EURO

STEA

MSa

ture

d S

tea

m S

teri

lize

rM

ed

ica

l D

evi

ce

2

Compact dimensions, Versat i l i ty and Rapidi ty

Model 2.150 VSD Model 4.300 VSDModel 4.450 VSD Model 4.600 VSD

Ser ies 2 and 4 withvert ical s l id ing doors

The Eurosteam line is a series of new generation steam sterilisers, the result of the most advanced project design de-veloped by Angelantoni Life Science, a leading company in Infection Control.

Their advanced technology, creativeness, design and company know-how, gained in decades of business in the bio-medical sector, have enabled them to develop equipment based on the concept of Total Quality, capable of satisfying the needs of a market, which requires a total guarantee of safety, reliability and repeatability of the sterilisation pro-cesses.

Total Quality to manufacture Medical Devices with high standards of construction, using advanced technologies and innovative solutions for an eco-sustainable project providing water and energy consumption and thermal dissipation close to zero.

Technology

3

E rgonimic loading H igh performance

Model 4.300 HSDModel 4.450 HSD Model 4.600 HSD

Model 6.500 HSDModel 6.700 HSDModel 6.900 HSDModel 6.1200 HSD

Ser ies 2 and 4 withvert ical s l id ing doors

+50%Useful life

Ser ies 4 and 6 with hor izontal s l id ing doors

The Eurosteam line was designed to last over time. The generous size, ample safety factors and innovative, robust con-struction of the structures provide a top performance, which doubles that of any equipment currently on the market.

The parts used are manufactured by leading European companies, which guarantee the availability of parts over time and their interchangeability with future models.

With its current market set-up, Angelantoni Life Science is moving against the market trend and aims, in the short term, to replace any equipment and parts with a significant environmental impact.

Useful Life

4

Mass production was developed during the design stage, by studying the position of the components and the main functional units to simplify the production stages.

The repeatability of the pre-assembly and installation op-erations guarantees a reduction in production times and costs, which facilitates the industrialisation of the produc-tion process to achieve an end product with high qualita-tive standards.

CSSD: loading side

IndustrializationThe validation operations make sure the design condi-tions are complied with after installation.

More specifically, during the sterilisation cycle the fol-lowing values are checked continually: pressure, tem-perature and non-condensable gases.

The monitored parameters guarantee not only the ef-fectiveness of the sterilisation process in compliance with the reference standard UNI EN ISO 17665-1:2006, but also a Sterility Assurance Level (SAL) of 10-6.

Validation

4

SinergyKnow-how

Ability

Customer support

Experience

4

5

CSSD: unloading side

55

Water saving 95%, with reference to 8 cycles/day + 2 test cycles/day, based on water consumption of traditional autoclave 600 liters capacity (8STU).The only consumption is related to the osmotic water used to generate steam 5%(20 liters).

CYCLE

YEAR

liters

each equipment

each equipment

installed

installed

per cycle for

per year for

500

1.300.000

saved

liters saved

6

The Eurosteam line was studied by applying the concept of an eco-project design, with the objective of preserving the environment in which we live. Pollutant emissions have been considerably reduced throughout the machine’s entire life cycle by introducing innovative technical solutions and top quality components.

Starting from the idea of producing a piece of equipment with sustainable consumption to reduce the environmental impact, significant measurable objectives were set and achieved, all of which enhance the performance achieved by the Eurosteam line.

Enviromental impact

100%Recyclable

-95%Water

consumption

-40%Energy

consumption

Water consumption

95% compared to similar equipment. A dry-operating, mechanical, steam-compatible, vacuum pump generates the vacuum. Water consumption to generate the vacuum is equal to zero. 5% of consumption regards the osmotic water used to generate the steam.

Energy consumption

-40% compared to similar equipment. The objective of reducing energy consumption is linked to thermal dissipation and energy recovery.The use of innovative technical solutions and excellent insulating materials gives excel-lent results for the thermal insulation of the generator, the sterilisation chamber, the doors and the hydraulic system. The device to pre-heat and degas the water (optional) is an additional system to reco-ver energy. The condensate in the cavity wall is reused to preheat the water for the generator. The high temperature reached enables degassing (elimination of the non-condensable gases) and reduces the variations in temperature inside the generator during intake.

Recyclable

80% of the equipment is constructed of stainless steel and can, therefore, be com-pletely recyclable. The remaining 20% of the components are recyclable according to their individual procedures.

Angelantoni Life Science is known to constantly strive for improved efficiency, effectiveness in its production, with projects focusing on Saving, Safety and Total Quality.Saving in operational and maintenance costs is one of the main objectives of its project design, and the Eurosteam line proposes top quality, reliable, long-lasting solutions and components.

Saving

7

A top performance, mechanical vacuum pump drastically reduces the time taken to create the vacuum.

Two opposed inlets for steam intake into the chamber improve steam diffusion and facilitate air emission.

The generator power and steam reserve enable the chamber pressure and temperature to rise rapidly.

The proportionately sized vacuum and steam circuits facilitate fluid flow.

The technical solutions offered by the Eurosteam line provide quicker sterilisa-tion cycles compared to those of similar equipment. A detailed design of the systems and careful choice of components influences the running of the sterilisation cycles and enables times to be speeded up and production capacity to be increased.

More specifically: -40%Energy

consumption

sterilization cycle 134°C for textiles sterilization cycle 121° for rubber sterilization cycle 134° for surgical instruments sterilization cycle 134° for prions steam penetration test cycle (Bowie&Dick Test) automatic and electronic steam penetration test cycle according to EN 285 (optional-B&D automatic/electronic) vacuum seal test cycle open cycle: is possible to program 100 new cycles short cycle 134°C (to be validated with the type of load)

Sterilization cycles

1.2.3.4.5.6.

7.8.9.

The Eurosteam line is configured with the following cycles:

-25%Cycle time

Quick cycle

Pressure

Temperature

8

A Central sterile services department envisages specific procedures, flows of material and pathways for the health personnel, with mandatory traceability checks, which must be complied with to consider the “re-processing”of dirty instruments and their storage as clean and sterile.

Material is separated into different dedicated areas, which must be protected by major access restrictions and con-struction solutions in order to keep sections separate, so they cannot be polluted.

Angelantoni Life Science has introduced a physical barrier inside the sterilisers, passing between the clean area and the sterile area to prevent the risk of contamination.

The Bioseal guarantees the sections are completely sepa-rate. The internal barrier consists of an AISI 304 stainless steel structure, aligned with the wall and sealed, to ensure the pressure difference between the two areas is main-tained.

Bioseal

Directives, certificates and construction standardsThe Eurosteam line are Medical Device with an identification number issued by the notified body and CE marked in accordance with the Eu-ropean Directive 93/42/EEC.They are designed and realized respecting the latest European and in-ternational standards: • 2006/42/EC for Machinery Directive• 2014/68/EU for Pressure Equipment (PED)• 2009/125/EC for Eco-friendly design (ERP)• 2014/35/EU for Low voltage• 2014/30/EU for Electromagnetic compatibility• UNI EN ISO 285:2016 (specific requirements and tests for large steam sterilizers)• UNI EN ISO 17665-1:2016 (specific development, validation and routine testing)• CEI EN ISO 61010-1:2013 (safety requirements for electronic equipment)• CEI EN ISO 61010-2-040:2015 (specific requirements for sterilizers and washer-disinfectors used for the treatment of medical materials)• UNI EN ISO 15614-1:2012 (qualification of welding procedures)• UNI EN ISO 9606-1:2013 (welder qualification test)• UNI CEI EN ISO 17050-1:2005 (conformity assessment)• UNI EN ISO 14971-1:2012 (risk analysis for MD)• EN IEC 62304:2006 (software validation)• IEC 62366-1:2015 (MD usability)• UNI EN ISO 9001:2015 (quality management system)• UNI EN ISO 13485:2012 (quality management system for MD)

Luogo e Data/Place and date: Vimercate (MB), 08 giugno 2016

Per l'Organismo di Certificazione/ For the Certification Body

Vittore Marangon

Management Representative

La validità del presente Certificato è subordinata al rispetto delle condizioni contenute nel Contratto di Certificazione/ Lack of fulfilment of conditions as set out in the Certification Agreement may render this Certificate invalid. DNV GL Business Assurance Italia S.r.l. Via Energy Park, 14, 20871 Vimercate (MB), Italy. Tel: 039 68 99 905. www.dnvgl.it/assurance

MANAGEMENT SYSTEM CERTIFICATE

Certificato No./Certificate No.: 194648-2016-AQ-ITA-ACCREDIA

Data prima emissione/Initial date: 28 gennaio 2016

Validità/Valid: 28 gennaio 2016 - 28 gennaio 2019

Si certifica che il sistema di gestione di/This is to certify that the management system of

ANGELANTONI LIFE SCIENCE S.r.l. Località Cimacolle, 464 - 06056 Massa Martana (PG) - Italy È conforme ai requisiti della norma per il Sistema di Gestione/ Has been found to conform to the Management System standard: UNI CEI EN ISO 13485:2012 (ISO 13485:2003) Questa certificazione è valida This certificate is valid per il seguente campo applicativo: for the following scope: Progettazione, produzione, vendita e assistenza tecnica di emoteche e congelatori per la conservazione di plasma ed emoderivati, congelatori rapidi

per plasma, apparecchiature frigorifere per conservazione di tessuti biologici e sterilizzatrici a vapore e sistemi di lavaggio e disinfezione ad uso medicale

Design, manufacture, sale and technical service of blood bank refrigerators and plasma freezers, plasma shock freezers, biological tissues

cooling units ,steam sterilizers and washers and disinfectors devices for medical use

9

Main technical featuresFrame, front and side panels in stainless steel AISI 304Sterilization chamber in stainless steel AISI 316Ti, thickness 8mmCollecting chamber bottom and central filtering, easy to clean and fully drainableJacket in stainless steel AISI 316Ti, thickness 5mmJacket covers totally the sterilization chamber, ensuring better performance and uniformity.Door/s in stainless steel AISI 316Ti, thickness 30mmInternal chamber and door/s mirrored finishingAutomatic sliding device for vertical and horizontal door/sDoor/s sealing by dynamic ”air chamber” gasketChamber and steam generator isolated with fire retardant mattress, covered with panels in stainless steel AISI 304Condensation and steam line totally isolated with silicon material and fibers of KevlarHydraulic pipes and pneumatic valves in stainless steel AISI 316Bioseal: internal barrier consists of an AISI 304 stainless steel structure, aligned with the wall and sealed,ensuring a total separation between clean side and sterile sideElectrical steam generator in stainless steel AISI 304 (E)Internal steam exchanger in stainless steel AISI 304 (SE)Centralized steam directly to the chamber (S)Electrical steam generator and Central steam (ES)Mechanical dry vacuum pumpDouble data process system (2 probes for temperature and 2 for pressure transducers)PLC Siemens (certified MD)Touch screen Siemens (7 or 9 inches) full colour and high resolutionAlphanumeric recording device installed on the front panelUSB connection for data backupFront access for routine maintenance, with telescopic electronic panel and IP protectionAbility to operate in accordance with 21 CFR Part 11 FDA

Possibility to connect the equipment to a traceability systemDisconnection water devicePreheating device and water degassing systemAir-check steam control device (quality system)Discharge cooling deviceRemote maintenance control deviceBowie&Dick electronic/automaticSecond touch-screen Siemens on the unloading sideSteam filter system deviceLiquid cycle with natural cooling device

1.2.3.4.5.6.7.8.9.

10.11.12.13.

14.15.16.17.18.19.20.21.22.23.24.25.

26.27.28.29.30.31.32.33.34.35.

Optionals

27

28

32

29

30

3435

33

31

10

Definition of model code:

● Eurosteam Line: Satured steam autoclave

● Medical Device “MD”: Hospital application

● Steam “STM”: Sterilization agent

● Series – “2/4/6”: load capacity in STU (dimensions 300x300 mm)

● Volume – “from 158 to 1108 lt”: Capacity in liters

● Number of doors – “1 or 2”

● Doors movement – “HSD”: Horizontal automatic sliding door/s

● Doors movement – “VSD”: Vertical automatic sliding door/s

● Operation E: Electrical internal steam generator S: Centralized steam connection ES: Electrical steam generator and centralized steam connection SE: Internal steam exchanger

Range of EUROSTEAM

VSD series vertical sliding doors

Series Model Capacity (lt) STU Chamber dimensions (WxHxD mm) Overall dimensions (WxHxD mm)

2 MD.STM.2.150.1/2VSD.E/S/ES/SE 158 2 330x680x700 1020x1860x8904 MD.STM.4.300.1/2VSD.E/S/ES/SE 315 4 660x680x700 1400x1860x8904 MD.STM.4.450.1/2VSD.E/S/ES/SE 449 6 660x680x1000 1400x1860x11904 MD.STM.4.600.1/2VSD.E/S/ES/SE 584 8 660x680x1300 1400x1860x1490

It is possible to require different sizes of sterilization chamber, not more than +/-10% of the size of the chamber (EN 285:2006+A2:2009 Annex F.2-Criteria for identifying sterilizers of the same type)

HSD series horizontal sliding doors

Series Model Capacity (lt) STU Chamber dimensions (WxHxD mm) Overall dimensions (WxHxD mm)

4 MD.STM.4.300.1/2HSD.E/S/ES/SE 315 4 660x680x700 1650x1850x9704 MD.STM.4.450.1/2HSD.E/S/ES/SE 449 6 660x680x1000 1650x1850x12704 MD.STM.4.600.1/2HSD.E/S/ES/SE 584 8 660x680x1300 1650x1850x15706 MD.STM.6.500.1/2HSD.E/S/ES/SE 485 6 660x1050x700 1650x1850x9706 MD.STM.6.700.1/2HSD.E/S/ES/SE 693 9 660x1050x1000 1650x1850x12706 MD.STM.6.900.1/2HSD.E/S/ES/SE 901 12 660x1050x1300 1650x1850x15706 MD.STM.6.1200.1/2HSD.E/S/ES/SE 1108 15 660x1050x1600 1650x1850x1870

Example Model MD.STM.4.600.2VSD.E

Medical DeviceSteam8 STU600 liters2 Automatic vertical sliding doorsElectrical internal steam generator

Example Model MD.STM.6.500.2HSD.ES

Medical DeviceSteam6 STU500 liters2 Automatic horizontal sliding doorsElectrical steam generator and centralized steam connection

11

1 STU sterilization basket

Definition of model code:

● Eurosteam Line: Satured steam autoclave

● Medical Device “MD”: Hospital application

● Steam “STM”: Sterilization agent

● Series – “2/4/6”: load capacity in STU (dimensions 300x300 mm)

● Volume – “from 158 to 1108 lt”: Capacity in liters

● Number of doors – “1 or 2”

● Doors movement – “HSD”: Horizontal automatic sliding door/s

● Doors movement – “VSD”: Vertical automatic sliding door/s

● Operation E: Electrical internal steam generator S: Centralized steam connection ES: Electrical steam generator and centralized steam connection SE: Internal steam exchanger

External optionals

Internal trolleySeries 2.150 (2 STU)Serie 4 (4-6-8 STU)

Internal trolleySeries 6.500 (6 STU)Series 6.700 (9 STU)Series 6.900 (12 STU)Series 6.1200 (15 STU)

Base gridSeries 2-4

Automatic loadingdeviceSeries 2-4

Automatic loadingdeviceSeries 6

Automatic unloadingdeviceSeries 2-4

Automatic unloadingdeviceSeries 6

Base grid with shelfSeries 2-4

ISO sterilization basket

Fixed heightexternal trolleySeries 2-4

Fixed heightexternal trolleySeries 6

Adjustable heightexternal trolleySeries 2-4

Adjustable heightexternal trolleySeries 6

ALS is one of the worldwide leading manufacturers of biomedical refrigeration, non contamination and sterilization equipment constantly committed to innovation and to environmental or biological safety.

Research centres, hospitals, universities, chemical and pharmaceutical companies are ALS Customers: our company can satisfy any requirement of scientific refrigeration, infection Control (autoclaves) and microbiological safety through a wide range of standard and special products.

In this field we can offer now a complete range of equipment and services to meet the needs of sterilization (CSSD), disinfection stations (CSDD) and special applications BSL3 laboratories - BSL4 and treating infected wastes (Biohazard).

ALS can be an ideal partner in Science and Technology due to a wide range of products and to the market presence in more than 50 Countries with local Agents and Distributors.

ALS invests more than 5% of its turnover in research and development involving a multidisciplinary team of scientists that support clients with cutting-edge, standard and customized solutions in terms of quality, reliability and innovation.

ALS is a subholding of Angelantoni Industrie Group established in 1932, worldwide known for innova-tion, R&D and high tech (19 active patents) such as climatic chambers and space simulators (Ange-lantoni Test Technologies), spattering machines for thin film technology (Kenosistec), solar receiver tubes for concentrated solar power plants ( Archimede Solar Energy) refrigeration turbo devices for energy saving (Turboalgor) in addition to ALS advanced and patented products such as Hemosafe, Smartfreezers and Waster.

Angelantoni Life Science

Copyright © Life Science 2016 Angelantoni s.r.l./Rev. 18/2017-illustrations, descriptions and technical data may change without notice.

Our skills and basic services for total customer satisfaction:

● Training, either at our premises a the customer’s premises

● Testing and quality control

● Process Validations (IQ-OQ-PQ)

● Design for Central of sterilization (CSSD) and central of disinfection (CSDD).

● Management of traceability and remote control of the equipment

● Certificate tools SIT Calibration

● Service contracts “full risk”

● Extended warranties

● Research and development

● Production and Assembly

● Installation and commissioning

● Preventive maintenance

● Market analysis and advice

● Special applications

ALS HeadquarterAngelantoni Life Science srl

Loc. Cimacolle 464,06056 Massa Martana (PG) - Italy

T. +39 075 89551 - F. +39 075 8955200info@angelantoni.it - www.angelantoni.it

ALS Milan BranchAngelantoni Life Science srl

viale Monza, 291 - 20126 Milano (MI)T. +39 02 939701 1 - F. +39 02 93970123info@angelantoni.it - www.angelantoni.it