Steelco VS1/1V Use And Maintenance Manual
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Steelco VS1/1V Use And Maintenance Manual

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0398
0051
Steelco VS series
Use and Maintenance Manual
1
Steelco S.p.A.
Via Balegante, 27
31039 - Riese Pio X (TV)
ITALY
Tel. - +39 0423 7561
Fax. - +39 0423 755528
www.steelcospa.com

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  • Page 1 Steelco S.p.A. Via Balegante, 27 31039 - Riese Pio X (TV) ITALY Tel. - +39 0423 7561 Fax. - +39 0423 755528 www.steelcospa.com 0398 0051 Steelco VS series Use and Maintenance Manual...
  • Page 3 NOTIZIE DI COPYRIGHT The Copyright 2014 of this document is property of Steelco S.p.A. No part of this document may be copied, transmitted or divulged to third parties without the written authorization of the president of Steelco S.p.A. AUTHORS APPROVED...

  • Page 4: Table Of Contents

      Applicable Standards ...................15     CONSTRUCTIONAL CHARACTERISTICS .............16   2.1.1   Autoclaves accessories ..................42   2.1.2   Steelco VS series performances ..............44   2.1.3   Unit classification (for all versions) .............44   2.1.4   Noise/Vibrations ....................44   2.1.5  ...
  • Page 5   Conservation of sterilized material ..............109     PRINTOUTS ........................110     Printout management ..................110     Complete cycle report ..................112     Cycle Report Data ....................114     Cycle Result ......................114     Report Trend ......................114     Digital Inputs/Outputs Status Report ..............114  ...
  • Page 6 INDEX OF FIGURES   Figure 1 –Main components ______________________________________________________________________________ 17   Figure 2 – Labelling design ______________________________________________________________________________ 48   Figure 3 – Operator position VS1 _________________________________________________________________________ 53   Figure 4 – Operator position VS12 ________________________________________________________________________ 53   Figure 5 – Operator position VS 18 ________________________________________________________________________ 53  ...
  • Page 7 INDEX OF TABLES   Table 1 – Classification as standard EN 61010-1 _____________________________________________________________ 44   Table 2 – Heat loss _____________________________________________________________________________________ 44   Table 3 – Environmental characteristics ____________________________________________________________________ 50   Table 4 – Alarms ______________________________________________________________________________________ 100   Table 5 – Routine maintenance __________________________________________________________________________ 103  ...
  • Page 8 And their distribution particularly to other companies. Steelco S.p.A. Reserves the right to act under the law should these warnings not be complied with. Steelco S.p.A. warns that all operations concerning software and hardware must be carried out with the utmost care.
  • Page 9 SALE AND SUPPORT CENTERS Steelco S.p.A. Via Balegante, 27 31039 Riese Pio X (TV) www.steelcospa.com Tel. 0039 0423 7561 Fax 0039 0423 755528...
  • Page 10 REFERENCE NOTES The warning conditions are highlighted in the following way:  Description of warning Operators must pay due care to these types of messages. In the manual, the term operator describes the person in charge of usually operating the machine, and who has the following tasks: 1.

  • Page 11: Introduction

    Product Presentation The new range of Steelco VS Series autoclaves includes models with 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 12H, 15H, 18H sterilization units. Steelco VS Series is characterized by an innovative line and a careful and flexible design. The models are available both with a single and double door, and left- or right- technical compartment.

  • Page 12: Identification Of The Various Model

    Identification of the various model The machine model described in this manual is identified by the symbol "VS" followed by: The first number indicates the capacity of the sterilization chamber: 1 sterilization units 1,5 sterilization units 2 sterilization units 3 sterilization units 4 sterilization units 6 sterilization units 8 sterilization units...

  • Page 13: General Notices

    General notices The product and/or its accessories must always be used in compliance with the procedures set forth in this manual. They must never be used for other than their intended purposes. 1.5.1 Clauses of supply Concerning installation and assembly carried out by third parties, the manufacturer shall in no way be held liable for: a) work carried out improperly, not in accordance with good construction practices, concerning: pipes and accessories for the adding and discharge of various fluids,...

  • Page 14: Conditions Of Guarantee

    The guarantee is not applicable to expendable materials and routine maintenance. Fields of use The Steelco VS series autoclaves are designed for hospital sterilization, i.e. they are suitable to operate on porous and rubber materials, on surgical instruments, on materials pre-packaged into bags, provided they can withstand working temperatures of up to 140°C and maximum pressure of 2.5 bar.

  • Page 15: Applicable Standards

    Applicable Standards The sterilizers dealt with by this document comply with directives 97/23/EC and standards: ASME VIII div 1 & div 2 - Rules for Construction of Pressure Vessels EN13445-3 annex B & C – EN13445-3 Cl.18 - Pressure Vessel Code UNI EN 288-3 / EN15614-1 - Manufacturing and control procedure for welded joints UNI EN 473 - Qualification of personnel responsible for non-destructive controls UNI EN ISO 9712:2012 - non-destructive testing —...

  • Page 16: Constructional Characteristics

    2. CONSTRUCTIONAL CHARACTERISTICS The new Steelco VS series autoclaves are characterized by a body completely in stainless steel AISI 316L/316Ti with parallelepiped chamber and tilting towards the drain, with cylindrical chamber for models 1-1,5-2; thermal insulation is guaranteed by an innovative and practical textile cover.

  • Page 17: Figure 1 -Main Components

    Sterilization chamber Electrical panel Technical compartment containing the hydraulic system Control panel Steam generator (only versions “E”, “I”, “EV” and “EI”) Figure 1 –Main components Upon the client's request at the moment of the order, the electrical panel, the technical compartment containing the hydraulic system and the control panel can be installed on the left side of the sterilization chamber instead of the right side.
  • Page 18 Technical characteristics of VS 1 VERSIONS MODEL U.M. VS1/1E VS1/1V VS1/1I VS1/1EV VS1/1EI Ø 420.0 Ø 420.0 Ø 420.0 Ø 420.0 Ø 420.0 Width inch Ø 16.5 Ø 16.5 Ø 16.5 Ø 16.5 Ø 16.5 Ø 420.0 Ø 420.0 Ø 420.0 Ø...
  • Page 19 MODEL U.M. VS1/2E VS1/2V VS1/2I VS1/2EV VS1/2EI Ø 420.0 Ø 420.0 Ø 420.0 Ø 420.0 Ø 420.0 Width inch Ø 16.5 Ø 16.5 Ø 16.5 Ø 16.5 Ø 16.5 Ø 420.0 Ø 420.0 Ø 420.0 Ø 420.0 Ø 420.0 Height inch Ø...
  • Page 20 Technical characteristics of VS 1,5 VERSIONS MODEL U.M. VS1.5/1E VS1.5/1V VS1.5/1I VS1.5/1EV VS1.5/1EI Ø 420.0 Ø 420.0 Ø 420.0 Ø 420.0 Ø 420.0 Width inch Ø 16.5 Ø 16.5 Ø 16.5 Ø 16.5 Ø 16.5 Ø 420.0 Ø 420.0 Ø 420.0 Ø...
  • Page 21 MODEL U.M. VS1.5/2E VS1.5/2V VS1.5/2I VS1.5/2EV VS1.5/2EI Ø 420.0 Ø 420.0 Ø 420.0 Ø 420.0 Ø 420.0 Width inch Ø 16.5 Ø 16.5 Ø 16.5 Ø 16.5 Ø 16.5 Ø 420.0 Ø 420.0 Ø 420.0 Ø 420.0 Ø 420.0 Height inch Ø...
  • Page 22 Technical characteristics of VS 2 VERSIONS MODEL U.M. VS2/1E VS2/1V VS2/1I VS2/1EV VS2/1EI 440.0 440.0 440.0 440.0 440.0 Width inch 17.3 17.3 17.3 17.3 17.3 700.0 700.0 700.0 700.0 700.0 Height inch 27.6 27.6 27.6 27.6 27.6 645.0 645.0 645.0 645.0 645.0 Depth...
  • Page 23 MODEL U.M. VS2/2E VS2/2V VS2/2I VS2/2EV VS2/2EI 440.0 440.0 440.0 440.0 440.0 Width inch 17.3 17.3 17.3 17.3 17.3 700.0 700.0 700.0 700.0 700.0 Height inch 27.6 27.6 27.6 27.6 27.6 670.0 670.0 670.0 670.0 670.0 Depth Chamber inch 26.4 26.4 26.4 26.4...
  • Page 24 Technical characteristics of VS 3 VERSIONS MODEL U.M. VS3/1E VS3/1V VS3/1I VS3/1EV VS3/1EI 440.0 440.0 440.0 440.0 440.0 Width inch 17.3 17.3 17.3 17.3 17.3 700.0 700.0 700.0 700.0 700.0 Height inch 27.6 27.6 27.6 27.6 27.6 945.0 945.0 945.0 945.0 945.0 Depth...
  • Page 25 MODEL U.M. VS3/2E VS3/2V VS3/2I VS3/2EV VS3/2EI 440.0 440.0 440.0 440.0 440.0 Width inch 17.3 17.3 17.3 17.3 17.3 700.0 700.0 700.0 700.0 700.0 Height inch 27.6 27.6 27.6 27.6 27.6 970.0 970.0 970.0 970.0 970.0 Depth Chamber inch 38.2 38.2 38.2 38.2...
  • Page 26 Technical characteristics of VS 4 VERSIONS MODEL U.M. VS4/1E VS4/1V VS4/1I VS4/1EV VS4/1EI 670.0 670.0 670.0 670.0 670.0 Width inch 26.4 26.4 26.4 26.4 26.4 700.0 700.0 700.0 700.0 700.0 Height inch 27.6 27.6 27.6 27.6 27.6 686.0 686.0 686.0 686.0 686.0 Depth...
  • Page 27 MODEL U.M. VS4/2E VS4/2V VS4/2I VS4/2EV VS4/2EI 670.0 670.0 670.0 670.0 670.0 Width inch 26.4 26.4 26.4 26.4 26.4 700.0 700.0 700.0 700.0 700.0 Height inch 27.6 27.6 27.6 27.6 27.6 710.0 710.0 710.0 710.0 710.0 Depth Chamber inch 28.0 28.0 28.0 28.0...
  • Page 28 Technical characteristics of VS 6 VERSIONS MODEL U.M. VS6/1E VS6/1V VS6/1I VS6/1EV VS6/1EI 670.0 670.0 670.0 670.0 670.0 Width inch 26.4 26.4 26.4 26.4 26.4 700.0 700.0 700.0 700.0 700.0 Height inch 27.6 27.6 27.6 27.6 27.6 986.0 986.0 986.0 986.0 986.0 Depth...
  • Page 29 MODEL U.M. VS6/2E VS6/2V VS6/2I VS6/2EV VS6/2EI 670.0 670.0 670.0 670.0 670.0 Width inch 26.4 26.4 26.4 26.4 26.4 700.0 700.0 700.0 700.0 700.0 Height inch 27.6 27.6 27.6 27.6 27.6 1010.0 1010.0 1010.0 1010.0 1010.0 Depth Chamber inch 39.8 39.8 39.8 39.8...
  • Page 30 Technical characteristics of VS 8 VERSIONS MODEL U.M. VS8/1E VS8/1V VS8/1I VS8/1EV VS8/1EI 670.0 670.0 670.0 670.0 670.0 Width inch 26.4 26.4 26.4 26.4 26.4 700.0 700.0 700.0 700.0 700.0 Height inch 27.6 27.6 27.6 27.6 27.6 1286.0 1286.0 1286.0 1286.0 1286.0 Depth...
  • Page 31 MODEL U.M. VS8/2E VS8/2V VS8/2I VS8/2EV VS8/2EI 670.0 670.0 670.0 670.0 670.0 Width inch 26.4 26.4 26.4 26.4 26.4 700.0 700.0 700.0 700.0 700.0 Height inch 27.6 27.6 27.6 27.6 27.6 1310.0 1310.0 1310.0 1310.0 1310.0 Depth Chamber inch 51.6 51.6 51.6 51.6...
  • Page 32 Technical characteristics of VS 10 VERSIONS MODEL U.M. VS10/1E VS10/1V VS10/1I VS10/1EV VS10/1EI 670.0 670.0 670.0 670.0 670.0 Width inch 26.4 26.4 26.4 26.4 26.4 700.0 700.0 700.0 700.0 700.0 Height inch 27.6 27.6 27.6 27.6 27.6 1586.0 1586.0 1586.0 1586.0 1586.0 Depth...
  • Page 33 MODEL U.M. VS10/2E VS10/2V VS10/2I VS10/2EV VS10/2EI 670.0 670.0 670.0 670.0 670.0 Width inch 26.4 26.4 26.4 26.4 26.4 700.0 700.0 700.0 700.0 700.0 Height inch 27.6 27.6 27.6 27.6 27.6 1610.0 1610.0 1610.0 1610.0 1610.0 Depth Chamber inch 63.4 63.4 63.4 63.4...
  • Page 34 Technical characteristics of VS 12 VERSIONS MODEL U.M. VS12/1E VS12/1V VS12/1I VS12/1EV VS12/1EI 670.0 670.0 670.0 670.0 670.0 Width inch 26.4 26.4 26.4 26.4 26.4 700.0 700.0 700.0 700.0 700.0 Height inch 27.6 27.6 27.6 27.6 27.6 1940.0 1940.0 1940.0 1940.0 1940.0 Depth...
  • Page 35 MODEL U.M. VS12/2E VS12/2V VS12/2I VS12/2EV VS12/2EI 670.0 670.0 670.0 670.0 670.0 Width inch 26.4 26.4 26.4 26.4 26.4 700.0 700.0 700.0 700.0 700.0 Height inch 27.6 27.6 27.6 27.6 27.6 1940.0 1940.0 1940.0 1940.0 1940.0 Depth Chamber inch 76.4 76.4 76.4 76.4...
  • Page 36 Technical characteristics of VS 12 H VERSIONS MODEL U.M. VS12H/1E VS12H/1V VS12H/1I VS12H/1EV VS12H/1EI 670.0 670.0 670.0 670.0 670.0 Width inch 26.4 26.4 26.4 26.4 26.4 1050 1050 1050 1050 1050 Height inch 41.3 41.3 41.3 41.3 41.3 1286.0 1286.0 1286.0 1286.0 1286.0...
  • Page 37 MODEL U.M. VS12H/2E VS12H/2V VS12H/2I VS12H/2EV VS12H/2EI 670.0 670.0 670.0 670.0 670.0 Width inch 26.4 26.4 26.4 26.4 26.4 1050.0 1050.0 1050.0 1050.0 1050.0 Height inch 41.3 41.3 41.3 41.3 41.3 1310.0 1310.0 1310.0 1310.0 1310.0 Depth Chamber inch 51.6 51.6 51.6 51.6...
  • Page 38 Technical characteristics of VS 15 H VERSIONS MODEL U.M. VS15H/1E VS15H/1V VS15H/1I VS15H/1EV VS15H/1EI 670.0 670.0 670.0 670.0 670.0 Width inch 26.4 26.4 26.4 26.4 26.4 1050 1050 1050 1050 1050 Height inch 41.3 41.3 41.3 41.3 41.3 1586.0 1586.0 1586.0 1586.0 1586.0...
  • Page 39 MODEL U.M. VS15H/2E VS15H/2V VS15H/2I VS15H/2EV VS15H/2EI 670.0 670.0 670.0 670.0 670.0 Width inch 26.4 26.4 26.4 26.4 26.4 1050.0 1050.0 1050.0 1050.0 1050.0 Height inch 41.3 41.3 41.3 41.3 41.3 1610.0 1610.0 1610.0 1610.0 1610.0 Depth Chamber inch 63.4 63.4 63.4 63.4...
  • Page 40 Technical characteristics of VS 18 H VERSIONS MODEL U.M. VS18H/1E VS18H/1V VS18H/1I VS18H/1EV VS18H/1EI 670.0 670.0 670.0 670.0 670.0 Width inch 26.4 26.4 26.4 26.4 26.4 1050 1050 1050 1050 1050 Height inch 41.3 41.3 41.3 41.3 41.3 1886.0 1886.0 1886.0 1886.0 1886.0...
  • Page 41 MODEL U.M. VS18H/2E VS18H/2V VS18H/2I VS18H/2EV VS18H/2EI 670.0 670.0 670.0 670.0 670.0 Width inch 26.4 26.4 26.4 26.4 26.4 1050.0 1050.0 1050.0 1050.0 1050.0 Height inch 41.3 41.3 41.3 41.3 41.3 1910.0 1910.0 1910.0 1910.0 1910.0 Depth Chamber inch 75.2 75.2 75.2 75.2...

  • Page 42: Autoclaves Accessories

    2.1.1 Autoclaves accessories Below are the accessories available for the autoclaves Steelco VS. LOADING RACKS WITH SHELVES Loading rack made of AISI 316L Model: VS 2 with two shelves capacity 2 STU. Loading rack made of AISI 316L Model: VS 3...
  • Page 43 TRANSPORT TROLLEY Transport trolley made of AISI 316L with fixed height Model: All models capacity from 1 to 9 STU. Transport trolley made of AISI 316L with adjustable height and Model: VS 4 – VS 6 – VS 8 – VS 10 – VS 12 capacity from 4 to 6 STU.

  • Page 44: Steelco Vs Series Performances

    Table 1 – Classification as standard EN 61010-1 NOTE: The Steelco VS Series units can be supplied (upon request) also with a power supply voltage at 60 Hz frequency; in this case, this frequency is indicated on the CE tag.

  • Page 45: Electromagnetic Compatibility

    2.1.6 Electromagnetic compatibility The Steelco VS series units require special precautions with regards to electromagnetic compatibility (EMC), and must be installed taking into account the following technical information. ELECTROMAGNETIC EMISSIONS Manufacturer's guide and statement – electromagnetic emissions The VS unit is designed to operate in electromagnetic environments specified below.
  • Page 46 Manufacturer's guide and statement – electromagnetic immunity The VS unit is designed to operate in electromagnetic environments specified below. The client or user must ensure that it is used in such environments Immunity test Compliance Electromagnetic environment guide Conducted immunity 3Vrms 150kHz to 80MHz Portable and mobile RF communication devices IEC/EN61000-4-6...
  • Page 47 Recommended separation distances between the VS unit and mobile and portable radio communication devices The VS unit is designed to operate in an electromagnetic environment where RF irradiate disturbance is under control. The VS unit's client or operator can contribute to prevent electromagnetic interference by ensuring a minimum distance between it and mobile and portable RF communication devices (transmitters), as recommended below, in relation to the maximum output strength of the radio communication devices.

  • Page 48: Warning Tags

    2.1.7 Warning tags Warning tags relative to residual risks are applied as detailed in Figure 2. Figure 2 – Labelling design POSITION DENOMINATION "Warning - hot surface" tag "Be careful with hands" tag "PED EC" group tag "Autoclave EC" tag "Read instructions + Device including an RF transmitter"...

  • Page 49: Table Of Symbols

    Table Of Symbols Symbols Installed On The Machine Warning - hot surface Be careful with hands Equipotential terminal Warning - risk of electrical shock Unload side door opening/closing Turn On/Off the machine Unlock door to technical compartment load side and unload side EC mark issued by notified agency: 0051 identifies IMQ EC mark issued by notified agency:...

  • Page 50: Characteristics Of Storage And Conservation

    Characteristics of storage and conservation The Steelco VS series sterilization autoclaves must be stored in closed areas with the following characteristics :  2000 m Altitude (max.) Relative humidity 5% to 85% Temperature 0 to + 60 °C Time 12 month Table 3 –...

  • Page 51: Number Of Doors

    2.5.2 Number of doors The autoclave can be equipped with one door (Single Door Models) or two (Double Door Models). 2.5.3 Technical Compartment The technical compartment can be placed either to the right or the left of the chamber. This request must be made during negotiation of the contract.

  • Page 52: Operator Guide

    50° C.  The use of mobile phones or other devices that emit radio frequency in proximity of the Steelco VS Series autoclave could affect its proper operation, and must therefore be avoided.

  • Page 53: Figure 3 - Operator Position Vs1

    RESPECT RESPECT ZONE ZONE RESPECT ZONE RESPECT IF B<80cm ZONE 80 cm else B IF B<110cm 110 cm else B Figure 3 – Operator position VS1 Figure 4 – Operator position VS12 RESPECT ZONE RESPECT ZONE IF B<180cm 180 cm else B Figure 5 –...

  • Page 54: Control System

    Control system The diagrams show the main control buttons and pilot-lights on the load side and on the sterile side of the machine: SYSTEM BUTTON HELP BUTTON MENÙ BUTTON START BUTTON CLOSE DOOR BUTTON DISPLAY TOUCH SCREEN OPEN DOOR BUTTON 0-1 BUTTON EMERGENCY BUTTON MANOVACUOMETER...

  • Page 55: Figure 7 - Sterile Side

    DISPLAY TOUCH SCREEN EMERGENCY BUTTON MANOVACUOMETER Figure 7 – Sterile side...

  • Page 56: Main Menù Page

    Main menù page By starting up the machine, after “STEELCO” label is shown, “MAIN MENU” page appears. Figure 8 – Main menu This page allows several operations (starting up a sterilization cycle, going to maintenance menù, etc.), as described in the following paragraph.

  • Page 57: Keyboards

    3.3.2 Keyboards The control system uses two types of keyboards: a keyboard to write texts and a numerical keyboard to insert numbers.  To write a text, push the preferred sequence of buttons and push enter “ ”. The “BS” button cancel the type before the cursor, the “DL”...

  • Page 58: Sterilization" Menu

    3.3.3 “STERILIZATION” Menu This menu allows to start each sterilization process. To start a sterilization cycle follow these points: 1 – start up the machine using the key switch on the control board ( or push “MENU’” button on the control panel if the machine is working).

  • Page 59: Figure 13 - Basic Program

    Selection” writing, it is possible to select the way of carrying out the sterilization cycle. In case, by pushing the said field, the options do not modify, it means that different options from the one previously selected are not available. The “WORK Selection”...

  • Page 60: Figure 15 - Work State

    During the whole cycle the machine goes automatically on the “WORK STATE” page. Figure 15 – Work state The main page contains, in lexicographic order, the following information: the five fields describing the state of the system the working program (in this example “VACUUM TEST”); the power source used to generate steam (in this example ”ELECT.

  • Page 61: Figure 16 - Sterilization Describe

    By pushing “PROGR.” The page describing the sterilization program in progress can be reached. Figure 16 – Sterilization describe In this page, in lexicographic order, it is possible to display the following information: The name of the program in progress; The execution characteristics of the sterilization cycle.

  • Page 62: Figure 18 - Parameters Diagram

    Push the “TREND” button to display with a diagram the data recorded by the control system and by the recording system. By using the arrows under the diagram, it is possible to move the cursor inside the diagram. It is possible to display temperature and pressure physical parameters present in the chamber (data down on the left), relevant to the point selected with the cursor.

  • Page 63: Figure 20 - Cycle Suspend

    Whether during the cycle electric power is interrupted, in the moment it starts again the system sets on the following mask: Figure 20 – Cycle suspend Pushing the “END” button the sterilizer reach the door opening conditions, pushing the “START” button the cycle start again from the beginning of the phase stopped by the interruption of electric power.

  • Page 64: Figure 22 - Alarm Describe

    Figure 22 – Alarm describe Two alarm pages are foreseen: use the arrows down on the left to move from one page to another. Once the active alarm conditions have been analysed, and the causes of the alarms eliminated, it is possible to restore the system by pushing the “RESET”...

  • Page 65: Last Cycle" Menu

    3.3.4 “LAST CYCLE” Menu To reach the “LAST CYCLE” menu push its button in the main menu. This menu allows to display and to print the information relevant to the latest cycle carried out. Figure 25 – Last cycle The available options are: SAMPLINGS: allows to print the samplings of the latest cycle establishing also the sampling interval;...

  • Page 66: Utility" Menu

    3.3.5 “UTILITY” Menu Per enter the “UTILITY” menu, push its button in the “MAIN MENU”. This menu allows to display and print the information relevant to the sterilizer and to its state, and allows to do some useful operation for the use of the printers. Figure 27 –...

  • Page 67: Figure 29 - Maintenance State

    MAINTEN. STATE: allows to display the data relevant to the latest maintenance operation. Among the data contained in the report, the following ones can be visualized: o Total number of the cycles carried out; o The date of the latest maintenance operation carried out; o The number of the cycles done in the moment of the maintenance intervention;...

  • Page 68: Figure 30 - State I/O

    Figure 30 – State I/O The state of the inlet and outlet devices is described by the “ON” or “OFF” value written near the description of the I/O ways. Push the “INGR”, “OUT1” e “OUT2” buttons to reach the pages of the inlet and outlet devices. Figure 31 –...

  • Page 69: Figure 33 - Graph. State

    The state of all inlet and outlet ways is described with a diagram in the “GRAPH. STATE” page (synoptic diagram of the appliance). Figure 33 – Graph. state PRINTER UTILITY: allows to carry out some operations on the printer from the panel. The possible operations are: o restore: resets the hardware of the printer and arrange it for functioning (with this procedure the printer is set so as to be used by the control system) ;...

  • Page 70: Maintenance" Menu

    3.3.6 “MAINTENANCE” menu The “MAINTENANCE” menu is protected by a password and only responsible personnel knowing the password can have access to it. Figure 35 – Maintenance menu The following operations can be started from the main page of this menu: “UPDATE CLOCK”: allows to modify date and time;...

  • Page 71: Figure 37 - Manual Control

    “MANUAL CONTROLS”: allows to activate by hand the outlet devices of the control system to check the functioning of motors, valves, etc. These operations are subdue to all safety conditions granting the safety of the operator. Figure 37 – Manual control Before manual controls can be used, it is necessary to activate the function by pushing the “DISABLED MANUALS”, and to set the limits for the functioning of the cavity and of the chamber by pushing their fields in the “LIMITS”...

  • Page 72: Figure 39 - Outlet Control

    Push the INGR, OUT1 and/or OUT2 buttons to display the “OUTLET CONTROL” and “INLET STATE” pages. Push the field near the description to activate a specific outlet device. The outlet device is activated only if this action is not dangerous for the operator. Figure 39 –...

  • Page 73: Figure 41 - Graph. State

    The state of all inlet and outlet ways is described with a diagram in the “GRAPH. STATE” page (synoptic diagram of the appliance). In this page it is possible to activate the several digital outlets of the control system simply clicking on their enter buttons (motors, valves, etc.).

  • Page 74: Configuration" Menu

    3.3.7 “CONFIGURATION” menu The “CONFIGURATION” menu is protected by a password and only responsible personnel knowing the password can have access to it. Figure 43 – Configuration From the main page of this menu it is possible to activate the following activities: “SYSTEM DATA”: this menu allows to define some settings of the sterilizer.

  • Page 75: Figure 45 -Temperature

    o “WORK SELECTION”: this parameter allows to choose the modes of starting a sterilization cycle. The options are:  “OPERATOR”: the work program is established by the operator next to the machine;  “SYSTEM”: the sterilizer follows the STEELCODATA driving program. The operator has only to push the start button to start the cycle without setting other data;...

  • Page 76: Figure 46 - Operators Authorized List

     “ALWAYS”: the display is turn off after a certain period of time set by the programmer; “OPERATORS”: allows to fill in the file on the operators authorized to make the sterilizer work. Figure 46 – Operators authorized list Clicking on an empty field, it is possible to insert a new operator, instead, clicking on a field with the name of an operator, it is possible to modify the data about him/her, or to erase the operator.

  • Page 77: Figure 48 - Program

    “PROGRAMS”: allows to define the “USERS” programs. Figure 48 - Program Clicking an empty field it is possible to insert a new program, while clicking on a field containing a program it is possible to modify its setting parameters. In both cases the following window appears. Figure 49 –...

  • Page 78: Characteristics Of The Phases Of The Sterilization Programs

    Figure 50 – Programs set 5. set the properties of every phase: in order to do this, push correspondingly to the fourth area Figure 51 – Properties phase set 3.3.8 Characteristics of the phases of the sterilization programs Seal control: Figure 52 –...

  • Page 79: Figure 53 - Homogenization

    o “JACKET temperature °C”: allows to set the temperature to be reached by the cavity before activating the gasket seal; o “CONTROL time”: sets the time to be waited for, before generating an alarm indicating problems in the seal system; “SEAL type”: select the type of seal used in the cycle in progress: ...

  • Page 80: Figure 54 - Sterilization

    Sterilization Figure 54 – Sterilization o “JACKET Temperature °C”: allows to set the temperature to be maintained in the cavity during the whole phase; o “CHAMBER Temperature °C”: allows to set the temperature value at which the counting of the sterilization time starts o “bar Control Pressure”: sets the pressure with which the sterilization plateau is controlled the conditions of sterilization are maintained by controlling the pressure while the temperature is capt under control for the checks necessary to the convalidation of the sterilization cycles.

  • Page 81: Figure 56 - Vacuum Test

    Vacuum Test Figure 56 – Vacuum test o “JACKET Temperature °C”: allows to set the temperature to be maintained in the cavity during the whole phase; o “Vacuum to be reached bar”: sets the vacuum value to be reached by the autoclave before the stabilization phase.

  • Page 82: Figure 58 - Cooling

    Cooling Figure 58 – Cooling o “JACKET Temperature °C”: allows to set the temperature to be maintained in the cavity during the whole phase; o “CHAMBER Temperature °C”: allows to set the temperature value at which the counting of the time for which the temperature set must be maintained starts. o “Control Pressure bar: sets the pressure with which the cooling phase is controlled.

  • Page 83: Graphs

    Graphs The following paragraph illustrates some examples of graphs referred to the standard cycles of Steelco VS Series sterilizers. Pressure refers to pressure measured in the chamber by probes PT11 or PT16, whilst temperature to chamber probes TE22 or TE27.
  • Page 84 cent.bar T°C 133.7 127.6 120.4 ADJUSTMENT ASSESTAMENTO 111.6 VACUUM TEST TEST VUOTO TIME (MINUTES) tempo (MINUTI) 12.5 15.0 17.5 20.0 22.5 -0.5 -1.0 VACUUM PROGRAMMA TEST VUOTO TEST...
  • Page 85 cent.bar T°C GRAFICO DELLA PRESSIONE GRAPHS OF PRESSURE minutes 5 minuti 133.7 127.6 120.4 GRAPHS OF TEMPERATURE GRAFICO DELLA TEMPERATURA 111.6 TIME (MINUTES) tempo (MINUTI) 12.5 15.0 17.5 20.0 22.5 -0.5 -1.0 minutes 5 minuti INSTRUMENTS PROGRAMMA PROGRAM TO 134°C STRUMENTARIO A 134 °C cent.bar GRAPHS OF PRESSURE...
  • Page 86 cent.bar GRAPHS OF PRESSURE GRAFICO DELLA PRESSIONE T°C 133.7 minutes 20 minuti 127.6 120.4 GRAPHS OF TEMPERATURE GRAFICO DELLA TEMPERATURA 111.6 -0.5 -1.0 TIME (MINUTES) tempo (MINUTI) RUBBER PROGRAMMA PROGRAM TO 121°C GOMME A 121 °C The graph shown here are for information purposes only...

  • Page 87: Pc Interface

    PC INTERFACE The system provides an Ethernet channel of communication. Through this channel is possible: download the complete data of the last cycle; view the machine status in real-time; remote programmability. INTERFACE LAST CYCLE DATA Events Samples Temperature ETHERNET software external SUPERVISION PLC 1...

  • Page 88: Alarms

    4. ALARMS The machine's proper operation is ensured by scrupulous design as well as continued system control of the process parameters and machine statuses. With the term alarm it is intended that type of malfunction signal that derives from the process control. The appearance of a signal of this type means that the current process is immediately interrupted;...
  • Page 89 If the Problems in the control of PLC maintenance lock!!! problem persists, contact operator Steelco customer service Reset the alarm, and repeat Qualified Anterior door The anti-crushing plate on the load the operation of close and maintenance...
  • Page 90 If the control plc maintenance Problems in the autoclave problem persists, contact operator (xob10) management program Steelco customer service Switch off and switch on Trouble with Qualified again the machine. If the control plc maintenance Problems in the autoclave...
  • Page 91 Steelco customer service. Switch off and switch on The probe does not read or gives again the machine. If the no data to the PLC.
  • Page 92 Incorrect data read from the PLC pressure PLC. If the problem persists, maintenance pressure switch operator recording contact Steelco customer service Check the settings of the cycle and the sliding guides. Trained Command front The door will not open even...
  • Page 93 Steelco customer service. Switch off and switch on again the machine. If the problem persists verify the The transducer does not read or transductor, the converter gives no data to the PLC.
  • Page 94 Breaking pneumatic valve steam or engine. If the problem maintenance online absence of steam in-line operator persists, contact Steelco customer service Verify: 1) the presence of water in the feed circuit upside the appliance; Signalises there is no water in the 2) that the interceptions feed line.
  • Page 95 Reset the normal state Emergency Signalises the emergency button Sterilisation unlocking the emergency intervention has been pushed. operator. button. The machine can not load water. Verify: Possible causes: 1) the fuses or the 1) the pump safety devices thermal device of the upside the machine have water pump;...
  • Page 96 Temperature vacuum pump or high and corresponding relay. If maintenance pump vacuum thermal release vacuum pump the problem persists, contact operator Steelco customer service Inconsistency between the Clean the sensors and Qualified Mismatch water maximum and minimum levels of control devices level. If the...
  • Page 97 The machine can not heat the cavity in the time set before. Possible causes: 1) the steam delivery plant is Verify: closed; 1) that the steam 2) wrong data setting; delivery pipes are 3) problem in the circuit open; taking steam to the cavity; 2) that the data set are 4) the water in the generator is correct;...
  • Page 98 hydraulic circuit. comparing the values read by the system to those read by the dial manometers; 5) the efficiency of the valve supplying water o the liquid ring of the vacuum pump; 6) the condition of the gasket and, if necessary, replace it.
  • Page 99 The sterilization phase lasted 1) control if any alarm longer than the MAX time set. arose during the Possible causes: phase; 1) during the phase the 2) try to start the cycle 1,2) electricity missed for a again. If the problem Sterilisation Out of period;...

  • Page 100: Table 4 - Alarms

    test!! machine can not keep the leak control the efficiency of the maintenance operator under the limit set before. related circuit valves. Possible causes: 1) the measuring system is not calibrated; 2)leak in the hydraulic circuit Conditioning TIME-OUT rebalancing weather. Check and if necessary Qualified opening time...

  • Page 101: Maintenance

    (and who must be trained to carry out the aforementioned operations); a qualified maintenance technician who is directly employed by Steelco S.p.A. or a technician employed by an Steelco S.p.A.. dealer for technical assistance or a technician employed by the organization that possesses the unit who has attended an appropriate training course held by Steelco S.p.A..
  • Page 102 FREQUENCY ACTION PERFORMED BY EVERY 600 replace the seals: remove the seal, clean Qualified maintenance CYCLES or the groove accurately with a scotch-brite technician EVERY 180 cloth or with a cloth dipped in denatured DAYS alcohol, install the new seal in the groove after sprinkling it with talcum powder or suitable lubricating oil.

  • Page 103: Periodic Cleaning

     The maintenance operations on the safety components indicated in “Table 6 – Safety devices” must only be carried out by maintenance technicians qualified by Steelco S.p.A.. Periodic Cleaning 5.1.1 External paneling cleaning Stainless steel owes its resistance to a protective oxide film which, when exposed to air, forms at the molecular level on its surface.

  • Page 104: Sterilization Chamber Cleaning

    5.1.2 Sterilization chamber cleaning Cleaning of the sterilization chamber must be carried out when the unit is turned on and the entire autoclave is cold. The jacket is not heated after the power on until the program is not selected or started. I Carefully follow the below instructions: 1.

  • Page 105: Safety Devices

     The maintenance operations on the safety components indicated in “Table 6 – Safety devices” must only be carried out by maintenance technicians qualified by Steelco S.p.A..

  • Page 106: Procedure To Extract The Load In Emergency

    10. Then proceed with unloading the material, using appropriate protection against high temperatures that may be present. 11. Remove the keys from the selectors. 12. Close the inspection door of the technical compartment and call the Steelco S.p.A.. support  This procedure must be carried out by the supervisor only...

  • Page 107: Treatment And Conservation Of Sterilized Material

    6. TREATMENT AND CONSERVATION OF STERILIZED MATERIAL Treatment of Materials Before Sterilization The sterilization process can be deemed as effective, reliable and repeatable provided the material to be first suitably treated and then arranged properly and tidily inside the sterilization chamber. Indeed, it is important to underline that organic residues or deposits of substances used in medical practice are inevitably receptacles for micro organisms, and can hinder the contact of steam with the walls of the instrument, inactivating, at least locally, the lethal process that is usually guaranteed by...

  • Page 108: Arrangement Of The Load

    metal instruments that may be present in the sterilization chamber Arrangement of the load To achieve the best effect of the sterilization process, and to conserve the material over time by extending its life cycle, follow the instructions below. Arrange instruments of different metals (stainless steel, tempered steel, aluminium, etc.) in different containers or keep them separated from one another;...

  • Page 109: Conservation Of Sterilized Material

    Conservation of sterilized material Sterilized material must be suitably treated and conserved to continue being sterile over time, until it is used. Improper conservation may lead to re-contamination of the material. This causes a dangerous situation because the alternative is to use re-contaminated material (most times unconsciously), placing the receiver in a situation of risk, or to repeat the sterilization cycle (with inevitable waste of time and resources) For best use of the sterilized material, observe the following instructions:...

  • Page 110: Printouts

    7. PRINTOUTS Printout management The documentation that the control system and registration system release is a document that allows a thorough and precise assessment of the outcome of the sterilization process : validation of each process can be carried out in accordance with the provisions of the existing rules . The system is configured to print the chart and the events that occurred during the sterilization cycle and are detected by the recording system ;...

  • Page 111: Table 7 - Available Reports Content

    Printout management is greatly important to identify the status of the process and machine. The various types of printouts necessary are detailed and described below. Report Contents Complete cycle The control system allows the reprint of the report of the last ended cycle Complete version.

  • Page 112: Complete Cycle Report

    Complete cycle report The autoclave, at the end of each cycle, automatically prints the report of the just ended cycle. The following is an example of the complete cycle report. The report contains:  Machine identification  Programme name  Cycle number ...

  • Page 113: Table 8 - Analogical Data For Report

    Code Description Unit of measure PT11 Chamber pressure mbar(A) PT16 Chamber reference pressure mbar(A) TE22 Chamber temperature °C TE27 Chamber reference temperature °C TE23 Air chamber temperature °C TE28 Air detector temperature °C calculated for TE22 temperature min. Table 8 – Analogical Data for report ...

  • Page 114: Cycle Report Data

     The analogical signals represented into the graphic depend on the settings made at the “Printer Option” screen. Cycle Report Data This form of report contains some of the part of the complete form. See the par. 7.2 Complete cycle report at page 112 for the description of the parts.

  • Page 115: Glossary

    8. GLOSSARY Term Description CanBus Acronym for Controller Area Network, i.e. a network that connects the control devices and I/O devices into automation system. Acronym for Continuous Function Chart, i.e. a type of function programming with a continuous flow chart. It expresses the number of minutes of sterilization equivalent to a 121°C sterilization.

  • Page 116: Attachment 1 P&I Drawing

    9. ATTACHMENT 1 P&I DRAWING...

  • Page 117: Attachment 2 Electrical Diagram

    ATTACHMENT 2 ELECTRICAL DIAGRAM...

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