GCE druva SIMPLEX MMR User manual

INSTRUCTIONS FOR USE
ANVÄNDARANVISNING
NÁVOD K POUŽITÍ
BEDIENUNGSANLEITUNG
GCE CENTRAL GAS SYSTEMS
CENTRAL GAS SUPPLY SYSTEM
CENTRALGASANLÄGGNING
EN
SV
SIMPLEX MMR
CENTRÁLNÍ ROZVODOVÝ SYSTÉM
ZENTRALES GASVERSORGUNGSSYSTEM
CS
DE

SIMPLEX MMR
CONTENT
ENGLISH. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
SVENSKA ............................... 13
ČESKY................................... 24
DEUTSCH................................ 35

EN
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1. FOREWORD
These instructions for use cover essential information for the entire life cycle of the manifold:
• Installation,
• Operation and cylinders changeover,
• Alarm conditions
• Maintenance and cleaning,
• Disposal.
GCE Medical central gas system is medical device classified as class IIb according to the Medi-
cal Device Directive 93/42/EEC.
Their Compliance with essential requirements of 93/42/EEC Medical Device Directive is based
upon EN ISO 7396-1 standard.
2. INTENDED USE
The Simplex MMR gas manifold is suitable for health care where the capacity requirement is
limited, such as laboratories, small health care clinics, veterinary etc. This gas manifold consists
of one group of cylinders only.
Regulator is mounted to collection unit MANYFLOW. Each inlet connection of MANYFLOW has
a filter, non-return valve and shut-o valve. This arrangement enables using one cylinder at a
time.
In order to obtain a stabile outlet pressure this gas manifold is equipped with a pre-
set two-stage regulator. On the high pressure side of the regulator there is a con-
tact gauge. Signal of contact gauge can be carried further to an alarm unit.
Simplex MMR is delivered mounted and test-pressurized.
This instruction for use details the operational and safety procedures for the SIMPLEX MMR.
Medical gas manifold 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 200 bar**.
SIMPLEX MMR must not be used in other cases than mentioned above (chap. 2).
SIMPLEX MMR must not be used for dierent gas than stated on the label placed on the
regulator.
Pictures in this instruction for use are only informative. According to the variant of the prod-
uct, the real product may look slightly dierent and some below described components 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 set-
tled 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.
The marking to be read on the regulator or manifold product label refer to max settled cylin-
der pressure not developed cylinder pressure, this should match the pressure marking on the
cylinder.
ENGLISH
INSTRUCTIONS FOR USE: SIMPLEX MMR

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EN
3. OPERATIONAL, TRANSPORT AND STORAGE SAFETY RE
QUIREMENTS
KEEP THE PRODUCT AND ITS ASSOCIATED EQUIPMENT AWAY FROM:
• heat sources (fire, cigarettes, ...)
• flammable materials,
• oil or grease (especially be careful if hand cream is used),
• water,
• dust.
The product and its associated equipment must be prevented from falling.
Always maintain oxygen cleanliness standards,
Use only the product and its associated equipment in a well ventilated area.
Before initial use the product shall be kept in its original packaging.
GCE recommends use of the original packaging (including internal sealing bag and caps) if the
product is withdraw from operation (for transport, storage).
The product provider or user must ensure that during the product life cycle transport and stor-
age environmental conditions are in accordance with the above “Safety instruction” section
requirements, in order to maintain product integrity and cleanliness. Statutory laws, rules and
regulations for medical gases, accident prevention and environmental protection must be ob-
served.
OPERATING CONDITIONS STORAGE AND TRANSPORT
CONDITIONS
MIN MAX MIN MAX
-20 °C* +60°C -30 °C +60 °C
20 % 70% 20 % 70 %
600 mbar 1200 mbar 600 mbar 1200 mbar
It’s very important to assure that the device can be only accessed by a qualified person –
possibility of misuse.
3.1.OPERATIONAL SAFETY
The panel described in this manual is to be used for cylinder gases and the following general
practices are our recommendations for the safe, ecient storage and use of such compressed
gases.
3.2.CYLINDER STORAGE
Storage area shall be designed according to valid standard, here are some recommendations:
• well ventilated with weather protection,
• free from fire risk. Keep away from sources of heat and ignition. Designated as a ‘no smoking’
area. Clearly marked as a gas store with appropriate hazard warning signs (e.g. flammable,
toxic, etc.).
• kept clear with access restricted to authorised personnel,
• provided with appropriate safety/emergency equipment (e.g. Fire extinguisher, breathing
apparatus etc.),

EN
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3.3.COMPRESSED GAS CYLINDERS IN STORAGE SHOULD BE:
• standing upright where designed for this.
• properly secured to prevent overturning.
• fitted with valve protection devices (e.g. caps, guards etc.) where supplied.
• segregated in the storage area according to the various categories (e.g. flammable, oxidant
etc.).
• segregated in the storage area according to content and clearly designated full or empty.
• managed to ensure that the oldest stock is used first.
• checked periodically for general condition.
3.4.PERSONNEL: WHO ENTER THE STORAGE AREA SHOULD BE:
• responsible and competent to maintain the gas store and its contents as above.
• familiar with and able to identify the contents of the gas containers and their potential hazards.
3.5.EMERGENCY PROCEDURES:
AN EMERGENCY RESULTS FROM:
• a fire near or in the cylinder manifold room.
• an unintended leak of gas from the cylinders or pipeline.
• some other potential or actual incident which will aect the integrity of the manifold installation.
PROCEDURE TO FOLLOW:
• Raise the alarm and notify a supervisor and/or call the fire brigade.
• Evacuate all personnel from the immediate danger area.
IN CASE OF FIRE, REMOVE ALL CYLINDERS:
• Close the cylinder valve(s) on all cylinder(s)/ cylinder bundles.
• Close the bank isolating valve(s).
• Disconnect the high pressure hoses.
• Move the cylinders to a safe area using a suitable cylinder trolley.
IN THE CASE OF AN UNCONTROLLABLE ESCAPE OF GAS:
• Open the doors to the manifold room to ventilate the area.
• Do not introduce sources of ignition into the area.
It is important that ready access to these instructions is given at all times and that the mani-
fold is not put into operation until the operator is fully familiar with its functions, controls and
safety precautions.
It is the duty of all employers to provide such information, training and supervision according
to national standards that are necessary to ensure so far as is reasonably practical the health
and safety at work of its employees.
4. PERSONNEL INSTRUCTIONS AND TRAINING
The Medical Devices Directive 93/42/EEC states that the product provider must ensure that all
personnel using the product are provided with the instructions for use and are fully trained in
the use of the equipment.
Do not use the product without proper training! Trainees must be trained by an experienced
person who has been authorised by the manufacturer and has an appropriate education,
knowledge and experience.
For further information about training of responsible personnel, please contact GCE.