EMBEDDING STATION CD1000/L
Contents
1. Q 2 gt eb OC ISO 9001 i Bio Optica Milano S p A e via San Faustino 58 e I 20134 Milano Fap LO a p I CA Tel 39 02 21 27 13 1 e Fax Acquisti Export 39 02 21 54 155 eww Bic oplica i Fax Assistenza Contabilit 39 02 26 41 74 48 e Fax Vendite 39 02 21 53 000 User manual CentralinaCD1000 L Milano 14 luglio 2011 DICHIARAZIONE DI CONFORMITA DECLARATION OF CONFORMITY KONFORMITATSERKLARUNG DECLARATION DE CONFORMITE Nome e indirizzo della ditta BIO OPTICA Milano S p A Name and address of the firm Via S Faustino 58 Name und Adresse der Firma 20134 MILANO Nom et adresse de l enterprise C F P IVA 06754140157 Dichiariamo sotto la nostra responsabilit che We declare under our sole responsibility that Wir erkl ren in alleiniger Verantwortung dass Nous declarons sous notre propre responsabilit que il dispositivo medico diagnostico in vitro the in vitro diagnostic medical device das Medizinprodukt f r die In vitro_Diagnostik le dispositif medical de diagnostic in vitro 23 CD1000 L della classe Altro of class Other der Klasse Sonstiges produrti de la classe Autre soddisfa tutte le disposizioni della direttiva 98 79 CE che lo riguardano meets all the provisions of the directive 98 79 EC which apply to it allen Anforderungen der Richtlinie 98 79 EG entspricht die anwendbar sind remplit toutes les exigences de la directive 98 79 CE qui le concernent EN 375 22. Cold point for rapid cooling 55 mm spot cooled at ca 3 through Peltier pl ate with independent ignition Revision 110714 of 14 07 11 csQ Page 9 of 20 MED ISO 9001 ISO 13485 Sl _ Bio Optica Milano S p A e via San Faustino 58 e I 20134 Milano j L O we VI LCA Tel 39 02 21 27 13 1 e Fax Acquisti Export 39 02 21 54 155 www bio optica it Fax Assistenza Contabilita 39 02 26 41 74 48 e Fax Vendite 39 02 21 53 000 User manual CentralinaCD1000 L Instructions for use of 23 DP500 1 Press the green general switch to start the instrument and the paraffin basin resistance 2 Regulate the temperature following the instructions shown on the following pages Remember that T1 corresponds to the paraffin basin temperature T2 to the working plate temperature 3 In order to switch on the halogen lamp rotate the ring placed on the lamp body clockwise Photo on the left 4 In order to obtain the rapid cooling of the samples switch on the cooling plate Peltier by pressing the orange switch 5 In order to obtain the paraffin supply draw up a finger or a metal object to the grey proximity sensor placed under the nozzle Photo on the right or press the pedal optional accessory Regulate the paraffin flow with the white knob placed over the nozzle Important After the instrument ignition at least 2 hours are necessary to obtain the complete heating of the dispenser and the consequent supply of melted
3. the paraffin collecting drawer placed on the frontal side must to be emptied daily For Freezer Plate effect the periodic cleaning of the back grids The instrument does not need to be sterilized because is not expected the treatment of fresh samples but only of histological samples fixed and included in paraffin Maintenance Effect the periodic cleaning Revision 110714 of 14 07 11 CSQ Page 7 of 20 MED ISO 9001 ISO 13495 ID l Bio Optica Milano S p A e via San Faustino 58 e I 20134 Milano LO wr N p rca Tel 39 02 21 27 13 1 e Fax Acquisti Export 39 02 21 54 155 www bio optica i Fax Assistenza Contabilit 39 02 26 41 74 48 e Fax Vendite 39 02 21 53 000 User manual CentralinaCD1000 L Replacing the fuses If the instrument doesn t start check that the electric cable has been connected properly there is current and the two fuses under the instrument s socket aren t burnt If necessary change them with fuses of identic value SOCKET INPUT Fuses holder socket N 2 delayed fuses Instructions for the replacement Switch off the appliance and unplug the cable from the socket Make a light pressure on the little carter covering the fuses if necessary using a little screwdriver change them close the carter and check the instrument s ignition CEA Mii Revision 110714 of 14 07 11 CSQ Page 8 of 20 MED ISO 9004 ISO 13485 fido Bio Optica Milano S p A e via San Faustino 58 e
4. Milano S p A e via San Faustino 58 e I 20134 Milano L O sr I CA Tel 39 02 21 27 13 1 e Fax Acquisti Export 39 02 21 54 155 www bio optica t l Fax Assistenza Contabilit 39 02 26 41 74 48 e Fax Vendite 39 02 21 53 000 User manual CentralinaCD1000 L 2 Thermal Unit 23 UT200L Thermal unit used for paraffin and blocks heating Dimensions WxDxH 360x550x290 mm Blocks upper chamber dimensions WxDxH 315x210x104 mm Removable upper basin WxDxH 310x195x100 mm Capacity ca 5 5 litres Samples lower basin dimensions WxDxH 265x205x40 mm Capacity ca 3 litres Weight 17 kg Power 330 Watt Fuses N 2 fuses of 3 15 Ampere 5x20 mm T3 15AH250V Working temperature Adjustable from 20 to 70 Reading precision 2 Structural features of 23 UT200L Painted sheet steel chassis Structure consisting of two stainless steel working areas heated and thermostated separately Fixed upper chamber with cover used for the inclusion blocks preheating Removable upper basin that can be used to contain the cassette holder baskets coming directly from the processor with maximum height of 100 mm Removable lower basin with horizontal sliding cover used to melt scale paraffin where processed samples are placed before being included Revision 110714 of 14 07 11 CSQ Page 14 of 20 MED ISO 9001 ISO 13485 2 49 Bio Optica Milano S p A e via San Faustino 58 e I 20134 Milano L O er p I CA T
5. panel 37 4041 37 4043N 37 4050F 37 4225 37 6012 37 6013 37 6014 37 7001 37 24548B2BY female connector dispenser sensor mica resistance waste drawer resistance cartridge resistance r g a bipolar switch Revision 110714 of 14 07 11 cso Page 11 of 20 MED ISO 9001 ISO 13485 fr Pi i2 Bio Optica Milano S p A e via San Faustino 58 e I 20134 Milano L O a p I CA Tel 39 02 21 27 13 1 e Fax Acquisti Export 39 02 21 54 155 avvi Bio optica it Fax Assistenza Contabilit 39 02 26 41 74 48 e Fax Vendite 39 02 21 53 000 User manual CentralinaCD1000 L o aoa dipperchasis T_1_ 3710982 hinged cover 1 O 39 109858 SSCs base a 37109874 eraino 1 ee oe Revision 110714 of 14 07 11 Page 12 of 20 MED ISO 9001 ISO 13495 _ Bio Optica Milano S p A e via San Faustino 58 e I 20134 Milano 1 L O er I CA Tel 39 02 21 27 13 1 e Fax Acquisti Export 39 02 21 54 155 www Bic optica it Fax Assistenza Contabilit 39 02 26 41 74 48 e Fax Vendite 39 02 21 53 000 User manual CentralinaCD1000 L Electric wiring diagram 23 DP500 YI9 dE FAME a FIDATO 4 I g IPL TUL EIM fe SONG LES MEA JHH GOR WILE piaga na LITRI OLS HOSSH 1E o o s o e s s s s e s Jin Jura ALA 4 Der CONILONPSHL Pe TIERCE EAA Ibe he Revision 110714 of 14 07 11 cso Page 13 of 20 MED ISO 9001 ISO 13485 ope Bio Optica
6. use any extension or adapter and do not modify the provided cable Revision 110714 of 14 07 11 C SQ Page 4 of 20 MED ISO 9001 ISO 13495 eO Bio Optica Milano S p A e via San Faustino 58 e I 20134 Milano I O se N LCA Tel 39 02 21 27 13 1 Fax Acquisti Export 39 02 21 54 155 www bio optica it Fax Assistenza Contabilit 39 02 26 41 74 48 e Fax Vendite 39 02 21 53 000 User manual CentralinaCD1000 L Backlit control panel The working of the control panel is equal for all the three modules The only difference regards T1 and T2 probes In the Freezer Plate there is only T1 probe which measures the temperature of the stainless steel plate In the Paraffin Dispenser T1 probe measures the temperature of the paraffin basin T2 probe the temperature of the working plate In the Thermal Unit T1 probe measures the temperature of the upper chamber T2 probe the temperature of the lower basin TIMER DELAY Delay the automatic instrument s turn off TEMPERATURE SETTING Set the desired temperature value MENU Allows to access the functions ENTER Accept store values O O UP DOWN SELECTIONS BUTTONS Modify values or select the functions Display Automatic switching off Timer 08 35 56 Temperature measured from T1 probe Temperature measured from T2 probe CEA Revision 110714 of 14 07 11 csQ Page 5 of 20 MED ISO 9001 ISO 13485 YI E i Bio Optica Milan
7. 001 EN 980 2003 EN ISO 14971 2007 EN 60601 1 2 2007 EN 61010 1 2001 03 EN 61010 2 101 2002 EN 61010 2 010 2003 10 Norme nazionali o armonizzate applicate Applied harmonised standards and National standards Angewandte harmonisierte Normen nationale Normen Normes harmonis es et normes nationales BIO OPTICA MILANO SPA Legale Rappresentante Carlo Sbona Revision 110714 of 14 07 11 cso Page 20 of 20 D ISO 9001 ISO 13485
8. I 20134 Milano T t O Lr p I CA Tel 39 02 21 27 13 1 e Fax Acquisti Export 39 02 21 54 155 wenn bio optica it Fax Assistenza Contabilit 39 02 26 41 74 48 e Fax Vendite 39 02 21 53 000 User manual CentralinaCD1000 L FEATURES OF THE SEPARATE MODULES 1 Paraffin Dispenser 23 DP500 Paraffin dispenser used to effect the inclusion of histological samples quickly and cleanly The constant temperature of the paraffin basin of the working plate and the separate heating of the dispensing nozzle assure the optimal working temperature Dimensions WxDxH 360x550x290 mm Paraffin basin dimensions WxDxH 300x150x100 mm Capacity ca 4 litres Working plate dimensions WxD 360x300 mm Weight 21 kg Power 700 Watt Fuses N 2 fuses of 4 Ampere 5x20 mm T4AH250V Working temperature Adjustable from 20 to 70 Reading precision 2 Structural features of 23 DP500 Painted sheet steel chassis Structure consisting of two working areas heated and thermostated separately Stainless steel paraffin basin with cover used to melt scale paraffin Aluminium working plate provided with 6 heated seats for tweezers and paraffin collecting drawer both heated Paraffin dispensing system through dispensing nozzle controlled by proximity sensor free of maintenance or through pedal optional accessory Flow adjustment through regulation knob Lighting through articulated halogen lamp of 12 Volt 5 Watt
9. edure After pressing this screen will appear Press O O to modify the switching off of the resistance At last press for 3 seconds to exit The main screen will appear on the display Revision 110714 of 14 07 11 csQ Page 6 of 20 MED F mn ISO 9001 ISO 13485 i2 4 Bio Optica Milano S p A e via San Faustino 58 e I 20134 Milano L O a p I CA Tel 39 02 21 27 13 1 e Fax Acquisti Export 39 02 21 54 155 www Bio optica it Fax Assistenza Contabilit 39 02 26 41 74 48 e Fax Vendite 39 02 21 53 000 User manual CentralinaCD1000 L Timer delay To delay the automatic switching off of the instrument press for 4 seconds When the switching off time will flash it will be possible to modify it by pressing 08 35 56 This operation does not modify the preset switching off time Timer esclusion manual operating To operate the instrument manually it is necessary to set all days to ON see Setting the timer On the display will appear ON To start or switching off the instrument it will be necessary to use the general switch every time Cleaning Before effecting the cleaning switch off the instrument and unplug the cable from the socket Use only alcohol or non aggressive detergents Do not use abrasive products or acids in order to avoid ruining the varnished or plastic parts A plastic spatula can be used to remove residual paraffin For Paraffin Dispenser
10. el 39 02 21 27 13 1 e Fax Acquisti Export 39 02 21 54 155 j eww io optica i Fax Assistenza Contabilit 39 02 26 41 74 48 e Fax Vendite 39 02 21 53 000 User manual CentralinaCD1000 L Instructions for use of 23 UT200L 1 Press the green general switch to start the instrument and the lower basin resistance 2 Regulate the temperature following the instructions shown on the following pages Remember that T1 corresponds to the upper chamber temperature T2 to the lower basin temperature Main components of 23 UT200L 6 ampere wire filter 2 temperatures thermal timer green waterproof switch polycarbonate panel arenes removable lower dish _ 77 Revision 110714 of 14 07 11 l c5Q Page 15 of 20 MED ISO 9001 ISO 13485 Bio Optica Milano S p A e via San Faustino 58 e I 20134 Milano I CA Tel 39 02 21 27 13 1 e Fax Acquisti Export 39 02 21 54 155 Fax Assistenza Contabilit 39 02 26 41 74 48 e Fax Vendite 39 02 21 53 000 User manual CentralinaCD1000 L 10 Wan DiG Opi Ial Electric wiring diagram 23 UT200L POT E 2 SJSN aca lca Cadre 2 AS INILOMAIHL NosTI6E dE JF pi ae m tet A hu Bi Ma a RS CL ay er uranyl sy dig PSE Pog 3 LOGO CE DAL I ESCO L Lydd DILULHLE BDcSsd e Nelle HST JHIA CALI L a Jil d Aiea r 43 Revision 110714 of 14 07 11 i Page 16 of 20 MED ISO 9001 ISO 13485 ii a Bio Optica Milano S p A e via Sa
11. fi Bio Optica Milano S p A e via San Faustino 58 e I 20134 Milano i O or p LCA Tel 39 02 21 27 13 1 e Fax Acquisti Export 39 02 21 54 155 i www bio aptica Fax Assistenza Contabilita 39 02 26 41 74 48 e Fax Vendite 39 02 21 53 000 User manual CentralinaCD1000 L EMBEDDING STATION CD1000 L Code 23 CD1000 L CE IvD In the photo from the left Freezer Plate Paraffin Dispenser Thermal Unit csQ Revision 110714 of 14 07 11 Page 1 of 20 MED ISO 9001 ISO 13485 13485 i Bio Optica Milano S p A e via San Faustino 58 e I 20134 Milano Fap LO a p I CA Tel 39 02 21 27 13 1 e Fax Acquisti Export 39 02 21 54 155 nti apica Fax Assistenza Contabilit 39 02 26 41 74 48 e Fax Vendite 39 02 21 53 000 User manual CentralinaCD1000 L USE PRECAUTIONS Before using the instrument read carefully the instructions and warnings contained in this manual and keep it for further reference They supply important indications regarding the functions and safety for installing using and maintaining the instrument Bio Optica Milano S p A cannot be held responsible for any damage caused by improper or incorrect use and by the non observance of any of the prescription provided in this manual and by the safety regulations in force 1 After unpacking make sure that the instrument is complete and not damaged by transport 2 Before connecting the instrument to the power supply make sure that its rati
12. ion 110714 of 14 07 11 csQ Page 17 of 20 MED ISO 13485 i Bio Optica Milano S p A e via San Faustino 58 e I 20134 Milano Fap LO a p I CA Tel 39 02 21 27 13 1 e Fax Acquisti Export 39 02 21 54 155 eww Bio oplica it Fax Assistenza Contabilit 39 02 26 41 74 48 e Fax Vendite 39 02 21 53 000 User manual CentralinaCD1000 L Instructions for use of 23 PF200L 1 Press the green general switch to start the cooling system 2 Regulate the temperature following the instructions shown on the following pages T1 corresponds to the stainless steel plate temperature Main components of 23 PF200L Revision 110714 of 14 07 11 cso Page 18 of 20 D ISO 9001 ISO 13485 d7 B3 IH THERMOTIMER User manual CentralinaCD1000 L lLled4367 B 910 E EXCITE 1 eefe Bio Optica Milano S p A e via San Faustino 58 e I 20134 Milano Tel 39 02 21 27 13 1 e Fax Acquisti Export 39 02 21 54 155 Fax Assistenza Contabilita 39 02 26 41 74 48 e Fax Vendite 39 02 21 53 000 1 E a J 5 di T a rca PF200L Opi Ha Opi fae rn AN Bio Electric wiring diagram 23 di dea 47 G_EDTE Ni COMPRESSOR 37 RS208 I E STATIC RELAY 0 14 per E Tak BRERA o 13 ehej aee ajll E i0 ELECTRIC WALWE PP Ce k LTE ETPETTI O LE ioe Splice ELECTRIC WIFE DIAGRAM LATERAN Hee Bii MILLI ISO 13485 MED Page 19 of 20 _ N x lt f rT q O lt f y N i T
13. n Faustino 58 e I 20134 Milano I O a LCA Tel 39 02 21 27 13 1 e Fax Acquisti Export 39 02 21 54 155 sa www bio optica it i Fax Assistenza Contabilit 39 02 26 41 74 48 e Fax Vendite 39 02 21 53 000 User manual CentralinaCD1000 L 3 Freezer plate 23 PF200L Freezer plate used to obtain the rapid cooling of histological samples included in paraffin Dimensions WxDxH 500x550x290 mm Cooling chamber dimensions WxDxH 422x245x48 mm Weight 30 kg Power 600 Watt Working temperature Adjustable from 20 to 20 Reading precision 2 Structural features Painted sheet steel chassis Stainless steel cooling surface which can house up to 250 standard embedding cassettes placed in vertical position in the proper guides Number of guides that the plate can house 12 Provided with plexiglass transparent cover and 48 mm high edge where is concentrated most of the cooling power to obtain a refrigerated chamber and not only a cold supporting plane The advantages of this solution are 1 a high cooling power independently from the contact between the cassette and the supporting surface 2 absence of condensate on the supporting plane condensate limits at 0 the real temperature on the wo rking surface 3 absence of condensate drippings on the laboratory bench 4 higher number of cooled cassettes Cooling system by compressed cycle without CFC N 3 metal guides for cassettes 23 PF210L Revis
14. n compliance with EU directive 2002 96 CE regarding electric and electronic appliances waste This mean that the instrument at the end of its useful life must be collected separately from other refuse The user must deliver it to the special differentiated refuse collection centres that are predisposed by the public authority 9 The contents of this manual is subject to change without further notice 10 Please find enclosed the declaration of conformity fi om csQ Loy Revision 110714 of 14 07 11 ssa Page 2 of 20 D ISO 9001 ISO 13485 l fi Bio Optica Milano S p A e via San Faustino 58 e I 20134 Milano J L O LE p I CA Tel 39 02 21 27 13 1 e Fax Acquisti Export 39 02 21 54 155 fue io blica Fax Assistenza Contabilit 39 02 26 41 74 48 e Fax Vendite 39 02 21 53 000 User manual CentralinaCD1000 L 11 Graphic symbols indicated on the label positioned near the instrument s power supply socket Symbol for CATALOGUE NUMBER REF Symbol for SERIAL NUMBER 2 SN Symbol for ALTERNATING CURRENT Symbol for FUSE TF Symbol for CONSULT THE INSTRUCTIONS lil Symbol for EC MARK CE Symbol for IN VITRO DIAGNOSTIC MEDICAL DEVICE Symbol for DISPOSAL OF ELECTRIC AND ELECTRONIC EQUIPMENT A Symbol for DATE OF MANUFACTURE ni Symbol for MANUFACTURER Revision 110714 of 14 07 11 l csQ Page 3 of 20 MED ISO 9001 ISO 13485 bz rc Bio Optica Milano S
15. ng corresponds to that of the power supply 3 This instrument must only be used for the purpose for which it was designed that is as embedding station for laboratory use Any other use is to be considered improper and therefore hazardous 4 The instrument must only be used by authorized and professionally qualified technician 5 The electrical safety of this instrument can be guaranteed only if it is correctly connected to an efficient earth circuit as indicated by current electrical safety regulations It is necessary to check this fundamental safety prerequisite and if in doubt ask to check the circuit The instrument is provided with a power supply cable having 2 wires ground tap that have to be connected to the power supply socket 6 Do not remove the chassis or parts of it during operation Switch off the instrument and disconnect the power supply cable before opening it This operation must to be effected only by authorized and professionally qualified technician 7 To eliminate instrument malfunctioning risks do not work near strong magnetic fields and do not use transmitters such as cellular phones near the instrument In case of serious malfunctioning switch off the instrument and contact the Technical Assistance Service 8 All waste material both infectious and radioactive deriving from the appliance working cycle must be disposed in compliance with the regulation in force This appliance is marked from this symbol i
16. o S p A e via San Faustino 58 e I 20134 Milano J LO sr p ca Tel 39 02 21 27 13 1 e Fax Acquisti Export 39 02 21 54 155 www Bic optica i Fax Assistenza Contabilit 39 02 26 41 74 48 e Fax Vendite 39 02 21 53 000 User manual CentralinaCD1000 L Setting the temperature Press to display the temperature and O O to change it The value is saved automatically after 5 seconds the main screen appears on the display or by pressing O for 4 seconds Setting time and date Before setting the timer control time and date by pressing simultaneously and D The day will flash if to view the time and if necessary modify it by pressing necessary modify it pressing Press Press to exit Setting the timer The timer allows to plan the starting and switching off of the instrument for every day of the week Example From Monday to Friday starting ON at 08 00 a m switching off OFF at 18 30 p m On Saturday and on Sunday switching off Press to view this screen Progr Day Work Monday TIMER Press O O to set the starting or switching off for Monday To confirm press Repeat for every day of the week up to Sunday Afterwards will be displayed this screen pay Progr Timer Start T1 08 00 To modify the starting time press Q and to confirm Where provided a second screen will appear and it will be possible to set the starting time of the second resistance T2 Use the same proc
17. p A e via San Faustino 58 e I 20134 Milano ZII L O a p I CA Tel 39 02 21 27 13 1 e Fax Acquisti Export 39 02 21 54 155 www bia optica it Fax Assistenza Contabilit 39 02 26 41 74 48 e Fax Vendite 39 02 21 53 000 User manual CentralinaCD1000 L DESCRIPTION Modular instrument used to effect the paraffin inclusion of cytological and histological samples Composed of three separate modules called Paraffin Dispenser Thermal Unit and Freezer Plate which can be positioned in a different way depending on the operator s requirements Dimensional features Dimensions WxDxH 1200x560x290 mm Weight 68 Kg Electrical connections Power supply 230V 50 60Hz Power 1630 Watt in total Other connections Water connections Not necessary Fumes aspiration filtration Not necessary Technical features common to the three modules Working temperature adjustment Through electronic thermostat with microprocessor Working parameters visualization and modification Through control panel with digital display bilingual Italian and English Programming possibility Instrument starting and switching off weekly Installation Position the instrument on a level and stable working bench and connect it to the power supply socket 230V 50 60Hz using the provided cable For the Freezer Plate Make sure that the back grid has at least a 10 cm free space in order to allow the aeration of the cooling system Important Do not
18. paraffin Halogen lamp Dispensing nozzle controlled by proximity sensor cso Revision 110714 of 14 07 11 Page 10 of 20 MED ISO 13485 se 2 49 Bio Optica Milano S p A e via San Faustino 58 e I 20134 Milano L O er p I CA Tel 39 02 21 27 13 1 e Fax Acquisti Export 39 02 21 54 155 j anai Bio optica i Fax Assistenza Contabilit 39 02 26 41 74 48 e Fax Vendite 39 02 21 53 000 User manual CentralinaCD1000 L Main components of 23 DP500 DESCRIPTION QUANTITY 37 AR09E2F6A 37 B311 2N 37 BSP 1 37 BSP50X46 37 FI100 37 FP604 37 GH100 37 RS208 37 0041 37 129C240 37 129 432 37 181 D 37 223 8601N 37 1003 37 1023 37 1044 37 1044 1 37 1044 2 37 1044 3 37 1045 37 1046 37 1046A 37 1047 1 37 1047 2 37 1047 3 37 1050 37 1050 1 37 1050 2 37 1050 3 37 1050 4 37 4039 6 ampere wire filter N 2 temperatures thermal timer tube for block paraffin waste block paraffin tank filter noise filter paraffin tank metal ring Static relay panel socket electric valve body green waterproof switch diode transformer resistance rubber feets paraffin passage block brass nut for block brass nipple basin fixing joint power supply cable peltier cell peltier cell feeder aluminium plate plexiglas plate aluminium disc for peltier paraffin dispenser block stainless steel rubber holder delrin screw stainless steel nozzle teflon guide heat dissipator halogen lamp spare bulb code 37 370 3077 polycarbonate
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EMBEDDING STATION CD1000/L