4616584-0C_NE-C101-FP_IM_M06_220322.

pdf

General Safety Precautions:

• Inspect the device and parts before using them each time, and check that there are • Subject to technical modification without prior notice.
Intended use Important safety instructions Notes:

Read all the information in the instruction manual and any other literature included in no problems. In particular, be sure to check the following: • This OMRON product is produced under the strict quality system of OMRON
the box before using the device. - That the nozzle or air tube are not damaged. HEALTHCARE Co., Ltd., Japan.
- That the nozzle is not blocked.
Medical Purpose
This product is intended to be used for inhaling medication for respiratory Indicates a potentially hazard ous situation which, if not avoided, could result in • The device may not work if the temperature and voltage conditions are different to
.A. Warning: serious injury. - That the compressor operates normally.
disorders. those defined in the specifications.
• When using this device, there will be some noise and vibration caused by the pump in
The compressor is intended to be multiple patient multiple use. The (Usage)
the compressor. There will also be some noise caused by the emission of compressed • Ensure that this device has acclimated to room temperature before nebulizing the
• For type, dose, and regime of medication follow the instructions of your doctor or medication. Nebulizing the medication after an extreme temperature change could
nebulizer kit and its attachments are single patient multiple use. respiratory therapist. air from the nebulizer kit. This is normal and does not indicate a malfunction.
• Operate the device only as intended. Do not use the device for any other purpose. lead to less nebulization. OMRON recommends waiting for approximately 2 hours
• If you experience any allergic reactions or other difficulties during use, stop using the
• Do not use the device at temperatures greater than +40° C. for the device to warm up or cool down when the device is used at an environment
device immediately and consult your doctor.
• Make sure that the air tube is securely attached to the compressor and nebulizer kit, within the temperature specified as operating conditions after it is stored either at
Intended User
• Legally certified medical experts, such as doctor, nurse and therapist. • Do not use only water in the nebulizer for inhaling purposes.
• Keep the device out of reach of unsupervised infants and children. The device may and does not come loose. Twist the air tube plug slightly when inserting it into the air the maximum or at the minimum storage temperature. For additional information of
• Caregiver or patient under the guidance of qualified medical experts for operating and storage/transport temperature, refer to Technical data.
contain small pieces that can be swallowed. tube connectors to avoid the air tube disconnecting during use.
home treatment. • Do not store the air tube while there is moisture or medication remaining inside. • To completely isolate the device from the power source unplug the plug from the • The device fulfils the provisions of the European Standard EN13544-1:2007 +A1:2009,
• The user should also be capable of understanding general operation of • Do not use or store the device where it may be exposed to noxious fumes or volatile power source. Respiratory therapy equipment - Part1: Nebulizing systems and their componentsand
NE-C101 and the content of instruction manual. substances. • Using the device longer than the standard operating time for which it was designed EN ISO 27427:2019 Anaesthetic and respiratory equipment - Nebulizing systems and
• Do not use the device where it may be exposed to flammable gas. may result in accidents such as fire or injury due to deterioration over time. components.
• Do not cover the compressor with a blanket, towel, or any other type of cover during • Performance may vary with medication such as suspensions or high viscosity. See
use. The compressor could get hot and there is a possible risk of a burn if touched.
medication supplier's data sheet for further details.
Intended Patients Keep these instructions for future reference.
This product should not be used on patients, who are unconscious or are • Always dispose of any remaining medication after use, and use fresh medication each time.
• Do not use in anaesthetic or ventilator breathing circuits. • The particle size distribution and aerosol output may vary by combination of product,
not breathing spontaneously.
• Do not block the ventilation slots. Never place the device where the ventilation slots medication and ambient conditions such as temperature, humidity and atmospheric
may be obstructed during operation. The compressor could get hot and there is a pressure.
Technical data
possible risk of a burn if touched. • The disclosures for nebulizer performance are based upon testing that utilizes adult
Environment
This product is intended for use in a medical facility, such as Hospital, clinic • Store the parts in a clean location to avoid infection. Product Category: Nebulizers
ventilatory patterns and are likely to be different from those stated for paediatric or
and doctor's office, and in a room of general household. (Risk of electrical shock) Product Description: Compressor Nebulizer infant populations.
• Never plug or unplug the device with wet hands. Model: NE-C101 • IP classification is degrees of protection provided by enclosures in accordance with
• The compressor and power cord are not waterproof. Do not spill water or other liquids IEC 60529. The device is protected against solid foreign objects of 12.5mm diameter
Rating: 230V~60Hz
Durable period
Durable periods are as follows, provided the product is used to nebulize on these parts. If liquid does spill on these parts, immediately unplug the power cord and greater such as finger and against vertically falling water drops which may cause
and wipe off the liquid with gauze or other absorbent material. Power Consumption: 150VA issues during a normal operation.
saline 3 times a day for 10 minutes each time at room • Do not immerse the compressor in water or other liquid.
° Current Fuse: T1.6AL250V • Please report to the manufacturer and the competent authority of the Member State
temperature (23 C). • Do not use or store the device in humid locations.
• Do not operate the device with a damaged power cord or plug. in which you are established about any serious incident that has occurred in relation
Compressor Nebulizer Durable period may vary depending on usage environment. Operating Mode: Continuous Use to this device.
• Keep the power cord away from heated surfaces. ° °
Frequent use of the product may shorten the durable period. Operating Temperature/ +5 C to +40 C / 15% to 85%RH (non-condensing)
Model NE-C101 Compressor (Main unit) 5 years
(Cleaning and disinfecting)
Observe the rules below when cleaning or disinfecting parts. Failure to observe these
Humidity/Air Pressure: 700 to 1060hPa
° °
CE 0197
Nebulizer Kil 1 year rules may result in damage, inefficient nebulization or infection. For the instructions, Storage and Transport -20 C to +60 C I 5% to 95%RH (non-condensing)
Instruction Manual refer to "Cleaning and disinfecting" section. Temperature/Humidity:
Mouthpiece 1 year • Clean and disinfect the nebulizer kit, mask, mouthpiece or nosepiece before using
Weight: Approx. 1.05kg (compressor only)
Symbols description
Nosepiece 1 year them when as follows: Need for the user to follow this
Air Tube (PVC)
Air Filter
1 year
60 days
- the first time after purchase
- if the device has not been used for a long period of time
- if more than one person uses the same device
Dimensions: Approx. 145 (W) x 124 (H) x182 (D) mm
(compressor only) e, instruction manual thoroughly
for your safety. t Temperature limitation

Mask (PVC) 1 year

• Be sure to wash or wipe the parts after use, and ensure that they are thoroughly
disinfected and dried, and stored in a clean location.
• Do not leave the cleaning solution to dry on the parts.
Contents: Compressor, Nebulizer Kit, Air Tube (PVC,
100cm), Mouthpiece, Nosepiece, Adult Mask
(PVC), Child Mask (PVC), 2 pcs Spare Air Filters,
O]
Need for the user to consult
the instructions for use
Applied part - Type BF
w Humidity limitation

Instruction Manual, Quick Start Guide. Atmospheric pressure

Precautions for use
Warnings and cautions described in the instruction manual should be mino r or moderate injury, or physical damage. Degree of protection against
B
Indicates a potentially hazardous situation which if not avoided, may result in
4616584-0C [!] limitation
&Caution:
observed. Classification: Class II (Protection against electric shock), electric shock (leakage current)
Issue Date: 2022-03-15
All for Healthcare (Usage)
• In order to prevent strangulation by the power cord or air tube, or injuries caused by Type BF (Applied part); Mouthpiece, Nosepiece,
mishandling, please provide close supervision when this device is being used by, on Class II
Mask, Warranty Card

-t Thank you for purchasing the NE-C101. Know your unit

or near children or invalids.
• Make sure that the parts are attached correctly.
• Make sure that the air filter is correctly attached.
• Make sure that the air filter is clean. If the air filter has been used for more than Type of Medication Liquid:
IP21 (Ingress Protection)

Solution, Suspension
Protection against electric
shock
Ingress protection degree
0 Power OFF

Power ON
t-
60 days, replace it with a new one. IPXX provided by IEC 60529 I
• Do not tilt the nebulizer kit at an angle of greater than 30 degrees in all directions or Particle Size: **MMAD Approx. 3.90µm (2.5%NaF)
This product was developed in conjunction with respiratory therapists
Compressor (Main Unit)* Rear View
for the successful treatment of asthma, chronic bronchitis, allergies shake it while in use. Medication Tank Capacity: 12ml maximum CE Marking Alternating current
and other respiratory disorders. Air Tube
Connector
Power Switch
Power Cord
• Do not use or store the device while the air tube is creased.
• Use only original nebulizing parts, air tube, air filter and air filter cover. Appropriate Medication 2ml minimum - 12ml maximum
CE: ,,.___,,

• Do not add more than 12 ml of medication to the medication tank. Quantities: Serial number Date of manufacture
This is a medical device. Operate the device only as instructed by
your doctor and/or respiratory therapist. Air Filter Cover
Including air filter
• Do not carry or leave the nebulizer kit while the medication tank contains medication.
• Do not leave the device unattended with infants or persons who cannot express their Residual Volume: Approx. 0.7ml
� d
consent. Noise level *Less than 63dB
• Do not subject the device to any strong shocks such as dropping on the floor. Medical Device
Baffle (at 1m distance):

-
How the nebulizer kit works IMDI
• Do not distort the vaporizer head, or jab the nozzle of the medication tank with a pin
The medication that is pumped up or any sharp object. Nebulization Rate: *From 0.3ml/min (by weight loss)
Ae� JL • Do not insert fingers or objects inside the compressor.
-���::.. . � -� Aerosol Output: 0.259ml (2ml, 1 %NaF)
, :; • Do not disassemble or attempt to repair the compressor or power cord.
through the medication channel is
(Waste Electrical & Electronic Equipment)
sol Correct Disposal of This Product
•····· Ventilation Slots • Do not leave the device in extreme hot or cold temperature, or under direct sunlight. Aerosol Output Rate: 0.05ml/min (2ml, 1%NaF)
-M�iicauon Ventilation Slots
mixed with compressed air which is
Nozzle • Do not block the air filter cover. Percentage of Fill Volume 2.5%
generated by a compressor pump. Channel • Do not use the device while sleeping or if drowsy.
Medication Medication • Approved for human use only. Emitted Per Minute:

w
This marking shown on the product or its literature, indicates that it should not be disposed
The compressed air mixed with
I • The compressor may become hot during operation. of, with other household wastes at the end of its working life. To prevent possible harm to the
• Do not touch the compressor for other than necessary operation such as turning off Result of cascade impactor measurements for particle size**
medication is turned into fine particles I
Nebulizer Kit* x 1 Mouthpiece* x 1 Nosepiece* x 1 environment or human health from uncontrolled waste disposal, please separate this product
the power while nebulizing.
from other types of wastes and recycle ii responsibly to promote the sustainable reuse of
and sprayed when in contact with the
• To avoid the medication residue on the face, be sure to wipe the face after removing
Inhalation Top material resources.
the mask.
Cumulative % particle mass of sodium fluoride under size
baffle.
Household users should contact either the retailer where they purchased this product, or
100
t • To avoid injury to the nose mucosa, do not squeeze the nosepiece into the back of
LJ
iR-m
their local government office, for details of where and how they can return this item for
I
the nose.
1-:r
35% ,' environmentally safe recycling.
90
• Do not block the slit between the cap and the inhalation air inlet.
Particle size distribution

Vaporizer Head
Compressed Air -

• Make sure that the vaporizer head is correctly installed before use. 2µm � % � 5µm 47% Business users should contact their supplier and check the terms and conditions of the
�
% >Sµm
, IJ
purchase contract. This product should not be mixed with other commercial waste for disposal.
� 80
• Do not use a damaged nebulizer kit, mouthpiece or nosepiece.
Nozzle
tlJ,
Adult Mask (PVC)* x 1 Child Mask (PVC)* x 1 • While using this device, make sure that no mobile phone or any other electrical ,.,
% <2µm 18%
70
5 devices that emit electromagnetic fields is within 30cm. This may result in
11'-
,, ,,
g- degradation of performance of the device.
a,
.t:!
60
Medication Tank • The nebulizer kit and its attachments are intended for use by a single patient. Do not ,rJ,, a,

--
use by multiple patients; Use separate accessories for each patient.
,, 50
,,,, ---- Individual tes ts
:::,

(Risk of electrical shock)

�
• Always unplug the device from the power outlet after use and before cleaning. -Mean
, , 40
Manufacturer OMRON HEALTHCARE Co., Ltd. Air Tube Connector • Plug the device into the appropriate voltage outlet. Do not overload power outlets or , :
53, Kunotsubo, Terado-cho, Muko, KYOTO, 617-0002 JAPAN
I I

use extension cords.

30
I

/J/ Mass Median Aerodynamic

• Do not misuse the power cord.
,
Diameter (MMAD): 3.9µm
• Do not wind the power cord around the compressor.
20
,,J,, ,
I

Air Tube* Spare Air Filters x 2 Instruction Manual • Changes or modifications not approved by OMRON HEALTHCARE will void the user Geometric Standard Deviation
I

(GSD): 1.9
,
warranty.
10
EU-representative OMRON HEALTHCARE EUROPE B.V. (PVC, 100cm) x 1 -
Scorpius 33, 2132 LR Hoofddorp, THE NETHERLANDS Quick Start Guide • Do not pull the power cord strongly.
I EC IREPI www.omron-healthcare.com Warranty Card 0.1
�,
10 100
0
(Cleaning and disinfecting)
Importer in EU
Observe the rules below when cleaning or disinfecting parts. Failure to observe these Particle Size Dp (µm)
rules may result in damage, inefficient nebulization or infection. For the instructions,
* Measured by OMRON HEALTHCARE Co., Ltd.
Production facility OMRON HEALTHCARE MANUFACTURING VIETNAM CO., LTD.
Binh Duong Province, VIETNAM refer to "Cleaning and disinfecting" section.
• Do not use a microwave oven, dish dryer or hair dryer to dry the device or the parts. ** Measured values reflect internal data obtained by NEXT GENERATION IMPACTOR
• Do not use an autoclave, EOG gas sterilizer or low temperature plasma sterilizer. (NGI), according to EN13544-1:2007 + A1:2009 and ISO27427:2013.
Asia Pacific HQ OMRON HEALTHCARE SINGAPORE PTE LTD.
www.omronhealthcare-ap.com
• When disinfecting parts by boiling, make sure that the container does not boil dry.
• These parts comply with EN ISO 27427:2019 Otherwise it may also result in a fire.
Made in Vietnam

12M3148
-1 1 1 1-