EUROWASHER - Angelantoni Group - Area …siteadm.angelantoni.it/Media/brc/BRC_0511.pdfinstrument...

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EUROWASHER Washing-thermo disinfector Medical device

Transcript of EUROWASHER - Angelantoni Group - Area …siteadm.angelantoni.it/Media/brc/BRC_0511.pdfinstrument...

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EUROPEAN INFECTION CONTROL

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Ser ies 16 and 32 with hor izontal s l id ing doors

Ergonomic load, rapidi ty and high product iv i ty

Ser ies 10, 15 and 18 with vert ical s l id ing doors

Compact dimensions, versat i l i ty and rapidi ty.

Series 10.300 VSD Series 15.450 VSD

Series 16.500 VSD

Series 18.500 VSD

Series 32.1000 VSD

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The Eurowasher range is a series of new generation wash-ing thermo-disinfectors, result of the most advanced de-sign by Schlumbohm & Angelantoni Life Science, Leader in the world of Infection Control.

German technology combined with Italian design and cre-ativity, together with the Corporate Know-how matured over decades of activity in the sector, have supported the development of equipment based on the concept of “total quality”, able to meet the requirements of an Elite market requiring total safety assurance, absolute reliability and sterilization processes that can be repeated in time, with-out burdening operators with the risk of assessment.

Total quality to produce medical devices with high con-struction standards, advanced techniques and innovative solutions.

Total quality for an environmentally-friendly project with almost zero impact on the environment by water con-sumption, and extremely low for electricity and heat dis-sipation.

Technology

Saving Use

SinergyKnow-how

Ability

Customer support

Exerience

The constant research for greater productivity and effi-ciency distinguishes and accompanies us on a design jour-ney aimed at “Safety”, “Total quality” and “Savings”.

“Saving” is one of the aims that we set ourselves in thedesign phase:

saving in operating consumption,

saving of maintenance with devices, solutions and components of high quality and reliability and long service life.

In a medical device manufacturing process, the instru-ment washing and disinfecting appliance plays a critical role, being a fundamental step to first bring down and then stabilise the microbial load and assure repeatable reduction over time.

The appliances of the Eurowasher instrument wash and disinfect range have been designed to be installed in the sterilization stations and are second only to the sterilizer for the intended use, which is to produce surgical instru-ments washed perfectly and with a significant SAL.

+50%Service life

Ser ies 10, 15 and 18 with vert ical s l id ing doors

Compact dimensions, versat i l i ty and rapidi ty.

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The automatic wash reduces contamination risks to be reduced, accelerates washing times, reduces costs and means the washing cycle can be validated.

In order to ensure that the process remains constant over time, the equipment in the Eurowasher range is fitted with devices and sensors to verify and confirm data and prevent any kind of error.

In fact, after experimental tests, constant monitoring of parameters is carried out. These parameters can af-fect the result and/or make it inconsistent over time, such as:

water pressure water temperature water jet moving speed water jet mechanical action chemical product added

The appliances in the Eurowasher range have been tested in compliance with the standard of reference as well as similar ones to assess washing quality.

Automatic washingWashing anddisinfection cycles

-Thermo-chemical washing and disinfection for surgical instruments at 93°C

- Thermo-chemical washing and disinfection for containers at 93°C

- Thermo-chemical washing and disinfection for surgical microinstruments at 93°C

- Thermo-chemical washing and disinfection for basins at 93°C for

- Thermo-chemical washing and disinfection for anaesthesia material at 65°C

- Thermo-chemical washing and disinfection for glass-ware and baby bottles at 93°C

- Thermo-chemical washing and disinfection for medical shoes at 65°C

- Equipment washing and self-disinfection

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The Eurowasher line is configured with the following cycles:

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As well as perfect cleaning of the instruments, it is essen-tial to achieve a substantial reduction of the microbial load at the end of the washing and disinfection process. Furthermore, a constant value should be obtained at the end of the process with a final SAL of 10”2 in order to be able to ensure an SAL of 10-6 after sterilization. Constant and precise monitoring of the “bioburden” allows the validity of disinfection, and the trend over time, to be assessed.

The thermochemical energy released by the chemical solution, diluted in hot water, allows to obtain a double effect by attacking the micro-organisms with two differ-ent activities overcoming their resistance.

Any equipment in the Eurowasher range is fitted with devices and sensors to verify and confirm data and to prevent any kind of error, in order to ensure the process as well as the final constant results.

After experimental tests, constant monitoring is carried out to check parameters that affect the result and/or make it constant over time, such as:

detergent and disinfectant dosage

checking PH on discharge

water temperature

contact time of water with the surface of the instruments (A0)

chemical residue after rinsing

The appliances in the Eurowasher range have been test-ed in compliance with the standard reference as well as similar ones to assess disinfection quality.

Disinfection

BiosealThe modern concept of a sterilization unit calls for equipment, flows, paths, procedures, checks and traceability that must be imple-mented in order to consider instruments’ “re-processing” safe.

Specifically, the separation of clean and dirty environments is thus essential to reduce con-tamination risks.

Hence the need to create a barrier inside the instrument wash and disinfect appliance, be-tween clean and dirty, that prevents contact between the areas.

The Eurowasher line is produced in order to fully meet this need through complete sepa-ration of the equipment on the sterile side - the so-called “Bioseal”, which is aligned and sealed with the wall.

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The Eurowasher line has a series of features that make the washing and disinfection cycle faster, compared with the classic instrument washer.

The care in the details of the plants, components and devices is affecting the washing and disinfection cycle perfor-mance, speeding up phases, reducing time and increasing the production capacity.In particular:

Quick cycles

The Eurowasher range features an ergonomic loading height enhanced by the door(s) horizontal sliding.

This makes it possible to easily reach all loading planes as well as making the arrangement of instruments, baskets, con-tainers, glassware, micro surgical instruments and clogs safer, reducing the risks of incidents due to operators’ visibility.

The Eurowasher line has been developed by applying environmentally friendly design with the aim of preserving the planet environment. AIC adopted innovative technical solutions and high quality components, in order to significantly reduce consumption and, therefore, reduce pollution throughout the entire cycle.

Highlighted aspects are:

● water consumption

● energy consumption

● recycling

Washing-disinfection chamber is designed to allow the circulation pump to work properly with a lower consumption of water.

20 % water Saving for each type of connection

Environmental impact

Ergonomic loading

the reduced amount of water per phase

the shape of the chamber to take water back to the pump quickly

water preheating

quick water loading

the high performance recirculation pump

the quick water discharge and turbulent flow drying through the impeller blades of the trolley the diffusers in the lower part of the chamber opposite the suction

-25%Cycle time

100%Recyclable

-40%Energy consumption

-20%Water consumption

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The position of the components, main units and operational phases to facilitate pre-assemblies and general assemblies, are analysed since the design phase, to significantly reduce times and costs in a serial produc-tion.

The reduction of phases and the repetition of assembly operations, to-gether with the optimisation of the semi-finished products, support the industrialisation of the production process and constant preservation of high quality standards of the product.

Validation is one of the most important operations as it allows verifying, after installation, whether design conditions are respected.

In particular, for the load object of the validation, we can verify that tem-perature, doses of chemical solutions and time fall within the correct parameters to ensure the effectiveness of the washing and disinfection process in compliance with the reference standard UNI EN ISO 15883-1.

Industrialisation

Validation

100%Recyclable

Directives, Certificates, Qualityand Construction StandardsThe Eurowasher line equipment is CE marked with the identification number issued by the Notified Body accord-ing to European Directive 93/42/EEC and 2007/47/EEC as a Medical Device and with European Directive 2009/125/EEC (eco-design).

They also comply with European Directives: 2006/95/EEC for Low Voltage, 2004/108/EEC for Electromagnetic com-patibility and 2006/42/EEC for Machinery.

Construction is done in compliance with the European Standards of reference UNI EN ISO 15883-1-2:2009 (wash-ing and disinfection) and those related to it. UNI EN ISO 17665-1 (development, validation and routine testing), CEI EN ISO 61010-1 (electrical safety), CEI EN ISO 61010-1-040 (electrical safety), CEI EN ISO 61010-2-041 (electrical safety) CEI EN ISO 60204-1 (electrical equipment), UNI CEI EN ISO 17050-1:2005 (conformity assessment), UNI EN ISO 14971-1:2000 (risk analysis), EN IEC 62304:2006 (software validation) and EN IEC 62366:2008 (human-machine inter-face).All of that within a UNI EN ISO 9001 Quality System (quality certification) and UNI EN ISO 13485 (medical qual-ity certification).

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Definition of the model code:● Eurowasher: Surgical instrument washing and disinfecting device

● Medical Device - “MD”: Hospital Application

● Termochemical - “WSD”: Washing and Disinfection Medium

● Series - “10/15/16/18/32”: DIN tray loading capacity (dimensions 480X240x50 mm)

● Volume liters - “from 328 to 1010 lt”: Chamber capacity in litres

● Execution - “1 o 2”: Numbers of doors

● Door movement - “HSD”: Automatic horizontal sliding door

● Door movement - “VSD”: Automatic vertical sliding door

● Heating: E: Internal Electrical Steam Generator S: Centralized steam ES: Electrical-steam SE: Steam Exchanger

Series Model Capacity (lt)

Trays 1 DIN

Chamber dimensions (WxHxD mm)

Overall dimensions (WxHxD mm)

16 MD.WSD.16.500.1/2HSD.E/SE/E-SE 514 16 700X1050X700 1600X2000X850

32 MDWSD.32.1000.1/2HSD.E/SE/E-SE 1010 32 700X1050X1375 1600X2000X1525

HSD series horizontal sliding doors

Range of EUROWASHER productsVSD series vertical sliding doors

Series Model Capacity (lt)

Trays 1 DIN

Chamber dimensions (WxHxD mm)

Overall dimensions (WxHxD mm)

10 MD.WSD.10.300.1/2VSD.E/SE/E-SE 328 10 700x670x700 1050X2000X85015 MD.WSD.15.450.1/2VSD.E/SE/E-SE 446 15 700X670X950 1050X2000X110018 MD.WSD.18.500.1/2VSD.E/SE/E-SE 528 18 700X795X950 1050X2000X1100

Example model MDWSD.10.300.2VSD.EMedical DeviceTermochemical10 DIN300 litri2 Automatic vertical sliding doorsElectrical internal steam generator

Example model MDWSD.16.500.1HSD.SMedical DeviceTermochemical16 DIN500 litri1 Automatic vertical sliding doorConnection to central steam

Accessories

External trolley Adjustable external trolley Automatic loading system

Automatic unloading system

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Main construction featuresAISI 304 stainless steel frame, front and side panels.AISI 316L, 2 mm thickness washing chamber. Chamber bottom with central drain and filtration.Door/s in double high resistance thermal glass with argon/krypton gas.Horizontal or vertical sliding door/s.Door/s sealing by dynamic «air chamber» gasket.Drying unit complete with bacteriological filter, Turbo fan and electric heaters.Rotating washing arms on each trolley.Chamber perfectly drainable and cleanable.High-performance re-circulation pump.AISI 304 stainless steel Idraulic pipeline. Ergonomic loading height (HSD models).Double data detection systems Siemens Simatic ET200S integrated safety, programmable electronic controller.Touch screen Siemens TP700 or TP900 Comfort, 7 or 9 inches, full color and high resolution.Second touch screen on unloading side. (optional)Bio-seal shield: separation between dirty side and clean side. (optional)Built-in alphanumeric printer.Different types of internal trolleys available.Automatic connection among internal trolley and the device.Stainless steel steam condenser. (optional)Stainless steel AISI 304 containment tank for cold water. (optional)Stainless steel AISI 304 pre-heating tank for treated water. (optional)Stainless steel AISI 304 recovery tank for rinsing water. (optional)Remote connection-ready. (optional)USB connection for data back-up.Water drain pump. (optional)Monitoring and control system of the rotation of the spray arms. (optional)Central chemical dosing device. (optional)Chemicals dispenser with flow meter. (4th chemical dispenser – optional)Water flow meter device. (optional)Traceability system connection.Total integrated electrical board with IP protection and telescopic arm.

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.

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5-LEVEL WASHING TROLLEY 3-LEVEL WASHING TROLLEY

MEDICAL SHOES TROLLEY

MICRO-SURGERY TROLLEYLAPAROSCOPY TROLLEY

BASINS TROLLEY

BABY BOTTLES TROLLEY “DA VINCI” TROLLEY

Internal trolley for surgical instruments“Da Vinci” is designed for washing and disinfecting surgical instruments used by the “Da Vinci Surgical System” Robot

CONTAINER TROLLEY

ANESTHESIA TROLLEY

GLASSWARE TROLLEY

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SERIES 10 SERIES 15 SERIES 18TRAYS ● 10 trays (x 1DIN) ● 15 trays (x 1DIN) ● 18 trays (x 1DIN)

HIGH TRAYS ● 6 trays (h max 110 mm) ● 9 trays (h max 110 mm) ● 12 trays (h max 110 mm)

ANESTHESIA

● 6 tubes ( max 1.5 m)● 6 breathing bags or24 breathing masks.● 10 inhaler nozzles

● free charging space

● 6 tubes ( max 1.5 m)● 6 breathing bags or30 breathing masks.● 10 inhaler nozzles

● free charging space

● 8 tubes ( max 1.5 m)● 10 breathing bags or

40 breathing masks.● 18 inhaler nozzles

● free charging space

MICROSURGERY

● 4 micro-surgey kits (various dimensions)

● free charging space

● 4 micro-surgey kits (various dimensions)

● free charging space

● 5 micro-surgey kits (various dimensions)

● free charging space

SHOES ● 10 pairs of medical shoes ● 16 pairs of medical shoes ● 24 pairs of medical shoes

GLASSWARE● 18 pieces (h max 300 mm)● 36 pieces (h max 160 mm)● free space (h max 50 mm)

● 22 pieces (h max 300 mm)● 44 pieces (h max 160 mm)● free space (h max 50 mm)

● 35 pieces (h max 300 mm)● 60 pieces (h max 160 mm)● free space (h max 50 mm)

BASINS ● basins of different sizes and capacity on three levels

● basins of different sizes and capacity on three levels

● basins of different sizes and capacity on three levels

CONTAINER ● 2 container with covers (1US) ● 3 container with covers (1US) ● 6 container with covers (1US)

LAPAROSCOPY● 40 laparoscopic tools (various dimensions)

● 2 free tray (1DIN)

● 60 laparoscopic tools (various dimensions)

● 4 free tray (1DIN)

● 78 laparoscopic tools (various dimensions)

● 3 free tray (1DIN)

BABY BOTTLES ● baby bottles - different sizes● caps and nipples

● baby bottles - different sizes● caps and nipples

● baby bottles - different sizes● caps and nipples

SERIES 16 SERIES 32TRAYS ● 16 trays (x 1DIN) ● 32 trays (x 1DIN)

HIGH TRAYS ● 10 trays (h max 110 mm) ● 20 trays (h max 110 mm)

ANESTHESIA

● 12 tubes ( max 1.5 m)● 8 breathing bags or36 breathing masks.● 14 inhaler nozzles

● free charging space

● 24 tubes ( max 1.5 m)● 16 breathing bags or

72 breathing masks.● 28 inhaler nozzles

● free charging space

MICROSURGERY

● 6 micro-surgey kits (various dimensions)

● free charging space

● 12 micro-surgey kits (various dimensions)

● free charging space

SHOES ● 18 pairs of medical shoes ● 36 pairs of medical shoes

GLASSWARE● 36 pieces (h max 300 mm)● 36 pieces (h max 160 mm)● free space (h max 50 mm)

● 72 pieces (h max 300 mm)● 72 pieces (h max 160 mm)● free space (h max 50 mm)

BASINS ● basins of different sizes and capacity on four levels

● basins of different sizes and capacity on four levels

CONTAINER ● 4 container with covers (1US) ● 8 container with covers (1US)

LAPAROSCOPY● 80 laparoscopic tools (various dimensions)

● 2 free tray (1DIN)

● 160 laparoscopic tools (various dimensions)

● 2 free tray (1DIN)

BABY BOTTLES ● baby bottles - different sizes● caps and nipples

● baby bottles - different sizes● caps and nipples

Load capacity HSD series - horizontal sliding doors

Load capacity VSD series - vertical sliding doors

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.

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 [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