ARIA 200 BAR Compressed medical gas

Зміст інструкції

1. ARIA MEDICAIR 200 bar compressed medical gas
2. ARIA MEDICAIR compressed medical gas is packaged in cylinders and cylinder packs, in

ARIA MEDICAIR 200 bar compressed medical gas

Pharmacotherapeutic category
Pure medical gases and gas mixtures

Therapeutic indications

• In resuscitation for ventilatory support;
• In conditions of chronic respiratory failure to provide respiratory assistance;
• In anesthesia as a carrier gas for volatile anesthetics;
• In nebulizer therapy as a carrier for pharmaceutical substances;
• In the management of immunocompromised patients, such as in cases of organ transplantation, cell transplantation or extensive burns;
• In incubators to provide controlled quality air flows;
• For cavity insufflation.

Contraindications
Medical air is contraindicated where only pure oxygen or other
gas mixtures are indicated (however containing oxygen ≥ 21%).

Precautions for use
Medical air must be administered to patients only at atmospheric pressure or at slightly positive pressures in the case of using ventilators. The administration of medical air under
pressure can cause decompression sickness (as a result of the effects of nitrogen) and
oxygen toxicity.
If medical air is mixed with other gases for inhalation, the oxygen fraction in the
inhaled gas mixture (inhaled oxygen fraction – FiO ) must be maintained at least at
21%. In practice, this means that if medical air is a component of a gas mixture,
oxygen must be one of the other components.
During use at exceptionally high flow rates, such as during use in an incubator,
medical air may be perceived as cold.
Preliminary and during the intake of the medicine, strict adherence to the
safety precautions reported below is required.

Interactions
In general, no interactions with other drugs, or with alcohol, tobacco and
foods have been observed.

Special warnings
It is important to remember that air itself is not flammable, but oxygen (as an oxidizer)
supports combustion; it can, therefore, activate combustion in the presence of combustible
substances such as fats (oils, lubricants) and organic substances (tissues, wood, paper, plastic
materials, etc.) due to an ignition source (spark, open flame, ignition source), or
due to adiabatic compression that can occur in pressure reducing equipment (reducers) during a sudden drop in gas pressure.

• Medical air cylinders must be kept away from heat sources, due to the combustibility of oxygen: appropriate precautions must therefore be taken.
• Oxygen can cause the sudden ignition of incandescent materials or embers; for this reason, smoking or keeping open and unprotected flames near the cylinders and delivery systems is not permitted.
• Do not smoke in the environment where medical air is administered.
• Do not place cylinders near heat sources.
• No electrical equipment that can emit sparks should be used near patients receiving medical air.
• It is strictly forbidden to intervene in any way on the cylinder connections, on the delivery equipment and its accessories or components.
• Any contact with oil, grease or other hydrocarbons must be avoided ( OIL AND GREASECAN SPONTANEOUSLY IGNITE ON CONTACT WITH OXYGEN).
• It is strictly forbidden to handle equipment or components with hands or clothing or face soiled with grease, oil, creams and various ointments. Do not use greasy creams and lipsticks.
• Cylinders cannot be used if there is obvious damage or if they are suspected of being damaged or have been exposed to extreme temperatures.
• Only equipment suitable and compatible with the specific cylinder model can be used.
• Pliers or other tools must not be used to open or close the cylinder valve to prevent the risk of damage.
• In case of leakage, the cylinder valve must be closed immediately if it can be done safely. If the valve cannot be closed, the cylinder must be moved to a safer place outdoors to allow the air to escape freely.
• The valves of empty cylinders must be kept closed.
• The gas must not be administered under pressure. Pregnancy and breastfeeding.There are no contraindications for the use of medical air at atmospheric pressure during pregnancy or breastfeeding. Effects on the ability to drive and operate machines. The use of medical air does not alter the ability to drive or operate machines/equipment.

Dosage, method and duration of administration
Dosage, frequency and duration of treatment depend on the therapeutic indications and the
patient's clinical condition.
In particular, in cases of hypoxia, the flow and duration of application must be established in
relation to the cause of the hypoxia. In these cases, artificial ventilation via medical air
aims:

• To restore the normal tidal volume of about 500 ml of air in adults; in children this volume varies depending on weight, height, sex and age.
• To restore normal oximetry, whose normal values are between 94-100% corresponding to PaO values greater than or equal to 60. In highly premature infants, relatively lower oximetry values are considered acceptable in the first hours of life. When replacement of ambient air is necessary, the purpose of using medical air is to ensure a reliable supply of gas containing oxygen at a concentration corresponding to that in normal ambient air without the risk of administering potentially irritating substances. Medical air must be mixed with medical oxygen to obtain the desired oxygen concentration using the following formula:

FiO =
[(number of liters of air/minute x 21) + (number of liters of oxygen/minute x 100)]
[(number of liters of air/minute + number of liters of oxygen/minute) x 100)]
Method of administration
In artificial ventilation and stages of resuscitation of infarcts, pharmaceutical vehicle, in stages of hyperoxia/hypoxia and in anesthesia, medical air is generally administered
by inhalation via face mask or oro- and nasotracheal tubes, administered using various
techniques, generally from breathing and ventilation equipment and can be delivered with
pressure and volumetric type systems.
In cavity insufflation, medical air is conveyed via the endoscope which is generally
provided with a special cannula.

Instructions for use and handling
All persons handling medical air cylinders should have adequate knowledge of:

• Gas properties;
• Correct operating procedures for the cylinder;
• Precautions and actions to be taken in case of emergency. Medical air cylinders are reserved exclusively for containing/transporting air for inhalation, for therapeutic use. Cylinders must be transported using appropriate means to protect them from the risk of impact and falling. Imperatively respect the following instructions:
• Read the cylinder (package) instruction and use manual carefully
• Verify that all material is in good condition
• Secure the cylinders to keep them in a vertical position (especially the smaller cylinders) and avoid accidental falls, protect them from impacts and keep them at a temperature below 50°C, ensuring adequate ventilation/aeration of the premises where the product is used. Cylinders must be equipped with a cap/tulip to protect the valve.
• Handle the material with clean hands, free of traces of grease or oil.
• Lift and move the cylinders using only the appropriate trolley, do not lift the cylinder by the valve.
• Use fittings, connecting tubes or flexible connectors specifically designed and compatible.
• Particular attention must be paid to the fixing of pressure regulators on the cylinders, in order to avoid the risk of accidental breakage.
• It is strictly forbidden to intervene in any way on the cylinder connections, on the delivery equipment and its accessories or components ( OIL AND GREASE CANSPONTANEOUSLY IGNITE ON CONTACT WITH OXYGEN)
• Do not grease or attempt to repair defective valves/taps.
• It is strictly forbidden to handle equipment or components with hands or clothing or face soiled with grease, oil, creams and various ointments.
• Cylinders cannot be used if there is obvious damage or if they are suspected of being damaged or have been exposed to extreme temperatures.
• Only equipment suitable and compatible with the specific cylinder model can be used.
• Pliers or other tools must not be used to open or close the cylinder valve to prevent the risk of damage.
• In case of leakage, the cylinder valve must be closed immediately if it can be done safely. If the valve cannot be closed, the cylinder must be moved to a safer place outdoors to allow the air to escape freely.
• The valves of empty cylinders must be kept closed.
• The gas must not be administered under pressure. Pregnancy and breastfeeding.There are no contraindications for the use of medical air at atmospheric pressure during pregnancy or breastfeeding. Effects on the ability to drive and operate machines. The use of medical air does not alter the ability to drive or operate machines/equipment.

General instructions for use

• 1. Remove the seal and the protective cap of the outlet valve.
• 2. Make sure the cap is put aside so that it can be reinserted after use.
• 3. Do not remove or discard labels attached to the cylinder/cylinder pack.
• 4. Make sure that the cylinder/cylinder pack is associated with a pressure regulator specific for medical air and that the connection is compatible with that of the cylinder/cylinder pack valve.
• 5. Make sure the fitting on the regulator is clean.
• 6. Connect the pressure regulator, using only a modest pressure and connect the tubing to the outlet of the regulator/flow meter.
• 7. Open the cylinder valve slowly and gradually (without forcing) and check for leaks. If there are leaks, they will be made evident by a hiss; if the leak occurs between the outlet of the valve and the pressure regulator, remove the connections and clean them; reconnect the pressure regulators to the valve with moderate energy. Never use adhesive compounds or the like to plug a leak. If the leak persists, label the cylinder and return it to the manufacturer.

NOTE: FOR MORE DETAILS CONSULT THE CYLINDER USAGE MANUAL
ATTENTION

• Make sure that there is sufficient air remaining in the cylinder to guarantee the complete prescribed administration.
• Check that the regulator connection is clean and in good condition before connecting it to the valve.
• Check that the pressure regulator is correctly attached before opening the valve.
• Open the valve gradually to avoid pressure surges.
• Do not force taps and valves during opening and closing.
• Do not attempt to open or repair defective valves or reducers.
• Never position yourself in front of the gas outlet from the tap/valve, but always on the opposite side. Do not expose yourself or the patient to the direct flow of gas.
• Do not use oil or grease in contact with the gas.
• Do not completely empty the container.
• After use, close the cylinder valve.
• In case of gas leakage, close the valve and notify the technical intervention service of the supplier indicated on the Cylinder Usage Manual.
• Use only cylinders suitable for medical air, at the foreseen pressures and temperatures of use, pressure regulators designed for medical air and devices designed for the administration of medical air.

During use
When medical air cylinders are in use, make sure that:

• they are used only as medical gases (do not use for purposes other than those established by the doctor).
• they are handled with care without violent movements in order to avoid falls
• they are well fixed in a vertical position on a support
• it is not allowed that markings, labels or adhesives connected are altered or removed
• they are not used near people who are smoking or near heat sources. Also:
• do not use greasy creams and lipsticks.
• Do not smoke.
• Do not approach the package with open flames.
• No electrical equipment that can emit sparks should be used near patients receiving oxygen.
• Do not use oils or greases on connections, taps, valve and on any material in contact with oxygen.
• Never introduce air into an apparatus that could contain combustible materials and in particular fatty substances.

After use
When the medical air cylinder is empty, make sure that:

• the valves are closed manually without forcing, using only moderate force to close the valve
• the pressure regulator and/or the connection is depressurized
• the cap is put back on the valves, placing it in its seat
• empty cylinders with the valves closed and the protective cap are placed in a special storage area before being returned to the manufacturer.

Disposal
It is recommended not to dispose of medical air cylinders as waste. Do not discharge into sewers, basements or excavations where accumulation may be dangerous.
Cylinders must be returned to the supplier with a slight presence of residual gas (the
presence of residual pressure prevents contamination of the cylinder).
Any unused medicinal product residue present in the cylinder under pressure will be
eliminated, through appropriate procedures, by the company that will proceed to refill the
same cylinder.
If, for safety reasons, a cylinder must be emptied after use, the gas should be
released into a well-ventilated atmosphere.
Contact the supplier if further information on emptying the cylinders is needed.

Unused medicine and waste materials from this medicine must be disposed of in
accordance with local regulations.
Firefighting measures
In case of potential involvement in a fire:

• remove the cylinders from the area that could be affected by the fire.
• Close the cylinder valves to prevent gas flow.
• Move the cylinders away from the heat source. In case of involvement in a fire:
• remove the cylinders and cool them with water from a safe position.
• All types of fire extinguishers can be used when dealing with a fire involving medical gas cylinders. No toxic combustion products are released from the medical gas.

Measures in case of accidental opening
If a large volume of air is released into the environment, there are no particular problems:
Close the cylinder valve.
Cylinder transport:
Cylinders must be transported using appropriate material to protect them from the risk of
impact and falling (e.g. a trolley equipped with chains, barriers or rings).
Particular attention must be paid to ensure that there are no leaks and that the cylinders
have tightly closed valves; also check the fixing of the pressure regulator to avoid the
risk of accidental breakage.
During transport in vehicles, the cylinders must be securely fastened, preferably in
an upright position, in an area separate from the driver's cabin. Permanent ventilation of the vehicle and a no-smoking policy must be ensured.
Ensure that the driver is aware of the hazards of the load and knows what to do in the event
of accidents or emergencies. It is advisable to provide the driver with written instructions explaining in
detail the actions to be taken in the event of an accident or emergency.

Overdose
Not applicable, although the administration of medical air under pressure can cause
decompression sickness (due to the effects of nitrogen) and oxygen can be toxic.

Undesirable effects

Like all medicines, oxygen can cause side effects, although not everyone will experience them.

Very common side effects: dry mouth, headache.

Expiry date and storage
Expiry date:see the expiry date indicated on the packaging.
The expiry date indicated refers to the product in intact packaging, correctly
stored.

Warning:do not use the medicine after the expiry date indicated on the packaging.

Storage
Observe all relevant rules for the use and handling of pressure cylinders.
Store the cylinders at temperatures between –10°C and 50°C, in well-ventilated areas,
illuminated with a cold light source and equipped with appropriate emergency systems, in an
upright position with the valves closed, protected from rain, weather, exposure to direct sunlight
and away from sources of heat or ignition (including electrostatic charges) and flammable material.
Empty or containers containing other types of gas must be stored separately.
Cylinders must be used on a strict rotation basis so that cylinders with an earlier
filling date are used first

Unused medicine and waste materials from this medicine must be disposed of in
accordance with local regulations (see also Instructions for Use – Disposal).
Keep the medicine out of the reach and sight of children
Composition
The cylinders contain compressed atmospheric air

Pharmaceutical form and content
Compressed medicinal gas

ARIA MEDICAIR compressed medical gas is packaged in cylinders and cylinder packs, in

the state of compressed gas at 200 bar at 15°C. The cylinders are made of steel, equipped with shut-off and delivery valves capable of connecting to a pressure regulator so that the
medicinal product can be used.
The cylinders containing air intended for medicinal use have a conventional external colour identification
characterised by having a white body and a white-sky blue ogive.

Marketing Authorisation Holder
MEDICAIR ITALIA S.R.L. – VIA T. TASSO 29 - POGLIANO MILANESE

Manufacturer
Medicair Italia srl- Via T. Tasso 29 – 20010 Pogliano Milanese (MI)

25-10-2012