Getinge GE-224, Citomat 164 User and service manual

STERILIZER

GE224c VAC

Citomat 164 Vac

Manual

2 2

Contents

DECLARATION OF CONFORMITY 1 3

INTRODUCTION 5

ARNING

INSTALLATION 6 STERILIZER CONTROLS 8 DISPLAY 10 DESCRIPTION OF THE PROCESS 11 THE STERILIZATION CYCLE 12 OPERATING INSTRUCTIONS 13

TERILIZATION

ETWEEN STERILIZATIONS

LOSING DOWN FOR THE DAY

MALFUNCTIONS 15

AULT CODES

PROCESS INTERRUPTED 16

SAFETY DEVICES 17

AFETY CHECKING

MAINTENANCE 18 YEARLY MAINTENANCE SERVICE 19 DESIGN OF THE STERILIZER 20

OMPONENTS

EARCHING FOR LEAKS

SERVICE PROGRAM 27

ERVICE PROGRAMME SCHEDULE

TECHNICAL DATA 31 TROUBLESHOOTING 32

ETINGE SKÄRHAMN’S POLICY

LOW CHART

OOR CHART

LECTRICAL DRAWING

IRCUIT BOARD

35 36

: 34

SPARE PARTS LIST 38

OMPONENTS

7817Mannual Eng D Fr o m ser no: 981412040 980401

DECLARATION OF CONFORMITY

Manufacturer

Name

Adresse

Telefon

Product 6

Machine reference 7

Sterilizer: GE 224c Vac / Citomat 164 Vac

Type number

978046101, 978046106, 978046103, 978046105

We declare under our sole responsibility that this product is in conformity with the following standards or standardization documents: 8

SS-EN50081-1, SS-EN50081-2 SS-EN50082-1, SS-EN50082-2 SS-EN61010-1, SS-EN61010-2-041 SS-EN60204-1

According to the provisions of the regulations: 9

89 / 336 / EEC AFS 1994:39 LVD 73 / 23 EEC MDD 93 /42 EEC (class IIa)

Place, date of issue

Skärhamn 980714

Position of issuer

Managing director

Signatur of issuer 12

Getinge Skärhamn AB

Box19 S-47121 Skärhamn

+46 0304 671020

Translation of ”DECLARATION OF CONFORMITY”

1. KONFORMITÄTSERKLÄRUNG

2. Hersteller

3. Name

4. Anschrift

5. Telefon

6. Erzeugnis

7. Beschreibung der Machine

8. Wir erklären in alleiniger Verantwortung, dass dieses Produkt mit den folgenden Normen oder normativen Dokumenten übereinstimmt

9. Gemass den Bestimmungen der Richtlinien

10. Datum

11. Titel des Ausstellers

12. Unterschrift

NL-B

1. VERKLARING VAN OVEREENKOMST

2. Fabricant

3. Naam

4. Adres

5. Telf.nr.

6. Produkt

7. Machine type

8. Wij verklaren dat dit produkt voldoet aan de volgende normen of normatieve dokumenten

9. Volgens de bepalingen van de richtlijnen

10. Datum van afgifte

11. Functie

12. Handteckning

FIN

1. YHDENMUKAISUUSILMOI TUS

2. Valmistaja

3. Nimi

4. Osoite

5. Puh

6. Tuote

7. Viite

8. Todistamme täten ja vastaamme yksin siitä, että tämä tuote en allalueltujenstandardien ja standardoimisasiakirjojenvaati musten mukainen.

9. Seuraavien ohjeiden määraysten mukaisesti

10. Päivämäärä

11. Toimi yrityksesså

12. Allerkirjoitus

1. ERKLÆRING VEDR. ENHETLIGHET

2. Produsent

3. Navn

4. Adresse

5. Telefon

6. Produkt

7. Type nummer

8. Vi overtar ansvaret for at

dette produkt er i overensstemmelse med følgende standarder eller standard-dokumenter

9. I samsvar med bestemmelsene i direktivene

10. Dato

11. Titel

12. Signatur

1. ÖVERENSKOMMELSED EKLARATION

2. Tillverkare

3. Namn

4. Adress

5. Telefon

6. Produkt

7. Typbeteckning

8. Vi intygar och ansvarar för att denna produkt överensstämmer med följande normer och dokument.

9. Enligt bestämmelserna i direktiven

10. Datum

11. Titel

12. Signatur

1. DICHIARAZIONE DI CONFORMITA

2. Produttore

3. Nome

4. Indirizzo

5. Telefono

6. Prodotto

7. Riterimento maccina

8. Assumendone la piena responsabilità, dichiariamo che il prodotto é conforme alle sequenti normative ed al relativi documenti.

9. In base alle prescrizioni delle directtive.

10. Data di emissione

11. Qualifica del dichiarante

12. Firma del dicharante

1. ERKLÆRING VEDR. ENSARTETHED

2. Producent

3. Navn

4. Adresse

5. Telefon

6. Produkt

7. Maskine ref.

8. Vi erklaerer undere almindeligt ansvar at dette produkt er i ovensstemmelse med følgende normer eller normative dokumenter

9. I henhold til bestemmelserne i direktiverne

10. Dato

11. Titel

12. Signatur

1. DÉCLARATION DE CONFORMITÉ

2. Fabricant

3. Nom

4. Adresse

5. Telephone

6. Produit

7. Ref de la machina

8. Nous déclarons sous notre propre responsabilité que ce produit est en conformité avec les normes ou documents normalisés

9. Conformément aux termes des réglementations

10. Date

11. Fonction

12. Cachet et signature

1. DECLARACIÓN DE CONFORMIDAD

2. fabricante

3. Nombre

4. Direccion

5. Telefono

6. Producto

7. Referncia de la machina

8. Declaramos bajo nuestra

sola responsabilidad que este producto está en conformidad con las normas o documentos normalizados siguientes

9. De acuerdo con las regulaciones

10. Fecha

11. Cargo

12. Firma

1. DECLARAÇÂ DE CONFORMIDADE

2. Fabricante

3. Nome

4. Mozada

5. Telefone

6. Producto

7. No. artigo

8. Declararnos sob nossa exclusiva responsabilidade que este producto cumpre as sequintas normas ou documentos normativos

9. De acordo com as disposiçoes das directivas

10. Data

11. Cargo

12.

Assinatura

NTRODUCTION

Variants

These sterilizers are marketed under two brands which, apart from the names, are identical: Citomat is aimed primarily at the dental market and the GE versions primarily at the medical sector.

Sterilizers GE224c/Citomat 164 and GE224c VAC/Citomat 164 VAC are bench sterilizers which perform pre-programmed sterilization processes fully automatically.

Two versions of the sterilizer are available: the GE224c/Citomat 164 and the GE224c VAC/Citomat 164 VAC. The GE224c/Citomat 164 incorporates pulsed air removal and radiant post-drying, and is suitable for sterilization of thermally stable items such as those made of metal, glass, plastic and rubber.

The GE224c VAC/Citomat 164 VAC has, in addition, air removal and drying with vacuum, which means that it can also be used for sterilizing textiles, hollow instruments and packaged items.

General

Sterilizers GE224c/Citomat 164 and GE224c VAC/Citomat 164 VAC are bench sterilizers which perform pre-programmed sterilization processes fully automatically. The sterilizers use steam which is produced by a separate steam generator inside the unit. The steam generator is supplied with distilled or de-ionised water from an integral tank.

Warning

Very important text and warnings are marked with a double border like this.

• The sterilizer operates with pressurised steam, so parts of the sterilizer may become hot. Always take great care when working with the sterilizer.

• Only clean the sterilizer when it is cold.

• The tank cover can become very hot during certain parts of the process.

• Never lift the tank cover when the safety valve is operated.

• Take care when emptying the tank; the water may be very hot.

• The items in the sterilizer will be hot after the sterilization process.

• When the door is opened, hot steam may flow out of the chamber.

• When handling and loading items, remember that the chamber and the door are very hot.

Warranty

A one-year warranty is given on components, but not on components regarded as consumables, e.g. door packings. For servicing work, reference should be made to agreements with the supplier. IMPORTANT: The warranty on the delivered product is invalidated by faulty installation.

The legal rules relating to manufacturer's liability only apply if the instructions in this manual have been followed

NSTALLATION

Internal transport

The simplest way of moving the sterilizer is to use a pallet truck or trolley, capable of carrying at least 110 kg.

Unpacking

Check that the product is undamaged. Notify any damage caused during transport immediately to the transport company. Check that the items received are in accordance with the order.

Setting up

Store the sterilizer indoors at a temperature between +2 °C and 40 °C and at a relative humidity not exceeding 95%, non-condensing.

The sterilizer should preferably be installed by an authorised technician. There should not be a cupboard or shelf immediately above the sterilizer: it must be possible to fill and clean the water tank from the top of the unit without difficulty.

Position the sterilizer so that there is at least 10 cm free space all round it, in order to ensure the necessary air circulation.

The ambient temperature around the sterilizer should not exceed 35 °C. It is most important for correct performance that the chamber should slope backwards.

• Place the sterilizer on a firm base, that will not be damaged by any unintentional water spills. The external dimensions of the unit are intended to fit on a normal worktop with a width of 600 mm.

Min.distance to wall : 100mm Free space above sterilizer min.: 200mm The sterilizer must lean backwards

Adjustable feet

• Make sure that the support surface can carry a load of at least 120 kg.

• Fit the door handle.

• Make sure that the sterilizer chamber slopes slightly backwards: adjust it using the front feet of the unit.

If the surface of the water is parallel with the line in the tank, the slope is satisfactory.

• Set up the Care Instructions and Description of Operation near the sterilizer.

• Make sure that the operator has access to, and has read, the Description of Operation.

• Collect all other documentation supplied with the sterilizer, and ensure that it is available throughout

the life of the sterilizer.

• Make sure that the technical documentation is available to the service technician.

holders for bags (to improve

• Check that there is a suitable power outlet in the vicinity of the sterilizer, and check that its voltage agrees with that shown on the sterilizer rating plate. The outlet must be earthed (grounded) and protected by a 10 A fuse.

Warning: Connection to an incorrect power supply may have lethal results.

• If the sterilizer has been transported at temperatures below -5 °C, it may be necessary to reset the overheat protection device. (See the section entitled Controls for the position of the reset pushbutton.) If the indicator lamp and display panel do not light up when the sterilizer is connected to the power supply, this may have happened.

• Fill the water tank with distilled water or de-ionised water (maximum 30 µS/cm) to the maximum mark (about 5 litres), from the de-ionisation equipment recommended by the sterilizer manufacture.

Warning: Putting the wrong liquids in the water tank can result in injury or other danger.

• Make sure that all operational and safety features have been checked by an authorised technician before the sterilizer is used.

• If the sterilizer has been unused for a long time, the tank may need to be filled with water the day before starting, to allow any air bubbles to disperse.

Commissioning / Validation

A document entitled “Points to be checked on installation” accompanies every sterilizer. Check each point and return the document to the supplier or dealer.

If the sterilizer is used for the re-sterilization of medical instruments, the sterilizer must be validated before being put to use. We recommend EN-554 as a model. If a sterilized product is to be labeled with a CE-mark, the medical directive must be followed. Indicators If indicators are used to verify the process, we recommend those made by certified companies and fulfilling applicable standards. The following are used in the factory test runs. Browne, Euro TST B & D type test pack 134° C / 3.5 min, for vacuum/steam and the biological indicators used are of the following make: Boule Nordic AB: Type B stearothermophilus art. no. 3014-s.

Racks

Do not use the sterilizer without the racks as illustrated below ’

Nor with any accessories other than those supplied by Getinge Skärhamn AB. Examples include: Trays - instrument baskets tray handles - special

drying results) - deionisation equipment recorder / printer. Contact your dealer for information.

2 3 4 1

TERILIZER CONTROLS

1 Membrane key

• Program selection

2 Membrane key

• Start

3 Membrane key

• Reset (to reset faults)

4 Membrane key

• Stop

5 Display unit

• See section headed “Display unit”

6-9 Indicator lamps - yellow

• Program indication

10 Indicating lamp - Green

• Indicates ”Processs Finished”

11 Indicating lamp - Red

• Indicates “Error”

12 Pressure gauge

• Shows the chamber pressure

13 Front panel retaining screws

• The panel opens to the right. Unscrew the fixing screws first.

External panels must not be removed by anyone other than an authorised technician.

14 Manual safety valve operator (easing gear)

• Operating this during sterilization phase opens the safety valve.

15 Tank cover

• Covers the water tank.

16 Reset pushbutton, overheat protection (underneath the unit, left-hand side)

• See under ‘Installation/Setup’.

Never reset the overheating protection device without first removing the power plug from the electrical supply socket.

17 Level tube

• Shows the water level in the water tank.

• The level tube can be disconnected at the top and hinged forwards and downwards to empty the water

tank.

18 Door handle

• For closing and locking the sliding door.

• Closing - using the handle, slide the door carefully to its right-hand end position.

• Locking - turn the handle 90° clockwise.

19 Main on/off switch, fuses and connector

• On the rear left side of the unit.

• Fuses 2 x 10A (anti-surge).

ISPLAY

The sterilizer has a display which provides the user with information in the form of text. The following information is shown on the display:

Text on display Explanation

1. Heating up The sterilizer is heating up C<70oC SG<140oC Chamber temp.Current temp. Steam generator.

2. Select 0103 Select program with “PROGR” Number of cycles run 134 oC Textile Current program. (Starting position between

sterilization cycles)

3. Close the door. Prompt to close and lock the door (Operator has pressed start with door open)

During the process

4. 2,1 134 13 Current pressure - Current temp.- Minutes after start Sterilization Current sequence

After completion of the process

5. 0,0 100 15 Current pressure - Current temp. Process time, min. Finished Process is complete but door has not been opened.

6. Fault codes See “Malfunctions”

Incidental note concerning the indicated pressure after completion of the process:

As the pressure is measured by an absolute pressure sensor, the indicated pressure (when the door is closed and locked) is the current atmospheric pressure (ie a barometer). It is displayed until the door is opened.

Pressure

pressure

ESCRIPTION OF THE PROCESS

The use of a microprocessor in the sterilizer means that it can offer a large number of program variations. The programs shown below are supplied as standard.

Parameter

Temperature min oC 121 134 134 134 Pressure min kPa 104 203 203 203 Sterilizing time minutes 20 3.5 5 5 Total time empty chamber (approx) minutes

Atmospheric

The sterilizer may include further programs or modified programs, as described in its test records. NB: The program times shown above are approximate, and may be altered if standards or other factors

result in modified program sequences.

121Wrapped 134Flash 134 Wrapped 134 Textiles

33 7 18 23

Pre-treatment

Schematic pressure/time diagram for sterilizer with vacuum

Sterilizing

Post-treatment

Process

Time

Flash program

The flash program must only be used for solid unwrapped instruments. Note: Non wrapped sterilized instruments are either intended for immediate use in the same room where

the sterilizer is placed, or for non sterile storage, transport and application (eg. to prevent cross infection)

Bowie & Dick Helix

In addition to the previous standard programs, the sterilizer is equipped with test programs for "Bowie & Dick" and the Helix test. This is indicated on the display when the program is selected. A flash program shall be run immidiate before a B&D helix program.

HE STERILIZATION CYCLE

Type of material

The sterilizer has programmes for treating heat-stable materials such as metal, glass, plastic and rubber, unpacked or packed in paper or paper/plastic bags. The packaging material must comply with EN-868.

Heating

An unheated appliance is required. Turn on the power. Technical: The element that preheats the steam generator and chamber is connected to the power supply. The display shows ”Heating”. The temperature of the heater can be followed on the display as soon as the temperature exceeds 150° on the heater. When the temperature reaches 240°, ”Select” is shown on the display and the sterilizer is ready to start.

Pre-treatment

The pre-treatment part of the cycle purges the air from the sterilization chamber and the items in it. The air obstructs the necessary contact between the steam and the micro-organisms to be killed. The moistening that is crucial for eliminating the micro-organisms also takes place during the pretreatment phase.

There may also be a preheating phase, the purpose of which is to raise the temperature of the items to be sterilized to a higher temperature before the real start of the pre-treatment phase. This reduces the quantity of condensate resulting from the subsequent admission of steam and thus, finally, drier items.

Technical: The pre-treatment consists of a) blowing-through when pump 1 and MV-1 are opened alternately for a particular time, b) pressure reductions when MV-1, fan and pump 2 are connected to the power supply to a pre-programmed value (e.g.–0.6 bar), c) pressure rise when pump 1 starts and runs to a pre-programmed value. The sterilization pressure must be reached in the last rise in pressure. When sterilization pressure and sterilization temperature have been achieved for temperature sensor T0, ”sterilization” appears on the display.

Sterilization

It is during the sterilization phase that the micro-organisms are actually killed. The sterilization phase lasts for a preset number of minutes at the preset temperature and pressure.

Technical: The sterilization phase continues for a pre-set number of minutes at pre-set temperature/pressure. The pressure is regulated using pump 1, which is started as required.

Post-treatment

The purpose of post-treatment is to reduce the moisture content of the items being sterilized. During post-treatment, the pressure falls to atmospheric pressure or lower, depending on which program

was selected. Most programs in sterilizers with vacuum function have a “vacuum phase", in order to reduce the boiling point of the residual condensate, thus leaving the items drier. At the end of the vacuum phase, air is drawn in through a sterile filter until the chamber reaches atmospheric pressure.

Technical:

pre-programmed value, a clock is started. When the time has elapsed, MV-1 closes and MV-2 opens, air being drawn in via the air filter and the pressure rising towards atmospheric pressure.

MV-1, fan and pump 2 are connected to the power supply. When the pressure reaches the

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