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CISA S.r.l. - Manual of Use and Maintenance - Version 4.

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STEAM STERILIZING AUTOCLAVES

MANUAL OF USE AND MAINTENENCE

CISA S.r.l.
Via Pontina Km.28
00040 POMEZIA (RM) - ITALIA -

Tel. +39 (06) 91 14 37.1


Fax +39 (06) 91 07 565
Office Assistance. +39 (06) 91 22 288

Autoclaves CISA Total Pages n.120 + Encloseds


CISA S.r.l. - Manuale d’Uso e Manutenzione - Versione 4.0/00

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CONTENTS

NOTICES FOR SAFETY 5

PARAGRAPH 1.0
GENERAL INFORMATION 19
1.1 WARRANTY 19
1.2 TYPES OF LOAD AND PACKING 20
1.3 WASHING AND PACKING OF MATERIAL BEFORE THE STERILIZATION 21
1.4 STERILIZATION CYCLES 25
1.5 SAFETY SYSTEMS 40
1.6 SAFETY SYSTEMS – SET AND FUNCTIONALITY 41
1.7 OPERATOR CODES 43
1.8 ALARMS 44

PARAGRAPH 2.0
MANAGEMENT OF THE AUTOCLAVE 47
2.1 PRELIMINARY OPERATIONS 47
2.2 STARTING OF THE AUTOCLAVE 47
2.3 MAIN MENU 48
2.4 PROCEDURE STARTING OF THE CYCLE 48
2.5 CHOICE OF THE TYPE OF PACKING 58
2.6 INSERTION LOT CODE 51
2.7 INSERTION OPERATOR CODE 51
2.8 CONFIRMATION STARTING OF THE CYCLE 52
2.9 AUTOMATIC DRAIN OF THE GENERATOR 53
2.10 VERIFICATION CONDITIONS TO PROCEED TO THE STARTING OF A CYCLE 54
2.11 PHASE IN COURSE 55
2.12 MANUAL WORKING 56
2.13 CANCELLATION OF THE CYCLE 56
2.14 SUBMENU OF SELECTION 57
2.15 PAGE SET-POINT 57
2.16 PAGE VALUES 58
2.17 PAGE DIAGRAM 58
2.18 PAGE ALARMS 59
2.19 END OF THE CYCLE 60
2.20 PRINTS 62

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2.21 OPERATION OF LOAD/UNLOAD AUTOCLAVE 65


2.22 LABEL REPRINTING 72

PARAGRAPH 3.0
TECHNICAL FUNCTIONS 73
3.1 PROCEDURE FOR THE MANAGEMENT OF TECHNICAL PARAMETERS 73
3.2 ACCESS TO THE MENUS 73
3.3 CHANGE DATE AND TIME 74
3.4 MODIFICATION OF THE HEATING SYSTEM 75
3.5 MODIFICATION OF THE PARAMETERS IN THE OPEN CYCLES 75
3.6 MODIFICATION OF THE PARAMETERS 76
3.7 MODIFICATION OF THE PARAMETERS RELATIVE TO THE MAINTENANCE 82
3.8 MENU PARAMETERS 1 83
3.9 MENU PARAMETERSI 2 83
3.10 MODIFICATION OF THE STANDARD CYCLES 86
3.10.1 STANDARD CYCLE CONFIGURATION 86
3.11 CALIBRATION 87

PARAGRAPH 4.0
MAINTENANCE 93
4.1 GENERAL INFORMATION ABOUT MAINTENANCE 93
4.2 PROGRAMMED MAINTENANCE 93
4.3 FURTHER USEFUL ADVISES OF MAINTENANCE 95
4.4 CLEANING AUTOCLAVE 95
4.5 REPLACEMENT OR CLEANING DOOR’S GASKET 96
4.6 REPLACEMENT BACTERIOLOGICAL AIR FILTER 96
4.7 REPLACEMENT STEAM FILTER 97
4.8 CLEANING FILTER DRAIN CHAMBER 97
4.9 CLEANING FILTER COMPRESSED AIR 97
4.10 REPLACEMENT FUSES 98
4.11 RESET THERMICS 99
4.12 REPLACEMENT BATTERIES 100
4.13 PRINTER 101
4.13.1 REPLACEMENT THE PAPER ROLL 101
4.13.2 REPLACEMENT THE INKED ROLL 101
4.14 LIST HINT OF QUICK REPAIRING 102

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PARAGRAPH 5.0
ACCESSORIES 111
5.1 MAGNETIC WATER SOFTENER 111
5.2 ELECTRIC AIR COMPRESSOR 111
5.3 GRAPHIC RECORDER 112
5.3.1 INSTALLATION OF THE PAPER 112
5.3.2 UNROLLING OF THE PAPER ON THE FRONT 112
5.3.3 ASSEMBLING OF THE PENS 112
5.3.4 PRESSURE OF THE PEN 113
5.3.5 SETTLEMENT OF THE WRITING POINT 113
5.3.6 CONTROL OF THE SCALES, INDICATORS AND CAPILLARIES PENS 113
5.3.7 IINITIAL LUBRICATION 113
5.4 COOLING DRAINS DEVICE 113
5.5 MODULAR BASKET 113
5.6 CONTAINERS 113
5.7 TRAYS 113

PARAGRAPH 6.0
STERILIZATION MANAGEMENT 114
6.1 FORMALDHEYDE USE 114
6.2 DESCRIPTION OF THE STANDARD FORMALDHEYDE CYCLE 115

APPENDIXES 121

APPENDIX A
IDENTIFICATION CARD OF THE AUTOCLAVE

APPENDIX B
IDENTIFICATION CARD OF THE GENERATOR

APPENDIX C
FEATURES OF THE ELECTRIC BOARD

APPENDIX D
IDENTIFICATION CARD OF THE VACUUM PUMP

APPENDIX E
IDENTIFICATION CARD OF WATER PUMP

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PICTURES
PIC. 1 – AUTOCLAVES SERIE CISA 3000-3600 PAG.11

PIC. 2 – AUTOCLAVES SERIE CISA 400-420 PAG.12

PIC. 3 – AUTOCLAVE SERIE CISA 640 PAG.13

PIC. 4 – AUTOCLAVE SERIE CISA 1000 PAG.14

PIC. 5 – AUTOCLAVE SERIE CISA 1400 PAG.15

PIC. 6 – AUTOCLAVE SERIE CISA 1350 PAG.16

PIC. 7 – LOAD SIDE CONTROL PANEL LEGENDA PAG.17

PIC. 8 – UNLOADING SIDE CONTROL PANEL LEGENDA PAG.18

PIC. 9 – TABLE OF REFEREMENT SATURATED STEAM TEMPERATURE / PRESSURE PAG.39

PIC. 10 – TABLE OPERATOR CODE PAG.42

PIC. 11 – INTERNAL/EXTERNAL TROLLEY CISA 640 PAG.67

PIC. 12 – INTERNAL/EXTERNAL TROLLEY CISA 400-420 PAG.68

PIC. 13 – INTERNAL/EXTERNAL TROLLEY CISA 3000-3600 PAG.69

PIC. 14 – INTERNAL/EXTERNAL TROLLEY CISA 1000-1400 PAG.70

PIC. 15 – INTERNAL/EXTERNAL TROLLEY CISA 1350 PAG.71

PIC. 16 – PRINTER PAG.101

IMAGES
AUTOCLAVE SERIE CISA 3000 PAG.103

AUTOCLAVE SERIE CISA 3600 PAG.104

AUTOCLAVE SERIE CISA 400 PAG.105

AUTOCLAVE SERIE CISA 420 PAG.106

AUTOCLAVE SERIE CISA 640 PAG.107

AUTOCLAVES SERIES CISA 1000-1350-1400 PAG.108

AUTOCLAVES SERIES CISA 1000-1350-1400 (DETAILS) PAG.109

AUTOCLAVES SERIES CISA 1000-1350-1400 (DETAILS) PAG.110

ENCLOSEDS
ELECTRIC DIAGRAM 18 PAG.
HYDRAULIC PIPING SYSTEM 1 PAG.
PNEUMATIC SYSTEM 1 PAG.
DISPOSITION OF ELECTRIC BOARD COMPONENTS 1 PAG.
DISPOSITION OF IDRAULIC PLANT COMPONENTS 3 PAG.
DISPOSITION OF PNEUMATIC PLANT COMPONENTS 3 PAG.

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NOTICES FOR SAFETY


The notices following reported have the purpose to reduce the risk for the
working staff and to avoid to render unsafe the equipment in consequence of
a bad maintenance. Therefore whether the operators or maintenance staff
must to execute as indicated in this manual for the use and maintenance of
this sterilizer.

Caution must be done to the components, groups or points where


it is shown the indication of danger.

Caution must be done to open the electric board and connector


block signalled with the indication of “ danger – undervoltage”

WARNING the open cycle is programmed as textiles cycle, therefore


possible modifications involve a re-validation, from the part skilled staff,
before the use.

WARNING the procedure of calibration must be executed by skilled staff.


An improper use of this function can cause damages whether to the
sterilization process or to the staff.

The operators that use the sterilizer must be skilled for this
kind of activity.

The maintenance and repairing of the sterilizer must be


executed by technical skilled staff.

The loading area of the sterilizer must be kept cleaned in


order to avoid dangerous conditions due to the slippery
floor.

Baskets, containers, trays and packings in general and


internal trolleys must be handled wearing special gloves to
avoid burns at the end of the sterilization cycle.

Protective gloves must be worn whenever you are in


contact with the hot sterilization chamber.

Caution must be done for all non protected internal parts of


the sterilizer since it can cause burns during the
maintenance or repairing of the hot sterilizer.

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Protective gloves must be worn to verify the working of the


safety valve.

The electric power must be switch off before to start the


repairing or maintenance of the sterlizer.

For any reason must not be modified or tampered all safety


devices of the sterilizer.

The front panels of the sterilizer must be kept cleaned


using a soft cloth and non aggressive solutions for the
stainless steel.

The chamber must be kept cleaned using a soft cloth and


non aggressive solutions for the stainless steel.

Sharp tools must not be used to insert or remove the seal


gasket of the chamber from the seat.

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IMPORTANT NOTICES FOR LIQUID CYCLE

In case of autoclave with cycle for liquid activated, follows the instructions for
a correct execution of the same avoiding risks of explosion of bottles
containing hot liquids..

DO NOT STERILIZE LIQUIDS CONTAINED IN CONTAINERS


ERMETICALLY CLOSED IN THIS KIND OF STERILIZERS.

TO INSERT THE FLEXIBLE PROBE PRODUCT, PLACED IN


CHAMBER, IN THE CONTAINER OF LIQUID TO STERILIZE.

For to sterilize liquids contained in open containers use only the specific
cycle.

Use suitable containers for liquids and temperature.

Wait the end of the cycle before to open the door. The sterilizer
automatically will consent the opening only to the reaching of the
temperature of 80°C in the product.

To handle carefully the containers wearing protective gloves.

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IMPORTANT ADVICE ON THE RIGHT USE OF THIS


MANUAL

This manual has been developed to answer to all the user of the CISA
Sterilization Units.

In relation to the large range of device we product, and for the different use
of each one, to simplify we have created a unique manual book as reference
for all the user.

The following description, unless it is write in another way, are useful for
each CISA Sterilization Unit.

MEANING OF USE

The CISA Steam Autoclaves are used for the sterilization in Hospital
enviroment for all the temperature-proof material, included textile material,
surgical instruments, rubber material with his accessories, as following
described in the cycle specification.

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AUTOCLAVES CISA

TECHNICAL DESCRIPTION
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AUTOCLAVE SERIE 3000 AUTOCLAVE SERIE 3600

PIC. 1

AUTOCLAVE SERIE CISA 3000 AUTOCLAVE SERIE CISA 3600

FRONT VIEW

1 Sterilization Chamber
2 Technical space / Module
3 Load Side Control panel

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AUTOCLAVE SERIE 420 AUTOCLAVE SERIE 400

PIC. 2

AUTOCLAVE SERIE CISA 420 AUTOCLAVE SERIE CISA 400

FRONT VIEW

1 Sterilization Chamber
2 Technical space / Module
3 Load Side Control panel

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AUTOCLAVE SERIE 640

PIC. 3
AUTOCLAVE SERIE CISA 640:

FRONT VIEW

1 Steriliozation Chamber
2 Technical Space / Module
3 Load Side Control Panel

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AUTOCLAVE SERIE 1000

PIC. 4

AUTOCLAVE SERIE CISA 1000:

FRONT VIEW

1 Sterilization Chamber
2 Technical space / Module
3 Load Side Control Panel

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AUTOCLAVE SERIE 1400

PIC. 5
AUTOCLAVE SERIE CISA 1400:

FRONT VIEW

1 Sterilization Chamber
2 Technical Space / Module
3 Load Side Control Panel

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AUTOCLAVE SERIE 1350

PIC. 6

AUTOCLAVE SERIE CISA 1350:

FRONT VIEW

1 Sterilization Chamber
2 Technical Space / Module
3 Load Side Control Panel
4 Internal/External Trolley

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LOAD SIDE CONTROL PANEL LEGENDA

1 Touch screen (Display) PIC. 7


2 ON - OFF pushbutton
3 Stop cycle in course
4 Emergency Pushbutton (Key-resetting)
5 Panel printer
6/8 Key -Selector for chamber discharge and opening of doors
7 Open door pushbutton (manual)
9 Chamber manovacuumeter

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10 Steam generator manovacuumenter


16 Graphic recorder (in alternative/added to n.9-10)

UNLOADING SIDE CONTROL PANEL LEGENDA (DOUBLE DOOR EXECUTION)

PIC. 8

7 Closure door pushbutton


11 Opening door pushbutton
3 Stop cycle in course

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4 Emergency pushbutton (Key-resetting)


12 Led alarm
13 Led cycle in course
14 Led end cycle
15 Led door closed
9 Chamber manovacuumeter

1.0 GENERAL INFORMATIONS


1.1 Warranty

GUARANTEE:
12 months from the date of testing but not later than 15 months from the delivery. In
guarantee are included only the possible vices and defects of building and the first
matters: are excluded all the parts that may deteriorate to cause of carelessness or
improper use of equipment.

1.1.1 Other conditions


Other conditions to be agreed with CISA S.r.l

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1.2 Choice of cycles, load and packing


In the autoclave are foreseen a series of programmed and tested cycles suitable to the different kind
of materials to sterilize, as listed in the schedule. Furthermore, for to make better the quality of the
sterilization the autoclave consents to choose the typology of packing. In this way the cycle will fit to
the needs besides, the material to treat, also the type of packing, to avoid inconvenient which
condense residuals in the containers, humid or damaged medical paper and bags or tubes exploded.

Material Cycle °C min. Type of Packing


Textiles, porous material in general, empty 134°C 5 Containers, bags,
glassware and anyhow all things that are baskets, paper
temperature-proof
Gloves, catheters and rubber material in general 121°C 15 Containers, bags,
baskets, paper

Surgical instruments, empty glassware or other 134°C 5 Containers, bags,


baskets, paper

Surgical instruments, empty glassware or other 134°C 3 Baskets

Textiles, porous material in general, empty 134°C 18 Containers, bags,


glassware and anyhow all things that are baskets, paper
temperature-proof
Liquids 121°C 25 Open containers

Textiles, porous material in general, empty 125°C 13 Containers, bags,


glassware and anyhow all things that are baskets, paper
temperature-proof
Textiles, porous material in general, empty 115°C 65 Containers, bags,
glassware and anyhow all things that are baskets, paper
temperature-proof
Textiles, porous material in general, empty 105°C 70 Containers, bags,
glassware and anyhow all things that are baskets, paper
temperature-proof
Test Steam penetration test –Bowie & Dick – 134 °C 3 Special packing

Vacuum leak test – 10

Open cycle (20 cycles available)

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General Procedures:

The loading of the sterilizer must be executed in order that the steam can freely circulate and enter in
every package. The load of the autoclave must be distributed in uniform way, and it must not touch
the internal parts. All items to sterilize must be shown in such a way that each surface is directly
exposed to the sterilizing agent for the temperature and foreseen time. Place the bags and paper
packages in the suitable wire baskets in position such to be parallel to the flow of steam and do not
press them, the surfaces in polyethylene of the bags must be coupled with them, the small packages
must be placed on the top of packages with big dimensions. The instruments must be opened
disassembled and with the surface to sterilize free, the contained of the containers and baskets must
not be compromise. Particular instruments which containers, tubes, etc. must be placed with the
opening toward the bottom to avoid that condensate water collect, and air bubble forms. The tubes
must not be closed on sides and folded. The rubber gloves are impermeable to the steam must be
put laid and not folded. Once the autoclave is loaded and in temperature can be started to execute
the sterilization cycle choosing the same by touch screen. During the execution the parameters and
the stages can be checked always on the touch screen. At the end of the cycle, regularly executed,
we can open the autoclave on the opposite side for the unload of the material. Discharge the
materials avoiding to put them on cold surfaces and close again the door of the autoclave load side.
Check that the bags and packages are dried and integral verifying the right color change of the
external indicators of process. The steam sterilization can be executed on: surgical instruments,
metallic instruments, textile material for medication, non-sensitive rubber material, linen and textiles
material for sterile field let alone glassware.

1.3 Washing and packing of the material before the sterilization.


The material before to be submitted to a sterilization process, it must be correctly washed in all of its
parts, rinsed with water possibly dematerialized and dried so as to reduce the microbial charge
present and remove the presence of dirt, of oily substances and organic material, in that they could
interfere on the sterilization process.
The factors that determine a correct operation of detersion are: chemical (detergent), thermal
(temperature of water), time (time of immersion or bath) and mechanical (use of machines or
brushes).
The objects to submit to sterilization must have washed using detergent pH neutral.
For instruments of operating theatres must use a detergent product to use according to the
instructions pointed out by the manufacturer.
The detergents must be used according the instructions of use especially concerning the dilutions. A
product for which is foreseen a dilution at the moment of use must not be used to the pure condition,
it is necessary to prepare the preparation in a suitable container following the listed indications.
The cleaning operations must be performed separately from the packing operations to not cause
alterations to the packing materials, in practice the material to sterilize must be packed in a room
separate from the washing area.
The staff to such operation must be protected during all cleaning operations to avoid that there are
wounds, contacts with organic material or detergent products, beside it must pay particular attention
towards to sharpened and cutting edge instruments.

The precautions to keep are: remove coarse dirty from the object; immerse the open or
disassembled instrument in a container in which the product of treatment or detergent it has been
prepared for the fixed time by the manufacturers; friction the object with suitable sponges, brushes or
swabs in the internal and external parts do not use metal brushes or abrasive products; rinse with
running water possibly dematerialized, to dry, check the efficiency of instruments and in case to
lubricate with suitable products pH neutral; after the lubrication the surgical instruments must be
sprayed with the compressed air gun to remove the excess of lubricant.
In the use of cleaning products, or cleaning and disinfection combined the instructions of producer
must be followed with accuracy (time of action, concentration, temperature).
Only the exact dosing guarantees a perfect result of cleaning and disinfection, with the maximum
respect for the materials. A not sufficient dosing of alkaline product (false saving) it allows the risk of
corrosion in that it avoids for values of pH higher than 10,5.

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In the use of acid cleaning products, could produce corrosion for the presence of chlorine.
This it could avoid only with the use of dematerialized water. The instruments in colored anodized
aluminum lose their color with current methods of cleaning by machine and so lose also the coding
function. In the case of very dirty surgical instruments, incrusted (blood coagulated, rests of secretion
or other material) It could result necessary a further manual or ultrasonic cleaning. In such case it
must be examined carefully the instructions for the delicate mechanical treatment of the instruments
for microsurgery. In the cleaning by machine must eliminate, during the rinsing stage, all the rests of
the cleaning stage, otherwise it could present spots and coloring over the surgical instruments. The
use of a neutralization product could help this procedure and improve the result of rinsing. In the
practice it is verified that in the treatment of surgical instruments in cleaning and disinfection
machines, the best temperature for rinsing (besides for the following drying) is included between 70
and 95°C. At the appear of possible corrosion the rinsing temperature must be limited between 70
and 75°C. Using dematerialized water for rinsing, it could avoid spots and corrosion without limit the
temperature. The surgical instruments must be removed from the unit immediately after the end of
program must provide at a complete drying. If the instruments before the cleaning by machine are
immersed in a cleaning and disinfection solution, for to avoid the formation of foam in the unit it is
performed a rinse or it is used a product controlled foam. The instruments with long or narrow cavity
as for example metal catheters, metal aspirators, special cannel, etc. they must be rinsed also
inside.

The treatment with the machine of instruments for microsurgery and dental instruments as many
delicate, it must performed in the automated units only if it is assured a safe fixing of the instruments
during the working process. Handles and particular articulated could be treated in the machine if the
manufacturer foresee such method and if a safe fixing is assured. As soon as the program of the unit
is finished it must to execute a suitable treatment with suitable spray to eliminate possible humidity
passed inside of the instruments.
Rotating dental instruments (drills, milling machines and abrasive bodies) are suitable to the
treatment in machine only in limited measure. It is preferable the ultrasonic treatment. The same say
it for tools for roots. Hand-mirrors covered with rhodium steam, could be treated in machine. Rigid
endoscopes have to be disassembled according to the instructions of the manufacturer to may
execute the treatment in machine. The gaskets have to be removed. It must to treat in the machine
only that particulars of endoscopes expressly shown by manufacturer (excluded for example the
optics).
However for the treatment in machine the parts of endoscopes need of a suitable support inside the
machine.
It must to assure that also the instruments with internal cavity are cleaned well at their own inside.
The treatment in machine of the flexible endoscopes foresees their cleaning and disinfection in a
closed machine. It is not possible to use the usual disinfection and cleaning equipment. For
chemothermic processes the temperature must not exceed 60°C. For the endoscopes for which
occur a cleaning and disinfection of preparation outside of the unit, it must to use exclusively
disinfectants, detergents and detergent additives, that produce a little foam.

Before proceeding to other treatments it must to execute the leak tests described by the
manufacturer. In this way it recognizes at the right time drillings and fissures that, following liquids
penetrated inside a leak test before or during the execution of cleaning and disinfection program.
A flexible endoscope damaged must be sent immediately to the manufacturer enclosing a
description of the cause of the defect. For the treatment by machine it must to use only detergents
and disinfectants proper to the particular type of treatment to execute. The flexible endoscope must
be placed inside the unit in sure way. Suitable devices must assure a perfect rinsing of all channels
and of the external surfaces. In case of treatment by machine, the final rinsing should be executed
with sterile dematerialized water. Furthermore it is opportune can arrange of the drying device. For
the cleaning in the ultrasonic tank, the surgical instruments must be put in position of opening on
suitable sterilization baskets. Attention must be made so that neither the sterilization baskets, neither
tools of big surface (lead hands, other baskets) determine zones of shade for the ultrasounds. Warm
water without additive does not hand to satisfactory results of cleaning. Is necessary therefore to add
an appropriate product for the cleaning.

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It must respect the prescriptions of the manufacturer about the concentration and the temperature.
The temperature of the solutions of cleaning in the ultrasonic tank should be at least 40°C, otherwise
the cleaning effect is not assured.

A great temperature help the degasification of the cleaning solution and it makes easy the action of
the ultrasonic treatment. The appropriate use of a suitable product does not produce coagulation of
albominous substances also to high temperatures. Ao temperatures between 20 and 25°C it can be
used that cleaning and disinfection products that is foreseen for the use at these temperatures only.
An excessive concentration of dirt in the ultrasonic tank harms to the cleaning. Therefore the solution
must be renewed according to the intervals pointed out by the manufacturer. In the practice it is
verified that times of ultrasonic treatment from 3 to 5 minutes and frequencies than at least 35 kHz. it
can consider enough (to respect the prescriptions of the manufacturer). The tank of the ultrasonic
cleaner must be filled following the instructions of the manufacturer (quantity of water).
To assure a perfect cleaning of instruments they must be completely covered from the cleaning
solution. The instruments cleaned by ultrasounds must be submitted then to an accurate rinse by
hand or by machine. This rinse must be performed with clean water of quality at least equal to
drinkable water. It would be preferable in every case that was demineralized water to avoid the
formation of stains. At the end of the rinse the instruments must be immediately and meticulously
dried. The micro-instruments must be placed on special supports to avoid the damage of them.
To avoid a damage of the surfaces and the welding of the dental instruments, the ultrasonic bath
must not contain acid substances to remove the cement. The handles, the articulated parts and the
turbines can not be treated by ultrasounds.

The rotating dental instruments must be treated only with appropriate cleaning and disinfection
products. On the special supports is prepared for them foreseen. With this it avoids a damage for
mutual contact between the instruments (for example, because of alive edges, diamonds grain, etc.).
After a short rinse with water and the immediate drying, the rotating dental instruments must be
treated with a product against the corrosion resistant to the sterilization. The flexible endoscopes can
not be treated with ultrasounds. The accessories (valves, covers, pliers PE, catheters) can be
cleaned by ultrasounds.
The packing of the objects and materials to sterilize has the purpose to preserve the sterility of the
treated material up to the moment of the use, it must allow the penetration and the contact of the
sterilizing way with the surface of the object, it must to reduce the risk of contamination of the content
to the moment of the opening, it must be practical and comfortable.
The objects to sterilize can be manufactured singularly or assembled, in this last case it is correct to
follow the orientation of the packing for single necessity (set for medication, for intervention) rather
than the packing for quality that offers small hygienic guarantees.

The packing must be of small dimensions and once opened they must be used completely or
sterilized again.
Before proceeding to the packing: to check that the material is cleaned, That is entire and that is dry,
to get off the assembled parts removing corks and covers, to protect the points of needles and sharp,
to place plastics and rubbers in such way to preserve the original form, to roll up the pipes or the
very long materials they allow it without creating narrowing.
The packing in containers with filters is suitable for set of surgical instruments, laundry, gauzes and
tablets of medication.
Every time it is necessary to check the state of the filters, to replace them periodically following the
indications of the supplier, or when they result visibly altered however to follow to the indications of
guarantee of the manufacturer.
The contained material in the containers must not be compressed, the laundry should be positioned
vertically.
The packing in medical paper for the steam sterilization is suitable for the sets of laundry and
surgical instruments, not suitable for the packing of medication, materials of small entity or material
disomogeneis among them and deprived of support.

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The technique of packing must allow the opening of the package without involving the sterility of the
objects in it contained, therefore it is necessary to packing the packages in double orthogonal layer
using a methodic that allows to guarantee an effective protection an easy opening and an antiseptic
extraction of the content.
The double orthogonal layer is necessary in that the medical paper because of the presence of
micro-holes can not result an absolute barrier against the microorganisms. The double packing
introduce the advantage besides to be able to remove the external layer before the introduction of
the package in an area to low microbial charge preventing the entry of dust microscopic that
deposited it on the external packing. In the activity of packing do not use pins or clips for the closing.

The packing in bags or tubular of paper Kraft joined polypropylene/polyester is suitable for the steam
sterilization and for the single materials or of small and averages dimensions, for the sets of surgical
instruments, for laundry and medication.
The formalities of preparation foresee the choice of: a format of bags or tubular suitable considering
that the content must not occupy more than 3/4 with its volume. Besides it must be positioned the
content in order to guarantee correct maneuvers of opening and extraction to the moment of the use,
the hilt of the instruments must present easily accessible, the gauzes and the laundry must maintain
intact without opening the moment of the extraction. To check that the pointed or sharp material is
protected from supports in plastics and that all the bags are welded to the rims with thermo-welders
providing to leave a margin of opening of 5 cm. and what the welding is at least 1 cm. however not
less than 6 mm. and not higher than 12 mm. of continuous or multiple type.

For the material that must be used on sterile field it recommends the packing in double bag, both the
bags it intended like joined to polyethylene/polyester and Kraft paper must be welded singularly and
introduced in the sterilization unit.

Autoclaves CISA Pag.24


CISA S.r.l. - Manual of Use and Maintenance - Versione 4.0/00

1.4 Sterilization cycles


The following pictures show the diagrams pressure-temperature-time of the selected cycles:

STERILIZATION CYCLE AT 134°C – TEXTILES - t’= 5’

PHASE Abilit. Time in Temperature Pressure Vacuum Repetitions


ON/OFF Minutes °C kPa kPa N°
VACUUM TEST Off - - - - -
PRECONDICTIONING On - 134°C 180 30 5
HEATING On - 134°C - - -
STERILIZATION On 5 134°C - - -
COOLING Off - - - - -
DISCHARGE CHAMBER Off - - - - -
WASHING Off - - - - -
DRYING On 10 134°C - 25 -
AERATION On - - 105 95 -

Sterilization Cycle at 134°C for textiles, porous material in general, empty glassware and all the other
temperature-proof material, foresee the following phases:
-Injection of steam in jacket
-Fractioned vacuum until a chosen value (injection of steam alternated to vaccum section; this phase
have the function to copletely eliminate the air sack in chambwer and to warm the material)
-Injection of steam in chamber until the temperature of 134°C
-sterilization for 5 minutes
-Discharge steam chamber
-Final long vacuum in chamber until a chosen value and steam in jacket for the drying of the material
-Restoration of the baric condition in chamber with the injection of sterile air during the end of cycle

Autoclaves CISA Pag.25


CISA S.r.l. - Manual of Use and Maintenance - Versione 4.0/00

STERILIZATION CYCLE AT 121°C – RUBBER - t’= 15’

PHASE Abilit. Time in Temperature Pressure Vacuum Repetitions


ON/OFF Minutes °C kPa kPa N°
VACUUM TEST Off - - - - -
PRECONDICTIONING On - 121°C 150 30 5
HEATING On - 121°C - - -
STERILIZATION On 15 121°C - - -
COOLING Off - - - - -
DISCHARGE Off - - - - -
CHAMBER

WASHING Off - - - - -
DRYING On 10 121°C - 25 -
AERATION On - - 105 95 -

Sterilization Cycle at 121°C for surgical instruments in rubber material open and packed, foresee
the following phases:
-Injection of steam in jacket
-Fractioned vacuum until a chosen value (injection of steam alternated to vaccum section; this phase
have the function to copletely eliminate the air sack in chambwer and to warm the material)
-Injection of steam in chamber until the temperature of 121°C
-sterilization for 15 minutes
-Discharge steam chamber
-Final long vacuum in chamber until a chosen value and steam in jacket for the drying of the material
-Restoration of the baric condition in chamber with the injection of sterile air during the end of cycle

Autoclaves CISA Pag.26


CISA S.r.l. - Manual of Use and Maintenance - Versione 4.0/00

STERILIZATION CYCLE AT A 134°C – SURGICAL INSTRUMENTS - t’= 5’

PHASE Abilit. Time in Temperature Pressure Vacuum Repetitions


ON/OFF Minutes °C kPa kPa N°
VACUUM TEST Off - - - - -
PRECONDICTIONING On - 134°C 180 30 2
HEATING On - 134°C - - -
STERILIZATION On 10 134°C - - -
COOLING Off - - - - -
DISCHARGE Off - - - - -
CHAMBER

WASHING Off - - - - -
DRYING On 20 134°C - 25 -
AERATION On - - 105 95 -

Sterilization Cycle at 134°C for surgical instruments foresee the following phases:
-Steam in Jacket (incremental = 2, stand-by = 5, Conditioning= 0)
-Fractioned vacuum until a chosen value (injection of steam alternated to vaccum section; this phase
have the function to copletely eliminate the air sack in chambwer and to warm the material)
-Injection of steam in chamber until the temperature of 134°C
-sterilization for 5 minutes
-Discharge steam chamber
-Final long vacuum in chamber until a chosen value and steam in jacket for the drying of the material
-Restoration of the baric condition in chamber with the injection of sterile air during the end of cycle

Autoclaves CISA Pag.27


CISA S.r.l. - Manual of Use and Maintenance - Versione 4.0/00

STERILIZATION CYCLE AT 135°C – PRION - t’= 18’

PHASE Abilit. Time in Temperature Pressure Vacuum Repetitions


ON/OFF Minutes °C kPa kPa N°
VACUUM TEST Off - - - - -
PRECONDICTIONING On - 135°C 180 30 5
HEATING On - 135°C - - -
STERILIZATION On 18 135°C - - -
COOLING Off - - - - -
DISCHARGE Off - - - - -
CHAMBER

WASHING Off - - - - -
DRYING On 5 135°C - 25 10
AERATION On - - 105 95 -

Cyclo Prion at 135°C for suspect Prion virus infected material for 18 minutes,
foresee the following phases:
-Injection of steam in jacket
-Fractioned vacuum until a chosen value (injection of steam alternated to vaccum section; this phase
have the function to copletely eliminate the air sack in chambwer and to warm the material)
-Injection of steam in chamber until the temperature of 135°C
-sterilization for 18 minutes
-Discharge steam chamber
-Final long vacuum in chamber until a chosen value and steam in jacket for the drying of the material
-Restoration of the baric condition in chamber with the injection of sterile air during the end of cycle

Autoclaves CISA Pag.28


CISA S.r.l. - Manual of Use and Maintenance - Versione 4.0/00

DISINFECTION CYCLE AT 134°C – FLASH - t’= 4’

PHASE Abilit. Time in Temperature Pressure Vacuum Repetitions


ON/OFF Minutes °C kPa kPa N°
VACUUM TEST Off - - - - -
PRECONDICTIONING On - 134°C 120 10 1
HEATING On - 134°C - - -
STERILIZATION On 4 134°C - - -
COOLING Off - - - - -
DISCHARGE Off - - - - -
CHAMBER

WASHING Off - - - - -
DRYING On 5 134°C - 10 -
AERATION On - - 105 95 -

Flash cycle for disinfection at 134°C foresee the following stages:


-Injection of steam in jacket
-vacuum until a chosen value
-Injection of steam in chamber until the temperature of 121°C
-sterilization for 4 minutes
-Discharge steam chamber
-Final long vacuum in chamber until a chosen value and steam in jacket for the drying of the material
-Restoration of the baric condition in chamber with the injection of sterile air during the end of cycle

Autoclaves CISA Pag.29


CISA S.r.l. - Manual of Use and Maintenance - Versione 4.0/00

STERILIZATION CYCLE AT 121°C – LIQUIDS - t’= 25’

PHASE Abilit. Time in Temperature Pressure Vacuum Repetitions


ON/OFF Minutes °C kPa kPa N°
VACUUM TEST Off - - - - -
PRECONDICTIONING On - 121°C 120 10 1
HEATING On - 121°C - - -
STERILIZATION On 25 121°C - - -
COOLING On 20 80°C - - -
DISCHARGE Off - - - - -
CHAMBER

WASHING Off - - - - -
DRYING Off - - - - -
AERATION On - - 105 95 -

Cyclo at 121°C for liquid (OPTIONAL) foresee the following stages:


-injection of steam in jacket
-initial vacuum until a chosen value
-heating with steam in chamber until 121°C
-sterilization for 25 minutes at 121°C
-natural cooling until the temperature of 105°C
-Forced cooling by injection of water in jacket until a temperature in the liquid of 80°C
-Discherge water in jacket
- Restoration of the baric condition in chamber with the injection of sterile air during the end of cycle

Autoclaves CISA Pag.30


CISA S.r.l. - Manual of Use and Maintenance - Versione 4.0/00

STERILIZATION CYCLE AT 125°C - 125°C – t’= 13’

PHASE Abilit. Time in Temperature Pressure Vacuum Repetitions


ON/OFF Minutes °C kPa kPa N°
VACUUM TEST Off - - - - -
PRECONDICTIONING On - 125°C 120 10 5
HEATING On - 125°C - - -
STERILIZATION On 13 125°C - - -
COOLING Off - - - - -
DISCHARGE Off - - - - -
CHAMBER

WASHING On 5 125°C 60 10 1
DRYING On 5 125°C - 10 -
AERATION On - - 105 95 -

Sterilization cycle at 125°C (OPTIONAL) foresee the following stages:


-Injection of steam in jacket
-Fractioned vacuum until a chosen value (injection of steam alternated to vaccum section; this phase
have the function to copletely eliminate the air sack in chambwer and to warm the material)
-Injection of steam in chamber until the temperature of 125°C
-sterilization for 15 minutes
-Discharge steam chamber
-Final long vacuum in chamber until a chosen value and steam in jacket for the drying of the material
-Restoration of the baric condition in chamber with the injection of sterile air during the end of cycle

Autoclaves CISA Pag.31


CISA S.r.l. - Manual of Use and Maintenance - Versione 4.0/00

STERILIZATION CYCLE AT 115°C - 115°C – t’= 65’

PHASE Abilit. Time in Temperature Pressure Vacuum Repetitions


ON/OFF Minutes °C kPa kPa N°
VACUUM TEST Off - - - - -
PRECONDICTIONING On - 115°C 120 10 5
HEATING On - 115°C - - -
STERILIZATION On 65 115°C - - -
COOLING Off - - - - -
DISCHARGE Off - - - - -
CHAMBER

WASHING On 5 115°C 60 10 1
DRYING On 5 115°C - 10 -
AERATION On - - 105 95 -

Sterilization cycle at 115°C (OPTIONAL) foresee the following stages:


-Injection of steam in jacket
-Fractioned vacuum until a chosen value (injection of steam alternated to vaccum section; this phase
have the function to copletely eliminate the air sack in chambwer and to warm the material)
-Injection of steam in chamber until the temperature of 115°C
-sterilization for 65 minutes
-Discharge steam chamber
-Final long vacuum in chamber until a chosen value and steam in jacket for the drying of the material
-Restoration of the baric condition in chamber with the injection of sterile air during the end of cycle

Autoclaves CISA Pag.32


CISA S.r.l. - Manual of Use and Maintenance - Versione 4.0/00

DISINFECTION CYCLE AT 105°C - 105°C – t’=70’

PHASE Abilit. Time in Temperature Pressure Vacuum Repetitions


ON/OFF Minutes °C kPa kPa N°
VACUUM TEST Off - - - - -
PRECONDICTIONING On - 105°C 120 10 5
HEATING On - 105°C - - -
STERILIZATION On 70 105°C - - -
COOLING Off - - - - -
DISCHARGE Off - - - - -
CHAMBER

WASHING On 5 105°C 60 10 1
DRYING On 5 105°C - 10 -
AERATION On - - 105 95 -

Disinfection cycle at 105°C (OPTIONAL) foresee the following stages:


-Injection of steam in jacket
-Fractioned vacuum until a chosen value (injection of steam alternated to vaccum section; this phase
have the function to copletely eliminate the air sack in chambwer and to warm the material)
-Injection of steam in chamber until the temperature of 105°C
-sterilization for 70 minutes
-Discharge steam chamber
-Final long vacuum in chamber until a chosen value and steam in jacket for the drying of the material
-Restoration of the baric condition in chamber with the injection of sterile air during the end of cycle

Autoclaves CISA Pag.33


CISA S.r.l. - Manual of Use and Maintenance - Versione 4.0/00

Autoclave self-test programs


There are self-test cycles in way to permit the user a daily or periodical verify of
the functionality of the machine and the conformity to its construction standard:

Bowie and Dick TEST AT 134°C - B&D - t’= 210”

PHASE Abilit. Time in Temperature Pressure Vacuum Repetitions


ON/OFF Minutes °C kPa kPa N°
VACUUM TEST Off - - - - -
PRECONDICTIONING On - 134°C 180 30 5
HEATING On - 134°C - - -
STERILIZATION On 210sec 134°C - - -
COOLING Off - - - - -
DISCHARGE Off - - - - -
CHAMBER

WASHING Off - - - - -
DRYING On 10 134°C - 25 -
AERATION On - - 105 95 -

Autoclaves CISA Pag.34


CISA S.r.l. - Manual of Use and Maintenance - Versione 4.0/00

VACUUM LEAK TEST – VACUUM TEST – t’=10’

PHASE Abilit. Time in Temperature Pressure Vacuum Repetitions


ON/OFF Minutes °C kPa kPa N°
VACUUM TEST On 10 134°C 13 10 -
PRECONDICTIONING Off - - - - -
HEATING Off - - - - -
STERILIZATION Off - - - - -
COOLING Off - - - - -
DISCHARGE Off - - - - -
CHAMBER

WASHING Off - - - - -
DRYING Off - - - - -
AERATION Off - - - - -

VACUUM LEAK TEST in conformity to the norms; for this test is prepared a special fast-
connection for the precision manovacumeeter. (vacuum-switch Ø150 barometrically
compensed from 100 to 0mbar -div.1mbar as optional).
This cycle foresee the following stages:
-High-vacuum in chamber for a time of 10 minutes until the pressure of 70 mbar;
-Stop of the suction of the vacuum pump for 10 minutes;

The vacuum leak in 10 minutes cannot reach 13mbar.

Autoclaves CISA Pag.35


CISA S.r.l. - Manual of Use and Maintenance - Versione 4.0/00

With the open cycles is possible to create a sterilization cycle modificating the
parameters and the relative phases of the cycle. The phases are :

• VACUUM TEST
• CONDITIONING
• HEATING
• STERILIZATION
• COOLING (only for autoclaves with liquid cycle)
• DISCHARGE CHAMBER
• WASHING
• DRYING
• AERATION

For those phases we can modify :

VACUUM TEST

Enabling of the phase (ON/OFF)


The max leakage in millibar (mbar) in the difference of test time
The set of vacuum to reach to begin the stabilization (kPa)
Set of heating of the jacket (°C)
Max time of the vacuum test (min)
Max time to reach the vacuum set (min)

CONDITIONING

Enabling of the phase (ON/OFF)


First set of pressure (kPa)
Second set of pressure (kPa)
NB: the set of pressure are compared with the pressure in chamber to decide to
begin with the injection of steam or the vacuum stage.
Ex. If the chamber pressure is 100Kpa and the first set is 20Kpa, the machine will
start with the injection of pressure phase.

The jacket heating temperature (°C)


NB: the jacket temnperature is regulated to permit the reaching of the pressure
set. If the pressure correspondent to the selected temperature pressure is less
than the set of pressure, there will be an alarm of maximum phase.
Ex: Inserting a 200Kpa pressure set, we must insert the jacket temperature at
least at 123°C (see Table of referement steam temperature/pressure, fig.9)

The max time spent to reach the minimum set of Vacuum


The number of repetition vacuum/pressure

In this phase is possible to set the pre-conditioning parameter as :


Time of pre-heating of the material before the starting of the cycle (stand-by) (min)
Time of pre-heating before the sterilizaztion phase (min)
Enabling of the incremental pulsing (0=OFF, 1=ON)
Enabling of the maintenance of the pulsing pressure (0=OFF, 2=ON)
NB: The stand-by time in pressure is fixed by the STAND-BY parameter (min.)

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CISA S.r.l. - Manual of Use and Maintenance - Versione 4.0/00

This option allows to have a fixed incremental pressure set-point. Ex. Fixing the
pressure set-point at 200 kPa and the vacuum set-point at 20 kPa and 6 pulsing
number we will have:

200-20 =180 kPa , 180/6=30 kPa then,

1° pressure set-point = 20 + 30 = 50 kPa


2° pressure set-point = 50 + 30 = 80 kPa
3° pressure set-point = 80 + 30 = 110 kPa
4° pressure set-point = 110 + 30 = 140 kPa
5° pressure set-point = 140 + 30 = 170 kPa
6° pressure set-point = 170 + 30 = 200 kPa

HEATING

Enabling phase (ON/OFF)


NB: disabling this phase, the sterilization phase also will be disaled.
Heating set-piont (°C)
Ascendant ramp in °C/minute
Maximum time for reaching the set.
NB: fixing an ascendant ramp of 1°C/minute, to reach a set-point of 134°C sterting
from a temperature of 100°C we will take:
134-100= 34°C, or rather 34 minutes. Look to this time, first to fix any value.

STERILIZATION

Enabling phase (ON/OFF)


NB: Enabling this phase will be enabled also the heating phase.
Sterilization time (min), (only in case of B&D cycle this numer is write in seconds)
Enabling of the F0 parameter
This function permit the using of the real time (F0 disabled) or the virtual time
calculated on the increasing temperature (F0 enabled).
The user must have knowledge about the F0 theorema.
Selection of the type of sterilization. (only for double-functioning autoclaves)

COOLING (only for liquid tratment autoclaves)

Enabling phase (ON/OFF)


Cooling temperature (°C)
Cooling minimum time (min)

CHAMBER DISCHARGE

Enabling phase (ON/OFF)


Discendant ramp of the pressure in chamber expressed in mbar/minute until
atmosferic pressure (about) 105 kPa

WASHING

Enabling phase (ON/OFF)


Vacuum set-point (kPa)
Aeration set-point (kPa)
NB. The aeration set-point must be less than the vacuum set
Number of repetition of the vacuum/aeration stages
Time of stand-by under pressure of the first pulsing stage (min)
Jacket temperature set-point (°C)

Autoclaves CISA Pag.37


CISA S.r.l. - Manual of Use and Maintenance - Version 4.0/00

DRYING

Enabling phase (ON/OFF)


Vacuum set-point (kPa)
Time of stand-by under pressure (min)
Jacket temperature set-point (°C)

AERATION

Is not possible to fix any value for this phase.

Thery are fixed 20 open cycles in the autoclave memory, each one indentified by a
number. So the open cycle number 1 will be preinted on the printout as “OPEN CYCLE
01”. The user should take care of the tipology of the created cycle.

Autoclaves CISA Page 38


CISA S.r.l. - Manual of Use and Maintenance - Version 4.0/00

TABLE OF REFEREMENT SATURATED STEAM TEMPERATURE – STEAM PRESSURE

Temperature Pressure
°C kPa

100.0 93.9
101.0 98.2
102.0 102.7
103.0 107.2
104.0 111.8
105.0 116.4
106.0 121.2
107.0 126.0
108.0 131.0
109.0 136.0
110.0 141.1
111.0 146.4
112.0 151.7
113.0 157.1
114.0 162.7
115.0 168.3
116.0 174.1
117.0 180.0
118.0 186.0
119.0 192.1
120.0 198.4
121.0 204.8
122.0 211.3
123.0 218.0
124.0 224.9
125.0 231.8
126.0 239.0
127.0 246.3
128.0 253.8
129.0 261.4
130.0 269.2
131.0 277.2
132.0 285.4
133.0 293.9
134.0 302.5
135.0 311.3
136.0 320.4
137.0 329.7
138.0 339.2
139.0 349.0
140.0 359.1

PIC. 9

Autoclaves CISA Page 39


CISA S.r.l. - Manual of Use and Maintenance - Version 4.0/00

1.5 Safety systems


The autoclave is equipped of the following safety devices that makes it extremely reliable:
• Electronic device against the opening of the door in presence of pressure in chamber.
Verification by no.2 pressure gauges of the atmospheric pressure in chamber before the consent
of opening.
• Mechanical device against the opening of the door in presence of pressure in chamber with
micro of signalling.
Piston hydraulically connected to the chamber, that in presence of pressure stops the
mouvement of the door. The right working is verified through a magnetic limit switch.
• Overtemperature device of working during the sterilization phase.
Verification by no.2 temperature porbes, on the threshold of +3°C than the sterilization set.
• Device for defect of temperature during the sterilization cycles.
Verification by no.2 temperature probes, on the threshold of –0°C than the sterilization set.
• Light of presence steam in the sterilization chamber (ISPESL).
Selector placed in the control panel that open a drain valve.
• Device for the protection of max. pressure.
Spring safety valve certified ISPESL directly installed on the body of the steam generator.
• Device against the letting in of steam in chamber if the door is open or not perfectly closed.
Limit switch of righr positioning of the door(s) of load.
• Device that prevent the simoultaneously opening of the doors (two doors model).
Limit switch of right positioning of the door(s) of load.
• Safety device of minimum pressure for the opening of the door.
Pressure gauge hydraulically connected to the chamber, that consents the drain and the opening
of the door at atmospheric pressure in the manual manoeuvre.
• Safety device on the leak door
Verification of the pressure in the gaskets by pressure gauges.
• Safety device of max. temeprature resistances
Thermostat inserted in the body of the generator in contact with the resistances.
• Manual key selector for emergency of discharge and opening of the doors
It is placed on the control panel it consents to discharge the pressure in the chamber and open
the door in case of serious trouble to the automatic control system.
• Magnetothermics for the protection of motors
• Fuse and electric protection on the agent of the electric plant
Low voltage feederd with output SELV (Safety Extreme Low Voltage)
• Head emergency push button of stop of all the functions of the unit (restoration in stand-by with
use of key and start again of the functionality of the cycle with new command of start)
• Protection differential on the electric circuit steam production (resistances)
• Device that prevents the opening of the door in the cycle for liquids whether in the open
containers or closed, if the temperature inside of the liquid is not go down under 80°C (in the
autoclaves arranged to the sterilization of liquids in bottles).
Safeties accident protections
• Microswitches releasing mechanism on the electric board
• Double buttons (use of both hands) for manoeuvre of closure of the door
• Pressure regulator for the command and control device opening/closure door(s) that prevents to
exceed 150N of force applied.
• Emergency push-button placed on the control panel for the immediate stop of the working of the
sterilizer and short of voltage. Such push-button is tested for to resist to the adventitious
contacts.

• the pipings crossed by the stean and so reach high temperatures are insulated with
thermo-resisting materials. These pipings are stopped by the pneumatic valves that also reach
temperatures relatively higher but, seen their form and functionality they cannot be insulated. We
advice so a particular attention near of the same.

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CISA S.r.l. - Manual of Use and Maintenance - Version 4.0/00

1.6 Set-point safety systems and functionality


In the following diagram you have illustrated the components refferring to the security, the
functionality and their settings.

Component Set-point
Steam Generator Safety Valve SS3
3,5 Bar
Look at Idraulic scheme in annexes
Compressed Air Safety Valve SSP and pressure
regulator FRAC 1,9 Bar
Look at Pneumatic scheme in annexes
Gasket Pressostat SP10
0,5 Bar
Look at Idraulic scheme in annexes
Chamber Pressostat SP5
0,2 Bar
Look at Idraulic scheme in annexes
Resistance Termostat TC3
150°C
Look at Idraulic scheme in annexes

Funzionalità
Component Set-point
Discharge Termostat TC20
60°C
Look at Idraulic scheme in annexes
Steam Generator Pressostat SP4
3,0 Bar
Look at Idraulic scheme in annexes
Pressure regulator FRM
6,0 Bar
Look at Pneumatic scheme in annexes

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CISA S.r.l. - Manual of Use and Maintenance - Version 4.0/00

1.7 Operator codes

WARNING. Please note that in the Formaldehyde version of all series of autoclaves,
missing the management of the operator codes (ch. 1.7).
So, for this type of equipment exclude the chapter 1.7 of the present manual.

For the management of the equipment have been foreseen twenty different operators for each of
them it has been inserted a reference code. For each operator is available a level that identify the
function that change from 1 to 9 and each level has the possibility to execute fixed functions in the
unit (see schedule of picture 5). From level 1 to level 5 are operator functions, from 6 to 7
maintenance functions and 8 and 9 of supervision. These codes and relatives levels can be
changed according to the needs. The unit at its first activation will have the following configuration:

Operator n° Code Level Name


1 - 9 OPERATOR N.1
2 0002 1 OPERATOR N.2
3 0003 1 OPERATOR N.3
4 0004 1 OPERATOR N.4
5 0005 1 OPERATOR N.5
6 0006 1 OPERATOR N.6
7 0007 1 OPERATOR N.7
8 0008 1 OPERATOR N.8
9 0009 1 OPERATOR N.9
10 0010 1 OPERATOR N.10
11 0011 1 OPERATOR N.11
12 0012 1 OPERATOR N.12
13 0013 1 OPERATOR N.13
14 0014 1 OPERATOR N.14
15 0015 1 OPERATOR N.15
16 0016 1 OPERATOR N.16
17 0017 1 OPERATOR N.17
18 0018 1 OPERATOR N.18
19 0019 1 OPERATOR N.19
20 0020 1 OPERATOR N.20

At the starting of a cycle the name of the operator relative to the inserted code will be printed. The
operator code will be required every time that there is the necessity, for example for to reset an
alarm, for to do a manual advancing of phase or to use the function of calibration. Such functions
will be activated or not according to the level corresponding to the inserted code.

Autoclaves CISA Page 42


LEVEL START START START CHANGE CHANGE CHANGE HEAT MAINTE PARAM PARAM RESET MANUAL CALIBRA
OF THE B&D OPEN OPEN STANDARD DATE ING NANCE ETERS ETERS ALARM ADVANCING TION
CYCLE CYCLES CYCLES CYCLES AND 1 2
I TIME

Autoclaves CISA
*

* Function activated.
2

* *
3

* * *
4

* * * * * *

(1)Function activated with an additional code CISA.


5

* * * * * * *
6

* * * *
7

* * * * *
8

* * * * * * * * * * *
9

PIC. 10
* * * * *(1) * * * * * * * *

Page 43
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CISA S.r.l. - Manual of Use and Maintenance - Version 4.0/00

1.8 Alarms
The alarms that can intervene during the working of the cycle will be shown and printed. The display
will show the phase and the type of alarm passed and it will be possible to reset them only by code
(see 1.7). For some type of alarms is necessary an intervention from the part of technical staff before
to be resetted, the following list indicates the type of alarm:

TYPE OF ALARM LEVEL LEVEL LEVEL TECHNICAL


INTERVENTION
1 2 3

Cancelled cycle
Thermics
Shortage of water (1)
Minimum temperature (1)
Max. temperature (1)
Emergency temperature (1)
Max. phase time (1)
Damage transducer chamber
Damage Pt100 Chamber
Damage Pt100 jacket
Damage Pt100 product
(only for autoclave activated to
execute the cycle for liquids)
Door open (1)
Max. pressure (1)
Battery PLC
Max temperature of drain
Vacuum test not ok (1)
Max. % Steam (1)
Minimum pressure gasket (1)
Emergency push-button
Stop Manual
Manual selector
Shortage of power supply

(1) Only in the case of repeated alarms

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The alarms described in the list are the following:

- Cancelled cycle
This alarm intervenes when the cycle is cancelled using the procedure described in the touch-
screen.
- Thermics
This alarm intervenes when a thermic starts. This happens when there areproblems on the
motors of the vacuum pump or water pump or the power supply.
- Shortage of water
This alarm intervenes when a max. time for the load of water in the generator has been
reached.
- Minimum temperature
This alarm intervenes in the sterilization phase, when the temperature of the chamber goes
down under the selected threshold (sterilization temperature).
- Max. temperature
This alarm intervenes in the sterilization phase, when the temperature of the chamber rises
above the selected threshold (sterilization temperature + 3°C).
- Emergency temperature
This alarm intervenes when the temperature chamber exceed 140°C
- Max. phase time
This alarm intervenes when the time of phase exceed the selected set for that phase.
- Damage transducer chamber
This alarm intervenes when there is an anomaly in the signal of the pressure transducer.
- Damage Pt100 chamber
This alarm intervenes when there is an anomaly in the signal of the thermoresistance PT100 of
the chamber.
- Damage Pt100 jacket
This alarm intervenes when there is an anomaly in the signal of the thermoresistance PT100 of
the jacket.
- Damage Pt100 product
This alarm intervenes when there is an anomaly in the signal of the thermoresistance PT100 of
the product.
- Door open
This alarm intervenes when during a cycle the door limit switch does not signal the right closure.
- Max. pressure
This alarm intervenes when the threshold of max. pressure into the chamber is exceeded (3,5
bar , 450 kPa).
- Battery PLC
This alarm intervenes when the battery of the PLC must be replaced.
- Max. temperature of drain
This alarm intervenes when the drain temperature remains high ( > 60°C) for more than five
minutes.
- Vacuum test not ok
This alarm intervenes when the vacuum test does not form part of the fixed parameters (1,3
mbar/min).
- Max. degree of saturation/superheated (%) of steam in chamber
This alarm intervenes when the degree of saturation or superheating expressed in percentage
calculated between the pressure and temperature exceed the +/- 10 % .
- Minimum pressure gaskets
This alarm intervenes when there is a lowering of pressure in the line of the seal gaskets of the door.
- Emergency push-button
This alarm is shown after the restoration of the emergency push-button (n.7 pict. 2 and 3)
- Manual Stop
This alarn intervenes when the cycle is cancelled using the push-button stop on the control panel (n.5
pictures 2 and 3).
- Manual selector
This alarm intervenes when the key-selector placed on the control panel is activated (n.6 picture 2).

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- Shortage of power supply


This alarm intervenes when there is a shortage of power supply.

As we can see in the list for each kind of alarm exists a level:
- LEVEL 1
It is an alarm that is only visualized and it does not modify the sequence of the cycle
- LEVEL 2
It is an alarm that finish the cycle directly (AERATION PHASE and END OF THE CYCLE)
- LEVEL 3
It is an alarm that finish the cycle after to have executed a procedure of atmospheric restoration
In the chamber with three minutes of vacuum and one minute of aeration.

In the case of shortage of power supply in anny phase of the cycle, at the return of the voltage the unit is
put in stand-by. Only at the moment of the reset the described procedure for an alarm of level 3 will be
started. (par.2.18)

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2.0 MANAGEMENT OF THE AUTOCLAVE


2.1 PRELIMINARY OPERATIONS
To execute it in starting phase or pick-up again of the activity after the break of the unit:

The users that use the sterilizer must be skilled for this kind of activity.
The maintenance and repairing of the sterilizer must be executed by
skilled technical staff.

- Ensure that the cocks WATER ARRIVAL (R14 e R7 hydraulic diagram in the annexes)
and STEAM ARRIVAL (RV2 hydraulic diagram in the annexes, if the autoclave is
directly fed from the network) and AIR ARRIVAL (R16 hydraulic diagram in the
annexes) placed inside tge autoclave are open.

To execute at every start of the cycle:


- Check that the gasket is well inserted in the seat before to close the door.

Sharped tools must not be used for to insert o to remove the seal
gasket of the chamber from the seat.

- Check that there is paper in the printing unit.


(A red bar on the paper indicates the imminent end of the roll).

Do not pull the paper when the printing unit is running.

- Check the working of the ink tape.

2.2 STARTING OF THE AUTOCLAVE


- Check that the emergengy push-button (n.4 pictures 7 and 8) is not activated.
- Switch on the autoclave acting on the ON-OFF push-button (n.2 picture 7)
- Check that the key selector (n.6-8 picture 7) is in position with the key not inserted.

The display will show :

where :

reports the model of the autoclave


reports the total number of the executed cycles

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Open the door acting on the push-button (Menù Par. 2.3) and keep it pushed up to the whole
opening of the same.
- Put manually or by loading trolley the materials to sterilize.

- Close the door using at the same time the push-buttons (Menù Par. 2.3) and 7,
on the control panel (picture 7)

Push any point of the display to continue.

2.3 MAIN MENU

The display will show :

From the main menu is possible to enter at different functions of the unit:

relatives at the management of the cycles (par. 2.4 to par. 2.10)

relatives to the working conditions of the unit (par.2.11)

relatives to the programmed maintenance of the unit

relatives to the management of the technical parameters

2.4 PROCEDURES FOR THE STARTING OF A CYCLE

Push from the main menu

The display will show :

CHOICE OF THE CYCLE AGAINST THE MATERIAL TYPE


Select the cycle that you wish to execute in function of the type of material to sterilize. (see par.1.2)

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The cycles foreseen from the unit are the following:

- TEXTILES CYCLE at 134°C. E XPOSURE TIME 5’


This cycle permits to sterilize: textiles, empty glassware, porous materials etc.

- RUBBER CYCLE at 121°C. E XPOSURE TIME 15’


This cycle permits to sterilize gloves, catheters, rubber materials etc.

- SURGICAL INSTRUMENTS CYCLE at 134°C. E XPOSURE TIME 5’


This cycle permits to sterilize surgical instruments

- FLASH CYCLE at 134°C E XPOSURE TIME 4’


This cycle permits the disinfection of the surgical instruments contained in open trays

- PRION CYCLE at 135°C EXPOSURE TIME 18’


This cycle permits to submit to the sterilization treatment the material for a time of 18’

- LIQUIDS CYCLE at 121°C WITH NATURAL COOLING (OPTIONAL) EXPOSURE TIME 25’
This cycle permits the sterilization of liquids contained in open containers
DO NOT STERILIZE LIQUIDS CONTAINED IN CONTAINERS
ERMETICALLY CLOSED IN THIS KIND OF STERILIZERS.
INSERT THE FLEXIBLE SENSING PROBE, PLACED IN CHAMBER, IN THE
CONTAINER OF THE LIQUID TO STERILIZE.

- STERILIZATION CYCLE at 125°C EXPOSURE TIME 13’

- STERILIZATION CYCLE at 115°C EXPOSURE TIME 65’

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- DISINFECTION CYCLE at 105°C EXPOSURE TIME 70’

- STEAM PENETRATION CYCLE TEST (BOWIE&DICK)


EXPOSURE TIME 210 SECONDS

- VACUUM LEAK TEST LEAK TIME 10’ - MAX. LEAK 13 MBAR (1.3MBAR/MINUTE)

- OPEN CYCLE. Pushing this push-button we enter in the library of the open cycle

Push to exit and come back to the main menu

Push to start the cycle

If we select the open cycle,


the display will show :

Push to enter at the page of selection of the open cycle.

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It is possible to choose one of the 20 available cycles (programmed at the begin as textiles cycles).

Push to confirm and come back at the page of selection of cycle.

2.5 CHOICE OF THE TYPE OF PACKING


The display will show :

Push the type of packing with which the load has been prepared.
Push OK to confirm.

2.6 INSERTION OF LOT CODE


This function can be activated or disactivated according to the internal procedure of the management
system of the sterilized.
The display will show:

Digit lot code.

Digit to delete eventual mistakes.

Digit to create space between characters.

Digit to confirm

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And await few seconds while the display will show:

2.7 INSERTION OPERATOR CODE


The display will show:

Push the operator code.

Push to confirm

Push to delete the inserted numbers.

2.8 CONFIRMATION START OF THE CYCLE


Before to give the start at the cycle is necessary to confirm the inserted data.
The display will show: or, it will show:

Push to cancel the procedure and come back to the page relative at the selection of the
cycle.

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Push to confirm.

This message :

call the operator’s attention remember that one of the components of the unit has reached the number
of the fixed work hours. Anuhow such message does not undermine, the execution of the cycle. For to
visualize what is the interested component enter from the main menu in the section “maintenance” and
in case require the intervention of the skilled staff named for maintenance.

2.9 AUTOMATIC DRAIN OF STEAM GENERATOR


For autoclave that have the steam generator it has been foreseen the automatic drain every 15 cycles.
When we start the fifteenth cycle the display will show:

Push to have the drain of generator at the end of the cycle as foreseen.

Push to postpone the drain of the generator at the end of the next cycle if
there is the necessity to use again the unit immediately after the cycle.
The drainage procedure lasts about 5 minutes. After the restoration of water, the heating will start and
it will last about 20 minutes.
The drain generator procedure is executed to make better the performances of the autoclave
preventing the solidification of the calcium and, anyhow, it can be postponed for a unlimited number of
times.

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2.10 VERIFICATION CONDITIONS TO PROCEED AT THE START OF THE CYCLE:


Before to proceed at the start of the selected cycle the autoclave check the conditions of the
plants.
The display will show:

1) - Door(s) closed.
In case the door is not closed, proceed at the closure with the formalities quoted at paragraph
2.2 using in the same way the buttons on this screen.
2) – Jacket Steam.
At the starting the autoclave uses about 20 minutes for to reach the set, The manometer of the
jacket (n.17 picture 2) shall have to reach the pressure of 2,2 bar about.
3) - Water Pressure
It checks that there are not alarms due to the shortage of water.
4) – Printer Ready
It checks that there are not problems with the built-in printer. Notice that this is the last check the
machine do, so it will remain in red warning until other checks are successful: in case of alarms,
check first the other fault condition.
5) – No Alarm
It checks that there are not general alarms in the system or other alarms belonging the previous

cycle. In case of negative condition push the button to enter in the alarm resetting manu.
Once the conditions of the plant are verified the relative warning lights after it has the start of the
cycle.

Push from the reaching of all conditions for to cancel the procedure of the start of the
cycle and come back at the page relatives at the selection of the cycle (par. 2.4). Repeat so the
procedure with the formalities quoted in the previous pages.

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2.11 PHASE IN COURSE


This page is shown at the starting of the cycle and it shows the main parameters of the
autoclave.
It is also reachable at the END OF THE CYCLE from the main menu pushing

The display will show :

The following parameters are visualized in real time:


- Pressure and temperature chamber
- Temeprature jacket
- “F0” total of the cycle
- the percentage of the executed cycle.

If the autoclave is activated for to execute the cycle for liquids, the display will show:

The following parameters are visualized in real time:


- Pressure and temperature chamber
- Temeprature jacket
- “F0” total of the cycle
- the percentage of the executed cycle.

The push-button is relative to the function of manual advancing (par. 2.12) while the

push-button servs to cancel the cycle in course (par. 2.13).

Push to enter in a undermenu of selction (par. 2.14).

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2.12 MANUAL WORKING

This function must be used to the maintenance purpose only.

The manual working permits to advance the phases of the cycle manually forcing the automatic
procedure.

As from paragraph 2.11 pushing during a cycle is possible to enter to the manual advancing
function. An operator code will be requested (par. 2.7) for the control of the level relatives at this
function (as from schedule at paragraph 1.7).
After the verification the level of the display will show:

With the manual working is possible to force the automatic sequence for to execute the functions of
maintenance.
Await that push-buttons is lighted before to push it.

Push to advance of phase. Until the push-button has not been pushed the cycle continue
automatically. Once pushed the automatic cycle will not executed and it needs finish it manually.

Push to exit.
The display will show the phase in course (par. 2.11) if a cycle is in execution, otherwise the main
menu will be visualized (par. 2.3).

2.13 CANCELLATION OF THE CYCLE

As from the paragraph 2.11 pushing is possible to cancel the cycle in course.
The display will show:

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Push to continue the run of the cycle in course.

The display will show again the phase in course.

Push because the autoclave starts the cancellation procedure of the cycle in course.

2.14 UNDERMENU OF SELECTION

As from paragraph 2.11 push to enter to a undermenu:


The display will show:

2.15 SET-POINT

Digit to compare the set value of the phase in course with the value of the
programmed value.
The display will show for 30”:

It are visualized:
-temperature chamber in °C;
-pressure chamber in kPa;
-time phase in second
-number of pulsations of vacuum/pressure.

The warning light switch on shows the parameter in comparison, according to the phases.
During the B&D cycle, in the sterilizatino phase, the phase time will be expressed in seconds.

Push to come back to the visualization of the page menu. (par. 2.14)

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2.16 PAGE VALUES

Push to visualize the process values in the chamber and in the jacket.

The display will show for 30”:

They are visualized:


-temperature jacket in °C,
-temperatures chamber in °C;
-pressures chamber in kPa;
-percentage of insaturation of steam.

Push to come back to the visualization of the page menu (par. 2.14).

Push to enter in the function of calibration. (par. 3.11)

2.17 PAGE DIAGRAM


Push to visualize the graph with the state of the temperature chamber in
function of the time relatives at last 30 minutes of the cycle in course. The graph is adjourned every
10 seconds transferring the last value on the right.
The display will show for 30”:

Push to come back to the visualization of the page menu (par. 2.14).

Digitare per tornare alla visualizzazione del menu’ pagina (par. 2.14).

Digitare per ristampare l’ultimo diagramma in memoria.

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2.18 PAGE ALARMS


Push from the menu of the paragraph 2.14 to visualize the alarms in course
already previously resetted.

This page is automatically visualized ebery time that an alarm intervenes call the operator’s attention
with an acoustic sound prolonged.

The display will show:

Push for to visualize all the alarms in course (in presence of more than one alarm).

Push to silence the acoustic alarm.

Pushing at the first notice of alarm the operator code will be requested (par. 2.7) for to
silence. (see list paragraph 1.7)

Once the operator code is inserted with the suitable level it comes back to the menu of selection of
paragraph 2.14 if the cycle is in execution. If the alarm is appeared at the end of the cycle, after the
reset, the menu paragraph 2.3 will be visualized.

After to have resetted the alarm during the cyclem at the endthis page will be visualized again for to

remember at the operators that an alarm is intervened, push to come back to the main menu.

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2.19 END OF THE CYCLE


The end of the cycle is shown by a flashing acoustic signal (max. time 5 minutes) and printed.

For to silence the signal push

The display will show:

if the cycle just finished is a sterilization cycle, and it will be possible open the door unload side (in the
autoclaves with double door version).

Pushing the screen return to the main menu and will be possibile to open the
loading door.
Once open the loading door, will be impossibile to open the sterile side door (double door
execution) until the end next validcycle.

Pushing the menu return to the previous screen.


The doors in the double door autoclaves are interblocked, this means that it is not possible
open a door if the other one is opened. The door unloading side can be opened only after a
sterilization cycle rightly executed and it can continue open and close until the loading side
door opens.

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At this point it is possible open the door keeping pushed the push-button ( menu
par. 2.3) and n.11 pictures 8 until the whole opening and so take out the material.
The display will show:

if the cycle is just finished is a test (B&D or vacuum test), and it will be not possible
open the door of unload side (in the autoclaves with double door version).

Push on the display for to come back to the main menu. (par. 2.3)

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2.20 PRINTS
For each cycle that we start a print in real time is created.
Hereinafter an example of print of an executed cycle:

Heading (par.3.9)

Autoclave model
Date and time of start of the cycle

Serial Number
Operator name
Lot code (if activated, par.3.9)

Selected cycle with the indication of the


temperature and sterilization time.

Type of heating , of load, activation F0.

Indication of the time, temperature,


pressure of the phase in course.

Indication of the hour, temperature


chamber and pressure chamber at the
moment of the change of the sub-phase
and indication of the sub-phase with the
relative set-poins.

Real time value


Sub-phase with indicationof the set.

Continue……………….

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Phase with indication of the set.


Print of the values of temperature and pressure
each 30 seconds (par.3.8)

Real time value


Phase with indication of the set.

Total time of the cycle, progressive number


Max. and minimum temperature reached in
sterilization and ireal time values of time,
temperature, pressure of end of the cycle
Indication of the cycle regularly executed

Ordinate with the temperatures in °C

Diagram of the cycle. The dashed trace represent


the pressure, the continue trace represent the
temperature. (if activated, par. 3.8)

The point that across vertically the diagram


represent respectively the atmospheric pressure,
the 121°C and the 134°C.

Ordinate with the pressures in bar relatives

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Hereinafter an example of print of a cycle executed and non regularly ended:

Heading

Autoclave model
Date and time of start of the cycle

Serial Number

Operator code
Lot code (if activated, par.3.9)

Selected cycle with the indication of the


temperature and the sterilization time.

Type of heating , of load, activation F0.

Indication of the time, temperature, pressure of


the phase in course.
Indication of the hour, temperature chamber and
pressure chamber at the moment of the change
of the sub-phase and indication of the sub-phase
with the relative set-point

Real time value


Sub-phase with indication of the set.

Immediate value
Indication of intervention of an alarm

Type of alarm

Total time of the cycle, progressive number and


real-time values of time, temperature, pressure.
Indication of the cycle non regularly executed

Ordinate with the temperatures in °C


Diagram of the cycle. The dashed trace represent
the pressure, the continue trace represent the
temperature. (if activated, par. 3.8)
Ordinate with the pressures in bar relatives.

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2.21 LOADING/UNLOADING OPERATIONS


The loading/unloading of the baskets, trays, containers in and out the sterilizer are simplified by an
internal trolley system that permit the charging and the transportation from the packing site to the
sterilizer and the discharge at the end of cycle.
There are some different models of internal and external trolley, with different dimensions in
relation to the dimension of the sterilization chamber

TROLLEY mod. CISA 640-400/420-3000-3600


For the right use of the trolley system follow the instruction before (fig 11-12-13):

1- remove the metallic shelf of the internal trolley (1) and charge the material inside the bottom
part of the trolley (2).
2- replace the grid shelf in its position (1) adjusting the high changing the position of the metallic
support (3)
3- Charge the material on the upper side.
4- Move the system (2-4) by the handle bar (9) with the blocking device (6) in block position;
5- Take the system in front of the sterilizer and open the chamber loading door. Insert the edge of
the external trolley until reach the edge of the chamber using the rail (7)
6- rotate the handle (5) to block the external trolley to the sterilizer (4) and at the same time
unlock the movement of the internal trolley (2),
7- push the trolley (2) in the sterilization chamber using the rails of the external trolley (7).
8- rotate the handle another time (5) lo unlock the external trolley (4) from the autoclave.
9- concerning the unloading operation of the material, proceed in the inverse way placing the
extrnal trolley (4) in front of the sterilizer and opening the door.
10- Lock the external trolley to the autoclave as in point 5
11- pull the internal trolley (2) wearing heat-protection gloves, until it is completely on the external
trolley (4)
12- lock the trolley (4) rotating the handle (5) and unlocking the external trolley (6)

- ATTENTION! This movement system must be used with care, paying


attention that the handle in fig 6 be in vertical position, hence
functioning as a block for the internal trolley (2), when it is charged on
the external trolley.

ATTENTION! The handle (6) have double function to block the external
trolley (4) to the sterilizer (unlocking of the internal trolley (2) and to
blocking the internal trolley (2) during the movemet on the external
trolley (4).

ATTENTION! BURNING PARTS!


After the sterilization cycle pay attention in using heat-protection
gloves to move both internal and external trolley or to manipulate the
material inside..

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TROLLEY mod. CISA 1000-1400-1350


For the right use of the trolley system follow the instruction before (fig 14-15):

1- remove the grid shelf (1) and charge the material inside the trolley (2) in the
bottom shelf
2- replace the grid (1) at the right position, adjusting the height changing the
position of the metallic support for the grid (3)
3- Charging the upper part of the shelf
4- moving the system (2);
5- take the system in front of the sterilization chamber and open the door. Insert
the whole trolley inside the chamber of the sterilizer (4), until the complete
loading.
6- are not necessary blocking or self-blocking system.
7- To unload the material proceed in the inverse way.
8- pull the trolley (2) wearing heat-protection gloves until it is entirely get out from
the sterilization chamber.
9- Unload the trolley (2) in the same way.

ATTENTION! BURNING PARTS!


After the sterilization cycle pay attention in using heat-protection
gloves to move both internal and external trolley or to manipulate the
material inside..

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INTERNAL/EXTERNAL TROLLEY AUTOCLAVE SERIE 640

PIC. 11

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INTERNAL/EXTERNAL TROLLEY AUTOCLAVE SERIE 400-420

PIC. 12

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INTERNAL/EXTERNAL TROLLEY AUTOCLAVE SERIE 3000-3600

PIC. 13

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INTERNAL/EXTERNAL TROLLEY AUTOCLAVE SERIE 1000-1400

PIC. 14

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INTERNAL/EXTERNAL TROLLEY AUTOCLAVE SERIE 1350

PIC. 15

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2.22 LABEL REPRINTING


This software permit you to reprint any number of label of the last cycle ended valid.
The display will show:

Insert the number of the label to print and push

To begin the printing push

To exit push

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3.0 TECHNICAL FUNCTIONS


3.1 – PROCEDURE FOR THE MANAGEMENT OF THE TECHNICAL PARAMETERS
Push from the main menu (par. 2.3)

The display will show:

Insert its own operator code.


According the correspondent level to the interrupted code a menu of selection to the functions
relatives at that level will be visualized (see list par.1.7)

3.2 – ACCESS TO MENU


The operators with level from 1 to 3 do not have a technial menu while from level 4 to level 9 the
following menu will be visualized

LEVEL 4 and 5 : common to LEVEL 8 and 9

LEVEL 6 and 7 LEVEL 8:

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LEVEL 9:

where :

Permits to change the date and current time (par.3.3)

Permits to change the type of heating (par.3.4)

Permits to change the parameters of the open cycles (par.3.5)

Permits to change the parameters relative to the maintenance (par.3.7)

Permits to change the parameters relative to the print (par.3.8)

Permits to change the parameters relative to the management of the autoclave (par.3.9)

Permits to change the parameters of the standard cycles (par.3.10)

Permits to enable/disable the selectable cycles (par.3.10)

Pushing from the menu of level 8 or 9 will be visualized the menu in common to the level 8
and 9.

3.3 CHANGE DATE AND HOUR

Push from menu of selection (par.3.2).

The display will show:

Shift with arrows on the parameter to modify and select by keyboard the wished values.

Push to exit , Push to confirm

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Push to memorize

3.4 MODIFICATION OF THE HEATING SYSTEM

Push from menu of selection (par.3.2).


The display will show:

Choose the type of heating and push to memorize.

3.5 MODIFICATION OF THE PARAMETERS IN THE OPEN CYCLES

CAUTION the open cycle is programmed as textile cycle, therefoer possible


modifications involve a validation from the part of skilled staff, before the use.

Push from the menu of selection (par.3.2).

The display will show:

Push to continue
The display will show:

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Insert the number relative to the cycle that it wants to modify.

Push to confirm

At this point the display will show different phase according to the parameters to modify. Proceed
as specified for the modification of parameters (par.3.6).

3.6 MODIFICATION OF THE PARAMETERS OF CYCLE


All parameters are modifiable by keyboard below reported.

where:

select the phase select the parameter to change

insertion values

confirm

comes back to zero the selected values Inserts the decimal values

it executes or not the phase according which of the two is flashing.

As soon as an open cycle or standard cycle to modifyis selected the parameters relative to the phases
that make the cycle will be visualized. The phases are:

• VACUUM TEST
• CONDITIONING
• HEATING
• STERILIZATION
• COOLING (only for autoclaves with liquid cycle)
• DRAIN CHAMBER
• WASHING
• DRYING

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See paragraph 1.4 – open cycle for other informations.

The first phase that will be visualized for the modification will be the phase VACUUM TEST.
The display will show:

The following parameters are changeable:


Leak: value in mbar of the max. leak
Vacuum: set point minimum that must to reach the pressure in chamber
Heating temeprature of regulation jacket
Time: duration of the test
Max time : max time used for to reach the set.

Furthermore, it has two fixed parameters, or:


Stabilization of the duration of 5 minutes and Balancing of the duration of 1 minute.

Pushing we go to the following phase.

PHASE 2 - CONDITIONING (Vacuum-steam)


The display will show

Set 1 and Set2 Minimum/maximum value of the pressure degree


Max. time: Max. time used for to reach the set of rpessure and vacuum
Heating Adjustment temperature steam jacket
Rep. no.: For many times repaet the same phase

OPTION VALID FOR CONTAINERS ONLY:


This option consents to select the necessary time for phr-heat of material, during the conditioning
phase and only when the same have been packed in container.

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The display will show:

Stand-by: initial await time before the start


Pre-heating: pre-heating time before the sterilization
Rise-up it activates the rise-up system

Push to confirm Push to memorize

PHASE 3 - HEATING
The display will show

Heating Adjustment temperature chamber and jacket


°C/min: Increase of temperature chamber
Max time : max time used for to reach the set.

PHASE 4 - STERILIZATION
The display will show

Temper. Adjustment temperature of sterilization in minutes


Time: Adjustment temperature of sterilization in minutes

Pushing the display will show:

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Push to choose the type of sterilizing agent/mean

Push to activate or not the “F0” function

Push to confirm

PHASE 5 – DISHARGE CHAMBER


The display will show

kPa/min.: it shows the decrease of the pressure in chamber until to the atmospheric pressure

PHASE 6 - WASHING (vacuum - air)


The display will show:

Set 1 and Set 2 : Minimum/maximum value of vacuum degree


Time : Stay time to the first vacuum
Heating : Adjustment temperature jacket
N.rep.: number of pulsations vacuum-air

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PHASE 12 - DRYING
The display will show:

vacuum: set point vacuum that must to reach pressure in chamber


Heating Adjustment temperature jacket
Time: duration of the vacuum set
Max. time: max. time used for the reaching of vacuum set

CALCULATION OF THE “F0” (EXECUTED ONLY WITH PHASE 4–STERILIZATION - ACTIVATED)


After to have selected every phase , the theoretical F0 is calculated for the selected
sterilization parameters;

if F0 ≥ 10, the display will show: if F0 ≤ 10 the display will show:

Push to continue
Push to continue

Push to come back at the phase in


which a parameter has been selected.

At this point the autoclave asks confirmation of th eright selection of the parameters.
The display will show:

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Push to come back at the first phase, verify, select again and continue

Push to come back to main menu

Push memorize all inserted parameters in the no. of the open cycle opened

The display will show:

await some seconds , before to come back to the menu of choice (par. 3.2)

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3.7 MODIFICATION OF PARAMETERS RELATIVE TO THE MAINTENANCE


Push from menu of selection (par.3.2)
The display will show:

This function permits to enter and modify parameters relative to the maintenance of the components to
take care.

Push for to List of It reports in


shift and components hours the lapse
It reports in hours
modify the to take care of time to
the data of
parameters proceed to the
reference for the
maintenance.
maintenance (data
Select the
modifiables)
values equal to
the SET
Where :

AIR F. Bacteriological air filter


DIS. F. Discharge filters
SAF. V. Safety valves
N. R. V. Non return valves
PNE. V. Pneumatic valves
VAC. P. Vacuum pump
SAF. B. Safety block
GASK. Door seal gasket
GENER. Generator
COMPR. Compressor

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3.8 MENU’ PARAMETER 1

Push from menu of selction (par.3.2).

The display will show:

Pushing the option of automatic print of the diagram time, temeprature


pressure at the end of the cycle is activated (falshing push-button). For desactivate this
function push a second time the push-button.

Shift with arrows on the parameters that it wants to select.

It indicates the interval of time expressed in seconds to have the


print of temperatures and pressure, in the sterilization phase and
during the vacuum test. For the vacuum test the print is always
cadenced according the selected interval.
In the sterilization phase, selecting the tolerance of temperature in
the range whenever we exit from the fixed limit it occours
automatically the print of the temperature and pressure. For the
cycles the print is always cadenced according to the range, if
selected.
With range equal to “0” all cycles keep in consideration of the interval of time.

3.9 MENU’ PARAMETER 2

Push from the menu of selction (par.3.2).


The display will show:

ALL THE OPTIONS ARE ACTIVATED AT FLASHING PUSH-BUTTON.

activates the request of the lot of productionbefore the starting of the cycle.

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it consents the modification of the heading in the printer.

it consents the modification of the codes and operator levels.

For to change the data relative to an operator go with push-buttons in the range So push
.

the operator’s number that it wants to visualize/modify and push the push-button to confirm.

At this point is enough to go to the range for to change the operator’s code, and on for to

modify the level. Pushing the push-button it can modify the name. When at the
start of the cycle the operator will insert the code and his name will be automatically printed on the
print.
NOTE: It is not possible to modify the level of the operator no.01 (level 9), in that in the management
of the autoclave is necessary at least an operator of level 9.
So:
Insert the no. of the Insert the
Insert the operator
operator from 01 to code 4 numbers operator level
20 from 1 to 9

Modify the parameters use the arrows

Modify the wished parameter through keyboard and push after each modification to
confirm.

Push to associate the name of the operator and to the above.mentioned


parameters.
The display will show:

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Push to make personal the heading of the print.


The display will show:

For both of visualizations:

Push to confirm Push to cancel

Push for space

Push to print the list with lot, code, level and name of the 20 operators.

NOTE: At the beginning of the cycle will be printed the description of the lot only if the

function is activated.

Pushing in this menu, permit to enable/disable the type of material choice request,
after the begin of a cycle.
When is enabled this button remain evidenced.

Pushing in this menu permit ot the user to enable/disable the operator ccode
request after the beging of a cycle.
When is enabled this button remain evidenced.

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3.10 MODIFICATION OF THE STANDARD CYCLES

CAUTION the standard cycles selected on the unit have been validated, therefore
any modification of the same involve its validation from the part of the skilled
staff, before the use.

Push from the menu of selection (par.3.2).

The display will show:

Push to continue

The display will show:

Insert the code for the modification of the open cycles supplied by CISA. For to obtain this
code send by FAX the requiest specifying the Serial Number that appears on the print (ES:
SN0000-00-00-00-0000000)
The display will show:

Choice the standard cycle that it wants to modify and proceed as specified for the
modification of the parameters. (Par.3.6).

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3.10.1 STANDARD CYCLE CONFIGURATION

Pushing in the selection menu (par.3.2).

the display will show:

Choose in this screen the cycle to eneble/disable

3.11 CALIBRATION

The calibration procedure must be executed by skilled staff. An improper


use of this function can cause damages whether to the sterilization process
or the staff.
NOTE: For this function is necessary the certified instruments of reference (EX. drain
temperature, manometer sample etc.)
The function of calibration acts on the analogue values of temperature and pressure that are
pointed out by the unit. These analogue values are converted with a linear function as from the
following diagram:

where points A2 and B2 are the extremes of the values to convert in input and A1 and B1 are the
correspondent extremes in output. Took a value in input P2 its correspondent value in output P1
will be the projection of the point P2 on the axis generated from A1-A2 , B1-B2 in the points A
and B. So a modification on the abscissa of the points A1 and B1 will modify the axis A1-A2 , B1-
B2 and the consequent projection of P2 on the point P.

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This is the resultant axis modifying the point A1. For to obtain the same point P1 on the abscissa
, the value of P2 should get near to the point A2 on the ordinate.

This is the resultant axis modifying the point B1 . For to obtain the same point P1 on the abscissa
, the value of P2 should get near to the point B2 on the ordinate.
The scale of temperature is 0 – 200,0 °C, expressed in tenth of degree 0 –2000.
Considering a possible negative error in the conversion of the signal in input, the values of A1 e
B1 are added at a whole value of 1000. After the interpolation for the calculation of P1 so a such
value will be subtracted the initial value of 1000. The values relative to the temperature of A1 and
B1 so will be:
A1 = 1000
B1 = 3000
The scale of pressure is 0 – 600 kPa , expressed in millibar 0 – 6000.

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As for the temperature the values of A1 and B1 are added at a whole of the value of 1000. The
values relative to the pressure of A1 and B1 so will be:
A1 = 1000
B1 = 7000

Hereinafter is reported the procedure for the modification of values A1 and B1.

Push to enter in the function of calibration. (par. 2.16)


The operator code will be requested (par. 2.7).
After the verification of the level (list par. 1.7)
The display will show:

Push to continue,

The display will show:

Select the component to calibrate.

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CALIBRATION OF THE CHAMBER TEMPERATURE.

The temperature probes chamber are two, both placed in the drain, so it needs draw them out from
their position and put them in a system at reference temperature.
Await the stabilization and proceed to the calibration:

A1

P1

B1

PROBE

The display will show the values of ZERO (A1) and SPAN (B1) of the first probe in the half on the
left and of the second one on the right. Acting on the selectors is possible to change the values of
ZERO and SPAN verifying the result obtained P1.

NOTE: The modifications applied to the values A1 and B1 of the probe 1 are immediate.

pushing the push-button the screen will return to the main menu.

For to determine the values of A1 and B1 it needs to check more points of reference as for
example:

- 0°C
- 121°C
- 134°C
- 150°C

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CALIBRATION OF THE CHAMBER PRESSURE

As the temperature also the pressure is took by two sensors. So it will be necessary connect to the
chamber a pressure transducer, or to apply directly a pressure of reference to the sensors.

A1

P1

B1

SENSOR

The display will show the values of ZERO (A1) and SPAN (B1) of the first sensor in the half on the
left and of the second one on the right. Acting on the selectors is possible to change the values of
ZERO and SPAN verifying the result obtained P1

NOTE: The modifications applied to the values A1 and B1 of the sensor are immediates.

pushing the push-button the screen will return to the main menu.

For to determine the values of A1 and B1 it needs to check more points of reference as for example:

- 0 kPa ( -1,0 bar )


- 100 kPa ( 0,0 bar ) atmospheric pressure
- 200 kPa ( 1,0 bar )
- 300 kPa ( 2,0 bar )
- 450 kPa ( 3,5 bar )

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CALIBRATION OF THE JACKET PRESSURE


As the temperature also the pressure is took by two sensors. So it will be necessary connect to the
chamber a pressure transducer, or to apply directly a pressure of reference to the sensors.

A1

P1

B1

SENSOR

The display will show the values of ZERO (A1) and SPAN (B1) of the first sensor.
Acting on the selectors is possible to change the values verifying the result obtained P1.

NOTE: The modifications applied to the values A1 and B1 of the sensor 1are immediates.

Pushing the push-button the screen will return to the main menu.

For to determine the values of A1 and B1 it needs to check more points of reference as for example:

- 0 kPa ( -1,0 bar )


- 100 kPa ( 0,0 bar ) atmospheric pressure
- 200 kPa ( 1,0 bar )
- 300 kPa ( 2,0 bar )
- 450 kPa ( 3,5 bar )

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4.0 MAINTENANCE
4.1 GENERAL INFORMATIONS ABOUT MAINTENANCE
All informations quoted in this chapter are destined to skilled staff that have received suitable
electric and hydraulic notions for to intervene in case of failures of different nature.

CAUTION to the chain and the pignon for the lifting of the doors.

CAUTION The autoclave has not a general switch. Before to execute


electric maintenances switch off the voltage upstream of the same
autoclave.
CAUTION Some internal parts of the autoclave (tubes, valves,
surfaces) are at high temperatures.

4.2 PROGRAMMED MAINTENANCE


From the main menu (par. 2.3) is possible to enter to the data of the preventive maintenance. This
function consents to verify the right working of the components signalling in advance the limit of
functionality of the same.

Push from the main menu


The display will show the incomplete time (expressed in hours) to proceed to the replacement or
review of the different components.

Push to slide all interested components.

Push to come back to the main menu.

MAINTENANCE PAGES

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For to enter in any component of the unit the person who make the maintenance, must be provided of
the key for opening of the modulo and of the tools for to remove the lateral panels of the unit, after to
have adopted all safety measures of the case to avoid to be in direct contact with elements under
voltage, in mouvement or high temprature. (see par. 3.7).

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4.3 FURTHER USEFUL MAINTENANCE ADVICES

Further as indicated from the Touch Screen is anyhow, advisable to execute periodically the following
preventive maintenance operations:

TO VERIFY the perfect working of the control and command device like (manometers,
manovacuumeters, recorders, printers, thermostats, pressure-guages, vacuum-
gauges, automatism, etc.) with possible setup.

TO CHECK the hydraulic plant with check of the watertight and elimination of possible leaks.

TO CHECK and clean the filters.

TO CHECK the electric plant with relative connections.

TO VERIFY the safety systems, safety valves, seal piston doors, clean the seat of doors
gasket.

TO REPLACE in case, the gaskets to the cock.

TO CHECK probes and thermoresistances.

TO CHECK and in case lubricate the mechanical motion parts.

TO CHECK the electric steam generator with disassembly of the heating resistances and
removal of calcareous deposits.

TO CHECK air compressor and possible restoration of the oil level.

TO CHECK pilot valves and replace ring or sealing ring

4.4 CLEANING AUTOCLAVE

CLEANING OF THE STERILIZATION CHAMBER: to execute with the following modalities:


- When the chamber is in normal conditions wash with hot water and neutral shampooing; do not use
sharped tools, re-wash.

- When the chamber has superficial store up of depositd wash with hot water and non corrosive or
neutral detergents. Donot use sharped tools. Re-wash.

- When the chamber has deposits strongly encrusted as in the first case and apply a pickling agent
past present in the markett following the instructions of the manufactures. Keep the paste in contact
with the surface to clean, according, of the intensity of the action required, so remove it with water
meticulously, especially in the corners. Do not use sharped tools. Repat the washes.

CLEAN PANELS: use a soft cloth a non aggressive solution for stainless steel.

CLEAN GASKETS DOOR/S: use alcohol and talcum powder.

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4.5 REPLACEMENT OR CLEANING OF THE DOOR GASKET

For a right working of the sterilizer is opportune to execute periodically the cleaning and
replacement of the seal gasket of the doors.
Per questa operazione procedere nel modo seguente:
1- extract the gasket from the seat using non sharped tools
2- clean the gasket with alcohol and strew it with talcum powder
3- clean the seat of the gasket with a cloth imbued of alcohol and a non sharped tool
4- to sprinke a spray silicone (the same type used for surgical instruments) in the seat for t
make the insertion of it.
5- insert again with the hands the gasket.

4.6 – REPLACEMENT OF THE BACTERIOLOGICAL FILTER OF THE AIR

For the replacement of the bacteriological filter of the air proceed in the following way:
1-open the door of the sterilization chamber loading side
2- open the panel of the modulo using the key
3- remove the block screw of the frontal panel laterally placed
4- open the frontal panel of the sterilization chamber
5- unscrew the bacteriological filter of the air placed over the sterilization chamber with
suitable equipment
6- assemble the new filter
7- close the sterilizer executing the operation on the contrary

4.7 - REPLACEMENT OF THE STEAM FILTER

CAUTION close the steam before to proceed to the replacement

1- switch off the autoclave acting on the push-button n 4 picture 2


1- open the door of the sterilization chamber load side
2- open the panel of the modulo using the key
3- remove the block screw of the frontal panel laterally placed
4- open the frontal panel of the sterilization chamber
5- close the cock steam arrival
6- loosen the 12 screws placed on the flange of the container of the filter.

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CAUTION at the moment of the closure of the cock of steam arrival the
stretch of tube until the pneumatic valve stays under pressure. If it
proceeds immediately at the replacement of the filter loosing the screws
await that the steam go out from the tube through the flange, so use due
caution. If we await the cooling of the filter before to proceed at the
replacement, the part of the tubing that was under pressure can stay under
vacuum for the condensation, so also removing the screws of block the
flange cannot move. Open slowly the cock of steam arrival to compensate
the loss of pressure of the tubing.

7- unscrew the 12 screws placed on the flange of the container of the filter
8- extract the cartridge and replaced it or in case clean it with compressed air or anti
incrustator substances
9- assemble again the screws on the flange
10- open again the steam and verify the seal of the flange
11- close the sterilizer executing the operation on the contrary

4.8 - CLEANING OF THE FILTER DRAIN CHAMBER

1- open the door of th esterilization chamber on the load side


2- open the panel of the module using the key
3- open the frontal panel of the sterilization chamber
4- unscrew the cartridge of the filter “Y” placed to the drain chamber under the steriluization
chamber. The cartridge is sideways that the cylindrical container.
5- clean the cartridge using compressed air or anti incrustator substances
6- assemble the cartridge on body
7- close the sterilizer executing the operations on the contrary

4.9 - CLEANING OF THE FILTER OF COMPRESSED AIR

CAUTION close the compressed air before to proceed to the cleaning

1- open the panel of the modulo using the key


2- disassemble the container of the filter of the compressed air placed in the bottom than to
the steam generator
3- clean the filter with the compressed air removing possible deposits
4- put again the cartridge in the container and screw again the same to the body of the filter
5- open again the compressed air
6- close with the key the panel of the modulo

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4.10 - REPLACEMENT FUSES

CAUTION The autoclave has not a general switch. Before to execute


electric maintenances switch off the voltage upstream of the same
autoclave.

The fuses in the electric board are inserted on fuse carriers. Proceed to the replacement
following this procedure:

1- Switch off the autoclave.


2- Open the panel of the module using the key
3- Open the electric board with the suitable key
4- Localize the fuse to reset. The amperage is described in the electric diagram.
5- Open the fuse carrier acting on the tab “a” from the top toward the bottom.
6- Remove the failed fuse and insert again the new one.
7- Close the fuse carrier acting on the tab “A” from the bottom toward the top.
8- Close the electric board
9- Close the panel of the module

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4.11 - RESET THERMICS

CAUTION The autoclave has not a general switch. Before to execute


electric maintenances switch off the voltage upstream of the same
autoclave.

The thermic protections of the motors in the electric board can be resetted following the
procedure below described:

1- Switch off the autoclave.


2- Open the panel of the module using the key
3- Open the electric board with the suitable key
4- Localize the thermic to reset (the red push-button “START” is not pushed)
5- Push the red push-button “START”
6- Close the electric board
7- Close the panel of the module

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4.12 REPLACEMENT BATTERIES


The CPU CQM1 inside the autoclave has a battery 3G2A9-BAT08. In normal conditions, the duration
is about five years. When the voltage of the battery start to drop it causes an error conditions,
visualized from the display.

ATTENZIONE replace the battery within one week from the signaling

Use the following procedure to replace the battery. This procedure must be finished within five
minutes from the switch off of the autoclave to ensure the backup of the memory.
10- Switch off the autoclave. If the autoclave is switched off, switch it on for at least one minute and
than switch it off again.
11- Open the module of the panel using the key
12- Open the electric board with the suitable key
13- Open the compartment in the upper left of the CPU and carefully draw out the battey.
14- Remove the battery connector.
15- Connect the new battery, place it into the compartment and close the cover.
16- Close the electric board and the module of the panel.

WARNING Never short-circuit the battery terminals; never charge the


batter; never disassemble the battery and never heat or incinerate the
battery. Doing any of these may cause the battery to leak, burn, or
rupturing resulting in injury, fire, and possible loss of life or property.
CAUTION The autoclave has not a general switch. Before to
execute electric maintenances switch off the voltage upstream of
the same autoclave.

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4.13 PRINTER

4.13.1 REPLACING THE PAPER ROLL (PIC.16)

To replace the paper roll follow the instructions before:


1. Open the orinter frontal panel and place the paper roll in his right position and sense of rotation.
2. Take the top edge of the paper and insert it in the printing mouth of the printer.
3. push the FEED button on the printer to charge the paper through the printing rolls.
4. Inserit the top edge of the paper in the front panel hole and close the printer.

4.13.2 REPLACING THE INKED ROLL (PIC.16)

To replace the inked roll of the printer follow the instruction before:
1. Open the frontal panel of the printer and remove the exausted ink cartridge, by the PUSH button
2. Insert the new inked roll in the same position of the old one
3. Stretch the roll operating on the knurled button and close the panel.

PIC.16

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4.14 HINTS FOR QUICK REPAIRING LIST

INCONVENIENT PROBABLE CAUSE ACTIONS TO TAKE

Jacket does not go in Power failure Check the current arrival to remote contropl switch and the relative
pressure contacts, fuses in the electric board, dvice of water minimum level (if
there isn’t resistors switch-off)
Resistors of generator burnt Check and/or replace
Shortage of compressed air Check the arrival from network or compressor
Insufficient vacuum Water shortage in the network Check the arrival from network or pump
Pneumatic valve PV6 is leaking Clean the seat or replace the valve
Pneumatic valve PV7 (feeding water Check the pilot electro-valve, in case replace the coil
pump) is leaking
Non return valve aeration N4 is As above
leaking
Pneumatic valve PV8 is leaking As above
The motor of vacuum pump is tripped Check the pump.
Door/s gasket Check the condition of the gasket and in case clean it and insert it
again in the seat.
Low steam pressure in Shortage of water in the generator ** Check the level
chamber
Cock steam arrival of chamber Check and in case adjust the opening turning slowly the handle of
the cock
Resistors of the generator burnt ** Check and/or replace
Pneumatic valve PV20 is leaking Check and in case replace th gasket (or valve)
Temperature probe defective Check the wear and tear of the cable; replace it
Steam escape from the door Check the gasket, replace it if it is worn
Condensate residuals in Pneumatic valve PV9 does not open Clean the seat of the valve; if necessary replace the gasket or the
chamber at the end of valve
the cycle
Cock condensate drain chamber RC9 Check and in case clean away deposits
obstructed
Other causes: see insufficient See: insufficient vacuum
vacuum
Pump is noisy in the Cock anticavitation pump RE6 Check and in case clean; adjust if necessary the opening
vacuum phase obstructed or out of calibration
Water shortage in the network Check the arrival.
DO NOT USE THE AUTOCLAVE WITHOUT WATER
The vacuum pump does Thermic of the pump QF1 tripped, Check the motor of the vacuum pump, verify that there is not
not start resistance to the rotation, if necessary, push the push-button of the
thermic, inside of the electric board restorating the contacts.
The pump load water Thermic QF2 is tripped, motor burnt; Search the cause of the failure, restore the contacts pushing the
does not start pump blocked push-button of the thermic in the electric board, or replace the fuse.
Bowie & Dick Test Loss of vacuum Check the cock condensate drain RC9; this cock must not be
unsatisfactory tampered. Ensure that the condensate escape and therefore it is not
obstructed.

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AUTOCLAVE SERIE 3000

REDUCER FILTER

ELECTRIC BOARD
AIR FILTER

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AUTOCLAVE SERIE 3600

DISCHARGE FILTER REDUCE FILTERS

ELECTRIC BOARD AIR FILTER

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AUTOCLAVE SERIE 400

ELECTRIC BOARD DISCHARGE FILTERS

AIR FILTER REDUCER FILTER

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AUTOCLAVE SERIE 420

ELECTRIC BOARD DISCHARGE FILTER

AIR FILTER REDUCER FILTERS

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AUTOCLAVE SERIES 640

AIR FILTER DISCHARGE FILTER

REDUCER FILTERS STEAM FILTER

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AUTOCLAVES SERIES 1000-1350-1400


REDUCER FILTERS STEAM FILTER

AIR FILTER DISCHARGE FILTER

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AUTOCLAVES SERIES 1000-1350-1400

- FILTERS GROUP - ELECTRIC BOARD

STEAM FILTER FUSES


BACTERIOLOGICAL AIR FILTERS THERMICS
REDUCER FILTERS

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AUTOCLAVES SERIES 1000-1350-1400

DISCHARGE CHAMBER FILTER

ELECTROVALVE / PRESSURE-SWITCH ZONE

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5.0 ACCESSORIES
5.1 MAGNETIC WATER SOFTENER
The use of this accessory is advised for the treatment of network water that feed the autoclave. On
water circuit it avoids, in the new installations, the formation of calcareous deposits and cause into the
existing installations the progressive disintegratin of calcareous deposits present. Furthermore it
avoids the periodic and indispensable maintenance operations for the elimination of the calcareous
deposits and it protects the internal of tubes from the formation of rust.
The best efficiency of the unit obtains in presence of the foIlowing operation conditions:
- max. pressure: 20 Atm
- max. temperature: 250°C
-degree of Ph of water: 7÷9
-optimal speed: 1÷2 m/sec.
-capacity: there are no limits
Technical informations
Water softener must be periodically submitted to a check that consists exclusively to work the clean of
the internal nucleus that can be with the time, coated by film or metallic particle that make them less
effective to run.
For the clean cannot be use absolutely wire brushes, that makes immediately unusable the unit, but it
must intervene with solutions that can be required to the supplier or, in laternative, use lemon-juice or
vinegar absorbing a cloth and make it slide on the internal nucleus. This action will remove whether
the plate or possible ferrous deposits that will be stored in the time.
For every other operation that does not concernes as above said, please contact the Techncial
Assistance Service of Supplier that will provide tto send a Technician.

5.2 ELECTRIC AIR COMPRESSOR


The electric air compressor is necessary in absence of network compressed air for feeding of
pneumatic plant; it has a power of 0,5%HP and placed inside the cabinet of the autoclave.
Avvises for a good functionality
a) Periodically remove (if possible every week-end) the condensate that has collected in the tank, to
empty the tank.
b) For to do this it needs to put in pressure the tank, remove the plug from the outlet to take the
compressor where water output does not damage the floor, incline ligthly the compressor forward and
unscrew the suitable cock placed in the bottom on the tank.
c) Periodic controls (every week) of the oil level, can be easily executed through the level glass (if
necessary top up the oil).
d) The compressor is equipped with a motor protection that stops it automatically in case of power
overload or when the temperature of the motorcompressor reaches the value of 100÷110°C.

e) If this event should verify during the normal use, put the switch in “OFF” position and let cool it
for about 30 minutes.
f) The motorprotector will active again automatically the contact when the temperature will reach
a value of about 60÷70°C.
g) Switch ON again and check that all is ok.
h) Always use with the compressor on a flat surface
i) Do not check or repair the compressor when it is connected to a power source.

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For execute the topping up of the oil


-remove the rubber plug placed on the suction pipe, draw out from the nylon bag the suction filter
and the spout, screw this one on the supplied bottle of oil.
-so proceed to the introduction of the oil through the suction tube, until to reach the optimal level, as
indicated in the plate: Keep the oil that will remain in the bottle for further topping up.
-so insert with a simple pressure on the tube, the suction filter; after the introduction is necessary do
not overturn or incline a lot the compressor for avoid overflow of oil.
-Montly execute the recover of the oil in the filetr opening the suitable cock,with the compressor in
function, for about 1 minute.

NEVER USE DIFFERENT OILS FROM THAT RECOMMENDED BY THE SUPPLIER.

5.3 GRAPHIC RECORDER

Remove the chassis.

5.3.1 – Installation of the paper.

1- remove the support of the paper.


2- put the support on the table with flat plate on the bottom and the rollwith stakes toward you.
3- turn the upper spindle for the unrolling of the roll of paper toward you overcome the pressure of the
springs and remove it from the support. Insert the spindle in the new roll of paper with holed from the
side of the flange.
4- insert the spindle with paper into the support with the flange on the left side inserting both the
extermities of the spindle hook them into the groove. The spinkle is kept fixed by the springs.
5- pull the extremity of the paper keep the support on the table, for about 300 mm. Toward you above
the roll with stakes after to have made pass it between the roll with stakes and the nearest shaft.
6- to make on line the paper in orthogonal way on the roll with stakes that go out from the holes on the
left-side of the paper and from the groove on the right-side.
7- keep away lightly the support and pass the extremity of the paper into the groove of the recover roll
after to have passed it on the front plate and on the shaft. With the extremity of the paper in to the
groove and centered it on the roll of recover, recover the excess of paper turning the knurled disk on
the roll of recover.

5.3.2 - Unrolling of the paper on the front.


When the paper must not be re-wrapped but turned on the front with the door of the recorder closed, it
can obtaiin removing the internal bottom plate of the door. For the loading of the package-paper to
refer to the diagram reported on the package-container of the paper support.

5.3.3 Assembling of the pens


Open the door of the recorder and extract the chassis. Remove the screw that fixes the supports of the
pen. The supports of the pens can be turned, one at a time from the left or right sides of the frame
pushing until to the stop position . With the support in this position, the pens can be easly inserted.
The pens supplied with the instrument are cartridges to loose with capillary tube fibre point. The red
pens, blue and green are respectively for Channel 1 (lower frame), Channel 2 (frame in centre) and
Channel 3 (upper frame). Make attention do not contaminate the writng point with the sweat of the
hands. Before to assemble the pen ensure that the rubber plugs put in protection of the writing point
and on the back side of the cartridge are removed. Starting with the more internal frame, place the
indicator of the pen in front of the scale. To thread the conical pivot in the hole of the fixed side of the
trolley ensure yourselves that the samll spring is placed in front of the step on the side of the pivots. To
load the spring of the pen-trolley and to thread the other conical pivot in the hole sideways of the
spring.

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5.3.4 - Pressure of the pen


The pen should swingwithout stop it and to be sufficiently loaded from the spring to obtain a pressure
from 5 to 10 grams on the paper with the frame completely closed.Non sufficient pressure could cause
the breaking in the trace of the pen. An higher pressure can cause a premature wear and tear of the
pen with widest trace and a short life of the cartridge. Close again the frames one at a time ensure that
the tooth fit it in positively and lock these with the fixing screws.

5.3.5 - Settlement of the writing point.


With the support of the paper fixed in position to verify the the point of the pen remains lightly laid on
the paper. To move manually the trolley of the pen through a scale to ensure that all pens to cross
each other. If this condition does not verify arrange again the capillaries of the pens fold them lightly.

5.3.6 - Control of the scales, indicators and capillaries pens


Over the instruments single-pen, move manually the trolley of the pen until that the trace coincides
with the zero on the paper. In this position verify that the indicators coincides with the zero on the
scale. If necessary position again the scale because they correspond. For the instruments 2 or 3 pens
proceed as above for the lower pen so to align the intermediate and upper scale with the lower.
Position manually the trolleys of the pens in order that the indicators are aligned with zero of the
scales. To verify that the position of the writing points coincides with the zero on the paper. If the pens
must be adjusted, fold them softly.
To move manually the trolleys of the pens and ensure that the indicators move them under zero anf
over the 100% of the scale of about 3 mm. The point of the pens never must not enter into the slots
right-side of the paper.

5.3.7- Initial lubrication


Every recorder is lubricated before the shipment and so the lubrication is not requested if the
instrument is installed as soon as after the shipment of the factory.

5.4 COOLING OF DISCHARGES DEVICE


The device consents the control of the temperatures to the discharge of the sterilizer in fact all
fluids in discharge (condensate and water) pass through this container in which mix them to
cold water before to discharged. The temperature of discharge can be selected by the pressure
gauge of control placed into the junction box. The temperature selected at the shipment of the
sterilizer is of 60°C.

5.5 MODULAR BASKET


This kind of container is used to contain material inside bags or packed with medicinal paper.

5.6 - CONTAINERS
This kind of the container is used to pack kit of surgical instruments, clothes, gauzes, rubber etc. The
conservation of the sterilized material is of long life, but it is necessary the replacement of the filters
respecting the prescriptions of the suppliers.

5.7 - TRAY
This kind of container is used to contain different materials but does not guarantee the mantaining of
the material if it is not opportunely packed or inserted into the containers.

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6.0 STERILIZATION MANAGEMENT


6.1 FORMALDEHYDE USE
In the process of the sterilization law temperature is possible to utilize as sterilizing agent the
formaldehyde that in particular condition to garantee the efficacy of the process.
The quantity of the formaldehyde used is in fuction of the capacity of the chamber of sterilization and
of the temperature of sterilization and precisely:

Chamber
Capacity Cycle 55°C Cycle 65°C Cycle 75°C
148 lt 6 gr. 6 gr. 7 gr.
Serie 400
211 lt 7 gr. 8 gr. 9 gr.
142 lt 5 gr. 6 gr. 7 gr.
Serie 420 203 lt 7 gr. 8 gr. 9 gr.
253 lt 10 gr. 11 gr. 12 gr.
305 lt 12 gr. 14 gr. 16 gr.
435 lt 17 gr. 19 gr. 21 gr.
Serie 640 545 lt 20 gr. 22 gr. 24 gr.
697 lt 25 gr. 28 gr. 31 gr.
827 lt 29 gr. 33 gr. 37 gr.
71 lt 2 gr. 3 gr. 4 gr.
Serie 3000
98 lt 3 gr. 4 gr. 5 gr.

Is possible to use solid formaldehyde by pastillies or grains.


The cycle of sterilization is completely automatic while for the loading the formaldehyde is introduce
manualy inside the special container.
All fases of the cycle of sterilization are controlled in safety up to the end of cycle.
The formaldehyde is sublimate in a special device and the will be introduce in the chamber of
sterilization; thise fase is attentively controlled to the equipment by detectors for to garantee the
presence the gas inside of the chamber of sterilization.
At the end of cycle will be issue a document where are showing all date, the graphic and the final
result.

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6.2 DESCRIPTION OF THE STANDARD FORMALDHEYDE CYCLE


This appendix describes the set of a standard formaldheyde cycle in all its steps.

6.2.1 STERILIZATION CYCLE AT 55°C

FASE 1 – VACUUM LEAK TEST


This fase is included to idividualize the possible hydraulic leakage before the injection of the
formaldheyde inside the chamber.
Standard set of fase 1
-Leak 13 mbar
-Set Vacuum -0850 mbar
-Heat 55°C
-Time 10min
-max Time 20min (before max time fase alarm)

FASE 2 – CONDITIONING
This fase is performed to pretreat the material inside the chamber before the sterilization. It
makes a customizable number of pulsing of vacuum and steam under atmosferic pressure.
Reached the set every pulsation (min and max), the process mantain it for the time of 1 min.
Standard set of fase 2
-Set1 (min) -850 mbar
-Set2 (max) -840 mbar
-max Time 120 min (before max time fase alarm)
-Heat 55°C
-N. of repeatition 5

FASE 3 – HEATING
This fase start just concluded the last vacuum pulsation, and it serves to reach the sterilization
set temperature.
Standard set of fase 3
-heat 55°C
-°C/min 000.0
-max time 999 (before max time fase alarm)

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FASE 4 – STERILIZATION
This fase mantain the temperature for a customizable period of time.
Standard set of fase 4
-Temperature 55°C
-Time 120 min
-Attribute F0 mode non activated

FASE 5 – WASHING
After the sterilization fase this cycle perform a long vacuum for 5 min, then it start with a
customizable number of pulsing pressure of vacuum and steam under atmosferic pressure.
Reached the set of every pulsation (min and max), the process mantain it for the time of 1 min.
After the last vacuum it start with a series of pulsing of vacuum and areation under atmosferic
pressure. The number of repetition is not customizable by touch screen.
Reached the set of every pulsation (min and max), the process mantain it for the time of 30sec.
Standard set of fase 5
(Washing fase with vacuum and steam)
-Set1 (min) -850 mbar
-Set2 (max) -840 mbar
-Max time 999min (before max time fase alarm)
-Heat 55°C
-N. of repeatition 15
(Washing fase with vacuum and air)
-Set1 (min) -850 mbar
-Set2 (max) -120 mbar

FASE 6 – DRYING
After the washing fase this cycle perform a final long vacuum for 5min. then the cycle end with
areation to atmosferic pressure.
Standard set of fase 6
-Vacuum -850 mbar
-heat 55°C
-Time 5min

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6.2.2 STERILIZATION CYCLE AT 65°C

FASE 1 – VACUUM LEAK TEST


This fase is included to idividualize the possible hydraulic leakage before the injection of the
formaldheyde inside the chamber.
Standard set of fase 1
-Leak 13 mbar
-Set Vacuum -0850 mbar
-Heat 65°C
-Time 10min
-max Time 20min (before max time fase alarm)

FASE 2 – CONDITIONING
This fase is performed to pretreat the material inside the chamber before the sterilization. It
makes a customizable number of pulsing of vacuum and steam under atmosferic pressure.
Reached the set every pulsation (min and max), the process mantain it for the time of 1 min.
Standard set of fase 2
-Set1 (min) -850 mbar
-Set2 (max) -840 mbar
-max Time 120 min (before max time fase alarm)
-Heat 65°C
-N. of repeatition 5

FASE 3 – HEATING
This fase start just concluded the last vacuum pulsation, and it serves to reach the sterilization
set temperature.
Standard set of fase 3
-heat 65°C
-°C/min 000.0
-max time 999 (before max time fase alarm)

FASE 4 – STERILIZATION
This fase mantain the temperature for a customizable period of time.
Standard set of fase 4
-Temperature 65°C
-Time 120 min
-Attribute F0 mode non activated

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FASE 5 – WASHING
After the sterilization fase this cycle perform a long vacuum for 5 min, then it start with a
customizable number of pulsing pressure of vacuum and steam under atmosferic pressure.
Reached the set of every pulsation (min and max), the process mantain it for the time of 1 min.
After the last vacuum it start with a series of pulsing of vacuum and areation under atmosferic
pressure. The number of repetition is not customizable by touch screen.
Reached the set of every pulsation (min and max), the process mantain it for the time of
30sec.
Standard set of fase 5
(Washing fase with vacuum and steam)
-Set1 (min) -850 mbar
-Set2 (max) -840 mbar
-Max time 999min (before max time fase alarm)
-Heat 65°C
-N. of repeatition 15
(Washing fase with vacuum and air)
-Set1 (min) -850 mbar
-Set2 (max) -120 mbar

FASE 6 – DRYING
After the washing fase this cycle perform a final long vacuum for 5min. then the cycle end with
areation to atmosferic pressure.
Standard set of fase 6
-Vacuum -850 mbar
-heat 65°C
-Time 5min

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6.2.3 STERILIZATION CYCLE AT 75°C

FASE 1 – VACUUM LEAK TEST


This fase is included to idividualize the possible hydraulic leakage before the injection of the
formaldheyde inside the chamber.
Standard set of fase 1
-Leak 13 mbar
-Set Vacuum -0850 mbar
-Heat 75°C
-Time 10min
-max Time 20min (before max time fase alarm)

FASE 2 – CONDITIONING
This fase is performed to pretreat the material inside the chamber before the sterilization. It
makes a customizable number of pulsing of vacuum and steam under atmosferic pressure.
Reached the set every pulsation (min and max), the process mantain it for the time of 1 min.
Standard set of fase 2
-Set1 (min) -850 mbar
-Set2 (max) -840 mbar
-max Time 20 min (before max time fase alarm)
-Heat 55°C
-N. of repeatition 5

FASE 3 – HEATING
This fase start just concluded the last vacuum pulsation, and it serves to reach the sterilization
set temperature.
Standard set of fase 3
-heat 75°C
-°C/min 000.0
-max time 999 (before max time fase alarm)

FASE 4 – STERILIZATION
This fase mantain the temperature for a customizable period of time.
Standard set of fase 4
-Temperature 75°C
-Time 90 min
-Attribute F0 mode non activated

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FASE 5 – WASHING
After the sterilization fase this cycle perform a long vacuum for 5 min, then it start with a
customizable number of pulsing pressure of vacuum and steam under atmosferic pressure.
Reached the set of every pulsation (min and max), the process mantain it for the time of 1 min.
After the last vacuum it start with a series of pulsing of vacuum and areation under atmosferic
pressure. The number of repetition is not customizable by touch screen.
Reached the set of every pulsation (min and max), the process mantain it for the time of
30sec.
Standard set of fase 5
(Washing fase with vacuum and steam)
-Set1 (min) -850 mbar
-Set2 (max) -840 mbar
-Max time 999min (before max time fase alarm)
-Heat 75°C
-N. of repeatition 15
(Washing fase with vacuum and air)
-Set1 (min) -850 mbar
-Set2 (max) -120 mbar

FASE 6 – DRYING
After the washing fase this cycle perform a final long vacuum for 5min. then the cycle end with
areation to atmosferic pressure.
Standard set of fase 6
-Vacuum -850 mbar
-heat 75°C
-Time 5min

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