alvita T2000 User manual

Inhalator T2000
Für die ganze Familie
Schnelle, leise und eektive Vernebelung
Inhalator T2000
Geschikt voor de hele familie
Snel, stil, eectief
Nebuliser T2000
For all of the family
Fast, quiet, eective
Nébuliseur T2000
Pour toute la famille
Rapide, silencieux, ecace
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Technische gegevens
Mod.: T2000
Voltage:
Maximale druk:
Luchtuitstoot van de compressor:
Geluidsniveau (op 1 meter):
Gebruik:
In overeenstemming met:
Afmetingen (W)x(D)x(H):
Gewicht:
Toegepaste onderdelen
BF type onderdelen zijn :
Gebruiksomstandigheden
Temperatuur: min. 10°C; max. 40°C
RH Luchtvochtigheid: min. 10%; max. 95%
Luchtdruk: min. 69KPa; max. 106kPa
Voorwaarden voor opslag
Temperatuur: min. -25°C; max. 70°C
RH Luchtvochtigheid: min. 10%; max. 95%
Luchtdruk: min. 69KPa; max. 106kPa
RF8 Plus Nebulisator
Minimale capaciteit
van medicatie
ml
Maximale capaciteit
van medicatie
ml
(1) Werkzame
bar (ongeveer)
(1) toevoer
ml/min (ongeveer)
(2)MMAD
μm
(2)Ademende
fractie < 5 μm
%
2 8 1,3 max min max min max min
0,44 0,28 4,12 3,69 59,8 64,2
(1) Waarden gemeten conform Flaem’s interne procedure I29-P07.5. Afgeleverde hoeveelheid kan veranderen naar gelang de ademcapaciteit van de patiënt.
(2) In vitro testen gecertificeerd door TÜV Rheinland LGA Products GmbH - Duitsland in overeenstemming met de Europese norm EN 13544-1 voor
vernevelsystemen. Verdere details zijn beschikbaar op aanvraag.
AFVALVERWERKING
In overeenstemming met richtlijn 2002/96/EC, dient dit apparaat beschouwd te worden als afval en daarom valt onder de recycle-regeling. De gebruiker moet
dus rekening houden, dat bovenstaand afval naar een voorgesorteerd afvalinzameling centrum moet worden gebracht. Of dat het apparaat terug kan worden
gebracht naar de dealer bij aankoop van een nieuw apparaat van hetzelfde type. Voorgesorteerd afvalinzameling en de daaropvolgende behandeling beperkt
de negatieve gevolgen van eventueel onjuist afvalbeheer voor het milieu en de volksgezondheid. Het weggooien op een onrechtmatige manier door de
gebruiker kan leiden tot administratieve boetes, zoals bepaald door de wetten tot omzetting van Richtlijn 2002/96/EG van het Europese lidstaat of van het land waar
het product wordt verkocht.
ELECTROMAGNETISCHE COMPATIBILITEIT
Dit apparaat voldoet aan de huidige eisen voor elektromagnetische compatabiliteit (EN 60601-1-2:2007). Elektro-apparaten vereisen speciale zorg tijdens installatie
en gebruik. Op basis van de EMC-eisen is het noodzakelijk dat ze worden geïnstalleerd en/of gebruikt volgens de specificaties van de fabrikant. Er is een potentieel
risico op elektromagnetische interferentie met andere apparaten, met name andere inrichtingen voor analyse en behandeling. Radio en mobiele of draagbare RF-
communicatie apparaten (mobiele telefoons of draadloze verbindingen) kunnen interfereren met de werking van elektromedische apparaten. Voor meer informatie
kunt u terecht op www.flaemnuova.it. De fabrikant behoudt zich het recht voor om technische en functionele veranderingen in het product aan te brengen zonder
voorafgaande kennisgeving.
Klasse II apparaat
Belangrijk: check de gebruiksaanwijzing
“UIT” voor een deel van het apparaat
“AAN” voor een deel van het apparaat
Voldoet aan : Europese norm EN 10993-1 “Biologische evaluatie
van medische hulpmiddelen” en Europese Richtlijn 93/42/EEG
“medische hulpmiddelen”
Droog houden
type BF
Wisselstroom
Risico: Elektrocutie.
Gevolg: Dood
Gebruik het apparaat niet terwijl u in bad zit of onder de
douche staat
CE Markering Medische ref. Dir. 93/42 EEG en latere
wijzigingen.
Voldoet aan EN 60601-1-11
Fabrikanten
Serienummer van het apparaat
SYMBOLEN
230V ~ 50Hz 140VA
2.6 ± 0.4 bar
10 l/min approx
54 dB (A) approx
continuous
21x16x11 cm
1.45 kg
Patiënt accessoires
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Please read these instructions carefully and keep them for future reference. Use this device only as described
in this manual. This is a home medical device for the nebulisation and administration of medication prescribed
or suggested by your doctor.
THIS DEVICE COMES EQUIPPED WITH:
A – Aerosol Therapy Device (main unit)
A1 – On/o switch
A2 – Air outlet port
A3 – Air filter
A4 – Nebuliser holder
A5 – Power cord
A6 – Socket for power cord
A7 – Carrying handle
B – Connection tube (main unit / nebuliser) *
C – Accessories
C1 – RF8 Plus nebuliser
C1.1 – Lower part **
C1.2 – Upper part with valve and speed selector
C1.2.1 – Upper part **
C1.2.2 – Inspiratory valve system **
C1.2.2 a – Inspiratory valve ***
C1.2.2 b – Valve retainer **
C1.2.3 – Speed selector **
C2 – Mouthpiece with valve **
C2.1 Expiratory valve ***
C3 – Nasal prong **
C4 – Adult face mask †
C5 – Pediatric face mask †
C6 – Manual nebulisation control ‡
D – Convenient, roomy carrying bag
UK
Nebuliser T2000
Aerosol Therapy Device
Assembly diagram
A
B
C
D
C4
C5
A3
A1
A5
A2
A7
A4
C1.1
C1.2
C2 C6
C1.2.1
C1.2.2
C1.2.3
b
a
C1 C1.2
)
A6
C2.1 C1
C3
Materials
* PVC (Phthalate free) with TPU connectors
** Polypropylene
*** Silicone
† Polypropylene and thermoplastic rubber
‡ Polyethylene
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Indications
The Alvita Nebuliser T2000 is used for the treatment of respiratory diseases such as bronchitis and asthma by
administering medications prescribed or suggested by your doctor in an aerosolised form.
Contraindications
The Alvita Nebuliser T2000 should not be used with patients that are mechanically ventilated.
INSTRUCTIONS FOR USE
• Before using the unit for the first time, and periodically throughout its life, check the power supply
cord for any damage. If you detect any damage, do not plug it in and contact Alvita using the contact
details provided at the bottom of this leaflet.
• Before each use, the aerosol therapy device and accessories should be cleaned according to the
Cleaning Instructions.
• Only use the device in dust-free environments; otherwise, therapy may be compromised.
• The unit should not be used in the presence of anaesthetic mixtures inflammable with air, oxygen or
nitrous oxide.
1. Plug the power cord (A5) into the unit socket (A6) and plug the power cord into a power socket
corresponding to the voltage of the unit. The power cord must be positioned so that it is not dicult to
make the disconnection from the mains.
2. Open the nebuliser chamber by turning the upper part (C1.2) counterclockwise.
3. Pour the medication prescribed by the physician into the lower part (C1.1).
Close the nebulizer chamber by turning the upper part (C1.2) clockwise.
4. Connect accessories as indicated in the “Assembly diagram” on the cover.
5. Sit comfortably holding the nebuliser in your hand, place the mouthpiece into
your mouth, alternatively you can use the nose piece or mask. Should you
opt for the mask accessory, place it on your face as shown in the picture
(with or without using the elastic).
6. Switch on the unit (A1) and breathe in and out deeply.
7. When the treatment is finished, switch o and unplug the unit.
8. The aerosol therapy device and accessories should be cleaned after use
according to the Cleaning Instructions.
•
If after the therapy session moisture accumulates in the tube (B), remove the tube from the nebuliser
chamber (C1) and dry it using the compressor air flow; this operation will prevent mould from forming
inside the tube.
RF8 Plus – OPERATION MODES
This nebuliser chamber is professional, fast and suitable to administer all medication.
For a slower flow of
medication, rotate the speed
selector (C1.2.3) anti-
clockwise.
For a faster flow of medication
rotate the speed selector (C1.2.3)
clockwise. However this will result
in some medication escaping into
the environment due to the opening
of valves in the nebuliser.
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USE OF NEBULIZATION MANUAL CONTROL
The manual nebulisation control (C6) can be used to reduce dispersion of the medication into the surrounding
environment and reduces wastage of the medication. It should not be used if continuous nebulisation of the
medication is required, which may be more suited for children and people with reduced capabilities.
CLEANING INSTRUCTIONS
• The casing of this unit is not protected against the penetration of liquids. Do not wash the device under
running water or submerge in water. Keep away from splashing water or other liquids.
Turn o the unit before any cleaning and disconnect the power cord from the mains.
CLEANING THE DEVICE AND THE OUTER SURFACE OF THE TUBE
The device and outer surface of the tube should only be cleaned with a cloth dampened with antibacterial
detergent. The detergent must be non-abrasive and free of solvents.
CLEANING OF THE ACCESSORIES
The accessories must be cleaned before and after each use using one of the methods described below.
1. WASHING
Open the nebuliser by turning the Upper part with valve and speed selector (C1.2) counterclockwise and
disassemble it as shown in the “Assembly Diagram” section C1 and C1.2 then follow one of the three methods
listed below.
(Method A): The accessories that can be washed with method A are (C1.1-C1.2.1-C1.2.2-C1.2.3-
C2-C3-C4-C5-C6)
Wash the accessories in warm drinking water (approximately 40 °C) with mild dishwashing liquid (non
abrasive) or in the dishwasher on a hot cycle.
(Method B): The accessories that can be washed with method B are (C1.1-C1.2.1-C1.2.2-C1.2.3-
C2-C3-C4-C5-C6)
Immerse the accessories in a solution of 60% water and 40% white vinegar. Rinse thoroughly with warm
(approximately 40 °C) drinking water.
(Method C): The accessories that can be washed with method C are (C1.1-C1.2.1-C1.2.2-C1.2.3-
C2-C3-C6)
Wash the accessories by boiling in water for 20 minutes; preferably use demineralized or distilled water to
avoid scale deposits.
After washing shake the accessories vigorously and place them on a paper towel, or dry them with a jet of hot
air (e.g. using a hair dryer).
To start nebulising close the hole of
the manual nebulisation control (C6)
with your finger, breathe in gently; it is
recommended to hold your breath briefly
so that the inhaled aerosol droplets can
be deposited.
To disable nebulising, remove
your finger from the hole of the
manual nebulisation control.
Exhale slowly.
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2. DISINFECTION
If you wish to disinfect these accessories, strictly follow one of the two methods listed below after washing to ensure
eective disinfection.
(Method D): The accessories that can be disinfected with method D are (C1.1-C1.2.1-C1.2.2-C1.2.3-
C2-C3-C4-C5-C6)
The accessories should be disinfected using a sterilizing fluid containing sodium hypochlorite solution or other
appropriate electrolytic oxidizing chlorine disinfectants as recommended by your pharmacist.
• Fill a container, large enough to contain all accessories, prepare the solution by following the instructions provided
with the disinfectant. Completely immerse each individual accessory in the solution. Take care to avoid air bubbles
in contact with the accessories. Leave the accessories immersed for the period of time indicated on the instructions
of the disinfectant.
• Remove the disinfected accessories rinse thoroughly with lukewarm drinking water.
• Dispose of the solution as recommended by the disinfectant instructions.
(Method E): The accessories that can be disinfected with method E are (C1.1-C1.2.1-C1.2.2-C1.2.3-
C2-C3-C6)
Disinfect the accessories by boiling in water for 20 minutes; preferably use demineralized or distilled water to avoid
scale deposits.
After disinfection shake the accessories vigorously and place them
on a paper towel, or dry them with a jet of hot air
(e.g. using a hair dryer).
Re-assemble the nebuliser chamber as shown in the
Assembly Diagram section C1 and C2.
Warning: The arrow shown on the valve retainer
(C1.2.2) should be aligned with the accessory
connection port (see picture). This will ensure an
accurate fit into the upper part (C1.2.1).
AIR FILTER
The unit is equipped with an air filter (A3) which should be replaced when dirty
or when its colour changes. To replace the filter take it out by pulling it as shown
in the diagram.
Use only Alvita original accessories.
Use by another person
Before use by another person the device should be cleaned using the instructions provided and the
accessories (B, C1-6) and air filter (A3) should be replaced.
Replacement accessories are available from your pharmacist.
C1.2.1
C1.2.2
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IMPORTANT SAFEGUARDS
• It is recommended that this device is only used by a single person to avoid any risk of infection.
• Children and disabled persons should always use the unit under strict supervision of an adult who has
read this manual.
• Several parts of the device are small enough to be swallowed by children; therefore store the device out
of reach of children.
• Do not use the tubes and the cords of the device for purposes other than those specified as they may
cause strangulation hazard; attention must be paid to children and people incapable of assessing the
risk.
• Keep the cord away from heated surfaces.
• Keep the power supply cord away from animals (for example rodents) as they may damage the insulation
of the power supply cord.
• Do not use this device in humid, wet or extreme temperatures.
• Do not put the device store heat sources or in direct sunlight.
• Do not use this device in the bath or shower; do not immerse in water.
• If your device accidentally becomes immersed in water, do not remove or touch the device before pulling
out the plug. Contact Alvita using the details provided at the bottom of this leaflet.
• During use, always place the unit on a firm surface clear of obstacles.
• Check that there is no material obstructing the air vents before each use.
• Do not obstruct or insert any objects in the filter or in its housing.
• Do not obstruct or place any objects in the air vents of the unit.
• The average operational life of the compressor is 700 hours.
• The average lifespan of accessories is 1 year; however, we recommend you replace the nebuliser every 6
months in intensive use (or earlier, if the nebuliser is blocked) to always ensure maximum therapeutic
eect.
• Do not modify this equipment without authorization of the manufacturer.
• Repairs must be performed by authorized personnel only. Any unauthorized repairs will void the warranty
and may pose a safety hazard for the user.
• The Manufacturer is responsible for the safety, reliability and performance of the device only if:
a. the device is used in accordance with the operating instructions
b. the electrical system of the premises where the device is used is in compliance with current laws.
• Interactions: The materials used that come into contact with medications have been tested with a wide
range of medications. However, due to the variety and continuous evolution of medication, the possibility
of a chemical interaction cannot be excluded. We recommend that once the medication has been opened
you should use it as soon as possible and avoid prolonged contact of the medication with the nebuliser.
• The manufacturer should be contacted for reporting problems and/or unexpected events related to device
operation.
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TECHNICAL FEATURES
Mod.: T2000
Voltage:
Max pressure:
Compressor air output:
Sound level (at 1 m):
Operation:
In conformity with:
Dimensions (W)x(D)x(H):
Weight:
Applied parts
Type BF applied parts are:
Operating conditions:
Temperature: min 10°C; max 40°C
RH Air humidity: min 10%; max 95%
Atmospheric pressure: min 69KPa; max
106KPa
Storage conditions:
Temperature: min -25°C; max 70°C
RH Air humidity: min 10%; max 95%
Atmospheric pressure: min 69KPa; max
106KPa
RF8 Plus Nebuliser
Medication
minimum capacity
ml
Medication
maximum capacity
ml
(1) Operating
pressure
bar (approx)
(1) Delivery
ml/min (approx)
(2)MMAD
μm
(2)Breathable
fraction < 5 μm
%
2 8 1,3 max min max min max min
0.44 0.28 4.12 3.69 59.8 64.2
(1) Values measured according to Flaem’s internal procedure I29-P07.5 Delivery rate values can change depending on the patient’s respiratory capacity.
(2) In vitro testing certified by TÜV Rheinland LGA Products GmbH – Germany in compliance with the European Standard EN 13544-1 for nebulising
systems. Further details available on request.
DISPOSAL OF DEVICE
In conformity with Directive 2002/96/EC, the symbol shown on the device to be disposed of indicates that it is considered as waste and is therefore subject to
“sorted waste collection”. The user must therefore take (or have taken) the above waste to a pre-sorted waste collection centre set up by the local authorities,
or else give it back to the dealer when purchasing a new appliance of the same type. Pre-sorted waste collection and the subsequent treatment, recovery
and disposal operations favor the production of appliances made of recycled materials and Iimit the negative eects of any incorrect waste management on
the environment and public health. The unlawful disposal of the product by the user could result in administrative fines as provided by the laws transposing Directive
2002/96/EC of the European member state or of the country in which the product is disposed of.
ELECTROMAGNETIC COMPATIBILITY
This device has been designed to meet the current requirements for electromagnetic compatibility (EN 60601-1-2:2007). Electromedical devices require special care
during installation and use with respect to EMC requirements, it is therefore required that they be installed and/or used according to the manufacturer’s specification.
Potential risk of electromagnetic interference with other devices, in particular with other devices for analysis and treatment. Radio and mobile or portable RF
communications devices (mobile phones or wireless connections) may interfere with the operation of electromedical devices. For additional information please visit
www.flaemnuova.it. The Manufacturer reserves the right to make technical and functional changes to the product without notice.
Class II device
Important: check the operating instructions
“OFF” for part of equipment
“ON” for part of equipment
Complies with: European standard EN 10993-1 “Biological
Evaluation of Medical Devices” and European Directive 93/42/EEC
“Medical Devices”
Keep dry
Type BF applied part
Alternating current
Hazard: electrocution.
Consequence: Death.
Do not use device while taking a bath or shower
CE Medical Marking ref. Dir. 93/42 EEC and
subsequent amendments.
Complies with EN 60601-1-11
Manufacturer
Serial number of device
SYMBOLS
230V ~ 50Hz 140VA
2.6 ± 0.4 bar
10 l/min approx
54 dB (A) approx
continuous
21x16x11 cm
1.45 Kg
Patient accessories (C2,C3,C4,C5)
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Flaem Nuova S.p.A.
Via Colli Storici, 221, 223, 225
25015 S. MARTINO DELLA BATTAGLIA
(Brescia) - ITALY
Vertrieb durch: Alvita®Kundenservice Deutschland, Telefon [phone]
Distributed by: Alvita®Nederland, Postbus 474, 5201 AL ’s-Hertogenbosch
Distributed by: Alvita®UK, 43 Cox Lane, Chessington, Surrey KT9 1SN
Distribué par : Alvita®France, (tel. [phone])
ALV4616/2
PIP CODE 386-6415
Cod. 16238A0 Rev. 12/2014
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