elepho eClear User manual

Full User Manual

2
Foreward
Declaration of conformity
Product type
Important safety information
Technical data
Parts identification
Parts
Display
Installation and operation instructions
Installation parts description
How to install
Notice before use
Using the optional USB power
Using the internal battery
Operating instructions
Troubleshooting
Care and maintenance
Warranty and service
Contents
Disposal
EMC Guidance
1.
2.
3.
4.
5.
6.
6.1
6.2
7.
7. 1
7. 2
7. 3
7. 4
7.5.
7. 6
8.
9.
10.
11.
12.
13 .
3
3
3
4
6
6
6
6
7
7
7
8
9
9
9
12
12
13
13
13
14
Index

3
Thank you for choosing the eClear from Elepho Inc. This product is used to clean a baby’s nose from
mucus which is difficult to extract natually.
This product is for consumer use; it is made up of precise components; please keep it away from
high temperature, humid environments, sunlight and dust. For correctly use, please read this user
manual. Please keep it for future reference as required.
• This product is designed according to the Standard IEC 60601-1: 2012, Medical electrical
equipment Part 1: General requirements for basic safety and essential performance and ANSI/
AAMI ES60601-1:2005/(R) 2012+A1:2012+C1:2009/(R)2012+A2:2010/(R)2012.
• This device has been tested in accordance with IEC 60601-1-2:2014 for EMC. This does not
guarantee in any way that the device will not be affected by electromagnetic interference. Avoid
using the device in high electromagnetic environment.
• The product is classified as Class II ME equipment when it works with an adapter.
• The product is internally powered when it is battery operated.
3.1 - Intended Use
The device which is a portable, hand-held, reusable, battery-powered suction device is intended to
enable an adult to gently suction and clear excessive mucus from the nasal passages of an infant
or child to facilitate easier breathing in a home care environment.
3.2 - Contraindications
Babies or children with the following symptoms should not use this product:
1) Nasal bleeding
2) Coagulopathy (condition of excessive bleeding or clotting or any other bleeding disorder)
3) Cartilage damage or nose injury
4) Acute head, facial or neck injury.
3.3 - Lifespan
The lifespan of the product is 5 years.
1. Foreward
2. Declaration of conformity
3. Product type

4
The warning symbols mentioned in this user manual give guidance of safety and correct method of
use to avoid any harm to your body.
The warning symbols are as follow:
4. Important safety information
Warning symbol Meaning
It may cause harm to body or article.
This product is only suitable for sucking nasal secretions. Please do not use it for other purposes.
Keep the suction nozzle clean and sanitary when in use.
This product should be stored at room temperature, charged to about 40% to 60% of capacity. In case of
over-discharge, pack should be charged for one time every 3 months while storing and batteries should be
discharge and charge after being stored more than a year in order to activate it and restore energy.
Please keep the nasal aspirator away from the sun or high temperature and humidity, and keep it in a
clean, dry place with a temperature of 41˚F - 113˚F (5˚C - 45˚C) and a humidity of less than 85%.
Please store this product in the ambient temperature range of -4˚F - 131˚F (-20˚C - 55˚C). When the
equipment is transferred from the lowest storage ambient temperature to the ambient temperature of 68˚F
(20˚C), it takes 40 minutes to return to normal operation. It takes 40 minutes to return to normal operation
from the highest storage ambient temperature to 68˚F (20˚C).
This device compiles with Part 15 of FCC
(Federal Communications Commission)
Rules.
The device and accessories and the
packaging have to be disposed of
waste correctly at the end of usage.
Please follow local ordinances or
regulations for disposal.
This symbol means type BF applied
part. Batch code
This symbol means the appliance is
Class II equipment. Restriction of Hazardous Substances.
Read the user manual carefully before
using this device. Recyclable
Date of manufacture Manufacturer
IP22: The first number 2: Protected
against solid foreign objects of Ф12.5
mm and greater. The second number 2:
Protected against vertically falling water
drops when enclosure titled up to 15º.
SN Serial number
Product conforms with European health,
safety, and environmental protection
standards.

5
During storage, please pay attention to the influence of dirt, dust, light (including sunlight); regularly use a
damp rag to wipe the external surface of the product, and avoid direct sunlight during storage.
During storage, please keep the product away from pets and children to avoid damaging the product or
swallowing. Please pay attention to prevent the contamination of this product by pests.
Please don’t service or maintain any parts of the Nasal Aspirator while in use.
If you find any problem, please stop using and contact customer service. Self-repair is prohibited.
When the product cannot be used or discarded, please follow the local regulations to deal with it and avoid
environmental pollution.
The nasal aspirator can only use the special accessories provided by the manufacturer and can only be connected
to the equipment that does not have external voltage risk and conforms to IEC 60601-1 safety standards.
In order to prevent the water drop from sucking into the pump body and affecting the product performance,
it is forbidden to clean the electrode and the air inlet of the nearby pump body when the product is
operated
When using this product, please keep your mouth open, do not hold your breath or swallow saliva, so as to
avoid unbalanced ear pressure.
It is strictly forbidden to clean or soak the body parts under the nasal aspirator collection container. Please
don't immerse it in water or other liquid, and don't flush it to the tap.
Do not drop, disassemble, repair or transform the product.
Keep away from strong electrostatic field or strong magnetic field, so as not to affect the product
performance and normal use.
Microwave disinfection and autoclave disinfection are prohibited.
Please read this manual carefully before use. Incorrect use of this product may cause the following symptoms:
a. Nasal allergy
b. Bleeding of nasal mucosa
Please keep the nasal aspirator out of the reach of children under 12 years old. Especially care of inhalation
or swallowing of small parts or accessories.
Do not put the nasal aspirator into the fire.
Middle and high gears are NOT recommended for newborns.
Do not charge the lithium battery for more than 12 hours otherwise the lithium battery may be damaged or
even cause danger.
Do not use USB power supply with external voltage risk that does not conform to IEC 60601-1 safety
standards.
Contraindications:
1) Nose bleeding.
2) Coagulation or hemorrhagic disease.
3) Nose Injured to cartilage or flesh.
Caution: This unit has been thoroughly tested and inspected to assure proper performance
and operation.

6
5. Technical Data
6. Parts identification
6.1 Parts
6.2 Display
Name Nasal Aspirator (eClear)
Model HTD2601US
Display LED
Operating conditions
Ambient temperature: 41˚F - 113˚F (5˚C - 45˚C)
Relative humidity (RH): ≤85%
Atmospheric pressure: 700 hPa-1060 hPa
Transport and storage
conditions
Ambient temperature: -4˚F - 131˚F (-20˚C - 55˚C)
Relative humidity (RH): ≤93%
Atmospheric pressure: 700 hPa-1060 hPa
Product weight: 5.9oz (167g)
Suction range: ≤ 65kpa
Automatic Power-off ≤ 65 s
Internal power supply Lithium Polymer Battery: DC 3.7V
USB Power Source Input: DC 5V, ≥1A
1. Suction nozzle
2. Transparent cover
3. Collecting cup base
4. Display screen
5. Power button
6. Plastic shell
7. USB charging interface
8. Induction electrode
9. Collecting cup
10. Air inlet of pump body
1. Cleaning prompt
2. Battery capacity indicator
3. Suction level indicator
1
2
3
4
5
6
1
3
7
810
2
9

7
7. Installation and operation instructions
7.1 Installation parts description
7.2 How to install
Suction nozzle
(thick, to clean deep nasal cavity) Transparent cover
Suction nozzle
(thin, to clean nostril ) Collecting cup
Seal ring Silica gel cover
7.2.1 - Before installation, please check whether the product appearance is good and complete.
If there is any defect, please contact the supplier or manufacturer.
7.2.2 - Component installation:
a. Align the hole position of silica gel cover with the locating column on the cup, cover on
the collecting cup, and gently press around the silica gel cover to ensure it is installed in
place.
b. Install the collecting cup with the
locating column and aligne with the
gap of the cup base onto the body.
Locating

8
d. Install the suction nozzle on the
transparent cover.
Note: during installation, fingers should
be kept away from the tip of the suction
nozzle to avoid bacteria pollution.
7.3 Notice before use
a. If the baby’s nose is dry, it should be carefully humidified:
Apply a warm towel on both sides of the baby's nose for about 10 minutes. When the nasal
mucosa contracts with heat, the nasal cavity becomes smooth, and the viscous nasal mucus
will also be hydrated and more easily absorbed. Alternatively gently wet the inner dry area
of the baby's nose with a cotton swab dipped in warm saline / sesame oil for about a few
minutes, and then use the aspirator to suck out the mucus. Do NOT use excessive force or
hard pulling while extracting a ‘booger’ from the baby's dry nose.
b. Cleaning and disinfection. Before use, ensure that the suction nozzle is cleaned and sanitized.
c. Before use, please check whether the suction at the suction nozzle is good - If there is air
leakage, please check whether the transparent cover is in place, and whether the sealing ring
at the bottom of the transparent cover is installed correctly in place with the transparent cover.
d. On young babies it is not recommended to use the middle and high gear of suction to
avoid any discomfort or potential damage to sensitive parts of the inner nose area.
c. Screw the transparent cover on the body.

9
Put the USB plug connected to DC 5V power supply
into the USB socket at the bottom of the device.
After power is turned on, the unit is powered by the internal lithium battery without the use of the
USB cable. When fully charged, it can be used for approximately 100 times for one minute each
usage. The Lithium battery can charge and discharge for approximately 500 times during the life
of the rechargeable battery.
7.6.1 - Start up
a. In standby mode, press the power button to turn
the eClear on at which point all symbols will be
briefly displayed on the screen. By default level
one operation will be selected.
b. Press the button (once) to move to different (higher)
suction strengths (between I, II and III).
c. To turn off the device keep the button pressed and
the device will automatically turn off.
d. In the charging mode by pressing the power
button the device will automatically cut off the
charging mode and switch to the working mode of
(first suction gear) operation.
The battery power is not displayed at this time.
After use, the nasal aspirator will return to the
charging mode if connected to the charger.
Notes:
1. Please choose an adapter that meets the IEC
60601-1-2 standard.
2. When the lithium battery power is low, you can
connect the USB cable with DC 5V input and
continue to use the nasal aspirator. While in use,
the nasal aspirator will disconnect the charging
of the battery. When the nasal aspirator is turned
off it will switch back to the charging mode if still
connected to the charger.
7.4 Using the Optional USB power
7.5 Using the internal battery
7.6 Operating instructions
USB

10
Notes:
1. The suction nozzle should be in full contact
with the mucus, and the angle between
the suction nozzle and the nostril should be
about 20-30 degrees;
2. During use please make sure the baby's
mouth is open to avoid negative pressure
entering the ear cavity.
3. When using, it is recommended that the baby sit up, or half lie down and raise baby’s head.
Please do not move baby’s head while using the aspirator to avoid damage to the nasal cavity.
4. When the liquid is about to enter the gap between the transparent cover and the side wall of
the collecting cup, it is recommended to clean the collecting cup and the transparent cover
in advance. If the liquid enters the side wall gap and triggers the electrode to enter the alarm
mode, the electrode and its surrounding must be cleaned.
5. When the cleaning prompt is displayed please dismantle the collection cup and clean it. If the
cleaning prompt continues to flash it means the unit needs to be further dried before use. " "
Make sure the
mouth is open
7.6.4 - Shut down
Automatic shutdown
When the nasal aspirator is not active for more than 65 seconds it will automatically shut down.
7.6.2 - Aspirating the mucus
Please keep the product display screen facing up and gently insert the suction nozzle into the nose
for suction.

11
7.6.5. - Cleaning
It is recommended to clean the unit and the collection cup after each use to prevent any build-up of
bacteria over time. During cleaning process do not use or connect the device to the power supply.
a. Cleaning of suction nozzle, transparent cover and collecting cup - Remove the transparent cover
and collecting cup from the host machine, and then remove the suction nozzle when cleaning
the transparent cover. It is recommended to clean it with clear water (neutral solvent can be used
if necessary). After cleaning, fully dry it and store it in a dry and clean place.
Note: Please make sure that the transparent cover, collecting cup and silica gel cover have been
dried without any residual water to avoid the drops triggering the cleaning alarm and shutdown
b. Cleaning of the body surface
Please use a damp cloth to clean the shell of the body. If the electrode on the upper part of the
machine body has touched the liquid, please wipe it with a towel or soft cloth until the indicator
light " " no longer flashes. If the flashing continued it means the electrode is not completely
dry.
Note: it is forbidden to immerse the body in water or wash it under a faucet to avoid the water
flow into the air inlet of the pump body. THIS WILL VOID THE PRODUCT WARRENTY.

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8. Troubleshooting
9. Care and Maintenance
9.1. Product maintenance and storage
1. Every time the nasal aspirator is used, it should be cleaned. Before use, it should also be
disinfected to avoid infection.
2. If the nasal aspirator is not used for a long time please fully charge the battery before use.
3. It is recommended to charge the device at least once every 3-6 months To maintain battery life/
charging capacity.
4. Carefully protect the surface of the display from damage.
5. Place the nasal aspirator in a dry place to avoid dust, household dirt and direct sunlight.
9.2. Storage and transportation conditions
1. Ambient temperature: -4˚F - 131˚F (-20˚C - 55˚C)
2. Relative humidity: 10% - 93%
Problem Possible Cause Proposed Solution
No display when you press the power
button
The battery may have been
depleted if not used for a
long time
Please use USB power supply
to recharge the lithium battery
before using.
Cannot suck out the mucus.
Mucus is dry.
Humidify the dry mucus with
saline or equivalent and try again
a few minutes later.
Wrong angle of use. Try to adjust the angle during the
process of suction.
Liquid overfill
The liquid has overfilled from
the collecting cup.
Turn off the unit and open the
transparent cover, clean the
collecting cup and use after all
components are completely dry.
The first segment of the battery
capacity indicator keeps flashing
Low battery.
Connect the USB cable to a
charging device. Then connect
the micro-USB end of the cable to
nasal aspirator.

13
WARNING:
1. Do not modify this equipment without authorization from manufacturer.
2. The device cannot be dismantled by the operators. If you need reassembly, please contact
the manufacturer.
• 2 pieces of silica gel suction nozzles
• 2 pieces of silica gel sealing rings (1 large and 1 small)
• 1 USB power cable
• 1 Full User Guide
• 1 Quick User Guide
10. Warranty and service
11. Contents
The warranty period is 1 year after time of purchase.
Note: if the product is disassembled the warranty is void.
Please keep the sales receipt as evidence of when/where the device was purchased.
Manufactured for Elepho Inc by Hetaida Technology Co., Ltd.
Dongguan City, Guangdong Province, P.R. China
Manufactured
WARNING:
The use of accessories NOT supplied with the purchase of the device is forbidden and will void
the warranty.
12. Disposal
At the end of the product life, the device should not be disposed of in household garbage. It should
be disposed of in accordance with local regulations and laws relating to the disposal of battery
operated products

14
13. EMC Guidance
Warning: Don’t use near active HF surgical equipment and the RF shielded room of an ME system
for magnetic resonance imaging, where the intensity of EM disturbances is high.
Warning: Use of this equipment adjacent to or stacked with other equipment should be avoided
because it could result in improper operation. If such use is necessary, this equipment and the other
equipment should be observed to verify that they are operating normally.
Warning: Use of accessories, transducers, and cables other than those specified or provided by the
manufacturer of this equipment could result in increased electromagnetic emissions or decreased
electromagnetic immunity of this equipment and result in improper operation.
Warning: Portable RF communications equipment (including peripherals such as antenna cables
and external antennas) should be used no closer than 12 in (30 cm) to any part of the equipment,
including cables specified by the manufacturer. Otherwise, degradation of the performance of this
equipment could result.
Guidance and Manufacturer’s Declaration – Electromagnetic Emissions
Emissions test Compliance
RF emissions CISPR 11 Group 1
RF emissions CISPR 11 Class B
Harmonic emissions IEC 61000-3-2 Class A
Voltage fluctuations/ flicker emissions IEC 61000-3-3 Complies
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
Immunity Test IEC 60601-1-2 Test level Compliance level
Electrostatic discharge (ESD) IEC
61000-4-2
±8 kV contact
±2 kV, ±4kV, ±8 kV, ±15 kV air
±8 kV contact
±2 kV, ±4kV, ±8 kV, ±15 kV air
Electrical fast transient/burst IEC
61000-4-4
±2 kV for power supply lines
±1 kV for input/output lines
±2 kV for power supply lines
±1 kV for input/output lines
Surge IEC61000-4-5 ± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
Voltage dips, short interruptions
and voltage variations on power
supply input lines IEC
61000-4-11
0 % UT; 0.5 cycle at 0˚,45˚,90˚,
135˚, 180˚, 225˚, 270˚, 315˚,
0 % UT ; 1 cycle 70 % UT; 25/30
cycle
0% UT; 250/300 cycle
0 % UT; 0.5 cycle at 0˚,45˚,90˚,
135˚, 180˚, 225˚, 270˚, 315˚,
0 % UT ; 1 cycle, 70 % UT;
25/30 cycle
0% UT; 250/300 cycle
Power frequency magnetic field
IEC 61000-4-8
30 A/m
50Hz/60Hz
30 A/m
50Hz/60Hz
Conduced RF IEC61000-4-6
3 V r.m.s.
150 kHz to 80 MHz
6 V RMS in the ISM and amateur
bands between 0.15 MHz and 80
MHz
3 V r.m.s.
150 kHz to 80 MHz
6 V RMS in the ISM and amateur
bands between 0.15 MHz and 80
MHz
Radiated RF IEC61000-4-3
10 V/m
80 MHz – 2,7 GHz
80 % AM at 1 kHz
10 V/m
80 MHz – 2,7 GHz
80 % AM at 1 kHz
NOTE UT is the a.c. mains voltage prior to application of the test level.

15
Warranty
The warranty period for device is one year from date of delivery. In case of a warranty claim,
the date of delivery has to be proven by means of the sales receipt or invoice.
Repairs under warranty do not extend after the warranty period.
The following cases are excluded under the warranty:
• All damage due to improper treatment, e.g. failure to follow the user guide.
• All damage due to repair or tampering by the customer or unauthorized third parties.
• Damage incurred during transport from the manufacturer to the consumer or during
transport to the service center.
• Accessories that are subject to normal wear and tear.
• Battery module is not covered under the warranty.
Liability for direct or indirect consequential losses caused by the unit is excluded even if the
damage to the unit is accepted as a warranty claim.
Contact your point of sales representatives and include your product purchase receipt as
evidence for service support during the warranty period.

Made in China
Hetaida Technology Company, Ltd,
Guangdong Province, P.R. China.
Manufactured for:
Elepho Inc., 466 Central Ave (2nd floor), Cedarhurst, New York 11516, USA
Item/Device #: HTD2601US
Product/model name: eClear
Telephone support via Elepho Consumer Relations at: 1-833-435-3746 (1-833-4-ELEPHO)
General information regarding Elepho full product line: www.elepho.com
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