Flaem Smarty Manual

Assembly diagram - Anschlussschema -Sché-
ma de montage - Verbindingsschema - -Cro-
quis de conexiones- Schemat połączeń dla
nomenklatury
INSTRUCTIONS
FOR USE
MANUAL
MODE
D’EMPLOI
GEBRUIKS-
AANWIJZING
BEDIENUNGS-
ANLEITUNG
MANUAL DE
INSTRUCCIO-
NES DE USO
PODRĘCZNIK
INSTRUKCJI
OBSŁUGI
ENGLISH
Page 2
FRANÇAIS
Page 38 DEUTSCH
Seite 20
NEDERLANDS
Page 56
ESPAÑOL
Página 74
РOLSKI
Strona 92

2
WARNING
TO PREVENT DAMAGE TO THE MESH,
CAREFULLY FOLLOW STEPS 1 TO 4 AS LISTED BELOW
Thank you for your purchase. Our goal is the complete satisfaction of our
customers by oering cutting-edge products for the prevention and
treatment of the respiratory tract ailments.
Visit our website www.aem.it to view the whole range of Flaem’s products.
Read these instructions carefully in order to use the device correctly.
We recommend that you store this manual for future consultation.
Smarty is a medical device for home use to nebulise and administer
medication
Portable device
for aerosol therapy using
the latest in PMVT technology
(Passive MESH Vibrating Technology)
1 2 3 4
Intended use: this is an electronic Medical Device for aerosol therapy.
Smarty is suitable for nebulising medications which are either in solution
eg mucolytics, or suspension eg corticosteroids such as beclomethasone
dipropionate and budesonide) and saline solution, prescribed or
recommended by your doctor upon assessing the patient’s general
conditions. This unit may be used in medical facilities (hospitals, clinics etc.)
and at home.
For more information, a video tutorial is available at smarty.aem.it

3
DEVICE COMPONENTS
1- Main Unit
2- Removable
medication chamber
2G- Nebuliser
head
3- Mouthpiece 4- Child mask 5- Adult mask
6 - 2 1.5V AA
alkaline batteries
2F
2E
2D
2B
1A
1B
1A - ON DEMAND nebulisation button
1B - CONTINUOUS nebulisation
START AND STOP button
1C - Medication chamber release button
2A - Medicine cup
2B - Nebulising chamber
2C - Medication cup locking clip
2D -Medication cup cover
2E - Nebulising chamber and
Medication cup release clips
2F -Accessories connection port
2A
1C
2C
ENGLISH

4
IMPORTANT WARNINGS
• As with any electrical device, especially in the presence of children, the
use of Smarty requires some basic safety precautions.
• The device should not be used as a toy. Please take particular care when it
is used by children.
• If the device is used by or in the presence of children or people who
require special assistance, the supervision of an adult who has read this
manual is necessary.
• This product must not be used by unconscious patients or not breathing
spontaneously
• Some parts of the device are small enough to be swallowed by children;
keep the device out of reach of children.
• Never use batteries other than those recommended in this manual.
• Use only batteries of known brands. Always replace both with new ones
and do not mix new and old batteries. AA alkaline or Lithium batteries
and rechargeable Ni-Mh can be used. Rechargeable batteries shall be
charged using a battery charging device that is not supplied with this
device.
• The average battery life depends on the brand used.
• It is very important to use batteries of the same brand and same type.
• Remove the batteries before storing the unit when it is not used for long
periods.
• Smarty should not be used in the presence of an anaesthetic mixture
which is ammable with oxygen or nitrous oxide.
• The device housing has been designed for limited contact with
liquids (no immersion). Do not wash the device under running water
or by immersion. Carefully follow the "CLEANING, SANITISATION,
DISINFECTION" in this manual. Absolutely do not use alcohol to clean
the device
• Do not use the device while taking a shower or a bath.
• Do not operate the device while driving or in any other situation where a
distraction could be dangerous for the user, for close people or animals or
surrounding objects.
• Do not expose the device and the batteries to extreme temperatures.
Keep the device and batteries away from heat sources, direct sunlight or
excessively hot and humid environment.
• The average duration for the device used for about 20 min a day with
medicinal products (4 applications of 5 min) is set out below:
- Main unit 5 years
- Masks and Mouthpiece 5 years
- Medication chamber 1 year
- Nebuliser head 1 year (Component subject to wear)
• Should your device fail to provide the expected performance, contact the
authorised service centre for clarications.
• Repairs must be performed by authorised FLAEM personnel only, by
complying with the information provided by the manufacturer. Any

5
unauthorized repairs will void the warranty and may pose a safety hazard
for the user.
• WARNING Do not modify this device without authorisation of the
manufacturer.
• The manufacturer, importer and seller will be held responsible for the
safety, reliability and performance, only if the device is used in accordance
with the instruction manual.
• Interactions: the materials used have been tested according to the
standards of biocompatibility (ISO 10993-5 and ISO 10993-10) in
compliance with the essential requirements of the 93/42 EEC Medical
Device Directive. The materials used in the 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.
• If the device is used with dierent medications, it is recommended to
remove all residues. Therefore, clean it after each treatment so as to obtain
the highest degree of hygiene and to optimise the life and operation of
the device
• The device does not contain parts to be repaired by the user. The warranty
does not cover batteries or damage caused by incorrect, used up or
improperly stored batteries.
• The manufacturer should be contacted for reporting problems and/or
unexpected events related to device operation, and for any clarications
on use, maintenance/cleaning.
• Only use original accessories and spare parts by Flaem, we disclaim any
liability in the event of using non original spare parts or accessories
OPERATING INSTRUCTIONS
1 - BATTERY INSTALLATION
1.a Use a small coin to open the Battery
Compartment cover (1D) located
on the bottom of the unit.
1D

6
2 - PREPARATION
WARNING!
Before each use, the unit and the accessories should be cleaned and/or dis-
infected according to the DISASSEMBLY, CLEANING, SANITISATION, DISIN-
FECTION instructions (paragraph 5/6)
We recommend personal use, both of the nebuliser and accessories to avoid
possible risk of infection. Use only FLAEM original accessories.
2D
2C 2A
Wash your hands thoroughly before
preparing the medication
2.1 Lift the locking clip (2C) of the
Medication cup cover (2D)
2.2 Open the Medication cup cover
(2D) completely
2.3 Pour the medicine (MAX 8 ml) into
the Medication cup (2A)
2.4 Close the Medication cup cover
(2D)
2.5 Fasten the locking clip (2C)
WARNING!
After pouring the medicine into the
Medication cup (2A), the medicine
must be nebulised.
+
+
-
-
1D
6
1E
1.b Insert the two AA batteries (6),
in the Battery Compartment
(1E), making sure that the polar-
ity is correct.
1.c Close the Battery Compartment
Cover (1D) making sure that the
cover is properly.

7
3.1 Connect the desired accessory to
the Accessories connection port
(2F):
- Mouthpiece (3)
- Child mask (4)
- Adult mask (5)
If a mask is used, place it on the face as
shown in the picture
2F
5
4
3
4 - OPERATION
1A
1B
For eective therapy, after setting the appliance
up, sit in a comfortable and relaxed position and
proceed. Select the preferred delivery mode (“ON
DEMAND”or “CONTINUOUS”)
4.1 By pressing buttons (1A-1B) they light up as
follow:
FLASHING BLUE: for a few seconds, until a
complete initialization of device.
STEADY BLUE: nebulisation
FLASHING RED: batteries are used up; re-
place with new batteries of the same type
4.2 ON DEMAND button (1A) Press this button
when inhaling to obtain the delivery of medi-
cation without waste. The device only works
if you hold down the button, which will turn
blue.
4.3
START AND STOP / CONTINUOUS button
(1B): Press this button to obtain the “CONTIN-
UOUS” delivery of medication (fast treatment).
3 -
UNIT CONFIGURATION

8
1A
1B
To switch o the unit, press the button (1B)
again.
4.4 Sit comfortably holding the device in your
hand, place the Mouthpiece (3) in your
mouth then breath in and out slowly through
the mouth. Alternatively, you can use the
Child Mask (4) or the Adult Mask (5).
4.5 To increase the eectiveness of treatment,
breathe slowly and deeply and after inhaling
hold your breath for a moment, so that the in-
haled medicine can deposit along the respira-
tory tract. Then exhale slowly.
4.6 The unit turns o automatically:
4.6.a after 5 minutes of use
4.6.b when, during use, the medication
chamber (2) is accidentally removed .
4.7 If you do not use the appliance for a pause
longer than 5 minutes, place it down on a
surface as shown in the picture. At the end of
each use store the device complete with ac-
cessories in a dry place away from dust.
When treatment is nished proceed as indicat-
ed in paragraphs 5 and 6.

9
5.3 To access the Nebuliser head (2G) in the Nebulising chamber(2B) re-
lease the Medication cup locking clip and open the Medication cup
cover (2D).
5.4 Press simultaneously the two release clips (2E) on both sides of the Med-
ication chamber.
5.5 Rotate until the Nebulising chamber (2B) opens completely.
5.6. Remove the nebuliser head (2G), while at the same time pressing the side
ns.
1C
2
2E
2E
2B
2D
2C
PUSH
PUSH
PUSH
2C
2E
2D
2E
2B
5 - DISASSEMBLY
When treatment is nished:
5.1 Press the Medication chamber release button (1C) positioned on the
back of the unit.
5.2 Remove the Medication chamber (2).

10
WARNING
• Do not use tools: this may cause irreparable damage to the Nebuliser
head (2G).
• Do not press the centre of the Nebuliser head (2G) with your ngers or
tools from the inside: this may cause irreparable damage.
OK
5.7 Carefully clean it according to the CLEANING, SANITISATION, DISIN-
FECTION instructions in paragraph 6.
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