:
The use of accessories and cables other than those specified by YUWELL, with
the exception of cables sold by YUWELL as replacement parts for internal
components, may result in increased emission or decreased immunity of the
device.
The medical devices should not be used adjacent to or stacked with other
equipment. In case adjacent or stacked use is necessary, the medical device
should be observed to verify normal operation in the configuration in which it will
be used.
Refer to further guidance below regarding the EMC environment in which the
device should be used.
Table1 Guidance and manufacturer's declaration electromagnetic emissions
Guidance and manufacturer's declaration – electromagnetic emissions
Device is intended for use in the electromagnetic environment specified below. The
customer or the user of these YUWEII Nebulizers should assure that it is used in such
environment.
The involved model is suitable for use in all
establishments, including domestic
establishments and those directly
connected to the public low-voltage power
supply network that supplies buildings
used for domestic purposes
Voltage fluctuations /
flicker emissions
IEC 61000-3-3
Emissions test Compliance
Complies
Class A
Complies
RF emissions
CISPR14-1
Harmonic emissions
IEC 61000-3-2
Electromagnetic environment - guidance
The involved model
with other equipment.
Guidance and manufacturer's declaration – electromagnetic immunity
Device is intended for use in the electromagnetic environment specified below. The customer
or the user of these YUWEII Nebulizers should assure that it is used in such environment.
Table 2 Guidance and manufacturer's declaration – electromagnetic immunity
Immunity test IEC 60601
Test level
Electrostatic
discharge
IEC 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floor should be wood,
concrete, or ceramic tile. If
floors are covered with
synthetic material, the relative
humidity should be at least
30% RH.
±2 kV for power
supply lines
±1 kV for
input/output lines
±2 kV for power
supply lines
±1 kV for
input/output lines
Mains power quality should be
that of a typical commercial
and/or hospital environment.
Surge
IEC 61000-4-5
±1 kV line to line
±2 kV
line to earth
±1 kV line to line
±2 kV
line to earth
Mains power quality should be
that of a typical commercial
and/or hospital environment.
Voltage dips,
short interruptions
and voltage
variations on
power supply
IEC 61000-4-11
<5 % UT
(>95 % dip in UT)
for 0.5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
<5 % UT
(95 % dip in UT)
for 5 sec.
<5 % UT
(>95 % dip in UT)
for 0.5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
<5 % UT
(95 % dip in UT)
for 5 sec.
Mains power quality should be
that of a typical commercial
and/or hospital environment.
If the user of the nebulizer
involved in this manual
requires continued
interruption, it is
be powered from an
uninterruptible power supply
or battery.
Power frequency
(50/ 60 Hz)
magnetic field
IEC 61000-4-8
3 A/m 3 A/m
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.
Note: UT is the A.C. mains voltage prior to application of the test level.
Electrical fast
transient/burst
IEC 61000-4-4
Compliance level Electromagnetic environment
– guidance
is not suitable for
interconnection
operation
during power mains
recommended
that the involved model
10 11

Table 4 Recommended separation distances
Device is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customers or the users of these YUWELL Nebulizers
can help prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment (transmitters) and The
involved model as recommended below, according to the maximum output
power of the communications equipment.
For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in meters (m) can be estimated using the equation applicable to
the frequency of the transmitter, where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter manufacturer.
Note: At 80MHz and 800MHz, the separation distance for the higher frequency range
applies.
Note: These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects, and people.
Output Power of
Transmitter in
Watt
Separation distance according to frequency
of transmitter in meter
150kHz～80MHz
d=1.2
80MHz～800MHz
d=1.2
800MHz ~ 2.5GHz
d=2.3
P P P
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
Recommended separation distance between portable and mobile RF communications
equipment and the involved model
Immunity test IEC 60601
Test level
Compliance
level
Electromagnetic environment
– guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 V rms
150 kHz ~
80 MHz
3 V/m
80 MHZ to
2.5 GHz
3 V rms
3 V/m
Portable and mobile RF communications
equipment should be used no closer to
any part of the YUWEII nebulizer
including cables, than the
recommended separation distance
calculated from the equation appropriate
to the frequency of the transmitter.
Recommend separation distance
d=1.2
d=1.2 80MHz to 800 MHz
d=2.3 800 MHz to 2.5 GHz
where P is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter
manufacturer and d is the recommended
separation distance in meters (m).
Field strengths from fixed RF
transmitters as determined by an
electromagnetic site survey, a should be
less than the compliance level in each
frequency range. b Interference may
occur in the vicinity of equipment marked
with he following symbol:
Note1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note2: These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects, and people.
a)Field strengths from fixed transmitters, such as base stations for radio (cellular/
cordless) telephones and land mobile radio, AM and FM radio broadcast, and TV
broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which
involvedmodel is
used
exceeds the applicable RF compliance level above, the model should be observed to
verify normal operation. If abnormal performance is observed, additional measures may
be necessary, such as reorienting or relocating the Nebulizer.
b)Over the frequency range 150 kHz to 80MHz, field strengths should be less than 3 V/m.
P
P
P
Guidance and manufacturer's declaration – electromagnetic immunity
Device is intended for use in the electromagnetic environment specified below. The customer
or the user of these YUWEII Nebulizers should assure that it is used in such environment.
Table 3 Guidance and manufacturer's declaration – electromagnetic immunity
Please don't mind!
in this
manual
12 13