Omron C102 Total User manual

EN
Know your unit
How the nebulizer kit works
The medication that is pumped up through
the medication channel is mixed with
compressed air which is generated by a
compressor pump.
The compressed air mixed with medication
is turned into fine particles and sprayed
when in contact with the baffle.
How the Nasal Shower works
The solution that is pumped up through the
channel is mixed with compressed air which is
generated by a compressor pump.
The compressed air mixed with solution is
turned into fine particles ready for irrigation for
the nasal and rhino-pharyngeal cavities.
Baffle
Aerosol
Medication
Aerosol
Nozzle
Medication
Compressed Air
Aerosol Aerosol
SolutionSolution
Compressed Air
Intended use
Medical Purpose
This product is intended to be used for inhaling medication for respiratory
disorders. The nasal shower is a nasal irrigation system for rinsing the
nasal and rhino-pharyngeal cavities.
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
C102 Total and the content of this instruction manual.
Intended Patients
Persons who suffer from respiratory disorders and require inhalation of
medications or who require rinsing of their nasal and rhino-pharyngeal
cavities.
Environment
This product is intended for use in a general household.
Durable period
Durable periods are as follows, provided the product is used to nebulize
3 times a day for 10 minutes each time at room temperature (23°C).
Compressor (Main unit) 5 years
Air Tube 1 year
Nebulizer Kit 1 year
Mouthpiece 1 year
Child Mask 1 year
Adult Mask 1 year
Adapter 1 year
Nasal Shower 1 year
Air Filter 70 applications
Durable period may vary depending on usage environment.
Frequent usage of the product may shorten the durable period.
Important safety instructions (Read before use)
Warning:
1. Use the device only as nebulizer for therapeutic purposes. Any other
use is improper and may be dangerous. The manufacturer is not liable
for improper uses.
2. Do not use in anaesthetic or ventilator breathing circuits.
3. Always disconnect the power plug after use.
4. Do not to cover the ventilation slots during use. The compressor could
get hot and there is a possible risk of a burn if touched.
5. The compressor and power plug are not waterproof. Do not spill water
or other liquids on these parts. If liquid does spill on these parts,
immediately unplug the power plug and wipe off the liquid.
6. Do not attempt to repair the device. See Troubleshooting section.
7. Keep the device out of reach of unsupervised infants and children. The
device contains small pieces that can be swallowed.
8. Provide close supervision when this device is used by, on, or near
children or persons with limited capabilities.
9. For type, dose, and regimen of medication follow the instructions of your
doctor or respiratory specialist.
10. This product should not be used on patients, who are unconscious or
are not breathing spontaneously.
11. After finishing the treatment disconnect the air tube from the nebulizer
kit and from the compressor.
12. In view of their length, the power cord and air tube could constitute a
strangulation hazard.
13. Be sure to use the compressor at a place where the power plug is easily
accessible during treatment.
14. If you experience any allergic reactions or other difficulties during use,
stop using the device immediately and consult your doctor or respiratory
specialist.
15. While using this device, make sure that no mobile phone or any other
electrical devices that emit electromagnetic fields is within 30 cm. This
may result in degradation of performance of the device.
16. Do not use Nasal Shower for any other purpose except for its intended
use as a nasal irrigation device.
How to use
1. Make sure that the power switch is in the off ( )
position.
2. Plug the power plug into a power outlet.
Note: Do not place the device in a location where it
is difficult to disconnect the power cord.
3. Remove the inhalation top from the medication tank.
1) Rotate the inhalation top anti-clockwise.
2) Lift the inhalation top from the medication tank.
4. Add the correct amount of prescribed medication
into the medication tank.
5. Verify the presence of the vaporiser head inside the
medication tank.
6. Put the inhalation top back onto the medication tank.
1) Lower the inhalation top on the medication tank.
2) Rotate the inhalation top clockwise.
7. Attach the adapter, and the
Mask or mouthpiece to the
nebulizer kit tightly.
8. Attach the air tube. Twist the
air tube plug slightly and push it firmly into the air tube
connector.
9. Hold the nebulizer kit as
indicated on the right.
Follow the instructions of
your doctor or respiratory
specialist.
Caution:
Do not tilt the nebulizer kit at an angle of greater than 30 degrees in all directions.
Medication may flow into the mouth or it may result in ineffective nebulization.
10. Turn the power switch to the on (I) position. As the compressor starts,
nebulization begins and aerosol is generated. Gently inhale the
medication. Exhale through the nebulizer kit.
11. When treatment is completed, turn the power off and unplug the
compressor from the power outlet. Wind the power cord up and store it in
the compartment at the back of the device.
1
2
1
2
Preparation of the Nasal Shower
1. In order to add the solution to the nasal shower tank, lift
the upper part out of the tank as shown on the figure.
Remove the upper part.
2. Pour the solution in the tank (max 15 ml).
3. Close the nasal shower by placing back
the upper part.
4. Connect one end of the air hose to the
nasal shower and the other end to the
compressor.
Turn on the compressor to begin the
treatment.
Operation of the Nasal Shower
Operate the nasal shower by pressing the button and
release it before/during exhaling. During treatment,
hold the other nostril, to which the nasal shower is not
applied, closed with one finger.
In the case of children or patients with limited capabil-
ities, apply to the two nostrils in alternation, switching
every 10-20 seconds. Keep a handkerchief ready to
dry the nostrils if mucous overflows from the trap in the
upper part of the nasal shower.
When the mist starts disappearing from the nasal
shower the treatment is done. After use, dispose of any
solution from both upper part and tank, disassemble
the Nasal Shower to the 4 parts as indicated in section
“Know your unit” and clean the parts according to the
instructions below.
Note: NEVER INHALE WHILE IN A HORIZONTAL POSITION. NEVER TILT
THE NASAL SHOWER TO MORE THAN 60°.
Cleaning and daily disinfecting
Carefully wash your hands before cleaning and disinfecting the nebulizer
parts. Clean the parts after each use to remove residual medication. This will
prevent inefficient nebulization and reduce risk of infection.
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Adapter:
Fully disassemble the Nebulizer Kit and the Nasal Shower. Wash them in
warm water and mild, neutral detergent. Rinse them thoroughly with clean
hot tap water, gently tap to remove excess water and allow to air dry in a
clean place. It is advisable to replace the Nebulizer Kit and Nasal Shower
after some 100 to 120 treatments or after about 20 boiling cycles.
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Firstly, make sure that the power plug is unplugged from the power outlet.
Wipe clean with a soft cloth moistened with water or mild, neutral detergent.
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Adapter:
Always disinfect the parts before using the product for the first time and after
the product has not been used for an extended period of time as well as after
the last treatment of the day. If the parts are heavily stained, replace them
with new ones. The Nebulizer Kit, Nasal shower, Masks*, Mouthpiece and
Adapter can be disinfected by using a chemical disinfectant such as ethanol,
sodium hypochlorite (Milton), Quaternary ammonium (Osvan), Chlorhexidine
(Hibitane) and Amphoteric Surfactant (Tego), following product instructions
and rinsing off with clean warm water. Leave to air-dry.
Note: Never clean with benzene, thinner or a flammable chemical.
*The (non-latex) elastic bands cannot be disinfected. Remove them
when disinfecting the masks.
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also be disinfected by boiling between 15 to 20 minutes in plenty of water.
After boiling, carefully remove the parts, shake off excess water and allow to
air-dry in a clean environment.
Note: Do not boil the Mask and the Air Tube.
Replacing the Air Filter:
If the air filter has changed color, or has been used for
more than 70 applications, replace it with a new one. To
purchase the filters – see “Other Optional/Replacement
Parts” paragraph.
Remove the air filter cover using a flat screwdriver as
shown in figure; remove the filter and fit the new filter
as shown.
Put the air filter cover back in place.
Note: Do not wash or clean the air filter. If the air filter
becomes wet, replace it. Damp air filters can cause blockages.
Compressor Nebulizer
C102 Total
(NE-C102-E)
Instruction Manual
IM-NE-C102-E-01-12/2017
3A3770 rev.00
Air Tube Connector
Nozzle
Medication Tank
Vaporiser Head
Inhalation Top
Nasal Shower
Upper part
Button
Tank
(Max 15 ml)
Nasal adapter
Nozzle
O-ring
Lower part
Instruction manual
Child Mask (PVC)
Adult Mask (PVC)
Mouthpiece
Adapter
Air Tube
(PVC, 100cm)
Ventilation Slots
Power Cord
Compartment
Power Plug
Power Cord
Rear View
Nebulizer Kit
Power Switch
Ventilation Slots
Nebulizer Kit
Holder
Air Tube
Connector
Air Filter Cover
Including air filter
Compressor (Main unit)

Troubleshooting
In case of any of the below problems occur during use, first check that no
other electrical device is within 30 cm. If the problem persists, please refer to
the below.
The device does not switch on
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The device switches on but does not nebulize
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the nasal shower, check that the nasal shower is assembled correctly.
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kit.
The device suddenly stops working during operation
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reasons:
- the device was working in an environment with temperatures higher than
40°C;
- the ventilation slots were covered.
Do not attempt to repair the device. Do not open and/or tamper with the
device. No parts of the device are user serviceable. Return the device to an
authorized OMRON retail outlet or distributor.
Technical data
Product Category: Aerosoltherapy Equipment
Product Description: Compressor Nebulizer
Model (code): C102 Total (NE-C102-E)
Rating: 230V ~50Hz, (fuse: T1.6AL250V)
Power Consumption: 150VA
Operating Mode:
Continuous Use
Operating Temperature/
Humidity/Air Pressure:
+5°C to +40°C /
15% to 85%RH / 700 to 1060 hPa
Storage and Transport
Temperature/Humidity/
Air Pressure:
-20°C to +60°C / 5% to 95%RH /
500 to 1060 hPa
Weight: Approx. 1.1 kg (compressor only)
Dimensions: Approx. 145 (W) × 124 (H) × 222 (D) mm
Classifications: Type BF (Applied part): Mouthpiece,
Masks and Nasal adapter
IP21 (Ingress Protection)
Contents: Compressor, Nebulizer Kit, Nasal shower,
Air Tube (PVC, 100 cm), Mouthpiece, Adapter,
Adult Mask (PVC), Child Mask (PVC),
Instruction Manual
= Class ll
equipment
= Type BF
applied part
IP21 = Ingress
Protecion
= Power off
= Serial
number
= Consult the
instructions
for use
= Alternating
current = Power on
General Notes:
 IP classification is degrees of protection provided by enclosures in accordance with
IEC 60529. The compressor is protected against solid foreign objects of 12 mm
diameter and greater such as a finger, and against vertically falling water drops which
may cause issues during a normal operation.
 Subject to technical modification without prior notice.
 The device may not work if the temperature and voltage conditions are different to
those defined in the specifications.
 The device fulfils the provisions of the EC directive 93/42/EEC (Medical Device
Directive) and the European Standard EN13544-1:2007+A1:2009, Respiratory
therapy equipment - Part1: Nebulizing systems and their components.
Nebulizer Kit:
Appropriate Medication
Quantities: 2 ml minimum - 12 ml maximum
Residual volume of
medication: Approx. 0.7 ml
Sound: Noise level
(at 1 m distance) Approx 57 dB
Particle Size (MMAD): $SSUR[ȝP
MMAD = Mass Median Aerodynamic Diameter
Nebulization Rate
(by weight loss): **Approx. 0.35 ml/min (NaCl 0.9%)
Aerosol Output
(2 ml, 1% NaF): ***Approx. 0.25 ml
Aerosol Output Rate
(2 ml, 1% NaF): ***Approx. 0.07 ml/min
Nebulizer Kit: Result of cascade impactor measurements for particle size*
Cumulative % particle mass of sodium fluoride undersize
Cumulative Undersize%
3DUWLFOH6L]H'SȝP
Mean
Individual
Notes:
 Performance may vary with drugs such as suspensions or high viscosity. See drug
supplier’s data sheet for further details
* Measured values reflect internal data obtained by NEXT GENERATION IMPACTOR
(NGI), according to EN 13544-1:2007+A1:2009.
** The Nebulization rate is measured with saline 0.9% solution at 23°C with 3 ml of
medication. It can vary with medication and ambient conditions.
***Measured by OMRON HEALTHCARE Co., LTD.
Nasal shower:
Appropriate Solution
Quantities: 3 ml minimum - 15 ml maximum
Particle Size: RISDUWLFOHV!ȝP
Nebulization Rate
(by weight loss): more than 5 ml/min (NaCl 0.9%)
Warranty
Thank you for buying an OMRON product. This product is constructed of high
quality materials and great care has been taken in its manufacturing. It is
designed to give you every satisfaction, provided that it is properly operated
and maintained as described in the instruction manual.
This product is guaranteed by OMRON for a period of 3 years after the date
of purchase. The proper construction, workmanship and materials of this
product is guaranteed by OMRON. During this period of guarantee OMRON
will, without charge for labour or parts, repair or replace the defect product or
any defective parts.
The guarantee does not cover any of the following:
a. Transport costs and risks of transport.
b. Costs for repairs and / or defects resulting from repairs done by
unauthorised persons.
c. Periodic check-ups and maintenance.
d. Failure or wear of optional parts or other attachments other than the main
device itself, unless explicitly guaranteed above.
e. Costs arising due to non-acceptance of a claim (those will be charged for).
f. Damages of any kind including personal caused accidentally or from
misuse.
Should guarantee service be required please apply to the dealer whom the
product was purchased from or an authorised OMRON distributor. For the
address refer to the product packaging / literature or to your specialised
retailer.
If you have difficulties in finding OMRON customer services, contact us for
information.
Repair or replacement under the guarantee does not give rise to any
extension or renewal of the guarantee period.
The guarantee will be granted only if the complete product is returned
together with the original invoice / cash ticket issued to the consumer by the
retailer. OMRON reserves the right to refuse the guarantee service if any
unclear information has been given.
Optional Medical Accessories
(within the scope of EC Medical Device Directive 93/42/EEC)
Product Description Model
Nebulizer Accessory Set
(Contents: Nebulizer Kit, Adapter,
Mouthpiece, Nosepiece, Adult Mask (PVC),
Child Mask (PVC), Air Tube, Air Filter)
NEB-ASKIT-11
Other Optional/Replacement Parts
Product Description Model
Air Filter Set (Contents: 3 pieces) 3AC408
Important information regarding Electro Magnetic Compatibility (EMC)
NE-C102-E manufactured by 3A HEALTH CARE S.r.l. confirms to
EN60601-1-2:2015 Electro Magnetic Compatibility (EMC) standard.
Further documentation in accordance with this EMC standard is available
at OMRON HEALTHCARE EUROPE at the address mentioned in this
instruction manual or at www.omron-healthcare.com. Refer to the EMC
information for NE-C102-E on the website.
DISPOSAL PROCEDURE (Dir. 2012/19/EU-WEEE)
This product is not to be treated as regular household waste but must
be returned to a collection point for recycling electric and electronic
devices. Further information is available from your municipality, your
municipality’s waste disposal services, or the retailer where you
purchased your product.
Manufacturer 3A HEALTH CARE S.r.l.
Via Marziale Cerutti, 90F/G
25017 Lonato del Garda (BS)
Italy
Distributor 20521+($/7+&$5((8523(%9
Scorpius 33, 2132 LR Hoofddorp, THE NETHERLANDS
www.omron-healthcare.com
Subsidiaries OMRON HEALTHCARE UK LTD.
Opal Drive, Fox Milne, Milton Keynes, MK15 9DG, UK
www.omron-healthcare.com
OMRON MEDIZINTECHNIK HANDELSGESELLSCHAFT mbH
Gottlieb-Daimler-Strasse 10, 68165 Mannheim, GERMANY
www.omron-healthcare.com
OMRON SANTÉ FRANCE SAS
14, rue de Lisbonne, 93561 Rosny-sous-Bois Cedex, FRANCE
www.omron-healthcare.com
Made in Italy