Intended Use; Product Description; Important Notices - FLAEM Aspira Instrucciones Para El Uso

Mod. P1211EM/11 l - Mod. P1211EM/13.5 l - Mod. P1211EM/20 l
We are pleased you have purchased our product and we thank you for your trust in us.
It is very important that the health care worker, the person trained in use or the patient read and understand

INTENDED USE

ASPIRA is an aspirator designed for medical and surgical use in healthcare centres such as hospitals, for home care and for
pharyngeal suction for permanent tracheotomy. The device generates a negative pressure (suction) which allows fluids
to be extracted through a single use tube connected to a collection canister which retains the fluids until they can be
properly disposed of. Use of the device must be prescribed by a doctor.

PRODUCT DESCRIPTION

ASPIRA (1) is equipped with vacuum level adjustment knob (4), vacuum gauge (3) and 1000 ml or 800 ml canister (9) with
overflow safety device (10) to prevent fluids from entering the suction pump. This device interrupts the suction flow via
a float-controlled valve housed in the canister lid. It does not require lubrication, is manageable, simple to use, reliable,
resistant and noiseless. ASPIRA is equipped with the following FLAEM accessories: 1000 ml or 800 ml canister (9) with
overflow safety device (10), connection tubing (6/8/14), single use antibacterial/antiviral hydrophobic filter (7), single use
aspirator tube (16), single use manual vacuum flow control (15).
NOTE: Only use original FLAEM accessories and spare parts, we disclaim any liability in the event of using non
original spare parts or accessories.
DEVICE NOMENCLATURE
1) SUCTION MACHINE
2) ON/OFF SWITCH
3) VACUUM GAUGE
4) VACUUM FLOW ADJUSTMENT KNOB
5) AIR INLET
6) CONNECTION TUBING
7) HYDROPHOBIC
ANTIBACTERIAL/ANTIVIRAL FILTER (SINGLE USE)
8) CONNECTION TUBING
9) COLLECTION CANISTER
- ALTERNATIVE STERILISABLE MODEL
- SINGLE PATIENT MODEL

IMPORTANT NOTICES

The manufacturer makes every effort to ensure that every product is of the highest quality and safety; however, as for
any electrical device, basic safety regulations must always be followed in order to avoid harming persons and things.
• The medical device must NOT be used in the operating theatre, for drainage or for thoracic drainage or on ve-
hicles such as ambulances or emergency vehicles.
• The Medical Device is not suitable for use in MRI premises (Magnetic Resonance Imaging)
• Carefully follow the user and maintenance instructions to assure proper operation and to extend the service life of the
device.
• The supplied cable is equipped with a protective gasket to prevent the penetration of liquids into the device. Do not
separate this gasket from the cable.
• Before using the product for the first time, and periodically during its lifetime, check the power cable to make sure it
is not damaged. In the event it should be damaged, do not plug in the cable and immediately bring the product to an
authorised FLAEM service centre or to your trusted dealer.
• In the presence of children and non self-sufficient individuals, the device must be used 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; keep the device out of the reach of children.
• Do not use the provided tubing and cables for any other purpose than those specified, as they can cause risk of stran-
gulation. Be particularly attentive with children and individuals with disabilities because they are often unable to cor-
rectly assess risk.
• The suction machine is intended exclusively for the collection of NON-flammable fluids. It is not suitable for use in the
presence of a flammable anaesthetic mixture with air, or with oxygen or nitrous oxide.
• Always keep the power cable away from hot surfaces.
• Keep the power cable away from animals (for example, rodents) which could damage the insulation.
• Do not handle the plug with wet hands. Do not use the device in damp conditions (for example when 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 first. Immediately bring the device to an authorised
the information for use and maintenance.
10) SAFETY DEVICE
11) CANISTER LID
12) CANISTER "VACUUM" INLET
13) CANISTER "PATIENT" INLET
14) CONNECTION TUBING
15) MANUAL VACUUM
FLOW CONTROL
16) ASPIRATOR TUBE
17) POWER CABLE
10