Omron NE-C802 Instruction Manual

Compressor Nebulizer
Instruction Manual
IM-NE-C802-E(V)-01-06/2013
1679035-9A
Intended use
Medical Purpose
This product is intended to be used for inhaling medication for respiratory
disorders.
Intended User
• Legally certified medical experts, such as doctor, nurse and therapist.
• Caregiver or patient under the guidance of qualified medical experts for
home treatment.
• The user should also be capable of understanding general operation of
NE-C802 and the content of instruction manual.
Intended Patients
This product should not be used by patients, who are unconscious or are
not breathing spontaneously.
Environment
This product is intended for use in a medical facility, such as Hospital,
clinic and doctor's office, and in a room of general household.
Durable period
Durable periods are as follows, provided the product is used to nebulize
2 ml of medication twice a day for 8 minutes each time at room
temperature (23°C).
Durable period may vary depending on usage environment.
Frequent use of the product may shorten the durable period.
Compressor (Main unit) 5 years
Nebulizer Kit 1 year
Mouthpiece 1 year
Nosepiece 1 year
Air Tube (PVC, 100cm) 1 year
Air Filter 60 days
Mask (PVC)/(SEBS) 1 year
Precautions for use
Warnings and cautions described in the instruction manual should be
observed.
Thank you for purchasing the OMRON COMP AIR basic.
This product was developed in conjunction with respiratory therapists
for the successful treatment of asthma, chronic bronchitis, allergies
and other respiratory disorders.
This is a medical device. Operate the device only as instructed by
your doctor and/or respiratory therapist.
Aerosol
How the nebulizer kit works
The medication that is pumped up
Medication Channel
through the medication channel is
mixed with compressed air which is
Medication
generated by a compressor pump.
The medication is turned into fine
particles and sprayed when in contact
with the compressed air.
Manufacturer OMRON HEALTHCARE Co., Ltd.
EN
53, Kunotsubo, Terado-cho, Muko, Kyoto, 617-0002 JAPAN
EU-representative OMRON HEALTHCARE EUROPE B.V.
Scorpius 33, 2132 LR Hoofddorp, THE NETHERLANDS
www.omron-healthcare.com
OMRON HEALTHCARE MANUFACTURING VIETNAM CO.,
Production facility LTD.
Binh Duong Province, VIETNAM
OMRON HEALTHCARE UK LTD.
Opal Drive, Fox Milne, Milton Keynes, MK15 0DG, U.K.
OMRON MEDIZINTECHNIK HANDELSGESELLSCHAFT mbH
Subsidiary Gottlieb-Daimler-Strasse 10, 68165 Mannheim, GERMANY
www.omron-medizintechnik.de
OMRON SANTÉ FRANCE SAS
14, rue de Lisbonne, 93561 Rosny-sous-Bois Cedex, FRANCE
Know your unit
Compressor (Main Unit) x 1 Bottom view
Nebulizer Kit Holder
Air Tube Connector
Power Switch
Nebulizer Kit x 1 Mouthpiece x 1
Accessory Adapter
Inhalation Top
Adult Mask (PVC) x 1
Vaporizer Head
Medication Tank
Nozzle
Air Tube
Connector
Air Tube
(PVC, 100cm) x 1
Spare Air Filters x 5
Important safety instructions
Read all the information in the instruction manual and any other literature included in
the box before using the device.
Indicates a potentially hazardous situation which, if not avoided, could result in
Warning
:
serious injury.
(Usage)
• For type, dose, and regime of medication follow the instructions of your doctor or
respiratory therapist.
• If you feel anything unusual during use, stop using the device immediately and
consult your doctor.
Nozzle
• Do not use only water in the nebulizer for inhaling purposes.
• Keep the device out of the reach of unsupervised infants and children. The device
may contain small pieces that can be swallowed.
• Do not store the air tube while there is moisture or medication remaining inside.
• Do not use or store the device where it may be exposed to noxious fumes or volatile
substances.
• Do not use the device where it may be exposed to flammable gas.
• Do not cover the compressor with a blanket, towel, or any other type of cover during
use.
• Always dispose of any remaining medication after use, and use fresh medication each
time.
Compressed Air
• Do not use in anaesthetic or ventilator breathing circuits.
• Store the parts in a clean location for avoiding infection.
(Risk of electrical shock)
• Never plug or unplug the AC adapter with wet hands.
• The compressor and the AC adapter are not waterproof. Do not spill water or other
liquids on these parts. If liquid does spill on these parts, immediately unplug the AC
adapter and wipe off the liquid with gauze or other absorbent material.
• Do not immerse the compressor in water or other liquid.
• Do not use or store the device in humid locations.
• Do not operate the device with a damaged power cord or plug.
• Keep the power cord away from heated surfaces.
• Use only original OMRON AC adapter. Use of unsupported AC adapter may damage
the device.
(Cleaning and disinfecting)
Observe the rules below when cleaning or disinfecting parts. Failure to observe these
rules may result in damage, inefficient nebulization or infection. For the instructions,
refer to "Cleaning and disinfecting" section.
• Clean and disinfect the nebulizer kit, mask, mouthpiece or nosepiece before using
them when as follows:
- 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
• 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 in the parts.
Made in Vietnam
Indicates a potentially hazardous situation which if not avoided, may result in
Caution:
minor or moderate injury, or physical damage.
(Usage)
• Provide close supervision when this device is used by, on, 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
60 days, replace it with a new one.
Power Connector
• Do not tilt the nebulizer kit at an angle of greater than 45 degrees in all directions or
shake it while in use.
• 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.
• Do not add more than 10 ml of medication to the medication tank.
• 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
consent.
• Do not subject the device to any strong shocks such as dropping on the floor.
Air Filter Cover
• Do not jab the nozzle of the medication tank with a pin or any sharp object.
*Air filter inside
• Do not insert fingers or objects inside the compressor.
• Do not disassemble or attempt to repair the compressor or AC adapter.
• Do not leave the device in extreme hot or cold temperature, or under direct sunlight.
• Do not use the device while sleeping or if drowsy.
• Approved for human use only.
Nosepiece x 1
• The compressor may become hot during operation.
• Do not touch the compressor for other than necessary operation such as turning off
the power while nebulizing.
• To avoid the medication residue on the face, be sure to wipe the face after removing
the mask.
• To avoid injury to the nose mucosa, do not squeeze the nosepiece into the back of
the nose.
• Do not use a damaged nebulizer kit, mouthpiece or nosepiece.
(Risk of electrical shock)
Child Mask (PVC) x 1
• Always unplug the AC adapter from the power outlet after use and before cleaning.
• Plug the device into the appropriate voltage outlet. Do not overload power outlets or
use extension cords.
• Do not misuse the power cord of AC adapter.
• Do not wind the power cord around the compressor or AC adapter.
• Do not pull the power cord of AC adapter.
• Changes or modifications not approved by OMRON HEALTHCARE will void the
user warranty.
• Always remove the AC adapter from the device after use and before cleaning.
(Cleaning and disinfecting)
Observe the rules below when cleaning or disinfecting parts. Failure to observe these
rules may result in damage, inefficient nebulization or infection. For the instructions,
refer to "Cleaning and disinfecting" section.
AC Adapter x 1
• 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.
Storage Bag x 1
• When disinfecting parts by boiling, make sure that the container does not boil dry.
Instruction Manual
Otherwise it may also result in fire.
Warranty Card
General Safety Precautions:
• Inspect the device before using them each time, and check that there are no
problems. In particular, be sure to check the following:
- That the nozzle or air tube are not damaged.
- That the nozzle is not blocked.
- That the compressor operates normally.
• When using this device, there will be some noise and vibration caused by the pump in
the compressor. There will also be some noise caused by the emission of compressed
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.
• Do not use the device at temperatures greater than +40°C.
• Make sure that the air tube is securely attached to the compressor and nebulizer kit,
and does not come loose.
• To completely isolate the device from the power source unplug the plug from the
power source.
Keep these instructions for future reference.
Important information regarding Electro Magnetic Compatibility (EMC)
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 EN60601-1-2:2007 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.
This medical device manufactured by OMRON HEALTHCARE conforms to this
EN60601-1-2:2007 standard for both immunity and emissions.
Nevertheless, special precautions need to be observed:
• Do not use mobile (cellular) telephones and other devices, which generate strong
electrical or electromagnetic fields, near the medical device. This may result in
incorrect operation of the unit and create a potentially unsafe situation.
Recommendation is to keep a minimum distance of 7 m. Verify correct operation of
the device in case the distance is shorter.
Further documentation in accordance with EN60601-1-2:2007 is available at OMRON
HEALTHCARE EUROPE at the address mentioned in this instruction manual.
Documentation is also available at www.omron-healthcare.com.
Correct Disposal of This Product
(Waste Electrical & Electronic Equipment)
This marking shown on the product or its literature, indicates that it should not be
disposed of, with other household wastes at the end of its working life. To prevent
possible harm to the environment or human health from uncontrolled waste disposal,
please separate this product from other types of wastes and recycle it responsibly to
promote the sustainable reuse of material resources.
Household users should contact either the retailer where they purchased this product,
or their local government office, for details of where and how they can return this item
for environmentally safe recycling.
Business users should contact their supplier and check the terms and conditions of the
purchase contract. This product should not be mixed with other commercial wastes for
disposal.
Optional Medical Accessories
(within the scope of EC Medical Device Directive 93/42/EEC)
Name Model
Nebulizer Kit & Mouthpiece Set NEB-NSET3-82E
Adult Mask (PVC) NEB-MSLP-E
Child Mask (PVC) NEB-MSMP-E
Adult Mask (SEBS) NEB-MSLS-E
Child Mask (SEBS) Set NEB-MSSS-E
Mouthpiece NEB-MP-E
Nosepiece NEB-NP-E
Air Tube (PVC, 100cm) NEB-TP-82E
NEB-AC-82E
AC Adapter
(6V06ASW-E)
Other Optional/Replacement Parts
Name Model
Air Filters x 5 NEB-AFR-30E