OMRON C101 Essential Compressor Nebulizer - Návod na používanie

Introduction

This document is the user manual for the OMRON C101 Essential compressor nebulizer.

Určenie (Intended Use)

Medicínsky účel (Medical Purpose)

This product is intended for the inhalation of medications for respiratory diseases. The compressor is designed for repeated use by multiple patients, while the inhalation set and its accessories are intended for single-patient repeated use.

Určený používateľ (Intended User)

• Healthcare professionals such as doctors, nurses, and therapists with official certifications.
• Caregivers or patients under the guidance of qualified healthcare professionals for home care.
• The user must also be able to understand the general principles of operation of the C101 Essential/X101 Easy inhaler and the content of this user manual.

Pacienti, ktorým je určený (Patients For Whom It Is Intended)

Individuals of any age who have respiratory diseases and require inhalation therapy.

Prostredie (Environment)

This product is intended for use in a typical household environment.

Dĺžka využiteľnosti (Lifespan)

If this product is used for inhalation 3 times a day, each for 10 minutes, at room temperature (23 °C), the lifespan is as follows. The lifespan depends on the environment in which the product is used and may differ.

• Compressor (main unit): 5 years
• Air tubing - Inhalation set - Mouthpiece - Adult mask - Child mask - Nasal aspirator - Adapter: 1 year; Air filter: 70 inhalations

Frequent use of this product may shorten its lifespan.

Oboznámte sa so zariadením (Familiarize Yourself with the Device)

Kompresor (hlavné zariadenie) (Compressor (Main Unit))

Components:

• Air tubing connection
• Power switch [power-off]
• Air filter cover with air filter
• Inhalator set holder
• Ventilation openings
• Power supply cord
• Plug
• Ventilation openings

Zostava inhalátora (Inhalator Set)

Components:

• Air tubing connection
• Inhalator top cover
• Vaporizer head
• Medicine cup
• Mouthpiece
• Nasal aspirator
• Adult mask (PVC)
• Child mask (PVC)
• Adapter
• Air tubing (PVC, 100 cm)

Princíp činnosti zostavy inhalátora (Principle of Operation of the Inhalator Set)

The medication supplied through the channel is mixed with compressed air generated by the compressor pump. The compressed air mixed with the medication is converted into fine particles that are sprayed when they come into contact with the nebulizer at the vaporizer head.

Diagram Description: Illustrates compressed air mixing with medication, passing through a nozzle, and being expelled as an aerosol spray.

Dôležité bezpečnostné pokyny (Important Safety Instructions)

Read the manual carefully before use.

Výstraha (Warning)

1. Use this device only as an inhaler for therapeutic purposes. Any other use is inappropriate and may be dangerous. The manufacturer is not responsible for misuse.
2. Do not use the device with anesthetics or artificial ventilation equipment.
3. Always unplug the power cord after use and before cleaning.
4. Do not cover the ventilation openings during use. The compressor may overheat and cause burns upon contact.
5. The compressor and power cord plug are not waterproof. Water or other liquids must not be spilled on these parts. If liquid is spilled on these parts, immediately unplug the power cord and wipe off the liquid.
6. Do not attempt to repair the device. Refer to the Troubleshooting section.
7. Store the device out of reach of unsupervised children. The device contains small parts that could be swallowed.
8. Use this device with increased caution for children and disabled persons.
9. Follow the instructions of your doctor or respiratory specialist regarding the type, dosage of medication, and regimen.
10. This product must not be used by unconscious patients or patients without spontaneous breathing.
11. After completing the treatment, remember to disconnect the air tubing from the inhalation set and from the compressor.
12. Due to their length, the power cord plug and air tubing may pose a strangulation hazard.
13. Ensure that the compressor is used in a location where the power cord plug is easily accessible during treatment.
14. If any allergic reactions or other difficulties occur during use, stop using the device immediately and consult your doctor.
15. When using this device, ensure that no mobile phones or electrical devices generating electromagnetic fields are located within 30 cm of it. Otherwise, the device's performance may be reduced.
16. The nebulizer set and its accessories are intended for single-patient use. Do not use with multiple patients. Use separate accessories for each patient.
17. Clean the components after each use and disinfect them once a week with normal use.

Postup (Procedure)

1. Ensure the power switch is in the off position [power-off] and the power cord plug is disconnected from the electrical outlet.
2. Remove the inhalator top cover from the medicine cup.
   1. Turn the inhalator top cover counterclockwise.
   2. Remove the inhalator top cover from the medicine cup.
3. Verify the presence of the vaporizer head in the medicine cup.
4. Add the correct amount of prescribed medication to the medicine cup.
5. Reattach the inhalator top cover to the medicine cup.
   1. Place the inhalator top cover onto the medicine cup.
   2. Turn the inhalator top cover clockwise.
6. Firmly attach the adapter and mask, mouthpiece, or nasal aspirator to the inhalation set.
7. Connect the air tubing. Firmly attach the end of the air tubing to the air tubing connection by gently twisting.
8. Hold the inhalation set as shown in the sketch. Follow the instructions of your doctor or respiratory specialist.

   Upozornenie (Caution): Do not tilt the inhalation set at an angle greater than 30 degrees in any direction. Medication could flow into the mouth, or it may lead to ineffective inhalation.

9. Insert the power cord plug into the electrical outlet.

   Poznámka (Note): Do not place the device in locations where disconnecting the power cord is difficult.

10. Turn the power switch to the on position [power-on]. When the compressor starts, nebulization begins and an aerosol is generated. Inhale the medication gently. Exhale through the inhalator set.
11. After finishing the treatment, turn off the device and disconnect the compressor from the power source.

Čistenie a dezinfekcia (Cleaning and Disinfection)

Wash your hands thoroughly before cleaning and disinfecting the inhalator parts. After each use, clean the device components to remove medication residue. This prevents ineffective inhalation and reduces the risk of infection.

Čistenie inhalačného setu, masky, náustku, nosného násadca a adaptéru (Cleaning the inhalation set, mask, mouthpiece, nasal aspirator, and adapter):

Wash them with warm water and a mild neutral detergent. Rinse them thoroughly in clean hot tap water, gently tap to remove excess water, and let them dry in a clean place.

Čistenie kompresora a vzduchovej hadičky (Cleaning the compressor and air tubing):

First, ensure the electrical plug is disconnected from the electrical outlet. Wipe them with a soft cloth dampened with water or a mild neutral detergent.

Dezinfikovanie inhalačného setu, masky, náustku, nosného násadca a adaptéru (Disinfecting the inhalation set, mask, mouthpiece, nasal aspirator, and adapter):

Always disinfect individual components before the first use of the product and after prolonged periods of non-use. Disinfect components once a week. Components are expected to withstand approximately 50 disinfection cycles. If components become heavily soiled, replace them with new ones. The inhalation set, mask, mouthpiece, nasal aspirator, and adapter can be disinfected using chemical disinfectants such as ethanol, sodium hypochlorite (Milton), quaternary ammonium salts (Osvan), chlorhexidine (Hibitane), and amphoteric surfactants (Tego), according to the instructions on the product, and rinse them with clean warm water. Allow to air dry.

Poznámka (Note): Do not clean the device with benzene, thinner, or any flammable liquids.

Vyváranie (Boiling):

The inhalation set, mouthpiece, nasal aspirator, and adapter can also be disinfected by boiling for at least 5 minutes in a large amount of water. After boiling, carefully remove the individual components, shake off excess water, and allow them to dry in a clean environment.

Poznámka (Note): Do not boil the mask and air tubing.

Výmena vzduchového filtra (Air Filter Replacement):

If the air filter changes color or has been used for more than 70 inhalations, replace it with a new one. For purchasing filters, refer to the section "Other Optional or Spare Parts". Remove the air filter cover using a flat-head screwdriver as shown in the illustration, remove the filter, and insert a new one as shown. Reattach the air filter cover.

Poznámka (Note): Do not wash or clean the air filter. If the air filter becomes wet, replace it. A wet air filter can cause leakage.

Riešenie problémov (Troubleshooting)

If any of the following problems occur during use, first check if any other electrical device is located within 30 cm of the unit. If the problem persists, refer below.

Zariadenie sa nezapne (Device does not turn on)

• Check if the power cord plug is properly connected to the outlet.
• Ensure the power switch is in the on position [power-on].

Zariadenie sa zapne, ale nerozprašuje (Device turns on but does not nebulize)

• Ensure the vaporizer head is attached to the inhalation set.
• Ensure the air tubing is not pinched or kinked.
• Check if the air filter is blocked or dirty. Replace if necessary.
• Ensure sufficient medication has been placed in the inhalation set.

Zariadenie počas prevádzky náhle prestane fungovať (Device suddenly stops working during operation)

• The thermal fuse has shut off the device for one of the following reasons:
  • The device was operated in an environment with temperatures higher than 40 °C.
  • The fan openings were covered.

Do not attempt to repair the device. Do not open or tamper with the device. The device contains no user-serviceable parts. Take the device to an authorized dealer or OMRON product distributor.

Report any serious incident that occurs in connection with this device to the manufacturer and the competent authority of the Member State in which you are established.

Záruka (Warranty)

Thank you for purchasing an OMRON product. This product has been manufactured with great care using high-quality materials. It is designed to provide you with the highest level of comfort, provided it is operated and maintained correctly as described in the user manual. OMRON provides a 3-year warranty on this product from the date of purchase.

OMRON warrants the product for correct design, workmanship, and materials. During this warranty period, OMRON will, without charge for labor or parts, repair or replace the defective product or any defective parts thereof. The warranty does not cover any of the following:

• a. Transportation costs and risks of transportation.
• b. Costs of repairs and/or damages resulting from repairs carried out by unauthorized persons.
• c. Routine inspection and maintenance.
• d. Failure or wear of optional parts or other accessories, other than the device itself, unless an express warranty is provided for them.
• e. Costs due to non-recognition of a claim (these will be charged).
• f. Damages of any kind, including personal damages, caused by accident or misuse.

If you require warranty service, contact the dealer from whom you purchased the product or an authorized OMRON distributor. The address can be found on the product packaging/documentation. You can also contact a specialized dealer.

Repair or replacement under warranty does not extend or in any way renew the warranty period.

Warranty claims can only be honored if the complete product is returned along with the original invoice/proof of purchase issued by the dealer to the customer. OMRON reserves the right to refuse warranty service if unclear information is provided.

Voliteľné zdravotnícke príslušenstvo (Optional Medical Accessories)

Ďalšie voliteľné alebo náhradné diely (Other Optional or Spare Parts)

Dôležité informácie týkajúce sa elektromagnetickej kompatibility (EMC) (Important Information Regarding Electromagnetic Compatibility (EMC))

This device complies with EN60601-1-2:2015 regarding electromagnetic compatibility (EMC). Further documentation in accordance with the EMC provisions of this standard is available from OMRON HEALTHCARE EUROPE at the address provided in this user manual or at the internet address www.omron-healthcare.com.

POSTUP LIKVIDÁCIE (WEEE) (Disposal Procedure)

This product must not be treated as normal municipal waste but must be taken to a collection point for the recycling of electrical and electronic equipment. For further information, contact your local authority, the waste disposal department of your local authority, or the retailer where you purchased the product.

Technické údaje (Technical Specifications)

MMAD = Mass Median Aerodynamic Diameter

GSD = Geometric standard deviation

** 3 ml, 0.1 % salbutamol in 0.9 % NaCl solution.

This device (compressor, inhalation set, air tubing, adapter, mouthpiece, nasal aspirator, adult and child masks) complies with the requirements of the European standard EN ISO 27427:2019 Anaesthetic and respiratory equipment – Nebulizing systems and components.

The nebulizer's efficiency varies for different types of medications in suspensions or very viscous solutions. For more information, refer to the medication leaflets.

Particle size distribution and aerosol output may vary depending on the combination of the product, medication, and environmental conditions such as temperature, humidity, and atmospheric pressure.

Nebulizer performance data is based on testing using adult breathing patterns and is likely to differ from data provided for pediatric or infant populations.

Diagram Description: A graph showing particle size distribution (Cumulative % mass of sub-micron particles of salbutamol vs. Particle size Dp (μm)).

Distribúcia a servis (Distribution and Service)

Pre SR (For Slovakia)

CELIMED s.r.o., Pri majeri 22, 831 06 Bratislava, SK

www.celimed.sk, info@celimed.sk

Výrobca (Manufacturer)

3A HEALTH CARE S.r.l.

Via Marziale Cerutti, 90F/G

25017 Lonato del Garda (BS)

Italy

Distribútor (Distributor)

OMRON HEALTHCARE EUROPE B.V.

Scorpius 33, 2132 LR Hoofddorp, NETHERLANDS

www.omron-healthcare.com

Dcérske spoločnosti Dovozca pre Spojené kráľovstvo a zodpovedná osoba v UK (Subsidiaries Importer for the United Kingdom and responsible person in the UK)

OMRON HEALTHCARE UK LTD.

Opal Drive, Fox Milne Milton Keynes, MK15 9DG, UK

www.omron-healthcare.com/distributors

OMRON MEDIZINTECHNIK HANDELSGESELLSCHAFT mbH / OMRON SANTÉ FRANCE SAS

www.omron-healthcare.com/distributors

Vyrobené v Taliansku (Made in Italy)