Sano - Inhaler Neno - Free user manual and instructions

USER MANUAL Sano Neno

Medical device with a nasal cannula and tubing, no visible text or symbols on the device itself.

Table of contents

Spis treści

6 Instrukcja obsługi PL
14 User manual EN
19 Bedienungsanleitung DE
26 Návod k použití CZ
31 Használati utasítás HU
37 Používatel'ská príručka SK
43 Användarhandbok SE
49 Käyttäjän käsikirja FI
54 Brukerhåndbok NO
60 Brugermanual DK
65 Gebruikershandleiding NL
71 Manual del usuario ES
77 Manuale utente IT
83 Manuel de l'utilisateur FR
89 Manual de utilizare RO

A

! 2 3 4 5 IPX1 6 7 SN 8 LOT 9 EC REP 10 CE 11

B

Diagram showing eight labeled items of medical or laboratory equipment, including a cup, bottle, device, and tubing.

Technical diagram of a laboratory apparatus with numbered components and labeled parts

graph TD
    A["1: Pump with digital display"] --> B["2: Bag with lid"]
    B --> C["3: Gas receiving tube"]
    C --> D["4: Bag with filter"]
    D --> E["5: Dosage receiving tube"]

Two laboratory apparatus diagrams showing a connected device and a gas collection setup (no text or labels)

E

1

Line drawing of a person holding a phone to their ear (no text or symbols)

45° X

2

Line drawing of a person drinking from a glass (no text or symbols)

Line drawing of a person using a tool to measure their eye area (no text or symbols)

F

●

The image is too blurry to recognize any text content.

Line drawing of various household items including a glass, mallet, and kitchen utensils (no text or symbols)

4

Line drawing of a game controller with buttons and a central square (no text or symbols)

PL

INSTRUKCJA OBSŁUGI

NENO SANO

Dear customer, thank you for purchasing the Neno Sano compressor nebuliser.

PURPOSE OF THE PRODUCT

The device is a medical device created to be used with medicines prescribed or recommended by the doctor for the treatment of respiratory tract. The properties of the medication may affect the nebulisation process of the device. The nebulisation rate may also be reduced when the temperature of the medicine is low.

Before using the product, read the following instructions carefully.

01. PRECAUTIONS

1. Follow the doctor's instructions for the dosage and frequency of the treatment.

2. Clean and disinfect the medication cup, inhalation mask, mouthpiece after the first use of the device or after a prolonged period of non-use.

3. Clean and disinfect the medication cup, inhalation mask and mouthpiece after each use. Store the cleaned parts in a clean and dry place.

4. Make sure the medicine container is clean before use.

5. Keep the appliance out of the reach of infants and children without adult supervision. The device may contain small parts that can be swallowed; suffocation may occur.

6. Use only original parts and accessories included in the kit. Parts and accessories not approved for use with this unit do not meet the expected specification or may damage the unit.

7. Do not wash or immerse the nebuliser in water.

8. Do not cover the nebuliser with a blanket/towel/other cover during the operation of the device. This may lead to overheating, damage or malfunction of the equipment.

9. Do not use the device in areas where the unit may be exposed to flammable gas or fumes.

10. Always discard any leftover medication after each use.

11. Do not leave the device or its parts where it will be exposed to extreme temperatures or changes in humidity, such as leaving the unit in a car during warm or hot months or where it will be exposed to direct sunlight.

12. Do not use or store the unit where it may be exposed to harmful fumes or volatile substances.

13. Do not use the nebuliser or power the plug when it is wet.

14. Do not connect or disconnect the plug to an electrical outlet with wet hands.

15. Do not use or store the unit in damp areas such as the bathroom.

16. Do not use the device with a damaged power cord or plug.

17. The device must be used under close adult supervision.

18. Do not disassemble, repair or modify the unit. In case of problems, contact an authorised service centre.

19. Limit the use of device to 25 minutes at a time. The recommended cooldown period is 40 minutes.

20. Make sure the air filter is clean. If the air filter has changed colour or has been used for more than 60 days, replace it with a new one.

21. Ensure that the medicine container is correctly fitted, the air filter is correctly installed and the airpipe is properly connected to the compressor and the medicine tank. If the air tube is not connected correctly, air may leak out during use.

22. Do not use the unit if the air tube is bent or broken.

23. Do not add more than 8ml of medication to the medication container. Do not operate the device at temperatures higher than +40°C (+104*F).

24. Do not tilt the medication container so that the angle of the set is greater than 45^ . The medication may spill out.

25. Do not shake the medication container when using the device.

26. Do not use the device while sleeping or if you are drowsy.

02. NOTES

1. When using this device, there will be some noise and vibration caused by the compressor. This is specific to the device.
2. If the device is used continuously, its service life may be reduced.
3. Disconnect the power plug from the electrical outlet before cleaning the device. After use, do not leave the medicine container with any medication in it.
4. The device is not intended for use with oily substances.

03. SYMBOLS

The following symbols may be found in the user manual, on the packaging, on the device or on accessories. Some symbols represent standards and compatibilities relating to the device and its use.

SEE FIG. A

1. Symbol indicating precautions. There are specific warnings or precautions associated with the appliance that are not found on the label. This symbol can also mean „Caution, please see operating instructions”.
2. Manufacturer.
3. Disposal. Do not dispose of this product in the waste bin for mixed municipal waste. Take the device to a suitable disposal location according to your area's rules.
4. Follow the instructions for use.
5. BF parts used.
6. Waterproof class. Protection against water droplets.
7. Date of manufacture of the product.
8. Manufacturer's serial number.
9. Lot number.
10. Authorised representative.
11. Symbol denoting the CE mark. This symbol certifies that the product has met EU requirements.

04. CONTENTS OF THE KIT

SEE FIG. B

1. Nebuliser (main unit)
2. Drug container
3. Inhalation mask (for adults)
4. Inhalation mask (for children)
5. Mouthpiece
6. Air tube
7. Air filters
8. Power supply

05. PRODUCT DESCRIPTION

SEE FIG. C

1. Nebuliser (main unit)
2. Air tube
3. Air duct
4. Power switch
5. DC socket
6. Medication container (set)
7. Medicine container holder
8. Air filter cover
9. Pads
10. Power cable
11. Medicine container cover
12. Inner lid for medication
13. Connector
14. Medicine container

06. INSTALLATION

Make sure the mouthpiece/mask and air filter are clean before use.

• Clean and disinfect medicine container, mouthpiece, masks before first use.
• If the device has not been used for a long time or if more than one person uses the same device, clean and disinfect the container before use.

• Make sure the air filter is clean. If the air filter has changed colour or has been used for more than 60 days, replace it with a new one.

• Connect the power supply to the DC socket of the nebuliser and then to the power socket. SEE FIG. D. 1

• Remove the cover of the medication container. SEE FIG. D. 2
• Carefully lift the inner lid and fill the medication container with the correct amount of medication. SEE FIG. D. 3
• Fix the inner cover by gently turning it clockwise, then attach the cover. SEE FIG. D. 4
• Attach mouthpiece or mask. SEE FIG. D. 5
• Twist the air tube plug and push it firmly into the nebuliser air tube connector. Twist the air tube plug slightly and press it firmly into the air tube connector at the bottom of the medication cup. SEE FIG. D. 6

NOTE: Hold the medication container in an upright position when fitting the air tube. The nebuliser has a handle to hold the medication container vertically. SEE FIG. D. 7

07. INSTRUCTIONS FOR USE

1. Hold the medicine container as shown.
   Do not tilt the medicine container at an angle greater than 45^ . Otherwise, the medication may spill out. SEE FIG. E. 1

2. Switch on the nebuliser. Once the compressor starts, nebulisation will begin. Inhale the medication as directed by your doctor.

3. Mouthpiece: Place the mouthpiece in your mouth and inhale the medication.

4. Mask: Place mask over nose and mouth. Pull the elastic band over the head. Gently pull the strap so that the mask fits over the nose and mouth. Inhale the medication. SEE FIG. E. 2

5. When nebulisation is complete, switch off the device.

6. Disconnect the air tube from the medication container and nebuliser. Grasp the air tube plug and gently pull downwards. Check the air tube. No moisture should remain in the tube.

7. If any condensation or moisture remains in the air tube, follow the instructions below:

8. Ensure that the air tube is still connected to the connector on the compressor.

9. Switch on the unit. Air will be pumped through the tube to expel the moisture. After cleaning, switch off the unit.

10. Disconnect the air tube from the nebuliser.

11. Disconnect the DC power supply from the electrical socket.

08. CLEANING THE APPLIANCE

CLEANING THE MEDICINE CONTAINER:

1. Disassemble all components of the medication container. Disconnect the air tube.
2. Any remaining medication should be discarded.
3. Wash the parts in clean water.
4. Dry in a clean environment using a soft cloth. SEE FIG. F. 1, 2, 3
5. Once dry, fit the components of the medicine container.

NOTE: Clean the nebuliser with a soft cloth moistened with water or a mild detergent. Do not use strong cleaning agents.

DISINFECTION:

The mask/mouthpiece and the medication container should be disinfected after the last treatment of the day. Recommended disinfectant: 70% isopropanol solution or 75% ( ± 5%) medical alcohol.

NOTE: Do not dry parts in a microwave oven. Do not use an autoclave or plasma steriliser to disinfect the unit.

CLEANING THE AIR FILTER:

1. Gently pull the air filter cap to remove from the nebuliser. SEE FIG. F. 4

2. Remove the dirty air lter.

3. Insert a new air lter.
4. Re t the air lter cap.

NOTE: If the air lter has changed colour or has been used for more than 60 days, replace it with a new one.

Do not wash or clean the air lter. This may cause it to become blocked.

Do not use co on or other materials in place of the air liter. Make sure the air liter is clean before inser ng a new air liter.

Do not operate the unit without an air liter.

09. MAINTENANCE OF THE APPLIANCE

1. The device is a medical device. Follow your doctor's instructions and use the device correctly.
2. The characteris cs of nebulisa on performed by the device are variable depending on the proper es of the drug administered. Par cularly when drugs with high ac vity or viscosity are used, the nebulisa on rate may be reduced. The nebulisa on rate may also be reduced when the temperature of the drug is low.
3. Do not use the device if it is damaged in any way.
4. When not in use, the unit should be stored in a dry room and protected from extreme moisture, heat, dust and direct sunlight.
5. Close supervision must be provided when the appliance is used by or near children.
6. It is advisable to use an inhala on mask when the main device is used by a child under 5 years of age.
7. Keep the device out of the reach of babies and children without supervision. The mouthpiece or other small parts could be swallowed.
8. A er use, the device should be disconnected from the power source.
9. The mouthpiece and inhala on mask are in direct contact with the user and should be kept clean.

10. PROBLEM SOLVING

1. No power to the unit when the power switch is on:

Turn o the power switch. Check that the power supply is correctly connected.

1. No nebulisation or low nebulisation rate when power is switched on:

No or too much medicine in the medicine container.

Container parts are not ed correctly.

The air tube is twisted, damaged or incorrectly ed.

The medica on container is lted at the wrong angle.

The air lter is dirty.

1. The device heats up:

The con- nuous opera on should be at most 25 minutes long. Take a 40min break before using the device again.

1. The appliance operates too loudly:

The air tube is incorrectly installed.

The air lter cover is not properly secured.

11. ELECTROMAGNETIC COMPATIBILITY

1. This appliance must be installed and put into service in accordance with the information contained in the following instructions.
2. The range of tests for the basic safety and essen al performance of medical equipment and systems should be selected based on a high probability of maintaining basic safety and essen al performance and should be compa ble with the professional healthcare facility environment, the home healthcare environment and the specialty environment, based on the loca ons of intended use.
3. Home healthcare is the residence where the patients lives or other places where patients reside, excluding professional healthcare settings where medically trained operators are permanently available when patients are present. Such as schools, outdoor facilities, homes, hotels.
4. Please dispose of parts of the appliance at the end of its use in accordance with the rules in force at the location.

Deduction and generation of electromagnetic emissions

The NENO SANO Compressor Nebuliser (VP-D2) is designed for use in the electromagnetic environment described below; the customer or user of the nebuliser should ensure that it is used in such an environment.

Emissions testing Compatibility Electromagnetic environment - guidance
RF emissions CISPR 11 Group 1		The compressor nebuliser NENO SANO (VP-D2) uses RF energy only for its internal functions. Therefore, RF emissions are very low and do not cause interference to nearby electronic equipment.
RF emissions CISPR 11	Class B	The NENO SANO (VP-D2) compressor nebuliser is suitable for use in all non-domestic premises and those directly connected to the public low-voltage mains supplying buildings used for residential purposes.
Harmonic emission IEC 61000-3-2	Class A
Voltage fluctuations/flicker emissions IEC 61000-3-3	Compatibility	The NENO SANO (VP-D2) compressor nebuliser is suitable for use in all non-domestic premises and those directly connected to the public low-voltage mains supplying buildings used for residential purposes.

Guidelines and manufacturer's declaration - electromagnetic immunity

The NENO SANO Compressor Nebuliser (VP-D2) is intended for use in the electromagnetic environment specified below; the customer or user of the NENO SANO Compressor Nebuliser (VP-D2) should ensure that it is used in such an environment.

Immunity test IEC 60601test level		Level of compliance	Electromagnetic environment – guidance
Electrostatic Discharge (ESD)IEC6100CMU2	±8 kVcontact ±2kV, ±4 kV, ±8 kV, 15 kV air	±8 kVcontact ±2kV, ±4kV, ±8 kV, ±15 kV air	Floors should be wooden, concrete or ceramic tiles. If the floor is covered with a synthetic material, the humidity should be at least 30%.
Electrical fast transient/explosion IEC 6100044	±2KV for supply lines	±2KV for supply lines	The quality of the mains supply should be that of a typical or hospital environment.
IEC surges 61 OOM-5	±1 lead to wire, ±2 kV lead to ground	±1 kV wire to wire, ±12 kV wire to ground	The quality of the mains supply should be that of a typical commercial or hospital environment.
Power frequency (50/60Hz) magnetic field IEC 61000-4-8	30A/m 30A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
Voltage drops, short interruptions and voltage variations on supply linesIEC 610004-11	0% UT; 0.5 cycle at O°, 45°, 90°, 135°, 180°, 225°, 270° i 315°	0% UT; 0.5 cycle at 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315°	The quality of the mains power supply should be that of a typical commercial or hospital environment. If the user of the NENO SANO Compressor Nebuliser (VP-D2) requires continuous operation during power outages, it is recommended that the NENO SANO Compressor Nebuliser (VP-D2) is powered by an emergency power supply or battery.

12. SPECIFICATION

Power supply: AC 100V-240V, 50Hz/60Hz

Capacity of medication container: ≤8ml

Air tube length: 150cm

Number of masks: 1x for child; 1x for adult

Mouthpiece: yes

Aerosol capacity: ≥ 0.20 ml/min

MMAD (mean aerosol particle size): approx. 5um

Operating pressure range: 20kPa-80kPa (2.9psi-11.7psi)

Noise level: ≤ 52Db

Respirable fraction FR: ≥76%.

Spare air filter: yes, 2 pcs

Treatment time: 25min, 40min break

Storage temperature: -20 - 50°C

Storage atmospheric pressure: 700 - 1060hPa

Permissible humidity: 30 - 85% RH

Dead volume (residual): ≤0.7ml

Weight of nebuliser: 315g

Dimensions of nebuliser: 143x80x67mm

Weight and size of box: 0.63kg, 162x147x91mm

Warranty: 2 years door to door

Respirable fraction: 76%

Dead volume (residual): ≤0.7 ml

Operating time: 25min (recommended 40min break after one cycle)

13. GUARANTEE

The product comes with a 24-months warranty. Warranty terms and conditions can be found at:

https://neno.pl/gwarancja. Contact and service address can be found at: https://neno.pl/kontakt.

Specifications and kit contents are subject to change without notice. We apologise for any inconvenience.

KGK TREND declares that the Neno Sano device complies with the essential requirements of Directive

2014/53/EU. The full declaration can be found at the following link:

Date of last update of the instructions for use: 11.09.2023.

DE

BEDIENUNGSANLEITUNG

NENO SANO

04. INNEHÅLL I SATSEN

SE FIG. B

FORMÅLET MED PRODUKTET

04. INNHOLDET I SETTET

SE FIG. B

09. VEDLIKEHOLD AV APPARATET

FORMÅL MED PRODUKTET

04. INDHOLD AF SÆTTET

SE FIG. B

08. RENG∅RING AF APPARATET

RENG∅RING AF MEDICINBEHOLDEREN:

05. PRODUCTOMSCHRIJVING

ZIE FIG. C

10. PROBLEEMOPLOSSING

Fraction respirable FR: ≥76%.

Fraction respirable: 76%

KGK TREND Sp. z o.o.

(dawniej KGK Trade Sp. z o.o. Sp. K.)

ul. Ujastek 5b, 31-752 Kraków, Polska.

Wyprodukowano w PRC

www.neno.pl

Wytwórca/Manufacturer/Hersteller/Výrobce/Gyártó/Výrobca/Gamintojas/Ražotājs/Tootja/Producātor/Производител:

Vapo Healthcare Co., Ltd

Southern unit of third oor, building B,

No 99 Yudal West Rd, High tech district, KunShan, Suzhou Jiangsu Province, China

Autoryzowany przedstawiciel/Authorized representative/Bevollmächtigter Vertreter/Zplnomčený zástupce/ Meghatalmazott képviselő/Autorizovaný zástupca/Jgaliotasis atstovas/Pilnvarotais pärstāvis/ Volitatud esindaja/Producător/ Reprezentant autorizat/ Упълномощен представител:

Share Info GmbH

Her er Lohweg 83, 40549 Dusseldorf, Germany

0197