STEAM STERILIZERS FOR HOSPITAL USE (Certified 93/42/EEC)
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MDSTM models are medical devices CE marked as Class IIb upon the MEDICAL DEVICE DIRECTIVES 93/42 and subsequent. They can be used for quick and safe sterilization process for medical instruments and tools able to resist to high temperature. Fully in compliance with EN 285. Besides, the construction of MDSTM.4 comply with the EU standards. The sterilization is done by saturated steam.
CHAMBER - JACKET - DOOR:
Totally in stainless steel AISI 316Ti, chamber thickness 8mm, jacket thickness 5 mm and door thickness 20mm. Warranty period of 20 years. Isolation is guarantee by a Kevlar & Silicon fibber material to reduce the external temperature emission below 45°C. Finishing by electro-pulsing with a final result roughness below 0,02 μm
FRAME – EXTERNAL PANELS:
The structure frame is a stainless steel tubular (30x50mm) AISI 304 and all external panels are in stainless steel AISI 304. All models are constructed to guarantee frontal access for maintenance activity.
HYDRAULIC PLANT:
Totally in stainless steel AISI 316L including all junction, proper for sanitary use with no risk of condensation deposit. Isolation by Isolation is guarantee by a Kevlar & Silicon fibber material to reduce the external temperature emission below 45°C. All vales are pneumatic in stainless steel AISI 316L
SEALING GASKET:
The closure between the door and the chamber is guarantee by a new dynamic gasket type “air chamber”; the compressed air goes into the gasket to inflate it through the door; the section of the gasket is rectangular to guarantee a mayor contact surface and reduce the risk of air leaking and pressure lost.
VACUUM PUMP:
Dry vacuum pump with zero water consumption during vacuum generation, totally compatible with steam and high temperature. Industrial and mechanical pump with no necessity of consumables or fluid to be operated. Dry vacuum pump supplied by BUSCH company.
BIO-SEAL BARRIER:
All pass-through models are equipped with a bio-seal barrier for sanitary safe; hermetic shield in stainless steel AISI 304 without welding and junction. It guarantee a full & safety separation between the two sides for no risk of air cross contamination.
INDUSTRIAL PLC:
All models are equipped with an industrial PLC – double – integrated and in compliance with MDD 93/42/CEE; it’s supplied by Siemens company (Model: ET200S); it guarantees the repeatability and safety of sterilization cycle following the F(0) curve.
ELECTRICAL BOARD:
All models are equipped with IP 54 electrical board to guarantee total protection from water and dust of all electronic components.
TOUCH SCREEN:
All models are equipped with touch screen monitor, HD colour, 9 inch – always using destination country language; it’s supplied by Siemens company (Model: TP700 Comfort) - easy interface to manage all technical and operational functions. It’s visualized: cycle parameters, maintenance, validation, alarms, cycle diagrams – it’s possible to connect to a PC and to USB pen-drive.
SOFTWARE CONNECTION & MAINTENANCE REMOTE CONTROL:
All models are equipped with an industrial PLC with an Ethernet connection with traceability software and remote maintenance control device; the traceability system is totally compatible for all equipment of the CSSD; the maintenance software is able to keep under control the machine from a PC station.