D FASTER CytoFAST Top Operating And Maintenance Manual
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D FASTER CytoFAST Top Operating And Maintenance Manual

Vertical laminar airflow cabinet for cytotoxic drugs
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Commercial office:
Via Merendi, 22
20010 Cornaredo (MI)
Tel. +39.02.93.991.92
Fax. +39.02.93.991.608
E-mail: info@faster.dgroup.it
OPERATING AND
MAINTENANCE MANUAL
CytoFAST Top
VERTICAL LAMINAR AIRFLOW CABINET
FOR CYTOTOXIC DRUGS
00055EN - Rev. 10 – 12/2011 – (ORIGINAL INSTRUCTIONS)

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  • Page 1 Commercial office: Via Merendi, 22 20010 Cornaredo (MI) Tel. +39.02.93.991.92 Fax. +39.02.93.991.608 E-mail: info@faster.dgroup.it OPERATING AND MAINTENANCE MANUAL CytoFAST Top VERTICAL LAMINAR AIRFLOW CABINET FOR CYTOTOXIC DRUGS 00055EN - Rev. 10 – 12/2011 – (ORIGINAL INSTRUCTIONS)

  • Page 2: Table Of Contents

    D:GROUP Company CONTENTS GENERAL .................................. 2 INSTALLATION ................................3 INSTRUCTIONS AND CHECKS ON DELIVERY ....................3 INSTALLATION REQUIREMENTS........................3 ELECTRIC/GAS CONNECTIONS INSTALLATION OF THE WORK SURFACE ......... 5 OPERATION PRINCIPLES ............................7 OPERATION ................................8 SCOPE ................................8 CONTROL AND REGULATION SYSTEMS ....................... 8 REMOTE SIGNALS (OPTIONAL) ........................

  • Page 3: General

    70% laminar flow recirculated air and 30% extracted air with prior HEPA filtering. Suitable for the treatment of class CDC-1/2/3, DHSS-C/B1/B2 group 1,2,3 microorganisms as per D.L. 81/08 “Safety in the working environment” and wherever a product-personnel-environment cross- protection is required.

  • Page 4: Installation

    D:GROUP Company INSTALLATION INSTRUCTIONS AND CHECKS ON DELIVERY Considering the critical nature of the use of the CytoFAST Top cabinet and the need to keep it in optimum condition, installation is very important. CytoFAST Top Biohazard cabinets are positioned on a pallet, wrapped in an extensible film and contained in a package of multi-layer strapped cardboard.
  • Page 5 D:GROUP Company Thimble method example THIMBLE LEGENDA: 1. Exhaust air from the cabinet. 2. Air from the environment. ÷ 3. Bleed Air (100 200 m /h more than the exhaust air flow rate from the cabinet) to a dedicated exhaust...

  • Page 6: Celectric/Gas Connections And Installation Of The Work Surface

    D:GROUP Company ELECTRIC/GAS CONNECTIONS and INSTALLATION OF THE WORK SURFACE The electrical connection of the CytoFAST Top Biohazard cabinet is made by connecting the power cable located on the upper of the right side of the cabinet to a suitable power point (see technical table) . When the cabinet is connected, the green light on the control panel switches on (see chapter 4D).
  • Page 7 D:GROUP Company Techincal Features Table Description Unit CytoFAST Top 209 CytoFAST Top 212 CytoFAST Top 215 CytoFAST Top 218 Overall Dimensions (L x H x P) 1015x2290x785 1320x2290x785 1625x2290x785 1930x2290x785 Usefull dimensions (L x H x P) 885x660x580 1190x660x580...

  • Page 8: Operation Principles

    D:GROUP Company OPERATION PRINCIPLES The following are the working principles of the CytoFAST Top cabinet : the pressurized air pushed into the plenum of the main motor-fan passes through the absolute filter and then downwards, in laminar flow, into the working chamber. From here, through the slots of the work...

  • Page 9: Operation

    D:GROUP Company OPERATION SCOPE The vertical laminar airflow cabinet CytoFAST Top is manufactured in compliance with international standards for the protection of the material, the operator and the environment against biological (Class II) and cytotoxic hazards and is suitable for the manipulation of low- and middle-risk pathogenic agents CONTROL AND REGULATION SYSTEMS The CytoFAST Top cabinet is provided with an automatic regulation system to keep the airflow speed (0.4...

  • Page 10: Cremote Signals (Optional)

    D:GROUP Company REMOTE SIGNALS (OPTIONAL) The electronic control board can be improved adding the following optional features: Ventilation status (ON/OFF) It is possible to obtain a 12 Vdc output to connect a led light or alternatively a Normally Open voltage free contact to be connected to an external circuit.

  • Page 11: Dsymbols Of The Control Panel

    D:GROUP Company SYMBOLS of the CONTROL PANEL List and description of all the symbols and controls of the control panel: 9 10 MAIN SWITCH: Position "0" in the "0" position, the green light of the mains voltage is on (3); the LCD displays the model name "CytoFAST Top".
  • Page 12 D:GROUP Company 7 LIGHT This switches on the fluorescent light; when enabled, the display shows "Light on". Switching on the fluorescent light automatically the U.V. lamp switches off. 8 UP/DOWN ARROWS Use the arrow keys to scroll the menu, to program changing parameters and to put in the password.
  • Page 13 D:GROUP Company Operating Time: Shows the operating time of the cabinet from the moment when the main switch is positioned on "I" The LCD will display (for example) "WORK TIME=XXXXXh”. This value cannot be reset. 12 SPEED REDUCTION By pushing the corresponding red key the password (the same of start) is requested.
  • Page 14 D:GROUP Company 15 MUTE The red alarm LED lights up when an alarm condition occurs, which is shown also by the message appearing on the LCD. By pushing "MUTE" the alarm stops sounding (only if the key is enabled).

  • Page 15: Emanagement And Programming Of Residual Lifetime

    D:GROUP Company MANAGEMENT AND PROGRAMMING OF RESIDUAL LIFETIME Get access to operator menu when the cabinet is in stand-by pressing “ESC” [9] together with “UP arrow” [8] keys (password). The following diagram shows the organization of “OPERATOR MENU” By pressing “SET” [10] you can either go to the highlighted entry or confirm data entry while by pressing “ESC” [9] you go back to the beginning...
  • Page 16 D:GROUP Company TIMER (countdown): use "UP/DOWN arrow" keys [8] to scroll the operator menu select “TIMER SET UP.” and press "SET" [10] key; the display will show: TIMER SET UP SET UP hh:mm input the desired time and press SET [10] to confirm...
  • Page 17 D:GROUP Company UV PROGRAMMING: use "UP/DOWN arrow" keys [8] to scroll the operator menu select “UV PROGRAMMING” press "SET" [10]; and the display shows: UV LIGHTING LENGTH SET UP hh:mm input the desired time for the UV cycle and press SET [10] to confirm the display shows: .UV PROGRAMMING...
  • Page 18 D:GROUP Company LANGUAGE SELECTION use "UP/DOWN arrow" keys [8] to scroll the operator menu select “LANGUAGE” and press "SET" [10] key; the display will show: LANGUAGE English With the “up and down arrow” keys select the desired language (Italian, English, French, German, Spanish).
  • Page 19 D:GROUP Company DISPLAY OF HISTORICAL FILES use "UP/DOWN arrow" keys [8] to scroll the operator menu select “HISTORY VIEW” and press "SET" [10] key; the display will show: use "UP/DOWN arrow" keys to scroll through the list of the possible troubles happened . The list is in chronological order and contains up to 64 voices To conclude programming, press ESC”...

  • Page 20: Fdisposal Of Wastes And Contaminated Materials

    D:GROUP Company DISPOSAL OF WASTES AND CONTAMINATED MATERIALS DISPOSAL OF ELECTRIC AND ELECTRONIC DEVICES NFORMATION FOR UROPEAN NION USER This symbol on the device means that when it needs to be disposed, it must be handled separately from urban waste.

  • Page 21: Limitations

    D:GROUP Company LIMITATIONS PRECAUTIONS for the correct use of the cabinet Listed below are the most important guidelines to be followed and the main substances to be avoided to ensure the correct use of the CytoFAST Top cabinet: NEVER USE chlorine-based substances (e.g. sodium hypochlorite) as they are corrosive for the metal structure of the cabinet, and in particular for stainless steel parts.

  • Page 22: Operating Procedures

    D:GROUP Company OPERATING PROCEDURES PRELIMINARY CHECKS Before carrying out any type of work, the following conditions should be verified: that the cabinet power cable is connected to a 220-230V-50Hz outlet that all alarm lights are off that the work area inside the cabinet is free from materials used during the previous session.

  • Page 23: Maintenance

    D:GROUP Company MAINTENANCE INSTRUCTIONS FOR DAILY CLEANING OF CytoFAST Top (by users) Clean the outside of the CytoFAST Top cabinet, made of varnished iron-carbon sheet steel, using a damp cloth soaked in soapy water or some other commonly available products for varnished metal surfaces.

  • Page 24: Binstructions For The Fumigation/Sterilization Of Biologic Safety Cabinets

    D:GROUP Company INSTRUCTIONS FOR THE FUMIGATION/STERILIZATION OF BIOLOGIC SAFETY CABINETS Procedure: For gas disinfection, formaldehyde is evaporated in the tightly sealed sample chamber. The quantity of the formaldehyde used depends on the sample chamber volume of the cabinet version to be disinfected (see Technical Data).
  • Page 25 D:GROUP Company Picture 1 Picture 2. 00055EN Rev.10 – 12/2011...
  • Page 26 D:GROUP Company Post-fumigation cleaning Having performed fumigation, the manipulation of the filters is safe: however, this manipulation should be carried out by technicians wearing protective gloves and clothing. Before using the cabinet again any possible remains of the foregoing procedure of vaporization and relevant neutralization (which can show, for example, as white dust) must be removed from the work chamber.

  • Page 27: Creplacement Of Hepa Filters (By Technical Assistance Personnel)

    D:GROUP Company REPLACEMENT OF HEPA FILTERS (by technical assistance personnel) Important: before replacing HEPA filters, it is absolutely necessary that: if pathogens have been manipulated, the cabinet must be decontaminated and the user must issue a sterilization certificate to the personnel before the start of the operation.

  • Page 28: Dreplacement Of Motor-Fans (By Technical Assistance Personnel)

    HEPA filters under the work surface are changed. Having replaced filters, proceed with the control of the motor-fan speed and if considered necessary, proceed to a test with a particle counter and possibly a D.O.P. test. For these operations, contact your local distributor.

  • Page 29: Ereplacement Of Fluorescent Lamps (By User)

    D:GROUP Company Replacement of exhaust motor-fan (see diagram for maintenance operations par. 13A): Switch off the cabinet and disconnect it from the mains Proceed as indicated in sub-section "Replacement of HEPA filters", points 2, 3 and 4. 3. Rotate both fastening threaded bars (12) to lift exhaust plenum-motor group (13) and unlock HEPA filter (14).

  • Page 30: Gspare Parts List

    BIOH-P power card V30000005000 Microprocessor Keyboard V50000000170 DDM 10/8 220V-600W Motor-fan V50000000290 DDM 10/8 220V-550W Motor-fan V50000000070 DDM 133-190 exh. motor-fan (only D version) V50000000900 Small Fan diam.154 for Anemometer V50000000910 Big Fan diam.200 for Anemometer V50000100130 Exhaust HEPA filter 350x610x69 V50000100230...

  • Page 31: Troubleshooting - Probable Causes Of Malfunctions

    D:GROUP Company TROUBLESHOOTING - PROBABLE CAUSES OF MALFUNCTIONS PROBLEM CAUSE REMEDY Cabinet does not work - Power outage upstream from the - Check the voltage input to the cabinet cabinet - Electronic board out of order - Replace PCB...
  • Page 32 D:GROUP Company PROBLEM CAUSE REMEDY During work, an alarm sounds, the The exhaust fan is out of order above-mentioned laminar airflow works regularly, problem “Alarms: low barrier and the velocity of the protective velocity”. barrier is reduced by about 30%.

  • Page 33: Monitoring System

    D:GROUP Company MONITORING SYSTEM ALARM OR ERROR MESSAGE DESCRIPTION Min. LAF Alarm Airflow speed in the work chamber under minimum threshold value Min. BARR Alarm Insufficient air suction from the front aperture LAF Triac Failure Too fast and uncontrollable main motor-fan (LAF)

  • Page 34: Technical Specifications

    Work surface AISI 304 stainless steel, located under the work surface Spillage tray HEPA filters, tested with D.O.P. fumes; efficiency of over 99.999% Absolute filters (main/exhaust) for particles of 0.3 micrometres. Under the work surface HEPA filter, multidyhedral type, tested with D.O.P. fumes; efficiency over 99.99% for particles of 0.3 micrometre...

  • Page 35: Transport, Packing And Storage Instructions

    D:GROUP Company 11 TRANSPORT, PACKING and STORAGE INSTRUCTIONS IMPORTANT: Disconnect the power and sterilize the unit before performing any of the following operations The following instructions are essential if the end user needs to transport, pack or store a cabinet after a period of routine use (e.g.

  • Page 36: Additional Information

    D:GROUP Company 12 ADDITIONAL INFORMATION 12.A GUARANTEE The guarantee for vertical laminar air-flow cabinets is 24 months from date of invoice. In addition to those cases specifically indicated in Chapter 5 relating to improper use of the cabinet, the guarantee offered by Faster S.r.l., also excludes certain improper uses described in the instruction manual, of...

  • Page 37: Diagrams

    D:GROUP Company 13 DIAGRAMS LEGENDA RIF. DESCRIZIONE External body Screws fixing the exhaust duct Exhaust duct Cover panel Frame Screws fixing the internal panel Stirrup of frame opening Internal panel LAF plenum tie-rod LAF plenum main HEPA filter EXHAUST plenum tie-rod...

  • Page 38: Adiagram For Maintenance Operations

    D:GROUP Company 13.A DIAGRAM FOR MAINTENANCE OPERATIONS Frontal view 00055EN Rev.10 – 12/2011...
  • Page 39 D:GROUP Company Side view 00055EN Rev.10 – 12/2011...

  • Page 40: Bcyto Fast Top Frontal And Side Diagram

    D:GROUP Company 13.B CytoFAST Top FRONTAL and SIDE DIAGRAM Frontal diagram 00055EN Rev.10 – 12/2011...
  • Page 41 D:GROUP Company Side diagram 00055EN Rev.10 – 12/2011...

  • Page 42: Csafe Working Area Diagram

    D:GROUP Company 13.C SAFE WORKING AREA DIAGRAM 00055EN Rev.10 – 12/2011...

  • Page 43: Sensors List

    D:GROUP Company 14 SENSORS LIST SOFTWARE NAME PCB PLUG OF THE SENSOR DESCRIPTION not used not used Window in working position Closure panel 1 Closure panel 2 not used not used not used 00055EN Rev.10 – 12/2011...

  • Page 44: Wiring Diagram

    D:GROUP Company 15 WIRING DIAGRAM 00055EN Rev.10 – 12/2011...
  • Page 45 D:GROUP Company 00055EN Rev.10 – 12/2011...
  • Page 46 D:GROUP Company 00055EN Rev.10 – 12/2011...

  • Page 47: Procedure For Cytofast Top Assembly

    D:GROUP Company 16 PROCEDURE FOR CytoFAST Top ASSEMBLY Would the cabinet be delivered disassembled, follow the procedure shown below to assemble it: Unpack all parts of the cabinet following the instructions at page 2 point 2A. of the manual Assemble the base joining the two parts “2!”...

  • Page 48: Declaration Of Conformity

    D:GROUP Company 17 DECLARATION OF CONFORMITY The undersigned legal representative of the company Faster S.r.l. hereby declares that the follow products: CytoFAST Top are in compliance with the following directives: 2006/42/EC Directive of the European Parliament and of the Council on machinery...

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