sterilizzatori a vapore

Infection Control System

Hospital ApplicationSTERILIZZATORI A VAPORE

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STEAM STERILIZER Hospital Application


Infection Control System

High quality equipment for Hospital application and patients’ safety, an

innovative technology to guarantee optimum results at low running costs.

HOSPITAL STEAM STERILIZER

3STEAM STERILIZER Hospital Application


TECHNOLOGYDeveloped and updated technology for steam sterilizers. This technology is based on accumulated experience,

which CISA has been acquiring since 1946, as manufacturers of such machines, introducing continuous updates, to

make them more advanced, efficient and powerful.

POWERFUL VACUUM SYSTEMUsing a multi-stage water ring vacuum pump, the sterilizer features deep and stable vacuum which guarantees

excellent air removal in pre vacuum and excellent drying in post vacuum.

The vacuum pump is mounted on a vibration-damping frame to reduce noise with high safety protection. A water

recovery system can be added as an option to reduce water consumption.

ENERGY SAVING SYSTEMCISA Sterilizers are designed to help energy saving without affecting performance with an advanced engineering

solution to define optimum use of power and energy saving.

Pre vacuum: air removal

Using Vacuum/Steam pulsation, the air is removed to guarantee good

steam penetration inside the load. The type and quantity of pulsations are

dependent on load and on packing material.

POST VACUUM PHASE: DRYING PHASE QUALITYCISA technology will improve drying quality thanks to stable and high

vacuum values with less time needed for drying.

COST SAVING MACHINEHospital steam sterilizers have very low running costs as well as very low maintenance costs. The synergy of these

characteristics makes CISA’s machines leading products in terms of cost savings.

EXCELLENT INSULATIONThe pressure vessel is covered with high thickness insulation material which controls the heat loss; it also increases

the quality of the sterilization cycle, reducing the natural temperature drops. The quality of insulation material is

important for safety reasons since the surface temperature of the sterilizer can be in contact with operators. The

temperature never exceeds 45 degrees during sterilization phase.

ENVIRONMENTAL FRIENDLY SOLUTIONEnviromental system which guarantees full respect of the environment, using different solutions for thermal and

noise protection, drainage and air outlets protection and low electromagnetic emissions.

DESIGN & INSTALLATIONThe steam sterilizers for Hospital application are customizable in terms of functions and design; CISA helps the

customer in taking the decision with full care for all requirements and applications. The configurations of the

machines are as follows:following:

• Single- or double-door application; automatic or

manual, vertical or horizontal movement.

• Loading/Unloading.

• Stainless steel closure

• Rectangular chambers

• Recessed through one, two walls or free standing

• Control & printing possibilities from one or both

sides

• Heating solutions.

The machine is designed with PLC microprocessor control for higher safety and guaranteed controllability;

modern control system and high quality functioning elements guarantee best performance and high

reliability of the sterilizer. CISA R&D engineers used advanced design to optimize the machine for the use of

laboratories and research centers as well as industrial applications by working on quality and reliability and

paying high attention to safety and post installation. The machineis built with highest quality components

for perfect hygiene, perfect operation, high durability and maximum safety.

The machine is designed with a user-friendly system for operators and in full compliance with environmental

requirements and low noise emissions. Installation and maintenance of the machine are smooth, clear and

defined by step by step procedures. Compact architecture and high reliability, are the core features of all

our machines.

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CONSTRUCTION The highest quality of stainless steel is used in the

construction of the machine. The possibility to use

AISI 316 Ti (chrome-nickel-molybdenum-titanium)

for chamber, jacket and door(s) guarantees the high

performance and high durability of the pressure vessel.

The frame and front panels of the machine are

manufactured using stainless steel material 304L.

Hydraulic plant and pipes are manufactured using

stainless steel 316L. Steam Generator is manufactured

using stainless steel 304L, upgradable to 316L.

A full stainless steel jacket surrounds the chamber.

Pressure vessel and steam generator as well all steam

pipes are insulated using insulation material with high

efficiency that reduces heat loss and stabilizes the

temperature inside the pressure vessel so as to improve

quality of sterilization cycles. Reducing heat loss also

increases safety for the operator by reducing the surface

temperature of the sterilizer.

Non-toxic,

fire-resistant

insulation foam,

with extremely

low thermal

conductivity

and no release

of particles.

The chamber

is electrically

polished up

to Ra of less than 0.2 Micron (Mirror finish electrolytic

polishing treatment).

All welding for the pressure vessel is robot controlled

and checked and guaranteed to be homogenous using

advanced control methods.

The chamber is designed to withstand pressure, from

absolute vacuum up to +3.5 bars; factory tested at 5.80

bars. The jacket is tested at 6.60 bars.

CONTROL INTERFACE The control interface is based on a modern design with a smooth surface for hygiene and easy cleaning and can

be installed on the loading side, the unloading side or both, The control interface is provided with standard 7 Inch

touch screen upgradable to 10 Inch, built-in dot matrix printer, optional chart recorder, emergency button, and door

control buttons.

The control interface is equipped with pressure gauges for chamber, jacket or steam generator, is installed at eye

level position to enable good view and easy control.

Control system & user interfaceThe touch screen gives control the following functions:

• Selecting cycle and packing type

• Self-check display before starting the cycle and confirmation page.

• Display of cycle status, parameters (temperature, pressure and time)

• Pages for set-point cycle follow up and real time diagram display.

• Audio/visual alarms display with alarm history.

• F0 Calculation.

The control system is composed of a PLC microprocessor based systems with sensors for data input using high

precision pressure and temperature sensors.

Operators access level controlEvery operator can have his/her own identity using CISA system with password and pre-defined access level; the

levels can be customized for each operator with access to multiple functions.

Operator name will be printed and kept in the system for external storage, or transferred to external supervision

system software.

AlarmsAudio visual alarms are defined for operator warning; the alarms list includes multi level alarms with clear message

notification; alarm levels are configured based on the level of importance to stop the machine or stop the cycle or

just warning without affecting running cycle. Alarm lists are complete for safe and perfect operation for operators

and machines. The alarms history can display all alarms that occurred in last 90 days.

Alarms are also indicated on unloading side in case of double doors execution.

The end of cycle alert is included for alerting the user for the unloading process.

• Maintenance program for preventative maintenance

• Operators access level control (password protected)

• Calibration & technical pages (password protected)

• Programming new cycles or modifying standard cycle

(password protected)

• Type of steam heating selecting

• Programmable automatic Start up and shut off time

• Alarm Messages are in clear test and not code figures

• Door open/closure management

• Troubleshooting pages



BUILT-IN PRINTER & CHART RECORDERThe built-in printer for cycle documentation includes: date and time printing with hospital name, lot number and

operator name, selected cycle, parameters values in different cycle phase that can be programmed as per customer

requirements, phase by phase display, total cycle time and cycle results (valid or invalid) as well as printing alarms

during cycle execution. A chart recorder is optionally added with independent sensors with validation and

comparison between printed and recorded data.

VALIDATIONAll pre-programmed cycles are validated as per EN285 standards. The customer can also run validation using

the included validation ports for customer cycles according UNI EN ISO 17665-1.

STEAM GENERATIONThe machine can be configured using one of the following solutions concerning steam generation:

(E): Built-in steam generator electric heating

(V): External steam supply from hospital steam network (domestic steam).

(EV): Combination between (E) & (V) which enable the user to select type of heating from touch screen as internal

(E) or external (V) without hardware interface.

(SV): Steam to steam converter to generate medical quality of steam from service steam using the built-in heat

exchanging facility.

(ESV): Combination between (E) & (SV) with same selection method as explained above.

MAINTENANCE Most of the Sterilizers are designed to enable one-side maintenance access. The components inside are installed in

such a way as to guarantee easy access for maintenance and with a good engineering layout for better performance .

Electric components are installed in an electric box which is sealed to guarantee higher

safety for electric components and less technical problems compared to open electric

parts as per protection level IP55.

RS232 and RJ45 are also installed for external connection, software upgrade, REAS

connections.

The Steam generator is manufactured in stainless steel AISI 316 L with powerful stainless

steel elements, and stainless steel water pump and optionally break tanks.

The steam to steam converter is manufactured using stainless steel 316 L.

External steam is channelled into a built-in 5 micron steam filter for purification of inlet

steam.

An external steam connection set, consisting of pressure regulator, cutoff valves, pressure

gauge and separators are optional items that can be added.

The steam generator is equipped with auto cleaning and flushing for high reliability and

better functionality.

Steam generator, converter and steam pipes are insulated using thermal insulation material for controlling heat loss..

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QUALITY & SAFETY CERTIFICATES

CISA sterilization units conform to the requirements of the European standard EN 285 and to the different standards EN 61010-1, EN 61010-2-040, EN 60204-1. The machines are also CE marked according to the EEC directive 93/42 for medical devices. Validated according to UNI EN ISO 17665-1. The test approval of pressure vessels follows the requirements of the country of destination and PED (DL 97/23/CEE) for pressure vessels certification.

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MULTI LANGUAGE TOUCH SCREENMost world languages are pre-installed in the machine: users can easily choose them from the touch screen,

including english, italian, French, Spanish, Arabic, Russian, Portuguese, German, Turkish, Polish, Chinese, Greek,

Romanian, Korean, Bulgarian and others.

Touch Screen language selection

Touch Screen insert Operator Code Touch Screen for alarms history

SERVICE & MAINTENANCE PROGRAM The touch screen is also equipped with pages for periodic preventive maintenance, enabling a safe functioning of

the machine, and an auto maintenance program for steam generator flushing with user acceptance; technical pages

are equipped in the system for calibration and parameter control.

Easy and friendly troubleshooting pages are added for easy maintenance and service.

Maintenance and technical pages are protected with password: only authorized persons have access to them.

START UP TIME & STAND BYThe machine can be programmed using the touch screen interface for early starting up which also enables a

warming cycle and an auto vacuum leak test cycle to start before early morning staff arrival. There is also the

possibility to program an early morning B&D test cycle if automatic loading is provided. Stand-by or shut-off times

can also be programmed for end of day operations without staff waiting.

AIR DETECTOR AND DEGASSINGThe machine can be equipped with air detector as an optional feature. This will improve the functionality of the

machine using guaranteed steam concentration with less air bubbles. Degassing to remove NCG (non-condensable

gases) from steam is an extra option that can be added.

AUTOMATIC SLIDING DOOR(S)Automatic Sliding doors enable safe & smooth door opening/closure using a pneumatic system.

The movement can be: (SV ): vertical sliding door(s)

(SO): horizontal sliding door(s).

GASKET AND SEALThe sealing of the door is guaranteed by the dynamic movement of the gasket

obtained through introduction of steam in the seat of the gasket. The internal

surface of the seat has a roughness degree N6 (grinding) to provide perfect

gasket adherence. The perfectly rounded corners prevent wear and tear on

the gasket itself. Vacuum is performed at the end of the cycle to obtain the

separation of the gasket from the door, for an easy opening of the same

avoiding damage to the gasket itself and it does not need maintenance and lubrication.

DOOR EXECUTION, SAFETY CLOSURE & INTERLOCK SAFETYThe machine can be executed in single door (1P) or in double doors pass through

(2P). The machine is provided with high safety features including for door(s) the

following:

• Both doors in case of double doors execution can not open at the same

time, as an interlock safety device prevents cross contamination.

• The safety lock does not enable door opening if a cycle is running or if

the chamber is pressurized.

• No cycle start or steam inlet until the door(s) have been checked and are



STERILE AIRAt the end of cycle sterile air is injected inside the chamber

to obtain uniform pressure, using an HEPA R14 air filter.

SAFETY FEATURESAccording to international and European standards,

the machine features a high safety program with a self-

test for auto check.

NETWORKING & MANAGEMENT SOFTWARE

NCS System for central data monitoring, archiving and reporting using real time data

interface.

OPTIONALS

An additional touch-screen can be installed upon request on the

unloading side in the double door device.

The dual touch-screen can customize the settings for the control of

the machine; one of the two sides of commands can act as a main.

ADDITIONAL TOUCH-SCREEN

CISA sterilizers can be equipped on the load side - or, as an optional,

on the unloading side - with a bigger touch-screen 10 Inch interface

for a better view of the display commands and consequently for

greater usability.

TOUCH SCREEN 10’’

All discharges (vacuum pump, chiller, chamber and jacket condenses)

are conveyed in a container of stainless steel with thermostat to

control the temperature before exhaust in the pipeline.

The device senses the discharge temperature and adding service

water, this will be maintained at less than 60° C and will thus be

suitable for every supply line and in any case adjustable to better

manage the consumption of service water.

DRAIN COOLING DEVICE

DRY VACUUM PUMP SYSTEM The innovative CISA DRY system for the production of high vacuum

does not need water for its operation by annulling common service

water consumption.

The high performance pump enables more extreme vacuum

conditions to be generated inside the sterilization chamber,

compared with traditional liquid ring pumps. Inside the chamber, the

vacuum system achieves a 99% air removal.

In such conditions, steam penetration tests conducted on hollow

bodies have registered excellent results.

The device, therefore, compared to those driven by traditional liquid

ring pump, presents considerable advantages, among which:

• ZERO CONSUMPTION OF WATER FOR THE PRODUCTION OF

VACUUM

• NO MACHINE DOWNTIME for the maintenance and repair and/

or replacement of the vacuum pump liquid ring subject to the

aggression of hard water.

tightly closed.

• For operator safety: door closure is stopped if an obstacle is found in the way of closure.

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STEAM GENERATOR UPGRADE CISA provides the customer the possibility of choosing the electric

power of steam generator in order to shorten cycle times, especially

the preheating times.

This system makes it possible to save about 15% of the total cycle

time at the expense of greater power consumption.

The power of the generator varies depending on the model of the

sterilizer.

UPS BACKUP CONTROL SYSTEM The UPS backup system is connected to the PLC and the touch-screen

and allows you to accomplish the cycle in case of sudden surges or

power failure. The cycle remains valid as long as the conditions that

guarantee the cycle performances are not compromised.

OPTION OVERTURNED MACHINE Depending on installation needs and to facilitate the operations

of ordinary and extraordinary maintenance the equipment can be

configured in a standard or inverted module.

In the first case the chamber is placed at the left (looking from the

front side) and the technical module to the right, in the second case

the chamber is placed on the right side and the technical module is

placed on the left.

DEGASSER The degasser is a technology that allows you to remove the presence

of non-condensable gas in the steam released into the sterilization

chamber; the water supply of the electrical steam generator

is accumulated in a tank and is heated up to 70° C to allow the

liberation of the gas dissolved in water.

This ensures a higher quality of saturation of the steam that comes

into contact with the material to be sterilized.

The introduction of this technology is subject to the installation of

an air gap system in the treated water supply.

The system is designed to disconnect water to protect the

functionality of the surge pressure from the water supply.

This system in fact, according to the service water and/or treated

matter, carries the water to an open break tank and brings it back to

atmospheric pressure, to avoid back-flow into the supply line.

AIR GAP SYSTEM

The water used by the liquid-ring vacuum pump is collected in a

break tank, where it is cooled by adding fresh water coming from

the supply line and fed back into the circulation in the service of the

pump itself.

This system saves 50% of the service water used by the liquid-ring

vacuum pump, thus optimizing management costs.

WATER RECOVERY DEVICE



DIFFERENT STERILIZATION CYCLES

The autoclave can be fitted with different cycles depending on its

application; those cycles may include part or all of the following

cycles:

1. Sterilization cycle at 134°C for general porous loads, empty glass

ware and generally all things that are temperature-proof

2. Sterilization cycle at 134°C for general solid loads, specifically for

surgical instruments, empty glass ware and generally all items

that are temperature-proof.

3. Sterilization cycle at 121°C for general porous loads, empty

glassware and generally all things that are temperature-proof

4. Flash cycle at 134°C

5. Steam penetration test cycle (Bowie & Dick)

6. Vacuum leak test

7. Open cycle (from 01 to 60 programmable cycles; must be

validated; password protected)

The system facilitates material loading/unloading operations. In fact

this device allows the autoclave to be loaded or unloaded without

an operator being present.

Each individual system consists of a device placed in front of each

machine, detecting sensors and coupling devices external trolley,

push-button actuation and safety devices.

The pneumatic mechanism and the electronic control by PLC

guarantee a high reliability of the system.

This group is entirely controlled by the PLC installed on the autoclave.

A series of electronic devices prevents jams that may occur or any

injuries to personnel working in the proximity.

SYSTEM FOR AUTOCLAVE AUTOMATIC LOADING / UNLOADING

CYCLES AND VALIDATION All pre-programmed cycles loaded in the sterilizer are validated

cycles and the software itself is a validated software; the re-validation

of the cycles at customer end is possible and can be executed as

per hospital requirements.

LOADING ACCESSORIES Accessories for loading and unloading are available for each model

with the selection of: internal trolley (shelving unit/transfer carriage),

external trolley (loading/unloading), automatic loading device

automatic unloading device, electric height-adjustable loading/

unloading trolley.

Loading devices are manufactured in stainless steel with sizes and

loading mechanisms that enable full use of chamber and smooth

operation with less personnel activity. Chamber rails can be added

as an option.

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GLOBO SERIES 450

MODEL CHAMBER SIZE (W*H*D) DIMENSIONS 1P - 2P (W*H*D) LT - US

4570 452 x 660 x 720 1100 x 1850 x 998 - 1028 207 – 3

4510 452 x 660 x 1000 1100 x 1850 x 1270 - 1308 296 – 4,5

4512 452 x 660 x 1280 1100 x 1850 x 1558 - 1588 370 – 6

GLOBO SERIES 420


4270 452 x 452 x 700 903 x 1850 x 998 - 1028 144 - 2

4210 452 x 452 x 1000 903 x 1850 x 1278 - 1308 199 – 3

4212 452 x 452 x 1280 903 x 1850 x 1558 - 1588 255 – 4

GLOBO SERIES 3600


3670 330 x 660 x 720 903 x 1850 x 998 - 1028 157 – 2

3690 330 x 660 x 1000 903 x 1850 x 1278 - 1308 218 - 3

GLOBO SERIES 3000

MODEL CHAMBER SIZE (W*H*D) DiMENSIONS 1P-2P (W*H*D) LT - US

3270 322 x 322 x 720 700 x 1850 x 998 - 1028 73 - 1

3290 322 x 322 x 1000 700 x 1850 x 1278 - 1308 101 – 1,5

ModelsAll of the sizes and measurements below can be changed according to the different configurations and applications

of the machines.



GLOBO SERIES 2000


2015 1050 x 2000 x 1600 2800 x 2750 x 2100 - 2130 3358 – 42

2020 1050 x 2000 x 2000 2800 x 2750 x 2500 - 2530 4198 – 54

2025 1050 x 2000 x 2500 2800 x 2750 x 3000 - 3030 5247 – 72

GLOBO SERIES 1350


1315 1050 x 1350 x 1600 2800 x 2100 x 2100 - 2130 2268 – 28

1320 1050 x 1350 x 2000 2800 x 2100 x 2500 - 2530 2835 – 36

1325 1050 x 1350 x 2500 2800 x 2100 x 3000 - 3030 3544 – 48

GLOBO SERIES 1400


1410 660 x 1490 x 1000 1750 x 2350 x 1430 - 1470 982 – 12

1413 660 x 1490 x 1300 1750 x 2350 x 1740 - 1770 1277 – 16

1415 660 x 1490 x 1600 1750 x 2350 x 2040 - 2070 1572 – 20

1420 660 x 1490 x 2000 1750 x 2350 x 2440 - 2470 1964 – 24

1425 660 x 1490 x 2500 1750 x 2350 x 2940 - 2970 2455 – 28

GLOBO SERIES 1000


1110 660 x 1120 x 1000 1750 x 2100 x 1430 - 1470 738 – 9

1113 660 x 1120 x 1300 1750 x 2100 x 1740 - 1770 959 – 12

1115 660 x 1120 x 1600 1750 x 2100 x 2040 - 2070 1181 – 15

1120 660 x 1120 x 2000 1750 x 2100 x 2440 - 2470 1476 – 18

1125 660 x 1120 x 2500 1750 x 2100 x 2940 - 2970 1844 – 18

GLOBO SERIES 640


6464 660 x 660 x 720 1424 x 1850 x 998 - 1028 313 – 4

6410 660 x 660 x 1000 1424 x 1850 x 1278 - 1308 434 – 6

6412 660 x 660 x 1280 1424 x 1850 x 1558 - 1588 556 – 8

6415 660 x 660 x 1600 1424 x 1850 x 1878 - 1908 695 – 10

6420 660 x 660 x 2000 1424 x 1850 x 2278 - 2308 868 – 12

Cisa ProductionHeadquarter

Via Enrico Mattei

55100 Lucca, Italy

ph. +39 0583 1538105

e-mail. [email protected]

[email protected]

www.cisagroup.it

Cisa ServiceVia Veneto, 32

35020 Due Carrare, Padova, Italy

ph. +39 049 91 25 991

fax +39 049 91 25 992

www.cisaservice.com

Cisa Asia Office190 Middle Road

#19-05 Fortune Centre

188979 Singapore

ph. +65 6826 1065

mob. +65 919 09122


Cisa Brasile Ltda.Rua Dona Francisca, 8300

Distrito Industrial Bloco I – Mòdulo 2

CEP 89239 – 270 Joinville

SC Brasil

ph. +55 47 3801 9090


Cisa Middle East Ltd.Rabyieh

Tabreez Street

Villa 19 – Amman

Jordan

ph. +962 6 556 3091

ph. +962 6 556 3092

fax +962 6 556 3093


Versione 3.2.b

sterilizzatori a vapore

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