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EUROSTEAM Satured Steam Sterilizer Medical Device

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EURO

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EUROPEAN INFECTION CONTROL

Series 1.80 VSDSeries 1.100 VSD

Series 2.150 VSD Series 2.200 VSDSeries 2.250 VSD

Versat i l i ty and rapidi ty

Series 2.220 VSD Series 4.300 VSDSeries 4.450 VSD Series 4.600 VSDSeries 4.700 VSDSeries 4.900 VSD

Compact dimensions

Ser ies 1, 2 and 4 withvert ical s l id ing doors

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The Eurosteam line has been designed to last in time.The generous sizing, the redundant safety factors and the innovative resistant architecture of the structures allow to obtain high performances in terms of duration and warranty, the double of what is currently offered on the market.Being the components integrated in the equipment supplied by Worldwide market leader companies, they are guaranteed over time as well as is guaranteed their interchangeability with future versionsThis is a concept in open contrast with the market trend in which, without taking in consideration the related ne-gative environmental impact, the idea of making busi-ness on the quick obsolescence usually prevails.

Versat i l i ty and rapidi ty

Ser ies 1, 2 and 4 withvert ical s l id ing doors

Service lifeTechnologyThe Eurosteam line is a series of new generation steam sterilzers, the result of the most advanced design made by Schlumbohm & Angelantoni Life Science, Leaders in the world of the Infection Control.German technology combined with Italian creativity and design, together with a Corporate Know-how ma-tured over decades of activity in the sector, led to the development of equipments based on the concept of “total quality”, able to satisfy the needs of an Elite mar-ket that requires a total safety assurance, absolute reli-ability and sterilization processes repeateable in time, without burdening the operators with the risk of failure.A total quality approach to produce medical devices with high construction standards, advanced techniques and innovative solutions.A total quality approach for an environmentally-friendly project with almost zero environmental impact, based on water saving and extremely low electricity consump-tion and heat dissipation.

+50%Service life

Series 4.300 HSDSeries 4.450 HSD Series 4.600 HSDSeries 4.700 HSD Series 4.900 HSD

Series 6.500 HSDSeries 6.700 HSDSeries 6.900 HSDSeries 6.1100 HSD

Ergonimic loading High performance

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

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EUROPEAN INFECTION CONTROL

The position of the components, the main functional units and the operational stages are designed to allow pre-assembling and facilitate the assembling in site, re-ducing significantly time and costs for a serial production.

The reduction of the stages and the repetition of the as-sembling operations, together with the optimisation of the semi-finished products, allow the Industrialization of the production process, ensuring at the same time a con-stant high quality standard of the finished product.

IndustrializationValidation is a key operation that allows the operator to assess, after installation, whether design conditions are respected.

The load is subjected to validation to guarantee that the values for pressure, temperature, time and non-condensable gases are performed as per correct pa-rameters, ensuring at the same time an efficient and effective process, fully compliant with the Standard UNI EN ISO 17665.

Validation

4

SinergyKnow-how

Ability

Customer support

Exerience

4

555

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

CYCLE

YEAR

liters

for each machine

for each machine

installed

installed

per cycle

per year

500

1.300.000

saved

liters saved

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EUROPEAN INFECTION CONTROL

The Eurosteam line has been developed by applying environmentally friendly design with the aim of preserving the en-vironment in which we live as much as possible, adopting innovative technical solutions and high quality components, in order to significantly reduce consumptions and, therefore, pollution during the entire life of the equipment.

Based on the idea of producing sustainable equipments, reducing environmental impact, we got significant and mea-surable objectives that enhance the Eurosteam line in view of the reached performances.

Enviromental impact

100%Recycling

-95%Water

consumption

-40%Energy

consumption

Water consumption

95% water saving compared to similar equipments. Vacuum generation takes place thanks to an innovative mechanical dry vacuum pump, completely compatible with the steam. Water consumption for generating vacuum is zero. Water consumption is only related to the steam production (5%)

Energy consumption

Energy consumption reduced of 40%. This objective is reached by the reduction of electricity consumption recovering energy and thermal dissipation. In fact, through a unique technical solution and through high performing insulating materials, the equip-ment obtain excellent results for thermal insulation of the generator, of the sterilization chamber, of doors and of the pipeline; these results lead to an overall reduction of heat emissions up to 30% compared to traditional applications in use. A further recovery is obtained by using the jacket condensate to pre-heat the generator water, bringing it to a temperature that supports degassing (elimination of non-condensable gases) and consequent reduction of temperature variations into the same generator during water injection.

A final contribution to reduce the electricity consumption is given by the regulation system of the pre-heated water re-use into the generator, introduced in such quanti-ties to avoid significant temperature variations.

Recycling

80% of the equipment is made of stainless steel, therefore fully recoverable; other components represent 20% of the equipment, and they are always recoverable and recyclable according to the procedures indicated by the manufacturers.

The constant research for increasing productivity and efficiency distinguishes and leads us to a design path aimed at “Safety”, “Total quality” and “Saving”.

“Saving” is one of the aims in which we focus at the design phase; saving in consumption and maintenance with high quality and reliability devices, solutions and components and long life of the equipments.

Saving

7

Dry mechanical vacuum pump, with high performances and extremely reduced time needed to create vacuum.

Steam injection into the chamber through two opposite inlets, with consequentimprovement of steam diffusion and easier air evacuation.

The generator power and the steam reserve allow pressure and temperature to rise quickly inside the chamber.

The appropriate size of the vacuum and steam pipeline circuit facilitates the passage of the fluids.

The Eurosteam line has a series of features that make the sterilization cycle quicker, compared to the standard steam sterilzers.

The extreme care for every single system, component and device intervening in the sterilization cycle and affecting the performance, makes each stage qui-cker and reduced in time, with a final increase in productivity. In particular:-40%

Energy consumption

sterilization cycle at 134°C for textiles sterilization cycle at 121° for rubber sterilization cycle at 134° for surgical instruments sterilization cycle at 134° for prions steam penetration test cycle (Bowie&Dick Test) automatic and electronic steam penetration test cycle according to EN 285 vacuum seal test cycle open cycle: possibility of programming 100 new cycles short cycle at 134°C (to validate with the used 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

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EUROPEAN INFECTION CONTROL

A modern concept of sterilization requires equipments, flows, paths, procedures, controls and full traceability in order to consider safe the “reprocessing” of the instru-ments, the production and the preservation of medical devices.

A crucial aspect is the sterile medical device storage in a dedicated area and protected, with limited access and constructive solutions aimed at ensuring a “sterile” envi-ronment completely isolated and non-pollutable.

Hence the need to create a barrier inside the through ster-ilzers, between clean and sterile, that prevents contact be-tween the areas.

The Eurosteam line is produced in order to fully meet this need through complete separation of the equipment on the sterile side called “Bioseal”, that is aligned and sealed with the wall.

Bioseal

Certificates, quality and construction standardsThe Eurosteam line equipment is CE marked with identifica-tion number issued by the notified body according to the European Directive 93/42/EEC and 2007/47/EEC as a medi-cal device and the European Directive 97/23/EC pressure equipment (PED) and European directive 2009/125/EEC (ecodesign).

Also to conform the following European directives: 2006/95/EC low-voltage directive, 2004/108/EEC for electromagnetic compatibility and 2006/42/EEC for machinery.

The construction is done in compliance with European Standard of reference UNI EN ISO 285: 2015 (steam steri-lizers) and those related to it UNI EN ISO 17665-1 (devel-opment, validation, and routine tests), CEI EN ISO 61010-1 (electrical safety), CEI EN ISO 61010-1-040 (electrical safe-ty), CEI EN ISO 61010-2-041 (electrical safety) CEI EN 60204-1 ISO (electrical), UNI EN ISO 15614-1: 2012 (welding pro-cedures), UNI EN ISO 287-1 (welders qualification), UNI CEI EN ISO 17050-1: 2005 (conformity assessment), UNI EN ISO 14971-1: 2000 (risk analysis), EN IEC 62304: 2006 (valida-tion of software) and EN IEC 62366: 2008 (human-machine interface).

All of that within a UNI EN ISO 9001 Quality System (quality certification) and UNI EN ISO 13485 (medical quality certifi-cation).

9

Main technical featuresAISI 304 stainless steel frame and panelsAISI 316Ti, 8mm thick stainless steel Sterilization chamber, easy to clean and fully drainable. Collecting chamber bottom and central filtering. AISI 316ti stainless steel, 5 mm thick chamber jacket. Jacket with chamber total covering. Door totally in stainless steel AISI 316TI or superior, thickness 30 mm. Mirrored finishing for internal chamber doors.Automatic sliding device for vertical/horizontal door/s. Door closure by dynamic «air chamber» gasket. Chamber and steam generator isolated with fire retardant mattress , covered with stainless steel panels.Condensation line and steam line totally isolated with silicon material with internal fibers of Kevlar. Bio-seal shield: separation between sterile side and clean side. AISI 304 stainless steel electrical steam generator with automatic drain device (E).AISI 304 stainless steel or superior steam thermal exchange generator (SE). Direct steam to the chamber (S). Electrical direct steam generator (ES). Disconnection water device. (optional)Generator water preheating, Energy recovery system, Water generator de-gassing system. (optional) Air-check steam control device (quality steam). (optional) Drain temperature control device. (optional) Mechanical dry vacuum pump. 5 years warranty.Double data process system. PLC Siemens - Medical Device classification. Touch screen Siemens TP900 Comfort, 9 inches, full color and high resolution. Built-in alphanumeric printer. Remote maintenance control device. (optional) Ability to operate in accordance with 21 CFR Part 11 FDA. B&D Test Electronic / Automatic. (optional) Front access for routine maintenance.Second touch-screen on unloading side. (optional) Steam filter system device. (optional) Liquid cycle with natural cooling device. (optional)

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.

17

18

28

19

30

20

31 32

26

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EUROPEAN INFECTION CONTROL

Series Models 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 1600x1850x8904 MD.STM.4.450.1/2HSD.E/S/ES/SE 449 6 660x680x1000 1600x1850x11904 MD.STM.4.600.1/2HSD.E/S/ES/SE 584 8 660x680x1300 1600x1850x14904 MD.STM.4.700.1/2HSD.E/S/ES/SE 718 10 660x680x1600 1600x1850x17904 MD.STM.4.900.1/2HSD.E/S/ES/SE 897 12 660x680x2000 1600x1850x21906 MD.STM.6.500.1/2HSD.E/S/ES/SE 485 6 660x1050x700 1600x1850x8506 MD.STM.6.700.1/2HSD.E/S/ES/SE 693 9 660x1050x1000 1600x1850x11506 MD.STM.6.900.1/2HSD.E/S/ES/SE 901 12 660x1050x1300 1600x1850x14506 MD.STM.6.1100.1/2HSD.E/S/ES/SE 1108 15 660x1050x1600 1600x1850x1750

Definition of model code:

● Eurosteam: Satured steam autoclave

● Medical device - “MD”: Hospital Application

● Steam- “STM”: Sterilization agent

● Series - “1/2/4/6”: STU load capacity (STU dimensions 300X300 mm) considering the chamber section ● Volume - “da 80 a 1108 lt”: Chamber capacity in litres

● Number of doors- “1 o 2”.

● Doors movement - “HSD”:Horizontal automatic sliding doors

● Doors movement - “VSD”:Vertical automatic sliding doors

● Heating: E: Electrical internal steam generator S: Centralized steam ES: Electrical and steam SE: Internal Steam exchanger

Example. Model MD.STM.4.900.2VSD.E

Medical deviceSteam12 STU900 liters2 Automatic vertical sliding doorsInternal electrical steam generator

Example. Model MD.STM.6.500.2HSD.ES

Medical deviceSteam6 STU485 liters2 Automatic horizontal sliding doorsInternal electrical steam generator andcentralized steam connection

Range of EUROSTEAM productsVSD series vertical sliding doors

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

1 MD.STM.1.80 .1/2VSD.E/S/ES/SE 80 1 330x330x700 890x1850x8901 MD.STM.1.100.1/2VSD.E/S/ES/SE 110 1.5 330x330x1000 890x1850x11902 MD.STM.2.150.1/2VSD.E/S/ES/SE 158 2 330x680x700 890x1850x8902 MD.STM.2.200.1/2VSD.E/S/ES/SE 212 3 ISO 460x460x1000 1020x1850x11902 MD.STM.2.250.1/2VSD.E/S/ES/SE 275 4 ISO 460x460x1300 1020x1850x14902 MD.STM.2.220.1/2VSD.E/S/ES/SE 218 3 ISO 460x680x700 1020x1850x8904 MD.STM.4.300.1/2VSD.E/S/ES/SE 315 4 660x680x700 1400x1850x8904 MD.STM.4.450.1/2VSD.E/S/ES/SE 449 6 660x680x1000 1400x1850x11904 MD.STM.4.600.1/2VSD.E/S/ES/SE 584 8 660x680x1300 1400x1850x14904 MD.STM.4.700.1/2VSD.E/S/ES/SE 718 10 660x680x1600 1400x1850x17904 MD.STM.4.900.1/2VSD.E/S/ES/SE 897 12 660x680x2000 1400x1850x2190

HSD series horizontal sliding doors

11

1 STU sterilization basket

Example. Model MD.STM.4.900.2VSD.E

Medical deviceSteam12 STU900 liters2 Automatic vertical sliding doorsInternal electrical steam generator

Example. Model MD.STM.6.500.2HSD.ES

Medical deviceSteam6 STU485 liters2 Automatic horizontal sliding doorsInternal electrical steam generator andcentralized steam connection

Accessories

Internal trolleySeries 1 (1-1,5 US)Series 2.150 (2 US)Series 2 ( 3-4 ISO)Serie s4 (4-6-8-12 US)

Internal trolleySeries 6.500 (6 US)Series 6.700 (9 US)Series 6.900 (12 US)Series 6.1100 (15 US)

Base gridSeries 1-2-4

Automatic loadingdeviceSeries 1-2-4

Automatic loadingdeviceSeries 6

Automatic unloadingdeviceSeries 1-2-4

Automatic unloadingdeviceSeries 6

Base grid withshelfSeries 1-2-4

ISO sterilization basket

Fixed heightexternal trolleySeries 1-2-4

Fixed heightexternal trolleySeries 6

Adjustable heightexternal trolleySeries 1-2-4

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. 14/2016-illustrations, descriptions and technical data may change without notice.

ALS HeadquarterAngelantoni Life Science srl

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

T. +39 075 89551 - F. +39 075 [email protected] - www.angelantoni.it

ALS Milan BranchAngelantoni Life Science srl

viale Monza, 291 - 20126 Milano (MI)T. (+39) 02.939701.1 - F. (+39) 02.93970123

[email protected] - www.angelantoni.it

ALS products are distributed in North-Central Europe bySchlumbohm

Medizin-Labor-Technologie GmbH Grenzkehre 1

21079 Hamburg - GermanyT. +49 40 769 150 0 - F. +49 40 769 150 26

[email protected] www.schlumbohm-medizintechnik.de

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