Manual AUTOCLAVE ESPASMA

CISA S.p.A. - Manual of Use and Maintenance - Version 1.
3/07
STERILIZING AUTOCLAVES
PLASMA
MANUAL OF USE AND MAINTENANCE
CISA S.p.A.
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
0123
Cod.UM–Gb–SPS–2.0/07 T o t a l P a g e s n . 112 + A t t a c h m e n t s
CISA S.p.A. - Manual of Use and Maintenance - Version 1.3/07
INDEX
INTRODUCTION ................................................................... 5
NOTICES FOR SAFETY ..................................................... 6
TECHNICAL DESCRIPTION ............................................ 10
1.0 GENERAL INFORMATIONS..................................... 14
1.1 - WARRANTY ...........................................................................................................................................14
1.2 - OTHER CONDITIONS ...............................................................................................................................14
1.3 - RESPONSABILITY .....................................................................................................................................15
1.4 - TRAINING ..............................................................................................................................................16
1.5 - FREQUENTLY ASKED QUESTIONS ...............................................................................................................17
1.6 - KIND OF MATERIALS ...............................................................................................................................18
1.7 – WASHING, CLEANING AND PACKAGING.................................................................................................20
1.8 – LOAD AND UNLOADING OF THE CHAMBER ..............................................................................................22
1.9 - RELEASE CRITERIA ..................................................................................................................................23
1.10 - CARTRIDGES .......................................................................................................................................24
1.11 - IN CASE OF INVALID CYCLE ...................................................................................................................25
1.12 – STERILIZATION CYCLES..........................................................................................................................26
1.13 - SAFETY SYSTEMS ...................................................................................................................................30
1.14 - SET-POINT SAFETY SYSTEMS AND FUNCTIONALITY ......................................................................................31
1.15 - OPERATOR CODES ..............................................................................................................................32
1.16 ALARMS................................................................................................................................................34
2.0 MANAGEMENT OF THE AUTOCLAVE ..................... 37

2.1 - PRELIMINARY OPERATIONS.............................................................................................................37
2.2 - STARTING OF THE AUTOCLAVE.......................................................................................................37
2.3 - MAIN MENU ......................................................................................................................................38
2.4 - PROCEDURES FOR THE STARTING OF A CYCLE............................................................................39
2.5 - INSERTION OF LOT CODE ................................................................................................................41
2.6 - INSERTION OPERATOR CODE .........................................................................................................42
2.7 - CONFIRMATION START OF THE CYCLE ..........................................................................................42
2.8 – PRINT OF LABELS .............................................................................................................................44
2.9 - VERIFICATION CONDITIONS TO PROCEED AT THE START OF THE CYCLE..................................44
2.10 - PHASE IN COURSE ..........................................................................................................................45
2.11 - MANUAL WORKING.......................................................................................................................47
2.12 - CANCELLATION OF THE CYCLE ...................................................................................................47
2.13- UNDERMENU OF SELECTION ..........................................................................................................48
2.14- SET-POINT PAGE ..............................................................................................................................50
2.15 - SINOPTIC .........................................................................................................................................51
2.17 - PAGE DIAGRAM ............................................................................................................................52
2.18 - ALARMS PAGE................................................................................................................................53
2.18.1 - ALARMS HISTORY PAGE.........................................................................................................54
2.19 - END OF THE CYCLE ........................................................................................................................54
2.20 - PRINTS ..............................................................................................................................................57
2.20 - LOADING/UNLOADING OPERATIONS.........................................................................................61
2.21 - LABEL REPRINTING..........................................................................................................................61
Autoclaves CISA Pag.2

3.0 TECHNICAL FUNCTIONS ........................................ 62

3.1 - DATA INSERTION...............................................................................................................................62
3.1.1 - NUMERICAL DATA INSERTION ...........................................................................................................62
3.1.2 - INSERT THE NUMERICAL DATA...........................................................................................................63
3.2 - PROCEDURE FOR THE MANAGEMENT OF THE TECHNICAL PARAMETERS ................................64
3.3 - ACCESS TO MENU............................................................................................................................65
3.4 - CHANGE DATE AND HOUR.............................................................................................................67
3.5 - MODIFICATION OF THE PARAMETERS IN THE OPEN CYCLES......................................................68
3.6 - MODIFICATION OF THE PARAMETERS OF CYCLE.........................................................................69
3.7 - MODIFICATION OF PARAMETERS RELATIVE TO THE MAINTENANCE .........................................75
3.8 - MENU PARAMETER OF PRINT ..........................................................................................................76
3.9 - MENU’ GENERAL PARAMETER ........................................................................................................76
3.10 - MODIFICATION OF THE STANDARD CYCLES ..............................................................................79
3.10.1 - STANDARD CYCLE CONFIGURATION.......................................................................................81
3.11 - CALIBRATION..................................................................................................................................82
3.12 - MANUAL ACTIVATION OF THE OUTPUTS .....................................................................................88
3.14 - OTHER PARAMETERS ......................................................................................................................92
4.0 MAINTENANCE ...................................................... 95

4.1 GENERAL INFORMATIONS ABOUT MAINTENANCE .......................................................................95
4.2 - PROGRAMMED MAINTENANCE.....................................................................................................95
4.3 - FURTHER USEFUL MAINTENANCE ADVICES ...................................................................................98
4.4 - CLEANING AUTOCLAVE..................................................................................................................98
4.5 - REPLACEMENT OR CLEANING OF THE DOOR GASKET ...............................................................98
4.6 - REPLACEMENT OF THE BACTERIOLOGICAL FILTER OF THE AIR .................................................99
4.7 - CLEANING OF THE FILTER DRAIN CHAMBER............................................................................. 100
4.8 - CLEANING OF THE FILTER OF COMPRESSED AIR...................................................................... 100
4.9 - REPLACEMENT FUSES ................................................................................................................... 101
4.10 - RESET THERMICS ......................................................................................................................... 102
4.11 - REPLACEMENT BATTERIES ........................................................................................................... 102
4.12 - PRINTER......................................................................................................................................... 103
4.12.1 - REPLACING THE PAPER ROLL ............................................................................................. 103
4.12.2 - REPLACING THE INKED ROLL (PIC.15)............................................................................... 103
4.13 – EXTRAORDINARY MAINTENANCE............................................................................................. 104
4.14 - TROUBLESHOOTING .................................................................................................................... 104
5.0 ACCESSORIES ....................................................... 105

5.1 - ELECTRIC AIR COMPRESSOR ....................................................................................................... 105
5.2 - GRAPHIC RECORDER ................................................................................................................... 105
5.2.1 - INSTALLATION OF THE PAPER. ........................................................................................................ 105
5.2.2 - UNROLLING OF THE PAPER ON THE FRONT. ..................................................................................... 107
5.2.3 - ASSEMBLING OF THE PENS. .......................................................................................................... 107
5.2.4 - PRESSURE OF THE PEN. ................................................................................................................. 107
5.2.5 - SETTLEMENT OF THE WRITING POINT................................................................................................ 107
5.2.6 - CONTROL OF THE SCALES, INDICATORS AND CAPILLARIES PENS. ...................................................... 107
5.2.7 - INITIAL LUBRICATION. ................................................................................................................... 107
5.3 - MODULAR BASKET......................................................................................................................... 108
5.4 - CONTAINERS.................................................................................................................................. 108
TECHNICAL APPENDIX ...................................................... 109

INDEX OF THE PICTURES

Pic. 1 ...........................................................................................................................................11
Pic. 2 ...........................................................................................................................................12
Pic. 3 ...........................................................................................................................................13
Pic. 4 .........................................................................................................................................104
ENCLOSEDS
ELECTRIC DIAGRAM
HYDRAULIC DIAGRAM
PNEUMATIC DIAGRAM

Introduction
CISA SPS sterilizer is a multipurpose sterilizer made by CISA S.p.A..
The principle of sterilization of this device is based on the chemical reaction of an oxidizing
agent containing hydrogen peroxide and on its subsequent degradation by means of plasma.
The oxidizing agent in the form of vapour ensures the quick and effective sterilization of many
pieces of equipment and materials. All the stages of the sterilization cycle take place in a low-
temperature and dry place, consequently CISA SPS is appropriate to sterilize those pieces of
equipment which are steam and humidity sensitive both on metallic and on non-metallic
equipment. Two separate cycles have been developed for CISA SPS. Cycle n.1 is advisable for
all those devices which are compatible and which have no narrow holes whereas cycle n.2 is
advisable for those devices having narrow holes and which are limited to the right functioning of
the sterilizer. (See chapter 1)
NOT ES ON THE USE OF THIS MANUAL

The following pages contain basic information necessary for the safe and effective functioning of
CISA SPS sterilizer. This manual is for professional users in the sterilization field and for those
technicians qualified for the ordinary maintenance and, partially, for the extraordinary
maintenance of sterilizers. Please read carefully the section on safety warnings
DEST INAT ION OF USE
The autoclaves of the CISA SPS series are used to sterilize all those medical pieces of
equipment which are compatible with the specifications herebelow described.
This equipment is a Medical Device according to Directive 93/42 EEC concerning Medical
Devices.

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. The list herebelow records the
most important warnings, which will anyhow be repeated in the following chapters. Other
specific warnings will be found in their respective chapters
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”
The “WARNING” sign is for specific information on the right use

and on maintenance of CISA SPS
WARNING!
The standard cycles setted on the machine are validated,
therefore its possible modification is forbidden if not fully re-
validated by specialized staff of CISA, 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.
WARNING
Do not try to sterilize items or materials which do not comply with
the standards set out in this manual. Please read the
manufacturer’s instructions to see whether a certain item can be
sterilized with this unit.
WARNING
Use your Personnel Protection equipment as glasses, facial shield
and gloves when you work this unit and when you are handling
the SPS cartridge which contains concentrated hydrogen
peroxide.

WARNING!
The cartridges in CISA SPS contain concentrated hydrogen
peroxide, which is a powerful oxidizing agent. Concentrated
hydrogen peroxide is harmful for your skin, eyes, nose, throat,
lungs and gastrointestinal tract. Direct contact with your skin can
cause serious irritation. In case of contact rinse immediately with
abundant water. If symptoms are serious or persist see a doctor
immediately. Direct contact with your eyes can damage tissues
irreversibly. In case of contact with your eyes rinse immediately
with abundant water and see an ophthalmologist right away. The
inhaling of vapours can seriously irritate lungs, throat and nose. If
you inhale vapours go outdoors, breathe fresh air and see a
doctor right away. Ingestion can be very dangerous. In this case
drink immediately lots of water to dilute. Do not provoke vomit.
See a doctor.
WARNING!
Do not try to open or tamper with the cartridges of CISA SPS, not
even after use. Throw away used-up cartridges following hospital
procedures for biological waste.
WARNING!
If at the end of a normal or irregular cycle the objects in the load
look humid, the oxidizing agent may be present in liquid form
Wear gloves when removing the objects from the chamber. Rub
them with a humid cloth.

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 use of unauthorized accessories may be dangerous and cause the

warranty to expire. The use of unauthorized accessories for
maintenance or repair may be harmful for people, causing expensive
damages or malfunctions in the unit thus terminating the warranty.
Electric power must be shut off before repairing or upkeeping the

sterilizer.
For any reason must not be modified or tampered all safety

devices of the sterilizer.
Sharp tools must not be used to insert or remove the seal gasket of the
chamber from the seat.
Do not clean the door of the chamber with abrasive chemicals. The
sterilizing chamber has a gasket to keep the chamber empty. Never use
coarse cleaning tools, such as metallic brushes or steel wool, on the
slot of the door or on the assembly of the chamber as this may damage
the gasket
Please do not tamper with used-up cartridges. In case you have to

handle a used-up cartridge, wear latex or vinyl gloves. Do not touch your
face or eyes with these gloves
The loading area of the sterilizer must be kept clean so as to avoid

dangerous conditions due to a slippery floor.

The front paneling of the sterilizer must be kept clean by means of a soft
cloth and chemicals which are not aggressive for stainless steel.
The chamber must be kept clean by means of a soft cloth and chemicals
that are not aggressive for stainless steel.
Dry all the items before loading them into the sterilization chamber.
Loads containing humidity in excess may cause the cycle to stop.
CISA SPS has two cycles. Cycle P1 is for those materials having no
narrow holes, and cycle P2 for those materials having narrow holes.
Metallic objects are not to touch the walls of the sterilization chamber .
A biological indicator must be used to check the sterilization cycle. In

case the cycle stops, a new biological indicator must be used to start the
following cycle.
Do not use biological indicators which are not specifically manufactured

for CISA SPS system.
Do not use products for the packaging which are not specifically
manufactured for CISA SPS system.

AUTOCLAVES CISA
TECHNICAL DESCRIPTION
Sterilization equipment
Model
CISA SPS 640
Technical data
Sps equipement dimension : 1700 x 1850 x 1094 mm (W x H x D)

Chamber dimension : 640 x 640 x 720 mm (300 lt)
Load volume : 630 x 630 x 500 mm (200 lt)
Weights : 1300 kg
Power : 10 kW , 400V 3ph+E
Plasma generator power: 2 Kw
Vacuum pump: 80 m3/hour
Pressure range : 1 x 103 ; 1 x 10-3 mbar
Temperature range: from enviroment up to 50°C
Hydraulic connection: Free drain ½”, Cold water ½” (potable) 20 lt/min, Compressed air
½” 15 Nl/min (Oil free, Water free)
Sound level: < 53 dB
Heat loss: 400W
Operator interface, Touch screen 8”
Automatic cycle with PLC and record on paper by panel printer (24 column dot impact)

AUTOCLAVE SERIE 640 SPS
Pic. 1
AUTOCLAVE SERIE CISA 640 SPS
FRONT VIEW
1 Sterilization chamber
2 Technical space / Module
3 Load side control panel
4 Compartment to insert cartridge

LOAD SIDE CONTROL PANEL LEGENDA
2
5
3
7
6
8 9
Pic. 2
1 Touch screen (Display) 7 Open door pushbutton (manual) /

2 ON / OFF pushbutton close door (automatic)
3 Stop cycle in course 8 Compressed air pressure
4 Emergency Pushbutton (Key-resetting) 9 Water pressure
5 Panel printer
6 Key -Selector for chamber discharge and
opening of doors

UNLOADING SIDE CONTROL PANEL LEGENDA

(DOUBLE DOOR EXECUTION)
7 10
11 12 13 14
Pic. 3
7 Closure door pushbutton 11 Led alarm

10 Opening door pushbutton 12 Led cycle in course
3 Stop cycle in course 13 Led end cycle
4 Emergency pushbutton (Key-resetting) 14 Led door closed
8 Compressed air pressure

1.0 GENERAL INFORMATIONS
1.1 - Warranty
The CISA SPS sterilizer is guaranteed as being free from faults in materials and
manpower for a period of 12 from the date of the testing and however not over 15 months
from the delivery if the device has been installed or as otherwise agreement, upkept and
used in the right way according to its destination of use. This warranty is exclusively for the
original buyer of the device and only if the device is used in the country where it was
originally sent to by CISA S.p.A. The warranty envisages only possible defects or flaws of
manufacture and of raw materials all those parts which can deteriorate for negligence or
wrong use of the equipment are not vouched for by the warranty .
This warranty will not be valid if people unauthorized by CISA S.p.A. try to or service the
equipment. Following an inspection by a CISA representative whenever,any part of the
unit appears to be faulty within the period of time mentioned above, and CISA
acknowledges the fault as due to faulty materials and/or manpower, CISA, at its choice,
will repair or replace the faulty parts for free. This warranty is not valid for repairs or
replacements due to external factors, among which the faulty electrical installation or
electrical or atmospheric troubles. CISA retains the right to repair or replace the device
where necessary in its own premises, in any authorized repair centre or in the buyer’s
premises The spare parts may be new or remanufactured. The faulty parts that have been
replaced under warranty will once again be owned by CISA
1.2 - Other conditions

Other conditions to be agreed with CISA S.p.A

1.3 - Responsability
The following chart lists the main activities that are necessary to ensure the right management
of the CISA SPS sterilizer and the respective responsabilities.
ID N° Activity Manufacturer End User

CISA spa
1 Installation Qualification (IQ) X X2
2 Operational Qualification (OQ) X X2
3 Performance Qualification (PQ) X1 X2
4 Basic course during the performance tests X1, D X2
and issuing of training documents
5 Complete course for users, issuing of X1, D X2
training documents and check of
effectiveness of training
6 Maintenance X1
7 Revalidation X1
8 Selection of compatible products X
9 Selection of load of compatible products X
10 Cleaning (washing) of devices to sterilize X
11 Packaging of devices to sterilize X
12 Preparation of load and unload X
13 Selection of cycle X
14 Check and approval of physical X
parameters of process
15 Check and approval of results of X
microbiological tests
16 Final release of load at the end of cycle X
17 Management of nonstandard cycles X
18 Management of nonstandard products X
Legenda
X : Direct responsability
X1 : Responsability pending approval of end user
X2 : Support and participation activity
D: Available documents issued by CISA to end user

1.4 - Training
To use CISA SPS in the right way it is best to be trained before usage. This training aims
at informing users of the procedures to follow when selecting the load, the packaging,
cycle type and unload of material.
There are two training courses; a basic one simply informs users of the right use of the
sterilizer, and a complete course, which comprises practical tests and a test to verify how
effective the training was.

1.5 - Frequently asked questions
Following are some of the most frequently asked questions by CISA SPS users .
Q: What kinds of devices can CISA SPS sterilize?
A: CISA SPS is a multipurpose sterilizer and is thus suitable for sterilizing most devices
which are commonly sterilized by means of traditional methods and those which are
sensitive to temperature and humidity. This sterilizer cannot sterilize devices made of
cellulose (such as paper products) and single-use devices . See the following chapters of
this manual and the instructions of the manufacturer of each device before insertion into
CISA SPES.
Q: Why is it impossible to sterilize devices made of cellulose with CISA SPS?
A: The vapour of the oxidizing agent is an element that is necessary to sterilize in the right
way. Paper, cotton and other materials made of cellulose would absorb the sterilizing
agent which, once absent, would make the sterilizing process inefficient.
Q: Is it possible to use cases such as containers and commonly used trays for the
distribution of material inside the chamber?
A: For the SPS sterilizer, CISA provides baskets in stainless steel grid series 300 to make
easier the penetration of gas and plasma previously tested and deemed suitable. Closed
trays or containers may interfere with the sterilization process and their functionality will
have to be previously tested. However, it is possible to use baskets similar to those
provided by CISA which do not prevent gas nor plasma to spread in the right way
Q: is it possible to insert the calculation sheet of an instrument and the sticker with the
expiration date?
A: These items are generally made of cellulose and are not admitted before sterilization. It
is advisable to stick the labels after sterilization or use envelope welders with integrated
printing .
Q: Is it necessary to pay particular attention to the placement of loads?
A: Loads must be placed in such a way as to allow the vapour of the oxidizing agent and
the gas plasma to reach all the devices inside the envelopes.
Q: How long does a sterilization cycle last?
A: The complete cycles normally about 120 minutes for cycles P1 and P2. The outgoing
material is ready for use after the evaluation of the following criteria:
1. results of the cycles parameters control performed by the SPS sterilization equipment
and recorded in the print out of each cycle,
2. evaluation of the sterility tests of the Biological Indicators
3. evaluation of the change of the colour of the chemical process indicator on the Tyvek®
Assuron and OPA15 film + PE 65 peel pouches used to envelope the medical devices
4. results of the visual inspection of the devices

Q: Where must the biological indicator be placed to test the cycle?
A: The biological indicator introduced into the challenge device (PCD) must be placed into
the lower grid next to one of the corners.
Q: Is it necessary to use chemical indicators inside the envelopes?
A: Yes, since the chemical indicator is generally used to identify those pouches
undergoing the sterilization process rather than those not processed. The pouches
provided by CISA for the SPS system already have a chemical indicator on them for the
use described above. It is possible, however, to insert inside the pouches some chemical
indicators to further verify the diffusion of the sterilizing agent.
1.6 - Kind of materials

This paragraph is a guide to materials and equipment that can be used with CISA SPS
sterilizer. This sterilizer uses a mix of hydrogen peroxide in gaseous state for objects
inside the sterilization chamber with no toxic residual. Although CISA SPS sterilizer
can safely sterilize many materials and pieces of equipment, there are some important
exceptions. Read carefully this paragraph to know the materials and devices that can
be easily loaded into this sterilizer .
CISA SPS is an all-purpose sterilizer suitable for sterilizing medical devices at low
temperature and, other than metallic and non metallic devices, is naturally suitable for
pieces of equipment which are sensitive to heat and humidity.
WARNING!
Do not try to sterilize items or materials not consistent with the
rules set out in this manual. Please read the instructions of the
manufacturer of this equipment to see whether it is possible to
sterilize a certain items with this unit.
Allowed materials:
Metals:
• Stainless steel series 300
• Aluminium series 6000
• Titanium
Non metals:
• Glass
• Ceramics
• Epoxy
Plastic materials:
• Polyethylene (LDPE)
• Polyvinyl Chloride (PVC)
• Chlorinated Polyvinyl Chloride (CVPC)
• Polystyrene
• Acrylonitrile Butadiene Styrene (ABS)
• Polyprophylene (PP)
• Teflon (PTFE, PFA, FEP)
• Polycarbonate
• Silicons
• Polytheretherketone (PEEK)
• Polymethylmethacrylaye (Acrylic)
• Polyethylene terephthalate (Polyester)
• Styrene-ethylene-butadiene-styrene (Kraton)
• Polychloroprene (Neoprene)
• Latex
• Nylon
This list is not complete. Only materials to be found in the most common pieces of
equipment are listed . All medical equipment must be treated according to the
manufacturers’ instructions. When in doubt, before loading any device inside CISA
SPS, read the instructions of the manufacturer of the equipment.
Not allowed items and materials:

• Any item that has not been properly washed, disinfected and packaged before
sterilization
• Any item that is not completely dry.
• Items or materials absorbing liquids.
• Items or materials containing cellulose, such as: cotton, paper or paperboard,
linen, towels, gauze sponges or any item containing wood pulp.
• Calculation sheets or labels for the date.
• Single-use items that are not recommended for resterilization by the
manufacturer.
• Prostheses that the manufacturer has not specifically recommended for
sterilization CISA SPS.
• Tools and equipment that cannot tolerate vacuum and are labeled for
sterilization methods by means of steam in conditions of gravity.
• Items whose structure makes surfaces stick one to the other unless a method
to keep the surfaces apart is envisaged.
• Equipment with inner parts, such as unsealed buffers, which cannot be dipped
and may be very difficult to clean
Materials:
• Liquids
• Powders
• Gel
• Fats
• Cellulose
• Materials containing water
• Copper
• Monel
• Brass
• Polyurethane (PUR)

1.7 – Washing, cleaning and packaging

This paragraph describes how to prepare items to be sterilized by CISA SPS. All items
inserted into CISA SPS must be previously cleaned, rinsed and dried. As is the case
for other sterilization processes, sterilization by CISA SPS may be ensured only if the
items have been rightly cleaned and dried.
Cleaning and sterilizing are two different processes. A thorough cleaning is key to
ensure sterilization through all the sterilization methods, including the CISA SPS
sterilization method.
The cleaning process is necessary to remove all organic and inorganic residuals from
the equipment and through this process many microorganisms are removed from the
surface of the device. The sterilization process will eliminate all the remaining living
microorganisms.
Cleaning and rinsing

Remove all blood traces, tissue and other substances from the items using hot water and
an enzyme detergent strictly following the instructions of the manufacturer of the medical
devices according to EN ISO 17664 requirements. To guarantee an effective sterilisation
process it is necessary to carry out the cleaning, rinsing and drying processes according to
validated methods.
For further information see technical appendix.
Drying
Dry all the items well. It is necessary to remove the humidity from all the parts of the
item. Only dry items are to be loaded into the sterilization chamber.
Dry all the items before loading them into the sterilization chamber.
Loads containing humidity in excess may stop the cycle.
Packaging
• Inside the sterilization chamber it is advisable to use only wire baskets

designed by CISA to guarantee the proper spread of gas and plasma.
• DO NOT use cotton cloth on the bottom of the baskets, if need be use
polypropylene sheets.
• DO NOT use sponges inside the baskets as they absorb the sterilizing agent
• Remove from the baskets all items made of materials containing cellulose,
such as: paper, paperboard, cotton, linen, towels, gauze sponges or any item
containing wood pulp.
Please read the instructions for each medical device as far as any special preparation
or disassembly to be carried out before sterilization is concerned.
Use only pouches made of Tyvek® or Tyvek® Assuron and OPA15 film + PE 65 peel,
which have been properly validated for CISA SPS sterilization using validated welding
parameters for these pouches (ex: 123°C for 1,5 seconds at 5Kg/ cm2). Do not use
paper pouches for packaging containing wood pulp or cotton.
Sterility of the packaged product in the pouches described above is ensured for at least
twelve months when the product is properly preserved.
Lumen
CISA SPS sterilizer can sterilize items having lumen within the limits specified
herebelow:
Tube in teflon whose diameter is inclusive between 2 and 20 mm and having a

maximum length of 1,5 mt with a blind end, for a maximum number of three for
each basket.
Do not process inside the CISA SPS sterilizer any medical devices labeled as
“disposable” by the manufacturer of the medical device. Medical devices labeled as
“disposable” by the manufacturer of the medical device are designed for one use only
and are to be thrown away after use following the instructions given by the
manufacturer of the medical device and the rules set out by Your Center.
Medical devices allowed for the SPS sterilization cycle

The following groups of medical devices are allowed for the SPS sterilization process since
they have been validated in the design process of the equipment.
Please keep in mind that this list is not complete.
Electro-scalpel for electro-surgery with cable 2,5 mt length

Bone saws 20 cm length, 15
Perforator
Smarch band 1,5m length
Ambu Balloon 30cm length, 25 cm diameter,
Respiratory mask 15cm x 15cm
Guedel cannulae 12cm comp. and inner diam 3cm
Silicon trachea tubings 22 diam. and 1,20 meter
Facial mask for mechanical ventilation
PVC trachea tubings 22mm diam e 1,20cm length
Surgical instruments 15cm length, 5 mm diameter
Razor blades
Trocar for laparoscopy (15 cm length, 18 mm diam.)
Disposable Clip (50cm length, in PVC)
Scissors 50 cm length, 5 mm diam. in inox and PVC
Forceps for videolaparoscopy
Optics 40 a 50 cm length, 8mm diam.
Electrical cables for optical fibers, 2 mt length, 2,5 and 7,0 mm diam.
Vessels replacement devices
Fouchet probes 1-8 mm diam.
Nelaton robes 35 cm lenght
Endotracheal Cannulae PVC 30cm lenght 12mm diam.
Drainage tubings (suction) 1,5m length 3 mm diam.
Latex products, 2 m length
Catheter 1,5 meter length, 4 mm diam.
Folley probes and catheters, PVS or silicone 35 cm length
Handle for instruments, in PVC or silicon
Surgical instruments in titanium, 30 cm length

Medical devices NOT allowed for the SPS sterilization cycle

Endoscopes
Devices with insulations
Ophthalmologic devices
Implants
1.8 – Load and unloading of the chamber

This paragraph describes the proper use of the CISA SPS sterilizing chamber.
Loading of the chamber

The sterilizing chamber must be loaded so that the gas may circulate freely and
penetrate inside each package. The load of the autoclave must be evenly distributed
and must not touch the inner parts. All the items to sterilize must be exposed so that
each surface is directly exposed to the sterilizing agent for the scheduled temperature
and length of time .
Place the pouches into the appropriate net baskets so that they are parallel to the flow
of the gas, do not press them. The surfaces in Tyvek ® of the pouches must be
matched together. The tools must be disassembled and their surface to sterilize free,
the content of the baskets must not be pressed. The tubes must not be closed at their
sides nor folded. Rubber gloves must be placed stretched and not folded. Once loaded
the autoclave can be started to carry out the cycle by choosing this latter through the
touch screen.
Pay attention to the following instructions:

• The total mass of the metallic material must not exceed 3 kg for each basket
• The total mass of the plastic material must not exceed 1 kg for each basket
• In case of mixed loads the metallic and plastic materials must be evenly distributed
inside the total volume of the chamber
• The load must not exceed the limits of the basket
OK NON OK
• Place the objects inside the baskets so that the gas may touch on them. Do not
stack the possibile bowls inside the baskets.
• If possible, place the pouches on the fore end
• Prevent the metallic items from touching the walls of the sterilizing chamber
Monitoring the cycle

It is very important to confirm that the sterilizing conditions are present during a cycle
inside the sterilizing chamber. It is necessary to test these conditions by introducing at
every cycle a biological indicator model ProTest H2O2 contained in the challenge device
(CISA SPS Cycle Monitoring PCD) and placed in the lower grid next to one of the corners
as shown by the scheme:
Loading side
Unloading of the chamber

At the end of the cycle that has run regularly, the door can be opened from the control
side to unload the material or from the sterile side in case of two-door execution.
Before unloading the material make sure there is no humidity on it due to the
condensation of the sterilizing agent. In this case it is necessary to wear latex or vinyl
gloves and remove the condensed agent by means of a humid cloth. Make sure the
pouches of medical devices are undamaged and check the proper colour change of
the external process indicators.
The biological indicator inserted into the challenge device (PCD) will have to be
retrieved and placed in incubation following the instructions. The material must be
warehoused in a proper place and released when the tests give their results prior
check of the printing parameters.
WARNING!
If at the end of a normal or irregular cycle the objects inside the
load look humid there may be some oxidizing agent in liquid form.
Wear gloves when removing the objects from the chamber and rub
them with a humid cloth.
1.9 - Release criteria

Before releasing the material at the end of the sterilizing process the following
conditions must be respected:
- The chemical indicator on the packaging pouches must have changed its colour
properly. Please follow the specifications of the manufacturer of the packaging.
- When printing the completed cycle the legend “cycle executed regularly” must
appear

- The incubation of the biological indicator must give a negative result (no growth).
Please follow the specifications of the manufacturer of the biological indicator
1.10 - Cartridges
For each sterilizing cycle it is necessary to insert a cartridge containing the chemical
solution which will produce the sterilizing agent.
Warehousing
The warehousing of cartridges must take place in a ventilated environment with a
temperature below 30°C in their original packaging until the moment of use.
When the cycle starts the used-up cartridge will have to be removed and the new one
inserted. It is possible to remove/insert the cartridge by using the proper menu in the
Touch screen “Loading of the cartridge” to be found in the main menu.
Wait until the door opens and the used-up cartridge comes out
(fig.1 point 4). Remove the old cartridge and insert the new one
until it clicks. Confirm this operation through the Touch screen.
The cartridges have a six-month validity starting from the

production date and their expiry is checked through scanning. If a
cartridge has expired or has already been used, the operator will
have to insert a new cartridge.
Disposal
The used up cartridges may be disposed of as a hospital waste.
Unused and unbroken cartridges will have to given back to CISA or disposed of directly by
the responsible operators strictly following the disposal procedures set out by CISA upon
request.
WARNING!
Do not try to open or tamper with the CISA SPS cartridges not
even after use. Dispose of cartridges following the procedures set
out by hospitals when disposing of hospital wastes.
WARNING!
The cartridges in CISA SPS contain concentrated hydrogen
peroxide, which is a powerful oxidizing agent. Concentrated
hydrogen peroxide is harmful for your skin, eyes, nose, throat,
lungs and gastrointestinal tract. Direct contact with your skin can
cause serious chafing. In case of contact rinse immediately with
abundant water. If symptoms are serious or persist see a doctor
immediately. Direct contact with your eyes can damage tissues
irreversibly In case of contact with your eyes rinse immediately
with abundant water and see an ophthalmologist right away. The

inhaling of vapours can seriously irritate lungs, throat and nose. If
you inhale vapours go outdoors, breathe fresh air and see a
doctor right away. Ingestion can be very dangerous. In this case
drink immediately lots of water to dilute. Do not provoke vomit.
See a doctor.
1.11 - In case of invalid cycle
It is possible that a fault or a malfunction of the sterilizer or a manual intervention may stop
a sterilizing cycle . In this case the sterilizer carries out a procedure to stop the cycle to let
the door open and retrieve the material. Pay attention when the door opens as described
in the paragraph “Loading and unloadjng of the chamber”. The material will have to be
packaged again before insertion into the sterilizer.

1.12 – Sterilization cycles

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.
Cycle °C Min / n. cycles Devices
30 20 x 2 No narrow nor long holes
30 20 x 2 Narrow and long holes
Request by the customer

30 Request by the cusomer
(20 x 2)
While the cycle is running it is possible to check the parameters and the stages on the
touch screen and on the printer.

STERILIZATION CYCLE – P1 – t’=20 x 2
1000
1000
sterilization
100
100
washing
1010
1 1
-1
1x10
1x10-1
-2
1x10
1x10-2
-3
1x10
1x10-3
-4
1x10
1x10-4
00 90
120

STERILIZATION CYCLE – P2 – t’=20 x 2
1000
100
10
1x10-1
1x10-2
1x10-3
1x10-4
0 120

STERILIZATION CYCLE – P3 – t’= variable (requested from the customer)
1000
100
10
1x10-1
1x10-2
1x10-3
1x10-4
0 120

1.13 - Safety systems

The autoclave is equipped of the following safety devices that make it extremely reliable:
Device against the starting of the cycle if the door is open or if it’s not perfectly closed..
Limit switch of right positioning of the door(s) of load.
Device that prevent the simultaneously opening of the doors (two doors model)
Limit switch of right positioning of the doors(s) of load.
Device that in presence of obstruction along the path, stops the closure of the door, inverting the
direction until the maximum opening position.
Verify of the maximum time used for the closure of the pneumatically door.
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)
Safeties accident protections

Micro switches 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.

1.14 - Set-point safety systems and functionality

In the following diagram you have illustrated the components referring to the
security, the functionality and their settings.
Security
Component Set-point
Compressed Air Safety Valve SSP
and pressure regulator FRAC 1,9 Bar
Look at Pneumatic scheme in nnexes
Functionality
Component Set-point
Pressure regulator FRM
Look at Pneumatic scheme in 6,0 Bar
annexes

1.15 - Operator codes

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
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.

LEVEL START START CHANGE CHANGE CHANGE MAINTE PARAM PARAM RESET MANUAL CALIBRA
OF THE OPEN OPEN STANDARD DATE NANCE ETERS ETERS ALARM ADVANCING TION
CYCLES
(1)
CYCLE CYCLES CYCLES AND 1 2
I TIME
Autoclaves CISA
*
2
* Function activated.
*
3
* *
4
* * * *
5
* * * * *
Function activated with an additional code CISA.

6
* * *
7
* * * *
8
* * * * * * * * *
9
* * * *(1) * * * * * * *
Pag.33
1.16 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
resettled, the following list indicates the type of alarm:
TYPE OF ALARM LEVEL1 LEVEL 2 TECHNICAL

INTERVENTION
STOPPED CYCLE
THERMAL VACUMM PUMP
LACK OF WATER (1)
THERMAL PLASMA
THERMAL HIGH VACUUM PUMP
FAILURE VACUUM PUMP
MAXIMUM TIME OF STAGE (1)
FAILURE HIGH VACUUM
TRANSDUCER
FAILURE PROBE COOLER
DIELECTRIC TEST FAILED
FAILURE PLASMA
DOOR OPEN (1)
PROBLEM WITH STAGES
PLC BATTERY EXHAUSTED
TRANSMISSION ERROR (1)
FAILURE HEATER
PRESSURE OUT OF RANGE (1)
DOSING SYSTEM ERROR (1)
FAILURE INJECTION VALVE (1)
EMRGENCY BUTTON
FAILURE PROBE CHAMBER n.1
WRONG POSITION OF NEEDLES (1)
FAILED POWER SUPPLY
WRONG SEQUENCE
FAILURE LOW VACUUM
TRANSDUCER
(1) Only in case of repeated alarms

Level 1, alarms that do not end cycle
Level 2, alarms that end cycle

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 the thermic of the vaccum pump with liquid ring starts. This
happens when there are problems on the motors of the vacuum pump or on the water
network or on the power supply.
Shortage of water
This alarm intervenes when a max. time for the load of water in the generator has been
reached in water recovery tank (10 minutes).
Thermal plasma
This alarm goes off when the thermal of the plasma generator starts . This happens when
there are problems in the matching transformer or on the electric network.
Thermal high vacuum pump
This alarm goes off when the thermal of the high vacuum pump starts. This happens when
there are problems on the engine or on the electric network.
Failure vacuum pump
This alarm goes off when the vacuum pump with liquid ring does not reach 500 mBar
pressure in the first two minutes of the cycle. This happens when there are problems on the
engine or on the electric network or on the water network.
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 of high vacuum.
Failure probe evaporator
This alarm goes off when an anomaly in the temperature of the evaporator is signaled.
Failure dielectric test
This alarm goes off when the dielectric test at the beginning of the sterilization cycle has a
negative result. This happens when there is a short circuit between the outer grid and the
chamber.
Failure plasma
This alarm goes off when there is an anomaly during plasma generation.
Door open
This alarm intervenes when during a cycle the door limit switch does not signal the right
closure.
Problem at the stages
This alarm goes off when there is an anomaly in the feeding stages of the sterilizer (missing
stage or reversal).
PLC battery exhausted
This alarm goes off when the battery of one or both PLCs must be replaced.
Error Transmission
This alarm intervenes when it is any anomaly of dialogue between the process PLC and the
security PLC.
Failure heater
This alarm goes off when the temperature of the evaporator is not reached within the
scheduled time.

Out of range pressure

This alarm goes off when the pressure in the stage of gas diffusion (sterilization) is out of the
set limits.
Dosing system error
This alarm goes off when there is a failure in the dosage system.
- Maximum time of load dosage tank
- Minimal time of load dosage tank
- Maximum time of unload dosage tank
- Incorrect placement of the cartridge
Failure injection valve
This alarm goes off when the pressure before gas inlet is too high.
Emergency push-button
This alarm is shown after the restoration of the emergency push-button.
Failure probe chamber n.1
This alarm goes off when there is an anomaly in the signal of the chamber temperature
– probe n.1
This alarm goes off when there is an anomaly in the signal of chamber temperature – probe
n.2
This alarm goes off when there is an anomaly in the signal of chamber temperature – probe
n.3
Wrong position of needles
This alarm goes off when there is an anomaly in the position of dosage needles.
Shortage of power supply
This alarm intervenes when there is a shortage of power supply.
(Caution! This alarm intervenes also in case of turning off of the machine through specially
button on the test board.
Wrong sequence
This alarm goes off when there is an anomaly in rotation of running stages.
Failure low vacuum transducer
This alarm goes off when there is an anomaly in the signal of the transducer of low vacuum
pressure.
Like see in the table for each type of alarm exists a level:
- LEVEL 1
it’s an alarm that is only visualized and it doesn’t modify the sequence of the cycle
- LEVEL 2
it’s an alarm that ends the cycle after have execute a procedure of atmospheric restore in
the chamber composed of three vacuums extended and a minute of aeration.
In the case of non-power supply in any phase of the cycle, at return of the voltage the
machine is in stand-by. Only al the moment of reset it will start the procedure descript for an
alarm of level 2. (par.2.18)

2.0 MANAGEMENT OF THE AUTOCLAVE

The following instructions on management are based on the following software versions:
Touch-Screen : Version 10
PLC (Programmed logic control device) : Version 33
It is possible to verify the version in the initial page at the time of ignition.
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.
Skilled technical staff must execute the maintenance and repairing of

the sterilizer.
-Ensure that the cocks WATER ARRIVAL (hydraulic diagram in the annexes)
and AIR ARRIVAL (hydraulic diagram in the annexes) placed inside of the
sterilizer are open.
-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 emergency push-button (n.4 pictures 2 and 2) is not activated.
Switch on the autoclave acting on the ON-OFF push-button (n.2 picture 2)
The display will show :

where
reports the model of the autoclave
reports the total number of the executed cycles
At the right-end side herebelow it is possible to verify the software version. The two digits
before the dot indicate the software revision of the display, the remaining ones of the PLC.
(Ex: Rel 10.0032 indicate version 10 for the display and 32 that of the PLC)
Open the door acting on the push-button (Main Menu 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 (Main Menu par.
2.3) and 7 (picture 2)
Push any point of the display to continue.
2.3 - MAIN MENU


Where:
Silence the buzzer of an alarm or of end of cycle signalling.
From the main menu is possible to reach to the different functions of the machine:
START CYCLE : relatives to the management of the cycles (par. 2.4 a par. 2.10)
VALUES : relatives to the state of functionality of the machine (par.2.11)
MAINTENANCE : relatives to the programmed maintenance of the unit (par 4.0)
TECHNICAL FUNCTIONS : relatives to the management of the technical parameters (par
3.0)
CARTRIDGE LOAD: relative to the cartridge load
This icon shows the presence of an alarm. To cancel alarms in course see the
paragraph 2.18
2.4 - PROCEDURES FOR THE STARTING OF A CYCLE
The starting of the cycle happens with a selection following of some settings briefly summing
up in following:
- Cartridge insert
- Selection of the type of the cycle
- Insertion of the operator code (if requested or qualified)
- Insertion of the lot code (if qualified)
- Insertion of the number of the labels to print (if optional qualified)
- Confirmation of the data
The first operation so will be:

Push from the main menu:
Push “START”, to remove the old used cartridge and put the new one. At the end of the cycle
the display shows:
With the referee:
If during the cycle it shows:
- Error reading
It depends from the wrong reading of the code of the cartridge. Start again the loading:
- Cartridge already used

or
- Cartridge expired
To substitute with a new one.

At the end of the loading procedure, start again from the main menu and push “EXIT”.
Push “Start cycle” from the main menu
The display will show the available cycles relatives to the model of the sterilizer :
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.1.4)
The cycles foreseen from the unit are the following:
- CYCLE P1
Exposure Time 20’. This cycle permit to sterilize material with free surfaces.
- CICLY P2 .
EXPOSURE TIME 20’ x 2 . This cycle permit to sterilize materials with cable parts.
- CYCLE P3 .
EXPOSURE TIME VARIABLE. THIS CYCLE CAN BE REQUESTED FROM THE CUSTOMER.
Push to exit and come back to the main menu
Push to start the cycle
2.5 - 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:
Select to insert the lot code;

At this point will be visualized the alpha-numeric keyboard described in the par.3.1.1.
If it will be confirmed the inserted data, wait a few seconds while the display will show:
2.6 - INSERTION OPERATOR CODE

This function can be qualified or disqualified according to internal procedure of the system of
management of the sterilized.
Digit the operator code.
Digit to confirm
Digit to delete the inserted numbers.
2.7 - CONFIRMATION START OF THE CYCLE
Before to give the start at the cycle is necessary to confirm the inserted data.

or, it will show:
Push to cancel the procedure and come back to the page relative at the selection of
the cycle
Push to confirm.
This message:
attract attention of the operator remember that one of the components of the machine had
reach the number of hours fixed of work. Such message doesn’t jeopardize, in any case, the
execution of the cycle. To visualize which is the component interested, to enter from main
menu in the “maintenance” section and eventually ask the intervention from skilled staff in
control to the maintenance.

2.8 – PRINT OF LABELS
This function has not been implemented into the current software
as yet.
If the autoclave is equipped with an external label printer will be shows the sequent page:
Digit the number of labels to print automatically at the end of the cycle and push .
Labels will not be automatically printed if we insert the value “00” or if the cycle not ends
rightly. (reprint labels process par. 2.22)
2.9 - 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.

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) - Cartridge
Check if the cartridge is inserted.
3) - Printer Ready
It checks that there are not problems with the built-in printer.
4) – Alarms
It checks the presence of alarms in background. After start the cycle it is
necessary reset the eventually alarms in course.
5) – External consent
Possible outside consents for the sterilizer (Ex: emergency buttons, etc.)
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.
2.10 - 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 following parameters are visualized in real time:

- Pressures and temperatures an chamber
- Solution temperature
- chamber temperature
- the remaining time to the end of the cycle calculated on the arithmetic mean
of the last ten cycles of the same type executed regularly.
The push-button is relative to the function of manual advancing (par. 2.12) while
push-button serves to cancel the cycle in course (par. 2.13).
Push to enter in a under menu of selection (par. 2.14).

2.11 - 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).
2.12 - CANCELLATION OF THE CYCLE

As from the paragraph 2.11 pushing is possible to cancel the cycle in

course.
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.
2.13- UNDERMENU OF SELECTION
As from paragraph 2.11 push to enter to a under menu:

Where:

Permits to check the value of the phase set in course with the
programmed set value (par. 2.15).
Permits to show the alarms in course (par. 2.18).
Permits to show the alarms store happened (par.2.18.1).
Permits to show the values of the process of the

autoclave. (par. 2.16).
Permits to show in real time the course of the temperature and

of the pressure (par. 2.17).
Permits to show the state of the automatic load and unload

device.

2.14- SET-POINT PAGE
Digit to compare the set value of the phase in course

with the value of the programmed value.
They are visualized:

-temperature chamber in °C;
-pressure chamber in mBar;
-time phase in second;
-number of pulsations of vacuum/pressure;
-hour;
-date.
The warning light switch on shows the parameter in comparison, according to the
phases.
During the B&D cycle, in the sterilization phase, the phase time will be expressed
in seconds.
Push to come back to the visualization of the page menu. (par. 2.14)

2.15 - SINOPTIC
Push to visualize the process values in the

chamber and in the jacket.

-temperature jacket in °C;
-temperature solution;
-pressures chamber in mBar;
-presence of the solution.
Push to come back to the visualization of the page menu (par. 2.14).
Push to enter in the function of calibration. (par. 3.12)
Pressing the button on the cartridge indication on the upper left-end side the dosage device
is visualized in detail:

The “RESET” button must be used in case there is a system jam.
Press to visualize the synoptic again.
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.


• Temperatures chamber;
• Chamber temperatures in °C (orange, brown and purple)
• Chamber pressure (blue) in millibar relating to scale field on the left , 10-3-10-3
• Chamber pressure (green) in millibar relating to scale field on the right, 0-100
Digit to visualize the full course of the cycle.
Digit to print the last reprinting of the last cycle memorized.
Digit to return to the visualization of the page menu (par. 2.14).
2.18 - ALARMS PAGE
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.
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 cycle at the end this page will be
visualized again for to remember at the operators that an alarm is intervened,
push to come back to the main menu.
2.18.1 - ALARMS HISTORY PAGE
The page shows all the alarms elapsed in the time. The list reports the date and the hour of
the alarm (small red square) and the date and the hour of his deletion (small blue square).
push to come back to the menu.
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

In the case of double door sterilizer 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).
This page will be visualized until the unload door will be opened.
Open the sterile door with the push-button n.11 at picture 8, to extract the material and close
the door with the push-buttons n.7 at picture
If anyway we desire to open the load side door, pushing and to maintain pushed any zone of
the display for least 5 seconds.
It will be visualized:
Pushing we come back to the main menu and we will open the load side door.
Once open the load side door, we will not more open the sterile door if not at the end of the
next cycle.
Pushing we will come back to the previous situation.

At the open of sterile side door the display will show:
it will can work only after that the door will be closed.
The doors in the passing autoclaves are interblocked, that is not possible open a door if the
other is opened. The unload side door will be open only after a sterilization cycle executed
rightly, and it will can open and close until the load side door will open.
In the case that the sterilizer is at single door the display will show:
Push on the display to come back to the main menu (par. 2.3).
At this point it is possible to open the door keeping pushed the button
(Main menu Par. 2.3) and n.11 at picture 8 until full open, and to extract the material.

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:
CISA SpA
laboratory CISA Heading (par.3.9)
---==oOo==---
Autoclave Mod.CISA 6464 Autoclave model
Start of cycle Date and time of start of the cycle
10:44:41
01/01/07 Serial Number
SN00000-00-00-00-0000000 Operator name
Operator:
Supervisor Lot code (if activated, par.3.9)
Code of lot:
1234567890
Selected cycle with the indication of the temperature and
Cycle 2 sterilization time.
STERILIZATION 1200 sec
Indication of the time, temperature, pressure of the phase in

10:44 22.2°C 1258.94 mB course.
DIELECTRIC TEST
Indication of the hour, temperature chamber and pressure
10:45 22.2°C 1258.94 mB
chamber at the moment of the change of the sub phase and
HEATING
indication of the sub-phase with the relative set.
11:12 29.5°C 0000.08 mB
GAS INLET
Indication of time, temperature and pressure in the
11:13 29.4°C 0000.12 mB
STERILIZATION 1200 sec sterilization stage at the preset frequency (30 sec.)
Time Cham. Tem. Cham.
Press.
11:13 29.3°C 0008.40 mB
11:14 29.3°C 0013.60 mB
11:14 29.4°C 0017.40 mB
11:15 29.4°C 0020.30 mB
11:15 29.5°C 0022.40 mB
11:16 29.6°C 0023.90 mB
11:16 29.6°C 0024.60 mB
11:17 29.7°C 0024.90 mB
11:17 29.7°C 0025.00 mB
11:18 29.8°C 0025.10 mB
11:18 29.8°C 0025.30 mB
11:19 29.9°C 0025.30 mB
11:19 29.9°C 0025.40 mB
11:20 29.9°C 0025.50 mB
11:20 29.9°C 0025.50 mB
11:21 30.0°C 0025.50 mB
11:21 30.0°C 0025.50 mB
11:22 30.0°C 0025.50 mB
11:22 30.0°C 0025.60 mB
11:23 30.0°C 0025.60 mB
11:23 30.0°C 0025.60 mB
11:24 30.0°C 0025.60 mB

11:24 30.0°C 0025.60 mB

11:25 29.9°C 0025.60 mB
11:25 30.0°C 0025.60 mB
11:26 29.9°C 0025.60 mB
11:26 29.9°C 0025.60 mB
11:27 29.9°C 0025.70 mB
11:27 29.9°C 0025.70 mB
11:28 29.9°C 0025.70 mB
11:28 29.9°C 0025.70 mB
11:29 29.9°C 0025.70 mB
11:29 29.9°C 0025.70 mB
11:30 29.8°C 0025.70 mB
11:30 29.8°C 0025.70 mB
11:31 29.8°C 0025.70 mB
11:31 29.8°C 0025.70 mB
11:32 29.8°C 0025.70 mB
11:32 29.7°C 0025.70 mB Indication of time, temperature, pressure of the current stage
11:33 29.7°C 0023.44 mB
WASHING
11:43 27.9°C 1258.94 mB

HEATING
12:06 30.0°C 0000.08 mB

GAS INLET
Cycle with two exposures.
Indication of time, temperature and pressure in the
12:13 29.4°C 0000.12 mB
sterilization stage with the preset frequency (30 sec.)
STERILIZATION 1200 SEC
Ora T.Cam. P.Cam.
12:07 30.2°C 0008.70 mB
12:08 30.3°C 0014.00 mB
12:08 30.4°C 0017.90 mB
12:09 30.5°C 0020.90 mB
12:09 30.6°C 0023.20 mB
12:10 30.6°C 0024.70 mB
12:10 30.8°C 0025.50 mB
12:11 30.9°C 0025.80 mB
12:11 30.9°C 0026.00 mB
12:12 31.0°C 0026.10 mB
12:12 31.0°C 0026.20 mB
12:13 31.0°C 0026.30 mB
12:13 31.1°C 0026.40 mB
12:14 31.1°C 0026.40 mB
12:14 31.1°C 0026.40 mB
12:15 31.1°C 0026.50 mB
12:15 31.1°C 0026.50 mB
12:16 31.0°C 0026.50 mB
12:16 31.1°C 0026.50 mB
12:17 31.0°C 0026.50 mB
12:17 31.0°C 0026.50 mB
12:18 31.1°C 0026.50 mB
12:18 31.1°C 0026.50 mB
12:19 31.1°C 0026.50 mB
12:19 31.2°C 0026.50 mB
12:20 31.2°C 0026.50 mB
12:20 31.3°C 0026.50 mB
12:21 31.3°C 0026.50 mB
12:21 31.3°C 0026.50 mB
12:22 31.3°C 0026.50 mB

12:22 31.3°C 0026.50 mB
12:23 31.4°C 0026.50 mB
12:23 31.4°C 0026.50 mB
12:24 31.4°C 0026.50 mB
12:24 31.4°C 0026.50 mB
12:25 31.4°C 0026.50 mB
12:25 31.4°C 0026.50 mB
12:26 31.4°C 0026.50 mB
12:26 31.4°C 0026.50 mB Indication of time, temperature and pressure of the current
stage
12:27 31.4°C 0034.67 mB
WASHING
12:37 29.4°C 1288.26 mB

COMBINATION
12:37 37.1°C 0000.11 mB Total time of the cycle

AERATION Progressive number
Total time 0135 min. Indication of cycle regularly carried out
Progressive N.0000000012
13:00 37.6°C 1258.94 mB
CYCLE ENDED
REGULARLY

Following an example of print of an anomalous cycle:
CISA Srl
Laboratory CISA Personalization string
---==oOo==---
Autoclave Mod.CISA 6464 Autoclave model
Start of cycle Date and time of start of cycle
10:44:41
01/01/07 Serial Number
SN00000-00-00-00-0000000 Operator’s name
Operator:
Supervisor: Code of lot (if enabled, par. 3.9)
Code of lot:
1234567890
Cycle selected with indication of time of sterilization
Cycle 2
STERILIZATION 1200 sec
Indication of time, temperature and pressure of the current
stage.
10:44 22.2°C 1258.94 mB
DIELECTRIC TEST
10:45 22.2°C 1258.94 mB

HEATING
11:12 29.5°C 0000.08 mB

GAS INLET
Indication of time, temperature and pressure in sterilization
11:13 29.4°C 0000.12 mB
STERILIZATION 1200 sec stage at the preset frequency (30 sec.)
Time Cham. T. Cha. Pr.
11:13 29.3°C 0005.40 mB
11:14 29.3°C 0007.60 mB
11:14 29.4°C 0009.70 mB
11:15 29.4°C 0010.30 mB
11:15 29.5°C 0012.40 mB
11:16 29.6°C 0013.90 mB
11:16 29.6°C 0014.60 mB
11:17 29.7°C 0014.90 mB
11:17 29.7°C 0015.00 mB
11:18 29.8°C 0015.10 mB
Indication of an alarm ringing
11:18 29.8°C 0015.11 mB
ALARM Description of alarm
MINIMAL PRESSURE
12:30 37.1°C 0000.11 mB

AERATION Total time of cycle
Total time 0052 min. Progressive number
Progressive N.0000000012
13:00 37.6°C 1258.94 mB Indication of cycle that has run irregularly.
CYCLE ENDED
IRREGULARLY

2.20 - LOADING/UNLOADING OPERATIONS

The loading/unloading of the materials have to be realized handly with baskets.
2.21 - LABEL REPRINTING
This function has not been implemented into the current software
as yet.
If the autoclave is equipped with a label printer is possible reprint any number of label of the
last cycle ended valid in case we want, to select from the main menu.
To select
Digit the number of labels chosen
Confirm with
To begin the printing push
To exit push

3.0 TECHNICAL FUNCTIONS

All the informations of this chapter are related to the Operator Interface (Touch Screen) and
explain all the capabilities of the CISA SPS management software.
3.1 - DATA INSERTION

Every time that will be necessary introduce information in the management system, will come
visualized two different typologies of keyboards. Insert codes composed from figures and
characters (ex. code of the lot) will be visualized an alphanumeric keyboard, for the
numerical data instead a numerical keyboard to 10 figures. Following are described the
different functionality.
3.1.1 - Numerical data insertion

For to change an alphanumeric value, if the keyboard is not visualized, to press the data that
it is wanted to change and will appear the following keyboard:
Press capital letters for the utilization.
Press enter to other symbols.
Press to use the capital letters.
Press to use other symbols.
Press to cancel all the line.
Press to cancel the characters one per time.
Press to create space between the characters.
Use the to run inside the line.
Press or to exit from the keyboard.
Press to confirm.
In the case of the modification of a data already existing, use the arrows and the key BS for
the cancellation of some characters, otherwise to press CLR and to introduce the value.
3.1.2 - Insert the numerical data.

For to change a numerical value, if the keyboard is not visualized, to press the data that it is
wanted to change and will appear the following keyboard:
Press to cancel the characters one per time.
Press to cancel all the line.
Press or to go out from the keyboard.
Press to confirm.

3.2 - PROCEDURE FOR THE MANAGEMENT OF THE TECHNICAL PARAMETERS
Push from the main menu (par. 2.3)
Insert its own operator code and press OK.

According the correspondent level to the interrupted code a menu of selection to the
functions relatives at that level will be visualized.

3.3 - ACCESS TO MENU
Inserted the operator code will be visualized the following menu:
Where:
Consents to enter in another menu(par. 3.3)
Consents to change the parameters of the standard

cycles(3.7)
makes it possible to change the printing parameters .

(par. 3.9)
Consents to change the relative parameters at the
management of the autoclave (par. 3.10)
makes it possible to change the parameters of standard cycles

(par. 3.7)
Consents to enable/disabile the selectable cycle (par. 3.11)
makes it possible to change some additional parameters of

the autoclave
Timer Function and Stand-by (par. 3.15)
In the above-stated menu is also possible select the chosen language.
Digit to exit.
Digit on the relative flag for the selection of the touch screen language.

Selecting the display will show:
Where:
Consents to change the current date and time (par. 3.4)
Consents to change the parameters relatives at the

maintenance (par. 3.8)
Manual activation of the exits (par. 3 13)
Manual activation of the exits in the synoptic
Digit to exit.

3.4 - CHANGE DATE AND HOUR
Select
the display will show:
Select the fields to modify and digit the chosen number with the numeric keyboard.
Digit at every modify for confirmation.
Digit to delete.
Digit to memorize the change.
Digit to exit.

3.5 - MODIFICATION OF THE PARAMETERS IN THE OPEN CYCLES
This function has not been implemented into the current sofware
as yet.
Digit from the selection menu (par.3.3).
Digit to continue.

Select .
Digit the number relative at the cycle that it is wanted to modify by the numeric keyboard.
Digit to confirm.
Digit to delete.
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.
insertion values
confirm values
reset the settled value Inserts the decimal values
it executes or not the phase according which of the two is green flashing.

As soon as an open cycle or standard cycle to modify is selected the parameters relative to
the phases that make the cycle will be visualized. The phases are:
• HEATING
• GAS INTRODUCTION
• STERILIZATION
• WASHING
• COMBOPLASMA
• PULSATIONS
The display visualizes:
It can validate and invalidate the phase.
PHASE 1 - HEATING

These parameters are changeable:
Initial plasma :
Time: minimal of plasma (sec)
Temperature: Temperature set of the load (°C)
Pressure: High vacuum set (mechanical pump) to start plasma stage (mBar)
Vacuum time: Vacuum time(liquid pump ring) (sec)
Vacuum high set: High vacuum set pre-ignition of gas (mBar)
Interstage plasma time:
Time: Minimal time of plasma in between stages (sec)
PHASE 2 – GAS INTRODUCTION
Injection time: Gas injection time (sec)
The injection time must always be the same as the activation time of the vacuum
mechanical pump.
PHASE 3 – STERILIZATION

Time: sterilization time (sec)

Number of repetitions: Number of exposures to gas (max. 2)
PHASE 4 - WASHING (vacuum - air)
Vacuum time vacuum time (sec)

Aeration time aeration time (sec)
Puls. number: pulsation number vacuum - air

PHASE 5 – COMBOPLASMA
Plasma time:
Time: Tempo plasma al raggiungimento del set (sec)
Temperature: Heating temperature of load (°C)
Vacuum time: Vacuum time(liquid pump ring) (sec)

Vacuum high set: High vacuum set (mechanic pump) (kPa)
STAGE 6 - PULSATIONS
The display will visualize:
The following parameters are changeable:

High vacuum set:

Pressure: Pressure set to reach (mBar)
Time: Stay time of set (sec)
Aeration set:
Pressure: Pressure set to reach (mBar)
Time: Stay time of set (sec)
Number of Pulsations Number of pulsation air-high vacuum
Digit to confirm the data inserted.
Digit to come back to the phase of the cycle to modify.
Digit to exit.
If the inserted data will confirm the display will show:.

await a few seconds and the display will come back to the selection menu (par.3.3).
3.7 - MODIFICATION OF PARAMETERS RELATIVE TO THE MAINTENANCE
Digit from the selection menu (par.3.3)
This function consents to enter and modify parameters relative to the

maintenance of the components to take care.
Where:
“WITHIN” reports the N° of lacking hours at the execution of the maintenance of the
correspondent component.
“SET” reports the number of hours of prefixed functioning for the correspondent component.
Pressing the field to modify it will have access to the numeric keyboard decrypted in the par.
3.1.2
Digit to exit.

3.8 - MENU PARAMETER OF PRINT
Pushing is disabled the printer.
It indicates the interval of time expressed in seconds to have the

print of temperatures and pressure, in the sterilization phase.
To set the choose value select the field and use the numeric keyboard.
Digit to exit.
3.9 - MENU’ GENERAL PARAMETER

To change the relatives data to an operator select the field

Digit then the operator number that we want to show/modify by the numeric keyboard and
push “ENT” to confirm the choice.
At this point is sufficient select the field to change the operator code and the
field to modify the level.
disable the operator code.
enable the lot code of production after the start of the cycle.
ALL THE OPTIONS ARE ACTIVATED IF THE PUSH-BUTTON IS GREEN.
To modify the heading in the print select .

Selecting it will have access to the alphanumeric keyboard

descript in the par. 3.1.1.
Digit “ENTER” to confirm. The display will show for some seconds the following message:
Subsequently it will come back to the selection menu.
To the modification of the codes and operator levels select .
Pushing the letters on the horizontal bar “INFO”, it will be descript the correspondent function
at every single letters. The table will permit us to enable/disable every single function at the 8
levels simply pushing the correspondent from the crossing of the 2 coordinates (letter - level).
Digit to confirm.
Digit to exit.
To modify the operator number select

Selecting we’ll access to the alphanumeric keyboard descript

in the par. 3.1.1.
Digit “ENTER” to confirm. The display will show for some seconds the following message:
Subsequently it will come back to the selection menu.
Select for start the print operator list.
3.10 - MODIFICATION OF THE STANDARD CYCLES
This message shows that a modify at the standard cycles already validated will be revalidate
after their use.

Digit to continue.
Insert the code for the modification of the open cycles supplied by CISA. For to
obtain this code send by FAX the request specifying the Serial Number that
appears on the print (ES: SN0000-00-00-00-0000000)
Choice the standard cycle that it wants to modify and proceed as specified for the
modification of the parameters. (Par.3.7).

Push to return to menu (par. 3.3)
3.10.1 - STANDARD CYCLE CONFIGURATION
Choose, pushing on the display, the cycle to enable / disable from the “choice cycles” menu.
Push to return to menu (par. 3.3)

3.11 - CALIBRATION
DANGER! Skilled staff must execute the calibration procedure. 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:
B
B2
P
P2
A2 A
A1 P1 B1
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.

B2
B2
P
P2
A
A2
A1 P1 B1
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.
B
B2
P2 P
A2 A
A1 P1 B1
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 of the Pirani transducer (Plc n.1) (Plc n.1) è 10-3 – 103 absolute millibar
calculated with the following formula:
(V-6)
P=10
Where VF is the value in volt of the transducer. The scale field is 0 – 10 volt, thus 1000
hundreth of volt. 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 = 2000
The pressure scale of the capacitive transducer (Plc n.2) is 0 – 100 absolute millibar , expressed in tenth
of millibar 0 – 1000. The values of A1 and B1 are added to a whole number having 1000 as value.
A1 = 1000
B1 = 2000
Hereinafter is reported the procedure for the modification of values A1 and B1.
Autoclaves CISA Page 84

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:
Digit to continue,
Select the component to calibrate among the following:.

- Chamber pressure
- Temperature solution
- Temperature chamber
-
Digit to exit

CALIBRATION OF THE CHAMBER PRESSURE.
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:
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, the
modifications applied on the contrary to the probe 2 will be effective only after to have pushed the push-
button , pushing the push-button without to have confirmed with the push-button
the possible modifications applied to the probe 2 will be lost.
For to determine the values of A1 and B1 it needs to check more points of reference as for example:
- 1000 mBar pressione atmosferica

- 100 mbar A
- 10 mbar A
- 1 mbar A
- 0,1 mbar A
- 0,01 mbar A

CALIBRATION OF THE CHAMBER PRESSURE
The probe of temperature of the solution is situated at the interior of heater. Wait for stabilization and
proceed with calibration:
The display will show the values of ZERO (A1) and SPAN (B1) of the sensor.
Acting on the selectors is possible to change the values verifying the result obtained P1
Pushing the button is possible to return back to calibration menu.

3.12 - MANUAL ACTIVATION OF THE OUTPUTS
DANGER! The forcing procedure of the exits must be executed

with the maximum caution and from skilled staff. An illegitimate
use of this function can cause damage both at the sterilization
process and at the staff.
This function must be used at the only aim of maintenance and

only from skilled staff.
NOTE: Is not possible to reach to this function during the execution of a cycle!
The forcing procedure of the exits act directly on the internal functions of the PLC, it making in able to act
manually the bit of exit passage the touch screen user interface.
Digit the display will show:
All the exits will be setted at their default value (OFF)
Digit to enter in the main page:

It is possible act every single bit of the channels 100 , 101 and 102; every bit has a function inside the
machine system, and it do referring at the electric diagram reported in the attached .
Pushing
The display will show the relative page at the channel 100:
Digit the choice push button and the correspondent exit will be immediately activated.
Digit the push button to come back to the main page.
The state of the bit can be bring back at the original state pushing again on the key,
or pushing to come back to the main page.
Pushing from the main page,

On this page there are reported the exit bit relatives at the channel 101.
Here it is possible to act temporarily the exits in the mode upon reported, too.
Pushing from the main page,
the display will show:
On this page there are reported the exit bit relatives at the channel 102.
Here it is possible to act temporarily the exits in the mode upon reported, too.
The sinoptic permits to activate the specified exits.

The market areas indicate the components that can be activated after selection the “MANUAL”
functionalities. The procedure “ Manual tank loading” and manual vaporizer loading” are used for the
calibration of the dosing system.

3.14 - OTHER PARAMETERS
WARNING!
Changing the parameters described in this section must be done
by personnel trained by CISA. An improper use of this function
may damage both the sterilization process and personnel.
See the technical manual to set these parameters.
Select from the selection menu (par.3.3).
To use the numeric keyboard to modify the parameters and to use the needles to reach at the other
parameters.
Pushing to exit.
Pushing the display will show:

These parameters are changebles:
Use of one sterilizer at two doors like one door.
Act automatic opening of the unloading door side.
The selected button will be green color.
Pushing the display will show:


4.0 MAINTENANCE
4.1 GENERAL INFORMATIONS ABOUT MAINTENANCE
All information 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 for a
quickly maintenance.
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 (Par. 2.3).

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.


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 movement or high temperature.
After to have verified the real state of the interested component the skilled staff can , from the
main menu, to enter in the chapter “Technical functions” and restore the referring value for
the later maintenance (see par. 3.8).

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, recorders, printers, thermostats, pressure-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 manual valve gasket
TO CHECK probes and thermo resistances.
TO CHECK and in case lubricate the mechanical motion parts.
TO CHECK air compressor and possible restoration of the oil level.
TO CHECK pilot valves and replace ring or sealing ring
TO CHECK high vacuum mechanic pump and eventual oil level
TO CHECK high vacuum pump and eventual oil level
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 deposited wash with hot water and non corrosive or
neutral detergents. Do not 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 market 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. Repeat the washes.
CLEAN PANELS: use a soft cloth a non aggressive solution for stainless steel.
CLEAN GASKETS DOOR/S: use alcohol and talcum powder.
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.
For this operation to proceed in the following way:
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 - CLEANING OF THE FILTER DRAIN CHAMBER
1- open the door of the sterilization 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 sterilization
chamber. The cartridge is sideways that the cylindrical container.
5- clean the cartridge using compressed air or anti incrustation substances
6- assemble the cartridge on body
7- close the sterilizer executing the operations on the contrary
4.8 - 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.
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

4.9 - REPLACEMENT FUSES

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

4.10 - RESET THERMICS

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
4.11 - 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.
CAUTION! Replace the battery within one week from the

signalling.
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.
Switch off the autoclave. If the autoclave is switched off, switch it on for at least one minute
and than switch it off again.
Open the module of the panel using the key
Open the electric board with the suitable key
Open the compartment in the upper left of the CPU and carefully draw out the battey.
Remove the battery connector.
Connect the new battery, place it into the compartment and close the cover.
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.
4.12 - PRINTER
4.12.1 - REPLACING THE PAPER ROLL
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.
4.12.2 - REPLACING THE INKED ROLL (PIC.15)
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. 4
4.13 – EXTRAORDINARY MAINTENANCE
The extraordinary maintenance has to be done from CISA specialized technical people or authorized by
CISA.
If some components will be replace with some others not authorized from producer, CISA will not have
any responsibility in case of each kind of disadvantage.
4.14 - TROUBLESHOOTING
INCONVENIENT PROBABLE CAUSE ACTIONS TO TAKE
Insufficient vacuum Water shortage in the network Check the arrival from network or pump
Pneumatic vacuum valve is Clean the seat or replace the valve
leaking
Pneumatic valve (feeding Check the pilot electro-valve, in case replace the coil
water pump) is leaking
Non return vacuum valve is As above
leaking
The motor of vacuum pump is Check the pump.
tripped
Wrong temperature Defected temperature probe Check cable; check the status of the cable; replace it
Pressure out of range Door air inlet Check gasket; change it if necessary
Leak in the pipes Check pipes
Material in chamber with Dry all the materials in chamber
humidity in excess
Leackage in the pipes Ckeck the pipes
The motor of vacuum pump is Check the pump.

tripped
Door/s gasket Check the condition of the gasket and in case clean it and insert it
again in the seat.
Pump is noisy in the Cock anticavitation pump 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 Thermic of the pump tripped, Check the motor of the vacuum pump, verify that there is not
does not start (Referred to the electrical resistance to the rotation, if necessary, push the push-button of
diagram) the thermic, inside of the electric board restorating the contacts.
5.0 ACCESSORIES
5.1 - 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.
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.
5.2 - GRAPHIC RECORDER

Remove the chassis.
5.2.1 - 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.

5.2.2 - 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 obtain 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.
5.2.3 - 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 easily 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 writing 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 small 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.
5.2.4 - Pressure of the pen.

The pen should swing without 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.
5.2.5 - 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.
5.2.6 - 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.
5.2.7 - 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.
Autoclave CISA P a g . 107

5.3 - MODULAR BASKET

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

Technical appendix
The instructions about washing and packaging herebelow described only aim to indicate how
to best approach these activities and therefore are not complete and do not replace the rules
set out at Your center.
Washing, cleaning and packaging

Before sterilization all the parts of the material must be properly washed, rinsed with flat
water if possible and dried in a way as to decrease the microbe charge and remove the
dirt, oily substances and organic material as they may interfere with the sterilization
process.
The factors that determine a proper cleaning are: chemical (detergent), thermal (water
temperature) , time (immersion or soaking time) and mechanical (use of machines or
brushes). The devices to sterilize must be washed using a pH neutral detergent. For
surgical instruments a deprotenizing detergent must be used following the instructions set
out by the manufacturer . Detergents must be used following the instructions of use,
especially as far as dilutions are concerned. A product for which a dilution must be carried
out before it use, shall not be used in its pure state as it must be prepared in an
appropriate container following the instructions defined by the manufacturer.
Cleaning operations must be carried out separately from packaging operations as not to
alter the packing materials. This means that the material to sterilize must be packaged in a
different place from the washing area. The personnel carrying out this operation must be
protected with their personal protection devices ( e.g. gloves, gowns, glasses, facial
shields ) at all times during cleaning to avoid wounds and contacts with organic material or
detergents. Moreover, they have to pay particular attention to sharp and cutting tools.
In case of complex reusable medical devices which need disassembling, the user shall
follow the disassembling and assembling procedures defined by the manufacturer of the
devices, in order to allow an effective washing, cleaning and disinfecting processes.
Particular attention must be paid to: removing coarse dirt from the object; dipping the open
or disassembled instrument in a container where the proteolitic product or detergent is
placed for the contact time defined by the manufacturers; rubbing the object with
appropriate sponges, brushes or pipe cleaner inside the inner and outer parts, do not use
metal brushes nor abrasive products; rinsing with flat water if possible and drying.
After the drying, if defined by the device manufacturer, lubricating with appropriate pH
neutral products and then the instruments must be sprayed with a compressed air to
remove lubricant in excess. At the end of the washing, cleaning and lubricating phases, it’s
necessary to check visually and functionality the devices and verify the efficiency of the
instruments. Machine-operated cleaning must ensure that all instruments stay still on their
tray as they are not to hit nor damage one another. To prevent the albuminose substances
from coagulating during cleaning, the water temperature may exceed 45 °C only if the
cleaning product is in high concentration. Disinfection may be chemiothermal or thermal.
When using cleaning products, or combined products for cleaning and disinfecting, the
manufacturer’s instructions are to be strictly followed (time of action, concentration,
temperature).Only the right dosage guarantees a perfect result of cleaning and
disinfection, paying extra attention to materials.
An unsufficient dosage of alcaline product (false saving) implies the risk of corrosion as it is
avoided for pH values higher than 10,5. When using acid cleaning products, there may be
corrosion because of the presence of chlorine. This can be avoided only using flat water.
The instruments in coloured anodized aluminium shed their color with the ordinary
methods of machine cleaning and thus lose their encoding function. In case of very dirty,
encrusted instruments (clotted blood, secretion or other material), it may be necessary to

further clean manually or through ultrasounds. In this case it is necessary to strictly follow
the instructions for the delicate mechanical treatment of instruments for microsurgery.
In machine cleaning, during the rinsing stage, it is necessary to eliminate all the traces of
the cleaning stage or stains and colourings may appear on surgical instruments. the use of
a neutralizing product may help this procedure and improve the result of the rinsing stage.
What happened is that when treating surgical instruments in cleaning and disinfection
machines the best temperature for rinsing (for the following drying, among other things)
ranges between 70 and 95°C. If traces of corrosion appear the rinsing temperature must
range between 70 and 75°C. If flat water is used for rinsing it is possible to avoid stains
and corrosion without limiting the temperature.
The surgical instruments must be retrieved from the machine immediately after the end of
the programme. If the instruments, before being machine cleansed, are dipped into a
cleaning and disinfecting solution, in order to avoid foam formation in the machine a rinsing
stage must be carried out or a foam-controlled product is to be used. Instruments having
long or narrow holes, such as metal catheters, metallic aspirators, special pipes, etc. must
be rinsed also inside. The machine treatment of instruments for microsurgery and dental
instruments just as delicate must be carried out in automized machines only if a safe
clamping of instruments during the working process. Handles and particular hinged
instruments may be machine treated if the manufacturer allows for such a method and if a
safe clamping is ensured.
As soon as the machine programme is over, it is necessary to carry out a proper treatment
with an appropriate spray to remove the humidity that may have penetrated inside the
instruments. Rotating dental instruments (drills, milling cutters and abrasive bodies) are
suitable for machine treatment only partially. The ultrasound treatment is preferable. The
same can be said of instruments for roots.
Small mirrors covered with rhodium vapour may be machine treated. it is important to
make sure that instruments having inside holes are well cleaned inside, too. For
chemiothermal processes the temperature must not exceed 60°C.
For cleaning in an ultrasound bathtub the surgical instruments must be placed in an open
position on the appropriate sterilization baskets. Attention must be paid so as to avoid that
neither the sterilization baskets nor big-sized instruments (hands of lead, other baskets)
cause areas of shadow for the ultrasounds. The hot water without additives has no
satisfying cleaning results. It is thus necessary to add an appropriate product for cleaning
to it . The manufacturer’s instructions must be respected as to concentration and
temperature.
The temperature of the solutions of cleaning in the ultrasound bathtub should be at least
40°C, or else the cleaning effect is not guaranteed. A higher temperature helps the
degasification of the cleaning solution and facilitates the action of the ultrasound treatment
.
The appropriate use of a suitable product does not produce coagulation of albuminose
substances, even at higher temperatures. At temperatures ranging between 20 and 25°C,
it is possible to use only those cleaning and disinfecting products provided for use at these
temperatures. An excessive concentration of dirt in the ultrasound bathtub damages
cleaning. Therefore the solution is to be renewed according to the intervals set out by the
manufacturer. What happened was that the times of ultrasound treatment ranging between
3 and 5 minutes and at frequencies of at least 35 Khz may be considered sufficient
(respect the manufacturer’s instructions). The cleaning ultrasound bathtub must be filled
following the manufacturer’s instructions (water quantity).
To ensure a perfect cleaning the instruments must be completely covered by the cleaning
solution. The instruments cleaned by ultrasounds must then be rinsed accurately by hand
or machine.
This rinsing must be carried out with clean water whose quality must be at least equal to
that of drinking water. It would be preferable in any case to use flat water to avoid
formation of stains. At the end of the rinsing process the instruments must be immediately
and carefully dried. The microinstruments must be placed on special supports to avoid
their being damaged. To avoid damaging the surfaces and the weldings of dental
instruments the ultrasound bath must not contain any acid substances to remove the
cement .Handles, hinged parts and waterwheels must not be ultrasound treated.
Rotating dental instruments are to be treated only with appropriate cleaning and
disinfecting products.
They are to be placed on the special supports provided for them. By doing this the
instruments do not damage one another through direct contact (for example, through live
corners, diamond-like grains, etc.). After quickly rinsing with water and immediately drying
them, the rotating dental instruments must be treated with a product against corrosion and
which is resistant to sterilization.
Accessories (valves, lids, PE pliers, catheters) can be ultrasound cleaned. Packaging of
the objects and protections aim at preserving the sterility of the treated material until they
are used, must allow the penetration and contact of the sterilizing medium with the surface
of the object, at the moment of the opening must decrease the risk of contaminating the
content, must be practical and handy .The objects to sterilize can be packaged individually
or assembled,. In this latter case it is correct to follow the orientation of the packaging for
single necessity (medication set, for operation) rather than the quality packaging that offers
fewer healthy guarantees.
Packages must be small-sized and once opened must be used completely or re-sterilized.
Before packaging: make sure the material is clean, undamaged, dry, disassemble the
assembled parts by removing caps and lids, protect the tips of needles and sharp
instruments, place plastics and rubbers so as to preserve their original shape, roll up the
tubes or the protections that are very long, if possible, without creating tight spots. The
packaging technique must allow for the opening of the package without compromising the
sterility of the objects that it contains. When packaging do not use pins nor paper clips to
close packages. Packaging in pouches or tubolars in Tyvek® matched OPA is
recommended for plasma sterilization and for single positions or small and medium-sized,
for sets of surgical instruments. Methods of preparation imply the choice for an envelope
shape or tubular that is appropriate, considering that the content must not occupy more
than ¾ of its volume. Moreover, the content must be placed so as to guarantee the right
opening and extraction when it is used, the handle of the instruments must be readily
accessible.
Make sure that pointed or sharp material is protected by plastic supports and that all
pouches are sealed at the edges by thermal welding machines leaving a 5 cm margin and
at least a 1 cm edge. This latter in any case must never be below 6 mm and above 12 mm.
of the continuous or multiple type.

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CISA S.p.A. - Manual of Use and Maintenance - Version 1.

MANUAL OF USE AND MAINTENANCE

Tel. +39 (06) 91 14 37.1

2.0 MANAGEMENT OF THE AUTOCLAVE ..................... 37

Autoclaves CISA Pag.2

3.0 TECHNICAL FUNCTIONS ........................................ 62

4.0 MAINTENANCE ...................................................... 95

5.0 ACCESSORIES ....................................................... 105

TECHNICAL APPENDIX ...................................................... 109

Autoclaves CISA Pag.3

INDEX OF THE PICTURES

Autoclaves CISA Pag.4

NOT ES ON THE USE OF THIS MANUAL

DEST INAT ION OF USE

Autoclaves CISA Pag.5

NOTICES FOR SAFETY

Caution must be done to open the electric board and connector

The “WARNING” sign is for specific information on the right use

Autoclaves CISA Pag.6

Autoclaves CISA Pag.7

The maintenance and repairing of the sterilizer must be

The use of unauthorized accessories may be dangerous and cause the

Electric power must be shut off before repairing or upkeeping the

For any reason must not be modified or tampered all safety

Please do not tamper with used-up cartridges. In case you have to

The loading area of the sterilizer must be kept clean so as to avoid

Autoclaves CISA Pag.8

A biological indicator must be used to check the sterilization cycle. In

Do not use biological indicators which are not specifically manufactured

Autoclaves CISA Pag.9

Sps equipement dimension : 1700 x 1850 x 1094 mm (W x H x D)

Autoclaves CISA Pag.10

AUTOCLAVE SERIE 640 SPS

AUTOCLAVE SERIE CISA 640 SPS

Autoclaves CISA Pag.11

LOAD SIDE CONTROL PANEL LEGENDA

1 Touch screen (Display) 7 Open door pushbutton (manual) /

Autoclaves CISA Pag.12

UNLOADING SIDE CONTROL PANEL LEGENDA

7 Closure door pushbutton 11 Led alarm

Autoclaves CISA Pag.13

1.0 GENERAL INFORMATIONS

1.2 - Other conditions

Autoclaves CISA Pag.14

ID N° Activity Manufacturer End User

18 Management of nonstandard products X

Autoclaves CISA Pag.15

Autoclaves CISA Pag.16

1.5 - Frequently asked questions

Q: What kinds of devices can CISA SPS sterilize?

Q: Why is it impossible to sterilize devices made of cellulose with CISA SPS?

Q: Is it necessary to pay particular attention to the placement of loads?

Q: How long does a sterilization cycle last?

Autoclaves CISA Pag.17

Q: Where must the biological indicator be placed to test the cycle?

Q: Is it necessary to use chemical indicators inside the envelopes?

1.6 - Kind of materials

Not allowed items and materials:

Autoclaves CISA Pag.19

1.7 – Washing, cleaning and packaging

Cleaning and rinsing

For further information see technical appendix.

• Inside the sterilization chamber it is advisable to use only wire baskets

Tube in teflon whose diameter is inclusive between 2 and 20 mm and having a