Media Preparator STERAGAR 10 - Code n STERAGAR 16 - Code n INSTRUCTION MANUAL

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1 Media Preparator STERAGAR 10 - Code n STERAGAR 16 - Code n INSTRUCTION MANUAL International PBI S.p.A. Via Novara, Milano Italy Tel Fax info@internationalpbi.it Rev.1 Pag. 1

2 INSTRUCTION MANUAL READ CAREFULLY THIS HANDBOOK Using this manual will help you in keeping your instrument efficient. For any needs this manual should be kept in a place nearby the instrument. SAFETY INSTRUCTIONS Use the device just for the indicated purposes. The Device must be correctly installed according to these instructions, before starting any operation. Never disconnect the device by pulling electrical cable from the socket;. Replace immediately electrical cable when damaged ; never use a damaged or worn electrical cable. While removing the item connected to the electrical system pay attention to the electrical connection cable Always disconnect from electrical system when: A. Repairing or maintenance; these operations must be carried out by qualified staff only; B. Cleaning the unit; Use original spare parts and accessories for any replacement; Do not use this device in the presence of explosive gases. INSTALLATION GENERAL CAUTION CAUTION! When the electrical system socket is not compatible with device socket, replace it paying attention to codified cable colours. Brow: live Blue: neutral Yellow/green: earth Be aware that the voltage and frequency of the electrical system are compatible with device. CAUTION! The device must be connected to a ground wire. For any question please contact an electrician. Before starting-up the device be sure that ventilation grids are totally free to operate and not covered by any barriers. CAUTION! Rev.1 Pag. 2

3 SUMMARY Main index 1. INSTRUMENT DESCRIPTION INSTALLATION EXTERNAL COMPONENTS DESCRIPTION CONTROL PANEL DESCRIPTION OPERATIONS Optional Air filter STERILIZATION PARAMETERS SETTING Program P5 (Chocolate-cycle) CONFIGURATION PARAMETERS SETTINGS Sub-menu Printer Sub-menu Delay Sub-menu Print last cycle Sub-menu Password Sub-menu Date and time Sub-menu LCD contrast Sub-menu Service STERILIZATION CYCLE Program 5 (Chocolate-cycle) VALIDATION MAINTENANCE AND CLEANING TEMPERATURE/PRESSURE CHART EMERGENCY AND TROUBLESHOOTING ELECTRICAL SPARE PARTS PRINTER How to insert a new paper roll...16 WARRANTY...18 DECLARATION OF CONFORMITY...19 Rev.1 Pag. 3

4 1. INSTRUMENT DESCRIPTION 1.1 General description The Steragar is a purpose built machine for preparing, sterilising and dispensing media under controlled conditions of time and temperature. Volume of 3 to 10 liters (Steragar 10L) and 5 to 16 liters (Steragar 16L) can be prepared, sterilised and cooled to a dispensing temperature in about 1 hour depending on the sterilisation temperature, time and media volume. The sterilisation temperature, sterilisation time, dispensing temperature are set at the beginning of the cycle and they are stored in the memory even after the instrument is switched off. At the beginning of each cycle a pressure switch checks if the water input is enough to operate the unit. A constant speed mixer operates throughout the cycle to maintain even temperature and media distribution such as blood or antibiotics which can be added after sterilisation. Both the water jacket and media vessel are fitted with an automatic air vent valve which is closed when steam is passing through them and they open during the cooling step. Pressure safety valves are fitted to both vessels to protect the unit from excess pressure; pressure gauges are also fitted on each vessels to provide a visible pressure indication. To dispense the media from the container, a stainless steel connector with silicone tubing must be fitted to the media removal port. Media can then be pumped out of the vessel with a peristaltic pump or plate pouring unit. On the front control panel the media temperature is displayed continuously. The programmer has an automatic over temperature controller that disconnects the heater power supply if the temperature exceeds the set temperature. A printer is fitted on the front panel. 1.2 Safety devices Two pressure gauges allow the pressure check while two pressure safety valve ensure a safety operation. The heating process is interrupted if the temperature exceeds the set temperature or if the thermoprobe is faulty. The instrument complies to the European standard EN Technical Specifications Overall Dimensions Height Width Depth Weight Total weight including water 700 mm 650 mm 600 mm 40 Kg 50 Kg Vessel Total volume 11 lt (17lt 16L model) Usable volume 3-10 lt (5-16lts 16L model) Mixer speed 100 revolutions per minute Rev.1 Pag. 4

5 1.3.4 Parameter range Sterilisation temperature ambient to 125 C Sterilisation time 1-99 min Dispensing temperature C 1.4. Services Power Supply 220/240 V ± 5%, 50Hz 2500 W single phase. The instrument needs the following services: an efficient grounding a circuit breaker with a breaking current of 16 A and a residual current device of 30 ma a suitable power plug a water supply a drain Rev.1 Pag. 5

6 2. INSTALLATION 2.1 Preliminary inspection The instrument is subjected to specific working tests before shipment and it is carefully packed to avoid possible damage during transit. However before operation a visible check should be carried out to ascertain any transit damage which must be reported immediately. 2.2 Essential accessories list (NOT INCLUDED) Stainless steel connector "ASPIR" to remove media through the cover Flexible tube 15 mm internal diameter for inlet water connection Steam proof tube for drain connection. 2.3 Preparation for use The machine must be placed on a flat surface of sufficient strength to support the total weight of the instrument and the outlet water port should be higher than the drain. Connect water inlet to a tap 3/4 Gas (fig.2 pos 3) Connect the outlet to a drain 1-1/4 (fig. 2 pos 2). Connect the air vent valve to a drain container (fig. 3 pos. 1). From this valve a small amount of steam will escape during the heating process. Connect the electrical power supply Rev.1 Pag. 6

1) 1 2 3 6 4 5 Pos 1 Pos 2 Pos 3 Pos 4 Pos 5 Pos 6 Thermoprobe cable Water outlet Inlet water Levelling feet Electrical cable Fuses 3.

7 3. EXTERNAL COMPONENTS DESCRIPTION This chapter describes in details all the controls that can be used to control the instrument. 3.1 REAR PANEL DESCRIPTION (FIG. 1) Pos 1 Pos 2 Pos 3 Pos 4 Pos 5 Pos 6 Thermoprobe cable Water outlet Inlet water Levelling feet Electrical cable Fuses 3.3 COVER DESCRIPTION (FIG. 2) Pos 1 Automatic air vent valve Pos 2 Media removal port Pos 3 Inner vessel pressure gauge Pos 4 Additives port Pos 5 Inner vessel safety valve Pos 6 Outer vessel safety valve Pos 7 Thermoprobe Pos 8 Handwheel Rev.1 Pag. 7

8 4. CONTROL PANEL DESCRIPTION The media preparator is equipped with special designed microprocessor that control all the instrument and the sterilization cycle START STOP MENU PRINTER ON END CYCLE ALARM Pos. 1 (Display) Pos. 2 (START button) Pos. 3 (STOP button) Pos. 4 (MENU button) Pos. 5 ( button) Pos. 6 ( button) Pos. 7 (ENTER button) Pos. 8 (Led) Multi-purpose, it shows all the system messages and all the sterilization cycle parameters such as temperature and time Starts the sterilization cycle shown on the display Stops the sterilization cycle and resets all the alarms Enters the instrument setting menu Scrolls up or increases the displayed value Scrolls down or decreases the displayed value Confirms and stores the displayed value Report the status of the autoclave PRINTER ON lit when the printer is enabled END CYCLE lit at the end of a sterilization cycle ALARM lit when an alarm occurs Rev.1 Pag. 8

9 5. OPERATIONS 1. The media preparator should be placed in a room accessible by operator only. 2. Check if the hydraulic and electric connection has been made according to the previous chapter. 3. Insert the basket with the media to be prepared. 4. Close the cover by using the handles. 5. Open the inlet water tap 6. Turn on the media preparator by the main switch. 7. The instrument will start loading water in the vessel for 5 minutes W A T E R L O A D I N G 5 : When the water loading process is completes, the display will show the main menu: P T EMP 121C 60C 1 T IME 10m o P T EMP 121C 60C 2 T IME 15m... o P C m 10 5 o VESSEL T EMPERAT 21.1C o ST ERAGAR /03/ :20 9. Select the desired sterilization cycle. If you want to modify the sterilization parameter please follow the procedure described in the next chapters. 10. Press START to start the cycle. You can stop the sterilization cycle at any time by pressing the STOP button 5.1 Optional Air filter In order to reduce the possible contamination, it is possible to connect an air filter (not included) to the automatic air vent valve. This filter must be connected AFTER the sterilization step. Rev.1 Pag. 9

10 6. STERILIZATION PARAMETERS SETTING 1. Turn on the SterAgar by the main switch 2. After initial presentation and water loading process, the display will show the Program 1 (P1) P T E M P C 6 0 C 1 T I M E 1 0 m 3. To modify this program press the ENTER button, or press the or buttons until the program to be modified is displayed and then press ENTER button. P T E M P C 6 0 C 1 T I M E 1 0 m 4. An arrow will be displayed next to the sterilization temperature, press the or until the desired sterilization temperature is displayed and then press ENTER. P T E M P C 6 0 C 1 T I M E 1 0 m 5. An arrow will be displayed next to the sterilization time, press the or until the desired sterilization temperature is displayed and then press ENTER. P T E M P C 6 0 C 1 T I M E 1 0 m 6. An arrow will be displayed next to the dispensing temperature, press the or until the desired sterilization temperature is displayed and then press ENTER. 7. The modified data are automatically stored in the memory. 8. Press the START button to start the sterilization cycle. 6.1 Program P5 (Chocolate-cycle) The Program 5 can be used to run a double-cycle. It is possible to select two different temperatures and times. The media preparator will perform the sterilization and then will reach a desired value. This temperature will be kept constant and it will be possible to introduce some additives inside the vessel through the addition port. After the addition the START button must be pressed to start the second part of this cycle NOTE: The set values are stored in the memory and will not be lost after switching off the instrument. Rev.1 Pag. 10

11 7. CONFIGURATION PARAMETERS SETTINGS Press the MENU button to modify the instrument configuration parameters settings. There are seven sub-menus: PRINTER modifies the printer settings DELAY sets a delayed start of the sterilization cycle PRINT LAST CYCLE prints the last sterilization cycle completed PASSWORD set a password to prevent unauthorized modification of the sterilization and instrument settings DATE AND TIME modify the autoclave date and time LCD CONTRAST modifies the adjustment of the display contrast SERVICE This menu is for maintenance authorized personnel only. The parameters stored in this menu can only be displayed but not modified. 7.1 Sub-menu Printer P R I N T E R from this menu it is possible to enable or disable the printer, to set two different printing interval for the sterilization phase and the heating/cooling phase. Press ENTER button from the PRINTER menu; the working flow is the following: PRINT ER ON PRINT ER ACT IVAT ION o PRINT ING INT ERVAL o PRINT ER OFF ST ERILIZ. PHASE 1min ENTER ENTER to confirm MENU to exit o to increase or decrease MENU to exit HEAT /COOL PHASE 1 min o to increase or decrease MENU to exit If the printer is enabled the PRINTER ON led on the control panel will be lit. The printing intervals can be set from a minimum of 1 minute up to a maximum of 30 minutes with a 1 minute step. Rev.1 Pag. 11

12 7.2 Sub-menu Delay D E L A Y 0 0 : 0 0 From this menu it is possible to set a delayed start of the sterilization cycle. From the DELAY screen press the ENTER button: DELAY 00:00 o to increase or decrease MENU to exit ENTER DELAY 00:00 o to increase or decrease MENU to exit Once the delay has been set, after pressing the START button the display will show the delay and the remaining time to the cycle beginning. The delay is stored in the memory, set 00:00 as delay to reset the delay. The maximum settable delay is 23: Sub-menu Print last cycle P R I N T L A S T C Y C L E from this menu it is possible to print the last completed cycle by pressing the ENTER button. 7.4 Sub-menu Password P A S S W O R D From this menu it is possible to set a password to prevent unauthorized modification of the sterilization and instrument settings. The password can be set by pressing the ENTER button from the PASSWORD OLD PASSWORD 0*** o to increase or decrease MENU to exit ENTER to skip to next digit NEW PASSWORD 0*** o to increase or decrease MENU to exit ENTER to skip to next digit Rev.1 Pag. 12

13 From the main menu the password will be requested every times the ENTER or MENU buttons are pressed. A password will not be requested if the password value has been set to 0000 (default value). 7.5 Sub-menu Date and time D A T E A N D T I M E From this menu it is possible to adjust the date and time. Press ENTER button from the DATE AND TIME menu 02/03/ :00 o to increase or decrease ENTER to skip to the next field MENU to exit 7.6 Sub-menu LCD contrast L C D C O N T R A S T 5 5 [ % ] From this menu it is possible to adjust the display contrast. Press ENTER button from the menu LCD CONTRAST LCD CONT RAST 55 [%] The contrast default value is set to 55% o to increase or decrease MENU to exit 7.7 Sub-menu Service S E R V I C E This menu is for maintenance authorized personnel only. The parameters stored in this menu can only be displayed but not modified. Rev.1 Pag. 13

14 8. STERILIZATION CYCLE 1. Select the desired sterilization program; 2. Press the START button 3. The display will show on the upper raw the selected cycle (temperature and time), and the step in progress; while on the lower raw will show the actual vessel temperature and the remaining sterilization time. P S T E P C m C m 4. Once the sterilization temperature has been reached, the sterilization time count will begin. At the end of the sterilization time a buzzer is activated: 5. After the cooling process, when the vessel temperatures reaches the dispensing temperature, the display will also show DISPENSING and the product is ready to be dispensed 6. Once the dispensing process is completed, press STOP button and open the lid with the handle. 7. Switch off the autoclave with the main switch 8.1 Program 5 (Chocolate-cycle) The Program 5 can be used to run a double-cycle. It is possible to select two different temperatures and times. The media preparator will perform the sterilization and then will reach a desired value. This temperature will be kept constant and it will be possible to introduce some additives (blood or antibiotics) inside the vessel through the addition port. After the addition the START button must be pressed to start the second part of this cycle 9. VALIDATION It is possible to validate the instrument with an external certified thermoprobe. Insert the certified thermoprobe in the vessel through the addition port and run a cycle. If a temperature correction is needed please call a qualified technician. For more details contact your local distributor. 10. MAINTENANCE AND CLEANING The media preparator should be annually inspected according to the Good laboratory practice. A daily cleaning of the instrument will prevent most of future faults and contaminations. It is possible to clean the vessels with a mild detergent an a wet soft cloth. To avoid contamination keep the automatic air vent valve clean. WARNING Do not use any cleaning product containing halogens or other aggressive substance to clean the autoclave. Usage of this product can cause rust. The gaskets must be kept clean and greased with silicon-based oil Rev.1 Pag. 14

15 11. TEMPERATURE/PRESSURE CHART Temperature ( C) Pressure (bar) 0 0,1 0,2 0,4 0,5 0,7 0,9 1,0 1,5 2,0 12. EMERGENCY AND TROUBLESHOOTING A malfunction or an alarm condition can happen during the normal working procedure. In the following table the most common faulty conditions are described as well as their possible corrective actions. BEFORE OPENING THE DOOR, PLEASE CHECK ON THE PRESSURE GAUGE THAT THERE IS NO PRESSURE INSIDE THE VESSEL. EFFECT CAUSE ACTION Main switch and display are off Display is off and the main switch led is on Heating element is not working The instrument is not reaching the programmed temperature. The autoclave is reaching normally 100/110 C, but not over this temperature The vessel temperature is more than 125 C ALARM led is lit and the display shows: LOW WATER PRESSURE ALARM led is lit and the display shows: ALARM OVERTEMPERATURE No electrical power No power to the main board Faulty heating element - Vent valve clogged - Faulty electrovalve Faulty electrovalve Faulty solid state relay - Inlet water not open - faulty pressure switch Vessel overheating - Check mains voltage - Check power connections - Check fuses Contact the technical service, possible faulty main board or low-voltage power supply Contact the technical service Clean thoroughfully; if the problem persist contact the technical service Contact the technical service Contact the technical service Open the inlet water tap, check the hydraulic connections; if the problem persist contact the technical service Contact the technical service Rev.1 Pag. 15

13. ELECTRICAL SPARE PARTS Pos. 1 67089 Line fuses Pos. 9 78383 Printer (optional) Pos. 2 67101 Main switch Pos. 10 66034 Safety thermostat Pos. 3 78401 Noise filter Pos.

16 13. ELECTRICAL SPARE PARTS Pos Line fuses Pos Printer (optional) Pos Main switch Pos Safety thermostat Pos Noise filter Pos Solid state relay Pos V Power supply Pos Heating element Pos Thermoprobe Pos Safety relay Pos Electronic Board Pos Solenoid switch Pos Lid microswitch Pos Solenoid Pos Electrovalve 14. PRINTER The Steragar is equipped with a thermal printer. The stored informations are the following: a) Instrument model and serial number b) Date and time of the cycle beginning of the sterilization c) Cycle parameters set (temperatures and time) c) Vessel temperatures recorded with the set interval time Furthermore it possible to write down the batch number and operator sign Pos.1 Pos.2 Pos.3 Pos.4 Pos.5 Opening button Paper roll container Printing head Status led Paper feed button How to insert a new paper roll To open the printer press the central green button Rev.1 Pag. 16

17 Place a new paper roll according to the procedure described in the following pictures If the paper has been correctly placed, the led in the central green button will remain steady. A flashing led means an error in the paper feeding. See paragraph 8.1 of this manual for the directions to modify the printing interval. Rev.1 Pag. 17

18 WARRANTY WARRANTY CONDITIONS International PBI warrants this product to be free of defects in materials and functionality The repairs will be effected by International PBI or by authorized dealers as follows: - Faulty components free replacement The labour is always at customer's expense - The equipment will be sent at buyer's expenses and risk and the return will be ex-works - This warranty does not apply to damages resulting from tampering, abnormal use and installation and does not cover transport damages - International PBI shall not be liable for any commercial damages, whether incidental, consequential or otherwise derived from the use of instruments ATTENTION, READ CAREFULLY TO OUR NEW CUSTOMER As a user of our equipment you are covered for a 12 months guarantee for all spare parts as a result of mechanical failure of the machine during normal use. In order to provide you with first class service, it is essential for us to know all your references and which equipment you have. We kindly ask you therefore to fill in the attached guarantee and return the card to us by first class mail. FUR UNSERE NEUEN KUNDEN Für Benutzer unserer Apparate sind alle Ersatzteilen die sich aus mechanischen Fehlern in normalen Gebrauch ergeben., für zwölf Monate garantiert. Damit wir Ihnen einem erstklassigen Service dienen können, ist es unbedingnotwending, dass wir wissen wo Sie sind und welches Gerat Sie haben. Darum bitten wir Sie, die beiliegende Garantiekarte auszufüllen, und Sie uns per Post zuzuschicken. PBI bietet Ihnen auch einen vorbeugenden Kundendienst, um dafür zu sorgen, dass Ihre Apparate zu allen Zeiten in Ordun sind, dass Sie regelmäßig kontrolliert werden, einen Express Krisen-Service, wenn ein Apparat ausfallt. Ihr Verkaufs Agent hat alle Details des Service Kontraktes und kann Ihnen Preise offerieren. A TODOS NUESTROS NUEVOS CLIENTES El equipo adquirido por Vd. Está garantizado por doce meses contra cualquier defecto de fabricación que pudiera producir avería durante el uso normal. Con el fin de poderle ofrecer un servicio eficiente, es esencial que sepamos su nombre o razón social, dirección y equipo adquirido. Para ello, rogamos que por favor rellene el certificado de garantía adjunto y nos lo envíe por correro certificado. PBI también puede ofrecer un servicio postventa de mantenimiento preventivo para mantener el perfecto estado de funcionamento de su equipo, asì como ofrecerle una atencion normal y un rapido servicio en el caso de que su equipo falle. Rev.1 Pag. 18

19 DECLARATION OF CONFORMITY International pbi S.p.A. Via Novara, Milano HEREBY DECLARES under its sole responsibility that the following product Automatic Media Preparator Steragar 10 cod Automatic Media Preparator Steragar 16 cod the following harmonized standard applies EN , EN , EN EC Directive 2002/95/EC of the European Parliament: Restriction of the use of certain hazardous substances (RoHS) for electric and electronic devices The EC RoHS Directive has been released for the restriction of the use of certain hazardous substances in electric and electronic devices and basically says that with July 1 st 2006 new productions of electric and electronic devices may not contain lead, mercury, cadmium, hexavalent chromium, polypromined biphenyl (PBB), respectively polybromined diphenylether (PBDE). As a consequence of this EC Directive we have to introduce unleaded technology in our production and we have to make adaptations concerning the use of lead, mercury, cadmium, hexavalent chromium, PBB, PBDE according to the defined permissible values. The adaptation of our products to the RoHS conformity is confirmed. EC Directive 2002/96/EC of the European Parliament: Disposal of old products Our products are designed and manufactured with high quality materials and components which can be recycled and reused according to the EC Directive 2002/96/EC. The user should inform himself about the separate collection system for electrical and electronic products. He should act according to the local rules and do not dispose of the old products with the normal household waste. The correct disposal of old products will help to prevent potential negative consequences for the environment and human health. conforms with the technical requirements of the following directives 2006/95/CEE, 2004/108/CEE, 97/23/CEE Milan, 2010 Roberto Ligugnana The President Rev.1 Pag. 19

Steam Sterilizer AUTO KOCH - Code n

Steam Sterilizer AUTO KOCH - Code n. 39159 INSTRUCTIONS MANUAL International PBI S.p.A. Via Novara, 89 20153 Milano Italy Tel + 39 02 48779-1 Fax + 39 02 40090010 E-mail: info@internationalpbi.it www.internationalpbi.it