Intended Use - GCE druva MEDIUNIT Instructions For Use Manual

ENGLISH
INSTRUCTION FOR USE: TU MEDIUNIT
1. FOREWORD
GCE Terminal units (further only as "TU") are medical devices classi-
fied as Class IIb according to the Directive concerning medical devices
EN
93/42/EEC. Conformity with essential requirements of the Directive
93/42/EEC is on the basis of the EN ISO 9170-1, EN ISO 7396-1 standards
and required national standards.
This instruction for use is valid for all other types of TU - DIN, CZ, BSI, SS.

2. INTENDED USE

TU are intended to be used as outlet points at hospital low pressure gas
supply system or at medical emergency ambulances in compliance with
the EN ISO 1789 standard. TU is an outlet point where operators connect
and disconnect an inlet of other gas specified medical devices, such as
medical hoses, flowmeters,etc.
The TU are designed to be gas specific which means that they cannot be
connected to a medical device that is for a different type of gas.
TU cannot be placed into operation before these instructions are thor-
oughly read and understood.
Operator of TU must be properly trained for such operation - see chap-
ter 4.
BASIC VARIANTS OF TU (DIVISION ACCORDING TO THE GAS):
• Oxygen (O
• Medical air (AIR)
• Air for running surgical tools
(AIR-800)
• Laughing gas (nitrous oxide)
(N O)
2
• Carbon dioxide (CO
• Underpressure (Vacuum)
(VAC)
• Nitrogen (N
• Argon (Ar)
• and mixtures of these gases
)
2
)
2
)
2
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