nuVita P0207EM F400 User manual

Nuvita 5022
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 oering 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.
THIS DEVICE COMES EQUIPPED WITH:
A - Aerosol Therapy Device
A1 - Switch
A2 - Air outlet port
A3 - Air lter
A4 - Nebulizer port
A5 - Carrying handle
A6 - Power cord
C - Accessories
C1 - RF7 Dual Speed Nebulizer
C1.1 - Bottom piece
C1.2 - Nozzle
C1.3 - Top piece
C1.4 - Speed selector
C2 - Mouthpiece
C3- Child nasal inhaler
C4 - SoftTouch Adult mask
C5 - SoftTouch Pediatric mask
IMPORTANT SAFEGUARDS
• 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 service centre or to your trusted dealer.
• Should your device fail to provide the expected performance, contact the authorised
service centre for clarications.
• The expected medical life of the accessories is 1 year. It is, however, advisable to replace
the nebuliser cup every 6 months in the event of intense use (or earlier if the cup is
obstructed) to always guarantee maximum therapeutic ecacy.
• Children and people who are not self-sucient 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 diculties 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 nothandle thedevicewithwet hands.Do notuse thedevicein dampenvironments(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 service centre or to your trusted dealer.
ENGLISH
B - Connection tube (main unit / nebulizer)
A
B
C
A3
A4
A5
A2
A1A6
C1.4
C1.3
C1.2
C1.1
C1
User manual Aerosol therapy unit
Schema di collegamento • Croquis de conexiones • Assembly diagram

• 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.
• Do not put any objects in the air vents.
• Repairs, including the replacement of the supply cord, are to be carried out by Nuvita
authorised personnel only, by complying with the information provided by the
manufacturer.
• The average expected duration for the compressor is: 400 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
nebuliser cup.
• The manufacturer must be contacted about any problems and/or unexpected events
concerning operation and for any clarications 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.
OPERATING INSTRUCTIONS
Before each use, clean hands thoroughly and clean the device as described in the
section on“CLEANING, SANITIZATION AND DISINFECTION”. During use, it is advisable
to protect yourself from any dripping. It is recommended that each person use their
own nebulizer cup and accessories to prevent risk of infection due to contamination.
This device is suitable for the administration of medical substances and not, for
which the administration via aerosol is foreseen; these substances are to be in any
case prescribed by the Doctor. In case of too thick substances, the dilution with a suit-
able physiological solution could be needed, according to the medical prescription.
1. Plug the power cord (A6) into a power socket corresponding to the voltage of the unit.
This must be positioned so that it is not dicult to make the disconnection from the
mains.
2. Insert the nozzle (C1.2) in the upper part (C1.3) pressing as shown by the 2 arrows in the
“Connection diagram”in point C1. Insert the Speed selector (C1.4) in the upper part (C1.3)
as shown in the “Connection diagram” in point C1. Pour the medication prescribed by
the doctor into the lower part (C1.1). Close the nebuliser by turning the upper part (C1.3)
clockwise.
3. Connect accessories as indicated in the“Connection diagram”on the cover.
4. Sit comfortably holding the nebuliser in your hand, place the mouthpiece onto your
mouth or alternatively 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 elasticated
strap).
5. Turn on the device using the switch (A1) and then breathe
in and exhale deeply.
6. When the treatment is nished, shut o the device and
unplug the power cord.
WARNING: If after the therapy session moisture accumulates
in the tube (B), remove the tube from the nebulizer and
dry it using the device’s compressor fan; this operation will prevent mold from forming
inside the tube.
SoftTouch masks have an outer edge made of soft
biocompatible material that ensures excellent ad-
herence to the face, and is also equipped with an
innovative Dispersion Limiting Device. These dis-
tinctive elements that distinguish it allow greater
sedimentation of medication in the patient and also
limit dispersion.
During the inspiratory phase, the
tab, acting as a Dispersion Lim-
iting Device, bends inwards to-
wards the mask.
During the expiratory phase, the
tab, acting as a Dispersion Limit-
ing Device, bends outwards from
the mask.
HOW TO USE THE“RF7 DUAL SPEED”NEBULIZER WITH THE SPEED SELECTOR
Professional and fast, this device is suitable for administering all types of medications,
including more expensive ones,even in patients with chronic diseases. The geometry
of the internal lines of the RF7 Dual Speed nebulizer ensures the ideal granulometry for
active treatment all the way down to the lower respiratory tract.
To speed up the inhalation therapy, move the speed selector button
(C1.4) by pressing on MAX with your nger.
To increase the eectiveness of the inhalation therapy, press with your
nger on the wording MIN of the speed selector (C1.4). In this position,
the speed selector acts as a valve and allows nebulizing the optimal
amount of drug to the lower respiratory tract, reducing its dispersion in
the environment.
SOFTTOUCH FACE MASKS
Soft
biocompatible
material
Dispersion
Limiting Vent

CLEANING SANITISATION DISINFECTION
Switch o the device before any cleaning procedure and unplug the power cable from the socket.
DEVICE AND TUBING EXTERIOR
Use only a damp cloth with antibacterial soap (non-abrasive and with no solvents of any
sort).
ACCESSORIES
Open the nebuliser by turning the upper part (C1.3) anticlockwise, remove the nozzle
(C1.2) from the upper part (C1.3) by pressing as shown by the 2 arrows in the "Connection
diagram" in point C1. Then proceed according to the following instructions.
SANITISATION
Before and after each use, sanitise the nebuliser cup and the accessories, choosing one of
the methods described below.
method A: Sanitise accessories C1.1-C1.2-C1.3-C1.4-C2-C3-C4 -C5 under potable hot
water (approximately 40°C) with a gentle, non abrasive dish detergent.
method B: Sanitise accessories C1.1-C1.2-C1.3-C1.4-C2-C3-C4 -C5 in the dishwasher with
a hot cycle.
method C: Sanitise accessories C1.1-C1.2-C1.3-C1.4-C2-C3-C4 -C5 by immersing them in
a solution of 50% water and 50% white vinegar, then rinse thoroughly under potable hot
water (approximately 40 °C).
If you want to also perform the cleaning for DISINFECTION, jump to the DISINFECTION
paragraph.
After having sanitised the accessories, shake them vigorously and place them on a paper
towel. Alternatively, dry them with a jet of hot air (for example, a hair dryer).
DISINFECTION
After sanitising the nebuliser cup and the accessories, disinfect them choosing one of the
methods described below.
method A: Accessories C1.1-C1.2-C1.3-C1.4-C2-C3-C4 -C5 can be disinfected.
The disinfectant must be an electrolytic chloroxidizer (active principle: sodium
hypochlorite) specic for disinfecting, which is available in any pharmacy.
Implementation:
- Fill a container big enough to hold all of the parts to disinfect with a solution of potable
water and disinfectant, according to the proportions indicated on the packaging of the
disinfectant.
- Completely immerse each part in the solution, taking care to avoid the formation of air
bubbles on the parts. Leave the parts immersed for the amount of time indicated on the
packaging of the disinfectant associated with the concentration chosen for the solution.
- Remove the disinfected parts and rinse abundantly with warm potable water.
- Dispose of the solution following the instructions provided by the disinfectant
manufacturer.
method B: Sanitise the accessories C1.1-C1.2-C1.3-C1.4-C2-C3-C4 -C5 by boiling them
in water for 10 minutes; use demineralised or distilled water to prevent calcium deposits.
method C: Sanitise the accessories C1.1-C1.2-C1.3-C1.4-C2-C3-C4 -C5 with a hot steam
steriliser for baby-bottle (not the microwave type). Perform the process faithfully following
the instructions of the steriliser. To ensure that the disinfection is eective, choose a
steriliser with an operating cycle of at least 6 minutes.
After having disinfected the accessories, shake them vigorously and place them on a
paper towel. Alternatively, dry them with a jet of hot air (for example, from a hair dryer).
At the end of each use store the device complete with accessories in a dry place away
from dust.
REPLACING THE FILTER
The device has a suction lter (A3) that should be replaced when it is dirty or
changes color. Do not wash or reuse the same lter. Regular replacement of the
lter is required to help and ensure correct performance of the compressor.
To replace the lter:
Insert a athead screwdriver between the edge of the lter and the body. Lift the
lter and remove it by turning and pulling it. The lter has been designed so that
it is always xed in its seat. Do not replace the lter during use.
Only use original accessories and spare parts, we disclaim any liability in
the event of using non original spare parts or accessories.
TROUBLE-SHOOTING
Switch o the device before any procedure and unplug the power cable from the socket.
PROBLEM CAUSE SOLUTION
The device does not work
The power cable has not been
correctly inserted into the socket
of the device or the power socket
Correctly insert the power cable
in sockets.
The device does not
nebulize or
nebulizes insuciently.
The medication has not been
inserted in the nebulizer
Pour the right amount of
medication
in the nebulizer
The nebulizer has not been
properly tted.
Disassemble the nebulizer and
reassemble it correctly as shown
in the connection diagram on
the cover.
The nebulizer nozzle is
clogged
Disassemble the nebulizer,
remove the nozzle and perform
cleaning operations Failure to
remove medication deposits
from the nebulizer aects its
eciency and operation.
Strictly comply with the
instructions contained in the
“ CLEANING, SANITISATION,
DISINFECTION” chapter
The air pipe is not correctly
connected to the device
Ensure the device’s accessories
are properly connected to the air
intake (see connection diagram
on the cover).
The air pipe is bent, damaged
or twisted
Unwind the pipe and ensure it is
not crushed or punctured. If
necessary replace it.
The air lter is dirty Replace the lter
The apparatus is noisier
than usual
The Filter is not correctly
inserted in its housing
Fully and properly insert the
Filter in its housing
If after verifying the above mentioned conditions the device should not operate
properly, contact your trusted retailer or the nearest authorized service center.

SYMBOLS
Certication TÜV
CE Medical Marking ref. Dir. 93/42
EEC and subsequent amendments Serial number of device
Class II device Manufacturer
Important: check the operating
instructions Type BF applied part
“OFF”for part of equipment Alternating current
“ON”for part of equipment
Hazard: electrocution.
Consequence: Death.
Do not use device while taking a bath
or shower
Complies with: European standard
EN 10993-1“Biological Evaluation
of Medical Devices”and European
Directive 93/42/EEC“Medical
Devices”. Phthalates free. In
conformity with Reg. (EC) no.
1907/2006
IP21
Enclosure protection rating: IP21.
(Protected against solid bodies over
12 mm. Protected against access with
a nger;
Protected against vertically falling water
drops.)
Minimum and maximum room
temperature Minimum and maximum air moisture
Minimum and maximum
atmospheric pressure
ELECTROMAGNETIC COMPATIBILITY
This device was designed to satisfy the currently required requisites for electromagnetic
compatibility (EN 60601-1-2:2015). Electro-medical devices require particular care during
installation and use relative to EMC requirements. Users are therefore requested to install
and/or use these devices following the manufacturer's specications. There is a risk of
potential electromagnetic interference with other devices. RF mobile or portable radio and
telecommunications devices (mobile telephones or wireless connections) can interfere
with the functioning of electro-medical devices. The Medical Device may be subject to
electromagnetic interference if other devices are used for specic diagnosis or treatments.
For further information visit our website www.nuvitababy.com. The Manufacturer reserves
the right to make technical and functional modications to the product with no prior
warning.
TECHNICAL FEATURES
Nuvita 5022 (Mod.: P0207EM F400)
Voltage: 230V~ 50Hz
130VA 115V ~ 60Hz 220V ~ 60Hz
Safety certications:
Max pressure:
Compressor air output:
Sound level (at 1 m):
Operation:
1.8 ± 0.3 bar
9 l/min approx
54 dB (A) approx
Continuous use
Operating conditions:
Temperature:
R H Air humidity:
Atmospheric pressure:
min 10°C; max 40°C
min 10%; max 95%
min 69KPa; max 106KPa
Storage conditions:
Temperature:
R H Air humidity:
Atmospheric pressure:
min -25°C; max 70°C
min 10%; max 95%
min 69KPa; max 106KPa
Dimensions (W)x(D)x(H):
Weight:
16x16x13 cm
1.300 Kg
APPLIED PARTS
Type BF applied parts are: patient accessories (C2, C3,C4, C5)
RF7 Dual Speed nebulizer
Medication minimum capacity:
Medication maximum capacity:
Operating pressure (with neb.):
2 ml
8 ml
0.65 bar
Speed selector C1.4
Max Min
(1) Delivery: 0.55 ml/min approx. 0.25 ml/min approx.
(2) MMAD: 4.58 μm 3.78 μm
(2) Breathable fractions < 5 μm (FPF): 54.4% 63%
(1) data detected according to I29-P07.5 internal procedure
(2) In vitro testing certied by TÜV Rheinland LGA Products GmbH - Germany in compliance with the European
Standard EN 13544-1 for nebulising systems. Further details are available upon request.
DEVICE DISPOSAL
In compliance with the Directive 2012/19/EC, the symbol printed on the device
shows that the device to be disposed of is considered waste and must therefore
be an item of ''dierentiated collection''. Consequently, the user must take it (or
have it taken) to the designated collection sites provided by the local authorities,
or turn it in to the dealer when purchasing an equivalent new device. Dierentiated
waste collection and the subsequent treatment, recycling and disposal procedures
promote the production of devices made with recycled materials and limit the
negative eects on the environment and on health caused by potential improper
waste management. The unlawful disposal of the product by the user could result
in administrative nes as provided by the laws transposing Directive 2012/19/EC of
the European member state or of the country in which the product is disposed of.

WARRANTY - TERMS AND CONDITIONS
This product benets of a warranty of 24 months on material and manufacturing defects,
starting from the date of purchase (see sales slip).
The warranty of 24 months does not include damages caused by the usual use of parties
identied as "consumable" (e.g., batteries, brush heads or parts subject to usury).
The legal guarantee of 24 months is void if:
The following is excluded from the legal guarantee of 24 months:
The manufacturer, distributor and all the parties involved in the sale do not assume
any liability for losses and economic damage from any malfunction of the product. In
accordance with current regulations the manufacturer, distributor and all the parties
involved in the sale are not responding in any case for damages, including direct,
indirect ones, loss of net income, loss of savings and additional damage and other details
consequences going beyond the damage caused by the breach of warranty, contract,
strict liability, wrongdoing or due to other causes, resulting from the use or inability to
use the product and/or paper and electronic documents, including the lack of service.
For further information on the help service visit the website www.nuvitababy.com
1.
2.
3.
1.
2.
3.
4.
5.
The product has undergone aesthetic damage due to improper use not in accordance
with instructions in the manual.
This product has been modied and/or tampered with.
The cause of the failure was due to poor maintenance of the individual components
and/or accessories and/or supplies (e.g. oxidation and/or scaling due to the retention
of water or other liquids, sediment blocking the sensor, leak of corrosive liquid from
batteries).
Costs related to replacements and/or repair of parts subject to wear or costs for
ordinary maintenance of the product.
The costs and risks involved in transporting the product to and from the store where
you purchased or otherwise authorized collection centre to receive the products under
warranty.
Damage caused by or resulting from improper installation or improper use not in
accordance with the directions in the instruction manual.
Damage due to natural disasters, accidental events or adverse conditions not
compatible with the product.
Defects that have a negligible eect on product performance.
cod.18428 -Rev 09/2018
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