Intended Use - GCE MINISTAR 2 Gebrauchsanweisung

ENGLISH
INSTRUCTION FOR USE: MINISTAR 2
1. FOREWORD
The product complies with essential requirements of 93/42/EEC Medical Device Directive and
EN
2010/35/EU Transportable Pressure Equipment Directive.
The valve is designed according to EN ISO 10524-3 standard.

2. INTENDED USE

Ministar 2 Combination Valves are designed to be fitted to gas cylinders used for medical gas-
es. 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
• Helium
• Carbon dioxide
Ministar 2 combination valve is not intended for use with flammable anaesthetics and sub-
stances.
2.1. PATIENT PROFILE
Ministar 2 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,
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)
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TRANSPORT
2/103
Xenon
Specified mixtures of the gases listed
Air for driving surgical tools
Nitrogen for driving surgical tools
AND STORAGE SAFETY