Omron X105 Advanced User manual

PM-2031-01-03/2021
New Product Information Sheet
Specifications subject to change
© OMRON HEALTHCARE EUROPE B.V.
Model (code):
X105 Advanced (NE-C105-EO)
Versions
Remark
Date
1
w/o key visual
08/03/2021

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PM-2031-01-03/2021
X105 Advanced
Highly efficient Nebulizer for frequent use.
Product Name (code): X105 Advanced (NE-C105-EO)
Product Description: Compressor Nebulizer
Product Category: Aerosoltherapy Equipment
Logistic information
Features
Packaging content
- Provides efficient medication
deposition in the lungs to treat
conditions such as bronchitis,
bronchiolitis or asthma
- Advanced Valve Technology
maximizes the amount of medication
during inhalation and reduces
medication loss during exhalation by
synchronizing the flow
- MMAD 2,65 μm, Medication tank 2-
12 ml
- Compressor
- Nebulizer Kit
- Adult Mask (PP+TPE)
- Child Mask (PP+TPE)
- Air Tube (PVC, 150 cm)
- Mouthpiece Set
- Adapter
- Carrying Bag
- 5 pcs Spare Air Filters
- Power Cord with EU plug
- Power Cord with UK plug
- Instruction Manual
Package Amount
Approximate
weight
Approximate dimensions
(w) x (d) x (h)
Main Unit
(compressor only)
1 1.3 kg 180 mm x 180 mm x 104 mm
Single Package 1 2.1 kg 193 mm x 265 mm x 143 mm
Master Carton 4 9.0 kg 278 mm x 790 mm x 173 mm
UDI-ID (Unique
Device Identifier) /
EAN code

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Technical data
Product description:
Compressor Nebulizer
Product Category:
Aerosoltherapy Equipment
Model (code): X105 Advanced (NE-C105-EO)
Rating:
230V ~50Hz
Power Consumption:
140VA
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. 1.3 kg (compressor only)
Dimensions of Compressor:
Approx.
Ø 180 x 104 (H) mm
Contents:
Compressor
, Power Cord with EU Plug, Power
Cord with UK plug
, Nebulizer Kit, Air Tube
(PVC,
150 cm), Mouthpiece, Adapter, Adult Mask,
C
hild Mask, Carrying Bag, 5 pcs Spare Air Filters,
Instruction Manual
Appropriate Medication Qty:
2 ml minimum - 10 ml maximum
Residual volume of Medication:
Sound: Noise level (at 1 m
distance):
Particle Size (MMAD):
Approx.
0.7 ml
Approx. 5
5 dB
Approx. 2.65 μm
Aerosol Output (2 ml, 1% NaF):
Approx. 0.7 ml
Aerosol Output Rate (2 ml, 1%
NaF):
Approx.
0.12 ml/min

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General description
OMRON is introducing the X105 Advanced, 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 X105 Advanced with the applicable
accessories included, necessary for meeting its intended purpose.
1. Compressor
2. Nebulizer Kit
3. Child Mask (PP+TPE)
4. Adult Mask (PP+TPE
5. Mouthpiece
6. Adapter
7. Air Tube (PVC, 150cm)
8. Power cord with EU plug
9. Power cord with UK plug
10. 5 pcs Spare Air Filters
11. Carrying Bag
12. 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.
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.
•Legally certified medical experts, such as doctor, nurse and
therapist or healthcare personnel or patient under the guidance of
qualified medical experts.
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)
•Provides efficient medication deposition in the lungs to treat
conditions such as bronchitis, bronchiolitis, COPD or asthma
•Advanced Valve Technology maximizes the amount of medication
during inhalation and reduces medication loss during exhalation by
synchronizing the flow
•MMAD 2,65 μm, Medication tank 2-12 ml
•Suitable for the whole family
•Long-life compressor

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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.
Nebulizer Kit with Valve Technology
The X105 Advanced nebulizer is equipped with a breath-enhanced valve
system
which allows the maximum amount of medication to be inhaled by the
patient. It optimizes the flow of medication during inhalation and reduces
medication loss during exhalation. By synchronizing the flow of aerosol
with the breathing, the therapeutic effect of the inhaled medication is
optimized.
Note: Only using the mouthpiece enables the synchronized functioning
of the nebulizer!
Inhalation phase:
During inhalation, the inhalation
valve (A) opens and air enters the
nebulizer. The air is mixed with the
generated aerosol (B) and inhaled
through the mouthpiece by the
patient (C). In this phase the
exhalation valve (D) remains
closed preventing aerosol
from being wasted.

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Exhalation phase:
When exhaling through the
mouthpiece, the inhalation valve
(A) of the nebulizer closes,
preventing aerosol to leave the
nebulizer. The aerosol generated
remains in the nebulizer and
becomes available for the next
inhalation phase. The exhaled air
leaves the mouthpiece through the
exhalation valve (D).
How to use the device
Follow IM for detailed instructions!
Main steps:
1. Make sure that the power button is in the off position.
2. Insert the power cord into the compressor socket and then plug the
power plug into a power outlet.
3. Remove the inhalation top from the medication tank.
4. Verify that the vaporiser head is attached to the inhalation top.
5. Add the correct amount of prescribed medication into the medication
tank.
6. Put the inhalation top back onto the medication tank
Using the mouthpiece:
7a. Assemble the mouthpiece
7b. Attach the mouthpiece to the nebulizer kit and press the cap onto the
inhalation top.
7c. Keep the mouthpiece in the mouth during both inhalation and
exhalation in order to get the maximal benefit by the valve system.
Using the adult mask:
7d. Attach the adult mask to the nebulizer kit
Using the child mask and adapter:

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7e. Attach the child mask to the support adapter and connect it to the
nebulizer kit.
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. Press the power button to power the compressor. As the compressor
starts, nebulization begins, and aerosol is generated. Gently inhale the
medication. Exhale through the mouthpiece.
11. When treatment is completed, press the power button again to power
off the device.
Optional medical accessories
Product Description
Model
Nebulizer Kit
NEB6026
Air Tube
NEB6016
Mouthpiece Set (Contents: Mouthpiece
with cap, Exhalation Valve, Inhalation
Valve)
NEB6027
Child Mask (incl. elastic band)
NEB6028
Adult Mask (incl. elastic band)
NEB6029
Support Adapter for Child Mask
NEB6030
Nasal shower
NEB6014
Other optional/replacement parts
Product Description
Model
Power Cord with EU plug
3AC459
Power Cord with EU plug
3AC460
Air Filter Set (Contents: 5 pieces)
3AC458

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Materials used in main device
Part’s name Material
Grade
Colorant
Colorant
grade
Housing and
air filter cover
ABS (acrylonitrile
butadiene
styrene)
ESTADIEN
E
1640 White WT-001
Air Filter
PP
(polypropylene)
Geotess
350 White RAL 9010
Legs
EPDM (Ethylene-
Propylene Diene
Monomer)
50 Shore A Grey RAL 7035
AC Power
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
Warranty
card Paper 70g/m2 White RAL 9010
Carrying Bag 600D Oxfond
Cloth
AAA high
quality
113 high temp.
S-3BG220%,
121 low temp.
E-RGFL100%,
133 high temp.
S-5BL100%,514
Glacial acid
3.5

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Materials for accessories
Item/part’s name
Material
Grade
Colorant
Colorant
grade
Medication Tank
and Support
Adapter for Chil
d
Mask
PP (polypropylene) HP500N Transparent
No
additional
colorant
Inhalation Top of
the Neb kit PP (polypropylene)
HP500N White WT-001
Mouthpiece
with
Cap
PP (polypropylene)
and
TPE (T
hermoplastic
elastomers)
HP500N
TM7MED
White
Light Grey
WT-001
GY-003
Inhalation and
Exhalation valves
Silicone PT SA 60 Light Grey GY-003
Vaporiser Head PP (polypropylene) HP500N
Transparent
Blue
Pantone
T225-1-2
Adult Mask and
Child Mask
PP (polypropylene)
and
TPE (
Thermoplastic
elastomers)
HP500N
TM5LFT
Transparent
Light Grey
No
additional
colorant
GY-003
Air Tube
PVC (polyvinyl
chloride) –
phthalate free
H4880TF
AM276/D
Tran
sparent
light blue
Pantone
279C
Elastic band
PET (Polyester),
Spandex 1680 Blue
Pantone
288C
Bag for
accessories PE (polyethylene) 50 microns
Transparent
No
additional
colorant in
it