Instruction Manual: Compressor Nebulizer Model

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NE-C900-E_C_M02_130319.

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General Safety Precautions:


Important safety instructions • Inspect the device and parts before using them each time, and check that there are
Read all the information in the instruction manual and any other literature included in no problems. In particular, be sure to check the following:
Thank you for purchasing the OMRON COMP AIR Pro. - That the nozzle or air tube are not damaged.
the box before using the device.
This product was developed in conjunction with respiratory therapists Indicates a potentially hazardous situation which, if not avoided, could result in
- That the nozzle is not blocked.
for the successful treatment of asthma, chronic bronchitis, allergies Warning: serious injury. - That the compressor operates normally.
• When using this device, there will be some noise and vibration caused by the pump in
and other respiratory disorders. (Usage) the compressor. There will also be some noise caused by the emission of compressed
• For type, dose, and regime of medication follow the instructions of your doctor or air from the nebulizer kit. This is normal and does not indicate a malfunction.
This is a medical device. Operate the device only as instructed by respiratory therapist. • Operate the device only as intended. Do not use the device for any other purpose.
your doctor and/or respiratory therapist. • If you feel anything unusual during use, stop using the device immediately and • Do not use the device at temperatures greater than +40°C.
consult your doctor. • Make sure that the air tube is securely attached to the compressor and nebulizer kit,
• Do not use only water in the nebulizer for inhaling purposes. and does not come loose. Twist the air tube plug slightly when inserting it into the air
How the nebulizer kit works Baffle • Keep the device out of the reach of unsupervised infants and children. The device tube connectors to avoid the air tube disconnecting during use.
Aerosol Aerosol may contain small pieces that can be swallowed. • To completely isolate the device from the power source unplug the plug from the
The medication that is pumped up • Do not store the air tube while there is moisture or medication remaining inside. power source.
through the medication channel is • Do not use or store the device where it may be exposed to noxious fumes or volatile
Keep these instructions for future reference.
mixed with compressed air which is Medication substances.
Nozzle Channel • Do not use the device where it may be exposed to flammable gas.
generated by a compressor pump. Medication Medication • Do not cover the compressor with a blanket, towel, or any other type of cover during
The compressed air mixed with use.
• Always dispose of any remaining medication after use, and use fresh medication each
medication is turned into fine particles time.
and sprayed when in contact with the • Do not use in anaesthetic or ventilator breathing circuits.
baffle. • Do not block the ventilation slots. Never place the device where the ventilation slots
may be obstructed during operation.
• Store the parts in a clean location for avoiding infection. Important information regarding Electro Magnetic Compatibility (EMC)
Compressed Air (Risk of electrical shock) With the increased number of electronic devices such as PC’s and mobile (cellular)
• Never plug or unplug the device with wet hands. telephones, medical devices in use may be susceptible to electromagnetic interference
TM
Manufacturer OMRON HEALTHCARE Co., Ltd. • The compressor and power cord are not waterproof. Do not spill water or other liquids from other devices. Electromagnetic interference may result in incorrect operation of the
53, Kunotsubo, Terado-cho, Muko, Kyoto, 617-0002 JAPAN on these parts. If liquid does spill on these parts, immediately unplug the power cord medical device and create a potentially unsafe situation.
and wipe off the liquid with gauze or other absorbent material. Medical devices should also not interfere with other devices.
Compressor Nebulizer • Do not immerse the compressor in water or other liquid. In order to regulate the requirements for EMC (Electro Magnetic Compatibility) with
• Do not use or store the device in humid locations.
Model NE-C900
the aim to prevent unsafe product situations, the EN60601-1-2:2007 standard has
EU-representative OMRON HEALTHCARE EUROPE B.V. • Do not operate the device with a damaged power cord or plug. been implemented. This standard defines the levels of immunity to electromagnetic
Scorpius 33, 2132 LR Hoofddorp, THE NETHERLANDS • Keep the power cord away from heated surfaces. interferences as well as maximum levels of electromagnetic emissions for medical
www.omron-healthcare.com (Cleaning and disinfecting) devices.
Observe the rules below when cleaning or disinfecting parts. Failure to observe these This medical device manufactured by OMRON HEALTHCARE conforms to this
Instruction Manual Production facility
OMRON (DALIAN) CO., LTD.
Dalian, CHINA
rules may result in damage, inefficient nebulization or infection. For the instructions,
refer to “Cleaning and disinfecting” section.
EN60601-1-2:2007 standard for both immunity and emissions.
Nevertheless, special precautions need to be observed:
• Clean and disinfect the nebulizer kit, mask, mouthpiece or nosepiece before using • Do not use mobile (cellular) telephones and other devices, which generate strong
OMRON HEALTHCARE UK LTD. them when as follows: electrical or electromagnetic fields, near the medical device. This may result in
Subsidiary
EN Opal Drive, Fox Milne, Milton Keynes, MK15 0DG, U.K. - the first time after purchase. incorrect operation of the unit and create a potentially unsafe situation.
- if the device has not been used for a long period of time Recommendation is to keep a minimum distance of 7 m. Verify correct operation of
Made in China
- if more than one person uses the same device the device in case the distance is shorter.
• Be sure to wash or wipe the parts after use, and ensure that they are thoroughly Further documentation in accordance with EN60601-1-2:2007 is available at OMRON
disinfected and dried, and stored in a clean location. HEALTHCARE EUROPE at the address mentioned in this instruction manual.
IM-NE-C900-UK-EN-03-03/2013 • Do not leave the cleaning solution in the parts.
1675434-4B Documentation is also available at www.omron-healthcare.com.
Indicates a potentially hazardous situation which if not avoided, may result in
Caution: minor or moderate injury, or physical damage.
(Usage)
Intended use Know your unit • Provide close supervision when this device is used by, on, or near children or invalids. Correct Disposal of This Product
• Make sure that the parts are attached correctly. (Waste Electrical & Electronic Equipment)
• Make sure that the air filter is correctly attached.
Medical Purpose Rear View
• Make sure that the air filter is clean. If the air filter has been used for more than 60
Power Cord
This product is intended to be used for inhaling medication for respiratory days, replace it with a new one.
disorders. Compressor (Main Unit) x 1 • Do not tilt the nebulizer kit at an angle of greater than 45 degrees in all directions or This marking shown on the product or its literature, indicates that it should not be
shake it while in use. disposed of, with other household wastes at the end of its working life. To prevent
Intended User • Do not use or store the device while the air tube is creased. possible harm to the environment or human health from uncontrolled waste disposal,
Nebulizer Kit Holder • Use only original nebulizing parts, air tube, air filter and air filter cover. please separate this product from other types of wastes and recycle it responsibly to
• Legally certified medical experts, such as doctor, nurse and therapist. • Do not add more than 7 ml of medication to the medication tank. promote the sustainable reuse of material resources.
• Caregiver or patient under the guidance of qualified medical experts for • Do not carry or leave the nebulizer kit while the medication tank contains medication. Household users should contact either the retailer where they purchased this product,
home treatment. Ventilation Slots • Do not leave the device unattended with infants or persons who cannot express their or their local government office, for details of where and how they can return this item
consent. for environmentally safe recycling.
• The user should also be capable of understanding general operation of Power Plug Business users should contact their supplier and check the terms and conditions of the
• Do not subject the device or the parts to any strong shocks such as dropping the device
NE-C900 and the content of instruction manual. purchase contract. This product should not be mixed with other commercial wastes for
on the floor.
disposal.
• Do not jab the nozzle of the medication tank with a pin or any sharp object.
Intended Patients • Do not insert fingers or objects inside the compressor.
This product should not be used on patients, who are unconscious or are • Do not disassemble or attempt to repair the compressor or power cord.
not breathing spontaneously. • Do not leave the device or its parts in extreme hot or cold temperature, or under direct
sunlight.
Ventilation Slots
Environment Air Tube
• Do not block the air filter cover. Accessories
This product is intended for use in a medical facility, such as Hospital, Power Switch • Do not use the device while sleeping or if drowsy.
Connector Air Filter Cover • Approved for human use only.
clinic and doctor’s office, and in a room of general household. *Air filter inside • When using the device, the main unit may become hot. Name Model Order No.
• Do not touch the main unit for other than necessary operation such as turning off the
Durable period Nebulizer Kit x 1 Mouthpiece x 1 Nosepiece x 1 power while nebulizing. Nebulizer Kit & Mouthpiece Set NEB-NSET3-90E 9520555-5
Durable periods are as follows, provided the product is used to nebulize • To avoid the medication residue on the face, be sure to wipe the face after removing
the mask. Adult Mask (PVC) C28-8-E 9956275-1
2 ml of medication 10 times a day for 6 minutes each time at room
temperature (23°C). • To avoid injury to the nose mucosa, do not squeeze the nosepiece into the back of Child Mask (PVC) C28-9-E 9956276-0
Inhalation Top the nose.
Durable period may vary depending on usage environment. • Do not use a damaged nebulizer kit, mouthpiece or nosepiece. Infant Mask (PVC) NEB-MSSP-E 9520250-5
Compressor (Main unit) 5 years (Risk of electrical shock)
Adult Mask (SEBS) U10-1P-E 9956312-0
Nebulizer Kit 1 year Adult Mask (PVC) x 1 Child Mask (PVC) x 1 • Always unplug the device from the power outlet after use and before cleaning.
Mouthpiece 1 year Medication Tank • Plug the device into the appropriate voltage outlet. Do not overload power outlets or Child Mask (SEBS) Set U10-2P-E 9956281-6
use extension cords.
Nosepiece 1 year • Do not misuse the power cord. Mouthpiece C28-3P-E 9956273-5
Air Tube (PVC, 200cm) 1 year • Do not wind the power cord around the compressor.
• Changes or modifications not approved by OMRON HEALTHCARE will void the Nosepiece C28-7-E 9956274-3
Air Filter 60 days
user warranty.
Mask (PVC)/(SEBS) 1 year • Do not pull the power cord strongly. Air Tube (PVC, 200cm) NEB-TP-L20E 9520606-3
Air Tube
(PVC, 200cm) x 1 (Cleaning and disinfecting) Air Filters x 5 C28-2-E 9956271-9
Precautions for use Observe the rules below when cleaning or disinfecting parts. Failure to observe these
Warnings and cautions described in the instruction manual should be Spare Air Filters x 5 Instruction Manual rules may result in damage, inefficient nebulization or infection. For the instructions,
observed. Warranty card
refer to “Cleaning and disinfecting” section.
• Do not use a microwave oven, dish dryer or hair dryer to dry the device or the parts.
• Do not use an autoclave, EOG gas sterilizer or low temperature plasma sterilizer.
• When disinfecting parts by boiling, make sure that the container does not boil dry.
Otherwise it may also result in fire.

13C0728
How to use Cleaning and disinfecting Removing condensation from the air tube Technical data
If there is moisture or liquid remaining in the air tube, be sure to follow the Name: COMP AIR Pro
Warning: Cleaning procedure below to remove any moisture from within the air tube.
Clean and disinfect the nebulizer kit, mask, mouthpiece or nosepiece before using them Model: NE-C900 (NE-C900-UK)
when as follows: Clean the parts after each use to remove residual medication. This will avoid 1) Make sure that the air tube is connected to the air connector on the
inefficient nebulization or infection. Type: Compressor Nebulizer
- the first time after purchase. compressor.
- if the device has not been used for a long period of time Rating: AC 220-240V, 50Hz
■ Washable parts 2) Remove the air tube from the nebulizer kit.
- if more than one person uses the same device Power Consumption: 220VA
For the instructions, refer to “Cleaning and disinfecting” section. 3) Turn on the compressor and pump air through the air tube to expel the
• Nebulizer Kit (Inhalation top, Medication tank), Mask (PVC)/(SEBS),
moisture. Operating Temperature/ +10°C to +40°C / 30% to 85%RH
Mouthpiece, Nosepiece
1. Make sure that the power switch is in the off ( ) position. Humidity:
Wash them in warm water and mild detergent (neutral detergent). Rinse
2. Plug the power plug into a power outlet. them thoroughly with clean hot tap water and allow to air dry in a clean Storage and Transport -20°C to +60°C / 10% to 95%RH /
Changing the air filter Temperature/Humidity/ 700 - 1060hPa
2 place.
3. Remove the inhalation top from the medication If the air filter has been used for more than 60 days, replace it with a new Air Pressure:
tank. ■ Non-washable parts one. Weight: Approx. 2.2kg (compressor only)
1 • Compressor, Air Tube
1. Pull the air filter cover off the compressor. Dimensions: Approx. 175 (W) × 110 (H) ×215 (D) mm
Firstly, make sure that the power plug is unplugged from the power outlet. (compressor only)
Wipe clean with a soft cloth moistened with water or mild detergent Contents: Compressor, Nebulizer Kit, Air Tube (PVC,
4. Add the correct amount of prescribed medication (neutral detergent). 200cm), Mouthpiece, Nosepiece, Adult Mask
to the medication tank. • Air Filter (PVC), Child Mask (PVC), 5 pcs Spare Air
Do not wash or clean the air filter. If the air filter becomes wet, replace it. Filters, Instruction Manual, Warranty Card.
Damp air filters can cause blockages. Classification: Class ll equipment, Type B applied part
2. Change the air filter.
Disinfecting Remove the old air filter with a sharp object = Class ll = Type B Read the instruction
and insert the new air filter. equipment applied part manual carefully
5. Put the inhalation top back inside the medication Always disinfect the parts after the last treatment of the day. If the parts are
tank. heavily stained, replace them with new ones.
3. Put the air filter cover back in place. = Power off = Power on
Clicks Make sure it is attached properly.
To select a method for disinfection, refer to the table below.
Notes: Technical data for the OMRON NE-C900 Compressor with the Nebulizer Kit:
1 o: applicable X: not applicable • Use only OMRON air filters designed for this device. Do not operate without a filter. Particle Size: **MMAD Approx. 3µm
• Do not wash or clean the filter. If the air filter becomes wet, replace it. Damp air filters MMAD = Mass Median Aerodynamic Diameter
2 can cause blockages.

Adult Mask (SEBS)

Child Mask (SEBS)

Infant Mask (PVC)


Medication Tank Capacity: 7ml maximum

Adult Mask (PVC)


Child Mask (PVC)
• There is no front or back orientation for the air filters.

(PVC, 200cm)
• Check that air filters are clean and free of dust before inserting them. Appropriate Medication 2ml minimum - 7ml maximum

Nebulizer Kit
Parts

Mouthpiece

Nosepiece
6. Attach the mask, mouthpiece or nosepiece to the nebulizer kit tightly. Quantities:

(optional)

(optional)

(optional)

Air Tube

Air Filter
Sound: *Approx. 55dB
Disinfecting
method Nebulization Rate: *Approx. 0.4ml/min (by weight loss)
Airflow/Compressor *7L/min @100kPa

(Phthalate free)

(Phthalate free)
Band: Rubber

Band: Rubber
Mask: SEBS

Adapter: PP

Mask: PVC
(non-latex)

(non-latex)
Output:

Polyester
PVC
PP

PP

PP
Materials Aerosol Output: **0.57ml (2ml, 1%NaF)
Aerosol Output Rate: **0.08ml/min (2ml, 1%NaF)
Troubleshooting
Alcohol Result of cascade impactor measurements for particle size**

Disinfecting
o o o o o X X Check the following if your unit should fail during operation.
ethanol Problem Cause Remedy Cumulative % particle mass of sodium fluoride under size
7. Attach the air tube.
Sodium Nothing happens when the Is the power plug plugged into Check that the plug is inserted
Twist the air tube plug slightly and push it firmly into the air tube connector. power switch is pressed. a power outlet? in a power outlet. Unplug then 100
hypochlorite
Milton*
o o o o o X X reinsert the plug if necessary.
90
(0.1%, 15min.)

Cumulative Undersize%
80
No nebulization or low Is there medication in the Add the correct amount of
Quaternary nebulization rate, when the medication tank? medication to the medication tank. 70
ammonium power is on.
A
Osvan*
o o o o o X X Is there too much/little
60

(0.1%, 10min.) medication in the medication 50


tank?
40
Chlorhexidine
Is the nebulizer kit assembled Assemble the nebulizer kit

Hibitane*
o o o o o X X correctly? correctly.
Mean
30
20
(0.5%, 30min.) Individual tests
Is the nozzle blocked? Make sure that the nozzle is free 10
Amphoteric of blockages.
Surfactant 0

Tego 51*
o o o o o X X Is the nebulizer kit tilted at a Make sure that the nebulizer kit is 0.1 1 10 100
8. Hold the nebulizer kit as (0.2%, 15min.)
sharp angle? not tilted at an angle of more than Particle Size Dp (μm)
45 degrees.
indicated on the right. * Measured by OMRON HEALTHCARE Co., Ltd.
Follow the instructions of B Boiling o o o o X X X Is the air tube connected Make sure that the air tube
** Independently measured by Prof. Dr. Hiroshi Takano, Department of Chemical
correctly? is correctly connected to the Engineering and Materials Science, Faculty of Science and Engineering, Doshisha
your doctor or respiratory * an example of commercially available disinfectant. (The concentration and residence compressor and nebulizer kit. University, Kyoto, Japan, according to EN 13544-1:2007+A1:2009.
therapist. time specified in the table are under the conditions where the service life of the parts
is tested with each disinfectant used as described in its instruction manual. Please Notes:
Is the air tube folded or Make sure that the air tube does
note that the testing was not performed for the purpose of ensuring the effectiveness
of the disinfectants. There is no intention of suggesting that such disinfectants be
damaged? not contain kinks. • Subject to technical modification without prior notice.
used. Conditions of use and ingredients of disinfectant vary for manufacturers. • This OMRON product is produced under the strict quality system of OMRON
Is the air tube blocked? Make sure that the air tube is free
Please read the instruction manuals carefully before use and apply disinfectant to HEALTHCARE Co., Ltd., Japan.
each part in an appropriate way. Please notice that service life of the parts may be of blockages.
Right angle shorter depending on conditions, environments and frequency of use.)
• The device may not work if the temperature and voltage conditions are different to
Caution: those defined in the specifications.
Is the air filter dirty? Replace the air filter with a new
Do not tilt the nebulizer kit at an 45° 45° A. Use a commercially available disinfectant. Follow the instructions one. • This device fulfils the provisions of the EC directive 93/42/EEC (Medical Device
angle of greater than 45 degrees Directive) and the European Standard EN13544-1:2007+A1:2009, Respiratory
in all directions. Medication may
provided by the disinfectant manufacturer. The device is abnormally Is the air filter cover attached Attach the air filter cover correctly. therapy equipment - Part1: Nebulizing systems and their components.
flow into the mouth or it may result loud. correctly?
Note: Never clean with benzene, thinner or a flammable chemical. • Performance may vary with drugs such as suspensions or high viscosity. See drug
in not nebulizing effectively. The device is very hot. Is the compressor covered? Do not cover the compressor with supplier’s data sheet for further details.
B. Parts may be boiled between 15 to 20 minutes. any type of cover during use. • See website of OMRON HEALTHCARE EUROPE to update technical information.
URL: www.omron-healthcare.com
9. Press the power switch to the on ( ) position. As the compressor After boiling, carefully remove the parts, shake Note: If the suggested remedy does not solve the problem, do not try to repair the device
starts, nebulization begins and aerosol is generated. off excess water and allow to air dry in a clean - no parts of the unit are user serviceable. Return the unit to an authorized
Inhale the medication. environment. OMRON retail outlet or distributor.

10.When treatment is complete, turn the power off and unplug the
compressor from the power outlet.

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