GCE PRESSURE WATCH Návod na používanie

INSTRUCTION FOR USE

ANVÄNDARANVISNING

NÁVOD K POUŽITÍ

HASZNÁLATI UTASÍTÁS

GCE HEALTHCARE

CENTRAL GAS SUPPLY SYSTEM

CENTRALGASANLÄGGNING

EN

SV

PRESSURE WATCH

REDUKČNÍ STANICE CS

HU

KÖZPONTI GÁZELLÁTÓ RENDSZER

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EN

1. FOREWORD

These instructions for use cover essential information for the entire life cycle of the Pressure

Watch:

• Installation

• Operation

• Alarm conditions, see Alarm Systems

• Maintenance

• Cleaning

• Disposal.

GCE Medical central gas system is medical devices 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 standard.

2. INTENDED USE

The Pressure Watch is monitoring and supervising the gas pressure in a clearly stated part of

the Hospital Central Gas Supply System. It is ﬁtted with quick couplings for emergency supply,

gauges and pressure sensors. The pressure sensors gives a signal for high or low gas pressure

and can be connected to an Alarm system. Together with the Pressure Watch shall always be

used alarm providing all alarms according to standard (like Gas alarm).

This instruction for use details the operational and safety procedures for the Pressure Watch.

The Pressure Watch is available for Oxygen, Nitrous Oxide* and Compressed Air, it can also be

used for Carbon Dioxide*, Nitrogen, Vacuum and gas blends for Medical Applications. These

Pressure Watches are designed to operate at a maximum service pressure of 16 bar.

The system should not be put into service before these procedures are thoroughly read and the

operator is familiar with controls described in this instruction for use.

* The Pressure Watch shall be installed in room with minimal temperature of 10 °C.

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.

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 (take a great care in the use of hand creams)

• Water

• Dust

ENGLISH

INSTRUCTION FOR USE: PRESSURE WATCH

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The product and its associated equipment must be prevented from tipping over, turning over

or falling.

Always maintain oxygen cleanliness standards.

Only use the product and its associated equipment in well ventilated area.

National 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 +40°C -30 °C +70 °C

20 % 70% 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 can be emergency supplied by cylinder gases and the

following general practices are our recommendations for the safe, ecient storage and use of

such compressed gases.

3.2.CYLINDER STORAGE

Storage area shall be designed according to valid standard, here are some recommendations;

Well ventilated with weather protection.

Free from ﬁre risk. Keep away from sources of heat and ignition. Designated as a ‚no smoking’

area.

Clearly marked as a gas store with appropriate hazard warning signs (e.g. ﬂammable, toxic,

radio active etc.).

Kept clear with access restricted to authorised personnel.

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

apparatus etc.)

3.3.COMPRESSED GAS CYLINDERS IN STORAGE SHOULD BE

• Standing upright where designed for this.

• Properly secured to prevent overturning.

• Fitted with valve protection devices (e.g. Caps, guards etc.) where supplied.

• Segregated in the storage area according to the various categories (e.g. Flammable, oxidant

etc.).

• Segregated in the storage area according to content and clearly designated full or empty.

• Managed to ensure that the oldest stock is used ﬁrst.

• Checked periodically for general condition.

3.4.PERSONNEL: WHO ENTER THE STORAGE AREA SHOULD BE

• Responsible and competent to maintain the gas store and its contents as above.

• Familiar with and able to identify the contents of the gas containers and their potential hazards.

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3.5.EMERGENCY PROCEDURES:

An emergency results from;

• A ﬁre near or in the cylinder manifold room.

• An unintended leak of gas from the cylinders or pipeline.

• Some other potential or actual incident which will aect the integrity of the manifold installation.

PROCEDURE TO FOLLOW:

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

• Evacuate all personnel from the immediate danger area.

IN CASE OF FIRE, REMOVE ALL CYLINDERS:

• Close the cylinder valve(s) on all cylinder(s)/ cylinder bundles.

• Close the bank isolating valve(s).

• Disconnect the high pressure hoses.

• Move the cylinders to a safe area using a suitable cylinder trolley.

IN THE CASE OF AN UNCONTROLLABLE ESCAPE OF GAS:

• Open the doors to the manifold room to ventilate the area.

• Do not introduce sources of ignition into the area.

It is important that ready access to these instructions is given at all times and that the product

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 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

knowledge required for the gas in use.

5. PRODUCT DESCRIPTION

The Pressure Watch is monitoring and supervis ing the gas pressure in a clearly stated part

of the Hospital Central Gas Supply System. It is ﬁtted with shut o valves, quick couplings for

emer gency supply, gauges and pressure switches. The pressure switches gives a signal for

high or low gas pressure and can be connected to an Alarm system. Together with the Pressure

Watch shall always be used alarm providing all alarms accord ing to standard (like Gas alarm).

The Pressure Watch can also be delivered with bottom connec tion version (pipes through, see

picture) or with Emergency Source (ES) and be installed recessed or exposed.

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5.1.THE PRESSURE WATCH ON THE PICTURE IS A 3GAS VERSION

A – Inlet tube connection

Tube for gas suplly inlet

B – Inlet pressure gauge

On the gauge is possible to see the inlet pressure of the gas supply

C – Shut o valve

In order to be able to open or close the gas supply, the blue handle is turned a quarter of a

revolution. Each valve shall be marked with gas type so that the right gas is shut o at leakage

or service. The marking on the plate shows if the valve is open or closed, i.e. if the handle is in

line with the marking the valve is open and the gas ﬂows freely.

D – Outlet pressure gauge

On the gauge is possible to see the outlet pressure

E – Low pressure sensor

The switch gives a signal for low gas pressure of the gas supply

F – High pressure sensor

The switch gives a signal for high gas pressure of the gas supply

G – Quick coupler ( gas speciﬁc)

Via the quick coupler can be connected the reserve gas cylider when the main gas supply is

disconnect.

H – Outlet tube connection

Tube for gas supply outlet

Note: The pressure watch is also available with pressure transmitters 4-20 mA.

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5.2.THE PRESSURE WATCH WITH EMERGENCY SOURCE ON THE

PICTURE IS A 3GAS VERSION

The Pressure Watch with Emergency Source consists of all devices as Pressure Watch only

Emergency Source ES is ﬁtted to provide the gas delivery when the main gas supply is out of

order

J – Inlet tube connection

Tube for emergency gas supply inlet

K – Inlet pressure gauge

On the gauge is possible to see the inlet pressure of the emergency gas supply

L – Shut o valve

In order to be able to open or close the emergency gas supply, the blue handle is turned a

quarter of a revolution. Each valve shall be marked with gas type so that the right gas is shut o

at leakage or service. The marking on the plate shows if the valve is open or closed, i.e. if the

handle is in horizontal position like on the picture the valve is closed and the gas does not ﬂow.

5.2.1.PHYSICAL ISOLATION

Each Pressure Watch or Pressure Watch ES (except for vaccum system) is equipped with a

physical isolation. These device shall be ﬁtted to each pipe line when modiﬁcations are needed

to existing system. It shall be ﬁtted manually to pipe line by trained person.

Place for physical isolation is marked with this label –

6. INSTALLATION

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

according 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.

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

service 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

Please consult the positioning of the Pressure Watch with gas supplier and designer. Mount the

Pressure Watch at the height to suit either cylinders or cylinder bundles.

Be aware that only upper screw hold the entire weight of the product. Size of used screws

shall conform to total load.

6.1.1.PRESSURE WATCH COMPONENTS

16

3

5

42

1. Door

2. Valve box

3. Attachment

4. Handle

5. Sealing hole

6. Inner cover

The base of the Pressure Watch is best placed 1.4 m over the ﬂoor. It must be possible to read

the gauges, and to have access to the valves. Attention should be paid to the passing bed

transports so these will not cause harm to the Pressure Watch.

6.1.2.RECESSED MOUNTING:

Make a hole in the wall, for 1-3 valves 490x350 mm (490x540 mm for the Pressure Watch

with Emergency Source). Put cross bars or other means of attachment, which will be used for

the mounting of the Pressure Watch, at determined height. The wall panels to be mounted in

a way, that makes the front of the Pressure Watch covers the opening, and at the same time

seal possible leaks between the wall and the unit. Fasten the valve box (2) on two bolts with

the screws. The distance from the attachment (3) to the leading edge of the box is adapted to

mounting on a wall with double 13 mm gypsum wallboards. If the wallbox is mounted in walls of

other construction, the attachment must be adjusted to that wall construction.

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EN 1-3 valves seen from above

Side view

Pressure Watch

Side view

Pressure Watch with Emergency Source

6.1.3.EXPOSED MOUNTING:

Get the bolt attachment for the unit box ready. Drill four holes (at minimum) in the box for

mounting on the bolts.

Fasten the valve box (2) to the wall using the screws. Disassemble the attachments (3) and use

the enclosed plastic plugs to cover the holes.

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1-3 valves seen from above

Side view

Pressure Watch

Side view

Pressure Watch with Emergency Source

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6.1.4.PIPE CONNECTION

The sequence of the gases is given by the gas piping in the medical facilities and the relevant

local standards.

1. The valve need not to be demounted at soldering.

2. Cut the tubes in a perpendicular fashion to suitable length. Grade the tubes, and make sure

there are absolutely no traces of copper splint. Soldering should be done with nitrogen as

the protecting gas inside the tube line according to the SIS HB 370

3. Connect the copper tubes and solder them together.

4. Chill the tubes at soldering.

6.1.5.FINAL MOUNTING

At recessed mounting, the wall is ﬁnished and the empty space between the box (2) and the

wall is tightened. Fasten the wire into the sealing hole (5).

6.2.FITTING INLET AND OUTLET CONNECTION

Solder diameter 22 mm pipe.

6.3.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 .

7. OPERATION

7.1.START UP OF THE PRESSURE WATCH

When the Pressure Watch is completely installed.

• Make sure that the incoming gas is right for their respective connections.

• Before opening the valves B check the gauges A, if the gas pressure is correct for each gas.

• Open the valves B slowly.

• Check the gauges C, if the gas pressure is correct for each gas.

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

7.2.START UP OF THE PRESSURE WATCH WITH EMERGENCY SOURCE

When the Pressure Watch with Emergency Source is completely installed.

• Make sure that the incoming gas is right for their respective connections.

• Ensure the valves B on the main gas line are closed

• Before opening the valves E on the Emergency Source gas line check the gauges D on the

Emergency Source gas line, if the gas pressure is correct for each gas.

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• Open the valves E on the Emergency Source slowly.

• Check the gauges C, if the gas pressure is correct for each gas.

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

• Close the valves E on the Emergency Source.

• Before opening the valves B on the main gas line check the gauges A on the main gas line, if

the gas pressure is correct for each gas.

• Open the valves B on the main gas line slowly.

• Check the gauges C, if the gas pressure is correct for each gas.

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

For operating the alarm system see Instruction For Use for the alarm.

7.3.CONTROL THE FUNCTION OF THE PRESSURE SENSORS

1. HIGH PRESSURE OXYGEN.

Close valve B for Oxygen, connect a Oxygen gas cylinder to the female QC for emergency

supply. Increase the pressure to preset high pressure level, the alarm gives an signal and the

diod light is ﬂashing.

2. LOW PRESSURE OXYGEN.

Remove the gascylinder and use a male probe (quick connection) to decrease the pressure, to

the preset low pressure level and wait for the alarm.

3. OPEN THE VALVE AGAIN SLOWLY.

Check the alarm levels for all gases in the same way.

7.4.PHYSICAL ISOLATION

Each Pressure Watch or Pressure Watch ES (except for vaccum system) is equipped with a

physical isolation. These device shall be ﬁtted to each pipe line when modiﬁcations are needed

to existing system. It shall be ﬁtted manually to pipe line by trained person.

7.4.1.FITTING PROCEDURE OF PHYSICAL ISOLATION

1. Disassemble the fronplate and the inner cover

2. Close the shut o valve on adequate pipe line and ensure the the gas is no more ﬂowing

through

3. Disassemble both switches and unscrew the cap nut from the valve

4. Put the physical isolation between the valve and the connection

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Physical isolation – Copper blanking plate

5. Screw back and tighten the cap nut on the valve

6. Slowly open the shut o valve and check if the gas is ﬂowing through

7. If yes, please check the assembly of the physical isolation again

8. If the gas is no more ﬂowing through the physical isolation is ﬁtted correctly

9. Close the shut o valve

When modiﬁcations are ready then the physical isolation has to be disassembled from the

pipe line!

7.4.2.DISASSEMBLY OF THE PHYSICAL ISOLATION

1. Ensure the shut o valve is closed

2. Unscrew the cap nut from the valve

3. Take out the physical isolation

4. Screw back and tighten the cap nut on the valve

5. Screw back and tighten the switches – low pressure switch to LP side and high

pressure on the HP side (see the LP and HP marking on the brass block)

6. Slowly open the shut o valve and check if the pressure gauge indicates any pressure

7. If yes, check the external leakage of the connections

7.5.ALTERNATIVE OF PRESSURE SENSORS

ALTERNATIVE 1. PRESSURE SWITCHES:

To set the pressure switches ”PS” (repeat for every PS):

1. Connect an Ohm-meter to the two pins of PS.

2. Rise and sink the pressure by using the quick coupling (and if necessary a spare cylinder).

3. Note at what pressure the PS change from closed to open (seen on the Ohm-meter,

closed=short circuit, open=no contact between the pins). Closed PS = No alarm. Open PS=

Alarm

4. If needed; adjust the PS by operating the screw positioned between the two pins. Turning

the screw clockwise sets the alarm point corresponding to a higher pressure.

5. Reiterate point 2 to 4 until you are pleased with the settings.

6. Connect the PS to Gas alarm according to enclosed Gas alarm instruction.

ALTERNATIVE 2. PRESSURE TRANSMITTER 420 mA:

4 mA is equivalent to 0 bar and 20 mA to the maximum pressure of the pressure transmitter.

The pressure transmitter is linear and you connect it directly to central computer system or local

alarm system. See also IFU for the master system.

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8. EMERGENCY GAS SUPPLY

8.1.EMERGENCY GAS SUPPLY

On signal of alarm condition, the display is indicating low or high pressure for one or more

gases. The alarm condition should be recorded and the necessary action taken.

1. Pressure Watch not equipped with central Emergency Supply, follow instructions below.

2. Pressure Watch equipped with central Emergency Supply, follow instructions below.

1. GAS TYPE

Mute the acoustic signal by pressing the button.

Display of the alarm gives visual indication which

gas (gases) has incorrect pressure.

2. CLOSE THE VALVE

Open the hatch and close the inlet shut o valve

for the gas which causes the alarm.

3. CONNECT THE RESERVE GAS CYLINDER

Connect the suitable hose from the cylinder regulator

to the quik connector in the Pressure Watch.

4. OPEN THE CYLINDER VALVE CAREFULLY

Put both hands on top of the cylinder valve and

open the emergency gas slowly.

5. CHECK THE ALARM

Check on the display that the alarm returns to

normal mode. If the alarm does not return to normal

mode, see point 1.

6. INFORM THE RESPONSIBLE PERSONNEL

Telephone number to responsible technician. The

responsible personnel checks the equipment, replaces

the gas bottles if necesarry and resets the equipment

to normal mode.

ALARM

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9. ALARM CONDITIONS

1. GAS TYPE

Mute the acoustic signal by pressing the button.

Display of the alarm gives visual indication which

gas (gases) has incorrect pressure.

Open the hatch and close the inlet shut o valve

for the gas which causes the alarm.

4. CHECK THE ALARM

3. OPEN THE VALVE

2. CLOSE THE VALVE

Check on the display that the alarm returns to

normal mode. If the alarm does not return to

normal mode, see point 1.

Open the shutt o valve on the Emergency Supply for

the gas which causes the alarm.

5. INFORM THE RESPONSIBLE PERSONNEL

Telephone number to responsible technician. The

responsible personnel checks the equipment,

replaces the gas bottles if necessary and resets the

equipment to normal mode.

NORMAL

SUPPLY

EMERGEN-

CY SUPPLY

NORMAL

SUPPLY

EMERGENCY

SUPPLY

ALARM

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GENERAL FUNCTION OF ALARM SYSTEMS

Gas alarm monitors the alarm conditions from the Pressure Watch. The display shows high or

low pressure for 1-3 gases.

See instruction for use for Gas alarm.

10. PERFORMANCE DATA

GRAPH – EMERGENCY SUPPLY (QC)

Pressure drop test. Inlet pressure 4; 4,5 and 5

bar. Emergency supply (QC). The oxygen

channel.

Capacity Emergency Supply (QC) at 500 kPa (5

bar) and Pressure drop 0.5 bar:

approx. 293 l/min)

Maximum inlet pressure: 1000 kPa (10 bar)

GRAPH – NORMAL SUPPLY

Pressure drop test. Inlet pressure 4; 4,5 and 5

bar. The oxygen channel.

Capacity Normal Supply at 500 kPa (5 bar) and

Pressure drop 0.1 bar: approx. 1100 l/min

Maximum inlet pressure: 1000 kPa (10 bar)

11. ROUTINE MAINTENANCE INSTRUCTION

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

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

THE FOLLOWING ROUTINE CHECKS SHOULD BE MADE ON A WEEKLY BASIS:

• 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

aect the continuing safe operation of the manifold.

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. programme.

• 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 ﬁtted, 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.

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• Check connecting nuts and seating faces are undamaged.

• Check o-rings 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.

• 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 ﬁre 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 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.

12. SCHEME OF EXAMINATION

GCE recommendations for a Written Scheme of Examination:

EQUIPMENT EXAMINATION

INTERVAL

GUIDELINES OF WRITTEN SCHEME

1. HOSES 5 years a. Visual, external examination.

b. Replace with new hose.

c. Record replacement.

2. PIPE WORK 1 year a. Visual, external examination.

b. Pressure test.

c. Record all details of examination.

3. REGULATORS FOR

EMERGENCY SUPPLY 5 years a. Replace with new or manufacturer’s refurbished

unit.

b. Record all details.

4. VALVES 5 years a. Replace seals/glands/o-rings.

b. Functional test.

c. Record all details of examination.

13. ACCESSORIES

Standard accessories – Gas alarm.

GCE recommends the use of GCE Shut O Valves, GCE Collecting Branches, GCE Pressure

hoses.

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

Use only genuine GCE spare parts!

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14. 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.

15. PRODUCT LIFE TIME AND MAINTENANCE

15.1.PRODUCT LIFE TIME AND WASTE MANAGEMENT

Maximum life time of the product is 10 years from the manufacturing date at compliance of

Examination schedule – see chapter 11. At the end of the product’s life time (10 years maximum),

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.

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

concentrations exceeding 0.1% are included in any GCE product.

15.2.MANUFACTURING DATE

The manufacturing date is included in the product serial number which is marked on the label.

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.

GCE recommends to use original packaging when is withdraw from operation.

15.3.MAINTENACE

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

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.

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APPENDIX:

Nr 1 – Technical speciﬁcations and performance data

Nr 2 – Testing report for relevant Serial Number of the Pressure Watch

MANUFACTURER:

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

Zizkova 381 Fax : +420 569 661 602

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

16. TRANSPORT AND STORAGE

Before ﬁrst use, the product shall be kept in its original packaging.

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.

17. 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! Weight of product

Humidity limit SN Serial number

Temperature limit REF Reference number

Keep dry! LOT Batch code

Date of manufacture Manufacturer

Use by date Fragile, handle with care

Inlet parameter Outlet parameter

18. 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 standa

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1. FÖRORD

Dessa instruktioner omfattar väsentlig information för Tryck Övervakarens hela livscykel::

• Installation,

• Handhavande

• Larm förhållanden, se alarmsystem

• Underhåll,

• Rengöring,

• Deponering.

GCE Medicinska centralgas system är medicinsk utrustning klassiﬁcerat i klass IIb enligt Medical

Device Directive 93/42/EEG.

De överensstämmer med väsentliga kraven i 93/42/EEG Medical Device Directive, och är

baserade på standard EN ISO 7396-1 med tillägg och ändringar.

2. AVSEDD ANVÄNDNING

Tryck Övervakaren visar och övervakar gas trycket I en avgränsad del av Sjukhusets

Centralgasförsörjningssystem.

Den är utrustad med gasspeciﬁka snabbkopplingar för nödförsörgning, manometrar och

tryckvakter. Tryckvakterna ger signal för högt och lågt gas tryck och kan anslutas till ett larm

system. Tryck Övervakaren skall alltid utrustas med ett larmsystem som ger alla larm som krävs

enligt standard, (till exempel gas larm).

Dessa instruktioner innehåller detaljerade handhavande och säkerhets anvisningar för Tryck

Övervakaren. Tryck Övervakaren ﬁnns för Oxygen, Lustgas N2O, A-luft och Instrumentluft, den

kan också användas till Koldioxid CO2*, Nitrogen vacuum och gasblandningar för medicinska

applikationer. Tryck Övervakarena är designade för maximalt inloppstryck 16 bar.

Systemet skall inte tas i drift fören dessa anvisningar är genomlästa och operatören är bekant

med handhavandet och funktionerna som beskrivs i dessa användar instruktioner.

* Tryck Övervakaren skall installeras i utrymme med en temperatur på minst 10 °C.

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

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

Produkten måste installeras av en kvaliﬁcerad person och genom överensstämmelse av alla

krav i EN ISO 7396-1 i dess ändrade lydelse

För att garantera säkerheten för patienten, kontrollera utrustningen och tillbehören som

används med produkten före användning så att data och prestanda överensstämmer med

den avsedda användningen av produkten.

Produkten får inte under några omständigheter modiﬁeras av annan än tillverkaren!

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

SVENSKA

INSTRUKTION: TRYCK ÖVERVAKARE

20/72

SV

3. SÄKERHETSANVISNINGAR FÖR HANTERING,

TRANSPORT AND LAGRING

Håll produkten med tillbehör borta från:

• värmekällor (eld, cigaretter, …),

• brandfarliga material,

• olja och fett (var särskilt försiktig vid användning av handkrämer),

• vatten,

• damm.

Produkten med tillhörande utrustning måste förhindras från att falla omkull.

Använd endast produkten med tillhörande utrustning i väl ventilerade områden.

Upprätthåll alltid en renhet motsvarande Oxygen standard.

Nationella lagar och bestämmelser skall alltid följas för att undvika olyckor och för att skydda

miljön.

DRIFT FÖRUTSÄTTNINGAR LAGRING OCH TRANSPORT

MIN MAX MIN MAX

-10 °C +40°C -30 °C +70 °C

20 % 70% 20 % 70 %

600 mbar 1200 mbar 600 mbar 1200 mbar

Endast behörig personal skall ha tillträde till anläggningen – risk för fel användning.

3.1.DRIFTSÄKERHET

Panelen som beskrivs I denna instruktion kan nödförsörjas med gasﬂaskor. Följande allmän

praxis är våra rekommendationer för en säker och ändamålsenlig förvaring av dessa gasﬂaskor

med komprimerade gaser.

3.2.LAGRING AV GASFLASKOR

Förvaringsutrymmet skall vara utformat enligt gällande standard, till exempel:

• Ventilerat, väderskyddat utrymme.

• Fri från brännbara lättantändliga föremål och annan brandrisk, rökförbud.

• Tydligt skyltad som gasförråd med varningsskyltar, (tex. brandrisk, giftig, radioactiv...)

• Blockera inte ingångar och tillåt tillträde endast för behörig personal.

• Utrusta med lämplig säkerhets-/nöd- utrustning, (tex. brandsläckare, andningsutrustning etc.)

3.3.GASFLASKOR I GASFÖRRÅD SKALL VARA

• Stående uppställda, om de är designade för detta.

• Säkrade för att förhindra omkullvältning.

• Försedda med ventilskydd (tex. kåpa, guards etc.) om det tillhandahålls.

• Åtskiljda i förrådet med avseende på gastyper (tex. brännbara, oxiderande etc.)

• Åtskiljda i förrådet med avseende på innehåll, klart markerade med full eller tom.

• Med möjlighet att säkerställa att de äldsta i lager, används först.

• Kontrollera regelbundet det allmäna förhållandet på lagret.

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