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