Oxygen Vivisol

Italy
Brand name Oxygen Vivisol
Form gas, cryogenic medicinal
Active substance / Dosage
Prescription type Prescription only
ATC code
Registration number 039058
Manufacturer VIVISOL S.R.L.

Package leaflet: Information for the patient

OXYGEN VIVISOL 200 BAR COMPRESSED MEDICINAL GAS, CRYOGENIC MEDICINAL GAS

Oxygen
Please read this leaflet carefully before using this medicine as it contains
important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any questions, consult your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
  • If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

  1. What medicinal oxygen is and what it is used for
  2. What you need to know before using medicinal oxygen
  3. How to use medicinal oxygen
  4. Possible side effects
  5. How to store medicinal oxygen
  6. Contents of the pack and other information

The full name of this medicine is Oxygene Vivisol 200 bar compressed medicinal gas and Oxygene Vivisol cryogenic medicinal gas. For convenience, it will be referred to as "medicinal oxygen" throughout this leaflet.

1. What is medicinal oxygen and what is it used for

Medicinal oxygen contains oxygen, a gas naturally present in the air we breathe.
Medicinal oxygen increases the delivery of oxygen to all tissues of the body.
Medicinal oxygen is indicated in patients of all ages for the treatment of respiratory disorders (acute and chronic respiratory failure).

2. What you need to know before using medicinal oxygen

Under normal conditions, there are no contraindications.
Warnings and precautions

Before starting oxygen therapy, you should be aware of the following:

  • Oxygen may have harmful effects at high concentrations. It can cause lung damage (alveolar collapse, lung inflammation) that hinders blood oxygenation.
  • If you suffer from severe chronic obstructive pulmonary disease (COPD) resulting in poor blood oxygenation, the oxygen flow rate will be low. Your doctor will determine the most appropriate flow rate for oxygen therapy.
  • Exercise particular caution when administering oxygen to full-term and preterm neonates to minimize the risk of adverse events such as eye damage. The lowest possible oxygen concentration that ensures adequate oxygenation should be used.
  • Exercise particular caution if you have elevated blood levels of carbon dioxide, which may counteract the effects of oxygen.
  • If you have respiratory problems caused by low oxygen levels in the blood or if you are taking strong painkillers, you must be closely monitored by your doctor.
  • If you have previously had a lung injury, inform your doctor.

Consult your doctor or pharmacist before using medicinal oxygen.
Advice regarding fire risk in the presence of oxygen:

  • Oxygen is an oxidizing agent and promotes combustion. In areas where medicinal oxygen is used, there must be no sources of heat, smoking, or open flames (e.g. pilot lights, stoves, ovens, gas heaters, sparks, candles), as this increases the risk of fire.
  • Do not smoke in any environment where oxygen therapy is administered.
  • Do not use electrical devices during your oxygen treatment.
  • In oxygen-enriched environments, oxygen may saturate clothing.
  • Do not apply greasy substances (e.g. oils, creams, lotions) to surfaces in contact with oxygen. Only water-based products should be used on the hands, face, or inside the nose.
  • Do not use pliers or other tools to open or close the cylinder valve to prevent the risk of damage.
  • The pressure regulator must be opened slowly and carefully to avoid the risk of sudden ignition.
  • In case of leakage, immediately close the cylinder valve if this can be done safely. If the valve cannot be closed, the cylinder must be moved to a safer outdoor location to allow oxygen to escape freely.
  • Always keep valves of empty cylinders closed.

Thermal burns related to accidental fire have occurred in the presence of oxygen.
Advice for caregivers:

  • Handle the cylinder with care. Ensure that the gas cylinder is not dropped or subjected to impacts.
  • Damage to equipment may cause blockage of the outlet and/or incorrect readings on the pressure gauge regarding residual oxygen content and flow, leading to insufficient or absent oxygen delivery.
    • Oxygen becomes liquid at approximately -183°C. At such low temperatures, there is a risk of frostbite. Always wear protective gloves and eye protection when handling liquid medicinal oxygen. If liquid oxygen comes into contact with the skin or eyes, the affected areas must be rinsed thoroughly with cold water or cold compresses applied; if such injuries occur, immediate medical assistance must be sought.

Children
In preterm and full-term neonates, oxygen therapy may cause eye damage (retinopathy of prematurity) and/or lung damage and brain hemorrhages. The doctor will determine the appropriate oxygen concentration to administer to the neonate for optimal treatment.
Other medicines and medicinal oxygen
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

In particular, inform your doctor or pharmacist if you are taking or have been prescribed:

  • bleomycin
  • catecholamines (e.g. epinephrine, norepinephrine), medicines that affect multiple body organs and are generally used in the emergency treatment of sudden allergic reactions,
  • corticosteroids (e.g. dexamethasone, methylprednisolone), medicines used to treat inflammation,
  • hormones (e.g. testosterone, thyroxine),
  • amiodarone, a medicine used to treat heart rhythm disorders,
  • chemotherapeutic agents (e.g. bleomycin, cyclophosphamide, 1,3-bis(2-chloroethyl)-1-nitrosourea) and adriamycin, medicines used to treat tumors,
  • antimicrobial agents (e.g. nitrofurantoin), medicines used to treat microbial infections,
  • antibiotics (e.g. bleomycin, actinomycin), medicines used to treat infections,
  • vitamin K supplements (menadione),
  • medicines used to treat mental disorders (e.g. promazine, chlorpromazine, thioridazine),
  • chloroquine, a medicine used to treat malaria.

Additionally, inform your doctor if:

  • you have recently undergone an X-ray,
  • you have undergone treatment for paraquat poisoning (a herbicide). Pre-existing lung damage caused by the pesticide paraquat may be worsened by oxygen. In cases of paraquat poisoning, administration of supplemental oxygen should be avoided as much as possible.
  • you suffer from hyperthyroidism or deficiency in vitamin C, vitamin E, or glutathione (an antioxidant substance), as these may increase oxygen toxicity.

Medicinal oxygen and alcohol
Do not consume alcohol during oxygen therapy. Alcohol may impair breathing.
Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor, pharmacist, or nurse before taking this medicine.

  • During pregnancy, oxygen at normal pressure (normobaric oxygen therapy) should be administered only if necessary.
  • There are no contraindications for the use of oxygen during breastfeeding.

Driving and using machines
The use of medicinal oxygen at normal pressure (normobaric oxygen therapy) does not impair or impairs negligibly the ability to drive or operate machinery. Consult your doctor before driving or operating machinery.

3. How to use medicinal oxygen

Use this medicine exactly as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor.
If you do not have respiratory insufficiency, medicinal oxygen will be inhaled through the nose and mouth using a nasal cannula or a face mask.
If you suffer from respiratory insufficiency or are undergoing anesthesia, medicinal oxygen will be administered via assisted ventilation.
The dose will be determined by your doctor based on your health condition.
During treatment with medicinal oxygen, your doctor may perform measurements of arterial blood gases and monitor hemoglobin oxygen saturation levels, where hemoglobin is a protein that carries oxygen in the blood.

If you use more medicinal oxygen than you should
If you use more medicinal oxygen than prescribed, contact your doctor immediately or go to the hospital immediately.
The toxic effects of oxygen vary depending on the pressure of inhaled oxygen and the duration of exposure.
Effects on the lungs (pulmonary region) include shortness of breath, cough, chest pain, interstitial edema, and pulmonary fibrosis.
Effects on the brain and spinal cord (central nervous system) include ringing in the ears, visual and hearing disturbances, nausea, dizziness, anxiety, confusion, irritability, localized muscle cramps (around the eyes, mouth, and forehead), loss of consciousness, and seizures (epileptic fits).
Ocular effects include blurred vision and reduced peripheral vision ("tunnel vision").
In premature infants, eye problems (retinopathy) may occur.
In case of oxygen poisoning due to hyperoxia, oxygen therapy should be reduced or, if possible, discontinued, and symptomatic treatment should be initiated.

If you forget to use medicinal oxygen
Use oxygen as described in the Dosage section of this leaflet. Do not use a double dose to make up for a forgotten dose, as medicinal oxygen may be harmful at high concentrations.

If you stop using medicinal oxygen
Do not stop using this medicine on your own initiative. Consult your doctor or pharmacist.

Safety advice on the use of medicinal oxygen
Oxygen is an oxidizing agent and promotes combustion. Smoking or open flames (e.g. pilot flames, stoves, ovens, gas heaters, sparks, candles, etc.) must not be present in rooms where medicinal oxygen is used, as they increase the risk of fire.
Handle the cylinder with care. Ensure that the gas cylinder does not fall or suffer impacts.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Below are the side effects associated with Ossigeno VIVISOL.

Very common (may affect more than 1 in 10 people)
In newborns exposed to high oxygen concentrations: eye damage, which may lead to visual impairment.

Uncommon (may affect up to 1 in 100 people)
Pulmonary collapse (atelectasis).

Not known (frequency cannot be estimated from the available data)
Pulmonary toxicity, worsening of excess carbon dioxide in the blood (hypercapnia), dryness of mucous membranes, local irritation and inflammation of mucous membranes.

Limited to the cryogenic formulation
Cold burns may occur from direct contact with liquid oxygen (see section
"Warnings and precautions").

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor, pharmacist or nurse. You may also report side effects directly via the national reporting system at the following website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store medicinal oxygen

Store cylinders and mobile cryogenic containers at temperatures between -10°C and 50°C.
Keep this medicinal product out of the sight and reach of children.
Do not use this medicinal product after the expiry date stated on the label after EXP.
The expiry date refers to the last day of that month.
Do not dispose of any medicinal product down the drain or in household waste. Ask your pharmacist
how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What medicinal oxygen contains
The active substance is oxygen.
Description of the appearance of medicinal oxygen and package contents
Compressed medicinal gas
OSSIGENO VIVISOL compressed medicinal gas is supplied in cylinders in compressed gaseous form at 200 bar and 15°C. The cylinders are made of steel and equipped with valves suitable for connection to a pressure reducer or with integrated pressure-reducing valves.
Cryogenic medicinal gas
OSSIGENO VIVISOL cryogenic medicinal gas is supplied in mobile cryogenic containers (base units).
Available pack sizes:
Compressed medicinal gas
Steel cylinders with valves of 5, 7, 10, 14, 27, and 30 litres.
Cryogenic medicinal gas
Mobile cryogenic containers of 10, 20, 29, 31, 38, 41, and 46 litres.
Not all pack sizes may be marketed.
Marketing Authorization Holder
VIVISOL S.r.l.
Via Borgazzi, 27
Monza (MI)
Manufacturer
Compressed medicinal gas
SOL SpA – 4 Strada z.i. Macchiareddu – Assemini (CA)
SOL SpA – Via Enzo Ferrari – Catania
SOL SpA – Via Acquaviva, 4 – Cremona
SOL SpA – Via Giovanni Francesco Maggiò snc – Marcianise (CE)
VIVISOL Srl – Via Manin, 153 – Sesto San Giovanni (MI)
Cryogenic medicinal gas
I.C.O.A. Srl Industria Calabrese Ossigeno ed Acetilene – Zona Industriale (Loc. Porto Salvo), Vibo Valentia
SOL SpA – 4 Strada z.i. Macchiareddu – Assemini (CA)
SOL SpA – Via Enzo Ferrari – Catania
SOL SpA – Via Acquaviva, 4 – Cremona
SOL SpA – Via dei Ciclamini, 19 – Modugno (BA)
SOL SpA – Via Belgio, 16 – Padova
SOL SpA – Via Nugolaio, 4 – Pisa
SOL SpA – Via dei Mandarini, 6 – Pomezia (RM)
SOL SpA – Via Poli, 2/A – Zola Predosa (BO)
SOL SPA – Via de Francisco, 148/8-9 – Settimo Torinese (TO)
VIVISOL NAPOLI Srl – Via Giovanni Francesco Maggiò snc – Marcianise (CE)
VIVISOL Srl – Via de Spuches, 39 – Carini (PA)
VIVISOL Srl – Via Aquileia – Romans d'Isonzo (GO)
VIVISOL Srl – Via Novello Z.I.P.A. – Jesi (AN)
VIVISOL Srl – Via Manin, 153 – Sesto San Giovanni (MI)
CER MEDICAL Srl – Via Torretta, 13 – Calderara di Reno (BO)
MEDICAIR CENTRO Srl – Loc. Prato Sardo, Lotto n.58 – Nuoro (NU)
MEDICAIR SUD Srl – Zona Asi Traversa n.20 di Via di Blasio n.5 – Bari (BA)
MEDICAIR SUD Srl – Contrada S. Benedetto Zona ASI – Favara (AG)
MEDICAIR SUD Srl – Via Bruxelles, 100 – Soleto (LE)
MEDICAIR SUD Srl – Contrada Canne Masche, SNC – Termini Imerese (PA)



The following information is intended exclusively for physicians or healthcare professionals:
Precautions for use
Oxygen must be administered with caution, adjusted according to the individual patient's needs. The lowest effective dose that maintains arterial oxygen pressure at 8 kPa (60 mmHg) should be administered. Higher concentrations should be given for the shortest possible duration, with frequent monitoring of blood gas analysis.
Oxygen can be safely administered at the following concentrations and for the following durations:
Up to 100% for less than 6 hours
60–70% for 24 hours
40–50% during the second 24-hour period.
Oxygen may become toxic after two days when administered at concentrations exceeding 40%.
Low oxygen concentrations should be used in patients with respiratory failure in whom the respiratory drive is stimulated by hypoxia. In these cases, treatment must be closely monitored by measuring arterial oxygen tension (PaO₂), or by pulse oximetry (arterial oxygen saturation – SpO₂), along with clinical assessment.
Administering oxygen to patients with drug-induced respiratory failure (opioids, barbiturates) or chronic obstructive pulmonary disease (COPD) may further worsen respiratory failure due to hypercapnia caused by elevated blood carbon dioxide levels, which neutralizes the effects on receptors.
High oxygen concentrations in inhaled air or gas reduce nitrogen concentration and partial pressure. This also reduces nitrogen levels in tissues and alveoli. If oxygen is absorbed into the blood through the alveoli faster than it is replenished by ventilation, alveolar collapse (atelectasis) may occur. This can impair arterial blood oxygenation, as gas exchange does not occur despite adequate perfusion.
In patients with reduced sensitivity to arterial carbon dioxide pressure, high oxygen levels may cause carbon dioxide retention. In extreme cases, this may lead to carbon dioxide narcosis.
High oxygen concentrations should be administered for the shortest time necessary to achieve the desired effect, with repeated monitoring of arterial blood gas pressure (PaO₂) or peripheral hemoglobin oxygen saturation (SpO₂), along with clinical evaluation.
Patients at risk of hypercapnic respiratory failure
Special precautions must be taken in patients with reduced sensitivity to arterial carbon dioxide pressure or at risk of hypercapnic respiratory failure ("hypoxic drive") (e.g., patients with chronic obstructive pulmonary disease (COPD), cystic fibrosis, morbid obesity, chest wall deformities, neuromuscular disorders, or respiratory depressant drug overdose), and in patients with drug-induced respiratory failure (opioids, barbiturates), as oxygen administration may worsen respiratory failure due to hypercapnia caused by elevated blood carbon dioxide levels, which counteracts oxygen's effects on receptors.
Supplemental oxygen administration may cause respiratory depression and increased PaCO₂, leading to symptomatic respiratory acidosis. In these patients, oxygen therapy must be carefully titrated; the target oxygen saturation may be lower than in other patients, and oxygen should be administered at low flow rates.
Special precautions in patients with bleomycin-induced lung injury
Pulmonary toxicity from high-dose oxygen therapy may exacerbate lung damage, even years after the initial lung injury caused by bleomycin. The target oxygen saturation in these patients may need to be lower than in others.
Paediatric population
Due to the newborn's increased sensitivity to supplemental oxygen, the lowest effective concentration should be used to achieve adequate oxygenation.
In preterm and term neonates, increased PaO₂ may lead to retinopathy of prematurity, chronic lung disease, and intraventricular haemorrhage.
It is recommended to initiate resuscitation of term or near-term newborns with air rather than 100% oxygen. In preterm neonates, the optimal oxygen concentration and target oxygen saturation are not precisely defined. If supplemental oxygen is required, it should be carefully monitored and guided by pulse oximetry.
Fire hazard:

  • Any oxygen delivery system or container must be kept away from sources of heat due to oxygen's combustive properties. Appropriate precautions must be taken both in hospital and home settings when handling medicinal oxygen.
  • Oxygen may cause spontaneous ignition of smouldering materials or embers; therefore, smoking or open, unshielded flames are strictly prohibited near oxygen containers and delivery systems.
  • Do not smoke in areas where oxygen therapy is administered.
  • Do not place cylinders or containers near sources of heat.
  • Electrical equipment capable of producing sparks must not be used near patients receiving oxygen.
  • It is absolutely forbidden to tamper in any way with container connections, delivery equipment, or their accessories or components (OIL AND GREASE MAY SPONTANEOUSLY IGNITE ON CONTACT WITH OXYGEN).
  • Contact with oil, grease, or other hydrocarbons must be avoided.
  • It is absolutely forbidden to handle equipment or components with hands, clothing, or face contaminated with grease, oil, creams, or ointments. Do not use greasy creams or lipsticks.
  • In oxygen-enriched environments, oxygen may saturate clothing.
  • Cylinders must not be used if visibly damaged or if damage or exposure to extreme temperatures is suspected.
  • Only oxygen-compatible and appropriate equipment must be used for the specific container model.
  • Pliers or other tools must not be used to open or close the cylinder valve to prevent damage.
  • In case of leakage, the cylinder valve must be closed immediately, if safely possible. If the valve cannot be closed, the cylinder must be moved to a safe outdoor location to allow oxygen to escape freely.
  • Valves of empty cylinders must remain closed.
  • Oxygen has a strong oxidizing effect and may react violently with organic substances. Therefore, special precautions are required for handling and storage of containers.
  • Pressurized gas must not be administered directly.

Oxygen is an oxidizing product and promotes combustion. When using oxygen, the increased risk of fire ignition must be considered:

  • Fire hazard in domestic settings: Patients and caregivers must be informed of the fire risk associated with other ignition sources (smoking, flames, sparks, stoves, ovens, etc.) and/or highly flammable substances, particularly greasy materials (oils, grease, creams, ointments, lubricants, etc.). During oxygen use, only water-based products should be applied to the hands, face, and inside the nose.
  • Fire hazard in hospital settings: This risk is increased during procedures involving diathermy, defibrillation, and electrical cardioversion.
  • Fires may occur upon valve opening (due to friction heating).

Thermal burns associated with accidental fires in the presence of oxygen have occurred.
Cylinder handling:
Patients' caregivers and all individuals handling medicinal oxygen cylinders must be warned to handle cylinders carefully to avoid damage, particularly to the valve. Damage to the device may cause blockage of the outlet and/or incorrect readings on the pressure gauge regarding residual oxygen volume and flow rate, resulting in insufficient or interrupted oxygen delivery.
For the cryogenic formulation
Cold burns from direct contact with liquid oxygen:
Oxygen becomes liquid at approximately -183°C. At such low temperatures, direct contact of liquid oxygen with skin or mucous membranes may cause cold burns. Special safety precautions must be taken when handling cryogenic containers: appropriate protective clothing (gloves, goggles, loose clothing, and trousers covering shoes) must be worn. If liquid oxygen contacts skin or eyes, the affected areas must be rinsed thoroughly with abundant cold water or cold compresses applied; immediate medical assistance must be sought.
Dosage, method, and duration of administration
Oxygen (compressed or cryogenic) is administered via inhaled air, preferably using dedicated devices (e.g., nasal cannula or face mask); dosing is achieved independently of the medicinal gas packaging using dosing devices (flowmeters).
With these systems, oxygen is delivered through the inhaled air, while exhaled gas and any excess oxygen exit the patient's inspiratory circuit and mix with the surrounding air (open or anti-rebreathing system).
Normobaric oxygen therapy
Normobaric oxygen therapy refers to the administration of a gas mixture richer in oxygen than atmospheric air, i.e., with an inspired oxygen fraction (FiO₂) exceeding 21%, at a partial pressure between 0.21 and 1 atmosphere (0.213 and 1.013 bar).
In patients without respiratory failure, oxygen may be administered via spontaneous ventilation using nasal cannulas, nasopharyngeal catheters, or suitable masks.
In patients with respiratory failure or under anaesthesia, oxygen must be administered via assisted ventilation.
Oxygen cylinders contain gas under a pressure of approximately 200 bar. Pressure is regulated by a reducer and displayed on the pressure gauge. Multiplying the gauge reading by the cylinder volume in litres gives the amount of oxygen remaining in the cylinder.
(Example: Content calculation: a cylinder has a volume of 10 litres and the gauge reads 200 bar, resulting in 2000 litres of oxygen. With a consumption rate of 2 litres per minute, the cylinder will be empty after approximately 16 hours).
With spontaneous ventilation
Patients with chronic respiratory failure: administer oxygen at a flow rate of 0.5 to 2 litres/minute, adjustable according to blood gas analysis.
Patients with acute respiratory failure: administer oxygen at a flow rate of 0.5 to 15 litres/minute, adjustable according to blood gas analysis.
Paediatric population
Neonates may receive 100% oxygen when necessary. However, careful monitoring during treatment is required. It is recommended to avoid oxygen concentrations exceeding 40% to reduce the risk of lens damage or lung collapse. Arterial oxygen pressure (PaO₂) should be monitored; however, if maintained below 13.3 kPa (100 mmHg) and significant fluctuations in oxygenation are avoided, the risk of ocular damage is reduced. Additionally, the risk of ocular damage may be reduced by avoiding significant fluctuations in oxygenation (see also Precautions for use).
Instructions for use and handling
Medicinal oxygen cylinders and cryogenic containers are intended exclusively for containing/transporting oxygen for inhalation, for therapeutic use.
Cylinders and mobile cryogenic containers (Base Units) must be transported using appropriate means to protect them from impact and falling risks.
Strictly follow these instructions:

  • Carefully read the instruction and user manual of the container (package).
  • Check that all equipment is in good condition.
  • Secure cylinders and base units in an upright position to prevent falls. Protect containers from impacts and keep them at temperatures below 50°C, ensuring adequate ventilation/aeration of rooms where the product is used. Cylinders must be equipped with a protective cap/tulip over the valve.
  • Handle equipment with clean hands, free from traces of grease or oil.
  • Lift and move cylinders and base units only using the appropriate trolley; never lift the cylinder by the valve.
  • Use only oxygen-specific and compatible connectors, connection tubes, or flexible hoses.
  • Particular attention must be paid to securing pressure reducers to cylinders, if not already integrated into the container closure system, to prevent accidental breakage.
  • It is absolutely forbidden to tamper in any way with delivery equipment, accessories, or components (OIL AND GREASE MAY IGNITE ON CONTACT WITH OXYGEN).
  • Do not lubricate or attempt to repair defective valves/taps.
  • It is absolutely forbidden to handle equipment or components with hands, clothing, or face contaminated with grease, oil, creams, or ointments.
  • It is absolutely forbidden to touch frozen parts (for cryogenic containers).

General instructions for use
Cylinders equipped only with a shut-off valve

  1. Remove the protective cap if present
  2. Ensure the delivery valve is closed
  3. Remove the tamper-evident seal
  4. Connect the pressure reducer to the cylinder valve and the corresponding flowmeter
  5. Connect the humidifier/bubbler
  6. Connect the nasal cannula with mask or goggles to the humidifier
  7. Slowly open the main valve fully
  8. Adjust the flowmeter to the required flow rate (litres/minute)

Cylinders equipped with integrated pressure-reducing valve

  1. Ensure the valve is closed
  2. Remove the tamper-evident seal
  3. Ensure the flow indicator is set to zero
  4. Connect the humidifier/bubbler
  5. Connect the nasal cannula with mask or goggles to the humidifier
  6. Slowly open the main valve fully
  7. Adjust the flowmeter to the required flow rate (litres/minute)

Mobile cryogenic containers

  1. Ensure the flow indicator is set to zero
  2. Remove the tamper-evident seal
  3. Connect the humidifier/bubbler
  4. Connect the nasal cannula with mask or goggles to the humidifier
  5. Set the flow regulator to the required flow rate (litres/minute)

NOTE: FOR MORE DETAILS, CONSULT THE CONTAINER'S USER MANUAL
ATTENTION

  • Open container closure systems (valve or tap) gradually to avoid pressure surges.
  • Do not force taps or valves when opening or closing.
  • Never stand directly in front of the gas outlet of the tap/valve; always stand to the side. Do not expose yourself or the patient to direct gas flow.
  • Do not use oil or grease in contact with the gas.
  • Do not completely empty the container.
  • After use, close the cylinder tap.
  • In case of gas leakage, close the tap and contact the technical service of the supplier indicated in the container's user manual.
  • Use only containers suitable for the product and intended pressure and temperature conditions. During use
  • Do not use greasy creams or lipsticks.
  • Do not smoke.
  • Do not bring open flames near the container.
  • Do not use electrical equipment capable of emitting sparks near patients receiving oxygen.
  • Do not use oils or greases on connectors, taps, valves, or any material in contact with oxygen.
  • Never introduce oxygen into a device that may contain combustible materials, especially greasy substances.

Disposal

  • Store empty cylinders with valves closed.
  • Do not discharge into sewers, basements, or pits where accumulation may be hazardous.
  • Return empty or unused containers, even if partially full, to the supplier. Any residual unused medicinal product in the pressurized cylinder will be eliminated through appropriate procedures in a well-ventilated area by the company responsible for subsequent refilling of the same container.

Observe all relevant rules for the use and handling of pressurized cylinders and containers containing cryogenic liquids.
Store cylinders and mobile cryogenic containers at temperatures between -10°C and 50°C, in well-ventilated areas or well-ventilated sheds, avoiding the formation of oxygen-enriched atmospheres (O₂ > 21% vol), in an upright position with valves closed and protected from rain and weather, direct sunlight, and away from heat or ignition sources and combustible materials. Empty containers or those containing other types of gas must be stored separately.