Intended Use - GCE AFNOR Notice D'instructions

ENGLISH
INSTRUCTION FOR USE: TU AFNOR
1. FOREWORD
GCE terminal units are medical devices classifi ed as Class IIb according to
the Directive concerning medical devices (93/42/EEC – MDD 2007/47/EC).
EN
Conformity with essential requirements of the Directive 93/42/EEC – MDD
2007/47/EC is on the basis of the EN ISO 9170-1 standard.

2. INTENDED USE

Terminal units are devices intended for installation on hospital low-
pressure gas distribution systems (2-10 bar). A terminal unit is the site
where operators connect and disconnect the inlet of specifi ed medical
gases for other medical devices, such as medical hoses, fl ow rate meters
and other medical devices through which the given medical gaseous
medium for which the device is designed fl ows.
The terminal unit is designed in such a way that it cannot be interconnected
with a medical device intended for a type of gas other than the one for
which the concerned terminal unit is intended.
TU cannot be placed into operation before these instructions are
thoroughly read and understood.
Operator of TU must be properly trained for such operation
- see chapter 4.
BASIC VARIANTS DIVISION ACCORDING TO THE GAS :
• Oxygen (O2)
• Medical air (AIR)
• Air for running surgical tools (AIR-800)
• Nitrous oxide (N
• Mixtures of the specifi ed gases (e.g. O
• Underpressure (Vacuum)
(VAC)
• Nitrogen (N
• Carbon dioxide (CO
O)
2
)
2
)
2
+ N O)
2 2
2/40