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User Manual

Summary of Contents for 30006590

Page 2: ...TECHNICAL ASSISTANCE Vircell S L Parque Tecnol gico de la Salud Avicena 8 18016 Granada Spain Tel 34 958 441 264 Ext 149 E mail customerservice vircell com The information contained in this manual is...

Page 3: ...s all the information needed to use the instrument and keep it ready to operate Before the use of the instrument therefore the user must read carefully this user manual Also please read the package in...

Page 4: ...ON PROGRAMMING RUNNING AND RESULTS 25 3 3 1 WASH BUFFER CLEANING SOLUTION AND WASTE TANK 25 3 3 1 1 FILL THE WASH BUFFET TANK 5L CAPACITY 25 3 3 1 2 FILL THE DISTILLED WATER TANK 0 25L CAPACITY 26 3 3...

Page 5: ...2 WASH BUFFER EMPTY 43 4 3 WASTE TANK HIGH LEVEL 43 4 4 STRIP WASTE CONTAINER FULL 44 4 5 MOTOR OR HARDWARE ERROR 45 5 MAINTENANCE 46 5 1 GENERAL RULES 47 5 2 RESPONSIBILITIES 47 5 3 DAILY MAINTENANC...

Page 6: ...Operator s Manual Operating Procedure 6 50 1 INTRODUCTION 1 1 PREFACE 7 1 2 SYMBOLS 7 1 3 INTENDED USE 8 1 4 GENERAL DESCRIPTION 8 1 5 TECHNICAL SPECIFICATIONS 11...

Page 7: ...pies of the present Manual 1 2 SYMBOLS Legend of graphic symbols used on the Instrument Instrument satisfying requirements of European directive on in vitro diagnostic medical devices 98 79 EC In vitr...

Page 8: ...esce assays Therefore it is not allowed to perform tests with VirClia Lotus if reagents are not provided or authorized by Vircell Users are not allowed to make changes neither to the instrument nor to...

Page 9: ...oor Closed Figure 1 4 02 Front View Lids Open Legend 1 Sample Rotor Wash Buffer Container 2 Sample Needle Arm 7 Distilled Water tank 3 Strip Rotor 8 Additional Reagents Rack 4 Sample Needle Washing We...

Page 10: ...ter used during the maintenance is stored in this tank The capacity is 0 25 liters The instrument contains a balance to weight the DI water 8 Additional reagents racks Rack used for additional reagent...

Page 11: ...ED CPU BOARD STM32F4 PROCESSOR WITH 8MB SDRAM 1MB FLASH 1KB EEPROM MICRO SD CARD FOR INTERNAL FILE STORAGE PERIPHERAL CONTROL UNITS MICROPROCESSOR BOARD ON HOST BUS INTERFACE 1 USB CLIENT FOR HOST COM...

Page 12: ...ble with power supply network of the installation country The analyzer contains nr 1 battery Li Mh CR2032 on the CPU board MINIMUM REQUIREMENTS OF THE WORKSTATION COMPUTER INTEL CORE I3 2 8 GHZ PROCES...

Page 13: ...ERSION NO INTERVENTION DELAY MINIMUM BATTERY CAPACITY 14 AH OUTPUT CHARACTERISTICS VOLTAGE DISTORTION WITH NON LINEAR LOAD WAVEFORM CURRENT CREST FACTOR 4 SINUSOIDAL 3 1 INTERFACE SERIAL OR USB PORT A...

Page 14: ...Manual Operating Procedure 14 50 2 INSTALLATION 2 1 TASKS OF THE TECHNICAL ASSISTANCE NECESSARY EQUIPMENT 15 2 2 PRELIMINARY CHECK 16 2 3 PLACEMENT 16 2 4 CONNECTION 17 2 5 SOFTWARE DESIGN AND SPECIFI...

Page 15: ...THIS DOCUMENT RELEASE THE MANUFACTURER FROM ALL LIABILITY AND MAY CAUSE INSTRUMENT DAMAGE NECESSARY EQUIPMENT INSTRUMENTATION TOOLS REQUIRED FOR MAINTENANCE Digital multimeter Harta STRIPT Temperatur...

Page 16: ...o connect the cables only with external devices power switch in off position Verify the continuity of the ground in the electrical system IT IS ABSOLUTELY FORBIDDEN to remove or modify or override any...

Page 17: ...he dust 2 4 CONNECTION To connect the mains supply cable 1 Verify the OFF position of the main switch 2 Connect the main power supply cable in the mains inlet located on the right side of the instrume...

Page 18: ...classification of the software on the basis of its critical nature and potential impact on the patient s health clinical status The class for the overall system software is Class B non serious injury...

Page 19: ...BUFFET TANK 5L CAPACITY 25 3 3 1 2 FILL THE DISTILLED WATER TANK 0 25L CAPACITY 26 3 3 1 3 EMPTY THE WASTE TANK 26 3 3 1 4 EMPTY THE STRIP WASTE CONTAINER 27 3 3 2 HOME SCREEN 27 3 3 3 RUNNING SCREEN...

Page 20: ...t transport or move the equipment since it contains fragile material It is not allowed to override the safety and protection devices of the access door micro switch and electromag netic sealing of Vir...

Page 21: ...e will be carried out with the equipment disconnected and having allowed the temperature zones to cool down This manual includes the importance of proper maintenance stated in section 5 maintenance In...

Page 22: ...e Corrosive substances that may cause burns and damage to eyes Always be aware of the risks that these substances may pose Avoid exposure to corrosive substances Use protective clothing safety goggles...

Page 23: ...urrent safety regulations of the country where it is installed Environmental Requirements Install VirClia Lotus on a level surface in a place where a constant temperature and a proper level of humidit...

Page 24: ...volume of sample is the dead volume plus the sample volume necessary to run the assay Tubes pre programed in the VirClia LOTUS software are as stated below 75mm x 11mm 100mm x 11mm 75mm x 12mm 100mm...

Page 25: ...rd and video o Make sure the used strips case is empty o Make sure the waste tank is empty o Make sure the drainpipe is placed into the specific tank or into the centralized drain if available 3 3 SES...

Page 26: ...5L CAPACITY Fill the distilled water tank and connect the tubing 3 3 1 3 EMPTY THE WASTE TANK Take the Tubing with Self Clutching joint Connect to the Left Side connector Then press Open Waste located...

Page 27: ...1 4 EMPTY THE STRIP WASTE CONTAINER Then put it back in its position Make sure that the orientation of the waste container is correct please see below 3 3 2 HOME SCREEN Once started the Lotus Applica...

Page 28: ...and position of all the Strip Holders and find the empty position The hydraulics priming to properly fill all the tubing dilutors pumps and needles By pressing Start Working VirClia Lotus will perfor...

Page 29: ...0 if the empty position is in the reaction rotor Next Loading Phase in time needed to be waited before to be able to load other Samples and or Strips at start up it is now In the Bottom Bar of the pro...

Page 30: ...an manually edit the codes of the unread labels The empty positions are shown as empty white rows they are positively identified since the samples rotor brings a background barcode label that if read...

Page 31: ...ink each sample to one or more assays that has to be performed with it In this case there are two possible ways to perform this step Manually by clicking on the boxes the user will create the link bet...

Page 32: ...assigned with their respective assays test the program elaborate the shopping List a list of all the Monotest devices needed to execute the analysis session grouped per test type In this way the user...

Page 33: ...nual Operating Procedure 33 50 Decontaminant bottle and additional reagents bottles should be placed onto the Linear Rack on the right side in or der to be scanned Press Continue to proceed Load Resou...

Page 34: ...Screens appears The software guides the user in loading the Monotest Devices Strips Each type of Monotest device is represented with a different color the color assignment is shown in a table located...

Page 35: ...e the strip loading rotor will move to the next 10 free positions In the following images you can see the example of a four stages strip loading procedure with a total of four load strips screens Once...

Page 36: ...e of each strip the software can detect if the strip is expired or if it is the wrong strip At the end of the scanning cycle if any of the above error conditions is present it is signaled and the user...

Page 37: ...will show green 3 3 10 RUNNING SCREEN By clicking OK the program will start the analysis cycle and the running screen will appear showing the current position of the samples and strips By clicking on...

Page 38: ...mples or Urgent Sample the instrument will so receive a request to access to the sample s rotor and to the strip rotor The instrument s CPU will complete any action it is performing on one strip and t...

Page 39: ...results are transferred to the host computer of the laboratory Finally if a printer has been connected to the PC and configured in the service menu the results will also be printed out 3 3 13 END OF W...

Page 40: ...RNING MESSAGES 4 1 SAMPLE OR REAGENT LIQUID LEVEL DETECTION FAILURE 41 4 2 WASH BUFFER LOW VOLUME 42 4 2 1 BEFORE USING THE INSTRUMENT 42 4 2 2 WASH BUFFER EMPTY 43 4 3 WASTE TANK HIGH LEVEL 43 4 5 ST...

Page 41: ...ts bottles If before aspirating from one of the containers the liquid level is not detected the following message box is displayed The user is requested to perform one of the following actions Retry R...

Page 42: ...onitored When the liquid is below the total volume that the software estimates that is needed to perform the assay a warning message is displayed The user is requested to perform the following actions...

Page 43: ...refill to allow the system to restart working Attention in case the refill is delayed too much some of the tests could be aborted 4 3 WASTE TANK HIGH LEVEL The waste tank volume is continuously monito...

Page 44: ...y is calculated after each strip disposal when the number of discarded strips exceed the maximum the system stops discarding the other Strips that will remain on the reaction rotor until the container...

Page 45: ...RROR All the movements and hydraulics activity are continuously monitored If any failure occurs during the exam process an alert window will be displayed and the user may be requested to perform some...

Page 46: ...Manual Maintenance 46 50 5 MAINTENANCE 5 MAINTENANCE 46 5 1 GENERAL RULES 47 5 2 RESPONSIBILITIES 47 5 3 DAILY MAINTENANCE PROCEDURE 47 5 4 WEEKLY MAINTENANCE PROCEDURE 488 5 5 MONTHLY MAINTENANCE PR...

Page 47: ...y the Technical Service 5 3 DAILY MAINTENANCE PROCEDURE Daily maintenance includes startup and shutdown steps Startup steps are performed prior to the first run of the day and shutdown steps are perfo...

Page 48: ...the strip waste container inside the container there are rests of samples and therefore there can be contact with biohazardous materials Using gloves empty the container and clean the inner part usin...

Page 49: ...of the tank Do not shake vigorously to avoid creating too much foam Leave the solution acting inside for 5 10 minutes and then rinse the tank with water thoroughly Clean the working area with a humid...

Page 50: ...of the rotor To be able to correctly reattach the sample rotor the 2 pins have to fit in the 2 holes o Once the rotor has fit screw the rotor bolt Note if the wash tank has not been disinfected weekl...

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