Omron Nami Cat User manual

PM-1840-01-02/2020
New Product Information Sheet
Specifications subject to change
© OMRON HEALTHCARE EUROPE B.V.
Model (code):
Nami Cat (NE-C303K-KDE)
Versions
Remark
Date
1
29/04/2020
2
Full version, with key visual
02/07/2020

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Nami Cat
Cute outside. Powerful inside.
Product Name: Nami Cat (NE-C303K-KDE)
Product Description: Compressor Nebulizer
Product Category: Aerosoltherapy Equipment
Logistic information
Technical data
Features
Packaging content
- Specially designed for children
- Efficiently delivers medication into
the lungs
- Fast treatment with the Nebulization
rate of 0.35 ml/min
- Compressor
- Nebulizer Kit
- Adult MASK (PVC)
- Child Mask (PVC)
- Air Tube (PVC, 100 cm)
- Mouthpiece
- Adapter
- Instruction Manual
Package Amount Approximate weight
Approximate
dimensions
Main Unit 1 1.22 kg
148 mm (w) x 180
mm (d) x 135 mm
(h)
Single Package 1 1.4 kg 152 mm x 233 mm x
144 mm
Master Carton 6 9.0 kg 326 mm x 180 mm x
730 mm
EAN code NE-C303K-KDE: 4015672112452

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Product description:
Compressor Nebulizer
Product Category:
Aerosoltherapy Equipment
Model (code): Nami Cat (NE-C303K-KDE)
Rating:
230V ~50Hz
Power Consumption:
150VA
Operating Mode:
Continuous use
Operating conditions:
+5°C to +40°C / 15% to 85%RH / 700 to 1060 hPa
Storage / Transport conditions:
-20°C to +60°C / 5% to 95%RH / 500 to 1060 hPa
Classifications:
Type BF (Applied part): Mouthpiece and
Masks
Class II (Protection against electric shock)
IP classification:
IP21
Weight of Compressor:
Approx. 1.1 kg (compressor only)
Dimensions of Compressor:
Approx. 180 (W) x 135 (H) x 148 (D) mm
Contents:
Compressor,
Nebulizer Kit, Air Tube (PVC,100 cm),
Mouthpiece, Adapter, Adult Mask
(PVC),
Child Mask (PVC), Instruction Manual
Appropriate Medication Qty:
2 ml minimum - 12 ml maximum
Residual volume of Medication:
Sound: Noise level (at 1 m
distance):
Particle Size (MMAD):
Approx. 0.7 ml
Approx. 58 dB
Approx. 3.4 μm
Nebulization Rate (by weight loss):
Approx. 0.35 ml/min (NaCl 0.9%)
Aerosol Output (2 ml, 1% NaF):
Approx. 0.21 ml
Aerosol Output Rate (2 ml, 1%
NaF):
Approx. 0.06 ml/min

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General description
OMRON is introducing the Nami Cat, a new addition to its Compressor
Nebulizer portfolio. This product was developed in conjunction with
respiratory therapists for the successful treatment of respiratory disorders
such as asthma, chronic bronchitis, allergies, etc.
This is a medical device. Operate the device only as instructed by your
doctor and/or respiratory therapist.
.
Packaging content
The manufacturer produces Nami Cat with the applicable accessories
included, necessary for the application of its intended purpose.
1. Compressor
2. Nebulizer Kit
3. Child Mask (PVC)
4. Adult Mask (PVC)
5. Mouthpiece
6. Adapter
7. Air Tube (PVC, 100cm)
8. Instruction Manual
The complete set of the medical device is specified in the Instruction
Manual in the “Know your unit” section.
Purpose
The nebulizer is a medical device that is intended to be used for inhaling
medication to treat respiratory disorders.1
Application field
This product is intended for use in a medical facility, such as hospital,
clinic and doctor’s office, and in general household.

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Intended User
Persons who suffer from respiratory disorders and require inhalation of
medications. Before using this device please refer to “Important Safety
Instructions” section of the Instruction Manual.
Indications for use
This product is intended to be used for inhaling medication for
respiratory disorders.
Features (Particularities)
•Specially designed for children
•Efficient medication delivery into the lungs
•MMAD 3.4 μm, Nebulization rate 0.35 ml/min, Medication tank 2-
12 ml
Description of operating principle
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 to use the device
Follow IM for detailed instructions!
Main steps:
1. Make sure that the power switch is in the off position.
2. Plug the power plug into a power outlet.
3. Remove the inhalation top from the medication tank.

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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.
7. Attach the adapter, and the mask or mouthpiece to the nebulizer kit
tightly.
8. Attach the air tube.
9. Hold the nebulizer kit straight. Do not tilt more than 30 degrees in all
directions. Follow the instructions of your doctor or respiratory therapist.
10. Turn the power switch to the on position to start nebulization. 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.
12. Clean and disinfect all (disassembled) parts.
Optional medical accessories
Product Description
Model
Nebulizer Kit
NEB6024
Adult Mask (PVC)
NEB6007
Child Mask (PVC)
NEB6008
Mouthpiece
NEB6019
Adapter
NEB6015
Air Tube (PVC, 100 cm)
NEB6004
Nasal shower*
NEB6014
Other optional/replacement parts
Product Description
Model
Air Filter Set (Contents: 3
pieces)
3AC408

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Materials used in main device
Part’s name Material Grade Colorant
Colorant
grade
Housing, air
filter cover
and
switch
ABS (acrylonitrile
butadiene styrene)
ESTADIEN
E
1640 Blue Pantone
278 U
Air Filter PP (polypropylene)
Geotess
350
White RAL 9010
Legs
EPDM (Ethylene-
Propylene Diene
Monomer)
50 Shore A Grey RAL 7035
AC Cord
PVC (polyvinyl
chloride)
UL 94V-0 White RAL 9010
Rating label PET (polyester)
RI-COTE
36 AP900
Grey
Pantone
877C
Package Cardboard
280g/m2
+ TT44/E
White RAL 9010
Instruction
Manual
Paper 70g/m2 White RAL 9010
Materials for accessories
Item
/part’s name
Materi
al
Grade
Colorant
Colorant
grade
Medication Tank and
Inhalation Top of the
Neb kit, Mouthpiece,
Adapter
PP
(polypropylene)
HP500N
Transpare
nt
RAL 9016
Vaporiser Head
PP
(polypropylene)
HP500N
Blue
Variant 668
Adult Mask and Child
Mask
PVC (polyvinyl
chloride) –
phthalate free
AM281/F
Transpare
nt light
blue
Pantone
279C
Air Tube
PVC (polyvinyl
chloride) –
phthalate free
H4880TF
AM276/D
Transpare
nt light
blue
Pantone
279C

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Elastic band
PET (Polyester),
Spandex
1680 Blue
Pantone
288C
Title page of Instruction Manual

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Unfolded package design of main device and accessories
Main device:
Accessories: Nasal Shower NEB6014

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List of Harmonized EN Standards
The device is classified as a medical device, class IIa.
Applicable Medical Device Directive (93/42/EEC) standards:
EN 13544-1:2007+A1 :2009
EN ISO 15223-1:2016
EN 1041:2008+A1 :2013
UNI EN ISO10993-1:2010
EN 10993-5 :2009
EN 10993-10:2010
EN 60601-1:2006/A11 :2011/A1 :2013
EN 60601-1-2:2015
EN 60601-1-11:2015
EN 60601-1-6:2010+A1:2015
EN 62366-1:2015
EN ISO 14971:2012
Cleaning of the device
Wash hands thoroughly before cleaning and disinfecting the nebulizer
parts. Always disinfect the device parts before first use, and if the device
has not been used for a long time, and also after the last treatment
session of a day. After each use remove any remaining medication and
clean the nebulizer parts. This will prevent inefficient nebulization and
reduce risk of infection.
Please refer to the instructions below.
Cleaning the Nebulizer Kit, Mask, Mouthpiece and Adapter:
Fully disassemble the nebulizer kit. Wash the parts 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 C101 Essential nebulizer kit after some 100 to
120 treatments or after about 20 boiling cycles.
Cleaning the Compressor and Air Tube:
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.
Removing condensation from the Air Tube:
If moisture remains in the air tube, follow the procedure described below.

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Make sure that the air tube is connected to the compressor. Disconnect
the air tube from the nebulizer kit. Turn on the compressor and dry the
air tube by passing air through it.
Disinfecting the Nebulizer Kit, Mask, Mouthpiece and 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, Mask, Mouthpiece,
Nosepiece 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.)
• boiling: The Nebulizer Kit, Mouthpiece and Adapter can 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 colour, 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.)
Maintenance
This device does not require any regular maintenance.

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Storage
Do not store the air tube while there is moisture remaining inside.
•Never leave the nebulizer kit with medication near the ventilation slots,
this is to avoid medication entering the device.
• Store the parts in a clean location for avoiding infection.
• Do not use or store the device in humid locations.
• Do not use or store the device while the air tube is creased.
Storage and transportation:
Temperature range: -20°C to +60°C
Humidity range: 5% to 95%RH
Atmospheric pressure: 500 - 1060hPa
Warnings
(Warning indicate a potentially hazardous situation which, if not avoided,
could result in death or serious injury.)
It is important that you read all the warnings and precautions included in
this instruction manual because they are intended to keep you safe,
prevent injury and avoid a situation that could result in damage to the
unit!
1. Use the device only as inhalator 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 may contain small pieces that can be swallowed.
8. Provide close supervision when this device is used by, on, or near
children or invalids.

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9. For type, dose, and regime of medication follow the instructions of
your doctor or respiratory therapist.
10. This product should not be used on patients, who are unconscious
or are not breathing spontaneously.
11. After finishing the treatment remember to disconnect the air tube
from the nebulizer kit and from the compressor.
12. In view of their length, the power plug 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.
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 oils, decoctions and tinctures from herbs for inhalation
in the compressor nebulizer.
Disposal
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.
Transportation and storage conditions
Do not store the device in the following situations:
• If the device is wet.
• Locations exposed to extreme temperatures, humidity, direct
sunlight, dust or corrosive vapors such as bleach.
• Locations exposed to vibrations, shocks or where it will be at an
angle.
Storage and transportation conditions:
1. Temperature range: -20 to +60°C
2. Humidity range: 10 to 90% RH

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Warranty and lifetime
The warranty will be granted only if the complete product is returned
together with the original invoice / cash ticket issued to the consumer by
the retailer.
Warranty of the compressor (main unit): 3 years.
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).
Durable period may vary depending on usage environment.
Compressor (Main unit): 5 years
Air Tube / Nebulizer Kit / Mouthpiece / Child Mask / Adult Mask /
Adapter: 1 year;
Air Filter: 70 applications
Frequent usage of the product may shorten the durable period.
Repair
Do not attempt to repair the device. Do not open and/or tamper with the
device.
During the period of warranty OMRON will, without charge for labour or
parts, repair or replace the defect product or any defective parts. Repair
or replacement under the warranty does not give rise to any extension or
renewal of the warranty period.
Servicing
No parts of the device are user serviceable. Return it to an authorized
OMRON retail outlet or distributor in case of any problem listed in
Troubleshooting chapter of the Instruction Manual
LEGAL MANUFACTURER &
PRODUCTION FACILITY
3A HEALTH CARE S.r.l.
Via Marziale Cerutti, 90F/G
25017 Lonato del Garda (BS),
Italy
DISTRIBUTOR
OMRON HEALTHCARE EUROPE
B.V.
Scorpius 33, 2132 LR Hoofddorp,
THE NETHERLANDS