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EN> INSTRUCTIONS FOR USE MANUAL
DE> BEDIENUNGSANLEITUNG
FR > MODE D’EMPLOI
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ES > MANUAL DE INSTRUCCIONES
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Connection diagram - Anschlussschema - Schéma de montage -Verbindingsschema -Esquema de conexión
- Διάγραμμα συναρμολόγησης - Schemat połączeń dla nomenklatury-
POLSKI
Pag. 49
A5
A6 A4
C6
A3
A4
A1
A2
A7
C1
C2
C3
C4
C5
C2.1
C1
C1.1
C1.2
C1.3
C1.4
C1.1a
C1.1c
C1.1b
C1.1
تيصوتلا لودج
< AR
Pg. 57
1
Mod. CONDOR F2000
AEROSOL THERAPY DEVICE
We are pleased you have purchased our product and we thank you for your trust in us. We aim atfully satisfying our
customers by oering them state-of-the-art products for the treatment of respiratory diseases.
Read these instructions carefully and retain them for future reference. Only use the accessory as described
in this manual. This is a home medical device to nebulise and administer medication prescribed or
recommended by your doctor upon assessing the patient’s general conditions. Please note that the
full range of Flaem products is visible on the website www.aem.it.
STANDARD EQUIPMENT INCLUDES:
A - Aerosol apparatus (main unit)
A1 - On/O switch
A2 - Air intake
A3 - Air lter
A4 - Nebulizer holder
A5 - Handle for transport
A6 - Cable storage compartment
A7 - Power cable
C - Accessories
C1 - RF9 Nebulizer
C1.1 - Complete particle size regulator
C1.1a - Regulator
C1.1b - Valve
C1.1c - Selector
C1.2 - Upper part
C1.3 - Nozzle
C1.4 - Lower part
C2 - Mouthpiece with valve
C2.1 - Exhalation valve
C3 - Non-invasive nosepiece
C4 - Adult SoftTouch mask
C5 - Paediatric SoftTouch mask
C6 - Nebulization manual control
B - Connection tube
(main unit / nebulizer)
IMPORTANT WARNINGS
• This device is also intended for direct use by the patient.
• Before using the product for the rst time, and periodically during its lifetime, check the integrity of the device
structure and of the power cable to make sure there is no damage. In the event of damage, do not plug in the cable
and immediately take the product to an authorised FLAEM service centre or to your trusted dealer.
• Should your device fail to provide the expected performance, contact the authorised service centre for clarications.
• The expected medical life of the accessories is 1 year. It is, however, advisable to replace the nebulizer cup every 6
months in the event of intense use (or earlier if the cup is obstructed) to always guarantee maximum therapeutic
ecacy.
• Children and people who are not self-sucient must use the device under the close supervision of an adult who has
read this manual.
• Some parts of the device are small enough to be swallowed by children; therefore, keep the device out of the reach of
children.
• Do not use the supplied tubing and cables for anything other than their intended use. These parts could cause a
strangling hazard: pay close attention to children and persons with particular diculties as they are often unable to
accurately evaluate danger.
• The apparatus is unsuitable for use in presence of ammable anaesthetic mixture with air, oxygen or nitrous oxide.
• Always keep the power supply cable away from hot surfaces.
• Keep the power cable away from animals (for example, rodents) which could damage the insulation.
• Do not handle the device with wet hands. Do not use the device in damp environments (for example, while taking
a bath or shower). Do not immerse the device in water; in the event of immersion immediately disconnect the plug.
Do not remove or touch the immersed device; unplug the power cable rst. Immediately bring the device to an
authorised FLAEM service centre or to your trusted dealer.
• Use the device only in dust-free conditions, otherwise treatment could be compromised.
• Do not wash the device under running water or by immersion and keep it safe from being sprayed by water or other
liquids.
• Do not expose the device to particularly extreme temperatures.
• Do not place the device near sources of heat, in direct sunlight or in excessively hot rooms.
• Do not obstruct or put objects into the lter or its related housing in the device.
• Never obstruct the air vents located on both sides of the device.
• Always use it on a rigid surface that is clear of obstacles.
• Make sure there is no material obstructing the air vents before each use.
ENGLISH
2
• Do not put any objects in the air vents.
• Repairs, including the replacement of the supply cord, are to be carried out by FLAEM authorised personnel only, by
complying with the information provided by the manufacturer.
• The average expected duration for the compressor series are: F400: 400 hours, F700: 700 hours, F1000: 1000 hours,
F2000: 2000 hours.
• WARNING: Do not modify this device without authorisation from the manufacturer.
• The Manufacturer, the Vendor and the Importer shall be held responsible for safety, reliability and performance only
if: a) the device is used in compliance with the instructions for use b) the wiring where the device is being used is in
compliance with safety regulations and current laws.
• Interactions: the materials used in contact with medication have been tested with a vast range of medications.
However, in view of the variety and continuous evolution of pharmaceuticals, interactions cannot be ruled out. We
recommend using the medication as soon as possible once it has been opened and preventing prolonged exposure
in the nebulizer cup.
• The manufacturer must be contacted about any problems and/or unexpected events concerning operation and for
any clarications on use, maintenance/cleaning.
• Interactions: The materials used in the medical device are biocompatible in accordance with the provisions of
Directive 93/42 EC and subsequent amendments. However, the possibility of occurrence of allergic reactions cannot
be entirely excluded.
• The amount of time required between preservation conditions and use is approximately 2 hours.
ASSEMBLING THE NEBULISER
Follow the assembly instructions below.
1. Assemble the nozzle (C1.3) on the upper part (C1.2).
C1.3
C1.2 C1.2
C1.3
2. Place the valve (C1.1b) with the at side down onto the particle size regulator (C1.1a) by aligning the hole with the
position ribs, then screw the selector (C1.1c) onto the threaded pin of the regulator all the way down. Rotate the as-
sembled regulator to make sure that it turns freely and that the selector moves up and down between positions.
C1.1a
C1.1b
C1.1c
C1.1a +
C1.1b
Benets of BioCote protection
The enclosure of NebulFlaem 4.0 are made of ABS mixed with antimicrobial additive BioCote®, which makes the
surfaces protected 24 hours a day and permanently provides antibacterial, antifungal and antiviral properties. Store
accessories in a more secure environment.
3
4. Insert the assembled upper part (C1.1 + C1.2 + C1.3) into the lower part (C1.4) and hook it by turning it clockwise.
a
b
C1.1+C1.2+C1.3
C1.4
HOW TO USE THE RF9 NEBULISER WITH PARTICLE SIZE REGULATOR AND VALVE SYSTEM
It is professional, quick, recommended for administering all types of medicinal products, even in patients with chronic
diseases. The valve system optimises the dispensing of the nebulised medicinal product to the patient and limits its
dispersion in the environment. Moreover, thanks to the particle size regulator, the size of nebulised particles can be
selected based on the respiratory system area where the medication is to be delivered. Indeed, with the 4 available
modes, the bowl can dispense particles of dierent sizes:
RESPIRATORY
SYSTEM
UPPER
AIRWAYS
LOWER AIRWAYS
Oropharyngeal
tract
Tracheobronchial
tract
Pulmonary
tract
Peripheral
tract
CONFIGURATION
BOWL
Without
Selector
Selector in
position 1
Selector in
position 2
Selector in
position 3
MMAD (μm) 5,80(3) 4,67(1) 3,62(1) 2,56(1)
Output rate (ml/min’) 0,75(2) 0,54(2) 0,51(2) 0,38(2)
Breathable fraction
< 5 μm (FPF) 40,3 (3) 54,4(1) 66,3(1) 82,2(1)
(1) In vitro testing performed by TÜV Rheinland Italia S.r.l. in collaboration with the University of Parma and in compliance with the EN 13544-1: 2007 + A1
European Standard for aerosol therapy devices Standard. More details are available on request.
(2) Data measured according to Flaem I29-P07.5 internal procedure Dispensing speed values may vary according to the patient’s respiratory capacity. More
details are available on request.
(3) Data calculated on the basis of the values obtained with Malvern Spraytec, and compared with the values of the tests performed at the University of Parma.
C1.1c C1.1c
3. Insert and press the previously assembled particle size regulator (C1.1) all the way down, keeping it in a horizontal
position, in the upper part (C1.2), and matching the partitions of the selector (C1.1c) with the groove in the upper
part (C1.2).
C1.2
C1.1
C1.1c
