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- Steril Division
Export Office Via Achille Grandi 16, 20017 Mazzo di Rho (MI) ITALY +39 02 939 701 43 / +39 02 939 701 21 Head Quarter Localit Cimacolle 464 06056 Massa Martana (PG) - ITALY +39 075 489551 +39 075 8955200
EN 50081-1
ENV 50140
ENV 50141
Furthermore it has been designed to fulfil the European Directives like: Electromagnetic Compatibility Directive 89/336/EEC, 92/31/EEC, 93/68/EEC. Low voltage Directive 72/23/EEC, 93/68/EEC. IMPORTANT !! The cabinets we produce, according to the above statements, are manufactured in compliance with the laws on safety into force. Particularly, they are manufactured in compliance with Art. 6 Dlgs 626/94 and its modification (Italian law in compliance with European Directive EEC/89/391) on the DUTY OF DESIGNERS, OF MANUFACTURERS, OF SUPPLIERS AND INSTALLATORS. The cabinets are NOT submitted to the directive EEC 93/42 on Medical Devices, as indicated in the definition of Medical Devices reported in art. 1 point 2a of the Directive mentioned. STERIL IS NOT responsible for damages to people and objects due to a non proper use of the cabinet, and due to a fail to comply with the user instructions and maintenance that are always supplied with the cabinets. Technical Specification Back panel and working tray in stainless steel AISI 304L 2B finishing, perforated. Front window and side walls in toughened glass. Lighting on working surface by means of 1 fluorescent lamps of 15W Construction structure in steel epoxy-polyester powder coated, resistant to the most common industrial disinfectants. Ventilation system by means of n motor blower dedicated to the one-way airflow in the working chamber, equal to 1 95% of the total involved air and to exhaust the remaining 5%. The motor blower is centrifugal type, direct driven motor with double aspiration and protection factor IP22. Air filtration by means of HEPA H14 type filter (refer to DIN 24184 and BS 3928) with efficiency of 99,999% at 0,3 micron particles size with DOP/DOS test (as defined to EN1822). Command and Controls Air ventilation control by means of manual electronic regulation of the revolution velocity of the motorblower. Tests control In our Quality Control Dept., according to our procedure WI-MFG-006 included in the Quality manual of Steril Equipment Division. The Quality System of Steril S.p.A. Equipment Division is certified in compliance to EN ISO 90012000 with a Certificate n CERT-00669-95-AQ-MIL-SINCERT/B released by DNV Det Norske Veritas. On request, validation tests at site with IQ/OQ protocols are available. Standard features Fluorescent light (n ) 1 Optional features Steel support stand epoxy polyester coated with wheels Electrical power socket 4A (left internal side) 15W germicidal lamp, wavelength 253.7 nm (UV-C) with s/s shield Exhaust HEPA filter Drain tray in s/s AISI 304 Closing plate Compressed air line with manual tap Nitrogen line with manual tap Vacuum line with manual tap
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Maintenance The replacement of filters and any other maintenance activity (control of the electric board) can be done from the upper part of the cabinet. Technical characteristics
Model Overall dimension (WxDxH) Safe working area dimension (WxDxH) Package dimension (WxDxH) Front opening height Net weight System ventilation data Flow rate (1) Heat emission at 25 C Noise level Lighting Service fluids Max pressure air / Nitrogen / CO2 Electrical data Voltage Frequency Power Absorption Electrical classification (with feeding cable) Protection category Power socket optional (protected by a single fuse 4A) Fluorescent lamps
(1)
Gemini 802x652,5x810 732x424x490 960x770x1020 260 70 335 130 <58 800 4 230V AC F+N+P.E. 50 150 2 1 2P+t 250V 10/16A IP55 1x15W
I AG FR
LE
770
960
1020
12
55
370
120
245
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