Laica NE2007 Product information sheet

www.laica.it
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TAGLIANDO
DI CONTROLLO
NE2007
APPARECCHIO A PISTONE
PER AEROSOLTERAPIA
LAICA S.p.A.
Viale del Lavoro, 10 - Fraz. Ponte
36021 Barbarano Vicentino (VI) - ITALY
Fax: [phone]
Made in China
HI16/b - 06/2011

Instructions et garantie
APPAREIL A PISTON
POUR AEROSOLTHERAPIE
Instructions and guarantee
PISTON NEBULISER
FOR AEROSOL THERAPY
Instrucciones y garantía
APARATO DE PISTON
PARA AEROSOLTERAPIA
Anleitungen und garantie
KOLBEN VORRICHTUNG
ZÜR AEROSOL-THERAPIE
Juhised ja garantii
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Instrucţiuni şi garanţie
APARAT CU PISTON PENTRU
TERAPIE CU AEROSOLI
ISTRUZIONI E GARANZIA
FR
GB
ES
DE
RO
EL
NE2007
APPARECCHIO A PISTONE
PER AEROSOLTERAPIA

LAICA S.p.A.
Viale del Lavoro, 10 - Fraz. Ponte
36021 Barbarano Vicentino (VI) - ITALY
Fax: [phone]
Made in China
ANNI DI GARANZIA
ANS DE GARANTIE
YEARS GUARANTEE
ANOS DE GARANTIA
JAHRE GARANTIE
XPONIA E°°YH™H
ANI DE GARANŢIE
Data - Date
Timbro rivenditore - Cachet du revendeur - Retailer’s stamp
Sello del revendedor - Stempel des Händlers
™ÊpaÁi‰a kataÛt‹mato˜ - Stampilă distribuitor
NE2007
www.laica.it

NE2007 APPARECCHIO A PISTONE PER AEROSOLTERAPIA
ACCESSORI IN DOTAZIONE
1) Tubetto Collegamento Aria
2) Corpo Inferiore Ampolla
3) Ugello di Nebulizzazione
4) Corpo Superiore Ampolla
Fig.2
Fig.3
Fig.1
SOSTITUZIONE DEL FILTRO
REPLACEMENT OF THE FILTER
5) Boccaglio
6) Mascherina adulti
7) Mascherina pediatrica
8) Filtri Aria
6
8
7
1 4 5
3
2

Please carefully read the instructions and warnings given in this handbook
before use, and always keep it with the nebulizer.
The piston nebulizer is one of the most effective instruments for treating respiratory
problems. The piston system gives very fast and fine nebulization, and can be used with
the majority of prescribed drugs, increasing the benefits of the treatment. Thanks to the
top quality performance, it could be considered a professional instrument. It is easy to
use and ideal for treatment at home. Reliable, tough and lubricant free, it is made in
conformity with European Standards in force regarding construction criteria and the safety
of electro-medical appliances (Standard EN 60 601-1, EN13544-1).
IMPORTANT
1) The apparatus must only be used for nebulizing treatment. Any other use is improper
and dangerous. The manufacturer is not responsible for any damage caused by
improper use.
2) The apparatus must not be used with anaesthetics that are inflammable when mixed
with air, oxygen or nitrous oxide.
3) Electromagnetic interference caused by the television, radio, etc., could affect the
working of the apparatus, it this happens, try moving it until the interference disappears
or, alternatively, plug into a different socket.
4) Do not use extension leads or adapters; the electric lead must be completely unwound
during use to avoid dangerous overheating. Keep the lead away from hot surfaces.
Never handle the plug with wet hands and never use the product while you are having
a bath or a shower.
5) This device has to be used only with the voltage values given on the bottom of the
product.
6) Always unplug the apparatus after use.
7) Caution! Do not intervene for any reason whatsoever on the electric cable. In case
of damage, refer to a dealer.
8) It must not be placed in water; if this should happen, unplug it immediately.
Do not attempt to touch it until it has been unplugged. Do not use the apparatus after
removing it from the water (contact the retailer immediately).
9) Always contact the retailer for any repairs.
Do not open or tamper with the apparatus. If it does not work properly turn it off and
consult the instruction handbook.
10)Place the device on flat and stable surfaces in order to avoid occluding vent openings
positioned on the sides.
11)Do not insert any object in the openings of the device.
12)Keep all the accessories out of the reach of children. Children and
invalids must only use the apparatus when supervised by an adult who
has carefully read the instruction handbook. Keep the bulb out of the
reach of children under 3 years old, as it contains small parts that could
be swallowed.Caution! This is not a toy, but a piston nebiliser for aerosol
therapy Do not leave the device unattended also when it is not used.
13)This is a medical instrument for home use, and must be used against
medical prescription. It must be operated in full conformity with this
instruction handbook. The patient must carefully read and understand
the instructions for its use and maintenance.
Contact the retailer for any further information that may be required.
OPERATING INSTRUCTIONS
1) Insert the plug in the power supply outlet corresponding to the appliance voltage. It
is recommended to uncoil the power supply cable for all its length to avoid hazardous
overheating.
2) See nebulizer instructions page.
3) Introduce the tube coming from the compressor OUTLET.
4) Assemble the selected care accessory: mask, mouthpiece or nosepiece.
5) Make sure that there is the standard supplied air filter.
6) After the treatment, switch off the device and disconnect the plug. Perform a careful
washing of the used parts. Before restarting the device, make sure that it has cooled
and achieved ambient temperature.
Caution:
• Always use the ampoule facing upwards in order not to let any substance or
medical product come out from the ampoule itself during normal use.
• Never inhale in horizontal position
Laica S.p.A. - Viale del lavoro, 10
36021 Barbarano Vicentino (VI) - Italy
Made in China
ACCESSORIES SUPPLIED
1) Air tube
2) Ampoule lower body
3) Atomisation nozzle
4) Ampoule upper body
5) Mouthpiece
12
GB English PISTON NEBULISER FOR AEROSOL THERAPY

6) Mask for adults
7) Mask for children
8) Air filters
CLEANING AND DISINFECTING
Wash your hands well before beginning to clean and disinfect the accessories.
Do not wash the apparatus under the tap or by soaking. If it needs cleaning, just use a
cloth dampened with detergent (not abrasive and not solvent).
Device with enclosure not protected against the penetration of liquids.
To disinfect the accessories, it is possible to use denatured spirit or a hypochlorite solution
that can be easily purchased at any chemist’s shop.
Before and after each use, clean all nebuliser components (exception made for the air
tube) removing any medical product residuals or any dirt deposits.
Clean all components with lukewarm water and/or neutral soap; rinse them carefully
removing excess water and let them dry in the open air in a clean place. Never boil the
accessories.
To dry the humidity or condensate present in the air tube, switch on the device for 2/3
minutes letting only the tube connected; otherwise, let it dry at open air in a clean place.
Clean the external part of the tube with a wet cloth.
Replacement of the spare filter: Air filter has to be replaced every 500 hours of
operation or in any case when the same is rather dirty. It is suggested to replace the filer
every time that the ampoule is replaced (about every 6 months).
Do not wash the used filters to reuse them again.
To replace the filter, lift the filter holding cover, remove the filter to be replaced and insert
the spare one.
Then, insert the filter holding cover in its proper seat letting it adhere well to the surface.
Use only original Laica filters.
Cleaning of the ampoule: see ampoule instruction section
MICROBIC CONTAMINATION
In the presence of conditions carrying the risk of microbial infection and contamination,
personal use of the accessories and nebulizer only is advised (always consult a doctor).
PROBLEMS, CAUSES AND REMEDIES
The apparatus does not turn on:
• ensure the plug is well into the socket.
• ensure the switch is in the on position (I).
The apparatus is alight but does not nebulize:
• ensure the air connection tube is not squashed or bent.
• ensure the air suction filter is not blocked or dirty. If necessary, replace with a new
one.
• ensure the required drug is inside the bulb.
• make sure that the ampoule is not clogged; then, clean and disinfect the ampoule as
indicated in the manual. If the washing was not successful, replace the ampoule.
• make sure that the nozzle is not badly mounted; press firmly with a finger on the
nozzle (cylindrical sleeve), which is positioned within the polycarbonate ampoule
bottom.
The appliance atomises slowly:
• the medicinal product may be very oily. Dilute the medicinal product using
physiological saline.
The appliance is noisy after prolonged use:
• Refer to the dealer.
The appliance does not work:
• the appliance has worked close to heat sources or in environments with a temperature
exceeding 40°C. The thermal protection has tripped. Let the appliance cool for at
least 60 minutes and then switch on the appliance again.
N.B. if the apparatus still does not work correctly, contact the retailer.
HOW TO RETURN ITEMS
In compliance with the new European Regulations, LAICA lists here below
some essential points to preserve the hygiene of appliances and operators
using the same.
LAICA relies on the observance of these procedures to assure the hygiene
and health of all people operating in order to obtain quality and wellness.
Each appliance that shall be returned to LAICA shall be subject to hygienic controls before
technical service. In case of goods return for replacement, it is COMPULSORY to:
• disinfect carefully the external part of the main unit using a cloth moistened with
denatured spirit or a hypochlorite solution.
• disinfect the accessories plunging them in the same disinfecting solutions.
• insert everything in a bag specifying “appliance with disinfected accessories”.
• always specify the detected defect before returning the product.
TECHNICAL SPECIFICATION
Piston electrocompressor with thermal cut-out
13
Instructions and guarantee GB
English

Class II apparatus
Type B apparatus
Important - please check the operating instructions
Switch turned off
Switch turned on
Alternating current
Do not use the apparatus while having a bath or shower
Fuses: F 1 x 2A 250V
Power feeding: 230V~ / 50Hz
Power consumption: 140VA
Max pressure: 250 kPa (2.5 bar)
Max air flow: 10 l/min
Operating pressure: 72.4 kPa (0,724 bar)
Operating air flow: > 5 l/min at 72.4 kPa
Neb-rate: 0.30 ml/min with 4 ml of 0.9% NaCl solution
MMAD (measured as specifications of EN13544-1): 1.8 µm
GSD: 2.87
Weight: 1.33 kg
Dimensions: 168 x 165 x 90 mm
Noise level: approx. 60dB (A)
Functioning (to 40° and 110% operating voltage): 20/40 min. ON/OFF
Min. capacity nebuliser: 1 ml
Max. capacity nebuliser 8 ml
Preserve in place coolness and dry land
Working conditions:
Temperature: min. 10°C; max 40°C,
Air humidity: min. 30% max 75%
Storage conditions:
Temperature: min. 10°C; max 40°C,
Air humidity: min. 30% max 75%
Temporary use: 20/40 min. ON/OFF
DISPOSAL PROCEDURE (DIR. 2002/96/EC - WEEE)
The symbol on the bottom of the device indicates the separated collection of
electric and electronic equipment. 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.
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 equipment is covered by a 2-year warranty elapsing from the purchase date, which
has to be proven by means of the stamp or signature of the dealer and by the
fiscal payment receipt that shall be kept enclosed to this document. This
warranty period complies with the laws in force (Italian legislative decree No. 24 dated
Feb. 02, 2002 and following “Consumers’ Act” Italian legislative decree No. 206 dated
Sep. 03, 2005) and applies only in case the consumer is a private entity. Laica products
are designed for domestic use; therefore, their use in public businesses is forbidden.
The warranty covers only production defects and is void, if the damage is caused by
accidental events, wrong use, negligence or improper use of the product. Use the supplied
accessories only; the use of other accessories may lead to warranty voidness. Do not
open the equipment for any reason whatsoever; in case of opening or tampering of the
equipment, warranty decays definitively. Warranty does not apply to parts subject to tear
and wear along the use, as well as to batteries, when they are standard supplied. Warranty
decays after 2 years from the purchase date. In this case, technical service interventions
will be carried out against payment. Information on technical service interventions, under
warranty terms or against payment, may be requested by writing at [email protected].
Nothing shall be owed for the repairing or replacement of products covered by the warranty
terms. In case of faults, refer to a dealer; DO NOT send anything directly to LAICA. All
interventions covered by warranty (including product replacement or the replacement of
any of its parts) shall not be meant to extend the duration of the original warranty period
of the replaced product.
The manufacturer cannot be made liable for any damages that may be caused, directly
or indirectly, to people, things and pets resulting from the inobservance of the provisions
contained in the suitable user manual, especially with reference to the warnings related
to installation, use and maintenance of the equipment. Being constantly involved in
improving its own products, Laica reserves the right to modify its product, totally or
partially, with reference to any production need, without that this involves any
responsibility whatsoever by Laica or its dealers.
14
GB English PISTON NEBULISER FOR AEROSOL THERAPY

NEBULIZER 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 pour the medication rotate the nebulizer top counter clockwise and
remove it. Pour the quantity of medication prescribed by your doctor into the nebulizer tank.
IMPORTANT: In case you do so, empty the nebulizer, clean it thoroughly and proceed with new
filling. Once the medicinal product has been poured, screw again the top part on the bottom
one; then connect the air tube to the air outlet hub. Connect the other end of the tube to the
connection on the lower part of the nebuliser and then connect the accessories prescribed by
the doctor to the nebuliser itself.
Start the compressor for treatment to begin.
IMPORTANT: NEVER INHALE IN HORIZONTAL POSITION.
CLEANING INSTRUCTION
Before and 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.
Clean all components with lukewarm water and/or neutral soap; rinse carefully removing excess
water and let them dry in the open air in a clean place.
To disinfect the accessories, proceed as follows:
1) Rotate the upper part of the nebuliser counter-clockwise.
2) Disconnect the pisper within the bottom of the nebuliser by pulling firmly with the fingers.
3) To disinfect the accessories, it is possible to use denatured spirit or a hypochlorite solution
that can be easily purchased at any chemist’s shop.
4) After use, disassemble the ampoule and clean all parts using lukewarm water; rinse carefully
and remove excess water with a soft cloth; then, let them dry in the open air in a clean place
Never boil the accessories.
USEFUL LIFE OF THE APPLIANCE
For each single patient, it is suggested to use the ampoule for 6 months or for 120 treatments
maximum. The nebuliser has to be replaced after a long standstill, if it shows deformations or
breaks, or in case the atomisation nozzle is clogged by dry medicinal product, dust, etc.
Use exclusively original accessories foreseen and indicated by the Manufacturer.
STORAGE AND TRANSPORTATION CONDITIONS
Storage and transportation temperature: +10°C (50°F) ÷ +40°C (104°F)
Storage and transportation humidity percentage: 30% ÷ 75% RH
OPERATING TECHNICAL DATA
Operating Minimum flow: > 5 l/min
Relative operating pressure: 72.4 kPa (0.724 bar) +/- 10%.
Min. capacity: 1 ml
Max. capacity: 8 ml
Read carefully instructions for use
15
Instructions and guarantee GB
English