Flaem Smarty Manuale

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

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 oering 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

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

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

ENGLISH

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 clarications.

• Repairs must be performed by authorised FLAEM personnel only, by

complying with the information provided by the manufacturer. Any

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 dierent 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 clarications

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.

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.

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.

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.

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

4 - OPERATION

For eective 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

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 eectiveness 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.

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.

PUSH

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).

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.

5.7 Carefully clean it according to the CLEANING, SANITISATION, DISIN-

FECTION instructions in paragraph 6.

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