Omron NE-C803, NE-C803-E Instruction Manual

NE-C803-E_A_M09_140715.pdf

Compressor Nebulizer

NE-C803 (NE-C803-E)

Instruction Manual

IM-NE-C803-E-01-05/2014

8300641-7A

14G1762

Introduction

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.

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 medication is turned into fine particles and sprayed when in contact with the compressed air.

Aerosol

Nozzle

Compressed Air

Medication Channel

Medication

Before using the device

Contents

Before using the device

Introduction ................................................................................................................. 2

Intended use ............................................................................................................... 3

Important safety instructions ....................................................................................... 4

Know your unit ............................................................................................................ 7

Optional Medical Accessories ..................................................................................... 8

Other Optional/Replacement Parts ............................................................................. 8

Operating instructions

How to use .................................................................................................................. 9

Care and maintenance

Cleaning and disinfecting.......................................................................................... 13

Removing condensation from the air tube ................................................................ 16

Changing the air filter................................................................................................ 16

Troubleshooting ........................................................................................................ 17

Technical data ........................................................................................................... 18

Guarantee ................................................................................................................. 21

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-C803 and the content of this instruction manual.

Intended Patients

This product should not be used on 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 7.5 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.

Important safety instructions

Read all the information in the instruction manual and any other literature included in the box before using the device.

Warning:

Indicates a potentially hazardous situation which, if not avoided, could result in 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.

• Do not use only water in the nebulizer for inhaling purposes.

• Keep the device out of 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.

• Do not use in anaesthetic or ventilator breathing circuits.

• Store the parts in a clean location to avoid 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.

Caution:

Indicates a potentially hazardous situation which if not avoided, may result in 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.

• 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.

• Do not jab the nozzle of the medication tank with a pin or any sharp object.

• 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.

• 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)

• 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.

• 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.

• When disinfecting parts by boiling, make sure that the container does not boil dry. Otherwise it may also

result in fire.

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.

Know your unit

AC Adapter x 1

Storage Bag x 1

Instruction Manual

Rear View

Power Connector

Air Filter Cover *Air filter inside

Compressor (Main Unit) x 1

Nebulizer Kit Holder

Air Tube Connector

Power Switch

Spare Air Filters x 5Air Tube

(PVC, 100cm) x 1

Mouthpiece x 1

Child Mask (PVC) x 1

Adult Mask (PVC) x 1

Nebulizer Kit x 1

Air Tube Connector

Inhalation Top

Vaporizer Head

Nozzle

Medication Tank

Nosepiece x 1

Optional Medical Accessories

(within the scope of EC Medical Device Directive 93/42/EEC)

Product description Model

Nebulizer Kit & Mouthpiece Set NEB-NSET3-83E

Nebulizer Kit & Adult Mask (PVC) & Air Tube Set NEB-NSET4-83AP

Nebulizer Kit & Child Mask (PVC) & Air Tube Set NEB-NSET5-83AP

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

AC Adapter HHP-CF01

Other Optional/Replacement Parts

Product description Model

Air Filters x 5

NEB-AFR-30E

Operating instructions

How to use

Warning:

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

For the instructions, refer to “Cleaning and disinfecting” section.

Make sure that the power switch is in the off ( ) position.

Connect the AC adapter to the compressor and plug the power plug into a power outlet.

Remove the inhalation top together with vaporizer head from the medication tank.

Note: If the vaporizer head came off the inhalation top and fell into the medication tank, remove it out of the tank.

Add the correct amount of prescribed medication to the medication tank.

Make sure that the vaporizer head is securely attached to the inhalation top.

Note: The sizes of the left- and right-hand attached parts of the vaporizer head are not the same. If the vaporizer head is not attached in the correct orientation, it will not nebulize correctly.

Put the inhalation top back inside the medication tank.

1) Align the protrusion on the inhalation top with the indent on the medication tank, as shown.

2) Rotate the inhalation top clockwise until the arrow mark on it and the alignment mark on the medication tank are aligned, and they click in place.

Arrow mark

Alignment mark

Small

Large

Attach the mask, mouthpiece or nosepiece to the nebulizer kit tightly.

Note: Make sure that these attachments are fitted in such a way that the handle is positioned away from the patient. Otherwise, medication may be sprayed on patient’s skin or clothes.

Attach the air tube. Push the air tube plugs firmly into the air tube

connectors.

Handle Handle

The nebulizer kit can be fixed on the compressor.

Hold the nebulizer kit as indicated on the right. Follow the instructions of your doctor or respiratory

therapist. Exhale as normal through mouthpiece, mask or through the nose.

Caution:

Do not tilt the nebulizer kit at an angle of greater than 45 degrees in all directions. Medication may flow into the mouth or it may result in not nebulizing effectively.

10.

Press the power switch to the on ( ) position. As the compressor starts, nebulization begins and aerosol is generated. Inhale the medication.

11.

When treatment is complete, turn the power off. Unplug the AC adapter from the power outlet and disconnect it from the compressor.

Note: Securely hold and press the power plug down to disconnect the AC adapter.

Caution:

Do not pull the power cord. Damage may be caused.

Right angle

45°45°

Compressor

Power plug

Care and maintenance

Cleaning and disinfecting

Caution: Handling the Vaporizer Head

• Always wash the vaporizer head after each use.

• Do not use a brush or pin to clean the vaporizer head.

• When disinfecting the parts by boiling, be sure to boil them in plenty of water.

• Do not boil vaporizer head together with objects other than applicable nebulizer accessories.

Cleaning

Clean the parts after each use to remove residual medication. This will avoid inefficient nebulization or infection.

■Washable parts

• Nebulizer Kit (Inhalation top, Medication tank), Mask (PVC)/(SEBS), Mouthpiece, Nosepiece

Wash them in warm water and mild detergent (neutral detergent). Rinse them thoroughly with clean hot tap water and allow to air dry in a clean place.

• Vaporizer Head

Wash it with running water.

■Non-washable parts

• Compressor, 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 detergent (neutral detergent).

• Air Filter

Do not wash or clean the air filter. If the air filter becomes wet, replace it. Damp air filters can cause blockages.

Disinfecting

Disinfect the parts once a week. If the parts are heavily stained, replace them with new ones.

To select a method for disinfection, refer to the table on page 14.

: applicable X: not applicable

Disinfecting

method

(See the next page)

Parts

Mouthpiece

Nosepiece

Nebulizer Kit

Adult Mask (SEBS)

(optional)

Child Mask (SEBS)

(optional)

Adult Mask (PVC)

Child Mask (PVC)

Air Tube

(PVC, 100cm)

Air Filter

Materials

(Vaporizer Head: PC)

Mask: SEBS

Band: Rubber

(non-latex)

Adapter: PP

Mask: PVC

(Phthalate free)

Band: Rubber

(non-latex)

PVC

(Phthalate free)

Polyester

Alcohol

oo o o o X X

Disinfecting ethanol

Sodium hypochlorite

oo o o o X X

Milton*

(0.1%, 15min.)

Quaternary ammonium

oo o o o X X

Osvan*

(0.1%, 10min.)

Chlorhexidine

oo o o o X X

Hibitane*

(0.5%, 30min.)

Amphoteric

Surfactant

oo o o o X X

Tego 51*

(0.2%, 15min.)

Boiling

oo o o X X X

A. Use a commercially available disinfectant. Follow the instructions provided by the

disinfectant manufacturer.

Note: Never clean with benzene or thinner.

B. Parts may be boiled between 15 to 20 minutes.

After boiling, carefully remove the parts, shake off excess water and allow to air dry in a clean environment.

* an example of commercially available disinfectant. (The concentration and residence time specified in the table

are under the conditions where the service life of the parts is tested with each disinfectant used as described in its instruction manual. Please note that the testing was not performed for the purpose of ensuring the effectiveness of the disinfectants. There is no intention of suggesting that such disinfectants be used. Conditions of use and ingredients of disinfectant vary for manufacturers. Please read the instruction manuals carefully before use and apply disinfectant to each part in an appropriate way. Please notice that service life of the parts may be shorter

depending on conditions, environments and frequency of use.)

Removing condensation from the air tube

If there is moisture or liquid remaining in the air tube, be sure to follow the procedure below to remove any moisture from within the air tube.

1) Make sure that the air tube is connected to the air connector on the compressor.

2) Remove the air tube from the nebulizer kit.

3) Turn on the compressor and pump air through the air tube to expel the moisture.

Changing the air filter

If the air filter has been used for more than 60 days, replace it with a new one.

Pull the air filter cover off the compressor.

Change the air filter.

Put the air filter cover back in place. Make sure it is attached properly.

Notes:

• Use only OMRON air filters designed for this device. Do not operate without air filter.

• Do not wash or clean the air filter. If the air filter becomes wet, replace it. Damp air filters can cause blockages.

• There is no front or back orientation for the air filters.

• Check that air filters are clean and free of dust before inserting them.

Troubleshooting

Check the following if the device should fail during operation.

Problem Cause Remedy

Nothing happens when the power switch is pressed.

Is the AC adapter connected correctly to a power outlet and the compressor?

Check that the AC adapter is connected to a power outlet and the compressor. Unplug then reinsert the plug if necessary.

No nebulization or low nebulization rate, when the power is on.

Is there medication in the medication tank?

Add the correct amount of medication to the medication tank.

Is there too much/little medication in the medication tank?

Is the vaporizer head missing or not assembled correctly?

Attach the vaporizer head correctly.

Is the nebulizer kit assembled correctly?

Assemble the nebulizer kit correctly.

Is the nozzle blocked? Make sure that the nozzle is free of

blockages.

Is the nebulizer kit tilted at a sharp angle?

Make sure that the nebulizer kit is not tilted at an angle of more than 45 degrees.

Is the air tube connected correctly?

Make sure that the air tube is correctly connected to the compressor and nebulizer kit.

Is the air tube folded? Make sure that the air tube is not twisted or

bended.

Is the air tube blocked? Make sure that the air tube is free of

blockages.

Is the air filter dirty? Replace the air filter with a new one.

The compressor is abnormally loud.

Is the air filter cover attached correctly?

Attach the air filter cover correctly.

The compressor is very hot.

Is the compressor being covered?

Do not cover the compressor during operation.

Note: If the suggested remedy does not solve the problem, do not try to repair the

device - the device are not user serviceable. Return the device to an authorized OMRON retail outlet or distributor.

Technical data

Product Description: Compressor Nebulizer Model (-Code): NE-C803 (NE-C803-E) Rating (AC adapter): 100 - 240V ~ 50/60Hz 0.12 - 0.065A Rating (Compressor Nebulizer): 6V

0.7A

Operating Temperature / Humidity: +10°C to +40°C / 30% to 85%RH Storage and Transport

Temperature / Humidity / Air Pressure:

-20°C to +60°C / 10% to 95%RH / 700 - 1060hPa

Weight: Approx. 180g (compressor only) Dimensions: Approx. 85 (W) × 43 (H) ×115 (D) mm (compressor only) Contents: Compressor, Nebulizer Kit, Air Tube (PVC, 100cm),

Mouthpiece, Nosepiece, Adult Mask (PVC), Child Mask (PVC), 5 pcs Spare Air Filters, AC Adapter, Storage Bag, Instruction Manual.

Classifications: Class ll (Protection against electric shock),

Type BF (Applied part) IP21 (Ingress Protection)

= Class ll equipment

= Type BF

applied part

Read the instruction

manual carefully

= No operation

= Power on

Notes:

• Subject to technical modification without prior notice.

• This OMRON product is produced under the strict quality system of OMRON HEALTHCARE Co., Ltd., Japan.

• 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.

• See website of OMRON HEALTHCARE EUROPE to update technical information. URL: www.omron-healthcare.com

Technical data for the OMRON NE-C803 Compressor with the Nebulizer kit:

Particle Size: **MMAD Approx. 3μm

MMAD = Mass Median Aerodynamic Diameter

Medication Tank Capacity: 10ml maximum Appropriate Medication Quantities: 2ml minimum - 10ml maximum Sound: *Less than 45dB Nebulization Rate: *Approx. 0.30ml/min (by weight loss) Aerosol Output: ** 0.37ml (2ml, 1%NaF) Aerosol Output Rate: ** 0.05ml/min (2ml, 1%NaF)

Result of cascade impactor measurements for particle size**

100

0.1 1 10 100

Cumulative % particle mass of sodium fluoride under size

Particle Size Dp (μm)

Cumulative Undersize %

Mean

Individual

* Measured by OMRON HEALTHCARE Co., Ltd. Measured with saline at ambient

temperature of 23°C and humidity of 40%. It may vary with the type of medication.

** Independently measured by Prof. Dr. Hiroshi Takano, Therapeutic Systems Research

Center, Doshisha University, Kyoto, Japan, according to EN13544-1:2007+A1:2009.

Note:

Performance may vary with medication such as suspensions or high viscosity. See medication supplier’s data sheet for further details.

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.

Guarantee

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 a high level of comfort, 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 covers only products purchased in Europe, Russia and other CIS countries, Middle East and Africa.

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 accessories 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, visit our website (www.omron-healthcare.com) for contact 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 / cashticket issued to the consumer by the retailer. OMRON reserves the right to refuse the guarantee service if any unclear information has been given.

Manufacturer

OMRON HEALTHCARE Co., Ltd.

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

Production facility

OMRON HEALTHCARE MANUFACTURING VIETNAM CO., LTD.

No.28 VSIP II, Street 2, Vietnam-Singapore Industrial Park II, Binh Duong Industry-Services-Urban Complex, Hoa Phu Ward, Thu Dau Mot City, Binh Duong Province, Vietnam

Subsidiaries

OMRON HEALTHCARE UK LTD.

Opal Drive, Fox Milne, Milton Keynes, MK15 0DG, UK www.omron-healthcare.co.uk

OMRON MEDIZINTECHNIK HANDELSGESELLSCHAFT mbH

Gottlieb-Daimler-Strasse 10, 68165 Mannheim, GERMANY www.omron-healthcare.de

OMRON SANTÉ FRANCE SAS

14, rue de Lisbonne, 93561 Rosny-sous-Bois Cedex, FRANCE www.omron-healthcare.fr

Made in Vietnam

NE-C803-E_A_M09_140715.pdf

Nébuliseur à compresseur

NE-C803 (NE-C803-E)

Mode d’emploi

Introduction

Merci d’avoir acheté le système OMRON COMP AIR basic. Ce produit a été développé en collaboration avec des spécialistes du traitement de l’asthme, de la bronchite chronique, des allergies et autres troubles respiratoires. Ce produit est un appareil médical. Utilisez l’appareil selon les instructions de votre médecin et/ou du thérapeute.

Fonctionnement du kit de nébulisation

Le médicament, qui est pompé par le canal de médicament, est mélangé à l’air comprimé généré par une pompe du compresseur. Le médicament est transformé en fines particules et vaporisé lorsqu’il entre en contact avec l’air comprimé.

Aérosol

Canule

Air comprimé

Canal du médicament

Médicament

Avant d’utiliser l’appareil

Table des matières

Avant d’utiliser l’appareil

Introduction ............................................................................................................... 24

Utilisation prévue ...................................................................................................... 25

Instructions de sécurité importantes ......................................................................... 26

Familiarisation avec l’appareil................................................................................... 29

Accessoires médicaux en option .............................................................................. 30

Autres pièces en option/de rechange ....................................................................... 30

Instructions de fonctionnement

Utilisation .................................................................................................................. 31

Entretien et maintenance

Nettoyage et désinfection ......................................................................................... 35

Élimination de la condensation du tube à air ............................................................ 38

Changement du filtre à air ........................................................................................ 38

Dépannage ............................................................................................................... 39

Données techniques ................................................................................................. 40

Garantie .................................................................................................................... 43

Utilisation prévue

Objectif médical

Ce produit est destiné à être utilisé pour inhaler le médicament prescrit pour le traitement des troubles respiratoires.

Utilisateur visé

• Personnel médical (médecin, infirmière ou thérapeute).

• Soignant ou patient sous la directive de personnel médical qualifié pour traitement

à domicile.

• L’utilisateur doit également être en mesure de comprendre le fonctionnement général

du NE-C803, ainsi que le contenu de ce mode d’emploi.

Patients visés

Ce produit ne doit pas être utilisé sur des patients non conscients ou ne respirant pas spontanément.

Environnement

Ce produit est destiné à être utilisé dans un établissement médical (hôpital, clinique et cabinet médical) ou dans une maison.

Durée de conservation

Les durées de conservation sont les suivantes, sous réserve que le produit soit utilisé pour nébuliser 2 ml de médicament deux fois par jour pendant 7,5 minutes à chaque utilisation à température ambiante (23 °C). La durée de conservation peut varier selon l’environnement d’utilisation.

L’utilisation fréquente du produit peut réduire la durée de conservation. Compresseur (unité principale) 5 ans Kit de nébulisation 1 an Embout buccal 1 an Embout nasal 1 an Tube à air (PVC, 100 cm) 1 an Filtre à air 60 jours Masque (PVC) (SEBS) 1 an

Précautions d’utilisation

Les avertissements et les mises en garde décrits dans le mode d’emploi doivent être respectés.

Instructions de sécurité importantes

Lisez attentivement toutes les informations contenues dans le mode d’emploi et dans la documentation incluse dans l’emballage avant d’utiliser l’appareil.

Avertissement :

indique une situation potentiellement dangereuse qui, si elle n’est pas évitée, peut entraîner de graves lésions.

(Utilisation)

• Suivez les instructions de votre médecin ou du personnel soignant pour la nature du médicament, son dosage et sa posologie.

• En cas de sensations inhabituelles pendant l’utilisation, arrêtez immédiatement d’utiliser l’appareil et consultez votre médecin.

• N’utilisez pas de l’eau seule dans le nébuliseur pour l’inhalation.

• Gardez l’appareil hors de portée des nourrissons et des enfants laissés sans surveillance. L’appareil est susceptible de contenir de petites pièces pouvant être avalées.

• Ne rangez pas le tube à air si de l’humidité ou du médicament est resté à l’intérieur.

• N’utilisez ni ne conservez l’appareil dans des endroits où il risquerait d’être exposé à des émanations nocives ou à des substances volatiles.

• N’utilisez pas l’appareil dans des endroits où il risquerait d’être exposé à des gaz inflammables.

• Ne couvrez pas le compresseur avec une couverture, une serviette ou quoi que ce soit d’autre pendant l’utilisation.

• Mettez toujours au rebut tout reste de médicament après utilisation et utilisez une nouvelle dose de médicament à chaque fois.

• Ne l’utilisez pas dans les circuits anesthésiques ou dans les circuits de respiration du ventilateur.

• Conservez les composants dans un endroit propre pour éviter tout risque d’infection.

(Risque de choc électrique)

• Ne branchez ou ne débranchez jamais l’adaptateur secteur avec les mains mouillées.

• Le compresseur et l’adaptateur secteur ne sont pas étanches. Ne renversez pas de l’eau ou d’autres liquides sur ces composants. Si un liquide est renversé sur ces composants, débranchez immédiatement l’adaptateur secteur

et essuyez le liquide avec une compresse de gaze ou un autre tissu absorbant.

• N’immergez pas le compresseur dans de l’eau ou dans un autre liquide.

• N’utilisez pas et ne rangez pas l’appareil dans un endroit humide.

• Ne faites pas fonctionner l’appareil lorsque le cordon ou la fiche d’alimentation est endommagé.

• Maintenez le cordon d’alimentation éloigné des surfaces chauffées.

• Utilisez uniquement l’adaptateur secteur OMRON d’origine. L’utilisation d’un adaptateur secteur non pris en charge risque d’endommager l’appareil.

(Nettoyage et désinfection)

Observez les règles ci-dessous lors du nettoyage ou de la désinfection des composants. Le non-respect de ces règles peut occasionner des dommages, rendre la nébulisation inefficace ou entraîner une infection. Pour prendre connaissance des instructions, consultez la section « Nettoyage et désinfection ».

• Nettoyez et désinfectez le kit de nébulisation, le masque, l’embout buccal ou l’embout nasal avant utilisation dans les cas suivants :

- à la première utilisation après l’achat ;

- si l’appareil n’a pas été utilisé pendant une longue période ;

- si plusieurs personnes utilisent le même appareil.

• Veillez à laver ou à essuyer les composants après l’utilisation et assurez-vous qu’ils sont minutieusement désinfectés et séchés, et conservés dans un endroit propre.

• Ne laissez pas la solution de nettoyage dans les composants.

Attention :

Indique une situation potentiellement dangereuse qui, si elle n’est pas évitée, peut entraîner des blessures mineures ou modérées, ou des dommages physiques.

(Utilisation)

• Il faut être très vigilant lorsque cet appareil est utilisé par, sur ou à proximité d’enfants ou de

personnes infirmes.

• Vérifiez que les composants sont correctement fixés.

• Vérifiez que le filtre à air est correctement fixé.

• Assurez-vous que le filtre à air est propre. Si le filtre à air a été utilisé pendant plus de 60 jours,

remplacez-le par un filtre neuf.

• N’inclinez pas le kit de nébulisation à un angle supérieur à 45 degrés dans tous les sens et ne le secouez

pas pendant qu’il est en fonctionnement.

• N’utilisez pas et ne rangez pas l’appareil alors que le tube à air est plié.

• Utilisez uniquement des composants de nébulisation, un tube à air, un filtre à air et un couvercle de filtre

à air d’origine.

• N’ajoutez pas plus de 10 ml de médicament dans le réservoir de médicaments.

• Ne transportez pas et ne retirez pas le kit de nébulisation lorsque le réservoir de médicaments contient

un médicament.

• Ne laissez pas l’appareil sans surveillance en présence de jeunes enfants ou de personnes ne pouvant

pas exprimer leur consentement.

• Ne soumettez pas l’appareil à des chocs excessifs, par exemple en le faisant tomber sur le sol.

• Ne percez pas la canule du réservoir de médicaments avec une épingle ou un objet pointu.

• N’introduisez pas les doigts ou des objets à l’intérieur du compresseur.

• Ne démontez ni ne tentez de réparer le compresseur ou l’adaptateur secteur.

• Ne laissez pas l’appareil dans un endroit soumis à des températures chaudes ou froides extrêmes

ou sous la lumière directe du soleil.

• N’utilisez jamais l’appareil pendant que vous dormez ou somnolez.

• Autorisé pour un usage humain uniquement.

• Le compresseur peut devenir chaud pendant son fonctionnement.

• Ne touchez pas le compresseur, excepté lorsque cela est nécessaire, par exemple pour éteindre

l’appareil pendant la nébulisation.

• Pour éviter que du médicament ne reste sur le visage, essuyez-vous le visage après avoir retiré le

masque.

• Pour ne pas provoquer de lésions au niveau des muqueuses du nez, ne pressez pas l’embout nasal

dans l’arrière-nez.

• N’utilisez pas un kit de nébulisation, un embout buccal ou un embout nasal endommagé.

(Risque de choc électrique)

• Débranchez toujours l’adaptateur secteur de la prise de courant après utilisation et avant nettoyage.

• Branchez l’appareil sur la prise de la tension appropriée. Ne surchargez pas les prises d’alimentation

et n’utilisez pas de rallonges.

• N’utilisez pas le cordon d’alimentation de l’adaptateur secteur de manière incorrecte.

• N’enroulez pas le cordon d’alimentation autour du compresseur ou de l’adaptateur secteur.

• Ne tirez pas sur le cordon d’alimentation de l’adaptateur secteur.

• Tous les changements ou toutes les modifications n’ayant pas été approuvés par OMRON

HEALTHCARE annuleront la garantie de l’utilisateur.

• Débranchez toujours l’adaptateur secteur de l’appareil après utilisation et avant le nettoyage.

(Nettoyage et désinfection)

• N’utilisez pas de four à micro-ondes, de séchoir à vaisselle ou de sèche-cheveux pour sécher l’appareil ou les composants.

• N’utilisez pas d’appareil de stérilisation par autoclave, par oxyde d’éthylène ou par plasma basse température.

• Lorsque vous désinfectez des composants par ébullition, assurez-vous que le conteneur ne soit pas chauffé à sec. Cela pourrait provoquer un incendie.

Précautions de sécurité générales :

• Examinez l’appareil avant chaque utilisation et assurez-vous qu’il ne présente aucune anomalie. Vérifiez tout particulièrement les points suivants :

- La canule et le tuyau à air ne doivent pas être endommagés.

- La canule ne doit pas être bouchée.

- Le compresseur doit fonctionner normalement.

• La pompe du compresseur émet des bruits et des vibrations lorsque cet appareil est utilisé. L’émission d’air comprimé provenant du kit de nébulisation engendre également du bruit. Ceci est normal et n’est pas le signe d’un dysfonctionnement.

• Utilisez l’appareil uniquement aux fins attendues. Ne l’utilisez pas pour un usage différent.

• N’utilisez pas l’appareil à des températures supérieures à +40 °C.

• Vérifiez que le tube à air est bien fixé au compresseur et au kit de nébulisation et qu’il ne se détache pas.

• Afin d’isoler totalement l’appareil de la source d’alimentation, débranchez la fiche de la source d’alimentation.

Gardez soigneusement ces instructions pour vous y référer ultérieurement.

Familiarisation avec l’appareil

Adaptateur secteur x 1 Étui de rangement x 1 Mode d’emploi

Vue arrière

Connecteur d’alimentation

Couvercle de filtre à air *Filtre à air à l’intérieur

Compresseur (unité principale) x 1

Support du kit de nébulisation

Connecteur du tuyau à air

Interrupteur

Filtres à air de rechange x 5

Tube à air (PVC, 100 cm) x 1

Embout buccal x 1

Masque pour enfant (PVC) x 1

Masque pour adulte (PVC) x 1

Kit de nébulisation x 1

Connecteur du tuyau à air

Partie supérieure du système d’inhalation

Tête du vaporisateur

Canule

Réservoir de médicaments

Embout nasal x 1

Accessoires médicaux en option

(dans le cadre de la Directive européenne 93/42/CEE relative aux dispositifs médicaux)

Description du produit Modèle

Ensemble du kit de nébulisation et de l’embout buccal NEB-NSET3-83E Ensemble du kit de nébulisation, du masque pour adulte (PVC)

et du tuyau à air

NEB-NSET4-83AP

Ensemble du kit de nébulisation, du masque pour enfant (PVC) et du tuyau à air

NEB-NSET5-83AP

Masque pour adulte (PVC) NEB-MSLP-E Masque pour enfant (PVC) NEB-MSMP-E Masque pour adulte (SEBS) NEB-MSLS-E Ensemble du masque pour enfant (SEBS) NEB-MSSS-E Embout buccal NEB-MP-E Embout nasal NEB-NP-E Tuyau à air (PVC, 100 cm) NEB-TP-82E Adaptateur secteur HHP-CF01

Autres pièces en option/de rechange

Description du produit Modèle

Filtres à air x 5 NEB-AFR-30E

+ 168 hidden pages

Omron NE-C803, NE-C803-E Instruction Manual

Specifications and Main Features

Frequently Asked Questions

User Manual