Smeg B-One User Manual
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Smeg B-One User Manual

Steam sterilizer
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B-One
STEAM STERILIZER
English user manual

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Summary of Contents for Smeg B-One

  • Page 1 B-One STEAM STERILIZER English user manual...
  • Page 3 STEAM STERILIZER User manual Dear Doctor, We would like first and foremost to thank you for having selected a B-One autoclave. Please note that the manufacturer is at your disposal for any further information and explanations regarding this equipment. We also would like to remind you that this manual must be read carefully before any equipment use to ensure proper autoclave use.
  • Page 4 The machine must only be used by specifically trained person. It is Smeg task to train the designated users when the machine is installed. Smeg declines all liability for malfunctioning or accidents due to the machine having been used by untrained persons.
  • Page 5 All drawings and any other document contained in this manual are property of the manufacturer, who reserves all rights its rights. Said drawings and documents cannot be conferred to third parties. Partial or complete reproduction of text or illustrations is strictly prohibited. Revision n.1 User Manual B-One Edition: 04/2009 Page 5 of 52...

  • Page 6: Table Of Contents

    DATE AND TIME .................. 34 DATE AND TIME FORMAT ..............35 PASSWORD ..................35 DISPLAY....................36 SD MEMORY..................36 PRODUCT INFO................... 36 6.10 MAINTENANCE................. 36 6.11 SERVICE ................... 36 Revision n.1 User Manual B-One Edition: 04/2009 Page 6 of 52...
  • Page 7 BACTERIOLOGICAL FILTER REPLACEMENT PROCEDURES..45 MECHANICAL PARTS LUBRICATION ..........46 MAINTENANCE OPERATIONS SUMMARY TABLE......46 ACCESSORIES..................47 10.1 PROVIDED ACCESSORIES ............. 47 10.2 OPTIONAL ACCESSORIES UPON REQUEST ........ 47 Revision n.1 User Manual B-One Edition: 04/2009 Page 7 of 52...
  • Page 8 Wait for a Service Assistance technician to open packaging and verify that supply complies with order specifications and that there are no clear signs of damage. Promptly inform Smeg S.p.A. or area representatives of any damage or missing parts. Do not proceed with installation in case of said damage or missing parts.

  • Page 9: Proper Use

    1 PROPER USE B-One is a steam autoclave which can be used for the sterilization of medical and dental instruments, in health or beauty centres and in veterinary practices. As a small autoclave, this device is categorised as a class IIA medical device (according to directive CE/93/42 classification criteria).

  • Page 10: Technical Features

    50% at temperatures of 40° C Altitude max 1000m 66 db Max Noise emissions Chamber – max pressure 2.6 bar 2.6 bar Generator and jacket – max pressure Revision n.1 User Manual B-One Edition: 04/2009 Page 10 of 52...
  • Page 11 REFERENCE NORMS Product norm UNI EN 13060 Safety norm UNI EN 61010-1; UNI EN 61010-2-041 Directives DIRECTIVE 93/42/CE “MEDICAL DEVICES” DIRECTIVE 2004/108/CE “ELECTROMAGNETIC COMPATIBILITY” Revision n.1 User Manual B-One Edition: 04/2009 Page 11 of 52...

  • Page 12: Installation

    B-ONE is factory tested. Product installation and maintenance must be performed by authorised Smeg technical personnel. Smeg declines all responsibility in the event of installation or maintenance performed by unauthorised personnel. Set B-One on a flat surface. In addition to the external autoclave dimensions, consider an extra bulk in depth for connections located on the rear side, approx.

  • Page 13: Safety Warnings

    Do not install B-One next to sinks or other sources of humidity. Contacts with water can generate short circuits and damage to electrical and electronic parts. Keep equipment away from heat sources. Make sure that the power supply cable is not bent and that nothing has been placed on top of it and that the electrical socket can be easily reached.

  • Page 14: Presentation

    Main switch – equipment power supply. FRONT HYDRAULIC CONNECTIONS The three front hydraulic connections are accessible only when the door is open Load connection demineralised water tank Revision n.1 User Manual B-One Edition: 04/2009 Page 14 of 52...

  • Page 15: Devices On The Rear Panel

    Quick connect for tank loading demineralised water from can (can only be set by authorised technical personnel) Quick connect for tank discharge of used water Quick connect for DEMI-One water purifier loading Revision n.1 User Manual B-One Edition: 04/2009 Page 15 of 52...

  • Page 16: Machine Operation

    Flashing blue ring: cycle in progress • Fixed red ring: alarm compromising cycle implementation • Fixed violet ring: warning, operator intervention required (tank filling/emptying, memory card insertion) • Ring off: machine off Revision n.1 User Manual B-One Edition: 04/2009 Page 16 of 52...

  • Page 17: Turn-On

    The autoclave switches on when the ON/OFF button (blue general switch) is pressed. The SMEG logo appears on the display and a BEEP sound will be activated. The autoclave carries out a routine initial check. Any irregularities will be shown on the display.
  • Page 18 14 – “escape” icon– on the lower right of the display, this allows the user to return to the previous screen. If the door is set for closing, B-One proceeds with automatic closing. The display will read "cycle in progress".

  • Page 19: Available Cycles - Sterilization And Tests

    Cycle for sterilization of solid, unbagged FAST 134° C 4:00 2:00 instruments, not suitable for hollow bodies, type N 134° C 22:00 9:00 Prion cycle PRION Revision n.1 User Manual B-One Edition: 04/2009 Page 19 of 52...

  • Page 20: Preheating

    It is possible to select and activate a sterilization cycle even from the stand-by mode. The machine will then restart preheating and will autonomously manage cycle turn-on. Revision n.1 User Manual B-One Edition: 04/2009 Page 20 of 52...

  • Page 21: Shutdown

    Once procedure resetting has been completed, the machine will be ready for a new sterilization cycle to be turned on. TANK MANAGEMENT fig. 17 – front connections for water load/discharge The B-One sterilizer is equipped with two tanks: Revision n.1 User Manual B-One Edition: 04/2009...

  • Page 22: Loading Tank Filling - Demi

    This is recommended if, for example, a limited quantity of demineralised water is available. when the machine has completed the loading of available water, it is best to interrupt the process to prevent that pumps work "dry" and thus become damaged. Revision n.1 User Manual B-One Edition: 04/2009 Page 22 of 52...
  • Page 23 - it is possible to top up the tank via the auxiliary input located under the top level (sheet metal plate cover, as seen in the following image). Report the loading system malfunction to Smeg technical assistance before carrying out the procedure described below.

  • Page 24: Demineralised Water Quality Control

    5.8.2 DEMINERALISED WATER QUALITY CONTROL The B-One autoclave is supplied with an integrated system for input water conductivity verification. Each time demineralised water is loaded, the autoclave verifies if loaded water is suitable for use. The user will be notified if water is not suitable: the corresponding icon on the display signals that the loaded water does not have suitable features for sterilization, and the lit ring on the knob will turn violet.

  • Page 25: Manual Draining Of Loading Tank Water

    During sterilization, used water is collected in a suitable tank ("discharge tank"). If the level exceeds the maximum allowed level, the machine will warn the operator with a message (“DISCHARGE TANK FULL"). fig. 21 – “DISCHARGE TANK FULL” warning screen Revision n.1 User Manual B-One Edition: 04/2009 Page 25 of 52...

  • Page 26: Automatic Draining

    If necessary, tank draining can be interrupted by pressing the knob a second time. 5.8.6 AUTOMATIC DRAINING When a free discharge connection is set near the machine, authorised Smeg technical personnel can configure discharge in such a way that it is carried out automatically, without the user needing to manually manage operations.

  • Page 27: Automatic Supply From An External Can

    In both modes, B-One manages its water supply via a connection located at the rear. 5.8.8 AUTOMATIC SUPPLY FROM AN EXTERNAL CAN Authorised Smeg technical personnel can configure the B-One in such a way that supply water is withdrawn from an external can.

  • Page 28: Cycle Interruption

    24 – “STOP” icon for forced cycle interruption Once the icon has been selected, the user will be however be asked for cycle interruption confirmation. Revision n.1 User Manual B-One Edition: 04/2009 Page 28 of 52...

  • Page 29: Cycle Completed

    5.12 PRINTER CONNECTION The printer can be connected to the RS232 port located at the rear. The machine recognises installation and immediately activates printing of the cycle in progress. Revision n.1 User Manual B-One Edition: 04/2009 Page 29 of 52...

  • Page 30: Forced Interruption

    Sterilization cycles interrupted by means of the "STOP" icon or due to a black-out are not to be considered valid. material in the chamber is not sterile. Revision n.1 User Manual B-One Edition: 04/2009 Page 30 of 52...

  • Page 31: User Recognition

    6. Repeat this aforementioned procedure for each character making up the password 7. Once password entry has been completed, use the knob to confirm by selecting the icon at the lower right. Revision n.1 User Manual B-One Edition: 04/2009 Page 31 of 52...

  • Page 32: Service Menu - Settings

    The internal memory capacity is limited and cycles will eventually be overwritten when memory is full. In addition to this internal memory, the B-One is equipped with a data back-up system on the "SD" type memory card. Data back-up on the SD card is carried out automatically if the memory card is present and correctly installed.
  • Page 33 30 – data is archived already ordered on the SD card (ex: in the image: “12345789” is relative to the equipment series numb., “090130” is the folder relative to cycles performed on 30 January 2009, while “00022” is the 22nd cycle performed on the autoclave) Revision n.1 User Manual B-One Edition: 04/2009 Page 33 of 52...

  • Page 34: Preheating - Wake

    Using the knob, it is possible to change the following, in order: hours, minutes, month, day and year, pressing once each time to pass to the next setting. The previous screen will be returned to after the year is modified. Revision n.1 User Manual B-One Edition: 04/2009 Page 34 of 52...

  • Page 35: Date And Time Format

    The administrator can enter the name and other identifying information together with the password, and said information will appear in sterilization cycle reports. Some menu headings for assistance operations require password entry. Revision n.1 User Manual B-One Edition: 04/2009 Page 35 of 52...

  • Page 36: Display

    B-One is equipped with an "SD" memory card data archive system. Select this setting to manually save cycles memorised in the archive on the SD support, or to format the SD card (recommended upon first use on the B-One with a new memory card ).

  • Page 37: Door Closing

    34 – Screen with door closing request, select the "return" icon to return to the previous screen Once the door has been set for closing, B-One will proceed with automatic closing. The door can be unlocked by returning to the main screen and selecting the "lock" icon at the lower left of the display.

  • Page 38: Steam Sterilization

    STERILIZATION MONITORING – B&D AND HELIX TESTS The purpose of these tests is to ascertain sterilization efficiency. B-One carries out B&D (Bowie-Dick) and Helix tests. The B&D test is performed with a "standard test-pack" (ref. Norm EN 867-5 “Non- biological systems for use in sterilizers”), to be set inside the empty autoclave according to test manufacturer instructions.

  • Page 39: Preparation Of Objects For Sterilization

    INSTRUMENT CLEANING Instruments must be cleaned, free from any blood or swab residue, etc. Use Smeg instrument washers for instrument treatment, or else detergent solutions and distilled water according to instrument manufacturer instructions. Separate instruments by the type of material they are composed of, avoiding any direct contact between different material instruments.
  • Page 40 Place a chemical indicator test in each tray. Do not overload or overlap trays. Always use supplied tray supports. Max recommended naked instruments load: 3.5kg Max recommended bagged instruments load:1.5kg. Revision n.1 User Manual B-One Edition: 04/2009 Page 40 of 52...

  • Page 41: Errors And Alarms

    3. If the error persists: switch off the machine, wait a few seconds, switch it back on to resolve problems involving an electronic system reset Revision n.1 User Manual B-One Edition: 04/2009 Page 41 of 52...
  • Page 42 Interface board – communication error between the interface and the cpu board. SD card not connected. SD card format not known. SD card full. Cpu board – jumper off Demi switch position not correct Revision n.1 User Manual B-One Edition: 04/2009 Page 42 of 52...
  • Page 43 In this case, remove object and check that front lining has not been damaged. Pressure recovery phase during fractioned vacuums. Error may involve function of the machine solenoid valve. Keep in mind that Revision n.1 User Manual B-One Edition: 04/2009 Page 43 of 52...
  • Page 44 Error may involve function of the machine solenoid valve. Keep in mind that solenoid valve malfunction is generally caused by unsuitable water, or water whose parameters are not optimal. See recommended values in this manual. Revision n.1 User Manual B-One Edition: 04/2009 Page 44 of 52...

  • Page 45: Maintenance

    9 MAINTENANCE B-One requires proper use, careful routine cleaning and regular maintenance by Service Assistance. Remember to clean all parts with a cloth moistened with water or neutral detergent: non- corrosive and non-abrasive soap. Do not use ethyl alcohol. Do not use jets of water aimed directly on the machine as they could cause dangerous infiltrations on the electrical equipment, compromising B-One functions.

  • Page 46: Mechanical Parts Lubrication

    Failure to carry out maintenance, interventions by unauthorised personnel, replacements with non-original components can all result in the forfeiture of the official warranty issued by the manufacturer and releases Smeg S.p.A. of any responsibility. MAINTENANCE OPERATIONS SUMMARY TABLE DAILY MAINTENANCE Clean external and internal surfaces.

  • Page 47: Accessories

    Wire tray in stainless steel, dimensions 288 x 188 x 18 mm, square mesh 12x12 mm Bacteriological filter (refill) PRINT-One countertop thermal printer, RS-232 serial port DEMI-One water purifier for autoclave input water Revision n.1 User Manual B-One Edition: 04/2009 Page 47 of 52...
  • Page 48 PRESENT ERROR REPORT TABLE ERROR TYPE (ex. CONDITIONS AT TIME OF ERROR DATE E1-16-16) (type of cycle in progress, number of completed cycles, surrounding conditions) Revision n.1 User Manual B-One Edition: 04/2009 Page 48 of 52...
  • Page 49 ERROR TYPE (ex. CONDITIONS AT TIME OF ERROR DATE E1-16-16) (type of cycle in progress, number of completed cycles, surrounding conditions) Revision n.1 User Manual B-One Edition: 04/2009 Page 49 of 52...
  • Page 50 Information and Assistance for SMEG INSTRUMENTS DIVISION products Our Sales Office staff can provide you with information on prices and offers. Our Technical Assistance Office can provide you with information for proper equipment operation and put you in contact with a nearby authorised Assistance Office.
  • Page 51 Revision n.1 User Manual B-One Edition: 04/2009 Page 51 of 52...
  • Page 52 Smeg SpA Via L. da Vinci, 4 Instruments Division Via Circonvallazione Nord, 36 – 42016 Guastalla (RE) Tel +39 0522 8211 – Fax +39 0522 821 592 E-mail: instruments@smeg.it – www.smeg-instruments.com...

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