Getinge GE-224, Citomat 164 User and service manual

STERILIZER

GE224c VAC

Citomat 164 Vac

Manual

1

	2
Contents
DECLARATION OF CONFORMITY 1	3
INTRODUCTION	5
WARNING	5
INSTALLATION	6
STERILIZER CONTROLS	8
DISPLAY	10
DESCRIPTION OF THE PROCESS	11
THE STERILIZATION CYCLE	12
OPERATING INSTRUCTIONS	13
STERILIZATION	13
BETWEEN STERILIZATIONS	14
CLOSING DOWN FOR THE DAY	14
MALFUNCTIONS	15
FAULT CODES	15
PROCESS INTERRUPTED	16
SAFETY DEVICES	17
SAFETY CHECKING	17
MAINTENANCE	18
YEARLY MAINTENANCE SERVICE	19
DESIGN OF THE STERILIZER	20
COMPONENTS	20
SEARCHING FOR LEAKS	26
SERVICE PROGRAM	27
SERVICE PROGRAMME SCHEDULE	30
TECHNICAL DATA	31
TROUBLESHOOTING	32
GETINGE SKÄRHAMN’S POLICY:	34
FLOW CHART	35
DOOR CHART	36
ELECTRICAL DRAWING	36
CIRCUIT BOARD	37
SPARE PARTS LIST	38
COMPONENTS	40

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

3

5

DECLARATION OF CONFORMITY 1

Manufacturer 2

Name 3

Getinge Skärhamn AB

Adresse 4

Box19 S-47121 Skärhamn

Telefon 5

[phone]

Product 6

Machine reference 7

Sterilizer: GE 224c Vac / Citomat 164 Vac

Type number 13

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 10

Skärhamn 980714

Position of issuer 11

Managing director

Signatur of issuer 12

4

Translation of ”DECLARATION OF CONFORMITY”

	D		N		DK		P
1.	KONFORMITÄTS-	1.	ERKLÆRING VEDR.	1.	ERKLÆRING VEDR.	1. DECLARAÇÂ DE
	ERKLÄRUNG		ENHETLIGHET		ENSARTETHED		CONFORMIDADE
2.	Hersteller	2.	Produsent	2.	Producent	2.	Fabricante
3.	Name	3.	Navn	3.	Navn	3.	Nome
4.	Anschrift	4.	Adresse	4.	Adresse	4.	Mozada
5.	Telefon	5.	Telefon	5.	Telefon	5.	Telefone
6.	Erzeugnis	6.	Produkt	6.	Produkt	6.	Producto
7.	Beschreibung der Machine	7.	Type nummer	7.	Maskine ref.	7.	No. artigo
8.	Wir erklären in alleiniger	8.	Vi overtar ansvaret for at	8.	Vi erklaerer undere	8.	Declararnos sob nossa
	Verantwortung, dass dieses	dette produkt er i			almindeligt ansvar at dette		exclusiva
	Produkt mit den folgenden	overensstemmelse med			produkt er i		responsabilidade que este
	Normen oder normativen	følgende standarder eller			ovensstemmelse med		producto cumpre as
	Dokumenten übereinstimmt	standard-dokumenter			følgende normer eller		sequintas normas ou
9.	Gemass den Bestimmungen der	9.	I samsvar med		normative dokumenter		documentos normativos
	Richtlinien		bestemmelsene i direktivene	9.	I henhold til	9. De acordo com as
10. Datum		10. Dato			bestemmelserne i		disposiçoes das directivas
11. Titel des Ausstellers		11. Titel			direktiverne	10. Data
12. Unterschrift		12. Signatur		10. Dato		11. Cargo
				11. Titel		12.Assinatura
				12. Signatur
	NL-B		S		F
1.	VERKLARING VAN	1.	ÖVERENSKOMMELSED	1.	DÉCLARATION DE
	OVEREENKOMST		EKLARATION		CONFORMITÉ
2.	Fabricant	2.	Tillverkare	2.	Fabricant
3.	Naam	3.	Namn	3.	Nom
4.	Adres	4.	Adress	4.	Adresse
5.	Telf.nr.	5.	Telefon	5.	Telephone
6.	Produkt	6.	Produkt	6.	Produit
7.	Machine type	7.	Typbeteckning	7.	Ref de la machina
8.	Wij verklaren dat dit produkt	8.	Vi intygar och ansvarar för	8.	Nous déclarons sous notre
	voldoet aan de volgende		att denna produkt		propre responsabilité que ce
	normen of normatieve		överensstämmer med		produit est en conformité
	dokumenten		följande normer och		avec les normes ou
9.	Volgens de bepalingen van de		dokument.		documents normalisés
	richtlijnen	9.	Enligt bestämmelserna i	9.	Conformément aux termes
10. Datum van afgifte			direktiven		des réglementations
11. Functie		10. Datum		10. Date
12. Handteckning		11. Titel		11. Fonction
		12. Signatur		12. Cachet et signature
	FIN		I		E
1.	YHDENMUKAISUUSILMOI	1.	DICHIARAZIONE DI	1.	DECLARACIÓN DE
	TUS		CONFORMITA		CONFORMIDAD
2.	Valmistaja	2.	Produttore	2.	fabricante
3.	Nimi	3.	Nome	3.	Nombre
4.	Osoite	4.	Indirizzo	4.	Direccion
5.	Puh	5.	Telefono	5.	Telefono
6.	Tuote	6.	Prodotto	6.	Producto
7.	Viite	7.	Riterimento maccina	7.	Referncia de la machina
8.	Todistamme täten ja	8.	Assumendone la piena	8.	Declaramos bajo nuestra
	vastaamme yksin siitä, että		responsabilità, dichiariamo	sola responsabilidad que este
	tämä tuote en		che il prodotto é conforme	producto está en conformidad
	allalueltujenstandardien ja		alle sequenti normative ed	con las normas o documentos
	standardoimisasiakirjojenvaati		al relativi documenti.	normalizados siguientes
	musten mukainen.	9.	In base alle prescrizioni	9.	De acuerdo con las
9.	Seuraavien ohjeiden		delle directtive.		regulaciones
	määraysten mukaisesti	10. Data di emissione		10. Fecha
10. Päivämäärä		11. Qualifica del dichiarante		11. Cargo
11. Toimi yrityksesså		12. Firma del dicharante		12. Firma
12. Allerkirjoitus

5

INTRODUCTION

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

6

INSTALLATION

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.

7

•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 holders for bags (to improve drying results) - deionisation equipment - recorder / printer.

Contact your dealer for information.

8

STERILIZER CONTROLS

5	12

6

7

8

9 10

11

1

2

3

4

1Membrane key

•Program selection

2Membrane key

•Start

3Membrane key

•Reset (to reset faults)

4Membrane key

•Stop

5Display unit

•See section headed “Display unit”

6-9 Indicator lamps - yellow

• Program indication

10Indicating lamp - Green

•Indicates ”Processs Finished”

11Indicating lamp - Red

•Indicates “Error”

12Pressure gauge

•Shows the chamber pressure

9

15

18

19

14

17

13	16

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.

16Reset 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).

10

DISPLAY

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 program with “PROGR” Number of cycles run
	Select		0103
	134 oC		Textile		Current program. (Starting position between
					sterilization cycles)
3.					Prompt to close and lock the door
	Close the door.
					(Operator has pressed start with door open)
					During the process
4.					Current pressure - Current temp.- Minutes after start
	2,1	134	13
	Sterilization				Current sequence
					After completion of the process
5.					Current pressure - Current temp. Process time, min.
	0,0	100	15
	Finished				Process is complete but door has not been opened.
6.					See “Malfunctions”
	Fault codes

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.

11

DESCRIPTION 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			Process
		121Wrappe	134Flash	134 Wrapped	134 Textiles
		d
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		33	7	18	23
(approx)	minutes

Pressure

Time

Atmospheric pressure

Pre-treatment	Sterilizing					Post-treatment

Schematic pressure/time diagram for sterilizer with vacuum

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.

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.

12

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