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1. Medical Devices CE0681 OD The marking reflects compliance with the Council Directive 1999 5 EC on radio equipment and telecommunications terminal equipment Symbol for SERIAL NUMBER according to the European Standard EN 980 Disposal of Electrical and Electronic Equipment In the European Union electrical and electronic equipment must notbe disposed of with other household type waste It must be collectedseparately Please observe the relevant legal regulations effective in Your Country Symbol for the MANUFACTURER EN980 Stds Symbol for CATALOGUE NUMBER according to the European Standard EN 980 User Manual Revision 1 15 Page 7 of 73 CONTENTS 1 INTRODUCTION 10 tbl Intended Destinato eieaa a R aa 10 l 2 Kevineature Seina a aa 10 2 INSTALLATION 11 21 Unpacking ATCRIMEA E aeoeaii ra 11 2 2 POSIUONING ArCHIMCGE rrise eiia na aa a a 11 2 3 Assembling weight scale filter holders and antenna 12 2 4 SWitching Oh ArehniimeCd ccssdarssatesavenstaeceiashahaommiaahetenemianiahcademaaae 12 25 lt INSTTUMEnNESEeU aria 14 2 5 1 Date and Time 14 2 5 2 Procedures Setup Check 14 3 GENERAL DESCRIPTION 15 Silk UPPE aie sana EOAR 15 3 2 FFONE PaNelaarharnilli aiclccaiaret 16 Bs Lateral Panelis ai 16 3 Rear Pane lesie aa a a A A A EE 17 Saa Key 20 al A Ea a aA A A A a 18 320 BaACKiOGMU DISDIAY flare 19 3 6 1 Main Menu 19 3 6 2 Enable procedure list 19 3 6 3 Utility menu
2. 2 the message Break cannulas will be displayed Break the cannulas by forcing on their side upper part and wait a few seconds for pressure reduction After detecting pressure decrease Archimede automatically starts the separation cycle If due to obstructions or tube kinks pressure circuit is n duced below the threshold set it is any way possible to force the cycle start by pressing key button If the cannula breaking is not active 2 Archimede automatically starts the cycle of separation The graphic interface will now show the current operating phase number and the weight value of PLT collected Archimede will check the flow and stop the plate in case of filter obstruction or RBC presence in the HB sensor In case of filter obstruction the operator can press START and continue until the a warning while in case of RBC presence if parameter 19 is set the system will asked if you want to end the procedure or continue in manual mode Air removal depends on procedure parameters setting 42 Manual air removal put plasma bag in vertical position press START key button to open clamp 3 and remove air manually by pressing on the bag When finished press oso key button to close clamp 3 and re position plasma bag to detect weight The process will continue automatically Now remove tubes and bags and press START to continue with another separation of the same type or press to exit Page 50 of 73 User Manual Version 1 15 USI
3. IP41 Protection against objects gt 1 0 mm diameter touching internal parts Vertically falling water will not have any harmful effect The marking reflects compliance with the Council Directive 93 42 EEC on C Medical Devices The marking reflects compliance with the Council Directive 1999 5 EC on radio equipment and telecommunications terminal equipment Symbol for SERIAL NUMBER according to the European Standard EN 980 Symbol for CAUTION CONSULT ACCOMPANYING DOCUMENTS according to the European Standard EN980 Bar code reader Disposal of Electrical and Electronic Equipment In the European Union electrical and electronic equipment must notbe disposed of with other household type waste It must be collectedseparately Please observe the relevant legal regulations effective in Your Country Symbol for the MANUFACTURER EN980 Stds Symbol for CATALOGUE NUMBER according to the European Standard EN 980 User Manual Revision 1 15 Page 5 of 73 MARKI NGS List of the symbols and marks used on the device Class I Equipment in which protection against electrical shock does not rely on basic insulation only but which includes an additional safety precaution in the form of a means for the connection of the equipment to the protective earth conductor in the fixed wiring of the installation in such a way that accessible metal parts cannot become live in the event of a failure of the basic insulation EN
4. User Manual Version 1 15 Page 57 of 73 Error 3 Error 4 Error 5 Error 6 Error 7 Error 8 Error 9 Error 10 1 4 Error 11 1 4 Error 12 1 4 Page 58 of 73 TROUBLESHOOTI NG Remedy Turn Archimede OFF and ON Cause 2 Defective microcontroller E prom memory Remedy Call Authorized Service Center SPI TIMEOUT Cause 1 One peripheral unit has unexpectedly interrupted the communication Remedy Turn the instrument OFF and ON Cause 2 Defective CPU or SO board Remedy Call Authorized Service Center RFID TIMEOUT Cause 1 Defective RFID label Remedy Replace RFID label Cause 2 RFID module is not responding Remedy Turn the instrument OFF and ON RFID COMUNI CATI ON ERROR Cause 1 RFID data are corrupted Remedy Turn the instrument OFF and ON CORRUPTED BOOT LOADER Cause 1 Checksum of boot loader routine is not correct Remedy Call Authorized Service Center CORRUPTED FIRMWARE Cause 1 Checksum of firmware is not correct Remedy Download firmware by ALNK WRONG CALI BRATI ON DATE Cause 1 Data loss or corrupted Remedy Run scales calibration PARAMETER OVER RANGE Cause 1 During parameter check an error in parameter value has been detected Remedy Run procedure update AD CONVERTER IS IN OVERFLOW Cause 1 Incorrect analog power Remedy Check that scales holders are correctly mounted and free from obstructions Turn Archimede OFF and ON AD CONVERTER TI MEOUT Caus
5. Kit installation procedure umbilical cord Kit installation aliquot separation procedure Kit installation procedure PLT BC Kit installation procedure T amp T with predefined HCT Calibration menu Calibration sample weight setting First step calibration Second step calibration Calibration factors display LAN connection WLAN connection Page 9 of 73 INTRODUCTION 1 INTRODUCTION The present operator manual describes functions operation and using instructions of Archimede Please read the present document before using the instrument and keep it to hand for consultation in order to ensure proper system operation Archimede is an automatic extractor of blood components from whole blood It allows to separate Erythrocytes Buffy Coat and Platelets from rich and poor plasma and platelet concentrate Both Standard and Top amp Bottom bags can be used and thanks to the high automatization one single operator can use several units at the same time The laboratory productivity is therefore increased maintaining a high and standardized separation quality The separation procedure is continuously checked by a dedicated microcontroller In case of alarm or if the preset parameter values are reached the procedure is stopped 1 1 Intended Destination Archimede should be used by Qualified Personnel only It has been designed for the separation of blood components contained in hermetically sealed bags bags containing whole blood and o
6. 4 6 Use as manual separator Archimede can also be used as a manually controlled separator In this mode the enabled checks are the following e Position sensor determining the plate standby position e Force sensor determining plate stop if the applied force exceeds the set value When the applied force decreases below the value calculated according to the hysteresis the plate starts again The values set for force and hysteresis are those set during the first active procedure ATTENTION THE FORCE SENSOR IS ENABLED ONLY WHEN THE PLATE MOVES TOWARDS THE INSTRUMENT BODY CAUTION DO NOT PUT YOUR HANDS IN THE PLATE WORKING AREA WHEN THE PLATE IS MOVING a To enter this mode use the arrows SF to highlight the icon Rel and then press Now press the arrows up or down to move the plate in the desired direction and press the arrows left or right to change the applied force with fix increments of 5 units To stop the plate and maintain the position press stor to exit and move the plate to Standby position press In this mode you can also enable the clamps by pressing 4 key button and seal by pressing key button Clamp 5 of Red Cell Additive Solution is not provided with sealing head and cannot be used as a sealer Page 26 of 73 User Manual Version 1 15 USING ARCHIMEDE 5 Separation Procedures Archimede can store up to 18 procedures The operator can perform a manual selection or an automatic selection if the system i
7. 60601 1 Regulations IP41 Protection against objects gt 1 0 mm diameter touching internal parts Vertically falling water will not have any harmful effect The marking reflects compliance with the Council Directive 93 42 EEC on C Medical Devices The marking reflects compliance with the Council Directive 1999 5 EC on radio equipment and telecommunications terminal equipment Symbol for SERIAL NUMBER according to the European Standard EN 980 Symbol for CAUTION CONSULT ACCOMPANYING DOCUMENTS according to the European Standard EN980 Bar code reader Disposal of Electrical and Electronic Equipment In the European Union electrical and electronic equipment must notbe disposed of with other household type waste It must be collectedseparately Please observe the relevant legal regulations effective in Your Country Symbol for the MANUFACTURER EN980 Stds Ensure that hand s and or finger s are not between or too close to the plates during compression Symbol for CATALOGUE NUMBER according to the European Standard EN 980 Page 6 of 73 User Manual Version 1 15 MARKINGS List of the symbols and marks used on the carton box LN t Symbol used to indicate that the product should be kept dry Symbol for temperature limitation The upper and lower temperature 70 C limits will be indicated on either side of the symbol The marking reflects compliance with the Council Directive 93 42 EEC on C
8. Cause 1 The plate is in position where weight measured must be less Remedy Verify any obstructions that may create false weight readings Check bag setting parameters TIMEOUT PLATE Cause 1 The distance detected did not change over the last 18 seconds Remedy Verify any obstructions of the tubes and proper breaking of cannula HIGH SENSOR TUBE LIGHT Cause 1 Ambient light detected by the sensor tube x is too high Remedy Reduce ambient light Change tube sensor x NOT IN USE NOT IN USE TIMEOUT CANNULA BREAKER MOTOR Cause 1 Mechanical obstructions prevent CB movement Remedy Remove any obstruction Cause 2 CBposition sensor defective Remedy Call Authorized Service Center User Manual Version 1 15 MAI NTENANCE 9 Maintenance Archimede requires very little maintenance It simply consists in keeping clean case clamps flow valve optical sensors and the weighing system calibration control 9 1 Daily Maintenance 9 1 1Cleaning Clean upper weight scales tray and holder with detergent or disinfectant avoid hitting the mechanical device supporting the tray and do not pour liquids inside the central gap Clean clamps hollow and its actuator with a wet cotton wad Clean Archimedecase with disinfectant Keyboard and optical sensors should be cleaned only with a cloth dampened with water Warning Never use alcohol acetone trichloroethylene or any solvents 9 1 2Decontamination Remove the upper w
9. Cause 2 Fuse blown Remedy Replace burnt fuses with new ones of the type reported on data plate Error 2A DATE AND TIME LOSS Cause 1 Reset of RTC circuit due to big conducted interferences Remedy Re set date and time Cause 2 Archimede has been switch off for a long period Remedy Leave Archimede on for some hours Cause 2 RTC backup capacitor is exhausted Remedy Call Authorized Service Center Error 3A THE DISPLAY SHOWS INCOMPREHENSI BLE CHARACTERS Cause 1 Electronics interferences Remedy Press ESC Turn Archimede OFF and ON Call Authorized Service Center Error 4A ARCHI MEDE DOES NOT CONNECT TO ARCHI MEDELI NK Cause 1 ArchimedeLI NK is not enabled or Archimede network is disconnected Remedy Enable ArchimedeLI NK server Connect to Archimede WLAN network Check that Archimede and ArchimedeLINK server subnets are correct Check firewall settings Cause 2 Noisy communication Remedy Check signal strength and ensure that Archimede s antenna is correctly screwed on and is not near metal objects Bring access point or server closerArchimede units Change the WLAN module transmission channel Call Authorized Service Center 8 2 Errors with Archimede codes Error 1 E PROM BUSY Cause 1 E prom memory stuck or defective Remedy Turn Archimede OFF and ON Cause 2 Defective microcontroller E7prom memory Remedy Call Authorized Service Center Error 2 E PROM VERIFY Cause 1 E PROM verify failed
10. Sil 9 1 9 1 1 Cleaning 2 Decontamination 3 Monthly Maintenance 9 2 Yearly Maintenance sreci a a a a een a 9 3 Maintenance Recordati 10 ACCESSORIES 11 12 DISPOSAL 11 1 Packing Material Disposal rr il 2 Archimede DiSp Salisisiotirii nnar aa a aita ELECTROMAGNETIC COMPATIBILITY 13 TECHNICAL FEATURES 14 ARCHIMEDE APPLICABLE STANDARD REGULATION LIST AND CERT Picture 1 Picture 2 Picture 3 Picture 4 Picture 5 Picture 6 Picture 7 Picture 8 Picture 9 Picture 10 Picture 11 Picture 12 Picture 13 Picture 14 Picture 15 Picture 16 Picture 17 Picture 18 Picture 19 Picture 20 Picture 21 Picture 22 Picture 23 Picture 24 Picture 25 Picture 26 Picture 27 Picture 28 Picture 29 Picture 30 Picture 31 Picture 32 User Manual Version 1 15 IFICATIONS PI CTURES Parts included in the packing Archimede display Screen shot Self Test Date and time format list Global view Lateral Panel Keyboard Enable procedures list Utility menu Date and time format list Screen shot Self Test in progress Reading weight scales area Archimede view Enable procedures list Kit installation procedure T T triple Kit installation T T quadruple procedure Kit installation T B triple procedure Kit installation T B quadruple procedure Kit installation procedure PRP to PPP PLT Kit installation procedure PLT with filter Kit installation procedure erythrocytes washing
11. Valve actuator movement is locked Remedy Remove tubes or any obstruction from the actuator and retry Check if cable is inserted correctly Replace flow valve assy Cause 2 Defective position sensor Remedy Call Authorized Service Center STEP NUMBER UNSUITABLE FOR COMPLETING ONE FLOW VALVE CYCLE Cause 1 Valve actuator movement is locked Remedy Remove tubes or any obstruction from the actuator and retry Check if cable is inserted correctly Replace flow valve assy Cause 2 Defective motor Remedy Call Authorized Service Center User Manual Version 1 15 Page 61 of 73 Error 36 Error 37 Error 38 Error 39 Error 40 Error 41 Error 42 Page 62 of 73 TROUBLESHOOTI NG Error 35 1 3 CELL K OVER RANGE Cause 1 Remedy In self test phase during calibration factors check an error has been detected Recalibrate all scales FORCE SENSOR K OVER RANGE Cause 1 Remedy In self test phase during calibration factor check an error has been detected Recalibrate force sensor INSUFFICIENT PLASMA PLT Cause 1 Remedy Cause 2 Remedy The plasma amount set in the procedure is higher than the amount collected Verify actual value Scales not calibrated Calibrate scale INSUFFICIENT PLASMA WEIGHT Cause 1 Remedy During separation plasma weight is not adequate Check that the cannula has broken and that there are no obstructions then go on I NSUFFI CIE
12. and get synchronized to ArchimedeLINK When using the instrument for the first time date and time need to be checked only if the system is not integrated with ArchimedeLI NK 2 5 1Date and Time Vo Using direction key buttons w highlight the display area indicating current date and time Press ss to enter edit mode or directly with the key Pover the K lt gt ha time Set date and time using keys up and down key to increase or decrease value left and right to change the digit to modify and to confirm setting If you don t want to confirm the date and time change press key FORMAT READING 0 12 am pm dd mm yyyy 01 04 2008 mm dd yyyy 04 01 2008 yyyy mm dd 2008 04 01 Picture 4 Date and time format list 2 5 2Procedures Setup Check This check allows to verify all procedure parameters and should be performed by the application specialist or service engineering Procedure parameters and their meaning are described and can be set through ArchimedeLINK The procedure is continuously displayed to enable users above all those working in stand alone mode to verify its correctness To enter Laz KD this menu press 9 key button above the icons and use direction key button gt to select PARAMETER LIST Confirm setting with key e Using direction key buttons it is possible to select the desired procedures Archimede due to its versatility enables automation combined with ease of use It s setup with a minimum of
13. back to the procedures list page press button Incorrect weights press one of the 6 key buttons below the display to weigh blood components again To accept the new values and send them to ArchimedeLI NK press Archimede will automatically send to ArchimedeLINK all events and data of the procedure performed Now remove tubes and bags and press START to continue with another separation of the same type ore press to exit Page 48 of 73 User Manual Version 1 15 USING ARCHIMEDE 5 3 10 PROCEDURE 12 c PLT BC from single Buffy Coat This procedure allow to use double bags for the collection of platelets from single or pools of Buffy Coat with filter for platelets PLT and Buffy Coat residue Res Separation Description Clamp 1 a Picture 24 Kit installation procedure PLT BC RI x Position bags and tubes according to the below sequence Be sure to avoid tensions and kinks that might cause flow obstruction or weighing errors Hang the primary bag on the bag holders of the front panel The label containing bag data should always be turned outside After detecting the primary bag the plate will move backward to make positioning of Red Cell Additive Solution bag easier and the display will show the bag icon Open cover of HB sensor and insert the tube coming from filter into the reading area Close the cover Insert the tube coming from the HB sensor firmly into clamp 1 Position the PLT bag on upp
14. cord Position bags and tubes according to the below sequence Be sure to avoid tensions and kinks that might cause flow obstruction or weighing errors Hang the primary bag on the bag holders of the front panel The label containing bag data should always be turned outside After detecting the primary bag the plate will move backward to make positioning of Red Cell Additive Solution bag easier and the display will show the bag icon Open cover of HB sensor and insert the tube coming from the primary bag into the reading area Close the cover Insert the tube coming from HB sensor into clamp 6 Insert the tube coming from clamp 6 into clamp 3 Position the plasma bag on upper weight scale Insert bottom tube into clamp 4 Position the RBC bag on lateral weight scale Archimede checks correct tubes positioning inside proper clamps by means of its optical sensors The tube is correctly inserted when the clamp number is replaced by the icon Tony with tube control enable When all the bags and tubes are in position the text at the top right will be changed to START and the procedure start automatically Press START key button to start the procedure if the autostart doesn t happen If the primary bag expected weight check has been enabled through ArchimedeLINK and the measured weight does not fall within the defined limits a warning will be displayed showing both limits and current weight After verifying the cause of the proble
15. is greatest near the source of a transmitting antenna portable and mobile RF communications equipment can affect medical electrical equipment Archimede has been designed to withstand the effects of EMI electromagnetic interference and meets the most current EMC standards that apply to the instrument However extremely high levels of electromagnetic energy above the levels of IEC 60601 1 2 may still produce interference To reduce the risk of EMI follow these recommendations Do not turn on or use hand held personal communications devices such as mobile two way radios or cellular phones near the instrument If these devices need to be used follow the recommended separation distance as shown in the following tables In the case of unexplained EMI consider the locations of nearby transmitters such as radio or TV stations You may have to move the instrument or place shield material between the transmitter and the instrument Be aware that modifying the instrument or adding accessories or components not specifically authorized by MOELA may make the instrument more susceptible to interference from radio waves Table 1 Guidanceandmanufacturer sdeclaration electromagneticemissions TheModelArchimedeisintendedforuseintheelectromagneticenvironment specifiedbelow Thecustomer orthe useroftheModelArchimedeshould assurethatitisusedinsuchanenvironment Compliance Electromagneticenvironment guidance ne TheModelArchimede
16. put lines 1kVdifferenti al mode 2kVcommonmode lt 5 UT gt 95 dipinUT for0 5cycle 40 UT 60 dipinUT for5cycles 70 UT 30 dipinUT for25cycles lt 5 UT gt 95 dipinUT NOT applicable the apparatus does not contain any device susceptible to power frequency magnetic fields Electromagneticenvironmen t guidance Floorsshouldbewood concreteor ceramictile Iffloorsarecoveredwithsy ntheticmaterial therelativehumidity shouldbeatleast30 Mainspowerqualityshouldbethatofa typicalcommercial orhospital environment Mainspowerqualityshouldbethatofa typicalcommercial orhospital environment Mainspowerqualityshouldbethatofa typicalcommercial orhospital environment Iftheuserofthe Archimederequires continuedoperationduringpower mainsinterruptions itisrecommended thattheArchimedebe poweredfroman uninterruptiblepower Supplyorabattery NOTE UT isthea c mainsvoltagepriortoapplication ofthetestlevel User Manual Version 1 15 Page 69 of 73 Electromagnetic compatibility Table 4 Guidanceandmanufacturer sdeclaration electromagneticimmunity TheArchimedeisintendedforuseintheelectromagneticenvironmentspecifiedbelow Thecustomer ortheuserof theArchimedeshouldassurethatitisusedinsuchanenvironment ESODO ita compliance Electromagneticenvironment guidance PortableandmobileRFcommunicationsequipmen t shouldbeusednoclosertoanypartoftheArchimede includingcables thantherecommended separationdistancecal
17. show the bag icon Open cover of HB sensor and insert the tube coming from the primary bag into the reading area Close the cover Insert the plasma tube firmly into the flow valve clamp 6 Insert the tube coming from the flow valve firmly into clamp 3 Insert RBC tube into clamp 4 Position the plasma bag on upper weight scale Position the RBC bag on lateral weight scale Archimede checks correct tubes positioning inside proper clamps by means of its optical sensors The tube is correctly inserted when the clamp number is replaced by the icon D only with tube control enable When all the bags and tubes are in position the text at the top right will be changed to START and the procedure start automatically Press START key button to start the procedure if the autostart doesn t happen If the primary bag expected weight check has been enabled through ArchimedeLINK and the measured weight does not fall within the defined limits a warning will be displayed showing both limits and current weight After verifying the cause of the problem confirm weight with Or press y to leave the procedure Furthermore if the tube presence check is enabled the display will show the clamp numbers where tubes are not correctly inserted and the procedure will not start until all tubes are correctly inserted into the enabled clamps In also if a bags is not recognized an error will be displayed Now wait for the plate to get close
18. side upper part and wait a few seconds for pressure reduction After detecting pressure decrease Archimede automatically starts the separation cycle If due to obstructions or tube kinks pressure circuit is not reduced below the threshold set it is anyway possible to force the cycle start by pressing START key button If the cannula breaking is not active 2 Archimede automatically starts the cycle of separation The graphic interface will now show the current operating phase number and the weight value of plasma collected Archimede will check if the parameter 6 is active the level of red blood cellsin the primary bag When this level reaches the selected IR sensor the display will show it in the area of the RBC pressing plate The photometer detecting the presence of erythrocytes will now check in real time the plasma flow When the erythrocytes amount exceeds the value set in procedure parameters the photometry will display RBC on the sensor cover icon and if dispensation of excess plasma 19 is not provided the separation process will stop and the plate will move backwards to allow Red Cell Additive Solution dispensing If air removal is enabled the system will send the air contained in the plasma bag into the selected bag Now remove tubes and bags and press START to continue with another separations of the same type or press to exit Page 32 of 73 User Manual Version 1 15 USING ARCHIMEDE 5 3 2PROCEDURE
19. standard procedures installed implemented and modified through ArchimedeLINK with the help of an application specialist Page 14 of 73 User Manual Version 1 15 GENERAL DESCRIPTION 3 GENERAL DESCRIPTION Archimede consists of two parts e The electronic part includes a built in microcontroller of the latest generation Through this microcontroller the instrument can store the procedures data control graphic display drives motors weight scale sensors clamps sealer group and RFID reader e The mechanical part includes an axial system enabling movement of plate and buffy coat separation system Picture 5 Global view 3 1 Upper Panel The upper panel is designed to house tubes and collection bags It includes Upper weight scales with weight capacity 0 2000 grams with 1 g resolution Photometer for red blood cells detection It consists of a 540 nm optical system and a couple of IR sensors for air bubbles detection A reflection optical systems detects cover state open closed and tube presence Three sealing head clamps Top Plasma and Buffy Coat One normal clamp for Red Cell Additive Solution One proportional valve for plasma flow control Holder for additional bag N e ia User Manual Version 1 15 Page 15 of 73 GENERAL DESCRIPTION 3 2 Front Panel The front panel is designed to hold the bag from which the blood components are to be extracted It includes 7 8 9 10 1
20. 1 12 13 Mobile separation plate controlled by one stepper motor and two sensors the first sensor detects the distance between plate and profile plate the second sensor detects the applied force Fix plate provided with holders where the bag in use can be hanged Primary bag support with pins for stainless steel cannula breaking with weight scales with weight capacity 0 2000 grams with 1 g resolution Frontal cannula breaker W B C B actuator that provides to break automatically the cannula of the primary bag hangs on frontal support optional Magnetic sensors Hall effect for detection of the type of profile plate in use Optical device for detection of buffy coat level It consists of 18 IR sensors linearly placed Clamp Bottom with sealing head 3 3 Lateral Panel i Ben Picture 6 Lateral Panel The right side panel includes the support for lateral weight scales and the magnetic and removable filter support The filter support is to be used if required by the selected procedure 14 15 16 Filter holder Lateral weight scales with plexiglass plate Lateral cannula breaker R C C B actuator that provides to break automatically the cannula of the lateral bag hangs on lateral support optional Page 16 of 73 User Manual Version 1 15 GENERAL DESCRIPTION 3 4 Rear Panel The rear side includes the main power socket and two connectors that enable data exchange with the barcode reader and with a ho
21. 19 3 6 4 Date and Time 20 4 USING ARCHIMEDE 21 AL SWICCHINS O N inni 21 4 2 System SEMMHCACCK sini ra 21 do ali DI Splay leciti 24 4 4 Use as a weight Scalea 25 4 5 Use as a sealing Unitaria iaia 25 4 6 Use as manual separator rr 26 5 Separation Procedure 27 FL SOUS SECM ia 28 5 2 Meaning of Procedure Parameters ccccesseceeecceseeceessecneeteenseunnnnes 28 bis PROCCUUres descriptio nane 29 5 3 1 PROCEDURE 1 T amp T triple PPP or PRP RCC 31 5 3 2 PROCEDURE 2 T amp T quadruple PPP or PRP BC RCC 33 5 3 3 PROCEDURE 3 Top amp Bottom triple PPP BC RCC 35 5 3 4 PROCEDURE 4 Top amp Bottom quadruple PPP BC RCC 37 5 3 5 PROCEDURE 5 Separation from PRP to PPP PLT 39 5 3 6 PROCEDURE 7 Single or Pool of Buffy for PLT residual BC with filter 41 5 3 7 PROCEDURE 8 Separation of Erythrocytes Washing 43 5 3 8 PROCEDURE 10 a UMBILICAL CORD 45 5 3 9 PROCEDURE 11 b ALIQUOT SEPARATION 47 5 3 10 PROCEDURE 12 c PLT BC from single Buffy Coat 49 5 3 11 PROCEDURE 13 d T amp T for RCC diluted in Plasma Predefined HCT 51 6 WEIGHT SCALE CALIBRATION 53 DATA TRANSFER 55 Pads LANG 55 2 WEAN Randall 55 7 3 Firmware Update and Procedures ProtocolS rr 55 8 TROUBLESHOOTING 57 8 1 Errors and Possible SOIUtions rr 57 8 2 Errors with Archimede codes rr 57 Page 8 of 73 User Manual Version 1 15 9 CONTENTS Maintenance Sl Daelly MalNeenanteai ea
22. 2 T amp T quadruple PPP or PRP BC RCC This procedure is suitable for top and top standard quadruple bags containing Red Cell Additive Solution It allows to separate erythrocytes RCC platelet poor plasma PPP and buffy coat or platelet rich plasma PRP and buffy coat platelets with weighing the plasma buffy coat and red blood cells Separation Description Clamp 3 Clamp 2 iam He Sag M bag Picture 16 Kit installation T T quadruple procedure Position bags and tubes according to the below sequence Be sure to avoid tensions and kinks that might cause flow obstruction or weighing errors Hang the primary bag on the bag holders of the front panel The label containing bag data Should always be turned outside After detecting the primary bag the plate will move backward to make positioning of Red Cell Additive Solution bag easier and the display will show the bag icon Hang the Red Cell Additive Solution bag to the bag holders on the fix plate Insert the Red Cell Additive Solution tube firmly into clamp 5 Open cover of HB sensor and insert the tube coming from the primary bag into the reading area Close the cover Insert the tube coming from the HB sensor firmly into clamp 1 Insert buffy coat tube into clamp 3 Insert the plasma tube into clamp 2 Position the plasma bag on upper weight scale Position the buffy coat bag on lateral weight scale Archimede checks correct tubes positi
23. ARCHIMEDE MOE1504 Automatic Blood Component Extractor Operator s Manual Operator Manual Version 1 15 Page 1 of 73 MOELCA s r l Via E Toti 101 22070 Limido Comasco CO ITALIA A 39 031 3520153 3520279 3524739 El Fax 39 031 3524732 E mailinfo moelca it C 06810 Manufacturer Responsibility The instructions for use may contain a declaration that the Manufacturer the Assembler the Installer or the Importer consider themselves responsible for instrument safety reliability and performance only if e assembling extensions adjustments changes or repairs are performed by qualified service personnel under his authorization e the instrument is operating in a room whose electrical system applies with the relevant prescriptions e the instrument is operating according to the instructions for use The device complies with part 15 of the FCC Rules Operation is subjected to the following 2 conditions 1 this device may not cause harmful interference and 2 this device must accept any interference received including interference that may cause undesired operation Changes or modifications not expressly approved by the party responsible for compliance could avoid the user s authority to operate the equipment COPYRIGHT All rights reserved The contents of this document may not be reproduced stored in a retrieval system transmitted in any form or electronic mean used for different aims without the prior written con
24. NG ARCHIMEDE 5 3 11 PROCEDURE 13 d T amp T for RCC diluted in Plasma Predefined HCT This procedure is suitable for triple bags to obtain diluted RCC in plasma with predefined haematocrit no additive solution and PPP Separation Description Position bags and tubes according to the below sequence Be sure to avoid tensions and kinks that might cause flow obstruction or weighing errors Picture 25 Kit installation procedure T amp T with predefined HCT Hang the primary bag on the bag holders of the front panel The label containing bag data should always be turned outside Open the cover of HB sensor and insert the tube coming from the primary bag into the reading area Close the cover Insert the tube coming from the HB sensor firmly into clamp 3 Position the plasma bag on upper weight scale Archimede checks correct tubes positioning inside proper clamps by means of its optical sensors The tube is correctly inserted when the clamp number is replaced by the icon DP only with tube control enable When all the bags and tubes are in position the text at the top right will be changed to START and the procedure start automatically Press START key button to start the procedure if the autostart doesn t happen If the primary bag expected weight check has been enabled through ArchimedeLINK and the measured weight does not fall within the defined limits a warning will be displayed showing both limits an
25. NT BUFFY COAT Cause 1 Remedy Cause 2 Remedy The buffy coat amount set in the procedure is higher than the amount collected Verify actual value Scales not calibrated Calibrate scale see scales calibration INSUFFICIENT SAG M WEIGHT Cause 1 Remedy Cause 2 Remedy Sag M amount is insufficient to complete the procedure Check actual amount and confirm Scales not calibrated Calibrate scales see scales calibration CHECK SAG M FLOW Cause 1 Remedy Cause 2 Remedy Cause 3 Remedy Sag M tube folded or collapsed Adjust bag tube and remove obstructions Clamp 5 closed Unlock clamp 5 Call Authorized Service Center Scales not calibrated Calibrate scales see scales calibration LIMIT SWITCH REACHED WITH INSUFFICIENT SAG M Cause 1 Remedy Cause 2 Remedy Sag M bag lacking The system has detected the all opened plate sensor without dispensing Sag M Position Sag M bag Defective open plate sensor Call Authorized Service Center User Manual Version 1 15 Error 43 Error 44 Error 45 Error 46 Error 47 Error 48 Error 50 TROUBLESHOOTING RBCS NOT DETECTED Cause 1 Remedy Cause 2 Remedy Cause 3 Remedy Cause 4 Remedy CHECK FLOW Cause 1 Remedy Cause 2 Remedy Cause 3 Remedy NOT IN USE Wrong action threshold Check value of parameters 8 Wrong distance threshold Check value of para
26. PROCEDURE through BC reading of the type of bag 3 6 2Enable procedure list ENABLED PROCEDURES LIST 1 T amp T triple PPP or PRP RBC 2 T amp T quad PPP or PRP BC RBC 3 T amp B triple PPP BC RBC Picture 8 Enable procedures list Se Lu Using the arrows highlights the procedure you intend to use then press to start the procedure selected by 3 6 3 Utility menu VO To enter this menu press L key button above the icons and use direction key button w to select the desired function UTILITY MENU CALIBRATION PARAMETER LIST OPERATOR LIST CONTRAST MAINTENANCE Firmware x XX Picture 9 Utility menu CALIBRATION Allows to calibrate the three weight scales of Archimede by choosing the desired weight PARAMETER LIST Allows to display the numerical values of all parameters of the procedures established OPERATOR LIST Allows you to view the list of codes associated with the use of authorized operators Archimede CONTRAST Allows to adjust display contrast MAINTENANCE Allows you to view the list of active maintenance and execute them only when connected to ArchimedeLINK User Manual Version 1 15 Page 19 of 73 GENERAL DESCRIPTION 3 6 4Date and Time Although the display normallyshows only hours and minutes Archimede is provided with built in calendar used to send to ArchimedeLI NK procedure data including date and time as re ae Using direction key buttons A highligh
27. SO 12100 2 2003 A1 2009 EN ISO 13857 2008 EN 349 1993 Compliance P R amp S MPETR_110481 0 31 05 2011 Notified Body EN 62311 2008 Compliance P R amp S SAFTR_110233 1 14 03 2011 Notified Body EN 60601 1 2006 10 Compliance P R amp S ETSTR_110479 0 14 06 2011 Notified Body EN 300 328 V1 7 1 2006 10 Compliance P R amp S ETSTR_110480 0 10 05 2011 Notified Body EN 300 330 1 V 1 7 1 2010 02 EN 300 330 2 V 1 5 1 2010 02 Ministero della DGFDM II1 P Free Sales Certificate 24 02 2011 Salute 1 5 1 e 1 2010 61 0 COSETTE TO Please contact info moelca it to request this latest EC declaration of conformity User Manual Version 1 15 Page 73 of 73
28. aking is active 2 the message Break cannulas will be displayed Break the cannulas by forcing on their side upper part and wait a few seconds for pressure reduction After detecting pressure decrease Archimede automatically starts the separation cycle If due to obstructions or tube kinks pressure circuit is not reduced below the threshold set it is any way possible to force the cycle start by pressing START key button If the cannula breaking is not active 2 Archimede automatically starts the cycle of separation The graphic interface will now show the current operating phase number and the weight value of plasma collected Archimede will check the bags weights When the desired volume is reached the relevant clamp will be close After the last aliquot the plate will move backwards to standby position Archimede will automatically send to ArchimedeLINK all events and data of the procedure performed At the end of the procedure the display will show the detected weights If they are not the expected ones because tubes are not correctly placed and distort weight scale readings the blood components can be weighed again after correcting tubes position and the new weights can be sent to ArchimedeLI NK Correct weights if you remove all the tubes and all the bags Archimede will automatically start a procedure of the same type You can force the process by pressing the button to continue with the same type of separation To go
29. as selected the type of procedure to be used it is not longer possible to modify the answer to donation ID and operator ID Actually the choice criteria of the procedure take into consideration both operator s privileges and status of primary and secondary separation Example if a bag has already been processed as primary secondary procedure ArchimedeLINK will not allow the separation unless an operator having the appropriate privileges forces it to do so To clear the series of questions and return to main menu press Mi When all questions have been replied to the initial display of the selected procedure will automatically appear 5 2 Meaning of Procedure Parameters During the separation procedureArchimedeoperation is affected by several parameters Some of these parameters are fix that is preset by the management program Other parameters are variable that is settable by an application engineer through an external PC and ArchimedeLink AII variable parameters are factory preset and saved in a non volatile memory with elevated retention capacity Fix parameters are used to monitor all the events with top priority alarm i e time necessary to enable all actuators very long Red Cell Additive Solution dispensing time very long etc In order to obtain a better management procedure parameters are divided into group For a detailed explanation see service manual Page 28 of 73 User Manual Version 1 15 USING ARCHIMEDE 5 3 Proce
30. asma bag in vertical position press START key button to open clamp 3 and remove air manually by pressing on the bag When finished press stor key button to close clamp 3 and re position plasma bag to detect weight The process will continue automatically Now remove tubes and bags and press START to continue with another separation of the same type or press to exit Page 42 of 73 User Manual Version 1 15 USING ARCHIMEDE 5 3 7PROCEDURE 8 Separation of Erythrocytes Washing This procedure allows to separate the washing fluid from erythrocytes subjected to a washing procedure Separation Description A i HB Sensor Scale 1 He Picture 21 Kit installation procedure erythrocytes washing Position bags and tubes according to the below sequence Be sure to avoid tensions and kinks that might cause flow obstruction or weighing errors Hang the primary bag on the bag holders of the front panel The label containing bag data Should always be turned outside After detecting the primary bag the plate will move backward to make positioning of Red Cell Additive Solution bag easier and the display will show the bag icon Open cover of HB sensor and insert the tube coming from the primary bag into the reading area Close the cover Insert the tube coming from the HB sensor firmly into clamp 1 Position the washing fluid bag on upper weight scale Archimede checks correct tubes positioning inside proper clamps by means
31. ch If limit switches are not activated within the preset travel limits an error alarm will be sent and displayed If the problem persists please see the Troubleshooting section Same as stand alone mode IR sensors IR sensors check and self calibration If IR sensors have an elevated dark current or a low sensibility an error alarm will be sent and displayed If the problem persists please see the Troubleshooting section Same as stand alone mode HB sensor HB sensor check and self calibration If the HB sensor has an elevated dark current or a low sensibility an error alarm will be sent and displayed If the problem persists please see the Troubleshooting section Same as stand alone mode Proportional clamp Check movement actuator If the limit switch is not activated within the preset travel limits an error alarm will be sent and displayed If the problem persists please see the Troubleshooting section Same as in stand alone mode Weight scales Tare check of all weight scales If the tare values are not within the preset limits an error alarm will be sent and displayed If the problem persists please see the Troubleshooting section Same as in stand alone mode User Manual Version 1 15 Page 23 of 73 USING ARCHIMEDE 4 3 Main Display To access the various functions there are two different ways X With the arrow keys moves the selection visible through the highlight of the frame o
32. ction the Archimede is typically used in a laboratory environment with no patient connected to the instrument The Archimede is not intended by the manufacturer to measure a quantitatively a physiological or anatomical parameter or a quantity or a qualifiedly characteristic of energy or of substances delivered to or removed from the human body The instrument is not intended to display a measurement from which an operator is required to make a diagnostic or interpretative decision affecting the patient s health and safety Class I non sterile accessory without measuring function to a medical device according to the Council Directive 93 42 EEC and following modifications 2007 47 EU of 21 03 2010 International protection I P41 Number MOELCA S r l EC Declaration of Conformity Archimede Version COSE 3 1 Medical Device Directive a eee MOELCA S r l EC Declaration of Conformity Archimede 3 1 19 09 2011 R amp TTE directive MOELCA S r l E7M 1109 1374 C Expert Opinion the Notified Body based on the 19 09 2011 Conformity Assessment according to Annex IV of the R amp TTE Directive 1999 5 EC Prima Ricerca amp Sviluppo Archimede Certificate Notified Body of Conformity Compliance P R amp S EMCTR_110232 4 EN 60601 1 2 2007 18 05 2011 Notified Body EN 301 489 1 V 1 8 1 2008 04 EN 301 489 17 V 2 1 1 2009 05 Compliance P R amp S MACTR_ EN ISO 12100 1 2003 A1 2009 12 05 2011 Notified Body 110482 OA EN I
33. culatedfromtheequatio n applicable tothefrequency ofthetransmitter ConductedRF IEC61000 3Vrms Recommendedseparationdista nce 4 6 150kHzto80MHz d 0 35P d 0 35 P 80 MHz to 800 MHz RadiatedRF 3V m d 0 7P 800 MHz to 2 5 GHz 1EC61000 4 3 SOMHzto2 5GHz wherePisthemaximumoutputpowerratingofthe transmitter inwatts W accordingtothetransmitter manufactureranddistherecommendedseparatio n distanceinmetres m Fieldstrengths fromfixedRFtransmitters asdeter minedbyanelectromagneticsitesu rvey shouldb e lessthanthecompliance levelineachfrequency pange Interferencemayoccurinthevicinityofequipmen t markedwiththefollowingsymbol C NOTE1 At80MHzand800MHz thehigherfrequency rangeapplies NOTE2 Theseguidelinesmaynotapplyinallsituations Electromagneticpropagationisaffectedbyabsorption andreflectionfromstructures objectsandpeople Fieldstrengthsfromfixedtransmitters suchasbasestationsforradio cellular cordless telephonesandland mobileradios amateurradio AMandFMradiobroadcastandTVbroadcastcannotbepredictedtheoretically withaccuracy ToassesstheelectromagneticenvironmentduetofixedRFtransmitters anelectromagneticsite surveyshouldbe considered If the measuredfieldstrengthin the locationin whichthe ModelArchimedeis used exceeds the applicable RF compliance level above the Model Archimedeshould be observed to verify normal operation Ifabnormalperformanceisobserved additionalmeasuresmaybenecessary suchasre orientingor relocatin
34. d current weight After verifying the cause of the problem confirm weight with Or press A to leave the procedure Furthermore if the tube presence check is enabled the display will show the clamp numbers where tubes are not correctly inserted and the procedure will not start until all tubes are correctly inserted into the enabled clamps In also if a bags is not recognized an error will be displayed Now wait for the plate to get close to the bag The plate will apply a force corresponding to the value set in the procedure parameters 3 If the automatic breaking cannula 45 is active the Archimedebreakes automatically the cannulas and starts the separation cycle it is available only if this optional is installed User Manual Version 1 15 Page 51 of 73 USING ARCHIMEDE If the cannula breaking is active 2 the message Break cannulas will be displayed Break the cannulas by forcing on their side upper part and wait a few seconds for pressure reduction After detecting pressure decrease Archimede automatically starts the separation cycle If due to obstructions or tube kinks pressure circuit is n duced below the threshold set it is any way possible to force the cycle start by pressing key button If the cannula breaking is not active 2 Archimede automatically starts the cycle of separation The graphic interface will now show the current operating phase number and the weight value of plasma collected Archimede will check the
35. defective Remedy Call Authorized Service Center CALI BRATION POSITION DISTANCE SENSOR VOLTAGE gt 4600 mv Cause 1 Mechanical obstructions prevent plate movement User Manual Version 1 15 Error 29 1 4 Error 30 Error 31 Error 32 1 4 Error 33 Error 34 TROUBLESHOOTI NG Remedy Remove any obstruction Cause 2 Defective linear sensor Remedy Call Authorized Service Center WET OR DIRTY ELECTRODES IN SEALI NG HEAD Cause 1 Sealing heads wet or dirty Remedy Clean and dry sealing heads electrodes Press key button to open the clamp in error insert tube again and press to perform sealing again If a procedure is ongoing press to continue Cause 2 Defective sealing head or CSU Remedy Call Authorized Service Center SEALI NG UNIT BUSY Cause 1 CSU cable disconnected Remedy Check and connect cable Cause 2 Defective CSU Remedy Call Authorized Service Center TUBE IN THE CLAMP Cause 1 Tubes are inserted to clamps during self diagnosis Remedy Remove tubes from clamps and repeat self diagnosis cycle Cause 2 Defective tube sensor Remedy Call Authorized Service Center ELEVATED LOAD CELLS OFFSET Cause 1 Bags or weights positioned on the scales during self diagnosis Remedy Remove any bags or weights from the scales during self diagnosis cycle Cause 2 Defective offset digital system Remedy Call Authorized Service Center ELEVATED FLOW VALVE CHECK CYCLE Cause 1
36. device a complete self check of the system is performed Before switching Archimede on it is therefore necessary to remove any bag and check that the bags holders are free and correctly placed After plugging the power cable turn on the main switch on instrument rear The display should be back lighted and will show ARCHIMEDE If not check that the power cable is well plugged and that the power socket in use is powered If the display does not light up please see Troubleshooting section 4 2 System Self check Every time it is turned on Archimede performs a self check to verify proper system operation SELF TEST IN PROGRESS Picture 11 Screen shot Self Test in progress The actions performed following a negative check depend on the connection mode Stand Alone ArchimedeLI NK E prom Memory Check of data integrity concerning calibration and procedure parameters If data are incorrect the system after confirmation will initialize them and restore the factory set values In this case weight scales calibrations are required Procedure data are restore to factory set values while calibration data will require a new calibration User Manual Version 1 15 Page 21 of 73 USING ARCHIMEDE Clock Date and time check If date and time values are incompatible with the format the system after confirmation will initialize them at 00 00 00 01 06 11 Synchronization with data and time of A
37. dures description Common Operations to all procedures I nitial screen show the following information b II The status of the procedure separation or pause The clamp visible are those actually used for the separation and sealing The sensor HB with its status open or closed with or without tube il The force read by the sensor Last 4 digits of the operator code if you read above On the left the number that indicates the type of procedure while on the right the number of sequential procedures Estimated percentage of time The time of separation from breaking cannula to end of sealing de A Read comments you can read comments if connected to ArchimedeLINK The comments labels are available on the outside of the front plate in place BCL Buffy Coat Level SET Buffy coat set level ACT Actual buffy coat level STOP If you need to interrupt the procedure either momentarily or definitively press STOR key button Stop press STOR or E Archimede will display the sealing page and send data to ArchimedeLI NK Pause press START Or y to continue the procedure INSTRUMENT BODY CAUTION DO NOT PUT YOUR HANDS IN THE PLATE WORKING AREA WHEN THE PLATE IS MOVI NG W ATTENTION THE FORCE SENSOR IS ENABLED ONLY WHEN THE PLATE MOVES TOWARDS THE Sealing The sealing cycle depends on the value set in the procedure parameters 11 and 12 Automatic sealing sealing cycle of the selected clamps is performed auto
38. e 1 A D converter stuck Remedy Turn Archimede OFF and ON ADC UNDERFLOW DURI NG SCALES X TARE Cause 1 Scales holder is not in correct position Remedy Check that scales holders are correctly mounted and free from obstructions Turn Archimede OFF and ON User Manual Version 1 15 Error 13 1 4 Error 14 1 4 Error 15 1 4 Error 16 1 18 Error 17 1 18 Error 18 1 18 Error 19 Error 20 TROUBLESHOOTI NG SCALES X TARE IS OVER LI MI TS Cause 1 Scales holder is not in correct position AD input circuit not compensated Remedy Check that scales holders are correctly mounted and free from obstructions Turn Archimede OFF and ON IN SEPARATI ON MODE TARE X VALUE IS OVER RANGE Cause 1 Weight detection circuit output 1000 mV Remedy Remove any extra weight from the cradle Call Authorized Service Center K SCALES X VALUE OVERRANGE Cause 1 During calibration the system has checked that scales calibration factor is over limit The value of standard weight in use does not correspond to the value set during calibration Remedy Repeat calibration Call Authorized Service Center LUMI NOSI TY Cause 1 There is too much light in the room IR dark voltage gt 500 mV Remedy Reduce environment luminosity Cause 2 IR sensor is defective Remedy Call Authorized Service Center IR SENSOR SENSITIVITY TOO LOW Cause 1 IR sensor does not detect sufficient difference between li
39. e I CODE SLI and Tag_it n Omni directional bar code reader n Cannula breaker for W B cannula and for R C cannula 11 DISPOSAL When disposing materials please observe the following recommendations 11 1 Packing Material Disposal e Throw packing materials in the proper separate collection containers e In case of doubts please ask the blood centre responsible for information about proper separate collection 11 2 ArchimedeDisposal e If Archimede is no longer usable please bring it to the area separate collection centre or e Ask the nearest Technical Service authorized centre Separate waste collection EN _ 2002 96 EC For product disposal ensure the following e Do not dispose of this product as unsortedmunicipal waste e Collect this product separately e Use the collection and return systems availableto you For more information on return recovery orrecycling of this product please contact yourlocal service representative Page 66 of 73 User Manual Version 1 15 User Manual Version 1 15 Page 67 of 73 Electromagnetic compatibility 12 ELECTROMAGNETIC COMPATIBILITY The following information needs to be provided according to IEC 60601 1 2 2007 Archimede as well as all medical electrical equipment needs special precautions regarding EMC electromagnetic compatibility and needs to be installed and put into service according to the following information Because the intensity of electromagnetic energy
40. e is stable to confirm Repeat the above steps with upper weight scales 2 and lateral weight scales 3 User Manual Version 1 15 Page 53 of 73 CALI BRATI ON CALI BRATI ON K Current 1 0009 Scale 1 1 0001 Scale 2 1 1452 Scale 3 Press ENTER to accept Press ESC to exit Picture 30 Calibration factors display Verify calibration factors calculated for front weight scales 1 upper weight scales 2 and lateral weight scales 3 Press to confirm factors and save them or press to restore the previous calibration factors Page 54 of 73 User Manual Version 1 15 DATA TRANSFER 7 DATA TRANSFER With LAN or WLAN Archimede can dialogue in bidirectional mode with ArchimedeLI NK This allows data transfer from severalArchimede units even if located several meters distant from the PC where ArchimedeLI NK server is installed M_ wi mT a 7 1 LAN Picture 31 LAN connection Every Archimede connected to an IP network must have a unique IP address and if DHCP mode is enable IPaddress is automaticallyassigned Communication takes place through the identification of Archimede sunique serial number 7 2 WLAN Picture 32 WLAN connection A 802 11 b g wireless LAN should be installed on the PC to be used Communication takes place through the identification of Archimede sunique serial number This allows ArchimedeLINK to communicate with more units installed and switched on w
41. ear left is in 0 position Then plug the Barcode Reader into the socket marked with Plug the power cord and turn the main switch on position 1 ARCHIMEDE Rev xxx Picture 2 Archimede display Note If Archimede is not in Stand Alone mode but is connected with ArchimedeLINK in WLAN before proceed with the other controls it is necessary to set LAN WLAN parameters This configuration is described in the service manual at the paragraph configuration LAN WLAN Page 12 of 73 User Manual Version 1 15 INSTALLATI ON When the display lights on instrument model and firmware software revision number should appear SELF TEST IN PROGRESS Picture 3 Screen shot Self Test After verifying and initializing all data stored Archimede performs a self check of all measurement systems In case of malfunction the display shows the problem detected and the possible remedy Press Plate Area MT PT W ATTENTION DO NOT PUT YOUR HANDS IN THE FRONTAL PRESS PLATE WORKING AREA User Manual Version 1 15 Page 13 of 73 INSTALLATI ON 2 5 Instrument Setup All sensitive data are stored and saved in a non volatile RAM They can be modified using ArchimedeLI NK Date and time are managed by a dedicated rtccircuit If without main power it may operate for about 60 days However if Archimede does not operate in stand alone mode date and time are automatically updated when switching the instrument on
42. ed After the plate will return in open postion if parameter 36 is set a quantity of plasma will be dispense by gravity in the Buffy Coat bag If parameter 35 is set before dispensing the Red Cell Additive Solution into RBC bags will be kept open the Buffy Coat clamp to clean the BC line Afterward the remaining quantity of Red Cell Additive Solution will be released into RBC bag If air removal is enabled the system will send the air contained in the primary bag to the Red Cell Additive Solution bag both at initial and final stage Now remove tubes and bags and press to continue with another separation of the same type or press to exit Page 34 of 73 User Manual Version 1 15 USING ARCHIMEDE 5 3 3PROCEDURE 3 Top amp Bottom triple PPP BC RCC This procedure is indicated for triple top amp bottom bags to obtain buffy coat BC erythrocytes RCC and plasma PPP Separation Description Scales2 2 Clamp 6 Fi Am Clamp 4 Scales 1 Picture 17 Kit installation T B triple procedure Position bags and tubes according to the below sequence Be sure to avoid tensions and kinks that might cause flow obstruction or weighing errors Hang the primary bag on the bag holders of the front panel The label containing bag data Should always be turned outside After detecting the primary bag the plate will move backward to make positioning of Red Cell Additive Solution bag easier and the display will
43. eight scales tray and decontaminate both tray and holder with bleach or disinfectant Do not hit the mechanical device supporting the tray and do not pour liquids inside the central gap Decontaminate also flow valve actuator clamps actuators and optical sensors with a cotton dubs dampened with bleach or disinfectant Rinse with water all parts treated with bleach or disinfectant Warning Never use alcohol acetone trichloroethylene or any solvents 9 1 3Monthly Maintenance Monthly maintenance simply consists of checking the calibration of all weight scales using certified weights If the readings don t fall within the allowed ranges please contact the authorized technical service centre 9 2 Yearly Maintenance Yearly maintenance is performed by qualified engineers authorized by manufacturer Before cleaning with any liquid turn Archimede off and disconnect the power cable 9 3 Maintenance Recording This function is enabled only when Archimede is connected to ArchimedeLINK In this case all maintenance operations can be stored sending to ArchimedeLINK data relevant to maintenance operator and date of performance i lt gt lt To confirm the action done select the desired maintenance using the arrows confirm with and read the operator code User Manual Version 1 15 Page 65 of 73 DISPOSAL 10 ACCESSORIES Archimede can be supplied with RFID reader for labels or cards type RFID ISO15693 Supported tags ar
44. emperatures elevated humidity See Chapter 13 Technical features of this manual Proximity of free flames Direct sunlight exposure Elevated dust accumulation Proximity of flammable substances Unstable and non flat surfaces or slippy Separation distance of 20 cm must be maintained between the WLAN antenna and human bodies 2 3 Assembling weight scale filter holders and antenna Screw the two hexagonal screws in the holes that are on Archimede left side place one of the plates with holes and then the plexiglas panel put the other plate and screw the knurl metal parts Screw the side weight scales holders paying attention to the load cells the load cells are mechanically protected but they should not be hit with force Screw antenna and place it in vertical position The filter holder is magnetic and can be put in the most suitable position to support the filter during the procedures requiring filter use 2 4 Switching on Archimede The power cord must be plugged into a grounded power receptacle When using an extension cord make sure it is properly grounded Any rupture of the ground lead inside or outside the instrument or a loose ground connection may result in hazardous operating conditions for the operating personnel Intentional disconnection of the grounding is not permitted The correct value of line voltage and line fuses are indicated on the rear plate of the instrument gt Check that mains power switch on r
45. er weight scale Archimede checks correct tubes positioning inside proper clamps by means of its optical sensors The tube is correctly inserted when the clamp number is replaced by the icon D only with tube control enable When all the bags and tubes are in position the text at the top right will be changed to START and the procedure start automatically Press START key button to start the procedure if the autostart doesn t happen If the primary bag expected weight check has been enabled through ArchimedeLINK and the measured weight does not fall within the defined limits a warning will be displayed showing both limits and current weight After verifying the cause of the problem confirm weight with Or press y to leave the procedure Furthermore if the tube presence check is enabled the display will show the clamp numbers where tubes are not correctly inserted and the procedure will not start until all tubes are correctly inserted into the enabled clamps In also if a bags is not recognized an error will be displayed Now wait for the plate to get close to the bag The plate will apply a force corresponding to the value set in the procedure parameters 3 If the automatic breaking cannula 45 is active the Archimedebreakes automatically the cannulas and starts the separation cycle it is available only if this optional is installed User Manual Version 1 15 Page 49 of 73 USING ARCHIMEDE If the cannula breaking is active
46. erythrocytes level and distance in primary bag When this level reaches the HCT target will stop and the plate will move backwards Now remove tubes and bags and press to continue with another separation of the same type or press to exit Page 52 of 73 User Manual Version 1 15 CALIBRATION 6 WEIGHT SCALE CALIBRATION Weight scales calibration can be performed only when Archimede has been switched on for a few minutes This is necessary for measuring sensors to reach thermal stabilization A set of certified weights is also necessary _ To enter calibration press the L key button above the icon and select CALIBRATION _ BQ using direction key buttons UTILITY MENU vV CALIBRATION PARAMETER LIST OPERATOR LIST CONTRAST MAINTENANCE Firmware x XX Picture 26 Calibration menu Confirm by pressing E CALI BRATI ON Sample weight Picture 27 Calibration sample weight setting VO Select the sample weight value you intend to use for calibration using og key buttons then i Enter confirm pressing CALI BRATION Remove any weight from frontal scale Press ENTER Picture 28 First step calibration To perform tare remove any weight from the front weight scales and then confirm pressing CALI BRATION Position 1000 g on frontal scale Frontal reading 498 g Press ENTER Picture 29 Second step calibration Position the selected sample weight When the displayed valu
47. f the icon With the function keys you select the function below or above the key This menu allows to enter submenus to have calibration parameters list operator list and maintenance actions displayed Press to login operator by bar code reader The instrument status is displayed in this area Current time is displayed in this area If upper function key is pressed allows to change the date and time This menu allows to set the tare and to have front weight scale upper weight scales and side weight displayed CAL Date of the last weight scales calibration is displayed in this area This function allows to move back and forth the pressing plate gt gt m 44 This function allows to open and close the selected clamp The arrow appears when the sealing is activated READ BAG TYPE This function allows to enter the menu to select the desired procedure OR SELECT The procedure can be selected manually or through BC reading of the THE PROCEDURE type of bag Page 24 of 73 User Manual Version 1 15 USING ARCHIMEDE 4 4 Use as a weight scale Archimedecan be used as a weighing system thanks to its three load cells The maximum measurable weight is 2 Kg with 1 g resolution Before using the system as a weight scale it is necessary to calculate the tare Move the cursor using the arrows until the word zero is displayed in the weight scales area of the screen and press to zero
48. g e Detection system of force exerted by the plate e 4 sealing head clamps 1 normal clamp and one flow valve e 18 optical sensors to detect buffy coat level e Optical device to detect red blood cells presence e Many separation procedures stored up to a maximum of 18 e LAN and WLAN for bi directional data transfer of procedure and configuration data e PS2 port for external barcode reader or keyboard connection e Adjustable sealing time from 0 5 to 4 seconds frequency 40 68 MHz e Latex free e Environmental requirements Temperature between 5 C and 45 C Humidity lower than 80 without condensation e Power supply 90 VAC 84 W 1A 250 VAC 81 W 0 4A N 2 fuses T2 AT 250 VAC e Dimensions Width 435 depth 500 height 425 mm e Noise Level lt 65 dBA e Weight 39Kg without any optionals e Transport and storage From 20 C to 70 C relative humidity from 20 temperature to 90 without condensation e British Thermal Unit 300 BTU h MANUFACTURER MOELCA s r l AAA Via E Toti 101 22070 Limido Comasco CO ITALIA amp 39 031 3520153 3520279 3524739 a Fax 39 031 3524732 Email info moelca it User Manual Revision 1 13 Page 72 of 73 Certifications 14 ARCHIMEDE APPLICABLE STANDARD REGULATION LIST AND CERTIFICATIONS The Archimede is a non sterile accessory MDD 93 42 EEC article 1 2 b to the Blood Pack Units which are medical devices in the scope of the 93 42 EEC Directive Without measuring fun
49. gtheModelArchimede b Overthefrequency range150kHzto80MHz fieldstrengthsshouldbelessthan3V m Page 70 of 73 User Manual Version 1 15 Table 6 Recommendedseparationdistancesbetw een portableandmobileRFcommunicationsequipmentandtheModel The Archimedeis intended for use in an electromagnetic environment in which radiated RF disturbances are controlled ThecustomerortheuseroftheArchimedecanhelppreventelectromagneticinterferencebymaintaining aminimumdistancebetweenportableandmobileRFcommunicationsegquipment transmitters andtheArchimede Separationdistanceaccordingtofrequency Ratedmaximumoutputpow oftransmitter Srortransmitter 150kHzto80MHz 80MHzto800MHz 800MHzto2 5GHz d 0 7P For transmittersrated at a maximumoutputpowernot listed above the recommendedseparationdistanced in metres m can be estimated using the equation applicable to the frequency of the transmitter where Pis the maximumoutputpowerratingofthetransmitterinwatts W according tothetransmittermanufacturer NOTE1 At80MHzand800MHz theseparation distanceforthehigherfrequency rangeapplies NOTE2 These guidelinesmaynotapplyinall situations Electromagnetic propagationisaffectedby absorptionand reflectionfromstructures objectsandpeople User Manual Version 1 15 Page 71 of 73 TECHNICAL FEATURES 13 TECHNICAL FEATURES e Painted metal case e Graphic backlight display 240 x 128 e 3 load cells for 2 kg non linearity 0 02 F S repeatability 0 02 F S resolution 1
50. imits Press any key to continue Now remove tubes and bags and press START to continue with another separations of the same type or press to exit Page 30 of 73 User Manual Version 1 15 USING ARCHIMEDE 5 3 PROCEDURE 1 T amp T triple PPP or PRP RCC This procedure is suitable for triple bags with or without Red Cell Additive Solution It allows erythrocytes separation RCC and platelet poor plasma PPP or platelet rich plasma PRP weighing the plasma and red blood cells Separation Description Ei Scales 1 Picture 15 Kit installation procedure T T triple Position bags and tubes accordingly to the below sequence Be sure to avoid tensions and kinks that might cause flow obstruction or weighing errors Hang the primary bag on the bag holders of the front panel The label containing bag data should always be turned outside After detecting the primary bag the plate will move backward to make positioning of Sag M bag easier and the display will show the bag icon Hang the Red Cell Additive Solution bag to the bag holders on the fix plate Insert the Red Cell Additive Solution tube firmly into clamp 5 Open the cover of HB sensor and insert the tube coming from the primary bag into the reading area Close the cover Insert the tube coming from the HB sensor firmly into clamp 3 Position the plasma bag on upper weight scale Archimede checks correct tubes positioning inside proper clamps by mean
51. ing START key button If the cannula breaking is not active 2 Archimede automatically starts the cycle of separation The graphic interface will now show the current operating phase number and the weight value of plasma collected The operating phase depends on the distance set in the procedure parameters Archimede will check the plate distance The distance sensor will stop the separation process when the plate reaches the distance set in the parameters 18 or the quantity set in the parameter 30 Then the plate will move backword to standby position Now remove tubes and bags and press START to continue with another separation of the same type or press to exit Page 40 of 73 User Manual Version 1 15 USI NG ARCHI MEDE 5 3 6PROCEDURE 7 Single or Pool of Buffy for PLT residual BC with filter This procedure allow to use double bags for the collection of platelets from single or pools of Buffy Coat with filter for platelets PLT and Buffy Coat residue Res Separation Description n N i n ie a E i ima ne J Picture 20 Kit installation procedure PLT with filter Position bags and tubes according to the below sequence Be sure to avoid tensions and kinks that might cause flow obstruction or weighing errors Hang the primary bag on the bag holders of the front panel The label containing bag data Should always be turned outside After detecting the primary bag the plate will move backward to
52. ithin a 50 meters distance aroung the computer Caution Consult accompanying documents according to the European Standard EN980 7 3 Firmware Update and Procedures Protocols e The use of ArchimedeLl NK allows to e Update Archimede s internal firmware Firmware updating should preferably be performed by qualified engineers authorized by manufacturer User Manual Version 1 15 Page 55 of 73 DATA TRANSFER e Enter new procedures up to a maximum of 18 New procedures creation should preferably be performed by application engineers having detailed knowledge of the various procedure parameters functions e Modify procedure parameters This should be done by trained operators or by application engineers in order to avoid entering unsuitable values for the regular bag press operation e Verify correct operation of all device components connected to Archimede This operation should be performed by qualified engineers authorized by manufacturer Page 56 of 73 User Manual Version 1 15 TROUBLESHOOTI NG 8 TROUBLESHOOTING Archimede checks continuously that the device components connected work correctly In case it detects an error that cannot be eliminated through the dedicated algorithms the instrument displays the error 8 1 Errors and Possible Solutions Error 1A THE INSTRUMENT DOES NOT TURN ON Cause 1 Main power is lacking Remedy Check that main voltage is present and that the power cord is correctly plugged
53. lve and valves 3 and 4 The distance sensor will stop the separation process when the VOLUME OF Buffy coat reaches the value set in parameter 18 Now remove tubes and bags and press START to continue with another separation of the same type or press to exit Page 46 of 73 User Manual Version 1 15 USING ARCHIMEDE 5 3 9PROCEDURE 11 b ALI QUOT SEPARATI ON This procedure allows to separate blood components in the four available bags by weighing them separately Separation Description First the volumes are loaded from the parameters 14 29 and 39 If the volumes shown are those you want press to proceed with the positioning of the bags Otherwise if you gt lt gt ha want to change the volume setting press arrows up and down gt ha To change the bag selection press the left and right arrows while to disable a bag just reset the volume or press i Picture 23 Kit installation aliquot separation procedure Position bags and tubes according to the below sequence Be sure to avoid tensions and kinks that might cause flow obstruction or weighing errors Hang the primary bag on the bag holders of the front panel Insert tubes from the bags on upper weight scales firmly into clamps 1 and 3 Insert tubes from the bags on lateral weight scales firmly into clamp 2 If selected position the bag 1 on upper weight scale If selected position the bag 2 on upper weight scale If selected positi
54. m confirm weight with or press y to leave the procedure Furthermore if the tube presence check is enabled the display will show the clamp numbers where tubes are not correctly inserted and the procedure will not start until all tubes are correctly inserted into the enabled clamps In also if a bags is not recognized an error will be displayed User Manual Version 1 15 Page 45 of 73 USING ARCHIMEDE Now wait for the plate to get close to the bag The plate will apply a force corresponding to the value set in the procedure parameters 3 If the automatic breaking cannula 45 is active the Archimedebreakes automatically the cannulas and starts the separation cycle it is available only if this optional is installed If the cannula breaking is active 2 the message Break cannulas will be displayed Break the cannulas by forcing on their side upper part and wait a few seconds for pressure reduction After detecting pressure decrease Archimede automatically starts the separation cycle If due to obstructions or tube kinks pressure circuit is not reduced below the threshold set it is any way possible to force the cycle start by pressing START key button If the cannula breaking is not active 2 Archimede automatically starts the cycle of separation The graphic interface will now show the current operating phase number and the weight value of plasma collected Archimede will check the buffy coat level through IR sensors flow va
55. make positioning of Red Cell Additive Solution bag easier and the display will show the bag icon Insert the tube coming from the primary bag into clamp 4 Open cover of HB sensor and insert the tube coming from filter into the reading area Close the cover Insert the tube coming from the HB sensor firmly into clamp 1 Position the PLT bag on upper weight scale Archimede checks correct tubes positioning inside proper clamps by means of its optical sensors The tube is correctly inserted when the clamp number is replaced by the icon D only with tube control enable When all the bags and tubes are in position the text at the top right will be changed to START and the procedure start automatically Press START key button to start the procedure if the autostart doesn t happen If the primary bag expected weight check has been enabled through ArchimedeLINK and the measured weight does not fall within the defined limits a warning will be displayed showing both limits and current weight After verifying the cause of the problem confirm weight with or press y to leave the procedure Furthermore if the tube presence check is enabled the display will show the clamp numbers where tubes are not correctly inserted and the procedure will not start until all tubes are correctly inserted into the enabled clamps In also if a bags is not recognized an error will be displayed Now wait for the plate to get close to the bag The pla
56. matically Manual sealing press START key button to seal the enabled lines or press STOR then to continue without sealing NOTE Tubes in the various kits have different lengths To simplify kits management the firmware allows to configure which clamps you wish to enable by parameter 40 Sending data Archimede will automatically send to ArchimedeLINK all events and data of the procedure performed At the end of the procedure the display will show the measured weights If they are not the expected ones because tubes are not correctly placed and distort weight scale readings the blood components can be weighed again after correcting tubes position and the new weights can be sent to ArchimedeLI NKagain User Manual Version 1 15 Page 29 of 73 USING ARCHIMEDE Correct weights If you remove all the tubes and all the bags Archimede will automatically start a procedure of the same type You can force the process by pressing the button to continue with the same type of separation To go back to the procedures list page press y button I ncorrect weights Press one of the 6 key buttons below the display to weigh blood components again To accept the new values and send them to ArchimedeLI NK press Normal limits With ArchimedeLINK the normal limits check can be activated If it is enabled and the detected weights do not fall within the defined limits the display will show the blood components detected weights and the allowed l
57. meters 18 Insufficient erythrocytes amount Repeat procedure Defective HB sensor Call Authorized Service Center Obstructed filter Retry with a new bags set Tubes poorly positioned Relocate tubes Scales not calibrated Calibrate scales see scales calibration UNEXPECTED WEIGHT Cause 1 Remedy Cause 2 Remedy Scales weight has had a sudden variation due to an external agent Check that foreign objects are not on the scales and remove it Scales unstable Check if scales holder don t touch against metal plate Call Authorized Service Center BARCODE TOO LONG Cause 1 Remedy Cause 2 Remedy Barcode not compatible with the system The maximum possible length is 20 characters including the control character Read a compatible code Barcode reader set improperly Reconfigure barcode see Datalogic barcode configuration PROCEDURE HAS BEEN INTERRUPTED BY THE OPERATOR Cause 1 Remedy The operator has pressed STOR key button and confirmed interruption with key button Repeat procedure ERROR DI STANCE WEI GHT Cause 1 Remedy User Manual Version 1 15 The plate is in position where weight measured must be more Verify any obstructions that may create false weight readings Check bag setting parameters Page 63 of 73 Error 50 Error 52 Error 53 1 6 Error 54 Error 55 Error 56 1 4 Page 64 of 73 TROUBLESHOOTI NG ERRORE WEI GHT DI STANCE
58. nding to the value set in the procedure parameters 3 User Manual Version 1 15 Page 37 of 73 USING ARCHIMEDE If the automatic breaking cannula 45 is active the Archimedebreakes automatically the cannulas and starts the separation cycle it is available only if this optional is installed If the cannula breaking is active 2 the message Break cannulas will be displayed Break the cannulas by forcing on their side upper part and wait a few seconds for pressure reduction After detecting pressure decrease Archimede automatically starts the separation cycle If due to obstructions or tube kinks pressure circuit is not reduced below the threshold set it is any way possible to force the cycle start by pressing START key button If the cannula breaking is not active 2 Archimede automatically starts the cycle of separation The graphic interface will now show the current operating phase number and the weight value of plasma collected Archimede will check the buffy coat level through IR sensors flow valve and valves 2 3 and 4 The distance sensor will stop the separation process when the plate reaches the distance equivalent to buffy coat volume set in the parameters 18 After the plate will back if parameter 36 is set a quantity of plasma will be dispense by gravity in the Buffy Coat bag Now if parameter 20 is set the Red Cell Additive Solution is dispensed into RBC bag Air removal depends on procedure parameters 42 set
59. of its optical sensors The tube is correctly inserted when the clamp number is replaced by the icon D conty with tube control enable When all the bags and tubes are in position the text at the top right will be changed to START and the procedure start automatically Press START key button to start the procedure if the autostart doesn t happen If the primary bag expected weight check has been enabled through ArchimedeLINK and the measured weight does not fall within the defined limits a warning will be displayed showing both limits and current weight After verifying the cause of the problem confirm weight with or press y to leave the procedure Furthermore if the tube presence check is enabled the display will show the clamp numbers where tubes are not correctly inserted and the procedure will not start until all tubes are correctly inserted into the enabled clamps In also if a bags is not recognized an error will be displayed Now wait for the plate to get close to the bag The plate will apply a force corresponding to the value set in the procedure 3 User Manual Version 1 15 Page 43 of 73 USING ARCHIMEDE If the automatic breaking cannula 45 is active the Archimedebreakes automatically the cannulas and starts the separation cycle it is available only if this optional is installed If the cannula breaking is active 2 the message Break cannulas will be displayed Break the cannulas by forcing on their side
60. on the bag 3 on lateral weight scale Archimede checks correct tubes positioning inside proper clamps by means of its optical sensors The tube is correctly inserted when the clamp number is replaced by the icon Dony with tube control enable When all the bags and tubes are in position the text at the top right will be changed to START and the procedure start automatically Press START key button to start the procedure if the autostart doesn t happen If the primary bag expected weight check has been enabled through ArchimedeLINK and the measured weight does not fall within the defined limits a warning will be displayed showing both limits and current weight After verifying the cause of the problem confirm weight with or press y to leave the procedure Furthermore if the tube presence check is enabled the display will show the clamp numbers where tubes are not correctly inserted and the procedure will not start until all tubes are correctly inserted into the enabled clamps In also if a bags is not recognized an error will be displayed User Manual Version 1 15 Page 47 of 73 USING ARCHIMEDE Now wait for the plate to get close to the bag The plate will apply a force corresponding to the value set in the procedure parameters 3 If the automatic breaking cannula 45 is active the Archimedebreakes automatically the cannulas and starts the separation cycle it is available only if this optional is installed If the cannula bre
61. oning inside proper clamps by means of its optical sensors The tube is correctly inserted when the clamp number is replaced by the icon Daly with tube control enable When all the bags and tubes are in position the text at the top right will be changed to START and the procedure start automatically Press START key button to start the procedure if the autostart doesn t happen If the primary bag expected weight check has been enabled through ArchimedeLINK and the measured weight does not fall within the defined limits a warning will be displayed showing both limits and current weight After verifying the cause of the problem confirm weight with Or press y to leave the procedure Furthermore if the tube presence check is enabled the display will show the clamp numbers where tubes are not correctly inserted and the User Manual Version 1 15 Page 33 of 73 USING ARCHIMEDE procedure will not start until all tubes are correctly inserted into the enabled clamps In also if a bags is not recognized an error will be displayed Now wait for the plate to get close to the bag The plate will apply a force corresponding to the value set in the procedure parameters 3 If the automatic breaking cannula 45 is active the Archimedebreakes automatically the cannulas and starts the separation cycle it is available only if this optional is installed If the cannula breaking is active 2 the message Break cannulas will be displayed Break
62. op RBC with PPP PPP OBRWN EH SECONDARY TYPE NAME 5 Separation from PRP to PPP PLT 7 PLT residual BC with filter 8 Erythrocytes washing separation 12 PLT from single BC User Manual Version 1 15 Page 27 of 73 USING ARCHIMEDE 5 1 Questions This mode not available in stand alone mode allows complete procedures traceability With ArchimedeLI NK it is possible to define a series of questions to be asked soon after choosing the procedure to be used The replies will be checked according to various criteria length barcode type character type authorized operators IDs donors IDs bag lot validation There are two possible ways to set ArchimedeLINK e Manual association answer question Questions will be displayed with an arrow that indicates the code to read After reading the barcode the code will be display and the arrow will move to the next question e Auto association of answer question Question will be displayed without the arrow because the operator will read any of the codes desired and the system will recognize through the characteristics of the code what is the correct answer association So the operator can read in any sequence take the codes to be read In manual association if necessary you can read the answers by moving with the arrow keys K to select a target question while in automatic association just read again the code and it will be automatically reported in the right position Once the system h
63. procedure if the autostart doesn t happen If the primary bag expected weight check has been enabled through ArchimedeLINK and the measured weight does not fall within the defined limits a warning will be displayed showing both limits and current weight After verifying the cause of the problem confirm weight with or press A to leave the procedure Furthermore if the tube presence check is enabled the display will show the clamp numbers where tubes are not correctly inserted and the procedure will not start until all tubes are correctly inserted into the enabled clamps In also if a bags is not recognized an error will be displayed Now wait for the plate to get close to the bag The plate will apply a force corresponding to the value set in the procedure parameters 3 If the automatic breaking cannula 45 is active the Archimedebreakes automatically the cannulas and starts the separation cycle it is available only if this optional is installed If the cannula breaking is active 2 the message Break cannulas will be displayed Break the cannulas by forcing on their side upper part and wait a few seconds for pressure User Manual Version 1 15 Page 39 of 73 USING ARCHIMEDE reduction After detecting pressure decrease Archimede automatically starts the separation cycle If due to obstructions or tube kinks pressure circuit is not reduced below the threshold set it is any way possible to force the cycle start by press
64. r blood derivatives consistent with the International Standard ISO 3826 and with the 93 42 MDD regulation and following modifications 2007 47 EU of 21 03 2010 For optimum operation Archimede should be placed on a solid and stable surface away from direct heat sources Archimede as to be placed in such a way to permit at the Operator to switch it off and disconnect it from the electrical plug WARNING to avoid the risk of the shock hazard this device has to be exclusively connected with a plug with ground protection 1 2 Key features e User friendly interface e Graphic display of bags weight force and operation stages e Automatic delivery of Red Cell Additive Solution through press e Variable speed separation movement controlled by a stepper motor e Array of 18 optical sensors for Buffy Coat level check e Optical detector of RBC with electronic control of cover closure e Electronic control of the distance between plate and profile plate e Electronic control of the applied force with motor stop in case the safety limit is exceeded e Three weight scales with 2 Kg full scales and 1 g resolution e Six clamps four sealing head clamps one flow control clamp one normal clamp e Mechanical buffy coat separation system e Detection system of proper tubes positioning in each clamp e Can store up to 18 separation procedures with approx 40 parameters each e Self tare and auto calibration of the various measuring system
65. r information about technical service please contact local representative Any repair after the warranty period should be performed only by personnel instructed by qualified trainers Operator Manual Version 1 15 Page 3 of 73 MARKINGS Version Version Section PERE Section 2009 06 24 A Maltagliati Section Symbols 1 2 2 3 3 4 ERT 4 2 4 5 5 3 1 5 3 2 5 3 3 5 3 4 rane oo Re Sorel oa 5 5 1 5 3 12 5 313 760 Tel 912 2011 08 31 A Greggio Section 9 1 2 13 14 Symbol Do Section Symbols 1 12 3 0x 2011 09 27 I Milani Section 12 Sections 3 1 3 2 3 3 4 2 5 3 1 45 5 3 2 45 5 3 3 45 _x 5 3 4 45 5 3 5 45 5 3 6 45 1 14 3 XX 2012 03 26 A Maltagliati 5 3 7 45 5 3 8 45 5 3 9 45 5 3 10 45 5 3 11 45 8 2 E56 10 Sections 5 3 1 5 3 2 5 3 3 5 3 4 1 15 3 XX 2012 08 30 A Maltagliati 5 3 5 5 3 6 5 3 7 5 3 8 5 3 9 5 53 10 53 11 13 Page 4 of 73 User Manual Version 1 15 MARKINGS List of the symbols and marks used in this manual Class I Equipment in which protection against electrical shock does not rely on basic insulation only but which includes an additional safety precaution in the form of a means for the connection of the equipment to the protective earth conductor in the fixed wiring of the installation in such a way that accessible metal parts cannot become live in the event of a failure of the basic insulation EN 60601 1 Regulations
66. rchimedeLI NK Server Tube Sensors Check non presence of tubes and autocalibrate the sensors If the calibration values are out of limits an error will be sent and displayed If the problem persists consult the Troubleshooting section Same as in stand alone mode CSU Central Sealing Unit Check sealer unit If the CSU is not in the state of ready and detect the presence of moisture an error will be sent and displayed If the problem persists consult the Troubleshooting section Same as in stand alone mode CB system Cannula Breaker system Check cannula breaker system If the cannula breaker limit switches are not activated within the preset travel limits an error alarm will be sent and displayed If the problem persists please see the Troubleshooting section Same as in stand alone mode Plate motor Check of motor movement and limit switch If limit switches are not enabled within the preset travel limits an error alarm will be sent and displayed If the problem persists please see the Troubleshooting section Same as stand alone mode Force sensor Force sensor check If the force detected by the sensor is over the preset limits an error alarm will be sent and displayed If the problem persists please see the Troubleshooting section Same as stand alone mode Page 22 of 73 User Manual Version 1 15 USING ARCHIMEDE Buffy coat separation motor Check of motor movement and limit swit
67. removal depends on procedure parameters 42 setting Manual air removal put plasma bag in vertical position press START key button to open clamp 3 and remove air manually by pressing on the bag When finished press oso key button to close clamp 3 and re position plasma bag to detect weight The process will continue automatically Now remove tubes and bags and press START to continue with another separation of the same type or press to exit Page 36 of 73 User Manual Version 1 15 USING ARCHIMEDE 5 3 4PROCEDURE 4 Top amp Bottom quadruple PPP BC RCC This procedure is indicated for quadruple top amp bottom bags to obtain buffy coat BC erythrocytes RCC and two plasma PPP with one PPP for single buffy coat Separation Description iam fi Clamp 6 ne Clamp 4 Picture 18 Kit installation T B quadruple procedure Position bags and tubes according to the below sequence Be sure to avoid tensions and kinks that might cause flow obstruction or weighing errors Hang the primary bag on the bag holders on the front panel The label containing bag data should always be turned outside After detecting the primary bag the plate will move backward to make positioning of Red Cell Additive Solution bag easier and the display will show the bag icon Open cover of HB sensor and insert the tube coming from the primary bag into the reading area Close the cover and insert the plasma tube firmly into the flo
68. s connected to ArchimedeLI NK e Manual mode To speed up procedures selection the system can be configured to show only the procedures enabled In this way only the procedures most frequently used in the blood transfusion center will be displayed READ BAG TYPE if this icon is highlighted press the E button to see installed procedures list OR SELECT THE PROCEDURE va gt Using the arrows highlight the procedure you intend to use then press to start the procedure ENABLED PROCEDURES LIST 1 T amp T triple PPP or PRP RBC 2 T amp T quad PPP or PRP BC RBC 3 T amp B triple PPP BC RBC Picture 14 Enable procedures list Automatic mode Using ArchimedeLINK it is possible to associate a bag type to a procedure type In this way from the main menu you will only have to read the bag type barcode and ArchimedeLI NK will transmit to Archimede what type of procedure it has to run If information of a bag type is not sufficient to select the type of procedure other questions can be asked or you can select from a reduced list the procedures associated with that type bag in case they were more than one The separation procedures presently available are PRI MARY TYTE NAME T amp T triple PPP or PRP RBC T amp T quadruple PPP or PRP BC RBC Top amp Bottom triple PPP BC RCC Top amp Bottom quadruple PPP BC RCC Top amp Bottom triple PPP or PRP with BC 10 Cord separation 11 Aliquot separation 13 Top amp T
69. s of its optical sensors The tube is correctly inserted when the clamp number is replaced by the icon P only with tube control enable When all the bags and tubes are in position the text at the top right will be changed to START and the procedure start automatically Press START key button to start the procedure if the autostart doesn t happen If the primary bag expected weight check has been enabled through ArchimedeLINKand the measured weight does not fall within the defined limits a warning will be displayed showing both limits and current weight After verifying the cause of the problem confirm weight with or press y to leave the procedure Furthermore if the tube presence check is enabled the display will show the clamp numbers where tubes are not correctly inserted and the procedure will not start until all tubes are correctly inserted into the enabled clamps In also if a bags is not recognized an error will be displayed User Manual Version 1 15 Page 31 of 73 USING ARCHIMEDE Now wait for the plate to get close to the bag The plate will apply a force corresponding to the value set in the procedure parameters 3 If the automatic breaking cannula 45 is active the Archimedebreakes automatically the cannulas and starts the separation cycle it is available only if this optional is installed If the cannula breaking is active 2 the message Break cannulas will be displayed Break the cannulas by forcing on their
70. s via software The auto calibration functions are managed directly by ArchimedeLI NK e Can be used as a sealer and as a weight scale e Self diagnosis program to make the solution of technical problems easier e Bi directional data transmission via LAN and WLAN e PS2 port for barcode reader e Software update directly through PC e Built in clock and calendar for traceability of the ongoing procedure e Optional RFID reader e Optional 2D bar code reader able to read multiple bar codes in one shot Page 10 of 73 User Manual Version 1 15 INSTALLATI ON 2 INSTALLATION Archimede is a simple use highly versatile instrument allowing great automation It is supplied with preinstalled standard procedures that can be implemented and modified through ArchimedeLI NK Picture 1 Parts included in the packing Janel a sholder ler r Pi Calo mm a cD og x n rcable Jar 2 1 Unpacking Archimede Remove Archimede from its packing Take care not to break the load cells Check that no part is damaged Archimede is supplied with Side weight scale holders Magnetic filter holder Pacemakers and floppy disk must keep away at least of 10 cm WLAN antenna Support bar Power cable Barcode reader 2 2 Positioning Archimede e Environmental conditions may affect Archimede operation The following conditions Should therefore be avoided or minimized User Manual Version 1 15 Page 11 of 73 INSTALLATI ON e High t
71. sent of MOELCA s r l While the utmost care has been taken for collection and verification of the documentation contained in the present manual MOELCA s r l assumes limited responsibilities from its use MOELCA s r l assumes no responsibility for people or companies involved in the creation and issuing of the present manual Page 2 of 73 Operator Manual Version 1 14 WARRANTY MOELCA s r l certifies that the instrument is free from any defects when shipped from factory The warranty covers the instrument and all its parts for a period of 12 months from delivery date During the warranty period MOELCA s r l will repair or replace free of charge at its discretion and ex factory the parts or units that prove to be defective All parts or units replaced will become MOELCA s r l property The warranty is automatically voided in case of violations changes different use from that described in the instructions wrong plugging in power mains repairs performed by personnel not authorized by MOELCA s r l accidental breakings due to transportation or falls lack or deletion or modification of the serial number In case of repairs not covered by the warranty MOELCA s r l or its representatives will draw up a quotation and provide for repair upon written acceptance of the customer Service During the warranty period any repairshould be performed by personnel instructed by trainers The trainers have always to be qualified by MOELCA S r l Fo
72. st computer Power supply inlet including power socket On Off switch and fuse holder O Antenna for WLAN connection withArchimedeLI NK p LAN connector with yellow and green led Yellow led is Flashing in case of errors Off in normal condition Green led lit if there is Ethernet activity PS2 connector Allows connection of barcode reader Caution Consult accompanying documents according to the European Standard EN980 User Manual Version 1 15 Page 17 of 73 GENERAL DESCRIPTION 3 5 Keyboard Some of the keyboard key buttons are multi functions Ow A ARCHIMEDE pa 40666 ce Picture 7 Keyboard Allows to stop some functions and go back to the upper menu level Direction key buttons allow to move inside a menu and to change the value of the selected function Enter y gt oo cai 4 Allows to confirm the change or the selection Allows to start the separation procedure Allows to stop the ongoing procedure or application after confirmation Allows to select the displayed function Page 18 of 73 User Manual Version 1 15 GENERAL DESCRIPTION 3 6 Backlight Display The screen is a wide LCD 240 x 128 graphic display It is backlit to improve reading in low illuminated rooms 3 6 1Main Menu READ BAG TYPE This function allows to enter the menu to select the desired procedure OR SELECT The procedure can be selected manually by pressing key G or THE
73. t and unlit led Vtr lt 4500mV with I led gt 300 mA Remedy Clean IR sensors and yellow strip Cause 2 IR sensors pair is defective Remedy Call Authorized Service Center IR SENSOR SENSITIVITY TOO HIGH Cause 1 IR sensor detects too much difference between lit and unlit led Remedy Reduce environment luminosity Cause 2 IR sensors pair is defective Remedy Call Authorized Service Center HB SENSOR SENSITIVITY TOO LOW Cause 1 HB sensor does not detect sufficient variation between lit and unlit led Remedy Clean sensors Cause 2 Green sensors is defective Remedy Call Authorized Service Center HB SENSOR SENSITIVITY TOO HIGH Cause 1 HB sensor detects too high variation between lit and unlit led Remedy Call Authorized Service Center User Manual Version 1 15 Page 59 of 73 Error 21 Error 22 Error 23 Error 24 Error 25 Error 26 Error 27 Error 28 Page 60 of 73 TROUBLESHOOTI NG PLATE OPENI NG MOVI NG TI ME TO LI MIT POSITION gt 30 SECONDS Cause 1 Mechanical obstructions prevent the pressing plate from reaching open position Time gt 30 seconds Remedy Remove any obstruction Clean support bars Cause 2 Open position sensor defective Remedy Call Authorized Service Center PLATE CLOSI NG MOVI NG TI ME TO LI MIT POSITION gt 30 SECONDS Cause 1 Mechanical obstructions prevent the pressing plate from reaching close position Time gt 30 seconds Remedy Remove an
74. t the display area indicating current date Hi 00131 and time Press to enter modify mode l AN l Set date and time using keys s up and down key to increase or decrease value left and right to change the digit to modify and to confirm setting If you don t want to confirm the date and time change press key FORMAT READING 0 12 am pm dd mm yyyy 01 06 2011 mm dd yyyy 06 01 2011 yyyy mm dd 2011 06 01 Picture 10 Date and time format list Note If the Blood Transfusion Centre uses ArchimedeLINK date and time are automatically updated when the instrument is switched on or at the first connection of the day The PC date and time are the reference data Page 20 of 73 User Manual Version 1 15 USING ARCHIMEDE 4 USING ARCHI MEDE Using Archimede in separation mode is simple thanks to the built in microcontroller The microcontroller constantly checks the following parameters buffy coat level RBCs presence weights distance between plate and profile plate separation speed separation force maximum settable force correct program performance If connected to ArchimedeLINK Archimede sends all sensor and procedure data including those acquired by the barcode reader In stand alone mode data are store into a FIFO memory and should be sent automatically to ArchimedeLINK on next connection Archimede can store up to 300 procedure data before start to overwrite the oldest ones 4 1 Switching on While switching on the
75. te will apply a force corresponding to the value set in the procedure parameters 3 If the automatic breaking cannula 45 is active the Archimedebreakes automatically the cannulas and starts the separation cycle it is available only if this optional is installed User Manual Version 1 15 Page 41 of 73 USING ARCHIMEDE If the cannula breaking is active 2 the message Break cannulas will be displayed Break the cannulas by forcing on their side upper part and wait a few seconds for pressure reduction After detecting pressure decrease Archimede automatically starts the separation cycle If due to obstructions or tube kinks pressure circuit is n duced below the threshold set it is any way possible to force the cycle start by pressing key button If the cannula breaking is not active 2 Archimede automatically starts the cycle of separation The graphic interface will now show the current operating phase number and the weight value of PLT collected Archimede will check the flow and stop the plate in case of filter obstruction or RBC presence in the HB sensor In case of filter obstruction the operator can press START and continue until a new warning While in case of RBC presence if parameter 19 is set the system will asked if you want to end the procedure or continue in manual mode if 19 is disable the procedure will end automatically Air removal depends on procedure parameters 42 setting Manual air removal put pl
76. the cannulas by forcing on their side upper part and wait a few seconds for pressure reduction After detecting pressure decrease Archimede automatically starts the separation cycle If due to obstructions or tube kinks pressure circuit is not reduced below the threshold set it is anyway possible to force the cycle start by pressing START key button If the cannula breaking is not active 2 Archimede automatically starts the cycle of separation The graphic interface will now show the current operating phase number and the weight value of plasma collected Archimede press a plasma quantity in the bag of Buffy Coat equal to the value of the parameter 34 Afterwards if parameter 6 is active Archimede will check the erythrocytes level in the primary bag When this level reaches the selected IR sensor the display will show it in the area of the RBC pressing plate The photometric group that detects the presence of red blood cells will now in real time check the flow of blood components and when the concentration of red blood cells exceed the threshold set in parameter 8 the display show inside of sensor area RBC If is not active the dispensing of an excess of plasma 19 the plasma line will be closed and the buffy coat line will be opened When the buffy coat amount reaches the value set in the procedure parameter 22 the system will enable the mechanical separation group until the quantity of buffy coat set in the parameter 37 is reach
77. the values Now use the arrows to move the cursor to another option this will avoid performing another tare by pressing key button unintentionally Take the product you wish to weigh and hang it to the front or side weight scale or put it on the upper weight scale Weights are displayed in the following order Front scale Upper scale Side scale Picture 12 Reading weight scales area 4 5 Use as a Sealing unit Archimede can be used as a sealing unit thanks to its four built in sealing heads Press 6 key button below the sealing head that you wish to use or highlight the sealing head using the arrows Location of the sealing heads is as follows FERRE posi ERO 1 SEALING HEAD Picture 13 Archimede view To perform sealing with the selected sealing head press key button If you don t want to seal but you want to open or close the selected clamp press Sealing operation will be shown on left side of the clamp by the symbol 4 ek User Manual Version 1 15 Page 25 of 73 USING ARCHIMEDE In case any error occurs this will be displayed in the notice window of the screen e Clean sealing head the CSU has detected some moisture it is necessary to clean sealing head and tube and check for leakages e Insert tube the tube sensor has detected that the tube is missing or incorrectly inserted in the sealing head clamp e CSU busy the CSU is busy with a sealing cycle retry after a few seconds
78. ting Manual air removal put plasma bag in vertical position press START key button to open clamp 3 and remove air manually by pressing on the bag When finished press str key button to close clamp 3 and re position plasma bag to detect weight The process will continue automatically Now remove tubes and bags and press to continue with another separation of the same type or press to exit Page 38 of 73 User Manual Version 1 15 USING ARCHIMEDE 5 3 5PROCEDURE 5 Separation from PRP to PPP PLT This secondary procedure is to separate from PRP to result platelet poor plasma PPP and platelets concentrate Separation Description Picture 19 Kit installation procedure PRP to PPP PLT Position bags and tubes according to the below sequence Be sure to avoid tensions and kinks that might cause flow obstruction or weighing errors Hang the primary bag on the bag holders of the front panel The label containing bag data Should always be turned outside Insert the plasma tube firmly into clamp 3 Position the plasma bag on upper weight scale Archimede checks correct tubes positioning inside proper clamps by means of its optical sensors The tube is correctly inserted when the clamp number is replaced by the icon D ony with tube control enable When all the bags and tubes are in position the text at the top right will be changed to START and the procedure start automatically Press START key button to start the
79. to the bag The plate will apply a force corresponding to the value set in the procedure parameters 3 User Manual Version 1 15 Page 35 of 73 USING ARCHIMEDE If the automatic breaking cannula 45 is active the Archimedebreakes automatically the cannulas and starts the separation cycle it is available only if this optional is installed If the cannula breaking is active 2 the message Break cannulas will be displayed Break the cannulas by forcing on their side upper part and wait a few seconds for pressure reduction After detecting pressure decrease Archimede automatically starts the separation cycle If due to obstructions or tube kinks pressure circuit is not reduced below the threshold set it is any way possible to force the cycle start by pressing START key button If the cannula breaking is not active 2 Archimede automatically starts the cycle of separation The graphic interface will now show the current operating phase number and the weight value of plasma collected Archimede will check the buffy coat level through IR sensors flow valve and valves 3 and 4 The distance sensor will stop the separation process when the plate reaches the distance equivalent to buffy coat volume set in the parameters 18 After the plate will back if parameter 36 is set a quantity of plasma will be dispense by gravity in the Buffy Coat bag Now if parameter 20 is set the Red Cell Additive Solution is dispensed into RBC bag Air
80. upper part and wait a few seconds for pressure reduction After detecting pressure decrease Archimede automatically starts the separation cycle If due to obstructions or tube kinks pressure circuit is not reduced below the threshold set it is any way possible to force the cycle start by pressing START key button If the cannula breaking is not active 2 Archimede automatically starts the cycle of separation The graphic interface will now show the current operating phase number and the washing solution weight collected Archimede will check the erythrocytes level in the primary bag When this level reaches the IR sensor selected in 6 the clamp will be close with a delay equal to that set in parameter 26 Otherwise if the sensor HB in parameter 6 is flagged the display will show on the HB lid the reading RBC when erythrocyte are detected The plate will move backwards and a surnatant fall down by gravity with a quantity equal to that set in parameter 26 Now remove tubes and bags and press START to continue with another separation of the same type or press to exit Page 44 of 73 User Manual Version 1 15 USING ARCHIMEDE 5 3 8PROCEDURE 10 a UMBI LI CAL CORD This procedure is indicated for quadruple top amp bottom bag to obtain erythrocytes RCC plasma PPP and buffy coat BC diluted with plasma added through a press Separation Description Ageno RI r Picture 22 Kit installation procedure umbilical
81. usesRFenergyonlyforit RFemissions Group1 sinternal CISPR11 function Therefore itsRFemissionsareverylowand arenotlikelytocause anyinterferenceinnearby electronicequipment RFemissions ClassB TheModelArchimedeissuitableforuseinalle CISPR11 Stablishments l i includingdomesticestablishmentsandthos Harmonicemissions edirectly ClassA connectedtothepubliclow voltage IEC61000 3 2 Powersupply networkthatsupplies uildings usedfordomestic purposes Voltagefluctuations flickeremissions Complies Page 68 of 73 User Manual Version 1 15 Table 2 Guidanceandmanufacturer sdeclaration electromagneticimmunity TheArchimedeisintendedforuseintheelectromagneticenvironmentspecifiedbelow The customer ortheuseroftheArchimedeshouldassurethatitisusedinsuchanenvironment I MMUNI TYte st Electrostatic discharge ES D IEC61000 4 2 Electricalfast transient burst IEC61000 4 4 Surge IEC61000 4 5 Voltagedips sh ort interruptionsan d voltagevariations onpowersupp ly inputlines IEC61000 4 11 Powerfrequency 50 60Hz magneticfield IEC61000 4 8 IEC606 01 testlev el 6kVcontact 8kVair 2kVforpowe r supplylines 1kVforinput out put lines 1kVline s t o line s 2kVline s toearth lt 5 UT gt 95 dipinUT for0 5cycle 40 UT 60 dipinUT for5cycles 70 UT 30 dipinUT for25cycles lt 5 UT gt 95 dipinUT Compliancelevel 6kVcontact 8kVair 2kVforpowe r supplylines 1kVforinput out
82. w valve clamp 6 Insert the plasma tube coming from the flow valve firmly into clamp 3 Position the plasma bag on upper weight scales and i Insert the secondary plasma bag tube into clamp 2 Position the secondary plasma bag on upper weight scale Insert RBC tube into clamp 4 and position the RBC bag on lateral weight scale Archimede checks correct tubes positioning inside proper clamps by means of its optical sensors The tube is correctly inserted when the clamp number is replaced by the icon D only with tube control enable When all the bags and tubes are in position the text at the top right will be changed to START and the procedure start automatically Press START key button to start the procedure if the autostart doesn t happen If the primary bag expected weight check has been enabled through ArchimedeLINK and the measured weight does not fall within the defined limits a warning will be displayed showing both limits and current weight After verifying the cause of the problem confirm weight with Or press y to leave the procedure Furthermore if the tube presence check is enabled the display will show the clamp numbers where tubes are not correctly inserted and the procedure will not start until all tubes are correctly inserted into the enabled clamps In also if a bags is not recognized an error will be displayed Now wait for the plate to get close to the bag The plate will apply a force correspo
83. y obstruction Clean support bars Cause 2 Forcesensor defective Remedy Call Authorized Service Center BLADE MOVI NG TI ME TO LI MIT POSITION gt 10 SECONDS Cause 1 Mechanical obstructions prevent the buffy coat separator from reaching open or close position within 10 seconds Remedy Remove any obstruction Clean blade assy Cause 2 BC position sensor defective Remedy Call Authorized Service Center PLATE POSITIONING TIME TO HOME POSITION gt 30 SECONDS Cause 1 Mechanical obstructions prevent plate movement from reaching home position within 30 seconds Remedy Remove any obstruction Cause 2 Home position sensor defective Remedy Call Authorized Service Center POSITIONING TIME OF IR CALIBRATION POSITION SENSOR gt 10 SECONDS Cause 1 Mechanical obstructions prevent plate movement from reaching IR calibration position within 10 seconds Remedy Remove any obstruction Cause 2 IR calposition sensor defective Remedy Call Authorized Service Center PLATE ZERO POSITION SENSOR OVER RANGE Cause 1 Mechanical obstructions prevent plate movement from reaching zero position Remedy Remove any obstruction Cause 2 Distancesensor defective Remedy Call Authorized Service Center FORCE SENSOR HAS DETECTED STRESS gt 1 WITH PLATE FREE Cause 1 Mechanical obstructions prevent to correlate values between distance and force during self check Remedy Remove any obstruction Cause 2 Force sensor is

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