GCE MC25 Bruksanvisningar

INSTRUCTION FOR USE

ANVÄNDARANVISNING

KÄYTTÖOHJEET

GEBRUIKSAANWIJZING

BEDIENUNGSANLEITUNG

NÁVOD K POUŽITÍ

HASZNÁLATI ÚTMUTATÓ

NAPUTAK ZA UPORABU

GCE HEALTHCARE

CENTRAL GAS SUPPLY SYSTEM

CENTRALGASANLÄGGNING

EN

SV

MC25

KAASUN KESKUSSYÖTTÖJÄRJESTELMÄ

CENTRAAL GASTOEVOERSYSTEEM

FI

NL

ZENTRALES GASVERSORGUNGSSYSTEM DE

REDUKČNÍ STANICE CS

HU

KÖZPONTI GÁZELOSZTÁS

HR

REDUKCIJSKA STANICA

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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 classiﬁ ed 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 and EN 60601-1 standards.

2. INTENDED USE

The MC25 semiautomatic medical manifold is intended for use in hospital pipeline system as

medical gas source. Together with MC25 shall always be used alarm providing all alarms ac-

cording to standard EN ISO 7396-1.

This instruction for use details the operational and safety procedures for the MC25 manifold.

The MC25 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 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.

* Manifold shall be installed in room with minimal temperature of 10 °C.

** Maximum service pressure of 200 bar means for use with cylinders ﬁ lled 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 cyl-

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

the cylinder.

ENGLISH

INSTRUCTION FOR USE: MC25

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3. OPERATIONAL, TRANSPORT AND STORAGE SAFETY RE

QUIREMENTS

KEEP THE PRODUCT AND ITS ASSOCIATED EQUIPMENT AWAY FROM:

• heat sources (ﬁ re, cigarettes, ...)

• ﬂ ammable 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 require-

ments, 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 qualiﬁ ed 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, eﬃ 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 ﬁ re 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. ﬂ ammable,

toxic, etc.).

• Kept clear with access restricted to authorised personnel.

• Provided with appropriate safety/emergency equipment (e.g. Fire extinguisher, breathing

apparatus etc.)

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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. ﬂ ammable, 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 ﬁ rst.

• 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 ﬁ re 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 aﬀ ect the integrity of the manifold installation.

Procedure to follow:

• Raise the alarm and notify a supervisor and/or call the ﬁ re brigade.

• Evacuate all personnel from the immediate danger area.

In case of ﬁ re, 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 deﬁ ned in this Instruction for use. Ensure user is aware of particular information and knowl-

edge required for the gas in use.

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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.

V4

M3

R3

S3

M1

S1

R1

V1 I1 F1 L1 F2 I2 V2

R2

S2

M2

S4

R4

M4

O1 V9

T7

T3

T4

T5

T6

V3

V7 V5

M5

T1

M6

T2

V6 V8

E1

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I1, I2  INLET CONNECTIONS

The inlet connections for left and right side collection pipe, has inlet threads that ﬁ ts to the high

pressure hoses.

F1, F2  FILTERS

The manifold contains two 100 microns high pressure ﬁ lters which are installed on the inlet of

the manifold. These ﬁ lters can easily be maintained.

V1, V2  INLET SHUT OFF VALVES

The manifold contains two inlet shut oﬀ valves which are for opening and closing main high

pressure supply from the gas cylinders, to the left and right side of the manifold.

V3  SHUT OFF VALVE

The manifold contains one shut oﬀ valve which is used during service and repair. With this valve

together with V4 it is possible to isolate one side from the other.

V4  SWITCH VALVE

The manifold contains one 3-way switch valve which is switching the gas ﬂ ow between regula-

tor R3 and R4.

V5, V6  INLET SHUT OFF VALVES ON COLLECTING PIPES

The manifold contains inlet shut oﬀ valves on collecting pipes including non return valves. The

shut oﬀ valves stop the gas supply between each cylinder and collecting pipe.

V7, V8  PURGE SHUT OFF VALVES ON COLLECTING PIPE

The manifold contains two purge valves. Through the purge valves it is possible to ventilate

high pressure collecting pipe and hoses on the empty side before removing the high pressure

hoses from the cylinders. The purge valve are also used for cleaning collecting pipes before

opening the inlet shut oﬀ valve and supplying gas to the manifold.

V9  OUTLET SHUT OFF VALVES

The manifold contains outlet shut oﬀ valve which is used for opening and closing gas supply to

the hospital pipeline system.

R1, R2  HIGH PRESSURE REGULATORS

The manifold contains two high pressure regulators. The regulators are reducing the pressure

from high pressure to the intermediate pressure.

R3, R4  LINE REGULATORS

The manifold contains two line pressure regulators. The regulators are reducing the pressure

from intermediate pressure to the distribution pressure. Information about setting of product

you can ﬁ nd in testing report included in delivery of the product.

S1, S2  SAFETY VALVES

The manifold contains two intermediate pressure safety valves, one on each side. When the

pressure increases up to preset limit, the safety valve will activate and gas will purge out

through the exhaust pipe.

S3, S4  SAFETY VALVES

The manifold contains two distribution pressure safety valves, one on each side. When the

pressure increases up to preset limit the safety valve will activate and gas will purge out through

the exhaust pipe.

M1, M2  INTERMEDIATE PRESSURE GAUGES

The manifold contains two intermediate pressure gauges. The gauges are showing the pres-

sure after the ﬁ rst stage regulators.

M3, M4  LOW PRESSURE GAUGES

The manifold contains two low pressure gauges. The gauges are showing the distribution pres-

sure.

M5, M6  HIGH PRESSURE GAUGES

The manifold contains two high pressure gauges. The gauges are showing the pressure in the

gas cylinders/cylinder bundles.

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T1, T2  HIGH PRESSURE SENSORS

High pressure sensors are installed on the collecting pipes. Main function of the high pressure

sensors are to supervise leakage on reserve side and send information to the alarm. When

leakage on reserve side is detected by pressure drop, the alarm sounds is to inform the techni-

cal personal.

T3  PRESSURE SENSOR

The pressure sensor is supervising the operating side and sending a signal to the alarm unit,

when the manifold starts to supply from reserve side.

T4, T5  PRESSURE SENSORS IN OUTLET BLOCK

The pressure sensors are installed in the outlet block. Main function of pressure sensors is to

supervise correct distribution pressure. If pressure is too low the sensor T4 will send a signal to

the alarm unit. If the pressure is too high sensor T5 will send a signal to the alarm.

T6  PRESSURE SENSOR

The pressure sensor is supervising intermediate pressure. Main function of the pressure sensor

is to supervise the upper limit of intermediate pressure. If the pressure is too high, the sensor

will send information to the alarm unit.

T7  MICRO SWITCH

The manifold contains one micro switch which indicates the position of lever L1.

L1  LEVER

The position of the lever decides which side is operating side and which side is reserve side.

When the manual lever is in upper position, left side is in operation and right side is reserve

side. When the lever is in lower position right side is in operation and left side is reserve side.

E1  EVACUATION PIPE

The evacuation pipe is exhaust pipeline from all safety valves.

O1  OUTLET

The manifold contains one outlet pipe.

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 fulﬁ lled.

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.

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6.1.WALL FIXING

Positioning of the manifold, please consult with gas supplier and designer. Mount the manifold

at the height to suit either cylinders or cylinder bundles.

The holes to use for mounting the manifold are shown below.

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 AND PURGE OUTLETS

Fittings for safety valves and purge valves outlet pipes are quick connection with O-rings, pipe

diameter 15 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 building.

6.4.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 shutoﬀ valves

V7, (V1 & V2) and the purge valves (V7 & V8) are in the closed position.

• Open one cylinder from one bank SLOWLY.

• Check connection between tailpipe and inlet connection for leakage using a 0.5% teepol /

water solution.

• 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 con-

nection check to see if sealing washer is ﬁ tted correctly or missing. If it is damaged change

the sealing and try again.

6.5.FITTING TO SOURCE OF ELECTRICITY

Fitting must be carried out by a trained person with an appropriate licence according to national

standards.

Act upon instruction for use of gas alarm.

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7. OPERATION AND BANK CHANGE OVER

The text below depicts the controls for normal operation of the MC25 manifold.

V4

M3

R3

S3

M1

S1

R1

V1 I1 F1 L1 F2 I2 V2

R2

S2

M2

S4

R4

M4

O1 V9

T7

T3

T4

T5

T6

V3

V7 V5

M5

T1

M6

T2

V6 V8

E1

7.1.START UP OF MANIFOLD

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

• Check both shut oﬀ valves V1 & V2 are closed.

• Check both shut oﬀ valves V5 & V6 are closed.

• Check both purge valves V7 & V8 are closed.

• Check that the valves V3 & V9 are in open position.

• Check that the valves V4 is in left or right position.

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• Open the cylinder valves, open valves V5 & V6 and than valves V1 & V2 slowly, and the gas

supply will start through the outlet connection O1. The cylinder pressures can be read on the

gauges M5 & M6, the intermediate pressure on M1 & M2 and the distribution (outlet) pressure

on gauge M3 & M4.

• Decide by moving the lever L1, if right or left bank of cylinders should start to supply. Always

start supply from the bank that has the lowest pressure.

• Check if lever is in correct position. Correct position is extreme upper or bottom position.

Correct lever position can be checked only by operator. Micro switch indicates only bottom

or upper position of lever.

• Check all connections for leakage using a 0.5% teepol / water solution.

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

inlet gauges M5 or M6.

Info: One micro switch T7 is ﬁ tted to the back plate to electrically decide which side is moni-

tored for leaking reserve.

7.2.BANK CHANGE OVER

At a pre-determined pressure set of the manifold regulators of 11,5 bar, the reserve bank will

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

side” at inlet pressure lower then 10,3 bar. It is indicated by pressure switches. (See Chapter

8 – Alarm conditions).

7.2.1. LEFT HAND LH SIDE EMPTY

• The inlet pressure gauge M5 on the left-hand side is indicating exhausted cylinders, so the

left-hand bank of cylinders needs to be replaced.

• Close shut-oﬀ valve V1 and the isolating valves on the empty cylinders or cylinder bundles.

• Open purge valve V7 to vent any excess gas within the high pressure hose.

• Close purge valve V7 and disconnect high pressure hose from cylinders or cylinder bundles.

• 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).

• Open cylinder valves slowly and leak test joints with 0.5% teepol in water solution.

• Open shut-oﬀ valve V1 and read the full content of the new cylinders on the inlet gauge M5.

• Change the position of the lever L1, to give normal operation to right-hand side (lever is in

extreme bottom position), and change the position of valve handle V4 (shall point to the right).

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 M6 on the right-hand side is indicating exhausted cylinders, so the

right-hand bank of cylinders needs to be replaced.

• Close shut-oﬀ valve V2 and the isolating valves on the empty cylinders or cylinder bundles.

• Open purge valve V8 to vent any excess gas within the high pressure hose.

• Close purge valve V8 and disconnect high pressure hose from cylinders or cylinder bundles.

• 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).

• Open cylinder valves slowly and leak test joints with 0.5% teepol in water solution.

• Open shut-oﬀ valve V2 and read the full content of the new cylinders on the inlet gauge M6.

• Change the position of the lever L1, to give normal operation to left-hand side (lever is extreme

upper position), and change the position of valve handle V4 (shall point to the left). 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

For short term (hours) shutdown close shut-oﬀ valves V1 & V2 and/or V5 & V6 and/or V9.

For long term (days) shutdown close shut-oﬀ valves V1 & V2 and/or V5 & V6 and the cylinder

isolating valves.

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8. ALARM CONDITIONS

8.1.ALARM PROCEDURE

On signal of alarm condition the appropriate visual indicator is illuminated on the Gas alarm

unit. The alarm condition, should be recorded and the necessary action taken, as detailed in

the sections below.

8.2.STATUS INDICATED BY ALARM

8.2.1.LEAKING RESERVE SIDE

The alarm starts in following situations:

Reserve side pressure is too low or lever L1 is not in correct position

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

change component or gasket. Check if the lever L1 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:

Supplying side is empty

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

• Switch lever L1 to opposite position.

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

8.2.3.HIGH INTERMEDIATE PRESSURE

The alarm starts in following situations:

Intermediate pressure is too high

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

regulators by closing valve V3 and check one regulator at a time. Be sure that the valve V4

is set to the same operation side as lever L1. 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 to replace the regulator with a

new or refurbished unit.

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

8.2.4.HIGH DISTRIBUTION PRESSURE

The alarm starts in following situations:

Distribution pressure is too high

• Check that the distribution pressure is as preferred. If not, isolate the regulators R3 & R4 by

closing valve V3 and check one regulator at a time. Be sure that the valve V4 is set to the

same operation side as lever L1. Start with the regulator on reserve side, relief the pressure

by the safety valve S3 & S4 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 to replace the regulator with a

new or refurbished unit.

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

8.2.5.LOW DISTRIBUTION PRESSURE

The alarm starts in following situations:

Distribution pressure is too low

• Check the high pressure gauges M5 & M6, if the valves V5 & V6 and cylinders valves are

open, if the cylinders are not empty or if there is not a leakage. In this case replace cylinders

or make corrections on collection pipelines.

• Check the intermediate pressure gauges M1 & M2, if the valves V1 & V2 and V3 valves are

open or if there is not a leakage. In this case follow procedure as Intermediate pressure is

too high.

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• Check the distribution pressure gauges M3 & M4, if the valve V4 is in correct position or if

there is not a leakage. In this case reset regulators R3 & R4 one at a time by releasing the

pressure with the safety valves S3 & S4, start with the reserve side. Check if the pressure

comes back to normal, if not increase the distribution pressure by turning the regulator R3 &

R4 screw and check again. If the distribution pressure is still low, contact authorised service to

replace the regulator with a new or refurbished unit.

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

9. ROUTINE MAINTENANCE INSTRUCTION

Service shall be carried out only by authorised person according to national standards.

Use only original components. Contact GCE for spare parts lists and further information about

repair procedures.

9.1.THE FOLLOWING ROUTINE CHECKS SHOULD BE MADE WHEN

CHANGING EMPTY CYLINDERS:

• Check all valves for correct operation and leak test using a 0.5% teepol in water solution.

• Check pipe work for leaks using a 0.5% teepol in water solution.

• 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

aﬀ ect the continuing safe operation of the manifold.

9.1.1.GENERAL MAINTENANCE SHOULD BE UNDERTAKEN IN ACCORDANCE

WITH A PLANNED MAINTENANCE SCHEDULE, WHICH SHOULD INCLUDE THE

FOLLOWING ITEMS:

• Leak test all joints using a 0.5% teepol in water solution.

• Examine mounting frames and cylinder securing chains for damage deterioration and security

of attachment.

• Examine tailpipes/high pressure hoses for damage and security of attachment.

• 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.

• No item of equipment is overdue for any periodic inspection/test which may be applicable.

• The setting and operation of regulators is satisfactory.

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

show signs of deterioration or unauthorised interference.

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

• Check that connecting nuts and seating faces are undamaged.

• Check gauges operate smoothly and zero correctly.

• Check that isolating valves for closure tightness is indicated 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.

• Check that all ventilation grills are free from obstruction and that the extraction system (when

installed) is functioning correctly.

• Ensure that all restrictions on smoking and open ﬁ re are strictly enforced.

• 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 eﬀ ectively.

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9.1.2.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 aﬀ 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.

10. SCHEME OF EXAMINATION

GCE recommendations for a Written Scheme of Examination:

EQUIPMENT EXAMINATION

INTERVAL GUIDELINES OF WRITTEN SCHEME

1. High pressure

hoses

Examine when

changing

cylinders.

a. Replace with new hose, every 5 years.

b. Replace gaskets when changing

cylinders.

c. Record replacement.

2. Safety Relief Valve 1 year a. Visual, external examination.

b. Check the functions.

c. Record all details of examination.

3. Regulator 1 year a. Replace with new or manufacturer’s

refurbished unit.

b. Check the functions.

c. Record all details.

4. Non return valves 1 year a. Function and Filter testing.

b. Replace seals/glands/o-rings, if

needed.

c. Leakage test.

d. Record all details of examination.

5. Valves 1 year a. Functional test

c. Record all details of examination.

6. Manifold 1 year a. Visual, external examination.

b. Leakage test.

c. Record all details of examination.

7. Filters 1 year a. Replace with new or manufacturer’s

refurbished unit.

b. Leakage test.

c. Record all details.

11. WIRING

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

cence according to national standards.

12. ACCESSORIES

Contact supplier of the system or GCE dealer for accessories lists. Use only original GCE parts.

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13. 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.

14. DISPOSAL

14.1.LIFE TIME

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 MC25 must be withdrawn from service.

To prevent reuse, the owner shall make the MC25 impossible to use, or contact GCE (or GCE

authorised customer or third party) for return of the product. The provider of the device shall

prevent the reuse of the product and handle the product in compliance with “Directive of Euro-

pean Parliament and Council 2008/98/EC on waste“.

14.2.MANUFACTURING DATE

The manufacturing date is included in MC25 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 ﬀ .

14.3.RECYCLING

The product shall be recycled according to local regulations.

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.

14.4.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.

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. 231-100-4, 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 eﬃ cient material handling with minimal impact to

environment and health.

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

concentrations exceeding 0.1% are included in any GCE product.

16/123

EN

APPENDIX:

Nr. 1 - Technical speciﬁ cation and performance data

Nr. 2 - Testing protocol

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.

15. GLOSSARY

Consult instruction for use

Take back equipment for

recycling. Do not dispose

equipment into unsorted

municipal waste

Caution! Ambient pressure limit

Keep away from heat and

ﬂ ammable materials. Suitable for Hospital care use

Keep away from oil and

grease! Weight of product

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

16. 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.

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SV

1. FÖRORD

Denna användaranvisning tillhandahåller nödvändig information som omfattar produktens to-

tala livscykel:

• Installation,

• Handhavande och byte av gascylindrar,

• Larm tillstånd,

• Underhåll och rengöring,

• Deponering.

Centralgassystemen från GCE är medicinsktekniska produkter klassiﬁ cerade i klass IIb enl. rå-

dets direktiv 93/42/EEG om medicinsktekniska produkter.

Uppfyllandet av kraven i rådets direktiv 93/42/EEG om medicinsktekniska produkter baseras på

tillverkningsnormerna EN ISO 7396 1 och EN 60601 1.

2. AVSEDD ANVÄNDNING

MC25 är en halvautomatisk medicinsk gascentral avsedd att användas i sjukhusets rörledn-

ingssystem som försörjningsenhet av medicinska gaser. MC25 skall alltid övervakas av gaslarm

enligt standard EN ISO7396-1.

Dessa instruktioner innehåller detaljerade handhavande och säkerhets anvisningar för gascen-

tral MC25. MC25 ﬁ nns för Oxygen, Lustgas N2O, A-luft, Instrumentluft, och kan även användas

till Koldioxid CO2, Nitrogen och gasblandningar för medicinska applikationer. Dessa gascen-

traler är designade för ett maximalt inloppstryck på 200 bar.**

Anmärkning: Lustgas och koldioxid är kondenserade gaser. Dessa gaser kyls ned extremt

vid expansion och kan medföra tillfrysning av reduceringsventilen. Värmare kan installeras

på den medicinsktekniska reduceringsenhetens båda sidor (totalt två värmare per reduce-

ringsenhet).

Läs denna instruktion före användning av produkten. Följ alltid instruktionerna!

Produkten skall endast användas för det ändamål som beskrivs i denna instruktion!

Produkten måste installeras av en kvaliﬁ cerad person och genom överensstämmelse av alla

krav enligt EN ISO 7396-1 i dess ändrade lydelse.

För att garantera säkerheten för patienten, kontrollera utrustningen och tillbehör som an-

vänds med produkten före användning. Kolla så att data och prestanda överensstämmer med

den avsedda användningen av produkten!

Produkten får inte under några omständigheter modiﬁ eras av annan än tillverkaren!

Produkten får inte användas för annan gas än vad som anges på etiketten.

Bilderna i denna anvisning är endast av informativ karaktär. Den verkliga produkten kan skilja

sig från den avbildade beroende på produktvariant och/eller behöver inte nödvändigtvis in-

nehålla samtliga de detaljer som beskrivs nedan. Läs alltid igenom bilaga nr. 1 - tekniska data.

* Reduceringsenheten skall alltid installeras i utrymmen som har en lägsta temperatur om 10°C.

** Maximalt inloppstryck om 200 bar avser nominellt tryck vid användning av gasﬂ askor fyllda

till ett maximalt tryck om 200 bar (vid 15 °C). Vid högre temperaturer överstiger ﬂ asktrycket 200

bar. Som exempel är trycket hos syrgas 240 bar vid en temperatur om 50 °C.

Det tryck som anges på märkningar hos reduceringsventiler och reduceringsenheter avser

maximalt nominellt ﬂ asktryck, inte det tryck som utvecklas i ﬂ askorna, vilket skall vara lika med

det maximala tryck som gasﬂ askorna är märkta med..

SVENSKA

ANVÄNDARANVISNING: MC25

P1 V3 M3 T5 V6 E1 P3

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SV

3. SÄKERHETSKRAV VID DRIFT, TRANSPORT OCH FÖRVA

RING

Håll produkten, inkl. tillbehör, bortom påverkan från

• värmekällor (eld, cigaretter, etc.),

• brännbara material,

• olja eller fett,

• vatten,

• damm.

Produkten, inkl. tillbehör, måste vara skyddad mot omkullvältning.

Följ alltid renlighetsföreskrifter för syrgas.

Använd endast produkten, inkl. tillbehör, i väl ventilerade utrymmen.

Före första användning skall produkten behållas i sitt originalemballage. I det fall den tas ur drift

(för transport, eller förvaring), rekommenderar GCE att originalemballaget används (inkl. inre

utfyllnadsmaterial).

Ägaren eller användaren av produkten skall försäkra att under produktens livscykel är

miljöförhållanden under transport och lagring enligt ovan kapitel ”Säkerhetsanvisningar” sek-

tion för anvisningar, om produktens integritet och renhet.

Nationella lagar, kungörelser och föreskrifter för medicinska gaser, arbetarskydd och miljö skall

följas.

DRIFT FÖRUTSÄTTNINGAR LAGRING OCH TRANSPORT

MIN MAX MIN MAX

+10 °C +60 °C -30 °C +70 °C

10 % 100 % 20 % 70 %

600 mbar 1200 mbar 600 mbar 1200 mbar

Det är mycket viktigt att säkerställa att endast kvaliﬁ cerade personer har tillgång till enheten

- möjlighet för felanvändning.

3.1.DRIFTSSÄKERHET

Den gascentral som beskrivs nedan i denna anvisning, är avsedd för användning med tryck-

ﬂ askor och nedanstående allmänna åtgärder innehåller våra rekommendationer för säker och

eﬀ ektiv förvaring och användning av komprimerade gaser.

3.1.1.FÖRVARING AV TRYCKFLASKOR

Förvaringsutrymmet för tryckﬂ askor skall vara konstruerat i enlighet med gällande normer.

Nedan ﬁ nns ett antal rekommendationer:

• välventilerat utrymme som skyddas mot väder och vind.

• Utrymmet skall vara brandskyddat. Se till att hålla utrymmet bortom värmekällor och öppen

eld. Märk utrymmet med ”Rökning förbjuden”.

• Märk gasförrådet med lämplig varningsmarkering (ex.vis brandfara, gift, etc.)

• Håll utrymmet rent och se till att endast behörig personal har tillträde.

• Se till att lämpliga skyddshjälpmedel (ex.vis brandsläckare, andningsutrustning, o.dyl.) ﬁ nns

till hands

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Tryckﬂ askor (i förvaringsutrymmet) skall:

• stå i upprätt läge på plats som är avsedd för dessa,

• vara säkrade mot vältning,

• vara försedda med skydd för ventiler (ex.vis kåpor, lock, o.s.v.), om detta ingår i leveransen,

• vara uppdelade enl. typ (ex.vis brandfarliga, oxiderande, o.s.v.) i förvaringsutrymmet,

• placeras i utrymmet beroende på innehållsmängd och klart märkas som fulla eller tomma,

• förvaras enl. FIFO-metoden (de äldsta varorna tas ut ur lagret som först)

• kontrolleras regelbundet (allmänt skick).

Operatör: (den som träder in i förvaringsutrymmet) skall vara:

• ansvarig för och behörig att underhålla förvar av gasﬂ askor och innehållet i dessa enl.

ovanstående rekommendationer.

• ha kännedom om och förmåga att identiﬁ era gasﬂ askor och ﬂ askgrupper och ev. faror som

kan uppstå p.g.a innehållet.

3.1.2.ÅTGÄRDER VID NÖDSITUATIONER:

Nödsituationer uppstår vid:

• brand i gascentralens utrymme eller i dess närhet,

• oavsiktligt utsläpp av gas från ﬂ askor eller rörledning,

• andra potentiella eller aktuella fel, som påverkar funktionen hos gascentralens installation.

Gå tillväga på följande sätt:

• Larma och informera driftsansvarig och/eller kalla på räddningstjänsten.

• Evakuera alla personer från riskområdet.

Flytta gasﬂ askor vid brand:

• stäng avstängningsventilerna på alla ﬂ askor och ﬂ askgrupper,

• stäng isolerings ventiler på samlingsrören,

• koppla från högtrycksslangar,

• ﬂ ytta ﬂ askorna till säker plats med gasﬂ askkärra.

Vid okontrollerad utströmning av gas:

• öppna dörren till gascentralens utrymme för att vädra ut gasen,

• använd inte antändningskällor i dessa utrymmen.

Det är viktigt att denna anvisning ständigt ﬁ nns tillgänglig och att man ser till att personalen

har full kännedom om funktioner, handhavande och säkerhetsföreskrifter före all hantering

av centralen.

Arbetsgivaren är skyldig att tillhandahålla den information, utbildning och uppsikt som öve-

rensstämmer med lokala föreskrifter och samtidigt säkerställa maximalt arbetarskydd och

säkerhet för personalen vid arbetets utförande.

4. INSTRUKTION AV PERSONAL

EU-direktivet 93/42/EEG om medicintekniska produkter föreskriver, att den som levererar

produkten, skall se till att all personal som hanterar produkten, har tillgång till bruksanvisning

och information om tekniska data.

Använd inte produkten utan att ordentligt känna produkten och hur den används på ett säkert

sätt enligt Bruksanvisningen. Se till att användaren har kännedom om speciﬁ k information

och kunskaper gällande den gas som används.

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5. PRODUKTBESKRIVNING

Gascentralerna som beskrivs i denna instruktion är designade för att ansluta samma antal gas-

ﬂ askor på båda sidor, en för driftsida och en för reservsida. Centralen kommer att leverera gas

från driftsidans ﬂ askpaket till regulatorerna tills ﬂ askorna är tomma och trycket sjunker till ett

förinställt värde. Då kommer gas försörjningen att växla över till reservsidan och de tomma

ﬂ askorna kan bytas ut. Syftet är att ge en avbrottsfri gasförsörjning.

V4

M3

R3

S3

M1

S1

R1

V1 I1 F1 L1 F2 I2 V2

R2

S2

M2

S4

R4

M4

O1 V9

T7

T3

T4

T5

T6

V3

V7 V5

M5

T1

M6

T2

V6 V8

E1

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