GCE druva MC70 Manuale utente

GCE CENTRAL GAS SYSTEMS

TERMINAL UNITS MC70

TERMINAL UNITS,INSTRUCTION FOR USE

GASUTTAG,BRUKSANVISNING

GASSUTTAK,BRUKSANVISNING

GASUDTAG,BRUGERVEJLEDNING

PÄÄTEYKSIKÖT,KÄYTTÖOHJE

PUNKTY POBORU GAZU,INSTRUKCJA OBSŁUGI

TOMADA, INSTRUÇÕES DE UTILIZAÇÃO

TOMA DE GASES MEDICINALES,INSTRUCCIONES DE USO

2/96

1. FOREWORD

GCE Terminal units (“TU”) are medical devices classiﬁed as Class IIb ac-

cording to the Directive concerning medical devices

(93/42/EEC – MDD2007/47/EC).

Conformity with essential requirements of the Directive 93/42/EEC –

MDD2007/47/EC is on the basis of the EN ISO 9170-1 standard.

2. INTENDED USE

TU are intended to be used as outlet points at hospital low pressure gas

supply system. TU is an outlet point where operators connect and dis-

connect an inlet of other gas speciﬁed medical devices, such as medical

hoses, ﬂowmeters,etc.

The TU are designed to be gas speciﬁc which means that they cannot be

connected to a medical device that is for a dierent type of gas.

TU cannot be placed into operation before these instructions are thor-

oughly read and understood.

Operator of TU must be properly trained for such operation - see chapter

BASIC VARIANTS OF TU DIVISION ACCORDING TO THE GAS:

• Oxygen (O2)

• Medical air (AIR)

• Air for running surgical tools (AIR-800)

• Laughing gas (nitrous oxide)

(N2O)

• mixtures of the speciﬁed gases

• Underpressure (Vacuum)

(VAC)

• Nitrogen (N2

• Carbon dioxide (CO2

ENGLISH

INSTRUCTION FOR USE: TU MC70

3/96

3. OPERATIONAL, TRANSPORT AND STORAGE

SAFETY REQUIREMENTS

KEEP THE PRODUCT AND ITS ASSOCIATED EQUIPMENT AWAY FROM:

• All sources of heat

• Flammable materials

• Oil or grease (including all hand creams)

• Water

• Dust.

The product and its associated equipment must be prevented from fall-

ing.

Always maintain oxygen cleanliness standards.

Use only the product and its associated equipment in a well ventilated

area.

OPERATING CONDITIONS STORAGE, TRANSPORT

CONDITIONS

-20/+60 °C -30/+70 °C

10/100% 20/70%

600/1200 mbar 600/1200 mbar

Before ﬁrst use the product must be kept in its original packaging to en-

sure that the product is not contaminated. For transport and storage GCE

recommends use of the original packaging (including internal sealing bag

and caps). Statutory laws, rules and regulations for medical gases, accident

prevention and environmental protection must be observed.

SAFETY OPERATION

TU described in this document must only be used with medical gases

and the procedures for the safe and eective use of these medical com-

pressed gases must be followed at all times.

4. PERSONNEL INSTRUCTIONS AND TRAINING

According to Medical Devices Directive 93/42/EEC the product provider

must ensure that all personnel handling the product are provided with the

operating instructions & performance data and are fully trained to carry out

that operation. Trainees need to be supervised by an experienced person.

Do not use the device without being trained. Training can be only done

by a person with an appropriate education, experience and knowledge

that has been also trained by the manufacturer.

4/96

For further information about training programs, please contact GCE.

5. PRODUCT DESCRIPTION

TU consist of two basic parts:

• housing

• quick connection valve

Individual parts must always be designed as gas speciﬁc. Each of these

basic parts is marked with stamping displaying the gas for which it is in-

tended.

An integral part of each terminal unit is a check valve enabling the through-

pass of the gas when a counterpart is connected and which automatically

prevents the gas from passing through when the counterpart is discon-

nected.

108

Guide slot

6 10 4 3 2 15

1. Locking ring

2. Push button

3. Cover screw

4. Transparent cover plate

5. Name plate

6. Quick connection valve

7. Housing holder

8. Housing

9. Holding screw

10. Connection nut

5/96

6. INSTALLATION

Installation can only be done by a person that has the appropriate certiﬁ-

cates according to the required national standards and laws for mount-

ing and repairs of concerned gas medical devices. Standards valid for

such installations and testing are ENISO7396-1 for medical central gas

systems and ENISO5359 for installations with low pressure hoses. For

more information contact GCE or distributor of GCE products.

For more information contact GCE or distributor of GCE products.

Do not connect the housing to pipeline with dierent type of gas.

During mounting use always appropriate and functional tools and keep

all safety requirements for operation, transport, storage (see chapter 3).

Ensure that all devices, equipment and also hands and work wear are

kept clean and free from oil and grease.

6.1. VISUAL CHECK BEFORE INSTALLATION

• Check that all components in the package (including labels) are not

damaged. If they are damaged, withdraw them from service and label.

• Visually check if the product is clean, if needed follow the procedure for

cleaning that is described in this instruction for use.

6.2. INSTALLATION

• Before assembly please blow through the internal space of the pipeline.

• Check whether the sealing (8) is present before installation of the check

valve subassembly.

• Check whether the unit case is identical with the marking of the gas on

the pipeline.

The minimum inter-axis distance between 2 sockets must be a minimum of

100 mm; the following order should be respected beginning from the left.

10 cm 10 cm 10 cm

1 2 3 4

O2N2O Medical Air Medical aspirator

(vacuum)

6/96

6.2.1. IN THE REAR WALL BEFORE THE FRONT WALL IS MOUN

TED

10815 16 11

17 6 10 5 4 3 2 1

12 13 7 9

Side view

Rear wall Front

wall

View from above

Guide slot

FIRST CHECK THAT THE VALVE BODY IS FOR THE CORRECT TYPE OF

GAS!

The valve is plugged and leakage-tested upon delivery.

• Measure the distance between the walls (a).

• Adjust the mounting brackets (17) to correct measurement (1) (see sketch

above) and tighten by means of the screws (13) and nuts (14) to the wall

box brackets (16)

• Mark out where to place the wall box (11).

• Mount the wall box to the rear wall with two enclosed plaster screws (12).

• Insert the copper pipe on the valve body (8) into the wall box (11) and

through the prebored hole (from the front side of the wall).

• Slip the rubber bushing (15) over the copper pipe and ﬁx it to the wall

box (11).

• Place the valve body (8) in position and fasten it with the two enclosed

hexagonal screws (9) by means of an allen key. Use the protecting cover

until the valve is mounted, so that dust will not contaminate the valve

body.

• Solder the copper pipe to the correct gas pipe (use cadmium-free silver

solder).

• Make a pressure test of the pipe connection.

• Continue the assembly after a hole ca 78 mm is taken up on the correct

place of the front wall and the wall is mounted.

• Unscrew the connecting nut (10) and remove the tightening plug.

7/96

• Mount the quick connection valve (6) after checking that the O ring is

correctly positioned. Tighten by means of the special tool 325 197 290

and check during the tightening that the guide slot is positioned up-

wards, corresponding to 12 on a clock face. (See sketch.)

• Place the correct name plate (5) on the transparent cover plate (4) (the

screw holes shall be in horizontal position) and mount it with the two

screws (3). (Do not use too much force!)

• Fasten the push plate (2) with the circlip (1)

• Test the function of the coupling by connecting a dosage device with a

male coupling. The coupling should only release its grip when the push

plate (2) is pressed inwards.

6.2.2. IN THE FRONT WALL BEFORE THE REAR WALL IS MOUN

TED

10815 16 11 6 10 5 4 3 2 1

12 7 9

Guide slot

Side view

FIRST CHECK THAT THE VALVE BODY IS FOR THE CORRECT TYPE OF

GAS!

The valve is plugged and leakage-tested upon delivery.

• Take up a hole diameter ca 78 mm on the front wall where the outlet valve is

to be placed.

• Put the wall box (11), from the rear side of the front wall, on its place and fas-

ten it by means of the two plaster screws (12). (The mounting brackets with

screws and nuts are not needed when front wall mounting is used.)

• Insert the copper pipe on the valve body (8) into the wall box (11) and through

the prebored hole (from the front side of the wall).

• Slip the rubber bushing (15) over the copper pipe and ﬁ x it to the wall

• box (11).

• Place the valve body (8) in position and fasten it with the two enclosed hex-

agonal screws (9), by means of an allen key. Use the protecting cover until the

valve is mounted, so dust will not contaminate the valve body.

• Solder the copper pipe to the correct gas pipe (use cadmium-free silver sol-

der).

• Make a pressure test of the connection.

8/96

• Unscrew the connecting nut (10) and remove the tightening plug.

• Mount the quick connection valve (6) after checking that the O-ring is correctly

positioned. Tighten by means of the special tool 325 197 290 and check dur-

ing the tightening that the guide slot is positioned upwards, corresponding to

12 on a clock face. (See sketch.)

• Place the correct name plate (5) on the transparent cover plate (4) (the screw

holes shall be in horizontal position) and mount it with the two screws (3). (Do

not use too much force!)

• Fasten the push plate (2) with circlip (1).

• Test the function of the coupling by connecting a dosage device with a male

coupling. The coupling should only release its grip when the push plate (2) is

pressed inwards.

6.2.3. EXPOSED GAS OUTLET MC 70

8 10 6 10 11 45 2 1

127 3

Side view

Guide slot

FIRST CHECK THAT THE VALVE BODY IS FOR THE CORRECT TYPE OF

GAS!

The valve is plugged and leakage-tested upon delivery.

• Mark out where to place the outlet valve.

• Place the valve body (8) in position on the wall and fasten it with the two

enclosed plaster screws (12).

• Solder the copper pipe to the correct gas pipe (use cadmium-free silver sol-

der.)

• Make a pressure test of the pipe connection. Use the protecting cover until

the valve is mounted, so that dust will not contaminate the valve body.

• Unscrew the connecting nut (10) and remove the tightening plug.

• Mount the quick connection valve (6) after checking that the O-ring is correctly

positioned. Tighten by means of the special tool 325 197 290 and check dur-

ing the tightening that the guide slot is positioned upwards, corresponding to

12 on a clock face. (See sketch.)

• Place the correct name plate (5) on the transparent cover plate (4) (the screw

holes shall be in horizontal position) and mount it placed in the wall box (11)

with the two screws (3). (Do not use too much force!)

9/96

• Fasten the push plate (2) with the circlip (1).

• Test the function of the coupling by connecting a dosage device with a male

coupling. The coupling should only release its grip when the push plate (2) is

pressed inwards.

6.3. TEST AFTER THE CARRYING OUT OF INSTALLATION

6.3.1. TEST OF FUNCTIONALITY AND LEAKAGE TEST AFTER THE

END OF INSTALLATION

• For the test of functionality and leakage test use the gas for which the

terminal unit is intended or the medical air or nitrogen with pressure as

speciﬁed in Chapter 2.

• Test the connectivity of counterparts of all installed terminal units, for

variants with the positioning of a counterpart of the quick connector

verify the right orientation of the quick connectors.

• Test the through-pass capacity of the terminal unit for presence of gas

on the outlet.

• Test the general tightness of the terminal unit and with all accessories

in the state with connected as well as disconnected counterparts of the

quick connectors. The leakage must not exceed 0.296 ml/min in any of

the described conditions (this corresponds to a change in the pressure

0.03 kPa.l/min for the leakage test for a pressure drop).

• Clean the terminal unit from possible impurities and check the integrity

and presence of all labels and markings.

Installation and testing procedures must be in compliance with EN ISO

7396-1 and EN ISO 5359 standards.

7. OPERATIONS

7.1. BEFORE OPERATION

7.1.1. PREPARATION FOR USE OF TU

• Check if the TU (including label) does not show any visible external

damage. If there are signs of external damage, ensure the unit is not

and label. Contact the responsible personnel and call service - see

chapter 9.2.

• Check visually if the product is clean, if cleaning is needed follow pro-

cedures described further in this instruction for use.

TU can be used only for the gas speciﬁed on the cover. Never try to use

it for dierent type of gas.

7.2. CONNECTION OF TERMINAL UNITS

7.2.1. LIST OF KNOWN ACCESSORIES

Hoses, ﬂow rate meters, fans, underpressure reducing valves, suction eje-

tors.

10/96

Any devices used with TU must be compatible with the gas for which TU

is intended for.

Always make sure the device is connected ﬁrst and then used on the

patient.

7.2.2. CONNECTION OF MEDICAL DEVICES TO QUICK CONNEC

TORS

• Connect the medical devices used in accordance with EN ISO 9170-1

and the appropriate national standards SS8752430.

• Check whether there is gas on the outlet of the medical device con-

nected (e.g. by setting the ﬂow rate of the ﬂow rate meter connected).

• Use the medical device connected in accordance with the manufac-

turer’s instructions.

7.3. AFTER EVERY USE

Disconnect the medical devices used from the terminal unit.

8. CLEANING

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

water and rinsed with clean water. Disinfection can be carried out with an

alcohol-based solution (spray or wipes).

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

that they are compatible with brass, plastic materials of components, and

gas.

Do not use cleaning solutions containing ammonia!

Do not immerse in water or any liquid.

Do not expose to high temperature.

9. LIFETIME OF THE PRODUCT, MAINTENANCE

AND SERVICING

9.1. BATCH NUMBER AND PRODUCTION DATE

The number stamped on the terminal unit body consists of the following

data: GCE logo XXXXXXX

XXXXXXX: batch number

For example: The number 7366506 indicates a product with the batch

number 7366506.

9.1.1. PRODUCT LIFETIME AND WASTE MANAGEMENT

Housing - the maximum lifetime of this part of the product is given by the

lifetime of non-metallic materials used in the device and equals to the life-

time of materials used in the pipeline distribution system.

Indice

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