2/20
EN
1. FOREWORD
GCE Sabre Elite is a medical device classifi ed as class IIb according
to the Medical Device Directive 93/42/EEC.
It´s compliance with the essential requirements 93/42/EEC Medical Device
Directive is based upon EN ISO 10524-4 standard.
2. INTENDED USE
Sabre Elite is a low pressure regulator with fl ow-selector and reservoir
device inteded for the administration of medical oxygen in pulses during
oxygen therapy.
The medical device is intended to be used with medical oxygen only.
This product is intended to be fi tted to a medical gas pipeline system in
terminal units in hospital or to a quick connector outlet of medical regulator,
with nominal pressure up to 600 kPa.
3. OPERATIONAL, TRANSPORT AND STORAGE
SAFETY REQUIREMENTS
Follow the instructions of your medical practitioner, the instructions in this
leafl et and the instructions for any equipment used with the regulator to
ensure optimum patient care and safety.
The product and its associated equipment must be prevented from
tipping over and falling.
Always maintain oxygen cleanliness standards.
Use only the product and its associated equipment in a well ventilated
area.
DO NOT smoke near the unit at any time as oxygen encourages fi re, even
in materials which do not normally burn in air.
DO NOT use oil, wax, polish, or grease on any part of Sabre Elite as they
may cause fi re or explosion.
DO NOT use the unit if the ‘next service due’ date on the waist label has
passed.
Use only MEDICAL OXYGEN with Sabre Elite.
DO NOT tamper with the equipment, as this may endanger patients and
will invalidate the warranty.
ONLY use with a single lumen cannula.
ENGLISH
INSTRUCTION FOR USE: SABRE ELITE
