Intended Use; User Profile - GCE MediVitop Mode D'emploi

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

2. INTENDED USE

MediVitop® 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, flowmeters,
suction ejectors, incubators etc.) or for direct gas supply to a patient's breathing mask, cannula
or humidifier.
GCE Combination Valves are intended to be used with the following medical gases:
Oxygen
•
Nitrous oxide
•
Air for breathing
•
Helium
•
Carbon dioxide
•
Xenon
•
Specified mixtures of the gases listed
•
2.1. PATIENT PROFILE
Regulator valve get gas flow from 0 to 25 liter per minutes. Information about specification flow
rate you can find in the appendix No. 1 of instruction for use. Flow rate is listed in the Appendix
No. 1 of instruction of use in the table on the position C and this Appendix is supplied to every
product.
The saturation of gas must be estimated by doctor or anesteziologic nurse. They have nec-
essary education, where they must know health status of patient and get him important gas
support.
Health status - used, when the patient will be need to support of medical gases for supporting
breathing and decision about treatment is on the side doctor or health personal.
Health personal – nurse, rescuer, paramedic, keeper or person with medical education.

2.2. USER PROFILE

Use in a hospital or in an ambulance
Education: personal with medical education
•
Use in home care
Treatment is description from a doctor or personal with medical education or who set this sup-
porting of breathing
Knowledge: training from person with medical education ability to read, study and knowl-
•
edge of user manual
Training is provided according to local law in individuals countries.
Important:
The patient must be trained by doctor or person, who has education on the field of safe life.
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