specifications. amaro 5000 & steri 21 md009_04 en. a. j. costa (irmÃos), lda. desde 1953 ao...

10
8/16/2019 Specifications. Amaro 5000 & Steri 21 MD009_04 en. a. J. COSTA (IRMÃOS), LDA. Desde 1953 Ao Serviço Médico-H… http://slidepdf.com/reader/full/specifications-amaro-5000-steri-21-md00904-en-a-j-costa-irmaos-lda 1/10    A. J. COSTA (IRMÃOS), LDA. – Desde 1953 ao Serviço Médico-Hospitalar Estrada das Ligeiras. Lote 10. Alto da Bela Vista. 2735-337 Cacém. Portugal. E-mail: [email protected] om. URL:www.ajcostairmaos.com Geral: Tel. (+351) 214 266 500. Fax (+351) 214 262 421 Dep. Com. [Eliwell, Jumo, Wika]: Tel. (+351) 214 266 502 . Fax (+351) 214 266 507 Assistência Técnica: Tel. (+351) 214 266 505 Dep. Com. Bombas [SIHI, Busch]: Tel. (+351) 214 266 508 . Fax (+351) 214 266 506 1 Specifications Amaro 5000 & Steri 21

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Page 1: Specifications. Amaro 5000 & Steri 21 MD009_04 en. a. J. COSTA (IRMÃOS), LDA. Desde 1953 Ao Serviço Médico-Hospitalar

8162019 Specifications Amaro 5000 amp Steri 21 MD009_04 en a J COSTA (IRMAtildeOS) LDA Desde 1953 Ao Serviccedilo Meacutedico-Hhellip

httpslidepdfcomreaderfullspecifications-amaro-5000-steri-21-md00904-en-a-j-costa-irmaos-lda 110

983117983108983088983088983097983087983088983092 983109983118

A J COSTA (IRMAtildeOS) LDA ndash Desde 1953 ao Serviccedilo Meacutedico-Hospitalar

Estrada das Ligeiras Lote 10 Alto da Bela Vista 2735-337 Caceacutem Portugal E-mail infoajcostairmaoscom URLwwwajcostairmaoscom

Geral Tel (+351) 214 266 500 Fax (+351) 214 262 421 Dep Com [Eliwell Jumo Wika] Tel (+351) 214 266 502 Fax (+351) 214 266 507

Assistecircncia Teacutecnica Tel (+351) 214 266 505 Dep Com Bombas [SIHI Busch] Tel (+351) 214 266 508 Fax (+351) 214 266 506

1

Specifications

Amaro 5000 amp Steri 21

8162019 Specifications Amaro 5000 amp Steri 21 MD009_04 en a J COSTA (IRMAtildeOS) LDA Desde 1953 Ao Serviccedilo Meacutedico-Hhellip

httpslidepdfcomreaderfullspecifications-amaro-5000-steri-21-md00904-en-a-j-costa-irmaos-lda 210

983117983108983088983088983097983087983088983092 983109983118

A J COSTA (IRMAtildeOS) LDA ndash Desde 1953 ao Serviccedilo Meacutedico-Hospitalar

Estrada das Ligeiras Lote 10 Alto da Bela Vista 2735-337 Caceacutem Portugal E-mail infoajcostairmaoscom URLwwwajcostairmaoscom

Geral Tel (+351) 214 266 500 Fax (+351) 214 262 421 Dep Com [Eliwell Jumo Wika] Tel (+351) 214 266 502 Fax (+351) 214 266 507

Assistecircncia Teacutecnica Tel (+351) 214 266 505 Dep Com Bombas [SIHI Busch] Tel (+351) 214 266 508 Fax (+351) 214 266 506

2

1 GENERAL INFORMATION

11 Technical Introduction

A J Costa (Irmatildeos) Lda steam sterilizers are designed to cover a large field of applications for

hospitals and medical centers as well as pharmaceutical and biotechnological industries and researchlaboratories They meet the latest features in state-of-the-art sterilization technology

A J Costa (Irmatildeos) Lda sterilizers are available as multi-functional steam sterilizer with pre-vacuumand post-vacuum technology for healthcare facilities applications and gravity capabilities as laboratoryliquids steam sterilizer

All sterilizers are available for installation either recessed through wall or as freestanding models Asbuyerrsquos option freestanding sterilizers are cabinet mounted with stainless steel cover panels

A J Costa (Irmatildeos) Lda 50x50(cm) cross-section sterilizers for special application biosafety P3 typelaboratories have manual hinged doors AJC 50x50(cm) amp 70x70(cm) cross-section sterilizers haveautomatic vertical sliding power doors Larger units AJC 70x112(cm) cross-section sterilizers are

equipped with power automatic horizontal sliding doorsA J Costa (Irmatildeos) Lda sterilizers feature a microcomputer control system with a color touch screendisplay interface and a digital printer The microcomputer controls the steam sterilizers with a pulsingpressurevacuum air removal system Visual indicators monitor all cycle phases with audible andvisual cycle completion indicators It is designed for efficient sterilization of heat- and moisture-stablewrapped or unwrapped instruments and materials textiles heat sensitive materials instruments incontainers dry goods laboratory glassware flask liquids and laboratory contaminated waste goods

Pre-vacuum configuration sterilizers are equipped with pre vacuum gravity liquid leak test and dailyair removal (Bowie-Dick) test cycles

12 Construction Specifications

121 Frame

The sterilizer pressure vessel and components are secured to a welded structural frame The frame isconstructed in stainless steel It is mounted on threaded leveling screws with supplemental stainlesssteel weight distribution footpads The frame is mechanically rectified by a CNC precision-machine forperfect alignment of all mounted devices

122 Sterilizer Pressure Vessel

The steam sterilizer is prepared to operate with saturated steam as sterilizing agent condensatefree 97 to 100 vapor quality and working at a temperature range from 105ordm C of up to 137ordm C andpressure up to 330 kPa

The pressure vessel is a shell parallelepiped shape composed by the sterilization chamber and a fullintegral surrounding jacket

1221 Chamber

The chamber is made of AISI 316L stainless steel with an internal high finish luster obtained bymechanical polishing It is constructed with 2 sheet-metal U-shaped Chamber is of entirely weldedconstruction with interior longitudinal corners that are radiused The chamber is fully jacketed Steambaffles are positioned in the chamber to minimize wetting by condensate and insure proper steam

distribution and equal load surface heating The chamber drain system is on the center of the

8162019 Specifications Amaro 5000 amp Steri 21 MD009_04 en a J COSTA (IRMAtildeOS) LDA Desde 1953 Ao Serviccedilo Meacutedico-Hhellip

httpslidepdfcomreaderfullspecifications-amaro-5000-steri-21-md00904-en-a-j-costa-irmaos-lda 310

983117983108983088983088983097983087983088983092 983109983118

A J COSTA (IRMAtildeOS) LDA ndash Desde 1953 ao Serviccedilo Meacutedico-Hospitalar

Estrada das Ligeiras Lote 10 Alto da Bela Vista 2735-337 Caceacutem Portugal E-mail infoajcostairmaoscom URLwwwajcostairmaoscom

Geral Tel (+351) 214 266 500 Fax (+351) 214 262 421 Dep Com [Eliwell Jumo Wika] Tel (+351) 214 266 502 Fax (+351) 214 266 507

Assistecircncia Teacutecnica Tel (+351) 214 266 505 Dep Com Bombas [SIHI Busch] Tel (+351) 214 266 508 Fax (+351) 214 266 506

3

chamber designed to disposes condensate to waste and equipped with safety systems to preventsterilizer effluent from entering the sterilization chamber

An automatic steam condenser exhaust system reduces temperature of exhaust steam flowing to thedrain

The automatic condensing system consisting of a stainless steel heat exchanger converts chambersteam to condensate and disposes condensate to waste Cooling water flow is regulated by the wasteline temperature control system to minimize water usage

On double door units the end frame bulkhead of the chamber are constructed of solid AISI 316Lstainless steel and entirely welded on the pressure vessel

On single door units back of chamber is fitted with welded 316L stainless-steel head

The complete pressure vessel is then mechanically rectified and all mechanical dimensions arecontrolled by a CNC precision-machine

1222 Jacket

The jacket is constructed of AISI 304L stainless steel It is constructed with 2 sheet-metal U-shapedparts Directly on those 2 sheet-metal strength points are mechanical shaped and the jacket is ofentirely welded mounted and welded to the chamber giving reinforcement according to the cross-section of the chamber The jacket along with the chamber is designed to avoid generating hightensions in any point of the structure do to cyclic pressure and temperature variations The jacket isdesigned to achieve uniform distribution of steam and enables the stabilization of temperature aroundthe chamber thereby giving excellent performance during the drying process and reducing the timerequired to bring the chamber up to sterilization temperatures This provides superior temperaturedistribution and prevents the formation of condensation on the chamber walls

The pressure vessel is constructed in accordance with Directive PD 5500 Directive 9723CE e ASMESection VIII Division 1 for unfired pressure vessels

123 Doors

Door(s) are constructed of AISI 316L stainless steel and reinforced mechanically rectified by a CNCprecision-machine which provides uniform quality of inner surface and precise mechanical dimensions

Door(s) are insulated with Rockwool fiber insulation and covered with a finish stainless steel panel

The steam sterilizer is equipped with one or two hinged vertical or horizontal sliding doors accordingto your model

Hinged doors for AJC 50x50 biosafety P3 type laboratory sterilizers can be either left side or right sidehinged Doors are operated with low effort manual lockunlock rotating mechanism and have a speciallock security device When open door(s) angle overture is higher than 90ordm put them totally out of thechamber space allowing safe and complete access to them and to the load

Vertical or horizontal sliding door(s)

Respectively for AJC 70x70 and AJC 70x112 sterilizers have automatic operation and each door isoperated by one pneumatic cylinder mounted at the central inner part of the door The operation of thecylinder is performed by air pressure and acts as a speed and motion control system An adjustablerestrictor controls the flow of compressed air controlling the speed movement of the door Door motionis controlled from the touch screen display Horizontal door models are available with doors that slidefrom left-to-right or right-to-left

AJC 50x50 sterilizers are vertical sliding mechanically powered by an electrical motor maintenance free

with proper device for manual operation in case of electrical power failure When open door(s) are totallyout of the chamber and sealing gasket(s) allowing safe and complete access to them

8162019 Specifications Amaro 5000 amp Steri 21 MD009_04 en a J COSTA (IRMAtildeOS) LDA Desde 1953 Ao Serviccedilo Meacutedico-Hhellip

httpslidepdfcomreaderfullspecifications-amaro-5000-steri-21-md00904-en-a-j-costa-irmaos-lda 410

983117983108983088983088983097983087983088983092 983109983118

A J COSTA (IRMAtildeOS) LDA ndash Desde 1953 ao Serviccedilo Meacutedico-Hospitalar

Estrada das Ligeiras Lote 10 Alto da Bela Vista 2735-337 Caceacutem Portugal E-mail infoajcostairmaoscom URLwwwajcostairmaoscom

Geral Tel (+351) 214 266 500 Fax (+351) 214 262 421 Dep Com [Eliwell Jumo Wika] Tel (+351) 214 266 502 Fax (+351) 214 266 507

Assistecircncia Teacutecnica Tel (+351) 214 266 505 Dep Com Bombas [SIHI Busch] Tel (+351) 214 266 508 Fax (+351) 214 266 506

4

Door(s) are equipped with a sensor safety guard system which automatically stops and reverses thedoor(s) motion if any obstruction is detected along the entire path of travel

The end frame(s) of the chamber are constructed of solid AISI 316L stainless steel and entirely weldedon the pressure vessel The complete pressure vessel is then mechanically rectified and all mechanicaldimensions are controlled by a CNC precision-machine On the chamber end frame the gasket ring slot

is open calibrated and polished by the CNC conferring superior work surface for the recessed silicongasket

The silicon gasket seals the door(s) operated by steam and will maintain a secure seal even in the eventof a total utility loss The gasket is retracted under vacuum when the sterilize cycle is complete

The gaskets are easy to replace and does not require special tools or lubrication

Double door configurations are supplied with controls and security systems at both ends of the sterilizerto prevent the possibility of cross-contamination As a single door steam sterilizer equipment can bemounted as a freestanding unit with covering panel frame (OPTIONAL) or recessed on wall

The single door steam sterilizer will produce loads from and to the same area Provisions must betaken to have clear identified circuits for load the goods to sterilize and unload sterile materials for

storage and distribution

Double door steam sterilizer is mounted through a recessed wall The two doors are located in twoseparate rooms

The front load door on the side of the master control panel is facing the preparation area of thesterilization department from where the steam sterilizer is operated and serves for loading thematerial into the sterilization chamber This area is known as the ldquonon-sterile side

The other door is located on the sterile side and serves for unloading the sterilized material fromthe steam sterilizer chamber The sterile side of the steam sterilizer is equipped with a secondarycontrol panel (slave)

The silicon gasket seals the door(s) operated by steam and will maintain a secure seal even in the

event of a total utility loss The gasket is retracted under vacuum when the sterilize cycle is complete

The gaskets are easy to replace and does not require special tools or lubrication

When open door(s) are totally out of the chamber and sealing gasket(s) allowing safe and completeaccess to them

Door(s) are equipped with a sensor safety guard system which automatically stops and reverses thedoor(s) motion if any obstruction is detected along the entire path of travel

The door(s) are designed to prevent opening while under pressure or in case of electrical power failureby a safety lock mechanism with proper device for manual operation in case of power failure

Door(s) motion and operation have special interlock systems and are based on the following conditions

A cycle cannot be started if the door(s) are not properly closed and lock control system is safelyactuated

A door cannot be opened while the automatic cycle operation of the steam sterilizer is inprogress

A door cannot be opened if the chamber is under pressure

Both doors cannot be opened at the same time Opening of one door automatically locks theother

After opening the door on the unsterile side even after closing it and it being locked and sealedthe door on the clean side can be opened only after performing a complete sterilization cycle

If a cycle failed only the non-sterile side door can be opened and operated After a test cycle only the non-sterile side door can be opened and operated

8162019 Specifications Amaro 5000 amp Steri 21 MD009_04 en a J COSTA (IRMAtildeOS) LDA Desde 1953 Ao Serviccedilo Meacutedico-Hhellip

httpslidepdfcomreaderfullspecifications-amaro-5000-steri-21-md00904-en-a-j-costa-irmaos-lda 510

983117983108983088983088983097983087983088983092 983109983118

A J COSTA (IRMAtildeOS) LDA ndash Desde 1953 ao Serviccedilo Meacutedico-Hospitalar

Estrada das Ligeiras Lote 10 Alto da Bela Vista 2735-337 Caceacutem Portugal E-mail infoajcostairmaoscom URLwwwajcostairmaoscom

Geral Tel (+351) 214 266 500 Fax (+351) 214 262 421 Dep Com [Eliwell Jumo Wika] Tel (+351) 214 266 502 Fax (+351) 214 266 507

Assistecircncia Teacutecnica Tel (+351) 214 266 505 Dep Com Bombas [SIHI Busch] Tel (+351) 214 266 508 Fax (+351) 214 266 506

5

A door cannot be opened at the end of the cycle if the chamber temperature is higher than thepreset final temperature

Double door configurations are supplied with controls and security systems at both ends of the sterilizerto prevent the possibility of cross-contamination

124 Insulation

Superior heat loss reduction to the surrounding environment and heat conservation is achieved withrigid Rockwool fiber insulation overlaid with AISI 304L stainless steel sheet-metal The sheet-metal isformed overlapped and riveted along the pressure vessel The stainless steel sheet makes theinsulation system impervious to water thus eliminating wet condensation

125 Piping

All piping components delivering steam or sterile air to the load are stainless steel threaded and brasscomponents All piping connections terminate within the confines of the sterilizer and are accessible as

standard from front and right side of sterilizer

All major piping pneumatic and electrical components are tagged and numbered to match thediagrams Threaded stainless steel is available as a customer option

Steam traps are thermostatic non-proprietary and NTS (nearly to steam) industrial grade They arepositioned and sized for maximum efficiency Steam traps are used for the removal of air andcondensate from the system

Control valves are non-proprietary industrial grade brass or stainless steel They are actuated byelectric solenoids for air pressure 24V DC Pneumatic valves for steam exhaust and sterile air havespecial connectors to simplify sterilizer piping and can be serviced individually Water control valvesare 24V DC operated Safety valves are approved stamped and sized for the vessel design pressure

126 Vacuum System

Rapid evacuation of chamber air and moisture is achieved with a liquid ring vacuum pump Thevacuum pump reduces the chamber pressure during pre-vacuum and post-drying phases

A water conservation system is used to limit the consumption of the potable water during the processand to guarantee maximum efficiency of the vacuum pump

The liquid ring vacuum pump works in a self-recirculated circuit reducing water consumption Effluentdischarge temperature is further reduced by a dual pass coil bundle heat exchanger before enteringthe vacuum pump The discharge temperature is further reduced by cool water at the floor drain

Cooling water flow is regulated by the waste line temperature controller to minimize water usage Thesystem is designed to work with cold water up to 15ordm C

Following the drying phase chamber vacuum is relieved to atmospheric pressure by an air inletbacteria-retentive filter With an absolute rated membrane efficiently remove all particles down to 001micron thus removing airborne bacteria viruses and bacteriophage It is easy accessible

127 Steam Source

The steam source requires clean house steam and the sterilizers are piped valved and trapped toreceive building supplied steam

Steam must be supplied with particulates removed and be suitably line trapped to ensure that it is dryand supplied at 30 to 35 bar dynamic

8162019 Specifications Amaro 5000 amp Steri 21 MD009_04 en a J COSTA (IRMAtildeOS) LDA Desde 1953 Ao Serviccedilo Meacutedico-Hhellip

httpslidepdfcomreaderfullspecifications-amaro-5000-steri-21-md00904-en-a-j-costa-irmaos-lda 610

983117983108983088983088983097983087983088983092 983109983118

A J COSTA (IRMAtildeOS) LDA ndash Desde 1953 ao Serviccedilo Meacutedico-Hospitalar

Estrada das Ligeiras Lote 10 Alto da Bela Vista 2735-337 Caceacutem Portugal E-mail infoajcostairmaoscom URLwwwajcostairmaoscom

Geral Tel (+351) 214 266 500 Fax (+351) 214 262 421 Dep Com [Eliwell Jumo Wika] Tel (+351) 214 266 502 Fax (+351) 214 266 507

Assistecircncia Teacutecnica Tel (+351) 214 266 505 Dep Com Bombas [SIHI Busch] Tel (+351) 214 266 508 Fax (+351) 214 266 506

6

Standard sterilizer steam piping is constructed of stainless steel and includes a shutoff valve and asteam trap

As buyerrsquos option the steam sterilizer can be equipped with an electrical heated built-in stainless steelAISI 304L steam generator

Depending on the option the built-in steam generator can act as a standby unit if building steam is notavailable for the sterilization process or can be the main source of saturated steam for the sterilizationprocess

If the steam sterilizer have a DUAL OPTION for steam source the steam sterilizer is built to receivetwo steam supply sources namely from the building or from the internal built-in steam generator Thereis a selector function on the user interface to choose the steam source Before selecting the built-ingenerator as steam source check if the steam generator is connected to the electrical supply and it isworking properly

Internal built-in steam generator main features are

bull Water level control system ndash Consists of three capacitive level sensors mounted on anexternal water level sight pipe heat and pressure resistant that allows constant observation of

water level while the steam generator is in operation Water level sensors are not influenced bywater resistivity ensuring work capability with low water conductivity as reverse osmosis waterquality Water level is automatically controlled maintaining the proper working level and shuts ofthe heating elements when water supply drops below a safe operating level

bull Heating elements ndash Long life heavy duty stainless steel AISI 316 heating elements welded onan AISI 316 stainless steel flange for added strength and safety

bull Water pressurizing pump ndash The water pump supplies distilled or mineral-free water to thesteam generator The water pump ensures that water inlet pressure to the steam generator isnot dependent of the facility water inlet pressure

bull Operating pressure control ndash Operates automatically to maintain steam pressure at working

defined range

bull Steam pressure safety valve ndash Certified pressure relief valve that automatically opens toreduce pressure should excessive steam cause pressure build-up

bull Blow downdrain valve ndash Facilitates emptying the steam generator during blow downdrainsequence Automatic blow down as OPTION

bull Steam pressure gauge ndash Positioned at service area allows visual observation of steampressure over full range

128 Control System

The gauges touchpad and printer are mounted in the stainless fascia panel

The electronic control system and software monitors and controls all sterilizer operations and functionsand are designed to operate up to 16 different factory-programed standard sterilization and testprograms

The control system of the sterilizer is based on microcomputer technology ensuring a highly reliableand safe operation The computerized control unit ensures a fully automatic operation through theentire process hence after setting the pre-selected parameters and starting the operation no furtheroperator intervention is necessary

Factory pre-set programs are intended for instruments in containers single or double wrappedinstruments and packs wrapped fabrics heat and moisture sensitive materials prions cycle slow

exhaust pressure cycles for sterilizing liquids in borosilicate containers with vented closures and warm-up cycle In addition there are two test programs Bowie amp Dick Test and the Vacuum Leak Test

8162019 Specifications Amaro 5000 amp Steri 21 MD009_04 en a J COSTA (IRMAtildeOS) LDA Desde 1953 Ao Serviccedilo Meacutedico-Hhellip

httpslidepdfcomreaderfullspecifications-amaro-5000-steri-21-md00904-en-a-j-costa-irmaos-lda 710

983117983108983088983088983097983087983088983092 983109983118

A J COSTA (IRMAtildeOS) LDA ndash Desde 1953 ao Serviccedilo Meacutedico-Hospitalar

Estrada das Ligeiras Lote 10 Alto da Bela Vista 2735-337 Caceacutem Portugal E-mail infoajcostairmaoscom URLwwwajcostairmaoscom

Geral Tel (+351) 214 266 500 Fax (+351) 214 262 421 Dep Com [Eliwell Jumo Wika] Tel (+351) 214 266 502 Fax (+351) 214 266 507

Assistecircncia Teacutecnica Tel (+351) 214 266 505 Dep Com Bombas [SIHI Busch] Tel (+351) 214 266 508 Fax (+351) 214 266 506

7

Special propose sterilizers for biosafety P3 type laboratories have cycles for contaminated wastematerial in bags or special containers

Special propose sterilizers for biosafety P3 type laboratories may be provided with dual controlcapabilities allowing for pass-through sterilization of materials entering into containment areasdecontamination of used items and waste leaving that area and as single door sterilization applications

from either side of the sterilizer or only from and to the containment areaThe sterilizers AJC are equipped with laboratory work cycles standardly programmed In order to

perform the laboratory work cycles the sterilizer should also be supplied with an additional accessory

a product probe to accurately measure the temperature inside the liquid to be sterilized

The laboratory work cycles include cycles for liquids in open containers The operator is able to choose

if the process of initial evacuation is assisted by vacuum or not as well as whether it is a fast or slow

exhaustion process The laboratory work cycles also enable the selection of temperature the contact

time for sterilization and the possibility of controlling the process by F0 function

In addition to laboratory work cycles the sterilizers AJC are also programmed with test work cyclesBowie amp Dick and vacuum cycles along with sterilization cycles for glassware and wrapped or

unwrapped instruments for immediate use with drying phase assisted by vacuum

As optional the sterilizer can be equipped with sterilization work cycles specially designed for animal

cages These cycles enable the operator to program different process parameters including

temperature contact time of sterilization and drying time The process of air exhaustion is automatically

controlled and implemented through an HEPA filter sterilized by steam allowing the operator to control

efficiently the process of sterilization of contaminated materials

As optional the sterilizer can also be equipped with two sterilization work cycles for pet food diet

These cycles allow the operator to program different process parameters including the temperaturecontact time for sterilization selection of initial air removal stage and final stage of drying by vacuum

assisted It is also possible to set the drying time vacuum control and the possibility of drying control

assisted by residual humidity

The working cycles are completely customizable according to customer needs since it is possible toprogram 18 different sterilization cycles

A list of real-time process critical values the selected program the main phases of the cycletemperature pressure and the status of the machine are controlled and displayed on a color touchscreen digital display with graphical display (Plot Graph) For process documentation all the relevantinformation concerning operation is printed

The touch screen allows the user to operate and program the steam sterilizer control by touching(pressing) the appropriate touch-sensitive areas on the display On each screen all rectangular-outlined boxes are touch-sensitive areas referred to as buttons

The color touch screen display and keyboards located on both the non-sterile and sterile panelsenables including but not limited to the operator to select a sterilization program startstop a cycleand close or open a door

A programming mode which can be accessed by a code from the unsterile panel display only enablestechnicians to set up the system set and change a number of additional parameters and operationalmodes and perform calibration

As default the user has access to cycle selection cycle start and door control Users can only runfactory-set cycles and test cycles Access to other functions such as setting parameters calibration

8162019 Specifications Amaro 5000 amp Steri 21 MD009_04 en a J COSTA (IRMAtildeOS) LDA Desde 1953 Ao Serviccedilo Meacutedico-Hhellip

httpslidepdfcomreaderfullspecifications-amaro-5000-steri-21-md00904-en-a-j-costa-irmaos-lda 810

983117983108983088983088983097983087983088983092 983109983118

A J COSTA (IRMAtildeOS) LDA ndash Desde 1953 ao Serviccedilo Meacutedico-Hospitalar

Estrada das Ligeiras Lote 10 Alto da Bela Vista 2735-337 Caceacutem Portugal E-mail infoajcostairmaoscom URLwwwajcostairmaoscom

Geral Tel (+351) 214 266 500 Fax (+351) 214 262 421 Dep Com [Eliwell Jumo Wika] Tel (+351) 214 266 502 Fax (+351) 214 266 507

Assistecircncia Teacutecnica Tel (+351) 214 266 505 Dep Com Bombas [SIHI Busch] Tel (+351) 214 266 508 Fax (+351) 214 266 506

8

service and maintenance procedures is controlled using pre-defined access levels and passwordspreventing unauthorized access

Each cycle is adjustable to meet specific processing requirements All user-accessible control functionscan be changed using the touch screen control Cycle parameters are retained in control memory forrepeated use Once cycle is started cycles and cycle values cannot be changed until cycle is

complete The system features a comprehensive alarmalert system with automatic triggering of pre-programmable information alerts The self-diagnostic program monitors the sterilizer performanceautomatically and process check-up and failure corrections

In case of a malfunction during the sterilization cycle the process enters in an emergency alarm phasewhich safely will end the process automatically

Alarm range includes

bull Temperature pressure sensor and analogue input failure

bull Power failure

bull Door(s) failure

bull Gasket and chamber sealing failure

bull Phase Timeout

bull Doors safety interlock failure

bull Water supply failure

bull Steam failure

bull Compressed air failure

bull Vacuum Pump failure

bull Microcomputer failure

The bar Graph screen displays the chamber temperature and pressure as a bar graph and also showsa digital time representing the time remaining in the cycle The Plot Graph screen displays the chambertemperature and pressure as a trend curve using a graphic display

A process data record printer and a graphic recorder (as OPTIONAL) are mounted at the non -sterileside to record all relevant process information like program cycle steps time temperature pressuredate cycle start time both sterilizer and daily cycle number total cycle count fault conditions userverification and signature and load information

Data is automatically printed at the beginning and at the end of each cycle with all transition pointrsquosinformation and summary verification of time at selected temperaturepressure (minmax values)performed during cycle operation

The microcomputer stores the cycle data and in case of printer failure during the cycle or on demandthe user can reprint the last cycle

As buyerrsquos option the steam sterilizer can be equipped with a load temperature probe inside thesterilization chamber and perform sterilization based F0 control The control system allows control ofliquid sterilization by F0 value rather than time and temperature This mode of control may optionally beused for heat sensitive liquids

Before operating the sterilizer it is important to become familiar with the location and function of allmajor components and controls

As OPTIONAL the record system can be mounted on the ldquosterile siderdquo

8162019 Specifications Amaro 5000 amp Steri 21 MD009_04 en a J COSTA (IRMAtildeOS) LDA Desde 1953 Ao Serviccedilo Meacutedico-Hhellip

httpslidepdfcomreaderfullspecifications-amaro-5000-steri-21-md00904-en-a-j-costa-irmaos-lda 910

983117983108983088983088983097983087983088983092 983109983118

A J COSTA (IRMAtildeOS) LDA ndash Desde 1953 ao Serviccedilo Meacutedico-Hospitalar

Estrada das Ligeiras Lote 10 Alto da Bela Vista 2735-337 Caceacutem Portugal E-mail infoajcostairmaoscom URLwwwajcostairmaoscom

Geral Tel (+351) 214 266 500 Fax (+351) 214 262 421 Dep Com [Eliwell Jumo Wika] Tel (+351) 214 266 502 Fax (+351) 214 266 507

Assistecircncia Teacutecnica Tel (+351) 214 266 505 Dep Com Bombas [SIHI Busch] Tel (+351) 214 266 508 Fax (+351) 214 266 506

9

The steam sterilizer has an automatic shutdown system If no operation is performed after anadjustable time it will go into an energy conservation mode Sterilizer utilities can be restarted as soonthe user starts or selects a new cycle

129 Temperature and Pressure Sensors and Gauges

The system is equipped with up to four temperature sensors two absolute pressure transducers fourpressure gauges and safety devices having the following functions

The temperature sensors

In the drain ndash control of heat exchanger drain and liquid ring vacuum pump watertemperature

In the chamber condensate line (double independent PT100 probe) ndash controlmonitoring and printout of sterilization process temperature

Inside the chamber (flexible PT100 probe as OPTIONAL for liquids) ndash controlmonitoring and printout of load sterilization process temperature

The absolute pressure transducers

Chamber pressure ndash control display monitoring and printout

Jacket pressure ndash control display monitoring and printout

The pressure gauges (front panel as OPTIONAL)

Front Panel

Steam source pressure (built-in steam generator or building steam supply)

Chamber pressure

Jacket pressure

Service Area

Steam source pressure (built-in steam generator andor building steam supply)

The safety devices

Pressure Safety Valves

Built-in steam generator certified pre-set pressure calibrated for 34 bar gauge

Chamber certified pre-set pressure calibrated for 24 bar gauge

Jacket certified pre-set pressure calibrated for 26 bar gauge

Door(s) end switch

Open and close position prevents the inlet of steam pressure to the chamber andto the door gasket if the door is not closed

Door(s) safety lock

Safety lock mechanism with proper device for manual operation preventing theopening of in case of power failure preventing the door from opening in case ofelectrical power or compressed air failure

Door(s) sensor safety

Two sensors for safety guard system on each door which automatically stopsand reverses the door(s) motion if any obstruction is detected along the entire

path of travel preventing the door from trapping any object while closingEmergency Stop push-buttons

8162019 Specifications Amaro 5000 amp Steri 21 MD009_04 en a J COSTA (IRMAtildeOS) LDA Desde 1953 Ao Serviccedilo Meacutedico-Hhellip

httpslidepdfcomreaderfullspecifications-amaro-5000-steri-21-md00904-en-a-j-costa-irmaos-lda 1010

983117983108983088983088983097983087983088983092 983109983118

A J COSTA (IRMAtildeOS) LDA ndash Desde 1953 ao Serviccedilo Meacutedico-Hospitalar

Estrada das Ligeiras Lote 10 Alto da Bela Vista 2735-337 Caceacutem Portugal E-mail infoajcostairmaoscom URLwwwajcostairmaoscom

Geral Tel (+351) 214 266 500 Fax (+351) 214 262 421 Dep Com [Eliwell Jumo Wika] Tel (+351) 214 266 502 Fax (+351) 214 266 507

10

Mounted on both the unsterile and sterile panel This feature is designed toprevent human hazards accidents or equipment breakdown in compliance withthe European Standards EN-285 requirements

13 Standards

A J Costa (Irmatildeos) Lda meets the provisions of the Medical Device Directive 9342EEC and PED9723EEC and the following standards

EN 2852006 - Sterilization - Steam sterilizers - Large sterilizers

ISO 17665-12006 ndash Sterilization of health care products - Moist heat - Part 1 Requirements forthe development validation and routine control of a sterilization process for medical devices

ASME Section VIII Division I for unfired pressure vessels - ASME Boiler and pressurevessel code

IEC 61010-2-0402005 ndash Safety requirements for electrical equipment for measurement controland laboratory use ndash Part 2 ndash 040 Particular requirements for sterilizers and washer-disinfectorsused to treat medical materials

IEC 61326-12005 ndash Electrical equipment for measurement control and laboratory use ndash EMCrequirements ndash Part 1 General requirements

A J Costa (Irmatildeos) Lda is also approved for

ISO 9001 (Quality Management Systems)

ISO 13485 (Medical devices mdash Quality management systems ndash Requirements for regulatorypurposes )

Page 2: Specifications. Amaro 5000 & Steri 21 MD009_04 en. a. J. COSTA (IRMÃOS), LDA. Desde 1953 Ao Serviço Médico-Hospitalar

8162019 Specifications Amaro 5000 amp Steri 21 MD009_04 en a J COSTA (IRMAtildeOS) LDA Desde 1953 Ao Serviccedilo Meacutedico-Hhellip

httpslidepdfcomreaderfullspecifications-amaro-5000-steri-21-md00904-en-a-j-costa-irmaos-lda 210

983117983108983088983088983097983087983088983092 983109983118

A J COSTA (IRMAtildeOS) LDA ndash Desde 1953 ao Serviccedilo Meacutedico-Hospitalar

Estrada das Ligeiras Lote 10 Alto da Bela Vista 2735-337 Caceacutem Portugal E-mail infoajcostairmaoscom URLwwwajcostairmaoscom

Geral Tel (+351) 214 266 500 Fax (+351) 214 262 421 Dep Com [Eliwell Jumo Wika] Tel (+351) 214 266 502 Fax (+351) 214 266 507

Assistecircncia Teacutecnica Tel (+351) 214 266 505 Dep Com Bombas [SIHI Busch] Tel (+351) 214 266 508 Fax (+351) 214 266 506

2

1 GENERAL INFORMATION

11 Technical Introduction

A J Costa (Irmatildeos) Lda steam sterilizers are designed to cover a large field of applications for

hospitals and medical centers as well as pharmaceutical and biotechnological industries and researchlaboratories They meet the latest features in state-of-the-art sterilization technology

A J Costa (Irmatildeos) Lda sterilizers are available as multi-functional steam sterilizer with pre-vacuumand post-vacuum technology for healthcare facilities applications and gravity capabilities as laboratoryliquids steam sterilizer

All sterilizers are available for installation either recessed through wall or as freestanding models Asbuyerrsquos option freestanding sterilizers are cabinet mounted with stainless steel cover panels

A J Costa (Irmatildeos) Lda 50x50(cm) cross-section sterilizers for special application biosafety P3 typelaboratories have manual hinged doors AJC 50x50(cm) amp 70x70(cm) cross-section sterilizers haveautomatic vertical sliding power doors Larger units AJC 70x112(cm) cross-section sterilizers are

equipped with power automatic horizontal sliding doorsA J Costa (Irmatildeos) Lda sterilizers feature a microcomputer control system with a color touch screendisplay interface and a digital printer The microcomputer controls the steam sterilizers with a pulsingpressurevacuum air removal system Visual indicators monitor all cycle phases with audible andvisual cycle completion indicators It is designed for efficient sterilization of heat- and moisture-stablewrapped or unwrapped instruments and materials textiles heat sensitive materials instruments incontainers dry goods laboratory glassware flask liquids and laboratory contaminated waste goods

Pre-vacuum configuration sterilizers are equipped with pre vacuum gravity liquid leak test and dailyair removal (Bowie-Dick) test cycles

12 Construction Specifications

121 Frame

The sterilizer pressure vessel and components are secured to a welded structural frame The frame isconstructed in stainless steel It is mounted on threaded leveling screws with supplemental stainlesssteel weight distribution footpads The frame is mechanically rectified by a CNC precision-machine forperfect alignment of all mounted devices

122 Sterilizer Pressure Vessel

The steam sterilizer is prepared to operate with saturated steam as sterilizing agent condensatefree 97 to 100 vapor quality and working at a temperature range from 105ordm C of up to 137ordm C andpressure up to 330 kPa

The pressure vessel is a shell parallelepiped shape composed by the sterilization chamber and a fullintegral surrounding jacket

1221 Chamber

The chamber is made of AISI 316L stainless steel with an internal high finish luster obtained bymechanical polishing It is constructed with 2 sheet-metal U-shaped Chamber is of entirely weldedconstruction with interior longitudinal corners that are radiused The chamber is fully jacketed Steambaffles are positioned in the chamber to minimize wetting by condensate and insure proper steam

distribution and equal load surface heating The chamber drain system is on the center of the

8162019 Specifications Amaro 5000 amp Steri 21 MD009_04 en a J COSTA (IRMAtildeOS) LDA Desde 1953 Ao Serviccedilo Meacutedico-Hhellip

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983117983108983088983088983097983087983088983092 983109983118

A J COSTA (IRMAtildeOS) LDA ndash Desde 1953 ao Serviccedilo Meacutedico-Hospitalar

Estrada das Ligeiras Lote 10 Alto da Bela Vista 2735-337 Caceacutem Portugal E-mail infoajcostairmaoscom URLwwwajcostairmaoscom

Geral Tel (+351) 214 266 500 Fax (+351) 214 262 421 Dep Com [Eliwell Jumo Wika] Tel (+351) 214 266 502 Fax (+351) 214 266 507

Assistecircncia Teacutecnica Tel (+351) 214 266 505 Dep Com Bombas [SIHI Busch] Tel (+351) 214 266 508 Fax (+351) 214 266 506

3

chamber designed to disposes condensate to waste and equipped with safety systems to preventsterilizer effluent from entering the sterilization chamber

An automatic steam condenser exhaust system reduces temperature of exhaust steam flowing to thedrain

The automatic condensing system consisting of a stainless steel heat exchanger converts chambersteam to condensate and disposes condensate to waste Cooling water flow is regulated by the wasteline temperature control system to minimize water usage

On double door units the end frame bulkhead of the chamber are constructed of solid AISI 316Lstainless steel and entirely welded on the pressure vessel

On single door units back of chamber is fitted with welded 316L stainless-steel head

The complete pressure vessel is then mechanically rectified and all mechanical dimensions arecontrolled by a CNC precision-machine

1222 Jacket

The jacket is constructed of AISI 304L stainless steel It is constructed with 2 sheet-metal U-shapedparts Directly on those 2 sheet-metal strength points are mechanical shaped and the jacket is ofentirely welded mounted and welded to the chamber giving reinforcement according to the cross-section of the chamber The jacket along with the chamber is designed to avoid generating hightensions in any point of the structure do to cyclic pressure and temperature variations The jacket isdesigned to achieve uniform distribution of steam and enables the stabilization of temperature aroundthe chamber thereby giving excellent performance during the drying process and reducing the timerequired to bring the chamber up to sterilization temperatures This provides superior temperaturedistribution and prevents the formation of condensation on the chamber walls

The pressure vessel is constructed in accordance with Directive PD 5500 Directive 9723CE e ASMESection VIII Division 1 for unfired pressure vessels

123 Doors

Door(s) are constructed of AISI 316L stainless steel and reinforced mechanically rectified by a CNCprecision-machine which provides uniform quality of inner surface and precise mechanical dimensions

Door(s) are insulated with Rockwool fiber insulation and covered with a finish stainless steel panel

The steam sterilizer is equipped with one or two hinged vertical or horizontal sliding doors accordingto your model

Hinged doors for AJC 50x50 biosafety P3 type laboratory sterilizers can be either left side or right sidehinged Doors are operated with low effort manual lockunlock rotating mechanism and have a speciallock security device When open door(s) angle overture is higher than 90ordm put them totally out of thechamber space allowing safe and complete access to them and to the load

Vertical or horizontal sliding door(s)

Respectively for AJC 70x70 and AJC 70x112 sterilizers have automatic operation and each door isoperated by one pneumatic cylinder mounted at the central inner part of the door The operation of thecylinder is performed by air pressure and acts as a speed and motion control system An adjustablerestrictor controls the flow of compressed air controlling the speed movement of the door Door motionis controlled from the touch screen display Horizontal door models are available with doors that slidefrom left-to-right or right-to-left

AJC 50x50 sterilizers are vertical sliding mechanically powered by an electrical motor maintenance free

with proper device for manual operation in case of electrical power failure When open door(s) are totallyout of the chamber and sealing gasket(s) allowing safe and complete access to them

8162019 Specifications Amaro 5000 amp Steri 21 MD009_04 en a J COSTA (IRMAtildeOS) LDA Desde 1953 Ao Serviccedilo Meacutedico-Hhellip

httpslidepdfcomreaderfullspecifications-amaro-5000-steri-21-md00904-en-a-j-costa-irmaos-lda 410

983117983108983088983088983097983087983088983092 983109983118

A J COSTA (IRMAtildeOS) LDA ndash Desde 1953 ao Serviccedilo Meacutedico-Hospitalar

Estrada das Ligeiras Lote 10 Alto da Bela Vista 2735-337 Caceacutem Portugal E-mail infoajcostairmaoscom URLwwwajcostairmaoscom

Geral Tel (+351) 214 266 500 Fax (+351) 214 262 421 Dep Com [Eliwell Jumo Wika] Tel (+351) 214 266 502 Fax (+351) 214 266 507

Assistecircncia Teacutecnica Tel (+351) 214 266 505 Dep Com Bombas [SIHI Busch] Tel (+351) 214 266 508 Fax (+351) 214 266 506

4

Door(s) are equipped with a sensor safety guard system which automatically stops and reverses thedoor(s) motion if any obstruction is detected along the entire path of travel

The end frame(s) of the chamber are constructed of solid AISI 316L stainless steel and entirely weldedon the pressure vessel The complete pressure vessel is then mechanically rectified and all mechanicaldimensions are controlled by a CNC precision-machine On the chamber end frame the gasket ring slot

is open calibrated and polished by the CNC conferring superior work surface for the recessed silicongasket

The silicon gasket seals the door(s) operated by steam and will maintain a secure seal even in the eventof a total utility loss The gasket is retracted under vacuum when the sterilize cycle is complete

The gaskets are easy to replace and does not require special tools or lubrication

Double door configurations are supplied with controls and security systems at both ends of the sterilizerto prevent the possibility of cross-contamination As a single door steam sterilizer equipment can bemounted as a freestanding unit with covering panel frame (OPTIONAL) or recessed on wall

The single door steam sterilizer will produce loads from and to the same area Provisions must betaken to have clear identified circuits for load the goods to sterilize and unload sterile materials for

storage and distribution

Double door steam sterilizer is mounted through a recessed wall The two doors are located in twoseparate rooms

The front load door on the side of the master control panel is facing the preparation area of thesterilization department from where the steam sterilizer is operated and serves for loading thematerial into the sterilization chamber This area is known as the ldquonon-sterile side

The other door is located on the sterile side and serves for unloading the sterilized material fromthe steam sterilizer chamber The sterile side of the steam sterilizer is equipped with a secondarycontrol panel (slave)

The silicon gasket seals the door(s) operated by steam and will maintain a secure seal even in the

event of a total utility loss The gasket is retracted under vacuum when the sterilize cycle is complete

The gaskets are easy to replace and does not require special tools or lubrication

When open door(s) are totally out of the chamber and sealing gasket(s) allowing safe and completeaccess to them

Door(s) are equipped with a sensor safety guard system which automatically stops and reverses thedoor(s) motion if any obstruction is detected along the entire path of travel

The door(s) are designed to prevent opening while under pressure or in case of electrical power failureby a safety lock mechanism with proper device for manual operation in case of power failure

Door(s) motion and operation have special interlock systems and are based on the following conditions

A cycle cannot be started if the door(s) are not properly closed and lock control system is safelyactuated

A door cannot be opened while the automatic cycle operation of the steam sterilizer is inprogress

A door cannot be opened if the chamber is under pressure

Both doors cannot be opened at the same time Opening of one door automatically locks theother

After opening the door on the unsterile side even after closing it and it being locked and sealedthe door on the clean side can be opened only after performing a complete sterilization cycle

If a cycle failed only the non-sterile side door can be opened and operated After a test cycle only the non-sterile side door can be opened and operated

8162019 Specifications Amaro 5000 amp Steri 21 MD009_04 en a J COSTA (IRMAtildeOS) LDA Desde 1953 Ao Serviccedilo Meacutedico-Hhellip

httpslidepdfcomreaderfullspecifications-amaro-5000-steri-21-md00904-en-a-j-costa-irmaos-lda 510

983117983108983088983088983097983087983088983092 983109983118

A J COSTA (IRMAtildeOS) LDA ndash Desde 1953 ao Serviccedilo Meacutedico-Hospitalar

Estrada das Ligeiras Lote 10 Alto da Bela Vista 2735-337 Caceacutem Portugal E-mail infoajcostairmaoscom URLwwwajcostairmaoscom

Geral Tel (+351) 214 266 500 Fax (+351) 214 262 421 Dep Com [Eliwell Jumo Wika] Tel (+351) 214 266 502 Fax (+351) 214 266 507

Assistecircncia Teacutecnica Tel (+351) 214 266 505 Dep Com Bombas [SIHI Busch] Tel (+351) 214 266 508 Fax (+351) 214 266 506

5

A door cannot be opened at the end of the cycle if the chamber temperature is higher than thepreset final temperature

Double door configurations are supplied with controls and security systems at both ends of the sterilizerto prevent the possibility of cross-contamination

124 Insulation

Superior heat loss reduction to the surrounding environment and heat conservation is achieved withrigid Rockwool fiber insulation overlaid with AISI 304L stainless steel sheet-metal The sheet-metal isformed overlapped and riveted along the pressure vessel The stainless steel sheet makes theinsulation system impervious to water thus eliminating wet condensation

125 Piping

All piping components delivering steam or sterile air to the load are stainless steel threaded and brasscomponents All piping connections terminate within the confines of the sterilizer and are accessible as

standard from front and right side of sterilizer

All major piping pneumatic and electrical components are tagged and numbered to match thediagrams Threaded stainless steel is available as a customer option

Steam traps are thermostatic non-proprietary and NTS (nearly to steam) industrial grade They arepositioned and sized for maximum efficiency Steam traps are used for the removal of air andcondensate from the system

Control valves are non-proprietary industrial grade brass or stainless steel They are actuated byelectric solenoids for air pressure 24V DC Pneumatic valves for steam exhaust and sterile air havespecial connectors to simplify sterilizer piping and can be serviced individually Water control valvesare 24V DC operated Safety valves are approved stamped and sized for the vessel design pressure

126 Vacuum System

Rapid evacuation of chamber air and moisture is achieved with a liquid ring vacuum pump Thevacuum pump reduces the chamber pressure during pre-vacuum and post-drying phases

A water conservation system is used to limit the consumption of the potable water during the processand to guarantee maximum efficiency of the vacuum pump

The liquid ring vacuum pump works in a self-recirculated circuit reducing water consumption Effluentdischarge temperature is further reduced by a dual pass coil bundle heat exchanger before enteringthe vacuum pump The discharge temperature is further reduced by cool water at the floor drain

Cooling water flow is regulated by the waste line temperature controller to minimize water usage Thesystem is designed to work with cold water up to 15ordm C

Following the drying phase chamber vacuum is relieved to atmospheric pressure by an air inletbacteria-retentive filter With an absolute rated membrane efficiently remove all particles down to 001micron thus removing airborne bacteria viruses and bacteriophage It is easy accessible

127 Steam Source

The steam source requires clean house steam and the sterilizers are piped valved and trapped toreceive building supplied steam

Steam must be supplied with particulates removed and be suitably line trapped to ensure that it is dryand supplied at 30 to 35 bar dynamic

8162019 Specifications Amaro 5000 amp Steri 21 MD009_04 en a J COSTA (IRMAtildeOS) LDA Desde 1953 Ao Serviccedilo Meacutedico-Hhellip

httpslidepdfcomreaderfullspecifications-amaro-5000-steri-21-md00904-en-a-j-costa-irmaos-lda 610

983117983108983088983088983097983087983088983092 983109983118

A J COSTA (IRMAtildeOS) LDA ndash Desde 1953 ao Serviccedilo Meacutedico-Hospitalar

Estrada das Ligeiras Lote 10 Alto da Bela Vista 2735-337 Caceacutem Portugal E-mail infoajcostairmaoscom URLwwwajcostairmaoscom

Geral Tel (+351) 214 266 500 Fax (+351) 214 262 421 Dep Com [Eliwell Jumo Wika] Tel (+351) 214 266 502 Fax (+351) 214 266 507

Assistecircncia Teacutecnica Tel (+351) 214 266 505 Dep Com Bombas [SIHI Busch] Tel (+351) 214 266 508 Fax (+351) 214 266 506

6

Standard sterilizer steam piping is constructed of stainless steel and includes a shutoff valve and asteam trap

As buyerrsquos option the steam sterilizer can be equipped with an electrical heated built-in stainless steelAISI 304L steam generator

Depending on the option the built-in steam generator can act as a standby unit if building steam is notavailable for the sterilization process or can be the main source of saturated steam for the sterilizationprocess

If the steam sterilizer have a DUAL OPTION for steam source the steam sterilizer is built to receivetwo steam supply sources namely from the building or from the internal built-in steam generator Thereis a selector function on the user interface to choose the steam source Before selecting the built-ingenerator as steam source check if the steam generator is connected to the electrical supply and it isworking properly

Internal built-in steam generator main features are

bull Water level control system ndash Consists of three capacitive level sensors mounted on anexternal water level sight pipe heat and pressure resistant that allows constant observation of

water level while the steam generator is in operation Water level sensors are not influenced bywater resistivity ensuring work capability with low water conductivity as reverse osmosis waterquality Water level is automatically controlled maintaining the proper working level and shuts ofthe heating elements when water supply drops below a safe operating level

bull Heating elements ndash Long life heavy duty stainless steel AISI 316 heating elements welded onan AISI 316 stainless steel flange for added strength and safety

bull Water pressurizing pump ndash The water pump supplies distilled or mineral-free water to thesteam generator The water pump ensures that water inlet pressure to the steam generator isnot dependent of the facility water inlet pressure

bull Operating pressure control ndash Operates automatically to maintain steam pressure at working

defined range

bull Steam pressure safety valve ndash Certified pressure relief valve that automatically opens toreduce pressure should excessive steam cause pressure build-up

bull Blow downdrain valve ndash Facilitates emptying the steam generator during blow downdrainsequence Automatic blow down as OPTION

bull Steam pressure gauge ndash Positioned at service area allows visual observation of steampressure over full range

128 Control System

The gauges touchpad and printer are mounted in the stainless fascia panel

The electronic control system and software monitors and controls all sterilizer operations and functionsand are designed to operate up to 16 different factory-programed standard sterilization and testprograms

The control system of the sterilizer is based on microcomputer technology ensuring a highly reliableand safe operation The computerized control unit ensures a fully automatic operation through theentire process hence after setting the pre-selected parameters and starting the operation no furtheroperator intervention is necessary

Factory pre-set programs are intended for instruments in containers single or double wrappedinstruments and packs wrapped fabrics heat and moisture sensitive materials prions cycle slow

exhaust pressure cycles for sterilizing liquids in borosilicate containers with vented closures and warm-up cycle In addition there are two test programs Bowie amp Dick Test and the Vacuum Leak Test

8162019 Specifications Amaro 5000 amp Steri 21 MD009_04 en a J COSTA (IRMAtildeOS) LDA Desde 1953 Ao Serviccedilo Meacutedico-Hhellip

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983117983108983088983088983097983087983088983092 983109983118

A J COSTA (IRMAtildeOS) LDA ndash Desde 1953 ao Serviccedilo Meacutedico-Hospitalar

Estrada das Ligeiras Lote 10 Alto da Bela Vista 2735-337 Caceacutem Portugal E-mail infoajcostairmaoscom URLwwwajcostairmaoscom

Geral Tel (+351) 214 266 500 Fax (+351) 214 262 421 Dep Com [Eliwell Jumo Wika] Tel (+351) 214 266 502 Fax (+351) 214 266 507

Assistecircncia Teacutecnica Tel (+351) 214 266 505 Dep Com Bombas [SIHI Busch] Tel (+351) 214 266 508 Fax (+351) 214 266 506

7

Special propose sterilizers for biosafety P3 type laboratories have cycles for contaminated wastematerial in bags or special containers

Special propose sterilizers for biosafety P3 type laboratories may be provided with dual controlcapabilities allowing for pass-through sterilization of materials entering into containment areasdecontamination of used items and waste leaving that area and as single door sterilization applications

from either side of the sterilizer or only from and to the containment areaThe sterilizers AJC are equipped with laboratory work cycles standardly programmed In order to

perform the laboratory work cycles the sterilizer should also be supplied with an additional accessory

a product probe to accurately measure the temperature inside the liquid to be sterilized

The laboratory work cycles include cycles for liquids in open containers The operator is able to choose

if the process of initial evacuation is assisted by vacuum or not as well as whether it is a fast or slow

exhaustion process The laboratory work cycles also enable the selection of temperature the contact

time for sterilization and the possibility of controlling the process by F0 function

In addition to laboratory work cycles the sterilizers AJC are also programmed with test work cyclesBowie amp Dick and vacuum cycles along with sterilization cycles for glassware and wrapped or

unwrapped instruments for immediate use with drying phase assisted by vacuum

As optional the sterilizer can be equipped with sterilization work cycles specially designed for animal

cages These cycles enable the operator to program different process parameters including

temperature contact time of sterilization and drying time The process of air exhaustion is automatically

controlled and implemented through an HEPA filter sterilized by steam allowing the operator to control

efficiently the process of sterilization of contaminated materials

As optional the sterilizer can also be equipped with two sterilization work cycles for pet food diet

These cycles allow the operator to program different process parameters including the temperaturecontact time for sterilization selection of initial air removal stage and final stage of drying by vacuum

assisted It is also possible to set the drying time vacuum control and the possibility of drying control

assisted by residual humidity

The working cycles are completely customizable according to customer needs since it is possible toprogram 18 different sterilization cycles

A list of real-time process critical values the selected program the main phases of the cycletemperature pressure and the status of the machine are controlled and displayed on a color touchscreen digital display with graphical display (Plot Graph) For process documentation all the relevantinformation concerning operation is printed

The touch screen allows the user to operate and program the steam sterilizer control by touching(pressing) the appropriate touch-sensitive areas on the display On each screen all rectangular-outlined boxes are touch-sensitive areas referred to as buttons

The color touch screen display and keyboards located on both the non-sterile and sterile panelsenables including but not limited to the operator to select a sterilization program startstop a cycleand close or open a door

A programming mode which can be accessed by a code from the unsterile panel display only enablestechnicians to set up the system set and change a number of additional parameters and operationalmodes and perform calibration

As default the user has access to cycle selection cycle start and door control Users can only runfactory-set cycles and test cycles Access to other functions such as setting parameters calibration

8162019 Specifications Amaro 5000 amp Steri 21 MD009_04 en a J COSTA (IRMAtildeOS) LDA Desde 1953 Ao Serviccedilo Meacutedico-Hhellip

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983117983108983088983088983097983087983088983092 983109983118

A J COSTA (IRMAtildeOS) LDA ndash Desde 1953 ao Serviccedilo Meacutedico-Hospitalar

Estrada das Ligeiras Lote 10 Alto da Bela Vista 2735-337 Caceacutem Portugal E-mail infoajcostairmaoscom URLwwwajcostairmaoscom

Geral Tel (+351) 214 266 500 Fax (+351) 214 262 421 Dep Com [Eliwell Jumo Wika] Tel (+351) 214 266 502 Fax (+351) 214 266 507

Assistecircncia Teacutecnica Tel (+351) 214 266 505 Dep Com Bombas [SIHI Busch] Tel (+351) 214 266 508 Fax (+351) 214 266 506

8

service and maintenance procedures is controlled using pre-defined access levels and passwordspreventing unauthorized access

Each cycle is adjustable to meet specific processing requirements All user-accessible control functionscan be changed using the touch screen control Cycle parameters are retained in control memory forrepeated use Once cycle is started cycles and cycle values cannot be changed until cycle is

complete The system features a comprehensive alarmalert system with automatic triggering of pre-programmable information alerts The self-diagnostic program monitors the sterilizer performanceautomatically and process check-up and failure corrections

In case of a malfunction during the sterilization cycle the process enters in an emergency alarm phasewhich safely will end the process automatically

Alarm range includes

bull Temperature pressure sensor and analogue input failure

bull Power failure

bull Door(s) failure

bull Gasket and chamber sealing failure

bull Phase Timeout

bull Doors safety interlock failure

bull Water supply failure

bull Steam failure

bull Compressed air failure

bull Vacuum Pump failure

bull Microcomputer failure

The bar Graph screen displays the chamber temperature and pressure as a bar graph and also showsa digital time representing the time remaining in the cycle The Plot Graph screen displays the chambertemperature and pressure as a trend curve using a graphic display

A process data record printer and a graphic recorder (as OPTIONAL) are mounted at the non -sterileside to record all relevant process information like program cycle steps time temperature pressuredate cycle start time both sterilizer and daily cycle number total cycle count fault conditions userverification and signature and load information

Data is automatically printed at the beginning and at the end of each cycle with all transition pointrsquosinformation and summary verification of time at selected temperaturepressure (minmax values)performed during cycle operation

The microcomputer stores the cycle data and in case of printer failure during the cycle or on demandthe user can reprint the last cycle

As buyerrsquos option the steam sterilizer can be equipped with a load temperature probe inside thesterilization chamber and perform sterilization based F0 control The control system allows control ofliquid sterilization by F0 value rather than time and temperature This mode of control may optionally beused for heat sensitive liquids

Before operating the sterilizer it is important to become familiar with the location and function of allmajor components and controls

As OPTIONAL the record system can be mounted on the ldquosterile siderdquo

8162019 Specifications Amaro 5000 amp Steri 21 MD009_04 en a J COSTA (IRMAtildeOS) LDA Desde 1953 Ao Serviccedilo Meacutedico-Hhellip

httpslidepdfcomreaderfullspecifications-amaro-5000-steri-21-md00904-en-a-j-costa-irmaos-lda 910

983117983108983088983088983097983087983088983092 983109983118

A J COSTA (IRMAtildeOS) LDA ndash Desde 1953 ao Serviccedilo Meacutedico-Hospitalar

Estrada das Ligeiras Lote 10 Alto da Bela Vista 2735-337 Caceacutem Portugal E-mail infoajcostairmaoscom URLwwwajcostairmaoscom

Geral Tel (+351) 214 266 500 Fax (+351) 214 262 421 Dep Com [Eliwell Jumo Wika] Tel (+351) 214 266 502 Fax (+351) 214 266 507

Assistecircncia Teacutecnica Tel (+351) 214 266 505 Dep Com Bombas [SIHI Busch] Tel (+351) 214 266 508 Fax (+351) 214 266 506

9

The steam sterilizer has an automatic shutdown system If no operation is performed after anadjustable time it will go into an energy conservation mode Sterilizer utilities can be restarted as soonthe user starts or selects a new cycle

129 Temperature and Pressure Sensors and Gauges

The system is equipped with up to four temperature sensors two absolute pressure transducers fourpressure gauges and safety devices having the following functions

The temperature sensors

In the drain ndash control of heat exchanger drain and liquid ring vacuum pump watertemperature

In the chamber condensate line (double independent PT100 probe) ndash controlmonitoring and printout of sterilization process temperature

Inside the chamber (flexible PT100 probe as OPTIONAL for liquids) ndash controlmonitoring and printout of load sterilization process temperature

The absolute pressure transducers

Chamber pressure ndash control display monitoring and printout

Jacket pressure ndash control display monitoring and printout

The pressure gauges (front panel as OPTIONAL)

Front Panel

Steam source pressure (built-in steam generator or building steam supply)

Chamber pressure

Jacket pressure

Service Area

Steam source pressure (built-in steam generator andor building steam supply)

The safety devices

Pressure Safety Valves

Built-in steam generator certified pre-set pressure calibrated for 34 bar gauge

Chamber certified pre-set pressure calibrated for 24 bar gauge

Jacket certified pre-set pressure calibrated for 26 bar gauge

Door(s) end switch

Open and close position prevents the inlet of steam pressure to the chamber andto the door gasket if the door is not closed

Door(s) safety lock

Safety lock mechanism with proper device for manual operation preventing theopening of in case of power failure preventing the door from opening in case ofelectrical power or compressed air failure

Door(s) sensor safety

Two sensors for safety guard system on each door which automatically stopsand reverses the door(s) motion if any obstruction is detected along the entire

path of travel preventing the door from trapping any object while closingEmergency Stop push-buttons

8162019 Specifications Amaro 5000 amp Steri 21 MD009_04 en a J COSTA (IRMAtildeOS) LDA Desde 1953 Ao Serviccedilo Meacutedico-Hhellip

httpslidepdfcomreaderfullspecifications-amaro-5000-steri-21-md00904-en-a-j-costa-irmaos-lda 1010

983117983108983088983088983097983087983088983092 983109983118

A J COSTA (IRMAtildeOS) LDA ndash Desde 1953 ao Serviccedilo Meacutedico-Hospitalar

Estrada das Ligeiras Lote 10 Alto da Bela Vista 2735-337 Caceacutem Portugal E-mail infoajcostairmaoscom URLwwwajcostairmaoscom

Geral Tel (+351) 214 266 500 Fax (+351) 214 262 421 Dep Com [Eliwell Jumo Wika] Tel (+351) 214 266 502 Fax (+351) 214 266 507

10

Mounted on both the unsterile and sterile panel This feature is designed toprevent human hazards accidents or equipment breakdown in compliance withthe European Standards EN-285 requirements

13 Standards

A J Costa (Irmatildeos) Lda meets the provisions of the Medical Device Directive 9342EEC and PED9723EEC and the following standards

EN 2852006 - Sterilization - Steam sterilizers - Large sterilizers

ISO 17665-12006 ndash Sterilization of health care products - Moist heat - Part 1 Requirements forthe development validation and routine control of a sterilization process for medical devices

ASME Section VIII Division I for unfired pressure vessels - ASME Boiler and pressurevessel code

IEC 61010-2-0402005 ndash Safety requirements for electrical equipment for measurement controland laboratory use ndash Part 2 ndash 040 Particular requirements for sterilizers and washer-disinfectorsused to treat medical materials

IEC 61326-12005 ndash Electrical equipment for measurement control and laboratory use ndash EMCrequirements ndash Part 1 General requirements

A J Costa (Irmatildeos) Lda is also approved for

ISO 9001 (Quality Management Systems)

ISO 13485 (Medical devices mdash Quality management systems ndash Requirements for regulatorypurposes )

Page 3: Specifications. Amaro 5000 & Steri 21 MD009_04 en. a. J. COSTA (IRMÃOS), LDA. Desde 1953 Ao Serviço Médico-Hospitalar

8162019 Specifications Amaro 5000 amp Steri 21 MD009_04 en a J COSTA (IRMAtildeOS) LDA Desde 1953 Ao Serviccedilo Meacutedico-Hhellip

httpslidepdfcomreaderfullspecifications-amaro-5000-steri-21-md00904-en-a-j-costa-irmaos-lda 310

983117983108983088983088983097983087983088983092 983109983118

A J COSTA (IRMAtildeOS) LDA ndash Desde 1953 ao Serviccedilo Meacutedico-Hospitalar

Estrada das Ligeiras Lote 10 Alto da Bela Vista 2735-337 Caceacutem Portugal E-mail infoajcostairmaoscom URLwwwajcostairmaoscom

Geral Tel (+351) 214 266 500 Fax (+351) 214 262 421 Dep Com [Eliwell Jumo Wika] Tel (+351) 214 266 502 Fax (+351) 214 266 507

Assistecircncia Teacutecnica Tel (+351) 214 266 505 Dep Com Bombas [SIHI Busch] Tel (+351) 214 266 508 Fax (+351) 214 266 506

3

chamber designed to disposes condensate to waste and equipped with safety systems to preventsterilizer effluent from entering the sterilization chamber

An automatic steam condenser exhaust system reduces temperature of exhaust steam flowing to thedrain

The automatic condensing system consisting of a stainless steel heat exchanger converts chambersteam to condensate and disposes condensate to waste Cooling water flow is regulated by the wasteline temperature control system to minimize water usage

On double door units the end frame bulkhead of the chamber are constructed of solid AISI 316Lstainless steel and entirely welded on the pressure vessel

On single door units back of chamber is fitted with welded 316L stainless-steel head

The complete pressure vessel is then mechanically rectified and all mechanical dimensions arecontrolled by a CNC precision-machine

1222 Jacket

The jacket is constructed of AISI 304L stainless steel It is constructed with 2 sheet-metal U-shapedparts Directly on those 2 sheet-metal strength points are mechanical shaped and the jacket is ofentirely welded mounted and welded to the chamber giving reinforcement according to the cross-section of the chamber The jacket along with the chamber is designed to avoid generating hightensions in any point of the structure do to cyclic pressure and temperature variations The jacket isdesigned to achieve uniform distribution of steam and enables the stabilization of temperature aroundthe chamber thereby giving excellent performance during the drying process and reducing the timerequired to bring the chamber up to sterilization temperatures This provides superior temperaturedistribution and prevents the formation of condensation on the chamber walls

The pressure vessel is constructed in accordance with Directive PD 5500 Directive 9723CE e ASMESection VIII Division 1 for unfired pressure vessels

123 Doors

Door(s) are constructed of AISI 316L stainless steel and reinforced mechanically rectified by a CNCprecision-machine which provides uniform quality of inner surface and precise mechanical dimensions

Door(s) are insulated with Rockwool fiber insulation and covered with a finish stainless steel panel

The steam sterilizer is equipped with one or two hinged vertical or horizontal sliding doors accordingto your model

Hinged doors for AJC 50x50 biosafety P3 type laboratory sterilizers can be either left side or right sidehinged Doors are operated with low effort manual lockunlock rotating mechanism and have a speciallock security device When open door(s) angle overture is higher than 90ordm put them totally out of thechamber space allowing safe and complete access to them and to the load

Vertical or horizontal sliding door(s)

Respectively for AJC 70x70 and AJC 70x112 sterilizers have automatic operation and each door isoperated by one pneumatic cylinder mounted at the central inner part of the door The operation of thecylinder is performed by air pressure and acts as a speed and motion control system An adjustablerestrictor controls the flow of compressed air controlling the speed movement of the door Door motionis controlled from the touch screen display Horizontal door models are available with doors that slidefrom left-to-right or right-to-left

AJC 50x50 sterilizers are vertical sliding mechanically powered by an electrical motor maintenance free

with proper device for manual operation in case of electrical power failure When open door(s) are totallyout of the chamber and sealing gasket(s) allowing safe and complete access to them

8162019 Specifications Amaro 5000 amp Steri 21 MD009_04 en a J COSTA (IRMAtildeOS) LDA Desde 1953 Ao Serviccedilo Meacutedico-Hhellip

httpslidepdfcomreaderfullspecifications-amaro-5000-steri-21-md00904-en-a-j-costa-irmaos-lda 410

983117983108983088983088983097983087983088983092 983109983118

A J COSTA (IRMAtildeOS) LDA ndash Desde 1953 ao Serviccedilo Meacutedico-Hospitalar

Estrada das Ligeiras Lote 10 Alto da Bela Vista 2735-337 Caceacutem Portugal E-mail infoajcostairmaoscom URLwwwajcostairmaoscom

Geral Tel (+351) 214 266 500 Fax (+351) 214 262 421 Dep Com [Eliwell Jumo Wika] Tel (+351) 214 266 502 Fax (+351) 214 266 507

Assistecircncia Teacutecnica Tel (+351) 214 266 505 Dep Com Bombas [SIHI Busch] Tel (+351) 214 266 508 Fax (+351) 214 266 506

4

Door(s) are equipped with a sensor safety guard system which automatically stops and reverses thedoor(s) motion if any obstruction is detected along the entire path of travel

The end frame(s) of the chamber are constructed of solid AISI 316L stainless steel and entirely weldedon the pressure vessel The complete pressure vessel is then mechanically rectified and all mechanicaldimensions are controlled by a CNC precision-machine On the chamber end frame the gasket ring slot

is open calibrated and polished by the CNC conferring superior work surface for the recessed silicongasket

The silicon gasket seals the door(s) operated by steam and will maintain a secure seal even in the eventof a total utility loss The gasket is retracted under vacuum when the sterilize cycle is complete

The gaskets are easy to replace and does not require special tools or lubrication

Double door configurations are supplied with controls and security systems at both ends of the sterilizerto prevent the possibility of cross-contamination As a single door steam sterilizer equipment can bemounted as a freestanding unit with covering panel frame (OPTIONAL) or recessed on wall

The single door steam sterilizer will produce loads from and to the same area Provisions must betaken to have clear identified circuits for load the goods to sterilize and unload sterile materials for

storage and distribution

Double door steam sterilizer is mounted through a recessed wall The two doors are located in twoseparate rooms

The front load door on the side of the master control panel is facing the preparation area of thesterilization department from where the steam sterilizer is operated and serves for loading thematerial into the sterilization chamber This area is known as the ldquonon-sterile side

The other door is located on the sterile side and serves for unloading the sterilized material fromthe steam sterilizer chamber The sterile side of the steam sterilizer is equipped with a secondarycontrol panel (slave)

The silicon gasket seals the door(s) operated by steam and will maintain a secure seal even in the

event of a total utility loss The gasket is retracted under vacuum when the sterilize cycle is complete

The gaskets are easy to replace and does not require special tools or lubrication

When open door(s) are totally out of the chamber and sealing gasket(s) allowing safe and completeaccess to them

Door(s) are equipped with a sensor safety guard system which automatically stops and reverses thedoor(s) motion if any obstruction is detected along the entire path of travel

The door(s) are designed to prevent opening while under pressure or in case of electrical power failureby a safety lock mechanism with proper device for manual operation in case of power failure

Door(s) motion and operation have special interlock systems and are based on the following conditions

A cycle cannot be started if the door(s) are not properly closed and lock control system is safelyactuated

A door cannot be opened while the automatic cycle operation of the steam sterilizer is inprogress

A door cannot be opened if the chamber is under pressure

Both doors cannot be opened at the same time Opening of one door automatically locks theother

After opening the door on the unsterile side even after closing it and it being locked and sealedthe door on the clean side can be opened only after performing a complete sterilization cycle

If a cycle failed only the non-sterile side door can be opened and operated After a test cycle only the non-sterile side door can be opened and operated

8162019 Specifications Amaro 5000 amp Steri 21 MD009_04 en a J COSTA (IRMAtildeOS) LDA Desde 1953 Ao Serviccedilo Meacutedico-Hhellip

httpslidepdfcomreaderfullspecifications-amaro-5000-steri-21-md00904-en-a-j-costa-irmaos-lda 510

983117983108983088983088983097983087983088983092 983109983118

A J COSTA (IRMAtildeOS) LDA ndash Desde 1953 ao Serviccedilo Meacutedico-Hospitalar

Estrada das Ligeiras Lote 10 Alto da Bela Vista 2735-337 Caceacutem Portugal E-mail infoajcostairmaoscom URLwwwajcostairmaoscom

Geral Tel (+351) 214 266 500 Fax (+351) 214 262 421 Dep Com [Eliwell Jumo Wika] Tel (+351) 214 266 502 Fax (+351) 214 266 507

Assistecircncia Teacutecnica Tel (+351) 214 266 505 Dep Com Bombas [SIHI Busch] Tel (+351) 214 266 508 Fax (+351) 214 266 506

5

A door cannot be opened at the end of the cycle if the chamber temperature is higher than thepreset final temperature

Double door configurations are supplied with controls and security systems at both ends of the sterilizerto prevent the possibility of cross-contamination

124 Insulation

Superior heat loss reduction to the surrounding environment and heat conservation is achieved withrigid Rockwool fiber insulation overlaid with AISI 304L stainless steel sheet-metal The sheet-metal isformed overlapped and riveted along the pressure vessel The stainless steel sheet makes theinsulation system impervious to water thus eliminating wet condensation

125 Piping

All piping components delivering steam or sterile air to the load are stainless steel threaded and brasscomponents All piping connections terminate within the confines of the sterilizer and are accessible as

standard from front and right side of sterilizer

All major piping pneumatic and electrical components are tagged and numbered to match thediagrams Threaded stainless steel is available as a customer option

Steam traps are thermostatic non-proprietary and NTS (nearly to steam) industrial grade They arepositioned and sized for maximum efficiency Steam traps are used for the removal of air andcondensate from the system

Control valves are non-proprietary industrial grade brass or stainless steel They are actuated byelectric solenoids for air pressure 24V DC Pneumatic valves for steam exhaust and sterile air havespecial connectors to simplify sterilizer piping and can be serviced individually Water control valvesare 24V DC operated Safety valves are approved stamped and sized for the vessel design pressure

126 Vacuum System

Rapid evacuation of chamber air and moisture is achieved with a liquid ring vacuum pump Thevacuum pump reduces the chamber pressure during pre-vacuum and post-drying phases

A water conservation system is used to limit the consumption of the potable water during the processand to guarantee maximum efficiency of the vacuum pump

The liquid ring vacuum pump works in a self-recirculated circuit reducing water consumption Effluentdischarge temperature is further reduced by a dual pass coil bundle heat exchanger before enteringthe vacuum pump The discharge temperature is further reduced by cool water at the floor drain

Cooling water flow is regulated by the waste line temperature controller to minimize water usage Thesystem is designed to work with cold water up to 15ordm C

Following the drying phase chamber vacuum is relieved to atmospheric pressure by an air inletbacteria-retentive filter With an absolute rated membrane efficiently remove all particles down to 001micron thus removing airborne bacteria viruses and bacteriophage It is easy accessible

127 Steam Source

The steam source requires clean house steam and the sterilizers are piped valved and trapped toreceive building supplied steam

Steam must be supplied with particulates removed and be suitably line trapped to ensure that it is dryand supplied at 30 to 35 bar dynamic

8162019 Specifications Amaro 5000 amp Steri 21 MD009_04 en a J COSTA (IRMAtildeOS) LDA Desde 1953 Ao Serviccedilo Meacutedico-Hhellip

httpslidepdfcomreaderfullspecifications-amaro-5000-steri-21-md00904-en-a-j-costa-irmaos-lda 610

983117983108983088983088983097983087983088983092 983109983118

A J COSTA (IRMAtildeOS) LDA ndash Desde 1953 ao Serviccedilo Meacutedico-Hospitalar

Estrada das Ligeiras Lote 10 Alto da Bela Vista 2735-337 Caceacutem Portugal E-mail infoajcostairmaoscom URLwwwajcostairmaoscom

Geral Tel (+351) 214 266 500 Fax (+351) 214 262 421 Dep Com [Eliwell Jumo Wika] Tel (+351) 214 266 502 Fax (+351) 214 266 507

Assistecircncia Teacutecnica Tel (+351) 214 266 505 Dep Com Bombas [SIHI Busch] Tel (+351) 214 266 508 Fax (+351) 214 266 506

6

Standard sterilizer steam piping is constructed of stainless steel and includes a shutoff valve and asteam trap

As buyerrsquos option the steam sterilizer can be equipped with an electrical heated built-in stainless steelAISI 304L steam generator

Depending on the option the built-in steam generator can act as a standby unit if building steam is notavailable for the sterilization process or can be the main source of saturated steam for the sterilizationprocess

If the steam sterilizer have a DUAL OPTION for steam source the steam sterilizer is built to receivetwo steam supply sources namely from the building or from the internal built-in steam generator Thereis a selector function on the user interface to choose the steam source Before selecting the built-ingenerator as steam source check if the steam generator is connected to the electrical supply and it isworking properly

Internal built-in steam generator main features are

bull Water level control system ndash Consists of three capacitive level sensors mounted on anexternal water level sight pipe heat and pressure resistant that allows constant observation of

water level while the steam generator is in operation Water level sensors are not influenced bywater resistivity ensuring work capability with low water conductivity as reverse osmosis waterquality Water level is automatically controlled maintaining the proper working level and shuts ofthe heating elements when water supply drops below a safe operating level

bull Heating elements ndash Long life heavy duty stainless steel AISI 316 heating elements welded onan AISI 316 stainless steel flange for added strength and safety

bull Water pressurizing pump ndash The water pump supplies distilled or mineral-free water to thesteam generator The water pump ensures that water inlet pressure to the steam generator isnot dependent of the facility water inlet pressure

bull Operating pressure control ndash Operates automatically to maintain steam pressure at working

defined range

bull Steam pressure safety valve ndash Certified pressure relief valve that automatically opens toreduce pressure should excessive steam cause pressure build-up

bull Blow downdrain valve ndash Facilitates emptying the steam generator during blow downdrainsequence Automatic blow down as OPTION

bull Steam pressure gauge ndash Positioned at service area allows visual observation of steampressure over full range

128 Control System

The gauges touchpad and printer are mounted in the stainless fascia panel

The electronic control system and software monitors and controls all sterilizer operations and functionsand are designed to operate up to 16 different factory-programed standard sterilization and testprograms

The control system of the sterilizer is based on microcomputer technology ensuring a highly reliableand safe operation The computerized control unit ensures a fully automatic operation through theentire process hence after setting the pre-selected parameters and starting the operation no furtheroperator intervention is necessary

Factory pre-set programs are intended for instruments in containers single or double wrappedinstruments and packs wrapped fabrics heat and moisture sensitive materials prions cycle slow

exhaust pressure cycles for sterilizing liquids in borosilicate containers with vented closures and warm-up cycle In addition there are two test programs Bowie amp Dick Test and the Vacuum Leak Test

8162019 Specifications Amaro 5000 amp Steri 21 MD009_04 en a J COSTA (IRMAtildeOS) LDA Desde 1953 Ao Serviccedilo Meacutedico-Hhellip

httpslidepdfcomreaderfullspecifications-amaro-5000-steri-21-md00904-en-a-j-costa-irmaos-lda 710

983117983108983088983088983097983087983088983092 983109983118

A J COSTA (IRMAtildeOS) LDA ndash Desde 1953 ao Serviccedilo Meacutedico-Hospitalar

Estrada das Ligeiras Lote 10 Alto da Bela Vista 2735-337 Caceacutem Portugal E-mail infoajcostairmaoscom URLwwwajcostairmaoscom

Geral Tel (+351) 214 266 500 Fax (+351) 214 262 421 Dep Com [Eliwell Jumo Wika] Tel (+351) 214 266 502 Fax (+351) 214 266 507

Assistecircncia Teacutecnica Tel (+351) 214 266 505 Dep Com Bombas [SIHI Busch] Tel (+351) 214 266 508 Fax (+351) 214 266 506

7

Special propose sterilizers for biosafety P3 type laboratories have cycles for contaminated wastematerial in bags or special containers

Special propose sterilizers for biosafety P3 type laboratories may be provided with dual controlcapabilities allowing for pass-through sterilization of materials entering into containment areasdecontamination of used items and waste leaving that area and as single door sterilization applications

from either side of the sterilizer or only from and to the containment areaThe sterilizers AJC are equipped with laboratory work cycles standardly programmed In order to

perform the laboratory work cycles the sterilizer should also be supplied with an additional accessory

a product probe to accurately measure the temperature inside the liquid to be sterilized

The laboratory work cycles include cycles for liquids in open containers The operator is able to choose

if the process of initial evacuation is assisted by vacuum or not as well as whether it is a fast or slow

exhaustion process The laboratory work cycles also enable the selection of temperature the contact

time for sterilization and the possibility of controlling the process by F0 function

In addition to laboratory work cycles the sterilizers AJC are also programmed with test work cyclesBowie amp Dick and vacuum cycles along with sterilization cycles for glassware and wrapped or

unwrapped instruments for immediate use with drying phase assisted by vacuum

As optional the sterilizer can be equipped with sterilization work cycles specially designed for animal

cages These cycles enable the operator to program different process parameters including

temperature contact time of sterilization and drying time The process of air exhaustion is automatically

controlled and implemented through an HEPA filter sterilized by steam allowing the operator to control

efficiently the process of sterilization of contaminated materials

As optional the sterilizer can also be equipped with two sterilization work cycles for pet food diet

These cycles allow the operator to program different process parameters including the temperaturecontact time for sterilization selection of initial air removal stage and final stage of drying by vacuum

assisted It is also possible to set the drying time vacuum control and the possibility of drying control

assisted by residual humidity

The working cycles are completely customizable according to customer needs since it is possible toprogram 18 different sterilization cycles

A list of real-time process critical values the selected program the main phases of the cycletemperature pressure and the status of the machine are controlled and displayed on a color touchscreen digital display with graphical display (Plot Graph) For process documentation all the relevantinformation concerning operation is printed

The touch screen allows the user to operate and program the steam sterilizer control by touching(pressing) the appropriate touch-sensitive areas on the display On each screen all rectangular-outlined boxes are touch-sensitive areas referred to as buttons

The color touch screen display and keyboards located on both the non-sterile and sterile panelsenables including but not limited to the operator to select a sterilization program startstop a cycleand close or open a door

A programming mode which can be accessed by a code from the unsterile panel display only enablestechnicians to set up the system set and change a number of additional parameters and operationalmodes and perform calibration

As default the user has access to cycle selection cycle start and door control Users can only runfactory-set cycles and test cycles Access to other functions such as setting parameters calibration

8162019 Specifications Amaro 5000 amp Steri 21 MD009_04 en a J COSTA (IRMAtildeOS) LDA Desde 1953 Ao Serviccedilo Meacutedico-Hhellip

httpslidepdfcomreaderfullspecifications-amaro-5000-steri-21-md00904-en-a-j-costa-irmaos-lda 810

983117983108983088983088983097983087983088983092 983109983118

A J COSTA (IRMAtildeOS) LDA ndash Desde 1953 ao Serviccedilo Meacutedico-Hospitalar

Estrada das Ligeiras Lote 10 Alto da Bela Vista 2735-337 Caceacutem Portugal E-mail infoajcostairmaoscom URLwwwajcostairmaoscom

Geral Tel (+351) 214 266 500 Fax (+351) 214 262 421 Dep Com [Eliwell Jumo Wika] Tel (+351) 214 266 502 Fax (+351) 214 266 507

Assistecircncia Teacutecnica Tel (+351) 214 266 505 Dep Com Bombas [SIHI Busch] Tel (+351) 214 266 508 Fax (+351) 214 266 506

8

service and maintenance procedures is controlled using pre-defined access levels and passwordspreventing unauthorized access

Each cycle is adjustable to meet specific processing requirements All user-accessible control functionscan be changed using the touch screen control Cycle parameters are retained in control memory forrepeated use Once cycle is started cycles and cycle values cannot be changed until cycle is

complete The system features a comprehensive alarmalert system with automatic triggering of pre-programmable information alerts The self-diagnostic program monitors the sterilizer performanceautomatically and process check-up and failure corrections

In case of a malfunction during the sterilization cycle the process enters in an emergency alarm phasewhich safely will end the process automatically

Alarm range includes

bull Temperature pressure sensor and analogue input failure

bull Power failure

bull Door(s) failure

bull Gasket and chamber sealing failure

bull Phase Timeout

bull Doors safety interlock failure

bull Water supply failure

bull Steam failure

bull Compressed air failure

bull Vacuum Pump failure

bull Microcomputer failure

The bar Graph screen displays the chamber temperature and pressure as a bar graph and also showsa digital time representing the time remaining in the cycle The Plot Graph screen displays the chambertemperature and pressure as a trend curve using a graphic display

A process data record printer and a graphic recorder (as OPTIONAL) are mounted at the non -sterileside to record all relevant process information like program cycle steps time temperature pressuredate cycle start time both sterilizer and daily cycle number total cycle count fault conditions userverification and signature and load information

Data is automatically printed at the beginning and at the end of each cycle with all transition pointrsquosinformation and summary verification of time at selected temperaturepressure (minmax values)performed during cycle operation

The microcomputer stores the cycle data and in case of printer failure during the cycle or on demandthe user can reprint the last cycle

As buyerrsquos option the steam sterilizer can be equipped with a load temperature probe inside thesterilization chamber and perform sterilization based F0 control The control system allows control ofliquid sterilization by F0 value rather than time and temperature This mode of control may optionally beused for heat sensitive liquids

Before operating the sterilizer it is important to become familiar with the location and function of allmajor components and controls

As OPTIONAL the record system can be mounted on the ldquosterile siderdquo

8162019 Specifications Amaro 5000 amp Steri 21 MD009_04 en a J COSTA (IRMAtildeOS) LDA Desde 1953 Ao Serviccedilo Meacutedico-Hhellip

httpslidepdfcomreaderfullspecifications-amaro-5000-steri-21-md00904-en-a-j-costa-irmaos-lda 910

983117983108983088983088983097983087983088983092 983109983118

A J COSTA (IRMAtildeOS) LDA ndash Desde 1953 ao Serviccedilo Meacutedico-Hospitalar

Estrada das Ligeiras Lote 10 Alto da Bela Vista 2735-337 Caceacutem Portugal E-mail infoajcostairmaoscom URLwwwajcostairmaoscom

Geral Tel (+351) 214 266 500 Fax (+351) 214 262 421 Dep Com [Eliwell Jumo Wika] Tel (+351) 214 266 502 Fax (+351) 214 266 507

Assistecircncia Teacutecnica Tel (+351) 214 266 505 Dep Com Bombas [SIHI Busch] Tel (+351) 214 266 508 Fax (+351) 214 266 506

9

The steam sterilizer has an automatic shutdown system If no operation is performed after anadjustable time it will go into an energy conservation mode Sterilizer utilities can be restarted as soonthe user starts or selects a new cycle

129 Temperature and Pressure Sensors and Gauges

The system is equipped with up to four temperature sensors two absolute pressure transducers fourpressure gauges and safety devices having the following functions

The temperature sensors

In the drain ndash control of heat exchanger drain and liquid ring vacuum pump watertemperature

In the chamber condensate line (double independent PT100 probe) ndash controlmonitoring and printout of sterilization process temperature

Inside the chamber (flexible PT100 probe as OPTIONAL for liquids) ndash controlmonitoring and printout of load sterilization process temperature

The absolute pressure transducers

Chamber pressure ndash control display monitoring and printout

Jacket pressure ndash control display monitoring and printout

The pressure gauges (front panel as OPTIONAL)

Front Panel

Steam source pressure (built-in steam generator or building steam supply)

Chamber pressure

Jacket pressure

Service Area

Steam source pressure (built-in steam generator andor building steam supply)

The safety devices

Pressure Safety Valves

Built-in steam generator certified pre-set pressure calibrated for 34 bar gauge

Chamber certified pre-set pressure calibrated for 24 bar gauge

Jacket certified pre-set pressure calibrated for 26 bar gauge

Door(s) end switch

Open and close position prevents the inlet of steam pressure to the chamber andto the door gasket if the door is not closed

Door(s) safety lock

Safety lock mechanism with proper device for manual operation preventing theopening of in case of power failure preventing the door from opening in case ofelectrical power or compressed air failure

Door(s) sensor safety

Two sensors for safety guard system on each door which automatically stopsand reverses the door(s) motion if any obstruction is detected along the entire

path of travel preventing the door from trapping any object while closingEmergency Stop push-buttons

8162019 Specifications Amaro 5000 amp Steri 21 MD009_04 en a J COSTA (IRMAtildeOS) LDA Desde 1953 Ao Serviccedilo Meacutedico-Hhellip

httpslidepdfcomreaderfullspecifications-amaro-5000-steri-21-md00904-en-a-j-costa-irmaos-lda 1010

983117983108983088983088983097983087983088983092 983109983118

A J COSTA (IRMAtildeOS) LDA ndash Desde 1953 ao Serviccedilo Meacutedico-Hospitalar

Estrada das Ligeiras Lote 10 Alto da Bela Vista 2735-337 Caceacutem Portugal E-mail infoajcostairmaoscom URLwwwajcostairmaoscom

Geral Tel (+351) 214 266 500 Fax (+351) 214 262 421 Dep Com [Eliwell Jumo Wika] Tel (+351) 214 266 502 Fax (+351) 214 266 507

10

Mounted on both the unsterile and sterile panel This feature is designed toprevent human hazards accidents or equipment breakdown in compliance withthe European Standards EN-285 requirements

13 Standards

A J Costa (Irmatildeos) Lda meets the provisions of the Medical Device Directive 9342EEC and PED9723EEC and the following standards

EN 2852006 - Sterilization - Steam sterilizers - Large sterilizers

ISO 17665-12006 ndash Sterilization of health care products - Moist heat - Part 1 Requirements forthe development validation and routine control of a sterilization process for medical devices

ASME Section VIII Division I for unfired pressure vessels - ASME Boiler and pressurevessel code

IEC 61010-2-0402005 ndash Safety requirements for electrical equipment for measurement controland laboratory use ndash Part 2 ndash 040 Particular requirements for sterilizers and washer-disinfectorsused to treat medical materials

IEC 61326-12005 ndash Electrical equipment for measurement control and laboratory use ndash EMCrequirements ndash Part 1 General requirements

A J Costa (Irmatildeos) Lda is also approved for

ISO 9001 (Quality Management Systems)

ISO 13485 (Medical devices mdash Quality management systems ndash Requirements for regulatorypurposes )

Page 4: Specifications. Amaro 5000 & Steri 21 MD009_04 en. a. J. COSTA (IRMÃOS), LDA. Desde 1953 Ao Serviço Médico-Hospitalar

8162019 Specifications Amaro 5000 amp Steri 21 MD009_04 en a J COSTA (IRMAtildeOS) LDA Desde 1953 Ao Serviccedilo Meacutedico-Hhellip

httpslidepdfcomreaderfullspecifications-amaro-5000-steri-21-md00904-en-a-j-costa-irmaos-lda 410

983117983108983088983088983097983087983088983092 983109983118

A J COSTA (IRMAtildeOS) LDA ndash Desde 1953 ao Serviccedilo Meacutedico-Hospitalar

Estrada das Ligeiras Lote 10 Alto da Bela Vista 2735-337 Caceacutem Portugal E-mail infoajcostairmaoscom URLwwwajcostairmaoscom

Geral Tel (+351) 214 266 500 Fax (+351) 214 262 421 Dep Com [Eliwell Jumo Wika] Tel (+351) 214 266 502 Fax (+351) 214 266 507

Assistecircncia Teacutecnica Tel (+351) 214 266 505 Dep Com Bombas [SIHI Busch] Tel (+351) 214 266 508 Fax (+351) 214 266 506

4

Door(s) are equipped with a sensor safety guard system which automatically stops and reverses thedoor(s) motion if any obstruction is detected along the entire path of travel

The end frame(s) of the chamber are constructed of solid AISI 316L stainless steel and entirely weldedon the pressure vessel The complete pressure vessel is then mechanically rectified and all mechanicaldimensions are controlled by a CNC precision-machine On the chamber end frame the gasket ring slot

is open calibrated and polished by the CNC conferring superior work surface for the recessed silicongasket

The silicon gasket seals the door(s) operated by steam and will maintain a secure seal even in the eventof a total utility loss The gasket is retracted under vacuum when the sterilize cycle is complete

The gaskets are easy to replace and does not require special tools or lubrication

Double door configurations are supplied with controls and security systems at both ends of the sterilizerto prevent the possibility of cross-contamination As a single door steam sterilizer equipment can bemounted as a freestanding unit with covering panel frame (OPTIONAL) or recessed on wall

The single door steam sterilizer will produce loads from and to the same area Provisions must betaken to have clear identified circuits for load the goods to sterilize and unload sterile materials for

storage and distribution

Double door steam sterilizer is mounted through a recessed wall The two doors are located in twoseparate rooms

The front load door on the side of the master control panel is facing the preparation area of thesterilization department from where the steam sterilizer is operated and serves for loading thematerial into the sterilization chamber This area is known as the ldquonon-sterile side

The other door is located on the sterile side and serves for unloading the sterilized material fromthe steam sterilizer chamber The sterile side of the steam sterilizer is equipped with a secondarycontrol panel (slave)

The silicon gasket seals the door(s) operated by steam and will maintain a secure seal even in the

event of a total utility loss The gasket is retracted under vacuum when the sterilize cycle is complete

The gaskets are easy to replace and does not require special tools or lubrication

When open door(s) are totally out of the chamber and sealing gasket(s) allowing safe and completeaccess to them

Door(s) are equipped with a sensor safety guard system which automatically stops and reverses thedoor(s) motion if any obstruction is detected along the entire path of travel

The door(s) are designed to prevent opening while under pressure or in case of electrical power failureby a safety lock mechanism with proper device for manual operation in case of power failure

Door(s) motion and operation have special interlock systems and are based on the following conditions

A cycle cannot be started if the door(s) are not properly closed and lock control system is safelyactuated

A door cannot be opened while the automatic cycle operation of the steam sterilizer is inprogress

A door cannot be opened if the chamber is under pressure

Both doors cannot be opened at the same time Opening of one door automatically locks theother

After opening the door on the unsterile side even after closing it and it being locked and sealedthe door on the clean side can be opened only after performing a complete sterilization cycle

If a cycle failed only the non-sterile side door can be opened and operated After a test cycle only the non-sterile side door can be opened and operated

8162019 Specifications Amaro 5000 amp Steri 21 MD009_04 en a J COSTA (IRMAtildeOS) LDA Desde 1953 Ao Serviccedilo Meacutedico-Hhellip

httpslidepdfcomreaderfullspecifications-amaro-5000-steri-21-md00904-en-a-j-costa-irmaos-lda 510

983117983108983088983088983097983087983088983092 983109983118

A J COSTA (IRMAtildeOS) LDA ndash Desde 1953 ao Serviccedilo Meacutedico-Hospitalar

Estrada das Ligeiras Lote 10 Alto da Bela Vista 2735-337 Caceacutem Portugal E-mail infoajcostairmaoscom URLwwwajcostairmaoscom

Geral Tel (+351) 214 266 500 Fax (+351) 214 262 421 Dep Com [Eliwell Jumo Wika] Tel (+351) 214 266 502 Fax (+351) 214 266 507

Assistecircncia Teacutecnica Tel (+351) 214 266 505 Dep Com Bombas [SIHI Busch] Tel (+351) 214 266 508 Fax (+351) 214 266 506

5

A door cannot be opened at the end of the cycle if the chamber temperature is higher than thepreset final temperature

Double door configurations are supplied with controls and security systems at both ends of the sterilizerto prevent the possibility of cross-contamination

124 Insulation

Superior heat loss reduction to the surrounding environment and heat conservation is achieved withrigid Rockwool fiber insulation overlaid with AISI 304L stainless steel sheet-metal The sheet-metal isformed overlapped and riveted along the pressure vessel The stainless steel sheet makes theinsulation system impervious to water thus eliminating wet condensation

125 Piping

All piping components delivering steam or sterile air to the load are stainless steel threaded and brasscomponents All piping connections terminate within the confines of the sterilizer and are accessible as

standard from front and right side of sterilizer

All major piping pneumatic and electrical components are tagged and numbered to match thediagrams Threaded stainless steel is available as a customer option

Steam traps are thermostatic non-proprietary and NTS (nearly to steam) industrial grade They arepositioned and sized for maximum efficiency Steam traps are used for the removal of air andcondensate from the system

Control valves are non-proprietary industrial grade brass or stainless steel They are actuated byelectric solenoids for air pressure 24V DC Pneumatic valves for steam exhaust and sterile air havespecial connectors to simplify sterilizer piping and can be serviced individually Water control valvesare 24V DC operated Safety valves are approved stamped and sized for the vessel design pressure

126 Vacuum System

Rapid evacuation of chamber air and moisture is achieved with a liquid ring vacuum pump Thevacuum pump reduces the chamber pressure during pre-vacuum and post-drying phases

A water conservation system is used to limit the consumption of the potable water during the processand to guarantee maximum efficiency of the vacuum pump

The liquid ring vacuum pump works in a self-recirculated circuit reducing water consumption Effluentdischarge temperature is further reduced by a dual pass coil bundle heat exchanger before enteringthe vacuum pump The discharge temperature is further reduced by cool water at the floor drain

Cooling water flow is regulated by the waste line temperature controller to minimize water usage Thesystem is designed to work with cold water up to 15ordm C

Following the drying phase chamber vacuum is relieved to atmospheric pressure by an air inletbacteria-retentive filter With an absolute rated membrane efficiently remove all particles down to 001micron thus removing airborne bacteria viruses and bacteriophage It is easy accessible

127 Steam Source

The steam source requires clean house steam and the sterilizers are piped valved and trapped toreceive building supplied steam

Steam must be supplied with particulates removed and be suitably line trapped to ensure that it is dryand supplied at 30 to 35 bar dynamic

8162019 Specifications Amaro 5000 amp Steri 21 MD009_04 en a J COSTA (IRMAtildeOS) LDA Desde 1953 Ao Serviccedilo Meacutedico-Hhellip

httpslidepdfcomreaderfullspecifications-amaro-5000-steri-21-md00904-en-a-j-costa-irmaos-lda 610

983117983108983088983088983097983087983088983092 983109983118

A J COSTA (IRMAtildeOS) LDA ndash Desde 1953 ao Serviccedilo Meacutedico-Hospitalar

Estrada das Ligeiras Lote 10 Alto da Bela Vista 2735-337 Caceacutem Portugal E-mail infoajcostairmaoscom URLwwwajcostairmaoscom

Geral Tel (+351) 214 266 500 Fax (+351) 214 262 421 Dep Com [Eliwell Jumo Wika] Tel (+351) 214 266 502 Fax (+351) 214 266 507

Assistecircncia Teacutecnica Tel (+351) 214 266 505 Dep Com Bombas [SIHI Busch] Tel (+351) 214 266 508 Fax (+351) 214 266 506

6

Standard sterilizer steam piping is constructed of stainless steel and includes a shutoff valve and asteam trap

As buyerrsquos option the steam sterilizer can be equipped with an electrical heated built-in stainless steelAISI 304L steam generator

Depending on the option the built-in steam generator can act as a standby unit if building steam is notavailable for the sterilization process or can be the main source of saturated steam for the sterilizationprocess

If the steam sterilizer have a DUAL OPTION for steam source the steam sterilizer is built to receivetwo steam supply sources namely from the building or from the internal built-in steam generator Thereis a selector function on the user interface to choose the steam source Before selecting the built-ingenerator as steam source check if the steam generator is connected to the electrical supply and it isworking properly

Internal built-in steam generator main features are

bull Water level control system ndash Consists of three capacitive level sensors mounted on anexternal water level sight pipe heat and pressure resistant that allows constant observation of

water level while the steam generator is in operation Water level sensors are not influenced bywater resistivity ensuring work capability with low water conductivity as reverse osmosis waterquality Water level is automatically controlled maintaining the proper working level and shuts ofthe heating elements when water supply drops below a safe operating level

bull Heating elements ndash Long life heavy duty stainless steel AISI 316 heating elements welded onan AISI 316 stainless steel flange for added strength and safety

bull Water pressurizing pump ndash The water pump supplies distilled or mineral-free water to thesteam generator The water pump ensures that water inlet pressure to the steam generator isnot dependent of the facility water inlet pressure

bull Operating pressure control ndash Operates automatically to maintain steam pressure at working

defined range

bull Steam pressure safety valve ndash Certified pressure relief valve that automatically opens toreduce pressure should excessive steam cause pressure build-up

bull Blow downdrain valve ndash Facilitates emptying the steam generator during blow downdrainsequence Automatic blow down as OPTION

bull Steam pressure gauge ndash Positioned at service area allows visual observation of steampressure over full range

128 Control System

The gauges touchpad and printer are mounted in the stainless fascia panel

The electronic control system and software monitors and controls all sterilizer operations and functionsand are designed to operate up to 16 different factory-programed standard sterilization and testprograms

The control system of the sterilizer is based on microcomputer technology ensuring a highly reliableand safe operation The computerized control unit ensures a fully automatic operation through theentire process hence after setting the pre-selected parameters and starting the operation no furtheroperator intervention is necessary

Factory pre-set programs are intended for instruments in containers single or double wrappedinstruments and packs wrapped fabrics heat and moisture sensitive materials prions cycle slow

exhaust pressure cycles for sterilizing liquids in borosilicate containers with vented closures and warm-up cycle In addition there are two test programs Bowie amp Dick Test and the Vacuum Leak Test

8162019 Specifications Amaro 5000 amp Steri 21 MD009_04 en a J COSTA (IRMAtildeOS) LDA Desde 1953 Ao Serviccedilo Meacutedico-Hhellip

httpslidepdfcomreaderfullspecifications-amaro-5000-steri-21-md00904-en-a-j-costa-irmaos-lda 710

983117983108983088983088983097983087983088983092 983109983118

A J COSTA (IRMAtildeOS) LDA ndash Desde 1953 ao Serviccedilo Meacutedico-Hospitalar

Estrada das Ligeiras Lote 10 Alto da Bela Vista 2735-337 Caceacutem Portugal E-mail infoajcostairmaoscom URLwwwajcostairmaoscom

Geral Tel (+351) 214 266 500 Fax (+351) 214 262 421 Dep Com [Eliwell Jumo Wika] Tel (+351) 214 266 502 Fax (+351) 214 266 507

Assistecircncia Teacutecnica Tel (+351) 214 266 505 Dep Com Bombas [SIHI Busch] Tel (+351) 214 266 508 Fax (+351) 214 266 506

7

Special propose sterilizers for biosafety P3 type laboratories have cycles for contaminated wastematerial in bags or special containers

Special propose sterilizers for biosafety P3 type laboratories may be provided with dual controlcapabilities allowing for pass-through sterilization of materials entering into containment areasdecontamination of used items and waste leaving that area and as single door sterilization applications

from either side of the sterilizer or only from and to the containment areaThe sterilizers AJC are equipped with laboratory work cycles standardly programmed In order to

perform the laboratory work cycles the sterilizer should also be supplied with an additional accessory

a product probe to accurately measure the temperature inside the liquid to be sterilized

The laboratory work cycles include cycles for liquids in open containers The operator is able to choose

if the process of initial evacuation is assisted by vacuum or not as well as whether it is a fast or slow

exhaustion process The laboratory work cycles also enable the selection of temperature the contact

time for sterilization and the possibility of controlling the process by F0 function

In addition to laboratory work cycles the sterilizers AJC are also programmed with test work cyclesBowie amp Dick and vacuum cycles along with sterilization cycles for glassware and wrapped or

unwrapped instruments for immediate use with drying phase assisted by vacuum

As optional the sterilizer can be equipped with sterilization work cycles specially designed for animal

cages These cycles enable the operator to program different process parameters including

temperature contact time of sterilization and drying time The process of air exhaustion is automatically

controlled and implemented through an HEPA filter sterilized by steam allowing the operator to control

efficiently the process of sterilization of contaminated materials

As optional the sterilizer can also be equipped with two sterilization work cycles for pet food diet

These cycles allow the operator to program different process parameters including the temperaturecontact time for sterilization selection of initial air removal stage and final stage of drying by vacuum

assisted It is also possible to set the drying time vacuum control and the possibility of drying control

assisted by residual humidity

The working cycles are completely customizable according to customer needs since it is possible toprogram 18 different sterilization cycles

A list of real-time process critical values the selected program the main phases of the cycletemperature pressure and the status of the machine are controlled and displayed on a color touchscreen digital display with graphical display (Plot Graph) For process documentation all the relevantinformation concerning operation is printed

The touch screen allows the user to operate and program the steam sterilizer control by touching(pressing) the appropriate touch-sensitive areas on the display On each screen all rectangular-outlined boxes are touch-sensitive areas referred to as buttons

The color touch screen display and keyboards located on both the non-sterile and sterile panelsenables including but not limited to the operator to select a sterilization program startstop a cycleand close or open a door

A programming mode which can be accessed by a code from the unsterile panel display only enablestechnicians to set up the system set and change a number of additional parameters and operationalmodes and perform calibration

As default the user has access to cycle selection cycle start and door control Users can only runfactory-set cycles and test cycles Access to other functions such as setting parameters calibration

8162019 Specifications Amaro 5000 amp Steri 21 MD009_04 en a J COSTA (IRMAtildeOS) LDA Desde 1953 Ao Serviccedilo Meacutedico-Hhellip

httpslidepdfcomreaderfullspecifications-amaro-5000-steri-21-md00904-en-a-j-costa-irmaos-lda 810

983117983108983088983088983097983087983088983092 983109983118

A J COSTA (IRMAtildeOS) LDA ndash Desde 1953 ao Serviccedilo Meacutedico-Hospitalar

Estrada das Ligeiras Lote 10 Alto da Bela Vista 2735-337 Caceacutem Portugal E-mail infoajcostairmaoscom URLwwwajcostairmaoscom

Geral Tel (+351) 214 266 500 Fax (+351) 214 262 421 Dep Com [Eliwell Jumo Wika] Tel (+351) 214 266 502 Fax (+351) 214 266 507

Assistecircncia Teacutecnica Tel (+351) 214 266 505 Dep Com Bombas [SIHI Busch] Tel (+351) 214 266 508 Fax (+351) 214 266 506

8

service and maintenance procedures is controlled using pre-defined access levels and passwordspreventing unauthorized access

Each cycle is adjustable to meet specific processing requirements All user-accessible control functionscan be changed using the touch screen control Cycle parameters are retained in control memory forrepeated use Once cycle is started cycles and cycle values cannot be changed until cycle is

complete The system features a comprehensive alarmalert system with automatic triggering of pre-programmable information alerts The self-diagnostic program monitors the sterilizer performanceautomatically and process check-up and failure corrections

In case of a malfunction during the sterilization cycle the process enters in an emergency alarm phasewhich safely will end the process automatically

Alarm range includes

bull Temperature pressure sensor and analogue input failure

bull Power failure

bull Door(s) failure

bull Gasket and chamber sealing failure

bull Phase Timeout

bull Doors safety interlock failure

bull Water supply failure

bull Steam failure

bull Compressed air failure

bull Vacuum Pump failure

bull Microcomputer failure

The bar Graph screen displays the chamber temperature and pressure as a bar graph and also showsa digital time representing the time remaining in the cycle The Plot Graph screen displays the chambertemperature and pressure as a trend curve using a graphic display

A process data record printer and a graphic recorder (as OPTIONAL) are mounted at the non -sterileside to record all relevant process information like program cycle steps time temperature pressuredate cycle start time both sterilizer and daily cycle number total cycle count fault conditions userverification and signature and load information

Data is automatically printed at the beginning and at the end of each cycle with all transition pointrsquosinformation and summary verification of time at selected temperaturepressure (minmax values)performed during cycle operation

The microcomputer stores the cycle data and in case of printer failure during the cycle or on demandthe user can reprint the last cycle

As buyerrsquos option the steam sterilizer can be equipped with a load temperature probe inside thesterilization chamber and perform sterilization based F0 control The control system allows control ofliquid sterilization by F0 value rather than time and temperature This mode of control may optionally beused for heat sensitive liquids

Before operating the sterilizer it is important to become familiar with the location and function of allmajor components and controls

As OPTIONAL the record system can be mounted on the ldquosterile siderdquo

8162019 Specifications Amaro 5000 amp Steri 21 MD009_04 en a J COSTA (IRMAtildeOS) LDA Desde 1953 Ao Serviccedilo Meacutedico-Hhellip

httpslidepdfcomreaderfullspecifications-amaro-5000-steri-21-md00904-en-a-j-costa-irmaos-lda 910

983117983108983088983088983097983087983088983092 983109983118

A J COSTA (IRMAtildeOS) LDA ndash Desde 1953 ao Serviccedilo Meacutedico-Hospitalar

Estrada das Ligeiras Lote 10 Alto da Bela Vista 2735-337 Caceacutem Portugal E-mail infoajcostairmaoscom URLwwwajcostairmaoscom

Geral Tel (+351) 214 266 500 Fax (+351) 214 262 421 Dep Com [Eliwell Jumo Wika] Tel (+351) 214 266 502 Fax (+351) 214 266 507

Assistecircncia Teacutecnica Tel (+351) 214 266 505 Dep Com Bombas [SIHI Busch] Tel (+351) 214 266 508 Fax (+351) 214 266 506

9

The steam sterilizer has an automatic shutdown system If no operation is performed after anadjustable time it will go into an energy conservation mode Sterilizer utilities can be restarted as soonthe user starts or selects a new cycle

129 Temperature and Pressure Sensors and Gauges

The system is equipped with up to four temperature sensors two absolute pressure transducers fourpressure gauges and safety devices having the following functions

The temperature sensors

In the drain ndash control of heat exchanger drain and liquid ring vacuum pump watertemperature

In the chamber condensate line (double independent PT100 probe) ndash controlmonitoring and printout of sterilization process temperature

Inside the chamber (flexible PT100 probe as OPTIONAL for liquids) ndash controlmonitoring and printout of load sterilization process temperature

The absolute pressure transducers

Chamber pressure ndash control display monitoring and printout

Jacket pressure ndash control display monitoring and printout

The pressure gauges (front panel as OPTIONAL)

Front Panel

Steam source pressure (built-in steam generator or building steam supply)

Chamber pressure

Jacket pressure

Service Area

Steam source pressure (built-in steam generator andor building steam supply)

The safety devices

Pressure Safety Valves

Built-in steam generator certified pre-set pressure calibrated for 34 bar gauge

Chamber certified pre-set pressure calibrated for 24 bar gauge

Jacket certified pre-set pressure calibrated for 26 bar gauge

Door(s) end switch

Open and close position prevents the inlet of steam pressure to the chamber andto the door gasket if the door is not closed

Door(s) safety lock

Safety lock mechanism with proper device for manual operation preventing theopening of in case of power failure preventing the door from opening in case ofelectrical power or compressed air failure

Door(s) sensor safety

Two sensors for safety guard system on each door which automatically stopsand reverses the door(s) motion if any obstruction is detected along the entire

path of travel preventing the door from trapping any object while closingEmergency Stop push-buttons

8162019 Specifications Amaro 5000 amp Steri 21 MD009_04 en a J COSTA (IRMAtildeOS) LDA Desde 1953 Ao Serviccedilo Meacutedico-Hhellip

httpslidepdfcomreaderfullspecifications-amaro-5000-steri-21-md00904-en-a-j-costa-irmaos-lda 1010

983117983108983088983088983097983087983088983092 983109983118

A J COSTA (IRMAtildeOS) LDA ndash Desde 1953 ao Serviccedilo Meacutedico-Hospitalar

Estrada das Ligeiras Lote 10 Alto da Bela Vista 2735-337 Caceacutem Portugal E-mail infoajcostairmaoscom URLwwwajcostairmaoscom

Geral Tel (+351) 214 266 500 Fax (+351) 214 262 421 Dep Com [Eliwell Jumo Wika] Tel (+351) 214 266 502 Fax (+351) 214 266 507

10

Mounted on both the unsterile and sterile panel This feature is designed toprevent human hazards accidents or equipment breakdown in compliance withthe European Standards EN-285 requirements

13 Standards

A J Costa (Irmatildeos) Lda meets the provisions of the Medical Device Directive 9342EEC and PED9723EEC and the following standards

EN 2852006 - Sterilization - Steam sterilizers - Large sterilizers

ISO 17665-12006 ndash Sterilization of health care products - Moist heat - Part 1 Requirements forthe development validation and routine control of a sterilization process for medical devices

ASME Section VIII Division I for unfired pressure vessels - ASME Boiler and pressurevessel code

IEC 61010-2-0402005 ndash Safety requirements for electrical equipment for measurement controland laboratory use ndash Part 2 ndash 040 Particular requirements for sterilizers and washer-disinfectorsused to treat medical materials

IEC 61326-12005 ndash Electrical equipment for measurement control and laboratory use ndash EMCrequirements ndash Part 1 General requirements

A J Costa (Irmatildeos) Lda is also approved for

ISO 9001 (Quality Management Systems)

ISO 13485 (Medical devices mdash Quality management systems ndash Requirements for regulatorypurposes )

Page 5: Specifications. Amaro 5000 & Steri 21 MD009_04 en. a. J. COSTA (IRMÃOS), LDA. Desde 1953 Ao Serviço Médico-Hospitalar

8162019 Specifications Amaro 5000 amp Steri 21 MD009_04 en a J COSTA (IRMAtildeOS) LDA Desde 1953 Ao Serviccedilo Meacutedico-Hhellip

httpslidepdfcomreaderfullspecifications-amaro-5000-steri-21-md00904-en-a-j-costa-irmaos-lda 510

983117983108983088983088983097983087983088983092 983109983118

A J COSTA (IRMAtildeOS) LDA ndash Desde 1953 ao Serviccedilo Meacutedico-Hospitalar

Estrada das Ligeiras Lote 10 Alto da Bela Vista 2735-337 Caceacutem Portugal E-mail infoajcostairmaoscom URLwwwajcostairmaoscom

Geral Tel (+351) 214 266 500 Fax (+351) 214 262 421 Dep Com [Eliwell Jumo Wika] Tel (+351) 214 266 502 Fax (+351) 214 266 507

Assistecircncia Teacutecnica Tel (+351) 214 266 505 Dep Com Bombas [SIHI Busch] Tel (+351) 214 266 508 Fax (+351) 214 266 506

5

A door cannot be opened at the end of the cycle if the chamber temperature is higher than thepreset final temperature

Double door configurations are supplied with controls and security systems at both ends of the sterilizerto prevent the possibility of cross-contamination

124 Insulation

Superior heat loss reduction to the surrounding environment and heat conservation is achieved withrigid Rockwool fiber insulation overlaid with AISI 304L stainless steel sheet-metal The sheet-metal isformed overlapped and riveted along the pressure vessel The stainless steel sheet makes theinsulation system impervious to water thus eliminating wet condensation

125 Piping

All piping components delivering steam or sterile air to the load are stainless steel threaded and brasscomponents All piping connections terminate within the confines of the sterilizer and are accessible as

standard from front and right side of sterilizer

All major piping pneumatic and electrical components are tagged and numbered to match thediagrams Threaded stainless steel is available as a customer option

Steam traps are thermostatic non-proprietary and NTS (nearly to steam) industrial grade They arepositioned and sized for maximum efficiency Steam traps are used for the removal of air andcondensate from the system

Control valves are non-proprietary industrial grade brass or stainless steel They are actuated byelectric solenoids for air pressure 24V DC Pneumatic valves for steam exhaust and sterile air havespecial connectors to simplify sterilizer piping and can be serviced individually Water control valvesare 24V DC operated Safety valves are approved stamped and sized for the vessel design pressure

126 Vacuum System

Rapid evacuation of chamber air and moisture is achieved with a liquid ring vacuum pump Thevacuum pump reduces the chamber pressure during pre-vacuum and post-drying phases

A water conservation system is used to limit the consumption of the potable water during the processand to guarantee maximum efficiency of the vacuum pump

The liquid ring vacuum pump works in a self-recirculated circuit reducing water consumption Effluentdischarge temperature is further reduced by a dual pass coil bundle heat exchanger before enteringthe vacuum pump The discharge temperature is further reduced by cool water at the floor drain

Cooling water flow is regulated by the waste line temperature controller to minimize water usage Thesystem is designed to work with cold water up to 15ordm C

Following the drying phase chamber vacuum is relieved to atmospheric pressure by an air inletbacteria-retentive filter With an absolute rated membrane efficiently remove all particles down to 001micron thus removing airborne bacteria viruses and bacteriophage It is easy accessible

127 Steam Source

The steam source requires clean house steam and the sterilizers are piped valved and trapped toreceive building supplied steam

Steam must be supplied with particulates removed and be suitably line trapped to ensure that it is dryand supplied at 30 to 35 bar dynamic

8162019 Specifications Amaro 5000 amp Steri 21 MD009_04 en a J COSTA (IRMAtildeOS) LDA Desde 1953 Ao Serviccedilo Meacutedico-Hhellip

httpslidepdfcomreaderfullspecifications-amaro-5000-steri-21-md00904-en-a-j-costa-irmaos-lda 610

983117983108983088983088983097983087983088983092 983109983118

A J COSTA (IRMAtildeOS) LDA ndash Desde 1953 ao Serviccedilo Meacutedico-Hospitalar

Estrada das Ligeiras Lote 10 Alto da Bela Vista 2735-337 Caceacutem Portugal E-mail infoajcostairmaoscom URLwwwajcostairmaoscom

Geral Tel (+351) 214 266 500 Fax (+351) 214 262 421 Dep Com [Eliwell Jumo Wika] Tel (+351) 214 266 502 Fax (+351) 214 266 507

Assistecircncia Teacutecnica Tel (+351) 214 266 505 Dep Com Bombas [SIHI Busch] Tel (+351) 214 266 508 Fax (+351) 214 266 506

6

Standard sterilizer steam piping is constructed of stainless steel and includes a shutoff valve and asteam trap

As buyerrsquos option the steam sterilizer can be equipped with an electrical heated built-in stainless steelAISI 304L steam generator

Depending on the option the built-in steam generator can act as a standby unit if building steam is notavailable for the sterilization process or can be the main source of saturated steam for the sterilizationprocess

If the steam sterilizer have a DUAL OPTION for steam source the steam sterilizer is built to receivetwo steam supply sources namely from the building or from the internal built-in steam generator Thereis a selector function on the user interface to choose the steam source Before selecting the built-ingenerator as steam source check if the steam generator is connected to the electrical supply and it isworking properly

Internal built-in steam generator main features are

bull Water level control system ndash Consists of three capacitive level sensors mounted on anexternal water level sight pipe heat and pressure resistant that allows constant observation of

water level while the steam generator is in operation Water level sensors are not influenced bywater resistivity ensuring work capability with low water conductivity as reverse osmosis waterquality Water level is automatically controlled maintaining the proper working level and shuts ofthe heating elements when water supply drops below a safe operating level

bull Heating elements ndash Long life heavy duty stainless steel AISI 316 heating elements welded onan AISI 316 stainless steel flange for added strength and safety

bull Water pressurizing pump ndash The water pump supplies distilled or mineral-free water to thesteam generator The water pump ensures that water inlet pressure to the steam generator isnot dependent of the facility water inlet pressure

bull Operating pressure control ndash Operates automatically to maintain steam pressure at working

defined range

bull Steam pressure safety valve ndash Certified pressure relief valve that automatically opens toreduce pressure should excessive steam cause pressure build-up

bull Blow downdrain valve ndash Facilitates emptying the steam generator during blow downdrainsequence Automatic blow down as OPTION

bull Steam pressure gauge ndash Positioned at service area allows visual observation of steampressure over full range

128 Control System

The gauges touchpad and printer are mounted in the stainless fascia panel

The electronic control system and software monitors and controls all sterilizer operations and functionsand are designed to operate up to 16 different factory-programed standard sterilization and testprograms

The control system of the sterilizer is based on microcomputer technology ensuring a highly reliableand safe operation The computerized control unit ensures a fully automatic operation through theentire process hence after setting the pre-selected parameters and starting the operation no furtheroperator intervention is necessary

Factory pre-set programs are intended for instruments in containers single or double wrappedinstruments and packs wrapped fabrics heat and moisture sensitive materials prions cycle slow

exhaust pressure cycles for sterilizing liquids in borosilicate containers with vented closures and warm-up cycle In addition there are two test programs Bowie amp Dick Test and the Vacuum Leak Test

8162019 Specifications Amaro 5000 amp Steri 21 MD009_04 en a J COSTA (IRMAtildeOS) LDA Desde 1953 Ao Serviccedilo Meacutedico-Hhellip

httpslidepdfcomreaderfullspecifications-amaro-5000-steri-21-md00904-en-a-j-costa-irmaos-lda 710

983117983108983088983088983097983087983088983092 983109983118

A J COSTA (IRMAtildeOS) LDA ndash Desde 1953 ao Serviccedilo Meacutedico-Hospitalar

Estrada das Ligeiras Lote 10 Alto da Bela Vista 2735-337 Caceacutem Portugal E-mail infoajcostairmaoscom URLwwwajcostairmaoscom

Geral Tel (+351) 214 266 500 Fax (+351) 214 262 421 Dep Com [Eliwell Jumo Wika] Tel (+351) 214 266 502 Fax (+351) 214 266 507

Assistecircncia Teacutecnica Tel (+351) 214 266 505 Dep Com Bombas [SIHI Busch] Tel (+351) 214 266 508 Fax (+351) 214 266 506

7

Special propose sterilizers for biosafety P3 type laboratories have cycles for contaminated wastematerial in bags or special containers

Special propose sterilizers for biosafety P3 type laboratories may be provided with dual controlcapabilities allowing for pass-through sterilization of materials entering into containment areasdecontamination of used items and waste leaving that area and as single door sterilization applications

from either side of the sterilizer or only from and to the containment areaThe sterilizers AJC are equipped with laboratory work cycles standardly programmed In order to

perform the laboratory work cycles the sterilizer should also be supplied with an additional accessory

a product probe to accurately measure the temperature inside the liquid to be sterilized

The laboratory work cycles include cycles for liquids in open containers The operator is able to choose

if the process of initial evacuation is assisted by vacuum or not as well as whether it is a fast or slow

exhaustion process The laboratory work cycles also enable the selection of temperature the contact

time for sterilization and the possibility of controlling the process by F0 function

In addition to laboratory work cycles the sterilizers AJC are also programmed with test work cyclesBowie amp Dick and vacuum cycles along with sterilization cycles for glassware and wrapped or

unwrapped instruments for immediate use with drying phase assisted by vacuum

As optional the sterilizer can be equipped with sterilization work cycles specially designed for animal

cages These cycles enable the operator to program different process parameters including

temperature contact time of sterilization and drying time The process of air exhaustion is automatically

controlled and implemented through an HEPA filter sterilized by steam allowing the operator to control

efficiently the process of sterilization of contaminated materials

As optional the sterilizer can also be equipped with two sterilization work cycles for pet food diet

These cycles allow the operator to program different process parameters including the temperaturecontact time for sterilization selection of initial air removal stage and final stage of drying by vacuum

assisted It is also possible to set the drying time vacuum control and the possibility of drying control

assisted by residual humidity

The working cycles are completely customizable according to customer needs since it is possible toprogram 18 different sterilization cycles

A list of real-time process critical values the selected program the main phases of the cycletemperature pressure and the status of the machine are controlled and displayed on a color touchscreen digital display with graphical display (Plot Graph) For process documentation all the relevantinformation concerning operation is printed

The touch screen allows the user to operate and program the steam sterilizer control by touching(pressing) the appropriate touch-sensitive areas on the display On each screen all rectangular-outlined boxes are touch-sensitive areas referred to as buttons

The color touch screen display and keyboards located on both the non-sterile and sterile panelsenables including but not limited to the operator to select a sterilization program startstop a cycleand close or open a door

A programming mode which can be accessed by a code from the unsterile panel display only enablestechnicians to set up the system set and change a number of additional parameters and operationalmodes and perform calibration

As default the user has access to cycle selection cycle start and door control Users can only runfactory-set cycles and test cycles Access to other functions such as setting parameters calibration

8162019 Specifications Amaro 5000 amp Steri 21 MD009_04 en a J COSTA (IRMAtildeOS) LDA Desde 1953 Ao Serviccedilo Meacutedico-Hhellip

httpslidepdfcomreaderfullspecifications-amaro-5000-steri-21-md00904-en-a-j-costa-irmaos-lda 810

983117983108983088983088983097983087983088983092 983109983118

A J COSTA (IRMAtildeOS) LDA ndash Desde 1953 ao Serviccedilo Meacutedico-Hospitalar

Estrada das Ligeiras Lote 10 Alto da Bela Vista 2735-337 Caceacutem Portugal E-mail infoajcostairmaoscom URLwwwajcostairmaoscom

Geral Tel (+351) 214 266 500 Fax (+351) 214 262 421 Dep Com [Eliwell Jumo Wika] Tel (+351) 214 266 502 Fax (+351) 214 266 507

Assistecircncia Teacutecnica Tel (+351) 214 266 505 Dep Com Bombas [SIHI Busch] Tel (+351) 214 266 508 Fax (+351) 214 266 506

8

service and maintenance procedures is controlled using pre-defined access levels and passwordspreventing unauthorized access

Each cycle is adjustable to meet specific processing requirements All user-accessible control functionscan be changed using the touch screen control Cycle parameters are retained in control memory forrepeated use Once cycle is started cycles and cycle values cannot be changed until cycle is

complete The system features a comprehensive alarmalert system with automatic triggering of pre-programmable information alerts The self-diagnostic program monitors the sterilizer performanceautomatically and process check-up and failure corrections

In case of a malfunction during the sterilization cycle the process enters in an emergency alarm phasewhich safely will end the process automatically

Alarm range includes

bull Temperature pressure sensor and analogue input failure

bull Power failure

bull Door(s) failure

bull Gasket and chamber sealing failure

bull Phase Timeout

bull Doors safety interlock failure

bull Water supply failure

bull Steam failure

bull Compressed air failure

bull Vacuum Pump failure

bull Microcomputer failure

The bar Graph screen displays the chamber temperature and pressure as a bar graph and also showsa digital time representing the time remaining in the cycle The Plot Graph screen displays the chambertemperature and pressure as a trend curve using a graphic display

A process data record printer and a graphic recorder (as OPTIONAL) are mounted at the non -sterileside to record all relevant process information like program cycle steps time temperature pressuredate cycle start time both sterilizer and daily cycle number total cycle count fault conditions userverification and signature and load information

Data is automatically printed at the beginning and at the end of each cycle with all transition pointrsquosinformation and summary verification of time at selected temperaturepressure (minmax values)performed during cycle operation

The microcomputer stores the cycle data and in case of printer failure during the cycle or on demandthe user can reprint the last cycle

As buyerrsquos option the steam sterilizer can be equipped with a load temperature probe inside thesterilization chamber and perform sterilization based F0 control The control system allows control ofliquid sterilization by F0 value rather than time and temperature This mode of control may optionally beused for heat sensitive liquids

Before operating the sterilizer it is important to become familiar with the location and function of allmajor components and controls

As OPTIONAL the record system can be mounted on the ldquosterile siderdquo

8162019 Specifications Amaro 5000 amp Steri 21 MD009_04 en a J COSTA (IRMAtildeOS) LDA Desde 1953 Ao Serviccedilo Meacutedico-Hhellip

httpslidepdfcomreaderfullspecifications-amaro-5000-steri-21-md00904-en-a-j-costa-irmaos-lda 910

983117983108983088983088983097983087983088983092 983109983118

A J COSTA (IRMAtildeOS) LDA ndash Desde 1953 ao Serviccedilo Meacutedico-Hospitalar

Estrada das Ligeiras Lote 10 Alto da Bela Vista 2735-337 Caceacutem Portugal E-mail infoajcostairmaoscom URLwwwajcostairmaoscom

Geral Tel (+351) 214 266 500 Fax (+351) 214 262 421 Dep Com [Eliwell Jumo Wika] Tel (+351) 214 266 502 Fax (+351) 214 266 507

Assistecircncia Teacutecnica Tel (+351) 214 266 505 Dep Com Bombas [SIHI Busch] Tel (+351) 214 266 508 Fax (+351) 214 266 506

9

The steam sterilizer has an automatic shutdown system If no operation is performed after anadjustable time it will go into an energy conservation mode Sterilizer utilities can be restarted as soonthe user starts or selects a new cycle

129 Temperature and Pressure Sensors and Gauges

The system is equipped with up to four temperature sensors two absolute pressure transducers fourpressure gauges and safety devices having the following functions

The temperature sensors

In the drain ndash control of heat exchanger drain and liquid ring vacuum pump watertemperature

In the chamber condensate line (double independent PT100 probe) ndash controlmonitoring and printout of sterilization process temperature

Inside the chamber (flexible PT100 probe as OPTIONAL for liquids) ndash controlmonitoring and printout of load sterilization process temperature

The absolute pressure transducers

Chamber pressure ndash control display monitoring and printout

Jacket pressure ndash control display monitoring and printout

The pressure gauges (front panel as OPTIONAL)

Front Panel

Steam source pressure (built-in steam generator or building steam supply)

Chamber pressure

Jacket pressure

Service Area

Steam source pressure (built-in steam generator andor building steam supply)

The safety devices

Pressure Safety Valves

Built-in steam generator certified pre-set pressure calibrated for 34 bar gauge

Chamber certified pre-set pressure calibrated for 24 bar gauge

Jacket certified pre-set pressure calibrated for 26 bar gauge

Door(s) end switch

Open and close position prevents the inlet of steam pressure to the chamber andto the door gasket if the door is not closed

Door(s) safety lock

Safety lock mechanism with proper device for manual operation preventing theopening of in case of power failure preventing the door from opening in case ofelectrical power or compressed air failure

Door(s) sensor safety

Two sensors for safety guard system on each door which automatically stopsand reverses the door(s) motion if any obstruction is detected along the entire

path of travel preventing the door from trapping any object while closingEmergency Stop push-buttons

8162019 Specifications Amaro 5000 amp Steri 21 MD009_04 en a J COSTA (IRMAtildeOS) LDA Desde 1953 Ao Serviccedilo Meacutedico-Hhellip

httpslidepdfcomreaderfullspecifications-amaro-5000-steri-21-md00904-en-a-j-costa-irmaos-lda 1010

983117983108983088983088983097983087983088983092 983109983118

A J COSTA (IRMAtildeOS) LDA ndash Desde 1953 ao Serviccedilo Meacutedico-Hospitalar

Estrada das Ligeiras Lote 10 Alto da Bela Vista 2735-337 Caceacutem Portugal E-mail infoajcostairmaoscom URLwwwajcostairmaoscom

Geral Tel (+351) 214 266 500 Fax (+351) 214 262 421 Dep Com [Eliwell Jumo Wika] Tel (+351) 214 266 502 Fax (+351) 214 266 507

10

Mounted on both the unsterile and sterile panel This feature is designed toprevent human hazards accidents or equipment breakdown in compliance withthe European Standards EN-285 requirements

13 Standards

A J Costa (Irmatildeos) Lda meets the provisions of the Medical Device Directive 9342EEC and PED9723EEC and the following standards

EN 2852006 - Sterilization - Steam sterilizers - Large sterilizers

ISO 17665-12006 ndash Sterilization of health care products - Moist heat - Part 1 Requirements forthe development validation and routine control of a sterilization process for medical devices

ASME Section VIII Division I for unfired pressure vessels - ASME Boiler and pressurevessel code

IEC 61010-2-0402005 ndash Safety requirements for electrical equipment for measurement controland laboratory use ndash Part 2 ndash 040 Particular requirements for sterilizers and washer-disinfectorsused to treat medical materials

IEC 61326-12005 ndash Electrical equipment for measurement control and laboratory use ndash EMCrequirements ndash Part 1 General requirements

A J Costa (Irmatildeos) Lda is also approved for

ISO 9001 (Quality Management Systems)

ISO 13485 (Medical devices mdash Quality management systems ndash Requirements for regulatorypurposes )

Page 6: Specifications. Amaro 5000 & Steri 21 MD009_04 en. a. J. COSTA (IRMÃOS), LDA. Desde 1953 Ao Serviço Médico-Hospitalar

8162019 Specifications Amaro 5000 amp Steri 21 MD009_04 en a J COSTA (IRMAtildeOS) LDA Desde 1953 Ao Serviccedilo Meacutedico-Hhellip

httpslidepdfcomreaderfullspecifications-amaro-5000-steri-21-md00904-en-a-j-costa-irmaos-lda 610

983117983108983088983088983097983087983088983092 983109983118

A J COSTA (IRMAtildeOS) LDA ndash Desde 1953 ao Serviccedilo Meacutedico-Hospitalar

Estrada das Ligeiras Lote 10 Alto da Bela Vista 2735-337 Caceacutem Portugal E-mail infoajcostairmaoscom URLwwwajcostairmaoscom

Geral Tel (+351) 214 266 500 Fax (+351) 214 262 421 Dep Com [Eliwell Jumo Wika] Tel (+351) 214 266 502 Fax (+351) 214 266 507

Assistecircncia Teacutecnica Tel (+351) 214 266 505 Dep Com Bombas [SIHI Busch] Tel (+351) 214 266 508 Fax (+351) 214 266 506

6

Standard sterilizer steam piping is constructed of stainless steel and includes a shutoff valve and asteam trap

As buyerrsquos option the steam sterilizer can be equipped with an electrical heated built-in stainless steelAISI 304L steam generator

Depending on the option the built-in steam generator can act as a standby unit if building steam is notavailable for the sterilization process or can be the main source of saturated steam for the sterilizationprocess

If the steam sterilizer have a DUAL OPTION for steam source the steam sterilizer is built to receivetwo steam supply sources namely from the building or from the internal built-in steam generator Thereis a selector function on the user interface to choose the steam source Before selecting the built-ingenerator as steam source check if the steam generator is connected to the electrical supply and it isworking properly

Internal built-in steam generator main features are

bull Water level control system ndash Consists of three capacitive level sensors mounted on anexternal water level sight pipe heat and pressure resistant that allows constant observation of

water level while the steam generator is in operation Water level sensors are not influenced bywater resistivity ensuring work capability with low water conductivity as reverse osmosis waterquality Water level is automatically controlled maintaining the proper working level and shuts ofthe heating elements when water supply drops below a safe operating level

bull Heating elements ndash Long life heavy duty stainless steel AISI 316 heating elements welded onan AISI 316 stainless steel flange for added strength and safety

bull Water pressurizing pump ndash The water pump supplies distilled or mineral-free water to thesteam generator The water pump ensures that water inlet pressure to the steam generator isnot dependent of the facility water inlet pressure

bull Operating pressure control ndash Operates automatically to maintain steam pressure at working

defined range

bull Steam pressure safety valve ndash Certified pressure relief valve that automatically opens toreduce pressure should excessive steam cause pressure build-up

bull Blow downdrain valve ndash Facilitates emptying the steam generator during blow downdrainsequence Automatic blow down as OPTION

bull Steam pressure gauge ndash Positioned at service area allows visual observation of steampressure over full range

128 Control System

The gauges touchpad and printer are mounted in the stainless fascia panel

The electronic control system and software monitors and controls all sterilizer operations and functionsand are designed to operate up to 16 different factory-programed standard sterilization and testprograms

The control system of the sterilizer is based on microcomputer technology ensuring a highly reliableand safe operation The computerized control unit ensures a fully automatic operation through theentire process hence after setting the pre-selected parameters and starting the operation no furtheroperator intervention is necessary

Factory pre-set programs are intended for instruments in containers single or double wrappedinstruments and packs wrapped fabrics heat and moisture sensitive materials prions cycle slow

exhaust pressure cycles for sterilizing liquids in borosilicate containers with vented closures and warm-up cycle In addition there are two test programs Bowie amp Dick Test and the Vacuum Leak Test

8162019 Specifications Amaro 5000 amp Steri 21 MD009_04 en a J COSTA (IRMAtildeOS) LDA Desde 1953 Ao Serviccedilo Meacutedico-Hhellip

httpslidepdfcomreaderfullspecifications-amaro-5000-steri-21-md00904-en-a-j-costa-irmaos-lda 710

983117983108983088983088983097983087983088983092 983109983118

A J COSTA (IRMAtildeOS) LDA ndash Desde 1953 ao Serviccedilo Meacutedico-Hospitalar

Estrada das Ligeiras Lote 10 Alto da Bela Vista 2735-337 Caceacutem Portugal E-mail infoajcostairmaoscom URLwwwajcostairmaoscom

Geral Tel (+351) 214 266 500 Fax (+351) 214 262 421 Dep Com [Eliwell Jumo Wika] Tel (+351) 214 266 502 Fax (+351) 214 266 507

Assistecircncia Teacutecnica Tel (+351) 214 266 505 Dep Com Bombas [SIHI Busch] Tel (+351) 214 266 508 Fax (+351) 214 266 506

7

Special propose sterilizers for biosafety P3 type laboratories have cycles for contaminated wastematerial in bags or special containers

Special propose sterilizers for biosafety P3 type laboratories may be provided with dual controlcapabilities allowing for pass-through sterilization of materials entering into containment areasdecontamination of used items and waste leaving that area and as single door sterilization applications

from either side of the sterilizer or only from and to the containment areaThe sterilizers AJC are equipped with laboratory work cycles standardly programmed In order to

perform the laboratory work cycles the sterilizer should also be supplied with an additional accessory

a product probe to accurately measure the temperature inside the liquid to be sterilized

The laboratory work cycles include cycles for liquids in open containers The operator is able to choose

if the process of initial evacuation is assisted by vacuum or not as well as whether it is a fast or slow

exhaustion process The laboratory work cycles also enable the selection of temperature the contact

time for sterilization and the possibility of controlling the process by F0 function

In addition to laboratory work cycles the sterilizers AJC are also programmed with test work cyclesBowie amp Dick and vacuum cycles along with sterilization cycles for glassware and wrapped or

unwrapped instruments for immediate use with drying phase assisted by vacuum

As optional the sterilizer can be equipped with sterilization work cycles specially designed for animal

cages These cycles enable the operator to program different process parameters including

temperature contact time of sterilization and drying time The process of air exhaustion is automatically

controlled and implemented through an HEPA filter sterilized by steam allowing the operator to control

efficiently the process of sterilization of contaminated materials

As optional the sterilizer can also be equipped with two sterilization work cycles for pet food diet

These cycles allow the operator to program different process parameters including the temperaturecontact time for sterilization selection of initial air removal stage and final stage of drying by vacuum

assisted It is also possible to set the drying time vacuum control and the possibility of drying control

assisted by residual humidity

The working cycles are completely customizable according to customer needs since it is possible toprogram 18 different sterilization cycles

A list of real-time process critical values the selected program the main phases of the cycletemperature pressure and the status of the machine are controlled and displayed on a color touchscreen digital display with graphical display (Plot Graph) For process documentation all the relevantinformation concerning operation is printed

The touch screen allows the user to operate and program the steam sterilizer control by touching(pressing) the appropriate touch-sensitive areas on the display On each screen all rectangular-outlined boxes are touch-sensitive areas referred to as buttons

The color touch screen display and keyboards located on both the non-sterile and sterile panelsenables including but not limited to the operator to select a sterilization program startstop a cycleand close or open a door

A programming mode which can be accessed by a code from the unsterile panel display only enablestechnicians to set up the system set and change a number of additional parameters and operationalmodes and perform calibration

As default the user has access to cycle selection cycle start and door control Users can only runfactory-set cycles and test cycles Access to other functions such as setting parameters calibration

8162019 Specifications Amaro 5000 amp Steri 21 MD009_04 en a J COSTA (IRMAtildeOS) LDA Desde 1953 Ao Serviccedilo Meacutedico-Hhellip

httpslidepdfcomreaderfullspecifications-amaro-5000-steri-21-md00904-en-a-j-costa-irmaos-lda 810

983117983108983088983088983097983087983088983092 983109983118

A J COSTA (IRMAtildeOS) LDA ndash Desde 1953 ao Serviccedilo Meacutedico-Hospitalar

Estrada das Ligeiras Lote 10 Alto da Bela Vista 2735-337 Caceacutem Portugal E-mail infoajcostairmaoscom URLwwwajcostairmaoscom

Geral Tel (+351) 214 266 500 Fax (+351) 214 262 421 Dep Com [Eliwell Jumo Wika] Tel (+351) 214 266 502 Fax (+351) 214 266 507

Assistecircncia Teacutecnica Tel (+351) 214 266 505 Dep Com Bombas [SIHI Busch] Tel (+351) 214 266 508 Fax (+351) 214 266 506

8

service and maintenance procedures is controlled using pre-defined access levels and passwordspreventing unauthorized access

Each cycle is adjustable to meet specific processing requirements All user-accessible control functionscan be changed using the touch screen control Cycle parameters are retained in control memory forrepeated use Once cycle is started cycles and cycle values cannot be changed until cycle is

complete The system features a comprehensive alarmalert system with automatic triggering of pre-programmable information alerts The self-diagnostic program monitors the sterilizer performanceautomatically and process check-up and failure corrections

In case of a malfunction during the sterilization cycle the process enters in an emergency alarm phasewhich safely will end the process automatically

Alarm range includes

bull Temperature pressure sensor and analogue input failure

bull Power failure

bull Door(s) failure

bull Gasket and chamber sealing failure

bull Phase Timeout

bull Doors safety interlock failure

bull Water supply failure

bull Steam failure

bull Compressed air failure

bull Vacuum Pump failure

bull Microcomputer failure

The bar Graph screen displays the chamber temperature and pressure as a bar graph and also showsa digital time representing the time remaining in the cycle The Plot Graph screen displays the chambertemperature and pressure as a trend curve using a graphic display

A process data record printer and a graphic recorder (as OPTIONAL) are mounted at the non -sterileside to record all relevant process information like program cycle steps time temperature pressuredate cycle start time both sterilizer and daily cycle number total cycle count fault conditions userverification and signature and load information

Data is automatically printed at the beginning and at the end of each cycle with all transition pointrsquosinformation and summary verification of time at selected temperaturepressure (minmax values)performed during cycle operation

The microcomputer stores the cycle data and in case of printer failure during the cycle or on demandthe user can reprint the last cycle

As buyerrsquos option the steam sterilizer can be equipped with a load temperature probe inside thesterilization chamber and perform sterilization based F0 control The control system allows control ofliquid sterilization by F0 value rather than time and temperature This mode of control may optionally beused for heat sensitive liquids

Before operating the sterilizer it is important to become familiar with the location and function of allmajor components and controls

As OPTIONAL the record system can be mounted on the ldquosterile siderdquo

8162019 Specifications Amaro 5000 amp Steri 21 MD009_04 en a J COSTA (IRMAtildeOS) LDA Desde 1953 Ao Serviccedilo Meacutedico-Hhellip

httpslidepdfcomreaderfullspecifications-amaro-5000-steri-21-md00904-en-a-j-costa-irmaos-lda 910

983117983108983088983088983097983087983088983092 983109983118

A J COSTA (IRMAtildeOS) LDA ndash Desde 1953 ao Serviccedilo Meacutedico-Hospitalar

Estrada das Ligeiras Lote 10 Alto da Bela Vista 2735-337 Caceacutem Portugal E-mail infoajcostairmaoscom URLwwwajcostairmaoscom

Geral Tel (+351) 214 266 500 Fax (+351) 214 262 421 Dep Com [Eliwell Jumo Wika] Tel (+351) 214 266 502 Fax (+351) 214 266 507

Assistecircncia Teacutecnica Tel (+351) 214 266 505 Dep Com Bombas [SIHI Busch] Tel (+351) 214 266 508 Fax (+351) 214 266 506

9

The steam sterilizer has an automatic shutdown system If no operation is performed after anadjustable time it will go into an energy conservation mode Sterilizer utilities can be restarted as soonthe user starts or selects a new cycle

129 Temperature and Pressure Sensors and Gauges

The system is equipped with up to four temperature sensors two absolute pressure transducers fourpressure gauges and safety devices having the following functions

The temperature sensors

In the drain ndash control of heat exchanger drain and liquid ring vacuum pump watertemperature

In the chamber condensate line (double independent PT100 probe) ndash controlmonitoring and printout of sterilization process temperature

Inside the chamber (flexible PT100 probe as OPTIONAL for liquids) ndash controlmonitoring and printout of load sterilization process temperature

The absolute pressure transducers

Chamber pressure ndash control display monitoring and printout

Jacket pressure ndash control display monitoring and printout

The pressure gauges (front panel as OPTIONAL)

Front Panel

Steam source pressure (built-in steam generator or building steam supply)

Chamber pressure

Jacket pressure

Service Area

Steam source pressure (built-in steam generator andor building steam supply)

The safety devices

Pressure Safety Valves

Built-in steam generator certified pre-set pressure calibrated for 34 bar gauge

Chamber certified pre-set pressure calibrated for 24 bar gauge

Jacket certified pre-set pressure calibrated for 26 bar gauge

Door(s) end switch

Open and close position prevents the inlet of steam pressure to the chamber andto the door gasket if the door is not closed

Door(s) safety lock

Safety lock mechanism with proper device for manual operation preventing theopening of in case of power failure preventing the door from opening in case ofelectrical power or compressed air failure

Door(s) sensor safety

Two sensors for safety guard system on each door which automatically stopsand reverses the door(s) motion if any obstruction is detected along the entire

path of travel preventing the door from trapping any object while closingEmergency Stop push-buttons

8162019 Specifications Amaro 5000 amp Steri 21 MD009_04 en a J COSTA (IRMAtildeOS) LDA Desde 1953 Ao Serviccedilo Meacutedico-Hhellip

httpslidepdfcomreaderfullspecifications-amaro-5000-steri-21-md00904-en-a-j-costa-irmaos-lda 1010

983117983108983088983088983097983087983088983092 983109983118

A J COSTA (IRMAtildeOS) LDA ndash Desde 1953 ao Serviccedilo Meacutedico-Hospitalar

Estrada das Ligeiras Lote 10 Alto da Bela Vista 2735-337 Caceacutem Portugal E-mail infoajcostairmaoscom URLwwwajcostairmaoscom

Geral Tel (+351) 214 266 500 Fax (+351) 214 262 421 Dep Com [Eliwell Jumo Wika] Tel (+351) 214 266 502 Fax (+351) 214 266 507

10

Mounted on both the unsterile and sterile panel This feature is designed toprevent human hazards accidents or equipment breakdown in compliance withthe European Standards EN-285 requirements

13 Standards

A J Costa (Irmatildeos) Lda meets the provisions of the Medical Device Directive 9342EEC and PED9723EEC and the following standards

EN 2852006 - Sterilization - Steam sterilizers - Large sterilizers

ISO 17665-12006 ndash Sterilization of health care products - Moist heat - Part 1 Requirements forthe development validation and routine control of a sterilization process for medical devices

ASME Section VIII Division I for unfired pressure vessels - ASME Boiler and pressurevessel code

IEC 61010-2-0402005 ndash Safety requirements for electrical equipment for measurement controland laboratory use ndash Part 2 ndash 040 Particular requirements for sterilizers and washer-disinfectorsused to treat medical materials

IEC 61326-12005 ndash Electrical equipment for measurement control and laboratory use ndash EMCrequirements ndash Part 1 General requirements

A J Costa (Irmatildeos) Lda is also approved for

ISO 9001 (Quality Management Systems)

ISO 13485 (Medical devices mdash Quality management systems ndash Requirements for regulatorypurposes )

Page 7: Specifications. Amaro 5000 & Steri 21 MD009_04 en. a. J. COSTA (IRMÃOS), LDA. Desde 1953 Ao Serviço Médico-Hospitalar

8162019 Specifications Amaro 5000 amp Steri 21 MD009_04 en a J COSTA (IRMAtildeOS) LDA Desde 1953 Ao Serviccedilo Meacutedico-Hhellip

httpslidepdfcomreaderfullspecifications-amaro-5000-steri-21-md00904-en-a-j-costa-irmaos-lda 710

983117983108983088983088983097983087983088983092 983109983118

A J COSTA (IRMAtildeOS) LDA ndash Desde 1953 ao Serviccedilo Meacutedico-Hospitalar

Estrada das Ligeiras Lote 10 Alto da Bela Vista 2735-337 Caceacutem Portugal E-mail infoajcostairmaoscom URLwwwajcostairmaoscom

Geral Tel (+351) 214 266 500 Fax (+351) 214 262 421 Dep Com [Eliwell Jumo Wika] Tel (+351) 214 266 502 Fax (+351) 214 266 507

Assistecircncia Teacutecnica Tel (+351) 214 266 505 Dep Com Bombas [SIHI Busch] Tel (+351) 214 266 508 Fax (+351) 214 266 506

7

Special propose sterilizers for biosafety P3 type laboratories have cycles for contaminated wastematerial in bags or special containers

Special propose sterilizers for biosafety P3 type laboratories may be provided with dual controlcapabilities allowing for pass-through sterilization of materials entering into containment areasdecontamination of used items and waste leaving that area and as single door sterilization applications

from either side of the sterilizer or only from and to the containment areaThe sterilizers AJC are equipped with laboratory work cycles standardly programmed In order to

perform the laboratory work cycles the sterilizer should also be supplied with an additional accessory

a product probe to accurately measure the temperature inside the liquid to be sterilized

The laboratory work cycles include cycles for liquids in open containers The operator is able to choose

if the process of initial evacuation is assisted by vacuum or not as well as whether it is a fast or slow

exhaustion process The laboratory work cycles also enable the selection of temperature the contact

time for sterilization and the possibility of controlling the process by F0 function

In addition to laboratory work cycles the sterilizers AJC are also programmed with test work cyclesBowie amp Dick and vacuum cycles along with sterilization cycles for glassware and wrapped or

unwrapped instruments for immediate use with drying phase assisted by vacuum

As optional the sterilizer can be equipped with sterilization work cycles specially designed for animal

cages These cycles enable the operator to program different process parameters including

temperature contact time of sterilization and drying time The process of air exhaustion is automatically

controlled and implemented through an HEPA filter sterilized by steam allowing the operator to control

efficiently the process of sterilization of contaminated materials

As optional the sterilizer can also be equipped with two sterilization work cycles for pet food diet

These cycles allow the operator to program different process parameters including the temperaturecontact time for sterilization selection of initial air removal stage and final stage of drying by vacuum

assisted It is also possible to set the drying time vacuum control and the possibility of drying control

assisted by residual humidity

The working cycles are completely customizable according to customer needs since it is possible toprogram 18 different sterilization cycles

A list of real-time process critical values the selected program the main phases of the cycletemperature pressure and the status of the machine are controlled and displayed on a color touchscreen digital display with graphical display (Plot Graph) For process documentation all the relevantinformation concerning operation is printed

The touch screen allows the user to operate and program the steam sterilizer control by touching(pressing) the appropriate touch-sensitive areas on the display On each screen all rectangular-outlined boxes are touch-sensitive areas referred to as buttons

The color touch screen display and keyboards located on both the non-sterile and sterile panelsenables including but not limited to the operator to select a sterilization program startstop a cycleand close or open a door

A programming mode which can be accessed by a code from the unsterile panel display only enablestechnicians to set up the system set and change a number of additional parameters and operationalmodes and perform calibration

As default the user has access to cycle selection cycle start and door control Users can only runfactory-set cycles and test cycles Access to other functions such as setting parameters calibration

8162019 Specifications Amaro 5000 amp Steri 21 MD009_04 en a J COSTA (IRMAtildeOS) LDA Desde 1953 Ao Serviccedilo Meacutedico-Hhellip

httpslidepdfcomreaderfullspecifications-amaro-5000-steri-21-md00904-en-a-j-costa-irmaos-lda 810

983117983108983088983088983097983087983088983092 983109983118

A J COSTA (IRMAtildeOS) LDA ndash Desde 1953 ao Serviccedilo Meacutedico-Hospitalar

Estrada das Ligeiras Lote 10 Alto da Bela Vista 2735-337 Caceacutem Portugal E-mail infoajcostairmaoscom URLwwwajcostairmaoscom

Geral Tel (+351) 214 266 500 Fax (+351) 214 262 421 Dep Com [Eliwell Jumo Wika] Tel (+351) 214 266 502 Fax (+351) 214 266 507

Assistecircncia Teacutecnica Tel (+351) 214 266 505 Dep Com Bombas [SIHI Busch] Tel (+351) 214 266 508 Fax (+351) 214 266 506

8

service and maintenance procedures is controlled using pre-defined access levels and passwordspreventing unauthorized access

Each cycle is adjustable to meet specific processing requirements All user-accessible control functionscan be changed using the touch screen control Cycle parameters are retained in control memory forrepeated use Once cycle is started cycles and cycle values cannot be changed until cycle is

complete The system features a comprehensive alarmalert system with automatic triggering of pre-programmable information alerts The self-diagnostic program monitors the sterilizer performanceautomatically and process check-up and failure corrections

In case of a malfunction during the sterilization cycle the process enters in an emergency alarm phasewhich safely will end the process automatically

Alarm range includes

bull Temperature pressure sensor and analogue input failure

bull Power failure

bull Door(s) failure

bull Gasket and chamber sealing failure

bull Phase Timeout

bull Doors safety interlock failure

bull Water supply failure

bull Steam failure

bull Compressed air failure

bull Vacuum Pump failure

bull Microcomputer failure

The bar Graph screen displays the chamber temperature and pressure as a bar graph and also showsa digital time representing the time remaining in the cycle The Plot Graph screen displays the chambertemperature and pressure as a trend curve using a graphic display

A process data record printer and a graphic recorder (as OPTIONAL) are mounted at the non -sterileside to record all relevant process information like program cycle steps time temperature pressuredate cycle start time both sterilizer and daily cycle number total cycle count fault conditions userverification and signature and load information

Data is automatically printed at the beginning and at the end of each cycle with all transition pointrsquosinformation and summary verification of time at selected temperaturepressure (minmax values)performed during cycle operation

The microcomputer stores the cycle data and in case of printer failure during the cycle or on demandthe user can reprint the last cycle

As buyerrsquos option the steam sterilizer can be equipped with a load temperature probe inside thesterilization chamber and perform sterilization based F0 control The control system allows control ofliquid sterilization by F0 value rather than time and temperature This mode of control may optionally beused for heat sensitive liquids

Before operating the sterilizer it is important to become familiar with the location and function of allmajor components and controls

As OPTIONAL the record system can be mounted on the ldquosterile siderdquo

8162019 Specifications Amaro 5000 amp Steri 21 MD009_04 en a J COSTA (IRMAtildeOS) LDA Desde 1953 Ao Serviccedilo Meacutedico-Hhellip

httpslidepdfcomreaderfullspecifications-amaro-5000-steri-21-md00904-en-a-j-costa-irmaos-lda 910

983117983108983088983088983097983087983088983092 983109983118

A J COSTA (IRMAtildeOS) LDA ndash Desde 1953 ao Serviccedilo Meacutedico-Hospitalar

Estrada das Ligeiras Lote 10 Alto da Bela Vista 2735-337 Caceacutem Portugal E-mail infoajcostairmaoscom URLwwwajcostairmaoscom

Geral Tel (+351) 214 266 500 Fax (+351) 214 262 421 Dep Com [Eliwell Jumo Wika] Tel (+351) 214 266 502 Fax (+351) 214 266 507

Assistecircncia Teacutecnica Tel (+351) 214 266 505 Dep Com Bombas [SIHI Busch] Tel (+351) 214 266 508 Fax (+351) 214 266 506

9

The steam sterilizer has an automatic shutdown system If no operation is performed after anadjustable time it will go into an energy conservation mode Sterilizer utilities can be restarted as soonthe user starts or selects a new cycle

129 Temperature and Pressure Sensors and Gauges

The system is equipped with up to four temperature sensors two absolute pressure transducers fourpressure gauges and safety devices having the following functions

The temperature sensors

In the drain ndash control of heat exchanger drain and liquid ring vacuum pump watertemperature

In the chamber condensate line (double independent PT100 probe) ndash controlmonitoring and printout of sterilization process temperature

Inside the chamber (flexible PT100 probe as OPTIONAL for liquids) ndash controlmonitoring and printout of load sterilization process temperature

The absolute pressure transducers

Chamber pressure ndash control display monitoring and printout

Jacket pressure ndash control display monitoring and printout

The pressure gauges (front panel as OPTIONAL)

Front Panel

Steam source pressure (built-in steam generator or building steam supply)

Chamber pressure

Jacket pressure

Service Area

Steam source pressure (built-in steam generator andor building steam supply)

The safety devices

Pressure Safety Valves

Built-in steam generator certified pre-set pressure calibrated for 34 bar gauge

Chamber certified pre-set pressure calibrated for 24 bar gauge

Jacket certified pre-set pressure calibrated for 26 bar gauge

Door(s) end switch

Open and close position prevents the inlet of steam pressure to the chamber andto the door gasket if the door is not closed

Door(s) safety lock

Safety lock mechanism with proper device for manual operation preventing theopening of in case of power failure preventing the door from opening in case ofelectrical power or compressed air failure

Door(s) sensor safety

Two sensors for safety guard system on each door which automatically stopsand reverses the door(s) motion if any obstruction is detected along the entire

path of travel preventing the door from trapping any object while closingEmergency Stop push-buttons

8162019 Specifications Amaro 5000 amp Steri 21 MD009_04 en a J COSTA (IRMAtildeOS) LDA Desde 1953 Ao Serviccedilo Meacutedico-Hhellip

httpslidepdfcomreaderfullspecifications-amaro-5000-steri-21-md00904-en-a-j-costa-irmaos-lda 1010

983117983108983088983088983097983087983088983092 983109983118

A J COSTA (IRMAtildeOS) LDA ndash Desde 1953 ao Serviccedilo Meacutedico-Hospitalar

Estrada das Ligeiras Lote 10 Alto da Bela Vista 2735-337 Caceacutem Portugal E-mail infoajcostairmaoscom URLwwwajcostairmaoscom

Geral Tel (+351) 214 266 500 Fax (+351) 214 262 421 Dep Com [Eliwell Jumo Wika] Tel (+351) 214 266 502 Fax (+351) 214 266 507

10

Mounted on both the unsterile and sterile panel This feature is designed toprevent human hazards accidents or equipment breakdown in compliance withthe European Standards EN-285 requirements

13 Standards

A J Costa (Irmatildeos) Lda meets the provisions of the Medical Device Directive 9342EEC and PED9723EEC and the following standards

EN 2852006 - Sterilization - Steam sterilizers - Large sterilizers

ISO 17665-12006 ndash Sterilization of health care products - Moist heat - Part 1 Requirements forthe development validation and routine control of a sterilization process for medical devices

ASME Section VIII Division I for unfired pressure vessels - ASME Boiler and pressurevessel code

IEC 61010-2-0402005 ndash Safety requirements for electrical equipment for measurement controland laboratory use ndash Part 2 ndash 040 Particular requirements for sterilizers and washer-disinfectorsused to treat medical materials

IEC 61326-12005 ndash Electrical equipment for measurement control and laboratory use ndash EMCrequirements ndash Part 1 General requirements

A J Costa (Irmatildeos) Lda is also approved for

ISO 9001 (Quality Management Systems)

ISO 13485 (Medical devices mdash Quality management systems ndash Requirements for regulatorypurposes )

Page 8: Specifications. Amaro 5000 & Steri 21 MD009_04 en. a. J. COSTA (IRMÃOS), LDA. Desde 1953 Ao Serviço Médico-Hospitalar

8162019 Specifications Amaro 5000 amp Steri 21 MD009_04 en a J COSTA (IRMAtildeOS) LDA Desde 1953 Ao Serviccedilo Meacutedico-Hhellip

httpslidepdfcomreaderfullspecifications-amaro-5000-steri-21-md00904-en-a-j-costa-irmaos-lda 810

983117983108983088983088983097983087983088983092 983109983118

A J COSTA (IRMAtildeOS) LDA ndash Desde 1953 ao Serviccedilo Meacutedico-Hospitalar

Estrada das Ligeiras Lote 10 Alto da Bela Vista 2735-337 Caceacutem Portugal E-mail infoajcostairmaoscom URLwwwajcostairmaoscom

Geral Tel (+351) 214 266 500 Fax (+351) 214 262 421 Dep Com [Eliwell Jumo Wika] Tel (+351) 214 266 502 Fax (+351) 214 266 507

Assistecircncia Teacutecnica Tel (+351) 214 266 505 Dep Com Bombas [SIHI Busch] Tel (+351) 214 266 508 Fax (+351) 214 266 506

8

service and maintenance procedures is controlled using pre-defined access levels and passwordspreventing unauthorized access

Each cycle is adjustable to meet specific processing requirements All user-accessible control functionscan be changed using the touch screen control Cycle parameters are retained in control memory forrepeated use Once cycle is started cycles and cycle values cannot be changed until cycle is

complete The system features a comprehensive alarmalert system with automatic triggering of pre-programmable information alerts The self-diagnostic program monitors the sterilizer performanceautomatically and process check-up and failure corrections

In case of a malfunction during the sterilization cycle the process enters in an emergency alarm phasewhich safely will end the process automatically

Alarm range includes

bull Temperature pressure sensor and analogue input failure

bull Power failure

bull Door(s) failure

bull Gasket and chamber sealing failure

bull Phase Timeout

bull Doors safety interlock failure

bull Water supply failure

bull Steam failure

bull Compressed air failure

bull Vacuum Pump failure

bull Microcomputer failure

The bar Graph screen displays the chamber temperature and pressure as a bar graph and also showsa digital time representing the time remaining in the cycle The Plot Graph screen displays the chambertemperature and pressure as a trend curve using a graphic display

A process data record printer and a graphic recorder (as OPTIONAL) are mounted at the non -sterileside to record all relevant process information like program cycle steps time temperature pressuredate cycle start time both sterilizer and daily cycle number total cycle count fault conditions userverification and signature and load information

Data is automatically printed at the beginning and at the end of each cycle with all transition pointrsquosinformation and summary verification of time at selected temperaturepressure (minmax values)performed during cycle operation

The microcomputer stores the cycle data and in case of printer failure during the cycle or on demandthe user can reprint the last cycle

As buyerrsquos option the steam sterilizer can be equipped with a load temperature probe inside thesterilization chamber and perform sterilization based F0 control The control system allows control ofliquid sterilization by F0 value rather than time and temperature This mode of control may optionally beused for heat sensitive liquids

Before operating the sterilizer it is important to become familiar with the location and function of allmajor components and controls

As OPTIONAL the record system can be mounted on the ldquosterile siderdquo

8162019 Specifications Amaro 5000 amp Steri 21 MD009_04 en a J COSTA (IRMAtildeOS) LDA Desde 1953 Ao Serviccedilo Meacutedico-Hhellip

httpslidepdfcomreaderfullspecifications-amaro-5000-steri-21-md00904-en-a-j-costa-irmaos-lda 910

983117983108983088983088983097983087983088983092 983109983118

A J COSTA (IRMAtildeOS) LDA ndash Desde 1953 ao Serviccedilo Meacutedico-Hospitalar

Estrada das Ligeiras Lote 10 Alto da Bela Vista 2735-337 Caceacutem Portugal E-mail infoajcostairmaoscom URLwwwajcostairmaoscom

Geral Tel (+351) 214 266 500 Fax (+351) 214 262 421 Dep Com [Eliwell Jumo Wika] Tel (+351) 214 266 502 Fax (+351) 214 266 507

Assistecircncia Teacutecnica Tel (+351) 214 266 505 Dep Com Bombas [SIHI Busch] Tel (+351) 214 266 508 Fax (+351) 214 266 506

9

The steam sterilizer has an automatic shutdown system If no operation is performed after anadjustable time it will go into an energy conservation mode Sterilizer utilities can be restarted as soonthe user starts or selects a new cycle

129 Temperature and Pressure Sensors and Gauges

The system is equipped with up to four temperature sensors two absolute pressure transducers fourpressure gauges and safety devices having the following functions

The temperature sensors

In the drain ndash control of heat exchanger drain and liquid ring vacuum pump watertemperature

In the chamber condensate line (double independent PT100 probe) ndash controlmonitoring and printout of sterilization process temperature

Inside the chamber (flexible PT100 probe as OPTIONAL for liquids) ndash controlmonitoring and printout of load sterilization process temperature

The absolute pressure transducers

Chamber pressure ndash control display monitoring and printout

Jacket pressure ndash control display monitoring and printout

The pressure gauges (front panel as OPTIONAL)

Front Panel

Steam source pressure (built-in steam generator or building steam supply)

Chamber pressure

Jacket pressure

Service Area

Steam source pressure (built-in steam generator andor building steam supply)

The safety devices

Pressure Safety Valves

Built-in steam generator certified pre-set pressure calibrated for 34 bar gauge

Chamber certified pre-set pressure calibrated for 24 bar gauge

Jacket certified pre-set pressure calibrated for 26 bar gauge

Door(s) end switch

Open and close position prevents the inlet of steam pressure to the chamber andto the door gasket if the door is not closed

Door(s) safety lock

Safety lock mechanism with proper device for manual operation preventing theopening of in case of power failure preventing the door from opening in case ofelectrical power or compressed air failure

Door(s) sensor safety

Two sensors for safety guard system on each door which automatically stopsand reverses the door(s) motion if any obstruction is detected along the entire

path of travel preventing the door from trapping any object while closingEmergency Stop push-buttons

8162019 Specifications Amaro 5000 amp Steri 21 MD009_04 en a J COSTA (IRMAtildeOS) LDA Desde 1953 Ao Serviccedilo Meacutedico-Hhellip

httpslidepdfcomreaderfullspecifications-amaro-5000-steri-21-md00904-en-a-j-costa-irmaos-lda 1010

983117983108983088983088983097983087983088983092 983109983118

A J COSTA (IRMAtildeOS) LDA ndash Desde 1953 ao Serviccedilo Meacutedico-Hospitalar

Estrada das Ligeiras Lote 10 Alto da Bela Vista 2735-337 Caceacutem Portugal E-mail infoajcostairmaoscom URLwwwajcostairmaoscom

Geral Tel (+351) 214 266 500 Fax (+351) 214 262 421 Dep Com [Eliwell Jumo Wika] Tel (+351) 214 266 502 Fax (+351) 214 266 507

10

Mounted on both the unsterile and sterile panel This feature is designed toprevent human hazards accidents or equipment breakdown in compliance withthe European Standards EN-285 requirements

13 Standards

A J Costa (Irmatildeos) Lda meets the provisions of the Medical Device Directive 9342EEC and PED9723EEC and the following standards

EN 2852006 - Sterilization - Steam sterilizers - Large sterilizers

ISO 17665-12006 ndash Sterilization of health care products - Moist heat - Part 1 Requirements forthe development validation and routine control of a sterilization process for medical devices

ASME Section VIII Division I for unfired pressure vessels - ASME Boiler and pressurevessel code

IEC 61010-2-0402005 ndash Safety requirements for electrical equipment for measurement controland laboratory use ndash Part 2 ndash 040 Particular requirements for sterilizers and washer-disinfectorsused to treat medical materials

IEC 61326-12005 ndash Electrical equipment for measurement control and laboratory use ndash EMCrequirements ndash Part 1 General requirements

A J Costa (Irmatildeos) Lda is also approved for

ISO 9001 (Quality Management Systems)

ISO 13485 (Medical devices mdash Quality management systems ndash Requirements for regulatorypurposes )

Page 9: Specifications. Amaro 5000 & Steri 21 MD009_04 en. a. J. COSTA (IRMÃOS), LDA. Desde 1953 Ao Serviço Médico-Hospitalar

8162019 Specifications Amaro 5000 amp Steri 21 MD009_04 en a J COSTA (IRMAtildeOS) LDA Desde 1953 Ao Serviccedilo Meacutedico-Hhellip

httpslidepdfcomreaderfullspecifications-amaro-5000-steri-21-md00904-en-a-j-costa-irmaos-lda 910

983117983108983088983088983097983087983088983092 983109983118

A J COSTA (IRMAtildeOS) LDA ndash Desde 1953 ao Serviccedilo Meacutedico-Hospitalar

Estrada das Ligeiras Lote 10 Alto da Bela Vista 2735-337 Caceacutem Portugal E-mail infoajcostairmaoscom URLwwwajcostairmaoscom

Geral Tel (+351) 214 266 500 Fax (+351) 214 262 421 Dep Com [Eliwell Jumo Wika] Tel (+351) 214 266 502 Fax (+351) 214 266 507

Assistecircncia Teacutecnica Tel (+351) 214 266 505 Dep Com Bombas [SIHI Busch] Tel (+351) 214 266 508 Fax (+351) 214 266 506

9

The steam sterilizer has an automatic shutdown system If no operation is performed after anadjustable time it will go into an energy conservation mode Sterilizer utilities can be restarted as soonthe user starts or selects a new cycle

129 Temperature and Pressure Sensors and Gauges

The system is equipped with up to four temperature sensors two absolute pressure transducers fourpressure gauges and safety devices having the following functions

The temperature sensors

In the drain ndash control of heat exchanger drain and liquid ring vacuum pump watertemperature

In the chamber condensate line (double independent PT100 probe) ndash controlmonitoring and printout of sterilization process temperature

Inside the chamber (flexible PT100 probe as OPTIONAL for liquids) ndash controlmonitoring and printout of load sterilization process temperature

The absolute pressure transducers

Chamber pressure ndash control display monitoring and printout

Jacket pressure ndash control display monitoring and printout

The pressure gauges (front panel as OPTIONAL)

Front Panel

Steam source pressure (built-in steam generator or building steam supply)

Chamber pressure

Jacket pressure

Service Area

Steam source pressure (built-in steam generator andor building steam supply)

The safety devices

Pressure Safety Valves

Built-in steam generator certified pre-set pressure calibrated for 34 bar gauge

Chamber certified pre-set pressure calibrated for 24 bar gauge

Jacket certified pre-set pressure calibrated for 26 bar gauge

Door(s) end switch

Open and close position prevents the inlet of steam pressure to the chamber andto the door gasket if the door is not closed

Door(s) safety lock

Safety lock mechanism with proper device for manual operation preventing theopening of in case of power failure preventing the door from opening in case ofelectrical power or compressed air failure

Door(s) sensor safety

Two sensors for safety guard system on each door which automatically stopsand reverses the door(s) motion if any obstruction is detected along the entire

path of travel preventing the door from trapping any object while closingEmergency Stop push-buttons

8162019 Specifications Amaro 5000 amp Steri 21 MD009_04 en a J COSTA (IRMAtildeOS) LDA Desde 1953 Ao Serviccedilo Meacutedico-Hhellip

httpslidepdfcomreaderfullspecifications-amaro-5000-steri-21-md00904-en-a-j-costa-irmaos-lda 1010

983117983108983088983088983097983087983088983092 983109983118

A J COSTA (IRMAtildeOS) LDA ndash Desde 1953 ao Serviccedilo Meacutedico-Hospitalar

Estrada das Ligeiras Lote 10 Alto da Bela Vista 2735-337 Caceacutem Portugal E-mail infoajcostairmaoscom URLwwwajcostairmaoscom

Geral Tel (+351) 214 266 500 Fax (+351) 214 262 421 Dep Com [Eliwell Jumo Wika] Tel (+351) 214 266 502 Fax (+351) 214 266 507

10

Mounted on both the unsterile and sterile panel This feature is designed toprevent human hazards accidents or equipment breakdown in compliance withthe European Standards EN-285 requirements

13 Standards

A J Costa (Irmatildeos) Lda meets the provisions of the Medical Device Directive 9342EEC and PED9723EEC and the following standards

EN 2852006 - Sterilization - Steam sterilizers - Large sterilizers

ISO 17665-12006 ndash Sterilization of health care products - Moist heat - Part 1 Requirements forthe development validation and routine control of a sterilization process for medical devices

ASME Section VIII Division I for unfired pressure vessels - ASME Boiler and pressurevessel code

IEC 61010-2-0402005 ndash Safety requirements for electrical equipment for measurement controland laboratory use ndash Part 2 ndash 040 Particular requirements for sterilizers and washer-disinfectorsused to treat medical materials

IEC 61326-12005 ndash Electrical equipment for measurement control and laboratory use ndash EMCrequirements ndash Part 1 General requirements

A J Costa (Irmatildeos) Lda is also approved for

ISO 9001 (Quality Management Systems)

ISO 13485 (Medical devices mdash Quality management systems ndash Requirements for regulatorypurposes )

Page 10: Specifications. Amaro 5000 & Steri 21 MD009_04 en. a. J. COSTA (IRMÃOS), LDA. Desde 1953 Ao Serviço Médico-Hospitalar

8162019 Specifications Amaro 5000 amp Steri 21 MD009_04 en a J COSTA (IRMAtildeOS) LDA Desde 1953 Ao Serviccedilo Meacutedico-Hhellip

httpslidepdfcomreaderfullspecifications-amaro-5000-steri-21-md00904-en-a-j-costa-irmaos-lda 1010

983117983108983088983088983097983087983088983092 983109983118

A J COSTA (IRMAtildeOS) LDA ndash Desde 1953 ao Serviccedilo Meacutedico-Hospitalar

Estrada das Ligeiras Lote 10 Alto da Bela Vista 2735-337 Caceacutem Portugal E-mail infoajcostairmaoscom URLwwwajcostairmaoscom

Geral Tel (+351) 214 266 500 Fax (+351) 214 262 421 Dep Com [Eliwell Jumo Wika] Tel (+351) 214 266 502 Fax (+351) 214 266 507

10

Mounted on both the unsterile and sterile panel This feature is designed toprevent human hazards accidents or equipment breakdown in compliance withthe European Standards EN-285 requirements

13 Standards

A J Costa (Irmatildeos) Lda meets the provisions of the Medical Device Directive 9342EEC and PED9723EEC and the following standards

EN 2852006 - Sterilization - Steam sterilizers - Large sterilizers

ISO 17665-12006 ndash Sterilization of health care products - Moist heat - Part 1 Requirements forthe development validation and routine control of a sterilization process for medical devices

ASME Section VIII Division I for unfired pressure vessels - ASME Boiler and pressurevessel code

IEC 61010-2-0402005 ndash Safety requirements for electrical equipment for measurement controland laboratory use ndash Part 2 ndash 040 Particular requirements for sterilizers and washer-disinfectorsused to treat medical materials

IEC 61326-12005 ndash Electrical equipment for measurement control and laboratory use ndash EMCrequirements ndash Part 1 General requirements

A J Costa (Irmatildeos) Lda is also approved for

ISO 9001 (Quality Management Systems)

ISO 13485 (Medical devices mdash Quality management systems ndash Requirements for regulatorypurposes )