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StaRRsed Inversa User manual

1. utp Transmit Data a k a TxD Tx Sending data from DTE ut Outp Data Terminal Ready Raised by DTE when powered on In m auto answer mode raised only when RI arrives from DCE er ut Expects CTS from DCE Ring Indicator Set when incoming ring detected used for auto answer application DTE raised DTR to answer Null modem with loop back handshaking for DB 9 connectors The simple null modem cable without handshaking shows incompatibilities with common software The main problem with this cable is that there is a possibility for the software to hang if it checks the modem signal lines in a proper way l e with this null modem cable good written programs will perform worse than badly written programs To overcome this problem and still be able to use a cheap null modem communication cable with only three lines in it a fake null modem cable layout has been defined The null modem cable with loop back handshaking resulted from this Page 168 StaRRsed Inversa User manual Version 1 06 MRN 141 EN R mechatronics Appendix for StaRRsed Inversa DB 9 female 9jeura 6 ad NES gt Connector Comector2 Function 2 RD RXD SD TXD RXD sess A ELECTO DTR gt CD DSR RS RTS gt CS CTS RS RTS gt CS CTS The main purpose of this null modem cable is to let well defined software think there is handshaking available with a null modem cable which has no provisions
2. ESCAPE Enter the required password for the inserted type of service chip card and press ENTER Wait until the display shows CARD OK Page 94 StaRRsed Inversa User manual Version 1 06 MRN 141 EN mechatronics Quick start up 8 QUICK START UP This section describes a quick start up procedure and a general description of what to do before starting a large batch of samples to run through the system 8 1 Power up sequence Switch ON procedure e Switch the StaRRsed Inversa ON e Wait until the Main menu is visible on the display e The instrument is now ready 8 2 Check list The laboratory supervisor should check the following instrument settings and select the required options e Menu SETTINGS 30 MIN METHOD Default is OFF e Menu SETTINGS EDTA MODE Default is ON e Menu SETTINGS TCORR temperature correction Default is ON f 3 NOTE OG A small hardware modification is necessary to switch between EDTA mode and Citrate mode See work instruction WI 405 for details Check the following things before each large batch of samples Ensure that a chip card is present in the card reader This may be any type of chip card Open the printer and check if enough paper is available Replace if necessary Empty the waste container Check the liquid levels and refill the containers if necessary Pon StaRRsed Inversa User manual Page 95 Version 1 06 MRN 141 EN Re mechatronics Quick
3. StaRRsed Inversa User manual Version 1 06 MRN 141 EN R mechatronics Limit error ERROR see Limit error message Note See analyzer manual for more information about limit error settings Appendix for StaRRsed Inversa When a limit error occurs the fields for ESR 30 min ESR 60 min temperature corrected ESR and ESR 120 min are filled with spaces and thus results are not send to LIMS Together with the other data fields e g the sedimentation time the operator can see what caused the error and may or may not use the ESR values which are preserved in the limit error message Description of the limit error message L_err hhh www ttt ccc ddd e L err means limit error e hhhisthe 30 minutes ESR e WWW is the 60 minute ESR e ttt is the temperature corrected 60 minute ESR e ccc is the column height e dddis the 120 minute ESR if applicable Example of a limit error message without 30 minute ESR and 120 minute ESR L_err 123 89 200 StaRRsed Inversa User manual Page 161 Version 1 06 MRN 141 EN mechatronics Appendix Protocol MECHATRONICS 02 unidirectional 2 204 255 256 Appendix for StaRRsed Inversa STX Data 253 characters ETX of Position Data field Bytes Format Comment 1 Start of text 1 STX 2 Text distinction code 8 ESRRE Left aligned followed by spaces 10 Instrument ID 20 text If applicable 30 Sample ID 40 text 70 Reserve
4. Maintenance 15 MAINTENANCE The StaRRsed Inversa is an analyzer that operates with considerable amounts of whole blood virtually undiluted and stores it in a pipette for one hour For this reason instrument maintenance is of the utmost importance To maintain the maximum reliability of the instrument the maintenance procedures must be strictly followed All procedures are based on a number of samples Maintenance levels Work instruction Daily on page 121 WI 400 Daily on page 172 Weekly on page 121 WI 401 Weekly on page 173 Level 4 maintenance WI 404 Level 4 maintenance on page 179 on page 122 Level 3 Maintenance WI 403 Level 3 maintenance on page 177 Level 2 maintenance WI 402 Level 2 maintenance on page 175 Level 1 maintenance not available yet WARNING Always be aware of the danger of infection especially during maintenance Take appropriate precautions There is blood involved and therefore a BIO HAZARD The purpose of the daily maintenance is to keep the instrument clean and contamination as low as possible 15 1 Daily See work instruction WI 400 Daily on page 172 for a step by step procedure 15 2 Weekly The purpose of the weekly maintenance is to carry out the daily maintenance and additionally check for worn components See work instruction WI 401 Weekly on page 173 for a step by step procedure StaRRsed Inversa User manual Page 121 Version 1 06
5. When there is a column height error detected the software assumes that the pipettes is leaking and disables the future use of this pipette 16 4 2 Disabling a pipette If a pipette is leaking only slightly this may not be detected by the instrument Individual pipettes can be disabled manually for further use until they can be replaced e Note the number of the leaking pipette e Wait until the pipette is measured and empty e Go to Menu SETTINGS EN DISABLE PIPET and follow the instructions on page 54 Page 126 StaRRsed Inversa User manual Version 1 06 MRN 141 EN RW mechatronics Trouble shooting 16 4 3 Replacing a pipette NOTE Chip card type S is required NOTE nsi Make sure that all pipettes are empty and do not need to be measured e Goto Menu SERVICE REPLACE PIPET e Enter the number of the pipette to replace and press ENTER The pipette is turned to the door opening e Open the pipette cap and lift the pipette out Install the new pipette in the reversed order 16 5 Sampling not allowed now If no chip card is inserted in the card reader and the sample mode is started by pressing 1 Sample mode the following screen is shown Sample mode NOT ALLOWED NOW StaRRsed Inversa User manual Page 127 Version 1 06 MRN 141 EN R mechatronics Trouble shooting NO CARD PRESENT 2 ESCAPE e Press ESC to return to the main menu e Insert Q chip card or A to E chip
6. 7 5 2 2 12 Menu Protocol PROTOCOL No Serial Output E ESCAPE E SELECT A protocol is a set of rules governing the communication and the transfer of data between machines as in a computer system Also a formal set of rules and procedures to be followed during a request for information before data is transferred between machines and computer systems The following protocols can be selected for data transfer to the Laboratory data processor computer No Serial output MECHATRONICS 01 bidirectional on page 155 MECHATRONICS 02 unidirectional on page 163 Compact bidirectional on page 151 Compact unidirectional on page 147 oP com gt The protocol can be set in menu SETTINGS PROTOCOL After selecting a protocol save the new settings by pressing the ENTER key StaRRsed Inversa User manual Page 75 Version 1 06 MRN 141 EN R mechatronics User interface 7 5 2 2 13 Menu Baudrate BAUDRATE BAUDRATE 9600 ESCAPE p SELECT Use the ARROW DOWN or ARROW UP keys and select the required Baud rate 2400 4800 9600 19200 38400 8 N 1 Then press ENTER to save the new setting 7 5 2 2 14 Menu Checksum CHECKSUM NOT APPLICABLE E ESCAPE E SELECT Note This setting is only applicable if the output protocol is set to Compact unidirectional or Compact bidirectional Page 76 StaRRsed Inversa User manual Version 1 06 MRN 141 EN R m
7. l Text left aligned followed by spaces ASCII 20 xx number made up of xx digits 0 9 ASCIII 30 39 with leading zeros Leading zeros and non specified positions are filled with spaces ASCII 20 Page 150 mechatronics StaRRsed Inversa User manual Version 1 06 MRN 141 EN R mechatronics Appendix for StaRRsed Inversa Appendix Protocol Compact bi directional Bidirectional protocol definition of the sample request string from the StaRRsed Inversa to the Host computer Positions in the string 1 2 s 4 sje 7 8 jo ro rr 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 ESR Sample request string definition from StaRRsed Inversa to host computer Sm sejE sjR sjR se 12 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 SP RJSP cs em Definition of the string STX and ETX are at fixed position first 1 and last 31th position respectively SP Space character 20 E Capital letter E S Capital letter S R Capital letter R 1 18 Position of the sample identification left adjusted and filled up with spaces at the end of the string ds Checksum one char 00 FF that is the EXOR sum of all the data Data The position from position 2 up to and including position 29 Take position 2 and position 3 and EXOR those 2 Take the result and EXOR this with position 3 ect till the position 29 R At position 28 means that this is the Request string STX Cha
8. might be in sample tube e Needle unit malfunction Last prime more than 12 hours ago Last sample more than 12 hours ago Clean system Warning less than 5 credits left StaRRsed Inversa User manual Version 1 06 MRN 141 EN mechatronics Appendix for StaRRsed Inversa StaRRsed Inversa User manual Page 139 Version 1 06 MRN 141 EN mechatronics Appendix for StaRRsed Inversa Appendix Article reference list StaRRsed Inversa The StaRRsed Inversa is delivered with a complete accessories kit BANG119000 This reference list is for article order numbers only the actual contents of the accessories kit may be changed without notice BANGO010041 Drip plate basic BANGO20003 Plunger tip BANGO29004 Inversa Westergren pipette BANG030052 Pipette sealing ring BANG049002 Needle sealing block Dr O m U Co e N T D D D gt n QEPT080100 Thermal Roll 57 x 47 x 12 mm QWFG010300 Tap for Reagents container Teflon tip repair set 1 ring Disc filter 25mm White for waste container Oo UJ e al o al JJ 2 2 2 Q o n 2 D Q al lt G a eo e e O gt e gl x mk AN 2 lt S a e o o O 5 e m to x mk N co QEDK10002 QEDK130501 QWLVO30901 QWLV040001 QRR 010931 QRR 010946 Page 140 StaRRsed Inversa User manual Version 1 06 MRN 141 EN mechatronics Appendix for StaR
9. 112 F Facts and definitions 31 Fill errors during sampling 101 G General error procedure 123 General laboratory practices 31 H Hazy 181 Hazy reports 125 Host 181 Install at chosen location 23 INSTALLATION 21 INSTRUMENT DESCRIPTION 13 INTRODUCTION 9 INVERSA SYSTEM MESSAGES 117 IVD 181 L Lab Supervisor menu section 65 LABELS AND STICKERS 35 Leaking pipettes 125 Level 1 maintenance 122 Level 2 maintenance 122 Level 3 maintenance 122 Level 4 maintenance 121 122 Liquid levels and reagents preparation 97 Page 183 Index Main menu 43 MAINTENANCE 121 Medical requirements 31 Menu 2 Patient pos data 65 Menu 2 Patient pos data User 44 Menu 3 End of day wash 51 Menu 30 min method 69 Menu 30 minute output 77 Menu 4 Prime 53 Menu 5 Settings Lab Supervisor 68 Menu 5 Settings Service 84 Menu 5 Settings User 54 Menu 6 Service 56 89 Menu 6 Service Lab Supervisor 78 Menu 7 Card amp Credits 90 Menu 7 Card amp Credits User 59 Menu ACK NACK 77 Menu Barcode reader 87 Menu Baudrate 76 Menu Carousel position 71 Menu Checksum 76 Menu Clear error history 90 Menu Date 47 Menu Date Time 73 Menu Delete data 66 Menu Display S N 58 Menu DST 72 Menu EDTA mode 70 Menu Empty pipette 82 Menu En disable pipet 54 126 Menu Error history 56 Menu ESR time min 74 Menu Fa
10. 4 4 43 44 Number not assigned 4 If this error occurs repeatedly contact local service engineer Unknown status in rotate routine 6 If this error occurs repeatealy contact local service engineer E igned Number not assigned Number not assigned Number not assigned Unknown status in motor Reset the instrument If this error occurs repeatedly contact initialization routine local service engineer Error in motor initialization Reset the instrument If this error occurs repeatedly contact routine gt aborted local service engineer Filling motor timeout e Filling motor malfunction e Filling motor jammed Page 132 StaRRsed Inversa User manual Version 1 06 MRN 141 EN 2 5 47 48 49 50 Error in rotate routine gt aborted 52 mechatronics Appendix for StaRRsed Inversa Needle motor or sensor malfunction Needle motor jammed Carrousel motor or sensor malfunction Carrousel jammed Gripper motor or sensor malfunction Gripper jammed Measuring motor or sensor malfunction Measure head jammed Nozzle motor timeout e Nozzle motor or sensor malfunction e Nozzle jammed Power supply current trip e Check power supply Unknown status in protocol If this error occurs repeatedly contact routine local service engineer No host response after e Check protocol settings sending request Check LIMS settings e Check connection between Inversa and LIMS No hos
11. Appendix Article reference list StaRRsed Inversa 20 140 Appendix Configuration barcode readers 170 Appendix Error list StaRRsed Inversa 130 Appendix Factory default settings StaRRsed Inversa 143 Appendix Maintenance schedule StaRRsed Inversa 145 Appendix Protocol Compact bi directional 75 108 151 Appendix Protocol MECHATRONICS 01 bidirectional 75 108 155 Appendix Protocol MECHATRONICS 02 unidirectional 75 108 163 Appendix RS 232 DB9 pins female hardware back panel connector 119 168 Appendix String format for StaRRsed 75 107 108 147 Appendix Tube connection StaRRsed Inversa 141 Appendix Warning list StaRRsed Inversa 138 APPENDIX FOR STARRSED INVERSA 129 Aspect Hazy 114 Aspirating the sample 100 Automatic rinsing of the sample system 101 Basics of Bio safety 29 Bidirectional 181 C CE Mark StaRRsed Inversa 20 Check list 95 Chip card system 15 Chip card type A to E 16 Chip card type Q 16 Chip card type S 16 StaRRsed Inversa User manual Version 1 06 MRN 141 EN Index Chip card type T 16 Citrate mode 181 Column height 126 D Daily 121 DATA MANAGEMENT 119 Diluent QRR 010931 35 98 Dilution principle 10 Disabling a pipette 126 Document history overview 3 E E C Declaration StaRRsed Compact 34 EDTA mode 181 End of day wash procedure 103 ESR 181 Explanation of the error messages
12. EL dp Een Mee 6 so 100 150 200 pipet bottom sedimentation 110mm Graphic showing typical absorption values of a sample 250 column height Page 114 StaRRsed Inversa User manual Version 1 06 MRN 141 EN R mechatronics Reporting The sedimentation value is the distance in millimeters between the cells plasma level 87 5 absorption and the meniscus If there ins no haze the absorption drops quickly to a value below the 75 level If the distance between the 87 5 and the 75 level is less then 3mm the report will state CLEAR If the distance between 87 5 and 75 level is more than 3mm then the report will state HAZY Depending on the length of the hazy area three classes of hazyness are reported Length of Reported area class Hazy area area Hazyarea gt 25mm 25mm Hazy gt 25mm Hazy gt 25mm mm Hazy reports are shown when the change from the hazy level to the cell plasma separation level occurs not within a given distance The following bands are reported in the aspect column of number 5 12 2 6 1 Analyser HAZY code messages This code appears in the sample data record at line A The following 4 codes are defined 0 Sample is clear Sample is Hazy lt 10 1 2 Sample is Hazy 25 3 Sample is Hazy 25 StaRRsed Inversa User manual Page 115 Version 1 06 MRN 141 EN R mechatronics Inversa system messages 13 INVERSA SYSTEM
13. ESCAPE E SELECT Select 1 LOAD CREDITS This function is used to load credit units from a credit chip card into the internal memory of the StaRRsed Inversa LOAD CREDITS CONTINUE E ESCAPE Press ENTER to start the function LOAD CREDITS Do NOT REMOVE CARD BUSY PLEASE WAIT Es ESCAPE Page 60 StaRRsed Inversa User manual Version 1 06 MRN 141 EN mechatronics User interface DONE TYPE Q Note This is the code letter for the type of chip card SN 123456789 Note This is the serial number of the chip card CREDITS XXXXXXX Note This is the total amount of available credit units in memory gt ESCAPE StaRRsed Inversa User manual Page 61 Version 1 06 MRN 141 EN mechatronics User interface 7 5 1 8 2 Menu Read service card Make sure you insert a service chip card type in the chip card reader of the StaRRsed Inversa LOAD CREDITS READ SERVICE CARD ESCAPE pm SELECT Select 2 READ SERVICE CARD This function is used to unlock the protected menus and functions READ SERVICE CARD CONTINUE TT Escape Press ENTER to start the function READ SERVICE CARD Do NOT REMOVE CARD BUSY PLEASE WAIT ESCAPE Page 62 StaRRsed Inversa User manual Version 1 06 MRN 141 EN R mechatronics User interface READ SERVICE CARD TYPE S Note This is the code letter for the type of chip
14. Inversa User manual Page 79 Version 1 06 MRN 141 EN mechatronics User interface 7 5 2 3 2 Menu Valve control Noz NpL V23 DIL CLN V23 VENTING V25 BLOOD V26 DILUTER V27 ESCAPE EE SELECT These functions can be used to test the function of the valves for service and maintenance reasons Select the required valve and use the ARROW DOWN or ARROW UP keys to switch the valve ON or OFF A 7 5 2 3 3 Menu Sensor status SENSOR STATUS BLOOD DETEC 154 MEAS HEAD 40 TEMPERATURE 20 C POS SENSOR 235 WASTE SENSOR 154 ESCAPE Note Waste sensor Empty waste bottle gt 120 Full waste bottle 87 5 No waste bottle present 30 Page 80 StaRRsed Inversa User manual Version 1 06 MRN 141 EN User interface R mechatronics 7 5 2 3 4 Menu Measure pipette MEASURE PIPET 3 ESCAPE Press the ENTER key to measure the pipette that is currently in front of the measure unit The result is printed on the build in printer 7 5 2 3 5 Menu Read barcode READ BARCODE BARCODE 1234567890 2 ESCAPE To check the function of the barcode reader place a sample tube with barcode in the needle unit and press the ENTER key The detected barcode is displayed on the screen in this example 1234567890 Page 81 StaRRsed Inversa User manual Version 1 06 MRN 141 EN R mechatronics User interface 7 5 2 3 6
15. MESSAGES 13 1 System messages During normal operation the following system messages may occur 1 Waiting tube e Ifa filled pipette is at the measuring position before the elapsed time has finished and the operator is ready to fill the next pipette the waiting tube message will be displayed e To continue the sample loading sequence the operator must wait until the pipette at the measuring position has been measured 2 Printer failure e Check paper quantity e Note data will be stored in the buffer and can be printed afterwards 3 Reagents level empty message e All reagent bottles have level detectors the display shows an error that indicates which reagent bottle s is are empty e Prepare new reagent as described in section Quick start up 4 Waste bottle full message or No waste bottle message e The waste container also has a level detector If a waste error is shown on the display the StaRRsed Inversa will stop filling and cleaning pipettes until a new or empty container has been installed e Empty the waste container and press ESC to clear the error StaRRsed Inversa User manual Page 117 Version 1 06 MRN 141 EN R mechatronics Data management 14 DATA MANAGEMENT All data in the StaRRsed Inversa is stored in a battery back up memory Therefore important data is kept irrespective of a power failure or if the instrument is unintentionally turned off When switched on the StaRRsed Inversa wi
16. Menu Max needle current MAX NEEDLE CURRENT CURRENT 180 INPUT E ESCAPE StaRRsed Inversa User manual Page 87 Version 1 06 MRN 141 EN mechatronics User interface 7 5 3 1 6 Menu Factory settings FACTORY SETTINGS ARE YOU SURE ESCAPE The StaRRsed Inversa is reset to the factory default settings Page 88 StaRRsed Inversa User manual Version 1 06 MRN 141 EN Ri mechatronics 7 5 3 2 Menu 6 Service ERROR HISTORY SOFTWARE VERSIONS DISPLAY S N 2 3 4 5 6 7 NEXT ESCAPE SELECT Next MOTOR CONTROL VALVE CONTROL SENSOR STATUS MEASURE PIPET READ BARCODE REPLACE PIPET NEXT L1 ESCAPE Next EMPTY PIPET L1 ESCAPE StaRRsed Inversa User manual Version 1 06 MRN 141 EN User interface Page 89 mechatronics User interface 7 5 3 2 1 Menu Clear error history CLEAR ERROR HISTORY ARE YOU SURE Fr ESCAPE mE SELECT JE 7 5 3 3 Menu 7 Card amp Credits LOAD CREDITS READ SERVICE CARD TRANSFER CREDITS RESET SERV COUNTER SET D FACTOR ES ESCAPE MP SELECT Page 90 StaRRsed Inversa User manual Version 1 06 MRN 141 EN mechatronics User interface 7 5 3 3 1 Menu Load credits LOAD CREDITS READ SERVICE CARD E ESCAPE E SELECT Select 1 LOAD CREDITS This function is used to load credit units from a credit chip card into the internal memory of t
17. card SN 123456789 Note This is the serial number of the chip card PASSWORD XXXX Note type the required password for this service chip card ESCAPE Enter the required password for the inserted type of service chip card and press ENTER Wait until the display shows CARD OK StaRRsed Inversa User manual Page 63 Version 1 06 MRN 141 EN RS mechatronics User interface 7 5 2 Lab Supervisor menu section Lab Supervisor functionality can be accessed with chip card type S Only the additional supervisor functions and submenus are explained in this section For the standard user menu refer to the User menu section on page 43 7 5 2 1 Menu 2 Patient pos data is T PATIENT DATA POSITION DATA PRINT DATA PRINT RAW DATA SEND DATA a a a aA rm dp DELETE DATA m rh SELECT i i guns ESCAPE StaRRsed Inversa User manual Page 65 Version 1 06 MRN 141 EN mechatronics User interface 7 5 2 1 1 Menu Delete data DELETE PIPET DATA DELETE HIST DATA gt ESCAPE Function 1 DELETE PIPET DATA is used to delete all data of samples currently in the pipettes These samples have not been measured yet Function 2 DELETE HIST DATA is used to delete all stored data results of previously measured samples Warning Using these functions will erase all of the selected data from the memory of the StaRRsed Inversa Once erased the data can not be re
18. chip card system which makes it possible to employ the instrument either in a pay per test scheme or on customer owner basis Specific types of chip cards also grant access to specific instruments settings A chip card must always be present in the card reader to operate the instrument The card reader is located on the left side of the StaRRsed Inversa Insert the chip card into the card reader with the printed side facing forward The chip card is correctly inserted when it appears as shown in the picture StaRRsed Inversa User manual Page 15 Version 1 06 MRN 141 EN mechatronics Instrument description 2 1 1 Chip card type Ato E Chip cards of the types A to E are used to operate the instrument in a pay per test scheme The chip cards contain a certain amount of credits units How many tests can be performed with this amount of credits depends on the configuration which is made by the local StaRRsed Inversa dealer The following amounts of credit units are available Card type 100 000 A 8 500 1 000 000 EE 5 000 000 10 000 000 CN NOTE nsi Available card types and amount of credit units per card may be subject to changes The total amount of credit units on the chip card is transferred to the StaRRsed Inversa at once and the chip card is then rendered void It is not possible to use the same chip card to transfer credits to more than one instrument This type of card is dealer dependent The instrume
19. computer systems The following protocols can be selected for data transfer to the Laboratory data processor computer No Serial output MECHATRONICS 01 bidirectional on page 155 MECHATRONICS 02 unidirectional on page 163 Compact bidirectional on page 151 Compact unidirectional on page 147 oP oN gt The protocol can be set in menu SETTINGS PROTOCOL After selecting a protocol save the new settings by pressing the ENTER key 12 2 Result Printout The results of the ESR measurements are send to the built in printer and printed on thermal paper The layout of the report depends on the selection of the 60 or 30 minute method CN NOTE v ndi Thermal paper is sensitive to light and printouts will start to fade after several weeks If you need to retain the printed reports for future reference store the printouts in a cool dark place or make copies on a regular copy machine NOTE The descriptions Line 1 to Line D in the following subsections are only for reference within this documentation These descriptions do not appear on the printout Which lines are actually displayed on the printout depends on the instrument settings and the printed result Page 108 StaRRsed Inversa User manual Version 1 06 MRN 141 EN mechatronics Reporting 12 2 1 Report 60 Minute mode Column 1 Column 2 Column 3 Column 4 Line B EDTA ON ESR time 60 Line C 15 03 10 13 01 23 C P15 Patient number 1
20. indicate the computer system and associated software LIMS that provides the sample management for the laboratory I 19 1 1 1 7 IVD IVD is short for In Vitro Diagnostic This kind of diagnostic is performed on biological samples in a test tube or more generally in a controlled environment outside a living organism n vitro means in glass in Latin M 19 1 1 1 8 MRN MRN is short for Master Registration Number It is used as an identification number for any manual for Mechatronics products T 19 1 1 1 9 The sedimentation of blood cells is a temperature dependent process To achieve comparable results temperature correction should always be used The ESR results are then corrected to the value they would have been at the standard temperature of 18 3 TC Temperature correction Page 181 Glossary of Terms U 19 1 1 1 10 Unidirectional Unidirectional communication means that there is only one way communication from the StaRRsed Inversa to the HOST Only sample results and result related messages are send W 19 1 1 1 11 WI WI is short for Work Instruction and is used with an index number for a range of work instructions Page 182 R mechatronics StaRRsed Inversa User manual Version 1 06 MRN 141 EN mechatronics 20 INDEX A Aborting the sample sequence 101 About this manual 10 Accessories kit 20 Analyser 115 Analyser ERROR 111 Analyzers Error code messages 111
21. of 1 Purpose Level 4 maintenance Safety Bio Hazard area Instrument StaRRsed Inversa Revision Draft September 2010 NOTE Chip card type S is required Prepare disinfectant if not already prepared 180 Add 10 ml bleach sodium hypochlorite to 190 ml de ionized water 5 solution This disinfectant is for cleaning of all external parts that are exposed to blood 1 Wipe the lower tube holder of the needle unit 2 Wipe the stainless steel drip plates below the pipette carousel and needle unit e In the Main menu use the function END OF DAY WASH Check the system for leakage 5 Inspect sample needle condition Menu SERVICE MOTOR CONTROL NEEDLE M31 Press ARROW DOWN twice to expose the needle tip If the tips are worn replace the needle assembly StaRRsed Inversa User manual Page 179 Version 1 06 MRN 141 EN Rm mechetronics Work instruction StaRRsed Inversa 6 Check the waste pump tube condition Replace the tube if it appears worn or leaking Page 180 StaRRsed Inversa User manual Version 1 06 MRN 141 EN mechatronics 19 GLOSSARY OF TERMS B 19 1 1 1 1 Bidirectional communication means that there is two way communication from the StaRRsed Inversa to the HOST sample requests and results and from the HOST to the StaRRsed Inversa confirmation or denial of sample requests C 19 1 1 1 2 Citrate mode is used for pre diluted samples collected in tube
22. start up 8 3 Printer paper replacement When a red line appears across the length of the printout the printer paper roll is approaching its end The remaining paper is sufficient for ca 24 printed reports The red line marker is getting more intense as it comes closer to the end of the paper roll To open the printer pull the handle at the top of the flap Insert a new paper roll as shown Page 96 StaRRsed Inversa User manual Version 1 06 MRN 141 EN RS mechatronics Quick start up 8 4 Liquid levels and reagents preparation The liquid levels on the StaRRsed Inversa are automatically checked by sensors To avoid level sensor alarms during routine operation the liquid levels in the containers should also be checked visually every day NOTE a Refill reagent as soon as possible when the level sensor alarm appears 1 Reagents preparation e Use only the reagent containers which are supplied with the StaRRsed Inversa e To open the bulk reagent packages remove the perforated flap from the cardboard box pull the opening out of the box and fit the taps 2 Fill up the containers with the reagents 3 To remove the containers from the instrument first pull the slider all the way up then remove the bottle StaRRsed Inversa User manual Page 97 Version 1 06 MRN 141 EN mechatronics Quick start up 8 4 1 Diluent QRR 010931 Sodium citrate diluent is used for the dilution of undiluted EDTA samples and for th
23. string sum ASCII string sum the ASCII sum of all preceding characters incl stx cr If and ext modulo 256 ASCII string sum the remainder of the ASCII string sum when divided by 256 ow m o O s Ppeemme vw a StaRRsed Inversa User manual Page 147 Version 1 06 MRN 141 EN mechatronics Appendix for StaRRsed Inversa Page 148 StaRRsed Inversa User manual Version 1 06 MRN 141 EN mechatronics Appendix for StaRRsed Inversa ESR string format for StaRRsed 30 minutes format stx PPPPPPPPPP hhh www WWW AAAAAAAAAmm ppp TTT CC EEEEEEEEEEEEEEEEEEEEEE MMMMMMMMMM cr 1f eot stx 80 data characters cr If eot Checksum OFF 30 min 80 data characters eot Checksum ON 30 min Data consists if 30 min output is switched to ON Position Description 10 Patient identification text P hhh 4 E S R in mm Half hour method m po I lt E S R in mm 60 min corrected for temp Aspect AAAAAAAAA Manually added code Pipette number ox mm xx ppp Sedimentation time u EA Ton Temperature in degree Default C Error messages Text EEEEEEEEEEEEEEEEEEEEEE EDTA message MMMMMMMMMM ASCII STX ASCII 02 ETX ASCII 03 StaRRsed Inversa User manual Page 149 Version 1 06 MRN 141 EN ES 16 te m 2 24 32 EE sr 3 s ps 45 46 Eg Pres Appendix for StaRRsed Inversa ew
24. um ESCAPE mE SELECT CET Next submenu 1 PROTOCOL y 2 BAUDRATE y Page 84 StaRRsed Inversa User manual Version 1 06 MRN 141 EN Ri mechatronics User interface 3 y 4 CHECKSUM y 5 ACKINACK y 6 __ 30 MINUTE OUTPUT y V7 NEXT I SELECT Next submenu SET PISTON POSITION SET BLOOD SENSOR SET WASTE SENSOR BARCODE READER MAX NEEDLE CURRENT NEXT rx L1 ESCAPE SELECT Next submenu FACTORY SETTINGS CR L1 ESCAPE nm A SELECT To return to the previous settings screen press ESC To return directly to the Main menu keep ESC pressed until the Main menu is displayed StaRRsed Inversa User manual Version 1 06 MRN 141 EN Page 85 mechatronics User interface 7 5 3 1 1 Menu Set piston position SET PISTON POSITION POSITION 898 898 EP MOVE PISTON 2 ESCAPE 7 5 3 1 2 Menu Set blood sensor SET BLOOD SENSOR BLOOD DETEC 125 ESCAPE 7 5 3 1 3 Menu Set waste sensor SET WASTE SENSOR WASTE SENSOR 125 2 ESCAPE Note Empty waste bottle 2120 Full waste bottle 87 5 No bottle 30 Page 86 StaRRsed Inversa User manual Version 1 06 MRN 141 EN R mechatronics User interface 7 5 3 1 4 Menu Barcode reader BARCODE READER BARCODE READER Keyence ESCAPE mp SELECT Make here the selection between the barcode reader type Opticon or Keyence 7 5 3 1 5
25. 1 ERROR 18 Ss ESCAPE Tug SELECT The first row shows the current date and time The third row shows the date and time when the displayed error occurred Use the ARROW DOWN or ARROW UP keys and select the next error code 7 5 1 7 1 2 Menu Print error history PRINT ERROR HISTORY CONTINUE E Escape a Press ENTER to start the function The error history is printed on the build in printer StaRRsed Inversa User manual Page 57 Version 1 06 MRN 141 EN R mechatronics User interface 7 5 1 7 2 Menu Software versions SOFTWARE VERSIONS MAIN V1 21 SLAVE IO V1 11 DISPLAY V2 11 3 ESCAPE 7 5 1 7 3 Menu Display S N DISPLAY S N S N 000123456789 Es ESCAPE The displayed number is the instrument security number which is a security feature associated with the chip card system N NOTE an This security number is not the same as the serial number of the instrument The serial number is printed on the instrument type label on the back of the StaRRsed Inversa Page 58 StaRRsed Inversa User manual Version 1 06 MRN 141 EN mechatronics User interface 7 5 1 8 Menu 7 Card amp Credits User LOAD CREDITS READ SERVICE CARD E cs ESCAPE DW SELECT StaRRsed Inversa User manual Page 59 Version 1 06 MRN 141 EN mechatronics User interface 7 5 1 8 1 Menu Load credits LOAD CREDITS READ SERVICE CARD E
26. 181 20 INDEX C 183 StaRRsed Inversa User manual Page 7 Version 1 06 MRN 141 EN mechatronics 1 Introduction INTRODUCTION The StaRRsed Blood Sedimentation Rate Instrument hereafter called StaRRsed Inversa is an in vitro diagnostic medical device that automatically carries out the erythrocyte sedimentation rate analysis according to the Westergren method using closed sample tubes filled with citrate or EDTA blood The StaRRsed Inversa is an advanced ESR system that offers many unique features and benefits over the traditional ESR procedures Automating this method has the following advantages The Westergren pipettes are always filled to the correct level Using closed sample tubes reduces the possibility of contamination for the user and environment Standard glass Westergren pipettes are used in which the measurement can be corrected to a constant temperature 18 C Celsius Even small abnormalities can be detected over a longer period of time irrespective of where and when the blood sample was taken Every sedimentation measurement is directly linked to an identified sample so that a manual work sheet is unnecessary Patient ID errors are reduced to a minimum by using the bar code reader In the EDTA mode the accuracy of dilution of EDTA blood with citrate is considerably better than manual dilution achieved either by tipping off or using evacuated blood collection tubes pre filled with citrate solution
27. 234567890 Line 1 ID 1234567890 60 minute ESR result in millimeters corrected for 18 C only in use if temperature correction is active Line 2 ESR T corr 75 mm 1H Not corrected 60 minute ESR result Line 3 ESR 60 84 mm 1H Aspect clear hazy Line A Aspect Clear EDTA mode is On or OFF Line B EDTA ON ESR time 60 StaRRsed Inversa User manual Page 109 Version 1 06 MRN 141 EN Reporting ESR TIME Actual sedimentation time in minutes Line C 15 03 10 13 01 22 C The present Present date us temperature mechatronics P15 Pipette number in this example pipette 15 Line D is used for error and warning messages and printed in reversed colours 12 2 2 Report 30 Minute mode Column 1 Column 2 Column 3 Column 4 Line 3 ESR 60 84 mm ih Line 4 ESR 30 42 mm h Line A Aspect Clear Line B EDTA ON ESR time 30 Line E 15 03 10 13 01 23 C P15 Line D Patient number Line 1 ID 1234567890 60 minute ESR result in millimeters corrected for 18 C only in use if temperature correction is active Line 2 ESR T corr Page 110 75 mm 1H StaRRsed Inversa User manual Version 1 06 MRN 141 EN R mechatronics Reporting Not corrected 60 minute ESR result Line 3 ESR 60 84 mm 1h Not corrected 30 minute ESR result only in use if 30 minute mode is active Line4 ESR 30 42 mm h Aspect clear hazy Line A Aspect Clear EDTA mode is On or OFF LineB EDTA ON
28. ABELS AND STICKEHS esee nannten toncu ttu inen ex b anus tiii ss aaaea UN RU EE D exces 35 5 1 Stickers for the onboard reagents DottlesS ooooonniccnnccccnnnncccnncccocccccnncncnannnannnnnos 35 5 2 Stickers of the reagents containers ooooonnoccccnnnncocnnononcncnnnnnnnncnannnnnnnnnnnnnnnnnnnnnnncnnos 35 6 SAFETY cem 37 7 USER UN CE une ice 39 7 1 Navigating through the menlis a anna 40 A PP 41 7 2 1 Start Printout after Switch ON ea 41 73 Warning screen Prime ss 42 7 4 Warning screen End of day wash uuuussssssnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn nenn 43 7 5 Menu structure StaRRsed Inversa ivi 43 StaRRsed Inversa User manual Page 5 Version 1 06 MRN 141 EN Contents 7 5 1 User menu section Main menu Sample screen Menu 2 Patient pos data User Menu 3 End of day wash Menu 4 Prime Menu 5 Settings User Menu 6 Service Menu 7 Card amp Credits User 7 5 2 Lab Supervisor menu sect 7 5 2 1 Menu 2 Patient pos data 7 5 2 2 Menu 5 Settings Lab Supervisor 7 5 2 3 Menu 6 Service Lab Supervisor 7 5 3 Service menu section 7 5 3 1 Menu 5 Settings Service 7 5 3 2 Menu 6 Service 7 5 3 3 Menu 7 Card amp Credits 8 QUICK START UP 8 1 Power up sequence 8 2 Check IST ee 8 3 Printer paper replacement 8 4 Liquid levels and reagents preparation 8 4 1 Diluent QRR 010931 8 4 2 X Clean QRR 010946 8 5 Priming the fluid system 9 SAMPLE ROUTINE PROCEDURE 9 1 Sample M
29. D manually as described in the next section NOTE Bi The sampling may not start immediately if a clean pipette is not yet available but will start automatically when a clean pipette is available within 90 sec To prevent the aspiration of a not properly mixed sample sampling will not start automatically when it takes longer than 90 sec for a pipette to become available The operator must then remix the sample and push the START key again 9 2 2 Sample tubes without barcode If the sample tube has no barcode or the barcode can not be read you can enter the sample ID manually 1 Start the SAMPLE MODE 2 Enter the ID number 3 Push the START key CN NOTE e a The sampling may not start immediately if a clean pipette is not yet available but will start automatically when a clean pipette is available within 90 sec To prevent the aspiration of a not properly mixed sample sampling will not start automatically when it takes longer than 90 sec for a pipette to become available The operator must then remix the sample and push the START key again 9 3 Aspirating the sample When a clean pipette is available the needle assembly goes down and pushes the sample tube over the needles The necessary blood volume is drawn from the sample tube into a tube T3 until the blood sensor is triggered When the blood sensor is triggered the piston of the Westergren pipette is pulled up to aspirate the sample into the pip
30. ESRtime 30 ESR TIME Actual sedimentation time in minutes Line C 15 03 10 13 01 22 C P15 Pipette number in The present Present p date Present time temperature this example pipette 15 Line D is used for error and warning messages and printed in reversed colours 12 2 3 Analyser ERROR Error messages can be found on the printout at the bottom line in reversed colours All other lines of the report are removed accept the line with patient ID and line B and C If errors are found during the measurement the StaRRsed Inversa will give an audible alarm 12 2 3 1 Analyzers Error code messages Analyzers ERROR code messages This code appears in the sample data record at column 10 The following codes are defined StaRRsed Inversa User manual Page 111 Version 1 06 MRN 141 EN Reporting O NOERRORS 1 No cells plasma found ERROR 2 ESR Probably gt 140 mm ERROR 3 Too many borders found ERROR 4 Column height nnn WARNING 5 Measure error WARNING 6 Bubbles on top WARNING 7 Limit error ERROR 12 2 3 2 Explanation of the error messages No cells plasma found ERROR No contents could be detected in the pipette ESR Probably 140 mm ERROR Extremely high ESR value Too many borders found ERROR mechatronics More than three borders found possibly air bubbles See Section Trouble shooting Air bubbles Column height nnn WARNING Column h
31. MRN 141 EN mechatronics Maintenance 15 3 Level 4 maintenance The purpose of level 4 maintenance is to carry out the daily and the weekly maintenance Check the waste pump tube condition Replace the tube if it appears worn or leaking See work instruction WI 402 Level 4 maintenance on page 175 for a step by step procedure 15 4 Level 3 maintenance 15 5 Level 2 maintenance 15 6 Level 1 maintenance Not available yet Page 122 StaRRsed Inversa User manual Version 1 06 MRN 141 EN mechatronics Trouble shooting 16 TROUBLE SHOOTING Occasionally small faults may cause major problems This chapter may help to solve the most common faults and explain why a specific problem occurs A lot of the problems or errors are due to a lack of maintenance Remember that this instrument operates with a considerable amount of whole blood virtually undiluted stores it in a pipette for one hour and then cleans pipettes for re use Therefore it is important to keep to the maintenance schedules It is recommended that trained service personnel checks and applies service to the instrument at least once a year 16 1 General error procedure Whenever an error occurs follow the instructions given in the Error list If no instructions are given follow this general procedure 1 Clear the error by pressing the ESC key 2 When the error is not cleared or the error occurs again 3 Switch the StaRRsed Inversa OFF 4 Sw
32. Menu Replace pipette REPLACE PIPET CURRENT POS 8 INPUT ESCAPE This function can be used to move a particular pipette to the door opening when the pipette needs to be replaced Enter the number of the pipette and press ENTER 7 5 2 3 7 Menu Empty pipette EMPTY PIPET ARE YOU SURE iur ESCAPE This function can be used to empty a pipette that may have remained filled due to an error condition The function is performed on the pipette that is currently at the nozzle position Press ENTER to confirm the selection and start the function N NOTE Qm To empty another pipette use function CARoUSEL M33 in the menu MOTOR CONTROL to move the pipette to the nozzle position and then use function EMPTY PIPET Page 82 StaRRsed Inversa User manual Version 1 06 MRN 141 EN R mechatronics User interface 7 5 3 Service menu section Service functionality can be accessed with chip card types S l and T Note Software version Main 1 30 Slave 1 O 1 15 Display 2 14 or higher Page 83 StaRRsed Inversa User manual Version 1 06 MRN 141 EN mechatronics User interface 7 5 3 1 Menu 5 Settings Service EN DISABLE PIPET PRINT SETTINGS SELECT 30 MIN METHOD EDTA MODE TEMPERATURE T CORR CAROUSEL POSITION NEXT SELECT Next submenu DST Daylight Saving Time RESULT AT LIMIT PRINTER RESULTS DATE TIME LANGUAGE ESR TIME MIN NEXT Be
33. N mechatronics Appendix for StaRRsed Inversa e When the string is not OK it is responding with an NACK and the Host computer must send the conformation string again After 3 attempts the Host computer must stop sending the conformation string and the StaRRsed Inversa won t do an ESR on this sample and goes to the next sample The Host computer needs to be ready for the request string of the next sample e lf the StaRRsed Inversa does not receive the conformation string within 10 seconds it will send the request string again After 3 attempts it won t do an ESR on this sample and goes to the next sample e If the StaRRsed Inversa receives a NACK it will send the request string again After 3 attempts it will stop communication and generate an error e If the StaRRsed Inversa does not get any response timeout 10 sec it will send the request string again After 3 attempts it will stop communication and generate an error Request string example Sample ID 123456789 Request string ESRSR 123456789 R 31 bytes Sample result e Checksum ON OFF user defined e 30 minute output ON OFF user defined The sample result will be output according to the standard Compact StaRRsed ESR string See String format for StaRRsed If the host computer receives the result string it should reply by sending an ACK or a NACK e If the StaRRsed Inversa receives an ACK it will start sending the next result e f the StaRRsed Inver
34. Rsed Inversa Appendix Tube connection StaRRsed Inversa StaRRsed Inversa User manual Page 141 Version 1 06 MRN 141 EN mechatronics Appendix for StaRRsed Inversa Instrument development www mechatronics ni FORMAT A4 P UNITS mm PAR DATE DRAWING NUMBER CREATED M B 11 02 2008 Page 142 StaRRsed Inversa User manual Version 1 06 MRN 141 EN mechatronics Appendix for StaRRsed Inversa Appendix Factory default settings StaRRsed Inversa Menu text Setting Menu an A d Client settings 30 MIN METHOD Lab supervisor OFF OFF EDTA MODE Lab supervisor ON ON TEMPERATURE Lab supervisor room temperature room temperature Set T CORR meo ON ON Set DST Lab supervisor OFF OFF Set RESULT AT LIMIT Lab supervisor ON ON PRINTER RESULTS Lab supervisor ON ON Set system DATE TIMET Lab supervisor 00 00 00 Time Set system DATE TIME Lab supervisor 01 01 1998 Date Select LANGUAGE Lab supervisor English English Adjust temp Sensor Lab supervisor 18 3 18 3 ESR TIME MIN Lab supervisor 60 Min 60 Min PROTOCOL Lab supervisor NO SERIAL OUTPUT NO SERIAL OUTPUT Set BAUDRATE Lab supervisor 9600 9600 30 MINUTE OUTPUT Lab supervisor OFF OFF CHECKSUM Lab supervisor OFF OFF ACK NACK Lab supervisor OFF OFF BARCODE READER Service Keyence Keyence MAX NEEDLE CURRENT Service 180 180 SET PISTON POSITION
35. Service 900 890 StaRRsed Inversa User manual Version 1 06 MRN 141 EN Page 143 R mechatronics Appendix for StaRRsed Inversa Appendix Maintenance schedule StaRRsed Inversa Maintenance schedule StaRRsed Inversa Sample volume 200 Per day Daily oda Level 5 Level 4 Level 3 Level 2 Level 1 amount Daily Sample volume 150 EESTI Fr RE End of day wash procedure Wash all pipettes Ga jWwmwesewr oo o Te DCN NENNEN NENNEN AA check PP BEE ISO OS ISO IO OS EEE check yo EEE ss NN MEM MN NE EF NET NES NES medie eyes o Based on 9000 Run land cean procedure Clean em a Aw StaRRsed Inversa User manual Page 145 Version 1 06 MRN 141 EN mechatronics Appendix for StaRRsed Inversa Appendix String format for StaRRsed ESR string format for StaRRsed 60 minutes format Stx PPPPPPPPPP www WWW AAAAAAAAmm ppp TTT CC EEEEEEEEEEEEEEEEEEEEEE MMMMMMMMMM cr 1f eot stx 80 data characters cr If eot Checksum OFF 60 min 80 data characters eot Checksum ON 60 min Posion ewm Rema 10 Paton ornano En u eere O Ee m 18 20 ESR inn 60 min cores totem xw WWW AA Tet jAWMMM S ar 22 tamy ade pode O O O EN EN Is EN La Evormesseoes Ton FEECEEEEEEEEECEEEEEEEE _ m eDTAmessage Ted Jim O OOOO CS 1 byte checksum 256 modulo 256 ASCII
36. The data can be send to your Lab Information System Minimum sample volume is 1 2 ml for the StaRRsed Inversa The StaRRsed Inversa can use a variety of closed tubes from different manufacturers StaRRsed Inversa User manual Page 9 Version 1 06 MRN 141 EN Rm mechatronics Introduction 1 1 About this manual This manual describes all necessary procedures and information required for the correct and successful use of the StaRRsed Inversa covering installation normal operation user maintenance and troubleshooting This manual does not describe specific service related issues such as detailed technical information and repair procedures In this manual the following graphical symbols are used to draw attention to important information related to any specific danger NOTE This symbol indicates a reference to this or other product documentation _ NOTE A This symbol indicates useful tips and other important information that are not 1 2 Dilution principle When the StaRRsed Inversa is operating in the EDTA mode the blood sample must be diluted with sodium citrate during the aspiration process On the StaRRsed Inversa the dilution is achieved through a mechanical link between the syringe on the diluter and the pipette piston The dilution ratio is 4 volumes blood 1 volume sodium citrate diluent accuracy 2 Page 10 StaRRsed Inversa User manual Version 1 06 MRN 141 EN Ra mechatronics Introduction 1 3 Se
37. USER MANUAL STARRSED INVERSA USER MANUAL Version 1 06 MRN 141 EN Master Registration Number MRN 141 EN mechatronics Manufacturer Mechatronics Manufacturing B V Phone 31 0 229 29 11 29 Fax 31 0 229 24 15 34 E mail support mechatronics nl Internet http www mechatronics nl P O Box 225 Postal address 1620 AE Hoorn The Netherlands De Corantijn 13 Office address 1689 AN Zwaag The Netherlands Copyright Mechatronics BV All rights reserved Subject to changes without prior notice Issued by the After Sales Department of Mechatronics mechatronics Document history overview Document history overview MRN 141 EN Published date Monday December 19 2011 Il Dijk Septembe New version Error H E van list Dijk A H E van Inversa Keyboard Menu options added H E van Dijk January Al e Replaced Key card for Chip card Attention markers for User Supervisor and Technician Included in menu descriptions May 2011 Introduction Line The used sedimentation pipettes are Glossary automatically washed and dried removed Explanation IVD added Minor changes throughout manual explanations added for user interface 1 04 February Work instruction Removed check waste 2011 401 pump tube condition from WI 401 Appendix Appendices added Tube connections factory settings maintenance schedule StaRRsed Inversa User manual Page 3 Version 1 06 MRN 141 EN mechatron
38. Version 1 06 MRN 141 EN RQ mechatronics Waste disposal Install the empty container in the reversed order p nun NOTE A If you are re cycling the waste container make sure that it is bleached and rinsed thoroughly StaRRsed Inversa User manual Page 105 Version 1 06 MRN 141 EN mechatronics Reporting 12 REPORTING The StaRRsed Inversa is able to transmit different types of reports to the serial output port In Menu 5 Settings Lab Supervisor the following options are selectable 30 MIN METHOD on off CHECKSUM on off ACK NACK on off 30 MINUTE OUTPUT on off CHECKSUM is select ON at the end of the string an extra byte is added Checksum output string 1 byte checksum 256 modulo 256 ASCII string sum This output is also known as the advanced output ACK NACK is select ON a confirmation is expected from the host computer after serial transmission After receiving a Nack StaRRsed sends the data again maximum two times An Ack will let the StaRRsed carry on immediately If Ack Nack is not received the Instrument carries on after a pause of 1 second between the transitions ACK Acknowledge NACK Not acknowledge See also Appendix String format for StaRRsed on page 147 30 MINUTE OUTPUT is ON the format of the report is changed independent of the selection of the status of checksum or ACK NACK 30 METHOD is ON the ESR time automaticall
39. ans 42 mm in the 30 minute method and temperature correction 75 with a correct column height e L_err 84 75 200 means 84 mm in the 60 minute method and temperature correction 75 with a correct column height 12 2 5 Reporting range The reporting range in the lines 2 3 and 4 are in millimeters The start of the measure range is at the top of the meniscus down to 140 mm If the detection of cells plasma is over 140 mm then the report will be gt 140 StaRRsed Inversa User manual Page 113 Version 1 06 MRN 141 EN Reporting 12 2 6 Aspect Hazy mechatronics The automatic reading of the Westergren sedimentation pipettes is carried out by moving an optical sensor along the pipettes While the sensor is moving a reading is made every 0 25 mm The sensor is reading the absorption of infra red light through the Westergren pipette filled with blood From these readings values at a number of absorption levels are determined All absorption figures are relative to the darkest and lightest reading darkest 100 and the lightest 0 96 absorption respectively By definition the levels are 87 5 Cells plasma separation 75 0 Hazy detection 50 0 Meniscus detection hazy gt 25mm hazy 1025 mm 25 hazy 10mm 10 dear lt 3mm _3 cells p 100 0 N t Y 70 IB 2 clear hazy lt 10 mm E 60 2 i z 1 3 40 2 out off e 3 measure area 20 LI L ol
40. ars worn or leaking Page 176 StaRRsed Inversa User manual Version 1 06 MRN 141 EN Ro mechetronics Work instruction StaRRsed Inversa 18 1 WI 403 Level 3 maintenance RR mechatronics Work instruction Number 403 Page 1 of 1 Purpose Level 3 maintenance Safety Bio Hazard area Instrument StaRRsed Inversa Revision Draft September 2010 NOTE Chip card type S is required Prepare disinfectant if not already prepared 180 Add 10 ml bleach sodium hypochlorite to 190 ml de ionized water 5 solution This disinfectant is for cleaning of all external parts that are exposed to blood 1 Wipe the lower tube holder of the needle unit 2 Wipe the stainless steel drip plates below the pipette carousel and needle unit 3 Inthe Main menu use the function END_OF_DAY WASH 4 Check the system for leakage StaRRsed Inversa User manual Page 177 Version 1 06 MRN 141 EN R mechatronics Work instruction StaRRsed Inversa 5 Inspect sample needle condition Menu SERVICE MOTOR CONTROL NEEDLE M31 Press ARROW DOWN twice to expose the needle tip If the tips are worn replace the needle assembly 6 Check the waste pump tube condition Replace the tube if it appears worn or leaking Page 178 StaRRsed Inversa User manual Version 1 06 MRN 141 EN Ro mechetronics Work instruction StaRRsed Inversa RR mechatronics Work instruction Number 404 Page 1
41. ased knowledge of disease transmission and occupational hazards may result in situations currently considered safe to be reclassified as having risk Universal Precautions describes a set of procedures for dealing with subjects based on the assumption that they are positive for blood borne pathogens Other precautions are necessary to prevent exposure to potential respiratory diseases 4 2 2 Medical requirements Routine personal medical assessments are advised at regular intervals yearly for all personal exposed to potential biohazard Immunisation for Hepatitis B is recommended for everyone who is taking blood samples or dealing with human blood or bodily fluids 4 2 3 General laboratory practices The laboratory is a shared facility it must be booked in advance with the Technician in Charge All users must follow all Departmental Safety Guidelines and Bio safety Policy Each user is responsible to leave a clean disinfected and tidy work place All biohazard waste must be properly disposed StaRRsed Inversa User manual Page 31 Version 1 06 MRN 141 EN Rm mechatronics Standard Operating Procedures S O P 4 2 4 Specific laboratory practices and requirements Biohazard waste Dispose blood tubes into a biohazard sharps container Dispose sharps into a biohazard sharps container All other bio hazardous waste is to be deposited into a biohazard bag All bio hazardous waste is deposited into the Medical Was
42. atory World 1994 Allowed blood specimen types For EDTA mode Whole blood with lt 1 EDTA anticoagulant For Citrate mode Whole blood 4 vols with sodium citrate anticoagulant diluent 1 vol Automatic dilution 4 vols blood 1 vol sodium citrate diluent 3 2 NaCl accuracy 2 Reported result mm hr Reagents Reagents used QRR 010931 Diluent QRR 010946 X Clean Blood volume Aspirated blood volume per sample 1 2 ml in EDTA mode 1 4 ml in Citrate mode Sample tube types Sample tube types Barcode reader Barcode reader type Most commonly used brands types Closed tubes with concentrical cap only e Totallength 73 93mm e Body diameter 11 5 15 5 mm e Capdiameter 13 18mm CCD Reading capabilities Most common barcode labels Code39 ITF Industrial 2 or 5 CodaBar EAN UPC and CODE128 Page 18 StaRRsed Inversa User manual Version 1 06 MRN 141 EN mechatronics StaRRsed Inversa power requirements Instrument description 115 230V AC 50 60Hz Mains voltage Fuse 20 x 5 mm Slow blow 230V 1 6 Amp Slow blow 115V Power consumption Standby 2 5 Amp 30 VA 100 VA Maximum Heat output Standby Full operation 16 Watt 30 Watt StaRRsed Inversa environment Less than 58 dBA Sound level 18 28 C Environment temperature Relative humidity 10 90 StaRRsed Inversa overall dimensio
43. atronics Request record from analyzer to LIMS Request capital R on position 125 Appendix for StaRRsed Inversa STX Data R space CS ETX Workorder record from LIMS to analyzer ESR Yes capital Y on position 125 STX Data Y space CS ETX ESR No capital N on position 125 STX Data N space CS ETX MECHATRONICS result record 2 254 255 256 STX Data 253 characters ETX of Position Data field Bytes Format Comment 1 Start of text 1 STX 2 Text distinction code 8 ESRRE Left aligned followed by spaces 10 Instrument ID 20 text If applicable 30 Sample ID 40 text 70 Reserved spaces 15 text 85 Aspiration date 10 ddmmyyyy Text format E g 01012010 January 1 2010 StaRRsed Inversa User manual Version 1 06 MRN 141 EN Page 157 Appendix for StaRRsed Inversa mechatronics 95 Aspiration time 5 hhmm Text format E g 0001 0 01 24 hour clock 100 ESR 30 minutes mm h 5 XXXXX 105 E S R in mm 60 minute mm h 5 XXXXX 110 ESR 60 minutes temperature corrected mm h 5 XXXXX 115 ESR 120 minutes mm h 5 XXXXX If applicable 120 Reserved spaces 10 text 130 Sample code 5 XXXXX See section Sample codes 135 Aspect code 5 XXXXX See section Aspect codes 140 Manually added code 5 XXXXX 145 Pipette n
44. card e Press 1 Sample mode Page 128 StaRRsed Inversa User manual Version 1 06 MRN 141 EN R mechatronics Appendix for StaRRsed Inversa 17 APPENDIX FOR STARRSED INVERSA Appendix section StaRRsed Inversa User manual Page 129 Version 1 06 MRN 141 EN mechatronics Appendix for StaRRsed Inversa Appendix Error list StaRRsed Inversa E ees o hm Remark Possible cause Unknown function Function is under construction Not programmed Unknown menu Not Menu is under construction programmed Carrousel position error Set correct rinse Sensor value does not match with the position value stored in memory e Setcorrect carrousel position and or do a Learn positions e Carrousel Position sensor malfunction Checksum error Default Check settings Calculated checksum does not match RAM settings are loaded with the checksum stored in RAM e Empty battery on main board RTC DS1302 malfunction Number not assigned Se Internal I2C communication If this error occurs repeatedly contact error local service engineer Waste bottle full Empty waste bottle e Level sensor malfunction and clear error Warning Diluent bottle Fill Diluent bottle e Level sensor malfunction empty Warning Cleaning Solution Fill Cleaning Solution e Level sensor malfunction bottle empty bottle Unknown status in cleaning Reset the instrument If this error occurs repeatedly contact routine local service eng
45. covered DELETE PIPET DATA SAMPLES WILL BE LOST ARE YOU SURE gt ESCAPE Press ENTER to confirm the selection and start the function DELETE HIST DATA SAMPLES WILL BE LOST ARE YOU SURE Page 66 StaRRsed Inversa User manual Version 1 06 MRN 141 EN R mechatronics User interface Es ESCAPE Press ENTER to confirm the selection and start the function StaRRsed Inversa User manual Page 67 Version 1 06 MRN 141 EN Ra mechatronics User interface 7 5 2 2 Menu 5 Settings Lab Supervisor EN DISABLE PIPET PRINT SETTINGS Next submenu 30 MIN METHOD EDTA MODE TEMPERATURE TCORR CAROUSEL POSITION NEXT L1 ESCAPE Next submenu q SELECT DST Note Daylight Saving Time RESULT AT LIMIT PRINTER RESULTS DATE TIME LANGUAGE ESR TIME MIN NEXT or ESCAPE Next submenu E m SELECT JE Page 68 StaRRsed Inversa User manual Version 1 06 MRN 141 EN mechatronics User interface PROTOCOL BAUDRATE CHECKSUM ACK NACK 30 MINUTE OUTPUT ESCAPE RP SELECT To return to the previous settings screen press ESC To return directly to the Main menu keep ESC pressed until the Main menu is displayed 7 5 2 2 1 Menu 30 min method 30 MIN METHOD SETTING OFF ut ESCAPE mg SELECT When this setting is ON the pipettes are measured after 30 minutes instead of 60 minut
46. ctory settings 88 Menu Language 74 Menu Load credits 60 91 Menu Max needle current 87 Menu Measure pipette 81 Menu Motor control 79 Menu Patient data 45 Menu Position data 45 Menu Print data 46 Menu Print error history 57 Menu Print graph 48 Menu Print raw data 47 48 Menu Print settings 56 Menu Printer results 73 Menu Protocol 75 Menu Read barcode 81 Menu Read service card 62 93 Menu Replace pipette 82 Page 184 mechatronics Menu Result at limit 72 Menu Send data 49 Menu Sensor status 80 Menu Set blood sensor 86 Menu Set piston position 86 Menu Set waste sensor 86 Menu Show error history 57 Menu Software versions 58 Menu structure StaRRsed Inversa 43 Menu Toorr 71 Menu Temperature 70 Menu Valve control 80 MRN 181 N Navigating through the menus 40 P Placing sample tubes on the needle system 99 Power failure 119 Power up sequence 95 Priming the fluid system 98 Printer paper replacement 96 Protocols 108 Q QUICK START UP 95 R Reagents 125 Replacing a pipette 127 Report 30 Minute mode 110 Report 60 Minute mode 109 REPORTING 107 Reporting range 113 Result Printout 108 Results at limit errors 113 RS232 serial output 119 S S O P for working with bio hazardous materials 31 SAFETY WARNING 37 Sample Mixing 99 SAMPLE ROUTINE PROCEDURE 99 Sample screen 44 Sample tubes w
47. d spaces 15 text 85 Aspiration date 10 ddmmyyyy Text format E g 01012010 January 1 2010 95 Aspiration time 5 hhmm Text format E g 0001 2 0 01 24 hour clock 100 ESR 30 minutes mm h 5 XXXXX 105 E S R in mm 60 minute mm h 5 XXXXX 110 ESR 60 minutes temperature corrected mm h 5 XXXXX 115 ESR 120 minutes mm h 5 XXXXX If applicable 120 Reserved spaces 10 text 130 Sample code 5 XXXXX See section Sample codes 135 Aspect code 5 XXXXX See section Aspect codes StaRRsed Inversa User manual Version 1 06 MRN 141 EN Page 163 mechatronics Appendix for StaRRsed Inversa 140 Manually added code 5 XXXXX 145 Pipette numberPipette number 5 XXXXX 150 Sedimentation time minutes 5 XXXXX 155 Temperature 5 XXXXX 160 Dilution rate 5 XXXXX 165 Column height mm 5 XXXXX 170 Error code 5 XXXXX See section ESR error codes 175 Limit error message results 30 text See section Limit error message 205 Reserved spaces 50 text 255 Checksum 1 CS See section Checksum calculation 256 End of text 1 ETX Total 256 Text left aligned followed by spaces XX number digits 0 9 with leading spaces Non specified positions are filled with spaces Pe taRRsed Inversa User manual Version 1 06 MRN 141 EN mechatronics Sample type Transmitted code Patient sample 0 QC normal 1 QC abnormal 2 Appendix for StaRRsed Inversa No
48. d by pressing CANCEL END OF DAY WASH ARE YOU SURE StaRRsed Inversa User manual Page 51 Version 1 06 MRN 141 EN mechatronics User interface ESCAPE Yes END_OF_DAY WASH CANCELLED WAIT u CANCEL When the last sample is more then 12 hours ago an END OF DAY WASH warning is shown on the display with the recommendation to activate the END OF DAY WASH function Page 52 StaRRsed Inversa User manual Version 1 06 MRN 141 EN mechatronics 7 5 1 5 Menu 4 Prime Prime CONTINUE 2 ESCAPE Press ENTER to start the function Prime BUSY PLEASE WAIT _ CANCEL The function may be cancelled by pressing CANCEL Prime CANCELLED WAIT u CANCEL StaRRsed Inversa User manual Version 1 06 MRN 141 EN User interface Page 53 mechatronics User interface When the last prime function is more then 12 hours ago a PRIME warning is shown on the display with the recommendation to activate the PRIME function 7 5 1 6 Menu 5 Settings User EN DISABLE PIPET PRINT SETTINGS EJ E E ESCAPE M SELECT al 7 5 1 6 1 Menu En disable pipet EN DISABLE PIPET PIPET NUMBER 19 PIPET EMPTY 1 OX0000000000 12 13 00000X000000 24 Page 54 StaRRsed Inversa User manual Version 1 06 MRN 141 EN mechatronics User interface E gt ESCAPE Supe SELECT The status of the current pipette is shown at the to
49. dimentation measurement principle The automatic reading of the Westergren sedimentation pipettes is carried out by moving an optical sensor along the pipettes While the sensor is moving a reading is made every 0 25 mm The sensor is reading the absorption of infra red light through the Westergren pipette filled with blood From these readings values at a number of absorption levels are determined All absorption figures are relative to the darkest and lightest reading darkest 100 and the lightest 0 absorption respectively By definition the levels are 87 5 Cells plasma separation 75 0 Hazy detection 50 0 Meniscus detection hazy gt 25mm hazy 1025mm _ 5 w hazy 10mm 10 dear lt 3mm 3 celis p 100 0 N v 70 e clear hazy lt 10 mm E 60 g gt 50 3 40 2 out off gt 3 measure area 20 10 U C j NN Le O YAS COR PA Y ER AA MEA me 9 so 100 150 200 250 pipet column bottom sedimentation 110mm height Graphic showing typical absorption values of a sample StaRRsed Inversa User manual Page 11 Version 1 06 MRN 141 EN mechatronics Instrument description 2 INSTRUMENT DESCRIPTION The StaRRsed Inversa is a semi automatic ESR instrument The blood sample tubes must be mixed externally before they are loaded into the sample holder one at a time The instrument can be configured to work with pre citrated samples Citrate m
50. e automatic rinsing of the sample system between samples e Approximately 5 ml Diluent is used for each sample cycle The on board container for Diluent is a 1 liter plastic bottle Fill the container with Diluent from the 5 liter bulk container QRR 010931 The solution should be discarded if it becomes turbid If the Diluent does become turbid clean the Diluent container thoroughly with a 5 Na hypochlorite solution After cleaning rinse the container thoroughly with de ionized water Before refilling flush the Diluent bottle with a little Diluent from the bulk container NOTE BH The latest version of the Material Safety Data Sheet MSDS of the used reagents can be found on our web site www mechatronics nl http www mechatronics n 8 4 2 X Clean QRR 010946 X Clean is a ready to use cleaning solution that is used for the End of day wash The solution removes residual proteins from the inner wall of the Westergren pipettes The on board container for X Clean is a 1 liter plastic bottle Fill the container with X Clean from the 5 liter bulk container QRR 010946 NOTE The latest version of the Material Safety Data Sheet MSDS of the used reagents can be found on our web site www mechatronics nl http www mechatronics n 8 5 Priming the fluid system After starting the StaRRsed Inversa a warning may appear on the screen stating that the last prime cycle was more than 12 hours ago Press ENTER to start
51. e plastic bag from the StaRRsed Inversa 5 Lift the StaRRsed Inversa from the bottom protection cover onto a table StaRRsed Inversa User manual Page 21 Version 1 06 MRN 141 EN mechatronics Installation 3 2 Install at chosen location Install the StaRRsed Inversa in a location with the following specifications Avoid direct sunlight shining on the StaRRsed Inversa Avoid droughts which may cause temperature changes Place the StaRRsed Inversa on a stable table with no nearby vibration Do not place in direct airflow of an air conditioning unit Place the instrument on a stable table with no nearby vibration Leave a space of approximately 15 centimeters between the back side of the instrument and the wall to allow warm air to escape and to connect or run interface cables 7 Level the instrument by using the three adjustable feet and the leveling gauge which is situated at the carousel oarhanh gt 3 2 1 Table size StaRRsed Inversa table size Min table size Width 800 mm Depth 750 mm StaRRsed Inversa User manual Page 23 Version 1 06 MRN 141 EN mechatronics Installation 3 3 Start up the first time Before using the StaRRsed Inversa for the first time the following items must be attended Install the stainless steel drip plates under the carousel and needle unit slide into position Make sure the tube is installed in the pinch valves at the needle assembly Connect mains switch ON
52. echatronics User interface 7 5 2 2 15 Menu ACK NACK ACK NACK NOT APPLICABLE E ESCAPE a SELECT Note This setting is only appliable if the output protocol is set to Compact unidirectional or Compact bidirectional 7 5 2 2 16 Menu 30 minute output 30 MINUTE OUTPUT SETTING OFF E ESCAPE Apr SELECT Note This setting is only appliable if the output protocol is set to Compact unidirectional or Compact bidirectional StaRRsed Inversa User manual Page 77 Version 1 06 MRN 141 EN Rm mechatronics User interface 7 5 2 3 Menu 6 Service Lab Supervisor 2 2 2 0 ERROR HISTORY SOFTWARE VERSIONS DISPLAY S N mx i L1 ESCAPE P SELECT Next submenu MOTOR CONTROL VALVE CONTROL SENSOR STATUS MEASURE PIPET READ BARCODE REPLACE PIPET NEXT L1 ESCAPE Next submenu EMPTY PIPET Page 78 StaRRsed Inversa User manual Version 1 06 MRN 141 EN RQ mechatronics User interface 7 5 2 3 1 Menu Motor control WASTE M34 MEAS M28 Nozzle M29 FILLING M30 NEEDLE M31 GRIPPER M32 CAROUSEL M33 amp 2 ESCAPE i i SELECT adl These functions can be used to test the function of the motors or to move the associated unit to a particular position for service and maintenance reasons Select the required motor and use the ARROW DOWN or ARROW UP keys to switch the motor ON or OFF A StaRRsed
53. ed results StaRRsed Inversa User manual Page 47 Version 1 06 MRN 141 EN R mechatronics User interface 7 5 1 3 4 1 Menu Print raw data PRINT RAW DATA 2 ESCAPE Put the sample tube into the needle holder and press ENTER to get the patient ID from the barcode label or enter the ID manually and then press ENTER 7 5 1 3 4 2 Menu Print graph PRINT GRAPH 2 ESCAPE Put the sample tube into the needle holder and press ENTER to get the patient ID from the barcode label or enter the ID manually and then press ENTER Page 48 StaRRsed Inversa User manual Version 1 06 MRN 141 EN mechatronics 7 5 1 3 5 Menu Send data SEND DATA TODAY S RESULTS YESTERDAY S RESULTS DATE ESCAPE sme SELECT Press ENTER to start the function TODAY S RESULTS CONTINUE ESCAPE or YESTERDAY S RESULTS CONTINUE StaRRsed Inversa User manual Version 1 06 MRN 141 EN User interface Page 49 mechatronics User interface 2 ESCAPE Use these functions to send all sample results from the selected day to the HOST Page 50 StaRRsed Inversa User manual Version 1 06 MRN 141 EN mechatronics User interface 7 5 1 4 Menu 3 End of day wash END OF DAY WASH CONTINUE 2 ESCAPE Press ENTER to start the function END OF DAY WASH BUSY PLEASE WAIT u CANCEL The function may be cancelle
54. eight must be between 180 and 210mm nnn the actual column height Measure error WARNING The down count is not equal to the up count from the measure head Bubbles on top WARNING Air bubbles on top of the ESR Limit error ERROR One of the following limits are out of range e The ESR time e The column height e Dilution errors Page 112 StaRRsed Inversa User manual Version 1 06 MRN 141 EN mechatronics Reporting 12 2 4 Results at limit errors When this option is set to YES and a limit error occurs results will be printed send to the LIMS When this option is set to NO and a limit error occurs the fields for 30 min ESR 60 min ESR and the temperature corrected ESR are filled with spaces and thus results are not printed send to LIMS The error message in the error field column 10 indicates that at least one of the the limits ESR time dilution rate or column height has been exceeded Together with the sedimentation time and dilution rate which are still printed at the usual position the operator can see what caused the error and may or may not use the ESR values which are preserved in the error message Description of the error message L_err hhh www ttt ccc e L errmeansitis a limit error e hhh is the 30 minutes ESR e WWW is the 60 minute ESR e ttt is the temperature corrected 60 minute result e ccc is the column height Example of a limit error message e L_err 42 84 75 200 me
55. enu SERVICE MOTOR CONTROL NEEDLE M31 Press ARROW DOWN twice to expose the needle tips If the tips are worn replace the needle gt StaRRsed Inversa User manual Page 173 Version 1 06 MRN 141 EN mechatronics Work instruction StaRRsed Inversa Page 174 StaRRsed Inversa User manual Version 1 06 MRN 141 EN Ro mechetronics Work instruction StaRRsed Inversa RR mechatronics Work instruction Number 402 Page 1 of 1 Purpose Level 2 maintenance Safety Bio Hazard area Instrument StaRRsed Inversa Revision Draft September 2010 NOTE Chip card type S is required Prepare disinfectant if not already prepared 180 Add 10 ml bleach sodium hypochlorite to 190 ml de ionized water 5 solution This disinfectant is for cleaning of all external parts that are exposed to blood 1 Wipe the lower tube holder of the needle unit 2 Wipe the stainless steel drip plates below the pipette carousel and needle unit e In the Main menu use the function END OF DAY WASH Check the system for leakage 5 Inspect sample needle condition Menu SERVICE MOTOR CONTROL NEEDLE M31 Press ARROW DOWN twice to expose the needle tip If the tips are worn replace the needle assembly gt StaRRsed Inversa User manual Page 175 Version 1 06 MRN 141 EN Rm mechetronics Work instruction StaRRsed Inversa 6 Check the waste pump tube condition Replace the tube if it appe
56. er e Serial number chip malfunction SPI error If this error occurs repeatedly contact local service engineer e Flash memory malfunction Write mode error If this error occurs repeatedly contact local service engineer e Flash memory malfunction Sector protection error If this error occurs repeatedly contact local service engineer e Flash memory malfunction Pipette data write error If this error occurs repeatedly contact local service engineer e Flash memory malfunction Patient data write error If this error occurs repeatedly contact local service engineer e Flash memory malfunction Patient write read index If this error occurs repeatedly contact write error local service engineer e Flash memory malfunction Page 134 StaRRsed Inversa User manual Version 1 06 MRN 141 EN mechatronics Appendix for StaRRsed Inversa Block erase error If this error occurs repeatedly contact local service engineer e Flash memory malfunction Pipette data erase error If this error occurs repeatedly contact local service engineer e Flash memory malfunction Pipette data corrupt If this error occurs repeatedly contact local service engineer e Flash memory malfunction Settings write error If this error occurs repeatedly contact local service engineer e Flash memory malfunction Card amp Credit data write If this error occurs repeatedly contact error l
57. es The obtained reading is converted to a predicted 60 minute result Use the ARROW DOWN or ARROW UP keys and select the required option Then press ENTER to save the new setting StaRRsed Inversa User manual Page 69 Version 1 06 MRN 141 EN R mechatronics User interface 7 5 2 2 2 Menu EDTA mode EDTA MODE SETTING ON wur ESCAPE ge SELECT Use the ARROW DOWN or ARROW UP keys and select the required option Then press ENTER to save the new setting NOTE AU a A small hardware modification is necessary to switch between EDTA mode and Citrate mode See work instruction WI 405 for details 7 5 2 2 3 Menu Temperature TEMPERATURE CURRENT 21 C INPUT E ESCAPE The displayed value is the temperature according the build in thermometer of the StaRRsed Inversa Check the actual temperature near the pipettes with an external thermometer If the values do not match enter the correct value Then press ENTER to save the new setting Page 70 StaRRsed Inversa User manual Version 1 06 MRN 141 EN R mechatronics User interface 7 5 2 2 4 Menu Tcorr TCORR SETTING ON ESCAPE p SELECT This option is used to set if Temperature correction is to be applied on the measured ESR results Use the ARROW DOWN or ARROW UP keys and select the required option Then press ENTER to save the new setting 7 5 2 2 5 Menu Carousel po
58. ette During this fill motion the diluter syringe is driving the diluent via the nozzle into the blood stream N NOTE ndi If the StaRRsed Inversa is set to bidirectional communication with a HOST and ESR measurement is not required for this sample the message No ESR is shown on the display The sample will not be aspirated and may be removed from the needle unit Page 100 StaRRsed Inversa User manual Version 1 06 MRN 141 EN mechatronics Sample routine procedure 9 4 Aborting the sample sequence If a clean pipette is not available yet and sampling has not started yet it is possible to abort the sample by pressing the CANCEL key PN NOTE PP u As soon as the tube starts to move over the needle it is not possible to cancel the aspiration sequence 9 5 Automatic rinsing of the sample system After each aspiration the sample needle sample tubes and fill nozzle are automatically washed with diluent 9 6 Fill errors during sampling After filling the sample into the pipette the quality of the aspiration is checked by pre measuring the pipette The following parameters are checked e the column height e the usage of diluent e possible air bubbles If there are any deviations a beep will sound after the check StaRRsed Inversa User manual Page 101 Version 1 06 MRN 141 EN R mechatronics Turn off 10 TURN OFF It is recommended to turn the StaRRsed Inversa off at the end of the day Before the in
59. for it All specified RS232 signals are completely isolated from the computer earth and the mains supply Handshake Hardware handshake is not applied Change the data transmission parameters From the transmission parameters only the baud rate can be selected from 1200 up to 9600 StaRRsed Inversa User manual Page 169 Version 1 06 MRN 141 EN mechatronics Appendix for StaRRsed Inversa Appendix Configuration barcode readers The Barcode interface can handle two types of barcode readers e The Opticon 6 mil resolution e The Keyence 4 mil resolution If you are using labels with a higher density contact your local distributor or agent The Barcode reader may be set to accept check digits however this needs to be programmed by the distributor Coda bar Code 39 Code128 UPC EAN and ITF 2 or 5 barcode types can be read with those barcode reader types To set up the barcode readers to client specifications use the set up tools for the barcode readers Detailed information can be found in Keyence Configuration manual MRN 011 or in Opticon Configuration manual MRN 015 Page 170 StaRRsed Inversa User manual Version 1 06 MRN 141 EN R mechatronics Work instruction StaRRsed Inversa 18 WORK INSTRUCTION STARRSED INVERSA Work instruction section StaRRsed Inversa User manual Page 171 Version 1 06 MRN 141 EN Rm mechetronics Work instruction StaRRsed Inversa Rm mechatronics Work ins
60. he StaRRsed Inversa LOAD CREDITS CONTINUE E ESCAPE Press ENTER to start the function LOAD CREDITS Do NOT REMOVE CARD BUSY PLEASE WAIT Es ESCAPE StaRRsed Inversa User manual Page 91 Version 1 06 MRN 141 EN mechatronics User interface DONE TyPE Q Note This is the code letter for the type of chip card SN 123456789 Note This is the serial number of the chip card CREDITS XXXXXXX Note This is the total amount of available credit units in memory gt ESCAPE Page 92 StaRRsed Inversa User manual Version 1 06 MRN 141 EN mechatronics User interface 7 5 3 3 2 Menu Read service card Make sure you insert a service chip card type in the chip card reader of the StaRRsed Inversa LOAD CREDITS READ SERVICE CARD ESCAPE p SELECT Select 2 READ SERVICE CARD This function is used to unlock the protected menus and functions READ SERVICE CARD CONTINUE TF Escape Press ENTER to start the function READ SERVICE CARD Do NOT REMOVE CARD BUSY PLEASE WAIT ESCAPE StaRRsed Inversa User manual Page 93 Version 1 06 MRN 141 EN mechatronics User interface READ SERVICE CARD TYPE S Note This is the code letter for the type of chip card SN 123456789 Note This is the serial number of the chip card PASSWORD XXXX Note type the required password for this service chip card
61. his function is used to switch if ESR results must be printed on the build in printer Printing may not be necessary if all results are send to a HOST Use the ARROW DOWN or ARROW UP keys and select the required option Then press ENTER to save the new setting 7 5 2 2 9 Menu Date Time DATE TIME 09 11 2010 12 23 DAY dd INPUT 2 ESCAPE To set the system date and time enter the day number and press ENTER Then continue in the same way with the month year hour and minutes Note When there is no input during 60 seconds the input option is closed StaRRsed Inversa User manual Page 73 Version 1 06 MRN 141 EN R mechatronics User interface 7 5 2 2 10 Menu Language LANGUAGE ENGLISH ESCAPE TET SELECT Select the required language for the user interface 7 5 2 2 11 Menu ESR time min ESR TIME CURRENT 60 INPUT Es ESCAPE This function can be used to temporarily set a different sedimentation time for service or maintenance reasons Enter the required sedimentation time Then press ENTER to save the new setting NOTE Br aa This setting is only active as long as the service chip card is present in the card reader When the chip card is removed the setting is automatically reset to 30 or 60 minutes according the selected method Page 74 StaRRsed Inversa User manual Version 1 06 MRN 141 EN R mechatronics User interface
62. ics Contents CONTENTS 1 INTRODUCTION cs sc es es ee ee wee cena a ces ace cece taeda cnet 9 1 1 About INS gc gO f eee een eee re ee none een eee eee nee ee added 10 JEEP UuegPeqss t 10 1 3 Sedimentation measurement principle 4444444444Hnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn 11 2 INSTRUMENT DESCRIPTION siii nnmnnn nnmnnn 13 2 1 PP A eee tdt 15 2 1 1 Chip Card type A 10 E nl 16 2 1 2 Chipcard Wy OG Me RR 16 2 1 3 Chip card TVPG doc t HON 16 2 1 4 Chip card type M iei 16 2 2 lle 17 2 21 GE Mark StaRRsed IWS aan nrakane ias 20 23 Accessories Md it aia 20 3 INSTALLATION ass 21 3 1 Unpacking Compact system sesssssssssseeeeseeeee enne nnne 21 3 2 Install at chosen LOCA ON nica 23 3 2 1 ile E p ree ee ee eer re 23 23 Start up the first ie T RI 25 4 STANDARD OPERATING PROCEDURES S O P eene 27 4 Basics Of Bio Safety a anne ae Una Ert NDS 29 4 2 S O P for working with bio hazardous materials 31 4 2 1 Facts and definitions aan 31 4 2 2 Medical requirements een een 31 4 2 3 General laboratory practices ee 31 4 2 4 Specific laboratory practices and requirements ssseesssss 32 43 StaRRsed Incident Report unisce sende 33 4 4 E C Declaration StaRRsed Compact cccccccnononcccccncccncnnnononcncnonononcnnnnnannnnnononanennnnnos 34 B L
63. ineer Fatal error in cleaning Reset the instrument If this error occurs repeatedly contact routine local service engineer Error in cleaning routine gt If this error occurs repeatedly contact aborted local service engineer Unknown status in fill Reset the instrument If this error occurs repeatedly contact routine local service engineer 16 Fatal error in fill routine Reset the instrument If this error occurs repeatedly contact local service engineer Page 130 StaRRsed Inversa User manual Version 1 06 MRN 141 EN o N al mechatronics Appendix for StaRRsed Inversa 17 Fill timeout Check sample No blood detected within x seconds e Empty sample tube e Blood detection sensor malfunction Fri If this error occurs repeatedly contact aborted local service engineer Numbernotassned i 21 Fill sensor error Check blood e Blood detection sensor out of range EE Hcc dd Numbernotassines Numbernotassoned SCS Mumbernotassines Filling motor could not go Gripper must be open x nome eco ud Gripper sensors malfunction is closed Not allowed to start Filling Carrousel home sensor malfunction motor Carrousel is not at a defined position Filling motor could not go Gripper must be open gown al moway Eper Gripper sensors malfunction is closed Filling motor pulse disk No pulses were detected Position of error filling motor unknown e Pulse disk malfunction e Fill
64. ing in the blood laboratory We advice the use of non canvas closed toe shoes wherever there is a potential for foot injury from hazardous materials or from small physical objects Personal outer clothing should not be stored in the blood laboratory Lab coats worn in the blood laboratory should not be worn outside of the blood laboratory and should not be stored with personal outer clothing to avoid transfer of contaminants Gloves are considered contaminated after ones wearing Avoid contamination of work surfaces with gloves Dispose of gloves into a biohazard container The use of eye protection is advised while processing samples Remove and properly dispose of gloves and wash hands before leaving the laboratory Page 32 StaRRsed Inversa User manual Version 1 06 MRN 141 EN mechatronics Standard Operating Procedures S O P 4 3 StaRRsed Incident Report bo SA StaRRsed Incident mechatronics StaRRsed Incident Report Environmental Health and Safe las Name Fest rame his Company i Names and addresses of witnesses Contributing Factors vt conditions contributed to the incident Number the factors in ceder of importance Details of property damage if any Explanation of contributing factor s Corrective measures Actions to prevent incident recurrence Checionark actors laen fo prevent recumence More than one dem may t t y en parsan vct A rove qusc qa ais exped T wi peed
65. ing motor jammed or malfunction 29 Number not assigned Number not assigned Carrousel could not turn e Gripper must be open Gripper is closed e Gripper sensors malfunction Nh O 00 23 24 N N o al N o Carrousel could not turn e Measuring motor home sensor Measure head not at home malfunction position Carrousel could not turn e Nozzle sensors malfunction Nozzle not at home position Numbernotassigned oo StaRRsed Inversa User manual Page 131 Version 1 06 MRN 141 EN gt 24 29 mechatronics Appendix for StaRRsed Inversa Not possible to open or close gripper Carrousel is not at a defined position Carrousel home sensor malfunction Not possible to move the measure head Carrousel is not at a defined position Carrousel home sensor malfunction Not possible to move Nozzle up or down Carrousel home sensor malfunction 37 Carrousel is not ata defined position 38 Needle current too high Sample tube placed incorrectly Needle motor malfunction Needle motor jammed 9 Number not assigned 40 Unknown status in If this error occurs repeatedly contact measure routine local service engineer Pipette is filled with a sample but not ready for measurement It is not allowed to measure the pipette Number not assigned If this error occurs repeatedly contact local service engineer Error in measure routine gt aborted
66. itch the StaRRsed Inversa ON When the error occurs again switch OFF all units and call for service StaRRsed Inversa User manual Page 123 Version 1 06 MRN 141 EN Ri mechatronics Trouble shooting 16 2 Reagents Check the expire dates of the reagents regularly Do not use the reagents if expired Note lf expired reagent has been used accidentally the results obtained with these reagents may only be used when the expire date was not exceeded more than 30 days Diluent is sensitive for bacterial growth The solution should be discarded if it becomes turbid or infected When using the small onboard containers clean the Diluent container thoroughly with 10 Na hypochlorite Make sure that the container has been thoroughly rinsed after cleaning 16 3 Hazy reports Hazy reports are usually caused by a build up of proteins on the inner wall of the pipettes Another cause is growth of micro organisms in the diluter system It is extremely important that the system is kept clean First run an extra END_OF_DAY WASH then check after a day s run if haziness is decreased When there are still many reports it is recommended to fill the diluter system with a 5 sodium hypochlorite solution A picture example of haziness 16 4 Leaking pipettes Pipettes may be leaking if the plunger tip is worn StaRRsed Inversa User manual Page 125 Version 1 06 MRN 141 EN Rm mechatronics Trouble shooting 16 4 1 Column height
67. ith barcode 99 Sample tubes without barcode 100 Sampling not allowed now 127 Sedimentation measurement principle 11 StaRRsed Inversa User manual Version 1 06 MRN 141 EN mechatronics Service menu section 83 Specific laboratory practices and requirements 32 Specifications for the RS232 port 119 STANDARD OPERATING PROCEDURES S O P 27 StaRRsed Incident Report 33 Start Printout after Switch ON 41 Start up screen 41 Start up the first time 25 Stickers for the onboard reagents bottles 35 Stickers of the reagents containers 35 System messages 117 T Table size 23 Technical specification 17 Temperature correction 181 TROUBLE SHOOTING 123 TURN OFF 103 U Unidirectional 182 Unpacking Compact system 21 USER INTERFACE 39 User menu section 43 65 W Warning screen End of day wash 43 Warning screen Prime 42 Waste container 104 Waste disposal 35 WASTE DISPOSAL 103 Weekly 121 WI 182 WI 403 Level 3 maintenance 121 177 WORK INSTRUCTION STARRSED INVERSA 171 X X Clean QRR 010946 35 98 StaRRsed Inversa User manual Version 1 06 MRN 141 EN Index Page 185
68. ixing 9 2 Placing sample tubes on the needle system 9 2 1 Sample tubes with barcode 9 2 2 Sample tubes without barcode 9 3 Aspirating the sample 9 4 Aborting the sample sequence 9 5 Automatic rinsing of the sample system 9 6 Fill errors during sampling 10 TURN OFF een 10 1 End of day wash procedure 11 WASTE DISPOSAL 11 1 Waste container 12 REPORTING socias AS A A 00000000 PARAS A IN PER STEINER 12 1 Protocols 12 2 Result Printout 12 2 1 Report 60 Minute mode 12 2 2 Report 30 Minute mode Page 6 mechatronics StaRRsed Inversa User manual Version 1 06 MRN 141 EN mechatronics Contents 12 2 3 Analyser ERROR scaricare 111 12 2 3 1 Analyzers Error code MEssages cccccccccccccocococonnnncinininininanininininaninanns 111 12 2 3 2 Explanation of the error messages oooococccccccnccccooncccnoccnnnnnnnnnanannncnnnnnos 112 12 2 4 Results at limit errors esesssesseeenmm mmn nnne nnns 113 12 2 5 Reporting Tangente el nein 113 1226 Aspect PP 114 12 2 6 1 Analyser HAZY code messages ssssssss HH 115 13 INVERSA SYSTEM MESSAGES uuuuua2200u00000n0n0nnanunnnnnunnnnunnnnnunnnnnnnnnnnnnnnnnnannnnn 117 18 1 System MESSI ioci rriv Ex vx VER naar 117 14 DATA MANAGEMENT 1 eneeeeeenrneennee nnne nun nun nun nnnn mann nun nnnnn ann nnnnnnnn mann anne 119 141 PoWwertallrS io 119 14 2 RS232 serial OUtpUt cocooncnnnnnccccnnncnnnnnnn
69. le Example of a limit error message without 30 minute ESR and 120 minute ESR L_err 123 89 200 CS Checksum XOR sum off all the data with the exception of CS STX and ETX E g CS byte2 XOR byte3 XOR byte 4 XOR etc Note Cannot be equal to that of the ETX byte 03h Page 166 StaRRsed Inversa User manual Version 1 06 MRN 141 EN mechatronics Appendix for StaRRsed Inversa The CS byte verifies the accuracy of each transmitted message Before transmission the value of the CS byte is calculated by the exclusive or ing of all data bytes in the message with the exception of CS STX and ETX Since the CS byte precedes the ETX byte within the data stream the calculated value for CS cannot be equal to that of the ETX byte 03h Therefore if the calculated CS value is 03h the transmitted CS byte is set to the substitute value 83h in order to avoid erroneous action by the receiving device StaRRsed Inversa User manual Page 167 Version 1 06 MRN 141 EN R mechatronics Appendix for StaRRsed Inversa Appendix RS 232 DB9 pins female hardware back panel connector The 9 pins sub D female connector is for the serial output of the StaRRsed Inversa beh OOOO get DB9 View looking into male connector bir Notes Description Input Data Carrier Detect Raised by DCE when modem synchronized Input Receive Data a k a RxD Rx Arriving data from DCE Connector layout DB9
70. ll check its memory and if there are filled pipettes on the Instrument these samples will be processed If the sample time has been exceeded the sample result or an error message will be printed in the report printout based on the Result at Limit Error settings 14 1 Power failure If a power failure occurs it is recommended that the StaRRsed Inversa is switched OFF by the power switch When the power returns the Instrument can be switched ON After the standard start up process the StaRRsed Inversa will continue to process the remaining samples If a power failure occurs the sedimentation time 60 or 30 min may be exceeded However the actual sedimentation time is reported to the printer and RS232 and therefore can be checked 14 2 RS232 serial output The StaRRsed Inversa is equipped with a serial port which can be connected to any laboratory host computer system or PC The data sent by the StaRRsed Inversa to the printer can also be sent to a host computer or PC for further processing 14 3 Specifications for the RS232 port RS232 Serial data transmission Baud rate can be set from 2400 to 38400 baud Transmission protocol is default setting 8 bit data 1 stop bit and no parity To change the baud rate go to For more detailed information on the Serial connection see Appendix RS 232 9 pins sub D female hardware connector on page 168 StaRRsed Inversa User manual Page 119 Version 1 06 MRN 141 EN R mechatronics
71. mber on the keyboard The function or menu is activated automatically e Scroll to the required row using the arrow keys and press ENTER to activate The menus SETTINGS and SERVICE contain more functions than can be displayed on one screen To access the next screen you can either e Press number 7 on the keyboard e Scroll to row 7 NEXT using the arrow keys and press ENTER e When the cursor is on row 7 NEXT scroll further down with ARROW DOWN To leave these menus you can e Press ESC to return to the previous screen e When the cursor is on the top row 1 scroll further up with ARROW UP to return to the previous screen e Keep ESC pressed for 2 seconds to return directly to the main menu The default settings in the different menus are printed in Bold In the following tables a check mark V indicates which menus and functions are accessible for which type of operator The access depends on the use of the appropriate chip cards e Uis accessible for the User e Sis accessible for the Supervisor e Tisaccessible for the Technician Menu 1 SAMPLE MODE Menu 2 PATIENT POS DATA Page 40 StaRRsed Inversa User manual Version 1 06 MRN 141 EN mechatronics User interface Menu 3 END_OF_DAY WASH Menu 4 PRIME Menu 5 SETTINGS Menu 6 SERVICE Menu 7 CARD amp CREDITS 7 2 Start up screen STAR EZSED inversa 24H The start up screen is shown for approx 5 sec after the StaRRsed I
72. ne after the last sample run and the StaRRsed Inversa has been idle or switched off for more than the indicated hours Press ENTER to start the function This will ensure that the pipettes are cleaned thoroughly This function can also be started manually at a later time 7 5 Menu structure StaRRsed Inversa Note Software version Main 1 30 Slave 1 O 1 15 Display 2 14 7 5 1 User menu section User functionality can be accessed with all types of Chip cards 7 5 1 1 Main menu D 2 A2 a lA a2 d LA A 2 4 2 2 0 SAMPLE MODE PATIENT POS DATA END_OF_DAY WASH PRIME SETTINGS SERVICE CARD amp CREDITS A H pz ag a SELECT StaRRsed Inversa User manual Page 43 Version 1 06 MRN 141 EN mechatronics User interface 7 5 1 2 Sample screen STARSSER Inversa 24H ID READY EDTA ON ESR 60 01 08 11 14 10 et ESCAPE The sample screen shows the current sample ID and status 7 5 1 3 Menu 2 Patient pos data User PATIENT DATA POSITION DATA PRINT DATA PRINT RAW DATA SEND DATA pant E um nr ESCAPE a SELECT Page 44 StaRRsed Inversa User manual Version 1 06 MRN 141 EN mechatronics User interface 7 5 1 3 1 Menu Patient data PATIENT DATA ENTER NEXT 2 ESCAPE Use this function to check the sample status of a particular patient in the data storage of the StaRRsed Inversa Put the sample tube into the needle holder and pres
73. nics These stickers are used on the onboard reagent bottles For more information about these bottles see sections e Waste disposal on page 103 e Diluent on page 98 e X Clean on page 98 5 2 Stickers of the reagents containers StaRRsed Inversa User manual Page 35 Version 1 06 MRN 141 EN mechatronics Safety warning 6 SAFETY WARNING When there was an incident with the StaRRsed Inversa which caused damage to the instrument please notify your superior and your local equipment dealer before you continue using the instrument Example e A collision with a moving object e Something falling on the instrument e Somebody falling into or onto the Sedimentation instrument e Liquids spilling into the instrument StaRRsed Inversa User manual Page 37 Version 1 06 MRN 141 EN Rm mechatronics User interface 7 USER INTERFACE A ARROW UP key v ARROW DOWN key RR Enter mechatronics won a ENTER key 7 8 9 A Back 4 5 6 Space BACKSPACE ke v key 1 2 3 Ec es om e E ESC key 9 cS m EN CANCEL key StaRRsed Inversa User manual Pages Version 1 06 MRN 141 EN mechatronics User interface 7 1 Navigating through the menus The main menu is displayed after start up The bottom line of the display shows which keys are valid in the context of the selected menu or function To start functions or access other menus you can either e Press the required row nu
74. ns Dimensions Width Height Depth Weight without fluids 324 mm 771 mm 529 mm 23 kg StaRRsed Inversa table size Min table size Width Depth 600 mm 750 mm StaRRsed Inversa User manual Version 1 06 MRN 141 EN Page 19 Rm mechatronics Instrument description 2 2 1 CE Mark StaRRsed Inversa The CE Mark is found on the Mechatronics instrument identification plate an illustration of which is shown below with explanations The instrument identification plate is fitted at the left side of the rear panel of the StaRRsed Inversa Explanation Instrument name StaRRsed Inversa Instrument type and model Instrument serial number Electrical information Protection class Manufacturer information and Date of manufacture 9 gr c m 2 3 Accessories kit The StaRRsed Inversa comes with an accessories kit For a complete list of the the contents of accessories kit see Appendix Article reference list Inversa on page 140 Page 20 StaRRsed Inversa User manual Version 1 06 MRN 141 EN R mechatronics Installation 3 INSTALLATION Before unpacking the StaRRsed Inversa we recommend that the packaging should be checked for damage Any damage must be reported to the distributor Follow the next installation instruction steps 3 1 Unpacking Compact system 1 Cut the binding of box and take out the top protection cover 2 Remove the out box 3 Remove the accessories box 4 Remove th
75. nt only accepts chip cards of the dealer to which the instrument is configured 2 1 2 Chip card type Q Chip cards of type Q are used to operate the instrument in ownership without credit limitations and can only be used on instruments which are configured to accept the Q chip card 2 1 3 Chip card type S Chip cards of type S Supervisor card are used by lab supervisors to grant them access to important instrument settings When this type of chip card is inserted in the card reader a PIN code must be entered to unlock the protected menus 2 1 4 Chip card type T Chip cards of type T Technician card are used by service technicians to install and prepare the instrument for routine operation and to perform service functions When this type of chip card is inserted in the card reader a PIN code must be entered to unlock the protected menus Page 16 StaRRsed Inversa User manual Version 1 06 MRN 141 EN R mechatronics 2 2 Technical specification Technical specifications for the StaRRsed Inversa StaRRsed Inversa instrument models Model name Model StaRRsed Inversa 24M StaRRsed Inversa User manual Version 1 06 MRN 141 EN Instrument description Catalogue number BANG109000 Page 17 Instrument description ESR method mechatronics ESR method Westergren method Temperature compensation method R W Manley J clin Path 1957 10 354 30 minute method Rogers Medical Labor
76. nversa is switched on The software version appears at the bottom of this screen 7 2 1 Start Printout after Switch ON When a card type A E or a Q card is present in the card reader of the StaRRsed Inversa the following information will be printed after Switch ON A Switch ON configuration example printout after switching the StaRRsed Inversa ON Column 1 Column 2 Column 3 StaRRsed Inversa24M StaRRsed Inversa User manual Page 41 Version 1 06 MRN 141 EN R mechatronics User interface Line 1 123456789ABC Line 2 30 06 2011 09 00 45 Line 3 Dealer Code Line 4 D factor Line 5 Credits Line 6 Total counts Line 7 Serv count In line 8 the serials numbers of the used cards are display 7 3 Warning screen Prime PRIME LAST PRIME MORE THAN 12H AGO PRIME NOW RECOMMENDED 2 ESCAPE This warning screen appears when the StaRRsed Inversa has been idle or switched off for more than the indicated hours Press ENTER to start the function This will ensure that the fluid lines are correctly filled with diluent This function can also be started manually at a later time Page 42 StaRRsed Inversa User manual Version 1 06 MRN 141 EN mechatronics User interface 7 4 Warning screen End of day wash END_OF_DAY WASH LAST END_OF_DAY WASH MORE THAN 12H AGO END_OF_DAY WASH RECOMMENDED ESCAPE This warning screen appears when the End of day wash was not do
77. ocal service engineer Flash memory malfunction 91 Number not assigned Number not assigned 93 Number not assigned Number not assigned 95 Number not assigned Number not assigned 97 Number not assigned Number not assigned Number not assigned Number not assigned Number not assigned Number not assigned Number not assigned Number not assigned Unknown status in If this error occurs repeatedly contact End of day wash routine local service engineer Number not assigned Number not assigned Unknown status in pipette Reset the instrument If this error occurs repeatedly contact test routine local service engineer StaRRsed Inversa User manual Page 135 Version 1 06 MRN 141 EN mechatronics Appendix for StaRRsed Inversa 109 Error in pipette test routine If this error occurs repeatedly contact gt aborted ER service engineer Number not assigned 111 ATR error chip card Bad or no communication with card A e Chip card incorrectly inserted e Wrong type of chip card e Chip card reader malfunction and retry CRC stored in chip card memory Dealer code error Remove chip card Dealer code does not match with dealer and insert correct code set in instrument card Card type error Remove chip card Wrong type of chip card inserted E g and insert correct credit card inserted instead of service chip card card 115 Card not original Remove chip card In
78. ode or with EDTA anticoagulated samples EDTA mode The sodium citrate dilution takes place in a 4 1 ratio and is achieved with 3 accuracy Twenty four Westergren pipettes are housed in the carousel Each is of precision bore glass The fill line is back flushed with sodium citrate diluent Positive sample identification is achieved with a barcode reader and takes place before aspiration of the sample The temperature is corrected to the standard value of 18 C and ESR s may be read after one hour or 30 minutes A predicted one hour result is presented in the 30 minute mode Results of the test are expressed in millimeters and printed on the build in printer The main features of the StaRRsed Inversa are e Single unit with small footprint housing all units and containers e Closed compartment with a carrousel holding 24 precision bore glass Westergren pipettes measuring unit and pipette filling station e Build in printer e Chip card system e Barcode reader for sample identification e Serial parallel interface e Easy accessible keypad with light key pressure due to piezo technology e LCD screen e Battery backup memory e Accessories kit StaRRsed Inversa User manual Page 13 Version 1 06 MRN 141 EN Rm mechatronics Instrument description Page 14 StaRRsed Inversa User manual Version 1 06 MRN 141 EN RR mechatronics Instrument description 2 1 Chip card system The StaRRsed Inversa uses a
79. on sa wo 1 roo t partert saporon nn 5 Megas a replace engen none 1 no pur vd 3 On dis y at ews Acad consid mem Y A Dx 1 2 Oha buted i i i Name of person reporting insert Sigretre of person reporting nadert FESO StaR Reed incident Report V 0 1 August 2004 Issued by me Senece Depariment of Mecharoncs Copyrigt Mechatrorics B V StaRRsed Inversa User manual Page 33 Version 1 06 MRN 141 EN mechatronics Standard Operating Procedures S O P AA E 4 4 E C Declaration StaRRsed Compact Mechatronics Manufacturing B V mechatronics De Corantyn 13 P O box 225 1689 AN ZWAAG 1620 AE HOORN The Netherlands The Netherlands Telephone 31 0229 291129 Fax 31 0 229 241534 E mail sales mechatror l E C DECLARATION OF CONFORMITY kernel rer VAT number NL 8048 22 979 B01 C 0 C number 36048153 Hoom Banker Rabobank Account number 3716 23 928 Swift address RABO NL 2U IBAN NL41 RABO 0371 6239 28 Herewith we declare that the Erythrocyte Sedimentation Rate Analyser StaRRsed Inversa 24M e Is in conformity with the requirements of the following EC directives 98 79 EC IVD devices 2006 42 EC Machinery The following harmonized standards have been applied EN 12100 1 Safety of machinery Part 1 Basic terminology methodology EN 12100 2 Safety of machinery Part 2 Technical principles EN 61010 1 Safety requirements for electr equipm for meas control and lab use General requirement
80. onnncnnnnnonennnnnnnnnnnnnnnnnnnnnnnnnnnnnnnannnrnnnnns 119 14 3 Specifications for the AS232 port iiec creo eret ee 119 15 MAINTENANCE cunado 121 Me VEN rc 121 192 IVORY T M 121 15 3 Level 4 maintenance essessseseenem m meme eme ememrn mnn nnn rne rn rentrer rena 122 15 4 Level 3 maintenance sesssssesseeenm emen ner rra rr rer nme rreren 122 15 5 Level 2 maintenance acsi eni emen eme rn rne rn rne rn rnt nennen 122 15 6 Level 1 maintenance essssssseeeem m emen emen mnn rn rne nennen nenn 122 16 TROUBLE SHOOTING eseeeeeeeceeee nena rna nnn a amada anna ak aaa 4a R44 RAN 4a R44 SD Adda naa 123 16 1 General error procedure sessssssseesssseeeeeeeeee eene nnne nnne nnn 123 JS ME nn on 125 16 3 Hazy ooi a 125 16 4 Leaking pipettes aeenn mrt e tke na tel cendo Ex CK ERI I E ERE 125 o AAA N een 126 16 4 2 Disabling a pipe 126 16 4 3 Replacing a pipette anne 127 16 5 Sampling not allowed NOW cccccccccccccccceccececeeeceeeceeeceeececeeeceeeeeeseeseeseeseeeess 127 17 APPENDIX FOR STARRSED INVERSA enses ener nun nun rain heran ran nenn 129 18 WORK INSTRUCTION STARRSED INVERSA censere nnn nnn nanus 171 18 1 WI 403 Level 3 maintenance esseseeem meme rne 177 19 GLOSSARY OF TERMS eiii tese tu arose 2 ta
81. ontact local service engineer 32 Internal error If this error occurs repeatealy contact local service engineer 33 Internal error If this error occurs repeatedly contact local service engineer 34 Internal error If this error occurs repeatedly contact local service engineer 39 Number not assigned 1 40 Number not assigned EE StaRRsed Inversa User manual Page 137 Version 1 06 MRN 141 EN mechatronics Appendix for StaRRsed Inversa Appendix Warning list StaRRsed Inversa Description Remark Possible cause Warning No printer Check printer e Printer malfunction 201 Warning Printer cover Close cover e Cover open o AS 202 Warning Out of paper Put in a new paper Out of paper ulis MF NN 203 Warning Temperature Turn off printer problem e Contact local service engineer e Print head too hot e Printer malfunction 204 Warning Power supply e Voltages out of range problem e Power supply malfunction Warning printer buffer full Number not assigned Number not assigned Number not assigned Number not assigned 10 Warning Not possible to rinse Needle not in up position 211 Warning Last prime too Prime system long ago 12 Warning Last sample too Start End of day long ago E Upgrade credits i 7 E Page 138 If this error occurs repeatedly contact local service engineer e Printer too slow It is not possible to start rinsing needle
82. p The lower part shows a representation of all pipettes in the carousel counted from left to right and from top to bottom Enabled pipettes are marked with a dot O disabled pipettes are marked with a cross X The StaRRsed Inversa checks automatically for leaking pipettes by observing column height warnings that may be given with the ESR results Leaking pipettes are automatically disabled for future use and must be enabled manually Note In this example pipettes 2 and 18 are disabled Use the ARROW DOWN or ARROW UP keys and select the required pipette number then press the ENTER key to toggle the setting to the opposite of the current state EN DISABLE PIPET PIPET NUMBER 21 DISABLE ARE YOU SURE gt ESCAPE StaRRsed Inversa User manual Page 55 Version 1 06 MRN 141 EN mechatronics User interface 7 5 1 6 2 Menu Print settings PRINT SETTINGS CONTINUE LM ESCAPE Press ENTER to start the function The instrument settings are printed on the build in printer 7 5 1 7 Menu 6 Service ERROR HISTORY SOFTWARE VERSIONS DISPLAY S N mE SELECT 7 5 1 7 1 Menu Error history 1 SHOW ERROR HISTORY 2 PRINT ERROR HISTORY ur ESCAPE ae SELECT Page 56 StaRRsed Inversa User manual Version 1 06 MRN 141 EN R mechatronics User interface 7 5 1 7 1 1 Menu Show error history SHOW ERROR HISTORY 01 08 2011 15 12 00 02 09 2010 12 0
83. r 02 ETX Char 03 StaRRsed Inversa User manual Page 151 Version 1 06 MRN 141 EN mechatronics Appendix for StaRRsed Inversa Sample conformation string definition replied by the host computer to perform an ESR test sm se e s n s n se 1 2 s 4 5 6 7a 9 tora 13 4 15 16 17 8 SP Y SP os Etx Y Capital Y at position 28 of the string Sample refuse string definition replied by the host computer to skip the ESR test sm se e s n s n se 1 2 s 4 5 6 7a 9 so rr ra 3 t4 15 16 i7 8 SP N SP os ETX N Capital N at position 28 of the string If either the host computer as well the StaRRsed Inversa receives a string it should reply by sending an Acknowledge char 06 if the string is found okay If either the host computer as well the StaRRsed Inversa receives a string it should reply by sending a Non Acknowledge char 15 if the string is found faulty Sample request Checksum always ON After sending the request string the StaRRsed Inversa expects a ACK NACK seeCompact bi directional protocol definition from the Host computer e If the StaRRsed Inversa receives an ACK it will wait for the conformation string and respond with a ACK NACK according to the protocol definition e When the conformation string is received it will Respond with an ACK if the conformation string is OK and goes to the next sample Or Page 152 StaRRsed Inversa User manual Version 1 06 MRN 141 E
84. s EN 61010 2 101 Safety requirements for electr equipm for meas control and lab use Particular requirements for in vitro diagnostic IVD medical equipment EN 591 Instructions for use for in vitro diagnostic instruments for professional use EN 980 Symbols for use in the labelling of medical devices EN ISO 14971 Medical devices Application of risk management to medical devices EN ISO 13485 Medical devices Quality management systems Requirements for regulatory purposes The CE mark is first applied on this instrument model in 2009 Zwaag The Netherlands February 22 2010 R Metselaar Managing director Mechatronics Manufacturing BV By the ORGALIME GENERAL CONDITIONS S92 of August 2000 Es Ey Any other conditions are herewith explicitly resected by us EM cwn G CA 150 13485 2008 E 9001 2000 VE ZE e e dl REGED Page 34 StaRRsed Inversa User manual Version 1 06 MRN 141 EN mechatronics Labels and stickers 5 LABELS AND STICKERS 5 1 Stickers for the onboard reagents bottles STARRSED STAR SED STARRSED WASTE DILUENT X CLEAN 2500ml 1000ml 1000ml Afval Verdunningsvloeistof Reinigingsvloeistof Abfall Verd nnungsl sung Reinigungsl sung D chets Diluant tamponn Solution de nettoyage Scorie o Soluzione detergente Desecho wa sla Soluci n limpiador Residuos Solu o limpiador Biohazard RR wwrw mechatronics ni RR www mechatronics nl RR www thechatronics nl mechetronics mechatronics mechatro
85. s ENTER to get the patient ID from the barcode label or enter the ID manually and then press ENTER 7 5 1 3 2 Menu Position data POSITION DATA Pipette number 14 PIPETTE EMPTY Use this function to check the status of a particular pipette Use the ARROW UP and ARROW DOWN keys to scroll through the pipettes StaRRsed Inversa User manual Page 45 Version 1 06 MRN 141 EN mechatronics User interface 7 5 1 3 3 Menu Print data PRINT DATA T TODAY S RESULTS c YESTERDAY S RESULTS S Y 3 T J DATE p ET ps ESCAPE m SELECT an iii Press ENTER to start the function TODAY S RESULTS CONTINUE ESCAPE e or YESTERDAY S RESULTS CONTINUE Page 46 StaRRsed Inversa User manual Version 1 06 MRN 141 EN R mechatronics User interface ESCAPE Use these functions to print all sample results from the selected day on the build in printer 7 5 1 3 3 1 Menu Date DATE ESCAPE Enter the day number and press ENTER Then continue in the same way with the month year hour and minutes if applicable Note When there is no input during 60 seconds the input option is closed 7 5 1 3 4 Menu Print raw data PRINT DATA PRINT GRAPH E ESCAPE a SELECT Use these functions to print the raw measurement data of a particular sample The raw data can be used to analyse a sample in detail in case of unexpect
86. s at least daily Decontaminate waste materials before disposal Wear a BUTTONED lab coat to protect street clothes Wear gloves when hands may contact potentially infectious materials contaminated surfaces or equipment Wear eye face protection if splashes or sprays are anticipated during work outside a biological safety cabinet Transport materials outside of the laboratory using secondary containment and a cart Avoid public areas during transport Transfer materials to and from the MCG according to federal and international regulations Be familiar with written instructions for laboratory procedures and proper responses to emergencies Report spills exposures illnesses and injuries immediately StaRRsed Inversa User manual Page 29 Version 1 06 MRN 141 EN mechatronics Standard Operating Procedures S O P 4 2 S O P for working with bio hazardous materials Purpose To inform and educate all engineers that work with biohazards Effective Date July 27 2004 4 2 1 Facts and definitions Biological hazards are present in all human and animal tissues and body fluids The normal research activities carried out in a blood laboratory expose workers to human blood urine sweat semen saliva and muscle tissue For the purpose of assessing risk we assume that all volunteers to our clinical studies are not normal healthy individuals and take appropriate precautions We remain aware at all times that incre
87. s with sodium citrate anticoagulant diluent The samples are not diluted on the StaRRsed Inversa during aspiration The concentration of sodium citrate within the diluent solution in the tube should be 3 296 This is not to be confused with the required dilution rate of blood and diluent For example in a citrate tube with a total draw volume of 1 6 ml 2 5 volumes the amount of pre filled diluent must be 0 32 ml 1 volume If this information is not provided by the tube manufacturer it should be checked by the customer E 19 1 1 1 3 EDTA mode EDTA mode is used for undiluted samples collected in tubes with EDTA anticoagulant The samples are automatically diluted on the StaRRsed Inversa during aspiration The usual amount of EDTA in sample tubes is 1 8 mg per 1 ml blood 1 ml of blood weighs ca 1060 mg and the concentration of EDTA is therefore 0 1796 and well within the requirements for the EDTA mode on this instrument Bidirectional Citrate mode StaRRsed Inversa User manual Version 1 06 MRN 141 EN Glossary of Terms 19 1 1 1 4 ESR ESR is short for Erythrocyte Sedimentation Rate It is the amount of sedimentation setting of erythrocytes red blood cells in a blood column during a specified time H 19 1 1 1 5 Hazy A sedimentation is reported to be hazy when the boundary between blood plasma and erythrocytes can not be defined clearly 19 1 1 1 6 Host In this manual the term HOST is used to
88. sa receives a NACK it will send the result string again After 3 attempts it will start sending the next result e Ifthe StaRRsed Inversa does not get any response from the host timeout 10 sec it will send the result string again After 3 attempts it will stop communication and generate an error StaRRsed Inversa User manual Page 153 Version 1 06 MRN 141 EN mechatronics Appendix for StaRRsed Inversa Page 154 StaRRsed Inversa User manual Version 1 06 MRN 141 EN mechatronics Appendix Protocol MECHATRONICS 01 bidirectional MECHATRONICS 901 request workorder record ES Eu Data 125 characters es em Appendix for StaRRsed Inversa Position Data field Ee Format Comment 1 Start of text 1 STX 2 Text distinction code 8 ESRSR Left aligned followed by spaces 10 Instrument ID 20 text If applicable 30 Sample ID 40 text 70 Reserved spaces 55 text 125 Request workorder 1 text R Request Y ESR yes N ESR no 126 Space 1 text 127 Checksum 1 CS See section Checksum calculation 128 End of text 1 ETX Total 128 Text left aligned followed by spaces StaRRsed Inversa User manual Version 1 06 MRN 141 EN Page 155 mechatronics Appendix for StaRRsed Inversa ie number digits 0 9 with leading spaces Non specified positions are filled with spaces Page 156 StaRRsed Inversa User manual Version 1 06 MRN 141 EN mech
89. serted chip card is not an original Mechatronics card Card memory error Remove chip card Updated chip card memory RMA does not match with source Send chip to dealer for further inspection Card copy error Remove chip card Inserted chip card is a copy Original chip card already used to upgrade credits 118 Credit maximum error Remove chip card It is not allowed to upgrade credits Maximum of credits has been reached D factor error Remove chip card It is not allowed to upgrade credits and change D factor HIST e D factor must be between 1 and 10 000 when A to E chip card is used When Q card is used D factor must be 0 Transfer error Try again or use Software failed to transfer credits from correct chip card or to a service card e Infinite credits can not be transferred Only service cards can be used to transfer credits Communication error with service card Try again or use other service card Page 136 StaRRsed Inversa User manual Version 1 06 MRN 141 EN mechatronics Appendix for StaRRsed Inversa hm Tumbernorassonen OOO 23 Number not assigned IA 4 Number not assigned fF 5 Number not assigned fC 6 Number not assigned EN 7 E 8 2 2 2 2 Number not assigned I 2 Number not assigned fF 29 Number not assigned O Internal error If this error occurs repeatedly contact local service engineer Internal error If this error occurs repeatedly c
90. sition CAROUSEL POSITION CURRENT POS 19 SET POSITION k LEARN POSITIONS ESCAPE These functions are used to reset the correct pipette positions that are stored in memory The displayed value is the pipette number that should currently be present at the nozzle position Press the ENTER or START key to show the Input option Enter the pipette number which is actually present at the nozzle position and press ENTER to activate the action StaRRsed Inversa User manual Page 71 Version 1 06 MRN 141 EN R mechatronics User interface 7 5 2 2 6 Menu DST DST SETTING ON ESCAPE p SELECT This function is used to switch the internal clock to Daylight Saving Time also called Summertime Use the ARROW DOWN or ARROW UP keys and select the required option Then press ENTER to save the new setting Note Can only be set between 03 00 and 21 00 and when the carousel is empty 7 5 2 2 7 Menu Result at limit RESULT AT LIMIT SETTING ON E ESCAPE mm SELECT See section Results at limit errors for details of this option Use the ARROW DOWN or ARROW UP keys and select the required option Then press ENTER to save the new setting Page 72 StaRRsed Inversa User manual Version 1 06 MRN 141 EN R mechatronics User interface 7 5 2 2 8 Menu Printer results PRINTER RESULTS SETTING ON ESCAPE p SELECT T
91. strument is turned off it is good practice to carry out the Daily maintenance or at least the End of day wash procedure This will help to keep the instrument clean and almost free of bacterial growth for a period of days 10 1 End of day wash procedure The purpose of this function is to clean the inside of the pipettes from residue which may have accumulated over time In the Main Menu use the function END_OF_DAY WASH This function takes ca 30 minutes to complete All pipettes are automatically filled with X Clean When the last pipette was filled the pipettes are emptied again The function may be aborted by pressing the CANCEL key NOTE a If the function was aborted the X Clean may not have had enough opportunity to soak and clean the pipettes 11 WASTE DISPOSAL The waste container has a level sensor and as soon as the level sensor generates a waste error the waste container must be emptied The waste must be treated as potentially infectious biohazardous material and disposed of according to local regulations Preferably discard the complete waste container and replace it with a cleaned one Disclaimer Check your local environment rules about discharging the waste StaRRsed Inversa User manual Page 103 Version 1 06 MRN 141 EN Re mechatronics Waste disposal 11 1 Waste container 1 Unscrew the cap 3 Close the container with the provided cap Page 104 StaRRsed Inversa User manual
92. t response after Check protocol settings sending result Check LIMS settings e Check connection between Inversa 65 Nack received after sending result and LIMS e Check protocol settings ee u selected 7 Number not assigned EE ned SS e Check protocol settings Number not assigned 70 Number not assigned StaRRsed Inversa User manual Page 133 Version 1 06 MRN 141 EN mechatronics Appendix for StaRRsed Inversa 71 Unknown status in prime routine 7 Prime Diluent not allowed Pipette is filled with a sample Prime is Pipette not empty only allowed when the pipette is empty 73 Prime Cleaning Solution Pipette is filled with a sample Prime is not allowed Pipette not only allowed when the pipette is empty If this error occurs repeatedly contact local service engineer empty If this error occurs repeatedly contact Error in prime routine gt aborted local service engineer Flash memory erased Check settings e Flash memory malfunction Default settings are loaded 74 75 76 Checksum error Default Check settings Calculated checksum does not match settings are loaded with the checksum stored in EEPROM e Flash memory malfunction Number not assigned 78 DS2401 not detected If this error occurs repeatedly contact local service engineer e Serial number chip malfunction 9 Communication error with If this error occurs repeatedly contact DS2401 local service engine
93. te Transmission of QC codes 1 and 2 is part of an internal QC procedure which is still under development Until this procedure is introduced all samples are treated as Patient sample code 0 Aspect Transmitted code Clear 0 Hazy lt 10 1 Hazy lt 25 2 Hazy gt 25 3 Transmitted Comment code No ERROR No cells plasma found ESR Probably gt 140 mm Too many borders found Column height Measure error Bubbles on top StaRRsed Inversa User manual Version 1 06 MRN 141 EN ERROR no result transmitted ERROR no result transmitted ERROR no result transmitted WARNING WARNING o 6 Page 165 mechatronics Appendix for StaRRsed Inversa Limit error ERROR see Limit error message Note See analyzer manual for more information about limit error settings When a limit error occurs the fields for ESR 30 min ESR 60 min temperature corrected ESR and ESR 120 min are filled with spaces and thus results are not send to LIMS Together with the other data fields e g the sedimentation time the operator can see what caused the error and may or may not use the ESR values which are preserved in the limit error message Description of the limit error message L_err hhh www ttt ccc ddd e L err means limit error e hhhisthe 30 minutes ESR e WWW is the 60 minute ESR e ttt is the temperature corrected 60 minute ESR e ccc is the column height e dddis the 120 minute ESR if applicab
94. te Management MWM bin for pick up Decontamination procedures Routine At the end of each experiment or each day disinfect lab benches and any equipment Spills Small spills of biohazard material should be treated by first covering them with an absorbent paper to avoid the formation of aerosols Disinfect the spill by slowly pouring on a disinfecting solution working from the outside to the centre of the spill in a circular motion Leave the spill long enough for disinfection to take place check decontaminating instructions on the disinfectant container for time and then carefully wipe up wearing gloves Pick up any glass using forceps Once all the material has been removed disinfect the area thoroughly Inform the Technician in Charge of the spill Food No food or beverages will be brought into or consumed inside a blood laboratory at any time Accident reporting All accidents and injuries must be reported within 24 hours to the technician in Charge to the Departmental Joint Health and Safety Committee and to the Department of Environmental Health and Safety using an Incident Report from the main office or the Technician in Charge Laboratory access Access to the haematology laboratory is limited to persons who are directly involved with the testing equipment Children are not permitted in the laboratory Personal protective equipment Laboratory and maintenance personnel are expected to use a laboratory coat while work
95. the StaRRsed Inversa Reagents preparation Set up and checking the General settings Check the temperature sensor is Set room temperature Check barcode reader readability of the barcode reader Check the Pipette position 9 Priming the fluid system 10 Run first END_OF_DAY WASH 11 Check for possible leaking pipettes during the Fill and Clean 12 Start filling the carousel with blood samples and check for leaking pipettes ONOARwWN gt StaRRsed Inversa User manual Page 25 Version 1 06 MRN 141 EN R mechatronics Standard Operating Procedures S O P 4 STANDARD OPERATING PROCEDURES S O P In this section the following issues can be found e Basics of Bio safety e S O P for working with bio hazardous materials e Safety warning e StaRRsed Incident Report e E C Declaration e Labels and stickers on containers StaRRsed Inversa User manual Page 27 Version 1 06 MRN 141 EN mechatronics Standard Operating Procedures S O P 4 1 Basics of Bio safety Basic rules on bio safety in a laboratory Wash hands after handling biological materials removing gloves or before leaving work area Don t eat drink etc in the work area Never mouth pipette Take extreme precautions when sharps must be used Dispose sharps carefully and properly Conduct procedures likely to create splashes sprays or aerosols within a biological safety cabinet that is certified annually Decontaminate work surface
96. the priming cycle To start the priming manually go to the Main menu and use the function PRIME The priming cycle takes ca 2 minutes to complete Page 98 StaRRsed Inversa User manual Version 1 06 MRN 141 EN mechatronics Sample routine procedure 9 SAMPLE ROUTINE PROCEDURE This section explains the necessary procedures for preparation and processing of blood samples on the StaRRsed Inversa 9 1 Sample Mixing To ensure that the blood cells are evenly dispersed throughout the sample the sample tube must be mixed immediately before placing it in the sampling unit This can be done either manually or by using a sample tube mixer that inverts the tubes The sample tube must be fully inverted at least 7 times Do not shake the sample NOTE Ensure that the sample tube contains at least 2 ml of whole blood A 9 2 Placing sample tubes on the needle system After mixing insert the sample tube into the needle assembly with the cap downwards and the barcode label pointing towards the instrument 9 2 1 Sample tubes with barcode Start the SAMPLE MODE Push the START key Check that the scanned ID number appears on the display If the ID number does not appear on the display the barcode could not be read Bp gc StaRRsed Inversa User manual Page 99 Version 1 06 MRN 141 EN mechatronics Sample routine procedure 1 Rotate the sample tube a little bit and push the START key again or 2 Enter the I
97. truction Number 400 Page 1 of 1 Purpose Daily maintenance Safety Bio Hazard area Instrument StaRRsed Inversa Revision Draft September 2010 Prepare disinfectant if not already prepared 180 Add 10 ml bleach sodium hypochlorite to 190 ml de ionized water 596 solution This disinfectant is for cleaning of all external parts that are exposed to blood 1 Wipe the lower tube holder of the needle unit 2 Wipe the stainless steel drip plates below the pipette carousel and needle unit 3 In the Main menu use the function END OF DAY WASH 4 Check the system for leakage Page 172 StaRRsed Inversa User manual Version 1 06 MRN 141 EN Ro mechetronics Work instruction StaRRsed Inversa RR mechatronics Work instruction Number 401 Page 1 of 6 Purpose Weekly maintenance Safety Bio Hazard area Instrument Inversa Revision Draft September 2010 NOTE Chip card type S is required Prepare disinfectant if not already prepared 180 Add 10 ml bleach sodium hypochlorite to 190 ml de ionized water 5 solution This disinfectant is for cleaning of all external parts that are exposed to blood 1 Wipe the lower tube holder of the needle unit 2 Wipe the stainless steel drip plates below the pipette carousel and needle unit e In the Main menu use the function END OF DAY WASH Check the system for leakage 5 Inspect sample needle condition M
98. umberPipette number 5 XXXXX 150 Sedimentation time minutes 5 XXXXX 155 Temperature 5 XXXXX 160 Dilution rate 5 XXXXX 165 Column height mm 5 XXXXX 170 Error code 5 XXXXX See section ESR error codes 175 Limit error message results 30 text See section Limit error message 205 Reserved spaces 50 text 255 Checksum 1 CS See section Checksum calculation 256 End of text 1 ETX Total 256 Page 158 StaRRsed Inversa User manual Version 1 06 MRN 141 EN mechatronics Appendix for StaRRsed Inversa Text left aligned followed by spaces Nou number digits 0 9 with leading spaces Non specified positions are filled with spaces StaRRsed Inversa User manual Page 159 Version 1 06 MRN 141 EN Appendix for StaRRsed Inversa Sample type Transmitted code Patient sample 0 QC normal 1 QC abnormal 2 R mechatronics Note Transmission of QC codes 1 and 2 is part of an internal QC procedure which is still under development Until this procedure is introduced all samples are treated as Patient sample code 0 Aspect Transmitted code Clear 0 Hazy lt 10 1 Hazy lt 25 2 Hazy gt 25 3 Transmitted Comment code No ERROR No cells plasma found ESR Probably gt 140 mm Too many borders found Column height Measure error Bubbles on top Page 160 ERROR no result transmitted ERROR no result transmitted ERROR no result transmitted WARNING WARNING
99. y switches to 30 minutes and cannot be changed manually The actual measured 30 MINUTE result will only be printed and sent to the host computer if 30 MINUTE OUTPUT is set to on as well If this method is switched OFF the ESR time automatically switches to 60 minutes The converted Westergren standard 60 minute result is sent to the printer and to the serial port The StaRRsed Inversa performs the ESR after 30 minutes instead of 60 minutes and converts this value to a 60 minute Westergren standard The method has the advantage that sample results become available after 30 minutes to the operator however this method is not according to the Westergren method and results may deviate from the original Westergren results For conversion to a standard Westergren a table is used which correlates a 30 minute ESR to a 60 minute ESR result The method has been proposed and evaluated by Mr Richard Rogers of the Royal Berkshire Hospital Reading U K See Medical Laboratory World April 1994 Note It is not recommended to use the 30 minute method on pre citrated sample tubes StaRRsed Inversa User manual Page 107 Version 1 06 MRN 141 EN mechatronics Reporting 12 1 Protocols A protocol is a set of rules governing the communication and the transfer of data between machines as in a computer system Also a formal set of rules and procedures to be followed during a request for information before data is transferred between machines and

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