Omron C 802 - CompAIR Basic Bedienungsanleitung

Omron Diversen C 802 - CompAIR Basic

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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-C802 and the content of instruction manual.

Intended Patients

This product should not be used by 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 8 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

Adult Mask (PVC) 1 year

Child Mask (PVC) 1 year

Precautions for use

Warnings and cautions described in the instruction manual should be

observed.

Know your unit

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.

• Clean and disinfect the nebulizer kit, mask, mouthpiece or nosepiece before using

them for the first time after purchase.

• If the device has not been used for a long period of time, or if more than one person

uses the same device, clean and disinfect the nebulizer kit, mask, mouthpiece or

nosepiece before using them.

• Be sure to wash the parts after use, and ensure that they are thoroughly disinfected

and dried, and stored in a clean location.

• Keep the device out of the 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 leave the cleaning solution in the nebulizer parts. Rinse them with clean hot

tap water after disinfecting.

• 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.

(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.

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 changed colour, or has been

used on average 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.

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

• Do not use the device while sleeping or if drowsy.

• Do not use a microwave oven, dish dryer or hair dryer to dry the device.

• 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 an autoclave, EOG gas disinfection or low temperature plasma sterilizer

to disinfect the device.

• 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.

Optional Medical Accessories

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

Name Model Order No.

Nebulizer Kit &

Mouthpiece Set NEB-NSET3-82E 9065690-7

Adult Mask (PVC) NEB-MSLP-E 9956275-1

Child Mask (PVC) NEB-MSMP-E 9956276-0

Adult Mask (SEBS) NEB-MSLS-E 9956312-0

Child Mask (SEBS) Set NEB-MSSS-E 9956281-6

Mouthpiece NEB-MP-E 9956273-5

Nosepiece NEB-NP-E 9956274-3

Air Tube (PVC, 100cm) NEB-TP-82E 9065693-1

AC Adapter NEB-AC-82E

(6V06ASW-E) 9065656-7

Other Optional/Replacement Parts

Name Model Order No.

Air Filters x 5 NEB-AFR-30E 9956636-6

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.

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 (DALIAN) CO., LTD.

Dalian, CHINA

Subsidiary

OMRON HEALTHCARE UK LTD.

Opal Drive, Fox Milne, Milton Keynes, MK15 0DG, U.K.

OMRON MEDIZINTECHNIK HANDELSGESELLSCHAFT mbH

John-Deere-Str. 81a, 68163 Mannheim, GERMANY

www.omron-medizintechnik.de

OMRON SANTÉ FRANCE SAS

14, rue de Lisbonne, 93561 Rosny-sous-Bois Cedex, FRANCE

Made in China

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.

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.

NE-C802-E_A_M06_120420.pdf

12G1781

Bottom view

Power Connector

Air Filter Cover

*Air filter inside

Compressor Nebulizer

Instruction Manual

Compressor (Main Unit) x 1

Nebulizer Kit x 1 Nosepiece x 1Mouthpiece x 1

Adult Mask (PVC) x 1 Child Mask (PVC) x 1

Air Tube

(PVC, 100cm) x 1

AC Adapter x 1

Storage Bag x 1

Instruction Manual

Warranty Card

Spare Air Filters x 5

IM-NE-C802-E-02-08/2012

1675453-0B

Medication

Aerosol

Nozzle

Medication Channel

Compressed Air

Nebulizer Kit Holder

Air Tube Connector

Power Switch

Medication Tank

Air Tube

Connector

Accessory Adapter

Inhalation Top

Vaporizer Head

Nozzle

NE-C802-E_A_M EN.indd 1NE-C802-E_A_M EN.indd 1 23/08/2012 12:12:2123/08/2012 12:12:21

Technical data

Product Description: Compressor Nebulizer

Model: NE-C802 (NE-C802-E)

Rating (AC adapter): 100-240V ~ 50/60Hz 15VA

Rating (Compressor

Nebulizer):

6V 0.6A

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. 190g (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, Warranty Card.

Classification: Class ll equipment, Type BF applied part

= Class ll

equipment

= Type BF

applied part

Read the instruction

manual carefully

= No operation = Power on

Technical data for the OMRON NE-C802 Compressor with the Nebulizer kit:

Particle Size: **MMAD Approx. 3m

MMAD = Mass Median Aerodynamic Diameter

Medication Tank Capacity: 10ml maximum

Appropriate Medication

Quantities:

2ml minimum - 10ml maximum

Sound: *Less than 45dB

Nebulization Rate: *Approx. 0.25ml/min (by weight loss)

Aerosol Output: **0.56ml (2ml, 1%NaF)

Aerosol Output Rate: **0.07ml/min (2ml, 1%NaF)

Result of cascade impactor measurements for particle size**

100

1 10 1000.1

Cumulative % particle mass of sodium fluoride undersize

Cumulative Undersize%

Particle Size (m)

Individual

Mean

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, Department of Chemical

Engineering and Materials Science, Faculty of Science and Engineering, Doshisha

University, Kyoto, Japan, according to EN 13544-1:2007+A1:2009.

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.

• Performance may vary with drugs such as suspensions or high viscosity. See drug

supplier’s data sheet for further details.

• See website of OMRON HEALTHCARE EUROPE to update technical information.

URL: www.omron-healthcare.com

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 changed colour, or has been used on average for more

than 60 days, replace it with a new one.

1. Pull the air filter cover off the compressor.

2. Change the air filter.

3. Put the air filter cover back in place.

Notes:

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

• Do not attempt to 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.

• Do not boil the air filter cover.

Cleaning and disinfecting

Cleaning

Clean the parts after each use to remove residual medication. This will avoid

inefficient nebulization or infection.

Firstly, make sure that the power plug unplugged from the power outlet.

■ Nebulizer Kit (Inhalation top, Accessory Adapter, Medication tank),

Mask (PVC), Mouthpiece, Nosepiece

Wash them in warm water and mild detergent. Rinse them thoroughly with

clean hot tap water and allow to air dry in a clean place.

Note: Nebulizer kit should be replaced after using for one year. Replace ONLY with

nebulizer kit designed for NE-C802.

■ Compressor, Air Tube

Wipe clean with a soft cloth moistened with water or mild detergent.

■ Vaporizer Head

Wash it with running water.

Disinfecting

Disinfect the parts once a week. If the parts are heavily stained, replace

them with new ones.

Use one of the following methods:

To select the method, refer to the table below.

A. Use a commercially available disinfectant. Follow the instructions

provided by the disinfectant manufacturer.

1) Submerge the parts in the disinfectant for the specified period.

2) Rinse them with clean hot tap water and allow to air dry in a clean place.

Note: Never clean with benzene, thinner or a flammable chemical.

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.

Note: Do not boil Air tube, Mask (PVC), Air filter and Air filter

cover.

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.

Use the table below as a guideline to select a method for disinfecting.

O: applicable ×: not applicable

Parts

Mouthpiece

Nosepiece

Nebulizer Kit

Air Filter

Air Filter Cover

Adult Mask (PVC)

Child Mask (PVC)

Air Tube

(PVC, 100cm)

Adult Mask (SEBS)

(optional)

Child Mask (SEBS)

(optional)

Materials

(Vaporizer Head: PC)

Polyester

ABS

Mask: PVC

(Phthalate free)

Band: Rubber

(non-latex)

PVC

(Phthalate free)

Mask: SEBS

Band: Rubber

(non-latex)

Adapter: PP

Boiling O O O × × × × O

Alcohol

OOO×O O × O

Disinfecting

ethanol

Sodium

hypochlorite

OOO×O O × O

Milton*

(0.1%)

Quaternary

ammonium

OOO×O O × O

Osvan*

(0.1%)

Chlorhexidine

OOO×O O × O

Hibitane*

(0.5%)

Amphoteric

Surfactant

OOO×O O × O

Tego*

(0.2%)

* an example of commercially available disinfectant.

How to use

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

2. Connect the AC adapter to the compressor and plug the power plug into

a power outlet.

3. Remove the inhalation top together with

the accessory adapter and vaporizer

head from the medication tank.

4. Add the correct amount of prescribed

medication to the medication tank.

Reattach the vaporizer head to the

medication tank.

5. Put the inhalation top and accessory

adapter back inside the medication tank.

6. Attach the mask, mouthpiece or

nosepiece to the nebulizer kit tightly.

Note:

Make sure an arrow mark on the nebulizer

kit is facing toward the patient. Otherwise,

medication may be sprayed on patient’s skin

or clothes.

7. Attach the air tube.

Push the air tube plugs firmly

into the air tube connectors.

8. 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.

9. Press the power switch to the on ( ) position. As the compressor

starts, nebulization begins and aerosol is generated.

Inhale the medication.

10. 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.

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 or

damaged?

Make sure that the air tube does

not contain kinks.

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 covered?

Do not cover the compressor with

any type of cover during use.

Note:

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

- no parts of the device are user serviceable. Return the device to an authorized

OMRON retail outlet or distributor.

Clicks

Arrow

Right angle

45°45°

Compressor

Power plug

NE-C802-E_A_M EN.indd 2NE-C802-E_A_M EN.indd 2 23/08/2012 12:12:2423/08/2012 12:12:24

Produktspezifikationen

Marke:	Omron
Kategorie:	Diversen
Modell:	C 802 - CompAIR Basic

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