Omron X105 Advanced Manual de usuario

PM-2031-01-03/2021

New Product Information Sheet

Specifications subject to change

Model (code):

X105 Advanced (NE-C105-EO)

Versions

Remark

Date

w/o key visual

08/03/2021

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

PM-2031-01-03/2021

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,

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

PM-2031-01-03/2021

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.

PM-2031-01-03/2021

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

PM-2031-01-03/2021

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.

PM-2031-01-03/2021

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:

PM-2031-01-03/2021

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

PM-2031-01-03/2021

Materials used in main device

Part’s name Material

Grade

Colorant

grade

Housing and

air filter cover

ABS (acrylonitrile

butadiene

styrene)

ESTADIEN

1640 White WT-001

Air Filter

(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

PM-2031-01-03/2021

Materials for accessories

Item/part’s name

Material

Grade

Colorant

grade

Medication Tank

and Support

Adapter for Chil

Mask

PP (polypropylene)

HP500N Transparent

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

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

additional

colorant in

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