Intended Use - GCE MM40 Mode D'emploi

ENGLISH
INSTRUCTION FOR USE: MM40 STABILIZER
1. FOREWORD
These instructions for use cover essential information for the entire life cycle of the product:
EN
installation,
•
operation and exchange of operation
•
lines,
GCE Medical central gas system is medical device classifi ed as class IIb according
to the Medical Device Directive 93/42/EEC.
Their Compliance with essential requirements of 93/42/EEC Medical Device Directive is based
upon EN ISO 7396-1 and EN 60601-1.

2. INTENDED USE

MM40 - STABILIZER is secondary gas reduction unit intended for use in the hospital gas
distribution system. Reduction unit ensures stabilizing the gas supply that is used in the gas
outlet points. MM40 - STABILIZER is only secondary reduction unit where the primary gas
supply is provided by high pressure gas manifold (such as MM90, MM40), possibly by the
cryogenic tank (LOX).
Together with the reduction unit there must be always installed a medical gas alarm according
to the standard EN ISO 7396-1 (such as Gas Alarm). For more information about the gas alarm
device always read instruction for use delivered with the product.
Gas reduction unit MM40 - STABILIZER must be always installed in compliance with the
standards EN ISO 7396-1, EN 60601-1 and the appropriate national standards.
This instruction for you describes details for the correct and safe use of the gas reduction unit
MM40 - STABILIZER.
Medical gas reduction unit is suitable for: Oxygen, Nitrogen, Medical Air, Nitrous Oxide*, Carbon
Dioxide* and can be also used for air for driving surgical tools and Mixture of gases for medical
applications. This reduction unit is designed for a maximum operating pressure of 16 bar.
Read this instruction before use of the product. Always follow this instruction!
The product shall only be used for the purpose described in this instruction!
The product must be installed by a qualifi ed person and by compliance of all requirements of
EN ISO 7396-1 as amended!
Before use, to guarantee the safety of the patient, check the equipment and the accessories
used with the product, so that data and performance comply with the intended use of the
product!
The product must not, under any circumstances be modifi ed by other than the manufacturer!
The product must not be used for di erent gas than stated on the label.
NOTE: Pictures in this instruction for use are only informative. The real product may look
slightly di erent depending on the variant. Some of the variants may not include all parts
described bellow. Always see Appendix Nr. 1 for technical data.
alarm conditions,
•
maintenance and cleaning,
•
disposal.
•
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