Composition of Medical Oxygen Gas Oxigen Salud

- The active ingredient is Oxygen 99.5% v/v

Aspect of the product and contents of the packaging

Oxigen Medicinal Gas Oxigen Salud, is a gas for inhalation that is packaged in cylinders at 200 bars of pressure at 15°C. The cylinders can be made of steel, compact steel, aluminum or compact aluminum of the following volumes

Cylinders of 0.75 L that provide 0.15 m3at 15°C and at a pressure of 1 bar.

Cylinders of 1 L; that provide 0.2 m3at 15°C and at a pressure of 1 bar.

Cylinders 1.4 L; that provide 0.28 m3at 15°C and at a pressure of 1 bar.

Cylinders 1.6 L; that provide 0.32 m3at 15°C and at a pressure of 1 bar.

Cylinders 2 L; that provide 0.4 m3at 15°C and at a pressure of 1 bar.

Cylinders 2.5 L; that provide 0.5 m3at 15°C and at a pressure of 1 bar.

Cylinders 2.75 L; that provide 0.55 m3at 15°C and at a pressure of 1 bar.

Cylinders 3 L; that provide 0.6 m3at 15°C and at a pressure of 1 bar.

Cylinders 3.5 L; that provide 0.7 m3at 15°C and at a pressure of 1 bar.

Cylinders 4 L; that provide 0.8 m3at 15°C and at a pressure of 1 bar.

Cylinders 4.55 L; that provide 0.91 m3at 15°C and at a pressure of 1 bar.

Cylinders 4.7 L; that provide 0.94 m3at 15°C and at a pressure of 1 bar.

Cylinders 5 L; that provide 1 m3at 15°C and at a pressure of 1 bar.

Cylinders 6.7 L; that provide 1.34 m3at 15°C and at a pressure of 1 bar.

Cylinders 7 L; that provide 1.4 m3at 15°C and at a pressure of 1 bar.

Cylinders 10 L; that provide 2 m3at 15°C and at a pressure of 1 bar.

Cylinders 10.7 L; that provide 2.14 m3at 15°C and at a pressure of 1 bar.

Cylinders 13 L; that provide 2.6 m3at 15°C and at a pressure of 1 bar.

Cylinders 13.4 L; that provide 2.68 m3at 15°C and at a pressure of 1 bar.

Cylinders 15 L; that provide 3 m3at 15°C and at a pressure of 1 bar.

Cylinders 20 L; that provide 4 m3at 15°C and at a pressure of 1 bar.

Cylinders 28 L; that provide 5.54 m3at 15°C and at a pressure of 1 bar.

Cylinders 30 L; that provide 6 m3at 15°C and at a pressure of 1 bar.

Cylinders 40 L; that provide 8 m3at 15°C and at a pressure of 1 bar.

Cylinders 50 L; that provide 10 m3at 15°C and at a pressure of 1 bar.

Blocks 12x50 600 L; that provide 120 m3at 15°C and at a pressure of 1 bar.

Blocks 16x50 800 L; that provide 160 m3at 15°C and at a pressure of 1 bar.

It may not be commercially available all sizes of packaging.

Holder of the marketing authorization and responsible for manufacturing

OXIGEN SALUD, S.A.

Carretera Rubí 141-143

08174 Sant Cugat del Vallès (Barcelona)

Responsible for manufacturing

OXIGEN SALUD, S.A.

Carretera Rubí 141-143

08174 San Cugat del Valles (Barcelona)

Ó

OXIGEN SALUD, S.A.

Polígono Industrial, Calle A, Parcela 63.

09320 Madrigal del Monte (Burgos)

Revision date of the prospectus:

November 2022.

The detailed and updated information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

This information is intended solely for healthcare professionals

Instructions for use/manipulation

Do not smoke.

Do not approach a flame.

Do not grease.

Especially:

• Do not introduce this gas into an apparatus that is suspected to contain combustible materials, especially if they are greasy;

• Do not clean with combustible products, especially if they are greasy, the apparatus that contains this gas or the valves, the joints, the seals, the devices for closing and the valves;

• Do not apply any greasy substance (vaseline, ointments...) to the face of the patients;

• Do not use aerosols (lacquer, deodorant...) or solvents (alcohol, perfume...) on the material or near it.

The oxygen medical cylinders are reserved exclusively for therapeutic use.

To avoid any incident, it is necessary to respect the following instructions:

1. Verify the good condition of the material before its use.
2. Group the cylinders with a capacity greater than 5 L with a suitable means (chains, hooks...) to keep them in a vertical position and avoid any accidental fall; do not use the cylinders if their pressure is less than 10 bars.

1. Do not force the cylinder into a support that is too narrow for it.

1. Manipulate the material with clean and grease-free hands.

1. Manipulate the 50 L or more cylinders with clean and protective gloves and safety shoes.

1. Verify in advance that the cylinder is provided with an intact inviolability guarantee system.

1. Do not manipulate a cylinder whose valve is not protected by a tulip, except for cylinders with a capacity less than 5 L.

1. Do not lift the cylinder by the valve.

1. Use specific connections or flexible connection elements for oxygen.

1. Use a reducer with a flowmeter that can admit a pressure of at least 1.5 times the maximum service pressure (200 bars) of the cylinder (except if there is already a built-in reducer on the valve).

1. Use graduated manometers with a minimum of 315 bars for the cylinder holders.

1. Use flexible connection elements in the wall outlets, provided with specific nozzles for oxygen.

1. Open the valve or valve gradually.

1. Do not force the valve to open it, nor open it completely.

1. Purge the outlet connection of the cylinder before incorporating the reducer to eliminate any dust that may have accumulated. Keep the connections between the cylinder and the reducer clean.

1. Do not subject the reducer to several successive pressurizations.

1. Do not position yourself in front of the outlet of the valve, but always on the opposite side of the reducer, behind the cylinder and backwards. Do not expose patients to the gas flow.

1. Do not use intermediate connections to allow the connection of two devices that do not fit together.

1. Do not attempt to repair a defective valve.

1. Do not tighten the reducer-caudalímetro with pliers, under risk of causing defects in the joint.

1. Verify in advance the compatibility of the materials in contact with oxygen, using in particular special seals for oxygen on the reducer.

1. Close the valve of the cylinder after its use, allow the pressure of the reducer to decrease, leaving the flowmeter open, close the flowmeter and loosen the adjustment screw of the reducer (except in the case of integrated reducers).

1. In case of leakage, close the valve or valve of the circuit that has a leak, do not use a cylinder that presents a leak, and check that the emergency device is activated.

1. Do not empty a cylinder completely.

1. Keep the empty cylinders with the valve closed and the empty holders with the valve closed (to avoid corrosion processes in the presence of humidity).

1. Do not transfer gas under pressure from one cylinder to another.

1. Ventilate if possible the place of use, if it is a small location (vehicles, home).