KEOL-S GAS COMPRESSED MEDICINAL GAS BULLET

Introduction

Package Leaflet: Information for the Patient

KEOL-S

Compressed medical gas in gas cylinder

Medical oxygen 21.0 – 22.5% v/v

<Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor.
• This medicine has been prescribed for you, do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet.

Contents of the Package Leaflet

1. What is KEOL-S and what is it used for
2. Before using KEOL-S
3. How to use KEOL-S
4. Possible side effects
5. Storage of KEOL-S
6. Additional information

1. What is KEOL-S and what is it used for

KEOL-Sis Synthetic Medical Air, conditioned to 150 bar and 200 bar pressure in cylinders (bottles) and cylinder blocks. The cylinders can be made of steel, aluminum, or alloys.

KEOL-Sis used in assisted breathing:

• Mechanical ventilation:

In anesthesia, resuscitation (reanimation), ventilation: KEOL-Sis used as a feeding gas for respirators in assisted breathing.

• Neublization:

In aerosol therapy (treatment with aerosols), KEOL-Sis used as a vector gas (transport) in treatment.

2. Before Using KEOL-S

Do not use KEOL-S

? If the pressure is below 10 bar.

? When there is a flame nearby.

? When someone is smoking nearby.

Be especially careful with KEOL-S

? The cylinders must be installed in a location that allows them to be kept in a vertical position and protected from the risk of impacts and falls (such as a support with fixing chains).

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

? Never position yourself in front of the valve outlet, but always on the opposite side of the manoreducer, behind the cylinder, and backwards.

? At the time of delivery by the manufacturer, verify that the cylinder is equipped with an intact tamper-evident system (seal).

? Do not grease.

Use of other medicines

Tell your doctor if you are taking, have recently taken, or might take any other medicines, including those bought without a prescription.

Pregnancy and breastfeeding

Consult your doctor before using any medicine.

Driving and using machines

KEOL-Sdoes not affect your ability to drive or use machines.

3. How to Use KEOL-S

Follow exactly the administration instructions of KEOL-S indicated by your doctor. Consult your doctor if you have doubts.

Your doctor will determine the correct dose of KEOL-S and will administer it through a system suitable for your needs, ensuring the supply of the correct amount of medical air.

If you think the effect of KEOL-S is too strong or too weak, tell your doctor.

If you interrupt treatment with KEOL-S, your doctor will indicate the duration of your treatment with KEOL-S. Do not stop treatment before, as it may not be effective.

If you have any other doubts about the use of this product, ask your doctor.

Instructions for use:

• Use specific connection elements for Medical Air.
• Never tighten the manoreducer-flowmeter with pliers, under the risk of causing damage to the gasket.
• Never completely empty a cylinder or cylinder block, always leave a minimum pressure of 10 bar.
• Keep empty cylinders in a vertical position, with the valve closed.

4. Possible Side Effects

Like all medicines, KEOL-Scan cause side effects, although not everybody gets them.

No side effects are expected if the administration instructions are followed.

If you think any of the side effects you are experiencing is serious, or if you notice any side effects not mentioned in this leaflet, tell your doctor or pharmacist.

5. Storage of KEOL-S

Keep out of the reach and sight of children.

Do not use KEOL-S after the expiration date stated on the packaging after EXP. The expiration date is the last day of the month indicated.

All regulations regarding the handling of pressure vessels must be followed.

Regarding storage and transportation, the following must be taken into account:

Storage of cylinders:

• Cylinders must be stored in a well-ventilated or ventilated area, protected from the weather, clean, without flammable materials, reserved for the storage of medical gases, and can be locked.
• Empty and full cylinders must be stored separately.
• Cylinders must be protected from the risk of impacts or falls, as well as from heat sources or ignition, temperatures equal to or above 50°C, and combustible materials and weather conditions.

Storage of cylinders in the user service:

• The cylinder must be installed in a location that allows it to be protected from the risk of impacts and falls (such as a support with fixing chains), heat sources or ignition, temperatures equal to or above 50°C, combustible materials, and weather conditions.
• Excessive storage of packaging should be avoided.

Transportation of cylinders:

• Cylinders must be transported with the help of suitable material (such as a cart equipped with chains, barriers, or rings) to protect them from the risk of impacts or falls. Special attention must be paid to securing the reducer to avoid accidental rupture risks.
• During transportation in vehicles, cylinders must be securely grouped. Permanent ventilation of the vehicle is mandatory, and smoking is strictly prohibited.

6. Additional Information

Composition of KEOL-S

• The active principle of KEOL-S is Medical Oxygen. The concentration of Medical Oxygen is 21.0 – 22.5% v/v.
• The other component (excipient) is: Medical Nitrogen.

Appearance of the product and packaging content

KEOL-Sis conditioned in cylinders and cylinder blocks. The cylinders can be made of steel, aluminum, or alloys of the following volumes:

A V18 B40 cylinder block conditioned to 150 bar pressure contains 134.46 kg + 5% of gas

A V16 B50 cylinder block conditioned to 150 bar pressure contains 149.44 kg + 5% of gas

A B2 cylinder conditioned to 200 bar pressure contains 0.48 kg + 5% of gas

A B2 Pin-Index cylinder conditioned to 200 bar pressure contains 0.48 kg + 5% of gas

A B3 cylinder conditioned to 200 bar pressure contains 0.72 kg + 5% of gas

A B5 cylinder conditioned to 200 bar pressure contains 1.20 kg + 5% of gas

A B7 cylinder conditioned to 200 bar pressure contains 1.68 kg + 5% of gas

A B10 cylinder conditioned to 200 bar pressure contains 2.40 kg + 5% of gas

A B15 cylinder conditioned to 200 bar pressure contains 3.60 kg + 5% of gas

A B20 cylinder conditioned to 200 bar pressure contains 4.80 kg + 5% of gas

A B40 cylinder conditioned to 200 bar pressure contains 9.59 kg + 5% of gas

A B50 cylinder conditioned to 200 bar pressure contains 11.99 kg + 5% of gas

A V12 B50 cylinder block conditioned to 200 bar pressure contains 143.88 kg + 5% of gas

A V16 B50 cylinder block conditioned to 200 bar pressure contains 195.00 kg ± 5% of gas

A V18 B40 cylinder block conditioned to 200 bar pressure contains 172.62 kg ± 5% of gas

Instructions for use and handling directed to the healthcare professional

In particular:

. Never introduce this gas into a device that may contain combustible materials, especially if they are greasy.

. Never clean with combustible products, especially if they are greasy, either the devices that contain this gas or the valves, gaskets, seals, and closing devices.

. Never apply any greasy material (vaseline, ointments, etc.) to the face of patients.

. Never use aerosols (hair spray, deodorants, etc.) or solvents (alcohol, perfume, etc.) on the material or near it.

The KEOL-S cylinders are exclusively reserved for therapeutic use.

To avoid any incidents, it is necessary to strictly follow the following rules:

1. Verify the good condition of the material before its use.
2. Never force a cylinder into a support that is too narrow for it.
3. Handle the material with clean and grease-free hands.
4. Handle cylinders of 50 liters capacity or more with clean handling gloves and safety shoes.
5. Never handle a cylinder whose valve is not protected by a tulip, except in cylinders of capacity less than 5 liters.
6. Never lift the cylinder by holding the valve.
7. Use specific connections or flexible connection elements for Air.
8. Use a manoreducer with a flowmeter that can withstand a pressure of at least 1.5 times the maximum service pressure of the cylinder (unless there is a reducer incorporated into the valve).
9. In the case of cylinder blocks, use only graduated manometers, at least up to 315 bars.
10. Open the valve progressively.
11. Never force the valve to open, nor open it completely.
12. Purge the outlet connection of the cylinders before incorporating the manoreducer to eliminate any dust that may be present. Keep the connections between the cylinder and the manoreducer clean.
13. Never subject the manoreducer to several successive pressurizations.
14. Never attempt to repair a faulty valve.
15. Close the cylinder valve after use, allow the pressure of the manoreducer to decrease by leaving the flowmeter open, close the flowmeter, and then loosen (except in the case of integrated manoreducers) the manoreducer regulation screw.
16. In case of leakage, close the feeding valve of the circuit that has a leak, and check that the emergency device is activated.
17. Never transfer gas under pressure from one cylinder to another.
18. Ventilate, if possible, the place of use, if it is a reduced location (vehicles).

Marketing Authorization Holder

AIR LIQUIDE SantéINTERNATIONAL

75 Quai d´Orsay

75007 París Cedex 07 (FRANCE)

Manufacturer:

Air Liquide Healthcare España, S.L

C/ San Norberto, 23, 28021

Villaverde, Madrid - Spain

Air Liquide Medicinal S.A

Avenida Vasco Da Gama nº 7375, 4430-755

Avintes - Portugal

Date of the last revision of this leaflet:04/2025