NE2012 - Nebulizer LAICA - Free user manual and instructions

Frequently Asked Questions - NE2012 LAICA

USER MANUAL NE2012 LAICA

2. Accessory compartment lid

3. Accessory compartment

4. On/off "O/I" switch

5. Compressor air connection

6. Air filter compartment lid

WarningSymbol for "Type BF applied parts" Prohibition

In compliance with European legislation on medical devicesCaution! Read the user instructions carefullyManufacturerClass II appliance LOT Batch production numberSwitch on Switch offDo not use the device while bathing or showering IP21: Degree of protection of electrical equipment covers, where the first figure indicates the degree of protection against penetration by solid foreign bodies (from 0 to 6) and the second figure the degree of protection against penetration by liquids (from 0 to 8). SAFETY WARNINGS

• Before using, make sure the appliance is intact and shows no visible damage. If in doubt, do not use the product and contact your retailer.• Keep the plastic packaging out of reach of children: suffocation hazard.• This device must only be used for its intended purpose and in the manner indicated in the instructions.

English Any other use is considered inappropriate and therefore dangerous. The manufacturer cannot be held liable for any damage resulting from misuse or incorrect use.• Before connecting the appliance, make sure the mains voltage corresponds with the voltage on the plate located on the product.• Children aged 14 years or older, people with physical, sensory or mental disabilities or unskilled people, may use and maintain the product only under adult supervision. Children must not play with the device. Keep the bulb away from children younger than 36 months because it contains small parts that could be swallowed. In any case, keep the accessories and power cord out of reach of children (danger of strangulation).

• This is a medical device for home use and must be used after a medical prescription. It must be operated as indicated in this instruction manual. The patient must read and understand all information on how to use and maintain the unit. Contact your retailer if you have any questions.• The appliance is not suitable for use in the presence of inflammable anaesthetic mixtures with air, oxygen, or nitrous oxide. NEVER leave the appliance operating unsupervised. Once finished using, turn it off and unplug it from the mains. • Handle the product with care, protect it against impacts, extreme temperature fluctuations, humidity, dust, direct sunlight and sources of heat.• In the event of a failure and/or malfunction, turn off the device without tampering with it and consult the instruction manual. For any repairs always contact your retailer. Do NOT connect or disconnect the appliance with wet or damp hands.• Make sure your hands are dry when touching the "O/I" switch. Do NOT pull on the power cord or the device itself to unplug. NEVER use extension cords or adapters. Pull the cord out for its entire length and keep away from heat sources. Attention! Do NOT tamper with the power cord for any reason. In case of damage contact your retailer.• Always use the "O/I" switch to turn the appliance off and then unplug.• Unplug the appliance immediately after use and always before cleaning. NEVER submerge the product in water or any other liquids. If the device falls in the water, do NOT try to pick it up. Immediately unplug it. Do NOT reuse the device after removing it from the water (immediately contact the retailer).

1) Before using the device for the first time, clean it as described in the section

"Maintenance and disinfecting".

2) Insert the plug in the socket.

3) Prepare the bulb as indicated in the section "nebulizer bulb instructions".

4) Firmly connect one end of the air hose to the bulb and insert the other in the

compressor air connection.

5) Apply the chosen accessory: mask, mouthpiece, or nosepiece, as prescribed by

6) Turn on the appliance pressing the "O/I" switch in position "I". Insert the

mouthpiece or put on the mask making sure it covers the mouth and nose. Using the mouthpiece improves delivery of the drug to the lungs.

7) Inhale and exhale normally during the treatment. Sit upright in a relaxed position.

Do not lie down during inhalation. Stop inhalation if feeling sick.

8) Once inhalation is complete, turn off the appliance by switching the on/off switch

9) Remove the air hose from the bulb and compressor air connection.

IMPORTANT: Like most aerosol therapy appliances, at the end of the inhalation treatment, a certain amount of the drug will remain in the bulb. This is perfectly normal. This amount of the drug, also called the residual volume, cannot be atomized.

10) Empty any drug residue from the bulb and clean it as described in the paragraph

"Instructions for cleaning the device", section "nebulizer bulb instructions" and clean the other parts used as described in the paragraph "Maintenance and disinfecting".

11) Wind the cord and store it in the compartment on the back of the appliance.

This device was designed for intermittent operation - 20 min. On / 40 min. Off. Turn the device off after 20 minutes of operation and wait another 40 minutes before performing a new treatment.

MAINTENANCE AND DISINFECTION

• Clean hands thoroughly before proceeding with cleaning the machine and accessories.

• Carefully clean all of the parts and remove the drug residues and possible impurities after every treatment.

• The main unit and air hose must be cleaned with a clean, dry cloth. Never clean the appliance under running water or by immersion. The appliance cover is not protected against liquid penetration.

• Cleaning with water: Clean all of the accessories, except the air hose, under running water (max. 60°C) for about 5 minutes, adding a small amount of detergent, if necessary, following the doses and limitations indicated by the detergent manufacturer. Rinse thoroughly, making sure that all of the residues are removed and allow to dry.

• Disinfection: All of the accessories, except for the air hose, can be disinfected with chemical disinfectants according to the doses and limitations indicated by the disinfectant manufacturer. Disinfectants can normally be purchased in the pharmacy.

• Steam sterilization: All the parts of the nebuliser (except for the air connection tube and masks) can be sterilized with steam. They can withstand sterilization cycles up to 121°C for a maximum of 20 minutes or up to 134°C for a maximum of 7 minutes. After sterilization, always the parts to cool down to room temperature before using again. Never repeat the sterilization cycle when the parts are still hot. Check the sterilization temperatures and times with the manufacturer of the sterilizer.

• Replacing the air filter: To replace the air filter, lift the air filter compartment lid using a flathead screwdriver as shown in Fig. 2. Remove the filter to be replaced and insert the new one. Finally, replace the air filter compartment lid, making sure it adheres well to the surface. We recommend replacing the filter after every 70 treatments.

• Microbial contamination: In the presence of illnesses with a risk of infection and microbial contamination, we recommend personal use of the accessories and nebulizing bulb (always consult your physician).

• Store the appliance in a cool, dry area.

NEBULIZING BULB INSTRUCTIONS

Designed and created in accordance with the latest standards, is an Medical Device (Risk Class IIa - MDD 93/42/EEC) highly efficient in medical therapies administered by means of aerosol nebulization. SAFETY WARNINGS

• A single-patient use is recommended

• The device should be used only with compressor nebulizers for aerosoltherapy that comply with standards in force and whose use is indicated in the instruction manual

• Device not suitable for anaesthesia and lung ventilation

• The device should be used only with original accessories shown in this manual

• Information concerning connection and use with devices for aerosoltherapy are shown in the instruction manual of the devices. Always observe instructions and safety warnings as indicated in the instruction manuals of the devices for aerosoltherapy

• Use the device and its accessories as per your doctor’s recommendations

• Use medications prescribed by your doctor according to his indications Do not use the device for other use than Nebulizer for Aerosoltherapy. Manufacturer will not be held responsible for inappropriate use of the device

• The device does not come in sterile pack; always carry out cleaning and sterilization operations before and after each treatment. When using the device follow ordinary hygiene and cleaning precautions, (wash your hands and carry out cleaning operations as described in the specific section of this manual)

• The device has small components which might be removed and easily swallowed. Use by minors and disabled people require presence of an adult with his faculties. Do not leave the device unattended in places easily accessible by minors and disabled people.

• Always store the device in a dry and clean place far from light, heat and weather

• Dispose of device as provided by standards in force

• In presence of pathologies with microbial contamination and infection hazard a singlepatient use of accessories and nebulizer is recommended (always consult your doctor) HOW TO PREPARE AND TO OPERATE THE DEVICE The device is not sterile. Before use carry out cleaning and disinfection operations as described in the specific section. To insert the medicine, squeeze the bottom of the nebulizer bulb and turn the top counter clockwise to release. Remove the top, make sure the nebulizer nozzles (no. 13b in the exploded view) are correctly inserted in the bottom of the bulb (see Fig. 3), and insert the amount of medicine prescribed by the doctor in the bottom of the nebulizer bulb. IMPORTANT: In case you do so, empty the nebulizer, clean it thoroughly and proceed with new filling. When medication has been poured, connect the nebulizer top onto the tank, rotate clockwise and insert the accessory prescribed by your doctor into the nebulizer top. Firmly connect one end of the air tube to the nebulizer and the other end to the air outlet on the compressor nebulizer for aerosoltherapy. Start the compressor for treatment to begin. IMPORTANT: NEVER INHALE IN HORIZONTAL POSITION. NEVER BEND THE NEBULIZER OVER 60°. CLEANING INSTRUCTION After each treatment clean thoroughly each component of the nebulizer removing medication residuals and possible impurities. Clean each component as described here below except the air tube which -in case of treatment to a new patient or in case of impurities should be replaced. Wash all components (except air tube) under tap warm water (about 60°C -140°F) for about five minutes adding if necessary a small quantity of detergent following dosage and use limitations as provided by detergent manufacturer. Rinse thoroughly making sure that all deposits are washed away and let dry. All nebulizer components can be disinfected (except air tube) with chemical disinfectants following dosage and use limitations as provided by disinfectant manufacturer. They are usually available at pharmacy shops (Milton®, Amuchina® etc.). All nebulizer components can be heat steam sterilized (except air tube and masks) to 121°C (20 min.) or 134°C (7 min.). After sterilization always let all nebulizer components cool down to ambient temperature before use. Do not repeat sterilization cycle when nebulizer components are still warm.

It is advisable replace nebulizer after some 100 to 120 treatments on single patient or after about 20 sterilization cycles.

STORAGE AND TRANSPORTATION CONDITIONS

Storage and transportation temperature: - 25°C ÷ +70°C Storage and transportation humidity percentage: 10% ÷ 95% RH

OPERATING TECHNICAL DATA

Operating Minimum flow: 5 l/min +/- 10% Operating pressure: 60 kPa (0.6 bar, 8.7psi) +/- 10% Operating Max flow: 7.5 l/min +/- 10% Operating pressure: 150 kPa (1.5 bar, 22.05psi) +/- 10% Min. capacity: 2 ml Max. capacity: 12 ml Read carefully instructions for use TROUBLESHOOTING Problem Possible cause Solution The appliance will not turn on. The appliance is not plugged in. Plug the product into the electrical socket. The "O/I" switch is set to "O". Turn on the appliance pressing the "O/I" switch in position "I". The appliance is on but does not nebulize. The nebulization nozzle was not inserted in the bulb (no. 13b). Insert the nebulization nozzle in the bulb as described in fig. 3. The air hose is bent or crushed. Extend the air hose. The air filter is obstructed or dirty. Replace the air filter. There is no drug inside the bulb. Insert the drug in the bulb as prescribed by the doctor. Problem Possible cause Solution The appliance is not working The thermal protector was triggered for the following reasons: Allow the appliance to cool for at least 60 minutes and then turn it back on. The appliance was working outside of the operating limits indicated in this manual. The appliance was operating near a heat source or in areas with temperatures exceeding 40°C. Please Note: When the appliance does not recover proper operation despite having checking these items, contact the retailer. ELECTROMAGNETIC COMPATIBILITY This device complies with current regulations relating to electromagnetic compatibility (EMC) and has been designed to be used in the home. Its emissions are extremely small and are unlikely to generate interference with other equipment. In the event that it is to be used in close proximity to other equipment, it is recommended to follow the instructions given in the tables at the end of the instructions for use. Certain mobile communications devices and radio systems may have an effect on the operation of this device. In cases where there are anomalies during operation, it is recommended to distance the device from any other equipment that could cause electromagnetic interference and check for the restoration of performance. In all cases, in the event of doubt, contact Customer Support or see the tables relating to electromagnetic emissions at the end of these instructions. DISPOSAL PROCEDURE The symbol on the bottom of the device indicates the separated collection of electric and electronic equipment (Dir. 2012/19/Eu-WEEE). At the end of life of the device, do not dispose it as mixed solid municipal waste, but dispose it referring to a specific collection centre located in your area or returning it to the distributor, when buying a new device of the same type to be used with the same functions. If the appliance to be disposed of is less than 25 cm, it can be returned to a retail location that is over 400 m² without having to purchase a new, similar device. This procedure of separated collection of electric and electronic devices is carried out forecasting a European environmental policy aiming at safeguarding, protecting and improving environment quality, as well as avoiding potential effects on human health due to the presence of hazardous substances in such equipment or to an improper use of the same or of parts of the same. Caution! The wrong disposal of electric and electronic equipment may involve sanctions. WARRANTY This appliance is guaranteed for 2 years from the time of delivery of the goods, or another longer term envisaged by the national legislation of the consumer's residence. This provision complies with Italian and European legislation. The Laica products are designed for home use and must not be used in public venues. The warranty only covers manufacturing defects and does not apply if the damage is caused by an accidental event, incorrect use, negligence or misuse of the product. Use only the accessories supplied; the use of different accessories may result in invalidity of the warranty. Do not open the unit for any reason; in the case of opening or tampering, the warranty is definitively voided. This warranty does not apply to parts subject to wear or to the batteries when supplied. After 2 years from delivery, or another longer term envisaged by the national legislation of the consumer's residence, the warranty expires; in this case, the technical assistance interventions will be carried out against a fee. Information on technical assistance, whether under warranty or for a fee, can be requested by contacting [e-mail]. No payment will be due for repairs or replacements of products that fall within the terms of the warranty. In the event of faults, contact the retailer. Do NOT send the appliance directly to LAICA. All the operations under warranty (including those of replacement of the product or part thereof) will not prolong the duration of the original period of warranty of the product replaced. The manufacturer declines any liability for any damage that may, directly or indirectly, be caused to persons, property or animals as a result of the non-observance of all the requirements established in the relevant instructions manual and concerning, especially, warnings relating to installation, use and maintenance of the appliance. Laica, in its constant commitment to improving its products, is entitled to changing without any notice, in whole or in part, its products in relation to production requirements, without this entailing any liability for Laica towards its dealers. For further information: www.laica.it.

English18 19 Electromagnetic compatibility – additional notes in conformity with the IEC 60601-1-2/A1:2004-09 Standard The DEVICE is intended for use in the electromagnetic environment specified below. The customer or the user of the DEVICE should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment – guidance RF emissions CISPR 11 Group 1 The DEVICE uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. RF emissions CISPR 14

The DEVICE is suitable for use in all establishments and those directly connected to the public low-voltage power supply network that supplies buildings used to domestic purposes. It is possible to use the device in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes, adopting provisions in the installation, such as a longer distance from potentially sensitive appliances. Harmonic emissions

Class A Conforms It is possible to use the device in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings user for domestic purposes. Voltage fluctuations/ flicker emissions

Complies Immunity aspects at r.f. The DEVICE is intended for use in the electromagnetic environment specified below. The customer or the user of the DEVICE should assure that it is used in such an environment. Immunity test Test Level EN 60601-1-2 Compliance level Electromagnetic environment – guidance RF conducted EN 61000-4-6 3 Veff from 150kHz to 80MHz 3 Veff from 150kHz to 80MHz Portable and mobile RF communications equipment shouldbe used no closer to any part of the device, including cables, than the recommended separation distance calculated from that equation applicable to the frequency of the transmitter. Recommended separation distance: where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m). RF radiated EN 61000-4-3 3 V/m from 80MHz to 2,5GHz 3 V/m from 80MHz to 2,5GHz Field strengths from fixed RF transmitters, as determined by an electromagnetic site survery, c should be less than the compliance level in each frequency range. Interference may occur in the vicinity of equipment marked with the following symbol: For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be determined using the equation to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer Notes: (1) At 80 MHz and 800 MHz the separation distance for the higher frequency range applies. (2) These guidelines may not aplly in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Recommended separation distances between portable and mobile RF communications equipment and the DEVICE The DEVICE is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the DEVICE can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the DEVICE as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter

Separation distance according to frequency of transmitter

Immunity aspects The DEVICE is intended for use in the electromagnetic environment specified below. The customer or the user of the DEVICE should assure that it is used in such an environment. Immunity test Test level EN 60601-1-2 Compliance level Electromagnetic environment – guidance Electrostatic discharge

± 6 kV contact ± 8 kV air ± 6 kV contact ± 8 kV air Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Burst/Fast Transient EN 61000-4-4 ±2kV power supply lines ±2kV power supply lines Mains power quality should be that of a typical commercial or hospital environment. Surge EN 61000-4-5 ±1kV differentail mode ±2kV common mode ±1kV differentail mode ±2kV common mode Mains power quality should be that of a typical commercial or hospital environment. Voltage dips, short interruptions and voltage variations on power supply input lines EN 61000-4-11 < 5% UT (>95% dip in UT) for 0,5 cycles 40% UT (60% dip in UT) for 5 cycles 70% UT (30% dip in UT) for 25 cycles < 5% UT (>95% dip in UT) for 5 seconds < 5% UT (>95% dip in UT) for 0,5 cycles 40% UT (60% dip in UT) for 5 cycles 70% UT (30% dip in UT) for 25 cycles < 5% UT (>95% dip in UT) for 5 seconds Mains power quality should be that of a typical commercial or hospital environment. If the user of the device requires continued operation during power mains interruptions. It is recommended that the DEVICE be powered from an uninterruptible power supply or a battery. Power frequency magnetic field EN 61000-4-8 3 A/m 3 A/m Magnetic power frequency fields should be that of a typical commercial or hospital environment.20 21uso y antes de la limpieza. NUNCA sumerja el producto en agua o en otros líquidos. Si el aparato cae al agua NO trate de cogerlo, en lugar de ello desenchúfelo de inmediato. NO volver a utilizar el aparato después de haberlo quitado del agua (contactar inmediatamente al revendedor). NO usar el aparato durante el baño o la ducha.

PROBLEMAS E SOLUÇÕES

PROBLEMAS E SOLUÇÕES