Intended Use - GCE MM40 Mode D'emploi

ENGLISH
INSTRUCTION FOR USE: MM40 - HP UNIT
EN
1. FOREWORD
These instructions for use cover essential information for the entire life cycle of the manifold:
Installation,
•
Operation and bank changeover,
•
Alarm conditions,
•
GCE Medical central gas system is medical device classified 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 standards.

2. INTENDED USE

The MM40 – HP UNIT semiautomatic medical gas manifold is intended for use in hospital
pipeline system as medical gas source and gas pressure reducing unit. Together with
the medical gas manifold shall always be used alarm providing all alarms according to
EN ISO 7396-1 and comply with EN 60601-1 standards. A medical stabilizer (LINE REGULATOR
or MM40 - STABILIZER) can be used together with MM40 – HP UNIT to reduce the pressure
to hospital distribution pressure. The medical stabilizers must be installed according to EN
ISO 7396-1 and EN 60601-1 standards. For more information about accessories (Gas Alarm or
stabilizer) read instruction for use attached to the specific product.
This instruction for use details the operational and safety procedures for the MM40 – HP UNIT.
The medical gas manifold is available for Oxygen, Nitrous Oxide* and Compressed Air, it can
also be used for Carbon Dioxide*, Nitrogen, and gas blends for Medical Applications. These
manifolds are designed to operate at a maximum service pressure of 200 bar**.
Note: In Nitrous Oxide and Carbon Dioxide there is humidity due to the common production
methods, the mounting of a pre-heater per bank (total 2 pre-heaters per manifold) eliminates
possible working difficulty of the manifold. These difficulties are due to the fact that the gas,
when expanding, tends to produce ice.
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 qualified 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 modified by other than the manufacturer!
The product must not be used for different gas than stated on the label.
Pictures in this instruction for use are only informative. According to the variant of the
product, the real product may look slightly different and some below described parts may not
be included in the delivery. Always see appendix Nr. 1 for technical data.
* Manifold shall be installed in room with minimal temperature of 10 °C.
** Maximum service pressure of 200 bar means for use with cylinders filled to a maximum
settled pressure of 200 bar (at 15 °C). At higher temperatures cylinder pressure will exceed
200 bar (developed pressure). For example developed pressure for oxygen at 50 °C is 240 bar.
Maintenance and cleaning,
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Disposal.
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