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SERENA P GB-R04 del 03-07-17 

00/ Per Bertani/ Manuali d’uso Serena/ Serena con stampante                                                                                                                             

97/99

 

 

15  DECLARATION OF INSTALLATION 

 

WARRANTY CERTIFICATE AND STATEMENT OF 

SERVICE INSTALLATION 

INSTALLATION DATE  …………………………………… 

 

Technical course of installation, repair and maintenance

 

The technician who has carried out the installation of the sterilizer has previously attended 
the technical course and has been authorized by the manufacturer's for the installation and repair of 
such equipment

 

Installation according to the manual of use and maintenance

 

The technician who has carried out the installation of the sterilizer claims to have complied with all 
conditions that allow the correct installation of the device according to the use and installation manual.

 

Instruction to the user, functioning and maintenance

 

The technician further declares to have properly instructed the user on the functioning of the 
machine with the support of the instruction manual and he declares to have explained the timing 
of scheduled and daily maintenance. See paragraph 11 MAINTENANCE. 

Instructions to the user on the warranty conditions 

The technician has also shown the warranty conditions as described in the use and maintenance 
manual.

 

Warranty form

 

The  technician  declares  to have  attached  to this  form  the  warranty  model,  which  has  been  carefully 
filled in. 

 
 

 

WARRANTY CERTIFICATION 

 

 

 

EQUIPMENT: 

 

Incollare etichetta matricola

 

 

The undersigned dealer certifies that the warranty conditions have been read and that the 
autoclave has been delivered and operated in accordance with the provisions of the manufacturer. 
 

Installation date:…………………………………. To the Doct: ………………………………………….…………………. 
 
Address: ……………………………………………..….……………….……..……Post Code ………………………....…           
 
City: …………………………………………………………..Country……………………………………………………….. 

 

 

STAMP AND SIGNATURE OF THE DEALER 

 

STAMP AND SIGNATURE OF THE DOCTOR/MANAGER 

 

To be completed by the technician who has made the installation of sterilizer according to the DDM  93/42/CE replaced 
by Directive 2007/47/CE-D.lgs. 25.01.2010 n°37, attachment I.  

Copy for the medical. 

 
 

Содержание SERENA 18

Страница 1: ...MEDICAL DEVICES SECTOR USER MANUAL AND MAINTENANCE Language English Cod 9925 STEAM STERILIZER SERENA 18 23 P THE NEW GENERATION...

Страница 2: ...MENT INSTALLATION USE etc is part of the product itself and it must be delivered to the user who has to store and carefully read it before starting each step of the service provided by the machine Do...

Страница 3: ...RGENCY STOP AUTOCLAVE 13 1 15 CONDUCT OF MACHINE BY USER 13 1 16 RESIDUAL DANGERS INFORMATION 13 1 17 FAILURES MALFUNCTIONS OR OTHER INCONVENIENCES 14 2 UNPACKING 15 2 0 SUPPLIED ACCESSORIES standard...

Страница 4: ...7 1 DRYING ONLY 45 7 2 EXTRA DRYING 46 7 3 LABELS EXPIRY DATE 46 7 4 START POSTPONED CYCLE 46 7 5 NIGHT CYCLE 47 7 6 OPENING DOOR 47 8 SETTINGS 48 8 0 PRE HEATING 48 8 1 DRYING TEMPERATURE 48 8 2 DAT...

Страница 5: ...REPLACEMENT OF THE GASKET licensed technician code 5030 65 10 0 9 REPLACEMENT OF THE TRANSDUCER licensed technician code 5186 65 10 0 10 REPLACEMENT OF THE ELECTRONIC BOARD licensed technical code 518...

Страница 6: ...hoever takes his place that person must MANDATORY read UNDERSTAND all the instructions in this U M M The manufacturer is not liable for any direct or indirect damages caused by people who had used the...

Страница 7: ...low type A and B unwrapped wrapped in single and double envelope They are also used for materials and tools that can come into contact with blood and or body fluids Usage environments may be hospitals...

Страница 8: ...the equipment in normal working conditions Surveillance will still be constant and will act promptly in cases of anomalies All our equipmentare subject to continuous technological development We must...

Страница 9: ...TS AND USE 18 THE U M M DUPLICATION IS RECOMMENDED AUTHORIZED BY THE MANUFACTURER FOR THE INTERNAL USE ONLY AND IT IS AVAILABLE FOR THE PERSONAL AND ENABLED USER KEEP THEN THE ORIGINAL COPY IN A SAFE...

Страница 10: ...that at its own sole discretion were to be originally defective with only the reimbursement of travel expenses incurred by the technicians of the Service Centre at doorstep or totally free if the equ...

Страница 11: ...exposed areas must be taken by the purchaser USE IN EXPLOSIVE ENVIRONMENT The device cannot be used in any way in the environment where there is a risk of explosion or in a potentially explosive envi...

Страница 12: ...ecommend the use of special cabinets equipped with ultraviolet lamps which are perfect for this specific use The support trays and trays must be always present In the room At the end of the cycle the...

Страница 13: ...e operator must take prompt action on the connection socket plug off grabbing the plug WITHOUT pulling the cable In this regard it should be noted that the plug must always be free of any material or...

Страница 14: ...42021 BARCO di Bibbiano RE ITALIA Tel 39 0 522 875159 Fax 39 0 522 875579 e mail reverberisrl gmail com Any work on the machine determined by a malfunction must necessarily be performed by qualified...

Страница 15: ...otal weight dry SERENA 18 45kg 441 5N SERENA 23 50kg 490 5N NOTES Check the external condition of the carton box and of the sterilizer In case of damage contact the retailer the shipper and the carrie...

Страница 16: ...SCRIPTION 3 0 KEYBOARD 1 info exit 2 start stop 3 reduction menu 4 increase menu 3 1FRONTAL SIDE 5 Keyboard 6 Switch 7 Sd card 8 Printer connection max 12 VDC 2A 9 Drainage clean water 10 Drainage wat...

Страница 17: ...con stampante 17 99 3 2BACK SIDE 16 Safety valve 17 CE plate 18 Heat exchanger 19 Vent 20 Labeller connection 9 PIN max 12VDC 1A 21 Power cord 22 Clean water tank 23 Water USED tank 24 Connection test...

Страница 18: ...ay shows a message of request for water It is then necessary to connect the supplied tube to the quick connection 14 and press the START button 2 During this phase it is important that the container o...

Страница 19: ...The pump will stop automatically when the tank is full and on the display will appear the screen and then the filling If you notice that during the filling in the tank the water is running out the pum...

Страница 20: ...r refilling the tank with clean water to a minimum The three zeros indicate that no passage of water has been found therefore the quality has not been checked In case of normal water passage numbers i...

Страница 21: ...o empty the water tank clean as follows 1 Set the MANUAL LOADING Menu Settings Manual loading 2 Insert the drain hose red provided in the slot blank Will come out of the water present in the clean wat...

Страница 22: ...Serena Serena con stampante 22 99 3 8 DRAINIG WATER USED EMPTY THE TANK DIRTY WATER Warning The drain water of the sterilizer must be conveyed in a clearly visible labelled container with the words DI...

Страница 23: ...m of the chamber andgently push it until a click warns the connection has been established The support is reversible and can be used for 4 trays or once entered and rotated to 90 for 2 horizontal cass...

Страница 24: ...rature 10 C to 25 C relative humidity 0 90 Storage temperature 3 C to 35 C relative humidity 0 90 The maximum weight of the sterilizer is SERENA 18 45kg 441 5N SERENA 23 50kg 490 5N 4 1 POWER SUPPLY T...

Страница 25: ...p 44 Instruction Manual OPTIONS LABEL PRINTING LAST CYCLE In the case of incorrect printing too high or too low the light is solid green press and hold the button and wait until the light flashes once...

Страница 26: ...rranty period NOTE 4 AND mandatory for the validity of the warranty to keep an SD card inserted To remove the SD card pull it out directly The card supplied has a storage capacity of at least 1 2GB Be...

Страница 27: ...rfectly dry use a paper towel TNT or cloth of low release and without any residual disinfectant since these residues may cause corrosion during the sterilization For the drying of hollow instruments u...

Страница 28: ...eparate envelopes h The instruments of carbon steel should be isolated from the tray with a specific sheet of paper and wrapped with a special double envelope by inserting an indicator of sterilizatio...

Страница 29: ...RILIZER To turn on the autoclave press the main switch 6 on the right side of the sterilizer Only the first time you will turn on the autoclave the display screen appears as below it warns that the st...

Страница 30: ...es 2 Four other temperatures 3 The chamber pressure 4 Quantity of water 5 the voltage 6 Water quality expressed in microns 7 Door status and levels ESC It allows to go to the previous menu or to exit...

Страница 31: ...B Press START to choose the B cycle you want to start UNIVERSAL CYCLE B134 PRIONE CYCLE B134 UNIVERSAL CYCLE B121 Use the arrows to move up and down UNIVERSAL CYCLE B134 PRIONE CYCLE B134 UNIVERSAL CY...

Страница 32: ...recommend keeping on hand a list of the codes of the various operators of the studio We enclose an example in the last pages of this U M M To return to the previous screen press ESC UNIVERSAL B134 OPE...

Страница 33: ...e associated with that patient Another label will be printed for filing If you own a bar code reader you only need to print the labels to be attached to the envelope as they will then proceed through...

Страница 34: ...d uso Serena Serena con stampante 34 99 STEP 1 STEP 2 STEP 3 Date 01 01 00 22 10 01 Time Chamber Temperature 63 8 C 910mbar Chamber Pressure UNIVERSAL B134 Cycle Type START 00 00 NC 0056 20 00 Timer...

Страница 35: ...e B sterilization cycle is suitable for any load solid porous unwrapped and packed in a single envelope or double for hollow type A and B Follow the instructions provided by the manufacturer of the ma...

Страница 36: ...43 MAXp 00 16 32 3164 STRe 00 21 12 135 4 3080 DRYs 00 21 12 135 4 3078 D00 00 22 34 117 9 1096 D01 00 22 55 111 6 493 D02 00 25 36 107 8 901 D03 00 26 22 104 1 498 D04 00 27 37 101 8 901 D05 00 28 24...

Страница 37: ...0000 Nr CYCLE 0000 CYCLE VACUUM TEST OPERATOR CODE 01 DATE 00 00 00 TIME 00 00 00 PHASE TIME T C P mbar VT 0 00 00 16 19 7 992 VT 1 00 03 30 19 6 47 VT 2 00 08 30 20 1 45 VT 3 00 18 30 21 1 45 CYCLE O...

Страница 38: ...HAMBER x x LEAK PERIOD OF AIR x x EMPTY CHAMBER x x SOLID DOUBLE packed LOAD x x SMALL POROUS ITEMS SMALL POROUS DOUBLE packed LOAD x x FULL POROUS DOUBLE packed LOAD x x LOAD CABLE B LOAD CABLE A x x...

Страница 39: ...atically asks filling of clean water Choosing SPECIAL CYCLE Press START to confirm SPECIAL CYCLE1 SPECIAL CYCLE2 If you decide you want to continue with the SPECIAL CYCLE 1 press START SPECIAL 1 OPERA...

Страница 40: ...CIAL 1 TEMPERATURE 134 C Press ESC to exit STERILIZATION TIMER SPECIAL 1 COD OPERATORE 01 PRE VACUUM 2 TEMPERATURE134 TIME STER 05 TIMER 10 Once you press the START button will open the following scre...

Страница 41: ...keys to move down to enter the item below SPECIAL 1 TEMPERATURE134 TIME STER 05 TIMER 10 DRYING N LABELS 01 N LABELS to enter press START SPECIAL 1 N LABELS 01 Once you set the timer press ESC to retu...

Страница 42: ...arrow until the disappearance of the alarm about 20 seconds Then MENU OPTIONS OPEN DOOR and press start twice The door will open automatically The procedure has been studied for safety reasons INTERRU...

Страница 43: ...ess START to access the screen for changing the number of labels then press ESC move down with the arrow and press START Press ESC to exit 6 1 5 2 B D HELIX TEST VACUUM TEST B D HELIX TEST SPORE TEST...

Страница 44: ...t Follow the instructions of the manufacturer of spores to a correct reading of the result VACUUM TEST B D HELIX TEST SPORE TEST OPERATOR CODE NR LABELS ENTER THE TESTS START 7 OPTIONS CYCLES UNIVERSA...

Страница 45: ...ATES 7 1 DRYING ONLY Drying cycle only Pressing the START you will have access to change information DRYING TIMER DRYING 02 START With the arrow move down after selecting the timer drying the drying i...

Страница 46: ...OPTIONS LAST CYCLES DRYING ONLY EXTRA DRYING LABELS EXPIRY DATE 7 3 LABELS EXPIRY DATE Pressing the START you will have access to change information And the expiry date printed on the labels has to be...

Страница 47: ...door in manual mode The display shows the storage temperature of the instruments and the minutes of storage up to 999 minutes OPTIONS LABELS START POSTPONED CYCLE NIGHT CYCLE OPENING DOOR See section...

Страница 48: ...lecting the item press START and press ESC to exit Navigate with the arrow keys to access the item in the SETTINGS menu 8 0 PRE HEATING Press START to access and modify the followings SETTINGS LANGUAG...

Страница 49: ...and DOWN 8 2 DATE FORMAT Press START to access and modify the data SETTINGS LANGUAGE PRE HEATING DRYING TEMPERAT DATE FORMAT DATE TIME The below display will appear DATE FORMAT DD MM YY MM DD YY YY M...

Страница 50: ...ssing START the door will be open and automatically will print the labels If you set the automatic door opening once the sterilization cycle is finished the door opens automatically and the labels are...

Страница 51: ...0990 N CYCLES 0130 0990 INDICATES THE MAXIMUM STERILIZATION CYCLES WITH A WASHER 8 5 3 WATER FILTER Press START to access and modify the data BACTERIAL FILTER WASHER WATER FILTER HAVE THE AUTOCLAVE S...

Страница 52: ...BESERVICED 8 6 TOTAL N OF CYCLES SETTINGS DATE FORMAT DATE TIME OPENING DOOR MAINTENANCE TOTAL N OF CYCLES 8 6 1 VALID CYCLES Press START to access and modify the data VALID CYCLES CYCLES NOT VALID V...

Страница 53: ...VALID VACUUM TEST B D HELIX TEST SPORE TEST The below display will appear VACUUM TEST N OF CYCLES 0201 Press ESC to exit 8 6 4 B D HELIX TEST Press START to access and modify the data VALID CYCLES CYC...

Страница 54: ...E TOTAL N OF CYCLES COUNTERS 8 7 1 WORKING HOURS Press START to access and modify the data WORKING HOURS N OF CYCLES PERFORMED CONFORMABLE WATER LITRES UNCONFORMABLE WATER LITRES The below display wil...

Страница 55: ...RES WORKING HOURS N OF CYCLES PERFORMED CONFORMABLE WATER LITRES UNCONFORMABLE WATER LITRES The below display will appear CONFORMABLE WATER LITRES 0000 Press ESC to exit 8 7 4 UNCONFORMABLE WATER LITR...

Страница 56: ...8 8 CYCLES HISTORY Press START to access and modify the data The historical cycles contains the last ten cycles performed successfully it does not contain cyclesconcluded with alarms 8 9 CONFIGURATIO...

Страница 57: ...n has had a positive exist or if you have to repeat the cycle If the alert occurs during sterilization the display shows UNIVERSAL B134 93 3 C 963 mbar INTERRUPTED CYCLE LOAD NOT STERIL If the alert o...

Страница 58: ...erformance Cable resistance is not connected Resistance burned Electrovalve vaporizer is not working Replace the dispenser Connect the cable properly Check for water leaks Replace the filter Repeat th...

Страница 59: ...ature sensor open Short circuit temperature sensor T1 Short circuit temperature sensor T2 Short circuit pressure sensor Short circuit temperature sensor steamer Short circuit temperature sensor metal...

Страница 60: ...ailure discharge after 2nd thermodynamic Failure discharge after 3rd thermodynamic Failure discharge after 4th thermodynamic Electric valve 5 burned Electric valve 4 burned Check and or replace electr...

Страница 61: ...SOLID TWEEZERS MILLS YES YES YES YES YES EMPTY CHAMBER OR TEST POROUS SMALL OBJECTS SUCH AS GAUZES COTTON YES YES YES NO NO POROUS 80 USABLE SPACE YES YES YES NO NO HOLLOW ITEMS A SUCH AS SCISSORS PLI...

Страница 62: ...ce of these parts of the machine makes optimal the performance of the sterilization cycle In the event of prolonged inactivity switch off the machine leaving the door not completely closed keep it in...

Страница 63: ...bacterial filter manually in a counterclockwise direction Install new filter in a clockwise direction The new bacterial filter should be new and in its original envelope 10 0 2PINS LUBRICATION USER OF...

Страница 64: ...the network cables Only authorized technicians 10 0 6 REPLACEMENT PUMP LOAD AUTHORIZED TECHNICIAN CODE 5154 Remove the casing Empty the tank of clean water Replace the pump and filter making sure to r...

Страница 65: ...the PAKER connector that is attached to the transducer Unscrew the connection of the Teflon pipe Teflon Unscrew the fixing screw of the transducer support Assemble the new transducer that will be feat...

Страница 66: ...he electronic card Check that the new display work correctly If everything is ok proceed to remove the old display and replace with the new display 10 0 13 REPLACEMENT PIN DOOR AUTHORIZED TECHINICIAN...

Страница 67: ...ll the lever until the Cover Group is released from its locking position To avoid damages to the lever do not use excessive force How to load paper rolls Step 1 Step 2 How to close the Cover Group cor...

Страница 68: ...3 07 17 00 Per Bertani Manuali d uso Serena Serena con stampante 68 99 How to cut the paper correctly Pull the paper towards the Tear Bar from one side to the other Use only original rolls and place t...

Страница 69: ...y 500 hours Every 1000 hours Every 6 month s Every 2000 hours Every 2 years Every N cycles Electrical safety test Visual inspection any subsidence of isolation burns 2000 or 2 years Check continuity o...

Страница 70: ...l Maintenance Cleaning water filter 2000 or 2 years Clean door gasket General cleaning of exterior and interior surfaces Cleaning the sterilization chamber Cleaning support for trays and cleaning tray...

Страница 71: ...oading Valve purifier 2000 or 2 years 2 Guarantee slip with replacement and or control of Membrane gaskets of vacuum pump Group Vaporizer Drain valve 3 way valve Control door lock Control ACTUATORS Cl...

Страница 72: ...l Filter 1 1067 3 Power Cable 1 4404 4 Pressure Transducer 1 5125 5 Probe Double T1 T2 1 5123 6 SD Card 1 4490 7 Label Roll 1 K800262 8 Float Tank Range 1 3907 9 Water Filter 1 1484 10 Bowie Dick Test...

Страница 73: ...elation of the user or users risk factors Features and requirements of fire equipment specified in this U M M are minimal and are not binding and do not release the buyer in the country of use from an...

Страница 74: ...ls not properly wrapped Dry thoroughly the tools before the sterilization Rinse carefully the tools Clean tools carefully Place on several trays the tools of different material Always keep the chamber...

Страница 75: ...inside the chamber will already have been eliminated VOLUNTARY INTERRUPTION during the SPECIALcycle1 1 Acoustic signal with a message on the display showing ALARM CYCLE INTERRUPTED PLEASE WAIT 2 See...

Страница 76: ...3500 absolute Bar mBar Max temperature 140 140 C Safety valve 2 5 3500 absolute 2 5 3500 absolute Bar mBar Bacteriological filter 0 027 0 027 m Temperature Operating humidity Da 5 a 29 C 0 90 Da 5 a...

Страница 77: ...NDIXES 14 0 HYDRAULIC DIAGRAM 4 A 1st VACUUM ON 6 3 5 30 B STEAM ON 1 8 3 C STEAM DISCHARGE ON 6 4 UP TO 1100 mbar C 1STEAM DISCHARGE 2 D STERILIZER ON 10 5 E HOT WATER DISCHARGE ON 5 4 UP TO 1100 mba...

Страница 78: ...SERENA P GB R04 del 03 07 17 00 Per Bertani Manuali d uso Serena Serena con stampante 78 99 14 1 ELECTRICAL...

Страница 79: ...on LOCK 8 With the sterilizer OFF insert the SD card 9 Turn on the sterilizer making sure to press the power button once Wait for the acoustic signals end up bip bip bip pause bip bip bip and the disp...

Страница 80: ...e autoclave To copy a new software or for updates to the same after formatting using copy paste and copy on a removable disk E Warning When you insert a new software or for updates and the SD card is...

Страница 81: ...ni Manuali d uso Serena Serena con stampante 81 99 14 2 LABELLING The following is an example accompanied by brief description of the labelling that you will find on the device 14 3 EXPLODED VACUUM PU...

Страница 82: ...ark You should keep STORED all test results in a register TEST HELIX It is THE SPECIFIC TEST FOR MEASURING THE EFFICIENCY OF STERILIZATION FOR LOADS OF HOLLOW OBJECTS OF TYPE A TIME OF THE TEST Steril...

Страница 83: ...eters time temperature and humidity 1 on temperature 15 on time Normal sterilization cycle 6 Helix test Measures three parameters 1 on temperature 5 on time Dedicated test cycle Spore Test The spores...

Страница 84: ...e 00 19 15 136 7 3180 DRYs 00 19 15 136 7 3181 D00 00 20 47 121 3 1099 D01 00 21 09 115 5 498 D02 00 23 45 111 4 901 DRYe 00 24 15 109 0 609 CYCLE OK SERENA 23 ONLY B CYCLE Ver 027 S N 000000 Nr CYCLE...

Страница 85: ...the daily maintenance are run such as Cleaning the door Cleaning of the chamber trays and port trays Check that the water used is distilled clear and not recycled Check the quality of the water with t...

Страница 86: ...harge electro valve 1 3246 3 ways electro valve 1 3028 Purifier electro valve 1 5158 Door micro switch 1 5040 Door pin Registration and control door pressure Replacement water filter Cleaning tanks Lu...

Страница 87: ...d mail to our address or fax number 0039 0 522 875579 Thank you COUPON WITHIN 2000 CYCLES OR TWO YEARS Date Serial Number Model of autoclave At the studio of Address Post Code City STAMP AND SIGNATURE...

Страница 88: ...switch 1 5040 Door pin Registration and control door pressure Replacement water filter Cleaning tanks Lubrication door plug Control actuators Control temperature parameters pressure and test cycles Co...

Страница 89: ...lete and mail to our address or fax number 0039 0522 875579 Thank you COUPON WITHIN 4000 CYCLES Date Serial Number Model of autoclave At the studio of Address Post Code City STAMP AND SIGNATURE OF THE...

Страница 90: ...ro valve 1 3028 Bypass electro valve 1 5123 Temperature sensors T1 and T2 1 5244 Discharge pipes 1 5279 Batteries electronic card mod CR2032 1 5040 Door pin Registration and control door pressure Repl...

Страница 91: ...ete and mail to our address or fax number 0039 0 522 875579 Thank you COUPON WITHIN 6000 CYCLES Date Serial Number Model of autoclave At the studio of Address Post Code City STAMP AND SIGNATURE OF THE...

Страница 92: ...keep them 4 Send back the autoclave packed in the original packaging in which it was purchased In absence of the original packing please pack the machine in a suitable packing on pallet for handling w...

Страница 93: ...shment of spare parts or parts that prove defective manufacturing excluding expenses or call Any particular replaced must be returned prepaid Any piece that is not returned will be billed to the payer...

Страница 94: ...00 Per Bertani Manuali d uso Serena Serena con stampante 94 99 14 8 VARIOUS FORMS Codes operators table STUDIO DOC INT NR Responsibleof the Studio Doct Operator Code Operator name Date of assignment 0...

Страница 95: ...TION STERILIZATION CYCLES At the end of each sterilization cycle the form must be filled in attacking the chemical indicator used in the Helix test to the specific column The success of the sterilizat...

Страница 96: ...S THAT CAN PERFORM THE FUNCTION SIGNATURE START OF THE OPERATIVE CYCLE OPERATOR SELECTION OF THE OPERATIVE CYCLE OPERATOR SUPERVISOR MODIFICATION OF THE PARAMETERS OF THE OPERATION CYCLE OPERATOR SUPE...

Страница 97: ...e user on the functioning of the machine with the support of the instruction manual and he declares to have explained the timing of scheduled and daily maintenance See paragraph 11 MAINTENANCE Instruc...

Страница 98: ...SERENA P GB R04 del 03 07 17 00 Per Bertani Manuali d uso Serena Serena con stampante 98 99...

Страница 99: ...tructed the user on the functioning of the machine with the support of the instruction manual and he declares to have explained the timing of scheduled and daily maintenance See paragraph 11 MAINTENAN...

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