GCE MM40 Istruzioni per l'uso

GCE HEALTHCARE

CENTRAL GAS SUPPLY SYSTEM

CENTRÁLNÍ ROZVODOVÝ SYSTÉM

SYSTEME CENTRAL DE DISTRIBUTION DE GAZ

CENTRALGASANLÄGGNING

SISTEMA CENTRALIZODO DE SUMINISTRO DE GAS

CENTRALNY SYSTEM ZASILANIA GAZEM

CENTRAAL GASTOEVOERSYSTEEM

CENTRALE EROGAZIONE GAS MEDICALE

KÖZPONTI GÁZELLÁTÓ RENDSZER

ZENTRALES GASVERSORGUNGSSYSTEM

MM40  HP UNIT

EN

CS

FR

SV

ES

PL

NL

INSTRUCTION FOR USE

NÁVOD K POUŽITÍ

MODE D‘EMPLOI

ANVÄNDARANVISNING

INSTRUCCIONES DE USE

INSTRUKCJA OBSŁUGI

GEBRUIKSAANWIJZING

ISTRUZIONI PER L‘USO

HASZNÁLATI UTASÍTÁS

BEDIENUNGSANLEITUNG

IT

HU

DE

2/164

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,

• Maintenance and cleaning,

• Disposal.

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 diculty of the manifold. These diculties 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 dierent 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 dierent 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.

ENGLISH

INSTRUCTION FOR USE: MM40  HP UNIT

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EN

The marking to be read on the regulator or manifold product label refer to max settled cylinder

pressure not developed cylinder pressure, this should match the pressure marking on the

cylinder.

3. OPERATIONAL, TRANSPORT AND STORAGE SAFETY

REQUIREMENTS

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 owner or user must ensure that during the product life cycle transport and storage

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

observed.

OPERATING CONDITIONS STORAGE AND TRANSPORT

CONDITIONS

MIN MAX MIN MAX

*+10 °C +60°C -30 °C +70 °C

10 % 100% 20 % 70 %

600 mbar 1200 mbar 600 mbar 1200 mbar

It’s very important to assure access to this device only for qualiﬁed person – possibility of

misuse.

3.1. OPERATIONAL SAFETY

The panel described in this manual is for cylinder gases and the following general practices are

our recommendations for the safe, ecient storage and use of such compressed gases.

3.1.1. 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.)

4/164

EN

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.

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.

3.1.2. 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 as is necessary to ensure so far as is reasonably practical the health and

safety at work of its employees.

4. PERSONNEL INSTRUCTIONS

The Medical Devices Directive 93/42/EEC states that the product provider must ensure that

all personnel handling the product are provided with the operating instructions & performance

data.

Do not use the product without properly familiarization of the product and its safe operation

as deﬁned in this Instruction for use. Ensure user is aware of particular information and knowl-

edge required for the gas in use.

5. PRODUCT DESCRIPTION

The manifolds covered by these instructions are designed to allow equal numbers of cylinders

to be manifold together to give an operating bank and a reserve bank. The operating bank will

deliver gas to the manifold pressure regulator until the cylinders are exhausted. At that point the

supply will switch to the reserve bank and the exhausted bank can be replenished. The object

is to give uninterrupted gas supply.

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EN

5.1. HIGH PRESSURE SIDE OF THE MANIFOLD:

I1, I2  INLET CONNECTIONS

The manifold contains left and right side threaded inlet connection that ﬁts to the high pressure

hoses.

F1, F2  FILTERS

The manifold contains two high pressure ﬁlters which are installed on the inlets of the manifold.

These ﬁlters can be easily maintained. Filters include antishock valves that prevent a backﬂow.

Antishock vlaves are not leaktight.

V1, V2  INLET SHUT OFF VALVES

The manifold contains two inlet shut o valves that are used to open and close the main high

pressure on the left and right side of the manifold unit. By these two valves you can close gas

supply to the hospital pipeline.

V3, V4  PURGE VALVES

The manifold contains two purge valves. Through the purge valves is ventilated high pressure

collecting pipelines on the empty side before removing high pressure hoses from the cylinders.

Also purge valves are used for cleaning of collecting pipeline before opening inlet shut o valve

and supply gas to the main pipeline. Outlet of purge valve has a threaded connection.

R1, R2  REGULATORS

The manifold consists of two high pressure manifold regulators. The regulators reduce the

pressure from cylinder pressure to the outlet pressure setting on manifold outlet. Information

about setting of product you can ﬁnd in testing report included to the product.

O1

T3, T4

S1, S2

V5

R1

T1

M1

V3 V1

M3 V6

R2

M2

T2

V2 V4

T5

L

T6

P1, P2

F1

I1

E1

V10

F2

I2

Fig. 1

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EN

M1, M2  INLET GAUGES

Each regulator R1 and R2 is equipped with high pressure gauge. These gauges show pressure

in the left and right collecting pipelines. If the product is equipped with contact gauges then

these gauges send information about pressure to the alarm system.

T1, T2  PRESSURE SENSORS

Pressure sensor is installed in each pressure regulator. Main function is to check a leakage on

reserve side and sends information to the alarm. When leakage on reserve side is detected by

pressure drop then alarm starts inform the technical personal. Variant with the transmitters send

information about pressure to the alarm unit.

5.2. LOW PRESSURE SIDE OF THE MANIFOLD:

S1, S2  SAFETY VALVES

The manifold contains two safety valves on each side. When the outlet pressure increase up to

pre-set limit, the safety valve activates and gas is purged out. According to the version can be

equipped with safety valves with manual drain.

P1, P2  PLUGS FOR SERVICING PURPOSES

Instead of these plugs (G1/4”) an external low pressure gauge or other device can be used to

check the manifold parameters, such as outlet pressure or closing pressure.

E1  PURGE PIPE FROM SAFETY VALVES

Purge pipe from safety valves have external dimension 10 mm. The purge pipe must go outside

of the manifold room as is described in installation standard.

V5, V6  SERVICE VALVES

The manifold contains two service valves. These valves are only used for the service. It is not

allowed to operate the service valve with exception of trained service technician. Using these

valves is possible to service the manifold without interruption of the gas supply.

T3, T4  PRESSURE SENSORS

Pressure sensor installed in the outlet block to the slot with marking LP sends information to

the alarm about empty of supplying side. Pressure sensor installed in the slot with marking HP

sends information to the alarm about too high outlet pressure. Variant with pressure transmitter

has only one sensor and other side is sealed only by a plug. Transmitters send information

about pressure to the alarm unit.

M3  OUTLET GAUGE

Outlet block is equipped with outlet gauge. The gauge shows outlet pressure of the manifold

that is supplied to the stabilizer. If the product is equipped with contact gauge then the gauge

sends information about preset pressure to alarm system.

V10  OUTLET SHUT OFF VALVES

Gas supply to the hospital pipeline system from the manifold unit is possible to close by outlet

shut o valve.

T5, T6  MICRO SWITCHES

The manifold contains two micro switches that control the lever position. When the lever is in an

incorrect position Gas Alarm informs the technical personnel.

O1  OUTLET CONNECTION

Outlet connecting must be soldered to the pipeline. Outlet connection is equipped with male

thread G1/2.

L  LEVER

Manual lever is control part of the manifold that makes it possible to decide which side is an

operational and which side is a reserve one. When the manual lever is in upper position left side

is the operational and right side is as the reserve. When the manual lever is in lower position

right side is the operational and left side is as the reserve. The MM40 semiautomatic medical

manifold can be delivered with HP accessories. The accessories contain parts for connecting

gas cylinders. Basic parts of accessories are in picture bellow.

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EN

5.2.1. GAS MANIFOLD HIGH PRESSURE ACCESSORIES

P3, P4  CONNECTION POINTS

The accessories contains two connecting points for connecting to the pipelines.

P11, P12  COLLECTING PIPES

Collecting pipes are used for connecting gas cylinders to the manifold. Two equal parts one left

and one right of these pipes should be included to the HP unit.

V13, V14  INLET SHUT OFF VALVES ON COLLECTING PIPES

If collecting pipes are used, inlet shut o valves and antishock valves shall be included. Shut o

valves stops the gas supply between each cylinder and the collecting pipes. Antishock valves

prevent a back ﬂow, they are not leaktight.

H1  CYLINDERS HOLDERS

The accessories can contain cylinders holders. Cylinder holders are used for prevention of the

gas cylinders from falling over.

6. INSTALLATION

It is necessary that an installer of the product is trained and has an appropriate licence ac-

cording to national standards. It is outside the scope of these operating instructions to give

detailed guidance on installations.

The installation must conform to the standard MEDICAL GAS PIPELINE SYSTEMS EN ISO

7396-1 as amended. All tests according this standard have to be fulﬁlled.

P12P11

P3 V13 P4

H1

V14

Fig. 2

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EN

When working with medical gases it is essential that no oil or grease come into contact with

the gas. This means that hands, tools and work clothes be free from oil or grease before any

work is undertaken. Components used for service must be gas compatible. For oxygen ser-

vice must also be degreased and although they will reach you in this condition care must be

taken during storage and handling.

6.1. WALL FIXING

Positioning of the manifold, please consult with responsible central gas system designer. Mount

the manifold at the height to suit either cylinders or cylinder bundles.

The holes to use for mounting the manifold are shown in Fig. 3.

Be aware that only upper screw is holding the entire weight of the manifold. Size of used

screws shall conform to total load.

6.2. FITTING OUTLET CONNECTION

Solder diameter pipe 15 mm.

6.3. FITTING SAFETY VALVE

Solder diameter pipe 10 mm. The pipes from safety valve and purge valves can (by use of a

T-coupling) be soldered together and have a common outlet outside the manifold room.

6.4. PURGE VALVES OUTLET

Outlet thread W21,8 x 1/14 male. The pipes from safety valve and purge valves can (by use of a

T-coupling) be soldered together and have a common outlet outside the building.

6.5. FITTING TAILPIPES / HIGH PRESSURE HOSES / COLLECTING

BRANCH

• Screw tailpipes / high pressure hoses from cylinders or cylinder bundles / collecting branch

together and then onto the inlet connections on the manifold. Ensure that the shut-o valves

V1 & V2 and the purge valves V3 & V4 are in closed position.

• Open one cylinder from one bank SLOWLY.

Fig. 3

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EN

• Check connection between tailpipe and inlet connection for leakage using a leak detection

ﬂuid.

• If no leakage is detected, open remaining cylinders slowly from that bank. Repeat operation

on opposite bank.

Note: if leakage occurs between tailpipe/high pressure hose/collecting branch and inlet

connection check to see if sealing’s or washers are ﬁtted correctly or missing. If it is damaged

change the sealing and try again.

6.6. FITTING TO SOURCE OF ELECTRICITY

Any work with electric wiring must be carried out by a trained person with an appropriate

licence according to national standards.

Act upon instruction for use for gas alarm.

The product must be grounded through the anchor bolt at the protective earth label.

6.7. CHECKING OF GAS LABEL

The gas label shall be placed on the cover and on the back plate. Check in Appendix Nr. 1 -

Technical data, what type of gas can be used for this product. If a wrong gas label has been

placed on the product it is necessary to exchange it for the correct one. Optional gas labels are

part of the delivery.

6.8. STARTING UP THE MANIFOLD

Detailed description how to start up the manifold can be found in chapter 7.1.

6.9. REGULATORS SETTINGS

Setting of the manifold is in the Testing report - see appendix Nr. 1. You can set dierent

parameters - see below mentioned description.

When the manifold is completely installed the outlet pressure shall be checked. You can change

outlet pressure from regulators.

SETTING CONDITION:

Set left and right regulators with full cylinders or cylinder bundles. Inlet pressure of left and

right manifold side should be the same. Inlet pressure should be min. 180 bar and ﬂow equal

to 8 m3/h.

SETTING LIMITS

Set left and right side for same outlet pressure:

• max. outlet pressure for operating side is 12 bar. (Pressure sensor T3 marked LP must be set 1

bar below the outlet pressure of operating side.)

• min. outlet pressure for reserve side is 7 bar.

SETTING PRESSURE ON REGULATORS

• Place lever L into the left position (lever is pointing up).

• Loose thread B to loosen the lever L from the clamp of control screws of the regulators C1 &

C2.

• Set required outlet pressure on left regulator using control regulator screw C1 (tighten eect

upper pressure, loosen efect lower pressure) and observing the outlet gauge M3.

• Tighten lever L to clamp of control screw of regulators in the original position, micro switch T6

have to be switched on in this position.

• Place lever L into the right position (lever is pointing down).

• Loose thread B to loosen the lever L from the clamp of control screws of the regulators C1 &

C2.

• Set required outlet pressure on left regulator using control regulator screw C2 (tighten eect

upper pressure, loosen eect lower pressure) and observing the outlet gauge M3.

• Tighten lever L to clamp of control screw of regulators in the original position, micro switch T5

have to be switched on in this position.

• Check again outlet pressure for left and right side of manifold, if is necessary repeat setting

procedure.

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EN

7. OPERATION

7.1. START UP OF MANIFOLD

When the manifold is completely installed and the parameters are checked.

• Check that shut o valves V1 & V2, V5 & V6 and V10 are closed.

• Check that both purge valves V3 & V4 are closed.

• SLOWLY open gas ﬂow from cylinders or cylinder bundles into the inlets I1 & I2.

• SLOWLY open purge valves V3 & V4 and purge left and right inlet part of the manifold.

• Close purge valves V3 & V4.

• SLOWLY open inlet shut o valves V1 & V2. The cylinder pressures can be read on the gauges

M1 & M2.

• SLOWLY open service valves V5 & V6. The outlet pressure can be read on the gauge M3.

• SLOWLY open outlet shut o valve V10. The gas supply will start ﬂowing into the pipeline

through outlet connection O1.

• Decide by moving the lever L, if right or left bank of cylinders should start to supply. Always

start supply from the bank that has the lowest pressure.

Info: Two micro switches T5 & T6 are ﬁtted to the back plate to electrically decide which side

is monitored for leaking reserve.

• Check all connections for leakage using a leak detection ﬂuid.

• While gas is ﬂowing the pressure in the operating side will fall. This will be indicated on the

inlet gauges M1 or M2.

7.2. BANK CHANGE OVER

At a predetermined pressure set of the manifold regulators of 10,5 bar, the reserve bank will

take over from the near empty bank of cylinders. You will have an alarm “Change of operating

side”. It is indicated by pressure switches. (See Chapter 8 – Alarm conditions).

7.2.1. LEFT HAND LH SIDE EMPTY

• The inlet pressure gauge M1 on the left-hand side is indicating exhausted cylinders, so the

left-hand bank of cylinders needs to be replaced.

C2C1

BL

Fig. 4

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EN

• Close gas source shut o valve (cylinder or cylinder bundles) on the left hand side prior to

inlet connection I1.

• Close shut-o valve V1.

• SLOWLY open purge valve V3 to vent any excess gas within the high pressure hose.

• Close purge valve V3 and disconnect high pressure hose from cylinders or cylinder bundles.

• Replace empty cylinders with full ones.

• Reconnect high pressure hose to cylinders or cylinder bundles. Use new gaskets, lubricate

with grease approved for high pressure oxygen up to 250 bar (like lubricant).

• SLOWLY open gas source shut o valve and leak test joints with a leak detection ﬂuid.

• SLOWLY open purge valve V3 for 5 seconds to vent “AIR” within the high pressure hose.

• Close purge valve V3.

• Change the position of the lever L, to give normal operation to right-hand side (lever pointing

down), and open shut o valve V1 and read the full content of the new cylinders on the inlet

gauge M1. The alarm condition “Change of operating side” will hereby be cancelled.

• The left hand side is now the reserve bank with full cylinders.

7.2.2. RIGHT HAND RH SIDE EMPTY

• The inlet pressure gauge M2 on the right-hand side is indicating exhausted cylinders, so the

right-hand bank of cylinders needs to be replaced.

• Close gas source shut o valve (cylinder or cylinder bundles) on the right hand side prior to

inlet connection I2.

• Close shut o valve V2.

• SLOWLY open purge valve V4 to vent any excess gas within the high pressure hose.

• Close purge valve V4 and disconnect high pressure hose from cylinders or cylinder bundles.

O1

T3, T4

S1, S2

V5

R1

T1

M1

V3 V1

M3 V6

R2

M2

T2

V2 V4

T5

L

T6

P1, P2

F1

I1

E1

V10

F2

I2

Fig. 1

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EN

• Re-place empty cylinders with full ones.

• Re-connect high pressure hose to cylinders or cylinder bundles. Use new gaskets, lubricated

with grease approved for high pressure oxygen up to 250bar (like lubricant).

• SLOWLY open gas source shut-o valve and leak test joints with a leak detection ﬂuid.

• SLOWLY open purge valve V4 for 5 seconds to vent “AIR” within the high pressure hose.

• Close purge valve V4.

• Change the position of the lever L, to give normal operation to left-hand side (lever pointing

up), and open shut-o valve V2 and read the full content of the new cylinders on the inlet

gauge M2. The alarm condition “Change of operating side” will hereby be cancelled.

• The right hand side is now the reserve bank with full cylinders.

7.3. SHUT DOWN

It is possible shut down the manifold only with responsible person agreement in compliance

with EN ISO 7396-1.

• For short term (hours) shutdown close shut-o valves V1 & V2.

• For long term (days) shutdown close shut-o valves V1 & V2 and the cylinder shut-o valves.

8. ALARM CONDITIONS

8.1. ALARM PROCEDURE

On signal of alarm condition the appropriate visual indicator is illuminated on the alarm unit. The

alarm condition shall be recorded and the necessary action taken, as detailed in the sections

below.

8.2. STATUS INDICATED BY GAS ALARM

Always use instruction for the Gas Alarm.

8.2.1. LEAKING RESERVE SIDE RIGHT LEAKAGE OR LEFT LEAKAGE

The alarm starts in following situations:

a) Reserve side pressure is too low

• Allocate the leakage using leak detecting ﬂuid. Isolate the leaking area and do repair/change

component or washer.

b) Lever L is not in correct position

• Check if the lever L is in correct position.

• Check that the audible and visual alarms on the Gas Alarm have been cancelled.

8.2.2.CHANGE OF OPERATING SIDE

The alarm starts in following situations:

a) The supplying side is empty

• Replace the empty cylinders with full cylinders as described in chapter 7.

• Check that the audible and visual alarms on the alarm have been cancelled.

8.2.3. HIGH OUTLET PRESSURE

The alarm starts in following situations:

a) The manifold outlet pressure is too high (version with safety valves without manual drain)

• Contact authorised service to replace the regulator with a new or refurbished one.

b) The manifold outlet pressure is too high (version with safety valves with manual drain)

• Check that the manifold regulator R1 & R2 outlet pressure is as preferred. If not, isolate the

regulator by closing valve V5 or V6 and check one regulator at a time. Start with the regulator

on reserve side, relief the pressure by the safety valve S1 & S2 and check if the pressure

increases again. Change operating side and make the same test with the other regulator.

• If you shortly after resetting the regulator have the same alarm condition again, the regulator

most likely has internal leakage. Contact authorised service for replace the regulator with a

new or refurbished unit.

• Check that the audible and visual alarms on the Gas Alarm have been cancelled.

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EN

9. ROUTINE MAINTENANCE INSTRUCTION

Routine maintenance shall be carried out only by authorized person according to national

standards. Use only original GCE components. Contact GCE for further information about repair

procedures.

9.1. THE FOLLOWING ROUTINE CHECKS

- should be made on a weekly basis:

• Check all valves for correct operation and leak test using a laek detection ﬂuid.

• Check pipe work for leaks using a leak detection ﬂuid.

• Check that all notices are in place, can be easily read and are not obstructed from view.

• Inspect the vicinity of cylinders for anything introduced since last inspection, which could

aect the continuing safe operation of the manifold.

9.2. GENERAL MAINTENANCE

- should be undertaken in accordance with a planned maintenance schedule, which should

include the following items:

• Leak test all connections using a leak detection ﬂuid.

• High pressure hoses should receive particular attention to ensure they are secure, not worn

or otherwise weakened.

• Components with limited lifetimes, such as high pressure hoses, should be subjected to a

routine replacement programme.

• Filters are in good condition and not blocked. Filter elements may need to be cleaned or

renewed and pipelines may need to be blown through to remove foreign material.

• Valves to be used in normal or emergency operation are accessible and easy to operate.

Valves at service point’s outlets and purge valves should be checked for gas tightness.

• The setting and operation of regulators is satisfactory.

• The necessary safety devices and instruments are ﬁtted, are of the correct type and do not

show signs of deterioration or not authorized interference.

• The equipment downstream of the outlet point is suitable for further service.

• Check connecting nuts and seating faces are undamaged.

• Check gauges operate smoothly and zero correctly.

• Check isolating valves for closure tightness and gland leakage.

• The gas manifold room must always remain thoroughly clean. Materials other than those

required for operating the manifold must not be stored in the room.

• Replace all worn or damaged parts with original spare parts. Remember that gaskets, o-rings

and sealing surfaces must be clean and free from damage to work eectively.

Safety note-as part of the planned maintenance special checks should be made to ensure:

All changes (including removal and addition of parts) and extensions conform to the right code

of practice.

Changes in the vicinity of the installation do not aect the safety of the operation e.g. proximity

of electricity to fuel gases, oils and combustibles near to oxygen, illicit use of a pipeline as an

electrical conductor or as a support for other items.

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10. SCHEME OF EXAMINATION

GCE recommendations for a Written Scheme of Examination:

EQUIPMENT EXAMINATION INTERVAL

1. High pressure hoses Examine when changing cylinders. Replace every 5 years

2. Pipe connections 1 year

3. Safety Relief Valve 1 year

4. Regulator 1 year

5. Non Return Valves 1 year

6. Valves 1 year

7. Alarm system Check when changing cylinders.

8. Filters 1 year

11. ACCESSORIES AND SPARE PARTS

Standard accessories are alarm and stabilizer (MM40 - STABILIZER or LINE REGULATOR).

Contact supplier of the system or GCE dealer for spare part lists. Use only GCE original spare

parts.

Use only GCE original spare parts!

12. CLEANING OF EXTERNAL PARTS

Remove dirt with a soft cloth damped in oil free oxygen compatible soap water and rinse with

clean water. If other cleaning solutions are used, check that they are not abrasive and that they

are compatible with: Cu, Fe, Al alloy, brass, plastic materials of components, labels and gas.

Do not use cleaning solutions containing ammonia!

Do not immerse in water or any liquid.

Do not clean electrical connections when the power is on. Make sure the connections are dry

before turning power back on.

13. LIFETIME, REPAIR AND DISPOSAL

13.1. LIFE TIME AND WASTE MANAGEMENT

The maximum life time of the product is 10 years at compliance of Examination schedule

(chapter 10). At the end of the product’s life time, the product must be withdrawn from service.

The owner of the device shall prevent the reuse of the product and handle the product in

compliance with “Directive of European Parliament and Council 2008/98/EC on waste“.

In accordance to Article 33 of REACH GCE, s.r.o. as responsible manufacturer shall inform all

customers if materials containing 0.1% or more of substances included in the list of Substance

of Very High Concern (SVHC).

The most commonly used brass alloys used for bodies and other brass components contain

2-3% of lead (Pb), EC no. 231-468-6, CAS no. 7439-92-1. The lead will not be released to the gas

or surrounding environment during normal use. After end of life the product shall be scrapped

by an authorized metal recycler to ensure ecient material handling with minimal impact to

environment and health.

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To date we have no information that indicates that other materials containing SVHC of

concentrations exceeding 0.1% are included in any GCE product.

13.2. MANUFACTURING DATE

The manufacturing date is included in product serial number which is marked on back plate.

Serial number composition is the following: YYMMXXXXX

Y: 2 last numbers of the year of manufacture

M: month of manufacture

X: production number

The perforation in the device label indicates the year when the equipment has to be disposed

o.

13.3. REPAIR

Repair activities of GCE product must be carried out by GCE or authorized repair centers.

Contact GCE for further information about service available in your area.

All labels on the equipment must be kept in good, legible condition by the owner and the

user during the entire product life time.

Use only genuine GCE components.

13.4. DISPOSAL AT THE END OF THE PRODUCT’S LIFE TIME

Product must be recycled in compliance with the national and local regulations.

No part contains any chemical materials burdensome environment.

14. GLOSSARY

Consult instruction for use Take back equipment for

recycling. Do not dispose

equipment into unsorted

municipal waste

Caution!

Keep away from heat and

ﬂammable materials Suitable for Hospital care use

Keep away from oil and

grease!

Take back battery

for recycling

Humidity limit SN Serial number

Temperature limit REF Catalogue number

Keep dry! LOT Batch code

Date of manufacture Manufacturer

Use by date Fragile, handle with care

Inlet parameter Outlet parameter

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P1Inlet pressure range P2Outlet pressure

P4

Max outlet pressure (closing

pressure) QOutlet ﬂow

Service or disposal date The

serial number indicates the

year product has to undergo

the overall maintenance ac-

tivities or has to be disposed

o. Refer to the serial number

note to determine the Overall

maintenance or disposal.

Weight of product

Atmospheric pressure limit

The protective earth label

15. WARRANTY

The Standard Warranty period is two years from date of receipt by the GCE Customer (or if this

is not known 2 years from time of the product manufacture shown on the product).

The standard warranty is only valid for products handled according to Instruction for use (IFU)

and general industry good practice and standards.

APPENDIX:

Nr 1 - Technical speciﬁcation and performance data

Nr 2 - Testing report for relevant number of reduction unit– Serial Number

MANUFACTURER:

GCE, s.r.o. Tel: +420 569 661 111

Zizkova 381 Fax: +420 569 661 602

583 01 Chotebor http://www.gcegroup.com

Czech Republic © GCE, s.r.o.

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1. PŘEDMLUVA

Tento návod k použití poskytuje nezbytné informace pro celý životní cyklus výrobku:

• instalace,

• provoz a změna provozních stran,

• alarmové podmínky,

• údržba a čištění,

• likvidace.

GCE medicinální rozvodové systémy jsou zdravotnickými prostředky klasiﬁkovanými ve třídě IIb

dle Medicinální Direktivy 93/42/EHS.

Splnění základních požadavků Medicinální Direktivy 93/42/EHS je založeno na výrobních

normách EN ISO 7396-1 a EN 60601-1.

2. ÚČEL POUŽITÍ

Poloautomatická medicinální redukční stanice MM40-HP UNIT je určena k použití v rozvodových

systémech nemocnic jako zdroj medicinálního plynu a jednotka pro redukci tlaku plynu.

Společně s redukční medicinální stanicí musí být vždy použit signalizační zařízení (Gas Alarm),

které je v souladu s normami EN ISO 7396-1 a EN 60601-1. Společně se stanicí MM40-HP UNIT

může být použit také medicinální stabilizér (LINE REGULATOR nebo MM40-STABILIZER) pro

snížení tlaku, který je distribuován do distribučního systému nemocnice. Medicinální stabilizér

musí být instalován v souladu s normami EN ISO 7396-1 a EN 60601-1. Pro více informací o

příslušenství (Gas Alarm nebo Stabilizer) čtěte návod k použití pro daný produkt.

Tento návod k použití detailně popisuje provozní a bezpečnostní postup pro použití stanice

MM40-HP UNIT. Medicinální rozvodová stanice je k dispozici pro kyslík, oxid dusný*, a stlačený

vzduch, může být také použita pro oxid uhličitý*, dusík a směs plynů pro medicinální aplikace.

Tato stanice je navržena pro provoz při maximálním tlaku 200 bar**.

Poznámka: Oxid dusný a Oxid uhličitý jsou kapalné plyny. Tyto plyny se při expanzi extrémně

ochlazují a mohou způsobovat zamrzání redukčního ventilu. Je nutno instalovat ohřívače na

obě strany medicinální redukční stanice (celkem 2 ohřívače na redukční stanici).

Před použitím čtěte návod k použití. Vždy tyto instrukce dodržujte!

Zařízení může být použito pouze pro účel stanovený v tomto návodu k použití!

Zařízení musí být instalováno kvaliﬁkovanou osobou a v souladu s požadavky normy ENISO

7396-1 v posledním znění!

Pro zajištění bezpečnosti pacienta, před použitím zkontrolujte zařízení a příslušenství, zda

jeho data a speciﬁkace odpovídá určenému účelu použití.

Zařízení nesmí být za žádných okolností modiﬁkováno jinou osobou než výrobcem!

Zařízení nesmí být použito pro jiný plyn, než který určený štítkem.

Obrázky v tomto návodu k použití jsou pouze informativní. Skutečný produkt se může lišit dle

dané varianty produktu a / nebo nemusí obsahovat všechny části popsané níže. Vždy čtěte

přílohu č. 1 - technická data.

* Redukční stanice musí být instalována v místnosti s minimální teplotou 10°C.

** Maximální provozní tlak je 200 bar myšleno pro použití s lahvemi naplněnými na maximální

ustálený tlak 200 bar (při 15 °C). Při vyšších teplotách lahvový tlak přesáhne hodnotu 200 bar.

Například lahvový tlak Kyslíku při teplotě 50 °C je 240 bar. Tlak vyznačený na štítcích redukčních

ventilů i redukčních stanicích značí maximální ustálený tlak v lahvích, nikoliv vyvíjený tlak v

lahvích, toto by mělo být shodné s maximálním tlakem označeným na lahvích

ČESKY

NÁVOD K POUŽITÍ: MM40  HP UNIT

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3. BEZPEČNOSTNÍ POŽADAVKY NA PROVOZ, PŘEPRAVU

A SKLADOVÁNÍ

UDRŽUJTE VÝROBEK A JEHO PŘÍSLUŠENSTVÍ MIMO:

• zdroje tepla (oheň, cigarety,...),

• hořlavé materiály,

• oleje a mastnotu (pozor při používání krémů na ruce),

• vody,

• prachu.

Výrobek a jeho příslušenství musí být zajištěny proti pádu.

Vždy dodržujte normy pro čistotu kyslíku.

Výrobek a jeho příslušenství se smí používat pouze v dobře odvětraných prostorech.

Před prvním použitím by měl být produkt ponechán v originálním balení. GCE doporučuje použít

originální obal, pokud je produkt vyřazen z provozu (přeprava, skladování).

Poskytovatel produktu musí zajistit, aby během životního cyklu, transportní a skladovací

podmínky byly v souladu s níže zmíněnými “bezpečnostními předpisy” tak, aby byla zachována

jeho funkčnost a čistota. Je nutné dodržovat lokální právní předpisy, pravidla a předpisy pro

medicinální plyny, pro prevenci nehod a ochranu životního prostředí.

PROVOZNÍ PODMÍNKY SKLADOVACÍ A PŘEPRAVNÍ

PODMÍNKY

MIN MAX MIN MAX

*+10 °C +60°C -30 °C +70 °C

10 % 100% 20 % 70 %

600 mbar 1200 mbar 600 mbar 1200 mbar

Zajistěte stanici proti použití nekompetentí osobou!

3.1. PROVOZNÍ BEZPEČNOST

Stanice popsaná níže v tomto návodu je určena pro použití s tlakovými lahvemi a následující

všeobecné postupy obsahují naše doporučení pro bezpečné a efektivní skladování a použití

stlačených plynů.

3.1.1. SKLADOVÁNÍ TLAKOVÝCH LAHVÍ

Sklad tlakových lahví musí být navržen v souladu s platnou normou, níže naleznete několik

doporučení:

• dobře odvětraný prostor chráněný proti venkovnímu počasí.

• Zajistěte prostor proti nebezpečí požáru. Udržujte mimo tepelné a zápalné zdroje. Označte

prostory značením pro “Zákaz kouření”.

• Viditelně označte jako sklad plynu vhodným bezpečnostním značením (např. hořlaviny,

toxické materiály, atd.)

• Udržujte v čistotě a zajistěte vstup pouze autorizovaným osobám.

• Zajistěte prostory vhodným bezpečnostním zařízením (např. hasicí přístroj, dýchací přístroje,

apod.)

Tlakové lahve (ve skladu) by měly být:

• umístěny ve vzpřímené pozici na místě k tomu určenému,

• zabezpečeny proti převrácení,

• opatřeny ochrannými krytkami ventilů (např. krytky, víka, atd.), kde jsou součástí dodávky,

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• rozděleny ve skladovacím prostoru dle různých typů (např. hořlavé, oxidační, atd.)

• rozděleny v prostoru dle množství obsahu a jasně označeny jako plné nebo prázdné,

• skladovány systémem FIFO (nejstarší zboží se vyskladňuje jako první),

• kontrolovány periodicky (obecný stav).

Obsluha: (kdo vstupuje do skladu) by měla být:

• zodpovědná a kompetentní k údržbě skladu plynových lahví a jejich obsah dle doporučení

výše.

• obeznámena a schopná identiﬁkovat obsahy plynových lahví a svazků a potencionální

nebezpečí dané jejich obsahem.

3.1.2. POHOTOVOSTNÍ POSTUPY:

Stav pohotovosti je důsledkem:

• ohně v rozvodové místnosti nebo v její blízkosti,

• nezamýšleného úniku plynu z lahve nebo potrubí,

• další potencionální nebo aktuální poruchy, která má důsledek na celistvost instalace tlakové

stanice.

Postupujte následovně:

• Spusťte signalizační zařízení a informujte správce a/nebo volejte hasiče.

• Evakuujte všechny osoby z nebezpečného prostoru.

V případě požáru přesuňte plynové lahve:

• zavřete uzavírací ventily na všech lahvích a svazcích,

• zavřete izolační ventily,

• odpojte vysokotlaké hadice,

• přesuňte lahve na bezpečné místo pomocí vhodného vozíku na lahve.

V případě nekontrolovaného úniku plynu:

• otevřete dveře distribuční místnosti pro odvětrání prostor,

• nepoužívete zápalné zdroje v těchto prostorech.

Je důležité zajistit neustálý přístup k tomuto návodu k použití a ubezpečit se, že obsluha je

plně obeznámena s funkcemi, ovládáním a bezpečnostními předpisy před samotnou manipu-

lací se stanicí.

Je povinností všech zaměstnavatelů poskytnout takové informace, školení a dozor, které jsou

v souladu s místními předpisy a zajišťují také maximální možnou ochranu zdraví a bezpečnosti

zaměstnanců při práci.

4. INSTRUKTÁŽ PRACOVNÍKŮ

Dle medicinální direktivy 93/42/EHS má poskytovatel zařízení povinnost poskytnout všem

uživatelům a osobám manipulujícím s výrobkem návod k použití & technickou dokumentaci pro

daný produkt.

Nepoužívejte produkt bez řádného seznámení s výrobkem a jeho bezpečného provozu, jak

je deﬁnováno v tomto návodu k použití. Zajistěte, aby si uživatel byl vědom konkrétních infor-

mací a znalostí požadovaných pro používaný plyn.

5. POPIS PRODUKTU

Rozvodové zařízení plynu popsané v tomto návodu k použití je navrženo tak, že připojením

stejného množství lahví na každou stranu zařízení vznikne provozní a rezervní strana dodávky

plynu. Provozní strana zařízení dodává plyn k regulátoru, dokud se lahve nevyprázdní. V té chvíli

se dodávka plynu přepne na rezervní stranu a prázdná strana může být vyměněna. Zařízení je

navrženo tak, aby poskytovalo nepřetržitou dodávku plynu.

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5.1. VYSOKOTLAKÁ ČÁST ZAŘÍZENÍ

I1, I2  VSTUPNÍ PŘIPOJENÍ

Stanice obsahuje levé a pravé závitové vstupní připojení, které je vhodné pro vysokotlaké

hadice.

F1, F2  FILTRY

Stanice obsahuje dva vysokotlaké ﬁltry s nainstalovanými zpětnými vetily, které jsou instalovány

u vstupu rozvodné jednotky. Tyto ﬁltry jsou snadno udržovatelné.

V1, V2  VSTUPNÍ UZAVÍRACÍ VENTILY

Stanice obsahuje dva vstupní uzavírací ventily, které jsou určeny k zavírání a otevírání proudu

vysokého tlaku plynu na levé a pravé straně rozvodové stanice. Těmito dvěma uzavíracími

ventily může být uzavřena distribuce plynu do nemocničního potrubí

V3, V4  ODVZDUŠŇOVACÍ VENTILY

Stanice obsahuje dva odvzdušňovací ventily. Odvzdušňovacími ventily je odpouštěn

tlak v prázdné straně sběrného potrubí před odmontováním vysokotlakých hadic z lahví.

Odvzdušňovací ventily jsou také použity pro čištění sběrného potrubí před otevřením vstupního

uzavíracího ventilu a vpuštěním plynu do hlavního potrubí. Výstup odvzdušňovacího ventilu má

závitový spoj.

R1, R2  REGULÁTORY

Zařízení obsahuje dva vysokotlaké rozvodové regulátory. Regulátory slouží ke snížení vysokého

vstupního tlaku plynu na požadovaný výstupní tlak plynu rozvodné stanice. Informace o

nastavení naleznete v testovacím záznamu přiloženém k produktu.

O1

T3, T4

S1, S2

V5

R1

T1

M1

V3 V1

M3 V6

R2

M2

T2

V2 V4

T5

L

T6

P1, P2

F1

I1

E1

V10

F2

I2

Obr. 1

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GCE MM40 Istruzioni per l'uso

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