Intended Use; Patient Profile; User Profile - GCE MediVital Instrucciones De Uso

ENGLISH
INSTRUCTION FOR USE: MEDIVITAL®
1. FOREWORD
The product complies with the essential requirements of 93/42/EEC Medical Device Directive
and Transportable Pressure Equipment Directive 2010/35 EU.
The combination valve is designed according to EN ISO 10524-3 and EN ISO 10297 standards.

2. INTENDED USE

MediVital Combination Valves are designed to be fitted to gas cylinders used for medical
®
gases. These combination valves together with a gas cylinder form gas packages used either
as gas supply point for medical devices (anaesthetic devices, ventilating devices, incubators
etc.) or for direct gas supply to a patient's breathing mask or cannula.
GCE Combination Valves are intended to be used with the following medical gases:
• Oxygen
• Nitrous oxide
Air for breathing
•
MediVital combination valve is not intended for use with flammable anaesthetics and
®
substances.

2.1. PATIENT PROFILE

Medivital® supplies medical gas by means of the control flow head in flow range from 0 to 15
(25) l/min. Saturation of the medical gas must be prescribed by the doctor or an anaesthetic
nurse who has got the medical education, assessed the heath status of the patient and supplies
him with required amount of the medical gas.
Health status - the assesment and decision about the use timing and dosage amount
requirements of the patient is up to the doctor or medical personnel.
Medical personnel - nurse, rescuer, paramedic or carer who has obtained medical education.

2.2. USER PROFILE

Use in the hospital or ambulance:
• Education: personnel with medical education
Home care use:
Therapy is prescribed by a doctor or personnel who has got a medical education in the field of
breathing support:
• Knowledge: training of personnel with medical education who has got an ability to read, train
and apply knowledge from the instruction for use.
Training must be performed according to regulations valid in each country.
Important:
Patient must be trained by the doctor or person who has got an education in the life saving.
3. OPERATIONAL, TRANSPORT AND STORAGE SAFETY
REQUIREMENTS
KEEP THE PRODUCT AND ITS ASSOCIATED EQUIPMENT AWAY FROM:
• Heat sources (fire, cigarettes,...)
• Flammable materials
• Oil or grease (take a great care in the use of hand creams)
• Water
• Dust
• Helium
• Carbon dioxide
Mixtures of the gases listed above
•
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EN