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bio-optica – ftp300 histology vacuum tissue processor user manual

1. Nesi a I ojo MED ICA anna Io ATAR ISO 90071 150 13485 px Se e fi Bio Optica Milano S p A e via San Faustino 58 e 1 20134 Milano Tel 39 02 21 27 13 1 e Fax Acquisti Export 39 02 21 54 155 IO lt p Ica Fax Assistenza Contabilit 39 02 26 41 74 48 e Fax Vendite 39 02 21 53 000 www bio optica it In the example shown above none of the reagent requires maintenance The RMS table shows DAF Decreasing Aging Factor counter LIM predefined limits CAS counter of the actual number of cassettes processed PROC counter of the number of process performed SUBST the tank that needs to be changed The counters of the purge reagents and the charcoal filter The color of the tanks indicates the quality of the reagents as follow GREEN new reagent or already used reagent but with DAF counter not exceeding its limit RED reagent that has reached exceeded the limit GREY tank with not defined content BLACK empty tank The screen will instruct the user to renew the reagent tanks that exceed the previously set limits By pressing the DO IT WITH RFP icon the current tank substitution will be made with the Remote Fill amp Drain system CAUTION gt To avoid mistakes it is advisable to faithfully follow the given instructions and to confirm by pressing CONFIRM each singular substitution gt The reagents must be substituted ONLY if the RMS requests for tha
2. Grease the processing chamber lid gasket with silicone or PTFE grease Grease the bottle insertion o rings with silicone or PTFE grease cso cso Rev 120416 of 16 04 12 hs Page 58 of 64 MED ISO 9001 ISO 13485 e fi Bio Optica Milano S p A e via San Faustino 58 e 1 20134 Milano Tel 39 02 21 27 13 1 e Fax Acquisti Export 39 02 21 54 155 ro de p Ica Fax Assistenza Contabilit 39 02 26 41 74 48 e Fax Vendite 39 02 21 53 000 www bio optica it Filter replacement is required approximately every 60 to 120 processes based upon environmental factors and the use of the WCC Regardless of usage the charcoal filters should be changed at least once every six months Charcoal filters must be replaced with the required frequency as they may release toxic and contaminated vapors into the air when exhausted Exhausted filter waste is to be handled in accordance with the local regulations The processing chamber lid gasket is made of VITON rubber a DuPont trademark It needs to be periodically greased with TEFLON grease When replacing it use a plastic sharp tool not a metallic one to extract the gasket Before to insert a new gasket carefully clean the gasket housing slot The gasket replacement may be not easy due to the fact that to keep it in place its length is purposely longer than the slot in the lid The length excess must be distributed on all slot sides The insertion is normally possible with a little bit
3. The FTP300 is endowed with a password system that allows the access restriction to the main functions of the instrument Password general rules in case of wrong password the system shows a specific error message the password field accept up to 12 characters or numbers mix is allowed also empty spaces are admitted in the password composition Enable Disable Password This function allows the enabling and disabling of the Password If the password is not active the systems requires the definition of a new one If the password is active the system allows the disabling by typing the current password correctly We recommend to carefully keep note of the password before the activation because once activated there is no way to deactivate it without knowing it In case the password is lost it is necessary the intervention of our technical service to deactivate or retrieve it Password modification l The password can be modified any moment from this function but of course the modification is allowed only after the correct typing of the current password We recommend to carefully keep note of the new password before the modification because once modified there is no way to deactivate or modify it without knowing the current one In case the password is lost it is necessary the intervention of our technical service to deactivate or retrieve it Password protection map There are nine functions that can be protected by password
4. 6 3x32mm T Weight 180 Kg empty Dimension in mm H 1300 W 720 D 600 Running ambient temperature 10 35 C Storing temperature 10 50 C Relative Humidity Max 80 not condensing IEC1010 classification Protective Class 1 Pollution degrees 2 Overvoltage category Il 800V impulse 115V versions 1500V impulse 230V versions Max elevation 2500 mls Temperature controls precision 1 C Remote alarm socket and relay 48V DC AC 1A maximum Paraffin waxes Tanks Volume 4 reserve 2 5 L Paraffin waxes Melting Time Approx 8 hours Paraffin waxes Temperature Range 52 65 C default 60 Sample Processing capacity 300 standard cassettes SPC working temperature From ambient to 65 C Pressure range 600 1200 HPa Reagent Tanks Volume 10 2 5L Tanks for purge agents Volume 2 2 5L Printer Optional connected on USB port RMS Reagent Management System For all reagents purge agents charcoal filters WCC Wax Cleaning Cycle Efficient on site system no SPC filling Reagent Agitation User selectable from 5 to 30 frequency RFD RemoteFill Drain For reagents and purge agents Data backup On USB memory User interface LCD 15 colour monitor with Touch Screen Process Programs 18 including one for reverse processing Delay Up
5. This function has the same effect of the Reset Button on the rear panel of the instrument This function may be used to eliminate an alarm appeared during the instrument testing It can also be used to reset an alarm that for any reason was not possible to reset by the normal way POS TANK VR position VR position required Binary Data reserved to service technicians Input A Data reserved to service technicians Pressure SPC direct pressure in Hpa Etto Pascal Timer Time necessary to make vacuum and pressure in the SPC Hold Elapsed time between two pump starts during vacuum pressure tests ALARM Current alarm code CSQ Rev 120416 of 16 04 12 Page 55 of 64 MED ISO 9001 ISO 13485 E Dios www bio optica i Fax Assistenza Contabilit 39 02 26 41 74 48 e Fax Vendite 39 02 21 53 000 Bio Optica Milano S p A e via San Faustino 58 e 1 20134 Milano plica Tel 39 02 21 27 13 1 e Fax Acquisti Export 39 02 21 54 155 1 SPC C L SPC content it is set to the bottle number filled after a successful drain is set to 0 SPC last Last reagent filled in the SPC after a successful purge it is set to O SETP EHE EHE temperature setpoint TEMP EHE EHE temperature T MAX EHE EHE maximum temperature reached since the last reset SETP SPC SPC temperature setpoint TEMP SPC SPC temperature T MAX SPC SPC maximum temperature reached since the last reset SETP WWC WWC temperature setpoint TEMP
6. Process 18 REV ERSED p a It begins at the last non zero time on the steps list and moves backwards REVERSED a Itis not possible to insert a delay on the first step a The operator cannot modify its name a Its position in the list of the processes is always the 18 Except as specified above it is identical to the other processes therefore a It increments the RMS counters a All RMS rules are respected a At the end of the process user will be prompted to run a purge cycle a At the end of the purge cycle if during the last process at least one paraffin was used the WCC will be automatically started a At the end of the WCC the Reagent Management System will be started There are no particular restrictions to the use of this process however be aware that the reagent contamination will also be reversed CS Rev 120416 of 16 04 12 Q Page 25 of 64 MED ISO 9001 ISO 13485 IO www bio optica i ISO 9001 Optica ESG nav T EOP setti ay TMEL 6 00 Starts 5000 EMOTIVE LM Wednesda EE EN M 0700 0 A x MED ISO 13485 e Bio Optica Milano S p A e via San Faustino 58 e 1 20134 Milano Tel 39 02 21 27 13 1 e Fax Acquisti Export 39 02 21 54 155 ro a p rca Fax Assistenza Contabilita 39 02 26 41 74 48 e Fax Vendite 39 02 21 53 000 www bio optica it A Reagent Management System in a tissue processor is necessary to Optimize the reagents utilization Avoid the not
7. The lab manager must decide what to protect in relationship to real security reasons It is advisable to use the password only where it is really necessary The extensive usage of the password while increasing the instrument security may create problem to the day by day operations The password will be requested for the activation of each protected functions and can be requested many times during the usage of the instrument for example during the RFD it will be requested for each bottle managed that may result to be bothering but it is necessary to guarantee a real protection of the instrument especially when the work done is multiple and complex as it is during the RFD If the RFD is under password its usage will be protected during an execution of it from the RMS even if the RMS is not protected There is various level of protection that can be achieved with this system 1 Total protection all functions activated 2 Programming protection only the instrument programming functions are activated a Edit Process a RMS Setup a Parameters Setup 3 Mid level protection recommended only the functions more delicate are protected a Edit Process Rev 120416 of 16 04 12 Q A on Pu 1 hs Page 22 of 64 MED ISO 9001 ISO 13485 Bio Optica Milano S p A e via San Faustino 58 e 1 20134 Milano 6 Tel 39 02 21 27 13 1 e Fax Acquisti Export 39 02 21 54 155 ro qe O pti ca Fax Assistenza Contabilit 39 02 26 41 74 48 e Fax
8. it can be used for the fast processing of biopsies or for semi rapid processing of larger samples The FTP300 tissue processor recycles the air utilized to move the reagents to and from the processing chamber Two effective charcoal filters on the external air intake reduce the exhaust fumes to acceptable and safe levels The wax and reagent bottles can be rapidly removed and easily reinstalled in their housing slots The control devices hardware and software are based on the most up to date processing control technologies Up to 12 different programs can be permanently stored and be easily modified The 12 program is a special REVERSED program that is used to de process samples that have not had good infiltration During a run every step and action is displayed on the screen such as current step and function emptying filling etc processing chamber and wax heating chamber temperatures processing chamber pressure completion time and date and any other parameter necessary to simplify the use of the instrument In the event of power failures the computer saves all the data necessary to restart the process exactly where it was interrupted If the interruption happens during the wax stages particular precautions are taken to guarantee melting before any wax filling or emptying begins The user interface is based on Touch Screen technology Therefore there isn t any traditional keyboard all the instrument functions are activa
9. 9001 ISO 13485 SS e fi Bio Optica Milano S p A e via San Faustino 58 e 1 20134 Milano Tel 39 02 21 27 13 1 e Fax Acquisti Export 39 02 21 54 155 rO p Ica Fax Assistenza Contabilit 39 02 26 41 74 48 e Fax Vendite 39 02 21 53 000 www bio optica i work 24 7 all year long From this function it is possible to change the EHE default temperature The range goes from a minimum of 40 to a maximum of 70 degrees centigrade It is recommended to modify the default temperature only in case the factory set is too much different from the temperatures used in the process protocols Please keep in mind that to reach a temperature of 50 degrees for the reagents it would be necessary to set the EHE default temperature to at least 60 degrees 10 degrees over the protocol temperature cso Rev 120416 of 16 04 12 Page 21 of 64 MED ISO 9001 ISO 13485 e fi Bio Optica Milano S p A e via San Faustino 58 e 1 20134 Milano Tel 39 02 21 27 13 1 e Fax Acquisti Export 39 02 21 54 155 IO p rca Fax Assistenza Contabilit 39 02 26 41 74 48 e Fax Vendite 39 02 21 53 000 Wi ww bio optica i Please see the RMS chapter ahead in the manual A screen opens to display day month year hour minute and second Press on the field to be changed then increase or decrease its values with and keys Press CONFIRM to save changes and to go back to the previous menu Press ESC to abort changes and to go back to the previous menu
10. CAUSE SPC thermoregulating system damage SOLUTION No intervention by the user is possible Please contact our service department for assistance EXPLANATION Malfunction of the SPC temperature sensor CAUSE SPC temperature sensor failure SOLUTION No intervention by the user is possible Please contact our service department for assistance TE _ EXPLANATION A reagent fill was completed before the minimum allotted time The SPC will be drained and the process will proceed to the next step If the problem persists the process will be stopped CAUSE Very low quantity of reagent in a bottle reagent bottle quick connector not fully inserted into the female receptacle SOLUTION Check reagent bottle position and fluid levels If the problem persists contact the our service department for technical assistance EXPLANATION The rotary valve is out of position CAUSE The Rotary Valve motor failed or the Rotary Valve position sensor failed ey ESC CSQ Rev 120416 of 16 04 12 ST hey Page 51 of 64 MED ISO 9001 ISO 13485 e fi Bio Optica Milano S p A e via San Faustino 58 e 1 20134 Milano Tel 39 02 21 27 13 1 e Fax Acquisti Export 39 02 21 54 155 lo p ICQ Fax Assistenza Contabilit 39 02 26 41 74 48 e Fax Vendite 39 02 21 53 000 www bio optica i SOLUTION No intervention by the user is possible Please contact our service department for assistance EXPLANATION An essential comp
11. Check wax and reagent bottle levels Check the processing chamber for cleanliness Insert samples into the processing chamber Firmly close the processing chamber lid Select the desired program Enter date and time of program completion include a delay function if desired Enter the number of cassettes processed DODODDODOC6OU Follow the instructions to empty the last reagent Wait for complete emptying before opening the processing chamber Take samples out of the processing chamber Clean the SPC and lid of any wax residue Execute the purge program At the end of the purge program check that the SPC and lid are clean of any trace of wax or foreign bodies If necessary complete the cleaning manually Check the graph of the last process executed from the Main Menu press the key GPH to verify if the process has been executed properly and without any fault CODDDOP O eso cs E Rev 120416 of 16 04 12 Q Page 12 of 64 MED ISO 9001 ISO 13485 e Bio Optica Milano S p A e via San Faustino 58 e 20134 Milano 10 fi CQ Tel 39 02 21 27 13 1 e Fax Acquisti Export 39 02 21 54 155 p Fax Assistenza Contabilit 39 02 26 41 74 48 e Fax Vendite 39 02 21 53 000 www bio optica it The following picture shows the arrangement of the instrument tanks for reagents waxes purge agents and charcoal filters as seen from the instrument front C2 Charcoal filter for waxes C1 Charcoa
12. NOT FOUND icto oe terne dat ae eot Dr AA EE lio 52 59S SP TEMP LOW Li alia 52 60 WWG TEMP LOW corona ia t rre tette e tt en eei D eet be aa tati 52 61 WWC OVERTEMMD cr tree enr laici 52 62 TOSWWC MTS E E a a is E E N 52 63 PRESSURE NR aero a ar tu E ddr di 52 64 DRAIN NO PRESS ennan e t terre ii ri 52 65 DRAIN TIME OUT crt teta ei 52 66 5 SPC NOTEMPT Y aroun laziale 52 61 OVER FILL Punta a dt dia a a ia 53 70 89 COMERRORS ii 53 90 gt 93 I O ALARMS penisami dari iiaii EE EA EA TEA AA E A iai iadaaa ada 53 95 EHE OVERTEMP 53 O6 EAE TS OUT P 53 97 SERE TEMP LOW m 53 Alarms historical AMA Liceali RA ia 53 Service first aid instrument ASSISTANCE eee i 54 TouchS Calibf O 54 Dram SPO RR ido 54 VACUUMS SU NETT 54 Pressure tes iaa ii TT TETTE 54 luec AN 55 PARIS leo m M er 55 Data sre oH HH EE ES 55 acri 55 Alarms Feset 2 i eum a die bile dd ede 55 Service Menu abbreviation list i 55 PSO csQ Rev 120416 of 16 04 12 Page 4 of 64 MED ISO 9001 ISO 13485 e fi Bio Optica Milano S p A e via San Faustino 58 e 1 20134 Milano Tel 39 02 21 27 13 1 e Fax Acquisti Export 39 02 21 54 155 LO i p Ica Fax Assistenza Contabi
13. OFF Every time the RMS is set On or OFF all reagents counters are set to zero In this case it is recommendable that all reagents will be replaced prior to use the instrument again CSQ Rev 120416 of 16 04 12 Page 30 of 64 MED ISO 9001 ISO 13485 e Bio Optica Milano S p A e via San Faustino 58 e 1 20134 Milano Tel 39 02 21 27 13 1 e Fax Acquisti Export 39 02 21 54 155 ro p Ica Fax Assistenza Contabilit 39 02 26 41 74 48 e Fax Vendite 39 02 21 53 000 www bio optica it The purge reagents are also under the supervision of the RMS It is therefore sufficient that the RMS is active to have it recommend the substitution of the purge reagents every 3 to 9 processes The recommended number of processes for the substitution of the purge reagents are as follows Cleaning only the SPC 9 processes Cleaning the SPC and the baskets 5 processes The aforementioned quantity is valid for correct use of the instrument It is however contingent upon the manual removal of as much residual paraffin as possible from the lid and SPC before beginning the purge cycle Please note if the user desires to replace the purge reagents before their counter reaches the preset limit it will be necessary to reset the counter by the Zero Resetting Single Counter function The charcoal filters are also administered by the RMS In addition to the percentage indicator visible on the Main menu with 096 representing a new filter and 10096
14. Reagerits 2 rente tine bate stent vik eats steele nite vite ERR LL LY FED E ERRARE BL 30 RMS Define CM 30 RMS Counters Total Reset iere aee teer vetta ecd e Ek e dre he e Ade eg Ru 30 RMS Single Counter Reset roii n ke desta ce tk er ud de dee ea de ek dera PL d E de dk e ead ede Ro 30 RMS On O fixe EE 30 Other functions of the RMS setup menu i 31 Purge reagents limits Setting 12 enr ni IA dcinde eed deae D edades iaa dua sido e bd ede da cue 31 Charcoal filters lirits Setting 2 etie ese ede ai Neige eate eter Pere dll lira 31 WCC activation de actlvatlon nuire ede ade dr a Ste p dd tpe dug Lr die 31 Manual start of the WCG 32 QUADR Es 32 BETSeBidsu cT 32 Processing with the FTBPSOU intern t ect eter gcc E RATE E O 33 Checks and procedures before operating 33 Fast processes cin DLL IDOL LLLI DRUMS 33 Setting the program End tlme eite err estre eget dash alain nied ede eed 34 Br Aur intended tiie eaten lad Anda enna H 34 Process End time MEMOry i 35 Start from step different from the first enne nennen nere 35 Starting a process program ii 35 Interrupting Suspending the process ii 35 Opening the SPC lid during a process sssssssssseeeee enm eee nennen eer en nennen nnn nennen nnns 36 Instrument auto teStS aara OEE TEE AREE EEE EEEN eee nee eae eee nee eee r EEEE E
15. UPS on and off To switch OFF instruments equipped with a UPS it is not sufficient to turn OFF the main wall switch or disconnect the UPS power cord The UPS will keep the unit powered also with the power cord removed To switch OFF the FTP300 it is necessary to switch OFF the UPS and disconnect the FTP300 from the UPS supply power cord To switch ON the FTP300 it is necessary to reconnect the main power cord to the UPS and switch ON the UPS In case it would be necessary to open the rear panels of the FTP300 to operate on the internal parts we recommend to take particular attentions to ensure the real power disconnection from the UPS eso cso Rev 120416 of 16 04 12 hs Page 60 of 64 MED ISO 9001 ISO 13485 e fi Bio Optica Milano S p A e via San Faustino 58 e 1 20134 Milano Tel 39 02 21 27 13 1 e Fax Acquisti Export 39 02 21 54 155 IO p ICQ Fax Assistenza Contabilit 39 02 26 41 74 48 e Fax Vendite 39 02 21 53 000 www bio optica i The simple switching OFF of the main power wall switch and or the disconnection of the power cord may not be sufficient to ensure that the FTP300 is not electrically powered To ensure that the FTP300 is not electrically powered it is necessary to switch the UPS OFF Moreover for total safety when it is necessary to work on internal parts after the UPS is switched OFF we also recommend to disconnect the UPS power cord from the FTP300 UPS installation and maintenance F
16. WWC WWC temperature T MAX WWC WWC maximum temperature reached since the last reset Before calling our technical service please collect the following information a Type of instrument a Serial number a Software release a The number of any alarm that has occurred Please provide this information to technical service upon contact di ES ISO 9001 cso Rev 120416 of 16 04 12 Page 56 of 64 MED ISO 13485 e fi Bio Optica Milano S p A e via San Faustino 58 e 1 20134 Milano Tel 39 02 21 27 13 1 e Fax Acquisti Export 39 02 21 54 155 IO p rca Fax Assistenza Contabilit 39 02 26 41 74 48 e Fax Vendite 39 02 21 53 000 www bio optica it The thermostat controls include a maximum temperature cutoff switch to prevent overheating of WWC and SPC These devices do not prevent alarms but prevent overheating when primary control devices fail Do NOT use the instrument when an alarm indicates an abnormal temperature status In the event of an overheating it is advisable to switch off the instrument and disconnect the power cord In the FTP300 there is no danger of excessive pressures The pressure levels developed in the SPC are small and do not present any hazard Sometimes a light pressure can be present in the SPC at the end of a process The lid must be opened with care to avoid the possibility of eye injury by reagent vapors and splashing Always wear safety glasses when handling reagents Fuse re
17. and the SPC and the baskets helps to reduce the unavoidable cooling of the first wax that always happens especially with high loads of samples this phenomenon must be avoided especially when it is requested a short step time for the first wax because an excessive cooling may impede a good drain of it One or two mixing for each step are normally sufficient to ensure a good reagent movement around the samples More mixing are advisable for high sample loads At this regard it is necessary to consider that the SPC floor continuously receives a moderate heating from the WWC ceiling this heating creates a convection movement that results in a gentle but forced and homogeneous mixing of the reagents Furthermore that convection mixing is increased when the SPC heating is set ON cso cso Rev 120416 of 16 04 12 es Page 38 of 64 MED ISO 9001 ISO 13485 e fi Bio Optica Milano S p A e via San Faustino 58 e 1 20134 Milano Tel 39 02 21 27 13 1 e Fax Acquisti Export 39 02 21 54 155 IO p rca Fax Assistenza Contabilit 39 02 26 41 74 48 e Fax Vendite 39 02 21 53 000 www bio optica i Step Reagent Time TMP PV MX minutes 1 Formalin 60 A A 2 2 Dehyol 95 60 A V 2 3 Dehyol 95 60 A V 2 4 Dehyol 95 60 A V 2 5 Dehyol 100 60 A V 2 6 Dehyol 100 60 A V 2 7 Dehyol 100 60 A V 2 8 Xylene or Bio Clear 60 30 V 2 9 Xylene or Bio Clear 60 40 V 2 10 Xylene or Bio Clear 60 45 V 2 11 Wax 58 60 60 A 2 12 Wax 58 60 60 V 2 13 Wax 58 60 60 V 2 14 Wax 58
18. drain actions are performed in case the suspension happens during a fill drain the actions are completed to ensure that the samples will not dry in air The processing timer continues to work when the power is back if the step time is expired the following one is loaded Nc batteries charge status not considered in this action Please note as explained in other chapters to be recognized by the FTP300 computer the UPS must be enabled in the INSTRUMENT SETUP function In case of malfunctions of the communication system the UPS can be disabled The communication will be suspended but the UPS will continue to backup the FTP300 Attempts to enable the UPS when the UPS is not implemented will result unsuccessful In case of malfunctions of the UPS electrical power system its disabling from the Instrument SETUP may not be sufficient to allow the FTP300 a correct functioning in this case it will be necessary to call our technical service to either repair the UPS or physically disconnect it from the FTP300 Important notes 1 during a power failure if the UPS is used up to the complete batteries discharging less than 20 of residual charge all the bar squares would be red and the text will report the word FAIL after a short while the UPS will cease to sustain the FTP300 and will automatically shut down When the main power is back the FTP300 and UPS will restart automatically but it will take at least one hour before the bar will retur
19. have been an error in closing the chamber lid or something else easy to resolve Before to proceed please do what follow Remove all samples Check that the SPC does not contain any reagent residuals Check reagent and wax bottle levels Check that the bottles are correctly placed in their housing slots Check that the waxes are melted and if possible verify their temperature Check and clean the SPC lid gasket Start a purge to verify the correct functioning of the instrument SOLE When the cause of the alarm is unknown or uncertain it could be helpful to check the voltage and the quality of the main power line If the alarm persists please call our technical assistance In the top left of the instrument rear panel there is a green o red button Its purpose is the complete reset of the instrument software program It must be used under the following circumstances When for any reason the user is unable to reset an alarm in the usual way When a user faces unexpected situations that cannot be resolved by any other means To reset the instrument s memory that holds variables pertaining to the state and contents of the SPC possible processes in progress possible actions in progress and or alarms in progress The procedure for using the reset button is the following Y Switch off the instrument the switch is located near the main power cord v Press and Hold the reset button v Switch on the instrument and maintain the reset button
20. hole with a screwdriver or a pencil in the tape that seals the air intake on the top rear of the bottle B Connect the LCD screen The LCD screen is transported unconnected in a separate cardboard box The screen must be placed on the top left of the instrument housing The electrical connection is made by connecting the 2 connectors on the instrument rear panel One must be connected to the VGA the other in one of the USB C Connect the instrument to the main power The power connection must provide a voltage compliant to the voltage indicated on the label in the back of the instrument and the ground It is recommended that the instrument is plugged into a wall socket equipped with Ground Fault Circuit Interruption GFCI protection as an additional electrical safeguard In addition to the FTP300 anti blackout feature an uninterruptible power supply can be utilized to provide power in the event of power outages and some protection against power fluctuations line noise and power spikes It is highly recommended that the instrument be operated away from heat radiators stoves direct sunlight etc and moisture sinks drains etc Check list for using the instrument Check system time and date Set reagent and protocol names Check and set SETUP parameters including EHE default temperature Setup the RMS parameters Set protocols Install charcoal filters Fill wax and reagent bottles DLDODDODDD Z starting a
21. label is not consistent with the reality a mistake can be easily made For example if the reagent label Paraffin is assigned to the tank in position 4 which is not located in the wax chamber later when the RMS prompts the user to replace tank 4 the user will be instructed to put Paraffin in that position Clearly this would be an error Therefore it is important to carefully plan the entire reagent selection process prior to setting up the RMS The definition of the limits determines the frequency of reagent substitution It is possible to assign to each tank a limit based on the number of cassettes processed When this limit is reached or exceeded the RMS will require the substitution of the reagent for that specific tank If the limit is set to zero the RMS will never prompt the user to replace the reagent in that tank but its quality light will always be shown in red to remind that this tank is not managed by the RMS for a lack of limit It is advisable to fix the same limit to all the tanks of a group otherwise the RMS can ask for unbalanced substitutions with unpredictable results Moreover the limit can be proportioned to the length of a group in other words the longer is a group the higher can be the limit The Counters Total Reset selection allows the user to set to zero the number of processes performed and the number of cassettes processed including the DAF counter This function may be used when it is necessary to
22. more information about the RFD precision and its calibration The RFD can also be used in conjunction with the RMS during the reagents substitution It is possible but not recommendable to interrupt the execution of the RFD by pressing the ESC key Pressing again the ESC key the RED will be definitely aborted while pressing ENTER it will be re started In case of events that would have stopped half way the execution of the FTP300 for example alarms or mistakes on the tanks ositionin if some rea ent is left into the SPC it is possible to remove it It is highly advisable to take every precaution during the handling of reagents potentially flammable or toxic Despite the RFD operator safety increases thanks to the fill drain automation there is always some risk on handling flammable and or toxic substances We recommend to always have at hand a suitable extinguisher or at least to know the exact location of the closest one accordingly to the local rules of your country and laboratory CAUTION always check what follow gt Verify that the external pipes are well connected the quick couplers and are correctly inserted into the external tanks Verify that the external tank for the waste reagent would have at least 5 liters remaining capacity Verify that the tank with the new reagent would have at least 2 5 liters available for the filling and that the pipe end reaches the tank bottom Verify that the room in which the RFD is perf
23. of patience after one or two attempts csQ Rev 120416 of 16 04 12 SC hs Page 59 of 64 MED ISO 9001 ISO 13485 e fi Bio Optica Milano S p A e via San Faustino 58 e 1 20134 Milano Tel 39 02 21 27 13 1 e Fax Acquisti Export 39 02 21 54 155 ro ant p Ica Fax Assistenza Contabilit 39 02 26 41 74 48 e Fax Vendite 39 02 21 53 000 www bio optica it The FTP300 is equipped with USB ports in the rear panel for the connection of a printer To connect the printer please follows Windows and printer manuals In case of need please call our local service General description The UPS is an optional The FTP300 can be powered by an external UPS connected or not connected to the FTP300 by the RS 232 the difference consists in the following Connected UPS functions and advantages it can communicate with the FTP300 to manage the situations of power failure it reduces the power consumption in case of power failure it will avoid operations of fill and drain when the batteries charge is low during a power failure it allows the continuation of the processing for a time between 30 and 60 minutes thanks to the communication it is also possible to always know the situation of the batteries and the correct functioning of the UPS itself it acts as a filter to eliminate noises that can come from the electrical power line it will issue an alert and a resounding warning in case of power failure Usually a small UPS doesn t a
24. paying particular attention to the instrument setup instructions The warranty is invalid if the instrument is improperly operated Be certain to follow the instructions and recommendations provided by this manual The manufacturer is not responsible for damages resulting from improper operation or handling of the instrument Pay particular attention to the outside of the shipping container In the event of concealed damage save all shipping crates and packing material DO NOT unpack the instrument if damage is apparent Immediately notify the carrier of any damage and contact the shipper to initiate any claims The proper steps to be taken are 1 Open the top of the box 2 Lift the side walls out of the way 3 Raise the instrument to the vertical position 4 Remove the plastic layers that wrap the instrument 5 Carefully check the external condition of the instrument In the event of evident damage DO NOT connect the instrument Immediately notify the carrier and promptly contact the seller 6 For the setup of the instrument see the specific chapter Installation and Start up in this manual T Save the box and all the internal packaging in the event that the unit requires future shipment To transport the instrument perform the following steps 1 Remove all reagents waxes included from their bottles 2 Remove and close with the proper threaded cap the charcoal filter bottles put also some adhesive tape on the air inlet to
25. replace renew the reagents of all tanks and at all the effects restart the RMS The complete zero resetting does not include the counters for the charcoal filters or the tanks of the purge reagents These two counters can be reset using the RMS Single Counter Reset see next sub chapter Please note the counters total reset automatically occurs each time the RMS is activated or de activated When the definition of the reagents groups and or their limits are modified the system doesn t make any automatic reset of the counters That was decided to give to the user the maximum freedom but in case of modifications on the run it will be necessary to act carefully and eventually manually reset all or some of the counters see next sub chapter The Single Counter Reset selection allows the user to reset the counters of individual tanks This function is useful if the user decides to replace renew a reagent before the preset limit of a particular tank is reached The Single Counter Reset is also the only function that allows the operator to reset the counters of the charcoal filters and the purge reagents Please note The counters of the charcoal filters and purge reagents are not reset by the Counters Total Reset function Whenever the user replaces the purge reagents or the charcoal filters without being prompted by the RMS it will be necessary to utilize the Single Counter Reset to reset their counters This function turns the RMS ON or
26. representing an expended filter when the filters reach or exceed their preset limits the RMS will prompt the user to replace them at the same time he is prompted to replace reagents The charcoal filters should be replaced between a minimum of 60 and a maximum of 120 processes based upon the following factors Without the use of the WCC the filters should be replaced every 90 to 120 processes With the use of the WCC the filters should be replaced every 60 to 90 processes These values are somewhat approximate because can vary due to Environmental factors humidity temperature The duration of the processes The application of the vacuum or pressure on all the steps of process The frequency of agitation of the reagents If the FTP300 is operated in an area with high relative humidity if pressure and or vacuum is requested for most or all of the process steps if the reagents mixing in the SPC is set to the maximum frequency it will be necessary to set the limits for the charcoal filters substitution at or below the minimum values mentioned above Important Note If the charcoal filters are changed before the process counter reaches the preset limit it will be necessary to reset the counter with the RMS Single Counter Reset function on the RMS Setup menu The activation de activation of the WCC takes place on the RMS Setup menu De activation of the WCC is advisable when An excessive consumption of the charcoal fi
27. shown because may widely vary in relationship with the samples origin The step numbers here shown do not necessarily correspond with those actually used in the FTP300 they may change depending upon the kind of reagent used ese CSQ Rev 120416 of 16 04 12 lese Page 43 of 64 MED ISO 9001 ISO 13485 e fi Bio Optica Milano S p A e via San Faustino 58 e 1 20134 Milano Tel 39 02 21 27 13 1 e Fax Acquisti Export 39 02 21 54 155 ro ce p Ica Fax Assistenza Contabilit 39 02 26 41 74 48 e Fax Vendite 39 02 21 53 000 www bio optica it The overall samples fixation is normally done outside the tissue processors That is due also to the need to perform different fixation type and timing in relationship to the kind and size of sample The first step in formalin is not necessary if the fixation has been completely executed outside the tissue processor It can be useful to remember that the formalin can leave solid crystals that may be detrimental for some of the internal parts of the tissue processor and again this is worth for every kind and brand of tissue processor Thus we recommend what follow a Perform a complete fixation outside the tissue processor a Wash the samples in fresh tap water before to introduce them in the tissue processor a Set for the first step a low gradation alcohol or water a In case the fixation is completed in the tissue processor set a bottle of water in the following station that is worth especially for
28. the Reagent Management System eliminates the need to make annoying written annotations of reagent tank status This results in substantial time savings and eliminates the possibility of errors caused by multiple operators using the instrument Although explained later in more detail basically following the purge cycle and the WCC if activated the system will automatically prompt the user to replace the reagents that have reached their pre determined processing limit csQ MED ISO 13485 Rev 120416 of 16 04 12 Page 29 of 64 ISO 9001 e fi Bio Optica Milano S p A e via San Faustino 58 e 1 20134 Milano Tel 39 02 21 27 13 1 e Fax Acquisti Export 39 02 21 54 155 YO i p ICQ Fax Assistenza Contabilit 39 02 26 41 74 48 Fax Vendite 39 02 21 53 000 www bio optica i Defining reagents allows the operator to identify the type of reagent that is used in any single tank The labels to be used here must be prepared in advance in the instrument SETUP It is important to notice that the assignment of a reagent name to a tank in the RMS automatically updates the reagent names in the process programs However it is important that the reagent label corresponds exactly to the content of the tank defined during the setup of the RMS This is due to the fact that later when the RMS will prompt the user to replace a tank it will suggest the reagent that needs to be filled in the tank accordingly with what programmed here if the
29. the system suspends the process and perform the VACUUM RELEASE before the opening of the SPC lid will be possible The message line will then display Normalizing pressure in the SPC and after 10 seconds the SPC lid can be opened 5 If the processing chamber is not closed within 3 minutes an ALERT will occur 20 PROC SUSPENDED and a beeper will start to sound When the SPC lid is closed back the process is automatically resumed after a while or the process can be resumed by pressing the key ENTER 6 If the opening of the chamber is difficult DO NOT force it wait for the ambient pressure to be resumed Before and during the process the system verifies if there are the right conditions to start continue the work At the start of a process a series of parameters are checked if one of them is not conform to what is required to safely start the process the start is aborted and a message is shown so that the user can take adequate measures to remove the fault condition See also the chapter Safety devices Runtime test During the process another series of checks is performed continuously to ensure the safest sample processing For example before to fill a bottle the filling pipeline is tested to ensure that there isn t any clog or reagent of the previous step left in the SPC If the pipeline is not completely open Alert 6 and Alarm 53 are issued that specific bottle is jumped and the process continues on the previous bottle which will
30. time includes the reagent filling and draining times approx 3 minutes ISIMPEI atu es lel J The selectable reagent temperature range is O for ambient from 20 45 C The selectable paraffin temperature range is 52 65 C The Pressure Vacuum field allows the selection of the following options A ambient pressure V vacuum SPC pressure will be lowered to 600 HPa below ambient P pressure SPC will be pressurized up to 200 HPa above the ambient P V an alternating cycle with an 8 minute frequency of pressure and vacuum Varying the pressure in the processing chamber facilitates reagent infiltration into tissue specimens The following P V settings are recommended Biopsies Vacuum or ambient pressure Samples of normal size vacuum in every station Mix of biopsies and normal samples vacuum in every station Large samples cycles of pressure and vacuum in every station It is not recommended to simultaneously process samples of very different sizes esa csQ Rev 120416 of 16 04 12 v has Page 24 of 64 MED ISO 9001 ISO 13485 e fi Bio Optica Milano S p A e via San Faustino 58 e 1 20134 Milano Tel 39 02 21 27 13 1 e Fax Acquisti Export 39 02 21 54 155 IO p ICQ Fax Assistenza Contabilit 39 02 26 41 74 48 e Fax Vendite 39 02 21 53 000 www bio optica i Reagent agitation MIX The reagent mixing in the FTP300 is accomplished by bubbling air up from the bottom of the processing chamber Se
31. to 14 days 23 hours 59 minutes Process End Time management For every process program with auto memorization Purge 1 factory optimized 3 customizable Charcoal filters 2 easy substitution and safe handling Password User selectable multilevel Power failure device In the event of a power failure the processor restarts the process from the interrupted point csQ MED ISO 13485 Rev 120416 of 16 04 12 Page 63 of 64 Dio Optica Bio Optica Milano S p A e via San Faustino 58 e 1 20134 Milano 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 WWC Wax Warm Chamber EHE Enhanced Heat Exchanger SPC Retort Sample Processing Chamber RMS Reagents Management System WCC Wax Cleaning Cycle RFD Remote fill and drain system HPa Pressure unit of measure W Power unit of measure Watt A Current unit of measure Ampere V Voltage unit of measure Volt The product features reported in this manual are subject to change without notice FTP300 Service manual Touch Screen Monitor User Manual UPS User Manual optional The control software of this processor may be subject of modifications that may not result in visible differences from previous versions BIO OPTICA MILANO SPA VIA S FAUSTINO 58 20134 MILANO Tel 39 02 2127131 Fax 39 02 2153000 Web www bio o
32. to the instrument It can be done at the same time with the use of bottles refilled by the user the latter are simply thicker and stronger than the disposable bottles Advantages of using disposable pre filled bottles include a Faster reagent and wax replacement a Minimal user handling exposure to toxic vapors a Reduction of risks from handling flammable substances a Eliminates the technician time required to empty clean and re fill bottles Replacement of disposable bottles is easy Take the bottle containing the exhausted reagent out of its housing slot a Screw the special cap on the opening of the bottle a Unscrew the cap of the new bottle a Insert the bottle into its housing slot O The procedures to be followed regarding the recycling of contaminated reagents are the same adopted with traditional systems FTP300 bottles are made of completely recyclable 100 HDPE high density polyethylene Check with your local recycler about recycling HDPE with chemicals and wax residue The emptying and subsequent refilling of reusable reagent bottles must be done in accordance with all safety regulations for handling flammable and toxic substances The procedure must be performed with proper ventilation and away from open flames and or electrical circuits Bottles must be filled to the indicated level a volume of 2 5 liters When exchanging bottles use the special screw caps supplied with the instrument to avoid reagent spillage and f
33. to warm it up Please also read the sub chapter SETUP EHE activation Before to start a process program it is necessary to check and in case to set the program time and date of completion 09 02 2012 Ly R f Sa i 410 IATA EN SAMPLES 000 END TIME GT 00 Friday 10 02 2012 000 FORMALIN ono 0 v MO 02102 ALCOHOLOS 0100 a Y 1 NO EOP Day Friday 03 04 ALCOH aro Y E 04 04 ALO I 0100 0 y Delay 00 days OG hours O4min 5 05 ALCOHOL 100 0100 U V 06 06 ALCOHOL 100 0100 0 07 07 ALCOHOL 100 Uf00 U Y 08 08 XY FNF om a Y 03 00 XYLENE w a Y 10 10 XYLENE oro o i CANTA WAX GO 6100 69 12112 WAX 80 oro eg Y 13 13 WAX 66 0100 i 14 00 NO 00 00 Instrument READY In the above figure the top left window contains all the EOP parameters The indication of the number of cassettes is compulsory Please Note remaining in this screen for every minute that elapses the delay if any will decrease by one minute while the Program End time remains constant But if the delay time is set to or reaches zero the Program End time will increase By pressing on the fields their value can be changed The computer will automatically update the total processing time the date and time of completion and the fields that indicate the amount of the delay expressed in days hours and minutes The maximum delay is 14 days 23 hours 59 minutes It is not poss
34. week end processes More or less in every kind and brand of tissue processor the alcohols are subject to a forced dilution due to the water released by the samples that is the work done by the alcohols water removals from the samples or dehydration This unavoidable dilution is exploited in the RMS by Group to avoid the need to dilute the alcohol before their loading in the bottles In the processing program examples previously shown only 95 and 100 alcohols are used implying that a The tissue processor would be used with the RMS activated a Only at the very first alcohols loading the first three would be manually diluted in order to create a gradual increase of the alcohol concentration for example 50 80 95 theoretically only once in the life of the tissue processor practically every time for any reason it would be necessary to substitute all the reagents and reset the RMS a Please note that what suggested in point 3 is advisable but not strictly necessary because in several laboratories where the FTP300 is installed are used 95 and 100 alcohols without ever performing any dilution and with very good processing results cso Rev 120416 of 16 04 12 v hs Page 44 of 64 MED ISO 9001 ISO 13485 gt PO E DIO Y p Lica At the end of the process it is advisable to look at the graph of the last executed process in order to check if it was performed flawlessly We recall that to access the graph is it simply n
35. with the temperature required for the waxes during the process There are 5 wax bottle slots The one labeled R contains a spare bottle thus In Factory pre filled mode the R slot in the wax heating chamber is used to melt the paraffin prior its utilization as a replacement of a dirty bottle In Standard mode the R slot can be used to keep a wax bottle warm for immediate replacement of a dirty bottle CAUTION Since the normal wax temperature approaches the level at which a first degree burn may be possible we recommend the following Always wear protective gloves and eyewear when handling bottles of wax Always place a cap on wax bottles immediately after their removal from the wax heating chamber Handle them with care The wax heating chamber door is insulated and must be kept closed except when extracting or replacing bottles WARNING Never leave a slot without a bottle the bottles should always stay in their slots with their normal wax level of 2 5 It The absence of one bottle may cause an incorrect heating of the other bottles View of the wax warm chamber WWC CSQ Rev 120416 of 16 04 12 Page 17 of 64 MED ISO 13485 e Bio Optica Milano S p A e via San Faustino 58 e 1 20134 Milano Tel 39 02 21 27 13 1 e Fax Acquisti Export 39 02 21 54 155 ro od p Ica Fax Assistenza Contabilita 39 02 26 41 74 48 e Fax Vendite 39 02 21 53 000 www bio optica it Use of the WCC will reduce the c
36. 120416 of 16 04 12 hs Page 18 of 64 MED ISO 9001 ISO 13485 e Bio Optica Milano S p A e via San Faustino 58 e 1 20134 Milano Tel 39 02 21 27 13 1 e Fax Acquisti Export 39 02 21 54 155 ro sr p ICQ Fax Assistenza Contabilit 39 02 26 41 74 48 e Fax Vendite 39 02 21 53 000 www bio optica it From the SETUP menu it is possible to modify the most important instrument parameters except processing protocols in this menu are located all the parameters that do not require frequent access Here the main parameters can be modified After the modifications by pressing SAVE the new values are stored in the memory by pressing ESC modifications are discarded In any case it is necessary to press ESC to get out from the function In the first row on the top right of the PARAMS SETUP screen the current software version is shown For example SW version 5 5 FTP300 The only relevant parameter for the instrument user is the software version the others are related only to manufacturing internal use data Seven languages are available English French German Italian Spanish Czech and Turkish In the USA the date format is month day year In Europe the format is day month year Also the time is displayed in a different way Here it is possible to choose the desired format The ambient pressure decreases together with the elevation from the sea level approx 100 HPa less every 1 000 meter for the first 2000 meters It is impo
37. 16 04 12 hs Page 19 of 64 MED ISO 9001 ISO 13485 e fi Bio Optica Milano S p A e via San Faustino 58 e 1 20134 Milano Tel 39 02 21 27 13 1 e Fax Acquisti Export 39 02 21 54 155 IO p ICQ Fax Assistenza Contabilit 39 02 26 41 74 48 Fax Vendite 39 02 21 53 000 www bio optica i gt Qi VV VV SCLDOITIL This function allows the setting of the WWC temperature setpoint The range is 55 65 C It is advisable to set its value to the highest point compatible with the laboratory procedures Particularly it is necessary to set the value at least 2 C over the declared paraffin melting point For example for paraffin with a melting point of 56 58 C the correct WWC setpoint value would be 60 C To find the right value proceed as follow Using the RFD execute a fill in one of the reagent bottles With a system sufficiently precise 10mL take a measurement of the filled reagent Set the calibration value considering that every increase of 10 corresponds to 25 mL Repeat the filling with the RFD to check if the correction has given the right result The standard precision of the RFD is 1 which corresponds respect to the standard value of 4 liters to a maximum of 4 04 liters and a minimum of 3 96 liters The above cited values are compatible with the correct functioning of the processor in normal conditions PS To be recognized by the FTP300 computer the UPS must FTP300 can be with an optio
38. 60 60 V 2 Total Time hours minutes 14 00 Step Reagent Time TMP PV MX minutes 1 Formalin A A 0 2 Dehyol 95 20 A V 0 3 Dehyol 95 20 A V 0 4 Dehyol 95 20 A V 0 5 Dehyol 100 20 A V 0 6 Dehyol 100 20 A V 0 7 Dehyol 100 20 A V 0 8 Xylene or Bio Clear 20 30 V 0 9 Xylene or Bio Clear 20 40 V 0 10 Xylene or Bio Clear 20 45 V 0 11 Wax 58 20 60 A 0 12 Wax 58 20 60 V 0 13 Wax 58 20 60 V 0 14 Wax 58 20 60 V 0 Total Time hours minutes 4 20 CSQ Rev 120416 of 16 04 12 Page 39 of 64 MED ISO 9001 ISO 13485 e fi Bio Optica Milano S p A e via San Faustino 58 e 1 20134 Milano Tel 39 02 21 27 13 1 e Fax Acquisti Export 39 02 21 54 155 IO p Ica Fax Assistenza Contabilit 39 02 26 41 74 48 e Fax Vendite 39 02 21 53 000 www bio optica i Step Reagent Time TMP PV MX minutes 1 Formalin 60 35 A 3 2 Dehyol 95 90 35 V 3 3 Dehyol 95 60 35 VIP 3 4 Dehyol 95 60 35 VIP 3 5 Dehyol 100 90 35 V 3 6 Dehyol 100 60 35 VIP 3 7 Dehyol 100 60 35 VIP 3 8 Xylene or Bio Clear 90 35 V 3 9 Xylene or Bio Clear 60 40 VIP 3 10 Xylene or Bio Clear 60 45 VIP 3 11 Wax 58 90 60 A 3 12 Wax 58 60 60 V 3 13 Wax 58 60 60 VIP 3 14 Wax 58 60 60 VIP 3 Total Time hours minutes 16 00 csQ Rev 120416 of 16 04 12 Page 40 of 64 MED ISO 9001 ISO 13485 e fi Bio Optica Milano S p A e via San Faustino 58 e 1 20134 Milano Tel 39 02 21 27 13 1 e Fax Acquisti Export 39 02 21 54 155 IO i p ICQ Fax Assistenza Contabilit 39 02 26 41 74 48 e Fax Ve
39. A ONNA Har i ISO 9001 150 13485 e Bio Optica Milano S p A e via San Faustino 58 e 1 20134 Milano Tel 39 02 21 27 13 1 e Fax Acquisti Export 39 02 21 54 155 IO p rca Fax Assistenza Contabilit 39 02 26 41 74 48 e Fax Vendite 39 02 21 53 000 www bio optica it There are two types of alarms Alarms 1 through 50 are NOT BLOCKING ALERTS NOT BLOCKING alerts are only WARNINGS and do not interrupt the program execution because the cause of them is not critical for the process completion In this situation a program stoppage may produce worsen results than its continuation When an ALERT occurs the program continues and the screen displays the alert number and a brief explanation of it Upon the process program completion the cause of the alert can be determined and usually easily eliminated by the operator Procedures listed below for each type of alert alarm should be followed to correct the cause of the problem If the problem persists a call to the service department may be indispensable Alarms 51 through 99 are BLOCKING ALARMS These are true alarms and the process cannot continue as the cause of the alarm makes it impossible to proceed In the event of a BLOCKING alarm follow the instructions displayed on the screen to 1 Stop the acoustic alarm 2 Try to empty the SPC from wax reagent 3 Remove the samples 4 Reset the instrument After the reset the instrument is again ready to run a program The alarm could simply
40. Bio Optica Milano S p A e via San Faustino 58 e 1 20134 Milano Tel 39 02 21 27 13 1 e Fax Acquisti Export 39 02 21 54 155 IO lt p rca Fax Assistenza Contabilit 39 02 26 41 74 48 e Fax Vendite 39 02 21 53 000 www bio optica it The information provided in this manual applies only to the instrument indicated on the front page of this manual The instrument is clearly identified by a label applied on the rear of its body Identification label sample Bio Optica Mod FTP300 A_N c clics via San Faustino 58 ad Bio Optica Milano p A Ref FTP300 20134 MILANO ITALY S N xxxx xx Rating 100 240V 50 60Hz Power 1500W 20xx l Histology Tissue Processor A Be Y 4 MUN LIL Identification label symbols 20070 Rating Year of manufacturing It indicates the various voltages at which the instrument can work by varying the connection in the internal transformer another label in the proximity of the main power cable socket indicates the voltage at which the instrument is connected and at which it must work Manufacturer address CE CE mark In Vitro Diagnostic Device Caution Please read accompanying documentation Please read the instructions for the use Do not throw on domestic garbage please follow the local rules for special waste recycling and treatment CTUVus TUV Reinland of North America Conformity to United States and Canada safety prescriptions and stan
41. Faustino 58 e 1 20134 Milano Tel 39 02 21 27 13 1 e Fax Acquisti Export 39 02 21 54 155 IO p rca Fax Assistenza Contabilit 39 02 26 41 74 48 e Fax Vendite 39 02 21 53 000 www bio optica it The most common processing program has a stationing time of one hour for each step bottle Is suitable for the vast majority of histology samples moderate variations on the timing are sometimes adopted in relationship to specific needs and the kind of reagent used For example a the xylene substitutes may require a time longer than the xylene a higher reagent temperature allows shorter timing a also the use of vacuum may allows shorter timing The pressurization or de pressurization of the SPC allows a better sample infiltration Normally the use of vacuum de pressurization is sufficient to obtain a good infiltration for most of the samples and it is advisable in each station except for the formalin and the first wax The combined use of vacuum and pressure should be limited to the processing of very difficult samples big and or fatty The usage of P V with normal samples other than uselessly expend the processor components may cause undesired samples over processing The reagent heating in the SPC up to the maximum allowed temperature 45 C is advisable starting from the 2 3 reagents before the waxes to prepare the samples to the thermal jump from the ambient temperature to the 60 C of the waxes Moreover pre heating the samples
42. OLUTION No intervention by the user is possible If the problem persists contact our service department for technical assistance The alarms historical archive is under the SERVICE menu and consists of a list of the last 100 alarm occurrences Thanks to this feature a service technician can immediately recognize the problem its frequency the step in which it occurred and other information useful to solve the problem Alarms are displayed from top to bottom on the screen starting with the most recent one Use DOWN arrow to display older alarms Use ESC to go back to SERVICE menu If a printer is available the alarm list can be printed from the SETUP menu cso Rev 120416 of 16 04 12 Page 53 of 64 MED ISO 9001 ISO 13485 e Bio Optica Milano S p A e via San Faustino 58 e 1 20134 Milano Tel 39 02 21 27 13 1 e Fax Acquisti Export 39 02 21 54 155 ro p ICQ Fax Assistenza Contabilit 39 02 26 41 74 48 e Fax Vendite 39 02 21 53 000 www bio optica it With the service functions the following tests can be performed This function is used to calibrate the TOUCH SCREEN position in respect to the LCD screen After the activation of this function it is necessary to carefully follow the procedure indicated in the screen At the end of the calibration the system will automatically restart CAUTION in case of errors during the calibration the Touch Screen may not be working properly in this case it is possible to reset t
43. ON During the ending phases of the drain the pressure in the SPC is too low CAUSE The air pump or other pneumatic circuit parts failed SOLUTION No intervention by the user is possible Please contact our service department for assistance EXPLANATION During the drain the pressure has not reached the correct value CAUSE see alarm 63 SOLUTION see alarm 63 EXPLANATION The drain has gone over the maximum time allowed CAUSE see alarm 63 SOLUTION see alarm 63 EXPLANATION The user attempted to begin a process with the SPC either not empty or not cleaned from wax residue CAUSE The SPC is not empty The purge cycle compulsory after a process which involved waxes was not performed SOLUTION If the SPC is not empty drain it manually Enter the Service Menu and perform alarm reset and flag reset Return to the Main Menu and start the purge CS Rev 120416 of 16 04 12 Q Page 52 of 64 MED ISO 9001 ISO 13485 e fi Bio Optica Milano S p A e via San Faustino 58 e 1 20134 Milano Tel 39 02 21 27 13 1 e Fax Acquisti Export 39 02 21 54 155 IO p Ica Fax Assistenza Contabilit 39 02 26 41 74 48 e Fax Vendite 39 02 21 53 000 www bio optica i EXPLANATION An overfill of reagent or wax has occurred in the SPC Alarm sensed by overpressure during fill Normally an event of overfill is intercepted and solved by the anti overfill devices of the FTP300 in this case a simple alert is shown If the a
44. RA 36 Process completion tn nttent ttn AnAAASAAEAEAAAAEONEDEEEEAAAEOAEEEEEEEEREOSEEEEEEEEAEOSEEEEEEEER ESSEE ENERE Eent 36 Purging Me SPC stand ia E E E EE e EEE A EEO OEE E a 37 Advices and suggestion for processing iii 38 Un mec 38 Vacuum and PPESSUFE ck Oo 38 LGN et 38 iurc oo nn E A AE E T E A E PAT E A E E E A T 38 Example of protocols without EHE serasa eaa rtt ia 39 Short time process without the EHE een phe aa tdi 41 The FAST tissue processing with the FTP300 nennen nnne nennen nenne nnne nns 42 Reagents warm up by tho EHE orere iicaiieo E T ERTO EEEE 42 Protocols for Fast processing with EHE ii 43 mcus m X H 44 Alohols dilUtioni ev 44 Graphs of the last 30 processes executed i 45 Alerts and Alas oed ine 46 Managing ESL 46 Procedure Tor the Instrument reset ertt Lern te ipe dia 46 Graph ot the last 30 processes n nee died 47 ALERTS NOT BLOCKING vias al E ie ura lenin un CER RUNDE hb Pes Le dea e Ue I neice 47 d PW FAILURE EE 47 2 DIFFICULT DRAIN coo A dee d Pu sued etd 48 Rev 120416 of 16 04 12 Page 3 of 64 MED ISO 9001 ISO 13485 e fi Bio Optica Milano S p A e via San Faustino 58 e 1 20134 Milano Tel 39 02 21 27 13 1 e Fax A
45. UP usina aa 22 TIME end DAT Bi cies detest pete ray atleast oa dt tai ita 22 Password Setup rises eil uto ep these beet e stadia eerie ERE tati 22 Enable Disable PassWord acini nana e E tee te st n ete arcane ap doit 22 Password modifIcatloni ertt ede pe cete ecc tna 22 Password protection map eacus ttt hee nentes adde riarrangiata 22 REAGENT JEDE HE 23 die P 23 d Assiezm e eae 23 Programming process protocols iced ere pcc e t re pe Ur ER ECL eR UN ER COL e ER artes 24 peu deneaaeaee 24 Rev 120416 of 16 04 12 Page 2 of 64 MED ISO 9001 ISO 13485 e fi Bio Optica Milano S p A e via San Faustino 58 e 1 20134 Milano Tel 39 02 21 27 13 1 e Fax Acquisti Export 39 02 21 54 155 IO p ICQ Fax Assistenza Contabilit 39 02 26 41 74 48 Fax Vendite 39 02 21 53 000 www bio optica i Mz HR 24 TEMPEratures TEMP iii EE 24 Processing pressure P V ici iia 24 Reagentagitation MI a A A ii 25 Reagent pre heating column EHE iaia 25 Process 18 Reversed nee dcn ali aio 25 Reagent Management System RMS 27 RMS basic Concepts EEUU 27 The DAF Decreasing Aging Factor aaa 28 QUEDA 29 RMS Define
46. Vendite 39 02 21 53 000 I www bio optica Abort Process RMS Setup Parameters Setup Service Of course also to access the password map modification it is necessary to know the current password DOOD The most common reagent names are already set in factory Itis possible to modify them as desired Up to 40 labels are available here With this function various instrument tests can be performed Please see the chapter SERVICE This function is protected by a special factory set password and it is reserved to service technicians cso cso Rev 120416 of 16 04 12 hs Page 23 of 64 MED ISO 9001 ISO 13485 e Bio Optica Milano S p A e via San Faustino 58 e 1 20134 Milano Tel 39 02 21 27 13 1 e Fax Acquisti Export 39 02 21 54 155 ro a p Ica Fax Assistenza Contabilit 39 02 26 41 74 48 e Fax Vendite 39 02 21 53 000 www bio optica it This function can be accessed from the START menu Select a process protocol from the menu by pressing on the related icon The available protocols 18 A new screen will open showing the entire process content With the ARROW keys it will be possible to explore the entire table to select the field to edit Each field content can be varied by using the extended character keyboard or in same case by using the keys Each field can also be accessed by just pressing on it Press SAVE to save changes and exit the function Press ESC to abort the operation Below are explained limits
47. and characteristics of each field r EAGEI V I eagent names are labels prepared in advance as explained before They do not have an influence on the process The tank contents is decided in the RMS setup menu with the function Define Reagents Therefore it is necessary to pre define them in advance even if the RMS is not used The station time can be set from 0 to 99 hours The data control function can give unexpected results in case a number higher than 59 is entered in the field of the minutes For example entering 1 or 2 digits and moving over another field the entered number is interpreted as minutes if the number is higher than 59 it is transformed in hours and remaining minutes thus 60 will be transformed in 1 hour and 0 minutes 65 will be transformed in 1 hour and 05 minutes and so on Entering more than 2 digits the result may appear more strange when the last two digits entered are higher than 59 Thus the number 159 will be transformed in 1 hour and 59 minutes but the number 160 will be transformed in 2 hours 1 hour 60 minutes 2 hours The number 1099 will be transformed in 11 hours and 39 minutes and so on Initially this particularity may appear cumbersome but by respecting the principle of not entering more than 59 at the end of the time string nothing unexpected will happen If a time of 0 hours and 0 minutes is set the step will be ignored even if the other parameters temperature and vacuum are set The station
48. andling flammable reagents such as ethanol wear protective gloves and eyeglasses Use specific precautions in handling liquid waxes as they can cause burns The emptying and filling of reagent bottles must only be done only by qualified technicians Due to the presence of flammable substances inside reagents bottles it is recommended to Avoid smoking near the instrument Avoid using open flames near the instrument e g Bunsen burner DO NOT wear clothes that can create electrostatic charges while handling reagents wool synthetic fibers etc Contaminated reagent waste must be disposed off in accordance with all applicable local laws ordinances and safety standards Use only original spare parts supplied by the manufacturer or by authorized dealers DO NOT extract bottles replace reagents or do other maintenance operations when the instrument is operating To complete the knowledge on the instrument safety please read also the chapter SAFETY DEVICES near the end pages of this manual esa csQ Rev 120416 of 16 04 12 hs Page 8 of 64 MED ISO 9001 ISO 13485 e Bio Optica Milano S p A e via San Faustino 58 e 1 20134 Milano Tel 39 02 21 27 13 1 e Fax Acquisti Export 39 02 21 54 155 IO lt p rca Fax Assistenza Contabilit 39 02 26 41 74 48 e Fax Vendite 39 02 21 53 000 www bio optica it Before moving or transporting the instrument it is essential to carefully read this chapter
49. avoid charcoal pellets to get out 3 Transport the charcoal filter bottles separately from the instrument wrapped and securely closed in a protective nylon bag 4 If the original box has been saved follow the unpacking instructions in the reverse order using all the interior packaging to avoid serious damage to the instrument during shipping Before shipping please keep in mind that The instrument is fragile 2 The instrument is equipped with electronic parts 3 Contact with water and or any other liquid is to be avoided please ensure that the internal plastic protection bag that wraps the instrument is utilized 4 Transporting and storing temperature s must be between 10 C 50 C 5 Using the original box the instrument is to be transported horizontally 6 Transporting the instrument vertically is highly discouraged as its center of gravity is quite high cso cso Rev 120416 of 16 04 12 hs Page 9 of 64 MED ISO 9001 ISO 13485 e fi Bio Optica Milano S p A e via San Faustino 58 e 1 20134 Milano Tel 39 02 21 27 13 1 e Fax Acquisti Export 39 02 21 54 155 ro sr p Ica Fax Assistenza Contabilit 39 02 26 41 74 48 e Fax Vendite 39 02 21 53 000 www bio optica it The FTP300 can be used as a conventional vacuum tissue processor for overnight not fast tissue processing or thanks to the device EHE Enhanced Heat Exchanger capable to warm up the reagent during the transfer from the tank to the processing chamber
50. be reloaded with the time of the jumped step If two adjacent bottles are found faulty a blocking alarm is issued and the process is aborted At the end of a program the instrument maintains the last reagent in the processing chamber Press ENTER to empty the chamber After the reagent draining it is possible to open the SPC and take out the samples After the confirm that the samples have been taken out of the SPC the computer will prompt a message with a request to start the purge program If the program included paraffin steps the purge execution will be compulsory se Rev 120416 of 16 04 12 Page 36 of 64 MED ISO 9001 ISO 13485 e fi Bio Optica Milano S p A e via San Faustino 58 e 1 20134 Milano Tel 39 02 21 27 13 1 e Fax Acquisti Export 39 02 21 54 155 LO p rca Fax Assistenza Contabilit 39 02 26 41 74 48 Fax Vendite 39 02 21 53 000 www bio optica i The purge is necessary to remove wax residue from the process chamber It is always necessary if wax was used during the last process It is advisable to perform any case a purge even if in the last process no wax has been loaded into the SPC only in case the loaded reagents where formalin or alcohols the purge can be jumped without any problem The FIRST purge program has been set and optimized by the manufacturer and cannot be modified but there are other 3 purge programs that can be on some extent modified by the user It can be started anytime from the Ma
51. cold and solidified wax spots especially in the core of the SPC It may also happen that one of the cold solidified wax spots will clog the draining holes in the bottom of the SPC resulting in incomplete drain alarms This problem which is more or less common to any and each kind or brand of tissue processors is more probable with a full samples load with a low samples load for example 50 biopsies the problem doesn t practically exist any case it does not make any sense and it doesn t bring any benefit to the process to set step times shorter than 10 minutes A good timing choice for the first wax is a minimum of 1 minute every 10 samples thus 20 minutes for 200 samples and 30 minutes for 300 For the reasons described at point 5 the first wax is not subject to cycles of vacuum even when vacuum is set in the program that is due to the possible formation with high samples load of a sort of solidified foam on top of the sample baskets that will require long time for its melting The two phenomenons above described are more or less common to every kind and brand of tissue processor That is easily understandable by the fact that as said the first wax gets in contact with quite cold samples baskets and SPC walls The problem can be reduced if in the last reagent the temperature is set at 45 C In case of drain alarms in the first wax the most useful and efficient remedy is the first wax step time increasing Another sign of this problem can b
52. cquisti Export 39 02 21 54 155 IO p Ica Fax Assistenza Contabilit 39 02 26 41 74 48 e Fax Vendite 39 02 21 53 000 www bio optica i 3 SHORT IDRAIN m 48 Lusit xTM 48 5S FUN RILLE rana 48 O ABORTETED SIEP ien e dte cere ee bee oder oue te el eee 48 ELE NOW FOUND veces iad a ve eee eee tre cete eee ree bote ve eese testo eed 48 9 LONG IDRAING aia ET 48 uus euiuaem 48 10 PNY TIMEOUT eee eter Rete rte e eee Eon tte tue tes otia ee Deere ete E reve 49 i amp MTFAILURE lea 49 12 5 MZ IEAIBBRE intentare tete ee DN e uad oM id 49 ip eaizaEendq E 49 1o AORTA LEE tenete ciu rut d Mod LAM eL 49 20 PROC SUSP USER eee tede eee dee Dee e Eee e e rex eae desde epe anda esta peces a d epe 49 21 PROC SUSP LID 3 eee tee ee dee eee e eee e cec te ee ia Deest e punt 50 22 PROC SUSPUPS P EE 50 23 PROC SUSP INDEF sran iaaa a dd 50 230 RMS POSTPONED cuina r alia 50 32 RMS POSTPON PW ruen nuaa a a a a a Jaded aai a 50 ERA Meedsessp 50 40 BHODEV LACK sind i 51 ALARMS BLOCKING crnini ai datada 51 51 FILENO VACUO Meiscuuninanda rt daa 51 52 FILL TIME OU Tica ii ila 51 53 LINE CLOGGED uuu cia til aladdin 51 54 SPC OVERTEMP siii ii a a a a 51 56 TS OPO OU iria iii 51 56 SHORT FIL ii td dad 51 DEAR OU Ta rd cicle ias bad ds 51 56 A FILE
53. d and stored in the memory for future consultation If the RMS is postponed only once nothing bad can happen to the processing quality but in case of more than once postponing events the quality of the reagents may go under an acceptable level CAUSE The RMS execution has been postponed by the user SOLUTION Execute the RMS every time is requested by the system EXPLANATION The has been postponed due to lack of knowledge of the password See also Alert 30 CAUSE See alert 30 SOLUTION See alert 30 EXPLANATION The password has been mistakenly typed more than three times The alert is stored in memory for future consultation CAUSE See alert 30 SOLUTION Type the correct password if the password is lost please call our technical service to retrieve it CSQ Rev 120416 of 16 04 12 Page 50 of 64 MED ISO 9001 ISO 13485 e fi Bio Optica Milano S p A e via San Faustino 58 e 1 20134 Milano Tel 39 02 21 27 13 1 e Fax Acquisti Export 39 02 21 54 155 YO p Ica Fax Assistenza Contabilit 39 02 26 41 74 48 e Fax Vendite 39 02 21 53 000 www bio optica i EXPLANATION The drivers of the touch screen device are not responding properly CAUSE Hardware failure of the touch screen devices SOLUTION If the problem persists contact our service department for technical assistance meanwhile it is possible to successfully and safely use the FTP300 by connecting an AT keyboard in the rear panel see sub cha
54. d in the long term memory only if the program is actually started Obviously the instrument needs sufficient time to complete the selected process If it isn t possible to complete a process at the desired time the computer will propose a different End time Any case it is highly recommended that the user verify time day and date of process completion before starting a program If the End time is incorrect after the start of a program the only user option is to abort the process and restart it again with a corrected End time Process programs cannot be edited during processing Start from step different from the first At the start of a program press the UP and DOWN arrows note that the bar that highlights the step will move from the first step to every valid step every step is valid if its time value is greater than 0 This feature can be useful for example on partially processed tissue samples to re start their processing where it was interrupted After the process End time and the number of cassettes and baskets has been set the data can be stored in the memory by pressing SAVE then the program can be started by pressing START Pressing the ESC key the operation can be aborted After the final start the following information will appear on the screen a Each step of the process with time temperature pressure and mix data a The current step highlighted a In the highlighted step the time remaining will ramp down
55. dards csQ Rev 120416 of 16 04 12 Page 7 of 64 MED ISO 9001 ISO 13485 e Bio Optica Milano S p A e via San Faustino 58 e 1 20134 Milano Tel 39 02 21 27 13 1 e Fax Acquisti Export 39 02 21 54 155 ro a p rca Fax Assistenza Contabilita 39 02 26 41 74 48 e Fax Vendite 39 02 21 53 000 www bio optica it Severe damage can result if the instrument is connected to a power supply different from the rating stated in the identification tag placed on the rear of the instrument The instrument must NEVER be used without being connected to an appropriate and fully efficient ground connection If damages due to transport occur DO NOT use and DO NOT connect the instrument to a power source Contact our technical service This instrument has been designed to work 24 7 for this reason and for operative precautions the power switch is placed on the rear of the instrument Access to the instrument s internal components is reserved only to specialists trained in the service of the instrument e Always disconnect the processor from the electrical main source before accessing the electronics and internal parts BEFORE replacing fuses disconnect the instrument from the power source Always make certain to correctly engage the reagent bottles DO NOT open the processing chamber lid when the instrument is working without following the instructions contained in this manual Use specific precautions in h
56. e Bio Optica Milano S p A e via San Faustino 58 e 20134 Milano 10 fica Tel 39 02 21 27 13 1 e Fax Acquisti Export 39 02 21 54 155 p Fax Assistenza Contabilit 39 02 26 41 74 48 e Fax Vendite 39 02 21 53 000 www bio optica it Before using the instrument please carefully read this manual Please pay particular attention to the precautions that must be taken for user and product safety To avoid potential instrument damage do not use reagents different from those specified in this manual The warranty applies only if the instrument is used in the correct manner and in accordance with the information and advice provided herein The manufacturer declines all responsibility for possible damages to persons and or objects due to improper or inexperienced use of the instrument This instrument has been designed to be solely used in a Histology laboratory by on purpose trained technicians for processing specimen provided that is used accordingly with the instructions contained in this manual The FTP300 is a tissue processor designed for the following laboratory applications gt fixation gt dehydration gt paraffin wax infiltration of histological tissue samples Any other usage is expressly prohibited Failure to follow to these instructions may result in accidents damages to the instrument and accessory equipment personal injury eso cso Rev 120416 of 16 04 12 hs Page 6 of 64 MED ISO 9001 ISO 13485 e
57. e Bio Optica Milano S p A e via San Faustino 58 e 20134 Milano 10 p fica Tel 39 02 21 27 13 1 e Fax Acquisti Export 39 02 21 54 155 e p Fax Assistenza Contabilit 39 02 26 41 74 48 e Fax Vendite 39 02 21 53 000 www bio optica it BIO OPTICA FTP300 HISTOLOGY VACUUM TISSUE PROCESSOR USER MANUAL CSQ Rev 120416 of 16 04 12 Page 1 of 64 MED ISO 9001 ISO 13485 e fi Bio Optica Milano S p A e via San Faustino 58 e 1 20134 Milano Tel 39 02 21 27 13 1 e Fax Acquisti Export 39 02 21 54 155 LO p Ica Fax Assistenza Contabilit 39 02 26 41 74 48 Fax Vendite 39 02 21 53 000 www bio optica i General Warnings unico onc eter rhe reet dada adel den eee ee 6 Designated USE EET 6 Instrument type and instrument identification 02 0 eee eee eect eee ee nennen mne nnren enne nennen 7 Safety precautions filiera t 8 Unpacking transporting and handling eene enne nnne enne nennen nennen nnne 9 UNPACKIMO M T 9 Packaging and or preparation for transpott eene nennen nnne nennen inneren 9 E uveicunBe 9 Introduction to the FTP300 Processor ssssssssssesee eene enne enne rrn enne rra rra 10 General Bu 10 User interface and keyboard eene eene nere nen nnne nennen inen renn
58. e department for assistance CS Rev 120416 of 16 04 12 Q Page 48 of 64 MED ISO 9001 ISO 13485 e fi Bio Optica Milano S p A e via San Faustino 58 e 1 20134 Milano Tel 39 02 21 27 13 1 e Fax Acquisti Export 39 02 21 54 155 IO p ICQ Fax Assistenza Contabilit 39 02 26 41 74 48 e Fax Vendite 39 02 21 53 000 www bio optica i EXPLANATION the PNV Pressure Normalize Valve is the solenoid valve that provide to normalize the pressure inside the SPC making it the same of the ambient pressure if the pressure doesn t normalize within 3 minutes from the intervention of the PNV this alert is issued CAUSE Possible malfunction of PNV IOB wiring Possible clogging of pipeline between SPC and PNV SOLUTION Check and in case clean the small hole in the right wall of the SPC A small quantity of Xylene or xylene substitute can be introduced into the hole with a syringe if the clogging was due to a small drop of solidified wax after a few minutes the xylene may melt it try also to heat the SPC from the Service menu after 15 minutes or more try to execute the Pressure test from the service menu after the creation of the pressure press ENTER to release the it if the pressure normalizes the problem has been solved If the problem persists contact our service department for technical assistance EXPLANATION M1 is the name of the motor that provides the clockwise rotation of the VR Rotary Valve If the position of the VR d
59. e the systematic decrease of the level of the first wax bottle together with the increase of the level in the second wax bottle cso Rev 120416 of 16 04 12 Page 41 of 64 MED ISO 9001 ISO 13485 e fi Bio Optica Milano S p A e via San Faustino 58 e 1 20134 Milano Tel 39 02 21 27 13 1 e Fax Acquisti Export 39 02 21 54 155 IO p ICQ Fax Assistenza Contabilit 39 02 26 41 74 48 Fax Vendite 39 02 21 53 000 www bio optica i The FTP300 can be considered today the fastest not microwave vacuum tissue processor available on the market In this instrument up to 300 biopsies can be safely processed in about 45 minutes excluding fixation time using conventional reagents or using the various alcohol and xylene substitutes today available The processing speed up is obtained by a the pre heating of the reagents during their transfer from the tank to the SPC and without any delay up to a temperature very close to that selected for the SPC in the current program step a The heating of the reagents in the SPC up to 55 60 C a The reduction of the program steps used in the process down to 3 4 only for small samples a The optimization of the Reagent Management System For the execution of fast processes with the FTP300 it is necessary to employ the EHE most of its features have been explained in previous chapters The EHE is capable to warm up the reagents with a simple not direct contact thermal transfer without any r
60. e wax residuals that could remain in the SPC in case of an alarm The processing chamber temperature is automatically brought to 60 C This process may require up to 30 minutes This function displays the last 100 alert alarm From left to right are shown date time alarm step in which the alarm was issued Only 18 alarms at time are shown starting from the more recent With the key DOWN it is possible to show the remaining With this function it is possible to save on a USB memory all instrument data files later in case of need the saved files can be restored into the instrument memory The restore operation can be performed only by the service technicians Before to start this function it is necessary to insert in the USB port a blank formatted memory From this function it is possible to either copy into the USB memory a only the files with extension dat data files contained in the internal memory a all files contained in the internal memory For reasons related to the program files safety this two operations differ as follow a by simply activating this function the computer will copy only the files with the extension dat data files a By activating this function and keeping pressed the reset button located in the rear panel the computer will copy all files Be careful during these operations If the USB memory is not empty the space can be insufficient to backup all files Always use blank and formatted USB memories
61. ecessary to press the key GPH in the Main Menu screen the graph firstly shown is always the one of the last executed process The graph visualizes for each step what follow a The temperature of the SPC a The temperature of the WWC a The pressure of the SPC a Any occurred alarm or alert a The program steps There are two windows a The upper one is reserved to the temperatures and the alarms a The lower one is reserved to the SPC pressure In the event of an alert alarm their visualization is made by a small box with the alert alarm number inside it an arrow that points into the graph indicated the exact time in which the alarm occurred All of it together with the alarm archive in the service menu may be of great help on determining what really happened in case of a faulty event during the process The graphs other than to be helpful in case of an alarm may also allow the avoidance of a future faulty event For example a not sufficiently stable temperature or pressure graph may indicate a degradation of the temperature control system or the air pump performances In this case it will be possible to call our technical service for a preventive maintenance and avoid possible future alarms and the risks of not complete processes Please see in the following pages some graph examples Example 1 process successfully executed Bio Optical eck Vac AN E CSI Q JE MED IC
62. em is due to a fault on the SPC thermoregulation system no intervention by the user is possible If the problem persists contact our service department for technical assistance EXPLANATION during the reagent fill the filling time was too short the reagent level may be insufficient to cover the samples CAUSE Malfunctioning of the pneumatic system reagent level in the tank too low SOLUTION Verify the reagent level in the tank s If the problem persists contact our service department for technical assistance EXPLANATION The process has been suspended for the opening of the SPC lid or by user request CAUSE When the SPC lid is opened during a process or the user suspend it by pressing ESC and ENTER the computer temporarily halt the process execution When the SPC lid is closed back the computer automatically resume the process execution within 3 minutes from the opening The user can also manually resume the process if the lid is closed by pressing the key ENTER SOLUTION Close the SPC lid as soon as possible If the process is not resumed wait for the system to automatically check the SPC lid micro switch functionality that it will happen within 3 minutes from the lid closing If the micro switch will be found broken the system will automatically disable it and it will resume the CSQ Rev 120416 of 16 04 12 Page 49 of 64 MED ISO 9001 ISO 13485 e fi Bio Optica Milano S p A e via San Faustino 58 e 1 20134 Mi
63. en en nennen tenes 10 NIeLTTIILI MR 11 Wl 11 Installation and start up ttrt Annett EA EAAS EEEEEEEEEAASEEEEEEEEESEESEEEEEEEESEESEEEEEEEESEESE EEEE EEEn EEEE 12 Initial stage SEt UP 12 Before starting a process 12 At the end of a process i 12 EEE I PTN PO I AEA ON P EE N T VEE E A A T A T E E A T 13 Reagent tanks amrangelnerit nci cna ae E EE AAO ian 13 Compatible arem 13 Disposable pre filled bottles i 14 Filling reusable reagent DOttlles oil terrace A scade iaia 14 RFD Remote Fill and Drain system ine 15 Filling Wax Potos ius e 17 Wax Cleaning Cycle WCC estne nn 18 PFOCESSING CAPAGCILY e E 18 SETUP Of the instru Ment concione teet enne i xav d tv x RR RN d 19 x ssizu 19 Languages esas T 19 DateFormat agora e 19 Elevation ncc MS 19 BIB Ace REED 19 Ie alii 19 EU ae 19 SPG lid open Closed Sersor iii a alee sah re knee ets atti ate 19 WWG Setpoint eni sities ES 20 RFD ealibrations agraria a 20 UPS unit Uninterruptible Power Source i 20 Panel On Time screen saver time iii aLaaa liana 20 aen 20 EHE Setpoint nian a teen eene eh ecce taa 21 RMS SET
64. estored even in case of total loss of batteries charge but in case of wax steps a delay is introduced to ensure the wax complete melting If the electrical power is not restored within 5 minutes from the issuing of this alert the condition is switched to alert 23 and the instrument prepare itself for the complete switching OFF see alert 23 DE EXPLANATION The process has been indefinitely suspended due to the extended opening of SPC lid or lack of power when the instrument is equipped with the UPS and the batteries are too low see alert 22 CAUSE In case of suspension see alert 20 and 21 the process must be restored within 3 minutes over that limit the suspension is considered unwanted or accidental and this alert is issued to not mistakenly confuse the situation with the temporary suspension A beeping starts to signal the potentially faulty situation to the users This alert is also issued on instruments equipped with UPS when there is a power failure and the batteries charge is not sufficient to keep the instrument alive the process has been suspended and the instrument prepare itself to the complete power failure SOLUTION see alerts 20 21 and 22 EXPLANATION The RMS Reagent Management System is an automatic feature that periodically requests the user the substitution of certain reagents in relationship to pre determined plans The user may decide to postpone the execution of an RMS request but in this case an alert is issue
65. f the instrument In order to obtain a good reagent management it is necessary to set the RMS not only in terms of type of reagents used but also in terms of predefined limits that will trigger the reagent substitution set for each reagent tank In the FTP300 the limits are based only on the number of cassettes processed Those limits will be defined for each tank of reagent see next chapters it is here important to describe how the limits will be handled by the RMS 1 The limit maximum number of processed cassettes is defined for each tank independently from the group to which that tank is assigned 2 The number of processed cassettes will be then stored in memory for each tank and will be reset after that tank reagent renewal 3 Also the number of processes performed by each tank is stored in the memory but it will be used only to be shown under request of the operator also this counter is reset after that tank reagent renewal 4 The real effective counter is a third one its name is DAF Decreasing Aging Factor The DAF is calculated from v the number of cassettes actually processed Y the position of a tank in its group The concept is based on the assumption that in a group the reagent that will age more is the first one while the last is the one that will age less Thus inside a group the number of processed cassettes will be assigned to the DAF counters in a decreasing manner for example Group taken as example Cleari
66. f there are the correct conditions to safely and successfully operate If the test fails the requested action is aborted and an alarm is issued cso cso Rev 120416 of 16 04 12 hs Page 57 of 64 MED ISO 9001 ISO 13485 e fi Bio Optica Milano S p A e via San Faustino 58 e 1 20134 Milano Tel 39 02 21 27 13 1 e Fax Acquisti Export 39 02 21 54 155 IO lt p rca Fax Assistenza Contabilit 39 02 26 41 74 48 Fax Vendite 39 02 21 53 000 www bio optica it The tests are referred to a The temperatures of all the heated components those temperatures must be compatible with their correct operational ranges a The SPC lid closing if the lid is open an alarm is issued a The correctness of the signals from the pressure transducer a The correctness of the signals from the VR position sensor a The content of the starting process program if the program is incomplete or part of the data is lost or inconsistent the process cannot be started Q Various memory variables to make sure that a process is not started with the SPC not empty or dirty Active alarms no active alarm can be present at the starting of a process or purge a The UPS if a UPS is present and active and there is a power failure even if the instrument is working thanks to the UPS no process can be started because the UPS autonomy is limited to 30 or 60 minutes depending on the charge status of the batteries The SPC lid is heated independently from t
67. he SPC and WWC heating to avoid the building up of condensation underneath the lid when in the SPC is present a warm reagent the condensation will then fall down when the lid is opened creating an uncomfortable situation for the user The efficiency of the heating is sufficient to avoid most of the condensation only a few drops of reagent may still be present in the peripheral zones of the lid especially when the reagent inside the SPC is warm and the outside ambient temperature is particularly low under 20 C The temperature of the inside lower face of the SPC lid may reach 54 60 C so it can be uncomfortable at the touch but it is not anyhow dangerous The limited power of the heating element 22W compared to the mass and size of the lid makes it impossible the creation of dangerous temperatures Any case a safety thermostat 80 C max has been added to the heater to prevent any kind of over temperature The daily maintenance of the instrument consists of Cleaning the processing chamber Cleaning the processing chamber lid and gasket Checking the level of reagent and wax Checking that reagent and wax bottles are correctly positioned in their slots The following monthly maintenance is recommended gt Check the indicator of the Charcoal filter and in case is at 100 replace the filters gt Check for the presence of residues at the bottom of reagent and wax bottles When replacing reagents carefully clean their bottles
68. he calibration to his previous values by pressing the reset button placed in the back of the instrument for 12 seconds The reset operation must be executed from the Main Menu or from the Service Menu if none of these menus is visible it is necessary to switch the instrument OFF after 10 seconds switch it ON again keeping the reset button pressed until the Main Menu appears This function is used to empty the SPC in case for any reason for example a blocking alarm during a process reagent residues are still present into it Before to use this function it is important to remove the cause that creates the alarm for example by substituting the SPC lid gasket if the alarm was vacuum pressure related Activating this function firstly the processor checks the status of the rotary valve and the SPC last and SCP cont flags In case of inconsistency between the flags and the rotary valve position or in case the position of the rotary valve is unknown POS value to 99 the processor will require the operator to decide in which bottle drain the SPC content In this case it is solely responsibility of the operator to choose the right bottle an empty bottle or a bottle with a residue volume sufficient to contain the SPC content Pressing ENTER the processor will perform a normal drain procedure in case of blocking alarms the procedure will be stopped Caution do not use this function in case of not melted wax would be present in the SPC In this case i
69. ible to set an End time lower than what will result by adding the total process time to the current time Any delay programmed will extend the length of time the specimens will remain in the first reagent esi MED ISO 9001 ISO 13485 e fi Bio Optica Milano S p A e via San Faustino 58 e 1 20134 Milano Tel 39 02 21 27 13 1 e Fax Acquisti Export 39 02 21 54 155 rO i p Ica Fax Assistenza Contabilita 39 02 26 41 74 48 e Fax Vendite 39 02 21 53 000 www bio optica i Process End time memory A convenient feature of the FTP300 is the automatic recall of the End time Every time a delay is requested or updated thus every time an End time different from the natural one is set the computer stores the resulted End time it in the long term memory When a program is started the computer will propose recalculating the delay the same End time set during the previous start of that program If no delay was set the computer will propose for the End time the natural time current time total process time The delay necessary to end the process at the predetermined hour and or day is automatically calculated and displayed in the appropriate display field To reset the delay press CLR The delay will be set to zero and the delay memory will be erased The next time this program is started the End time will be the natural one current time total process time Any update of the delay End time here made will be store
70. ills the SPC with the content of the chosen bottle Then it drains the SPC through port 17 into an empty tank right side quick connector CSQ ls MED ISO 9001 ISO 13485 e fi Bio Optica Milano S p A e via San Faustino 58 e 1 20134 Milano Tel 39 02 21 27 13 1 e Fax Acquisti Export 39 02 21 54 155 rO i p Ica Fax Assistenza Contabilit 39 02 26 41 74 48 e Fax Vendite 39 02 21 53 000 www bio optica i This modality completion takes approximately 3 minutes it can be useful in case there is the need of a complete washing of the chosen bottle before to proceed to its filling Modality Only FILL The FTP300 fills the SPC with 2 5 L of reagent from port 18 left side quick connector Then it drains the SPC content into the chosen bottle This modality completion takes approximately 3 minutes Caution obviously in this last modality the chosen bottle must be empty before the start of the operation in case the fill is performed on a not empty bottle there will be a spill of reagents into the nearby bottles and possibly also outside of the instrument After the first few steps in which the computer asks for information regarding the bottle required for fill drain and confirmation about the presence of tanks connected to the ports 17 and 18 all the cycles are completely automated and the instrument can be left unattended until the operation ends See also sub chapter SETUP gt PARAM SETUP gt RFD calibration for
71. in Menu however at the end of a complete process the purge start is automatically requested by the system it can be jumped by pressing the ESC key but if a wax was loaded during the last process the following process start will be denied until a purge is performed Press ENTER to start the purge As well as in any other program the purge cycle can be aborted by pressing ESC and then ENTER within 3 second The bottles containing the purge reagents are labeled with P1 and P2 and must contain P1 xylene or substitutes the second P2 95 or 10096 ethanol The reagent must be substituted every 3 to 9 purge process see sub chapter Purge reagents limits setting The removal of wax residues before the start of the purge program is useful to extend the life of the purge reagents Avoid the use of sharp tools that can damage the processing chamber surface Even if the processing chamber is maintained at the last wax temperature till the execution of the purge cycle it is preferable to run the purge cycle immediately after the process The purge total time duration is 64 minutes The last purge step is the drying of the processing chamber from any alcohol residue This step is not critical and can be stopped at any time without damaging the instrument Jumping the drying step the purge total time is reduced to 34 minutes cso Rev 120416 of 16 04 12 Page 37 of 64 MED ISO 9001 ISO 13485 e Bio Optica Milano S p A e via San
72. isk of direct exposure of high energy thermal radiations for the samples as it may happen in the microwave tissue processors The risks of over or under processing are largely reduced and may happen only in case of big mistakes on the processing time programming At the opposite in a microwave tissue processor a few minutes more or less can be very harmful for the samples also the risk of hot spots typical of MW TP is not existent in the FTP300 Reagents warm up by the EHE As said to perform a fast process in the FTP300 it is necessary to use the EHE To be successfully used the EHE must be gt Activated in the instrument SETUP gt Param Setup if not activated the EHE will work any case but the process start will be delayed for the need to pre heat it gt Be selected in the process program for the steps for which it is desired its intervention gt For the same steps also an adequate temperature 50 60 C must be set in order to decrease the processing time thanks to the increased infiltration capability of warm reagent conversely to that the steps time can be proportionally reduced Thus at the start of a fast process it is necessary to be sure that the EHE temperature would be sufficient to warm up the reagent as said approx 10 C more than the desired SPC temperature for that step In case the EHE would be cold at ambient temp please allow about 20 minutes to warm it up Please also read the sub chapter SETUP g
73. ized as a command The EHE must be activated by this function in order to keep it at the default temperature of 65 C when the FTP300 is NOT processing to make sure that it will be always ready to perform a fast processing program During a process the EHE is set independently from the setup activation following this plan v Warm if in the running process one of the steps is scheduled to use the EHE Y At the opposite to save power the EHE is switched OFF if no steps in the running process are scheduled for using the EHE Y Switched OFF after the last step tank with EHE of the running process has been filled into the SPC Y Then as said at the end of a process the EHE is set ON to be ready to eventually perform a fast process but only if set active here By this function it is possible to set inactive the EHE in case it is known that the FTP300 will not never or for a long time be used for fast tissue processing In this case it is IMPORTANT to know that if a fast process is started there will be a delay up to 20 minutes for the EHE pre heating By setting the EHE inactive it is possible to save electrical energy please consider that the EHE power is 450 Watts when it is warm the power absorption goes down to approximately 200 Watts still this power has a significant impact on your laboratory electricity bill especially considering that a tissue processor is made to 3 CS d Rev 120416 of 16 04 12 Q Page 20 of 64 MED ISO
74. l filter for reagents P2 Purge agent 2 Ethyl Alcohol 95 100 P1 Purge agent 1 Xylene or substitutes 11 gt 14 Waxes 1 gt 10 Reagents FILL Filling Port for RFD system DRAIN Draining Port for RFD system The following reagents can be utilized in the FTP300 without any risk of damage Water Formalin Ethyl alcohol pure or denatured Methyl alcohol Xylene Xylene substitutes Paraffin Wax DODDDDODLDO CSQ Rev 120416 of 16 04 12 Page 13 of 64 MED ISO 13485 e Bio Optica Milano S p A e via San Faustino 58 e 20134 Milano 10 a fica Tel 39 02 21 27 13 1 e Fax Acquisti Export 39 02 21 54 155 p Fax Assistenza Contabilit 39 02 26 41 74 48 e Fax Vendite 39 02 21 53 000 www bio optica it The following materials are used in the construction of the FTP300 Reagents other than those listed above can be utilized in the instrument if they DO NOT damage the materials listed The manufacturer is NOT responsible for damages due to the use of reagents NOT listed here WARNING DO NOT use Acetone Benzene Toluene or Trichloroethane We also advise against the use of fixatives containing mercury salts acetic or picric acid as they may corrode the metal components of the instrument and shorten a component s useful life The FTP300 can utilize disposable ready to use factory pre filled reagent bottles It is very important to note that the use of pre filled bottles is possible without making any changes
75. lano Tel 39 02 21 27 13 1 e Fax Acquisti Export 39 02 21 54 155 IO i p ICQ Fax Assistenza Contabilit 39 02 26 41 74 48 e Fax Vendite 39 02 21 53 000 www bio optica i process execution Of course meanwhile the SPC lid must be left closed If the SPC lid is closed but the system shows that it is open the micro switch that controls the SPC lid status is surely broken or out of position Waiting for service it is possible to manually disable it by the instrument SETUP menu EXPLANATION The process has been suspended indefinitely cause the opening of the SPC lid CAUSE in case of process suspension the process MUST be resumed within 3 minutes after that time the suspension is considered accidental and this ALERT is issued to not confuse it with alert 20 SOLUTION see ALERT 20 EXPLANATION This alert is issued only in unit with the RS 232 connected UPS CAUSE The process has been suspended because during a power failure the UPS batteries went below 4096 charge The process is suspended to avoid that the energy would be completely lost during a drain or fill action with the risk that the sample will remain in air The instrument is set in a condition of power saving to increase the UPS batteries life SOLUTION Restore the electrical power if the power is restored before the batteries would be completely exhausted the process will be automatically restarted Any case the process will be restarted after the power is r
76. lect from the following frequencies 0 no mixing 1 one mixing every 30 minutes 2 one mixing every 20 minutes 3 one mixing every 15 minutes 4 one mixing every 10 minutes 5 one mixing every 5 minutes In this column it is possible to decide whether to warm up the reagent during the filling or not The reagent is heated using the EHE the end temperature of the reagent is decided in the column of the reagent temperature for the SPC column TMP The precision of the EHE is 3 C at the end of the filling during the stationing in the SPC the reagent temperature is further corrected toward the defined setpoint with a precision of 1 C The EHE precision is lower than the SPC because in the EHE the heating is made dynamically during the filling and approximately 2 5 liters of reagent are heated in 90 seconds despite this speed the heating is safely made and controlled If in this column the EHE is choosen the reagent instead to be directly loaded in the SPC is diverted through the EHE during the drain the reagent will any case not pass through the EHE In conclusion for fast processing it is necessary to set a temperature between 50 and 60 C in the column TMP and choose yes in the EHE column to activate it for that step More information are contained in the chapter Advices and suggestion for processing in the following of this manual ossesses all the characteristics of the other programs except
77. limit End of process 5 Tank Processed Cassettes DAF regressive counter 9 500 380 10 500 240 8 200 80 After process 5 the RMS will require the substitution of tank 9 because its DAF has exceeded the limit End of process 6 Tank Processed Cassettes DAF regressive counter 10 600 340 8 300 140 9 100 40 And so on The sequence here shown typical of a long overnight process would be surely influenced in the real world by variations in the quantity of cassettes processed and by the usage of fast short processes with only one tank per group In this case without using the RMS it would be quite complex to keep trace of the reagents unbalanced aging At the opposite thanks to the RMS the tracing of the reagents aging is automatic precise and reliable The RMS is not as rigid as it may appear if for any reason malfunction of a tissue processor component accidental loss of reagent from a tank etc it is necessary to substitute a reagent independently from the RMS requests that can be done by the RFD that will automatically reset the tank counters or manually in the second case it will be necessary to reset the tank counters by the RMS setup menu Of course during the next process that tank will be the last used in its group The FTP300 RMS is a system to punctually and exactly manage all reagents to guarantee a constant process and sample quality The use of
78. lit 39 02 26 41 74 48 Fax Vendite 39 02 21 53 000 www bio optica i Service ASSISTANCE MTM 56 Safety GOVICES iii aLaaa steed taste AR ER REED ee 57 Protectiorniagainstover heatllngs oii REIR redet bie E Reit ede dea penc th nda RANA pde deo ydo Roda 57 Protection against over pressures ii 57 Fuse replacement INCIP 57 Remote A Amn uu A eoa be cete un eae aee ee aea eee aver es eua seek ae rate ee ede ere ER Eus 57 Runtime TOS TEE 57 SPC lid heating E 58 Instrument maintenant aic erc Hk sene ica 58 Daily Maintenance EEUU 58 Petiodical maintenance enter eterne iii ada 58 Charcoaltfilters replacement cierre Te rene o ear 59 SPC lid gasket replacement edocuit cette ee e ee ica 59 ACCOSSOMOS MM EEUU 60 ic M H dessa 60 UPS Uninterruptible Power Source i 60 General descripto REC EE 60 Switching the UPS on and off 1 caridad eee ese eter e ce cu ridge bue dh dde ee s 60 UPS installation and maintenance i 61 UPS behaviour in case of power failure sss ener erre nennen nennen 61 important notes iano iaia M 61 Technical specifications sia TET 63 Units of measure and abbreviations i 64 Appendixes sico i RR ias 64 SoftWare Versions iii aia 64 itle estos date read deeded debi anid dedi pie need dee 64 CSQ Rev 120416 of 16 04 12 Page 5 of 64 MED ISO 9001 ISO 13485
79. ll not be necessary to start a purge cycle after the WCC However during the WCC the SPC lid must always stay closed The FTP300 is equipped with 2 stainless steel baskets of identical dimensions Each of the baskets can hold up to 150 cassettes The total processing capacity therefore is 300 cassettes As optional accessory is available a large basket that can hold big specimens or up to 350 STD cassettes As with all tissue processors good processing quality requires that certain guidelines be followed Processing every day large quantity of samples the reagents will need to be replaced more often Larger specimens require longer times at each station The use of vacuum or pressure vacuum cycles and reagent heating in each step of the process improves infiltration The daily replacement of the most contaminated reagent with subsequent shifting of the remaining reagents is preferable to the periodical substitution of all reagents In this way the process quality remains constant while in the latter method process quality varies from a maximum with all new reagents to a minimum last process before all reagents are replaced The FTP300 Reagent management System will minimize the shifting process work because it will not be necessary to physically move shift the reagent bottles into adjacent slots The RMS will automatically selects the most contaminated reagent first and the least contaminated reagent last cso cso Rev
80. llow the tissue processor to terminate a process in case of prolonged power failure but considering that most of the power failures are shorter than 15 minutes it reduces the possibility that a power failure will create a failure on the tissue processor functioning The FTP300 is endowed with a system to make it capable to overcome power interruptions but that system cannot guarantee 10096 success The system consists in a special memory capable to retain its content also when the computer doesn t receive electrical power in that memory every action of the tissue processor is stored every minute or less when the power is restored the FTP300 will re start the process exactly from where it was interrupted Unfortunately some of the power failures are also characterized by sudden oscillations of the voltage that can overcome the FTP300 electrical protection systems furthermore some of these events may be characterized by a timing fast transient particularly harmful for the computer s memory It is impossible to foresee how many times a power failure may disrupt the functioning of the FTP300 it depends also on the quality of the electrical power supply a fast transient or spike or a very short interruption between 0 1 and 0 5 seconds can be much more harmful than a prolonged interruption We highly recommend the installation of a UPS when the main electrical power supply quality is known to be poor and the interruptions are frequent Switching the
81. lters makes its use less advantageous than the paraffin savings This may occur due to a combination of the environmental and usage factors mentioned above The instrument is malfunctioning frequently Discontinuing use of the WCC will lower the workload for the FTP300 and may eliminate one possible source of malfunction cso cso Rev 120416 of 16 04 12 hs Page 31 of 64 MED ISO 9001 ISO 13485 If for any reasons the WCC has been interrupted or not allowed to start automatically it can be started manually by selecting Start Wax Purif Cycle on the RMS Setup menu If a process has been performed it is important to run a purge cycle before the WCC start From the RMS Menu it is possible to print the following information gt RMS status gt RMS settings It is always advisable to print the RMS settings and status before and after any meaningful change made on it A printout of the RMS status can be useful if there is a doubt that something didn t work properly during the reagent substitution and a check of the reagent situation and relative limits becomes necessary Using the RMS Using the RMS is certainly simpler than setting it It will be sufficient to follow its instructions when after the execution of a process and the purge and if any of the predefined limit has been exceeded the RMS screen will automatically appear The RMS can also be accessed manually by pressing RMS from the START Menu Bio O E M
82. minute by minute until the step is completed a On the top of the process window the name of the current program and the scheduled date and time of completion and other information are shown Once a program is started it is not required any other user intervention Processing step times and total time include the time necessary to fill and empty the SPC When a process program is running it is possible to suspend and later abort it but only during stationary phases for example not during filling and draining To suspend a process press SUSPENSION and within 3 seconds ENTER The instrument will suspend for 3 minutes every activity During this period it is possible to open the SPC lid Pressing the key ENTER the process resumes If the process is not resumed within 3 minutes the instrument will try to do it by itself If the SPC lid is not closed an ALERT will be issued and a beeper will alert the user of the mistaken situation When the process is suspended it is possible to abort it by pressing the key ESC and after 1 second pressing again ESC three times in sequence The SPC will then be drained after that the samples can be removed As said the interruption of a program is only possible when the reagent is in stand by in the processing chamber and not during the other steps filling emptying positioning the rotating valve etc Pad Ya md Rev 120416 of 16 04 12 Q Page 35 of 64 MED ISO 9001 ISO 13485 13485 e fi Bio Optica Milan
83. n a way to form an incremental scale that can bring the number of groups over the above mentioned total of 6 It is here important to note that the FTP300 RMS accepts a maximum of 8 groups It is highly advisable to not form too many groups 5 or 6 groups are the ideal situation for a successful reagent management and the samples best quality Particularly a maximum of two groups of dehydrants are sufficient to guarantee a correct incremental alcohol gradation But also a single big group of dehydrant has demonstrated to work fine provided that at the first start of the instrument a certain incremental gradation has been manually created Other important concepts of the FTP300 RMS are s The reagents are maintained at the end of every process to keep constant the specimens quality The FTP300 RMS most important concept is based on the assumption that the constancy of the quality is more important than the quality itself e The reagents used first in each group are those that are more polluted by the previous reagent and by the substances removed from the samples Accordingly those are the reagents that require the most frequent replacement e During the reagent maintenance the RMS will require the substitution of only one reagent per group also when more than one tank in that group has exceeded the pre defined limit e In a fast short process with only one reagent per group activated in the process program the RMS will select and use the tank
84. n to be green If after a total of 3 4 hours the bar is still not completely green a battery failure may be present In this case it is necessary to call our technical service to repair the UPS or substitute the failed battery CS Rev 120416 of 16 04 12 a Q Page 61 of 64 MED ISO 9001 ISO 13485 IL e fi Bio Optica Milano S p A e via San Faustino 58 e 1 20134 Milano Tel 39 02 21 27 13 1 e Fax Acquisti Export 39 02 21 54 155 LO p Ica Fax Assistenza Contabilit 39 02 26 41 74 48 e Fax Vendite 39 02 21 53 000 www bio optica i 2 As well as described at point 1 when the UPS battery charge is close to zero the UPS autonomously shuts off When the power is back the UPS and the FTP300 will automatically restart without the need to turn on any switch 3 The text FAIL in the UPS bar may be due to the lack of UPS batteries connection see previous chapter 4 For more information please consult also the UPS specific manual attached as external appendix to the present user manual cso Rev 120416 of 16 04 12 Page 62 of 64 MED ISO 9001 ISO 13485 Dio Optica Bio Optica Milano S p A e via San Faustino 58 e 1 20134 Milano 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 Rating 100 250V 50 60Hz not user adjustable Max power 1500 W Main Fuses 100V 220A 110V 16A 125V 12 5A 225V 28A 240V 8A
85. nal U be enabled by this function as well as it can be disabled in case of malfunctions Please note that both enabling and disabling are related only to the FTP300 computer gt UPS unit communications Even if disabled by this function the UPS will continue to supply power to the FTP300 but its state will not anymore shown and considered In case of an attempt to enable the UPS when the UPS is not installed the command will be refused In case of serious malfunctions of the UPS it may be not sufficient the software disabling in this case it is advisable or necessary to physically disconnect it from the FTP300 Please call our technical service to perform the repair or the disconnection After a period of not utilization of the touch screen the LCD screen is completely switched off to extend its life span and save energy This function allows the setting of the panel ON time the minimum time is 0 minutes function disabled screen always ON the maximum time is 90 minutes The tissue processor will continue to work perfectly even when the screen is switched off by touching any point in the screen surface it will be switched on in not more than 2 seconds and the FTP300 computer will emit a beep to confirm It is advisable to not press more than one time the screen surface and wait for the screen data and pictures to be visible before to perform any command The first touch will not be considered a command but any subsequent touch may be recogn
86. ndite 39 02 21 53 000 www bio optica i The FTP300 can perform short step time processes Reduced step times can be adopted for biopsies or small size samples The user will have to determine the best step timing basing his choices on past experiences and also taking care of what follow the efficiency of a vacuum tissue processor like the FTP300 is superior to that of a traditional carousel tissue processor the shorter are the step time the more is important the overall quality of the reagents and their correct maintenance the time indicated for each step program is inclusive of the fill and drain times normally 1 15 for the filling 230 for the drain for processing programs with a total time gt 5 hours 1 15 for the drain for processing programs with a total time lt 5 hours for the correct infiltration of small samples it is not strictly necessary the use of 4 waxes 3 would be sufficient it is advisable to jump the second wax The minimum step time is 5 minutes We recommend to not set short times in the first wax The minimum time for it must not be shorter than 20 minutes That is due as already explained above to the contact of the first wax with samples and baskets that are still quite cold In the following wax steps this problem doesn t exist anymore If the FTP300 is asked to drain the first wax after only a few minutes from the fill it may happen that the drain is not complete due to the formation of
87. ng Processed cassettes per process 100 Regressive percentage of the DAF inside a homogeneous group 100 60 40 30 20 15 10 minimum admissible Predefined limit for the 3 tanks of this group 300 cassettes End of process 1 Tank Processed Cassettes DAF regressive counter 8 100 100 9 100 60 10 100 40 End of process 2 Tank Processed Cassettes DAF regressive counter 8 200 200 9 200 120 10 200 80 gt pr CS d Rev 120416 of 16 04 12 Q Page 28 of 64 MED ISO 9001 ISO 13485 Bio Optica Milano S p A e via San Faustino 58 e 1 20134 Milano 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 o Optica End of process 3 Tank Processed Cassettes DAF regressive counter 8 300 300 9 300 180 10 300 120 At this point the RMS will require the substitution of tank 8 because its DAF has reached the predefined limit of processed cassettes after the substitution the counters of this tank will be reset In the next process the tank number 8 will be the last in the group and at the end of the process the counters will be as follow End of process 4 Tank Processed Cassettes DAF regressive counter 9 400 280 10 400 180 8 100 40 After process 4 the RMS will not require any substitution because none of the counter reached or exceeded the
88. nti overfill devices fail to correct the problem this blocking alarm is called and the process is stopped CAUSE Complete emptying of the previous reagent failed due to an incorrect solenoid valve opening or in case of paraffin temperature problems SOLUTION No intervention by the user is possible If the problem persists contact our technical assistance EXPLANATION Problems with the serial lines of communication CAUSE Hardware failure SOLUTION Try to switch OFF and ON the instrument If the problem persists contact our technical assistance EXPLANATION Problems with the I O systems CAUSE Hardware failure SOLUTION Try to switch OFF and ON the instrument If the problem persists contact our technical assistance EXPLANATION The temperature of the EHE is well above the set point CAUSE EHE temperature system failure SOLUTION No intervention by the user is possible If the problem persists contact our service department for technical assistance EXPLANATION The EHE temperature sensor is out of the correct range CAUSE EHE temperature sensor failure SOLUTION No intervention by the user is possible If the problem persists contact our service department for technical assistance EXPLANATION The temperature of the EHE is too low The process will be halted because the fast processing cannot be guaranteed CAUSE Incorrect working of EHE temperature sensor heater safety thermostat S
89. o S p A e via San Faustino 58 e 1 20134 Milano Tel 39 02 21 27 13 1 e Fax Acquisti Export 39 02 21 54 155 IO p rca Fax Assistenza Contabilit 39 02 26 41 74 48 Fax Vendite 39 02 21 53 000 Ww ww bio optica i There are situations in which the processing chamber lid CANNOT be opened when the SPC is under vacuum Others in which it MUST NOT be opened during fill and drain operations NEVER open the SPC while a program is running in a phase other than Processing Alarms may occur and the computer control system may abort the process Moreover potentially toxic or flammable substances may exit from the SPC The SPC lid is equipped with a micro switch that detects if the lid is open or closed thus if the lid is opened during a process the process it is automatically suspended But before to open the SPC lid it is BETTER to suspend the process by pressing the keys ESC and ENTER in sequence This will signal the system to normalize the SPC pressure and equalize it with the ambient pressure As said the SPC lid can be opened when the message line displays Processing Please take the following precautions 1 Suspend the process before to open the SPC lid 2 Close back the SPC lid as soon as possible 3 Respect all the safety rules about precautions to be taken when handling toxic or flammable substances 4 If the system is processing during a vacuum step after the lid handle opening it will be necessary to wait that
90. oesn t change within 10 seconds from the starting of the clockwise command this alert is issued This is not a blocking event because the instrument may continue to work by using the counter clockwise motor M2 CAUSE Possible malfunction of M1 wiring IOB SOLUTION No intervention by the user is possible Please contact our service department for assistance EXPLANATION M2 is the name of the motor that provides the counter clockwise rotation of the VR Rotary Valve If the position of the VR doesn t change within 10 seconds from the starting of the counter clockwise command this alert is issued This is not a blocking event because the instrument may continue to work by using the clockwise motor M1 CAUSE Possible malfunction of M2 wiring IOB SOLUTION No intervention by the user is possible Please contact our service department for assistance EXPLANATION during the process the temperature of the sample processing chamber did not reach the setpoint the process continues till the last reagent before the waxes If the problem persists before the draining of the last reagent before the waxes the process is stopped see alarm 60 CAUSE The thermo regulation system of the SPC is out of order or step time too short to allow the reagent to be heated at the desired setpoint when the EHE is not used SOLUTION If the problem is due to a mistaken programming change the step time or temperature If the probl
91. onsumption of paraffin by approximately 5096 The system is able to reduce paraffin consumption by removing the contamination of the preceding reagents The removal is accomplished by a flow of air bubbled through the wax containers The volatile reagents evaporate due to the heating of the wax containers during the WCC process The air bubbled through the wax carries these reagent vapors through the charcoal filter C1 where them are trapped Use of the Wax Purification Cycle while it will reduce consumption of waxes will also shorten the estimated life of the charcoal filters therefore we estimate that Without the use of the WCC filter life will be from 90 120 processes With the use of the WCC filter life will be from 60 90 processes These values are only estimates because they are influenced by Environmental factors humidity temperature gt The duration of the processes gt The application of the vacuum or pressure on all the steps of the process gt The frequency of reagent agitation The duration of the Wax Purification Cycle is about 30 minutes If the WCC option is selected it will begin automatically after each purge cycle but only when a wax has been used in the preceding process It is always possible to manually run a Wax Purification Cycle from the RMS Setup Menu independent of wax usage in the previous process During the WCC the waxes are not transferred from their containers the SPC will stay clean and it wi
92. or the installation and the maintenance of the optional UPS please carefully read and follow the instructions contained on the UPS manual UPS behavior in case of power failure Batteries status Action Nc Starting a process or a purge is not allowed independently from the batteries charge status Nc Independently from the batteries charge status when a process is automatically suspended due to a prolonged power failure it is not possible to manually restart it by pressing ENTER on the touch screen as it is possible to do with processes suspended by the user the process is kept in a suspended modality and the FTP300 is operated in power saving modality until the main power is back Nc To save energy the mixing and other minor actions are suspended since the very beginning of a power failure event 10096 The SPC heating is disabled except when in the SPC are loaded waxes The lack of heating of the reagents for a limited time doesn t prevent a good quality processing 10096 The temperature of the WWC is temporary reduced by 3 degrees if the process is far from loading waxes this temporary reduction significantly increase the UPS autonomy 10096 The creation of pressure and vacuum in the SPC is disabled the temporary lack of pressure or vacuum is not vital for a good quality processing but the UPS autonomy is significantly increased 4096 The process is completely suspended until the power is back No fill
93. ormed would be adequately ventilate the RFD doesn t have a recirculation system on the external tanks In case different kind of reagents are drained together into the external waste tank before to do it in order to avoid potentially dangerous chemical reaction verify their chemical and physical compatibility CSQ Rev 120416 of 16 04 12 Page 16 of 64 MED ISO 9001 ISO 13485 13485 e Bio Optica Milano S p A e via San Faustino 58 e 20134 Milano 10 fica Tel 39 02 21 27 13 1 e Fax Acquisti Export 39 02 21 54 155 p Fax Assistenza Contabilita 39 02 26 41 74 48 e Fax Vendite 39 02 21 53 000 www bio optica it In the FTP300 the paraffin waxes are contained in the same bottles used for reagents The advantages of it are the following a Easy handling and emptying of the wax bottles a Easy and economical substitution of the wax bottles a Possibility to use the instrument in Factory pre filled modality also for the waxes There is only one disadvantage bottles must be re filled with melted wax Attempting to fill them with flakes other than to be uneasy may produce under fill conditions that will cause a blocking alarm Furthermore the filling hose cannot be inserted into bottles 11 14 located in the wax heating chamber in presence of not melted wax The filling level is the same for reagents and wax 2 5 liters Wax bottles are placed in a special heating chamber that maintains a constant temperature consistent
94. ort 39 02 21 54 155 YO p ICQ Fax Assistenza Contabilit 39 02 26 41 74 48 e Fax Vendite 39 02 21 53 000 www bio optica i EXPLANATION difficult during the reagent drain The instrument had to perform two times the drain CAUSE Insufficient draining speed probably due to partial clogging somewhere in the hydraulic circuit SOLUTION Verify the SPC draining holes verify the bottle contents the presence of solid residue can slow down the draining EXPLANATION the duration of the reagent drain was too short CAUSE Insufficient level of reagent in the indicated bottle SOLUTION Verify reagent levels EXPLANATION the instrument is not able to create the proper vacuum in the processing chamber at the scheduled time The processor will not try anymore to create vacuum in that step and will go on with the program During the next step if scheduled it will try again CAUSE not perfect sealing of the lid gasket SOLUTION check and clean the lid gasket EXPLANATION excessive level of reagent in the bottle during the fill the overfill is recognized and the filling is stopped before it can produce a failure The process can continue without problems CAUSE Excessive level of reagent in the bottle SOLUTION Verify reagent levels EXPLANATION it is impossible to fill the content of a bottle into the SPC The bottle will be jumped and the following bottle in the process list will be used the time of the aborted ste
95. p will be added to the current one If the attempt succeeds the process can continue without problems In case also the following bottle cannot be filled the process is interrupted and the instrument indicates alarm 53 LINE CLOGGED CAUSE full clogging somewhere in the part of the hydraulic circuit of the jumped bottle SOLUTION Verify where possible the bottle pipeline EXPLANATION file not found or corrupted in the long term computer memory the recovery systems replaces the lost or incomplete file from a backup copy CAUSE transitory malfunction of the CPU memory SOLUTION No intervention by the user is possible If the problem persists contact our technical service EXPLANATION the time required to drain the SPC was excessive CAUSE Insufficient pressure in the SPC due to not fully efficient air pump an air leak in the pneumatic circuit or an air leak from the SPC lid gasket SOLUTION Check the SPC lid gasket contact our service department for other causes EXPLANATION during the process before the first wax step the temperature of the wax chamber dropped down to a level not sufficient to guarantee the wax melting the process continues till the last reagent If the problem persists before the draining of the last reagent the process is stopped see alarm 60 CAUSE The thermo regulation system of the wax chamber is out of order SOLUTION No intervention by the user is possible Please contact our servic
96. placement should be done only by qualified personnel Please note always disconnect the instrument from the main power line Never use fuses of a different rating and never try to repair damaged fuses The FTP300 is equipped with two line voltage fuses Fuses are placed into fuse holders located on the rear panel Rating 100V 20A 110V 16A 125V 12 5A 225V 8A 240V 8A Dimension 6 3x32mm Type delayed T After the instrument is powered if a fuse blows again do not try to substitute it another time A possible main electrical failure is undergoing in the instrument Call our service department for technical assistance The socket of the Remote Alarm connector has 3 contacts with the following disposition No alarm contacts 1 2 closed contacts 1 3 open Alarm active contacts 1 2 open contacts 1 3 closed For the location of the Remote Alarm connector please refer to the paragraph The Rear Panel at the beginning of the manual There are no electrical signals on the remote alarm contacts They are isolated from the rest of the instrument and can be used to activate an external device such as an Auto Dialer to call a pre selected phone number and relay the message that an alarm occurred Rating of the remote alarm connector and its associated electronics Maximum voltage 48V ac dc Maximum current 1A Before the start of a main function process or purge the instrument executes a series of test to verify i
97. pressed until the Main Menu screen appears cso cso Rev 120416 of 16 04 12 hs Page 46 of 64 MED ISO 9001 ISO 13485 e fi Bio Optica Milano S p A e via San Faustino 58 e 1 20134 Milano Tel 39 02 21 27 13 1 e Fax Acquisti Export 39 02 21 54 155 LO i p Ica Fax Assistenza Contabilita 39 02 26 41 74 48 Fax Vendite 39 02 21 53 000 www bio optica i After this operation the FTP300 may be ready for operations again but before to start any kind of process it is necessary to verify That the SPC is empty That the SPC is clean above all in reference to the presence of paraffin residue That the lid gasket of the SPC is clean and in its correct position That the instrument works correctly by performing tests from the service menu That an alarm present before the reset is not again on the display in this case will be necessary to witch off the instrument and call our service department with the exception of the alert 1 Before to start the purge cycle execute the instrument check list Run a purge cycle to verify that the instrument is fully operative VVEVVVVV In the next paragraphs each alert alarm and the appropriate solution is described In case of an alarm it can be useful to consult the graphs of the last 30 processes executed to verify if there is information that may allow to better understand why an alarm was issued See also the preceding chapters for more information on the graphs The alarms numbers are
98. pter Rear panel All instrument functions can be controlled also by a common PC keyboard EXPLANATION The instrument was unable to produce vacuum in the process chamber while attempting to fill from a reagent or a wax station CAUSE During the filling stage a leak in the pneumatic or hydraulic circuit occurred the air pump is not fully efficient or broken SOLUTION Check the SPC lid gasket Please contact our service department for assistance EXPLANATION The filling from a reagent or a wax bottle has not occurred in the allotted time CAUSE See alarm 51 SOLUTION See alarm 51 EXPLANATION Before to fill the content of a tank the system tests the tank specific portion of pipeline If the pipeline is clogged the system tries to fill the following reagent and issues the alert 6 ABORTED STEP in case also the following bottle would be clogged the system will issue this blocking alarm and will stop the process CAUSE The pipeline of the bottle that the system is going to fill is clogged or the previous reagent was not completely drained due to the pipeline obstruction or due to some problem in the hydraulic or pneumatic circuit SOLUTION Check the specific portion of pipeline of the tank involved in this alarm or the previous tank there may be debris or drops of solidified wax that clogs it EXPLANATION During a wax step the processing chamber temperature went over the allowed limit not to be confused with alarm 20
99. ptica it CSQ MED ISO 13485 Rev 120416 of 16 04 12 Page 64 of 64 ese ss ISO 9001
100. recommendable bulk substitution altogether once a week for example Avoid boring and not reliable paper records Avoid the manual movements of tanks to prepare the instrument for the next process for example by manually substituting the dirtiest tank of a group of reagents and shifting the other tanks backward Oooo In the FTP300 the usage of a good RMS is much more important given that as explained in other chapters the instrument can be used for fast and for slow processes with a different utilization of the reagents The reagent management is made more complex by the fact that while slow overnight processes use all the reagents fast processes use only a few reagents normally one per group Moreover in these fast short processes there is the need to use the best reagent for each group The concept of homogeneous group is based on the type of reagent and the kind of work that it does In the tissue processing 4 fundamental types of reagent can be identified X S Fixative Dehydrant Clearing Embedding X KS X fe k The dehydrants can be split in two sub groups low and high gradation Sometimes a tank with water is set between fixative and dehydrant to remove from the samples as more as possible fixative that in contact with alcohol can form noxious salts Thus considering that a group can be constituted by one tank usually in a tissue processor there are 4 to 6 groups Some users set the dehydrant i
101. rs during a process the FTP300 automatic power outage protection will allow it to resume the process program exactly from where it was interrupted The program resume will be performed according to the formula Steps 1 to 10 formalin alcohol xylene etc no special action the power failure time is considered processing time and the FTP300 continues as if nothing happened Steps 11 12 wax processing will pause for approximately as much time as the unit was without power waiting for the processing and the wax chambers to return to the proper temperature The power failure time and the related re heating time are NOT considered processing time CAUSES Loss of power in the lab a blown fuse or the simple switching OFF of the unit SOLUTION If the power supply doesn t resume check the electric network plug and cord If necessary replace the instrument fuses If the instrument is found fully operational but this alert appears too frequently e g more than once in a month it would be prudent to have the unit connected to its own power supply separate circuit and breaker To increase the instrument safety and reliability an uninterruptible power supplies UPS may be used to protect against power failures fluctuations and spikes CS a E Rev 120416 of 16 04 12 Q Page 47 of 64 MED ISO 9001 ISO 13485 13485 e fi Bio Optica Milano S p A e via San Faustino 58 e 1 20134 Milano Tel 39 02 21 27 13 1 e Fax Acquisti Exp
102. rtant to tell the instrument what is the level at which it is installed to avoid it to require the air pump to reach differentials of pressure levels of vacuum impossible to make especially when the elevation is higher than 800 1000 meter The displays of the ALERTS during the processing low level not blocking alarms can be enabled disabled The End Of Process beeping can here be enabled disabled If the printer is not installed this port must be disabled This way the program execution will be faster The SPC lid status is controlled by a sensor micro switch If the lid is closed but the system displays that it is open probably the micro switch is broken or out of position Waiting for service from this function the sensor can be disabled after that it is possible to continue to operate the instrument If the micro switch is disabled the SPC lid indicator will show the label DISABLE Please note that the sensor can reveal the lid complete opening but cannot sense its perfect closing Thus if the lid is simply turned down but the lock is not engaged the sensor may indicate lid closed but the instrument will not be available for processing The instrument will allow the process or purge start but soon it will issue an alarm caused by the impossibility to create vacuum or pressure in the SPC Please always check the correct lid closing and lock engagement before the start of any kind of operation Sed 9 cso Rev 120416 of
103. shown inside a small box and an arrow points to the graph to indicate the exact moment of the happening Checking also the alarm archive the chances to understand why an alarm occurred are greatly increased For example a If the wax temperature graph is unstable more than 1 0 C or if the temperature shown is different from the pre defined setpoint it is possible to suspect a failure of the wax temperature control system These temperature problems may also cause drain or fill alarms a Analogous situation may happen with the SPC temperature a The pressure graph allows the control of the air pump efficiency and the good sealing of the pneumatic circuitry In case of leaks the graph will be not stable to indicate an excessive frequency of the air pump start to restore the requested pressure into the SPC a A blocking alarm may be foregone by one or more alerts in the processing screen it is shown only the last alert alarm occurred in each step in the graph all the alerts alarms are shown even when happened in the same step That can be useful to understand what really caused the final blocking alarm a From the graph it is also very easy to verify if one or more steps has been jumped and the reason why it happened 1 PW FAILURE EXPLANATION the alert 1 indicates that there has been an interruption of power It may be due to a loss of power in the main line or merely due to the switching OFF of the instrument If the loss of power occu
104. t gt Is it possible but not recommended to suspend the RMS operations by pressing ESC then later restart by pressing RMS from the START Menu and complete it Check paraffin and reagent levels Check and if necessary clean the processing chamber Place the samples into the processing chamber Close the processing chamber lid firmly Select a program Edit date and time of process end TLUS SSS As said to perform a fast process in the FTP300 it is necessary to use the EHE Please also see the next chapters To be successfully used the EHE must be gt Activated in the instrument SETUP gt Param Setup if not activated the EHE will work any case but the process start will be delayed for the need to pre heat it gt Be selected in the process program for the steps for which it is desired its intervention gt For the same steps also an adequate temperature 50 60 C must be set in order to decrease the processing time thanks to the increased infiltration capability of warm reagent conversely to that the steps time can be proportionally reduced Thus at the start of a fast process it is necessary to be sure that the EHE temperature would be sufficient to cso cso Rev 120416 of 16 04 12 hs Page 33 of 64 MED ISO 9001 ISO 13485 Dio O plica warm up the reagent as said approx 10 C more than the desired SPC temperature for that step In case the EHE would be cold at ambient temp please allow about 20 minutes
105. t EHE activation csQ Rev 120416 of 16 04 12 Page 42 of 64 MED ISO 9001 ISO 13485 e fi Bio Optica Milano S p A e via San Faustino 58 e 1 20134 Milano Tel 39 02 21 27 13 1 e Fax Acquisti Export 39 02 21 54 155 rO p ICQ Fax Assistenza Contabilit 39 02 26 41 74 48 e Fax Vendite 39 02 21 53 000 www bio optica i Protocols for Fast processing with EHE Step Reagent Time Temperature P V Mix EHE Thickness 1mm 7 Unyhol 15 55 A 0 YES 10 Unyhol Plus 15 55 A 0 YES 14 Paraffin wax 15 60 V 0 NO Total time 45 Thickness 3mm 2 Water 10 ambient A 0 NO 3 Dehyol 7096 10 45 A 5 YES 4 Dehyol 9596 10 50 A 5 YES 6 Dehyol 100 20 DON A 5 YES 7 Dehyol 100 20 Dog A 5 YES 8 Xylene or Bio Clear 10 55 A 5 YES 9 Xylene or Bio Clear 15 55s A 5 YES 10 Xylene or Bio Clear 25 DON A 5 YES 12 Paraffin wax 15 60 V 5 NO 13 Paraffin wax 15 60 V 5 NO 14 Paraffin wax 30 60 V 5 NO Total time 180 Thickness 5mm 2 Water 10 ambient A 0 NO 3 Dehyol 7096 15 45 A 5 YES 4 Dehyol 95 20 50 A 5 YES 5 Dehyol 100 20 55 A 5 WES 6 Dehyol 100 25 55 A 4 YES 7 Dehyol 100 30 55 A 4 YES 8 Xylene or Bio Clear 20 55 A 5 YES 9 Xylene or Bio Clear 30 55 A 5 MES 10 Xylene or Bio Clear 40 Dow A 4 YES 11 Paraffin wax 15 60 V 5 NO 12 Paraffin wax 20 60 V 5 NO 13 Paraffin wax 25 60 V 4 NO 14 Paraffin wax 50 60 V 4 NO Total time 320 Notes sd fixation steps and times are not
106. t is necessary to first melt the wax with the service function SPC HEATING When the wax is completely melted the drain procedure can be started but being certain to choose a rotary valve position from 11 to 14 For safety reasons if case of presence of reagent the SPC lid must remain closed all time The instrument will create vacuum in the SPC this test must be done with the SPC empty and clean The SPC must reach a pressure of 600 HPa see Pressure field within 35 seconds see Timer field If the time exceeds 35 seconds the SPC lid gasket must be checked and cleaned If this action does not correct the problem contact our service department for technical service The instrument will create pressure in the SPC this test must be done with the SPC empty and clean The SPC must reach a pressure of 1200 HPa see Pressure field in a maximum time of 15 seconds see Timer field If the time exceed 15 seconds the SPC lid gasket must be checked and cleaned If this action does not correct the problem contact our service department for technical service cso cso Rev 120416 of 16 04 12 hs Page 54 of 64 MED ISO 9001 ISO 13485 e fi Bio Optica Milano S p A e via San Faustino 58 e 1 20134 Milano Tel 39 02 21 27 13 1 e Fax Acquisti Export 39 02 21 54 155 ro ce p Ica Fax Assistenza Contabilit 39 02 26 41 74 48 e Fax Vendite 39 02 21 53 000 www bio optica it This test allows to Check the SPC heating elements Melt th
107. t o6 The MAIN menu day by day operations will appear by pressing the START button left side The SETUP menu will appear by pressing the SETUP button right side A synoptic showing the most important instrument components is always visible on the left side of the screen esa csQ Rev 120416 of 16 04 12 hs Page 10 of 64 MED ISO 9001 ISO 13485 Bio Optica Milano S p A e via San Faustino 58 e 1 20134 Milano Tel 39 02 21 27 13 1 e Fax Acquisti Export 39 02 21 54 155 IO O pti ca Fax Assistenza Contabilit 39 02 26 41 74 48 e Fax Vendite 39 02 21 53 000 www bio optica i Modern LCD screens life is quite long but the lamps that provide screen s lighting are characterized by a much shorter life For this reason a screen saver device cuts off the screen power 30 after the last time somebody touched the screen surface A simple touch in any place of the screen surface will re start the power and the screen functions in approximately 1 second In case the screen would not wake up it will be necessary to switch OFF and then ON after 10 seconds the entire instrument from the main switch located on the rear panel If also this attempt will fail there is still the possibility quickly after the switching ON of the instrument to switch ON the screen by its small push button switch which is located on the right bottom of the screen frame It is recommendable to not touch the screen more than once to wake it up the first
108. ted by a finger touch At the bottom of the screen there is a window with a green background color used for messages to the operator Those messages inform and guide the operator about actions that can or must be taken to safely operate the instrument In the upper left side of the screen there is an icon with the letter i inside by pressing on it a window will appear showing the most important parameters and settings of the instrument SPC Sample Processing Chamber Pressure SPC Sample Processing Chamber Temperature WAX Wax chamber Temperature EHE Device for fast reagent heating Temperature RMS RMS Reagent Management System status enabled or disabled RMS reagents Status of reagents maintenance OK RMS executed NEEDED RMS not executed or not completely executed OFF RMS disabled EWD Device not active on FTP300 model WCC Wax Cleaning System status ON active OFF not active UPS Uninterruptible Power Source status UPS battery Battery pack of the UPS charge Charcoal Filters 0 new 100 exhausted Process Total number of processes executed Status Instrument status STAND BY waiting for a process start Purge Cleaning cycle status DONE executed SPC content The number on the left indicates the reagent currently filled into the SPC the number on the right indicates the last reagent filled in the SPC Alarms the number of the current alarm 6 6 6 6 tv t
109. touch it is not recognized as a command but only as a request to wake up the screen the following touches are recognized as commands and with the screen not yet visible may give unpredictable results oO RESET O SPEAKER a x USB POWER ISUPPLY FAN MER RS 232 POWER SUPPLY SOCKET REMOTE ALARM MAIN POWER SWITCH and SOCKET Notes Remote Alarm socket No alarm pins 1 2 closed pins 1 3 open Alarm pins 1 2 open pins 1 3 closed This socket is a low voltage connection maximum 48V 1A insulated from the rest of the instrument An Auto Dialer or other external alarm notification devices can be connected here Reset button keep it pressed during instrument boot to reset the instrument transitory memory Power Supply Switch it must be always at ON ese CSQ Rev 120416 of 16 04 12 Page 11 of 64 MED ISO 9001 ISO 13485 e fi Bio Optica Milano S p A e via San Faustino 58 e 1 20134 Milano Tel 39 02 21 27 13 1 e Fax Acquisti Export 39 02 21 54 155 IO i p Ica Fax Assistenza Contabilit 39 02 26 41 74 48 Fax Vendite 39 02 21 53 000 www bio optica i After the unpacking and the electrical connection to the main line the instrument is almost ready for the use there isn t any particular transport internal device that needs to be removed The next steps will be A Installation of the two charcoal filter on their slots C1 and C2 Remove the cap from the charcoal filter bottle and make a
110. umes After emptying dirty or encrusted bottles must be replaced with new ones Avoid cleaning them with solvents or similar products The o rings and all the openings on the quick couplers should be checked periodically for cleanliness If the quick couplers leak the o rings should be replaced If leakage problems persist contact our customer service cso Rev 120416 of 16 04 12 Page 14 of 64 MED ISO 13485 The Remote Fill and Drain allows the draining and the filling of the reagent bottles with the exclusion of the waxes without removing them from their slots The RFD connectors are placed in the front of the instrument as shown in the picture in the previous page In the left side there is the one for the FILL while in the right there is the one for the DRAIN To those ports it is necessary to connect the hoses with quick connectors and 90 elbows that will be placed inside the external tanks with the waste and the clean reagent Instrument READY The RFD can work in three different modalities Modality DRAIN and FILL The FTP300 fills the SPC with the content of the chosen bottle Then it drains the SPC through port 17 into an empty tank right side quick connector Afterward it fills the SPC with 2 5 L of reagent from port 18 left side quick connector Then it drains the SPC content into the chosen bottle This modality completion takes approximately 6 minutes 999 Modality Only DRAIN The FTP300 f
111. uter file is damaged or cannot be found and the error recovery system couldn t correct the problem CAUSE Computer malfunction SOLUTION No intervention by the user is possible Please contact our service department for assistance EXPLANATION The SPC chamber temperature was too low during the drain of a wax step the drain cannot be completed The process will be stopped to avoid other problems The samples will be left in wax till the user intervention CAUSE Incorrect working of SPC temperature sensor heater safety thermostat SOLUTION No intervention by the user is possible Please contact our service department for assistance EXPLANATION At the moment of the fill of a wax step the temperature of the WWC chamber was too low The process will be halted because the fill cannot be guaranteed CAUSE Incorrect working of WWC temperature sensor heater safety thermostat SOLUTION No intervention by the user is possible Please contact our service department for assistance EXPLANATION The temperature of the wax chamber is well above the set point CAUSE WWC temperature system failure SOLUTION No intervention by the user is possible Please contact our service department for assistance EXPLANATION The WWC temperature sensor is out of the correct range CAUSE WWC temperature sensor failure SOLUTION No intervention by the user is possible Please contact our service department for assistance EXPLANATI
112. with the best youngest reagent independently from its position inside a group meaning for position both the real position and the programmed step position of that tank e Once the RMS is activated it is not anymore possible to consider the physical position of the tanks or Rev 120416 of 16 04 12 cse has Page 27 of 64 MED ISO 9001 ISO 13485 e fi Bio Optica Milano S p A e via San Faustino 58 e 1 20134 Milano Tel 39 02 21 27 13 1 e Fax Acquisti Export 39 02 21 54 155 IO i p Ica Fax Assistenza Contabilit 39 02 26 41 74 48 Fax Vendite 39 02 21 53 000 www bio optica i their position in the program STEP It will be necessary to fully trust the instrument and follow its instructions regarding the substitution of the reagents When there is a doubt that something is not working properly for example in case of poor tissue quality it will be necessary to replace all the reagents and use the counters reset functions to reset the counters In this case it is recommended to reconsider the RMS settings and decrease the limits until a substantial tissue quality is obtained It is not possible to foresee a RMS standard setting The RMS ideal setting is strictly related to the kind of usage done with the FTP300 type and quantity of fast short and slow long processes performed type of reagents type and quantity of samples processed that ideal setting may be experimentally found after a few weeks of continuous and regular use o

bio-optica – ftp300 histology vacuum tissue processor user manual

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bio-optica &ndash; ftp300 histology vacuum tissue processor user manual

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bio-optica – ftp300 histology vacuum tissue processor user manual