Bedienungsanleitung Rossmax NK1000 3 in 1 (Seite 2 von 8) (Englisch)

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Introduction

Thank you for purchasing the unique 3in1 Compressor Nebulizer NK1000 which integrates with a

nebulizer kit, a nasal washer, and a nasal aspirator.

This product is developed in conjunction with respiratory therapists for the eective treatments

of asthma, COPD, chronic bronchitis, nasal and/or sinus congestion/stuness/ allergic symptoms

and other respiratory ailments. Treatments are delivered quickly, safely and conveniently making

this unit ideal for all ages in health care structures like hospitals and home care. Your compressor

nebulizer should be used under the supervision of a licensed physician and/or a respiratory

therapist. Together with your physician and/or respiratory therapist, you can feel comfortable

and condent knowing that you are obtaining the most eective inhalation and nasal aspiration

treatments for your respiratory condition.

NOTE: This is a medical device. Operate the device only as instructed by your doctor and/or

respiratory therapist. Please consult with your physician and/or pharmacist to determine if your

prescription medication is approved for use with this nebulizer. For type, dose and regime of

medication follow the instructions of your doctor or respiratory therapist.

Please read this manual carefully before use and be sure to keep this manual.

How the nebulizer kit works

Valve Adjustable Technology

The proprietary adjustable valve is able to deliver medications of

dierent viscosity level according to every user’s conditions and

needs at ease. Our VA technology allows users to adjust dierent

levels of nebulization rate ranging ≥ 0.1 – 0.3 ml/min at consistent

particle size.

The nebulization rates can be adjusted by the user in a very easy

way without exchanging parts. Higher nebulization rate/fully open

is for higher viscosity medications and higher breathing capacity

user while lower nebulization rate with closed valve will be more

appropriate for kids / infants with lower breathing capacity.

How the nasal washer works

Nasal washer connected to 3 in 1 compressor nebulizers, nebulizes an aqueous solutions for

ushing the nasal cavities by pressing the button on the ergonomic handle to activate the

nebulization and collects the return solutions. It can be used with saline solutions (isotonic and

hypertonic solutions, warm water) or medicated solutions for aerosol therapy. The body of nasal

washer has two adjacent chambers, inside one for holding the solution to be nebulized and the

outside for collecting the return solutions.

How the nasal aspirator works

The compressed air is generated by the suction pump which creates a vacuum sucking the mucus

into the collection chamber. Thanks to the Dual pump design, nebulization and suction pump,

provides the maximum hygiene to avoid cross infection and extends the life of the unit.

Preliminary Remarks

This device fulls the provision of the European Medical Device Directive 93/42/EEC amended

by 2007/47/EC and the European Standard EN 13544-1:2007+A1:2009 Respiratory therapy

equipment - Part 1: Nebulizing systems and their components.

Cautions

Please use general safety precautions when operating your nebulizer. This unit should be used

only for its intended purpose as described in this guidebook and with medications only under

the supervision and instruction of your physician. Do not use the device in anesthetic or ventilator

breathing circuits.

Product cautions

READ THE FOLLOWING BEFORE USING

• To avoid electrical shock: keep unit away from water.

• Do not immerse the unit in liquid.

• Do not use while bathing.

• Do not reach for a unit that has fallen into water immediately unplug the unit.

• Do not use the unit if it has any damaged parts (including plug), if it has been submersed in

water or dropped. Promptly send the unit for examination and repair.

• The unit should not be used where ammable gas, oxygen or aerosol spray products are being

used.

• Keep the air vents open. Do not place the unit on a soft surface where the openings can be

blocked.

• If any abnormality occurs, discontinue using until the unit has been examined and repaired.

• The unit should not be left unattended while plugged in.

• Do not tilt or shake the unit when in operation.

• Disconnect the unit from the electrical outlet before cleaning, lling and after each use.

• Do not use attachments unless recommended by the manufacturer.

• Do not plug or unplug the AC adapter into the electrical outlet with wet hands.

• Unplug the AC adapter from the electrical outlet after using the device.

• Do not disassemble or attempt to repair the unit.

• Do not use the device in anesthetic or ventilator breathing circuits.

• Use only original Rossmax accessories/parts as included in the product.

• Plug the device into the appropriate voltage outlet. Do not overload power outlets or use

extension power cords.

Operating cautions

• Microbial contamination: personal use of all parts is recommended in order to prevent any risks

of contagious infection.

• Before each use, inspect the device and all parts. If damaged or deteriorated, replace it at once.

• Close adult supervision is highly recommended when the unit is used by children or invalids.

• Keep your eyes away from the output of medication mist.

• Do not use this unit while operating a vehicle.

• If any discomfort or abnormality occurs, stop using the unit immediately.

• Do not use the device if the air tube is bent.

• Do not service or maintain device while in use.

• Do not use the tubing and/or AC adaptor for any other purpose than those specied, as they can

cause risk of strangulation.

• Manufacturer will not be held responsible for inappropriate use of the device.

• The correct functioning of the device may be aected by electromagnetic interference caused

by malfunctioning television sets, radios, etc. If this occurs, move the source of interference away

from the device or plug it into a dierent power socket.

• Do not insert any object into the compressor.

Storage cautions

• Do not store the unit in direct sunlight, high temperature or humidity.

• Always keep the unit unplugged while not in use.

• Some parts of the unit are small enough to be swallowed by children and can cause suocation;

keep the unit out of the reach of children.

• Store the device and parts in a clean location to avoid infection.

Cleaning cautions

• Check air lter, nebulizer, mouthpiece and any other optional component before each use. Dirty

or worn parts should be replaced.

• Do not immerse the unit in water. It may damage the unit.

• Disconnect the unit from the electrical outlet before cleaning.

• Clean all necessary parts after each use as instructed in this guidebook.

• Always dispose of any remaining medication in the medication cup after each use. Use fresh

medication each time you use the device.

• Do not store the air tube with moisture or medication remaining in the air tube. This could result

in infection as a result of bacteria.

• To prevent possible risk of infection from contaminated cleaning/disinfection solutions, always

prepare fresh solution for each cleaning cycle and discard solution after each use.

• Contaminated devices must be thoroughly sanitized prior to disinfection.

• Do not use gravity autoclave, EOG gas disinfection or low temperature plasma sterilizer to disinfect

the unit and parts.

• When disinfecting the unit by boiling, make sure to disassemble the parts and boil them with

plenty of water to completely immerse each individual part, taking care to avoid the parts directly

coming into contact with the bottom of the pot during the boiling.

• Carry out the cleaning procedures after every application for maximum hygiene to avoid cross

infection and extend the life of the unit.

• Do not use any hard object to clean and/or detach the unit in order to avoid any damage.

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

Nebulizer kit: Usage

• Pentamidine is not an approved medication for use with this device.

• If the medication cup is empty, do not attempt to operate the unit.

• The maximum capacity of the medication cup is 5 ml and should not be overlled.

• This product should not be used on patients, who are unconscious, sleeping, drowsy or are not

breathing spontaneously.

• To avoid medication residue on the face, be sure to clean the patient’s face after removing the

mask.

Nasal washer: Usage

• If the unit is used for therapeutic ushing, the administration of medication must be prescribed

or recommended by your physician, respecting the type of medication, doses and duration of

treatment indicated.

• Nasal washer should be used with a physiological saline solution. “Tap water” is not

recommended.

• Do not use the nasal washer with pneumatic device when taking a bath or shower.

• Do not add more than 20 ml of saline solutions to uid chamber.

• Do not insert any object into the nasal washer-tube connector.

Nasal aspirator: Usage

• The nasal aspirator should be used exclusively for removing the nasal mucus. It cannot be used for

any other purpose.

• Do not obstruct the openings on the bottom and/or the side of the nasal aspirator.

• If you notice rashes or redness appearing, inside or around the nose during or after using the unit

or anything unusual during use, stop using the unit and consult a physician.

• Do not attach the nasal aspirator to any other device.

MEDICAL DISCLAIMER:

This manual and product are not meant to be a substitute for advice provided by your doctor or

other medical professionals.

Don’t use the information contained herein or this product for diagnosing or treating a health

problem or prescribing any medication. If you have or suspect that you have a medical problem,

promptly consult your doctor.

Durable periods are as follows, provided the product is used to nebulize 2ml of medication 2 times

a day for 8 minutes each time, 15ml of saline solution 2 times a day for 5 minutes each time, and

aspirate 6 times a day for 3 minutes each time at room temperature (25°C).

Durable period may vary depending on usage and environment.

• Main unit 5 years

• Air Tube, Mouthpiece 1 year

• Nebulizer Kit 1 year

• Air Filter 60 days

• Nasal washer 1 year

• Adult and child masks 1 year

• Nasal aspirator 1 year

Product specications

AC Adaptor: DC12V, 1A

Power: AC100~240V, 50~60Hz

Power Consumption: ≤ 12 W

Sound Level: ≤ 60 dBA (1 meter away from NK1000 with Nebu-

lizer kit, Valve closed)

Compressor Pressure Range: ≥ 16 psi (110 kPa)

Operating Pressure Range: Nebulizer kit: ≥ 8 psi (55 kPa)

Nasal washer: ≥ 9 psi

Operating Vacuum Range: Nasal aspirator: ≤ -450mmHg

Operating Flow Range: Nebulizer kit: ≥ 3.0 lpm

Nasal washer: ≥ 4.2 lpm (for reference only)

Nasal aspirator: ≥ 5.0 lpm

Operating Temperature Range: 50ºF to 104ºF (10ºC to 40ºC)

Operating Humidity Range: ≤ 90% RH

Operating Atmospheric Pressure Range: 700-1060 hPa

Storage Temperature Range: -4ºF to 140ºF (-20ºC to 60ºC)

Storage Humidity Range: ≤ 90 % RH

Dimension (L x W x H): 260mmx170mmx120mm (10.24x6.69x4.72 inches)

Weight: 1540g (without accessories)

Medication Capacity: 5ml(cc) (Nebulizer kit)

Fluid chamber capacity: Max. 20 ml (c.c.) (Nasal washer)

Nasal adaptor with silicone tip size: L: 9mm, M: 7.6mm, S: 6.5mm (OD)

Particle Size (MMAD): ≤ 2.5μm (Nebulizer kit)

Average Nebulization Rate Fully open Valve: ≥ 0.3ml/min (Nebulizer kit) (0.9% Saline Solution)

Average Nebulization Rate Closed Valve: ≥0.1ml/min (Nebulizer kit) (0.9% Saline Solution)

Average Nebulization Rate: ≥ 3.0ml/min (Nebulizer washer) (0.9% Saline Solu-

tion)

Standard Accessories: Nebulizer Kit, Nasal Washer, Nasal Aspirator, Clear

Air Tube, Blue Air Tube, Mouthpiece, Filters (5pcs),

Adult and child masks, Filter (1pc)(Nasal Aspirator).

* Subject to technical modication without prior notice.

* Performance may vary with drugs such as suspensions or high viscosity, See drug supplier’s

data sheet for further details.

AProduct identication

1. Nebulizer Kit 2. Nasal Washer 3. Nasal Aspirator 4. Air Filter

5. AC Adaptor 6. Clear Air Tube 7. Blue Air Tube 8. Air Outlet

9. Vacuum regulator 10. Air Inlet 11. Power Switch 12. Air Filter Slot

13. AC Adaptor Jack

BUsing the AC Adapter

1. Check that the power switch is in the “OFF” position.

2. Connect the AC adapter with the AC adapter jack on the left side of the unit.

3. Plug the AC adapter into the socket. (AC adapters with required voltage and current indicated

near the AC adapter jack.)

4. Press the power-switch to the “ON” position.

C-2 Assembling your nebulizer kit

1. Gently twist and pull straight up on the lid of the nebulizer kit to separate into two parts

(medication cup and cover).

2. Make sure that the nozzle is properly installed on the upper cover. The stem inside the medication

cup inserts into the tube of the nozzle.

3. Add the prescribed amount of medication to the medication cup.

4. Reassemble the nebulizer kit by carefully twisting the medication cup and cover together. Make

sure that the two parts t securely.

5. Connect one end of the air tube in clear to the “AIR OUTLET” connector marked “Nebulizer”

on the left side of the compressor and the other end to the air tube connector at the base of

the nebulizer kit.

C-3 Operating your nebulizer kit

The nebulizer kit is operable at up to a 45° angle.

If the angle is greater than 45°, no aerosol will

be generated.

1. Attach the angled mouthpiece or mask to

the top of the nebulizer kit.

2. The capacity of the medication cup is 2~5

ml.

3. Place the power switch to the “Nebulizer”

(−) position.

4. When the compressor is acted on,

nebulization begins and aerosol is generated.

Inhale the medication and exhale through

the nebulizer kit.

DNasal washer

D-1 Product identication

1. Nasal adaptor with silicone tip (S/M/L) 2. Top cover 3. Separator 4. Nozzle

5. Fluid/ Nebulization chamber (Max. 20 ml/c.c.) 6. Return uid collection chamber

7. Ergonomic washer body 8. Air tube to the nebulizer

9. Nasal washer- tube connector 10. Trigger button

D-2 Assembling your nasal washer

1. Choose the most appropriate nasal adaptor with silicone tip (S/M/L) that ts the size of your

nostrils and insert it into the top cover.

2. Insert the nozzle into the center stem of the unit and make sure the nozzle is properly set in

place.

3. Pour the solution (10~15ml, max. 20 ml/c.c.) into the inside uid chamber. Always use fresh

solution each time you use the unit.

4. Put the separator and top cover back.

5. Connect one end of the air tube in clear to the “AIR OUTLET” connector marked “Washer” on

the left side of the compressor and the other end to the nasal washer- tube connector.

6. Make sure all parts are correctly inserted and connected to each other.

D-3 Operating your nasal washer

It is recommended to keep the nasal washer straight or operate at up to a 30° angle while in use.

If the angle is greater than 30°, the return uid from the nose may drip outside the unit.

1. Turn the power switch to the “Washer” (−) position.

2. Place the unit close to the nose and gently insert the nasal adaptor into one nostril.

3. During the application it is advisable to press your nger on the other nostril and keep it closed.

4. Start the nasal irrigator by holding down the trigger button while breathing in and release it

before breathing out. At this stage, to help expel the mucus, blow gently through the nostril

treated directly with the Nasal Washer.

5. Repeat above steps for the other nostril, trying to evenly distribute the solution between the

two nostrils. Interrupt the nebulization to blow your nose whenever necessary.

6. When used on children or disabled people, or in any case when there are problems in coordinating

the various steps as described 4, we recommend to run the application alternating the nostrils

about 20 seconds each, pausing in between to expel the mucus.

7. If the unit is used for therapeutic ushing, it is good idea to wash your nose with saline solution

before administering aerosol treatments. This will help to achieve a more eective distribution

of the medication over the nasal mucosa.

ENasal Aspirator

E-1 Product identication

1. Silicone tip 2. Silicone tube 3. Top cover 4. Finger opening

5. O-ring 6. Silicone tube 7. Collection chamber 8. Filter

E-2 Assembling your nasal aspirator

1. Insert the lter marked “IN” side to the air tube connector at the base of the nasal aspirator.

2. Make sure that the O-ring is properly attached.

3. Connect one end of the air tube in blue to the “AIR INLET” connector marked “Nasal

Aspirator” on the right side of the compressor and the other end to the air tube connector.

Make sure they are inserted rmly.

Instructions for use

Follow the cleaning instructions in this guidebook under “Cleaning procedures” prior to using your

nebulizer for the rst time or after it has been stored for an extended period of time.

Note: Always unplug the compressor and make sure the power switch is turned to the “OFF” (O)

position before cleaning, assembling and before or after each use.

Operating your nebulizer

Place the compressor on a at, stable surface within reach. Make sure that the power switch is in

the OFF (O) position before use.

After every use:

1. Unplug the unit from the power source.

2. Allow the unit to completely cool.

3. Carefully detach the air tube from the nebulizer and pour out any remaining medication.

4. Follow the cleaning procedures provided in this guidebook.

Note: A 30-minute interval is recommended after each use.

CNebulizer kit

C-1 Product identication

1. Nebulizer kit 2. Nozzle 3. Angled Mouthpiece 4. Child Mask 5.Adult Mask

Max. 5ml (c.c.)

12 3

AC Adapter

(Ø3.8/Ø1.35)

C-1 C-2

C-3

<30°

D-3

Max.

20ml

(c.c.)

D-2

D-1

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