Professional Documents
Culture Documents
Maintenance
Manual
FEDEGARI AUTOCLAVE
Vertical
FVA3_A1
Pabrik Kejayan
Maintenance
Step Maintenance Step Part
Task
1 Do Vacuum test and kept as data before Maintenance Vacuum Test
2
Before do the maintenance please Shut Off the supply Valve
Compressed Air, Chilled Water , Water, and Steam supply
Valve
3 Drain all pressureized in pipe Line Drain
4 Microswitch for LID/ Door Closing Check SMC0011F
5 Cooling Fan Checking SMC0013F
6 SAFETY VALVE FOR CHAMBER
CJ060365
Y001 CJ060526 SMC0021F
7 Replace Door Gasket PP600265 SMC0029F
8 Steam Line
KK000301
VP008 KS000025 SMC0040F
9 Compressed Air Supply
KK000301
SMC0040F
VP003 KS000025
R008 KK000255 SMC0027F
10 D.I WATER
KK000301
SMC0040F
VP009 KS000025
R004 KK000255 SMC0036F
11 GENERAL DRAIN
F008 CC150010 SMC0020F
KK000301
VP006 KS000025 SMC0040F
R002 KK000286 SMC0027F
KK000301
VP014 KS000025 SMC0040F
F009 CC120072 SMC0044F
KK000301
VP016 KS000025 SMC0040F
R010
CR016 KK000314 SMC0042F
R003 KK000255 SMC0027F
12 Calibration Temperature Sensor Calibration
13 Calibration Pressure Sensor Analog Sensor
14 Open All Valve Supply Valve
15 Vacuum test Vacuum Test
1. Choose menu Function List
5. Turn On valve that you wanna to open here, by touch each code
SCHEDA MANUTENZIONE SMC0011F
MAINTENANCE DATA SHEET Rev. 2- Page 1/4
APPARECCHIATURA
EQUIPMENT
FVA/A1 - FOB2-3 TS: MICRO INTERRUTTORE DI CHIUSURA COPERCHIO/PORTA
FVAIA1 -FOB2-3 TS: MICROSWITCH FOR LID/DOOR CLOSING
CD200063 MICROPRECISION SA
DESCRIZIONE APPARECCHIATURA
EQUIPMENT DESCRIPTION
Chiave a brugola:
Allen wrench:
OPERA2IONI
OPERATIONS
• II segnale luminoso dell'ingresso "2001" sara di colore verde con coperchio chiuso e di
colore nero con coperchio aperto.
The light signal of the "Z001" digital input will be green-coloured if the cover is closed and black
colored if the cover is open.
• Se si riscontrano problemi passare al punto 2, altrimenti riprendere con ii normale utilizzo
dello sterilizzatore.
In case of problems, proceed to point 2 otherwise re-statt the regular use of the sterilizer.
SCHEDA MANUTENZIONE SMC0011F
MAINTENANCE DATA SHEET Rev. 2- Page 3/4
• Svitare le viti che bloccano ii carter del coperchio (fig. 2a FVAIA1 - fig. 2b FOB2-3/TS).
Unscrew the screws blocking the sterilizer's cover casing (fig. 2a FVAIA1 - fig. 2b FOB2-3/TS).
• Togliere ii carter.
Remove the casing.
• Aprire ii portello anteriore e posteriore dello sterilizzatore (fig. 3a-3b FVAIA1 4a-4b FOB2-
3/TS).
Open the front and back panel of the sterilizer (fig. 3a-3b FVAIA1 and 4a-4b FOB2-3/TS).
• Svitare le viti che bloccano ii chiavistello al corpo dello sterilizzatore e rimuoverlo.
Unscrew the screws blocking the door latch to the sterilizer's body and remove it.
• Svitare le viti che bloccano ii supporto del microinterruttore di posizione al corpo dello
sterilizzatore e rimuoverlo.
Unscrew the screws blocking the microswitch support to the sterilizer's body and remove it.
• Svitare le viti che fissano ii microinterruttore al supporto.
Unscrew the screws blocking the microswitch to the support.
• Staccare i contatti elettrici della scheda di controllo (fig. 5), seguendo lo schema elettrico. II
e
micro collegato sul modulo Q07.K3P.xxxA nel caso degli sterilizzatori FVA/A1 e FOB2-3/TS
ad una porta, Mentre negli sterilizzatori FOB2-3 TS a doppia porta, ii micro della seconda
e
porta collegato ad un secondo modulo Q07.K3P.xxxB
Disconnect the control card (fig. 5) , following the electric diagram. The microswitch is connected to a
module Q07.K3P.xxxA on FVAIA1 and FOB2-3 TS sterilizers equipped with single door. On FOB2-3
TS sterilizers equipped with double door system, the microswitch of the second door is connected to
a second module Q07.K3P.xxxB
• Sostituire ii microinterruttore.
Replace the microswitch.
• Rimontare ii tutto e verificare che ii sistema funzioni correttamente come al punto 2.
Reassemble and check the right working as at the point 2.
SCHEDA MANUTENZIONE SMC0013F
MAINTENANCE DATA SHEET Rev. 2 - Page 1/6
APPARECCHIATURA
EQUIPMENT
FVAIA1: RAFFREDDAMENTO RAPIDO
FVAIA1: QUICK COOLING
I
REFERENCE CODE
I
MANUFACTURER
DESCRIZIONE APPARECCHIATURA
EQUIPMENT DESCRIPTION
Raffreddamento rapido
Quick cooling
Chiave esagonale:
Hex wrench:
Guanti:
Gloves:
Chiave a brugola:
Allen wrench:
Funzione
Function
Nome
Name
Data
Date
I Funzione
Function
Nome
Name
Data
Date
Redatto da: TQC M. A l toma r e 10- SEP- 2013 I Verificato e approvato da:
I Written by Venfled and approved by: QUA R.Boatti 10-SEP-2013
SCHEDA MANUTENZIONE SMC0013F
MAINTENANCE DATA SHEET Rev. 2 - Page 2/6
OPERAZIONI
OPERATIONS
ATTENZIONE!
WARNING!
La camera puo raggiungere temperature elevate. Prestare la massima attenzione per pericolo
scottature. Utilizzare mezzi di protezione idonei.
The chamber and the filter may reach high temperatures. Pay the utmost attention to burn risks. Use
the suitable protection means.
Fig.1
Fig. 2
• Rimuovere ii convogliatore.
Remove the conveyor.
SCHEDA MANUTENZIONE SMC0013F
MAINTENANCE DATA SHEET Rev. 2 - Page 3/6
. . '.
• Svitare i dadi di bloccaggio della
piastra di raffreddamento al
coperchio della camera dell'autoclave
(fig. 4).
Unscrew the nuts that lock the cooling
plate to the cover of the sterilizer's F ig. 4
chamber (fig. 4).
Fig. 6
Fig. 7
Fig. 8
Fig. 9
Fig.10 Fig. 11
• Svitare le viti di fissaggio della flangia fissa alla campana dei magneti interni (fig. 13).
Unscrew the screws that fasten the flange to the internal magnets' bell (fig. 13).
• Sfilare la flangia alla campana dei magneti interni (fig. 14).
Extract the flange of the internal magnets' bell (fig. 14).
• Estrarre ii cuscinetto superiore (fig. 15) e quello inferiore (fig. 16) dalle apposite flange e
quindi installare i nuovi cuscinetti.
Extract the upper (fig. 15) and lower (fig. 16) bearings from the corresponding flanges; therefore
install the new bearings.
APPARECCHIATURA
EQUIPMENT
FILTRO IN CAMERA
FILTER IN CHAMBER
OPERAZIONI
OPERATIONS
ATTENZIONE!
WARNING!
APPARECCHIATURA
I
EQUIPMENT
I
REFERENCE CODE
MANUFACTURER
I
CJ060365 CJ060504 CJ060377
CJ060366 CJ060505 CJ060378
CJ060376 CJ060476 COITECH
CJ060386 CJ060477
CJ060525 CJ060526
DESCRIZIONE APPARECCHIATURA
I
EQUIPMENT DESCRIPTION
I
TOOLS, INSTRUMENTS AND MATERIALS
Chiave esagonale: 13 mm
Guanti:
Hex wrench: 13 mm:
Gloves:
OPERAZIONI
OPERATIONS
ATTENZIONE!
WARNING!
Si sconsiglia di effettuare frequenti verifiche di apertura della valvola per controllare lo
stato di taratura. Le valvole di sicurezza installate sono prodotte da fornitori qualificati e
quindi corredate da un certificato di taratura conforme alle normative vigenti applicabili.
We do not recommend performing frequent opening checks on the valve to check its
calibration. The safety valves installed are supplied by qualified manufacturers and are
provided with calibration certificates in accordance with the regulations currently in force.
FEDEGARI consiglia di procedere alla revisione o alla sostituzione di tali dispositivi
ogni tre anni indipendentemente dalla frequenza di utilizzo e dalle condizioni di
esercizio. Ogni nuova fornitura di valvole di sicurezza di ricambio, viene corredata da un
nuovo certificato di taratura emesso dal fabbricante.
FEDEGARI recommends that you replace these devices every three years regardless of their
frequency of use and operating conditions. Each consignment of new safety valves for
replacement purposes is accompanied by a new calibration certificate issued by the
manufacturer.
La manomissione delle valvole di sicurezza pu6 causare gravi danni sia
all'apparecchiatura sia all'operatore. FEDEGARI declina ogni responsabilita derivante
da manomissione o incuria dei sistemi di sicurezza.
Tampering with the safety valves can cause serious damage to the equipment and injury to
the operator. FEDEGARI rejects all liability arising out of tampering or carelessness with the
safety systems.
Qualora vengano trattati materiali potenzialmente pericolosi per l'ambiente e/o per
l'uomo, si raccomanda di convogliare tutti i fluidi di scarico dello sterilizzatore in modo
opportuno. FEDEGARI declina ogni responsabilita derivante da un non corretto
convogliamento di suddetti fluidi
When processing materials potentially dangerous to the environment and/or to human beings,
we advise you to collect and dispose of all discharged fluid from the sterilizer in a correct and
appropriate manner. FEDEGARI rejects all liability consequent to incorrect disposal of the said
fluids.
ATTENZIONE!
WARNING!
In caso lo sterilizzatore operi ad altitudini dove la pressione ambientale risulti
sensibilmente diversa da 1 bar g, si richiede che tale informazione venga trasmessa a
FEDEGARI in sede di richiesta di una valvola di ricambio.
If the sterilizer is to be used at altitudes where the environmental pressure differs significantly
from 1 bar, we request you to inform FEDEGARI of this fact when requesting a replacement
valve.
• Questa prova e necessaria per controllare che tra otturatore e sede della valvola non ci siano
incollamenti o impedimenti che ne impediscono l'apertura.
This test is necessary to check there is no jamming or obstacles between the shutter and the valve
seat that could hinder opening.
ATTENZIONE!
WARNING!
• Aprire l'attacco rapido e sfilare la valvola di sicurezza; svitare poi ii tubo di sfiato dalla
valvola.
Open the clamp and remove the safety valve; unscrew the breather pipe from the safety valve.
• Sostituire l'anello di centraggio, 1'0-ring e la valvola di sicurezza; avvitare ii tubo di sfiato
sulla valvola.
Replace the guide ring, the 0-ring and the safety valve with new ones; screw the breather pipe on
the valve.
• Fissare ii tutto con l'attacco rapido.
Fix with a clamp.
• Rimontare i pannelli.
Reassemble the panels.
SCHEDA MANUTENZIONE SMC0027F
MAINTENANCE DATA SHEET Rev. 3 - Page 1/3
APPARECCHIATURA
EQUIPMENT
Valvole di ritegno singole e inserite in gruppi distributori
Check valves stand-alone and fitted on manifolds
FEDEGARIAUTOCLAVISPA
MONTAGGIO
MOUNTING
DN
su linea su pompa vuoto verticale
on line on vacuum pump vertical
GM350227
GM350241
112" GM350240 - GM350204
GM350255
DESCRIZIONE APPARECCHIATURA
EQUIPMENT DESCRIPTION
Valvola di ritegno a piattello
Shutter check valve
MANUTENZIONE FREQUENZA QUALIFICA MANUTENTORE
MAINTENANCE FREQUENCY OPERATOR'S QUALiFiCATION
1. Sostituzione piattello, O-ring, anello di annuale Operazioni effettuabili solamente da
centraggio e molla: yearly personale qualificato.
Shutter, O-ring, centring ring and Operation to be carried out by skilled
spring replacement: personnel only.
1. OPERAZIONI PRELIMINARI
PRELIMINARY OPERATIONS
ATTENZIONE!
WARNING!
Prima di eseguire la manutenzione e indispensabile accertarsi che non esista pressione
residua.
Before starting maintenance it is essential to make sure that there is no residual pressure.
La valvola puo raggiungere temperature elevate. Prestare la massima attenzione al
pericolo di scottature. Utilizzare mezzi di protezione idonei.
The valve may reach high temperatures. Pay the utmost attention to burn risks, use the
suitable protection means.
1.1 La seguente manutenzione deve essere eseguita a sterilizzatore spento. Assicurarsi che
l'alimentazione elettrica e le altre utenze siano interrotte.
Carry out the following maintenance while the sterilizer is switched off. Check that the electric power
supply and the other services are disconnected.
1.2 Se la valvola e singola e le condizioni dell'impianto lo permettono, rimuoverla e posizionarla su
un idoneo banco di lavoro. Nel caso in cui la valvola e inserita in un gruppo distributore o ii suo
smontaggio dalla linea risultasse difficoltoso, la manutenzione puo essere comunque eseguita
a bordo macchina.
If the valve is installed as a stand-alone component and, if allowed by the conditions of the system,
remove the valve and place it on a suitable workbench. If the valve is part of a manifold or if it is
difficult to remove from the line, maintenance can be performed with the valve installed on the
machine.
2. SOSTITUZIONE PIATTELLO, O-RING E MOLLA VALVOLE
SHUTTER, 0-RING AND SPRING VALVES REPLACEMENT
2.1 Per la sostituzione fare riferimento alla seguente tabella, indicante i kit di ricambio.
For the replacement refer to the following table, indicating spare parts kit.
KK000297 GM350218
2.2 Separare la flangia (1) dalla flangia (2) utilizzando due chiavi esagonali (Fig. 1).
Using two hex wrenches, separate the flange (1) from the flange (2) (Fig. 1).
2.3 Togliere 1'O-ring (3) e ii fondello (4) (Fig. 1).
Remove the 0-ring (3) and the bottom (4) (Fig. 1).
2.4 Sfilare ii piattello (5) e la molla - se presente - (6) dalla flangia (1) (Fig. 1).
Remove the shutter (5) and the spring- if included - (6) from the flange (1) (Fig. 1).
2.5 Togliere gli O-ring (7) dal piattello (5) (Fig. 1).
Remove the 0-rings (7) from the shutter (5) (Fig. 1).
2.6 Pulire tutte le parti smontate e verificare l'assenza di rotture o danneggiamenti vari sulle parti
costituenti l'assieme.
Clean all the disassembled parts and check for breakage or damage to the parts that form the
assembly.
SCHEDA MANUTENZIONE SMC0027F
MAINTENANCE DATA SHEET Rev. 3 - Page 3/3
2.7 Sostituire ii piattello (5), gli O-ring (3-7) e la molla -se presente- (6) (Fig. 1).
Replace the shutter (5), the O-rings (3-7) and the spring-if included- (6) (Fig. 1).
2.8 Rimontare la valvola eseguendo in senso inverso le operazioni descritte nei precedenti punti.
Reassemble the valve by performing in reverse the operations described above.
APPARECCHIATURA
EQUIPMENT
GUARNIZIONE COPERCHIO FVAIA1 FOB2-3ITS
COVER GASKET FVAIA1 FOB2-3/TS
FVAIA1 FOB2-3/TS
I
TOOLS, INSTRUMENTS AND MATERIALS
Chiave a brugola:
Allen wrench:
1. CONTROLLO GUARNIZIONE
GASKET CHECKING
• Ruotare ii coperchio in posizione di apertura in caso di autoclave FVAIA1, aprire la porta
completamente in caso di autoclave FOB2-3/TS (fig. 1).
Rotate the cover at the opening position in case of FVAlA1 autoclave, open completely the door in
case of FOB2-3/TS autoclave (fig. 1).
• Controllare la forma e la consistenza della guarnizione (fig. 2): non deve presentare rotture,
screpolature o risultare secca. Controllare la perfetta tenuta della guarnizione.
Check the shape and the consistency of the gasket (fig. 2): it has not to be dry or have breaking or
crazing. Check the gasket's seal.
• Controllare che non ci siano particelle metalliche o di altro materiale (vetro, etc.) penetrate
nella massa della guarnizione.
Check there are not metal or other material particles (glass, etc.) in the gasket's mass.
• Controllare che non si manifestino fenomeni di incollaggio della guarnizione (dovuti per
esempio ad uso di qualche agente chimico per la pulizia della camera).
Check there are not cases of gasket's jamming (caused by chemical agents used to clean the
chamber).
• Se i risultati delle precedenti verifiche sono negativi o incerti passare al punto 2.
If the results of the check are negative or doubtful, proceed to point 2.
2. SOSTITUZIONE GUARNIZIONE
GASKET REPLACEMENT
• Aprire ii pannello frontale in caso di autoclave FVA/A1, aprire ii pannello laterale destro in
caso di autoclave FOB2-3/TS (fig. 3).
Open the front panel in case of FVAIA1 sterilizer, open the right side panel in case of FOB2-3/TS
autoclave (fig. 3).
• Mettere in pressione la guarnizione agendo sul comando manuale dell'elettrovalvola E012
(fig. 3) assicurandosi che la dicitura riportata sia la suddetta. In caso di FOB2-3/TS a due
porte, effettuare la medesima operazione sull'elettrovalvola E012.2 per la seconda porta.
Get up steam the gasket operating with the hand drive of the E012 electro-valve (fig. 3) checking the
exact wording. In case of double door FOB2-3/TS autoclave, perform the same operation on the
E012.2 electro valve for the second door.
• L'aria compressa presente nei condotti e nella sede della guarnizione espellera la guarnizione
dalla sua sede.
The compressed air in the piping and in the gasket housing will discharge the gasket from its
housing.
• Agire sul comando manuale dell'elettrovalvola E013 per interrompere ii flusso dell'aria alla
guarnizione (fig. 3) assicurandosi che la dicitura riportata sia la suddetta. In caso di FOB2-
3/TS a due porte, effettuare la medesima operazione sull'elettrovalvola E013.2 per la seconda
porta.
Operate with the hand drive of the E013 electro-valve to stop the air flow to the gasket (fig. 3); check
the exact wording. In case of double door FOB2-3/TS autoclave, perform the same operation on the
E013.2 electro valve for the second door.
Fig. 1 Localizzazione Manifold FVA/A1 e FOB2-3/TS / Manifold localization FVAIA1 and FOB2-3/TS
• lnserire la nuova guarnizione nella propria sede avendo cura di non danneggiarne i bordi. La
guarnizione e stampata in un unico pezzo per cui rispecchia fedelmente ii disegno della sede
(fig. 4).
Settle the new gasket in its housing without damaging the borders. The gasket is printed in one
piece reflecting exactly the housing design (fig. 4).
(ElFEDEGARI®
(SUI SSE)®&
SCHEDA MANUTENZIONE
MAINTENANCE DATA SHEET
SMC0029F
Rev. 2 - Page 4/4
A - Espulsione
A - Ejection
fig. 4
$CHEDA MANUTENZIONE SMC0036F
MAINTENANCE DATA SHEET Rev. 2 - Page 1/3
APPARECCHIATURA
I Gruppo
EQUIPMENT
valvola di ritegnolvalvola pneumatica
Check valve/pneumatic valve assembly
DESCRIZIONE APPARECCHIATURA
I Valvola
EQUIPMENT DESCRIPTION
di ritegno a piattello - Valvola a membrana ON-OFF
Shutter check valve - Diaphragm ON-OFF valve
MANUTENZIONE
FREQUENZA I QUALIFICA MANUTENTORE
I MAINTENANCE FREQUENCY OPERATOR'S QUALiFiCATION
• Chiave esagonale: 27 mm
Hex wrench
• Chiave a pipa: 13 mm
Pipe wrench
1. OPERAZIONI PRELIMINARI
PRELIMINARY OPERATIONS
ATTENZIONE!
WARNING!
Prima di eseguire la manutenzione e indispensabile accertarsi che non esista pressione
residua.
Before starting maintenance it is essential to make sure that there is no residual pressure.
II gruppo puo raggiungere temperature elevate. Prestare la massima attenzione al pericolo
di scottature. Utilizzare mezzi di protezione idonei.
The assembly may reach high temperatures. Pay the utmost attention to bum risks, use the
suitable protection means.
1.1 La seguente manutenzione deve essere eseguita a sterilizzatore spento. Assicurarsi che
l'alimentazione elettrica e le altre utenze siano interrotte.
Carry out the following maintenance while the sterilizer is switched off. Check that the electric power
supply and the other services are disconnected.
2.1 Togliere ii morsetto di fissaggio (17), l'anello di centraggio (15) e I'O-ring (16) (Fig. 1 e 2).
Remove the fixing clamp (17),centering ring (15)and the O-ring (16) (Fig. 1 and 2).
2.2 Separare la flangia (4) dal corpo (1) utilizzando una chiave esagonale (Fig. 1 and 2).
Using an hex wrench, separate the flange (4) from the body (1)(Fig. 1 and 2).
2.3 Sfilare ii piattello (6) e la molla (5) dal corpo (1) (Fig. 1 e 2).
Remove the shutter (6) and the spring (5) from the body (1) (Fig. 1 and 2).
2.5 Pulire tutte le parti smontate e verificare l'assenza di rotture o danneggiamenti vari sulle parti
costituenti l'assieme.
Clean all the disassembled parts and check for breakage or damage to the parts that form the
assembly.
2.6 Sostituire ii piattello (6), l'O-ring (3) e la molla (5) (Fig. 1 e 2).
Replace the shutter (6), the O-ring (3) and the spring (5) (Fig. 1 and 2).
2.7 Rimontare la valvola eseguendo in senso inverso le operazioni descritte nei precedenti punti.
Reassemble the valve by performing in reverse the operations described above.
Figura 2 - GM250541
Figure 2- GM250541
SCHEDA MANUTENZIONE SMC0040F
MAINTENANCE DATA SHEET Rev. 2 - Page 1/5
APPARECCHIATURA
EQUIPMENT
Valvola a membrana ON-OFF singole e inserite in gruppi distributori
Diaphragm ON-OFF stand-alone valves and fitted on manifolds
Codici e dimensioni
Codes and dimensions
GM200563
DN10 FEDEGARI (SUISSE) SA
GM200514
DN16 GM200561
DN22 GM200568
DESCRIZIONE APPARECCHIATURA
EQUIPMENT DESCRIPTION
• Funzione: ON-OFF, normalmente chiusa
Function: normally closed
• Pressione max. fluido: 6 bar
Line max pressure:
• Temperatura max.: 160°C
Max temperature:
Dimensione nominale Coefficiente di portata
• Pressione max. di pilotaggio: 7 bar Nominal size Flow coefficient
Max control pressure [mm] [I/min]
• Pressione min. di pilotaggio: 4 bar DN10 Kv 33.5
Min control pressure DN16 Kv 100
• Corpo: AISl316L DN22 Kv 190
Body
• Membrana: PTFE
Diaphragm
1. OPERAZIONI PRELIMINARI
PRELIMINARY OPERATIONS
ATTENZIONE!
WARNING!
Prima di eseguire la manutenzione e indispensabile accertarsi che non esista pressione
residua. La valvola pu6 raggiungere temperature elevate. Prestare la massima
attenzione al pericolo di scottature. Utilizzare mezzi di protezione idonei.
Before starting maintenance it is essential to make sure there is no residual pressure. The
valve may reach high temperatures. Pay the utmost attention to burn risks, use the suitable
protection means.
1.1 La seguente manutenzione deve essere eseguita a sterilizzatore spento. Assicurarsi che
l'alimentazione elettrica e le altre utenze siano interrotte. L'aria compressa e l'unica utenza
che deve rimanere attiva per consentire le operazioni di smontaggio e rimontaggio della
valvola.
Carry out the following maintenance while the sterilizer is switched off. Check that the electric
power supply and the other services are disconnected. Compressed air is the only service that
needs to remain active in order to allow valve disassembly and reassembly.
1.2 Se la valvola e singola e le condizioni dell'impianto lo permettono, rimuoverla e
posizionarla su un idoneo banco di lavoro. Nel caso in cui la valvola e inserita in un gruppo
distributore o ii suo smontaggio dalla linea risultasse difficoltoso, la manutenzione pu6
essere comunque eseguita a bordo macchina.
If the valve is installed as a stand-alone component and, if allowed by the conditions of the
system, remove the valve and place it on a suitable workbench. If the valve is part of a manifold
or if it is difficult to remove from the line, maintenance can be performed with the valve installed
on the machine.
2. SOSTITUZIONE MEMBRANA E 0-RING
VALVE DIAPHRAGM AND O-RING REPLACEMENT
2.1 KIT da ordinare per eseguire l'operazione I KIT to purchase in order to perform the operation:
DN10 GM200563 GM200514 Kit: KK000301
DN16 GM200561 Kit: KK000304
DN22 GM200568 Kit: KK000306
2.2 lmmettere aria compressa nell'attuatore attivando manualmente la relativa elettrovalvola
posizionata sul quadro elettrico (Fig. 1).
Feed compressed air into the actuator by activating manually the corresponding solenoid valve
located on the electric panel board (Fig. 1).
SCHEDA MANUTENZIONE SMC0040F
MAINTENANCE DATA SHEET Rev. 2 - Page 3/5
2.3 Svitare con chiave a settore la ghiera (1) (Fig. 2) e separare la valvola dal corpo inferiore o
dal gruppo distributore.
Using the pin wrench, unscrew the ring (1) (Fig. 2) and separate the valve from the lower body or
from the manifold.
ATTENZIONE!
WARNING!
Aprire la valvola utilizzando solamente la ghiera (1) (Fig. 2).Non ruotare ii corpo
inferiore e quello superiore per aprire la valvola; in questo modo si evita ii possibile
danneggiamento dell'otturatore.
Open the valve by using only the ring (1) (Fig. 2).Do not tum the upper and lower body to open
the valve. This operation avoids the possible diaphragm damage.
2.7 Pulire tutte le parti smontate e verificare l'assenza di rotture o danneggiamenti vari sulle
parti costituenti l'assieme.
Clean all the disassembled parts and check for breakage or damage to the parts forming the
assembly.
2.8 Sostituire la membrana (2) e I'O-ring (3) (Fig. 3).
Replace the diaphragm (2) and the O-ring (3) (Fig. 3).
2.9 Rimontare la valvola eseguendo in senso inverso le operazioni descritte nei precedenti
punti.
Reassemble the valve by performing the operations described above in reverse order.
ATTENZIONE!
WARNING!
Aprire la valvola utilizzando solamente la ghiera (1) (Fig. 2).Non ruotare ii corpo
inferiore e quello superiore per aprire la valvola; in questo modo si evita ii possibile
danneggiamento dell'otturatore.
Open the valve by using only the ring (1) (Fig. 2).Do not turn theupper andlower body to open
the valve. This operation avoids the possible diaphragm damage.
APPARECCHIATURA
EQUIPMENT
Rubinetto a spillo conico
Conical needle valve
• Chiave a brugola: 5 mm
Allen wrench
1. OPERAZIONI PRELIMINARI
PRELIMINARY OPERATIONS
ATTENZIONE!
WARNING!
e
Prima di eseguire la manutenzione indispensabile accertarsi che non esista pressione
residua.
Before sta,ting maintenance it is essential to make sure that there is no residual pressure.
II gruppo puo raggiungere temperature elevate. Prestare la massima attenzione al
pericolo di scottature. Utilizzare mezzi di protezione idonei.
The assembly may reach high temperatures. Pay the utmost attention to bum risks, use the
suitable protection means.
1.1 La seguente manutenzione deve essere eseguita a sterilizzatore spento. Assicurarsi che
l'alimentazione elettrica e le altre utenze siano interrotte.
Carry out the following maintenance procedure while the sterilizer is switched off. Check the electric
power supply and the other services are disconnected.
2. CODICE GM150186 SOSTITUZIONE O-RINGS (KIT RICAMBIO O-RING: KK000314)
CODE GM150186 O-RING REPLACEMENT (O-RINGS SPARE KIT : KK000314)
2.1 Svitare ii dado (1) (Fig. 1).
Unscrew the nut (1) (Fig. 1).
2.2 Svitare la ghiera di tenuta (2) e togliere O-ring (4) (Fig. 1).
Unscrew the ring nut (2) and remove the O-ring (4) (Fig. 1).
2.3 Separare l'otturatore (3) dal corpo (5) (Fig. 1).
Separate the shutter (3) from the body (5) (Fig. 1).
2.4 Togliere 1'O-ring (6) dall'otturatore (3) (Fig. 1).
Remove the O-ring (6) from the shutter (3) (Fig. 1).
2.5 Pulire tutte le parti smontate e verificare l'assenza di rotture o danneggiamenti vari sulle parti
costituenti l'assieme.
Clean all the disassembled parts and check for breakage or damage to the parts that form the
assembly.
2.6 Sostituire gli O-ring (4-6) (Fig. 1).
Replace the O-rings (4-6)) (Fig. 1).
2.7 Rimontare ii rubinetto eseguendo in senso inverso le operazioni descritte nei precedenti
punti.
Reassemble the valve by performing the operations described above in reverse order.
APPARECCHIATURA
EQUIPMENT
FILTRO PER ARIA STERILE CON HOUSING IN 31SL
STERILE AIR FILTER WITH 316L HOUSING
Guanti:
Gloves:
OPERAZIONI
OPERATIONS
1. OPERAZIONI PRELIMINARI
PRELIMINARY OPERATIONS
1.1 La seguente manutenzione deve essere eseguita a sterilizzatore spento. Assicurarsi che
l'alimentazione elettrica e le altre utenze siano interrotte.
Carry out the following maintenance procedure while the sterilizer is switched off. Check the electric
power supply and the other services are disconnected.
ATTENZIONE!
WARNING!
e
Prima di eseguire la manutenzione indispensabile accertarsi che non esista pressione
residua nel contenitore del filtro. Provvedere allo scarico dell'eventuale pressione
residua aprendo i rubinetti a monte e a valle del filtro.
Before starting maintenance it is essential to make sure that there is no residual pressure
inside the air filter housing. Release the possible residual pressure by opening the manual
valves upstream and downstream the filter.
ATTENZIONE!
WARNING!
II contenitore del filtro pu6 raggiungere temperature elevate. Prestare la massima
attenzione al pericolo di scottature. Utilizzare mezzi di protezione idonei.
The filter housing may reach high temperatures . Pay the utmost attention to burn risks, use the
suitable protection means.
2.1 Allentare, con cautela, ii morsetto di fissaggio (3) del contenitore filtro e rimuoverlo (Fig. 1).
Release carefully the fixing clamp (3) of the filter housing and remove it (Fig. 1).
2.3 Rimuovere 1'0-ring di tenuta (6), pulire accuratamente la sua sede e sostituirlo (Fig. 1).
Remove the sealing O-ring (6), clean carefully its slot and replace it (Fig. 1).
2.4 Estrarre la cartuccia filtrante (7) dalla propria sede e sostituirla con una nuova (Fig. 1).
Extract the filter cartridge (7) from its slot and replace it with a new one (Fig. 1).
2.5 Rimontare tutte le parti eseguendo inversamente le procedure descritte nei punti precedenti.
Reassemble all parts following the above mentioned procedures in reverse order.
1. Choose menu Function List
The purpose of this paragraph is to describe the operating procedures for correctly performing the
calibration of analogical signals. In our view, it is advisable for users to have their own internal operating
procedures, and this document can be useful when drafting or reviewing such procedures.
One key aspect of the sterilization process is the level of accuracy with which the sterilizer is able to control
the temperature. As a part of this control, the ability to read process variables (temperature and pressure)
accurately is obviously particularly important. In order to better qualify the sterilizers that it manufactures,
FEDEGARI has always devoted particular attention to the choice of all the components of measurement
chains (and in particular of sensors).
Analog signal measurement chains generate errors anyway and therefore are subject to being inaccurate
(i.e., to having accuracy limits); systematic errors, however, can be corrected by implementing suitable
procedures for adjusting the signal or the reading. The process controllers more recently installed on
FEDEGARI sterilizers are equipped with suitable software operations that allow to correct the reading
without acting on hardware components (such as trimmers).
Clearly, in order to maintain the accuracy characteristics that distinguish FEDEGARI sterilizers, it is
necessary to perform periodically (typically once a year or once every six months) a regulation and
calibration (i.e. a partial correction and certification of errors).
Correct regulation and calibration of analog signals require suitable procedures and instruments and in
particular reference instruments that are periodically certified with reference to first-line national standards.
The precision (or more exactly accuracy) characteristics of the instruments used for regulation and
calibration are also crucially important in maintaining the levels of accuracy that FEDEGARI sterilizers are
required to have.
For years, FEDEGARI has had procedures and instruments suitable to maintain the accuracy of the control
of the sterilization process within the limits of ±0.5°C (i.e., as required by the FDA for the sterilization of
LVP), even when applying the strict 1:4 Uncertainty Ratio (the ratio appropriate according to Brunner). It is
therefore evident that in order to maintain the required accuracy, the individuals who perform periodic
regulation and calibration services on sterilizers manufactured by FEDEGARI too should be equipped with
instruments and procedures capable of ensuring the same performance. Based on these criteria, the
following is deemed adequate:
1) For temperature measurements:
Reference instruments (sensor + reader) with an accuracy equal to or higher than:
±0.5°C / 4 / 4 ±0.03°C
with certification renewed annually by an EA-accredited laboratory (SIT or equivalent body) in the range
from 0 to 250°C and with a typical measurement uncertainty of ±0.03°C or higher.
Thermostatic baths and methods suitable to maintain the probes in an environment with temperature
uniformity equal to ±0.05°C with good stability at set point (indicatively, ±0.005°C per hour).
with certification renewed annually by an EA-accredited laboratory (ACCREDIA or equivalent body) in the
range from 0.1 to 7 bar, with rising and falling calibration, with a maximum uncertainty of measurements of
±0.001 bar or higher. Calibration of the reference instrument at the following points is recommended: 0.1,
0.4, 0.8, 1.0, 1.2, 1.5, 2.0, 2.5, 3.0, 3.5, 5.0, 7.0 bar.
Preliminary operations
After selecting the reference instruments based on the criteria described in chapter 1 of the present
document and on the operative limits of the sterilizer, the person in charge of the calibration shall verify the
following:
the reference instrument shall be able to operate (operative range) at values > than the defined HIGH
POINT and at values < than the defined LOW POINT,
the reference instrument shall be calibrated (we recommend to define the frequency of calibration
based on the frequency of use, to perform the calibration no later than one year after the last calibration
and always to ask the laboratory for the "as found" certification besides the calibration certificate).
The person in charge of the calibration shall define the measurement points to be used as reference. We
suggest the following values:
LOW POINT suggested equal to 100°C,
MEDIUM POINT suggested equal to 121
°C HIGH POINT suggested equal to
150°C.
After positioning the reference probe (Intelligent probe IRTD) and the probe belonging to the measurement
chain to calibrate inside a thermostatic bath (dry well – portable temperature reference), the person in
charge shall verify the signal stability, positively evaluating variations not higher then 0.2°C in three minutes.
The temperature values measured by the reference instrument shall be indicated in the specific box
contained in the process controller section dedicated to calibration (see subsequent paragraphs). The
comparison between the values read by the measurement chain and the values indicated by the reading of
the reference instrument allow the process controller to take these variations into account in the operative
management of the sterilizer. The End-User has to define in its calibration procedures the acceptance
criteria to be applied in the evaluation of the difference between a value read by the measurement chain
and a value that can be referred to a reference instrument (whose characteristics are specified in the
present document).
In case these acceptance criteria are not satisfied, one item of the measurement chain shall be replaced
and the calibration activities shall be repeated starting from the modalities described in chapter 3 of the
present document.
The calibration of temperature PT100 probes has to be done by following this steps:
From the main MONITOR menu press the icon related to SYSTEM menu.
If the SYSTEM icon is hidden press the shown icon in order to show it.
Press the shown icon in order to access the ANALOGUE SIGNALS
menu.
For every PT100 probe, insert in the field “L” the value read by the
analogue input and in the field “C” the calibrated reference value of the
LOW point (suggested 100.0 °C).
For every PT100 probe, insert in the field “L” the value read by the
analogue input and in the field “C” the calibrated reference value of the
MEDIUM point (suggested 121.0 °C).
For every PT100 probe, insert in the field “L” the value read by the
analogue input and in the field “C” the calibrated reference value of the
HIGH point (suggested 150.0 °C).
The person in charge of calibration shall define the measurement points to be used as reference. We
suggest the following values:
LOW POINT, the best vacuum value obtainable – for instance about 0.060 bar (if KX20 Vacuum pump is
present) - or equal to atmospheric pressure;
MEDIUM POINT, an average pressure value correspondent to 2.100 bar.
HIGH POINT, less then 0,2 bar with respect to the set point of the installed safety valve - for instance
4.800 for standard autoclaves and 5.200 for HT autoclaves.
In order to reduce the thermal shift typical of the pressure transducers, before performing the calibration the
instrument installed on the autoclave shall be evenly heated performing at least one sterilization cycle. At
the end of this adjustment phase it will be possible to connect the pressure calibrator to the autoclave by
means of the specific flange. Chamber pressurization shall be performed using air as working fluid in order
not to damage the reference instrument; to obtain the maximum vacuum value it will be necessary to
regulate the specific activations manually. At this point, the person in charge shall verify the stability of the
signal, positively evaluating variations not higher than 5 mbar in one minute. The pressure values measured
by the reference instrument shall be indicated in the specific box contained in the process controller section
dedicated to calibration (see subsequent paragraphs). The comparison between the values read by the
measurement chain and the values from the reading of the reference instrument allow the process
controller to take these variations into account in the operative management of the sterilizer.
The End-User has to define in its calibration procedures the acceptance criteria to be applied in the
evaluation of the difference between a value read by the measurement chain and a value that can be
referred to a reference instrument (whose characteristics are specified in this section). In case these
acceptance criteria are not satisfied, one item of the measurement chain shall be replaced and the
calibration activities shall be repeated. Regarding the pressure calibration page, it is there possible to
activate the related inputs in order to depressurize and pressurize the chamber and set the three point
calibrations.
Insert in the field “L” the value read by the pressure transducer and in the field
“C” the value of atmospheric pressure – detected with open door – as LOW
point.
Press the shown icon to automatically activate the vacuum pump and
depressurize the chamber at a 0.060 mBar value. During the depressurization, if
the icon is pressed, the vacuum pump stops at the value reached in that
moment.
Insert in the field “L” the value read by the pressure transducer and in the field
“C” the pressure value reached as LOW point.
Press the shown icon in order to bring back the sterilizer to atmospheric value.
Press the shown icon in order to pressurize the chamber up to for instance
2.100 bar value.
Press the shown icon in order to close the air in chamber circuit, intercepted by
valve VP003. By pressing this icon a second time, the atmospheric balance will
be activated and autoclave baric status will be restored.
Insert in the field “L” the value read by the pressure transducer and in the field
“C” the pressure value reached as MEDIUM point.
Press the shown icon in order to close the air in chamber circuit, intercepted by
valve VP003. By pressing this icon a second time, the atmospheric balance will
be activated and autoclave baric status will be restored.
Insert in the field “L” the value read by the pressure transducer and in the field
“C” the pressure value reached as MEDIUM point.
Press the shown icon in order to pressurize the chamber up to for instance
4.800 bar value.
Insert in the field “L” the value read by the pressure transducer and in the field
“C” the pressure value reached as HIGH point.
Press the shown icon in order to close the air in chamber circuit, intercepted by
valve VP003. By pressing this icon a second time, the atmospheric balance will
be activated and autoclave baric status will be restored.
Insert in the field “L” the value read by the pressure transducer and in the
field “C” the pressure value reached as HIGH point.
NOTE
The icons shown in the previous points have a “toggle” function. In order to be activated the
icons need to be pressed one time, and need to be pressed a second time to be deactivated.
The contents of this paragraph can be applied when new sensors installed on the sterilizer are to be
calibrated in order to substitute those provided by the manufacturer. For this purpose, FEDEGARI
recommends the use of original spare parts, in particular the PT100 probes and the pressure transducers.
The technical manual provided with the sterilizer explains how to order the spare parts correctly. Before
starting the calibration of the entire measurement chain, a preliminary check of the new sensor shall be
performed in order to evaluate its compliance. The activities are the same as those reported in the present
document, with the difference that, if the following acceptance criteria are not satisfied, no value will be
indicated in the process controller as the sensor undergoing verification shall be rejected because it is not
considered sufficiently accurate. The acceptance criteria for temperature relevant to the preliminary check
of a new sensor before to perform the calibration are:
The acceptance criteria for pressure relevant to the preliminary check of a new sensor before to perform the
calibration are:
±0.025 bar at the calibration low, medium and high point
1.5. ANNEX
NOTE
The maintenance data sheets are referred to the P&ID list LP040001F included in the
Section 3 of the present Technical Manual.